ABL90 FLEX reference manual

ABL90 FLEX
reference
manual
 Reference manual
Note to the operators of the ABL90 FLEX analyzer

Introduction This note outlines the improvements in software version 2.8.

Instructions to Put the Note to the operators in the binder of your manual and replace the
operators corresponding old front and date of issue pages with the new pages in this update kit.

Brief overview Improvements/Description

of the
Improvements Operator-defined offset You can now enter an operator-defined offset correction for
corrections for ctHb ctHb.
For instructions on how to enter operator-defined offset
corrections, see Parameter setup in section Parameters and
input setup in chapter 1 in the ABL90 FLEX reference manual.

Impact of low pO2 CAUTION – Risk of incorrect results

levels on Glucose
Low pO2 levels can influence the linearity of glucose
measurements, and can therefore result in falsely low
glucose results. Please note that glucose performance
is not specified when the pO2 is less than 25 mmHg
(3.33 kPa).
The linearity of the glucose is dependent on the oxygen
tension of the sample. This dependence is due to the co-
reaction of glucose and oxygen by the enzyme glucose
oxidase. Low pO2 levels can influence the linearity of the
glucose sensor. The following table outlines the glucose
linearity as a function of the pO2.

Impact of the pO2 level on Glucose linearity and

specifications of the ABL90 FLEX analyzer

If the pO2 level in a sample Then cGlu linearity

is: specifications only apply to
cGlu values between:

<25 mmHg (3.33 kPa) Linearity not specified.

Glu is not usable.
>25 mmHg (3.33 kPa) and 0-40 mmol/L
<90 mmHg (12 kPa)
≥90 mmHg (12 kPa) 0-40 mmol/L

If pO2<25 mmHg, the cGlu value is not usable and no value

is shown. Analyzer message no. 1387 informs you that the
cGlu value is not usable.

©2012 Radiometer Medical ApS. All Rights Reserved. 995-425. 201207A.

New performance test results for cGlu.
BiasPrim.ref and Repeatability – blood samples

Blood, pO2>90 mmHg

cGlu BiasPrim.ref S0 SX CVX% TEA TEA (%)
(mmol/L)
0.3 0.03 0.01 0.08 26.7 0.20 65.6
2.0 -0.09 0.02 0.09 4.5 0.27 13.3
6.0 -0.07 0.06 0.16 2.7 0.38 6.4
10.0 0.23 0.09 0.24 2.4 0.70 7.0
25.0 -0.87 0.18 0.83 3.3 2.5 10.0
40 -1.58 0.52 2.33 5.8 6.2 15.4

Blood, 25 mmHg < pO2 < 90 mmHg

cGlu BiasPrim.ref S0 SX CVX% TEA TEA (%)
(mmol/L)
0.3 -0.04 0.01 0.11 36.7 0.26 86.17
2.0 0.14 0.01 0.10 5.0 0.33 16.34
6.0 0.22 0.05 0.22 3.7 0.66 10.95
10.0 0.27 0.10 0.41 4.1 1.1 10.84
25.0 -0.35 0.25 1.38 5.5 3.1 12.43
40 -2.63 0.74 3.15 7.9 8.9 22.35

Serum pool, pO2>90 mmHg

cGlu BiasPrim.ref S0 SX CVX% TEA TEA (%)
(mmol/L)
0.3 -0.04 0.01 0.06 20 0.17 55.51
2.0 0.14 0.02 0.09 4.5 0.32 16.11
6.0 0.22 0.03 0.21 3.5 0.63 10.51
10.0 0.27 0.04 0.35 3.5 0.98 9.76
25.0 0.68 0.18 0.82 3.3 2.3 9.28
40 0.53 0.59 1.61 4.0 3.7 9.37
Analyzer messages These messages are new or changed:
No. Message Interpretation Operator action
1230 Inlet Gasket Holder Shown in the activity log − No action required.
replaced at the time of a
replacement.
1232 Inlet Connector Gasket Shown in the activity log − No action required.
replaced at the time of a
replacement.
1234 Demonstration software Demonstration software - − No action required.
- not for clinical not for clinical purposes
purposes
1362 Inlet gasket cleaning Guided troubleshooting − No action required
has been started step has been started by
operator
1363 Inlet gasket cleaning Guided troubleshooting − No action required
has been skipped step has been skipped by
operator
1364 Inlet gasket cleaning Test after action by − No action required
test ok operator is ok
1365 Inlet gasket cleaning Test after action by − No action required
test failed operator has failed
1366 Inlet gasket holder Guided troubleshooting − No action required
replacement has been step has been started by
started operator
1367 Inlet gasket holder Guided troubleshooting − No action required
replacement has been step has been skipped by
skipped operator
1369 Inlet gasket holder Test after action by − No action required
replacement test failed operator has failed
1371 Solution pack Guided troubleshooting − No action required
replacement skipped step has been skipped by
operator
1372 Solution pack Test after action by − No action required
replacement test ok operator is ok
1373 Solution pack Test after action by − No action required
replacement test failed operator has failed
1374 Inlet connector gasket Guided troubleshooting − No action required
replacement started step has been started by
operator
1375 Inlet connector gasket Guided troubleshooting − No action required
replacement skipped step has been skipped by
operator
1376 Inlet connector gasket Test after action by − No action required
replacement test ok operator is ok
1377 Inlet connector gasket Test after action by − No action required
replacement test failed operator has failed
1378 Inlet gasket holder Test after action by − No action required
replacement test ok operator is ok
1379 Solution pack Guided troubleshooting − No action required
replacement started step has been started by
operator
1380 Manual flush started Guided troubleshooting − No action required
step has been started by
operator
1381 Manual flush skipped Guided troubleshooting − No action required
step has been skipped by
operator
1382 Manual flush test ok Test after manual flush is − No action required
ok
1383 Manual flush test failed Test after manual flush − No action required
has failed
1384 Replace inlet gasket The inlet gasket holder − Replace inlet
holder needs to be replaced. gasket holder
 1386 System time adjusted No action − No action
more than 2 hours
1387 Glu not usable pO2 too low for reliable N/A
cGlucose measurement

The contents of this document will be added to the manual the next time the manual is
updated.

Radiometer Medical ApS

Åkandevej 21
2700 Brønshøj
Denmark
www.radiometer.com
 Table of contents

ABL90 FLEX 1. Setup

2. Disk functions setup programs

3. Wet section

4. Electronics

5. Sensors and measuring technologies

6. User-defined corrections

Reference 7. Performance characteristics

manual
From software version 2.8xx 8. Parameters

9. Solutions

10. Analyzer messages

I Appendix – Quality control

II Appendix – Traceability to primary

standards at Radiometer

Index

Date of issue
 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

The ABL90 FLEX analyzer comprises the Microsoft® Windows®XP Embedded and Sybase® SQL
Anywhere® software.
By using the system, you accept the terms of the Software License Agreement(s) of the provider(s)
of the above software as shown in the End User License Agreement(s) included in the operator's
manual. If you cannot accept the terms of the Software License Agreement(s), you should not use
the system, but immediately contact your provider for a return of the system and a refund of the
purchase price.
Microsoft® and Windows® are trademarks of Microsoft Corporation. Sybase® SQL Anywhere® is a
trademark of Sybase 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.
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 dama-
ges, 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 and you are urged to contact Radiometer to verify
whether the document has been changed.
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.

Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, AQURE, PICO, CLINITUBES and QUALICHECK are trademarks of or
used under license by Radiometer Medical ApS.

©2012 Radiometer Medical ApS. All rights reserved.

ABL90 FLEX reference manual Contents

Contents

1. Setup ............................................................................................... 1-1

Setup menu structure ........................................................................ 1-3
Analyzer security .............................................................................. 1-4
General security .................................................................... 1-4
Operators and passwords ........................................................ 1-5
Access profiles....................................................................... 1-8
Analysis setup .................................................................................1-10
Setting up a new measuring mode ..........................................1-11
Selecting a parameter profile..................................................1-11
Disabled versus deselected parameter .....................................1-11
Editing name of button ..........................................................1-11
Selecting a default layout.......................................................1-12
Selecting sample type ...........................................................1-12
Selecting sex........................................................................1-12
Setting age group limits.........................................................1-13
Setting reference and critical limits for each parameter ..............1-14
Program ..............................................................................1-16
Creating a layout ..................................................................1-16
Editing a layout ....................................................................1-17
Patient ID layout...................................................................1-17
Default values ......................................................................1-18
Editing patient result layout....................................................1-19
Calibration schedule setup.................................................................1-22
Editing the settings ...............................................................1-22
Available calibration schedule options ......................................1-22
Quality control setup ........................................................................1-23
Reference ............................................................................1-32
Replacement setup...........................................................................1-35
Recommended replacement intervals .......................................1-36
Adding a user activity ............................................................1-37
Editing a user activity ............................................................1-38
Deleting a user activity ..........................................................1-38
Contents ABL90 FLEX reference manual

Parameters and input setup ...............................................................1-41

Analyzer settings .............................................................................1-47
Communications setup......................................................................1-52
Disk functions setup .........................................................................1-60
Printers ..........................................................................................1-63
Corrective actions ............................................................................1-65
Conditions and corrective actions ............................................1-65
Explanation of corrective actions .............................................1-66
Miscellaneous setup..........................................................................1-67
List of options ......................................................................1-67
Activating/ deactivating an option ...........................................1-68
Selecting HbF correction ........................................................1-68
Analyzer messages ...............................................................1-69
Setting the time for the screen saver to appear .........................1-69
Setup default settings.......................................................................1-70
Access to Radiometer default setup .........................................1-70
Operators and passwords .......................................................1-70
Analysis setup ......................................................................1-71
Calibration schedule ..............................................................1-72
Quality control setup .............................................................1-72
Replacement setup................................................................1-74
General setup.......................................................................1-74
Setups without Radiometer settings.........................................1-78
Print setup ......................................................................................1-79
Contents of setup settings .................................................................1-80
Groups of setup settings ........................................................1-80
Parameters group .................................................................1-80
General group ......................................................................1-81
Schedules, etc. .....................................................................1-82
Interfacing facilities ..........................................................................1-83
Connecting a mouse..............................................................1-83
Connecting an alpha-numeric keyboard....................................1-83
Connecting to a network ........................................................1-83
External barcode reader.........................................................1-84
Sample counter ...............................................................................1-85
2. Disk functions setup programs......................................................... 2-1
General information........................................................................... 2-2
Disk functions programs ......................................................... 2-2
Definitions ............................................................................ 2-2
Data storage options .............................................................. 2-2
Disk handling rules ................................................................ 2-2
ABL90 FLEX reference manual Contents

Creating a WDC report....................................................................... 2-3

Backing up all data............................................................................ 2-4
Restoring all data.............................................................................. 2-6
Exporting data logs ........................................................................... 2-7
Importing/exporting archives.............................................................. 2-8
Exporting an archive .............................................................. 2-8
Importing an archive .............................................................. 2-8
Deleting an archive ................................................................ 2-8
Saving setup .................................................................................... 2-9
Loading/restoring setup ....................................................................2-10
3. Wet section ...................................................................................... 3-1
Introduction ..................................................................................... 3-2
Definition.............................................................................. 3-2
Contents of wet section .......................................................... 3-2
Wet section diagram.......................................................................... 3-3
Measuring processes ......................................................................... 3-4
General information........................................................................... 3-4
Prior to measurement............................................................. 3-4
Heating ................................................................................ 3-4
Solutions .............................................................................. 3-4
Waste removal ...................................................................... 3-4
Patient samples ................................................................................ 3-5
Measuring process ................................................................. 3-5
Rinse process ................................................................................... 3-6
Calibration ....................................................................................... 3-7
pO2 calibration ...................................................................... 3-7
pCO2, cGlu, cLac calibration..................................................... 3-7
pH, cK+, cNa+, cCa2+, cCl– calibration........................................ 3-7
Oxi calibration ....................................................................... 3-7
Automatic QC ................................................................................... 3-8
Measuring process ................................................................. 3-8
Manual QC samples ........................................................................... 3-9
Measuring process ................................................................. 3-9
4. Electronics ....................................................................................... 4-1
General information........................................................................... 4-2
Communication ..................................................................... 4-2
Electronic boards and components....................................................... 4-3
Power supply......................................................................... 4-3
Sensor Module....................................................................... 4-3
Inlet positioning..................................................................... 4-3
User Interface Module ............................................................ 4-3
Contents ABL90 FLEX reference manual

Printer unit ........................................................................... 4-4

Sample mixer (for safePICO only) ............................................ 4-4
5. Sensors and measuring technologies ............................................... 5-1
General construction ......................................................................... 5-2
Sensors ................................................................................ 5-2
General measuring principles .............................................................. 5-3
Introduction .......................................................................... 5-3
Activity vs. concentration ........................................................ 5-3
Conversion of activity to concentration...................................... 5-3
Calibration ....................................................................................... 5-4
General information........................................................................... 5-5
Definition.............................................................................. 5-5
Frequency............................................................................. 5-5
Calibration solutions............................................................... 5-5
Traceability of calibration solutions ........................................... 5-5
The calibration equation..................................................................... 5-6
Definition.............................................................................. 5-6
Use...................................................................................... 5-6
Deriving the calibration line ..................................................... 5-6
Scale ................................................................................... 5-6
Sensitivity........................................................................................ 5-7
Definition.............................................................................. 5-7
Updating .............................................................................. 5-7
Sensitivity ............................................................................ 5-7
Status .................................................................................. 5-7
Drift..................................................................................... 5-7
Measurement ................................................................................... 5-8
Sample measurements ........................................................... 5-8
Corrections ........................................................................... 5-8
Quality Management.......................................................................... 5-9
Introduction .......................................................................... 5-9
System/ analysis checks ......................................................... 5-9
Calibration ...........................................................................5-12
Measurement .......................................................................5-12
Reference electrode..........................................................................5-13
Background information about the reference electrode ..........................5-14
Fixed potential......................................................................5-14
Use.....................................................................................5-14
Construction of the reference electrode ...............................................5-15
Parts and functions ...............................................................5-15
ABL90 FLEX reference manual Contents

pH and electrolyte sensors ................................................................5-16

Construction of the pH and electrolyte sensors .....................................5-17
Parts and description .............................................................5-17
Measuring principle of the pH and electrolyte sensors ............................5-18
Potentiometric measuring principle ..........................................5-18
Electrode chain.....................................................................5-18
Parts and description .............................................................5-18
Electrode chain potential ........................................................5-18
Unknown potential ................................................................5-19
Ion-sensitive membrane ........................................................5-19
Nernst equation ....................................................................5-19
Activity and concentration ......................................................5-19
Calibration of the pH and electrolyte sensors........................................5-20
Introduction .........................................................................5-20
2-point calibration.................................................................5-20
Calibration levels ..................................................................5-20
Calibration ...........................................................................5-20
Measurement – pH and electrolytes ....................................................5-21
Measurement .......................................................................5-21
Checks ................................................................................5-21
pCO2 sensor ....................................................................................5-22
Construction of the pCO2 sensor.........................................................5-23
Parts and description .............................................................5-23
Measuring principle of the pCO2 sensor ...............................................5-24
Electrode chain.....................................................................5-24
Parts and description .............................................................5-24
Electrode chain potential ........................................................5-24
Measuring process ................................................................5-25
Calibration of the pCO2 sensor ...........................................................5-26
Introduction .........................................................................5-26
Calibration levels ..................................................................5-26
Sensitivity ...........................................................................5-26
Measurement – pCO2 ........................................................................5-27
Measurement .......................................................................5-27
Checks ................................................................................5-27
pO2 sensor ......................................................................................5-28
Measuring principle of the pO2 sensor .................................................5-29
Optical system for pO2 ...........................................................5-29
Measuring sequence ..............................................................5-29
Calculations .........................................................................5-29
Contents ABL90 FLEX reference manual

Calibration of the pO2 sensor .............................................................5-30

Introduction .........................................................................5-30
Sensitivity ...........................................................................5-30
Status .................................................................................5-30
Measurement - pO2 ..........................................................................5-31
Checks ................................................................................5-31
Metabolite sensors ...........................................................................5-32
Construction of the metabolite sensors................................................5-33
Basic description...................................................................5-33
Parts and description .............................................................5-33
Zero current.........................................................................5-33
Calibration of the metabolite sensors ..................................................5-34
Sensitivity ...........................................................................5-34
Measurement – metabolites...............................................................5-35
Measurement .......................................................................5-35
Checks ................................................................................5-35
Measuring principle of the metabolite sensors ......................................5-36
Amperometric measuring principle ..........................................5-36
Electrode chain.....................................................................5-36
Parts and functions ...............................................................5-36
Measuring process ................................................................5-37
ctHb and derivates ...........................................................................5-38
General information..........................................................................5-39
Measured parameters ............................................................5-39
Construction ........................................................................5-39
Measurement cycle ...............................................................5-40
Lambert-Beer's law ...............................................................5-40
Absorbance ..........................................................................5-41
Total absorbance ..................................................................5-41
Continuous spectrum.............................................................5-41
Spectrum examples...............................................................5-42
Determining concentrations....................................................5-42
Matrix of constants ...............................................................5-43
Calibration of the optical system ........................................................5-44
Calibration materials .............................................................5-44
Zero point............................................................................5-44
Cuvette path length ..............................................................5-44
tHb calibration frequency .......................................................5-44
ABL90 FLEX reference manual Contents

Correcting for interferences ...............................................................5-45

HbF versus HbA ....................................................................5-45
Deviation of results ...............................................................5-45
Detecting HbF ......................................................................5-45
Correcting for HbF.................................................................5-45
Repressing spectra................................................................5-45
Residual spectrum ................................................................5-46
Measurement and corrections ............................................................5-47
Oximetry parameters ............................................................5-47
Bilirubin ..............................................................................5-47
Restrictions..........................................................................5-48
Corrections for ctHb ..............................................................5-49
Corrections for ctBil...............................................................5-49
References ......................................................................................5-50
6. User-defined corrections .................................................................. 6-1
General information........................................................................... 6-2
Purpose of use....................................................................... 6-2
User-defined corrections ......................................................... 6-2
Preparatory action ................................................................. 6-2
Entering user-defined corrections ............................................. 6-3
Correction factors for pH and blood gases ............................................. 6-4
Correcting slope and offset...................................................... 6-4
Correction factors for oximetry parameters ........................................... 6-5
Allowed corrections ................................................................ 6-5
ctHb .................................................................................... 6-5
sO2 ...................................................................................... 6-5
FCOHb ................................................................................. 6-6
FMetHb ................................................................................ 6-6
FHbF .................................................................................... 6-6
FO2Hb and FHHb.................................................................... 6-6
ctBil ..................................................................................... 6-7
Correction factors for electrolyte and metabolite parameters ................... 6-8
Correcting slope and offset...................................................... 6-8
Resetting corrections to default values ...................................... 6-8
7. Performance characteristics............................................................. 7-1
General information........................................................................... 7-2
Definition of terms ............................................................................ 7-3
Bias ..................................................................................... 7-3
Reference methods ................................................................ 7-3
Coefficient of variation (CV%).................................................. 7-5
Confidence intervals ............................................................... 7-5
Contents ABL90 FLEX reference manual

Repeatability/Reproducibility ................................................... 7-5

Total analytical error .............................................................. 7-5
Test conditions ................................................................................. 7-6
Performance test results – chart description.......................................... 7-7
Modes .................................................................................. 7-7
Number of measurements ....................................................... 7-7
Performance test results – pH ............................................................. 7-8
Reference method.................................................................. 7-8
BiasPrim.ref .............................................................................. 7-8
BiasSec.ref and Repeatability – blood samples............................... 7-8
Performance test results – pCO2 .......................................................... 7-8
Reference method.................................................................. 7-8
BiasPrim.ref and Repeatability – blood samples.............................. 7-8
Performance test results – pO2 ............................................................ 7-9
Reference method.................................................................. 7-9
BiasPrim.ref and Repeatability – blood samples.............................. 7-9
Performance test results – cK+ ............................................................ 7-9
Reference method.................................................................. 7-9
BiasPrim.ref .............................................................................. 7-9
BiasSec.ref and Repeatability – blood samples............................... 7-9
Performance test results – cNa+ .........................................................7-10
Reference method.................................................................7-10
BiasPrim.ref and Repeatability – blood samples.............................7-10
Performance test results – cCl– ..........................................................7-10
Reference method.................................................................7-10
BiasPrim.ref .............................................................................7-10
BiasSec.ref and Repeatability – blood samples............................7-10
Performance test results – cCa2+ ........................................................7-11
Reference method.................................................................7-11
BiasPrim.ref .............................................................................7-11
BiasSec.ref and Repeatability – blood samples..............................7-11
Performance test results – cGlu..........................................................7-11
Reference method.................................................................7-11
BiasPrim.ref and Repeatability – blood samples.............................7-11
Performance test results – cLac..........................................................7-12
Reference method.................................................................7-12
BiasPrim.ref and Repeatability – blood samples.............................7-12
Performance test results – ctHb .........................................................7-13
Reference method.................................................................7-13
BiasPrim.ref and Repeatability – blood samples.............................7-13

Performance test results – sO2 ...........................................................7-14

ABL90 FLEX reference manual Contents

Reference method.................................................................7-14
BiasPrim.ref .............................................................................7-14
BiasSec.ref and Repeatability – blood samples..............................7-14
Performance test results – FO2Hb .......................................................7-15
Reference method.................................................................7-15
BiasSec.ref and Repeatability – blood samples..............................7-15
Performance test results – FCOHb ......................................................7-15
Reference method.................................................................7-15
BiasPrim.ref .............................................................................7-15
BiasSec.ref and Repeatability – blood samples..............................7-16
Performance test results – FMetHb .....................................................7-16
Reference method.................................................................7-16
BiasPrim.ref .............................................................................7-16
BiasSec.ref and Repeatability – blood samples..............................7-16
Performance test results – FHHb ........................................................7-17
Reference method.................................................................7-17
BiasSec.ref and Repeatability – blood samples..............................7-17
Performance test results – FHbF .........................................................7-17
Reference method.................................................................7-17
BiasPrim.ref and Repeatability – blood samples.............................7-17
Performance test results – bilirubin.....................................................7-18
Reference method.................................................................7-18
BiasPrim.ref .............................................................................7-18
BiasSec.ref ..............................................................................7-18
External test results ..............................................................7-18
Interference tests ............................................................................7-20
pH/blood gas........................................................................7-20
Electrolytes ..........................................................................7-21
Metabolites ..........................................................................7-23
Oximetry parameters ............................................................7-25
FHbF sensitivity for pH changes ..............................................7-26
ctBil sensitivity for MCHC variations.........................................7-26
Anticoagulants (sampling)......................................................7-28
List of references ..................................................................7-29
8. Parameters ...................................................................................... 8-1
General information........................................................................... 8-2
The Deep Picture ................................................................... 8-2
Symbols ............................................................................... 8-3
Ranges and limits .................................................................. 8-4
Derived parameters................................................................ 8-4
Measured parameters ............................................................. 8-5
Contents ABL90 FLEX reference manual

Sample type.......................................................................... 8-5

Units.................................................................................... 8-5
Default values ....................................................................... 8-5
Measured parameters ........................................................................ 8-6
General information ............................................................... 8-6
pH ....................................................................................... 8-6
cH+ ...................................................................................... 8-6
pCO2 .................................................................................... 8-6
pO2 ...................................................................................... 8-7
Baro .................................................................................... 8-7
ctHb .................................................................................... 8-7
sO2 ...................................................................................... 8-8
FO2Hb .................................................................................. 8-8
FCOHb ................................................................................. 8-8
FMetHb ................................................................................ 8-8
FHHb ................................................................................... 8-9
FHbF .................................................................................... 8-9
cK+ ...................................................................................... 8-9
cNa+ .................................................................................... 8-9
cCa2+ ................................................................................... 8-9
cCl- .....................................................................................8-10
cGlu....................................................................................8-10
cLac....................................................................................8-10
ctBil ....................................................................................8-10
Input parameters .............................................................................8-13
Definition.............................................................................8-13
T ........................................................................................8-13
FO2(I) .................................................................................8-13
ctHb ...................................................................................8-13
RQ......................................................................................8-13
–
pO2(v ) ................................................................................8-13
–
sO2(v ).................................................................................8-14
·
Q t ......................................................................................8-14
·
VO2 .....................................................................................8-14
VCO ....................................................................................8-14
FCOHb(1) ............................................................................8-14
FCOHb(2) ............................................................................8-14
ABL90 FLEX reference manual Contents

Derived parameters..........................................................................8-15
General information ..............................................................8-15
Acid-base derived parameters.................................................8-15
Oximetry derived parameters .................................................8-16
Oxygen derived parameters....................................................8-16
Units and numerical format of derived parameters ................................8-19
Calculated versus estimated parameters ..................................8-19
Electrolyte parameters...........................................................8-19
Possible ranges and precision (number of decimals) ...................8-20
List of equations ..............................................................................8-23
Units and symbols.................................................................8-23
pH(T) ..................................................................................8-23
cH+(T).................................................................................8-23
pCO2(T)...............................................................................8-23
cHCO3–(P)............................................................................8-23
cBase(B) .............................................................................8-24
cBase(B,ox) .........................................................................8-24
cBase(Ecf) ...........................................................................8-24
cBase(Ecf,ox) .......................................................................8-24
cHCO3–(P,st) ........................................................................8-24
ctCO2(P) ..............................................................................8-24
ctCO2(B)..............................................................................8-25
pH(st) .................................................................................8-25
Hct .....................................................................................8-25
pO2(T).................................................................................8-25
pO2(A) ................................................................................8-26
pO2(A,T)..............................................................................8-26
pO2(a)/FO2(I) .......................................................................8-26
pO2(a,T)/ FO2(I) ...................................................................8-27
p50.....................................................................................8-27
p50(T) ................................................................................8-27
p50(st)................................................................................8-28
pO2(A-a)..............................................................................8-28
pO2(A-a,T) ...........................................................................8-28
pO2(a/A)..............................................................................8-28
pO2(a/A,T) ...........................................................................8-28
(or px).................................................................................8-29
ctO2 ....................................................................................8-29
–
ctO2(av ) ............................................................................8-29
BO2.....................................................................................8-29
ctO2(x) (or cx) ......................................................................8-30
Contents ABL90 FLEX reference manual

·
D O2 ....................................................................................8-30
·
Q t ......................................................................................8-30
·
VO2 .....................................................................................8-30
FShunt ................................................................................8-31
FShunt(T) ............................................................................8-32
RI.......................................................................................8-32
RI(T)...................................................................................8-32
Qx.......................................................................................8-33
sO2 .....................................................................................8-33
FO2Hb .................................................................................8-33
FHHb ..................................................................................8-34
V(B)....................................................................................8-34
Anion Gap,K+ .......................................................................8-34
Anion Gap............................................................................8-34
cCa2+(7.4) ...........................................................................8-34
mOsm .................................................................................8-34
FHbF ...................................................................................8-34
pO2(x,T) ..............................................................................8-35
VCO2/V(dry air) ....................................................................8-36
VO2/V(dry air) ......................................................................8-36
Oxyhemoglobin dissociation curve (ODC).............................................8-37
ODC equations .....................................................................8-37
The ODC reference position ....................................................8-37
The ODC displacement...........................................................8-38
The actual ODC position.........................................................8-39
Determining the actual displacement .......................................8-39
Coordinates on the ODC.........................................................8-41
Conversion of units ..........................................................................8-42
SI units ...............................................................................8-42
Temperature ........................................................................8-42
cK+, cNa+, cCl– .....................................................................8-42
cCa2+ ..................................................................................8-42
Pressure ..............................................................................8-42
ctHb ...................................................................................8-42
–
ctCO2, ctO2, ctO2(av ), BO2 ...................................................8-42
·
VO2 .....................................................................................8-42
cGlu....................................................................................8-43
cLac....................................................................................8-43
ctBil ....................................................................................8-43
ABL90 FLEX reference manual Contents

Default values .................................................................................8-44

Values.................................................................................8-44
References ......................................................................................8-45
9. Solutions .......................................................................................... 9-1
General information........................................................................... 9-2
Introduction .......................................................................... 9-2
Solution pack ........................................................................ 9-2
Lot ...................................................................................... 9-2
In vitro diagnostic use ............................................................ 9-2
Expiration date ...................................................................... 9-2
Storage ................................................................................ 9-2
Material safety Data Sheets..................................................... 9-2
Solutions ......................................................................................... 9-3
Use...................................................................................... 9-3
Pouch volume........................................................................ 9-3
Composition.......................................................................... 9-3
Certificate of traceability .................................................................... 9-5
10. Messages ....................................................................................... 10-1
List of analyzer messages..................................................................10-2
Messages on user and manager levels......................................10-2
I Appendix - Quality control............................................................... I-1
General information............................................................................ I-2
Statistical parameters......................................................................... I-3
Control ranges (for manual QC only)..................................................... I-4
About control ranges ............................................................... I-4
Definitions ............................................................................. I-4
User control ranges (for manual QC only) .............................................. I-6
Introduction ........................................................................... I-6
Establishing analyzer-specific control ranges ............................... I-6
Table 1: ................................................................................ I-7
Statistics factor and statistics range...................................................... I-9
Definitions ............................................................................. I-9
Example ................................................................................ I-9
Temperature corrections (for manual QC only) ..................................... I-10
Purpose ............................................................................... I-10
Parameters that require temperature correction ........................ I-10
Temperature corrections for pH, pCO2 and pO2 .......................... I-11
Westgard rules ................................................................................ I-12
About Westgard rules ............................................................ I-12
Plot lines ............................................................................. I-12
Rule 12s ............................................................................... I-13
Contents ABL90 FLEX reference manual

Rule 13s ............................................................................... I-13

Rule 22s ............................................................................... I-13
Rule R4s .............................................................................. I-14
41s ...................................................................................... I-14
Rule 10x .............................................................................. I-14
Quality control evaluation.................................................................. I-15
Evaluation procedure............................................................. I-15
II Appendix - Traceability to the primary standards at Radiometer ...II-1
Introduction ..................................................................................... II-2
Traceability ...................................................................................... II-3
pH ....................................................................................... II-3
pCO2 and pO2 ........................................................................ II-3
cK+ and cNa+ ........................................................................ II-3
cCa2+ ................................................................................... II-4
cCl– ..................................................................................... II-4
cGlu..................................................................................... II-4
cLac..................................................................................... II-4
ctHb .................................................................................... II-4
Saturation – sO2 = 100 %....................................................... II-5
Saturation – sO2 = 0 % .......................................................... II-5
FCOHb – normal value............................................................ II-5
FCOHb – 100 %.................................................................... II-5
FMetHb ................................................................................ II-5
FHbF .................................................................................... II-5
Hct ...................................................................................... II-5
ctBil ..................................................................................... II-6

Index
Date of issue
 1. Setup

Setup menu structure ...................................................................... 1-3

Analyzer security............................................................................. 1-4
Analysis setup................................................................................1-10
Syringe modes .............................................................................1-10
Reference ranges and critical limits..................................................1-12
Reportable ranges.........................................................................1-15
Patient report setup ......................................................................1-16
Sample pre-registration setup.........................................................1-20
Sample age evaluation setup ..........................................................1-21
Calibration schedule setup ...............................................................1-22
Quality control setup.......................................................................1-23
Manual quality control (QC) solutions ...............................................1-23
Quality control schedule setup ........................................................1-24
QC ranges....................................................................................1-26
QC input setup .............................................................................1-28
QC statistics.................................................................................1-29
Westgard Rules setup ....................................................................1-30
RiLiBÄK ranges .............................................................................1-32
Replacement setup .........................................................................1-35
Replacement schedule setup...........................................................1-35
User activities...............................................................................1-37
Maintenance planning ....................................................................1-39
Replacement warnings...................................................................1-40
Parameters and input setup .............................................................1-41
Parameter setup ...........................................................................1-41
Units setup ..................................................................................1-43
User-defined patient data items ......................................................1-44
User-defined notes ........................................................................1-46
Analyzer settings............................................................................1-47
Analyzer identification ...................................................................1-47
Time/date setup ...........................................................................1-48
Acoustic signal setup .....................................................................1-49
Barometer setup ...........................................................................1-50
Languages ...................................................................................1-51
Communications setup ....................................................................1-52
RADIANCE connection setup ...........................................................1-52
LIS/HIS connection setup...............................................................1-53
Automatic data transmission setup ..................................................1-55
1. Setup ABL90 FLEX reference manual

Automatic data request setup .........................................................1-57

Patient lookup setup......................................................................1-58
QA Portal connection setup.............................................................1-59
Disk functions setup........................................................................1-60
Automatic archiving setup ..............................................................1-60
Automatic backup setup.................................................................1-62
Printers.........................................................................................1-63
Printer setup ................................................................................1-63
Automatic printing ........................................................................1-64
Corrective actions...........................................................................1-65
Miscellaneous setup ........................................................................1-67
Setup default settings .....................................................................1-70
Print setup ....................................................................................1-78
Contents of setup settings ...............................................................1-79
Interfacing facilities ........................................................................1-82
Sample counter..............................................................................1-84

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ABL90 FLEX reference manual 1. Setup

Setup menu structure

Menu

Utilities

Setup

Analysis setup QC setup

Syringe modes QC solutions

Capillary modes QC schedule
Patient reports QC ranges
Reference ranges QC input setup
Sample age evaluation QC statistics
setup Westgard Rules
Reportable ranges RiLiBÄK ranges

Calibration schedule
Replacement setup

Replacement schedule Analyzer security

User activities General security
Maintenance planning
Operators and passwords
Replacement warnings Access profiles

Print analyzer setup General setup

Analyzer settings Communications

Analyzer ID
RADIANCE connection
Time/Date
LIS/HIS connection
Acoustic signal
Automatic data
Barometer
transmission
Language
Automatic data request
Patient lookup setup
Parameters and input QA Portal connection

Parameters
Units Printers
User-defined data items Printer setup
User-defined notes Automatic printing

Disk functions setup Corrective actions

Automatic archiving
Automatic backup Miscellaneous setup

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1. Setup ABL90 FLEX reference manual

Analyzer security

Programs The Analyzer security program allows you to do the following:

 Set up the general security (set automatic logoff time)
 Add/remove operators from the operator list
 Assign and define access profiles (assign an anonymous operator, i.e. allow
the use of the analyzer without a password, define access to menus for each
access profile, Select configuration of six buttons on the main screen)

General This program allows you to hand over the control of the operators and
security passwords to the RADIANCE system and to allow an anonymous use of the
analyzer and to define the logoff time of an operator.
To enter this program, press Menu > Utilities > Setup > Analyzer Security
> General Security.

To hand over the control of the operators and passwords to the RADIANCE
system, activate the check button next to "Enable centralized User
Management".
With this option enabled you can only view the operators, not add, edit or
remove any of them. All users defined on the ABL90 FLEX analyzer are deleted
and the list of users in the RADIANCE system is copied to the ABL90 FLEX
analyzer.
NOTICE: This option can only be enabled if RADIANCE communication is
enabled in the RADIANCE Connection Setup program.
To define, how the user should log on, use the up/down arrow buttons in the
"Authenticate" box to select the desired logon option. The following options are
available:
 User ID/Password as primary
This option allows you to enter or scan a User name and password in the
Logon screen. By pressing the Log On BC button a Logon-barcode can be
scanned.
 User ID/Password only
This option allows you to enter or scan the user name and password in the
Logon screen.
 Logon-barcode as primary
This option allows you to enter or scan a Logon-barcode in the Logon screen.
By pressing the Extended Log On button a user name and password can be
scanned.

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ABL90 FLEX reference manual 1. Setup

 Logon-barcode only
This option allows you to enter or scan a Logon-barcode in the Logon screen.
To allow an anonymous use of the analyzer, i.e. use without logon, use the
up/down arrow buttons to select "Yes" in the "Anonymous use" box (default)
and select the desired access profile of the anonymous operator, in the "Access
profile for anonymous operator" box. The "Access profile for anonymous
operator" box only appears, when "Yes" is chosen in the "Anonymous use" box.
See Access profiles further in this section for information on how to define the
access profiles.
To set the time interval to elapse, before an operator is automatically logged off,
press the Logoff time button. Select the logoff time in minutes (from 0 to 60)
and seconds (from 0 to 50 in 10-second intervals). The default logoff time is
three minutes. Press Back to return to the General Security screen.

Operators and This program allows you to add, edit or remove operators and to assign an
passwords access profile to each operator.
NOTICE: If the Centralized User Management option is enabled in the General
Security screen, you cannot add, remove or edit the operators, but only view
the access profiles of the individual operators.
To enter the Operators and Passwords program, press Menu > Utilities >
Setup > Analyzer Security > Operators and Passwords.

Shows the list of

actual operators

Shows the list of

available operator
profiles

When the analyzer is taken into use, the following default operators are
available:

Operator Has access to…

Manager All menu items and programs (not service programs). It
is recommended to remove this operator with the
standard password: 123456, and enter the actual users
with their profiles and passwords.
Radiometer All menu items and programs (user and service) on the
analyzer. Note that "Radiometer" cannot be removed
from the operator list.
Remote operator All menu items and programs (user and service) on the
analyzer, if this is given to the Remote operator.

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1. Setup ABL90 FLEX reference manual

To add an operator to the list, do the following:

Step Action
1. Press the Add Operator button to display the Add New Operator
screen.

2. Type the name of the operator or operator category in the "Operator

ID" box, using the screen keyboard.
3. Enter or scan the password: in the "Password" box.
The password must be at least four characters long, and not more
than 32.
4. Re-enter or re-scan the password in the "Confirm" box.
5. Enter or scan the logon barcode in the "Logon – barcode:" box
The password must be at least four characters long. The logon
barcode and the password can be identical.
6. Re-enter or re-scan the logon barcode in the "Confirm" box.
7. Press Back.
If the password is not accepted, the Add New Operator screen
remains open and a message, telling you what was wrong, appears.
If the password is accepted, the Operators and Passwords screen
is displayed.
8. In the Operators and Passwords screen, select the desired access
profile of the new operator.

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ABL90 FLEX reference manual 1. Setup

To edit the operator identifications of an operator, do the following:

Step Action
1. Press the Edit Operator button to display the Add New Operator
screen.

2. Touch and highlight the box to be changed. Enter the change. If you
change the passwords, confirm them again.
The password must be at least four characters long. The logon
barcode and the password can be identical.
3. Press Back.
If the password is not accepted, the Add New Operator screen
remains open and a message, telling you what was wrong, appears.
If the password is accepted, the Operators and Passwords screen
is displayed.
4. In the Operators and Passwords screen, select the desired access
profile of the new operator.

To remove an operator from the list, use the up/down arrow buttons in the
"Operator" box to highlight the operator and press Remove Operator.

NOTICE: If the Centralized User Management option is enabled in the General

Security screen you cannot add, remove or edit the operators, but only view the
access profiles of the individual operators.

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1. Setup ABL90 FLEX reference manual

Access profiles This program allows you to define the permitted actions, the available menu
items and button shortcuts of an access profile.
To enter this program, press Menu > Utilities > Setup > Analyzer
Security > Access Profiles.

To define the permitted actions of an access profile, select the desired profile in
the "Profile names" box and activate the desired check buttons in the "Permitted
actions" box.
To deactivate an action, press the check buttons once again.
To define the available menu items and button shortcuts of an access profile do
the following:

Step Action
1. In the Access Profiles screen highlight the desired access profile in
the "Profile names" box and press Menus and Buttons.
Note that this button is grayed-out for the service technician profile.
2. Select the desired menu items in the "Menu Items in Quick Menu"
box.

Selected profile
is named on the
screen.

A grayed-out item in the Menu & Button Configuration screen

indicates that only some sub items were selected in this group. Clear
checked items indicate that all sub items have been selected.

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ABL90 FLEX reference manual 1. Setup

The buttons allows you to do the following:

Highlight menu items

Open/close submenus

Select/deselect a menu item.

3. To create a button shortcut for a specific item, highlight the desired

item in the "Menu Items in Quick Menu" box and then, in the "Button
configuration" box, press the button position that you wish to give the
selected item.

4. Select other five buttons in the same manner, if desired.

5. To deselect a button, press it once again.
6. Press Back to return to the Access Profiles screen.

Enabling the “My Results” option will give the operator an easy access to all
Patient Results made by that operator, by displaying the Patient Result Log,
filtered on the operator name.

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1. Setup ABL90 FLEX reference manual

Analysis setup
Program Press Menu> Utilities > Setup > Analysis setup and activate a button to
enter a program.
The following programs are available:
 Syringe mode
 Capillary mode
 Patient reports
 Reference ranges
 Sample age evaluation setup
 Reportable ranges
 Sample pre-registration

Syringe/capillary modes

The Syringe modes setup screen is shown below:

The Capillary modes setup screen is shown below:

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ABL90 FLEX reference manual 1. Setup

Setting up a Step Action

new measuring
mode 1. Select an unoccupied button in the "Select button to set up" field on
the Syringe modes setup or Capillary modes setup screen.
2. Enable the button by activating the "Button is enabled" check
button.
3. Select the desired measuring program with the arrow buttons and
select the desired parameter profile (see Selecting a parameter
profile below).

Selecting a
parameter
profile

Step Action
1. Press Parameters on the Syringe modes setup or Capillary
modes setup screen.
2. Select parameters for a given measuring mode by activating a
parameter check button (see Screen elements in section Software,
chapter 2 in the ABL90 FLEX operator's manual).
3. Activate the check button in the "Use dynamic parameters" box to
select parameters during a sample measurement.

Disabled A parameter is disabled, i.e. excluded from the Parameter profile screen and
versus the parameter bar, in General setup > Parameters and input.
deselected
A parameter that has been deselected for the given syringe or capillary mode
parameter
will be measured, but excluded from the displayed and printed patient report.
You can further select or deselect a parameter before or after a measurement 
see chapter 4: Sample measurement in the ABL90 FLEX operator's manual.

Editing name Step Action

of button
1. Press Edit on the Syringe modes setup or Capillary modes
setup screen.
2. Enter the new name on the keyboard and confirm the entry with
Enter.
The screen returns to the Syringe modes setup or Capillary
modes setup screen.

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1. Setup ABL90 FLEX reference manual

Selecting a Step Action

default layout
1. Press Layout on one of the Modes setup screens.
2. Select the layout from the list (made in the Patient report setup –
see Patient report setup further in this section).
The selected layout will be the default layout for the given
measuring mode.
3. Press Back to confirm the settings.

Reference ranges and critical limits

In this program you can enter your own reference ranges and critical limits for
all measured and calculated parameters. For each parameter, you can choose
whether or not to differentiate between the categories of sample type, sex and
age group.

Selecting Step Action

sample type
1. Highlight a parameter in the "Parameter" box, using the up/down
arrows.
2. Press the check button in the "Sample type" box and select a
sample type, using the up/down arrows in the box.

NOTICE: Press the check button to activate a function; press the check button
again to deactivate it.

Selecting sex Step Action

1. Highlight a parameter.
2. Press the check button in the "Sex" box and select sex type, using
the up/down arrows in the box.

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ABL90 FLEX reference manual 1. Setup

Setting age
group limits

0 days-1 month,
1-5 months,
5-8 months,
>8 months"

Step Action
1. Press the Age groups button on the Reference ranges and
critical limits screen.
2. Use the following to set/change the age groups:
 Left/right arrows to choose the age group limit you want to
change (indicated by a blue circle with a white cross)
 Up/down arrows to scroll through the list of possible age limits. As
the list is scrolled, the text on the age-group bar changes
accordingly.
3. Repeat step 2 for each limit to be changed.
4. Press Back when completed to return to the Reference ranges
and critical limits screen.
5. Activate the Age group check button in the Reference ranges
and critical limits screen and select the desired age group.

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1. Setup ABL90 FLEX reference manual

Setting
reference and
critical limits
for each
parameter

Step Action
1. Highlight a parameter on the Reference ranges and critical
limits screen, using the up/down arrows.
2. Enter sample type, sex and age group, if required.
3. Press Edit to edit entries for a highlighted parameter.

4. If any entries are present and you cannot use any of them, press
Clear limits.
Then enter new critical and reference limits, using the keypad and
confirming each entry with Enter.
5. To change a value, touch and highlight it. Then enter the limit and
confirm with Enter.
6. Press Back to return to the Reference ranges and critical limits
screen.
7. Highlight a parameter in the "Parameter list" box to view the limits
on the Reference ranges and critical limits screen.

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ABL90 FLEX reference manual 1. Setup

Reportable ranges

Step Action
1. Scroll to the desired parameter, using the up/down arrows or the
scroll bar.
2. Key in the desired lower limit and confirm with Enter on the
keypad.
3. Key in the upper limit and confirm with Enter on the keypad.
4. To change the reportable range to the default (primary) setting,
highlight the desired parameter and press Set default.
5. To change all parameters to the default values, press Set all
default.
Press Continue to change the reportable ranges of all parameters
to the default ones.
Press Cancel to keep the user-defined reportable ranges and return
to the previous screen.
6. Press Close to exit and confirm the selected settings.

NOTICES:  A reportable range must be smaller than or equal to the range

of indication
 Measured parameters show the reportable ranges. Derived
parameters show "....."
 See also Calibration verification, chapter 6 in the ABL90 FLEX
operator's manual.

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1. Setup ABL90 FLEX reference manual

Patient report setup

Program In this program you can create a number of new layouts for patient reports or
modify the existing ones.
Press Menu > Utilities > Setup > Analysis setup > Patient reports to
access the program.

Creating a
layout

Step Action
1. Press New to make a new layout (marked "New") or Copy to make
a copy of a highlighted layout.
2. Press the Keyboard button next to the "Name" box, type in a new
name for your layout and confirm with Enter to return to the
Patient report setup screen.
3. Enforce, if desired, the Radiometer default settings on the
highlighted layout by pressing -R- default. This will give you a
starting point for designing your own layout.
4. Edit your layout as described in Editing a layout further in this
section.
5. If desired, make the highlighted layout a default for your analyzer
by pressing Make default. It will be marked with () in the list of
layouts.
6. Make a test printout, if desired, of the highlighted layout (patient ID
items and selected parameter groups with the parameters/units for
each parameter group) by pressing Preview. This test print will be
labeled "Preview".
7. To delete a highlighted layout, press Delete.
Note that the Radiometer default layout cannot be deleted. The
button is disabled if only the Radiometer default layout is available.

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ABL90 FLEX reference manual 1. Setup

Editing a layout Step Action

1. Highlight a layout in the list by touching it on the screen.
2. Press Edit patient ID layout to edit the patient ID items or press
Edit patient results layout to edit the parameter groups – see the
description further in this section.
3. Activate Print Acid-Base chart if an automatic printout of the
Acid-Base chart for this layout is desired.

Patient ID Selected patient

report layout
layout

Editing a patient ID for a selected patient report layout:

Step Action
1.  Add a highlighted item in the "Available items" box to the list of

selected items by pressing the button

Or
 Remove a highlighted item from the "Selected items" box by

pressing the button

2. Press Set as mandatory to make a highlighted item in the list of
selected items mandatory. The item will be indicated by a on 
the Patient ID screen and must be entered during a measurement
before a patient result can be viewed.
3. To remove the mandatory mark, highlight the item in the "Selected
items" box and press Set as mandatory again.

