User Manual

CoaDATA 2004

CoaDATA 4004

For in-vitro diagnostic use only!

User Manual CoaDATA 2004/4004

Revision History:

Version Manual Date Analyser Software-

Comment
(Art.-No.) (yyyy/mm/dd) Version - Release -

01.00
2019-03-22 V01.07b, Nov 15, 2018 Initial version
(112-96-090-01)

01.01
2019-07-18 V01.07b, Nov 15, 2018 Update
(112-96-090-02)

Revision History 2
User Manual CoaDATA 2004/4004

Content

1 IMPORTANT INFORMATION 7
Manufacturer and author of this manual 7
Liability Disclaimer 7
Software Copyright 7
Intellectual Property 7
Warranty 8
Exclusions of manufacturer’s warranty 8
Guidelines for getting service assistance 9
2 TERMS, ABBREVIATIONS AND SYMBOLS USED IN THIS MANUAL 10
3 SAFETY 12
Duty of care of the user 12
Intended use 13
Reagents 14
Safety instructions 14
Electrical safety 14
Mechanical safety 15
Reasonable foreseeable and remaining risks 15
Emergency and first aid 16
Fire fighting 16
4 INSTALLATION 17
Name Plate (Serial no.) 17
Component overview 18
2-Channel 18
4-Channel 18
Software 19
Mounting and connecting the analyzer 19
Thermal block and User interface 21
Internal printer 23
Insert or change internal printer paper 23
Deactivate the internal printer 26
CuvCARDs – Load a Cuvette balance 27
ChipCARDs – Store or load methods 31
Connection to a HOST (Port B) 32
Connecting an external Barcode Scanner 33
Connection to an external Printer (Port A) 35
Connecting an electronic Start-Pipette 36

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User Manual CoaDATA 2004/4004

Check the function of electronic Start-Pipette 37

5 ANALYZER AND METHOD PARAMETERS 38
Instrument parameters 38
Method memory positions and Default Method Parameters 38
6 OPERATION 40
Measuring principle 40
Evaluation Methodes 40
Difference 40
Kinetics 41
User qualification 41
Switch on the analyzer 42
STANDBY 44
Method selection 45
Measuring Mode (= “cuv in”) 46
Measuring Mode (= “Pat ID”) 47
Carry out a PT Measurement 49
Carry out an aPTT Measurement 52
Carry out a Fibrinogen measurement g/l 55
Parameter configuration - Access WITHOUT PIN 58
Calibration curve 58
Set calibration curve points for PT 59
Set calibration curve points for Fibrinogen 61
Set MNP value 63
Save parameters 64
Parameter configuration - Access WITH PIN 64
Menu <General> 65
6.7.1.1 Method name 66
6.7.1.2 Load default 67
6.7.1.3 Copy method 69
6.7.1.4 Exchange method 70
6.7.1.5 Read from ChipCARD 71
6.7.1.6 Write to ChipCARD 74
Menu <1st conversion> 76
6.7.2.1 Set <Reference curve> 77
6.7.2.2 Set <Unit> 79
6.7.2.3 Set <Decimal place> 79
6.7.2.4 Set Min/Max value (Conversion limits) 80
6.7.2.5 Set calibration points 80
6.7.2.6 Set <Time Interpolation> 81
6.7.2.7 Set <Value Interpolation> 81

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User Manual CoaDATA 2004/4004

Menu <2nd conversion> 82

6.7.3.1 Select <INR> and set the ISI value 83
6.7.3.2 Select <RATIO> and set MNP 83
6.7.3.3 Set <None> 84
Menu <3rd conversion> 84
Menu <Measurement> 85
6.7.5.1 Set Start Reagent Volume/ Reagent Lot. Number 86
6.7.5.2 Set Incubation time 87
6.7.5.3 Set Start number for Print out 87
6.7.5.4 Set Mixer function 88
6.7.5.5 Set <Learn-/Lag times> 89
rd
6.7.5.6 Set parameters for 3 conversion 89
6.7.5.7 Set Minimum and maximum time 90
6.7.5.8 Set measuring time 91
UTILITIES 92
SubMenu <Printer> 93
SubMenu <Port A> 94
SubMenu <Port B> (virtual com port via USB) 95
SubMenu <Beeper> 98
SubMenu <Language> 99
SubMenu <Date/Time> 100
SubMenu <Reagent-Stirrer> 101
SubMenu <PIN Code> 102
SubMenu <Start-Pipette> 103
SubMenu <Cuvette-Test> 104
SubMenu <Parameter import> 105
SubMenu <Parameter export> 107
SubMenu <Info> 109
SubMenu <Photometer calibration> 110
Sample print-outs PT and calibration 111
7 TROUBLESHOOTING 113
Application errors 113
Cancel incubation / measurement 114
Status messages cuvette balance 114
Error messages with respect to turbity in sample 115
Errors during operation 118
Warnings 119
8 MAINTENANCE AND HYGIENE 121
Safety 121
Operating and auxilliary materials 122

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User Manual CoaDATA 2004/4004

Disinfectant 122
Hand protection 122
Eye protection 122
Other 122
9 TRANSPORT 123
Prepare the analyzer for packaging 123
Pack the analyzer for shipment 124
10 SERVICE INFORMATION SHEET (CUSTOMER COMPLAINT) 129
11 DECOMMISSIONING AND STORAGE 130
12 DISPOSAL OF THE ANALYZER 131
13 APPENDIX 132
Technical data 132
System related 132
Electrical data 133
Environmental requirements 133
Disposables 134
Materials supplied 134
Optional equipment 134
Supplier documentation 134

Content 6
User Manual CoaDATA 2004/4004

1 IMPORTANT INFORMATION

Manufacturer and author of this manual

LABiTec®
LAbor BioMedical Technologies GmbH
An der Strusbek 6
D 22926 Ahrensburg
Tel.: +49-4102 47950
Fax.: +49-4102 479535
Email: [email protected]
Website: www.labitec.de

Liability Disclaimer

LABiTec LAbor BioMedical Technologies GmbH makes no express or implied warranty

regarding this manual, its quality, performance, or appropriate use regarding any type
of specific procedure. Furthermore, this manual may be modified by LABiTec LAbor
BioMedical Technologies GmbH without notice and without implying any obligation or
liability on the part of the company.

Software Copyright

All software by LABiTec LAbor BioMedical Technologies GmbH is the intellectual

property of the LABiTec LAbor BioMedical Technologies GmbH. Intellectual property
rights shall remain with LABiTec LAbor BioMedical Technologies GmbH. You are
entitled to use the software and the printed accompanying material at a place of work
that cannot be transferred. Any violation of property rights or copyright or trademark or
using conditions may be subject to legal action. LABiTec reserves the rights to modify
the software, documentation as well as this operator manual without prior written
notice.

Intellectual Property

LABiTec LAbor BioMedical Technologies GmbH CoaDATA 2004/CoaDATA 4004 is a

trademark of LABiTec LAbor BioMedical Technologies GmbH. All rights reserved.
No part of this publication may be reproduced, transmitted, transcribed, stored in a
retrieval system, or translation into any language (human or computer) in any form, or
by any means whatsoever, without the prior written permission of LABiTec LAbor
BioMedical Technologies GmbH.
Any reference to products, documentation, articles within this publication not expressly
described as property of LABiTec LAbor BioMedical Technologies GmbH shall be
considered as intellectual property of the publishing company of this certain product,
documentation and or article.

1 Important Information 7
User Manual CoaDATA 2004/4004

Warranty

LABiTec LAbor BioMedical Technologies GmbH warrants this product against defects
to the original purchaser in accordance with legal requirements or other mutual
agreements after the date of supply in material and workmanship and defects arising
from failure to conform to specifications applicable on the date of supply, provided they
are properly installed, operated and used with accessories and consumables in
accordance with the operating and service instructions.

Exclusions of manufacturer’s warranty

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

 Improper use/operating faults and non-adherence to the user instructions.
 Attempted repairs by the customer or third-parties without authorization by
manufacturer.
 Faulty maintenance by third parties without authorization by manufacturer.
 Defects caused by power failure, like wrong main voltage, overvoltage, wrong
frequency of main voltage or similar reasons.
 Accidents, storms, lightening, fire, water/other liquids, other natural
catastrophes, theft, riots, plundering, the effects of war or other instances of acts
of god.
 Defects caused by transportation/shipping.
 The use of third party components, unauthorized consumables or accessories
which do not comply to manufacturers specifications.
 Defects caused by non-authorised analyzer and software changes.
 Defects caused by bypass of safety functions, deletion of passwords etc.
 Loss of customer data or software from repair and installation processes.
 Defects caused by improper use of analyzer.
 Defects caused by inappropriate environmental conditions.
 Analyzer were information or analyzer parts have been removed or changed
necessary for a clear identification
 Parts of the analyzer which are subject to natural wear and tear.
 Defects which are the result of breaks and scratches, dirtying on e.g. LCD
displays, membrane keypads or dirtying of the measuring channels.
 Defects which are caused by use of improper printer paper.

1 Important Information 8
User Manual CoaDATA 2004/4004

Guidelines for getting service assistance

NOTE
Supporting our service department with the basic information as
detailed as possible will help us to give you the needed assistance.
Thank you in advance.

Customer identification
 Customer
 Name
 Address
 Country
 Email
 Phone
 Fax
 Distributor / Enduser (in case of enduser, please state the distributor)

Analyzer identification
 Type of analyzer
 Serial-Number (SN)
 Reference number (REF)
 Software version

Problem description

Describe the problem as detailed as possible. This may clarify the situation.
 Display Messages
 Printouts
 Screenshots
 Photos

In case of analytical problems further information will be needed.

Describe the problem as detailed as possible.
 Test type: eg. PT, aPTT, Fibrinogen, ….
 Sample (Patient sample, Control N, Control P, dilution, ….)
 Reagent Manufacturer, Name of reagent, Order number, Lot Number, date of
expire.
 Leaflets
 Actual measured results, raw value in seconds, converted values.
 Conversion, Conversion table, ISI, …

1 Important Information 9
User Manual CoaDATA 2004/4004

2 TERMS, ABBREVIATIONS AND SYMBOLS USED IN THIS MANUAL

Table 2-1 Symbols used in this Manual, on the analyzer itself, and on available
accessories and consumables

Symbol Meaning Symbol Meaning

Manufacturer Date of manufacture

Batch Code Serial Number

Do not use if packaging is

CE Conformity
damaged

Do Not Reuse
Refer to Operators Manual
e.g. cuvettes, mixer stir bar.

Caution
Protect From Sunlight Danger
Warning

Traceblility number according

Temperature Limitation
to customer

Humidity Limitation Important Information

Electric Shock
Biological Risk
Warning

Fuse This side up

Separate collection, handling

and disposal for waste
Keep dry! electrical and electronic
equipment and its
components.

2 Terms, abbreviations and symbols used in this manual 10

User Manual CoaDATA 2004/4004

Symbol Meaning Symbol Meaning

Observe Precautions for

handling electrostatic sensitive
Do not throw devices (ESD) / Warning of
damages by electrostatic
discharge.

In vitro Diagnostica

Table 2-2 Explanations of styles used in this manual

Symbol Meaning

● Instructions that have to be followed

Explanations to the given context

Things, that are required, have to be checked or fullfilled

Chapters

Steps that have to be carried out in the given order

2 Terms, abbreviations and symbols used in this manual 11

User Manual CoaDATA 2004/4004

3 SAFETY

This analyzer conforms with the European Directives for in vitro diagnostica.
The analyzer type described in this manual bears an IVD and CE mark, which confirms
the compliance with essential requirements of the Directive 98/79/EC of the European
Parliament on in vitro diagnostic medical devices.

Table 3-1 Explanation of safety symbols and signal words according ISO 3864-1

Symbol Signal Meaning

Word

DANGER Indicates a direct hazard with high risk, which will have as
consequence death or grievous bodily harm if it isn't
avoided.

WARNING Indicates a possible hazard with medium risk, which will

have as consequence death or (grievous) bodily harm if it
isn't avoided.

CAUTION Indicates a hazardous situation, which if not avoided,

could result in minor or moderate injury.

NOTICE Indicates a Damage Message only device-related.

NOTE Indicates an important note in the manual. Duty of care of

the operator

Duty of care of the user

This User manual describes the analyzer and is directed to all users of the system.
This User manual gives all information necessary for the implementation, maintenance
and packing of the analyzer.
Careful observation of all information, especially of hazards and precautions will ensure
the correct and safe operation of the analyzer. Therefore, it is absolutely necessary to
read the User manual completely.
This User manual was prepared with greatest care. Should you have any questions or
recommendations please refer to your distributor or the manufacturer.

3 Safety 12
User Manual CoaDATA 2004/4004

Intended use

WARNING
For in-vitro diagnostic (IVD) use only!

The CoaDATA 2004/4004 (Model CD12-2-17 and CD12-4-17) named hereafter as

analyzer, are semi-automated 2-channel and 4-channel in-vitro diagnostic analyzer for
coagulation, chromogenic and immunturbodimetric assays of blood plasma.
The analyzer is capable to perform a wide range of coagulometric, chromogenic and
immunologic coagulation tests such as Prothrombin time, activated and partial
Thromboplastin time, Fibrinogen, and special tests like single factor assays, Anti-
Thrombin III, Protein C, Protein S, D-Dimer.
The analyzer is intended for the use by trained operators in coagulation labs for in-vitro
diagnostics.

 Only use the analyzer according to the required ambient conditions.

