User Manual Coagulyzer 100: For In-Vitro Diagnostic Use Only!

User Manual
Coagulyzer® 100
For in-vitro diagnostic use only!

Liability Disclaimer
Analyticon Biotechnologies AG 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 Analyticon Biotechnologies AG without notice and without implying any obligation or liability on
the part of the company.
Software Copyrights
All software for the Coagulyzer 100 (in the following Analyzer-Software) is the user and instrument control
Software for the Coagulyzer 100 and is the intellectual property of the initial manufacturer. Intellectual
property rights shall remain with the initial manufacturer. Analyticon Biotechnologies AG is entitled to use the
Analyzer-Software and the printed accompanying material. Any violation of property rights or copyright or
trademark or using conditions may be subject to legal action. The initial manufacturer reserves the rights to
modify the software, hardware and documentation without any prior written notice.
Intellectual Property
Analyticon Biotechnologies AG Coagulyzer 100 is registered trademark of Analyticon Biotechnologies AG.
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 Analyticon Biotechnologies AG in behalf of the initial manufacturer.
Any reference to products, documentation, articles within this publication not expressly described as property
of the initial manufacturer and Analyticon Biotechnologies AG shall be considered as intellectual property of
the publishing company of this certain product, documentation and or article.
Revision History
Analyser
Date
Version Manual Software-Version -
(mm/dd/yy)
Release -
1.0 03/23/11 V1.04 Initial version
Analyticon Biotechnologies AG
Am Mühlenberg 10
35104 Lichtenfels
Germany
Warranty
Analyticon Biotechnologies AG 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.
Analyticon Biotechnologies AG 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 Analyticon Biotechnologies AG is properly notified in writing upon discovery of such
defect.
Analyticon Biotechnologies AG 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 Analyticon Biotechnologies AG set forth above and the obligations and liabilities of
Analyticon Biotechnologies AG 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 Analyticon Biotechnologies AG with respect to merchantability, fitness for
particular purpose and non-infringement). In no event shall Analyticon Biotechnologies AG be liable for
incidental or consequential damages, however, arising and whatever or not occasioned by Analyticon
Biotechnologies AG negligence.
This warranty shall not be extended or altered except by written instrument signed by Analyticon
Biotechnologies AG.
Exclusions of manufacturer’s 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.
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 --------------------------------------------------------------------------------4
1 INTRODUCTION ------------------------------------------------------------------------------8
1.1 Intended use ----------------------------------------------------------------------------------------- 8
1.2 Purpose of this instruction manual ------------------------------------------------------------- 8
1.3 Validity of this instruction manual -------------------------------------------------------------- 8
2 HAZARD AND PRECAUTIONS -----------------------------------------------------------9
2.1 Hazard Warnings and Safety Notices --------------------------------------------------------- 9
2.2 Standard Symbols-------------------------------------------------------------------------------- 12
3 SYSTEM DESCRIPTION ----------------------------------------------------------------- 13
3.1 Analyzer description ----------------------------------------------------------------------------- 13
3.1.1 Touch Screen ----------------------------------------------------------------------------- 14
3.1.2 Working Plate ----------------------------------------------------------------------------- 16
3.1.3 Cuvette Ring Position ------------------------------------------------------------------- 17
3.1.4 Sample Area ------------------------------------------------------------------------------- 18
3.1.5 Dilutor --------------------------------------------------------------------------------------- 19
3.1.6 Pipettor-------------------------------------------------------------------------------------- 20
3.1.7 Rinsing System --------------------------------------------------------------------------- 20
3.1.8 Peripheral equipment and mains connection -------------------------------------- 22
3.2 Software -------------------------------------------------------------------------------------------- 24
3.2.1 Software control via touch screen ---------------------------------------------------- 25
3.2.2 Software Overview ----------------------------------------------------------------------- 30
3.2.3 Program Menus --------------------------------------------------------------------------- 31
3.2.3.1 Main Menu ------------------------------------------------------------------------- 31
3.2.3.2 Setup Menu ------------------------------------------------------------------------ 37
3.3 Measuring Principle ------------------------------------------------------------------------------ 38
3.4 Reagents ------------------------------------------------------------------------------------------- 39
3.5 Load Cuvette Rings to analyzer -------------------------------------------------------------- 40
4 INSTALLATION ----------------------------------------------------------------------------- 44
4.1 General Setup ------------------------------------------------------------------------------------- 44
4.2 Removing the Transport Protections -------------------------------------------------------- 46
4.3 Assembly of the analyzer ----------------------------------------------------------------------- 46
4.3.1 Mount the diluter syringe --------------------------------------------------------------- 46
4.3.2 Connect the Rinsing System ---------------------------------------------------------- 47
4.3.3 Connect an UBS Memory Device ---------------------------------------------------- 49
4.3.4 Connect an external printer ------------------------------------------------------------ 49
4.3.5 Connect a Barcode Scanner (optional) --------------------------------------------- 51
4.3.6 Connect a Personal Computer (RS232C for Service only) -------------------- 51
4.3.7 Connect a HOST Computer (LAN interface) -------------------------------------- 51
5 OPERATION --------------------------------------------------------------------------------- 52
5.1 System Start-up----------------------------------------------------------------------------------- 52
5.1.1 Switch On ---------------------------------------------------------------------------------- 52
5.1.2 System Liquids ---------------------------------------------------------------------------- 55
5.1.3 Fill liquid system and flush system --------------------------------------------------- 55
5.2 Routine Menu ------------------------------------------------------------------------------------- 57
5.2.1 Load/Replace Cuvettes ----------------------------------------------------------------- 57
5.2.2 Load Reagents ---------------------------------------------------------------------------- 59
5.2.3 Load Samples (Routine & STAT) ---------------------------------------------------- 68
5.2.4 Load Controls (QC-Control) ----------------------------------------------------------- 76
5.2.5 Start Measurements (Routine, STAT & Controls) -------------------------------- 80
5.2.6 Show/print results ------------------------------------------------------------------------ 87
Coagulyzer 100 – Operators Manual 1.0 Page 1

CONTENTS
5.2.7 Results Memory -------------------------------------------------------------------------- 89

5.2.7.1 Show/print reaction curves ----------------------------------------------------- 90
5.2.8 Analyzer Status --------------------------------------------------------------------------- 93
5.3 Quality Control (QC Program) ----------------------------------------------------------------- 94
5.3.1 Control Setup ------------------------------------------------------------------------------ 96
5.3.1.1 Define additional QC-Control Parameter ---------------------------------- 100
5.3.2 QC-Periods ------------------------------------------------------------------------------- 106
5.3.2.1 View a QC-Period (statistics) ------------------------------------------------- 107
5.3.2.2 View a QC-Period (chart)------------------------------------------------------ 109
5.3.2.3 Print a QC-Period --------------------------------------------------------------- 111
5.3.2.4 Finish a QC-Period before end of a month-------------------------------- 112
5.3.2.5 Delete a regularly ended QC-Period --------------------------------------- 114
5.3.3 View daily results ------------------------------------------------------------------------ 116
5.3.4 Print all QC-Periods at a time -------------------------------------------------------- 117
5.3.5 Delete all QC-Periods at a time ------------------------------------------------------ 118
5.4 Setup Menu --------------------------------------------------------------------------------------- 121
5.4.1 Im/Export test & reagent parameter via USB-Stick ----------------------------- 122
5.4.1.1 Mount an USB-Stick ------------------------------------------------------------ 122
5.4.1.2 Import data from USB-Stick--------------------------------------------------- 122
5.4.1.3 Export data to USB-Stick ------------------------------------------------------ 125
5.4.2 Select Working Modes ----------------------------------------------------------------- 127
5.4.3 Setup Reagent definition -------------------------------------------------------------- 128
5.4.3.1 Parameter Page 1 --------------------------------------------------------------- 129
5.4.3.2 Parameter Page 2 --------------------------------------------------------------- 132
5.4.4 Setup Test Definition ------------------------------------------------------------------- 136
5.4.4.1 Liquids ----------------------------------------------------------------------------- 138
5.4.4.2 Evaluation ------------------------------------------------------------------------- 140
5.4.4.3 Determination -------------------------------------------------------------------- 146
5.4.4.4 Show Flags (Define Results/Run list) -------------------------------------- 149
5.4.4.5 Define QC-Control Parameter ------------------------------------------------ 150
5.4.5 Calibration --------------------------------------------------------------------------------- 156
5.4.5.1 Edit Calibration for Clotting (manual calibration) ------------------------ 158
st
5.4.5.2 Edit Calibration for Kinetic / Diff. / 1 deri (manual calibration) ------ 165
5.4.5.3 Auto Calibration for Clotting (automated calibration) ------------------- 171
5.4.6 Delete Results --------------------------------------------------------------------------- 188
5.4.7 Setup Language ------------------------------------------------------------------------- 189
5.4.8 Setup Date & Time ---------------------------------------------------------------------- 190
5.4.9 Change Password ---------------------------------------------------------------------- 191
5.4.10 Setup Beeper ----------------------------------------------------------------------------- 192
5.4.11 Setup STAT Autoprint ------------------------------------------------------------------ 193
5.4.12 Define Headline -------------------------------------------------------------------------- 193
5.4.13 Initiate Analyzer Selftest --------------------------------------------------------------- 194
5.5 Switch off analyzer ------------------------------------------------------------------------------ 196
6 SAFETY IN OPERATION --------------------------------------------------------------- 197
6.1 Maintenance and Hygiene -------------------------------------------------------------------- 197
6.1.1 Maintenance frequency ---------------------------------------------------------------- 198
6.1.2 Cleaning of the housing---------------------------------------------------------------- 199
6.1.3 Clean Pipettor ---------------------------------------------------------------------------- 199
6.1.4 Clean Containers/Sensors Replace Filter ----------------------------------------- 200
6.1.5 Perform cleaning cycle ----------------------------------------------------------------- 200
6.1.6 Perform washing cycle ----------------------------------------------------------------- 202
6.1.7 Protocol of Maintenance Check ----------------------------------------------------- 203

CONTENTS
6.1.8 How to dispose of used disposables ----------------------------------------------- 203

6.1.9 Disposal of the Analyzer --------------------------------------------------------------- 203
6.2 Troubleshooting --------------------------------------------------------------------------------- 204
6.2.1 Application errors ------------------------------------------------------------------------ 204
6.2.2 Error Flags in the Results/Run or Results/Memory List ------------------------ 205
6.2.3 Errors during operation ---------------------------------------------------------------- 205
6.2.4 How to change fuses ------------------------------------------------------------------- 209
7 APPENDIX---------------------------------------------------------------------------------- 210
7.1 Materials supplied ------------------------------------------------------------------------------- 210
7.2 Disposables/Consumables -------------------------------------------------------------------- 210
7.3 Maintenance Kit --------------------------------------------------------------------------------- 211
7.4 Technical Data ----------------------------------------------------------------------------------- 212
7.5 Safety Specifications --------------------------------------------------------------------------- 214
7.6 Mathematics -------------------------------------------------------------------------------------- 215

