User Manual E

Thank you for purchasing

the BA200 biochemical
and turbidimetric
analyser
User manual

Manual version Revision date Changes

3.0 March 2018 Modified chapters: 4.12,
10.3.5, 18
Added chapter: 10.9.8,
10.9.9, 10.9.10
2.0 March 2017 Modified chapters 10.3.1.3,
10.4.3, 10.6.4,10.8, 10.12
Added chapter: 10.5.2
1.0 November 2016 Initial version

Manual code TEUS00055-03-ESP

All the necessary precautions have been taken to ensure that the information set
out in this manual is correct at the time of its publication. Nonetheless Biosystems,
S.A. reserves the right to make any changes that may be necessary without notice,
as an inseparable part of the product's ongoing development.
Any change made to the instrument by the client will render the warranty void
and without effect.

Manufacturer's address BioSystems, S.A.

C/ Costa Brava 30,
08030 Barcelona
SPAIN

http://www.biosystems.es

The BA200 analyser is compliant with EU directive 98/79/EC

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Table of contents
Staff for whom this manual is intended.............................................11
Notices and warnings........................................................................11
Software usage licence.......................................................................17
1. Intended use...............................................................................18
2. Contents.....................................................................................18
2.1. Content of the accessory box................................................................18
3. Identification of the main components.......................................21
4. Installation..................................................................................23
4.1. Location...............................................................................................23
4.2. Front door opening..............................................................................24
4.3. Installing the waste containers and washing solution...........................25
4.3.1. Preparing the washing solution..................................................................... 25
4.3.2. Emptying the high contamination waste container........................................ 26
4.4. Purified water connection....................................................................26
4.4.1. Positioning the tubes..................................................................................... 27
4.5. Low contamination waste connection..................................................28
4.6. Installing the sample and reagent rotor................................................28
4.7. Specifications of the barcode labels......................................................29
4.8. Affixing the identification labels...........................................................30
4.9. Installing the reaction rotor.................................................................31
4.10. Connection to the mains and start-up..................................................31
4.11. Connection to the computer................................................................33
4.12. Installing the user programme in the computer...................................33
4.12.1. Energy options configuration........................................................................ 36
4.12.2. Configure programmes in second plane........................................................ 37
4.12.2.1. Flash updates........................................................................................ 37
4.12.2.2. Java updates.......................................................................................... 38
4.12.2.3. Operating system services configuration................................................... 38
4.12.3. Cyberseurity configuration............................................................................ 39
4.12.3.1. Execution rights.................................................................................... 39
4.12.3.2. Configure the application user rights....................................................... 39
4.12.3.3. Activate and configure the operating system antivirus............................... 39
4.12.3.4. Run the antivirus before installing the application................................... 41
4.12.3.5. Do not install any extra program............................................................ 41
4.12.3.6. Update of windows versions................................................................... 42

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4.12.3.7. Verification of the integrity of the application.......................................... 44

4.12.3.8. Backup of the data................................................................................ 45
4.12.3.9. Recovery of the main password................................................................ 45
4.12.3.10. Connection to a host.............................................................................. 45
4.12.3.11. Use a VPN system.................................................................................. 47
4.13. ISE module installation (optional).......................................................47
4.14. First steps for operating the analyser....................................................50
4.15. Cautions during operation...................................................................51
4.16. Preanalysis and preparation of additional solutions.............................52
5. Transport and reshipment...........................................................54
6. Handling and storage..................................................................54
7. Operating principle....................................................................55
8. Description of the analyser.........................................................56
8.1. Cover and lids......................................................................................56
8.2. Sample and reagent rotor.....................................................................58
8.3. Reaction rotor......................................................................................59
8.4. Optical system . ...................................................................................59
8.5. Washing station....................................................................................60
8.6. Stirring arm..........................................................................................60
8.7. Dispensing arm....................................................................................61
8.8. Waste containers, purified water and washing solution........................62
8.9. ISE module (optional)..........................................................................63
9. Description of the software.........................................................65
9.1. Identification of the programme parts.................................................65
9.1.1. List of most frequently-used buttons............................................................. 65
9.1.2. List of fast access buttons.............................................................................. 66
9.1.3. List of buttons related to LIS communication............................................... 67
9.1.4. List of action buttons.................................................................................... 68
10. Working procedure.....................................................................69
10.1. Starting up the program.......................................................................69
10.2. Configuration......................................................................................70
10.2.1. General setup................................................................................................ 70
10.2.1.1. General configuration: work session......................................................... 70
10.2.1.2. General configuration: analyzer options.................................................. 71
10.2.1.3. General configuraion: Communications options....................................... 72
10.2.1.4. General configuration: Test Visibility....................................................... 73
10.2.2. Language...................................................................................................... 73
10.2.3. Reports......................................................................................................... 73

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 10.2.4. Arrangement of tests for report..................................................................... 74
10.2.5. Barcode......................................................................................................... 75
10.2.6. LIS configuration.......................................................................................... 76
10.2.6.1. Work session setup................................................................................. 76
10.2.6.2. Communication settings......................................................................... 77
10.2.6.3. Protocol................................................................................................ 78
10.2.7. LIS mapping................................................................................................. 79
10.2.8. Users............................................................................................................. 80
10.2.9. Change user.................................................................................................. 82
10.3. Programming.......................................................................................82
10.3.1. Tests.............................................................................................................. 82
10.3.1.1. Ordering of tests.................................................................................... 83
10.3.1.2. Test parameters: general......................................................................... 84
10.3.1.3. Test parameters: procedure...................................................................... 85
10.3.1.4. Test parameters: calibration and blank.................................................... 87
10.3.1.5. Test parameters: quality control.............................................................. 88
10.3.1.6. Test parameters: options......................................................................... 89
10.3.2. Calculated tests............................................................................................. 91
10.3.3. Contaminations............................................................................................ 93
10.3.4. Profiles.......................................................................................................... 94
10.3.5. Calibrators.................................................................................................... 95
10.3.6. Controls........................................................................................................ 97
10.3.7. Patient data................................................................................................... 99
10.3.8. ISE test....................................................................................................... 100
10.3.9. External test................................................................................................ 102
10.4. Initialising and switching off the analyser..........................................103
10.5. Work session......................................................................................104
10.5.1. Sample request............................................................................................ 104
10.5.2. Additional entering of patient information................................................. 109
10.5.3. Rotor positioning........................................................................................ 111
10.5.4. Creating the worklist from the sample positioning screen............................ 114
10.5.5. Worklist setup............................................................................................. 115
10.5.6. Save session................................................................................................. 116
10.5.7. Load session................................................................................................ 116
10.5.8. Delete session.............................................................................................. 117
10.5.9. Delete virtual rotors.................................................................................... 117
10.6. Current state monitor........................................................................117
10.6.1. Main........................................................................................................... 117
10.6.2. Worksession................................................................................................ 118
10.6.3. Sample and reagent..................................................................................... 120
10.6.4. Reactions.................................................................................................... 121
10.6.5. ISE module................................................................................................. 122
10.6.6. Alarms........................................................................................................ 123
10.7. Worksession results............................................................................124
10.7.1. Results by patient........................................................................................ 124
10.7.2. Results by test............................................................................................. 126
10.7.3. Reaction graphs.......................................................................................... 129
10.7.4. Result repetitions........................................................................................ 130

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User manual

10.8. Historical logs....................................................................................131

10.8.1. Patient results.............................................................................................. 131
10.8.2. Blank and calibrator results......................................................................... 133
10.8.3. Quality control results................................................................................. 134
10.8.4. Cumulative quality control results............................................................... 139
10.8.4.1. Accumulated daily quality control results.............................................. 139
10.8.4.2. Accumulated results............................................................................. 141
10.8.5. ISE Results.................................................................................................. 144
10.8.6. Historical analyzer alarm............................................................................. 145
10.9. Utilities..............................................................................................146
10.9.1. Change reaction rotor................................................................................. 146
10.9.2. Condition analyzer...................................................................................... 147
10.9.3. ISE utilities................................................................................................. 148
10.9.4. LIS utilities................................................................................................. 149
10.9.5. Create report SAT....................................................................................... 150
10.9.6. Create a restoration point with current data................................................ 151
10.9.7. Restore previous data.................................................................................. 152
10.9.7.1. Programming export............................................................................ 152
10.9.7.2. Programming Import........................................................................... 152
10.9.7.3. Audit trail.......................................................................................... 152
10.10. Help ..................................................................................................153
10.10.1. User manual................................................................................................ 153
10.10.2. Analyser information.................................................................................. 153
10.10.3. About.......................................................................................................... 153
10.11. Exit.....................................................................................................153
10.12. Automatic RestorePoint generation utility.........................................153
11. List of consumables and accessories..........................................154
12. Support and warranty...............................................................159
12.1. Warranty limits..................................................................................159
12.2. Technical assistance............................................................................159
13. List of alarms ...........................................................................160
14. Maintenance and cleaning........................................................167
14.1. Maintenance activities and frequency.................................................167
14.2. Cleaning the analyser.........................................................................168
14.2.1. General cleaning of compartments.............................................................. 168
14.2.2. Emptying and cleaning the high contamination waste bottle...................... 168
14.2.3. Cleaning the sample and reagent rotor........................................................ 168
14.2.4. Removing of condensation water from the reagent rotor............................. 168
14.2.5. Cleaning the barcode reader window........................................................... 169
14.2.6. Filling the washing solution bottle.............................................................. 169
14.2.7. Cleaning the stirrer paddle.......................................................................... 169
14.2.8. Cleaning the water inlet filters.................................................................... 169
14.2.9. Cleaning the ISE module............................................................................ 170

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 14.3. Maintenance.......................................................................................172
14.3.1. Changing the reaction rotor........................................................................ 172
14.3.2. ISE module maintenance............................................................................ 172
14.3.2.1. Changing the electrodes........................................................................ 172
14.3.2.2. Changing the reagent kit...................................................................... 175
14.3.2.3. Changing the peristaltic pump tubes..................................................... 176
14.3.2.4. Turning off the ISE module for a long period of time ............................ 178
14.3.2.5. ISE module reactivation...................................................................... 179
14.3.3. Maintenance frequency............................................................................... 180
14.3.4. End of the analyser's useful life................................................................... 180
15. Technical characteristics............................................................181
15.1. General characteristics.......................................................................181
15.2. Sample and reagent management.......................................................181
15.3. Reaction rotor....................................................................................182
15.4. Cuvette washing system......................................................................182
15.5. Optical system....................................................................................182
15.6. ISE module (optional)........................................................................182
15.7. Environmental requirements..............................................................183
15.8. Dimensions and weight......................................................................183
15.9. Electrical requirements.......................................................................183
15.10. Fluid requirements.............................................................................183
15.11. Minimum computer requirements.....................................................183
16. Measuring and calculation procedures......................................185
16.1. Operating sequence. Preparation and reading cycles..........................185
16.2. Calculation of the absorbances...........................................................186
16.2.1. Endpoint monoreagent............................................................................... 187
16.2.2. Endpoint bi-reagent.................................................................................... 188
16.2.3. Differential switch....................................................................................... 189
16.2.4. Fixed time monoreagent.............................................................................. 189
16.2.5. Fixed time bi-reagent.................................................................................. 190
16.2.6. Kinetic monoreagent................................................................................... 191
16.2.7. Kinetic bireagent......................................................................................... 192
16.3. Concentration calculation..................................................................193
16.4. Repetition criteria..............................................................................195
16.5. Calculation of the ISE ion concentration...........................................196
16.6. Internal Quality Control....................................................................198
16.6.1. Basis............................................................................................................ 198
16.6.2. Admissible value interval............................................................................. 198
16.6.3. Selection of control rules............................................................................. 199
17. Summary of workflow scenarios with the LIS...........................201

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User manual

17.1. Query by specimen and automatic start.............................................201

17.2. Query All...........................................................................................202
17.3. Sending results to the LIS. Upload.....................................................203
17.4. Repetitions.........................................................................................204
17.5. Reasons for rejection..........................................................................204
18. Menu tree..................................................................................206

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Staff for whom this manual is intended
This manual is intended for the use of clinical laboratory professionals who will
use the BA200 analyser to determine analyte concentrations.
This manual describes the characteristics and general operating concepts of the
BA200 analyser. The installation, programming, execution and maintenance
procedures are described in detail.

Notices and warnings

Explanation of the safety symbols located on the analyser or in this manual.

Symbol Description
The symbol warns of operating risks that could cause personal injury.

WARNING
The symbol warns of a potential biohazard.

BIOHAZARD
The symbol warns of potential damage to the system or unreliable results.

CAUTION
The symbol warns that the information requires your attention.

NOTE
Risk of electric shock

The symbol warns of a potential risk due to laser radiation emission

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User manual

Explanations of the symbols used on the analyser labels and in the manual

Symbol Description
This product is compliant with directive 98/79/EC on medical devices for In
Vitro Diagnostics.

Medical device for In Vitro Diagnostics

Please consult the directions for use

Serial number

Expiry date

Lot code

Catalogue number

Temperature limit

Manufacturer

Irritant

Date of installation

Distilled water

Caution, Possible biological and chemical spill

Caution, Exclusive use of Biosystems Washing Solution

Caution, Maximum weight 6 Kg

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 Symbol Description
Caution, Mechanical parts in motion, keep clear

Packaging label. Keep upright

Packaging label. Fragile

Packaging label. Keep dry

Packaging label. Keep vertical. Do not stack more than 200 Kg

Packaging label. Heavy equipment

Safety precautions

Symbol Description
Preventing electric shock
To reduce the risk of electric discharges, do not remove the analyser cover.
There are no parts inside that can be repaired by the user, for which reason it is
necessary to contact the technical assistance service.
Preventing biological risks in handling the samples
Inappropriate handling of samples, controls and calibrators could cause
biological infection. Do not touch the samples, mixtures or waste with your
BIOHAZARD hands. Wear gloves and protective clothing when necessary.
In the event that the samples come into contact with the skin, wash
immediately with abundant water and seek medical advice. It is advisable to
follow good laboratory practice.

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User manual

Symbol Description
Prevention in handling reagents
Handle reagents and washing solutions with care, they contain substances that
could be corrosive.
WARNING In the event that the reagents or washing solutions come into contact with the
skin, wash immediately with abundant water and seek medical advice.
Consult the reagent or washing solution adaptation sheet and follow the safety
instructions.
It is advisable to follow good laboratory practice.
Preventing biological risks in handling liquid waste
Handle the high contamination waste container with care. Wear gloves and
protective clothing when handling the container.
BIOHAZARD Dispose of the waste in accordance with national or local legislation for
disposing of dangerous biological waste, and consult the reagent manufacturer
or distributor for more details.
Preventing biological risks in handling solid waste
Take care in handling parts of the analyser that are converted to waste such as
the reaction rotor, sample tubes and reagent bottles.
BIOHAZARD Wear gloves and protective clothing when handling such waste.
Dispose of the waste in accordance with national or local legislation for
disposing of dangerous biological waste, and consult the reagent manufacturer
or distributor for more details.
Prevention of electro magnetic interferences
The analyser complies with the requirements with respect to emissions
and immunity set forth in the standard UNE -EN 61326-2-6:2006. This
NOTE equipment has been designed and tested for class B of standard UNE-EN
55022:2000. In a household environment, it may cause radio interference, in
which case the necessary measures must be taken to mitigate such interference.
Do not use the analyser near strong electro magnetic radiation sources (such
as centrifuge appliances, radio transmitters, mobile telephones), as they could
interfere with its correct operation.
Preventing laser light emission risks
The analyser has a bar code reader that emits laser light. The reader only works
when the analyser is in the execution mode and its rotor covers are in place. In
the event of a failure or during adjustment by technical maintenance staff, the
light beam could be activated without the cover in place; in such cases, do not
look directly at the laser beam.
Prevention at the end of the analyser's useful life
At the end of the useful life of the analyser, disposal of the product must be
carried out in accordance with the environmental legislation in force in each
country. In EU member states, the terms of the WEEE directive on electrical
and electronic appliances will apply. In other words, when the appliance's
useful life has ended, it is converted into waste and must be separated from
household waste for correct recycling. For this purpose, contact the distributor
for the product to be properly recycled.

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14
 Screenshots The screenshots shown in this manual have a merely illustrative function. They
do not necessarily reflect valid data.

Abbreviations and units shown in the manual

Abbreviation Definition
∅ Diameter
ASTM American Society for Testing and Materials (www.
astm.org)
EC European Community
EMC Electromagnetic compatibility
CTRL Control key on the computer keyboard
EN European norm
F Fast (fuse type)
FUS Fuse
HL7 Health Level Seven (www.hl7.org)
IHE Integrating the Healthcare Enterprise (www.ihe.net)
ISE Ion-selective electrode
IVD In Vitro Diagnostics
LED Light-emitting diode
LIS Laboratory information system
prep Preparation
WEEE Waste Electrical and Electronic Equipment
REF Reference solution for the ISE unit
UPS Uninterruptible power source
TAS Technical assistance service
SD Standard deviation
ES Electrical safety
USB Universal Serial Bus
UV Ultraviolet

Units Definition
" Inch
˚C Degrees centigrade
A Ampere / Absorbance
GB Gigabyte
h Time
Hz Hertz
Kg Kilogram
L Litre
MB Megabyte

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User manual

Units Definition
m Metre
min Minute
mL Millilitre
mm Millimetre
mmol Millimol
mv Millivolt
nm Nanometre
s Second
VA Volt-ampere
V Volt
W Watt
µL Microlitre
µm Micrometre

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16
Software usage licence
BioSystems, S.A., the exclusive owner of all the rights over this computer applica-
tion, grants one non-transferable, non-exclusive licence governing the use of the
computer application to the user, who accepts it solely and exclusively for executing
this computer application in a single central processing unit (CPU) of a computer.
This licence does not permit the execution, use, access, reproduction, transforma-
tion, translation, lease, sale, distribution, commercial exploitation or provision to
third parties in any way, and above all in a computer network or through remote
access technologies, of all or part of the content included in this DVD.
BioSystems, S.A. will in no case be liable or assume payment of any compensation
whatsoever:
with respect to any infringement of the intellectual and/or industrial property
rights of others caused by copying images, audio and/or text as part of the content
of this DVD;
due to the exhaustiveness or accuracy of the data incorporated through incorrect
use of the computer application in the DVD;
for damages, losses or indirect, special, incidental or consequential damages to
people or property due to the incorrect use or putting into practice of any of the
methods, theories, products, instructions, ideas or recommendations included in
this DVD or which make reference to its content.
The computer application in this DVD is delivered with no guarantee of the
results obtained following incorrect use or adaptation for a specific purpose. The
user fully assumes all risks with regard to the results obtained by incorrect use of
the computer application.
None of the contents of this usage licence grants the user any intellectual or indus-
trial property rights over the confidential information of BioSystems S.A., and/or
of persons with rights over the content of this DVD.
The licence granted and constituted pursuant to these terms and conditions will
be interpreted in accordance with and governed by Spanish law, with the jurisdic-
tion being the courts of the city of Barcelona, Spain. The user waives any other
applicable legislation and/or jurisdiction that is competent, if any.
The user of this licence knows and agrees that the user licence grants no rights
over the use of computer programmes and/or applications belonging to others
that may be used or which may be necessary for using or operating this computer
application, for which the user will obtain the respective legitimisation of use.

17
User manual

1. Intended use
The BA200 analyser is used to determine analyte concentrations by in vitro bio-
chemical, turbidimetric and electrolyte measurements of human samples of serum,
urine, plasma, cerebrospinal fluid or total blood.
The BA200 analyser is optimised to work with the BioSystems biochemical, turbi-
dimetric and electrolyte reagents line. Reagents not included in the BA200 analyser
validation performed at BioSystems SA require a full and exhaustive validation by
the user or the laboratory.
We recommend a validation of the overall operation of the analyser and of the
reagents by the laboratory, taking into account the preanalytical phase and any
other relevant aspect.
The analyser is exclusively for professional use, i.e., for users who have the ap-
propriate training and expertise to use it. In addition to how to install the instru-
ment, users are instructed on the operation of the analyser and the software that
goes with it.
The environmental conditions for the functioning of the analyser are normal
clinical analysis laboratory conditions. These conditions are described in the
specifications chapter.

2. Contents
The elements that the user will find on unpacking the analyser are listed below.
Make a visual check to ensure that none of the elements has suffered any apparent
damage during transport.
1. Analyser.
2. Unpacking instructions sheet.
3. Analysis certificate sheet (Instrument Release Certificate).
4. Accessory box (supplied separately in a different box from the analyser).

2.1. Content of the accessory box

Accessory Description
Empty 60 mL reagent bottles (5)

Empty 20 mL reagent bottles (5)

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Accessory Description
Labels for identifying the empty bottles.

Reaction Rotor (10)

Reagent and samples rotor

Labels to identify the rotor positions

Sample wells (1000)

Bottle of concentrated washing solution

(500 mL)

Bottle of acid washing solution (20 mL)

(1)

Paediatric adapter (50)

Tube adapter (50)

DVD with the user programme and user

manual.

Mains connection cable, European plug

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User manual

Accessory Description
Mains connection cable, American plug

USB cable.

Fuses (2).

Connection tube for purified water

bottle (2). One Ø 10 mm tube and
another Ø 6mm . Both blue coloured
(3 m).

Connection tube for waste. Red tube

(3 m).

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20
3. Identification of the main components
The different component parts of the analyser are marked and numbered in the
following figures and their associated lists:

3 5 6 4 7 2 1 8
Figure 1 Main components

1– General cover 6 – Dispensing arm

2– Reagent and samples rotor 7 – Wash station
3– Bottle and ISE module access door 8 – Switches
4– Reaction rotor cover
5– Stirring arm

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User manual

4
6 5
Figure 2 Rear view components

1 – Rear cover handle 5 – USB connection

2 – Ventilation outlet 6 – Main voltage switch
3 – Distilled water and waste
connection
4 – Adjustable leg

4 5
Figure 3 Internal components
1– LED status lamp 5 – Cleaning solution bottle
2– ISE module
3– Reagent kit for ISE module
4– High contamination waste bottle

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22
4. Installation

4.1. Location
Location Install the analyser in a large space. It occupies a minimum space of
107 cm x 75 cm.
Leave a space of at least 10 cm behind the analyser for the air to circulate from
the fan outlet.
Leave a space of least 70 cm above the analyser to allow the main cover to be opened.
Leave a space of least 40 cm at the front to allow the doors to be opened for ac-
cessing the ISE module.
Leave a space of at least 40 cm on the left side to allow room for accessing the
partial and general switches.
Environmental conditions Install the analyser in a dry, non-corrosive environment. The relative humid-
ity should not exceed 85%, with no condensation. It is advisable for the room
temperature to be less than 35 °C or 30 °C in the event of using the analyser
ISE module. Do not install the analyser in areas that are exposed to draughts.
Lighting Do not place the analyser below potent light sources. Keep the lighting as stable
as possible and ensure that no flashing light falls directly on the analyser. Direct
sunlight should also be avoided.
Electromagnetic radiation Make sure the analyser is not near any electromagnetic radiation sources (such
as motors, centrifuging appliances, mobiles telephones) or heat sources.
Anchoring Move the analyser to its definitive location by pushing it gently.
Once in the final position, anchor it. Unscrew the four adjustable legs (1) until
they touch the table. (See Figure 4).
Level the analyser by lengthening or shortening the legs, as necessary. Use a span-
ner to turn the nut (2) (See Figure 5).
When it is properly levelled, secure the nuts by turning the counter nut (3) to
the upper limit.
Do not turn the nut too much (3) to prevent the leg from being separated from
the structure.

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User manual

1 1 2 1 1
Figure 4 Adjustable legs and front cover opening

3
2

Figure 5 Securing the legs

4.2. Front door opening

The front door is located on the left side of the analyser (2). Press the front of the
door with your hand to release the magnet that keeps it closed. Slide the door
outwards to open it. To close the door, guide it until it touches the magnet. Then
press the contact point to return the door to its original position.
))See Figure 4

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24
4.3. Installing the waste containers and washing solution.
If you open the front door, you will see two bottles inside. The one on the left
with red cap is the high contamination waste bottle (1) and the one on the right
with green cap contains the washing solution (2). See Figure 6.
To handle the bottles in safety, leave them on the front door after opening it, to
enable the tubes to be disconnected and connected. The door is designed to sup-
port a weight of no more than 6 kg.

1 2 3
Figure 6 Location of the waste bottles and washing solution

4.3.1. Preparing the washing solution

1. Unscrew the cap of the washing solution bottle (5).
2. Fill it with 2.4 L of purified water.
3. Add 12 mL of the concentrated washing solution (code AC16 434) and mix
gently. Take care in handling the concentration washing solution bottle, to
prevent the contents from splashing or spilling. Wear gloves and protective
NOTE clothing when handling it.
4. Screw on the cap, connect the tubes and place it in its housing inside the
analyser.

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User manual

4.3.2. Emptying the high contamination waste container

The high contamination waste container (4) is supplied with a fast connector fitting.
1. Press the fast connection fitting on the cap and take the container out of the
analyser.
2. Unscrew the container cap.
3. Empty the container.
4. Screw on the container cap, insert the tube with the fast connector and place
in the container in its housing inside the analyser.
Make sure that the fast connector fitting is properly inserted into the container
cap. To do this, when inserting the fitting, you should hear a “click”. If not, this
means it has not been properly inserted.
NOTE

Dispose of the waste in accordance with the applicable national or local govern-
ment legislation governing the disposal of dangerous biological waste.
Handle the high contamination waste container with care. Wear gloves and protec-
BIOHAZARD tive clothing when handling the container.

4.4. Purified water connection

The analyser has two purified water inlets at the rear. See Figure 7.
Once the user programme has been installed, configure the water inlet selection,
depending on the connection made.
))See water inlet selection in chapter 10.2.1
Mains water inlet This connection is used by laboratories which have a centralised purified water
production system.
1. The circuit water pressure in that tube must be between 0.5 bar and 4 bar.
2. Connect the blue tube in the accessory box to the top connector (1). It is
marked “MAINS WATER INLET”. Connect the other end to the water mains.
3. Ensure that the central purified water system output is fitted with a filter. If
there is no filter, one must be installed between the purified water production
NOTE
system and the analyser.
Filter specification Filtration < 5 µm
Tank water inlet For laboratories which do not have a centralised purified water production
system, an auxiliary tank is used to supply the purified water.
1. Place a purified water tank (60 L provide 6.7 h of autonomy) at the side of
the equipment. This tank must be on the same level as the analyser.
2. Connect the thin blue tube supplied with the accessory box directly to the
lower connector (3). The connection is marked “WATER TANK INLET”. Insert
the other end in the base of the external tank. There is a connection with a
weight in the accessory box. Connect it to the end of the tube to ensure the
tube does not bend.

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26
 1

Figure 7 Liquid connections

1 – Distilled water intake from 3 – Distilled water intake from external
mains tank
2 – Low contamination waste outlet

4.4.1. Positioning the tubes

The analyser has a fast connector system for connecting the water and waste tubes.
))See Figure 8
Connecting the tube To connect any of the tubes, insert the tube (1) into the connector as far as it
will go. Pull the tube outwards to block the nozzle (2) and ensure it is sealed.
Disconnecting the tube To disconnect the tube (1), press the nozzle inwards (2) to release the tube. Pull
it to remove it.

Figure 8 Tube anchoring system

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User manual

4.5. Low contamination waste connection

Dispose of the low contamination waste in accordance with the applicable legis-
lation of the country in which the analyser is installed. Such waste is extremely
diluted.
NOTE

Connection Insert the red tube of the accessory box into the central connector of the analys-
er (2). See Figure 7. It is marked “LOW CONCENTRATION OUTLET”. Place
the other end of the tube directly in the drain if the legislation of the country
allows this. If not, install an external tank and connect the tube inside it.

4.6. Installing the sample and reagent rotor

The sample and reagent rotor is in the accessory box. Remove it and place it in
its position.
The rotor has an 88 position capacity for reagent bottles and/or samples (they can
be placed in the primary tube or the sample well). The positioning of the bottles
and samples is fully adaptable to the needs of the laboratory.
The compartments are already prepared for the reagent bottles to be placed in them
directly. The 60 mL bottles must go on the inner ring, while the 20 mL bottles
may be placed on the inner or outer ring.
For sample positioning use the adapters (2). Adapters can be located wherever
position you want to use and are positioned with the longitudinal opening facing
outwards to permit the bar code laser scanner reading. Press hard until you hear
a “click” indicating the correct entry of the fastening tab. The adapters (2) can be
removed from their position by pulling them outwards.
))Figure 9 shows how to place the adapters for samples.
The primary tubes (4) with diameters of 14 mm and 15 mm are inserted directly
into the adapter.
To use the 13 mm diameter tubes and sample wells the adapter must first be put
in place (1).
It is advisable to place the samples on the outer ring and the reagent bottles on the
inner ring. In the event of requiring a higher capacity for samples, the adapters
can also be placed on the inner ring.

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 1

Figure 9 Placing the adapters for tubes and sample wells

Replacing the rotors To remove the rotor in order to easily install the sample tubes or reagent bottles,
proceed as follows:
1. Remove the rotor cover.
2. Press the central button on the handle to release the rotor.
3. Remove the rotor from its housing. Be careful, as if the rotor is full, it may
weigh up to 5 kg.
4. When reinserting the rotor into its housing, press the release button and let
NOTE
the rotor descend as far as it will go. Turn it until the positioning tab coincides
at the base and is correctly seated.
5. When inserting a full rotor into the housing, ensure it descends slowly without
falling, to prevent it from knocking against the base and the reagent bottles
from splashing.
6. Place the cover of the rotor on its housing. Ensure that it is properly seated
in the housing, it has only one position.