NOTICES:  To use the Patient lookup function, Department (Pat.) should

be selected for the Patient identification screen.
 To use the Request function, Accession number and/or Patient
ID should be selected for the Patient identification screen.

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1. Setup ABL90 FLEX reference manual

Default values

Changes to
List

Step Action
1. Highlight the desired item in the "Selected items" box with the
arrow buttons.
2. Set the default:
 If the item has a value, press Keyboard, enter the value and
press Enter on the keyboard to confirm
 If the item has a list of options, press List, highlight the option
using the arrow buttons and press Enter to confirm
3. Set or change other default values in a similar manner.

NOTICE:  It is not possible to set default values for all items

 The values can be changed on a result-by-result basis on the
Patient identification screen
 An item placed in the "Selected items" list does not appear in
the "Available items" list

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ABL90 FLEX reference manual 1. Setup

Editing patient
result layout

Step Action
1. Highlight a patient report layout on the Patient report setup
screen and press Edit patient results layout.
2.  Add a highlighted item in the "Available items" box to the list of

selected items by pressing the button

Or
 Remove a highlighted item from the "Selected items" box by
pressing the button
3. Select parameters for this parameter group by highlighting them

one by one and pressing .

(To exclude an item from the selected parameter list, highlight it

and press .)
4. Select another parameter group along with parameters for this
group in the same manner.
5. Use layout commands:
 <New group> (items following this command are placed at the
top of the next half of the screen)
 <New Line> (a line is inserted between items)
 <New Page> (items following this command appear on next
screen page) as desired

and press .

To show the range of a selected item, do the following:

Step Action
1. Highlight the desired item in the "Selected items" box.
2. Press Show ranges to indicate it by "[xxx-xxx]".
3. Repeat for other items in the same matter.
Refer to chapter 8: Parameters in this manual, for information on parameters
and their groups.

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1. Setup ABL90 FLEX reference manual

Sample pre-registration setup

This program allows you to select interpretation of the barcode and the patient
data that can be confirmed before and during a sample measurement.
Press Menu > Utilities > Setup > Analysis setup > Sample pre-
registration to access the program.

To select the settings, do the following:

Step Action
1. Use the up/down arrow buttons to select the interpretation of the
barcode setting in the "Interpret barcode input as" box.
Choose one of the following:
 Patient ID
 Accession Number
 Sampler ID.
Note that choosing the Accession Number or Sampler ID will gray
out its check button (Sampler ID on the screen above).
2. Select the barcode entry.
3. Activate the relevant check buttons in the" Included fields" box:
Accession no., Patient first name, Patient last name, Birth date,
Patient Sex.
4. Press Close to confirm the settings and return to the main screen.

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ABL90 FLEX reference manual 1. Setup

Sample age evaluation setup

This program allows you to set up a maximum sample age for the individual
parameters to enable an automatical sample age evaluation.
Press Menu > Utilities > Setup > Analysis setup > Sample age evaluation
setup.
To enable the sample age evaluation of the individual parameters, do the
following:

Step Action
1. Press the check button in the "Enable sample age evaluation" box.
2. Select the maximum sample age in minutes for pH, using the arrow
buttons.
3. To enable the same number of minutes for all parameters, press the
check button next to "Same rule for all the parameters".
4. Press Close to return to the main screen.

To edit the maximum sample age, do the following:

Step Action
1. In the Parameter/Aging timetable select the desired parameter.
2. In the "Maximum sample age in minutes" box select the desired
number of minutes, using the arrow buttons.
3. Press Close to return to the main screen.

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Calibration schedule setup

Program Press Menu > Utilities > Setup > Calibration schedule to access the
Calibration schedule setup program.
In the program you can do the following:
 Set the time for the first calibration each day. This is only an option, and if the
time is not set, the first calibration will by default start at 00:00 (12
midnight).
 Set the time for tHb calibrations
For more detailed information on calibration, see chapter 6: Calibration in the
ABL90 FLEX operator's manual.

24-hour scale shows the time for

each scheduled built-in
calibration, tHb calibration, built-
in QC and rinse.

Editing the Step Action

settings
1. Highlight the desired calibration on the screen and press Edit.
NOTICE: The Edit button is not available for Built-in QC.
2. Use the arrow buttons to select start time for calibrations and the
interval between each calibration.
As illustrated above, it is possible to link the QC schedule to the calibration
schedule and in this way minimize the number of activities and ensure the most
optimum utilization of the solution pack.
When the QC schedule is linked to the calibration schedule, the built-in QC will
by default run at the following times: 04:00, 12:00 and 20:00 (04 am, 12
midday, 8 pm). If, however, calibration is set to start at a different time than
00:00 (e.g. 00:30), the built-in QC will run correspondingly later.
If the QC schedule is not linked to the calibration schedule, you will have to set
the QC schedule yourself – see further in this chapter.
If the QC schedule is not linked to the calibration schedule, a rinse will be run at
the predefined times instead.

Available Option Interval

calibration
schedule tHb calibration Never, 7 days, 1 month, 2, 3, 4 or 6 months.
options Start time 00:00, 00:15, 00:30, 00:45.……. 23:45 or
12 midnight, 12:15 am, 12:30 am, 12:45 am…….12
midday, 12:15 pm…..11:45 pm.

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ABL90 FLEX reference manual 1. Setup

Quality control setup

Program Press Menu > Utilities > Setup > QC to access the Quality control solutions
setup and activate a button to enter a program.
The following programs are available:
 QC solutions
 QC schedule
 QC ranges
 QC input setup
 QC statistics
 Westgard Rules
 RiLiBÄK ranges
Built-in QC solution is set up together with the Calibration schedule (see earlier
in this chapter)

Manual quality control (QC) solutions

In this program you can assign or change a QC solution to a specific slot –

manual QC measurements only.
Built-in QC results are assigned to the slots A, B and C.

Step Action
1. Highlight a slot, using the arrow buttons.
2.  Solutions from Radiometer (the QUALICHECK5+ control solution):
scan the barcode or press Keyboard to enter the barcode
information (see Barcode reader in section Hardware, chapter 2:
What is what in the ABL90 FLEX operator's manual)
 Non-Radiometer control solutions: press Add Non-R-.
3. To delete a control solution, highlight the desired slot and press
Delete to cancel the operation.
A warning that this will irreversibly delete all statistical data related
to the selected slot appears. Press Delete to delete the control
solution.

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CAUTION – Changing QC
Changing a QC assigned to a slot will delete all current QC statistics
obtained on that slot. If you want a copy of the statistics for the last
QC month, create a WDC Report disk – see chapter 2: Disk functions
setup programs.

Quality control schedule setup

In this program you schedule QC measurements, both built-in and manual, for
your analyzer for all days of the week.

Navigation:

Use to select time during a day.

and

Use to display other weekdays.

and

Symbols for manual and built-in QC:

Measurement(s) on the manual QC.

Measurement(s) on the built-in QC performed automatically.

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ABL90 FLEX reference manual 1. Setup

Adding a new QC solution to a schedule:

Step Action
1. Select the desired time and press Add to display the screen above.
2. Touch the "QC slot" box to activate it, if not already activated.
Select the desired slot/quality control solution, using the up/down
arrows in the box. Confirm with Select.
Built-in QC results are assigned to the slots A, B and C.
3. Highlight the "Week days" box using Field down and activate the
relevant check buttons to select the days of the week on which this
measurement should be performed.
4. Highlight the "Start time" box, using Field up, and key in the time
to perform a measurement and confirm with Enter on the keypad.

5. Highlight the "Repeat" box and select the interval with which the
measurement should be repeated, using the up/down arrows in the
box.
The QC schedule reminder "Lock analyzer when QC overdue"
(selected in Corrective actions – see further in this chapter) will
work on the basis of the setting selected in this box.
The symbols for the built-in or manual quality control will
automatically appear in the schedule.
6. Press OK to return to the Quality control schedule setup screen.

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Editing the QC schedule:

Press Edit and follow the procedure above.

Deleting items from the QC schedule:

Step Action
1. Highlight the desired item (i.e. QC measurement) and press
Delete.
2. Press Event for this day, Event for all days or All entries for
QC slot to remove the QC measurement from the schedule.
When changes have been made to the QC schedule the Please
confirm screen appears when leaving the Quality control schedule
setup screen.

By default the analyzer is set up to run Built-in QCs after replacement and
startup. To deactivate this function deactivate the check button next to the "Run
Built-in QCs after replacement and startup".

QC ranges

In this program you can do the following:

 Globally update all control ranges of a slot to a calculated lot-to-date range
 Individually edit parameter control ranges by entering your own ranges or
updating to a calculated lot-to-date range
 Define a minimum allowed control range by entering a Fixed SD (standard
deviation)
For Built-in QC the Edit and Update all buttons are grayed-out.

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ABL90 FLEX reference manual 1. Setup

Step Action
1. Press Next slot to display the desired slot and then press Edit.

2. Select the parameter to be edited, using Next param. or Prev

param.
3. Press Update to change the range to the one shown in the "Lot to
Date range (2 SD)" box (if available).
4. Press the check button to activate or deactivate the Fixed SD (i.e. a
minimum allowed control range is defined by setting a Fixed SD).
To change the SD value, touch the "SD" field to highlight it and
enter the value, using the keypad. Confirm the entry with Enter.
5. Highlight the limit by touching it on the screen and enter your own
value(s), using the keypad. Confirm with Enter.
6. Repeat the procedure for other parameters in the same manner.

NOTICES:  See I Appendix - Quality control in this manual for detailed

information on statistics and its parameters
 "Lot-to-date range (2 SD)" is the range calculated over the
course of the lot, represented mathematically by the mean
value  2 SD; this is the range within which 95 % of the
measurements are found.

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Updating control ranges for all parameters of the displayed level:

Step Action
1. Display the desired slot, using Next slot.
2. Press Update all.
3. Press Continue to update the control ranges for all parameters
under the specified slot, or press Cancel to cancel updating.

NOTICE: Once the Fixed SD has been activated, you cannot update the control
ranges to limits that are narrower than those determined by the Fixed SD, for
both single-parameter and multiple-parameter updates.

QC input setup

In this program you can select the following for the Quality control
identification screen during a manual QC measurement:
 Mandatory temperature entry by the operator
 The default temperature always displayed (unless changed by the operator)

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ABL90 FLEX reference manual 1. Setup

Step Action
1. Activate the Mandatory temperature check button
2. Or highlight the default temperature in the "Default temperature"
box, enter a default temperature on the keypad and confirm with
Enter.

NOTICES:
 A  will appear next to an empty temperature box on the
Quality control identification screen during each QC
measurement; otherwise the result cannot be retrieved.
 The value in C or F is automatically entered on the Quality
control identification screen during measurement. The
temperature can be changed for a particular measurement but
will return to the default setting for future measurements.

QC statistics

In this program you can select the following:

 The statistics factor
 Automatic printing of QC statistics when the lot changes

Step Action
1. Key in the desired statistics factor (from 1.0 to 9.9) on the keypad
and confirm with Enter. The default value is 1.5.
2. Activate the check button in the “Built-in QC” field to automatically
make a printout of the QC statistics if the lot is changed.
3. Press Close to exit.

NOTICE: Statistics factor expands the control range to the statistics range (it is
the range within which QC results must fall in order to be included in the QC
statistics).

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1. Setup ABL90 FLEX reference manual

Westgard Rules setup

In this program you can select Westgard Rules for all slots or for specific
parameters.

Step Action
1. Select the desired slot, using Next slot.
2. Press On/Off to activate the assigned Westgard Rules for the slot
or press this button again to deactivate them.

NOTICE: The Westgard Rules are a set of statistical rules. When applied to the
QC results, they can increase the probability of detecting an error in the
sampling procedure or in the analyzer itself, or they can help detect a shift or
trend in your QC results by comparing current measurement values of a QC
solution with previous values.

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ABL90 FLEX reference manual 1. Setup

Activating Westgard Rules for a specific parameter:

Step Action
1. Display the desired slot, using Next slot and press Edit.
2. Display the desired parameter using Next param or Prev param.
3. Activate the desired Westgard Rule(s) by pressing the
corresponding check button.
(All future quality control data for the given slot/parameter will be
evaluated according to the selected Westgard Rule(s).)
4. Select Westgard Rules for other parameters or levels in the same
manner.
5. Press Back to return to the Westgard Rules setup screen.

Selecting/deselecting all Westgard Rules:

Step Action
1. Display the desired slot, using Next slot.

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1. Setup ABL90 FLEX reference manual

2. Press Select All or Deselect all and verify the information on the
screen.
Press Continue. Changes are made and shown in the Westgard
Rules Setup.
Press Cancel. No changes are made.

NOTICES:  When a QC measurement violates an applied Westgard Rule,

a W is added to the parameter in the result. For
interpretation/evaluation of the results with respect to
Westgard Rules, see I Appendix - Quality control in this
manual.
 Use On/Off to restore the previous settings.

Reference Westgard JO, Barry PLL. Cost effective quality control: managing the quality and
productivity of analytical processes. Washington: AACC Press, 1992.

RiLiBÄK ranges

The RiLiBÄK ranges program allows you to define a set of rules to control the
maximum deviation of any parameter from the assigned target value.
The assigned target values are given on the QC insert.
It is possible to define more than one rule for the individual parameters.
To activate or deactivate the RiLiBÄK rules, do the following:

Step Action
1. Press the On/Off button to activate/deactivate the assigned
RiLiBÄK rules.

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ABL90 FLEX reference manual 1. Setup

To add a new RiLiBÄK rule, do the following:

Step Action
1. Press the Add button to display the screen below:

2. Select the desired parameter from the parameter list shown in the
right side of the screen.
3.
Press until the first "Lower Limit" box is highlighted and enter
the desired lower limit.
4. Highlight the next box and select "<" or "<=".
5. Highlight the first "Upper Limit" box and select "<" or "<=".
6. Highlight the next "Upper Limit" box and enter the desired lower
limit.
7. To select the desired +/- range, press the desired radio button.
8. Enter the desired +/- range in the "Ranges" box.
9. Press Back to return to the RiLiBÄK ranges screen. The added
RiLiBÄK rule is now shown in the screen.

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1. Setup ABL90 FLEX reference manual

To edit a RiLiBÄK rule, do the following:

Step Action
1. Select the desired rule in the RiLiBÄK ranges screen and press
Edit to display the screen below:

2.
Use or to jump between the input boxes and edit the
desired values.
3. Press Back to return to the RiLiBÄK ranges screen.

To remove a RiliBÄK rule, do the following:

Step Action
1. Highlight the desired rule in the RiLiBÄK ranges screen and press
Delete.

NOTICE: When a QC measurement violates an applied RiLiBÄK rule, a red R is

shown in front of the parameter name in the result.

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ABL90 FLEX reference manual 1. Setup

Replacement setup
Program Press Menu > Utilities > Setup > Replacement setup to access the
Replacement setup and activate a button to enter a program.
The following programs are available:
 Replacement schedule
 User activities
 Maintenance planning
 Replacement warning

Replacement schedule setup

In this program you can schedule routine replacements along with the current
scheduled date and interval for replacement. The settings selected here are then
used in Replacement on the Analyzer status screen.

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1. Setup ABL90 FLEX reference manual

Step Action
1. Highlight the replacement action to be scheduled and press Edit.

2. Change the interval for the selected replacement action (displayed

in the "Action" box), using the up/down arrows (see Recommended
replacement intervals below).
The replacement schedule reminder "Lock analyzer when 10 %
overdue" (selected in Corrective actions – see further in this
chapter) will work on the basis of the setting selected in the
"Action" box.
3. Touch to highlight the "Next date" box and change the date, using
the screen keypad. Confirm with Enter.
4. Press Back to return to the Replacement schedule setup screen.
5. Repeat steps 1-4 for each replacement action to be scheduled.

Recommended Action Interval

replacement
intervals Replacing solution pack When the number of available activities has
reached zero or after max. 30 days in the
instrument
Replacing sensor cassette When the number of available tests has
reached zero or after max. 30 days in the
instrument
Replacing connection gasket Every 3 months
Replacing inlet gasket Tests/day Interval
10 3 months
20 1½ month
30 1 month
60 14 days
>120 7 days
NOTICE: The replacement intervals are guidelines only and based on the
average use of the analyzer (10 samples per day); under no circumstances do
they guarantee the lifetime of the replacement items. For analyzers with high
throughput, the replacement intervals should be adjusted accordingly in the
Replacement schedule.
It is possible to set the time for a warning to appear before a replacement – see
Replacement warnings later in this section.

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ABL90 FLEX reference manual 1. Setup

User activities

In this program you can formulate and schedule your own activities (e.g.
cleaning analyzer, replacing printer paper, etc.) along with the current
scheduled date and interval. The settings selected here are then used in the
Replacement status.

Adding a user
activity

Step Action
1. Press Add to display the Edit user activities schedule screen.
2. Press the Keyboard button and type a new activity. Confirm with
the Enter button on the keyboard.
3. Select the interval, using the up/down arrows in the "Interval" box.
4. Type in the "Next date", using the screen keypad. Confirm with
Enter.
5. Press Back to return to the User activities screen and repeat
steps 1-4 for each activity to be scheduled.

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1. Setup ABL90 FLEX reference manual

Editing a user Step Action

activity
1. Highlight the desired user activity on the User activities screen
and press Edit.
2. Press the Keyboard button to edit the text. Confirm the text with
Enter.
Change, if desired, the interval or next date (confirm the date with
Enter).
3. Press Back to return to the User activities screen and edit other
user activities in the same manner.

Deleting a user Step Action

activity
1. On the User activities screen, highlight the action to be deleted
and press Delete.
2. Press Continue to delete the activity or press Cancel to return to
the User activities screen.

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ABL90 FLEX reference manual 1. Setup

Maintenance planning

In this program you can plan replacements during a week and the shift.

Step Action
1. Activate the check buttons for the days on which maintenance is to
be performed.
2. Select the time at the beginning or the end of the shift, using the
up/down arrows.
3. Press Close to confirm the settings.

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1. Setup ABL90 FLEX reference manual

Replacement warnings

In this program you can set the time for a warning to appear before a
replacement. This will affect the status of the traffic light on the main screen.

Step Action
1. Select the number of remaining tests before the warning should be
given, using the up/down arrows.
2. Select the time before a replacement warning, using the up/down
arrows.
3. Select the expected measurements per day, using the up/down
arrows.
4. Press Close to confirm the settings.

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ABL90 FLEX reference manual 1. Setup

Parameters and input setup

Program Press Menu > Utilities > Setup > General setup > Parameters and input
setup and activate a button to enter a program.
The following programs are available:
 Parameters
 Units
 User-defined data items
 User-defined notes

Parameter setup

In this program you can do the following:

 Disable or enable a parameter
 Repress parameters if problems are detected
 Lock a parameter
 Make user-defined corrections for each measured parameter
 Make out-of-range suppression of oximetry parameters and bilirubin

Disabling/enabling a parameter:

Step Action
1. Highlight a parameter on the screen, using the scroll facilities.
2. Press Enable/Disable to include/exclude the parameter from a
parameter profile and the parameter bar. Note that pH, pCO2 and
pO2 cannot be excluded.

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1. Setup ABL90 FLEX reference manual

Locking/unlocking a parameter:

Step Action
1. Ensure that the analyzer is not connected to the RADIANCE system,
as parameters can be locked/unlocked from the RADIANCE system.
2. Highlight a parameter on the screen, using the scroll facilities.
3. Press Lock/Unlock. (This button is grayed-out if the analyzer is
connected to the RADIANCE system.)
4. To unlock a parameter, highlight it and press Lock/Unlock. The
traffic light on Analyzer status will change from YELLOW to a color
corresponding to the analyzer's overall status.

NOTICE: A locked parameter will show YELLOW on the parameter bar and will
change the overall analyzer status traffic light on the Analyzer status screen to
YELLOW. The parameter value will be absent from the printout; however, the
locked parameter will be calibrated.

Editing the parameter setup:

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ABL90 FLEX reference manual 1. Setup

Step Action
1. Highlight the desired parameter in the Parameter setup screen and
press Edit.
2. Activate (or deactivate) the following check buttons to select (or
deselect) the following functions:
 Repression (repress parameter value in patient result in case of
any problems)
 Out-of-range suppression for oximetry parameters or ctBil. When
activated, this function is applied to the oximetry/ctBil results
(including those obtained in the past) as follows:
o ctHb values lower than "0 g/dL", but inside the range of
indication will be shown as "0 g/dL"
o Oximetry parameter values (exclusive ctHb) inside the
range of indication, but lower than "0" or higher than
"100 %" will be shown as "0" or "100 %", respectively
o ctBil values lower than "0 µmol/L", but inside the range
of indication will be shown as "0 µmol/L".
3. Enter correction offset and correction slope. Confirm each entry with
Enter.
4. Press Back to return to the Parameter setup screen and repeat
steps 1-3 for another parameter, if desired.

CAUTION – User-defined corrections affect measurement

results
User-defined corrections for blood measurements will affect the
measurement results from blood and QC analyses and change the
specific performance characteristics unless "Apply parameter
corrections to QC" was disabled in Miscellaneous setup.

Units setup

In this program you can select the unit for each parameter or group of
parameters.

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1. Setup ABL90 FLEX reference manual

Step Action
1. Highlight a parameter or a group of parameters, using the arrow
buttons.
2. Select the unit, using the arrow buttons, and confirm with Select.
3. Change units for other parameters in a similar manner.
4. Press Close to return to the main screen.

User-defined patient data items

In this program you can include other patient data in the Patient ID layout than
those already available there.

Editing an item in the list:

Step Action
1. Highlight an item on the User-defined patient data items screen
and press Edit.

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ABL90 FLEX reference manual 1. Setup

2. Press the Keyboard button on the keypad and type in the new
name of up to 20 characters. Confirm with Enter on the keyboard.
3. Select the data type with the up/down arrows and press Select.
 For "Text" entry, go to step 8
 For "Numerical" entry, go to step 4
4. Highlight "Unit" and press the Keyboard button on the keypad.
Type in the new name of up to 20 characters and confirm with
Enter.
5. Highlight "Decimals" (if not already done) and the box with "0", "1",
"2","3" is displayed. Choose the number of decimals with the
up/down arrows and press Select to confirm.
6. Highlight "Max. value". Type in the value and confirm with Enter on
the keypad.
7. "Min. value" is now highlighted. Type in the value and confirm with
Enter on the keypad.
8. Press the check button to activate the "Use selection list" function.
To make a list:
 Press Add
 Type in the item on the displayed keyboard (up to 20 characters)
 Confirm with Enter
Add as many items as you wish in the same manner.
9. Press Back to return to the User-defined patient data items
screen. The new entry will be included in the list

NOTICE: The check button in the "Use selection list" can be activated only if the
list contains two or more items.

Including a new item in a patient ID layout:

Step Action
1. Press Menu > Utilities > Setup > Analysis setup > Patient
reports > Edit patient ID layout.
2. Follow the procedure described in Patient reports in this chapter.

Restore default:
To restore the default settings press Restore.

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1. Setup ABL90 FLEX reference manual

User-defined notes

Press Utilities > Setup > General setup > Parameters and input > User-
defined notes.

Adding a Note:
Step Action
1. Activate one of the check buttons on the screen.
2. Press Add.
3. Type the text for the Note, using the screen keyboard. Confirm with
Enter to save the text and return to the previous screen.

Editing a Note:
Step Action
1. Highlight a Note in the "Notes" box, using the up/down arrows, and
press Edit.
2. Edit the text and confirm with Enter.

Deleting a Note:
Step Action
1. Highlight a Note in the "Notes" box.
2. Press Delete.

NOTICE: A list of Notes made for a given option will be marked with a pencil
icon on the relevant screen(s).

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ABL90 FLEX reference manual 1. Setup

Analyzer settings
Program Press Menu > Utilities > Setup > General setup > Analyzer settings and
activate a button to enter a program.
The following programs are available:
 Analyzer ID
 Time/Date
 Acoustic signal
 Barometer
 Language

Analyzer identification

In this program you can change the analyzer's identification.

Step Action
1. Touch and highlight the "Analyzer name" box if not already
highlighted.
2. Type in an identification name and/or number for the analyzer (up
to 32 characters), using the screen keypad or keyboard. Confirm
with Enter.

NOTICE: The installation number cannot be changed. Quote this number in any
technical inquiries you may have to Radiometer.

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1. Setup ABL90 FLEX reference manual

Time/date setup

In this program you can change the current time and date setting.

Step Action
1. Highlight the "Time" box by touching it on the screen.
2. Key in the time on the screen keypad. Confirm with Enter.
Separators are automatically added between hours, minutes and
seconds.
3. Repeat steps 1-2 to set the date.
4. To revert to the previous settings, press Current.

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ABL90 FLEX reference manual 1. Setup

Acoustic signal setup

In this program you can set up a short beep to sound after certain events.

Step Action
1. Activate the desired check button(s).
2. Select volume for the acoustic signal or activate the "Mute all
acoustic signals" check button.

Available event Explanation

Value exceeds critical One of the measured values exceeds the specified
range critical limits for that parameter.
Close inlet The inlet should be closed.
Result is ready A sample has been analyzed and the results are ready
for viewing.
Inlet is open too long The inlet should be closed.

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1. Setup ABL90 FLEX reference manual

Barometer setup

In this program you can adjust the automatic barometer in accordance with the
reference barometer in your laboratory.

Step Action
1. Key in the desired pressure value on the keypad.
2. Confirm with Enter. The value will be shown in the "Measured
adjusted" box.
Maximum accepted correction is ±19 mmHg (i.e. the difference
between the "Measured unadjusted" and "Measured adjusted"
settings).
Barometer pressure limits are 450-800 mmHg, or 60.0-106.7 kPa,
or 450-800 Torr.
The units are selected in the Setup program: Units.

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ABL90 FLEX reference manual 1. Setup

Languages

In this program you can select or change a language of your choice from the list
of languages on your analyzer.
NOTICE: It is only possible to select or change languages if they have been
installed. Not all listed languages may be available.

Step Action
1. In the “Select a language from the list” box, select the desired
language with the arrows and press Set language.
To choose a special regional setting, e.g. English (US), select the
desired regional setting in the “Regional language” box and press
Set regional settings.
2. Press Continue to restart the analyzer.
Press Cancel to continue operating the analyzer with the language
unchanged.

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Communications setup
Program Press Menu > Utilities > Setup > General setup > Communications and
activate a button to enter a program.
The following programs are available:
 RADIANCE connection
 LIS/HIS connection
 Automatic data transmission
 Automatic data request
 Patient lookup setup
 QA Portal connection
See Rear in section Hardware, chapter 2 in the ABL90 FLEX operator's manual
for the identification and location of the serial RS-232 interface connection
(COM) and the network (TCP/IP) RJ45 Ethernet connection.

RADIANCE connection setup

In this program you can connect the analyzer to the RADIANCE system.

NOTICE: Connecting the analyzer to the RADIANCE system should be

performed by the RADIANCE administrator of your institution.

Step Action
1. Touch and highlight the "Server address" box. Type in the TCP/IP
address of your RADIANCE PC, using the screen keypad or
keyboard.
2. Touch and highlight the "Port" box. Type in the port number, using
the keyboard.
3. Touch and highlight the "Password" box. Type in your RADIANCE
password, using the keyboard.

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Step Action
4. Press the check button in the "RADIANCE communication" box to
activate connection.
5. The "Connection status" box with the handshake indicates an
established connection to the RADIANCE system.
6. The Icon in the "Connection status" box indicates the state of the
RADIANCE connection. "Connected" indicates an established
connection to the RADIANCE system.
A RADIANCE icon in the Information bar will indicate the established
connection as well.
7. Clear the queue by activating the recycle bin icon. (The "Output
queue" box shows the number of data queued up for transfer. It will
be sent to the RADIANCE system.)
8. Press Close to exit.

LIS/HIS connection setup

In this program you can select the communication protocol for a connected
device.

The "Output queue" box shows the number of data queued up for transfer to
LIS/HIS. Clear, if necessary, the queue by activating the recycle bin icon.

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Step Action
1. Press Add.

2. Press Keyboard, type in the name of the connection instead of the

default one, and press Enter.
Press Back to return to the LIS/HIS connection setup screen.
3. Select the high-level protocol according to the requirements of the
connected device, using the up/down arrows in the box.
Available protocols:
ASTM, ASTM6xx, HL7 ver. 2.2, HL7 version 2.5 or POCTDML1A.
4. Select the low-level protocol as follows:
 Use "Serial" or "Serial (RAW)" for the serial connection
 Use "Network (TCP/IP)" for the network connection
 Use "Network (TCP/IP)ASTM" for additional serial connection (not
all combinations of high-level protocols and low-level protocols
are possible)

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Step Action
5. Connection specifications for serial low-level protocol:
Press Edit to display the Connection specifications screen.
Press Edit to enter the options screen and use the up/down arrows
in each box to select baud rate, Com port and port configuration.
 Baud rate: 1200, 2400, 4800, 9600, 14400, 19200, 38400 –
default is 9600
 Com Port: COM1, COM2 – default is COM1
 Port configuration:
- Data bits: 5, 6, 7, 8, – default is 8
- Stop bits: 1, 1.5, 2 – default is 1
- Parity: None, Even, Odd – default is None
6. Connection specifications for network low-level protocol:
Press Edit to display the Connection Specifications screen.
Touch the screen to highlight the following boxes one after another:
 Server Address
 Com Port
 Reconnect interval
Use the keypad/keyboard to enter the relevant information.
7. Connection specifications for POCTDML1A low-level protocol:
Touch the screen to highlight the following boxes one after another:
Server Address  Port  Reconnect Interval.
Use the keypad/keyboard to enter the relevant information.

Automatic data transmission setup

In this program you can set up automatic transmission of data to a connected

LIS/HIS computer system or to the RADIANCE system.

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Step Action
1. Highlight a desired connection device on the screen, using the
up/down arrows.
2. Activate the relevant check button(s) to select the data to be sent
to the highlighted connection.

NOTICE: If the requested patient data (e.g. Patient Last Name) was received
after leaving the Patient identification screen, the patient report will be
transmitted without the data. To prevent this, select one of the patient data
items transferred from LIS/HIS as mandatory.

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Automatic data request setup

In this program you can select the conditions for requesting patient
demographics automatically from the connected RADIANCE system or from the
LIS/HIS computer system when entering patient ID, accession number or
sampler ID.

Step Action
1. Select a connected device in the "From connection" box, using the
up/down arrows.
2. Activate the relevant check button(s) to request patient
demographics when entering:
 Patient ID
 Accession number
 Sampler ID
3. Press Close when completed.

NOTICE: If the requested patient data (e.g. Patient Last Name) was received
after leaving the Patient identification screen, the patient report will be stored
without the data in the Patient report log. The requested patient data will be
stored as a patient profile in the analyzer's database without, however, being
attached to any patient report.

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Patient lookup setup

In this program you can select the data source from which to obtain the patient
information on the Patient identification screen.

Step Action
1. Select a data source from the established connections (local
database, RADIANCE or LIS/HIS connections).
2. Select the number of days you want each patient to be kept in the
list, using the up/down arrows in the box.
3. Press Close.

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QA Portal connection setup

This program allows you to connect the analyzer to a QA Portal.

If the QA Portal communication is enabled, the analyzer will automatically send
QC results and Cal Verification measurements to the QA Portal.

To enable communication with the QA Portal, do the following:

Step Action
1. Touch and highlight the "Server address" box.
Type in the TCP/IP address of your QA Portal, using the screen
keypad or keyboard.
2. Touch and highlight the "Port" box. Type in port number, using the
keypad.
3. Press the check button in the " QA Portal communication" box to
activate the connection.
The icon in the "Connection status" box indicates the state of the
QA Portal connection. "Connected" indicates an established
connection to the QA Portal.
4. Press Close to exit the screen.

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Disk functions setup

Program Press Menu > Utilities > Setup > General setup > Disk functions setup
and activate a button to enter a program.
The following programs are available:
 Automatic archiving
 Automatic backup

Automatic archiving setup

In this program you can select automatic archiving of the data logs by activating
the relevant check buttons.

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Step Action
1. Activate the check button to select automatic archiving on the
analyzer's disk.
2. To select another destination, deactivate the check button in the
"Archive destination" box and press the drive icon that appears.

3. Highlight the drive or folder and press Expand/Collapse to open a

folder in a directory or within a folder.
When completed, the correct destination appears in the upper part
of the box.
4. Press Back to return to the Automatic archiving setup screen.
5. Press Close to return to the main screen.

NOTICE: The oldest records (500 patient reports, QC or calibration results, or

2000 entries in the Activity log) will be automatically removed from a data log
and placed in the relevant archive. The archives can be stored on the analyzer's
disk and viewed in "Archived Data logs" or at a remote location.
For detailed information on archiving the old data, please refer to chapter 2:
Disk functions setup program in this manual.

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Automatic backup setup

In this program you can select automatic backup of all data and system files.

Step Action
1. Activate the check button.
2. Select time for automatic backup by highlighting the "Time" box and
typing in the time, using the screen keypad. Confirm with Enter.
3. Enter the interval between subsequent backups in the "Interval
(days)" box and type in the number of days, using the screen
keypad. Confirm with Enter.
4. Press the drive icon next to the "Destination" box to select
destination.
5. Highlight the drive or folder and press Expand/Collapse to open a
folder in a directory or within a folder.
Note that automatic backup can be selected for the internal disk or
the network.
When completed, the correct destination appears in the upper part
of the box.
5. Press Back to return to the Automatic backup setup screen.
6. Press Close to return to the main screen.

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Printers
Program Press Menu > Utilities > Setup > General setup > Printers and activate a
button to enter the program.
The following programs are available:
 Printer setup
 Automatic printing

Printer setup

In this program you can set up other printers than the analyzer's printer for
making printouts.

Step Action
1. Highlight a printer from the list, using the up/down arrows.
2. Press Select/Deselect to select the highlighted printer for printing.
You can install any number of printers, but only up to 10 printers
can be selected at a time.
3. Activate the check button in the "Manual printing" box to display the
list of printers every time the Print button has been pressed.
If not activated, all selected printers will make a printout every time
the Print button is pressed.
4. Press Edit to display the keyboard to change the highlighted
printer's name, Type a name and confirm with Enter.
5. To install a new printer, press Install printer.
The Add Printer Wizard program appears. This function can be used
by a Radiometer service representative or a person with network
knowledge. To get the desired printer installed the analyzer will run
a restart.

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Automatic printing

In this program you can select automatic printout of patient, QC (both manually
and built-in) and calibration results plus Activity log messages.

Step Action
1. Activate the desired check buttons for automatic printout.
2. Select automatic printout of several copies (1-5) of patient results,
using the up/down arrows in the "Patient results print options" box.
3. Press User, Manager or Service in the "Message level" box to
select the level for the messages in the Activity log.
4. Press Close to return to the main screen.

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Corrective actions
Program In this program you can select the following:
 Corrective actions for the events listed in the "Conditions" box
 Traffic light signal, if available, for an event
 Analyzer action for the subsequent measurements

Step Action
1. Highlight the desired condition, using the up/down arrows in the box.
2. Select an action for this condition from the options in the
"Corrective action(s)" box – see the table below.
3. Select the desired traffic light signal (YELLOW or GREEN, if
available) for the specified event by pressing the traffic light in the
"Traffic light signal" box – see the table below.
4. Select corrective actions/traffic light signal for the other conditions
in a similar way.

Conditions and Conditions and corresponding corrective action options are as follows:
corrective
actions
Condition Corrective action Traffic light
Calibration error(s)  Do not run scheduled built-in QC GREEN or
present YELLOW
Calibration schedule  Message on next patient result GREEN or
reminder(s) YELLOW
QC error(s) present  "?" on specific parameters YELLOW
QC schedule  Message on next patient result GREEN or
reminder(s) YELLOW
 Lock analyzer when QC overdue GREEN or
YELLOW

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Replacement  Message on next patient result GREEN or

schedule reminder(s) YELLOW
 Lock analyzer when 10 % overdue GREEN or
YELLOW
System message(s)  Message on next patient result GREEN or
present YELLOW
User activity GREEN or
reminder(s) YELLOW
Built-in QC error(s) Rerun same level once (default OFF)
present

NOTICE: Critical system messages will always result in a RED traffic light
signal.
The specified traffic light signal and the messages will continue to appear until
the condition no longer exists.

Explanation of Corrective action Explanation

corrective
actions "?" on specific The affected parameter(s) will be marked with "?" in
parameters subsequent patient results.
Message on next The subsequent patient results will be marked on the
patient result Message screen.
Lock analyzer If a scheduled quality control measurement is more than
when QC overdue 0 % overdue compared with its scheduled time, the
analyzer will be locked.
Lock analyzer If a scheduled replacement procedure is more than 10 %
when 10 % overdue compared with its scheduled time, the analyzer
overdue will be locked.

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Miscellaneous setup
Program In this program you can select the following options (use the arrow buttons to
display the rest of the options):

List of options Option Function

Analyzer locked Suspends all measurements on the analyzer; other
functions such as calibrations and service programs
are still enabled.
The analyzer can be locked via this program or via a
"lock" command from an externally connected
system, e.g. LIS or RADIANCE.
Enable estimated Enables estimation of the derived parameters based
derived parameters on default values and parameters that have been
deselected or are not available.
Fixed pO2/pCO2 If enabled, these parameters will be reported with a
decimals fixed number of decimals.
Enable general Enables every text box on the Patient profile,
barcode support Patient identification, Patient result and Quality
control identification screens where it is possible
to enter a barcode.
Enable patient result Enables the additional buttons on the Patient
approval Result screen used for approval of results.
For detailed information, refer to chapter 4: Sample
measurement in the ABL90 FLEX operator's manual.
Apply parameter If enabled, the user-defined corrections (slope and
corrections to QC offset) will be applied to the QC results.
Log all measurement If enabled, "Ready", "Rinse", "Aspirating" and
activities "Measurement" will be registered in the Activity log.
Otherwise these activities will not be registered in
the log. This option aims to avoid too many entries
in the log.
Auto temp unit C will be automatically changed to F if the entered
conversion temperature is over the value of 45.
Enable screen saver The screen saver will appear if the analyzer has been
idle for 5 minutes.

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Option Function
Show parameter bar If disabled, the parameter bar will not appear on the
main screen.

Activating/ Step Action

deactivating an
option 1. Scroll the list of options with the up/down arrows.
2. Highlight the option and press the check button next to it. To
deactivate the option, press the check button again.
3. Press Close to confirm the settings and return to the main screen.

Selecting HbF This option disables HbF correction for all levels, or enables it for all levels or for
correction HbF levels higher than 20 %.
To select the desired option, use the arrow buttons in the box.
Guidelines for selecting/deselecting HbF correction:
For neonatal Use "Enabled for all levels".
samples: It is important to enable HbF correction to obtain
correct results for ctBil, sO2, FO2Hb, FMetHb, FCOHb
and FHHb.
For adult samples: Use "Disabled" or "Enabled for levels > 20 %".

NOTICE: When an adult sample is measured with HbF correction "Enabled for
all levels" or "Enabled for levels > 20 %", it will slightly affect the measurement
of sO2, FO2Hb, FMetHb, FCOHb and FHHb, and will cause a marginal number of
adult samples reported with HbF present.

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Analyzer A message, sent from the RADIANCE system to the connected analyzer and
messages displayed on the main screen, can be changed or deleted in this program.

Step Action
1. Press the Keyboard button, type the message (up to 40 characters
long) and confirm with Enter.
To delete the current message, press Delete on the keyboard, or
delete a message and type a new one, if desired.
2. Confirm the change with Enter to return to the Miscellaneous
setup screen.

Setting the Step Action

time for the
1. Check that the “Enable screen saver” check button is activated in
screen saver to
appear the “Setup” box.
2. In the “Screen saver” box, select the time with the arrow buttons.

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Setup default settings

Access to Press Menu > Utilities > Disk functions > Restore default setup.
Radiometer
You can select the parts of the Setup to be set back to Radiometer defaults.
default setup

Operators and Item Setting

passwords
User password 123456
Logoff time 3 minutes

Default settings for Access profiles are as follows:

A B C D E F G H I
User X X X (X) X
Supervisor X X X X X X X X
Manager X X X X X X X X
Service techn. X X X X X X X X X
Guest X (X)
Custom 1 (X)
Custom 2 (X)
Custom 3 (X)
Remote X X X X X X X X
operator

A = Perform measurement F = Edit data in logs

B = Perform calibration G = Enter Setup Programs
C = Perform replacements H = Enter Service Programs
D = Perform Disk Functions I = Approve results
E = View Data Logs

Columns D, E, G and H are controlled via the Menu and button configuration
screen settings, not via the check buttons on the Access profiles screen.
(X) means restricted access to data logs:
 User can view the logs, but there is no access to the archived data logs
 Guest and Custom can view Patient results log and Quality control log

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Analysis setup Analysis setup Default setting

Syringe modes S65 µL; ampoule QC. All user-defined modes are
deleted.
Capillary modes C65 µL. All user-defined modes are deleted.
Parameter profile All parameters (except FHbF) are selected.
Dynamic Parameters: Off
Sample pre-  Interpret barcode input as: Sampler ID
registration
 Confirm pre-registered data: On
 Included fields: All fields On
Sample logistics Sample age: On (30 minutes for all parameters)
setup
Patient reports  Layouts: -R- Default
 Patient ID layout settings included in the -R-
Default layout:
- Patient ID
- Patient last name
- Patient first name
- Sample type
- Temp. °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 Line >

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1. Setup ABL90 FLEX reference manual

Analysis setup Default setting

Patient reports Electrolyte values
(continued)
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
< 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)

Calibration Activity Default setting

schedule
tHb calibration 3 months
Start time of first calibration 00:00
Link QC schedule to calibration schedule On

Quality control Program Item Default setting

setup
QC statistics Statistics factor 1.5
Cut-off date for month-to-date 1
statistics
Remind to print statistics each No
month
Remind to export WDC data each No
month

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ABL90 FLEX reference manual 1. Setup

QC input setup Mandatory temperature No

Default temperature 25 °C
QC schedule Built-in QC (S9030, S9040, S9050) 04:00, 12:00,
20:00
Westgard Rules All rules are "Off"
Run QC after On
replacement

Replacement Program Item Default setting

setup
Replacement Inlet gasket 3 months
schedule
Inlet probe Never
Connection gasket 3 months
Clean inlet Never
User activities None –
Maintenance None –
planning
Replacement Number of activities before 5
warnings replacement warning
Time before replacement warning 4 hours
Expected measurements per day –

General setup Parameter setup default settings:

Para- Enabled/ Repression Offset Slope Units Out-of-range
meter Locked suppression
pH Not altered No 0.000 1.000 N/A
pCO2 Not altered No 0.0 1.000 mmHg N/A
pO2 Not altered No 0.0 1.000 mmHg N/A
ctHb Not altered No N/A 1.000 g/dL No
sO2 Not altered No 0.0 1.000 % No
FO2Hb Not altered No N/A N/A % No
FCOHb Not altered No 0.0 N/A % No
FMetHb Not altered No 0.0 N/A % No
FHbF Not altered No 0 1.000 % Yes
FHHb Not altered No N/A N/A % No
cK+ Not altered No 0.0 1.000 mmol/L N/A
+
cNa Not altered No 0 1.000 mmol/L N/A
cCa2+ Not altered No 0.00 1.000 mmol/L N/A

cCl Not altered No 0 1.000 mmol/L N/A
cGlu Not altered No 0.0 1.000 mmol/L N/A
cLac Not altered No 0.0 1.000 mmol/L N/A

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ctBil Not altered No 0 1.000 µmol/L Yes

Units default settings:

Parameter Unit
Pressures 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
2+
cCa mmol/L
cGlu mmol/L
cLac mmol/L
Temperatures °C
ctO2 Vol %
ctCO2 Vol %
· mL/min
D O2
· mL/min
V O2
Age years
Weight kg
Height m
Altitude m
Birth weight g

User-defined patient data items default settings:

Name Type Unit Decimals
Spontaneous RR Numerical b/min 1
Set RR Numerical b/min 1

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Vt Numerical L 2
Ve Numerical L 2
Peak flow Numerical L/min 1
Liter flow Numerical L/min 2
Ti Numerical seconds 1
PEEP Numerical cmH2O 1
Pressure support Numerical cmH2O 1
CPAP Numerical cmH2O 1
CMV Numerical Rate 1
SIMV Numerical Rate 1
Flow-by Numerical L/min 1
HFV Numerical Rate 1
I:E ratio Numerical None 2
Wave Numerical None None
ICD9 code Numerical None None
Oxygen device 1 Numerical None None
Oxygen device 2 Numerical None None
Diagnostic code Numerical None None

User-defined notes default settings: No notes defined.

Language default setting: English.

Acoustic signals default settings:

Event Default setting
Value exceeds critical limits No
Close inlet Yes
Result is ready Yes
Inlet is open too long Yes

Corrective actions default settings:

Event Default setting Traffic light
Calibration error(s) present Do not run QC YELLOW
Calibration schedule reminder(s) No setting YELLOW
QC error(s) present ? on specific parameters YELLOW
QC schedule reminders No setting YELLOW
Replacement schedule reminders No setting YELLOW
System message(s) present No setting YELLOW
User activity reminder(s) No setting YELLOW
Built-in QC error(s) present No setting YELLOW

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Miscellaneous setup default settings:

Event Default setting
Analyzer locked Not set
Enable estimated derived parameters Off
Fixed pO2/pCO2 decimals Off
Enable general barcode support On
Enable patient result approval Off
Apply parameter corrections to QC On
Log all measurement activities Off
Auto temp unit conversion On
Enable screen saver On
Show parameter bar On
HbF correction "Enabled for levels > 20 %"
Analyzer message (Blank)
Screen saver 5 minutes to wait when idle

Automatic printing default settings:

Item Default setting
Patient results On
QC results Off
Calibration results Off
Activity log message Off
Message level User
Number of copies 1

Printer setup default settings:

Item Default setting
Installed printers Internal Printer
(added printers
are not deleted)
Select printer dialogue Off

Automatic archiving default settings:

Item Default setting
Patient report log On
Calibration log On
Quality control log On
Activity log On
Store archives on the analyzer On

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Automatic backup default settings:

Item Default setting
Auto backup on

Communication setup default settings:

Item Default setting
RADIANCE system Off
LIS/HIS None
Automatic data request "When entering sampler
ID" – on
Automatic data transmission Patient results, Calibration
results, QC results, Activity
log messages
Patient lookup Local database
Remote control Enable remote access

Setups without The following setups have no Radiometer settings:

Radiometer
 Barometer setup
settings
 Time and date setup
 Analyzer identification setup

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Print setup
With this program you can print out all or part of your analyzer setup.

Step Action
1. Press Menu > Utilities > Setup > Print analyzer setup.
2. All check buttons are activated.
Deactivate relevant check buttons to deselect those setups that you
do not wish to be printed out.
3. Press Print to start printing the selected setups or press Close to
return to the main screen.

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Contents of setup settings

Press Menu > Utilities > Disk functions > Restore default setup to access
the Restore radiometer default setup program.

Groups of The setup is divided in the following groups of settings:

setup settings
 Parameters
 General
 Schedules, etc.

You can restore the Radiometer default setup or a setup you have customized
(Customer setup) and saved.
Selecting or deselecting items in the setup – see Loading/restoring setup,
chapter 2: Disk functions setup programs.
Each setup group of settings is described in this section.