LIST OF FIGURES
LIST OF FIGURES
Figure 1 Coagulyzer 100 system ............................................................................................................. 13
Figure 2 Touch Screen............................................................................................................................. 14
Figure 3 Reagent Area ............................................................................................................................. 16
Figure 4 Measuring Rotor ........................................................................................................................ 17
Figure 5 Cuvette Ring .............................................................................................................................. 17
Figure 6 Sample Area............................................................................................................................... 18
Figure 7 Dilutor Module ............................................................................................................................ 19
Figure 8 Pipettor ....................................................................................................................................... 20
Figure 9 Container and level sensors for distilled water (green) and waste water (red) .............................. 20
Figure 10 Rinsing System........................................................................................................................... 21
Figure 11 External interfaces (rear view) ................................................................................................... 23
Figure 12 Main Menu functions .................................................................................................................. 25
Figure 13 Area frame, scroll buttons, select window .................................................................................. 26
Figure 14 Select box, Check Box ............................................................................................................... 27
Figure 15 Movable Window........................................................................................................................ 28
Figure 16 Movable Window (Graph) .......................................................................................................... 29
Figure 17 Message Box ............................................................................................................................. 29
Figure 18 MAIN MENU .............................................................................................................................. 31
Figure 19 Run Preparation ......................................................................................................................... 32
Figure 20 Required Reagents .................................................................................................................... 33
Figure 21 Short form Results ..................................................................................................................... 34
Figure 22 Result Selection ......................................................................................................................... 35
Figure 23 Result/Memory ........................................................................................................................... 35
Figure 24 Status Menu ............................................................................................................................... 36
Figure 25 Setup Menu................................................................................................................................ 37
Figure 26 Measuring Principle ................................................................................................................... 38
Figure 27 CuvCARD/ChipCARD Reader ................................................................................................... 41
Figure 28 Message: Load CuvCARD ......................................................................................................... 41
Figure 29 Message: Overwrite loaded balance .......................................................................................... 42
Figure 30 Message: No C-Rings loaded .................................................................................................... 42
Figure 31 Message: Overview of loaded C-Rings ...................................................................................... 43
Figure 32 Carry analyzer............................................................................................................................ 44
Figure 33 Mount of Syringe in Dilutor V1 .............................................. Fehler! Textmarke nicht definiert.
Figure 34 Mount of Syringe in Dilutor V2 ................................................................................................... 46
Figure 35 Connect the level sensor tubes to the analyzer ......................................................................... 48
Figure 36 Container for distilled water. Container and tubes are coded green. ......................................... 48
Figure 37 Container for waste water. Container and tubes are coded red. ................................................ 49
Figure 38 USB-Stick Interface.................................................................................................................... 49
Figure 39 Status Line with active print ....................................................................................................... 50
Figure 40 Analyzer Status Message .......................................................................................................... 52
Figure 41 Message: Insert Cuvette Ring .................................................................................................... 53
Figure 42 Pump Test ................................................................................................................................. 53
Figure 43 Pump Test failed ........................................................................................................................ 54
Figure 44 Pump Test OK ........................................................................................................................... 54
Figure 45 MAIN MENU .............................................................................................................................. 55
Figure 46 Run Preparation Menu ............................................................................................................... 56
Figure 47 Load C-Ring ............................................................................................................................... 57
Figure 48 Remaining C-Ring balance ........................................................................................................ 58
Figure 49 Load Reagents........................................................................................................................... 59
Figure 50 Test Select List .......................................................................................................................... 59
Figure 51 Reagent/Washer Table .............................................................................................................. 60
Figure 52 Renew all reagents .................................................................................................................... 61
Figure 53 Load Reagents........................................................................................................................... 61
Figure 54 Tools in Load Reagents ............................................................................................................. 62
Figure 55 Vials Menu ................................................................................................................................. 63
Figure 56 Vials Menu Example: PT ............................................................................................................ 63
Figure 57 Message: Renew Reagent ......................................................................................................... 64
Figure 58 Change reagent position ............................................................................................................ 64
Figure 59 Target Position ........................................................................................................................... 65
Figure 60 Change vial size......................................................................................................................... 65
Figure 61 Tools in Vials Menu .................................................................................................................... 66
Figure 62 Exit Load Reagents Menu .......................................................................................................... 67
Figure 63 Load Samples ............................................................................................................................ 68
Figure 64 Edit Sample ID ........................................................................................................................... 68
Figure 65 Entered Sample ID..................................................................................................................... 69
Figure 66 Sample/STAT Positions ............................................................................................................. 70
Figure 67 Sample Rack 1..11..................................................................................................................... 70
Figure 68 Sample Rack 12..22................................................................................................................... 71

LIST OF FIGURES
Figure 69 STAT Rack 1..3.......................................................................................................................... 71

Figure 70 Vial Frame ................................................................................................................................. 72
Figure 71 Sample with assigned vials ........................................................................................................ 73
Figure 72 Select test/assay ........................................................................................................................ 73
Figure 73 Clone Mode................................................................................................................................ 74
Figure 74 Tools in Load Samples .............................................................................................................. 74
Figure 76 Load Controls............................................................................................................................. 76
Figure 77 Control Positions ........................................................................................................................ 77
Figure 78 Vial Frame ................................................................................................................................. 77
Figure 79 Select test/assay ........................................................................................................................ 78
Figure 80 Tools in Load Samples .............................................................................................................. 79
Figure 82 Menu Measurement ................................................................................................................... 80
Figure 83 Tools in Measurement Menu ..................................................................................................... 81
Figure 84 Running Measurement............................................................................................................... 81
Figure 85 Prepare STAT run ...................................................................................................................... 82
Figure 86 Load STAT Samples .................................................................................................................. 82
Figure 87 Warning Message before STAT ................................................................................................. 83
Figure 88 Load STAT Samples .................................................................................................................. 83
Figure 89 Status Window ........................................................................................................................... 84
Figure 90 Immediate STOP ....................................................................................................................... 84
Figure 91 Warning user interrupt ............................................................................................................... 85
Figure 92 Pending Measurements ............................................................................................................. 85
Figure 93 Short Form Results .................................................................................................................... 86
Figure 94 Tools in Running Measurement Screen ..................................................................................... 86
Figure 95 Results/Run ............................................................................................................................... 87
Figure 96 Results/Memory 1 ...................................................................................................................... 89
Figure 97 Results/Memory 2 ...................................................................................................................... 90
Figure 98 Curve Input ................................................................................................................................ 90
Figure 99 Curve Input keyboard................................................................................................................. 90
Figure 100 Tools in Results/Memory ........................................................................................................... 91
Figure 101 Reaction Curves ........................................................................................................................ 91
Figure 102 Tools in Reaction Curve Diagram .............................................................................................. 92
Figure 103 Status Menu ............................................................................................................................... 93
Figure 104 QC Main Page ........................................................................................................................... 95
Figure 105 Select Control Position ............................................................................................................... 96
Figure 106 Define Control Plasma ............................................................................................................... 97
Figure 107 Edit Control Plasma ................................................................................................................... 98
Figure 108 Delete Control Plasma ............................................................................................................... 98
Figure 109 QC Main Page ........................................................................................................................... 99
Figure 110 Main Menu ................................................................................................................................. 99
Figure 111 Setup Menu.............................................................................................................................. 100
Figure 112 Select Test Screen................................................................................................................... 100
Figure 113 Test Menu Main Page .............................................................................................................. 101
Figure 114 Test Menu Select Control ........................................................................................................ 101
Figure 115 Test Menu QC.......................................................................................................................... 102
Figure 116 Test Menu Select Control List .................................................................................................. 103
Figure 117 Test Menu selected Control ..................................................................................................... 103
Figure 118 Test Menu Main Screen ........................................................................................................... 104
Figure 119 Tools in Test Menu Main Page ................................................................................................ 105
Figure 120 QC Main Page ......................................................................................................................... 106
Figure 121 Select active QC-Period List .................................................................................................... 106
Figure 122 QC Result Table ...................................................................................................................... 107
Figure 123 QC-Period overview 1 .............................................................................................................. 108
Figure 124 QC-Period overview 2 .............................................................................................................. 108
Figure 125 Levey-Jennings Chart .............................................................................................................. 109
Figure 126 Tools in Edit Reagent Page 1 .................................................................................................. 110
Figure 127 Print QC-Period........................................................................................................................ 111
Figure 128 Tools in QC Main-Page ............................................................................................................ 111
Figure 129 Finishing QC-Period................................................................................................................. 112
Figure 130 Info Box printed QC-Period ...................................................................................................... 112
Figure 131 Delete QC-Period..................................................................................................................... 113
Figure 132 Deleted QC-Period Info............................................................................................................ 113
Figure 133 Print/Finish Info ........................................................................................................................ 114
Figure 134 QC-Result Functions ................................................................................................................ 115
Figure 135 Delete QC-Period..................................................................................................................... 115
Figure 136 Deleted QC-Period confirmation .............................................................................................. 116
Figure 137 Daily results table..................................................................................................................... 116

LIST OF FIGURES

Figure 139 Print all QC-Periods ................................................................................................................. 117
Figure 140 Printing all QC-Periods ............................................................................................................ 118
Figure 142 Delete all QC-Periods 1 ........................................................................................................... 119
Figure 143 Delete all QC-Periods 2 ........................................................................................................... 119
Figure 145 Delete QC file........................................................................................................................... 120
Figure 147 Stop System............................................................................................................................. 122
Figure 148 Im/Export Test & Reagent Parameters .................................................................................... 123
Figure 149 Import Test & Reagent Parameters ......................................................................................... 123
Figure 150 Importing Parameters .............................................................................................................. 124
Figure 151 Parameter Import OK ............................................................................................................... 124
Figure 152 Im/Export Test & Reagent Parameters .................................................................................... 125
Figure 153 Export Test & Reagent Parameters ......................................................................................... 126
Figure 154 Remove USB-Stick .................................................................................................................. 126
Figure 155 Mounting another USB-Stick .................................................................................................... 126
Figure 156 Setup Working Modes .............................................................................................................. 127
Figure 157 Select Reagent Screen ............................................................................................................ 128
Figure 158 Edit Reagent Main Screen ....................................................................................................... 129
Figure 159 Edit Reagent Page 1 ................................................................................................................ 129
Figure 161 Edit Reagent Main Screen ....................................................................................................... 131
Figure 162 Edit Reagent Page 2 ................................................................................................................ 132
Figure 164 Tools in Edit Reagents Main Screen ........................................................................................ 135
Figure 165 Select Test Screen................................................................................................................... 136
Figure 167 Test Menu Liquids.................................................................................................................... 138
Figure 168 Tools in Test Menu Liquids ...................................................................................................... 139
Figure 169 Test Menu Evaluation .............................................................................................................. 140
Figure 170 Test Menu Tech Clotting .......................................................................................................... 141
Figure 171 Test Menu Evaluation/Kinetic................................................................................................... 143
Figure 172 Test Menu Tech Kinetic ........................................................................................................... 144
Figure 173 Test Menu Evaluation/Kinetic................................................................................................... 145
Figure 175 Test Menu Determin. ............................................................................................................... 146
Figure 176 Test Menu Misc. Smoothing .................................................................................................... 148
Figure 178 Test Menu Show-Flags ............................................................................................................ 149
Figure 180 Test Menu Select Control ........................................................................................................ 151
Figure 181 Test Menu QC.......................................................................................................................... 151
Figure 182 Test Menu Select Control List .................................................................................................. 152
Figure 183 Test Menu selected Control ..................................................................................................... 153
Figure 184 Test Menu Main Screen ........................................................................................................... 154
Figure 185 Tools in Test Menu Main Page ................................................................................................ 154
Figure 187 Select test Calibration .............................................................................................................. 157
Figure 188 Calibration Menu Main Page .................................................................................................... 157
Figure 189 Calibration Menu Clotting ......................................................................................................... 158
st
Figure 191 Calibration Values 1 evaluation .............................................................................................. 161
Figure 192 Calibration Curve Graph .......................................................................................................... 163
Figure 193 Tools in Calibration Graph Screen ........................................................................................... 164
st
Figure 195 Calibration Menu Kin/Diff/1 deri ............................................................................................. 165
nd
Figure 197 Calibration Values 2 evaluation ............................................................................................. 168
Figure 198 Tools in Calibration Value Screen ............................................................................................ 169
Figure 200 Select test Calibration .............................................................................................................. 171
Figure 202 Calibration Menu Clotting ......................................................................................................... 173
Figure 204 Calibration Values (concentration) ........................................................................................... 175
Figure 206 Control & Calibrator Positions C1-C8....................................................................................... 178

LIST OF FIGURES
Figure 207 Place Calibrator Position 1 ....................................................................................................... 179

Figure 208 Reagent Status List Calibration................................................................................................ 179
Figure 209 Tools in Calibration Measurement Menu ................................................................................. 180
Figure 210 Running Measurement Calibration........................................................................................... 181
Figure 211 Tools in Calibration Measurement Menu ................................................................................. 181
Figure 212 Reaction Curves Calibration .................................................................................................... 182
Figure 213 Running Measurement Calibration........................................................................................... 182
Figure 214 Results/Run List Calibration ..................................................................................................... 183
Figure 215 Warning Message Calibration .................................................................................................. 183
Figure 216 Warning Message Measuring Status ....................................................................................... 184
Figure 217 Auto Calibration finished .......................................................................................................... 184
Figure 219 Calibration data ........................................................................................................................ 185
Figure 220 Calibration Curve ..................................................................................................................... 186
Figure 221 Tools in Calibration Graph Screen ........................................................................................... 186
Figure 222 Delete Results.......................................................................................................................... 188
Figure 223 Delete Results Message Box ................................................................................................... 188
Figure 224 Setup Language....................................................................................................................... 189
Figure 225 Select Language ...................................................................................................................... 189
Figure 226 Setup Date & Time................................................................................................................... 190
Figure 227 Date & Time Settings ............................................................................................................... 190
Figure 228 Change Password.................................................................................................................... 191
Figure 229 Setup Password ....................................................................................................................... 191
Figure 230 Setup Beeper ........................................................................................................................... 192
Figure 231 Setup STAT autoprint .............................................................................................................. 193
Figure 232 Define Headline ....................................................................................................................... 193
Figure 233 Selftest ..................................................................................................................................... 194
Figure 234 Selftest Transmission ............................................................................................................... 194
Figure 235 Selftest finished........................................................................................................................ 195
Figure 237 Shutdown Analyzer .................................................................................................................. 196
Figure 238 Shutdown Selection ................................................................................................................. 196
Figure 239 Perform Cleaning Cycle ........................................................................................................... 201
Figure 240 Perform Washing Cycle ........................................................................................................... 202
Figure 241 Change fuses, voltage selector ................................................................................................ 209

INTRODUCTION
1 INTRODUCTION
This chapter provides a global introduction to the Coagulyzer 100 system. It
is recommended to read this chapter first.
Read this manual carefully before you attempt to operate the

Coagulyzer 100 system.
1.1 Intended use
The Coagulyzer 100 named hereafter as analyzer, 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 analyzer 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 analyzer
types.
However; the manual will indicate any difference between the available
model types if required.
The analyzer 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 analyzer 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 analyzer.
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 analyzer.