 Protect the measuring channels from direct sunlight or other light sources.
 Only use pipettes which are being validated in regular intervals.
 Close the light protection cap prior to each measurement.
 Make sure that pipetting does not cause any air bubbles.
 Use a new tip after every pipetting operation to prevent reagent/sample carry-over.
 Only use pipette tips that fit the pipette (e.g. eppendorf pipettes with eppendorf
tips), otherwise secure handling is not guaranteed.
 Always place a cuvette in the measuring channel before pipetting. Ensure each
cuvette is equipped with a mixer.
 Pipetting reagent or sample into the measuring channel can significantly
contaminate the analyzer and could even render it faulty, so that expensive
cleaning or repair might become necessary.
 Only use the original manufacturer’s cuvettes and mixers as they are subject to
strict quality control. The use of 3rd party products and any associated analyzer
problems as a result, will invalidate your guarantee.
 Use cuvettes once only. Multiple use of cuvettes (e.g. cleaned) may produce
incorrect results; this in turn can become an indirect hazard for the patient.
 Perform regular quality control checks. Refer to the guidelines of use provided by
the reagent manufacturer and the local law.
 Before use make sure that the reagents, controls and disposables are not yet past
their expiration date.
 We recommend NOT to set the analyzer to silent mode.

3 Safety 13
User Manual CoaDATA 2004/4004

Reagents
For proper coagulation analysis we recommend to use reagents, controls and buffers
by LABiTec.
Always read the information leaflet in the package and observe the instructions given
by the reagent manufacturer.

NOTE
Utilize reagents and controls only according to directions as provided
by the reagent manufacturer to avoid incorrect measuring results or
malfunction of the analyzer.

Safety instructions

Electrical safety

DANGER - ELECTRIC SAFETY

Never remove protective covers or secured components.

The stated input voltage of the wide-range power supply has to comply
with the local mains voltage.
Never place the analyzer on a moist surface (floor, worktable or
countertop), nor place containers of liquids on top of the analyzer.
Liquids leaked out into the analyzer may cause an electrical shock.
Even after a device has been switched off, components can be still
under voltage as a result of electrical charge and represent a risk of an
electrical shock.

3 Safety 14
User Manual CoaDATA 2004/4004

Mechanical safety

WARNING - MECHANICAL SAFETY

Put the analyzer out of operation and secure it against inadvertent

use if you come to the conclusion that it can no longer be operated
safely.

This is to be assumed in the following cases:

 The analyzer shows visible damage.
 The analyzer does not longer work.
 The analyzer has been stored or transported for a prolonged
period under unfavorable conditions.

Reasonable foreseeable and remaining risks

WARNING – BIOLOGICAL RISK

Use disposable nitrile rubber gloves to avoid any hand contact with
potentially infectious material.
Wear goggles as splashes of reagent, plasma or disinfectant might
enter the eye.

WARNING - LASER LIGHT

Be careful when using the external barcode scanner.
Avoid direct eye contact with the laser beam.
Follow the manufacturer’s instructions.

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User Manual CoaDATA 2004/4004

Emergency and first aid

CAUTION
In case of emergency immediately interrupt the operation of the
analyzer.
Switch off the analyzer at the main switch and pull out the power supply
plug from the socket.

Relevant actions to rescue personnell are given in the operational rules determined by
the company.
Following procedure is recommendatory, not binding.
1. If the risk of injury remains when staying where the accident happenend, bring the
person immediately out of the danger zone.
2. Otherwise take care of the person.
3. Provide first aid.
4. Call for help (colleagues, manager, doctor, ambulance…).
5. Take care of the injured person until further help arrives.

Fire fighting

There are no special measurements necessary for fire fighting.

We recommend to use common CO2 fire extinguisher.
Please consider the instructions defined by your company regarding fire protection and
fire fighting.

3 Safety 16
User Manual CoaDATA 2004/4004

4 INSTALLATION

Name Plate (Serial no.)

The name plate can be found on the bottom of the analyzer.

Information (signs) given on the plate is explained in the following.

Manufacturer according to IVD

Manufacture date
Type: Analyzer name (according to customer)

Traceblility number according to customer

Serial number of analyzer

Refers to the User manual with further information

Separate collection, handling and disposal for waste electrical and

electronic equipment and its components

CE Conformity

In vitro Diagnostica

Input: Information about voltage and current

Fuse characteristic 3.5 AT

4 Installation 17
User Manual CoaDATA 2004/4004

Component overview

2-Channel
 Integrated thermal printer
 Thermal block 37.4°C +/- 0.4°C
 18x cuvette positions
 4 positions for reagent bottles (left incl. stirring position)
 2 measuring channels with light protection caps
 Display 2 lines, 20 characters each
 Membrane keypad with keys (CH1,CH2, 0 - 9, Mode, Enter, ESC, <,>)
 ChipCARD / CuvCARD reading unit
 Secure digital memory card (SD Card)
 Power switch ON I, OFF 0
 1x 6-pin Mini DIN RS232-C
 1x USB interface (Type B)
 Start-Pipette interface

4-Channel
 Integrated thermal printer
 Thermal block 37.4°C +/- 0.4°C
 16x cuvette positions
 4 positions for reagent bottles (left incl. stirring position)
 4 measuring channels with light protection caps
 Display 2 lines, 20 characters each
 Membrane keypad with keys (CH1-CH4, 0 - 9, Mode, Enter, ESC, <,>)
 ChipCARD / CuvCARD reading unit
 Secure digital memory card (SD Card)
 Power switch ON I, OFF 0
 1x 6-pin Mini DIN RS232-C
 1x USB interface (Type B)
 Start-Pipette interface

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User Manual CoaDATA 2004/4004

Software

The analyzer software is stored in a memory chip and activated as soon as the
analyzer is switched on.
The software controls the analyzer via start functions for the analytic program. Visual
communication between the analyzer and the user is accomplished via a liquid crystal
display with two rows and a 20 character string each.
Via the display the user is lead through all measurement steps. The user will confirm
these steps either by key strokes or by pipetting start reagent. Thus, correct handling of
the system is guaranteed.

Mounting and connecting the analyzer

 Upon receipt remove the analyzer from its packaging check the content for
damage and completeness and verify that the accessory kit is complete.
 Immediately inform your distributor in the event that the shipment was damaged or
incomplete. Otherwise it results in a loss of claims.
 Upon unpacking keep all package material (e.g. membrane packaging and card
boards) stored at a dry place. You might need them later on to send back the
analyzer to the manufacturer for repair or maintenance purposes.

Proceed as follows to install the analyzer.

1. Prior to installation of the analyzer read chapter 3, page 12.
2. Compare the input range of the external power supply witht the local mains voltage.
Make sure the external power supply meets the local mains voltage.
3. Place the analyzer in a location that is not exposed to excess humidity, any
explosive gases, magnetic influences and direct light, e.g. sun and other light
sources.
4. Place the analyzer on a stable and level surface with at least 150 mm space for
ventilation at all sides.
5. Make sure to meet the environmental requirements, see chapter 13.1.3, page 133.

NOTICE
The analyzer is delivered with external power supply and power
cable.
The power cable has to comply with the country-specific regulations.
The analyzer has to be connected exclusively with the delivered
external power supply. Make sure to have a protected ground at the
main socket. Otherwise a safe operation can not be guaranteed.
We do not warrant against a defect of the analyzer in case another
external power supply than the delivered has been used.

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User Manual CoaDATA 2004/4004

6. Connect the cable with the 4-pin connector of the external power supply to the
power supply socket of the analyzer.
7. Connect the power cable of the external power to a socket outlet without voltage
surges produced by heavy power users, e.g. lifts and centrifuges
8. Ensure easy accessibility of the power On/Off switch at the analyzer rear side and/or
of the main cable of the external power supply at the wall socket to disconnect the
device in case of an emergency.

Interfaces on the rear side

1 2 3 4 5 6

1 USB Port B
2 Serial interface for Barcode scanner or external printer
3 SD card-Slot
4 Electronic Start-Pipette connector
5 Power supply socket
6 Power On/Off-switch
Figure 4-1 Interface connections

Figure 4-2 External Power supply

Figure 4-3 ChipCARD / CuvCARD reader slot on the right side of the analyzer

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User Manual CoaDATA 2004/4004

Thermal block and User interface

Figure 4-4 Thermal block (upper area) and User interface (lower area) of the
CoaDATA 4004 (4-channels)

The operation area of the analyzer consists of the heated Thermal block with
 Reagent positions
 Cuvette positions
 Measuring channels (2/4)

… and of the User interface with

 Number keys
 Mode / Esc / Enter keys
 Channel keys
 Arrow keys (for navigation)
 Display
The function of the keys is described in the following table.

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User Manual CoaDATA 2004/4004

Table 4-1 Key description of the interface

Arrow-key left, right

Left = 1. select display to the left, 2. delete
Right = 1. select display to the right, 2. set decimal
point
Esc-key
1. Switch from measuring to STANDBY
2. Exit a submenu
3. Quit parameter change
4. Exit a menu or save entered or modified data.
Enter-key
1. Confirm selection
2. Advance printer paper
3. Confirm parameter change
4. Printer line feed
Mode-key
1. Calibration
2. Menu selection, analyzer settings and method
parameterization
Number keys = Enter parameters
0-Key = A print-out of the respective parameters for
the selected method is generated by pressing 0
during measuring.

CH1-key: Addresses measuring channel 1

CH2-key: Addresses measuring channel 2

CH3-key: Addresses measuring channel 3

CH4-key: Addresses measuring channel 4

CH1-4 keys, specific to measuring channel:

1. Start sample incubation timer
2. Sample adjustment
3. Manual test start
4. Manual test stop
Current measurement is cancelled if keys are
+ pressed simultaneously. Display: "break"

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Internal printer

Insert or change internal printer paper

NOTE
Never operate the printer without paper!
Please note, without inserted paper or if the printer function is
deactivated you may not be able to print results and parameters.

We recommend to purchase and use the printer exlusively with the

thermal paper offered by the manufacturer.
Operating the printer with another paper might result in malfunction
of the printer with the following effects:
 No paper transport
 Paper abrasion
 No print out

These effects may have the following reasons:

 The paper is too thick / thin
 The paper is too wide or small.
 No thermal paper is used.
 Paper is inserted upside down.

NOTICE
We do not warrant against a defect of the printer unit if the use of
printer paper other than recommended is the is the cause of the
defect.

NOTE
Mind proper storage conditions for the thermal printer paper:
 Dry environment
 Protect from light
 Protect from heat

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User Manual CoaDATA 2004/4004

To add a new roll of paper, proceed as follows:

Figure 4-5 Cover for Printer paper (example)

1. Switch on the analyzer.

2. Press together the sides of the cover with both fingers to remove the cover.

3. Press to move the paper a bit in forward direction.

4. Take the old / empty paper roll, tear off the paper on the rear side and remove the
paper tube.

CAUTION
Never pull the rest of the paper together with the roll from the front
side out trough the rear side.
This would destroy the printer mechanism of the paper feeding, thus
the whole printer unit.

5. Pull out the rest of the paper to the front side.

6. Take a new paper roll and cut the end of the paper with scissors to get a straight,
clear end/ line.

NOTICE
Do not tear the paper as an unequal end could cause a paper jam in
the printer when inserted.

7. Guide the paper into the paper slot of the printer. Stop as soon as you feel some
resistance.

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User Manual CoaDATA 2004/4004

Figure 4-6 Inserting paper in the printer paper slot

8. As soon as the paper has been captured by the paper guides, it will be fed
automatically.

9. Press to move the paper in forward direction.

NOTE
As soon as the red marking stripe on the paper appears → change
the paper roll!
If the paper has been inserted up side down no print will be possible.

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User Manual CoaDATA 2004/4004

Deactivate the internal printer

The printer is preset to "Auto" by the manufacturer.
In case no thermal printer paper is available or necessary you can deactivate the
printer.
To set the printer to <Off> proceed as described:

1. Press or and select UTILITIES.

2. Press and enter the PIN. The first display position shows <Printer>.

3. Press to enter the printer submenus.

4. Press or and select

5. Press to confirm the selection.

6. Press if you want to adjust more parameters.

7. Press to switch to measuring mode.

 If you have changed the settings following display appears:

8. Press to save parameters or to leave the menu without saving.

 If parameters are unchanged an according message appears and the analyzer
turns to STANDBY automatically.

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User Manual CoaDATA 2004/4004

CuvCARDs – Load a Cuvette balance

The analyzer cannot be operated without a loaded cuvette balance.

This allows loading a cuvette credit balance of original cuvettes by means of a cuvette
card, so-called CuvCARD.
The individually loaded cuvette credit balance enables the analyzer to perform
coagulation measurements in the same quantity of cuvettes as loaded to the analyzer.

NOTE
Upon delivery the analyzer is preloaded with a cuvette balance that
corresponds to the quantity of cuvette as delivered in the accessory
box.

Disposal of the CuvCARD may be done in the domestic waste.

Ensure in your own interest that no balance remains on the
CuvCARD.

 Each unit of original cuvettes, suitable for the analyzer, is also equipped with a
corresponding CuvCARD. This CuvCARD carries the same quantity of cuvettes as
you will find in the box.
 Using the CuvCARD you can select, whether the total cuvette credit balance shall
be loaded to the analyzer. Otherwise, if more analyzers of the same type are
available, you can also load only the required number to the analyzer/s.
 Once the cuvette credit balance is fully used, meaning, if measurements of the
same quantity as the loaded cuvette balance have been performed, the analyzer
automatically requests to re-load (reminder to order new cuvettes if used up).

NOTE
We recommend to load the total credit balance on either one
analyzer or, if more analyzer are in the laboratory, split it and load
the necessary amount.
REASON: If the CuvCARD gets lost or is damaged the remaining
balance is lost.

If you do not want to load the total balance, store the CuvCARD at a
dry and safe place.

1. Set the analyzer to STANDBY level, the following display appears.

 Only in this state the analyzer can recognize CuvCARDs.

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Figure 4-7 Insertion of CuvCARD with chip face down (left picture), with chip face up
(right picture)

2. Insert the CuvCARD face down into the reader slot memory chip in the direction of
insertion. Leave the CuvCARD in the reader.
 The following display appears.

The following display appears:

Display Meaning

Displays the quantity of cuvette balance still

<bookable>
remaining on the CuvCARD
Quantity of cuvettes on the CuvCARD
<debit>
which shall be loaded to analyzer.

