Opm A6p 1.03.03 en Rev8

Coatron A6 Plus
Operator's Manual
Teco Medical Instruments, Production + Trading GmbH

Operation Manual, Revision 8
Issued: Apr 2017
Document No:23 440 01
TECO GmbH
Updates
Operator's Manual Software
Version Version
7 1.03.01
8 1.03.03
Copyright Copyright © 2017 by TECO GmbH. Neither the Operator's Manual

nor any part thereof may be copied, digitally processed or
otherwise transferred without written permission from TECO
GmbH. The software for TECO GmbH products is the intellectual
property of TECO GmbH, which company retains all rights to usage
of the software. The purchaser of a COATRON A6 PLUS acquires
rights of use for this software
Trademarks COATRON is a trademark of TECO GmbH. Other product names

used in this Operator's Manual are trademarks of the respective
companies.
Manufacturer Instrument is produced by

TECO GmbH
Dieselstrasse. 1
D-84088 Neufahrn
Germany
Phone: +49 (0)8773 70780-0

Fax: +49 (0)8773 70780-29
Internet: http://www.teco-gmbh.com
Warranty The Coatron A6 Plus is warranted for a period of one year after
delivery or first installation. It covers any defects in material,
functionality or workmanship (see also the “General terms and
conditions”).The first installation must be registered with the
“Installation Record”
The warranty expires in case of failures caused by

 Accidident, neglect maintenance & serivce, abuse or misuse.
 Using unauthorized reagents, consumables or spare parts
 Unauthorized service. Any repair or service must be performed
by authorized persons.
Operator's Manual COATRON A6 PLUS Revised Apr 2017 REV-8 Page 2

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1. Introduction......................................................................................................................................................... 8
1.1 Symbols .......................................................................................................................................................8
1.2 Safety information ..................................................................................................................................9
1.2.1 Intended use ........................................................................................................................................9
1.2.2 Safety information for operation ................................................................................................9
1.2.3 Safety information for MATERIALS ...........................................................................................9
1.2.4 Safety information regarding risk of health ........................................................................ 10
1.2.5 Safety information for cleaning, maintenance and servicing ....................................... 11
1.2.6 Electrical safety ............................................................................................................................... 12
1.2.7 Emc sTATEMENT ........................................................................................................................... 14
2. Installation of the COATRON A6 PLUS .................................................................................................. 15
2.1 Scope of delivery .................................................................................................................................. 15
2.2 Laboratory Requirement .................................................................................................................. 16
2.3 Unpacking the COATRON A6 PLUS............................................................................................... 16
2.4 Switching ON and off .......................................................................................................................... 17
2.5 Installation of Components.............................................................................................................. 19
2.6 Installation of TECAM software ..................................................................................................... 20
2.7 installation Record & Warranty ..................................................................................................... 21
3. Description of the COATRON A6 PLUS .................................................................................................. 22
3.1 Short introduction ............................................................................................................................... 22
3.2 Views of the device.............................................................................................................................. 23
3.2.1 Overview ............................................................................................................................................ 23
3.2.2 Rear view ........................................................................................................................................... 24
3.2.3 REAGENT Positions ....................................................................................................................... 24
3.2.4 Keypad ................................................................................................................................................ 27
3.2.5 Screen segments ............................................................................................................................. 28
3.3 Measurement principle ..................................................................................................................... 28
3.3.1 Mathematical principles .............................................................................................................. 28
3.3.2 Units ..................................................................................................................................................... 29

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3.3.3 Clotting method............................................................................................................................... 30
3.3.4 Derived fibrinogen ......................................................................................................................... 30
3.3.5 Chromogenic, endpoint and immunoturbidimetric method ........................................ 31
3.4 Test overview ........................................................................................................................................ 32
4. Operation of the COATRON A6 PLUS ..................................................................................................... 33
4.1 Routine measurement with TECAM............................................................................................. 34
4.2 Routine measurement without TECAM ...................................................................................... 37
4.3 Interrupt or exit measurement ...................................................................................................... 39
4.4 Out of liquid or cuvette during measurement ......................................................................... 39
4.5 Continous loading of samples ......................................................................................................... 40
4.6 Measuring the emergency samples .............................................................................................. 41
4.7 Measuring the samples in micro tubes ....................................................................................... 42
4.8 Quality control measurement ......................................................................................................... 43
4.9 Reflex testing ......................................................................................................................................... 44
4.10 Display during measurement ......................................................................................................... 44
4.11 Result warning messages ................................................................................................................. 45
5. Menu Analysis.................................................................................................................................................. 46
5.1 Submenu New List............................................................................................................................... 46
5.2 Submenu Continue .............................................................................................................................. 51
5.3 Submenu Repeat .................................................................................................................................. 51
5.4 Submenu Stat......................................................................................................................................... 52
5.5 Submenu Overview ............................................................................................................................. 53
5.6 Submenu Print Option ....................................................................................................................... 54
5.7 Submenu Cuvette Activation ........................................................................................................... 55
5.8 Submenu System Activation............................................................................................................ 55
5.9 Submenu Reagent Activation .......................................................................................................... 56
6. Menu Setup Test ............................................................................................................................................. 57
6.1 Calibration Curve ................................................................................................................................. 58
6.2 Reagent barcode ENTRY ................................................................................................................... 61

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6.3 Storing of test data .............................................................................................................................. 61
6.4 Submenu Test Printout ..................................................................................................................... 62
7. Menu System Setup ....................................................................................................................................... 63
7.1 Language ................................................................................................................................................. 63
7.2 Date............................................................................................................................................................ 63
7.3 Time........................................................................................................................................................... 63
7.4 Signal......................................................................................................................................................... 63
7.5 Contrast.................................................................................................................................................... 64
7.6 Mixer ......................................................................................................................................................... 64
7.7 Simulator ................................................................................................................................................. 64
7.8 SHIELD ..................................................................................................................................................... 64
7.9 COOLING .................................................................................................................................................. 64
8. Menu SERVICE ................................................................................................................................................. 65
8.1 Refill Cuvettes ....................................................................................................................................... 66
8.2 Insert printer paper ............................................................................................................................ 66
8.3 System report ........................................................................................................................................ 67
8.4 Adjust XYZ............................................................................................................................................... 68
8.5 Check Temperature ............................................................................................................................ 70
8.6 Check Optics ........................................................................................................................................... 71
8.7 Check Robot ........................................................................................................................................... 71
8.8 Move Cuvettes ....................................................................................................................................... 71
8.9 Clean Needle .......................................................................................................................................... 71
8.10 Replace Rinse tank .............................................................................................................................. 71
8.11 Adjust Motor .......................................................................................................................................... 73
8.12 Microtube ................................................................................................................................................ 73
8.13 INIT SYSTEM .......................................................................................................................................... 74
8.14 Reset service Interval......................................................................................................................... 74
9. Menu PIPET STATION .................................................................................................................................. 75
10. Cleaning and maintenance ......................................................................................................................... 76

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10.1 General cleaning information ......................................................................................................... 76
10.1 Cleaning ................................................................................................................................................... 76
10.2 Decontamination.................................................................................................................................. 76
10.3 Daily activities ....................................................................................................................................... 77
10.4 Weekly activities .................................................................................................................................. 77
10.5 Yearly activities .................................................................................................................................... 77
10.6 Regular Replacements ....................................................................................................................... 77
11. Elimination of malfunctions....................................................................................................................... 78
11.1 Error messages ..................................................................................................................................... 78
11.2 Device malfunctions ........................................................................................................................... 79
11.3 Measurement malfunctions ............................................................................................................. 80
12. Appendix ............................................................................................................................................................ 81
12.1 Technical data ....................................................................................................................................... 81
12.2 Transport and Storage ....................................................................................................................... 84
12.3 Disposal and recycling ....................................................................................................................... 84
12.4 Barcode Guideline ............................................................................................................................... 85
13. Index .................................................................................................................................................................... 86

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List of figures
Figure 1: COATRON A6 PLUS, Overview ....................................................................................... 23

Figure 2: COATRON A6 PLUS, Rear view ...................................................................................... 24
Figure 3: Working Positions ............................................................................................................. 26
Figure 4: Keypad .............................................................................................................................. 27
Figure 5: Screen segments .............................................................................................................. 28
Figure 6: Determination of turning point in clotting method ............................................................. 30
Figure 7: Determination of rise in the kinetic test method ................................................................ 31
Figure 8: Worklist Screen of Tecam ................................................................................................. 34
Figure 9: Test Order Screen of Tecam ............................................................................................ 34
Figure 10: RUN WORKLIST Screen of Tecam ................................................................................ 35
Figure 11: Receive Result Screen of Tecam ................................................................................... 36
Figure 12: Emergency Samples ....................................................................................................... 41
Figure 12: Emergency Samples ....................................................................................................... 42
Figure 14: QC sample ...................................................................................................................... 43
Figure 15: QC sample ...................................................................................................................... 43
Figure 14: Installation of cuvettes..................................................................................................... 66
Figure 15: Installation of printer paper ............................................................................................. 66

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1. INTRODUCTION
This device left the factory in fault-free condition regarding its safety and
engineering functionality. To maintain this condition and ensure risk-free operation,
the operator must comply with the safety warnings and information in this
Operator's Manual.
Use the COATRON A6 PLUS only in compliance with the instructions in this
 Operator's Manual. Otherwise the manufacture shall exclude the liability
for any damages to the COATRON A6 PLUS, patients or operators.
1.1 SYMBOLS
The following standard symbols are used in this manual:
Symbol Meaning Explanation
Courier Info Key on keypad.
CAPS Info Screen message.
 Read Indicates important information and tips.
Describes reaction of COATRON A6 PLUS

 Info
to operator input.
Risk of possible health damage or
Warning considerable damage to equipment if
warning is not heeded.
Potential risk to operating personnel or
Danger
equipment due to electric shock.
Equipment can be potentially infectious

Biohazard
due to the samples and reagents used .
Laser Radiation Avoid direct eye exposure

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1.2 SAFETY INFORMATION
1.2.1 INTENDED USE

The COATRON A6 PLUS is designed to carry out coagulometric tests such as PT,
PTT, TT, fibrinogen, single factor tests, chromogenic and immunoturbidimetric
tests (for instance Antithrombin, D-dimer etc.).The instrument has to be used
for the expected purposes and in perfect technical conditions, by qualified
personnel, in working conditions and maintenance operations as described in
this manual, according to the SAFETY WARNINGS. This manual contains
instructions for professional qualified operators.
Do not use plasma with more than 50mg/dL Bilirubin (856µmol/l)

Do not use plasma with more than 2000mg/L Hemoglobin
Do not use plasma with more than 50 g/l Triglceride (57 mmol/l)
Use only citrated plasma for sample analysis. Mix 9 parts of venous blood
with 1 part 3.2% (0.105M) sodium citrate and centrifuge the mixture at
1500g x 15min. Use plasma within 4 hours.
1.2.2 SAFETY INFORMATION FOR OPERATION

Use only the cleaning and rinsing liquids approved by the manufacturer.
Failure to do so could result in faulty measurements or malfunctions of the
COATRON A6 PLUS.Prevent reagents from leaking into the Analyzer. Failure to
do so may make expensive maintenance work necessary!
Never touch moving parts such as the measurement rotor or pipetting arm
during device operation.Never try to pull a cuvette block out of the
measurement rotor during test processing operation.Carry out control
measurement runs at regular intervals to ensure that the Analyzer continues
to function faultlessly.
If instrument is used in a manner not specified by the manufacturer, the

protection impairment could be affected!
1.2.3 SAFETY INFORMATION FOR MATERIALS
Important!
Use only organic solvents where specified.The cuvettes are intended as
single-use items only. Repeated use may result in false results due to
contamination.Follow the instructions in the reagent package circulars.
Incorrect handling may result in falsified results.

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1.2.4 SAFETY INFORMATION REGARDING RISK OF HEALTH
Infectious Material
Avoid direct contact with samples and sample residues in the used cuvettes.
Infectious material such as cuvette waste and liquid waste must be disposed
in compliance with local regulations governing for infectious materials.
Wear medical infection grade protective gloves for all cleaning and
maintenance works involving potential contact with infectious liquids and
use each pair of gloves once only. Use a hand disinfectant product, e.g.
Sterilium®, to disinfect your hands after completion of the work.
NOTICE
Analytical instruments for in vitro diagnostic application involve the handling
of human samples and controls which should be considered at least
potentially infectious. Therefore every part and accessory of the respective
instrument which may have come into contact with such samples must
equally be considered as potentiallyinfectious. The „BIOHAZARD“ warning
label must be affixed to instrument prior to first use with biological material!
Laser Radiation
The internal barcode scanner is assigned to
laserclass 2 – EN60825-1:2007.
Avoid direct eye exposure
max. power = 1.7 mW pulse period = 420 µs wavelength = 655 nm

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1.2.5 SAFETY INFORMATION FOR CLEANING, MAINTENANCE AND

SERVICING
About authorized service !

