OM - CoaLAB 1000 Compact - GB V1.1

Operators Manual
CoaLAB 1000
For in-vitro diagnostic use only!

Liability Disclaimer
LABiTec LAbor BioMedical Technologies GmbH makes no express or implied warranty regarding this
manual, its quality, performance, or appropriate use regarding any type of specific procedure. Furthermore,
this manual may be modified by LABiTec LAbor BioMedical Technologies GmbH without notice and without
implying any obligation or liability on the part of the company.
Software Copyrights
All software for the CoaLAB 1000 (in the following Analyser-Software) is the user and instrument control
Software for the CoaLAB 1000 and is the intellectual property of the LABiTec LAbor BioMedical
Technologies GmbH. Intellectual property rights shall remain with LABiTec LAbor BioMedical Technologies
GmbH. You are entitled to use the Analyser-Software and the printed accompanying material at your place
of work only. Any violation of property rights or copyright or trademark or using conditions may be subject to
legal action. LABiTec reserves the rights to modify the software, hardware and documentation without any
prior written notice.
Intellectual Property
LABiTec LAbor BioMedical Technologies GmbH CoaLAB 1000 is registered trademark of LABiTec LAbor
BioMedical Technologies GmbH.
 2008 LABiTec LAbor BioMedical Technologies GmbH. All rights reserved.
No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or
translation into any language (human or computer) in any form, or by any means whatsoever, without the
prior written permission of LABiTec LAbor BioMedical Technologies GmbH.
Any reference to products, documentation, articles within this publication not expressly described as property
of LABiTec LAbor BioMedical Technologies GmbH shall be considered as intellectual property of the
publishing company of this certain product, documentation and or article.
Revision History
Analyser
Version Manual Date Software-Version -
(mm/dd/yy)
Release -
1.0 12/16/09 -- Initial version
1.1 04/16/10 V01.01 SW-Update
LABiTec GmbH
An der Strusbek 6
D-22926 Ahrensburg
Germany
Warranty
LABiTec LAbor BioMedical Technologies GmbH warrants to the original purchaser for a period of one (1)
year after the date of supply against defects in material and workmanship and defects arising out from failure
to conform to specification applicable on the date of supply, provided they are properly installed, used and
with accessories and consumables in accordance with these operating instructions.
LABiTec LAbor BioMedical Technologies GmbH further agrees to correct, either by repair, or, at its election,
by replacement, any such defect found on examination to have occurred, under normal use and service,
during such one-year period, provided LABiTec LAbor BioMedical Technologies GmbH is properly notified in
writing upon discovery of such defect.
LABiTec LAbor BioMedical Technologies GmbH shall not be liable under this warranty for any defect arising
from abuse of the system, failure to operate and maintain the system in accordance with the documentation
included with the instrument, including repair service, alternation or modification of the system by any person
other than authorized personnel, or use of modified, changed, or previously used disposables, defects
caused by transportation/shipping and accidents, storms, lightening, fire, water/other liquids, other natural
catastrophes, theft, riots, plundering, the effects of war or other instances of acts of god.
The warranty of LABiTec LAbor BioMedical Technologies GmbH set forth above and the obligations and
liabilities of LABiTec LAbor BioMedical Technologies GmbH there under are exclusive and in lieu of all other
remedies or warranties, express or implied, arising by law or otherwise, with respect to the system delivered
hereunder (including without limitation any obligation of LABiTec LAbor BioMedical Technologies GmbH with
respect to merchantability, fitness for particular purpose and non-infringement). In no event shall LABiTec
LAbor BioMedical Technologies GmbH be liable for incidental or consequential damages, however, arising
and whatever or not occasioned by LABiTec LAbor BioMedical Technologies GmbH negligence.
This warranty shall not be extended or altered except by written instrument signed by LABiTec LAbor
BioMedical Technologies GmbH.
Exclusions of manufacturers warranty:
• The use of none permitted peripheral devices, e.g. printer.

• Improper use/operating faults and non-adherence to the user instructions.
• Attempted repairs by the customer or third-parties without authorization by manufacturer.

• Defective maintenance by third parties without authorization by manufacturer.
• Device defects due to power failure, heat losses or similar reasons.
• Accidents, storms, lightening, fire, water/other liquids, other natural catastrophes, theft, riots, plundering,
the effects of war or other instances of acts of god.
• Defects caused by transportation/shipping.
• The use of third party components, unauthorized consumables or accessories which do not comply to
manufacturers specifications.
• Non-authorised system changes.
• Resetting safety functions, deletion of passwords etc.
• Loss of customer data or software from repair and installation processes.
• Improper use of machine capacity or output.
• Inappropriate customer operating environment.
• Products from which the category plates, serial numbers, part numbers on the machine or machine parts
have been removed or changed.
• Wear and tear appearances at components like for example LCD.
• Breaks and scratches, dirtying on e.g. LCD displays or dirtying of the measuring channels.
Certifications
Specifications for Safety
This instrument conforms to the appropriate European Directives.
IVD The instrument type described in this manual bears an IVD and CE mark,
which confirms the compliance with essential requirements of the following:
European Directive: 98/79/EC In-vitro Diagnostic directive.
For further information see chapter 7.5 Safety Specifications

Contents
TABLE OF CONTENTS
LIST OF FIGURES --------------------------------------------------------------------------------- 3
1 INTRODUCTION ------------------------------------------------------------------------------- 6
1.1 Application ------------------------------------------------------------------------------------------- 6
1.2 Purpose of this instruction manual ------------------------------------------------------------- 6
1.3 Validity of this instruction manual -------------------------------------------------------------- 6
2 HAZARD AND PRECAUTIONS ----------------------------------------------------------- 7
2.1 Hazard Warnings and Safety Notices --------------------------------------------------------- 7
2.2 Standard Symbols ------------------------------------------------------------------------------- 10
3 SYSTEM DESCRIPTION ------------------------------------------------------------------ 11
3.1 Analyser description ----------------------------------------------------------------------------- 11
3.1.1 Touchscreen------------------------------------------------------------------------------- 12
3.1.2 Working Plate ----------------------------------------------------------------------------- 14
3.1.3 Cuvette Ring Position ------------------------------------------------------------------- 15
3.1.4 Sample Area------------------------------------------------------------------------------- 16
3.1.5 Dilutor ---------------------------------------------------------------------------------- 17
3.1.6 Pipettor ---------------------------------------------------------------------------------- 18
3.1.7 Rinsing System --------------------------------------------------------------------------- 18
3.1.8 Peripheral equipment and mains connection-------------------------------------- 20
3.2 Software -------------------------------------------------------------------------------------------- 22
3.2.1 Software control via touch screen---------------------------------------------------- 23
3.2.2 Software Overview----------------------------------------------------------------------- 28
3.2.3 Program Menus--------------------------------------------------------------------------- 29
3.2.3.1 Main Menu ------------------------------------------------------------------------- 29
3.2.3.2 Setup Menu------------------------------------------------------------------------ 35
3.3 Measuring Principle------------------------------------------------------------------------------ 36
3.4 Reagents ------------------------------------------------------------------------------------------- 37
3.5 Load Cuvette Rings to analyzer (depending on model)--------------------------------- 38
4 INSTALLATION ------------------------------------------------------------------------------ 42
4.1 General Setup------------------------------------------------------------------------------------- 42
4.2 Removing the Transport Protections -------------------------------------------------------- 44
4.3 Assembly of the analyser----------------------------------------------------------------------- 44
4.3.1 Mount the diluter syringe --------------------------------------------------------------- 44
4.3.2 Connecting the Rinsing System ------------------------------------------------------ 45
4.3.3 Connecting an UBS Memory Device ------------------------------------------------ 46
4.3.4 Connecting an external printer -------------------------------------------------------- 47
4.3.5 Connecting a Barcode Scanner (option) ------------------------------------------- 48
4.3.6 Connecting a Personal Computer (for Service only) ---------------------------- 48
5 OPERATION ---------------------------------------------------------------------------------- 49
5.1 System Start-up ---------------------------------------------------------------------------------- 49
5.1.1 Switch On ---------------------------------------------------------------------------------- 49
5.1.2 System Liquids---------------------------------------------------------------------------- 52
5.1.3 Fill liquid system and flush system--------------------------------------------------- 53
5.2 Routine Menu ------------------------------------------------------------------------------------- 54
5.2.1 Load/Replace Cuvettes ----------------------------------------------------------------- 54
5.2.2 Load Reagents---------------------------------------------------------------------------- 56
5.2.3 Load Samples (Routine & STAT) ---------------------------------------------------- 64
5.2.4 Start Measurements (Routine & STAT)--------------------------------------------- 72
5.2.5 Show/print results ------------------------------------------------------------------------ 79
5.2.6 Results Memory -------------------------------------------------------------------------- 80
5.2.6.1 Show/print reaction curves----------------------------------------------------- 81
CoaLAB 1000 – Operators Manual 1.1 Page 1

Contents
5.2.7 Analyser Status --------------------------------------------------------------------------- 84

5.3 Setup Menu---------------------------------------------------------------------------------------- 85
5.3.1 Im/Export test & reagent parameter via USB-Stick ------------------------------ 86
5.3.1.1 Mounting an USB-Stick --------------------------------------------------------- 86
5.3.1.2 Import data from USB-Stick---------------------------------------------------- 86
5.3.1.3 Export data to USB-Stick ------------------------------------------------------- 89
5.3.2 Select Working Modes ------------------------------------------------------------------ 91
5.3.3 Setup Reagent definition --------------------------------------------------------------- 92
5.3.3.1 Parameter Page 1---------------------------------------------------------------- 93
5.3.3.2 Parameter Page 2---------------------------------------------------------------- 96
5.3.4 Setup Test Definition -------------------------------------------------------------------100
5.3.4.1 Liquids -----------------------------------------------------------------------------102
5.3.4.2 Evaluation -------------------------------------------------------------------------104
5.3.4.3 Determination --------------------------------------------------------------------110
5.3.4.4 Define Results/Run list---------------------------------------------------------113
5.3.5 Calibration---------------------------------------------------------------------------------115
5.3.5.1 Edit Calibration for Clotting (manual calibration) ------------------------117
5.3.5.2 Edit Calibration for Kinetic / Diff. / 1st devi (manual calibration) ------124
5.3.5.3 Auto Calibration for Clotting (automated calibration) -------------------130
5.3.6 Delete Results ---------------------------------------------------------------------------147
5.3.7 Setup Language -------------------------------------------------------------------------148
5.3.8 Setup Date & Time----------------------------------------------------------------------149
5.3.9 Change Password ----------------------------------------------------------------------150
5.3.10 Setup Beeper-----------------------------------------------------------------------------151
5.3.11 Setup STAT Autoprint------------------------------------------------------------------152
5.3.12 Define Headline--------------------------------------------------------------------------152
5.3.13 Initiate Analyser Selftest ---------------------------------------------------------------153
5.4 Switch off analyser ------------------------------------------------------------------------------155
6 SAFETY IN OPERATION-----------------------------------------------------------------156
6.1 Maintenance and Hygiene --------------------------------------------------------------------156
6.1.1 Maintenance frequency----------------------------------------------------------------157
6.1.2 Cleaning of the housing----------------------------------------------------------------157
6.1.3 Clean Pipettor ----------------------------------------------------------------------------158
6.1.4 Clean Containers/Sensors Replace Filter -----------------------------------------159
6.1.5 Perform cleaning cycle-----------------------------------------------------------------159
6.1.6 Perform washing cycle -----------------------------------------------------------------161
6.1.7 Protocol of Maintenance Check -----------------------------------------------------162
6.1.8 How to dispose of used disposables -----------------------------------------------162
6.1.9 Disposal of the Analyser---------------------------------------------------------------162
6.2 Troubleshooting ---------------------------------------------------------------------------------163
6.2.1 Application errors------------------------------------------------------------------------163
6.2.2 Error Flags in the Results/Run or Results/Memory List------------------------164
6.2.3 Errors during operation ----------------------------------------------------------------164
6.2.4 How to change fuses -------------------------------------------------------------------168
7 APPENDIX------------------------------------------------------------------------------------169
7.1 Materials supplied -------------------------------------------------------------------------------169
7.2 Disposables/Consumables--------------------------------------------------------------------169
7.3 Maintenance Kit ---------------------------------------------------------------------------------170
7.4 Technical Data -----------------------------------------------------------------------------------171
7.5 Safety Specifications ---------------------------------------------------------------------------173
7.6 Mathematics --------------------------------------------------------------------------------------174

List of Figures
LIST OF FIGURES
Figure 1 CoaLAB 1000 system ................................................................................................................ 11
Figure 2 Touch Screen............................................................................................................................. 12
Figure 3 Reagent Area............................................................................................................................. 14
Figure 4 Measuring Rotor ........................................................................................................................ 15
Figure 5 Cuvette Ring .............................................................................................................................. 15
Figure 6 Sample Area............................................................................................................................... 16
Figure 7 Dilutor Module............................................................................................................................ 17
Figure 8 Pipettor....................................................................................................................................... 18
Figure 9 Container and level sensors for distilled water (green) and waste water (red).............................. 18
Figure 10 Rinsing System .......................................................................................................................... 19
Figure 11 External interfaces (rear view) ................................................................................................... 21
Figure 12 Main Menu functions.................................................................................................................. 23
Figure 13 Area frame, scroll buttons, select window.................................................................................. 24
Figure 14 Select box, Check Box............................................................................................................... 25
Figure 15 Movable Window........................................................................................................................ 26
Figure 16 Movable Window (Graph) .......................................................................................................... 27
Figure 17 Message Box ............................................................................................................................. 27
Figure 18 MAIN MENU .............................................................................................................................. 29
Figure 19 Run Preparation......................................................................................................................... 30
Figure 20 Required Reagents .................................................................................................................... 31
Figure 21 Short form Results ..................................................................................................................... 32
Figure 22 Result Selection ......................................................................................................................... 33
Figure 23 Result/Memory........................................................................................................................... 33
Figure 24 Status Menu............................................................................................................................... 34
Figure 25 Setup Menu ............................................................................................................................... 35
Figure 26 Measuring Principle ................................................................................................................... 36
Figure 27 CuvCARD/ChipCARD Reader ................................................................................................... 39
Figure 28 Message: Load CuvCARD ......................................................................................................... 39
Figure 29 Message: Overwrite loaded balance.......................................................................................... 40
Figure 30 Message: No C-Rings loaded .................................................................................................... 40
Figure 31 Message: Overview of loaded C-Rings...................................................................................... 41
Figure 32 Carry handles............................................................................................................................. 42
Figure 33 Mount of Dilutor Syringe ............................................................................................................ 44
Figure 34 Connect the level sensor tubes to the analyser ......................................................................... 45
Figure 35 Container for distilled water. Container and tubes are coded with green. .................................. 46
Figure 36 Container for waste water. Container and tubes are coded with red.......................................... 46
Figure 37 USB-Stick Interface.................................................................................................................... 46
Figure 38 Status Line with active print ....................................................................................................... 47
Figure 39 Message: Shield Control............................................................................................................ 49
Figure 40 Message: Insert Cuvette Ring.................................................................................................... 50
Figure 41 Analyser Status Message .......................................................................................................... 50
Figure 42 Pump Test ................................................................................................................................. 51
Figure 43 Pump Test failed ........................................................................................................................ 51
Figure 44 Pump Test OK ........................................................................................................................... 52
Figure 45 MAIN MENU .............................................................................................................................. 52
Figure 46 Run Preparation Menu............................................................................................................... 53
Figure 47 Load C-Ring............................................................................................................................... 54
Figure 48 Remaining C-Ring balance ........................................................................................................ 55
Figure 49 Load Reagents........................................................................................................................... 56
Figure 50 Test Select List .......................................................................................................................... 56
Figure 51 Reagent/Washer Table .............................................................................................................. 57
Figure 52 Vials Menu ................................................................................................................................. 58
Figure 53 Vials Menu Example: PT............................................................................................................ 58
Figure 54 Message: Renew Reagent......................................................................................................... 59
Figure 55 Change reagent position............................................................................................................ 59
Figure 56 Target Position........................................................................................................................... 60
Figure 57 Change vial size......................................................................................................................... 60
Figure 58 Tools in Vials Menu.................................................................................................................... 61
Figure 59 Load Reagents........................................................................................................................... 62
Figure 60 Tools in Load Reagents ............................................................................................................. 63
Figure 61 Load Samples ............................................................................................................................ 64
Figure 62 Edit Sample ID ........................................................................................................................... 64
Figure 63 Entered Sample ID..................................................................................................................... 65
Figure 64 Sample/STAT Positions ............................................................................................................. 66
Figure 65 Sample Rack 1..11..................................................................................................................... 66
Figure 66 Sample Rack 12..22................................................................................................................... 67

List of Figures
Figure 67 STAT Rack 1..3.......................................................................................................................... 67

Figure 68 Vial Frame ................................................................................................................................. 68
Figure 69 Sample with assigned vials ........................................................................................................ 69
Figure 70 Select test/assay........................................................................................................................ 69
Figure 71 Clone Mode ............................................................................................................................... 70
Figure 72 Tools in Load Samples .............................................................................................................. 70
Figure 73 Run Preparation Menu............................................................................................................... 71
Figure 74 Menu Measurement ................................................................................................................... 72
Figure 75 Tools in Measurement Menu ..................................................................................................... 73
Figure 76 Close Shield Message ............................................................................................................... 73
Figure 77 Running Measurement............................................................................................................... 74
Figure 78 Prepare STAT run...................................................................................................................... 74
Figure 79 Load STAT Samples.................................................................................................................. 75
Figure 80 Warning Message before STAT................................................................................................. 75
Figure 81 Load STAT Samples.................................................................................................................. 75
Figure 82 Status Window ........................................................................................................................... 76
Figure 83 Immediate STOP ....................................................................................................................... 76
Figure 84 Warning user interrupt ............................................................................................................... 77
Figure 85 Pending Measurements ............................................................................................................. 77
Figure 86 Short Form Results .................................................................................................................... 77
Figure 87 Tools in Running Measurement Screen..................................................................................... 78
Figure 88 Results/Run ............................................................................................................................... 79
Figure 89 Results/Memory 1 ...................................................................................................................... 80
Figure 90 Results/Memory 2 ...................................................................................................................... 81
Figure 91 Curve Input ................................................................................................................................ 81
Figure 92 Curve Input keyboard................................................................................................................. 81
Figure 93 Tools in Results/Memory ........................................................................................................... 82
Figure 94 Reaction Curves ........................................................................................................................ 82
Figure 95 Tools in Reaction Curve Diagram .............................................................................................. 83
Figure 96 Status Menu............................................................................................................................... 84
Figure 97 Setup Menu ............................................................................................................................... 85
Figure 98 Stop System............................................................................................................................... 86
Figure 99 Im/Export Test & Reagent Parameters ...................................................................................... 87
Figure 100 Import Test & Reagent Parameters ........................................................................................... 87
Figure 101 Importing Parameters ................................................................................................................ 88
Figure 102 Parameter Import OK................................................................................................................. 88
Figure 103 Im/Export Test & Reagent Parameters ...................................................................................... 89
Figure 104 Export Test & Reagent Parameters ........................................................................................... 90
Figure 105 Remove USB-Stick .................................................................................................................... 90
Figure 106 Mounting another USB-Stick...................................................................................................... 90
Figure 107 Setup Working Modes................................................................................................................ 91
Figure 108 Select Reagent Screen .............................................................................................................. 92
Figure 109 Edit Reagent Main Screen ......................................................................................................... 93
Figure 110 Edit Reagent Page 1.................................................................................................................. 93
Figure 111 Tools in Edit Reagent Page 1 .................................................................................................... 95
Figure 112 Edit Reagent Main Screen ......................................................................................................... 95
Figure 113 Edit Reagent Page 2.................................................................................................................. 96
Figure 114 Tools in Edit Reagent Page 2 .................................................................................................... 98
Figure 115 Tools in Edit Reagents Main Screen.......................................................................................... 99
Figure 116 Select Test Screen................................................................................................................... 100
Figure 117 Test Menu Main Page.............................................................................................................. 101
Figure 118 Test Menu Liquids.................................................................................................................... 102
Figure 119 Tools in Test Menu Liquids ...................................................................................................... 103
Figure 120 Test Menu Evaluation .............................................................................................................. 104
Figure 121 Test Menu Tech Clotting.......................................................................................................... 105
Figure 122 Test Menu Evaluation/Kinetic .................................................................................................. 107
Figure 123 Test Menu Tech Kinetic ........................................................................................................... 108
Figure 124 Test Menu Evaluation/Kinetic .................................................................................................. 109
Figure 125 Test Menu Main Page.............................................................................................................. 110
Figure 126 Test Menu Determin. ............................................................................................................... 110
Figure 127 Test Menu Misc. Smoothing .................................................................................................... 112
Figure 128 Test Menu Show-Flags ............................................................................................................ 113
Figure 129 Tools in Test Menu Main Page ................................................................................................ 114
Figure 130 Setup Menu ............................................................................................................................. 115
Figure 131 Select test Calibration .............................................................................................................. 116
Figure 132 Calibration Menu Main Page.................................................................................................... 116
Figure 133 Calibration Menu Clotting......................................................................................................... 117
st
Figure 135 Calibration Values 1 evaluation.............................................................................................. 120

List of Figures
Figure 136 Calibration Curve Graph .......................................................................................................... 122

Figure 137 Tools in Calibration Graph Screen ........................................................................................... 123
Figure 139 Calibration Menu Kin/Diff/1st devi ............................................................................................. 124
Figure 141 Calibration Values 2nd evaluation ............................................................................................. 127
Figure 142 Tools in Calibration Value Screen............................................................................................ 128
Figure 144 Select test Calibration .............................................................................................................. 130
Figure 146 Calibration Menu Clotting......................................................................................................... 132
Figure 148 Calibration Values (concentration) ........................................................................................... 134
Figure 150 Control & Calibrator Positions C1-C8....................................................................................... 137
Figure 151 Place Calibrator Position 1....................................................................................................... 138
Figure 152 Reagent Status List Calibration................................................................................................ 138
Figure 153 Tools in Calibration Measurement Menu ................................................................................. 139
Figure 154 Close Shield Message ............................................................................................................. 140
Figure 155 Running Measurement Calibration........................................................................................... 140
Figure 156 Tools in Calibration Measurement Menu ................................................................................. 141
Figure 157 Reaction Curves Calibration .................................................................................................... 141
Figure 158 Running Measurement Calibration........................................................................................... 142
Figure 159 Results/Run List Calibration..................................................................................................... 142
Figure 160 Warning Message Calibration .................................................................................................. 143
Figure 161 Warning Message Measuring Status ....................................................................................... 143
Figure 162 Auto Calibration finished .......................................................................................................... 144
Figure 164 Calibration data........................................................................................................................ 144
Figure 165 Calibration Curve ..................................................................................................................... 145
Figure 166 Tools in Calibration Graph Screen ........................................................................................... 145
Figure 167 Delete Results.......................................................................................................................... 147
Figure 168 Delete Results Message Box ................................................................................................... 147
Figure 169 Setup Language....................................................................................................................... 148
Figure 170 Select Language ...................................................................................................................... 148
Figure 171 Setup Date & Time................................................................................................................... 149
Figure 172 Date & Time Settings ............................................................................................................... 149
Figure 173 Change Password.................................................................................................................... 150
Figure 174 Setup Password....................................................................................................................... 150
Figure 175 Setup Beeper ........................................................................................................................... 151
Figure 176 Setup STAT autoprint .............................................................................................................. 152
Figure 177 Define Headline ...................................................................................................................... 152
Figure 178 Selftest..................................................................................................................................... 153
Figure 179 Selftest Transmission............................................................................................................... 153
Figure 180 Selftest finished........................................................................................................................ 154
Figure 182 Shutdown Analyzer .................................................................................................................. 155
Figure 183 Shutdown Selection ................................................................................................................. 155
Figure 184 Perform Cleaning Cycle ........................................................................................................... 160
Figure 185 Perform Washing Cycle ........................................................................................................... 161
Figure 186 Change fuses, voltage selector................................................................................................ 168

Introduction
1 INTRODUCTION
This chapter provides a global introduction to the CoaLAB 1000 system. It is
recommended to read this chapter first.
NOTE
Read this manual carefully before you attempt to operate the CoaLAB
1000 system.
1.1 Application
The CoaLAB 1000 named hereafter as analyser, is a fully automated photo-

optical blood plasma hemostasis instrument capable of performing clotting,
chromogenic* and immunoassays* simultaneously in random access or
batch mode from primary and secondary tubes.
For in-vitro diagnostic use only!
* Depending on the analyser model the system is capable to perform a wide

range of coagulometric, chromogenic and immunologic coagulation tests
such as Prothrombin time, activated and partial Thromboplastin time,
Fibrinogen, derived Fibrinogen and special tests such as single factor
assays, Anti-Thrombin III, Protein C, Protein S, C-Reactive Protein, D-
Dimer and others based on the wavelength available in different analyser
types.
However; the manual will indicate any difference between the available
model types if required.
The analyser is intended for use by trained operators in coagulation labs for
in-vitro diagnostics.
1.2 Purpose of this instruction manual
The instruction manual describes the analyser and is directed to all users of
the system.
This instruction manual gives all information necessary for the installation,
operation, maintenance, storing, packing, and transport of the analyser.
Service information is handled separately.
Careful observation of all information, especially of hazards and precautions

will ensure the correct and safe operation of the analyzer. Therefore it is
absolutely necessary to read the instruction manual completely.
This instruction manual was prepared with greatest care. Should you have
any questions please refer to your distributor or to the manufacturer.
1.3 Validity of this instruction manual
All information in this instruction manual refers to this analyser.