NOTE

4.7. Specifications of the barcode labels

To ensure good detection with the barcode reader, the tube labels should be com-
pliant with the following specification regarding their position.

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User manual

 

 






 



 

 

Figure 10 Positioning of the label on the primary tube

• Respect the barcode label position margins, as shown in Figure 10.

• It is advisable to have a minimum width of 3.5 mm between the edge of the
label and the beginning of the barcode.
• It is advisable for the minimum barcode height to be 10 mm.
• The label is positioned with the bars perpendicular to the tube axis. The label
inclination must be less than ± 7.5% or ± 4.2 SDgr with respect to the sample
container axis.
• It is advisable to use CODE128 for the barcode, but the scanner can also read
CODE 39, CODEBAR, CODE 93 and INTERLEAVED 2 OF 5.

4.8. Affixing the identification labels

The accessory box has identification labels that serve to identify the additional
solutions. Affix them to the tubes or auxiliary reagent bottles. The following chart
shows the colour code and identification for each type of solution.

Label colour Name on label Description Affixing the label

Blank REAG Auxiliary bottle Bottle
Blue DI H20 Purified water Tube / Bottle
Yellow SAL. SOL. Saline solution Tube
Green WS1 Washing solution Bottle
Purple ISE DET ISE washing Tube
solution
Grey DIL1 Diluent Bottle

Affix each label to the reagent bottles supplied or to the tubes in accordance with
the above chart. When the barcode reader scans the reagent rotor and detects an
auxiliary bottle, the programme will ask you to associate that bottle to a reagent
in the list.

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User manual

4.9. Installing the reaction rotor

1. Start up the analyser and use the rotor change function in the user programme.
))See how to start up the programme in section 10.1
))See functions, rotor change in section 10.9.1
2. When the wash station is at the highest point, remove the reaction rotor cover.
3. Remove the rotor fixing screw.
4. Take a rotor from the accessory box. Hold the rotor by the tabs and not by
the wells, to avoid the optical window becomes dirty.
5. Insert the methyl acrylate rotor into the reaction rotor, ensuring that the rotor
does not touch the tips of the wash station.
6. The rotor only has one position and must be correctly fitted into the support.
7. Screw the rotor fixing screw as far as it will go.
8. Place the cover of the rotor on its housing. It only has one position.
9. Finalize the rotor change operation with the user programme.

4.10. Connection to the mains and start-up

It is very important to connect the analyser and computer to an appropriate
electricity system. It must be as exclusive as possible and it must have an earth
connection. The analyser and computer must have the same earth connection.
Mains plug cable Use the mains plug cable supplied in the accessory box. The use of a cable not
supplied by the manufacturer can pose a safety problem.
Supply voltage 115 V to 230 V
Supply frequency 50 Hz or 60 Hz
Power 500 VA
The analyser automatically adapts to the mains voltage without having to select the
voltage manually. Working outside the voltage range could cause the equipment
to malfunction and cause damage to it. The electrical installation category must
be II (surge voltage category).
Fuse The accessory box contains a set of spare fuses. The characteristics are:

Fuse Model Code

10A 5SF10L250V AC16747

The fuse is located in the rear main switch (1).

))See Figure 11
Changing the fuses Remove the protective cover (1) and replace both fuses with those supplied in
the accessory box. Always replace both fuses at the same time.
It is advisable to use an uninterruptible power source (UPS) to protect the analyser
and computer. The recommended characteristics are:

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31
 Model continuous UPS (on-line)
Power 1.5 KW
Battery capacity Over 15 min

Figure 11 Fuse location

1 – Main switch

Figure 12 Analyser switches

2 – ISE module switch (optional) 4 – Analyser switch
3 – Refrigeration system switch

Electrical connection Proceed as follows:

1. Ensure that the three switches on the right-hand side are in the disconnected
position (O) and that the general mains switch (1) is also on disconnected.

32
 2. Connect the mains cable firstly to the appliance and secondly to the mains.
3. Put the general switch (1) to the connected position (I).
4. There are three separate switches, one for the analyser, another for the refrig-
erator and a third for the ISE module.
5. To turn on the analyser, put the switch (4) to the connected position (I).
6. To turn on the refrigerator open the protective cover and put the switch (3)
to the connected position (I).
7. To turn on the ISE module open the protective cover and put the switch (2)
to the connected position (I).

4.11. Connection to the computer

The computer must be fully dedicated to the operation of the analyser. No other
application must be used while the analyser is operating.
The connection is made through USB.
USB connection The computer must be switched off.
Connect one end of the USB cable to the analyser and the other to a USB port in
the computer.
Do not use a USB concentrator (hub) to make the connection.
))See installing the USB driver in section 4.12.
))See communications setup in chapter 10.2.1
Auxiliary USB connections At the rear of the appliance there are 2 service ports for restricted use. These
ports are not used for connecting the software with the analyser.
Be careful when handling liquids to avoid splashing or spill that could occur on
the PC that is connected to the analyzer.

WARNING

4.12. Installing the user programme in the computer

The user programme must be used in a PC that is compatible with the following
minimum requirements:
• Operating system: Windows® 7 (x64), Windows® 10 (x64)
• CPU: Equivalent to Intel Core i3 @3.10 GHz or higher
• RAM memory: 4 Gbytes
• Free space of 40 Gbytes in hard disk
• DVD player
• SVGA monitor, minimum resolution 1 024 x 768
• USB serial channel connector

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User manual

Ensure that no Microsoft SQL server version has been previously installed in the
computer. To verify this, open the following programme in Home:
Control panel\All Control panel elements\Programmes and characteristics
and check there is no input with the name: Microsoft SQL server
Install the program by proceeding as follows:
1. Insert the disk into the DVD drive of the computer.
2. Press Start, select Execution and write:
3. D:\setup\setup.exe, or the name of the DVD unit
4. Follow the steps indicated by the installer programme.
5. The installer program automatically installs the application programme, the da-
tabase manager and USB controller driver without the user having to intervene.
6. The database manager installation process may take some time; wait until the
installation process has ended.
7. Configure the display of operating system with the following characteristics:
• Select All settings
• Select System
• Select Display
• Select Resolution 1024 x 768
• Select Scale and distribution: 100%
))See Figure 13
8. Disable the screen saver
• Select All settings
• Select System
• Select Power&sleep
• Select Never, in all the options
))See Figure 14

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34
Figure 13 Screen of text configuration

Figure 14 Options of Screen saver

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User manual

4.12.1. Energy options configuration

• Select All settings
• Select System
• Select Power&sleep
• Select Related configuration options, Additional power configuration
• Select Change plan configuration
• Select Never in the option Disable display, Put the equipment in sleep mode
• Select Change advanced power configuration
• Select USB configuration
• Select the option Disable in Selective USB/Configuration suspension configuration
• Save the changes

Figure 15 Power options configuration

Figure 16 Change the Power options

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36
 Figure 17 Change the USB power options

4.12.2. Configure programmes in second plane

Do not execute programmes in background while the application is in operation.
To do this, change the programming of the following programmes:

4.12.2.1. Flash updates

1. Access Home, Control panel
2. Access the flash player icon
3. Access the advanced tab and select the option Never search for updates.

Figure 18 Flash update

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User manual

4.12.2.2. Java updates

1. Access Home, Control panel
2. Access the Java icon
3. Access the Updates icon and uncheck the option Check updates automatically.

Figure 19 Java update

4.12.2.3. Operating system services configuration

Cancel unnecessary services with no dependency on the application. Proceed as
follows:
Proceed as follows to change the service options:
4. Access Home and execute the msconfig programme
5. Select the Services tab
6. Deactivate the following services:

Visible name Service name

Adobe Acrobat Update Service AdobeARMservice
Auxiliary IP application iphlpsvc
Non-connected files CscService
Distributed links follow-up client TrkWks
Publication of function detection resource FDResPub
Diagnostic directives service DPS
Windows Search WSearch

7. Save the changes.

8. Reboot the computer.
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38
4.12.3. Cyberseurity configuration

4.12.3.1. Execution rights

For security it is necessary to execute the application with a user with low right
access to the computer.
To do this creates a new user with low right access to the computer. Follow the
following steps:
1. Select All settings
2. Select the Accounts option
3. Select the Family and other people option
4. Select the Add another person to this computer option
5. Create the account with the name of the operator that will access the equi-
pment.
6. Restart the computer with the operator’s user.

4.12.3.2. Configure the application user rights

Create as many users in the BA400 program as there are operators in the laboratory.
Assign the relevant rights to each user, if he is a supervisor or operator user
The supervising user is allowed to modify the concentration values of the calibrators
and controls in addition to the functionality of the operator. The operator user
only creates the work lists, positions and executes them. The operator also view
the results, print them and / or send them to the host.
See chapter 10.2.8 how to create users and assign rights.

4.12.3.3. Activate and configure the operating system antivirus

Activate or install one of the following antivirus systems:
• Windows defender (Microsoft ™)
• ESET Endpoint antivirus
Configure the antivirus system as follows:
To configure the windows firewall, follow the steps below:
• Select All settings
• Select Update and security
• Select Windows defender
• Select Open security center of windows defender
• Click on the option of antivirus protection and against threats
))See Figure 20
• Select Antivirus Settings and Threat Protection
• Activate the option of protection in real time

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User manual

• Activate the Cloud-based protection option

• Deactivate the other options
))Véasae Figure 21

Figure 20 Windows defender configuration screen

Figure 21 Antivirus configuration screen

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40
4.12.3.4. Run the antivirus before installing the application
Before installing the BA400 application run the antivirus program to make sure
that the system is clean of viruses.
Follow the following steps:
• Select All settings
• Select Update and security
• Select Windows defender
• Select Open windows defender security center
• Select Advanced Exam
))See Figure 22
• Select Complete Exam

Figure 22 Antivirus execution screen

4.12.3.5. Do not install any extra program

Install only those programs in the system you are going to use. Antivirus programs,
communication system with the host.
Do not install any other extra program as this may affect the security or stability
of the application.

41
User manual

4.12.3.6. Update of windows versions

The windows 10 operating system comes configured with system updates enabled.
Configure system updates at times when the analyzer does not work.
Follow the following steps:
• Select All settings
• Select Update and security
• Select Windows update
• Select Change active hours
• Set the hours when the analyzer will be running. During this time it will
prevent the computer from restarting.
))See Figure 23
• Select the Restart options
• Activate the Show more notifications option
))See Figure 24

Figure 23 Active hours configuration screen

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42
Figure 24 Restart options

Windows and antivirus updates can cause a lack of compatibility that affects the
operation of the BA400 software: User Application, Service application or Com-
munications Libraries with LIS.
To quickly recover the operativeness, we recommend that you program the au-
tomatic and periodic realization of points of restoration of the operating system.
If you detect a compatibility problem after an update, immediately report the
problem to your Technical Service, attaching a SATReport and the date on which
you observed the problem. While Biosystems analyzes the problem and designs a
solution to guarantee compatibility, restore the operating system to the last date
with stable operation, this will allow you to continue working.
Follow the steps to configure the restore points:
• Select All settings
• In the search bar type: Create a restore point
• A window opens to configure the restore points
• Select OS C Unit: (system) and press Configure
))See Figure 25
• Enable system protection and configure the maximum disk space that will be
used for system protection. Select how at least 10 Gbytes

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User manual

Figure 25 Restore point configuration screen

4.12.3.7. Verification of the integrity of the application

As a security measure, the application incorporates a control system to verify the
integrity of the application.
If any of the files in the application is modified, the application detects it and
prevents it from being executed.
If you encounter the error in Figure 26, call the technical service to perform a
reinstallation of the application.

Figure 26 Screen of verification of the application integrity

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44
4.12.3.8. Backup of the data
Each time a session is reset, the database is backed up.
You can locate this backup in the following folder:
c: \ Users \ [User name] \ documents \ BA400 \ RestorePoints \
Where [User name] is the username to enter the system.
The last 10 backup copies are saved. The oldest copies are erased.
This file is password protected. It can only be opened with the application. Through
the sat-report reading option.
Configure a method to make copies of these files out of the system. So that in case
of system failure you can recover the data without problems.

4.12.3.9. Recovery of the main password

In case of forgetting the main password of the application, call your usual distribu-
tor to tell you how to recover the password and be able to access the application.

4.12.3.10. Connection to a host

For those BA400 application that are connected to a host, activate the windows
firewall or an alternative one provided by the systems administrator.
To configure the windows firewall, follow the steps below:
• Select All settings
• Select Update and security
• Select Windows defender
• Select Open windows defender security centre
• Click on the Firewall and network protection option
))See Figure 27
• Verify that for the three network classes (domain network, private network
and public pred) the firewall is activated
• Select Public network
• Enable the firewall of windows defender and block incoming connections
))See Illustration 26

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User manual

Figure 27 General Firewall configuration screen

Figure 28 Firewall configurtion screen

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46
4.12.3.11. Use a VPN system
For those systems that require the privacy of the data during communications
with the host, use the VPN (Virtual Private Network) in the windows system to
perform encrypted communications with the host.
Follow the following steps:
• Select All settings
• Select Network and internet
• Select VPN
• Select Add a VPN connection and configure the configuration options according
to the data of the system administrator or the VPN provider.

4.13. ISE module installation (optional)

Figure 29 Order for positioning the different electrodes

Electrode installation After opening the front cover the ISE module can be directly accessed. See Fig-
ure 23.
1. Turn off the ISE module power supply.
2. Unscrew both screws by hand (1) and remove the cover (2) to access the
compartment for positioning the electrodes.
3. Unpack each electrode. Ensure that the sealing ring (O-ring) is in position.
Carefully dry any traces of liquid.
4. First put the reference electrode in position. Pull out the identification wire
with a label that is connected inside the electrode circulation channel. Ensure

47
User manual

there are no traces of salt in the channel. Keep the wire with the label in case
you need to uninstall the electrode.
5. To insert the reference electrode press the yellow tab downward (3) and insert
it as far as it will go. Then release the tab.
6. Insert the other electrodes in the positions shown in Figure 23. Check that
their sealing rings (O-rings) are correctly positioned. Carefully dry any traces
of liquid.
7. Each electrode has a single position to prevent errors in putting them in place.
8. In the event of not having a Li+ electrode, insert an empty electrode in its place
(it is marked by a line of dots), to close the channel pathway.
9. Release the yellow button to supply pressure to all the electrodes and ensure
good fluid communication.
10. To ensure that the electrodes are properly placed, press them at the front until
you hear a click or they have been correctly seated.

Figure 30 Tube connection

Tube installation Insert a tube into each peristaltic pump. To insert the tube into the head of the
peristaltic pump release the pressure on the head by pulling to the side of the
clamp, see Figure 24.
Each tube has two labels. The labels help guide the tube correctly in the peristaltic
pump. The number on the label of each tube must coincide with the number on
the pump label.
• The tubes marked W must be installed in the pump (6). The order for putting
them in place starting from the bottom is W1 and W2.
• The tubes marked B must be installed in the pump (5). The order for putting
them in place starting from the bottom is B2 and B1.
• The tubes marked A must be installed in the pump (4). The order for putting
them in place starting from the bottom is A2 and A1.

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48
 Take care when connecting the tubes of the waste pump (6) as they are connected
in reverse order to the tubes of the pump for calibrators A (4) and B (5).
Installing the reagent kit Unpack the kit, remove the three red protective caps from the connections and
the red warning label. Keep the caps in case you need to uninstall the reagent
kit. Position the connector in the correct direction and press lightly until you
hear a “click”. Write the installation date on the side of the kit.
Do not press the sides of the box too strongly or put the reagent kit face downwards
without the caps, as the reagent could be spilled. It is advisable to wear gloves when
performing this operation.
NOTE
Place the kit in its housing.
With the user programme, execute the actions in the number and order indicated
in the Installation/Activation optionof the ISE functions section.
))See chapter 10.9.3

Step Action Repetitions Description

1 Initialise 1
ISE
module
2 Activate 1 If the execution icon is not activated after
the selecting this option, check that it is a new
reagent kit. If the kit has already been activated
kit before, this option will not be available,
but you can make a reading with the Read
reagent Kit option. In this case, go on to
the next instruction. In the event that it
is a new kit, check that the connector is
correctly positioned, remove it again and
reconnect it.
3 Read 1
reagent
kit
4 Prime B 9 Remove the lower cover of the stirrer arm,
which allows you to observe the dispensing
cup. Observe the cup and check the
emptying operation, i.e., that every time
the module pumps dispense the liquid
into the cup, it is emptied before the next
dispensing operation. If the pumps do
not dispense the liquid, execute the above
action again. If, after repeating it several
times, no liquid is dispensed, disconnect
and reconnect the kit adapter and repeat
the action.
))
See chapter 14.2.9
5 Prime A 9 Proceed as described above

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User manual

Step Action Repetitions Description

6 Date of 1
installing
the tubes
7 Calibrate 1 If no satisfactory result is obtained, check
the that the tubes are correctly installed and
pumps execute the actions from step 4.
8 Activate 1 Indicate the installation date. If any of the
the electrodes is not new, record them again
electrodes with the original installation date.
9 Prime and 2 Execute this action to calibrate the
calibrate electrodes with the new solution and
check it is in good condition. If the result
is unacceptable due to the presence of air,
check that the solutions are circulating
correctly and repeat steps 4 or 5,
depending on the error reported. If the
calibrations have ended but the results are
not acceptable, repeat these instructions a
couple of times.
10 Wait 5 1
minutes
11 Prime and 1 If the calibration of the last measurement
calibrate – is not acceptable, wait 5 more minutes and
end repeat the actions from step 9.
12 Activate 1
the ISE
module

4.14. First steps for operating the analyser

1. Replenish the washing solution tank.
2. Connect the distilled water inlet tube and the low contamination waste outlet
tube.
3. Connect the electric mains cable to the analyser.
4. Install the program in the computer.
5. Install the sample and reagent rotor.
6. Install a reaction rotor.
))See chapter 4.9
7. Close all the covers.
8. Connect the analyser to the computer using the USB communication cable.
9. Turn on the analyser. Wait until you hear a beep.

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50
 10. Select the Communications configuration tab in the General submenu of the
Configuration menu.
11. Select the automatic option.
12. In the same menu select the Analyser tab.
13. Selection one of the two water inlet selection options, depending on the water
inlet installation.
))See chapter 10.2.1
14. Press the initialisation button on the analyser.

15. Perform 5 conditionings to ensure that the internal water tank fills up and that
the fluidic system is correctly primed.
))See chapter 10.9.2
16. In the event of having an ISE module, install the electrodes and reagent kit.
))See chapter 10.9.3
17. Fill in the calibrator concentration fields and controls of the tests to be used.
))See chapters 10.3.5 and 10.3.6
18. Make a list of blanks, calibrators and controls.
))See chapter 10.5.3 and 10.5.4

4.15. Cautions during operation

• In analysers with the ISE installed, you mustn’t turn off the module switch.
The module automatically performs a priming cycle from time to time. To
turn off the ISE module follow the steps indicated in chapter 14.3.2.4
• To maintain the reagents refrigerated when the analyser is off, leave the refrig-
erator switch in the on position.
• When the analyser is operating, do not open the main cover without first press-

ing the Pause button. In the event that the main cover opens unexpect-
NOTE edly, the analyser will stop any action it is performing, and the preparations
already made in which the sample has not yet been dispensed will be lost.
• Ensure that the sample, reagent and reaction rotor cover are on while the
appliance is operating. The analyser will not perform any operation if any of
these cover is missing.
• Keep the analyser work surface free from obstacles that could collide with the
preparation or stirring arms.
• Make sure the barcode labels on the sample tubes are correctly affixed and
properly centred. They must be aligned properly on the tube. If the label has
a barcode with only a few digits affix it lengthwise and centered, without plac-
ing it on the top part of the tube. Position the sample tube with the barcode
label facing outwards.

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User manual

• Do not duplicate any sample tube identification code on the barcode labels
during the same session. If several sample tubes have the same barcode identi-
fier while the equipment is enabled for working with LIS communications,
NOTE the analyser will not automatically assign any test to those tubes and it will
display a message indicating this on the screen. In the case of manual opera-
tion (without LIS communications), first the analyser will pipette the tube
that is in the lowest position in the sample rotor.
• The positions of the sample tubes and reagent bottles must be maintained when
the Automatic Barcode Verification is not used before starting / continuing
the work session.
NOTE
• When using sample tubes of 15 mm in Ø or with a capacity of 15 mL, do not
fill them to the brim with the sample. Fill them with no more than 14 mL in
order to correctly detect the sample.
• Use the positive identification of sample tubes whenever it is possible. That
is, use the bar code to identify sample tubes. This will prevent possible errors
in the placement of tubes in the rotor of samples.
NOTE

4.16. Preanalysis and preparation of additional solutions

Reagents Follow the usage and safety instructions set out in the IFU (Instructions for
Use) of the reagents for their preparation and handling.
Before using the reagent for the first time, check the test programming against
the programming supplied with the reagent. Only the last version of the Software
may contain the last programming for all the tests. We strongly advice to update
software to its latest version.
In the case of reagents with contents that must be homogenised, do this gently,
without shaking them. If air bubbles have formed on the reagent surface, elimi-
nate them.
When changing the reagent lot, make sure you perform the blank and calibrate
the test.
It is recommended to perform a reagent blank when changing the reagent bottle
and/or in accordance with the frequency established by the IFU.
Condensation could form on the walls of the reagent bottle, on the neck of the
bottle or on the barcode labels. If condensation is present, eliminate it with an
absorbent paper towel.
Primary serum tubes For the correct operation of the analyser, carry out the sample preanalytical
phase on serum tubes as follows:
1. Obtain the sample by venous puncture in a tube without anticoagulant. Fill
the tube to at least 2/3 of its total volume.
2. Let the blood stand for 20-30 min to allow the clot to form.
3. Centrifuge the tube for 10-15 min, or follow the primary tube manufacturer's
instructions.

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52
 To obtain precise results, the samples must be free from clots, fibrin, etc., which
could block the sample tip or ISE module reader channel. Also check that the
serum has no air bubbles.
NOTE If using a tube with serum separator gel, check it has sufficient serum volume in
order to avoid inserting the sample tip into the gel layer. This could block the tip.
Never insert samples that are extremely lipaemic and/or haemolysed.
Primary plasma tubes Plasma tubes can be used only for those tests already validated (see IFU). Pro-
ceed with the sample preanalytical phase of the plasma tubes as follows:
1. Obtain the sample by venous puncture in a blood collection tube with an
anticoagulant. The anticoagulant must be compatible with the determinations
that have to be made.
If this sample is to be used for measuring ISE determinations, heparin sodium
must be used as an anticoagulant. The heparin level should not exceed 15
UI/ml of the tube volume. Do not use heparin ammonium, heparin lithium,
EDTA or NaF tubes.
NOTE
2. Mix the sample by inverting the tube several times. Do not shake it.
3. Centrifuge the sample for 10-15 min within one hour of collecting or follow
the manufacturer’s instructions. Carefully remove the plasma layer at the top
for analysis. Use a Pasteur pipette or a syringe fitted with a blunt-tipped needle
for this procedure. Make sure the cell phase is properly separately from the
aqueous phase.
Dilution of urine for ISE If wanting to make ISE determinations in urine, the urine must be diluted. Per-
form the dilution manually outside the analyser with a dilution factor of 1/10
and a diluent code of 5412 or 5408.
• The analyser uses 200 µL to make an ISE determination in urine. Prepare a
larger quantity of diluted urine.
• Take one part of the urine and pipette it into a primary tube or paediatric vial.
• Take nine parts of the urine diluent (it is in the ISE module accessory box)
and pour it into the same primary urine tube.
• Mix it and place it in the sample rotor.
ISE washing solution Every day in which ISE determinations are made you should wash the module
to remove proteins from the fluidic canal. It is advisable to perform this washing
operation at the end of the day.
The ISE module accessory box contains the ISE module washing solution kit. It
has 6 bottles with washing powder (peptin) and a diluent.
• Add the diluent until the peptin bottle (12 mL) is full, shake it well and take
note of the preparation date
• When it is not in use, keep it in the refrigerator.
• Discard it 4 weeks after preparing it.
Washing solutions The washing solutions supplied with the equipment are of two types, the wash-
ing solution (WS) used for internal washing of the tips and reaction rotor and
the acid washing solution (WS1) used to prevent contamination.

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The washing solution (WS) is prepared in the 2.4 L bottle located on the left side
of the front of the equipment.
The acid washing solution (AC17201)(WS1) is installed in the reagent rotor. It
is supplied in 20 mL bottles.
Handle these solutions with care and wear the appropriate clothing and gloves.
Never mix both washing solutions as they could give off dangerous gases.

5. Transport and reshipment

The analyser weighs 166 kg. The analyser has legs made of hard plastic to allow
it to be moved on a smooth surface when it is necessary to access the rear part.
If it should be necessary to reship the analyser or move it using a haulage vehicle,
the polar arms must be immobilised, and the analyser must remain in its original
packaging to ensure it suffers no damage. To repack the analyser, follow the in-
structions on the unpacking sheet, in reverse order.
Use mechanised means (fork-lift truck or pallet jack) to transport the packaged
analyser.

6. Handling and storage

Remember that it is a precision instrument and must therefore be handled with
special care.
If the analyser must be stored for long periods of time, heed the following recom-
mendations:
1. Empty the high contamination waste tank and washing solution tank.
2. Remove and store the ISE module electrodes.
3. Remove the tubes from the peristaltic pumps of the ISE module
))See chapter 14.3.2 on ISE module maintenance.
4. Dispose of the reaction rotor.
5. Protect the analyser from dust and environmental aggressions, and from direct
sunlight and excessive damp.
Environmental conditions for storage:
Storage temperature 10 °C to 40 °C
Humidity conditions < 85% with no condensation
during storage

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7. Operating principle
The analyser has various operating states: Warm-up, standby, running and pause.
Sleeping state During this state the analyser is stopped and all its electronic systems are
dormant, to save energy. The analyser will not perform any operation until the
warm-up state is activated.
Warm up state During this state the analyser initialisation process is started. The initialisation
process consists of the conditioning of the fluidic system and thermostating
the reaction rotor so that it reaches the correct temperature and ends with the
rotor baseline execution. The baseline consists of filling all the reaction rotor
wells with distilled water, measuring the absorbance in each well with all the
wavelengths and checking that the measurements are within the ranges. If the
measurements are correct the rotor is emptied and dried. These baseline read-
ings serve to correct the preparation reading absorbances. The whole baseline
reading process takes about 20 minutes.
Stand-by state In that state the analyser waits for the operating state to start. While in this
state, the user can perform maintenance tasks and/or execute the analyser
functions.
Running state During this state the analyser performs several repetitive cycles to prepare the
reactions and take the measurements. The dispensing arm performs two differ-
ent movements, firstly suctioning of R1 and sample and secondly, suctioning
and dosing of R2. A reagent is prepared in the following way:
1. Suctioning of reagent 1 and sample, dispensation in the reaction rotor.
2. Stirring of the reagent 1 and sample mixture.
3. Start the reading period.
4. Suctioning of reagent 2 and dispensation into the reaction cuvette 5 min.
after dispensing R1.
5. Stirring of the mixture with the second reagent.
6. Finalise the reading processes.
7. Washing of the cuvettes.
The reading process is based on the optical absorption spectrophotometer prin-
ciple. The concentration is determined by comparing the luminous intensity of
a certain wavelength that passes through the cuvette when there is a reaction and
when there is no reaction. In some cases the concentration is a direct function of
the absorbance and in others, it is a function of the change of the absorbance over
time, depending on the analysis mode.
Pause state During this state the analyser stops the sample and reagent dispensing process,
allowing the user to access the sample and reagent rotors and to add new sam-
ples or replenish reagents. During this state, the analyser continues to perform
the reaction rotor reading process.

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8. Description of the analyser

Each of the different parts of the analyser is described below.
The main parts of the analyser are:
• Cover and lids
• Sample and reagent rotor
• Reaction rotor
• Dispensing arm
• Stirring arm
• Wash station
• ISE module (optional)
• Electrical and communication connections
• Fluid connections
• Washing solution and high contamination waste bottles

8.1. Cover and lids

The following figure shows the different covers and lids of the analyser

2
3

Figure 31 Covers

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 1 – Main cover 5 – Washing Solution and HCW Bottles
2 – Reaction rotor cover and ISE module front door access
3 – Sample and reagent rotor cover
4 – LED status lamp

Main cover This covers the surface of the analyser. Open this cover to access the reagent,
sample or reaction rotors. To ensure the safe operation of the analyser, this cover
must be kept closed. It has an open or closed casing detector. The analyser will
stop executing the worklist if the cover is opened while it is operating.
Sample and reagent This gives access to the sample and reagent rotor. The patient samples, calibrators,
rotor cover controls and reagents are placed in this rotor. The rotor unit is refrigerated. The
cover has a detector that enables the program to detect the presence of the cover.
Reaction rotor cover This allows you to access the reaction rotor. This rotor is where the reactions are
made and the photometric readings are taken. This rotor is thermostatted at
37 SDgrC. The cover has a detector to allow the programme to detect the presence
of the cover.
Front door It provides access to the washing solution and high contamination waste bottles,
and also to the ISE module (optional unit).
Led status lamp This lamp indicates the analyser state. Possible states:

Colour of LED Description

Off Analyser off.
Orange Analyser in sleep mode (SLEEP).
Flashing orange Analyser in the process of being initialised.
Green Analyser initialised. Waiting for actions mode
(STAND‑BY).
Green light flashes slowly Analyser performing an operation or work
session (RUNNING).
Green light flashes quickly Analyser in pause state. The user can access the
sample and reagent rotor.
Red Analyser with unresolved errors.
Flashing red Analyser performing an action with unresolved
errors.
Table 1 Analyser states indicated by Led lamp

Beeper states The analyser has a beeper that warns the user in the event that an alarm is
triggered.
When the analyser is first switched on (supplied with power), it will carry out a
series of internal checks. Once these checks have been completed the instrument
will generate a short beep, indicating that it is ready to establish connection with
the User Software/Service.
While in the list execution state, if an alarm is triggered, for instance, exhaustion of
reagent, samples, etc., the analyser will indicate this through a beeper that sounds
until the user turns it off manually.