Carry out only the maintenance, repair and replacement measures listed in
this Operator's Manual. Improper manipulation of the device will void the
manufacturer's liability obligations and may make service calls necessary,
payment of which is not covered by warranty.Only the authorized Customer
Service may carry out servicing. Only original replacement parts may be
used. Before doing any servicing on the instrument it is very important to
thoroughly disinfect all possibly contaminated parts
Abount cleaning and decontamination !

Before the instrument is removed from the laboratory for disposal or
servicing, it must be decontaminated. The procedure is described in chapter
“10 Cleaning and maintenance” and should be performed by authorised
well-trained personnel only, observing all necessary safety precautions
Cleaning certificate required !

Instruments to be returned have to be accompanied by a decontamination
certificate completed by the responsible laboratory manager. If a
decontamination certificate is not supplied, the returning laboratory will be
responsible for charges resulting from non-acceptance of the instrument by
the servicing centre, or from authority’s interventions.
Regard all surfaces and materials which might be in contact with plasma
or other biological liquid as potentially contaminated with infectious
material.
Avoid any direct contact with decontaminants or disinfections.

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1.2.6 ELECTRICAL SAFETY
Precautions:
 Avoid spilled iquids into system. But in case disconnect system from
power and clean and dry all contaminated parts.
 Remove power cord before open the instrument
 Do not touch any electronic parts during operation.
 Do not operate system without proper connection to grounding
 Never intentionally interrupt protective ground contacts.
 Never remove housing elements, protective covers or secured structural
elements, since so doing could expose parts carrying electric current.
 Make sure surfaces such as the floor and workbench are not moist while
work is being done on the device.
 Check electrical equipement regulary. Defective leads or socket must be
replaced without delay.
Connect to power:
Instrument is classified to Class-1 ( IEC) and must therefore be reliably
earthed and professionally installed in accordance with the prevailing
electrical wiring regulations and the safety standards covered herein.
 Use only three wire power cord.
 Make sure the operating voltage setting is correct before connecting the
device to the power mains.
 Ensure at least 20cm space to power socket and instrument power
ON/OFF switch for easy and quick access to power cord during
operation.
Disconnect from power:

 Unplug power cord from wall socket/UPS or from instrument power–in

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Fuse replacement:
Unplug power cord and remove back casing. All fuses are located on the
power board and identified as FH1 – FH7. Use only following fuses:
Glas micro fuse 5x20mm

Time Delay = T (100-300ms)
Nominal Voltage 250V
Nominal Current:
FH1=3.15A FH2=3.15A FH3=0.50A FH4=3.15A

FH5=1.60A FH6=1.60A FH7=1.60A
Further fuses are located inside of power supply and inside of robotics.
Power supply internal fuse (FS1): 6.3AH, 250V, 5x20mm
Robotic internal fuse (FS1): 4.0AH, 250V, 5x20mm

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1.2.7 EMC STATEMENT
Coatron A6 Plus complies with the requirements of emission and immunity,

pursuant to GB/T 18268.1 (IEC 61326-1) and GB/T 18268.26 (IEC61326-2-6).
Coatron A6 Plus has been designed, tested and found to comply with Class A
device, pursuant to GB 4824 (IEC 61000-4). In domestic environment, this
device may cause radio interference, in which case the user is required to take
adequate measures.
Detecting electromagnetic environment is recommended before using this

device.
To avoid operating this device nearby strong radiation source (for example,
non-shielded RF source), which may interfere with the device working
correctly.

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2. INSTALLATION OF THE COATRON A6 PLUS
Initial startup of the COATRON A6 PLUS should be carried out by the authorized
 Customer Service. After first installation print out a system report (see chapter 8.3 )
and sent to the manufacturer as a basis for processing guarantee claims.
Procedures of first installation:
1. Unpack and place instrument in conformity with the laboratory requirements

2. Connect Power
3. Connec TECAM interface to PC
4. Install consumables ( Rinse tank, waste tank, paper, cuvettes)
Connect power
Connect TECAM
5. Switch on
6. Goto menu service and perform “Replace Rinse Tank”
7. Goto menu service and print system report and sent to manufacturer to enable
warranty period.
8. Install TECAM software
2.1 SCOPE OF DELIVERY

The scope of delivery can be different from customer to customer and must be read in
the document “List of accessories”, which is separately included to the operation
manual on the first page.

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2.2 LABORATORY REQUIREMENT

1. Power Input: 100 – 240VAC; 45-63Hz ; Class-1 socket ( connected to earth)
2. Ambient temperature must be 15-30°C
3. Rel. humidity < 70%
4. Altitude 0 - 3000m
5. A stable, flat surface free of vibrations. Recommended workspace 80x150cm. On
rearside a minimum space of 20cm is required.
6. No direct sunlight
7. Avoid ionizing air conditioner or circulating air
8. Surroundings free of moisture and dust
2.3 UNPACKING THE COATRON A6 PLUS

Inspect the packaging of the COATRON A6 PLUS for any visible external damage. If the
packaging is damaged, contact the transport company so that any damage to the device
or accessories can be assessed.
Inspect the COATRON A6 PLUS and accessories for any damage. Report any damage
found to the dealer without delay.
Even if the packaging appears undamaged, check the analyzer and accessories for any
transport damage, caused for example by impact, dropping, etc. during transport.
1. Lift instrument on the 4 notches on the side out of packaging. Two persons are
required and placed it on a stable table.
2. Remove the cable binders on the pipetting arm.
3. Remove the foam element between the pipetting arm and protective bar
 Keep the original packaging material for purposes of later transport

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2.4 SWITCHING ON AND OFF

Switching on
1. Make sure the instrument is connected to the power mains.
2. Check for sufficient rinsing and cleaning fluid levels.
3. Set power switch to on. See right side of instrument
The following screen appear after switch on.
Coatron A6 Pluss Name of instrument

V6.03.02 Version of firmware
SN-12345 Serialnumber
Service: 100000 Tests until next service
CUVETTES:1 Activated cuvettes
RINSE: 0 Activated Rinse tank
REAGENT: CLOSE Reagent system is closed
There is no information about cuvette or Rinse or reagent , if system is

 configurated as “OPEN DEVICE”. Please contact local distributor for more
information about open or closed system.

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At the end of the initialization phase, the main screen appears:
1 ANALYSIS
2 SETUP TEST
3 SETUP SYSTEM
4 SERVICE
5 PIPET STATION
12:00 1055mL LIS 37.0°C
MAIN SCREEN:
Time= 12:00
Rinse installed = 1055mL
LIS = online
Temperature at cuvette= 37°C
After about 15 min. of warm-up time (depending on the ambient temperature), the
lighting up of the LED (Temp.) on the keypad indicates the system is ready to make
measurements.
Switching off:
For normal shutdown at the end of the day and for changing the pipetting needle,
rinsing solution tank and syringe, switch off the instrument with the standby switch on
the right side of the housing. This will shut off all power-consuming components except
of the ventilator. For longer interruptions in operation such as weekends, holiday
periods and service activities such as cleaning and maintenance, switch off the mains
power switch as well.
Switching off the device deletes all measurement data. Backup the
data as required by means of manual printout or manual
 transmission to the host
Never switch off the system while processing a worklist to avoid

clogging the needle tip with coagulation residues.

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2.5 INSTALLATION OF COMPONENTS
 Plug in power cord

 Plug download cable into left port and connect
with PC
 Remove a strip of cuvettes from the package.

 Shift the cuvettes as shown from above in the
guide groove back into the cuvette tower.
 Remove the tape off the cuvettes.
 Activate cuvettes by barcode if required
 Place a new Rinse tank as shown
 Load thermo paper as shown

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2.6 INSTALLATION OF TECAM SOFTWARE
TECAM software is a powerful enhancement of the Coatron A6 Plus and allows very easy
and flexible to generate orders (including sample continous loading). Results can be
reported including the reaction curve and administrate in a database. For further
information read the online manual of TECAM software
System requirement
 Operating system: Microsoft Windows XP or 7
 100 MB free hard-disk space
 Grafik: 1280x1024 Pixel
 Interface: RS232 Sub-D9 (if not supported , use USB convertor, commport
must be set between com1 - com15)
 Cable: 2x Female Sub D9, crosslink. Pin 2 to 3; Pin 3 to 2 and Pin 5 to 5. All other
wires should be disconnected.
Install:
Figure 2: COATRON A6 PLUS, Rear view
1. Link instrument left RS232 port (location #19) to PC

2. Check PC comport number ( it must be between 1 to 15)
3. Start "SETUP.EXE" from the CD. The Setup will install Smart ,PRO or PROLIS
and all required driver for database access.
4. Enter fingerprint and activation code
 The Each instrument TECAM license can be installed on any PC, but is locked to the
serial number of instrument

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Run TECAM:
1. Switch on and bootup instrument

2. Start TECAM and enter administrator password ( default = blank) or enter
“Blank” to login as a restricted user
3. Tecam search automatically for any available system and connects.
TECAM is linked to system “15000” over com port 1. No ASTM is active
4. Enter administrator password ( default = blank) or enter “Blank” to login as a

restricted user
 TECAM license can be installed on any PC, but is locked to the serial number of
instrument
2.7 INSTALLATION RECORD & WARRANTY
The manufacturer must be informed about date and correct procedure of installation. For
this the “Installation Record” is attached to the delivery.
Fill out the record completely and send it to manufacturer by email or telefax.
 The term of warranty will begin with the date of delivery or first installation

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3. DESCRIPTION OF THE COATRON A6 PLUS
3.1 SHORT INTRODUCTION

The COATRON A6 PLUS is a fully automated laboratory analyzer for the fast and flexible
coagulation diagnostic. It is equipped with six optical channels and offers clotting,
chromogenic and immunological testing in random acces mode as well as fast processing
of STAT samples. All sample dilutions and assay calibration are performed automatically.
ID-barcode scanner is on board. CAP Piercing is supported for any primary tube system.
The analyzer is also focused on a minimum consumption of consumables and reagents,
which makes the analyzer very cost effective. The nearly zero service requirements will
ensure a long living device by a minimum of service costs. The analyser can be linked to
powerful LIMS software to give exceptional features like unlimited result traceability by
an one click report engine or a unique quality control system with Levey Jennings chart
and Westgard rules
Based on the optical measurement principle used by this device (transmitted light
turbidimetry) with ultraviolet light, a number of coagulation and fibrinolysis parameters
can be determined, for example
 Prothrombin time (Quick or Owrens)

 Activated partial thromboplastin time ( APTT)
 Fibrinogen (FIB) (Clauss) & derived PT (DFIB)
 Thrombin time (TT)
 Single factor measurements
 Protein C (PC)
 Protein S (PS) + free Proteion S ( PSF)
 Lupus Anticoagulant (LA)
 Activated protein C resistance (APCR)
 Heparin (chromogenic)
 ATIII (chromogenic)
 D-dimers (immunoturbidimetric)
 Further tests on demand

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3.2 VIEWS OF THE DEVICE
3.2.1 OVERVIEW
FIGURE 1: COATRON A6 PLUS, OVERVIEW
1 Keyboard
2 Cuvette waste drawer
3 LCD Screen
4 Cuvette rotor
5 System block
6 Rinse solution waste drawer
7 Shield handle. Move to right to open.
8 Reagent and sample positions
9 Power switch ON/OFF
10 Barcode ID Scanner
11 Pump unit. Left=reagent, Up=Rinse, Right=sample probe,
12 Rinse solution tank 1.25mL (RINSE)
13 Sample probe tubing
14 Reagent probe tubingt
15 Integrated thermo printer
16 Cuvette tower
17 Shield, removeable

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3.2.2 REAR VIEW
FIGURE 2: COATRON A6 PLUS, REAR VIEW
Power Cord Power Input 85 – 264 VAC @ 45 – 60 Hz.

