ABL90 FLEX PLUS

Instructions for use

From software version 3.5
Contents

1. Introduction

Intended use ........................................................................................................... 1

Limitations of use............................................................................................ 2
About limitations of use..............................................................................................2
Measurement of FHbF................................................................................................ 2
Operator training requirements................................................................................... 2
About this document.................................................................................................. 2
Documentation..........................................................................................................3
About hazards...........................................................................................................3
General warning and cautions..................................................................................... 3
Reference................................................................................................................. 3

2. Getting to know the analyzer

Overview of the analyzer.................................................................................. 5

Front view................................................................................................................ 5
Side and back view.................................................................................................... 6
Consumables............................................................................................................ 7
To see details about installed consumables....................................................................8
Is the analyzer ready for use?........................................................................... 8
Three important conditions......................................................................................... 8
Parameter tab colors..................................................................................................8
To access the Analyzer status screen............................................................................9
The Analyzer status screen....................................................................................... 10
Analyzer status - Traffic light colors............................................................................ 10
Messages................................................................................................................10
To find and troubleshoot messages in the Analyzer status screen................................... 11
Is the analyzer operating on battery power?................................................................ 12
Common tasks............................................................................................... 13
To log on................................................................................................................ 13
To get quick access to the start screen........................................................................13
To scan a barcode.................................................................................................... 13
To enter text........................................................................................................... 13
To select/deselect a check button...............................................................................14
To save changes...................................................................................................... 14
Menu............................................................................................................ 15
Menu structure........................................................................................................ 15
Data logs...................................................................................................... 16
About data logs....................................................................................................... 16
Overview of data logs...............................................................................................16
To access data logs.................................................................................................. 16

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3. Patient sample analysis

General warnings and cautions.................................................................................. 17

Anticoagulants........................................................................................................ 17
Good results come from good samples.............................................................. 18
What is a good sample?............................................................................................18
To get a good sample............................................................................................... 19
To mix a sample on the analyzer................................................................................ 19
Storage recommendations........................................................................................ 19
Pre-registration of samples.............................................................................. 20
About sample pre-registration................................................................................... 20
To pre-register a sample........................................................................................... 21
Analyzing patient samples............................................................................... 21
General information for obtaining successful patient sample analyses............................. 21
To analyze a sample from a syringe............................................................................22
To analyze a sample from a capillary tube................................................................... 23
To analyze a sample from a test tube......................................................................... 25
To get calculated values for FShunt and ctO2(a-v̄)........................................................ 26
Entering and editing data in the Patient identification screen................................ 27
The Patient identification screen.................................................................................27
To change the report layout in the Patient identification screen...................................... 27
To request patient data automatically when connected to a LIS/HIS system.....................27
To request patient data using Patient lookup................................................................28
To edit data in the Patient identification screen............................................................ 28
Patient results............................................................................................... 28
To find a patient result..............................................................................................28
Symbols on patient results........................................................................................ 28
About ranges and critical limits.................................................................................. 29
Status in the Patient results log................................................................................. 30
To see messages on patient results............................................................................ 30
To troubleshoot messages on results.......................................................................... 30
To see the acid-base chart for a result........................................................................ 30
Reviewing and editing patient results................................................................ 30
To filter data from the Patient results log.....................................................................30
To see trends in a patient's results............................................................................. 31
To see the audit trail on a patient result...................................................................... 31
To add a note to a patient result ............................................................................... 31
To remove a parameter from a patient result............................................................... 32
To show a parameter in a patient result...................................................................... 32
Approval and rejection of patient results..................................................................... 32
To approve a patient result........................................................................................32
To reject a patient result........................................................................................... 33
Critical limit notification.................................................................................. 33
About Critical limit notification................................................................................... 33
To enable Critical limit notification.............................................................................. 33
To use Critical limit notification.................................................................................. 33
Pending results log...................................................................................................34
To access the Pending results log............................................................................... 34
Input fields for the Patient report layout......................................................................34
References..............................................................................................................34

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4. Replacements and maintenance

General warnings and cautions.................................................................................. 37

Types of consumables...............................................................................................37
To order products for use with your analyzer............................................................... 38
Replacement intervals for consumables and Inlet Connector Gasket................................38
Replacements.................................................................................................... 38
Solution Pack................................................................................................. 38
To see the Solution Pack status..................................................................................38
To replace the Solution Pack...................................................................................... 39
Can a Solution Pack be used again?............................................................................40
Status logs............................................................................................................. 41
To print Solution Pack status logs............................................................................... 41
To export Solution Pack status logs............................................................................ 41
Sensor Cassette............................................................................................. 41
To see the Sensor Cassette status.............................................................................. 41
To replace the Sensor Cassette.................................................................................. 41
Calibration frequency after a Sensor Cassette SC90 replacement ...................................42
Can a Sensor Cassette be used again?........................................................................42
Status logs............................................................................................................. 43
To print Sensor Cassette status logs........................................................................... 43
To export Sensor Cassette status logs.........................................................................43
Thermal printer paper..................................................................................... 43
To replace the thermal printer paper...........................................................................43
Protection of printed data......................................................................................... 44
Inlet Module.................................................................................................. 44
To replace the Inlet Module....................................................................................... 44
Inlet Gasket Holder........................................................................................ 46
To replace the Inlet Gasket Holder..............................................................................46
Inlet Probe.................................................................................................... 47
To replace the Inlet Probe......................................................................................... 47
Inlet Connector Gasket................................................................................... 49
To replace the Inlet Connector Gasket........................................................................ 49
Maintenance...................................................................................................... 51
Cleaning....................................................................................................... 51
Cleaning - when is it necessary?................................................................................ 51
To clean the inlet gasket........................................................................................... 52
To clean the touch screen......................................................................................... 52
To clean the analyzer exterior....................................................................................52
To clean the QUALICHECK Opener/Adapter..................................................................53
Disinfecting................................................................................................... 53
Disinfection - when is it necessary?............................................................................ 53
To disinfect the touch screen .................................................................................... 53
To disinfect the analyzer exterior............................................................................... 54
To disinfect the fluid transport system........................................................................ 54
Battery......................................................................................................... 54
To recharge the analyzer battery................................................................................54
To install and service the battery................................................................................54
Disposal........................................................................................................ 55
To dispose of the analyzer.........................................................................................55

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Connecting peripherals................................................................................... 55
To connect a USB external keyboard / mouse.............................................................. 55
To connect a non-USB (PS/2) external keyboard or mouse............................................ 55
To connect an external barcode reader........................................................................55
To connect the analyzer to a network..........................................................................56
Reference............................................................................................................... 56

5. Quality control

Overview of quality control management.................................................................... 57

To find the status of QC measurements.......................................................................57
Symbols that show the status of QCs..........................................................................57
Automatic quality control management.................................................................. 57
About automatic quality control management.............................................................. 57
About system checks................................................................................................58
Overview of automatic quality management................................................................ 58
Built-in QC.................................................................................................... 59
About built-in QC measurements................................................................................59
Built-in QC measurement frequency........................................................................... 60
To request an unscheduled built-in QC measurement.................................................... 60
Built-in QC results.......................................................................................... 60
Status of built-in QC measurements........................................................................... 60
To find a built-in QC result........................................................................................ 61
Symbols on built-in QC results...................................................................................61
To see messages on built-in QC results....................................................................... 61
To troubleshoot messages on built-in QC results...........................................................62
Quality control management done by operators...................................................... 62
Quality control management that can be done by operators...........................................62
Ampoule-based QC measurements................................................................... 62
QC solutions for ampoule-based measurements........................................................... 62
How to get good ampoule-based QC measurement results............................................ 63
To prepare a Radiometer QC ampoule for use.............................................................. 63
To do a Radiometer ampoule-based QC measurement from the Analyzer status screen......65
To do an ampoule-based QC measurement from the start screen................................... 67
To edit QC identification data.....................................................................................68
Ampoule-based QC results.............................................................................. 69
Status of ampoule-based QC measurements................................................................69
To find an ampoule-based QC result........................................................................... 69
Symbols on ampoule-based QC results....................................................................... 69
To see messages on ampoule-based QC results............................................................69
To troubleshoot messages on results.......................................................................... 70
Calibration verification.........................................................................................70
About calibration verification..................................................................................... 70
Frequency of calibration verification........................................................................... 70
Stage 1 - Analyzing different levels of control solution......................................... 71
To prepare a Radiometer calibration-verification ampoule for use....................................71
To do a calibration-verification measurement............................................................... 72
Stage 2 - Using results to verify reportable ranges.............................................. 73
To find a calibration-verification measurement result.................................................... 73
Symbols on calibration-verification measurement results...............................................74

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To temperature correct calibration-verification results based on Range+ QUALICHECK

measurements........................................................................................................ 74
To use temperature-corrected calibration-verification results..........................................75
To temperature correct QUALICHECK7+ pH, pO2 and pCO2 control ranges ...................... 75
To age correct QUALICHECK7+ control ranges for cCrea ...............................................76
To use corrected QUALICHECK7+ control ranges.......................................................... 77
To temperature correct pH, pCO2 and pO2 results based on QUALICHECK7+ material........78
To age correct cCrea results based on QUALICHECK7+ material .................................... 78
Stage 3 - Changing reportable ranges............................................................... 79
To change the reportable range of parameters............................................................. 79
Reviewing QC statistics....................................................................................... 79
To find and print QC statistics.................................................................................... 79
QC plots................................................................................................................. 80
To find a QC plot......................................................................................................80
To filter data from the Quality control log.................................................................... 81
To see trends in QC results........................................................................................81
WDC file export..............................................................................................81
About WDC............................................................................................................. 81
To export WDC files..................................................................................................81
Analyzing QC solutions in other modes.............................................................. 82
About analyzing QC solutions in other modes...............................................................82
To temperature correct results based on QUALICHECK5+ solutions................................. 82

6. Calibration

Overview of calibrations............................................................................................83
Frequency of automatic calibrations............................................................................83
To find the status of calibrations................................................................................ 84
Symbols that show the calibration status.................................................................... 84
Automatic calibrations.....................................................................................85
To request an unscheduled calibration from the Analyzer status screen........................... 85
To request an unscheduled calibration from the menu................................................... 85
Manual tHb calibrations................................................................................... 85
To do a tHb calibration..............................................................................................85
Calibration results.......................................................................................... 87
To find a calibration result......................................................................................... 87
Identification of calibrations in the Calibration log screen...............................................87
Understanding calibration results............................................................................... 88
To see messages on a calibration result...................................................................... 88
To troubleshoot messages on results.......................................................................... 88
Reviewing calibration results............................................................................ 88
To filter data from the Calibration log..........................................................................88
To see trends in calibration results............................................................................. 89
Status in the Calibration log screen............................................................................ 89

7. Troubleshooting

Troubleshooting - when is it necessary?...................................................................... 91

About guided troubleshooting.................................................................................... 91
To get out of Operator Action Needed mode.................................................................91
To get out of Troubleshooting needed mode.................................................................91

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To get out of Intervention Required mode................................................................... 91

Troubleshooting modes - causes................................................................................ 91
To find and troubleshoot messages in the Analyzer status screen................................... 92
To flush the fluid transport system............................................................................. 93
Operator actions requested in analyzer messages............................................... 96
To request a tubing refill........................................................................................... 96
To request a liquid sensor adjustment.........................................................................96
To request a pump calibration....................................................................................96
To request a rinse.................................................................................................... 96
Automatic and manual flush ................................................................................ 96
To request an automatic flush of the analyzer ............................................................. 96
To perform a manual flush of the analyzer ..................................................................96
Troubleshooting Analyzer messages.................................................................. 96
To troubleshoot Analyzer messages............................................................................ 96
Analyzer messages.................................................................................................. 97
Activity log.................................................................................................. 135
About the Activity log............................................................................................. 135
To troubleshoot messages in the Activity log.............................................................. 135
To see activities in the Activity log............................................................................ 135
To add a message to the Activity log.........................................................................135
To filter activities from the Activity log...................................................................... 136
Analyzer service........................................................................................... 136
For service............................................................................................................ 136
To find the installation number (serial number) of the analyzer.....................................136
To find the version of software installed.....................................................................136

8. Shutting down, moving and restarting the analyzer

Shutdown............................................................................................................. 137
Temporary shutdown of the analyzer............................................................... 137
When to do a temporary shutdown........................................................................... 137
To do a temporary shutdown................................................................................... 137
Long-term shutdown of the analyzer............................................................... 137
When to do a long-term shutdown............................................................................137
To do a long-term shutdown ................................................................................... 138
Storing the analyzer......................................................................................139
To store the analyzer.............................................................................................. 139
Moving the analyzer...................................................................................... 140
To move an analyzer that has a charged battery.........................................................140
To move an analyzer that does not have a battery...................................................... 140
Restarting the analyzer................................................................................. 140
To restart the analyzer after a temporary shutdown.................................................... 140
To restart the analyzer after a long-term shutdown.....................................................140

9. Setup

Setup menu structure.............................................................................................143

To print setups.......................................................................................................144
Analyzer configuration................................................................................... 144
Analyzer configuration............................................................................................ 144
To change the analyzer configuration........................................................................ 144

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Managing operators...................................................................................... 144

To select the logon procedure.................................................................................. 144
Access profiles.......................................................................................................145
To edit an access profile.......................................................................................... 145
Anonymous use..................................................................................................... 145
To set up anonymous use........................................................................................146
Default operators................................................................................................... 146
To add an operator................................................................................................. 146
To remove an operator............................................................................................147
To set a logoff time for all operators......................................................................... 148
Centralized user management..................................................................................148
To set up centralized user management.................................................................... 148
Managing patient profiles............................................................................... 149
Patient profiles log................................................................................................. 149
To see the data saved in a patient profile...................................................................149
To find a patient profile........................................................................................... 149
To edit a patient profile........................................................................................... 149
To add a new patient profile.................................................................................... 149
To delete a patient profile........................................................................................149
Analyzer operations........................................................................................... 150
To lock the analyzer............................................................................................... 150
To unlock the analyzer............................................................................................ 150
To lock/unlock parameters for measurement..............................................................150
To show a message on the analyzer screen................................................................150
Sample counter............................................................................................ 151
To see an overview of measurements and tests done on the analyzer............................151
Sample counter..................................................................................................... 151
To reset the counters in the User column...................................................................151
Analyzer settings.......................................................................................... 151
To set up corrective actions on system messages....................................................... 151
To enable data to be scanned from barcodes..............................................................152
To create a heading for printed data......................................................................... 152
To enable the screen saver...................................................................................... 152
To set the time and date......................................................................................... 152
To set the acoustic signals....................................................................................... 153
To mute all acoustic signals..................................................................................... 153
To change the screen language................................................................................ 153
To select a regional setting...................................................................................... 153
To set the barometric pressure.................................................................................154
To log all measurement activities..............................................................................154
Analysis setup.................................................................................................. 154
Analysis modes............................................................................................ 154
Syringe modes...................................................................................................... 154
To edit a syringe mode............................................................................................154
To create a new syringe mode..................................................................................155
To remove a measurement mode............................................................................. 156
To select a default measurement mode..................................................................... 156
To select a specific patient report layout for an analysis mode...................................... 156
To set up a calibration-verification mode................................................................... 157
To set up an ampoule QC mode................................................................................157
Capillary modes..................................................................................................... 157
To edit a capillary mode.......................................................................................... 157

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Ranges and critical limits............................................................................... 158

About ranges and critical limits................................................................................ 158
About reference ranges...........................................................................................159
Reference range of measured parameters..................................................................159
About critical limits.................................................................................................159
To set the limits for patient age groups..................................................................... 159
To set up reference ranges and critical limits..............................................................160
About reportable ranges..........................................................................................160
To set up reportable ranges..................................................................................... 160
About range of indication........................................................................................ 161
Sample pre-registration................................................................................. 161
About sample pre-registration..................................................................................161
To set up sample pre-registration............................................................................. 161
Sample age evaluation.................................................................................. 161
About sample age evaluation................................................................................... 161
Maximum sample age............................................................................................. 162
To set a maximum sample age.................................................................................162
Max sample age.....................................................................................................162
Patient report layouts.................................................................................... 162
About patient report layouts.................................................................................... 162
To create a patient report layout.............................................................................. 163
To change a patient result layout..............................................................................164
To create extra items for use in patient report layouts................................................. 165
To select a patient report layout as default................................................................ 165
To automatically change the temperature units.......................................................... 166
To edit a patient report layout..................................................................................166
To create a patient report layout for FShunt and ctO2(a-v̄)........................................... 167
Patient result settings................................................................................... 167
To set up automatic printing of acid-base charts......................................................... 167
Approval and rejection of patient results................................................................... 168
To enable patient result approval/rejection................................................................ 168
Parameter settings............................................................................................ 168
To show the parameter bar......................................................................................168
To hide the parameter bar....................................................................................... 168
To enable/disable a parameter................................................................................. 168
To set up measuring units for parameters..................................................................169
To repress a parameter........................................................................................... 169
To suppress out-of-range results.............................................................................. 169
To fix the number of decimals used in blood-gas results.............................................. 169
To enable HbF corrections....................................................................................... 170
To enable the estimation of derived parameters......................................................... 170
Editing the slope and offset of a parameter...................................................... 170
Operator-defined corrections (offset and slope).......................................................... 170
Recommendations about samples to use................................................................... 171
Limits for slope and offset values............................................................................. 172
To edit the offset and slope for a parameter...............................................................173
Calibration settings....................................................................................... 174
Details about calibration frequency........................................................................... 174
To edit the calibration schedule................................................................................ 175
To link the built-in QC schedule to the calibration schedule.......................................... 176
To set up corrective actions for overdue scheduled calibrations.....................................176

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Quality control.................................................................................................. 176

Glossary of quality control terms.............................................................................. 176
Registration of QC solutions........................................................................... 177
Why is it necessary to register QC solutions?............................................................. 177
About registration of QC solutions............................................................................ 177
To register a Radiometer QC solution for ampoule-based QC measurements...................177
Data saved during registration of Radiometer QC solutions.......................................... 178
To register a non-Radiometer QC solution..................................................................179
Data saved during registration of non-Radiometer QC solutions.................................... 179
Quality control solutions................................................................................ 179
To set up the temperature field for QC measurements................................................. 179
Scheduled QC measurements......................................................................... 180
To schedule ampoule-based QC measurements.......................................................... 180
To edit the schedule for ampoule-based QC measurements.......................................... 180
Built-in QC measurement frequency......................................................................... 181
To edit the schedule for built-in QC measurements..................................................... 181
To request ampoule-based QC measurements after replacements................................. 183
Corrective actions on QC results..................................................................... 183
To set up corrective action for errors in QC results...................................................... 183
To set up corrective actions for overdue scheduled QC measurements........................... 184
To apply operator-defined corrections to QC results.................................................... 184
To set up corrective action for errors in built-in QC measurements................................ 184
QC statistics................................................................................................ 185
To set up automatic print of built-in QC statistics........................................................ 185
Statistical factor.....................................................................................................185
To set the statistical factor...................................................................................... 185
Westgard Rules............................................................................................ 185
About Westgard Rules.............................................................................................185
Types of Westgard Rule ..........................................................................................185
Description of the lines used in Westgard rule illustrations........................................... 185
Westgard rules and corrective actions....................................................................... 186
To set up and enable Westgard Rules........................................................................ 187
To disable/enable Westgard rules............................................................................. 188
RiLiBÄK rules............................................................................................... 188
About RiLiBÄK rules................................................................................................188
To add a new RiLiBÄK rule....................................................................................... 188
To apply all RiLiBÄK rules........................................................................................ 189
To edit a RiLiBÄK rule............................................................................................. 189
To remove a RiLiBÄK rule........................................................................................ 190
Analyzer-specific control ranges...................................................................... 190
About analyzer-specific control ranges...................................................................... 190
How to establish analyzer-specific control ranges....................................................... 190
Stage 1: To do 20 ampoule-based QC measurements..................................................191
Stage 2: To enable the use of fixed standard deviations.............................................. 191
Stage 3: To use the analyzer to change control ranges to analyzer-specific control
ranges..................................................................................................................191
To manually change control ranges to analyzer-specific control ranges.......................... 192
Maintenance setup............................................................................................ 193
About mandatory and operator-defined activities........................................................193
Mandatory maintenance activities................................................................... 193
Other activities...................................................................................................... 193
To schedule other activities......................................................................................193

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To set up corrective action for overdue Other activities................................................194

Operator-defined activities............................................................................. 194
Operator activities..................................................................................................194
To set up an operator activity.................................................................................. 195
To set up corrective action for pending operator activities............................................ 195
To delete an operator activity...................................................................................195
Maintenance planning....................................................................................195
To plan maintenance activities................................................................................. 195
Replacement warnings.................................................................................. 196
To set up replacement warnings............................................................................... 196
Note fields................................................................................................... 196
To create standard texts for use in Note fields............................................................ 196
To edit standard texts for use in Note fields............................................................... 196
To delete standard texts for use in Note fields............................................................ 196
Communications........................................................................................... 197
Data security.........................................................................................................197
LIVE Connect.........................................................................................................197
To set up a LIS/HIS connection................................................................................ 198
To set up a AQURE/RADIANCE connection................................................................. 198
Patient data from a LIS/HIS or AQURE/RADIANCE system........................................... 198
To set up automatic requests for patient data............................................................ 199
To set up automatic transmission of data to a system................................................. 199
To enable manual patient data requests using Patient lookup....................................... 199
Printers....................................................................................................... 200
To set up automatic printing.................................................................................... 200
To install an external printer for the analyzer............................................................. 200
To edit the name of a printer................................................................................... 200
Data logs and archives.................................................................................. 200
About data logs and archived data logs..................................................................... 200
To set up automatic archiving.................................................................................. 201
File format of exported data logs and archived data logs............................................. 201
To export data logs.................................................................................................201
To export data from Archived data logs..................................................................... 202
To create disc space by exporting and deleting archives.............................................. 202
To import archived data logs....................................................................................202
Data backup and restoration.......................................................................... 203
Backup................................................................................................................. 203
Destinations for backup data................................................................................... 203
To schedule automatic backups................................................................................ 203
To do a manual backup........................................................................................... 203
To restore data from a backup................................................................................. 203
Saving and loading setups............................................................................. 204
To save the setup...................................................................................................204
To load a setup...................................................................................................... 204
To restore Radiometer default settings...................................................................... 204
Radiometer default settings........................................................................... 205
Operators and profiles - default settings....................................................................205
Alarm sound (acoustic signal) settings for events - default settings...............................206
Language - default setting.......................................................................................206
Analysis setup – default settings.............................................................................. 206
Parameters - default settings................................................................................... 208

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Measurement units - default settings........................................................................ 209

Calibration schedule - default settings.......................................................................210
Quality control setups - default settings.................................................................... 210
Replacement setups - default settings.......................................................................211
Communication setup - default settings.................................................................... 211
User-defined patient data items - default settings.......................................................211
Corrective actions – default settings......................................................................... 212
Miscellaneous setup - default settings....................................................................... 212
Printer setup - default settings.................................................................................213
Automatic printing - default settings......................................................................... 213
Automatic archiving - default settings....................................................................... 213
Automatic backup - default setting........................................................................... 214
Setups with no default settings................................................................................ 214
References............................................................................................................ 214

10. Performance characteristics

Measured parameters – definitions........................................................................... 215

About performance characteristics.................................................................. 216
Overview of performance characteristics................................................................... 216
Uncertainty in performance characteristics................................................................ 216
To convert an uncertainty at a 68 % confidence level.................................................. 217
Bias..................................................................................................................... 217
Repeatability and reproducibility.............................................................................. 218
Coefficient of variation (CV %).................................................................................218
Confidence intervals............................................................................................... 219
Total analytical error...............................................................................................219
About performance tests................................................................................219
Test conditions.......................................................................................................219
Reference methods/materials.................................................................................. 220
Performance test results................................................................................ 222
Rounding rules...................................................................................................... 222
pH performance test results.................................................................................... 222
pCO2 performance test results................................................................................. 223
pO2 performance test results................................................................................... 224
cK+ performance test results................................................................................... 226
cNa+ performance test results................................................................................. 227
cCl– performance test results...................................................................................227
cCa2+ performance test results................................................................................ 229
cGlu performance test results.................................................................................. 230
pO2 levels - how they affect cGlu results................................................................... 235
cLac performance test results.................................................................................. 236
ctHb performance test results.................................................................................. 239
sO2 performance test results....................................................................................240
FO2Hb performance test results............................................................................... 241
FCOHb performance test results...............................................................................242
FMetHb performance test results..............................................................................243
FHHb performance test results.................................................................................244
FHbF performance test results................................................................................. 245
ctBil performance test results ................................................................................. 246
ctBil external test results........................................................................................ 248
cUrea performance test results................................................................................ 250

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cBUN performance test results................................................................................. 251

cCrea performance test results................................................................................ 251
Precision and bias of aqueous QC system – QUALICHECK7+........................................ 252
Interference test results................................................................................ 256
Interference tests.................................................................................................. 256
pH/blood gas.........................................................................................................257
Electrolytes........................................................................................................... 257
Metabolites........................................................................................................... 260
Oximetry parameters..............................................................................................275
ctBil sensitivity for MCHC variations.......................................................................... 283
Traceability.................................................................................................. 285
Traceability to the primary standards at Radiometer....................................................285
pH traceability....................................................................................................... 285
pCO2 and pO2 traceability........................................................................................285
cK+ and cNa+ traceability........................................................................................ 285
cCa2+ traceability................................................................................................... 286
cCl– traceability..................................................................................................... 286
cGlu traceability.....................................................................................................286
cLac traceability.....................................................................................................286
ctHb traceability.....................................................................................................286
Saturation – sO2 = 100 % – traceability.................................................................... 287
Saturation – sO2 = 0 % – traceability....................................................................... 287
FCOHb – normal value - traceability..........................................................................287
FCOHb – 100 % - traceability.................................................................................. 287
FMetHb traceability................................................................................................ 287
FHbF traceability.................................................................................................... 287
ctBil traceability..................................................................................................... 288
cUrea/BUN traceability............................................................................................288
cCrea traceability................................................................................................... 288
References............................................................................................................ 288

11. Derived and input parameters

Parameter types.................................................................................................... 291

Parameter symbols.................................................................................................291
Input parameters – definitions and acceptable values................................................. 291
Derived parameters................................................................................................292
Default values of parameters................................................................................... 293
Definitions of derived parameters................................................................... 294
Acid-base derived parameters – definitions................................................................294
Oximetry derived parameters – definitions................................................................ 295
Oxygen derived parameters - definitions................................................................... 295
Electrolyte derived parameters – definitions...............................................................297
Data necessary to derive electrolyte parameters........................................................ 297
Metabolite derived parameters – definitions............................................................... 297
Calculation of derived parameters................................................................... 298
Sample type..........................................................................................................298
Units and symbols used in equations........................................................................ 298
Units of derived parameters – metabolite parameters................................................. 299
Equations........................................................................................................ 299
Equations for acid-base parameters................................................................ 299
pH(T) - equation 1................................................................................................. 299

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cH+(T) - equation 2................................................................................................299

pCO2(T) - equation 3.............................................................................................. 299
cHCO3–(P) - equation 4...........................................................................................300
cBase(B) - equation 5.............................................................................................300
cBase(B,ox) - equation 6.........................................................................................300
cBase(Ecf) - equation 7.......................................................................................... 300
cBase(Ecf,ox) - equation 8...................................................................................... 300
cHCO3–(P,st) - equation 9........................................................................................ 300
ctCO2(P) - equation 10........................................................................................... 301
ctCO2(B) - equation 11........................................................................................... 301
pH(st) - equation 12...............................................................................................301
Equations for electrolyte parameters............................................................... 301
Anion Gap, K+ equation 43...................................................................................... 301
Anion Gap - equation 44......................................................................................... 301
cCa2+(7.4) - equation 45........................................................................................ 301
Equations 46 and 47...............................................................................................302
mOsm - equation 48.............................................................................................. 302
Equations for oxygen parameters.................................................................... 302
pO2(T) - equation 14.............................................................................................. 302
pO2(A) - equation 15.............................................................................................. 303
pO2(A,T) - equation 16........................................................................................... 303
pO2(a)/FO2(I) - equation 17.................................................................................... 303
pO2(a,T)/ FO2(I) - equation 18................................................................................ 303
p50 - equation 19.................................................................................................. 303
p50(T) - equation 20.............................................................................................. 304
p50(st) - equation 21............................................................................................. 304
pO2(A-a) - equation 22........................................................................................... 304
pO2(A-a,T) - equation 23........................................................................................ 305
pO2(a/A) - equation 24........................................................................................... 305
pO2(a/A,T) - equation 25........................................................................................ 305
pO2(x) or px - equation 26...................................................................................... 305
pO2(x,T) - equation 50........................................................................................... 305
ctO2 - equation 27................................................................................................. 306
ctO2(a-v̄) - equation 28.......................................................................................... 306
BO2 - equation 29.................................................................................................. 307
ctO2(x) or cx - equation 30...................................................................................... 307
ḊO2 - equation 31.................................................................................................. 307

Q̇t - equation 32.................................................................................................... 307

V̇O2 - equation 33.................................................................................................. 308

FShunt - equation 34..............................................................................................308
FShunt(T) - equation 35......................................................................................... 308
RI - equation 36.................................................................................................... 309
RI(T) - equation 37................................................................................................ 309
Qx - equation 38.................................................................................................... 310
V(B) - equation 42................................................................................................. 310
VCO2/V(dry air) - equation 51................................................................................. 310
VO2/V(dry air) - equation 52................................................................................... 311
Equations for oximetry parameters................................................................. 311
FHHb - equation 41................................................................................................ 311
FO2Hb - equation 40...............................................................................................311
sO2 - equation 39...................................................................................................311

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Contents ABL90 FLEX PLUS: Instructions for use

Hct - equation 13................................................................................................... 311

FHbF - equation 49................................................................................................ 312
Equations for metabolite parameters............................................................... 312
GFR if AA - equation 53.......................................................................................... 312
GFR if non AA - equation 54.................................................................................... 312
GFR if JP - equation 55........................................................................................... 312
GFR Schwartz - equation 56.................................................................................... 312
GFRmdrd AA - equation 57......................................................................................313
GFRmdrd nonAA - equation 58.................................................................................313
GFRckd AA - equation 59........................................................................................ 313
GFRckd nonAA - equation 60................................................................................... 313
Urea/BUN-to-creatinine ratio - equation 61................................................................313
Converting results to other units ............................................................................. 313
Oxyhemoglobin dissociation curve...................................................................314
ODC equations...................................................................................................... 314
The ODC reference position..................................................................................... 315
The ODC displacement............................................................................................315
The actual ODC position..........................................................................................316
To determine the actual displacement....................................................................... 317
Coordinates on the ODC..........................................................................................319
References............................................................................................................ 319

12. Principles of operation

General construction..................................................................................... 321

Sensors................................................................................................................ 321
General measurement principles..................................................................... 321
Introduction.......................................................................................................... 321
Activity vs. concentration........................................................................................ 322
Fluid transport system............................................................................................ 322
Measurement process............................................................................................. 323
Rinse process........................................................................................................ 324
Calibration................................................................................................... 324
Definition.............................................................................................................. 324
Frequency.............................................................................................................324
Calibration solutions............................................................................................... 324
The calibration equation................................................................................ 324
About the calibration equation................................................................................. 324
Plotting a calibration line......................................................................................... 325
Sensitivity, status and drift............................................................................ 325
Sensitivity.............................................................................................................325
Status.................................................................................................................. 327
Drift..................................................................................................................... 327
Reference electrode...........................................................................................327
Background information - reference electrode...................................................327
Purpose................................................................................................................ 327
Fixed potential.......................................................................................................327
Use ..................................................................................................................... 328
Construction - reference electrode.................................................................. 328
Construction..........................................................................................................328

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pH and electrolyte sensors................................................................................. 328

Construction - pH and electrolyte sensors........................................................ 328
Construction..........................................................................................................328
Measurement principles - pH and electrolyte sensors......................................... 329
Potentiometric measurement principle...................................................................... 329
Electrode chain...................................................................................................... 329
Electrode chain potential......................................................................................... 330
Derived potential................................................................................................... 330
Ion-sensitive membrane ........................................................................................ 330
Nernst equation..................................................................................................... 330
Activity and concentration....................................................................................... 331
Calibration - pH and electrolyte sensors........................................................... 331
Calibrations of pH and electrolyte sensors................................................................. 331
Calculation of pH and electrolytes sensitivity..............................................................331
Measurement - pH and electrolyte sensors....................................................... 331
Calculation of pH and electrolyte values.................................................................... 331
Sensor response stability........................................................................................ 332
pCO2 sensor..................................................................................................... 332
Construction - pCO2 sensor............................................................................ 332
Construction..........................................................................................................332
Measurement principle - pCO2 sensor.............................................................. 333
Electrode chain...................................................................................................... 333
Electrode chain potential......................................................................................... 333
Measurement process in the pCO2 sensor.................................................................. 333
Calibration - pCO2 sensor...............................................................................334
Calibrations of the pCO2 sensor ...............................................................................334
Calibration levels................................................................................................... 334
Calculation of pCO2 sensitivity................................................................................. 334
Measurement - pCO2 sensor...........................................................................335
Calculation of pCO2 values...................................................................................... 335
Sensor response stability........................................................................................ 335
pO2 sensor....................................................................................................... 335
Measurement principle - pO2 sensor................................................................ 335
Optical system for pO2............................................................................................335
Measurement sequence.......................................................................................... 336
Calculations.......................................................................................................... 336
Calibration - pO2 sensor................................................................................ 336
Overview of pO2 calibrations....................................................................................336
Sensitivity.............................................................................................................336
Status.................................................................................................................. 337
Measurement - pO2 sensor.............................................................................337
Calculation of pO2 values........................................................................................ 337
Glu and Lac sensors.......................................................................................... 338
Construction - Glu and Lac sensors................................................................. 338
Construction - Glu and Lac sensors...........................................................................338
Zero current - Glu and Lac sensors........................................................................... 338
Calibration - Glu and Lac sensors.................................................................... 339
Calculation of sensitivity – Glu and Lac sensors.......................................................... 339
Measurement - Glu and Lac sensors................................................................ 339
Calculation of Glu and Lac values............................................................................. 339
Sensor response stability of the glucose and lactate sensors........................................ 339

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Contents ABL90 FLEX PLUS: Instructions for use

Measurement principle - Glu and Lac sensors................................................... 340

Amperometric measurement principle for Glu and Lac sensors..................................... 340
Electrode chain – Glu and Lac sensors.......................................................................340
Measurement process – Glu and Lac......................................................................... 340
Creatinine sensors........................................................................................ 341
2-sensor configuration............................................................................................ 341
Construction - Creatinine sensors............................................................................. 341
Zero current - cCrea............................................................................................... 342
Determination of analyte levels in the calibrators........................................................342
Calculation of sensitivity – Creatinine........................................................................342
Calculation of cCrea values......................................................................................343
Measurement process – creatinine............................................................................343
Electrode chain – creatinine.....................................................................................344
Sensor response stability of the creatinine sensors..................................................... 344
Urea/BUN sensors.........................................................................................344
Construction..........................................................................................................344
Potentiometric measurement principle...................................................................... 345
Electrode chain potential......................................................................................... 345
Derived potential................................................................................................... 345
Enzyme layer........................................................................................................ 346
Ion-sensitive membrane......................................................................................... 346
Nernst equation..................................................................................................... 346
Calibration of the urea/BUN sensor...........................................................................346
Calculation of cUrea/BUN values.............................................................................. 346
Sensor response stability of the urea/BUN sensor....................................................... 347
ctHb and derivates............................................................................................ 347
Description of the optical system.................................................................... 347
Measured parameters............................................................................................. 347
Construction..........................................................................................................347
Measurement cycle.................................................................................................348
Lambert-Beer's law................................................................................................ 348
Absorbance........................................................................................................... 349
Total absorbance....................................................................................................349
Continuous spectrum..............................................................................................349
Spectrum examples................................................................................................350
Determining concentrations..................................................................................... 350
Matrix of constants.................................................................................................351
Calibration of the optical system..................................................................... 351
Calibration materials.............................................................................................. 351
Zero point............................................................................................................. 351
Cuvette path length................................................................................................351
Correcting for interferences............................................................................351
HbF versus HbA..................................................................................................... 351
Deviation of results................................................................................................ 352
Detecting HbF........................................................................................................352
Correcting for HbF..................................................................................................352
Repressing spectra................................................................................................. 352
Residual spectrum..................................................................................................353
Measurement and corrections......................................................................... 353
Calculation of the values of the oximetry parameters.................................................. 353
Bilirubin................................................................................................................353
Restrictions .......................................................................................................... 354

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Corrections for ctHb............................................................................................... 354

Corrections for ctBil................................................................................................355
References............................................................................................................ 355

13. Specifications

Analyzer specifications.................................................................................. 357

Ranges of indication and reportable ranges................................................................357
Measurement precision within specified ranges...........................................................359
Product specifications............................................................................................. 363
Environmental specifications....................................................................................366
Power-supply cords................................................................................................ 367
Consumables specifications................................................................................ 368
Solution Pack............................................................................................... 368
Function of the Solution Pack...................................................................................368
Solution Pack specifications..................................................................................... 368
Sensor Cassette........................................................................................... 370
Function of the Sensor Cassette............................................................................... 370
Sensor Cassette specifications................................................................................. 370

14. Graphical symbols

Explanation of graphical symbols/icons..................................................................... 373

15. Ordering information

Solution Packs – code numbers................................................................................ 377

Sensor Cassettes – code numbers............................................................................ 377
Spare parts and accessories - code numbers..............................................................378
Quality control products – code numbers...................................................................378
Recommended Radiometer sampling devices - code numbers.......................................379
Power-supply cords - code numbers......................................................................... 381

16. Legal information

Patents and trademarks................................................................................. 383

Patents................................................................................................................. 383
Trademarks........................................................................................................... 383
Legal notices................................................................................................ 383
System performance.............................................................................................. 383
Third-party software and trademarks........................................................................ 383
Warranties and disclaimer....................................................................................... 383
Confidentiality....................................................................................................... 384
Changes............................................................................................................... 384
End-user license agreement with Microsoft................................................................ 384

Index 387

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xviii 996-686C
Introduction 1
Intended use

The ABL90 FLEX PLUS analyzer is a portable, automated analyzer that measures pH,
blood gases, electrolytes, glucose, lactate, bilirubin, creatinine, urea/BUN and oximetry
in whole blood. The ABL90 FLEX PLUS analyzer is intended for use by trained technolo-
gists, nurses, physicians and therapists. It is intended for use in a laboratory environ-
ment, near patient or point-of-care setting.

The ABL90 FLEX PLUS analyzer can be connected to the RADIANCE system. The RADI-
ANCE system enables communication between the RADIANCE server and the ABL90
FLEX PLUS analyzer to allow remote data entry and analyzer access.

These tests are only performed under a physician's order. In the table below the meas-
ured parameters are shown:

Parameter group Parameter

pH/blood gas: pH (acidity)

pCO2 (carbon dioxide tension)

pO2 (oxygen tension)

Oximetry: ctHb (total hemoglobin concentration)

sO2 (oxygen saturation)

FO2Hb (fraction of oxyhemoglobin in total hemoglobin)

FCOHb (fraction of carboxyhemoglobin in total hemoglobin)

FHHb (fraction of deoxyhemoglobin in total hemoglobin)

FMetHb (fraction of methemoglobin in total hemoglobin)

FHbF (fraction of fetal hemoglobin)

ctBil (concentration of total bilirubin in plasma)

Electrolytes: cK+ (potassium ion concentration)

cNa+ (sodium ion concentration)

cCa2+ (calcium ion concentration)

cCl- (chloride ion concentration)

Metabolites: cGlu (D-glucose concentration)

cLac (L(+)-lactate concentration)

cCrea (Creatinine Concentration)*

cUrea/BUN (Urea/BUN concentration)*

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* Parameters only available on analyzers configured to feature creatinine and

urea/BUN.

Limitations of use

About limitations of use

WARNING – Risk of making incorrect clinical decisions

A clinician must always interpret patient test results in the relevant clinical context.

NOTE: Only analyze heparinized and electrolyte-balanced human whole blood samples
or dedicated quality control material. If you analyze other sample types, you risk
damage to the analyzer and incorrect results on subsequent samples.

No tests on animal blood have been done. Animal blood is different from human blood
and the composition of the blood can be different within the same species.
Related information
Interference tests, page 256

Measurement of FHbF

The uncertainty in FHbF measurements exceeds the level that is necessary to measure
normal HbF levels in the adult reference range (0-1 %). The analyzer can measure
FHbF hemoglobin in all types of sample, but the analyzer must be set up to apply an
HbF correction to the results.
Related information
To enable HbF corrections, page 170

Operator training requirements

Operators must have received hands-on training in the procedures and functions that
are relevant for their field of work and that are described in this Instructions for use.
Operators must have been trained in the procedures and functions until they can do
them successfully.

WARNING – Risk of incorrect medical treatment

Failure to select the correct measurement mode can cause incorrect results and incor-
rect medical treatment. Operators must be trained to do the patient sample analysis
correctly.

WARNING – Risk of delayed medical treatment

Failure to analyze patient samples correctly may require a new sample to be analyzed,
which can delay medical treatment. Operators must be trained to do the patient
sample analysis correctly.

WARNING – Risk of infection

Failure to analyze patient samples correctly can expose operators to potentially infec-
tious blood. Operators must be trained to do the patient sample analysis correctly.

About this document

This document tells you what the analyzer can do and how to use it. The analyzer has
a default set up that can be customized. Some topics in this document may therefore
not be relevant to your analyzer.

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Documentation

NOTE: The documents in the table give instructions for the safe and proper operation
of the analyzer. Radiometer does not accept warranty claims or product liability if oper-
ators do not follow these instructions.

Document Description

Instructions for use How to install and set up the analyzer, instructions for daily use and refer-
ence information

Inserts Instructions and information about consumables supplied for use with the
analyzer

About hazards

A hazard symbol shows which instructions an operator must obey to prevent risk to
persons or equipment. There are 2 types of hazard.

Hazard type Hazard Risk

symbol

WARNING Death or injury to persons

CAUTION Equipment damage or monitoring disruption

General warning and cautions

WARNING – Risk of infection

Only let authorized personnel collect and work with blood samples. Make sure to wear
gloves.
WARNING – Risk of electric shock
Make sure the analyzer is a minimum of 1.5 m from patient beds.
WARNING – Risk of infection
Dispose and handle all used sampling devices, quality control (QC) ampoules, Solution
Packs, Sensor Cassettes, Inlet Probes, Inlet Gasket Holders, Inlet Connector Gaskets
and Inlet Modules as biohazardous waste [1]. Follow your local regulations.

Reference

1. Clinical laboratory waste management. CLSI/NCCLS document GP5-A2, Clinical

Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Penn-
sylvania 19087-1898 USA.

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4 996-686C
Getting to know the analyzer 2
Overview of the analyzer

Front view

3
4

5
6

1 Touch screen 5 Compartment for the Sensor

Cassette

2 Barcode reader 6 Inlet gasket (for sample aspiration)

3 Sample mixer (for safePICO 7 Solution Pack

samplers)

4 Inlet Gasket Holder 8 Battery indicator light

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analyzer

Side and back view

The analyzer exists with two different port layouts.

Layout 1

1
3
2 7
4 8
5 9
10
6
11

12
13
14
15
16

1 Handle 9 Network cable port

2 Thermal printer 10 USB ports

3 USB port 11 Ventilator grid

4 Mouse port 12 Latch for manual release of a Solu-

tion Pack

5 Standby button 13 Power switch ON (|) and OFF (O)

6 External keyboard port 14 Mains power fuse

7 External monitor port 15 Mains power socket

8 COM port 16 Serial number

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Layout 2

1 3
2 7
4
5 8
9
6
10

11
12
13
14
15

1 Handle 9 USB port

2 Thermal printer 10 Ventilator grid

3 USB port 11 Latch for manual release of a Solu-

tion Pack

4 COM port 12 Power switch ON (|) and OFF (O)

5 Standby button 13 Mains power fuse

6 HDMI port 14 Mains power socket

7 USB ports 15 Serial number

8 Network cable port

Consumables

Consumables are parts of the analyzer. The consumables have to be replaced at

different times. With the exception of the printer paper, the analyzer tells you when
consumables must be replaced.

Consumables Description

Sensor Cassette Contains sensors for the tests (except for the oximetry and
bilirubin tests)

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Consumables Description

Solution Pack Contains pouches with QC and calibration material, rinse solu-
tion, a gas mixture and closed containers to hold liquid and clot
waste

Inlet Gasket Holder Holds the inlet gasket (1). This is where you put your sampling
device for sample aspiration.
1

Printer paper Paper for the thermal printer

To see details about installed consumables

1. Tap Menu > Analyzer status > Consumables.
An overview is shown.
2. Choose an option and follow the steps for it.
Option Steps

To see more data about the Solution Pack Tap Status > Solution Pack

To see more data about the Sensor Cassette Tap Status > Sensor Cassette

Is the analyzer ready for use?

Three important conditions

The analyzer is ready for use when three conditions are present.

1. Make sure that the analyzer is Ready.

2. The color of the tab of the parameters you want to get a result for is green or
yellow.
3. The color of the traffic light in the Analyzer status button is green or yellow.

Parameter tab colors

Parameter Indication
tab color

Green You will get a result for the parameter

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analyzer

Parameter Indication
tab color

Yellow with one A QC or calibration error was found for the parameter, but you will get a result
line crossing

Red with two No result will be reported for the parameter.

lines crossing
The conditions that may cause a parameter tab to be red are shown below.
• An operator has locked the parameter in the Parameter setup screen
• An operator has locked the analyzer (all parameter tabs will change to red)
• Parameter repression was enabled for the parameter and a QC and/or cali-
bration error is present
• Ampoule-based QC measurements are pending. The analyzer was set up to
lock after a Solution Pack and/or Sensor Cassette replacement until the QC
measurements are completed.

To access the Analyzer status screen

1. Tap Menu > Analyzer status or, if available on the screen, just the Analyzer
status button.

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analyzer

The Analyzer status screen

1 Analyzer status button – the 4 Sensor Cassette icon – the number

color of the traffic light on the adjacent to the icon shows the
button shows the overall status of number of tests that are left.
the analyzer.

2 Recommended action – if there 5 Solution Pack icon – the number

are any recommended actions, adjacent to the icon shows the
they are shown here when the number of activities that are left.
Analyzer status screen is opened.

3 Five buttons – the color of the 6 Start button – the button gives
traffic lights adjacent to each you quick access to the start
button shows the overall status of screen. The start screen is where
various activities within the most measurements can be
analyzer. The buttons give access started.
to details and activities.

Analyzer status - Traffic light colors

Traffic light Indication Consequences

color

Green No condition exists that requires action. All operations are possible

Yellow One or more messages indicate a condition All operations are possible
that requires action, but not immediate
action.

Red One or more messages indicate a condition Only actions that are necessary
that requires immediate action. to remove the reported condi-
tions can be done.

Messages

The analyzer shows different types of message.

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analyzer

Message type Where messages are shown

Status In the Analyzer status screens

Feedback In the space above the parameter bar.

NOTE: Feedback messages tell operators something about an action that they
have just done or about measurements and calibrations in progress. Feedback
messages are shown for a short period of time.

Pop-up In pop-up windows

Result In result message screens

Activity In the Activity log screen

To find and troubleshoot messages in the Analyzer status screen

Prerequisite(s)
• The traffic light in the Analyzer status button is yellow or red

1. Tap Menu > Analyzer status.

2. Tap the button adjacent to a yellow or red traffic light.

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analyzer

3. Choose an option and follow the steps for it.

Option Steps

To troubleshoot a Follow the instructions on the screen

Recommended
action

To troubleshoot To troubleshoot errors in the Built-in QC and

Quality control Ampoule-based QC fields:
messages a) Select the quality control measurement marked by a ,

or symbol.
b) Tap the Result button.
c) Tap the Messages button.
d) Select the message.
e) Tap the Troubleshoot button.
f) Follow the instructions on the screen.
To troubleshoot messages in the QC Messages field:
a) Select the message.
b) Tap the Troubleshoot button.
c) Follow the instructions on the screen.

To troubleshoot To troubleshoot calibrations marked by a , or

Calibrations
symbol.
messages
a) Select the marked calibration.
b) Tap the Result button.
c) Tap the Messages button.
d) Select the message.
e) Tap the Troubleshoot button.
f) Follow the instructions on the screen.
To troubleshoot messages in the Message field:
a) Select the message.
b) Tap the Troubleshoot button.
c) Follow the instructions on the screen.

To troubleshoot a) Select the message.

Consumables or b) Tap the Troubleshoot button.
System
messages c) Follow the instructions on the screen.

Related information
About guided troubleshooting, page 91

Is the analyzer operating on battery power?

If a battery is installed in the analyzer, the battery indicator light will be on and a
symbol in the lower right corner of the screen shows which power supply is in use.

NOTE: The analyzer can operate on battery power for a limited period of time. The age
and charge level of the battery and the number of activities that are done limit this
period.

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analyzer

Symbol Battery indicator Indication

Yellow light that Only battery power is in use

blinks slowly

Yellow light that Only battery power is in use.

blinks fast
The analyzer must be connected to the mains power supply to
prevent analyzer shutdown.

NOTE: The color of the battery in the symbol changes to red

when the level falls below 14 %. The analyzer shuts down when
the level falls below 11 %.

Green light Only the mains power supply is in use

Green light that Only the mains power supply is in use. It supplies power to the
blinks slowly analyzer and recharges the battery at the same time.

NOTE: The number indicates the charge level of the battery.

Common tasks

To log on

Dependent on how your analyzer is set up, you may have to log on to the analyzer to
get access to menus or buttons.

If it is necessary to log on to the analyzer, this is how to do it.

NOTE: It is not necessary to log on to an analyzer that is set up for anonymous use.

1. Tap Menu > Log on.

2. Enter or scan data into the fields.
NOTE: If that is not possible, tap the Extended logon or the Logon BC button
and enter or scan data into the fields.

To get quick access to the start screen

1. Tap the Start button in the top right corner of the screen.

To scan a barcode
1. Hold the barcode parallel to the barcode reader and no more than 7 cm from it.
NOTE: Radiometer recommends using barcodes with a check digit to avoid the risk
of misreading.

To enter text
1. Tap where you want to enter text.

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analyzer

2. Choose an option and follow the steps for it.

Option Steps

To use the keyboard on the screen a) Tap the button.

b) Enter the text.
c) Tap the button.

To use an external keyboard a) Enter the text.

b) Press the Enter key.

To select/deselect a check button

1. Choose an option and follow the steps for it.
Option Steps

To select a check button Tap the check button.

To deselect a check button Tap the check button.

To save changes
1. Choose an option and follow the steps for it.
Option Steps

To save changes and go to the previous Tap the Back button.

screen

To save changes and close the screen Tap the Close button.

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analyzer

Menu

Menu structure

Menu

Log off
Calibration programs Calibration
tHb calibration

Start programs Rinse

Liquid sensor adjust
Pump calibration
Auxiliary programs
Tubing refill
Manual flush
Automatic flush

Setup (See Related information)

WDC report
Backup all data
Restore all data
Export data logs
Disk functions
Import / Export archives
Save setup
Utilities
Load setup
Sample counter Restore default setup
Temporary shutdown
Long term shutdown
RADIANCE browser
Service

Patient results log

Patient profiles log
Quality control log
Data logs Calibration log
Activity log
Replacement log
Patient results archive
Quality control archive
Archived data logs Calibration archive
Analyzer status
Activity archive

My results

Latest result

Related information
Setup menu structure, page 143

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analyzer

Data logs

About data logs

Data logs are where patient data and results of measurements and activities are saved.

Overview of data logs

Data logs Content

Patient results log • Results of patient sample analyses

• Results of calibration verification measurements

Patient profiles log Data that helps to identify patients whose blood has been analyzed

Calibration log Results of calibrations

Quality control log Results of QC measurements

Activity log Activities done on or by the analyzer

Replacement log Record of replacement activities

Archived data logs The oldest results/activities from the data logs.

NOTE: Automatic archiving must be set up.

To access data logs

1. Tap Menu > Data logs.
2. Tap the data log you want.

16 996-686C
Patient sample analysis 3
General warnings and cautions

WARNING – Risk of infection

Only let authorized personnel collect and work with blood samples. Make sure to wear
gloves.

WARNING – Risk of infection

Dispose and handle all used sampling devices, quality control (QC) ampoules, Solution
Packs, Sensor Cassettes, Inlet Probes, Inlet Gasket Holders, Inlet Connector Gaskets
and Inlet Modules as biohazardous waste [1]. Follow your local regulations.

WARNING – Risk of infection

Make sure you do not prick or scratch yourself on the Inlet Probe.

Anticoagulants

Most Radiometer sampling devices contain dry, electrolyte-balanced heparin. In

general, this type of heparin gives good results, because it minimizes the bias on cNa+,
cK+ and cCa2+ results.

Different types of anticoagulant may change the concentration of some parameters and
give false patient results.

Anticoagulant Possible effect on patient results

Heparin in liquid form Biased results on all parameters

Anticoagulants with sodium cations Falsely high cNa+ results

(Na+)

Anticoagulants with sodium and potas- False cNa+, cK+ results

sium cations (Na+ and K+)

Anticoagulants with Lithium/Zinc False cCa2+ results

heparin

Anticoagulants with ammonium heparin False cCl– and cUrea/BUN* results

Disodium oxalate with sodium fluoride Falsely high cNa+, falsely low cCa2+ and false cGlu
and cLac results

Trisodium citrate False cNa+, cK+, cCa2+, pH, cGlu, and cLac results

EDTA • False pH, pCO2, cNa+, cK+ and cCa2+ results

• False cCa2+, cCrea* and cUrea/BUN* results in
subsequent patient samples

* Parameters only available on analyzers configured to feature creatinine and

urea/BUN.

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WARNING – Risk of incorrect results

Do not use EDTA as an anticoagulant, as it will cause incorrect pH, pCO 2, cNa+, cK+,
cCa2+, cCrea and cUrea/BUN results and have an effect on subsequent cCa2+ measure-
ments.

CAUTION – Risk of equipment damage

Do not use EDTA as anticoagulant as it will decrease the lifetime of the calcium sensor.

Good results come from good samples

What is a good sample?

Characteristics of a good Why are the characteristics important?

sample (in sequential order)

A recommended sampler is used To prevent incorrect results

The sample is clearly and uniquely To prevent a patient-sample mix-up

identified

The sample is collected from a To prevent incorrect results

suitable site

A sufficient sample volume is If there is no sufficient sample volume, the sample is lost
collected

Air bubbles are removed immedi- To prevent incorrect results

ately after collection

The sample is gently mixed imme- To prevent clots in the sample.

diately after air bubbles have been
removed If there are clots in the sample, it cannot be analyzed by
the analyzer.

The sample is not shaken To prevent hemolysis of the sample.

Hemolysis can cause bias on electrolytes, especially cK+,

and cUrea/BUN.

The sample is gently mixed again To have a homogeneous sample for the patient sample
just before it is analyzed analysis.

Inhomogeneous samples may cause incorrect results.

The sample is analyzed immedi- To prevent that the sample gets too old.
ately after mixing
NOTE: For the best results, good samples must be
analyzed immediately. When this is not possible, samples
must be stored correctly, gently mixed immediately before
analysis and analyzed within the time period given in the
storage recommendations.

NOTE: The list includes most, but not all the characteristics of a good sample.

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To get a good sample

Prerequisite(s)
• A recommended sampler is used

Good results come from good samples [2,3,4]. Here are five points to remember.

1. Label the sample.

Use more than one patient identifier. For example, patient ID and sampler ID.
2. Collect the sample from a suitable site.
3. WARNING – Risk of incorrect results
Remove any air bubbles to prevent incorrect results.
4. WARNING – Risk of incorrect results
Gently mix the sample immediately after air bubbles have been removed to
prevent clots.
To mix the sample, follow your local standard operating procedure and the instruc-
tions for use for the sampling device.
5. Analyze the sample immediately after mixing.
NOTE: When this is not possible, store the sample correctly, gently mix it just
before analysis and analyze it within the time period given in the storage recom-
mendations.

To mix a sample on the analyzer

Required item(s)

A safePICO with safeTIPCAP

NOTE: If the sample is in a safePICO syringe with a safeTIPCAP cap, do not remove
the safeTIPCAP cap.

1. Put the syringe in the sample mixer.

2. Wait until the light starts blinking.
3. Remove the syringe.

Storage recommendations

These types of blood samples must be analyzed immediately after they are collected
[5,6]:

• Samples with increased leukocyte or platelet counts

• Samples with an atypical metabolism
• Fetal scalp samples
• Fast-clotting samples
• Samples with high pO2 values should be analyzed within 5 minutes after they are
collected [7].
WARNING – Risk of biased results especially pO2 results
Interpret with caution the results for samples in capillary tubes as the aerobic
sampling technique may cause bias.

Samples that cannot be analyzed immediately after they are collected must be handled
and stored correctly before they are analyzed [3,8]. The table provides an overview.

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Sampling Type Handling and storage temperatures Analyze within

device this time
period

Syringe Plastic Keep at room temperature <30 minutes

[2,9,10,11,12,13]

Syringe Glass Keep at room temperature [2,3] <30 minutes

Keep in water at 0-4 °C. <60 minutes

NOTE: Do not keep the sample on ice as it can

cause hemolysis** [7,11,12,13].

Capillary tube Plastic* Keep at room temperature <10 minutes

Capillary tube Glass Keep at room temperature <10 minutes

Keep the sample horizontal at 0-4 °C. <30 minutes

NOTE: Do not keep the sample on ice as it can

cause hemolysis** [7,11,12,13].

* Samples in safeCLINITUBES capillary tubes deteriorates with increased storage time

(greater variability of gasses and of tHb measurements).

** Hemolysis can cause bias on electrolytes, especially cK+ and urea/BUN.

Pre-registration of samples

About sample pre-registration

Sample pre-registration lets operators make sure that the patient data shown on the
screen belongs to the patient whose sample is to be analyzed. This reduces the risk of
patient/sample mix-up.

NOTE: The analyzer must be set up for sample pre-registration.

Related information
To set up sample pre-registration, page 161

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To pre-register a sample

Required item(s)

A barcode
(patient or sample)

Prerequisite(s)

NOTE: Radiometer recommends using barcodes with a check digit to avoid the risk of
misreading.
• The analyzer is set up for sample pre-registration
• A barcode that identifies the patient and/or the blood sample is available

1. Scan the barcode.

2. Make sure the data that is shown on the screen belongs to the patient whose
sample you want to analyze.
Option Steps

If the data is correct a) Analyze the sample.

If the data is not correct a) Tap the Cancel button.

Related information
To analyze a sample from a syringe, page 22
To analyze a sample from a capillary tube, page 23
To analyze a sample from a test tube, page 25

Analyzing patient samples

General information for obtaining successful patient sample analyses

The analyzer will guide you through the different steps of the patient sample analysis
process. Depending on the setup, the process will vary. Always look at the screen and
follow the instructions on the screen.

Depending on the setup:

• You may be able to select measurement mode during sample analysis. If so, you
must select a measurement mode, or the analyzer will automatically select the
measurement mode set up as default in the setup.
• In the Patient identification screen, it is mandatory to enter data in fields with
this icon:

The sample will be analyzed, but the results will not be available until data is
entered.
• In the Patient identification screen, it is possible to change the report layout
during sample analysis.

During patient sample analysis, make sure that the Inlet Probe does not touch the
plunger of or the fiber disk in the syringe as this may cause the sample to be aspirated
incorrectly.

If there is <1.1 mL in a PICO50 sampler or <0.7 mL in a PICO70/safePICO70 sampler,

you must be careful with this.

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If you have very little sample dead space, consider to use the short probe measure-
ment mode.

In order not to bend the Inlet Probe, hold the sampling device still during sample anal-
ysis. If the Inlet Probe is bent, do not use the analyzer for sample analysis.

To analyze a sample from a syringe

Prerequisite(s)
• A good sample (no air bubbles, no exposure to air, and no clots) is available
• Make sure that the analyzer is Ready
NOTE: If the sample is in a safePICO syringe with a safeTIPCAP cap, do not remove
the safeTIPCAP cap during sample analysis.

NOTE: Once the inlet is opened, you only have a short time to complete the actions
necessary.

1. WARNING – Risk of incorrect results

Gently mix the sample to make sure that it is homogeneous.
2. Hold the syringe by its barrel.
3. Tap the Syringe button.
The analyzer opens the inlet.
4. If measurement mode can be selected, select measurement mode.
NOTE: If you selected the wrong mode, tap the Reselect button and select the
correct mode.
NOTE: If the Other modes button is available, tap it to get access to more
modes.
5. Follow the instructions on the screen.
6. Place and hold the tip of the syringe in the center of the Inlet Gasket.
7. WARNING – Risk of incorrect tHb results
Push the syringe into the analyzer as far as it will go and hold it there.

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8. Hold the syringe in the pushed-in position until the analyzer tells you to remove it.

9. When the analyzer tells you to, remove the syringe.

The analyzer closes the inlet.
10. If necessary, select a different report layout as follows:
a) Tap the current Report layout shown on the screen.
b) Select a new layout from the list.
c) Tap the Select button.
11. Enter the necessary data in the Patient identification screen.
NOTE: It is mandatory to enter data in fields with this icon:
12. If the Patient result screen opens before you have entered the necessary data,
tap the ID button.

Related information
To pre-register a sample, page 21
To get a good sample, page 19

To analyze a sample from a capillary tube

Required item(s)

A Clot Catcher

Prerequisite(s)
• A good sample (no air bubbles, no exposure to air, and no clots) is available
• Make sure that the analyzer is Ready

To prevent clots, it is recommended that you use an ABL90 FLEX PLUS Clot Catcher.

NOTE: Once the inlet is opened, you only have a short time to complete the actions
necessary.

1. WARNING – Risk of incorrect results

Gently mix the sample to make sure that it is homogeneous.
2. Move the mixing wire to the end opposite to that from which the sample is to be
aspirated.
NOTE: If petroleum jelly, such as Vaseline, is used at the puncture area, introduce
the capillary sample into the analyzer from the end without petroleum jelly.
3. Remove the end caps of the capillary tube.
4. Put the Clot Catcher on the end opposite to that with the mixing wire.
5. Hold the capillary tube and tap the Capillary button.
The analyzer opens the inlet.

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6. If measurement mode can be selected, select measurement mode.

NOTE: If you selected the wrong mode, tap the Reselect button and select the
correct mode.
NOTE: If the Other modes button is available, tap it to get access to more
modes.
7. Follow the instructions on the screen.
8. Place and hold the end with the Clot Catcher in the center of the Inlet Gasket.
NOTE: If you turn the capillary tube slightly when you place it in the center, it may
be easier to put it in the right place.
9. Carefully push the capillary tube into the analyzer as far as it will go and hold it
there.

10. Hold the capillary tube in the pushed-in position until the analyzer tells you to
remove it.

11. When the analyzer tells you to, remove the capillary tube.
The analyzer closes the inlet.
12. If necessary, select a different report layout as follows:
a) Tap the current Report layout shown on the screen.
b) Select a new layout from the list.
c) Tap the Select button.
13. Enter the necessary data in the Patient identification screen.
NOTE: It is mandatory to enter data in fields with this icon:
14. If the Patient result screen opens before you have entered the necessary data,
tap the ID button.

Related information
To pre-register a sample, page 21
To get a good sample, page 19

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To analyze a sample from a test tube

Prerequisite(s)
• A good sample (no air bubbles, no exposure to air, and no clots) is available
• Make sure that the analyzer is Ready

NOTE: Once the inlet is opened, you only have a short time to complete the actions
necessary.

1. WARNING – Risk of incorrect results

Gently mix the sample to make sure that it is homogeneous.
2. Uncap the test tube.
3. Hold the test tube and tap the Syringe button.
The analyzer opens the inlet.
4. If measurement mode can be selected, select measurement mode.
NOTE: If you selected the wrong mode, tap the Reselect button and select the
correct mode.
NOTE: If the Other modes button is available, tap it to get access to more
modes.
5. Follow the instructions on the screen.
6. Place and hold the lip of the test tube against the collar of the Inlet Gasket.
7. Push the test tube into the analyzer as far as it will go and hold it there.

NOTE: Make sure that the probe extends into the sample and stays there during
sample aspiration.
8. Hold the test tube in the pushed-in position until the analyzer tells you to remove
it.

9. When the analyzer tells you to, remove the test tube.
The analyzer closes the inlet.

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10. If necessary, select a different report layout as follows:

a) Tap the current Report layout shown on the screen.
b) Select a new layout from the list.
c) Tap the Select button.
11. Enter the necessary data in the Patient identification screen.
NOTE: It is mandatory to enter data in fields with this icon:
12. If the Patient result screen opens before you have entered the necessary data,
tap the ID button.

Related information
To pre-register a sample, page 21
To get a good sample, page 19

̄
To get calculated values for FShunt and ctO2(a-v)

Prerequisite(s)
• A patient report layout for FShunt and ctO2(a-v̄) has been created
• A mixed-venous blood sample and an arterial blood sample, collected directly after
each other from the patient

1. Analyze the mixed-venous blood sample. Use the report layout created for FShunt
and ctO2(a-v̄).
2. Enter data in the Patient identification screen.
NOTE: If the Patient identification screen closes before you have entered the
necessary data, tap the ID button to get back to the Patient identification
screen.
3. Note the values for these parameters. You need them for steps 6 to 9 inclusive:
• pO2(v̄)
• sO2(v)̄
• FO2(I)
• RQ
• T
4. Analyze the arterial sample. Use the report layout created for FShunt and
ctO2(a-v̄).
5. Select “Arterial” for Sample type.
6. Enter the values for pO2(v̄) and sO2(v)̄ that were noted in step 3.
7. If the FO2(I) value is not equal to the default value of 0.21, enter the value you
noted in step 3.
8. If the RQ value is not equal to the default value of 0.86, enter the value you noted
in step 3.
9. If the T value is not equal to the default value of 37 °C, enter the value you noted
in step 3.
10. Enter other data in the Patient identification screen.
NOTE: If the Patient identification screen closes before you have entered the
necessary data, tap the ID button to get back to the Patient identification
screen.

NOTE: If no value is entered for pO2(v)̄ , sO2(v̄), FO2(I), RQ or T, the FShunt value
will be estimated.
NOTE: If no value is entered for pO2(v)̄ and sO2(v̄), a default value will be used
for ctO2(a-v̄).

Related information
To create a patient report layout, page 163

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Entering and editing data in the Patient identification

screen

The Patient identification screen

The content of the Patient identification screen shown below shows the items
included in the -R- Default report layout. Other layouts can be created.

To change the report layout in the Patient identification screen

When you change the report layout, data fields in the Patient identificatlon screen
can change.

1. Tap the current Report layout.

2. Select a new layout.
3. Tap the Select button.

To request patient data automatically when connected to a LIS/HIS

system

Prerequisite(s)
• The analyzer is connected to a LIS/HIS/data management system
• The analyzer is set up to enable automatic requests for patient data

1. In the Patient identification screen, enter data in the field that was set up to
enable data to be requested automatically.
NOTE: It will be one of these fields: Accession number or Patient ID or
Sampler ID.
NOTE: If no data is transmitted, tap the Request button.

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To request patient data using Patient lookup

Prerequisite(s)
• The Patient report includes the Department (Pat.) field
• The analyzer is set up to enable patient lookup

1. In the Patient identification screen, enter data in the Department (Pat.) field.
2. Tap the Patient lookup button.
3. Select the patient from the list.
4. Tap the Select button.
Based on the Patient ID of the patient you selected, data is requested and down-
loaded to the Patient identification screen.

To edit data in the Patient identification screen

1. Find the patient result.
2. Tap the ID button.
3. Edit the necessary data.

Patient results

To find a patient result

1. Choose an option and follow the steps for it.
Option Steps

To find a result in the data a) Tap Menu > Data logs > Patient results
log log.
b) Select the measurement.
c) Tap the Result button.

To find a number of results in a) Filter the data from the Patient results log
the data log

To find the latest result a) Tap Menu > Latest result.

To find a result under My a) Tap Menu > My results.

results b) Select the measurement.
c) Tap the Result button.

Symbols on patient results

WARNING – Risk of making incorrect clinical decisions

A clinician must always interpret patient test results in the relevant clinical context.

Problems on patient results are marked with one or more of the symbols shown in the
table.

Symbol Description

An error occurred. A message attached to the result describes the error.

Result is above the reference range but below the upper critical limit

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Symbol Description

Result is below the reference range but above the lower critical limit

Result is above the upper critical limit but below the upper limit of the reportable
range

Result is below the lower critical limit but above the lower limit of the reportable
range

No result is shown because it is above the upper limit of the reportable range.

NOTE: The analyzer can be set up to show the result as greater than the value of
the upper limit of the reportable range. For example: All pH results above 7.850
(the upper limit of a pH reportable range) will be shown as >7.850.

No result is shown because it is below the lower limit of the reportable range.

NOTE: The analyzer can be set up to show the result as less than the value of the
lower limit of the reportable range. For example, all pH results below 6.750 (the
lower limit of the pH reportable range) will be shown as <6.750.

..... No result could be calculated or value outside range of indication

(blank) No result shown because it is outside the reportable range

* User-defined correction factors were used to calculate the result

c A subscript of the letter c shows that the value was calculated from measured
and/or keyed-in (input) values. Only shown on derived parameters.

e A subscript of the letter e shows that the value was estimated. Default values
were used to replace measured and/or keyed-in (input) values that were not
available. Only shown on derived parameters.

About ranges and critical limits

Measurement results are marked by symbols to show where they fall in relation to
reference ranges, critical limits and reportable ranges. The diagram illustrates these
relationships.

1 Reference range 4 Reportable range

2 Lower critical limit 5 Range of indication

3 Upper critical limit

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Status in the Patient results log

The Status column in the Patient results log screen shows the overall status of each
patient sample analysis.

Symbol Description

OK The sample analysis was successful

? An error was found on one or more parameter result.

Aborted The sample analysis was stopped by the analyzer because it found an error

To see messages on patient results

Prerequisite(s)
• There are messages on the patient result

1. Tap Menu > Data logs > Patient results log.

2. Select the measurement.
3. Tap the Result button.
4. Tap the Messages button or tap the Log > Messages buttons.

To troubleshoot messages on results

Prerequisite(s)
• You can see the message you want to troubleshoot

1. Select the message.

2. Tap the Troubleshoot button.
3. Follow the instructions on the screen.

To see the acid-base chart for a result

Prerequisite(s)
• The sample type must be specified as “Arterial” and the results must include pH and
pCO2 values

1. Tap Menu > Data logs > Patient results log.

2. Select the measurement.
3. Tap the Result button.
4. Tap the acid-base chart button.

NOTE: The chart must only be used as a guideline.

Reviewing and editing patient results

To filter data from the Patient results log

1. Tap Menu > Data logs > Patient results log.
2. Tap the Filter button.

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3. In the Criteria frame, choose an option and follow the steps for it.
Option Steps

To select a time period prior to Tap the number button for the number of
today's date days you want

To select a start and end date Enter data in the Start date: and End date:
fields
4. Select the next criterion. If necessary, enter or select a value for it.
5. If more criteria are necessary, tap the More button.
6. If necessary, do step 4 again.
7. Tap the Apply button.

To see trends in a patient's results

Prerequisite(s)
• You have filtered the patient's results from the Patient results log

1. Tap the Trend button.

2. Select the parameters.
3. Tap the View trend button.

To see the audit trail on a patient result

Prerequisite(s)
• Changes were made to the patient result

An audit trail shows the changes made to a patient result.

1. Tap Menu > Data logs > Patient results log.

2. Select the measurement.
3. Tap the Result button.
4. Tap the Log > Audit trail buttons.
NOTE: The Log button will only be available if changes were made to the patient
result.

To add a note to a patient result

1. Tap Menu > Data logs > Patient results log.
2. Select the measurement.
3. Tap the Result button.
4. Tap the Messages button.
5. Tap the Note button.
6. Choose an option and follow the steps for it.
Option Steps

If a pop-up window is shown To use one of the listed notes:

• Select the note
• Tap the Enter button
To enter a new note:
• Tap the Edit Note button.
• Enter the note.

If no pop-up window is shown Enter a note.

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7. Tap the Back > Close buttons.

To remove a parameter from a patient result

Prerequisite(s)
• The result is not approved or rejected

1. Tap Menu > Data logs > Patient results log.

2. Select the measurement.
3. Tap the Result > ID > Parameters buttons.
4. Deselect the check buttons for the parameter you want to remove.
5. Tap the Back > Back > Close buttons.
NOTE: The result of the parameter is removed from the Patient results screen
and from printed results.

To show a parameter in a patient result

Prerequisite(s)
• The parameter was removed from the patient result
• The patient result is not approved or rejected

This procedure allows you to see the parameter on the screen and in printed results.

1. Tap Menu > Data logs > Patient results log.

2. Select the measurement.
3. Tap the Result > ID > Parameters buttons.
4. Select the check button for the parameter you want to see.
5. Tap the Back > Back > Close buttons.

Approval and rejection of patient results

Approval/rejection of patient results is not set up by default. If it is set up, it can be

used to filter patient results that are transmitted to a LIS/HIS system. Approved
results are transmitted, rejected results are not.

NOTE: An approved patient result does not indicate that the result can be used in a
clinical evaluation of the patient.

Approval can for example be used to make sure that necessary data was correctly
entered, for example, that the Sample type was “Venous”, not “Arterial” and the
patient temperature was 42 °C, not 38 °C.

NOTE: Approved/rejected results can only be edited by operators with approval rights.

To approve a patient result

1. Tap Menu > Data logs > Patient results log.
2. Select the measurement.
3. Tap the Result button.
4. Tap the Approval > Approve buttons.
5. Tap the Accept button.
6. Tap the Back > Close buttons.

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To reject a patient result

1. Tap Menu > Data logs > Patient results log.
2. Select the measurement.
3. Tap the Result button.
4. Tap the Approval > Reject buttons.
5. Tap the Accept button.
6. Tap the Back > Close buttons.

Critical limit notification

About Critical limit notification

In some countries physicians must be notified when a patient result lies outside the
critical limit.

When Critical limit notification is enabled, a notification procedure is necessary

before results with values outside the critical limit can be transmitted to external
systems and printed automatically. The results are pending until a notification proce-
dure is done. The results can be seen in Pending results log.

To enable Critical limit notification

1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. Tap Enable critical limit notification.
3. Tap the Check button.
4. Tap the Close button.
NOTE: If a print of the result is needed, you can make a print from the Notifica-
tion screen. The printout will tell you that the notification is pending.

To use Critical limit notification

1. Choose an option and follow the steps.
Option Steps

If a pop-up window notifies you a) Go to step 2.

that the result has values that lie
outside critical limits.

If an exclamation mark is shown a) Tap Data logs > Pending results log.
on the Data logs button. b) Highlight a result.
c) Tap the Result button.
NOTE: A pop-up window notifies you that the
result has values that lie outside critical limits.

2. Tap inside the message to close the pop-up window.

3. Tap Notification.
4. See the values that are outside critical limits.
NOTE: If it is not necessary to notify about the values, tap Not needed and go to
step 6.
5. Call the physician or person responsible for the treatment and notify them about
the values.
6. Fill in the data fields on the screen.
7. Tap the Accept button.

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Pending results log

The Pending results log contains the following results:

• Results that someone needs to be notified about
• Results that need to be approved
• Results that need mandatory input

Results in the Pending results log are filtered from the Patient results log and
remain pending until they have been dealt with. If results are pending, an exclamation
mark is shown on the Data logs button.

To access the Pending results log

1. Tap Data logs > Pending results log.

Input fields for the Patient report layout

The following notification-related input fields can be added to the patient report layout:
• Notified whom
• Notified time
• Notified by
• Notification status
• Notification

NOTE: To include these items in a patient report layout, see Entering and editing data
in the Patient identification screen.

References

1. Clinical laboratory waste management. CLSI/NCCLS document GP5-A2, Clinical

Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Penn-
sylvania 19087-1898 USA.
2. CLSI. Procedures for the collection of arterial blood specimens; approved
standard - Fourth Edition. CLSI/NCCLS document H11-A4, Clinical Laboratory
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898 USA, 2004.
3. CLSI. Blood gas preanalytical considerations: specimen collection, calibration and
controls; Approved guideline. CLSI/NCCLS document C27-A, Clinical Laboratory
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087- 1898 USA, 1993.
4. CLSI. Procedures and devices for the collection of diagnostic capillary blood speci-
mens; approved standard - Fifth Edition. CLSI/NCCLS document H4-A5, Clinical
Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Penn-
sylvania 19087-1898 USA, 2004.
5. Woolley A, Hickling K. Errors in measuring blood gases in the intensive care unit:
Effect of delay in estimation. J Crit Care 2003; 18: 31-37. 12. Blonshine S. To ice
or not to ice. AARC Times 2000: 37-39.
6. Nickelsen CN. Fetal capillary blood pH. www.bloodgas.org, 2002.
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tions on whole blood sampling, transport and storage for simultaneous determina-
tion of pH, blood gases and electrolytes. Eur J Clin Chem Clin Biochem 1995; 33:
247-53.
8. Skurup A. Storage recommendations for blood gas samples. Radiometer Publica-
tion bulletin no. 31-2006. Copenhagen: Radiometer Medical A/S. Code no.
918-686.
9. Mahoney JJ, Van Kessel A. Arterial blood gas analysis. Respir Care 1997: 249-79.

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10. Smeenk F, Janssen J, Arends B, Harff G, Bosch J, Schönberger J, Postmus P.

Effects of four different methods of sampling arterial blood and storage time on
gas tensions and shunt calculation in the 100% oxygen test. Eur Respir J 1996;
10: 910-13.
11. Mahoney JJ, Harvey JA, Wong RJ, Kessel VLA. Changes in oxygen measurements
when whole blood is stored in iced plastic or glass syringes. Clin Chem 1991; 37:
1244-48.
12. Blonshine S. To ice or not to ice. AARC Times 2000: 37-39.
13. Liss P, Payne P. Stability of blood gases in ice and at room temperature. Chest
1993; 103: 1120-21.

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36 996-686C
Replacements and maintenance 4
General warnings and cautions

WARNING – Risk of infection

Only let authorized personnel collect and work with blood samples. Make sure to wear
gloves.

WARNING – Risk of infection

Dispose and handle all used sampling devices, quality control (QC) ampoules, Solution
Packs, Sensor Cassettes, Inlet Probes, Inlet Gasket Holders, Inlet Connector Gaskets
and Inlet Modules as biohazardous waste [1]. Follow your local regulations.

WARNING – Risk of infection

Make sure you do not prick or scratch yourself on the Inlet Probe.

WARNING – Risk of infection

Make sure that you wear gloves during replacement and maintenance procedures.

Types of consumables

Sensor Cassettes and Solution Packs are available in 2 types.

Measured parameters Sensor Cassette Solution Pack

pH, pCO2, pO2, tHb, sO2, Sensor Cassette - SC90 Solution Pack - SP90
O2Hb, COHb, MetHb, HbF,
HHb, K+, Na+, Ca2+, Cl-, cGlu,
cLac, tBil

pH, pCO2, pO2, tHb, sO2, Sensor Cassette - SC90 Ki Solution Pack - SP90 Ki
O2Hb, COHb, MetHb, HbF,
HHb, K+, Na+, Ca2+, Cl-, cGlu,
cLac, tBil, cUrea/BUN, cCrea

Solution Packs and Sensor Cassettes of the same type must be installed for the
analyzer to function. Consumable types are not interchangeable; a SC90 will func-
tion only with a SP90, and a SC90 will not function with a SP90 Ki.

Use SP90 Ki and SC90 Ki consumables when the analyzer is configured to feature crea-
tinine and urea/BUN.

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During a replacement the analyzer will request a specific consumable. Choose the
consumable based on the icon requested by the analyzer.

To order products for use with your analyzer

1. Find the code number for the product.
2. Contact your local Radiometer representative.

Related information
Solution Packs – code numbers, page 377
Sensor Cassettes – code numbers, page 377
Spare parts and accessories - code numbers, page 378
Quality control products – code numbers, page 378

Replacement intervals for consumables and Inlet Connector Gasket

The recommended replacement intervals shown in the table are only a guideline. They
are based on a default of 10 sample analyses per day. For analyzers with a higher
sample throughput, the number of Expected measurements per day can be
changed in the setup, so the analyzer can calculate the most probable replacement
date and send a message about it.