3. Press to to enter the desired quantity of cuvettes to be loaded from the

CuvCARD to the analyzer.

The following entries are possible:

 Minimum quantity
= 100 cuvettes (if e.g. 99 is entered, a beep indicates the automatic input of a
balance of 100)
 Maximum quantity
= as displayed at <bookable>
 Entries between 100 and the maximum available quantity may be done in steps of
10 cuvettes, for example 100, 110, 120, …200 etc.

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 The following display shows the remaining balance of cuvettes still available on the
analyzer:

 This menu section only appears as long as the cuvette credit balance on the
analyzer is larger than or equals 100 cuvettes.

4. Press or to select among the following options:

Selection Meaning

Remaining cuvette balance on the analyzer

<keep>
shall be kept, no loading from CuvCARD.
Remaining cuvette balance on the analyzer
<overwrite> shall be overwritten by loading a cuvette
balance from the CuvCARD.

NOTE
When loading a cuvette balance from the CuvCARD to the analyzer,
the remaining balance eventually still on the analyzer will be
overwritten. Make sure the balance on the analyzer is fully used prior
to loading a new balance from the CuvCARD!

5. Press to confirm.

6. Wait until the message appears to remove the CuvCARD.

7. Remove the CuvCARD from the reading unit and the analyzer automatically turns to
the measuring mode “cuv in”.

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 An automatic printout follows if the printer is set to «On».

NOTE
To print a short overview of method relevand data e.g. Lot Number,

remaining cuvette balance, select the desired method, press

to enter the measuring mode and then press . The printout starts
automatically.

When the cuvette balance has been loaded, the analyzer will automatically print the
following information:
========================
CuvCARD balance
loaded to
CoaDATA 4004 Type of analyzer
Vxx.xx Actual software version of the analyzer
SerNo. Axxxxxxx Serial number of analyzer
Date/Time: Date and time of loading process
dd.mm.yyyy, hh:mm:ss
--CuvCARD Info--
Lot Number = xxxxxxxx Lot Number. of loaded cuvette/mixer
Balance = xxx Loaded balance on analyzer
Remaining balance Remaining balance on CuvCARD
on CuvCARD = xxx
========================

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ChipCARDs – Store or load methods

 ChipCARDs are used to load or store method-specific information in or from the

analyzer.
 Storage of the Methods on a ChipCARD is helpful, if the user has changed the
parameters inadvertendly and wants to restore the default parameters.

 Also, the method stored on the ChipCARD can be transferred/ written to another
analyzer.
 Unless a measurement is currently running, a ChipCARD can be inserted into the
reading unit to read a method from the ChipCARD or to safe a method to a
ChipCARD at any time.
 If a ChipCARD has been read-in, no further adjustments need to be carried out on
the analyzer, because the analyzer processes the data automatically.
 The method-specific data on the analyzer will be overwritten by the ChipCARD
data.

 Only one method can be stored at the time on the ChipCARD.

 The operator has the possibility to set customized methods not stored as default by
the manufacturer and write them onto a ChipCARD.
 If you want to order blank ChipCARDs please contact our sales department.
 For further information how to enter the menu, read chapter 6.7.1.5, page 71 and
chapter 6.7.1.6, page 74.
 For troubleshooting see chapter 7, page 113.

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Connection to a HOST (Port B)

For software activation of the HOST connection, see chapter 6.8.3, page 95.
To connect the analyzer to the HOST a special USB cable with USB-A (for HOST) and
USB-B (for analyzer) connection.

Figure 4-8 USB cable with USB-A (for HOST) and USB-B (for analyzer)

Figure 4-9 USB cable connected to the analzyer via USB-B

Figure 4-10 USB cable connected to HOST via USB-A

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Connecting an external Barcode Scanner

1 2

1 USB-B (Port B)
2 Serial interface RS 232 C / external Barcode Scanner / Printer (Port A)
Figure 4-11 Interface for External Barcode scanner, Printer and Host connection

If the analyzer is connected to a HOST via Port B, the software requests to scan a
barcode (= patient-ID) or a manual input of the patient-ID number.
For software activation of the external barcode scanner see chapter 6.8.3, page 95.
The barcode scanner can be connected via the RS 232-C interface (2).
Hardware adaption of the scanner cable might be required.
 The power supply of the analyzer for the external barcode scanner is 5V DC with
max. 500 mA.

 The patient-ID input can either be carried out by entering the number manually
(numerical data) or with a barcode scanner (alpha numerical).
 For functionality of the external barcode scanner the analyzer has to be set to Port
B = HOST to enable the communication.

1. Connect the analyzer to HOST via the USB-B interface(1)

2. Connect the barcode scanner to serial interface (2).

3. Switch on the HOST and wait at least 30 sec.

4. Switch on the analyzer.

5. Select UTILITIES with or .

6. Press and enter the PIN (default = 11111).

7. Press or and select <Port B> and set Port B to HOST.

8. Press .

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9. Press

10. Press to save parameters or to leave the menu without

saving.

 The display shows “Pat ID” to indicate, that a number is requested.

11. Press respective channel key and manually enter the Patient-ID or scan the
barcode.

 Automatically “cuv in” appears to indicate, that the measuring procedure can be
started.

See also chapter 6.5.3 page 47 to start e.g. a PT measurment.

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Connection to an external Printer (Port A)

For software activation of the external Printer, see chapter 6.8.1, page 93.

1 2

1 Serial interface RS 2342 C / external Barcode Scanner / Printer (Port A)

2 Electronic Start-Pipette connector
Figure 4-12 External Printer and Host connection

Serial interface data for external printer

 9600 baud
 8 bit
 no parity
 1 stop bit
 no Handshake

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Connecting an electronic Start-Pipette

Two and four channel analyzer offer the possibility to connect an external electronic
Start-Pipette (see (2) in Figure 4-12).
Normally, automatic detection of added start reagent is guaranteed, thus a Start-
Pipette is not necessary.
However, once the electronic Start-Pipette is connected and activated the coagulation
measurement will be automatically detected by means of an electronic impulse when
adding the start reagent into the cuvette.
To operate the electronic Start-Pipette properly observe the manufacturer’s
instructions.

1. Select UTILITIES with or .

2. Press and enter the PIN (default = 11111).

3. Select the Start-Pipette in the UTILITIES menu.

4. Press to confirm.

5. Press or and select “On” or “Off”.

6. Press to activate the respective selection.

NOTE
Automatic start of measurements via normal pipette is not possible if
the Start-Pipette is activated.
If the user does NOT pipette the start reagent into the light path by
use of the electronic Start-Pipette, the measurement is not started
since the software detects no peak of the photometer measuring
value.
For a safe operation of the electronic Start-Pipette the analyzer
offers a function to check the electronic impulse. Follow the
procedures as described below. (Start-Pipette must be activated
before).

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Check the function of electronic Start-Pipette

NOTE
To ensure proper function of the electronic Start-Pipette, please
make sure the piston is fully pressed down when pipetting into the
cuvettes.

1. Connect the adapter cable of the electronic Start-Pipette to the analyzer.

To activate the electronic Start-Pipette:

1. Set analyzer to STANDBY.

2. Press or until <UTILITIES> appears in the display.

3. Press and enter the PIN Code (factory default: 11111).

4. Press or until the displays shows the following:

5. Press to confirm.

 This menu will be only be available, if a Start-Pipette was activated in the

UTILITIES menu.

6. Press the start button at the pipette fully downwards and keep it pressed. The
following display shows: Pipette-Test - Start button pressed.
7. Release the start button has been released the display changes again to:
Pipette-Test _ _ _ _
 Now, proper operation of the electronic Start-Pipette is assured.
 The electronic Start-Pipette is available for measurements.

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5 ANALYZER AND METHOD PARAMETERS

Parameters are stored in the EEPROM memory. The parameters of the analyzer are
preset by the manufacturer.

NOTE
Before routine tests can be performed, the user must change certain
reagent-specific parameters such as Lot Number and calibration
curve.
Otherwise results have no correct relation to the actual reagent.

Instrument parameters

The following default parameters are preset:

Program version: V x.xx Release mm.dd.yy
Printer AUTO
Port A OFF
Port B OFF
Beeper ON
Stirrer ON
Startpipette OFF
Language English
Reagent-Stirrer ON (250 rpm)
PIN Code 11111

Method memory positions and Default Method Parameters

The analyzers provide up to 15 method memory positions, whereas some are already
preset with method parameters (factory defaults). The following overview in
Table 5-1 Default method parameter (for 2-channel and 4-channel plasma), no
parameters are deposited in Memory positions 11-15
on the next page, shows the preset method parameter and memory positions.
Before you start with your analysis the method parameters must be updated for the
respective reagent as described in chapter 6.6, page 58 and chapter 6.7, page 64.

<empty>

The method memory positions <empty> are free positions where new methods can be
entered manually or installed and modified by copying existing methods or using a
ChipCARD, see chapter 6.6, page 58 and 6.7.1.5.

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6 OPERATION

Measuring principle

The analyzer combines two measuring modes, the photometric and the
turbodensitometric measuring principle. The photometric and the turbodensitometric
measuring principle use an LED as a light source and a photodiode as a light receiver.
In-between the LED and the photo receiver, a cuvette is located containing the reagent
plasma medium. The light intensity is converted into a digital value (photometry = milli-
absorbance, turbodensitometry = digits). Depending on the selected test application,
the system automatically selects the defined measuring mode.
In the photometric measuring principle, the LED is set to a fixed current value. After
adding the reaction trigger, the entire test batch is stirred for a defined period of time.
The light energy measured at the receiver is cyclically converted into the photometric
measuring unit absorbance and displayed as a reaction curve. The determined raw
values are finally converted into the respective units, e.g. %, Ratio, INR, mg/dl, g/l.
In the turbodensitometric measuring principle, after adding the reaction trigger, the LED
is adjusted to a desired intensity and fixed to this current value for the entire measuring
duration. During the entire measuring time, the reagent plasma medium is stirred
permanently by means of a mixer in the cuvette. During the measuring process, the
mixer ensures homogeneity of the reagent plasma medium. At the same time, the
movement of the mixer creates a small vortex, which ensures that even the smallest
fibrin clot forms in front of the photo receiver. The determined raw values are finally
converted into the respective units, e.g. %, Ratio, INR, mg/dl, g/l.

Evaluation Methodes

Difference
The evaluation Difference also assumes curve shape which initially provides constant
absorbance values. After a certain time (T1) the absorbance changes into an S-shaped
curve until consistent absorbance values (T2) will be measured again on a different
level. In this evaluation the difference between the two consistent absorbance values is
determined.

Figure 6-1 Difference

Evaluation
Analogous to the Fixed Extinction evaluation the baseline which corresponds to the
beginning extinction of the measuring curve is determined via regression. Based on the
maximum measuring time T2 (final extinction) minus Postphase T1 (beginning
extinction) the raw value in mExt. is calculated. A calibration curve proportionally
converts the raw value into units such as IU, mg/dl, g/l, %.

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Kinetics
The Kinetic evaluation assumes a consistently increasing or decreasing curve shape.
For this evaluation the slope of the curve is calculated in mExt./min.

Figure 6-2 Kinetics

Linearity Control
For Kinetic curves at first it is checked whether the curve is linear. Once evaluated the
mean, standard deviation and the coefficient of variation of the partial slopes are
calculated.
Evaluation
If the curve is linear the mean value of the change of mExt./min is calculated. This
value is provided as slope for the measuring curve. A calibration curve proportionally
converts the raw value (mExt./min.) into units such as IU, mg/dl, g/l, %.

User qualification

WARNING
It is absolutely necessary that only skilled personnel will access the
parameter menu with a PIN Code as improper handling of the
analyzer might cause inaccurate measuring results. (see chapter
6.8.8, page 102 <PIN Code>).
All settings in the parameter menu must be done in accordance with
manufacturer requirements.
Upon alteration a parameter protocol must be printed in order to
check all settings again.

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Switch on the analyzer

NOTE
Communication with the analyzer is performed via the liquid crystal
display. We assume that you are familiar with the function of the
individual keys as described in chapter 4.5, page 21.
Contact your local distributor with regard to adjustment of display
contrast if the display cannot be correctly read.

 Switch on the analyzer with the power ON/OFF-switch to position I (see Figure
4-1.).
 Switch off the analyzer with the power ON/OFF-switch to position 0.

Following information appears on a “floating display”:

 Analyzer name
 Program version and date
 Name of distributing company

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Warm-up time

NOTE
The analyzer requires approximately 30 minutes to warm-up the
thermal block to an operating temperature of 37.4°C.
During the warm-up no measurements are possible.
Only switching between menus is possible and settings can be
adjusted.

 The display shows the actual temperature of the thermal incubation block.

 If the target temperature is reached, another 15 minutes serve as temperature

stabilizing time.

 A timer counts down to 00:00 min. and displays the remaining time until the
analyzer is ready for measurements, respectively.

 Use the warm-up phase to load the analyzer with cuvettes and reagents for
testing. Ensure each cuvette is equipped with a mixer.

 Comply with the instructions of the reagent manufacturer.

 Compare the method parameters with those stored in the analyzer.
 For your own safety follow instructions for hygiene.

As soon as the operating temperature has been reached, the following display
appears.

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1. Remove all cuvettes from the measuring channels and close the light protection
caps.

NOTE
Make sure all cuvettes are removed from the analyzer’s measuring
channels prior confirm the message; otherwise the automated
cuvette detection and photometer calibration may not work properly.

2. Press any key to confirm the message.

 A photometer calibration is automatically carried out for all channels.

 After the photometer check, the analyzer turns to the measuring mode
automatically and is ready to operate.

STANDBY

When the analyzer has reached the required temperature the display turns
automatically to STANDBY.
The temperature of the thermal block as well as the last method used will be displayed.
PT Method is shown by default. However, always the last method set by the user will
be displayed when switching on the analyzer.

 Press

 Remove all cuvettes from the measuring channel and close the light protection
cap.