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.
Read this chapter before you attempt to operate the analyzer.
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).
Symbol warns of a risk of injury or of the instrument being severely

damaged.
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
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 analyzer 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.
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 analyzer
operation. Moving parts (fan, motor drives and 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,
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.
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 analyzers Washing Solution has an open vial stability of 7 days at 20°C
to 30°C.
For cleaning the system waste tubing and pipettor the correct analyzer
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 the Cleaner at room temperature.
5. Waste Liquids
The waste liquid in the waste container must be disposed in compliance
with applicable regulations.
The liquid waste of the analyzer 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 analyzer Cleaner only.
6. Accuracy and precision

of the measured results
In order to ensure a flawless operation of the analyzer measure control
samples and/or standards and watch the function of the instrument closely.
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 analyzer performs an automatic cuvette
recognition check.
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 new cuvette rings 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
mixers! Use cuvettes and mixers only once! Prior of each measurement
ensure a mixer is added to each cuvette.
9. User qualification
The analyzer should only be operated by trained personnel. Ask you local
dealer or distributor for further information on the availability of user
trainings.

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.
- Ensure the scanner was tested and authorized for use by the
manufacturer.
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 Important Information
Recyclable Corrosive
Electric Shock Warning Biological Risk
Fuse This side up
Separate collection, handling and

Switch off Analyzer 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 analyzer description, its components and

provides detailed information on how to unpack and install the analyzer the
first time.
3.1 Analyzer description
The analyzer represents a new the state of the art development and is a
microprocessor-controlled, two-channel photo-optical fully automated blood
plasma hemostasis analyzer. The analyzer is a modular construction.
Figure 1 Coagulyzer 100 system
1- Pipettor
2- Safety Shield
3- ChipCARD Reading Unit
4- Sample Positions
5- STAT Positions
6- Touch sensitive colour display
7- Measuring / Cuvette Ring Rotor
8- Cup Array for Sample Cups (Controls/Calibrators)
9- Reagent Block (removable)
10 - Rinsing Station
11 - Washer / Cleaner Position
12 - USB Stick Interface (underneath)
13 - Dilutor & Syringe 250µl

SYSTEM DESCRIPTION
Handling of safety shield:
It is recommended to always close the safety shield during analyser

operation to avoid injuries and damage of moving parts. Open the
safety shield only when the analyzer is not in operation.
The safety shield must be opened all the way to the top.
3.1.1 Touch Screen

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
the control panel as it might cause irreparable damage to the control
panel surface.
Figure 2 Touch Screen

SYSTEM DESCRIPTION
Function and Navigation Keys
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
ESC& 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 analyzer 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 analyzer 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.
Figure 4 Measuring Rotor
Figure 5 Cuvette Ring

SYSTEM DESCRIPTION
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
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 analyzer 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 IDs can be introduced to the analyser using an external

barcode scanner. To read how to connect and operate a barcode
scanner, see chapter 4.3.5 Connect a Barcode Scanner (optional) and
5.2.3 Load Samples.
3.1.5 Dilutor
The analyzer 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 analyzer
The distilled water container is marked with a green label, whereas the waste
container is marked with a red label.
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.
Figure 10 Rinsing System
Besides the rinsing solution the analyzer 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 analyzer.
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 analyzer is equipped with several interfaces.
Using these interfaces the analyzer 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 analyzer or stored by on an USB memory device.
The backplane of the analyzer carries the mains supply connection. The
instrument is designed for mains supply voltages between 100V and 240V,
at 50/60Hz.
The analyzer 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

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
2
0.75 mm . 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)
1- Waste Water (Connection for Level Sensor red)
2- Dist. Water (Connection for Level Sensor green)
3- DC BC-Scanner (Power connection external Barcode Scanner)
4- Extern. BC-Scanner (Serial interface Barcode Scanner)
5- LAN Interface
6- USB Printer (External printer interface)
7- 2x RS 232C interfaces (Com 1 / Com 2)

Power Filter, contains:
- Fuse holder
8-
- Power Switch I = ON, O = OFF
- Mains Connection

SYSTEM DESCRIPTION
3.2 Software
The operating system software interface allows the user to operate the
analyzer as an independent measuring instrument without any peripheral
equipment.
The analyzer software is stored in a ROM and is started after the instrument
is switched on. It controls the analyzer through the start-up initialization and
controls all functions for analyzer setup and the analysis programme.
Some analyzer 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 5.4.9
Change Password.
User Interface
The dialogue between analyzer and user takes place via the built-in touch
screen; refer also to chapter 3.1.1 Touch Screen
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
the control panel as it might cause irreparable damage to the control
panel surface.
To operate the analyzer 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, analyzer information and
to view graphics.
The following pages provide further information on available menus,

software areas, functions and defines the functionality of the analyzer
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 press onto

the check box field.
2- Check Box
OFF= no set 
ON = set 

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.

SYSTEM DESCRIPTION
3.2.2 Software Overview

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 analyzer
software. See chapter 5.2 Routine Menu and 5.4 Setup Menu for an
accurate description of the detailed software functions.
3.2.3.1 Main Menu

The Main Menu automatically appears after the analyzer has been switched
ON and the initialization process of all analyzer 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
analyzer setup, reagent and test definition,
Setup Area
quality control (only available if software is
installed) 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 Analyzer 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.
Displays the controls load window, positioning of

Load Controls
controls and selection of control 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 and/or controls to be

Samples+Controls
measured, fully 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. To
define the result information shown in this window; see chapter 5.4.4.4
Show Flags (Define Results/Run list).
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 analyzer status concerning
temperatures of rotor and pipettor, Container Status,
Display cuvette ring information, irregularities in the results
Information measured, QC information as well as other errors
appeared during measurement. Any problems
occurring may be marked coloured.
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 5.4.9 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 analyzer 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
analyzer.
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
Selection of different available languages for user
Language Anyone
interface
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 analyzer.
Headline Defines print headline Anyone
Tools Access to other functions Anyone
OK Return to MAIN MENU Anyone

SYSTEM DESCRIPTION
3.3 Measuring Principle
The analyzer 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 analyzer.
The measuring module consists of a two channel LED photometer with

wavelengths of 405nm/570nm/740nm, attached to the measuring rotor.
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. The signal is converted into a digital
value which is transformed to the Extinction value.
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 Analyticon`s

adapted line of reagents, controls and buffers. 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

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.
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

analyzer, 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.

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
To guarantee safe, correct and precise coagulation analysis the

manufacturer has executed extensive trials and studies concerning the
analyzer 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.
The analyzers are equipped with a cuvette management system, which

allows loading of a cuvette ring credit balance of original cuvette rings to the
analyzer, by means of a cuvette card, so-called CuvCARD. The individually
loaded cuvette ring credit balance enables the analyzer to perform
coagulation measurements in the same quantity of cuvette rings as loaded
on the analyzer.
At first delivery the analyser is preloaded with a cuvette ring balance

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 analyzer, 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 analyzer.
Once the cuvette ring credit balance is fully used, i.e. when measurements
of the quantity of the loaded cuvette ring balance have been performed, the
analyzer 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,

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
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 analyzer.
 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 analyzer.
 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 analyzer 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

analyser, the remaining balance eventually still on the analyser will be
overwritten. Make sure the balance on the analyser is fully used prior
to 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 analyzer.
The analyzer 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 analyzer 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

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

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
analyzer for use.
Before performing any tasks in this chapter, review the Hazard and
Precautions listed in chapter 2 of this manual.
4.1 General Setup
Remove the analyzer 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.
When carrying the analyzer take care of the USB interface and dilutor
located at the right side of the analyzer.
Figure 32 Carry analyzer
 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 analyzer having free
access to the interface panel and power switch in the rear of the analyzer
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!

INSTALLATION
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.
 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 to avoid premature formation of algae in the
tubing system.
 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

main switch at all times. In case of any emergency, it may be
Ensure there necessary to immediately switch off the analyser.
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
later use, including the transport protection devices. Store them
away from heat and humidity.

INSTALLATION
4.2 Removing the Transport

Protections
The analyzer is secured with several transport protection parts to avoid any
damage of the analyzer or components during its transportation.
Prior of use the analyzer 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 Y-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 Z-
direction.
4. Empty red cuvette ring in the measuring rotor to protect from
contamination of the measuring cells.
4.3 Assembly of the analyzer
Before connecting the analyzer 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:

Dilutor version 2
 Fill in distilled water in the syringe
 Unscrew the black piston holder coverage
 Push down the piston holder with two fingers (instrument is powered off).
 Insert the syringe with the piston in the holder.
 Screw the cylinder into the diluter valve.
 Take care the syringe is free of air and completely filled with DI water
 Attach the piston holder coverage
Figure 33 Mount of Syringe in Dilutor V2

INSTALLATION
4.3.2 Connect the Rinsing System

The analyzer is equipped with two water containers (distilled water and
waste water). All containers should be located to the left side, behind the
analyzer. The distilled water temperature may not exceed the specified
temperature of the analyzer (+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 analyzer.
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.
The system must be switched OFF.

INSTALLATION
Figure 34 Connect the level sensor tubes to the analyzer
The distilled water container must have at least 1 Liter of distilled

water. The waste water container should be emptied every day. Be
careful not to have air bubbles in the distilled water container as
welll as in the tube. The distilled water container may not be placed
in direct sunlight.
Container
Figure 35 Container for distilled water. Container and tubes are coded green.

INSTALLATION
Figure 36 Container for waste water. Container and tubes are coded red.
4.3.3 Connect an UBS Memory Device

The analyzer is equipped with two USB interfaces. While one USB interface
is located at the rear side of the analyzer utilized for connecting an external
printing device the second USB interface can be found at the right side of
the analyzer; see figure below.
Figure 37 USB-Stick Interface
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
analyzer. To record measuring data first insert a USB Stick into the USB
interface located as shown in the figure above. Leave the USB Stick in the
interface, the USB Stick will me mounted once the analyzer is switched on.
The USB Stick should have a memory of at least 1GB.
4.3.4 Connect an external printer

The analyzer offers the possibility for connecting an external USB printer
device using the USB interface at the rear side of the analyzer; 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 analyzer to connect the printer to the analyzer.
 Connect the power supply plug to the printer.
 The analyzer will automatically detect the USB printer once connected
to the analyzer. To verify the connection is set correctly the symbol print
in the status line of the analyzer must turn green.
Recommended printer types / interface parameter settings:

INSTALLATION
Interface Manufacturer Type/model

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

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

INSTALLATION
4.3.5 Connect a Barcode Scanner

(optional)
 Connect the optional barcode scanner to the analyzer. Use the
recommended type only.
 Connect the barcode scanner data cable to the RS232C socket (marked
Extern. BC-Scanner) on the analyzer (see figure 11 No.3/4).
 Plug the power supply into the socket (marked DC BC-Scanner) next to
it.
4.3.6 Connect a Personal Computer

(RS232C for Service only)
The analyzer is equipped with two serial RS 232C interface ports on the
rear side of the analyzer.
The RS 232C interfaces are specified as follows:
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 analyzer and to the interface port of your computer.
4.3.7 Connect a HOST Computer

(LAN interface)
Additionally the analyzer disposes of a LAN (Local Access Network)
interface on the rear side of the analyzer which is supposed to be used for
connecting external PC and HOST Systems for data transfer.
The LAN interface can be used as follows:
Uni-Directional: To transfer analyzer parameters and patient results to a

connected Personal Computer or HOST System.
Bi-Directional: To receive sample joblists from a HOST computer and to

transfer patient results and parameter setting to a
connected HOST or Personal Computer. The Bi-
Directional HOST communication requires additional
software available to the system. Please contact the
manufacturer or your local distributor to get more
information on the software and how to set up a HOST
communication.