TECAM Interface to TECAM software,(115200 baud, 8,1,N
Free RS2322 Reserved for debugging
3.2.3 REAGENT POSITIONS
Pos. 1 - 45 Sample positions Room temperature
Reagent block: ~37°C ~15°C prewarm

51
48
70
73
54
55
63
66
58
67
62
59
LA-C LA-S PS-3, PSF2 PCA, PLG2 F2, PSF1 F5, HEP1 F7, F10 F8, PS-1 F9, PS-2 F11, F12 HEP2
46
74
5690
68
64
52
49
56
71
PT
FIB DD-1 PC-2 AT-1 PC-1
47
APTT
50
61
57
69
53
65
75
72
CaCl TT DD-2 AT-2 CP-1 CP-2 CP-3
Pos. 46 PT Position for PT, magnetic stirring function 36.5 - 37.5 °C

Pos. 47 CaCl Position for CaCl2 (Calcium Chloride) 36.5 - 37.5 °C
Pos. 48 LA-C Position for LA-C (Lupus Anticoagulant - Confirmation) 36.5 - 37.5 °C
Pos. 49 FIB Position for FIB (Fibrinogen) 36.5 - 37.5 °C
Pos. 50 TT Position for TT (Thrombin Time) 36.5 - 37.5 °C
Pos. 51 LA-S Position for LA-S (Lupus Anticoagulant – Screen) 36.5 - 37.5 °C
Pos. 52 DD-1 Position for DD-1 (D-Dimer Reaction buffer) 36.5 - 37.5 °C
Pos. 53 DD-2 Position for DD-2 (D-Dimer Latex) 36.5 - 37.5 °C
Pos. 54 PS-3, PSF2 Position forPS-3 (Protein-S) 36.5 - 37.5 °C
Pos. 55 PCA, PLG2 Position for PCA (Protein C activated) and Plasminogen 36.5 - 37.5 °C
Pos. 56 PC-2 Position for PC-2 (Protein C) 36.5 - 37.5 °C
Pos. 57 AT-2 Position for AT (Antithrombin) 36.5 - 37.5 °C
Pos. 58 F2, PSF1 Position for Deficient Plasma II, <15 °C

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Pos. 59 F5, HEP1 Position for Deficient Plasma V and Heparin <15 °C
Pos. 60 APTT Position for APTT <15 °C
Pos. 61 CP-1 Position for Control plasma 1 <15 °C
Pos. 62 F7, F10 Position for Deficient Plasma VII and X <15 °C
Pos. 63 F8, PS-1 Position for Deficient Plasma VIII and Protein-S <15 °C
Pos. 64 AT-1 Position for AT (Antithrombin) <15 °C
Pos. 66 F9, PS-2 Position for Deficient Plasma IX and Protein-S <15 °C
Pos. 67 F11, F12 Position for Deficient Plasma XI and XII <15 °C
Pos. 68 PC-1 Position for PC-1 (Protein C) <15 °C
Pos. 70 HEP2 Position for HEP-2 (Heparin) 33 - 39 °C
Pos.71 - 75 Prewarm 5 x Position to prewarm reagents 33 - 39 °C

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System block:
76
BUF-1
77
BUF-2
78
BUF-3
79
80
IBS
CLEAN
STAT
WASH
FIGURE 3: WORKING POSITIONS

Pos. 76 BUF-1 Position for Buffer 36.5 - 37.5 °C
Pos. 79 IBS Position for Imidazole Buffered Saline 36.5 - 37.5 °C
Pos. 80 CLEAN Position for Clean A Solution 36.5 - 37.5 °C
WASH WASH Position for liquid waste and cleaning of the needle (probe)
STAT STAT Not used
Reagent adapters are found in the right-hand device drawer for various reagent
container or vials.
 The above test reagent allocations are only valid for the factory default
protocols.

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3.2.4 KEYPAD
FIGURE 4: KEYPAD
0-9 Numeric value input ARROW  Navigation key
Esc Leave screen ARROW  Navigation key
LF Line up, printer paper ARROW  Navigation key
Temp Display of standby to measure ARROW  Navigation key
status
Enter Input / selection confirmation
Use the arrow keys to change to the screens up, down, right or left. See chap. 5 for an
accurate description of software operations.

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3.2.5 SCREEN SEGMENTS
Title There are 3 screen segments:

 The current menu item appears in
the title line.
Menu  The main segment displays the
Info selection lists, information and
Message system messages.
 The bottom line contains the
current time, volume of Rinse
solution, status of host connection
12:00 1055mL H0 37.0°C
and the temperature in the Optic
Figure 5: Screen segments
block.
3.3 MEASUREMENT PRINCIPLE

Blood plasma is filled into a cuvette. Special reagents are added, which initiate the blood
coagulation. The cuvette is transmitted by ultra violet light during the coagulation
process. When the sample starts to clot a change of light absorance is measured. The
time from measurement start to change of light (turning point) is called clotting time
and expressed in seconds [s].
3.3.1 MATHEMATICAL PRINCIPLES

The conversion of coagulation time into a specific test unit is one using a linear,
hyperbolic, semi-logarithmic or double-logarithmic interpolation of the stored
calibration points. The current mathematical model is printed out in "TEST SETUP."
Values outside the calibration range are calculated by extrapolation and flagged as " * ".

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3.3.2 UNITS
Unit Info Decimal Maximum Unit

places value Reflex
s seconds 1 - -
% activity 1 180.0 <10%
U units 0 999 >600
INR int. ratio 2 30.00 -
R ratio 2 30.00 -
PR polish ratio 0 180 -
INR+ int. ratio 2 30.00 -
mg/dl 0 999 >600
g/l 2 9.00 >6
IE/ml Int. Einheit 2 9.00 -
mg/l 2 9.00 -
µg/ml 1 999.9 -
ng/ml 0 9000 >5000
µg/l 0 9000 >5

-
IU/mL Int. Units 3 9.000
R = clotting time / normal time

PR = 100 *(normal time/clotting time)
INR = Ratio ISI (International Normal Ratio)
INR+ = Like INR, except the ISI value is determined for a specific device.
This is done using a calibration curve with INR standards.
IU/mL = IE/mL = International Units (1.00 IU/mL = 100 % activity)
Unit Reflex= System repeat testing if

Result < Unit Reflex : Repeat with half sample dilution
Result > Unit Reflex : Repeat with double sample dilution

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3.3.3 CLOTTING METHOD
FIGURE 6: DETERMINATION OF TURNING POINT IN CLOTTING METHOD

The final reaction in the coagulation cascade is the transformation of
fibrinogen into fibrin catalyzed by thrombin. Fibrin formation results in
clouding (higher turbidimetric level) in the sample, which is measured by
the photometer and stored as the extinction. The result in seconds is the
time from the start of the reaction to the time of maximum rate of
change (reaction turning point). The instrument can be switched also to
define the clotting at the halfpoint of reaction .
3.3.4 DERIVED FIBRINOGEN

The photometric measurement method facilitates measurement of the
prothrombin time (PT) as well as, at the same time, derivation of the
relevant fibrinogen concentration.
The optical reaction rise (see figure above) between the start and end of
the fibrinogen transformation reaction is linearly proportional to the
fibrinogen concentration.
The DFIB results can give significant higher concentrations than compared to clauss
 method – especially for very high concentrations. Therefore method should only be used
to screen for abnormal levels and confirm these samples with FIB Clauss method.

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3.3.5 CHROMOGENIC, ENDPOINT AND IMMUNOTURBIDIMETRIC

METHOD
Extinction
Time (s)
End of test
FIGURE 7: DETERMINATION OF RISE IN THE KINETIC TEST METHOD
t1 = deadtime in s
t2 = endtime in s
Delta signal dE =E2 – E1

Delta time dT =t2 – t1
Result of method „CHROM“= 60 * ( dE/dT) [ dE/min]
Result of method „IMMUN = dE/dT
Result of method „POINT “= dE

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3.4 TEST OVERVIEW
test ID name of test displayed as Method

0 Prothrombin time PT clotting
1 Derived fibrinogen DFIB clotting
2 Activated partial prothrombin time PTT clotting
3 Fibrinogen FIB clotting
4 Antithrombin liquid (anti Xa) AT chrom
5 Thrombin Clotting Time TT clotting
6 D-dimers DD immun
7 Heparin HEP chrom
8 Protein-C PC chrom
9 Protein-S PS clotting
10 Factor II F2 clotting
11 Factor V F5 clotting
12 Factor VII F7 clotting
13 Factor VIII F8 clotting
14 Factor IX F9 clotting
15 Factor X F10 clotting
16 Factor XI F11 clotting
17 Factor XII F12 clotting
18 Plasminogen PLG chrom
19 APC clotting
Activated Protein-C resistance
20 APC clotting
21 LA confirm clotting
Lupus anticoagulant
22 LA screen clotting
23 free Protein-S PSF immun
24 Fibrin Degradiation Product FDP immun

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4. OPERATION OF THE COATRON A6 PLUS
Select menu item with cursors keys + ENTER or direct code (1, 2.,,)
1 ANALYSIS Statusbar Information:

2 SETUP TEST Time = 12:00
3 SETUP SYSTEM Rinse = 1150mL installed
LIS = online
4 SERVICE
Temp = 37°C
5 PIPET STATION
12:00 1055mL LIS 37.0°C
(main menu)
Short descriptions of main menu

1. ANALYSIS: Define and run worklist
2. Setup Test Calibrate methods
3. Setup System Change system parameter like time, date
4. Service Run service like replenish Rinse, needle
5. Pipet Station Menu to reconstitute reagent and controls

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4.1 ROUTINE MEASUREMENT WITH TECAM
 This chapter is just a very quick overview of TECAM. Please read TECAM online manual
for further informations
1. Switch on instrument
2. Run TECAM.
3. The worklist screen is automatically displayed
FIGURE 8: WORKLIST SCREEN OF TECAM
4. Import PID from analyser, if you work with patient barcode information.
 Click on command “LOAD”
 Goto analyser and scan the patient racks and press “ENTER”
5. Select position with cursor keys and click on command “EDIT” or press ENTER.
FIGURE 9: TEST ORDER SCREEN OF TECAM

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 Enter patient ID number ( external barcode sanner can be used)

 Enter patient’s information + required tests
 Press “OK” to continue with the next sample
 Press “Exit” to return to worklist menu
 QC: Sample is a quality control
 MICRO: Sample is filled into micro tube
 STAT: Sample is urgent
 AUTO: Use Auto-ID number instead of patient-ID
6. Select menu Worklist\Send worklist
FIGURE 10: RUN WORKLIST SCREEN OF TECAM
 Mode CUV, BAT, SEL

Run worklist cuvette or test or patient wise
 Run double determination
If yes, then all orders are run in duplicate
 Autoskip
If yes, then worklist is continued even some reagents are missing
otherwise system stops worklist.
 Reflex
If yes, then reflex testing is enabled
 Start Now
Send worklist and start it immediately
 Only Send
Send worklist. Goto analyser and press key “ENTER” to start the
worklist.

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7. Receiving results
FIGURE 11: RECEIVE RESULT SCREEN OF TECAM

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4.2 ROUTINE MEASUREMENT WITHOUT TECAM
 This chapter however describes how to work without TECAM in very short words. For
detailed information read chapter
Goto menu ANALYSIS and select NEW LIST and follow dialogue from screen1 to
screen4.
Select CONTINUE=YES to confirm and show the next screen
CONTINUE: YES
-A profile specification was defined.

TEST: PRFL
-The samples identifications are input manually.
BARCODE: NO
-Reflex testing is disabled
RELFEX: NO
-Double testing of control samples is disabled
DOUBLE: NO
-Autoskipping is disabled
AUTOSKIP: NO
-No sample to sample wash
CLEAN: MIN
-Shield detection is enabled
SHIELD: YES
MODE: CUV
-The worklist is processed in batch mode (first all PT, then
P
T
"New List" Screen 1
T
,
.
Select CONTINUE=YES to confirm and show the next screen .
CONTINUE: YES .
 6 samples were entered )
 The sample ID begins at 1000, 1001,..
SAMPLES: 6
 No QC number was entered
1.PID: 1000
 The profile PT+APTT+FIB was selected
CP-1: -
CP-2: - Select CONTINUE=YES to come to the next screen
TEST1: PT TEST5: -
TEST2: APTT TEST6: -
TEST3: FIB TEST7: -
TEST4: - TEST8: -
New List" Screen 2

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Press ENTER to confirm and show the next screen

P OS P ID 1 2 3 4 5 6 7 8
 Select the order record with cursor keys UP/DOWN.