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NOTE
Make sure all cuvettes are removed from the analyzer’s measuring
channels prior confirm the message; otherwise the automated
cuvette detection may not work properly.
A message appears that the bright value failed.

Remove the cuvette and press

 Press any key to confirm to proceed.

 A photometer calibration is carried out automatically.

 After the photometer check, the analyzer turns to the measuring mode
automatically and is ready to operate.

Method selection
STANDBY is the level from where the user can switch between and select the
necessary method or carry out settings in UTILITES menu.

 Press or to select a method or UTILITIES.

 After the required selection press and enter the PIN (11111) to access
the according menu.

You can also:

 Press up to to quick select a test (method). Each test is assigned to an

according number (1 = PT; 2 = aPTT; 3 = Fibrinogen etc.).

 Press to quick select UTILITIES.

To start the measuring see next chapter.

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Measuring Mode (= “cuv in”)

NOTE
Make sure all cuvettes are removed from the analyzer’s measuring
channels prior confirm the message and settings are correct.

1. Press to switch to the measuring mode of the according method.

 The selected method has been initialized.

 Only in this mode measurements can be carried out.
 “cuv in” requests the user to place the cuvettes into the measuring channels.

Depending on the model two or four measuring channels described as CH1, CH2 and
CH3*, CH 4* (* = only at 4-channel) are available for measuring.

NOTE
For all tests you can do single determination measurements, with
one result. A mean value calculation from two single values
afterward is not supported by the software.
The measuring channels can only process one selected method e.g.
PT at the time, that means once a method is selected it will be
processed in all channels. It is not possible to select a method for
one measuring channel and a different for another.

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Measuring Mode (= “Pat ID”)

If HOST is activated in the UTILITIES menu (chapter 6.8.3, page 95) the measuring is
carried out the following.

1. From STANDBY press to enter the measuring mode (Pat ID).

2. Press on the CH1 (CHx = channel key).

3. Enter the patient ID manually, e.g.12569 (with number keys) or with barcode
scanner.

4. Press within <30 sec.

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NOTE
If you wait over 30 sec without entering the ID or with entering the ID
but without pressing Enter to proceed, the following message
appears:

Then, the display automatically switches back to Patient ID display.

 From this point (= “cuv in”) the measurement can be started as described in the
next chapter).

When the measurement is finished (= results appear on the display) all information is
also transferred to the HOST via USB-Port.
 See also chapter 4.9.1 Connecting an external Barcode Scanner, page 33.

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Carry out a PT Measurement

NOTE
For the special preparation of Plasma and Reagents (reconstitution,
prewarming) please see the according Plasma/Reagent leaflet.
Place the PT start reagent vial and a sufficient number of cuvettes in
the thermal block at the same time as starting the analyzer (or at
least 30 min before starting with the measurement). The temperature
has to be constantly kept at 37,4°C in the reagent and cuvette
positions.

Sample incubation

Sample incubation has to be carried out always in the measuring channels as the
automatically started test-specific incubation time is necessary to get plausible and
reproducible results.

1. Set the analyzer to STANDBY and select the PT method.

2. From STANDBY press to switch to the measuring mode.

3. Pipette 50 µl plasma without air bubbles into a cuvette that has been prewarmed in
the thermal block to 37,4°C.
4. Open the light protection cap of the measuring channel and place the cuvette into
the measuring channel.
5. Close the light protection cap of the measuring channel.
 The analyzer automatically recognizes the cuvette and starts the timer for sample
incubation (timer count down).

 A 5 second period of intermitting beeps indicates, that the measurement can be

startet soon.
 The display shows INCUBATION READY (incubat. ready).

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 After the sample incubation, the measuring channel will be adjusted (zero
adjustment) for the measurement (adj = adjust).

Add start reagent

 After the adjustment the following display appears for the PT-Measurement and
requests to add 100 µl start reagent:

6. Aspirate 100 µl pre-warmed start reagent and pipette it vertically through the hole of
the light protection cap of the measuring channel into the cuvette.
 The measurement starts automatically.
7. Continue in the same way for the other channels.
 During the measurement the display shows the measuring time until the clot is
formed.

 If the beeper is activated an acoustic signal indicates the recognition of clotting in

the cuvette and stops the timer.

 The maximum measuring time is set for every method individually in the parameter
settings, thus if no clotting is detected an acoustic signal indicates that the maximal
measuring time is reached without clotting detection.
 If conversions are programmed the measured values will be converted
automatically.
 The results (time in sec; %; INR) are displayed consecutively for a duration of 5
sec. on each channel.

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Results

Results, here on CH1 for PT, are displayed intermittently as time in sec, conversion to
% and INR.

 If the printer is set to <Auto> the result is printed automatically.

 If the printer is set to <On> press the respective CHx key to print the result.
PT
Patient _ _ _ _ _
dd.mm.yyyy,
hh:mm:ss
No. = 2
Channel = 1
Time = 12.1 s
% = 92.4
Ratio = 1.04
Figure 6-3 Example print out of PT result

 After the print out, “cuv out” appears in the display.

 Open the light protection cap, take out the cuvette, close the lid and press CH1.
 The display shows “cuv in” again and is ready for the next measurement.

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Carry out an aPTT Measurement

NOTE
For the special preparation of Plasma and Reagents (reconstitution,
prewarming) we refer to the according Plasma/Reagent leaflet.
Place the reagent vial (CaCl2) in the thermal block at the same time
as starting the analyzer (or at least 30 min before starting with the
measurement). The temperature has to be constantly kept at 37,4°C.

Sample incubation

Sample incubation has to be carried out always in the measuring channels as the
automatically started test-specific incubation time is necessary to get plausible and
reproducible results!
1. Set the analyzer to STANDBY and select the aPTT method.

2. Press to switch to measuring mode.

3. Pipette 50 µl of plasma sample without air bubbles into a cuvette that has been
prewarmed in the thermal block to 37,4°C.
4. Add 50 µl aPTT reagent without air bubbles into the same cuvette onto the plasma.
5. Open the light protection cap of the measuring channel and place the sample
cuvette into the measuring channel.
6. Close the light protection cap of the measuring channel.
 The analyzer automatically recognizes the cuvette and starts the timer for sample
incubation (120 sec. timer count down).

 A 5 seconds period of intermitting beeps indicates the remaining incubation time

and the display shows “incu rdy”.

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 After sample incubation the measuring channels will be adjusted (zero adjustment)
for the measurement (adj = adjust).

Add start reagent

After the adjustment the following display appears:

7. Pipette 50 µl prewarmed start reagent (CaCl2) vertically through the hole of the light
protection cap of the measuring channel into the sample cuvette.
 The measurement starts automatically.

8. Continue the same way for the other channels.

 During measurement the display shows the measuring time until the clot is formed.

 If the beeper is activated an acoustic signal indicates the recognition of clotting in

the cuvette and stops the timer.
 The maximum measuring time is set for every method individually in the parameter
settings, thus if no clotting is detected the acoustic signal indicated that the
measuring time is reached without clotting detection.
 If conversions are programmed the measured values will be converted
automatically.

Results

 The results (time in sec; Ratio) are displayed consecutively for a duration of 5 sec.
on each channel.

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E.g. result in as time in sec:

 If the printer is set to <Auto> the result is printed automatically

 If the printer is set to <On> press the respective CHx key to print the result.
aPTT
Patient _ _ _ _ _
dd.mm.yyyy,
hh:mm:ss
No. = 1
Channel = 1
Time = 33.1 s
Ratio = 1.18
Figure 6-4 Example print out of aPTT result

 After the print out, “cuv out” appears in the display.

 Open the light protection cap, take out the cuvette, close the lid and press CH1.

 The display shows “cuv in” again and is ready for the next measurement.

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Carry out a Fibrinogen measurement g/l

NOTE
For the special preparation of Plasma and Reagents (reconstitution,
prewarming) we refer to the according Plasma/Reagent leaflet.

Sample incubation

Sample incubation has to be carried out always in the measuring channels as the
automatically started test-specific incubation time is necessary to get plausible and
reproducible results.
1. Set the analyzer to STANDBY and select the Fibrinogen method.

2. Then press to switch to measuring mode.

3. Pipette 100 µl of a pre-diluted 1:10-plasma sample without air bubbles in a cuvette

that has been prewarmed in the thermal block to 37,4°C.
4. Open the light protection cap of the measuring channel.
5. Immediately insert the cuvette into the measuring channel.
6. Close the light protection cap of the measuring channel.
 The analyzer automatically recognizes the cuvette and starts the timer for sample
incubation (60 sec. timer count down).

 A 5 seconds period of intermitting beeps indicates the remaining incubation time

and the display shows “incu rdy” for Incubation ready.

 After sample incubation the measuring channel will be adjusted (zero adjustment)
for the measurement (adj = adjust).
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Add start reagent

After the adjustment the following display appears:

7. Aspirate and pipette 50 µl start reagent vertically through the hole of the light
protection cap of the measuring channel into the sample cuvette.
 The measurement starts automatically.

8. Continue in the same way for the other channels.

 During measurement the display shows the measuring time.

 If the beeper is activated an acoustic signal indicates the recognition of clotting in

the cuvette and stops the timer.
 The maximum measuring time is set for every method individually in the parameter
settings, thus if no clotting is detected the acoustic signal indicates that the
maximum measuring time is reached without clotting detection.
 If conversions are programmed the measured values will be converted
automatically.

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Results

 The results (time; g/l) are displayed consecutively for a duration of 5 sec. on each
channel.
 If the printer is set to <Auto> the result is printed automatically.
 If the printer is set to <On> press the respective CHx key to print the result.

Fib. g/l
Patient _ _ _ _
dd.mm.yyyy,
hh:mm:ss
No. = 3
Channel = 1
Time = 6.3 s
g/l = 2.48
Figure 6-5 Example print out of Fibrinogen result

 After the print out, “cuv out” appears in the display.

 Open the light protection cap, take out the cuvette, close the lid and press CH1.
 The display shows “cuv in” again and is ready for the next measuremen.

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Parameter configuration - Access WITHOUT PIN

The following parameters can be accessed from the measuring mode (cuv in) directly
without entering the PIN Code:
 1st conversion with calibration points
 ISI
 Start Reagent Lot Number
 MNP value (depending on method)
 2nd conversion
 3rd conversion, calibration values (depending on method)
This can be regarded as a Quick Guide for adjustments of the calibration points
according to the selected method and the Start Reagent Lot.No.

Calibration curve
Although method parameters of the analyzer do include preset values for the
calibration curve (of PT and Fibrinogen; %, g/l, mg/dl and time in sec) it is necessary to
adjust the parameters any time you change the Lot Number of the reagents.
The reason is, that the reagent has lot-specific properties, which could lead to wrong
results when the settings do not match the reagents results.
Calibration curves are carried out with special calibration plasma and the new reagent.

NOTE
To set calibration curves /points all relevant methods have to
be set to “ON” under column “Reference curve” in Table 5-1,
page 38.

 A dilution series is prepared to later on set the respective measured values as

calibration points in the analyzer.
 We recommend to carry out a double measurement for each dilution and calculate
the mean.
 Each mean is entered in the analyzer as calibration point as described in the
following chapters.

NOTE
Points on the reference curve that are not to be used must have the
entries 0.0% or 0.0 s.
A minimum of 2 points must be defined. A maximum of 9 points can
be entered.
We recommend to define 4 points (100%, 50%, 25%, 12.5%).

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Set calibration curve points for PT

1. Select the required Method in STANDBY, here PT.

2. Press to set the analyzer to measuring mode.

3. Press from "cuv in" directly without entering the PIN Code.

 The analyzer switches directly to the first calibration point. (Point of highest activity
and lowest coagulation time, previously determined by the calibration curve
measurement).

4. Use number keys to enter the activity of e.g. 100.0% and to set the decimal
point.

5. Press to confirm and enter the next line.

6. Use number keys to enter the clotting time and to set the decimal point for the
respective activity.

7. Press to confirm and set values of the second calibration points.

8. Continue the same way to set subsequent calibration points.

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9. Press to confirm and switch to the ISI.

10. Use number keys to enter the ISI-value and to set the decimal point of the
respective reagent as indicated in the according reagent leaflet in the table of
values.

11. Press to confirm the entry.

12. Press to confirm and set the Lot Number with number keys and to
set the decimal point of the according Start reagent.

13. Press .

14. Press to save parameters or to leave the menu without saving.

 The analyzer switches automatically back to the measuring mode.

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Set calibration curve points for Fibrinogen

1. Select required Method in STANDBY, here Fibrinogen g/l.

2. Press to set the analyzer to measuring mode.

3. Press from " cuv in" directly without entering the PIN Code.
 The analyzer switches directly to the first calibration point. (the point with the
highest concentration, thus the lowest time).

4. Use number keys to enter the activity of e.g. g/l and to set the decimal point.

5. Press to confirm and enter the next line.

6. Use number keys to enter the clotting time and to set the decimal point for the
respective activity.

7. Press to confirm and set values of the second calibration points.

 Continue the same way to set subsequent calibration points.

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8. Press to confirm and switch to set Lot.No. of the according Start reagent

leaflet (use number keys, to switch to the next entry position, or to

enter characters or decimals).

9. Press .

10. Press to save parameters or to leave the menu without saving.

 The analyzer switches automatically back to the measuring mode.

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Set MNP value

NOTE
MNP = Mean of Normal Plasma

1. Select required method in STANDBY.

2. Press to set the analyzer to measuring mode.

3. Press from " cuv in" directly without entering the PIN Code.

4. Press and set the MNP value with number keys.

5. Press to confirm and set the Lot.No. of the according Start reagent.

6. Use number keys to set the Lot.No., press or to enter characters or

decimals and press to switch to the next entry position and continue until
the following message appears:

7. Press to save parameters or to leave the menu without saving.

 The analyzer switches automatically back to the measuring mode (cuv in).

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Save parameters
Generally, after finishing parameterization or when leaving the method menus the
analyzer checks the parameters and the following sequence appears:

If no parameters were changed:

If parameters were changed:

 Press to save parameters or to leave the menu without saving.