Consumables Default tests or Recommended replacement interval after

activities per day installation

Solution Pack SP90 10 Maximum 30 days or when the number of activi-

ties is zero

Solution Pack SP90 Ki 10 Maximum 14 days or when the number of activi-

ties is zero

Sensor Cassette SC90 10 Maximum 30 days or when the number of tests

is zero

Sensor Cassette SC90 Ki 10 Maximum 14 days or when the number of tests

is zero

Inlet Gasket Holder 10 12 months

Inlet Connector Gasket 10 12 months

NOTE: Samples containing extreme concentrations, as well as some auto-activities,

can consume more than 1 activity from the activity counter.

Related information
To set up replacement warnings, page 196

Replacements

Solution Pack

To see the Solution Pack status

1. Tap Menu > Analyzer status > Consumables.
2. For more information, tap the Status > Solution Pack buttons.

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To replace the Solution Pack

Required item(s)

A new Solution Pack - SP90 A new Solution Pack - SP90 Ki

1. Tap Menu > Analyzer status.

2. Tap the Consumables > Replace > Solution Pack buttons.
3. Tap the Press to start video guidance button.
The analyzer opens the inlet.
4. Check that you have the correct Solution Pack.
5. Wait until the Solution Pack is released.
6. Remove the Solution Pack and dispose of it as biohazardous waste.

7. Lift the new Solution Pack out of its box as shown.

8. Pull the red pin out of the new Solution Pack.

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9. Put the palms of your hands over the edges of the lid as shown.

10. Press down firmly and evenly with both hands until the tabs click into the 2 holes.
NOTE: For the Solution Pack to be activated correctly, both tabs must click in
place.

11. Tap the Action Completed button.

12. Put your thumbs on the white part of the Solution Pack and push the Solution Pack
into its compartment until it clicks in place.

The analyzer closes the inlet.

13. Enter necessary data.
14. Tap the OK button.

Can a Solution Pack be used again?

A Solution Pack removed from one analyzer can be used on another if these 3 condi-
tions are met:
• the Solution Pack is installed before its Scheduled to replace: date
• the Solution Pack is installed before its Expiration date:
• the Solution Pack has some remaining activities

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This data can be seen in the Solution Pack Status screen.

Related information
To see the Solution Pack status, page 38

Status logs

Status logs include all the data that tells something about the performance of a
consumable that has been removed from the analyzer. The data can be printed or
exported to a USB flash drive.

To print Solution Pack status logs

1. Tap Menu > Data logs > Replacement log.
2. Select the “Solution pack removed” activity.
3. Tap the Send status to printer button.

To export Solution Pack status logs

Prerequisite(s)
• A USB flash drive is available

1. Plug in the USB flash drive.

2. Tap Menu > Data logs > Replacement log.
3. Select the “Solution pack removed” activity.
4. Tap the Export status logs button.

Sensor Cassette

To see the Sensor Cassette status

1. Tap Menu > Analyzer status > Consumables.
2. For more information, tap the Status > Sensor Cassette buttons.

To replace the Sensor Cassette

Required item(s)

A new Sensor Cassette - SC90 A new Sensor Cassette - SC90 Ki

1. Tap Menu > Analyzer status.

2. Tap the Consumables > Replace > Sensor Cassette buttons.
3. Tap the Press to start video guidance button.
4. Check that you have the correct Sensor Cassette.
5. Wait until the Sensor Cassette compartment opens.

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6. Remove the Sensor Cassette and dispose of it as biohazardous waste.

7. Tap the Action Completed button.

8. Pull the foil off the new Sensor Cassette Pack, unscrew the lid and lift out the
Sensor Cassette.
9. Tap the Action Completed button.
10. Press the new Sensor Cassette in place.

11. Tap the Action Completed button.

12. Enter necessary data.
13. Tap the OK button.
NOTE: If you tap the Exit conditioning button, the startup aborts and measure-
ments can be started faster.
NOTE: Calibration errors are present and QCs will automatically run before you
can measure, unless Run built-in QCs after replacement and startup is disa-
bled.

Calibration frequency after a Sensor Cassette SC90 replacement

Calibrations are done more frequently in the 24-hour period that follows a Sensor
Cassette SC90 replacement. After a sensor cassette replacement, a calibration is
performed with every measurement for the first four hours.

NOTE: A calibration takes up to 2½ minutes.

Related information
Frequency of automatic calibrations, page 83

Can a Sensor Cassette be used again?

A Sensor Cassette removed from one analyzer can be used on the same or on another
ABL90 FLEX PLUS analyzer if these 6 conditions are met.
• The Sensor Cassette is kept right side up after its removal. This prevents damage to
the sensors.
• The Sensor Cassette is installed within 2 hours of its removal

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• The Sensor Cassette is installed before its Scheduled to replace date

• The Sensor Cassette is installed before its Expiration date
• The Sensor Cassette has some remaining activities
• The Sensor Cassette was not removed from an analyzer during a long-term shut-
down procedure

This data can be seen in the Sensor Cassette Status screen.

Status logs

Status logs include all the data that tells something about the performance of a
consumable that has been removed from the analyzer. The data can be printed or
exported to a USB flash drive.

To print Sensor Cassette status logs

1. Tap Menu > Data logs > Replacement log.
2. Select the “Sensor Cassette removed” activity.
3. Tap the Send status to printer button.

To export Sensor Cassette status logs

Prerequisite(s)
• A USB flash drive is available

1. Plug in the USB flash drive.

2. Tap Menu > Data logs > Replacement log.
3. Select the “Sensor cassette removed” activity.
4. Tap the Export status logs button.

Thermal printer paper

To replace the thermal printer paper

Required item(s)

A thermal paper roll

1. Tap Menu > Analyzer status.

2. Tap the Consumables > Replace > Paper buttons.

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3. Press the release button.

4. Open the cover and remove the used paper roll.

5. Put in the new paper roll. Make sure the paper unwinds from below.
6. Make sure some paper extends out of the printer.
7. Close the cover. The cover must click in place.
8. Tap the Replaced button.
9. Enter necessary data.
10. Tap the OK button.

Protection of printed data

NOTE: Do not expose data printed on the thermal printer paper of the analyzer to high
temperatures, high humidity, direct sunlight, water, alcoholic or organic solvents,
freshly-developed diazo copy sheets or materials that contain polyvinylchloride (PVC),
and do not scratch them. Keep the printed data in polyethylene, polypropylene or poly-
ester folders or boxes.

These precautions will help you to protect your printed data.

Inlet Module

To replace the Inlet Module

Required item(s)

A new Inlet Module

WARNING – Risk of infection

The used Inlet Module has been in contact with blood and must be handled as poten-
tially infectious.

1. Tap Menu > Analyzer status.

2. Tap the Other activities > Inlet check > Repl．inlet connector gasket
buttons.
NOTE: Only a new Inlet Module is necessary.
3. Tap the Press to start video guidance button.

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4. Pull off the inlet cover.

5. Tap the Action completed button.

The analyzer opens the inlet.
6. Hold the Inlet Module as shown and pull to the right.

7. Tap the Action completed button 4 times.

8. Make sure that the tabs on the inner side of the new Inlet Module are in the
correct position.

9. When the analyzer tells you to, hold the new Inlet Module as shown and push the
end into the inlet connector until it clicks in place.

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10. Tap the Action completed button.

The analyzer closes the inlet.
11. Put on the inlet cover.
12. Tap the Action completed button.

Inlet Gasket Holder

To replace the Inlet Gasket Holder

Required item(s)

A new Inlet Gasket Holder

WARNING – Risk of infection

Make sure you do not prick or scratch yourself on the Inlet Probe.
WARNING – Risk of infection
The used Inlet Gasket Holder has been in contact with blood and must be handled as
potentially infectious.

1. Tap Menu > Analyzer status.

2. Tap the Other activities > Inlet check > Repl. Inlet Gasket Holder buttons.
3. Tap the Press to start video guidance button.
4. Pull off the inlet cover.

5. Tap the Action completed button.

The analyzer opens the inlet.
6. Pull out the Inlet Gasket Holder.

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7. Tap the Action completed button.

8. Put the new Inlet Gasket holder over the slide and insert it. Make sure that the
Inlet Probe is in the center of the gasket.

NOTE: Make sure the Inlet Gasket Holder clicks in place.

9. Tap the Action completed button.
The analyzer closes the inlet.
10. Put on the inlet cover.
11. Tap the Action completed button.

Inlet Probe

To replace the Inlet Probe

Required item(s)

A new Inlet Probe

WARNING – Risk of infection

Make sure you do not prick or scratch yourself on the Inlet Probe.
WARNING – Risk of infection
The used Inlet Probe has been in contact with blood and must be handled as poten-
tially infectious.

1. Tap Menu > Analyzer status.

2. Tap the Other activities > Inlet check > Repl．inlet probe buttons.
3. Tap the Press to start video guidance button.
4. Pull off the inlet cover.

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5. Tap the Action completed button.

The analyzer opens the inlet.
6. Pull out the Inlet Gasket Holder.

7. Tap the Action completed button.

8. Lift up the Inlet Probe as far as it will go and pull it to the right to remove it.

9. Tap the Action completed button.

10. Hold the new Inlet Probe in a vertical position and put it in place.

11. Lower the Inlet Probe.

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12. Tap the Action completed button.

13. Put the new Inlet Gasket holder over the slide and insert it. Make sure that the
Inlet Probe is in the center of the gasket.

NOTE: Make sure the Inlet Gasket Holder clicks in place.

14. Tap the Action completed button.
The analyzer closes the inlet.
15. Put on the inlet cover.
16. Tap the Action completed button.

Inlet Connector Gasket

To replace the Inlet Connector Gasket

Required item(s)

A new Inlet Connector Gasket A pair of tweezers

Prerequisite(s)

WARNING – Risk of infection

The used Inlet Connector Gasket has been in contact with blood and must be handled
as potentially infectious.

1. Tap Menu > Analyzer status.

2. Tap the Other activities > Inlet check > Repl．inlet connector gasket
buttons.
3. Tap the Press to start video guidance button.
4. Pull off the inlet cover.

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5. Tap the Action completed button.

The analyzer opens the inlet.
6. Hold the Inlet Module as shown and pull to the right.

7. Make sure that the tabs on the inner side of the Inlet Module are in the correct
position.

8. Tap the Action completed button.

9. Pull out the Inlet Connector Gasket with a pair of tweezers.

10. Tap the Action completed button.

11. Put tap water on the new Inlet Connector Gasket.
12. Tap the Action completed button.

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13. Push the new Inlet Connector Gasket in place as shown.

14. Tap the Action completed button.

15. When the analyzer tells you to, hold the Inlet Module as shown and push the end
into the inlet connector until it clicks in place.

16. Tap the Action completed button.

The analyzer closes the inlet.
17. Put on the inlet cover.
18. Tap the Action completed button.

Maintenance

Cleaning

Cleaning - when is it necessary?

The analyzer must always be kept clean. Exterior surfaces, the Inlet Gasket and other
parts of the analyzer must be cleaned when they are contaminated with blood and/or
other liquids.

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To clean the inlet gasket

Required item(s)

A lint-free cloth

WARNING – Risk of infection

Make sure you do not prick or scratch yourself on the Inlet Probe.

1. Tap Menu > Analyzer status.

2. Tap the Other activities > Inlet check > Clean inlet gasket buttons.
3. Tap the Press to start video guidance button.
The analyzer opens the inlet.
4. Make sure the Inlet Probe is not bent. If it is bent, replace it.
5. Dampen a lint-free cloth with water.
6. Tap the Action completed button.
7. Gently wipe the inlet gasket and the area around it until it is clean.
8. Tap the Action completed button.
The analyzer closes the inlet.

To clean the touch screen

Required item(s)

A lint-free cloth

1. Lightly dampen a lint-free cloth with tap water.

2. Put your finger on a part of the screen that is not active and hold it there.
3. Gently wipe the screen.

To clean the analyzer exterior

Required item(s)

A lint-free cloth A mild detergent

NOTE: Radiometer has not tested whether cleaning wet wipes can be used for this
purpose.

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NOTE: The Sensor Cassette compartment and the top surface of the Solution Pack
compartment must be cleaned by a Radiometer representatives.

1. Lightly dampen a lint-free cloth with soapy water or a mild detergent.

2. Wipe the analyzer exterior.

To clean the QUALICHECK Opener/Adapter

Required item(s)

Any of the following:

• Demineralized water
A lint-free cloth • A mild detergent
• A solution of 70% iso-propyl alcohol (2-propanol)
• A solution of 70% ethanol
• A solution of 5% sodium hypochlorite

1. Lightly dampen a lint-free cloth with a recommended cleaning solution.

2. Gently wipe the QUALICHECK Opener/Adapter.

Disinfecting

Disinfection - when is it necessary?

Follow your local, state and federal guidelines.

To disinfect the touch screen

Required item(s)

A lint-free cloth A solution of 70 % alcohol

Prerequisite(s)
• The analyzer is clean
• Make sure you wear gloves when performing this task
• A solution of (2-propanol) or 70 % ethanol is available

NOTE: Follow the disinfectant manufacturer's instructions and the policies in place at
your institution as well as recommended practices.

1. Lightly dampen a lint-free cloth with disinfectant.

2. Put your finger on a part of the screen that is not active and hold it there.

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3. Gently wipe the screen and keep it moist for 1 minute.

4. Allow the surface to air-dry before use.

To disinfect the analyzer exterior

Required item(s)

A lint-free cloth A solution of (2-propanol) or 70 % ethanol

Prerequisite(s)
• The analyzer is clean
• Make sure you wear gloves when performing this task
• A solution of 70 % iso-propyl alcohol (2-propanol), 70 % ethanol or 5 % sodium
hypochlorite is available

NOTE: Follow the disinfectant manufacturer's instructions and the policies in place at
your institution as well as recommended practices.

1. Lightly dampen a lint-free cloth with disinfectant.

2. Wipe the analyzer exterior and keep it moist for 1 minute.
3. Allow the surface to air-dry before use.

NOTE: Radiometer has tested that these solutions can be used once a week for 10
years.
NOTE: Radiometer has not tested whether disinfection wet wipes can be used for this
purpose.
NOTE: The Sensor Cassette compartment and the top surface of the Solution Pack
compartment must be disinfected by a Radiometer representative.

To disinfect the fluid transport system

1. Do the long-term shutdown procedure.

Battery

To recharge the analyzer battery

1. Connect the analyzer to the mains power supply.

To install and service the battery

1. Contact your local Radiometer representative.

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Disposal

To dispose of the analyzer

Contact your local Radiometer representative for instructions.

Connecting peripherals

To connect a USB external keyboard / mouse

Required item(s)

A USB keyboard/mouse

1. Connect the external keyboard/mouse cable to the appropriate port on the rear of
the analyzer.
NOTE: The analyzer will find the connection to the external keyboard/mouse
immediately.

To connect a non-USB (PS/2) external keyboard or mouse

Required item(s)

A non-USB (PS/2) external

keyboard or mouse

NOTE: For analyzers with port layout 1 only.

1. Do a temporary shutdown.
2. Connect the external keyboard/mouse cable to the appropriate port on the rear of
the analyzer.
3. Restart the analyzer.

To connect an external barcode reader

1. Contact your local Radiometer representative.

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To connect the analyzer to a network

Required item(s)

A RJ45 connector

1. Connect the network cable to the network connector and the network cable port of
the analyzer.
NOTE: If the analyzer is set up for connection to a LIS/HIS or AQURE/RADIANCE
system, the analyzer will find the network connection immediately.

Reference

1. Clinical laboratory waste management. CLSI/NCCLS document GP5-A2, Clinical

Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Penn-
sylvania 19087-1898 USA.

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Overview of quality control management

Quality control management is important as it evaluates the performance of the

analyzer to make sure that the patient results are accurate and precise.

The analyzer manages quality control automatically, but if local, federal or state regula-
tions require additional quality control procedures, operators can do them.

To find the status of QC measurements

1. Tap Menu > Analyzer status.
2. Tap the Quality control button.
NOTE: A symbol in the Solution column shows the status of a QC measurement.

Symbols that show the status of QCs

Symbol Indication

The QC measurement was completed successfully

An error was found on one or more QC result

A scheduled QC measurement is pending. The last QC was completed successfully.

A scheduled QC measurement is pending. The last QC was not completed successfully.

Automatic quality control management

About automatic quality control management

Automatic quality control management (AQM) is the name given to quality control
procedures that the analyzer is programmed to do automatically.

Automatic quality control management

Name of the proce- Description

dure

System checks Automatic test sequences done with each measurement and at other
times to make sure that all parts of the analyzer operate within specifi-
cations.

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Automatic quality control management

Name of the proce- Description

dure

Built-in QC These are liquid QC measurements that are automatically done by the
analyzer.

The 3 QC solutions in the Solution Pack are used for these measure-
ments.

Apply statistical rules Helps operators to find errors, shifts, and trends. Symbols on results
to QC results. show when rules are violated.

For example: Westgard Rules and RiLiBÄK rules (used in Germany).

NOTE: The analyzer must be set up to do this.

Apply corrective action The default corrective action for QC errors:

for QC errors • The color of the traffic light adjacent to the Quality control button
in the Analyzer status screen changes to yellow
• The parameter tab changes to yellow
• The ? symbol will be shown on the parameter in patient results

NOTE: The default settings can be changed.

Repress a parameter if NOTE: The analyzer must be set up to do this.

there are any problems
• Patient results will not include results for parameters with QC errors
• The parameter tab changes to red

Lock the analyzer until NOTE: The analyzer must be set up to do this.
requested
ampoule-based QC
measurements are NOTE: Patient samples cannot be analyzed while the analyzer is
done after a Solution locked.
Pack and/or Sensor
Cassette replacement

Related information
To set up and enable Westgard Rules, page 187
To add a new RiLiBÄK rule, page 188
To repress a parameter, page 169
To set up corrective action for errors in QC results, page 183
To request ampoule-based QC measurements after replacements, page 183

About system checks

Automatic test sequences done with each measurement and at other times to make
sure that all parts of the analyzer operate within specifications.

The analyzer automatically takes action to correct a problem it finds. If the action fails,
a message is shown and the analyzer goes into the Operator Action Needed, Trou-
bleshooting needed or Intervention Required mode. In these modes operators are
given instructions about what to do.

Results of failed system checks are recorded in the Activity log.

Overview of automatic quality management

Here is an overview of the default schedule for system checks, QC and calibration
measurements that the analyzer does to make sure that patient results are accurate,
precise and reliable.

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Start of the system-check cycle

System checks

Built-in QC measurements

Sensitivity calibration of pCO2, cGlu, cLac, cCrea*, cUrea/BUN*, and status calibration of
the oximetry parameters

Sensitivity calibration of pH and the electrolytes (cK+, cNa+,cCa2+, cCl–)

Sensitivity calibration of pO2

Calibration of cCrea* and cUrea/BUN*

A status calibration of all parameters (except the oximetry parameters) is done before
every patient, QC and sensitivity calibration measurement.

* Parameters only available on analyzers configured to feature creatinine and

urea/BUN.
Related information
Details about calibration frequency, page 174

Built-in QC

About built-in QC measurements

The analyzer uses the three levels of QC solution contained in the Solution Pack to do
built-in QC measurements. These QC solutions are automatically registered in slots A,
B and C when a Solution Pack is installed.

NOTE: For SP90, the solution in slot A is S9030, the solution in slot B is S9040 and the
solution in slot C is S9050.

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NOTE: For SP90 Ki, the solution in slot A is S9230, the solution in slot B is S9240 and
the solution in slot C is S9250.

Built-in QC measurement frequency

A built-in QC measurement is scheduled by default to be done every 8 hours. One

measurement a day is done with each QC solution. Built-in QC measurements are also
scheduled by default to be done in connection with these activities:

• Replacement of the Solution Pack

• Replacement of the Sensor Cassette
• Startup

You can edit the schedule for built-in QC measurements.

To request an unscheduled built-in QC measurement

Prerequisite(s)
• Make sure that the analyzer is Ready

1. Tap Menu > Analyzer status > Quality control.

2. Select a QC solution in the Built-in QC field.
3. Tap the Start QC button.
The result of the QC measurement is saved in the Quality control log.

Built-in QC results

Status of built-in QC measurements

The symbols in the Solution column of the Quality control part of the Analyzer
status screen shows the overall status of each QC measurement.

Symbol Description

The QC measurement was successful

An error was found on one or more parameter result.

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To find a built-in QC result

1. Choose an option and follow the steps for it.
Option Steps

To find a result in the a) Tap Menu > Data logs > Quality control log.
data log b) Select the measurement.
NOTE: Built-in QC measurements are done with solu-
tions in slots A, B and C.
c) Tap the Result button.

To find a number of a) Filter the data from the Quality control log.
results in the data log

To find the latest a) Tap Menu > Analyzer status > Quality control.
result b) In the Built-in QC field, select the measurement.
c) Tap the Result button.

Related information
To filter data from the Quality control log, page 81

Symbols on built-in QC results

Problems on built-in QC results are marked with one or more of the symbols shown in
the table.

Symbol Description

An error was found. A message attached to the result describes the error.

The result is outside the control range, but inside the statistical range. Results inside
the statistical range are included in statistics.

The result is outside the statistical range. The result is not included in statistics

The result is outside the range of indication. The result is not included in statistics

..... The result could not be calculated. When possible, an interpretation of the message is
attached.

* Operator-defined slope/offset corrections were used to calculate the result

W The result violates a Westgard rule

R The result violates a RiliBÄK rule

Related information
About range of indication, page 161
Glossary of quality control terms, page 176

To see messages on built-in QC results

1. Tap Menu > Data logs > Quality control log.
2. Select the measurement.
NOTE: QC solutions used for built-in QC measurements are automatically regis-
tered in slots A, B and C.
3. Tap the Result button.
4. Tap the Messages button.

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To troubleshoot messages on built-in QC results

Prerequisite(s)
• You can see the message you want to troubleshoot

1. Select the message.

2. Tap the Troubleshoot button.
3. Follow the instructions on the screen.

Quality control management done by

operators
Quality control management that can be done by operators

The analyzer manages quality control automatically, but if local, federal or state regula-
tions require additional quality control (QC) procedures, they can be done. These
procedures are called ampoule-based QC measurements.

QC procedures Description

Ampoule-based QC measure- Manual QC measurements done with QC ampoules

ments
NOTE: If local, federal or state regulations require that
analyzer-specific control ranges be established for the QC solu-
tions used for ampoule-based QC measurements, it can be
done.

Ampoule-based QC measure- The analyzer is locked until requested ampoule-based QC

ments after Solution Pack measurements are done.
and/or Sensor Cassette
replacements NOTE: The analyzer must be set up to do this.

Calibration verification meas- Measurements that let you verify the calibration and reportable
urements (for example in the range of measured parameters
USA).
NOTE: This procedure requires control material to be analyzed
as patient samples.

Related information
To do an ampoule-based QC measurement from the start screen, page 67
To do a Radiometer ampoule-based QC measurement from the Analyzer status screen,
page 65
To request ampoule-based QC measurements after replacements, page 183
About calibration verification, page 70

Ampoule-based QC measurements

QC solutions for ampoule-based measurements

Radiometer recommends that Radiometer QC solutions are used for ampoule-based QC

measurements.
NOTE: If non-Radiometer QC solutions are used, Radiometer cannot guarantee accu-
rate, valid QC results.

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How to get good ampoule-based QC measurement results

To get good ampoule-based QC measurement results, follow the listed advice.

• For Radiometer solutions only:

◦ Check that there are no calibration errors before you do an ampoule-based QC
measurement.
◦ Keep the QC solution under the correct storage conditions. See the product
insert.
◦ Hold the ampoule between the thumb and first finger when you shake it.
◦ Shake the ampoule vigorously for 15 seconds before it is opened.
◦ Use the Radiometer QUALICHECK Opener/Adapter to hold the ampoule during the
QC measurement.
◦ Use the prepared QC solution immediately after the ampoule is opened.
◦ Use the ampoule for one QC measurement only.
◦ Enter the correct ampoule temperature in the Quality control identification
screen during the QC measurement.

• For non-Radiometer QC solutions:

◦ Check that there are no calibration errors before you do an ampoule-based QC
measurement.
◦ Keep the QC solution under the correct storage conditions. See the product
insert.
◦ Prepare the QC solution for use correctly. Follow the manufacturer's instructions.

To prepare a Radiometer QC ampoule for use

Required item(s)

A Radiometer QC ampoule A QUALICHECK Opener/Adapter Gloves

Prerequisite(s)
• The Radiometer QUALICHECK box that contains the QC ampoules has been stored
at a constant temperature (18-32 °C) for 5 hours.
• Make sure you wear gloves when performing a QC measurement

NOTE: If there are errors on calibration results, they will be shown on the
ampoule-based QC results.

1. Remove a QC ampoule from its box.

2. Close the box.
NOTE: The ampoules are sensitive to light.
3. Hold the ampoule between your thumb and first finger and shake it vigorously for
a minimum of 15 seconds.
4. Hold the ampoule neck-side up and tap the top until all the solution collects in the
lower part of the ampoule.

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5. Put the ampoule in the QUALICHECK Opener/Adapter.

6. Apply pressure in the direction shown, to break off the neck of the ampoule.

7. Put the ampoule in the QUALICHECK Opener/Adapter.

8. Do an ampoule-based QC measurement immediately.

Related information
Quality control products – code numbers, page 378
Quality control products – code numbers, page 378

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To do a Radiometer ampoule-based QC measurement from the

Analyzer status screen

Required item(s)

A Radiometer QC ampoule A QUALICHECK Opener/Adapter Gloves

Prerequisite(s)
• An Ampoule - QC mode is set up
• The QUALICHECK5+ / QUALICHECK7+ solution is registered for use on the analyzer
• The QUALICHECK5+ / QUALICHECK7+ ampoule is prepared for use
• Make sure that the analyzer is Ready
• Make sure you wear gloves when performing a QC measurement

WARNING – Risk of infection

Make sure you do not prick or scratch yourself on the Inlet Probe.

NOTE: If there are errors on calibration results, they will be shown on the
ampoule-based QC results.
NOTE: The insert control ranges of Radiometer QC solutions are determined at a refer-
ence temperature of 25 °C. It is therefore important to enter the correct ampoule
temperature during QC measurements so the analyzer can temperature-correct QC
results.

If the correct temperature is not entered, this will have an effect on pH, pCO2 and pO2
results. At temperatures above 25 °C, pH results will be too high and pCO2 and pO2
results will be too low. At temperatures below 25 °C, pH results will be too low and
pCO2 and pO2 results will be too high.
NOTE: Radiometer QC ampoules are for single use only.

1. Tap Menu > Analyzer status > Quality control.

2. Hold the QUALICHECK Opener/Adapter with the QC ampoule and tap the Syringe
button.
The analyzer opens the inlet.
3. Select the correct lot of QC solution in the Ampoule-based QC field.
NOTE: QC solutions are identified by a Solution name (for example, S7730) and
a Lot number.
4. Tap the Start Ampoule QC button.
5. Turn the QUALICHECK Opener/Adapter with the ampoule so the Radiometer logo
faces upwards.
6. Put the QUALICHECK Opener/Adapter with the ampoule over the inlet gasket.

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7. Push the QUALICHECK Opener/Adapter with the ampoule into the analyzer as far
as it will go and hold it there.

8. Hold the QUALICHECK Opener/Adapter with the ampoule in the pushed-in position
until the analyzer tells you to remove it.

9. When the analyzer tells you to, remove the QUALICHECK Opener/Adapter with the
ampoule.
The analyzer closes the inlet.
10. Make sure the Solution: field is selected.
11. Make sure that there is only one lot of the QC solution.
NOTE: QC solutions are identified by a Solution name (for example, S7730) and
a Lot number.
12. If there is only one lot, go to step 12.
13. If there is more than one lot, select the correct lot of QC solution.
14. Enter the ampoule temperature.
NOTE: It is important to enter the correct temperature. See the note above.
15. Enter other necessary data in the Quality control identification screen.
16. Tap the Result button.
17. Remove the ampoule from the QUALICHECK Opener/Adapter and discard the
ampoule as biohazardous waste.

Related information
To register a Radiometer QC solution for ampoule-based QC measurements, page 177

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To do an ampoule-based QC measurement from the start screen

Required item(s)

A Radiometer QC ampoule A QUALICHECK Opener/Adapter Gloves

Prerequisite(s)
• A QC measuring mode is set up
• The QC solution is registered for use on the analyzer
• The QC ampoule is prepared for use
• Make sure that the analyzer is Ready
• Make sure you wear gloves when performing a QC measurement

WARNING – Risk of infection

Make sure you do not prick or scratch yourself on the Inlet Probe.

NOTE: If there are errors on calibration results, they will be shown on the
ampoule-based QC results.
NOTE: The insert control ranges of Radiometer QC solutions are determined at a refer-
ence temperature of 25 °C. It is therefore important to enter the correct ampoule
temperature during QC measurements so the analyzer can temperature correct QC
results.

If the correct temperature is not entered, this will have an effect on pH, pCO2 and pO2
results. At temperatures above 25 °C, pH results will be too high and pCO2 and pO2
will be too low. At temperatures below 25 °C, pH will be too low and pCO2 and pO2
results will be too high.
NOTE: Radiometer QC ampoules are for single use only.

1. Hold the QUALICHECK Opener/Adapter with the QC ampoule and tap the Syringe
button.
The analyzer opens the inlet.
2. Tap the Ampoule - QC button.
3. Turn the QUALICHECK Opener/Adapter with the ampoule so the Radiometer logo
faces upwards.
4. Put the QUALICHECK Opener/Adapter with the ampoule over the inlet gasket.
5. Push the QUALICHECK Opener/Adapter with the ampoule into the analyzer as far
as it will go and hold it there.

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6. Hold the QUALICHECK Opener/Adapter with the ampoule in the pushed-in position
until the analyzer tells you to remove it.

7. When the analyzer tells you to, remove the QUALICHECK Opener/Adapter with the
ampoule.
The analyzer closes the inlet.
8. Make sure the Solution: field is selected.
9. Make sure that there is only one lot of the QC solution.
NOTE: QC solutions are identified by a Solution name (for example, S7730) and
a Lot number.
10. If there is only one lot, go to step 12.
11. If there is more than one lot, select the correct lot of QC solution.
12. Enter the ampoule temperature.
NOTE: It is important to enter the correct temperature. See the note above.
13. Enter other necessary data in the Quality control identification screen.
14. Tap the Result button.
15. Remove the ampoule from the QUALICHECK Opener/Adapter and discard the
ampoule as biohazardous waste.

Related information
To request an unscheduled calibration from the Analyzer status screen, page 85
To register a Radiometer QC solution for ampoule-based QC measurements, page 177

To edit QC identification data

NOTE: You can only edit the Department, Operator and Note fields.

1. Tap Menu > Data logs > Quality control log.

2. Select a measurement done with the QC solution you want to edit.
NOTE: QC solutions are identified by a Solution name (for example, S7730) and
Lot number.
3. Tap the Result button.
4. Tap the QC ID button.
5. Edit the necessary data.

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Ampoule-based QC results

Status of ampoule-based QC measurements

The symbols in the Solution column of the Quality control part of the Analyzer
status screen shows the overall status of each QC measurement.

Symbol Description

The QC measurement was successful

An error was found on one or more parameter result.

To find an ampoule-based QC result

1. Tap Menu > Data logs > Quality control log.
2. Select the solution.
3. Tap the Result button.

Symbols on ampoule-based QC results

Problems on ampoule-based QC results are marked with one or more of the symbols
shown in the table.

Symbol Description

An error was found. A message attached to the result describes the error.

The result is outside the control range, but inside the statistical range. Results inside
the statistical range are included in statistics.

The result is outside the statistical range. The result is not included in statistics.

The result is outside the range of indication. The result is not included in statistics.

..... The result could not be calculated. When possible, an interpretation of the message is
attached.

* Operator-defined slope/offset corrections were used to calculate the result

W The result violates a Westgard rule

R The result violates a RiliBÄK rule

Related information
About range of indication, page 161
Glossary of quality control terms, page 176

To see messages on ampoule-based QC results

1. Tap Menu > Data logs > Quality control log.
2. Select the solution.
3. Tap Result button.
4. Tap the Messages button.

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To troubleshoot messages on results

Prerequisite(s)
• You can see the message you want to troubleshoot

1. Select the message.

2. Tap the Troubleshoot button.
3. Follow the instructions on the screen.

Calibration verification
About calibration verification

Some local, state or federal regulations require calibration verification to be done (for
example, in the USA). Calibration verification is a process that lets you verify the cali-
bration and reportable range of the parameters measured by the analyzer.

Calibration verification is a 3-stage process:

• Stage 1: Analyze as patient samples a minimum of three different levels of QC

solution.
NOTE: On the analyzer, these measurements are referred to as calibration verifica-
tion measurements.
• Stage 2: Use the calibration-verification measurement results to verify the calibra-
tion and reportable range of the measured parameters. Follow your local, state and
federal guidelines.
• Stage 3: If necessary, change the reportable range of parameters.
Related information
To set up reportable ranges, page 160

Frequency of calibration verification

Follow your local, state or federal regulations.

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Stage 1 - Analyzing different levels of control solution

To prepare a Radiometer calibration-verification ampoule for use

Required item(s)

A Radiometer QC ampoule A QUALICHECK Opener/Adapter Gloves

Prerequisite(s)
• The Radiometer QUALICHECK box that contains the QC ampoules for calibration
verification has been stored at a constant temperature (18-32 °C) for 5 hours.
• Make sure you wear gloves when performing a QC measurement
NOTE: If there are errors on calibration results, they will be shown on the calibra-
tion-verification results.

1. Remove a QC ampoule from its box.

2. Close the box.
NOTE: The ampoules are sensitive to light.
3. Hold the ampoule between your thumb and first finger and shake it for a minimum
of 15 seconds.
4. Hold the ampoule neck-side up and tap the top until all the solution collects in the
lower part of the ampoule.
5. Put the ampoule in the QUALICHECK Opener/Adapter.

6. Apply pressure in the directions shown, to break off the neck of the ampoule.

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7. Put the ampoule in the QUALICHECK Opener/Adapter.

8. Do a calibration-verification measurement immediately.

To do a calibration-verification measurement

Required item(s)

A Radiometer QC ampoule A QUALICHECK Opener/Adapter Gloves

Prerequisite(s)
• A calibration-verification mode has been set up
• The calibration-verification control solution is prepared for use
• Make sure that the analyzer is Ready
• Make sure you wear gloves when performing a QC measurement

WARNING – Risk of infection

Make sure you do not prick or scratch yourself on the Inlet Probe.

NOTE: Radiometer calibration-verification ampoules are for single use only.

1. Tap the Syringe button.

The analyzer opens the inlet.
2. Tap the Cal．Verification button.
3. Turn the QUALICHECK Opener/Adapter with the ampoule so the Radiometer logo
faces upwards.
4. Put the QUALICHECK Opener/Adapter with the ampoule over the inlet gasket.
5. Push the QUALICHECK Opener/Adapter with the ampoule into the analyzer as far
as it will go and hold it there.

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6. Hold the QUALICHECK Opener/Adapter with the ampoule in the pushed-in position
until the analyzer tells you to remove it.

7. When the analyzer tells you to, remove the QUALICHECK Opener/Adapter with the
ampoule.
The analyzer closes the inlet.
8. Enter enough information to identify the calibration-verification control solution in
the Patient ID field.
NOTE: Enter a maximum of 20 characters. If more are entered they will not be
sent to LIS/HIS and/or AQURE/RADIANCE systems.
9. If necessary, enter a note.
10. Tap the Result button.
NOTE: Results are not temperature-corrected. If the ampoule temperature was
not 25 °C, you must temperature-correct the results manually. Results are saved
in the Patient results log.
11. Remove the ampoule from the QUALICHECK Opener/Adapter and dispose of it as
biohazardous waste.

Post-requisite: Do calibration-verification measurements with a minimum of 3 levels of

calibration-verification control solution.
Related information
To set up a calibration-verification mode, page 157
To temperature correct calibration-verification results based on Range+ QUALICHECK
measurements, page 74

Stage 2 - Using results to verify reportable ranges

To find a calibration-verification measurement result

Calibration-verification results are saved in the Patient result log. The results are
identified as “Cal．Verification” in the Sample type column.

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NOTE: Results for pH, pCO2 and pO2 must be corrected if the temperature of the
ampoule during the measurement was above or below 25 °C.

1. Tap Menu > Data logs > Patient results log.

2. Tap the Filter button.
3. In the Criteria frame, choose an option and follow the steps for it.
Option Steps

To select a time period prior to Tap the number button for the number of
today's date days you want

To select a start and end date Enter data in the Start date: and End date:
fields
4. For Sample type, select “Cal．Verification”.
5. Tap the Apply button.
6. Select the measurement.
7. Tap the Result button.
NOTE: The result must be temperature corrected.

Symbols on calibration-verification measurement results

Problems on calibration-verification results are marked with one or more of the

symbols shown in the table.

Symbol Description

An error occurred. A message attached to the result describes the error

The result is above the upper limit of the reportable range

The result is below the lower limit of the reportable range

..... No result could be calculated or the result is outside the range of indication of the
analyzer

* Operator-defined correction factors were used to calculate the result

Related information
About range of indication, page 161
About reportable ranges, page 160

To temperature correct calibration-verification results based on

Range+ QUALICHECK measurements

NOTE: Results for pH, pCO2 and pO2 must be corrected if the temperature of the
ampoule during measurements was above or below 25 °C.

1. Find the temperature constant (A) in the table.

Radiometer calibration-verification control solutions (Range+ QUALICHECK prod-

ucts)

Parameter Temperature constants (A)

Level 1 Level 2

pH 0.0013 0.0026

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Radiometer calibration-verification control solutions (Range+ QUALICHECK prod-

ucts)

Parameter Temperature constants (A)

Level 1 Level 2

pCO2 –0.0056 –0.0071

pO2 –0.0098 –0.0107

NOTE: It is not necessary to temperature correct the results for Range+ QUALI-
CHECK solution level 3.
2. Use the equations in the table to correct results for parameters that were meas-
ured at temperatures above or below 25 °C.

Parameter Equation for temperature correction

pH pHcorrected to 25 °C = pHmeasured – A (t – 25)

pCO2 (pCO2)corrected to 25 °C = (pCO2)measured × [1 – A (t – 25)]

pO2 (pO2)corrected to 25 °C = (pO2)measured × [1 – A (t – 25)]

Example:

The pH calibration-verification measurement result was 7.100 for a level 1 solution.

The temperature of the ampoule during the measurement was 32 °C not 25 °C. The
result must therefore be corrected.

The temperature constant for a level 1 solution for pH is 0.0013.

The equation for temperature correction of pH values is:

pHcorrected to 25 °C = pHmeasured – A (t – 25) = 7.100 – 0.0013 (32 – 25) = 7.091

To use temperature-corrected calibration-verification results

Prerequisite(s)
• Temperature-corrected calibration-verification results

1. Use the results to verify the reportable range of all measured parameters. Follow
your local, state or federal guidelines.

To temperature correct QUALICHECK7+ pH, pO2 and pCO2 control

ranges

The assigned value and limits of the control range given for pH, pO2 and pCO2 in the
QUALICHECK7+ Control ranges insert were measured at 25 °C. The assigned value and
limits are temperature-dependent. When QUALICHECK7+ material is used for calibra-
tion-verification and linearity checks at other temperatures, it is necessary to manually
temperature correct these values.

1. In the Control ranges insert, find and note the following for pH, pO2 and pCO2:
a) The upper limit of the control range.
b) The lower limit of the control range.
c) The assigned value.
2. Note the temperature at which the ampoule was conditioned (in degrees Celsius):
(t ºC).

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3. Find the temperature constant (A) in the table.

Radiometer QUALICHECK7+ material

Param- Temperature constants (A)

eter
Level 0 Level 1 Level 2 Level 3 Level 4

S7620 S7630 S7640 S7650 S7660

pH 0.00288 0.00225 0.00161 0.000964 0.000714

pCO2 0.00791 0.00383 0.00267 0.00100 0.000220

pO2 0.00543 0.0104 0.00851 0.00906 0.00887

4. Find the temperature constant (B) in the table.

Radiometer QUALICHECK7+ material

Param- Temperature constants (B)

eter
Level 0 Level 1 Level 2 Level 3 Level 4

S7620 S7630 S7640 S7650 S7660

pH -0.00000765 0.0000459 0.0000357 0.0000153 0.0000204

pCO2 -0.0000426 0.000132 0.0000738 0.0000432 0.0000315

pO2 -0.000125 -0.000181 - 0.0000769 -0.000110 -0.000348

5. Use the equations in the table to calculate the temperature- corrected values of
the assigned value and lower- and upper limits of the control ranges for each
parameter. That is, the values at temperature t °C.

Parameter Equation for temperature correction

pH pH(t °C) = pH(25°C) + A(t – 25) + B(t – 25)2

pCO2(25 °C)
pCO2(t °C) =
pCO2 1 + A(t - 25) + B(t - 25)2

pO2(25 °C)
pO2(t °C) =
pO2 1 + A(t - 25) + B(t - 25)2

Where:
t = Temperature of the QUALICHECK7+ ampoule during measurements
pH (t °C), pO2 (t °C) and pCO2 (t °C) = Temperature-corrected values
pH (25 °C), pO2 (25 °C) and pCO2 (25 °C) = Values given in the lot-specific QUAL-
ICHECK7+ Control ranges insert
NOTE: Calibration-verification and linearity-check measurement results can now
be checked to see that they are within the temperature-corrected control range of
the relevant parameter.

To age correct QUALICHECK7+ control ranges for cCrea

Even when QUALICHECK7+ material is stored refrigerated, creatinine (cCrea) is slowly

converted to creatine over time. The assigned value and control range given for cCrea
in the QUALICHECK7+ Control ranges insert were measured on the date the material
was manufactured (day zero). The values are age-dependent. When QUALICHECK7+

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material is used for calibration verification and linearity checks it is necessary to

manually age correct them.

1. In the lot-specific QUALICHECK7+ Control ranges insert, find and note:

a) The upper limit of the control range for cCrea.
b) The lower limit of the control range for cCrea.
c) The assigned value for cCrea.
d) The date of manufacture of the QUALICHECK7+ material.

It is the date printed alongside the symbol.

2. Note the date the measurement was done.
3. Calculate the age of the material in days:
ad = Number of days between the date of manufacture and the date the measure-
ment was done.
4. Convert the age of the material in days to the age of the material in months:
am = ad/30.5
5. Round the am value to the nearest whole number: a.
6. Use the following equation to calculate the age-corrected values of the assigned
value and the lower- and upper limits of the control range. That is, the values on
the day the measurements were done:
cCreaa = cCreai × [1 + (r × a)]
Where:
cCreaa = age-corrected value
cCreai = values read from the insert and noted in step 1 of this procedure.
r = rate constant = –0.00324215
a = age (in whole months) of the QUALICHECK7+ material used for the measure-
ments.
NOTE: Calibration-verification and linearity-check measurement results can now
be checked to see that are within the age-corrected cCrea control range.

To use corrected QUALICHECK7+ control ranges

Prerequisite(s)
Corrected QUALICHECK7+ control ranges

1. Use the control ranges to verify the reportable range of all measured parameters.
Follow your local, state or federal guidelines.

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To temperature correct pH, pCO2 and pO2 results based on

QUALICHECK7+ material

NOTE: Results for pH, pCO2 and pO2 are temperature-dependent. The assigned value
and control range given for these parameters in the QUALICHECK7+ Control ranges
insert were measured at 25 °C. When QUALICHECK7+ material is used for purposes
other than ampoule-based QC measurements, calibration verification or linearity
checks, pH, pCO2 and pO2 results must be temperature corrected to 25 °C manually.

1. Find the temperature constant (A) in the table.

Radiometer QUALICHECK7+ material

Parameter Temperature constants (A)

Level 0 – Level 1 – Level 2 – Level 3 – Level 4 –

S7620 S7630 S7640 S7650 S7660

pH 0.00288 0.00225 0.00161 0.000964 0.000714

pCO2 0.00791 0.00383 0.00267 0.00100 0.000220

pO2 0.00543 0.0104 0.00851 0.00906 0.00887

2. Find the temperature constant (B) in the table.

Radiometer QUALICHECK7+ material

Param- Temperature constants (B)

eter
Level 0 Level 1 Level 2 Level 3 Level 4

S7620 S7630 S7640 S7650 S7660

pH -0.00000765 0.0000459 0.0000357 0.0000153 0.0000204

pCO2 -0.0000426 0.000132 0.0000738 0.0000432 0.0000315

pO2 -0.000125 -0.000181 - 0.0000769 -0.000110 -0.000348

3. Use the equations in the table to correct results for parameters that were meas-
ured at an ampoule temperature of t °C.

Parameter Equation for temperature correction

pH pHcorrected to 25 °C = pHmeasured – A (t – 25) – B(t – 25)2

pCO2 (pCO2)corrected to 25 °C = (pCO2)measured × [1 +A (t – 25) + B(t –25)2 ]

pO2 (pO2)corrected to 25 °C = (pO2)measured × [1 +A (t – 25) + B(t –25)2]

To age correct cCrea results based on QUALICHECK7+ material

Creatinine (cCrea) is slowly converted to creatine over time even when QUALI-
CHECK7+ material is stored refrigerated. The assigned value and control range given
for cCrea in the QUALICHECK7+ Control ranges insert were measured on the date of
manufacture (day zero). When QUALICHECK7+ material is used for other measure-
ments than ampoule-based QC measurements, cCrea results must be age corrected to
day zero manually.

1. In the QUALICHECK7+ Control ranges insert, find and note the date of manufac-
ture of the QUALICHECK7+ material.

It is the date printed alongside the symbol.

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2. Note the date the measurement was done.

3. Calculate the age of the material in days (ad) = Number of days between the date
of manufacture and the date of the measurement.
4. Convert the age of the material in days to the age of the material in months (am):
am = ad / 30.5
5. Round the amonths value to the nearest whole number: a.
6. Use the following equation to age correct cCrea results:
cCream
cCrea0 =
1+r´a
Where:
cCrea0 = Age-corrected result
cCream = Measurement result on the analyzer
r = rate constant = –0.00324215
a = age (in whole months) of the QUALICHECK7+ material used for the measure-
ment

Stage 3 - Changing reportable ranges

To change the reportable range of parameters

Prerequisite(s)
• New reportable ranges established during calibration verification

1. Tap Menu > Utilities > Setup > Analysis setup > Reportable ranges.
2. Select the parameter in the Parameters field.
3. Enter new values for the upper and lower limits of the reportable range.
4. If necessary, do steps 2 and 3 again for each parameter.
5. Tap the Close button.

Reviewing QC statistics
To find and print QC statistics

Only QC results that are within the statistical range are included in the QC statistics.

NOTE: You can only print QC statistics for one month at a time.

1. Tap Menu > Data logs > Quality control log.

2. Tap the Statistics button.
3. Tap the Next param．or Prev．param．button to see statistics for other parame-
ters.
4. Tap the Print button.

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5. Choose an option and follow the steps for it.

Option Steps

To print statistics for • Select the Print lot-to-date check button.

the lot to date • Tap the Print button.
NOTE: This option is only available when a minimum
number of QC measurements have been done.

To print statistics for • Select the Print for period check button.
a period • Select the calendar month period in the Print for
period frame.
• Tap the Print button.

NOTE: QC statistics are printed for all parameters.

Related information
Glossary of quality control terms, page 176

QC plots

QC plots are Levey-Jennings plots that show QC results done with registered QC solu-
tions. The results are shown on a horizontal time axis.

5
Slot A:S9030
1 7.194
6
2 8/12/2009
05:59 PM 7
3 7.170
8
4
7.154

10

1 Line to show the upper limit of the 6 Date that the highlighted QC meas-
control range of the solution urement was done

2 Line to show when the current 7 Time that the highlighted QC

control range of the solution was measurement was done
changed, or a new lot of the QC
solution was registered

3 Mean value of the control range of 8 QC result for the selected QC

the solution measurement

4 Line to show the lower limit of the 9 The absolute value of the lower
control range of the solution limit of the control range of the
solution

5 The absolute value of the upper 10 A previous QC measurement done

limit of the control range of the with the solution
solution

To find a QC plot
1. Tap Menu > Data logs > Quality control log.
2. Tap the Plot button.

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3. Select a parameter.
4. Tap the Ampoule QC <number...> button to see plots for ampoule-based QC
measurements.
5. Tap within the plot for a specific QC solution.
6. Use the scroll buttons to select and see details about specific QC measurements.

To filter data from the Quality control log

1. Tap Menu > Data logs > Quality control log.
2. Tap the Filter button.
3. In the Criteria frame, choose an option and follow the steps for it.
Option Action

To select a time period prior to Tap the number button for the number of
today's date days you want.

To select a start and end date Enter data in the Start date: and End date:
fields.
4. Select the Solution.
5. Select the Lot.
6. If necessary, select other criteria.
7. Tap the Apply button.

To see trends in QC results

Prerequisite(s)
• You have filtered the QC results from the Quality control log

1. Tap the Trend button.

2. Select check buttons for the parameters you want to see trends of.
3. Tap the View trend button.

WDC file export

About WDC

WDC is the abbreviation for Worldwide DATACHECK system. You can use the Worldwide
DATACHECK system to compare the performance of your analyzer with the perform-
ance of the same type of analyzer in various peer groups.

To export WDC files

Prerequisite(s)
• A storage device (for example, a USB flash drive or an external network) is avail-
able
• A folder for the monthly statistics has been created on the device

1. Connect the storage device to the analyzer.

2. Tap Menu > Utilities > Disk functions > WDC report.
3. Tap the button in the Destination frame.
4. Select the folder where the QC statistics are to be exported.
5. Tap the Back button.
6. Select the monthly period.

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7. Give the file a name.

NOTE: All files names start with WDC_. You can only change the 4 characters that
follow.
8. Tap the Export data button.
If it is not possible to export the selected data, a pop-up message will be shown.

Analyzing QC solutions in other modes

About analyzing QC solutions in other modes

QC solutions may be analyzed in other modes than the Ampoule - QC mode. However,
when this is done, the results must be temperature-corrected manually.

To temperature correct results based on QUALICHECK5+ solutions

NOTE: Results for pH, pCO2 and pO2 must be corrected if the temperature of the
ampoule during measurements was above or below 25 °C.

1. Find the temperature constant (A) in the table.

Radiometer QUALICHECK5+ quality control solutions

Parameter Temperature constants (A)

Level 1 – S7730 Level 2 – S7740 Level 3 – S7750 Level 4 – S7760

pH 0.0018 0.00113 0.000703 0.00163

pCO2 0.00482 0.00231 0.000676 0.00657

pO2 0.00982 0.00986 0.00915 0.0107

2. Find the temperature constant (B) in the table.

Radiometer QUALICHECK5+ quality control solutions

Parameter Temperature constants (B)

Level 1 – S7730 Level 2 – S7740 Level 3 – S7750 Level 4 – S7760

pH 0.0000220 0.0000180 –0.0000260 0.0000209

pCO2 0.0000617 0.0000394 0.0000195 0.000117

pO2 –0.0000327 –0.000115 0.0000177 –0.00000876

3. Use the equations in the table to correct results for parameters that were meas-
ured at temperatures above or below 25 °C.

Parameter Equation for temperature correction

pH pHcorrected to 25 °C = pHmeasured – A (t – 25) – B(t – 25)2

pCO2 (pCO2)corrected to 25 °C = (pCO2)measured × [1 +A (t – 25) + B(t –25)2 ]

pO2 (pO2)corrected to 25 °C = (pO2)measured × [1 +A (t – 25) + B(t –25)2]

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Overview of calibrations

Calibration makes sure that measurement results are accurate and reliable.

The analyzer calibrates most parameters automatically. Only the recommended sensi-
tivity calibration of the oximetry parameters is manual. The calibration adjusts the
optical system of the analyzer to make sure that the results of the oximetry parame-
ters are accurate and reliable.

If necessary, extra calibration can be requested. The calibration materials in the solu-
tion pack are used for this calibration as well as for the automatic calibrations.

Calibration type Calibration identifiers

Automatic calibrations BG pO2

BG, Met pCO2, cGlu, cLac, cCrea*,

cUrea/BUN*

Elec, pH pH, cK+, cNa+, cCa2+, cCl–

Oxi Oximetry parameters

Manual calibration tHb (recommended) Sensitivity calibration of the

oximetry parameters

* Parameters only available on analyzers configured to feature creatinine and

urea/BUN.

Frequency of automatic calibrations

Automatic calibrations are scheduled by default to be done at regular intervals. Auto-

matic calibrations are also done in connection with replacements, troubleshooting and
startup.

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Start of the system-check cycle

System checks

Built-in QC measurements

Sensitivity calibration of pCO2, cGlu, cLac, cCrea*, cUrea/BUN*, and status calibration of
the oximetry parameters

Sensitivity calibration of pH and the electrolytes (cK+, cNa+,cCa2+, cCl–)

Sensitivity calibration of pO2

Calibration of cCrea* and cUrea/BUN*

* Parameters only available on analyzers configured to feature creatinine and

urea/BUN.
Related information
Calibration frequency after a Sensor Cassette SC90 replacement, page 42

To find the status of calibrations

1. Tap Menu > Analyzer status.
2. Tap the Calibrations button.
NOTE: A symbol in the Calibration Type column shows the status of a calibra-
tion.

Symbols that show the calibration status

Symbol Indication

The calibration was completed successfully

An error was found on one or more calibration result

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Symbol Indication

A scheduled calibration is pending. The last calibration was completed successfully.

A scheduled calibration is pending. The last calibration was not completed successfully.

Automatic calibrations

To request an unscheduled calibration from the Analyzer status

screen
1. Tap Menu > Analyzer status.
2. Tap the Calibrations button.
3. Select Calibration as the Calibration Type.
4. Tap the Calibration button.

To request an unscheduled calibration from the menu

Prerequisite(s)
• Make sure that the analyzer is Ready

1. Tap Menu > Start programs > Calibration programs > Calibration.

Manual tHb calibrations

To do a tHb calibration

Required item(s)

A S7770 ctHb calibration ampoule A QUALICHECK Opener/Adapter Gloves

Prerequisite(s)
• The box that contains the S7770 ctHb calibration ampoule has been stored at a
constant temperature (18-32 °C) for 5 hours
• Make sure that the analyzer is Ready
• Make sure that there are no calibration errors on the tHb parameter
• Make sure you wear gloves when performing a QC measurement

WARNING – Risk of infection

Make sure you do not prick or scratch yourself on the Inlet Probe.

1. Remove an ampoule from its box.

2. Close the box.
NOTE: The ampoules are sensitive to light
3. Hold the ampoule between your thumb and first finger and shake it vigorously for
a minimum of 15 seconds.

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4. Hold the ampoule neck-side up between your fingers and tap the top until all solu-
tion collects in the lower part of the ampoule.
5. Put the ampoule in the QUALICHECK Opener/Adapter.

6. Apply pressure in the direction shown, to break off the neck of the ampoule.

7. Put the ampoule in the QUALICHECK Opener/Adapter.

8. Tap Menu > Start programs > Calibration programs > tHb Cal.
9. Scan the barcode on the insert for the S7770 ctHb Calibration Solution.
The analyzer opens the inlet.
10. Turn the QUALICHECK Opener/Adapter with the ampoule so the Radiometer logo
faces upwards.
11. Put the QUALICHECK Opener/Adapter with the ampoule over the inlet gasket.

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12. Push the QUALICHECK Opener/Adapter with the ampoule into the analyzer as far
as it will go and hold it there.

13. Hold the QUALICHECK Opener/Adapter with the ampoule in the pushed-in position
until the analyzer tells you to remove it.

14. When the analyzer tells you to, remove the QUALICHECK Opener/Adapter with the
ampoule.
The analyzer closes the inlet.
NOTE: Sensitivity results between 80 % and 120 % without errors are acceptable.

Calibration results

To find a calibration result

1. Tap Menu > Data logs > Calibration log.
2. Select the calibration.
NOTE: BG = pO2 calibrations; BG, Met = pCO2, cGlu, cLac, cCrea*, cUrea/BUN*
calibrations; Elec, pH = pH, cK+, cNa+, cCa2+, cCl– calibrations and Oxi =
oximetry parameter calibrations.
3. Tap the Result button.
* Parameters only available on analyzers configured to feature creatinine and
urea/BUN.

Identification of calibrations in the Calibration log screen

Calibration identifiers Parameters

BG pO2

BG, Met pCO2, cGlu, cLac, cCrea*, cUrea/BUN*

Met* cCrea*, cUrea/BUN*

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Calibration identifiers Parameters

Elec, pH pH, cK+, cNa+, cCa2+, cCl–

Oxi Oximetry parameters

* Parameters only available on analyzers configured to feature creatinine and

urea/BUN.

Understanding calibration results

Font style Description

Bold black A result from the current calibration

Dark grey A result from a previous calibration. The result is still valid.

Red and Bold red An error occurred. A message attached to the result describes the error.

Symbol Description

? An error occurred or the result is outside a recommended range:

• Drift value is outside the drift tolerance range
• Status value is outside the default range
• Sensitivity value is outside the default range

..... The analyzer could not calculate the value

To see messages on a calibration result

1. Tap Menu > Data logs > Calibration log.
2. Select the calibration.
3. Tap the Result button.
4. Tap the Messages button.

To troubleshoot messages on results

Prerequisite(s)
• You can see the message you want to troubleshoot

1. Select the message.

2. Tap the Troubleshoot button.
3. Follow the instructions on the screen.

Reviewing calibration results

To filter data from the Calibration log

1. Tap Menu > Data logs > Calibration log.
2. Tap the Filter button.

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3. In the Criteria frame, choose an option and follow the steps for it:
Option Steps

To select a time period prior to Tap the number button for the number of
today days you want

To select a start and end date Enter data in the Start date: and End date:
fields
4. Select the next criterion. If necessary, enter or select a value for it.
5. Do step 4 again for each criterion.
6. Tap the Apply button.

To see trends in calibration results

Prerequisite(s)
• You have filtered the calibration results from the Calibration log

1. Tap the Trend button.

2. Select the parameter.
3. Tap the View trend button.

Status in the Calibration log screen

The symbols in the Status column of the Calibration log screen shows the overall
status of each calibration.

Symbol Description

The calibration was successful

An error was found on one or more parameters

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Troubleshooting 7
Troubleshooting - when is it necessary?

Troubleshooting is necessary when the analyzer goes into a Operator Action Needed,
Troubleshooting needed or Intervention Required mode. It may also be neces-
sary to troubleshoot messages in the Analyzer status screen.

About guided troubleshooting

In the troubleshooting modes, Troubleshooting needed and Operator Action

Needed modes, text and video instructions guide you through each troubleshooting
procedure and show you what to do to get out of the troubleshooting mode.

After each troubleshooting procedure, the analyzer makes checks to find out if the
issue has been resolved. If not, a new troubleshooting procedure is shown on the
screen. If the guided troubleshooting procedures do not resolve the issue, the analyzer
will go into the Intervention Required.

To get out of Operator Action Needed mode

1. Follow the text and video instructions on the screen.

To get out of Troubleshooting needed mode

1. Follow the text and video instructions on the screen.

To get out of Intervention Required mode

1. Do the first action shown in the Suggested actions frame.
2. Tap the Test again button.
3. If the analyzer does not go out of Intervention Required mode, do the next
action.
4. Tap the Test again button.
5. If the analyzer does not go out of Intervention Required mode, do steps 3 and 4
again.
6. If none of the actions cause the analyzer to go out of Intervention Required
mode, contact your local Radiometer representative.

Troubleshooting modes - causes

Troubleshooting mode Possible causes

Operator Action Needed • A consumable must be replaced

Troubleshooting needed • Fluid transport errors were found

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Troubleshooting mode Possible causes

Intervention Required • If the troubleshooting procedures in the Troubleshooting

needed mode did not resolve the issue
• All other possible errors

To find and troubleshoot messages in the Analyzer status screen

Prerequisite(s)
• The traffic light in the Analyzer status button is yellow or red

1. Tap Menu > Analyzer status.

2. Tap the button adjacent to a yellow or red traffic light.
3. Choose an option and follow the steps for it.
Option Steps

To troubleshoot a Follow the instructions on the screen

Recommended
action

To troubleshoot To troubleshoot errors in the Built-in QC and

Quality control Ampoule-based QC fields:
messages a) Select the quality control measurement marked by a ,

or symbol.
b) Tap the Result button.
c) Tap the Messages button.
d) Select the message.
e) Tap the Troubleshoot button.
f) Follow the instructions on the screen.
To troubleshoot messages in the QC Messages field:
a) Select the message.
b) Tap the Troubleshoot button.
c) Follow the instructions on the screen.

To troubleshoot To troubleshoot calibrations marked by a , or

Calibrations
symbol.
messages
a) Select the marked calibration.
b) Tap the Result button.
c) Tap the Messages button.
d) Select the message.
e) Tap the Troubleshoot button.
f) Follow the instructions on the screen.
To troubleshoot messages in the Message field:
a) Select the message.
b) Tap the Troubleshoot button.
c) Follow the instructions on the screen.

To troubleshoot a) Select the message.

Consumables or b) Tap the Troubleshoot button.
System
messages c) Follow the instructions on the screen.

Related information
About guided troubleshooting, page 91

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To flush the fluid transport system

Required item(s)

An ABL90 FLEX Flush Device A paper tissue or a cloth Gloves

WARNING – Risk of infection

Make sure that you wear gloves during replacement and maintenance procedures.
NOTE: The analyzer will automatically start the workflow for the flush of the fluid
transport system when necessary.

1. Draw tap water into the Flush Device up to the 2.5 mL mark.
2. Pull the plunger of the Flush Device up to the 5 mL mark to draw air into it.
3. Tap the Press to start video guidance button.
4. Pull off the inlet cover.

5. Tap the Action completed button.

The analyzer opens the inlet.
6. Wait until the Solution Pack is ejected.
7. Remove the Solution Pack.

8. Tap the Action completed button.

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9. Pull out the Inlet Gasket Holder.

10. Tap the Action completed button.

The analyzer closes the inlet.
11. Put a tissue or a cloth under the inlet.
12. Tap the Action completed button.
13. Connect the tip of the Flush Device to the waste connector in the Solution Pack
compartment.

14. Tap the Action completed button.

15. Hold the Flush Device as shown.

16. Inject a very small quantity of air to fill approximately 1 cm of the tube.

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17. Hold the Flush Device as shown.

18. Inject a very small quantity of water to fill approximately 1 cm of the tube.
19. Do steps 15 to 18 again repeatedly to clean the fluid transport system.
20. Tap the Action completed button.
21. Inject water until an unbroken stream of water comes out of the Inlet Probe.
NOTE: The fluid path is flushed, when this is possible.
NOTE: If it is not possible, do steps 15 to 18 and step 21 again.
22. Tap the Action completed button.
23. Disconnect the Flush Device.
24. Remove the tissue or the cloth.
25. Tap the Action completed button.
The analyzer opens the inlet.
26. Put the new Inlet Gasket holder over the slide and insert it. Make sure that the
Inlet Probe is in the center of the gasket and that the Inlet Gasket Holder clicks in
place.

27. Tap the Action completed button.

28. Put your thumbs on the white part of the Solution Pack and push the Solution Pack
into its compartment until it clicks in place. The analyzer closes the inlet.

29. Put on the inlet cover.

30. Tap the Action completed button.

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Operator actions requested in analyzer messages

To request a tubing refill

1. Tap Menu > Start programs > Auxiliary programs > Tubing refill.

To request a liquid sensor adjustment

NOTE: This procedure measures and adjusts the settings of the liquid sensors.

1. Tap Menu > Start programs > Auxiliary programs > Liquid sensor adjust.

To request a pump calibration

NOTE: This procedure makes sure that the pumps in the analyzer operate correctly.

1. Tap Menu > Start programs > Auxiliary programs > Pump calibration.

To request a rinse

NOTE: This procedure starts a rinse process. A rinse is also done after all measure-
ment activities.

1. Tap Menu > Start programs > Auxiliary programs > Rinse.

Automatic and manual flush

When a clot is detected, the automatic clot removal program starts and the analyzer
performs an automatic flush of the sample path.

If you still suspect a clot, you can perform a manual flush of the sample path.

To request an automatic flush of the analyzer

1. Tap Menu > Start programs Auxiliary programs > Automatic flush.
The automatic clot removal program starts.

To perform a manual flush of the analyzer

1. Tap Menu > Start programs Auxiliary programs > Manual flush.
2. Follow the instructions on the screen.

Troubleshooting Analyzer messages

To troubleshoot Analyzer messages

This procedure can be used to find out what operator actions are necessary to trouble-
shoot messages.

1. Note the message number (on the left of the message).

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2. Find the message and operator actions in the Analyzer messages table.
NOTE: The messages in the table are sorted by number.
NOTE: If more operator actions are available, start with the first action listed and
see if this resolves the issue. If not, continue with the next action listed.

Analyzer messages

NOTE: Message 751 is only found in the Activity Log to inform the user about activities
that have taken place. The message is blank (empty) in the database, and when an
activity occurs the actual status information is appended to it resulting in the logged
751-message. If the setting “Log all measurement activities” is enabled in Miscella-
neous Setup, all wet section activities will be logged in the Activity Log as
751-messages.

No. Message Interpretation Action

1 Inconsistent soft- Inconsistent software versions for - Contact Radiometer service represen-
ware versions. different modules. May appear after tative.
Please contact replacing a complete module or as a
service result of an incomplete software
upgrade.

83 Value above refer- The parameter value is above the No action required.
ence range user-defined reference range. This is
only a message, not an error.

84 Value below refer- The parameter value is below the No action required.
ence range user-defined reference range. This is
only a message, not an error.

85 Value below critical The parameter value is below the No action required.
limit user-defined critical limit. This is only a
message, not an error

86 Value above critical The parameter value is above the No action required.
limit user-defined critical limit. This is only a
message, not an error.

89 Measured QC value The measured parameter value is above - Verify the procedure and repeat the
above control the control range. measurement.
range
- See the "Instructions for use".

90 Measured QC value The measured parameter value is below - Verify the procedure and repeat the
below control range the control range. measurement.

- See the "Instructions for use".

93 Value above report- The parameter value is above the report- - Check for and remedy other errors
able range able range. related to the result, system messages
or calibration status.

- Perform QC. If the QC result is

accepted, the blood sample may be
suspected.

- Perform measurement on new blood

sample.

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No. Message Interpretation Action

94 Value below report- The parameter value is below the report- - Check for and remedy other errors
able range able range. related to the result, system messages
or calibration status.

- Perform QC. If the QC result is

accepted, the blood sample may be
suspected.

- Perform a measurement on new blood

sample.

117 LIS/HIS: Invalid The communication configuration or the Check the communication parameters
connection configu- protocol definition was invalid. specified in Communications Setup.
ration

128 LIS/HIS: Failed to The communication hardware was busy - Check that the remote system is
open connection or the remote system did not respond. running, correctly configured and
responding.

- Check communication parameters, e.g.

baud rate, parity, IP address, etc., as
defined in Communication Setup.

- Reboot the analyzer.

129 LIS/HIS: Failed to Messages were queued when the If the problem persists, check the
close connection communication channel was closed. communication hardware. The remote
Results and other messages sent by the system may lack buffer capacity.
analyzer to a remote system may be
lost.

131 LIS/HIS: Failed to A communication error occurred while - Check that the remote system is
send packet sending a message. The message was running and responding.
not sent.
- Check the communication hardware,
including cables.

- Repeat sending.

132 LIS/HIS: Failed to An error occurred while receiving a - Check that protocol types are correctly
receive packet message. The analyzer was not able to configured on both the analyzer and the
recognize the received massage. remote system.

- Contact Radiometer service represen-

tative.

133 LIS/HIS: Connec- A previously established LIS/HIS - Check that the remote system is
tion lost connection has been lost. running and responding.

- Check cables.

134 LIS/HIS: Connec- The connection was successfully estab- No action required. For information only.
tion established lished.

165 LIS/HIS: High-level An error occurred while formatting a Check protocol configurations. Contact
protocol could not message. Radiometer service representative.
generate high-level
packet

166 LIS/HIS: General An internal error occurred in the LIS/HIS Contact Radiometer service representa-
communication communication module. tive if the problem persists.
error

167 LIS/HIS: High-level An error occurred while parsing (inter- Check protocol configurations. Contact
protocol received preting) a message. Radiometer service representative.
packet in wrong
format

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No. Message Interpretation Action

200 Operator msg: This is only a message. An operator has No action required.
entered a note in the log.

201 Westgard Rule Measured parameter value is outside the - Verify procedure and repeat measure-
(1.2s) violation mean +/- 2 SD range. ment.

- Check Replacement Status for pending

replacements.

- See the "Instructions for use" for

detailed evaluation procedure.

202 Westgard Rule Measured parameter value is outside the - Verify procedure and repeat measure-
(1.3s) violation mean +/- 3 SD range. ment.

- Check Replacement Status for pending

replacements including elctrodes.

- See the "Instructions for use" for

detailed evaluation procedure.

203 Westgard Rule Two consecutive measurements are - Verify procedure and repeat measure-
(2.2s) violation outside the mean +/- 2 SD range on the ment.
same side of the mean. This may indi-
cate a shift. - Check Replacement Status for pending
replacements including electrodes.

- See the "Instructions for use" for

detailed evaluation procedure.

204 Westgard Rule (R. The difference between two consecutive - Verify procedure and repeat measure-
4s) violation measurements exceeds 4 SD. This may ment.
indicate an inconsistency in your proce-
dure or an unstable analyzer. - Check Replacement Status for pending
electrode replacements.

- See the "Instructions for use" for

detailed evaluation procedure.

205 Westgard Rule Four consecutive measurements are - Check for excessive electrode sensor
(4.1s) violation outside the mean +/- 1 SD range on the calibration drift.
same side of the mean. A trend or shift
is indicated. Patient results should be - Check Replacement Status for pending
considered unreliable until the problem electrode replacements.
is remedied.
- See the "Instructions for use" for eval-
uation procedure.

206 Westgard Rule Ten consecutive measurements are on - Check the electrode drift during last
(10.x) violation the same side of the mean. A trend or calibration.
shift is indicated. Patient results should
be considered unreliable until the - Check Replacement Status for pending
problem is remedied. electrode replacements.

- See the "Instructions for use" for eval-

uation procedure.

207 Calibration One or more scheduled calibrations are Check the Calibration Status and
schedule overdue. perform any pending calibrations.
reminder(s)
present

208 Quality control One or more scheduled QC measure- Check the Quality Control Status and
schedule ments are overdue. perform the pending quality control.
reminder(s)
present

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No. Message Interpretation Action

209 Replacement One or more scheduled replacements Check the Replacement Status and
schedule are overdue. perform any pending replacement
reminder(s) actions.
present

210 Calibration error(s) An error registered on one or more Check Calibration Status for errors in
present parameters during the last calibration. latest calibration results for the given
parameter. View calibration error
messages and take required corrective
action.

211 Quality control One or more errors were registered Check Quality Control Status for errors.
error(s) present during last QC measurement on one of View QC error messages and take
the installed QC levels. required corrective action.

212 System One or more systems errors are present. Check the System Messages Status for
message(s) errors. Take corrective required action.
present

213 Automatic backup An error occurred during the scheduled - Check Automatic Backup Setup.
failed data backup.
- Check network and servers used for
the backup.

- Contact your IT engineer.

214 Automatic backup The scheduled automatic backup was No action required.
succeeded completed successfully.

216 General printer A printer problem has occurred, e.g. the - Check printer paper. Clear any jam.
error paper is jammed
- Power down and restart the analyzer.

- Contact Radiometer service represen-

tative.

217 Replacement: The message is used in the Activity Log No action required.
to indicate a performed replacement.

290 Warning: SHb FSHb detected in the range of 1-10 %. No action required. For information only.
detected

291 SHb too high Detected FSHb is greater than 10%. - Repeat the measurement.
Measurement accuracy is affected.

292 Turbidity too high Turbidity is greater than 5 %: too high - Hyperlipemic sample; decrease the
for reliable measurements. lipemic content by e.g. centrifuge or
extraction.

- Perform the measurement on a blood

sample from a healthy donor.

- Contact Radiometer service represen-

tative.

293 Oxi compensated OXI parameters have been HbF compen- No action required. For information only.
for HbF sated. Parameter FHbF may be shown or
not shown.

329 QC expiration date The quality control measurement was - Discontinue the use of the lot and set
exceeded performed on an expired control solu- up a valid lot for the control solution.
tion.

331 No sample No sample detected in sensor. Measure- - Ensure that adequate sample volume is
detected during ment is aborted. used.
sample aspiration
- Check the sample for clots.

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No. Message Interpretation Action

357 Temp. error: Temperature in the barometer on the - Ensure that the ambient temperature is
Barometer Analyzer Control is outside 37 +/- 1.0 between 15 and 32 °C.
°C.
- If the system has just performed a cold
start, wait for the error to disappear.

- Shield the analyzer from direct sunlight

and other heat sources.

- Contact Radiometer service represen-

tative.

375 Calibration status The status value is outside the range for - Check for and remedy any system
out of limits the given parameter. messages.

- Repeat the calibration.

- Check solution pack status and

replace, if necessary.

- Check sensor cassette status and

replace, if necessary.

376 Calibration Drift 1 The Drift 1 value exceeds the tolerance. - Check for and remedy any system
out of range messages.

- Repeat the calibration.

- Check solution pack status and

replace, if necessary.

- Check sensor cassette status and

replace, if necessary.

377 Calibration Drift 2 The Drift 2 value exceeds the tolerance. - Check for and remedy any system
out of range messages.

- Repeat the calibration.

- Check solution pack status and

replace, if necessary.

- Check sensor cassette status and

replace, if necessary.

378 Calibration sensi- The sensitivity value is out of range for - Check for and remedy any system
tivity out of range the given parameter. messages.

- Repeat the calibration.

- Check solution pack status and

replace, if necessary.

- Check sensor cassette status and

replace, if necessary.

379 Calibration An electrode response fault occurred - Check for and remedy any system
unstable (response during calibration. messages.
fault)
- Repeat the calibration.

- Check solution pack status and

replace, if necessary.

- Check sensor cassette status and

replace, if necessary.

443 Ca(7.4) not usable cCa2+ at a pH of 7.4 is not usable as the No action required.
actual pH is outside the 7.2-7.6 range.

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No. Message Interpretation Action

452 Interference during Interference was detected during meas- Check the patient record for medication
measurement urement. containing possible interfering
substances.

484 Today is last day in After the current day, quality control Print the QC statistics if a copy is
stat. month - statistics obtained over the month will required.
remember to print be deleted and new statistics started.
QC statistics

487 A new statistical A new statistical month has begun. Make a WDC report disk.
month has begun -
remember to
export WDC data

494 Bilirubin too high Detected bilirubin concentration, No action required.

ctBil(blood), is greater than 2000
µmol/L. The corresponding plasma bilir-
ubin concentration can be calculated as
follows: ctBil(blood) = (1-Hct) ×
ctBil(plasma).

508 Liquid transport Liquid transport of Rinse failed - Check solution pack or sensor cassette
error during rinse status and replace, if necessary.

512 Temperature error The temperature was outside the - Ensure that the ambient temperature is
required range during measurement or between 15 and 32 °C.
calibration. All results are marked with
"?". - If the analyzer has recently performed
a cold start, wait for the temperature
error to disappear.

- If the solution pack or sensor cassette

has recently been replaced, wait for the
temperature error to disappear.

- Shield analyzer from direct sunlight or

heat sources.

- Contact Radiometer service represen-

tative.

521 Inhomogeneous Air bubbles were detected in the sample. - Repeat the measurement.
sample Results may have "?".

522 Calibration error One or more calibration values are erro- - Check for and remedy any system
neous. messages.

- Repeat the calibration.

- Check solution pack status and

replace, if necessary.

- Check sensor cassette status and

replace, if necessary.

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No. Message Interpretation Action

523 Calibration drift out Calibration drift exceeds defined limits. - Check for and remedy any System
of range Messages.

- Perform any pending replacements

including electrodes.

- Check that electrodes are properly

installed.

- Verify that proper solutions and gases

are used.

- Perform the Electrode Troubleshooting

procedure.

529 Inlet LS failed to Inlet liquid sensor failed to calibrate. - Repeat the liquid sensor calibration.
calibrate
- Contact Radiometer service represen-
tative.

531 Sensors LS failed Liquid sensor near the sensor cassette - Repeat the liquid sensor calibration.
to calibrate failed to calibrate.
- Check solution pack status and replace
if necessary.

- Contact Radiometer service represen-

tative.

537 OXI LS failed to OXI module liquid sensor failed to cali- - Repeat the liquid sensor calibration.
calibrate brate.
- Check solution pack status and
replace, if necessary.

- Contact Radiometer service represen-

tative.

581 OXI spectrum Spectrum deviates from the expected - Check the patient record for medica-
mismatch blood or QC spectrum. Measurement tion containing possible interfering
may be unrealiable. substances.

- Start a calibration.

- Contact Radiometer service represen-

tative.

582 tHb calibration tHb calibration failed. - Perform a calibration.

cuvette factor
outside limits - Repeat the tHb calibration.

- Contact Radiometer service represen-

tative.

584 tHb calibration tHb calibration failed. - Perform a calibration.

wavelength outside
limits - Repeat the tHb calibration.

- Contact Radiometer service represen-

tative.

588 Measured QC value The parameter value is below the lower - Verify the procedure and repeat the
lower than statis- limit of the operator-defined statistical measurement.
tical range range. Measurement is not included in
statistics. - See the "Instructions for use" for
details on the evaluation of the results.

589 Measured QC value The parameter value is above the upper - Verify the procedure and repeat the
higher than statis- limit of the operator-defined statistical measurement.
tical range range. Measurement not included into
statistics. - See the "Instructions for use" for
details on the evaluation of the results.

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No. Message Interpretation Action

593 Insufficient sample Sample volume is too small for the - Repeat the measurement, ensuring
selected measuring mode. Affected sufficient sample volume.
parameters will be marked with "?".
- Contact Radiometer service represen-
tative.

595 Liquid sensor cali- One or more of the liquid sensors failed - Repeat the liquid sensor calibration.
bration error calibration.
- Check solution pack status and
replace, if necessary.

- Contact Radiometer service represen-

tative.

606 Cal expired (pH) Too long time passed since the last Perform a calibration.
successful calibration of the parameter.
Parameter measurement values are
reported as ".....".

608 Cal expired (pCO2) Too long time passed since the last Perform a calibration.
successful calibration of the parameter.
Parameter measurement values are
reported as ".....".

609 Cal expired (pO2) Too long time passed since the last Perform a calibration.
successful calibration of the parameter.
Parameter measurement values are
reported as ".....".

610 Cal expired (K) Too long time passed since the last Perform a calibration.
successful calibration of the parameter.
Parameter measurement values are
reported as ".....".

611 Cal expired (Na) Too long time passed since the last Perform a calibration.
successful calibration of the parameter.
Parameter measurement values are
reported as ".....".

612 Cal expired (Ca) Too long time passed since the last Perform a calibration.
successful calibration of the parameter.
Parameter measurement values are
reported as ".....".

613 Cal expired (Cl) Too long time passed since the last Perform a calibration.
successful calibration of the parameter.
Parameter measurement values are
reported as ".....".

614 Cal expired (Glu) Too long time passed since the last Perform a calibration.
successful calibration of the parameter.
Parameter measurement values are
reported as ".....".

615 Cal expired (Lac) Too long time passed since the last Perform a calibration.
successful calibration of the parameter.
Parameter measurement values are
reported as ".....".

616 Cal expired (OXI) Too long time elapsed since the last Perform a calibration.
successful calibration of the parameter.
Parameter measurement values are
reported as ".....".

641 ABL/DMS PC The analyzer was restarted from power No action required. For information only.
restarted off.

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No. Message Interpretation Action

642 ABL/DMS PC Added by DMS PC when connection to - No action required.

connected to wet the wet section is obtained.
section

643 ABL/DMS PC The connection from the DMS PC to the - Shut down and restart the analyzer.
disconnected from wet section is lost.
wet section - Contact Radiometer service represen-
tative.

648 Calibration failed or The last calibration was aborted or not - Check solution pack status and
not accepted accepted. replace, if necessary.

- Check sensor cassette status and

replace, if necessary.

- Check for and remedy system

messages.

- Repeat the calibration.

662 Barometer out of Measured barometer value is outside the - Contact Radiometer service represen-
range measuring range: 60-106.7 kPa. tative.

669 QC value outside Measured parameter value is outside - Verify the procedure and repeat meas-
control range control range. urement.