For all requests please indicate type and serial number of your system
which can be found on the type plate on the back of the instrument.

Hazard and Precautions
2 HAZARD AND PRECAUTIONS

This chapter contains important hazard and precaution information.
NOTE Read chapter before you attempt to operate the analyser.
2.1 Hazard Warnings and Safety Notices
The cautions and safety regulations in this instruction manual meet

international classifications, refer to chapter 2.2 Standard Symbols.
This manual uses different types of symbols to alert you to important

information. Symbols and their associated information are labelled in text
where they occur and set off from surrounding paragraphs as shown in the
following examples.
Symbol warns of a risk of injury or of a risk to life (for example by electrical

shock).
Danger!
Symbol warns of a risk of injury or of the instrument being severely

damaged.
Caution!
NOTE Symbol introduces rules to be observed.
The following caution and safety regulations must be observed at all times:
1. Electrical safety
Check that the operating voltage is set correctly before you connect the
device to the main power supply.
To connect the device to the power supply, use only sockets which are
Danger!
grounded in order to keep the risk of an electrical shock as low as possible.
Use only grounded extension cables.
Never remove protective guards or secured components since you

could expose electrically live parts in this way.
Electrical connection contacts (plugs, sockets, etc.) can be electrically live.
Even after a device has been switched off, components (e.g.

capacitates) can be under voltage as the result of an electrical charge.
All current carrying parts are sources of danger for an electrical shock.
Never use the instrument on a moist surfaces (floor, worktable or
countertop), or place containers of liquids on top of the instrument. Liquids
spilled into the instrument may cause an electrical shock.
Carry out only the maintenance work and/or the replacement of parts
described in these operating instructions. Switch off the instrument
and disconnect it from all power sources before performing
maintenance or repair work.

Unauthorized work on the analyser can lead to the guarantee obligation

becoming null and void with necessary expensive service work to correct it.
All work which requires the analyzer to be opened may only be carried
out by a technician who is familiar with the risks related thereto.
Use only replacement fuses of the stated type and with the stated nominal
current.
- Never use fuses which have been "repaired".
- Never short-circuit the fuse holder.
2. Fire and explosion
hazards
Do not place any flammable or hazardous explosive material in the
proximity of the analyzer.
Caution!
3. Mechanical safety
(Analyzer is operating)
Never open screw-attached housing part! There is a risk of injury.
Avoid touching the pipettor and other moving parts during analyser
Caution! operation. Moving parts (fan, motor drives, pipettor) can cause injuries.
Do not open any covers before a measuring series has been terminated or
interrupted. Opening covers can damage the pipettor.
Ensure the pipettor does not stop over the sample positions or the
measuring rotor when the instrument is switched off.
- Use the protection cap for the pipettor if the system will not be operated
for a long time, to avoid damage and contamination.
Put the instrument out of operation and secure it against inadvertent use if
you come to the conclusion that it can no longer be operated safely.
This is to be assumed in the following cases:

- the instrument shows visible damage,
- the instrument no longer functions,
- the instrument has been stored or transported for a prolonged period
under unfavourable conditions.
4. Samples/Reagents Risk of infections

Avoid any contact between samples and/or test reagents with skin or
mucous membranes and any contact with parts of the instrument that come
into contact with samples/reagents. All consumables, e.g. cuvettes,
Caution! reagent vessels, pipette tips that may be used to transfer liquid
samples and reagents should be considered to be potentially infectious. If
specimens are spilled on the system, wipe them off at once and disinfect
the instrument (see Chapter 6.1). Reagents may cause irritation to the skin
and mucous membranes.
Always follow the manufacturer’s instructions for correct use given in

the literature accompanying the reagent.
Dispose of spent samples and waste reagents and all consumables that
have come into contact with them after completion of the measurements
strictly in accordance with statutory directives and laboratory guidelines.
NOTE Wear safety gloves! There is the risk of infection.

The correct Washing Solution must be used to avoid carry-over after using
thrombin containing reagents.
The analysers Washing Solution has an open vial stability of 7 days at 20°C
Caution!
to 30°C.
For cleaning the system waste tubing and pipettor the correct analyser
Cleaner must be used to avoid contamination and grow of alga.
Keep the Cleaner bottle closed if not used. Keep away from cold, heat and
sunlight. Store Cleaner at room temperature.
5. Waste Liquids
The waste liquid in the waste container must be disposed in compliance

with applicable regulations.
Caution!
The liquid waste of the analyser is potentially infectious. To reduce the
possibility of exposure, use of personal safety gear (eye goggles, gloves,
etc.) is necessary. Any liquid waste material is to be emptied into approved
biohazard containers.
The liquid system tubing’s are not guaranteed to be resistant against

organic solvents. For this reason, use the analyser Cleaner only.
6. Accuracy and precision

of the measured results
In order to ensure a flawless operation of the analyser measure control
samples and/or standards and watch the function of the instrument closely.
Vorsicht!
Caution! False results may lead to an incorrect diagnosis and, therefore, risk for the
patient.
7. Cuvette Ring handling

If a new cuvette ring is loaded the analyser performs an automatic cuvette
recognition check.
Caution! Always place a new cuvette ring matching the marking on the cuvette ring
rotor and cuvette ring, see chapter 3.1.3 Cuvette Ring Position.
The software can distinguish between an empty and a full (used) cuvette
ring. However, there may be circumstances to those the liquid may not be
recognised, for example water (clear liquids, dried residues). Therefore
when loading a new cuvette ring ensure an empty cuvette rings is always
being used.
If a new cuvette ring is replaced against a used cuvette ring after the
cuvette recognition has been performed, the following pipetting may lead to
cuvette overflow.
8. Restrictions for samples

and reagents
Resistance of cuvettes to organic solvents cannot be guaranteed. For this
reason, organic solvents should not be used unless they have been
expressly permitted. Only use the original manufacturer’s cuvettes and
Caution! mixers! Use cuvettes and mixers only once! Prior of each measurement
ensure a mixer is added to each cuvette.
9. User qualification
The analyser should only be operated by trained personnel. Ask you local
dealer or distributor for further information on the availability of user
trainings.
Caution!

10. Barcode Scanner

Be careful when using the barcode scanner laser light.
- Avoid direct eye contact with the laser beam.

- Follow the manufacturer’s instructions.
Danger! - Ensure the scanner was tested and authorized for use by the
manufacturer.
CAUTION
LASER LIGHT
DO NOT STARE INTO BEAM
670nm LASER DIODE

1.0 MILLIWATT MAX
CLASS II LASER PRODUCT
VORSICHT
LASERSTRAHLUNG, NICHT IN DEN LICHTSTRAHL BLICKEN,
SICHTBARE LASERSTRAHLUNG, LASERKLASSE 2
2.2 Standard Symbols
A large number of symbols are used in this Operator’s Manual, on the

instrument itself, and on available accessories and consumables. Their
meanings are given below:
Manufacturer Order Number
In Vitro Diagnostic Medical Device Serial Number
CE Conformity Batch Code
Refer to Operators Manual Do Not Reuse
Protect From Sunlight Caution
Temperature Limitation Danger
Humidity Limitation NOTE Important Information
Recyclable Corrosive
Electric Shock Warning Biological Risk
Fuse This side up
Separate collection, handling and

Switch off Analyser and disconnect
disposal for waste electrical and
all power sources before performing
electronic equipment and its
maintenance or repair work.
components

System Description
3 SYSTEM DESCRIPTION
This chapter contains detailed analyser description, its components and
provides detailed information on how to unpack and install the analyser the
first time.
3.1 Analyser description
The analyser represents a new the state of the art development and is a
microprocessor-controlled, two-channel photo-optical fully automated blood
plasma hemostasis analyser. The analyser is a modular construction.
Figure 1 CoaLAB 1000 system
1- Pipettor
2- Cup Array for Sample Cups (Controls/Calibrators)
3- Reagent Block (removable)
4- Washer / Cleaner Position
5- Rinsing Station
6- Measuring / Cuvette Ring Rotor
7- STAT Positions
8- Sample Positions
9- USB Stick Interface (underneath) + handles to carry analyzer
10 - Touch sensitive colour display
11 - Safety Shield
Handling of safety shield:

It is recommended to always close the safety shield during analyser
Caution! operation to avoid injuries and damage of moving parts.

System Description
Open the safety shield only when the message “Shield may be opened now”
appears on the display.
NOTE The safety shield must be opened all the way to the top.
Close the safety shield when the message “Please close the shield now!”
appears on the display. Softly move the shield down into the closed position.
3.1.1 Touchscreen
The touch screen control panel offers several functions. On one hand, it is
designed for the visual display of the entire instrument control software. On
the other hand, it is used for inputting information, acknowledgment of
software messages, display of application and test ranges and for
communication with the user.
The LCD colour touch screen offers a visible area of 11.5 x 8.7cm and
provides a display resolution of 320 x 240 pixels, ¼ VGA).
Its touch sensitivity makes it possible to navigate your way round the
software simply by pressing the surface of the user control panel. Use either
your finger tip or a blunt object, e.g. a touch screen pen designed for this
purpose.
Never use a sharp object (finger nail, knife, letter opener) to press on
NOTE the control panel as it might cause irreparable damage to the control
panel surface.
Figure 2 Touch Screen

System Description
Function and Navigation Keys
The touch screen display of the analyser offer certain
Scroll-up by one window/page
Scroll-up by one line
Scroll-down by one window/page
Scroll down by one line
ESC key to cancel and leave a display/action
OK key to select an action
Undo& Exit key to leave a display without confirming

and saving input
Save & Exit to leave a display and save input
Tools key to enter into a selection menu offering

further actions
Keyboard (alphanumeric / numeric)

Alphanumeric keys, some with special symbols,
for text and numerical information input
Activates upper or lower case
Activates numeric keys and special symbols
Space bar, or overwriting input
Numeric keys, for numerical information input
Exponent key
Short dash key, e.g. to separate two numbers
Decimal or comma key
Arrow keys to move the cursor around the input

field
For deleting the input to the left of the cursor
Confirm and save input
Leave input field (keyboard window) without

confirming and saving input

System Description
3.1.2 Working Plate

The analyser is equipped with a working plate which offers all positions to
load routine & STAT samples, reagents, controls & calibrator, washer,
cleaner and cuvette rings. This Working Plate is actually divided into three
single areas:
1- Reagent Area, consists of :

Washer & Cleaner Positions,
Reagent Block (removable),
Control & Calibrator Positions
2- Cuvette Ring Position, consists of :

Cuvette Ring / Measuring Rotor,
Wash / Rinsing Position
3- Sample Area, consists of :

Routine Sample Cup Positions,
STAT Positions
Reagent Area
The Reagent Area is a combination of different liquid positions at room
temperature. The Reagent Area offers positions for Washer and Cleaner,
reagent positions, diluents as well as positions for controls & calibrators.
Figure 3 Reagent Area
W1-W2 2x Washer & Cleaner Positions.
Reagent Block with 15 positions.

- (R1-R3) for 15ml reagent vials (left and right position stirred)
R1-R15
- (R4-R15) for 5ml reagent vials. The reagent block can be
removed from the working plate for external cooling.
C1-C8 8x Control & Calibrator Positions.
To place control and calibrator vessels, the Analyser uses the

controls/calibrator positions (C1-C8).

System Description
The control and calibrator positions accommodate the following tubes:
Type Volume Size Tube
Sample-Cup 4ml 61mm x 12.1mm diameter Secondary
Hitachi Cups Secondary
3.1.3 Cuvette Ring Position

The measuring module consists of:
- The Measuring rotor which has 32 cuvette positions. The temperature of

the measuring rotor is set to 37°C +/-0.4°C.
- The measuring rotor contains a triangular slot on the rotor surface for
proper ring placement (triangular arrow).
- The measuring rotor is equipped with 2 measuring channels, each
carrying a high-resolution LED photometer and reference channels, the
photometers are able to measure at a wavelength of 405nm, 570mn* and
740nm* (* depending on model type).
Figure 4 Measuring Rotor
Figure 5 Cuvette Ring

System Description
NOTE
When placing the cuvette ring into the measuring rotor make sure the
triangular markings of the cuvette ring match the same direction as
the triangular slot on the measuring rotor and the cuvette ring is
pushed all the way down.
Each well of the cuvette ring contains a 1 x 4 mm stir bar. These stir bars
are necessary to obtain accurate measurements due to generating a
homogeneous distribution of the plasma and the reagent. These stir bars
are driven magnetically by motors underneath the measuring rotor.
Only use the original cuvette bars and stir bars provided by the
NOTE
manufacturer to operate the system, otherwise you may risk wrong
measuring results and the warranty becoming null and void.
3.1.4 Sample Area

For placing samples into the analyser use the sample positions on the
working plate. Primary tubes and sample cups can be placed into the STAT
and sample positions.
Figure 6 Sample Area
1-3 3x STAT Positions.
S1 - S11 1x Sample Rack contains sample positions 1-11


System Description
The STAT and Sample Positions accommodate the following sample tubes:
3ml 66mm x 11.5mm diameter

Sarstedt  Monovette  Primary
2.7ml 65mm x 10.3mm diameter

Terumo  Venoject  Primary
4,5ml 75mm x 12.3mm diameter

Beckton Dickinson Vacutainer Primary
Hitachi 2ml Primary
Sample ID can be introduced to the analyser using an external

NOTE
barcode scanner. See chapter 4.3.5 Connecting a Barcode Scanner
(option) and 5.2.3 Load Samples to read how to connect and operate a
barcode scanner.
3.1.5 Dilutor
The analyser is equipped with a dilutor module fitted with a 250µl syringe and
a selection valve, which switches between dispensing and rinsing mode.
Figure 7 Dilutor Module

System Description
3.1.6 Pipettor
The Pipettor automatically executes all test preparations. It aspirates sample
plasma (as well as standards and controls) from the sample positions and
pipettes it into a measuring cuvette. It then aspirates one or more reagents
from reagent vials, placed in the reagent block or controls/calibrator area and
dispenses these into the measuring cuvette.
To prevent contamination, the pipettor is rinsed in the rinsing station after

each pipetting step.
The pipettor is a capacitive pipetting device heated at 37°C which is capable

to move into three directions:
- X-Direction: left and right

- Y-Direction: up and down
- Z-direction: backward and forward
Figure 8 Pipettor
3.1.7 Rinsing System

The rinsing system is used to clean the pipettor and the tube system. It
contains of a rinsing station, two pumps (distilled and waste pump), a dilutor
and two containers (distilled water, waste water). The containers can be
placed behind or beside the analyser
The distilled water container is marked with a green label, whereas the waste
container is marked with a red label.
dist waste
water water
Figure 9 Container and level sensors for distilled water (green)

and waste water (red)

System Description
Both containers are fitted with level sensors. When distilled water is empty or
when the waste water container is full, an appropriate message displays on
the screen.
The levels of the liquids will be checked:
- upon leaving the run preparation menu

- prior to the start of a run
- during the run
- prior to the start of a calibration
The distilled water tube is internally connected via the distilled water pump to
the dilutor valve. Distilled water is used as the system liquid and for
washing/rinsing of the pipettor. The rinsing solution is supplied to the rinsing
station and, after several rinsing cycles, pumped into the waste water
container by means of the waste water pump.
P
P
Pump
Distilled water Diluter with distilled Rinsing- Waste water
container water pump station container
Figure 10 Rinsing System
Besides the rinsing solution the analyser offers two positions within the
reagent area, see section Reagent Area, used to place vials with Cleaner
and or Washing Solution.
The Washing Solution is used during intensive rinsing to clean the pipettor
from thrombin containing reagents (thrombin in activator).
The Cleaner on the other hand is used to clean the system to prevent the
growth of algae and bacteria and to remove possible contamination (mainly in
the waste water system and pipettor).

System Description
There are different types of rinsing programs available:
Type Cycle description
Flush 10s System water, 10 sec. rinsing
System water, 1 sec. rinsing

Rinsing
(only available in Reagent Setup)
Washer 1 (Pos. W1)
- 3 sec. rinsing with system water
Intensive 1 - 150µl Washer 1
- 3 strokes up to 250µl
Washer 2 (Pos. W2)
Washer 1 (Pos. W1)
- 1.5 sec. rinsing with system water
Intensive 4 4 sec. rinsing with system water
Cleaner ( Pos. W2)

Cleaning Cycle
- 200µl Cleaner
(replace Washer 2)
3.1.8 Peripheral equipment and mains

connection
In general no additional equipment is necessary to operate the analyser.
The integrated module and system software controls the system and
manages all data handling. However, for external data transfer and storage
of parameters and results the analyser is equipped with several interfaces.
Using these interfaces the analyser can be connected to an external

computer using either the RS232C interfaces or the integrated LAN
interface. Measured results, reagent and test-specific data, software
screens can even be printed by means of an external USB printer device
connectable to the analyser or stored by on an USB memory device.
The backplane of the analyser carries the mains supply connection. The
instrument is designed for mains supply voltages between 100V and 240V,
at 50/60Hz.
The analyser mains isolation switch is above the power supply connection.
This is accommodated in a housing that also carries the fuse holder and the
power supply selector.

System Description
The analyser is delivered without power supply cable. The cable

NOTE must meet the local regulations. (e.g. IEC 320, VDE, CSA-C22.2, No.
21 and No. 49).
The recommended length is 1.5 m, and the minimum cross section 3x
0.75 mm2. A cold device plug is used at the system’s end.
Use only fuses recommended by the manufacturer. Observe the
instructions on the plate located on the back side of the analyser (see
picture below). The analyser is set to 230V by the manufacturer,
change fuses (supplied in accessories) in power filter, if analyzer will
be operated in 115V, see chapter 6.2.4 How to change fuses.
Figure 11 External interfaces (rear view)
Power Filter, contains:

- Fuse holder
1-
- Power Switch I = ON, O = OFF
- Mains Connection
2- DC BC-Scanner (Power connection external Barcode Scanner)
3- Extern. BC-Scanner (Serial interface Barcode Scanner)
4- USB Printer (External printer interface)
5- LAN Interface
6- 2x RS 232C interfaces (Com 1 / Com 2)
7- Waste Water (Connection for Level Sensor red)
8- Dist. Water (Connection for Level Sensor green)

System Description
3.2 Software
The operating system software interface allows the user to operate the
analyser as an independent measuring instrument without any peripheral
equipment.
The analyser software is stored in a ROM and is started after the instrument
is switched on. It controls the analyser through the start-up initialization and
controls all functions for analyser setup and the analysis programme.
Some analyser software application areas are protected with an additional

PIN code (password). After inputting a pre-defined PIN code, other software
levels licensed to the authorised user may be accessed; these enable the
setting and adjustment of additional instrument and test/reagent specific data or
parameters.
Without access to the requisite PIN code, these software levels remain locked.
The next software level (expert level) has been set to default level 12345 by
the manufacturer. This may be amended at any time, see Chapter 5.3.9
Change Password
User Interface
The dialogue between analyser and user takes place via the built-in touch
screen, refer also to chapter 3.1.1 Touchscreen.
The menus and menu items are selected by pressing the surface of the
user control panel either by a finger tip or a blunt object, like a touch screen
pen designed for this purpose.
Never use a sharp object (finger nail, knife, letter opener) to press on
NOTE the control panel as it might cause irreparable damage to the control
panel surface.
To operate the analyser software different kind of menus, buttons, boxes

and displays are available to select certain menus and functions, to enter
information and parameters and to display results, analyser information and
to view graphics.
The following pages provide further information on available menus,

software areas, functions and defines the functionality of the analyser
software by using the touch sensitive colour display.

System Description
3.2.1 Software control via touch screen
Figure 12 Main Menu functions
Displays associated functions combined in sub-

1- Area Frame
menus or titles specific software areas.
Are used to access additional menu / software

2- Buttons
areas, to confirm entry or to exit a screen.
Displays active or inactive functions, date & time

3- Status Line information, individual messages, irregularities
and problems occurred during measurement.
To enter information using the virtual keyboard.

By pressing onto the white input fields a
4- Input Field
keyboard opens, allowing either alphanumeric or
only numeric entries.