Parameters The following settings (i.e. screens and their data) will be restored in the
group Parameters group:

Item Setup (screens)

Sample modes  Syringe mode
 Capillary mode
 Parameter setup (offset and slope only)
Parameter units  Units setup
Corrections  Parameter setup (repression and out-of-range
suppression only)
Critical ranges  Reference ranges
 Critical limits
 Age groups

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General group The following settings (i.e. screens and their data) will be restored in the
General group:

Item Setup (screens)

Analyzer setup  Corrective actions
 Acoustic signals
 Low level warning
Ini file  Selected language
 Printer path
Ini settings and  RADIANCE connection
communications
 LIS/HIS connection
 Automatic data transmission
 Automatic data request
 Patient lookup setup
 Operators and passwords (logon protection level and
logoff time only)
 Miscellaneous setup (all, except analyzer locked)
 Automatic printing
 Automatic archiving
 Automatic backup
 Save setup (destination)
 Load setup (source)
 Backup all data (destination)
 Export data logs (destination)
 Function: External keyboard enabling
 Function: Enable remote access when operator is
logged on
 QC statistics setup
 QC input setup
 Westgard Rules (enable Westgard Rules)
 Printer setup (show list of printers)
Layouts  Patient report setup
 Patient ID layout
 Patient result layout
 User-defined data items
 The width of the following column setups:
Patient results log; Patient lookup; Patient profiles log;
QC log; Calibration log; System messages;
Replacement schedule
Operators  Operators and passwords
 Access profiles
Pre-def. notes  User-defined notes

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ABL90 FLEX reference manual 1. Setup

Schedules, etc. The following ini files (i.e. screens and their data) will be restored in the
Schedules, etc. group:

Item Setup (screens)

QC schedule  QC schedule (QC schedule is restored for the slots with
the control solutions installed in them. The schedule
follows the slots, not the QC levels).
Wet section setup  Calibration schedule (minus tHb Cal and the start time)
Westgard rules  Westgard rules settings
Replacement  Replacement schedule
schedule
User activities  User activities
schedule
 Edit user activities

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1. Setup ABL90 FLEX reference manual

Interfacing facilities
Connecting a A mouse connected to the analyzer may be used to activate all the analyzer's
mouse screen functions instead of the operator touching the screen.
A standard PS/2 port mouse or a USB mouse is the sole item that is required for
connection to the analyzer.
Connecting a mouse:
Step Action
1. For a standard PS/2 port mouse only: Switch off the analyzer.
2. Connect the mouse to the mouse port at the rear of the analyzer.
3. For a standard PS/2 port mouse only: Switch on the analyzer. After
restart the mouse is ready for use.
A USB mouse can be used right after it has been connected.

Connecting an An external alphanumeric keyboard may be used to enter data instead of the
alpha-numeric on-screen keyboard. However, to select individual buttons on the analyzer
keyboard screen, you must use a mouse or must touch the screen.
An IBM enhanced personal computer keyboard or a USB keyboard is the sole
item that is required for connection to the analyzer. The keyboard layout must
correspond to the language version used by the analyzer.
Connecting a keyboard:
Step Action
1. For an IBM enhanced personal computer keyboard only: Shut down
the analyzer.
2. Connect the keyboard to the keyboard port at the rear of the
analyzer.
3. For an IBM enhanced personal computer keyboard only: Turn on the
analyzer. After restart the keyboard is ready for use.
A USB keyboard can be used right after it has been connected.

Connecting to a Many hospitals are equipped with a computer-controlled information system

network such as the Hospital Information System (HIS) or the Laboratory Information
System (LIS). Connecting the analyzer to such an information system via a
network enables the user to exercise greater control over the amount of patient
data circulating within the hospital.
The types of information that can be communicated via a network between the
central computer controlling the information system and the analyzer are:
 Patient results
 Quality control results
 Calibration data
 System messages

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ABL90 FLEX reference manual 1. Setup

Step Action
1. Use a shielded data cable with an RJ45 connector to connect the
analyzer to a network.
2. The analyzer is first connected to the computer controlling the
information system via one of the following two interfaces:
 A serial line (RS232 interface)
 An Ethernet interface (TCP/IP)
3. Once the analyzer has been physically connected to the network,
one of two of the protocols stated below is used for communication
with the central computer.
 ASTM
 HL7
 POCTDML1A

For further information, refer to the Communication protocol specifications for

Radiometer products (code no. 989-329).
Radiometer recommends that a qualified service technician carry out connection
of the analyzer to a network.

External An external barcode reader can be connected and used side by side with the
barcode reader built-in barcode reader – contact your Radiometer service representative.

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1. Setup ABL90 FLEX reference manual

Sample counter
Purpose The sample counter lets you keep track of measurements, calibrations and QC.
Press Utilities > Sample counter to enter the program.

Description

Element Function
Parameter and List the parameters and how many times each has been
Count measured by the analyzer. Normally the count is the same
as the total number of measurements if the parameters have
not been excluded from the measurement(s).
Counters Shows the number of sample measurements, calibrations
and QC measurements made since the sample counter was
last reset ("User" column). The following is registered:
Activity Number of...
Total Completed sample/QC measurements/
calibrations only. Interrupted or aborted activities
are excluded.
Aborted Aborted sample/QC measurements/calibrations
due to sample errors, wet-section errors, etc. –
interrupted activities excluded.
User All completed sample/QC measurements/
calibrations performed by all operators since the
sample counter was last reset.
User counters Gives the date when the counters in the "User" column were
last reset last reset to zero.
Buttons  Reset counters resets the counters in the "User" column
(on analyzers with no logon protection of the Setup
programs).
 Print prints out information in Counters and in Parameter.

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 2. Disk functions setup programs

General information........................................................................... 2-2

Creating a WDC report....................................................................... 2-3
Backing up all data............................................................................ 2-4
Restoring all data .............................................................................. 2-6
Exporting data logs ........................................................................... 2-7
Importing/exporting archives.............................................................. 2-8
Saving setup .................................................................................... 2-9
Loading/restoring setup ....................................................................2-10

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2. Disk functions setup programs ABL90 FLEX reference manual

General information
Disk functions To access the Disk functions programs, press Menu > Utilities > Disk
programs functions.
The following programs are available by pressing a corresponding button.

Button Function
WDC report To make a Worldwide DATACHECK report.
Backup all To make a backup of all data. Data is stored as a backup at a
data designated location.
Restore all To restore a backup of all data files to the analyzer's internal
data disk from a designated location.
Export data To export selected records from selected data logs.
logs
Import/ To import externally archived data logs.
Export
To export or delete archived data logs.
archives
Save setup To save the current setup of your analyzer.
Load setup To load a previously saved setup.
Restore To restore all or only some Radiometer default settings.
default setup

Definitions Setup data refers to information or files that configure the analyzer to operate
according to settings defined in the Setup programs.
All data refers to data in the analyzer's internal database, including but not
limited to data logs, setup and system files.

Data storage Information is stored on or retrieved from the internal disk, a network, a
options connected CD-drive (CD-RW, CD-R/RW) or a removable drive (USB mass
storage device).

Disk handling The CD-drive and removable drive (USB mass storage device) should be
rules handled according to the instructions on the packaging.

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ABL90 FLEX reference manual 2. Disk functions setup programs

Creating a WDC report

Purpose With this function you can make a Worldwide DATACHECK (WDC) file for
reporting monthly quality control data. For information on Worldwide
DATACHECK reporting, see the Worldwide DATACHECK manual.

Step Action
1. Touch the "From:" box in the “Select period” box and set the dates
for the desired month, using the up/down arrows. The date in the
"To:" box will change automatically.
2. Highlight the desired drive or folder (another directory, removable
or externally connected CD-drive) by pressing the Disk drive
button on the screen, and touching it on the screen. Press
Expand/Collapse to open a folder in a directory or within a folder.
When completed, the correct destination appears in the upper part
of the box.
Press Back to return to the previous screen.
3. In the "File name" box (the WDC report screen), press the
Keyboard button to type the file name: you can change the four
characters "WDC_".
Confirm with Enter on the keyboard and return to the WDC report
screen.
4. Send the file to the selected destination by pressing Export data in
the "Export data" box.
Wait until the WDC report screen appears and remove the disk, if
any, with the WDC report.

NOTICES:  "Could not create output file" appears if the destination is not
accessible.
 "No statistical data found. WDC data not generated" appears
if no data is available for the selected month

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2. Disk functions setup programs ABL90 FLEX reference manual

Backing up all data

Purpose This function is intended as a protection or security against the loss of data or
system files that include, but are not limited to, the following:
 Patient report data
 Patient profile data
 Setup data
 Quality control data (i.e. results, statistics, plots)
 Calibration results and setup (i.e. schedule)
 Activity data (i.e. replacement actions, system messages)

Manually performed backup: Data can be stored on a network, a connected CD-

drive or a removable drive.
Automatic backup (can be selected – see Automatic backup setup in section Disk
functions setup, chapter 1 in this manual): Data can be stored on the internal
disk or the network.
In case of data loss or similar problem, the loss can be minimized by using the
backup file and the Restore All Data function.

NOTICE: It is the user's responsibility to ensure that all valuable data is

regularly backed up. During the analyzer warranty period Radiometer accepts
warranty responsibility only for the original storage hardware and installed
software.

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ABL90 FLEX reference manual 2. Disk functions setup programs

Step Action
1. Press Change destination to choose the destination.
2. Highlight the drive or folder by touching it on the screen. Press
Expand/Collapse to open a folder in a directory or within a folder.
When completed, the correct destination appears in the upper part
of the box.
If a removable drive is used, connect it to the USB port
Press Back to return to the previous screen.
3. On the Backup all data screen press Start to continue.
4. The backup process begins.
 Network drive or internal disk: Backup continues without any
further action from the operator
 Removable drive: Wait for the data to be prepared (see the timer
in the current task field located next to the status indicator in the
upper left corner of the screen) and press Start.
5. If the analyzer status shows a "Backup done" message, the process
is complete. Press Close to return to the main screen.

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2. Disk functions setup programs ABL90 FLEX reference manual

Restoring all data

Purpose You can restore all data in case of loss or damage, provided the backup of all
your data is available.

Step Action
1. Press Change source to choose the source drive/directory.
2. Highlight the drive or folder by touching it on the screen. Press
Expand/Collapse to open a folder in a directory or within a folder.
When completed, the correct destination appears in the upper part
of the box.
If a removable drive is used, connect it to the USB port.
Press Back to return to the previous screen.
3. On the Restore all data screen press Start to continue.
(Or press Close to cancel and return to the main screen.)
4. The restore process begins.
 Network: Restoring does not require any further action
 Removable drive: Press Start
5. Complete restoring all data.
When restoring is complete, the analyzer shuts down and restarts
automatically, configured to the information obtained from the
backup file.

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ABL90 FLEX reference manual 2. Disk functions setup programs

Exporting data logs

Purpose You can export data from the data logs to a CD-RW, removable disk or network.
The exported files are made in a form of a compressed "comma separated value
(CSV)" file which can be read using a number of standard database and
spreadsheet programs, e.g. Microsoft Excel®, Access®, Lotus 123®, etc.

Step Action
1. Activate the check buttons next to the data logs to be exported.
2. Activate the calendar icon, the Choose date screen appears. Type
the "From:" date and confirm with Enter. Repeat the same for the
"To:" date.
Press Back to return to the Export data logs screen.
3. Activate the Disk drive button on the Export data logs screen.
Activate the desired drive by touching it on the screen.
Press Expand/Collapse to open a folder in a directory or within a
folder.
When completed, the correct destination appears in the upper part
of the box.
Press Back to return to the Export data logs screen.
4. On the Export data logs screen press Start. The Save Data Logs
screen, showing the data logs to be exported, the amount of saves
and the From-To export dates, appears. Press Start to begin the
export of data to the selected destination.
5. If the dates are different for each exported data log, repeat steps
2-5 for each data log.

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2. Disk functions setup programs ABL90 FLEX reference manual

Importing/exporting archives
Purpose This function allows you to do the following:
 Export (or delete) archived data logs stored onto any drive
 Import externally archived data logs into the analyzer's archive directory from
any location

Exporting an Step Action

archive
1. Select the desired archive type by activating one of the four
archive-type buttons.
2. Highlight the desired archive with the up/down arrows.
3. To export the highlighted archive, select the location by pressing
the Disk drive button.

Touch and highlight the desired location on the

Source/Destination screen.
Press Expand/Collapse to open a folder in a directory or within a
folder.
When completed, the correct destination appears in the upper part
of the box.
4. Press Back to return to the Import/Export archives screen.
5. On the Import/Export archives screen press Export.
Press Refresh to update the contents of a drive or directory.

Importing an To import an archive, follow the procedure for exporting an archive, using the
archive right-hand section of the screen and Import.

Deleting an To delete an archive from a directory, highlight the desired archive and press
archive Delete.

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ABL90 FLEX reference manual 2. Disk functions setup programs

Saving setup
Purpose You can copy your analyzer's current setup configuration onto a CD-RW,
removable drive, or network. It can be reloaded if the current setup is lost or
damaged or if the same setup configuration should be loaded on other analyzers
without performing all the Setup programs.

Step Action
1. Press Edit location to select destination.
2. Select the required location by touching it on the screen.
If a removable drive is used, connect it to the USB port
Press Expand/Collapse to open a folder in a directory or within a
folder.
When completed, the correct destination appears in the upper part
of the box.
3. Press Back to return to the Save setup screen.
4. On the Save setup screen press Start.
5. When saving is complete, press Close to return to the main screen.
6. Remove the removable drive, if any.

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2. Disk functions setup programs ABL90 FLEX reference manual

Loading/restoring setup
Purpose You can reinstall a saved setup quickly and easily without performing the Setup
programs. If desired, only part of the setup can be loaded, e.g. operators.

Step Action
1. Press Select all to include all items from the list on the screen. Or
press Deselect all to exclude all items from the list.
2. To select single items, highlight the desired item, using the
up/down arrows.

Press the check button () to include an item.

3. To open or close a group of items, highlight the group title (e.g.

General) and press the  button.
4. Press the Change source button to select the source.
Removable disk: Connect it to the USB port.
5. Select the required source by touching and highlighting it on the
screen.
6. Press Expand/Collapse to access the required folder. The chosen
source appears in the "Choose a directory" box.
7. Press Back to return to the Load setup screen.
8. Press Continue. The analyzer will shut down and then restart with
reloaded setup configuration.
Pressing Cancel will terminate loading the setup.

NOTICE: Contents of Setup settings – see Setup default settings, chapter 1 in

this manual.

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 3. Wet section

Introduction ........................................................................................... 3-2

Wet section diagram................................................................................ 3-3
Measuring processes ............................................................................... 3-4
General information................................................................................. 3-4
Patient samples ...................................................................................... 3-5
Rinse process ......................................................................................... 3-6
Calibration ............................................................................................. 3-7
Automatic QC ......................................................................................... 3-8
Manual QC samples ................................................................................. 3-9
3. Wet section ABL90 FLEX reference manual

Introduction
Definition The wet section of the analyzer is where all samples and solutions are
transported for measurement, calibration, rinse and quality control.
All solutions for the ABL90 FLEX analyzer are contained in the solution pack.
Gas tanks are not necessary with the ABL90 FLEX analyzer, as gas is included in
the solution pack.

Contents of The main components of the wet section are:

wet section
 Inlet
 Sensor cassette
 Oximetry system
 Internal tubing
 Tube valve
 Peristaltic pump for solution and sample transport
 Liquid sensors
 Waste connector
 Solution pack containing three calibration solution pouches (one of them being
for rinse), one gas mixture pouch, three quality control solution pouches, a
flow selector, pump tubing and a waste pouch.

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ABL90 FLEX reference manual 3. Wet section

Wet section diagram

Diagram The following is a schematic diagram of the wet section of the ABL90 FLEX
analyzer.

Item Part Item Part

1 Oximetry module 11 Waste pouch
2 Reference electrode 12 CAL 3 pouch
3 Sensor interface 13 CAL 1 pouch/rinse
4 Optical pO2 14 Gas mixture pouch
5 Inlet 15 QC 1 solution pouch
6 Valve 16 CAL 2 pouch
7 Liquid sensor 3 17 QC 3 solution pouch
8 Liquid sensor 2 18 QC 2 solution pouch
9 Liquid sensor 1 19 Flow selector
10 Peristaltic pump 20 Pump tube
21 Waste connector

3-3
3. Wet section ABL90 FLEX reference manual

Measuring processes
Introduction The following pages describe the process that occurs within the analyzer during
sample introduction, rinse, calibration and quality controls. The various types of
sampling modes are discussed separately.
All processes refer to the wet section diagram earlier in this chapter.

General information
Prior to When the analyzer is in the Ready mode prior to a measurement, the sensor
measurement cassette contains CAL 1 from the solution pack.

Heating The sensor cassette measurement chamber and the cuvette in the hemolyzer
unit of the optical system is thermostatted to 37 °C to ensure correct measuring
conditions.

Solutions All necessary solutions contained in the solution pack are introduced
automatically as required into the sensor cassette and oximetry module via the
flow selector and inlet.

Waste removal All waste liquids are transported to the waste pouch contained in the solution
pack. This includes blood sample waste.

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ABL90 FLEX reference manual 3. Wet section

Patient samples
Measuring The following table describes the analytical process of a blood sample
process measurement with the ABL90 FLEX analyzer system.

Stage Description
1. The analyzer is ready to accept a patient sample.
 "Ready" message is displayed
 Traffic light is displaying a GREEN or YELLOW light
 The desired parameters are available
2. At the Ready screen, the user lifts the inlet handle to the syringe or
capillary position. The sample (syringe or capillary tube) is pressed
against the inlet gasket and the inlet probe extends into the sample,
which is automatically aspirated. A 1-point calibration is performed
by sampling on the CAL1 (rinse) solution.
3. The sample is drawn into the sensor measuring chamber and the
oximetry module. This process is controlled by liquid sensors that
also check sample homogeneity with respect to air bubbles. A "?"
appears in case of an inhomogeneous sample.
In case of problems during the process or in case of insufficient
sample, the measuring process is aborted, as the validity of the
measuring result may be compromised.
4. When the aspiration is finished, close the inlet.
5. Measurement of the sample is performed as soon as the sample is
positioned in the measuring chambers. The measurement takes 35
seconds. Concurrent with sample analysis, the user enters patient
information as necessary.
6. When the measurement is complete, the results are computed and
then displayed on the screen and a rinse process starts. For further
information on the rinse process see page 3-6.

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3. Wet section ABL90 FLEX reference manual

Rinse process
After a measurement is complete a rinse is performed. The rinse process is the
same, no matter what kind of measurement (patient measurement, QC and
calibration) is performed. The following table describes this rinse process.

Stage Description
1 After the measurement is complete the first part of the rinse is
performed with a mixture of solutions and air.
2. The next part of the rinse is performed with a mixture of solutions
and gas.
3. Thereafter the wet section is checked. The system is filled with gas
to equilibrate the measuring chambers.
4. The entire measuring path is filled with CAL 1 (rinse) solution. The
calibration status is reestablished and the device is now ready for a
new measurement.

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ABL90 FLEX reference manual 3. Wet section

Calibration
The calibration can be divided into four kinds of calibrations:
 pO2 calibration
 pCO2, cGlu, cLac calibration
 pH, cK+, cNa+, cCa2+, cCl– calibration
 Oxi calibration

pO2 calibration pO2 is sensitivity calibrated on ambient air and status checked on CAL1. For
further information on the pO2 calibration see Calibration of the pO2 sensor in
section pO2 sensor in chapter 5 in this manual.
pO2 is sensitivity calibrated once a day and status checked with every
measurement.

pCO2, cGlu, pCO2, cGlu, cLac are sensitivity calibrated on CAL3 and status calibrated on
cLac CAL1. For further information on the pCO2, cGlu, cLac calibration, see
calibration Calibration of the pCO2 sensor in section pCO2 sensor and Calibration of the
metabolite sensors in section Metabolite sensors in chapter 5 in this manual.
pCO2, cGlu, cLac are sensitivity calibrated every four hour and status calibrated
with every measurement.

pH, cK+, cNa+, pH, cK+, cNa+, cCa2+, cCl– are sensitivity calibrated on CAL2 and status
cCa2+, cCl– calibrated on CAL1. For further information on the pH, cK+, cNa+, cCa2+, cCl–
calibration calibration, see Calibration of the pH and electrolyte sensors in section pH and
electrolyte sensors in chapter 5 in this manual.
pH, cK+, cNa+, cCa2+, cCl– are sensitivity calibrated once a day and status
calibrated with every measurement.

Oxi calibration ctHb and ctBil are sensitivity calibrated on S7770 ctHb Calibration Solution and
ctHb, ctBil and the oximetry parameters are status calibrated on a transparent
solution (CAL3) from the solution pack. For further information on the oxi
calibration, see Calibration of the optical system in section ctHb and derivates in
chapter 5 in this manual.
It is recommended that ctHb and ctBil are sensitivity calibrated (cuvette factor)
manually every three months by performing the tHb calibration. Also the
wavelength is calibrated. For further information on the ctHb calibration, see
section tHb calibration in chapter 6: Calibration in the ABL90 FLEX operator's
manual.
ctHb and the oximetry parameters are status calibrated every four hours and if
the temperature of the oximetry optical system changes to a temperature
outside drift limits.

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3. Wet section ABL90 FLEX reference manual

Automatic QC
Measuring The solution pack contains three levels of QC solution. The analyzer is designed
process to run each level once every 24 hours. However, it is possible to set up a
schedule to run QC more often, if required, as described in section QC Schedule
in chapter 1.
The QC solutions that come from pouches in the solution pack enter the sample
path through the inlet as a normal blood sample. The only difference is the
position of the inlet that remains in the closed position.
Stage Description
1. When an automatic QC is scheduled to be run, it will postpone
measurements etc., unless the analyzer is busy measuring a blood
sample. In this case, the scheduled QC will be run after the analyzer
has completed the measurement.
2. The QC measuring procedure begins:
 For QC level B only: A measurement of high oxygen is performed
on a gas from a pouch that is aspirated before the QC solution.
 Measurement of the QC solution is performed as soon as it is
positioned in the measuring chambers.
3. The result is saved in the Quality Control log.
4. The result is compared with the defined control range, measuring
range and statistics range.
5. The absence of any markings next to a parameter indicates that a
parameter was measured without any fault.
Marking Explanation
? Error in the previous calibration, or analyzer
malfunction.
W A violated Westgard Rule.
R A violated RiLiBÄK rule.
Parameter value is outside the control range, but
inside the statistics range.
Only the values within the statistics range are
considered accepted and are included in the QC
statistics.
Parameter value is outside the statistics range and
is not included in the statistics.
Parameter value is outside the range of indication.
Measurement is not included in the statistics.
* Parameter values with user-defined corrections –
see section Parameters and input setup, chapter 1
for details
….. Parameter value could not be calculated, most likely
due to a system error or malfunction. These values
will for the most part be accompanied by a "?". To
obtain a possible explanation, press Message.
6. After the measurement is complete, it is followed by a rinse. For
further information on the rinse process see page 3-6.

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ABL90 FLEX reference manual 3. Wet section

Manual QC samples
Measuring The following table describes the analytical process of a manual QC
process measurement using the manual QC option.

Stage Description
1. The analyzer is ready to accept a QC sample.
 "Ready" message is displayed
 Traffic light is GREEN or YELLOW.
The desired parameters are available
2. At the Ready screen, the user lifts the inlet handle to the syringe
position. Press Ampoule – QC.
3. The adapter is pressed against the inlet gasket and the inlet probe
extends into the sample, which is automatically aspirated.
NOTE: It is mandatory to use the adapter to minimize the risk of
possible glass pieces from the ampoule getting into the system of
the analyzer.
4. When the aspiration is finished, close the inlet. The screen is now
ready to accept QC information.
5. After the measurement is complete, it is followed by a rinse. For
further information on the rinse process see page 3-6.

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3. Wet section ABL90 FLEX reference manual

3-10
 4. Electronics

General information................................................................................. 4-2

Electronic boards and components............................................................. 4-3
4. Electronics ABL90 FLEX reference manual

General information
General The electronics of the ABL90 FLEX analyzer can be subdivided into the following
information modules:
 The user interface module which consists of a touch screen, a built-in barcode
scanner and an embedded computer module
 An integrated thermal printer
 Electronics for control of the wet section pump, valve, sensor cassette,
solution pack and flow selector
 Interface to electronic chip for solution pack identification
 Power supply unit
 Inlet positioning
 Sample mixer

Communication Communication between an external data management computer and the

analyzer may be achieved via a serial RS232 interface or Ethernet connection
via the RJ45 interface port.

4-2
ABL90 FLEX operator's manual 4. Electronics

Electronic boards and components

Power supply Universal power supply with input from 100-240 VAC, 50-60 Hz.
It includes three internal DC output levels, +5 VDC, +12 VDC, and +24 VDC,
distributed to different parts of analyzer electronics.
Power supply is prepared for battery option.

Sensor Module The Sensor module includes the Wet Section Control, Sensor Interface,
Oximetry System, Selector Detector and Cassette/Instrument ID.
Wet Section Control:
The Wet Section Control PCB handles the measurement system and takes care
of data collection and actuator controls.
It includes a microcontroller circuit, motor drivers, oximetry circuit and
barometer.
It interfaces to User Interface Module, Sensor Interface PCB, Oximetry System
(spectrophotometer and hemolyzer) and other peripheral sensor module PCB´s.
Sensor Interface:
The Sensor interface PCB handles data collection from electro-chemical and
optical sensors.
It includes high-impedance amplifiers and integrated analog-to-digital
converters to acquire sensor signals and transmit those data to Wet Section
Control.
Selector Detector:
The Selector Detector PCB handles the position detection of the selector function
in the liquid cassette.
It communicates with the Wet Section Control through an I2C interface.
Cassette / Instrument ID:
The Cassette/Instrument ID PCB handles data collection for the instrument- and
liquid cassette.
It includes a unique instrument ID and a connector to collect data from the
liquid cassette ID chip.
Oximetry System:
The oximetry system consists of a hemolyzer with cuvette and a 138-
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.

Inlet The Inlet Position with guide plate handles the detection of inlet positions and
positioning signaling LED´s.
It includes Hall detectors and an input/output port that communicates with the
Wet Section Control through an I2C interface.

User Interface The User Interface Module includes the CPU Unit, display unit and barcode
Module reader.

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4. Electronics ABL90 FLEX reference manual

CPU Unit:
The CPU Unit runs the operating system and application software.
It includes a compact ETX-PC module mounted on a baseboard that interfaces
signals to internal and external connectors.
It also includes a speaker, a fan and a solid-state disk (CF), in which all
operating system and software files are stored, along with system database
files.
Display Unit:
The display unit handles the Man Machine Interface.
It includes a 8,4” TFT display, resistive touch panel, and an Interface PCB for
LVDS signal, backlight and touch control.
Barcode Reader:
The barcode reader acts as input device for consumables, user and patient
barcodes.
It includes a laser scan engine, a proximity sensor, a buzzer, and a serial
interface.

Printer unit The 4” printer unit handles printouts of instrument and patient results.
The printer unit includes a 4” clamp shelf printer mechanism, a DC-DC converter
and a printer controller with USB interface.

Sample mixer The sample mixer detects and mixes blood samples in safePICO.
(for safePICO
It includes a mixing motor, detectors and a micro-controller that communicates
only)
with the Wet Section Control through an I2C interface.

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5. Sensors and measuring technologies

Overview ............................................................................................... 5-2

General construction ........................................................................... 5-2
General measuring principles ............................................................... 5-3
Calibration ............................................................................................. 5-4
General information ............................................................................ 5-5
The calibration equation ...................................................................... 5-6
Sensitivity ......................................................................................... 5-7
Measurement ..................................................................................... 5-8
Quality Management ........................................................................... 5-9
Reference electrode............................................................................. 5-13
Background information about the reference electrode ............................5-14
Construction of the reference electrode.................................................5-15
pH and electrolyte sensors .................................................................. 5-16
Construction of the pH and electrolyte sensors.......................................5-17
Measuring principle of the pH and electrolyte sensors .............................5-18
Calibration of the pH and electrolyte sensors .........................................5-20
Measurement – pH and electrolytes......................................................5-21
pCO2 sensor ......................................................................................... 5-22
Construction of the pCO2 sensor ..........................................................5-23
Measuring principle of the pCO2 sensor .................................................5-24
Calibration of the pCO2 sensor .............................................................5-26
Measurement – pCO2 .........................................................................5-27
pO2 sensor ........................................................................................... 5-28
Measuring principle of the pO2 sensor ...................................................5-29
Calibration of the pO2 sensor...............................................................5-30
Measurement - pO2 ............................................................................5-31
Metabolite sensors............................................................................... 5-32
Construction of the metabolite sensors .................................................5-33
Calibration of the metabolite sensors ....................................................5-34
Measurement – metabolites ................................................................5-35
Measuring principle of the metabolite sensors ........................................5-36

ctHb and derivates .............................................................................. 5-38

General information ...........................................................................5-39
Calibration of the optical system ..........................................................5-44
Correcting for interferences.................................................................5-45
Measurement and corrections..............................................................5-47
References .......................................................................................5-50
5. Sensors and optical system ABL90 FLEX reference manual

Overview

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.
Top sensor
board:

Ref K Na pCO 2 pH Cl Ca pO 2

Bottom sensor board:

Lac G lu

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ABL90 FLEX reference manual 5. Sensors and optical system

General measuring principles

Introduction There are four different measuring principles employed in the sensors in the
ABL90 FLEX analyzer.
 Potentiometry: The potential of a sensor chain is recorded using a
voltmeter, and related to the concentration of the sample (the Nernst
equation). The potentiometric measuring principle is applied in the pH, pCO2,
K+, Na+, Ca2+ and Cl— sensors.
 Amperometry: The magnitude of an electrical current flowing through a
sensor chain is proportional to the concentration of the substance being
oxidized or reduced at an electrode in the chain. The Amperometric measuring
principle is applied in the cGlu and cLac 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 containing a hemolyzed
blood sample. The specific wavelengths absorbed and their intensity
generates an absorption spectrum used to calculate oximetry parameters.
This measuring principle is used for measuring ctHb, sO2, FO2Hb, FCOHb,
FHHb, FMetHb, FHbF and ctBil.
The first three measuring principles are described under the sensors, where they
are applied. Spectrophotometry is described in the section titled ctHb and
derivates.

Activity vs. Strictly speaking, in potentiometry the potential of a sensor chain is related to
concentration the activity of a substance, and not its concentration.
The activity of a substance can be considered the "effective concentration" of a
species, taking non-ideality of the medium into account.
Activity and concentration are related by the following equation:
ax =  cx
where:
ax = the activity of the species x
 = the activity coefficient of species x under the measurement conditions
(for ideal systems  = 1)
cx = the concentration of species x (mol/L)

NOTICE: To be exact, activity is related to the molality of species x, i.e. the

number of mol/kg of solvent. However molality is converted to concentration
(molarity).

Conversion of The analyzer automatically converts activities into concentrations. The term
activity to concentration is therefore used in explanations of the measuring principles for
concentration each of the sensors further on in this chapter.

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5. Sensors and optical system ABL90 FLEX reference manual

Calibration

General information ............................................................................ 5-5

The calibration equation ...................................................................... 5-6
Sensitivity ......................................................................................... 5-7
Measurement ..................................................................................... 5-8
Quality management........................................................................... 5-9

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ABL90 FLEX reference manual 5. Sensors and optical system

General information

Definition Calibration is the process that relates the electrode signals during the calibration
sequence to the values of the calibrating solutions and air. Calibration enables
the electrode signals to be converted to the accurate values for an unknown
sample.

Frequency Calibration must be performed at regular intervals so that normal variations in

sensor output can be compensated for after inevitable minor changes in the
sensor's behavior.

Calibration Calibration of all sensors is performed using air, CAL 1 (also used for rinse), CAL
solutions 2 and CAL 3 (see chapter 9, Solutions for more information on the solutions).
The calibration solutions contain known concentrations of the substrates to be
measured. These concentrations are vital in determining the measurement
accuracy of the analyzer.
The concentration of each substance in the calibration solutions is programmed
into the integrated smart chip of the solution pack. The information is
automatically read by the analyzer when a solution pack is installed in the
analyzer.

Traceability of The traceability certificate for the solution pack is found in chapter 9 of this
calibration manual.
solutions

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5. Sensors and optical system ABL90 FLEX reference manual

The calibration equation

Definition The calibration equation expresses the relationship between the electrical
measurement at a sensor and the concentration of the substrate specific to the
sensor.

Use The calibration line forms the basis of the scale used by the analyzer to convert
electrical measurements to concentrations.

Deriving the Each sensor has a unique calibration equation.

calibration
In the following example of a potentiometric sensor, the pH sensor is used to
line
illustrate how this equation is derived from two solutions of known pH. The pH
value as graphed is a linear scale. All other electrolyte values, if graphed, would
be expressed as log10(aion).
 Solution 1 (s1) has a pH of 7.40, which gives a potential reading of 2.3 mV.
 Solution 2 (s2) has a pH of 7.03, which gives a potential reading of 20.4 mV.
These two values are plotted on a graph.
The relationship between potential and pH is linear so a line can be drawn
between the two points, as shown in the diagram below:

Scale The calibration line now forms the scale used to convert the potential measured
at the pH sensor during sample analysis to an actual pH value.

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ABL90 FLEX reference manual 5. Sensors and optical system

Sensitivity
Definition The electrode sensitivity illustrates the slope of the calibration line compared to
the slope of the theoretical electrode.
The sensitivity of the theoretical electrode is 100 % or 1.00.

Measured
potential 2-point calibration line
(mV) 96 Slope = 58.4 mV/pH
Sensitivity = 95 %

Theoretical calibration line

65.25 Slope= 61.5 mV/pH
Sensitivity = 100 %

pH
6.8 7.3

If an electrode has a sensitivity of 95 % or 0.95, its sensitivity is 5 % lower than

the sensitivity of the theoretical electrode.
The sensitivity of an electrode is calculated as:
Potential at 6.8  Potential at 7.3
Sensitivity  (%)
61.5  (7.3  6.8)

where 61.5 = sensitivity of theoretical electrode.

Each electrode has its own sensitivity limits.
The sensitivities are range checked:

pH pCO2 pO2 cK+ cNa+ cCa2+ cCl– cGlu cLac

% % % % % % % pA/mmol/L pA/mmol/L
Min. 85 60 85 85 85 85 75 100 100
Max. 105 105 110 105 105 105 105 2000 2000

Updating The calibration line slope is re-established with every calibration.

Sensitivity The slope of the calibration line is described by the sensitivity value.

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):
pH pCO2 pO2 cK+ cNa+ cCa2+ cCl– cGlu cLac
mV mV mmHg mV mV mV mV pA pA
Min. -50 -50 -20 150 150 200 -50 0 0
Max. 250 250 20 350 350 400 100 3000 3000

Drift Drift describes the variation in location of the calibration line between
consecutive calibrations. Typically, sensitivity drift is insignificant compared to
status drift. The analyzer automatically compensates for this drift by performing
a 1-point calibration with every measurement.

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5. Sensors and optical system ABL90 FLEX reference manual

Measurement

Sample A blood sample gives a potential reading of 4.8 mV at the pH sensor. Reading
measurements off from the calibration line shown below, this potential corresponds to a pH of
7.35.

Corrections To compensate for deviations from ideal behavior (ex. dilution of sample with
residual rinse solution, and change in gas level by contact with the sample
path), a correction is applied, to give the final value.
The correction is typically a linear correction, and is described for each sensor
type in the following.

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ABL90 FLEX reference manual 5. Sensors and optical system

Quality Management

Introduction This section describes the functionalities that the analyzer, apart from the built-
in quality checks, applies to ensure the measurement quality.

System/ System checks:

analysis checks
System checks are performed regularly and automatically consist of the
following checks:
 Communication checks
(to check the communication between the PC and embedded systems. Are
performed after analyzer startup.)
 Software checks
(to check the correct Data Management system (DMS) against the correct wet
section software. Are performed after analyzer startup.)
 Mechanical checks
(to check the calibration and the positioning of the flow selector and the
solution pump volume and to check for leakages. Solution pump volume and
leakage checks are performed once a day. Flow selector calibration checks are
performed with every activity)
 Electronical checks
(to check the wet section liquid transport, leak current and liquid sensor. Are
performed once a day.)
 Temperature checks
(to check the sensor array, spectrophotometer and the temperature inside the
analyzer. Are performed continuously.)
 Consumable integrity checks on time of installation
(Sensor cassette: To check the expiration date, lifetime, conditioning time and
sensitivity of all the parameters. The activities mentioned under analysis
check are also checked. These checks are performed after sensor cassette
installation.
Solution pack: To check the expiration date, lifetime and number of remaining
tests along with the correct solution pack positioning and sample flow
integrity. These checks are performed after solution pack installation.)

Analysis checks:
Analysis checks are performed in connection with analysis – be it patient sample
analysis, calibration or a QC measurement – consist of the following checks:
 Status calibrations/checks
(to check the status of the sensors a status calibration is performed on all the
sensors except on the pO2, where is status check is performed. A detailed
description of the calibrations can be found further on in this chapter under
the individual sensor types.)
 Sample integrity checks
(to check for sensor response stability, air bubbles, insufficient sample volume
and sample path obstructions. Blockages can indirect be revealed during these
checks.)
 Temperature checks
(to check the sensor array, spectrophotometer and the temperature inside the
analyzer. Are performed continuously and with every measurement.)
 Mechanical checks
(to check the pressure, solution pump and flow selector and to check for
leakages.)

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 Electronical checks
(to check the sensor impedance and leak current.)
 Measurement preparation checks
(to ensure that the analyzer, after each activity, is ready for a new
measurement.)
 Consumable lifetime checks
(To check the expiration date and lifetime of the sensor cassette. To check the
expiration date, lifetime and number of remaining tests of the solution pack.)

Software checks:
During the software check, the correct version software in the DMS is checked
against the correct version of the wet section. In case of software consistency
errors the analyzer does not allow measurements.
Communication checks:
During the communication check, the communication between the PC and
embedded systems is checked. In case of errors the analyzer automatically tries
to re-establish the connection.
Temperature checks:
During temperature checks, the temperatures of the sensors,
spectrophotometer, cuvette and barometer (internal temperature) are checked.
If a check of the continuous temperature monitoring fails the analyzer enters
the User intervention required mode that is automatically left again if the
temperature check is ok. After power on or replacements the analyzer waits for
the temperatures to be within limits. In case of temperature drift of the Oxi
spectrophotometer, an Oxi calibration is set pending and performed in
connection with a measurement, if no scheduled calibration has been
performed, thus compensating for the drift. The temperature is monitored and
logged during aspiration of sample, QC and Cal solutions.
Sensor checks:
During sensor response checks, the signal responses of the sensors are
checked. Stability errors are reported by an error message and a "?" next to the
parameter results.
During calibration checks, the calibration values of the sensors are checked to
ensure that the analyzer is ready for measurement. In case of calibration errors
(except severe fluid transport errors) the calibration is retried. The User
intervention required mode is not entered if no other severe errors are
encountered.
Mechanical checks:
During flow selector checks, the calibration/positioning of the flow selector in
the solution pack is checked. If the flow selector calibration fails, the activity is
stopped and retried. If the second calibration fails, the User intervention
required mode is entered.
During pump checks, the volume of the pump flow is checked. If the pump
calibration fails, the activity is stopped and retried. If the second calibration
fails, the User intervention required mode is entered.
Electronical checks:
During leak current checks, the leak current between the reference electrode
and the chassis is checked to detect liquid leaks in the solution pack. If the
check fails, the check is repeated. If the second check fails, the User
intervention required mode is entered.
During impedance checks, the impedance between each pH, cK+, cNa+, cCa2+,
cCl– sensor and the reference electrode is checked. The internal impedance of

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ABL90 FLEX reference manual 5. Sensors and optical system

the pCO2 sensor is also checked. If the check fails, the check is repeated. If the
second check fails, the User intervention required mode is entered.
During liquid sensor checks, the inlet, sensor and oxi liquid sensors check the
liquid transport in the wet section. The calibration of the liquid sensors is also
checked. In case a calibration fails, a rinse is performed and the system
calibration repeated. If the second calibration fails the User intervention
required mode is entered. If the solution is inhomogeneous, the refill program
will perform three retries before aborting. If a rinse, as part of another program,
fails, a new rinse is tried and the User intervention required mode is entered if
the second attempt fails. During aspiration of a sample or internal solution, the
liquid sensors check the liquid transport (both the air segments and the liquid
are expected to trig off the sensors within certain time limits). In case of errors
the activity will be aborted.
Measurement preparation checks:
A rinse is performed after each activity. With the rinse, the temperature and
homogeneity of the rinse solution is checked. In case of rinse error, a rinse will
be performed. If this rinse fails too, the User intervention required mode is
entered.
Sample integrity checks:
The pO2 check is used to check for any blockage or leak in the flow path, and,
furthermore, the pO2 sensor is checked for air in front of the pO2 sensor. In case
of any air the pO2 parameter will be marked with a ? and a corresponding error
message is given. During pO2 checks, pressure tests are performed. In case the
tests fail, the activity is retried. If this activity fails, the User intervention
required mode is entered.
Consumables checks:
During consumables check, the sensor cassette and the solution pack lifetime
and expiration date are checked by inspecting the smart chip data of the
individual consumables. In case of chip data errors the User-intervention-
required mode is entered. If the consumables are used up or have expired, the
User-action-needed mode is entered. The user has the possibility to perform a
replacement.
Apart from the checks mentioned above a flow selector check, pressure test,
refill, pump calibration and a rinse are also performed during a solution pack
replacement. Furthermore, it is checked whether the Solution pack has been
used before. In case of errors, the User intervention required mode is entered.
The user has the possibility to perform a replacement.
During a sensor cassette replacement it is also checked whether the sensor
cassette has been used before and if the minimum/maximum conditioning time
has been met. Thereafter, a pressure test, liquid sensor check, pump
calibration, rinse and a calibration of all the sensors are performed. In case of
any errors the sensor cassette is considered to be unconditioned, and the
analyzer will perform an automatic conditioning and a new calibration that
prolong the startup time to 30 minutes.
By default each of the three built-in QC will be run after replacements and
startup. If this function has been deactivated it is recommended to perform QCs
after replacements and startup.
If the solution pack and the sensor cassette have been replaced at the same
time, all the above checks will be carried out. In case of errors the User-
intervention-required or the User-action-needed mode is entered. The user has
the possibility to perform a replacement.
Furthermore some system checks are also performed after the replacement of
the solution pack and sensor cassette.

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5. Sensors and optical system ABL90 FLEX reference manual

Calibration The following additional parameters are checked:

 Sensitivity
 Status

In case of error in a scheduled calibration, a new calibration is automatically

performed.

Measurement A 1-point calibration is automatically performed with every measurement.

For pO2, which is only calibrated in one point, a calibration check is performed.
If this check fails, a new calibration is automatically performed after
measurement and used to calculate the pO2 in the measurement, or, in other
words, actually, to perform a calibration/to ensure a valid calibration.

After sensor replacement, the metabolite sensors have a significant drift in the
sensitivity. The analyzer automatically compensates for this by performing a
calibration, when needed, after every measurement that is used to calculate the
measured metabolite values.

By performing the calibration with the measurement, instead of performing

frequent calibrations, sensor drifts are reduced more effectively. As calibrations,
furthermore, only are performed when needed, the uptime, where the analyzer
is ready for measurement, is maximized.

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ABL90 FLEX reference manual 5. Sensors and optical system

Reference electrode

Background information about the reference electrode ............................5-14

Construction of the reference electrode.................................................5-15

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5. Sensors and optical system ABL90 FLEX reference manual

Background information about the reference electrode

Purpose The purpose of the reference electrode is to provide a stable, fixed potential,
against which other potential differences can be measured.
The potential at the reference electrode is not altered by the sample
composition.

Fixed potential A fixed potential is maintained at the reference electrode by the following
equilibrium reactions:

AgCl  Ag+ + Cl

Ag+ + e  Ag

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 to determine the reference potential.

Use The reference electrode is used in the measurement of pH and electrolyte

concentrations.
Contact with the sample is made via a membrane junction between the
reference electrode liquid chamber and the measuring chamber.

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ABL90 FLEX reference manual 5. Sensors and optical system

Construction of the reference electrode

Diagram

Parts and
functions Item Part Description/Function
1 Membrane Interface to the sample.
2 Electrolyte Acts as a salt-bridge solution that maintains
solution an electrical contact between the electrode
and the sample.
3 Electrode Provides the contact between the Electrolyte
solution and the electrical contact.
4 Electrical contact The point of electrical contact between the
electrode and the analyzer.
5 Housing Sensor cassette housing with integrated
reference electrode.

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5. Sensors and optical system ABL90 FLEX reference manual

pH and electrolyte sensors

Construction of the pH and electrolyte sensors.......................................5-17

Measuring principle of the pH and electrolyte sensors .............................5-18
Calibration of the pH and electrolyte sensors .........................................5-20
Measurement – pH and electrolytes......................................................5-21

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ABL90 FLEX reference manual 5. Sensors and optical system

Construction of the pH and electrolyte sensors

Diagram 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:

23 34
4

Parts and
description Item Part Description
1 Membrane Ion-selective membrane that is in direct
contact with the sample or calibration
solution and that is sensitive to a specific ion,
e.g. the H+ ions.
2 Solid-state The point of electrical and ionic contact with
contact the membrane.
3 Electrical contact The point of electrical contact between the
sensor and the analyzer.
4 Electrode base The structural platform on which the
electrode is formed.

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5. Sensors and optical system ABL90 FLEX reference manual

Measuring principle of the pH and electrolyte sensors

Potentiometric The pH and electrolyte sensors are measured according to the potentiometric
measuring measuring principle, where the potential of an electrode chain recorded at a
principle 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
illustrated in the following diagram:

2 3 4 5 6

Parts and The electrode chain describes an electrical circuit consisting of the following:
description
Item Part Function
1 Voltmeter Measures the voltage potential in the circuit.
2 Reference electrode Provides electrical connection to the voltmeter.
3 Liquid junction Point of contact between the reference sensor
and the sample.
4 Sample The unknown liquid being measured.
5 Membrane An ion-sensitive membrane, which is sensitive
to H+/electrolyte ions.
6 Solid-state contact Provides electrical connection to the voltmeter.

Electrode chain Every element in the electrode chain contributes a voltage to the total potential
potential drop through the chain. Thus:
 When immersed in the appropriate electrolyte solution, both electrodes exhibit
separate potentials
 The membrane junctions between the sample and electrolyte solutions also
exhibit separate potentials
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 on next page.

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ABL90 FLEX reference manual 5. Sensors and optical system

Element Potential Symbol

Reference electrode Known and constant when the Eref
Ag/AgCl is immersed in the
electrolyte solution.
Liquid junction between the Known and constant. ELJ
electrolyte solution in the Independent of sample
reference electrode and the composition.
sample
Ion-sensitive membrane Unknown. Dependent on sample ESample
separating the sample and composition.
the pH sensor
Solid-state contact Known and constant. EE
Total potential Measured by the voltmeter. Etot

Unknown The unknown potential difference across the ion-sensitive PVC membrane is the
potential difference between the measured total potential and the sum of the known
potentials:
Esample=Etotal Eref ELJ EE 

Ion-sensitive The potential difference across the membrane arises as a consequence of a

membrane change in the charge balance at the membrane.
The membrane is sensitive to H+/electrolyte ions in that it has an ion exchange
ability. Since the internal solid-state reference electrode fixes the internal
potential, changes in the external charging of the membrane produce
measurable changes in the overall potential.