- Refer to Quality Control Systems Refer-

ence Manual.

679 Barometer error The measured parameter may be unreli- Contact Radiometer service representa-
able due to barometer error. tive.

682 OXI module not The OXI module is not responding due to - Shut down the analyzer, using the
active an internal communication problem, or Temporary Shutdown function; then
the software configuration does not restart it.
match the analyzer type.
- Contact Radiometer service represen-
tative.

688 ctHb/ceHb too low ctHb < 1 mmol/L, or ceHb < 0.75 If Oxi derivates are wanted, elevate tHb
for OXI calculation mmol/L. If ctHb is too low, FHHb, and/or sO2.
FO2Hb, FCOHb and FMetHb are not
calculated. If ceHb = cHHb + cO2Hb is
too low, sO2 is not calculated.

692 ABL not connected The analyzer is not connected to RADI- - Contact your RADIANCE/IT engineer.
to RADIANCE ANCE.
- Check RADIANCE Communication
Setup including TCP/IP address, port no.
and password.

- Check that RADIANCE is responding.

- Check network connections.

693 ABL not connected The analyzer was refused connection to Enter the correct password in the
to RADIANCE - RADIANCE due to incorrect password. analyzer's RADIANCE Communication
incorrect password Setup.

694 ABL connected to The analyzer is connected to RADIANCE. No action required.

RADIANCE

695 ABL disconnected The analyzer was disconnected from No action required.
from RADIANCE RADIANCE.

696 ABL<>RADIANCE Communication error between the Contact Radiometer service representa-
communication analyzer and RADIANCE. tive.
error

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No. Message Interpretation Action

699 Built-in QC meas- The analyzer was set up to perform Check Calibration Status and remedy
urement started built-in QC measurements in case of any reported calibration errors.
due to calibration calibration errors.
error

700 Scheduled built-in Last calibration contained an error, and Check Calibration Status and remedy
QC not run due to the analyzer was set up to suspend calibration errors.
errors in last cali- built-in QC measurements in case of
bration calibration errors.

703 QC expired QC measurement is overdue (corrective Perform a quality control measurement.

action "Lock analyzer" has been selected
in the Setup program: Corrective
Actions).

704 Built-in QC meas- The scheduled QC measurement was not No action required.
urement is accepted; the measurement was
repeated repeated as requested in the Setup
program: Corrective Actions.

705 Built-in QC meas- The scheduled QC measurement was not No action required.
urement is accepted; the measurement was
repeated twice repeated twice as requested in the Setup
program: Corrective Actions.

707 Replacement(s) Replacement is overdue by 10 % - Check Replacement Status and replace

overdue by 10 %. (corrective action "Lock analyzer" was as required.
Analyzer locked. selected in the Setup program: Correc-
tive Actions). When the analyzer is - Unlock analyzer in the Miscellaneous
locked, scheduled calibrations are Setup program.
performed, but no patient samples or QC
measurements are allowed.

708 Corrective action Scheduled built-in QC measurement was Insert a new solution pack.
not possible due to requested, but the solution pack was
empty solution empty.
pack

712 FHbF measurement Composition of the blood sample makes If FHbF is wanted change sample
not possible FHbF measurement too inaccurate, but composition. For example, elevate sO2
OXI parameters are compensated for and tHb.
HbF. See explanation in the "Instructions
for use".

713 ctBil measurement Blood sample ctHb is so high that hardly If ctBil is wanted, lower the ctHb value.
not possible any plasma is left to measure plasma
biliribin on. ctHb > 14.56mmol/L.

734 General WSM The data management system estab- - Wait a few minutes for the connection
exception lishes connection to the analyzing unit, to establish.
or the connection is lost.
- Restart the analyzer.

- If the error persists, contact Radio-

meter service representative.

745 Low disk space Free disk space is low. Move archive files to another storage
device.

766 ABL not connected The analyzer has been refused connec- Contact RADIANCE/IT engineer or Radio-
to RADIANCE - no tion to RADIANCE because there is no meter service representative.
RADIANCE connec- connection license available on RADI-
tion license ANCE.

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No. Message Interpretation Action

767 ABL not connected The analyzer has been refused connec- Contact RADIANCE/IT engineer or Radio-
to RADIANCE - ABL tion to RADIANCE because the ABL Stat- meter service representative.
StatLink version Link version is higher than the RADI-
too high ANCE StatLink version.

768 ABL not connected The analyzer has been refused connec- Contact RADIANCE/IT engineer or Radio-
to RADIANCE - ABL tion to RADIANCE because the ABL Stat- meter service representative.
StatLink version Link version is lower than the RADIANCE
too low StatLink version.

769 ABL<>RADIANCE Communication error between the Contact RADIANCE/IT engineer or Radio-
communication analyzer and RADIANCE. meter service representative.
error - XML packet
could not be
parsed

770 Failed to restore The setup could not be restored. - Download the setup data from another
Custom Setup floppy disk, hard disk or network drive.

- Contact Radiometer service represen-

tative if the error persists.

771 Succeeded to Restoring of setup is completed. No action required.

restore Custom
Setup

772 Operator Activity: Operator activity logged by operator. No action required.

773 Remote operator A remote operator has logged on the No action required.
logged on with analyzer.
operator:

774 Remote operator An operator, remotely logged on has No action required.

logged off with logged off, or has been logged off by a
operator: local operator.

775 Failed to restore Restoring analyzer setup to default Contact Radiometer service representa-
Default Setup values has failed. tive.

776 Succeeded to Restoring setup to default values is No action required.

restore Default completed.
Setup

780 RADIANCE commu- RADIANCE communication has been No action required. For information only.
nication enabled enabled as part of the RADIANCE
Connection Setup.

781 RADIANCE commu- RADIANCE communication has been No action required. For information only.
nication disabled disabled as part of the RADIANCE
Connection Setup.

782 RADIANCE output The output queue was cleared in the No action required. For information only.
queue cleared RADIANCE Connection Setup.

783 Automatic backup Automatic backup (selected in Disk No action required. For information only.
started Functions Setup) has started.

785 Automatic Automatic archiving (selected in Disk No action required. For information only.
archiving started Functions Setup) has started.

786 Automatic Automatic archiving (selected in Disk No action required. For information only.
archiving Functions Setup) completed successfully.
completed

787 Export of data logs Export of data logs was started by the No action required. For information only.
started operator.

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No. Message Interpretation Action

798 Operator logged on Operator logged on successfully. No action required. For information only.

799 Operator logged off Operator logged off. No action required. For information only.

800 Logon attempt Operator tried to log on but did not Provide a valid password to log on.
failed provide a valid password.

810 pH locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

811 pCO2 locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

812 pO2 locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

813 K locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

814 Na locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

815 Cl locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

816 Ca locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

818 Glu locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

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No. Message Interpretation Action

819 Lac locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

820 tHb locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

821 MetHb locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

822 COHb locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

823 HHb locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

824 O2Hb locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

825 sO2 locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

826 HbF locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

827 tBil locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

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No. Message Interpretation Action

828 Urea/BUN locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log. When a parameter is
locked, presumably due to problems
with QC, the parameter is repressed in
patient results.

830 Crea locked The parameter has been locked by a Await corrective actions initiated by the
RADIANCE operator, as reflected in the RADIANCE operator.
Activity Log.

When a parameter is locked, presumably

due to problems with QC, the parameter
is repressed in patient results.

831 pH unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

832 pCO2 unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

833 pO2 unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

834 K unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

835 Na unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

836 Cl unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

837 Ca unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

839 Glu unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

840 Lac unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

841 tHb unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

842 MetHb unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

843 COHb unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

844 HHb unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

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No. Message Interpretation Action

845 O2Hb unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

846 sO2 unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

847 HbF unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

848 tBil unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

849 Urea/BUN unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

851 Crea unlocked The message is used in the Activity Log No action required. For information only.
to indicate that a previously locked
parameter has been unlocked.

852 RADIANCE: Message from RADIANCE. No action required. For information only.

855 Base Excess out of Base Excess exceeds the +/- 30 mmol/L For information only. No analyzer error
range range. was detected.

875 Sample aged The specified limit for sample age has Draw and analyze new sample.
been exceeded.

885 Cyclic QC schedule The cyclic QC schedule has been reset No action required. For information only.
reset from RADI- and all related reminders have been
ANCE removed as a result of a RADIANCE
command.

886 LIS/HIS: No valid A file with a valid Device ID does not Contact Radiometer service representa-
POCT1A DML exist. A valid Device ID is needed in tive to obtain a Device ID file.
Device ID file order to use the POCT1A DML protocol.

963 Leak current in Leak currents were detected during - Replace inlet connector gasket, sensor
analyzer detected system calibration and may distort cassette or solution pack.
measuring results.
- Contact Radiometer service represen-
tative.

964 Leak current in Leak currents were detected during - Replace solution pack.
relation to solution system calibration and may distort
pack detected measuring results. - Contact Radiometer service represen-
tative.

970 Replace solution This message is shown when the solu- - Replace solution pack.
pack tion pack needs to be replaced. The
analyzer will enter "Operator-interven-
tion required".

971 Replace sensor This message is shown when the sensor - Replace sensor cassette.
cassette cassette needs to be replaced. The
analyzer will enter "Operator-interven-
tion required".

973 Printer paper must No more paper in printer. Insert new printer paper.
be replaced

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No. Message Interpretation Action

978 Flow selector cali- Shown in the Activity Log when "Oper- The analyzer will automatically enter
bration error ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

979 Inhomogeneous Shown in the Activity Log when "Oper- The analyzer will automatically enter
rinse solution ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

983 Inhomogeneous cal Shown in the Activity Log when "Oper- The analyzer will automatically enter
3 solution ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

984 The analyzer could Shown in the Activity Log when "Oper- The analyzer will automatically enter
not aspirate homo- ator-intervention required" has been "Operator-intervention required". Follow
geneous calibration entered due to this reason. the instructions shown on the screen.
solution

1000 Number of pO2 Can be shown on a result if unable to - Restart the analyzer.
hardware data fail calculate oxygen due to an unexpected
system error. - Perform a calibration.

- Contact Radiometer service represen-

tative.

1001 Timeout while Can be shown on a result if unable to - Restart the analyzer.
waiting for pO2 calculate oxygen due to an unexpected
hardware data system error. - Perform a calibration.

- Contact Radiometer service represen-

tative.

1002 pO2 dark data is Can be shown on a result if unable to - Restart the analyzer.
out of range calculate oxygen due to an unexpected
system error. - Perform a calibration.

- Contact Radiometer service represen-

tative.

1004 Unable to calculate Can be shown on a result if unable to - Restart the analyzer.
oxygen parameter calculate oxygen due to an unexpected
system error. - Perform a calibration.

- Contact Radiometer service represen-

tative.

1005 Unable to calculate Can be shown on a result if unable to - Restart the analyzer.
oxygen parameter calculate oxygen due to an unexpected
system error. - Perform a calibration.

- Contact Radiometer service represen-

tative.

1006 Unable to calculate Can be shown on a result if unable to - Restart the analyzer.
oxygen parameter calculate oxygen due to an unexpected
system error. - Perform a calibration.

- Contact Radiometer service represen-

tative.

1007 Missing oxygen No calibration data exists for oxygen. Perform a calibration.
calibration

1008 Unable to calculate Can be shown on a result if unable to - Restart the analyzer.
oxygen parameter calculate oxygen due to an unexpected
system error. - Perform a calibration.

- Contact Radiometer service represen-

tative.

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No. Message Interpretation Action

1009 Unable to calculate Can be shown on a result if unable to - Restart the analyzer.
oxygen parameter calculate oxygen due to an unexpected
system error. - Perform a calibration.

- Contact Radiometer service represen-

tative.

1010 Oxi data collection Oxi hardware problem - Restart the analyzer.
error
- Perform a calibration.

- Contact Radiometer service represen-

tative.

1011 Oxi has no Blank Missing Blank Cal. Not necessarily a - Perform a calibration.
Cal hardware error.
- Restart the analyzer.

- Contact Radiometer service represen-

tative.

1012 Oxi has no sample The system has not made a sample - Repeat the measurement.
spectrum measurement yet, or there is a hardware
problem. - Restart the analyzer.

- Contact Radiometer service represen-

tative.

1013 Oxi data collection Oxi hardware error - Restart the analyzer.
error
- Perform a calibration.

- Contact Radiometer service represen-

tative.

1014 Oxi Blank Cal. The spectrometer received too high light - Check solution pack. During Oxi Blank
intensity too high intensity during Blank Cal. calibration, the cuvette must be filled
with liquid.

- Perform a calibration.

- Restart the analyzer.

- Contact Radiometer service represen-

tative.

1015 Oxi sample inten- The spectrometer received too high light - Check solution pack. During Oxi Blank
sity too high intensity during sample measurement. calibration, the cuvette must be filled
with liquid.

- Perform a calibration.

- Repeat the sample measurement.

1016 Oxi Blank Cal. The spectrometer received too low light - Perform a calibration.
intensity too low intensity during Blank Cal.
- Restart the analyzer.

- Contact Radiometer service represen-

tative.

1017 Oxi sample inten- The spectrometer received too low light - Restart the analyzer.
sity too low intensity during sample measurement.
- Perform a calibration.

- Contact Radiometer service represen-

tative.

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No. Message Interpretation Action

1018 Oxi electronic Oxi hardware problem. - Restart the analyzer.

adjustment error
- Perform a calibration.

- Contact Radiometer service represen-

tative.

1019 Oxi Blank Cal. Peak value of Blank Cal. spectrum inten- - Check solution pack. The cuvette must
outside limits sity is outside acceptance limits. be filled with liquid during Blank calibra-
tion.

- Perform a calibration.

- Restart the analyzer.

- Contact Radiometer service represen-

tative.

1020 Oxi neon intensity Oxi hardware problem. - Restart the analyzer.
outside limits
- Perform a calibration.

- Contact Radiometer service represen-

tative.

1021 Oxi neon correction Oxi hardware problem. - Restart the analyzer.
outside limits
- Contact Radiometer service represen-
tative.

1022 Oxi background Oxi hardware problem. - Restart the analyzer.

correction outside
limits - Contact Radiometer service represen-
tative.

1023 Oxi spectrometer Oxi hardware problem. - Restart the analyzer.

memory read
problem - Contact Radiometer service represen-
tative.

1024 Oxi spectrometer Oxi hardware problem. - Restart the analyzer.

memory write
problem - Contact Radiometer service represen-
tative.

1025 Oxi hemolyzer Oxi hardware problem. - Restart the analyzer

tuning problem
- Contact Radiometer service represen-
tative.

1026 Oxi hemolyzer Oxi hardware problem. - Restart the analyzer.

frequency problem
- Contact Radiometer service represen-
tative.

1027 Oxi hemolyzer Oxi hardware problem. - Restart the analyzer.

temperature devia-
tion too high - Contact Radiometer service represen-
tative.

1028 Oxi neon voltage Oxi hardware problem. - Restart the analyzer.
outside limits
- Contact Radiometer service represen-
tative.

1029 Oxi light source Oxi hardware problem. - Restart the analyzer.
voltage outside
limits - Contact Radiometer service represen-
tative.

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No. Message Interpretation Action

1030 Oxi hemolyzer Oxi hardware problem. - Restart the analyzer.

voltage outside
limits - Contact Radiometer service represen-
tative.

1031 Oxi initialization in Oxi initialization in progress. - Please wait up to 50 minutes before
progress restarting the analyzer.

- Restart the analyzer.

- Contact Radiometer service represen-

tative.

1032 Oxi data collection Oxi hardware problem. - Restart the analyzer.
problem
- Contact Radiometer service represen-
tative.

1033 Oxi task was not Internal software problem. - Restart the analyzer.
finished
- Contact Radiometer service represen-
tative.

1034 Oxi hardware An Oxi hardware problem has occurred. - Restart the analyzer.
problem
- Perform a calibration.

- Contact Radiometer service represen-

tative.

1045 Unable to read Unable to read information stored on - Reinstall the solution pack and sensor
consumable infor- either sensor cassette or solution pack. cassette.
mation
- Restart the analyzer.

- Contact Radiometer service represen-

tative.

1061 Pressure test flow The sample transport through the The analyzer will automatically enter
error analyzer is hindered. "Operator-intervention required". Follow
the instructions shown on the screen.

1062 Pressure test pres- A leak has been found in the solution The analyzer will automatically enter
sure error transport. "Operator-intervention required". Follow
the instructions shown on the screen.

1063 Pressure test A leak has been found in the solution The analyzer will automatically enter
vacuum error transport. "Operator-intervention required". Follow
the instructions shown on the screen.

1064 Temperature in Hardware temperature error. - Ensure that the ambient temperature is
sensor cassette top between 15 and 32 °C.
out of range
- If the system has just performed a cold
start, wait for the error to disappear.

- Shield the analyzer from direct sunlight

and other heat sources.

- Contact Radiometer service represen-

tative.

996-686C 115
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No. Message Interpretation Action

1065 Temperature in Hardware temperature error. - Ensure that the ambient temperature is
sensor cassette between 15 and 32 °C.
bottom out of
range - If the system has just performed a cold
start, wait for the error to disappear.

- Shield the analyzer from direct sunlight

and other heat sources.

- Contact Radiometer service represen-

tative.

1066 Temperature in Hardware temperature error. - Ensure that the ambient temperature is
sensor cassette between 15 and 32 °C.
substrate out of
range - If the system has just performed a cold
start, wait for the error to disappear.

- Shield the analyzer from direct sunlight

and other heat sources.

- Contact Radiometer service represen-

tative.

1069 Temperature in Oxi Hardware temperature error. - Ensure that the ambient temperature is
cuvette out of between 15 and 32 °C.
range
- If the system has just performed a cold
start, wait for the error to disappear.

- Shield the analyzer from direct sunlight

and other heat sources.

- Contact Radiometer service represen-

tative.

1070 Sensor response Unstable signal from sensor. Repeat measurement

error

1071 Temperature in Oxi Hardware temperature error. - Ensure that the ambient temperature is
spectrometer out between 15 and 32 °C.
of range
- If the system has just performed a cold
start, wait for the error to disappear.

- Shield the analyzer from direct sunlight

and other heat sources.

- Contact Radiometer service represen-

tative.

1079 Sensor impedance Sensor impedance error - Perform calibration

error
- Replace sensor casette

1081 Inhomogeneous Shown in the Activity Log when "Oper- The analyzer will automatically enter
rinse solution ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1083 Inhomogeneous cal Shown in the Activity Log when "Oper- The analyzer will automatically enter
2 solution ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1084 Inhomogeneous cal Shown in the Activity Log when "Oper- The analyzer will automatically enter
3 solution ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

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No. Message Interpretation Action

1085 Inhomogeneous Bubbles were detected in the QC1 solu- - Perform a refill from the auxiliary
QC1 solution tion. program.

- Replace the solution pack.

1086 Inhomogeneous Bubbles were detected in the QC2 solu- - Perform a refill from the auxiliary
QC2 solution tion. program.

- Replace the solution pack.

1087 Inhomogeneous Bubbles were detected in the QC3 solu- - Perform a refill from the auxiliary
QC3 solution tion. program.

- Replace the solution pack.

1089 Inhomogeneous Shown in the Activity Log when "Oper- The analyzer will automatically enter
gas ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1090 No rinse solution Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1092 No cal 2 solution Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1093 No cal 3 solution Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1094 No QC1 solution Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1095 No QC2 solution Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1096 No QC3 solution Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1098 No gas Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1099 Pump calibration Shown in the Activity Log when "Oper- The analyzer will automatically enter
error ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1100 Outlet LS not Shown in the Activity Log when "Oper- The analyzer will automatically enter
empty during pump ator-intervention required" has been "Operator-intervention required". Follow
calibration entered due to this reason. the instructions shown on the screen.

1101 Outlet LS not full Shown in the Activity Log when "Oper- The analyzer will automatically enter
during pump cali- ator-intervention required" has been "Operator-intervention required". Follow
bration entered due to this reason. the instructions shown on the screen.

1111 Inhomogeneous air Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1112 LS inlet not empty Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

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No. Message Interpretation Action

1113 LS sensors not Shown in the Activity Log when "Oper- The analyzer will automatically enter
empty ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1114 LS outlet not Shown in the Activity Log when "Oper- The analyzer will automatically enter
empty ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1115 Ws communication Internal communication error. - Restart the analyzer.

error: wrong
message format - Contact Radiometer service represen-
tative.

1116 Ws communication Internal communication error. - Restart the analyzer.

error: keep alive
timeout - Contact Radiometer service represen-
tative.

1117 Oxi spectrometer A large deviation in temperature has - Perform a calibration

temperature drift been observed. This is probably due to a
change in the ambient environment.

1120 Sensor replace- This message is shown in the Activity No action required. For information only.
ment successful Log following a successful replacement
of the sensor cassette.

1121 The port did not This message is shown in the Activity - Reinstall the sensor cassette.
open during sensor Log after a failed sensor cassette
replacement replacement. - Restart the analyzer.

- Contact Radiometer service represen-

tative.

1123 The sensor chip This message is shown in the Activity - Reinstall the sensor cassette.
data could not be Log after a failed sensor cassette
read or written replacement. - Restart the analyzer.
during replacement
- Contact Radiometer service represen-
tative.

1124 An unregistered This message is shown in the Activity No action required. For information only.
sensor was Log after a sensor cassette replacement,
installed during that did not identify a previously condi-
replacement tioned cassette.

1125 An unregistered This message is shown in the Activity No action required. For information only.
and used sensor Log after a sensor cassette replacement.
was installed It informs that the sensor cassette
during replacement installed is already used and no informa-
tion exists about the conditioning hereof.

1126 A registered sensor This message is shown in the Activity No action required. For information only.
had been used Log after a sensor cassette replacement.
before installation It informs that the sensor cassette
installed has been used before.

1134 The chip informa- This message is shown in the Activity - Reinstall the solution pack.
tion for the solution Log after a failed solution pack replace-
pack cannot be ment. - Restart the analyzer.
read or written
- Contact Radiometer service represen-
tative.

1135 The solution pack This message is shown in the Activity - Reinstall the solution pack.
has been used Log after a failed solution pack replace-
before ment.

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No. Message Interpretation Action

1140 The solution pack This message is shown in the Activity - Reinstall the solution pack.
has used the Log after a failed solution pack replace-
maximum number ment.
of measurements
at installation

1142 The printer door is Printer door open. - Ensure that the printer paper is prop-
open. Printing not erly installed.
possible
- Close the printer door.

1143 Internal printer is Printer hardware error. - Ensure that the printer paper is prop-
offline. Printing not erly installed.
possible
- Close the printer door.

1144 Check that printer Printer hardware error. - Ensure that the printer paper is prop-
door is closed and erly installed.
that paper is
present - Close the printer door.

1145 A printer error has Printer hardware error. - Ensure that the printer paper is prop-
occurred. Call erly installed.
service technician
- Close the printer door.

1146 Printer paper This message is shown in the Activity No action required. For information only.
replaced Log after replacement of printer paper.

1147 Inlet opened during Shown in the Activity Log when "Oper- The analyzer will automatically enter
rinse ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1148 Inlet open during Shown in the Activity Log when "Oper- The analyzer will automatically enter
calibration ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1149 Inlet open during Shown in the Activity Log when "Oper- The analyzer will automatically enter
wet section activity ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1150 Inlet closed without This message is shown in the Activity No action required. For information only.
aspirating sample Log when a measurement has been
cancelled due to inlet being closed
before aspiration could be completed.

1151 Inlet not closed: no This message is shown in the Activity No action required. For information only.
sample aspirated Log when a measurement has been
cancelled due to inlet being closed too
late.

1152 The solution pack This message is shown in the Activity Repeat replacement operation.
chip data could not Log when a replacement of the sensor
be read or written cassette or solution pack has failed. The
during replacement reason was that it was impossible to
communicate with the chip on the
consumable.

1157 No valid FTC System error. Contact Radiometer service representa-

programs detected tive.

1160 The top termistor is The top termistor is not connected Restart the analyzer
not connected
- If still present replace top termistor

996-686C 119
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No. Message Interpretation Action

1161 The top termistor The top termistor short circuited Restart the analyzer
short circuited
- If still present replace top termistor

1163 The sensor The sensor cassette termistor is not Restart the analyzer
cassette termistor connected
is not connected - If still present replace sensor cassette

1164 The sensor Sensor cassette termistor is short Restart the analyzer
cassette termistor circuited
is short circuited - If still present replace sensor cassette

1165 Solution pack not Shown in the Activity Log when "Oper- The analyzer will automatically enter
properly installed ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1166 Solution pack Shown in the Activity Log when "Oper- The analyzer will automatically enter
expired ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1167 Sensor cassette not Shown in the Activity Log when "Oper- The analyzer will automatically enter
properly installed ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1168 Sensor cassette Shown in the Activity Log when "Oper- The analyzer will automatically enter
expired ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1169 Unable to pump Shown in the Activity Log when "Oper- The analyzer will automatically enter
solutions ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1170 Inlet has been Shown in the Activity Log when "Oper- The analyzer will automatically enter
open for too long ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1171 Inlet is missing or Shown in the Activity Log when "Oper- The analyzer will automatically enter
in unknown state ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1172 Sensor cassette Shown in the Activity Log when "Oper- The analyzer will automatically enter
damaged ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1173 Solution pack Shown in the Activity Log when "Oper- The analyzer will automatically enter
damaged ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1174 Inlet opened while Shown in the Activity Log when "Oper- The analyzer will automatically enter
the analyzer was ator-intervention required" has been "Operator-intervention required". Follow
busy entered due to this reason. the instructions shown on the screen.

1175 Sensor tempera- Hardware temperature error (Termistor). - Ensure that the ambient temperature is
ture error between 15 and 32 °C.

- If the system has just performed a cold

start, wait for the error to disappear.

- Shield the analyzer from direct sunlight

and other heat sources.

- Contact Radiometer service represen-

tative.

1176 A liquid sensor Shown in the Activity Log when "Oper- The analyzer will automatically enter
error was detected ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

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No. Message Interpretation Action

1177 A flow selector Shown in the Activity Log when "Oper- The analyzer will automatically enter
error was detected ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1178 A pump calibration Shown on screen when "Operator-inter- The analyzer will automatically enter
error was detected vention required" has been entered due "Operator-intervention required". Follow
to this reason. the instructions shown on the screen.

1180 An error occurred Shown in the Activity Log when "Oper- The analyzer will automatically enter
when trying to ator-intervention required" has been "Operator-intervention required". Follow
communicate with entered due to this reason. the instructions shown on the screen.
wet section

1181 A software or hard- Shown in the Activity Log when "Oper- The analyzer will automatically enter
ware error exists in ator-intervention required" has been "Operator-intervention required". Follow
wet section entered due to this reason. the instructions shown on the screen.

1183 Valve malfunc- Shown in the Activity Log when "Oper- The analyzer will automatically enter
tioning ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1184 Leak detected Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1185 Warning: Free The internal memory is low. - Restart the analyzer
memory is low

1186 Free system The internal memory is critically low. - Restart the analyzer
memory is critically
low

1187 Disk shows signs of The permanent memory is showing - Contact Radiometer service represen-
wear exhaustion signs and should probably be tative.
replaced soon.

1188 Disk shows serious The permanent memory is showing - Contact Radiometer service represen-
signs of wear exhaustion signs and should be replaced tative.
soon.

1189 FTC aborted, LS Shown in the Activity Log when "Oper- The analyzer will automatically enter
state change error ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1190 Inlet open Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1199 FTC program has This message is found in the Activity Log No action required. For information only.
been retried when a measurement or calibration
activity has been retried due to error.

1200 Solution pack Shown in the Activity Log when "Oper- The analyzer will automatically enter
empty ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1201 Solution pack life- Shown in the Activity Log when "Oper- The analyzer will automatically enter
time expired ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1202 Expiration date Shown in the Activity Log when "Oper- The analyzer will automatically enter
reached ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

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No. Message Interpretation Action

1203 Lifetime in analyzer Shown in the Activity Log when "Oper- The analyzer will automatically enter
exceeded ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1204 No more activities Shown in the Activity Log when "Oper- The analyzer will automatically enter
left ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1216 Lifetime in analyzer Shown in the Activity Log when "Oper- The analyzer will automatically enter
exceeded ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1217 No more tests left Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1218 Expiration date Shown in the Activity Log when "Oper- The analyzer will automatically enter
reached ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1219 RiLiBÄK Violation: The measured value lies above the No action required.
Value above upper upper RiliBÄK range.
limit

1220 RiLiBÄK Violation: The measured value lies below the lower No action required.
Value below lower RiliBÄK range.
limit

1221 System tempera- Hardware temperature error (all). - Ensure that the ambient temperature is
ture out of range between 15 and 32 °C.

- If the system has just performed a cold

start, wait for the error to disappear.

- Shield the analyzer from direct sunlight

and other heat sources.

- Contact Radiometer service represen-

tative.

1222 Temperature Hardware temperature error - Ensure that the ambient temperature is
system error (Top/bottom termistor). between 15 and 32 °C.

- If the system has just performed a cold

start, wait for the error to disappear.

- Shield the analyzer from direct sunlight

and other heat sources.

- Contact Radiometer service represen-

tative.

1223 Analyzer did not The analyzer DMS has not been able to - Restart the analyzer.
connect at start-up establish contact to the WS(M) at
start-up. - Contact Radiometer service represen-
tative.

1224 Analyzer is tempo- Shown in the Activity Log after tempo- No action required.
rarily shut down rary shutdown of the analyzer.

1225 The sample is older The time between sampler draw time Either sampler draw time has been
than a day and aspiration is larger than 1 day. entered incorrectly or time of the
analyzer is incorrect. Change either to
correct the error.

122 996-686C
ABL90 FLEX PLUS: Instructions for use Chapter 7: Troubleshooting

No. Message Interpretation Action

1226 The sample age is The time between sampler draw time Either sampler draw time has been
negative and aspiration is less than zero. entered incorrectly or time of the
analyzer is incorrect. Change either to
correct the error.

1227 Correction for Chloride is corrected for bicarbonate, No action required.

bicarbonate calculated from pH and pCO2. Errors
contains errors from pH, pCO2 results in this error on
from pH, pCO2 chloride.

1228 Correction for Lactate is corrected for ion strength, No action required.
lactate contains calculated from K+, Na+, Ca2+. Errors
errors from K+, from K+, Na+, Ca2+ results in this error
Na+, Ca2+ on lactate.

1230 Inlet Gasket Holder Shown in the activity log at the time of a No action required.
replaced replacement.

1231 Inlet probe Shown in the activity log at the time of a No action required.
replaced replacement.

1232 Inlet Connector Shown in the activity log at the time of a No action required.
Gasket replaced replacement.

1233 Inlet cleaned Shown in the activity log at the time No action required.
when an inlet cleaning was performed.

1234 Demonstration Demonstration software - not for clinical No action required.

software - not for purposes
clinical purposes

1235 Failed to aspirate Aspiration failed Remove sampler. Retry aspiration

sample

1236 Failed to aspirate Aspiration failed, due to blocked inlet Remove sampler. Retry aspiration
sample

1240 Liquid transport Unstable aspiration from solution pack No action required
failed

1242 Liquid transport Unstable aspiration from solution pack No action required
failed

1243 Liquid transport Unstable aspiration from solution pack No action required
failed

1244 Liquid transport Unstable aspiration from solution pack No action required
failed

1245 Liquid transport Unstable aspiration from solution pack No action required
failed

1246 Liquid transport Unstable aspiration from solution pack No action required
failed

1247 Liquid transport Unstable aspiration from solution pack No action required
failed

1248 Liquid transport Unstable aspiration from solution pack No action required
failed

1249 Liquid transport Unstable aspiration from solution pack No action required
failed

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No. Message Interpretation Action

1250 Liquid transport Unstable aspiration from solution pack No action required
failed

1253 Failed to aspirate Aspiration failed sample not detected Retry aspiration
sample

1254 Failed to aspirate Aspiration failed sample not detected Retry aspiration
sample

1257 Liquid transport Unstable aspiration from solution pack No action required
failed

1258 Liquid transport Unstable aspiration from solution pack No action required
failed

1259 Liquid transport Unstable aspiration from solution pack No action required
failed

1260 Liquid transport Unstable aspiration from solution pack No action required
failed

1261 Liquid transport Unstable aspiration from solution pack No action required
failed

1262 Liquid transport Unstable aspiration from solution pack No action required
failed

1263 Liquid transport Unstable aspiration from solution pack No action required
failed

1264 Liquid transport Unstable aspiration from solution pack No action required
failed

1265 Liquid transport Unstable aspiration from solution pack No action required
failed

1266 Liquid transport Unstable aspiration from solution pack No action required
failed

1267 Liquid transport Unstable aspiration from solution pack No action required
failed

1268 Liquid transport Unstable aspiration from solution pack No action required
failed

1271 Failed to aspirate Aspiration failed sample not detected Retry aspiration
sample

1272 Failed to aspirate Aspiration failed sample not detected Retry aspiration
sample

1275 Liquid transport Unstable aspiration from solution pack No action required
failed

1276 Liquid transport Unstable aspiration from solution pack No action required
failed

1279 Liquid transport Unstable aspiration from solution pack No action required
failed

1280 Liquid transport Unstable aspiration from solution pack No action required
failed

1281 Liquid transport Unstable aspiration from solution pack No action required
failed

124 996-686C
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No. Message Interpretation Action

1282 Liquid transport Unstable aspiration from solution pack No action required
failed

1283 Liquid transport Unstable aspiration from solution pack No action required
failed

1284 Liquid transport Unstable aspiration from solution pack No action required
failed

1285 Liquid transport Unstable aspiration from solution pack No action required
failed

1286 Liquid transport Unstable aspiration from solution pack No action required
failed

1290 Liquid transport Unstable aspiration from solution pack No action required
failed

1292 Liquid transport Unstable aspiration from solution pack No action required
failed

1294 Liquid transport Unstable aspiration from solution pack No action required
failed

1295 Activity has been This message is shown in the activity log No action required.
repeated due to when an activity is repeated automati-
the following cally. It lists the error and parameter id
reason: that was the cause of the repeat.

1296 Printer out of paper The printer is out of paper. A new paper - Insert a new paper roll
roll must be inserted

1297 Printer is offline The printer is offline due to either a bad - Check the power connection
or missing power / USB connection
- Check the USB connection

- Contact Radiometer service represen-

tative.

1298 Printer lid open The printer lid is open - Close the printer lid

1299 Rinse activity A rinse activity has been repeated. The No action required.
repeated: following entries in the log explains the
reason for the repeat.

1300 Calibration activity A calibration activity has been repeated. No action required.
repeated: The following entries in the log explains
the reason for the repeat.

1301 QC activity A QC activity has been repeated. The No action required.

repeated: following entries in the log explains the
reason for the repeat.

1302 Startup actvity A startup activity has been repeated. No action required.
repeated: The following entries in the log explains
the reason for the repeat.

1303 Actvity repeated: An activity has been repeated. The No action required.
following entries in the log explains the
reason for the repeat.

1304 Calibration activity A calibration activity has been repeated. No action required.
repeated The following entries in the log explains
the reason for the repeat.

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No. Message Interpretation Action

1305 End of repeat This message indicates the end of repeat No action required.
reason list reasons. See errors 1299-1304.

1306 Solution pack Shown in the Activity Log when "Oper- The analyzer will automatically enter
manualy removed ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1307 Disk space less The disk space on the analyzer is low. Delete some archives to free up space
than fifteen percent on the drive.

1308 Disk space less The disk space on the analyzer is less Contact service technician
than one percent than 1 %

1309 Unable to start FTC Unable to start FTC activity Contact service technician
activity - FTC
activity in progress

1310 Response error Sensor (Metabolit) does not work prop- Replace sensor
erly

1311 The analyzer chip It's not possible to read or write data to Contact Radiometer service representa-
data could not be the analyzer chip tive.
read or written

1312 Export data logs The export data log operation has failed. - Make sure the selected export path
failed exists.

- Make sure enough space is available.

1313 Export data logs The export data log operation has No action required.
done completed succesfully.

1314 Sensor tempera- Sensor temperature error (substrate) - Check sensor status and replace, if
ture error during during rinse necessary.
rinse

1315 Cal backlog error Cal backlog error (pH), leaping signals Perform rinse
(pH) on rinse

1316 Cal backlog error Backlog unstable, leaping signals on Perform rinse
(pCO2) rinse

1317 Cal backlog error Backlog unstable, leaping signals on Perform rinse
(pO2) rinse

1318 Cal backlog error Backlog unstable, leaping signals on Perform rinse
(K) rinse

1319 Cal backlog error Backlog unstable, leaping signals on Perform rinse
(Na) rinse

1320 Cal backlog error Backlog unstable, leaping signals on Perform rinse
(Ca) rinse

1321 Cal backlog error Backlog unstable, leaping signals on Perform rinse
(Cl) rinse

1322 Cal backlog error Backlog unstable, leaping signals on Perform rinse
(Glu) rinse

1323 Cal backlog error Backlog unstable, leaping signals on Perform rinse
(Lac) rinse

1324 Inhomogeneous Shown in the Activity Log when "Oper- The analyzer will automatically enter
rinse solution (LS ator-intervention required" has been "Operator-intervention required". Follow
sensors) entered due to this reason. the instructions shown on the screen.

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No. Message Interpretation Action

1325 Sensor thermistor Show in activity log when a recalibration Information only
recalibrated of the sensor thermistor has been
performed

1326 Sensor thermistor Shown in the Activity Log when "Oper- The analyzer will automatically enter
recalibration ator-intervention required" has been "Operator-intervention required". Follow
failed - thermistor entered due to this reason. the instructions shown on the screen.
mal-functioning

1327 Analyzer locked by Operator has locked the analyzer No action required.
operator

1328 Analyzer locked on The analyzer was locked on request from No action required.
request from LIS LIS

1329 Analyzer locked on The analyzer was locked on request from No action required.
request from Radi- Radiance
ance

1330 pO2 substrate The tickness of the pO2 sunstrate is -Perform calibration -Replace sensor
thickness outside the ranges cassette

1331 Intervention The analyzer enters UIR No action required.

required entered

1332 Intervention The analyzer exits UIR No action required.

required exited

1335 Solution pack This message is used in the Activity log No action required
replaced to indicate replacement of solution pack

1336 Sensor cassette This message is used in the Activity log No action required
replaced to indicate replacement of sensor
cassette

1337 Printer paper This message is used in the Activity log No action required
replaced to indicate replacement of printer paper

1338 Demo mode This message is used in the Activity log No action required
enabled to indicate that ABL 90 demo mode has
been enabled

1339 Demo mode disa- This message is used in the Activity log No action required
bled to indicate that ABL 90 demo mode has
been disabled

1340 Sensor cassette This message is used in the Activity log No action required
maintenance by to indicate startup using a sensor
Analyzer has been cassette which has been left without an
interrupted FTC activity for more than 2 hour.

1341 Leak detected Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1342 Leak detected Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1343 Unable to pump Shown in the Activity Log when "Oper- The analyzer will automatically enter
solutions ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1344 Solution pack This message is used in the Activity log No action required
removed to indicate replacement of solution pack

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No. Message Interpretation Action

1345 Solution pack This message is used in the Activity log No action required
inserted to indicate replacement of solution pack

1346 Sensor cassette This message is used in the Activity log No action required
removed to indicate replacement of sensor
cassette

1347 Sensor cassette This message is used in the Activity log No action required
inserted to indicate replacement of sensor
cassette

1348 Warning - Battery This message is used in the Activity log Plug analyzer into mains
low to indicate low battery level

1349 Analyzer shutdown Analyzer shutdown due to low battery No action required
due to low battery

1350 Clot suspected in Clot suspected in Inlet No action required

Inlet

1351 Clot suspected in Clot suspected in sensor cassette No action required

sensor cassette

1352 Clot suspected in Clot suspected in OXI module No action required

OXI module

1353 Operator Action The analyzer has entered Operator Operator should perform action shown
Needed entered Action Needed on screen

1354 Operator Action The analyzer has exited Operator Action No action required
Needed exited Needed

1355 Conditioned Sensor Conditiones for performing a conditioned No action required

Startup sensor startup was fullfilled. The
analyzer does not initially perform cali-
bration with every measurement.

1356 Non-Conditioned Conditiones for performing a conditioned No action required

Sensor Startup sensor startup was fullfilled. The
analyzer does not initially perform cali-
bration with every measurement.

1357 Software upgrade This message is shown in the activity log No action required
initiated when a software upgrade has been initi-
ated

1358 Upgraded from This message is shown in the activity log No action required
when a software upgrade has been
performed

1359 Upgrade option: This message is shown in the activity log No action required
when a software upgrade has been
performed

1360 No clots detected This message is shown in the activity log No actions
in Analyzer when the clot detection program did not
detect any clots

1361 Internal reference The reference electrode is malfunc- Replace sensor cassette
electrode error in tioning.
sensor cassette

1362 Inlet gasket Guided troubleshooting step has been No action required
cleaning has been started by operator
started

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No. Message Interpretation Action

1363 Inlet gasket Guided troubleshooting step has been No action required
cleaning has been skipped by operator
skipped

1364 Inlet gasket Test after action by operator is ok No action required

cleaning test ok

1365 Inlet gasket Test after action by operator has failed No action required
cleaning test failed

1366 Inlet gasket holder Guided troubleshooting step has been No action required
replacement has started by operator
been started

1367 Inlet gasket holder Guided troubleshooting step has been No action required
replacement has skipped by operator
been skipped

1369 Inlet gasket holder Test after action by operator has failed No action required
replacement test
failed

1371 Solution pack Guided troubleshooting step has been No action required
replacement skipped by operator
skipped

1372 Solution pack Test after action by operator is ok No action required

replacement test
ok

1373 Solution pack Test after action by operator has failed No action required
replacement test
failed

1374 Inlet connector Guided troubleshooting step has been No action required
gasket replacement started by operator
started

1375 Inlet connector Guided troubleshooting step has been No action required
gasket replacement skipped by operator
skipped

1376 Inlet connector Test after action by operator is ok No action required

gasket replacement
test ok

1377 Inlet connector Test after action by operator has failed No action required
gasket replacement
test failed

1378 Inlet gasket holder Test after action by operator is ok No action required
replacement test
ok

1379 Solution pack Guided troubleshooting step has been No action required
replacement started by operator
started

1380 Manual flush Guided troubleshooting step has been No action required
started started by operator

1381 Manual flush Guided troubleshooting step has been No action required
skipped skipped by operator

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No. Message Interpretation Action

1382 Manual flush test Test after manual flush is ok No action required
ok

1383 Manual flush test Test after manual flush has failed No action required
failed

1384 Replace inlet The inlet gasket holder needs to be Replace inlet gasket holder
gasket holder replaced.

1386 System time No action No action

adjusted more than
2 hours

1387 Glu not usable pO2 too low for reliable cGlucose meas- N/A
urement

1388 Low Wi-Fi signal Low Wi-Fi signal quality detected No action required.
quality

1389 Unsupported Wi-Fi Wi-Fi USB adapter and/or configuration No action required.
configuration not supported

1390 Inlet cannot be The inlet cannot be closed - Remove any blocking items
closed
- Contact Radiometer service represen-
tative

1391 Inlet is not in the The inlet is not in the correct position - Contact Radiometer service represen-
correct position tative

1392 Remove sampling The inlet cannot be closed before the - Remove sampling device
device sampling device is removed
- Contact Radiometer service represen-
tative

1393 Inlet is not The analyzer has no inlet module - Install the inlet module
mounted installed
- Contact Radiometer service represen-
tative

1394 Calibration of the The analyzer could not calibrate the inlet - Contact Radiometer service represen-
inlet failed tative

1396 Sensor cassette Sensor cassette replacement is recom- Replace sensor cassette
replacement is mended
recommended

1397 Solution pack Solution pack replacement recom- Replace solution pack
replacement mended
recommended

1398 Recommended Recommended action removed. Just info No action needed

action removed

1399 Inlet Cover is Inlet Cover attached No action just info

attached

1400 Inlet Cover is Inlet Cover removed No action just info

removed

1401 Inlet Gasket Holder Inlet Gasket Holder did not return to Remove/replace the Inlet Gasket Holder
error expected position after aspiration

1402 pO2 too low. cGlu- At pO2 levels <25 mmHg, glucose line- When a sample has low pO2 levels and
cose Linearity out arity is out of range at high glucose cGlu is required, repeat the measure-
of range. concentrations ment with an arterial sample

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No. Message Interpretation Action

1403 Run Ampoule-based QC measurements must Do ampoule-based QC measurements

ampoule-based QC be done after Solution Pack replace-
measurements ments

1404 Run Ampoule-based QC measurements must Do ampoule-based QC measurements

ampoule-based QC be done after Sensor Cassette replace-
measurements ments

1405 Inconsistent data- QC lot numbers in the database do not Do the Solution Pack replacement proce-
base match those read from the smart chip in dure again with the same Solution Pack.
the Solution Pack Restart the analyzer.

1406 The analyzer is not The analyzer is not on a horizontal Put the analyzer on a horizontal surface
horizontal surface

1503 Liquid transport Unstable aspiration from solution pack No action required
failed

1506 Liquid transport Unstable aspiration from solution pack No action required
failed

1507 Liquid transport Unstable aspiration from solution pack No action required
failed

1510 Liquid transport Unstable aspiration from solution pack No action required
failed

1511 Liquid transport Unstable aspiration from solution pack No action required
failed

1514 Correction of Urea/BUN is corrected for pH. Errors No action required.

Urea/BUN contains from pH results in this error on
errors from pH Urea/BUN.

1515 Correction of Urea/BUN is corrected for K+. Errors No action required.

Urea/BUN contains from K+ results in this error on
errors from K+ Urea/BUN.

1516 Correction of Urea/BUN is corrected for Na+. Errors No action required.

Urea/BUN contains from Na+ results in this error on
errors from Na+ Urea/BUN.

1517 Correction of Urea/BUN is corrected for tHb. Errors No action required.

Urea/BUN contains from tHb results in this error on
errors from tHb Urea/BUN.

1518 Correction of Crea- Creatinine is corrected for pH. Errors No action required.
tinine contains from pH results in this error on Creati-
errors from pH nine.

1519 Correction of Crea- Creatinine is corrected for pCO2. Errors No action required.
tinine contains from pCO2 results in this error on Crea-
errors from pCO2 tinine.

1520 Correction of Crea- Creatinine is corrected for tHb. Errors No action required.
tinine contains from tHb results in this error on Creati-
errors from tHb nine.

1521 Correction of Crea- Creatinine is corrected for Creatine. No action required.

tinine contains Errors from Creatine results in this error
errors from Crea- on Creatinine.
tine

1522 Cal backlog error Backlog unstable, leaping signals on Perform rinse
(Urea/BUN) rinse

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No. Message Interpretation Action

1523 Cal backlog error Backlog unstable, leaping signals on Perform rinse
(Creatinine) rinse

1524 Cal backlog error Backlog unstable, leaping signals on Perform rinse
(Creatine) rinse

1525 Incompatible Solu- Shown in the Activity Log when "Oper- The analyzer will automatically enter
tion Pack Installed ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1526 Incompatible Shown in the Activity Log when "Oper- The analyzer will automatically enter
Sensor Cassette ator-intervention required" has been "Operator-intervention required". Follow
Installed entered due to this reason. the instructions shown on the screen.

1527 Solution Pack has Creatinine calibration solutions has Replace Solution Pack
exceeded its speci- changed significantly, invalidating the
fications for expo- creatinine calibration
sure to room
temperature

1528 Clot suspected in Clot suspected in sensor cassette No action required

sensor cassette

1529 Clot suspected in Clot suspected in sensor cassette No action required

sensor cassette

1530 Clot suspected in Clot suspected in sensor cassette No action required

sensor cassette

1531 Clot suspected in Clot suspected in sensor cassette No action required

sensor cassette

1532 Clot suspected in Clot suspected in sensor cassette No action required

sensor cassette

1533 Clot suspected in Clot suspected in sensor cassette No action required

sensor cassette

1534 Clot suspected in Clot suspected in sensor cassette No action required

sensor cassette

1535 Clot suspected in Clot suspected in sensor cassette No action required

sensor cassette

1536 Clot suspected in Clot suspected in sensor cassette No action required

sensor cassette

1537 Clot suspected in Clot suspected in sensor cassette No action required

sensor cassette

1538 Inhomogeneous cal Shown in the Activity Log when "Oper- The analyzer will automatically enter
2 solution ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1539 Inhomogeneous cal Shown in the Activity Log when "Oper- The analyzer will automatically enter
3 solution ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1540 Inhomogeneous Bubbles were detected in the QC1 solu- - Perform a refill from the auxiliary
QC1 solution tion. program.

- Replace the Solution Pack.

132 996-686C
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No. Message Interpretation Action

1541 Inhomogeneous Bubbles were detected in the QC2 solu- - Perform a refill from the auxiliary
QC2 solution tion. program.

- Replace the Solution Pack.

1542 Inhomogeneous Bubbles were detected in the QC3 solu- - Perform a refill from the auxiliary
QC3 solution tion. program.

- Replace the Solution Pack.

1543 Inhomogeneous Shown in the Activity Log when "Oper- The analyzer will automatically enter
gas ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1544 Inhomogeneous air Shown in the Activity Log when "Oper- The analyzer will automatically enter
ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1545 Internal cal value Internal cal value out of range (phi) - Check for and remedy any system
out of range (phi) messages.

- Repeat the calibration. - Check solution

pack status and replace, if necessary.

- Check sensor cassette status and

replace, if necessary.

1546 Internal cal value Internal cal value out of range (FCrnCr) - Check for and remedy any system
out of range messages.
(FCrnCr)
- Repeat the calibration. - Check solution
pack status and replace, if necessary.

- Check sensor cassette status and

replace, if necessary.

1547 Inhomogeneous cal Shown in the Activity Log when "Oper- The analyzer will automatically enter
4 solution ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1548 Urea/BUN not pH too high for reliable Urea/BUN meas- None
usable urement.

1549 Urea/BUN not pH too low for reliable Urea/BUN meas- None
usable urement.

1550 Urea/BUN not tHb too high for reliable Urea/BUN None
usable measurement.

1551 Inhomogeneous cal Shown in the Activity Log when "Oper- The analyzer will automatically enter
2 solution ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1552 Inhomogeneous cal Shown in the Activity Log when "Oper- The analyzer will automatically enter
2 solution ator-intervention required" has been "Operator-intervention required". Follow
entered due to this reason. the instructions shown on the screen.

1553 Cal expired Too long time passed since the last Perform a calibration.
(Urea/BUN) successful calibration of the parameter.
Parameter measurement values are
reported as ".....".

1554 Cal expired (Crea- Too long time passed since the last Perform a calibration.
tine) successful calibration of the parameter.
Parameter measurement values are
reported as ".....".

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No. Message Interpretation Action

1555 Cal expired (Creati- Too long time passed since the last Perform a calibration.
nine) successful calibration of the parameter.
Parameter measurement values are
reported as ".....".

1558 Battery error One or more failing cells in the battery Contact Radiometer service representa-
detected detected. tive

Battery has been

disabled

1559 Battery error One or more failing cells in the battery Contact Radiometer service representa-
detected detected. Analyzer will be locked if tive
battery is not removed or replaced
shortly.

1560 Battery error still One or more failing cells in the battery Contact Radiometer service representa-
detected detected. Analyzer will remain locked tive
until battery is removed or replaced.

1561 Battery was reset The battery reported an invalid status No action required
value and was reset in order to restore
correct function.

1562 Battery replaced A new battery was detected No action required

1563 Battery removed Battery was removed No action required

1564 Calibration status The status value is outside the range for - Check for and remedy any system
out of limits the given parameter. messages.

- Repeat the calibration.

- Check solution pack status and

replace, if necessary.

- Check sensor cassette status and

replace, if necessary.

1565 Calibration status The status value is outside the range for - Check for and remedy any system
out of limits the given parameter. messages.

- Repeat the calibration.

- Check solution pack status and

replace, if necessary.

- Check sensor cassette status and

replace, if necessary.

1566 Calibration status The status value is outside the range for - Check for and remedy any system
out of limits the given parameter. messages.

- Repeat the calibration.

- Check solution pack status and

replace, if necessary.

- Check sensor cassette status and

replace, if necessary.

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No. Message Interpretation Action

1567 Calibration status The status value is outside the range for - Check for and remedy any system
out of limits the given parameter. messages.

- Repeat the calibration.

- Check solution pack status and

replace, if necessary.

- Check sensor cassette status and

replace, if necessary.

1568 Windows Firewall Windows Firewall automatically reacti- No action required. For information only.
reactivated vated.

1569 Unable to reacti- Windows Firewall cannot be automati- Contact Radiometer service representa-
vate Windows Fire- cally reactivated. tive.
wall

1570 Clot suspected in Clot suspected in the sensor cassette No action required.
sensor cassette

1571 Persistent Clot Shown in the Activity Log when “Oper- Flush the analyzer.
detected ator-intervention required” has been
entered due to this reason.

1572 Sensor monitoring Sensor monitoring for clot detection is The analyzer will automatically enable
for clot detection is disabled until the parameter tab turns the Sensor monitoring for clot detection
temporary disabled green. when the parameter tab turns green.

1573 Sensor monitoring Sensor monitoring for clot detection is No action required. For information only.
for clot detection is enabled.
enabled

Activity log

About the Activity log

The Activity log is where activities done on or by the analyzer are saved.

To troubleshoot messages in the Activity log

1. Tap Menu > Data logs > Activity log.
2. Select the message.
3. Tap the Troubleshoot button.
4. Follow the instructions on the screen.

To see activities in the Activity log

1. Tap Menu > Data logs > Activity log.

To add a message to the Activity log

1. Tap Menu > Data logs > Activity log.
2. Tap the Add message button.
3. Enter the message.
4. Tap the Close button.

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To filter activities from the Activity log

1. Tap Menu > Data logs > Activity log.
2. Tap the Filter button.
3. In the Criteria frame, choose an option and follow the steps for it.
Option Steps

To select a time period prior to Tap the number button for the number of
today's date days you want

To select a start and end date Enter data in the Start date: and End date:
fields
4. Select the next criterion. If necessary, enter or select a value for it.
5. If necessary, do step 4 again.
6. Tap the Apply button.

Analyzer service

For service

For service, contact your local Radiometer representative. You may have to supply the
installation number (serial number) of the analyzer and the version number of the
installed software.

To find the installation number (serial number) of the analyzer

1. Tap Menu > Utilities > Setup > General setup > Analyzer settings >
Analyzer ID.
2. Read the installation number (serial number) on the screen.
NOTE: The installation number can also be found on printouts of QC, Calibration
and Patient results and on printouts from data logs.

To find the version of software installed

1. Tap Menu > Analyzer status.
2. Read the software version in the lower left corner of the screen.

136 996-686C
Shutting down, moving and
restarting the analyzer 8
Shutdown

Shutdown is a safe procedure for you to close down the analyzer. There are 2 proce-
dures a Temporary shutdown and a Long term shutdown.
NOTE: Do not use the power switch to shut down the analyzer.

Temporary shutdown of the analyzer

When to do a temporary shutdown

Usually, the analyzer is kept switched on so that it is ready to use at any time.
However, in some situations, it is necessary to do a temporary shutdown:
• When an analyzer without a battery must be moved to a new location
• When an analyzer with a low-charge level battery must be moved to a new location
• When the analyzer tells you to do a shutdown (for example, during a trouble-
shooting procedure)
• After a non-USB keyboard or mouse is connected to an analyzer that is switched on.
NOTE: If the analyzer is shut down for more than 2 hours, the Sensor Cassette must
be replaced.

To do a temporary shutdown

1. Tap Menu > Utilities > Temporary shutdown.

2. Tap the Confirm shutdown button.
3. Wait until the Windows program tells you that it is shutting down.
4. When Windows program has shut down, push the analyzer power switch to the Off
position (O).

Long-term shutdown of the analyzer

When to do a long-term shutdown

It is usually only necessary to do a long-term shutdown when the analyzer is stored.

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restarting the analyzer

To do a long-term shutdown

Required item(s)

A syringe with S5362 A syringe with

Hypochlorite Solution distilled water

Prerequisite(s)
• The Inlet Module has been cleaned

NOTE: Approximately 15 minutes are necessary for this procedure.

NOTE: The Sensor Cassette used during this procedure must not be used again.

1. Tap Menu > Utilities > Long term shutdown.

2. Tap the OK button.
The analyzer opens the inlet.
3. Hold the syringe with the S5362 Hypochlorite Solution by its barrel.
4. Follow the instructions on the screen.
5. Place and hold the tip of the syringe in the center of the inlet gasket.
6. Push the syringe into the analyzer as far as it will go and hold it there.
NOTE: Be careful not to bend the Inlet Probe.

7. Hold the syringe in the pushed-in position until the analyzer tells you that the aspi-
ration is completed.

8. When the analyzer tells you that the aspiration is completed, remove the syringe.
The analyzer closes the inlet.
9. Hold the syringe with distilled water by its barrel.

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and restarting the analyzer

10. When the analyzer tells you to, do steps 5 to 8 again.

11. Wait until the Sensor Cassette compartment opens.
12. Remove the Sensor Cassette and dispose of it as biohazardous waste.

13. Tap the Confirm removal button.

The inlet opens.
14. Wait until the Solution Pack is ejected.
15. Remove the Solution Pack and dispose of it as biohazardous waste.

The analyzer closes the inlet.

16. Wait until the Windows program tells you that it is shutting down.
17. When the Windows program has shut down, push the analyzer power switch to the
Off position (O).

Related information
Can a Solution Pack be used again?, page 40

Storing the analyzer

To store the analyzer

1. Do a long-term shutdown.
2. Put a dustcover on the analyzer.
3. Store the analyzer between -20 °C and 60 °C.

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restarting the analyzer

Moving the analyzer

To move an analyzer that has a charged battery

NOTE: The charge level of the battery must be high enough to be able to move the
analyzer and connect it to the mains power supply before the charge level drops below
11 %.

1. Disconnect the power cable and peripheral devices.

2. Lift the analyzer by its handle, keep it vertical and move it to its new location.
3. Connect the power cable and peripheral devices to the analyzer.
4. Connect the analyzer to the mains power supply before the analyzer battery
charge-level falls below 10 %.

To move an analyzer that does not have a battery

1. Do a temporary shutdown.
2. Disconnect the power cable and peripheral devices.
3. Lift the analyzer by its handle, keep it vertical and move it to its new location.
4. Connect the power cable and peripheral devices.
5. Switch on the mains power supply.
6. Push the power switch to the On position (I).
7. If the analyzer does not restart, press the standby button on the back of the
analyzer.

Restarting the analyzer

To restart the analyzer after a temporary shutdown

1. Push the power switch to the On position (I).
2. If the analyzer does not restart, press the standby button on the back of the
analyzer
NOTE: The analyzer is ready for use when it is Ready.

To restart the analyzer after a long-term shutdown

Required item(s)

A Solution Pack A Sensor Cassette

1. Use the power cable to connect the analyzer to the mains power supply.
2. Push the power switch to the On position (I) and wait until the Operator-inter-
vention required screen is shown.
3. If the analyzer does not restart, press the standby button on the back of the
analyzer.
4. Install a compatible Solution Pack.

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and restarting the analyzer

5. Install a compatible Sensor Cassette.

6. Tap the Test again button.
The analyzer is ready for use when it is Ready.

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Setup menu structure

Menu

Utilities

Setup Syringe modes

Capillary modes
Patient reports
Analysis setup Reference ranges
Sample age evaluation setup
Reportable ranges
Sample pre-registration
QC solutions
QC schedule
QC ranges
QC setup QC input setup
QC statistics
Westgard Rules
RiLiBÄK ranges
Calibration schedule

Replacement schedule
Operator activities
Replacement setup
Maintenance planning
Replacement warnings
Analyzer ID
Time / Date
Analyzer settings Acoustic signal
Barometer
Language
Parameters
Units
Parameters and input
User-defined data items
User-defined notes

RADIANCE / AQURE connection

LIS/HIS connection
Automatic data transmission
General setup Communications
Automatic data request
Patient lookup setup
Remote support

Automatic archiving
Disk functions setup
Automatic backup
Printer setup
Printers
Automatic printing

Corrective actions

Miscellaneous setup

General security
Analyzer security Operators and passwords
Access profiles

Print analyzer setup

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To print setups
1. Tap Menu > Utilities > Setup > Print analyzer setup.
2. Deselect the check buttons for the setups you do not want to print.
3. Tap the Print button.
4. If necessary, select the printer and tap the Select printer button.
5. Tap the Close button.

Analyzer configuration

Analyzer configuration

The ABL90 FLEX PLUS analyzer has 2 configurations:

Configuration for standard consumables

Supported parameters:

pH, pCO2, pO2, sO2, ctHb, FO2Hb, FCOHb, FMetHb, FHHb, FHbF, cK+, cNa+, cCa2+, cCl-,
cGlu, cLac, ctBil

Consumables:
• Sensor Cassette SC90
• Solution Pack SP90

QC systems:
• QUALICHECK5+ Solutions
• QUALICHECK7+ Solutions
• Range+ QUALICHECK Solutions

Configuration for Ki consumables

Supported parameters:

pH, pCO2, pO2, sO2, ctHb, FO2Hb, FCOHb, FMetHb, FHHb, FHbF, cK+, cNa+, cCa2+, cCl-,
cGlu, cLac, cCrea, cUrea/BUN, ctBil

Consumables:
• Sensor Cassette SC90 Ki
• Solution Pack SP90 Ki

QC systems:
• QUALICHECK7+ Solutions

To change the analyzer configuration

1. Contact your local Radiometer representative.

Managing operators

To select the logon procedure

1. Tap Menu > Utilities > Setup > Analyzer security > General security.

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2. In the Authenticate operator by field, select the option you want.

Option Action

To let most operators log on with an Operator Select “Operator ID / pass-

name: and Password:, but let some operators word as primary”
log on with a logon barcode

To let most operators log on with a logon barcode, Select “Logon-barcode as

but let some operators log on with an Operator primary”
name: and Password:

To only let operators log on with an Operator Select “Operator ID / pass-

name: and Password: word only”

To only let operators log on with a logon barcode Select “Logon-barcode only”
3. Tap the Close button.

Access profiles

An access profile specifies what an operator with the given profile can do on the
analyzer.
• The operations that can be done
• The menus and screens that can be opened
• The shortcut buttons that are available to operators

Eight access profiles are available. Access profiles may be edited, but their names
cannot be changed. No new access profiles can be created. An access profile must be
selected for each operator.

To edit an access profile

NOTE: All access profiles may be edited, but some only in part.

1. Tap Menu > Utilities > Setup > Analyzer security > Access profiles.
2. Select the access profile.
3. Select the check buttons in the Permitted actions for selected profile field.
4. Tap the Menu and buttons for selected profile button.
5. To create a shortcut button.
NOTE: You can create a shortcut button to six menus.
a) In the Available menu items: field, select the menu you want a shortcut
button for.
b) In the Button shortcuts field, select a button position for the shortcut.
c) Do these steps again for each shortcut button you want to create.
6. To create access to menus.
a) In the Available menu items: field, select the menu that you want to
create access to.
b) Tap the Select / Deselect button.
NOTE: Make sure a checkmark is shown in the selected check box.
c) Do these steps again for each menu you want to create access to.
7. Tap the Back > Close buttons.

Anonymous use

Operators do not have to log on to an analyzer that is set up for anonymous use. The
access profile selected for anonymous use specifies the shortcut buttons and menus
that anonymous operators can use.

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To set up anonymous use

1. Tap Menu > Utilities > Setup > Analyzer security > General security.
2. Select the Allow anonymous use check button.
3. Select an access profile for anonymous operators.
4. Tap the Close button.

Default operators

Some operators are set up by default.

Operator Default access to menus Can the oper-

ator be
deleted?

Manager See the default “Manager” access profile. Yes

NOTE: The password 123456 lets you log on to the
analyzer the first time the analyzer is used.

Radiometer All operator and service menus. No

Internal remote All operator and service menus. No

operator
NOTE: An Internal remote operator cannot by default
view patient data.

External remote All operator and service menus. No

operator
NOTE: An External remote operator cannot view patient
data.

To add an operator
1. Tap Menu > Utilities > Setup > Analyzer security > Operators and pass-
words.
2. Tap the Add operator button.

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3. Choose an option and follow the steps for it.

Option Steps

To let the oper- a) Enter a unique ID for the operator.

ator log on with
an Operator NOTE: Only enter 35 characters, so that the complete ID
name: and a is seen in the Logon screen.
Password:
NOTE: Do not include characters such as apostrophes (')
and slashes (/).
b) Enter the password for the operator.
NOTE: The password must contain a minimum of 4 charac-
ters.
c) Enter the password again in the Confirm: field below the
Password: field.

To let the oper- a) Enter or scan in the logon barcode for the operator.
ator log on with
a logon barcode NOTE: The logon barcode must be unique and contain a
minimum of 4 characters.
b) Enter or scan in the logon barcode again in the Confirm
field below the Logon - barcode: field.

To let the oper- a) Enter a unique ID for the operator.

ator log on with
an Operator NOTE: Do not include characters such as apostrophes (')
name: and a and slashes (/).
Password: or
with a logon NOTE: Only enter 35 characters, so that the complete ID
barcode is seen in the Logon screen.
b) Enter the password for the operator.
NOTE: The password must contain a minimum of 4 charac-
ters.
c) Enter or scan in the password again in the Confirm: field
below the Password: field.
d) Enter or scan in the logon barcode for the operator.
NOTE: The logon barcode must be unique and contain a
minimum of 4 characters.
e) Enter or scan in the logon barcode again in the Confirm
field below the Logon - barcode field.
4. Tap the Back button.
NOTE: If data is not valid, a pop-up message is shown and an acoustic signal is
sent.
5. Make sure that the operator is selected.
6. Select an access profile for the selected operator.
7. Tap the Close button.

To remove an operator
1. Tap Menu > Setup > Analyzer security > Operators and passwords.
2. Select the operator.
3. Tap the Remove operator button.
4. Tap the Close button.

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To set a logoff time for all operators

NOTE: If no time is set, operators will be automatically logged off after 3 minutes. The
maximum logoff time that can be set is 60 minutes and 50 seconds.

1. Tap Menu > Utilities > Setup > Analyzer security > General Security.
2. Tap the Log off time button.
3. Set a logoff time in minutes and seconds.
4. Tap the Back > Close buttons.

Centralized user management

Centralized user management lets a connected AQURE/RADIANCE system do some of

the management procedures usually done on the analyzer. The table shows which
procedures will have to be done on the connected AQURE/RADIANCE system if central-
ized user management is set up.

Procedures Done on the AQURE/RADI- Done on the analyzer*

ANCE system

Add new operator X

Select an access profile for a X

new operator

Remove operators X

Select the logon procedure X

Set up anonymous use of the X

analyzer

Edit an access profile X

Set the logoff time for all oper- X

ators

* These procedures can also be done remotely from a connected AQURE/RADIANCE

system.

To set up centralized user management

Prerequisite(s)
NOTE: We recommend that you use the same set of rules to add analyzer operators to
the AQURE/RADIANCE system as you use to add operators to the analyzer. If central-
ized user management is then disabled, operators can continue to log on.

1. In the connected AQURE/RADIANCE system, add present operators of the analyzer

as present operators in the AQURE/RADIANCE system.
NOTE: This is important because when centralized user management is set up, all
operator data in the analyzer is overwritten by data received from the
AQURE/RADIANCE system. Only present operators in the AQURE/RADIANCE
system can log on to the analyzer.
2. Tap Menu > Utilities > Setup > Analyzer security > General security.
3. Select the Enable centralized user management check button.
4. Select the Close button.
NOTE: This will have no effect on the activities in progress.

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Managing patient profiles

Patient profiles log

A patient profile contains data that helps to identify a patient. This data is automati-
cally saved in the Patient profiles log during sample analysis.

If a Patient ID is included in a profile, the analyzer will download all the other patient
profile data to the Patient identification screen, when the Patient ID field is filled
in. If the analyzer is set up to automatically request patient data from a LIS/HIS
system, data received from the LIS/HIS system updates data in the screen and in the
log.

To see the data saved in a patient profile

1. Tap Menu > Data logs > Patient profiles log
2. Select the patient.
3. Tap the Edit button.

To find a patient profile

1. Tap Menu > Data logs > Patient profiles log.
2. Tap the Find button.
3. Select the field of the criterion you want to use to find the patient profile. For
example Patient ID.
4. Enter data in the field.
5. Tap the Find button.

To edit a patient profile

1. Tap Menu > Data logs > Patient profiles log.
2. Select the patient profile.
3. Tap the Edit button.
4. Edit the values you want to edit.
5. Tap the Back > Close buttons.

To add a new patient profile

1. Tap Menu > Data logs > Patient profiles log.
2. Tap the Add button.
3. Enter data in the Patient ID field.
4. Enter data in other fields that help to identify the patient.
5. Tap the Back > Close buttons.

To delete a patient profile

1. Tap Menu > Data logs > Patient profiles log.
2. Select the patient profile.
3. Tap the Delete button.
4. Tap the Close button.

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Analyzer operations
To lock the analyzer

No samples can be analyzed when the analyzer is locked. However, the analyzer will
continue to do automatic calibrations.

1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. Select the Analyzer locked check button.
3. Tap the Close button.

To unlock the analyzer

This procedure lets you unlock the analyzer when an operator has locked it.

NOTE: To unlock an analyzer that is set up to lock automatically after a Solution Pack
and/or Sensor Cassette replacement: Operators must do the requested ampoule-based
QC measurements.

1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. Deselect the Analyzer locked check button.
3. Tap the Close button.

To lock/unlock parameters for measurement

A locked parameter cannot be measured. When a parameter is locked, the parameter

tab changes to red and no values are given for the parameter in result screens or in
printouts. However, locked parameters continue to be calibrated.

1. Tap Menu > Utilities > Setup > General setup > Parameters and input >
Parameters.
2. Select the parameter.
3. Tap the Lock/ Unlock button.
NOTE: The last value in the Enabled/locked column must be “Yes” to lock the
parameter, and “No” to unlock it.
4. Tap the Close button.

To show a message on the analyzer screen

The message is shown in the start screen.

1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. Enter a message in the Analyzer message frame.
3. Tap the Close button.

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Sample counter

To see an overview of measurements and tests done on the analyzer

1. Menu > Utilities > Sample counter.

Sample counter

The Sample counter screen gives an overview of the measurements and tests done
on the analyzer.

Data Description

Parameter, Count Shows the number of tests done for each parameter on patient samples
and QC solutions

Total column Shows the number of completed patient sample analyses, calibrations and
QC measurements.
NOTE: Because a parameter can be removed from a measurement, the
total number of completed measurements may not be equal to the total
number of tests.

Aborted column Shows the number of measurements stopped by the analyzer because it
found an error

User column The number of measurements done since the user counters were last set
to zero

User counters last Shows the date when the counters in the User column were last reset to
reset zero

To reset the counters in the User column

NOTE: The counter in the User column is the only counter that can be reset (set to
zero).

1. Tap the Menu > Utilities > Sample counter.

2. Tap the Reset counters button.

Analyzer settings

To set up corrective actions on system messages

Two corrective actions are available for system messages.

• Select the color of traffic light shown on the left side of the System messages
button in the Analyzer status screen
• Attach a message about the system message to the next patient result

1. Tap Menu > Utilities > Setup > General setup > Corrective actions.
2. Select the condition “System message(s) present”.

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3. Choose an option and follow the steps for it.

Option Steps

To change the traffic light color a) Tap the traffic light until it shows the color
you want.

To attach a message to the a) Select the Message on next patient result

next patient result check button.

To enable data to be scanned from barcodes

This procedure lets operators scan barcodes to enter data into more text fields than
the Patient ID, Accession no. and Sampler ID text fields.

NOTE: Radiometer recommends using barcodes with a check digit to avoid the risk of
misreading.

1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. Select the Enable general barcode support check button.
3. Tap the Close button.

To create a heading for printed data

NOTE: The text you enter in this procedure will be part of the heading that will be
shown on all printed data and data sent to LIS/HIS and AQURE/RADIANCE systems.
The Analyzer type: will also be included.

1. Tap Menu > Utilities > Setup > General setup > Analyzer settings >
Analyzer ID.
2. Enter the text for the heading (up to 25 characters). For example, a hospital or
department name.
3. Tap the Close button.

To enable the screen saver

1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. Select the Enable screen saver check button.
3. In the Screen saver frame, select the number of minutes the analyzer must not
be in use before the screen saver is shown.
4. Tap the Close button.

To set the time and date

This procedure sets the time and date on the analyzer clock. The time at which meas-
urements and activities are done are read from this clock. If there is more than 2 hours
difference between the time you set and the system time, the activity is recorded in
the Activity log.

1. Tap Menu > Utilities > Setup > General setup > Analyzer settings > Time /
Date.
2. Enter the time.
NOTE: The Current button cancels entered values.
3. Enter the date.
NOTE: The Current button cancels entered values.

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4. Tap the Close button.

To set the acoustic signals

1. Tap Menu > Utilities > Setup > General setup > Analyzer settings >
Acoustic signal.
2. Select when you want an acoustic signal to be given.
3. Use the scroll buttons to select the volume level.
4. Tap the Close button.

To mute all acoustic signals

1. Tap Menu > Utilities > Setup > General setup > Analyzer settings >
Acoustic signal.
2. Select the Mute all acoustic signals check button.
3. Tap the Close button.

To change the screen language

1. Tap Menu > Utilities > Setup > General setup > Analyzer settings >
Language.
2. In the Select a language from the list frame, select a language.
3. Tap the Set language button.
4. Tap the Continue button.
5. Choose an option and follow the steps for it:
Option Steps

To change the language immediately Tap the Continue button.

NOTE: This will restart the analyzer.

To change the language later. For a) Tap the Cancel button.

example, if you also want to change b) Restart the analyzer later.
regional settings.

To select a regional setting

A regional setting includes default values for time and date formats, the separator used
for thousands and decimals in numerical values and the layout of the keyboard shown
on the analyzer screen.

1. Tap Menu > Utilities > Setup > General setup > Analyzer settings >
Language.
2. In the Regional settings frame, select a regional setting.
3. Tap the Set regional settings button.
4. Tap the Continue button.
NOTE: This will restart the analyzer.

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To set the barometric pressure

Prerequisite(s)
• The value of the barometric pressure in your laboratory is available

This procedure makes sure that the analyzer barometer values are adjusted to the
room in which the analyzer is used.

1. Tap Menu > Utilities > Setup > General setup > Analyzer settings >
Barometer.
2. In the Adjust to: field, enter the value of the barometric pressure in your labora-
tory.
NOTE: The maximum difference between the Measured unadjusted: and Adjust
to: values that the analyzer will accept is ±19 mmHg.
3. Tap the Close button.

Related information
Environmental specifications, page 366

To log all measurement activities

By default not all measurement activities are recorded in the Activity log. This proce-
dure sets up the analyzer to record all measurement activities.

1. Tap Menu > Utilities > Setup > General setup > Miscelleneous setup.
2. Select the Log all measurement activities check button.
3. Tap the Close button.

Analysis setup

Analysis modes

Syringe modes

Syringe modes refer to the types of analysis that can be done when the inlet is in the
syringe position. The syringe mode, Syringe - S 65µL is setup by default for the anal-
ysis of patient samples in syringes. This mode can be edited and new syringe modes
created.

A Syringe - S 65µL short probe mode is also available. If a non-Radiometer syringe

is used, it may be necessary to select the Syringe - S 65µL short probe mode.
Contact your local Radiometer representative for more information.

To edit a syringe mode

1. Tap Menu > Utilities > Setup > Analysis setup > Syringe modes.
2. Tap the button for the mode you want to edit in the Primary modes or Secon-
dary modes field.
NOTE: The set of modes that holds the default mode is the one first shown during
a measurement.
3. Tap the Edit name button.

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4. If necessary, edit the name.

NOTE: The - S 65μL and/or - S 65μL short probe texts cannot be changed.
5. Tap the Parameters button.
6. If necessary, choose another option and follow the steps for it.
Option Steps

To set up a default parameter profile for Select the parameters to measure in

the mode the mode.

To let operators select the parameters Select the Select parameter profile
they want to show in patient results during measurement check button.

To set up a default parameter profile for • Select the parameters to measure in

the mode, but also let operators select the mode.
the parameters they want to show in
• Select the Select parameter
patient results
profile during measurement
check button.
7. Make sure the check buttons for parameters you want to measure in this mode are
selected.
8. Tap the Back button.
9. Tap the Layout button.
10. If necessary, select another patient report layout to be shown when you measure
in this mode.
11. Tap the Back button.
12. Tap the button for the mode you want to be the default mode.
NOTE: The default mode is the mode the analyzer will use if no other measure-
ment mode is selected.
13. Tap the Close button.

To create a new syringe mode

1. Tap Menu > Utilities > Setup > Analysis setup > Syringe modes.
2. Tap a button with no text in the Primary modes or Secondary modes field.
NOTE: The set of modes that holds the default mode is the one first shown during
a measurement.
3. Select the Button is enabled: check button.
4. Tap the button until the Measuring program: field shows the mode you want.
5. Tap the Edit name button.
6. Enter a name for the mode.
NOTE: The - S 65μL and/or - S 65μL short probe texts cannot be changed.
7. Tap the Parameters button.
8. Choose an option and follow the steps for it.
Option Steps

To set up a default parameter profile for Select the parameters to measure in

the mode the mode.

To let operators select the parameters Select the Select parameter profile
they want to show in patient results during measurement check button.

To set up a default parameter profile for • Select the parameters to measure in

the mode, but also let operators select the mode.
the parameters they want to show in
• Select the Select parameter
patient results
profile during measurement
check button.

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9. Make sure the check buttons for parameters you want to measure in this mode are
selected.
10. Tap the Back button.
11. Tap the Layout button.
12. If necessary, select another patient report layout to be shown when you measure
in this mode.
13. Tap the Back button.
14. Tap the button for the mode you want to be the default mode.
A small black mark in the top right-hand corner of the button shows that the mode
has been selected as the default.
NOTE: The default mode is the mode the analyzer will use if no other measure-
ment mode is selected.
15. Tap the Close button.

To remove a measurement mode

1. Tap Menu > Utilities > Setup > Analysis setup > Syringe modes.
2. Tap the button for the mode you want to remove.
3. Deselect the Button is enabled: check button.
4. Tap the Close button.

To select a default measurement mode

The default measurement mode is the mode the analyzer will use if no other measure-
ment mode is selected.

1. Tap Menu > Utilities > Setup > Analysis setup > Syringe modes.
2. Tap the button for the mode you want to be the default mode.
A small black mark in the top right-hand corner of the button shows that the mode
has been selected as the default.
3. Tap the Back > Close buttons.

To select a specific patient report layout for an analysis mode

Prerequisite(s)
• There is more than one patient report layout

This procedure lets you select the patient report layout that the analyzer shows during
an analysis.

1. Choose an option and follow the steps for it.

Option Steps

For analyses done with the inlet in the Tap Menu > Utilities > Setup > Anal-
syringe position ysis setup > Syringe modes.

For analyses done with the inlet in the Tap Menu > Utilities > Setup > Anal-
capillary position ysis setup > Capillary modes.
2. Tap the button for the mode in the Primary modes or Secondary modes field.
3. Make sure the Button is enabled: check button is selected.
4. Tap the Layout button.
5. Select the patient report layout to be automatically shown.
6. Tap the Back > Close buttons.

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To set up a calibration-verification mode

It is necessary to set up a calibration-verification mode before calibration-verification

measurements can be done.

1. Tap Menu > Utilities > Setup > Analysis setup > Syringe modes.
2. Tap a button with no text in the Primary modes or Secondary modes field.
3. Select the Button is enabled: check button.
4. Tap the button until the button you selected in step 2 is given the name Cal．
Verification.
5. Tap the button for the mode you want to be the default mode.
A small black mark in the top right-hand corner of the button shows that the mode
has been selected as the default.
NOTE: The default mode is the mode the analyzer will use if no other measure-
ment mode is selected.
6. Tap the Close button.

To set up an ampoule QC mode

This is an optional procedure. It lets you start ampoule-based QC measurements from

the same screen as you start patient sample analyses.

1. Tap Menu > Utilities > Setup > Analysis setup > Syringe modes.
2. Tap a button with no text in the Primary modes or Secondary modes field.
3. Select the Button is enabled: check button.
4. Tap the button until the button you selected in step 2 is given the name
Ampoule - QC.
5. Tap the button for the mode you want to be the default mode.
A small black mark in the top right-hand corner of the button shows that the mode
has been selected as the default.
NOTE: The default mode is the mode the analyzer will use if no other measure-
ment mode is selected.
6. Tap the Close button.