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8.2. Sample and reagent rotor

The sample and reagent rotor consists of a removable drum with positions for
inserting the sample tubes, calibrators, controls and reagents. The system is com-
pletely flexible and samples or reagents can be inserted in any position. The rotor
has a barcode reader for the automatic identification of the samples and reagents
placed on the rotor.

Figure 32 Reagent and samples rotor

Positions There are 88 positions in all, laid out in two rings. The bottle and sample bar-
codes can be read in both rings.
Sample tubes To position the tubes, an adapter must first be inserted (see chapter 4.6 explain-
ing how to position the adapter) Primary tube dimensions:
• Minimum diameter: ∅12 mm
• Maximum diameter: ∅16 mm
• Minimum height: 70 mm
• Maximum height: 100 mm
Sample wells To insert the sample wells in their positions, an accessory is supplied with the
analyser for adapting the diameters. See chapter 4.6 explaining how to position
the adapter.
Bottles 2 types of bottle can be inserted. The volumes of the bottles are as follows:
• 60 mL, only for positioning in the inner ring.
• 20 mL, for positioning in the inner and the outer ring.
Refrigeration The refrigeration system power supply is separated from that of the analyser,
which means the analyser can be switched off and the refrigeration system can
be left on.

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8.3. Reaction rotor
The reaction rotor consists of a thermostatted channel containing an optical-quality
plastic rotor that permits the transmission of UV light.

Figure 33 Reaction rotor

Positions There are 120 positions. The reagent and sample are dispensed into each cu-
vette. While the mixture is reacting the optical reading is taken, to obtain the
absorbance.
Volume The reaction volume is between 180 µL and 440 µL.
Temperature The rotor is maintained at a stable temperature of 37 °C by a Peltier-based ther-
mostating system.
Dispensing cycles for each of the arms:
• Cycle 1: Dispensing Reagent 1 and sample
• Cycle 2: Stirring Reagent 1 and sample
• Cycle 3: Initiation of photometric readings
• Cycle 18: Dispensing of Reagent 2
• Cycle 19: Stirring of Reagent 2
• Cycle 35: End of the reading processes
• Cycles 36 - 46: Washing of cuvettes in the wash station

8.4. Optical system

The optical system generates monochromatic light through the led lamps and
filters unit. The reading system is comprised of two photodiodes. The reference
photodiode serves to stabilise the light and the main photodiode captures the light
that passes through the reaction.

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The optical system is physically located in the reaction rotor, below the wash station.
Wavelengths 340 nm, 405 nm, 505 nm, 535 nm, 560 nm, 600 nm, 635 nm and 670 nm
Measuring range From -0.2 A to 3.5 A
Resolution 0.0001 A
The system automatically performs a cuvette blank of the whole rotor when the
analyser is initialised. This cuvette blank absorbance serves to correct the reaction
absorbance measurements. When the well enters the wash station, it is read again
to check that it is in optimal conditions. If this value exceeds a pre-established
limit, the well is rejected.

8.5. Washing station

The washing station consists of an assembly with different phases, located above
the reaction rotor.
Washing station cycles
• Cycle 1: Suctioning of the high contamination waste and dispensing of the
washing solution.
• Cycle 2: Suctioning and dispensing of the washing solution.
• Cycle 3: Cuvette submerged in the washing solution.
• Cycle 4: Suctioning of the washing solution and dispensing of purified water.
• Cycles 5 and 6: Suctioning and dispensing of purified water.
• Cycle 7: Cuvette submerged in water.
• Cycle 8: Optical check on the cuvette.
• Cycle 9: Suctioning of purified water.
• Cycle 10: Drying.
The purified water for rinsing is thermostatted so that it does not interfere with
the rotor temperature.
When the last rinse is performed an optical reading is also made on the rotor
cuvette. If it is scratched or in poor conditions, the cuvette is discarded and not
used for performing reactions.
If there is a large number of discarded cuvettes, the programme warns of the need
to replace the plastic rotor.

8.6. Stirring arm

The analyser has one arm for stirring the reaction. This arm has a small blade that
rotates inside the reaction cuvettes, to favour mixing and initiate the reaction
correctly.

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 Figure 34 Stirring arm

Cycles Operating cycles of each arm

• Cycle 2: Stirring of R1 and Sample.
• Cycle 19: Stirring of R2.
Once it has stirred the mixture the stirring arm moves to the washing station and
it washes the blade.

8.7. Dispensing arm

The analyser has 1 arm for dispensing the samples and reagents.
The arm has a wash station for washing the interior and exterior of the tip.
Dispensing volumes Minimum and maximum volumes that can be dispensed by the arm:
• Samples: from 2 µL to 40 µL
• Reagent 1: from 90 µL to 300 µL
• Reagent 2: from 10 µL to 100 µL
Detection systems The arm has a level detection system.
There is also a vertical collision detection system to prevent damage to the tip in
the event of accidental collision.
Clot detector The arm also has a clot detector. This system warns the user if the tip is blocked.
The blockage could be due to the clotted blood remains present in the sample.

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Figure 35 Dispensing arm

8.8. Waste containers, purified water and washing

solution
The analyser has 4 containers for storing waste, purified water and washing solu-
tion. All the containers are located inside the analyser.
High contamination waste This container is accessed from the front of the analyser. The capacity of this
container is 2.4 L. It has 20 hours of autonomous operation. The container level
is determined by its weight.
Washing solution It is accessible from the front part of the analyser. The capacity is 2.4 L. The
container level is detected by its weight. It has about 8 hours of autonomous
operation.
Low contamination waste The low contamination waste container is located inside the analyser and can-
not be accessed by the user. The container is emptied automatically. The waste
leaves through the connection in the rear part of the analyser.
))See waste tube connection in chapter 4.5
Purified water The purified water container is located inside the analyser and cannot be ac-
cessed by the user. The container is filled and emptied automatically. The puri-
fied water enters from outside the analyser. It may come directly from a purified
water inlet or from an external container with a larger capacity.
))See Purified water connection in section 4.4.

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8.9. ISE module (optional)
The ISE reader module is optional and serves to determine the concentration of
the Na+, K+, Cl- and Li+ ions in serum, plasma and urine samples.

Figure 36 ISE module diagram

The measurements are taken using ion-selective electrodes. Figure 30 contains a

diagram of the measuring system. A more detailed explanation of the calculation
process is given in chapter 16.5.
The temperature of the room where the analyser with the ISE ion reading module
is located should not vary more than ±4 °C and nor be greater than 30 °C.
The ion reading module functions in parallel, together with the biochemical
determinations.
If the determining of ions is programmed in the patient programming list, the
sample dispensing arm is responsible for supplying the sample to the ion module.
Then the module determines the concentration of the ions and sends the results
to the programme.
The ion module requires a two-point calibration to function correctly. The cali-
bration is performed automatically whenever a sample with ISE has to be run
and the calibration is already expired. The expiring of the calibration is every 4h.
Nevertheless, the program is informing once the calibration expires.

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In addition, for each determination the module measures one of the two liquids
from the reagent kit: A for determinations in serum and plasma, and B for deter-
minations in urine.
Both liquid A and liquid B are supplied with the reagent kit. That kit is connected
directly to the ISE module.
The kit is supplied as an accessory and its housing is accessible through the front
door of the analyser.

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9. Description of the software

9.1. Identification of the programme parts

Figure 37 shows the main areas of the programme. These parts are common for
the whole programme and are always visible.
1

1 – Menu bar 4 – Action buttons

2 – LIS connection buttons 5 – Main window
3 – Fast access buttons 6 – Information bar

Figure 37 Screen format

))See Software installation in the installation manual

Menu bar This gives access to the programme menus.
Fast access buttons Buttons providing fast access to the different menus.
Action buttons Analyser operation action buttons.
Main window Main zone where the work area is shown.
Information bar Program zone that displays the informative and error messages. It also indicates
the analyser states: SLEEPING, WARM-UP, STAND-BY, RUNNING, PAUSE

9.1.1. List of most frequently-used buttons

Table 2 shows the main buttons which appear frequently in the programme and
their meanings.

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Icon Name Description

New Allows an element to be created: test, calibrator,
control, user, etc.
Edit Allows an already-created element to be edited.

Delete Eliminates an element.

Print Prints information about the element or elements

selected.
Copy Copies the selected element.

Save Saves the data.

Undo Undoes the latest changes and retrieves the previous

information on the element being edited.
Accept Accepts the changes and closes the window.

Close Cancels and closes the window.

Table 2 Description of the most frequently-used buttons

9.1.2. List of fast access buttons

The buttons on the horizontal bar are buttons that give direct access to the main
programme menus. Table 3 contains a description of each of the buttons.

Icon Description of the icon

Access to the general setup.

Access to the test programme.

Access to the profiles programme.

Access to creaction of work sessions.

Access to the positioning of samples and reagents.

Access to the monitor screen.

Access to the results screen.

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 Icon Description of the icon
Access to the quality control screen.

Access to the cumulative quality control screen.

Access to the screen where information is generated for the technical

service.
Access to the information about additional functionality available in
certain screens.
Execution of the work session reset.

Table 3 Description of fast access buttons

9.1.3. List of buttons related to LIS communication

Buttons which appear on the horizontal bar and indicate the main actions that
can be performed with a LIS application and the communications status with LIS
))See chapter 17 for details about LIS communications operation.

Icon Name Description

LIS state LIS connection off.
LIS state LIS connection established and operating.

LIS state LIS connection established but the LIS does

not respond correctly to other actions.
To solve it: check the physical connection,
check that the low level LIS communication
protocol is correct, check the LIS operation
(response times, sending of messages in
correct format, correct message flow, etc.).
LIS state LIS connection established and operating,
but the messages are delivered with delays
and the message queue may be saturated
(check LIS operation).
Query All Button for making a request to all pending
LIS computers.
))
See chapter 17.2
Query by specimen Button that opens the auxiliary screen for
requesting orders by specimen (sample
tube position in sample rotor with barcode
identifier).
))
See chapter 10.5.3

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User manual

Icon Name Description

Add orders Button that is activated when orders are
Download Orders received from the LIS which must be added
to the work session.
))
See chapter 17.2

Table 4 Description of the LIS communication buttons

9.1.4. List of action buttons

List of buttons that execute actions in the analyser. Only the appropriate buttons
for the action being performed by the analyser are activated at any given time.

Icon Name Description

Connect Button for connecting the programme with
the analyser.
Initialise analyser Button for initialising the analyser.

Shut down Button for stopping and shutting down the

analyser.
Confirmation of Button confirming the washing solution
change in bottle bottle has been changed or for cancelling
the high contamination waste bottle alarm.
Recover the analyser Button for recovering the analyser after an
accidental stoppage.
Cancel acoustic alarm Button for cancelling the acoustic alarm; that
button is activated when an alarm appears.
Start session Button for initiating the work session. It can
also be used to restart the work session after
a pause.
Pause session Button for executing a pause in the work
session. It only appears when the session has
been started. The Start Session button turns
to Pause button when the analyzer is in
Running mode.
Abort session Button for aborting or stopping the work
session without being able to continue.
Recommended only when the user does not
wish to continue the session or if there are
problems that make it impossible to execute
it.

Table 5 Description of action buttons

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10. Working procedure

10.1. Starting up the program

To start up the programme, double click on the icon located on the desktop.
On initiating the programme a welcome screen will appear and then the user
identification screen (enter your login and password).

Figure 38 Home screen

The first time the programme is started, the login and password to be entered are:

Parameter Value
User name Admin
Password BA200
Table 6 Initial login and password

Click on the icon to change the password. You can only change the user pass-
word that was entered in the home screen. Once you entered for the first time,
the program ask to you to change the password.
Figure 39 shows the screen for changing the password. Enter the different values
required to change the password.

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Figure 39 Screen for changing the password

10.2. Configuration
In this menu you can access the different setup options:
• General: General programme configuration.
• Languages: Selection of the programme language.
• Reports: Setup of the report headers and page footers.
• Order Printing of Tests: Selection of the test order for the patient reports.
• Barcode: Barcode setup.
• LIS: LIS communication system setup.
• Mapping for LIS
• Users: Generation of users for accessing the programme.
• Change User: Change in user.

10.2.1. General setup

In this screen you can configure the general programme options.
Press this button to obtain direct access to the general setup options.
Select one of the following tabs:
• Work Session
• Analyser
• Communication Setup

10.2.1.1. General configuration: work session

Figure 40 shows the screen with the different setup options for the work session.

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 Figure 40 Work session setup

Default sample tube type Select the tube that will normally be shown when creating the list of patients. It
may be: tube or sample well.
Automatic checking barcodes Check this option is you want the analyser to automatically check the position
of the reagent bottles and sample tubes with the barcode before starting the
session.
Download only patient tubes Check this option if you only want to delete the sample rotor tubes when reset-
from rotor when resetting ting the session. The information and position of the sample wells (calibrators
worksession and controls) will be saved for the next session.
Automatic processing of Check this option if you want the repetitions to be made automatically. If not,
repetitions they can must be made manually.
Automatic printing of patient Check this option to automatically print out the results for a finalised pa-
results tient. When this option is selected the report and frequency type options are
activated.
Type Select the type of report to be used for printing out the patient results.
• Compact - Report with no patient header and with the results of all the patients
in a continuous list with no page separations.
• Individual - Individual report by patient. Each report is printed out on separate
pages with a patient header.
Frequency Select the frequency to be used for printing the results.
• On restarting the work session
• After completing each session
• After completing each patient

10.2.1.2. General configuration: analyzer options

Figure 41 shows the analyser configuration screen.

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User manual

Figure 41 Analyzer options setup

Water inlet selection Select the water inlet mode for the analyser.
The water may enter through different channels which are mutually exclusive:
• Water tank
• Water mains
))See chapter 4.4 for the purified water installation.
Alarm sound disabled Check this option if you do not want the beeper sound whenever an alarm is
indicated.

10.2.1.3. General configuraion: Communications options

Figure 42 shows the communication settings screen.

Figure 42 Communication settings

Automatic Select this option and the programme will automatically search for the compu-
ter output port for communicating with the analyser.
Manual Select this option for the port to be selected manually.
Port:
• Select the available COM port, the USB uses a virtual COM port.

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 If no value appears in the port pop-up menu, wait a few minutes and try the
connection again. The USB driver registration process may take a few minutes.
NOTE

10.2.1.4. General configuration: Test Visibility

In  Figure 43 the screen to configure the visibility of the techniques is shown.
There is a list of all available techniques, the user selects by means of a tick only
those techniques that he wants to visualize in the programming screens, of calcu-
lated techniques and profiles

Figure 43 Configuration of the test visibility

Protected mode Select this mode when you do not want the supervisor and operator user to be
able to modify and display the main parameters of the test. This option will not
be visible to the supervisor or operator users.

10.2.2. Language
This allows you to select the application language.

Figure 44 Screen for selecting the application language.

10.2.3. Reports
This permits the configuration of the patient report format. It allows you to change
the header, footer and add logos.

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Figure 45 Patient report setup screen

There are two default design types, vertical and horizontal.

You can create as many reports as you like. When creating a report, enter the name
and select the format type: horizontal or vertical.
Default template Check this box for the programme to apply the report selected from the list.
There is only one horizontal report and one vertical report with this option
selected.
Press this button to change to the editing mode. You will enter a screen that
allows you to change the format of the header or footer of a page. You can also
enter text, graphic elements and icons.

10.2.4. Arrangement of tests for report

This allows you to define the order in which the tests will appear in the patient
report.
In this screen you can select the order of the tests, calculated tests and external
tests. When the patient report is drafted, the order of the tests that appears is the
one selected.

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 Figure 46 Screen for arranging the tests

Select a test or test group and press one of the buttons until the test is placed in
the desired position. Normal arrows orders the selected test by one step posi-
tion, while arrows aiming to an horizontal bar orders it at the beginning (aim-
ing up)/end (aiming down) of the list
Press this button to display the tests in alphabetical order again.

10.2.5. Barcode
Screen for configuring the barcode reader options. Figure 40 shows the screen with
different options that allows the configuration can be made.
Disable Barcode Select this option to disable the barcode reader. Disabling the barcode reader is
incompatible with either LIS connectivity or sample ID by labelling.

Sample barcode type Select the barcode type for performing the sample barcode readings. More than
one barcode type can be selected. The barcode printed on the labels of the pri-
mary tubes must coincide with the code selected in the configuration.
Barcode fields activation If this field is not activated the barcode reader identifies the whole barcode as
the sample identifier and the reader can read any code with length of between
1 and 30 characters. Codes with different lengths can be combined in the same
session.

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When this field is activated, information on the sample type is provided in addi-
tion to the sample identifier. The total size of the barcode is still flexible, between
1 and 30. The following fields are enabled too.
Start and end Select the start and end positions of the sample identifier in the barcode. The
sample type will always be shorter in length than the total barcode length.
Sample type Specific characters which define sample type within the barcode. The number of
characters must match with total length for sample type identifier. Every code
identifies one sample type.

Figure 47 Barcode reader setup

10.2.6. LIS configuration

Screens that allow the setup of the parameters of the LIS application which the
communication is to be made. These parameters can only be changed when the
analyser is in the STAND-BY mode.

10.2.6.1. Work session setup

Screen showing the setup options with LIS communications that affect the work
session.
Figure 48 shows the LIS configuration screen.
Host Query This allows this work mode to be activated or deactivated. The Host Query
mode allows to operate automatically by ask and response through the LIS-
analyzer communications.
Rerun working mode It allows you to select who has permission to perform the repetitions: LIS, the
(repetitions) analyser or both.
Automatic query to LIS(before When this option is activated the Host Query process can be automated using
starting/continuing the work the session start button. It is normally active when the LIS is connected and
session) available.
Maximum time waiting for LIS Maximum LIS response waiting time. This value should be adjusted depending
orders on the response speed of each LIS, the communication speed of each laboratory

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 and the packet size of each query message. It is configured in the option Host
Query Packages size.
Upload patients results When this option is activated the patient results created manually through the
requested from the analyzer analyser are sent.

Upload QC results When this option is activated the results of controls requested manually
requested from analyzer through the analyser are sent.

Upload results during When this option is activated all the results of the session following a reset are
Reset worksession sent. All the results requested by the LIS will be sent and when the above pa-
rameters are active, the results requested manually from the BA200 will also be
sent.
Automatic results upload When this option is activated you can select the frequency with which the
results are automatically sent to the LIS.

Type of on-line export Description

On completing every At the end of a work session all the results are
worksession exported from the patient list.
On completing every On completing each patient the results for
patient that patient are automatically exported.
On finish every patient On completing a test on a patient the results
test are automatically exported.

Figure 48 LIS options setup

10.2.6.2. Communication settings

Screen for configuring communications with a LIS system.

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LIS communications enabled This allows communication with a LIS application to be activated or
deactivated.
Data transmission type The transmission may be:
• ASTM: TCPIP-Client, TCPIP-Server
• HL7: TCPIP-Client, TCPIP-Server, TCPIP-transitory connection
Host name This field is only completed when the data transmission type option has been
selected: TCPIP-Client. Enter the IP of the computer IP when the LIS for mak-
ing the connection is executed.
TCP port Number of the TCP-IP port through which the LIS connection is made.
When the TCPIP-Transitory HL7 Connection is selected, 2 different ports must
be configured: client port and server port.
Client TCP port Number of client port in a TCP connection.
Server TCP port Number of server port in a TCP connection.

Figure 49 LIS communication settings

10.2.6.3. Protocol
Screen for configuring the necessary parameters for the low level LIS communica-
tion protocols.
Protocol name Select the type of protocol to be used in the communications: HL7 or ASTM.
Transmissions code page Select the type of coding for messages to be sent between the analyser and the
LIS. This is used in transmitting and receiving messages. You should configure
the page code used by your LIS system.
Host ID Identifier used by the LIS application.
Host provider Name of the LIS application supplier.
Instrument ID Name used to identify the instrument; that field is transited in each message.

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 Analyzer provider Name of the instrument supplier.
IHE compliant Select this option when the message transmission strictly follows the IHE com-
munication standard.
Host Query packages size Number of specimens sent in one Query message by specimen when using the
ASTM protocol.
Max time to retry sending Configuration of the maximum time during which another attempt is made to
messages to LIS send a message to LIS when no response is received.
Max time to consider LIS Configuration of the maximum wait time for receiving an acceptance or con-
offline firmation message from the LIS. After this time the LIS state is modified (Led
lamp on red) indicating that there are problems in communication which must
be solved.
Delimiters Enter the delimiters to be used in transmitting and receiving messages.

Figure 50 LIS protocol setup

10.2.7. LIS mapping

Screen for configuring the names to be used in LIS requests.
The names of the following elements should be configured: tests, ISE tests, calcu-
lated tests, external tests, sample types and units.
Caution: LIS requests with test names, sample types or units that have not been
entered in this screen will be rejected by the analyser.
The screen shows a table with different columns:
• The first column shows the type of element, which may be any of the follow-
ing types:
• Calculated test
• Standard test
• ISE test
• Units
• Sample type
• External test

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• The second column shows the name of the element as it appears in the analyser.
• The third column shows the name of the element used in communications
with the LIS (messages received and sent). These names must be edited in
order to adapt them to each LIS. When installed, the same names as those
used in the analyser will appear.
LIS mapping types Selection box for filtering the elements shown by each of the types.
You are able to edit any LIS Name by pressing the edition button, and saving it.

Figure 51 LIS mapping configuration screen

10.2.8. Users
This allows you to create, edit and delete the names of the users accessing the
application.
There are three user levels. Administrator, supervisor and operator.

Level Description
Administrator Has complete access to the application. This user is allowed
to create the supervisor and/or operator user. There is only
one administrator user.
From this level of permissions you access the configuration
screen of the test visualization. The supervisor and operator
users do not have access to this screen.

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 Level Description
Supervisor Has limited access. This user is allowed to create users with
operator permits. He is permitted to change the calibrators
and control values and create a limited number of tests
established by the Administrator. Only one supervisor
can be created. Supervisor is able to create up to 5 new
additional tests.
Operator This is the most restrictive access level. This user can only
execute lists, view and print out results and consult the test
parameters. As many users as required can be created.
Table 7 User levels

Figure 52 User creation screen.

Figure 52 shows the screen for creating and maintaining users.

Click on the icon to obtain access to creation of new users. The boxes for enter-
ing the user data are activated.
User ID Enter a name for identifying the user in the application.
Level Enter the level for that user: supervisor or operator. The supervisor level can
only be created if the application has been accessed by an administrator user.
Given name User name.
Last name User surname.
Password Enter a password.
Password confirmation Enter the same password again to ensure it was entered correctly.

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10.2.9. Change user

This screen allows you to change a user in the application without having to exit
and then re-enter.

10.3. Programming
In this menu you can access the different options for programming the necessary
parameters to measure with the analyser. The different programming options are:
test, calculated test, contaminations, profiles, calibrators, controls, patient data,
ISE tests and external tests.

10.3.1. Tests
Check the test parameter programme is according to the instructions for use
(IFU) for each reagent.
CAUTION This option in the programme allows you to create, change, delete and list the
tests and their parameters.

Figure 53 Test creation screen

The screen is divided into two parts. The left-hand part shows a list of all the
tests and the right-hand part shows the different parameters and their values. The
parameters are grouped by different sections: general, procedure, calibration and
blank, quality control and options.
Press on the name of the section to access each group of parameters.
Press the icon to create a new test. To indicate that the fields can be edited, the
background colour will change to white. Some parameters will appear with
default values.

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 To edit the parameters of a test already entered, first select the name of the test
to be changed from the test list and then press the icon. You can also edit the
test parameters by double-clicking on the name of the test in the list of tests.
Select the test name and press the icon. The programme will ask for confirma-
tion before deleting it. Only the tests created by the user can be deleted (the test
icon is in yellow). The original tests (with the blue icon) cannot be deleted.
Press the icon to open up an auxiliary screen which allows you to clear and
order tests. The ordering and/or clearing of tests is applied in the test selection
screen.
))See chapter 10.3.1.1
Press this icon to make a copy of a test. The name of the new test must be
changed.
You can delete or print out several tests at once, and make multiple selections
from the list of tests.
Non-consecutive multiple selection Select a test and keep the CONTROL key pressed while you select the other
tests.
Consecutive multiple selection To make a consecutive multiple selection of several tests, select the initial test,
press the UPPER CASE key and selec the last test. All the tests between the ini-
tial and last test will be selected.
Ordering of tests Press the header on the test list to show the tests in ascending order. If you press
a second time, they will be shown in descending order.
This icon will appear when a compulsory parameter needs to be entered, or if
there is an error in entering the value.

10.3.1.1. Ordering of tests

This screen allows you to order the tests in the test selection screen when creating
the worklist.

Figure 54 Screen for ordering the tests

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Select a test or test group and press one of the buttons until the test is placed in
the desired position.
Press this button to display the tests in alphabetical order again.

Check the box whenever a test should be available in the Selection Test screen.
Uncheck it if you are not going to work with.

10.3.1.2. Test parameters: general

Name Test name. This name is used to identify the test in the programme. The maxi-
mum length is 16 characters. Do not change the name of the test.
Short name Abbreviation of the test name. It must have no more than 8 characters. This
field is used in the parts of the program where there is insufficient space to show
the full name.
Sample type Select the type of sample, which may be:

Sample type Description

SER Serum
URI Urine
PLM Plasma
WBL Whole blood
CSF Cerebrospinal liquid
SEM Semen
LIQ Biological fluid

In creating a test, select the type of sample to which it is applied.

You can create a test with different types of sample. Display the sample type op-
tions and check the type you want to add in the options table.
In a test with more than one sample type, you can enter different test parameters
for each sample type.
This icon appears when a test is programmed with several sample types.
Analysis mode The absorbance calculation depends on the analysis mode selected.
The analysis modes may be:

Analysis modes
Endpoint monoreagent
Endpoint bi-reagent
Differential be-reagent
Fixed time monoreagent
Fixed time bi-reagent
Kinetic monoreagent
Kinetic bireagent

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 ))See how to make the absorbance calculations depending on the analysis mode in chapter 16.
Unit Select from the list the unit that will use the test. This value will be displayed
along with the concentration results.
Decimals Number of decimal points for displaying the concentration values.
Number of replicates Number of replicates performed by the analyser for each sample.
Type of reaction Select the type of reaction: increasing or decreasing.
Report name Name of the test which will appear in the patient report. If there is no name
entered in this box, the test name will be shown in the patient report.

10.3.1.3. Test parameters: procedure

Figure 55 Test parameters, procedure screen

Reading mode Select one of the two following options: monochromatic or bichromatic. The
absorbance calculation depends on the reading mode.
))See how to perform the absorbance calculations in chapter 16.
Main filter Select the main filter value to be used for taking the readings.
Reference filter Select the reference filter value. This box will only be activated if the bichro-
matic reading mode has been selected.
Sample volume Enter the sample volume for making the preparation. The sample volume range
is from 2 mL to 40 mL. The volume can be entered in decimal fractions in mL.
Volume of reagent 1 Enter the reagent 1 volume for making the preparation. The volume range is
from 90 mL to 300 mL.
Volume of reagent 2 Enter the reagent 2 volume for making the preparation. The volume range is
from 10 mL to 100 mL. This box will only be activated if the bi-reagent option
is selected in the analysis mode.

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Reading time 1 Enter the reading time for calculating the absorbance. This can be entered as
seconds or cycles. The time range is from cycle 2 to 35 when the reaction is in
monoreagent mode or from cycle 2 to 18 when the reaction is in bireagent.
Reading time 2 Enter the time for making the last reading. This box will be activated for kinet-
ic, fixed-time or bireagent differential calculation methods. The time ranges are
from cycle 3 to 35. Reading time 2 must always be greater than reading time 1.
Diluent Select the diluent for preparing the dilution. It may be distilled water, saline
solution or a generic diluent. This bottle will be used for pre-dilutions and for
performing repetitions and it must be installed on the reagent rotor.
Pre-dilution factor Activate this option if the sample requires a pre-dilution. The pre-dilution can
be made automatically by the analyser or manually, which it requires the user’s
intervention. Its final result will be calculated automatically taking into account
the applied dilution ratio. This function affects all the samples. The parameters
required are:

Pre-dilution parameter Description

Analyser/user Select who you want to make the pre-
dilution: the analyser automatically or the user
manually.
Factor Enter the pre-dilution factor. The range to be
entered is from 2 to 200.
Same dilution for controls Activate this option if you also want the
control to be diluted in exactly the same way
as the sample

Automatic repetition Activate this option if you want automatic repetitions to be made whenever a
result is out of any established limit in Options screen tab. This function affects
only individual test and it is in dependency of the ‘Automatic processing of
repetitions’ function. See General Setup configuration 10.2.1
Post-dilution factor Enter the reduced and increased factor. When performing automatic repeti-
tions, make the preparations using these post-dilution ratios. Manual repetitions
show these values by default, but they also allow the user to enter a different
dilution factor before sending them.