Nernst Having measured the unknown potential (Esample), the potential difference across
equation the membrane in the sensor can be expressed by the Nernst equation:
RT
Esample  E0   ln ax
nF
where:

E0 = Standard 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

Activity and As shown in the equation above, measuring the potential of each of the
concentration electrode chains gives a reading of the activity of the ions in the sample.
Activity expresses the "effective concentration" of a species and is explained in
more detail in the section General measuring principles earlier in this section.
The activity of the ions is automatically converted to a concentration value by
the analyzer.
The relationship between activity and concentration is explained in the section
General measuring principles at the beginning of this chapter.

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Calibration of the pH and electrolyte sensors

Introduction The pH and electrolyte sensors are calibrated by determining the E0 and
sensitivity from 2-point calibrations. Slight variations in sensor performance
between calibrations are addressed by performing a measurement of CAL 1
within every sample measurement process.

2-point A 2-point calibration is performed at preset intervals using two solutions from
calibration the solution pack. The precise values for these solutions are contained in the
smart chip located on the solution pack.

Calibration The pH and electrolyte values for CAL 1 and CAL 2 are as follows (approximate
levels values):

Level
Substance Unit CAL 1 CAL 2
pH - 7.3 6.8
cNa+ mmol/L 150 70
+
cK mmol/L 4 10
–
cCl mmol/L 95 50
cCa2+ mmol/L 0.5 2.3

The solution pH and electrolyte values are known and contained in the solution
pack smart chip.

Calibration The sensitivity is calculated in the following way and expressed as the
percentage of the theoretical sensitivity, calculated from the sensor signal of the
two calibration solutions (mV) and the nominal calibration values:

pH:
mVcal2  mVcal1
S
61,5mV  (pHcal2  pHcal1 )

Electrolyte sensors:

n(mVcal2  mVcal1 )
S
c
61,5mV  log10 ( cal2 )
ccal1

where n is the ionic charge.

Status is defined as the sensor signal of CAL 1 (rinse): mV1.

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Measurement – pH and electrolytes

Measurement The pH value measured from the sample is calculated as follows, from the
sensor signal of the sample mVsample:

mVsample  mVcal1
pH  pHcal1 
61,5mV  S

The electrolyte concentration in a sample is calculated from the following

equations:
n(Esample -Ecal1 )

c  ccal1  10 61,5mV×S

where n is the ionic charge.

The measured value is applied a linear correction:

cdisplayed  k1  c  k 2

NOTICE: cCl– is compensated for cHCO3– interference by using the measured

pH and pCO2, before the linear correction is applied.

Checks The following parameters are range checked:

 Sensitivity
 Sensitivity drift
 Status
 Sensor response stability

The sensor response stability is defined as the standard deviation of the last 5
updatings of the response.

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pCO2 sensor

Construction of the pCO2 sensor ..........................................................5-23

Measuring principle of the pCO2 sensor .................................................5-24
Calibration of the pCO2 sensor .............................................................5-26
Measurement – pCO2 .........................................................................5-27
Corrections – pCO2 ............................................................................5-27

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Construction of the pCO2 sensor

Diagram

Parts and
description Item Part Description
1 Silicone membrane A membrane separating the sample and the
electrolyte solution. Is only permeable to CO2.
2 Electrolyte solution A solution separating the silicone membrane and
the pH membrane, Ag/AgCl sensors. The
electrolyte solution is vented by CO2 whereby pH
is changed.
3 pH membrane H+ sensitive membrane.
4 Reference Ag/AgCl electrode
5 Solid-state contact The point of electrical contact between the pH
for the pH system membrane and the analyzer.
6 Solid-state contact The point of electrical contact between the
for the Ag/AgCl reference electrode and the analyzer.
system
7 Electrode base The structural platform on which the electrode is
formed.

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Measuring principle of the pCO2 sensor

Electrode chain The electrode chain (or electrical circuit) set up to measure pCO2 is illustrated in
the following diagram:

Parts and The electrode chain describes an electrical circuit consisting of the following:
description
Item Part Description
1 Voltmeter Measures the voltage potential in the
circuit.
2 pH electrode Provides electrical connection to the
voltmeter
3 Electrolyte solution Medium for connection
4 Internal reference electrode Provides electrical connection to the
(Ag/AgCl) voltmeter

Electrode chain The potential differences at all the junctions in the electrode chain are known
potential and constant, except that at the pH-sensitive membrane. (See the section pH
and electrolyte sensors for a full explanation.)
The potential difference at the pH-sensitive membrane depends on the pH of the
electrolyte solution, which in turn depends on the CO2 content of the sample.
This is explained in the measuring process below.

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ABL90 FLEX reference manual 5. Sensors and optical system

Measuring The following is an account of the measuring process in the pCO2 sensor.
process
Part Function
Transport of CO2 CO2 from the sample permeates the membrane.
Dissolution of CO2 The CO2 dissolves in the electrolyte solution.
This produces carbonic acid:
H2O + CO2  H2CO3
Dissociation of Carbonic acid dissociates according to the following
carbonic acid equilibrium reaction:
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
potential membrane creates a potential difference across the
membrane.
This change in potential across the membrane is
measured by the voltmeter.
Relation of pH to The pH value is related to the partial pressure of CO2 in
pCO2 the sample by the following equation:

pH = pK a+ log
HCO 
-
3
 * pCO2
where:
pKa = log Ka, the equilibrium constant for the
dissociation of carbonic acid in water
 = 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 and ultimate dissociation of
carbonic acid mentioned above.
If [cHCO3–] and  in the electrolyte solution is constant
this results in the following:
pH = K - log pCO2

Where
K contains the equilibrium constant pKa, the
solubility coefficient  and the concentration of
bicarbonate [cHCO3–].

E = E'0 - 61.5 × pH = E0 + 61.5 × log pCO2

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Calibration of the pCO2 sensor

Introduction The pCO2 sensor is calibrated by determining the sensitivity from 2-point
calibrations. Calibration measurements are performed on two levels of solution.
Slight variations in sensor performance between calibrations are addressed by
performing a measurement on CAL 1 within every sample measurement
process.

Calibration The ABL90 FLEX analyzer is equipped with a solution pack. This pack contains
levels 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.

Sensitivity The sensitivity is calculated in the following way and expressed as the
percentage of the theoretical sensitivity, calculated from the sensor signal of the
two calibration solutions (mV) and the nominal calibration values:

mVcal2  mVcal1
S
pCO2 (cal2)
61,5mV  log10 ( )
pCO2 (cal1)

Status is defined as the sensor signal of CAL 1 (rinse): mV1.

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Measurement – pCO2

Measurement 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 a linear correction:

cdisplayed  k1  c  k 2

Checks The following parameters are range checked:

 Sensitivity
 sensitivity drift
 status
 sensor response stability

The sensor response stability is defined as the standard deviation of the last 5
updatings of the response.

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pO2 sensor

Measuring principle of the pO2 sensor ...................................................5-29

Calibration of the pO2 sensor...............................................................5-30
Measurement – pO2 ...........................................................................5-31

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Measuring principle of the pO2 sensor

Optical system The optical system for pO2 is based on the ability of O2 to reduce the intensity
for pO2 and time constant of the phosphorescence from a phosphorescent dye that is in
contact with the sample.
The optical system for measuring pO2 is shown in the following diagram:

Measuring The green LED emits light, which is reflected by a dichroic mirror onto the pO2
sequence 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. The calculation of the pO2 is performed.

Calculations The pO2 is calculated on the basis of the Stern-Volmer equation, which describes
the relationship between the phosphorescence intensity/time constant () and
the pO2 value in a sample:

 
pO2 ( )  k   0  1 
 

where k and 0 are constants.

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Calibration of the pO2 sensor

Introduction The pO2 sensor is calibrated to determine its sensitivity by measuring one
calibration point during a sensitivity calibration process. Performance of the
sensor from calibration to calibration is checked and during sample or quality
control analysis any drift on sensitivity is checked. The pO2 sensor is calibrated
on ambient air.

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)

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
pressure of saturated air at 37 oC, and p(amb) is the barometric pressure.

Status In connection with the sensitivity calibration performed on ambient air, also the
CAL1 (rinse) solution is measured to obtain a status. This status aims to check
the performed calibration. This is done by comparing the measured value of the
CAL1 (rinse) solution to the reference value of CAL1, given by the smart chip):
pO2 (status,cal)  pO2 (CAL1,cal)  pO2 (CAL1,ref)

For every measurement, the pO2 calibration is checked by comparing the

measured value of CAL1 (rinse) solution to the value obtained on the CAL1
solution of the last calibration (CAL1CAL):
pO2 (status,meas)  pO2 (CAL1,meas)  pO2 (CAL1,cal)

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Measurement - pO2
On whole 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 a 2nd order blood correction, to compensate for
the varying buffer value of blood, as a function of pO2 tension. A second-order
correction is applied:

pO2 (display)  k1 pO22  k 2 pO2 + k 3

NOTICE: During a measurement, the sensor technology used offers detection of

any air bubble in front of the pO2 sensor that could lead to significant errors.

Checks The following parameters are range checked:

 Sensitivity
 Sensitivity drift
 Status

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Metabolite sensors

Construction of the metabolite sensors .................................................5-33

Calibration of the metabolite sensors ....................................................5-34
Measurement – metabolites ................................................................5-35
Measuring principle of the metabolite sensors ........................................5-36

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Construction of the metabolite sensors

Basic The cGlu and cLac sensors are three-electrode sensors consisting of an internal
description 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.
The membrane consists of four layers:
 The biocompatible layer
 The outer membrane – permeable to cGlu/cLac
 The enzyme layer
 The inner membrane – permeable to H2O2

Diagram

Parts and
description Item Part Description
1 Biocompatible Biocompatible layer
layer
2 Outer membrane Outer membrane permeable to glucose –
diffusion control
3 Enzyme layer Contains glucose/lactate oxidase.
4 Inner membrane Cellulose acetate.
5 Reference Ag/AgCl electrode.
6 Anode Platinum electrode.
7 Cathode Platinum electrode.
8 Electrode base The structural platform on which the sensor is
formed.

Zero current The zero current is a small background current measured at the electrode when
no cGlu/cLac is present in a solution. As CAL 1 contains no cGlu/cLac, a baseline
representing the zero current, I0 as a function of time (I0 = f(t)), is obtained
from continuous measurements on CAL 1.
This I0 baseline is obtained as follows:
 At the end of a rinse, with CAL 1 in the measuring chamber, the zero
current of the metabolite electrodes is measured periodically
 The previous N (N = 8) measurements on the CAL 1 – before a calibration
or a sample measurement starts – are used to obtain a baseline
representing the time function of I0

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 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

Calibration of the metabolite sensors

Sensitivity The sensitivity of the cGlu and cLac sensors is calculated by measuring the
current from CAL 3 then subtracting the zero current as measured from CAL 1.
CAL 3 has a nominal glucose concentration of 10 mmol/L and a nominal lactate
concentration of 10 mmol/L. The precise values are specific to the individual lot
of the solution pack and are contained in the solution pack smart chip.
The current at the cGlu and cLac sensors with CAL 3 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 cGlu or cLac sensor.

The sensitivity of the cGlu or cLac sensor is calculated as follows:

Ical3  I0
S
ccal

where I0 is the zero current estimated to the time of measurement from the 8
samples taken on CAL 1 (rinse).
Status is defined as I0.

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Measurement – metabolites

Measurement The glucose or lactate concentration in a sample is calculated from the following
equation, using the difference between the current in the sample and the
extrapolated zero current from the rinse solution:
Isample  I0
c
S

The measured value is applied a linear correction:

cdisplayed  k1  c  k 2

NOTICE: cLac is compensated for the dependence of the ionic composition by

using the measured electrolyte values before the linear correction is applied. If
the electrolytes are not measured, default values are used.

Checks The following parameters are range checked:

 Sensitivity
 Sensitivity drift
 Sensor response stability

The sensor response stability is defined as the standard deviation of the last 5
updatings of the response for CAL 1 (rinse).
For CAL 3, it is defined as the standard deviation of a linear regression for the
last 5 samples, normalized with the signal magnitude.

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Measuring principle of the metabolite sensors

Amperometric The cGlu and cLac sensors are measured according to the amperometric
measuring measuring principle, in which the magnitude of an electrical current flowing
principle through an electrode chain is related to the concentration of a substance being
oxidized or reduced at an electrode in the chain.

Electrode chain The electrode chain set up to measure glucose/lactate is illustrated in the
following diagram1:

Parts and The electrode chain describes the electrical circuit consisting of the following:
functions
Item Part Description
1 Amperemeter Measures the current flowing through the circuit in
nanoamperes.
2 Cathode Negative electrode where a reduction reaction
occurs and electrons are consumed.
3 Membrane Allows the appropriate molecules to pass through
from the sample.
4 Sample Contacts the membrane.
5 Electrolyte Provides electrical contact between the anode and
cathode.
6 Anode Positive electrode where an oxidation reaction
occurs and electrons are released.
7 Applied voltage Applies the necessary potential for the reduction or
oxidation reaction under study.

1
Note that polarization voltage is applied between the anode and the reference
electrode (not shown). The current runs through the anode and cathode chain.

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Measuring A constant polarization voltage is applied to the electrode chain. The current
process through this chain is measured by an amperemeter.
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 the following reactions:
Glucose: Glucose + H2O + O2  Gluconic Acid + H2O2

Lactate: Lactate + H2O + 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, consuming 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 can also occur at the cathode.)
Any of these three reactions at the cathode will serve to neutralize the protons
generated in the second reaction, so the total change in acidity is caused by the
gluconic acid/pyruvate only.

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ctHb and derivates

General information ...........................................................................5-39

Calibration of the optical system ..........................................................5-44
Correcting for interferences ................................................................5-45
Measurement and corrections..............................................................5-47

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General information

Measured The optical system of the ABL90 FLEX analyzer is designed to measure the
parameters following 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

NOTICE: ctBil can be measured on a whole-blood or plasma sample. 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 138-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.

Spectrophotometer

Array of
photodiodes

Grating

Mirrors

Slit

Optical
Hemolyzer Hemolyzing
fiber
unit
cable

LED light
source

Cuvette

Sample

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Measurement The method used in the analyzer's optical system is visible absorption
cycle spectroscopy. The measurement cycle consists of the following steps:

Step Description
1 The blood sample is transported to the cuvette positioned in the
hemolyzer unit. The temperature of the cuvette is regulated to 37 °C.
2 A back pressure is exerted on the sample. This one atmosphere
over-pressurization is maintained throughout the hemolyzation and
measurement to eliminate air bubbles in the sample and to enhance
the hemolyzation process.
3 The one-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, evenly mixing the content of the red
blood cells with the plasma and producing an optically clear
solution.
4 Light from a white LED is emitted to the cuvette and the light
transmitted through the cuvette is guided to the spectrophotometer via
an optical fiber.
5 The light passes through a slit that directs it towards an
arrangement of mirrors and a grating.
6 The grating separates the light into the colors of the rainbow and
the mirror focuses the light on a photodiode array.
7 The photodiode array has 256 diodes or pixels, one for each
wavelength, which convert the monochromatic light signals to
currents.
8 The currents and therefore the intensity of the light signals are
measured at each of the 256 diodes, which form the basis for the
absorption spectrum for a particular sample.
9 The spectrum is sent to the analyzer’s computer, where the
calculations of the oximetry parameter values are made.
The 256 channels are standardized into 138 selected wavelengths.

Lambert-Beer's Absorption spectroscopy is based on Lambert-Beer's law, which states that the
law measured absorbance for a single compound is directly proportional to the
concentration of the compound and the length of the light path through the
sample [2]:

Ay   y  cy  l
where:
Ay = absorbance of compound y at wavelength 

 y = extinction coefficient of compound y at wavelength (a constant,

characteristic of the compound)
cy = concentration of compound y in sample
l = length of the light path

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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:

I0 = 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 For samples containing more than one optically active compound, the total
absorbance absorbance (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 1 is:
1
Atotal  Ay1  Ay1  Ay1  Ay1  Ay1  Ay61
1 2 3 4 5


 l  y1 cy1   y1 cy2   y1 cy3   y1 cy4   y1 cy5   y1 cy6
1 2 3 4 5 6

If there are Y compounds and measurements are taken at n wavelengths, a
general expression can be written for Atotal at the wavelength n:
Y
n
Atotal    yn  cy  l
y 1
where:
n = the individual wavelengths.

Continuous n
Atotal can be depicted graphically as a function of wavelength, and if the
spectrum
differences between the wavelengths are small enough, a continuous spectrum
is produced.

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Spectrum The figure below shows three spectra; pure O2Hb, pure HHb in a low
examples concentration, a spectrum of 92 % oxygenated hemoglobin obtained by adding
the spectra of O2Hb and HHb. The additivity of absorption and the continuity of
the spectra can be seen.

Absorption

480 500 520 540 560 580 600 620 640 660 680
Wavelength/nm
O2Hb (9.2 mmol/L)
HHb (0.8 mmol/L)
92 % oxygenated hemoglobin (i.e., 92 % O2Hb + 8 % HHb)

Example of the spectrum obtained from unconjugated bilirubin at a

concentration of 200 µmol/L.

200um ol/L U nco nju gated B iliru bin in P lasm a

0.1

0.08
Absorba nce

0.06

0.04

0.02

0
470 520 570 620 670
nm

The spectrum of conjugated bilirubin is slightly different.

Determining In the spectrum taken of a sample, the absorption recorded at each wavelength
concentrations 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 using the following equation:

138
cy   K yn Atotal
n

n 1
where:
K yn = a constant specific to compound y at wavelength n.

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Matrix of The constants ( K yn ) are determined using Multivariate Data Analysis 2 where
constants
the spectra of the calibration compounds are considered together with the
reference values of the calibration compounds. The essential interfering
substances (intralipids and sulfhemoglobin) were also taken into account.

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Calibration of the optical system

Calibration The optical system is calibrated at two points using the following:
materials
 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 calibrated to this zero point.

Io is measured automatically during system start up and during calibrations.

Cuvette path The cuvette path length (i.e. the length of the light path) is determined from
length 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 x l

where:
A = absorbance
ε = extinction coefficient
Cdye = concentration of colored dye
l = length of light path

tHb calibration It is recommended that a tHb calibration is performed every three months. See
frequency section tHb calibration in chapter 6: Calibration in the ABL90 FLEX operator's
manual for further information about the tHb calibration.

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Correcting for interferences

HbF versus Fetal hemoglobin (HbF) does not have the same spectrum as adult hemoglobin
HbA (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 performed.
It is thus important when measuring hemoglobin levels in premature neonates and
neonates aged 0-3 months, as well as adults suffering from e.g. thalassemia, to
take into account this difference [4], and the ABL90 FLEX analyzer automatically
corrects for HbF.
NOTICE: Hb types other than HbA and HbF interfere with hemoglobin
measurements and are not compensated for in the ABL90 FLEX analyzers.
The diagram below shows the transition from fetal hemoglobin to adult
hemoglobin [5].

This graph is only schematic and cannot be used to determine FHbF.

Deviation of If the difference between the adult and fetal types of hemoglobin is not taken
results into account in measurements on samples containing HbF (e.g. from premature
neonates and neonates aged 0-3 months) then a deviation in the measurement
will arise.
The deviation is most important for measurements of oxygen saturation (sO2
and FO2Hb) and the fraction of carboxyhemoglobin (FCOHb), since inaccurate
measurements 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 from the difference spectrum
between fetal and adult oxyhemoglobin. From the size of the difference
spectrum the concentration of fetal oxyhemoglobin, cO2HbF, can be determined.

Correcting for The amount of cO2HbF exceeding a certain level indicates HbF interference. The
HbF analyzer automatically corrects for this interference by subtracting the
difference spectrum of fetal oxyhemoglobin from the measured spectrum.

Repressing Repressing the spectra of the likely interfering substances is done in two ways
spectra 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 The measured spectrum is compared to a model spectrum calculated from the
spectrum determined 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 the following
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%

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Measurement and corrections

Oximetry The oximetry parameters are calculated as follows:

parameters
Parameter Equation
ctHb(meas)  cO2Hb + cCOHb + cHHb + cMetHb
cO2Hb

sO2 ceHb
ceHb = cHHb + cO2Hb (effective hemoglobin)
cO2Hb

FO2Hb ctHb
cCOHb

FCOHb ctHb
cHHb

FHHb ctHb
cMetHb

FMetHb ctHb

FHbF cHbF
=
ctHb

where:

cO2Hb = concentration of oxyhemoglobin in the sample

cCOHb = concentration of carboxyhemoglobin in the sample
cHHb = concentration of deoxyhemoglobin in the sample
cMetHb = concentration of methemoglobin in the sample
cHbF = concentration of fetal hemoglobin in the sample (is not measured
directly, but determined on the basis of a definition equation)

Bilirubin Bilirubin is calculated as follows:

ctBil(B)
ctBil(P) 
1  Hct(calc)

where:

ctBil(P) = concentration of total bilirubin in plasma

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 explanation of MCHC (Mean Corpuscular
Hemoglobin Concentration) in chapter 7 in this manual.

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Restrictions The following parameters will not be calculated:

Parameter Is not calculated if…

sO2, FCOHb, FMetHb, ctHb < 1 mmol/L
FHHb, FO2Hb
sO2 ceHb = cHHb + cO2Hb < 0.75 mmol/L
ctBil ctHb > 14.27 mmol/L

The following conditions are required to perform HbF suppression:

Parameter or Feature Requirement

ctHb > 5 mmol/L
FCOHb < 20 %
FMetHb < 10 %
HbF correction – cO2HbF/ctHb should be more than 0.2.
Enabled for levels
>20%
HbF correction – No lower limit value for cO2HbF is required, i.e.
Enabled for all levels even adult blood samples will be corrected for HbF.
It may be of value when analyzing 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 – No HbF corrections made.
Disabled
HbF suppression has The FHbF value is normally, but not always,
been activated displayed by the analyzer.
Message "Oxi compensated for HbF" is displayed.
sO2 < 50 % Message "FHbF measurement is not possible" is
displayed by the analyzer, if a HbF suppression has
been activated, and the FHbF estimation from
cO2HbF is too uncertain.

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Corrections for The uncorrected hemoglobin concentration, ctHb(sample), measured on

ctHb capillary or syringe samples is corrected as follows:

ctHb(sample)
ctHb(sample,corr) 
Fcuv
where:

ctHb(sample,corr) = corrected ctHb

Fcuv = analyzer-dependent cuvette path length constant
determined at tHb calibrations and automatically
stored by the analyzer

Corrections for The uncorrected total bilirubin concentration, ctBil(sample), measured on

ctBil capillary or syringe samples is corrected as follows:

ctBil(sample)
ctBil(sample,corr) 
Fcuv
Fcuv is the same as for tHb.

5-49
5. Sensors and optical system ABL90 FLEX reference manual

References

1. CLSI/NCCSL document C12-A, Clinical and Laboratory Standards Institute, 940 West
valley Road, Suite 1400, Wayne, PA 19087.
2. Ewing GW. Instrumental methods of chemical analysis. 5th ed. McGraw.Hill, 1985
3. Martens H. Multivariate calibration: quatitative interpretation of non-selective
chemical data: Dr. Techn. Thesuis. NTH Univ. of Trondheim, 1986.
4. Krzeminski A. Why correct for fetal hemoglobin in blood oximetry measurements?
Radiometer Publication Info. No. 1992-3. Copenhagen: Radiometer Medical A/S,
1992.
5. Huehns ER, Beanen GH. Developmental changes in human hemoglobins. Clin Dev Med
1971; 37: 175-203.

5-50
 6. User-defined corrections

General information................................................................................. 6-2

Correction factors for pH and blood gases ................................................... 6-4
Correction factors for oximetry parameters ................................................. 6-5
Correction factors for electrolyte and metabolite parameters ......................... 6-8
6. User-defined corrections ABL90 FLEX reference manual

General information
Purpose of use User-defined corrections are most commonly implemented in situations where
the values measured for a particular parameter by two or more analyzers
deviate consistently from each other.
NOTICE: Since the performance of all ABL90 FLEX analyzers is tested as
described in chapter 7: Performance characteristics in this manual, and each
instrument is assumed to operate accurately and optimally, the unnecessary
correction of parameter values by the user can lead to inaccurate measurements
being reported.

User-defined User-defined corrections are based on a linear correlation between the

corrections measured values (without user-defined corrections) and the displayed values
(with user-defined corrections).
The correction factors for each measured parameter are the slope and the offset
of the correction line. With user-defined corrections it is possible to change the
values of either one or both of these correction factors, depending on the
parameter type.
Corrected value = Slope × Uncorrected value + Offset
The diagram below is a schematic representation of the relationship between
correction lines without and with user-defined correction.

Correction line with

user correction
Displayed (corrected)
parameter value (y axis)
Correction line without
user correction

Slope = 1

Offset

Measured
(uncorrected)
parameter value
0.0 (x axis)

Preparatory Prior to entering corrections for any parameter, the user must obtain the
action reference values for the chosen parameters, using the method accepted in
his/her laboratory.

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ABL90 FLEX reference manual 6. User-defined corrections

It should be noted that in order to define corrections:

 Measurements should be taken on the ABL90 FLEX analyzer without user-
defined corrections, and on a single reference analyzer
 A series of measurements that cover the entire measuring range should be
performed
 The measurements should be made simultaneously on the ABL90 FLEX and
the reference analyzer, and samples must be handled correctly.
 The slope and the offset must be calculated. The user may, for example,
make a linear correlation between the values measured on the ABL90 FLEX
analyzer and the reference analyzer, using the ABL90 FLEX analyzer as an
independent variable.
 The user must verify the corrections that are entered.
Details of these procedures may be found in the section Test conditions in
chapter 7.

Entering user- The slope/offset for each parameter are configured in General Setup >
defined Parameters and Input > Parameters. User-corrected values are marked with
corrections a "*" after the result.
NOTICE: The user-defined corrections will be applied to Quality Control
measurements unless the "Apply parameter corrections to QC" option was
deactivated in Miscellaneous setup as described in the section Miscellaneous
setup in chapter 1.
For detailed instructions on how to enter user-defined corrections, refer to the
section Parameters and input setup in chapter 1.

6-3
6. User-defined corrections ABL90 FLEX reference manual

Correction factors for pH and blood gases

Correcting The following corrections to the slope and offset are possible within the stated
slope and limits for:
offset
–
Arterial, venous, and a-v samples:
Parameter Slope Offset
pH 0.80-1.20 0.05
pCO2 0.80-1.20 10 mmHg
pO2 0.80-1.20 20 mmHg

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ABL90 FLEX reference manual 6. User-defined corrections

Correction factors for oximetry parameters

Allowed The following corrections can be user-defined for the oximetry parameters:
corrections

Parameter Allowed user-defined

corrections
Slope Offset
ctHb Yes No
sO2 Yes Yes
FCOHb No Yes
FMetHb No Yes
FO2Hb No No
FHHb No No
FHbF Yes Yes
ctBil Yes Yes

NOTICE: In order to define the corrections accurately the measurements of the

oximetry parameters on the ABL90 FLEX analyzers should be made without any
entered corrections. To avoid truncation errors from an enabled "Out-of-range-
suppression" function it is important to disable the function.

The following recommendations apply to the oximetry parameters:

ctHb Item Description

Units g/dL; g/L; mmol/L
Sample Set ctHb of a SAT100 sample to 15 g/dL (9.3 mmol/L) and
pH  7.4
ctHb, maximum Uncorrected or corrected:  15 g/dL or 9.3 mmol/L
point
Slope 0.950-1.050

sO2 Item Description

Units Fraction
Sample Set ctHb of gas equilibrated SAT0 and SAT100 samples to 
15 g/dL (9.3 mmol/L) and pH  7.4
Slope 0.900-1.100
Offset 0.050

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6. User-defined corrections ABL90 FLEX reference manual

FCOHb Item Description

Units Fraction
Sample The zero point (FCOHb  0) is saturated to approximately
SAT100, and ctHb is set to  15 g/dL (9.3 mmol/L) and pH 
7.4.
Offset 0.050

FMetHb Item Description

Units Fraction
Sample The zero point (FMetHb  0) is saturated to approximately
SAT100, and ctHb is set to  15 g/dL (9.3 mmol/L) and pH 
7.4.
Offset 0.050

FHbF Item Description

Units Fraction
Sample Radiometer recommends that ctHb in the adult samples
(with FHbF = 0) and fetal samples (with high FHbF) is set to
 15 g/dL (9.3 mmol/L), sO2  100 % and pH  7.4.
The "Enabled for all levels" HbF Correction function should
be enabled in order to have the FHbF value displayed for the
adult sample.
Averaging repeated measurements on blood from different
donors gives an optimized accuracy of the correction.
Averaging repeated measurements on blood from the same
donor also improves the accuracy.
Slope 0.800-1.200
Offset 0.20

FO2Hb and The units for FO2Hb and FHHb are Fraction.
FHHb
After the user-defined corrections of the parameters sO2, FCOHb and FMetHb
have been carried out, FO2Hb and FHHb are automatically calculated using the
formulae stated below, since the sum of the fractions FCOHb, FMetHb, FO2Hb
and FHHb as defined must be equal to 1.0:

FO2Hb:
FO2Hb = (1  FCOHb  FMetHb)  sO2

FHHb:
FHHb = (1  FCOHb  FMetHb)  (1  sO2)

6-6
ABL90 FLEX reference manual 6. User-defined corrections

ctBil The following recommendations apply to ctBil:

Item Description
Units mol/L
Sample Radiometer recommends that human plasma or serum is
used with pH  7.4 (the analyzer reading). Zero point
sample could be adult sample (ctBil  0 mol/L) and
maximum point could be an unconjugated bilirubin sample
(neonatal) with ctBil  300-400 mol/L.
Averaging repeated measurements on samples from
different donors gives an optimized accuracy of the
correction. Averaging repeated measurements on samples
from the same donor also improves the accuracy.
Commercial bilirubin standards can interfere with bilirubin
measurement because they may have an absorbance
spectrum different from that of human plasma.
Slope 0.500-1.500
Offset 100

6-7
6. User-defined corrections ABL90 FLEX reference manual

Correction factors for electrolyte and metabolite

parameters
Correcting The following corrections to the slope and the offset are possible within the
slope and stated limits for:
offset
Blood samples:
Parameter Slope Offset
cK+ 0.80-1.20 1.0 mmol/L
+
cNa 0.80-1.20 10 mmol/L
2+
cCa 0.80-1.20 1.00 mmol/L
cCl– 0.80-1.20 10 mmol/L
cGlu 0.750-1.250 5.0 mmol/L
cLac 0.750-1.250 5.0 mmol/L

Resetting The Radiometer default values for the electrolyte and metabolite parameters
corrections to must be reset manually by the user on the Parameter setup screen to 1.000
default values for each parameter.

6-8
 7. Performance characteristics

General information ................................................................................. 7-2

Definition of terms................................................................................... 7-3
Test conditions........................................................................................ 7-6
Performance test results – chart description ................................................ 7-7
Performance test results – pH ................................................................... 7-8
Performance test results – pCO2 ................................................................ 7-8
Performance test results – pO2 .................................................................. 7-9
Performance test results – cK+ .................................................................. 7-9
Performance test results – cNa+ .............................................................. 7-10
Performance test results – cCl– ................................................................ 7-10
Performance test results – cCa2+ ............................................................. 7-11
Performance test results – cGlu ............................................................... 7-11
Performance test results – cLac ............................................................... 7-12
Performance test results – ctHb............................................................... 7-13
Performance test results – sO2 ................................................................ 7-14
Performance test results – FO2Hb ............................................................ 7-15
Performance test results – FCOHb............................................................ 7-15
Performance test results – FMetHb........................................................... 7-16
Performance test results – FHHb.............................................................. 7-17
Performance test results – FHbF .............................................................. 7-17
Performance test results – bilirubin .......................................................... 7-18
Interference tests.................................................................................. 7-20
7. Performance characteristics ABL90 FLEX reference manual

General information
Performance specifications are achieved by comparison between the ABL90 FLEX
analyzer and the primary reference methods, and by comparison between the ABL90
FLEX analyzer and the ABL735 analyzer.
Performance specifications of the ABL90 FLEX analyzers are described, using the
following:
 BiasPrim.ref = the mean difference between the ABL90 FLEX analyzer and the primary
reference methods.
 BiasSec.ref = the mean difference between the ABL90 FLEX analyzer and the ABL735
analyzer.
 Repeatability (imprecision estimate)
 Reproducibility (imprecision estimate)
 Total variation range.

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ABL90 FLEX reference manual 7. Performance characteristics

Definition of terms
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
reference method or certified standard reference material). BiasPrim.Ref is determined as
follows:

BiasPrim.ref = X ABL90 FLEX  X Primary Reference method

BiasSec.Ref is a relative bias between the ABL90 FLEX analyzer and the ABL735 analyzer
in macromode (C195 µL mode), and is determined as follows:

BiasSec.ref = X ABL90 FLEX  X ABL735

Bias given in the tables in this chapter have been obtained experimentally.

Secondary
Reference
Parameter Primary Reference Method Reference Reference
methods
Method
pH Capillary-type glass pH electrode ABL735 [Ref. 1,2]
with a saturated calomel reference
electrode and a liquid junction
saturated with KCl (BMS Mk2).
The calibration standards are
traceable to the Primary Reference
Standards for pH.
pCO2 Tonometry. N/A [Ref. 3]
The gases used for tonometry are
traceable to NIST-certified Standard
Reference Materials.
pO2 Tonometry. N/A [Ref. 3]
The gases used for tonometry are
traceable to NIST-certified Standard
Reference Materials.
cCa2+ Calcium transfer standards were ABL735 The
used. These are traceable to NIST standards
SRM 915 and SRM 956b and have were
an ionic strength of 160.0 mmol per produced as
kg of water and pH 7.40 at 37 °C, indicated in
using 1 mmol/L (37 °C) HEPES [Ref. 4]
buffer.
cCl- NIST-certified Standard Reference ABL735
Material SRM 909b (human serum)
and SRM 956b.
cK+ NIST-certified Standard Reference ABL735
Material SRM 909b (human serum)
and SRM 956b.
cNa+ NIST-certified Standard Reference ABL735
Material SRM 909b (human serum),
NIST 956b and Radiometer-specified
standard serum material (specified
using flame photometry).

7-3
7. Performance characteristics ABL90 FLEX reference manual

Secondary
Parameter Primary Reference Method Reference Reference
Method
cGlu Spectrophotometry, using the N/A [Ref. 5]
hexokinase (HK) method
recommended by NCCLS, measured
on serum.
cLac Spectrophotometry using a lactate N/A [Ref. 8]
dehydrogenase (LDH) method,
measured on serum.
ctHb HiCN method recommended by ABL735 [Ref. 6]
NCCLS.
sO2 Tonometry: ABL735
100%: whole blood is tonometered
with a gas mixture containing
94.4% O2 and 5.6% CO2. 0%:
whole blood is tonometered with a
gas mixture containing 94.4% N2
and 5.6% CO2 + dithionite.
FO2Hb Measured according to the following ABL735
relation:
FO2Hb = 1 - (FHHb + FCOHb +
FMetHb)
FHHb 0%: whole blood is tonometered ABL735
with a gas mixture containing
94.4% N2 and 5.6% CO2 +
dithionite.
FCOHb Gas chromatography: The ABL735
Standards are carbon monoxide
mixtures with atmospheric air,
whose purity is validated in
accordance with NIST SRM 1678 (50
ppm CO in N2)
FMetHb Spectrometry, modified Evelyn- ABL735 [Ref. 7]
Malloy method.
ctBil The reference method for total ABL735
bilirubin is a spectrophotometric
method (wet chemistry based on a
method from Bayer Healthcare,
Tarrytown USA).
The method is traceable to NIST
SRM916a Bilirubin.
FHbF The reference method is based on ABL735 [Ref. 15]
Cation Exchange HPLC.
General reference: [Ref. 10].

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ABL90 FLEX reference manual 7. Performance characteristics

Coefficient of The coefficient of variation is reported as a percentage and calculated from the mean
variation (or measuring level) and standard deviation as follows:
(CV%)

Standard deviation
CV% =  100
Measuring level

Confidence Confidence interval provides a range of values estimated from a study group that is
intervals highly likely to include the true, but unknown, value ("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.

Repeatability/ Repeated measurements using one analyzer on samples assumed to be identical will
Reproducibility not necessarily yield identical results. The degree of variation in the results is a
measure of the precision of the analyzer.
The table on the next page describes the parameters used to characterize precision
obtained via the performance tests on the ABL90 FLEX analyzer. [Ref. 9]

Parameter Description
S0 Repeatability
This is a standard deviation obtained from repeated
measurements within a short interval of time using:
 The same instrument and location
 The same measurement procedure
 Identical portions of the same sample
 One operator per instrument
S0 for each level is pooled for all test instruments and test
days.
Sx Reproducibility is obtained from repeated measurements over
several days using:
 Random instrument
 Random sample
 Random operators
Reproducibility for each level is pooled for all test instruments
and test days.

Total analytical TEA, total analytical error is a quality specification that sets a limit for both the random
error error (imprecision) and systematic error (inaccuracy) in a single measurement or single
test result. In Radiometer reference manual the following expression for total analytical
error is either expressed in an absolute number
TEA = (|Bias|+1.96×Sx)
or in %
TEA = (|Bias%|+1.96×CVx) %
The formula we are using for total error allowable works at 95% probability to allow for
5% error.

7-5
7. Performance characteristics ABL90 FLEX reference manual

Test conditions
Test conditions to determine biasPrim.ref, biasSec.ref, repeatability, reproducibility and total
variation for pH, pCO2, pO2, cCa2+, cCl–, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb,
FCOHb, FMetHb, FHHb, ctBil and FHbF were as follows:

Item Description
Reference analyzers 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.
Primary/secondary As specified for each parameter earlier in this
reference methods chapter.
Analyzers and test 8-10 ABL90 FLEX analyzers were tested in syringe
modes and capillary mode.
Blood samples Heparinized blood samples from healthy, voluntary
donors.
The blood is prepared to obtain different
concentration levels of each measured parameter.
Blood measurements Measurements on every parameter are performed
on all analyzers, with 5 measurements on every
sample of each run, repeated for 3 days.
The measurements were performed by different
operators.
Solution pack All calibration solutions and gases used for the tests
are traceable to Primary Reference Standards.
Traceability certificates for the ABL90 FLEX
calibration solutions and gases are found at the end
of chapter 9: Solutions.
Experimental Ambient temperature: 22-25 °C
conditions
Relative humidity: 30-50 %.
Barometric pressure: 730 - 780 mmHg

NOTICES:  The solutions used in the performance tests are those

recommended by Radiometer. Performances using other
solutions cannot be guaranteed.
 The performance tests are performed under conditions where
the analyzers are not influenced by electromagnetic fields.

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ABL90 FLEX reference manual 7. Performance characteristics

Performance test results – chart description

General reference for the entire section: [Ref. 11].

Modes Tests were performed in the following modes:

Mode Volume
Syringe 65 µL
Capillary 65 µL

Number of The number of measurements during the test are listed below:
measurements

Parameter Number of Test period, Number of

measurements days Instruments
pH 786 30 8
pCO2 691 25 10
pO2 917 27 9
+
cK 800 13 10
+
cNa 799 30 8
cCa2+ 797 30 8
–
cCl 799 30 8
cGlu Blood: 1268 23 9
Serum pool: 408 23 9
cLac Blood: 1622 22 8
Serum pool: 546 22 8
ctHb 1042 8 10
sO2 1193 22 10
FO2Hb 1193 22 10
FCOHb 1041 12 10
FMetHb 1049 9 10
FHHb 1193 22 10
FHbF 864 24 10
ctBil 649 16 10

7-7
7. Performance characteristics ABL90 FLEX reference manual

Performance test results – pH

Reference Capillary-type glass pH electrode with a saturated calomel reference electrode and a
method liquid junction saturated with KCl (BMS Mk2) [Ref. 1,2].
The calibration standards are traceable to the Primary Reference Standards for pH.

BiasPrim.ref pH BiasPrim.ref N
7.0 0.008 45
7.4 -0.004 45
7.6 0.004 45
N = number of measurements employed

BiasABL90-Prim.ref = BiasABL90-ABL735 + BiasABL735-Prim.ref

BiasSec.ref and pH BiasSec.ref S0 SX TEA

Repeatability –
blood samples 6.800 -0.007 0.0014 0.0076 0.022
7.000 -0.004 0.0012 0.0064 0.017
7.200 -0.002 0.0014 0.0064 0.015
7.400 -0.002 0.0014 0.0073 0.016
7.800 -0.006 0.0017 0.0113 0.028

Performance test results – pCO2

Reference Tonometry [Ref. 3].

method
The gases used for tonometry are traceable to NIST-certified Standard Reference
Materials.

BiasPrim.ref and pCO2 BiasPrim.ref S0 SX CVX% TEA TEA

Repeatability – (mmHg) (%)
blood samples
15.0 0.13 0.16 0.70 4.7 1.50 10.0
40.0 0.18 0.25 0.55 1.4 1.26 3.2
60.0 -0.16 0.29 0.87 1.5 1.87 3.1
80.0 -0.36 0.23 1.45 1.8 3.20 4.0
100 -0.77 0.85 2.36 2.4 5.40 5.4

7-8
ABL90 FLEX reference manual 7. Performance characteristics

Performance test results – pO2

Reference Tonometry [Ref. 3].

method
The gases used for tonometry are traceable to NIST-certified Standard Reference
Materials.

BiasPrim.ref and pO2 BiasPrim.ref S0 SX CVX% TEA TEA

Repeatability – (mmHg) (%)
blood samples
30.0 0.0 0.21 0.60 2.0 1.18 3.9
75.0 0.7 0.31 0.84 1.1 2.35 3.1
125 0.7 0.37 1.19 1.0 3.03 2.4
250 -2.0 1.54 2.93 1.2 7.74 3.1
500 -6.1 2.47 5.95 1.2 17.76 3.6

Performance test results – cK+

Reference NIST-certified Standard Reference Material SRM 909b (human serum).

method

BiasPrim.ref cK+ (mmol/L) BiasPrim.ref N

5.973 0.065 45
3.983 0.067 45
1.987 0.108 45
N = number of measurements on several analyzers used for the test.

BiasABL90-Prim.ref = BiasABL90-ABL735 + BiasABL735-Prim.ref

BiasSec.ref and cK+ BiasSec.ref S0 SX CVX% TEA TEA

Repeatability – (mmol/L) (%)
blood samples
2.0 0.09 0.02 0.08 4.0 0.25 12.3
4.0 0.09 0.01 0.08 2.0 0.25 6.2
6.0 0.12 0.01 0.11 1.8 0.34 5.6
8.0 0.05 0.01 0.12 1.5 0.29 3.6
10.0 -0.01 0.02 0.12 1.2 0.25 2.5

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7. Performance characteristics ABL90 FLEX reference manual

Performance test results – cNa+

Reference NIST-certified Standard Reference Material SRM 909b (human serum) and Radiometer-
method specified standard serum material (specified using flame photometry).

BiasPrim.ref and cNa+ BiasPrim.ref*) S0 SX CVX% TEA TEA

Repeatability – (mmol/L) (%)
blood samples
120 0.0 0.1 0.9 0.8 1.76 1.5
130 0.3 0.2 1.1 0.8 2.46 1.9
140 0.5 0.1 1.1 0.8 2.66 1.9
160 0.6 0.3 1.2 0.8 2.95 1.8
180 0.9 0.1 1.6 0.9 4.04 2.2

*) ABL735 corr. to NIST through:

Na(ABL735, corr) = 1.055 * Na(ABL735, meas) – 6.8966 (mM)

Performance test results – cCl–

Reference NIST-certified Standard Reference Material SRM 909b (human serum).

method

BiasPrim.ref cCl– (mmol/L) BiasPrim.ref N

89.11 -0.8 45
119.45 3.45 45

N = number of measurements on several analyzers used for the test.

BiasABL90-Prim.ref = BiasABL90-ABL735 + BiasABL735-Prim.ref

BiasSec.ref
and
cCl– BiasSec.ref S0 SX CVX% TEA TEA
Repeatability
– blood (mmol/L) (%)
samples 80 0.8 0.1 0.9 1.1 2.56 3.2
100 0.8 0.1 1.1 1.1 2.96 3.0
120 1.1 0.1 1.5 1.3 4.04 3.4
140 0.8 0.1 1.6 1.1 3.94 2.8
150 0.7 0.1 1.7 1.1 4.03 2.7

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ABL90 FLEX reference manual 7. Performance characteristics

Performance test results – cCa2+

Reference The calcium transfer standards were used. These are traceable to NIST SRM915 and
method have an ionic strength of 160.0 mmol per kg of water and pH 7.40 at 37 °C, using 1
mmol/L (37 °C) HEPES buffer.
The standards were produced as indicated in [4].

BiasPrim.ref cCa2+ (mmol/L) BiasPrim.ref N

0.4903 0.063 45
1.2608 0.022 45
2.5111 -0.02 45

Bias ABL90 FLEX - Prim.ref = Bias ABL90 FLEX - ABL735 + Bias ABL735 – Prim.ref

BiasSec.ref and cCa2+ BiasSec.ref S0 SX CVX% TEA TEA

Repeatability – (mmol/L) (%)
blood samples
0.5 -0.031 0.002 0.015 3.0 0.060 12.0
0.75 -0.011 0.002 0.014 1.9 0.038 5.1
1.25 0.013 0.003 0.017 1.4 0.046 3.7
1.75 0.044 0.005 0.024 1.4 0.091 5.2
2.50 0.063 0.010 0.037 1.5 0.136 5.4

Performance test results – cGlu

Reference Spectrophotometry, using the hexokinase (HK) method recommended by NCCLS/CLSI

method [Ref. 5], measured on serum.

BiasPrim.ref and Blood, pO2>90 mmHg

Repeatability –
blood samples cGlu BiasPrim.ref S0 SX CVX% TEA TEA
(mmol/L) (%)
2.0 -0.09 0.02 0.09 4.5 0.27 13.3
6.0 -0.07 0.06 0.16 2.7 0.38 6.4
10.0 0.23 0.09 0.24 2.4 0.70 7.0
25.0 -0.87 0.18 0.83 3.3 2.5 10.0
40 -1.58 0.52 2.33 5.8 6.2 15.4

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7. Performance characteristics ABL90 FLEX reference manual

Blood, pO2<90 mmHg

cGlu BiasPrim.ref S0 SX CVX% TEA TEA

(mmol/L) (%)
2.0 -0.09 0.01 0.10 5.0 0.29 14.3
6.0 -0.12 0.05 0.18 3.0 0.47 7.9
10.0 0.08 0.06 0.27 2.7 0.61 6.1
25.0 -1.73 0.28 0.84 3.4 3.4 13.5
40 -3.28 0.62 1.92 4.8 7.0 17.6

Serum pool, pO2>90 mmHg

cGlu BiasPrim.ref S0 SX CVX% TEA TEA

(mmol/L) (%)
2.0 -0.09 0.01 0.07 3.5 0.23 11.4
6.0 -0.07 0.03 0.13 2.2 0.32 5.4
10.0 0.23 0.04 0.24 2.4 0.70 7.0
25.0 -0.87 0.17 0.72 2.9 2.3 9.1
40 -1.58 0.45 1.36 3.4 4.3 10.6

Performance test results – cLac

Reference Spectrophotometry using a lactate dehydrogenase (LDH) method, measured on serum

method [Ref 10].