Parameter configuration - Access WITH PIN

Detailed adjustments can only be accessed and set with a PIN code, respectively.
 Method Parameter <General>
 Method Parameter <1st conversion>
 Method Parameter <2nd conversion>
 Method Parameter <3rd conversion>
 Method Parameter <Measurement>

Adjustment of the settings are similar among the menus (PT, aPTT, Fibrinogen, etc.).

1. Set the analyzer to STANDBY.

2. Press or to select the required method (here PT is shown).

3. Press to enter respective method.

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4. Enter the PIN Code (Default no. 11111) to access the method parameter menu. See
also chapter 6.8.8 SubMenu <PIN Code>, page 102.

 If the wrong number was entered STANDBY will be displayed again. As soon as
the correct number has been entered, the following display appears:

5. Press or to switch between the menus.

6. Press to enter the respective menu and its sub menus.

Menu <General>

 Press to access the Menu <General>.

The following submenus are available:

Selection Meaning

<Method name> Enter or change a method name

<Load default> Load a default method from memory
<Copy method> Copy a method.
<Exchange method> Exchange method memory positions
<Read from Read a method from a ChipCARD to the analyzer
ChipCARD>
<Write to ChipCARD> Safe a method to a ChipCARD

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6.7.1.1 Method name

The method name, as displayed in STANDBY, can be edited with the character

generator (with arrow keys or ).

The character generator comprises the following characters:
! " § $ % & /= ? + * # < > , . : _
ABCDEFGHIJKLMNOPQRSTUVWXYZ
a b c d e f g h i j k l m n o p q r s t u v w x y z.
To enter or modify a method name follow the description as shown below.

1. Select a method, press and enter the PIN with the number keys to access
the menu. The first display “Method-Parameter <General> appears.

2. Press to confirm.

3. Press or to select <Method name>.

4. Press to confirm selection.

The next display appears.

 The cursor blinks on the first character position.

5. Press or to set the desired character.

6. Press to confirm the character position and to move to the next position.
7. Repeat this process to enter more characters.

8. Once the last character is entered press until the final position is reached.

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9. Press to finally confirm your entry.

NOTE
If you keep the arrow-key pressed the characters will be displayed
faster and you can speed up your selection.
If you keep the Enter-key pressed the cursor will move faster.

Delete character

 Set the cursor with behind the character you want to delete.

 Press to delete the character to the left. Every stroke means one deletion.

6.7.1.2 Load default

Some method memory positions of the analyzer have been preset by the manufacturer.
In Table 5-1, page 38, you will find an overview of the default methods. These
parameters are saved in the preset ROM of the analyzer and can be reloaded.
Either to restore adjusted parameters of e.g. <1 PT> or to load a default method to an
empty memory position e.g. <14 Empty> follow the instructions below.
This is an example to restore original PT settings to memory position <1 PT>.
1. Select < 1 PT> in STANDBY.

2. Press and enter the PIN Code to access the parameter menu.

3. Menu <General> appears, press to enter the menu.

4. Press or and select <Load default>.

5. Press to confirm.

6. Press or to select the desired method, here <1 PT>.

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The following display appears:

7. Press to confirm.

Automatically the next display will be displayed.

8. Press to overwrite the actual method or to not overwrite.

 Automatically the next submenu appears.
 Either you enter more settings or return to STANDBY.

To return to STANDBY proceed with the following:

9. Press several times until the following display appear:

 If parameters have been changed, the following display appears:

10. Press to save the changes or press to leave the menu without
saving.

 The analyzer automatically switches to STANDBY and the user can proceed with
the operation.

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6.7.1.3 Copy method

If you want to load a method which is rather similar to an existing method you can copy
it to the desired method memory position and modify the parameters where necessary.
Follow the instructions below to copy an existing method to another memory position.
For example, method <1 PT> shall be loaded to an empty memory position.
1. When in STANDBY select the method memory position e.g. <11 empty>.

2. Press and enter the PIN Code to access the parameter menu.

3. Select the menu <General> and press or to select the submenu <Copy
method>.

4. Press to confirm the selection. The following display appears:

5. Press to select the desired method <1 PT>.

6. Press to confirm the selection. The following display appears:

7. Press to overwrite the desired method or to leave the menu without

saving.
 Automatically the next submenu appears.
 Either you enter more settings or return to STANDBY.

To return to STANDBY proceed with the following:

11. Press several times until the following display appears:

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 If parameters have been changed, the following display appears:

12. Press to save the changes or press to leave the menu without
saving.

 The analyzer automatically switches to STANDBY and the user can proceed with
the operation.

6.7.1.4 Exchange method

Sometimes it might be useful to exchange method memory positions. Follow the

instructions below to exchange two method memory positions. For example, the
method on position <11 empty> shall be exchanged with method <1 PT>.
1. When in STANDBY select the method memory position <11 empty>.

2. Press and enter the PIN Code to access the parameter menu.

3. In the Menu <General> press or to select the submenu <Exchange

method>.

4. Press to confirm the selection. The following display appears:

5. Press or to select the desired method e.g. <1 PT>.

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6. Press to exchange or press to keep the settings.

 When exchanging, all parameters will be exchanged.

To return to STANDBY proceed with the following:

13. Press several times until the following display appears:

 If parameters have been changed, the following display appears:

14. Press to save the changes or press to leave the menu without
saving.

The analyzer automatically switches to STANDBY and the user can proceed with the
operation.

6.7.1.5 Read from ChipCARD

Background information for the ChipCARD in general is given in chapter 4.8

ChipCARDs – Store or load methods, page 31.
To load method-specific data from a ChipCARD to the analyzer follow the next steps
described.

1. When in STANDBY press or to select the memory position you would like
to overwrite with the ChipCARD data, for example <11 empty>.

2. Press and enter the PIN Code to access the selected memory position.

3. Press or , select <General> , press .

4. Press or , select <Read from ChipCARD> with .

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5. Insert the method-specific ChipCARD into the reader slot.

 The reader slot is located on the right side of the analyzer.
 A message “Insert ChipCARD, then retry!” is shown as floating text on the first line.

 If the ChipCARD is not correct a message “INVALID ChipCARD” as floating text

appears.
6. Remove the incorrect ChipCARD and insert a correct one.
7. Leave the ChipCARD in the reader.

8. Press to confirm.

9. Press or to select among the following options:

10. Select <Yes> to start the loading process.

11. Press to confirm

The following display appears:

 With “Reading parameters from ChipCARD “ the selected method on the analyzer
will be replaced by the new parameters coming from the ChipCARD.

The following display with new method name and corresponding Lot.-No. appears
(exemplary).

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12. Remove the ChipCARD from the ChipCARD reader.

NOTE
Before starting measurements with the new method we recommend
to set the new method name and enter the correct Lot.-No. of the
reagent.

The next submenu <Write to ChipCARD> will be displayed automatically.

To return to STANDBY:

13. Press until the message "checking parameters please wait" appears.
14. If there was no change in the parameters the analyzer switches automatically to
STANDBY.
15. If parameters have been changed the following message appears:

16. Press to save parameters or to leave the menu without saving.

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6.7.1.6 Write to ChipCARD

Apart from the possibility to load method-specific data from a ChipCARD, such data
may also be saved from the analyzer onto a ChipCARD for later use.
The steps are the same between all methods.
Remember however, that only one method can be saved on one ChipCARD at a time.
A CuvCARD also a used CuvCARD – that means – a CuvCARD with no credit left
cannot be used as a ChipCard to store method parameters.
Measurement results and measurement curves cannot be saved.
To save method-specific data on a ChipCARD follow the steps as decribed.

1. When in STANDBY, select the method memory position you would like to save on
the ChipCARD, for example <1 PT>.

2. Press and enter the PIN to access the selected memory position.

3. Enter the menu <General> with and select the function <Write to
ChipCARD>

Insert the ChipCARD into the reader slot with the memory chip facing up. Leave the
ChipCARD in the reader, see chapter 4.7, page 27, Figure 4-7 for correct insertion and
chapter 4.8 ChipCARDs – Store or load methods, page 31 for more information.

4. Press to confirm the selection.

5. Press or to select among the following options:

6. Select <Yes> and and press to confirm.

The following display appears:

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then

 With “Writing parameters to ChipCARD “ the parameters on the ChipCARD will be

replaced by the new parameters coming from the analyzer.
7. Remove the ChipCARD from the ChipCARD reader.

Automatically, the next menu appears:

8. Press until “checking parameters please wait" appears, then:

9. Press to save parameters or to leave the menu without saving the

changes.

10. Automatically STANDBY or the measuring mode is reached.

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Menu <1st conversion>

NOTE
Evaluating the measurement results with the set 1st conversion
parameters means that the results are calculated based on
previously determined calibration points or calibration values given in
the lot-specific PT reagent leaflet.

You have two options to change the <1st conversion> settings.

1. WITHOUT a PIN Code as described in chapter 6.6, Parameter configuration -
Access WITHOUT PIN, page 58.
2. WITH a PIN Code as described in the following.

 Method parameters are preset by the manufacturer. Before you start with the
analysis, certain parameters (Lot.-No., calibration points) must be updated for the
respective reagent.

Table 6-1 Overview 1st conversion parameters

Selection Meaning

<Reference curve> <rising/falling>

Rising or falling reference curve
<Unit> Unit in % of reference curve to be entered by the
text generator
<Decimal place> No. of digits after decimal point (format xxx.x)
<Min./Max. value> Ranges of activity/concentration
<Points> Entering a 9-point reference curve
<Time interpol.> Linear / Reciprocal / Logarithmic
<Value interpolation> Linear / Reciprocal / Logarithmic
<None> No conversion

1. Set the analyzer to STANDBY <1 PT>.

2. Press enter the PIN Code (factory default: 11111).

 See also chapter 6.8.8 SubMenu <PIN Code>, page 102.

 If the number was incorrect STANDBY display appears again.

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 If the correct PIN Code was entered, the following display appears:

3. Press or to switch to 1st conversion.

4. Press

5. Press to enter reference curve options.

<None>

 Press or and set 1st conversion to <None>.

 Then press to confirm.

 If <None> is selected instead of <Reference curve> under <1st conversion> no

conversion will be calculated.

6.7.2.1 Set <Reference curve>

1. Press the following display appears:

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2. Press or to choose between falling and rising.

Reference curve = falling

8
Fibrinogen [g/l]

0
0 10 20 30
Time [sec]

Reference curve = rising

300
Antithrombin [ng/ml]

200

100

0
0 1000 2000 3000

mE

Figure 6-6 Examples for falling and rising Reference curves

3. Press to confirm the selection

NOTE
Reference curves must be entered as follows.
For rising curves (inhibitors, D-Dimer 405/750nm) start with the
lowest mE-value the lowest converted value (see also Figure 6-5).
For falling curves (coagulation factors) start with the shortest
measuring times (sec) and the highest converted value (%, g/l,
mg/dl).
The software will support this procedure only!

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6.7.2.2 Set <Unit>

 Character format, e.g. mg/dl.

 max.: 4 digits.
 The fraction bar is fix.

 Select the characters for the unit and press to confirm.

6.7.2.3 Set <Decimal place>

NOTE
Regardless of the language used a dot is always used as decimal
instead e.g. a comma.

The display to enter the digits (decimal place) appears.

There are 4 alternatives:

1. <Format xxxx.>
2. <Format xxx.x>
3. <Format xx.xx> or
4. <Format x.xxx>

 Press or to select the required format and press to confirm.

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6.7.2.4 Set Min/Max value (Conversion limits)

Here, you can enter the minimum and maximum values for the calibration curve and
conversion.

 Set minimum and maximum value with number keys and to set the decimal

point and press to confirm.

 An error message (Min Value reached – no more points) appears if the values are
outside the ranges or only the time but no converted result will be displayed.

6.7.2.5 Set calibration points

In the following sequence a 9-point reference curve can be entered.

 A minimum of 2 points must be defined. We recommend defining at least 4 points.
 Points in the reference curve that are not used need entries of 0.0 % and 0.0 s. As
soon as e.g. the 5th point has the entry 0.0 the next point (here the 6th) will not
appear.
 Before you save the adjustments and return to the measuring mode, check all
calibration points for proper entries.

 Press to enter the first reference curve point.

 For a “PT” the point of highest activity and lowest coagulation time in the calibration
is for example the following:

1. Press to confirm the activity of 100.0%, or

2. Press number keys to overwrite the actual values and to set the decimal point.

3. Press to confirm the entry. The cursor changes to a time setting.

4. Enter the clotting time for the respective activity of 100.0%.

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5. Press to confirm the entry, the field for the next point on the reference curve
appears automatically.

6. Verify or adjust the second calibration point as previously described.

7. Proceed as described above to set the remaining calibration points.

6.7.2.6 Set <Time Interpolation>

As soon as the last point on the reference curve has been confirmed the following
display appears:

For the interpolation of the time axis the following options can be selected:
<linear>, <reciprocal>, <logarithmic>.

 Press or to select e.g. <linear> and press to confirm.

6.7.2.7 Set <Value Interpolation>

In the following display you can select interpolation modes for the
activity/concentration: <linear>, <reciprocal>, <logarithmic>.

 Press or to select e.g. <reciprocal> and press to confirm.

The following display appears:

 Press to access measuring or to set or verify more parameters.

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Menu <2nd conversion>

NOTE
Results are calculated based on set MNP (= Mean Normal Plasma).
ISI values are given in the leaflet of the lot-specific PT-reagent.

RATIO = patient sample in sec is divided by MNP in sec.

INR = International Normalized Ratio
ISI = International Sensitivity Index according to package insert

1. Enter the settings WITHOUT a PIN Code as described in chapter 6.6, page 58.
2. Enter the settings WITH a PIN Code as described in the following.