Repetition factor Description

Reduced factor This will be used when a preparation is to
be made with a diluted sample to obtain
concentration results within the linearity limit.
Enter the factor for the repetition
concentration to be reduced without exceeding
the linearity limit. A value between 2 and
200 can be entered. The analyser will make
a prior preparation to dilute the sample in
the reaction rotor. The result of the diluted
preparation will automatically be multiplied
by the factor.

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 Repetition factor Description
Increased factor This will be used when making a preparation
with a higher sample proportion (to
solve problems of samples with very low
concentrations that are below the detection
limit)
Enter the factor for the repetition
concentration to be increased and exceed
the detection limit. The analyser changes
the sample/reagent volume ratio with
the programmed factor. The result of the
preparation will automatically be divided by
the factor.

10.3.1.4. Test parameters: calibration and blank

Blank type The blank can be made in different ways. Select the method for making the
blank:

Type of blank Description

The analyser makes the blank with purified
Blank with Distilled Water
water.
The analyser makes the blank with
Blank with Saline Solution
physiological saline solution.
The analyser makes the blank only with the
Blank only with reagent
reagent

Figure 56 Test parameters, calibration and blanks screen

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Blank replicates Number of replicates for making the blank. The range is from 1 to 3. The mean
of the replicates is used to calculate the concentration.
Factor If the test is not calibrated enter the multiplicative factor value for calculating
the concentration.
Experimental calibrator Enter the calibrator data and its concentration. Press the icon again to open up
the calibration screen and enter the calibrator parameters.
))See how to enter the calibrator parameters in chapter 10.3.5
Calibrator replicates Number of replicates for making the calibrator. The range is from 1 to 3. The
mean of the replicates is used to calculate the factor.
Use alternative calibrator Calibration reference it will be used for another sample type (i.e. you can use
calibration data obtained from SER type to be applied on URI type)
Calibration and curves values Shows the calibrator values assigned to the test. They are only shown for in-
formative purposes. To create new calibrators and/or change them, edit them in
the calibrator screen.

10.3.1.5. Test parameters: quality control

Figure 57 Test parameters, quality control

Activate quality control Check this option to activate the quality control for this test. If this option has
not checked, the selection of the test in the Controls Programming screen will
not available.
Control replicates Number of replicates for measuring the controls. The range is between 1 and 3.
Rejection criteria It establishes the limit considered as an alarm. This value is calculated in stand-
ard deviations (SD). The margin is between 0.1 and 4.1.

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 Calculation mode The calculation mode may be manual or statistical. Indicate how to calculate the
ranges in order to draw the Levy-Jennings graph and activate the Westgard rules
alarms.

Calculation Description
mode
Manual Use the theoretical ranges of the serum control seating values
entered when registering a control. They remain unaltered,
unless new cumulative values are to be assigned. Lot Average
and SD values have been obtained experimentally from
different instruments.
))
See chapter 10.8.3
Statistical Use the ranges calculated from the mean and SD of the above
series.
The minimum number of series indicates how many values
will be used to calculate the expected average and SD. During
these first series, the manual mode is used internally. The
minimum number of series to be programmed is 5. After the
internal series, the obtained average and SD results will be
compared against the expected.
Different quality regulations in the laboratory make it
advisable to assign 20 minimum series when starting to use a
specific control lot.

Rules to apply Select which Westgard rules you want to apply to the quality controls for this
test.
It serves to register the controls with their batch and concentration values.
))See how to register a control in chapter 10.3.6.
Control selection This table shows the different controls registered for the test. In the box, activate
the controls to be used, as you may have created various controls. It can activate
up to 3 controls at one time.

10.3.1.6. Test parameters: options

Screen where the limit values are programmed for issuing warnings and alarms to
the user, depending on the results.

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Figure 58 Test parameters, options screen

Blank absorbance limit Limit value established for comparing against the result of the blank absorb-
ance. It is used for checking the state of the reagent.
Kinetic blank limit Enter the correct kinetic blank value limit. It is only applied to tests with the
kinetic calculation mode.
Linearity limit Enter the value for which the reagent is no longer linear. If the concentration
value is higher than this value, the programme will issue a warning message and
if it is activated in the programme a repetition will automatically be launched.
Only linear calibrations have pre programmed values for this. In case of multi
point calibrations, which they may depend on lot experimental values, this cor-
responds to the highest concentration value.
Detection limit Enter the value for which the reagent does not detect a value. If the concentra-
tion value is lower than this value, the programme will issue a warning mes-
sage and if it is activated in the programme a repetition will automatically be
launched.
Factor limits Upper and lower range for verifying that the calibration factor is correct.
Repetition range The analyser repeats the sample automatically if both the concentration value is
within the range and the automatic repetition is enabled. This range serves to
confirm the result automatically.
Prozone effect The prozone effect may occur in tests based on the principle of the formation
of antigen-antibody complexes (agglutination). This effect is usually detected in
samples with a high antigen content. Excess antigen inverts the reaction direc-
tion and may cause incorrect sample measurements. To detect that effect you
should activate the prozone effect option and enter the 3 parameters: Time 1,
Time 2 and ratio in (%).
The program will calculate the absorbance increases in times 1 and 2, obtain the
increase quotient and compare the result against the ratio. If the quotient exceed

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 the ratio, an alarm is triggered indicating that the sample could have the prozone
effect, in which case the user must make a manual repetition with a dilution factor,
to finally determine the exact value of the sample.
The prozone effect verification parameters must be determined by the end user.
In the case of doubt in detecting the prozone, the user must make a sample
dilution, to ensure the result is correct.
CAUTION
Slope function Enter parameters a and b of the formula Y=aX+b. These parameters change
the value of the result concentration in a linear manner. This option serves
to proportionally correct the concentration of a sample for the same absorb-
ance. Where X will be replaced by the concentration value and Y will be the
changed concentration value. a and b are the slope and the intercept with Y axis
respectively.
Substrate depletion Enter the value in absorbances. When a test in kinetic analyse mode has a point
below this limit, this means it has consumed the reagent substrate, and the re-
sult is thus not correct. When this alarm is activated the programme automati-
cally launches a repetition.
Reference ranges Indicate the normal reference values for the population. If values are entered in
the fields, the results are shown on the screen along with the patient report and
the concentration result.

Reference range Description

Generic A series of common ranges for the whole population is
entered in these fields.
Detailed In this table the specified ranges are entered by gender
and/or by age.
Enter the gender, age group and normal values in each
row.

Panic ranges Enter the values for which a result is pathological. The values entered must meet
the following conditions:
Minimum panic < Minimum normality < Maximum normality < Maximum panic

10.3.2. Calculated tests

Screen in which the calculated tests are programmed. The result of the calculated
tests is obtained by applying a formula with the concentrations of several standard
tests, external or fixed factor values performed previously.

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Figure 59 Screen for creating calculated tests

On the left-hand side of the screen is a list of calculated tests and on the right-hand
side are the parameters to be entered for each calculated test.
))See how to create, edit, delete and print icons in chapter 10.3.1.
Name Name of the calculated test.
Short name Abbreviated name of the calculated test.
Sample type Indicates the type of sample to be used for selecting the standard tests.

Sample type Description

Single In this option the standard tests have only one type of
sample.
Multiple In this option the standard tests may have different
sample types.

Unit Unit in which the results of the calculated tests will be shown. This unit may be
different from that of the standard tests.
Decimals Number of decimal points for displaying the calculated test concentration val-
ues. This number of decimal places may be different from that of the standard
tests.
Print experimental tests Check this option if the patient report also has to show the results of the stand-
ard tests in addition to the result of the calculated test.
Formula definition Formula relating the calculated test to the standard tests. To enter the formula,
select the standard tests, other calculated tests, numbers and operators. The
programme verifies whether the formula entered is correct and indicates this
through one of the following icons:

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 This icon indicates that the formula has been correctly entered with no errors.
This icon indicates that there are errors in the formula. Change the formula
until the icon disappears.
Delete the last character entered.
Delete the whole formula entered.
A reference range screen tab is also available to enter the expected values in Generic
or Detailed manner.
))See how to create, edit, delete and print icons in chapter 10.3.1.

10.3.3. Contaminations
When contamination exists between programmed reagents, analyzer throughput
drops.
CAUTION This screen is used to program contaminations between reagents and cuvette
contaminations.
To eliminate the contamination, first of all the programme orders the tests for a
patient to avoid dispensing them in consecutive order. If it is not possible to elimi-
nate the contamination by ordering them, an extra wash cycle is added between the
contaminant test and the contaminated test, to clean the tip. If nothing is indicated
in the programme, the wash cycle is performed with purified water, otherwise the
cycle will be executed with the programmed washing solution.
It exists up to 3 different washing solutions. washing wolution 1 corresponds to the
acid washing solution (AC17201), washing solution 2 corresponds to the alkaline
washing solution (AC17205). You can define one more washing solution, WS3.

Figure 60 Contamination programming screen

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In the left-hand column a list of all the potential contaminant tests is displayed.
The tests for which contamination has already been programmed are marked in red.
Select a test and then press any of the following icons:
Press this icon to add the contaminated tests to the selected test. The contami-
nated test table will be activated for you to select the contaminated tests. The
washing solution to be used by the analyser to prevent contamination can be
indicated for each contaminated test.
Contaminated well Select this box if the contaminant test contaminates the reaction rotor cuvette.
Step 1 Enter the washing solution to be dispensed in the reaction cuvette if the con-
taminant is reagent 1.
Step 2 Enter the washing solution to be dispensed in the reaction cuvette if the con-
taminant is reagent 2.

Eliminate the contaminated test and cuvette programming.

Press this icon to print out a list of all the contamination pairs.
When this icon is pressed an auxiliary window emerges with a summary of all
the contamination pairs and all the tests contaminating the reaction cuvettes.
))See Figure 61
The first column shows the contaminant tests, the second one shows the con-
taminated test and the third column shows the programmed washing solution. To
review the programmed contaminations, you can order the tests in alphabetical
order based on the contaminant tests column or the contaminated test columns.
To do this press the header of either column. If you press twice, they will first be
shown in ascending order and then in descending order.

Figure 61 Contamination summary screen

In the cuvette section, the contaminant test is shown, with the washing solutions
to be used in step 1 and step 2.

10.3.4. Profiles
Profiles are names given to a set of tests with a diagnostic significance. Profiles are
sets of tests that are usually requested at the same time.

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 Figure 62 Screen for entering profile information

))See how to create icons, edition, deletion and printing of the test screen in chapter 10.3.1.
Parameters to be programmed in the profiles:
Name Profile name.
Sample type Select the type of sample the profile will have.
Test type Select the type of test, which may be: standard, calculated, ISE or external tests.
It serves to filter the number of tests to be displayed in the selection column.
Select the different tests you want to form part of the profile. Use the CTRL and
BLOCK CAPITALS keys to make a multiple selection.
Add the selected tests to the profile.
Eliminate a test from the profile.
Add all the test at one time to the profile.
Eliminate all the tests at one time from the profile.

10.3.5. Calibrators
Check the calibrator concentration values entered against those of the instruc-
tions for use (IFU) values of the calibration serum. Make sure you enter the
values with the test programme units.
CAUTION
Screen for programming the different calibrator parameters: name, batch, expiry
date, concentration, number of calibrators.

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Figure 63 Entering the calibrator information

Figure 64 Entering the calibrator concentrations

In the first tab it is entered the general information on the calibrator. Calibrators
for all the pre programmed tests are already programmed but you can create new
ones, edit or print with the corresponding icons.
The information to be entered by the user is the following:
Calibrator name Enter a name for the calibrator. If you don’t change its name, you can leave the
default ID

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 Lot Enter the calibrator batch. When the lot is changed, you must reprogramme the
concentrations of all the tests that use this calibrator. The programme issues a
warning, showing the tests affected.
Expiry Enter the days the calibrator will last once reconstituted.
No. Enter the number of calibrators.
Dilution mode Visible only when the standard number is greater than one. Select the dilution
mode: manual or automatic. In automatic multipoint calibrations, it is the
analyzer that automatically prepares dilutions for each point from the highest
concentration standard. In the manual option there are as many calibrators
prepared as points are defined in the curve.
In the second tab the calibrator is assigned to the test and the concentration value
is entered.
First select the test to which you want to assign the calibrator and then press the
edit button.
Calibrators Select the name of the calibrator you want to assign to the test.
Enter the calibrator values for the test.
If the calibrator is for a specific value, you only need to enter the concentration
value. In multipoint calibrators, you must enter the following parameters:
Increasing / decreasing This indicates whether the calibration curve will be ascending or descending.
Creating the curve Enter the method for creating the calibration curve. It may be one of the fol-
lowing methods: polygonal, linear regression, parabolic regression or spline.
Also select the axes on which you want to show the calibration curve: linear axes
or logarithmic axes.
Concentration values Enter the concentration values for each standard in descending order.
Diluent Choose the diluent to perform the automatic curve.
Max. concentration Enter the highest standard concentration.
Factor Enter each dilution factors for each point in decreasing order. It is important
to introduce the number one at the first point to indicate which is the highest
standard.
Ask for the test calibration programming in the test programming screen. You
can only change the calibration value in this screen.

10.3.6. Controls
In this screen the controls to be used are registered. You can create new controls
and edit, delete and print them.
You can also edit the minimum and maximum values of each test for each control
level.
Control name Enter the control name.
Sample type Enter the type of sample that will use this control.
Level Enter the control level (1, 2 or 3). This is used to facilitate the selection of an
entire level in the sample request screen.

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Lot number Enter the batch number of this control.

Press this icon to register a new control lot. It also allows you to retrieve the data
of the last lot memorised after changing the lot. Every time you change the lot
the quality control values will accumulate.
))See Figure 66
Activation date The date on which the control is first used. This field is not editable and, by
default, it acquires the value of the current date.
Expiry Enter the expiry date. The program issues a warning when a control whose
expiry date has been exceeded its used. Usually, the expiry date corresponds to
the less stability parameter included in the control (in case of multiparametric
controls) and it will depend on the conservation method of the control (freez-
ing, etc.)
Tests Press this button to assign or eliminate the tests associated to a control level.
It appears an auxiliary screen that contains only the tests for the same sample
type, with the quality control activated (when created, the tests normally have a
deactivated quality control).
When you enter the QC assigned range, automatically the program calculates
its average and the value of 1 SD, which it depends on the Rejection criteria pre
defined (see 10.3.1.5)
))See Chapter 10.3.1.5 to activate Quality Control

Figure 65 Screen for programming the control serums

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 Figure 66 Screen for changing the lot of a control

10.3.7. Patient data

Screen for entering the patient data: patient code, name, gender, etc. After entering
the data, a report for each patient can be generated with the analyte concentration
results. Having the patient data entered makes it easier to organise and search in
the historical log. In this way the results for one patient obtained during different
periods can be grouped together.

Figure 67 Screen for programming the patient data

At the top of the screen is a list with all the patients already entered.
))See how to create, edit, delete and print icons in chapter 10.3.1.
Patient ID Enter a patient identifier in order to associate the patient data to the results.
Gievn name Enter the name of the patient.
Last name Enter the surname of the patient.

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Gender Enter the gender of the patient: male or female.

Date of birth Enter the date of birth of the patient. The age field is calculated automatically
after entering and saving the date.
Performed by Enter the name of the doctor.
Remarks Field blank for entering the opportune text.
Press this icon to make a search for a specific patient in the patient list. When
the icon is pressed an auxiliary screen will appear for you to select the search
field.
))See Figure 68 for more information.
Press this icon to cancel the search options and view all the patients.

Figure 68 Screen for selecting the search options.

Complete one or more fields to enter the search criteria. For the date of birth and
age fields you must enter a range of dates and ages respectively.
Press this icon to make a search after entering the criteria.

Press this icon to delete all the search criteria. It is activated when data is entered
in any field.

10.3.8. ISE test

Screen for programming the ISEmodule parameters. The ion-measuring module
is optional. The module can measure 4 different ions: Na+, K+, Cl- and Li+, which
are already programmed by default. No new ones can be created and they cannot
be deleted. Supervisor user can change the following parameters:

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 Name Test name. This name is used to identify the test in the programme. The maxi-
mum length is 16 characters. Do not change this field content.
Short name Abbreviated name with up to 8 characters for use in certain screens in the
application.
Sample type Select the type of sample to be used. Tests which the blue symbol (plus) appears
they have more than one programming available in sample type dependency.
Available ISE test Select this option to view the lithium test on the sample selection screen (option
only available for Li+).
Report name Name of the test which will appear in the patient report. If there is no name
entered in this box, the test name will be shown in the patient report.

Figure 69 Screen for programming the ISE parameters

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Figure 70 Screen for programming the ISE parameters

Decimal Number of decimal points for displaying the concentration values.

Unit Select from the list the unit that will use the test. This value will be displayed
along with the concentration results.
Slope function Enter parameters a and b of the formula Y=aX+b. These parameters change
the value of the result concentration in a linear manner. This option is used to
modify in a constant way all the sample results.. Where X will be replaced by
the concentration value and Y will be the changed concentration value. a cor-
responds to the slope of the calibration, whereas b corresponds to the intercept
with Y axis.
Quality control Enter the quality control values.
)) The method for entering the quality control values is set out in chapter 10.3.1.5.
Reference ranges Enter the reference values.
))See how to enter the reference values in chapter 10.3.1.6.

10.3.9. External test

External tests are tests whose result is not measured by the analyser, but which
must appear in the patient's report or in the patient's historical log. When one of
these tests is assigned in the work session the results for those tests can be entered
from the session screen or when viewing the results.
All the information entered in the test may be shown in the patient's report.

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 Figure 71 Screen for programming external tests

Name Enter the name of the external test.

Short name Abbreviation of the test name. It must have no more than 8 characters. This
field is used in the parts of the program where there is insufficient space to show
the full name.
Sample type Enter the type of sample.
Result type Enter whether the result will be: quantitative or qualitative.
Decimal Number of decimal points for displaying the concentration values.
Unit Select from the list the unit that will use the test. This value will be displayed
along with the concentration results.

Type of result Description

Quantitative This is a numerical result. When selecting this option
the units and number of decimals places for the result
are entered.
Qualitative This is a non-numerical result. For example: a positive
or negative result, a high or low result, etc.

Reference ranges Enter the reference values.

))See how to enter the reference values in chapter 10.3.1.6.

10.4. Initialising and switching off the analyser

The process for switching on the analyser is carried out when the main analyser
switch is opened. The analyser performs its internal checks and after a short “beep”

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is launched, the state LED lamp turns orange, indicating that the analyser is ready
to be connected with the user programme.
The user programme is initiated and the communication connections are estab-
lished automatically.
If there is no communication with the analyser, check the communications setup
and press the connect button.
))See chapter 10.2.1
Once connection is established the analyser is connected. In this state the user can
access any part of the programme, except the parts that operate with the analyser
(start worklist, change rotor, etc). Press the initialisation button to operate with it.
The initialisation process is automatic and includes the following steps:
• Process for previously checking the state of the analyser and priming the
fluidic system.
• Wait 20 minutes for the reading rotor temperature to stabilise. Since the
baseline is totally dependant to the rotor to reach the 37ºC temperature, It is
not advisable to terminate the thermo time by pressing the Terminate button.
• Initialisation of the reading rotor baseline. This process consists of filling the
120 rotor wells with distilled water, making the photometric readings with
all the wavelengths in each well and emptying and drying the reading rotor.
The photometric readings will serve to compensate the samples values. The
photometric readings will serve to compensate the readings of the determina-
tions. If any reading is outside pre-established margins, this well is discarded.
If there are more than 10 discarded wells, the program suggests changing the
readings rotor. This whole process takes about 15 minutes.
The switching off process is performed by pressing this button. During the switch
off, the program will ask you to positionate the ISE clenaing solution whenever
the last sessions total number of ISE tests run exceed 50.
))See chapter 14.2.9
Once the washing operation has been completed the analyser will automatically
go off.

10.5. Work session

In this menu you can access the options for creating the work session and position-
ing the samples and reagents.

10.5.1. Sample request

This screen is used to create or import the work session. As the list of patients
is created, the different tests to be executed are assigned. For the first time, the
programme automatically incorporates the blanks and calibrators related to each
test. It also incorporates the controls for the tests that have them programmed.

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 Figure 72 Screen for entering new samples

The screen has two parts. The top part contains the fields for entering the patients
and tests. The patients entered are shown in list format, in the bottom part. Each
individual patient and test can be edited and deleted until the list is positioned on
the rotor. Once a sample is being positioned, you are not able to delete it.
Sample class This field is used to select the type of sample to be entered. The types may be:
patient, blank, calibrator or control. It serves to make only lists of blanks and
calibrators or only lists of controls.
Urgent This is used to indicate that the sample is urgent. Only available for patient type
samples. Urgent patients are the first ones to be executed. If a work session is
interrupted and urgent patients are added, they will be processed as soon as the
instrument finishes the preparations in progress.
Patient/sample Field in which the sample code is entered. This code may be alphanumerical. If
no code is entered, it is generated automatically. The automatic code starts with
the character #, followed by the date in numerical format and a consecutive
number. The selection of a preprogrammed patient implies acquiring the iden-
tification assigned to that patient. Identification of the patient entered manually
corresponds to the same identification as the sample.
Number To enter several patients with the same test profile, enter the number of patients
to be created. If the previous field has data entered, this field will be deactivated.
The patient code is automatically generated and starts with #, to distinguish it
from those entered manually.
Sample type Select the type of sample before going to the test selection screen. Patients with
several sample types will have different tubes, one for each type. (For example:
for a patient with a serum sample and a urine sample, it will place both tubes in
the rotor. Each tube can only be assigned the tests of the sample type selected).
In the event of determining ions in urine, dilute it manually and place the dilu-
tion in a different tube.

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Tests Button for accessing the list of tests and assigning them to the patient. See Fig-
ure 72.

Figure 73 Test selection screen

This screen shows all the tests related to a sample type. The tests are divided into
functional groups: standard tests, calculated tests, ISE tests, external tests and
profiles.
Colour code for the test selection status.

Colour
Name Description
code
Selected Test selected

Deleted Test to be deleted. When accepted, this

test will be eliminated from the work
session along with the related blanks and
calibrators.
Selected for Test already in use. This test cannot be
execution deleted from the work session.
Selec. with different Patient with normal and urgent tests
priority selected.
Control partially Test created with more than one control
selected and elimination of one control after
creating the work session.
Unselected Unselected test

New tests can be added to a work session that has samples and reagents in position.
To do this select the patient for which the tests are to be added and press the tests
button. The programme will ask the user about whether new tests are to be added,
and if the answer is yes, the screen in Figure 72 appears. Samples or tests can also
be added to work sessions that are already initiated or finished.

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After entering the tests for a patient, the information is shown in the list in Figure
71.
The information is separated into two tabs: patient information and information
on blanks/calibrators/controls.
The following information is shown in the patient tab:

Column name Description of the patient tab fields

Selected Each patient added to the session normally appears as
selected. If it is activated, when the position button is
pressed the samples are sent to the positioning screen.
If the selected is cancelled they are not sent and remain
pending. They will not be executed.
Patient/sample This indicates the sample code. This code can be
changed; press code and it will change to the edit mode.
Urgent An icon indicates whether the patient is urgent or
normal:
Normal patient
Urgent patient
(Empty) This indicates whether the test is ISE or external (OFF).
Test Test name.
Type Sample type.
Replicates This indicates the number of replicates of the test to
be made. The number of replicates is usually shown
programmed in the test. The replicates of each sample
can be changed.
Tube This indicates the type of tube when it is to be put in
position. It may be a sample well or a tube. The type of
tube can be changed by selecting it from the pop-up list.
Calculated tests If the test belongs to a calculated test, this field shows the
name of the calculated test.
Formula This field is related to the above. It shows the formula of
the calculated test.
Profile If the test belongs to a profile, this field shows the name
of the profile.

The following information is shown in the blanks/calibrators tab:

Column name Description of the blank/calibrators tab fields

Selected The blanks and calibrators are usually shown selected
when there are no previously-memorised results. The
elements selected are sent to the positioning screen. The
elements not selected are not sent and remain pending
(they are not included in the work session)

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Column name Description of the blank/calibrators tab fields

Class Select the type of information, which may be:
Blank
Calibrator
Calibrator This indicates the name of the calibrator used
Lot This indicates the calibrator lot
No. of Calibrators This indicates the number of calibrators
Test Test name
Type This indicates the sample type
Replicates The number of replicates is usually shown programmed
in the test. The replicates of the blanks and calibrators
can be changed.
Tube This indicates the type of tube when it is to be put in
position. It may be a sample well or a tube. The type of
tube can be changed by selecting it from the pop-up list.
New This indicates whether a new blank or calibrator is to
be made during the work session. It is normally shown
deactivated when there are memorised blank and/or
calibrator results.
Absorbance Memorised blank or calibrator absorbance value.
Date Date on which the blank or calibrator was made.
Factor Memorised factor value.

The following information is shown in the control tab:

Column name Description of the control tab fields

Selected The controls appear unselected. When the position
button is pressed only the selected controls and tests are
sent.
Control Control name
Lot Control lot
Tests Test name
Type This indicates the sample type
# Rep The number of replicates is usually shown programmed
in the test. The replicates of the controls can be changed.
Tube This indicates the type of tube when it is to be put in
position. It may be a sample well or a tube. The user can
change the type of tube by selecting it from the pop-up
list.
Exp. date This indicates the control lot expiry date.

This button allows you to eliminate tests and samples from the work session.
First select the row to be eliminated and then press the button. The blanks and

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 calibrators are automatically eliminated if there is no other patient with that
test. The controls can also be eliminated.
It allows you to save a session and retrieve it later. The programme will ask you
to enter a name for the session.
It allows you to load a previously-saved session. The programme will let you
select the name from a list of saved sessions.
Press this button to send the samples and reagents to be positioned in the ro-
tors. The programme will automatically change screen. Once the samples have
been sent to the positioning screen they are marked in grey.
))Chapter 10.5.2 describes the procedure for positioning on the rotor.
Press the button to open up the screen for entering the results for all patients
with external tests.
))See Figure 74

Figure 74 Screen for entering the value of external tests

10.5.2. Additional entering of patient information

In this screen you can enter the patient information of the samples in the current
session, or samples selected in the historical screen. When using this screen outside
historical logs, a work session must be created, i.e., sample codes must be entered
and the tests requested for these samples.
You can enter the patient information at any time before, during or after executing
the work session. This way, the user can prepare a session and immediately execute
it in the analyser, and enter additional patient information afterwards.
If you press the icon, a pop-window will appear on the left with a list of all the
samples ordered by the patient identifier.

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The samples sent via LIS are shown in the list, marked with an identification label
and in grey, to facilitate their identification. You can consult their data but they
cannot be changed.

Figure 75 Pop-up screen for entering patient information

The right-hand side of the window shows the patient data fields for the user to
enter the information. All the fields are optional.
The information can be entered quickly using ENTER or TAB which takes you
to the next field. When you reach the last field and press ENTER or TAB you are
taken to the next sample on the list.
Given name Patient name. On entering the letters of the name, a search is made and a list is
shown with the matching names stored. The user can select a name from the list
or enter a new one. In the latter case, the name will be stored for future use.
Last name Patient surname. A pop-up window is also generated with suggested surnames
to facilitate data entry. The suggested surnames are only those with the name
entered in the previous box.
Gender Male/Female/No value. Press the initial to quickly select the option.
Date of birth Patient’s date of birth. If the date is not entered correctly, it will be shown in
red and not memorised, but the field will not be blocked. It allows you to enter
the date in any operating system regional setting format (short or long format).
For patients aged less than 1 year, it is not necessary to enter the year. The age is
calculated automatically.
Performed by Open field for entering the name of the person who requested the tests of each
patient. This field will appear in the patient report.
Comments Open field with several lines for entering comments. This field will appear
in the patient report. You can enter comments with a line break by using the
CTRL + ENTER key combination.
Deletes all the data of the current patient from the pop-up screen.

Press this icon to undo the changes made for the current patient.

Press this icon to go on to the next patient.

Press this icon to go back to the previous patient.

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 Press this icon to go to the last patient.
Press this icon to go to the first patient.
Press this icon to go to the previous patient with no data entered.

Press this icon to go to the next patient with no data entered.

Press this icon to close the pop-up window. By default, all the changes are stored
without having to press any other icon to save the data. You can also close this
screen with the ESC key.

10.5.3. Rotor positioning

This screen indicates the positioning of the reagents and samples. The reagent and
sample positioning process may be executed manually or automatically.
The screen shows the following information:
))See Figure 74
On the left there is a list of all the reagents and samples of the work session that
are to be positioned. The elements not yet positioned are shown in black, whereas
the elements in position are shown in green.
In the centre, the sample and reagent rotor allows you to see the positioned ele-
ments, identified by an icon.
On the right there is detailed information about the position selected in the sample
and reagent rotor.
Manual positioning Select an element from the tree and drag it with the mouse to the position in
which you want it to be in the rotor. Repeat this process for each of the tree
elements.
This button also positions all the patient samples, controls and calibrators
automatically. The patient samples will be positioned starting in the first posi-
tion that is empty. The calibrators and controls can start to be positioned from
position 1.
This button automatically positions the reagents. The special solution bottles
(physiological saline solution, washing solution, etc) are put in place starting in
the last position, in descending order of positions.
You can move the elements positioned on the rotors by dragging them to another
empty position.
This button reads the barcodes of the analyser samples and reagents. If LIS
requests have been entered or received for the read samples, all the informa-
tion is listed and these samples appear in yellow (ready to be executed). If any
of the read samples has no tests assigned, the user can enter them in the auxil-
iary screen (see Figure 68) or request the tests from LIS. If information on the
sample type is missing from any of the read samples, the user must enter this
information.