P 01 1000 x x x
 Select the order items PID or TESTS with cursor keys RIGHT.
P 02 1001 x x x
P 03 1002 x x x
 If a PID is highlighted, use numeric keys to change the
P 04 1003 x x x
number and confirm with Enter.
P 05 1004 x x x
 If a TEST is highlighted, use Enter to (de)activate. Use dot
P 06 1005 x x x
key “.” to (de)activate the tests in all orders.
 To come to the next screen, use key RIGHT until the current
order is completely highlighted and press Enter.
1=P T 2=A P TT 3=FIB 4= -
5= - 6= - 7= - 8= -
"New List" Screen 3
Press ENTER to confirm and show the next screen
PREPARE SYSTEM
The COATRON A6 PLUS requires the following to process
the active worklist:
P46 800uL  800µl reagent in position 46=PT
P47 500uL  500µl reagent in position 47=CACL
P49 500uL
 500µl reagent in position 49=Fibrinogen
P60 500uL
P79 740uL
 500µl reagent in position 60=PTT
 740µL reagent in position 79=FIB buffer
CUVETTES 3  3 cuvettes
CONTINUE >> KEY ENTER
"New List" Screen 4
Check once again to make sure all reagents and cuvettes on the device are filled.
The worklist is started with Enter.

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4.3 INTERRUPT OR EXIT MEASUREMENT
Automatic interrupt of worklist:
Instrument will interrupt worklist automatically, if it runs out of reagent or cuvette

during measurement.
Manual interrupt worklist: Press key ESC:
Robotic will finish current command and moves to home and set measurement to
pause and an alarm will be activated. Following actions can be performed during
interrupt:
Exit worklist: Press key ESC again:
Measurement and worklist will be aborted.
Move robotic: Press key LEFT/RIGHT:
Moves robotic to left or right home position, which allows access to

reagent rack or cuvette tower for reloading.
Contine worklist: Press key ENTER:
Continuous measurement
4.4 OUT OF LIQUID OR CUVETTE DURING MEASUREMENT

System will interrupt worklist automatically, if
Out of liquid:
Replace vial at indicated position within 30sec after

alarm and press ENTER to continue worklist. After
30sec system will exit worklist or skip order according
to setup of autoskip function.
Out of cuvette:
Reload cuvettes and press ENTER to continue worklist

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4.5 CONTINOUS LOADING OF SAMPLES
 This feature requires TECAM software.
(1) Samples without patient barcode
 Define new orders with TECAM software and send to instrument

 Goto instruments and press ESC and wait until robotic is idle
 Place patient samples into rack according to TECAM order sequence
(2) Samples with patient barcode
 Scan patient barcode. System will display rack position and barcode number
and interrupt current worklist.
 Wait until measurement is interrupted. Then place the tube into the required
rack position.
 Scan and place further samples
 press ENTER to continue worklist
 New PID are now visible at TECAM software. Add methods and send order to
instrument.
Do not access or move patient racks during operation of robotic. Always

interrupt measurement before loading reagent, cuvette or samples during
 measurement. Otherwise system can be damaged !

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4.6 MEASURING THE EMERGENCY SAMPLES

(1) Load new sample like descriped in chapter 4.5 .
(2) Define new order with TECAM and mark sample as “STAT” and send to instrument.
(3) The instrument will process all STAT orders as soon as possible.
FIGURE 12: EMERGENCY SAMPLES

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4.7 MEASURING THE SAMPLES IN MICRO TUBES

(1) Load new sample like descriped in chapter 4.5 .
(2) Define new order with TECAM and mark sample as “MICRO” and send to
instrument.
FIGURE 13: EMERGENCY SAMPLES
(3) The instrument will process the sample as micro volume
 Smallest possible tubes are 2mL Safe lock tubes (see figure)
 At least 100µL of sample is required
 Z-Offset of micro tube must be adjust within service menu

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4.8 QUALITY CONTROL MEASUREMENT
 TECAM PRO software is required for flexible QC-controlling including Levey-Jennings

graphics and Westgard rules.
QC with TECAM software: :

 Place quality control into cooled position CP1, CP2 or CP3 or use regular rack
position. Select correct position and click on “Edit”
FIGURE 14: QC SAMPLE
 Define the order as quality control and update the QC rangecontrol range in
the menu SETUP TEST
FIGURE 15: QC SAMPLE
 Send the QC order to instrument

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4.9 REFLEX TESTING
After worklist run, then instrument will validate results and repeat test under
following circumstances:
 Clot Reflex:
Test is repeated with additionally 60s prolonged maximum reading time, if no
clot was found (+++). This mode is only active for method “CLOT”.
 Unit Reflex
Test is repeated with half or double plasma dilution, if result is above or
below the unit reflex limits (see chapter 3.3.2 Units)3.3.2).
 Disable/Enable
Reflex testing can be enabled globally in analyser menu “ANALYSIS”
Unit reflex can be enabled for each test in analyser menu “SETUP TEST”.
Repeated results are flagged with “R”
4.10 DISPLAY DURING MEASUREMENT
WORKLIST IN PROCESS
PT result was found on measurement channel P01 and P02.
P01 PT 1.00 INR
aPTT is waiting for incubation time
P01 APTT /
P01 FIB x0045 FIB is under process.
P02 PT 1.250 INR
P02 APTT / Progress in the worklist is displayed in %. 100% means the
P03 FIB x0021
worklist has been completely processed.
PROGRESS: 6%
- HC - “LIS” indicates that the analyser is linked to HOST.
A rotating bar at the right edge of the screen indicates incubation (e.g. PTT) in the next
cuvette.
A rotating bar in front of a number indicates an ongoing measurement. The number is the
current light absorbance in mOD (milli optical density). A pronounced increase in light
absorption indicates a coagulation event!
While the message "CALIBRATE" is displayed, the COATRON A6 PLUS searches for the
optimum amplification parameters for the measurement channel.

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4.11 RESULT WARNING MESSAGES

Results may also be displayed with various additional warning symbols:
 * Result outside calibrated range
 A Result outside normal range
 T Temperature outside 36 – 38°C range
 Q Quality control outside control range
 C Result is identified as a quality control
 E Reagent is expired
 f Low Fibrinogen level found. Endsignal of PT is <75mE
 F High Fibrinogen level found. Endsignal of PT is >800mE
 R Result repeated ( reflex testing)
 ! Result not trustful and should be repeated.
 S External UV light too bright. Avoid sunlight or UV sources.
 X Double values deviate by more than 15%
 K Measurement skipped, because out of reagent
 SKP Job was skipped due to missing reagent or plasma
 RFX Job is repeated by reflex testing
 XXX No result was found
 SSS Signal transmission too low.
 +++ No coagulation determined within the
measurement time
 ??? Result based on strange optical signals (e.g. air bubble, peaks)

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5. MENU ANALYSIS
From main screen select “ANALYSIS”. Return to the previous screen with key
ESC.
Coatron A4 WORKLIST
1 NEW LIST
1 ANALYSIS 2 CONTINUE
2 SETUP TEST 3 REPEAT
4 STAT
3 SETUP SYSTEM 5 VIEW
4 SERVICE 6 PRINT OPTION
7 CUVETTE ACTIVATION
8 TEST ACTIVATION
12:00 1150mL H00 37.0°C
12:00 1055mL H0 37.0°C
menu analysis
5.1 SUBMENU NEW LIST YES
With ESC one returns to the previous screen.

Select CONTINUE = YES to come to the next screen.
Screen: worklist
CONTINUE: YES
TEST: PRFL
BARCODE: NO
RELFEX: NO
DOUBLE: NO
AUTOSKIP: NO
CLEAN: MIN
SHIELD: YES
MODE: CUV
 Test:
With ARROW  one proceeds to the list of all available tests in which
one navigates with the arrow keys, Enter selects the test from the
worklist. With Enter on the field INFO an overview of the test settings
is printed out.
 Barcode YES / NO:

Primary tubes are provided with barcode label, which is used to input
the patient identification number (PID)

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 Reflex YES / NO:

Activates reflex testing. The instrument can repeat automatically
suspected results like +++ (no clot detected) or greater. smaller a
certain limit (e.g. FIB > 600mg/dl).
 Double: YES / NO
Activates the double test. The mean value is automatically used in the
results report. If the two individual results differ by 15%, the result is
labelled Flag "%."
 Autoskip YES / NO:

The instrument will skip current job or test, if plasma or reagent runs
out and continue with the next order. Skipped jobs are printed as
“SKP”. Select “CONTINUE” in the analysis menu to re-run only skipped
jobs.
 CLEAN: Min - Max

Defines how to clean needle after pipetting samples
 MIN: Don’t perform a clean cycle from sample to sample. The

risk of sample to sample carryover was evaluated with extreme
high levels of Heparin and concerned low.
 MAX: Always perform a clean cycle from sample to sample. It

required much more Rinse solution and time to carry out a
worklis
 SHIELD: Yes - No
This setting is only display, if a protection shield is installed.
 YES: System stop immediately operation, if protection shield is

opened during worklist.
 No: Deactivate shield detection
Important:
Deactivated shield function may lead to injury and infections

cause by piercing needle.
 Mode: BAT / SEL / CUV / HS-1 / HS-2 / EV1 / QC

Determines the mode of test processing:
 Test Batch (BAT): Processes all similar tests in sequence (eg. all PT
, than all APTT, ..) Well-suited to time-optimized test processing in
routine operation, but complete patient reports are available
after end of worklist.
 Patient selective (SEL): Processes patients in sequence ( eg.
Patient 1, PT+APTT then next patient). Important:
Complete patient reports are available during run, but worklist
need more time and Rinse.

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 Cuvette Batch (CUV): This is a combination of BAT and SEL and

combines the best of both. ( eg. First cuvette PT, second cuvette
aPTT,…).
 Evaluation 1 (EV1): Regardless of how many samples were
entered, plasma is only taken from sample position 1. Well-suited
for determination of precision, consumption and throughput
volume.
 QC: This mode is used for quality issues during production of
service.
 HS-1: Allows the maximum throughput for PT testing
 HS-2: Allows the maximum throughput for 45 repeatition
 Mode EV1, QC, HS-2 are not suitable for routine processing and should used
only for research issues.

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Screen: Test Profil, Control plasma and Autoseries input:
CONTINUE: YES
SAMPLES: 45
INI.-ID: 1000
1: PT 2:APTT 3:FIB
4: - 5:- 6:-
7: - 8:-
Possible settings:
 Samples:
( only visible of barcode is set to no )
Manual input of number of samples.
 INI.-ID
( only visible of barcode is set to no )
Manual input of Identification Number for first sample. The other
samples were automatically incremented by 1 (1000, 1001, 1002,…..)
 Test 1 – 8:
When a profile is to be measured, you can define the individual tests
here once again.
 DFIB must be preformed together with PT, ACPR together with –APC and reverse;
LA-S together with LA-C and reverse
Ensure yourself that all reagents for profile can be placed on board. Otherwise the
profile will not operate correctly and lead to erratic results.

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Input of PID by barcode or manual entry:

(set BARCODE=YES , see screen 1 above)
In this screen you can enter the patient ident numbers by 3 ways:
RA CK 1
01 >>
02
03 Shift the racks separately at an even and moderate
04 speed in front of the barcode scanner. A signal tone is
05 heard for each recognized barcode
06
07
08 Use cursor keys to mark the current sample position
09 and scan the sample. Place the sample into current
10
11
rack position.
12
13 Use cursor keys to mark the current sample position
14
and enter manually the ID number and place the
15
sample into the rack.
 If a barcode was not recognized, check alignment and rescan. Read detailed information
in chapter “Barcode Guideline”
Press ENTER to come into the next screen.
SYCHRONIZE TO HOST
All patient identification numbers will be send to host.
PID: 1000 If the instrument is linked to host, it will receive

corresponding job orders.
|||||||||||||||||||||
In the next screen you can still revise the PID numbers and active tests, which are counted
upwards from the PID number of the first sample
POS PID 12345678 POS PID 12345678
P01 1000 xxx P01 1000 xxx

P02 1001 xxx P02 1001 xxx
P03 1002 xxx P03 1002 xxx
P04 1003 xxx P04 1003 xxx
P05 1004 xxx P05 1004 xxx
P06 1005 xxx P06 1005 xxx
1=PT 2=APTT 3=FIB 1=PT 2=APTT 3=FIB

3= - 4= - 5= - 3= - 4= - 5= -
6= - 7= - 8= - 6= - 7= - 8= -
 Select the order record with cursor keys UP/DOWN.