OPERATION
5 OPERATION
This chapter provides a step-by-step introduction to routine operation of the
analyzer.
Before performing any tasks in this chapter, review the Hazard and
Precautions listed in chapter 2 of this manual.
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 analyzer.
5.1.1 Switch On
Set the power switch on the back side of the analyzer to the position I = ON,
see also figure 11.
The analyzer now runs through a full initialization procedure checking all
internal modules automatically. The following describes the sequence of the
initialization procedure:
Figure 39 Analyzer Status Message
Above window provides information about the number of wavelength

available in this analyzer model, customer ID and analyzer software installed
as well as the release date.
In case the system still carries a cuvette ring in the measuring rotor the
following box appears. This message indicates the number of used cuvettes
in the cuvette ring.

OPERATION
Figure 40 Message: Insert 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.
During the initialization procedure the analyzer beside other modules also
checks the status of the liquid system, meaning the function of the DI pump,
waste pump and level detection.
Figure 41 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 analyzer 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:

OPERATION
Figure 42 Pump Test failed
By pressing the button OK the analyzer 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 analyzer 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.
After successful pump and level detection test the following message
appears:
Figure 43 Pump Test OK
Once the initialization process is finished the MAIN MENU appears in the
display.

OPERATION
Figure 44 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 Connect the Rinsing System
 Place the two level sensors in the containers making sure that the colour
of each level sensor matches its corresponding container.
5.1.3 Fill liquid system and flush system

For transport safety reasons the analyzer has been delivered in dry
condition, meaning without any system liquids. Before using the analyzer 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
that they are watertight.
 From the Main Menu, press the button Run Preparation the following
display appears.

OPERATION
Figure 45 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

analyzer 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 to use 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 analyzer 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 analyzer 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 46 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 analyzer, see chapter 3.5 Load Cuvette Rings
to analyzer.
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.
Figure 47 Remaining C-Ring balance
Each load of a new cuvette ring will deduct one ring from the loaded
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 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 48 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 49 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
Reagent Position section, see example APTT.
Figure 50 Reagent/Washer Table
The Reagent Position Table is an exact reflection from the reagent area of
the analyzer. It assigns the positions to where the reagents have to be
placed on the analyzers, see chapter 3.1.2 Working Plate.
 Place the reagents in the assigned position on the analyzer

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
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 analyzer! 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 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
Renew all loaded reagents and

washers
 By pressing the button renew all all loaded reagents and washers will
be renewed and the stability timer re-starts. The following window
appears:
Figure 51 Renew all reagents
By pressing the button YES renew all procedure will be started once the
load reagent screen (Safe&Exit) is being pressed.
By pressing the button No renew all procedure won´t be started.
 Confirm this message box by pressing Yes or No according to the

corresponding action, the following window appears:
Tools
Figure 52 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 53 Tools in Load Reagents
The following Tools are available:
Available Tools Description

By pressing this button the vial menu screen will
Hardcopy be printed out, provided a printer is connected
to the analyzer.
By pressing this button the vial menu opens
vials allowing change of reagent positions and vial
sizes.
By pressing this button you will leave this

Quit
window without any changes.
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.

OPERATION
Change reagent positions and

vial size (vials button)
 By pressing the vials button the following window appears:
Figure 54 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 55 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 56 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
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 57 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 58 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
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 59 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 60 Tools in Vials Menu

OPERATION

Quit
By pressing this button you will be asked to

ESC confirm whether all changes done in the vial
menu shall be confirmed or waived.
By pressing this button the vial menu screen will
to the analyzer.
Save&Exit (Vials Menu) By pressing the Save&Exit button all changes in the Vial Menu will be
confirmed and returns back to the Load Reagents Menu.
Figure 61 Exit Load Reagents Menu
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 62 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 63 Edit Sample ID

OPERATION
 Use the keyboard to enter the sample/patient ID required, see chapter

3.1.1 Touch Screen for further information. For sample/patient ID entry
15 alphanumeric characters are available.
When entering a sample/patient ID certain characters are not allowed

to be used since these may create conflicts when transmitted to a
connected HOST computer later on. The following characters are
permitted to be used if samples/patient results are entered:
ABCDEFGHIJKLMNOPQRSTUVWXYZabcdefghijklmnopqrstuvwxyz012
3456789!%&()[]{}=#~+-,^@
Avoid spaces between symbols, words & numbers.
 Press the Enter button once the sample/patient ID is entered.
Figure 64 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 Connect a
Barcode Scanner (optional).
 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.

OPERATION
A large number of barcodes can be used. If the system does not

accept a certain barcode contact the manufacturer or enter the patient
ID manually.
 Repeat described steps to enter more samples.
Select Sample Rack The analyzer 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 65 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 66 Sample Rack 1..11

OPERATION
Figure 67 Sample Rack 12..22
Figure 68 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 69 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
sample area as selected in the vial frame. Only one type can be
selected at a time. 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 same coloured
dot beside the sample will appear on all samples.
Figure 70 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 if 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 71 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 is now copied to the sample (02). Press
again the Clone mode button to deactivate.
Figure 72 Clone Mode
The Clone mode will only copy the test/assay information to another
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 73 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 analyzer.
Get request By pressing this button the analyzer verifies
(Only available with Bi- whether there is a sample request provided by a
Directional HOST software) connected HOST.

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:
 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 Load Controls (QC-

Control)
This chapter describes how to load and measure control plasmas inside a
quality control period. To proceed with this section requires previous
definition and setup of control plasma, see chapter 5.3 Quality Control (QC
Program).
The following information is important prior processing a quality control run:
 Up to 8 controls can be defined and placed into positions C1 to C8, see

chapter 3.1.2 Working Plate, Reagent Area.
 The names and positions of the controls can not be changed in this
menu, see chapter 5.3.1 Control Setup.
 Up to 3 controls out of max. 8 can be assigned to a test at a time, see
chapter 5.3.1.1 Define additional QC-Control Parameter.
 Control Plasmas already assigned to a test and part of an active QC-
Period cannot be modified before QC-Period is finished and printed, see
chapter
 Once a control is assigned to a test, the control period automatically
starts.
To load controls proceed as follows:
Run Preparation Menu.
and/or
 From the Run Preparation Menu, press the button Load Controls the
Figure 75 Load Controls
Within this menu the complete control plasma handling can be controlled
and set. It further provides information on currently loaded controls, controls
to load, selectable control cups/tubes and reagents available for each
control.
 Select a control by pressing onto the control button once, e.g. (Control
1). The control box will be highlighted.
 The number shown on the left side of the selected control indicates the
predefined position (C3) where the vial/tube must be placed in the
reagent area.

OPERATION
Figure 76 Control Positions
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 Analyzer uses the

controls/calibrator positions (C1-C8).
Select Control Vial A selection of two secondary tubes/vials may be assigned to each control.
 Select a vial/tube from the list as shown in the vial frame of the display,
see next figure.
Figure 77 Vial Frame
Below table shows the vials/tubes placeable in the control area. Based on
the vial/tube used select the corresponding colour in the vial frame of the
display.

OPERATION
The Control Positions accommodate the following vials/tubes:
Hitachi 2ml Secondary
Make sure to place the same sized (coloured) vial/tube into the
control area as selected in the vial frame. Only one type can be
selected at a time. Otherwise you risk failure in your analysis or
damage of the pipettor.
Renew The accuracy and precision of control plasma depends on its stability time.
To define the stability time, see chapter 5.3.1 Control Setup.
Press the renew button to re-start the defined stability time but ensure the
control used is still inside this stability.
Assign test(s) to a control To assign tests (assays) to a control you may select out of the tests/assays
as listed in the Load Controls Menu. Within this list all tests/assays will be
shown as previously loaded, see chapter 5.2.2 Load Reagents.
 Select the test/assay from the list as shown on the right side of the
display, see figure below example PT by pressing onto the test/assay
buttons.
Figure 78 Select test/assay
 Selected tests/assays will be highlighted. Repeat this procedure for all

controls you intent to assign tests/assays for.
Tools The Tools button in the Load Control Menu offers several options and

OPERATION
Figure 79 Tools in Load Samples

Timeline of the joblist entered in a diagram and provides
run time information.
By pressing this button the current screen will
to the analyzer.

Quit
Pressing this button will erase all control

Erase Jobl.
information (Joblist) of the selected control.
Show Jobl. Opens and shows the joblist currently entered.
OK Pressing the OK button in the Load Control Menu confirms all changes in
this menu. The following display appears:

OPERATION
In the Run Preparation Menu press OK again to return back to the MAIN
MENU. You are now prepared to start the control measurements.
5.2.5 Start Measurements

(Routine, STAT & Controls)
 From the Main Menu, press the button Measurement to access the
Measurement Menu.
Figure 81 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/controls
loaded:
- Number of loaded samples/controls
Samples & Controls
- Number of samples/controls to be processed
- Number of samples/controls partially
processed
Tools The Tools button in the Measurement Menu offers several options and

OPERATION
Figure 82 Tools in Measurement Menu
By pressing this button the screen will be printed,

Hardcopy
provided a printer is connected to the analyzer.
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.
The analyzer 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 83 Running Measurement

OPERATION
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 84 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
runs press the No button.
Press the Yes button to initiate a STAT run the following window appears:
Figure 85 Load STAT Samples

OPERATION
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 86 Warning Message before STAT
Confirm this message and the following by pressing the OK button until next
window appears:
Figure 87 Load STAT Samples
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 5.2.5 Start Measurements.

OPERATION
Status The Status button provides access to an information window, see figure
below. For further information on the Status button see chapter 5.2.8
Analyzer Status.
Figure 88 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 89 Immediate STOP

OPERATION
Figure 90 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 91 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:

OPERATION
Figure 92 Short Form Results
The following procedure is performed after a run is finished.
resend Press the resend button to send results to a HOST computer. Only possible
if an active connection to a HOST PC is available.
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.
 Press the Tools button to access further additional areas. The following
Figure 93 Tools in Running Measurement Screen

OPERATION
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.
5.2.6 Show/print results

 From the Main Menu, press the Results/Run button to access the short
form result list.
Figure 94 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.

OPERATION
The following failure codes are available:
Error Flags Description
State: OK The measurement has been finished with no problems.
No clot detection:
State: none No clot has been found within the set measuring time
and valid clotting range.
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:
State: F A photometer error was detected during a
measurement.
Liquid Error:
State: L
Not enough reagent or sample available during the run.
QC Error:
A test under Quality Control must be measured within
the last 24 hours using the assigned control plasma
State: Q
before a routine measurement can be done. Additionally
this test may not be in violation to the Westgard-Rules.
The Q Error will appear in case these requirements are
not fulfilled.
resend To resend the short form results to a HOST computer press the resend
button. Make sure a HOST computer is connected to the analyzer, prior
starting to send results, see chapter 4.3.7 Connect a HOST Computer
(LAN interface).
Print To print the short form result list press the Print button. Make sure a printer
is connected to the analyzer, prior starting a print-out, see chapter 4.3.4
Connect an external printer.
OK Press the OK button to return to MAIN MENU.