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The samples placed in sample wells will not be read by the barcode reader and the
user must position them by dragging them manually or using the auto-positioning
button.
In the event of automatic barcode reading, when the session start button is pressed
(with Host Query activated), all the rotor positions will be read and the codes will
be matched with the orders pending in LIS.
When more than one bottle with the same reagent has been positioned, the pipet-
ting order will be the same as the order of each bottle on the rotor.
If the samples have barcodes that do not correspond to the work session samples,
the user can enter the necessary additional information: type of sample and test
to be performed on each sample.
If the programme detects an erroneous barcode, this is indicated by an icon over
the rotor position. Erroneous barcodes can be corrected manually.

Figure 76 Screen for positioning the reagents and samples

Press this button if you want the analyser to automatically identify the session
samples positioned on the rotor. These samples will be shown in yellow. The
read barcodes that have not been matched with any of the requests on the list
will be shown in grey, and the user can assign the tests using the screen shown
in Figure 77. Elements in sample wells such as calibrators and controls will have
to be positioned manually or with the auto-positioning button.
Button for warnings related to elements required for the work session. When
this button is pressed a message will appear informing you of all the elements
that have still to be positioned. The same message will appear if an element has
not yet been positioned when the positioning screen is closed.
The programme will block all tests/samples in the event that a component required
for their execution is missing. Below are examples of cases in which blocking occurs:

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 Component not Rotor Blocking
in position
Distilled water Samples The test will be blocked when it is
performed for the first time and there are
no blank result values.
Calibration Samples The test will be blocked when it is
performed for the first time and there are
no factor result values.
Diluent bottle Reagents This is used to perform automatic or
manual repetitions with a sample dilution.
The test will be shown as blocked when
no diluent is detected on activating the
repetition (either because the bottle is not
in position or the volume is insufficient).
The test programmed with the pre-dilution
will be blocked.
This is used to pre-dilute samples (for
URINE or other tests). If it is not
positioned on the rotor, the test will be
shown as blocked.

Press this button to print out a report of the positions of all the elements in the
current session.
Press this button to memorise the elements positioned in the visible rotor. The
program will request a name for identifying the memorised rotor. When per-
forming a session reset, the positioned reagents are maintained, but the samples
are emptied.
Press this button to load the positions of the elements of a rotor that was previ-
ously memorised.
Press this button to delete the reagents or samples positioned on the rotor.
When the button is pressed a selection menu appears for the user to select the
sample or the reagent rotor.
Press this button whenever you run out of volume. Perform this action when
the volume termination alarm is triggered. For reagents with barcodes you only
need to place a new bottle on the rotor and press the barcode reading button
and the information on the volume of the new bottle will automatically be
updated.
Press this button to release the samples and reagents shown in red due to detect-
ing a clot or a tip collision. Before pressing it, the user must carefully check
the tubes of elements in red and decide on the appropriate course of action:
eliminate the clot, correct the tube size, position the tube correctly, remove the
reagent bottle cap, etc.
On pressing the button, a pop-up window emerges in which the user can enter
additional patient information from the work list.
))Chapter 10.5.2 explains how to enter additional patient information.

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10.5.4. Creating the worklist from the sample positioning screen

When reading a sample barcode of sample tubes positioned on the rotor, if there
are no tests requested for any of the samples, this screen will automatically open
up. It permits the work session to be completed by requesting information from
the LIS through a Query by specimen or manually.
It also allows adding test to positioned tubes that they have not assigned test (tubes
that are gray). Test can be added manually or through the host Query.

Figure 77 Screen for creating the work list from positioning

This screen also appears when making a Host Query.

))See chapter 17 for Host Query details.
A table appears in the screen with the following information:

Column name Description of the fields

Cell Position of the specimen on the rotor.
Barcode Information read from the specimen barcode.
Sample ID Sample identifier, depending on the barcode
configuration it may coincide with the barcode digits.
Type This indicates the type of specimen. Its entry comes
from the worklist or the information from the LIS.
In specimens containing this same information in the
barcode, it is checked that the information coincides. In
cases in which the sample type does not form part of the
barcode and several specimens are read with the same
code, a message will appear for determining the type to
which each specimen belongs.
Urgent This indicates whether the sample is urgent. Its entry
comes from the worklist or the information from the
LIS.

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 Column name Description of the fields
Status Information only appears when making a Host Query.
It indicates the status of requests to the LIS. It has the
following states:
• ASKING: Request sent to the LIS
• PENDING: Request already sent and awaiting
receipt of the worklist for the sample.
• REJECTED: Request rejected by the LIS.
• NO INFO: The LIS has no information about this
sample.

Select all It allows the selection of all the specimens in order to request the LIS for the
work order or to manually create the worklist.
Button allowing a Query All to be made directly to the LIS from this auxiliary
screen.
The bottom of the screen allows you to create the worklist manually after the
specimen barcodes have been read. To do this, select the specimen or group of
specimens and assign the sample type, if it is urgent, and assign tests using the
TEST button. Once you have done this, press save and continue with the next
specimen.
If the sample type is not coded in the barcode, the type must be assigned manually
to all the specimens. To do this, select all the specimens or a group of specimens
and assign the sample type from the pop-up box at the bottom of the screen.

10.5.5. Worklist setup

After creating the work session and once positioned on the rotor, the session can
be executed.
Press the start button to execute the work session and the analyser will start to
execute the list.
If the equipment is connected to a LIS system without a work list, press the start
button directly and the analyser will read the specimen barcodes, create the work
session downloaded from the LIS and start executing it.
))See chapter 17.1 to see the details regarding operation with the LIS
Press this button to pause the worklist, add samples without waiting for the ses-
sion to end or to correct a session volume alarm, for instance, filling an empty
specimen or adding more specimens to the sample rotor. To continue with the
work session in progress, press the start button again and the analyser will im-
mediately continue executing the list at the point where it had stopped. If the
analyser is connected to a LIS system, when the start button is pressed after the
pause, the analyser will read the barcodes and request the LIS for the specimens
and add the new preparations to the work session.
When it is in pause mode minimize the pause time. In some cases the reaction
in progress may be affected by the pause, and in this case a message will appear
recommending the user not to pause at that time, but to complete the critical
NOTE reagent preparations.

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Press this button to stop or abort the work session. Once the button has been
pressed, the screen shown in Figure 78 will appear.
Select one of the following options:
• Stop: This action stops the work session, ends the preparations in progress
until a concentration result is given and does not prepare any more. The next
action to be taken is to reset the work session.
• Abort: This action aborts the work session. The execution of the list stops im-
mediately and the preparations in progress in the analyser are lost. The next
action to be taken is to reset the work session.
• Cancel: Closes the window and continues executing the current list.

Figure 78 Screen with abort message

10.5.6. Save session

Menu option at Work session that allows you to save the created session with a
name. This function is used for saving repetitive lists, such as lists of blanks, cali-
brators and controls.
If this option is selected, a pop-up window opens. Enter a name for the session
and then press the accept button.
This action does not memorise the sample or reagent positions on the rotors; it
only memorises the session.

10.5.7. Load session

Menu option at Work session that allows you to load a previously memorised ses-
sion. When this option is pressed a pop-window opens. Select the name and press
the open button. This action may also be executed in the Sample Request Screen.

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10.5.8. Delete session
Menu option at Work session that allows you to delete a previously memorised
session. When this option is pressed a pop-window opens. Select the name and
press the delete icon.

10.5.9. Delete virtual rotors

Menu option at Work session that allows you to delete virtual rotors memorised
previously in the sample and reagent positioning screen. The virtual rotor is a
name used to identify the positions of reagents or samples on a rotor. For the list
of names to be displayed, the rotor must have previously been memorised in the
positioning screen.
When this option is pressed a pop-window opens. Select the name of the virtual
rotor and press the delete button.

10.6. Current state monitor

This allows you to see all the information about the current status of the analyser,
the work session, positionings, monitor of reactions, ISE staus (when it is available)
and alarms in graphic form. It enables the status of the session to be observed in
real time (samples in progress, completed or with errors, or blocking actions due to
the absence of a reagent or sample). It allows you to quickly view the reagent and
sample volume alarms and know the current volume of the reagents. It also allows
you to access the absorbance curve screen during the reception of the results and
the results screen when a test has been completed. Since all the screen tabs have
information purpose, it is not possible to execute anything over these.

10.6.1. Main
Screen which informs about the status of the analyser: the analyser elements that
are switched on (refrigeration system, ISE module), main sensors (covers, tem-
peratures), work session times, graphic information on alarms and information
on processes being executed by the analyser.

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Figure 79 Monitor display

State On and connected indicators:

• The analyser is on and connected to the computer when it is green.
• The refrigeration system is on when it is green.
• The ISE module is on and correctly initialised when it is green. When it is
red, this means it is on but cannot be used due to an initialisation problem.
When in grey, it is not installed or it is off.
Temperature This indicates whether the temperature of the rotor and the refrigerator are
within the established limits.
When an alarm is triggered a series of informative bubbles appear on the main
screen indicating where the alarm was triggered in the analyser and giving a
brief explanation.
Some of the alarms indicators could be disabled due to the configuration of sensors
deactivation by Service Software.
))See alarm screen in chapter 10.6.6

10.6.2. Worksession
This tab displays information about the work session being performed by the
analyser, the state of the samples and of the tests.
The information is organised in a table with all the samples and tests of the session
and a graph summarising the state of the preparations.
The work session is ordered so that emergencies are always executed first. Before
the patient samples the blanks, calibrators and controls of the tests assigned to
the patients are executed.

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 Figure 80 Work session screen

The table shows the state of the samples and tests through a colour code and ad-
ditional information using icons.

Colour code Description

State of a test that is pending preparation

Test in progress of being prepared and read

Test completed and with results

Indicates that the test or patient has been completed correctly.

Indicates that the test or patient has been completed with alarms or remarks.
Button for viewing the reaction curve. Viewing may be in real time or after the
reaction has ended.
Indicates that the final patient report has been printed because it has been
completed.
Indicates that the results have been sent through the LIS system.
Indicates that the test or patient is blocked. This may be due to an alarm indi-
cating the absence of a sample and/or reagent, or problems with the blank or
test calibrator.
If you double-click on the box of a test, this temporarily blocks the test and
prevents it from being executed. Double click again on the same test to unblock
it. It is only possible to block patient tests or complete patients in which the
preparation has not yet been initiated.

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Test status This graph informs you about the total number of preparations requested and
their status: completed, in progress, pending, blocked and completed with
alarms.

10.6.3. Sample and reagent

Screen with information about the state of each sample tube and reagent bottle.
It corresponds to the sample and reagents tab of the monitor screen.
The user can press any tube, well or reagent bottle to see the information in detail.
There is a colour code for identifying the status of each sample tube or well.

Colour code Name Description of the sample identification

Selected Selection of a rotor position.

Not used Sample positioned but not assigned in the

work session.
Insufficient Shows that the analyser has detected
volume /blocked insufficient volume or a clot or collision.
by clot or tip The programme will block the other tests
collision that have not yet been performed on that
patient. To release the samples due to
insufficient volume, the user must fill the
sample and press the fill button in the
positioning screen.
To release the samples due to detecting a
clot or collision, the user must check the
status of the samples and press the release
button in the positioning screen.
Pending or Sample pending execution or blocked
Blocked manually.
In progress Sample being processed.

Completed Sample terminated.

Error in code Error in barcode reading.

reading

There is a colour code for identifying the reagent bottles status.

Colour code Name Description of the bottle identification

Reagents Reagent bottle used in the work session.
Additional Bottles of washing solution, purified water,
solutions physiological saline solution, etc.

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 Colour code Name Description of the bottle identification
Insufficient Reagent bottle in which the analyser has
vacuum / detected insufficient volume for making
Blocked due to the preparation. The programme will block
collision all the subsequent preparations using that
reagent. To release the bottles due to insuf-
ficient volume the user must insert a new
bottle and read the barcode.
To release the bottles due to a collision the
user must check the positions of the bottles
affected by the collision and press the release
button to be able to reuse that bottle.
Insufficient Warning low volume.
volume
Not used Reagent positioned but not used in the work
session.
Error in code Error in barcode reading.
reading
Unknown Bottle positioned but not identified.
Selected Bottle selected.

This screen is for information purpose and cannot be used for making changes in
the sample positions or resolving volume alarms. To do this go to the sample and
reagent rotor position screen.
))See chapter 10.5.3

10.6.4. Reactions
Screen informing the status of each of the reaction cuvettes. It corresponds to the
reactions tab of the monitor screen.
The user can press any cuvette to see detailed information about its content or the
preparation it contains. It also allows the reaction curve to be accessed when the
cuvette contains a preparation.
There is a colour code for identifying the status of each cuvette.

Colour code Name Description of the identification

of the status of the cuvette in the
reaction rotor
Washing Cuvette in the washing status.

Not Used Cuvette not used. Empty.

R1+sample R1 and sample dispensed.

R1+sample+R2 R1, sample and R2 dispensed.

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Colour code Name Description of the identification

of the status of the cuvette in the
reaction rotor
Sample dilution Cuvette with sample dilution.

Completed Cuvette with reaction completed.

Contaminated Cuvette contaminated. If the cuvette

contains a contaminant test, it is
marked as contaminated. That cuvette
will not be used during the next turn
of the rotor and will enter the cleaning
process to be used in the next turn of
the rotor.
Optical rejection Cuvette optically rejected. The
absorbance of each cuvette is measured
in the wash station. If the absorbance
levels are within the ranges, the
cuvette is accepted, otherwise it is
rejected and the cuvette is not used to
make the determinations.

10.6.5. ISE module

Screen showing detailed information about the ISE module (if installed in the
analyser). It corresponds to the tab in the ISE module of the monitor screen.
• Dates: Shows the installation dates of the reagent kit, each of the electrodes,
the pump and electrode calibrations and the last cleaning operation performed.
• Consumption: Shows the estimated consumptions of calibrators A and B and
the number of preparations made for each electrode.
When installing a new reagent kit or electrode, the installation date must be entered,
and calculation of consumptions and preparations will automatically be started.
This screen also shows messages about expiry dates and changing recommendations
when the electrodes are exhausted or if they have expired (installed for more than
6 months or exceeding the recommended number of preparations).
It also displays warning messages if the calibrations have incorrect results.
The programme automatically checks whether there are any warnings or recom-
mendations for changes that make it impossible to obtain correct results. In this
case a reminder appears and the user can either continue or solve the problems
in the ISE module.

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 Figure 81 ISE module monitor display

10.6.6. Alarms
Screen showing a list of all the alarms that appear while the analyser is operating.
It corresponds to the alarms tab of the monitor screen.
Each alarm has the following information:
• type, indicating the severity. Serious alarms can interrupt the analyser opera-
tion.

Icons Description
Warning icon. Indicates that an alarm has gone off which requires
the intervention of the user. This type of alarm does not interrupt
the operation of the analyser.
Icon indicating that the alarm has been resolved.
Icon indicating a serious alarm. Indicates that a serious alarm has
gone off and operation is interrupted. Depending on the type of
alarm, for instance, detection of a collision in one of the tips, the
user will have to press the analyser recovery button to resolve the
alarm.

• Date
• Time
• Alarm name
• Alarm description
• Possible solution

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The alarms are ordered by date and time of arrival, but they can be ordered using
any other criterion. Press the column header in which you want to order them.
If pressed once, they will be ordered in ascending order, and if pressed twice, in
descending order.

10.7. Worksession results

Option in the main menu for accessing the results screen for the current session
(completed or in progress).

Figure 82 Results screen

On the left is a list of patients and tests performed in the session (separated into
two tabs). It allows you to see all the results for each patient or all the results for
each test. Select an element from the list to see the results in the tables on the right.

10.7.1. Results by patient

First select the patient tab and a list of all the patients with results will appear
below in the left-hand column.
Select a patient and all the information on the result of that patient will be dis-
played on the right.

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 Patient tab Field Description
Buttons allowing you to show or hide the replicates
with a result.
If you press the header icon, all the patient tests will
be shown or hidden.
Only one of the two icons appears. Every time you
press the icon, one will be changed to the other
alternatively.
OK Indicates that the result has been accepted. It will
be sent to the historical log and to LIS. When
repetitions are executed the last result is always
accepted.
This indicates whether it was sent to LIS
automatically or manually.
New This allows you to repeat a preparation.
This option is deactivated if the repetition
option has only been selected for LIS in the LIS
configuration screen.
))
See the different repetition options in chapter 10.7.4
Test Test name
Type Sample type
This allows you to access the kinetic reaction graph.

Number Indicates the replicate number, if there is more than

one replicate.
Absorbance Absorbance value of the sample obtained.
Concentration Concentration value calculated in accordance with
the calculation method programmed in the test.
Units This shows the units programmed in the test.
Reference ranges This shows the reference ranges programmed in
the test. If there are patient data and demographic
ranges, then it automatically selects the ranges based
on the patient data.
Remarks This displays the alarms that could appear in the
results.
))
See the possible alarms in chapter 13
Date Date on which the result was delivered.
Repetition mode This shows the mode in which the sample was
repeated.

Press this icon to print out the final patient reports.

Press this icon to print out a report with all the patients in a compact way.

Press this icon to see a summary table of the results. A table appears with the
results of all the patients and all the tests of the session in progress.

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Press this icon if you want to print out a list of the patient results including the
absorbance values obtained.
Press this icon to manually send the selected results to a LIS laboratory informa-
tion system.
Press this icon to enter the external test results. When the button is pressed an
auxiliary screen appears in which you can enter the external test values (the test
must be selected previously for the button to be activated).
))See chapter 10.3.9
Press this icon to send the selected samples for repetition.(I.e., tests with the
New field activated).
This option is deactivated if the repetition option has only been selected for LIS
in the LIS configuration screen.
))See the different repetition options in chapter 10.7.4

10.7.2. Results by test

Select the test tab to see the list of tests performed in the session.
Select a test from the list and four tabs will appear on the right with all the results
of that test. Select the screen, depending on the information you want to see:
blanks, calibrators, controls and patients.
All the replicates and the resulting mean are shown in the results tables.
You can rule out the replicates by pressing on the row you want to eliminate. This
will show the replicate that was deleted and recalculate the resulting mean without
that replicate. You can reactivate it by pressing the replicate row again.
The blank results table contains the following information:
Blank tab Field Description
Buttons allowing you to show or hide the replicates
of a result.
Only one of the two icons appears. Every time you
press the icon, one will be changed to the other
alternatively.
OK Indicates that the result has been accepted. It will
be sent to the historical log and to LIS. When
repetitions are executed the last result is always
accepted. If you like, you can accept various results
or none.
New This allows you to repeat a preparation.
))
See the different repetition options in chapter 10.7.4
Test Test name
This allows you to access the kinetic reaction graph.

Number Indicates the replicate number, if there is more than

one replicate.
Absorbance Final calculated absorbance for the test.

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 Field Description
Absorbance Reagent This shows the R2 absorbance value. Only shown in
tests with differential programming.
Kinetic blanc limit This value is programmed in the test. It is used to
check the slope of the kinetic reaction exceeds that
limit.
Initial abs. This shows the first value of kinetic absorbance.
Only shown in tests with kinetic and fixed time
programming.
Absorbance main filter This shows the main filter blank absorbance
value. Only shown in tests with bichromatic
programming.
Blank absorbance limit Blank limit value. This value is programmed in
the test. It is used to check that the reagent is in
good condition. Either in incresing reactions, if
the absorbance exceeds the established limit, or
in decreasing reactions, if the absorbance is below
the established limit, the programme will issue a
warning message in remarks.
Remarks This displays the alarms that could appear in the
results.
))
See the possible alarms in chapter 13
Date Date on which the result was delivered.
Repetition mode This shows the mode in which the sample was
repeated.

The calibrators results table contains the following information:

Calibrators tab Field Description

Buttons allowing you to show or hide the replicates
of a result.
Only one of the two icons appears. Every time you
press the icon, one will be changed to the other
alternatively.
OK Indicates that the result has been accepted. It will
be sent to the historical log and to LIS. When
repetitions are executed the last result is always
accepted. If you like, you can accept various results
or none.
New This allows you to repeat a preparation.
))
See the different repetition options in chapter 10.7.4
Name Calibrator name
Lot Calibrator Lot
Type Sample type.
This allows you to view the kinetic reaction graph.

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Field Description
Number Indicates the replicate number, if there is more than
one replicate.
Absorbance Calibrator absorbance value that will intervene in
calculating the factor.
Theoretic concentration Calibrator concentration value. This value comes
from the test programming.
Units This shows the units in which the test has been
programmed.
Factor Value calculated based on the calibrator absorbance
that will intervene in calculating the concentration.
Factor limits Factor limit entered in programming the test. If
the factor value is off limits, a warning message will
appear in the remarks field.
Remarks This displays the alarms that could appear in the
results.
))
See the possible alarms in chapter 13
Date Date on which the result was delivered.
Repetition mode This shows the mode in which the sample was
repeated.

The control results table contains the following information:

Control tab Field Description

Buttons allowing you to show or hide the replicates
of a result.
When the header icon is pressed, all the different
controls of the test are shown or hidden.
Only one of the two icons appears. Every time you
press the icon, one will be changed to the other
alternatively.
OK Indicates that the result has been accepted. It will
be sent to the historical log and to LIS. When
repetitions are executed the last result is always
accepted. If you like, you can accept various results
or none.
Indicates whether it was sent to LIS automatically
or manually.
New This allows you to repeat the result.
))
See the different repetition options in chapter 10.7.4
Name This shows the control name.
Lot This shows the control lot.
Type This shows the type.
This allows you to view the kinetic reaction graph.

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 Field Description
Number Indicates the replicate number, if there is more than
one replicate.
Absorbance Absorbance value of the control obtained.
Concentration Calculated concentration value of the control.
Units This shows the units programmed in the test.
Concentration limits This shows the maximum and minimum limits for
the controls entered in programming the test.
Remarks This displays the alarms that could appear in the
results.
))
See the possible alarms in chapter 13
Date Date on which the result was delivered.
Repetition mode This shows the mode in which the sample was
repeated.

When the patient tab is selected the information viewed is detailed in chap-
ter 10.7.1.

10.7.3. Reaction graphs

Press this icon to view the reaction kinetics graphs. A screen like the one shown
in Figure 83 will appear. A single replicate or all at one time can be viewed. If
there is a pause during the work session, the reaction rotor reading system con-
tinues reading. Those readings are marked with a black triangle in the reaction
graph.

Figure 83 Reaction kinetics graph screen

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The reaction graph button can be accessed in the results, work session and reac-
tions screens.

10.7.4. Result repetitions

The programme automatically performs repetitions already programmed.
The automatic repetition modes are the following:

Type Repetition criterion

Linearity limit Repetition with decrease
Detection limit Repetition with increase
Substrate depletion Repetition with decrease
Repetition range Repeat with the same conditions

You can request the repetition of tests manually by selecting the New field in the
results table.
To do this press the New field and a window like the one shown in Figure 84
will appear. For automatic repetitions, the increase/decrease factor will be that
programmed by default in Procedure screen of Tests Programming.
You can select the repetition criterion at that time for the patient samples. The
criteria are:
• Repeat with an increased sample. The programmed test value is usually shown.
If the value is changed, the programme warns the operator that the test limit
established has been exceeded. This repetition changes the ratio of volumes
between sample and reagent for increasing the sample absorbance. The re-
sulting concentration is divided by the increase factor. This repetition is used
to increase the sensitivity of samples below detection level limit. Its limit is
according the default test programming and the limit of pippeting for both
reagents and samples. The lower the sample pippeting volume is, the more
times you will be able to concentrate.
• Repeat with a reduced sample. Enter the dilution factor of the sample. The
programmed test value is usually shown. The user can enter a value between 2
and 200. The repetition makes a prior preparation for diluting the sample and
then it prepares the measurement based on the diluted sample. The resulting
concentration is multiplied by the dilution factor. This repetition is used for
samples that are outside the linearity limits, that have a substrate depletion.
alarm or for samples that are outside the calibration curve.
• Repeat under the same conditions programmed in the test.

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 Figure 84 Screen for selecting repetitions

Assign the repetition.

Close the screen without selecting a repetition.

Recover the recommended dilution factors (the same ones programmed in the
test).
The blanks, calibrators and controls have these options deactivated, as they are
always repeated with the same initial conditions.
Each row of results has an informative icon indicating the type of repetition crite-
rion applied (for both automatic and manual repetitions). There is an identifying
icon for the original result and another for the repeated result

Field Description of the icons in the results

Indicates whether an increased repetition of a sample has been
requested.
Indicates whether a decreased repetition of a sample has been
requested.
Indicates whether a repetition with the same conditions of a
sample has been requested.
Indicates that the result comes from an increased sample.

Indicates that the result comes from a decreased sample.

Indicates that the result comes from a repeated sample.

10.8. Historical logs

10.8.1. Patient results

This screen displays the historical results of the patients.
At the top of the screen there are several fields that permit the entry of selection
criteria for restricting the viewing of the results. More than one selection criterion
may be selected at one time.

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After making the selection, press the icon to execute the search and view the
results at the bottom of the screen.
Date range Enter the start and end date for selecting the results by a date range.
Patient Enter the patient code, name or surname to select the results by patient. All the
results for a patient starting with the value entered are displayed.
Barcode Enter a sample barcode to select the results.
Urgent The available options are: All, urgent or routine.
Test type The available options are: All, standard, calculated, ISE, external
Sample type The available options are: All, SER, URI, PLM, WBL, CSF, SEM, LIQ.
Test name Enter the name of the test to make the selection.

Figure 85 Screen showing historical results for patient

The results are shown in a table, ordered by date. On pressing the heading of a
column in the table, the results of that column will be rearranged.
Press this icon to display the results of the next page.
Press this icon to display the last results.
Press this icon to display the results of the previous page.
Press this icon to display the first results.
Press this icon to print out the results that were previously selected. If you want
to select all the results, press the heading selection box.
Select this icon to print out the results with a compact report, i.e., with no
patient header and all the results shown continuously.
Press this icon to send the selected results to a LIS laboratory information sys-
tem. This is a manual export.

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 Press this icon to eliminate the selected results. Once eliminated, they cannot be
recovered.
On pressing the button, a pop-up window emerges in which the user can
complete and change additional patient information from the historical results
selected.
))Chapter 10.5.2 explains how to enter additional patient information.

10.8.2. Blank and calibrator results

Screen for saving the blank and calibrator results from previous sessions.

Figure 86 Screen showing historical logs of blank and calibrator data

At the top of the screen there are several fields that permit the entry of selection
criteria for restricting the viewing of the results. More than one selection criterion
may be selected at one time.
After making the selection, press the icon to execute the search and view the
results at the bottom of the screen.
Date range Enter the start and end date for selecting the results by a date range.
Test name Enter the name of the test to make the selection.
The results will be shown in two tables, ordered by date. The first table shows
the results of the blanks and the second one shows the results of the calibration
standards. On pressing the date or test heading in the table, the results of that
column will be rearranged.
The blank and calibrator fields displayed are the same as the fields shown on the
current session results screen, selected by test.
))See chapter 10.7.2 for a description of each field in the blank and calibrator screens.

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10.8.3. Quality control results

Screen that allows you to review the current quality control results. It also allows
you to change the defined calculation criteria and view the results in graphic format.
The quality control results of the active work session will not be available on the
screen until the reset function has been executed.
Up to 500 results can be stored and viewed for each control and test. When reset-
ting the active work session, this condition is verified for each control and test with
quality control results in the session and in the event that the maximum has been
exceeded, a screen appear saying that the current results (except those of the work
session) will be accumulated. The user can accept the warning and accumulate the
results automatically, or temporarily cancel the reset and accumulate the results
manually in the daily quality control Accumulate results screen.
))See the explanation of how to accumulate results in chapter 10.8.4.1.
On the left is a list of tests with quality control results pending review. In selecting
a test from the list, the information about its programmed and active controls is
shown on the right of the screen, but only for those with at least one non-reviewed
result. There are three clearly defined zones in this list area:
• Calculation criteria. This allows you to specify the criteria for selecting and
validating the quality control results. When the normal value of any of these
criteria is changed, the content of the other two list zones is emptied and you
must press the search button to reload them. The values selected will also be
updated in the test programme (except the selection of the Westgard rules).

Figure 87 Screen for manual entry of quality control results

Date range Range of dates of the results to be viewed. The date range reported by default is
that which allows all the results pending review to be displayed.

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 formula24-ENG

Rejection criterion Number of standard deviations for determining the admissible value interval
limits for the results:
formula18-ENG
Range=Mean± Rejection criterion⋅SD

The programmed rejection criterion for the test is normally returned.

Calculation mode
formula19-ENG
Indicates how to calculate the target values for each test: mean, standard devia-
tion (SD) and coefficient of variation (CV). If the selected calculation mode is
Statistical, the number of the series that will be used for calculating the target
values must also be given.