Capillary modes

Capillary modes refer to the types of analysis that can be done when the inlet is in the
capillary position.

The capillary mode Capillary - C 65µL is set up by default for the analysis of patient
samples in capillary tubes. The mode can be edited.

To edit a capillary mode

1. Tap Menu > Utilities > Setup > Analysis setup > Capillary modes.
2. Tap the button for the mode you want to edit in the Primary modes or Secon-
dary modes field.
NOTE: The set of modes that holds the default mode is the one first shown during
a measurement.
3. Tap the Edit name button.
4. If necessary, edit the name.
NOTE: The text - C 65µL or - C 45µL* cannot be changed.

* C 45µL is not available with configuration featuring creatinine and urea/BUN.

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5. Tap the Parameters button.

6. If necessary, choose another option and follow the steps for it.
Option Steps

To set up a default parameter profile for Select the parameters to measure in

the mode the mode.

To let operators select the parameters Select the Select parameter profile
they want to show in patient results during measurement check button.

To set up a default parameter profile for • Select the parameters to measure in

the mode, but also let operators select the mode.
the parameters they want to show in
• Select the Select parameter
patient results
profile during measurement
check button.
7. Make sure the check buttons for parameters you want to measure in this mode are
selected.
8. Tap the Back button.
9. Tap the Layout button.
10. If necessary, select another patient report layout to be shown when you measure
in this mode.
11. Tap the Back button.
12. Tap the button for the mode you want to be the default mode.
A small black mark in the top right-hand corner of the button shows that the mode
has been selected as the default.
NOTE: The default mode is the mode the analyzer will use if no other measure-
ment mode is selected.
13. Tap the Close button.

Ranges and critical limits

About ranges and critical limits

Measurement results are marked by symbols to show where they fall in relation to
reference ranges, critical limits and reportable ranges. The diagram illustrates these
relationships.

1 Reference range 4 Reportable range

2 Lower critical limit 5 Range of indication

3 Upper critical limit

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About reference ranges

A reference range is the range of test values expected for a healthy population of indi-
viduals or some other defined group. Patient results that lie outside the limits will be
marked with the symbols:

Reference ranges are valuable guidelines for the clinician, but they should not be
regarded as absolute indicators of health and disease. Reference ranges should be
used with caution since values for 'healthy individuals often overlap significantly with
values for persons afflicted with disease. In addition, laboratory values may vary
significantly due to methodological differences and mode of standardization [1].

Reference ranges are not set up by default. Laboratories must establish their own
ranges. If reference ranges are set up, patient results that lie outside the limits will be
marked with symbols.
Related information
Symbols on patient results, page 28

Reference range of measured parameters

The Radiometer publication Bulletin No: 44, Compendium of reference intervals

(product code 918-714) is available on request. Contact your local Radiometer repre-
sentative. Other documents about reference ranges/intervals can be accessed on the
www.acutecaretesting.org website.

About critical limits

Critical limits are not set up by default. Laboratories must establish their own critical
limits. If critical limits are set up, patient results that lie outside the limits will be
marked with the symbols: .

The symbols may be used to indicate when a value is dangerously high or low.

Related information
Symbols on patient results, page 28

To set the limits for patient age groups

This procedure is necessary if the reference ranges are not the same for all age
groups.
NOTE: The age groups you set are for all parameters, they are not parameter-specific.

1. Tap Menu > Utilities > Setup > Analysis setup > Reference ranges.
2. Tap the Age groups button.
3. Use the left or right arrow buttons to select an age-limit field.
4. Select an age limit for the selected field.
5. Do steps 3 and 4 again to set the limits for each age group.
NOTE: The youngest age group always starts at zero years. The oldest age group
always starts at the highest selected age limit. For example, if the highest selected
age limit is 70 years, the oldest age group is from 70 to 70+ years.
6. Tap the Back > Close buttons.

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To set up reference ranges and critical limits

Prerequisite(s)
• Patient age groups have been set

Laboratories should establish their own reference ranges.

1. Tap Menu > Utilities > Setup > Analysis setup > Reference ranges.
2. Select a parameter in the Parameter: field.
3. If the reference ranges of the selected parameter are dependent on a specific type
of patient sample, select the Sample type check button.
4. If the reference ranges of the selected parameter are dependent on the age of
patients, select the Age group check button.
5. If the reference ranges of the selected parameter are dependent on the sex of
patients, select the Sex check button.
6. Select a setting for each of the buttons selected in steps 3, 4 and 5.
7. Tap the Edit button.
8. Enter values for the reference range and the critical limits.
If an entered value is not accepted, it will be removed and a message will be
shown for a short period of time in a window on top of the screen.
9. Tap the Back button.
10. Do steps 6 to 9 again for each of the combinations of sample type, age and/or sex.
11. Do steps 2 to 10 again for each parameter.
12. Tap the Close button.

About reportable ranges

Reportable range is the range of results from a testing system or method over which
analytical performance is claimed.

Patient results that lie outside the limits will be marked with the symbols:

Related information
Ranges of indication and reportable ranges, page 357
Symbols on patient results, page 28
About range of indication, page 161

To set up reportable ranges

NOTE: Symbols are shown on test results that fall outside the reportable range of the
measured parameter.

1. Tap Menu > Utilities > Setup > Analysis setup > Reportable ranges.

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2. Choose an option and follow the steps for it.

Option Steps

To set the reportable range of a) Tap the Set all default button.
all parameters to the default b) Tap the Continue button.
values

To set the reportable range for a) Select a parameter in the Parameters field.
a parameter to the default b) Tap the Set default button.
value

To set the reportable range for a) Select the parameter in the Parameters
a parameter field.
b) Enter new values for the upper and lower
limits of the reportable range.

3. Tap the Close button.

About range of indication

The range of indication is the range within which that the analyzer can physically
measure.

Sample pre-registration

About sample pre-registration

Sample pre-registration lets operators make sure that the patient data shown on the
screen belongs to the patient whose sample is to be analyzed. This reduces the risk of
patient/sample mix-up.

NOTE: The analyzer must be set up for sample pre-registration.

Related information
To set up sample pre-registration, page 161

To set up sample pre-registration

1. Tap Menu > Utilities > Setup > Analysis setup > Sample pre-registration.
2. Select a value in the Interpret barcode input as field.
3. Make sure that check buttons are selected for the data fields you want included in
the Patient identification screen shown during pre-registration.
NOTE: A data field is automatically included for the value you selected in step 2.
4. Tap the Close button.

Sample age evaluation

About sample age evaluation

Sample age evaluation lets the analyzer calculate the age of patient samples and
compare it to the value set in the Sample age rule in minutes value. Samples older
than this value will be analyzed but a message attached to the patient result will indi-
cate that the sample was old.

The calculation is based on the sample Draw time entered on the Patient identifica-
tion screen:

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[Sample age] = [Time the sample aspiration starts] - [Time the sample was collected].

Maximum sample age

Maximum sample age is the maximum period of time that should elapse between when
a sample is collected and when it is analyzed. How the sample is stored and handled
after it is collected has an effect on the maximum sample age.

NOTE: Maximum sample age is not the same as the Max sample age.

Related information
Storage recommendations, page 19

To set a maximum sample age

The Sample age rule in minutes value is set by default to the same value for all
parameters. However, a value can be set for each individual parameter.

NOTE: You must include the Sample age item in your patient report layouts to see
calculated values.

1. Tap Menu > Utilities > Setup > Analysis setup > Sample age evaluation
setup.
2. Select the Enable sample age evaluation check button.
3. Choose an option and follow the steps for it.
Option Steps

To select the same • Select a maximum sample age for the parameter
maximum sample age for in the Sample age rule in minutes field.
all parameters
• Select the Same rule for all the parameters
check button.

To select a maximum • Select a parameter.

sample age for a param- • Select a maximum sample age for the parameter
eter
in the Sample age rule in minutes field.
4. Tap the Close button.

Max sample age

Max sample age is a value that can be received from the AQURE / RADIANCE
systems as a result of a query on sampler ID. The Max sample age will overrule the
sample age setting on the analyzer for the sample in question.

Patient report layouts

About patient report layouts

A patient report layout has 2 parts:

• A patient ID part – lets you create the content and layout of the Patient identifi-
cation screen
• A patient results part – lets you create a template for the content and layout of the
Patient results screen

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You can select a default patient report layout. The default report layout is the Report
layout shown in the Patient identification screen when it opens.

To create a patient report layout

1. Tap Menu > Utilities > Setup > Analysis setup > Patient reports.
2. Tap the New button.
3. Enter a name for the report in the Name: field.
4. Tap the Edit patient ID layout button.
5. To add data items to the layout:
a) Select a data item In the Available items frame.
b) Tap the right arrow button.
NOTE: Data items are shown in the layout as you add them.
c) Do steps a) and b) again for each data item you want to add.

Option Steps

If patient data is to be automatically Add the data item that was selected in the
requested from a LIS/HIS or AQURE/RADI- Interpret barcode input as field during
ANCE system the sample pre-registration setup procedure.

If patient data is to be manually requested Add the data field selected in the Request
from a LIS/HIS or AQURE/RADIANCE system patient demographics frame during the
automatic requests for patient data proce-
dure.

It will be one of the items: Sampler ID,

Patient ID or Accession no．

NOTE: If more than one of these items are

added, it is the item closest to the top of the
Patient identification screen that must be
filled before you can manually request
patient data from the LIS/HIS or
AQURE/RADIANCE system.

If patient data is to be looked up, found and Add the “Department (Pat.)” data item.
requested manually

If the analyzer is connected to a RADIANCE Add the Max sample age item.
system.
The value shown in this field will show the
value set in the RADIANCE system.

6. To make a data item mandatory:

a) Select the data item in the Selected items frame.
b) Tap the Set as mandatory button.
NOTE: The mandatory icon is shown adjacent to the data item.
7. To set a default value for a data item, choose an option and follow the steps for it.
Option Steps

To enter a value a) Select the data item in the Selected items frame.
b) Tap the Keyboard button.
c) Enter a value.

To select a value from a a) Select the data item in the Selected items frame.
data item list b) Tap the List button.
c) Select a value in the Available values field.
d) Tap the Select button.

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8. Tap the Back button.

9. Tap the Edit patient results layout button.
10. To add a heading for a group of parameters:
a) In the Available items frame, select a heading. For example, “Blood gas
values”.
b) Tap the right arrow button.
11. To add a parameter:
a) In the Available items frame, select a parameter.
b) Tap the right arrow button.
NOTE: Parameters will be shown in the results as they are shown in the
Selected items field.
c) If necessary, do steps a) and b) again.
12. To change the position of an item in the Selected items frame:
a) Select the item.
b) Tap the left arrow button.
c) In the Selected items frame, select the item you want the selected item to
follow.
In the Available items frame, select the item you selected in step a).
d) Tap the right arrow button.
13. To show the reference range of a parameter with patient results:
a) In the Selected items frame, select a parameter.
b) Tap the Show ranges button.
c) If necessary, do steps a) and b) again for other parameters.
14. Tap the Back > Close buttons.

Related information
To select a patient report layout as default, page 165

To change a patient result layout

This procedure tells you how to change the patient result layout for a selected layout.

1. Tap Menu > Utilities > Setup > Analysis setup > Patient reports.
2. Select the layout.
3. Tap the Edit patient results layout button.
4. To add a heading for a group of parameters:
a) In the Available items frame, select a heading. For example, “Blood gas
values”.
b) Tap the right arrow button.
5. To add a parameter:
a) In the Available items frame, select a parameter.
b) Tap the right arrow button.
NOTE: Parameters will be shown in the results as they are shown in the
Selected items field.
c) If necessary, do steps a) and b) again.
6. To change the position of an item in the Selected items frame:
a) Select the item.
b) Tap the left arrow button.
c) In the Selected items frame, select the item you want the selected item to
follow.
d) Tap the right arrow button.
7. To show the reference range of a parameter with patient results:
a) In the Selected items frame, select a parameter.
b) Tap the Show ranges button.
c) If necessary, do steps a) and b) again for other parameters.
8. Tap the Back > Close buttons.

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To create extra items for use in patient report layouts

1. Tap Menu > Utilities > Setup > General setup > Parameters and input >
User-defined data items.
2. Choose an option and follow the steps for it.
Option Steps

To create a text a) Tap the Add button.

item. b) Enter the name of the item.
NOTE: Only enter 20 characters, so that the complete
name is seen in the Patient Identification screen.
c) Select “Text” in the field on the right of the screen.
d) Tap the Select button.
e) Tap the Back button.

To create a a) Tap the Add button.

numerical item. b) Enter the name of the item.
NOTE: Only enter 20 characters, so that the complete
name is seen in the Patient Identification screen.
c) Select “Numerical” in the field on the right of the screen.
d) Tap the Select button.
e) Enter the name of the unit.
f) If entered numbers must have a fixed number of decimals
to be accepted, select the number of decimals. Tap the
Select button.
g) If entered numbers must fall within a range to be
accepted, enter the maximum and minimum values of the
range.
h) Tap the Back button.

To create a selec- a) Select the item.

tion list for an b) Tap the Edit button.
existing text or
numerical item. c) Tap the Use selection list check button.
d) Tap the Add button.
NOTE: A
minimum of 2 e) Enter a value.
values must be f) Do steps d) to e) again for each item you want in the
added to create a selection list.
list. g) Tap the Use selection list check button.
h) Tap the Back button.
3. Tap the Close buttons.

To select a patient report layout as default

The patient report layout you select as default is the one shown in the Patient identi-
fication screen when it opens.

1. Tap Menu > Utilities > Setup > Analysis setup > Patient reports.
2. Select the layout.
3. Tap the Make default button.
4. Tap the Close button.

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To automatically change the temperature units

The analyzer can be set up to let temperatures (for example, patient temperatures) be
entered in Celcius (°C) or Fahrenheit (°F) degrees. However, this procedure lets the
analyzer automatically change the set up temperature unit from °F to °C if an operator
enters °C values in a °F temperature field and vice versa.

Examples: If 41 is entered as the patient temperature in a °F temperature field, the

analyzer will automatically change the unit to °C. If 105 is entered as the patient
temperature in a °C temperature field, the analyzer will automatically change the unit
to °F.

1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. Select the Auto temp unit conversion check button.
3. Tap the Close button.

To edit a patient report layout

NOTE: Tap the -R- Default button to change selected items back to items in the Radiometer
default report layout.
1. Tap Menu > Utilities > Setup > Analysis setup > Patient reports.
2. Select the layout.
3. Tap the Edit patient ID layout button.
4. To add an item to the layout:
a) Select an item In the Available items frame.
b) Tap the right arrow button.
NOTE: Items are shown in the layout as you add them.
5. To remove an item from the layout:
a) Select an item In the Selected items frame.
b) Tap the left arrow button.
6. To make an item mandatory:
a) Select the item in the Selected items frame.
b) Tap the Set as mandatory button.
7. To set a default value for an item:
a) Select the item in the Selected items frame.
b) Tap the Keyboard button and enter a value, or: (1) Tap the List button. (2)
Select a value. (3) Tap the Select button.
8. Tap the Back button.
9. Tap the Edit patient results layout button.
10. To add a heading for a group of parameters:
a) In the Available items frame, select a heading. For example, “Blood gas
values”.
b) Tap the right arrow button.
11. To add a parameter:
a) In the Available items frame, select a parameter.
b) Tap the right arrow button.
NOTE: Parameters will be shown in the results as they are shown in the
Selected items field.
c) If necessary, do steps a) and b) again.

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12. To change the position of an item in the Selected items frame:

a) Select the item.
b) Tap the left arrow button.
c) In the Selected items frame, select the item you want the selected item to
follow.
In the Available items frame, select the item you selected in step a).
d) Tap the right arrow button.
13. To show the reference range of a parameter with patient results:
a) In the Selected items frame, select a parameter.
b) Tap the Show ranges button.
c) If necessary, do steps a) and b) again for other parameters.
14. Tap the Back button.
15. If necessary, enter a new name for the report in the Name: field.
16. Tap the Close button.

̄
To create a patient report layout for FShunt and ctO2(a-v)

1. Tap Menu > Utilities > Setup > Analysis setup > Patient reports.
2. Select the -R- Default layout.
3. Tap the Copy button.
4. Enter a name for the report in the Name: field.
5. Tap the Edit patient ID layout button.
6. Select pO2(v̄) in the Available items frame.
7. Tap the right arrow button.
8. Do steps 5 and 6 again for these parameters:
• sO2(v̄)
• FO2(I)
• RQ
• T
9. If necessary, select another patient identifier in the Available items frame.
10. Tap the right arrow button.
11. Do steps 8 and 9 again for each data item you want to add.
12. Tap the Back button.
13. Tap the Edit patient results layout button.
14. Select FShunt in the Available items frame.
15. Tap the right arrow button.
16. Select ctO2(a-v)̄ in the Available items frame.
17. Tap the right arrow button.
18. Tap the Back > Close buttons.

Patient result settings

To set up automatic printing of acid-base charts

This procedure lets you set up the analyzer to automatically print acid-base charts
when a selected report layout is used during a measurement.

1. Tap Menu > Utilities > Setup > Analysis setup > Patient reports.
2. Select a report layout.
3. Select the Print Acid-Base chart check button.
NOTE: Acid-base charts are only printed when all necessary parameter values are
available.

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4. Tap the Close button.

Approval and rejection of patient results

Approval/rejection of patient results is not set up by default. If it is set up, it can be

used to filter patient results that are transmitted to a LIS/HIS system. Approved
results are transmitted, rejected results are not.

NOTE: An approved patient result does not indicate that the result can be used in a
clinical evaluation of the patient.

Approval can for example be used to make sure that necessary data was correctly
entered, for example, that the Sample type was “Venous”, not “Arterial” and the
patient temperature was 42 °C, not 38 °C.

NOTE: Approved/rejected results can only be edited by operators with approval rights.

To enable patient result approval/rejection

1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. Select the Enable patient result approval check button.
3. Tap the Close button.

Parameter settings
To show the parameter bar
1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. Select the Show parameter bar check button.
3. Tap the Close button.

To hide the parameter bar

1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. Deselect the Show parameter bar check button.
3. Tap the Close button.

To enable/disable a parameter

When you disable a parameter, it will not be shown in the parameter bar. You cannot
measure the parameter, it will not be calibrated and no built-in QC measurements will
be done for it.

NOTE: You cannot disable the pH, pO2 or pCO2 parameters .

1. Tap Menu > Utilities > Setup > General setup > Parameters and input >
Parameters.
2. Select the parameter.
3. Tap the Enable/ Disable button.
NOTE: The first value in the Enabled/locked column must be “Yes” to enable the
parameter, and “No” to disable it.

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4. Tap the Close button.

To set up measuring units for parameters

1. Tap Menu > Utilities > Setup > General setup > Parameters and input >
Units.
2. Use the scroll buttons to select the field adjacent to the parameter.
3. In the Possible units frame, select the unit.
4. Tap the Close button.

To repress a parameter

When you repress a parameter, no value will be given for the parameter in patient
results if an error occurred during the measurement.

If an QC or calibration problem exists repressing a parameter will change the param-

eter tab to red and repress that parameter in subsequent patient results.

1. Tap Menu > Utilities > Setup > General setup > Parameters and input >
Parameters.
2. Select the parameter.
3. Tap the Edit button.
4. Select the Repress parameter value in patient result in case of any prob-
lems check button.
5. Tap the Back > Close buttons.

To suppress out-of-range results

Only out-of-range oximetry and ctBil parameters can be suppressed.

• Suppression causes oximetry results (excluding ctHb) that are within the range of
indication and below zero to be shown as zero, and results that are within the range
of indication and above 100 % to be shown as 100 %.
• Suppression of ctHb and ctBil results that are within the range of indication but
below zero will be shown as zero.

1. Tap Menu > Utilities > Setup > General setup > Parameters and input >
Parameters.
2. Select the parameter.
3. Tap the Edit button.
4. Select the Out of range suppression check button.
5. Tap the Back > Close buttons.

To fix the number of decimals used in blood-gas results

The analyzer measures the blood gas parameters pO2 and pCO2 more precisely in the
lower part than in the upper part of ranges. By default, results are shown with a
different number of decimal points. For example, in the range 0-99.9 mmHg, pO2(T)
results are shown with one decimal point and in the range 100-750 mmHg, with no
decimal points (that is, in whole numbers).

This procedure can be used to make sure pO2 and pCO2 results are shown with the
same number of decimal points in the whole reportable range.

1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. Select the Fixed pO2/pCO2 decimals check button.

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3. Tap the Close button.

Related information
Measurement precision within specified ranges, page 359

To enable HbF corrections

Prerequisite(s)
• You know if the analyzer is to be used to analyze neonatal samples only, adult
samples only, neonatal samples and adult samples or samples that contain hemo-
globins that deviate from HbA hemoglobins

This procedure is necessary to make sure that ctBil, sO2, FO2Hb, FMetHb, FCOHb and
FHHb results are corrected for the presence of HbF in the sample.

1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. In the HbF correction frame, choose an option and follow the steps for it.
Option Steps

For neonatal samples Select “Enabled for all levels”

For adult samples Select “Enabled for levels > 20 %”

For neonatal and adult samples Select “Enabled for levels > 20 %”

For adult samples that contain hemo- Select “Disabled”

globins which deviate from HbA hemo-
globins

NOTE: The “Enabled for all levels” setting will correct ctBil, sO2, FO2Hb, FMetHb,
FCOHb and FHHb results and show HbF values.
3. Tap the Close button.

Related information
Restrictions, page 354

To enable the estimation of derived parameters

This procedure lets the analyzer replace missing measured values and/or keyed-in
values with default values in order to estimate values for derived parameters. Esti-
mated results are marked with the subscript e.

1. Tap Menu > Utilities > General setup > Miscellaneous setup.
2. Select the Enable estimated derived parameters check button.
3. Tap the Close button.

Related information
Derived parameters, page 292

Editing the slope and offset of a parameter

Operator-defined corrections (offset and slope)

Operator-defined corrections refer to corrections made to the offset and/or slope of

parameters.

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2 5

0.0 3

1 Offset 4 Correction line without

user-defined corrections (slope =
1, offset = 0)

2 Displayed (corrected) parameter 5 Correction line with user-defined

value (y axis) corrections

3 Measured (uncorrected) parameter

value (x axis)

The diagram shows the relation between correction lines with and without oper-
ator-defined corrections.

Operator-defined corrections are most commonly applied when the values measured
for a parameter by two or more analyzers deviate consistently from each other.

Operator-defined corrections are based on a linear correlation between the measured

values (without operator-defined corrections) and the shown values (with oper-
ator-defined corrections).

The correction factors for each measured parameter are the slope and the offset of the
correction line. With operator-defined corrections it is possible to change the values of
the slope and offset or only change the value of one of them. This depends on the
parameter.

Corrected value = Slope × Uncorrected value + Offset

Before you enter corrections for a parameter, you must have the reference value for
the parameter. Use a procedure accepted in your laboratory to get the reference value.

Here are the other prerequisites:

• Analyses must be done on the analyzer without the use of operator-defined correc-
tions and on one reference analyzer
• Analyses must be done over the full measuring range
• Analyses must be done on the analyzer and on the reference analyzer at the same
time, and the samples must be handled correctly
• The slope and the offset must be calculated. You may, for example, make a linear
correlation between the values measured on the analyzer and the reference
analyzer. The analyzer is then used as an independent variable.
• You must verify the corrections entered.

Recommendations about samples to use

Parameter Sample description

ctHb Use a SAT100 sample to approximately 15 g/dL (9.3 mmol/L) (which is the
maximum uncorrected or corrected point) and pH is approximately 7.4

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Parameter Sample description

sO2 Set ctHb of gas equilibrated SAT0 and SAT100 sample to approximately 15 g/dL
(9.3 mmol/L) and pH is approximately 7.4

FCOHb The zero point (FCOHb approximately zero) is saturated to approximately SAT100,
and ctHb is set to approximately 15 g/dL (9.3 mmol/L) and pH is approximately
7.4

FMetHb The zero point (FCOHb approximately zero) is saturated to approximately SAT100,
and ctHb is set to approximately 15 g/dL (9.3 mmol/L) and pH is approximately
7.4

FHbF Radiometer recommends that the ctHb in adult samples (with FHbF = 0) and fetal
samples (with high FHbF) is set to approximately 15 g/dL (9.3 mmol/L), sO2 is
approximately 100 % and pH is approximately 7.4

ctBil Radiometer recommends that human plasma or serum is used with pH = 7.4 (the
analyzer reading). Zero point sample could be adult sample (ctBil)

Limits for slope and offset values

The slope and offset value of some parameters can be changed to values that fall
within the limits stated in the tables.

• For arterial, venous and a-v̄ samples:

Limits for pH and blood gases

Parameter Limits for the slope Limits for the offset value
value

pH 0.95-1.05 ±0.1 (pH unit)

pCO2 0.95-1.05 ±0.5 kPa

pO2 0.95-1.05 ±0.5 kPa

Limits for electrolyte parameters

Parameter Limits for the slope value Limits for the offset value
(mmol/L)

cK+ 0.75-1.25 ±0.3

cNa+ 0.85-1.15 ±5

cCa2+ 0.8-1.2 ±0.05

cCl - 0.85-1.15 ±5

Limits for metabolite parameters

Parameter Limits for the slope value Limits for the offset value

cGlu 0.75-1.25 ±0.5 mmol/L

cLac 0.75-1.25 ±0.5 mmol/L

cUrea 0.9-1.1 ±3.0 mmol/L

cCrea 0.75-1.25 ±100 µmol/L

cBUN 0.9-1.1 ±8.4 mg/dL

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Limits for oximetry parameters

Parameter Limits for the slope Limits for the offset value
value

ctHb 0.95-1.05 ±2 mmol/L

sO2 0.9-1.1 ±0.05 (fraction)

FCOHb Cannot be changed ±0.05 (fraction)

FMetHb Cannot be changed ±0.05 (fraction)

FO2Hb Cannot be changed If measurements indicate that it is necessary

to change the offset value for sO2 and/or
FCOHb and/or FMetHb, change it. Use the
equation: sO2 × (1 – FCOHb – FMetHb) to
calculate FO2Hb concentrations.

FHHb Cannot be changed If measurements indicate that it is necessary

to change the offset value for sO2 and/or
FCOHb and/or FMetHb, change it. Use the
equation: (1 – sO2) × (1 – FCOHb – FMetHb)
to calculate FHHb concentrations.

FHbF 0.8-1.2 ±0.2 (fraction)

NOTE: Before samples

are analyzed, “Enabled
for all levels” must be
selected for HbF
correction in the
Miscellaneous setup
screen.

ctBil 0.5-1.5 ±100 (µmol/L)

Related information
To enable HbF corrections, page 170

To edit the offset and slope for a parameter

WARNING – Risk of incorrect measurement results

Changes made to the offset and/or slope of parameters will have an effect on patient
results and change some performance characteristics. If you do not want the changes
to have an effect on QC results, too, make sure the Apply parameter corrections to
QC check button is deselected in the Miscellaneous setup screen.

1. Tap Menu > Utilities > Setup > General setup > Parameters and input >
Parameters.
2. Select the parameter.
3. Tap the Edit button.
4. If necessary, enter a new value for Correction offset.
5. If necessary, enter a new value for Correction slope.
6. Tap the Back > Close buttons.

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Calibration settings

Details about calibration frequency

By default the analyzer is set up to do automatic calibrations and built-in QC measure-

ments at intervals that enable optimum use to be made of materials in the Solution
Pack. The table provides details.

NOTE: Automatic calibrations are also done when the Sensor Cassette or Solution Pack
are replaced, in connection with maintenance and troubleshooting procedures and
when the analyzer is restarted.

Calibration identifier Calibration Calibration mate- Default frequency Default

(parameters) rial start time

Elec, pH Sensitivity CAL 1 solution Once a day 08:00

hours
(cK+, cNa+, cCa2+, CAL 2 solution
cCl–, pH)
Status CAL 1 solution Every measurement N/A

BG, Met Sensitivity CAL 1 solution Every 4 hours 02:00

hours
(pCO2, cGlu, cLac, CAL 3 solution
cCrea*, cUrea/BUN*)
Status CAL 1 solution Every measurement N/A

BG Sensitivity CAL 1 solution Once a day 16:00

hours
(pO2) Ambient air

Status CAL 1 solution Every measurement N/A

Oxi Sensitivity CAL 1 solution Every 3 months N/A

(recommended)
(Oximetry parameters) ctHb calibration solu-
tion (S7770)

Status CAL 3 solution • Every 4 hours N/A

• When tempera-
ture drift in the
oximetry optical
system is outside
specified limits

Met (cCrea*, Sensitivity CAL 1 solution Once a day 05:00

cUrea/BUN*) hours
Selectivity CAL 2 solution

phi CAL 3 solution

CAL 4 solution

* Parameters only available on analyzers configured to feature creatinine and

urea/BUN.

NOTE: The calibration identifier BG, Met , Oxi and BG, Elec, Met, pH are combina-
tions of those listed in the table.

Related information
Calibration frequency after a Sensor Cassette SC90 replacement, page 42

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To edit the calibration schedule

NOTE: Changes made to the default schedule may prevent optimum use of solutions in
the Solution Pack. This is because the automatic calibrations and built-in QC measure-
ments are scheduled by default to be done at times that let the analyzer make
optimum use of the calibration and QC materials in the Solution Pack.
This procedure lets you change the default schedule for calibrations, (automatic cali-
brations) and tHb calibrations (sensitivity calibration of oximetry parameters, which is a
manual calibration).

1. Tap Menu > Utilities > Setup > Calibration schedule.

2. Choose an option and follow the steps for it.
Option Steps

To change the • Select “Calibration” as the Calibration type.

start time for • Tap the Edit button.
automatic cali-
brations • Select a new Start time.

NOTE: The schedule above shows both the default calibra-

tion schedule as well as the default start time for a number
of specific system checks that are scheduled to start at
00:00 (24:00) hours. The change you make to the start
time in this step will change the start time for both auto-
matic calibrations and other system checks. For example, if
the start time is changed from 00:00 to 02:00 hours, auto-
matic calibrations will be delayed by 2 hours.

To change the • Select “tHb Cal” as the Calibration type.

start time for • Tap the Edit button.
the next sensi-
tivity calibration • Select a Start time.
of tHb • Select an Interval setting.
NOTE: The day the next calibration is scheduled = [current
date] + [Interval setting].

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To link the built-in QC schedule to the calibration schedule

This procedure changes the current schedule for built-in QC measurements to the
default schedule. This lets the analyzer make optimum use of the solutions in the Solu-
tion Pack.

1. Tap Menu > Utilities > Setup > Calibration schedule.

2. Select “Calibration” in the Calibration type field.
3. Select the Link QC schedule with calibration schedule check button.
4. Tap the Close button.

To set up corrective actions for overdue scheduled calibrations

This procedure lets you select what the analyzer must do when scheduled calibrations
are overdue.

1. Tap Menu > Utilities > Setup > General setup > Corrective actions.
2. Select “Calibration schedule reminder(s)”.
3. Choose an option and follow the steps for it.
Option Steps

To select the color of the traffic light Tap the Traffic light signal check
signal on the Analyzer status button button until it shows the color you want

To attach a message about the overdue Make sure the check button in the
scheduled calibration to patient results Corrective action(s) frame is selected
4. Tap the Close button.

Quality control
Glossary of quality control terms

Term Explanation

Accepted result A QC result that falls within the statistical range

Assigned value The assigned value is the center value of a control range.

NOTE: For Radiometer quality control solutions used for ampoule-based QC

measurements, control ranges are given in the insert.

Control range The range within which a QC result should fall. The control range is calculated
to be the mean value ± 2 SD.

NOTE: This range can be set to the lot-to-date range (2 SD) calculated by the
analyzer.

Insert range The upper and lower limits of a control range established for a Radiometer
quality control solution.

The ranges are calculated from the results of 30-50 QC measurements done
on each of 10 analyzers. Measurements are done 2-5 times a day over a
period of 1-4 weeks.

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Term Explanation

Lot-to-date A range calculated by the analyzer based on a minimum number of measure-

range ments done with a specific lot of a quality control solution. It is the mean
value ±2 SD.

Statistical factor The factor which a control range is multiplied by to determine the statistical
range. The recommended statistical factor is 1.5.

Statistical range The range within which a QC result must fall in order to be included in the QC
statistics. It is determined by multiplying the control range limits by the stat-
istical factor. When the recommended statistical factor of 1.5 is used, the stat-
istical range will be the mean ±3 SD.

Registration of QC solutions

Why is it necessary to register QC solutions?

When a QC solution is registered, data about the solution is saved on the analyzer. The
data is necessary to evaluate QC results. For example, to make sure that the result
falls within the specified control range and mark the results that do not. It is only
necessary to register a specific lot of a QC solution one time.

About registration of QC solutions

QC measurement About registration of the QC solutions used

type

Built-in QC measure- The QC solutions are automatically registered when the Solution Pack is
ments installed. A chip on the Solution Pack supplies data about the solutions.

Ampoule-based QC Each lot of each level of QC solution must be manually registered before
measurements use. This applies to Radiometer and non-Radiometer QC solutions.

The ABL90 FLEX barcode on the product insert for each level of Radio-
meter QC solution supplies data about it. The data is saved on the
analyzer and used when ampoule-based QC measurements are done
with the solution.

To register a Radiometer QC solution for ampoule-based QC

measurements

Prerequisite(s)
• The product insert (the document supplied with the QC solution)

You must register each level of each lot of QC solution before you can use them.

1. Tap Menu > Utilities > Setup > QC setup > QC solutions.
2. WARNING – Risk of data loss
Select a Slot that contains no data. If you select a slot that contains data, all stat-
istical data related to the QC solution registered in the slot will be irreversibly
deleted.
NOTE: The number of the slot can be thought of as a registration number.
3. Scan or enter the barcode for the ABL90 FLEX PLUS analyzer from the product
insert.
4. Tap the Close button.

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Post-requisite: If local, state or federal regulations require it, establish analyzer-specific

control ranges.

Data saved during registration of Radiometer QC solutions

During registration the barcode for the ABL90 FLEX PLUS analyzer is scanned from the
product insert. The screen shows the data that is read from the barcode and saved on
the analyzer.

1 Slot 1 – The slot number tells the 5 Insert range – The control range
analyzer where data for the specific given on the product insert for the
lot of the QC solution is stored ABL90 FLEX PLUS analyzer

2 The generic name of the QC solu- 6 Assigned Value – The center

tion – The character S followed by value of the Insert range
a four digit number. For example,
S7750.

3 Lot: – The lot number of the QC 7 Control range – By default, the

solution control range is given the same
values as the Insert range.
4 Parameter – The parameters that
can be measured NOTE: If local, state or federal
regulations require it, control
ranges can be changed to
analyzer-specific control ranges
established by your laboratory.

Related information
How to establish analyzer-specific control ranges, page 190

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To register a non-Radiometer QC solution

Prerequisite(s)
• Control ranges for the parameters to be measured with the QC solution are avail-
able

NOTE: If non-Radiometer QC solutions are used, Radiometer cannot guarantee accu-

rate, valid QC results.
NOTE: Results of QC measurements done with non-Radiometer QC solutions are not
automatically temperature corrected.

1. Tap Menu > Utilities > Setup > QC setup > QC solutions.
2. Select a Slot that contains no data.
NOTE: The number of the slot can be thought of as a registration number.
3. Tap the Add non-R- button.
4. Write down the number of the Slot. The number is necessary in step 7 of this
procedure.
5. Tap the Close button.
6. Tap Menu > Utilities > Setup > QC setup > QC ranges.
7. Tap the Next slot button to select the number of the slot you wrote down in step
4.
8. Tap the Edit button.
9. Enter values for the Current control range of the parameter shown on the
screen.
10. Tap the Next param．button to select the next parameter.
11. Enter values for the Current control range of the parameter shown on the
screen.
12. Do steps 10 and 11 again for all parameters.
13. Tap the Back > Close buttons.

Data saved during registration of non-Radiometer QC solutions

Here is the data that can be saved during registration of a non-Radiometer QC solu-
tion:
• Generic name Non-R-
• Control range for each parameter

Quality control solutions

To set up the temperature field for QC measurements

NOTE: QC results are temperature dependent. That is why there is a Temperature

field in the Quality control identification screen that is shown during ampoule-based
QC measurements.

This procedure lets you make it mandatory to enter the room temperature in Temper-
ature field, or set a default value in the field.
NOTE: If necessary, a set default temperature can be changed during an
ampoule-based QC measurement.

1. Tap Menu > Utilities > Setup > QC setup > QC input setup.

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2. Choose an option and follow the steps for it.

Option Steps

To make the Temperature field mandatory. Select the Mandatory

temperature: check button.
NOTE: When this option is chosen, operators
must enter the room temperature before QC
results are shown.

To set a default temperature Enter a temperature in the

Default temperature: field.
3. Tap the Close button.

Scheduled QC measurements

To schedule ampoule-based QC measurements

Prerequisite(s)
• The QC solution is registered

1. Tap Menu > Utilities > Setup > QC setup > QC schedule.
2. Tap the Add button.
3. Select the registered QC solution, on the right of the screen.
4. Tap the Select button.
5. Enter a start time.
6. Select a value for the Repeat: field, on the right of the screen.
7. If you selected a value less than 24 hours in step 6, select check buttons for the
days of the week QC measurements must be done.
8. Tap the OK button.
9. Tap the Close button.

To edit the schedule for ampoule-based QC measurements

1. Tap Menu > Utilities > Setup > QC setup > QC schedule.
2. Select the scheduled measurement you want to edit. Scheduled ampoule-based
measurements are marked by diamond-shaped icons.

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3. Choose an option and follow the steps for it.

Option Steps

To only delete the selected a) Tap the Delete button.

scheduled measurement b) Tap the Event for this day.

To delete all measurements a) Tap the Delete button.

with the selected solution that b) Tap the Event for all days.
are scheduled at this time of
the day

To delete all scheduled meas- a) Tap the Delete button.

urements with the selected b) Tap the All entries for QC slot <n>.
solution
NOTE: <n> is a number.

To change the days of the week a) Tap the Edit button.

measurements must be done b) Tap in the Weekdays: field.
c) Select the check buttons for the days of the
week measurements must be done.
d) Tap the OK button.

To change the start time for a) Tap the Edit button.

measurements b) Tap the Start time: field.
c) Enter a new start time.
d) Tap the OK button.

To change how frequently a) Tap the Edit button.

measurements must be done b) Tap the Repeat: field.
c) Select a value from the field on the right of
the screen.
d) Tap the OK button.
4. Tap the Close button.

Built-in QC measurement frequency

A built-in QC measurement is scheduled by default to be done every 8 hours. One

measurement a day is done with each QC solution. Built-in QC measurements are also
scheduled by default to be done in connection with these activities:

• Replacement of the Solution Pack

• Replacement of the Sensor Cassette
• Startup

You can edit the schedule for built-in QC measurements.

To edit the schedule for built-in QC measurements

Prerequisite(s)
• The schedule for built-in QC measurements is not linked to the calibration schedule

1. Tap Menu > Utilities > Setup > QC setup > QC schedule.
2. Select the scheduled built-in QC measurement you want to edit. Scheduled built-in
QC measurements are marked by diamond-shaped icons and stars.
NOTE: Built-in QC measurements are done with QC solutions registered in slots A,
B and C.

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3. Choose an option and follow the steps for it.

Option Steps

To restore the default setup for Tap the Reset Built-in QC button.
scheduled built-in QC measure-
ments

To only delete the selected a) Tap the Delete button.

scheduled measurement b) Tap the Event for this day.

To delete all measurements a) Tap the Delete button.

with the selected solution that b) Tap the Event for all days.
are scheduled at this time of
the day

To delete all scheduled meas- a) Tap the Delete button.

urements with the selected b) Tap the All entries for QC slot <n>.
solution

To change the days of the week a) Tap the Edit button.

measurements must be done b) Tap in the Weekdays: field.
c) Select the check buttons for the days of the
week measurements must be done.
d) Tap the OK button.

To change the start time for a) Tap the Edit button.

measurements b) Tap the Start time: field.
c) Enter a new start time.
d) Tap the OK button.

To change how frequently a) Tap the Edit button.

measurements must be done b) Tap the Repeat: field.
c) Select a value from the field on the right of
the screen.
d) Tap the OK button.

To schedule built-in QC meas- This is the default setting. Radiometer recom-

urements to be done after mends that you do not change this setting.
replacement and startup proce-
dures

To remove built-in QC meas- Radiometer recommends that you do not use

urements after replacement this option.
and startup from the schedule
Deselect the Run built-in QCs after replace-
ment and startup check button.
NOTE: If this option is selected, Radiometer
recommends that you do ampoule-based QC
measurements after replacement and startup
procedures.

4. Tap the Close button.

5. If a pop-up screen is shown, choose an option and follow the steps for it.
Option Steps

To accept the new schedule Tap the Accept button.

To change the schedule • Tap the Back button.

• Do steps 3 to 5 again.

Related information
To link the built-in QC schedule to the calibration schedule, page 176

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To request ampoule-based QC measurements after replacements

This procedure lets you set up the analyzer to request ampoule-based QC measure-
ments after Sensor Cassette and/or Solution Pack replacements. The analyzer will be
locked until the ampoule-based QC measurements are done.

1. Tap Menu > Utilities > Setup > QC setup > QC solutions.
2. Select the QC solution to be used for an ampoule-based QC measurement.
3. Choose an option and follow the steps for it.
Option Steps

To request ampoule-based QC meas- a) Select the Request QC after Solu-

urements after Solution Pack replace- tion Pack replacement check
ments button.

To request ampoule-based QC meas- a) Select the Request QC after Sensor

urements after Sensor Cassette Cassette replacement check
replacements button.
4. Do steps 2 and 3 again for each QC solution to be used for an ampoule-based QC
measurement after a replacement.
5. Tap the Close button.

Corrective actions on QC results

To set up corrective action for errors in QC results

Three corrective actions are available to show errors in QC results.

• Attach a question mark symbol to patient results until the QC error is removed
• Select the color of traffic light shown on the left side of the Quality control button
in the Analyzer status screen.
• Do not show patient results for parameters with QC or other errors. See Related
information.
NOTE: A successful QC measurement can remove the error.

1. Tap Menu > Utilities > Setup > General setup > Corrective actions.
2. Select the condition “QC error(s) present”.
3. Choose an option and follow the steps for it.
Option Steps

To change the traffic light color a) Make sure the ? on specific parameters
check button is deselected.
b) Tap the traffic light symbol until it shows the
color you want.

To attach a question mark Select the ? on specific parameters check

symbol to patient results button.
NOTE: This option will also set the traffic light
color to yellow.

4. Tap the Close button.

Related information
To repress a parameter, page 169

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To set up corrective actions for overdue scheduled QC measurements

Three corrective actions are available to show that scheduled QC measurements are
overdue.
• Select the color of traffic light shown on the left side of the Quality control button
in the Analyzer status screen.
• Attach a message about overdue QC measurements to all patient results until the
measurements are successfully completed.
• Lock the analyzer
NOTE: When the analyzer is locked, no patient samples can be analyzed until
overdue scheduled QC measurements are successfully completed.

1. Tap Menu > Utilities > Setup > General setup > Corrective actions.
2. Select the condition “QC schedule reminder(s)”.
3. Choose the option you want and follow the steps for it.
Option Steps

To change the traffic light color Tap the traffic light symbol until it shows the
color you want.

To attach a message to subse- Select the Message on next patient result

quent patient results check button.

To lock the analyzer Select the Lock analyzer when QC overdue

check button.
4. Tap the Close button.

To apply operator-defined corrections to QC results

Operator-defined corrections refer to corrections made to the offset and slope for
parameters.

1. Tap Menu > Utilities > Setup > General setup > Miscellaneous setup.
2. Select the Apply parameter corrections to QC check button.
3. Tap the Close button.

Related information
Limits for slope and offset values, page 172

To set up corrective action for errors in built-in QC measurements

This procedure lets you set up the analyzer to do built-in QC measurements again
when there are errors in the built-in QC results.

1. Tap Menu > Utilities > Setup > General setup > Corrective actions.
2. Select the condition “Built-in QC error(s) present”.
3. Select the Rerun same level once check button.
4. Tap the Close button.

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QC statistics

To set up automatic print of built-in QC statistics

This procedure lets you set up the analyzer to automatically print QC statistics for
built-in QC when you start to use a new lot of a QC solution.

1. Tap Menu > Utilities > Setup > QC setup > QC statistics.
2. Select the check button in the Built-in QC frame.
3. Tap the Close button.

Statistical factor

The statistical factor expands the control range to the statistical range, which is the
range within which QC results must fall to be included in QC statistics.

NOTE: The statistical range = [Control range] × [Statistical factor]. Only QC results
that fall within the statistical range are included in QC statistics.

To set the statistical factor

1. Tap Menu > Utilities > Setup > QC setup > QC statistics.
2. If necessary, enter a new value In the Statistical factor used for value accept-
ance field.
NOTE: The default value is 1.5.
3. Tap the Close button.

Westgard Rules

About Westgard Rules

Westgard Rules are a set of control rules that can be applied to QC results to help you
do two things:
• Find errors in QC results. The symbol “W” is used to show when QC results have
violated applied Westgard Rules.
• Find shifts or trends in QC results. This helps you assess the quality and validity of
patient sample analyses.

Types of Westgard Rule

There are two types of rule.

• Warning rules. Rule 12s is the only warning rule.

• Rejection rules. Rules 13s, 22s, R4s, 41S and 10x are rejection rules.

Description of the lines used in Westgard rule illustrations

Line type Description

.......... Shows ±3 SD ranges

___ Shows control ranges (±2 SD)

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Line type Description

_____ Shows the mean value

Westgard rules and corrective actions

The Westgard rules 1:3s, 2:2s and R:4s can be applied to built-in and ampoule-based
QC results. Rule 4:1s and Rule 10x can only be applied to ampoule-based QC results.

Rule 1:2s (also written 12s) is a warning rule.

Westgard rule 12s Corrective action

The QC result Do a new measurement with QC material of

falls outside the same type, level and lot number.
the mean ±2 • If the new result does not fall outside the
SD range mean ±2 SD range, the original QC result
can be attributed to normal statistical
variation.
• If the new result falls outside the mean ±2
SD range, do what is necessary to be in
compliance with your local QC regulations.

Rule 1:3s (also written 13s) is a rejection rule.

Westgard rule 13s Corrective action

The QC result Do a new measurement with QC material of

falls outside the same type, level and lot number.
the mean ±3 • If the new result does not falls outside the
SD range mean ±3 SD range, the original QC result
can be attributed to normal statistical
variation.
• If the new result falls outside the mean ±3
SD range, do what is necessary to be in
compliance with your local QC regulations.

Rule 2:2s (also written 22s) is a rejection rule.

Westgard rule 22s Corrective action

Two consecu- Do what is necessary to be in compliance with

tive QC results your local QC regulations.
fall outside
and on the
same side of
the mean ±2
SD range

Rule R:4s (also written R4s) is a rejection rule.

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Westgard rule R4s Corrective action

The difference Do what is necessary to be in compliance with

between two your local QC regulations.
consecutive
QC results is
greater than 4
SD

This indicates that there is

inconsistency in your QC
procedures or your analyzer is
not stable.

Rule 4:1s (also written 41s) is a rejection rule.

Westgard rule 41s Corrective action

Four consecu- Do what is necessary to comply with your local

tive QC results QC regulations.
are on the
same side of NOTE: This rule can only be applied to
the mean ±1 ampoule-based QC results. Radiometer recom-
SD mends that this rule is only applied if the
parameter control ranges have been changed
This indicates a trend or shift. to analyzer-specific control ranges calculated
from a minimum of 20 ampoule-based QC
measurements.

Rule 10:x (also written 10x) is a rejection rule.

Westgard rule 10x Corrective action

Ten consecu- Do what is necessary to comply with your local

tive QC results QC regulations.
are on the
same side of NOTE: This rule can only be applied to
the mean ampoule-based QC results. Radiometer recom-
mends that this rule is only applied if the
parameter control ranges have been changed
This indicates a trend or shift. to analyzer-specific control ranges calculated
from a minimum of 20 ampoule-based QC
measurements.

To set up and enable Westgard Rules

This procedure lets you setup and enable Westgard Rules for selected QC solutions.
The rules can be set up for built-in QC solutions and ampoule-based QC solutions.

1. Tap Menu > Utilities > Setup > QC setup > Westgard Rules.
2. Make sure that there is a checkmark on the On/Off button. If there is no check-
mark, tap the button.
3. Tap the Next slot button to select the QC solution.

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4. Choose an option and follow the steps for it.

Option Steps

To apply all Westgard a) Tap the Select all button.

rules to QC results for
all parameters. NOTE: Rule 4-1S and 10-X cannot be applied to QC
solutions in slot A, slot B or slot C.
b) Tap the Continue button.

To apply some West- a) Select a parameter.

gard rules to QC b) Tap the Edit button.
results of some
parameters c) Select the check buttons of the rules you want to
apply.
d) If necessary, tap the Next param or Prev param
button to select a new parameter and do step c)
again.
5. Tap the Back > Close buttons.

To disable/enable Westgard rules

Prerequisite(s)
• Westgard rules are set up

This procedure lets you disable/enable the Westgard rules that are set up on all QC
solutions.

1. Tap Menu > Utilities > Setup > QC setup > Westgard Rules.
2. Choose an option and follow the steps for it.
Option Steps

To disable Westgard rules Deselect the On/Off check button.

To enable Westgard rules Select the On/Off check button.

3. Tap the Close button.

RiLiBÄK rules

About RiLiBÄK rules

RiLiBÄK rules are guidelines of the German Federal Medical Council. The rules provide
minimum requirements for the quality of quantitative test results in medical laborato-
ries.

To add a new RiLiBÄK rule

This procedure lets you add a new rule.

1. Tap Menu > Utilities > Setup > QC setup > RiLiBÄK ranges.
2. Tap the Add button.
3. Select the parameter you want.
4. Tap in the first Lower limit: field.
5. Enter the value of the lower limit.
6. Tap in the second Lower limit: field.
7. Tap < or <=.

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8. Tap in the first Upper limit: field.

9. Tap < or <=.
10. Tap in the second Upper limit: field.
11. Enter the value of the upper limit.
12. Choose an option and follow the steps for it.
Option Steps

To use a percentage to calculate the • Select the +/- Ranges [%] radio
acceptable deviation from the assigned button.
value. The assigned value is the center
• Enter the percentage value in the
value of the range you entered in step
5 and step 11. Ranges: field.

NOTE: This is the option most

frequently chosen.

To use an absolute value to calculate • Select the +/- Ranges radio

the acceptable deviation from the button.
assigned value
• Enter the absolute value in the
Ranges: field.
13. Tap the Back button.
14. Do steps 2 to 13 again for each rule you want to add.
NOTE: More than one rule can be added for a parameter if the ranges for each
rule do not overlap.
15. Tap the Close button.

To apply all RiLiBÄK rules

Prerequisite(s)
• RiLiBÄK rules are set up

This procedure lets you apply all the RiLiBÄK rules that are set up. You cannot select
which rules to apply.

1. Tap Menu > Utilities > Setup > QC setup > RiLiBÄK ranges.
2. Make sure there is a check mark on the On/Off button. If there is no check mark,
tap the button.
3. Tap the Close button.

To edit a RiLiBÄK rule

1. Tap Menu > Utilities > Setup > QC setup > RiLiBÄK ranges.
2. Select the rule you want to edit.
3. Tap the Edit button.
4. Edit the values.
5. If necessary, choose an option and follow the steps for it.
Option Steps

To use a percentage to calculate the • Select the +/- Ranges [%] radio
acceptable deviation from the assigned button.
value.
• Enter the percentage value in the
NOTE: This is most frequently used. Ranges: field.

To use an absolute value to calculate • Select the +/- Ranges button.

the acceptable deviation from the • Enter the absolute value in the
assigned value.
Ranges: field.

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6. Tap the Back > Close buttons.

To remove a RiLiBÄK rule

1. Tap Menu > Utilities > Setup > QC setup > RiLiBÄK ranges.
2. Select the rule you want to delete.
3. Tap the Delete button.
4. Tap the Close button.

Analyzer-specific control ranges

About analyzer-specific control ranges

If local, state or federal regulations require your laboratory to establish and use
analyzer-specific control ranges for the QC solutions used for ampoule-based QC meas-
urements, it can be done.

The analyzer-specific control ranges established in your laboratory must then be used
to replace the default Control range values given to parameters when QC solutions
are registered for use. The default values are the control ranges given on the product
insert. These values are shown in the Insert range column of the Quality control
ranges setup screen.

The control range values given in the insert are not analyzer-specific. They were estab-
lished as follows: QC measurements were done on a number of ABL90 FLEX PLUS
analyzers. Different lots of QC solution were used. Measurements were done by
different operators, over several days. Different Solution Packs were also used to take
lot-to-lot variations of calibration solutions into account.

How to establish analyzer-specific control ranges

Establishment of analyzer-specific control ranges is a 3-stage process:

• Stage 1: Do 20 ampoule-based QC measurements with each level of QC solution.
• Stage 2: Enable the use of Fixed SD values to parameters to make sure that the
lot-to-date ranges calculated in stage 3 are not made too narrow.
• Stage 3: Use the analyzer to change control ranges to lot-to-date ranges.

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Stage 1: To do 20 ampoule-based QC measurements

Prerequisite(s)
• Radiometer QUALICHECK5+ quality control solutions are registered for use
• The QC ampoules are prepared for use
• Make sure that the analyzer is Ready

NOTE: This procedure is only necessary if local, state and federal regulations require
you to do ampoule-based QC measurements that are based on analyzer-specific
control ranges established by your laboratory.

Radiometer recommends that measurements done in this procedure are done by more
than one person over a period of 4-5 days. This will take into account
sample-to-sample, operator-to-operator and day-to-day variations.

1. Do a minimum of 20 ampoule-based QC measurements with each level of QC solu-

tion.

Related information
To prepare a Radiometer QC ampoule for use, page 63
Data saved during registration of Radiometer QC solutions, page 178

Stage 2: To enable the use of fixed standard deviations

You can use this procedure to make sure that the analyzer-specific control ranges
calculated in stage 3 of the process are not made too narrow. The Fixed SD values
enabled for use during this procedure are only used when they are found to be greater
than the calculated standard deviations of the measurements made in stage 1 of the
process.

1. Tap Menu > Utilities > Setup > QC setup > QC ranges.
2. Tap the Next slot button to find the QC solution you want to edit.
3. Select the parameter.
4. Tap the Edit button.
5. Select the check button in the Fixed SD field.
NOTE: The value shown is a Radiometer value.
6. Tap the Next param . or Prev param．button to select a new parameter.
7. Select the check button in the Fixed SD field.
8. Do steps 6 and 7 again for each parameter.
9. Tap the Back > Close buttons.

Stage 3: To use the analyzer to change control ranges to

analyzer-specific control ranges

NOTE: Radiometer recommends that you do Stage 1 and 2 of the process before you
do stage 3.

The analyzer uses all successful QC results to calculate the mean value and standard
deviation (SD) values of parameters. The lot-to-date range is calculated as follows:

Lot-to-date range = [Mean value] ± [2 × calculated SD value]

The analyzer then updates the Control range of parameters. It compares the calcu-
lated SD values with the Fixed SD values that were enabled for use in stage 2 of the
process.

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• If a [calculated SD value] > [Fixed SD value], the control range of the parameter is
changed to the lot-to-date range
• If a [calculated SD value] < [Fixed SD value], the control range of the parameter is
changed to the control range calculated as follows:

Control range = [Mean value] ± [2 × Fixed SD value].

This makes sure that the control ranges are not made too narrow.

1. Tap Menu > Utilities > Setup > QC setup > QC ranges.
NOTE: The number of successful QC measurements are shown in the N column.
2. Tap the Next slot button to find the QC solution you want to edit.
3. Tap the Update all button.
NOTE: The control ranges of all parameters are now analyzer-specific.
4. Tap the Back > Close buttons.

To manually change control ranges to analyzer-specific control

ranges

Prerequisite(s)
• Analyzer-specific control ranges have been established

NOTE: This procedure is only necessary if local, state and federal regulations require
you to do ampoule-based QC measurements that are based on analyzer-specific
control ranges established by your laboratory. The procedure lets to change the control
ranges manually.

1. Tap Menu > Utilities > Setup > QC setup > QC ranges.

2. Tap the Next slot button to find the specific lot and level of QC solution you want
to edit.
3. Select a parameter.

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4. Tap the Edit button.

5. Enter the values of the analyzer-specific control range in the Current control
range frame.
6. To change the control range of the other parameters, do as follows for each
parameter:
a) Tap the Next param．button.
b) Do step 5 again.
7. Tap the Back button.
NOTE: The entered values are shown in the Control range column of the Quality
control ranges setup screen.
8. Tap the Close button.

Maintenance setup
About mandatory and operator-defined activities

There are 2 types of maintenance activity:

• Mandatory – activities that must be done

• Operator-defined – activities that can be set up by operators

Mandatory maintenance activities

Other activities

Other activities are mandatory replacement activities that are scheduled or can be
scheduled to be run at regular intervals of time. For example, to clean the screen.

Other activities are shown in the Other activities part of the Analyzer status screen.
When a scheduled activity is due, a reminder is shown in the Analyzer status screen.

To schedule other activities

1. Tap Menu > Utilities > Setup > Replacement setup > Replacement
schedule.

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2. Select the activity in the Replacements column.

3. Tap the Edit button.
4. Select the frequency for the activity in the Interval field.
NOTE: The first date for the scheduled activity is shown in the Next date field.
The time is equal to the current date plus the number of days selected in the
Interval field.
5. Choose an option and follow the steps for it.
Option Steps

To change the first date for the sched- a) Tap in the Next date field.
uled activity b) Enter a new date.

To accept the first date for the sched- Go to the next step.
uled activity
6. Tap the Back > Close buttons.

To set up corrective action for overdue Other activities

Prerequisite(s)
• Other activities are scheduled

Three corrective actions are available to show that scheduled Other activities are
overdue.
• Select the color of traffic light shown on the left side of the Other activities button
in the Analyzer status screen.
• Attach a message about overdue scheduled activities to all patient results until the
activities are successfully completed.
• Lock the analyzer when a scheduled activity is more than 10 % overdue.
NOTE: When the analyzer is locked, no patient samples can be analyzed until
overdue scheduled activities are successfully completed.

For example: If an activity is scheduled to be done every 10 days and the activity is
not done [10 days + (10 % of 10 = 1) day] = 11 days after the activity was last
done, the analyzer locks.

1. Tap Menu > Utilities > Setup > General setup > Corrective actions.
2. Select the condition “Replacement schedule reminder(s)”.
3. Choose the option you want and follow the steps for it.
Option Steps

To change the traffic light color Tap the traffic light symbol until it
shows the color you want.

To attach a message to subsequent Select the Message on next patient

patient results result check button.

To lock the analyzer when the activity is Select the Lock analyzer when 10 %
more than 10 % overdue overdue check button.

Operator-defined activities

Operator activities

Operator activities are activities you can set up and schedule to be done at regular
intervals of time. For example, to clean the touch screen and analyzer exterior. When a
scheduled activity is due, a message is sent as a reminder to do the activity.

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To set up an operator activity

1. Tap Menu > Utilities > Setup > Replacement setup > Operator activities.
2. Tap the Add button.
3. Enter a name for the activity.
4. Select the frequency for the activity in the Interval field.
NOTE: The first date for the scheduled activity is shown in the Next date field.
The time is equal to the current date plus the number of days selected in the
Interval field.
5. Choose an option and follow the steps for it.
Option Steps

To change the first date for the sched- a) Tap in the Next date field.
uled activity b) Enter a new date.

To accept the first date for the sched- Go to the next step.
uled activity
6. Tap the Back > Close buttons.

To set up corrective action for pending operator activities

This procedure lets you set up the analyzer to change the color of the traffic light
shown on the left side of the Other activities button in the Analyzer status screen
to remind operators about pending operator activities.

1. Tap Menu > Utilities > Setup > General setup > Corrective actions.
2. Select the condition “Operator activity reminder(s)”.
3. Tap the button with the traffic light symbol to select the color you want to show.
4. Tap the Close button.

To delete an operator activity

1. Tap Menu > Utilities > Setup > Replacement setup > Operator activities.
2. Select the activity.
3. Tap the Delete button.
4. Tap the Continue button.
5. Tap the Close button.

Maintenance planning

To plan maintenance activities

This procedure lets you enter the periods of time that people who maintain the
analyzer are available each day. The analyzer uses this information to send reminders
about maintenance activities so they can be done when people who maintain the
analyzer are available. This procedure can be used to decrease analyzer down time.

1. Tap Menu > Utilities > Setup > Replacement setup > Maintenance plan-
ning.
2. Select the check button for the days that people who maintain the analyzer are
available.
3. Enter the start and end time that people who maintain the analyzer are available.
4. Tap the Close button.

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Replacement warnings

To set up replacement warnings

Replacement warnings are messages that can be set up to tell operators that installed
consumables (Solution Pack/Sensor Cassette) will soon have to be replaced. You can
set up two conditions to cause a message to be sent.
• the number of remaining activities/tests falls below a selected value
• the number of hours that remain before a consumable expires falls below a selected
value

1. Tap Menu > Utilities > Setup > Replacement setup > Replacement warn-
ings.
2. Select a number in the Expected measurements per day field, so the analyzer
can calculate the most probable replacement date.
3. Select a number in the Number of tests before replacement warning field.
4. Select a time period in the Time before replacement warning field.
5. Tap the Close button.

Note fields

To create standard texts for use in Note fields

1. Tap Menu > Utilities > Setup > General setup > Parameters and input >
User-defined notes.
2. Select the check button for the screen where you want standard text to be avail-
able for use in the Note field.
3. Tap the Add button.
4. Enter the standard text.
5. Do steps 3 and 4 again for each standard text you want to add.
6. Tap the Close button.

To edit standard texts for use in Note fields

1. Tap Menu > Utilities > Setup > General setup > Parameters and input >
User-defined notes
2. Select the note you want to edit.
3. Tap the Edit button.
4. Edit the note.
5. Tap the Close button.

To delete standard texts for use in Note fields

1. Tap Menu > Utilities > Setup > General setup > Paramters and input >
User-defined notes.
2. Select the note you want to delete.
3. Tap the Delete button.
4. Tap the Close button.

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Communications

Data security

Only original software specifically intended for the ABL90 FLEX PLUS analyzer and
made available through Radiometer must be installed on the analyzer. It is not
permitted to install third party software of any kind on the ABL90 FLEX PLUS analyzer.
The Radiometer DMS software can run on Windows 7, Windows 10, or Windows 10
with Application Control.

In order to protect against unauthorized access to the analyzer's operating system,

ensure that access to system keys is disabled when leaving the service programs.

To secure patient data transmitted from an analyzer to a LIS/HIS or AQURE/RADIANCE

system against unauthorized access and modification, Radiometer recommends the use
of a VPN connection. For WiFi connections Radiometer recommends the use of security
protocol WPA2 to ensure WiFi authentication and the encryption setting AES to ensure
that WiFi is encrypted.

Radiometer recommends using a low-level parity check for serial connections.

When using WiFi, ensure that WLAN coverage is adequate for all positions of the ABL90
FLEX PLUS analyzer, and coverage is not disturbed by radio frequency interference.

Note: It is the customer's responsibility to make sure all valuable data is backed up
regularly.

Data security and user management

In order to prevent unauthorized access to patient data, Radiometer recommends that

either the built-in operator management feature or the centralized user management
from AQURE/RADIANCE system is enabled and maintained.

If the Automatic log off option is disabled, operators will not be logged off after using
the analyzer. Configure the analyzer to keep the Automatic log off option enabled.
This will disable patient data access and prevent unintended or unauthorized access.

If the analyzer is to be controlled by a remote operator, ensure that access to patient

data is disabled for this remote operator, and that the analyzer will log off the remote
operator when the inlet is opened.

Contact your local Radiometer representative for more information.

LIVE Connect

This feature allows external service of the analyzer and is for use by Radiometer
service personnel. It provides a network connection to send analyzer data to Radio-
meter (Data Acquisition) and/or to enable External remote support.

• Data Acquisition – sends analyzer data to Radiometer for pro-active monitoring

and support of the analyzer. For patient privacy, patient information is not trans-
mitted.
• External remote support – provides the ability for a Radiometer service represen-
tative to manage and service the analyzer remotely. For patient privacy, patient logs
are not accessible by the remote operator.

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To set up a LIS/HIS connection

Prerequisite(s)
A connection to a network is available

1. Tap Menu > Utilities > Setup > General setup > Communications >
LIS/HIS connection.
2. Tap the Add button.
3. Enter a name for the connection.
4. Tap the Back button.
5. Select the high-level protocol used by the LIS/HIS system.
6. Choose an option and follow the steps for it.
Option Steps

To set up a serial low-level protocol a) Select a serial setting.

b) Tap the Edit button.
c) Tap the Edit button again.
d) If necessary, change the settings.
e) Tap the Back > Back > Close buttons.

To set up a network low-level a) Select a network setting.

protocol b) Tap the Edit button.
c) If necessary, change the settings.
d) Tap the Back > Close buttons.

To set up a AQURE/RADIANCE connection

1. Tap Menu > Utilities > Setup > General setup > Communications >
AQURE/RADIANCE connection.
2. Enter the address of the AQURE/RADIANCE server the analyzer is connected to.
3. Enter the number of the AQURE/RADIANCE server port the analyzer is connected
to.
4. Enter the password the analyzer was given to access the AQURE/RADIANCE
system.
5. Select the Communicate with AQURE/RADIANCE checkbox.
NOTE: The status “Connected” is shown in the Connection status frame.
6. Tap the Close button.

At the bottom of the analyzer screen the icon shows if there is a connection or not:

Icon Explanation

There is a connection between the system and the analyzer

There is no connection between the system and the analyzer

Patient data from a LIS/HIS or AQURE/RADIANCE system

Patient data can be downloaded to the analyzer from a connected LIS/HIS or

AQURE/RADIANCE system.

You can set up the analyzer to request patient data automatically from the system, or
let operators request patient data manually. There are 2 options for manual requests:

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• Fill in the Accession number, Patient ID or Sampler ID field in the Patient

identification screen and request the patient data.
• Fill in the Patient department field in the Patient identification screen, lookup,
find and request the patient data.
NOTE: To use this option, you must enable patient lookup.

To set up automatic requests for patient data

Prerequisite(s)
• A connection is set up to the LIS/HIS or AQURE/RADIANCE system that patient data
is to be requested from

1. Tap Menu > Utilities > Setup > General setup > Communications > Auto-
matic data request.
2. Select the connection to the system that patient data is to be requested from.
3. In the Request patient demographics frame, select the check button for the
data field in the Patient identification screen that when filled in will automati-
cally request patient data from the system.
NOTE: It is possible to select more than one check button, but Radiometer recom-
mends that you only select one.
4. Tap the Close button.

To set up automatic transmission of data to a system

Prerequisite(s)
• A connection is set up to the LIS/HIS and/or AQURE/RADIANCE system that data is
to be sent to

1. Tap Menu > Utilities > Setup > General setup > Communications > Auto-
matic data transmission.
2. Select the name of the connection.
3. Select the check buttons for the data to be automatically sent.
4. Do steps 2 and 3 again for each system that you want to transmit data to.
5. Tap the Close button.

To enable manual patient data requests using Patient lookup

Prerequisite(s)
• If data is to be requested from an LIS/HIS or AQURE/RADIANCE system, a connec-
tion must be set up to the system
• The selected Patient report contains the Department (Pat.) field

Patient data can be requested from the analyzer database, a connected LIS/HIS or
AQURE/RADIANCE system.

This procedure lets operators request patient data manually, via a Patient lookup
button, after they have filled in the Department (Pat.) field of the Patient identifi-
cation screen.

1. Tap Menu > Utilities > Setup > General setup > Communications > Patient
lookup setup.
2. Select the name of the connection.
3. Select the number of days after patient data is saved in the Patient profiles log
that it must be available for use. The default is 7 days.
4. Tap the Close screen.

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Printers

To set up automatic printing

1. Tap Menu > Utilities > Setup > General setup > Printers > Automatic
printing.
2. Select the check buttons for the data you want to be printed automatically.
NOTE: If you select the QC results check button, built-in and ampoule-based QC
measurement results will be printed.
3. Select the number of copies of patient results that must be printed.
4. Tap the Close button.

To install an external printer for the analyzer

This procedure must be done by your local Radiometer representative.

1. Tap Menu > Utilities > Setup > General setup > Printers > Printer setup.
2. Tap the Install printer button and follow the instructions shown on the screen.
3. If necessary, tap the Edit name button and enter the new name.
4. Do step 2 and 3 again for each printer you want to install.
NOTE: Radiometer recommends that a maximum of 10 printers are installed.
5. Choose an option and follow the steps for it.
Option Steps

To print data on the same a) Select the printer.

printers each time b) Tap the Select/deselect button.
c) Make sure a check mark is shown adjacent
to the printer name.
d) Do steps a) to c) again for each printer.

To get a list of the installed Select the check button in the Manual printing
printers before you print data frame.

To print data on all installed Make sure that the check button in the Manual
printers printing frame is deselected.
6. Tap the Close button.

To edit the name of a printer

1. Tap Menu > Utilities > Setup > General setup > Printers > Printer setup.
2. Select the printer.
3. Tap the Edit name button, and enter the new name.
4. Tap the Close button.

Data logs and archives

About data logs and archived data logs

The analyzer can be set up to automatically save data logs to archives on the analyzer
or on an external device. Data is moved to the archives when the data logs are full.

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You can export data logs and archived data logs manually and save them on an
external device. You can also import archives from other ABL90 FLEX PLUS analyzers.

To set up automatic archiving

1. Tap Menu > Utilities > Setup > General setup > Disk functions setup >
Automatic archiving.
2. Select the check buttons for the data logs that you want to be archived.
3. Choose an option and follow the steps for it:
Option Steps

To archive the data logs on the a) Select the Store archives on the analyzer
analyzer check button.
b) Tap the Close button.

NOTE: The data is saved on the D: drive.

To archive the data logs to a a) Deselect the Store archives on the

different destination analyzer check button.
b) Select an external drive.
c) Tap the button with the folder icon.
d) Select the folder where the data logs must
be archived.
e) Tap the Back > Close buttons.

File format of exported data logs and archived data logs

Data logs can be exported as compressed Comma Separated Value (CSV) files. The
CSV files can be read by database and spreadsheet programs. For example: Microsoft
Excel, Access and Lotus 1-2-3.

However, archived data logs can also be exported as .bin files. The .bin files are
encrypted. If you want to read them, you must import them to the analyzer.

To export data logs

This procedure lets you export one or more data log from the analyzer in .csv format.
NOTE: Data logs are not removed from the analyzer during this procedure. The
exported data logs are only copies.

1. Make sure that there is a connection between the analyzer and the device to which
the logs are to be exported.
2. Tap Menu > Utilities > Disk functions > Export data logs.
3. Deselect the check buttons for the data logs that you do not want to export.
4. Tap the button with the calendar icon in the Date interval frame.
5. Enter a date in the From: and To: fields.
6. Tap the Back button.
7. Tap the check button on the right side of the Directory: field.
8. Select the folder on the external drive you want to export the data logs to.
9. Tap the Back button.
10. Tap the Start button.
11. Tap the Start button.

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To export data from Archived data logs

This procedure lets you export part of an archived data log from the analyzer in .csv
format.

1. Make sure that there is a connection between the analyzer and the device to which
the archive is to be exported.
2. Tap Menu > Data logs > Archived data logs.
3. Select the archive type.
4. Select a date interval.
5. Tap the Export archive button.
6. Select the folder on the external drive that you want to export the archived data
log to.
7. Tap the Back button.
8. Tap the Start button.

To create disc space by exporting and deleting archives

This procedure lets you export archives to an external system and then delete them
from the analyzer database to create space. The files are moved in .bin format. They
cannot be read by database or spreadsheet programs. They must be imported to the
analyzer to be read.

1. Make sure that there is a connection between the analyzer and the device to which
the archive parts are to be exported.
2. Tap Menu > Utilities > Disk functions > Import / Export archives.
3. Select the archive type.
4. Select an archive.
5. Tap the button with the folder icon in the Source/Destination: frame.
6. Select the folder to export the archive to.
7. Tap the Back button.
8. Tap the Export button.
9. In the Archives stored on analyzer: frame:
a) Select the archive that you selected in step 4 and have just exported.
b) Tap the Delete button.
10. Do steps 3 to 9 again for each archive you want to export and delete.
11. Tap the Close button.

To import archived data logs

1. Make sure that there is a connection between the analyzer and the device that
contains the archives.
2. Tap Menu > Utilities > Disk functions > Import / Export archives.
3. Select the archive type.
4. Tap the button with the folder icon in the Source/destination frame.
5. Select the folder that contains the archives you want to import.
6. Tap the Back button.
7. Select one of the archives in the Source/destination frame.
8. Tap the Import button.
9. If necessary, do steps 7 and 8 again.
10. Tap the Close button.

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Data backup and restoration

Backup

A backup includes all data logs and system files. Backup can be set up to be done
automatically. The backup can also be done manually.

If data is lost or damaged, the backup will restore most of the data and keep data loss
to a minimum.

NOTE: The customer must make sure that a backup is done regularly.

Destinations for backup data

A backup can be saved to these destinations:

• A USB flash drive
• A folder on an external network drive

To schedule automatic backups

1. Create a folder for the backup on the device on which the backup is to be saved.
2. Make sure that there is a connection between the analyzer and the device.
3. Tap Menu > Utilities > Setup > General setup > Disk functions setup >
Automatic backup.
4. Select the Automatic backup of all data- and system files check button.
5. Enter the time.
6. Enter the number of days between subsequent backups.
7. Tap the button with the folder icon.
8. Select the folder where the backup is to be saved.
9. Tap the Back > Close buttons.

To do a manual backup
1. Create a folder for the backup on the device on which the backup is to be saved.
2. Make sure that there is a connection between the analyzer and the device.
3. Tap Menu > Utilities > Disk functions > Backup all data.
4. Tap the Change destination button.
5. Select the folder where the backup is to be saved.
6. Tap the Back button.
7. Tap the Start button.
8. Look at the screen. A message will tell you when the backup is done.
NOTE: A message is shown on the screen if the backup cannot be done.
9. Tap the Close button.

To restore data from a backup

Prerequisite(s)
• The latest backup is available

1. Make sure that there is a connection between the analyzer and the device that
contains the backup.
2. Tap Menu > Utilities > Disk functions > Restore all data.
3. Tap the Change source button.

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4. Select the folder that contains the backup.

5. Tap the Back button.
6. Tap the Start button.
NOTE: When data is restored, the analyzer shuts down and restarts.

Saving and loading setups

To save the setup

1. Create a folder for the setup on the device on which the setup is to be saved.
2. Make sure that there is a connection between the analyzer and the device on
which the setup is to be saved.
3. Tap Menu > Utilities > Disk functions > Save setup.
4. Tap the Edit location button.
5. Select the folder where the setup is to be saved.
6. Tap the Back button.
7. Tap the Start button.
8. Wait until a message tells you that the setup is saved.
9. Tap the Close button.

To load a setup
1. Make sure that there is a connection between the analyzer and the device from
which the setup is to be loaded.
2. Tap Menu > Utilities > Disk functions > Load setup.
3. Choose an option and follow the steps for it.
Option Steps

To load all parts of the setup Select the All check box.

To load one or more parts of a) Deselect the All check box.

the setup b) Select the check boxes of the setups you
want to load.
4. Tap the Change source button.
5. Select the folder from which the setup is to be loaded.
6. Tap the Back button.
7. Tap the Continue button.
NOTE: The analyzer will shut down and restart with the new setup.

To restore Radiometer default settings

1. Tap Menu > Utilities > Disk functions > Restore default setup.
2. Choose an option and follow the steps for it.
Option Steps

To restore all default settings Select the All check box.

To restore one or more default a) Deselect the All check box.

settings b) Select the check boxes of the default
settings you want to restore.
3. Tap the Continue button.
NOTE: The analyzer will shut down and restart with the new setup.

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Radiometer default settings

Operators and profiles - default settings

Item Default setting

Operators Radiometer, Internal remote operator, External remote

operator, Manager

Access profiles All 10 access profiles reset to default settings

Logoff time 3 minutes

Anonymous access enabled Yes

Access profile for anonymous operator User

Authenticate operator by Logon-barcode as primary

Access profile Access to activities

A B C D E F G H I J K L M

Operator X X X X X X X X X X X X

Supervisor X X X X X X X X X X X X X

Manager X X X X X X X X X X X X X

Service technician X X X X X X X X X X X X X

Guest X X

Custom 1 X

Custom 2 X

Custom 3 X

Internal remote operator X X X X X X X X X X X X

External remote operator X X X X X X X X X X X X

Activity Description

A Perform measurements

B Perform calibrations

C Perform operator Activities

D Edit data in logs

E Start built-in QC

F Approve results

G Replace the Sensor Cassette

H Clean the Inlet Gasket

I Replace the Inlet Gasket Holder

J Replace the Solution Pack

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Activity Description

K Replace the Inlet Connector Gasket

L Flush the analyzer

M Replace the Inlet Probe

Alarm sound (acoustic signal) settings for events - default settings

Event Default setting

Value exceeds critical range No

Close inlet Yes

Result is ready Yes

Inlet is open too long Yes

Language - default setting

Item Default setting

Screen language English

Analysis setup – default settings

Analysis setup Default setting

Syringe sample modes • Syringe - S 65µL

NOTE: All user-defined modes are removed.

Capillary sample modes C 65µL

NOTE: All user-defined modes are removed.

Parameter profiles All parameters are selected.

Use dynamic parameters is off.

Sample pre-registration • Interpret barcode input as: Sampler ID

setup
• Included fields: Sampler ID, Patient first name, Patient last
name, Birth date, Patient sex, Accession no．

Sample age evaluation Enable calculation of sample age: Yes (30 minutes for all parame-
setup ters)

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Analysis setup Default setting

Patient report setup • Layouts: -R- Default

• Patient ID layout settings included in the -R- Default layout:

• Patient ID
• Patient last name
• Patient first name
• Sample type (Not specified)
• Temperature (T ), 37.0 °C
• Patient result settings included in the -R- Default layout (bold
text = a new title; [xxx - xxx] = the reference range for a
parameter)

Blood gas values

pH [xxx - xxx]

pCO2 [xxx - xxx]

pO2 [xxx - xxx]

<New line>

Oximetry values

ctHb [xxx - xxx]

sO2 [xxx - xxx]

FO2Hb [xxx - xxx]

FCOHb [xxx - xxx]

FHHb [xxx - xxx]

FMetHb [xxx - xxx]

FHbF [xxx - xxx]

<New group>

Electrolyte values

cK+ [xxx - xxx]

cNa+ [xxx - xxx]

cCa2+ [xxx - xxx]

cCl– [xxx - xxx]

<New line>

Metabolite values

cGlu [xxx - xxx]

cLac [xxx - xxx]

ctBil [xxx - xxx]

cUrea/BUN* [xxx - xxx]

cCrea* [xxx - xxx]

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Analysis setup Default setting

Patient report setup <New page>

Temperature-corrected values

pH(T)

pCO2(T)

pO2(T)

<New group>

Oxygen status

ctO2

p50

<New line>

Acid-base status

cBase(Ecf)

cHCO3–(P,st)

* Parameters only available on analyzers configured to feature creatinine and

urea/BUN.

Parameters - default settings

The user-defined settings for Enabled and Locked are saved as the default settings.
No parameter is repressed by default.

Measured Units Offset Slope Out-of-range suppression

parameters

pH N/A 0.000 1.00 N/A

pCO2 mmHg 0.0 1.00 N/A

pO2 mmHg 0.0 1.00 N/A

ctHb g/dL N/A 1.00 No

sO2 % 0.0 1.00 No

FO2Hb % N/A N/A No

FCOHb % 0.0 N/A No

FMetHb % 0.0 N/A No

FHHb % N/A N/A No

FHbF % 0 1.00 Yes

cK+ mmol/L 0.0 1.00 N/A

cNa+ mmol/L 0 1.00 N/A

cCa2+ mmol/L 0.00 1.00 N/A

cCl- mmol/L 0 1.00 N/A

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Measured Units Offset Slope Out-of-range suppression

parameters

cGlu mmol/L 0.0 1.00 N/A

cLac mmol/L 0.0 1.00 N/A

cCrea* µmol/L 0 1.00 N/A

cUrea* mmol/L 0.0 1.00 N/A

cBUN* mg/dL N/A N/A N/A

ctBil µmol/L 0 1.00 N/A

* Parameters only available on analyzers configured to feature creatinine and

urea/BUN.