BiasPrim.ref and Blood, pO2>90 mmHg

Repeatability –
blood samples cLac BiasPrim.ref S0 SX CVX% TEA TEA
(mmol/L) (%)
0.3 0.03 0.01 0.08 26.7 0.19 62.3
1.0 0.03 0.05 0.12 12.0 0.27 27.0
5.0 0.09 0.07 0.22 4.4 0.52 10.4
10.0 0.19 0.10 0.77 7.7 1.70 17.0
15.0 0.29 0.11 0.92 6.1 2.09 13.9
25 0.06 0.24 2.32 9.3 4.61 18.4

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ABL90 FLEX reference manual 7. Performance characteristics

Blood, pO2<90 mmHg

cLac BiasPrim.ref S0 SX CVX% TEA TEA

(mmol/L) (%)
0.3 0.03 0.01 0.08 26.7 0.19 62.3
1.0 0.03 0.03 0.09 9.0 0.21 21.0
5.0 0.09 0.10 0.33 6.6 0.74 14.8
10.0 -0.05 0.08 0.78 7.8 1.58 15.8
15.0 -0.01 0.10 1.17 7.8 2.30 15.3
25 -1.26 0.21 2.70 10.8 6.55 26.2

Serum pool, pO2>90 mmHg

cLac BiasPrim.ref S0 SX CVX% TEA TEA

(mmol/L) (%)
0.3 0.03 0.01 0.07 23.3 0.17 56.7
1.0 0.03 0.01 0.07 7.0 0.17 17.0
5.0 0.09 0.04 0.17 3.4 0.42 8.4
10.0 0.19 0.04 0.45 4.5 1.07 10.7
15.0 0.29 0.06 0.78 5.2 1.82 12.1
25 0.06 0.16 1.92 7.7 3.82 15.3

Performance test results – ctHb

Reference HiCN method recommended by NCCLS [Ref. 6].

method

Setup:
Adult samples. HbF correction is not activated.

BiasPrim.ref and ctHb sO2 BiasPrim.ref*) S0 SX CVX% TEA TEA

Repeatability – (g/dL) (%) (%)
blood samples
0.00 - -0.02 0.01 0.02 - 0.06 -
3.5 100 0.02 0.04 0.08 2.3 0.18 5.1
7.0 100 0.05 0.08 0.16 2.3 0.36 5.1
10.0 100 0.06 0.07 0.20 2.0 0.45 4.5
15.0 100 0.06 0.07 0.24 1.6 0.53 3.5
20.0 100 0.00 0.09 0.29 1.5 0.57 2.9
25.0 100 0.08 0.11 0.37 1.5 0.81 3.2
*) ABL735 HICN-corr. through:
ctHb(ABL735),corr = -0.000707 * (ctHb(ABL735),meas)2
+ 0.9977 * ctHb(ABL735),meas

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7. Performance characteristics ABL90 FLEX reference manual

Performance test results – sO2

Reference Tonometry:
method
100%: whole blood is tonometered with a gas mixture containing 94.4% O2 and 5.6%
CO2.
0%: whole blood is tonometered with a gas mixture containing 94.4% N2 and 5.6% CO2
+ dithionite.

BiasPrim.ref ctHb sO2 BiasPrim.ref N

(g/dL) (%)
15 0 0.07 150
15 100 -0.26 150
7 100 0.46 150
25 100 0 148

N = number of measurements on several analyzers used for the test.

Setup:
Adult samples. HbF correction not activated.

BiasABL90-Prim.ref = BiasABL90-ABL735 + BiasABL735-Prim.ref

BiasSec.ref and ctHb sO2 BiasSec.ref S0 SX CVX% TEA TEA

Repeatability – (g/dL) (%) (%)
blood samples
15 0 0.09 0.07 0.25 - 0.58 -
15 50 -0.26 0.24 0.40 0.8 1.04 2.1
15 65 -0.20 0.27 0.46 0.7 1.10 1.7
15 75 -0.10 0.30 0.48 0.6 1.04 1.4
15 90 -0.10 0.19 0.35 0.4 0.79 0.9
15 100 -0.07 0.09 0.29 0.3 0.64 0.6
7 100 0.45 0.11 0.37 0.4 1.18 1.2
25 100 -0.53 0.09 0.28 0.3 1.08 1.1

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ABL90 FLEX reference manual 7. Performance characteristics

Performance test results – FO2Hb

Reference Measured according to the following relation:

method
FO2Hb = 1 - (FHHb + FCOHb + FMetHb)

Setup:
Adult samples. HbF correction is not activated.

BiasSec.ref and FO2Hb ctHb BiasSec.ref S0 Sx CVX% TEA TEA

Repeatability – (%) (g/dL) (%)
blood samples
0.0 15 0.07 0.07 0.25 - 0.56 -
50.0 15 -0.25 0.27 0.58 1.2 1.39 2.8
65.0 15 -0.43 0.30 0.48 0.7 1.37 2.1
75.0 15 -0.27 0.35 0.55 0.7 1.35 1.8
90.0 15 -0.23 0.23 0.40 0.4 1.01 1.1
100.0 15 -0.10 0.16 0.38 0.4 0.84 0.8
100.0 7 -0.09 0.19 0.48 0.5 1.03 1.0
100.0 25 -0.45 0.18 0.53 0.5 1.49 1.5

Performance test results – FCOHb

Reference Gas chromatography: The Standards are carbon monoxide mixtures with atmospheric
method air, whose purity is validated in accordance with NIST SRM 1678 (50 ppm CO in N2).

Setup:
Adult samples. HbF correction is not activated.

BiasPrim.ref ctHb FCOHb (%) BiasPrim.ref N

(g/dL)
15 0 0.22 45
15 20 -1.01 45

N = number of measurements on several analyzers used for the test.

BiasABL90-Prim.ref = BiasABL90-ABL735 + BiasABL735-Prim.ref

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7. Performance characteristics ABL90 FLEX reference manual

BiasSec.ref and ctHb FCOHb BiasSec.ref S0 SX CVX% TEA TEA

Repeatability – (g/dL) (%) (%)
blood samples
15 0.0 0.00 0.07 0.23 - 0.45 -
15 5.0 0.08 0.07 0.26 5.2 0.59 11.8
15 10.0 0.04 0.06 0.34 3.4 0.71 7.1
15 20.0 0.11 0.07 0.67 3.4 1.42 7.1
15 30.0 0.17 0.07 0.68 2.3 1.50 5.0
15 50.0 0.30 0.08 0.68 1.4 1.63 3.3
15 99.0 0.54 0.12 0.72 0.7 1.95 2.0

Performance test results – FMetHb

Reference Spectrometry, modified Evelyn-Malloy method [Ref. 7].

method

Setup:
Adult samples. HbF correction is not activated.

BiasPrim.ref ctHb FMetHb (%) BiasPrim.ref N

(g/dL)
15 0 0.12 45
15 20 -0.76 45

N = number of measurements on several analyzers used for the test.

BiasABL90-Prim.ref = BiasABL90-ABL735 + BiasABL735-Prim.ref

BiasSec.ref and
Repeatability –
blood samples ctHb FMetH BiasSec.ref S0 SX CVX% TEA TEA
(g/dL) b (%) (%)
15 0.0 -0.04 0.10 0.23 - 0.49 -
15 5.0 0.02 0.09 0.25 5.0 0.51 10.2
15 10.0 -0.04 0.12 0.33 3.3 0.69 6.9
15 20.0 -0.18 0.08 0.27 1.4 0.71 3.5
15 30.0 -0.26 0.08 0.34 1.1 0.93 3.1
15 50.0 -0.21 0.09 0.43 0.9 1.05 2.1
15 99.0 0.11 0.05 0.61 0.6 1.31 1.3

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ABL90 FLEX reference manual 7. Performance characteristics

Performance test results – FHHb

Reference 0%: whole blood is tonometered with a gas mixture containing 94.4% N2 and 5.6% CO2
method + dithionite.

Setup:
Adult samples. HbF correction is not activated.

BiasSec.ref and FHHb ctHb BiasSec.ref S0 Sx CVX% TEA TEA

Repeatability – (%) (g/dL) (%)
blood samples
0.0 15 0.07 0.10 0.28 - 0.62 -
10.0 15 0.08 0.18 0.35 3.5 0.77 7.7
25.0 15 0.05 0.30 0.48 1.9 0.99 4.0
35.0 15 0.08 0.27 0.50 1.4 1.06 3.0
50.0 15 0.11 0.26 0.57 1.1 1.23 2.5
100.0 15 -0.14 0.16 0.40 0.4 0.92 0.9
0.0 7 -0.45 0.13 0.36 - 1.16 -
0.0 25 0.53 0.09 0.26 - 1.04 -

Performance test results – FHbF

Reference The reference method is based on Cation Exchange HPLC. The method is described in
method [Ref. 15]. The method is performed by the Hæmatology Laboratory at Herlev Hospital,
Denmark.

Setup:
Mixed adult and Fetal samples. HbF correction enabled for all levels.

BiasPrim.ref and FHbF ctHb BiasPrim.ref*) S0 SX CVX% TEA TEA

Repeatability – (%) (g/dL) (%)
blood samples
0 15 1.6 1.8 3.0 - 7.48 -
5 15 3.2 1.8 3.3 66 9.67 193
10 15 0.9 1.7 3.2 32 7.17 71.7
20 15 1.1 1.8 3.6 18 8.16 40.8
30 15 -1.7 1.8 4.2 14 9.93 33.1
50 15 -3.1 1.6 3.9 7.8 10.74 21.5
80 15 -4.2 1.8 4.1 5.1 12.24 15.3
*) ABL735 corrected to HPLC through:
FHbF(ABL735),corr = FHbF (ABL735),meas – 0.9* ctHb + 11.7

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 7. Performance characteristics ABL90 FLEX reference manual

Performance test results – bilirubin

Reference The reference method for total bilirubin is a spectrofotometric method (wet chemistry
method based on a method from Bayer Healthcare, Tarrytown USA.
The method is calibrated using NIST SRM916a Bilirubin.
The method is performed by the Laboratory Unilabs AS., Denmark.

Setup:
HbF correction is not activated

BiasPrim.ref ctBil ctHb (g/dL) BiasPrim.ref N

(µmol/L)
0 15 0.8 3
200 15 4.7 3
400 15 4.7 3

BiasABL90-Prim.ref = BiasABL90-ABL735 + BiasABL735-Prim.ref

BiasSec.ref ctBil ctHb BiasSec.ref S0 SX CVX% TEA TEA

(µmol/L) (g/dL) (%)
8 15 1.0 2.7 7.1 89 14.9 186
100 15 0.2 3.2 9.7 9.7 19.2 19.2
200 15 -4.8 3.6 12.7 6.4 29.7 14.9
400 15 -5.3 4.8 13.9 3.5 32.5 8.1
600 15 -11.7 5.9 18.0 3.0 47.0 7.8

NOTES:
a. Adult/fetal blood, pH = 7.4  0.1, normal MCHC and albumin variation. Spiked
with unconjugated bilirubin.

External test The purpose of the bilirubin external tests was to make a regression study of ABL90
results bilirubin against reference hospital analyzers on hospital neonatal blood samples.
A limited study was performed on hospital adult samples [Ref. 13].

For neonatal use: The bilirubin method has been evaluated on whole blood.
The allowed analytical error is 10% to satisfy average
clinical requirements for bilirubin measurement
[16,17,18,19,20]. For whole blood the analytical error is
slightly higher.

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ABL90 FLEX reference manual 7. Performance characteristics

For adult use: Adult samples within reference range:

The uncertainty in the bilirubin measurement on whole
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
whole-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
analyzer – a total of three.

Wet Chemistry analyzer Roche Modular with Roche Calibrator was used as a reference
[Ref. 21]. Each external test site had two Modulars – a total of four. ctBil was measured
in mol/L.

The field test results are given below:

400
y = 1.014x - 0.828
R2 = 0.985
350

300
N=175

250
Syx=11.6
ABL90

200

150

100

50

0
0 100 200 300 400
Modular

Syx is the spreading around the linear line.

Actual external test from neonatal critical care hospitals using whole blood. Data from
three field tests are merged. Values are in µmol/L.

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7. Performance characteristics ABL90 FLEX reference manual

The same data as above but depicted in a Bland-Altman plot below.

50

40

30

20

10
Difference

0
0 100 200 300 400
-10

-20

-30

-40

-50
ctBil

Lines indicate “Mean” and +/- “15 umol or 10%”. Values are in µmol/L. Difference =
ABL90 – Modular.

Interference tests

The results from the interference tests are given as the deviation from the correct result
[Ref. 14].

pH/blood gas The following interference results are found for the pH and blood gas electrodes:

Interference on ...
Test pH pCO2 pO2
Substance Test matrix
Concentration mmHg
(level 7.4)

Intralipid 2% <0.010 N/A <1 Blood/Aqueous

5% <0.010 N/A <1 Blood/Aqueous

Fluorescein 400 mg/L N/A N/A <1 Blood

+
K 17 mM <0.010 N/A N/A Blood
+
Na 190 mM <0.010 N/A N/A Blood
2+
Ca 5.5 mM <0.010 N/A N/A Blood

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ABL90 FLEX reference manual 7. Performance characteristics

Electrolytes The following interference results are found for the electrolyte electrodes:

Interference on …....
+
cK cNa+ cCa2+ cCl-
(4 mM
Test con- (140 mM (1.25 mM (105 mM Test
level)
Substance centration level) level) level) matrix
Lithium (Li+) 3.2 mM <0.1 <1 <0.02 N/A Plasma
+
Potassium (K ) 12 mM N/A <1 <0.02 N/A Plasma
2+
Calcium (Ca ) 3.4 mM <0.1 1.2 N/A N/A Plasma

2.2 mM N/A <1 N/A N/A Plasma

1.8 mM N/A <1 N/A N/A Plasma

1.6 mM N/A <1 N/A N/A Plasma

+
Sodium (Na ) 180 mM N/A N/A 0.029 N/A Plasma
+
Ammonium(NH4 ) 1 mM <0.1 <1 N/A 1.1 Plasma

107 M <0.1 <1 N/A <1 Plasma

2+
Magnesium (Mg ) 5 mM N/A <1 <0.02 N/A Aqueous
2+
Zinc (Zn ) 170 M <0.1 <1 0.024 N/A Plasma
2+
Strontium (Sr ) 150 M N/A N/A <0.02 N/A Plasma

pH Aqueous/
-0.037
N/A N/A mM/pH N/A buffer
6.8 – 8 N/A N/A N/A <1 Plasma
-
Bromide (Br ) 37.5 mM N/A N/A N/A 76.6 Plasma

18.75 mM N/A N/A N/A 37.6 Plasma

10 mM N/A N/A N/A 19.5 Plasma

5 mM N/A N/A N/A 10.1 Plasma

1 mM N/A N/A N/A 1.8 Plasma

-
Iodide (I ) 2.99 mM N/A N/A N/A 12.4 Plasma

1.5 mM N/A N/A N/A 5.3 Plasma

1 mM N/A N/A N/A 3.5 Plasma

0.75 mM N/A N/A N/A 2.5 Plasma

-
Fluoride (F ) 107 M N/A N/A N/A <1 Plasma

1 mM N/A N/A N/A <1 Plasma

Perchlorate 1.5 mM 0.3 - 0.27* 4-30 Plasma

-
(ClO4 )

Benzalkonium chloride 7.5 g/mL 0.27 8.7 0.138 <1 Plasma

10 g/mL 0.39 12.1 0.182 <1 Plasma

15 g/mL 0.60 18.8 0.269 <1 Plasma

30 g/mL 1.28 40.4 0.622 <1 Plasma

* Depending on the pH level

A "-" indicates that interference has not been measured on the respective parameter.

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7. Performance characteristics ABL90 FLEX reference manual

Interference on …....
+
cK cNa+ cCa2+ cCl-
(4 mM
Test con- (140 mM (1.25 mM (105 mM Test
level)
Substance centration level) level) level) matrix
Acetylsalicylic acid 0.91 mM N/A N/A N/A <1 Plasma

1.21 mM N/A N/A N/A <1 Plasma

1.81 mM N/A N/A N/A 1.1 Plasma

3.62 mM N/A N/A N/A 3.0 Plasma

Salicylic acid 1.09 mM N/A N/A N/A <1 Plasma

1.45 mM N/A N/A N/A <1 Plasma

2.17 mM N/A N/A N/A 1.7 Plasma

4.34 mM N/A N/A N/A 5.2 Plasma

Thiocyanic acid 0.43 mM N/A N/A N/A 4.8 Plasma

0.57 mM N/A N/A N/A 5.5 Plasma

0.86 mM N/A N/A N/A 8.7 Plasma

1.72 mM N/A N/A N/A 17.2 Plasma

Ascorbic acid 170 M N/A N/A N/A <1 Plasma

850 M N/A N/A N/A <1 Plasma

Citrate 1 mM N/A N/A N/A <1 Plasma

40 mM N/A N/A N/A -4.9 Plasma

Oxalate 1 mM N/A N/A N/A <1 Plasma

10 mM N/A N/A N/A <1 Plasma

Lactate 25 mM N/A N/A N/A <1 Plasma

Caprylic acid 0.12 mM N/A N/A N/A <1 Plasma

Acetyl-tryptophane 0.12 mM N/A N/A N/A <1 Plasma

Number in bold: Exceeds specifications

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ABL90 FLEX reference manual 7. Performance characteristics

Metabolites The following interference results are found for the metabolite electrodes:

Interference on
.......
Test Test
Substance Concentration Glu mM Lac mM matrix
Acetaminophen=paracetamol 2 mM < 0.1 < 0.1 Whole blood

Acetylsalicylic acid 3.62 mM < 0.1 < 0.1 Whole blood

Ibuprofen (sodium) 2.5 mM < 0.1 < 0.1 Whole blood

Dopamine HCl 1 mM < 0.1 < 0.1 Whole blood

Chlorpromazine HCl 0.2 mM < 0.1 < 0.1 Whole blood

Ethanol 87 mM < 0.1 < 0.1 Whole blood

Glucosamine HCl 2 mM 0.12 < 0.1 Whole blood

0.25 mM N/A 0.31 Whole blood

0.33 mM N/A 0.39 Whole blood

Glycolic acid
0.5 mM N/A 0.48 Whole blood

1 mM < 0.1 0.52 Whole blood

Lactic acid 12 mM < 0.1 N/A Whole blood

Maltose (monohydrate) 5 mM < 0.1 < 0.1 Whole blood

Mannose 1 mM 0.11 < 0.1 Whole blood

Salicylic acid 4.34 mM < 0.1 < 0.1 Whole blood

6 mM 14.39 10.95 Whole blood

8 mM 19.31 14.57 Whole blood

Sodium thiocyanate
12 mM 31.08 21.91 Whole blood

24 mM 94.69 58.75 Whole blood

Xylose 1 mM < 0.1 < 0.1 Whole blood

Acetoacetate (Lithium
acetacetoacetate) 2 mM < 0.1 0.11 Whole blood

Creatinine 3 mM < 0.1 < 0.1 Whole blood

Galactose 3.3 mM 0.14 < 0.1 Whole blood

D-Glucose 67 mM N/A -0.21 Whole blood

Pyruvate (pyruvic acid sodium

salt) 2 mM < 0.1 < 0.1 Whole blood

Urea 84 mM < 0.1 < 0.1 Whole blood

Uric acid 1.5 mM < 0.1 < 0.1 Whole blood

Heparin 8000 iu/dL < 0.1 < 0.1 Whole blood

EDTA (Edetate disodium

2H2O) 3 mM < 0.1 < 0.1 Whole blood

Citrate (sodium citrate 2H2O) 1 mM < 0.1 < 0.1 Whole blood

Oxalate (sodium oxalate) 1 mM < 0.1 < 0.1 Whole blood

Fluoride (Sodium fluoride) 50 mM -0.12 -0.13 Whole blood

Pralidoxime chloride 0.045 mM < 0.1 < 0.1 Whole blood

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7. Performance characteristics ABL90 FLEX reference manual

Interference on
.......
Test Test
Substance Concentration Glu mM Lac mM matrix
2-deoxy Glucose 2.5 mM 2.25 N/A Whole blood

3.33 mM 2.88 N/A Whole blood

5 mM 4.58 N/A Whole blood

10 mM 9.58 < 0.1 Whole blood

Unconjugated Bilirubin 0.2 g/L < 0.1 < 0.1 Whole blood

Conjugated Bilirubin 0.2 g/L < 0.1 < 0.1 Whole blood

Ascorbic acid 170 µmol/L < 0.1 < 0.1 Whole blood

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 ABL90 FLEX reference manual 7. Performance characteristics

Oximetry The substances against which the oximetry parameters (ctHb, sO2, FO2Hb, FCOHb,
parameters FMetHb, FHHb, FHbF) and ctBil were tested for interference are given in the table
below:
(SAT100 blood reference test sample: ctHb = 15 g/dL, sO2 = 100 %, FCOHb = 0.7%,
FMetHb = 0.5%, ctBil = 0, pH = 7.4. Parameter sensitivity from the influence on the
absorbance spectrum from various substances.)

ctHb sO2 FO2Hb FCOHb FMetHb FHHb FHbF ctBil

g/dL % % % % % % µmol/L
Limit for clinical relevance…..
Level
30
0.5 g/dL 1% 1% 1% 1% 1% 20% µmol/L

6.85 <|0.5| <|1%| -1.1 <|1%| <|1%| <|1%| ND <|30|

pH
7.15 <|0.5| <|1%| <|1%| <|1%| <|1%| <|1%| ND <|30|

7.4 Reference pH

8 <|0.5| <|1%| <|1%| <|1%| <|1%| <|1%| 22 <|30|

Fluorescein 250 mg/L 1.34 -3.2 -9.6 -4.1 10.7 2.9 ND -1115

beta-carotene*) 3.7 µmol/L <|0.5| <|1%| <|1%| <|1%| <|1%| <|1%| <|20%| <|30|

Patent Blue V 10 mg/L <|0.5| <|1%| 2.2 <|1%| <|1%| <|1%| ND <|30|

10 mg/L -0.66 <|1%| 5.3 <|1%| -4.5 <|1%| ND -57

Methylene Blue
30 mg/L -2.14 3.0 19.5 <|1%| -16.0 -3.3 ND -161

60 mg/L -3.99 4.8 40.5 -2.7 -31.5 -6.3 ND -282

Cardio Green 7 mg/L <|0.5| <|1%| <|1%| <|1%| <|1%| <|1%| <|20%| <|30|

30 mg/L <|0.5| <|1%| 2.2 <|1%| -1.7 <|1%| ND <|30|

Evans Blue 5 mg/L <|0.5| <|1%| <|1%| <|1%| <|1%| <|1%| <|20%| <|30|

2% (200
mg/dL) <|0.5| <|1%| <|1%| <|1%| <|1%| <|1%| <|20%| <|30|
Intralipid 5% (1000
mg/dL) <|0.5| <|1%| <|1%| <|1%| <|1%| <|1%| <|20%| <|30|

HiCN 30% 1.90 -14.1 -40.6 6.7 24.1 9.8 ND 895

SHb 20% -2.17 <|1%| <|1%| <|1%| <|1%| <|1%| ND <|30|

50% -4.69 1.8 -4.6 <|1%| 6.4 -1.7 ND 119

Bilirubin (unconj) 500 µmol/L <|0.5| <|1%| <|1%| <|1%| <|1%| <|1%| <|20%| 524

Bilirubin (conj) 400 µmol/L <|0.5| <|1%| <|1%| <|1%| <|1%| <|1%| <|20%| 377

Hydroxocoba- 2 g/L 2.43 <|1%| -16.0 2.6 12.7 <|1%| ND -87

lamin
0.8 g/L 1.10 <|1%| -7.3 1.1 5.9 <|1%| <|20%| -37

0.4 g/L 0.53 <|1%| -4.0 <|1%| 3.4 <|1%| <|20%| <|30|

0.2 g/L <|0.5| <|1%| -2.4 <|1%| 1.8 <|1%| <|20%| <|30|

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7. Performance characteristics ABL90 FLEX reference manual

ctHb sO2 FO2Hb FCOHb FMetHb FHHb FHbF ctBil

g/dL % % % % % % µmol/L
Limit for clinical relevance…..
Level
30
0.5 g/dL 1% 1% 1% 1% 1% 20% µmol/L

2 g/L 2.35 -4.1 -16.4 2.9 9.9 3.5 ND <|30|

Cyanocobalamin
0.8 g/L 1.19 -2.1 -8.8 1.6 5.3 1.9 <|20%| <|30|

0.4 g/L 0.71 -1.2 -5.2 <|1%| 3.2 1.2 <|20%| <|30|

0.2 g/L <|0.5| <|1%| -2.2 <|1%| 1.4 <|1%| <|20%| <|30|

* Interference calculated from spectrum

ND: Not displayed
Numbers/text in bold: Exceeds limits for clinical relevance

FHbF FHbF is sensitive to pH deviations from the nominal value of pH = 7.4. If pH is

sensitivity for converted into cH+ (hydrogen ion concentration), the relationship between the changes
pH changes in cH+ and FHbF is linear as seen from the following equation:

∆FHbF =
− 0.51% /(nmol/L) × (cH + − 40 nmol/L)

pH ∆FHbF %
7.15 -15.8
7.25 -8.2
7.4 0
7.5 4.1
7.6 7.7

ctBil sensitivity MCHC (Mean Corpuscular Hemoglobin Concentration) is used to estimate hematocrit,
for MCHC Hct, which is used in the ctBil measurement. MCHC is an average Hb concentration in
variations 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:
ctHb
Hct =
MCHC

A standard value of 332 g/L is assumed for MCHC which gives

Hct = ctHb × 0.0301 if the unit for ctHb is g/dL.
MCHC can, however, deviate from this standard value as illustrated in the following
table (see the next page).
Erythrocytometric values given for “apparently healthy” white and black subjects of
different ages are taken from: “Geigy Scientific Tables, Physical Chemistry, Composition
of Blood, Hematology, Somametric Data”, CIBA-GEIGY, 1984; 3, 207.

7-26
ABL90 FLEX reference manual 7. Performance characteristics

Subjects Age Hct Hct MCHC MCHC 95

mean 95 % range mean, g/L % range,
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 MCHC is defined as MCHC = 332 g/L  MCHC, then the contribution to the relative
error on the ctBil measurement is as follows:
ctBil Hct MCHC
 
ctBil 1  Hct MCHC

A worst-case example, using 95 % confidence values:

A newborn girl with Hct = 0.58, MCHC = 350 g/L and ctBil = 400 mol/L. ctHb may be
derived as Hct  MCHC = 0.58 x 350 g/L = 20.3 g/dL (reference range is 18.0  21.0
g/dL).
ctBil 0.58 18
   0.071 And ctBil = 0.071 x 400 = 28 mol/L.
ctBil 1  0.58 350

If the reference value for Hct is known, it is possible to correct the displayed ctBil value,
using the following equation:
1  ctHb(displayed)  0.0301
ctBil(corrected)  ctBil(displayed) 
1  Hct(reference)

ctHb is measured in g/dL.

7-27
7. Performance characteristics ABL90 FLEX reference manual

ctBil is slightly sensitive to pH deviations from the nominal value of pH = 7.4.

General reference: [Ref. 12]

Anticoagulants Anticoagulants containing sodium salts give erroneously high cNa+ results. Sodium
(sampling) fluoride with or without EDTA and oxalate (disodium) affects cGlu results. Sodium
fluoride gives erroneously high cNa+ and low cCa2+, cGlu and cLac results. Trisodium
citrate affects cNa+, cK+ and cGlu results.
Radiometer, therefore, recommends the use of heparin as the only anticoagulant.

WARNING - Risk of erroneous results

Do not use EDTA, as it leads to erroneous pH, pCO2, cNa+, cK+ and cCa2+
results. Use of EDTA will also affect subsequent measurements on the Ca
electrode and it will reduce the lifetime of this electrode.

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ABL90 FLEX reference manual 7. Performance characteristics

List of
references 1. Kristensen HB, Salomon A, Kokholm G. International pH scales and certification of pH.
2. Definition of pH scales, standard reference values, measurement of pH and related
terminology (Recommendations 1994). Pure and Appl Chem 1985; 57, 3: 531-42.
3. Burnett RW, Covington AK, Maas AHJ, Müller-Plathe O et al. J Clin Chem Clin Biochem 1989;
27: 403-08.
4. IFCC reference methods and materials for measurement pH, gases and electrolytes in blood.
Scand J Clin Lab Invest 1993; 53, Suppl 214: 84-94.
5. Glucose. CLSI/NCCLS Publication RS1-A. Clinical and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, PA 19087, 1989.

6. Reference and selected procedures for the quantitative determination of hemoglobin 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.
7. Evelyn K, Malloy H. Microdetermination of oxyhemoglobin, methemoglobin and sulfhemoglobin
in a single sample of blood. Biological Chem 1938; 126: 655-62.
8. Begmeyer. Methods of enzymatic analysis. 3rd ed., Verlag Chemie Deerfield Beach 1984; 6:
582-88.
9. VIM93: ISO, International Vocabulary of Basic and General Terms in Metrology, Geneva:
International Organization for Standardization; 1993.
10. Kristensen H.B. Traceability to the primary reference standards at Radiometer. Copenhagen:
Radiometer Medical ApS, 2004. Code 918-541.
11. CLSI Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guidelines,
EP5-A, Vol. 19, No. 2.
12. CLSI Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved
Guidelines, EP17-A, Vol. 24, No. 34.
13. CLSI Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline –
Second Edition, EP9-A2, Vol. 22, No. 17.
14. CLSI approved guideline for interference testing in clinical chemistry, EP7-A, Vol. 22, No. 27.
15. Tan GB, Aw TC, Dunstan RA & Lee SH, Evaluation of high performance liquid chromatography
for routine estimation of haemoglobins A2 and F. Journal of Clinical Pathology 46: 852-856.”
16. Fraser CG. The application of theoretical goals based on biological variation data in proficiency
testing. Arch Pathol Lab Med 1988; 112: 402-15.
17. 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.
18. 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.
19. 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.
20. Vanderline RE, Goodwine J, Koch D, Scheer D, Steindel S, Cembrowski G. Guidelines for
providing quality stat laboratory services. 1987 Laboratory Quality Assurance Commitee.
21. 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.

7-29
7. Performance characteristics ABL90 FLEX reference manual

7-30
 8. Parameters

General information........................................................................... 8-2

Measured parameters ........................................................................ 8-6
Input parameters .............................................................................8-13
Derived parameters..........................................................................8-15
Units and numerical format of derived parameters ................................8-19
List of equations ..............................................................................8-23
Oxyhemoglobin dissociation curve (ODC).............................................8-37
Conversion of units ..........................................................................8-42
Default values .................................................................................8-44
References ......................................................................................8-45
8. Parameters ABL90 FLEX reference manual

General information
The Deep The Deep Picture developed by Radiometer [1] (visit our website www.deep-
Picture picture.com) expands traditional pH and blood gas analysis by evaluating the
capability of arterial blood to carry sufficient oxygen to tissues and to release it.
It simplifies interpretation by dividing the process into three stages:

Stage Description
Oxygen Oxygen uptake in the lungs indicates whether the pulmonary gas
uptake exchange is efficient enough to oxygenate arterial blood.
The uptake of oxygen in the lungs can be described by
parameters in combination, primarily the arterial oxygen tension
(pO2(a)), fraction of O2 in dry inspired air (FO2(I)) and shunt
· ·
fraction of perfused blood (Qs /Q t)
However, other parameters may also be used, such as the
difference in alveolar air and arterial blood oxygen tension
(pO2(A-a)).
Oxygen Oxygen transport reveals if arterial blood contains sufficient
transport oxygen.
The oxygen concentration of arterial blood (ctO2(a)) also termed
oxygen content is determined by the concentration of total
hemoglobin (ctHb(a)), the fraction of oxygenated hemoglobin
(FO2Hb(a)) and the arterial oxygen tension (pO2(a)).
Other parameters that should be known are the oxygen
saturation (sO2 (a)) and the fractions of dyshemoglobins
(FCOHb(a) and FMetHb(a)).
Oxygen Oxygen release describes the ability of arterial blood to release
release oxygen to the tissues.
The release of oxygen from capillaries to tissues is determined by
the oxygen tension gradient between the two. This release of
oxygen is also influenced by the hemoglobin-oxygen affinity,
which is indicated by the oxygen tension at 50 % saturation,
p50.

8-2
ABL90 FLEX reference manual 8. Parameters

Symbols The symbols for the parameters are based on the principles described by
Wandrup [2]. Each symbol consists of three parts, described below:

1. Property A symbol in italics p for pressure

describing the quantity c for concentration
F for fraction
V for volume
etc.
2. Component An abbreviation of the O2 for oxygen
component name CO2 for carbon dioxide
COHb for carboxyhemoglobin
etc.
3. (System) Specification of the system B for blood
P for plasma
a for arterial blood
–
v for mixed venous blood
A for alveolar air
T for patient temperature

component
Example:

pO2(a)

property system

The parameters are listed by symbol in three groups: measured, input and
derived.

8-3
8. Parameters ABL90 FLEX reference manual

Ranges and The following ranges are used:

limits
Range Description
Indication The range of indication for a parameter is the range within which
the analyzer is physically capable of measuring.

Reportable Is user-defined; is equal to or narrower than the range of

indication. Can be selected for all measured and derived
parameters.
Reportable range is the range of results from a testing system or
method over which a specified analytical performance is claimed.
Reference "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" [10].
Ref. 10 has been the source for the reference ranges given in this
section. In some cases the values are taken from other sources
marked by their reference number.
When possible, the reference ranges for arterial blood have been
listed. Reference ranges must be used with caution as they
depend on a number of factors, such as sex, age and normal
physiological condition.

Critical limits are user-defined and can be entered into the analyzer software –
see section Reference ranges and critical limits in chapter 1.

Derived Derived parameters are calculated according to the equations stated.

parameters
If… Then…
the required measured or default values are used, unless a measured
input values are unknown parameter does not have a value or is
outside the range of indication.
all values are known the derived parameter is designated
calculated and a "c" is added to the result.
a default value is used the derived parameter is designated
estimated and an "e" is added to the result.

If one or more default values have been used in the calculation, the result may
deviate significantly from the true value. The deviation on "estimated" oxygen
status parameters might become particularly significant if default values are
used instead of measured blood oximetry data.
In some cases, however, the default value is not accepted as the input for the
calculation. This is because the actual values of the missing parameter may
deviate significantly from the default value, thus making the estimation clinically
inappropriate. If sO2 cannot be measured due to severe errors, it will be
calculated.

8-4
ABL90 FLEX reference manual 8. Parameters

Measured Some of the listed parameters are measured, depending on the analyzer
parameters configuration. In these cases the equation given only applies if that parameter is
not directly measured by the analyzer.

Sample type Unless otherwise stated, a parameter will be calculated or estimated irrespective
of the choice on the Patient Identification screen: "Arterial", "Capillary",
"Venous", "Mixed venous" or "Not specified". Some parameters, however, are
defined for arterial 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 The units given for each parameter refer to the units available on the analyzer for
that parameter.

Default values The default values are listed in Default values at the end of this chapter.

8-5
8. Parameters ABL90 FLEX reference manual

Measured parameters
General The following is the used:
information
m= male
f= female
Reference For adult arterial blood
range
Reference [10]
(unless otherwise specified)

pH Definition Indicates the acidity or alkalinity of the sample.

Unit -
Range of indication 6.300-8.000
Reference range 7.35-7.45 (m, f)

cH+ Definition Concentration of hydrogen ions in blood.

Unit nmol/L
Range of indication 10.0-501
Reference range 35.5-44.7 (m, f)

pCO2 Is used both for blood and expired-air samples.

Definition Partial pressure (or tension) of carbon dioxide in
blood.
High and low pCO2 values of arterial blood
indicate blood hypercapnia and hypocapnia,
respectively.
Unit mmHg; kPa; Torr
Range of indication mmHg; Torr: 5.0-250
kPa: 0.67-33.3
Reference range mmHg: 35-48 (m); 32-45 (f)
kPa: 4.67-6.40 (m); 4.27-6.00 (f)
Conversion of units p(kPa) = 0.133322 × p(mmHg) = 0.133322 ×
p(Torr)
p(mmHg) = p(Torr) = 7.500638 × p(kPa)

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ABL90 FLEX reference manual 8. Parameters

pO2 Is used for both blood and expired air samples.

Definition Partial pressure (or tension) of oxygen in blood.
High and low pO2 values of arterial blood indicate
blood hyperoxia and hypoxia, respectively.
Unit mmHg; kPa; Torr
Range of indication mmHg; Torr: 0.0-800
kPa: 0.00-107
Reference range mmHg: 83-108 (m, f)
kPa: 11.07-14.40 (m, f)
Conversion of units p (kPa) = 0.133322 × p(mmHg) = 0.133322 ×
p(Torr)
p(mmHg) = p(Torr) = 7.500638 × p(kPa)

Baro Definition Ambient barometric pressure (p(amb)).

Unit mmHg; kPa; Torr
Range of indication mmHg; Torr: 450-800
kPa: 60.0-106.7
Reference range -
Conversion of units p (kPa) = 0.133322 × p(mmHg) = 0.133322 ×
p(Torr)
p(mmHg) = p(Torr) = 7.500638 × p(kPa)

ctHb Definition Concentration of total hemoglobin in blood.

Total hemoglobin includes all types of hemoglobin:
deoxy-, oxy-, carboxy-, met-.
Unit g/dL; g/L; mmol/L
Range of indication g/dL: –0.48-27.7
g/L: –4.8-277
mmol/L: –0.30-17.2
Reference range g/dL: 13.5-17.5 (m); 12.0-16.0 (f)
g/L: 135-175 (m); 120-160 (f)
mmol/L: 8.4-10.9 (m); 7.4-9.9 (f)
Conversion of units ctHb (g/dL) = 1.61140  ctHb (mmol/L);
ctHb (g/L) = 16.1140  ctHb (mmol/L);
ctHb (mmol/L) = 0.62058  ctHb (g/dL) =
0.062058  ctHb (g/L)
Default value 9.3087 mmol/L, (15.0 g/dL or 150 g/L)

8-7
8. Parameters ABL90 FLEX reference manual

sO2 Can also be calculated: see Derived parameters eq. 39.

Definition Oxygen saturation, the ratio between the
concentrations of oxyhemoglobin and the hemoglobin
minus the dyshemoglobins.
Unit %; fraction
Range of indication %: –2-102
Fraction: –0.02-1.02
Reference range %: 95-99 (m, f)
Fraction: 0.95-0.99 (m, f)
Reference [11]

FO2Hb Can also be calculated: see Derived parameters eq. 40.

Definition Fraction of oxyhemoglobin in total hemoglobin in
blood.
Unit %; fraction
Range of indication %: –2-103
Fraction: –0.02-1.03
Reference range %: 94-98 (m, f)
Fraction: 0.94-0.98 (m, f)

FCOHb Definition Fraction of carboxyhemoglobin in total hemoglobin in

blood.
Unit %; fraction
Range of indication %: –2-103
Fraction: –0.02-1.03
Reference range %: 0.5-1.5 (m, f)
Fraction: 0.005-0.015 (m, f)
Default value 0.004 (0.4 %)

FMetHb Definition Fraction of methemoglobin in total hemoglobin in

blood.
Unit %; fraction
Range of indication %: –2-103
Fraction: –0.02-1.03
Reference range %: 0.0-1.5 (m, f)
Fraction: 0.000-0.015 (m, f)
Default value 0.004 (0.4 %)

8-8
ABL90 FLEX reference manual 8. Parameters

FHHb Can also be calculated: see Derived parameters eq. 41.

Definition Fraction of deoxyhemoglobin in total hemoglobin in
blood.
Deoxyhemoglobin is the part of total hemoglobin
which can bind oxygen forming oxyhemoglobin. It is
also termed reduced hemoglobin, RHb.
Unit %; fraction
Range of indication %: –2-102
Fraction: –0.02-1.02

FHbF Definition Fraction of fetal hemoglobin in total hemoglobin in

blood.
Unit %; fraction
Range of indication %: –25-121
Fraction: –0.25-1.21
Reference range %: 80 (m, f)
(neonates)
Fraction: 0.80 (m, f)

cK+ Definition Concentration of potassium ions in plasma.

Unit mmol/L; meq/L
Range of indication mmol/L; meq/L: 0.5-25.0
Reference range m, f: 3.4-4.5 mmol/L
Conversion of units mmol/L = meq/L

cNa+ Definition Concentration of sodium ions in plasma.

Unit mmol/L; meq/L
Range of indication mmol/L; meq/L: 7-350
Reference range m, f; 136-146 mmol/L
Conversion of units mmol/L = meq/L

cCa2+ Definition Concentration of calcium ions in plasma.

Unit mmol/L; meq/L; mg/dL
Range of indication mmol/L: 0.2-9.99
meq/L: 0.4-19.98
mg/dL: 0.8-40.04
Reference range m, f: 1.15-1.29 mmol/L; 2.30-2.58 meq/L; 4.61-5.17
mg/dL
Conversion of units meq/L = 2 mmol/L
mg/dL = 4.008 mmol/L
Reference [12]

8-9
8. Parameters ABL90 FLEX reference manual

cCl- Definition Concentration of chloride ions in plasma.

Unit mmol/L; meq/L
Range of indication mmol/L; meq/L: 7-350
Reference range 98-106 mmol/L (m, f)
Conversion of units mmol/L = meq/L

cGlu Definition Concentration of D-glucose in plasma.

Unit mmol/L; mg/dL
Range of indication mmol/L: 0-60
mg/dL: 0-1081
Reference range m, f: 3.89-5.83 mmol/L; 70-105 mg/dL
Conversion of units cGlucose (mg/dL) = 18.016  cGlucose (mmol/L)
cGlucose (mmol/L) = 0.055506  cGlucose (mg/dL)

cLac Definition Concentration of L-lactate in plasma.

Unit mmol/L; meq/L; mg/dL
Range of indication mmol/L: –0.1-31
meq/L: –0.1-31
mg/dL: –1-279
Reference range m, f: 0.5-1.6 mmol/L; 4.5-14.4 mg/dL
Conversion of units cLactate (mg/dL) = 9.008  cLactate (mmol/L)
cLactate (mmol/L) = 0.11101  cLactate (mg/dL)
(conversion based on the molecular weight of lactic
acid)

ctBil Definition Concentration of total bilirubin in plasma.

Total bilirubin includes its two forms: conjugated and
unconjugated.
Unit µmol/L; mg/dL; mg/L
Range of indication µmol/L: –20-1000
mg/dL: –1.2-58.5
mg/L: –12-585
Reference range See the table on the next page.
Conversion of units ctBil (µmol/L) = 17.1  ctBil (mg/dL)
ctBil (µmol/L) = 1.71  ctBil (mg/L)
ctBil (mg/dL) = 0.0585  ctBil (µmol/L)
ctBil (mg/L) = 0.585  ctBil (µmol/L)

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ABL90 FLEX reference manual 8. Parameters

The reference ranges are as follows:

Age ctBil
24 hrs, premature 103-205 µmol/L
1.0-8.0 mg/dL
10-80 mg/L
24 hrs, full-term 34-103 µmol/L
2.0-6.0 mg/dL
20-60 mg/L
48 hrs, premature 103-205 µmol/L
6-12 mg/dL
60-120 mg/L
48 hrs 103-171 µmol/L
6-10 mg/dL
60-100 mg/L
3-5 days, premature 171-239 µmol/L
10-14 mg/dL
100-140 mg/L
3-5 days, full-term 68-137 µmol/L
4-8 mg/dL
40-80 mg/L
>1 month 3.4-17 µmol/L
0.2-1.0 mg/dL
2-10 mg/L

The following table shows the possible ranges and precision (number of
decimals) of the measured parameters.
These ranges can be narrowed by calculation ranges, reportable ranges, range
of indication, etc., but should be taken into consideration when external systems
are interfaced to the analyzer.

Symbol Unit Numerical format within the following ranges:

Range Range
pH - 4.000 11.000
cH+ 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
pO2 mmHg 0.0 99.9 100 2250
kPa 0.0 9.99 10.0 99.9 100 300
Baro mmHg 98 1500
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

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8. Parameters ABL90 FLEX reference manual

Symbol Unit Numerical format within the following ranges:

Range Range
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
2+
cCa mmol/L 0.00 50.00
meq/L 0.00 100.00
mg/dL 0.00 200.40
-
cCl mmol/L 0 1000
meq/L 0 1000
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
micromol/L -100 5000
mg/L -58 2923

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ABL90 FLEX reference manual 8. Parameters

Input parameters
Definition Input parameters are the parameters keyed in by the operator on the Patient
Identification screen or transferred from an interfaced database.
All input parameters are given in this section.

T Definition Patient temperature.

Unit °C; °F
Input range °C: 15.0-45.0
°F: 59-113
Conversion 9 o 5 o
T °F = T C  32 ; T C = (T F  32)
5 9

FO2(I) Definition Fraction of oxygen in dry inspired air.