OPERATION
5.2.7 Results Memory

 From the Main Menu, press the button Results/Memory to access the
result memory of the analyzer.
Figure 95 Results/Memory 1
 From the Main Menu, press the button Results/Memory to access the
result memory of the analyzer.
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
5.2.7.1 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 96 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 97 Curve Input
 Press into an input field to open the keyboard entry. The following
window appears.
Figure 98 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 99 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 100 Reaction Curves

OPERATION
Tools The Tools button in the reaction curve diagram window offers additional
Figure 101 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
5.2.8 Analyzer Status

At any time the analyzer offers information on the current status of the
system. Depending on the current state of the analyzer the Status button
may turn into different colours in case any problem occurs.
 From the Main Menu, press the button Status to access the Status
Menu.
Figure 102 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, the state of motors as well as information on any QC related
information, memory allocation and displays any irregularities and errors
which may appear during a run.
The Status button displays the following states of the analyzer:
A green Status button means that no particular problems have been

discovered which could in any way cause problems to the analyzer
hardware, measurements, QC Status and memory space available.
However, problems can still occur, e.g. requests of tests with invalid
calibration.
An orange Status button means that there is a general problem or other

information available, e.g. reminder to run the daily quality control or a
limited number of cuvette ring balance available. In general measuring
series are not affected.
A red Status button means that measuring series cannot start or have been
stopped due to an error.
The Status window can be moved in all directing by touching onto the
screen with your finger tip.
 Additionally this status information can be printed by pressing the Print

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

OPERATION
5.3 Quality Control (QC Program)
Laboratory quality control (QC) is designed to detect, reduce, and correct

deficiencies in a laboratory's internal analytical process prior to the release
of patient results and improve the quality of the results reported by the
laboratory. Quality control is a measure of precision or how well the
measurement system reproduces the same result over time and under
varying operating conditions. Laboratory quality control material is usually
run at the beginning of each shift; after an instrument is serviced; when
reagent lots are changed; after calibration, and when patient results seem
inappropriate.
For such control measurements either specific control plasmas or patient

plasmas will be used. Interpretation of quality control data involves both
graphical and statistical methods. Quality control data is visualized using a
Levey-Jennings Chart. The dates of analyses are plotted along the X-axis
and control values are plotted on the Y-axis. The distance from the mean is
measured in one, two, and three standard deviations (SD). The mean and
also the standard deviations are marked on the Y-axis. Inspecting the
pattern of plotted points provides a simple way to detect increased random
error and shifts or trends in calibration.
The formulation of Westgard Rules is used to analyse data in the statistical

control charts. These rules can be applied to see whether the results from
the samples when the control was done can be released, or if they need to
be rerun. Westgard Rules are used to define specific performance limits for
a particular assay and can be used to detect both random and systematic
errors. Westgard Rules are programmed in to analyzers software to
determine when an analytical run should be rejected. These rules need to be
applied carefully so that true errors are detected while false rejections are
minimized.
The QC program can only be fully accessed by authorized users in the

expert level, see chapter 3.2 Software. Without access to this level only
limited areas of the QC program can be used.
To set up controls and a QC-Period for a specific test the following must be
considered:
 Up to 8 controls can be defined

 Up to 3 different controls can be assigned to a test at a time
 Each control assigned to a test is analyzed separately for the control
period
 A QC-Period is limited to a calendar month
 Within a QC-Period days without results are allowed
 The day change time is fixed at 12:00pm (midnight)
 Controls are loaded to the 8 control positions C1 to C8, see chapter
3.1.2 Working Plate, Reagent Area.
 A control measurement will be handled on a higher priority in the run
than a stat measurement
 A control result is treated like a sample within a run but control
measurements are always measured at first in a run.
 Control measurements run in single determination only.
 If a test is set to Auto-repeat the control measurement uses the
measuring time for Auto-repeat, see chapter 5.4.4.2 Evaluation, Auto-
repeat but the control measurement won‟t be repeated automatically.
 If a control measurement for a test is run a second time a day the
previous measured QC result will be overruled by the newest control
result available.

OPERATION
 If converted results are set to calculate control results the test used for
this control measurement must have a valid calibration, see chapter
5.4.5 Calibration.
A calibration is not possible if reagents are not set to calibrate, see

section Reagent Setup/Page 1 / Calibrate (check box) in chapter
5.4.3.1 Parameter Page 1.
 From the Main Menu, press the button QC to access the Quality Control
Program. The following window appears:
Figure 103 QC Main Page
The QC Main Page allows you to define whether the QC Program shall be
activated, how to setup controls, view running QC-Periods, statistics and
graphs and daily results measured as well as to define specific evaluation
rules according to Westguard regulations and to print/finish and delete QC-
Periods.
Quality Control on By using this check box button you may define or modify whether the QC
Program will be set to on or off. Set individual parameters On/Off by pressing
onto the field, e.g. ON (QC Control on) = .
During an active running QC period the QC Program cannot be set

to off. Finish and print the running QC-Period first before
deactivating the the QC Program.

OPERATION
Westguard Rules The check box buttons in the Westgard Rules frame allow you to define and
select the available Westgard Rules regulations.
By using this check box button you may define or modify whether certain
rules will be set to on or off. Set individual parameters On/Off by pressing
onto the field, e.g. ON (1_3S on) = .
The following Westgard Rules are available:
Rules Description
Refers to a control rule that is commonly used with a Levey-
Jennings Chart when the control limits are set as the mean
13s plus 3s and the mean minus 3s. A run is rejected when a
single control measurement exceeds the mean plus 3s or the
mean minus 3s control limit.
A run is rejected when 2 consecutive control measurements
22s exceed the same mean plus 2s or the same mean minus 2s
control limit.
A run is rejected when 1 control measurement in a group
R4s exceeds the mean plus 2s and another exceeds the mean
minus 2s.
41s exceed the same mean plus 1s or the same mean minus 1s
control limit.

8x
fall on one side of the mean
5.3.1 Control Setup

From the QC Main Page Screen press the Control Setup button to define
or modify the control plasma.
Figure 104 Select Control Position

OPERATION
Until no Controls are defined, the position buttons remain empty. By

pressing onto the blue field you define the position to place the Control
Plasma on the analyzer. There are up to 8 positions on board available.
Position C1&C2 can also be used for Control Plasma. Please

consider that these positions are also used for diluents/calibrators
required for calibration. The use of positions C1 and C2 for controls
and calibrators requires the cups to be replaced manually. To avoid
errors it is recommended to use positions C3-C8 for control plasmas
only.
To define or modify a Control Plasma select the position and press the
suitable button, e.g. Pos 3.
Figure 105 Define Control Plasma
Name By pressing into the Name input field a keypad opens allowing the entry or
modification of the name of a control plasma. The control plasma name may
have up to 15 alphanumerical characters. E.g. Control1
Abbrev. By pressing into the Abbrev. (abbreviation) input field a keypad opens
allowing the entry or modification of the abbreviation of a control plasma
name. The control plasma abbreviation may have up to 5 alphanumerical
characters. This abbreviation is used in other menu screens for identification
of the control plasma. E.g. Con1
Lot-No. By pressing into the Lot-No. input field a keypad opens allowing the entry
or modification of the lot number of a control plasma. The lot number may
have up to 15 alphanumerical characters, e.g. ABC1234
A new lot number can only be used if a control plasma is not

assigned to a running QC-Period.
Stability By pressing into the Stability input field a keypad opens allowing the entry
or modification of the stability time of a control plasma. The stability time
may have up to 2 numerical characters. Input range: 1 - 99 (h).

OPERATION
Figure 106 Edit Control Plasma
Delete By pressing the Delete button in the Edit Control Plasma Page will delete
the Control Plasma setup.
A Control Plasma can not be deleted if assigned to a running QC-

Period. The QC-Period must be finished and printed first.
Figure 107 Delete Control Plasma
Pressing the Yes button will delete the Control Plasma setup. No will keep
the entry as previously done.
Tools The Tools button in the Edit Control Plasma Screen offer several options
and access to other menus and actions.

OPERATION

Quit
ESC&Exit By pressing the ESC&Exit button you will leave the Edit Control Plasma
Screen without saving the previous done changes and modifications.
Save&Exit Pressing the Save&Exit button in the Edit Control Plasma Screen confirms
all changes and modifications done.
Proceed the same way as described in this chapter if you intent to setup or
modify additional Control Plasmas.
After pressing the Save&Exit button you will return back to the QC Main
Page.
OK Press the OK button to return back to the Main Menu.
Figure 109 Main Menu

OPERATION
5.3.1.1 Define additional QC-Control Parameter
This section describes how assign previously defined Control Plasma to a

test and how to enter additional QC-Control Parameter required for result
calculation and statistical/graphical evaluation.
 From the Main Menu Screen press the Setup button.
 In the Setup Menu press the Test Setup button.
Figure 111 Select Test Screen
The Select Test Screen contains a list of all tests saved.
 To select a test for quality control definition use the arrow keys to first
select the test and then press the OK button to continue.

OPERATION
The following example provides description on how to define a PT test.

Proceed the same way if you intent to assign other test for quality control
definition.
 In the Select Test Screen chose PT and confirm by pressing the OK

button.
Figure 112 Test Menu Main Page
 To assign control plasmas and or modify or add parameters and result

calculations press the QC button.
Figure 113 Test Menu Select Control
Up to three different Control Plasmas can be assigned individually to a test.

By pressing onto the individual buttons you enter into the QC Control
parameter page. Repeat the procedure for each Control Plasma to be added
to the test as described as follows.

OPERATION
Figure 114 Test Menu QC
Select result type By pressing the Select Box arrow buttons you can select between 6 different
type of results, meaning whether the QC result calculation will be based on
raw values or converted values.
Converted values can only be selected and memorized if the test is

subject to a calibration and has a valid calibration, see chapter 5.4.5
Calibration. Otherwise only result types are selectable which are
applicable to the test selected.
The following result types are available:
Available result types Description

Sets the result calculation to clotting, raw values
Clotting
will be calculated in [sec].
st Sets the result calculation to clotting conversion,
Clotting 1 conversion st
1 conversion values will be calculated in [%].
nd Sets the result calculation to clotting conversion,
Clotting 2 Conversion nd
2 conversion values will be calculated in [INR].
Sets the evaluation algorithm to Kinetic,
st
st Difference or 1 Derivation (depending on test
Kinetic/Difference/1
setup), raw values will be calculated in [mE/s]
derivation raw
for Kinetic, [mE] for Difference, [Delta mE/sec]
st
for 1 derivation.
st st
Kinetic/Difference/1 Difference or 1 Derivation (depending on test
derivation conversion setup), converted values will be calculated in
the unit defined in calibration setup.
Sets the evaluation algorithm to the maximum
st
Max. Time time of the measuring signal in 1 Derivation
mode. Values will be calculated in [sec]
Off No result calculation
Control Plasma By pressing onto the blue field a window opens allowing you to select
Control Plasma from a list of previously defined Controls, see chapter 5.3.1
Control Setup
The following window appears.

OPERATION
Figure 115 Test Menu Select Control List
The Select Control Plasma Screen contains a list of all previous Controls
memorized. A total of 8 Controls can be defined and memorized.
 To select a Control use the arrow keys to first select the Control Plasma
and then presses the OK button to continue.
The selected Control Plasma appears in the following window:
Figure 116 Test Menu selected Control
Target value By pressing into the Target value input field a numerical keypad opens
allowing the entry or modification of the target value expected to be
achieved from the control plasma and test measurement. Depending on the
test and result type selected the target value must be entered either as raw
value, e.g. in seconds or as converted value, e.g. % (PT).
1S-deviation By pressing into the 1S-deviation input field a numerical keypad opens
allowing the entry or modification of the 1 sigma deviation based on the
target value entry. Input Range: ≥5% and ≤ 20% of the target value in
seconds.
Example:
Target Value = 12 sec.
1S-Deviation = min. 0.6 sec. / max. 2.3 sec.
Based on the 1S-deviation entry the ±1S, ±2S and ±3S thresholds are
calculated.
OPERATION
1S-deviation definition:
 The single standard deviation corresponds to the ± 1S Range

 The double standard deviation corresponds to the ± 2S Range
 Three times the standard deviation corresponds to the ± 3S Range.
Delete By pressing the Delete button in the Test Menu QC Screen your will delete
the parameter setting and remove the Control Plasma from the test setup
specifications.
Control Plasma cannot be deleted if Control Plasma is used in an

active QC-Period. Active QC-Periods must be finished and printed
first.
Tools The Tools button in the Test Menu QC Screen offers additional options and

Quit
OK Press the OK button to return back to the Test Menu Main Screen.
Figure 117 Test Menu Main Screen
Tools
The Tools button in the Test Menu Main Screen offer several options and

OPERATION
Figure 118 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 analyzer.
ESC&Exit By pressing the ESC&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.
All necessary information to start a quality control period has now been
entered into the system. To load controls and run a QC measurement,
proceed as described in chapter, load controls.
To view daily results, statistical information and show graphical information

(Levey Jennings Chart) or get further information on how to print, finish and
delete QC-Period proceed with the next chapter.