Measurement units - default settings

Items Default setting

Pressure mmHg

ctBil µmol/L

ctHb g/dL

FCOHb %

FHbF %

FHHb %

FMetHb %

FO2Hb %

sO2 %

Gas fractions %

FO2(I) %

Hct %

pO2(a,A) %

FShunt %

RI %

cK+/cNa+/ cCl– mmol/L

cCa2+ mmol/L

cGlu mmol/L

cLac mmol/L

cCrea* µmol/L

cUrea* mmol/L

cBUN* mg/dL

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Items Default setting

Temperature °C

ctO2 Vol %

ctCO2 Vol %

ḊO2 mL/min

V̇O2 mL/min

Age years

Weight kg

Height m

Altitude m

Birth weight g

* Parameters only available on analyzers configured to feature creatinine and

urea/BUN.

Calibration schedule - default settings

Calibration schedule setup Default setting

tHb calibration Interval: 3 months

First calibration starts at: 00:00

Link QC schedule with calibration schedule: Yes

Quality control setups - default settings

Setups Item Default setting

QC statistics Statistical factor used for value acceptance: 1.5

Automatically print QC statistics when lot changes: Yes

QC input setup Mandatory temperature: No

Default temperature: 25 °C

QC schedule Built-in QC solutions (S9030, S9040, S9050) or (S9230, 04:00, 12:00, 20:00
S9240, S9250) depending on the configuration of the (daily)
analyzer

Run built-in QCs after replacement and startup Yes

Westgard rules Use Westgard Evaluation: No

RiLiBÄK rules Use RiLiBÄK rules No

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Replacement setups - default settings

Menu Item Default setting - interval

Replacement schedule setup Inlet Gasket 12 months

Inlet Probe Never

Connection gasket 12 months

Clean inlet Never

Operator activity schedule None –

Maintenance planning setup None –

Replacement warning setup Number of activities before 5

replacement warning:

Time before replacement 4 hours

warning:

Expected measurements per 10

day:

NOTE: – = There is no default setting.

Communication setup - default settings

Item Default settings

AQURE/RADIANCE connection Not enabled

LIS/HIS connection -

Automatic data request -

Automatic data transmission -

Patient lookup setup On the D:\ drive of the analyzer (local database)

Internal remote support Enable internal remote access: Yes

External remote support Enable external remote access: No

NOTE: - = There is no default setting.

User-defined patient data items - default settings

NOTE: All items have numerical values.

Item Unit Number of decimals

Spontaneous RR b/min 1

Set RR b/min 2

Vt L 2

Ve L 2

Peak flow L/min 1

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Item Unit Number of decimals

Liter flow L/min 2

Ti seconds 1

PEEP cmH2O 1

Pressure support cmH2O 1

CPAP cmH2O 1

CMV Rate 1

SIMV Rate 1

Flow-by L/min 1

HFV Rate 1

I:E ratio – 2

Wave – –

ICD9 code – –

Oxygen device 1 – –

Oxygen device 2 – –

Diagnostic code – –

NOTE: – = There is no default setting.

Corrective actions – default settings

Event Default setting Traffic light color

Calibration error(s) present Do not run scheduled built-in Yellow

QC

Calibration schedule – Yellow

reminder(s)

QC error(s) present ? on specific parameters Yellow

QC schedule reminder(s) – Yellow

Replacement schedule – Yellow

reminder(s)

System message(s) present – Yellow

Operator activity reminder(s) – Yellow

Built-in QC error(s) present – Yellow

NOTE: – = There is no default setting.

Miscellaneous setup - default settings

Item Default setting

Analyzer locked Not enabled

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Item Default setting

Enable estimated derived parameters Not enabled

Fixed pO2/pCO2 decimals Not enabled

Enable general barcode support Enabled

Enable patient result approval Not enabled

Apply parameter corrections to QC Enabled

Log all measurement activities Not enabled

Auto temp unit conversion Not enabled

Enable screen saver Enabled

Show parameter bar Enabled

HbF correction Enabled for levels > 20 %

Analyzer message –

Enable screen saver (the time period the 5 minutes

analyzer must not be in use before the screen
saver is shown)

Printer setup - default settings

Item Default setting

Installed printers The analyzer printer

Manual printing (to see and select a printer Off

from a list of the installed printers)

Automatic printing - default settings

Item Default settings

Patient results On

QC results Off

Calibration results Off

Activity log messages Off

Message level User

Number of copies (to print) 1

Automatic archiving - default settings

Item Default setting

Patient results log On

Calibration log On

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Item Default setting

Quality control log On

Activity log On

Store archives on the analyzer On

Automatic backup - default setting

Item Default setting

Automatic backup Off

Setups with no default settings

• User-defined notes
• Barometer setup
• Time and date setup
• Analyzer identification setup

References

1. Tietz, NW, Logan NM. Reference ranges, In: Tietz NW, ed. Fundamentals of clinical
chemistry: 3rd ed. Philadelphia: WB Saunders Company, 1987: 944-75.
2. Westgard JO, Barry PLL. Cost effective quality control: managing the quality and
productivity of analytical processes. Washington: AACC Press, 1992.

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Performance characteristics 10
Measured parameters – definitions

Measured parameters are parameters measured by the analyzer. Parameter definitions

are shown in the table.

Measured Definition
parameters

pH Is a measure of the acidity or alkalinity of a sample

cH+ Concentration of hydrogen ions in blood

pCO2 Partial pressure (or tension) of carbon dioxide in blood

pO2 Partial pressure (or tension) of oxygen in blood

ctHb Concentration of total hemoglobin in blood

sO2 Oxygen saturation: the ratio between the concentrations of oxyhemoglobin

(cO2Hb) and the hemoglobin (ctHb) minus the dyshemoglobins (cCOHb +
cMetHb)

cO2Hb
=
ceHb

ceHb = cHHb + cO2Hb (effective hemoglobin)

FO2Hb Fraction of oxyhemoglobin in total hemoglobin in blood

FCOHb Fraction of carboxyhemoglobin in total hemoglobin in blood

FMetHb Fraction of methemoglobin in total hemoglobin in blood

FHHb Fraction of deoxyhemoglobin in total hemoglobin in blood

FHbF Fraction of fetal hemoglobin in total hemoglobin in blood

cK+ Concentration of potassium ions in plasma

cNa+ Concentration of sodium ions in plasma

cCa2+ Concentration of calcium ions in plasma

cCl – Concentration of chloride ions in plasma

cGlu Concentration of D-glucose in plasma

cLac Concentration of L-lactate in plasma

ctBil Concentration of total bilirubin in plasma

cCrea* Concentration of creatinine in blood

cUrea* Concentration of urea in blood

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characteristics

Measured Definition
parameters

cBUN* Concentration of urea nitrogen in blood

* Parameters only available on analyzers configured to feature creatinine and

urea/BUN.

About performance characteristics

Overview of performance characteristics

The performance characteristics for parameters measured on the analyzer are based
on the results of performance tests [1]. A comparison is made between the ABL90
FLEX PLUS analyzer and the ABL90 FLEX analyzer.

The 65 µL performance characteristics for the ABL90 FLEX PLUS analyzer are identical
to the performance characteristics of the ABL90 FLEX analyzer in standard mode.

The performance characteristics shown in the table below were calculated from the
results.

Performance charac- Definitions

teristics

BiasPrim.ref The mean difference between results obtained on the ABL90

FLEX/ABL90 FLEX PLUS analyzers and those obtained with primary
reference methods

BiasSec.ref The mean difference between results obtained on the ABL90

FLEX/ABL90 FLEX PLUS analyzers and the ABL735 analyzer

S0 Repeatability (precision estimate)

Sx Reproducibility (precision estimate)

CV % Coefficient of variation

TEA Total analytical error

Uncertainty in performance characteristics

Performance characteristics of the analyzer are calculated from the results of perform-
ance tests. The results are subject to an uncertainty due to test conditions during the
performance tests. Uncertainty values as well as exact values are therefore given for
bias, S0, SX and TEA characteristics.

Performance Assumptions made in the calculation of uncertainty

characteristics

Bias Bias values are described by a normal distribution.

S0 S02 and Sx2, calculated from S0 and Sx values, is described by a

Chi-square distribution
Sx

TEA TEA is calculated from the bias and Sx

The given uncertainty values are calculated at a confidence interval of 68 %.

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An uncertainty at a 68 % confidence interval, which corresponds to 1 SD, can be

converted into an uncertainty at other confidence intervals.

For bias, the uncertainty value at a 68 % confidence interval is given as a plus-minus

value (for example ±x.xxx). For S0 , SX and TEA the upper limit of the uncertainty
values at a 68 % confidence interval are given as plus values (for example +x.xxx).
Related information
To convert an uncertainty at a 68 % confidence level, page 217

To convert an uncertainty at a 68 % confidence level

The table shows the factor you need to multiply uncertainties at a 68 % confidence
level with to convert them to uncertainties at a new confidence level.

New confidence level Multiplication factor

90 % 1.64

95 % 1.96

97.5 % 2.24

99 % 2.58

99.5 % 2.81

99.9 % 3.29

Example:

Uncertaintyat a 95 % confidence interval = Uncertaintyat a 68 % confidence interval × 1.96

Bias

The bias of a quantity is defined as the mean difference between the measured value
on a group of test instruments and the estimated true value (as assayed by the refer-
ence method or certified standard reference material). Bias was determined as follows:

Bias Definition

BiasPrim.ref ̄ BL90 FLEX - xP̄ rimary reference method/material

xA

BiasSec.ref x̄̄ABL90 FLEX - xA

̄ BL735

BiasAuto x̄ABL90 FLEX PLUS (Macromode) - x̄ABL90 FLEX = 0

BiasMicro x̄ABL90 FLEX PLUS (Micromode) - x̄ABL90 FLEX PLUS (Macromode)

BiasSec.ref is a relative bias between the ABL90 FLEX analyzer and the ABL735 analyzer
in macromode (C 195µL mode).

Bias values given in the performance test results were calculated from the performance
test results. The uncertainty given with bias test results was calculated at a 68 %
confidence level.
NOTE: The assumption was made that bias values are normally distributed.

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BiasPrim.ref.

ABL90 FLEX ABL90 FLEX

Prim.Ref. Sec.Ref. (ABL735) ABL90 FLEX
PLUS PLUS
65 μL
65 μL 45 μL

BiasPrim.ref. BiasSec.ref. BiasAuto BiasMicro

ABL90
Prim.Ref. FLEX PLUS
cCrea and
cUrea/BUN
BiasPrim.Ref. 65 µL

Repeatability and reproducibility

Repeated measurements on one analyzer of samples that are assumed to be identical

will not necessarily give identical results. The degree of variation in the results is a
measure of the imprecision (under repeatability conditions) of the analyzer [2].

S0 and Sx values given in the performance test results were calculated from perform-
ance test results. The uncertainty given with bias test results was calculated at a 68 %
confidence level.

NOTE: The assumption was made that S02 and Sx2, calculated from S0 and Sx values,
is described by a Chi-square distribution.

Performance Abbrevi- Description

characteristic ation

Repeatability S0 This is the standard deviation obtained from repeated measure-

ments within a short interval of time with:
• The same instrument and location
• The same measurement procedure
• Identical portions of the same sample
• One operator per analyzer

S0 for each level is pooled for all test analyzers and test days.

The repeatability is equal to S0.

Reproducibility Sx This is the standard deviation obtained from repeated measure-

ments over several days with:
• Random analyzer
• Random sample
• Random operators

The reproducibility for each level is calculated on the basis of all

test analyzers and test days.

The reproducibility is equal to Sx.

Coefficient of variation (CV %)

The coefficient of variation is reported as a percentage and calculated from the mean
(or measuring level) and standard deviation as follows:

S tan dard deviation

CV% = ´ 100
Measuring level

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Confidence intervals

Confidence interval provides a range of values estimated from a study group that is
highly likely to include the true, but unknown, value. A confidence interval applies to
the results of a statistical analysis. A 95 % confidence interval means that there is only
a 5 % chance that the true value is not included in the interval.

Uncertainty values were calculated at a confidence level of 68 % for the bias, S0, SX
and TEA values given in the performance test results.

To calculate the uncertainty values at a confidence level of 95 %, multiply the uncer-

tainty values at a confidence level of 68 % by the factor 1.96.

At a pH level of 6.800, the uncertainty in the bias value at a 68 % confidence level =

±0.0050.

At a pH level of 6.800, the uncertainty in the bias value at a 95 % confidence level =

±0.0050 × 1.96 = ±0.0098.

Total analytical error

TEA , total analytical error is a quality specification that sets a limit for both the random
error (reproducibility) and systematic error (bias) in a single measurement or single
test result.

Total analytical error values given in the performance test results were calculated as
absolute numbers and percentages.
• The equation: TEA = (|Bias|+1.96×Sx), was used to calculate the absolute values
• The equation: TEA = (|Bias %|+1.96×CVx) %, was used to calculate the percentage
values

The uncertainty given with the TEA values is calculated from the uncertainty of the bias
and Sx values at a 68 % confidence level.

The equation used to calculate TEA defines a 95 % confidence interval (0 ±TEA) for the
total analytical error, when the TEA value is corrected with 2 times the uncertainty
given with the TEA value.

About performance tests

Test conditions

Test conditions to determine the performance characteristics for the measured parame-
ters were as follows:

Item Description

Reference analyzers For SC90 parameters:

Five ABL735 analyzers with AutoCheck module were used as a reference.

The capillary mode was used for pCO2 and pO2, and the syringe mode for
all the other parameters.

For SC90 Ki pCO2, Glu and Lac parameters:

5-10 ABL90 FLEX analyzers were used as reference. Capillary mode used
for pCO2. Syringe mode used for Glu and Lac.

For SC90 Ki cCrea and cUrea/BUN parameters:

No reference analyzer used. Primary reference measurements used

directly.

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Item Description

Primary/secondary As specified for each parameter in this chapter

reference methods

Analyzers and test For SC90 parameters:

modes
8-10 ABL90 FLEX analyzers were tested in 65 µL syringe and capillary
modes.

8-10 ABL90 FLEX PLUS analyzers were tested in 45 µL capillary mode.

For SC90 Ki pCO2, Glu, Lac, cCrea and cUrea/BUN parameters:

10-20 ABL90 FLEX PLUS analyzers were tested in 65 uL syringe and

capillary modes.

Blood samples Heparinized blood samples from healthy, voluntary donors. The blood
was prepared to obtain different concentration levels of each measured
parameter.

Blood measurements Measurements on every parameter were done on all analyzers, with 3-5
measurements on every sample of each run, repeated for 3-4 days. The
measurements were done by different operators.

Solution Pack All calibration solutions and gases used for the tests are traceable to
Primary Reference Standards. Contact your local Radiometer representa-
tive for traceability certificates for the ABL90 FLEX PLUS calibration solu-
tions and gases.

Experimental condi- Ambient temperature: 22-25 °C. Relative humidity: 30-50 %. Barometric
tions pressure: 730-780 mmHg.

NOTE: The solutions used in performance tests are those recommended by Radio-
meter. Performances using other solutions cannot be guaranteed. The performance
tests are done under conditions where the analyzers are not influenced by electromag-
netic fields.

Reference methods/materials

Parameter Primary reference method/material Secondary Reference

reference
method

pH Capillary-type glass pH electrode with a saturated ABL735 [3,4]

calomel reference electrode and a liquid junction satu- analyzer
rated with KCl (BMS Mk2).

The calibration standards are traceable to the Primary

Reference Standards for pH.

pCO2 Tonometry. N/A [5]

The gases used for tonometry are traceable to

NIST-certified Standard Reference Materials.

pO2 Tonometry. N/A [5]

The gases used for tonometry are traceable to

NIST-certified Standard Reference Materials.

cCa2+ Calcium transfer standards were used; they have an ABL735 The stand-
ionic strength of 160.0 mmol per kg of water using analyzer ards were
NaCl and a pH of 7.40 at 37 °C, using 1 mmol/L (37 produced
°C) HEPES buffer. These standards are traceable to as indicated
NIST SRM 915 and SRM 956c. in [6]

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Parameter Primary reference method/material Secondary Reference

reference
method

cCl– NIST-certified Standard Reference Material SRM 956c. ABL735

analyzer

cK+ NIST-certified Standard Reference Material SRM 956c. ABL735

analyzer

cNa+ NIST-certified Standard Reference Material SRM 909b ABL735

human serum), NIST 956b and Radiometer-specified analyzer
standard serum material (specified using flame photo-
metry)

cGlu Spectrophotometry which uses the hexokinase (HK) N/A [7]

method recommended by CLSI (formerly NCCLS),
measured on serum

cLac Spectrophotometry which uses a lactate dehydro- N/A [8]

genase (LDH) method, measured on serum

cCrea The reference method is based on Reversed Phase N/A [32]

HPLC. The method is traceable to NIST 914a (Creati-
nine). The method is validated using NIST SRM 967a
(Human Serum).

cUrea/BUN The reference method is a spectrophotometric N/A [33]

method, based on enzymatic reaction. The reference
method is traceable to NIST SRM 912a Urea. The
method is validated using NIST SRM 909c (Human
Serum).

ctBil The reference method for total bilirubin is a spectro- ABL735

photometric method (wet chemistry based on a analyzer
method from Bayer Healthcare, Tarrytown USA).

The method is traceable to NIST SRM916a Bilirubin.

ctHb HiCN method recommended by CLSI (formerly ABL735 [9]

NCCLS) analyzer

sO2 Tonometry: ABL735

analyzer
100%: blood is tonometered with a gas mixture which
contains 94.4% O2 and 5.6% CO2. 0%: blood is tono-
metered with a gas mixture which contains 94.4% N2
and 5.6% CO2 + dithionite.

FO2Hb Measured in accordance with the following relation: ABL735

FO2Hb = 1 - (FHHb + FCOHb + FMetHb) analyzer

FHHb 0%: blood is tonometered with a gas mixture which ABL735

contains 94.4 % N2 and 5.6 % CO2 + dithionite analyzer

FCOHb Gas chromatography: The Standards are carbon ABL735

monoxide mixtures with atmospheric air, whose purity analyzer
is validated in accordance with NIST SRM 1678c (50
ppm CO in N2)

FMetHb Spectrometry, modified Evelyn-Malloy method ABL735 [10]

analyzer

FHbF The reference method is based on Cation Exchange ABL735 [11]

HPLC analyzer

General reference: [25].

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Performance test results

Rounding rules

Normal rounding rules are used to round off all the values given in the performance
test results tables.

pH performance test results

BiasPrim‧ref for pH

pH BiasPrim‧ref N (number of samples analyzed)

7.0 0.005 45

7.4 0.003 45

7.6 0.002 45

BiasPrim.ref = BiasSec.ref + BiasABL735-Prim.ref

65 µL: Performance characteristics for pH – blood samples

pH Value and BiasSec.ref S0 Sx TEA

uncertainty

6.800 Value +0.0200 0.0023 0.0074 0.0345

Uncertainty ±0.0047 +0.0001 +0.0006 +0.0058

7.000 Value –0.0040 0.0015 0.0059 0.0156

Uncertainty ±0.0046 +0.0001 +0.0002 +0.0049

7.200 Value –0.0010 0.0014 0.0074 0.0155

Uncertainty ±0.0046 +0.0001 +0.0007 +0.0059

7.400 Value –0.0020 0.0012 0.0080 0.0178

Uncertainty ±0.0046 +0.0001 +0.0006 +0.0058

7.800 Value –0.0040 0.0009 0.0109 0.0254

Uncertainty ±0.0065 +0.0001 +0.0003 +0.0072

45 µL: Performance characteristics for pH – blood samples

pH Value and BiasSec.ref S0 Sx TEA

uncertainty (Micro)

6.800 Value 0.0132 0.0018 0.0084 0.0297

Uncertainty ±0.0046 +0.0001 +0.0008 +0.0062

7.400 Value 0.0030 0.0020 0.0080 0.0187

Uncertainty ±0.0046 +0.0001 +0.0006 +0.0057

7.800 Value 0.0010 0.0020 0.0110 0.0226

Uncertainty ±0.0065 +0.0001 +0.0002 +0.0070

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BiasSec.ref(Micro) = BiasSec.ref(Macro) + BiasMicro

65 µL: Performance characteristics for pH – blood samples on analyzers configured to

feature creatinine and urea/BUN

pH Value and BiasSec.ref S0 Sx TEA

uncertainty

6.800 Value –0.0040 0.0019 0.0068 0.0173

Uncertainty ±0.0047 +0.0001 +0.0004 +0.0066

7.000 Value –0.0040 0.0015 0.0059 0.0156

Uncertainty ±0.0046 +0.0001 +0.0002 +0.0049

7.200 Value –0.0010 0.0014 0.0074 0.0155

Uncertainty ±0.0046 +0.0001 +0.0007 +0.0059

7.400 Value –0.0020 0.0012 0.0080 0.0178

Uncertainty ±0.0046 +0.0001 +0.0006 +0.0058

7.800 Value –0.0040 0.0009 0.0109 0.0254

Uncertainty ±0.0065 +0.0001 +0.0003 +0.0072

pCO2 performance test results

65 µL: Performance characteristics for pCO2 – blood samples on analyzers configured

to feature creatinine and urea/BUN

pCO2 Value and BiasPrim.ref S0 SX CVX % TEA TEA (%)

(mmHg) uncertainty

15.0 Value –0.29 0.14 0.51 3.4 1.29 8.6

Uncertainty ±0.10 +0.01 +0.03 - +0.16 -

40.0 Value 0.29 0.25 0.52 1.3 1.32 3.3

Uncertainty ±0.09 +0.02 +0.01 - +0.12 -

60.0 Value 0.32 0.44 0.77 1.3 1.83 3.0

Uncertainty ±0.14 +0.03 +0.02 - +0.18 -

80.0 Value –0.41 0.85 1.50 1.9 3.34 4.2

Uncertainty ±0.20 +0.05 +0.08 - +0.36 -

100 Value –0.9 0.70 1.92 1.9 4.67 4.7

Uncertainty ±0.3 +0.04 +0.11 - +0.48 -

65 µL: Performance characteristics for pCO2 – blood samples on analyzers not config-
ured to feature creatinine and urea/BUN

pCO2 Value and BiasPrim.ref S0 SX CVX % TEA TEA (%)

(mmHg) uncertainty

15.0 Value 0.20 0.16 0.71 4.7 1.59 9.9

Uncertainty ±0.14 +0.01 +0.06 - +0.27 -

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65 µL: Performance characteristics for pCO2 – blood samples on analyzers not config-
ured to feature creatinine and urea/BUN

pCO2 Value and BiasPrim.ref S0 SX CVX % TEA TEA (%)

(mmHg) uncertainty

40.0 Value 0.36 0.25 0.57 1.4 1.47 3.7

Uncertainty ±0.14 +0.02 +0.03 - +0.20 -

60.0 Value –0.41 0.29 0.83 1.4 2.05 3.4

Uncertainty ±0.23 +0.02 +0.10 - +0.43 -

80.0 Value –0.34 0.23 1.37 1.7 3.03 3.8

Uncertainty ±0.32 +0.02 +0.18 - +0.68 -

100 Value –0.92 0.90 2.28 2.3 5.39 5.4

Uncertainty ±0.46 +0.06 +0.23 - +0.91 -

45 µL: Performance characteristics for pCO2 – blood samples on analyzers not config-
ured to feature creatinine and urea/BUN

pCO2 Value and BiasPrim.ref S0 Sx CVX % TEA TEA (%)

(mmHg) uncertainty (Micro)

14.0 Value –0.19 0.09 0.52 3.7 1.22 8.7

Uncertainty ±0.20 +0.01 +0.04 - +0.27 -

40.0 Value 0.46 0.19 0.51 1.3 1.46 3.6

Uncertainty ±0.19 +0.01 +0.01 - +0.21 -

100 Value –1.53 0.51 1.86 1.9 5.19 5.2

Uncertainty ±0.65 +0.04 +0.09 - +0.83 -

BiasPrim.ref(Micro) = BiasPrim.ref(Macro) + BiasMicro

- = not applicable

pO2 performance test results

65 µL: Performance characteristics for pO2 – blood samples on analyzers configured to

feature creatinine and urea/BUN

pO2 Value and BiasPrim.ref S0 SX CVX % TEA TEA (%)

(mmHg) uncertainty

15 Value –0.72 0.14 0.54 3.6 1.77 11.8

Uncertainty ±0.18 +0.01 +0.13 - +0.43 -

30.0 Value –0.40 0.13 0.55 1.8 1.47 4.9

Uncertainty ±0.19 +0.01 +0.13 - +0.44 -

75.0 Value –0.59 0.27 0.82 1.1 2.19 2.9

Uncertainty ±0.29 +0.02 +0.11 - +0.52 -

125 Value 0.22 0.62 1.18 0.9 2.54 2.0

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65 µL: Performance characteristics for pO2 – blood samples on analyzers configured to

feature creatinine and urea/BUN

pO2 Value and BiasPrim.ref S0 SX CVX % TEA TEA (%)

(mmHg) uncertainty

125 Uncertainty ±0.42 +0.05 +0.07 - +0.55 -

250 Value –1.35 2.17 3.43 1.4 8.07 3.2

Uncertainty ±0.88 +0.18 +0.39 - +1.66 -

500 Value 5.03 4.11 7.19 1.4 19.13 3.8

Uncertainty ±1.82 +0.34 +0.98 - +3.74 -

65 µL: Performance characteristics for pO2 – blood samples on analyzers not config-
ured to feature creatinine and urea/BUN

pO2 Value and BiasPrim.ref S0 SX CVX % TEA TEA (%)

(mmHg) uncertainty

15 Value –1.14 0.11 0.40 2.7 1.9 12.8

Uncertainty ±0.14 +0.01 +0.06 - +0.3 -

30.0 Value –0.92 0.11 0.56 1.9 2.0 6.7

Uncertainty ±0.15 +0.01 +0.09 - +0.3 -

75.0 Value 0.01 0.19 0.67 0.9 1.3 1.8

Uncertainty ±0.24 +0.01 +0.03 - +0.3 -

125 Value 0.4 0.6 1.3 1.0 2.9 2.3

Uncertainty ±0.4 +0.0 +0.1 - +0.5 -

250 Value 2.0 0.6 2.2 0.9 6.4 2.5

Uncertainty ±0.8 +0.0 +0.1 - +1.0 -

500 Value 6.2 2.6 5.9 1.2 17.8 3.6

Uncertainty ±1.6 +0.2 +0.5 - +2.5 -

45 µL: Performance characteristics for pO2 – blood samples on analyzers not config-
ured to feature creatinine and urea/BUN

pO2 Value and BiasPrim.ref S0 Sx CVX % TEA TEA (%)

(mmHg) uncertainty (Micro)

15 Value 1.51 0.25 0.44 2.9 2.4 15.8

Uncertainty ±0.12 +0.01 +0.02 - +0.2 -

75.0 Value 0.41 0.49 0.82 1.1 2.0 2.7

Uncertainty ±0.22 +0.03 +0.02 - +0.3 -

500 Value 5.4 1.7 4.5 0.9 14.2 2.8

Uncertainty ±1.3 +0.1 +0.2 - +1.6 -

BiasPrim.ref(Micro) = BiasPrim.ref(Macro) + BiasMicro

- = not applicable

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cK+ performance test results

Bias Prim‧ref for cK+

cK+ BiasPrim‧ref N (number of samples analyzed)

(mmol/L)

2.0 0.02 45

4.0 0.00 45

6.0 –0.02 45

BiasPrim.ref = BiasSec.ref + BiasABL735-Prim.ref

65 µL: Performance characteristics for cK+ – blood samples

cK+ Value and BiasSec.ref S0 Sx CVX % TEA TEA(%)

uncertainty (Macro)
(mmol/L)

2.0 Value -0.10 0.04 0.09 4.3 0.27 13.4

Uncertainty ±0.07 +0.00 +0.00 - +0.08 -

4.0 Value -0.01 0.03 0.08 2.0 0.17 4.2

Uncertainty ±0.07 +0.00 +0.00 - +0.07 -

6.0 Value 0.04 0.03 0.10 1.7 0.24 4.0

Uncertainty ±0.08 +0.00 +0.01 - +0.10 -

8.0 Value 0.07 0.03 0.12 1.5 0.30 3.7

Uncertainty ±0.09 +0.00 +0.01 - +0.11 -

10.0 Value 0.10 0.04 0.12 1.2 0.34 3.4

Uncertainty ±0.09 +0.00 +0.01 - +0.11 -

45 µL: Performance characteristics for cK+ – blood samples

cK+ Value and BiasSec.ref S0 Sx CVX % TEA TEA (%)

uncertainty (Micro)
(mmol/L)

2.0 Value –0.06 0.06 0.10 4.9 0.25 12.6

Uncertainty ±0.07 +0.00 +0.00 - +0.07 -

4.0 Value –0.03 0.04 0.09 2.2 0.21 5.1

Uncertainty ±0.07 +0.00 +0.00 - +0.07 -

10.0 Value –0.08 0.09 0.15 1.5 0.37 3.7

Uncertainty ±0.09 +0.01 +0.00 - +0.10 -

BiasSec.ref(Micro) = BiasSec.ref(Macro) + BiasMicro

- = not applicable

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cNa+ performance test results

65 µL: Performance characteristics for cNa+ – blood samples

cNa+ Value and BiasPrim.ref* S0 Sx CVX % TEA TEA(%)

(mmol/L) uncertainty

100 Value 0.7 0.3 1.1 1.1 2.8 2.8

Uncertainty ±0.7 +0.0 +0.2 - +1.0 -

120 Value 0.5 0.3 1.0 0.8 2.4 2.0

Uncertainty ±0.8 +0.0 +0.1 - +0.9 -

130 Value 0.8 0.3 1.0 0.8 2.9 2.2

Uncertainty ±0.8 +0.0 +0.1 - +1.0 -

140 Value 0.6 0.3 1.1 0.8 2.7 1.9

Uncertainty ±0.8 +0.0 +0.1 - +1.0 -

160 Value 1.0 0.4 1.1 0.7 3.2 2.0

Uncertainty ±0.9 +0.0 +0.0 - +1.0 -

180 Value 0.7 0.4 1.4 0.8 3.4 1.9

Uncertainty ±1.0 +0.0 +0.1 - +1.2 -

* The ABL735 measurements are corrected to the primary reference method through
this equation: NaABL735, corrected = 1.055 × NaABL735, measured – 6.8966 (mmol/L)

45 µL: Performance characteristics for cNa+ – blood samples

cNa+ Value and BiasPrim.ref(Micro) S0 Sx CVX % TEA TEA (%)

(mmol/L) uncertainty

100 Value –0.5 0.4 1.0 1.0 2.3 2.3

Uncertainty ±0.7 +0.0 +0.1 - +0.8 -

140 Value 0.3 0.4 1.2 0.8 2.6 1.8

Uncertainty ±0.8 +0.0 +0.1 - +1.0 -

180 Value 1.1 0.4 1.3 0.7 3.7 2.1

Uncertainty ±1.0 +0.0 +0.1 - +1.1 -

BiasPrim.ref(Micro) = BiasPrim.ref(Macro) + BiasMicro

- = not applicable

cCl– performance test results

BiasPrim.ref for cCl–

cCl– BiasPrim.ref N (number of samples analyzed)

(mmol/L)

104.9 2.4 45

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BiasPrim.ref for cCl–

cCl– BiasPrim.ref N (number of samples analyzed)

(mmol/L)

121.5 1.7 45

137.5 3.5 45

BiasPrim.ref = BiasSec.ref + BiasABL735-Prim.ref

65 µL: Performance characteristics for cCl– – blood samples

cCl– Value and BiasSec.ref(Macro) S0 Sx CVX % TEA TEA(%)

uncertainty
(mmol/L)

80 Value –1.1 0.3 1.0 1.2 3.1 3.8

Uncertainty ±0.7 +0.0 +0.1 - +0.8 -

100 Value –1.1 0.3 1.2 1.2 3.5 3.4

Uncertainty ±0.8 +0.0 +0.0 - +0.9 -

120 Value –1.4 0.3 1.4 1.2 4.2 3.5

Uncertainty ±0.9 +0.0 +0.0 - +1.0 -

140 Value –1.4 0.3 2.2 1.6 5.7 4.1

Uncertainty ±1.0 +0.0 +0.2 - +1.4 -

150 Value –1.4 0.4 2.1 1.4 5.5 3.7

Uncertainty ±1.1 +0.0 +0.0 - +1.2 -

45 µL: Performance characteristics for cCl– – blood samples

cCl– Value and BiasSec.ref(Micro) S0 Sx CVX % TEA TEA (%)

uncertainty
(mmol/L)

80 Value –0.9 0.3 0.9 1.1 2.7 3.4

Uncertainty ±0.7 +0.0 +0.0 - +0.8 -

100 Value –0.1 0.4 1.3 1.3 2.5 2.5

Uncertainty ±0.8 +0.0 +0.1 - +1.0 -

150 Value –1.2 0.4 2.0 1.3 5.1 3.4

Uncertainty ±1.1 +0.0 +0.0 - +1.1 -

BiasSec.ref(Micro) = BiasSec.ref(Macro) + BiasMicro

- = not applicable

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cCa2+ performance test results

BiasPrim.ref for cCa2+

cCa2+ BiasPrim.ref N (number of samples analyzed)

(mmol/L)

0.49 0.025 45

1.23 0.018 45

2.51 0.009 45

BiasPrim.ref = BiasSec.ref + BiasABL735-Prim.ref

65 µL: Performance characteristics for cCa2+ – blood samples

cCa2+ Value and BiasSec.ref S0 Sx CVX % TEA TEA(%)

uncertainty
(mmol/L)

0.50 Value –0.043 0.004 0.020 4.0 0.083 16.5

Uncertainty ±0.008 +0.000 +0.002 - +0.013 -

0.75 Value –0.018 0.003 0.018 2.4 0.053 7.1

Uncertainty ±0.008 +0.000 +0.002 - +0.011 -

1.25 Value 0.005 0.004 0.016 1.3 0.037 3.0

Uncertainty ±0.008 +0.000 +0.000 - +0.008 -

1.75 Value 0.034 0.007 0.028 1.6 0.088 5.0

Uncertainty ±0.016 +0.000 +0.001 - +0.019 -

2.50 Value 0.057 0.008 0.053 2.1 0.160 6.4

Uncertainty ±0.035 +0.001 +0.003 - +0.041 -

45 µL: Performance characteristics for cCa2+ – blood samples

cCa2+ Value and BiasSec.ref S0 Sx CVX % TEA TEA (%)

uncertainty (Micro)
(mmol/L)

0.5 Value –0.043 0.005 0.022 4.4 0.086 17.2

Uncertainty ±0.08 +0.000 +0.003 - +0.014 -

1.25 Value 0.006 0.006 0.017 1.4 0.040 3.2

Uncertainty ±0.08 +0.000 +0.000 - +0.009 -

2.50 Value 0.064 0.013 0.059 2.4 0.179 7.2

Uncertainty ±0.035 +0.001 +0.005 - +0.044 -

BiasSec.ref(Micro) = BiasSec.ref(Macro) + BiasMicro

* Trisodium citrate added to whole blood sample

- = not applicable

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characteristics

cGlu performance test results

65 µL: Performance characteristics for cGlu in blood with a pO2 ≥90 mmHg on
analyzers configured to feature creatinine and urea/BUN

cGlu Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

0.3 Value –0.02 0.03 0.08 25.5 0.17 56.7

Uncer- ±0.03 +0.00 +0.01 - +0.05 -

tainty

2.0 Value –0.05 0.03 0.10 4.8 0.24 11.8

Uncer- ±0.04 +0.00 +0.01 - +0.06 -

tainty

6.0 Value 0.07 0.04 0.20 3.4 0.47 7.9

Uncer- ±0.05 +0.00 +0.04 - +0.13 -

tainty

10.0 Value 0.23 0.05 0.42 4.2 1.05 10.5

Uncer- ±0.09 +0.01 +0.11 - +0.31 -

tainty

15.0 Value 0.35 0.16 0.55 3.6 1.41 9.4

Uncer- ±0.15 +0.01 +0.11 - +1.46

tainty

25 Value 1.0 0.4 0.9 3.8 2.8 11.3

Uncer- ±0.2 +0.0 +0.2 - +0.7 -

tainty

40 Value 0.6 0.6 1.7 4.2 3.8 9.6

Uncer- ±0.5 +0.1 +0.4 - +1.2 -

tainty

65 µL: Performance characteristics for cGlu in blood with a pO2 ≥90 mmHg on
analyzers not configured to feature creatinine and urea/BUN

cGlu Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

0.3 Value 0.00 0.03 0.09 29.3 0.17 57.5

Uncer- ±0.04 +0.00 +0.01 - +0.05 -

tainty

2.0 Value –0.01 0.04 0.10 4.8 0.20 9.9

Uncer- ±0.04 +0.00 +0.01 - +0.06 -

tainty

6.0 Value 0.24 0.07 0.16 2.7 0.56 9.3

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65 µL: Performance characteristics for cGlu in blood with a pO2 ≥90 mmHg on
analyzers not configured to feature creatinine and urea/BUN

cGlu Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

6.0 Uncer- ±0.04 +0.01 +0.01 - +0.07 -

tainty

10.0 Value 0.16 0.09 0.24 2.4 0.62 6.2

Uncer- ±0.04 +0.01 +0.03 - +0.10 -

tainty

25 Value 1.2 0.3 0.9 3.5 2.9 11.6

Uncer- ±0.2 +0.0 +0.1 - +0.4 -

tainty

40 Value 1.5 0.6 2.3 5.9 6.1 15.1

Uncer- ±0.4 +0.0 +0.5 - +1.4 -

tainty

45 µL: Performance characteristics for cGlu in blood with a pO2 ≥90 mmHg on
analyzers not configured to feature creatinine and urea/BUN

cGlu Value BiasPrim.ref(Micro) S0 Sx CVX TEA TEA

(mmol/L) and % (%)
uncer-
tainty

0.3 Value 0.00 0.04 0.09 28.8 0.17 56.4

Uncer- ±0.05 +0.00 +0.01 - +0.06 -

tainty

6.0 Value 0.24 0.13 0.22 3.6 0.66 11.1

Uncer- ±0.06 +0.01 +0.01 - +0.08 -

tainty

10.0 Value 0.32 0.25 0.38 3.8 1.06 10.6

Uncer- ±0.05 +0.02 +0.03 - +0.11 -

tainty

40 Value 1.5 0.9 2.3 5.7 5.9 14.7

Uncer- ±0.6 +0.1 +0.3 - +1.2 -

tainty

BiasPrim.ref(Micro) = BiasPrim.ref(Macro) + BiasMicro

- = not applicable

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characteristics

65 µL: Performance characteristics for cGlu in blood with 25 mmHg ≤ pO2 <90 mmHg
on analyzers configured to feature creatinine and urea/BUN

cGlu Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

0.3 Value –0.02 0.03 0.08 25.5 0.17 56.7

Uncer- ±0.03 +0.00 +0.01 - +0.05 -

tainty

2.0 Value –0.05 0.03 0.10 4.8 0.24 11.8

Uncer- ±0.04 +0.00 +0.01 - +0.06 -

tainty

6.0 Value 0.07 0.05 0.22 3.7 0.50 8.4

Uncer- ±0.06 +0.00 +0.06 - +0.17 -

tainty

10.0 Value 0.23 0.05 0.42 4.2 1.05 10.5

Uncer- ±0.09 +0.01 +0.11 - +0.31 -

tainty

15.0 Value –0.50 0.11 0.57 3.8 1.62 10.8

Uncer- ±0.16 +0.01 +0.14 - +0.68

tainty

25 Value –0.1 0.4 0.8 3.0 1.6 6.4

Uncer- ±0.1 +0.0 +0.1 - +0.3 -

tainty

40 Value –2.4 0.5 1.3 3.3 4.9 12.3

Uncer- ±0.3 +0.1 +0.2 - +0.7 -

tainty

65 µL: Performance characteristics for cGlu in blood with 25 mmHg ≤ pO2 <90 mmHg
on analyzers not configured to feature creatinine and urea/BUN

cGlu Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

0.3 Value 0.00 0.03 0.11 37.4 0.22 73.3

Uncer- ±0.03 +0.00 +0.02 - +0.08 -

tainty

2.0 Value –0.01 0.03 0.10 5.0 0.20 10.2

Uncer- ±0.04 +0.00 +0.02 - +0.07 -

tainty

6.0 Value 0.24 0.05 0.22 3.7 0.67 11.2

Uncer- ±0.07 +0.00 +0.06 - +0.18 -

tainty

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65 µL: Performance characteristics for cGlu in blood with 25 mmHg ≤ pO2 <90 mmHg
on analyzers not configured to feature creatinine and urea/BUN

cGlu Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

10.0 Value 0.16 0.10 0.41 4.1 0.96 9.6

Uncer- ±0.11 +0.01 +0.11 - +0.33 -

tainty

25 Value 0.3 0.4 1.4 5.6 3.0 12.0

Uncer- ±0.4 +0.0 +0.4 - +1.2 -

tainty

40 Value –0.1 0.8 3.2 7.9 6.3 15.8

Uncer- ±0.7 +0.1 +0.9 - +2.5 -

tainty

45 µL: Performance characteristics for cGlu in blood with 25 mmHg ≤ pO2 <90 mmHg
on analyzers not configured to feature creatinine and urea/BUN

cGlu Value BiasPrim.ref(Micro) S0 Sx CVX TEA TEA

(mmol/L) and % (%)
uncer-
tainty

0.3 Value 0.00 0.04 0.09 28.8 0.17 56.4

Uncer- ±0.05 +0.00 +0.01 - +0.06 -

tainty

6.0 Value 0.24 0.13 0.22 3.6 0.66 11.1

Uncer- ±0.06 +0.01 +0.01 - +0.08 -

tainty

25 Value 0.3 0.4 1.2 4.7 2.5 10.2

Uncer- ±0.5 +0.0 +0.2 - 0.9 -

tainty

40 Value –0.1 0.8 2.7 6.8 5.5 13.7

Uncer- ±1.0 +0.1 +0.6 - +2.1 -

tainty

BiasPrim.ref(Micro) = BiasPrim.ref(Macro) + BiasMicro

- = not applicable

65 µL: Performance characteristics for cGlu in blood with 10 mmHg < pO2 <25 mmHg
on analyzers configured to feature creatinine and urea/BUN

cGlu Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

0.3 Value –0.02 0.03 0.08 25.5 0.17 56.7

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65 µL: Performance characteristics for cGlu in blood with 10 mmHg < pO2 <25 mmHg
on analyzers configured to feature creatinine and urea/BUN

cGlu Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

0.3 Uncer- ±0.03 +0.00 +0.01 - +0.05 -

tainty

2.0 Value –0.05 0.03 0.10 4.8 0.24 11.8

Uncer- ±0.04 +0.00 +0.01 - +0.06 -

tainty

6.0 Value 0.07 0.05 0.22 3.7 0.50 8.4

Uncer- ±0.06 +0.00 +0.06 - +0.17 -

tainty

10.0 Value –0.13 0.10 0.58 5.8 1.27 12.7

Uncer- ±0.15 +0.01 +0.18 - +0.49 -

tainty

15.0 Value –0.50 0.11 0.57 3.8 1.62 10.8

Uncer- ±0.16 +0.01 +0.14 - +1.72 -

tainty

25 Value 0.4 0.4 1.1 4.2 2.5 9.9

Uncer- ±0.3 +0.0 +0.3 - +0.8 -

tainty

65 µL: Performance characteristics for cGlu in blood with 10 mmHg < pO2 <25 mmHg
on analyzers not configured to feature creatinine and urea/BUN

cGlu Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

0.3 Value 0.00 0.03 0.07 24.2 0.14 47.4

Uncer- ±0.03 +0.00 +0.00 - +0.04 -

tainty

2.0 Value –0.01 0.03 0.10 4.9 0.20 10.1

Uncer- ±0.04 +0.00 +0.01 - +0.07 -

tainty

6.0 Value 0.24 0.05 0.28 4.7 0.79 13.2

Uncer- ±0.08 +0.00 +0.08 - +0.24 -

tainty

10.0 Value 0.16 0.08 0.63 6.3 1.39 13.9

Uncer- ±0.15 +0.01 +0.18 - +0.50 -

tainty

25 Value –0.8 0.36 2.2 9.0 5.2 20.9

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65 µL: Performance characteristics for cGlu in blood with 10 mmHg < pO2 <25 mmHg
on analyzers not configured to feature creatinine and urea/BUN

cGlu Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

25 Uncer- ±0.6 +0.0 +0.6 - +1.8 -

tainty

45 µL: Performance characteristics for cGlu in blood with 10 mmHg < pO2 <25 mmHg
on analyzers not configured to feature creatinine and urea/BUN

cGlu Value BiasPrim.ref(Micro) S0 Sx CVX TEA TEA

(mmol/L) and % (%)
uncer-
tainty

0.3 Value 0.00 0.04 0.09 28.8 0.17 56.4

Uncer- ±0.05 +0.00 +0.01 - 0.06 -

tainty

2.0 Value –0.01 0.05 0.11 5.3 0.22 10.9

Uncer- ±0.05 +0.00 +0.01 - 0.07 -

tainty

6.0 Value 0.24 0.09 0.24 4.0 0.71 11.8

Uncer- ±0.12 +0.01 +0.03 - +0.17 -

tainty

25 Value –0.8 0.4 1.6 6.3 3.9 15.6

Uncer- ±0.8 +0.0 +0.3 - +1.5 -

tainty

BiasPrim.ref(Micro) = BiasPrim.ref(Macro) + BiasMicro

- = not applicable

pO2 levels - how they affect cGlu results

WARNING – Risk of incorrect results

Low pO2 levels can have an effect on the linearity of glucose measurements. This can
lead to incorrect low glucose results. Please note that cGlu linearity is not specified
when the pO2 level is less than 10 mmHg (1.3 kPa).

pO2 levels in a sample cGlu linearity is specified in the range

mmHg kPa

<10 <1.3 Linearity not specified. The cGlu value is not usable.

10 ≤pO2 <25 1.3 ≤pO2 <3.3 0-25 mmol/L.

If cGlu value >25 mmol/L, the linearity is not specified and the
cGlu value not usable.

≥25 ≥3.3 The entire reportable range.

If pO2 <10 mmHg (<1.3 kPa), the cGlu value is not usable and no value is shown.
Analyzer message no. 1387 tells you that the cGlu value is not usable.

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cLac performance test results

65 µL: Performance characteristics for cLac in blood with a pO2 ≥90 mmHg on
analyzers configured to feature creatinine and urea/BUN

cLac Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

0.3 Value -0.05 0.03 0.09 29.0 0.22 73.5

Uncer- ±0.05 +0.00 +0.00 - +0.05 -

tainty

1.0 Value -0.15 0.03 0.09 9.0 0.33 32.6

Uncer- ±0.05 +0.00 +0.00 - +0.05 -

tainty

5.0 Value -0.19 0.04 0.20 3.9 0.57 11.5

Uncer- ±0.06 +0.00 +0.04 - +0.15 -

tainty

10.0 Value 0.13 0.12 0.29 2.9 0.70 7.0

Uncer- ±0.08 +0.01 +0.03 - +0.14 -

tainty

15 Value 0.1 0.3 0.8 5.3 1.6 10.9

Uncer- ±0.2 +0.0 +0.2 - +0.5 -

tainty

25 Value -0.2 0.4 0.7 2.8 1.6 6.3

Uncer- ±0.2 +0.0 +0.0 - +0.3 -

tainty

65 µL: Performance characteristics for cLac in blood with a pO2 ≥90 mmHg on
analyzers not configured to feature creatinine and urea/BUN

cLac Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

0.3 Value –0.04 0.03 0.08 28.1 0.21 68.4

Uncer- ±0.04 +0.00 +0.01 - +0.05 -

tainty

1.0 Value –0.14 0.06 0.13 12.8 0.39 39.1

Uncer- ±0.04 +0.00 +0.02 - +0.08 -

tainty

5.0 Value –0.14 0.07 0.23 4.5 0.58 11.7

Uncer- ±0.04 +0.01 +0.05 - +0.13 -

tainty

10.0 Value 0.20 0.11 0.77 7.7 1.71 17.1

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65 µL: Performance characteristics for cLac in blood with a pO2 ≥90 mmHg on
analyzers not configured to feature creatinine and urea/BUN

cLac Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

10.0 Uncer- ±0.07 +0.01 +0.22 - +0.50 -

tainty

15 Value 0.1 0.3 1.0 6.4 1.9 12.9

Uncer- ±0.2 +0.0 +0.2 - +0.7 -

tainty

25 Value –0.9 0.4 2.3 9.3 5.5 22.0

Uncer- ±0.5 +0.0 +0.7 - +1.9 -

tainty

45 µL: Performance characteristics for cLac in blood with a pO2 ≥90 mmHg on
analyzers not configured to feature creatinine and urea/BUN

cLac Value BiasPrim.ref(Micro) S0 Sx CVX TEA TEA

(mmol/L) and % (%)
uncer-
tainty

1.0 Value –0.14 0.04 0.12 12.0 0.38 37.5

Uncer- ±0.05 +0.00 +0.01 - +0.08 -

tainty

5.0 Value –0.03 0.12 0.28 5.6 0.58 11.6

Uncer- ±0.05 +0.01 +0.05 - +0.14 -

tainty

25 Value –0.9 0.5 2.7 10.8 6.2 24.9

Uncer- ±0.7 +0.0 +0.5 - +1.7 -

tainty

BiasPrim.ref(Micro) = BiasPrim.ref(Macro) + BiasMicro

- = not applicable

65 µL: Performance characteristics for cLac in blood with a pO2 <90 mmHg on
analyzers configured to feature creatinine and urea/BUN

cLac Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

0.3 Value -0.05 0.03 0.09 29.0 0.22 73.5

Uncer- ±0.05 +0.00 +0.00 - +0.05 -

tainty

1.0 Value -0.15 0.03 0.09 9.0 0.33 32.6

Uncer- ±0.05 +0.00 +0.00 - +0.05 -

tainty

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65 µL: Performance characteristics for cLac in blood with a pO2 <90 mmHg on
analyzers configured to feature creatinine and urea/BUN

cLac Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

5.0 Value -0.19 0.04 0.20 3.9 0.57 11.5

Uncer- ±0.06 +0.00 +0.04 - +0.15 -

tainty

10.0 Value –0.28 0.16 0.49 4.9 1.23 12.3

Uncer- ±0.14 +0.02 +0.12 - +0.37 -

tainty

15 Value –0.5 0.3 0.5 3.4 1.5 9.2

Uncer- ±0.2 +0.0 +0.0 - +0.2 -

tainty

25 Value –0.4 0.4 0.7 2.8 1.8 7.1

Uncer- ±0.2 +0.0 +0.0 - +0.3 -

tainty

65 µL: Performance characteristics for cLac in blood with a pO2 <90 mmHg on
analyzers not configured to feature creatinine and urea/BUN

cLac Value BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) and
uncer-
tainty

0.3 Value –0.04 0.03 0.08 28.1 0.21 68.4

Uncer- ±0.04 +0.00 +0.01 - +0.05 -

tainty

1.0 Value –0.14 0.04 0.09 9.4 0.32 32.5

Uncer- ±0.04 +0.00 +0.01 - +0.06 -

tainty

5.0 Value –0.14 0.10 0.33 6.6 0.79 15.8

Uncer- ±0.05 +0.01 +0.08 - +0.20 -

tainty

10.0 Value –0.16 0.08 0.79 7.9 1.70 17.0

Uncer- ±0.13 +0.01 +0.22 - +0.56 -

tainty

15 Value –0.6 0.3 1.2 8.0 3.0 20.0

Uncer- ±0.3 +0.0 +0.3 - +0.9 -

tainty

25 Value –2.4 0.4 2.7 10.9 7.7 30.9

Uncer- ±0.7 +0.0 +0.9 - +2.5 -

tainty

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45 µL: Performance characteristics for cLac in blood with a pO2 <90 mmHg on
analyzers not configured to feature creatinine and urea/BUN

cLac Value BiasPrim.ref(Micro) S0 Sx CVX TEA TEA

(mmol/L) and % (%)
uncer-
tainty

1.0 Value –0.14 0.04 0.12 12.0 0.38 37.5

Uncer- ±0.05 +0.00 +0.01 - +0.08 -

tainty

15 Value –0.64 0.3 1.7 11.2 3.9 26.3

Uncer- ±0.4 +0.0 +0.2 - +0.9 -

tainty

25 Value –2.41 0.4 3.1 12.5 8.5 34.1

Uncer- ±1.0 +0.0 +0.5 - +1.9 -

tainty

BiasPrim.ref(Micro) = BiasPrim.ref(Macro) + BiasMicro

- = not applicable

ctHb performance test results

Setup: Adult blood samples. HbF correction is not enabled.

65 µL: Performance characteristics for ctHb – blood samples

ctHb sO2 (%) Value and BiasPrim.ref* S0 SX CVX % TEA TEA

(g/dL) uncertainty (%)

0.00 Undefined Value –0.020 0.010 0.020 - 0.060 -

Uncertainty ±0.003 +0.001 +0.004 - +0.010 -

3.5 100 Value 0.02 0.05 0.08 2.4 0.19 5.3

Uncertainty ±0.04 +0.00 +0.00 - +0.05 -

7.0 100 Value 0.05 0.09 0.17 2.4 0.37 5.3

Uncertainty ±0.07 +0.01 +0.01 - +0.09 -

10.0 100 Value 0.06 0.08 0.20 2.0 0.45 4.5

Uncertainty ±0.09 +0.01 +0.01 - +0.12 -

15.0 100 Value 0.06 0.08 0.25 1.6 0.54 3.6

Uncertainty ±0.12 +0.01 +0.02 - +0.16 -

20.0 100 Value 0.00 0.09 0.30 1.5 0.58 2.9

Uncertainty ±0.14 +0.01 +0.02 - +0.19 -

25.0 100 Value 0.08 0.11 0.37 1.5 0.80 3.2

Uncertainty ±0.18 +0.01 +0.04 - +0.25 -

* The ABL735 measurements are corrected to the primary reference method through
this equation:

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ABL735 HICNcorrected: ctHbABL735, corrected = -0.000707 × (ctHbABL735, measured)2 +

0.9977 × ctHbABL735, measured (g/dL)

45 µL: Performance characteristics for ctHb – blood samples

ctHb sO2 (%) Value and BiasPrim.ref(Micro) S0 Sx CVX % TEA TEA

(g/dL) uncertainty (%)

3.5 100 Value 0.02 0.04 0.08 2.3 0.18 5.2

Uncertainty ±0.05 +0.00 +0.00 - +0.06 -

15.0 100 Value 0.06 0.08 0.23 1.5 0.50 3.3

Uncertainty ±0.16 +0.01 +0.01 - +0.18 -

20.0 100 Value 0.00 0.09 0.27 1.3 0.53 2.6

Uncertainty ±0.20 +0.01 +0.01 - +0.35 -

25.0 100 Value 0.08 0.11 0.33 1.3 0.73 2.9

Uncertainty ±0.25 +0.01 +0.01 - +0.27 -

BiasPrim.ref(Micro) = BiasPrim.ref(Macro) + BiasMicro

- = not applicable

sO2 performance test results

Setup: Adult blood samples. HbF correction not enabled.

BiasPrim.ref for sO2

sO2 (%) ctHb BiasPrim.ref N (number of

(g/dL) samples analyzed)

0.0 15 0.07 150

100.0 15 0.23 150

100.0 7 0.46 150

100.0 25 0.00 148

BiasPrim.ref = BiasSec.ref + BiasABL735-Prim.ref

65 µL: Performance characteristics for sO2 – blood samples

sO2 (%) ctHb Value and BiasSec.ref S0 SX CVX % TEA TEA

(g/dL) uncertainty (%)

0.0 15 Value 0.09 0.08 0.26 - 0.59 -

Uncertainty ±0.20 +0.01 +0.01 - +0.23 -

50.0 15 Value –0.26 0.24 0.40 0.8 1.05 2.1

Uncertainty ±0.30 +0.02 +0.01 - +0.32 -

65.0 15 Value –0.20 0.27 0.46 0.7 1.11 1.7

Uncertainty ±0.30 +0.02 +0.03 - +0.37 -

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65 µL: Performance characteristics for sO2 – blood samples

sO2 (%) ctHb Value and BiasSec.ref S0 SX CVX % TEA TEA

(g/dL) uncertainty (%)

75.0 15 Value –0.10 0.30 0.48 0.6 1.05 1.4

Uncertainty ±0.30 +0.02 +0.03 - +0.35 -

90.0 15 Value –0.10 0.19 0.36 0.4 0.80 0.9

Uncertainty ±0.21 +0.01 +0.05 - +0.30 -

100.0 15 Value –0.07 0.09 0.29 0.3 0.64 0.6

Uncertainty ±0.17 +0.01 +0.06 - +0.28 -

100.0 7 Value 0.45 0.11 0.37 0.4 1.17 1.2

Uncertainty ±0.16 +0.01 +0.09 - +0.33 -

100.0 25 Value –0.53 0.09 0.28 0.3 1.08 1.1

Uncertainty ±0.16 +0.01 +0.06 - +0.27 -

45 µL: Performance characteristics for sO2 – blood samples

sO2 (%) ctHb Value and BiasSec.ref(Micro) S0 Sx CVX % TEA TEA

(g/dL) uncertainty (%)

0.0 15 Value 0.09 0.05 0.23 - 0.53 -

Uncertainty ±0.28 +0.00 +0.01 - +0.31 -

75.0 15 Value –0.10 0.18 0.41 0.5 0.90 1.2

Uncertainty ±0.43 +0.01 +0.02 - +0.46 -

100.0 15 Value –0.07 0.07 0.29 0.3 0.64 0.6

Uncertainty ±0.24 +0.00 +0.05 - +0.34 -

BiasSec.ref(Micro) = BiasSec.ref(Macro) + BiasMicro

- = not applicable

FO2Hb performance test results

Setup: Adult blood samples. HbF correction is not enabled.

65 µL: Performance characteristics for FO2Hb – blood samples

FO2Hb ctHb (g/dL) Value and BiasSec.ref S0 SX CVX % TEA TEA

(%) uncertainty (%)

0.0 15 Value 0.07 0.08 0.26 - 0.57 -

Uncertainty ±0.20 +0.01 +0.01 - +0.23 -

50.0 15 Value –0.25 0.27 0.58 1.2 1.38 2.8

Uncertainty ±0.31 +0.02 +0.06 - +0.42 -

65.0 15 Value –0.43 0.30 0.48 0.7 1.37 2.1

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65 µL: Performance characteristics for FO2Hb – blood samples

FO2Hb ctHb (g/dL) Value and BiasSec.ref S0 SX CVX % TEA TEA

(%) uncertainty (%)

65.0 15 Uncertainty ±0.32 +0.02 +0.01 - +0.35 -

75.0 15 Value –0.27 0.35 0.55 0.7 1.35 1.8

Uncertainty ±0.33 +0.02 +0.03 - +0.40 -

90.0 15 Value –0.23 0.23 0.40 0.4 1.02 1.1

Uncertainty ±0.27 +0.02 +0.04 - +0.33 -

100.0 15 Value –0.10 0.16 0.38 0.4 0.85 0.9

Uncertainty ±0.24 +0.01 +0.06 - +0.35 -

100.0 7 Value –0.09 0.19 0.48 0.5 1.03 1.0

Uncertainty ±0.25 +0.01 +0.09 - +0.43 -

100.0 25 Value –0.45 0.18 0.53 0.5 1.50 1.5

Uncertainty ±0.26 +0.01 +0.13 - +0.52 -

45 µL: Performance characteristics for FO2Hb – blood samples

FO2Hb ctHb Value and BiasSec.ref(Micro) S0 Sx CVX % TEA TEA

(%) (g/dL) uncertainty (%)

0.0 15 Value 0.07 0.05 0.23 - 0.51 -

Uncertainty ±0.28 +0.00 +0.01 - +0.31 -

75.0 15 Value –0.27 0.21 0.48 0.6 1.22 1.6

Uncertainty ±0.47 +0.02 +0.03 - +0.54 -

100.0 15 Value –0.10 0.15 0.42 0.4 0.92 0.9

Uncertainty ±0.34 +0.01 +0.07 - +0.47 -

BiasSec.ref(Micro) = BiasSec.ref(Macro) + BiasMicro

- = not applicable

FCOHb performance test results

Setup: Adult arterial blood samples. HbF correction is not enabled.

BiasPrim.ref for FCOHb

FCOHb (%) ctHb (g/dL) BiasPrim.ref N (number of samples analyzed)

0.0 15 0.41 45

20.0 15 –0.01 45

BiasPrim.ref = BiasSec.ref + BiasABL735-Prim.ref

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65 µL: Performance characteristics for FCOHb – blood samples

FCOHb (%) ctHb Value and BiasSec.ref S0 SX CVX % TEA TEA

(g/dL) uncertainty (%)

0.0 15 Value 0.00 0.08 0.24 - 0.46 -

Uncertainty ±0.16 +0.01 +0.04 - +0.23 -

5.0 15 Value 0.08 0.08 0.26 5.1 0.58 11.7

Uncertainty ±0.20 +0.01 +0.03 - +0.26 -

10.0 15 Value 0.04 0.07 0.34 3.4 0.71 7.1

Uncertainty ±0.30 +0.00 +0.02 - +0.35 -

20.0 15 Value 0.11 0.08 0.67 3.4 1.43 7.1

Uncertainty ±0.65 +0.01 +0.01 - +0.67 -

30.0 15 Value 0.17 0.08 0.68 2.3 1.50 5.0

Uncertainty ±0.65 +0.01 +0.02 - +0.69 -

50.0 15 Value 0.30 0.09 0.68 1.4 1.63 3.3

Uncertainty ±0.65 +0.01 +0.01 - +0.68 -

99.0 15 Value 0.54 0.12 0.72 0.7 1.96 2.0

Uncertainty ±0.66 +0.01 +0.04 - +0.74 -

45 µL: Performance characteristics for FCOHb – blood samples

FCOHb ctHb Value and BiasSec.ref(Micro) S0 Sx CVX % TEA TEA

(%) (g/dL) uncertainty (%)

0.0 15 Value 0.00 0.04 0.23 - 0.46 -

Uncertainty ±0.22 +0.00 +0.05 - +0.31 -

20.0 15 Value 0.11 0.05 0.68 3.4 1.45 7.2

Uncertainty ±0.92 +0.00 +0.02 - +0.96 -

99.0 15 Value 0.54 0.11 0.72 0.7 1.95 2.0

Uncertainty ±0.93 +0.01 +0.04 - +1.01 -

BiasSec.ref(Micro) = BiasSec.ref(Macro) + BiasMicro

- = not applicable

FMetHb performance test results

Setup: Adult blood samples. HbF correction is not enabled.

BiasPrim.ref for FMetHb

FMetHb (%) ctHb (g/dL) BiasPrim.ref N (number of samples analyzed)

0.0 15 0.23 45

20.0 15 –0.13 45

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BiasPrim.ref = BiasSec.ref + BiasABL735-Prim.ref

65 µL: Performance characteristics for FMetHb – blood samples

FMetHb (%) ctHb Value and BiasSec.ref S0 SX CVX % TEA TEA

(g/dL) uncertainty (%)

0.0 15 Value -0.04 0.10 0.27 - 0.56 -

Uncertainty ±0.17 +0.01 +0.04 - +0.25 -

5.0 15 Value 0.02 0.09 0.27 5.5 0.56 11.2

Uncertainty ±0.19 +0.01 +0.04 - +0.26 -

10.0 15 Value –0.04 0.12 0.35 3.5 0.74 7.4

Uncertainty ±0.19 +0.01 +0.07 - +0.32 -

20.0 15 Value –0.18 0.09 0.29 1.4 0.74 3.7

Uncertainty ±0.22 +0.01 +0.03 - +0.28 -

30.0 15 Value –0.26 0.09 0.29 1.0 0.84 2.8

Uncertainty ±0.25 +0.01 +0.02 - +0.28 -

50.0 15 Value –0.21 0.09 0.34 0.7 0.89 1.8

Uncertainty ±0.31 +0.01 +0.01 - +0.33 -

99.0 15 Value 0.11 0.06 0.48 0.5 1.05 1.1

Uncertainty ±0.46 +0.00 +0.01 - +0.48 -

45 µL: Performance characteristics for FMetHb – blood samples

FMetHb ctHb Value and BiasSec.ref(Micro) S0 Sx CVX % TEA TEA

(%) (g/dL) uncertainty (%)

0.0 15 Value –0.04 0.10 0.34 - 0.71 -

Uncertainty ±0.24 +0.01 +0.08 - +0.39 -

10.0 15 Value –0.04 0.09 0.40 4.5 0.82 8.2

Uncertainty ±0.28 +0.01 +0.08 - +0.42 -

99.0 15 Value 0.11 0.11 0.49 0.5 1.07 1.1

Uncertainty ±0.65 +0.01 +0.01 - +0.66 -

BiasSec.ref(Micro) = BiasSec.ref(Macro) + BiasMicro

- = not applicable

FHHb performance test results

Setup: Adult blood samples. HbF correction is not enabled.

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65 µL: Performance characteristics for FHHb – blood samples

FHHb ctHb (g/dL) Value and BiasSec.ref S0 Sx CVX % TEA TEA

(%) uncertainty (%)

0.0 15 Value 0.07 0.10 0.28 - 0.61 -

Uncertainty ±0.17 +0.01 +0.05 - +0.27 -

10.0 15 Value 0.08 0.18 0.36 3.6 0.78 7.8

Uncertainty ±0.21 +0.01 +0.05 - +0.31 -

25.0 15 Value 0.05 0.30 0.48 1.9 1.00 4.0

Uncertainty ±0.30 +0.02 +0.03 - +0.35 -

35.0 15 Value 0.08 0.27 0.50 1.4 1.06 3.0

Uncertainty ±0.31 +0.02 +0.05 - +0.40 -

50.0 15 Value 0.11 0.26 0.57 1.1 1.23 2.5

Uncertainty ±0.31 +0.02 +0.05 - +0.42 -

100.0 15 Value -0.14 0.16 0.40 0.4 0.92 0.9

Uncertainty ±0.27 +0.01 +0.03 - +0.34 -

0.0 7 Value -0.45 0.13 0.36 - 1.16 -

Uncertainty ±0.16 +0.01 +0.08 - +0.32 -

0.0 25 Value 0.53 0.09 0.26 - 1.04 -

Uncertainty ±0.16 +0.01 +0.05 - +0.25 -

45 µL: Performance characteristics for FHHb – blood samples

FHHb ctHb Value and BiasSec.ref(Micro) S0 Sx CVX % TEA TEA

(%) (g/dL) uncertainty (%)

0.0 15 Value 0.07 0.07 0.25 - 0.56 -

Uncertainty ±0.24 +0.00 +0.04 - +0.32 -

25.0 15 Value 0.05 0.18 0.40 1.6 0.84 3.4

Uncertainty ±0.43 +0.01 +0.02 - +0.46 -

100.0 15 Value –0.14 0.07 0.29 0.3 0.70 0.7

Uncertainty ±0.38 +0.00 +0.00 - +0.39 -

BiasSec.ref(Micro) = BiasSec.ref(Macro) + BiasMicro

- = not applicable

FHbF performance test results

Setup: Mixed adult and fetal blood samples. HbF correction enabled for all levels.

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65 µL: Performance characteristics for FHbF – blood samples

FHbF ctHb (g/dL) Value and BiasPrim.ref* S0 SX CVX % TEA TEA (%)
(%) uncertainty

0 15 Value –3.4 1.5 5.4 - 13.9 -

Uncertainty ±3.0 +0.1 +1.0 - +4.9 -

5 15 Value –3.4 1.5 5.0 100.8 13.3 265.6

Uncertainty ±3.0 +0.1 +0.9 - +4.8 -

10 15 Value –4.3 1.4 5.0 50.2 14.2 141.5

Uncertainty ±3.1 +0.1 +0.9 - +4.8 -

20 15 Value –4.6 1.4 5.4 27.0 15.2 75.9

Uncertainty ±3.2 +0.1 +1.0 - +5.1 -

30 15 Value –5.0 1.4 5.4 18.0 15.6 51.9

Uncertainty ±3.2 +0.1 +0.9 - +4.9 -

50 15 Value –4.7 1.5 5.4 10.9 15.4 30.7

Uncertainty ±3.4 +0.1 +1.0 - +5.4 -

80 15 Value –3.4 1.4 5.2 6.4 13.5 16.9

Uncertainty ±3.5 +0.1 +0.6 - +4.8 -

45 µL: Performance characteristics for FHbF – blood samples

FHbF ctHb Value and BiasPrim.ref(Micro)* S0 Sx CVX % TEA TEA (%)

(%) (g/dL) uncer-
tainty

0 15 Value –3.5 1.3 5.1 - 13.5 -

Uncertainty ±4.3 +0.1 +1.0 - +6.2 -

30 15 Value –4.6 1.3 5.5 18.3 15.4 51.3

Uncertainty ±4.5 +0.1 +1.1 - +6.7 -

80 15 Value –3.4 1.5 5.9 7.4 15.0 18.7

Uncertainty ±5.0 +0.1 +1.2 - +7.3 -

BiasPrim.ref(Micro) = BiasPrim.ref(Macro) + BiasMicro

- = not applicable

* ABL735 corrected to HPLC through:

-1
æ g ö
HbF(corr) = 0.949%-1 ´ HbF(ABL735) + 0.930 ç ÷ ´ tHb(ABL735) - 9.34%
è dL ø

ctBil performance test results

Setup: HbF correction is not enabled.

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BiasPrim.ref for bilirubin

ctBil (µmol/L) ctHb (g/dL) BiasPrim.ref N (number of samples analyzed)

0 15 –3.3 3

200 15 –6.2 3

400 15 –6.5 3

BiasPrim.ref = BiasSec.ref + BiasABL735-Prim.ref

65 µL: Performance characteristics for ctBil in adult/fetal blood, pH = 7.4 ±0.1,

normal MCHC and albumin variation, spiked with unconjugated bilirubin

ctBil ctHb Values BiasSec.ref(Macro) S0 Sx CVX TEA TEA

(µmol/L) (g/dL) and % (%)
uncer-
tainty

8 15 Values 1.0 2.7 8.6 107.9 17.9 224.0

Uncer- ±5.2 +0.2 +1.7 - +8.5 -

tainty

100 15 Values 0.2 3.2 11.6 11.6 22.9 22.9

Uncer- ±6.9 +0.2 +2.3 - +11.3 -

tainty

200 15 Values –4.8 3.6 14.2 7.1 32.6 16.3

Uncer- ±8.5 +0.3 +2.8 - +14.1 -

tainty

400 15 Values –5.3 4.8 16.7 4.2 38.1 9.5

Uncer- ±12.1 +0.3 +2.4 - +16.9 -

tainty

600 15 Values –11.7 5.9 21.1 3.5 53.0 8.8

Uncer- ±15.7 +0.4 +2.8 - +21.1 -

tainty

45 µL: Performance characteristics for ctBil in adult/fetal blood, pH = 7.4 ±0.1,

normal MCHC and albumin variation, spiked with unconjugated bilirubin

ctBil ctHb Value BiasSec.ref(Micro) S0 Sx CVX TEA TEA

(µmol/L) (g/dL) and % (%)
uncer-
tainty

8 15 Values 1.0 2.2 9.9 123.9 20.4 255.4

Uncer- ±7.4 +0.2 +2.3 - +11.9 -

tainty

100 15 Values 0.2 2.2 10.9 10.9 21.6 21.6

Uncer- ±9.7 +0.2 +1.9 - +13.5 -

tainty

600 15 Values –11.7 4.0 17.2 2.9 45.4 7.6

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45 µL: Performance characteristics for ctBil in adult/fetal blood, pH = 7.4 ±0.1,

normal MCHC and albumin variation, spiked with unconjugated bilirubin

ctBil ctHb Value BiasSec.ref(Micro) S0 Sx CVX TEA TEA

(µmol/L) (g/dL) and % (%)
uncer-
tainty

600 15 Uncer- ±22.1 +0.3 +0.9 - +23.8 -

tainty

BiasSec.ref(Micro) = BiasSec.ref(Macro) + BiasMicro

- = not applicable

ctBil external test results

The purpose of the bilirubin external tests was to make a regression study of ABL90
FLEX PLUS bilirubin against reference hospital analyzers on hospital neonatal blood
samples.

A limited study was performed on hospital adult samples [12].

For The allowed analytical error is ±10 % to meet average clinical requirements for
neonatal bilirubin measurement [13,14,15,16,17].
use:
For whole blood the analytical error on the ABL90 FLEX PLUS analyzer is slightly
higher.

For adult • Adult samples within reference range: The uncertainty in the bilirubin measure-
use: ment on blood can, in some cases, exceed the level required to measure
normal bilirubin levels for children older than 3 months and adults (bilirubin
reference range 4-22 µmol/L).
• Adult samples with an increased bilirubin level: External tests using adult
samples were performed on samples with typically 80 % of the total bilirubin in
the conjugated form. For these highly conjugated samples the external tests
showed a negative bias of 18 % on blood samples.

The patient samples represented typical variations in ctBil, ctHb, sO2, pH and MCHC
(Mean Corpuscular Hemoglobin Concentration) values.

Three external tests were carried out at two different sites. Each test had its own
ABL90 FLEX PLUS analyzer - a total of three.

Wet Chemistry analyzer Roche Modular with Roche Calibrator was used as a reference
[18]. Each external test site had two Modulars - a total of four. ctBil was measured in
µmol/L.

The field test results are given below:

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1 ABL90 FLEX PLUSanalyzer

2 Reference analyzer

N (number of measurement) = 175

y = 1.014x - 0.828

R2 = 0.985

Syx = 11.6

Syx is the spreading around the line.

Actual external test from neonatal critical care hospitals that use blood. Data from
three field tests are merged. Values are in µmol/L.

The same data as above but depicted in a Bland-Altman plot below.

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1 Difference

Lines indicate Mean and ±15 µmol or 10 %. Values are in µmol/L. Difference = ABL90
FLEX PLUS analyzer - Modular.

cUrea performance test results

65 µL: Performance characteristics for cUrea – blood samples on analyzers configured

to feature creatinine and urea/BUN

cUrea Value and BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mmol/L) uncertainty

2.0 Value 0.01 0.03 0.10 4.9 0.20 10.0

Uncertainty ±0.03 +0.00 +0.01 - +0.04 -

5.0 Value –0.12 0.05 0.19 3.9 0.50 10.0

Uncertainty ±0.04 +0.00 +0.02 - +0.07 -

7.0 Value -0.03 0.07 0.27 3.9 0.56 8.0

Uncertainty ±0.04 +0.00 +0.03 - +0.10 -

10.0 Value –0.11 0.09 0.30 3.0 0.70 7.0

Uncertainty ±0.06 +0.01 +0.02 - +0.09 -

20.0 Value –1.59 0.11 0.68 3.4 2.93 14.6

Uncertainty ±0.10 +0.01 +0.10 - +0.30 -

42.0 Value –2.82 0.29 1.08 2.6 4.94 11.8

Uncertainty ±0.15 +0.02 +0.11 - +0.36 -

- = not applicable

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cBUN performance test results

Macromode: BiasPrim.ref and repeatability for cBUN – blood samples on analyzers

configured to feature creatinine and urea/BUN

cBUN Value and BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(mg/dL) uncertainty

5.6 Value 0.03 0.04 0.26 4.7 0.54 9.7

Uncertainty ±0.07 +0.00 +0.02 - +0.11 -

14 Value –0.35 0.13 0.54 3.9 1.40 10.0

Uncertainty ±0.10 +0.01 +0.06 - +0.21 -

20 Value -0.08 0.19 0.76 3.8 1.56 7.8

Uncertainty ±0.11 +0.01 +0.09 - +0.29 -

28 Value –0.32 0.25 0.84 3.0 1.96 7.0

Uncertainty ±0.16 +0.01 +0.06 - +0.27 -

56 Value –4.45 0.30 1.92 3.4 8.21 14.7

Uncertainty ±0.29 +0.02 +0.28 - +0.84 -

118 Value –7.9 0.09 3.0 2.6 13.9 11.8

Uncertainty +0.4 +0.1 +0.3 - +1.0 -

NOTE: S0 and Sx cannot be converted directly between Urea and BUN due to differ-
ences caused by rounding off these parameters. The differences caused by rounding
also cause the resulting CV to differ between Urea and BUN.

- = not applicable

cCrea performance test results

65 µL: Performance characteristics for cCrea – blood samples on analyzers configured

to feature creatinine and urea/BUN

cCrea Value and BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(µM) uncer-
tainty

35 Value –0.0 0.4 2.3 6.7 4.6 13.1

Uncertainty ±0.9 +0.0 +0.0 - +1.0 -

50 Value –0.2 0.4 2.2 4.5 4.6 9.2

Uncertainty ±0.7 +0.0 +0.1 - +0.9 -

100 Value –1.9 0.8 4.6 4.6 10.8 10.8

Uncertainty ±1.2 +0.0 +0.4 - +2.1 -

300 Value –12.2 2.4 10.6 3.5 33.0 11.0

Uncertainty ±2.3 +0.1 +0.7 - +3.7 -

600 Value –21.1 4.9 25.2 4.2 70.5 11.7

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65 µL: Performance characteristics for cCrea – blood samples on analyzers configured

to feature creatinine and urea/BUN

cCrea Value and BiasPrim.ref S0 Sx CVX % TEA TEA(%)

(µM) uncer-
tainty

600 Uncertainty ±7.3 +0.3 +1.4 - +10.0 -

900 Value –37.0 5.2 35.2 3.9 106.0 11.8

Uncertainty ±8.9 +0.3 +1.9 - +12.6 -

- = not applicable

Precision and bias of aqueous QC system – QUALICHECK7+

The data in the following tables are typical performance values for the ABL90 FLEX and
ABL90 FLEX PLUS analyzers and can be used when performing user verification tests of
the measuring performance of these analyzers.

The data was generated using five levels of QUALICHECK7+ material. Testing was
conducted according to the CLSI guideline EP15-A3, User Verification of Precision and
Estimation of Bias; Approved Guideline – 3rd Edition. It consisted of five replicates
measured once a day on each level over five days on 20 ABL90 FLEX PLUS analyzers,
resulting in 500 measurements on each level. The QUALICHECK7+ ampoules were
equilibrated at 25 °C prior to measurements. The test was performed in calibra-
tion-verification mode.

When conducting a user verification test of the measurement performance of ABL90

FLEX and ABL90 FLEX PLUS analyzers, Radiometer recommends following the guideline
CLSI EP15-A3. The precision values obtained in the user verification test should be
evaluated against the typical values in the tables by using the comparison method
described in the guideline. The bias values obtained in the user verification test should
fall within the intervals given in the tables. It is recommended to perform this test
using at least two levels of QUALICHECK7+ and to always include Level 2, as this
presents the normal values for all parameters. Calculations can be performed with soft-
ware programs available for EP15-A3.

For important details on measurement and management of Quality Control and Cali-
bration Verification on the ABL90 FLEX and ABL90 FLEX PLUS analyzers, see Chapter 5,
Quality control.

σR (repeatability) and σWL are defined in EP-15-A3.

The bias acceptance range is the interval relative to the assigned value. The ± sign
indicates that the bias is accepted if it is numerically less than the stated acceptance
range, i.e. irrespective of direction.

QC7+, Level 0

Para- Unit Assigned Bias (±) σR CVR σWL CVWL

meter value

pH N/A 6.742 0.0173 0.0021 0.0 % 0.0038 0.1 %

pCO2 mmHg 106 6.3 1.0 0.9 % 1.3 1.2 %

pO2 mmHg 7.7 11.72 1.13 14.5 % 1.64 21.1 %

cNa+ mM 94 3.3 0.3 0.3 % 0.3 0.4 %

cK+ mM 1.5 0.24 0.03 1.9 % 0.03 2.0 %

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Para- Unit Assigned Bias (±) σR CVR σWL CVWL

meter value

cCl– mM 71 5.2 0.3 0.4 % 0.4 0.6 %

cCa2+ mM 2.62 0.121 0.012 0.5 % 0.015 0.6 %

cGlu mM 0.0 0.41 0.04 - 0.04 -

cLac mM 0.0 0.32 0.03 - 0.04 -

cCrea* µM 38 2.1 1.3 3.5 % 2.5 6.5 %

cUrea* mM 2.1 0.20 0.04 2.0 % 0.05 2.3 %

cBUN*/** mg/dL 5.9 0.61 0.09 1.5 % 0.12 2.0 %

ctHb g/dL 0.00 0.076 0.011 - 0.012 -

ctBil µM 0 3.7 1.0 - 1.2 -

* Parameters only available on analyzers configured to feature creatinine and

Urea/BUN.