System Description
Figure 13 Area frame, scroll buttons, select window
Displays associated functions combined in sub-

1- Area Frame
menus or titles specific software areas.
Are used to scroll up and down within a screen to

choose between certain available selections.
2- Scroll buttons
Single arrows allow movement by one line
Double arrows allow movement by window/page
Are used to access additional menu / software

3- Buttons
areas, to confirm entry or to exit a screen.
4- Select Window Displays available selections to choose.

System Description
Figure 14 Select box, Check Box
Select between individual options by pressing the

1- Select Box
arrow buttons.
To set individual parameters On/Off by pressing

onto the coloured field.
2- Check Box
OFF= light blue
ON = dark blue

3- Input Field

System Description
Figure 15 Movable Window
Information on windows not being displayed in

total may be moved by keeping the finger onto
Moveable
1- the screen and then moving up/down and
Window
left/right. The window will move according to the
fingers direction.
Are used to scroll up and down within a screen to

choose between certain available selections.
2- Scroll buttons
Single arrows allow movement by one line
Double arrows allow movement by window/page

3- Input Fields

System Description
Figure 16 Movable Window (Graph)
Graphs of calibration and reaction curves not

Moveable being displayed in total on the screen may be
1- Window moved by keeping the finger onto the screen and
(Graph) then moving up/down and left/right. The window
will move according to the fingers direction.
Figure 17 Message Box
Provide information, Messages on Errors,

1- Message Box
Warnings and further available functions.

3.2.2
MAIN MENU
Run Preparation Measurement Results / Run Results / Memory Status Shutdown Setup CuvCARD
System Description
press press press press press press press press

button button button button button button button button
Software Overview
Load C-Ring Start the run Results of last run Results Storage Analyzer status Switch off analyzer Passwords Load C-Ring balance
- Load new cuvettes - Start measurement - Show joblist results - Show all results - View analyzer status - Switch off - Edit/print Password/PIN
- View reagent list - Print joblist results - Show results by sample - Print analyzer status - Restart
Load Reagents - View cuvette info - Show results by test - Show version info (quit) Reagent Setup
- Load tests - View sample info - Display curve graphs - Define reagent set up
- Set reagent vial size - Show joblist - Print results / graphs - Print reagent set up
- Re-new reagents - Print joblist
- Remove reagents Date & Time
- Define positions ... during run
- Set up date & time
- Add STAT runs
Load Samples - Show analyzer status Im / Export data
- Load patient samples - Stop/interrupt run - Im/Export parameters
- Edit /enter patient ID - Show reaction curves - Update Software
- Select sample vial - Print reaction curves
- Clone mode - Show results Selftest
- Prepare joblist - Initiate analyzer selftest
Rinsing Modes Test Setup
- Flush - Define test set up
CoaLAB 1000 – Operators Manual 1.1

- Intensive wash - Print test set up
- Cleaning
- Maintenance Calibration
- Set STAT Autoprint - Edit calibration of test
- Define Working Modes - Enter calibration curves
- Set Beeper - Auto calibration
- Define Headline - Print calibration data
Delete Results
- Delete results storage
Page 28
Language
- Set analyzer language
System Description
3.2.3 Program Menus

This section gives an overview about the available software menus and
software areas to provide a quick guideline thought the overall analyser
software. See chapter 5.2 Routine and 5.3 Setup Menu for an accurate
description of the detailed software functions.
3.2.3.1 Main Menu

The Main Menu automatically appears after the analyser has been switched
ON and the initialization process of all analyser modules has successfully
been finished. Sometimes you must confirm a message, e.g. about the
Shield Control being disabled first.
Figure 18 MAIN MENU
The Main Menu is separated into two main sections
Menu Button Function
Within this area all submenus related to run

Measurement Area preparation, measurement, result organization
and status information are located.
Within this area all submenus related to general

Setup Area analyser setup, reagent and test definition and
calibration settings are located.
By pressing into the input field a numerical
keypad opens allowing the entry of a PIN Code
Password/PIN
enabling access to other available software
levels.
By pressing the reset button you will reset the

Reset
PIN Code to the lowest available access level.
Switching off the Analyser or reboot the

Shutdown
system.
Submenus of the Main Menu are described in the following sections.

System Description
Measurement Area
Run Preparation
Figure 19 Run Preparation
Load C-Ring Load of cuvette ring into the measuring rotor.
Displays the reagent load window, the positioning of

Load Reagents reagents and washers in the reagent area and
selection of usable reagent/washer vials.
Displays the sample and STAT load window,
Load Samples positioning of samples/STAT and selection of
sample tubes usable.
Selection of available rinsing, washing and cleaning

Rinsing Modes
cycles.
OK Return to MAIN MENU

System Description
Measurement
Figure 20 Required Reagents
Reagent Status Displays joblist information according to reagents

List and washers available and needed.
Information about the cuvette ring, start cuvette,
Cuvettes required, cuvettes to run measurement and available
cuvettes in total.
Information about the samples to be measured, fully

Samples
and partially processed samples.
Selection of additional functions, like displaying

Tools
joblist and timeline, printing the display
Start the Run Button to initiate the measurement
Exit Return to MAIN MENU

System Description
Results
Figure 21 Short form Results
This window displays results of the last run in an abstract form only. This list
will be deleted as soon as new results are available out of a next run. See
chapter 5.3.4.4 Define Results/Run list to define the result information
shown in this window.
Print To print short form result list via an external printer.

System Description
Ring Storage
Figure 22 Result Selection
Shows all available results of the result storage in a

All
list
Shows all available results of the result storage
Sample
sorted by sample.
Shows all available results of the result storage
Test
sorted by test.
Figure 23 Result/Memory

System Description
Status
Figure 24 Status Menu

Displays the analyser status concerning
temperatures of rotor and pipettor, Container Status,
Display cuvette ring information, irregularities in the results
Information measured as well as other errors appeared during
measurement. Any problems occurring may be
marked colored.
Print To print the Status Screen

System Description
3.2.3.2 Setup Menu
Setup
Figure 25 Setup Menu
Certain areas within the Setup may only be accessed by entering a PIN
Code in the Main Menu. The software indicates the level of password
required accessing into another level, see chapter 5.3.9 Change
Password.
Menu Button Function Software Level
Passwords To set passwords to access different software level. Expert
Reagent Setup To define and edit reagent specific parameters Anyone
Date & Time To edit analyser date & time. Anyone
Im/Export To im/export test & reagent parameters via USB Stick. Anyone
Initiates an automatic self test procedure of the
Selftest Anyone
analyser.
To define and edit test specific parameters. To
Test Setup Anyone
combine individual reagents.
Perform calibration and management of calibration
Calibration Anyone
data, curves.
Delete Results To delete all results of the ring memory Expert
To import other languages via USB Stick, reset
Language Anyone
language to factory default.
Check Box to activate/deactivate automated print of
STAT Autoprint Anyone
STAT parameters
Select Box to select whether the measuring run shall
Working Modes Anyone
be by sample or by test
Check Box to activate/deactivate acoustic signals
Beeper Anyone
performed by the anlyser.
Headline Defines print headline Anyone
Tools Access to other functions Anyone
OK Return to MAIN MENU Anyone

System Description
3.3 Measuring Principle
The analyser uses a photo-optical detection principle. Clotting, chromogenic

and immunologic assays can be run simultaneously in random access,
depending on the available wavelength installed in the analyser.
The measuring module consists of the measuring rotor having two

measuring channels each equipped with LED photometer. Depending on
the analyser there are either
- 2 LED photometers with a filter 405nm only or

- 2 LED photometers with filters at 405nm/570nm/740nm
Test cuvette
LED Photodiode
perm. magnet
Stirrer - Motor
Photometer
Electronics
Display
Figure 26 Measuring Principle
A light beam passes through the cuvette and is received by the photodiode.
As soon as the starting reagent is added to the plasma, the measuring time
starts.
Any change in the light transmittance is detected and converted into an

electrical signal by the photodiode.
When the assay is complete, the raw data (seconds for coagulation assays
and mE/sec (Extinction) for chromogenic assays) are processed and
reported.

System Description
3.4 Reagents
For proper coagulation analysis we recommend the use of reagents,

controls and buffers from recognised manufacturers. Always read the
information leaflet in the pack and observe the instructions given by the
reagent manufacturer.
Utilize reagents and controls only according to directions as provided

NOTE
by the reagent manufacturer to avoid incorrect measuring results or
malfunctions of the analyser.
Contamination
With the application of different reagents, and here especially reagents
containing thrombin, there is a danger of reagent carry-over.
NOTE When adding reagents and samples the pipettor is exposed to

reagents and hence a point of contamination.
If liquid residue or dried-on remnants can be seen on the workplate of the

analyser, remove them with laboratory disinfectant solution and cotton buds.
Other things you may need to or

must take into consideration:
Only use the analyser according to the required ambient conditions.

NOTE Protect the measuring channels from direct sunlight or other light
sources.
Always place a cuvette ring in the measuring rotor before pipetting.

Ensure each cuvette is equipped with a mixer. Pipetting reagent or
sample into the measuring vials and or tubes can significantly
contaminate the analyser and could even render it faulty, so that
expensive cleaning or repair might become necessary.
Only use the original manufacturer’s cuvette rings and mixers as they
are subject to strict quality control. The use of other makes of cuvette
rings and any associated instrument problems as a result, will
invalidate your guarantee.
Use cuvette rings once only. Multiple use of cuvette rings may
produce incorrect results; this in turn can become an indirect hazard
for the patient.
Perform regular quality control checks. Please refer to the guidelines

of use provided by the reagent manufacturer.

System Description
3.5 Load Cuvette Rings to analyzer

(depending on model)
To guarantee safe, correct and precise coagulation analysis the

manufacturer has executed extensive trails and studies concerning the
analyser and its related original cuvettes and mixers. To ensure proper
coagulation analysis of the system even in the routine work the use of
original cuvettes and mixers, as provided by the manufacturer, is required.
Depending on the model type the analysers are equipped with a cuvette
management system, which allows loading of a cuvette ring credit balance
of original cuvette rings to the analyser, by means of a cuvette card, so-
called CuvCARD. The individually loaded cuvette ring credit balance
enables the analyser to perform coagulation measurements in the same
quantity of cuvette rings as loaded on the analyser.
At first delivery the analyser is preloaded with a cuvette ring balance

NOTE
by the manufacturer corresponding to the quantity of cuvette rings as
delivered in the accessory box, i.e. 10 cuvette rings (320 single
cuvettes).
Each cardboard box of original cuvette rings (containing 6 boxes of 10

cuvette rings), suitable for your analyser, is also equipped with a
corresponding CuvCARD. This CuvCARD, as you will find in the cardboard
box, carries a quantity of 60 cuvette rings. By using this CuvCARD you can
load the cuvette rings, 10 at a time, to the analyser.
Once the cuvette ring credit balance is fully used, meaning if measurements
of the same quantity of the loaded cuvette ring balance have been
performed the analyser will automatically request for re-load respectively
reminds you to order new cuvette rings.
As far there is still a cuvette ring credit balance on the CuvCARD,

NOTE
keep the CuvCARD safe. Loss or damage of the CuvCARD would
waste the cuvette ring balance on the Card.
The cuvette ring balance once loaded to the analyser will only be
NOTE
deducted when the sample plasma has been added to the cuvette. If
the run is stopped before this time the cuvette is not deducted.
However, once sample plasma is added to a cuvette the cuvette is
considered being used and the counter will deduct it from the loaded
cuvette ring balance.

System Description
The following describes how to load cuvette ring balance from a CuvCARD
to the analyser.
• At first insert the CuvCARD into the CuvCARD reader slot with the
memory chip facing down and in the direction of insertion. Leave the
CuvCARD in the reader, see picture below.
Figure 27 CuvCARD/ChipCARD Reader
• From the Main Menu, press the button CuvCARD to access cuvette
ring loading procedure.
The following display appears:
Figure 28 Message: Load CuvCARD

System Description
• Confirm this message by pressing the button YES if you intent to load a
cuvette ring balance of 10 new cuvette rings to the analyser.
• By pressing the button No you will leave this message box without
loading any cuvette ring balance.
After confirming above message box by pressing the Yes button and in
case the analyser still carries a cuvette ring balance the following
ATTENTION message box appears:
Figure 29 Message: Overwrite loaded balance
When loading a cuvette ring balance from the CuvCARD to the

NOTE
analyser, the remaining balance eventually still on the analyser will be
overwritten. Make sure the balance on the analyser is fully used prior
of loading a new balance from the CuvCARD to avoid any waste of
cuvette rings.
• By pressing the button No you will leave this message box without
loading any cuvette ring balance. The existing balance will be kept
available the following message appears:
Figure 30 Message: No C-Rings loaded

System Description
• Confirm this message by pressing the button YES if you intent to load a
cuvette ring balance of 10 new cuvette rings to the analyser.
The analyser starts the loading procedure from the CuvCARD; make sure
the CuvCARD is in the CuvCARD reader during the complete loading
process.
Once the cuvette ring balance is loaded, the following overview appears:
Figure 31 Message: Overview of loaded C-Rings
The overview table provides certain information on the loading status of the
cuvette rings loaded to the analyser as well as status information of the
CuvCARD balance remaining.
Print
• Press the Print button to print the Overview of loaded C-Rings window.
OK
• Press the OK button to leave this window.
Disposal of the CuvCARD may be done in the domestic waste after

NOTE the cuvette balance on the CuvCARD is fully used and the CuvCARD
is devalued.
Please refer to chapter 6.2.3 Errors during operation further

NOTE
information on status messages generated by the CuvCARD handling.
Refer to chapter 5 OPERATION, to continue with measurements.

Installation
4 INSTALLATION
This chapter provides instructions on how to unpack, install and prepare the
analyser for use.
Before performing any tasks in this chapter, review the Hazard and
NOTE
Precautions listed in chapter 2 of this manual.
4.1 General Setup
Remove the analyser from its packing and verify that the instrument has not
been damaged during transport and the accessories are complete, see
chapter 7.1 Materials supplied. Please notify your distributor or the
manufacturer immediately in the event that the shipment was damaged or
incomplete.
• For the safety of the instrument and yourself the analyzer should be
carried or moved by two persons.
To carry the analyzer use the handles located on the left and right bottom
side of the analyzer.
Figure 32 Carry handles
• Make sure a stable and level area for installation was selected and the
installation area is free from dust, liquids, solvents, gas and acid vapors.
• There should be free space of min. 15 cm around the analyser having free
access to the interface panel and power switch in the rear of the analyser
and to install the liquid containers.
• Lift the system from the box (with assistant), and place on the installation
area.
• Remove all foam inserts and set aside.
Pay attention to the pipettor!

Be careful not to damage the pipettor, flat cable and steel tubing; any
damaged or defective parts must be replaced by a service technician before
operating.

Installation
• Place the system in the correct position on the table.
• Remove all tapes and transport protection devices.
• Make sure the power cable will reach the outlet without using any
extension cords.
• There should be enough light for proper operation, but no direct sunlight
and artificial light, e.g. lamps.
• The ambient temperature must range from +15°C to a maximum of +

30°C. Avoid significant temperature changes, humidity and voltage
variations, see chapter 7.4 Technical Data.
The analyser should be placed in an area that allows access to the

NOTE main switch at all times. In case of any emergency, it may be
Ensure there necessary to immediately switch off the analyser.
NOTE
The analyser power cord must comply with the national standards in
the country the equipment is supplied.
Do not damage any packaging material, and keep them for possible
NOTE later use, including the transport protection devices. Store them
away from heat and humidity.

Installation
4.2 Removing the Transport

Protections
The analyser is secured with several transport protection parts to avoid any
damage of the analyser or components during its transportation.
Prior of use the analyser has to be released from any of these transport
protection devices.
Transport protection devices are:
1. Cardboard insert inside transfer arm: Protecting the pipettor from

moving in Z-direction.
2. Cardboard insert backside: Protecting the pipettor transfer arm from
moving in X-direction.
3. Red plastic plate with cable ties: Protects the pipettor from moving in Y-
direction.
4. Empty red cuvette ring in the measuring rotor to protect from
contamination of the measuring cells.
4.3 Assembly of the analyser
Before connecting the analyser to the main power supply, complete all
instructions in this section.
4.3.1 Mount the diluter syringe

Mount the 250 µl dilutor syringe to the dilutor of the system according, see
figure below. When properly mounted, the syringe should not be wedged,
and must be watertight.
For Installation proceed as follows:
• Push down the piston holder with two fingers.

• Insert the syringe with the piston in the holder.
• Tighten the piston holder slightly.
• Pull the syringe cylinder upwards.
• Screw the cylinder into the diluter valve.
• Tighten the piston holder.
Figure 33 Mount of Dilutor Syringe

Installation
4.3.2 Connecting the Rinsing System

The analyser is equipped with two water containers (distilled water and
waste water). All containers should be located to the left side, behind the
analyser. The distilled water temperature may not exceed the specified
temperature of the analyser (+15°C to + 30°C)
• Place the distilled water container (with the green label) and the empty
waste water container (with the red label) to the left rear of the analyser.
Fill the distilled water container with at least 1 Liter of distilled water.
• Place the colour-coded sensors into the appropriate containers (green

for dist. water, red for waste water). Ensure there are no air bubbles in
the tubing of the distilled water container, or in the container itself.
• Plug the green and red colour-coded couplings into their matching
sockets on the back of the system (see figure 11). A „click“ indicates the
proper seating of the connectors.
The system will only function if the distilled and waste water tubes have
been connected properly to the system.
NOTE The system must be switched OFF.
The couplings are color-coded:

red for
waste water
green for Re
d
dist water
Gr
ee
n
< NOTE >

Decoupling of the tube adapter
Press on the metal shield to

release the tube adapter.
Figure 34 Connect the level sensor tubes to the analyser

Installation
The distilled water container must have at least 1 Liter of distilled

NOTE water. The waste water container should be emptied every day. Be
careful not to have air bubbles in the distilled water container as well
as in the tube.
The distilled water container may not be placed in direct sunlight.
Container
dist
water
Figure 35 Container for distilled water. Container and tubes are coded with
green.
waste
water
Figure 36 Container for waste water. Container and tubes are coded with
red.
4.3.3 Connecting an UBS Memory Device

The analyser is equipped with two USB interfaces. While one USB interface
is located at the rear side of the analyser utilized for connecting an external
printing device the second USB interface can be found at the right side of
the analyser within the carrying handle, see figure below.
Figure 37 USB-Stick Interface

Installation
This interface offers the option to connect a USB memory device to record
and save measuring data, i.e. results, reaction curve and patient data and to
import and export test and reagent specific data using a commercially
available USB stick. These data can be viewed later on the display of the
analyser.
To record measuring data first insert a USB Stick into the USB interface
located as shown in figure 37. Leave the USB Stick in the interface, the
USB Stick will me mounted once the analyser is switched on.
The USB Stick should have a memory of at least 1GB.
4.3.4 Connecting an external printer

The analyser offers the possibility for connecting an external USB printer
device using the USB interface at the rear side of the analyser; this allows
print put of results, reaction curves, instrument- and test parameters.
• To connect the USB printer device use the USB cable provided in the
accessories of the printer. Use the corresponding USB interface in the
rear of the analyser to connect the printer to the analyser.
• Connect the power supply plug to the printer.
• The analyser will automatically detect the USB printer once connected
to the analyser. To verify the connection is set correctly the symbol print
in the status line of the analyser must turn green, see figure below.
Recommended printer types / interface parameter settings:
Interface Manufacturer Type/model

USB Hewlett For example:
Packard Deskjet 6940, Deskjet D5560, Officejet
6000
Specifications:
- USB interface
- Support of PCL 3 printer protocol
Observe the printer manufacturer’s operating instructions,

NOTE
including the default interface parameter settings.
Figure 38 Status Line with active print

Installation
4.3.5 Connecting a Barcode Scanner

(option)
• Connect the optional barcode scanner to the analyser. Use the

recommended type only.
• Connect the barcode scanner data cable to the RS232C socket (marked
Extern. BC-Scanner) on the analyser (see figure 11 No.2/3).
• Plug the power supply into the socket (marked DC BC-Scanner) next to
it.
4.3.6 Connecting a Personal Computer

(for Service only)
The analyser is equipped with two serial RS 232C interface ports on the
rear side of the analyser.
Com 1: This interface is used for manufacturer operation only.
Com 2: This interface is used for service operation only.
• Before switching on the computer, the PC must have been connected to

the external periphery instruments. Use the data cable recommended
by manufacturer or dealer only. Then connect the PC to the power
supply. Do not switch the computer on yet!
• Now connect the data cable to the socket (marked Com1 or Com2) at
the back of the analyser and to the interface port of your computer.

Operation
5 OPERATION
This chapter provides a step-by-step introduction to routine operation of the
analyser.
Before performing any tasks in this chapter, review the Hazard and
Precautions listed in chapter 2 of this manual.
NOTE
5.1 System Start-up
To keep the information on routine operation as simple as possible, this

chapter contains basic information. Detailed information on the individual
menus and screens is located in 5.2 Routine Menu.
After installation use the following procedure to start up the analyser.
5.1.1 Switch On
Set the power switch on the back side of the analyser to the position I = ON,
see also figure 11.
The analyser now runs through a full initialization procedure checking all
internal modules automatically. The following describes the sequence of the
initialization procedure:
Figure 39 Message: Shield Control
NOTE
Above message box appears only if the shield control is disabled in
the software. For operational and for biologic safety reasons it is
recommended to always have the shield closed until a run is
finished or interrupted.
• Confirm this message box by pressing the OK button.

Operation
Figure 40 Message: Insert Cuvette Ring
In case the system still carries a cuvette ring in the measuring rotor above
message box appears. This message indicates the number of used cuvettes
in the cuvette ring.
By pressing the button YES a new unused cuvette ring must be inserted into
the measuring rotor first.
By pressing the button No the cuvette ring still in the measuring rotor will be
further used.
• Confirm this message box by pressing Yes or No according to the

corresponding action.
After confirming above message box or if no or a new cuvette ring has

already been inserted the following display appears.
Figure 41 Analyser Status Message

Operation
During the initialization procedure the analyser beside other modules also
checks the status of the liquid system, meaning the function of the DI pump,
waste pump and level detection.
Figure 42 Pump Test
This procedure will be repeated three times if any liquid levels deviate from
the expected values, e.g. due to any malfunction of the pumps and level
detection or if the analyser is taken into operation the first time after initial
setup when the liquid system is not yet filled up with system water.
In seldom cases if the liquid system can not be filled up during this
procedure or due to any malfunction of the pumps and level detection the
following message appears:
Figure 43 Pump Test failed
By pressing the button OK the analyser allows access to all menus but locks
all areas required to perform any measurements due to safety reason.
In this case confirm this message by pressing the button OK and repeat the
initialization procedure once again.
• Switch off analyser by pressing the button Shutdown and press Restart
to again start the initialization procedure.
If the problem persists check chapter 6.2 Troubleshooting for further

information.

Operation
After successful pump and level detection test the following message
appears:
Figure 44 Pump Test OK
Once the initialization process is finished the MAIN MENU appears in the
display.
Figure 45 MAIN MENU
5.1.2 System Liquids

Before starting a routine run operation:
• Check the level of the distilled water container.