Calculation mode Calculation method

Manual The values programmed in the test are used for each
control:
Maximum valueMinimum value
Mean=
2
Maximum range−Minimum range
SD=
2⋅Rejection criterion
Statistical The results of the n first series (n = specified series
number) are used:
n

∑ Xi
Mean= i=1
n


n

∑  xi−Mean2
i=1
SD= criterion cdot SD )
Range = Mean +- (Rejection
n−1
SD
CV = ⋅100
Mean

The programmed calculation mode for the test is normally returned.

Application of rules This allows you to select the rules that will apply in validating the results and
controls to which they will be applied. The available set of rules are those in-
cluded in the Westgard algorithm, but they may be applied optionally except in
the case of the 1-2s which is always applied.
The rules selected are usually those programmed for the test. If the selected test has
Mean={Maximum
results for a single control, the selected value + Minimum
rules will be applied tovalue} over if2the
it. However,
selected test has results for two controls or more, the active rules will be applied
to both
SD the selected controls.
= {Maximum range - Minimum range} over {2 cdot Rejection criterion}
Execute the search and validation of results applying the selected calculation
criteria.
• List of controls. This shows the statistical information for all active controls
with results pending review for the selected test. The tick activates/deactivates
the viewing
Mean of thefrom
= {sum listed i=1
individual results.
to n {X_i }} over {n}

SD = sqrt {sum from i=1 to n (x_i - Mean)^2 over {n-1}} 135

User manual formula19-ENG

The target values for each control are shown in the columns on the left: means,
standard deviation (SD), coefficient of variation (CV) and admissible range of
values, calculated in accordance with the selected calculation mode and rejection
criteria.
The columns on the right (Results area) show the statistical values for each control,
calculated based on the available results:

Results parameters Calculation method

n Number of results used in the calculation
Mean Statistical mean of the results.
n

∑ Xi
Mean= i=1
n
SD Standard deviation of the results:


n

∑  xi−Mean2
i=1
SD=
n−1

CV Coefficient of variation of the results:

SD
CV = ⋅100
Mean

If the statistical calculation mode is selected, the results used for calculating the
target values are not used in the calculation.
• Details of individual results. This shows the individual results for all the
controls selected within the specified date range, validated pursuant to the
indicated calculation criteria. The information displayed for each result is the
following:

Parameter Description
n Number of series executed.
Name Name of the control to which the result belongs
Date Result date/time.
Mean = {sum from i=1 to n {X_i }} over {n}
Result Result value.
Manual result The result changed icon is shown if:
indicator • the result value has been changed manually
• the result has been entered manually
Unit Result measuring unit
SD = sqrt {sum from i=1 to n (x_i - Mean)^2 over {n-1}}
Absolute error Difference between the result value and the target mean.
Relative error Absolute percentage of error divided by the target mean.

CV = SD over Mean cdot 100

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 Parameter Description
Alarms Alarms generated while the result is being validated.
These include:
• result outside admissible value range
• infringing of rules applied
Results with alarms are shown with red lettering.

In addition, if the calculation mode is statistical and the results used to calculate
the target values are included in the results group in the displayed set of results,
the symbol Xm is shown to the left of the number of the series executed.
This opens up the auxiliary screen for entering a new series manually, giving the
date, time and value of the result for one or more of the available controls.
The added results are shown with the icon changed in the listed Individual results
table
))Figure 88 shows the screen for entering new results.
Opens the auxiliary screen for changing the value of the selected result (only the
value, the date cannot be changed) or temporarily exclude it from the calcula-
tion and validation processes. An excluded result can be included later.
The Listed individual results table shows the changed results with the respective
icon and the excluded results are shown deleted and on a grey background.
))Figure 89 shows the screen for editing results.
It allows you to permanently delete the results selected.

Opens the auxiliary screen that shows the results in graphic format. The display
type can be selected: Levey-Jennings or Youden. The controls to be graphed can
also be selected: between 1 and 3 for Levey-Jennings and between 1 and 2 for
Youden.
In the Levey-Jenning graph the Y axis values will depend on the number of con-
trols graphed:
• If only one control is graphed, it will display concentration values and the
scale of the standard deviation in multiples.
• If several controls are graphed, it will show the values of the scale, in standard
deviation multiples.
))Figure 90 and 84 show the screens of the Levi-Jenning and Youden graphs respectively.

Figure 88 Screen for entering quality control results

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User manual

Figure 89 Screen for editing quality control results

Figure 90 Screen with the Levy-Jennings graph

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138
 Figure 91 Screen with the Youden graph

The buttons located at the bottom of the screen are always available:
Opens the screen that allows the current quality control results to be accumu-
lated by control and test.
))See chapter 10.8.4.1

10.8.4. Cumulative quality control results

10.8.4.1. Accumulated daily quality control results

After a certain period of time during which the user has used the same working
conditions, the routine control results can be accumulated to compare them with
historical results from previous series and with future series.
Up to 500 accumulated results per control and test can be stored, for which reason
once accumulated result 501 has been stored, accumulated result 1 is automati-
cally eliminated.

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formula24-ENG

Figure 92 Screen for accumulating daily quality control results.

On the left is a list of controls with results for accumulation. In selecting a control
from the list, the number of the active lot will be shown on the right of the screen,
along with the list of tests with results that must be accumulated for the control.
Load the information to be accumulated for each test for the selected control.
Double-click on a control in the list for this button to function.
The information of the list of tests with results to be accumulated for the control
is set out in two tables:
• Last accumulated values: this shows the mean, standard deviation (SD)
and range of values admitted for the last accumulated item for each test, if
accumulated items exist previously for the selected control; otherwise the
respective boxes are shown as empty. Use the tick to select/unselect the test
for accumulation (the table is loaded/downloaded from Data to accumulate).
• Data to accumulate: only for the tests selected in the above table; it shows
the calculation of the values that will be accumulated:

Parameter Calculation method

n Total number of values to be accumulated
Mean Statistical mean of the results:
n

∑ Xi
Mean= i=1
n

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 Parameter Calculation method
SD Standard deviation of the results:


n

∑  xi−Mean2
i=1
SD=
n−1

CV Coefficient of variation of the results:

SD
CV = ⋅100
Mean
Ranges Range of admissible values:
Range=Mean± Rejection criterion⋅SD

If the mode for calculating the test is statistical, the results used for calculating the
target values are not included in the set of values to be accumulated.
Double click on a test in this table, open the Quality control results screen which
displays a list of the set of results to be accumulated.
))See chapter 10.8.3
Icon indicating that the set of results to be accumulated includes one or more
series with validation alarms. This icon is shown to the right of the mean.
Execute the accumulation process for the control results of the selected tests. If
all the tests are accumulated for the selected control, the control is downloaded
from the control's list.

10.8.4.2. Accumulated results

SD = sqrt {sum from i=1 to n (x_i - Mean)^2 over {n-1}}
Screen that allows you to review the historical log of accumulated results by test
and control.
It also allows you to change the target values defined for a test and control, assign-
ing the latest accumulated statistical values to them.
CV = SD over Mean cdot 100
This screen shows the accumulated results. See Figure 93 and Figure 94.

Range = Mean +- (Rejection criterion cdot SD )

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Figure 93 Quality control accumulation screen - Tabular display

Figure 94 Quality control accumulation screen - Graphic display

On the left is a list of tests with accumulated quality control results. In selecting
a test from the list the information of all the controls with accumulated results
for the test appears on the right of the screen. There are two clearly defined zones
in this list area:
• Results accumulated by control/batch: this allows you to specify the date
range of the accumulated results to be consulted. In changing the date range,
the content of both list areas is emptied and it is necessary to select the search

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 formula19-ENG

formula25-ENG
button to reload them. The information on controls with accumulated series
for the test within the specified date range specified is shown in the table, with
the following structure:

Parameters Description
N Number of accumulated series
Mean Weighted mean of the accumulated results.
Calculation method:
n

∑ Meani⋅ni
Mean= i=1 n

∑ ni
i=1

Meani is the mean for each accumulated series and ni

is the number of daily results used to calculate each
accumulated series.
Units Results measuring unit
SDobtained Standard deviation of the accumulated N series
CV Coefficient of variation
SD
CV = ⋅100
Mean
Range Range of admissible values:
Range=Mean± Rejection criterion⋅SD

Dates Date range in which the control measures were

performed on the accumulated N series

The tick is used to activate/deactivate the accumulated series for the control/lot in
the list. A maximum of 3 controls can be selected.
Date range Range of dates of the accumulated results to be displayed. The date range that is
normally given displays all the accumulated results for the selected test.
Execute the search and validation of results applying the selected calculation
Mean = {sum
criteria.from i=1 to n {Mean_i cdot n_i }} over {sum from i=1 to n {n_i}}
Execute the updating of the target values defined for the test and control/batch
selected, assigning the latest accumulated statistical values to them. Functional-
ity only available for an active control lot and for Supervisor level users.
• List of accumulated series: only for the controls selected in the previous
table; it shows the accumulated series list within the date range selected, in
tabled and graphic format. In the tabular display, the information shown for
each control is the following:

Parameter Description
CV = SD over Mean cdot 100
Number of accumulated series
Control Control name

Range = Mean +- (Rejection criterion cdot SD )

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Parameter Description
Lot Number Control lot number
Date Date and time when the accumulated series was created
n Number of individual accumulated results in the series
Mean Statistical mean of the accumulated results in the series
Unit Results measuring unit
SD Standard deviation of the accumulated results in the series
CV Coefficient of variation of the accumulated results in the
series
Range Range of admissible values for the accumulated results in
the series

This allows the selected accumulated series to be permanently eliminated.

Functionality only available for supervisor level users.
When the accumulated series list is shown as a graph, the values of the Y axis will
depend on the number of graphed controls:
• If only one control is graphed, it will display concentration values and the
scale of the standard deviation in multiples.
• If several controls are graphed, it will show the values of the scale, in standard
deviation multiples.

10.8.5. ISE Results

This screen shows the ISE electrode calibrations historical log and other ISE logs.
Electrodes Select this tab to see the ISE electrode calibrations historical log.
Pumps, bubbles and cleaning Select this tab to see the historical log of the peristaltic pump calibration, bub-
ble detector and cleaning cycles.
At the top of the screen there are several fields that permit the entry of selection
criteria for restricting the viewing of the results. More than one selection criterion
may be selected at one time.
After making the selection, press the icon to execute the search and view the
results at the bottom of the screen.
Date range Enter the start and end date for selecting the results by a date range.
Electrodes This option is only available in the electrodes tab. The available options are: Na+,
K+, Cl- and Li+

Type This option is only available in the Pumps tab. The available options are: Pumps,
bubbles and cleaning.
The results are shown in a table, ordered by date.
Press this icon to display a graph of the log containing the ISE electrode calibra-
tion results. See Figure 96.

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 Figure 95 Screen showing ISE electrodes calibration historical log

Figure 96 Graphic display of the calibrations

Figure 97 Screen showing the pump calibration historical log

10.8.6. Historical analyzer alarm

Screen showing the alarms historical log.

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At the top of the screen there are several fields that permit the entry of selection
criteria for restricting the viewing of the results. More than one selection criterion
may be selected at one time.
After making the selection, press the icon to execute the search and view the
results at the bottom of the screen.
Date range Enter the start and end date for selecting the results by a date range.
Type The available options are: All, error and warnings.
The results are shown in a table, ordered by date. On pressing the heading of a
column in the table, the results of that column will be rearranged.
Press this icon to display the results of the next page.
Press this icon to display the last results.
Press this icon to display the results of the previous page.
Press this icon to display the first results.
Press this icon to eliminate the selected results. Once eliminated, they cannot be
recovered.

Figure 98 Alarms historical log screen

10.9. Utilities

10.9.1. Change reaction rotor

When you want to change the rotor for preventive maintenance or because a mes-
sage is displayed indicating that there are too many discarded cuvettes, use the
change rotor option in the utilities menu. See Figure 99.

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 Figure 99 Rotor change

Follow the steps described below to change the rotor:

1. Open the main cover.
2. Press the button to raise the wash station.
3. Remove the reaction rotor lid.
4. Remove the screw that secures the rotor.
5. Take out the rotor and dispose of it.
6. Install a new rotor. Take care when inserting the rotor, it has only one position.
7. Screw the bolt back in place and replace on the reaction rotor lid. Close the
main cover.
8. Press the button in step 2 to tell the programme to change the rotor.
9. The analyser will lower the wash station and start the light adjustment process
with the new rotor. It will also measure the optical correction for each well.
The process consists of filling each rotor well with water, measuring it with
all the wavelengths and emptying it. This process takes about 20 minutes.
10. If there are values outside the ranges in the optical measurements, the utility
button of step 3 is activated in order to take the measurement again without
having to empty the rotor and fill it.
11. Press the button in step 4 to empty the rotor manually. You should only
do this if some of the values read are outside the ranges and then repeat the
reading process.

10.9.2. Condition analyzer

Utility for performing a fluidic conditioning operation on the analyser. It primes
the fluidic system, among other operations.
Ensure that the rear water and waste inlets are properly connected and that the
water inlet selection in the configuration screen is selected in accordance with the
physical connection.
If using an external water tank, check that it is filled with water.
Press the button to start the conditioning process. That process takes a few
minutes.

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10.9.3. ISE utilities

To perform maintenance on the ISE module, go to the utilities menu and select
the ISE utilitiesoption.
In this menu, perform the actions for performing maintenance on the ISE module.
The following utilities can be executed:
• Calibrate
• Install a reagent kit
• Install the electrodes
• Deactivate the module for a long period of time
• Change the peristaltic pump tubes
• Activate the ISE preparations
For each utility several actions must be executed. Select one of the utilities and
show the set of actions to be executed step by step.
))See the explanation of each step in detail in chapter 14.3.2.
Select an action and press the execute button. Information about the action will
appear in the results zone. It will say whether the action was successfully com-
pleted (the text is shown in green) or has errors (the text is shown in red). The
results are shown in the actions that return information, such as calibrations.
In addition each of the actions is positioned in a group under the name Installa-
tion/Activation; if the user only wants to perform one of the actions, that user can
launch it directly.

Action Description
Maintenance Empties the tubes. Only activates the waste pump. In
the repetitions parameter indicate how many times the
action must be executed.
Purge A It performs a priming cycle with calibrator A, using a
volume of 100 µL. In the repetitions parameter indicate
how many times the action must be executed.
Purge B It performs a priming cycle with calibrator B, using a
volume of 100 µL. In the repetitions parameter indicate
how many times the action must be executed.
Priming A It performs a priming cycle with calibrator A, using a
volume of 300 µL. In the repetitions parameter indicate
how many times the action must be executed.
Priming B It performs a priming cycle with calibrator B, using a
volume of 300 µL. In the repetitions parameter indicate
how many times the action must be executed.
Wash It performs a wash cycle with the ISE washing solution. In
the sample rotor pos. parameter indicate the position of the
tube with the washing solution. In the volume parameter
indicate the volume to be dispensed for washing.

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 Action Description
Activate reagent Execute this action to activate and memorise the reagent
pack kit in the programme. It is also used to memorise the
installation date and record the consumption of the
calibrators. The program issues a warning when the
calibrators are no longer usable.
Activation of Execute this action to activate and memorise the electrodes
electrodes in the programme. It is used to record the consumption
of the electrodes and warn the user when they are no
longer usable.
Activation of ISE Use this action to tell the programme you have installed
preparations an ISE module.

Figure 100 ISE module functions screen

10.9.4. LIS utilities

In this screen certain actions can be executed to solve potential problems caused
by the malfunction of the LIS programme. This functionality is only activated if
the LIS communication is activated.
Delete pending orders from Delete orders received from the LIS that have not been executed and are
LIS pending.
The LIS program must always send cancellations of orders sent to the BA200 if it
eventually decides not to execute them. In the event of a malfunction of the LIS
or the communications, the BA200 has this auxiliary tool which allows LIS orders
to be eliminated. The elimination of LIS orders in this way is reported to the LIS

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by sending a cancelled order message; in this way the LIS can record the user and
date on which this action was performed.
The intensive use of this tool is not recommended. Formally, it must always be the
LIS system that distributes orders among the laboratory instruments and reports
the cancellations to each instrument.
NOTE
The reasons why the LIS decides to cancel orders in the BA200 may be the fol-
lowing: the sample tubes do not reach the instrument, instrument alarms exist
which prevent the work from being done and the orders may be sent to another
instrument.
This action is only available if the analyser is in the STAND-BY mode and the LIS
communications are activated and free from error.
Delete internal storage queues Delete the queue of messages to be uploaded to the central LIS system. If there
is a communication problem with the LIS, the messages may accumulate in
the queue, waiting for communications to be restored. If the user is no longer
interested in sending these messages, they can be deleted using this option.
This action is only available if the analyser is in the STAND-BY mode.
Selection of Tracing Level for Allows the trace level to be configured for capturing information in the LOG
LIS communication log about the operation of communications between the LIS and the BA200. This
option is used to diagnose potential communication problems during the inte-
gration of LIS with the BA200.

Figure 101 LIS utilities screen

10.9.5. Create report SAT

If an unexpected problem arises in a programme, this tool is used to help the staff
implementing the programme locate the unexpected problem.

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 Figure 102 Screen for generating a report for the technical service.

This tool generates a file with all the programme information.

If the programme suddenly shuts down or performs an undesired action, execute
this tool.
This tool is accessed through the tools/Create Report SAT report menu or through
the icon on the horizontal bar. A screen opens up like the one shown in Figure 102.
Press the button to give the name and route where the SatReport will be stored.
The desktop route usually appears, along with the name SATReport and the
date. The file name can be edited in full by placing the cursor on the File Name
field.
Press the button to store the information in the SatReport.
Copy the file and send it to the technical service for analysis.

10.9.6. Create a restoration point with current data

This utility is used to create a copy of the whole database. It is used to make backup
copies manually.
Press the button to make the copy of the database. The file name generated by
default is: RestorePoint [Date], but a different name can be entered.
The folder where that file is stored is:
C:\Program Files\BA200\Software\RestorePoints

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Figure 103 Screen for creating a restoration point

10.9.7. Restore previous data

This utility allows you to retrieve the database saved previously at the restoration
point. A window appears with all the files created in the previous restoration point.
Select one and press accept.
Remember that when you restore a database file, it will replace the current da-
tabase, meaning that you will lose the data generated since the last time the last
restoration point was made.
It is advisable to always create a restoration point just before executing a restora-
tion of previous data.

Figure 104 Screen for restoring previous data

10.9.7.1. Programming export

Option to generate a file with the parameters of the test, calculated test, external
test, ISE test, calibrations and controls.
Select the name of the file and the location where you want to save it. The extension
of the generated file is .test

10.9.7.2. Programming Import

Option to import from a file the parameters of the test that have been saved pre-
viously. Keep in mind that when you accept the file, you will add the new test that
you do not have in the list of test and the changes to the existing test will be applied.
Select the location where the test file is located and the name to import it.

10.9.7.3. Audit trail

The application incorporates an audit system. This system memorizes any changes
made to the application that may affect the results.
Press this menu option to view the tracking of the changes.

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 To be able to perform an analysis of the data:
• Select the text to be analyzed.
• Copy it
• Paste it on a text editor (for example, Notepad ++). From the editor you can
perform searches in an easier way.

10.10. Help

10.10.1. User manual

In this menu you can open a copy of this user manual in pdf format. The pdf reader
(Reader®) can be installed directly from the DVD supplied with the equipment or
it can be downloaded from the adobe® website.

10.10.2. Analyser information

This option displays the instrument serial number and firmware version installed
in the analyser

10.10.3. About
This option displays the installed software version.

10.11. Exit
To exit the programme go to the exit menu and select one of the two options:
Exit with shut-down This option closes the programme and tells the analyser to switch itself off and
complete the closing process.
Exit without shut-down This option will only close the programme and leave the analyser on and on
standby.

10.12. Automatic RestorePoint generation utility

During a session reset an automatic RestorePoint is generated. RestorePoint are
kept for seven days (they may or may not be consecutive).
This allows the technical service to have detailed information in order to analyse
all problems occurring during the last seven days of operation.
The daily files are stored in the following folder:
C:\Users\[User ID]\Documents\BA200\RestorePoints
RestorePoint files are distributed in folders by days. Every folder contains all the
Sessions run within these day.

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11. List of consumables and accessories

In the event of any of the analyser components being damaged or if fungible goods
are required, always use original BioSystems material.
The following table shows a list of the components that might be needed. To
purchase them, contact your habitual dealer/distributor and ask for each element
with its respective code.

Accessories list
Code Representation Description
AC17274 DVD User and service programme

AC11 485 Reaction Rotor (10)

AC10 770 Sample wells (1000)

AC16 434 500 mL bottle of concentrated washing solution

AC17201 Bottle of acid washing solution

AC17205 Bottle of alkaline washing solution

AC16 360 Open adapter for primary tubes (90)

AC17611 Tube adapter (30)

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Accessories list
Code Representation Description
AC16 362 60 mL reagent bottles (20)

AC16 363 20 mL reagent bottles (20)

AC16 364 60 mL opaque reagent bottles (20)

AC16 365 20 mL opaque reagent bottles (20)

AC17269 Connection tubes for purified water bottle (3 m)

AC17270 Connection tube for waste (3 m)

AC17271 Washing solution bottle with cap

AC17272 High contamination bottle with cap

AC17273 Washing solution bottle cap

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Accessories list
Code Representation Description
AC16749 High contamination waste bottle cap

AC16 370 Reagent and samples rotor

AC11 486 Reaction rotor set screw

CA10 455 European mains cable

CA10 456 American mains cable

AC17305 USB cable for connection to the computer

AC16747 10 A (2) fuse

AC17097 150 µm purified water input filter assembly

AC16791 Water inlet filter assembly (5 µm)

AC16792 Spare water filter cartridge (5 µm)

List of ISE module accessories (optional)

Code Representation Description
5420 Reagent kit

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List of ISE module accessories (optional)
Code Representation Description
5625 Set of ISE module tubes

5201 Na+ electrode

5202 K+ electrode

5207 Cl- electrode

5205 Li+ electrode

5206 Separator electrode

5204 Reference electrode

5421 ISE module washing solution

5412 ISE module 125 mL urine dilution

5408 ISE module 500 mL urine dilution

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List of ISE module accessories (optional)

Code Representation Description
AC16752 ISE cleaning kit

AC17096 Cotton buds

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12. Support and warranty
The BA200 analyser is designed to perform biochemical and turbidimetric analyses.
Its operation is optimised for the BioSystems Reagents line. For information about
all the available measuring procedures please contact your habitual distributor.

12.1. Warranty limits

Any improper use (falls, negligence, electrical mains conditions outside the toler-
ances, unsuitable environmental or location conditions, etc.) as well as and any
manipulation of the analyser interior by persons not authorised by Biosystems
or using non-original consumables and spares (rotors, fuses, etc.) will render the
warranty invalid.

12.2. Technical assistance

Contact your habitual distributor for information about:
• Training in using the analyser
• After-sales Service Request Protocol
• Updating the User programme
You will find more information about the product in the Biosystems website:
http://www.biosystems.es

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13. List of alarms

Below is a list of errors shown by the programme and the resolution thereof by
the user:

Type of Alarm/Error Cause of the problem Solution proposed

alarm
Analyser Warning that the The main cover of the analyser has Close the cover and press the
alarms main cover of the opened while executing the work analyser recovery button. The
analyser is open list. This action blocks the work current work list will be lost.
list.
Warning that the The analyser cover has opened during When the warning is active it is
main cover of the the stopping phase. The program impossible to start or continue with
analyser is open sends a warning that the main cover the work list. Close the main cover.
of the analyser has opened.
Warning that The washing solution bottle is Replenish the washing solution
there is no empty. The analyser will complete bottle. Press the bottle change
washing solution the preparations already started confirmation button. The analyser
but not dispense any more will continue with the work list in
preparations. progress.
Warning The high contamination bottle is Empty the high contamination
that the high full. The analyser will complete the bottle. Press the bottle change
contamination preparations already started but not confirmation button. The analyser
bottle is full dispense any more preparations. will continue with the work list in
progress.
Error due to The arm has collided. This action Solve the cause of the collision.
collision of the will block the arm that has Check the state of the colliding
reagent and collided. The analyser recovers the reagent bottle or sample tube.
sample arm arm and continues processing the
preparations.
Warning The programme warns that there is Insert a fresh bottle of reagent on
that there is very little reagent R1 or R2. the rotor before starting the work
insufficient session.
volume of reagent
R1 or R2.
Warning The R1 or R2 reagent bottle is Press the pause button. When the
that there is empty. The programme will block program tells you to, access the
insufficient the next preparations that require reagent rotor and change the empty
volume of reagent that reagent. bottle. Press the continue button.
R1 or R2
Warning that The reagent rotor cover has opened Close the reagent rotor cover.
the reagent and during the stopping phase.
samples rotor
cover is open
Refrigeration off The programme warns that the Switches on the refrigeration system.
warning refrigeration system is off.

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Type of Alarm/Error Cause of the problem Solution proposed
alarm
The purified water The purified water tank has not Check that the water inlet
tank has been been filled for a long time. This configuration is correct. If there is
empty for too action blocks the work list. an external tank, check that it is full.
long Resolve the problem of the absence
of water and press the bottle change
confirmation button.
Warning that the The reaction rotor cover has Close the reaction rotor cover.
reaction rotor opened during the stopping phase.
cover is open
Warning that You have started a worklist without Insert a new reaction rotor with the
there is no a reaction rotor. rotor change utility.
reaction rotor
Error due to the The wash station has collided. This Check the correct positioning of the
reaction rotor action stops the work list. reaction rotor. Check that the wash
stopping station suspension is not blocked.
Press the recovery button. If the
alarm continues notify the technical
service.
Warning that The analyser has detected a Centrifuge the sample again.
a clot has been blockage in the sample tip.
detected
The analyser has a fluidic problem Check the connections and the
water inlet configuration. Check
that there is sufficient water in the
external tank.
Warning The sample or calibrator volume Press the pause button. When the
that there is is insufficient. The programme program tells you to, access the
insufficient sample blocks the next tests for the current sample rotor and replenish the
volume patient. sample physically and confirm it by
pressing the refilling button. Press
the continue button.
Warning of There is insufficient volume in the Press the pause button. Check the
insufficient rotor cuvette where the sample sample or diluent volume. Press the
volume in the dilution is prepared. The program continue button.
diluted sample blocks the diluted sample in
progress.
Error in adjusting Baseline adjustment values off Change the reaction rotor. Check
the baseline limits. This action is done with the that the wash station is operating
rotor change. correctly. If the alarm continues
notify the technical service.
Warning message Too many reaction rotor cuvettes Change the reaction rotor.
to change the rejected. This warning does not
reaction rotor block the execution of the work
list.

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Type of Alarm/Error Cause of the problem Solution proposed

alarm
Error warning There may be either debris or Clean the barcode reader window
in reading the moisture on the barcode reading with a cloth.
barcode optical window
Warning of a Communication A problem has occurred with the Check the communication cable.
failure in the error communications between the Press the connect button.
analyser computer and the analyser. Check that the COM port is not
being used by another programme.
Try to connect the cable to another
computer’s port.
Alarm saying the The reaction rotor temperature has Press the recovery button. If the
reaction rotor been off limits for too long. This alarm continues notify the technical
temperature is off alarm will not stop the work list. service.
limits
Alarm saying the The arm temperature has been off Press the recovery button. If the
arm temperature limits for too long. This alarm will alarm continues notify the technical
is off limits not stop the work list. service.
Alarm saying The refrigerator temperature has Close the reagent and sample rotor
the refrigerator been off limits for too long. This cover. Press the recovery button.
temperature is off alarm will not stop the work list. If the alarm continues notify the
limits technical service.
Alarm saying The wash station temperature has Press the recovery button. If the
the wash station been off limits for too long. This alarm continues notify the technical
temperature is off alarm will not stop the work list. service.
limits
Refrigerator fans The refrigerator rotor fans are not Notify the technical service.
damaged functioning properly.
The reaction rotor The reaction rotor fans are not Notify the technical service.
fans are damaged functioning properly.
Error in detecting The motor start detection device Press the recovery button. If the
the start of a has failed alarm continues notify the technical
motor service.
Reinitiating an An internal electronic board has been Press the recovery button. If the
electronic board reinitiated alarm continues notify the technical
service.
ISE module ISE module status ISE module installed but off Switch on the ISE module
alarms warning
ISE module status ISE module damaged Call the technical service
alarm
Module off for a long period Reactivate the module
Electrode alarm Electrode not installed Install a new electrode
Electrode not correctly positioned Check the electrode position
Waste pump not correctly Check the position of the peristaltic
positioned waste pump tubes
Reagent kit alarm Reagent kit not installed Install the reagent kit

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Type of Alarm/Error Cause of the problem Solution proposed
alarm
Reagent kit connector not correctly Check the reagent kit connector.
positioned
Warning that the The reagent kit has expired Change the reagent kit
reagent kit has
expired
Warning that Calibrator A or B has been used up. Change the reagent kit
calibrator A or B
of the reagent kit
has been used up
Warning that One of the electrodes has expired Change the expired electrode.
an electrode has
expired
Warning that the The number of uses necessary Change the electrode.
number of uses for for the correct operation of an
an electrode has electrode has been exceeded
been exceeded
Error in Insufficient sample in the ISE Check the sample volume and repeat
dispensing the module reader or air bubbles the sample.
sample detected
Slope value under Non-alignment of the electrodes Remove the electrodes. Inspect the
the established toric joint (O-ring)
limit Reinstall the electrodes.
The calibration solutions have been Replace the reagent kit
used up
End of the electrodes' useful life Replace the electrodes
Air bubbles in the reference Remove the electrode. Tap it several
electrode times to eliminate the air bubbles.
Reinstall the electrode. Recalibrate
Shunt from an This may occur if the electrode is Purge calibrator A and recalibrate
electrode new or calibrator A has just been
installed.
If the electrode is new, it may shunt
initially while rehydrating for 15
minutes.
End of the electrode's useful life Replace the electrode
Air in the sample Insufficient sample volume. Check that there is sufficient sample
and/or calibrator volume.
Check that the tip is not partly
blocked.
Loss of fluid Determine the leak.
Call the technical service.