OPERATION
5.3.2 QC-Periods
The following section describes how to view all available quality control data
such as graphical and statistical of a running QC-Period.
 From the Main Menu Screen press the QC button to enter the QC Main
Page.
 From the QC Main Page press the QC-Periods button.
Figure 120 Select active QC-Period List
The following overview shows all currently active QC-Periods of the actual
year and month and related Test and assigned control.
 To select a specific QC-Period use the arrow keys to move up and down
the screen. The selected QC-Period will be highlighted. Press the OK
button to view further information.

OPERATION
Figure 121 QC Result Table
From the QC-Result Table you can select out of a variation of available
information related to the selected QC-Period.
The following is available:
Available Information Description

By pressing this button the selected QC-Period
will be deleted. However, a QC-Period must
Delete
always be finished and printed first prior deletion
otherwise this action will not be allowed.
Shows the statistical calculations, results and
Table predefined setup information for this specific QC
test and control combination.
Shows the graphical information (Levey-
Chart Jennings Chart) for this specific QC test and
control combination.

Quit
Pressing this button will automatically finish and

Finish
print a selected QC-Period.
Pressing this button will print the current

Print available results and charts of a selected QC-
Period.
5.3.2.1 View a QC-Period (statistics)
 By pressing the Table button you will enter into the statistical overview
of the selected QC-Period.
The following overview shows all currently available information related to

the selected QC-Period.

OPERATION
Figure 122 QC-Period overview 1
The statistical QC-Results and Setting list provides information on the

current settings of a selected QC-Period, the test and control assigned to
this QC-Period as well as status information and currently done
measurements, standard deviations and mean values. It further provides
information on the Status of a QC-Period, meaning whether it has been
printed or finished already.
The window can be moved by touching the finger tip onto the screen and
moving it to all sides or additionally by using the arrows (up/down, left/right)
available.
Print By pressing the Print button will initiate a print-out of this list.
OK By pressing the OK button you will leave this window and enter into an
additional table providing further information on each result measured during
this QC-Period and Westgard-Rules violations according to the selected
rules for this QC-period.
Figure 123 QC-Period overview 2
Print By pressing the Print button will initiate a print-out of this list.
OK By pressing the OK button you will return to the QC-Result Table.

OPERATION
5.3.2.2 View a QC-Period (chart)
 By pressing the Chart button you will enter into the chart overview of the
selected QC-Period.
This menu command calls up the graphic display of the results of the
selected QC-Period in a Levey-Jennings Chart.
Figure 124 Levey-Jennings Chart
The selected QC-period is displayed as a Levey-Jennings Chart.
X-Axis:
The X-Axis comprises a maximum of 31 days so that the complete month
can be displayed. The respective date is shown on the X-Axis in the format
Day of Month. In the upper line of the chart the respective year and month
are displayed including the test and control used.
Y-Axis:
The Y-Axis is scaled so that all results can be displayed. The result range is
either displayed as raw value in (sec.) or as converted value, e.g. mg/dl
depending on the Control Setup, see chapter 5.3.1 Control Setup. The
following labelled horizontal lines are displayed:
Red line + 3s / -3s:

Three times the standard deviation of the mean value (target value) as
entered in chapter 5.3.1.1 Define additional QC-Control Parameter.
Orange line + 2s / -2s:

Two times the standard deviation of the mean value (target value) as
entered in chapter 5.3.1.1 Define additional QC-Control Parameter.
Yellow line + 1s / -1s:

Upper and lower limit of the confidence range for accuracy controls, see
chapter 5.3.1.1 Define additional QC-Control Parameter, 1S-Deviation.
Green Line norm:

Nominal value as entered in Target Value, see chapter 5.3.1.1 Define
additional QC-Control Parameter.
/:
QC-Results are above or below the + 3s / -3s deviation.

OPERATION
Tools The Tools button in the Levey-Jennings Chart window offers additional
Figure 125 Tools in Edit Reagent Page 1

Quit
Performs a print of the Levey-Jennings Chart

Hardcopy
screen only.
OK By pressing the OK button you will return to the QC-Result Table.

OPERATION
5.3.2.3 Print a QC-Period

A QC-Period can be printed including all current available information
related to this QC-Period. If a QC-Period has been printed the period will be
assigned with the status printed in the statistic settings and result list, see
chapter 5.3.2.1 View a QC-Period (statistics).
Figure 126 Print QC-Period
 By pressing the Print button in the QC-Result Table you will start
printing the selected QC-Period.
Keep the print-out of all QC-Periods at a safe place as they are the
final document of the quality control done. After printing and
finishing a QC-Period all QC-Results will be deleted from the system
and won’t be available for later use.
Once the QC-Period is printed you will return back to the QC-Result Table.
Figure 127 Tools in QC Main-Page

OPERATION
5.3.2.4 Finish a QC-Period before

end of a month
A regular QC-Period is limited to a calendar month. QC-Periods regularly
end at the last day of the month and will be finished automatically the first
day of the following month (at 0:00) if no user interaction took place.
However, a selected QC-Period can be finished before end of a month if
requested.
 By pressing the Finish button you will start finishing a current running
QC-Period.
Figure 128 Finishing QC-Period
 By pressing No you will leave this window and return back to the QC-
Result Table. Press Yes to finish the QC-Period selected. In case the
QC-Period has not been printed until date an automated print-out of the
complete QC-Period (statistics/charts) starts. Otherwise the following
display appears:
Figure 129 Info Box printed QC-Period
 Confirm this message by pressing the OK button.

OPERATION
Figure 130 Delete QC-Period
Check again the print-out available for this particular QC-Period to ensure
adequate documentation of your QC-Period results.
 By pressing No the QC-Period will be continued. Press Yes to finally

confirm the QC-Period to be finished and deleted.
Figure 131 Deleted QC-Period Info

OPERATION
5.3.2.5 Delete a regularly ended

QC-Period
A QC-Period which regularly ends after the end of a month will be finished
automatically on the first day of the following month and kept in the result file
storage unless the decision has been made to delete finally from the
system. To delete such QC-Periods follow the instructions as follows:
Once a QC-Period is deleted all results and charts related to this QC-
Period are deleted from the system.
 To delete a regularly ended QC-Period press the QC button in the Main

Menu to enter the QC Main Page.
 In the QC Main Page press the QC-Periods button and select a QC-
Period out of the QC-Period list. Press OK to access the QC-Result
Table window.
 By pressing the Delete button in the QC-Result Table you will start the
deletion process for the selected QC-Period.
The following display appears if the selected QC-Period has neither been
printed nor finished yet:
Figure 132 Print/Finish Info
 Confirm message by pressing the OK button. Follow the description as

provided in chapter 5.3.2.3 Print a QC-Period, 5.3.2.4 Finish a QC-
Period before end of a month before proceeding with the deletion of
the selected QC-Period.
If the QC-Period ended regularly it will be automatically finished the first day
of the following month.
 To finally delete a regularly ended QC-Period press the QC button in the

Main Menu to enter the QC Main Page.
 In the QC Main Page press the QC-Periods button and select a QC-
Period out of the QC-Period list. Press OK to access the QC-Result
Table window.

OPERATION
Figure 133 QC-Result Functions
Above window shows the QC-Period selected has been finished

automatically by the system as the Finish button is not available for use.
However, before being able to delete the selected QC-Period it is necessary
to print first.
 Press the Print button to start printing the QC-Period. Make sure a
printer is up and connected to the analyzer and enough paper is
available for the print-out.
As soon as the print-out is done the QC-Period can be deleted from the
system.
Press the Delete button in the QC-Result Table and the following display
appears:
Figure 134 Delete QC-Period
Confirm above message by pressing either Yes to delete the selected QC-
Period or No if you intent not to delete the selected QC-Period. By pressing
Yes the following window appears.

OPERATION
Figure 135 Deleted QC-Period confirmation
Keep the print-out of all QC-Periods at a safe place as they are the
final document of the quality control done. After printing and
finishing a QC-Period all QC-Results will be deleted from the system
and won’t be available for later use.
5.3.3 View daily results

This menu in the QC Main Page allows you to view the current QC results of
the day.
Page.
 By pressing the Daily Results button the following display appears:
Figure 136 Daily results table
 From the Daily Result List press either the Print button to print the table
for your records or the OK button to return back to the QC Main Page
window.

OPERATION
5.3.4 Print all QC-Periods at a time

This menu in the QC Main Page allows you to print all available QC-Periods
at a time.
Page.
 From the QC Main Page press the Print button in the All QC-Periods
frame. Make sure a printer is up and connected to the analyzer and
enough paper is available for the print-out.
Figure 138 Print all QC-Periods
Confirm above message by pressing either Yes to print all finished QC-
Periods or No if you intent not to print. By pressing Yes the following window
appears.

OPERATION
Figure 139 Printing all QC-Periods
5.3.5 Delete all QC-Periods at a time

This menu in the QC Main Page allows you to delete all available already
printed and finished QC-Periods at a time.
Page.
 From the QC Main Page press the Delete button in the All QC-Periods
frame. Make sure all QC-Periods are printed and finished first.

OPERATION
Figure 141 Delete all QC-Periods 1
Confirm above message by pressing either Yes to delete all finished and
printed QC-Periods or No if you intent not to delete. By pressing Yes the
following window appears.
Figure 142 Delete all QC-Periods 2
It is necessary to confirm deletion of all QC-Periods separately. Confirm by

pressing the Yes button, No will cancel this decision. The following display
appears:

OPERATION
Now all available QC-Periods have been deleted from the system. To finally
delete the QC file used press again the QC-Periods button in the QC Main
Page and confirm the following QC-Periods select window with OK.
The following message appears:
Figure 144 Delete QC file
Confirm above message by pressing either Yes to delete the QC-data file or
No if you intent not to delete.
All available QC-data has now been successfully removed from the system.

SAFETY IN OPERATION
5.4 Setup Menu
The Setup Menu allows you to define all operational analyzer, 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 analyzer 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
analyzer.
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
Selection of different available languages for user
Language Anyone
interface
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

SAFETY IN OPERATION
5.4.1 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.
5.4.1.1 Mount 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 analyzer 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 146 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 analyzer. Switch off
analyzer by setting power switch to position O = OFF.
 After switching off the analyzer add the USB-Stick to the USB interface
located at the right side of the analyzer; see Figure 37 USB-
Stick Interface.
 Re-start the analyzer again by setting the power switch to position I =

ON and follow the initialization sequence of the analyzer. The USB-Stick
has now been mounted by the system software.
5.4.1.2 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.

SAFETY IN 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 147 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 analyzer to the
USB-Stick.
By pressing this button you will start the import
Import sequence to load data from the USB-Stick to the
analyzer.
 Press Import to load test and reagent parameters from the USB-Stick to
the analyzer.
Figure 148 Import Test & Reagent Parameters

SAFETY IN OPERATION
By importing test and reagent parameters to the analyser all current

available parameters on the analyser will be overwritten. Export
such data first to the USB-Stick in case you want to safe the current
system parameters, see chapter 5.4.1.3 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 149 Importing Parameters
Figure 150 Parameter Import OK
 Once the import sequence is finished confirm by pressing the OK

button. The parameters have successfully being brought to the
analyzer.
 Back in the Setup Menu press the OK button to get back to the Main
Menu.
 Shutdown the system, refer to chapter 5.4.1.1 Mount 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.

SAFETY IN OPERATION
5.4.1.3 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 5.4.1.1 Mount 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 151 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 analyzer to the
USB-Stick.
By pressing this button you will start the import
Import sequence to load data from the USB-Stick to the
analyzer.
 Press the button Export to transfer test and reagent parameters from
the analyzer to the USB-Stick.

SAFETY IN OPERATION
Figure 152 Export Test & Reagent Parameters
Figure 153 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 analyzer. By pressing Yes the following
window appears.
Figure 154 Mounting another USB-Stick

SAFETY IN 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.
5.4.2 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 155 Setup Working Modes

SAFETY IN OPERATION
5.4.3 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 156 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.