** σR and σWL cannot be converted directly between Urea and BUN due to differences
caused by rounding of these parameters. The differences caused by rounding also
cause the resulting CV to differ between Urea and BUN.

- = not applicable

QC7+, Level 1

Para- Unit Assigned Bias (±) σR CVR σWL CVWL

meter value

pH N/A 7.194 0.0161 0.0014 0.0 % 0.0019 0.0 %

pCO2 mmHg 69.7 2.92 0.65 0.9 % 1.04 1.5 %

pO2 mmHg 39.2 7.29 0.80 2.0 % 1.36 3.5 %

cNa+ mM 125 3.4 0.3 0.2 % 0.3 0.3 %

cK+ mM 6.1 0.24 0.03 0.5 % 0.03 0.5 %

cCl– mM 92 5.2 0.3 0.3 % 0.4 0.4 %

cCa2+ mM 1.55 0.084 0.006 0.4 % 0.008 0.5 %

cGlu mM 26 1.7 0.5 2.1 % 0.6 2.4 %

cLac mM 15 1.5 0.3 2.3 % 0.5 3.0 %

cCrea* µM 399 47.1 10.6 2.6 % 16.5 4.1 %

cUrea* mM 13.6 1.91 0.22 1.6 % 0.34 2.5 %

cBUN*/** mg/dL 38.1 5.36 0.62 1.6 % 0.96 2.5 %

ctHb g/dL 4.8 0.32 0.03 0.6 % 0.04 0.8 %

sO2 % 1.6 0.96 0.09 5.6 % 0.27 17.0 %

FO2Hb % 0.7 0.73 0.06 8.0 % 0.13 19.1 %

FCOHb % 51.6 1.74 0.06 0.1 % 0.13 0.3 %

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Para- Unit Assigned Bias (±) σR CVR σWL CVWL

meter value

FMetHb % 6.3 0.77 0.05 0.9 % 0.12 1.8 %

ctBil µM 111 9.7 0.4 0.4 % 0.7 0.6 %

* Parameters only available on analyzers configured to feature creatinine and

Urea/BUN.

** σR and σWL cannot be converted directly between Urea and BUN due to differences
caused by rounding of these parameters. The differences caused by rounding also
cause the resulting CV to differ between Urea and BUN.

QC7+, Level 2

Para- Unit Assigned Bias (±) σR CVR σWL CVWL

meter value

pH N/A 7.399 0.0157 0.0015 0.0 % 0.0021 0.0 %

pCO2 mmHg 42.1 1.75 0.34 0.8 % 0.63 1.5 %

pO2 mmHg 100 6.4 1.2 1.2 % 1.8 1.8 %

cNa+ mM 140 3.4 0.3 0.2 % 0.3 0.2 %

cK+ mM 4.0 0.24 0.03 0.7 % 0.03 0.7 %

cCl– mM 99 5.3 0.3 0.3 % 0.3 0.3 %

cCa2+ mM 1.21 0.088 0.005 0.4 % 0.006 0.5 %

cGlu mM 9.8 1.51 0.10 1.0 % 0.15 1.5%

cLac mM 1.4 0.43 0.03 2.3 % 0.04 2.6 %

cCrea* µM 176 19.2 3.7 2.1 % 5.4 3.1%

cUrea* mM 4.8 0.68 0.09 1.8 % 0.11 2.3 %

cBUN*/** mg/dL 13.4 1.92 0.23 1.7 % 0.30 2.2 %

ctHb g/dL 13.0 0.48 0.03 0.3 % 0.06 0.5 %

sO2 % 97.1 0.64 0.07 0.1 % 0.18 0.2 %

O2Hb % 92.2 0.85 0.06 0.1 % 0.07 0.1 %

COHb % 3.1 1.59 0.07 2.3 % 0.21 6.7 %

MetHb % 2.0 0.84 0.05 2.7 % 0.08 4.1 %

HbF % 82 8.8 0.9 1.1 % 3.1 3.8 %

ctBil µM 300 12.4 0.5 0.2 % 1.3 0.4 %

* Parameters only available on analyzers configured to feature creatinine and

Urea/BUN.

** σR and σWL cannot be converted directly between Urea and BUN due to differences
caused by rounding of these parameters. The differences caused by rounding also
cause the resulting CV to differ between Urea and BUN.

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QC7+, Level 3

Para- Unit Assigned Bias (±) σR CVR σWL CVWL

meter value

pH N/A 7.596 0.0192 0.0017 0.0 % 0.0029 0.0 %

pCO2 mmHg 21.1 1.23 0.25 1.2 % 0.39 1.8 %

pO2 mmHg 141 5.8 1.4 1.0 % 2.1 1.5 %

cNa+ mM 160 3.3 0.3 0.2 % 0.3 0.2 %

cK+ mM 8.0 0.23 0.03 0.4 % 0.03 0.4 %

cCl– mM 141 5.0 0.3 0.2 % 0.5 0.3 %

cCa2+ mM 0.75 0.09 0.004 0.5 % 0.005 0.7 %

cGlu mM 2.4 0.38 0.04 1.8 % 0.06 2.4 %

cLac mM 5.9 0.60 0.05 0.9 % 0.10 1.7 %

cCrea* µM 562 47.9 13.9 2.5 % 19.0 3.4 %

cUrea* mM 30.2 2.19 0.79 2.6 % 1.66 5.5 %

cBUN*/** mg/dL 84.6 6.13 2.22 2.6 % 4.64 5.5 %

ctHb g/dL 10.2 0.49 0.03 0.3 % 0.05 0.5 %

sO2 % 98.7 1.07 0.07 0.1 % 0.22 0.2 %

FO2Hb % 99.2 0.85 0.06 0.1 % 0.08 0.1 %

FCOHb % - 0.3 1.01 0.08 - 0.24 -

FMetHb % - 0.1 0.83 0.05 - 0.09 -

HbF % 10 7.4 1.0 10.4 % 3.8 37.9 %

ctBil µM 235 11.8 0.5 0.2 % 1.1 0.5 %

* Parameters only available on analyzers configured to feature creatinine and

Urea/BUN.

** σR and σWL cannot be converted directly between Urea and BUN due to differences
caused by rounding of these parameters. The differences caused by rounding also
cause the resulting CV to differ between Urea and BUN.

- = not applicable

QC7+, Level 4

Para- Unit Assigned Bias (±) σR CVR σWL CVWL

meter value

pH N/A 7.839 0.0210 0.0023 0.0 % 0.0045 0.1 %

pCO2 mmHg 11.5 1.1 0.29 2.5 % 0.45 3.9 %

pO2 mmHg 537 24.0 11.2 2.1 % 13.0 2.4 %

cNa+ mM 189 3.2 0.3 0.2 % 0.4 0.2 %

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Para- Unit Assigned Bias (±) σR CVR σWL CVWL

meter value

cK+ mM 10.5 0.21 0.03 0.3 % 0.04 0.4 %

cCl– mM 160 4.2 0.4 0.2 % 0.9 0.6 %

cCa2+ mM 0.38 0.087 0.004 0.9 % 0.006 1.6 %

cGlu mM 47 4.0 0.8 1.7 % 1.0 2.2 %

cLac mM 30 4.1 0.5 1.5 % 0.7 2.4 %

cCrea* µM 687 55.2 20.0 2.9 % 25.4 3.7 %

cUrea* mM 40.8 3.84 1.07 2.6 % 2.13 5.2 %

cBUN*/** mg/dL 114 10.8 3.0 2.6 % 6.0 5.2 %

ctHb g/dL 26.8 1.19 0.05 0.2 % 0.10 0.4 %

sO2 % 82.5 1.25 0.05 0.1 % 0.12 0.2 %

FO2Hb % 80.5 0.85 0.06 0.1 % 0.08 0.1 %

FCOHb % - 0.4 1.67 0.06 - 0.17 -

FMetHb % 2.9 0.87 0.05 1.7 % 0.06 2.2 %

HbF % 34 13.4 0.3 1.0 % 0.8 2.4 %

ctBil µM 618 24.3 1.4 0.2 % 2.8 0.5 %

* Parameters only available on analyzers configured to feature creatinine and

Urea/BUN.

** σR and σWL cannot be converted directly between Urea and BUN due to differences
caused by rounding of these parameters. The differences caused by rounding also
cause the resulting CV to differ between Urea and BUN.

- = not applicable

Interference test results

Interference tests

Interfering substances were selected for the interference tests. The selection was
based on previous knowledge and where interference was thought to be possible.

Interference can be caused by these factors:

• chemical structure
• decomposition
• optical properties
• other properties that are relevant to take into account as given in [21].

Interference limits were selected for all parameters. The interference limit is the
concentration of the interfering substance that was used for the interference tests. The
tests used parameters at their normal physiological levels.

To determine the degree of interference, test results for a sample with and without an
added interferent were compared. The results from the interference tests are given as
the deviation from the correct result [22].

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pH/blood gas

These interference results are found for pH and blood gases:

Substance Test concentra- Interference on ... Test matrix

tion
pH (at pH ~ pCO2 mmHg (at pO2 mmHg (at
7.4) 30-60 mmHg) <100 mmHg)

Ca2+ 5.5 mmol/L <|0.010| N/A N/A Blood

Fluorescein 400 mg/L N/A N/A <|1| Blood

Hemolysis 2% <|0.010| <|0.5| <|1| Blood

5% <|0.010| <|0.5| <|1| Blood

10 % <|0.010| <|0.5| <|1| Blood

20 % <|0.010| <|0.5| -1.50 Blood

Intralipid 2 % (400 mg/dL) <|0.010| <|0.5| <|1| Blood/aqueous

5 % (1000 mg/dL) <|0.010| <|0.5| <|1| Blood/aqueous

K+ 17 mmol/L <|0.010| N/A N/A Blood

Na+ 190 mmol/L <|0.010| N/A N/A Blood

Bilirubin (conj) 400 µmol/L <|0.010| <|0.5| <|1| Blood

Bilirubin (unconj) 500 µmol/L <|0.010| <|0.5| <|1| Blood

Biotin 1200 ng/L <|0.010| <|0.5| <|1| Blood

N/A: Interference has not been measured on the respective parameter.

Numbers in brackets, i.e. <|1|: show that the interference lies within a range of ± the
number in the brackets, i.e. <|1| = an interference within ±1.

Electrolytes

These interference results are found for the electrolytes:

Substance Test Interference on ... Test matrix

concentra-
tion cK+ (at 4 cNa+ (at cCa2+ (at cCl– (at 105
mmol/L) 140 1.25 mmol/L)
mmol/L) mmol/L)

Acetylsalicylic 0.91 mmol/L N/A N/A N/A <|1| Plasma

acid
1.21 mmol/L N/A N/A N/A <|1| Plasma

1.81 mmol/L N/A N/A N/A 1.1 Plasma

3.62 mmol/L N/A N/A N/A 3.0 Plasma

Acetyl-trypto- 0.12 mmol/L N/A N/A N/A <|1| Plasma

phane

Ammonium 1 mmol/L <|0.1| <|1| N/A 1.1 Plasma

(NH4+)
107 µmol/L <|0.1| <|1| N/A <|1| Plasma

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Substance Test Interference on ... Test matrix

concentra-
tion cK+ (at 4 cNa+ (at cCa2+ (at cCl– (at 105
mmol/L) 140 1.25 mmol/L)
mmol/L) mmol/L)

Ascorbic acid 170 µmol/L N/A N/A N/A <|1| Plasma

850 µmol/L N/A N/A N/A <|1| Plasma

Benzalkonium 7.5 µg/mL 0.27 8.7 0.138 <|1| Plasma

chloride
10 µg/mL 0.39 12.1 0.182 <|1| Plasma

15 µg/mL 0.60 18.8 0.269 <|1| Plasma

30 µg/mL 1.28 40.4 0.622 <|1| Plasma

Bilirubin (conj) 400 µmol/L <|0.1| 1.31 <|0.02| <|1| Blood

Bilirubin (unconj) 500 µmol/L <|0.1| <|1| <|0.02| 1.01 Blood

Bromide (Br–) 37.5 mmol/L N/A N/A N/A 76.6 Plasma

18.75 N/A N/A N/A 37.6 Plasma

mmol/L

10 mmol/L N/A N/A N/A 19.5 Plasma

5 mmol/L N/A N/A N/A 10.1 Plasma

1 mmol/L N/A N/A N/A 1.8 Plasma

Calcium (Ca2+) 3.4 mmol/L <|0.1| 1.2 N/A N/A Plasma

2.2 mmol/L N/A <|1| N/A N/A Plasma

1.8 mmol/L N/A <|1| N/A N/A Plasma

1.6 mmol/L N/A <|1| N/A N/A Plasma

Caprylic acid 0.12 mmol/L N/A N/A N/A <|1| Plasma

Citrate 1 mmol/L N/A N/A N/A <|1| Plasma

40 mmol/L N/A N/A N/A –4.9 Plasma

Fluoride (F–) 107 µmol/L N/A N/A N/A <|1| Plasma

1 mmol/L N/A N/A N/A <|1| Plasma

Hemolysis 2% 1.32 –2.35 –0.085 1.57 Blood

5% 3.63 –5.16 –0.159 2.27 Blood

10 % 6.77 –8.56 –0.232 1.20 Blood

20 % 12.68 –15.14 –0.372 <|1| Blood

Intralipid 2 % (400 <|0.1| <|1| <|0.02| <|1| Plasma

mg/dL)

5 % (1000 <|0.1| 2.4 <|0.02| 1.7 Plasma

mg/dL)

Iodide (I–) 2.99 mmol/L N/A N/A N/A 12.4 Plasma

1.5 mmol/L N/A N/A N/A 5.3 Plasma

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Substance Test Interference on ... Test matrix

concentra-
tion cK+ (at 4 cNa+ (at cCa2+ (at cCl– (at 105
mmol/L) 140 1.25 mmol/L)
mmol/L) mmol/L)

Iodide (I–) 1 mmol/L N/A N/A N/A 3.5 Plasma

0.75 mmol/L N/A N/A N/A 2.5 Plasma

Lactate 25 mmol/L N/A N/A N/A <|1| Plasma

Leflunomide 75 μg/mL <|0.1| <|1| –0.05 <|1| Blood

= 75 mg/L

150 μg/mL –0.12 –1.46 –0.09 <|1| Blood

= 150 mg/L

225 μg/mL –0.20 –2.15 –0.14 <|1| Blood

= 225 mg/L

300 μg/mL –0.29 –2.83 –0.19 <|1| Blood

= 300 mg/L

Biotin 1200 ng/L <|0.1| <|1| <|0.02| N/A Blood

Lithium (Li+) 3.2 mmol/L <|0.1| <|1| <|0.02| N/A Plasma

Magnesium 15 mmol/L N/A <|1| –0.023 N/A Aqueous

(Mg2+)

Nortriptyline 500 ng/mL <|0.1| <|1| <|0.02| <|1| Blood

= 0.5 mg/L

Oxalate 1 mmol/L N/A N/A N/A <|1| Plasma

10 mmol/L N/A N/A N/A <|1| Plasma

Perchlorate 0.375 N/A N/A N/A 2.1 Plasma

(ClO4–) mmol/L

0.5 mmol/L N/A N/A N/A 2.5 Plasma

0.75 mmol/L N/A N/A N/A 3.7 Plasma

1.5 mmol/L N/A N/A <|0.02| 7.3 Plasma

pH 6.8-8 N/A N/A –0.037 N/A Aqueous/buffer

mmol/L / pH

N/A N/A N/A <|1| Plasma

Potassium (K+) 12 mmol/L N/A <|1| <|0.02| N/A Plasma

Salicylic acid 1.09 mmol/L N/A N/A N/A <|1| Plasma

1.45 mmol/L N/A N/A N/A <|1| Plasma

2.17 mmol/L N/A N/A N/A 1.7 Plasma

4.34 mmol/L N/A N/A N/A 5.2 Plasma

Sodium (Na+) 180 mmol/L N/A N/A 0.029 N/A Plasma

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Substance Test Interference on ... Test matrix

concentra-
tion cK+ (at 4 cNa+ (at cCa2+ (at cCl– (at 105
mmol/L) 140 1.25 mmol/L)
mmol/L) mmol/L)

Strontium (Sr2+) 150 µmol/L N/A N/A <|0.02| N/A Plasma

Teriflunomide 75 μg/mL –0.11 <|1| <|0.02| <|1| Blood

= 75 mg/L

150 μg/mL –0.26 <|1| <|0.02| <|1| Blood

= 150 mg/L

225 μg/mL –0.44 –1.40 –0.044 <|1| Blood

= 225 mg/L

300 μg/mL –0.70 –3.34 –0.112 <|1| Blood

= 300 mg/L

Thiocyanic acid 0.43 mmol/L N/A N/A N/A 4.8 Plasma

0.57 mmol/L N/A N/A N/A 5.5 Plasma

0.86 mmol/L N/A N/A N/A 8.7 Plasma

1.72 mmol/L N/A N/A N/A 17.2 Plasma

Zinc (Zn2+) 170 μmol/L <|0.1| <|1| 0.024 N/A Plasma

N/A: Interference has not been measured on the respective parameter

* Depending on the pH level

Numbers in brackets, i.e. <|1|: show that the interference lies within a range of ± the
number in the brackets, i.e. <|1| = an interference within ±1.

Metabolites

These interference results are found for the metabolites:

cGlu - cLac Interference on... Test matrix

Substance Test concentra- cGlu (at 4.0 mmol/L) cLac (at 1.5 mmol/L)
tion

Acetaminophen = 2 mmol/L <|0.1| <|0.1| Blood

paracetamol

Acetoacetate 2 mmol/L <| 0.1| 0.11 Blood

(lithium acetoace-
tate)

Acetylsalicylic acid 3.62 mmol/L <| 0.1| <|0.1| Blood

Ascorbic acid 170 µmol/L <| 0.1| <|0.1| Blood

Bilirubin (conj) 0.2 g/L <|0.1| <|0.1| Blood

Bilirubin (unconj) 0.2 g/L <|0.1| <|0.1| Blood

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cGlu - cLac Interference on... Test matrix

Substance Test concentra- cGlu (at 4.0 mmol/L) cLac (at 1.5 mmol/L)
tion

Chlorpromazine 0.2 mmol/L <| 0.1| <|0.1| Blood

HCl

Citrate (trisodium 1 mmol/L <|0.1| <|0.1| Blood

citrate 2H2O)
2.5 mmol/L <|0.1| <|0.1| Blood

5 mmol/L <|0.1| <|0.1| Blood

7.5 mmol/L –0.10 <|0.1| Blood

10 mmol/L –0.11 –0.11 Blood

Creatinine 3 mmol/L <|0.1| <|0.1| Blood

2-deoxy Glucose 2.5 mmol/L 2.25 N/A Blood

3.33 mmol/L 2.88 N/A Blood

5 mmol/L 4.58 N/A Blood

10 mmol/L 9.58 <|0.1| Blood

Dopamine HCl 1 mmol/L <|0.1| <|0.1| Blood

D-Glucose 67 mmol/L N/A –0.21 Blood

EDTA (edetate 3 mmol/L <|0.1| <|0.1| Blood

disodium 2H2O)

Ethanol 87 mmol/L <|0.1| <|0.1| Blood

Fluoride (sodium 50 mmol/L –0.12 –0.13 Blood

fluoride)

Formaldehyde 10 mmol/L <|0.1| <|0.1| Blood

Formic acid 25 mmol/L <|0.1| <|0.1| Blood

Galactose 3.3 mmol/L 0.14 <|0.1| Blood

Glucosamine HCl 2 mmol/L 0.12 <|0.1| Blood

Glycolic acid 0.25 mmol/L N/A 0.31 Blood

0.33 mmol/L N/A 0.39 Blood

0.5 mmol/L N/A 0.48 Blood

1 mmol/L <|0.1| 0.52 Blood

Hemolysis 2% 0.28 <|0.1| Blood

(% is based on a 5% 0.17 0.15 Blood

standard sample of
15 g/dL) 10 % 0.21 <|0.1| Blood

20 % 0.24 <|0.1| Blood

Heparin 8000 iu/dL <|0.1| <|0.1| Blood

Ibuprofen 2.5 mmol/L <|0.1| <|0.1| Blood

(sodium)

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cGlu - cLac Interference on... Test matrix

Substance Test concentra- cGlu (at 4.0 mmol/L) cLac (at 1.5 mmol/L)
tion

Intralipid 2 % (400 mg/dL) <|0.1| <|0.1| Blood

5 % (1000 mg/dL) <|0.1| <|0.1| Blood

Lactic acid 12 mmol/L <|0.1| N/A Blood

Maltose (monohy- 5 mmol/L <|0.1| <|0.1| Blood

drate)

Mannose 1 mmol/L 0.11 <|0.1| Blood

Methanol 75 mmol/L <|0.1| <|0.1| Blood

N-acetylcystein 1.28 mmol/L <|0.1| <|0.1| Blood

2.55 mmol/L <|0.1| <|0.1| Blood

3.83 mmol/L <|0.1| –0.12 Blood

5.1 mmol/L <|0.1| –0.20 Blood

7.65 mmol/L <|0.1| –0.29 Blood

10.2 mmol/L <|0.1| –0.38 Blood

Oxalate (sodium 1 mmol/L <|0.1| <|0.1| Blood

oxalate)

Pralidoxime 0.045 mmol/L <|0.1| <|0.1| Blood

chloride

Pyruvate (pyruvic 2 mmol/L <|0.1| <|0.1| Blood

acid sodium salt)

Salicylic acid 4.34 mmol/L <|0.1| <|0.1| Blood

Sodium thiocya- 6 mmol/L 14.39 10.95 Blood

nate
8 mmol/L 19.31 14.57 Blood

12 mmol/L 31.08 21.91 Blood

24 mmol/L 94.69 58.75 Blood

Urea 84 mmol/L <|0.1| <|0.1| Blood

Uric acid 1.5 mmol/L <|0.1| <|0.1| Blood

Xylose 1 mmol/L <|0.1| <|0.1| Blood

Povidone-iodine 0.035 g/L ~ <|0.1| N/A Blood

10 % solution (10 0.0035 % PI

g/dL)
2.5 g/L ~ 0.25 % 0.22 N/A Blood
PI

5 g/L ~ 0.5 % PI 0.43 N/A Blood

7.5 g/L ~ 0.75 % 0.54 N/A Blood

PI

10 g/L ~ 1 % PI 0.69 N/A Blood

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cGlu - cLac Interference on... Test matrix

Substance Test concentra- cGlu (at 4.0 mmol/L) cLac (at 1.5 mmol/L)
tion

Biotin 1200 ng/L <|0.1| <|0.1| Blood

cCrea Interference on... Test matrix

Substance Test concentra- cCrea low (at 133 cCrea high (at 442
tion μM) μM)

Acetaminophen = 1.324 mmol/L <|6 %| <|6 %| Blood

paracetamol

Acetylsalicylic acid 3.62 mmol/L <|6 %| <|6 %| Blood

Ascorbate 0.342 mmol/L <|6 %| <|6 %| Blood

(sodium-)

Bacitracin 0.005 mmol/L <|6 %| <|6 %| Blood

β-hydroxybutyrate 2.5 mmol/L N/A <|6 %| Blood

5 mmol/L N/A <|6 %| Blood

7.5 mmol/L N/A <|6 %| Blood

10 mmol/L <|6 %| <|6 %| Blood

Bilirubin (conj) 342 μmol/L <|6 %| <|6 %| Blood

Bilirubin (unconj) 342 μmol/L <|6 %| <|6 %| Blood

Biotin 1200 ng/L <|6 %| <|6 %| Blood

Bromide (sodium-) 9.4 mmol/L <|6 %| <|6 %| Blood

18.8 mmol/L <|6 %| <|6 %| Blood

28.1 mmol/L <|6 %| <|6 %| Blood

37.5 mmol/L <|6 %| <|6 %| Blood

Cholesterol 13 mmol/L <|6 %| <|6 %| Blood

Ciprofloxacin 0.0302 <|6 %| <|6 %| Blood

Citrate (sodium-) 1 mmol/L N/A <|6 %| Blood

2 mmol/L N/A <|6 %| Blood

3 mmol/L N/A <|6 %| Blood

4 mmol/L N/A <|6 %| Blood

5 mmol/L <|6 %| N/A Blood

10 mmol/L -12.1 N/A Blood

15 mmol/L -11.5 N/A Blood

20 mmol/L -12.9 N/A Blood

Creatine 0.2 mmol/L <|6 %| <|6 %| Blood

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cCrea Interference on... Test matrix

Substance Test concentra- cCrea low (at 133 cCrea high (at 442
tion μM) μM)

Dobutamine 3 μmol/L <|6 %| <|6 %| Blood

(hydrochloride)

Dopamine (hydro- 5.87 μmol/L <|6 %| <|6 %| Blood

chloride)

Dobesilate 0.3 mmol/L <|6 %| <|6 %| Blood

(calcium)

EDTA 3.4 μmol/L <|6 %| <|6 %| Blood

Ethanol 86.8 mmol/L <|6 %| <|6 %| Blood

Fluoride (sodium-) 50 mmol/L <|6 %| <|6 %| Blood

Formaldehyde 0.133 mmol/L <|6 %| <|6 %| Blood

Glucose 55 mmol/L <|6 %| <|6 %| Blood

Gluthation - 2.55 mmol/L <|6 %| <|6 %| Blood

oxidized

Gluthation - 3 mmol/L <|6 %| <|6 %| Blood

reduced

Glycolic acid 0.25 mmol/L <|6 %| <|6 %| Blood

Guaiacol 0.4 mmol/L <|6 %| <|6 %| Blood

HCO3 - 30 mmol/L <|6 %| <|6 %| Blood

Hemoglobin 2 g/L <|6 %| <|6 %| Blood

(plasma)

HCT 21 % <|6 %| <|6 %| Blood

53 % <|6 %| <|6 %| Blood

60 % <|6 %| <|6 %| Blood

68 % -8.3 <|6 %| Blood

75 % -13.6 -38.6 Blood

Hemolysis 20 % (3.0 g/dL <|6 %| <|6 %| Blood

hemoglobin)

Heparin (sodium-) 3000 U/L <|6 %| <|6 %| Blood

Hydroxyurea 0.23 mmol/L <|6 %| <|6 %| Blood

0.46 mmol/L <|6 %| <|6 %| Blood

0.69 mmol/L <|6 %| <|6 %| Blood

0.92 mmol/L 11.5 <|6 %| Blood

Ibuprofen 2.425 mmol/L <|6 %| <|6 %| Blood

Intralipid 5 % (1000 mg/dL) <|6 %| <|6 %| Blood

Iodide (sodium-) 2.99 mmol/L <|6 %| <|6 %| Blood

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cCrea Interference on... Test matrix

Substance Test concentra- cCrea low (at 133 cCrea high (at 442
tion μM) μM)

Isoniazid 0.292 mmol/L <|6 %| <|6 %| Blood

Lactate 1.7 mmol/L N/A <|6 %| Blood

3.3 mmol/L N/A <|6 %| Blood

5.0 mmol/L N/A <|6 %| Blood

6.6 mmol/L <|6 %| <|6 %| Blood

Lactic acid 6.6 mmol/L <|6 %| <|6 %| Blood

L-Dopa 0.1 mmol/L <|6 %| <|6 %| Blood

Levofloxacin 48.6 μmol/L <|6 %| <|6 %| Blood

Lidocaine (hydro- 51.2 μmol/L <|6 %| <|6 %| Blood

chloride)

Methyldopa 71 μmol/L <|6 %| <|6 %| Blood

N-acetylcysteine 10.2 mmol/L <|6 %| <|6 %| Blood

pO2 30 mmHg <|6 %| <|6 %| Blood

(Reference level: 500 mmHg <|6 %| <|6 %| Blood

80 mmHg)

Oxalate (sodium-) 1 mmol/L <|6 %| <|6 %| Blood

pCO2 15 mmHg <|6 %| <|6 %| Blood

(Reference level: 20 mmHg <|6 %| <|6 %| Blood

40 mmHg)
27 mmHg <|6 %| <|6 %| Blood

35 mmHg <|6 %| <|6 %| Blood

54 mmHg <|6 %| <|6 %| Blood

69 mmHg <|6 %| <|6 %| Blood

85 mmHg <|6 %| <|6 %| Blood

100 mmHg <|6 %| <|6 %| Blood

Pentobarbital 354 μmol/L <|6 %| <|6 %| Blood

pH 6.80 <|6 %| <|6 %| Blood

(Reference level: 7.45 N/A <|6 %| Blood

pH 7.35)
7.50 <|6 %| <|6 %| Blood

7.60 <|6 %| <|6 %| Blood

7.70 N/A <|6 %| Blood

7.85 -10.1 -32.8 Blood

8.00 -15.4 N/A Blood

Povidone-iodine 1.37 mmol/L <|6 %| <|6 %| Blood

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cCrea Interference on... Test matrix

Substance Test concentra- cCrea low (at 133 cCrea high (at 442
tion μM) μM)

Proline 0.25 mmol/L <|6 %| <|6 %| Blood

Protein 76.3 g/L <|6 %| <|6 %| Blood

79.4 g/L N/A N/A Blood

82.5 g/L <|6 %| <|6 %| Blood

88.8 g/L <|6 %| N/A Blood

95 g/L <|6 %| <|6 %| Blood

107.5 g/L -8.1 <|6 %| Blood

120.0 g/L -10.0 <|6 %| Blood

Rifampicin 78.1 μmol/L <|6 %| <|6 %| Blood

Salicylate (salicylic 4.34 mmol/L <|6 %| <|6 %| Blood

acid)

Sarcosine 1 μmol/L <|6 %| <|6 %| Blood

Sodium thiosulfate 1.0 mmol/L N/A <|6 %| Blood

2.1 mmol/L N/A <|6 %| Blood

3.1 mmol/L N/A <|6 %| Blood

4.2 mmol/L <|6 %| <|6 %| Blood

8.4 mmol/L <|6 %| <|6 %| Blood

12.5 mmol/L <|6 %| <|6 %| Blood

16.7 mmol/L -8.3 <|6 %| Blood

Theophyllin 0.222 mmol/L <|6 %| <|6 %| Blood

Theophyllin acetic 0.2 mmol/L <|6 %| <|6 %| Blood

acid

Thiocyanate 6.88 mmol/L <|6 %| <|6 %| Blood

Tolbutamide 2.37 mmol/L <|6 %| <|6 %| Blood

Urea 42.9 mmol/L <|6 %| <|6 %| Blood

Uric acid 1.4 mmol/L <|6 %| <|6 %| Blood

cUrea Interference on... Test matrix

Substance Test concentra- cUrea low (at 3 cUrea high (at 7

tion mmol/L) mmol/L)

Acetaminophen = 1.324 mmol/L <|0.4| <|0.4| Blood

paracetamol

Acetazolamide 4 μmol/L N/A -0.44 Blood

8 μmol/L N/A -0.51 Blood

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cUrea Interference on... Test matrix

Substance Test concentra- cUrea low (at 3 cUrea high (at 7

tion mmol/L) mmol/L)

Acetazolamide 13 μmol/L N/A -0.51 Blood

17 μmol/L N/A -0.48 Blood

0.270 μmol/L <|0.4| -0.68 Blood

Acetoacetate 10 mmol/L <|0.4| <|0.4| Blood

(lithium-)

Acetylsalicylic acid 3.62 mmol/L <|0.4| <|0.4| Blood

Ammonium 107 μmol/L <|0.4| <|0.4| Blood

Chloride

Ascorbate 342 μmol/L <|0.4| <|0.4| Blood

(sodium-)

Benzalkonium 20.75 μmol/L <|0.4| <|0.4| Blood

chloride
41.5 μmol/L <|0.4| -0.45 Blood

62.25 μmol/L -0.53 -0.65 Blood

83 μmol/L -0.70 -0.89 Blood

β-hydroxybutyrate 2.5 mmol/L N/A <|0.4| Blood

5 mmol/L N/A 0.57 Blood

7.5 mmol/L N/A 0.75 Blood

10 mmol/L <|0.4| 0.85 Blood

Bilirubin conju- 342 μmol/L <|0.4| <|0.4| Blood

gated

Bilirubin unconju- 342 μmol/L <|0.4| <|0.4| Blood

gated

Biotin 1200 ng/L <|0.4| <|0.4| Blood

Boric Acid 1 mmol/L <|0.4| <|0.4| Blood

Bromide (sodium-) 37.5 mmol/L <|0.4| <|0.4| Blood

Cholesterol 13 mmol/L <|0.4| <|0.4| Blood

Citrate (sodium-) 50 mmol/L <|0.4| <|0.4| Blood

Creatine 0.2 mmol/L <|0.4| <|0.4| Blood

Cyclosporin 12 μmol/L <|0.4| <|0.4| Blood

Dobutamine 3 μmol/L <|0.4| <|0.4| Blood

(hydrochloride)

Dopamine (hydro- 5.87 μmol/L <|0.4| <|0.4| Blood

chloride)

Dobesilate 30.6 mmol/L <|0.4| <|0.4| Blood

EDTA 3.4 μmol/L <|0.4| <|0.4| Blood

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cUrea Interference on... Test matrix

Substance Test concentra- cUrea low (at 3 cUrea high (at 7

tion mmol/L) mmol/L)

Ethylurea 1 mmol/L <|0.4| <|0.4| Blood

Glucose 55 mmol/L <|0.4| <|0.4| Blood

Gluthation - 3 mmol/L <|0.4| <|0.4| Blood

reduced

HCO3 - 30 mmol/L <|0.4| 0.48 Blood

Hemoglobin 0.5 g/L N/A <|0.4| Blood

1 g/L N/A 0.49 Blood

1.5 g/L N/A 0.53 Blood

2 g/L <|0.4| 0.59 Blood

HCT 21 % <|0.4| <|0.4| Blood

75 % <|0.4| <|0.4| Blood

Hemolysis 0.13 % (0.02 g/dL <|0.4| <|0.4| Blood

hemoglobin)

0.25 % (0.04 g/dL <|0.4| <|0.4| Blood

hemoglobin)

0.38 % (0.6 g/dL <|0.4| <|0.4| Blood

hemoglobin)

0.50 % (0.8 g/dL <|0.4| 0.44 Blood

hemoglobin)

5 % (0.75 g/dL <|0.4| 0.76 Blood

hemoglobin)

10 % (1.50 g/dL <|0.4| 0.74 Blood

hemoglobin)

15 % (2.25 g/dL <|0.4| 0.64 Blood

hemoglobin)

20 % (3.00 g/dL -0.50 0.49 Blood

hemoglobin)

Heparin (sodium-) 3000 U/L <|0.4| <|0.4| Blood

Hydroxylamine 0.25 mmol/L N/A <|0.4| Blood

(hydrochloride)
0.5 mmol/L N/A 0.41 Blood

0.75 mmol/L N/A 0.61 Blood

1 mmol/L <|0.4| 0.87 Blood

Hydroxyurea 0.23 mmol/L <|0.4| <|0.4| Blood

0.46 mmol/L <|0.4| <|0.4| Blood

0.69 mmol/L <|0.4| <|0.4| Blood

0.92 mmol/L 0.51 0.42 Blood

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cUrea Interference on... Test matrix

Substance Test concentra- cUrea low (at 3 cUrea high (at 7

tion mmol/L) mmol/L)

Ibuprofen 2.425 mmol/L <|0.4| <|0.4| Blood

Intralipid 0.16 % (32 N/A <|0.4| Blood

mg/dL)

0.31 % (62 N/A <|0.4| Blood

mg/dL)

0.47 % (94 N/A <|0.4| Blood

mg/dL)

0.63 % (126 N/A 0.48 Blood

mg/dL)

1.25 % (250 N/A 0.64 Blood

mg/dL)

1.88 % (376 N/A 0.86 Blood

mg/dL)

2.5 % (500 N/A 0.81 Blood

mg/dL)

3.8 % (760 N/A 0.88 Blood

mg/dL)

5.0 % (1000 <|0.4| 0.95 Blood

mg/dL)

Iodide (sodium-) 2.99 mmol/L <|0.4| <|0.4| Blood

Lactate 6.6 mmol/L <|0.4| <|0.4| Blood

L-Dopa 0.1 mmol/L <|0.4| <|0.4| Blood

Lithium (nitrate) 3.2 mmol/L <|0.4| <|0.4| Blood

Magnesium 15 mmol/L <|0.4| <|0.4| Blood

(nitrate)

Methyl carbamate 1 mmol/L <|0.4| <|0.4| Blood

Methylurea 1 mmol/L <|0.4| <|0.4| Blood

N-acetylcysteine 10.2 mmol/L <|0.4| <|0.4| Blood

pO2 30 mmHg <|0.4| <|0.4| Blood

(Reference level: 500 mmHg <|0.4| <|0.4| Blood

80 mmHg)

Oxalate (sodium-) 1 mmol/L <|0.4| <|0.4| Blood

pCO2 15 mmHg <|0.4| -0.74 Blood

(Reference level: 20 mmHg <|0.4| -0.54 Blood

40 mmHg)
27 mmHg <|0.4| <|0.4| Blood

35 mmHg <|0.4| <|0.4| Blood

54 mmHg <|0.4| <|0.4| Blood

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cUrea Interference on... Test matrix

Substance Test concentra- cUrea low (at 3 cUrea high (at 7

tion mmol/L) mmol/L)

pCO2 69 mmHg <|0.4| <|0.4| Blood

(Reference level:
85 mmHg <|0.4| 0.52 Blood
40 mmHg)
100 mmHg <|0.4| 0.65 Blood

pH 6.85 N/A 0.52 Blood

(Reference level: 7.0 N/A 0.54 Blood

pH 7.35)
7.10 N/A 0.51 Blood

7.25 N/A <|0.4| Blood

8.0 <|0.4| <|0.4| Blood

Phenyl phosphoro- 50 μmol/L <|0.4| <|0.4| Blood

diamidate

Phenylbutazone 325 μmol/L <|0.4| <|0.4| Blood

Phosphoramidate 50 μmol/L <|0.4| <|0.4| Blood

(diethyl-)

Potassium 7 mmol/L <|0.4| <|0.4| Blood

(chloride)

Povidone-iodine 1.37 mmol/L <|0.4| <|0.4| Blood

Protein 82.5 g/L N/A <|0.4| Blood

95 g/L N/A 0.51 Blood

107.5 g/L N/A 0.60 Blood

120 g/L <|0.4| 0.71 Blood

Salicylate (salicylic 4.34 mmol/L <|0.4| <|0.4| Blood

acid)

Semicarbazid 1 mmol/L <|0.4| <|0.4| Blood

(hydrochloride)

Sodium (chloride) 180 mmol/L <|0.4| <|0.4| Blood

190 mmol/L <|0.4| <|0.4| Blood

250 mmol/L <|0.4| 0.47 Blood

310 mmol/L <|0.4| 0.63 Blood

370 mmol/L 0.42 0.77 Blood

Sodium thiosulfate 16.7 mmol/L <|0.4| <|0.4| Blood

Thiocyanate 6.88 mmol/L <|0.4| <|0.4| Blood

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cBUN Interference on... Test matrix

Substance Test concentra- cBUN 8.5 (mg/dL) cBUN 20 (mg/dL)

tion

Acetaminophen = 1.324 mmol/L <|1.1| <|1.1| Blood

paracetamol

Acetazolamide 4 μmol/L N/A -1.23 Blood

8 μmol/L N/A -1.43 Blood

13 μmol/L N/A -1.43 Blood

17 μmol/L N/A -1.34 Blood

270 μmol/L <|1.1| -1.90 Blood

Acetoacetate 10 mmol/L <|1.1| <|1.1| Blood

(lithium-)

Acetylsalicylic acid 3.62 mmol/L <|1.1| <|1.1| Blood

Ammonium 107 μmol/L <|1.1| <|1.1| Blood

Chloride

Ascorbate 342 μmol/L <|1.1| <|1.1| Blood

(sodium-)

Benzalkonium 20.75 μmol/L <|1.1| <|1.1| Blood

chloride
41.5 μmol/L <|1.1| -1.26 Blood

62.25 μmol/L -1.48 -1.82 Blood

83 μmol/L -1.96 -2.49 Blood

β-hydroxybutyrate 2.5 mmol/L N/A <|1.1| Blood

5 mmol/L N/A 1.60 Blood

7.5 mmol/L N/A 2.1 Blood

10 mmol/L <|1.1| 2.38 Blood

Bilirubin conju- 342 μmol/L <|1.1| <|1.1| Blood

gated

Bilirubin unconju- 342 μmol/L <|1.1| <|1.1| Blood

gated

Biotin 1200 ng/L <|1.1| <|1.1| Blood

Boric Acid 1 mmol/L <|1.1| <|1.1| Blood

Bromide (sodium-) 37.5 mmol/L <|1.1| <|1.1| Blood

Cholesterol 13 mmol/L <|1.1| <|1.1| Blood

Citrate (sodium-) 50 mmol/L <|1.1| <|1.1| Blood

Creatine 0.2 mmol/L <|1.1| <|1.1| Blood

Cyclosporin 12 μmol/L <|1.1| <|1.1| Blood

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cBUN Interference on... Test matrix

Substance Test concentra- cBUN 8.5 (mg/dL) cBUN 20 (mg/dL)

tion

Dobutamine 3 μmol/L <|1.1| <|1.1| Blood

(hydrochloride)

Dopamine (hydro- 5.87 μmol/L <|1.1| <|1.1| Blood

chloride)

Dopesilate 30.6 mmol/L <|1.1| <|1.1| Blood

EDTA 3.4 μmol/L <|1.1| <|1.1| Blood

Ethylurea 1 mmol/L <|1.1| <|1.1| Blood

Glucose 55 mmol/L <|1.1| <|1.1| Blood

Gluthation - 3 mmol/L <|1.1| <|1.1| Blood

reduced

HCO3 - 30 mmol/L <|1.1| 1.34 Blood

Hemoglobin 0.5 g/L N/A <|1.1| Blood

1 g/L N/A 1.37 Blood

1.5 g/L N/A 1.48 Blood

2 g/L <|1.1| 1.65 Blood

HCT 21 % <|1.1| <|1.1| Blood

75 % <|1.1| <|1.1| Blood

Hemolysis 0.13 % (0.02 g/dL <|1.1| <|1.1| Blood

hemoglobin)

0.25 % (0.04 g/dL <|1.1| <|1.1| Blood

hemoglobin)

0.38 % (0.6 g/dL <|1.1| <|1.1| Blood

hemoglobin)

0.50 % (0.8 g/dL <|1.1| 1.23 Blood

hemoglobin)

5 % (0.75 g/dL <|1.1| 2.13 Blood

hemoglobin)

10 % (1.50 g/dL <|1.1| 2.07 Blood

hemoglobin)

15 % (2.25 g/dL <|1.1| 1.79 Blood

hemoglobin)

20 % (3.00 g/dL -1.40 1.37 Blood

hemoglobin)

Heparin (sodium-) 3000 U/L <|1.1| <|1.1| Blood

Hydroxylamine 0.25 mmol/L N/A <|1.1| Blood

(hydrochloride)
0.5 mmol/L N/A 1.15 Blood

0.75 mmol/L N/A 1.71 Blood

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cBUN Interference on... Test matrix

Substance Test concentra- cBUN 8.5 (mg/dL) cBUN 20 (mg/dL)

tion

Hydroxylamine 1 mmol/L <|1.1| 2.44 Blood

(hydrochloride)

Hydroxyurea 0.23 mmol/L <|1.1| <|1.1| Blood

0.46 mmol/L <|1.1| <|1.1| Blood

0.69 mmol/L <|1.1| <|1.1| Blood

0.92 mmol/L 1.43 1.18 Blood

Ibuprofen 2.425 mmol/L <|1.1| <|1.1| Blood

Intralipid 0.16 % (31 N/A <|1.1| Blood

mg/dL)

0.31 % (63 N/A <|1.1| Blood

mg/dL)

0.47 % (94 N/A <|1.1| Blood

mg/dL)

0.63 % (125 N/A 1.34 Blood

mg/dL)

1.25 % (250 N/A 1.79 Blood

mg/dL)

1.88 % (375 N/A 2.41 Blood

mg/dL)

2.5 % (500 N/A 2.27 Blood

mg/dL)

3.8 % (750 N/A 2.49 Blood

mg/dL)

5.0 % (1000 <|1.1| 2.66 Blood

mg/dL)

Iodide (sodium-) 2.99 mmol/L <|1.1| <|1.1| Blood

Lactate 6.6 mmol/L <|1.1| <|1.1| Blood

L-Dopa 0.1 mmol/L <|1.1| <|1.1| Blood

Lithium (nitrate) 3.2 mmol/L <|1.1| <|1.1| Blood

Magnesium 15 mmol/L <|1.1| <|1.1| Blood

(nitrate)

Methyl carbamate 1 mmol/L <|1.1| <|1.1| Blood

Methylurea 1 mmol/L <|1.1| <|1.1| Blood

N-acetylcysteine 10.2 mmol/L <|1.1| <|1.1| Blood

Oxalate (sodium-) 1 mmol/L <|1.1| <|1.1| Blood

pCO2 15 mmHg <|1.1| -2.07 Blood

(Reference level: 20 mmHg <|1.1| -1.51 Blood

40 mmHg)

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cBUN Interference on... Test matrix

Substance Test concentra- cBUN 8.5 (mg/dL) cBUN 20 (mg/dL)

tion

pCO2 27 mmHg <|1.1| <|1.1| Blood

(Reference level:
35 mmHg <|1.1| <|1.1| Blood
40 mmHg)
54 mmHg <|1.1| <|1.1| Blood

69 mmHg <|1.1| <|1.1| Blood

85 mmHg <|1.1| 1.46 Blood

100 mmHg <|1.1| 1.82 Blood

pO2 30 mmHg <|1.1| <|1.1| Blood

(Reference level: 500 mmHg <|1.1| <|1.1| Blood

80 mmHg)

pH 6.85 N/A 1.46 Blood

(Reference level: 7.0 N/A 1.51 Blood

pH 7.35)
7.10 N/A 1.43 Blood

7.25 N/A <|1.1| Blood

8.0 <|1.1| <|1.1| Blood

Phenyl phosphoro- 50 μmol/L <|1.1| <|1.1| Blood

diamidate

Phenylbutazone 325 μmol/L <|1.1| <|1.1| Blood

Phosphoramidate 50 μmol/L <|1.1| <|1.1| Blood

(diethyl-)

Potassium 7 mmol/L <|1.1| <|1.1| Blood

(chloride)

Povidone-iodine 1.37 mmol/L <|1.1| <|1.1| Blood

Protein 82.5 g/L N/A <|1.1| Blood

95 g/L N/A 1.43 Blood

107.5 g/L N/A 1.68 Blood

120 g/L <|1.1| 1.99 Blood

Salicylate (salicylic 4.34 mmol/L <|1.1| <|1.1| Blood

acid)

Semicarbazid 1 mmol/L <|1.1| <|1.1| Blood

(hydrochloride)

Sodium (chloride) 180 mmol/L <|1.1| <|1.1| Blood

190 mmol/L <|1.1| <|1.1| Blood

250 mmol/L <|1.1| 1.32 Blood

310 mmol/L <|1.1| 1.76 Blood

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cBUN Interference on... Test matrix

Substance Test concentra- cBUN 8.5 (mg/dL) cBUN 20 (mg/dL)

tion

Sodium (chloride) 370 mmol/L 1.18 2.16 Blood

Sodium thiosulfate 16.7 mmol/L <|1.1| <|1.1| Blood

Thiocyanate 6.88 mmol/L <|1.1| <|1.1| Blood

N/A: Interference has not been measured on the respective parameter

Numbers in brackets, e.g. <|1|: show that the interference lies within a range of ± the
number in the brackets, i.e. <|1| = an interference within ±1.

Oximetry parameters

These interference results were found for the oximetry parameters and for ctBil:

ctHb Interference on ctHb

Substance Test levels 10 g/dL 20 g/dL

pH 6.8-8 <|0.5| <|0.5|

Fluorescein** 250 mg/L 0.7 0.6

Beta-carotene* 3.7 µmol/L <|0.5| <|0.5|

Patent Blue V 10 mg/L <|0.5| <|0.5|

Methylene Blue** 45 mg/L –0.8 –3.8

60 mg/L ND –4.9

Cardio Green 30 mg/L <|0.5| <|0.5|

Evans Blue 5 mg/L <|0.5| <|0.5|

Intralipid 5 % (1000 mg/dL) <|0.5| <|0.5|

HiCN*/** 30 % 1.3 2.4

SHb*** 10 % <|0.5| <|0.5|

Hydroxocobalamin hydro- 2 g/L 2.1 1.6

chloride**

Cyanocobalamin** 2 g/L 0.6 <|0.5|

Bilirubin (conj) 342 µmol/L <|0.5| <|0.5|

Bilirubin (unconj) 342 µmol/L <|0.5| <|0.5|

Hemolysis 20 % <|0.5| <|0.5|

Triglyceride 587 mg/dL <|0.5| <|0.5|

Rifampicin 78.1 µmol/L (64 mg/L) <|0.5| <|0.5|

Biotin 1200 ng/L <|0.5| <|0.5|

Sodium Nitroprusside 1740 µg/L <|0.5| <|0.5|

* Interference calculated from the spectrum

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** Analyzer message “OXI spectrum mismatch” is attached to the result

*** Analyzer message “SHb too high” is attached to the result

ND: Not determined

Numbers in brackets, i.e. <|1|: show that the interference lies within a range of ± the
number in the brackets, i.e. <|1| = an interference within ±1.

sO2 Interference on sO2

Substance Test levels 0% 100 %

pH 6.8-8 <|1 %| <|1 %|

Fluorescein** 250 mg/L <|1 %| –3.0

Beta-carotene* 3.7 µmol/L <|1 %| <|1 %|

Patent Blue V 10 mg/L <|1 %| <|1 %|

Methylene Blue** 60 mg/L <|1 %| 3.9

Cardio Green 30 mg/L <|1 %| 1.0

Evans Blue 5 mg/L <|1 %| <|1 %|

Intralipid 5 % (1000 mg/dL) <|1 %| <|1 %|

HiCN*/** 30 % –3.1 –14.3

SHb*** 10 % 1.6 <|1 %|

HbF 50-80 % <|1 %| <|1 %|

Hydroxocobalamin hydro- 2 g/L –3.7 –1.1

chloride**

Cyanocobalamin** 2 g/L –2.0 –2.0

Bilirubin (conj) 342 µmol/L <|1 %| <|1 %|

Bilirubin (unconj) 342 µmol/L <|1 %| <|1 %|

Hemolysis 20 % <|1 %| <|1 %|

Triglyceride 587 mg/dL <|1 %| <|1 %|

Rifampicin 78.1 µmol/L (64 mg/L) <|1 %| <|1 %|

Biotin 1200 ng/L <|1 %| <|1 %|

Sodium Nitroprusside 1740 µg/L <|1 %| <|1 %|

* Interference calculated from the spectrum

** Analyzer message “OXI spectrum mismatch” is attached to the result

*** Analyzer message “SHb too high” is attached to the result

Numbers in brackets, i.e. <|1|: show that the interference lies within a range of ± the
number in the brackets, i.e. <|1| = an interference within ±1.

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COHb Interference on COHb

Substance Test levels 0% 10 %

pH 6.8-8 <|1 %| <|1 %|

Fluorescein** 250 mg/L –4.1 –3.7

Beta-carotene* 3.7 µmol/L <|1 %| <|1 %|

Patent Blue V 10 mg/L <|1 %| <|1 %|

Methylene Blue** 60 mg/L –1.8 1.2

Cardio Green 30 mg/L <|1 %| <|1 %|

Evans Blue 5 mg/L <|1 %| <|1 %|

Intralipid 5 % (1000 mg/dL) <|1 %| <|1 %|

HiCN*/** 30 % 6.5 2.8

SHb*** 10 % <|1 %| <|1 %|

HbF 50-80 % <|1 %| ND

Hydroxocobalamin hydro- 2 g/L 2.1 <|1 %|

chloride**

Cyanocobalamin** 2 g/L 1.6 <|1 %|

Bilirubin (conj) 342 µmol/L <|1 %| <|1 %|

Bilirubin (unconj) 342 µmol/L <|1 %| <|1 %|

Hemolysis 20 % <|1 %| <|1 %|

Triglyceride 587 mg/dL <|1 %| <|1 %|

Rifampicin 78.1 µmol/L (64 mg/L) <|1 %| <|1 %|

Biotin 1200 ng/L <|1 %| <|1 %|

Sodium Nitroprusside 1740 µg/L <|1 %| <|1 %|

* Interference calculated from the spectrum

** Analyzer message “OXI spectrum mismatch” is attached to the result

*** Analyzer message “SHb too high” is attached to the result

Numbers in brackets, i.e. <|1|: show that the interference lies within a range of ± the
number in the brackets, i.e. <|1| = an interference within ±1.

ND: Not determined

MetHb Interference on MetHb

Substance Test levels 0% 10 %

pH 6.8-8 <|1 %| –1.1 %/pH

Fluorescein** 250 mg/L 10.1 9.7

Beta-carotene* 3.7 µmol/L <|1 %| <|1 %|

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MetHb Interference on MetHb

Substance Test levels 0% 10 %

Patent Blue V 10 mg/L –1.0 <|1 %|

Methylene Blue** 30 mg/L –12.0 –17.9

60 mg/L –24.0 ND

Cardio Green 30 mg/L –2.0 –1.2

Evans Blue 5 mg/L <|1 %| <|1 %|

Intralipid 5 % (1000 mg/dL) <|1 %| <|1 %|

HiCN*/** 30 % 23.9 20.6

SHb*** 10 % 1.0 –4.9

HbF 50-80 % <|1 %| ND

Hydroxocobalamin hydro- 2 g/L 14.2 12.9

chloride**

Cyanocobalamin** 2 g/L 5.7 4.7

Bilirubin (conj) 342 µmol/L <|1 %| <|1 %|

Bilirubin (unconj) 342 µmol/L <|1 %| <|1 %|

Hemolysis 20 % <|1 %| <|1 %|

Triglyceride 587 mg/dL <|1 %| <|1 %|

Rifampicin 78.1 µmol/L (64 mg/L) <|1 %| <|1 %|

Biotin 1200 ng/L <|1 %| <|1 %|

Sodium Nitroprusside 1740 µg/L <|1 %| <|1 %|

* Interference calculated from the spectrum

** Analyzer message “OXI spectrum mismatch” is attached to the result

*** Analyzer message “SHb too high” is attached to the result

Numbers in brackets, i.e. <|1|: show that the interference lies within a range of ± the
number in the brackets, i.e. <|1| = an interference within ±1.

ND: Not determined

O2Hb Interference on O2Hb

Substance Test levels 0% 100 %

pH 6.8-8 <|1 %| <|1 %|

Fluorescein** 250 mg/L <|1 %| –8.8

Beta-carotene* 3.7 µmol/L <|1 %| <|1 %|

Patent Blue V 10 mg/L <|1 %| 2.0

Methylene Blue** 60 mg/L <|1 %| 32.0

Cardio Green 30 mg/L <|1 %| 2.7

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O2Hb Interference on O2Hb

Substance Test levels 0% 100 %

Evans Blue 5 mg/L <|1 %| <|1 %|

Intralipid 5 % (1000 mg/dL) <|1 %| <|1 %|

HiCN*/** 30 % –2.1 –40.2

SHb*** 10 % 1.6 –2.1

HbF 50-80 % <|1 %| <|1 %|

Hydroxocobalamin hydro- 2 g/L –2.8 –17.2

chloride**

Cyanocobalamin** 2 g/L –1.8 –8.8

Bilirubin (conj) 342 µmol/L <|1 %| <|1 %|

Bilirubin (unconj) 342 µmol/L <|1 %| <|1 %|

Hemolysis 20 % <|1 %| <|1 %|

Triglyceride 587 mg/dL <|1 %| <|1 %|

Rifampicin 78.1 µmol/L (64 mg/L) <|1 %| <|1 %|

Biotin 1200 ng/L <|1 %| <|1 %|

Sodium Nitroprusside 1740 µg/L <|1 %| <|1 %|

* Interference calculated from the spectrum

** Analyzer message “OXI spectrum mismatch” is attached to the result

*** Analyzer message “SHb too high” is attached to the result

Numbers in brackets, i.e. <|1|: show that the interference lies within a range of ± the
number in the brackets, i.e. <|1| = an interference within ±1.

HHb Interference on HHb

Substance Test levels 0% 100 %

pH 6.8-8 <|1 %| <|1 %|

Fluorescein** 250 mg/L 2.8 2.9

Beta-carotene* 3.7 µmol/L <|1 %| <|1 %|

Patent Blue V 10 mg/L <|1 %| <|1 %|

Methylene Blue** 45 mg/L –3.3 –2.9

60 mg/L –4.4 ND

Cardio Green 30 mg/L <|1 %| <|1 %|

Evans Blue 5 mg/L <|1 %| <|1 %|

Intralipid 5 % (1000 mg/dL) <|1 %| <|1 %|

HiCN*/** 30 % 9.8 –28.3

SHb*** 10 % <|1 %| 1.2

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HHb Interference on HHb

Substance Test levels 0% 100 %

HbF 50-80 % <|1 %| <|1 %|

Hydroxocobalamin hydro- 2 g/L <|1 %| –19.8

chloride**

Cyanocobalamin** 2 g/L 1.8 –5.0

Bilirubin (conj) 342 µmol/L <|1 %| <|1 %|

Bilirubin (unconj) 342 µmol/L <|1 %| <|1 %|

Hemolysis 20 % <|1 %| <|1 %|

Triglyceride 587 mg/dL <|1 %| <|1 %|

Rifampicin 78.1 µmol/L (64 mg/L) <|1 %| <|1 %|

Biotin 1200 ng/L <|1 %| <|1 %|

Sodium Nitroprusside 1740 µg/L <|1 %| <|1 %|

* Interference calculated from the spectrum

** Analyzer message “OXI spectrum mismatch” is attached to the result

*** Analyzer message “SHb too high” is attached to the result

Numbers in brackets, i.e. <|1|: show that the interference lies within a range of ± the
number in the brackets, i.e. <|1| = an interference within ±1.

ND: Not determined

ctBil - Adult samples

ctHb ~15 g/dL. Level ctBil µmol/L

HbF correction enabled for

levels >20 %. ctBil ~0 µmol/L.

pH 6.85 <|30|

7.15 <|30|

7.4 (ref. level) N/A

8 <|30|

Fluorescein** 250 mg/L –1115

Beta-carotene* 3.7 µmol/L <|30|

Patent Blue V 10 mg/L <|30|

Methylene Blue 10 mg/L** –57

30 mg/L** –161

60 mg/L** –282

Cardio Green 7 mg/L <|30|

30 mg/L <|30|

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ctBil - Adult samples

ctHb ~15 g/dL. Level ctBil µmol/L

HbF correction enabled for

levels >20 %. ctBil ~0 µmol/L.

Evans Blue 5 mg/L <|30|

Intralipid 2 % (400 mg/dL) <|30|

5 % (1000 mg/dL) <|30|

HiCN*/** 30 % 895

SHb*** 20 % <|30|

50 % 119

Hydroxocobalamin** 2 g/L** –87

0.8 g/dL –37

0.4 g/dL <|30|

0.2 g/dL <|30|

Cyanocobalamin** 2 g/L** <|30|

0.8 g/dL** <|30|

0.4 g/dL <|30|

0.2 g/dL <|30|

Bilirubin (conj) 400 µmol/L 377

Bilirubin (unconj) 500 µmol/L 524

Hemolysis 2 % (0.3 g/dL) <|30|

5 % (0.75 g/dL) <|30|

10 % (1.5 g/dL) <|30|

20 % (3 g/dL) <|30|

Rifampicin 78.1 µmol/L (64 mg/L) <|30|

Biotin 1200 ng/L <|30|

Sodium Nitroprusside 1740 µg/L <|30|

* Interference calculated from the spectrum

** Analyzer message “OXI spectrum mismatch” is attached to the result

*** Analyzer message “SHb too high” is attached to the result if SHb >10 %. Analyzer
message “Warning: SHb detected” is attached to the result if SHb >1 %.

Numbers in brackets, i.e. <|1|: show that the interference lies within a range of ± the
number in the brackets, i.e. <|1| = an interference within ±1.

µmol/L (neonatal blood) Interference on ctBil✝

ctBil Test level(s) 85 µmol/L 260 µmol/L

pH 6.8 – 7.9 <|11| – 27 µmol/L/pH-unit

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µmol/L (neonatal blood) Interference on ctBil✝

ctBil Test level(s) 85 µmol/L 260 µmol/L

Fluorescein 40 mg/L –264 –284

Beta-carotene* 3.7 µmol/L 27 27

Patent Blue V 10 mg/L –80 –112

Methylene Blue 60 mg/L –384 –308

Cardio Green 30 mg/L –70 –93

Evans Blue 5 mg/L <|11| <|26|

Intralipid*** 5% <|11| <|26|

HiCN* 30 % 904 011

SHb*** 10 % 128 89

HbF 82 % <|11| <|26|

Hydroxocobalamin 2 g/L –271 –219

hydrochloride

Cyanocobalamin 2 g/L –154 –186

Hemolysis 20 % <|11| <|26|

Triglycerid ~500 mg/dL <|11| <|26|

Rifampicin 19.5 µmol/L <|11| <|26|

(16 mg/L)

39.1 µmol/L <|11| <|26|

(32 mg/L)

58.6 µmol/L <|11| <|26|

(48 mg/L)

78.1 µmol/L 13 <|26|

(64 mg/L )

Biotin 1200 ng/L <|11| <|26|

Sodium Nitroprusside 1740 µg/L <|11| <|26|

* Interference calculated from the spectrum

** Analyzer message “OXI spectrum mismatch” is attached to the result

*** Analyzer message “SHb too high” is attached to the result if SHb >10 %. Analyzer
message “Warning: SHb detected” is attached to the result if SHb >1 %.

**** The result is marked with the error message “Turbidity too high”

✝ Results outside reportable range will not be displayed

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HbF Interference on HbF

Substance Test levels 80 %

pH 6.8-8 40 %/pH

Fluorescein** 25 mg/L**** <|20 %|

Beta-carotene* 3.7 µmol/L <|20 %|

Patent Blue V 10 mg/L –37

Methylene Blue** 7.5 mg/L**** <|20 %|

Cardio Green 30 mg/L –30

Evans Blue 5 mg/L <|20 %|

Intralipid 5 % (1000 mg/dL) <|20 %|

HiCN* / ** 30 % HbF not reported

SHb*** 10 % HbF not reported

Hydroxocobalamin hydrochloride** 2 g/L <|20 %|

Cyanocobalamin** 2 g/L <|20 %|

Bilirubin (conj) 342 µmol/L <|20 %|

Bilirubin (unconj) 342 µmol/L <|20 %|

Hemolysis 20 % <|20 %|

Triglyceride 587 mg/dL <|20 %|

Rifampicin 78.1 µmol/L (64 mg/L) <|20 %|

Biotin 1200 ng/L <|20 %|

Sodium Nitroprusside 1740 µg/L <|20 %|

* Interference calculated from the spectrum

** Analyzer message “OXI spectrum mismatch” is attached to the result

*** Analyzer message “SHb too high” is attached to the result

**** HbF is not reported for higher levels

Numbers in brackets, i.e. <|1|: show that the interference lies within a range of ± the
number in the brackets, i.e. <|1| = an interference within ±1.

ctBil sensitivity for MCHC variations

MCHC (Mean Corpuscular Hemoglobin Concentration) is used to estimate hematocrit,

Hct, which is used in the ctBil measurement. MCHC is an average Hb concentration in
the red blood cell (RBC). If the RBC volume decreases, MCHC increases. If an RBC has
iron deficit, MCHC decreases.

Hct is determined from ctHb as follows:

Hct = ctHb/MCHC

A standard value of 332 g/L is used for MCHC which gives Hct = ctHb × 0.0301 if the
unit for ctHb is g/dL.

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MCHC can, however, deviate from this standard value as shown in the table.

Metric values that use the erythrocytes Hct and MCHC to be determined are given for
apparently healthy white and black people of different ages [23].

Group of Age Hct mean Hct 95 % range MCHC mean, g/L MCHC 95 % range,
people g/L

Men Adults 0.47 0.39-0.55 340 310-370

Women Adults 0.42 0.36-0.48 330 300-360

Boys Newborn 0.59 0.53-0.65 330 320-340

1 month 0.50 0.44-0.56 320 310-330

3 months 0.45 0.39-0.52 330 320-340

6 months 0.46 0.39-0.51 300 290-310

9 months 0.45 0.39-0.52 280 270-300

1 year 0.41 0.37-0.45 290 280-300

2 years 0.40 0.36-0.47 300 280-310

4 years 0.37 0.30-0.44 280 270-290

8 years 0.41 0.37-0.45 290 280-300

14 years 0.41 0.36-0.46 300 290-310

Girls Newborn 0.58 0.51-0.65 340 330-350

1 month 0.49 0.42-0.56 320 310-330

3 months 0.44 0.39-0.51 330 320-340

6 months 0.44 0.39-0.50 320 310-330

9 months 0.43 0.37-0.50 300 290-310

1 year 0.43 0.37-0.49 300 290-310

2 years 0.43 0.36-0.50 300 290-310

4 years 0.43 0.36-0.51 280 270-290

8 years 0.40 0.36-0.46 280 270-290

14 years 0.40 0.36-0.47 290 280-300

If ΔMCHC is defined as ΔMCHC = 332 g/L - MCHC, then the contribution to the relative
error on the ctBil measurement is as follows:

ΔctBil / ctBil = –(Hct / 1–Hct) × (ΔMCHC / MCHC)

A worst-case example, where 95 % confidence values are used:

A newborn girl with Hct = 0.58, MCHC = 350 g/L and ctBil = 400 µmol/L. ctHb may be
derived as Hct × MCHC = 0.58 × 350 g/L = 20.3 g/dL (reference range is 18.0-21.0
g/dL).

ΔctBil / ctBil = -(0.58/1 - 0.58) × (-18/350) = +0.071 and ΔctBil = 0.071 × 400 = 28
µmol/L.

If the reference value for Hct is known, it is possible to correct the shown ctBil value
with this equation:

ctBilcorrected = ctBildisplayed ×(1-ctHbdisplayed × 0.0301/1-Hctreference)

ctHb is measured in g/dL.

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ctBil is sensitive to pH deviations from the nominal value of pH = 7.4.

Traceability

Traceability to the primary standards at Radiometer

The Metrology Department at Radiometer is responsible for establishing metrological

traceability for the measured parameters [25].

pH traceability

The primary pH standards are traceable to the definitive method for pH. The definitive
method is based on a Hydrogen Electrode System. The primary pH standards are
obtained from the Danish primary laboratory for Electrochemistry (DPLEC) at the
Danish Institute of Fundamental Metrology (DFM). This primary laboratory is accredited
by Danish Accreditation (DANAK accreditation no. 255). Certification is done in accord-
ance with the method recommended by the International Union of Pure and Applied
Chemistry (IUPAC). The Hydrogen Electrode System of DLPEC is validated by compar-
ison with Standard Reference Materials (SRMs) produced by the National Institute of
Standards and Technology (NIST). The primary standards are therefore also traceable
to NIST.

The IUPAC-recommended method is described in [26].

The NIST SRMs used are: 186I/II-g, 185g, 187e, 191-I-d and 191_II-d.

Using the primary pH standards, the secondary pH standards are certified in the
Metrology Section. These are normally of the same composition as the primary buffers,
tapped into 2-mL glass ampoules and heat sterilized. The secondary buffers are stored
at 5 °C. Measurements of the secondary buffers are done using a glass electrode with
a saturated calomel reference electrode and a liquid junction of saturated KCl. The
liquid junction is a vertical, cylindrical and open liquid junction. Measurement of a
secondary buffer is done using a primary buffer together with a certified secondary
buffer as standards for making a 2-point calibration of the glass electrode arrange-
ment.

pCO2 and pO2 traceability

The primary gases used are Standard Reference Materials (SRMs) produced by NIST.
The NIST SRMs used are: 1674b and 2658a. The NIST SRM gases are used to validate
primary gravimetric working gas standards, certified by Air Products. The primary
gravimetric working gas standards are validated using a computer-controlled gas chro-
matography system, introducing the NIST SRM gases as samples and comparing the
obtained results with the certified values.

The primary gravimetric working gas standards are used as standards in the gas chro-
matography system, so that the composition of secondary working gas standards can
be determined.

By using the secondary working gas standards in a tonometer together with an

aqueous buffer solution, a solution with a known pCO2 and pO2 is produced. This
aqueous buffer solution is then used to determine the pCO2 and pO2 of secondary
working standards. These secondary working standards are aqueous buffer solutions
kept in 2-mL ampoules.

cK+ and cNa+ traceability

The primary working standards used are gravimetric standards produced from KCl and
NaCl Suprapur, produced by Merck. These primary working standards are validated

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using Standard Reference Materials (SRMs) produced by NIST, so that traceability to

NIST is achieved. The NIST SRMs used are: 919b (NaCl) and 999b (KCl). Validation of
the primary working standards is done using a flame photometer together with the
NIST SRMs.

The flame photometer method of validating the primary working standards is described
in [27].

The primary working standards are used to determine the sodium and potassium
concentrations of the secondary working standards. The concentrations of the secon-
dary working standards are measured using a flame photometer.

cCa2+ traceability

The primary standards used are the so-called Ca2+ transfer standards, produced from
NIST SRM 915b. The transfer standards are pH-stabilized to pH = 7.4, with 1 mmol/L
HEPES and an ionic strength of 160.0 mmol per kg.

The transfer standards are used to determine the calcium concentrations of secondary
standards. These measurements take place using ion-selective Ca electrodes on the
ABL735 analyzer.

cCl– traceability

The primary working standards are gravimetric standards, prepared from KCl Suprapur,
produced by Merck. The primary working standards are validated by making compara-
tive titrations using similar standards prepared from NIST SRM 999b (KCl). The titra-
tions are done using an AgNO3 solution as the titrant, and potentiometric titration
equipment.

The standardized AgNO3 solution is used as the titrant for the determination of the
chloride concentration of the secondary standards, using the potentiometric titrator
(Titrando 900 from Metrohm, Switzerland).

cGlu traceability

The primary working standards are prepared from NIST SRM 917c (D-glucose). These
primary standards are used to determine the glucose concentration of secondary
standards. The measurements take place using the glucose reference method, which is
the hexokinase/glucose-6-phosphate dehydrogenase method recommended by CLSI.
This method is described in [7].

cLac traceability

No certified standard reference material for lactate is available at present. The primary
working standards are therefore prepared from a pure commercially available material,
namely the Lithium salt of L(+) Lactic Acid (Cat. No. L-2250) supplied by the Sigma
Chemical Company.

These primary standards are used to determine the lactate concentration of secondary
standards.

The measurements take place using a spectrophotometric method. The method is

based on a reaction of lactate, catalyzed by L-Lactate Dehydrogenase (LDH). The reac-
tion produces dihydronicotinamide (NADH), which is measured at 339 nm. The method
is described in [8].

ctHb traceability

The primary standard used is an oxygenated blood sample. The ctHb value of this
sample is determined by the use of the HiCN reference method. This method is

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described in [28]. The HiCN reference method is a spectrophotometric method. The

spectrophotometer used is calibrated using a NIST SRM 930D filter. This method is
further validated using the certified reference material Hemoglobin-cyanide standard
(BCR - 522, Institute for Reference Materials and Measurements, Belgium).

The primary standard is used to calibrate the ABL735 reference instruments.

Saturation – sO2 = 100 % – traceability

The primary working standard used is a blood sample, with the ctHb value adjusted to
between 13 and 15 g/dL The blood sample is tonometered with 5.6 % CO2 – 94.4 %
O2, traceable to NIST SRM gases.

The primary standard is used to calibrate the ABL735 reference instruments.

Saturation – sO2 = 0 % – traceability

The primary working standard used is a blood sample. The blood sample is deoxygen-
ated by the use of Argon and treated with a dithionite solution.

The primary working standard is used to calibrate the ABL735 reference instruments.

FCOHb – normal value - traceability

The primary standards used are CO with atmospheric air mixtures, produced in a
container of known volume. The CO used for making these gas mixtures has a certified
purity of 99.997 %. Validation of the mixing method is done by comparison with NIST
SRM 1678 (50 ppm CO in N2).

The produced mixtures are used as calibration standards in connection with a gas chro-
matography method. The gas sample, injected into the gas chromatograph, is the gas
phase of a blood sample from a closed test tube, in which the blood sample has been
treated so that all the bound CO is released from the hemoglobin. The analyzed result
is measured in % CO, and from this the FHbCO is calculated. The method is described
in [29].

The measured blood sample is used as secondary standard and is used to calibrate the
ABL735 reference instruments.

FCOHb – 100 % - traceability

The primary working standard used is a blood sample. The blood sample is tonome-
tered with 100 % CO, with a certified purity of 99.997 % CO. The primary working
standard is used to calibrate the ABL735 reference instruments.

FMetHb traceability

The primary working standard is a blood sample. The FMetHb is determined using the
KCN addition method according to Evelyn and Malloy [10]. This method is a spectro-
photometric method, where the absorbance measurements are done at 630 nm (local
peak for MetHb) on two sets of solutions, prepared from the blood sample. The first set
allows determination of the relative MetHb content, whereas ctHb is determined from
the second set. From these measurements, the FMetHb of the blood sample can be
calculated.

FHbF traceability

The primary working standard is a blood sample. The FHbF of this sample is deter-
mined using the Cation Exchange HPLC reference method. The method is described in
[11]. The method is performed by the Hematology Laboratory at Herlev Hospital,
Denmark.

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ctBil traceability

The primary working standard is a blood sample. The total bilirubin is determined on a
serum sample prepared from this. The determination is performed using a Hitachi 717
wet-chemistry analyzer, which uses the Boehringer Mannheim reagency kit, DPD
method, given in [18]. The reference instrument is calibrated using four levels of NIST
SRM916a unconjugated bilirubin standard material.

cUrea/BUN traceability

The reference method for urea/BUN is traceable to certified reference material, NIST
SRM 912a (Urea). The method is a spectrophotometric method, based on an enzymatic
reaction.

The method is validated in relation to NIST 909c.

The method is described in [33].

cCrea traceability

The primary working standards are prepared from NIST SRM 914a (Creatinine). These
primary standards are used to determine the creatinine concentration of secondary
standards.

The measurements take place using an HPLC system. The method is based on
Reversed Phase HPLC.

The method has been validated using NIST SRM 967a (Human serum).

The method is described in [32].

References

1. CLSI Evaluation of Precision Performance of Clinical Chemistry Devices; Approved

Guidelines, EP5-A, Vol. 19, No. 2.
2. VIM93: ISO, International Vocabulary of Basic and General Terms in Metrology,
Geneva: International Organization for Standardization; 1993.
3. Kristensen HB, Salomon A, Kokholm G. International pH scales and certification of
pH.
4. Definition of pH scales, standard reference values, measurement of pH and related
terminology (Recommendations 1994). Pure and Appl Chem 1985; 57, 3: 531-42.
5. Burnett RW, Covington AK, Maas AHJ, Müller-Plathe O et al. J Clin Chem Clin
Biochem 1989; 27: 403-08.
6. IFCC reference methods and materials for measurement pH, gases and electro-
lytes in blood. Scand J Clin Lab Invest 1993; 53, Suppl 214: 84-94.
7. Glucose. CLSI/NCCLS Publication RS1-A. Clinical and Laboratory Standards Insti-
tute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, 1989.
8. Begmeyer. Methods of enzymatic analysis. 3rd ed., Verlag Chemie Deerfield Beach
1984; 6: 582-88.
9. Reference and selected procedures for the quantitative determination of hemo-
globin in blood. Approved Standard (3rd edition), CLSI/NCCLS Publication H15-2A.
Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400,
Wayne, PA 19087, 2000.
10. Evelyn K, Malloy H. Microdetermination of oxyhemoglobin, methemoglobin and
sulfhemoglobin in a single sample of blood. Biological Chem 1938; 126: 655-62.
11. Tan GB, Aw TC, Dunstan RA & Lee SH, Evaluation of high performance liquid chro-
matography for routine estimation of haemoglobins A2 and F. Journal of Clinical
Pathology 46: 852-856.
12. CLSI Method Comparison and Bias Estimation Using Patient Samples; Approved
Guideline - Second Edition, EP9-A2, Vol. 22, No. 17.

288 996-686C
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characteristics

13. Fraser CG. The application of theoretical goals based on biological variation data in
proficiency testing. Arch Pathol Lab Med 1988; 112: 402-15.
14. Ehrmeyer SS, Laessig RH, Leinweber JE, Oryall JJ. 1990 Medicare/CLIA final rules
for proficiency testing: minimum intralaboratory performance characteristics (CV
and bias) needed to pass. Clin Chem 1990; 36, 10: 1736-40.
15. Fraser CG, Petersen PH, Ricos C, Haeckel R. Proposed quality specifications for the
imprecision and inaccuracy of analytical systems for clinical chemistry. Eur J CLin
Chem Clin Biochem 1992; 30: 311-17.
16. Westgard JO, Seehafer JJ, Barry PL. Allowable imprecision for laboratory test based
on clinical and analytical test outcome criteria. Clin Chem 1994; 40, 10: 1909-14.
17. Vanderline RE, Goodwine J, Koch D, Scheer D, Steindel S, Cembrowski G. Guide-
lines for providing quality stat laboratory services. 1987 Laboratory Quality Assur-
ance Commitee.
18. Wahlefeld AW, Herz G, Bernt E. Modification of the Malloy-Evelyn method for a
simple, reliable determination of total bilirubin in serum. Scand J Clin Lab Invest
1972;29 Supplement 126: Abstract 11:12.
19. Burtis CA, Ashwood ER, Bruns DE. Tietz textbook of clinical chemistry and molec-
ular diagnostics. 5th ed. St. Louis: Saunders Elsevier, 2012.
20. Siggaard-Andersen O, Thode J, Wandrup JH. The concentration of free calcium ions
in the blood plasma ionized calcium. In: Siggaard-Andersen O, ed. Proceedings of
the IFCC expert panel on pH and blood gases held at Herlev Hospital 1980. Copen-
hagen: Radiometer Medical A/S, 1981: 163-90. Available as AS79.
21. NCCLS Interference testing in Clinical Chemistry Approved Guideline - Second
Edition, EP7-A2, 2005. Chapter 5.4 Potential Interfering Substances.
22. CLSI approved guideline for interference testing in clinical chemistry, EP7-A, Vol.
22, No. 27.
23. Giegy Scientific Tables, Physical Chemistry, Composition of Blood, Hematology,
Somametric Data, Ciba-GEIGY, 1984; 3, 207.
24. CLSI Protocols for Determination of Limits of Detection and Limits of Quantitation;
Approved Guidelines, EP17-A, Vol. 24, No. 34.
25. Kristensen H.B. Traceability to the primary reference standards at Radiometer.
Copenhagen: Radiometer Medical ApS, 2004. Code 918-541.
26. Measurement of pH. Definition, standards, and procedures. (IUPAC Recommenda-
tions 2002). Pure and Appl Chem 2002; 74, 11: 2169-2200.
27. Standardization of sodium and potassium ion selective electrode systems to the
flame photometric method. NCCLS (CLSI) Publication C29-A2. Villenova, Pa.:
NCCLS, 2000.
28. Reference methods for the quantitative determination of hemoglobin in blood
samples. NCCLS (CLSI) Publication H15-A3. Villenova, Pa.: NCCLS, 2000.
29. Collison HA, Rodkey FL, O'Neal JD. Determination of carbon monoxide in blood by
gas chromatography. Clin Chem 1968; 14, 2: 162-71.
30. Procedure for determining packed cell volume by microhematocrit method. 2nd ed.
Approved standard. NCCLS (CLSI) Publication H7-A3. Villenova, Pa.: NCCLS, 2000.
31. Spectrophotometry, using the Coupled-Enzyme Equilibrium method recommended
by AACC, measured on serum.( Clin. Chem. 26/7, 816-826 (1980)
32. High-performance liquid chromatographic determination of creatinine", Ekelund S.,
Påby P., Scand J Clin Lab Invest. 1991; 51: 67-71.
33. A Coupled-Enzyme Equilibrium Method for Measuring Urea in Serum: Optimization
and Evaluation of the AACC Study Group on Urea Candidate Reference Method.
Sampson, E.J., Baird, M.A., Burtis, C.A., Smith, E.M., Witte, D.L., Bayse, D.D. Clin.
Chem. 26, 816-826, 1980.