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Type of Alarm/Error Cause of the problem Solution proposed

alarm
Sample not in position Electrodes not correctly sealed.
Remove the electrodes. Inspect the
O-ring and reinstall.
Change the peristaltic pump tubes.
Pump tubes blocked Change the pump tubes
Sample intake cup dirty Clean the cup with a cotton swab
and ISE Cleaning Solution. Fill the
inlet ISE cup with ISE cleaning
solution. Wait for several minutes to
allows pepsine to actuate. Purge and
prime for several cycles.
Fibrin or remains of salts are Apply the cleaning procedure
blocking the electrode flow path Remove the electrodes and clean or
change them. Reinstall the electrodes
and recalibrate
Air bubble detector damaged Notify the technical service
The waste pump is not working Check there is no type of blockage
within the internal ISE channel.
Deinstall the electrodes and check
their pathways by using a guidewire.
Install them again. If the problem
persists, notify the technical service
Results screen Contamination Very high concentration level in Separate the serum and urine
alarms determined in the serum compared to urine. samples to ensure they are not
protein in serum processed consecutively.
sample on the
protein in urine
Principal Abs > This message will appear for Check the reagent status, it may be
Blank Abs limit tests programmed as ascending damaged: this may be due to the
bichromatic endpoint tests. reagent expiry date being exceeded
This result indicates the status of or to poor conservation of the
the reagent. reagent.
Working Reagent This message will appear for Check the reagent status, it may be
Abs > Blank Abs tests programmed as ascending damaged: this may be due to the
Limit differential tests. reagent expiry date being exceeded
This result indicates the status of or to poor conservation of the
the reagent. reagent.
Initial Blank Abs This message will appear for tests Check the reagent status, it may be
> Blank Abs Limit programmed as kinetic or fixed damaged: this may be due to the
ascending time tests. reagent expiry date being exceeded
The initial blank Abs value is not or to poor conservation of the
used to calculate the concentration. reagent.
This result indicates the status of
the reagent.

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Type of Alarm/Error Cause of the problem Solution proposed
alarm
Principal Abs < This message will appear for Check the reagent status, it may be
Blank Abs limit tests programmed as descending damaged: this may be due to the
endpoint tests. reagent expiry date being exceeded
This result indicates the status of or to poor conservation of the
the reagent. reagent.
Working Reagent This message will appear for Check the reagent status, it may be
Abs < Blank Abs tests programmed as descending damaged: this may be due to the
Limit differential tests. reagent expiry date being exceeded
This result indicates the status of or to poor conservation of the
the reagent. reagent.
Initial Blank Abs This message will appear for Check the reagent status, it may be
< Blank Abs Limit tests programmed as kinetic or damaged: this may be due to the
descending fixed time tests. reagent expiry date being exceeded
The initial blank Abs value is not or to poor conservation of the
used to calculate the concentration. reagent.
This result indicates the status of
the reagent.
Kinetic blank > This message will appear for tests Repeat the blank.
Kinetic blank programmed as kinetic and fixed
limit time tests.
For descending reactions
calculation of the kinetic blank
will be converted into positive, to
correctly compare it with the limit.
It is used to check that the blank is
correctly executed.
Incorrect curve For an ascending calibration Repeat the different calibration
curve: all the absorbance points curve points.
must be in ascending order as the
concentration increases
For a descending calibration curve:
all the absorbance points must
be in descending order as the
concentration increases
Factor calculated The factor value is outside the Repeat the calibration.
off limits limits entered in programming the
test
Calibration factor The calibrator absorbance is lower Repeat the calibration.
NOT calculated than the blank absorbance.
It was not possible to calculate the
calibrator absorbance.
It was not possible to calculate the
blank absorbance.
The calibrator absorbance has
exceeded the photometric limit
>3.5

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Type of Alarm/Error Cause of the problem Solution proposed

alarm
CONC outside The concentration value was Repeat the test to ensure the sample
the normal range outside the normal range defined in is pathological.
programming the test.
CONC <0 The sample absorbance is lower Repeat the test. If the blank value is
than the blank absorbance. memorised, repeat the blank.
CONC > linearity The concentration value has Repeat the test diluting the sample.
limit exceeded the linearity limit. The process can be automated.
Activate in programming the
automatic postdilution and enter a
value for the linearity limit.
CONC < The concentration value is lower Repeat the test increasing the sample
detection limit than the detection limit. concentration. The process can be
automated. Activate in programming
the automatic postdilution and enter
a value for the detection limit.
CONC outside Extrapolated result, the Repeat diluting the sample.
the calibration concentration Abs is outside the
curve calibration curve.
Conc NOT It was not possible to calculate the Repeat the test for the sample, blank
calculated blank absorbance. or calibrator, depending on the
It was not possible to calculate the problem.
sample absorbance.
It was not possible to calculate the
factor.
Calibration curve incorrect.
Sample substrate This message will appear for tests Repeat the test diluting the sample.
depletion programmed as kinetic. The process can be automated.
If the message appears this means Activate in programming the
that the substrate was consumed automatic postdilution and enter
before the reaction started. This a value in the consumed substrate
happens in samples with very high field.
concentrations.
Sample possibly This message will appear for tests Repeat the test diluting the sample.
affected by programmed as turbidimetric.
prozone If the message appears it means that
the sample concentration may have
the prozone effect.

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14. Maintenance and cleaning

14.1. Maintenance activities and frequency

The following table shows the maintenance activities and the frequency with which
they should be executed.

Activities at the start of the day

1 Replenish the washing solution bottle
2 Start up the analyser. Perform the warm-up with the programme
3 Execute 2 conditioning cycles
4 Check the temperature of the reaction rotor and the reagent rotor
5 Check the reagent volume
6 Calibrate the ISE module peristaltic pumps
7 Calibrate the ISE electrodes

Activities at the end of the day

1 Wash the ISE module channel with the washing solution
2 Switch off the analyser by executing the Shut-down with the
programme
3 Empty the high contamination bottle
4 Remove the calibrators, controls and samples from the rotor

Activities to be executed every week

1 Change the reaction rotor
2 Clean the working surface
3 Clean the interior of the reagent and sample rotor vessel
4 Clean the stirrer paddle with a cloth soaked in washing solution
5 Check the capacity of the ISE module reagent pack and replace it, if
used up
6 Rinse the ISE module waste tubes with distilled water
7 Calibrate the ISE module air bubble detector
8 Clean the ISE module inlet cup with a cotton bud

After performing any maintenance operation, make sure that the instrument is
in the correct installation conditions for its operation.

NOTE

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14.2. Cleaning the analyser

14.2.1. General cleaning of compartments

Use a damp cloth and neutral soap to clean the analyser surfaces and the internal
compartments of the rotor.

14.2.2. Emptying and cleaning the high contamination waste bottle

The high contamination waste container is supplied with a fast connector fitting.
1. Press the fast connection fitting on the cap and take the container out of the
analyser.
2. Unscrew the container cap.
3. Empty the container.
4. Screw on the container cap, insert the tube with the fast connector and place
in the container in its housing inside the analyser.
Make sure that the fast connector fitting is properly inserted into the container
cap. To do this, when inserting the fitting, you should hear a “click”. If not, this
NOTE means it has not been properly inserted.
Dispose of the waste in accordance with the applicable national or local govern-
ment legislation governing the disposal of dangerous biological waste.
Handle the high contamination waste container with care. Wear gloves and protec-
tive clothing when handling the container.
BIOHAZARD

14.2.3. Cleaning the sample and reagent rotor

In the event of spills inside the rotor housing when handling the samples or rea-
gents proceed as follows:
1. Turn off the analyser.
2. Wear gloves and protective clothing when cleaning spills.
3. Remove the sample and reagent rotor.
BIOHAZARD
4. Mop up the spilled substance with a damp cloth.

14.2.4. Removing of condensation water from the reagent rotor

As the reagent rotor is always connected and refrigerated, condensation may form
on it. There is a drainage hole to empty the water resulting from excess condensa-
tion. In the event of detecting that the reagents are not refrigerated sufficiently,
mop up all excess condensation with a cloth.

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14.2.5. Cleaning the barcode reader window
If the programme reports a high number of errors in reading the barcodes, check
the status of the barcode reading window.
1. Turn off the analyser.
2. Remove the reagent and sample rotor cover.
3. Take out the rotor.
4. Clean the interior window with a damp cloth.

14.2.6. Filling the washing solution bottle

1. Unscrew the cap of the washing solution bottle
2. Fill it with 2.4 L of purified water.
3. Add 12 mL of the concentrated washing solution (AC13 434 code). Take care
in handling the concentration washing solution bottle, to prevent the contents
from splashing or spilling. Wear gloves and protective clothing when handling
NOTE it.
4. Screw on the cap with the tube and place it in its housing inside the analyser.
Plug the fast connector into the cap and ensure it clicks into place.
5. Press the washing solution filling button that tells the analyser to prime the
system.

14.2.7. Cleaning the stirrer paddle

1. Turn off the analyser by operating the switch.
2. Raise the stirrer arm manually. When moving the arms, do it gently and
carefully.
3. Clean the stirrer paddle with a cloth soaked in washing solution.
4. Rinse the stirrer with a cloth dampened with distilled water.
5. Lower the stirrer to its rest position.
6. Switch on the analyser and perform 2 conditioning cycles in the functions
menu.

14.2.8. Cleaning the water inlet filters

1. Turn off the analyser.
2. Access the rear part of the analyser where the water inlet filters are located.
))See Figure 105
3. Using a spanner, unscrew the water inlet filter support (1).
4. Clean the filter with water and a neutral soap (2).
5. Replace the filter and support.

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Figure 105 Dismantling the water filters

14.2.9. Cleaning the ISE module

Washing the ISE module channel The ISE module fluid transport system must
be cleaned at the end of the day or after processing 50 samples.
1. With the user program in the ISE utilities section, perform 1 wash cycle.
2. Position a sample tube with at least 300 µL of washing solution (5421) in
the sample rotor. Do not use any other cleaning agent such as tensioactives,
emulsions or buffers, as they could damage the electrodes.
3. Indicate in the programme the rotor position in which you have placed the
tube. Execute the instruction. The analyser will automatically dispense 300 µL
into the module cup for performing the cleaning operation.
4. After completing the activity store the cleaning agent in the refrigerator.
The software will also request the automatic cleaning of the ISE module after
processing 50 samples.
Cleaning of sample intake Use a cotton swab and ISE washing solution (5421) once a week.
))See Figure 106 and Figure 107
Place the swab at the module entrance and use it to rub the exterior and interior
of the intake cup (2). To see the cup intake, remove the plastic part located at the
base of the stirring arm (1).

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 1

Figure 106 Access to the ISE cup

Figure 107 ISE cup

Cleaning the ISE To prevent blockages of the ISE module waste tube due to poorly coagulating
module tubes samples, proceed as follows to clean the waste tube:
1. Remove the ISE module waste tube from the peristaltic pump housing.
2. Separate the yellow L-shaped part from the bottom part of the module.
3. Use commercial bleach. Check that it has a sodium hypochlorite concentra-
tion of between 5 and 6%.
4. Fill a syringe with 5 mL of bleach and connect it to the L-shaped connector
that was previously removed.

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5. Slowly inject the syringe to fill the waste tube with the bleach. Let the bleach
act inside the tube for 6 minutes.
6. Remove the syringe from the L-shaped connector and fill it with distilled water.
7. Reinsert the syringe into the L-shaped connector and rinse out the waste circuit.
8. Remove the syringe from the L-shaped connector and plug the L-shaped
connector into the module.
9. Replace the waste tube in the peristaltic pump.
10. Execute a couple of priming operations with CAL A.

14.3. Maintenance

14.3.1. Changing the reaction rotor

The analyser automatically makes an optical reading before using each rotor cuvette,
to determine its state. If the reading exceeds certain levels, the cuvette is discarded
and not used. The program informs about the cuvettes that have been discarded. If
several cuvettes are repeatedly discarded it is advisable to change the reaction rotor.
It is recommended to change the reaction rotor at least every week.
Steps for changing the rotor
NOTE 1. Go to the functions menu and execute the change rotor option. Press the button
for raising the wash station in order to remove the rotor cover.
2. Remove the reaction rotor cover. Take care not to touch the tips of the wash
station with the cover.
3. Remove the central screw that secures the rotor.
4. Take out the rotor. Handle it with gloves and protective clothing.
5. Treat the rotor as biological waste.
6. Take a new rotor from the accessory box.
7. Insert the rotor in its housing.
8. Tighten the screw as far as it will go.
9. Replace the reaction rotor cover.
10. Press the finalise button in the change rotor option of the user programme.

14.3.2. ISE module maintenance

14.3.2.1. Changing the electrodes

Reference electrode The reference electrode is submerged in saturated KCL solution. If the concen-
tration of the reference electrode falls below 3.0 M (molar), the ISE measuring
module may give erroneous results. The reference electrode tanks has a small red
ball which normally floats on top of the filling solution. If the ball starts to sink
the reference electrode must be replaced.

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 Unpack the reference electrode. Remove the wire that has a yellow label (keep the
wise in case you need to turn off the module and store the electrode for a long time).
Ensure that there are no accumulated salts at the ends of the measuring channel.
Other electrodes Unpack the new electrode. Remove the adhesive tape that protects the fluid
transportation channel. Check that the rubber seal in the opening is in place. If
there is no rubber seal, put it back in its position. Each box of spares has pair of
seals, in case one is lost.
Proceed as follows to replace the electrode (both the reference and the other
electrodes)
1. With the user programme in the ISE utilitiessection, perform 1 Maintenance
cycle, to empty the ISE module channel.
2. Turn off the ISE module power supply.
3. Open the doors and remove the front cover of the ISE module.
4. Press the yellow button down to release the pressure in the electrodes.
5. Remove all the electrodes.
6. Discard the electrode that must be changed.
7. To put the electrodes back in position, press the yellow button down and
first insert the reference electrode and then the other electrodes, in the order
shown in Figure 108.
8. If there is no Li+electrode, put an empty electrode in its place, to ensure con-
tinuity in the channel through which the sample flows.
9. Release the yellow button to supply pressure to all the electrodes and ensure
good fluid communication.
10. To ensure that the electrodes are properly placed, press them at the front until
you hear a click or they have been correctly seated.
11. Turn on the ISE module power supply.
12. Put the front cover back in position and close the doors.
13. With the user programme, execute the actions in the number and order in-
dicated in the ISE functions, change electrodes section.

Step Action Repetitions Description

1 Priming B 1 Check, through the window exposed
after removing the stirrer cover, that the
ISE cup is being filled and emptied in
succession

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Step Action Repetitions Description

2 Priming A 1 Check, through the window exposed
after removing the stirrer cover, that the
ISE cup is being filled and emptied in
succession.
If an error is shown on the results screen,
perform the first two actions again. If
the problem persists, check that the
electrodes are properly positioned and
have been correctly inserted. If necessary,
take them out and put them in again.
Remember that the procedure for
removing them and reinserting them
must be carried out with the ISE module
power supply off.
3 Calibrate 1
the pumps
4 Activate the 1 Indicate the installation date. If none of
electrodes the electrodes has been replaced register
the old electrode again with the original
installation date
5 Prime B 1
6 Prime A 1
7 Calibrate 1
the
electrodes
8 Wait 5
minutes

Perform the last 4 actions 3 times. If the calibration is not satisfactory, wait 5
minutes and repeat the last 4 actions.

LI+
Na+
K+
Cl−
REF
WASTE

Figure 108 Order for positioning the different electrodes

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14.3.2.2. Changing the reagent kit
Open the front door and you will see the ISE module reagent kit on the left.
Remove it from its housing and take the connector out of the packet. Press the
yellow button to separate the kit from the connector.
Dispose of the waste in accordance with the applicable national or local govern-
ment legislation governing the disposal of dangerous biological waste. Do not
perforate or open the reagent kit.
BIOHAZARD
Check that the new kit is from a zone with room temperature similar to that of
the analyser.
Unpack the kit and remove the three red protective caps. Do not press the side of
the kit after removing the caps as the solutions it contains could flow out. Have
some paper at hand to dry the surface where the connector is coupled in case any
liquid flows out.
Position the connector in the correct direction and press lightly until you hear a
click. Write the installation date on the side of the kit.
Place the kit in its housing.
With the user programme, execute the actions in the number and order indicated
in the ISE utilities, change reagent kit section.
))See chapter 10.9.3

Step Action Repetitions Description

1 Activate 1 If the execution icon is not activated after
the selecting this option, check that it is a new
reagent kit. If the kit has already been activated
kit before, this option will not be available,
but you can make a reading with the Read
reagent Kit option. In this case, go on to
the next instruction. In the event that it
is a new kit, check that the connector is
correctly positioned, remove it again and
reconnect it.
2 Purge B 3 Remove the lower cover of the stirrer,
which allows you to observe the dispensing
cup.
))See Figure 106
Observe the cup and check the emptying
operation, i.e., that every time the module
pumps dispense the liquid into the cup,
it is emptied before the next dispensing
operation. If the pumps do not dispense
the liquid, execute the above action again.
If, after repeating the action 4 times,
no liquid is dispensed, disconnect and
reconnect the kit adapter and repeat the
action.
3 Purge A 3 Proceed as described above

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Step Action Repetitions Description

4 Priming B 9 Execute 9 repetitions of this instruction
to ensure the solution in the new kit
completely replaces the one in the
previous kit throughout the whole tube
and electrode circuit. Some of the error
repetitions may indicate absence of
liquid. Ensure that the three last priming
operations have been completed correctly.
If not, execute the necessary priming to
achieve this.
5 Priming 9 Proceed as described above
A
6 Calibrate 2 Execute this action to calibrate the
the electrodes with the new solution and
electrodes check it is in good condition. If the result
is unacceptable due to the presence of air,
check that the solutions are circulating
correctly and repeat steps 2 or 3,
depending on the error reported. If the
calibrations have ended but the results are
not acceptable, repeat these instructions a
couple of times.

14.3.2.3. Changing the peristaltic pump tubes

Open the front doors and take off the front cover of the ISE module.
It empties the tubes.
1. With the user program in the ISE utilities section, perform 5 Maintenance
cycles, to empty the channel and the tubes.
Remove the tubes from each of the peristaltic pumps. Release the pressure from
the head by pulling the clamp marked in yellow.
Separate each of the three tubes at the two joints and discard them. Wear gloves
when handling the tubes. Treat this material as potentially infectious. Dispose of
the waste in accordance with the applicable national or local government legisla-
BIOHAZARD tion governing the disposal of dangerous biological waste.
Unpack the new tubes.
Insert a tube into each peristaltic pump. To insert the tube into head of the peri-
staltic pump release the pressure on the head by pulling the clamp (1) upward,
see Figure 109.
Each tube has two labels. The labels help guide the tube correctly in the peristaltic
pump. The number on the label of each tube must coincide with the number on
the pump label.
• The tubes marked A must be installed in the pump (2). The order for putting
them in place starting from the bottom is A2 and A1.

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• The tubes marked B must be installed in the pump (3). The order for putting
them in place starting from the bottom is B2 and B1.
• The tubes marked W must be installed in the pump (4). The order for putting
them in place starting from the bottom is W1 and W2.

1
2
3

Figure 109 Connecting the peristaltic pump tubes

Take care when connecting the tubes of the waste pump (4) as they are connected
in reverse order to the tubes of the pump for calibrators A (2) and B (3).
With the user programme, execute the actions in the number and order indicated
in the ISE utilities, change pump tube section.
))See chapter 10.9.3

Step Action Repetitions Description

1 Priming 2
B
2 Priming 2
A
3 Priming 9
B
4 Priming 9
A
5 Update 1 Update the tube installation date
the instal-
lation
date
6 Calibrate 1 Execute this action to calibrate the
the pumps. If the result is not acceptable due
pumps to the presence of air, check the correct
installation of the tubes and repeat the
operations described above.

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14.3.2.4. Turning off the ISE module for a long period of time
If the analyser is not to be used for a long period of time, for instance, during the
holiday period, proceed as follows to conserve each electrode, tube and reagent kit.
To leave the module inactive, uninstall the electrodes and the reagent kit and clean
the tubes to prevent salts or traces of serum from blocking the circuit.
Execute the actions in the number and order indicated in the user programme,
in the ISE utilities section.
))See chapter 10.9.3
Step Action Repetitions Description
1 Filling 3 This action dispenses 300 µl of solution
with Cal A into the module cup. Use the syringe
A and long tip supplied with the accessories
box to suction the liquid and deposit it in
a sample well or in any other container.
Repeat this action 3 times. This solution
will be used to fill the electrode channel in
the storage procedure.

2 Wash 1 Place the washing solution in the

indicated sample rotor well
3 Purge A 3
4 Install the 1 Remove the reagent kit and put the cleaning
cleaning pack in its place, filled with purified water.
pack The pack is comprised of the base, 3 tubes
and the bottle. These elements are in the
AC16752 spare part .
))See Figure 110 on how to install the cleaning
pack.
5 Purge A 3
6 Purge B 3
7 Prime A 20 Execute these actions to wash the entire
fluid circuit thoroughly with purified water.
8 Prime B 20
9 Mainte- 1 Procedure for emptying the electrode
nance channel and uninstalling them without
damaging the module.
10 Deacti- 1 Procedure for telling the programme that
vating the module has been disconnected.
the ISE
module

Turn off the ISE module power supply.

Remove all the electrodes from the module, including the reference electrode.
Protect them as follows:

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 Na+ and Cl-electrodes Place each electrode separately in a sealed bag.
Reference electrode Reinsert the wire with the yellow label it into the reference electrode opening
and then place it in an individual sealed bag.
K+ and Li+electrodes K+ and Li+ electrodes Suction a small quantity of the calibrator A dispensed
in a sample well during the first step.
Inject the appropriate quantity of calibrator A into the channel of the K+ and
Li+ electrodes until the liquid fills the channel.
Cover the two ends of the channel (both sides of the K+ and Li+electrodes) with
adhesive tape to hold calibrator A in place.
Place the K+ and Li+ electrodes in a sealed bag.
Reagent kit Remove the reagent kit from the analyser and dispose of it.
Peristaltic pump tubes Remove all the tubes from the fluids and rinse them with purified water. Use
the syringe with the medium tip.
Thin tubes Rinse the thin tubes with purified water. Use the syringe with the small sized
tip.

Figure 110 ISE washing bottle

14.3.2.5. ISE module reactivation

• Remove all the electrodes from the sealed bags.
• Remove the tape from the K+ and Li+ electrodes and dry the electrode surface.
• If necessary, submerge the reference electrode in warm water until all salt in
the electrode opening channel has been dissolved.
• Install the electrodes in the ISE module.
• Reconnect the reagent kit with the ISE module.
• Turn on the ISE module power supply.
• Perform the steps described in section 4.13

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14.3.3. Maintenance frequency

The frequency for changing the ISE module elements is described below.

Element Users with a low ISE Users with a high ISE

sample volume sample volume
(> 100 samples/day)
Li+ electrode 3 months 3000 samples
Na+ electrode 6 months 10,000 samples
K+ electrode 6 months 10,000 samples
Cl- electrode 6 months 10,000 samples
Reference electrode 6 months 10,000 samples
Peristaltic pump 6 months 6 months
tubes
Fluidic tubes 12 months 12 months

14.3.4. End of the analyser's useful life

At the end of the useful life of the analyser dispose of the product in accordance
with the environmental legislation existing in each country. If that country is an
EU member state, the terms of the WEEE directive on electrical and electronic
appliances will apply. In other words, when the appliance's useful life has ended,
it is converted into waste and must be separated from household waste for correct
recycling. For this purpose, contact your habitual distributor for them to execute
the recycling.
Use gloves to manipulate any part of the analyzer that has been in contact with
biological material: tips, containers, tubes, etc.
Dispose of this material in accordance with current legislation for the disposal of
BIOHAZARD hazardous biological waste from your national or local government.

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15. Technical characteristics

15.1. General characteristics

Speed 200 prep/h (without
electrolytes)
Combined ISE module speed 267 prep/h with 3 channels
300 prep/h with 4 channels
Analysis principles Photometry, turbidimetry.
ISE module: Direct power meter
Analyser type Random access
Continuous sample loading

15.2. Sample and reagent management

Sample and reagent rotor capacity 88 (44 bottles of 20 mL or
60 mL + 44 bottles of 20 mL)
Barcode detector Yes
Number of samples with barcodes 88
Size of primary tubes Diameter 12 mm to 16 mm
(max. height 100 mm)
Sample well Sample well diameter 13.5 mm
Reagent bottle volume 20 mL, 60 mL
Refrigerated reagents Yes
Refrigerator temperature range 6 °C to 11 °C (at room
temperature of 21 °C)
Type of sample pump syringe Low-maintenance ceramic
piston
Piston diameter 8 mm
Dispensed sample volume 2 mL to 40 mL
Dispensing resolution 0.1 mL
Dilution ratio 1:1 to 1:200
R1 reagent volume 90 mL to 300 mL
R2 reagent volume 10 mL to 100 mL
Dispensing resolution 0.1 mL
Level detection Yes
Washing of tip Interior and exterior
Clot detector Yes
Vertical collision detector Yes
Thermostatted tip Yes

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15.3. Reaction rotor

Minimum reaction volume 180 mL
Maximum reaction volume 440 mL
Number of cuvettes 120
Cuvette material UV methacrylate
Type of incubation Dry
Dispensing time for second reagent 5 min (fixed)
Reaction cuvette temperature 37 °C
Accuracy of the temperature ±0.2 °C
Temperature stability ±0.1 °C
Stirrers 1

15.4. Cuvette washing system

Number of washing system tips 7
Number of tips with washing solution 2
Rinsing with water 3
Drying 2
Wash volume per tip 711 mL
Washing solution consumption 1.42 mL/cycle

15.5. Optical system

Light source LED+Hard Coating Filter
No. of wavelengths 8
Wavelengths 340­­– 405 – 505 – 535 – 560 –
600 – 635 – 670 nm
Filter band width 10 nm ± 2 nm
Wavelength accuracy ± 2 nm
Photometric range -0.2 A to 3.5 A
Internal resolution 0.0001
Detector Principal photodiode +
reference photodiode
Measurement precision (for 340 nm, CV < 1% at 0.1 A
405 nm and 505 nm) CV < 0.1% at 2 A

15.6. ISE module (optional)

Sample type Serum, Plasma or Urine
Type of electrode Na+, K+, Cl-. Li+ (optional)

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 Type of measurement Direct ISE
Sample volume Serum: 100 mL
Urine: 200 mL

15.7. Environmental requirements

Room temperature 10 °C to 35 °C
10 °C to 30 °C (with ISE
module)
Relative humidity < 85% with no condensation
Maximum altitude < 2 500 m
Contamination grade 2
Transportation and storage temperature 0 °C to 40 °C
Transportation and storage humidity < 85% with no condensation

15.8. Dimensions and weight

Dimensions (Width, depth and height) 1077 mm x 690 mm x
680 mm
Weight 166 Kg

15.9. Electrical requirements

Mains voltage 115 V to 230 V
Network frequency 50 Hz or 60 Hz
Electric power 500 VA

15.10. Fluid requirements

Water inlet Through external tank or
through direct connection
Type of water Purification type II (NCCLS)
Water consumption < 9 L/h
High contamination waste tank Internal, 2.4 L
Washing solution tank Internal, 2.4 L

15.11. Minimum computer requirements

Operating system Windows® 7 (x64)
Windows® 10 (x64)

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CPU Equivalent to Intel Core

i3 @3.10 GHz or higher
RAM memory 4 Gbytes
Hard disk 40 Gbytes or more
DVD player Yes
Monitor Minimum resolution
1 024 x 768
Serial channel connector USB

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16. Measuring and calculation procedures
This chapter describes the different analysis modes of the analyser and the calcula-
tions made to obtain the analytical results, i.e., the concentration values of the dif-
ferent sample analytes. The different formulae used are indicated in each case. The
controls are treated in the same way as the patient samples in all the calculations.

Symbols used in the formulae

Symbol Description
ABS Absorbance value read in one instant of the reaction.
A Absorbance value calculated based on the chosen analysis
mode.
[...]λprincipal Absorbance value at the main wavelength.
[...]λreference Absorbance value at the reference wavelength.
[...]L1 Absorbance value in time L1
[...]L2 Absorbance value in time L2
DABS Increase in absorbance
VM Sample volume
VR1 Volume of reagent 1
VR2 Volume of reagent 2
C Analyte concentration
F Factor
ABlank Blank absorbance
ACalibrator Calibrator absorbance
Asample Sample absorbance
Ccalibrator Known calibrator concentration

16.1. Operating sequence. Preparation and reading cycles

Figure 111 shows the dispensing cycles, the dispensing of reagents 1 and 2 and
the reading made by the analyser.
Each analyser cycle lasts for 18 seconds. The total maximum reading time for a
preparation may last for 10.2 minutes.
The cycle for dispensing reagents 1 and 2 and the sample is fixed. All that is pro-
grammed is whether or not the second reagent is dispensed and the times for the
readings or reading intervals (kinetic) L1 and L2.