SAFETY IN OPERATION
Figure 157 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.
5.4.3.1 Parameter Page 1

By pressing the Page 1 button the following window opens:
Figure 158 Edit Reagent Page 1
Within this screen the following general reagent data can be defined or
modified:

SAFETY IN 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
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 a reagent
requires calibration, see chapter 5.4.5 Calibration. Set individual
parameters On/Off by pressing onto the field, ON = .
Once a reagent is set to calibrate all tests using this reagent must be
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.

SAFETY IN OPERATION
The difference between Cycle time and Cycle Pause results to the
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

Quit
OK Press the OK button to return back to the Edit Reagent Main Screen.
Figure 160 Edit Reagent Main Screen

SAFETY IN OPERATION
5.4.3.2 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 161 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
analyzer.
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
manufacturer!

SAFETY IN 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
analyzer.
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
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.

SAFETY IN 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: 2 - 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

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

SAFETY IN OPERATION
Tools
Tools button in the Edit Reagent Main Screen offer several options and
Figure 163 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 analyzer.
ESC&Exit By pressing the ESC&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.

SAFETY IN OPERATION
5.4.4 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 164 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.

SAFETY IN OPERATION
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 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:

st
- 1 Evaluation
nd
Evaluation - 2 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.
To assign certain control plasma parameters to
defined controls, such as:
- Type of result
QC
- Control Plasma
- Target value in seconds
- 1S-Deviation

SAFETY IN OPERATION
5.4.4.1 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 166 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 field, e.g. ON (Sample Start set) = .
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 volumes 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).

SAFETY IN 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
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 167 Tools in Test Menu Liquids

Quit

SAFETY IN OPERATION
5.4.4.2 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 168 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
5.4.5.1 Edit Calibration for Clotting (manual
calibration).
No evaluation method is set. No calibration
st
off parameters can be assigned to tests using 1
evaluation.
After setting the evaluation method to clotting [sec.] an additional button

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

SAFETY IN OPERATION
Figure 169 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 5.4.5.1 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 field, e.g. ON =  (Auto-repeat active).
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
5.4.4.2 Evaluation / Measuring Time.
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”.

SAFETY IN 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
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.

SAFETY IN OPERATION
Figure 170 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
nd
2 evaluation.
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 5.4.5.2
Sets the evaluation method to Difference and

the Tech button.
Difference [mE]
entered if difference is selected, see chapter
5.4.5.2
Sets the evaluation method to 1st derivation and

the Tech button.
1st derivation [mE/s]
st
entered if 1 derivation is selected, see chapter
5.4.5.2
After setting the evaluation method to Kinetic [mE/min], Difference [mE]

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

SAFETY IN OPERATION
Figure 171 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 derivation [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 field, e.g. ON =  (rising
values set).

SAFETY IN 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 172 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 analyzer model the following wavelength are available:
 405 nm
 570 nm
 740 nm

SAFETY IN 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
5.4.4.3 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 174 Test Menu Determin.

SAFETY IN 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: 1 - 20 (%).
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 Derivation,
1st derivation [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 [%].

SAFETY 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 5.4.4.2 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 175 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

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

SAFETY IN OPERATION

Quit
5.4.4.4 Show Flags (Define Results/Run list)

Within this section you may define the contents respectively results to be
shown in the Results per run list, see chapter 5.2.6 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 177 Test Menu Show-Flags

SAFETY IN OPERATION
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. The availability of the result flags depends on the
st nd
selection done in 1 and 2 evaluation.
Set individual parameters On/Off by pressing onto the field, ON =  (active).
Tools The Tools button in the Test Menu Show-Flags Screen offers additional

Quit
5.4.4.5 Define QC-Control Parameter
Within this section you may assign up to three control plasmas to the
selected test if part of a Quality Control Period. See also chapter 5.3
Quality Control (QC Program).
 From the Test Menu Main Screen press the QC button to assign control
plasmas and or modify the parameters and result calculations.

SAFETY IN OPERATION
Figure 179 Test Menu Select Control
Up to three different Control Plasmas can be assigned individually to a test.

By pressing onto the individual buttons you enter into the QC Control
parameter page. Repeat the procedure for each Control Plasma to be
added to the test as described as follows.
Figure 180 Test Menu QC
Select result type By pressing the Select Box arrow buttons you can select between 6 different
types of results, meaning whether the QC result calculation will be based on
raw values or converted values.
Converted values can only be selected and memorized if the test is

subject to a calibration and has a valid calibration, see chapter 5.4.5
Calibration. Otherwise only result types are selectable which are
applicable to the test selected.

SAFETY IN OPERATION
The following result types are available:
Available result types Description

Sets the result calculation to clotting, raw values
Clotting
will be calculated in [sec].
st Sets the result calculation to clotting conversion,
Clotting 1 conversion st
1 conversion values will be calculated in [%].
nd Sets the result calculation to clotting conversion,
Clotting 2 Conversion nd
2 conversion values will be calculated in [INR].
st
st Difference or 1 Derivation (depending on test
Kinetic/Difference/1
setup), raw values will be calculated in [mE/s]
derivation raw
for Kinetic, [mE] for Difference, [Delta mE/sec]
st
for 1 derivation.
st st
Kinetic/Difference/1 Difference or 1 Derivation (depending on test
derivation conversion setup), converted values will be calculated in
the unit defined in calibration setup.
Sets the evaluation algorithm to the maximum
st
Max. Time time of the measuring signal in 1 Derivation
mode. Values will be calculated in [sec]
Off No result calculation
Control Plasma By pressing onto the blue field a window opens allowing you to select
Control Plasma from a list of previously defined Controls, see 5.3.1 Control
Setup.
The following window appears.
Figure 181 Test Menu Select Control List
The Select Control Plasma Screen contains a list of all previous Controls
memorized. A total of 8 Controls can be defined and memorized, refer to
chapter 5.3.1 Control Setup to define Control Plasmas and start a QC
period.
 To select a Control use the arrow keys to first select the Control Plasma
and then presses the OK button to continue.

SAFETY IN OPERATION
The selected Control Plasma appears in the following window:
Figure 182 Test Menu selected Control
Target value By pressing into the Target value input field a numerical keypad opens
allowing the entry or modification of the target value expected to be
achieved from the control plasma and test measurement. Depending on the
test and result type selected the target value must be entered either as raw
value, e.g. in seconds or as converted value, e.g. % (PT).
1S-deviation By pressing into the 1S-deviation input field a numerical keypad opens
allowing the entry or modification of the 1 sigma deviation based on the
target value entry. Input Range: ≤5% and ≥20% of the target value.
Example:
Target Value = 12 sec.
1S-Deviation = min. 0.6 sec. / max. 2.3 sec.
Based on the 1S-deviation entry the ±1S, ±2S and ±3S thresholds are
calculated.
1S-deviation definition:
 The single standard deviation corresponds to the ± 1S Range
 The double standard deviation corresponds to the ± 2S Range
 Three times the standard deviation corresponds to the ± 3S Range.
Delete By pressing the Delete button in the Test Menu QC Screen your will delete
the parameter setting and remove the Control Plasma from the test setup
specifications.
Control Plasma cannot be deleted if Control Plasma is used in an

active QC-Period. Active QC-Periods must be finished and printed
first.
Tools The Tools button in the Test Menu QC Screen offers additional options and

SAFETY IN OPERATION

Quit
Figure 183 Test Menu Main Screen
Tools
The Tools button in the Test Menu Main Screen offer several options and
Figure 184 Tools in Test Menu Main Page

SAFETY IN OPERATION

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
ESC&Exit By pressing the ESC&Exit button you will leave the Test Menu without
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

SAFETY IN OPERATION
5.4.5 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:

st nd
If the evaluation mode for 1 and 2 evaluation is not set to OFF, refer
to chapter 5.4.4.2 Evaluation.
 A Lot Number was added or changed in a reagent set to calibrate, see

chapter 5.4.3.1 Parameter Page 1.
 If reagent parameters are changed using a reagent set to calibrate, see

chapter 5.4.3.1 Parameter Page 1.
A calibration is not possible if reagents are not set to calibrate, see

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

SAFETY IN OPERATION
Figure 186 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 187 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:

SAFETY IN 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 derivation defined unit/activity.
1st deri.: Converts raw value [mE/sec.] into a

Before selecting the calibration mode in this screen the

corresponding evaluation mode must be assigned to the test first,
see chapter 5.4.4.2 Evaluation to assign the 1st and or 2nd
evaluation to a test also defining whether the test allows entry of 2
calibration curve parameters.
5.4.5.1 Edit Calibration for Clotting

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

st
for tests based on clotting or to define parameters for a test using 1
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 188 Calibration Menu Clotting

SAFETY IN OPERATION
1st conversion By pressing the Select Box arrow button you can select between 2 available
st
conversion modes to define the 1 conversion.
st
The following 1 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. Values are interpolated
from point to point.
Regression further entries are required to parameterize the
test and calibration curve. Regression is the best
fit over all measured calibration points.
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.
These conversion units will be used if QC Controls are set to result type
conversion, see chapter 5.4.4.5 Define QC-Control Parameter, Select
result type.
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 field, e.g. ON
=  (converted values rising).

SAFETY IN OPERATION
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.
The arrow marking in the Calib Value page indicate whether the
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
nd
nd

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.
nd
The ISI input field only appears if INR is selected in 2 conversion.

Quit

SAFETY IN 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
st
Figure 190 Calibration Values 1 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

reagent manufacturer.
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:

SAFETY IN OPERATION
 Raw values entered must be inside the defined Valid Clotting range,
see chapter 5.4.4.2 Evaluation.
 Converted values entered must be inside the defined conversion

range, see chapter 5.4.5.1 Edit Calibration for Clotting (manual
calibration), Convers. range
 Values entered must correspond to the rising/falling definition, see

chapter 5.4.5.1 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
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

5.4.5.1 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
5.4.5.1 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.

SAFETY IN 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 5.4.5.1 Edit Calibration for Clotting
(manual calibration), Display Calibration
Graph.
By pressing this button the calibration value
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 191 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.

SAFETY IN OPERATION
Figure 192 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.
ESC&Exit By pressing the ESC&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

SAFETY IN OPERATION
5.4.5.2 Edit Calibration for Kinetic / Diff. /

st
1 deri (manual calibration)

st
Select Kinetic/Diff./1 deri. by using the arrow keys to enter calibration
parameters for tests not using seconds as raw values or to define
nd
parameters for a test using 2 evaluation.
Basically this section is structured in the same way as already described in

chapter 5.4.5.1 Edit Calibration for Clotting (manual calibration). For
nd
further entry of calibration parameters based on the 2 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.
st
Figure 194 Calibration Menu Kin/Diff/1 deri

SAFETY IN OPERATION
st
st

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


=  (converted values rising).
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.

SAFETY IN OPERATION

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

SAFETY IN OPERATION
nd
Figure 196 Calibration Values 2 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

reagent manufacturer.
Option 2:
 Enter manually the evaluated results achieved by a normal

measurement with dilutions or if available with standard plasmas.

range, see chapter 5.4.5.2 Edit Calibration for Kinetic / Diff. / 1st deri
(manual calibration), Convers. range.

chapter 5.4.5.2 Edit Calibration for Kinetic / Diff. / 1st deri (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.

SAFETY IN OPERATION
Example: 1 + 9.0 = 1 part standard plasma will be diluted with 9 parts

invalid = The converted value entered deviates from the

following conditions:

5.4.5.2 Edit Calibration for Kinetic / Diff. / 1st deri,
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
5.4.5.2 Edit Calibration for Kinetic / Diff. / 1st deri, Convers. range.
Tools The Tools button in the Calibration Value Screen offers several options and
Figure 197 Tools in Calibration Value Screen

SAFETY IN OPERATION

Quit
By pressing this button the entered calibration curve

points will be displayed as graph, 5.4.5.1 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
analyzer.
OK Press the OK button to return back to the Calibration Menu Main Screen.

SAFETY IN OPERATION
5.4.5.3 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 199 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.

SAFETY IN 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 derivation defined unit/activity.
1st deri.: Converts raw value [mE/sec.] into a

Before selecting the calibration mode in this screen the

corresponding evaluation mode must be assigned to the test first,
see chapter 5.4.4.2 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.
Before starting an Auto Calibration make sure the following has been done:
 The reagent supposed to be calibrated must be set to calibrate, see

chapter 5.4.3.1 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.