• Empty the waste water container.
When the distilled water container is empty, use the following procedure:
• Fill the distilled water container with distilled water at room temperature,
see also chapter 4.3.2 Connecting the Rinsing System.
• Place the two level sensors in the containers making sure that the colour
of each level sensor matches its corresponding container.

Operation
5.1.3 Fill liquid system and flush system

For transport safety reasons the analyser has been delivered in dry
condition, meaning without any system liquids. Before using the analyser it
is necessary to perform a rinsing process to fill all system modules with
liquid (pumps, dilutor and tubing’s). This procedure shall also be performed
to clean and remove any air bubbles in the tubing. Further you can check
whether all tube and screw connections have been installed properly.
Should you notice any leaking, tighten the connections to the point
NOTE
that they are watertight.
• From the Main Menu, press the button Run Preparation the following
display appears.
Figure 46 Run Preparation Menu
• Use the Select Box arrow buttons in the “Do Washing Cycle” frame until
Flush 10s appears in the select box.
• By pressing the button Perform the flush/rinsing procedure starts. The

analyser will rinse the system with distilled water.
• After the initial installation this procedure should be repeated at least 5

times until the tubing is completely filled with system liquid and the
tubing is free of any air bubbles inside the tubing.
• Check the system again for any leakage’s and re-mount, if necessary,
all connections and tubes before repeating the rinsing cycle.
Daily Maintenance
On a daily maintenance basis it is recommended using the above described
procedure even to clean and remove possible air bubbles in the tubing (if
system has already been used).

Operation
5.2 Routine Menu
Following system start-up, the analyser is now ready for routine operation.
The next chapters describe how to:
- Load and replace a cuvette ring

- Load Reagents & samples
- Start Measurements
- Show/print results
- Handle the result ring storage
- Show/print reaction curves
- Display the analyser status
5.2.1 Load/Replace Cuvettes

This chapter describes how to load and replace a new cuvette ring and
handling of a used cuvette ring.
• From the Main Menu, press the button Run Preparation to access the
run preparation area.
• From the Run Preparation Menu, press the button Load C-Ring the
following display appears.
Figure 47 Load C-Ring
Perform one of the following:
Option 1:
1. If applicable first remove any used cuvette ring from the measuring rotor
if this ring can not or shall not be further used.
2. Afterwards or in case there is no cuvette ring, insert a new cuvette ring

into the measuring rotor. Check chapter 3.1.3 Cuvette Ring Position to
ensure correct insertion of the cuvette ring and ensure a cuvette ring
balance is loaded to the analyser, see chapter 3.5 Load Cuvette Rings
to analyzer (depending on model).
3. Press Done to confirm the cuvette ring has been correctly inserted.

Operation
After pressing the button Done an Info message box appears showing the
remaining balance of cuvette rings available on the system. When loading a
new cuvette ring and confirming this procedure with Done will deduct a
loaded cuvette ring from the cuvette ring balance available on the analyzer,
see chapter 3.5 Load Cuvette Rings to analyzer (depending on model).
Figure 48 Remaining C-Ring balance
Each load of a new cuvette ring will deduct one ring from the loaded
NOTE
cuvette ring balance after confirming with Done.
Make sure first that all cuvettes of a cuvette ring already in the
measuring rotor have been fully used before loading a new cuvette
ring. Otherwise you may risk wasting unused cuvettes.
Option 2:
1. If there is a partly used cuvette ring inside the measuring rotor you may
decide to further use this cuvette ring until all cuvettes are consumed. In
this case press Quit to continue.

Operation
5.2.2 Load Reagents

run preparation area.
and/or
• From the Run Preparation Menu, press the button Load Reagents the
Figure 49 Load Reagents
This display offers information on currently loaded reagents and required

washers and provides access to certain other menus needed to set up and
load reagents.
Load Test
• By pressing onto the not used buttons (---) a list of selectable tests will
be opened.
Figure 50 Test Select List
• Use the scroll-up and down buttons to move up and down inside the
displayed list. The selected test will be highlighted, example APTT.
• Once a test (here APTT) is selected press OK to confirm selection. By

pressing ESC you will leave this window without any test selection.

Operation
Required Reagents
The selected test will be shown in the Load Test list as well as in the
Required Reagents section, see example APTT.
Figure 51 Reagent/Washer Table
The Required Reagents Table is an exact reflection from the reagent area of
the analyser. It assigns the positions to where the reagents have to be
placed on the analysers, see chapter 3.1.2 Working Plate.
• Place the reagents in the assigned position on the analyser

corresponding to the positions as shown in the display, example APTT
reagent = R4, CaCl2 = R5.
Make sure to always place the reagents exactly on the same position
NOTE
as shown in the display to avoid any failure in your analysis.
Crossed out and grey fields, e.g. R1 show free not used positions on
the Reagent Area.
None crossed out and grey fields, e.g. R2 (PT) show already used
positions and the reagent assigned to it.
Required Washer
It is mandatory to always load washer on the analyser! The Washer
position W1 will be checked prior to each run. If a washer is detected during
the reagent check procedure the corresponding position will be displayed in
the Required Washer Area on the screen. Not used Washer positions will
be crossed out.
• If not yet done place a vial containing washing solution on the Reagent
Area.

Operation
Change reagent positions and vial

size (Vials button)
• By pressing the Vials button the following window appears:
Figure 52 Vials Menu
The following options are available:
Renew Reload or refill reagents or washer by pressing on the reagent or washer

position you intend to reload. Crossed out fields can not be accessed.
The selected reagent or washer position will be highlighted, example PT.
Figure 53 Vials Menu Example: PT
• If you intend to reload or refill a reagent or re-set the reagent stability

times press the Renew button and a message box to renew the reagent
appears.
• If you intend to reload or refill a washer only press the W1 (not crossed
out) button and a message box to renew the washer appears.

Operation
Figure 54 Message: Renew Reagent
• Replace or refill the assigned reagent or washer in the Reagent Area

and confirm this message by pressing the OK button.
• The levels of the replaced/refilled reagents or washers will be detected

again by leaving the Load Reagent Menu with the Save&Exit button.
Make sure to place the reagents and washers always in the assigned
NOTE
position on the analyser. Otherwise you risk failure in your analysis.
Change reagent position To change a certain reagent position in the Reagent Area press on the
reagent you intend to change. Crossed out fields can not be accessed.
The selected reagent will be highlighted, example PT as shown in figure 50.
• Press the change Pos button and the Target Position Menu appears.
Figure 55 Change reagent position
This window provides information about the reagent position still available
for changing. All none visible positions are already used by loaded reagents
or the selected vial size does not fit into the hidden target position.

Operation
• Select one of the available reagent positions by pressing on the

corresponding button, example R1. The reagent will be moved to the
selected position, the following display appears.
Figure 56 Target Position
• PT has now changed to position R1. Move the PT vial in the Reagent
Area to the new assigned position.
Make sure to place the reagents and washers always in the assigned
NOTE
position on the analyser. Otherwise you risk failure in your analysis.
Change reagent vial size To change another size of a reagent vial, for example if reagent bottles of
certain reagent manufacturers are used press again on the reagent you
intend to change the vial size. Crossed out fields can not be accessed.
The selected reagent will be highlighted, example APTT.
Figure 57 Change vial size

Operation
The loaded reagent positions are framed by different colours. Each colour of
a frame indicates the vial size selected corresponding to the frame Vials on
the right side of the display. In the Vials frame only the available vial sizes
can be selected.
The following vial sizes are available:
Reagent positions Selectable vial sizes Colour
15ml Glass Magenta

12ml Glass Green
R1 - R3
5ml Glass Yellow
4ml Plastic Blue
5ml Glass Yellow

R4 - R15 4ml Plastic Blue
Cup Orange
• Select one of the available reagent vial sizes by pressing on the

corresponding button in the Vials frame, example 4ml Plastic. The
coloured frame of this reagent will be changed according to the vial size
selected.
Tools In certain menus the Tools button offers several options and access to other
menus and actions
• Press the Tools button in the Vials Menu to access additional areas the
following Select Window appears.
Figure 58 Tools in Vials Menu

Operation
The following Tools are available:
Available Tools Description

By pressing this button all loaded reagents and
Renew all washers will be renewed and the stability timer
restarted.
By pressing this button you will leave this

Quit
window without any changes.
By pressing this button you will be asked to

Undo confirm whether all changes done in the vial
menu shall be confirmed or waived.
By pressing this button the vial menu screen will
Hardcopy be printed out, provided a printer is connected
to the analyser.
Save&Exit By pressing the Save&Exit button all changes in the Vial Menu will be
confirmed and returns back to the Load Reagents Menu.
Tools
Figure 59 Load Reagents
The Tools button in the Load Reagent Menu offers several options and
access to other menus and actions.
• Press the Tools button to access further additional areas the following
Select Window appears.

Operation
Figure 60 Tools in Load Reagents

By pressing this button the vial menu screen will
to the analyser.

Quit
By pressing this button a previously selected

Remove test
test in the Load Test list will be removed.
By pressing this button all test in the Load Test

Remove all list incl. all run-settings for each test will be
removed.
Save&Exit By pressing the Save&Exit button in the Load Reagent Menu confirms all
changes in this menu and starts level check of all reagents and washers on
board.

Operation
5.2.3 Load Samples

(Routine & STAT)
Run Preparation Menu.
and/or
• From the Run Preparation Menu, press the button Load Samples the
Figure 61 Load Samples
Within this menu the complete sample handling can be controlled and set. It
further provides information on currently loaded samples, samples to load,
selectable sample cups/tubes and reagents available for each sample.
Enter/Edit Sample ID
(manually)
• Select a sample by pressing onto the sample button once, e.g. (sample
01). The sample box will be highlighted.
• By double-clicking onto the sample buttons, e.g. (sample 01) an

alphanumeric keyboard opens allowing the entry of sample/patient
names/numbers.
Figure 62 Edit Sample ID

Operation
• Use the keyboard to enter the sample/patient ID required, see chapter

3.1.1 Touchscreen for further information. For sample/patient ID entry
15 alphanumeric characters are available.
• Press the Enter button once the sample/patient ID is entered.
Figure 63 Entered Sample ID
• Entered sample/patient ID´s appear in the sample box as shown above.

If no sample/patient ID is entered sample 01…sample 22 will remain as
shown.
Enter/Edit Sample ID (with

external barcode)
Instead of entering sample ID´s manually you may also load sample ID´s by
using an external barcode scanner, see first chapter 4.3.5 Connecting a
Barcode Scanner (option).
• Select a sample by pressing onto the sample button once, e.g. (sample
01). The sample box will be highlighted.
• Do NOT enter a sample ID manually.

Samples are identified by the sample ID on the barcode label.
Depending on the type of barcode, the sample ID can be numeric,
alphanumeric or alphabetic.
• Direct the scanner window to the barcode label of the vial/tube.
• Press the button on the barcode scanner. Continue pressing the button
until a beep confirms entry of ID.
• The scanned sample ID should now appear in the selected sample box.
A large number of barcodes can be used. If the system does not

NOTE
accept a certain barcode contact the manufacturer or enter the patient
ID manually.
• Repeat described steps to enter more samples.

Operation
Select Sample Rack

The analyser is equipped with 22 sample positions divided in two racks of 11
samples plus one rack of 3 STAT positions, see chapter 3.1.4 Sample Area.
Figure 64 Sample/STAT Positions
1-3 3x STAT Positions.

• To select between the sample and STAT racks use the arrow keys as
described as follows:
Figure 65 Sample Rack 1..11

Operation
Figure 66 Sample Rack 12..22
Figure 67 STAT Rack 1..3
The Load STAT Samples window allows entry and definition of STAT
(Emergency loading) samples. These samples will be handled with highest
priority in the measurement sequence. 3 sample positions are continuously
available to initiate immediate STAT measurement. The loading of samples
as well as the loading of reagents follows the normal procedure for loading
of the samples and reagents, see chapters 5.2.2 Load Reagents and 5.2.3
Load Samples.
• To enter sample/patient ID´s precede as previously described.
• To load additional reagents for a STAT sample, refer to chapter 5.2.2

Load Reagents.

Operation
Select Sample Vial

A various selection of primary and secondary tubes/vials may be assigned to
each sample/patient, see chapter 3.1.4 Sample Area for further information.
• Press onto the sample/patient you intend to assign a sample vial/tube.

The sample/patient button will be highlighted.
• Select a vial/tube from the list as shown in the vial frame of the display,
see next figure.
Figure 68 Vial Frame
Below table shows the vials/tubes placeable in the sample area. Based on
the vial/tube used select the corresponding colour in the vial frame of the
display.
The STAT and Sample Positions accommodate the following sample tubes:
Sarstedt  Monovette  3ml 66mm x 11.5mm diameter

Primary
Sarstedt  Monovette  5ml 92mm x 11.5mm diameter
Terumo  Venoject  2.7ml 65mm x 10.3mm diameter

Primary
Terumo  Venoject  5ml 99mm x 12.4mm diameter
Beckton Dickinson Vacutainer 4,5ml 75mm x 12.3mm diameter

Primary
Beckton Dickinson Vacutainer 5ml 98mm x 12.3mm diameter
Hitachi 2ml Secondary
Make sure to place the same sized (coloured) vial/tube into the
NOTE
sample area as selected in the vial frame. Otherwise you risk failure
in your analysis or damage of the pipettor.

Operation
Once the vial/tube has been selected in the vial frame the coloured dot
beside the sample will show the assigned colour.
Figure 69 Sample with assigned vials
Assign test(s) to a sample

(joblist preparation)
To assign tests (assays) to a sample you may select out of the tests/assays
as listed in the Load Sample Menu. Within this list all tests/assays will be
shown as previously loaded, see chapter 5.2.2 Load Reagents.
• Press onto the sample/patient you intend to assign a test/assay. The

sample/patient button will be highlighted.
• Select the test/assay from the list as shown on the right side of the
display, see figure below example PT and APTT by pressing onto the
test/assay buttons.
Figure 70 Select test/assay
• Selected tests/assays will be highlighted. Repeat this procedure for all

samples you intent to assign tests/assays for.

Operation
Clone mode To make creating a joblist easier the Clone mode offers the possibility to
copy/clone certain joblist information from one sample already defined to
another undefined sample.
• If you intend to clone a sample press first the sample already set. The
sample will be highlighted.
• Press the Clone mode button.
• Now press onto the sample buttons you intent to assign the joblist
information for, e.g. sample (02).
• The test/assay information are now copied to the sample (02). Press
again the Clone mode button to deactivate.
Figure 71 Clone Mode
The Clone mode will only copy the test/assay information to another
NOTE
sample. Due to safety reasons sample ID and vial type information
won´t be copied and must be entered manually by sample.
Tools The Tools button in the Load Sample Menu offers several options and
access to other menus and features.
Figure 72 Tools in Load Samples

Operation

Opens the timeline window showing each step
Timeline of the joblist entered in a diagram and provides
run time information.
By pressing this button the current screen will
to the analyser.

Quit
Pressing this button will erase all sample

Erase Jobl.
information (Joblist) of the selected sample.
Show Jobl. Opens and shows the joblist currently entered.
OK
• Pressing the OK button in the Load Sample Menu confirms all changes
in this menu. The following display appears:
Figure 73 Run Preparation Menu
• In the Run Preparation Menu press OK again to return back to the MAIN
MENU. You are now prepared to start the measurements.

Operation
5.2.4 Start Measurements

(Routine & STAT)
• From the Main Menu, press the button Measurement to access the
Measurement Menu.
Figure 74 Menu Measurement
The following window provides information related to the current available

joblist.
The following information is available:
Available information Description
Provides information on the loaded reagents

Reagent Status List and washers, its required volumes, loaded
volumes, stability and lot numbers.
Provides information on the cuvette ring loaded:

- Start Cuvette No.
Cuvettes
- Required cuvettes for the run
- Free cuvettes available on the loaded ring
Provides information on the samples loaded:

- Number of loaded samples
Samples
- Number of samples to be processed
- Number of samples partially processed
Tools The Tools button in the Measurement Menu offers several options and

Operation
Figure 75 Tools in Measurement Menu
By pressing this button the screen will be printed,

Hardcopy
provided a printer is connected to the analyser.
By pressing this button you will leave this window
Quit
without any changes.
Joblist Opens the joblist currently entered.
Opens the timeline window showing each step of

Timeline the joblist entered in a diagram and provides run
time information.
Exit Select Exit to return to the MAIN MENU.
Start the Run Select Start the Run to begin measurement.
• Below message appears. Close the shield of the analyser and confirm
message by pressing the OK button.
Figure 76 Close Shield Message

Operation
The analyser starts preparing the measurement and starts the run if there is
no pending problem. Results and/or related run information are shown in this
window once available.
Figure 77 Running Measurement
STAT The STAT button accesses the Emergency (Load STAT) Menu during a
routine run. This menu command can be used to interrupt the current
measurement in order to load up to 3 emergency samples.
After interrupting the routine run by pressing the STAT button the program
waits until all current measurements have been finished. All routine samples
which have not been worked off will remain in the routine joblist and will be
measured after the STAT tests have been finished.
If you intend to initiate a STAT run by interrupting the routine run now follow
the instructions as provided in the next appearing screens until below
display appears:
Figure 78 Prepare STAT run
The following message appears. If you intend to interrupt the routine run
confirm this message by pressing the Yes button. To continue the routine
run press the No button.
Press the Yes button to initiate a STAT run the following window appears:

Operation
Figure 79 Load STAT Samples
All current running and prepared routine measurements will be finished first.
The window indicates the time until the STAT measurement can be
performed. Once the time counter has ran down the following message
appears:
Figure 80 Warning Message before STAT
Confirm this message and following by pressing the OK button until next
window appears:
Figure 81 Load STAT Samples

Operation
To load STAT samples and start a STAT measurement continue the same
way as described in chapter 5.2.2 Load Reagents 5.2.3 Load Samples
and 5.2.4 Start Measurements.
Status The Status button provides access to an information window, see figure
below.
If there is a general problem the Status button turns orange.

If there is a critical problem the Status button turns red.
If there is no pending problem the Status button turns green.
Figure 82 Status Window
Immediate STOP Press this button to immediately interrupt a current run, in case there are
any pending problems or other reasons. The current run will be stopped by
keeping all pending measurements in the joblist.
• Press the Immediate STOP button and follow the directions as provided
on the display.
Figure 83 Immediate STOP

Operation
Figure 84 Warning user interrupt
After confirming the Warning Message, see figure above the following
window appears providing information of the still pending measurements.
Confirm this message by pressing the OK button, the following window
appears.
Figure 85 Pending Measurements
• Return to the Run Preparation Menu to check/modify the joblist and

repeat the measuring procedure as described. When a run is finished or
interrupted the Results of last run list appears:
Figure 86 Short Form Results

Operation
The following procedure is performed after a run is finished.
Print
• Press the Print button to print the short form result list.
OK
• Press the OK button to leave this window.
Tools The Tools button in the Running Measurement screen offers several
options and access to other menus and features.
Figure 87 Tools in Running Measurement Screen
By pressing this button you enter into the result

Results
list.
By pressing this button you will interrupt the run

Interrupt after the current measurements have been
finished.
By pressing this button you will print the screen,

Print

Quit
By pressing this button you will see the reaction

R-Curve
curve graph of the current run in real time.

Timeline
of the joblist entered in a diagram.

Operation
5.2.5 Show/print results

• From the Main Menu, press the Results/Run button to access the short
form result list.
Figure 88 Results/Run
This window displays all results of the last run sorted by sample. In case of
any measuring problem the results involved will be highlighted in orange
colour indicating the failure occurred.
The following failure codes are available:
Error Flags Description
The measurement has been finished with no

State: OK
problems.
Deviation Error:
State: D The specified mean value deviation set in the
test setup is exceeded.
Temperature Error:
State: T Temperature problems occurred at pipettor or
rotor
Mixer Error:
State: M
The mixer motor(s) do not properly work.
Reagent Mixer Error:

State: S The reagent mixer motor does not properly
work.
Photometer Error:
Sate F: A photometer error was detected during the
measurement.
Liquid Error:
State: L Not enough reagent or sample available during
the run.

Operation
Print To print the short form result list press the Print button. Make sure a printer
is connected to the analyser, prior starting a print-out, see chapter 4.3.4
Connecting an external printer.
OK Press the OK button to return to MAIN MENU.
5.2.6 Results Memory

• From the Main Menu, press the button Results/Memory to access the
result memory of the analyser.
Figure 89 Results/Memory 1
• From the Main Menu, press the button Results/Memory to access the
result memory of the analyser.
The internal analyzer memory keeps a maximum of 100 results in memory.

Once the memory contains 100 results the next following results measured
will delete automatically the oldest result in the ring storage.
The following result selection is available:
Result Selection Description
Displays all results available in chronologic

All
order.
Sample Displays the results sorted by sample/patient.
Test Displays the results sorted by test/assay.

Operation
5.2.6.1 Show/print reaction curves

In the ring result storage you may show and print the reaction curves of the
results available. Up to six reaction curves may be displayed in the same
diagram.
Figure 90 Results/Memory 2
• From the Results/Memory window select an input field visible at the

bottom of this window (only available if USB Stick is attached to system).
Figure 91 Curve Input
• Press into an input field to open the keyboard entry. The following
window appears.
Figure 92 Curve Input keyboard
• Enter the Result No. as shown on the left side of the results ring storage
list, example 23 using the numerical keypad. Confirm by pressing the
Enter button.
• Follow the same procedure to select more reaction curves to display.
• When all result nos. are entered press the Tools button in the result ring
storage window.

Operation
Tools The Tools button in the ring result ring storage offers several options and
Figure 93 Tools in Results/Memory

By pressing this button selected results will be
Print printed including all result data and curve
information.

Quit
Hardcopy Performs a print of the screen only.
Opens the curve diagram window to show the

Graph
reaction curves selected.
• Press the Graph button in the Tools window to display the selected
reaction curves.
Figure 94 Reaction Curves

Operation
Tools The Tools button in the reaction curve diagram window offers additional
Figure 95 Tools in Reaction Curve Diagram

Increases the scale of the displayed curve. By
Zoom IN pressing into the curve screen and holding you
may move the curve into all directions.
Reduces the scale of the displayed curve. Only

Zoom OUT
available after using Zoom IN first
Resets the scale of the curve diagram to the

Zoom RESET
initial setting.

Quit
OK Press the OK button to leave this menu.

Operation
5.2.7 Analyser Status

At any time the analyser offers information on the current status of the
system.
• From the Main Menu, press the button Status to access the Status
Menu.
Figure 96 Status Menu
The Status Menu provides information on the current state of container level
sensors, occurred measuring failures, still available cuvettes of the cuvette
ring, cuvette ring credits available, temperature of the measuring rotor and
pipettor as well as state of motors and displays any irregularities and errors
which may appear during a run.
• Additionally this status information can be printed by pressing the Print

button.
• Leave this menu by pressing the OK button.