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R1+S L1 R2 L2 WS1 WS2

Figure 111 Analyser cycles

Abbreviations Cycles Description

R1+S 1 Dispensing of reagent 1 and sample
M1 2 Stirring reagent 1 and sample
L1 2-18 Reading
R2 18 Dispensing of reagent 2 (optional)
M2 19 Stirring of reagent 2
L2 18-35 Reading (L2 > L1)
WS1 36 Wash station initiation
WS2 46 Drying cycle initiation

16.2. Calculation of the absorbances

The absorbance calculation depends on the programmed analysis mode.
The analyser has the following analysis modes:

Analysis mode
Endpoint monoreagent
Endpoint bi-reagent
Differential switch
Fixed time monoreagent
Fixed time bi-reagent
Kinetic monoreagent
Kinetic bireagent
Each of the analysis modes executed by the analyser is shown below in detail, with
a graphic interpretation of the dispensing and reading points and the calculation
made to obtain the absorbance.
Each of the above analysis modes may be ascending or descending.
If the test is ascending, the evolution of the absorbance increases depending on
the time. It has an ascending form.
If the test is descending, the evolution of the absorbance decreases depending on
the time. It has a descending form. To obtain positive absorbance values using
these calculation methods, the result is multiplied by -1.

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16.2.1. Endpoint monoreagent
In endpoint reactions, once initiated the reaction lasts until it is balanced and then
the absorbance value remains stable. The absorbance reading is programmed at
this point. See Figure 112.
First reagent A is dispensed and the sample is dispensed in cycle 1, it is stirred and
the reaction commences. Once it is balanced, the reading is taken, L1. The change
in absorbance is directly proportional to the analyte concentration.

 !"

f
ormul
a1-
ENG





formula2-ENG

  
 

Figure 112 Endpoint monoreagent calculation method representation

The absorbance reading can be made at one wavelength (monochromatic) or two

wavelengths (bichromatic).
Bichromatic readings are normally used to eliminate the influence of the cuvette
in the absorbance reading.
If the reaction is monochromatic, the measurement is taken in time L1 at one
wavelength.

A=ABSλL1main

(1)

If the reaction is bichromatic two readings are made in time L1. Each of the read-
ings is made with a different wavelength. The absorbance is the difference between
the two wavelengths.

A= ABS L1main− ABS L1reference (2)

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16.2.2. Endpoint bi-reagent

This operating mode is used, for example, if the working reagent stability is very
short, in such a way that it is the analyser that prepares the working reagent in
each preparation.
In this calculation mode a single reading is made and the reaction starts when the
second reagent is dispensed.
Firstly, reagent A is dispensed and the sample in cycle 1, and in the next cycle it is
stirred. Then reagent B is dispensed in cycle 18 and stirred and the reaction com-
mences. Once it is balanced, the reading is taken, L1. The change in absorbance
is directly proportional to the analyte concentration.
f
ormu l a1- E!NG





formula2-ENG 




 



Figure 113 Endpoint bi-reagent calculation method representation

The absorbance calculation may be monochromatic or bichromatic.

If the reaction is monochromatic, the measurement is taken in time L1 at one
wavelength.

A=ABSλL1main (3)

If the reaction is bichromatic two readings are made in time L1. Each of the read-
ings is made at a different wavelength. The absorbance is the difference between
the two wavelengths.

A= ABS L1main− ABS L1reference (4)

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16.2.3. Differential switch
Differential tests make two readings, the first one before dispensing reagent B
and the second one after the end of the reaction. These tests are used to eliminate
potential turbidity effects in the sample, or eliminate the potential absorbance
levels of reagent A.
First reagent A is dispensed and the sample in cycle 1, in the next cycle it is stirred
and the reaction commences. Before dispensing reagent B, the L1 reading is taken.
Reagent B is dispensed in cycle 18, and stirred in the next cycle, and the second
part of the reaction commences. When the second reaction is balanced, reading
L2 is taken.

f
ormul

 a5-
ENG








   
 

Figure 114 Differential calculation method representation

The following formula is applied in calculating the absorbance:

V M +V R1 (5)
A=ABSλL2main−(ABSλL1main∗ )
V M +V R1+V R2

16.2.4. Fixed time monoreagent

In tests programmed with the fixed time calculation method, the reaction speed
is directly proportional to the consumed substrate. As the substrate is consumed
the reaction speed is reduced, leading to a change in the absorbance. Thus, in a
fixed time interval the change in the substrate concentration is directly propor-
tional to the initial concentration. In the time interval, the change in absorbance
is proportional to the analyte concentration.
In this calculation mode two readings are taken and the resulting absorbance is
the difference between both readings.

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First reagent A is dispensed and the sample is dispensed in cycle 1, it is stirred and
the reaction commences. Reading L1 is taken and after a few cycles reading L2 is
taken. The absorbance is the difference between the readings.


 !
formula6


formula21-ENG
"





 "  
 

Figure 115 Fixed time monoreagent calculation method representation

The absorbance calculation may be monochromatic or bichromatic.

If the reaction is monochromatic, it is only measured at one wavelength and the
absorbance calculation is performed with the following formula:

A= ABS L2− ABS L1 (6)

If the reaction is bichromatic, two readings are made at time L1 and two readings
at time L2. The absorbance is the difference between the two wavelengths at reach
reading time.

A= ABS L2main − ABS L2reference − ABS L1main− ABS L1reference  (7)

16.2.5. Fixed time bi-reagent

In this operating mode it is the analyser that prepares the working reagent in each
preparation.
Firstly, reagent A is dispensed and the sample in cycle 1, and in the next cycle it
is stirred. Then reagent B is dispensed in cycle 18 and stirred and the reaction
commences. Reading L1 is taken and after a few cycles reading L2 is taken. In
this calculation mode two readings are taken and the resulting absorbance is the
difference between both readings.

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 The absorbance calculation may be monochromatic or bichromatic.
If the reaction is monochromatic, it is only measured at one wavelength and the
absorbance calculation is performed with the following formula:

A= ABS L2− ABS L1 (8)

If the reaction is bichromatic, two readings are made at time L1 and two readings
at time L2. The absorbance is the difference between the two wavelengths at reach
reading time.

A= ABS L2main − ABS L2reference − ABS L1main− ABS L1reference  (9)

 










A={%ABS}_L2-{%ABS}_L1
  # !"
 

Figure 116 Fixed time bi-reagent calculation method representation

16.2.6. Kinetic monoreagent

In tests
A=({%ABS}^{%lambda programmed with the kinetic calculation
main}_L2-{%ABS}^{%lambda mode, the reaction speed is
reference}_L2)-({%ABS}^{%lambda
maintained constant during the reaction process. As a result the absorption of the
main}_L1-{%ABS}^{%lambda reference}_L1)
analytes at a certain wavelength changes uniformly and the change in absorbance
per minute (DABS/min) is directly proportional to the concentration of the ana-
lytes. The kinetic method is used to measure enzymatic activity.
For this calculation mode an initial and an end time are programmed. Between
these two times several readings are taken and the linear regression of the readings
is calculated. The resulting absorbance is the linear regression slope value.
In addition the linearity of the readings is checked; to do this, the correlation
coefficient is calculated.

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If the correlation coefficient r < 0.9 then the programme says that the result of
the kinetic reaction is non-linear.
First reagent A is dispensed and the sample is dispensed in cycle 1, it is stirred
and the reaction commences. The analyser starts to take the readings from time
L1 to time L2.
The absorbance calculation is as follows:

 main
(7)
A= [
 ABS
min ]
 








!

 !  
 

Figure 117 Kinetic calculation method representation

16.2.7. Kinetic bireagent

A=left [{{%DELTA %ABS} over min}right ]^{%lambda main}
In this operating mode it is the analyser that prepares the working reagent in each
preparation.
Firstly, reagent A is dispensed and the sample in cycle 1, and in the next cycle it
is stirred. Then reagent B is dispensed in cycle 18 and stirred and the reaction
commences. The analyser starts to take the readings from time L1 to time L2.

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 formula9-ENG
 











  ! 
 

Figure 118 Kinetic calculation method representation

The absorbance calculation is as follows:

 main

A= [
 ABS
min ] (7)

16.3. Concentration calculation

To determine the analyte concentration of a sample, its absorbance must be calcu-
lated using any of the above analysis modes, and a calibration function must be used.
Calibration function It establishes a ratio between the calculated absorbance values and the known
sample analyte concentrations. This ratio may be linear or non-linear.
To calculate the calibration function one or several samples with a known analyte
concentration are measured and a calibration curve is obtained. See Figures 111
and 112. If the ratio is linear only one calibrator is measured and the calibration
line is calculated. If the ratio is non-linear several calibrators will be needed and
the calibration curve will be calculated with a regression procedure. It also meas-
ures the blank that will be the signal measured by the analyser in the absence of
the analyte. In the calibration curve the blank will correspond to concentration
point equal to zero.
Blank The blank is the absorbance in the absence of the analyte. It is measured using a
sample that contains no analyte. In general, purified water is used as the sam-
ple, but physiological saline solution can also be used. To correctly measure the
reagent blank absorbance, the same analysis mode must be used as the one used
with the samples.

A=left [{{%DELTA %ABS} over min}right ]^{%lambda main}

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Calibrator The calibrator is a sample with the known concentration of the analyte to be de-
termined. It is a standard or reference material. To correctly measure the calibra-
tor blank absorbance, the same analysis mode must be used as the one used with
formula10-ENG
the samples.
If the ratio between the analyte absorbance and its concentration is linear, then
the calibration function is a line. So it will only be necessary to measure the blank
and a calibrator.
ABS

Acalibrator

Asample

Ablank

Csample Ccalibrator CONC

Figure 119 Linear calibration curve

For the linear standard functions the blank absorbance ordinates is taken as the
source and the inverse of the factor as the slope.
The factor is calculated as follows:

C standard
F=
A standard − Ablank (8)

And the following formula is used to calculate the concentrations:

Csample= F*(Asample-Ablank) (9)

For calibration functions that are non-linear several known concentration calibra-
tors are used, approximating the curve with regression functions.
The following regression functions can be programmed:

Type of function Description

Polygonal It joins each point by a line
Linear regression It makes a linear regression with all the points
Parabolic regression It makes a parabolic regression with all the points
Spline It plots a curve that passes through each point

To calculate the concentration in a non-linear curve the inverse function of the

approximation curve is calculated.

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F=C_standard over {A_standard - A_blank}

 C5

ABS C4

Asample

C3

C2

C1

Ablank

Csample
CONC

Figure 120 Non-linear calibration curve

16.4. Repetition criteria

To activate automatic repetitions, the following programme options must be
programmed:
There is a general programme option for activating or deactivating all the auto-
matic repetitions:
1. Select the menu: Configuration/General/Work session
2. Activate the option: Automatic repetitions execution
For each test there is an individual option for activating or deactivating the auto-
matic repetitions.
1. Select the test you want to configure. Select the procedure tab.
2. Activate the edition mode and activate the option automatic repetition, con-
figure the dilution parameters.
3. In the options tab configure the parameter values for the repetitions.
Figure 113 shows the repetition criteria, depending on the programmed parameters.

Criterion Type of repetition

Concentration result < Detection limit Repetition with sample
concentration
Concentration result > Linearity limit Repetition with dilution
Minimum repetition range >Concentration result > Repeat in same way
Maximum repetition range
Concentration result < Minimum repetition range Do not repeat
Concentration result > Maximum repetition Do not repeat
Concentration result < Minimum panic range Repetition with sample
concentration

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Criterion Type of repetition

Concentration result > Maximum panic range Repetition with dilution
Minimum panic range >Concentration result > Do not repeat
Maximum panic range

 
  

 





       

 


 





 



formula23
 
  

 



   


    

Figure 121 Repetition criteria diagram

16.5. Calculation of the ISE ion concentration

The ISE module measures the lithium, sodium, potassium and chlorine in serum,
plasma and urine using ion-selective electrode technology. The continuous flow
sodium electrode uses a selective membrane, specially formulated to detect sodium
ions. The potassium, lithium and chlorine electrodes use a similar design with the
appropriate materials for the selective membranes. The potential for each electrode
is measured in relation to a fixed and a stable potential established by a reference
double-union silver/silver chloride electrode. The selective ion electrode develops
a voltage that varies depending on the concentration of the ion to which it re-
sponds. The ratio between the voltage developed and the detected concentration
is logarithmic as expressed by the Nernst equation.

RT
E x =E S  ⋅log  C  (12)
nF

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 formula22

formula14

Symbol Description
Ex Electrode potential in the sample solution
ES Potential developed in standard conditions
RT/nF Constant, depending on the temperature
a Ion coefficient of activity measured in the solution
C Ion concentration measured in the solution

A comparative method is used for measuring. First, the ISE module measures the
potentials developed by the sample when it is positioned in the electrodes. Then
calibrator A for serum samples or calibrator B for urine samples is positioned in the
electrodes. The difference between both measurements for each ion is proportional
to the quotient logarithm between the ion concentration in the sample and in
the calibration solution. The proportionality factor (S) is calculated in a previous
calibration operation described below. Since the differences in potential of the ion
concentrations in the calibrating solution are known, the concentration of the ions
in a sample solution can be calculated, using the Nernst equation, and rewriting:

formula15-ENG
E −E =S⋅log
x
C

S
  Cx
s
(13)

E x −E S

C x =C s · 10 S (14)

Symbol Description
Ex ISE voltage in the sample solution
ES ISE voltage in the calibrator solution
S Electrode slope calculated during the calibration process
Cx Ion concentration of the sample
CS Ion concentration of the calibrator solution

“S”, slope, is determined during the calibration using calibrators A and B, in which
the sodium, potassium and lithium levels are known.
When a two-point calibration is started, the slope is calculated based on the
difference between the reading of calibrator A and the reading of calibrator B.
Excessive shunt or noisy readings will be indicated and an error message will be
sent to the system.
The slope is defined as:

E B −E A
Slope=
E_x-E_S = S cdot log left(CC_x C_s right)
over (15)
log B
CA
C_x= C_s· 10^{{E_x-E_S}over S}

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Symbol Description
CA Concentration of calibrator A in mmol/L
CB Concentration of calibrator B in mmol/L
EA Voltage measured in the ISE of calibrator A in mV
EB Voltage measured in the ISE of calibrator B in mV

The calibration slope value is affected by the temperature and by the ageing of the
electrodes. It is verified that the slope value is within certain limits.

16.6. Internal Quality Control

Many commercial materials for internal control have assigned values. Several con-
centration values that correspond to different measuring methods are provided for
each component. In addition, each value is accompanied by an “admissible” value
(Manual mode). The usefulness of these values and intervals is debatable and it is
advisable not to use them for internal quality control.
Assigning values to control materials and establishing admissible value intervals
for internal quality control must be carried out in the laboratory itself (Statisti-
cal mode), in its own working conditions (instruments, reagents and operators).
Internal control must be designed so that it has very little sensitivity to tolerable
increases in error, while it must warn about significant errors.

16.6.1. Basis
The result obtained for a control material is compared with an admissible value
interval and a decision is taken:
• The result is within the interval: It is considered that the measuring procedure
maintains its accuracy within certain limits (it is stable) and the results of the
series are accepted.
• The result is outside the interval: It is considered that the measuring procedure
returns an error that is above tolerable levels and the results of the series are
rejected.

16.6.2. Admissible value interval

The best way to obtain the admissible value interval in the control material is
through a statistical estimate:
1. It is necessary to have sufficient quantity of a control material lot to meet the
requirements during a long period of time.
2. Perform at least 20 measurements, each one on a different series, using the
measuring procedure that must be controlled.
3. Calculate the mean value (Xm) and standard deviation (s) of the results ob-
tained. It is recommended to review these first estimates if more results are
available.

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 The dispersion of the results obtained is due to the imprecision of the measuring
procedure between series. This dispersion must have a normal distribution char-
acterised by the mean values and the standard deviation.
Therefore it is possible to establish a value interval with a known probability of
the result being included in that interval.
As it is required that the probability be high, it is common to select intervals be-
tween Xm ± 2s and Xm ± 3s. The selected criterion for establishing the admissible
value interval is a decision-based criterion or a control rule.
Internal control is based on the idea that it is not very likely that a result outside
the established limits will be obtained.
Control rules based on Gaussian statistics are usually represented by the expres-
sion Ans, where “A” is the number of control results and “ns” is the admissible
limit selected.
Different control results belonging to one control material or more than one may
also be used. Likewise the control results may have been obtained in one series or
in various consecutive series.
Rules that are more complex may be entered with various control results.
The ones most often used are the following:
22s Series rejected when 2 results are obtained that exceed 2s of the same type (posi-
tive or negative).
41s Series rejected if 4 results are obtained that exceed 1s of the same type.
10X Series rejected if 10 results are obtained on the same side of the mean.
R4s Series rejected if one result exceeds the +2s limit and the other exceeds the –2s
limit.
The rules for several control results may also give a clue as to the possible cause
of the increase in error. Rules 22s, 41s and 10X are particularly sensitive to systemic
error, whereas rule R4s is better at detecting increases in imprecisions.
Another interesting option is the combination of several rules in a logical or
algorithmic sequence. The best known combination is known as the Westgard
algorithm or rules for two control results.
In some cases it is not possible to make a statistical estimate of the dispersion of
results and apply control rules, because there are no accessible control materials
or because the measuring procedure is not used very often. In such situations it is
common to use a control material furnished by the supplier of the reagents or meas-
uring system, for which an admissible value interval is indicated (Manual mode).

16.6.3. Selection of control rules

The following objectives must be considered in selecting the rules to be used in
internal control:
• Simplicity: Use the least possible number of materials and control rules.
• Low probability of false rejections (≤ 2%, preferably < 1%).

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• High likelihood of detecting important increases in error. The lower the value
interval of the control rule, the greater probability there will be of detecting
increases in error.
The idea is to have the lowest possible number of false alarms and guide error-
detection to increases that are considered important, based on the understanding
that smaller errors may occur (tolerable errors) without being detected.

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17. Summary of workflow scenarios with
the LIS
This chapter describes the different scenarios defining interaction between the
BA200 and the information management software of a laboratory (LIS-Labora-
tory Information System). It describes the exchange of information between the
BA200 analyser and the LIS, such as for example in receiving work orders from
the laboratory for creating the worklist in the analyser and sending results from
the analyser to the LIS.
The BA200 implements two types of message or protocol message flows:
• The HL7 (Health Level 7) applied pursuant to the IHE (Integrating the
Healthcare Enterprise) recommendation
• The ASTM (American Society for Testing and Materials)
In this context the terminology used to describe data-transmission from the LIS
to the analyser is called Download and the data-transmission from the analyser
to the LIS is calledUpload.
The specimen is the content of each patient or control tube and may be one of the
types admitted (serum, urine, whole blood, etc). A patient may have two different
specimens, a serum one and a urine one. The tests indicated through a worklist
are performed on the specimen.
Transmission between the analyser and the LIS system is done through TCP/IP
connections.
• The TCP/IP for ASTM and HL7 is established when the system is initiated
and it must be permanently maintained provided the analyser is on. The
communication supports two setup modes: establishing the analyser as client
or as server.
• The HL7 also permits the transitory connection mode, which establishes two
connections at one time: When the BA200 starts a conversation a network
connection is established (a socket with an IP address and a port is opened) and
all the messages related to the conversation are sent and received by the socket.
When the LIS wants to initiate a conversation, another network connection
is initiated (another socket is opened with an IP address and a port) and all
the messages related to this conversation are sent and received through this
other socket.

17.1. Query by specimen and automatic start

A scenario in which the sample tubes to be analysed are positioned on the rotor,
the barcodes of each specimen are read and the LIS is asked for the work orders
for each specimen. The LIS sends the request for each specimen.
The chain of actions is as follows:
1. The user places the tubes of each specimen in the sample rotor.
2. The user presses the start button.

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3. The programme automatically performs the following actions:

• It reads the reagent rotor barcodes.
• It reads the sample rotor barcodes.
• It shows all the specimens read with the barcode on an auxiliary screen.
• It requests the LIS for the Query by specimen for each of the tubes.
• The LIS sends the work orders only for the requested specimens.
• It closes the auxiliary information screen.
• The work orders are downloaded, a worklist is generated and the automatic
execution of the worklist is started.
4. There are some exceptional cases in which the list does not start the execution
automatically.
• When the worklist contains calibrators or controls that must be positioned.
• When a reagent is missing in the worklist.
• When an ISE test has been requested for a urine sample. This sample
must be diluted and positioned manually on the rotor.
5. In exceptional cases, the programme does not start the execution and opens
the positioning screen for the user to correct the reasons for the exception.
In the event of communication problems or if the LIS system is very slow, it may
occur that the list is executed automatically but not all the work orders have been
received; in that case the add orders icon is activated. The user should press the icon
to add the pending orders to the worklist. If this situation occurs very often, the
user can change the configuration of the LIS response times and/or the number
of orders sent by message, to prevent this situation.
))See chapter 10.2.6 for the LIS operation configuration.
When the work session is being executed and the user presses the Query by
specimen button, the programme sends a request to the LIS for all the tubes read
with the barcode. This action serves to verify whether new tests have been added
to already-positioned tubes or if a request to repeat a test has been made.

17.2. Query All

Scenario in which the BA200 requests the LIS for work pending before the speci-
mens reach the analyser. In this case the LIS sends all the pending orders for that
analyser.
It is advisable for the LIS to filter orders and only send those corresponding to
the analyser making the request, otherwise pending orders will remain in the
analyser and the LIS will have to send cancellations when it receives results for
NOTE these from another analyser.
When the specimens reach the analyser, the barcodes are read or entered manually
and associated with the worklist. It may happen that there are fewer specimens
than the ones programmed in the worklist, so they will remain pending execution.
These pending requests are either executed through the arrival of the specimens
afterwards, or cancelled by the LIS.

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 The chain of actions is as follows:
1. Press the Query All button on the bar at the top. The analyser makes a generic
request for the worklist to the LIS.
2. The LIS sends all the work orders it has for the analyser. The programme
processes the orders and creates the worklist.
3. The user positions the sample specimens on the rotor and reads the barcodes.
4. The programme assigns to each specimen the information of the work order
programmed for the list.
5. The user can start the work session.
6. Once the list has been completed and the results obtained for each specimen,
the analyser sends them to the LIS. The sending of the results in real time is
done with the frequency configured by the user. (End of Test, End of Patient,
End of Work Session).
))See chapter 10.2.6 for the LIS operation configuration.
7. The LIS must send a cancellation of all orders not executed.

17.3. Sending results to the LIS. Upload.

After completing the worklist, the results are sent to the LIS. Depending on the
configuration established in the LIS setup screen, the results can be sent automati-
cally with the following frequency:
• At the end of each work session: the results are sent at the end of the work
session.
• After completing each patient: when the results of all the test on a patient
have obtained they are sent to the LIS.
• After completing each test: when a test has a result, it is sent to the LIS.
Results can also be sent to the LIS manually from the current results screen or
from the historical log screen.
When the transmission of control results requested from the analyser is active: all the
internal control results requested from the BA200 will be sent to the LIS. (With
the same sending frequency configured for sending results to the LIS: automatic
or manual).
When there is a LIS order related to a calculated test only the result of the calcu-
lated test is sent, and the results of partial tests are not sent, except when the LIS
expressly requests orders for partial tests and also calculated order tests.
The results of the external tests (off system)are also sent to the LIS. Observations
related to the results are sent to the LIS with a generic message.
On resetting the session, all the LIS orders that are pending or blocked are automati-
cally saved in a memorised LIS session. In this case the add orders button appears
active (indicating that there are LIS orders still to be processed in the analyser).
The name of the session is the following: LIS yyyyMMdd hh:mm:ss.

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These LIS orders that have not yet been processed in the analyser are automatically
added to the next work LIS session by pressing the button Add orders to LIS. After
adding them to a new session the memorised session is automatically eliminated.
To eliminate Pending LIS orders, the LIS must send the respective Cancellation
messages.
In the LIS utilities screen requests from the LIS that have not been processed can
be eliminated.

17.4. Repetitions
The parties who can request test repetitions are established in the LIS configuration
screen. The options are the following:
• LIS: Patient tests can only be repeated from the LIS. Requests for repeti-
tions are launched during the clinical validation from the LIS manager. The
manual option of patient sample repetitions in the current results screen will
be blocked. Blanks, calibrators and controls may be repeated via the analyser.
• Analyser: Patient tests can only be repeated from the analyser. Requests are
launched for repetitions during the technical validation of the results. Repeti-
tion orders received from the LIS will be rejected.
• Both: All the repetition requests coming from the LIS or from the analyser
are accepted.

17.5. Reasons for rejection

Below are possible reasons for rejecting messages through the B400.
Due to actions carried out by the user

Description Cause
The user deletes requests The required specimen has not been received
accepted from the LIS Lack of reagent
pending execution by the
Other reasons
BA200

Due to cancellations requested by the LIS

Description Cause
Lack of knowledge about the The cancelled test or sample type does not
type of patient sample or test exist in the BA200.
The test or sample type to be Execution of the test or sample type to be
cancelled has ended cancelled has already ended (the results have
already been obtained)

Due to a request for repetitions

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 Description Cause
Request from the LIS for a The repetition mode in the analyser has only
non-permitted repetition been selected in the BA200.
Request from LIS to repeat It is not permitted to request repetitions of
an internal QC control internal controls from the LIS.

Request from the LIS to It is not permitted to make requests for

repeat an incorrect test or repetitions of calculated tests or external tests.
sample type.
Repetition request from the The repetition request after receiving a result
LIS for a different specimen was for a different specimen identifier.
identifier.

Due to the incorrect field content

Description Cause
Unknown test or sample type The test and sample type identifier fields
are known by the BA200, but the test
was not programmed for the sample
type.
Internal control request for an An internal control was requested for a
erroneous test or sample type. calculated test or for an external test.
An internal control was requested for
a normal or ISE test and the quality
control parameters are not programmed
in the BA200.
Calculated test requires more than The calculated test is formed by tests
one sample type with different sample types.
Duplicate specimen The same specimen identifier was sent
for different patients
Duplicated request The same specimen identifier/test
identifier /sample type identifier was
already requested for the same patient
and their result has not yet been sent.

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18. Menu tree

To access the different programme options, this is structured based on menus. To
make it easy to browse in the system there are only two menu levels. The main
menu has the following options:

Main menu Description

Configuration This menu gives access to the different programme
configuration options.
Programming This menu gives access to the different programming
options permitted by the programme.
Work session This menu gives access to the creation of the current
session.
Current state This menu gives access to the current work session
status options.
Historical This menu show the historical log of results and
alarms.
Tools This menu gives access to the different programme
utilities.
Help This menu gives access to information about the
system.
Exit This menu allows the user to exit the application.

The submenu options are set out below:

Menu Submenu Description

Configuration General Selection of the different
general programme options
Language Language selection
Reports Patient report configuration
Report test order Configuration of test order for
the patient reports.
Barcode Configuration of the different
barcode options
LIS configuration Configuration of LIS
communication options
LIS mapping LIS test mapping configuration
Users Configuration of the different
users
Change user Option for changing the user

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Menu Submenu Description
Programming Tests Programming of test
parameters
Calculated Tests Programming of calculated test
parameters
Contaminations Contamination programming
Profiles Profile programming
Calibrators Programming of calibrators
Controls Programming of controls
Patient data Patient data entry
ISE Tests ISE test programming
External tests External test programming
Programming export Export the parameters of the
text to an external file
Programming import Import the parameters of the
test trom an external file

Menu Submenu Description

Work Session Sample Request Work session programming
screen
Rotor position Screen for positioning the work
session samples and reagents
Additional sample Screen for entering the patient
information data for the work session
Load session Option for loading a previously
memorised session
Save session Option for saving a session
Delete session Option for deleting a session
Delete rotors Option for deleting the rotor
positioning

Menu Submenu Description

Current status Monitor Menu for accessing current
information on the session.
Work session results Menu for viewing current
results.

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User manual

Menu Submenu Description

Historical Patient results Menu giving access to the
historical log of patient results
Blank and Calibrator Menu giving access to the
Results historical log of blanks and
calibrators
QC results Menu giving access to the
historical log of control results
Cumulative QC Menu giving access to the
results historical log of cumulative
control results
ISE Results Menu giving access to the
historical log of ISE calibration
results
Historical analyzer Menu giving access to the
alarms historical log of alarms

Menu Submenu Description

Tools Change Reaction Menu allowing the user to
Rotor change the rotor
Condition analyzer Menu giving access to the
option of conditioning the
analyser
ISE utilities This menu gives access to the
different ISE utilities
LIS utilities This menu gives access to the
different LIS utilities
Create SATReport Creation of a SATreport
Load SATreport Loading of a previously
generated SATreport
Create a restoration Backup copy option
point with current
data
Restore previous data Loading a previously generated
backup copy file
Audit trail Check the information of audit

Menu Submenu Description

Help User Manual Direct access to user manual
Analyser information Access to serial number
information
About Access to programme version

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Menu Submenu Description
Exit With Shutdown Option of exiting and switching
off the analyser
Without Shutdown Option of exiting the analyser
without switching it off

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