Unit %; fraction
Input range %: 0-100
fraction: 0.000-1.000
Reference range 35.5-44.7 (m, f)

ctHb Is used if the analyzer version does not include the oximetry measuring system.
Definition Concentration of total hemoglobin in blood.
Input range /Unit g/dL: 0.0-33.0
g/L: 0-330
mmol/L: 0.0-20.5
Conversion ctHb (g/dL) = 1.61140  ctHb (mmol/L);
ctHb (g/L) = 16.1140  ctHb (mmol/L);
ctHb (mmol/L) = 0.62058  ctHb (g/dL) =
0.062058  ctHb (g/L)

RQ Definition Respiratory quotient, ratio between the CO2

production and the O2 consumption.
Input range 0.00-2.00

– Definition Oxygen tension of mixed venous blood.

pO2(v )
Input range/Unit mmHg; Torr: 0.0-750.0
kPa: 0.00-100
Conversion p(kPa) = 0.133322  p(mmHg)
p(mmHg) = 7.500638 × p(kPa)

8-13
8. Parameters ABL90 FLEX reference manual

– Definition Oxygen saturation of mixed venous blood.

sO2(v )
Input range/Unit %: 0.0-100.0
fraction: 0.000-1.000

· Definition Cardiac output; volume of blood delivered from

Qt the left ventricle into the aorta per unit of time.
Also termed CO or C.O.
Input range/Unit 0.0-100.0 L/min

· Definition Oxygen consumption; total amount of oxygen

VO2
utilized by the whole organism per unit of time.
Input range/Unit mL/min: 0-21000
mmol/min: 0.0-937.1
Conversion mmol/min = (mL/min)/22.41

VCO Definition Volume of carbon monoxide added to the patient

for measurement and calculation of V(B) [5].
Input range/Unit 0.0-1000.0 mL

FCOHb(1) Definition The fraction of COHb measured before the CO-

injection.
Input range/Unit %: 0.0-100.0
fraction: 0.000-1.000

FCOHb(2) Definition The fraction of COHb measured after the CO-

injection.
Input range/Unit %: 0.0-100.0
fraction: 0.000-1.000

8-14
ABL90 FLEX reference manual 8. Parameters

Derived parameters
General In the Type column the following symbols are used:
information
 ms for measured parameters
 dv for derived parameters
 in for input parameters

Acid-base Symbol Definition Type Eq.

derived
parameters pH(T) pH of blood at patient temperature. dv 1
cH+(T) Concentration of hydrogen ions in blood at dv 2
patient temperature.
pCO2(T) Partial pressure (or tension) of carbon dioxide dv 3
at patient temperature.
cHCO3–(P) Concentration of hydrogen carbonate in plasma dv 4
(also termed actual bicarbonate).
cBase(B) Actual Base Excess, the concentration of titrable dv 5
base when the blood is titrated with a strong
or ABE
base or acid to a plasma pH of 7.40, at pCO2 of
5.33 kPa (40 mmHg) and 37 °C, at the actual
oxygen saturation [4,5,24].
Positive values (base excess) indicate a relative
deficit of non-carbonic acids; negative values
(base deficit) indicate a relative excess of non-
carbonic acids.
cBase(B,ox) cBase(B) of fully oxygenated blood. dv 6
cBase(Ecf) Standard Base Excess, an in vivo expression of dv 7
base excess [5,6,24]. It refers to a model of the
or SBE
extracellular fluid (one part of blood is diluted
by two parts of its own plasma) and is calcu-
lated using a standard value for the hemoglobin
concentration of the total extracellular fluid.
cBase(Ecf,ox) cBase(Ecf) of fully oxygenated blood. dv 8
–
cHCO3 (P,st) Standard Bicarbonate, the concentration of dv 9
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 [4,5].
ctCO2(P) Concentration of total carbon dioxide, (free CO2 dv 10
+ bound CO2) in plasma.
ctCO2(B) Concentration of total carbon dioxide in whole dv 11
blood (also termed CO2 content).
Calculated based on the total CO2
concentrations in the two phases: plasma and
erythrocyte fluid [5].

8-15
8. Parameters ABL90 FLEX reference manual

Symbol Definition Type Eq.

pH(st) Standard pH (or eucapnic pH), defined as dv 12
the pH of plasma of blood equilibrated 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 meta-
bolic status of the blood plasma.
VCO2/V(dry The volume fraction of carbon dioxide in dry dv 51
air) air.

Oximetry Symbol Definition Type Eq.

derived
parameters FHHb Fraction of deoxyhemoglobin in total ms/dv 41
hemoglobin in blood.
Deoxyhemoglobin is the part of total
hemoglobin which can bind oxygen, forming
oxyhemoglobin. It is also termed reduced
hemoglobin, RHb.
FO2Hb Fraction of oxyhemoglobin in total hemoglobin ms/dv 40
in blood.
sO2 Oxygen saturation, the ratio between the ms/dv 39
concentrations of oxyhemoglobin and the
hemoglobin minus the dyshemoglobins.
Hct Hematocrit, the ratio between the volume of dv 13
erythrocytes and the volume of whole blood.

Oxygen derived Symbol Definition Type Eq.

parameters
pO2(T) Partial pressure (or tension) of oxygen at dv 14
patient temperature.
pO2(A) Partial pressure (or tension) of oxygen in dv 15
alveolar air.
pO2 (A,T) Partial pressure (or tension) of oxygen in dv 16
alveolar air at patient temperature.
pO2(a)/ Oxygen tension ratio of arterial blood and the dv 17
FO2(I) fraction of oxygen in dry inspired air
pO2(a,T)/ Oxygen tension ratio of arterial blood at dv 18
FO2(I) patient temperature and the fraction of
oxygen in dry inspired air
p50 Partial pressure (or tension) of oxygen at half dv 19
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 dv 20
saturation (50 %) in blood at patient
temperature.

8-16
ABL90 FLEX reference manual 8. Parameters

Symbol Definition Type Eq.

p50(st) Partial pressure (or tension) of oxygen at half dv 21
saturation (50 %) in blood at standard
conditions: temperature = 37 °C
pH = 7.40
pCO2 = 5.33 kPa
FCOHb, FMetHb, FHbF set to 0
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) dv 22
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) dv 23
of oxygen in alveolar air and arterial blood at
patient temperature.
pO2(a/A) Ratio of the partial pressure (or tension) of dv 24
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 dv 25
oxygen in arterial blood and alveolar air at
patient temperature.
pO2(x) or px Oxygen extraction tension of arterial blood. dv 26
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
[8].
pO2(x,T) or Oxygen extraction tension of arterial blood at dv 50
px(T) patient temperature.
ctO2(B) Total oxygen concentration of blood. dv 27
Also termed O2 content.
– Oxygen concentration difference between dv 28
ctO2(av )
arterial and mixed venous blood.
BO2 Hemoglobin oxygen capacity; the maximum dv 29
concentration of oxygen bound to hemoglobin
in blood saturated, so that all deoxyhemoglobin
is converted to oxyhemoglobin.
ctO2(x) Extractable oxygen concentration of arterial dv 30
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),
maintaining constant pH and pCO2 [8].
· Oxygen delivery; the total amount of oxygen dv 31
D O2 delivered to the whole organism per unit of
time.

8-17
8. Parameters ABL90 FLEX reference manual

Symbol Definition Type Eq.

· Cardiac output; volume of blood delivered from dv/in 32
Qt the left ventricle into the aorta per unit of time.
Also termed CO or C.O.
· Oxygen consumption; total amount of oxygen dv/in 33
VO2
utilized by the whole organism per unit of time.
FO2(I) Fraction of oxygen in dry inspired air. in
FShunt Relative physiological shunt or concentration- dv 34
based shunt [5,8,9].
 Calculated from the pulmonary shunt
equation:

Q 1
s
 
Q ctO2 (a  v)
t 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 difference
in the concentrations of total oxygen in
arterial and mixed venous blood:
ctO2 (a  v)  2.3 mmol/L (5.15 mL/dL)

FShunt (T) FShunt at patient temperature. dv 35

RI Respiratory Index; ratio between the oxygen dv 36
tension difference of alveolar air and arterial
blood and the oxygen tension of arterial blood.
RI(T) Respiratory Index; ratio between the oxygen dv 37
tension difference of alveolar air and arterial
blood and the oxygen tension of arterial blood
at patient temperature.
VO2/V(dry Volume fraction of oxygen in dry air. dv 52
air)
Qx Cardiac oxygen compensation factor of arterial dv 38
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) [5,8].
V(B) Volume of blood, calculated when FCOHb and dv 42
V(CO) values are keyed in [5].

8-18
ABL90 FLEX reference manual 8. Parameters

Units and numerical format of derived parameters

Calculated Derived parameters are calculated or estimated on the basis of measured and
versus keyed-in data. Calculations are made using equations programmed into the
estimated analyzer. The accuracy of the calculations depends on the input parameters
parameters keyed into the analyzer’s computer.
If the calculation of a parameter requires input from the operator, but this input
is not forthcoming, the analyzer will use certain default values (refer to the
section Default values in this chapter).
Not all input parameters are stored as defaults. In these instances the
dependent derived parameter will not be reported if the relevant input
parameter(s) is/are not entered.
If the default values are used in the calculation of a parameter, then a
parameter is considered estimated ("e") rather than calculated ("c").

Electrolyte The table below lists the electrolyte derived parameters for the analyzers.
parameters

Symbol Unit Analyzer Input parameter Sample

type
Anion Gap, K+ meq/L, c2)
mmol/L
Anion Gap meq/L, c3)
mmol/L
cCa2+(7.4) meq/L, c4)
mg/dL,
mmol/L
mOsm mmol/kg c5)

2) If the analyzer includes K+, Na+ and Cl– measurements.

3) If the analyzer includes Na+ and Cl– measurements.
4) If the analyzer includes Ca2+ measurement.
5) If the analyzer includes Na+ and Glucose measurements.

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8. Parameters ABL90 FLEX reference manual

Possible The following table shows the possible ranges and precision (number of
ranges and decimals) of the measured parameters. These ranges can be narrowed by
precision calculation ranges, reportable ranges, range of indication, etc., but should be
(number of taken into consideration when external systems are interfaced to the analyzer.
decimals)
Symbol Unit Numerical format within the following ranges:
Range Range
pH(T) - 4.000 11.000
+
cH (T) nmol/L -999999.0 199.9 200 9999999
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 % -10.0 110.0
air)
fraction -0.100 1.100
Hct % -10.0 110.0
fraction -0.100 1.100
pO2(T) mmHg 0.0 99.9 100 750
kPa 0.00 9.99 10.0 100.0
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

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ABL90 FLEX reference manual 8. Parameters

Symbol Unit Numerical format within the following ranges

Range Range
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)/ mmHg 0.0 99.9 100 7501
FO2(I)
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
– mmol/L 0.0 100.0
ctO2(av )
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
· mL/min 0 22414
D O2
mmol/min 0.0 1000.0
·
Qt L/min 0.0 100.0

·
V O2 mL/min 0 22414
mmol/min 0.0 1000.0

8-21
8. Parameters ABL90 FLEX reference manual

Symbol Unit Numerical format

Range Range
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
VO2/V(dry % -10.0 1.100
air)
fraction -0.100 1.100
V(B) L 0.0 20.0
Anion Gap, mmol/L -500.0 500.0
K+
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

8-22
ABL90 FLEX reference manual 8. Parameters

List of equations
Units and All definitions and equations are based on SI units. If "T" for patient
symbols temperature is not stated, the calculation is based on a temperature of 37.0 °C.
The following SI units are used:
concentration in mmol/L
temperature in °C
pressure in kPa
fractions (not %)

The following symbols are used in the equations:

log(x) = log10(x)
ln(x) = loge(x)

pH(T) Eq. 1 [13]:

pH(T )  pH(37)  0.0147  0.0065  pH(37)- 7.40   T - 37

NOTICE: The formula is different from previous Radiometer analyzers. The

constant 0.0146 is now changed to 0.0147, to be in accordance with NCCLS
(CLSI)-approved guidelines [24].
The change corresponds to –0.1 mpH/°C.

cH+(T) Eq. 2:

cH+(T )=10
9  pH (T )

pCO2(T) Eq. 3 [4]:

0.019T - 37  
pCO2 (T )  pCO2(37)  10 

NOTICE: The formula is different from previous Radiometer analyzers. The

constant 0.021 is now changed to 0.019, to be in accordance with NCCLS (CLSI)-
approved guidelines [24].
The change corresponds to 2%/5 °C.

cHCO3–(P) Eq. 4 [24]:

cHCO-3(P)  0.23  pCO2 10

pH-pKp 

where
pK p 6.095

cHCO3–(P) includes ions of hydrogen carbonate, carbonate and carbamate in the

plasma.
NOTICE: The formula is different from previous Radiometer analyzers. The pKp is
now constant, to be in accordance with NCCLS (CLSI)-approved guidelines [24].
The change corresponds to 5% in the pH range 7-7.8.

8-23
8. Parameters ABL90 FLEX reference manual

cBase(B) Eq. 5 [24]:

cBase(B)  (1  0.014ctHb)(cHCO-3 (P)  24.8  (1.43 ctHb  7.7)(pH  7.4))

NOTICE: The formula is different from previous Radiometer analyzers. The

calculation is done in accordance with NCCLS (CLSI)-approved guidelines [24].
However, since it is assumed that the previous method [14] is a better model,
the previous range checks are retained (no values displayed outside ±50
mmol/L and values tagged with "?" outside the range of ±30 mmol/L).
The change corresponds to less than 0.6 mmol/L in the reference ranges for pH,
pCO2 and ctHb.

cBase(B,ox) Eq. 6 [4]:

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) Eq. 7 [24]:

cBase(Ecf)  cHCO-3(P)  24.8  16.2 (pH  7.4)

See NOTICE in Eq. 5

cBase(Ecf,ox) Eq. 8:
cBase(Ecf,ox) = cBase(Ecf) – 0.3062 × 3 ×(1 – sO2)

cHCO3–(P,st) Eq. 9 [4,14]:

cHCO-3(P,st)  24.47  0.919  Z+Z  a'   Z - 8 

where

Eq. Description
9.1 a'= 4.04  10-3  4.25  104  ctHb

9.2 Z  cBase(B)- 0.3062  ctHb  1- sO2 

ctCO2(P) Eq. 10 [4,5]:

ctCO2(P)  0.23  pCO2  cHCO-3(P)

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ABL90 FLEX reference manual 8. Parameters

ctCO2(B) Eq. 11 [5]:

 pH  pK  
ctCO2(B)  9.286  103  pCO2  ctHb  1+10 Ery Ery 
 
 ctHb 
 ctCO2 (P)  1  
 21.0 

where
Eq. Description
11.1 pHEry  7.19  0.77  pH- 7.40   0.035  1  sO2 

11.2  pH  7.84  0.06sO2  

pKEry  6.095  log 1+10 Ery 
 

pH(st) Eq. 12 [14]:

pH(st): see equations 5.3-5.5 below.

Eq. Description
5.3  5.33   pH(Hb)  pH 
pH(st)  pH  log     
 pCO 2   log p CO2 (Hb)  log(7.5006p CO )
2 

pH(Hb)  4.06  102 ctHb+5.98 -1.92  10

5.4 0.16169ctHb 

5.5 log pCO2(Hb)   1.7674  102 ctHb+3.4046 +2.12  10

0.15158ctHb 

Hct Eq. 13 [15]:

Hct = 0.04939ctHb
Hct cannot be calculated on the basis of a default ctHb value.
NOTICE: The formula is different from the formula used in previous Radiometer
analyzers. The previous formula 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 formulas when ctHb=9.3087 mmol/L.
The change corresponds to 1% in the ctHb range 6.3-12.3.

pO2(T) Eq. 14 [16,17]:

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 46-47
in the section Oxyhemoglobin dissociation curve (ODC) further in this chapter).
pO2(T) is calculated by a numerical method using:

ti(T )  ctHb  1- FCOHb - FMetHb   sO2,i(T )   O2(T )  pO2,i(T )

8-25
8. Parameters ABL90 FLEX reference manual

where
Eq. Description See…
14.1 S = ODC(P,A,T) Eq. 47
14.2 S  1- FMetHb   FCOHb Eq. 46.12
sO2,i(T )=
1-FCOHb-FMetHb
14.3 P Eq. 46.10
pO2,i (T )=
FCOHb
1
sO2,i(T )  1  FCOHb  FMetHb 

14.4  1.1510 2 T -37.0 2.110 4  T -37.0 2 

O2  0.0105 e  

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).

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) Eq. 15 [5]:

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 entering the sample type as "Arterial" or "Capillary".

pO2(A,T) Eq. 16 [4,5,18]:

pO2(A,T )  FO2(I)   p(amb)- pH2O(T )

 pCO2(T )  RQ1  FO2(I)  RQ-1  1 

   

2.36102  T  37.0  9.6 105  T  37.0 2 

     
pH2O(T )=6.275  10

If FO2(I) and RQ are not keyed in, they are set to the default values.
The calculation requires entering the sample type as "Arterial" or "Capillary".

pO2(a)/FO2(I) Eq. 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 entering the sample as "Arterial" or "Capillary".

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ABL90 FLEX reference manual 8. Parameters

pO2(a,T)/ Eq. 18:

FO2(I)
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 entering the sample as "Arterial" or "Capillary".

p50 Eq. 19 Refer to Eq. 46.10:

The ODC is determined as described in equations 46-47 in the section
Oxyhemoglobin Dissociation Curve further in this chapter.
P
p50=
FCOHb
1
0.5  1- FCOHb - FMetHb 

where

Description See...
P = ODC(S,A,T) Eq. 47

0.5  1  FCOHb - FMetHb   FCOHb Eq. 46.11

S
1- FMetHb

A=a
T = 37.0 °C Eq. 46.13

p50(T) Eq. 20:

The ODC is determined as described in equations 46-47 in the section
Oxyhemoglobin Dissociation Curve further in this chapter.
P
p50(T )=
FCOHb
1
0.5  1- FCOHb - FMetHb 

where

Description See…
P = ODC(S,A,T) Eq. 47

0.5  1  FCOHb - FMetHb   FCOHb Eq. 46.11

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)

8-27
8. Parameters ABL90 FLEX reference manual

p50(st) Eq. 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 46-47 in the section
Oxyhemoglobin dissociation curve (ODC), see equation 47 further in this
chapter.
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, Eq. 46.13
FMetHb = 0, FHbF = 0
T = 37.0 °C

pO2(A-a) Eq. 22:

pO2(A  a)= pO2(A)- pO2(a)
The calculation requires entering the sample type as "Arterial" or "Capillary".

pO2(A-a,T) Eq. 23:

pO2(A–a,T)=pO2(A,T)–pO2(a,T)
The calculation requires entering the sample type as "Arterial" or "Capillary".

pO2(a/A) Eq. 24:

pO2(a)
pO2(a/A) 
pO2 (A)

The calculation requires entering the sample type as "Arterial" or "Capillary".

pO2(a/A,T) Eq. 25:

pO2(a, T )
pO2(a/A,T )=
pO2(A,T )
The calculation requires entering the sample type as "Arterial" or "Capillary".

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ABL90 FLEX reference manual 8. Parameters

pO2(x) Eq. 26 [8]:

(or px) The ODC is determined as described in equations 46-47 in the section
Oxyhemoglobin Dissociation Curve further in this chapter.
pO2(x) is calculated by a numerical method, using:

Eq. 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 entering the sample type as "Arterial" or "Capillary".

ctO2 Eq. 27 [5]:

ctO2  O2  pO2  sO2  1  FCOHb  FMetHb   ctHb

O2 is the concentrational solubility coefficient for O2 in blood (here set to

0.0105 mmol/L/kPa at 37 °C [24].
ctO2 cannot be calculated on the basis of a default ctHb value.
NOTICE: The formula is different from previous Radiometer analyzers. The
oxygen solubility coefficient is now changed from 0.00983 to 0.0105 to be in
accordance with NCCLS (CLSI)-approved guidelines [24].
The change corresponds to 0.00067 mmol/L/kPa.

– Eq. 28:
ctO2(av )
– –
ctO2(a  v ) = ctO2(a) – ctO2(v )
where ctO2(a) and
–
ctO2(v ) are calculated from equation 27 for arterial and mixed
venous blood, respectively. The calculation requires two measurements and input
– –
of both pO2(v ) and sO2(v ).

Eq. 29 [7]:

BO2 BO2  ctHb  1  FCOHb  FMetHb 

BO2 cannot be calculated on the basis of a default ctHb value.

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8. Parameters ABL90 FLEX reference manual

ctO2(x) Eq. 30 [8]:

(or cx)
The ODC is determined, as described in equations 46-47 in the section
Oxyhemoglobin Dissociation Curve further in this chapter.
ctO2( x)  ctO2(a)  ti

where

Eq. 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  FCOHb  Eq. 46.9
P  pO2(5)  1  
 sO2,i  1  FCOHb  FMetHb  

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 entering the sample type as "Arterial" or "Capillary".

· Eq. 31:
D O2
. .
D O2  ctO2  Q t
· ·
Q t is the cardiac output and is an input parameter for the calculation of D O2.
· ·
If Q t is not keyed in, D O2 will not be calculated.
The calculation requires entering the sample type as "Arterial" or "Capillary".

· Eq. 32:
Qt
.
. V O2
Qt 
ctO2(a-v)
· ·
If V O2 is not keyed in, Q t will not be calculated.

· Eq. 33:
VO2
. .
V O2  Qt  ctO2(a-v)
· ·
If Q t is not keyed in, VO2 will not be calculated.

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ABL90 FLEX reference manual 8. Parameters

FShunt Eq. 34 [5]:

ctO2(c)  ctO2(a)
FShunt=
ctO2(c)  ctO2 (v)

and

Eq. Description
34.1 ctO2(A)  ctO2(a)
FShunt 
ctO2(A)  ctO2(v)

34.2 
1
ctO2(a)  ctO2(v) 
FShunt= 1  
 ctO2(A)  ctO2 (a) 

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  1  FCOHb  FMetHb   sO2 (a)

34.4 ctO2(A)  0.0105pO2(A)  ctHb 

1  FCOHb  FMetHb   sO2(A)
34.5 ctO2(v)  0.0105 pO2(v)  ctHb 
1  FCOHb  FMetHb   sO2(v)
where:
pO2(a): oxygen tension in arterial blood; measured
pO2(A): oxygen tension in alveolar blood. See equation 15.
–
pO2(v ): 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(v ): oxygen saturation in mixed venous blood; measured and then
entered
The calculation requires entering the sample type 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(v ) = 2.3 mmol/L in equation 34.2

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8. Parameters ABL90 FLEX reference manual

FShunt(T) Eq. 35 [5,16]:

1
 ctO2(a,T )-ctO2(v,T ) 
FShunt(T )= 1  
 ctO2 (A,T )-ctO2 (a,T ) 

where
ctO2(a,T): total oxygen in arterial blood at patient temperature
ctO2(A,T): total oxygen in alveolar blood at patient temperature
–
ctO2(v ,T): total oxygen in mixed venous blood at patient temperature

Eq. Description See…

35.1 ctO2(a,T) = ctO2 calculated from equation 25 for arterial pO2
and sO2 values at 37 oC
35.2 ctO2(A, T )   O2(T )  pO2(A, T )
ctHb  1-FCOHb-FMetHb   sO2 (A,T )

35.3 -1.1510-2  T -37.0  2.1104  T 37.0 2 

     
 O2 (T )  0.0105e

35.4 pO2(A,T) is calculated from equation 16

35.5 sO2(A,T) = S
35.6 S = ODC(P,A,T) Eq. 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(v ) 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(v ,T) = 2.3 mmol/L in equation 35.

RI Eq. 36:

pO2(A)  pO2(a)
RI=
pO2(a)

The calculation requires entering the sample type as "Arterial" or "Capillary".

RI(T) Eq. 37:

pO2 (A, T )  pO2(a, T )
RI(T )=
pO2(a, T )

The calculation requires entering the sample type as "Arterial" or "Capillary".

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ABL90 FLEX reference manual 8. Parameters

Qx Eq. 38 [8]:
The ODC is determined as described in equations 46-47 in the section
Oxyhemoglobin Dissociation Curve further in this chapter.
2.3
Qx 
ctO2(a)  ti

Eq. 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  FCOHb  Eq. 46.9
P  pO2 (5)  1  
 sO2,i  1  FCOHb  FMetHb  

38.5 S  1  FMetHb   FCOHb Eq.

sO2,i  46.12
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 entering the sample type as "Arterial" or "Capillary".

sO2 Eq. 39:

The ODC is determined as described in equation 46 (points I and III). See the
section Oxyhemoglobin dissociation curve (ODC) further in this chapter.

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

FO2Hb Eq. 40:

FO2Hb  sO2  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.

8-33
8. Parameters ABL90 FLEX reference manual

FHHb Eq. 41:

FHHb  1  sO2  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.

V(B) Eq. 42 [5]:

V (CO)
V (B) 
24   FCOHb(2)  FCOHb(1)  0.91  ctHb

Eq. 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

Anion Gap,K+ Eq. 43:

Anion Gap,K+  cNa  cK   cCl  cHCO3

Anion Gap Eq. 44:

Anion Gap  cNa  cCl   cHCO3

cCa2+(7.4) Eq. 45 [12]:

cCa2  (7.4)  cCa2   100.24(7.4pH)

Due to biological variations this equation can only be used for a pH value in the
range 7.2-7.6.
NOTICE: The formula is different from previous Radiometer analyzers. The
previous formula was an approximation of the current formula.
The change corresponds to 1% in the pH range 7.2-7-6.

Eq. 46-47 See Oxyhemoglobin dissociation curve (ODC), further in this chapter.

mOsm Eq. 48 [25]:

mOsm  2cNa  cGlu

FHbF Eq. 49:

An iterative method is used to calculate FHbF. The input parameters are sO2,
ceHb (effective hemoglobin concentration) and cO2HbF (concentration of fetal
oxyhemoglobin).

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ABL90 FLEX reference manual 8. Parameters

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.
Eq. 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
FHbFest 
ceHb

49.6 If FHbFest  0.001, proceed to 49.7.

If FHbFest < 0.001, proceed to 49.9.
49.7 FHbFest, new = FHbFest, old + FHbFest
49.8 Return to 49.2.
49.9 End of iteration. The value for FHbF has converged.

pO2(x,T) Eq. 50 [8,18]:

The ODC is determined as described in equations 46-47 in Oxyhemoglobin
Dissociation Curve further in this chapter.
pO2(x) is calculated by a numerical method, using:

Eq. Description See…

50.1 S = ODC(P,A,T) Eq. 47

50.2 S  1  FMetHb   FCOHb Eq. 46.12

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 ) 

+ O2 (T )  pO2,i(T )

50.5 pH Eq. 20

A  a  1.04   T  37.0 
(T )

50.6 T = patient temperature

O2 (T )  0.0105  e 0.115(T 37) 2110 

50.7 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 "?".

8-35
8. Parameters ABL90 FLEX reference manual

The calculation requires entering the sample type as "Arterial" or "Capillary".

VCO2/V(dry Eq. 51:

air)
pCO2
VCO2 / V (dry air) 
p(amb)  6.275

VO2/V(dry air) Eq. 52:

pO2
VO2 /V (dry air) 
p(amb)  6.275

8-36
ABL90 FLEX reference manual 8. Parameters

Oxyhemoglobin dissociation curve (ODC)

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.
Eq. 46 16,18:

 
y  y o  (x  x o )  h  tanh k o x  x o 
where ko = 0.5343

Eq. Description
46.1 x  ln p
46.2 s
y  ln
1- s

46.3 so
yo  ln where so = 0.867
1-so
46.4 x0 = x00 + a + b = In(p00) + a + b where poo = 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 The reference position of the ODC was chosen to be the one that corresponds to
reference the default value for p50(st) = 3.578 kPa, which is traditionally considered the
position 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

8-37
8. Parameters ABL90 FLEX reference manual

The ODC The ODC displacement which is described by "a" and "b" in the coordinate
displacement 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).

Eq. Description
46.5 p
x  xo  ln ab
7
46.6 h  ho  a where ho = 3.5
46.7 b  0.055  (T  T o ) To = 37 °C

46.8 p  pO2  M  pCO

where M  pCO is taken from the Haldane equation 20:

pO2 pCO
M , to give eq. 46.9
cO2Hb cCOHb

46.9 pO2  FCOHb 

p  pO2   or equation 46.10
sO2  1 - FCOHb - FMetHb 

46.10 p
pO2 
FCOHb
1
sO2  1  FCOHb  FMetHb 

The ordinate, s, may loosely be termed the combined

oxygen/carbon monoxide saturation of hemoglobin and is
described by equation 46.11 below:

Eq. Description
46.11 cO2Hb  cCOHb
s
cO2Hb  cCOHb  cHHb
or
sO2  1-FCOHb-FMetHb   FCOHb

1  FMetHb
46.12 s  1-FMetHb   FCOHb
sO2 
1  FCOHb  FMetHb

8-38
ABL90 FLEX reference manual 8. Parameters

The actual ODC The actual position of the ODC at 37 C for a given sample is, in principle,
position 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).

Eq. 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

Determining Step Description

the actual
displacement I: pO2, sO2 can be used.
If sO2 > 0.97, the calculation is based on II or III – see
below.
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 I.
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".

8-39
8. Parameters ABL90 FLEX reference manual

Step Description
II: sO2 > 0.97 (or erroneous) and p50(st) is known.
Coordinates (P0, S0) are calculated from (p50(st), 0.5)
using equations 46.9 and 46.11.
Reference position of the ODC.

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.

The ODC is further shifted, as determined by the effect

of the measured parameters ("ac"), to its actual posi-
tion. This position reflects the p50(act) of the patient.

(III): sO2 > 0.97 (or erroneous).

Reference position of the ODC.

The position of the actual ODC can now be approxi-

mated from the reference position, using the actual
values of pH, pCO2, FCOHb, FMetHb and FHbF to
determine the shift "ac".

NOTICE: The curves are used only to illustrate the principles of the ODC
determination.

8-40
ABL90 FLEX reference manual 8. Parameters

Coordinates on Calculation of a set of coordinates on the ODC is symbolized by:

the ODC
Eq. 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.

8-41
8. Parameters ABL90 FLEX reference manual

Conversion of units
SI units The equations stated above are based on the SI-unit system. If parameters are
known in other units, they must be converted into a SI unit before entering the
equations. The result will be in an SI unit.
After the calculation the result may be converted to the desired unit. Conversion
of units may be performed, using the equations stated below:

Temperature 9 o
T F = (T C )  32
5

5 o
T C = (T F  32)
9

cK+, cNa+, cCl– cX (meq/L) = cX (mmol/L) where X is K+, Na+ or Cl.

cCa2+ 2  cCa2+ (mmol/L) or

cCa2+ (meq/L) =

cCa2+ (mg/dL) = 4.008  cCa2+ (mmol/L)

cCa2+ = 0.5  cCa2+ (meq/L)or

(mmol/L)

cCa2+ = 0.2495  cCa2+ (mg/dL)

(mmol/L)

Pressure
p 7.500638 × p(kPa)
p (mmHg) = =
(Torr)

p (kPa) = 0.133322 × p(mmHg) = 0.133322 × p(Torr))

ctHb 4
ctHb (g/dL) = 1.61140  ctHb (mmol/L)
ctHb (g/L) = 16.1140  ctHb (mmol/L) or
ctHb (mmol/L) = 0.62058  ctHb (g/dL)
ctHb (mmol/L) = 0.062058  ctHb (g/L)

ctCO2, ctO2, 2.241  (mmol/L)

Vol % =
–
ctO2(av ),
BO2 Vol % = mL/dL

mmol/L = 0.4462  (mL/dL)

· · ·
VO2 VO2 mmol/min = VO2/22.41 mL/min

8-42
ABL90 FLEX reference manual 8. Parameters

cGlu 22

cGlu (mg/dL) = 18.016  cGlu (mmol/L) or

cGlu (mmol/L) = 0.055506  cGlu (mg/dL)

cLac 22

cLac (mg/dL) = 9.008  cLac (mmol/L) or

cLac (mmol/L) = 0.11101  cLac (mg/dL)

cLac (meq/L) = cLac (mmol/L)

(conversion based on the molecular weight of lactic acid)

ctBil ctBil (µmol/L) = 17.1  ctBil (mg/dL)

ctBil (µmol/L) = 1.71  ctBil (mg/L) or
ctBil (mg/dL) = 0.0585  ctBil (µmol/L)
ctBil (mg/L) = 0.585  ctBil (µmol/L)

NOTICE: All conversions of units are made by the analyzer.

8-43
8. Parameters ABL90 FLEX reference manual

Default values
Values The following default values are used in the analyzer, if other values are not
keyed in.

T = 37.0 °C
FO2(I) = 0.21 (21.0 %)
RQ = 0.86
ctHb = 9.3087 mmol/L, (15.00 g/dL or 150 g/L)
FCOHb = 0.004 (0.4 %)
FMetHb = 0.004 (0.4 %)
p50(st) = 3.578 kPa (26.84 mmHg)

In addition to the above default values, the analyzer uses the following default:
Ambient temperature = 25.0 C.

8-44
ABL90 FLEX reference manual 8. Parameters

References
1. The Deep Picture™, critical information from blood gas analysis. Copenhagen:
Radiometer Medical A/S, 1993: 1-14.
2. Wandrup JH. Physicochemical logic and simple symbol terminology of oxygen status.
Blood Gas News 1993; 2,1: 9-11.
3. Siggaard-Andersen O, Durst RA, Maas AHJ. Approved recommendation (1984) on
physicochemical quantities and units in clinical chemistry. J Clin Chem Clin Biochem
1987; 25: 369-91.
4. Siggaard-Andersen O. The acid-base status of the blood. 4th revised ed. Copenhagen:
Munksgaard, 1976.
5. Siggaard-Andersen O, Wimberley PD, Fogh-Andersen N, Gøthgen IH. Measured and
derived quantities with modern pH and blood gas equipment: calculation algorithms with
54 equations. Scand J Clin Lab Invest 1988; 48, Suppl 189: 7-15.
6. Burnett RW, Noonan DC. Calculations and correction factors used in determination of
blood pH and blood gases. Clin Chem 1974; 20,12: 1499-1506.
7. Wimberley PD, Siggaard-Andersen O, Fogh-Andersen N, Zijlstra WG, Severinghaus JW.
Hemoglobin oxygen saturation and related quantities: definitions, symbols and clinical
use. Scand J Clin Lab Invest 1990; 50: 455-59. Available as AS104.
8. 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.
9. Wandrup JH. Oxygen uptake in the lungs. Blood Gas News 1992; 1,1: 3-5.
10. Tietz NW, Logan NM. Reference ranges. In: Tietz NW, ed. Fundamentals of clinical
chemistry. 3rd ed. Philadelphia: WB Saunders Company, 1987: 944-75.
11. Siggaard-Andersen O, Wimberley PD, Fogh-Andersen N, Gøthgen IH. Arterial oxygen
status determined with routine pH/blood gas equipment and multi-wavelength
hemoximetry: reference values, precision and accuracy. Scand J Clin Lab Invest 1990;
50, Suppl 203: 57-66. Available as AS106.
12. 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. Copenhagen:
Radiometer Medical A/S, 1981: 163-90. Available as AS79.
13. Severinghaus JW. Blood gas calculator. J Appl Physiol 1966; 21,3: 1108-16. Available as
ST36.
14. 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.
15. Kokholm G. Simultaneous measurements of blood pH, pCO2, pO2 and concentrations of
hemoglobin and its derivatives – a multicenter study. Scand J Clin Lab Invest 1990; 50,
Suppl 203: 75-86. Available as AS107.
16. Siggaard-Andersen O, Wimberley PD, Gøthgen IH, Siggaard-Andersen M. A mathematical
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.
17. 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.
18. 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.
19. Bartels H, Christoforides C, Hedley-Whyte J, Laasberg L. Solubility coefficients of gases.
In: Altman PL, Dittmer DS, eds. Respiration and circulation. Bethesda, Maryland: Fed
Amer Soc Exper Biol, 1971: 16-18.
20. Roughton FJW, Darling RC. The effect of carbon monoxide on the oxyhemoglobin
dissociation curve. Am J Physiol 1944; 141: 17-31.

8-45
8. Parameters ABL90 FLEX reference manual

21. Engquist A.. Fluids electrolytes nutrition. Copenhagen: Munksgaard, 1985: 56-68, 118.
22. 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.
23. Kokholm G, Larsen E, Jensen ST, ChristiansenTF. 3rd ed. Blood gas measurements at
high altitudes. Copenhagen: Radiometer Medical A/S, 1991. Available as AS109.
24. Blood gas and pH analysis and related measurements; approved guideline. NCCLS (CLSI)
document C46-A2, Vol. 29 No. 8, 2009
25. Burton DR. Clinical physiology of acid-base and electrolyte disorders. 4th ed. New York:
McGraw-Hill, 1994

8-46
 9. Solutions
General information ......................................................................... 9-2
Solutions ........................................................................................ 9-3
Certificate of traceability ................................................................... 9-5
9. Solutions ABL90 FLEX reference manual

General information
Introduction The ABL90 FLEX analyzer utilizes a solution pack for all calibrations, QC and
rinse procedures, and for the collection of waste fluids.

Solution pack The solution pack contains eight foil pouches:

 Three with calibration solution
 One with a gas mixture
 Three with quality control solution
 One for waste
One of the calibration solutions (CAL 1) is also used for rinse.
Calibration solutions and QC solutions in the solution pack have a unique lot
number. Assigned values for the QC solutions are unique for each individual
solution pack because they are adjusted according to the lifetime of the solution
pack when installed on the analyzer.

Lot Each solution pack has a lot number, which identifies the solution packs
assembled in one production lot.

In vitro All the solutions described in this chapter are for in vitro diagnostic use.
diagnostic use

Expiration date The expiration date of the solution pack is found on the solution pack barcode
label. A solution pack can be used on the analyzer for up to 30 days (or until no
more activities are left) but not after the expiration date. This means that if you
install a solution pack 5 days before the expiration date, it can only be used for
5 days.

Storage The solution pack storage temperature range is 2-25 °C. The storage altitude
range is sea level to 4000 meters. The barometer pressure should lie between
450-800 mmHg, or 60.0-106.7 kPa, or 450-800 Torr.

Material safety Material Safety Data Sheets (MSDS) for all solutions in the solution pack are
Data Sheets available from your Radiometer distributor.

9-2
ABL90 FLEX reference manual 9. Solutions

Solutions
Use The solutions contained in the pouches of the solution pack are used for either
calibration or quality control of all analytes. During sample analysis and quality
control measurements CAL 1 also acts as a rinse solution, removing the sample
from the sensor cassette measuring chamber.

Pouch volume Solution Volume

(mL)
S1920 CAL 1 200
S1930 CAL 2 100
S1940 CAL 3 100
S9030 QC 1 200
S9040 QC 2 100
S9050 QC 3 100
Gas mixture 150 *)
*) at sea level

Composition Solution compositions include organic buffers, inorganic salts, surfactant,

metabolites, preservatives, anti-coagulant, enzyme and colorant which provide
the following substances with approximate concentrations as given below:

Concentration
Substance Unit CAL 1 CAL 2 CAL 3
S1920 S1930 S1940
pH 7.30 6.8 NA
pCO2 mmHg 35 NA 80
pO2 mmHg 180 NA NA
cNa+ mmol/L 150 70 NA
+
cK mmol/L 4 10 NA
cCl– mmol/L 95 50 NA
2+
cCa mmol/L 0.5 2.3 NA
cGlu mmol/L 0 NA 10
(background)
cLac mmol/L 0 NA 10
(background)
ctHb g/dL NA NA 0

NOTICE: The actual analyte concentrations for each solution in a solution pack
lot are included in the smart chip contained in each solution pack. The values
are read into the analyzer when the solution pack is installed in an analyzer.

9-3
9. Solutions ABL90 FLEX reference manual

Concentration
Substance Unit S9030 S9040 S9050
(QC 1) (QC 2) (QC 3)
Solution Solution Gas pO2 Solution
(at 760
mmHg)
pH 7.2 6.8 NA 7.5
pCO2 mmHg 30 67 NA 15
pO2 mmHg 180 300 20
(42.07 %)
cNa+ mmol/L 140 118 NA 175
+
cK mmol/L 4 7 NA 1.8
–
cCl mmol/L 105 95 NA 125
cCa2+ mmol/L 0.8 1.65 NA 0.3
cGlu mmol/L 0 15 NA 7
cLac mmol/L 0 8 NA 4
ctHb mmol/L 0 8 NA 12
sO2 % 97 NA 70
FO2Hb % 92 NA 49
FCOHb % 3 NA 20
FMetHb % 2 NA 10
FHbF % 80 NA 50
ctBil µmol/L 0 300 NA 450

NOTICE: The actual analyte concentrations for each solution in a solution pack
lot are included in the smart chip contained in each solution pack. The values
are read into the analyzer when the solution pack is installed in an analyzer.

9-4
ABL90 FLEX reference manual 9. Solutions

Certificate of traceability

9-5
9. Solutions ABL90 FLEX reference manual

9-6
 10. Messages

List of analyzer messages..................................................................10-2

10-1
10. Messages ABL90 FLEX reference manual

List of analyzer messages

Messages on The following messages will be seen on the user and manager levels. The
user and messages are listed in numerical order.
manager levels
Operator actions are listed in order of priority. Perform the first action in the list;
if unsuccessful, try the next action, etc.
In case of analyzer error or malfunction, the error will be logged in the Activity
log.
Do the following:

Step Action
1. Open the Activity log.
2. Find the relevant error.
3. Highlight it by touching the screen.
4. Press Troubleshoot.
5. Follow the procedures given to remedy the error.

The following table describes possible errors and how to remedy them.
NOTICE: The list contains all possible errors and may thus list errors that will
not be relevant for all analyzer variants. Furthermore, operator actions are in
relation of the analyzer and may differ from local procedures in your institution.
In that case, follow local procedures.

10-2
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

1 Inconsistent Inconsistent software - Contact Radiometer

software versions for different service representative.
versions. Please modules. May appear after
Removal condition:
contact service replacing a complete module
or as a result of an - Successful software
incomplete software consistency check.
upgrade.

83 Value above The parameter value is - No action required.

reference range above the user-defined
reference range.
This is only a message, not
an error.

84 Value below The parameter value is below - No action required.

reference range the user-defined reference
range.
This is only a message, not
an error.

85 Value below The parameter value is below - No action required.

critical limit the user-defined critical limit.
This is only a message, not
an error

86 Value above The parameter value is - No action required.

critical limit above the user-defined
critical limit.
This is only a message, not
an error.

89 Measured QC The measured parameter - Verify the procedure

value above value is above the control and repeat the
control range range. measurement.
- Refer to the ABL90
FLEX reference
manual.*

90 Measured QC The measured parameter - Verify the procedure

value below value is below the control and repeat the
control range range. measurement.
- Refer to the ABL90
FLEX reference
manual.*

93 Value above The parameter value is - Check for and remedy

reportable range above the reportable range. other errors 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.

* The ABL90 FLEX reference manual includes a quality control appendix for
manual QC.

10-3
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

94 Value below The parameter value is below - Check for and remedy
reportable range the reportable range. other errors 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 - Check the

connection configuration or the protocol communication
configuration definition was invalid. parameters specified in
Communications Setup.

128 LIS/HIS: Failed The communication hardware - Check that the remote
to open was busy or the remote system is running,
connection system did not respond. 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 Messages were queued when - If the problem

to close the communication channel persists, check the
connection was closed. Results and communication
other messages sent by the hardware. The remote
analyzer to a remote system system may lack buffer
may be lost. capacity.

131 LIS/HIS: Failed A communication error - Check that the remote

to send packet occurred while sending a system is running and
message. The message was responding.
not sent. - Check the
communication
hardware, including
cables.
- Repeat sending.

132 LIS/HIS: Failed An error occurred while - Check that protocol

to receive packet receiving a message. The types are correctly
analyzer was not able to configured on both the
recognize the received analyzer and the remote
massage. system.
- Contact Radiometer
service representative.

133 LIS/HIS: A previously established - Check that the remote

Connection lost LIS/HIS connection has been system is running and
lost. responding.
- Check cables.

134 LIS/HIS: The connection was - No action required. For

Connection successfully established. information only.
established

10-4
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

165 LIS/HIS: High- An error occurred while - Check protocol

level protocol formatting a message. configurations.
could not Contact Radiometer
generate high- service representative.
level packet

166 LIS/HIS: General An internal error occurred in - Contact Radiometer

communication the LIS/HIS communication service representative if
error module. the problem persists.

167 LIS/HIS: High- An error occurred while - Check protocol

level protocol parsing (interpreting) a configurations.
received packet message. Contact Radiometer
in wrong format service representative.

200 User msg: This is only a message. An - No action required.

operator has entered a note
in the log.

201 Westgard Rule Measured parameter value is - Verify procedure and

(1.2s) violation outside the mean +/- 2 SD repeat measurement.
range. - Check Replacement
Status for pending
replacements.
- Refer to the ABL90
FLEX reference manual
for detailed evaluation
procedure.

202 Westgard Rule Measured parameter value is - Verify procedure and

(1.3s) violation outside the mean +/- 3 SD repeat measurement.
range. - Check Replacement
Status for pending
replacements including
electrodes.
- Refer to the ABL90
FLEX reference manual
for detailed evaluation
procedure.

203 Westgard Rule Two consecutive - Verify procedure and

(2.2s) violation measurements are outside repeat measurement.
the mean +/- 2 SD range on - Check Replacement
the same side of the mean. Status for pending
This may indicate a shift. replacements including
electrodes.
- Refer to the ABL90
FLEX reference manual
for detailed evaluation
procedure.

204 Westgard Rule The difference between two - Verify procedure and
(R.4s) violation consecutive measurements repeat measurement.
exceeds 4 SD. This may - Check Replacement
indicate an inconsistency in Status for pending
your procedure or an electrode replacements.
unstable analyzer. - Refer to the ABL90
FLEX reference manual
for detailed evaluation
procedure.

10-5
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

205 Westgard Rule Four consecutive - Check for excessive

(4.1s) violation measurements are outside electrode sensor
the mean +/- 1 SD range on calibration drift.
the same side of the mean. A - Check Replacement
trend or shift is indicated. Status for pending
Patient results should be electrode replacements.
considered unreliable until - Refer to ABL90 FLEX
the problem is remedied. reference manual for
evaluation procedure.

206 Westgard Rule Ten consecutive - Check the electrode

(10.x) violation measurements are on the drift during last
same side of the mean. A calibration.
trend or shift is indicated. - Check Replacement
Patient results should be Status for pending
considered unreliable until electrode replacements.
the problem is remedied. - Refer to ABL90 FLEX
reference manual for
evaluation procedure.

207 Calibration One or more scheduled - Check the Calibration

schedule calibrations are overdue. Status and perform any
reminder(s) pending calibrations.
present

208 Quality control One or more scheduled QC - Check the Quality

schedule measurements are overdue. Control Status and
reminder(s) perform the pending
present quality control.

209 Replacement One or more scheduled - Check the

schedule replacements are overdue. Replacement Status and
reminder(s) perform any pending
present replacement actions.

210 Calibration An error registered on one or - Check Calibration

error(s) present more parameters during the Status for errors in
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 - Check Quality Control
error(s) present registered during last QC Status for errors. View
measurement on one of the QC error messages and
installed QC levels. take required corrective
action.

212 System One or more systems errors - Check the System

message(s) are present. Messages Status for
present errors. Take corrective
required action.

213 Automatic An error occurred during the - Check Automatic

backup failed scheduled data backup. Backup Setup.
- Check network and
servers used for the
backup.
- Contact your IT
engineer.

10-6
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

214 Automatic The scheduled automatic - No action required.

backup backup was completed
succeeded successfully.

216 General printer A printer problem has - Check printer paper.

error occurred, e.g. the paper is Clear any jam.
jammed
- Power down and
restart the analyzer.
- Contact Radiometer
service representative.

217 Replacement: The message is used in the - No action required.

Activity Log to indicate a
performed replacement.

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

291 SHb too high Detected FSHb is greater - Repeat the

than 10%. Measurement measurement.
accuracy is affected.

292 Turbidity too Turbidity is greater than 5 - Hyperlipemic sample;

high %: too high for reliable decrease the lipemic
measurements. content by e.g.
centrifuge or extraction.
- Perform the
measurement on a
blood sample from a
healthy donor.
- Contact Radiometer
service representative.

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

329 QC expiration The quality control - Discontinue the use of

date exceeded measurement was performed the lot and set up a
on an expired control valid lot for the control
solution. solution.

331 No sample No sample detected in - Ensure that adequate

detected during sensor. sample volume is used.
sample aspiration Measurement is aborted. - Check the sample for
clots.