Operation
5.3 Setup Menu
The Setup Menu allows you to Setup all operational analyser, test and
reagent parameters either manually or loading the same using an USB-
Stick. Certain areas within the Setup Menu may only be accessed by
entering a PIN Code in the Main Menu. The software indicates the level of
password required accessing into another level.
Menu Button Function Software Level
Passwords To set passwords to access different software level. Expert
Reagent Setup To define and edit reagent specific parameters Anyone
Date & Time To edit analyser date & time. Anyone
Im/Export To im/export test & reagent parameters via USB Stick. Anyone
Initiates an automatic self test procedure of the
Selftest Anyone
analyser.
To define and edit test specific parameters. To
Test Setup Anyone
combine individual reagents.
Perform calibration and management of calibration
Calibration Anyone
data, curves.
Delete Results To delete all results of the ring memory Expert
To import other languages via USB Stick, reset
Language Anyone
language to factory default.
Check Box to activate/deactivate automated print of
STAT Autoprint Anyone
STAT parameters
Select Box to select whether the working mode of a
Working Modes Anyone
measurement shall be done by sample or by test
Check Box to activate/deactivate acoustic signals
Beeper Anyone
performed by the anlyser.
Headline Defines print headline Anyone
Tools Access to other functions Anyone
OK Return to MAIN MENU Anyone

Operation
5.3.1 Im/Export test & reagent

parameter via USB-Stick
This chapter describes how to Import and Export test and reagent specific
parameters by using a USB-Stick.
5.3.1.1 Mounting an USB-Stick

Prior using a USB-Stick to import or export test and reagent parameters it is
necessary to introduce (mount) the USB device to the analyser software
first. If not already attached to the system the following description explains
how to mount a USB-Stick.
• From the Main Menu, press the button Shutdown the following display
appears.
Figure 98 Stop System
• By pressing the button Switch Off the software allows you to switch off
the power switch located at the back side of the analyser. Switch off
analyser by setting power switch to position O = OFF.
• After switching off the analyser attach the USB-Stick to the USB
interface located at the right side of the analyser within the carrying
handle, see Figure 37 USB-Stick Interface.
• Re-start the analyser again by setting the power switch to position I =

ON and follow the initialization sequence of the analyser. The USB-Stick
has now been mounted by the system software.
5.3.1.2 Import data from USB-Stick

Once an USB-Stick is mounted by the system software parameters can be
imported from an USB-Stick.
• From the Main Menu, press into the window underneath Password/PIN
to enter a PIN Code.
• A numerical keypad opens allowing entry of the Pin Code level. Enter
the PIN Code 12345 to allow access to the expert level of the software
and confirm with ENTER.

Operation
• From the Main Menu, press the button Setup to access the Setup
Menu.
• From the Setup Menu, press the button Im/Export Test&Reagent

Parameters via USB-Stick.
Figure 99 Im/Export Test & Reagent Parameters
The following Features are available:

Quit
By pressing this button you will start the export

Export sequence to load data from the analyser to the
USB-Stick.
By pressing this button you will start the import
Import sequence to load data from the USB-Stick to the
analyser.
• Press the button Import to load test and reagent parameters from the
USB-Stick to the analyser.
Figure 100 Import Test & Reagent Parameters

Operation
By importing test and reagent parameters to the analyser all current

NOTE available parameters on the analyser will be overwritten. Export
such data first to the USB-Stick in case you want to safe these
current system parameters, see chapter 5.3.1.3 Export data to USB-
Stick.
• Press Yes to start the import sequence. By pressing No you will leave
this window. While importing the parameters the following window
appears.
Figure 101 Importing Parameters
Figure 102 Parameter Import OK
• Once the import sequence is finished confirm by pressing the OK

button. The parameters have successfully being brought to the analyser.
• Back in the Setup Menu press the OK button to get back to the Main
Menu.
• Shutdown the system, refer to chapter 5.3.1.1 Mounting an USB-Stick

and remove the USB-Stick carrying the test and reagent parameters.
You may now attach another USB-Stick used to record results data.

Operation
5.3.1.3 Export data to USB-Stick

To transfer test and reagent parameters to an USB-Stick you may proceed
the same way as described in the chapters before. Make sure an USB-Stick
is mounted by the system software, see chapter 5.3.1.1 Mounting an USB-
Stick prior you start exporting parameters.
• From the Main Menu, press into the window underneath Password/PIN
to enter a PIN Code.
• A numerical keypad opens allowing entry of the Pin Code level. Enter
the PIN Code 12345 to allow access to the expert level of the software
and confirm with ENTER.
Menu.
• From the Setup Menu, press the button Im/Export Test&Reagent

Parameters via USB-Stick.
Figure 103 Im/Export Test & Reagent Parameters
The following Features are available:

Quit
By pressing this button you will start the export

Export sequence to load data from the analyser to the
USB-Stick.
By pressing this button you will start the import
Import sequence to load data from the USB-Stick to the
analyser.
• Press the button Export to transfer test and reagent parameters from
the analyser to the USB-Stick.

Operation
Figure 104 Export Test & Reagent Parameters
Figure 105 Remove USB-Stick
• Once the export sequence is finished confirm above message by

pressing either Yes to remove the USB-Stick or No if you intent to leave
the USB-Stick mounted to the analyser. By pressing Yes the following
window appears.
Figure 106 Mounting another USB-Stick

Operation
• You may decide whether a new USB-Stick, for example to safe result
data shall be mounted or the current USB-Stick shall remain mounted.
Press Yes to mount another USB-Stick after you have replaced the USB
Sticks.
• By pressing the OK button you get back to the Main Menu.
5.3.2 Select Working Modes
In the Setup Menu you may further select whether the working mode shall
be done by sample or by test.
By pressing the corresponding radio button you select the desired working
mode.
By sample = All tests/reagents assigned to a sample/patient will be

measured patient oriented, sample by sample.
By test = All tests/reagents assigned to a sample/patient will be

measured test oriented, test by test.
• Press the radio button in the Working Modes frame to select the
desired measuring sequence.
Figure 107 Setup Working Modes

Operation
5.3.3 Setup Reagent definition

This chapter describes how define a new reagent or modify existing reagent
data.
• From the Main Menu, press the Setup button to access the Setup Menu.
• From the Setup Menu, press the Reagent Setup button to access the
Select Reagent Screen.
Figure 108 Select Reagent Screen
The Select Reagent Screen contains a list of all reagents saved, including
buffers and diluents.
The list contains up to 50 reagent definitions available. Free reagent

definition files can be programmed by the user.
1) To display or modify the data of a reagent use the arrow keys to first
select the reagent and then press the OK button to continue.
2) To define a new reagent use the arrow key and move upward until a free
position appears and also press the OK button to continue.
The following example provides description on how to program a PT

reagent. Proceed the same way if you intent to enter new reagent data or to
modify existing reagents.
• In the Select Reagent Screen chose PT and confirm by pressing the OK

button.

Operation
Figure 109 Edit Reagent Main Screen
Name
By pressing into the Name input field a keypad opens allowing the entry or
modification of the name of a reagent. The reagent name may have up to 15
alphanumerical characters.
Abbrev.
By pressing into the Abbrev. (abbreviation) input field a keypad opens
allowing the entry or modification of the abbreviation of a reagent name. The
reagent abbreviation may have up to 5 alphanumerical characters. This
abbreviation is used in other menu screens for identification of the reagent.
Parameters
The parameter frame allows access to other sections required to define or
modify a reagent.
5.3.3.1 Parameter Page 1

By pressing the Page 1 button the following window opens:
Figure 110 Edit Reagent Page 1
Within this screen the following general reagent data can be defined or
modified:

Operation
Lot No. By pressing into the Lot-No. input field a keypad opens allowing the entry
or modification of the lot number of a reagent. The lot number may have up
to 15 alphanumerical characters.
If you enter a new lot number and leave the keypad window, all tests
NOTE
using this reagent must be recalibrated.
Stability By pressing into the Stability input field a keypad opens allowing the entry
or modification of the stability time of a reagent. The stability time may have
up to 5 numerical characters. Input range: 1 - 99 (h).
Vial By using the select box arrows you may define or modify the vial size of the
reagent bottle used.
The following vial sizes are available:
Reagent positions Selectable vial sizes
15ml Glass
12ml Glass
R1 - R3
5ml Glass
4ml Plastic
5ml Glass
R4 - R15 4ml Plastic
Cup
Calibrate By using this check box button you may define or modify whether the
reagent requires calibration, see chapter 5.3.5 Calibration. Set individual
parameters On/Off by pressing onto the coloured field, e.g. OFF= light blue,
ON = dark blue.
Once a reagent is set to calibrate all tests using this reagent must be
NOTE
calibrated, e.g. when changing the reagent lot. Test having an
invalid calibration may not be used for a run.
Stirring Parameters This parameter frame allows definition of stirring parameters used for reagents
which require stirring due to the risk of sedimentation of particles. Such
reagents must be placed in the reagent area either on position R1 and/or R3,
see chapter 3.1.2 Working Plate. The following settings are available:
Stirred By pressing into the Stirred input field a keypad opens allowing the entry or
modification of the stirrer rpm (revolutions per minute). 0=off indicates the
reagent does not require stirring. Input range: 0 - 500 (rpm).
Cycle time By pressing into the Cycle time input field a keypad opens allowing the
entry or modification of the total duration (interval) of the stirring cycle in
seconds. After a stirring interval ended a new interval will be started.
Input range: 0, 10 - 500 (sec.).
Cycle Pause By pressing into the Cycle pause input field a keypad opens allowing the
entry or modification of the duration of the pause time until a new cycle time
starts again. Input range: 0 - 499 (sec.). Input must be 5 sec. less the
entered Cycle time, e.g. Cycle time = 200, entry range at Cycle Pause =
0…195 sec.

Operation
The difference between Cycle time and Cycle Pause results to the
NOTE
actual stirring time, e.g. Cycle time = 60 sec. and Cycle Pause = 40
sec. the actual stirring time is 20 sec. (60s-40s).
Tools The Tools button in the Edit Reagent No.1 Page 1 window offers additional
Figure 111 Tools in Edit Reagent Page 1

Quit
OK Press the OK button to return back to the Edit Reagent Main Screen.
Figure 112 Edit Reagent Main Screen

Operation
5.3.3.2 Parameter Page 2

To enter further parameters in this section continue by pressing the Page 2
button allowing entry or modification of the following parameters:
Figure 113 Edit Reagent Page 2
Aspiration By pressing the Select Box arrow buttons you may select between 4
predefined liquid aspiration profiles. These profiles contain parameters
related to the speed the liquids will be aspirated by the probe of the
analyser.
The following aspiration profiles are available:
Available profiles Description
max_speed: 6500 ms
Profile 1 (Default) ramp_speed: 250 ms
ramp_break: 100 ms
max_speed: 4000 ms
Profile 2 ramp_speed: 200 ms
ramp_break: 60 ms
max_speed: 4000 ms
ramp_break: 35 ms
max_speed: 5000 ms
ramp_break: 30 ms
The manufacturer recommends leaving the profiles always set to

default. Before changing the profiles consult your local dealer or the
NOTE
manufacturer!

Operation
Dispensing By pressing the Select Box arrow buttons you may select between 4
predefined liquid dispensing profiles. These profiles contain parameters
related to the speed the liquids will be distributed by the probe of the
analyser.
The following dispensing profiles are available:
Available profiles Description
max_speed: 6500 ms
Profile 1 (Default) ramp_speed: 250 ms
ramp_break: 100 ms
max_speed: 4000 ms
ramp_break: 60 ms
max_speed: 4000 ms
ramp_break: 35 ms
max_speed: 5000 ms
ramp_break: 30 ms
The manufacturer recommends leaving the profiles always set to

default. Before changing the profiles consult your local dealer or the
NOTE
manufacturer!
Washing By pressing the Select Box arrow buttons you may select between 5
predefined washing profiles. These profiles contain parameters related to
the rinse and wash duration times and volumes of liquids required.
Type Cycle description
Normal System water, 1 sec. rinsing
Washer 1 (Pos. W1)

Washer 2 (Pos. W2)
Washer 1 (Pos. W1)
Intensive 4 4 sec. rinsing with system water.

Operation
Waste Vol. By pressing into the Waste vol. input field a keypad opens allowing the
entry or modification of the waste volume in µl. The waste volume is taken in
addition to the dispensing volume in order to obtain a better pipetting
accuracy and will be discarded later in the rinsing station. Default = 5µl.
Input range: 1 - 20 (µl).
Tests, Reagent/Buffer is
assigned to This window provides information on the tests to which a reagent/buffer as
edited or modified in this section is assigned to.
Tools The Tools button in the Edit Reagent No.1 Page 2 window offers additional
Figure 114 Tools in Edit Reagent Page 2

Quit
OK Press the OK button to return back to the Edit Reagent Main Screen.

Operation
Tools
Tools button in the Edit Reagent Main Screen offer several options and
Figure 115 Tools in Edit Reagents Main Screen
By pressing this button the selected reagent will

be fully deleted from the reagent list. Reagents
Delete
assigned to certain tests require the test to be
deleted first.
By pressing this button the selected reagent
may be copied and saved with the same
Save as
parameters as another reagent in the reagent
list.

Quit
By pressing this button the reagent parameters

Print will be printed via the external connected
printer.
By pressing this button the edit reagent screen

Hardcopy will be printed, provided a printer is connected
to the analyser.
Undo&Exit By pressing the Undo&Exit button you will leave the Edit Reagent Menu
without saving the previous done changes and modifications.
Save&Exit Pressing the Save&Exit button in the Edit Reagent Menu confirms all
changes and modifications done in this menu and starts level check of all
reagents and washers on board.

Operation
5.3.4 Setup Test Definition

This chapter describes how to define a new test or to modify an existing test.
• From the Main Menu, press the Setup button to access the Setup Menu.
• From the Setup Menu, press the Test button to access the Select Test
Screen.
Figure 116 Select Test Screen
The Select Test Screen contains a list of all tests saved. A total of 50 tests
can be saved. Free test definition files can be programmed by the user.
1) To display or modify the data of a test use the arrow keys to first select
the test and then press the OK button to continue.
2) To define a new test use the arrow keys and move upward until a free
position appears and also press the OK button to continue.
The following example provides description on how to program a PT test.

Proceed the same way if you intent to enter new test data or to modify
existing test.
• In the Select Test Screen chose PT and confirm by pressing the OK

button.

Operation
Figure 117 Test Menu Main Page
Name
By pressing into the Name input field a keypad opens allowing the entry or
modification of the test name. The test name may have up to 15
alphanumerical characters.
Abbrev.
By pressing into the Abbreviation (abbrev.) input field a keypad opens
allowing the entry or modification of the abbreviation to be assigned to a
test. The test abbreviation may have up to 5 alphanumerical characters.
This abbreviation is used in other menu screens for identification of the test.
Parameters
The parameter frame allows access to other sections required to define or
modify a test. The following sections are available:
The following Parameters are available:
Parameters Description
To define all liquid related parameters, such as:
- Sample Volume
Liquids - Buffer/Diluent dilution
- Reagent Volumes
- Incubation times
To define evaluation and calculation modes, such as:

- 1st Evaluation
Evaluation - 2nd Evaluation
- Wavelength setting
- Max. Measuring Time
To define additional test parameters, such as:

- No of determination
Determin.
- Max. Deviation & Lag Phase
(Determination)
- Mixing parameters
- Raw Value Parameters
To define the parameters to be displayed or printed in

Show flags
the short from result list.

Operation
5.3.4.1 Liquids
From the Test Menu Main Screen press the Liquids button to display or
modify liquid related parameters for a test, like sample and reagent volumes.
Figure 118 Test Menu Liquids
Sample By pressing into the Sample input field a numerical keypad opens allowing
the entry or modification of the total Sample Volume in µl. For diluted
samples (undiluted sample + buffer) or for undiluted samples, this
corresponds to the required Sample Volume. Input range: 2.0 - 250.0 (µl).
Sample Start By using this check box button you may define or modify whether the
measurement will be started either with Sample or Reagent. Set individual
parameters On/Off by pressing onto the coloured field, e.g. OFF= light blue
(Reagent-Start), ON = dark blue.
Buffer/Diluent By pressing into the Buffer/Diluent input field a numerical keypad opens
allowing the entry or modification of the Dilution Value. After entering a
Dilution Value > 0µl (0= no dilution) a selection window appears allowing
you to select a Buffer/Diluent. Input range: 0.0 - 49.0 (at 100µl Sample Vol.).
• Enter the Dilution Value

• Select the Buffer/Diluent
Example: 50µl Sample Volume total

Pipetting: 2µl Sample + 48µl Buffer/Diluent
Entry: 1+24
The range depends on the total Sample Volume, whereas the minimum
pipetting volume is 2µl.
Incubation time By pressing into the Incubation (incubat.) input field a numerical keypad
opens allowing the entry or modification of the Incubation Time in sec.
Input range: 0.0 - 999.0 (sec.).
Reagent 1 + 2 Up to 2 additional reagents can be selected from the Select Reagent List. By
pressing into the Reagent 1 + 2 input fields a numerical keypad opens
allowing the entry or modification of the Reagent 1 + 2 volume in µl. After
entering a Reagent Volume > 0µl (0= no reagent) a selection window
appears allowing you to select a reagent and to define additional incubation
times for each reagent selected. Input range: 0.0, 2.0 - 250.0 (µl).

Operation
• Enter the Reagent Volume

• Select the reagent
• Enter Incubation Times for reagent 1+2
The reagents will be added to the cuvette in order listed.
Start Reagent By pressing into the Start Reagent input field a numerical keypad opens
allowing the entry or modification of the Start Reagent volume in µl. After
entering a Start Reagent volume > 0µl (0= no reagent) a selection window
appears allowing you to select a Start Reagent. Input range: 0.0, 2.0 - 250.0
(µl).
• Enter the Start Reagent volume

• Select the Start Reagent
NOTE The total volume in the cuvette must be between 150µl and 300µl.
Tools The Tools button in the Test Menu Liquids Screen offers additional options
and access to other menus and features.
Figure 119 Tools in Test Menu Liquids

Quit
OK Press the OK button to return back to the Test Menu Main Screen.

Operation
5.3.4.2 Evaluation
From the Test Menu Main Screen press the Evaluation button to display or
modify evaluation mode parameters for a test. The following display
appears:
Figure 120 Test Menu Evaluation
1st Evaluation By pressing the Select Box arrow buttons you may assign clotting detection
with seconds as raw values. This evaluation mode is used to analyze the
measuring signal (= reaction curve) to be applied for test using a first
evaluation.
The following selection is available:
Available methods Description

Sets the evaluation method to clotting and
allows entry of additional parameters by using
the Tech button.
Clotting (sec.) Calibration parameters for this test can only be
entered if clotting is selected, see chapter
5.3.5.1 Edit Calibration for Clotting (manual
calibration).
No evaluation method is set. No calibration
off parameters can be assigned to tests using 1st
evaluation.
After setting the evaluation method to clotting [sec.] an additional button

Tech appears allowing the entry of additional parameters.
• Press the Tech button.

Operation
Figure 121 Test Menu Tech Clotting
Valid Clotting By pressing into the Valid Clotting input fields a numerical keypad opens
allowing the entry or modification of the min. /max. Valid Clotting Range in
sec. The Valid Clotting Range defines the range within a measured clotting
time will be detected and the range of raw values which may be entered as
calibration values, refer to chapter 5.3.5.1 Edit Calibration for Clotting
(manual calibration). Measured clotting times or calibration points outside
this range will be marked with an error flag “none”.
Valid Clotting Input Ranges and dependency

Times
Input range: 1 - 3.600 (sec.)
Min. Valid Lowest value: >/= Lag Phase
Clotting >/= Learn Phase
Highest value: < max. Valid Clotting
Input range: up to 3.600 (sec.)

Max. Valid Lowest value: > min. Valid Clotting
Clotting Highest value: </= Measuring time (auto repeat off)
Highest value </= 2x Measuring time (auto repeat on)
Auto-repeat By using this check box button you may define or modify whether the
measurement will be repeated automatically if a measurement can not be
detected in the first run, e.g. if the max. measuring time has been passed
over and no clotting could be found. Set individual parameters On/Off by
pressing onto the coloured field, e.g. OFF= light blue (No Auto-repeat), ON =
dark blue (activated Auto-repeat).
By setting this button a measurement without clot detection will be

automatically repeated after the initial run has been finished. These
measurements will be repeated with the double measuring time, see chapter
5.3.4.2 Evaluation / Measuring Time.
NOTE It is mandatory to set the max. valid clotting time to 2x the set
measuring time if auto repeat is active otherwise the clotting times
found outside the valid clotting time will not be calculated and the
result would be shown as “none”.

Operation
Example: Measuring Time = 30 sec.

There is no result detected within the 30 sec. Run will be
repeated automatically with a Measuring Time of 60 sec. Max.
valid clotting time must be set to max. 60sec.
Learn Phase By pressing into the Learn Phase input field a numerical keypad opens
allowing the entry or modification of the learn phase in sec. The Learn
Phase defines the time range of the threshold width used for the clotting
evaluation.
The defined learn phase time is also depending on the Lag phase setting,
see section Determin. The learn phase may not be higher than the entered
min. Valid Clotting time.
Input range: 1 - 60 (sec.).
Example:
Lag Phase = 8 sec.
Learn Phase = 1 sec.
That means: Lag Phase (8) - Learn Phase (1) = 7 seconds after start of a
measurement the evaluation for the clotting detection begins. Whereas the
min. Valid Clotting Time may not be lower than 8 sec. because during the
Learn Phase the thresholds for clot detection are adjusted by the software.
Algorithm of clot By pressing the Select Box arrow you may select out of 12 predefined
detection evaluation algorithms having different influence on the clotting detection.
Once selected a short description will be provided below the Select Box
window.
The manufacturer recommends leaving the algorithm as set to

default. Before changing the algorithm consult your local dealer or
NOTE
the manufacturer!
Scaling By pressing into the Scaling input field a numerical keypad opens allowing
the entry or modification of the Scaling Factor. The Scaling Factor is used to
adjust the photometrical measuring value as a multiplier for the extinction
values respectively the transmission values or digits depending on the
parameterized raw values. Input range: 0.1 - 99999. Default = 20.
Tools The Tools button in the Tech Clotting Screen offers additional options and

Quit
OK Press the OK button to return back to the Test Menu Evaluation Screen.