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 Select the order items PID or TESTS with cursor keys RIGHT.
 If a PID is highlighted, use numeric keys to change the number and confirm with
Enter.
 If a TEST is highlighted, use Enter to (de)activate. Use dot key “.” to (de)activate the
tests in all orders.
 To come to the next screen, use key RIGHT until the current order is completely
highlighted and press Enter.
Start worklist:
After worklist input is complete the requirement screen will appear. Check for
enough reagent placed on correct positions , check enough cuvettes and key
“ENTER” to start the measurement.
PREPARE SYSTEM
P46 800uL
o 800µl reagent in position 46=PT
P47 500uL o 500µl reagent in position 47=CACL
P49 500uL o 500µl reagent in position
P60 500uL
P79 740uL 49=Fibrinogen
o 500µl reagent in position 60=APTT
CUVETTES 3
o 740µl reagent in position 79=FIB buffer
CONTINUE >> KEY ENTER o 3 cuvette trays
 Use TECAM software to generate worklist in a much easier and flexible way
5.2 SUBMENU CONTINUE

Following a test interruption (e.g. due to a STAT task or discontinuation
due to a lack of liquid), routine measurement can be continued here.
5.3 SUBMENU REPEAT

Repeats the last worklist.

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5.4 SUBMENU STAT
Interrupts the regular processing of the list with key “ESC” and select this
menu.
STAT ENTRY
PID:
TEST: PT
INFO
MODE: MANUAL
CONTINUE: YES
 Input of PID:
Enter the Patient Identification Number (PID) manually or just scan it with
the barcode scanner. Enter terminates input of the PID.
Then place the emergency sample in the STAT position.
 Selection of the test:

With ARROW  one gets to test selection, ARROW  opens the list of
available tests; then use the navigation keys to select the test and return
to STAT INPUT with Enter.
 Information on the test:

Confirming the INFO field with Enter prints out the test setup just as in
normal measurement.
 Setting the mode:

If the mode is set to manual, the interrupted worklist must be continued
manually after the emergency sample has been measured. In the Auto
mode this is done automatically.
 Activation of emergency measurement:

Go to the field CONTINUE and confirm with YES.
The next screen SYSTEM PREPARATION displays the required position in
the reagent block, the required amount of reagent and the number of
cuvettes required.
After checking the reagent position, the measurement procedure can be
initiated with Enter.

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5.5 SUBMENU OVERVIEW

Displays and prints lists according to given sorting criteria.
WORKLIST
P01 1000
PT 70,1%
APTT 36,1s
FIB 398 mg/dL
P02 1001
PT 100,0%
APTT 33,5s
FIB 250 mg/dL
OPTIONS >> KEY ENTER
Enter calls up options, ARROW  / ARROW  pages through the options, Enter
executes the operation:
WORKLIST
P01 1000 1000

PT 70,1%
PRINT REPORT
SEND TO HOST
FIB 398 mg/dL
P02 1001
PT 100,0%
APTT 33,5s
FIB 250 mg/dL
OPTIONS >> KEY ENTER
The following options can be selected:

 Prints report
 Sends to host: Transmit the results from the processed worklist to a PC
for further processing. For this function you require the optional software
package "TECAM" or similar.

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5.6 SUBMENU PRINT OPTION
WORKLIST
1TEST
NEUE LISTE YES
SETUP:
2INFO:
FORTSETZEN YES
3PRINT DETAIL:
WIEDERHOLEN YES
PRINT REPORT: YES
4 STAT
5 UEBERSICHT
6 DRUCK OPTION
2003/01/01 12:00 37.0°C
Determines what information is to be printed automatically:

 Test Setup: YES / NO
The Test Setups are printed at the beginning
 Info: YES / NO
Information on worklist is printed at the beginning
 Print details: YES / NO
Detailed results are printed during the measurements
 Print report: YES / NO
A report is printed after the worklist is processed.

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5.7 SUBMENU CUVETTE ACTIVATION

This menu is only shown, if instrument is configarated as “Closed to cuvette”.
Read the barcode, which is provided with the cuvette package.
CUVETTE ACTIVATION
500 CUVETTES ENABLED
READ BARCODE
 Activation barcode can be read only one time and is be checked by serialnumber of
instrument.
5.8 SUBMENU SYSTEM ACTIVATION
This menu is only shown, if instrument is configarated as “Closed System”. Amount of

determinations must be activated by barcode. Read the activation barcode, which is
provided by the local distributor.
ACTIVATE SYSTEM
System will stop operation in 250
SYSTEM STOP IN determinations.
250 TESTS
READ BARCODE
ABORT >> KEY ESC
 Activation barcode can be read only one time and is be checked by serialnumber of
instrument.
 In case of barcode reading problems, press key “0” to activate manual input

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5.9 SUBMENU REAGENT ACTIVATION

A test must be activated by barcode , if the instrument is configured as closed to
specific reagent. The barcode is normally printed on the label of the vial. The activation
can be done in this separate menu or short before starting the worklist.
TEST ACTIVATION
PT: THROMBOPLASTIN
Activate reagent by scanning the barcodes of certain reagents.
POS=25 The activation is valid until next system reboot.
==================
CP=P35 50µL Reagent and test name is displayed as well as the test protocol
R2=P25 100µL
(e.g. control plasma at P35 with 50µL and R2=Diaplastin-E at P25
with 100µL)
12:00 1055mL H0 37.0°C
Barcodes will be rejected in case of

 invalid syntax of barcode
 date expired
 barcode differs to data stored in the SETUP test
 A new LOT must be first calibrated before it can be used within the Worklist. Refer to
chapter “TEST SETUP “
 In case of barcode reading problems, press key “0” to activate manual input

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6. MENU SETUP TEST
CHANGE TEST TEST: PT
PT DFIB APTT FIB LOT: 1234

AT TT DD HEP EXP: 12/2012
PC PS F2 F5 UNIT: %
F7 F8 F9 F10 INCUB: 60s
F11 F12 PLG -APC
APCR LA-S LA-C PSF
RUNTIME: 120s
XXXX XXXX XXXX PRFL REFLEX: YES
1=INFO 2=PRINT
ENTRY: AUTO
 1=INFO:
Show volumes and position of reagent
 2=PRINT:
Print test setup
 New lot number (LOT):
If the LOT number is inverted, ARROW  is used to get to selection of
individual digits, numbers and letters and ARROW  / ARROW  are used
to page through them; numbers can also be entered directly using the
numeric keypad.
 Input of expiry date (EXP.):
With ARROW  / ARROW  the month can be changed, with ARROW 
the year is changed analogously to the month. Expired dates will not be
accepted by the COATRON A6 PLUS
 Selection of unit:
With ARROW  / ARROW  the units are changed in which the results
are displayed with the exception of the basic unit (which depends on the
measurement principle). The available units are %, INR, Ratio, INR+ and
no further unit (-). Calibration curves can only be entered when a unit has
been selected. See chapter 3.3.2, Units on the significance and
calculation of the units.
 Incubation time
Define the delay time before start reagent (R2) is added.With ARROW 
/ ARROW  the incubation time is changed in 30-second increments
from 60 to 450 seconds.
 Runtime
Define the maximum reading time.
 Reflex
Enable/disable. Reflex testing will be automatically disabled , if no CLOT
and Unit reflex is possible. Unit limits can printed with “1:PRINT” during
test selection. For more information see chapter 4.9, Reflex testing
 Entry
Select between manual input of calibration curve or automatical test
calibration

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6.1 CALIBRATION CURVE
The analyser gives the operator the option to calibrate a test manually
(ENTRY=MANUAL) or automatically (ENTRY=AUTO).
 Manual Calibration:
The operator must prepare the standards and run them like normal
samples. He must also enter the results manually
 Auto Calibration with dilutions:

The operator must place the reference plasma into rack postion P01
and addionally empty vials in P02 – P06. The analyser will prepare all
required plasma dilutions, run the standards and transfer the results
into the calibration curve automatically.
 Auto Calibration with fix standards:

The operator can place upto 6 plasma standards into rack. The analyser
will run the standards and transfer the results into the calibration
curve automatically.
 Manual calibration
The operator must prepare the standards and run them like normal
samples. He must also enter the results manually
SETUP PT SET DATA: PT
TEST: PT
% s
1LOT:
TEST AUSWAHL
123456789
100 12,1
2 DATEN01/2004
EXP.:
EINGABE 50 16,2
UNIT: %
3INCUB.:
NORMALBEREICH
0s 25 25,7
4RUNTIME:
QC-BEREICH
120s 12,5 36,9
ENTRY: MANUAL 0 0
5 TEST DRUCKEN 0 0
12:00 1055mL H0 37.0°C R²=0.962
Select test and unit, set ENTRY to MANUAL and press ENTER.
The calibration curve can be entered or changed now manually. At least 2

value pairs are required upto a maximum of 6 value pairs. List navigation
is with the arrow keys and the values are confirmed with Enter. A value
pair can be added, deleted or changed at any position. Subsequent data
saving automatically sorts the calibration data.

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INR Calibration:
The operator can select the unit between

 INR = Ratio ISI (International Normal Ratio)
 INR+= INR calculated from a INR/sec reference curve
For UNIT=INR the operator must enter a normal value and the reagent ISI
value manually. If a PT % calibration is entered, the instrument will
calculate and display the 100% value. This value can be used as normal
value if there is no laboratory inhouse normal value.
The curve linearity is indicated with the regression factor R².

R² > 0.998 : the curve is linear.Two points are enough.
 R² < 0.950: the curve is inlinear. Use more than 2 points.
R² < 0.900: change math. model and use more than 5 points. Results outside of
calibration are not trustful.
The calibration data are checked for plausibility when they are saved. The following
rules must be complied with:
 At least 2 value pairs must be entered
 None of the value pairs may be entered double
  The values must be  0.
 The expiry date must be valid
An invalid “TEST SETUP” will be indicated with a long beep and rejected.

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 Auto calibration
The COATRON A6 PLUS prepares and measures all of the required

standard dilutions by itself and enters the mean values in the
calibration curve.
SETUP PT
STANDARD VALUE:
TEST: PT
1LOT:
TEST AUSWAHL
123456789 1 TEST
STD1: AUSWAHL
100 %
2EXP.:
DATEN01/2004
EINGABE 2 DATEN
STD2: EINGABE
0%
UNIT: % + INR STD3: 0%
3INCUB.:
NORMALBEREICH
0s 3 NORMALBEREICH
STD4: 0%
4RUNTIME:
QC-BEREICH
120s 4 QC-BEREICH
STD5: 0%
ENTRY: AUTO 5 TEST
STD6: DRUCKEN
5 TEST DRUCKEN 0%
12:00 1055mL H0 37.0°C
Select test and unit, set ENTRY to Auto and press ENTER.
 Autocalibration with serial dilutions
The dilutions are always prepared in following way:

1 2 3 4 5 6
1:1 1:2 1:4 1:8 1:16 1:96
1. Enter the calibrator target value in the field "STD1," e.g. 100%
for PT calibration, and confirm with Enter.
2. Enter the calibrator in position 1 of the sample rack.
ANALYSE CURVE
<- START
TEST: F8
SAMPLES: 06
DOUBLE: YES
QC-ACTIVE: NO
12:00 1055mL H0 37.0°C
6 standards are measured for factor VIII calibration. Therefore the calibrator
must be placed in rack position 1and 5 other empty sample test tubes are
required in rack positions 2-6, in which the COATRON A6 PLUS then prepares the
necessary dilutions.
3. Additional empty sample test tubes are required in rack

positions 2-6. The number of samples corresponds to the
number of sample test tubes and depends on the particular
test.
4. Select START, check the reagents and numbers of cuvettes
required in the screen SYSTEM PREPARATION and initiate the
measurement procedure with Enter.
 Autocalibration with fixed levels

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Enter more than one standard value in the fields STD1 – STD6.
Enter a reference value. Confirm with ENTER. Select next standard
field with key DOWN or press ENTER again to proceed with
calibration.
SETUP PT ANALYSE CURVE