10-7
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

357 Temp. error: Temperature in the - Ensure that the

Barometer barometer on the Analyzer ambient temperature is
Control is outside between 15 and 32 °C.
37 +/- 1.0 °C. - If the system has just
performed a cold start,
wait for the error to
disappear.
- Replace the fan filter,
if dirty.
- Shield the analyzer
from direct sunlight and
other heat sources.
- Contact Radiometer
service representative.

375 Calibration status The status value is outside - Check for and remedy
out of limits the range for the given any system messages.
parameter. - Repeat the calibration.
- Check solution pack
status and replace, if
necessary.
- Check sensor cassette
status and replace, if
necessary.
Removal condition:
- Successful calibration.

376 Calibration Drift The Drift 1 value exceeds the - Check for and remedy
1 out of range tolerance. any system messages.
- Repeat the calibration.
- Check solution pack
status and replace, if
necessary.
- Check sensor cassette
status and replace, if
necessary.
Removal condition:
- Successful calibration.

377 Calibration Drift The Drift 2 value exceeds the - Check for and remedy
2 out of range tolerance. any system messages.
- Repeat the calibration.
- Check solution pack
status and replace, if
necessary.
- Check sensor cassette
status and replace, if
necessary.
Removal condition:
- Successful calibration.

10-8
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

378 Calibration The sensitivity value is out of - Check for and remedy
sensitivity out of range for the given any system messages.
range parameter. - Repeat the calibration.
- Check solution pack
status and replace, if
necessary.
- Check sensor cassette
status and replace, if
necessary.
Removal condition:
- Successful calibration.

379 Calibration An electrode response fault - Check for and remedy

unstable occurred during calibration. any system messages.
(response fault) - Repeat the calibration.
- Check solution pack
status and replace, if
necessary.
- Check sensor cassette
status and replace, if
necessary.
Removal condition:
- Successful calibration.

443 Ca(7.4) not cCa2+ at a pH of 7.4 is not - No action required.

usable usable as the actual pH is
outside the 7.2-7.6 range.

452 Interference Interference was detected - Check the patient

during during measurement. record for medication
measurement containing possible
interfering substances.

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

487 A new statistical A new statistical month has - Make a WDC report
month has begun begun. disk.
- remember to
Removal condition:
export WDC data
- A WDC report disk has
been made.

494 Bilirubin too high Detected bilirubin - No action required.

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

10-9
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

508 Liquid transport Liquid transport of Rinse - Check solution pack or

error during rinse failed sensor cassette status
and replace, if
necessary.
Removal condition:
- Successful Rinse.

512 Temperature The temperature was outside - Ensure that the

error the required range during ambient temperature is
measurement or calibration. between 15 and 32 °C.
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 representative.

521 Inhomogeneous Air bubbles were detected in - Repeat the

sample the sample. Results may measurement.
have "?".

522 Calibration error One or more calibration - Check for and remedy
values are erroneous. any system messages.
- Repeat the calibration.
- Check solution pack
status and replace, if
necessary.
- Check sensor cassette
status and replace, if
necessary.
Removal condition:
- Successful calibration

523 Calibration drift Calibration drift exceeds - Check for and remedy
out of range defined limits. any System 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.
Removal condition:
- Calibration drift within
defined limits.

10-10
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

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

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

537 OXI LS failed to OXI module liquid sensor - Repeat the liquid
calibrate failed to calibrate. sensor calibration.
- Check solution pack
status and replace, if
necessary.
- Contact Radiometer
service representative.

581 OXI spectrum Spectrum deviates from the - Check the patient
mismatch expected blood or QC record for medication
spectrum. Measurement may containing possible
be unreliable. interfering substances.
- Start a calibration.
- Contact Radiometer
service representative.

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

cuvette factor - Repeat the tHb
outside limits calibration.
- Contact Radiometer
service representative.
Removal condition:
- Successful tHb
calibration.

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

wavelength - Repeat the tHb
outside limits calibration.
- Contact Radiometer
service representative.
Removal condition:
- A successful tHb
calibration

588 Measured QC The parameter value is below - Verify the procedure

value lower than the lower limit of the user- and repeat the
statistical range defined statistical range. measurement.
Measurement is not included - Refer to the ABL90
in statistics. FLEX reference manual
for details on the
evaluation of the
results.

10-11
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

589 Measured QC The parameter value is - Verify the procedure

value higher than above the upper limit of the and repeat the
statistical range user-defined statistical measurement.
range. Measurement not - Refer to the ABL90
included into statistics. FLEX reference manual
for details on the
evaluation of the
results.

593 Insufficient Sample volume is too small - Repeat the

sample for the selected measuring measurement, ensuring
mode. Affected parameters sufficient sample
will be marked with "?". volume.
- Contact Radiometer
service representative.

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

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

608 Cal expired Too long time passed since - Perform a calibration.
(pCO2) the last successful calibration
Removal condition:
of the parameter. Parameter
measurement values are - Successful 2-point
reported as ".....". calibration.

609 Cal expired (pO2) Too long time passed since - Perform a calibration.
the last successful calibration
Removal condition:
of the parameter. Parameter
measurement values are - Successful 2-point
reported as ".....". calibration.

610 Cal expired (K) Too long time passed since - Perform a calibration.
the last successful calibration
Removal condition:
of the parameter. Parameter
measurement values are - Successful 2-point
reported as ".....". calibration.

611 Cal expired (Na) Too long time passed since - Perform a calibration.
the last successful calibration
Removal condition:
of the parameter. Parameter
measurement values are - Successful 2-point
reported as ".....". calibration.

612 Cal expired (Ca) Too long time passed since - Perform a calibration.
the last successful calibration
Removal condition:
of the parameter. Parameter
measurement values are - Successful 2-point
reported as ".....". calibration.

10-12
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

613 Cal expired (Cl) Too long time passed since - Perform a calibration.
the last successful calibration
Removal condition:
of the parameter. Parameter
measurement values are - Successful 2-point
reported as ".....". calibration.

614 Cal expired (Glu) Too long time passed since - Perform a calibration.
the last successful calibration
Removal condition:
of the parameter. Parameter
measurement values are - Successful 1- or 2-
reported as ".....". point calibration.

615 Cal expired (Lac) Too long time passed since - Perform a calibration.
the last successful calibration
Removal condition:
of the parameter. Parameter
measurement values are - Successful 1- or 2-
reported as “…..”. point calibration.

616 Cal expired (OXI) Too long time elapsed since - Perform a calibration.
the last successful calibration
Removal condition:
of the parameter. Parameter
measurement values are - Successful 1- or 2-
reported as ".....". point calibration.

641 ABL/DMS PC The analyzer was restarted - No action required.

restarted from power off. For information only.

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

connected to wet connection to the wet section
section is obtained.

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

648 Calibration failed The last calibration was - Check solution pack
or not accepted aborted or not accepted. status and replace, if
necessary.
- Check sensor cassette
status and replace, if
necessary.
- Check for and remedy
system messages.
- Repeat the calibration.
Removal condition:
- Successful calibration.

662 Barometer out of Measured barometer value is - Contact Radiometer

range outside the measuring range: service representative.
60-106.7 kPa.

669 QC value outside Measured parameter value is - Verify the procedure

control range outside control range. and repeat
measurement.
- Refer to Quality
Control Systems
Reference Manual.

10-13
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

679 Barometer error The measured parameter - Contact Radiometer

may be unreliable due to service representative.
barometer error.

682 OXI module not The OXI module is not - Shut down the
active responding due to an internal analyzer, using the
communication problem, or Temporary Shutdown
the software configuration function; then restart it.
does not match the analyzer - Contact Radiometer
type. service representative.
Removal condition:
- OXI module ready, or
software configured
without OXI module
support.

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

692 ABL not The analyzer is not - Contact your

connected to connected to RADIANCE. RADIANCE/IT engineer.
RADIANCE - Check RADIANCE
Communication Setup
including TCP/IP
address, port no. and
password.
- Check that RADIANCE
is responding.
- Check network
connections.
Removal condition:
- RADIANCE connection
established or disabled.

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

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

RADIANCE RADIANCE.

695 ABL disconnected The analyzer was - No action required.

from RADIANCE disconnected from
RADIANCE.

696 ABL<>RADIANCE Communication error - Contact Radiometer

communication between the analyzer and service representative.
error RADIANCE.

10-14
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

699 Built-in QC The analyzer was set up to - Check Calibration

measurement perform built-in QC Status and remedy any
started due to measurements in case of reported calibration
calibration error calibration errors. errors.

700 Scheduled built- Last calibration contained an - Check Calibration

in QC not run error, and the analyzer was Status and remedy
due to errors in set up to suspend built-in QC calibration errors.
last calibration measurements in case of
calibration errors.

703 QC expired QC measurement is 25 % - Perform a quality

overdue (corrective action control measurement.
"Lock analyzer" has been
Removal condition:
selected in the Setup
program: Corrective - No QC measurements
Actions). are pending.

704 Built-in QC The scheduled QC - No action required.

measurement is measurement was not
repeated accepted; the measurement
was repeated as requested in
the Setup program:
Corrective Actions.

705 Built-in QC The scheduled QC - No action required.

measurement is measurement was not
repeated twice accepted; the measurement
was repeated twice as
requested in the Setup
program: Corrective Actions.

707 Replacement(s) Replacement is overdue by - Check Replacement

overdue by 10 10 % (corrective action "Lock Status and replace as
%. Analyzer analyzer" was selected in the required.
locked. Setup program: Corrective - Unlock analyzer in the
Actions). When the analyzer Miscellaneous Setup
is locked, scheduled program.
calibrations are performed,
Removal condition:
but no patient samples or QC
measurements are allowed. - No replacement
pending.

708 Corrective action Scheduled built-in QC - Insert a new solution

not possible due measurement was pack.
to empty solution requested, but the solution
pack pack was empty.

712 FHbF Composition of the blood - If FHbF is wanted

measurement sample makes FHbF change sample
not possible measurement too inaccurate, composition. For
but OXI parameters are example, elevate sO2
compensated for HbF. and tHb.
See explanation in the ABL90
FLEX reference manual.

713 ctBil Blood sample ctHb is so high - If ctBil is wanted,

measurement that hardly any plasma is left lower the ctHb value.
not possible to measure plasma bilirubin
on.
ctHb > 15.5 mmol/L.

10-15
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

734 General WSM The data management - Wait a few minutes for
exception system establishes the connection to
connection to the analyzing establish.
unit, or the connection is - Restart the analyzer.
lost. - If the error persists,
contact Radiometer
service representative.

745 Low disk space Free disk space is low. - Move archive files to
another storage device.
Removal condition:
- Sufficient free hard
disk space.

766 ABL not The analyzer has been - Contact RADIANCE/IT

connected to refused connection to engineer or Radiometer
RADIANCE - no RADIANCE because there is service representative.
RADIANCE no connection license
Removal condition:
connection available on RADIANCE.
license - Connection to
RADIANCE established.

767 ABL not The analyzer has been - Contact RADIANCE/IT

connected to refused connection to engineer or Radiometer
RADIANCE - ABL RADIANCE because the ABL service representative.
StatLink version StatLink version is higher
Removal condition:
too high than the RADIANCE StatLink
version. - RADIANCE connection
established.

768 ABL not The analyzer has been - Contact RADIANCE/IT

connected to refused connection to engineer or Radiometer
RADIANCE - ABL RADIANCE because the ABL service representative.
StatLink version StatLink version is lower
Removal condition:
too low than the RADIANCE StatLink
version. - RADIANCE connection
established.

769 ABL<>RADIANCE Communication error - Contact RADIANCE/IT

communication between the analyzer and engineer or Radiometer
error - XML RADIANCE. service representative.
packet could not
be parsed

770 Failed to restore The setup could not be - Download the setup
Custom Setup restored. data from another
floppy disk, hard disk or
network drive.
- Contact Radiometer
service representative if
the error persists.

771 Succeeded to Restoring of setup is - No action required.

restore Custom completed.
Setup

772 User Activity: User activity logged by - No action required.

operator.

10-16
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

773 Remote operator A remote operator has - No action required.

logged on with logged on the analyzer via
user: NetOp.

774 Remote operator An operator, remotely logged - No action required.

logged off with on via NetOp, has logged off,
user: or has been logged off by a
local operator.

775 Failed to restore Restoring analyzer setup to - Contact Radiometer

Default Setup default values has failed. service representative.

776 Succeeded to Restoring setup to default - No action required.

restore Default values is completed.
Setup

780 RADIANCE RADIANCE communication - No action required. For

communication has been enabled as part of information only.
enabled the RADIANCE Connection
Setup.

781 RADIANCE RADIANCE communication - No action required. For

communication has been disabled as part of information only.
disabled the RADIANCE Connection
Setup.

782 RADIANCE The output queue was - No action required. For

output queue cleared in the RADIANCE information only.
cleared Connection Setup.

783 Automatic Automatic backup (selected - No action required. For

backup started in Disk Functions Setup) has information only.
started.

785 Automatic Automatic archiving (selected - No action required. For

archiving started in Disk Functions Setup) has information only.
started.

786 Automatic Automatic archiving (selected - No action required. For

archiving in Disk Functions Setup) information only.
completed completed successfully.

787 Export of data Export of data logs was - No action required. For
logs started started by the user. information only.

798 User logged on User logged on successfully. - No action required. For

information only.

799 User logged off User logged off. - No action required. For
information only.

800 Logon attempt User tried to log on but did - Provide a valid
failed not provide a valid password. password to log on.

810 pH locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

10-17
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

811 pCO2 locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

812 pO2 locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

813 K locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

814 Na locked The parameter has been Await corrective actions

locked by a RADIANCE initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

815 Cl locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

816 Ca locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

818 Glu locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

10-18
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

819 Lac locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

820 tHb locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

821 MetHb locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

822 COHb locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

823 HHb locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

824 O2Hb locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

825 sO2 locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

10-19
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

826 HbF locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

827 tBil locked The parameter has been - Await corrective

locked by a RADIANCE actions initiated by the
operator, as reflected in the RADIANCE operator.
Activity Log.
Removal condition:
When a parameter is locked,
presumably due to problems - Determined by the
with QC, the parameter is RADIANCE operator.
repressed in patient results.

831 pH unlocked The message is used in the - No action required. For

Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

832 pCO2 unlocked The message is used in the - No action required. For
Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

833 pO2 unlocked The message is used in the - No action required. For
Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

834 K unlocked The message is used in the - No action required. For

Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

835 Na unlocked The message is used in the - No action required. For

Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

836 Cl unlocked The message is used in the - No action required. For

Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

837 Ca unlocked The message is used in the - No action required. For

Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

839 Glu unlocked The message is used in the - No action required. For
Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

840 Lac unlocked The message is used in the - No action required. For
Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

10-20
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

841 tHb unlocked The message is used in the - No action required. For
Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

842 MetHb unlocked The message is used in the - No action required. For
Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

843 COHb unlocked The message is used in the - No action required. For
Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

844 HHb unlocked The message is used in the - No action required. For
Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

845 O2Hb unlocked The message is used in the - No action required. For
Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

846 sO2 unlocked The message is used in the - No action required. For
Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

847 HbF unlocked The message is used in the - No action required. For
Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

848 tBil unlocked The message is used in the - No action required. For
Activity Log to indicate that a information only.
previously locked parameter
has been unlocked.

852 RADIANCE: Message from RADIANCE. - No action required. For

information only.

855 Base Excess out Base Excess exceeds the +/- - For information only.
of range 30 mmol/L range. No analyzer error was
detected.

875 Sample aged The specified limit for sample - Draw and analyze new
age has been exceeded. sample.

885 Cyclic QC The cyclic QC schedule has - No action required. For

schedule reset been reset and all related information only.
from RADIANCE reminders have been
removed as a result of a
RADIANCE command.

886 LIS/HIS: No valid A file with a valid Device ID - Contact Radiometer

POCT1A DML does not exist. A valid Device service representative
Device ID file ID is needed in order to use to obtain a Device ID
the POCT1A DML protocol. file.
Removal condition:
- Valid Device ID found.

10-21
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

963 Leak current in Leak currents were detected - Replace inlet

analyzer during system calibration and connector, sensor
detected may distort measuring cassette or solution
results. pack.
- Contact Radiometer
service representative.

964 Leak current in Leak currents were detected - Replace solution pack.
relation to during system calibration and
- Contact Radiometer
solution pack may distort measuring
service representative.
detected results.

970 Replace solution This message is shown when - Replace solution pack.
pack the solution pack needs to be
replaced. The analyzer will
enter "User-intervention
required".

971 Replace sensor This message is shown when - Replace sensor

cassette the sensor cassette needs to cassette.
be replaced. The analyzer
will enter "User-intervention
required".

973 Printer paper No more paper in printer. - Insert new printer

must be replaced paper.

978 Flow selector Shown in the Activity Log - The analyzer will
calibration error when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

979 Inhomogeneous Shown in the Activity Log - The analyzer will

rinse solution when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

983 Inhomogeneous Shown in the Activity Log - The analyzer will

cal 3 solution when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

984 The analyzer Shown in the Activity Log - The analyzer will
could not when "User-intervention automatically enter
aspirate required" has been entered "User-intervention
homogeneous due to this reason. required". Follow the
calibration instructions shown on
solution the screen.

1000 Number of pO2 Can be shown on a result if - Restart the analyzer.

hardware data unable to calculate oxygen - Perform a calibration.
fail due to an unexpected system - Contact Radiometer
error. service representative.

10-22
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

1001 Timeout while Can be shown on a result if - Restart the analyzer.

waiting for pO2 unable to calculate oxygen - Perform a calibration.
hardware data due to an unexpected system - Contact Radiometer
error. service representative.

1002 pO2 dark data is Can be shown on a result if - Restart the analyzer.
out of range unable to calculate oxygen - Perform a calibration.
due to an unexpected system - Contact Radiometer
error. service representative.

1004 Unable to Can be shown on a result if - Restart the analyzer.

calculate oxygen unable to calculate oxygen - Perform a calibration.
parameter due to an unexpected system - Contact Radiometer
error. service representative.

1005 Unable to Can be shown on a result if - Restart the analyzer.

calculate oxygen unable to calculate oxygen - Perform a calibration.
parameter due to an unexpected system - Contact Radiometer
error. service representative.

1006 Unable to Can be shown on a result if - Restart the analyzer.

calculate oxygen unable to calculate oxygen - Perform a calibration.
parameter due to an unexpected system - Contact Radiometer
error. service representative.

1007 Missing oxygen No calibration data exists for - Perform a calibration.

calibration oxygen.

1008 Unable to Can be shown on a result if - Restart the analyzer.

calculate oxygen unable to calculate oxygen - Perform a calibration.
parameter due to an unexpected system - Contact Radiometer
error. service representative.

1009 Unable to Can be shown on a result if - Restart the analyzer.

calculate oxygen unable to calculate oxygen - Perform a calibration.
parameter due to an unexpected system - Contact Radiometer
error. service representative.

1010 Oxi data Oxi hardware problem - Restart the analyzer.

collection error - Perform a calibration.
- Contact Radiometer
service representative.

1011 Oxi has no Blank Missing Blank Cal. Not - Perform a calibration.
Cal necessarily a hardware error. - Restart the analyzer.
- Contact Radiometer
service representative.
Removal conditioning:
- Successful Blank
calibration

1012 Oxi has no The system has not made a - Repeat the
sample spectrum sample measurement yet, or measurement.
there is a hardware problem. - Restart the analyzer.
- Contact Radiometer
service representative.

1013 Oxi data Oxi hardware error - Restart the analyzer.

collection error - Perform a calibration.
- Contact Radiometer
service representative.

10-23
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

1014 Oxi Blank Cal. The spectrometer received - Check solution pack.
intensity too high too high light intensity during During Oxi Blank
Blank Cal. calibration, the cuvette
must be filled with
liquid.
- Perform a calibration.
- Restart the analyzer.
- Contact Radiometer
service representative.

1015 Oxi sample The spectrometer received - Check solution pack.

intensity too high too high light intensity during During Oxi Blank
sample measurement. calibration, the cuvette
must be filled with
liquid.
- Perform a calibration.
- Repeat the sample
measurement.

1016 Oxi Blank Cal. The spectrometer received - Perform a calibration.

intensity too low too low light intensity during - Restart the analyzer.
Blank Cal. - Contact Radiometer
service representative.

1017 Oxi sample The spectrometer received - Restart the analyzer.

intensity too low too low light intensity during - Perform a calibration.
sample measurement. - Contact Radiometer
service representative.

1018 Oxi electronic Oxi hardware problem. - Restart the analyzer.

adjustment error - Perform a calibration.
- Contact Radiometer
service representative.

1019 Oxi Blank Cal. Peak value of Blank Cal. - Check solution pack.
outside limits spectrum intensity is outside The cuvette must be
acceptance limits. filled with liquid during
Blank calibration.
- Perform a calibration.
- Restart the analyzer.
- Contact Radiometer
service representative.

1020 Oxi neon Oxi hardware problem. - Restart the analyzer.

intensity outside - Perform a calibration.
limits - Contact Radiometer
service representative.

1021 Oxi neon Oxi hardware problem. - Restart the analyzer.

correction - Contact Radiometer
outside limits service representative.

1022 Oxi background Oxi hardware problem. - Restart the analyzer.

correction - Contact Radiometer
outside limits service representative.

1023 Oxi spectrometer Oxi hardware problem. - Restart the analyzer.

memory read - Contact Radiometer
problem service representative.

10-24
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

1024 Oxi spectrometer Oxi hardware problem. - Restart the analyzer.

memory write - Contact Radiometer
problem service representative.

1025 Oxi hemolyzer Oxi hardware problem. - Restart the analyzer

tuning problem - Contact Radiometer
service representative.

1026 Oxi hemolyzer Oxi hardware problem. - Restart the analyzer.

frequency - Contact Radiometer
problem service representative.

1027 Oxi hemolyzer Oxi hardware problem. - Restart the analyzer.

temperature - Contact Radiometer
deviation too service representative.
high

1028 Oxi neon voltage Oxi hardware problem. - Restart the analyzer.
outside limits - Contact Radiometer
service representative.

1029 Oxi light source Oxi hardware problem. - Restart the analyzer.
voltage outside - Contact Radiometer
limits service representative.

1030 Oxi hemolyzer Oxi hardware problem. - Restart the analyzer.

voltage outside - Contact Radiometer
limits service representative.

1031 Oxi initialization Oxi initialization in progress. - Please wait up to 50

in progress minutes before
restarting the analyzer.
- Restart the analyzer.
- Contact Radiometer
service representative.

1032 Oxi data Oxi hardware problem. - Restart the analyzer.

collection - Contact Radiometer
problem service representative.

1033 Oxi task was not Internal software problem. - Restart the analyzer.
finished - Contact Radiometer
service representative.

1034 Oxi hardware An Oxi hardware problem - Restart the analyzer.

problem has occurred. - Perform a calibration.
- Contact Radiometer
service representative.

1045 Unable to read Unable to read information - Reinstall the solution

consumable stored on either sensor pack and sensor
information cassette or solution pack. cassette.
- Restart the analyzer.
- Contact Radiometer
service representative.

1061 Pressure test The sample transport - The analyzer will

flow error through the analyzer is automatically enter
hindered. "User-intervention
required". Follow the
instructions shown on
the screen.

10-25
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

1062 Pressure test A leak has been found in the - The analyzer will
pressure error solution transport. automatically enter
"User-intervention
required". Follow the
instructions shown on
the screen.

1063 Pressure test A leak has been found in the - The analyzer will
vacuum error solution transport. automatically enter
"User-intervention
required". Follow the
instructions shown on
the screen.

1064 Temperature in Hardware temperature error. - Ensure that the

sensor cassette ambient temperature is
top out of range between 15 and 32 °C.
- If the system has just
performed a cold start,
wait for the error to
disappear.
- Replace the fan filter,
if dirty.
- Shield the analyzer
from direct sunlight and
other heat sources.
- Contact Radiometer
service representative.

1065 Temperature in Hardware temperature error. - Ensure that the

sensor cassette ambient temperature is
bottom out of between 15 and 32 °C.
range - If the system has just
performed a cold start,
wait for the error to
disappear.
- Replace the fan filter,
if dirty.
- Shield the analyzer
from direct sunlight and
other heat sources.
- Contact Radiometer
service representative.

1066 Temperature in Hardware temperature error. - Ensure that the

sensor cassette ambient temperature is
substrate out of between 15 and 32 °C.
range - If the system has just
performed a cold start,
wait for the error to
disappear.
- Replace the fan filter,
if dirty.
- Shield the analyzer
from direct sunlight and
other heat sources.
- Contact Radiometer
service representative.

10-26
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

1069 Temperature in Hardware temperature error. - Ensure that the

Oxi cuvette out ambient temperature is
of range between 15 and 32 °C.
- If the system has just
performed a cold start,
wait for the error to
disappear.
- Replace the fan filter,
if dirty.
- Shield the analyzer
from direct sunlight and
other heat sources.
- Contact Radiometer
service representative.

1070 Sensor response Unstable signal from sensor. - Repeat measurement

error

1071 Temperature in Hardware temperature error. - Ensure that the

Oxi spectrometer ambient temperature is
out of range between 15 and 32 °C.
- If the system has just
performed a cold start,
wait for the error to
disappear.
- Replace the fan filter,
if dirty.
- Shield the analyzer
from direct sunlight and
other heat sources.
- Contact Radiometer
service representative.

1079 Sensor Sensor impedance error - Perform calibration

impedance error - Replace sensor
cassette

1081 Inhomogeneous Shown in the Activity Log - The analyzer will

rinse solution when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1083 Inhomogeneous Shown in the Activity Log - The analyzer will

cal 2 solution when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1084 Inhomogeneous Shown in the Activity Log - The analyzer will

cal 3 solution when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1085 Inhomogeneous Bubbles were detected in the - Perform a refill from

QC1 solution QC1 solution. the auxiliary program.
- Replace the solution
pack.

10-27
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

1086 Inhomogeneous Bubbles were detected in the - Perform a refill from

QC2 solution QC2 solution. the auxiliary program.
- Replace the solution
pack.

1087 Inhomogeneous Bubbles were detected in the - Perform a refill from

QC3 solution QC3 solution. the auxiliary program.
- Replace the solution
pack.

1089 Inhomogeneous Shown in the Activity Log - The analyzer will

gas when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1090 No rinse solution Shown in the Activity Log - The analyzer will
when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1092 No cal 2 solution Shown in the Activity Log - The analyzer will
when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1093 No cal 3 solution Shown in the Activity Log - The analyzer will
when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1094 No QC1 solution Shown in the Activity Log - The analyzer will
when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1095 No QC2 solution Shown in the Activity Log - The analyzer will
when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1096 No QC3 solution Shown in the Activity Log - The analyzer will
when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

10-28
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

1098 No gas Shown in the Activity Log - The analyzer will

when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1099 Pump calibration Shown in the Activity Log - The analyzer will
error when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1100 Outlet LS not Shown in the Activity Log - The analyzer will
empty during when "User-intervention automatically enter
pump calibration required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1101 Outlet LS not full Shown in the Activity Log - The analyzer will
during pump when "User-intervention automatically enter
calibration required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1111 Inhomogeneous Shown in the Activity Log - The analyzer will

air when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1112 LS inlet not Shown in the Activity Log - The analyzer will
empty when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1113 LS sensors not Shown in the Activity Log - The analyzer will
empty when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1114 LS outlet not Shown in the Activity Log - The analyzer will
empty when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1115 Ws Internal communication - Restart the analyzer.

communication error. - Contact Radiometer
error: wrong service representative.
message format

10-29
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

1116 Ws Internal communication - Restart the analyzer.

communication error. - Contact Radiometer
error: keep alive service representative.
timeout

1117 Oxi spectrometer A large deviation in - Perform a calibration

temperature drift temperature has been
observed. This is probably
due to a change in the
ambient environment.

1120 Sensor This message is shown in the - No action required. For

replacement Activity Log following a information only.
successful successful replacement of
the sensor cassette.

1121 The port did not This message is shown in the - Reinstall the sensor
open during Activity Log after a failed cassette.
sensor sensor cassette replacement. - Restart the analyzer.
replacement - Contact Radiometer
service representative.

1123 The sensor chip This message is shown in the - Reinstall the sensor
data could not be Activity Log after a failed cassette.
read or written sensor cassette replacement. - Restart the analyzer.
during - Contact Radiometer
replacement service representative.

1124 An unregistered This message is shown in the - No action required. For

sensor was Activity Log after a sensor information only.
installed during cassette replacement that
replacement did not identify a previously
conditioned cassette.

1125 An unregistered This message is shown in the - No action required. For

and used sensor Activity Log after a sensor information only.
was installed cassette replacement. It
during informs that the sensor
replacement cassette installed is already
used and no information
exists about the conditioning
hereof.

1126 A registered This message is shown in the - No action required. For

sensor had been Activity Log after a sensor information only.
used before cassette replacement. It
installation informs that the sensor
cassette installed has been
used before.

1134 The chip This message is shown in the - Reinstall the solution
information for Activity Log after a failed pack.
the solution pack solution pack replacement. - Restart the analyzer.
cannot be read - Contact Radiometer
or written service representative.

1135 The solution pack This message is shown in the - Reinstall the solution
has been used Activity Log after a failed pack.
before solution pack replacement.

10-30
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

1140 The solution pack This message is shown in the - Reinstall the solution
has used the Activity Log after a failed pack.
maximum solution pack replacement.
number of
measurements at
installation

1142 The printer door Printer door open. - Ensure that the printer
is open. Printing paper is properly
not possible installed.
- Close the printer door.

1143 Internal printer is Printer hardware error. - Ensure that the printer
offline. Printing paper is properly
not possible installed.
- Close the printer door.

1144 Check that Printer hardware error. - Ensure that the printer
printer door is paper is properly
closed and that installed.
paper is present - Close the printer door.

1145 A printer error Printer hardware error. - Ensure that the printer
has occurred. paper is properly
Call service installed.
technician - Close the printer door.

1146 Printer paper This message is shown in the - No action required. For
replaced Activity Log after information only.
replacement of printer paper.

1147 Inlet opened Shown in the Activity Log - The analyzer will
during rinse when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1148 Inlet open during Shown in the Activity Log - The analyzer will
calibration when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1149 Inlet open during Shown in the Activity Log - The analyzer will
wet section when "User-intervention automatically enter
activity required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1150 Inlet closed This message is shown in the - No action required. For
without Activity Log when a information only.
aspirating measurement has been
sample cancelled due to inlet being
closed before aspiration
could be completed.

10-31
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

1151 Inlet not closed: This message is shown in the - No action required. For
no sample Activity Log when a information only.
aspirated measurement has been
cancelled due to inlet being
closed too late.

1152 The solution pack This message is shown in the - Repeat replacement
chip data could Activity Log when a operation.
not be read or replacement of the sensor
written during cassette or solution pack has
replacement failed. The reason was that it
was impossible to
communicate with the chip
on the consumable.

1157 No valid FTC System error. - Contact Radiometer

programs service representative.
detected

1160 The top The top thermistor is not - Restart the analyzer
thermistor is not connected - If still present, replace
connected top thermistor
1161 The top The top thermistor short- - Restart the analyzer
thermistor short- circuited - If still present, replace
circuited top thermistor
1163 The sensor The sensor cassette - Restart the analyzer
cassette thermistor is not connected - If still present, replace
thermistor is not sensor cassette
connected

1164 The sensor Sensor cassette thermistor is - Restart the analyzer

cassette short-circuited - If still present, replace
thermistor is sensor cassette
short-circuited

1165 Solution pack not Shown in the Activity Log - The analyzer will
properly installed when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1166 Solution pack Shown in the Activity Log - The analyzer will
expired when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1167 Sensor cassette Shown in the Activity Log - The analyzer will
not properly when "User-intervention automatically enter
installed required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

10-32
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

1168 Sensor cassette Shown in the Activity Log - The analyzer will
expired when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1169 Unable to pump Shown in the Activity Log - The analyzer will
solutions when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1170 Inlet has been Shown in the Activity Log - The analyzer will
open for too long when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1171 Inlet is missing Shown in the Activity Log - The analyzer will
or in unknown when "User-intervention automatically enter
state required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1172 Sensor cassette Shown in the Activity Log - The analyzer will
damaged when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1173 Solution pack Shown in the Activity Log - The analyzer will
damaged when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1174 Inlet opened Shown in the Activity Log - The analyzer will
while the when "User-intervention automatically enter
analyzer was required" has been entered "User-intervention
busy due to this reason. required". Follow the
instructions shown on
the screen.

10-33
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

1175 Sensor Hardware temperature error - Ensure that the

temperature (Thermistor). ambient temperature is
error between 15 and 32 °C.
- If the system has just
performed a cold start,
wait for the error to
disappear.
- Replace the fan filter,
if dirty.
- Shield the analyzer
from direct sunlight and
other heat sources.
- Contact Radiometer
service representative.

1176 A liquid sensor Shown in the Activity Log - The analyzer will
error was when "User-intervention automatically enter
detected required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1177 A flow selector Shown in the Activity Log - The analyzer will
error was when "User-intervention automatically enter
detected required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1178 A pump Shown on screen when - The analyzer will

calibration error "User-intervention required" automatically enter
was detected has been entered due to this "User-intervention
reason. required". Follow the
instructions shown on
the screen.

1180 An error occurred Shown in the Activity Log - The analyzer will
when trying to when "User-intervention automatically enter
communicate required" has been entered "User-intervention
with wet section due to this reason. required". Follow the
instructions shown on
the screen.

1181 A software or Shown in the Activity Log - The analyzer will

hardware error when "User-intervention automatically enter
exists in wet required" has been entered "User-intervention
section due to this reason. required". Follow the
instructions shown on
the screen.

1183 Valve Shown in the Activity Log - The analyzer will

malfunctioning when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

10-34
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

1184 Leak detected Shown in the Activity Log - The analyzer will
when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow 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 - Restart the analyzer

memory is critically low.
critically low

1187 Disk shows signs The permanent memory is - Contact Radiometer

of wear showing exhaustion signs service representative.
and should probably be
replaced soon.

1188 Disk shows The permanent memory is - Contact Radiometer

serious signs of showing exhaustion signs service representative.
wear and should be replaced soon.

1189 FTC aborted, LS Shown in the Activity Log - The analyzer will
state change when "User-intervention automatically enter
error required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1190 Inlet open Shown in the Activity Log - The analyzer will
when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1191 QA Portal Shown in the Activity Log - No action required. For

communication after enabling QA Portal information only.
enabled communication

1192 QA Portal Shown in the Activity Log - No action required. For

communication after disabling QA Portal information only.
disabled communication

1193 QA Portal output Shown in the Activity Log - No action required. For
queue cleared when the QA Portal has been information only.
reset.

1194 ABL not The analyzer is not - Contact your IT

connected to QA connected to the QA Portal. engineer.
Portal - Check QA Portal
Communication Setup,
including TCP/IP
address, port no. and
password.
- Check that QA Portal is
responding.
- Check network
connections.

10-35
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

1195 ABL not The analyzer was refused - Enter the correct
connected to QA connection to the QA Portal password in the
Portal - incorrect due to incorrect password. analyzer's QA Portal
password Communication Setup.

1196 ABL connected to The analyzer is connected to - No action required. For

QA Portal the QA Portal. information only.

1197 ABL disconnected The analyzer is disconnected - No action required. For

form QA Portal from the QA Portal. information only.

1198 ABL<>QA Portal Communication error - Contact IT engineer or

communication between the analyzer and Radiometer service
error - XML the QA Portal. representative.
packet could not
be parsed

1199 FTC program has This message is found in the - No action required. For
been retried Activity Log when a information only.
measurement or calibration
activity has been retried due
to error.

1200 Solution pack Shown in the Activity Log - The analyzer will
empty when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1201 Solution pack Shown in the Activity Log - The analyzer will
lifetime expired when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1202 Expiration date Shown in the Activity Log - The analyzer will
reached when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1203 Lifetime in Shown in the Activity Log - The analyzer will

analyzer when "User-intervention automatically enter
exceeded required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1204 No more Shown in the Activity Log - The analyzer will

activities left when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

10-36
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

1216 Lifetime in Shown in the Activity Log - The analyzer will

analyzer when "User-intervention automatically enter
exceeded required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1217 No more tests Shown in the Activity Log - The analyzer will
left when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1218 Expiration date Shown in the Activity Log - The analyzer will
reached when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1219 RiLiBÄK The measured value lies - No action required.

Violation: Value above the upper RiLiBÄK
above upper limit range.

1220 RiLiBÄK The measured value lies - No action required.

Violation: Value below the lower RiLiBÄK
below lower limit range.

1221 System Hardware temperature error - Ensure that the

temperature out (all). ambient temperature is
of range between 15 and 32 °C.
- If the system has just
performed a cold start,
wait for the error to
disappear.
- Replace the fan filter,
if dirty.
- Shield the analyzer
from direct sunlight and
other heat sources.
- Contact Radiometer
service representative.

1222 Temperature Hardware temperature error - Ensure that the

system error (Top/bottom thermistor). ambient temperature is
between 15 and 32 °C.
- If the system has just
performed a cold start,
wait for the error to
disappear.
- Replace the fan filter,
if dirty.
- Shield the analyzer
from direct sunlight and
other heat sources.
- Contact Radiometer
service representative.

10-37
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

1223 Analyzer did not The analyzer DMS has not - Restart the analyzer.
connect at start- been able to establish - Contact Radiometer
up contact to the WS(M) at service representative.
start-up.

1224 Analyzer is Shown in the Activity Log - No action required.

temporarily shut after temporary shutdown of
down the analyzer.

1225 The sample is The time between sampler - Either sampler draw
older than a day draw time and aspiration is time has been entered
larger than 1 day. incorrectly or time of
the analyzer is incorrect.
Change either to correct
the error.

1226 The sample age The time between sampler - Either sampler draw
is negative draw time and aspiration is time has been entered
less than zero. incorrectly or time of
the analyzer is incorrect.
Change either to correct
the error.

1227 Correction for Chloride is corrected for - No action required.

bicarbonate bicarbonate, calculated from
contains errors pH and pCO2. Errors from
from pH, pCO2 pH, pCO2 results in this error
on chloride.

1228 Correction for Lactate is corrected for ion - No action required.

lactate contains strength, calculated from K+,
errors from K+, Na+, Ca2+. Errors from K+,
Na+, Ca2+ Na+, Ca2+ results in this error
on lactate.

1230 Inlet gasket Shown in the activity log at - No action required.

replaced the time of a replacement.

1231 Inlet probe Shown in the activity log at - No action required.

replaced the time of a replacement.

1232 Inlet connection Shown in the activity log at - No action required.

gasket replaced the time of a replacement.

1233 Inlet cleaned Shown in the activity log at - No action required.

the time when an inlet
cleaning was performed.

1234 Demonstration
software - not for
clinical purposes

1235 Failed to aspirate Aspiration failed - Remove sampler.

sample Retry aspiration

1236 Failed to aspirate Aspiration failed, due to - Remove sampler.

sample blocked inlet Retry aspiration

1240 Liquid transport Unstable aspiration from - No action required

failed solution pack

1242 Liquid transport Unstable aspiration from - No action required

failed solution pack

10-38
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

1243 Liquid transport Unstable aspiration from - No action required

failed solution pack

1244 Liquid transport Unstable aspiration from - No action required

failed solution pack

1245 Liquid transport Unstable aspiration from - No action required

failed solution pack

1246 Liquid transport Unstable aspiration from - No action required

failed solution pack

1247 Liquid transport Unstable aspiration from - No action required

failed solution pack

1248 Liquid transport Unstable aspiration from - No action required

failed solution pack

1249 Liquid transport Unstable aspiration from No action required

failed solution pack

1250 Liquid transport Unstable aspiration from - No action required

failed solution pack

1253 Failed to aspirate Aspiration failed sample not - Retry aspiration

sample detected

1254 Failed to aspirate Aspiration failed sample not - Retry aspiration

sample detected

1257 Liquid transport Unstable aspiration from - No action required

failed solution pack

1258 Liquid transport Unstable aspiration from - No action required

failed solution pack

1259 Liquid transport Unstable aspiration from - No action required

failed solution pack

1260 Liquid transport Unstable aspiration from - No action required

failed solution pack

1261 Liquid transport Unstable aspiration from - No action required

failed solution pack

1262 Liquid transport Unstable aspiration from - No action required

failed solution pack

1263 Liquid transport Unstable aspiration from - No action required

failed solution pack

1264 Liquid transport Unstable aspiration from - No action required

failed solution pack

1265 Liquid transport Unstable aspiration from - No action required

failed solution pack

1266 Liquid transport Unstable aspiration from - No action required

failed solution pack

1267 Liquid transport Unstable aspiration from - No action required

failed solution pack

10-39
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

1268 Liquid transport Unstable aspiration from - No action required

failed solution pack

1269 Failed to aspirate Unstable aspiration from - No action required

sample solution pack

1270 Failed to aspirate Unstable aspiration from - No action required

sample solution pack

1271 Failed to aspirate Aspiration failed sample not - Retry aspiration

sample detected

1272 Failed to aspirate Aspiration failed sample not - Retry aspiration

sample detected

1275 Liquid transport Unstable aspiration from - No action required

failed solution pack

1276 Liquid transport Unstable aspiration from - No action required

failed solution pack

1279 Liquid transport Unstable aspiration from No action required No

failed solution pack action required

1280 Liquid transport Unstable aspiration from - No action required

failed solution pack

1281 Liquid transport Unstable aspiration from - No action required

failed solution pack

1282 Liquid transport Unstable aspiration from - No action required

failed solution pack

1283 Liquid transport Unstable aspiration from - No action required

failed solution pack

1284 Liquid transport Unstable aspiration from - No action required

failed solution pack

1285 Liquid transport Unstable aspiration from - No action required

failed solution pack

1286 Liquid transport Unstable aspiration from - No action required

failed solution pack

1290 Liquid transport Unstable aspiration from - No action required

failed solution pack

1292 Liquid transport Unstable aspiration from - No action required

failed solution pack

1294 Liquid transport Unstable aspiration from - No action required

failed solution pack

1295 Activity has been This message is shown in the - No action required.
repeated due to activity log when an activity
the following is repeated automatically. It
reason: lists the error and parameter
id that was the cause of the
repeat.

1296 Printer out of The printer is out of paper. A - Insert a new paper roll
paper new paper roll must be
inserted

10-40
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

1297 Printer is offline The printer is offline due to - Check the power
either a bad or missing connection
power / USB connection - Check the USB
connection
- Contact Radiometer
service representative.

1298 Printer lid open The printer lid is open - Close the printer lid

1299 Rinse activity A rinse activity has been - No action required.

repeated: repeated. The following
entries in the log explain the
reason for the repeat.

1300 Calibration A calibration activity has - No action required.

activity been repeated. The following
repeated: entries in the log explain the
reason for the repeat.

1301 QC activity A QC activity has been - No action required.

repeated: repeated. The following
entries in the log explain the
reason for the repeat.

1302 Startup activity A startup activity has been - No action required.

repeated: repeated. The following
entries in the log explain the
reason for the repeat.

1303 Activity An activity has been - No action required.

repeated: repeated. The following
entries in the log explain the
reason for the repeat.

1304 Calibration A calibration activity has - No action required.

activity repeated been repeated. The following
entries in the log explain the
reason for the repeat.

1305 End of repeat This message indicates the - No action required.

reason list end of repeat reasons. See
errors 1299-1304.

1306 Solution pack Shown in the Activity Log - The analyzer will
manually when "User-intervention automatically enter
removed required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1307 Disk space less The disk space on the - Delete some archives
than fifteen analyzer is low. to free up space on the
percent drive.

1308 Disk space less The disk space on the - Free disk space. E.g.
than one percent analyzer is less than 1 % deleting some archives

1309 Unable to start

FTC activity -
FTC activity in
progress

10-41
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

1310 Response error Sensor (Metabolite) does not - Replace sensor

work properly

1311 The analyzer chip It's not possible to read or - Contact Radiometer
data could not be write data to the analyzer service representative.
read or written chip

1312 Export data logs The export data log - Make sure the selected
failed operation has failed. export path exists.
- Make sure enough
space is available.

1313 Export data logs The export data log - No action required.
done operation has completed
successfully.

1314 Sensor Sensor temperature error - Check sensor status

temperature (substrate) during rinse and replace, if
error during rinse necessary.

1315 Cal backlog error Cal backlog error (pH), - Perform rinse
(pH) leaping signals on rinse

1316 Cal backlog error Backlog unstable, leaping - Perform rinse

(pCO2) signals on rinse

1317 Cal backlog error Backlog unstable, leaping - Perform rinse

(pO2) signals on rinse

1318 Cal backlog error Backlog unstable, leaping - Perform rinse

(K) signals on rinse

1319 Cal backlog error Backlog unstable, leaping - Perform rinse

(Na) signals on rinse

1320 Cal backlog error Backlog unstable, leaping - Perform rinse

(Ca) signals on rinse

1321 Cal backlog error Backlog unstable, leaping - Perform rinse

(Cl) signals on rinse

1322 Cal backlog error Backlog unstable, leaping - Perform rinse

(Glu) signals on rinse

1323 Cal backlog error Backlog unstable, leaping - Perform rinse

(Lac) signals on rinse

1324 Inhomogeneous Shown in the Activity Log - The analyzer will

rinse solution (LS when "User-intervention automatically enter
sensors) required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1325 Sensor Show in activity log when a - Information only

thermistor recalibration of the sensor
recalibrated thermistor has been
performed

10-42
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

1326 Sensor Shown in the Activity Log - The analyzer will

thermistor when "User-intervention automatically enter
recalibration required" has been entered "User-intervention
failed - due to this reason. required". Follow the
thermistor mal- instructions shown on
functioning the screen.

1327 Analyzer locked User has locked the analyzer - No action required.
by user

1328 Analyzer locked The analyzer was locked on - No action required.

on request from request from LIS
LIS

1329 Analyzer locked The analyzer was locked on - No action required.

on request from request from Radiance
Radiance

1330 pO2 substrate The thickness of the pO2

thickness substrate is outside the
ranges

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 - No action required

replaced Activity log to indicate
replacement of solution pack

1336 Sensor cassette This message is used in the - No action required

replaced Activity log to indicate
replacement of sensor
cassette

1337 Printer paper This message is used in the - No action required

replaced Activity log to indicate
replacement of printer paper

1338 Demo mode This message is used in the - No action required

enabled Activity log to indicate that
ABL 90 demo mode has been
enabled

1339 Demo mode This message is used in the - No action required

disabled Activity log to indicate that
ABL 90 demo mode has been
disabled

1340 Sensor cassette This message is used in the - No action required

maintenance by Activity log to indicate
Analyzer has startup using a sensor
been interrupted cassette which has been left
without an FTC activity for
more than 2 hour.

10-43
10. Messages ABL90 FLEX reference manual

No. Message Interpretation Operator action

1341 Leak detected Shown in the Activity Log - The analyzer will
when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1342 Leak detected Shown in the Activity Log - The analyzer will
when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1343 Unable to pump Shown in the Activity Log - The analyzer will
solutions when "User-intervention automatically enter
required" has been entered "User-intervention
due to this reason. required". Follow the
instructions shown on
the screen.