Operation
Figure 122 Test Menu Evaluation/Kinetic
2nd Evaluation By pressing the Select Box arrow buttons you may select between 3
predefined evaluation modes. These methods are used to analyze the
measuring signal (= reaction curve) to be applied for tests using a second
evaluation.
The following selection is available:
Available modes Description
No evaluation method is set. No calibration

Off parameters can be assigned to tests using
2ndevaluation.
Sets the evaluation method to Kinetic and

Kinetic [mE/min] the Tech button.
Calibration parameters for this test can be
entered if kinetic is selected, see chapter 5.3.5.2
Sets the evaluation method to Difference and

the Tech button.
Difference [mE]
entered if difference is selected, see chapter
5.3.5.2
Sets the evaluation method to 1st Deviation and

the Tech button.
1st deviation [mE/s]
entered if 1st deviation is selected, see chapter
5.3.5.2
After setting the evaluation method to Kinetic [mE/min], Difference [mE] or

1st deviation [mE/s] an additional button Tech appears allowing the entry
of additional parameters.
• Press the Tech button and the following window appears.

Operation
Figure 123 Test Menu Tech Kinetic
Evaluation Points By pressing into the Evaluation Points input fields numerical keypads
open allowing the entry or modification of the T1/T2 Evaluation Points in sec.
Evaluation Points Input Ranges
Input range: 1 - 3.600 (sec.)

T1 Lowest value: Lag Phase + 1 sec.
Highest value: T2 - 1sec.
Input range: up to 3.600 (sec.)

T2 Lowest value: T1 + 1sec.
Highest value: Measuring time - 2 sec.
The settings of the T1/T2 Evaluation Points have different effects on the
evaluation method selected:
Selection Description
The evaluation of the slope takes place in the

Kinetic [mE/min] defined time range between T1 and T2.
The evaluation of the extinction difference takes

place by means of measuring values Ext. [T2] -
Ext. [T1] if rising is set active.
Difference [mE]
The evaluation of the extinction difference takes
place by means of measuring values Ext. [T1] -
Ext. [T2] if rising is set inactive.
The evaluation of the maximum slope [mE/sec.]

1st deviation [mE/s] and the time [sec.] takes place in the time range
up from T1 and until T2.
Rising Values By using this check box button you may define or modify whether the
expected raw values of the measuring results are rising or falling. Set
individual parameters On/Off by pressing onto the coloured field, e.g. OFF=
light blue (falling values), ON = dark blue (rising values).

Operation
Correlation Coefficient By pressing into the Correlation Coefficient input field a numerical keypad
opens allowing the entry or modification of the Correlation Coefficient used
for the evaluation of the linearity of a calibration curve.
Input range: 0 - 1,000.
Assuming the measured values between T1 and T2 rise or fall

approximately linear the slope is calculated by linear regression over all
measurements between T1 and T2. This is the searched raw result in
mE/min. In addition, the correlation coefficient is calculated. Is this
coefficient close to 1, the measured values corresponding well to this line, if
close to 0 they doing not - e.g. because the values are extremely noisy, or
because the curve has too much curvature. Therefore a limit on the
correlation coefficients is set in order to decide whether a curve can be
evaluated or not.
This parameter is only for a Kinetic evaluation method.
Tools The Tools button in the Tech Kinetic Screen offers additional options and

Quit
OK Press the OK button to return back to the Test Menu Evaluation Screen.
Figure 124 Test Menu Evaluation/Kinetic
Wavelength By pressing the Select Box arrow buttons you can select between the
available wavelengths depending on the test requirements.
Depending on the analyser model the following wavelength are available:
• 405 nm (only for analyzers equipped with 1wavelenght)

• 570 nm
• 740 nm

Operation
Measuring Time By pressing into the Measuring Time input field a numerical keypad opens
allowing the entry or modification of the Measuring Time in sec. The reaction
curve is evaluated between the end of the lag phase and this time
(Measuring Time). Input range: 20 - 3.600 (sec.).
Tools The Tools button in the Test Menu Evaluation Screen offers additional

Quit
Figure 125 Test Menu Main Page
5.3.4.3 Determination
From the Test Menu Main Screen press the Determin. button to display or
modify test related parameters, like no. of determination, mixing and raw
value parameters. The following display appears:
Figure 126 Test Menu Determin.

Operation
No. of Determination By pressing into the No. of Determination input field a numerical keypad
opens allowing the entry or modification of the number of determination
(single or multiple) assigned to a test.
Input range: 1 - 32 (Default = 1).
Is the number of determination set to multiple, meaning > 1 the maximum

deviation must be defined to specify to what extent each single value may
deviate, see Max. Deviation.
Max. Deviation By pressing into the Max. Deviation (CV) input field a numerical keypad
opens allowing the entry or modification of the maximum deviation in %. The
maximum deviation indicates the permitted deviation of the measured values
for multiple determinations. This field only appears if the No. of
Determination is set to > 1. Input range: 0 - 20 (%); 0=off.
Once the single values are outside of this range the single values will be
marked by the software.
Lag Phase By pressing into the Lag Phase input field a numerical keypad opens
allowing the entry or modification of the Lag Phase in sec. The reaction
curve is evaluated after the end of this time (after start of measurement) and
the defined measuring time. Input range: 0 - 60 (sec.).
Mixing rpm 1 By pressing into the rpm1 input field a numerical keypad opens allowing
the entry or modification of the mixer (stirrer) start speed at start of
measurement. Input range: 0, 200 - 999 (rpm).
Mixing rpm 2 By pressing into the rpm2 input field a numerical keypad opens allowing
the entry or modification of the mixer (stirrer) end speed after termination of
the mixing time (mixing ramp). Input range: 0, 200-999 (rpm).
Example: rpm1 = 500; rpm 2 = 800, ramp = 5 sec.

The measurement will start with 500 rpm mixer revolutions. The final
revolutions of 800 rpm will be reached after 5 seconds until the end of the
entered measuring time.
Mixing ramp By pressing into the ramp input field a numerical keypad opens allowing
the entry or modification of the time until rpm2 starts. Input range: 2-300
(sec.).
Raw Value Parameters The Raw Value Parameter section allows parameterization of the raw value
settings used for the evaluation algorithm to calculate the measuring result.
Additionally the raw value ranges within the raw values will be calculated
can be defined.
Raw Values By pressing the Select Box arrow buttons you can select between 4
available evaluation algorithms.
The following evaluation algorithms are available:
Available algorithms Description

Sets the evaluation algorithm to Extinction, raw
Extinction [mE]
values will be calculated in [mE].
Sets the evaluation algorithm to 1st Deviation,
1st deviation [mE/s]
raw values will be calculated in [mE/s].
Sets the evaluation algorithm to Digits, raw
Digits
values will be calculated in digits.
Sets the evaluation algorithm to Transmission,
Transmission [%]
raw values will be calculated in [%].

Operation
Valid By pressing into the Valid input field numerical keypads open allowing the
entry or modification of the range within the raw values will be evaluated.
Raw values outside this range will be marked. Input range: see below table.
Evaluation algorithm Input Ranges
Extinction [mE] - 500 - + 3200
- 200 - + 200
Exception: To evaluate this algorithm, 1st
1st deviation [mE/s] deviation must be set under Raw Value as well
as in the Evaluation section as 2nd Evaluation,
see chapter 5.3.4.2 Evaluation
Digits 0 - + 8388607
Transmission [%] - 50 - + 150
Smoothing The Smoothing button allows you to select between a numbers of digital
filters available to even (smooth) the measuring signals.
• Press the Smoothing button and the following window appears.
Figure 127 Test Menu Misc. Smoothing
The Select type of digital lowpass screen contains a list of digital filter
settings available. To select a digital filter for a test use the arrow keys to
first select the filter and then press the OK button to continue. By pressing
the ESC button you will leave this screen without any selection.
It is recommended to consult your local dealer or the manufacturer

NOTE
first before changing the digital filter setting!
Tools The Tools button in the Test Menu Miscellaneous Screen offers additional

Operation

Quit
5.3.4.4 Define Results/Run list

Within this section you may define the contents to be shown in the Results
per run list, see chapter 5.2.5 Show/print results.
From the Test Menu Main Screen press the Show-Flags button to display or
modify the contents of the short form result list.
Figure 128 Test Menu Show-Flags
Set flags By using the check box buttons you may define or modify the results
separated by evaluation mode to be displayed and or printed within the
results per run list.
Set individual parameters On/Off by pressing onto the coloured field, e.g.
OFF= light blue (inactive), ON = dark blue (active).
Tools The Tools button in the Test Menu Show-Flags Screen offers additional

Quit

Operation
Tools
Tools button in the Test Menu Main Screen offer several options and
Figure 129 Tools in Test Menu Main Page

By pressing this button the selected test will be
Delete fully deleted from the test list. Reagents assigned
to certain tests require the test to be deleted first.
By pressing this button the selected test may be
Save as copied and saved with the same parameters as
another test in the test list.
Quit
By pressing this button the test parameters will be
Print
printed via the external connected printer.
By pressing this button the Test Menu Main
Hardcopy screen will be printed, provided a printer is
connected to the analyser.
Undo&Exit By pressing the Undo&Exit button you will leave the Test Menu without
saving the previous done changes and modifications.
Save&Exit Pressing the Save&Exit button in the Test Menu confirms all changes and
modifications done in this menu. Prior of acceptance the software will check
conformity on all edited parameters. In case of any invalid inputs the
software will indicate the corrections required.

Operation
5.3.5 Calibration
Use this menu to calibrate a test manually or by automated calibration, to
define or change the calibration parameters for a test. A calibration is
required for test to which the raw values need to be converted into
concentration units/activities.
The test must/can be calibrated if:
• If the evaluation mode for 1st and 2nd evaluation is not set to OFF, refer
to chapter 5.3.4.2 Evaluation.
• A Lot Number was added or changed in a reagent set to calibrate, see

chapter 5.3.3.1 Parameter Page 1.
• If reagent parameters are changed using a reagent set to calibrate, see

chapter 5.3.3.1 Parameter Page 1.
A calibration is not possible if reagents are not set to calibrate, see

NOTE
section Reagent Setup/Page 1/Calibrate (check box) in chapter
5.3.3.1 Parameter Page 1.
Menu.
• From the Setup Menu, press the button Calibration to access the
Calibration Menu.

Operation
Figure 131 Select test Calibration
The Select Test Screen for calibration contains a list of all tests available.
• Select a test for calibration by using the arrow keys first to select the test
and then press the OK button to continue.
The calibration for test screen appears.
Figure 132 Calibration Menu Main Page
General Settings The analyzer offers two different ways to calibrate a test.
- Under Edit Calibration a test can be calibrated manually by editing the

calibration data previously measured. Enter manually the evaluated
results achieved by a normal measurement with dilutions or if available
with standard plasmas or those which have been provided in the
package inserts of the reagent supplier used.
- Under Auto Calibration a test will be automatically diluted from a

standard and the measured calibration data will be automatically added
into a calibration curve and memorized for the test.
The following chapters will describe how to enter or change parameters for
each way of calibration:

Operation
Chose mode of calibration By pressing the Select Box arrow button you can select between 2 available
calibration modes. The different modes define how the raw value of a
calibration curve are converted and further allows entry of calibration
parameters for tests requiring 2 different calibration curves, for example
derived Fibrinogen.
The following calibration modes are available:
Calibration modes Description
Converts raw values [sec.] into a defined

Clotting
unit/activity.
Kinetic: Converts raw value [mE/min.] into a

defined unit/activity.
Kinetic / Difference / Difference: Converts raw value [delta mE] into a

1st deviation defined unit/activity.
1st devi.: Converts raw value [mE/sec.] into a

Before selecting the calibration mode in this screen the

NOTE corresponding evaluation mode must be assigned to the test first,
see chapter 5.3.4.2 Evaluation to assign the 1st and or 2nd
evaluation to a test also defining whether the test allows entry of 2
calibration curve parameters.
5.3.5.1 Edit Calibration for Clotting

(manual calibration)
• Select Clotting by using the arrow keys to enter calibration parameters

for tests based on clotting or to define parameters for a test using 1st
evaluation.
Calculation Press the Calculation button in Edit Calibration to access the Calibration
Menu for Clotting, the following window appears. Contents of the boxes that
appear on the screen vary depending on the units selected in the test.
Figure 133 Calibration Menu Clotting

Operation
1st conversion By pressing the Select Box arrow button you can select between 2 available
conversion modes to define the 1st conversion.
The following 1st conversion modes are available:
Conversion modes Description

No conversion of raw values, results will be shown
in seconds only. By selecting none, no further
None
entries on this page are required. No calibration
curve is measured
Allows conversion of raw values into
units/activities. By selecting this conversion mode
Interpolation
further entries are required to parameterize the
test and calibration curve.
Unit conversion By pressing into the Unit conversion input field a alphanumerical keypad
opens allowing the entry or modification of the unit/activity for conversion of
the raw value, meaning from sec. into unit/activity, e.g. %, mg/dl, g/l.
Mode in/out By pressing the Select Box arrow button of the left select box you can define
the scaling of the x-axis of the calibration curve graph whereas the right
select box will define the y-axis setting of the calibration curve graph. The
following selections are available for both axis:
• log - logarithmic calculations are applied to values before graphing.

• rec - the reciprocal (1 divided by the value) is used on the graph.
• lin - Linear value is used directly on the graph.
The mode in/out selection lin/lin is the most common setting used. Other
combinations, e.g. log/rec may require certain modifications in the
conversion range values, see Conversion range input field to display the
calibration curve graph.
Output format By pressing the Select Box arrow button you can define the decimal point
setting for the measuring result display. There are 4 alternatives available:
• <xxx.x> Input range: 0.1 - 999.9 (units)

• <xx.xx.> Input range: 0.01 - 99.99 (units)
• <x.xxx> Input range: 0.001 - 9.999 (units)
• <xxxx.> Input range: 0 - 9999 (units)
Rising By using this check box button you may define or modify whether the
expected converted values (unit/activity) of the measuring results are rising
or falling. Set individual parameters On/Off by pressing onto the coloured
field, e.g. OFF= light blue (falling converted values), ON = dark blue (rising
converted values).
Calibration curves must be entered in such a way that you start with the
highest % values and a shortest measuring time (raw value) in seconds for
falling curves (coagulation factors). For rising curves (inhibitors or INR-Cal)
you have to start with the lowest % / INR values and the shortest measuring
times (raw value) in seconds. The software will support this procedure only.

Operation
The arrow marking in the Calib Value page indicate whether the
NOTE
values must rise or fall. Converted values can be set to rising or
falling. Raw values must always rise.
Convers. range By pressing into the Conversion range input field a numerical keypad
opens allowing the entry or modification of the extrapolated result limits
within the results will be calculated and displayed in the calibration curve
graph. Input range: 0.1 - 9999 (depending on defined output format).
2nd conversion By pressing the Select Box arrow button you can select between 3 available
conversion modes to define the 2nd conversion.
The following 2nd conversion modes are available:

nd
No 2 conversion of raw values, results will be
shown in sec. and defined activity only. By
None
selecting none, no further entries for MNPT or ISI
are possible.
Allows conversion of the INR (International
Normalized Ratio). Selecting this conversion
INR mode requires further entry of the ISI
(International Sensitivity Index) as provided by the
reagent package insert.
Allows conversion of the Ratio (Sample / MNPT =

Ratio
mean normal PT or aPTT).
MNPT By pressing into the MNPT input field a numerical keypad opens allowing
the entry or modification of the Mean Normal PT time at 100% activity in
sec. The same input field shall be used for setting the Mean Normal aPTT
time for evaluating the Ratio. Input range: 1 - 300 (sec.).
ISI By pressing into the ISI (International Sensitivity Index) input field a
numerical keypad opens allowing the entry or modification of the ISI value
according to reagent package insert. Input range: 0.01 - 99.99.
The ISI input field only appears if INR is selected in 2nd conversion.

Quit

Operation
OK Press the OK button to return back to the Calibration Menu Main Page.
Enter Calibration Values Press the Calib Values button in Edit Calibration to access the Calibration
Figure 135 Calibration Values 1st evaluation
To enter calibration curve points manually perform one of the following:
Option 1:
1. If available use the values as provided in the package insert of the

Option 2:
• Enter manually the evaluated results achieved by a normal

measurement with dilutions or if available with standard plasmas.
Prior entering the calibration curve values make sure the values correspond
to the following settings:

Operation
• Raw values entered must be inside the defined Valid Clotting range,
see chapter 5.3.4.2 Evaluation.
• Converted values entered must be inside the defined conversion

range, see chapter 5.3.5.1 Edit Calibration for Clotting (manual
calibration), Convers. range
• Values entered must correspond to the rising/falling definition, see

chapter 5.3.5.1 Edit Calibration for Clotting (manual calibration),
Rising
Unit [%] By pressing into the unit, here % input field a numerical keypad opens
allowing the entry or modification of the converted value (unit/activity).
Points on the calibration curve that are not to be used must have the
NOTE entry 0.0%. A minimum of 2 points must be defined. It is
recommended defining at least 3 points. In maximum 7 calibrations
curve points can be defined.
Raw Value [sec.] By pressing into the Raw Value, here sec. input field a numerical keypad
opens allowing the entry or modification of the raw values in sec.
Dilution Within this section the dilution based on the entered values (converted and
raw values and the defined concentration value will be calculated
automatically by the software.
Example: 1+ 9.0 = 1 part standard plasma will be diluted with 9 parts

buffer or a 1:10 dilution.
invalid = The converted value entered deviates from the

following conditions:
1. Value is outside the defined conversion range, see chapter

5.3.5.1 Edit Calibration for Clotting (manual calibration),
Convers. range.
2. Value is higher as the set concentration value, see

Standard / Concentration in this chapter.
Standard This section allows entry of further information on Standard Plasmas used to
verify a calibration curve.
Concentration By pressing into the Concentration input field a numerical keypad opens
allowing the entry or modification of the concentration value of the undiluted
Standard used. The Input range depends on the definition set in chapter
5.3.5.1 Edit Calibration for Clotting (manual calibration), Convers.
range.
Name By pressing into the Name input field an alphanumeric keypad opens
allowing the entry or modification of the name of the Standard used. For
Name entry 15 alphanumeric characters are available.
Lot No. By pressing into the Lot No. input field an alphanumeric keypad opens
allowing the entry or modification of the name of the Standard used. For Lot
No. entry 15 alphanumeric characters are available.

Operation
Tools
The Tools button in the Calibration Value Screen offers several options and
• Press the Tools button to access further additional areas.

Quit
By pressing this button the entered calibration

curve points will be displayed as graph, see
Graph chapter 5.3.5.1 Edit Calibration for Clotting
(manual calibration), Display Calibration
Graph.
By pressing this button the calibration value
Hardcopy screen will be printed, provided a printer is
connected to the analyser.
Display Calibration Graph Press the Graph button to open the graph for the entered calibration curve.
Contents of the boxes that appear on the screen vary depending on the
units selected in the Calibration Menu.
Figure 136 Calibration Curve Graph
A graph with all entered curve points and calibration date & time information
appears.
Tools
The Tools button in the Calibration Graph Screen offers additional options
allowing the graph to be modified, printed and displayed in other scaling
rates.

Operation
Figure 137 Tools in Calibration Graph Screen

Increases the scale of the displayed graph. By
Zoom OUT
(appears only when graph Reduces the scale of the displayed graph.
was zoomed in first)

Zoom RESET
initial setting.
Flip Interchanges the x-/y-axis definition

Quit
To print the calibration curve graph as currently

Hardcopy
shown in the screen.
OK Press the OK button twice to return back to the Calibration Menu Main
Screen.
Undo&Exit By pressing the Undo&Exit button you will leave the Calibration Menu
Save&Exit Pressing the Save&Exit button in the Calibration Menu confirms all changes
and modifications done in this menu. Prior of acceptance the software will
check conformity on all edited parameters. In case of any invalid inputs the

Operation
5.3.5.2 Edit Calibration for Kinetic / Diff. /

1st devi (manual calibration)
• Select Kinetic/Diff./1st devi. by using the arrow keys to enter calibration

parameters for tests not using seconds as raw values or to define
parameters for a test using 2nd evaluation.
Basically this section is structured in the same way as already described in

chapter 5.3.5.1 Edit Calibration for Clotting (manual calibration). For
further entry of calibration parameters based on the 2nd evaluation only the
differences will be outlined in the following.
Calculation Press the Calculation button to access the Calibration Menu for Clotting,
the following window appears. Contents of the boxes that appear on the
screen vary depending on the units selected in the test.
Figure 139 Calibration Menu Kin/Diff/1st devi

Operation

in mE (milliExtinction) only. By selecting none, no
None
further entries on this page are required. No
calibration curve is measured.
Interpolation
the raw value, meaning from mE into unit/activity, e.g. mg/dl, mg/l.

The mode in/out selection lin/lin is the most common setting used. Other
conversion range values, see Conversion range input field to display the
calibration curve graph.

converted values).
highest converted values and a highest measuring time (raw value) in mE
for falling curves. For rising curves you have to start with the lowest
converted values and the highest measuring times (raw value) in mE. The
software will support this procedure only.

Operation
NOTE values must rise or fall. Converted values can be set to rising or

Quit
Enter Calibration Values Press the Calib Values button to access the Calibration Menu for Kinetic,
Difference or 1st Deviation, the following window appears. Contents of the
boxes that appear on the screen vary depending on the units selected in the
test.

Operation
Figure 141 Calibration Values 2nd evaluation
To enter calibration curve points manually perform one of the following:
Option 1:
2. If available use the values as provided in the package insert of the

Option 2:
• Enter manually the evaluated results achieved by a normal

measurement with dilutions or if available with standard plasmas.

range, see chapter 5.3.5.2 Edit Calibration for Kinetic / Diff. / 1st devi
(manual calibration), Convers. range.

chapter 5.3.5.2 Edit Calibration for Kinetic / Diff. / 1st devi (manual
calibration), Rising
Unit [mg/dl] By pressing into the Unit, here mg/dl input field a numerical keypad opens
Raw Value [mE/min] By pressing into the Raw Value, here mE/min. input field a numerical
keypad opens allowing the entry or modification of the raw values in sec.

Operation

invalid = The converted value entered deviates from the

following conditions:

5.3.5.2 Edit Calibration for Kinetic / Diff. / 1st devi,
Convers. range.
2. Value is higher as the set concentration value, see

Standard / Concentration in this chapter.
Standard used. The Input range depends on the definition set in chapter
5.3.5.2 Edit Calibration for Kinetic / Diff. / 1st devi, Convers. range.
Tools
The Tools button in the Calibration Value Screen offers several options and
Figure 142 Tools in Calibration Value Screen

Operation

Quit
By pressing this button the entered calibration curve

points will be displayed as graph, 5.3.5.1 Edit
Graph
Calibration for Clotting (manual calibration),
Display Calibration Graph.
By pressing this button the calibration value screen

Hardcopy will be printed, provided a printer is connected to the
analyser.
OK Press the OK button to return back to the Calibration Menu Main Screen.

Operation
5.3.5.3 Auto Calibration for Clotting

(automated calibration)
The following chapters will describe how to perform an automated

calibration on the system. The following procedures will be described using
Fibrinogen as an example. Perform all other tests in the same way.
Menu.
• From the Setup Menu, press the button Calibration to access the
Calibration Menu.
Figure 144 Select test Calibration
The Select Test Screen for calibration contains a list of all tests available.
• Select a test for calibration, here Fibrinogen by using the arrow keys
first to select the test and then press the OK button to continue.