STANDARD VALUE: <- START
TEST: PT
1LOT:
TEST AUSWAHL
123456789 1 TEST
STD1: AUSWAHL
1.00 INR
2 DATEN01/2004
EXP.:
EINGABE 2 DATEN
STD2: EINGABE
2.50 INR TEST: PT
UNIT: INR+
3INCUB.:
NORMALBEREICH STD3: 4.00 INR
3 NORMALBEREICH SAMPLES: 03
0s
STD4: 0.00 INR
4RUNTIME:
QC-BEREICH120s 4 QC-BEREICH
STD5: 0.00 INR
DOUBLE: YES
5ENTRY: AUTO
TEST DRUCKEN 5 TEST
STD6: DRUCKEN
0.00 INR QC-ACTIVE: NO
12:00 1055mL H0 37.0°C
12:00 1055mL H0 37.0°C
3 fixed standard levels are measured for PT INR calibration. Place INR calibration
plasma STD1,2,3 into rack position P01,02 and 03.
6.2 REAGENT BARCODE ENTRY
Scan barcode of reagent during menu “SETUP TEST”.
Test selection, lotnumber and expiry date will be input automatically by

barcode information. Barcodes will be rejected if reagent is expired.
6.3 STORING OF TEST DATA

Press ESC to return to the main menu “TEST SETUP”. If any data was changed,
the COATRON A6 PLUS will ask for confirmation before storing.
The test data are checked for plausibility when they are saved.
The following rules must be complied with:

 The calibration curve must be valid
 The LOT-Number must be in conformitity with TECO
 The expiry date must be valid

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6.4 SUBMENU TEST PRINTOUT
During test selection press key “1”
SETUP FIB
LOT: 302501299 - lot number

NAME: Fibronogen - reagent name
EXP: 1/2015 - expiry date
LAST CHANGE: 03.04.2013 - date of input
_______________________________
1: 80 mg/dl - 27.0 s
2: 120 mg/dl - 18.0 s - calibration values
3: 240 mg/dl - 12.0 s
4: 480 mg/dl - 7.0 s
_______________________________
R² = 0,992 - Linearity of the calibration curve
(1.000 for a straight line)
( R² should be 0.850 – 1.000)
S-CORR: 0% -signal correction

T-CORR: 0% 0s -time correction
START: 3s -deadtime
INCUB.: 120s -incubation time
RUNTIME: 120s -max. runtime
METHOD: COAG -test method=coagulation
CT-MECH: NO -clottingtime mechanical=no
SENS: 0 -test sensitivity=low
MIX: 0 -reagent mixing=no
CLEAN: 1 -high cleaning cycle=yes
MULTI: 1 -multi dispensing=Yes
BARCODE: 1 -barcode required=yes
REFLEX: >600mg/dL -unit reflex=yes, if result>600mg/dL
PAT: VOL= 10uL POS=62 (CP) - 10µl Sample

BUF: VOL= 90uL POS=78 - 90µL IBS from Pos=P78
CLR: VOL= 0uL
DEF: VOL= 90uL POS=0
R0 : VOL= 0uL POS=0
R1 : VOL= 0uL POS=0
R2 : VOL= 50uL POS=49 - 50µL reagent from POS=P49

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7. MENU SYSTEM SETUP
System Setup is used to for basic device settings that are normally only rarely changed.
SYSTEM SETUP General operation:

ARROW / left column Change item
LANGUAGE:
LANGUAGE: ENGLISH
DATE: 2003/01/01 ARROW  change to right column
TIME: 14:59:05
SIGNAL: ON ARROW / right column: Change value
CONTRAST: 225
Enter to confirm the value.
MIXER: 200
SIMULATOR: 0
ESC exit menu
VMAX: N
SHIELD: ON
COOLING: HI
7.1 LANGUAGE
Select between:English - Italian - Spanish - German
7.2 DATE
The date format is changed in change mode with ARROW  / ARROW :
 European date format (DD.MM.YYYY)
 American date format (YYYY/MM/DD)
Use Enter to get into change mode for day, month and year, use ARROW  /
ARROW  to change the date elements (day, month, year).
7.3 TIME
Use Enter to get into change mode for hours, minutes and seconds, use
ARROW  / ARROW  to change the time elements (hours, minutes and
seconds).
7.4 SIGNAL
Switches the acoustic signal on or off.
Possible settings:
 Signal on
 Signal off

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7.5 CONTRAST
Changes screen image contrast.
Continuous settings from 214 to 255; the result can be checked on the screen
without delay.
7.6 MIXER
Changes the magnetic stirrer speed at position 25 in the reagent block.
Continuous settings from 0 to 255, standard setting 200.
7.7 SIMULATOR
Facilitates simulation of measurement operation without moving the pipetting
arm.
 Simulator = 0:
Normal operation; simulator is not active
 Simulator = 1:
Maintenance operation; commands issued to the XYZ robot are not
executed. System functions as usual otherwise. This mode is very helpful
for maintenance work or while familiarizing oneself with the system.
 Simulator = 2:
Demonstration operation; Remove all vials and containers. Add oje
cuvette into system and run any worklist. Instrument will simulate
levelsensing and reaction curve.
7.8 SHIELD
The robotics will not move, if shield is opened.You can deactivate this
protection.
Deactivated shield function may lead to injury and infections

cause by piercing needle.
7.9 COOLING
Select between high (~12°C) and low. ( ~16°).
Mode “low” should be set, if high condensation is observed on the cooling

block or if reagent block-2 (POS 70 – 75) will heat up over 40°C.

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8. MENU SERVICE
SERVICE
1 PRINT REPORT
2 ADJUST XYZ
3 ADJUST TEMPERATURE
4 CHECK OPTIC
5 CHECK ROBOTICS
6 MOVE CUVETTES
7 CLEAN NEEDLE
8 REPLACE RINSE TANK
9 ADJUST MOTOR
10 MICROTUBE
ARROW / the desired menu item is selected

Enter initiates the operation directly.
1-9 select item directly

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8.1 REFILL CUVETTES
1. Remove a strip of cuvettes from the

package.
2. Shift the cuvettes as shown from above in
the guide groove back into the cuvette
tower.
3. Remove the tape off the cuvettes.
FIGURE 16: INSTALLATION OF CUVETTES
 Cuvettes are disposable items. Washing and re-use is not permitted for reasons related
to hygiene and accuracy
8.2 INSERT PRINTER PAPER
FIGURE 17: INSTALLATION OF PRINTER PAPER
1. Open the printer cover as shown.

2. Input new paper and close cover.

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8.3 SYSTEM REPORT

Printout of important system data
SYSTEM - REPORT
DATE: 2012/25/10 13:59
SYSTEM: COATRON A6 PLUS

SERIAL NO.: 1234567
SOFTWARE: 01.00.02
OPTIC 1: 80 30005 (162) OPTICS : 80 30005 (162)

OPTIC 2: 62 29984 (169)
OPTIC 3: 85 29766 (153) 80 = Digital value when LED is off
OPTIC 4: 50 29793 (165) 30005 = Digital value when LED is on
OPTIC 5: 50 29722 (135) 162 = Amplification factor
OPTIC 6: 50 29768 (144)
TEMPERATURE MESS:39.2 °C (39.0) Temperature cuvette: current celsius (target)

34968 (34970) current digits (target)
TEMPERATURE HEAT:37.1 °C (37.0) Temperature reagent PT:current celsius (target)

34395 (34398 current digits (target)
CONTRAST: 225 Display contrast

MIXER: 200 Reagent mixing speed
-----------WASH REAG CUV PAT Needle Position for Wash , Reagent,Cuvette & Patient
OFFSET X: 1 -2 0 0 X-Offset = left/right
OFFSET Y: 3 1 0 -5 Y-Offset = forward/backward
OFFSET Z: 0 1 0 1020 Z-Offset = up/down
OFFSET M: 4 Motor Adjustment: Offset=4
RINSE INSTALLED: 108 ml Remaining system liquid

NEEDLE TIMER: 9212 Tests Age of needle: number of performed tests
SYRINGE TIMER: 33421 Age of syringe: number of up/down cycles
STOP-STOP IN: 905 TESTS Remaining determination before system stop
SERVICE IN 58001 TESTS Next service required in
PT COUNTER: 344 Number of carried out tests for counted

PTT COUNTER: 6 PT,PTT,FIB or all tests
FIB COUNTER: 302
ANALYSIS COUNTER: 1079
---- SYSTEM STATUS --- System requires a barcode to run tests

SYSTEM = CLOSE System requires a barcode to reset service interval
SERVICE = CLOSE System requires a barcode before use of reagent
REAGENT = CLOSE

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8.4 ADJUST XYZ
Key 4/6 move needle left/right (X-offset)

Key 2/8 move needle backward/forward (Y-offset)
ARROW / move needle up/down ( Z-offset)
ENTER goto next position
ESC exit adjustment
Five positions must be adjusted

 Wash postion
 Clean position
 Cuvette position
 Patient position
 Cap piercing height
optimum wash optimum reagent optimum patient optimum piercing
Preparation:
Ensure yourself, that the needle is straight and correct mounted 105mm in
length. For correct z-offset adjustment following tubes or vials must be
placed
POS Container
P01 Patient-1 primary tube
P80 CLEAN-A CLEAN-A solution
- Cuvette1 empty cuvette

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Confirm with “YES” to start adjustment
1. Needle will go to wash position. Center the needle exactly. The needle tip
must be at same level with top of wash position. Press “ENTER” to come to
next postion or press “ESC” to quit.
2. Needle will go to P80. Center the needle.The needle tip should be short
before touching the vial buttom. Lift vial to determine the distance. Press
“ENTER” to come to next postionen or press “ESC” to quit.
3. Needle will go to cuvette position. Center the needle exactly to cuvette and
press “ENTER” to forward or “ESC” to quit.
4. Needle will go into air. Remove the optical protection shield, if installed
and press “ENTER” to adjust z-offset of cuvette position.
5. Needle will go down into cuvette position. Adjust z-offset until needle is
short before touching the cuvette buttom. Press “ENTER” to come to next
position or press “ESC” to quit.
6. Needle will go to sample position P01. Center the needle.The needle tip
should be short before touching the vial buttom. Lift vial to determine the
distance. Press “ENTER” to come to next postionen or press “ESC” to quit.
To avoid needle crash the z-offset is set to default, before the needle
drives to this position. So even if you didn’t change the offset, the z-
position must be re-adjusted anytime

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8.5 CHECK TEMPERATURE
Temperature CV Temperature around measurement cuvette.

Temperature PT Temperature at reagent position PT ( P25 )
(xx) Target temperature in degrees Celsius
xx,x Current temperature
Setting the temperature:
With ARROW  /  the current temperature is changed in 0.1°C increments.

Enter selects the temperature ESC returns to the service menu.
1. Place an empty cuvette in the measuring cell and fill 300 µl water into all
of the 6 measurement positions. Place a standard commercial fever
thermometer in one of the cuvette wells. Make sure the cuvette is
standing upright.
2. Place also an empty reagent container in position "PT" (P25) and fill with 6
- 7 ml water. Place a standard commercial digital fever thermometer in
the water.
3. On the keyboard the green Temp. LED should light up.
4. Wait for at least 15 minutes. Now read off the temperature on the
Thermometer.
5. The temperature should be in the range of +-0.5°C of target temperature.
Use ARROW  /  to change.
6. Adjust temperature so often until the temperature shown on display
matches the temperature in the cuvette or PT position.
7. For“PT” also the target temperature can be adjusted. Lower storage
temperature of reagents will significantly increase stability, while results
will be nearly unchanged.
 Please ask local distributor about change of reagent target temperature

o

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8.6 CHECK OPTICS

Remove the cuvette in the measurement optics.
CHECK OPTIK
OFF ON AMP
1= 78 29851 185
2= 105 29624 192
3= 56 29799 171
4= 78 29851 185
5= 98 29245 155
6= 110 29967 145
T1=34302 (34310)
T2=34081 (34081)
T3=31707 (31800)
SENS: 1-1-0-0
X= Measurement channel 1-6

OFF Digital value when LED is off. Target range <500
ON Digital value when LED is on. Target range 28000 - 32000
AMP Signal amplification, Target range 150 - 300
T1 Digital value heat area, Target range 33000 - 36000
T2 Digital value cuvette area, Target range 33500 – 36000
T3 Digital value cool area
Sensor: cuvette- shield rinsetank wastetank
0=empty 0=opened 0=full 0=empty
 Please contact customer service if the values deviated from the target values
8.7 CHECK ROBOT

To check, if XYZ, pump and level sensor is working. Press ESC to abort this test.
It is used for service and quality issues. Remove all vials and tubes before
continue. Print “FALSE LEVEL” indicates that level detector stops false in air. In
this case the insulation block must be replaced.
8.8 MOVE CUVETTES

Turns cuvette rotor for transport of cuvettes until Enter is pressed. It is used to
empty the cuvette tower.
8.9 CLEAN NEEDLE

Carries out an intensive needle cleaning cycle. It is used after needle is
complete and partial clogged during measurement.
8.10 REPLACE RINSE TANK

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Barcode activation is only shown if instrument is closed to Rinse solution. Read

the barcode, which is provided with the cuvette package.
RINSE TANK ACTIVATION
1 RINSE TANK ENABLED

( VOL = 120mL)
READ BARCODE
The current numbers of remaining Rinse tanks and installed volume of

Rinse solution is displayed. The message can be ignored with key “ENTER”,
but latest at zero value new Rinse tanks must be activated by barcode.
1. Remove the full waste tank (located in the drawer or trolley) and
dispose it according to regulations for infectious material
2. Replace the empty rinsing tank with a full one. Ensure that the tube is
insert completely into the tank.
3. Use the empty Rinse tank as new waste tank !
4. Run menu “SERVICE\REPLACE RINSE TANK”to reset the Rinse counter
5. If zero tanks are enabled, scan the barcode of the certificate, which is
included to each new box of Rinse tanks.
 The Rinse tank activation barcode can be used only 1x time.
 Make sure a full tank is really installed, since otherwise the COATRON A6 PLUS will
calculate the consumption incorrectly.
The full liquid waste tank may contain infectious substances and must be handled
and disposed of as infectious waste. Always wear gloves for infection protection
when replacing the liquid waste tank! After this procedure, disinfect your hands
with a hand disinfectant, e.g. Sterilium®.