NOTE
Only if <None> has been selected for <1st conversion> an input
field to enter the MNP (mean normal plasma) value will
automatically be displayed for the INR/RATIO conversion under
<2nd conversion>.
In case of the aPTT-Method the 1st conversion is none and the MNP
has to be entered.
If the <Reference curve> is selected under <1st conversion> and
the reference curve consists of valid points, the MNP value is taken
from the reference curve. Thus, there is no option to set the MNP.

The following sub-menus can be selected if <reference curve> or <None> was selected
under 1st conversion.
Table 6-2 Overview 2nd conversion submenus

Selection Meaning

<INR> -→ MNP -→ ISI For calculation of the INR-value enter the ISI
according the given in the PT reagent leaflet
<RATIO> -→ MNP To enter the 100% MNP (only if <1st conversion>
is set to <None>.
<None> No conversion

 Press to access the submenu <2nd conversion>.

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6.7.3.1 Select <INR> and set the ISI value

1. Press and the following display appears:

2. Press and the following display appears:

3. Use number keys to enter the ISI-value and to set the decimal point.

4. Press to confirm the entry.

5. Press to access measuring or to set or verify more parameters.

6.7.3.2 Select <RATIO> and set MNP

If for <1st conversion> <None> is selected, the MNP has to be set to calculate the
RATIO.

1. Select 2nd conversion and press to confirm. The following display appears:

2. Use number keys to enter the MNP, use to set the decimal point.

3. Press to confirm the entry of normal time value.

NOTE
If the 1st conversion is active, the MNP value is not accessible in the
RATIO submenu.

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6.7.3.3 Set <None>

If <None> is selected no INR and no Ratio will be calculated. The result is only
displayed as the clotting time in seconds.

Menu <3rd conversion>

NOTE
For the methods D-Dimer 750nm, D-Dimer 405nm and AT 405nm a
3rd conversion is required. For these methods not the time upon
detection of clotting is measured but a kinetic. The resulting raw
value mE/min. is converted into a unit. e.g. % or ng/ml.
Evaluating the measurement results with 3rd conversion parameters
means that the results are calculated based on previously
determined calibration points or calibration values given in the leaflet
of the respective PT reagent.

 Parameters are set or adjusted the same way as described in the chapters before.

Table 6-3 Overview 3rd conversion parameter

Selection Meaning

<Reference curve> <falling> (AT 405nm)

<rising> (D-Dimer 405/750nm)
<Unit> Unit of reference curve to be entered with the text generator
xx/yy % (AT 405nm)
ng/ml (D-Dimer 405/750nm)
Decimal place <Format xxx.x> (AT 405nm)
<Format xxxx> (D-Dimer 405/750nm)
Min/Max value 3 / 150% (AT 405nm)
150 /2600 ng/ml (D-Dimer 405/750nm)
<Calibration Points> Conversion via a 9-point calibration, e.g.
97%, 1 point 11.5 mE/min (AT 405nm)
220 ng/ml, 1. point 21.0 mE (D-Dimer 405/750nm)
<Time interpolation> Linear (AT 405nm)
<Value interpolation> Reciprocal (AT 405nm)

NOTE
New entered reference curve data will be active if the changes are
safed. Otherwise measurement results will be evaluated by means of
previous settings, thus not necessarily plausible.

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Menu <Measurement>

CAUTION
Be aware, any modifications within this menu can cause different
measuring results!
To avoid incorrect measuring results only authorized personnel
should have access to the method parameterization!
After each entry a parameter protocol must be printed in order to
check the entry again!

 Press to access menu <Measurement>.

The following selections are available:

Table 6-4 Overview Measurement parameter

Selection Meaning

<Start reagent> To enter the start reagent volume and reagent Lot Number
<Incubation> To enter the 1st and 2nd incubation time
<Printout No.> To enter a Start-No. of print-out
<Mixer> Mixer starting speed - period of reduction until final speed is
reached - mixer final speed
<learn, lag> To enter learn and lag times
<Meas.time> Total measuring time
<t1 ; t2> Enter first and second time for calulating the kinetic reaction

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6.7.5.1 Set Start Reagent Volume/ Reagent Lot. Number

Example for Method <PT> reagent and Lot Number.

NOTE: Entry range: 1-250 µl.
The Lot. No. can have an maximum of 12 characters.
1. Enter the volume for the start reagent with the number keys, for example 100 µl.

2. Press to confirm the entry.

3. Enter the reagent Lot Number manually. You may enter a maximum of 12-digits
alpha numeric.

4. Press to confirm the entry.

NOTE
Alternatively, if a barcode scanner is connected:
 Scan the barcode label of the reagent vial (a max. of 12
alphanumeric digits is imported as string). The Software
automatically displays the next menu after the string was
imported and displayed for 3 seconds.

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6.7.5.2 Set Incubation time

NOTE
For the PT method, the first incubation time is set to 0 by definition.
The according value is assigned to the second incubation. If another
parameterization is set, the analyzer might change the measuring
procedure which could lead to missleading results and interpretation.

Example for PT-Method Incubation time of Start reagent.

NOTE: 0 s = no incubation, Max.: 600 s.

1. Enter the method-dependent 1st sample incubation time for 1st =0 s and 2nd =xxx s
with the number keys.

2. Press to confirm the entry.

6.7.5.3 Set Start number for Print out

The next display appears.

Example for PT-Method.

NOTE: Max.: 3-digits (1-999).
 Enter the start number for print out by using the number keys.

 Press to confirm the entry.

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6.7.5.4 Set Mixer function

NOTE
The mixer function is implemented to gently and properly mix
the sample (and reagent).
Information to method-specific settings are given in chapter 5,
page 38, Table 5-1.
Before modification consult your local distributor or the
manufacturer.

Example for Method AT-405

1. Enter the time period in sec = time from rpm1 to rpm2.

2. Enter the starting speed (0, 200 - 800 rpm).
3. Enter the end speed (0, 200 - 800 rpm).
In this example the measurement will start with 800 rpm (rpm1) mixer revolutions and
reaches 0 rpm (rpm2) after 5 seconds.

Figure 6-7 Exemplary function of mixer speed reduction

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6.7.5.5 Set <Learn-/Lag times>

Example for PT-Method.

 Here you can enter parameters for the optical detection of the sample.
 Learn 1…60 sec phase: Thresholds definition phase.
 Lag 0…60 sec phase: Time phase without measuring curve analysis.

NOTE
Before any modification consult your local distributor.

1. Press to confirm the entry.

2. Press to access measuring or to set or verify more parameters.

6.7.5.6 Set parameters for 3rd conversion

For 3rd conversion not the time of the clotting is measured but a kinetics.
Thus, two times, a start and an end time is necessary to calculate the difference.

 The cursor blinks on the first entry position.

1. Enter the measuring time with number keys.

2. Press to confirm the entry and jump to set t1 and t2.

 The cursor blinks on the first entry position.

3. Enter t1 with number keys.

4. Press to jump to t2 and also enter the time.

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5. Press .

6. Press until “checking parameters please wait" appears, then:

7. Press to save parameters or to leave the menu without saving the

changes.

8. Automatically STANDBY or the measuring mode is reached and the user can
proceed with the operation.

6.7.5.7 Set Minimum and maximum time

Here the minimum time after which a clot can be detected and the upper limit of clotting
detection can be set.

1. The cursor blinks on the first entry position for “min. time”.
2. Enter the “min. time” with number keys or confirm and proceed.

3. Press to confirm the entry and jump to “max. time”.

4. Enter the “max. time” with number keys or confirm and proceed.

5. Press to confirm the entry.

6. You jump automatically to the “meas. time” display.

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6.7.5.8 Set measuring time

Here the total measuring time, depending on the test method, can be set.

1. Enter the measuring time with number keys or confirm and proceed.

2. Press to confirm the entry.

3. Automatically the next display appears.

4. Press until “checking parameters please wait" appears, then:

5. Press to save parameters or to leave the menu without saving the

changes.

6. Automatically STANDBY or the measuring mode is reached.

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UTILITIES

Parameter access WITH PIN Code only

The menu UTILITIES includes a group of submenus in which analyzer settings can be
adjusted.
A "PIN Code" (default PIN 11111) is necessary to enter. It can be changed user-
specific later on in UTILLTIES submenu <PIN Code>.

Table 6-5 Overview UTILITIES Submenus

Selection Meaning

<Printer> Select: AUTO / ON / OFF and print parameter protocol

<Port A> Activates functions at the RS232-C
<Port B> Sends measuring results to HOST/LIS if “ON”.
Enables BC-Reader at Port A
If “OFF” the measuring results will not be sent to the HOST
<Beeper> Select: ON / OFF / CLICK
<Language> Select analyzer language
<Date/Time> Entry of Date and Time
<Reagent-Stirrer> ON: stirring with 250 rpm, OFF: no stirring
<PIN Code> Enter a personal PIN Code (secret number)
Entry range is from <00001> to <59999>
00000 = Off/ disable
<Cuvette-Test> Verification of automatic cuvette detection and electronic Start-
Pipette.
<Parameter Service: Load parameter onto SD-Card
im/export> Save parameter onto SD-Card
<Info> Shows information about the analyzer
<photometer Posibility to separately calibrate the photometer of the
calibration> measuring channel.

1. Switch on the analyzer.

2. In STANDBY <PT> press or until <UTILITIES> appears.

3. Press and enter the PIN Code (factory default: 11111).

NOTE
If the number was incorrect STANDBY display appears again. The
following display appears, provided the correct PIN Code was
entered.

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 Generally, after a SubMenu has been selected and adjusted, respectively, you are
asked to adjust more parameter or change to the measuring mode.

According display will appear.

4. Press to access the measuring mode (“cuv in”) or press to set or

verify more parameters.

SubMenu <Printer>
In this SubMenu you can select the print-out of different data, e.g. test results, method-
or analyzer parameters as well as error messages via the internal printer.
Furthermore, you can print also via an external printer if connected to the analyzer.
Table 6-6 Printer selections

Selection Meaning

<On> Printer is activated, manual printouts are

possible after measurement with
respective CHx key.
<Auto> Print of results automatically, as soon as
the test result is available.
<Parameter protocol> Print of Method- and global analyzer
parameter
<Global> Print of global analyzer parameter
<Actual Method> Print of method parameter of a selected
method
<All Parameter> Print of all analyzer- and method
parameter
<Off> Printer is deactivated

Printout <Parameter protocol> Actual method

Very often it is of interest, to have a look at the actual method parameters in order to
verify the measuring results.
The easiest way is to make a print-out as described in the following:

1. Enter UTILITIES and press or to switch to <Printer>.

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2. Press to enter the <Printer> menu.

3. Press or to select <Parameter-Protocol>.

4. Press to enter the <Parameter-Protocol> menu.

5. Press or to select <Actual Method>.

6. Press to automatically print out the actual method.

NOTE
To select and activate the actual method for the print out, the warm-
up time of the analyzer after “switch on” must be finished. Then,
select the required method, press and change via UTILITIES
to print out the actual method.

SubMenu <Port A>

The analyzer model is equipped with a 6-pin RS232-C interface at the backside of the
analyzer. This interface can be used for external data communication, to connect an
external printer or barcode scanner.
Table 6-7 Port A - Selections

Selection Meaning

<Off> RS 232-C interface ( Port A) is deactivated

<ext. printer> Serial output of data to an external printer

1. Enter UTILITIES and press or to switch to <Port A>.

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2. Press to enter the Port A submenus.

3. Press or to select among following options:

4. Press to confirm and activate respective option.

Following display appears:

5. Press to return to the measuring mode or press to set or verify

more parameters.

SubMenu <Port B> (virtual com port via USB)

To link the analyzer to a HOST see chapter 4.9, page 32 to connect the HOST to the
analyzer.

NOTE
If not already made available by the HOST operating system a USB
driver has to be installed previously on the HOST computer in order
to use the USB port.

 The analyzer offers an USB interface (USB Type B connector/Port B) at the

backside. This interface will be acknowledged as virtual COM-Port at the HOST
side (USB plug Type A). → see also chapter 4.9 Connection to a HOST (Port B),
page 32.
 The USB interface can only be used to connect the analyzer to a HOST. It is not
possible to connect an external printer.

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Table 6-8 Port B - Selections

Selection Meaning

<OFF> Interface is switched off

Serial Port B is activated for HOST communication.
The analyzer changes into a state that a barcodescanner can be
connected
<HOST> If a HOST is activated/connected to the analyzer the software
requests a patient barcode number. The number input can either
be carried out by entering the number manually (numerical data) or
by a barcode scanner (alpha numerical).

If a LIS application is installed on your HOST, the following order is necessary:

1. Switch on the HOST and wait until it is booted.
2. Switch on the analyzer
 Wait approx. 30 sec. until the HOST has detected the USB connection. If available
and activated a sound indicates the identification of the analyzer.

3. Then open the LIS or other software application at the HOST side.

If the analyzer has been switched off in the meantime and has to be switched on again,
follow the described order:
1. Stop the user software (close the program).
2. Switch on the analyzer.
3. Wait until the computer has identified the analyzer (beeps if sound are “on”).
4. Then start the user software.

Options in the analyzer settings

1. Off
2. HOST – measured results to be send in a formatted string to HOST.
 Output example general:
<STX> Analyzer; S/N; Date; Time; Patient ID; Method_Name; Channel No; Raw
Value1; R_Unit1; Raw Value2; R_Unit2; 1st Conversion; 1_Unit; 2nd Conversion;
2_Unit; 3rd Conversion; 3_Unit; Flags; CRC;<CR><LF>
 Output example for PT method with normal Plasma:
<STX>CoaDATA 4004; G1560001; 17.10.2016; 13:19:23; 147; PT; 1; 12,3;s;
89,7;%; 1,06;Ratio; void;void; OK; CB90;<CR><LF>
 Output example for aPTT method with pathological Plasma
<STX>CoaDATA 4004; G1560001; 17.10.2016; 13:34:22; 1895; aPTT; 1; 88,2;s;
void;void; 3,15;Ratio; void;void; OK; D334;<CR><LF>
 HOST output Flags
o M = Mixer Motor (measurement stops, critical error)

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o S = Stirrer Motor (warning)

o T = Temp (warning)
 OK = no flag
Set respective interface parameters in the User software (see “Options to set the
analyzer settings”, point 3) as described in the following:

1. Enter UTILITIES and press or to switch to <Port B>.

2. Press to enter the Port B submenus.

3. Press or to select among following options:

4. In this case press to set Port B to HOST.

 Automatically the next display appears:

5. Press to set more parameters or press to return to STANDBY and

measuring mode.