Operation
The calibration for test screen appears.
Chose mode of calibration First select between the 2 available calibration modes by pressing the Select
Box arrow button. The different modes define how the raw value of a
calibration curve are converted and further allows entry of calibration
parameters for tests requiring 2 different calibration curves, for example
derived Fibrinogen.
The following calibration modes are available:
Calibration modes Description
Converts raw values [sec.] into a defined

Clotting
unit/activity.
Kinetic: Converts raw value [mE/min.] into a

Kinetic / Difference /
Difference: Converts raw value [delta mE] into a
1st deviation
1st devi.: Converts raw value [mE/sec.] into a
Before selecting the calibration mode in this screen the

NOTE corresponding evaluation mode must be assigned to the test first,
see chapter 5.3.4.2 Evaluation to assign the 1st and or 2nd
evaluation to a test also defining whether the test allows entry of 2
calibration curve parameters.
• For Fibrinogen select Clotting by using the arrow keys to enter

calibration parameters.
Prior starting an Auto Calibration make sure the following has been done:
• The reagent supposed to be calibrated must be set to calibrate, see

chapter 5.3.3.1 Parameter Page 1, Calibrate.
• The reagents and diluents required for the test calibration must be
loaded on the analyzer and available in reagent area of the system. See
chapter 5.2.2 Load Reagents.

Operation
Calculation Press the Calculation button in Edit Calibration to access the Calibration
Figure 146 Calibration Menu Clotting

in seconds only. By selecting none, no further
None
entries on this page are required. No calibration
curve is measured
Interpolation
the raw value, meaning from sec. into unit/activity, e.g. %, mg/dl, g/l.

• The mode in/out selection lin/lin is the most common setting used. Other
conversion range values, see Conversion range input field to display
the calibration curve graph.

Operation

converted values).
highest % values and a shortest measuring time (raw value) in seconds for
falling curves (coagulation factors). For rising curves (inhibitors or INR-Cal)
you have to start with the lowest % / INR values and the shortest measuring
times (raw value) in seconds. The software will support this procedure only.
NOTE values must rise or fall. Converted values can be set to rising or
2nd conversion By pressing the Select Box arrow button you can select between 3 available
conversion modes to define the 2nd conversion.
The following 2nd conversion modes are available:

nd
No 2 conversion of raw values, results will be
shown in sec. and defined activity only. By
None
selecting none, no further entries on this page are
required.
Allows conversion of the INR (International
Normalized Ratio). Selecting this conversion
mode requires further entry of the ISI
INR
(International Sensitivity Index) and the MNPT
(mean normal PT) as provided by the reagent
package insert.
Allows conversion of the Ratio (Sample / MNPT =

Ratio
mean normal PT or aPTT).
For Fibrinogen a 2nd conversion is not required and should be set to none.

Operation

Quit
Enter Calibration Values Press the Calib Values button in Edit Calibration to access the Calibration
Figure 148 Calibration Values (concentration)

Operation
Within this window certain entries are required manually.
Unit [g/l] First enter the concentration/converted values steps for the standard used.
By pressing into the Unit, here g/l input field a numerical keypad opens

range, see chapter 5.3.5.1 Edit Calibration for Clotting (manual
calibration), Convers. range

chapter 5.3.5.1 Edit Calibration for Clotting (manual calibration),
Rising
Raw Value [sec.] When performing an automated calibration the entry of raw values is not
required. There may be raw values available already which have been
calculated from the last calibration.

invalid = The converted value entered deviates from the following

conditions:

5.3.5.1 Edit Calibration for Clotting (manual calibration),
Convers. range
2. Value is higher as the set concentration value, see Standard /

Concentration in this chapter.
Standard used. The Input depends on the definition set in chapter 5.3.4.1
Liquids, Buffer/Diluent., please refer to explanation as provided below.

Operation
The concentration value entered for automated calibration depends

NOTE on the entry of the dilution ratio as defined in the Test Setup for the
particular test, see chapter 5.3.4.1 Liquids. The dilution value
Buffer/Diluent as defined in Test Setup/Liquids must be multiplied
with the value of concentration required for this test.
Example:
Test Setup/Liquids is set to a 1+9 dilution for Fibrinogen.
The concentration value required is 2,8 g/l.
Multiply 2.8g/l with the dilution ratio of 1+9, i.e. 10 = 28.00 g/l
Enter 28.00 g/l into the concentration field by using the numerical
keypad. This is important to ensure correct measurement of your
calibration values in order to avoid invalid dilutions.
The lowest pipetting volume is 2µl that means when having a

NOTE sample volume of for example 100µl the max. dilution may not
exceed 1+49 ( 2µl + 98µl).
OK Once these data have been entered leave this menu by pressing the OK
button to return back to the Calibration Menu Main Screen.

Operation
Auto Calibration In section Auto Calibration the following settings can be done prior to finally
start the automated calibration.
Diluent A diluent can be selected by pressing onto the button. The selection of a
diluent may only be possible if a reagent is used for calibration which does
normally not require a buffer or a sample does not require dilution, for
example PT.
Tests to which a buffer is assigned to already do not require the selection of

a diluent in this case the button will be displayed grey. The reagent buffer is
used s diluent for calibration.
Cup Select the type of cup which shall be assigned to the control & calibrator
position by pressing the assigned radio button. Control & calibrator cups
may be placed in the controls/calibrator positions (C1-C8), see below
picture. During the auto calibration run the software will provide information
on what position must be used.
Figure 150 Control & Calibrator Positions C1-C8
No. of Determination By pressing into the No. of Determ. input field a numerical keypad opens
allowing the entry or modification of the number of determination (single or
multiple) assigned to a test for calibration.
Input range: 1 - 2 (Default = 1).
Is the number of determination set to multiple, meaning > 1 the maximum

deviation must be defined to specify to what extent each single value may
deviate, see Max. Deviation.
Make sure the number of measurements for the automated

NOTE
calibration always corresponds to the available number of cuvettes
available in the cuvette ring used for this run. Auto calibration runs
can not be divided into two cuvette rings.
Max. Deviation By pressing into the Max. Deviation (CV) input field a numerical keypad
opens allowing the entry or modification of the maximum deviation in %. The
maximum deviation indicates the permitted deviation of the measured
values for multiple determinations. This field only appears if the No. of
Determination is set to > 1. Input range: 0 - 20 (%); 0=off.
Once the single values are outside of this range the single values will be
marked by the software.

Operation
Start After all data has been entered and all reagents/diluents have been placed
on the system he auto calibration can be started.
Press the START button to perform the automated calibration run and the
following Info Message box appears.
Below message appears. Place the control/calibrator cup into position C1

within the reagent area of the analyzer and confirm message by pressing the
OK button.
Figure 151 Place Calibrator Position 1
If an assigned test buffer is used as diluent a corresponding message

appears for a moment.
If the diluent must be provided separately, a message appears requesting to

place a calibrator in position ‘control 2’.
After confirming this message by confirming this message with OK, the level
sensor checks if liquids are available.
Volume quantity is not calculated for control position 1 and 2. Make

NOTE
sure enough calibrator and diluent is available.
The following window provides information related to the current available

joblist.
Figure 152 Reagent Status List Calibration

Operation
The following information is available:
Available information Description
Provides information on the loaded reagents

Reagent Status List and washers, its required volumes, loaded
volumes, stability and lot numbers.
Provides information on the cuvette ring loaded:

- Start Cuvette No.
Cuvettes
- Required cuvettes for the run
- Free cuvettes available on the loaded ring
Tools The Tools button in the Measurement Menu offers several options and
Figure 153 Tools in Calibration Measurement Menu
By pressing this button the screen will be printed,

Hardcopy
Quit
Opens the timeline window showing each step of
Timeline the joblist entered in a diagram and provides run
time information.
Exit Select Exit to return to the MAIN MENU.
Start the Run Select Start the Run to begin measurement.
• Below message appears. Close the shield of the analyser and confirm
message by pressing the OK button.

Operation
Figure 154 Close Shield Message
The analyser starts preparing the measurement and starts the run if there is
no pending problem. Results and/or related run information are shown in this
window once available.
Figure 155 Running Measurement Calibration
Tools The Tools button in Running Measurement offers several options and

Operation
Figure 156 Tools in Calibration Measurement Menu
By pressing this button you enter into the result

Results
list.
By pressing this button you will print the screen,

Print

Quit
By pressing this button you will see the reaction

R-Curve
curve graph of the current run in real time.

Timeline
of the joblist entered in a diagram.
Show/print reaction curves To display reaction curves of the current auto calibration run press the
button R-Curve, the following window appears:
Figure 157 Reaction Curves Calibration

Operation
• From the R-Curve window press the OK button to return to the Running
Measurement screen or press Hardcopy to print the current screen.
Figure 158 Running Measurement Calibration
Once the auto calibration run is finished all available results will be displayed
in the Results of last run list, the following display appears:
Figure 159 Results/Run List Calibration
In the Results of last run list all results of the last auto calibration run will be
displayed as follows:
• If double determination has been selected prior to the auto

calibration run the results listed are the mean values from both
determinations.
• When single determination was selected the results for each

measurement will be displayed.
• Results which have a colored background indicate a problem

occurred during measurement, for example a deviation error. Such
results marked as “none” in the list will be entered into the calibration
curve raw value data as 0.0 sec.
Print By pressing the Print button the Results of last run list will be printed on your
external printer. Once these data have been entered leave this menu by
pressing the OK button to return back to the Calibration Menu Main Screen.

Operation
OK Leave this screen by pressing the OK button to return back to the

Calibration Menu Main Screen.
Figure 160 Warning Message Calibration
The following message appears. If you intend to overwrite the current

calibration values with the latest values measured press the Yes button. To
keep the current calibration values press the No button.
The following message appears in case any problems occurred during the
last calibration run. See chapter 6.2.2 Error Flags in the Results/Run or
Results/Memory List to identify error codes in this screen.
Figure 161 Warning Message Measuring Status
Confirm this message by pressing the OK button, the following display

appears:

Operation
Figure 162 Auto Calibration finished
The auto calibration run has now finished, all measured data have been
added to the calibration curve/data. Confirm this message by pressing the
OK button, the following display appears:
Calib. Values To verify and view the calibration data and curve press the Calib Value
button. The following display appears:
Figure 164 Calibration data

Operation
In above example no raw value [0.0 sec] was measured for 0.60 g/l
concentration due to low signals for this high dilution. There are 2
possibilities to fix the problem:
a. Enter “0” into the g/l field by overwriting the “0,60” g/l entry. A “0” in the
concentration will not be used for calibration curve data
b. Enter a value greater than 30,7 [sec] for this calibration step.
Show calibration curve By pressing the Tools button followed by the Graph button the latest
calibration curve will be displayed.
Figure 165 Calibration Curve
Tools
The Tools button in the Calibration Graph Screen offers additional options
allowing the graph to be modified, printed and displayed in other scaling
rates.
Figure 166 Tools in Calibration Graph Screen

Operation

Increases the scale of the displayed graph. By
Zoom OUT
(appears only when graph Reduces the scale of the displayed graph.
was zoomed in first)

Zoom RESET
initial setting.
Flip Interchanges the x-/y-axis definition

Quit
To print the calibration curve graph as currently

Hardcopy
shown in the screen.
OK Press the OK button twice to return back to the Calibration Menu Main
Screen.
Print By pressing the Print button the complete calibration data, results and curve
information will be printed.

Operation
5.3.6 Delete Results

The button Delete Results in the Setup Menu allows you to clear the result
ring memory list.
By confirming the delete results message with Yes will delete all
NOTE available results from the ring result memory of the analyser. There
will be no option to recover these results once deleted.
Figure 167 Delete Results
• Press the Delete Results button, the following message appears.
Figure 168 Delete Results Message Box
Press the Yes button if you intent to delete all results from the result ring
memory list. By pressing No all available results will be kept safe in the
result list.

Operation
5.3.7 Setup Language

The button Language in the Setup Menu allows you to install further
software languages or to set the software language to factory default
(English).
Figure 169 Setup Language
• Press the Language button, the following message appears.
Figure 170 Select Language
The following Selecions are available:
Selections Description

Quit
By pressing this button the software language

English
will be reset to English.
By pressing this button the software language

Deutsch
will be reset to German (Deutsch).

Operation
5.3.8 Setup Date & Time

The button Date & Time in the Setup Menu allows you to set the actual date
& time information of the analyser.
Figure 171 Setup Date & Time
• Press the Date & Time button, the following message appears.
Figure 172 Date & Time Settings
• By pressing into the Date input field a numerical keypad opens allowing
the entry or modification of the date. Input format: dd.mm.yyyy
• By pressing into the Time input field a numerical keypad opens

allowing the entry or modification of the date. Input format: hh:mm:ss
Undo&Exit By pressing the Undo&Exit button you will leave the Date & Time Menu
Save&Exit Pressing the Save&Exit button in the Date & Time Menu confirms changes
and modifications done in this menu. . The system will re-start to set the new
entry of Date & Time.

Operation
5.3.9 Change Password

The button Passwords in the Setup Menu allows you to set or change
certain PIN Codes (5 digits) required to access different levels of the
software.
The Passwords Menu can only be entered in the software level expert, see
chapter 3.2 Software.
Figure 173 Change Password
• Press the Passwords button, the following message appears.
Figure 174 Setup Password
• By pressing into the Expert input field a numerical keypad opens

allowing the entry or modification of the current PIN Code for the expert
level. Input format: 0 - 99999.
Tools The Tools button in the Password Menu screen offers additional options
and access to other menus and features.

Operation

Quit
Undo&Exit By pressing the Undo&Exit button you will leave the Password Menu
Save&Exit Pressing the Save&Exit button in the Password Menu confirms changes
and modifications done in this menu.
5.3.10 Setup Beeper

The check box button Beeper in the Setup Menu allows you to activate
acoustical response performed by the analyser software in case of warning
messages or problems occur.
Figure 175 Setup Beeper
• By using this check box button you may define whether the beeper shall
be active or set inactive. Set individual parameters On/Off by pressing
onto the coloured field, e.g. OFF= light blue (beeper inactive), ON = dark
blue (beeper active).

Operation
5.3.11 Setup STAT Autoprint

The check box button STAT Autoprint in the Setup Menu allows you to
activate an automated result print function when STAT results are available.
Figure 176 Setup STAT autoprint
• By using this check box button you may define whether the results of a
STAT measurement will be automatically printed once available. Set
individual parameters On/Off by pressing onto the coloured field, e.g.
OFF= light blue (STAT autoprint inactive), ON = dark blue (STAT autoprint
active).
5.3.12 Define Headline

The input field Headline in the Setup Menu allows you to enter a head line
title used on every printout performed by the analyser. The headline may be
used to define the name of the analyser or to identify the respective
department the analyser is used.
Figure 177 Define Headline
• By pressing into the headline input field an alphanumeric keypad opens

allowing the entry or modification of the headline. For headline entry 15
alphanumeric characters are available.

Operation
5.3.13 Initiate Analyser Selftest

The button Selftest in the Setup Menu allows you to check the general
analyser functions at any time. This system test will initiate a check up of all
positions, pumps and level detection to determine any failure possibly
existing.
Figure 178 Selftest
• Press the Selftest button to start the self test sequence of the analyser.
At first the photometer transmissions will be checked.
Figure 179 Selftest Transmission
• Confirm this message by pressing the Yes button. Now the analyser
starts checking all available positions, modules and guides you through
a full selftest procedure. Any failures will be outlined and require
confirmation. Each successful check must be confirmed by pressing the
OK button. After successful testing procedure the following message
appears:

Operation
Figure 180 Selftest finished
• After successful finalization of the Selftest sequence confirm this

message by pressing the OK button to return back to the Setup Menu
Main Screen.
Tools The Tools button in the Setup Menu offers additional options and access to
other menus and features.

Quit
OK By pressing the OK button you will return to the Main Menu.

Operation
5.4 Switch off analyser
To switch off the analyser follow the next steps as described in below
section.
• From the Main Menu, press the button Shutdown.
Figure 182 Shutdown Analyzer
The following selection appears:
Figure 183 Shutdown Selection
The following Selection is available:

Quit
By pressing this button you will shut down the
Switch Off software. Switch off mains to finally turning off
analyzer.
By pressing this button the analyzer will initiate
Restart
a system restart.

Safety in operation
6 SAFETY IN OPERATION
6.1 Maintenance and Hygiene
Refer to this chapter for the recommended maintenance schedule and

procedures for maintaining the analyzer.
To obtain accurate and precise results the manufacturer recommends

cleaning and maintaining the system on a regular basis. Disregarding these
instructions may cause contamination and operational failures of the system
and may also lead to the manufacturer’s warranty becoming null and void.
Carefully observe the following cleaning and hygiene instructions:
Do not use organic acids for cleaning the instrument. Always use the
surface cleaning agents recommended by the specialist trade for this
purpose. Always use a moist cloth; do not spray on or pour on any liquids,
as they can affect the correct function of the instrument or damage it.
Caution!
Keep the instrument free from dust and liquid spillages. When not used for a
prolonged period, place a dust cover over the instrument or place it in a
cabinet.
If liquid has been spilled on the instrument, remove the contamination with a
clean, absorbent non-woven cloth considering all applicable hygienic
requirements.
If liquid has accidentally entered, or been pipetted into a measuring

channel, remove the liquid with a pipette and then clean the measuring
channel with a lint-free cloth. Please consider all applicable hygienic
requirements.
Contact our technical service if subsequent control measurements do not

produce the expected result.
The Analyser is fitted with a lithium battery type Li-Mn CR 2430 (life
approx. 5 years). It should be replaced by an authorised service operator
after 5 years at the latest. Otherwise a faultless operation can not be
guaranteed.
Before performing any task in this chapter, review the hazard and
NOTE precautions listed in chapter 2 HAZARD AND PRECAUTIONS of this
manual.
Power down the analyzer and disconnect the power cord from the facility
NOTE power for all cleaning tasks.

Safety in operation
6.1.1 Maintenance frequency
Step Cycle Service needed

daily weekly monthly yearly yes no
Clean working plate X X
Run a flush cycle X X
Run a washing cycle using Washing

X X
Solution
Clean tubing using Cleaning
X X
Solution
Clean end of pipettor X X
Clean distilled Water Container and

2x X
sensor (70% alcohol solution)
Clean Waste Water Container and
2x X
sensor (70% alcohol solution)
Clean the housing (70% alcohol
X X
solution)
Replace fresh water filter at distilled
X X
water sensor (green)
X
Replace tubing’s X
X
Replace 250 µl syringe X
Replace distilled + waste water

X X
container
Replace pipettor (recommended) X X
Replace dilutor valve (recommended) X X
6.1.2 Cleaning of the housing

The housing and working plate of the analyzer should be cleaned in regular
intervals to avoid any contamination.
NOTE Do not use organic acids, bleach, Sodium Hypocloride or

Glutaraldehyde.
Only use the Cleaner according to the instructions provided or 70% alcohol
for cleaning. Use a dampened cloth. Never spray or pour any liquids onto or
into the system which may negatively impact the analyzer’s functions.
If liquids have accidentally run into the system contact the customer service
of the distributor or the manufacturer.

Safety in operation
Avoid any direct skin contact with samples and/or test reagents as
well as those parts of the instrument which might be contaminated
NOTE
with samples and/or test reagents.
These parts are potentially infectious. If samples were spilled onto
the system wipe them off immediately and disinfect the
instrument. Reagents might irritate the skin or mucous
membranes. Observe the manufacturer’s instructions in the
package insert how to handle the reagents properly.
Make sure to dispose of the sample and test material in compliance
with biohazard and legal provisions.
6.1.3 Clean Pipettor

The pipettor must be free of damages and deposits. To clean the end of the
pipettor:
• Shut down software.
• Power down the analyzer and remove the power cord.
• Open the safety shield.
• Clean the bottom end of the pipettor (steel tubing) with a lint-free cloth
(or tissue) soaked with a 70% alcohol solution. Use care to avoid
bending of the probe.
NOTE Never use bleach to clean the pipettor.

Safety in operation
6.1.4 Clean Containers/Sensors

Replace Filter
The containers and level sensors must be cleaned in regular intervals to
avoid contamination and the risk of inaccuracy of the measuring results.
Additionally it is recommended to replace the white filter at the end of the
distilled level sensor (green) on a monthly basis.
To clean the containers/sensors and replace the filter:
• Shut down software.
• Power down the analyzer and remove the power cord.
• Remove the distilled water (green) and waste water (red) level sensors
from the containers and disconnect them from the analyzer, see chapter
3.1.7 Rinsing System and 4.3.2 Connecting the Rinsing System.
• Remove the white fresh water filter from the end of the Distilled Water
Sensor.
• Clean both sensors and the end of the sensors using a 70% alcohol
solution and rinse them with distilled water to remove any traces of the
alcohol solution.
• Place a new fresh water filter at the end of the distilled water sensor
after cleaning.
• Empty the distilled water and waste water container and clean the inside
using a 70% alcohol solution.
• Rinse both containers thoroughly with distilled water to remove any

traces of the alcohol solution.
• Refill the distilled water container using fresh distilled water. The
container should have a minimum of 1 litre. Make sure no air bubbles
remain in the container. Use Distilled Water (aqua dest.) only!
• Connect the level sensors back to the analyser, see chapter 4.3.2
Connecting the Rinsing System and place back the sensors again
into the corresponding containers.
6.1.5 Perform cleaning cycle

It is necessary to clean the liquid system, tubing’s at regular intervals to
avoid reagent or sample residues, possibly causing inaccurate results or
improper functioning of the analyzer. Therefore, regular cleaning cycles
must be run to guarantee proper functioning of the system.
Carefully read the package insert supplied within the Cleaner box.
NOTE Also take note to the information as provided in the package insert to
ensure proper use and handling of the cleaner.
To clean the liquid system:

Safety in operation
• Place a 12ml bottle of Cleaner (supplied materials) into the reagent area
position W2, see chapter 3.1.2 Working Plate. Make sure to remove
the lid prior of placing the bottle into its position.
display appears.
Figure 184 Perform Cleaning Cycle
• Use the Select Box arrow buttons in the “Rinsing Modes” frame until
cleaning cycle appears in the select box, see above picture.
• By pressing the button Perform the cleaning procedure starts. The

analyser will rinse the system using the Cleaner provided.
Cleaning procedure:
- 200µl Cleaner
• This procedure should be repeated at least 3 times until the tubing’s

and liquid system is completely cleaned.
• After final cleaning cycle perform another flush cycle. Use the Select
Box arrow buttons in the “Rinsing Modes” frame until Flush 10s
appears in the select box.
• By pressing the button Perform the flush cycle starts. The analyser will
rinse the system with system water (distilled water). Repeat this
procedure 3 times to ensure no Cleaner remains in the liquid system.
If necessary repeat the flush procedure until no foam residues of

NOTE Cleaner will remain in the liquid system, waste tubing (red marked).
Check if waste water runs through the waste tubing into the Waste
Water Container and no foam remains in the waste tubing.
After finalization of the Cleaning cycle make sure to remove the

NOTE Cleaner bottle again from position W2 in the reagent area.