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8.11 ADJUST MOTOR

Changes the assignment of the cuvette to the measuring position. The cuvette
must be positioned exactly centered to the optic, to ensure accurate results.
Fill some water into a container and color the water with a green lightning pen.
Remove all cuvettes onboard. Add 150µL green colored water into every
cuvette position and place it into position prewarm. Run menu “ADJUST
MOTOR”. The system moves now cuvette into optics. If the light beams are not
centered, change the offset value, move cuvette back and repeat the
procedure until correct adjustment of the cuvette position.
The factory default value is „8“ . An increase of the offset will shift the cuvette
to the left.
False adjustment will cause errorneous results.
8.12 MICROTUBE
Adjust the height of micro tubes.
 Pipet 100µL water into an empty micro tube

 place the tube into rack P02.
 Press ENTER to continue.
 Z-axis drives to default 500
 Lower needle with key DOWN until tip get in contact with micro tube
 Press ENTER to check level sensor
 Press ESC to save and exit
How to use micro tubes in routine measurement is explained in chapter 4.7

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8.13 INIT SYSTEM

 Switch off instrument.
 Presse key “0” and keep it pressed
 Switch on instrument.
Following screen is displayed
0 EXIT
1 INIT TESTS
2 INIT ALL
3 RESET SERVICE
 EXIT
Return to system bootup
 INIT TESTS
Reset all calibration data ( lot,exp,calibration curve,,) to zero
Reset all protocol data ( regent volumes,position) to default
 INIT ALL
Include init tests and additional
Reset all system parameter (contrast, language,…) to default
 RESET SERVICE
Clear service warning and set interval to next 50.000 tests
8.14 RESET SERVICE INTERVAL
After 50.000 tests the message “SERVICE” will be shown.
To reset service interval:
 Switch off instrument.

 Press key “0” and keep it pressed
 Switch on instrument.
 Wait until init screen is displayed
 Select “RESET SERVICE”
Form more information see chapter 8.13 I

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9. MENU PIPET STATION
Menu to reconstitute reagent and controls
PIPET STATION
IN: P75
OUT: P74
TOTAL: 0 ul
VOL (uL): 1000
PIPET >> KEY ENTER

ABORT >> KEY ESC
Fill enough diluent into container and place it to position P75. Open reagent vial
and place it to position P74. Change volume with keys UP/DOWN and press
ENTER to dispense diluent into reagent vial. Press ENTER again if more diluent is
required. The total volume will be updated with each pipeting step. Press ESC to
reset total counter and perss ESC again to exit menu.

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10. CLEANING AND MAINTENANCE
Cleanung and maintenance must be performed on a regular basis in order to maintain

accuracy and precision. The schedule below outlines the proper intervals to check or replace
components of the instrument.
10.1 GENERAL CLEANING INFORMATION

 Use detergent and water and 10% diluted bleach or commercial decontaminant
for daily cleaning
 Use 30% diluted bleach and commercial disinfectant ( e.g. Bacillol®AF) for
weekly decontamination
 Clean with a lint free cotton cloth or stick
 Never pure any liquid into optic or working area
 Keep the device free of dust and moisture.
 If the device is soiled with liquids, remove the soiling with an absorbent cloth.
 If a liquid has accidentally been spilt or pipetted into a measurement channel,
remove it immediately with a pipette and clean the measurement channel with a
lint-free cloth. Check the function of the optics in the menu SERVICE
Regard all surfaces and materials which might be in contact with plasma
or other biological liquid as potentially contaminated with infectious
material.
Avoid any direct contact with decontaminants or disinfections.
10.1 CLEANING
 Use detergent and water and 10% diluted bleach or commercial decontaminant
 Clean and wipe up all spills around the working area or needle pump system with
detergent and water.
10.2 DECONTAMINATION
 Use 30% diluted bleach and commercial disinfectant (e.g. Bacillol®AF)
 Decontaminate working area, needle area, patient racks, keyboard, LCD screen,
front casings, printer and waste drawers

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10.3 DAILY ACTIVITIES

 Clean system with detergent and bleach as described above
 Inspect level of Rinse and waste container
 Empty cuvette drawer and fill tower
 Inspect tube system for any leaks and correct immediately
10.4 WEEKLY ACTIVITIES

 Decontaminate system with bleach and ethanol as described above
10.5 YEARLY ACTIVITIES

 Clean and decontaminate equipment
 A yearly service check according to TECO test specification QMV-07-10 must be
carried out by the authorized and qualified technician
10.6 REGULAR REPLACEMENTS

Every 100.000 tests following parts must be replaced
1. Replace needle
2. Replace syringe seal
3. Replace tubing
4. Replace insulation block
5. Replace cleaning position
6. After 5 year replace battery of the mainboard (Li-Mn CR 2430)

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11. ELIMINATION OF MALFUNCTIONS
11.1 ERROR MESSAGES

Error message Possible cause Action
Service Service interval is expired Service instrument and reset
after 100.000 tests interval with barcode certificate.
Activate System System interval is expired Scan barcode “Test Activation Key”
Activate Reagent Reagent mut be validated Refill cuvettes
Error pump Needle clogged Check needle and tube system
Diluter valve defective Replace valve
Error robot No connection to robotic Consult the customer service of

your dealer
(system error 2-28)
Needle crash Reboot the system
Fill cuvette tower Cuvette tower empty Refill cuvettes
Adjust XYZ Replacement of needle XYZ adjustment of pipetting arm
Adjust Motor Replacement of main-board or adjustment of cuvette

software update
No liquid No liquid in current position of Refill liquid at current needle

pipetting needle position.
Z-offset false XYZ adjustment of pipetting arm
Check printer No printer paper Replenish printer paper
Arresting lever in offline Change arresting lever position

position
No printer connected Consult customer service
Check temperature Temperature in system block Check temperature and adjust

too high or too low
Clean needle Pipetting needle was replaced Carry out needle cleaning cycle
Check waste Every 80 cuvette or every new Check cuvette waste drawer and
Rinse tank the instrument do also Rinse waste tank. Then just
a reminder to check also the confirm message.
waste.

TECO GmbH
11.2 DEVICE MALFUNCTIONS
Malfunction / Error Possible cause Measures

No print on printout Paper installed in wrong Turn paper roll around
position
Needle does not pipette Tube system leaky Replace the tube system
correct volume
Level sensor defective Replace insulationblock
Needle clogged Place the needle in

COATRON A6 PLUS Cleaner
for 30 min, then run the
wash cycle.
Poor reproducibility Needle-tube system Replace the needle, tube
system ,syringe or valve.
Motor is not adjusted Check the adjustment of the

cuvette to the optic
Cuvette assumes false position Wrong cuvette Use only original COATRON
A6 PLUS cuvettes
Motor is not adjusted Check the adjustment of the
cuvette to the optic
Defective cuvette motor or Consult customer service of

microswitch for cuvette your dealer
recognition
Optics not within target value Cuvette is in measurement Remove the cuvette and
range position during optics check repeat the optics check
Soiling or liquid in Optics must be cleaned.

measurement channel Consult customer service
LED does not light up. Customer service will replace
optics

TECO GmbH
11.3 MEASUREMENT MALFUNCTIONS
Malfunction / Error Possible cause Measures

Results flagged "*" Result outside calibration
range
Flagged "A" Result outside normal range
Flagged "T" Temperature outside 36 – 38°C
range
Flagged "E" Reagent is expired
Flagged "Q" Quality control outside control
range
Flagged "S" Enviremont light too bright (
low >750digits) Avoid direct sunlight or
other UV sources
Flagged “f” or"F" Low or High fibrinogen.
(only test PT)
Run test FIB to confirm.
Flagged "R" Result repeated. Max. Runtime
too short or problems with
level sensor
Flagged "!" Result not trustful.
(only test DD) Dilute sample and repeat.
Flagged "X" Double values deviate by more
than 15%
Flagged "+++" No coagulation seen with
measurement time
Flagged "???" Coagulation time
indeterminate; course of
reaction does not correspond
to the criteria of the evaluation
algorithm (e.g. turbidity due to
air bubbles or coagulation
begins before dead time)
Flagged "SSS" Low signal. Light transmission Check optics
is not enough.
Flagged "K" Sample, Test is skipped
because out of reagent.

TECO GmbH
12. APPENDIX
12.1 TECHNICAL DATA

Analyzer
Measurement system 6 independent measurement channels
wavelength of LED 400 nm
Measurement timer Max. 540 s, error < 0.1 s
Cuvette 6 channel cuvette for optical detection
capacity: 75 – 750 µl
Calibration Automatic calibration or manual input of up
to a max. of 6 calibration curve points for
each test method
Positions 18 reagent positions at 36.5 – 37.5 °C
12 reagent positions at 12.0 – 16.0°C
6 park positions, preheating ( 33-38°C)
3x15 sampe primary tubes
1 emergency STAT positions
Reaction volumes Minimum total volume is 75 µl
Approvals The analyzer is conform to 98/79/EC (IVDD)
XYZ Robotics
Movement XY + Dual-Z
Level Sensor Yes. Detection limit is 100µL or 5% of vial.
Needle -Capacity for 450 µL
-Inner nanoskin coating
-Livetime for 100000 determination
Pump 2500 µl syringe with 300 step resolution
Lifetime of syringe is 100000 determination
imprecision 15% at 3µL
5% at 5µL
1% > 10µl

TECO GmbH
Barcode scanner
Laserclass 2 – EN60825-1:2007
max. power = 1.7 mW

pulse period = 420 µs
wavelength = 655 nm
Accepted codec Code 39, Codabar, Interleaved 2 of 5, Code

128 , EAN 128 and Code 93
Power supply
Nominal Input Voltage 100 – 240VAC at 45 – 63Hz
Maximal Input Current 5A rms
Output Power Max. 300 W
Socket Class-1
Approvals EN 60950-1, UL 60950-1
IEC 60950-1, EN 60601-1
CSA 22.2 No. 60950-1
2006/95/EC & 2011/65/EU
Dimensions
Size (W x D x H) 900 x 520 x 700 mm
Weight approx. 65 kg
Required space on table 1200 x 800 x 1000mm
Distance rear to wall 200mm
Ambient conditions
Operating Temperature 15 to 30 °C
Humidity < 70% rel. humidity
Elevation above NN sea level < 3,000m
Free of dust Grade 2
Impact resistance according to IEC/EN 61010-1, 8.2.2
Not allowed Vibrations, direct sun light; direct exposure
of air condition.
Noise output
Operating noise max. 65 dBA
Graphic user interface / software

Interface RS 232 (serial interface) for commu-
nication with PC for software updates,
service functions, PC evaluation
LCD display 128 x 128 items, 70 x 70 mm
backlit, adjustable contrast
Language German,English,Italian,Spanish

TECO GmbH
Specimen Collection
analyte Fresh or frozen human plasma;
Use within 4 hours
centrifugation 1500g x 10-15 min
anticoagulant Sodium citrate 3.2% (0.105M)
Mix 1 part citrate with 9 part venous blood

max. bilirubin concentration 50 mg/dL
max. hemoglobin concentration 2000 mg/L
max. triglyceride concentration 5000 mg/dL
Typical performance data

Test CV. Range
PT <3% 0-30INR
APTT <3% 15 – 420s
FIB <7% 50-999mg/dL
 Contact local distributor or manufacturer for detailed performance data

(throughput, consumption, precision and accuracy.