1344 Solution pack This message is used in the - No action required

removed Activity log to indicate
replacement of solution pack

1345 Solution pack This message is used in the - No action required

inserted Activity log to indicate
replacement of solution pack

1346 Sensor cassette This message is used in the - No action required

removed Activity log to indicate
replacement of sensor
cassette

1347 Sensor cassette This message is used in the - No action required

inserted Activity log to indicate
replacement of sensor
cassette

1348 Warning - This message is used in the - Plug analyzer into

Battery low Activity log to indicate low mains
battery level

1349 Analyzer Analyzer shutdown due to - No action required

shutdown due to low battery
low battery

1350 Clot suspected in Clot suspected in inlet - No action required

Inlet

1351 Clot suspected in Clot suspected in sensor - No action required

sensor cassette cassette

1352 Clot suspected in Clot suspected in OXI module - No action required

OXI module

1353 User Action The analyzer has entered - User should perform
Needed entered User Action Needed action shown on screen

1354 User Action The analyzer has exited User - No action required
Needed exited Action Needed

10-44
ABL90 FLEX reference manual 10. Messages

No. Message Interpretation Operator action

1355 Conditioned Conditions for performing a - No action required

Sensor Startup conditioned sensor startup
was fulfilled.
The analyzer does not
initially perform calibration
with every measurement.

1356 Non-Conditioned Conditions for performing a - No action required

Sensor Startup conditioned sensor startup
was fulfilled.
The analyzer does not
initially perform calibration
with every measurement.

1357 Software This message is shown in the - No action required

upgrade initiated Activity log when a software
upgrade has been initiated

1358 Upgraded from This message is shown in the - No action required

Activity log when a software
upgrade has been performed

1359 Upgrade option: This message is shown in the - No action required

Activity log when a software
upgrade has been performed

1360 No clots detected This message is shown in the - No actions

in Analyzer Activity log when the clot
detection program did not
detect any clots

1361 Internal The reference electrode is - Replace sensor

reference malfunctioning cassette
electrode error in
sensor cassette

10-45
10. Messages ABL90 FLEX reference manual

10-46
 I Appendix - Quality control
General information ............................................................................. I-2
Statistical parameters .......................................................................... I-3
Control ranges (for manual QC only) ...................................................... I-4
User control ranges (for manual QC only) ............................................... I-6
Statistics factor and statistics range ....................................................... I-9
Temperature corrections (for manual QC only)....................................... I-10
Westgard rules.................................................................................. I-12
Quality control evaluation ................................................................... I-15
Appendix – Quality control ABL90 FLEX reference manual

General information

This appendix includes general information about quality control/quality

management that is relevant and in some case also specific for the ABL90 FLEX
analyzer.
Some of the sections in this appendix contain information about both built-in
and manual quality controls. Most of the information in this appendix is,
however, only relevant for manual quality control and the appendix is, therefore,
first and foremost thought as a supplement to the manual quality controls.

I-2
ABL90 FLEX reference manual Appendix – Quality control

Statistical parameters

This section describes the terms and statistical parameters used in the topic
quality control:

Parameter Definition
Mean value, X The mean value is the average value as shown below:

X
X
n
where
X = single result

X = the sum of single results

n = number of single results

Standard The standard deviation describes the distribution about

Deviation, SD the mean value and is calculated as follows:

1 SD 
 (X  X) 2

n 1
and can be illustrated on the normal distribution curve:

1 SD includes 68.3 % of the results.

2 SD includes 95.5 % of the results and is normally
used for clinical instruments.
Coefficient of Coefficient of variation expresses the variation in the
variation, CV% sampling results and is calculated as follows:
SD
CV   100 (%)
X
where SD = standard deviation and X = mean value
from lot-to-date.
CV% is used to compare the deviation from the
absolute mean value from lot-to-date and can,
therefore, be of limited use at low mean values with low
precision.

I-3
Appendix – Quality control ABL90 FLEX reference manual

Control ranges (for manual QC only)

About control The control ranges are the ranges within which the result of a quality control
ranges measurement should fall in order for the analyzer to be well functioning. Each
package of quality control ampoules is supplied with an insert with control ranges
for all parameters and analyzers which the given quality control system can
evaluate.
As the control ranges determine whether an analyzer is judged to be well
functioning or not, it is imperative that they are founded on well-established
reference methods and certified reference standards, and in-depth knowledge of
the correlation between an analyzer type and the quality control solution.
Blood gas analyzers are developed to analyze whole human blood, and different
types of analyzers will measure identical values (within the specifications). The
blood algorithm of the analyzers ensures this. When quality control solutions,
which are not blood, are measured, the same corrections will be applied to the
quality control result. Therefore, different types of analyzers will measure
differently, and control ranges must be established separately for each type of
analyzer.
The width of the control ranges is determined during the development phase by
measuring on a number of analyzers. The measurements are performed by
different persons, over several days, using different dispensers and with different
lot numbers of calibration solutions – all this to ensure that all natural variations
such as:

 person-to-person  day-to-day
 analyzer-to-analyzer  dispenser-to-dispenser
 lot-to-lot  variation from calibration solutions, etc.

are included in the control ranges.

Definitions The following terms are used by Radiometer in connection with control ranges:

Term Explanation At Radiometer

True value The value of a The true value for each parameter
parameter in a quality included in the reference ampoules
control solution, e.g. are determined by the Metrology
pH, is traceable to a Section at Radiometer Medical using
primary reference NIST standards or standards
standard. traceable to the Danish primary
laboratory for Electrochemistry
There is one true value
(DPLEC) at the Danish Institute of
for each parameter per
Fundamental Metrology (DFM). This
lot of a quality control
primary laboratory is accredited by
solution.
Danish Accreditation.
The true value of a
parameter is analyzer-
independent.

I-4
ABL90 FLEX reference manual Appendix – Quality control

Term Explanation At Radiometer

Assigned value The center value of a When a quality control system is
control range. developed, it is tested on 10 well-
functioning analyzers of the type for
There is one assigned
which the quality control system
value for each
has been designed. Measurements
parameter for each
on level 1 – level 2 – level 3 – level
type of analyzer.
4 are performed two to five times
during 24 hours. These
measurements are repeated for 1–
4 weeks in order to give 30 – 50
measurements per analyzer.
From true The true value of a parameter is
value to correlated to the assigned value by
assigned value an algorithm for a particular type of
analyzer and QC product. This is a
one-time-only act.
Insert control The interval within The insert control ranges are
ranges which a quality control established by being centered
result of a well- around each parameter's assigned
functioning analyzer value.
should fall with at least
The width of the insert control
95 % probability.
ranges is determined using an
uncertainty budget comprising
contributions from the analyzer, the
calibration solutions and the QCs.
The uncertainty budget guarantees
that only relevant contributions to
the width of the insert control
ranges are included.
User control A range established by
ranges the user based on
(analyzer- results obtained on
specific) one analyzer.

The inserts have control ranges for all analyzers for which the quality control
solution can be used. By using the data codes on the inserts, the information
about the type and level of the quality control solution and control ranges for all
parameters are transferred to the analyzer. The analyzer is then able to
recognize the quality control solutions.

I-5
Appendix – Quality control ABL90 FLEX reference manual

User control ranges (for manual QC only)

Introduction The specified control ranges in the inserts, which are established by Radiometer,
include all well-functioning analyzers, and the uncertainty budget will therefore
include a contribution derived from the analyzer-to-analyzer variation. This
means that results obtained on one specific analyzer should fall within control
ranges that are narrower than the insert control ranges.
Before establishing analyzer-specific or so-called user-defined control ranges,
you should ensure that your analyzer functions correctly and is properly
maintained. The procedure below should be followed. User control ranges must
be established and updated each time you start using a new lot of quality
control solutions.

Establishing Perform 20 measurements on each level of quality control solution in order to

analyzer- take into account the following variations:
specific control
 sample-to-sample
ranges
 person-to-person by using two or more people to make measurements
 day-to-day by spreading measurements over a minimum of 4-5 days
 other variations such as uncertainty from calibration solutions, chemical
decomposition of the quality control solutions, and inhomogeneity of the QC
lot should be included in the user-defined control ranges (see procedure
further in this chapter).

The following requirements should be fulfilled for analyzer-specific control

ranges:
 The established mean value falls within the insert control ranges
 Worldwide DATACHECK participants: the established SD is not wider than
1.26 x Avg(SD) of the peer group of similar analyzers

To establish your own control ranges, do the following.

Step Action
1. Perform at least 20 measurements as described above.
2. Enter the QC screen (press Menu > Utilities > Setup (if
necessary, log on) > QC Setup > QC Ranges).
Select the desired control solution by pressing Next Slot.
3. Press Edit to change the lower/upper limit in the "Lot to date range
(2SD)" column. Confirm each change with Enter on the keypad.
Use Next or Prev. Param. to change to another parameter.
4. Press Close to exit the program.

To get full benefit from the evaluation procedure, Radiometer recommends the
use of a statistics factor of 1.5 (default) to establish the statistics range (see
section Statistics factor and statistics range further in this appendix.
Another option is to manually correct the 2 SD control ranges in order to include
uncertainty contributions from:
 chemical decomposition of the QUALICHECK5+ solution
 inhomogeneity of QC lots
 calibration solutions

I-6
ABL90 FLEX reference manual Appendix – Quality control

To correct the 2 SD control ranges for the above contributions, do the following:

Step Action
1. Find the mean ( X ) and the two times standard deviation (2 SD)
value in the Quality Control log (press: Data Logs > Quality
Control Log > Statistics) or calculate the values from the last 20
quality control measurements.
2. Find SDtotal in tables below.
3. Determine SDcorrected as follows:

2  SD  2  SDtotal 
2 2
SDcorrected 

4. Determine the user-defined control ranges as X  SDcorrected .

5. Enter the user-defined control ranges for each parameter in the

Control Ranges setup program (press: Menu > Utilities > Setup
> QC Setup Control Ranges > Edit).

Table 1: SDtotal for QUALICHECK5+ solutions:

Level 1
Parameter: ABL90 FLEX analyzer
pH 0.0041
pCO2 kPa 0.14
pO2 kPa 0.31
cK+ mmol/L 0.035
+
cNa mmol/L 0.7
cCa2+ mmol/L 0.021

cCl mmol/L 1.26
cGlu mmol/L 0.1
cLac mmol/L 0.1
ctBil mol/L 2.5
ctHb g/dL 0.11
FHbF % 1
Other Hb derivatives % 0.13

Level 2
Parameter: ABL90 FLEX analyzer
pH 0.0054
pCO2 kPa 0.09
pO2 kPa 0.26
cK+ mmol/L 0.036
+
cNa mmol/L 0.6

I-7
Appendix – Quality control ABL90 FLEX reference manual

cCa2+ mmol/L 0.020


cCl mmol/L 1.16
cGlu mmol/L 0.1
cLac mmol/L 0.1
ctBil mol/L 3.0
ctHb g/dL 0.13
FHbF % 3.6
Other Hb derivatives % 0.36

Level 3
Parameter: ABL90 FLEX analyzer
pH 0.0074
pCO2 kPa 0.07
pO2 kPa 0.44
+
cK mmol/L 0.036
+
cNa mmol/L 0.6
cCa2+ mmol/L 0.019

cCl mmol/L 1.08
cGlu mmol/L 0.4
cLac mmol/L 0.2
ctBil mol/L 4.1
ctHb g/dL 0.18
FHbF % 2.6
Other Hb derivatives % 0.19

Level 4:
Parameter: ABL90 FLEX analyzer
pH 0.0046
pCO2 kPa 0.26
pO2 kPa 0.73
+
cK mmol/L 0.055
cNa+ mmol/L 0.5
2+
cCa mmol/L 0.023

cCl mmol/L 0.95
cGlu mmol/L 0.1
cLac mmol/L 0.1
ctBil mol/L 2.2

I-8
ABL90 FLEX reference manual Appendix – Quality control

ctHb g/dL 0.06

FHbF % 0.4
Other Hb derivatives % 0.1

Statistics factor and statistics range

Definitions Normal statistical variation implies that 95.5 % of all quality control results
obtained on a well-functioning analyzer falls within  2 SD range, and 99.7 %
falls within  3 SD range.
In order to include all results from a well-functioning analyzer, a statistics factor
of 1.5 (default) is used to expand the control ranges. This also ensures that user
control ranges do not become too narrow over time.
Using the recommended statistics factor of 1.5 will have the following effect:

User control ranges (2 SD): The statistics range will correspond toX  3 SD.
Insert control ranges: The statistics range will correspond to 1.5 
insert control range.

All results outside the statistics range will be excluded from the statistics and
marked accordingly.

Example The control range is: pH low = 6.986 and pH high = 7.016
To calculate the statistics range, do the following:

Step Action
1. Calculate the mean value: X = (6.986 + 7.016)/2 = 7.001.
2. Calculate the 2 SD: pH high  X = 7.016  7.001 = 0.015.
3. Calculate the 3 SD: (0.015 3)/2 = 0.0225 = 0.023.
4. The statistics range will then be:
pH low = 7.001  0.023 = 6.978.
pH high = 7.001 + 0.023 = 7.024.

I-9
Appendix – Quality control ABL90 FLEX reference manual

Temperature corrections (for manual QC only)

Purpose Temperature correction is done to ensure that the quality control results reflect
the analyzer performance and are not influenced by fluctuations in the ambient
temperature.

Parameters The insert control ranges are determined at a reference temperature of 25 °C.
that require Deviations from this temperature will have an impact on the following
temperature parameters: pH, pCO2 and pO2.
correction
The reason for temperature correction is as follows:

An unopened ampoule consists of two phases: a liquid and

a gas phase. Both phases contain molecules of CO2 and O2,
and equilibrium between the two phases is temperature
dependent. As only the liquid phase is measured, it is
important to temperature correct the result to the actual
temperature.

To ensure that the QC result actually reflects the performance of the analyzer and
not just fluctuates because of temperature variations, it is important to keep the
ampoule at a stable and known temperature, so that variations can be corrected
for in the correct way.

The default temperature of a QC measurement is automatically set at 25 C

unless otherwise specified by the user. If the ampoule temperature is not 25 C,
the equilibrium will be different. The lower the temperature, the more O2 and CO2
molecules will migrate to the liquid phase, and the pCO2 and pO2 will report too
high values, and the pH a too low value, if the results are not temperature
corrected. If the temperature is higher than 25C, the pCO2 and pO2 values will be
too low and the pH too high, if the results are not temperature corrected. The pH
value will be affected, as an increase of the pCO2 will make the quality control
solution more acidic.

Temperature Parameters
pH pCO2 pO2
> 25 C   
< 25 C   

where  = higher values, and  = lower values.

Radiometer recommends that ampoules that have been stored in a cool place are
conditioned at a known room temperature for at least 5 hours before a
measurement, and we strongly advise not to keep ampoules on the top of an
analyzer as the temperature there can vary.

In the ABL90 FLEX analyzers the software will automatically temperature correct
the results on Radiometer QUALICHECK5+ solutions once the ambient
temperature has been entered.
Radiometer uses a reference temperature of 25 C.

I-10
ABL90 FLEX reference manual Appendix – Quality control

Temperature Range+ QUALICHECK solutions (usable for e.g. Calibration verification, see
corrections for section Calibration verification in Chapter 6: Calibration in the ABL90 FLEX
pH, pCO2 and operator's manual).
pO2
Parameter Equation for temperature correction
pH: pH(corr. to 25 C) = pH(meas.)  A(t  25)

pCO2: pCO2(corr. to 25 C) = pCO2(meas.)  1  A(t  25) 

pO2: pO2(corr. to 25 C) = pO2(meas.)  1  A(t  25) 

where A = a temperature constant. The values are given in the table below.

Range+ QUALICHECK Temperature constants, A

Level 1 Level 2
pH 0.0013 0.0026
pCO2 0.0056 0.0071
pO2 0.0098 0.0107

NOTICE: Temperature fluctuations for S7950 (level 3) are negligible so that no

temperature corrections are required for this control solution.

I-11
Appendix – Quality control ABL90 FLEX reference manual

Westgard rules

About The Westgard rules are a set of statistical rules that, when applied to the quality
Westgard rules control results, can aid the following:

 Increase the probability of detecting an error on the analyzer by analyzing

the quality control measurements
 Help detecting a shift or trend in your quality control results by comparing
current measurement values of a control solution to previous values, thus
further enabling you to determine the quality and validity of your blood
sample results

Westgard rules are based on the calculation of the mean and standard deviation
(SD) of quality control measurement values for a particular parameter and a
specific device, through modification of control ranges. They are best expressed
in the form of plots.
Westgard rules are divided into two types:

Westgard rule types Explanation

Warning rules Indicate that the next measurement should be
treated with care as the previous measurement
was outside the established ranges. It is
recommended to perform a second
measurement on a new ampoule of the same
level.
Rule 12s is the only warning rule.
Rejection rules Indicate an error and require troubleshooting
your analyzer before analyzing blood samples.
Rules 13s, 22s, R4s, 41s and 10x are rejection
rules.

Plot lines The following lines are used in the plots:

Shows 3 SD ranges
Shows control ranges (2 SD)
Shows the mean value

The Westgard rules described in the following are selected for evaluation of
quality control measurement results. All six rules are applicable to manual QC.
Only four of the rules are applicable to built-in QC.

I-12
ABL90 FLEX reference manual Appendix – Quality control

Rule 12s This rule is a warning rule.

Measurement value is
outside the mean  2 SD.

Corrective action: Perform another measurement on a new ampoule

of the same level. If the second result falls within
the control range, then the first result can be
attributed to normal statistical variation.
If the second result is outside the established
mean 2 SD, see section Quality control
evaluation further in this appendix.
This rule is applicable to both manual and built-in QC.

Rule 13s This rule is a rejection rule.

Measurement value is
outside the mean  3 SD.

Corrective action: Perform another measurement on a new ampoule

of the same level. If the second result falls within
the control range, then the first result can be
attributed to normal statistical variation.
If the second result is outside the established
mean 2 SD, see section Quality control
evaluation further in this appendix.
This rule is applicable to both manual and built-in QC.

Rule 22s This rule is a rejection rule.

Two consecutive
measurements are
outside the mean  2 SD
on the same side of the
mean.

Corrective action: Perform steps described in section Quality control

evaluation further in this appendix.
This rule is applicable to both manual and built-in QC.

I-13
Appendix – Quality control ABL90 FLEX reference manual

Rule R4s This rule is a rejection rule.

The difference between

two consecutive
measurements exceeds 4
SD.

This indicates inconsistency in your procedures or

an unstable analyzer.
Corrective action: Perform steps described in section Quality control
evaluation further in this appendix.
This rule is applicable to both manual and built-in QC.

41s This rule is a rejection rule.

Four consecutive
measurements outside
the mean 1 SD on the
same side of the mean.

This indicates a trend or shift.

Corrective action: Perform steps described in section Quality control
evaluation further in this appendix.
This rule is only applicable to manual QC and is only recommended when
user-defined control ranges are established.

Rule 10x This rule is a rejection rule.

10 consecutive
measurements on the
same side of the mean.

This indicates a trend or shift.

Corrective action: Perform steps described in section Quality control
evaluation further in this appendix.
This rule is only applicable to manual QC and is only recommended when
user-defined control ranges are established.

I-14
ABL90 FLEX reference manual Appendix – Quality control

Quality control evaluation

Evaluation The QC evaluation procedure for analyzers is as follows:

procedure
 Check if the QC results are marked with a "?" (a "?" can be caused by an error
in the previous calibration or by analyzer malfunctions). In case of "?", follow
the troubleshooting instructions on the screen.
 Check the presence of any other markings in the QC result. In case of any
markings, follow the troubleshooting instructions on the screen, and, if
running manual QC, consider the questions below.

No. Question
1. Did you store the ampoules according to specifications?
2. Did you condition the ampoules according to the specifications?
3. Did you key in the correct ampoule conditioning temperature?
4. Did you shake the ampoule vigorously for 15 seconds before using
it?
5. Did you remember to hold the ampoule between your thumb and
index finger when you shook it? (This is done to avoid heating up
the ampoule contents and thus change its temperature.)
6. Did you analyze control solutions immediately after opening the
ampoule?
(Each QC ampoule must be used immediately after being opened,
for one measurement on one analyzer only, in order to ensure the
reliability of the measurement).
7. Did you use Radiometer QUALICHECK adapter?
8. If own user-defined limits were entered: Did you enter too narrow
control ranges?
9. If everything is OK – repeat the QC measurement.

I-15
Appendix – Quality control ABL90 FLEX reference manual

I-16
 II Appendix -
Traceability to the primary standards at
Radiometer
Appendix – Traceability to the primary standards at Radiometer ABL90 FLEX reference manual

Introduction
The Metrology Section at Radiometer is responsible for establishing metrological
traceability for the parameters pH, pCO2, pO2, cK+, cNa+, cCa2+, cCl–, cGlu,
cLac, sO2, FCOHb, FMetHb, FHbF, Hct, ctBil and ctHb. This booklet documents
the traceability for each of these parameters.

II-2
ABL90 FLEX reference manual Appendix – Traceability to the primary standards at Radiometer

Traceability
pH 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 accordance with the method recommended by the
International Union of Pure and Applied Chemistry (IUPAC). The Hydrogen
Electrode System of DLPEC is validated by comparison 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 Ref. 1.
The NIST SRMs used are: 186I/II, 185, 187, 191-192.
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 arrangement.

pCO2 and pO2 The primary gases used are Standard Reference Materials (SRMs) produced by
NIST. The NIST SRMs used are: 1674b, 2625a, 2658a and 2659a. The NIST
SRM gases are used to validate primary gravimetric working gas standards,
certified by Scott Medical, Air Liquide or Air Products. The primary gravimetric
working gas standards are validated using a computer-controlled gas
chromatography 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
chromatography 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+ The primary working standards used are gravimetric standards produced from
KCl and NaCl Suprapur, produced by Merck. These primary working standards
are validated using Standard Reference Materials (SRMs) produced by NIST, so
that traceability to NIST is achieved. The NIST SRMs used are: 919a (NaCl) and
999 (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 Ref. 2.
The primary working standards are used to determine the sodium and
potassium concentrations of the secondary working standards. The
concentrations of the secondary working standards are measured using a flame
photometer. The determination of the sodium and potassium concentrations of
fluorocarbon-based secondary standards is done using ion-selective K and ion-
selective Na electrodes on the ABL735 analyzer. The determination takes place
using the primary working standards.

II-3
Appendix – Traceability to the primary standards at Radiometer ABL90 FLEX reference manual

cCa2+ The primary standards used are the so-called Ca2+ transfer standards, produced
from CaCO3 Urtitersubstanz®, produced by Merck. 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. Validation of the Ca2+ transfer standards is done using similar
standards produced from NIST SRM 915.
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– The primary working standards are gravimetric standards, prepared from KCl
Suprapur, produced by Merck. The primary working standards are validated by
making comparative titrations using similar standards prepared from NIST SRM
999 (KCl). The titrations 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 (TitraLab 900 from Radiometer Analytical, France).

cGlu The primary working standards are prepared from NIST SRM 917a (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 Ref. 3.

cLac 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 reaction produces dihydronicotinamide (NADH), which is measured at 339
nm. The method is described in Ref. 4.

ctHb The primary standard used is an oxygenated whole-blood sample. The ctHb
value of this sample is determined by the use of the HiCN reference method.
This method is described in Ref. 5. 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 (product no. 3061) produced
by J.T Baker, Holland.
The primary standard is used to calibrate the ABL735 reference instruments.

II-4
ABL90 FLEX reference manual Appendix – Traceability to the primary standards at Radiometer

Saturation – The primary working standard used is a whole-blood sample, with the ctHb
sO2 = 100 % value adjusted to between 13 and 15 g %. 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 – The primary working standard used is a whole-blood sample. The blood sample
sO2 = 0 % is centrifuged and the resultant blood concentrate is deoxygenated using Argon
and treated with a dithionite solution.
The primary working standard is used to calibrate the ABL735 reference
instruments.

FCOHb – The primary standards used are CO with atmospheric air mixtures, produced in
normal value 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 chromatography method. The gas sample, injected into the gas
chromatograph, is the headspace of a blood sample which 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 Ref. 6.
The measured blood sample is used as secondary standard and is used to
calibrate the ABL735 reference instruments.

FCOHb – The primary working standard used is a whole-blood sample. The blood sample
100 % is tonometered with 100 % CO, with a certified purity of 99.997 % CO. The
primary working standard is used to calibrate the ABL735 reference
instruments.

FMetHb The primary working standard is a whole-blood sample. The FMetHb is

determined using the KCN addition method according to Evelyn and Malloy (Ref.
7). This method is a spectrophotometric method, where the absorbance
measurements are done at 630 nm (local peak for MetHb) on two sets of
solutions, prepared from the whole-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 whole-blood
sample can be calculated.

FHbF The primary working standard is a whole-blood sample. The FHbF of this sample
is determined using the Cation Exchange HPLC reference method. The method is
described in [Ref. 9]. The method is performed by the Hæmatology Laboratory
at Herlev Hospital, Denmark.

Hct Reference method

Radiometer uses a reference method based on the packed-cell-volume
procedure described by the Clinical and Laboratory Standards Institute (Ref.
10). The packed-cell volume is the measure of the ratio of the volume occupied
by the red cells to the volume of whole blood in a sample of capillary or venous
blood. The ratio is measured after appropriate centrifugation.

II-5
Appendix – Traceability to the primary standards at Radiometer ABL90 FLEX reference manual

Radiometer measurements
The Hct measurement is based on conductivity measured in a sample and then
corrected for the presence of sodium ions. A Sigma 201 Micro hematocrit
centrifuge with RCF of 12620*g, which fulfills most of the CLSI requirements,
has been used for the test together with 75 mm Microhematocrit capillary tubes
with an inner diameter between 1.1 and 1.2 mm. The centrifugation time has
been 5 minutes.
The conductivity and sodium concentration has been measured on
approximately 1000 blood samples with a sodium concentration varying from 80
mmol/L to 180 mmol/L. Hct measurements have then been correlated to the Hct
measured by the reference method.

ctBil The primary working standard is a whole-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 Ref. 11. The
reference instrument is calibrated using four levels of NIST SRM916a
unconjugated bilirubin standard material.

II-6
ABL90 FLEX reference manual Appendix – Traceability to the primary standards at Radiometer

References
1. Measurement of pH. Definition, standards, and procedures. (IUPAC Recommendations
2002). Pure and Appl Chem 2002; 74, 11: 2169-2200.
2. Standardization of sodium and potassium ion selective electrode systems to the flame
photometric method. NCCLS (CLSI) Publication C29-A2. Villenova, Pa.: NCCLS, 2000.
3. NCCLS (CLSI) Publication RS1-A, Villenova, Pa.: NCCLS .
4. Bergmeyer HU. Methods of enzymatic analysis. 3rd ed. Deerfield Beach: Verlag
Chemie, 1984; 6: 582-88.
5. Reference methods for the quantitative determination of hemoglobin in blood samples.
NCCLS (CLSI) Publication H15-A3. Villenova, Pa.: NCCLS, 2000
6. Collison HA, Rodkey FL, O'Neal JD. Determination of carbon monoxide in blood by gas
chromatography. Clin Chem 1968; 14, 2: 162-71.
7. Evelyn KA, Malloy HT. Microdetermination of oxyhemoglobin, methemoglobin, and
sulfhemoglobin in a single sample of blood. J Biol Chem 1938; 126: 655-62.
8. Kristoffersen K. An improved method for the estimation of small quantities of alkali-
resistant hemoglobin in blood. Scand J Clin Lab Invest 1961; 13: 402.
9. Tan GB, Aw TC, Dunstan RA & Lee SH, Evaluation of high performance liquid
chromatography for routine estimation of haemoglobins A2 and F. Journal of Clinical
Pathology 46: 852-856.
10. Procedure for determining packed cell volume by microhematocrit method. 2nd ed.
Approved standard. NCCLS (CLSI) Publication H7-A3. Villenova, Pa.: NCCLS, 2000.
11. Wahlfeld AW et al. Bile pigments: Technical aspects, modification of Malloy-Evelyn
method for a simple reliable determination of total bilirubin in serum. Scand J Clin Lab
Invest 1972; 29, Suppl 126: Hitachi Abstr. 11.12.

II-7
Appendix – Traceability to the primary standards at Radiometer ABL90 FLEX reference manual

II-8
 Index

Absorbance..............................................5-41 pH sensor ............................................ 5-20

total......................................................5-41 pH, cK+, cNa+, cCa2+, cCl– calibration .. 3-7
Access profiles ..........................................1-8 pO2 calibration ...................................... 3-7
Acoustic signal setup...............................1-49 pO2 sensor ........................................... 5-30
Activity vs concentration...........................5-3 sensitivity .............................................. 5-7
Adding a Note .........................................1-46 status ..................................................... 5-7
Adding a user activity..............................1-37 Calibration schedule options ................... 1-22
Age group limits, setting .........................1-13 Calibration schedule setup
Amperometry ............................................5-3 editing ................................................. 1-22
Analysis setup .........................................1-10 options, available ................................ 1-22
age group limits ...................................1-13 Cassette/instrument ID.............................. 4-3
reference and critical limits, setting .....1-14 Certificate of traceability........................... 9-5
sample type selection...........................1-12 Coefficient of variation (CV) .................... 7-5
selecting parameter profile ..................1-11 Communication of electronics .................. 4-2
selecting sex ........................................1-12 Communications setup............................ 1-52
Syringe modes .....................................1-10 Concentration vs activity .......................... 5-3
Analyzer identification ............................1-47 Conditions and corrective actions ........... 1-65
Analyzer messages ..................................10-2 Confidence intervals ................................. 7-5
Analyzer security.......................................1-4 Construction
access profiles........................................1-8 metabolite sensors ............................... 5-33
general security......................................1-4 optical system...................................... 5-39
operators and password .........................1-5 pCO2 sensor ........................................ 5-23
Analyzer settings .....................................1-47 pH and electrolyte sensors .................. 5-17
acoustic signal .....................................1-49 reference electrode .............................. 5-15
analyzer identification .........................1-47 Contents of setup settings ....................... 1-80
barometer setup ...................................1-50 Continuous spectrum............................... 5-41
languages.............................................1-51 Control ranges
time and date setup ..............................1-48 definitions ..............................................I-4
Anticoagulants (sampling).......................7-28 Conversion
Archives activity to concentration........................ 5-3
deleting ..................................................2-8 Conversion units ..................................... 8-42
export.....................................................2-8 Corrections
import ....................................................2-8 pCO2 sensor ........................................ 5-28
Automatic archiving ................................1-60 pO2 sensor ........................................... 5-31
Automatic archiving setup.......................1-60 user-defined .......................................... 6-1
Automatic backup setup ..........................1-62 Corrective actions ................................... 1-65
Automatic data request setup...................1-57 Corrrection factors
Automatic data transmission ...................1-55 electrolyte and metabolite parameters... 6-8
Automatic printing ..................................1-64 oximetry parameters and bilirubin ........ 6-5
Backing up all data ....................................2-4 pH and blood gases ............................... 6-4
Barcode reader, electronics........................4-4 CPU unit ................................................... 4-4
Barometer setup.......................................1-50 Creating a WDC report ............................. 2-3
Bias............................................................7-3 Critical limits .......................................... 1-12
Bilirubin ..................................................5-47 ctHb and derivates................................... 5-39
Bilirubin corrections................................5-49 Cuvette path length ................................. 5-44
Blood sample Data backup .............................................. 2-4
measuring process .................................3-5 Data logs export ........................................ 2-7
Built-in QC Data request setup ................................... 1-57
symbols in QC schedule ......................1-24 Data restoring............................................ 2-6
Calibration......................................... 3-7, 5-4 Data transmission (automatic)................. 1-55
calibration equation ...............................5-6 Deep Picture, The...................................... 8-2
calibration line.......................................5-6 Default layout selections......................... 1-12
Calibration schedule setup...................1-22 Default settings
general information ...............................5-5 acoustic signals ................................... 1-76
metabolite sensors ...............................5-34 analysis setup ...................................... 1-71
optical system ......................................5-44 automatic archiving............................. 1-77
Oxi calibration.......................................3-7 automatic backup ................................ 1-78
pCO2 sensor.........................................5-26 automatic printing ............................... 1-77
pCO2, cGlu, cLac calibration.................3-7 calibration schedule............................. 1-72
 communications setup .........................1-78 Exporting archives .................................... 2-8
corrective actions.................................1-76 Exporting data logs ................................... 2-7
general setup........................................1-74 General measuring principles.................... 5-3
language ..............................................1-76 General Security........................................ 1-4
miscellaneous setup .............................1-77 HbF
parameter setup....................................1-74 correction option ................................. 1-68
printer setup.........................................1-77 detection.............................................. 5-45
quality control setup ............................1-72 Importing archives .................................... 2-8
Radiometer default setup .....................1-70 Inlet
replacement setup ................................1-74 Electronics ............................................ 4-3
setup ....................................................1-70 Inlet positioning ........................................ 4-3
units .....................................................1-75 Input parameters...................................... 8-13
user-defined notes................................1-76 Interfacing facilities ................................ 1-83
user-defined patient data items ............1-75 barcode reader..................................... 1-84
Default values..........................................8-44 keyboard.............................................. 1-83
Defintion of terms .....................................7-3 mouse .................................................. 1-83
Deleting a Note........................................1-46 network ............................................... 1-83
Deleting a user activity ............................1-38 Interference
Deleting an archive....................................2-8 correcting for....................................... 5-45
Derived parameters.......................... 8-4, 8-15 Interference tests
acid-base..............................................8-15 metabolites .......................................... 7-23
numerical format .................................8-19 Lambert-Beer's law ................................. 5-40
oximetry ..............................................8-16 Languages ............................................... 1-51
oxygen .................................................8-16 LIS/HIS connection setup ....................... 1-53
units .....................................................8-19 List of equations...................................... 8-23
Detecting HbF .........................................5-45 Loading setup.......................................... 2-10
Determining concentrations.....................5-42 Lot............................................................. 9-2
Disabled versus deselected parameter .....1-11 Maintenance planning ............................. 1-39
Disk functions ...........................................2-1 Manual QC
Disk functions programs............................2-2 symbols in QC schedule...................... 1-24
Disk functions setup ................................1-60 Manual quality control (QC) solutions.... 1-23
Disk handling rules....................................2-2 Material safety data sheets ........................ 9-2
Disk storage (options)................................2-2 Matrix of constants ................................. 5-43
Display unit ...............................................4-4 Mean Corpuscular Hemoglobin
Editing Concentration
a user activity.......................................1-38 MCHC................................................. 7-26
a user-defined Note..............................1-46 Measured parameters .........................8-5, 8-6
parameter setup....................................1-42 Measurement............................................. 5-8
the QC schedule...................................1-26 metabolites .......................................... 5-35
user-defined patient data items ............1-44 pCO2 sensor ........................................ 5-27
Electrolyte parameters .............................8-19 pH sensor ............................................ 5-21
Electrolyte sensors pO2 sensor ........................................... 5-31
construction .........................................5-31 Measurements and corrections ................ 5-47
measurement........................................5-21 bilirubin............................................... 5-47
Electronic boards and components ............4-3 ctBil..................................................... 5-49
Electronics.................................................4-1 electrolytes .......................................... 5-21
barcode Reader ......................................4-4 oximetry parameters............................ 5-47
cassette and instrument ID.....................4-3 restrictions........................................... 5-48
communication ......................................4-2 Measuring principles
Components...........................................4-3 general................................................... 5-3
CPU Unit ...............................................4-4 metabolite sensors ............................... 5-36
display Unit ...........................................4-4 pCO2 sensor ........................................ 5-24
electronic boards....................................4-3 pH and electrolyte sensors .................. 5-18
general information ...............................4-2 pO2 sensor ........................................... 5-29
inlet........................................................4-3 Measuring processes ................................. 3-4
oximetry System....................................4-3 Menu
power supply .........................................4-3 setup...................................................... 1-3
printer unit .............................................4-4 Messages................................................. 10-1
sample mixer .........................................4-4 Metabolite sensors .................................. 5-32
sensor Interface......................................4-3 calibration ........................................... 5-34
sensor module........................................4-3 construction......................................... 5-33
user interface module ............................4-3 measurement ....................................... 5-35
wet section control.................................4-3 measuring principle............................. 5-36
Equation Miscellaneous setup ................................ 1-67
calibration..............................................5-6 activating an option............................. 1-68
Equation list.............................................8-23 analyzer messages ............................... 1-69
Evaluation - acceptance status ................. I-15 deactivating an option ......................... 1-68
 list of options .......................................1-67 measurement ....................................... 5-27
screen saver .........................................1-69 measuring principle............................. 5-24
selecting HbF correction option...........1-68 Performance test results – cCa2+ ............. 7-11
Notes (user-defined) ................................1-46 Performance test results – cCl–................ 7-10
ODC ........................................................8-37 Performance test results – cGlu............... 7-11
actual position......................................8-39 Performance test results – cK+ .................. 7-9
coordinates ..........................................8-41 Performance test results – cLac............... 7-12
determining actual displacement .........8-39 Performance test results – cNa+ .............. 7-10
displacement........................................8-38 Performance test results – ctHb............... 7-13
equations..............................................8-37 Performance test results – FCOHb.......... 7-15
reference position ................................8-37 Performance test results – FHbF............. 7-17
Operators and passwords ...........................1-5 Performance test results – FHHb ............ 7-17
Optical pO2 ................................................5-3 Performance test results – FMetHb......... 7-16
Optical system Performance test results – FO2Hb........... 7-15
calibration............................................5-44 Performance test results – pCO2................ 7-8
construction .........................................5-39 Performance Test Results - pH.................. 7-8
measured parameters ...........................5-39 Performance test results – pO2 .................. 7-9
measurement cycle ..............................5-40 Performance test results – sO2................. 7-14
Oximetry derived parameters ..................8-16 pH sensor
Oximetry parameters ...............................5-47 calibration ........................................... 5-20
Oximetry system construction......................................... 5-17
electronics..............................................4-3 measurement ....................................... 5-21
Oxygen derived parameters .....................8-16 measuring principle............................. 5-18
Oxygen release ..........................................8-2 pO2
Oxygen transport .......................................8-2 optical system...................................... 5-29
Oxygen uptake...........................................8-2 pO2 sensor
Oxyhemoglobin dissociation curve calibration ........................................... 5-30
(see also ODC) ....................................8-37 corrections........................................... 5-31
Parameter profile measurement ....................................... 5-31
selecting...............................................1-11 measuring principle............................. 5-29
Parameter setup .......................................1-41 measuring sequence ............................ 5-29
editing..................................................1-42 Potentiometry...................................5-3, 5-18
Parameter symbols ....................................8-3 Power supply............................................. 4-3
Parameters .................................................8-1 Print setup ............................................... 1-79
derived parameters....................... 8-4, 8-15 Printer unit ................................................ 4-4
units and numerical format ..............8-19 Printers.................................................... 1-63
disabled versus deselected ...................1-11 automatic printing ............................... 1-64
disabling ..............................................1-41 setup.................................................... 1-63
enabling ...............................................1-41 QA Portal connection setup .................... 1-59
general information ...............................8-2 QC
input parameters ..................................8-13 statistical parameters ..............................I-3
list of equations ...................................8-23 QC input setup ........................................ 1-28
locking.................................................1-42 QC ranges ............................................... 1-26
measured parameters ..................... 8-5, 8-6 updating .............................................. 1-28
The Deep Picture ...................................8-2 QC schedule
unlocking.............................................1-42 adding a new QC solution ................... 1-25
Parameters and input setup ......................1-41 editing the QC schedule ...................... 1-26
Password ...................................................1-5 QC statistics ............................................ 1-29
Patient data Quality control
user-defined items ...............................1-44 general information ................................I-2
Patient ID layout input setup........................................... 1-28
including a new item ...........................1-45 manual................................................. 1-23
Patient lookup setup ................................1-58 measuring process ................................. 3-9
Patient report setup ..................................1-16 QC schedule setup............................... 1-24
Patient reports ranges setup......................................... 1-26
default values.......................................1-18 statistical parameters ..............................I-3
layout creation .....................................1-16 statistics setup ..................................... 1-29
layout editing.......................................1-17 Quality control (automatic)
layout, patient ID .................................1-17 measuring process ................................. 3-8
patient ID layout ..................................1-17 Quality control (QC) solutions
patient result layout editing .................1-19 manual measurements ......................... 1-23
setup ....................................................1-16 Quality control schedule setup ................ 1-24
values, default......................................1-18 adding a new QC solution ................... 1-25
pCO2 sensor.............................................5-22 editing the QC schedule ...................... 1-26
calibration............................................5-26 Quality control setup............................... 1-23
construction .........................................5-23 Quality Management................................. 5-9
corrections ...........................................5-28 RADIANCE connection setup ................ 1-52
Radiometer default setup, access.............1-70 corrective actions ................................ 1-65
Recommended replacement intervals ......1-36 critical limits ....................................... 1-12
Reference electrode .................................5-13 default settings .................................... 1-70
background information ......................5-14 disk functions ...............................1-60, 2-1
construction .........................................5-15 general security ..................................... 1-4
Reference ranges and critical limits.........1-12 languages ............................................ 1-51
Replacement intervals .............................1-36 LIS/HIS connection setup ................... 1-53
Replacement schedule setup....................1-35 loading ................................................ 2-10
Replacement setup...................................1-35 maintenance planning ......................... 1-39
replacement intervals, recommended ..1-36 manual quality control (QC) solutions 1-23
user activities, adding ..........................1-37 miscellaneous...................................... 1-67
user activities, deleting ........................1-38 operators and password ......................... 1-5
user activities, editing ..........................1-38 parameters and input ........................... 1-41
Replacement warnings.............................1-40 patient lookup setup ............................ 1-58
Reportable ranges ....................................1-15 print setup ........................................... 1-79
Residual spectrum ...................................5-46 printer.................................................. 1-63
Restoring all data.......................................2-6 QA Portal connection setup ................ 1-59
Restoring default QC input.............................................. 1-28
Patient ID layout..................................1-45 QC ranges ........................................... 1-26
Restoring setup ........................................2-10 QC statistics ........................................ 1-29
RiLiBÄK ranges quality control ..................................... 1-23
activation/deactivation.........................1-32 RADIANCE connection...................... 1-52
adding ..................................................1-32 Radiometer default.............................. 1-70
editing..................................................1-32 reference ranges .................................. 1-12
removal................................................1-32 replacement ......................................... 1-35
Rinse process.............................................3-6 replacement schedule .......................... 1-35
Sample age evaluation setup....................1-21 replacement warnings ......................... 1-40
Sample counter ........................................1-85 reportable ranges ................................. 1-15
Sample pre-registration setup ..................1-20 RiLiBÄK ranges ................................. 1-32
Sample type selection ..............................1-12 sample age evaluation ......................... 1-21
Saving setup ..............................................2-9 sample pre-registration........................ 1-20
Screen saver syringe modes ..................................... 1-10
setting time ..........................................1-69 time and date ....................................... 1-48
Selecting a default layout ........................1-12 Units.................................................... 1-43
Selecting access to menus..........................1-8 user activities ...................................... 1-37
Selecting/deselecting Westgard Rules .....1-31 user-defined notes ............................... 1-46
Selector detector ........................................4-3 user-defined patient data items............ 1-44
Sensitivity...................... 5-7, 5-26, 5-30, 5-34 Westgard rules .................................... 1-30
Sensor cassette Setup menu
heating ...................................................3-4 structure ................................................ 1-3
Sensor interface .........................................4-3 Setup restoring ........................................ 2-10
Sensor Module, electronics........................4-3 Setup saving.............................................. 2-9
Sensor parameter limits ...........................5-12 Setup settings
Sensors ......................................................5-2 contents ............................................... 1-80
calibration..............................................5-5 general group ...................................... 1-81
construction ...........................................5-2 groups ................................................. 1-80
drift........................................................5-7 parameters group................................. 1-80
metabolites ..........................................5-32 schedules............................................. 1-82
pCO2 ....................................................5-22 Setups without Radiometer settings ........ 1-78
pH........................................................5-17 Sex selection ........................................... 1-12
pO2.......................................................5-28 SI units .................................................... 8-42
reference electrode...............................5-13 Solution expiration date ............................ 9-2
status......................................................5-7 Solution pack ............................................ 9-2
Setup..........................................................1-1 Solution pouch volume ............................. 9-3
acoustic setup ......................................1-49 Solutions ................................................... 9-1
analysis ................................................1-10 composition........................................... 9-3
analyzer identification .........................1-47 expiration date....................................... 9-2
analyzer security....................................1-4 general information ............................... 9-2
analyzer settings ..................................1-47 material safety data sheets..................... 9-2
automatic archiving setup....................1-60 pouch volume........................................ 9-3
automatic backup setup .......................1-62 solution pack ......................................... 9-2
automatic data request setup................1-57 use ......................................................... 9-3
automatic data transmission setup .......1-55 Spectrophotometry .................................... 5-3
automatic printing................................1-64 Spectrum examples ................................. 5-42
barometer.............................................1-50 spectrum repression ................................ 5-45
calibration schedule .............................1-22 Statistical parameters .................................I-3
communications...................................1-52 Statistics Factor and Statistics Range.........I-9
Status .......................................................5-30 User interface module
Storage.......................................................9-2 Electronics ............................................ 4-3
Symbols for manual and built-in QC.......1-24 User-defined corrections ........................... 6-1
Symbols, parameters..................................8-3 entering ................................................. 6-3
Syringe modes .........................................1-10 general information ............................... 6-2
System check.............................................5-9 slope and offset ..................................... 6-4
Temperature corrections User-defined notes .................................. 1-46
manual QC only................................... I-10 adding ................................................. 1-46
Test conditions ..........................................7-6 deleting................................................ 1-46
tHb calibration frequency ........................5-44 editing ................................................. 1-46
tHb corrections ........................................5-49 User-defined patient data items............... 1-44
The Deep Picture .......................................8-2 editing ................................................. 1-44
Time/date setup .......................................1-48 Values
To set up a new measuring mode: ...........1-11 default values ...................................... 8-44
Total absorbance......................................5-41 Waste removal .......................................... 3-4
Total analytical error .................................7-5 WDC
Traceability certificate...............................9-5 creating report ....................................... 2-3
Traceability of calibration solutions ..........5-5 Westgard rules ........................................ 1-30
Traceability to the primary standards at activating............................................. 1-31
Radiometer ........................................... II-1 rule R4s ...............................................I-14
Troubleshooting.......................................10-1 rule 10x ................................................I-14
Unit conversion .......................................8-42 rule 12s.................................................I-13
Units setup...............................................1-43 rule 13s.................................................I-13
Updating control ranges ..........................1-28 rule 22s.................................................I-13
User activities..........................................1-37 rule 41s.................................................I-14
adding ..................................................1-37 selecting/deselecting ........................... 1-31
deleting ................................................1-38 Wet section
editing..................................................1-38 contents ................................................. 3-2
User control ranges.................................... I-6 diagram ................................................. 3-3
Wet section control ................................... 4-3
ABL90 FLEX reference manual Date of issue

Date of issue

Radiometer representative: Manufacturer:

Radiometer Medical ApS

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2700 Brønshøj
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please contact your local www.radiometer.com
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ABL90 FLEX reference manual

- from software version 2.8xx

Publication: 201207
Edition: A
Code number: 995-433
Date of issue ABL90 FLEX reference manual