 The analyzer checks the parameters.

 If parameters are unchanged the following message appears:

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If parameters are different to the previous ones:

6. Press to save new parameters and continue with the measurments.

7. Press to return to the measuring mode without saving the changes.

 Automatically the next display appears.

At this point the measuring can be started.

SubMenu <Beeper>

The beeper acoustically confirms:

 Key functions upon confirmation.
 An incorrect process.
 The finished sample incubation.
 The coagulation recognition.

1. Enter UTILITIES and press or to switch to <Beeper>

2. Press to enter the Beeper submenus.

Table 6-9 Beeper selctions

Selection Meaning

Activates the beeper.

<On>
Each action is confirmed by the beeper
<Off> Deactivates the beeper.
Only keysrtokes will be confirmed by the
<Click>
beeper

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SubMenu <Language>

This menu allows you to select different analyzer software languages.

The Default language is English.

Table 6-10 Language selections

Selection Meaning

<English> Set analyzer language to English

<German> Set analyzer language to German

<Español> Set analyzer language to Spanish

<French> Set analyzer language to French

<Portuguese> Set analyzer language to Portuguese

<Russian> Set analyzer language to Russian

1. Enter UTILITIES and press or to switch to <language>.

2. Press .

3. Press or to select the required language.

4. Press to confirm the selected language.

5. Press to save the selection or to return without changes.

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After that:

6. Press to return to the measuring mode or

7. Press to set more parameters.

SubMenu <Date/Time>
In this menu you can set the actual date and time of the analyzer.

1. Enter UTILITIES and press or to switch to <Date/Time>

2. Press .

 The cursor blinks on the first character, the format is fix (dd.mm.yy, and hh:mm:ss).
3. Press respective number keys to enter date and time (from left to right).

4. Press to jump to the next number/ character.

 The cursor automatically blinks on next number/ character.

 There is no need to enter a decimal point.
5. Proceed with the adjustments until the last entry is reached.

6. Press .

8. Press to return to the measuring mode, the analyzer checks the parameters.

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9. Press to save or to return to the measuring mode.

 The analyzer switches to the measuring mode of the last method set.

SubMenu <Reagent-Stirrer>

The Reagent stirrer is set to <On> by default. The stirring speed is 250 rpm.
 Stirring only takes place in the measuring mode (“cuv in”), in STANDBY the motor
switches off.

1. Enter UTILITIES and press or switch to <Reagent-Stirrer> .

2. Press or and select <Off> to disable the stirring function.

3. Press to confirm the selection or return to the measuring mode.

4. To enable the stirring select <On> and press to confirm.

5. Press to return to measuring mode.

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SubMenu <PIN Code>

A PIN Code can be entered to prevent inadvertent parameter changes of non-
authorized personnel.

Without entering a PIN Code it is possible to:

 Perform all tests.
 Select the test method.
 Set / adjust the conversion parameter and reagent Lot Number.

With a PIN Code it is possible to:

 Perform all tests.
 Select the test method.
 Set / adjust the conversion parameter and reagent Lot Number.
 Have full access to all method parameters.
 Have full access to all parameter in the menu <UTILITIES>.

 This menu allows you to select a PIN Code (secret number) of 5 digits to access
the parameter and UTILITIES menu.
 Entering <00000> will disable the PIN request.
 Entry range is from <00001> to <59999>.
 After the PIN Code has been entered, the following display appears:

The default PIN set by the manufacturer (11111) can be overwritten at this point.
1. Enter the PIN Code with number keys.

2. Press to confirm the entry, parameters are checked.

3. Press to confirm the entry or to return to the measuring mode.

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 If changes are saved a print out will follow if printer-mode is set to Auto.

-----------------------------
<Analyzer name>
Ser. No. B1770711 Example print-out!
PIN No. =xxxxx x = Number
-----------------------------

NOTE
If 5 times a 0 “zero” is entered and saved, the PIN Code is not
required to enter the parameter or UTILITIES menu.
In any case, the PIN Code must have 5 characters.

 The analyzer switches automatically to STANDBY of the last method set.

SubMenu <Start-Pipette>
In this menu you can activate an electronic Start-Pipette. See also chapter 4.11
Connecting an electronic Start-Pipette, page 36 for further information.

1. Enter UTILITIES and press or to switch to <Start-Pipette>.

2. Press to enter the submenu.

3. Select <On> to activate or <Off> to disable the electronic Start-Pipette.

4. Press or to select.

5. Press to confirm the selection.

6. Press to return to the measuring mode.

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SubMenu <Cuvette-Test>
This menu checks the function of the automatic cuvette recognition. To perform the
cuvette test some conditons have to be fulfilled before.
 The thermal block has to be warmed up to operating temperature.
 The “photometer check” has to be finished sucessfully.

1. Enter UTILITIES and press or to switch to <Cuvette-Test>.

2. Press to select <Cuvette test> and the following display appears:

3. Insert a cuvette into each measuring channel.

 The transmission threshold value is used to decide whether a cuvette is inserted or
the light path is free of cuvettes.
 If a cuvette is inserted into the measuring channel, the display shows “cuv” in the
according channel in case of cuvette detection.

 When removing and inserting the cuvette alternately, the display must show the
appropriate status “cuvette” and “- - -“.

In case the function does not operate as described above.

1. Remove all cuvettes from the measuring channels.

2. Switch OFF the analyzer.

3. Wait about 1 minute.

4. Switch ON the analyzer.

5. Repeat all the steps described above a second time.

If the Cuvette-Test is carried out but the thermal block has not reached its final
temperature the following appears on the display:
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 Wait until the temperature of 37.4°C is reached and the photometer calibration is
finished. Then carry out the test again.

SubMenu <Parameter import>

It is possible to import reagent and method data by use of a SD-card.
An already defined method with the same name is overwritten automatically.
At the end of this procedure modifications can be saved or skipped.
All parameters can be imported from a file named PARIMP.TXT onto the analyzer.
To execute this function a fat32 formatted SD-Card must be inserted into the analyzer
SD-Card slot.
Formatting the SD-Card is only possible with a special software because windows does
not support the formatting process properly.
Please visit: www.sdcard.org/downloads

Insert the SD-card

1. Insert a SD-Card into the card reading unit located on the rear side of the analyzer.
2. Ensure that the SD-Card latches in the card reader.

3. Enter UTILITIES and press or to switch to <Param. im/export>.

4. Press .
5. Select < Import <-SD-Card>.

6. Press .

 The parameter import starts automatically with according message.

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 The parameter file of the SD card is imported automatically.

 Subsequently, the display shows the next submenu.

7. Press to return to STANDBY of the respective method.

 The analyzer checks the parameters.

 If parameters are unchanged the following message appears:

If parameters are different to the previous ones the display shows:

8. Press to save new parameters and continue with the measurments.

9. Press to return to STANDBY without saving the changes.

Remove the SD-card

 Slightly press the outer visible face of the SD-Card into the analyzer.
 The pressure causes the internal ejector mechanism to release the SD-Card.

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SubMenu <Parameter export>

All parameters can be exported to a file named PAREXP.TXT onto SD-Card.
To execute this function a fat32 formatted SD-Card must be inserted into the analyzer
SD-Card slot.
Formatting is only possible with a special software because windows does not support
the formatting process properly.
Please visit: www.sdcard.org/downloads
Another possibility is to use a camera to format the SD-Card. See corresponding User
manual to carry out the formatting.

NOTE
Make sure the SD-Card does not carry any additional adhesive
stickers this could harm the card reading unit.
The write protection of the SC-Card has to be unlocked otherwise no
data can be exported.

1. Insert a SD-Card into the card reading slot located on the back side of the analyzer.
2. Ensure that the SD-Card is inserted and pushed into the card reader as far as
possible.

3. Enter UTILITIES and press or to switch to <Param. im/export>

4. Press .
5. Select < Export - > SD-Card>.

6. Press .
 The parameter export starts automatically with according message.

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 Export of parameter from the analyzer to the SD-Card.

 The parameter file of the SD card is exported automatically.
 Subsequently, the display shows the next submenu.

7. Press to return to STANDBY of the respective method.

 The analyzer checks the parameters.

 If parameters are unchanged the following message appears:

If parameters are different to the previous ones the display shows:

8. Press to save new parameters and continue with the measurments.

9. Press to return to STANDBY without saving the changes.

Remove the SD-card

 Slightly press the outer visible face of the SD-Card into the analyzer.
 The pressure causes the internal ejector mechanism to release the SD-Card.

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SubMenu <Info>

This submenu has the purpose to show the user:

 Name of the analyzer
 Current software version
 Date of release of software version
 Serial number of the analyzer
 Parameter ID number
 Number of NTC-T (temperature calibration value)

 Press or to switch between lines.

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SubMenu <Photometer calibration>

In this menu the user has the posibility to separately calibrate the photometer channels.

1. Enter UTILITIES and press or to switch to <photometer calilbr.>.

2. Press .

3. Remove all cuvettes and close all light protection caps.

 After a few seconds the inext display appears.

4. Press the channel button e.g. CH2 to calibrate the respective channel.

5. Press to return without calibration.

 If the calibration is finished the previous display appears.

 Only with you can return to the UTILITIES submenus.

 Thereby the parameters are checked and either stored with or rejected

with

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 The analyzer returns automatically to UTILITES.

Sample print-outs PT and calibration

General print-outs

Once a method has been selected the programmed calibration curve parameters will
be printed out followed by the results.
The print-out is done automatically as soon as a result has been obtained by the
measuring channels CH1 and CH2 resp. CH3* und CH4* (*= only at 4-channel)
Each method has its own counter. As soon as the analyzer has been switched on, the
counter starts with "1". This feature can be set in menu <Method-Parameter>,
<Measurement>, <Printout No.>.

Print-out of all parameters

A print-out of all programmed test parameters can be generated as described in

chapter 4.3 UTILITIES.

Print-out of method parameters

To generate a parameter print-out for the selected method, press “0” when the analyzer
is in the measuring mode.
However, the printer must be set to <On> or <Auto> in the UTILITIES menu <Printer>.

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Print-out of method PT (example)

Conversions via a 4-point calibration curve in % and INR.

--- method store 1 ---
`PT´
Date 27.01.17
Meas time = 420 s
Cuv in ON Automated cuvette detection
Start-Reagent
Lot = 101xxx Reagent-Lot. No.
Volume = 100 ul Reagent Start Volume
incubat. = 60 s Incubation time
1st convers INTERPOLAT 1. conversion, calib. curve /
interpolation
97.0%= 11.5 s Calibration curve points
43.0%= 20.1 s
23.0%= 31.9 s
12.0%= 57.0 s
2nd convers INR 2. conversion INR
ISI = 1.05 ISI-constant

-----------------------
Results:
PT Method
Patient _____________ Patient name
27.01.2017, 09:01:11
Date, Time
No. = 1 Print.-out no.
Channel= 4 Channel No. 4
Time = 12.0 s Measuring time
% = 90.4 Conversion to PT %
INR = 1.06 Conversion to INR

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7 TROUBLESHOOTING

Faults may caused by actions during use and/or by the system. The analyzer displays
error messages and warnings in the display and prints out information when the
internal printer is activated, see chapter 6.8.1 SubMenu <Printer>, page 93.

Application errors

Application errors may cause error messages. Possible causes are:

 Air bubbles were created during pipetting.
 Pipetting was performed directly into the measuring channel without cuvette.
 Wrong pipette tips were used.
 The pipetted volume is incorrect (for variable pipets).
 The pipetting process was too slow or the angle incorrect.
 The temperature of the start reagent deviates from 37,4°C.
 Cuvettes are not prewarmed / too cold for plausible measuring.
 The reagent has been placed incorrectly.
 The sample or control is too old.
 No mixer has been placed into the cuvette.
 Reagent carry over (e.g. PT reagent).
 A reagent with the wrong Lot Number has been used.
 The reagent has not been used according to the package insert.
 The reagent used does not correspond to the method selected.
 Start reagent has not been reconstituted and / or mixed properly
 No or an incorrect calibration curve is available.

 Errors appeared during the sample collection or centrifugation.

 No stirrer is placed into the reagent vial.
 Method parameters relevant for measuring are incorrect.

Should any of these errors occur and they are recognized in time, they must be solved
immediately.

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Cancel incubation / measurement

If you realize wrong handling and want to interrupt the measurement stop the
measurement with the following key combination.

 Press + at the same time to stop the measuring process on the

respective channel.

Status messages cuvette balance

Status message
Cause Action
(display/print)

Balance and reserve The cuvette balance and Insert new CuvCARD and
fully used. reserve quantity is now fully load new balance to
used, no further measurement analyzer, once the
possible cuvette balance and
reserve quantity is fully
used.
Balance fully used! The cuvette balance on the Insert new CuvCARD and
analyzer is now fully used, no load new balance to
further measurements analyzer, once the
possible. cuvette balance is fully
used. Make sure always
having enough cuvettes
on stock.
CuvCARD devalued! Cuvette balance on CuvCARD Use new CuvCARD
is fully used, CuvCARD is delivered with cuvettes
empty! boxes.
Make sure enough
cuvettes are available.
Only xx measurements Message shows the remaining Perform remaining
remaining. quantity of measurements left number of
to utilize. measurements, when
used, insert new
CuvCARD and load new
balance to analyzer.
Make sure enough
cuvettes are available.
Only xx reserve Message provides information, Insert new CuvCARD and
measurements remain that only a certain reserve load new balance to
possible. quantity is left to utilize. analyzer, once the
reserve quantity is fully
used.
Make sure enough
cuvettes are available.
Only a few Message provides information, Insert new CuvCARD and
measurements remain that only a small reserve load new balance to
possible. quantity is left to perform. analyzer, once the
cuvette balance is fully
used.
Make sure enough
cuvettes are available.
Please order new Note; balance and reserve will Timely order new

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cuvettes. run short soon. cuvettes to be able

continuing
measurements.