TECO GmbH
12.2 TRANSPORT AND STORAGE

Storage and transport temperature: 0 to 50°C
Size on palette (W x D x H) 1000 x 630 x 920 mm
Weight with palette approx. 80 kg
Box the device always into original packaging prior transport or longtime storage.If the
original packaging is no longer available, contact your dealer.
1. Remove the power cord from the socket and from the analyzer.
2. Decontaminate the complete equipment and confirm with a decontamination
certificate
3. Immobilize all moving parts such as sample racks printer shaft, etc. with tape.
4. Remove the needles and place them in the drawer for the waste tank.
5. Fix the robot in the resting position (seen from the frontright, rear) with tape
or cable binders to the protective bar.
6. Wrap plastic foil around analyzer
7. Push the analyzer to the edge of the table; then two persons must lift it by the
short sides.
8. Lift the analyzer carefully into the packaging.
9. Add accessory and required information and close box.
 Complete address of owner.
 Name of dealer from whom the Analyzer was purchased.
 Exact designation of the Analyzer and serial number (on type plate).
 Decontamination certificate
 A useful description of the reason why the equipment is being sent in (error
/ malfunction description).
12.3 DISPOSAL AND RECYCLING

The instrument is be subject to European Directive 2002/96/EC (WEEE). Contact
your local distributor the assistance
 The housing is made of polystyrene.

 The mechanical parts are mainly aluminium.
 Electronic parts must be disposed of in accordance with currently valid
regulations for their disposal.
Warning! The equipment must be decontamination prior any disposal or

transport to an authorized electronic waste processing site.

TECO GmbH
12.4 BARCODE GUIDELINE
Specification of label:
- Label length: 50 – 70 mm
- Label height: 20 - 30 mm
- Barcode length: 40 – 60 mm
- Barcode height: 10 - 20 mm
- Quiet zone: >5mm
- Resolution/module: 8 -20mils (0.2 – 0.5mm)
- Ratio: min. 1:2,5 to 1:3 (two dimensional codes)
- Quality Level A or B according to ANSI X3.192 -1990
Accepted codes:
- Code 128 3 – 16 characters, use checksum without show
- EAN 128 3 – 13 characters, use checksum without show
- Code 39 4 – 13 characters, no checksum
- Code 93 4 – 13 characters, no checksum
- 2/5 interleaved 8 - 12 characters, no checksum

TECO GmbH
13. INDEX
ACTIVATE REAGENT ....................... 56 flag ‘SSS’ ........................................ 45, 80 QC ........................................................... 47
ACTIVATE SYSTEM........................... 55 flag ‘T’ ............................................ 45, 80 Quality control .................................... 43
Adjust Motor ......................... 73, 78, 79 flag ‘X’ ............................................ 45, 80 Range...................................................... 83
Adjust XYZ............................................ 68 flag ‘XXX’ ............................................... 45 reagent probe...................................... 23
Ambient conditions .......................... 82 Flag , summary.................................... 45 REAGENTS Positions ........................ 24
Analysis ................................................. 46 Hemoglobin...................................... 9, 83 Rear view ....................................... 23, 24
Anticoagulant...................................... 83 Host ................................................. 28, 50 Recycling ............................................... 84
Approvals ............................................. 81 HS-1 ......................................................... 47 Reflex Testing ............... 29, 44, 47, 57
Autoskip......................................... 39, 47 HS-2 ......................................................... 47 Regulatorys .......................................... 81
Barcode ................................... 46, 50, 61 Immunoturbidimetric ...................... 31 Report of system ................................ 67
Barcode for Rinse tank.................... 72 Imprecision .................................. 81, 83 Report of test....................................... 62
Barcode Scanner......................... 23, 82 Incubation time .................................. 57 reproducibility.................................... 79
BAT ......................................................... 47 Infection ................................................ 10 Requirement screen ......................... 51
Bilirubin ............................................ 9, 83 Infectious Material ............................ 10 RESET SERVICE .................................. 74
Calibration .............. 57, 58, 59, 60, 81 Info .......................................................... 57 RINSE ..................................................... 23
Calibration curve ............................... 58 INIT ......................................................... 74 Robot ...................................................... 71
Centrifugation .................................... 83 INR ........................................................... 29 Runtime ................................................. 57
Clean....................................................... 47 INR+ ........................................................ 29 Safety information ................ 9, 10, 11
CLEAN-A ............................................... 26 Installation ................................... 21, 66 sample probe....................................... 23
CLEANING ............................................ 76 Intended Use.......................................... 9 Scope of delivery................................ 15
Clotting .................................................. 30 Interrupt worklist.............................. 39 Screen.............................................. 23, 28
Contrast ................................................ 64 Interruption ......................................... 40 SEL........................................................... 47
Control measurement ........................ 9 ISI ........................................................... 29 Serial-No. .............................................. 84
COOLING ............................................... 64 Keypad ....................................... 8, 18, 27 Setup System ....................................... 63
CP1 .......................................................... 43 Kinetic .................................................... 31 SETUP TEST ......................................... 57
CP2 .......................................................... 43 Language ............................................... 63 Shield....................................... 23, 47, 64
CP3 .......................................................... 43 Laser ....................................................... 10 Signal ...................................................... 63
CUV ......................................................... 47 Laserclass.............................................. 82 Simulator .............................................. 64
Cuvette .................................... 66, 71, 81 LIS ........................................................... 44 Single factor measurements .......... 22
CUVETTE activation ......................... 55 Lot No. .................................................... 57 SKP ........................................... 45, 47, 80
Cuvette rotor....................................... 23 Main Menu ............................................ 33 Start worklist ...................................... 51
Cuvette tower .............................. 23, 66 Maintenance ........................................ 76 STAT ................................................ 41, 51
Date ........................................................ 63 Mean ....................................................... 47 Storage ................................................... 84
Decontamination ........................ 11, 76 Measurement principle ................... 28 switchin on/off ................................... 17
DFIB ........................................................ 30 measurement screen ........................ 44 Symbols .................................................... 8
Disposal................................................. 84 Measurement start ............................ 38 SYNCHRONIZE .................................... 50
Error messages .................................. 78 Microtube...................................... 42, 73 System block........................................ 23
EV1.......................................................... 47 Mixer ....................................................... 64 System status ...................................... 28
Exp. ......................................................... 57 mOD ........................................................ 44 Tank ........................................................ 71
Factroy reset ....................................... 74 Needle .................................................... 71 Tecam ...................................... 24, 40, 43
Fibrinogen............................................ 22 Optic ........................................................ 71 TECAM ............................................ 20, 51
flag ‘!’ ..................................................... 80 ORDER.................................................... 50 Test Activation.................................... 56
flag ‘*’ ............................................. 45, 80 Out of cuvette ...................................... 39 Test overview...................................... 32
flag ‘???’ ................................................ 80 Out of liquid ......................................... 39 Thrombin .............................................. 30
flag ‘+++’ ....................................... 45, 80 OVER view ............................................ 23 Thrombin Time .................................. 22
flag ‘A’ ............................................ 45, 80 Package .................................................. 66 Throughput ................................... 48, 83
flag ‘C’.................................................... 45 PID ............................................ 46, 49, 50 Time ........................................................ 63
flag ‘E’............................................. 45, 80 Pipet Station......................................... 33 Transport .............................................. 84
flag ‘f’ ..................................................... 80 PIPET STATION .................................. 75 Triglyceride ..................................... 9, 83
flag ‘F’ ............................................. 45, 80 Pipetting arm ......................................... 9 Type plate ............................................. 84
flag ‘I’ ..................................................... 45 Precision................................................ 48 Units........................................................ 29
flag ‘K’ ..................................... 45, 47, 80 PRFL ........................................................ 49 Warm-up time..................................... 18
flag ‘Q’ ............................................ 45, 80 Print out......................................... 62, 67 Warranty............................................... 21
flag ‘R’ ..................................... 44, 45, 80 Print test................................................ 57 Wavelength .......................................... 81
flag ‘RFX’ .............................................. 45 Printer .................................................... 23 Work list................................................ 46
flag ‘S’ ............................................. 45, 80 Pump....................................................... 23

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Coatron A6 Plus

Teco Medical Instruments, Production + Trading GmbH

Copyright Copyright © 2017 by TECO GmbH. Neither the Operator's Manual

Trademarks COATRON is a trademark of TECO GmbH. Other product names

Manufacturer Instrument is produced by

Phone: +49 (0)8773 70780-0

The warranty expires in case of failures caused by

Operator's Manual COATRON A6 PLUS Revised Apr 2017 REV-8 Page 2

1.1 Symbols .......................................................................................................................................................8

1.2 Safety information ..................................................................................................................................9

1.2.1 Intended use ........................................................................................................................................9

1.2.2 Safety information for operation ................................................................................................9

1.2.3 Safety information for MATERIALS ...........................................................................................9

1.2.4 Safety information regarding risk of health ........................................................................ 10

1.2.5 Safety information for cleaning, maintenance and servicing ....................................... 11

1.2.6 Electrical safety ............................................................................................................................... 12

1.2.7 Emc sTATEMENT ........................................................................................................................... 14

2. Installation of the COATRON A6 PLUS .................................................................................................. 15

2.1 Scope of delivery .................................................................................................................................. 15

2.2 Laboratory Requirement .................................................................................................................. 16

2.3 Unpacking the COATRON A6 PLUS............................................................................................... 16

2.4 Switching ON and off .......................................................................................................................... 17

2.5 Installation of Components.............................................................................................................. 19

2.6 Installation of TECAM software ..................................................................................................... 20

2.7 installation Record & Warranty ..................................................................................................... 21

3. Description of the COATRON A6 PLUS .................................................................................................. 22

3.1 Short introduction ............................................................................................................................... 22

3.2 Views of the device.............................................................................................................................. 23

3.2.1 Overview ............................................................................................................................................ 23

3.2.2 Rear view ........................................................................................................................................... 24

3.2.3 REAGENT Positions ....................................................................................................................... 24

3.2.4 Keypad ................................................................................................................................................ 27

3.2.5 Screen segments ............................................................................................................................. 28

3.3 Measurement principle ..................................................................................................................... 28

3.3.1 Mathematical principles .............................................................................................................. 28

3.3.2 Units ..................................................................................................................................................... 29

Operator's Manual COATRON A6 PLUS Revised Apr 2017 REV-8 Page 3

3.3.3 Clotting method............................................................................................................................... 30

3.3.4 Derived fibrinogen ......................................................................................................................... 30

3.3.5 Chromogenic, endpoint and immunoturbidimetric method ........................................ 31

3.4 Test overview ........................................................................................................................................ 32

4. Operation of the COATRON A6 PLUS ..................................................................................................... 33

4.1 Routine measurement with TECAM............................................................................................. 34

4.2 Routine measurement without TECAM ...................................................................................... 37

4.3 Interrupt or exit measurement ...................................................................................................... 39

4.4 Out of liquid or cuvette during measurement ......................................................................... 39

4.5 Continous loading of samples ......................................................................................................... 40

4.6 Measuring the emergency samples .............................................................................................. 41

4.7 Measuring the samples in micro tubes ....................................................................................... 42

4.8 Quality control measurement ......................................................................................................... 43

4.9 Reflex testing ......................................................................................................................................... 44

4.10 Display during measurement ......................................................................................................... 44

4.11 Result warning messages ................................................................................................................. 45

5.1 Submenu New List............................................................................................................................... 46

5.2 Submenu Continue .............................................................................................................................. 51

5.3 Submenu Repeat .................................................................................................................................. 51

5.4 Submenu Stat......................................................................................................................................... 52

5.5 Submenu Overview ............................................................................................................................. 53

5.6 Submenu Print Option ....................................................................................................................... 54