Safety in operation
6.1.6 Perform washing cycle

Especially after the use of reagents containing thrombin, like Fibrinogen it is
recommended to perform washing cycles to avoid carry over.
To perform a washing cycle:
• Place a 15ml bottle of Washing Solution (supplied materials) into the

reagent area position W1, see chapter 3.1.2 Working Plate. Make sure
to remove the lid prior of placing the bottle into its position.
display appears.
Figure 185 Perform Washing Cycle
• Use the Select Box arrow buttons in the “Rinsing Modes” frame until
Intensive 1 appears in the select box, see above picture.
• By pressing the button Perform the washing procedure starts. The

analyser will rinse the system with washing solution.
Washing procedure:
- 150µl Washing Solution (W1)
• This procedure should be repeated 2 times until the pipettor is

disinfected.
• After final washing cycle perform another flush cycle. Use the Select
Box arrow buttons in the “Rinsing Modes” frame until Flush 10s
appears in the select box.
• By pressing the button Perform the flush cycle starts. The analyser will
rinse the system with system water (distilled water). Repeat this
procedure 2 times to ensure no washing solution remains in the liquid
system.

Safety in operation
6.1.7 Protocol of Maintenance Check

The manufacturer recommends recording all maintenance check-ups of the
system in which all service, maintenance and repair, replacement of parts,
cleaning and disinfection cycles will be documented.
If the customer service has to repair or replace parts on the system you
should make the maintenance check protocols available. This might simplify
the repair.
6.1.8 How to dispose of used

disposables
Remember to dispose of used cuvette rings, primary/secondary tubes, and
reagent vials in compliance with legal provisions.
All disposables used with the system must be treated as

NOTE
potentially infectious. Avoid any skin contact with sample and
reagent material which might be on the disposables.
Dispose of used disposables in compliance with legal provisions or
laboratory regulations. Do not put used disposables, samples and
reagents into the usual garbage.
Cuvette rings might not be resistant to organic acids. Therefore do

not use organic acids unless they are expressly permitted.
6.1.9 Disposal of the Analyser
The following must be considered when disposing of the Analyser:
• The upper and lower part of the housing is made of polyurethane foam.
• Mechanical parts are predominantly made of aluminium and precious

metals.
• Electronic parts must be disposed of in accordance with national

directives for the disposal of electrical parts.
• For the safety of the operating personnel make sure the Analyser has
been disinfected before disposal.

Safety in operation
6.2 Troubleshooting
Faults may caused by actions during use and/or by the system. The
analyzer displays error messages and warnings in the display and outputs
these via the printer, provided an external printer is connected.
Additionally irregularities and errors may appear in the Status
6.2.1 Application errors

Application errors may cause incorrect results. Possible causes are:
• Air bubbles are in the cuvette.
• The temperature of the start reagent deviates from 37°C.
• The reagent has been placed incorrectly.
• The sample or control is too old.
• No stir bar has been placed into the cuvette.
• Reagents have been carried over (PT or Fibrinogen reagent).
• A reagent with the wrong lot number has been used.
• The reagent has not been used according to the package insert.
• The reagent used does not correspond to the test selected.
• No or an incorrect calibration curve is applied to the reagent lot.
• Errors appeared during the sample collection or centrifugation.
• No stirrer is placed into the reagent vial.
• Method parameters relevant for measuring are incorrect.
• Reagent vial size placed in the reagent area does not correspond to the
reagent vial parameterized in Load Reagent.
• Sample vial size placed in the sample area does not correspond to the
sample vial parameterized in Load Samples.
Should any of these errors occur and they are recognized in time, they must
be remedied immediately.
Certain of these errors can only be recognized when determining control

plasmas.
As a result we recommend running control plasma on a daily basis prior to

running routine determinations.

Safety in operation
6.2.2 Error Flags in the Results/Run or Results/Memory List
Error Cause Action

State: OK The measurement has been finished with None
no problems.
none No clot has been found within the set Check test settings, see chapter
measuring time and valid clotting range. 5.3.4.2, valid clotting, auto repeat
and measuring time
State: D Deviation Error: Check reagent and test settings

The specified mean value deviation set in are correct, widen max. deviation
the Test Setup is exceeded. range. Repeat test.
State: T Temperature Error: Call customer service

Temperature problems occurred at pipettor
or rotor
State: M Mixer Error: Call customer service

The mixer motor(s) do not properly work.
State: S Reagent Mixer Error: Call customer service

The reagent mixer motor does not properly
work.
State: F Photometer Error: Call customer service

A photometer error was detected during the
measurement.
State: L Liquid Error: Check liquid levels of all used

Not enough reagent or sample available liquids and refill if necessary.
during the run.
6.2.3 Errors during operation
Error Cause Action

No function shown after Power supply o.k.? Fuse o.k.? Check if correct power supplied,
switching on the device. Power cable connected correctly? check fuses
Analyzer fails during Power supply failure, fuse, power cable Check if correct power supplied,
operation loose? check fuses
There are air bubbles in the Analyzer was not filled with system water Check the screw connections of
pipettor tubing correctly. Dilutor tubing is not tight. the pipettor tube. Rinse with
system DI water, see chapter
5.1.3.
No free reagent position, The reagent area is fully loaded, no free Remove reagents from the
test could not be loaded. positions remain available to load more reagent area which may not be
reagents used for the next run.
No enough cuvettes The current joblist requires more cuvettes Cuvette ring carries 32 cuvettes.
as provided by the inserted cuvette ring. Run same number of samples
first and continue additional
samples using a new cuvette ring.

Safety in operation
Error Cause Action

Test has no valid calibration Test applied for a run has no valid Enter calibration data for this test
calibration. first, see chapter 5.3.5
Reagent has no valid The stability of a reagent has timed out. Renew reagent stability, see
stability chapter 5.2.2, 5.3.3.1
Not enough liquids, out of The liquid volume required for a run does Refill the liquid missing according
liquid (reagent, washer, not correspond to the volume loaded. to the quantity required.
sample)
System-Water is EMPTY The dist. water container is empty Refill the system water container,
see chapter 4.3.2, 6.1.4
Waste-Water is FULL The waste water container is full Empty and clean the waste
container, see chapter 6.1.4
System-Water is N.C. System water plug (green level sensor) is Correctly connect the system
not connected water connector, see chapter
4.3.2
Waste-Water is N.C. Waste water plug (red level sensor) is not Correctly connect the waste water
connected connector, see chapter 4.3.2
Value out of range, reset to The value entered for a certain parameter is Value will be set to the max.
max. value. out of the maximum input range. allowed input value automatically,
check correctness of parameter.
Value out of range, reset to The value entered for a certain parameter is Value will be set to the min.
min. value. out of the minimum input range. allowed input value automatically,
check correctness of parameter.
Temperature errors Errors occurred at rotor, pipettor which Call customer service
prevent components to reach correct
operating temperature.
No level found in No liquid level could be found at the Check is reagent/washer was
position…. reagent/washer placed. placed correctly and liquid is
available.
LOCKED: Rotor out of The measuring and C-Ring rotor does not Check STATUS Menu for more
Temperature! reach its required temperature. information. If problem persists
contact technical service
Level in Wash Station too The pipettor could not detect system water Check if enough system water is
low for Dip-In in the wash station. This may be caused by in the container (green) and the
a DI pump malfunction of defective pipettor level sensor is connected
level detection. correctly. If problem persists
contact technical service.
Still wet in Wash Station Wash Station is full of system water. This Check if waste container (red) is
may be caused by a waste pump failure empty and level sensor is
and/or a level detection error. connected correctly. If problem
persists contact technical service.
Pumps + Level detection During initialization/test a problem related to Check pumps and correct
test failed! Measuring etc. is the pumps (DI/waste) and/or level detection connection of level sensors.
locked! (sensors) was discovered. Restart system. If problem

Safety in operation
Error Cause Action

Error 1: a) Level at pos. During initialization/test a problem related to Check pump and correct
xxx. Check for: Waste the waste pump and/or level detection was connection of level sensors.
pump failure! discovered. Restart system. If problem
Error 1: Hardware_o.c, line Pipettor moving error in Z-direction or Check if there is any blockage of
xxx; Z is blocked at xxxx pipettor malfunction, wiring of pipettor the pipettor, remove and restart
system. Check cable connection.
Otherwise contact customer
service.
Error 2: Servos.c, line xxx, Pipettor moving error in X-direction or Check if there is any blockage of
Position_Error, mot=XMOV pipettor malfunction, wiring of pipettor the pipettor, remove and restart
system. Check cable connection.
Otherwise contact customer
service.
Error 1: Stepper.c, line xxx, Dilutor moving error (motor) or malfunction Check if there is any blockage of
StepRun timeout. of motor. the dilutor, remove and restart
system. Check cable connection
and motors. Otherwise contact
customer service.
Error 1: Stepper.c, line xxx, Syringe can not move as expected. Check if there is any blockage of
StepGotoPos INVALID the syringe, remove and restart
system. Check for correct
installation of syringe. Otherwise
contact customer service.
No printer found! External printer is not connected of not Check printer is correctly
powered on. connected to the USB interface,
power on printer.
Wrong license code. The entered license code to update the Check license code was entered
Software remains locked software is incorrect or entered wrong correctly, otherwise contact
customer service.
New Cuvette Ring not Cuvette Ring inserted incorrect. Insert Cuvette Ring and check
found correct insertion.
Not all cuvettes are clean Some cuvettes have found to be dirty/used. Insert new cuvette ring, check if
any cuvettes are used.
Cuvette Ring missing No Cuvette Ring was placed in rotor Place Cuvette Ring in rotor prior
start of measurements.
Invalid Customer ID Customer ID number on CuvCARD does Contact technical service

not correspond to cuvette type used.
Invalid Cuvette ID Cuvette type on cuvette card does not Contact technical service
correspond to cuvette type on analyser.
CuvCARD not compatible Utilized CuvCARD may not carry cuvette Try other cuvette card or contact
with analyzer asset or is a wrong card. technical service.
CuvCARD write error. No Inserted card type may be defect. Re-insert card and repeat
booking done. process, otherwise contact
technical service

Safety in operation
Error Cause Action

Balance and reserve fully The cuvette ring balance and reserve Insert new CuvCARD and load
used quantity is now fully used, no further new balance to analyser, once
measurements are possible. the cuvette balance and reserve
quantity is used.
CuvCARD devalued! Cuvette ring balance on CuvCARD is fully Use new CuvCARD delivered
used, CuvCARD is empty! with cuvettes boxes.
Only reserve Message provides information that only Prepare to load new CuvCARD
measurements are certain reserve measurements are available and order new cuvette rings.
possible. for measurements.
After current C-Ring further The measuring channels will be locked Load new cuvette balance to
measurements are locked. once the current C-Ring is fully used. analyser

Safety in operation
6.2.4 How to change fuses

The analyser has a Power Supply Unit (PSU) for a wide voltage range so
that it can be used in a power supply range from 100-240V, 50/60Hz. Fuses
may need to be changed if the analyzer does not operate even though it is
properly connected.
Only replace the analyzer fuses with fuse types specified by the
manufacturer. Observe the information on the serial number plate on the
analyser backplane. The system is supplied set to 240V.
Only use fuses that meet the following requirements:
5A/250 V time lag (T5A L250V)

IEC 60127-2/III
To change fuses follow the procedure below:
• Switch off analyzer.

• Disconnect analyzer from power supply and remove cable.
• Carefully lift the fuse holder with a screw driver. Refer to figure below.
Tab to open the fuse carrier
Fuse carrier
Main switch - ON or OFF
Pivot of cover
Power plug
Figure 186 Change fuses, voltage selector
A red fuse carrier (= voltage selector) becomes visible.
• Set the screwdriver in the upper slot of the fuse carrier and drive
carrier out of the housing.
• Check fuses to see if wires have melted and replace accordingly.
• Insert fuse carrier into the housing again.
• Close cover of the fuse carrier.
• Reconnect analyzer to power supply and check proper operation.
NOTE
Contact authorized customer service in case the exchange of fuses
has been unsuccessful.

Appendix
7 APPENDIX
7.1 Materials supplied
Material Order No.:
Analyzer 1 x CoaLAB 1000 (405nm) or

1 x CoaLAB 1000 (405/570/740nm) 103-99-020-00
Accessories 1x Distilled Water Container, incl. screw lid --

1x Waste Water Container, incl. screw lid --
1x Distilled Water Sensor --
1x Waste Water Sensor --
1x 12 Filter for Distilled Water Sensor --
1x Syringe 250µl --
1x 10 Cuvette Rings --
1x 11 Sample Cups 4ml --
1x Bottle Washing Solution --
1x Bottle Cleaner --
1x 3 Reducer Rings --
1x USB Stick --
1x Set of fuses (230V) --
1x Set of fuses (115 V) --
1x CD-ROM with Operators Manuals --
1x Packing carton and foam inserts --
7.2 Disposables/Consumables
Material Order number
Cuvette Rings Cuvette Rings, incl. Stir Bars 211-01-097-00

6x10 rings (6x320 measurements)
Sample Cups Sample Cups 4ml 40.000.0063

2x250 Cups
Washing Solution Washing Solution 15ml (thrombin in activator) 30.000.1151

5x15ml bottles
Cleaner Cleaner (pipettor/tubing) 30.000.4002

6x12ml bottles
Teflon Stir bars Stir bars for reagent mixing 30.000.1233

2x13mm
Reducer Rings Reducer rings for reagent vials 5ml 103-97-140-00

1x3 rings
Barcode Scanner 1 x external Barcode Scanner, incl. cable 30.000.1134

Appendix
7.3 Maintenance Kit
Kit consists of: Quantity
Tubings Liquid System Tubing 1
Container Distilled Water Container, incl. screw lid 1

Distilled Waste Container, incl. screw lid 1
Level Sensors Distilled Water Sensor (green) 1

Waste Water Sensor (red) 1
Filters Filter for Distilled Water Sensor 12
Syringe 250µl Syringe 1

Appendix
7.4 Technical Data
General Description
Type of instrument Fully automated coagulation analyzer
Application Coagulation, Chromogenic, Immunologic tests
Working methods Sample oriented

Test selective
STAT (emergency)
Measuring principle Photometric; with magnetic stirrers to homogenize

the test mixture and increase the sensitivity
Light source LED, light emitting diode
Cuvette Volume 150µl - max. 300µl
Test throughput PT 120/h, aPTT 60/h, +/- 20 tests/h
Cuvette volume min. 150 µl, max. 300 µl (test suspension)
Measuring channels Two measuring channels at

- one wavelength 405nm or
- three wavelength 405/570/740nm
Calibration - Manual input of calibration points (max. 7 points),

two calibration curves for each test or
- Automatic calibration
STATS STAT loading is possible at any time in up to three

assigned positions. Routine testing can be interrupted
for STAT loading and then automatically giving
priority to the STAT sample
Analyzer data
Reagent positions 15 positions at room temperature
- (R1-R3) for 15ml reagent vials (left/right pos. stirred)
- (R4-R15) for 5ml reagent vials.
Reagent block can be removed from working area
for external cooling.
Washer positions 2 positions at room temperature

- (W1-W2) for Washer & Cleaner
Calibration/Dilution 8 positions at room temperature

- (C1-C8) for Controls, Calibrators & Dilutions
Sample positions 2x11 positions for primary & secondary tubes/cups

1x3 positions for STAT
Measuring rotor One heated measuring rotor at 37°C +/-0.4°C with

two measuring channels, designed for cuvette rings
Cuvette rings Cuvette ring with 32 cuvettes
Wash Station One wash station for pipettor cleaning
Pipettor Capacitive, movable in three directions (x, y, z),

heated at 37°C

Appendix
Dilutor 250µl syringe

- minimal dosing 2µl
- maximal dosing 250µl
- Resolution: 12 half steps for 1 µl (for 250 µl syringe)
- Level sensors for distilled and waste water container
Rinsing Two modes

- Regular with distilled water
- 4 intensive with washing solution for probe cleaning
(Thrombin inactivator)
Cleaning Cleaning of pumps and tubing with Cleaner
Display Touch sensitive colour display

Visible area: 11.5x8.7cm
Display resolution: 320 x 240 pixels, ¼ VGA).
Software Operating system with Graphic User

Interface (GUI)
Programmable 50 reagents/tests can be freely programmed

Methods
Interfaces 1x USB for external printer device

1x USB for USB Memory device
1x LAN for external PC connection
2x RS 232C serial interfaces
1x external Barcode Scanner connection
Physical data
Voltage: 100 - 240 V
Frequency: 50 - 60 Hz
Capacity: 300 VA
5A/250 V time lag (T5A L250V)
Fuses:
IEC 60127-2/III
Noise emission < 56 dB (A)
Ambient Conditions
Usage: Inner rooms only, dry environment
Altitude: ≤ 2.000 meters
Mains voltage fluctuation: Max. ± 10% of rated voltage
IP Code (IP20): 2 = < 12.5mm, Fingers or similar objects
accord. IEC 60529 0 = Not protected against harmful ingress of water
Pollution degree: Class 1
Temperature: during operation +15°C - +30°C
during transport + 2°C - +50°C
Humidity: 10% - < 85%, non-condensing
Dimensions
Instrument (WxHxD): 78 x 58 x 50 cm 30.7x 22.8 x 19.7 in.
Shipping:
Weight
Instrument: 25 kg 55 lb
Shipping: 30 kg 66 lb

Appendix
7.5 Safety Specifications
This instrument conforms to the appropriate European Directives.

The instrument type described in this manual bears an IVD and CE mark,
IVD which certifies conformity with the requirements of the following European
directives:
Konformitätserklärung / Declaration of Conformity

Declaration de Conformite / Diclaratione de Conformita /Declaración de Conformidad
Wir / We / Nous / Noi / Nosotros
LABiTec
LAbor BioMedical Technologies GmbH
An der Strusbek 6
D-22926 Ahrensburg
erklären in alleiniger Verantwortung, dass / declare on our own responsibility that / déclarons sous notre
propre responsabilité que / dichiarimo sotto propria responsibilitá che / declaramos, bajo nuestra exclusiva
responsabilidad que
das Medizinprodukt / the medical device / le dispositif médical / il dispositivo medico / el producto médico
CoaLAB 1000
Model No.: CL1K-09
allen Anforderungen der Richtlinie 98/79/EG entspricht. / meets all the provisions of the Directive 98/79/EC
which apply to him. / remplit toutes les exigences de la 98/79/CE qui le concernait. / addempie a tutte le
exigenze della Direttiva 98/79/EC che lo riguardano. / corresponde a todas las exigencias de la directiva
98/79/CE.
Angewandte harmonisierte Normen / Applied harmonized standards / Normes harmonisées appliquées /

Norme armonizzate applicate / Aplicar estandares armonizados
EN55011:2007 + A2:2007, EN61326-2-6:2006, EN61000-3-2:2006, EN61000-3-3:1995 +A1:2001 +A2:2005,

EN60601-1-2:2007, EN591
EN61010-1:2001, EN61010-2-101:2002, EN61010-2-081/A1:2003

Appendix
7.6 Mathematics
Computation of PT %
1
(( meas. time-100 % time)/factor)+0.01) = PT %
Range for conversions:
Method Unit from to exceeded
PT: % 2,0 250 error

Ratio --- ---
INR --- 25 error
Fibrinogen: g/l 0,4 9,999 error

mg/dl 40 999,9 error
Another limit is the lag phase of the method.
Extrapolation
PT >100 % linear extrapolation over the last two higher points.
PT <10 % linear extrapolation over the last two lower points.
Fibrinogen: linear extrapolation respectively over the last two points.
Calibration curve axes

PT: reciprocal/linear
Fibrinogen: log/log
Extr. Factor log/log
Intr. Factor log/log
Conversion to ratio
and INR:
RATIO = measured clotting time / normal value
INR = RATIO ISI (International Normalized Ratio)
ISI = International Sensitivity Index according to package insert

Appendix

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Operators Manual

For in-vitro diagnostic use only!

 2008 LABiTec LAbor BioMedical Technologies GmbH. All rights reserved.

1.0 12/16/09 -- Initial version

1.1 04/16/10 V01.01 SW-Update

Exclusions of manufacturers warranty:

• The use of none permitted peripheral devices, e.g. printer.

• Attempted repairs by the customer or third-parties without authorization by manufacturer.

Specifications for Safety

This instrument conforms to the appropriate European Directives.

European Directive: 98/79/EC In-vitro Diagnostic directive.

For further information see chapter 7.5 Safety Specifications

CoaLAB 1000 – Operators Manual 1.1 Page 1

5.2.7 Analyser Status --------------------------------------------------------------------------- 84

CoaLAB 1000 – Operators Manual 1.1 Page 2

CoaLAB 1000 – Operators Manual 1.1 Page 3

Figure 67 STAT Rack 1..3.......................................................................................................................... 67

CoaLAB 1000 – Operators Manual 1.1 Page 4

Figure 136 Calibration Curve Graph .......................................................................................................... 122

CoaLAB 1000 – Operators Manual 1.1 Page 5

The CoaLAB 1000 named hereafter as analyser, is a fully automated photo-

For in-vitro diagnostic use only!

* Depending on the analyser model the system is capable to perform a wide

1.2 Purpose of this instruction manual

Service information is handled separately.

Careful observation of all information, especially of hazards and precautions

1.3 Validity of this instruction manual

All information in this instruction manual refers to this analyser.

CoaLAB 1000 – Operators Manual 1.1 Page 6

2 HAZARD AND PRECAUTIONS

NOTE Read chapter before you attempt to operate the analyser.

2.1 Hazard Warnings and Safety Notices

The cautions and safety regulations in this instruction manual meet

This manual uses different types of symbols to alert you to important

Symbol warns of a risk of injury or of a risk to life (for example by electrical

Symbol warns of a risk of injury or of the instrument being severely

NOTE Symbol introduces rules to be observed.

Use only grounded extension cables.

Never remove protective guards or secured components since you

Electrical connection contacts (plugs, sockets, etc.) can be electrically live.

Even after a device has been switched off, components (e.g.

CoaLAB 1000 – Operators Manual 1.1 Page 7

Unauthorized work on the analyser can lead to the guarantee obligation

This is to be assumed in the following cases:

4. Samples/Reagents Risk of infections

Always follow the manufacturer’s instructions for correct use given in

NOTE Wear safety gloves! There is the risk of infection.

CoaLAB 1000 – Operators Manual 1.1 Page 8

The waste liquid in the waste container must be disposed in compliance

The liquid system tubing’s are not guaranteed to be resistant against

6. Accuracy and precision

7. Cuvette Ring handling

8. Restrictions for samples

CoaLAB 1000 – Operators Manual 1.1 Page 9

10. Barcode Scanner

- Avoid direct eye contact with the laser beam.

670nm LASER DIODE

2.2 Standard Symbols