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290 996-686C
Derived and input parameters 11
Parameter types

Some parameters are measured by the analyzer, others are calculated from equations
that use measured / keyed-in / default values of other parameters.

Parameter type Description

Measured parameters Parameters that are measured by the analyzer

Input parameters Parameters that are keyed-in (entered) by an operator

Derived parameters Parameters that are calculated from measured, input and default values

Parameter symbols

The symbols for the parameters are based on the principles described by Wandrup [1].
Each symbol has three parts:

1 A character in italics that is an abbreviation of the property Examples:

(quantity) • p for pressure
• c for concentration
• F for fraction
• V for volume

2 An abbreviation of the parameter Examples:

• O2 for oxygen
• CO2 for carbon dioxide
• COHb for carboxyhemoglobin

3 A character that is an abbreviation of the system • B for blood

• P for plasma
• a for arterial blood
• v̄ for mixed venous blood
• A for alveolar air
• T for patient temperature

Example:

pO2(a), where p = pressure, O2 = oxygen, (a) = arterial blood.

Input parameters – definitions and acceptable values

Input parameters are parameter values that can be entered by operators, or trans-
ferred to the analyzer from an interfaced database. Only values that fall within a given
range are accepted.

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Parameter Definition Unit Input range

symbol

T Patient temperature °C 15.0-45.0

°F 59.0-113.0

N/A Temperature °C 18.0-32.0

NOTE: This is a data field in the Quality control
°F 64.4-89.6
identification screen. To get the correct QC
results, it is necessary that the ampoule tempera-
ture is entered in this field.

FO2(I) Fraction of oxygen in dry inspired air % 0-100

Fraction 0.000-1.000

ctHb Concentration of total hemoglobin in blood. g/dL 0.0-33.0

NOTE: Is used if the analyzer version does not
g/L 0-330
include the oximetry measuring system.
mmol/L 0.0-20.5

RQ Respiratory quotient, ratio between the CO2 Fraction 0.00-2.00

production and the O2 consumption

pO2(v)̄ Oxygen tension of mixed venous blood mmHg; Torr 0.0-750.0

kPa 0.00-100

sO2(v)̄ Oxygen saturation of mixed venous blood % 0.0-100.0

Fraction 0.000-1.000

Q̇t Cardiac output; volume of blood delivered from the L/min 0.0-100.0
left ventricle into the aorta per unit of time.
NOTE: Also termed CO or C.O.

V̇O2 Oxygen consumption; total amount of oxygen used mL/min 0-21000

by the whole organism per unit of time
mmol/min 0.0-937.1

VCO Volume of carbon monoxide added to the patient mL 0.0-1000.0

for measurement and calculation of V(B) [5]

FCOHb(1) The fraction of COHb measured before a CO injec- % 0.0-100.0

tion
Fraction 0.000-1.000

FCOHb(2) The fraction of COHb measured after a CO injection % 0.0-100.0

Fraction 0.000-1.000

Derived parameters

Derived parameters are calculated from equations that can include the measured
and/or input (keyed-in) values of other parameters. The accuracy of derived parame-
ters depends on the accuracy and availability of these values.

There are two types of derived parameter:

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Derived Explanation Symbols on derived

parameter parameter results
type

Calculated Necessary measured and keyed-in values are avail- Subscript c.

able
For example: x.xxxc
mmol/L

Estimated Necessary keyed-in and/or measured values are not Subscript e.

available. Default values are used.
For example: x.xxxe
mmol/L
NOTE: Default values are only used for missing
measured values, when they are clinically appro-
priate.

NOTE: Estimated oxygen status parameter values

may deviate significantly from the true values.

NOTE: When a necessary measured value is outside the range of indication, no default
value is used. No result is given for the derived parameter.

Related information
To enable the estimation of derived parameters, page 170

Default values of parameters

Parameter values that are necessary in order to calculate derived parameters are given
a default value when no other value is available.

Parameter Parameter Description Default value When is the

symbol /name type default used?

T Input Patient temperature 37.0 °C When no value is

entered
(98.6 °F)

Temperature Input Ambient temperature 25.0 °C When no value is

entered
(77 °F)
NOTE: This is a data field in the
Quality control identification
screen. To get the correct QC results,
it is necessary that the room tempera-
ture is entered in this field.

FO2(I) Input Fraction/(%) of oxygen in dry inspired 0.21 When no value is

air entered
(21.0 %)

RQ Input Respiratory quotient, ratio between 0.86 When no value is

the CO2 production and the O2 entered
consumption

ctHb Measured Concentration of total hemoglobin in 9.3087 When the param-

blood mmol/L, (15.00 eter cannot be
g/dL or 150 measured
g/L)

FCOHb Measured Fraction/(%) of carboxyhemoglobin in 0.004/ When the param-

total hemoglobin in blood eter cannot be
(0.4 %) measured

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Parameter Parameter Description Default value When is the

symbol /name type default used?

FMetHb Measured Fraction/(%) of methemoglobin in 0.004/ When the param-

total hemoglobin in blood eter cannot be
(0.4 %) measured

p50(st) Derived Partial pressure (or tension) of oxygen 3.578 kPa When the param-
at half saturation (50%) in blood (26.84 mmHg) eter cannot be
under standard conditions: derived
• T= 37 °C
• pH = 7.40
• pCO2 = 5.33 kPa
• FCOHb, FMetHb, FHbF are set to
zero

Definitions of derived parameters

Acid-base derived parameters – definitions

Symbol Definition

pH(T) pH of blood at patient temperature

cH+(T) Concentration of hydrogen ions in blood at patient temperature

pCO2(T) Partial pressure (or tension) of carbon dioxide at patient temperature

cHCO3–(P) Concentration of hydrogen carbonate in plasma (also termed actual bicar-

bonate)

cBase(B) Actual Base Excess, the concentration of titrable base when the blood is
titrated with a strong base or acid to a plasma pH of 7.40, at pCO2 of 5.33 kPa
or ABE (40 mmHg) and 37 °C, at the actual oxygen saturation [2,3,4]. Positive values
(base excess) indicate a relative deficit of noncarbonic acids; negative values
(base deficit) indicate a relative excess of noncarbonic acids.

cBase(B,ox) cBase(B) of fully oxygenated blood

cBase(Ecf) Standard Base Excess, an in vivo expression of base excess [3,4,5]. It refers
to a model of the extracellular fluid (one part of blood is diluted by two parts of
or SBE its own plasma) and is calculated using a standard value for the hemoglobin
concentration of the total extracellular fluid.

cBase(Ecf,ox) cBase(Ecf) of fully oxygenated blood

cHCO3–(P,st) Standard Bicarbonate, the concentration of hydrogen carbonate in the plasma

from blood that is equilibrated with a gas mixture with pCO2 = 5.33 kPa (40
mmHg) and pO2 ≥13.33 kPa (100 mmHg) at 37 °C [2,3]

ctCO2(P) Concentration of total carbon dioxide, (free CO2 + bound CO2) in plasma

ctCO2(B) Concentration of total carbon dioxide in blood (also termed CO2 content).
Calculated based on the total CO2 concentrations in the two phases: plasma
and erythrocyte fluid [3].

pH(st) Standard pH (or eucapnic pH), defined as the pH of plasma of blood equili-
brated to pCO2 = 5.33 kPa (40 mmHg). By ensuring the normal value of pCO2,
the respiratory influence from pH is removed, and pH(P,st) therefore reflects
the metabolic status of the blood plasma.

VCO2/V(dry air) The volume fraction of carbon dioxide in dry air

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Oximetry derived parameters – definitions

The oximetry parameters are only derived if the analyzer cannot measure them.

Parameter Definition

FHHb Fraction of deoxyhemoglobin in total hemoglobin in blood. Deoxyhemoglobin is the

part of total hemoglobin which can bind oxygen, and thus forms oxyhemoglobin. It
is also termed reduced hemoglobin, RHb.

FO2Hb Fraction of oxyhemoglobin in total hemoglobin in blood

sO2 Oxygen saturation, the ratio between the concentrations of oxyhemoglobin

(cO2Hb) and the hemoglobin (ctHb) minus the dyshemoglobins (cCOHb + cMetHb).

cO2Hb
=
ceHb

ceHb = cHHb + cO2Hb (effective hemoglobin)

Hct Hematocrit, the ratio between the volume of erythrocytes and the volume of blood

Oxygen derived parameters - definitions

Symbol Definition

pO2(T) Partial pressure (or tension) of oxygen at patient temperature

pO2(A) Partial pressure (or tension) of oxygen in alveolar air

pO2(A,T) Partial pressure (or tension) of oxygen in alveolar air at patient temperature

pO2(a)/FO2(I) Oxygen tension ratio of arterial blood and the fraction of oxygen in dry
inspired air

pO2(a,T)/ FO2(I) Oxygen tension ratio of arterial blood at patient temperature and the fraction
of oxygen in dry inspired air

p50 Partial pressure (or tension) of oxygen at half saturation (50%) in blood.
High and low values indicate decreased and increased affinity of oxygen to
hemoglobin, respectively.

p50(T) Partial pressure (or tension) of oxygen at half saturation (50%) in blood at
patient temperature

p50(st) Partial pressure (or tension) of oxygen at half saturation (50%) in blood at
standard conditions:

T = 37 °C

pH = 7.40

pCO2 = 5.33 kPa

FCOHb, FMetHb, FHbF are set to zero.

p50(st) may, however, vary due to variations in 2,3-DPG concentration or to

the presence of abnormal hemoglobins.

pO2(A-a) Difference in the partial pressure (or tension) of oxygen in alveolar air and
arterial blood.

Indicates the efficacy of the oxygenation process in the lungs.

pO2(A-a,T) Difference in the partial pressure (or tension) of oxygen in alveolar air and
arterial blood at patient temperature

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Symbol Definition

pO2(a/A) Ratio of the partial pressure (or tension) of oxygen in arterial blood and
alveolar air.

Indicates the efficacy of the oxygenation process in the lungs.

pO2(a/A,T) Ratio of the partial pressure (or tension) of oxygen in arterial blood and
alveolar air at patient temperature

pO2(x) or px Oxygen extraction tension of arterial blood.

Reflects the integrated effects of changes in the arterial pO2(a), ctO2 and p50
on the ability of arterial blood to release O2 to the tissues [6].

pO2(x,T) or px(T) Oxygen extraction tension of arterial blood at patient temperature

ctO2(B) Total oxygen concentration of blood.

Also termed O2 content.

ctO2(a-v̄) Oxygen concentration difference between arterial and mixed venous blood

BO2 Hemoglobin oxygen capacity; the maximum concentration of oxygen bound

to hemoglobin in blood saturated, so that all deoxyhemoglobin is converted
to oxyhemoglobin.

ctO2(x) Extractable oxygen concentration of arterial blood.

Defined as the amount of O2 that can be extracted per liter of arterial blood
at an oxygen tension of 5.0 kPa (38 mmHg), which maintains a constant pH
and pCO2 [6].

ḊO2 Oxygen delivery; the total amount of oxygen delivered to the whole organism
per unit of time

Q̇t Cardiac output; volume of blood delivered from the left ventricle into the
aorta per unit of time.

Also termed CO or C.O.

̇ 2
VO Oxygen consumption; total amount of oxygen utilized by the whole organism
per unit of time

FO2(I) Fraction of oxygen in dry inspired air

FShunt Relative physiological shunt or concentration-based shunt [3,6,7].

• Calculated from the pulmonary shunt equation:
·
Qs 1
=
·
ctO2 (a - v)
Qt 1+
ctO2 (A) - ctO2 (a) if both arterial and mixed venous blood
samples are used.
• May be estimated from one arterial sample by assuming a constant differ-
ence in the concentrations of total oxygen in arterial and mixed venous
blood: ctO2(a-v̄)= 2.3 mmol/L (5.15 mL/dL)

FShunt(T) FShunt at patient temperature

RI Respiratory Index; ratio between the oxygen tension difference of alveolar air
and arterial blood and the oxygen tension of arterial blood.

RI(T) Respiratory Index; ratio between the oxygen tension difference of alveolar air
and arterial blood and the oxygen tension of arterial blood at patient temper-
ature.

VO2/V(dry air) Volume fraction of oxygen in dry air

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Symbol Definition

Qx Cardiac oxygen compensation factor of arterial blood defined as the factor by

which the cardiac output should increase to allow release of 2.3 mmol/L (5.1
mL/dL) oxygen at a mixed venous pO2 of 5.0 kPa (38 mmHg) [3,6]

V(B) Volume of blood, calculated when FCOHb and V(CO) values are keyed in [3]

Electrolyte derived parameters – definitions

Parameter Definition

Anion Gap,K+ Difference between the concentration of the cations (sodium and potassium),
and the measured anions (chloride and bicarbonate)

Anion Gap Difference between the concentration of the cation (sodium), and the measured
anions (chloride and bicarbonate)

cCa2+(7.4) Concentration of calcium cations at pH = 7.40

mOsm [1/1000] × Number of moles of ions that contribute to the osmotic pressure of a
solution

Data necessary to derive electrolyte parameters

The table shows the measured parameters that are necessary to calculate the derived
electrolyte parameters.

Parameter Unit Necessary measured

parameters

Anion Gap, K+ mmol/L, meq/L cK+, cNa+, cCl-

Anion Gap mmol/L, meq/L cNa+, cCl-

cCa2+(7.4) mmol/L, meq/L, mg/dL pH, cCa2+

NOTE: pH must be between
7.2-7.6 to calculate this
parameter.

mOsm mmol/kg cNa+, cGlu

Metabolite derived parameters – definitions

Symbol Definition

GFR, if AA Glomerular filtration rate, if African American

GFR, if non AA Glomerular filtration rate, if non African Amer-

ican

GFR, if JP Glomerular filtration rate, if Japanese

GFR Schwartz Glomerular filtration rate, for patients <18

years.

GFRmdrd AA Glomerular filtration rate, modification of diet

in renal disease

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Symbol Definition

GFRmdrd nonAA Glomerular filtration rate, modification of diet

in renal disease

GFRckd AA Glomerular filtration rate, chronic kidney

disease

GFRckd nonAA Glomerular filtration rate, chronic kidney

disease

Urea:Crea or BUN:Crea Ratio of urea/BUN to creatinine

Calculation of derived parameters

Sample type

Unless otherwise stated, a derived parameter will be calculated or estimated irrespec-

tive of the sample type selected on the Patient identification screen:
• Arterial
• Capillary
• Venous
• Mixed venous
• Cord blood arterial
• Cord blood venous
• Fetal scalp
• Not specified
Some parameters, however, are defined for arterial or capillary samples only; they will
be calculated only for sample types entered as “Arterial” or “Capillary”.

The symbol for system (blood (B) or plasma (P)) is not stated in the equations unless it
is important for the calculation.

Units and symbols used in equations

All definitions and equations are based on SI units. If "T" for patient temperature is not
stated, the calculation is based on a temperature of 37.0 °C.

The following SI units are used:

Description Unit

Concentration mmol/L

Temperature °C

Pressure kPa

Fractions - (not %)

The following symbols are used in the equations:

log(x) = log10(x)

ln(x) = loge(x)

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Units of derived parameters – metabolite parameters

Symbol Unit ABL90 FLEX Input param- Sample type

PLUS analyzer eter

GFR if AA mL/min/1.73 m2 6) cCrea, age and Arterial

sex

GFR if nonAA mL/min/1.73 m2 6) cCrea, age and Arterial

sex

GFR if JP mL/min/1.73 m2 6) cCrea, age and Arterial

sex

GFR Schwartz mL/min/1.73 m2 7) cCrea, height Arterial

Urea:Crea or N/A 6) cUrea/BUN, cCrea Arterial

BUN:Crea

NOTE: 6) For patients ≥18 years [24]. 7) For patients <18 years.
NOTE: GRF Schwartz (also known as “Bedside Schwartz”): 36.2 × height in cm / cUrea
in mmol/L, BUN in mg/dL, cCrea in mmol/L.

Equations

Equations for acid-base parameters

pH(T) - equation 1

Ref. [13]:

pH(T) = pH(37) - [0.0147 + 0.0065 × (pH(37) - 7.40)][T - 37]

NOTE: The equation is different from that of previous Radiometer analyzers. The
constant 0.0146 is now changed to 0.0147, to be in accordance with NCCLS
(CLSI)-approved guidelines [8].

The change corresponds to -0.1 mpH/°C.

cH+(T) - equation 2

cH+(T) = 10(9-pH (T))

pCO2(T) - equation 3

Ref. [4]:

pCO2(T) = pCO2(37) × 10[0.019 x (T-37)]

NOTE: The equation is different from that of previous Radiometer analyzers. The
constant 0.021 is now changed to 0.019, to be in accordance with NCCLS
(CLSI)-approved guidelines [2].

The change corresponds to 2 %/5 °C.

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cHCO3–(P) - equation 4

Ref. [5]

cHCO3–(P) = 0.23 × pCO2 × 10[pH-pKp)

where pKp = 6.095

cHCO3–(P) includes ions of hydrogen carbonate, carbonate and carbamate in the

plasma.
NOTE: The equation is different from that of previous Radiometer analyzers. The pKp is
now constant, to be in accordance with NCCLS (CLSI)-approved guidelines [5].

The change corresponds to 5 % in the pH range 7-7.8.

cBase(B) - equation 5

Ref. [4]:

cBase(B) = (1 - 0.014ctHb)(cHCO3-(P) - 24.8 + (1.43 ctHb + 7.7)(pH - 7.4))

NOTE: The equation is different from that of previous Radiometer analyzers. The
calculation is done in accordance with NCCLS (CLSI)-approved guidelines [5].

However, the previous method [9] is considered a better method. The change corre-
sponds to less than 0.6 mmol/L in the reference ranges for pH, pCO2 and ctHb. The
previous range checks are retained. Outside the ±50 mmol/L range, no values are
displayed. Outside the range ±30 mmol/L, values are tagged with ?.

cBase(B,ox) - equation 6

Ref. [2]:

cBase(B,ox) = cBase(B) - 0.3062 × ctHb × (1 - sO2)

If ctHb is not measured or keyed in, the default value will be used.

If sO2 is not measured, it will be calculated from equation 39.

cBase(Ecf) - equation 7

Ref. [5]:

cBase(Ecf) = cHCO3–(P) - 24.8 + 16.2 (pH - 7.4)

See the note in equation 5.

cBase(Ecf,ox) - equation 8

cBase(Ecf,ox) = cBase(Ecf) - 0.3062 × 3 × (1 - sO2)

cHCO3–(P,st) - equation 9

Refs. [2,9]:

cHCO3–(P,st) = 24.47 + 0.919 × Z + Z x a' × (Z - 8)

Where

Equation Description

9.1 a' = 4.04 × 10-3 + 4.25 × 10-4 × ctHb

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Equation Description

9.2 Z = cBase(B) - 0.3062 × ctHb × (1 - sO2)

ctCO2(P) - equation 10

Refs. [4,5]:

ctCO2(P) = 0.23 x pCO2 + cHCO3-(P)

ctCO2(B) - equation 11

Ref. [3]:
(pH -pK ) æ ctHb ö
ctCO2 (B) = 9.286 ´ 10-3 ´ pCO2 ´ ctHb ´ é1 + 10 Ery Ery ù + ctCO2 (P ) ´ ç1 - ÷
ëê ûú è 21.0 ø

where

Equation Description

11.1 pHEry = 7.19 + 0.77 × (pH - 7.40) + 0.035 × (1 - sO2)

11.2 pKEry= 6.095 - log[1+10(pHEry - 7.84 - 0.06 × sO2)]

pH(st) - equation 12

Ref. [9]:

pH (st): see equations 5.3-5.5.

Equation Description

5.3
æ 5.33 ö æ pH(Hb) - pH ö
pH(st) = pH + log ç ÷´ç ÷
è p CO2 ø è log p CO2 (Hb) - log(7.5006 p CO )
2 ø

5.4 pH(Hb) = 4.06 × 10-2ctHb + 5.98 - 1.92 × 10(-0.16169ctHb)

5.5 log pCO2(Hb) = -1.7674 × 10-2ctHb + 3.4046 + 2.12 × 10(-0.15158ctHb)

Equations for electrolyte parameters

Anion Gap, K+ equation 43

Anion Gap, K+ = cNa+ + cK+ - cCl– - cHCO3–

Anion Gap - equation 44

Anion Gap = cNa+ – cCl– – cHCO3–

cCa2+(7.4) - equation 45

Ref. [10]:

cCa2+(7.4) = cCa2+ × 10-0.24(7.4-pH)

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Due to biological variations, this equation can only be used for a pH value in the range
7.2-7.6.

NOTE: The equation is different from that of previous Radiometer analyzers. The
previous equation was an approximation of the current equation.

The change corresponds to 1 % in the pH range 7.2-7-6.

Equations 46 and 47

See Oxyhemoglobin dissociation curve (ODC).

mOsm - equation 48

Ref. [11]

mOsm = 2cNa+ + cGlu + cUrea

Equations for oxygen parameters

pO2(T) - equation 14

Refs. [12,13]:

The standard Oxygen Dissociation Curve (ODC) is used (i.e. p50(st) = 3.578 kPa) at
actual values of pH, pCO2, FCOHb, FMetHb, FHbF (see Equations 46 and 47).

pO2(T) is calculated by a numerical method using:

ti(T) = ctHb × (1 - FCOHb - FMetHb) × sO2,i(T) + αO2(T) × pO2,i(T)

where

Equation Description See…

14.1 S = ODC(P,A,T ) Eq. 47

14.2 Eq. 46.12

S × (1 - FMetHb ) - FCOHb
sO2,i (T ) =
1 - FCOHb - FMetHb

14.3 P Eq. 46.10

pO2,i (T ) =
FCOHb
sO2,i (T ) × (1 - FCOHb - FMetHb )

14.4
é-1.15´10-2(T -37.0)+2.1´10-4 x(T -37.0)2 ù
aO2 =0.015eëê ûú

14.5 P is the variable during iteration.

14.6 ¶pH
A = ac -1.04 × × (T - 37.0 )
¶T

14.7 T = patient temperature in °C (keyed-in).

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Equation Description See…

14.8 ¶pH
= -1.47 ´ 10-2 - 6.5 ´ 10-3 ´ (pH (37 ) - 7.40)
¶T
When ti(T) = ti(37.0), then pO2,i(T) = pO2(T)

Changes in the equations for pH(T) and ctO2 correspond to less than 0.5 % of pO2(T)
in the reference range for pH, pCO2, pO2 and ctHb and T in the interval 32-42 °C,
using FHbF = 0.5 %.

pO2(A) - equation 15

Ref. [3]:

pO2(A) = FO2(I) × (p(amb) – 6.275) – pCO2 × [RQ–1 - FO2(I) × (RQ–1 – 1)]

If FO2(I) and RQ are not keyed in, they are set to the default values.

The calculation requires that the sample type is entered as “Arterial” or “Capillary”.

pO2(A,T) - equation 16

Refs. [2,3,14]:

pO2(A,T) = FO2(I) × [p(amb) – pH2O(T)] – pCO2(T) × [RQ–1 - FO2(I) × (RQ–1 – 1)]

-2 ×(T – 37.0) – 9.6 × 10-5 × (T – 37.0)2]
pH2O(T) = 6.275 × 10[2.36 ×10

If FO2(I) and RQ are not keyed in, they are set to the default values.

The calculation requires that the sample type is entered as “Arterial” or “Capillary”.

pO2(a)/FO2(I) - equation 17

pO2 (a)
pO2 (a) / FO2 (I) =
FO2 (I)
The calculation cannot be performed on the basis of the default FO2(I) value, and the
calculation requires that the sample type is entered as “Arterial” or “Capillary”.

pO2(a,T)/ FO2(I) - equation 18

pO2 (a, T )
pO2 (a, T ) / FO2 (I) =
FO2 (I)
The calculation cannot be performed on the basis of the default FO2(I) value, and the
calculation requires that the sample type is entered as “Arterial” or “Capillary”.

p50 - equation 19

Refer to equation 46.10.

The ODC is determined as described in Equations 46 and 47.

P
p50 =
FCOHb
1+
0.5 ´ (1 - FCOHb - FMetHb )

Where

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Description See...

P = ODC(S,A,T) Eq. 47

Eq. 46.11
0.5 ´ (1 - FCOHb - FMetHb ) + FCOHb
S=
1 - FMetHb

A=a

T = 37.0 °C Eq. 46.13

p50(T) - equation 20

The ODC is determined as described in Equations 46 and 47.

P
p50(T ) =
FCOHb
1+
0.5 ´ (1 - FCOHb - FMetHb )

where

Description See…

P = ODC(S,A,T) Eq. 47

Eq. 46.11
0.5 ´ (1 - FCOHb - FMetHb ) + FCOHb
S=
1 - FMetHb

¶pH
A = a - 1.04 ´ ´ (T - 37.0 )
¶T

¶pH
= -1.47 ´ 10-2 - 6.5 ´ 10-3 ´ (pH (37 ) - 7.40)
¶T

T = patient temperature in °C (keyed-in)

p50(st) - equation 21

p50 is calculated for pH = 7.40, pCO2 = 5.33 kPa, FCOHb = 0, FMetHb = 0, FHbF = 0.

The ODC is determined as described in Equations 46 and 47.

p50(st) = ODC(S,A,T)

Where

Description See…

S = 0.5 Eq. 46.11

A = a6 corresponds to pH = 7.40, pCO2 = 5.33 kPa, FCOHb = 0, FMetHb = 0, FHbF Eq. 46.13
=0

T = 37.0 °C

pO2(A-a) - equation 22

pO2(A–a) = pO2(A) – pO2(a)

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The calculation requires that the sample type is entered as “Arterial” or “Capillary”.

pO2(A-a,T) - equation 23

pO2(A-a,T) = pO2(A,T) – pO2(a,T)

The calculation requires that the sample type is entered as “Arterial” or “Capillary”.

pO2(a/A) - equation 24

pO2(a)
pO2(a/A)=
pO2(A)
The calculation requires that the sample type is entered as “Arterial” or “Capillary”.

pO2(a/A,T) - equation 25

pO2(a,T )
pO2(a/A,T )=
pO2(A,T )
The calculation requires that the sample type is entered as “Arterial” or “Capillary”.

pO2(x) or px - equation 26

Ref. [6]:

The ODC is determined as described in Equations 46 and 47.

pO2(x) is calculated by a numerical method, with the use of these equations:

Equation Description See…

26.1 S = ODC(P,A,T) Eq. 47

26.2 S ´ (1 - FMetHb ) - FCOHb Eq. 46.12

sO2,i =
1 - FCOHb - FMetHb

26.3 P Eq. 46.10

pO2,i =
FCOHb
1+
sO2,i × (1 - FCOHb - FMetHb )

26.4 ti = ctHb × (1 – FCOHb – FMetHb) × sO2,i + 0.0105 × pO2,i

26.5 A=a

26.6 T = 37 °C

When ti = ctO2 - 2.3 mmol/L, then pO2,i = pO2(x), where ctO2 is determined as
described in equation 27.

pO2(x) cannot be calculated on the basis of a default ctHb value.

pO2(x) can only be calculated if the measured sO2(a) ≤0.97.

The calculation requires that the sample type is entered as “Arterial” or “Capillary”.

pO2(x,T) - equation 50

Ref. [6,14]

The ODC is determined as described in Equations 46 and 47.

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pO2(x) is calculated by a numerical method, with the use of these equations:

Equation Description See…

50.1 S = ODC(P,A,T) Eq. 47

50.2 Eq. 46.12

S × (1 - FMetHb ) - FCOHb
sO2,i (T ) =
1 - FCOHb - FMetHb

50.3 P Eq. 46.10

pO2,i (T ) =
FCOHb
1+
sO2,i (T ) ´ (1 - FCOHb - FMetHb)

50.4 ti(T ) = ctHb × (1 - FCOHb - FMetHb) × sO2,i(T ) + αO2(T ) × pO2,i(T )

50.5 ¶pH Eq. 20

A = a - 1.04 ´ ´ (T - 37.0 )
¶T

50.6 T = patient temperature

50.7 αO2(T ) = 0.0105e [-0.115 × (T - 37) + 21 × 10-5 × (T - 37)2]

50.8 pO2,i = pO2(x,T)

when ti(T) = ctO2(37 ° C) - 2.3 mmol/L

pO2(x,T) is calculated in accordance with OSA V3.0.

pO2(x,T) can only be calculated if the measured sO2(a) ≤0.97.

pO2(x,T) is tagged with ? if any of the following parameters: sO2, FMetHb, FCOHb, pO2,
pCO2, pH or ctHb is tagged with ?.

The calculation requires that the sample type is entered as “Arterial” or “Capillary”.

ctO2 - equation 27

Ref [3]:

ctO2 = αO2 ×pO2 + sO2 × (1 - FCOHb - FMetHb) × ctHb

αO2 is the concentrational solubility coefficient for O2 in blood (here set to 0.0105
mmol/L/kPa at 37 °C [5].

ctO2 cannot be calculated on the basis of a default ctHb value.

NOTE: The equation is different from that of previous Radiometer analyzers. The
oxygen solubility coefficient is now changed from 0.00983 to 0.0105 to be in accord-
ance with NCCLS (CLSI)-approved guidelines [5].

The change corresponds to 0.00067 mmol/L/kPa.

̄ - equation 28
ctO2(a-v)

ctO2(a-v̄) = ctO2(a) - ctO2(v)̄

where ctO2(a) and ctO2(v̄) are calculated from equation 27 for arterial and mixed
venous blood, respectively. The calculation requires two measurements and input of
both pO2(v̄) and sO2(v̄).

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BO2 - equation 29

Ref. [15]:

BO2 = ctHb × (1 – FCOHb – FMetHb)

BO2 cannot be calculated on the basis of a default ctHb value.

ctO2(x) or cx - equation 30

Ref. [6]:

The ODC is determined, as described in Equations 46 and 47.

ctO2(x) = ctO2(a) – ti

where

Equation Description See…

30.1 ti = ctHb × (1 – FCOHb – FMetHb) × sO2,i + 0.0105 × pO2(5)

30.2 pO2(5) = 5.00 kPa

30.3 S = ODC(P,A,T) Eq. 47

30.4 Eq. 46.9

é FCOHb ù
P = pO2(5) ´ ê1 + ú
ëê s O2,i ´ (1 - F COHb - F MetHb)ûú

30.5 S ´ (1 - FMetHb ) - FCOHb Eq. 46.12

sO2,i =
1 - FCOHb - FMetHb

30.6 A=a

30.7 T = 37.0 °C

ctO2(a) is determined as described in equation 27.

ctO2(x) cannot be calculated on the basis of a default ctHb value.

ctO2(x) can only be calculated if the measured sO2(a) <0.97.

The calculation requires that the sample type is entered as “Arterial” or “Capillary”.

ḊO2 - equation 31

ḊO2 = ctO2 × Qṫ

Q̇t is the cardiac output and is an input parameter for the calculation of ḊO2.

If Qṫ is not keyed in, ḊO2 will not be calculated.

The calculation requires that the sample type is entered as “Arterial” or “Capillary”.

Q̇t - equation 32

·
· V O2
Qt =
ctO2 ( a - v )

If V̇O2 is not keyed in, Q̇t will not be calculated.

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V̇O2 - equation 33

V̇O2 = Q̇t × ctO2(a-v̄)

If Qṫ is not keyed in, V̇O2 will not be calculated.

FShunt - equation 34

Ref. [3]:

c tO2 (c) - c tO2 (a)

FShunt =
c tO2 (c) - c tO2 (v)

Equation Description

34.1
ctO2 (A) - ctO2 (a)
FShunt @
ctO2 (A) - ctO2 (v)

34.2
ctO2 (a) - ctO2 (v) ù
-1
é
FShunt = ê1 + ú
êë ctO2 (A) - ctO2 (a) úû
where:

ctO2(c): total oxygen in pulmonary capillary blood

ctO2(a): total oxygen in arterial blood

ctO2(A): total oxygen in alveolar air. Oxygen tension = pO2(A).

ctO2(v)̄ : total oxygen in mixed venous blood

34.3 ctO2(a) = 0.0105pO2(a) + ctHb x (1 – FCOHb – FMetHb) x sO2(a)

34.4 ctO2(A) = 0.0105pO2(A) + ctHb x (1 – FCOHb – FMetHb) x sO2(A)

34.5 ctO2(v̄) = 0.0105pO2(v̄) + ctHb × (1 - FCOHb - FMetHb) × sO2(v̄)

where:

pO2(a): oxygen tension in arterial blood; measured

pO2(A): oxygen tension in alveolar blood. See equation 15.

pO2(v̄): oxygen tension in mixed venous blood; measured and then entered

sO2(a): oxygen saturation in arterial blood; can be measured

sO2(A): oxygen saturation in (alveolar) blood calculated from equation 39 where P =

pO2(A)

sO2(v̄): oxygen saturation in mixed venous blood; measured and then entered

The calculation requires that the sample type is entered as “Arterial” or “Capillary”

If sO2(a) >0.97, the default value (3.578 kPa) will be used to estimate the ODC.

If no venous sample is measured, FShunt is estimated assuming:

ctO2(a) - ctO2(v̄) = 2.3 mmol/L in equation 34.2

FShunt(T) - equation 35

Refs. [3, 12]:

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ctO2 (a,T ) - ctO2 (v,T ) ù

-1
é
FShunt(T ) = ê1 + ú
ëê ctO2 ( A,T ) - ctO2 (a,T ) ûú

where:

ctO2(a,T): total oxygen in arterial blood at patient temperature

ctO2(A,T): total oxygen in alveolar blood at patient temperature

ctO2(v̄,T): total oxygen in mixed venous blood at patient temperature

Equation Description

35.1 ctO2(a,T) = ctO2 calculated from equation 25 for arterial pO2 and sO2 values at
37 oC

35.2 ctO2(A,T) = αO2(T) × pO2(A,T) + ctHb × (1 - FCOHb - FMetHb) × sO2(A,T)

-2 × (T - 37.0) + 2.1 × 10-4 × (T - 37.0)2]
35.3 αO2(T) = 0.0105e[ -1.15 × 10

35.4 pO2(A,T) is calculated from equation 16

35.5 sO2(A,T) = S

35.6 S = ODC(P,A,T)

See equation 47

35.7 P = pO2(A,T)

35.8 ¶pH
A = a - 1.04 ´ ´ (T - 37.0 )
¶T

35.9 T = patient temperature (keyed-in)

35.10 ¶pH
= -1.47 ´ 10-2 - 6.5 ´ 10-3 ´ (pH (37 ) - 7.40)
¶T
If sO2(a)>0.97, the default p50(st) (3.578 kPa) will be used to determine the ODC.

35.11 ctO2(v,̄ T) = ctO2(v̄) at 37 oC is calculated from equation 27 for mixed venous blood
values of pO2 and sO2.

If no mixed venous sample is measured, the FShunt(T) is estimated assuming

ctO2(a,T) - ctO2(v̄,T) = 2.3 mmol/L in equation 35.

RI - equation 36

pO2 (A) - pO2 (a)

RI =
pO2 (a)

The calculation requires that the sample type is entered as “Arterial” or “Capillary”.

RI(T) - equation 37

pO2 (A,T ) - pO2 (a,T )

RI(T ) =
pO2 (a,T )
The calculation requires that the sample type is entered as “Arterial” or “Capillary”.

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Qx - equation 38

Ref. [6]:

The ODC is determined as described in Equations 46 and 47.

2.3
Qx =
ctO2 (a) - ti

Equation Description See…

38.1 ti = ctHb × (1-FCOHb-FMetHb) × sO2,i + 0.0105pO2(5)

38.2 pO2(5) = 5.00 kPa

38.3 S = ODC(P,A,T)

38.4 Eq. 46.9

é FCOHb ù
P = pO2(5) ´ ê1 + ú
ëê s O2,i ´ (1 - F COHb - F MetHb)ûú

38.5 Eq. 46.12

S ´ (1 - FMetHb ) - FCOHb
sO2,i =
1 - FCOHb - FMetHb

38.6 A=a

38.7 T = 37.0 °C

ctO2(a) is determined as described in equation 27

Qx cannot be calculated on the basis of a default ctHb value

Qx can only be calculated if the measured sO2(a) <0.97

The calculation requires that the sample type is entered as “Arterial” or “Capillary”

V(B) - equation 42

Ref. [3]:

V ( CO )
V (B ) =
24 ´ ( FCOHb (2 ) - FCOHb (1) ) ´ 0.91 ´ ctHb

Equation Description

42.1
V (CO )
V (B ) =
21.84 ´ ( FCOHb (2 ) - FCOHb (1) ) ´ ctHb

42.2 V(CO) = volume (in mL) of carbon monoxide injected according to the procedure
and the value keyed in

42.3 FCOHb(1) = fraction of COHb measured before the CO injection

42.4 FCOHb(2) = fraction of COHb measured after the CO injection

VCO2/V(dry air) - equation 51

pCO2
VCO2 / V (dry air) =
p ( amb ) - 6.275

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VO2/V(dry air) - equation 52

pO2
VO2 / V (dry air) =
p ( amb ) - 6.275

Equations for oximetry parameters

FHHb - equation 41

FHHb = 1 - sO2 x (1 - FCOHb - FMetHb) - FCOHb - FMetHb

If sO2 is not measured, it will be calculated from equation 39.

If dyshemoglobins (FCOHb, FMetHb) are not known, they are set to the default values.

FO2Hb - equation 40

FO2Hb = sO2 x (1 - FCOHb - FMetHb)

If sO2 is not measured, it will be calculated from equation 39.

If dyshemoglobins (FCOHb, FMetHb) are not known, they are set to the default values.

sO2 - equation 39

The ODC is determined as described in Equations 46 and 47 (points I and III).

S ´ (1 - FMetHb ) - FCOHb
sO2 =
1 - FCOHb - FMetHb

Where

Description See…

S = ODC(P,A,T)

pO2 ´ FCOHb Eq. 46.9

P = pO2 +
sO2 ´ (1 - FCOHb - FMetHb )

A=a

T = 37.0 °C

Hct - equation 13

Ref. [15]:

Hct = 0.04939 × ctHb

Hct cannot be calculated on the basis of a default ctHb value.

NOTE: The equation is different from that of previous Radiometer analyzers. The
previous equation Hct = 0.0485 × ctHb + 8.3 × 10-3 was changed to ensure that
Hct = 0 when ctHb = 0. The slope was adjusted to make Hct identical for the two
equations when ctHb = 9.3087 mmol/L.

The change corresponds to 1 % in the ctHb range 6.3-12.3.

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FHbF - equation 49

An iterative method is used to calculate FHbF. The input parameters are sO2, ceHb
(effective hemoglobin concentration) and cO2HbF (concentration of fetal oxyhemo-
globin).

In the calculations the following are assumed: pH = 7.4, pCO2 = 5.33 kPa, FCOHb = 0,
FMetHb = 0, cDPG = 5 mmol/L, and temp = 37 °C.

Equation Description See…

49.1 An estimate of FHbF is made: FHbFest = 0.8

49.2 pO2,est = ODC (sO2,A,T); Eq. 47

where the constant A depends on FHbF = FHbFest

49.3 sO2 (for fetal blood) = ODC (pO2,est A,T); Eq. 47

where FHbF = 1

49.4 cO2HbFest = sO2 (fetal blood) × ceHb ×FHbFest

49.5 cO2HbFmeas. - cO2HbFest

DFHbFest =
ceHb

49.6 If |ΔFHbFest| ≥ 0.001, proceed to equation 49.7.

If |ΔFHbFest| < 0.001, proceed to equation 49.9.

49.7 FHbFest,new = FHbFest,old + ΔFHbFest

49.8 Return to equation 49.2.

49.9 End of iteration. The value for FHbF has converged.

Related information
Calculation of the values of the oximetry parameters, page 353

Equations for metabolite parameters

GFR if AA - equation 53

GFR (mL/min/1.73 m2) = 175 × (Scr/88.4) − 1.154 × (Age) − 0.203 × (0.742 if female) ×
1.210

GFR if non AA - equation 54

GFR (mL/min/1.73 m2) = 175 × (Scr/88.4) − 1.154 × (Age) − 0.203 × (0.742 if

female)

GFR if JP - equation 55

GFR if JP: 194 × (Scr/88.4) −1.094 × Age −0.287 × (0.739 if female)

GFR Schwartz - equation 56

GRF Schwartz (also known as “Bedside Schwartz”): 36.2 × height in cm / Creatinine in

μmol/L.

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GFRmdrd AA - equation 57

GFR (mL/min/1.73 m2) = 175 × (Scr/88.4)−1.154 × (Age)−0.203 × (0.742 if female) ×

1.210

This parameter provides the same function and information as GFR if AA, which was
introduced with an earlier software version.

GFRmdrd nonAA - equation 58

GFR (mL/min/1.73 m2) = 175 × (Scr/88.4)−1.154 × (Age)−0.203 × (0.742 if female)

This parameter provides the same function and information as GFR if nonAA, which
was introduced with an earlier software version.

GFRckd AA - equation 59

Ref. [18]:

GFR = 141 × min(Scr/k,1)α × max(Scr/k,1)−1.209 × 0.993Age × 1.018 (if female) ×

1.159

NOTE: k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for
males.

GFRckd nonAA - equation 60

Ref. [18]:

GFR = 141 × min(Scr/k,1)α × max(Scr/k,1)−1.209 × 0.993Age × 1.018 (if female)

NOTE: k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for
males.

Urea/BUN-to-creatinine ratio - equation 61

Urea [mmol/L]/Creatinine [mmol/L]

BUN [mg/dL]/Creatinine [mg/dL]

Converting results to other units

You can use the equations in the table to convert results to other units.

Parameter Unit Equation to convert

Temperature (T) T ºF = 9/5 (T ºC) + 32

T ºC = 5/9 (T ºF – 32)

cK+, cNa+, cCl– cX (meq/L) = cX (mmol/L) where X is K+, Na+ or Cl–

cCa2+ cCa2+ (meq/L) = 2 x cCa2+ (mmol/L)

cCa2+ (mg/dL) = 4.008 × cCa2+ (mmol/L)

cCa2+ (mmol/L) = 0.5 x cCa2+ (meq/L)

cCa2+ (mmol/L) = cCa2+(mg/dL) / 4.008

Pressure p (mmHg) = p (Torr) = 7.500638 x p (kPa)

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Parameter Unit Equation to convert

Pressure p (kPa) = 0.133322 × p (mmHg) = 0.133322 x p (Torr)

ctHb* ctHb (g/dL) = 1.61140 × ctHb (mmol/L)

ctHb (g/L) = 16.1140 × ctHb (mmol/L)

ctHb (mmol/L) = 0.62058 × ctHb (g/dL)

ctHb (mmol/L) = 0.062058 × ctHb (g/L)

ctCO2, ctO2, ctO2(a-v̄), BO2 Vol % = 2.241 × (mmol/L)

Vol % = mL/dL

mmol/L = 0.4462 × (mL/dL)

V̇O2 V̇O2 mmol/min = V̇O /22.41 mL/min

2

cGlu*** cGlu (mg/dL) = 18.016 × cGlu (mmol/L)

cGlu (mmol/L) c Glu (mg/dL) / 18.016

cLac**/*** cLac (mg/dL) = 9.008 × cLac (mmol/L)

cLac (mmol/L) = c Lac (mg/dL) / 9.008

cLac (meq/L) = cLac (mmol/L)

ctBil ctBil (µmol/L) = 17.1 × ctBil (mg/dL)

ctBil (µmol/L) = 1.71 × ctBil (mg/L)

ctBil (mg/dL) = (1/17.1) × ctBil (µmol/L)

ctBil (mg/L) = (1/1.71) × ctBil (µmol/L)

cCrea cCrea (mg/dL) = 0.011312 cCrea (µmol/L)

BUN BUN (mg/dL) = cUrea (mmol/L)/0.357

Urea cUrea (mg/dL) = cUrea (mmol/L) × 6.006

* See [2].

** cLac conversion is based on the molecular weight of lactic acid.

*** See [16].

Oxyhemoglobin dissociation curve

ODC equations

These equations account for the effect of FCOHb on the shape of the Oxyhemoglobin
Dissociation Curve (ODC) in accordance with the Haldane equation.

Equation 46 - Ref. [12,14]:

y - y0 = (x - x0) + h × tanh[k0(x - x0)]

where k0 = 0.5343

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Equation Description

46.1 x = ln p

46.2 s
y = ln
1- s

46.3 so
yo = ln
1 - so
where s0 = 0.867

46.4 x0 = x00 + a + b = ln(p00) + a + b

where p00 = 7 kPa.

The actual position of the ODC in the coordinate system (ln(s/(1-s)) vs ln(p)) used in
the mathematical model, is expressed by equations 46.3 and 46.4.

The symbols a and b reflect the ODC displacement from the reference position to its
actual position in this coordinate system:

a describes the displacement at 37 °C.

b the additional displacement due to the patient temperature difference from 37 °C.

The ODC reference position

The reference position of the ODC was chosen to be the one that corresponds to the
default value for p50(st) = 3.578 kPa, which is traditionally considered the most likely
value of p50 for adult humans under standard conditions, namely:

pH = 7.40; pCO2 = 5.33 kPa; FCOHb, FMetHb, FHbF = 0; cDPG = 5 mmol/L.

The ODC displacement

The ODC displacement which is described by a and b in the coordinate system

(ln(s/(1-s)) vs ln(p)), is given by the change in p50 from the default to its actual value
in a more common coordinate system (sO2, pO2).

Equation Description

46.5 p
x - xo = ln -a-b
7

46.6 h = h0 + a, where h0 = 3.5

46.7 b = 0.055 × (T - To)

T o = 37 °C

46.8 p = pO2 + M × pCO where M × pCO is taken from the Haldane equation [17]:

pO2 pCO
=M´
cO2Hb cCOHb to give equation 46.9

46.9 pO2 é FCOHb ù

p = pO2 + ´
sO2 êë1 - FCOHb - FMetHb úû or equation 46.10

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Equation Description

46.10 p
pO2 =
FCOHb
1+
sO2 ´ (1 - FCOHb - FMetHb )

s The ordinate, s, may loosely be termed the combined

oxygen/carbon monoxide saturation of hemoglobin and is
described by equation 46.11.
1
~a 1 = Reference position

2= Actual position
2

46.11 cO2Hb + cCOHb

s=
cO2Hb + cCOHb + cHHb
sO2 ´ (1 - FCOHb - FMetHb ) + FCOHb
s=
or 1 - FMetHb

46.12
s ´ (1 - FMetHb ) - FCOHb
sO2 =
1 - FCOHb - FMetHb

The actual ODC position

The actual position of the ODC at 37 °C for a given sample is, in principle, determined
in two steps:
1. The calculation of the combined effect on the ODC position at 37 °C of all known
causes for displacement (= ac in equation 46.13), and based on this position.
2. The computation by a numerical method of the actual position of the ODC curve by
shifting it to pass through the known set of coordinates (P0, S0).

Equation Description

46.13 a = ac + a6

46.14 ac = a1 + a2 + a3 + a4 + a5

46.15 a1 = -0.88 × (pH - 7.40)

46.16 pCO2
a2 = 0.048 ´ ln
5.33

46.17 a3 = -0.7 × FMetHb

46.18 a4 = (0.06 - 0.02FHbF) × (cDPG - 5)

46.19 a5 = -0.25 × FHbF

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To determine the actual displacement

1. pO2, sO2 can be used. If sO 2>0.97, the calculation is based on the calculation in
steps 2 or 3.

s ~ ac

1
✳(P01 S0)

1 = Reference position
Coordinates (P0, S0) are calculated from equations 46.9 and 46.11. If FCOHb and
FMetHb are not known, the default values are used.
The ODC is shifted from the reference position to a position that corresponds to
the effect of all measured parameters according to step 1. The magnitude of the
shift is ac. The ODC is then further shifted to pass through the point P0, S0). The
magnitude of the shift is a6.

s ~ ac

1 ~ a6
✳(P01 S0)

1 = Reference position

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2. sO2>0.97 (or erroneous) and p50(st) is known. Coordinates (P0, S0) are calculated
from (p50(st), 0.5) with the use of equations 46.9 and 46.11. Reference position
of the ODC.

1 = Reference position
The ODC is shifted from the reference position to pass through the point (P0, S0).
In this position, the ODC reflects the p50(st) of the patient, i.e., the particular
patient but at standard conditions.

1
✳(P01 S0)

1 = Reference position
The ODC is further shifted, as determined by the effect of the measured parame-
ters (ac), to its actual position. This position reflects the p50(act) of the patient.

1 ~ a6
✳ (P01 S0)

1 = Reference position

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3. sO2> 0.97 (or erroneous). Reference position of the ODC.

The position of the actual ODC can now be approximated from the reference posi-
tion, using the actual values of pH, pCO2, FCOHb, FMetHb and FHbF to determine
the shift ac.

1
~ ac

1 = Reference position
NOTE: The curves are used only to illustrate the principles of the ODC determina-
tion.

Coordinates on the ODC

Calculation of a set of coordinates on the ODC is symbolized by:

Equation 47:

S = ODC(P,A,T) or P = ODC(S,A,T)

These equations are symbolic representations of the relationship between saturation

(S), tension (P), displacement (A) and temperature (T).

To calculate S or P and to further calculate sO2 and pO2, the other variables should be
specified. S and P are calculated using numerical methods.

P is input to equation 46.1.

S is input to equation 46.2.

A is input to equation 46.5.

T is input to equation 46.7.

References

1. Wandrup JH. Physicochemical logic and simple symbol terminology of oxygen

status. Blood Gas News 1993; 2,1: 9-11.
2. Siggaard-Andersen O. The acid-base status of the blood. 4th revised ed. Copen-
hagen: Munksgaard, 1976.
3. Siggaard-Andersen O, Wimberley PD, Fogh-Andersen N, Gøthgen IH. Measured
and derived quantities with modern pH and blood gas equipment: calculation algo-
rithms with 54 equations. Scand J Clin Lab Invest 1988; 48, Suppl 189: 7-15.
4. Burnett RW, Noonan DC. Calculations and correction factors used in determination
of blood pH and blood gases. Clin Chem 1974; 20,12: 1499-1506.

996-686C 319
Chapter 11: Derived and input ABL90 FLEX PLUS: Instructions for use
parameters

5. Blood gas and pH analysis and related measurements; approved guideline. NCCLS
(CLSI) document C46-A2, Vol. 29 No. 8, 2009.
6. Siggaard-Andersen O, Gøthgen IH, Wimberley PD, Fogh-Andersen N. The oxygen
status of the arterial blood revised: relevant oxygen parameters for monitoring the
arterial oxygen availability. Scand J Clin Lab Invest 1990; 50, Suppl 203: 17-28.
Available as AS108.
7. Wandrup JH. Oxygen uptake in the lungs. Blood Gas News 1992; 1,1: 3-5.
8. Severinghaus JW. Blood gas calculator. J Appl Physiol 1966; 21,3: 1108-16. Avail-
able as ST36.
9. Christiansen TF. An algorithm for calculating the concentration of the base excess
of blood. In: Siggaard-Andersen O, ed. Proceedings of the IFCC expert panel on pH
and blood gases held at Herlev Hospital 1980. Copenhagen: Radiometer Medical
A/S, 1981: 77-81.
10. Siggaard-Andersen O, Thode J, Wandrup JH. The concentration of free calcium ions
in the blood plasma ionized calcium. In: Siggaard-Andersen O, ed. Proceedings of
the IFCC expert panel on pH and blood gases held at Herlev Hospital 1980. Copen-
hagen: Radiometer Medical A/S, 1981: 163-90. Available as AS79.
11. Burton DR. Clinical physiology of acid-base and electrolyte disorders. 4th ed. New
York: McGraw-Hill, 1994.
12. Siggaard-Andersen O, Wimberley PD, Gøthgen IH, Siggaard-Andersen M. A mathe-
matical model of the hemoglobin-oxygen dissociation curve of human blood and of
the oxygen partial pressure as a function of temperature. Clin Chem 1984; 30:
1646-51.
13. Siggaard-Andersen O, Wimberley PD, Gøthgen IH, Fogh-Andersen N, Rasmussen
JP. Variability of the temperature coefficients for pH, pCO2 and pO2 in blood.
Scand J Clin Lab Invest 1988; 48, Suppl 189: 85-88.
14. Siggaard-Andersen O, Siggaard-Andersen M. The oxygen status algorithm: a
computer program for calculating and displaying pH and blood gas data. Scand J
Clin Lab Invest 1990; 50, Suppl 203: 29-45.
15. Kokholm G. Simultaneous measurements of blood pH, pCO2, pO2 and concentra-
tions of hemoglobin and its derivatives - a multicenter study. Scand J Clin Lab
Invest 1990; 50, Suppl 203: 75-86. Available as AS107.
16. Olesen H et al. A proposal for an IUPAC/IFCC recommendation, quantities and
units in clinical laboratory sciences. IUPAC/IFCC Stage 1, Draft 1, 1990: 1-361.
17. Roughton FJW, Darling RC. The effect of carbon monoxide on the oxyhemoglobin
dissociation curve. Am J Physiol 1944; 141: 17-31.
18. Levey, Andrew S, Stevens, Lesley A, Scvhmid, Christopher H, Zhang, Yapin (Lucy),
Castro III, Alejandro F, Feldman, Harold I, Coresh, Josef. A new equation to
esimate glomerular filtration rate. NIH Public Access Author Manuscript Ann Intern
Med. Author manuscript; available in PMC 2009 October 19.

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Principles of operation 12
General construction

Sensors

In this manual, the term sensor refers to an individual sensor as part of the sensing
array within a Sensor Cassette. The electrical signal from each sensor is measured by
proprietary analog electronics contained within the analyzer unit.

The sensors are located on sensor boards in the Sensor Cassette.

Ref Urea/ K Na P CO2 pH Cl Ca P O2

BUN

Lac Glu Crea Crea

3-enz. 2-enz.

NOTE: Creatinine and urea/BUN are featured on the SC90 Ki sensor cassettes only.

General measurement principles

Introduction

There are four different measuring principles employed in the sensors in the ABL90
FLEX PLUS analyzer.

• Potentiometry: The potential of an electrode chain is measured by a voltmeter,

and related to the concentration of the sample (the Nernst equation). The potentio-
metric measuring principle is applied in the pH, pCO2, K+, Na+, Ca2+, urea/BUN and
Cl- sensors.
• Amperometry: The magnitude of an electrical current that flows through an elec-
trode chain is proportional to the concentration of the substance that is oxidized or
reduced at a electrode in the chain. The amperometric measuring principle is
applied in the cGlu, cLac and creatinine sensors.
• Optical pO2: The optical system for pO2 is based on the ability of O2 to reduce the
intensity and time constant of the phosphorescence from a phosphorescent dye that
is in contact with the sample. This measuring principle is applied in the pO2 sensor.
• Spectrophotometry: Light passes through a cuvette that contains a hemolyzed
blood sample. The absorption spectrum is used to calculate oximetry parameters.
This measuring principle is used for ctHb, sO2, FO2Hb, FCOHb, FHHb, FMetHb, FHbF
and ctBil.
NOTE: Creatinine and urea/BUN are featured on the SC90 Ki sensor cassettes only.

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Activity vs. concentration

Strictly speaking, in potentiometry the potential of an electrode chain is related to the

activity of a substance not its concentration.

The activity of a substance can be considered the effective concentration of a species

that takes non-ideality of the medium into account.

Activity and concentration are related by this equation:

ax = ɣcx

where:

ax = the activity of the species x

ɣ = the activity coefficient of species x under the measurement conditions (for ideal
systems ɣ = 1)

cx = the concentration of species x (mol/L)

NOTE: To be exact, activity is related to the molality of species x (the amount of

substance of the solute (in mol), divided by the mass of the solvent (in kg)). However,
molality is converted to concentration (molarity).

The analyzer automatically converts activities into concentrations. The term concentra-
tion is therefore used in explanations of the measuring principles for each of the
sensors.

Fluid transport system

Patient samples and solutions necessary for calibration, QC measurements and other
procedures are transported through the fluid transport system of the analyzer. The
diagram shows the fluid transport system. The sample is aspirated from the inlet,
transported through the Sensor Cassette and the oximetry module and into the waste
pouch of the Solution Pack.

After a patient sample analysis the system is rinsed. The CAL 1 solution from the Solu-
tion Pack is used.

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1 Liquid sensor 3 15 Flow selector (to select a solu-

tion/gas)

2 Hemolyzer 16 Closed position (nothing selected)

3 Oximetry valve 17 Position to select air

4 Liquid sensor 2 18 ◦ Pouch not in use (SP90)

◦ Pouch with Cal 4 (SP90 Ki)

5 Reference electrode 19 Pouch to hold waste

6 Sensor Cassette 20 Pouch with CAL 3 solution

7 Optical pO2 sensor 21 Pouch to hold clot waste

8 Liquid sensor 1 22 Pouch with CAL 1 solution

9 Sample inlet (position for capillary 23 Pouch with gas mixture

tubes)

10 Sample inlet (position for syringes 24 Pouch with QC 1 solution

and test tubes)

11 Peristaltic pump 25 Pouch with CAL 2 solution

12 Waste valve 26 Pouch with QC 3 solution

13 Smart chip 27 Pouch with QC 2 solution

14 Solution Pack 28 Electrical shield

Measurement process

The measurement process is similar for all types of measurement, patient sample anal-
ysis, built-in QC measurements, ampoule-based QC measurements, calibration-verifi-
cation measurements and calibration measurements.

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1. The sample (patient sample, QC solution or calibration solution) is aspirated or

drawn into the sensor measurement chamber and the oximetry measurement
chamber.
2. Measurements are done as soon as the sample is in the chambers. Liquid sensors
control the process and can detect sample inhomogeneity and air bubbles in the
sample. If any problems are found or the sample volume is too low, the measure-
ment is aborted and the problem reported in a message attached to the result.
3. A rinse is done.
4. A status calibration is done for all parameters.

Rinse process

A rinse is done after a measurement is completed.

1. The sample is removed.

2. The system is rinsed with a mixture of solution and air/gas.
3. The system is filled with CAL1 to prepare for next sample.
During the rinse procedure, a check of the fluid transport system is done.

Calibration

Definition

Calibration is the process that relates the sensor signals during the calibration
sequence to the values of the calibrating solutions and air. Calibration enables the
sensor signals to be converted to the accurate values for an unknown sample.

Frequency

Automatic calibrations are scheduled by default to be done at regular intervals. This is

necessary to compensate for small changes in the behavior of the sensors in the
Sensor Cassette.

Calibration solutions

CAL 1, CAL 2 and CAL 3 solutions are used for the calibration of sensors. CAL 4 solu-
tion is used for the calibration of sensors with the configuration featuring creatinine
and urea/BUN*. Air is used for the calibration of the pO2 sensor.

The calibration solutions contain known concentrations of the parameters to be meas-

ured. These concentrations are necessary to determine the measurement results. The
concentrations are automatically read from a chip on the Solution Pack when the Solu-
tion Pack is installed.

* SP90 Ki only

The calibration equation

About the calibration equation

The calibration equation expresses the relationship between the electrical measure-
ment at a sensor and the concentration of the parameter specific to the sensor.

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Plotting a calibration line

The calibration equation for each sensor is established during sensor calibration.

For the pH sensor, the relationship between potential and pH is linear. Thus, this type
of sensor can be calibrated from the measurement of two solutions of known concen-
tration. The measured potentials are plotted against the known concentrations and a
line is drawn between them.

The calibration of the pH sensor shows how this equation is established.

• Solution 1 (s1), which has a pH of 7.40, gives a measured potential of 2.3 mV.
• Solution 2 (s2), which has a pH of 7.03, gives a measured potential of 20.4 mV.

These points are plotted on a graph and a line is drawn between them.

mV

20.4

2.3

pH
7.03 7.40
s2 s1

The calibration line is used to convert the potential measured at the pH sensor during
sample analysis to an actual pH value.

For electrolyte sensors, ion concentrations are plotted on a log scale (log10(aion)).

Sensitivity, status and drift

Sensitivity

The sensitivity value shown in calibration results shows how much the sensitivity of a
sensor differs from the sensitivity of a theoretical sensor.

The sensitivity of a theoretical sensor is 100 %. If a sensor sensitivity is reported to be

95 %, its sensitivity is 5 % less than the theoretical sensor sensitivity.

The sensitivity of a sensor is the slope of its calibration line.

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mV

96

65.25 2

pH
6.8 7.3

1 Calibration line for the sensor 2 Calibration line for a theoretical

sensor
Slope = –58.4 mV/pH
Slope= –61.5 mV/pH
Sensitivity = 95 %
Sensitivity = 100 %

The sensitivity of a sensor is calculated as:

Potential at 6.8 - Potential at 7.3

Sensitivity = (%)
61.5 ´ (7.3 - 6.8 )

Where 61.5 = sensitivity of theoretical sensor.

Each sensor has its own sensitivity limits.

The sensitivities are range-checked:

pH pCO2 pO2 cK+ cNa+ cCa2+ cCl– cGlu cLac cCrea

% % % % % % % pA/m pA/m pA/ µM

mol/L mol/L

Min. 85 60 85 85 85 85 75 100 100 100

Max. 105 105 110 105 105 105 105 2000 2000 2000

cCrea

5 pA/µM <= sCr2 <= 35 pA/µM

5 pA/µM <= sCrn3 <= 30 pA/µM

5 pA/µM <= sCr3 <= 35 pA/µM

The calibration line slope is re-established with every calibration.

A blood sample gives a measured potential of 4.8 mV at the pH sensor. This potential
corresponds to a pH of 7.35 (see the diagram).

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mV

20.4

4.8
2.3

pH
7.03 7.35 7.40
s2 s1

To compensate for deviations from ideal conditions (for example, residual rinse solution
that dilutes a sample), a correction is applied to measurement results. Applied correc-
tions are usually linear corrections.

Status

The calibration status values are, in general, defined as the sensor signals of CAL 1
except for pO2, which is only calibrated in one point (pO2 status reflects the cal check).

Drift

Drift describes the variation in location of the calibration line between consecutive cali-
brations. A Status calibration is done with every measurement. This lets the analyzer
automatically compensate for status drifts. Sensitivity drift is usually insignificant in
comparison with status drift.

Reference electrode

Background information - reference electrode

Purpose

The purpose of the reference electrode is to provide a stable, fixed potential, against
which the potential differences can be measured.

The potential of the reference electrode is not changed by the sample composition.

Fixed potential

A fixed potential is maintained at the reference electrode by these equilibrium reac-

tions:

AgCl Û Ag+ + Cl-

Ag+ + e- Û Ag

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These reactions are possible because the electrode is made of an Ag rod coated with
AgCl to provide the Ag/Ag+ equlibrium in a solution with constant Cl- concentration and
thus determining the reference potential.

Use

The reference electrode is used in the measurement of pH and electrolyte concentra-

tions. Contact with the sample is made via a membrane junction between the refer-
ence electrode liquid chamber and the measuring chamber.

Construction - reference electrode

Construction

3
5
2

1 Membrane – Interface to the 4 Electrical contact – The point of

sample electrical contact between the elec-
trode and the analyzer

2 Electrolyte solution – Acts as a 5 Housing – Sensor Cassette housing

salt-bridge solution that maintains with integrated reference electrode
an electrical contact between the
electrode and the sample

3 Electrode – Provides the contact

between the electrolyte solution
and the electrical contact

pH and electrolyte sensors

Construction - pH and electrolyte sensors

Construction

The pH and electrolyte sensors are of solid-state design with a H+, K+, Na+ and Ca2+
sensitive PVC membrane. The Cl– sensor is of solid-state design with a Cl– sensitive
epoxy membrane.

The pH sensor is used as an example:

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1
2

3
4

1 Membrane – Ion-selective 3 Electrical contact – The point of

membrane that is in direct contact electrical contact between the
with the sample or calibration solu- sensor and the analyzer
tion and that is sensitive to a
specific ion, e.g. the H+ ions

2 Solid-state contact – The point of 4 Sensor base – The structural plat-

electrical and ionic contact with the form on which the sensor is formed
membrane

Measurement principles - pH and electrolyte sensors

Potentiometric measurement principle

The pH and electrolyte sensors are measured according to the potentiometric measure-
ment principle, where the potential of an electrode chain recorded at a voltmeter is
related to the concentration of a substance via the Nernst equation.

Electrode chain

The electrode chain (or electrical circuit) set up to measure pH/electrolytes is shown in
this diagram:

1
V

2 3 4 5 6

1 Voltmeter – measures the potential 4 Sample – the unknown liquid that

in the circuit. is measured.

2 Reference electrode – provides 5 Membrane – an ion-sensitive

electrical connection to the volt- membrane, which is sensitive to
meter. H+/electrolyte ions.

3 Liquid junction – point of contact 6 Solid-state contact – provides elec-

between the reference electrode trical connection to the voltmeter.
and the sample.

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Electrode chain potential

Every element in the electrode chain contributes a voltage to the total potential drop
through the chain.

The total potential across the electrode chain, therefore, is the sum of these separate
potentials, all but one of which are known and constant, as outlined in the table:

Element Potential Symbol

Reference electrode Known and constant when the Ag/AgCl is Eref

immersed in the electrolyte solution

Liquid junction between the electrolyte Known and constant. Independent of ELJ
solution in the reference electrode and the sample composition .
sample

Ion-sensitive membrane that separates Unknown. Dependent on sample composi- ESample

the sample and the pH sensor tion.

Solid-state contact Known and constant EE

Total potential Measured by the voltmeter Etot

Derived potential

The unknown potential difference across the ion-sensitive PVC membrane is the differ-
ence between the measured total potential and the sum of the known potentials:

Esample = Etotal - (Eref + ELJ + EE)

Ion-sensitive membrane

The potential difference across the membrane arises as a consequence of a change in

the charge balance at the membrane.

The membrane is sensitive to H+/electrolyte ions in that it has an ion-exchange ability.

The internal solid-state reference electrode maintains the internal potential at the same
level. Changes in the H+/electrolyte ions of the sample cause measurable changes in
the overall potential.

Nernst equation

The potential difference across the membrane in the sensor can be expressed by the
Nernst equation:

RT
Esample=E0 + ´ ln ax
nF

Where:

ESample = Potential between the reference electrode and the ion-sensitive membrane

E0 = Reference electrode potential

R = Gas constant (8.3143 J/°K-mole)

T = Absolute temperature (°K)

n = Charge on the ion

F = Faraday constant (96487 C/mole)

ax = Activity of the species x

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Activity and concentration

The Nernst equation lets you calculate the activity of known concentrations of samples
(pH and electrolytes).

The measured activities are used to calculate the concentrations by the use of the cali-
bration results of the analyzer.

Calibration - pH and electrolyte sensors

Calibrations of pH and electrolyte sensors

The sensitivity calibration of the pH and electrolyte sensors gives the slopes of the cali-
bration lines. Status calibrations are done with every measurement to compensate for
small variations in sensor performance between calibrations.
Related information
Details about calibration frequency, page 174

Calculation of pH and electrolytes sensitivity

The sensitivity value shown in calibration results shows how much the sensitivity of a
sensor differs from the sensitivity of a theoretical sensor.

The sensitivity is calculated as follows:

pH sensor sensitivity:

mVcal2 -mVcal1
S=
-61.5mV× (pHcal2 -pHcal1 )

Electrolyte sensor sensitivity:

n (mVcal2 -mVcal1 )
S=
æc ö
61.5mV×log10 ç cal2 ÷
è c cal1 ø

Where:

• S is the sensitivity
• mVcal1 and mVcal2 are the signals measured by the sensor and when CAL1 and CAL2
solutions are used
• ccal1 and ccal2 are the concentrations of the electrolyte in the CAL1 and CAL2 solu-
tions
• n is the ionic charge

Status is defined as the sensor signal when CAL 1 solution is used.

Measurement - pH and electrolyte sensors

Calculation of pH and electrolyte values

The pH value measured from the sample is calculated as follows, from the sensor
signal of the sample mVsample:

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mVsample -mVcal1
pH=pHcal1=
-61.5mV×S

The electrolyte concentration in a sample is calculated from this equation:

(
n Esample -Ecal1 )
c = c cal1×10 61.5mV×S

where n is the ionic charge. The measured value is applied a linear correction:

cdisplayed = k1 × c + k2

NOTE: cCl- is compensated for cHCO3- interference by the use of the measured pH and
pCO2, before the linear correction is applied.

Sensor response stability

The sensor response stability is the standard deviation of the last 5 calculated status
calibration values.

pCO2 sensor

Construction - pCO2 sensor

Construction

1 2

3
4
6 5

1 Silicone membrane – A membrane 5 Solid-state contact for the pH

that separates the sample and the system. The point of electrical
electrolyte solution. Is only perme- contact between the pH membrane
able to CO2 and H2O and the analyzer.

2 Electrolyte solution – A bicarbonate 6 Electrical contact between the

buffer that changes pH upon reference electrode and the
absorption/desorption of CO2 from analyzer
the sample

3 pH membrane – H+ sensitive 7 Sensor base – The structural plat-

membrane form on which the sensor is formed

4 Reference electrode – Ag/AgCl

electrode

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Measurement principle - pCO2 sensor

Electrode chain

The electrode chain (or electrical circuit) set up to measure pCO2 is shown in the
diagram:

1
V

2 3 4

1 Voltmeter – Measures the voltage 3 Electrolyte solution – Medium for

potential in the circuit connection

2 pH electrode – Provides electrical 4 Internal reference electrode

connection to the voltmeter (Ag/AgCl) – Provides electrical
connection to the voltmeter

Electrode chain potential

The potential differences at all the junctions in the electrode chain are known and
constant, except that at the pH-sensitive membrane. (See the section pH and electro-
lyte sensors for a full explanation.)

The potential difference at the pH-sensitive membrane depends on the pH of the elec-
trolyte solution, which in turn depends on the CO2 content of the sample. This is
explained in the Measuring process topic.

Measurement process in the pCO2 sensor

This is an account of the measurement process in the pCO2 sensor.

Part Function

Transport of CO2 CO2 from the sample permeates the membrane

Dissolution of The CO2 dissolves in the electrolyte solution. This produces carbonic acid:
CO2
H2O + CO2 ⇔ H2CO3

Dissociation of Carbonic acid dissociates according to the this equilibrium reaction:

carbonic acid
H2CO3 ⇔ H+ + HCO3-

pH change The release of H+ ions changes the H+ concentration, and thus the pH of the
inner buffer solution on one side of the pH-sensitive membrane

Measurement of The concentration gradient of H+ ions across the membrane creates a poten-
potential tial difference across the membrane.

This change in potential across the membrane is measured by the voltmeter.

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Part Function

Relation of pH The pH value is related to the partial pressure of CO2 in the sample by this
to pCO2 equation:

éHCO3- ùû
pH = pK a + log ë
a×pCO2

Where: pKa = -log Ka , the equilibrium constant for the dissociation of

carbonic acid in water

α = solubility coefficient for CO2 in water

The structure of the pCO2 sensor is similar to the pH sensor, including the
presence of a pH-sensitive membrane. The major difference is in the internal
electrolyte solution present in the pCO2 sensor which allows the dissolution of
CO2 and ultimate dissociation of carbonic acid mentioned above. If [cHCO3-]
and α in the electrolyte solution are constant, it results in this equation: pH =
K - log pCO2

Where K contains the equilibrium constant pKa , the solubility coefficient α and
the concentration of bicarbonate [cHCO3 -].

E = E'0 - 61.5 × pH = E0 + 61.5 × log pCO2.

Calibration - pCO2 sensor

Calibrations of the pCO2 sensor

The sensitivity calibration of the pCO2 sensor gives the slope of the calibration line.
Status calibrations are done with every measurement to compensate for small varia-
tions in sensor performance between calibrations.

Calibration levels

The ABL90 FLEX PLUS analyzer is equipped with a Solution Pack. This pack contains
precision-tonometered fluids. The tonometry calibration gas mixture is of a known
composition.

The partial pressure of CO2 (pCO2) and the solution pH values are known and
contained in the Solution Pack smart chip.

Calculation of pCO2 sensitivity

The sensitivity value shown in calibration results shows how much the sensitivity of a
sensor differs from the sensitivity of a theoretical sensor.

The sensitivity is calculated as follows:

mVcal2 -mVcal1
S=
æ pCO2 (cal2) ö
61.5mV×log10 ç ÷
è pCO2 (cal1) ø

Where
• S is the sensitivity
• mVcal1 and mVcal2 are the signals measured by the sensor when CAL1 and CAL2
solutions are used
• pCO2(cal1) and pCO2(cal2) are the concentrations of pCO2 in the CAL1 and CAL2
solutions

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Status is defined as the sensor signal when CAL 1 solution is used.

Measurement - pCO2 sensor

Calculation of pCO2 values

The pCO2 value measured from the sample is calculated as follows, from the sensor
signal of the sample mVsample:
Esample -Ecal1

pCO2 = pCO2 (cal1)×10 61.5mV×S

The measured value is applied as a linear correction:

cdisplayed = k1 × c + k2

Sensor response stability

The sensor response stability is the standard deviation of the last 5 calculated status
calibration values.

pO2 sensor

Measurement principle - pO2 sensor

Optical system for pO2

The optical system for pO2 is based on the ability of O2 to reduce the intensity and
time constant of the phosphorescence from a phosphorescent dye that is in contact
with the sample.

The optical system for pO2 is shown in the diagram:

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1
4

2 5

3 7

1 Dichroic mirror 5 Phosphorescence

2 Photodetector 6 Sample

3 Green LED 7 Excitation light

4 pO2 sensor

Measurement sequence

The green LED emits light, which is reflected by a dichroic mirror onto the pO2 sensor.
Due to the phosphorescence, red light is emitted back through the dichroic mirror and
onto a photo detector. The photo detector sends the electrical signals, proportional to
the light intensity, to the analog/digital converter and the data processing unit that
calculates the pO2 concentration.

Calculations

The pO2 is calculated on the basis of the Stern-Volmer equation, which describes the
relationship between the phosphorescence intensity/time constant (τ) and the pO2
value in a sample:

æt ö
pO2 (t ) =k× ç 0 -1 ÷
èt ø

Where k and τ0 are constants.

Calibration - pO2 sensor

Overview of pO2 calibrations

Ambient air is used to do a sensitivity calibration of the pO2 sensor. A status calibration
is done before every measurement to check the performance of the sensor between
sensitivity calibrations.

Sensitivity

The sensitivity is defined as the percentage of the measured pO2 on ambient air
compared to the reference value:

pO2 (meas )
S=
pO2 (ref )

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Where pO2(ref) is the pO2 tension in ambient air saturated with water vapor:

pO2(ref) = FO2 · (p(amb) - pH2O)

where FO2 is the pO2 fraction in ambient air, and pH2O is the partial water vapor pres-
sure of saturated air at 37 °C, and p(amb) is the barometric pressure.

Status

In connection with the sensitivity calibration done on ambient air, also the CAL 1 solu-
tion is measured to obtain a status. This status aims to check the performed calibra-
tion. This is done by a compare the measured value of the CAL 1 solution to the refer-
ence value of CAL 1, given by the smart chip:

pO2(status,cal) = pO2(CAL 1, cal) - pO2(CAL 1, ref)

For every measurement, the pO2 calibration is checked by a compare of the measured
value of CAL 1 solution to the value obtained on the CAL 1 solution of the last calibra-
tion (CAL 1, cal):

pO2(status, meas) = pO2(CAL 1,meas) - pO2(CAL 1, cal)

The CAL 1 solution is used to do a status calibration of the pO2 sensor. The measured
value of the CAL 1 solution is compared to the reference value of the CAL 1 solution
that is read from the smart chip of the Solution Pack.

pO2(status,cal) = pO2(CAL 1,meas) - pO2(CAL 1, ref)

The status calibration of the pO2 sensor is done before every measurement. The meas-
ured value of the CAL 1 solution is compared with the value obtained during the
previous status calibration to determine the status drift:

pO2(status,drift) = pO2(CAL 1,meas) - pO2(CAL 1,prev cal).

Measurement - pO2 sensor

Calculation of pO2 values

On blood, pO2 is adjusted with the sensitivity value and the measured pO2 is therefore
determined as follows:

pO2 (meas )
pO2 ( sens,adjusted) =
S

The measured value is applied as a second-order blood correction, to compensate for

the varying buffer value of blood, as a function of pO2 tension. A second-order correc-
tion is applied:

pO2(display) = k1pO22 + k2pO2 + k3

NOTE: Air bubbles in samples may collect in front of the pO2 sensor and cause incor-
rect results. However, the analyzer will detect them and attach a message to the
results.

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Glu and Lac sensors

Construction - Glu and Lac sensors

Construction - Glu and Lac sensors

The cGlu and cLac sensors are three-electrode sensors which consist of an internal
silver/silver chloride reference electrode, a platinum auxiliary electrode, and a platinum
anode. The sensors are covered by a multi-layer membrane bound to the sensor board.

1
2
3
5 4
6 7

1 Biocompatible layer – Biocompat- 5 Reference – Ag/AgCl electrode

ible layer

2 Outer membrane – Outer 6 Anode – Platinum electrode

membrane permeable to
glucose/lactate – diffusion control

3 Enzyme layer – Contains 7 Cathode – Platinum electrode

glucose/lactate oxidase

4 Inner membrane – Cellulose 8 Sensor base – The structural plat-

acetate form on which the sensor is formed

Zero current - Glu and Lac sensors

The zero current is a small background current measured by the electrode when no
cGlu/cLac is present in a solution. As CAL 1 solutions contain no glucose or lactate, a
baseline that represents the zero current, I0 as a function of time (I0 = f(t)), is
obtained from continuous measurements on CAL 1 solutions.

This I0 baseline is obtained as follows:

• At the end of a rinse, with CAL 1 solution in the measuring chamber, the zero
current of the metabolite electrodes is measured periodically.
• The previous N (N = 8) measurements on the CAL 1 solution - before a calibration
or a sample measurement starts - are used to obtain a baseline that represents the
time function of I0.
• The baseline is extrapolated throughout the whole electrode calibration or sample
measurement period, and represents the zero current time function.
• The I0 baseline is used in the determination of the sensitivity of the cGlu/cLac
sensor by being the reference baseline subtracted from the signal currents.

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Calibration - Glu and Lac sensors

Calculation of sensitivity – Glu and Lac sensors

The sensitivity of the Glu and Lac sensors is calculated by measuring the current from
CAL 3 solution, then subtracting the zero current as measured from CAL 1 solution.
CAL 3 solution has a nominal glucose concentration of 10 mmol/L and a nominal
lactate concentration of 10 mmol/L. The precise values are specific for the individual lot
of the Solution Pack and are contained in the Solution Pack smart chip.

The current at the Glu and Lac sensors with CAL 3 solution in the measuring chamber
is measured at regular intervals after the chamber is filled with solution. The current,
when signal stability is reached, is used to determine the sensitivity of the Glu or Lac
sensor.

The sensitivity of the Glu or Lac sensor is calculated as follows:

Ical3 -I0
S=
c cal

where I0 is the zero current extrapolated to the time of measurement from the 8
samples taken on CAL 1 solution.

Status is defined as I0.

Measurement - Glu and Lac sensors

Calculation of Glu and Lac values

The glucose or lactate concentration in a sample is calculated from the equation shown
below, where the difference between the current in the sample and the extrapolated
zero current from the rinse solution is used:

Isample -I0
c=
S

The measured value is found after this linear correction has been applied:

cdisplayed = k1 × c + k2

NOTE: cLac is compensated for the dependence of the ionic composition by the use of
the measured electrolyte values before the linear correction is applied. If the electro-
lytes are not measured, then cLac measurement is disabled.

Sensor response stability of the glucose and lactate sensors

For CAL 1 solution, the sensor response stability is defined as the standard deviation of
the last 5 calculated status calibration values.

For CAL 3 solution, the sensor response stability is defined as the standard deviation of
a linear regression for the last 5 calculated status calibration values, normalized with
the signal magnitude.

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Measurement principle - Glu and Lac sensors

Amperometric measurement principle for Glu and Lac sensors

Glucose and lactate sensors are measured according to the amperometric measure-
ment principle, in which the magnitude of an electrical current that flows through an
electrode chain is related to the concentration of a substance that is oxidized or
reduced at an electrode in the chain.