SAFETY IN OPERATION
Calculation Press the Calculation button in Edit Calibration to access the Calibration
Figure 201 Calibration Menu Clotting
st
st

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


SAFETY IN OPERATION

=  dark blue (converted values rising).
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.
2nd conversion By pressing the Select Box arrow button you can select between 3 available
nd
nd

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).
nd
For Fibrinogen a 2 conversion is not required and should be set to none.

SAFETY IN OPERATION

Quit
Enter Calibration Values Press the Calib Values button in Edit Calibration to access the Calibration
Figure 203 Calibration Values (concentration)

SAFETY IN 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 5.4.5.1 Edit Calibration for Clotting (manual
calibration), Convers. range

chapter 5.4.5.1 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.
Example: 1 + 9.0 = 1 part standard plasma will be diluted with 9 parts

invalid = The converted value entered deviates from the following

conditions:

5.4.5.1 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 5.4.4.1
Liquids, Buffer/Diluent., please refer to explanation as provided below.

SAFETY IN OPERATION
The concentration value entered for automated calibration depends

on the entry of the dilution ratio as defined in the Test Setup for the
particular test, see chapter 5.4.4.1 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

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.

SAFETY IN 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 205 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

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: 1 - 20 (%).
Once the single values are outside of this range the single values will be
marked by the software.

SAFETY IN 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 206 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

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

joblist.
Figure 207 Reagent Status List Calibration

SAFETY IN 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 208 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.

SAFETY IN OPERATION
The analyzer 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 209 Running Measurement Calibration
Tools The Tools button in Running Measurement offers several options and
Figure 210 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

SAFETY IN OPERATION
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 211 Reaction Curves Calibration
 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 212 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:

SAFETY IN OPERATION
Figure 213 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 coloured 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.
OK Leave this screen by pressing the OK button to return back to the

Calibration Menu Main Screen.
Figure 214 Warning Message Calibration

SAFETY IN OPERATION
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 215 Warning Message Measuring Status
Confirm this message by pressing the OK button, the following display

appears:
Figure 216 Auto Calibration finished
The auto calibration run is finished now, all measured data have been
added to the calibration curve/data. Confirm this message by pressing the
OK button, the following display appears:

SAFETY IN OPERATION
Calib. Values To verify and view the calibration data and curve press the Calib Value
button. The following display appears:
Figure 218 Calibration data
In case no raw value [0.0 sec] could be measured for 0.60 g/l concentration as
an example 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 20.3 [sec] for this calibration step.

SAFETY IN OPERATION
Show calibration curve By pressing the Tools button followed by the Graph button the latest
calibration curve will be displayed.
Figure 219 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 220 Tools in Calibration Graph Screen

SAFETY IN 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.

SAFETY IN OPERATION
5.4.6 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
available results from the ring result memory of the analyser. There
will be no option to recover these results once deleted.
Figure 221 Delete Results
 Press the Delete Results button, the following message appears.
Figure 222 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.

SAFETY IN OPERATION
5.4.7 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 223 Setup Language
 Press the Language button, the following message appears.
Figure 224 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).

SAFETY IN OPERATION
5.4.8 Setup Date & Time

The button Date & Time in the Setup Menu allows you to set the actual date
& time information of the analyzer.
Figure 225 Setup Date & Time
 Press the Date & Time button, the following message appears.
Figure 226 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
ESC&Exit By pressing the ESC&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.

SAFETY IN OPERATION
5.4.9 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 227 Change Password
 Press the Passwords button, the following message appears.
Figure 228 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.

SAFETY IN OPERATION

Quit
ESC&Exit By pressing the ESC&Exit button you will leave the Password Menu without
Save&Exit Pressing the Save&Exit button in the Password Menu confirms changes
and modifications done in this menu.
5.4.10 Setup Beeper

The check box button Beeper in the Setup Menu allows you to activate
acoustical response performed by the analyzer software in case of warning
messages or problems occur.
Figure 229 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 field, e.g. ON =  (beeper active).

SAFETY IN OPERATION
5.4.11 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 230 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 field, e.g. e.g. ON = 
(STAT autoprint active).
5.4.12 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 analyzer. The headline may be
used to define the name of the analyzer or to identify the respective
department the analyzer is used.
Figure 231 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.

SAFETY IN OPERATION
5.4.13 Initiate Analyzer Selftest

The button Selftest in the Setup Menu allows you to check the general
analyzer 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 232 Selftest
 Press the Selftest button to start the self test sequence of the analyzer.
At first the photometer transmissions will be checked.
Figure 233 Selftest Transmission
 Confirm this message by pressing the Yes button. Now the analyzer
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:

SAFETY IN OPERATION
Figure 234 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.

SAFETY IN OPERATION
5.5 Switch off analyzer
To switch off the analyzer follow the next steps as described in below
section.
 From the Main Menu, press the button Shutdown.
Figure 236 Shutdown Analyzer
The following selection appears:
Figure 237 Shutdown Selection
The following Selection is available:

Quit window without any changes. An analyzer info
window will be displayed shortly.
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.
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 Analyzer 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
precautions listed in chapter 2 HAZARD AND PRECAUTIONS of this
manual.
Power down the analyzer and disconnect the power cord from the facility
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 (Intensive 1)
Clean waste water tubing using Cleaning
X X
Solution
Fill wash station with Cleaning Solution,
X X
wait 2 minutes & run flush cycle
Clean pipettor tip X X
Clean distilled Water Container and

2x X
sensor (70% alcohol solution)
Renew DI water in distilled water container X X
Clean Waste Water Container and

X X
sensor (70% alcohol solution)
Clean the housing (70% alcohol solution) X X
Replace distilled + waste water container X X
Replace fresh water filter at distilled water

X X
sensor (green)
Replace 250 µl syringe X X
Replace DI water tubing (Maintenance Kit) X X
Check/replace sample positions insert in

X X
working plate incl. single insert segments
Reverse flush of Pipettor with hot distilled
X X
water
Recalibration of photometer (automated by
X X
service software)
Check/Replace pipettor (recommended) X X
Check/Replace dilutor valve

X X
(recommended)
Optical inspection, cleaning & lubrication of
X X
X/Y/Z cogwheel and toothed rack
Check of Measuring rotor and Pipettor
X X
temperatures
Check motors and pumps for noise X X
Check of USB-port connectors for printer

X X
and USB-stick for wear out / function

SAFETY IN OPERATION
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.
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.
Avoid any direct skin contact with samples and/or test reagents as
well as those parts of the instrument which might be contaminated
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.
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 Connect 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 analyzer, see chapter 4.3.2
Connect 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.
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 238 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

analyzer 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 analyzer 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

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

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 239 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

analyzer 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 analyzer 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

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 Analyzer
The following must be considered when disposing of the Analyzer:
 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 Analyzer 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. 5.4.4.2, 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.
State: Q QC Error: Run QC measurements with test

A test under Quality Control must be using the assigned control
measured within the last 24 hours using the plasmas prior starting a routine
assigned control plasma before a routine run. Ensure test is verified and
measurement can be done. Additionally this not in violation to the Westgard
test may not be in violation to the Westgard- rules.
Rules. The Q Error will appear in case these
requirements are not fulfilled.
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.

SAFETY IN OPERATION
Error Cause Action

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.
Test has no valid calibration Test applied for a run has no valid Enter calibration data for this test
calibration. first, see chapter 5.4.5
Reagent has no valid The stability of a reagent has timed out. Renew reagent stability, see
stability chapter 5.2.2, 5.4.3.1
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.

SAFETY IN OPERATION
Error Cause Action

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
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.

SAFETY IN OPERATION
Error Cause Action

Invalid Cuvette ID Cuvette type on cuvette card does not Contact technical service
correspond to cuvette type on analyzer.
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
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 analyzer, 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. analyzer

SAFETY IN OPERATION
6.2.4 How to change fuses

The analyzer 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
analyzer 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.
Figure 240 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.
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 Coagulyzer 100 (405/570/740nm) CG0100
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 2 fuses (230V) --
1x CD-ROM with Operators Manuals --
1x Packing carton and foam inserts --
7.2 Disposables/Consumables
Material Order No.
Cuvette Rings Cuvette Rings, incl. Stir Bars CG0114

6x10 rings (1920 measurements)
Sample Cups Sample Cups 4ml CG0115

2x250 Cups
Washing Solution Washing Solution 15ml (thrombin inactivator) CG0117

5x15ml bottles
Cleaner Cleaner (pipettor/tubing) CG0116

6x12ml bottles
Teflon Stir bars Stir bars for reagent mixing CG0118

10x13mm
Reducer Rings Reducer rings for reagent vials 5ml 103-97-140-00

1x3 rings
Barcode Scanner 1 x external Barcode Scanner, incl. cable CG0113

APPENDIX
7.3 Maintenance Kit
Kit consists of Order No.
Maintenance Kit: 103-93-010-00
1x Liquid System Tubings --

1x Distilled Water Container, incl. screw lid --
1x Waste Water Container, incl. screw lid --
1x Distilled Water Sensor (green) --
1x Waste Water Sensor (red) --
1x 12 Filter for Distilled Water Sensor --

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 108/h, aPTT 60/h, +/- 20 tests/h
Cuvette volume min. 150 µl, max. 300 µl (test suspension)
Measuring channels Two measuring channels at

- three wavelengths 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
Dilutor 250µl syringe

APPENDIX
- 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 (WxDxH): 56.5 x 64.6 x 31.0 cm 22.2 x 25.4 x 12.2 in.
Shipping: 71.0 x 84.0 x 50.0 cm 28.0 x 33.1 x 19.7 in.
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,
which certifies conformity with the requirements of the following European
directives:
98/79/EC in-vitro Diagnostics directive
EN55011:2007 + A2:2007, EN61326-2-6:2006, EN61000-3-2:2006,

EN61000-3-3:1995 +A1:2001 +A2:2005, EN60601-1-2:2007, EN591:2001
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

User Manual Coagulyzer 100: For In-Vitro Diagnostic Use Only!

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

User Manual Coagulyzer 100: For In-Vitro Diagnostic Use Only!

Uploaded by

Copyright:

Available Formats

User Manual

For in-vitro diagnostic use only!

Analyticon Biotechnologies AG Coagulyzer 100 is registered trademark of Analyticon Biotechnologies AG.

1.0 03/23/11 V1.04 Initial version

Exclusions of manufacturer’s 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

Coagulyzer 100 – Operators Manual 1.0 Page 1

5.2.7 Results Memory -------------------------------------------------------------------------- 89

Coagulyzer 100 – Operators Manual 1.0 Page 2

6.1.8 How to dispose of used disposables ----------------------------------------------- 203

Coagulyzer 100 – Operators Manual 1.0 Page 3

Coagulyzer 100 – Operators Manual 1.0 Page 4

Figure 69 STAT Rack 1..3.......................................................................................................................... 71

Coagulyzer 100 – Operators Manual 1.0 Page 5

Figure 138 QC Main Page ......................................................................................................................... 117

Coagulyzer 100 – Operators Manual 1.0 Page 6

Figure 207 Place Calibrator Position 1 ....................................................................................................... 179

Coagulyzer 100 – Operators Manual 1.0 Page 7

Read this manual carefully before you attempt to operate the

1.1 Intended use

The Coagulyzer 100 named hereafter as analyzer, is a fully automated

For in-vitro diagnostic use only!

* Depending on the analyzer 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 analyzer.

Coagulyzer 100 – Operators Manual 1.0 Page 8

2 HAZARD AND PRECAUTIONS

This chapter contains important hazard and precaution information.

Read this chapter before you attempt to operate the analyzer.

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

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.

Coagulyzer 100 – Operators Manual 1.0 Page 9

Unauthorized work on the analyzer can lead to the guarantee obligation

This is to be assumed in the following cases:

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

Wear safety gloves! There is the risk of infection.

Coagulyzer 100 – Operators Manual 1.0 Page 10

The liquid waste of the analyzer is potentially infectious. To reduce the

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

6. Accuracy and precision

7. Cuvette Ring handling

8. Restrictions for samples

Coagulyzer 100 – Operators Manual 1.0 Page 11

10. Barcode Scanner

- Avoid direct eye contact with the laser beam.

2.2 Standard Symbols

A large number of symbols are used in this Operator‟s Manual, on the