Electrode chain – Glu and Lac sensors

The electrode chain set up to measure glucose/lactate is illustrated in the diagram:

1
7

6 2

5
3
4

1 Ammeter – Measures the current 5 Electrolyte – Provides electrical

that flows through the circuit in contact between the anode and
nanoamperes cathode

2 Cathode – Negative electrode 6 Anode – Positive electrode where

where a reduction reaction occurs an oxidation reaction occurs and
and electrons are consumed electrons are released

3 Membrane – Lets the appropriate 7 Applied voltage – Applies the

molecules to pass through from the necessary potential for the reduc-
sample tion or oxidation reaction under
study
4 Sample – Contacts the membrane

NOTE: Note that polarization voltage is applied between the anode and the reference
electrode (not shown). The current runs through the anode and cathode chain.

Measurement process – Glu and Lac

A constant polarization voltage is applied to the electrode chain. The current through
this chain is measured by an ammeter.

Dissolved glucose or lactate molecules, in solution, are transported across the outer
layer of a multilayer membrane system. The enzymes glucose oxidase or lactate
oxidase, immobilized between the outer and inner layers, converts glucose/lactate
according to these reactions:

Glucose: Glucose + H2O + O2 ® Gluconic Acid + H2O2

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Lactate: Lactate + O2 ® Pyruvate + H2O2

The oxygen for this reaction is supplied by the membrane system as well as by the
oxidation of H2O2 at the platinum anode.

The H2O2 produced by the enzyme reaction is transported across the inner membrane
to the platinum anode.

When a potential is applied to the electrode chain, the oxidation of H2O2 produces an
electrical current proportional to the amount of H2O2, which in turn is directly related
to the amount of glucose/lactate.

H2O2 ® 2H+ + O2 + 2e-

At the counter electrode a reduction process that consumes electrons will occur:

1. H2O2 + 2e- ® 2OH- (This process consumes excess H2O2 not consumed in the
reaction above)
2. ½O2 + H2O + 2e- ® 2OH- (This process consumes excess O2 not consumed in the
reaction above)
3. 2H2O + 2e- ® H2 + 2OH- (This process occurs only at the cathode)

Any of these three reactions at the cathode will serve to neutralize the protons gener-
ated in the second reaction, so the total change in acidity is caused by the gluconic
acid/pyruvate only.

Creatinine sensors

2-sensor configuration

For the purpose of creatinine measurements, a 2-sensor system is utilized where one
sensor (the 2-enzyme sensor) detects creatine only, and the other sensor (the
3-enzyme sensor) detects both creatine and creatinine. By means of a difference
measurement, it is possible to obtain the creatinine value. The concept of this
two-sensor system can be qualitatively described by the following set of equations:

I2-enz. = S2-enz.
Creatine ´ cCreatine

I3-enz. = S3-enz. 3-enz.

Creatine ´ cCreatine + SCrea ´ cCrea

where:

cCrea = Concentration of creatinine

cCreatine = Concentration of creatine

SCrea = Creatinine sensitivity

SCreatine = Creatine sensitivity

I^2-enz. = Amperometric signals (electric current) measured at the 2-enzyme sensor

I^3-enz.= Amperometric signals (electric current) measured at the 3-enzyme sensor

Construction - Creatinine sensors

The 2-enzyme and 3-enzyme sensors are three-electrode sensors which consist of an
internal silver/silver chloride reference electrode, a platinum counter electrode, and a
platinum anode. The sensors are covered by a multi-layer membrane bound to the
sensor board.

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1
2
5
3
4 6
7

1 Outer membrane – Outer 5 Cathode – Platinum electrode

membrane permeable to creati-
nine/lactate – diffusion control

2 Enzyme layer 6 Anode – Platinum electrode

◦ 3-enzyme sensor has 3
enzymes: creatininase, creati-
nase, and sarcosine oxidase
◦ 2-enzyme sensor has 2
enzymes: creatinase and sarco-
sine oxidase

3 Interference removing layer – 7 Sensor base – The structural

Cellulose acetate ceramic platform on which the
sensor is formed
4 Reference – Ag/AgCl electrode

Zero current - cCrea

The zero current is a small background current measured by the electrode when no
creatinine is present in a solution. As CAL 1 solutions contain no creatinine or creatine,
a baseline that represents the zero current, I0 as a function of time (I0 = f(t)), is
obtained from continuous measurements on CAL 1 solutions.

This I0 baseline is obtained as follows:

• At the end of a rinse, with CAL 1 solution in the measuring chamber, the zero
current of the metabolite electrodes is measured periodically.
• The previous N (N = 8) measurements on the CAL 1 solution - before a calibration
or a sample measurement starts - are used to obtain a baseline that represents the
time function of I0.
• The baseline is extrapolated throughout the whole electrode calibration or sample
measurement period, and represents the zero current time function.
• The I0 baseline is used in the determination of the sensitivity of the Creatinine
sensors.

Determination of analyte levels in the calibrators

Due to the tendency of creatinine and creatine to seek equilibrium, the concentration
of these analytes in the calibration solutions changes over time. Thus a method is
implemented for determining the actual analyte levels in the calibrators before each
calibration routine.

Calculation of sensitivity – Creatinine

The sensitivities of the 2-enzyme and 3-enzyme sensors are calculated using CAL 3
and CAL 4. The measured current, minus the zero current, together with the corrected
creatine and creatinine concentrations of CAL 3 and CAL 4 in the solution pack are used
for these calculations.

The sensitivities are range-checked:

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cCrea

5 pA/µM ≤ sCr2 ≤ 35 pA/µM

5 pA/µM ≤ sCrn3 ≤ 30 pA/µM

5 pA/µM ≤ sCr3 ≤ 35 pA/µM

Calculation of cCrea values

I3-enz. 3-enz.
Crea - SCreatine ´ cCreatinesample
cCreasample =
S3-enz.
Crea

I2-enz.
cCreatinesample = Creatine
S2-enz.
Creatine

Measurement process – creatinine

A constant polarization voltage is applied to the electrode chain. The current through
this chain is measured by an ammeter.

Creatine and creatinine molecules, in solution, are transported across the outer layer of
a multilayer membrane system. The enzymes creatinase, creatininase and sarcosine
oxidase immobilized between the outer and inner layers, converts the creatine and
creatinine to hydrogen peroxide according to these reactions:
Creatininase
Creatinine+H2O ¾¾¾¾ ® Creatine

Creatinase
Creatine+H2O ¾¾¾ ® Sarcosine+Urea/BUN

Sarcosine oxidase
Sarcosine + H2 O + O2 ¾¾¾¾¾ ® Glycine + H2 O2 + Formaldehyde

Pt anode
H2 O2 ¾¾¾¾ ® O2 + 2H+ + 2e-

The hydrogen peroxide is then converted to a current at the electrode which is meas-
ured by the analyzer.

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Electrode chain – creatinine

The electrode chain set up to measure creatinine is illustrated in the diagram:

1
7

6 2

5
3
4

1 Amperemeter – Measures the 5 Electrolyte – Provides electrical

current that flows through the contact between the anode and
circuit in nanoamperes cathode

2 Cathode – Negative electrode 6 Anode – Positive electrode where

where a reduction reaction occurs an oxidation reaction occurs and
and electrons are consumed electrons are released

3 Membrane – Lets the appropriate 7 Applied voltage – Applies the

molecules to pass through from the necessary potential for the reduc-
sample tion or oxidation reaction under
study
4 Sample – Contacts the membrane

NOTE: Note that polarization voltage is applied between the anode and the reference
electrode (not shown). The current runs through the anode and cathode chain.

Sensor response stability of the creatinine sensors

The stability of the sensors is determined by the shape of the current vs time measure-
ment curve which is called the response curve. The ratio of B to A shall be below a set
limit where B is the slope of the second half of the response curve and A is the slope of
the first half of the response curve.

Urea/BUN sensors

Construction

The urea/BUN sensor is of a solid state design consisting of an enzyme layer which
converts the urea to ammonium and an ion selective layer that is sensitive to ammo-
nium.

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1
2 3
4
5

1 Enzyme containing layer - the 4 Gold contact pad

enzyme urease converts the urea
in the sample to ammonium

2 Membrane - Ammonium selective 5 Electrical contact – The point of

membrane that is in direct contact electrical contact between the
with the sample or calibration solu- sensor and the analyzer
tion and that is sensitive to ammo-
nium ions

3 Solid-state contact – The point of 6 Sensor base – The structural plat-

electrical and ionic contact with the form on which the sensor is formed
membrane

Potentiometric measurement principle

The urea/BUN sensor is measured according to the potentiometric measurement prin-

ciple, where the potential of an electrode chain recorded at a voltmeter is related to
the concentration of a substance via the Nernst equation.

Electrode chain potential

Every element in the electrode chain contributes a voltage to the total potential drop
through the chain.

The total potential across the electrode chain, therefore, is the sum of these separate
potentials, all but one of which are known and constant, as outlined in the table:

Element Potential Symbol

Reference electrode Known and constant when the Ag/AgCl is Eref

immersed in the electrolyte solution

Liquid junction between the electrolyte Known and constant. Independent of ELJ
solution in the reference electrode, the sample composition .
sample, and the enzyme layer

Ion-sensitive membrane that separates the Unknown. Dependent on sample compo- ESample
sample and the urea/BUN sensor sition.

Solid-state contact Known and constant EE

Total potential Measured by the voltmeter Etot

Derived potential

The unknown potential difference across the ion-sensitive PVC membrane is the differ-
ence between the measured total potential and the sum of the known potentials:

Esample = Etotal - (Eref + ELJ + EE)

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Enzyme layer

Urea cannot be detected directly so we use an enzyme layer where urea is converted
by urease in the below equation and is subsequently detected at the ion sensitive
membrane.

CO(NH2 )2 +3H2O ¾¾
Urease
®2NH4+ +HCO3- +OH-

Ion-sensitive membrane

The potential difference across the membrane arises as a consequence of a change in

the charge balance at the membrane.

The membrane is sensitive to ammonium ions in that it has an ion-exchange ability.

The internal solid-state reference electrode maintains the internal potential at the same
level. Changes in the ammonium ions of the sample cause measurable changes in the
overall potential.

Nernst equation

In the case of the urea/BUN sensor, the analyte urea cannot be directly sensed by
potentiometric methods. This necessitates the use of an enzyme layer to convert the
urea into ammonium ions which can then be sensed by an ISE. The ammonium sensor
is mathematically represented as a K+ sensor with an ammonium ion interference.
Thus the electrode potential in this sensor can be represented by the following Nernst
equation:

(
E=E0 + Nf ´ log cK+ + k1 ´ cNH+4 + k 2 ´ cNa+ )
Where:

E = the electrode potential measured against the reference electrode (mV)

E0 = standard electrode potential (mV)

Nf = the Nernst sensitivity (mV/dec) (constant value)

cK + , cNH4+ , cNa+ = concentrations of potassium, ammonium and sodium ions in the

measured volume, respectively (mM)

k1 = the ammonium : potassium selectivity ratio (calibrated value)

k2 = the sodium : potassium selectivity ratio (constant value)

Calibration of the urea/BUN sensor

The urea/BUN sensor uses Cal 2, Cal 3 and Cal 4 to determine the ammonium to
potassium selectivity as well as 2 parameters that reflect the properties of the enzyme
layer.

Calculation of cUrea/BUN values

æ1ö é + ù
dEsample
+
cNH4,sample (
= ç ÷ ´ ê cKrinse +
+ k 2 ´ cNarinse )
´ 10 Nf - cK sample
+ +
- k 2 ´ cNasample ú
1. è k1 ø êë ú
û
where:

k1: NH+4:K+ selectivity

k2: Na+:K+ selectivity

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practical Nernst sensitivity Nf, Sens = 60.5 mv/dec

NOTE: ISE is sensitive to sodium and potassium as well as ammonium.

2. Using the ammonium concentration previously determined, the pH value of the
sample found by the analyzer, and the enzyme layer properties which were found
through calibration, an aqueous-equivalent urea/BUN concentration is determined.
3. A blood-corrected urea value is then determined through the use of the
aqueous-equivalent urea value, as well as the ctHb concentration determined by
the analyzer.
4. If the analyzer is configured for BUN, urea is converted to BUN.

Sensor response stability of the urea/BUN sensor

The urea/BUN sensor response stability is calculated as the standard deviation of the
last 8 electrode measurements.

ctHb and derivates

Description of the optical system

Measured parameters

The optical system of the ABL90 FLEX PLUS analyzer is designed to measure these
parameters:

Parameter Description

ctHb Concentration of total hemoglobin

sO2 Oxygen saturation

FO2Hb Fraction of oxyhemoglobin

FCOHb Fraction of carboxyhemoglobin

FHHb Fraction of deoxyhemoglobin

FMetHb Fraction of methemoglobin

FHbF Fraction of fetal hemoglobin

ctBil Concentration of total bilirubin (the sum of unconjugated and conjugated bilirubin)
in plasma

NOTE: ctBil can be measured on blood or plasma samples. Plasma samples provide the
optimal measurement performance. To obtain optimal accuracy when following a
patient trend in ctBil, use the same sample type and the same analyzer.

Construction

The optical system is based on a 256-wavelength spectrophotometer with a measuring

range of 467-672 nm. The spectrophotometer is connected via an optical fiber to a
combined hemolyzer and measuring chamber.

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1
2
8
7
3
4 9
6 10
5 11

1 Spectrophotometer 7 Hemolyzer

2 Array of photodiodes 8 Hemolyzing unit

3 Grating 9 LED light source

4 Mirrors 10 Cuvette

5 Slit 11 Sample

6 Optical fiber cable

Measurement cycle

The method used in the analyzer's optical system is visible absorption spectroscopy.
The measurement cycle is as follows:

1. The blood sample is transported to the cuvette in the hemolyzer unit. The temper-
ature of the cuvette is adjusted to 37 °C.
2. A back pressure is exerted on the sample. This one atmosphere over-pressuriza-
tion is maintained during the hemolyzation and measurement to remove air
bubbles in the sample and to enhance the hemolyzation process.
3. The 1-µL sample in the cuvette is ultrasonically hemolyzed at a frequency of about
30 kHz. This hemolyzation process ruptures the walls of the red blood cells and the
content of the red blood cells is evenly mixed with the plasma and an optically
clear solution is produced.
4. Light from a white LED is sent into the cuvette and the light is transmitted through
the cuvette via an optical fiber to the spectrophotometer.
5. The light passes through a slit that points the light towards an arrangement of
mirrors and a grating.
6. The grating divides the light into the colors of the rainbow and the mirror focuses
the light on a photodiode array.
7. The photodiode array, which has 256 diodes or pixels, one for each wavelength,
converts the monochromatic light signals to currents.
8. The currents are measured at each of the 256 diodes. The currents form the basis
for the absorption spectrum for a particular sample.
9. The spectrum is sent to the analyzer, which calculates the oximetry parameter
values.

Lambert-Beer's law

Absorption spectroscopy is based on Lambert-Beer's law, which states that the meas-
ured absorbance for a single compound is directly proportional to the concentration of
the compound and the length of the light path through the sample:

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l l
Ay = e y ´ cy ´ l

Where:
l
Ay = absorbance of compound y at wavelength λ

l
e y
= extinction coefficient of compound y at wavelength λ (a constant, characteristic of
the compound)

cy = concentration of compound y in sample

l = length of the light path

Absorbance

The absorbance (A) of a compound is defined as the logarithm of the ratio of the light
intensity before and after transmission through the compound.

In practice it is the logarithm of the ratio of the light intensity transmitted through
water to the light intensity transmitted through the compound.

I0
A = log
I

Where:

Io = intensity of light transmitted through water (I0 is measured as the intensity of

light transmitted through CAL 3 solution)

I = intensity of light transmitted through the compound

Total absorbance

For samples that contain more than one optically active compound, the total absorb-
ance (Atotal) is the sum of the individual compounds' absorbance, since absorbance is
an additive quantity.

For example, if a sample contains six compounds y1, y2, ….y6, the total absorbance
measured for that sample at wavelength λ 1 is:
l l1 l1 l1 l1 l1 l1
A 1 = Ay + Ay + Ay + Ay + Ay + Ay
total 1 2 3 4 5 6

( l1 l1 l1
= l e y cy1 + e y cy2 + e y cy3 + e y cy4 + e y cy5 + e y cy6
1 2 3
l1

4
l1

5
l1

6
)
If there are Y compounds and measurements are made at n wavelengths, a general
expression can be written for Atotal at the wavelength λn:

Y
å e yl
l
A n
= n
´ cy ´ l
total
y =1

Where:

λn = the individual wavelengths.

Continuous spectrum
ln
Atotal can be depicted graphically as a function of wavelength, and if the differences
between the wavelengths are small enough, a continuous spectrum is produced.

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Spectrum examples

The figure below shows three spectra; pure O2Hb, pure HHb at a low concentration, a
spectrum of 92% oxygenated hemoglobin that is obtained by adding the spectra of
O2Hb and HHb. The additivity of absorption and the continuity of the spectra can be
seen.

1
3

5
2
480 500 520 540 560 580 600 620 640 660 680

1 Absorption 4 FO2Hb (9.2 mmol/L)

2 Wavelength (nm) 5 FHHb (0.8 mmol/L)

3 92% FO2Hb, 8 % FHHb

Example of the spectrum obtained from unconjugated bilirubin at a concentration of

200 µmol/L.

0.1
1
0.08

0.06

0.04

0.02
0 nm 2
470 520 570 620 670

1 Absorption 2 Wavelength (nm)

The spectrum of conjugated bilirubin is slightly different.

Determining concentrations

In the measured spectrum of a sample, the absorption recorded at each wavelength

contains contributions from each of the compounds in the sample. The task then is to
determine the magnitude of that contribution and thereby the concentration of each
compound in the sample.

The concentrations are determined as follows:

138
cy = å K l Al
n =1
y
n n
total

λ
Where K yn = a constant specific to compound y at wavelength λn.

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Matrix of constants
λ
The constants ( K yn ) are determined by the use of the Multivariate Data Analysis [1]
where the spectra of the calibration compounds are considered together with the refer-
ence values of the calibration compounds. The essential interfering substances (intrali-
pids and sulfhemoglobin) were also taken into account.

Calibration of the optical system

Calibration materials

The optical system is calibrated at two points by the use of these solutions:
• The S7770 ctHb Calibration Solution with a known dye concentration to determine
the cuvette path length, l.
• A transparent solution from the Solution Pack in the analyzer to determine the zero
point, Io.

Zero point

The zero point, Io, is the current (or intensity) measured by the photodiode array on
the transparent solution in the cuvette. During this blank calibration the ctHb is cali-
brated to this zero point.

Io is measured automatically during system start up and during calibrations.

Cuvette path length

The cuvette path length (i.e. the length of the light path) is determined from
Lambert-Beer's Law by measuring the absorbance of the colored dye present in the tHb
Calibration Solution (S7770), which has a known equivalent hemoglobin concentration.

Beer's Law: A = ε x Cdye × l

Where

A = absorbance

ε = extinction coefficient

Cdye = concentration of colored dye

l = length of light path

Correcting for interferences

HbF versus HbA

Fetal hemoglobin (HbF) does not have the same spectrum as adult hemoglobin (HbA)
due to a slight variation in molecular structure. The presence of HbF in a sample will
interfere with the result if a correction is not made.

Therefore, when hemoglobin levels are measured in samples from premature neonates
and neonates aged 0-3 months, as well as from adults who suffer from e.g. thalas-
semia, it is important to take into account this difference [2], and to make sure that
the analyzer automatically corrects for HbF.

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NOTE: The analyzer only compensates for interference caused by the presence of HbA
and HbF.

The diagram shows the transition from fetal hemoglobin to adult hemoglobin [2].

%
100
1 HbF HbA

80

60

40

20

0 2
-6 -3 0 3 6

1 Hemoglobin 2 Months

This graph is only schematic and cannot be used to determine FHbF.

Deviation of results

If the difference between the adult and fetal types of hemoglobin is not taken into
account in measurements on samples that contain HbF (e.g. from premature neonates
and neonates aged 0-3 months) then a deviation in the measurement will occur.

The deviation is most important for measurements of oxygen saturation (sO2 and
FO2Hb) and the fraction of carboxyhemoglobin (FCOHb), since inaccurate measure-
ments of these parameters can lead to incorrect diagnostic interpretation of the
results, and consequent risk of inappropriate treatment.

Detecting HbF

The presence of HbF in a sample is detected by measuring the difference between the
spectra of fetal and adult oxyhemoglobin. Fetal oxyhemoglobin, cO2HbF, is determined
by the difference.

Correcting for HbF

The amount of cO2HbF that exceeds a certain level indicates HbF interference. The
analyzer automatically corrects for this interference by subtracting the difference spec-
trum of fetal oxyhemoglobin from the measured spectrum.

Repressing spectra

Repressing the spectra of the likely interfering substances is done in two ways
depending on the substance:
• Either the substance is taken account of in the calculation of the matrix of
constants, K. This applies to Intralipids and Sulfhemoglobin.
• Or the substance is detected, and the measured spectrum is corrected accordingly.
This applies to HbF.

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Residual spectrum

The measured spectrum is compared to a model spectrum calculated from the deter-
mined concentrations. The difference between these two spectra is called the residual
spectrum. If this residual spectrum is too high, the oximetry module parameters ctHb,
sO2, FO2Hb, FCOHb, FMetHb, FHHb, FHbF and ctBil will be flagged with a warning.

In addition, a warning will accompany the results if any of these conditions exist:
• ctHb <–0.1 mmol/L or ctHb >25 mmol/L
• FHb(deriv) <–2 % or FHb(deriv) >102 % where FHb(deriv) is defined as sO2,
FO2Hb, FCOHb, FMetHb, FHHb
• SHb <–2 % or SHb >10 %
• Value of turbidity <- 0.5 % or > 5 %

Measurement and corrections

Calculation of the values of the oximetry parameters

The oximetry parameters are calculated as follows:

Parameter Equation

ctHb(meas) = cO2Hb + cCOHb + cHHb + cMetHb

sO2 cO2Hb
=
ceHb
ceHb = cHHb + cO2Hb (effective hemoglobin)

FO2Hb cO2Hb
=
ctHb

FCOHb cCO2Hb
=
ctHb

FHHb cHHb
=
ctHb

FMetHb cMetHb
=
ctHb

FHbF cHbF
=
ctHb

Bilirubin

Bilirubin is calculated as follows:

ctBil(B)
ctBil(P)=
1 - Hct(calc)

Where:

ctBil(P) = concentration of total bilirubin in plasma

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ctBil(B) = concentration of diluted plasma bilirubin after sample hemolyzation

Hct(calc) = calculated hematocrit (a fraction):

0.0301
Hct(calc)= ´ ctHb
g/dl

For further details on Hct(calc) please refer to Interference Tests and the explana-
tion of MCHC (Mean Corpuscular Hemoglobin Concentration) in this manual.

Restrictions

These parameters will not be calculated:

Parameter Is not calculated if…

sO2, FCOHb, FMetHb, FHHb, FO2Hb ctHb<1 mmol/L

sO2 ceHb = cHHb + cO2Hb <0.75 mmol/L

ctBil ctHb>14.27 mmol/L

To correct for the presence of HbF in a sample, these conditions are required:

Parameter or settings Conditions

ctHb Concentration >5 mmol/L

FCOHb Concentration <20 %

FMetHb Concentration <10 %

HbF correction setting - cO2HbF/ctHb should be more than 0.2

“Enabled for levels > 20
%”

HbF correction setting - No lower limit value for cO2HbF is required. Even adult blood
“Enabled for all levels” samples will be corrected for HbF. This setting may be of value
when you analyze blood samples from newborns who have
received adult blood transfusion. In these cases FHbF can be lower
than 20% and significant deviations of oximetry parameters and
bilirubin can occur.

HbF correction setting - No HbF corrections are made

“Disabled”

HbF correction has been The message “Oxi compensated for HbF” is attached to the result
enabled

sO2<50% The message “FHbF measurement not possible” is shown by the

analyzer, if a HbF suppression has been activated, and the FHbF
estimation from cO2HbF is too uncertain

Corrections for ctHb

The uncorrected hemoglobin concentration, ctHb(sample), measured on capillary or

syringe samples is corrected as follows:

ctHb(sample)
ctHb(sample,corr)=
Fcuv

Where:

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ctHb(sample,corr) = corrected ctHb

Fcuv = analyzer-dependent cuvette path length constant determined at tHb cali-

brations and automatically saved by the analyzer

Corrections for ctBil

The uncorrected total bilirubin concentration, ctBil(sample), measured on capillary or

syringe samples is corrected as follows:

ctBil(sample)
ctBil(sample,corr)=
Fcuv

Fcuv is the same as for tHb.

References

1. Martens H. Multivariate calibration: quatitative interpretation of non-selective

chemical data: Dr. Techn. Thesuis. NTH Univ. of Trondheim, 1986.
2. Huehns ER, Beanen GH. Developmental changes in human hemoglobins. Clin Dev
Med 1971; 37: 175-203.

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Analyzer specifications

Ranges of indication and reportable ranges

Parameter Unit Range of indication Reportable range (default)

pH pH scale 6.3-8.0 6.750-7.850

pCO2 mmHg; Torr 5-250 12.0-110

kPa 0.67-33.3 1.60-14.7

pO2* mmHg; Torr 0-800 10-550

kPa 0-107 1.33-73.3

ctHb g/dL -0.48-27.7 0**-27

g/L -4.8-277 0**-270

mmol/L -0.30-17.2 0**-16.8

sO2 % -2-102 0**-100**

Fraction -0.02-1.02 0.00**-1.00**

FO2Hb % -2-103 0**-100**

Fraction -0.02-1.03 0.00**-1.00

FCOHb % -2-103 0**-100**

Fraction -0.02-1.03 0.00**-1.00**

FMetHb % -2-103 0**-100**

Fraction -0.02-1.03 0.00**-1.00**

FHHb % -2-102 0**-100**

Fraction -0.02-1.02 0.00**-1.00**

FHbF % -25-121 0-100**

Fraction -0.25-1.21 0.0**-1.00**

cK+ mmol/L; meq/L 0.5-25 1.5-10.5

cNa+ mmol/L; meq/L 7-350 95-190

cCa2+ mmol/L 0.1-9.99 0.40-2.70

meq/L 0.2-19.98 0.80-5.40

mg/dL 0.4-40.04 1.60-10.82

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Parameter Unit Range of indication Reportable range (default)

cCl– mmol/L; meq/L 7-350 70-160

cGlu* mmol/L 0-60 0-47

mg/dL 0-1081 0-847

cLac mmol/L; meq/L -0.1-31 -0.1-31

mg/dL -1-279 -1-279

cCrea*** µmol/L 10-1800 35-900

mg/dL 0.1-20 0.4-10

cUrea*** mmol/L 1-50 2-42

mg/dL 6.0-300 12-252

BUN*** mg/dL 2.8-140 5.6-118

ctBil µmol/L -20-1000 0**-690

mg/dL -1.2-58.5 0**-40.3

mg/L -12-585 0**-403

* See the Related information.

** This value is for analyzers where Out-of-range suppression is enabled. If

Out-of-range suppression is not enabled, the default reportable range is different,
see the table below.

*** Parameters only available on analyzers configured to feature creatinine and

urea/BUN.

Parameter Unit Reportable range

ctHb g/dL -0.2-27.0

g/L -2-270

mmol/L -0.12-16.8

FO2Hb, FCOHb, FMetHb % -2.0-103.0

Fraction -0.02-1.03

sO2, FHHb % -2.0-102.0

Fraction -0.02-1.02

FHbF % -25-121

Fraction -0.25-1.21

ctBil µmol/L -20-690

mg/dL -1.2-40.3

mg/L -12-403

Related information
pO2 levels - how they affect cGlu results, page 235

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Measurement precision within specified ranges

The table shows the precision (number of decimals) of the parameters within the
ranges shown. The ranges should be taken into consideration when external systems
are interfaced to the analyzer.

Parameter symbol Unit Lower range Upper range

Lower limit Upper limit Lower limit Upper limit

pH - 4.000 11.000

pH(T) - 4.000 11.000

cH+ nmol/L -999999.0 199.9 200 9999999

cH+(T) nmol/L -999999.0 199.9 200 9999999

pCO2 mmHg 0.0 99.9 100 750

kPa 0.00 9.99 10.0 100.0

pCO2(T) mmHg 0.0 99.9 100 750

kPa 0.00 9.99 10.0 100.0

cHCO3–(P) mmol/L 0.0 100.0

cBase(B) mmol/L -50.0 50.0

cBase(B,ox) mmol/L -100.0 100.0

cBase(Ecf) mmol/L -50.0 50.0

cBase(Ecf,ox) mmol/L -100.0 100.0

cHCO3– (P,st) mmol/L 0.0 150.0

ctCO2(P) mmol/L 0.0 100.0

Vol % 0.0 224.1

mL/dL 0.0 224.1

ctCO2(B) mmol/L 0.0 100.0

Vol % 0.0 224.1

mL/dL 0.0 224.1

pH(st) - 4.000 11.000

VCO2/V(dry air) % -10.0 110.0

fraction -0.100 1.100

Hct % -10.0 110.0

fraction -0.100 1.100

pO2 mmHg 0.0 99.9 100 2250

kPa 0.00 9.99 10.0 99.9

100 300

pO2(T) mmHg 0.0 99.9 100 750

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Parameter symbol Unit Lower range Upper range

Lower limit Upper limit Lower limit Upper limit

pO2(T) kPa 0.00 9.99 10.0 99.9

100 300

pO2(A) mmHg 0.0 750.1

kPa 0.00 100.00

pO2(A,T) mmHg 0.0 750.1

kPa 0.00 100.00

p50 mmHg 0.00 750.06

kPa 0.00 100.00

p50(T) mmHg 0.00 750.06

kPa 0.00 100.00

p50(st) mmHg 0.00 750.06

kPa 0.00 100.00

pO2(A-a) mmHg 0.0 750.1

kPa 0.00 100.00

pO2(A-a,T) mmHg 0.0 750.1

kPa 0.00 100.00

pO2(a/A) % 0.0 10000.0

fraction 0.000 100.000

pO2(a/A,T) % 0.0 10000.0

fraction 0.000 100.000

pO2(a)/FO2(I) mmHg 0.0 99.9 100 7501

kPa 0.00 9.99 10.0 1000.0

pO2(a,T)/FO2(I) mmHg 0.0 99.9 100 7501

kPa 0.00 9.99 10.0 1000.0

pO2(x) mmHg 0.0 750.1

kPa 0.00 100.00

pO2(x,T) mmHg 0.0 750.1

kPa 0.00 100.00

ctO2(B) mmol/L 0.0 100.0

Vol % 0.0 224.1

mL/dL 0.0 224.1

ctO2(a-v̄) mmol/L 0.0 100.0

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Parameter symbol Unit Lower range Upper range

Lower limit Upper limit Lower limit Upper limit

ctO2(a-v̄) Vol % 0.0 224.1

mL/dL 0.0 224.1

BO2 mmol/L 0.0 100.0

Vol % 0.0 224.1

mL/dL 0.0 224.1

ctO2(x) mmol/L 0.0 100.0

Vol % 0.0 224.1

mL/dL 0.0 224.1

ḊO2 mL/min 0 22414

mmol/min 0.0 1000.0

Q̇t L/min 0.0 100.0

V̇O2 mL/min 0 22414

mmol/min 0.0 1000.0

FShunt % -10.0 110.0

fraction -0.100 1.100

FShunt(T) % -10.0 110.0

fraction -0.100 1.100

RI % -10 999900

fraction -0.10 9999.00

RI(T) % -10 999900

fraction -0.10 9999.00

Qx fraction -0.10 10.0

V(B) L 0.0 20.0

Anion Gap, K+ mmol/L -500.0 500.0

meq/L -500.0 500.0

Anion Gap mmol/L -500.0 500.0

meq/L -500.0 500.0

cCa2+ (7.4) mmol/L 0.00 50.00

meq/L 0.00 100.00

mg/dL 0.00 200.40

mOsm mmol/kg -0.7 3150.0

Pressure (Baro.) mmHg 98 1500

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Parameter symbol Unit Lower range Upper range

Lower limit Upper limit Lower limit Upper limit

Pressure (Baro.) kPa 13.0 200.0

ctHb g/dL -0.81 0.99 1.0 80.6

g/L -8.1 9.9 10 806

mmol/L -0.50 0.99 1.0 50.0

sO2 % -1000.0 1000.0

fraction -10.000 10.000

FO2Hb % -1000.0 1000.0

fraction -10.000 10.000

FCOHb % -1000.0 1000.0

fraction -10.000 10.000

FMetHb % -1000.0 1000.0

fraction -10.000 10.000

FHHb % -1000.0 1000.0

fraction -10.000 10.000

FHbF % -100 200

fraction -1.00 2.00

cK+ mmol/L 0.0 100.0

meq/L 0.0 100.0

cNa+ mmol/L 0 1500

meq/L 0 1500

cCl- mmol/L 0 1000

meq/L 0 1000

cCa2+ mmol/L 0.00 50.00

meq/L 0.00 100.00

mg/dL 0.00 200.40

cGlu mmol/L -1.0 24.9 25 150

mg/dL -18 2702

cLac mmol/L -1.0 14.9 15 100

meq/L -1.0 14.9 15 100

mg/dL -9 901

ctBil mg/dL -5.8 292.3

µmol/L -100 5000

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Parameter symbol Unit Lower range Upper range

Lower limit Upper limit Lower limit Upper limit

ctBil mg/L -58 2923

cCrea* µmol/L 10 1800

mg/dL 0.1 20.0

cUrea* mmol/L 1.0 50.0

cUrea* mg/dL 6.0 300

BUN* mg/dL 2.8 99.9 100 140

GFR if AA mL/min/1.
73 m2

GFR if nonAA mL/min/1.

73 m2

GFR if JP mL/min/1.
73 m2

GFR Schwartz mL/min/1.

73 m2

Urea:Crea -

BUN:Crea -

* For analyzers configured to feature creatinine and urea/BUN.

Product specifications

Specification Value

Height 470 mm with the screen in a vertical position

Width 250 mm

Depth 290 mm

Weight <12 kg

Start Up Without the metabolite sensors: Up to 2 hours.

With the metabolite sensors: Up to 4 hours.

Start up is the period of time from when the Sensor Cassette was installed
and 3 levels of automatic QC are done. It includes the conditioning of the
Sensor Cassette, calibration and QC cycles.

Noise levels In front of the analyzer, when no activities are done: approximately 27 dB.

During automatic activities: ≤ 36 dB.

During measurements and when data is printed: ≤ 55 dB.

Volume of sample For the C 45µL mode: 45 µL.

necessary for
aspiration For all other modes: 65 µL.

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Specification Value

Measuring time For the C 45µL mode: ≤60 seconds from the time the sample is aspirated
until the results are shown.

For all other modes: 35 seconds from the time the sample is aspirated until
the results are shown.

Measurement For the C 45µL mode: 85 seconds from the time the sample is aspirated until
cycle time the analyzer is ready to analyze the next sample.

For the C 65µL and S 65µL modes: 60 seconds from the time the sample is
aspirated until the analyzer is ready to analyze the next sample.

For the C 65µL and S 65µL modes: 120 seconds from the time the sample is
aspirated until the analyzer is ready to analyze the next sample.*

For QC7+: Cycle times may be different for certain samples.

The time may be different during Start up.

* For analyzers configured to feature creatinine and urea/BUN.

Number of ≤44 samples per hour when including time spend by a trained user to
samples per hour handle the samples between measurements

Data storage Patient profiles Maximum 2000 patient profiles.

capacity log
NOTE: This number can be increased. Contact your local
Radiometer service representative to request this option.

Patient results log Maximum 2000 results

Activity log Maximum 5000 activities

Calibration log Maximum 1000 results

Quality control Maximum 2000 results

log

Replacements log This log is part of the Activity log

Archived data 500 results from each log and 2000 activities from the
logs Activity log

System messages This log is part of the Activity log

External serial 1 × RS-232 (9-pin) connector. Baud rate: 1200, 2400, 4800, 9600, 14400,
port 19200, 38400.

USB ports 3 (1 at the top and 2 in the back of the analyzer).

NOTE: Only the USB port at the top of the analyzer can be used for the WiFi
Adapter.

Ethernet 1 × RJ45 connector, 100Base-Tx Fast Ethernet

Keyboard/mouse PS/2
port

External VGA Connector for VGA screen (disabled in BIOS setting)

screen port

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Specification Value

External commu- High-level protocols:

nication protocols • ASTM
• ASTM6xx
• HL7 ver. 2.2
• HL7 ver. 2.5
• POCTDML1A

Low-level protocols:
• Serial
• Serial(Raw)
• Network(TCP/IP)
• Network(TCP/IP)(RAW)
• Network(TCP/IP)(ASTM)

Display • 8" TFT-LCD, resolution 800 x 600 VGA

• Resistive touch screen

Built-in printer Thermal printer

Built-in bar code • Reading distance: 0-70 mm

reader (under the
• Bar code width: ≥127 µm
screen)
• Number of characters: <62
• Accepted codes: Code 128, Code 39, Code 93, Interleaved 2 of 5,
Codabar

Laser specifica- Contains 1 laser that is in compliance with international standard (IEC
tions 60825-1 Safety of laser products) and US requirements (21 CFR 1040.10 -
LASER PRODUCTS).

Thermostat Solid state, 37.0 ±0.15 °C (Oxi: ±0.3 °C)

Battery pack Operation time: Approximately 45 minutes including 10 measurements

Charge time: Approximately 90 minutes to fully charge a flat battery

Voltage: 24 V

Power consump- 49 W/hour

tion:

Fuses Main fuse has two protective fuses: 5 x 20 mm, 2.5A HRC (T) 250 VAC

WiFi Supported Belkin Surf N150 Micro WLAN USB Adapter, (code
adapters number F7D1102)

TP-Link Archer T2U AC600 Mini

ASUS USB-AC51 Dual Band USB Adapter

NOTE: Only use adapters in countries where they have
been approved.

Data transfer rate Up to 150 Mbit/s

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Specification Value

WiFi Data link proto- • IEEE 802.11b

cols/standards
• IEEE 802.11g
• IEEE 802.11n
• IEEE 802.11ac

Supported • Open
authentication
• WPA/WPA2

Supported • None/WEP
encryption
• TKIP/AES
settings

Contact your local Radiometer representative to request this option.

Operating 15 °C to 32 °C
temperature

Environmental specifications

Specification Value

Location Intended for indoor use

Maximum altitude 3000 m

Ambient temperature 15-32 °C

Relative humidity 20-80 %

Barometric pressure At 15-30 °C: 525-800 mmHg

70.0-106.7 kPa

0.700-1.067 bar

525-800 Torr

At 30-32 °C 600-800 mmHg

80.0-106.7 kPa

0.800-1.067 bar

600-800 Torr

Mains power supply Rated voltage: 100-240 V ±10 %; 50/60 Hz.

Average power consumption: <60 W

Maximum power consumption: 90 W (during Start Up <106 VA for

less than a second)

Maximum voltage fluctuations: ±10 %

Class 1 power supply

Pollution degree 2 (occasional/temporary conductivity caused by condensation)

Heat dissipation <60 W

Ventilation The analyzer must be in a well-ventilated room to ensure proper

functioning.

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Specification Value

EMC – emission and The device meets the requirements of emission and immunity regu-
immunity lated in GB/T 18268.1, EN/IEC 61326-1 and GB/T 18268.26, EN/IEC
61326-2-6. This equipment has been designed and tested to GB
4824, CISPR 11 class A. In a domestic environment it may cause
radio interference, in which case, you may need to take measures to
mitigate the interference. The electromagnetic environment should
be evaluated prior to operation of the device. Do not use this device
in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF source), as these can interfere with
the proper operation.

Space requirement Sufficient space in front and on the sides of the analyzer to prevent
it overheating.

Do not put the analyzer in an enclosure.

Easy access to the mains power switch that connects the analyzer to
the mains.

Storage temperature -20 °C to 60 °C

Power-supply cords

Country Power-supply cord specifications

For USA and UL listed and KAM cord, min. type SV, min. 18 AWG, 3 conductors. Rated min.
Japan (125 60 C.
VAC)
Provided with a molded grounding-type (NEMA 5-15P) attachment plug rated
125 VAC, min. 2.5 A.

Opposite end terminates in molded IEC 320 style connector rated 125 VAC,
min. 2.5 A.

For Europe Cord type min. H05RR-F or min. H05VV-F or min. H05VVH2-F, rated min. 60
(265 VAC) C, 2 × 0.75 mm2.

Provided with a molded grounding-type attachment plug rated min. 250 VAC,
min. 2.5 A.

Opposite end terminates in molded IEC 320 style connector rated min. 250
VAC, min. 2.5 A.

The power-supply cord and plug of the analyzer must comply with national regulations.
If the regulations are not complied with, the equipment may be damaged.

External devices connected to the analyzer must be in compliance with the standard UL
60905 for US and IEC 60950 for Europe. If you do not do this, the equipment may be
damaged.

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Consumables specifications

Solution Pack

Function of the Solution Pack

For calibration of sensors, quality control, evaluation of accuracy and precision, rinse of
measuring system and collection of waste from the analyzer.

Solution Pack specifications

Two different types of Solution Packs exist: SP90 and SP90 Ki. Use SP90 Ki with config-
uration featuring creatinine and urea/BUN.

Specification SP90 SP90 Ki

Number of activities 680 and 980. An activity can 680. An activity can be a
be a patient or QC measure- patient or QC measurement, a
ment, a calibration or a rinse. calibration or a rinse.

Storage temperature 2-25 °C 2-8 °C

Storage humidity 20-80 % 20-80 %

Shelf life Stable until the expiration date Stable until the expiration date
printed on the Solution Pack printed on the Solution Pack
label label

On-board stability 30 days 14 days

Expiration date See the date printed on the See the date printed on the
Solution Pack label Solution Pack label

Contents • 3 pouches with quality • 3 pouches with quality

control material control material
• 3 pouches with calibration • 4 pouches with calibration
material material
• 1 pouch with gas mixture • 1 pouch with gas mixture
• 2 pouches to hold waste • 2 pouches to hold waste

Chemical composition Reactive ingredients: See the Reactive ingredients: See the
table below table below

Other ingredients: Biological Other ingredients: Biological

buffers, salts, enzyme, buffers, salts, enzyme,
heparin, surfactant, preserva- heparin, surfactant, preserva-
tive tive, antibiotic

Certificates of traceability Contact your local Radiometer Contact your local Radiometer
representative representative

Safety data sheet (SDS) Contact your local Radiometer Contact your local Radiometer
representative representative

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Approximate levels of measurands in the Solution Pack SP90

Parame- S9030 S9040 S9050 S1920 S1930 S1940

ters

pH 7.2 6.8 7.5 7.30 6.8 N/A

pCO2 mmHg 30 67 20 35 N/A 80

pO2 mmHg 180 N/A 20 180 N/A N/A

*cNa+ 140 118 175 150 70 N/A

*cK+ 4 7 1.8 4 10 N/A

*cCl– 105 95 125 95 50 N/A

*cCa2+ 0.8 1.65 0.3 0.5 2.3 N/A

*cGlu 0 15 7 0 N/A 10

*cLac 0 8 4 0 N/A 10

*ctHb 0 8 12 N/A N/A 0

**ctBil 0 300 450 N/A N/A N/A

* Measured in mmol/L

**Measured in μmol/L

Approximate levels of measurands in the Solution Pack SP90 Ki

Parame- S9230 S9240 S9250 CAL 1 CAL 2 CAL 3 CAL 4

ters

pH 7.2 6.85 7.5 7.3 6.8 7.1 7.1

pCO2 30 67 20 35 N/A N/A N/A

mmHg

pO2 mmHg 180 N/A 0-20 180 N/A N/A N/A

*cNa+ 140 118 175 150 67 148 148

*cK+ 4 7 1.8 4 10 4 4

*cCl– 105 95 125 95 50 N/A N/A

*cCa2+ 0.8 1.65 0.3 0.5 2.3 N/A N/A

*cGlu 0 15 7 0 0 10 0

*cLac 0 8 4 0 0 10 0

*ctHb 0 9 12 0 0 0 0

*cUrea 0 15 6 0 35 10 4

**cCrea 0 70 410 0 0 0 500

**ctBil 0 300 450 N/A N/A N/A N/A

* Measured in mmol/L

**Measured in μmol/L

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Volume of solutions in the Solution Pack SP90 and SP90 XL

Solution name Solution type Volume (mL)

QC 1 S9030 200

XL 280

QC 2 S9040 100

QC 3 S9050 100

CAL 1 S1920 200

XL 270

CAL 2 S1930 100

CAL 3 S1940 100

Volume of solutions in the Solution Pack SP90 Ki

Solution name Solution type Volume (mL)

QC 1 S9230 200

QC 2 S9240 80

QC 3 S9250 100

CAL 1 N/A 200

CAL 2 N/A 80

CAL 3 N/A 100

CAL 4 N/A 80

Chemical composition of the gas mixture in the Solution Packs SP90 and SP90 Ki

Volume (mL) Reactive ingredients

O2 % CO2 % N2

150 (at sea level) 42.07 5.61 52.32

Sensor Cassette

Function of the Sensor Cassette

For the measurement of the parameters shown on the label of the box that contains
the Sensor Cassette Pack.

Sensor Cassette specifications

Specification Details

Number of tests Depends on the Sensor Cassette version

Storage tempera- 2-8 °C

ture

Storage humidity 20-80 %

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Specification Details

Shelf life When kept in its sealed container, the Sensor Cassette is stable until the
expiration date printed on the label of the pack

On-board stability 30 days

SC90

On-board stability 14 days

SC90 Ki

Expiration date See the date printed on the label of the pack

Contents One Sensor Cassette in a sealed container

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Graphical symbols 14
Explanation of graphical symbols/icons

These are the symbols and icons you may find on the analyzer and the consumable
products used with it.

Symbol/icon Explanation

Sample mixer

Keep dry

Keep away from sunlight.

Sensitive to light. Store in a dark place.

This way up

Danger – May cause or intensify fire; oxidizer.

Keep away from clothing and combustible

materials.

Do not use if package is damaged

Do not re-use.

For one time only use.

Use by

Contains sufficient for <n> tests

Temperature limit

Lot no.

Catalog no. (product code)

Consult instructions for use and safety data

sheet

Date of manufacture

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Symbol/icon Explanation

Manufacturer

in vitro diagnostic medical device

Biohazard

Keyboard

CE marking of conformity

COM gate (scanner/barcode reader)

VGA (monitor)

Mouse

Network

Off

On

UL certification

USB

Warning or caution

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Symbol/icon Explanation

This symbol indicates that Radiometer Medical

ApS and its distributors within the European
Union (EU) and associated states have taken
the necessary steps to comply with the
"DIRECTIVE 2012/19/EU OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 4 July
2012 on waste of electrical and electronic
equipment (WEEE)".

Equipment marked with this symbol must not

be disposed of as household waste but as elec-
tronic waste in accordance with local legisla-
tion.

Please note that equipment contaminated with

potentially infectious substances, such as body
fluids, must be decontaminated before recy-
cling. If this is not possible, the equipment
must be disposed of as biohazardous material.

Contact your local Radiometer representative

for instructions.

Marks compliance with SJ/T 11363-2006

(China RoHS). The number in the symbol
shows the environmentally friendly use period
in years.

Marks compliance with SJ/T 11363-2006

(China RoHS). The product contains no
restricted substances above the prescribed
thresholds.

EurAsian Conformity mark (EAC) is a certifica-

tion mark to indicate that the products meet all
requirements of the corresponding technical
regulations of the Eurasian Customs Union.

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Ordering information 15
Solution Packs – code numbers

Item Volume Code number (REF)

SP90 680 activities 944-157

944-197 (Germany only)

SP90 XL 980 activities 944-457

944-497 (Germany only)

SP90 Ki* 680 activities 944-369

944-370 (Germany only)

* Only for use with analyzers configured to feature creatinine and urea/BUN.

Sensor Cassettes – code numbers

Sensor Cassettes are available in different versions.

Abbreviations identify the parameters that each Sensor Cassette can measure.
• BG = pH, pCO2, pO2
• LYT = cCa2+, cK+, cNa+, cCl–
• MET 1 = cGlu, cLac
• MET 2 = cCrea, cUrea/BUN
• OXI = ctHb, sO2, FO2Hb, FMetHb, FCOHb, FHHb, FHbF, ctBil

For all countries

Number of On-board Code numbers (REF) for Sensor Cassette versions

tests stability
SC90 BG, SC90 BG, SC90 BG, SC90 Ki BG,
LYT, OXI + LYT, MET 1, LYT, MET 1, LYT, MET 1,
QC OXI + QC ctHb + QC MET 2,
OXI + QC

100 30 days N/A 946-010 N/A N/A

300 30 days N/A 946-005 946-059 N/A

600 30 days 946-013 946-008 N/A N/A

900 30 days N/A 946-009 N/A N/A

1200 30 days N/A 946-060 N/A N/A

300 14 days N/A N/A N/A 946-705

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Spare parts and accessories - code numbers

Product Code number (REF)

Printer paper (8 rolls) 984-070

Clot Catcher for the ABL90 FLEX PLUS analyzer 906-026

ctHb Calibration Solution S7770 944-021

Inlet Probe 924-455

Inlet Gasket with Holder 903-585

Inlet Connector Gasket 834-662

Inlet Module 903-338

ABL90 FLEX PLUS Flush Device 905-918

ABL90 FLEX PLUS sBOX (spare parts and/or 905-956

accessories for the inlet). Contact your Radio-
meter representative for details.

Hypochlorite Solution S5362 943-906

ABL90 FLEX PLUS Roller Stand Kit (trolley for 905-907

the analyzer)

ABL90 FLEX PLUS Demo Bag (bag to transport 985-267

the analyzer)

Tubing for valve with ring 841-811

Quality control products – code numbers

QUALICHECK5+ Solutions Code number (REF)

S7730 Level 1 (marked with a red color code) 944-017

S7740 Level 2 (marked with a yellow color 944-018

code)

S7750 Level 3 (marked with a blue color code) 944-019

S7760 Level 4 (marked with a green color 944-020

code)

QUALICHECK7+ Solutions Code number (REF)

S7620 Level 0 (marked with a grey color code) 944-519

S7630 Level 1 (marked with a red color code) 944-520

S7640 Level 2 (marked with a yellow color 944-521

code)

S7650 Level 3 (marked with a blue color code) 944-522

S7660 Level 4 (marked with a green color 944-523

code)

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Range+ QUALICHECK Solutions (for cali- Code number (REF)

bration verification use)

S7930 Level 1 944-151

S7940 Level 2 944-152

S7950 Level 3 944-153

Other QC products Code number (REF)

QUALICHECK Opener/Adapter 925-214

Ampoule Opener* 920-712

QUALICHECK+ Tray 887-860

* Not for use with QUALICHECK7+

Recommended Radiometer sampling devices - code numbers

Arterial syringe packs (100 Needle gauge and length Code number (REF)
syringes/pack)

PICO50, 2 mL aspirator N/A 956-552

PICO70 without a needle N/A 956-518

PICO70 without a needle and a N/A 956-519

needle cube

PICO70 22G × 1" 956-522

PICO70 22G × 1 1/4" 956-525

PICO70 23G × 5/8" 956-529

PICO70 23G × 1" 956-533

PICO70 23G × 1 1/4" 956-534

PICO70 25G × 5/8" 956-547

safePICO70 with a needle 22G × 1¼" 956-608

shield device

safePICO70 with a needle 23G × 5/8" 956-609

shield device

safePICO70 with a needle 23G × 1" 956-624

shield device

safePICO syringe packs Dimensions Code number (REF)

(100 syringes/pack)

safePICO Self-fill with a N/A 956-610

safeTIPCAP, but without a
needle

safePICO Self-fill with a 23G × 5/8" 956-612

safeTIPCAP and a needle cube,
but without a needle shield
device

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safePICO syringe packs Dimensions Code number (REF)

(100 syringes/pack)

safePICO Self-fill with a 22G × 1" 956-613

safeTIPCAP and a needle cube,
but without a needle shield
device

safePICO Self-fill with a 22G × 1 1/4" 956-614

safeTIPCAP and a needle
shield device

safePICO Self-fill with a 23G × 5/8" 956-615

safeTIPCAP and a needle
shield device

safePICO Self-fill with a 23G × 1" 956-616

safeTIPCAP and a needle
shield device

safePICO Self-fill with a 22G × 1" 956-620

safeTIPCAP and a needle
shield device

safePICO aspirator N/A 956-622

Capillary tubes, Description Volume Number Capillary Code

glass of vials tubes/vial number
(REF)

D957G-70-100×5 Capillary tubes with 100 µL 5 75 942-878

CLINITUBES balanced heparin,
mixing wires and
end caps

D956G-70-100×1 Capillary tubes with 100 µL 1 75 905-663

CLINITUBES balanced heparin,
mixing wires and
end caps

D956G-70-45×1 Capillary tubes with 45 µL 1 75 905-954

CLINITUBES balanced heparin,
mixing wires and
end caps

D957G-70-45X5 Capillary tubes with 45 µL 5 75 942-968

CLINITUBES balanced heparin,
mixing wires and
end caps

Capillary tubes, Description Volume Capillary Code number

plastic tubes/vial (REF)

D957P-70-70×1 Capillary tubes 70 µL 250 942-898

safeCLINITUBES with balanced
heparin, mixing
wires and end
caps

D957P-70-45X1 Capillary tubes 45 µL 250 942-969

safeCLINITUBES with balanced
heparin, mixing
wires and end
caps

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Power-supply cords - code numbers

Country Mains voltage Code number (REF)

USA and Japan 120 V 615-403

UK 230 V 615-312

Italy 230 V 615-313

Danmark 230 V 615-314

Israel 230 V 615-315

Switzerland 230 V 615-316

Australia and New Zealand 230 V 615-317

South Africa and India 230 V 615-318

All other countries 230 V 615-303

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Legal information 16
Patents and trademarks

Patents

Radiometer products may be covered by one or more patents and patent applications.
See http://www.radiometer.com/en/legal/patents.

Trademarks

Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, AQURE, PICO, CLINI-
TUBES and QUALICHECK are trademarks of or used under license by Radiometer
Medical ApS.

Legal notices

System performance

The procedures described in this manual must be observed in order to ensure proper
system performance, and to avoid hazards.

Radiometer cannot provide or verify system performance characteristics if the system

is not installed, used and maintained in accordance with Radiometer procedures or if
accessories not meeting the specifications provided by Radiometer are used.

Radiometer warrants that the data media on which the software included in the system
is furnished is free from defects in material and workmanship under normal use for
three (3) months from the date of delivery as evidenced by a copy of invoice or
receipt.

Third-party software and trademarks

Use of this Radiometer product is subject to the terms and conditions of the accompa-
nying End User License Terms of Microsoft® and SAP® SQL Anywhere®. This software
is provided only for use with, and for licensed End Users of, the ABL90 FLEX PLUS
analyzer. Any other use of this software is strictly prohibited and may subject you to
legal action. Microsoft® is the trademark of Microsoft Corporation. SAP® SQL
Anywhere® software is a trademark of SAP Incorporated.

Warranties and disclaimer

Radiometer makes no warranties, express or implied, other than expressly stated.

Any warranties expressly stated in this document are conditional upon the system
being installed, used and maintained in accordance with Radiometer procedures,
including that only accessories meeting the specifications provided by Radiometer are
used.

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Radiometer disclaims any liability for system performance if the system is not installed,
used and maintained in accordance with Radiometer procedures or if accessories not
meeting the specifications provided by Radiometer are used.

Further, Radiometer disclaims any liability for loss of data and direct, consequential or
other damages, including loss of profit or loss of business, whether such claim for
damages is based upon contract, negligence or tort (including strict liability), and even
if Radiometer has knowledge of the possibility of the potential damage or loss.

Confidentiality

The contents of this document shall not be reproduced or communicated to any third
party without the prior written consent of Radiometer.

Changes

This document is subject to change without notice.

While every effort is made to ensure the correctness of the information provided in this
document as changed from time to time, Radiometer disclaims any liability for errors
and omissions.

End-user license agreement with Microsoft

You have acquired a device ABL90 FLEX PLUS analyzer that includes software licensed
by Radiometer Medical ApS from Microsoft Licensing Inc. or its affiliates (MS). Those
installed software products of MS origin, as well as associated media, printed materials,
and online or electronic documentation (SOFTWARE) are protected by international
intellectual property laws and treaties. The SOFTWARE is licensed, not sold. All rights
reserved.

• IF YOU DO NOT AGREE TO THIS END-USER LICENSE AGREEMENT (EULA), DO NOT

USE THE DEVICE OR COPY THE SOFTWARE. INSTEAD, PROMPTLY CONTACT Radio-
meter Medical ApS FOR INSTRUCTIONS ON RETURN OF THE UNUSED DEVICE(S)
FOR A REFUND. ANY USE OF THE SOFTWARE, INCLUDING BUT NOT LIMITED TO
USE ON THE DEVICE, WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA (OR
RATIFICATION OF ANY PREVIOUS CONSENT).
• GRANT OF SOFTWARE LICENSE. This EULA grants you the following license:
• You may use the SOFTWARE only on the DEVICE.
• NOT FAULT TOLERANT. THE SOFTWARE IS NOT FAULT TOLERANT. Radiometer
Medical ApS HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN
THE DEVICE, AND MS HAS RELIED UPON Radiometer Medical ApS TO CONDUCT
SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR
SUCH USE.
• NO WARRANTIES FOR THE SOFTWARE. THE SOFTWARE is provided AS IS and with
all faults. THE ENTIRE RISK AS TO SATISFACTORY QUALITY, PERFORMANCE, ACCU-
RACY AND EFFORT (INCLUDING LACK OF NEGLIGENCE) IS WITH YOU. ALSO,
THERE IS NO WARRANTY AGAINST INTERFERENCE WITH YOUR ENJOYMENT OF THE
SOFTWARE OR AGAINST INFRINGEMENT. IF YOU HAVE RECEIVED ANY WARRAN-
TIES REGARDING THE DEVICE OR THE SOFTWARE, THOSE WARRANTIES DO NOT
ORIGINATE FROM, AND ARE NOT BINDING ON, MS.
• Note on Java Support. The SOFTWARE may contain support for programs written in
Java. Java technology is not fault tolerant and is not designed, manufactured or
intended for use or resale as online control equipment in hazardous environments
requiring fail-safe performance, such as in the operation of nuclear facilities, aircraft
navigation or communication systems, air traffic control, direct life-support
machines, or weapons systems, in which the failure of Java technology could lead
directly to death, personal injury, or severe physical or environmental damage. Sun
Microsystems, Inc. has contractually obligated MS to make this disclaimer.

384 996-686C
ABL90 FLEX PLUS: Instructions for use Chapter 16: Legal information

• No Liability for Certain Damages. EXCEPT AS PROHIBITED BY LAW, MS SHALL HAVE

NO LIABILITY FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR INCIDENTAL
DAMAGES ARISING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE
OF THE SOFTWARE. THIS LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OF
ITS ESSENTIAL PURPOSE. IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN
EXCESS OF U.S. TWO HUNDRED AND FIFTY DOLLARS (USD 250.00).
• Limitations on Reverse Engineering, Decompilation and Disassembly. You may not
reverse engineer, decompile or disassemble the SOFTWARE, except and only to the
extent that such activity is expressly permitted by applicable law notwithstanding
this limitation.
• SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS. You may permanently
transfer rights under this EULA only as part of a permanent sale or transfer of the
Device, and only if the recipient agrees to this EULA. If the SOFTWARE is an
upgrade, any transfer must also include all prior versions of the SOFTWARE.
• EXPORT RESTRICTIONS. You acknowledge that the SOFTWARE is of U.S. origin. You
are to comply with all applicable international and national laws that apply to the
SOFTWARE, including the U.S. Export Administration Regulations, as well as
end-user, end-use and country destination restrictions issued by U.S. and other
governments. For additional information on exporting the SOFTWARE, see
http://www.microsoft.com/exporting/.

996-686C 385
Chapter 16: Legal information ABL90 FLEX PLUS: Instructions for use

386 996-686C
Index

2-sensor configuration............................. 341 analyzer exterior

clean..................................................52
disinfect............................................. 54
A analyzer messages
troubleshoot....................................... 96
access profiles
analyzer overview
edit access to menus.......................... 145
side and back view................................ 6
edit button shortcuts.......................... 145
analyzer status
acid-base chart
access................................................. 9
automatic printing..............................167
screen................................................10
acoustic signals
traffic light colors.................................10
mute................................................ 153
analyzer-specific control ranges
set................................................... 153
ensure width of..................................191
activity log
how to establish................................ 190
about............................................... 135
stage 1.............................................191
add message.....................................135
stage 2.............................................191
filter activities................................... 136
stage 3.............................................191
see activities..................................... 135
anonymous use
troubleshoot messages....................... 135
set up.............................................. 146
activity vs. concentration..........................322
anticoagulants
age correct
recommended and others..................... 17
cCrea results.......................................78
AQM
age groups
automatic QC management................... 57
set limits.......................................... 159
archived data logs
alarm sound settings for events
create space by moving...................... 202
default settings..................................206
export.............................................. 202
ampoule-based QC measurements
archives
do..................................................... 67
import.............................................. 202
get good.............................................63
audit trail................................................. 31
set up mode......................................157
automatic archiving
solutions for........................................62
default settings..................................213
status................................................ 69
set up.............................................. 201
ampoule-based QC results
automatic backup
find....................................................69
default setting................................... 214
messages........................................... 69
automatic data request
symbols............................................. 69
set up.............................................. 199
analysis modes
automatic data transmission
capillary........................................... 157
set up.............................................. 199
syringe............................................. 154
automatic flush......................................... 96
analysis setup
automatic printing
default settings..................................206
default settings..................................213
analyzer
set up.............................................. 200
dispose.............................................. 55
automatic quality management
flush.................................................. 93
overview............................................ 58
front view.............................................5
installation number............................ 136
lock..................................................150
move with charged battery..................140 B
move without battery......................... 140 back button
recycle............................................... 55 function..............................................14
serial number.................................... 136 backup
unlock.............................................. 150 destinations...................................... 203

996-686C 387
Index ABL90 FLEX PLUS: Instructions for use

manual.............................................203 understanding..................................... 88
schedule automatic............................ 203 calibration schedule
barcode default settings..................................210
scan.................................................. 13 calibration solutions................................. 324
barcode reader calibration verification
connect.............................................. 55 about................................................. 70
barcodes age-correct QUALICHECK7+ control
scan data from.................................. 152 ranges............................................... 76
barometric pressure frequency........................................... 70
set................................................... 154 set up mode......................................157
battery temperature-correct QUALICHECK7+
installation..........................................54 control ranges..................................... 75
service of........................................... 54 using temperature corrected results....... 75
to charge............................................54 calibration-verification ampoule
battery power........................................... 12 prepare for use................................... 71
bias....................................................... 217 calibration-verification measurement
bilirubin results do..................................................... 72
calculation........................................ 353 find result...........................................73
built-in QC measurement symbols on results............................... 74
status................................................ 60 calibration-verification results
built-in QC measurements temperature correct Range+ QUALICHECK
measurements.................................... 74
about................................................. 59
calibrations
frequency.................................... 60, 181
corrective actions for scheduled........... 176
request unscheduled............................ 60
identification in Calibration log screen.....87
built-in QC results
overview............................................ 83
find....................................................61
capillary modes
see messages..................................... 61
edit.................................................. 157
symbols............................................. 61
select a specific report layout.............. 156
troubleshoot messages......................... 62
cautions
definition..............................................3
general.............................................. 17
C cBUN
calibration performance test results..................... 251
definition.......................................... 324 cCa2+
edit schedule.....................................175 performance test results..................... 229
find results......................................... 87 traceability........................................286
frequency.................................... 83, 324 cCl-
frequency (details)............................. 174 performance test results..................... 227
request an unscheduled from Analyzer traceability........................................286
status screen...................................... 85 cCrea
request an unscheduled from menu........85 performance test results..................... 251
status................................................ 84 traceability........................................288
symbols that show the status................ 84 cCrea results
calibration equation age correct......................................... 78
about............................................... 324 centralized user management
derivation......................................... 325 set up.............................................. 148
calibration frequency cGlu
after sensor cassette SC90 replacement. 42 performance test results..................... 230
calibration log traceability........................................286
status................................................ 89 cGlu results
calibration results effect of pO2 values........................... 235
filter data........................................... 88 check buttons
messages on.......................................88 deselect............................................. 14
trends................................................ 89 select.................................................14

388 996-686C
ABL90 FLEX PLUS: Instructions for use Index

cK+ D
performance test results..................... 226 data
traceability........................................285 backup destinations........................... 203
cLac enter................................................. 13
performance test results..................... 236 restore............................................. 203
traceability........................................286 scan to enter.....................................152
cleaning data logs
analyzer exterior................................. 52 about................................................. 16
QUALICHECK Opener/Adapter............... 53 automatic archiving............................201
touch screen....................................... 52 export.............................................. 201
when is it necessary?........................... 51 format of exported............................. 201
close button overview............................................ 16
function..............................................14 data security...........................................197
clot removal............................................. 96 decimal separator....................................153
cNa+ derived parameters
performance test results..................... 227 defaults............................................ 293
traceability........................................285 definitions of acid-base....................... 294
coefficient of variation (CV %)...................218 definitions of electrolyte......................297
communication setup definitions of oximetry........................ 295
default settings..................................211 definitions of oxygen.......................... 295
concentration vs. activity..........................322 enable estimation.............................. 170
confidence intervals................................. 219 disinfecting
consumables analyzer exterior................................. 54
order................................................. 38 touch screen....................................... 53
replacement intervals........................... 38 when is it necessary?........................... 53
see an overview.................................... 8 document
see details............................................8 about this.............................................2
control ranges documents................................................. 3
about analyzer-specific....................... 190 drift
change to analyzer-specific control definition.......................................... 327
ranges..............................................191
converting to other units.......................... 313
corrective actions
for errors in built-in QC.......................184
E
for errors in QC results....................... 183 electrolyte results
for overdue calibrations...................... 176 calculation........................................ 331
for overdue scheduled QC measure- electrolyte sensors
ments.............................................. 184 calculation of sensitivity...................... 331
for pending operator activities............. 195 construction...................................... 328
system messages...............................151 measuring principle............................ 329
critical limit notification.............................. 33 status and sensitivity calibrations......... 331
critical limits environmental specifications..................... 366
about............................................... 159 equations
set up.............................................. 160 derived acid-based parameters............ 299
ctBil derived electrolyte parameters.............301
external test results........................... 248 derived oximetry parameters............... 311
performance test results..................... 246 ODC.................................................314
sensitivity for MCHC variantions........... 283 units and symbols used...................... 298
ctHb estimated Glomerular Filtration Rate.......... 299
performance test results..................... 239 external systems
traceability........................................286 interfacing with..................................359
cUrea
performance test results..................... 250
cUrea/BUN F
traceability........................................288 FCOHb

996-686C 389
Index ABL90 FLEX PLUS: Instructions for use

performance test results..................... 242 analyzer............................................... 1

traceability - 100 %........................... 287 interference
traceability - normal value...................287 electrolytes....................................... 257
feedback messages................................... 10 HbF/HbA...........................................351
FHbF metabolites....................................... 260
performance test results..................... 245 oximetry parameters.......................... 275
limitation of use.................................... 2 pH/blood gas.....................................257
traceability........................................287 tests................................................ 256
FHHb intervention required mode
performance test results..................... 244 to get out of........................................91
filtering
QC results.......................................... 81
activities...........................................136 K
calibration results................................ 88
keyboard
patient results..................................... 30
connect non-USB external keyboard....... 55
fluid transport system
connect USB keyboard..........................55
disinfect............................................. 54
keyboard layout...................................... 153
flush.................................................. 93
overview...........................................322
FMetHb
performance test results..................... 243 L
traceability........................................287 language
FO2Hb change............................................. 153
performance test results..................... 241 default setting................................... 206
latest patient result
find....................................................28
limitations of use........................................ 2
G
linearity checks
glossary
age-correct QUALICHECK7+ control
QC terms.......................................... 176 ranges............................................... 76
guided troubleshooting temperatue-correct QUALICHECK7+ control
about................................................. 91 ranges............................................... 75
linearity results......................................... 76
liquid sensor adjustment
H request.............................................. 96
hazards..................................................... 3 LIS/HIS connection
HbF corrections set up.............................................. 198
enable.............................................. 170 live connect............................................ 197
log
all measurement activities...................154
log on......................................................13
I logoff time
icons set................................................... 148
explanations......................................373 logon
inlet gasket select logon procedure........................144
clean..................................................52 long-term shutdown
inlet gasket holder to do................................................ 138
replace...............................................46 when to do........................................137
inlet module
replace...............................................44
input parameters
acceptable values...............................291
M
defaults............................................ 293 mandatory and operator-defined activities
definitions.........................................291 about............................................... 193
intended use manual flush............................................ 96
max sample age......................................162

390 996-686C
ABL90 FLEX PLUS: Instructions for use Index

maximum sample age edit standard texts............................. 196

set................................................... 162
measured parameters
defaults............................................ 293 O
definitions.........................................215
offset
measurement activities
limits for offset value..........................172
log all...............................................154
operator action needed mode
measurement mode
get out of........................................... 91
remove.............................................156
operator activities
select a default.................................. 156
delete...............................................195
measurement principle.............................340
operator activity
measurement principles
set up.............................................. 195
potentiometric................................... 329
operator requirements................................. 2
urea/BUN sensor................................345
operators
measurement process.............................. 323
add.................................................. 146
measurement units
default............................................. 146
default settings..................................209
remove.............................................147
measurements and tests
operators and profiles
total number of..................................151
default settings..................................205
measuring principles
optical system
general introduction........................... 321
calibration.........................................351
menu structure......................................... 15
construction...................................... 347
messages
measuring principle............................ 347
ampoule-based QC results.................... 69
ordering information
calibration results................................ 88
power-supply cords............................ 381
patient results..................................... 30
sensor cassette..................................377
shown on the analyzer screen..............150
solution pack.....................................377
types................................................. 10
spare parts and accessories.................378
metabolite derived parameters.................. 297
other activities
metabolite results
schedule........................................... 193
calculation........................................ 339
set up corrective action.......................194
metabolite sensors
out-of-range results
calculation of sensitivity...............339, 342
suppress...........................................169
construction............................... 338, 341
oximetry results
measuring principle.....................340, 344
calculation........................................ 353
zero current............................... 338, 342
miscellaneous setup
default settings..................................212
mode P
set up ampoule QC.............................157 parameter
set up calibration verification............... 157 enable/disable................................... 168
mouse remove from a patient result................. 32
connect non-USB mouse.......................55 symbols............................................291
connect USB mouse............................. 55 types................................................291
my results parameter bar
find....................................................28 hide................................................. 168
show................................................ 168
parameter tab colors................................... 8
parameters
N
default settings..................................208
network
edit offset/slope.................................173
connect analyzer to..............................56
input for derived electrolyte.................297
note fields
lock/unlock....................................... 150
create standard texts......................... 196
repress.............................................169
delete standard texts..........................196
set up measurement units...................169

996-686C 391
Index ABL90 FLEX PLUS: Instructions for use

suppress out-of-range results.............. 169 traceability........................................285

patents.................................................. 383 pCO2 results
patient data calculation........................................ 335
automatic requests............................ 199 fix decimals in................................... 169
from LIS/HIS or AQURE/RADIANCE pCO2 sensor
systems............................................198 calculation of sensitivity...................... 334
request automatically from LIS/HIS calibration.........................................334
system............................................... 27 construction...................................... 332
request using patient lookup).............. 199 performance characteristics
request via patient lookup.....................28 bias................................................. 217
patient identification coefficient of variation........................ 218
change report layout in.........................27 confidence intervals............................219
edit data after measurement................. 28 overview...........................................216
screen................................................27 repeatability......................................218
patient lookup reproducibility................................... 218
enable.............................................. 199 test conditions................................... 219
patient profile total analytical error........................... 219
add.................................................. 149 uncertainty....................................... 216
delete...............................................149 performance test results
edit..................................................149 cBUN................................................251
find.................................................. 149 cCa2+.............................................. 229
see data saved.................................. 149 cCl–................................................. 227
patient profiles log...................................149 cCrea............................................... 251
patient report layout cGlu................................................. 230
edit.................................................. 166 cK+................................................. 226
patient report layouts cLac................................................. 236
about............................................... 162 cNa+................................................227
create.............................................. 163 ctBil................................................. 246
create extra items for layouts.............. 165 ctHb.................................................239
select default.....................................165 cUrea............................................... 250
patient results FCOHb..............................................242
acid-base chart................................... 30 FHHb................................................244
add a note.......................................... 31 FMetHb.............................................243
approval and rejection...................32, 168 FO2Hb..............................................241
approve..............................................32 pCO2............................................... 223
audit trail........................................... 31 pH................................................... 222
change a layout for............................ 164 pO2................................................. 224
enable approval/rejection....................168 rounding rules................................... 222
filter data........................................... 30 sO2..................................................240
find....................................................28 pH
reject................................................. 33 performance characteristics.................222
remove a parameter............................ 32 traceability........................................285
see messages..................................... 30 pH results
show a parameter................................32 calculation........................................ 331
symbols............................................. 28 pH sensor
trends................................................ 31 calculation of sensitivity...................... 331
patient results log construction...................................... 328
status................................................ 30 measuring principle............................ 329
patient samples status and sensitivity calibrations......... 331
storage recommendations..................... 19 pH, pO2 and pCO2 results
patient/sample mix-up temperature correct............................. 78
reduce risk.................................. 20, 161 pO2
pCO2 calibration overview........................... 336
measuring principle............................ 333 measuring principle............................ 335
performance test results..................... 223 performance test results..................... 224

392 996-686C
ABL90 FLEX PLUS: Instructions for use Index

traceability........................................285 QC solutions
pO2 results about registration.............................. 177
calculation........................................ 337 ampoule-based QC.............................. 62
fix decimals in................................... 169 analyze in other modes........................ 82
power-supply cords data saved for registered non-Radio-
product codes....................................381 meter...............................................179
precision data saved in registered Radiometer.....178
within ranges.................................... 359 enable use of fixed standard deviations.191
printed data why is registration necessary?............. 177
create a heading................................ 152 QC statistics
printer automatically print when lot numbers
edit name......................................... 200 change............................................. 185
install............................................... 200 find....................................................79
printer paper print.................................................. 79
protection of printed data..................... 44 set statistical factor............................ 185
replace...............................................43 QC terms............................................... 176
printer setup QUALICHECK Opener/Adapter
default settings..................................213 clean..................................................53
product codes Qualicheck7+..........................................252
sampling devices............................... 379 QUALICHECK7+ control ranges
product specifications...............................363 age-correct......................................... 76
pump calibration temperature-correct.............................75
request.............................................. 96 quality control
management.......................................57
terms............................................... 176

Q
QC ID data
edit....................................................68
R
QC management RADIANCE connection
automatic........................................... 57 set up.............................................. 198
by operators....................................... 62 Radiometer QC ampoule
QC measurement prepare for use................................... 63
edit schedule for ampoule-based.......... 180 range
QC measurements of indication...................................... 161
after replacement.............................. 183 ranges and critical limits
edit schedule for built-in..................... 181 about..........................................29, 158
schedule ampoule-based.....................180 reference
set up the temperature field................ 179 getting to know the analyzer............. 3, 56
status................................................ 57 reference electrode
status symbols.................................... 57 construction...................................... 328
QC plot purpose............................................ 327
find....................................................80 reference methods/materials.................... 220
QC plots...................................................80 reference ranges
QC products about............................................... 159
ordering information...........................378 set up.............................................. 160
product codes....................................378 references
QC results introduction.................................... 3, 56
filter.................................................. 81 patient sample analysis chapter............. 34
QC schedule performance characteristics chapter..... 288
link to the calibration schedule.............176 principles of operation chapter............. 355
QC solution setup chapter.................................... 214
manually change control ranges...........192 regional settings
register a non-Radiometer...................179 select............................................... 153
register a Radiometer......................... 177 repeatability........................................... 218
replacement intervals

996-686C 393
Index ABL90 FLEX PLUS: Instructions for use

recommended..................................... 38 screen saver

replacement setups enable.............................................. 152
default settings..................................211 sensitivity
replacement warnings definition.......................................... 325
set up.............................................. 196 sensor
report layout general construction........................... 321
edit..................................................166 sensor cassette
reportable ranges can it be used again?........................... 42
about............................................... 160 effect of replacement on analysis time.... 42
set up.............................................. 160 export status logs................................ 43
reproducibility......................................... 218 print status logs.................................. 43
restart product codes....................................377
after a temporary shutdown................ 140 replace...............................................41
after long-term shutdown................... 140 specifications.....................................370
restoring data status of.............................................41
from backup......................................203 use of...............................................370
to Radiometer default settings............. 204 sensor response stability
result messages creatinine sensors.............................. 344
troubleshoot............................ 30, 70, 88 glu and lac sensors............................ 339
RiLiBÄK rules pCO2 sensor.............................. 332, 335
add.................................................. 188 pH and electrolytes sensor........... 332, 335
apply................................................189 urea/BUN sensor................................347
edit..................................................189 service...................................................136
remove.............................................190 setup
rinse load................................................. 204
process.............................................324 menu structure..................................143
request.............................................. 96 print setups.......................................144
restore Radiometer default settings...... 204
save.................................................204
S setups
sample with no default setting........................ 214
mix on analyzer...................................19 shutdown
pre-register........................................ 21 do a long-term.................................. 138
pre-registration............................ 20, 161 temporary.........................................137
to get a good...................................... 19 slope
what is a good sample..........................18 limits for slope value.......................... 172
sample age evaluation slope and offset
about............................................... 161 apply corrections to QC results............ 184
sample analysis sO2
capillary tube...................................... 23 performance test results..................... 240
syringes............................................. 22 sO2 = 0%
test tube............................................ 25 traceability........................................287
sample counter sO2 = 100 %
reset................................................ 151 traceablity........................................ 287
screen explanation............................. 151 software version......................................136
see.................................................. 151 solution pack
sample pre-registration can it be used again?........................... 40
interpret barcodes as..........................161 export status logs................................ 41
set up.............................................. 161 print status logs.................................. 41
sample type............................................298 product codes....................................377
sampling device replace...............................................39
ordering information...........................379 specifications.....................................368
product codes....................................379 status of.............................................38
recommended................................... 379 use of...............................................368
saving changes......................................... 14 specifications

394 996-686C
ABL90 FLEX PLUS: Instructions for use Index

environmental................................... 366 troubleshooting modes

measured blood parameters................ 357 causes............................................... 91
power-supply cords............................ 367 troubleshooting needed mode
product............................................ 363 get out of........................................... 91
start screen tubing refill
about................................................. 10 request.............................................. 96
access................................................13
quick access....................................... 10
statistical factor...................................... 185 U
status
uncertainty
definition.......................................... 327
convert to another confidence level...... 217
storing the analyzer................................. 139
performance characteristics.................216
symbols
units
ampoule-based QC results.................... 69
set up.............................................. 169
built-in QC results................................61
urea/BUN results
explanation....................................... 373
calculation................................. 343, 346
on calibration-verification results........... 74
urea/BUN sensor..................................... 344
syringe modes
user-defined corrections
create new........................................155
apply to QC results.............................184
edit.................................................. 154
edit..................................................173
select a specific report layout.............. 156
offset and slope................................. 170
system checks.......................................... 58
user-defined patient data items
system messages
default settings..................................211
set up corrective actions..................... 151

T W
temperature
warnings
automatically change unit................... 166
definition..............................................3
temperature correct
general.............................................. 17
pH, pO2 and pCO2 results.....................78
WDC
temporary shutdown
about................................................. 81
to do................................................ 137
export file...........................................81
when to do........................................137
Westgard rules
test conditions........................................ 219
description and corrective action.......... 186
text
disable/enable................................... 188
enter................................................. 13
line descriptions.................................185
tHb calibration
set up and enable.............................. 187
do..................................................... 85
types................................................185
thousands separator................................ 153
time and data formats..............................153
time and date
set................................................... 152
total analytical error................................ 219
touch screen
clean..................................................52
disinfect............................................. 53
trends
calibration results................................ 89
in patient results................................. 31
QC results.......................................... 81
troubleshoot
messages in the Analyzer status
screen.......................................... 11, 92
troubleshooting
when is it necessary?........................... 91

996-686C 395
Index ABL90 FLEX PLUS: Instructions for use

396 996-686C
 If you have any questions or need assistance, please contact your local Radiometer representa-
tive.

Radiometer representative:

Code number: 996-686

Version: 202102C

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