Error messages with respect to turbity in sample

Error message
Cause Action
(Display)

break time Possibly no clotting; Optical test for clots;

The maximum measuring time repeat test
has been exceeded.
break top Exceeded measuring range (too Repeat test
high) possibly caused by air
bubbles
break bott(om) Exceeded measuring range (too Repeat test
low) preparation becomes turbid
break moto(r) Mixer motor error occurred Contact technical
service
break nois(e) Signal too noisy after sample Check for air bubbles or
adjustment other particles, e.g.
mixer fallen out of the
cuvette into the channel.
break drft (drift) Measured curve drifted after Check sample for air
reagent has been added or start bubbles or if start
pipette error. pipette is activated in
soft-ware but not linked
to analyzer
break adj(ust) Light value is too dark during Check sample and try
adjustment phase again
break Measurement cancelled with Intentionally done by
user!
+
Bright value failed Channel is not free, e.g. Remove the cuvette
remaining cuvette, dust or other Clean the channel
debris disturbs the light path
Then press ENTER to
retry or ESC to go to the
next channel
If necessary call the
technical service.
CuvCard or ChipCARD Parameter checksum on Contact technical
Checksum error! inserted card type is incorrect service

CuvCard or ChipCARD Inserted card type may be Re-insert card and

Reading error! defect. repeat process,
otherwise contact
technical service
Please remove Utilized CuvCARD may not Try another CuvCARD
ChipCARD carry cuvette credit or is a or contact technical
ENTER: continue wrong card. service.

Invalid customer ID Customer ID number on Contact distributor

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Error message
Cause Action
(Display)
No booking done! CuvCARD does not correspond
to cuvette type used.
Empty/invalid card Inserted ChipCARD could not Repeat process or use
be read due to possible other ChipCARD.
incorrect or no data being on Contact distributor.
the card.
Write error An error occurred while writing Contact technical
No booking done data to card. service

Wrong cuvette type Cuvette type on cuvette card Contact distributor

No booking done! does not correspond to cuvette
type on analyzer.
Warning: ChipCARD Reading Error Insert the ChipCARD
Error! with the correct direction
ChipCARD is inserted upside
ENTER: continue Insert correct blanko
down
ChipCARD
Wrong blank ChipCARD has
Insert correct Method
been inserted
ChipCARD
Wrong Method ChipCARD has
been inserted
Invalid version of ChipCARD
has been inserted
WARNING: Please A card still remains in the card Remove card and press
remove ChipCARD! reading unit ENTER to continue
WARNING: Wrong ChipCARD with Use ChipCARD with
incompatible incompatible method data was method data compatible
method inserted into the analyzer. to the analyzer
software.
SD-CARD is write- The SD-Card is locked Unlock the write-
protected protection of the SC-
ENTER: continue Card

CD12 <BOOTLOADER Inserted SD-Card is locked after Remove the power

V1.0 connecting the analyzer to the supply cable, then
power = starting. remove the SD-Card,
unlock the SD-Card,
insert the SD-Card and
attach the power supply
cable to start the
analyzer again.
Invalid method param Method parameters entered are Check method
incorrect. parameters.
New name cancelled Method name was entered Enter method name
incorrectly. again.
No card! There is no ChipCARD or Insert correct Card to
CuvCARD inserted in the card card reader.
reader.
No SD-Card detected. SD-card could not be read. Check SD-Card,
perhaps use another
card instead.
No SD-Card found. While trying to access to SD- Insert SD-Card to

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Error message
Cause Action
(Display)
Card card was not found. analyzer.
Blinking P in the right Write protection of the SD-Card Remove the SD-Card
upper corner of the is activated. Remove the SC-Card,
display. unlock the write
portection and insert the
SC-Card again.
Parameter error! While loading parameters an Check parameters and
set to defaults error occurred. System default re-enter if necessary.
parameters loaded instead.
Printer module missing! While initialization of analyzer Switch Off/On analyzer
printer communication failed. and try again. Contact
technical service if
problem persists.
SD-Card write- The write protect on the Deactivate write protect
protected! Memory Card has been on the Memory Card
activated. and repeat the
operation.
SD-Card: Initialization Initialization error while writing Repeat process,
error! data to a card. perhaps use other card
instead.
SD-Card: Root directory SD-Card defective or incorrectly Use other card or try to
error! formatted. initialize.
Write Error! Data can not be written to SD- Card defect, wrong card
card. used or not correctly
inserted. Retry. Contact
technical Service if
problem persists.
WARNING: HOST not PC is not connected. 1. Switch on the HOST /
connected USB driver is not installed. PC.
PC and analyzer are switched 2. Switch on the
on in the wrong order. analyzer.
3. Set the analyzer to
STANDBY.
4. Install a USB driver.

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Errors during operation

Error Cause Action

Cannot start analyzer Power supply failure. Check the function of

Loose power cable. the power supply.
If the power supply is
ok but the analyzer
does not work, contact
your local distributor or
the technical service.
Analyzer fails during Power supply failure. Check the function of
operation Loose power cable? the power supply.
Mains power failure. If the power supply is
ok but the analyzer
does not work, contact
your local distributor or
the technical service of
the manufacturer.
Measuring cells Additional pipetting of plasma or Remove liquid with
contaminated with reagent into the measuring cell pipette, clean with
liquids without cuvette. appropriate absorbent
cloth and disinfectant.

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Warnings

Warning Meaning Action

Cool down This message will appear Might occur due to direct
when it is determined while sunlight, place the analyzer to
no measurements are another place with lower light
running that the incubation input.
block is too warm. No other Contact technical service.
measurements can be
started during cool down.
WARN: Temp. If during a measurement the Might occur due to direct
instabile temperature of the incubation sunlight or , current place the
(TEMP WARN) block deviates significantly analyzer to another place with
from the set value, the lower light input.
measurement is not Contact technical service
cancelled. Instead this
warning appears in the
display and is also printed
out via the active printer.
Err over This message appears if a Check conversion
(calculation calculated measuring value If the err over message is
overflow) cannot be displayed displayed check the
(calculation overflow) parameterization of the
(in display and
because of size overflow. calibration curve parameters
printout)
The err over message can
appear during:
extrapolation of the 100 %
calibration curve value
interpolation of a measuring
value based on the
calibration curve
calculation of the coefficient
of variation.
ERR div0 Measurement calculation Check adjustments on Time
detetced a negative value. Interpolation and Value
interpolation.
Repeat measurement and
check reference curve.
ERR no clot No clotting detected during Check sample and method
measurement. parameter settings, repeat
measurement.
ERR log0 Measurement calculation Check adjustments on Time
detetced a negative value. Interpolation and Value
interpolation
Repeat measurement and
check reference curve.
ERR bright-calib An error has been detected Remove all cuvettes from
ch%u: during bright calibration. measuring channels and repeat
Bright calib failed! adjustment. Might occur due to
direct sunlight, place the
analyzer to another place with
lower light input.

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Warning Meaning Action

Close light protection cap.
Contact technical service is
problem persists.
ERR dark-calib An error has been detected Remove all cuvettes from
ch%u: during dark calibration. measuring channels and repeat
Dark calib failed! adjustment. Contact technical
service is problem persists.
Might occur due to direct
sunlight, place the analyzer to
another place with lower light
input. Close light protection
cap.
max-time reached If during the input of
no more points calibration curve points a
point is defined that equals
the maximum measured
time, no additional points can
be entered as they need to
increase from point to point.
Input will be blocked when
this message appears.
min-value reached During the input of the
- no more points calibration curve, the range
of values (%, g/l, mg/dl) Is
limited for each method due
max-value reached to factory settings. In addition
- no more points the points must increase or
decrease depending on the
presetting. If the largest or
smallest permitted value for a
point has been entered, no
additional points can be
entered. Input will be blocked
when this message appears.

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8 MAINTENANCE AND HYGIENE

Safety

CAUTION
 Do not use organic acids to clean the analyzer.
 Do not spray or pour on any liquids, as they can affect the
correct function of the analyzer or damage it.
 Keep the analyzer free from dust and liquid spillages. When
not used over a longer period of time, place a dust cover over
the analyzer or place it into a cabinet.
If liquid has been spilled on the analyzer.
 Remove the contamination with a clean, absorbent non-woven
cloth considering all applicable hygienic requirements.
If liquid has accidentally entered, or been pipetted into a measuring
channel:
 Remove the liquid with a pipette, then clean the measuring
channel with a lint-free cloth.
 Consider all applicable hygienic requirements!
Contact our technical service if subsequent control measurements
do not produce the expected result.

NOTE
The analyzer is fitted with a lithium battery type Li-Mn CR 2430 (life
approx. 5 years). It should be replaced by an authorised service
operator after 5 years at the latest. Otherwise a faultless operation
can not be guaranteed.

BIOLOGICAL RISK
 The light protection caps are considered to be potentially
contaminated. Therefore, the manufacturer recommends to
replace the light protection caps once a year. Contact your
local distributor for further information.
 With the application of different reagents, and here especially
reagents containing thrombin, there is a risk of reagent carry-
over.
 If liquids or dried-on remnants can be seen on the rim of the
opening of the light protection cap, remove them with
laboratory disinfectant solution and lint-free cotton buds.

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User Manual CoaDATA 2004/4004

Operating and auxilliary materials

Disinfectant
 96% Ethanol, denatured.
 To clean and disinfect the analyzer (Thermal block, working area)

Hand protection
 Disposable nitrile rubber gloves.
 Avoid any hand contact with potentially infectious material / washing or cleaner
solution.

Eye protection
 Safety eye glasses.
 Splashes are likely to occur, there is a risk of infection.

Other
 Lint-free cloth.

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User Manual CoaDATA 2004/4004

9 TRANSPORT

If you should have thrown away the packaging material, please contact the
manufacturer, see chapter 1.1, page 7.
See also chapter 4.3 for further information.

Prepare the analyzer for packaging

NOTE
Clean and disinfect the analyzer before packaging.
Take care when moving the analyzer.
Secure the analyzer in the carton against slipping and tilting.
There are no special signs regarding the transport of the analyzer.

1. Remove cuvettes incl. mixer.

2. Remove all vials and adapters
(if inserted).
3. Remove printer cover and paper
roll, if inserted.

NOTE
Do not leave any loose parts inside
the analyzer!

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User Manual CoaDATA 2004/4004

Pack the analyzer for shipment

1. Open the box

2. Take the two card boards and

and place them onto the bottom
for stabilization (if not still
inside)

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User Manual CoaDATA 2004/4004

3. Fold the flat card box

4. Insert film card support box

5. Place the empty accesory box
and the folded card box onto
the right side.

NOTE
The film has to point upwards!

6. Take power plug (above) and

power supply (below).

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User Manual CoaDATA 2004/4004

7. .... and put them into the box.

8. Place the double air cushion

into the box between power
plug and power supply.

9. Place the single air cusion on

top.

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User Manual CoaDATA 2004/4004

10. Take the film bag and place the

analyzer into the bag.

11. Place the analyzer onto the

membrane packaging.

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User Manual CoaDATA 2004/4004

12. Place the upper membrane

packaging with the film
downwards (film facing to the
analyzer) onto the analyzer.
13. This way the analyzer is
stabalized and fixed against
slipping during transport.

14. Close the cover of the box and

seal it with packaging tape

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User Manual CoaDATA 2004/4004

10 SERVICE INFORMATION SHEET (CUSTOMER COMPLAINT)

NOTE
Please request a Return Authorization Number prior to any return
shipment.
For proper handling of a complaint please make sure the following
information is available.
 AnalyzerType (Name Plate)
 Serial Number of the analyzer (Name Plate)
 Model (Name Plate)
 Problem Description
 If available a picture of the defective part

Furthermore, we recommend to keep a service log book to document

maintenance work with information about date, reason and operator/
responsible person.
This makes the life cycle of the analyzer clearly visible and traceable.

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User Manual CoaDATA 2004/4004

11 DECOMMISSIONING AND STORAGE

If you intend not to use the analyzer over a longer period of time follow the instructions
as described.

CAUTION

1. Remove power plug from the socket.

2. Remove the power supply from the analyzer.

3. Remove all loose items as cuvettes or vials from the

analyzer.
4. Dispose vials with reagents and/or plasma according to
given disposal specifications.
5. Clean / desinfect the analyzer surface properly with
Ethanol (96%, denatured).
6. Let the analyzer dry for a certain time to get rid of any
possible remaining liquid.

7. Insert red cuvettes (the same when delivered) into the

measuring channels as dust protection.
8. Put the analyzer into a film bag.
9. Put the power plug and power cable into a film bag.
10. Store the analyzer and additional items at a safe, dry
place.

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12 DISPOSAL OF THE ANALYZER

CAUTION
For the safety of the operating personnel make sure the analyzer has
been disinfected before disposal.

 All parts parts must be disposed of in accordance with national directives for
disposal.
 Do not dismount and recylcle the analyzer by yourself

 For disposal send the analyzer to a registered waste disposal authority or contact
your local distributor

1. Remove the power supply plug from the socket.

2. Remove the power supply plug from the analyzer.

3. Remove all loose items, e.g. cuvettes or vials from the analyzer.

4. Clean / disinfect the analyzer properly with Ethanol (96%, denatured).

5. Let the analyzer dry for a certain time to get rid of any possible remaining liquid.

6. Put the analyzer into a film bag.

7. Put power suplly plug and power supply cable into a film bag.

8. Prepare the analyzer for transport as described in Chapter 9 Transport, page 123.

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User Manual CoaDATA 2004/4004

13 APPENDIX

Technical data

System related

Characteristics Description

Type of analyzer Semi-automated 2/4-channel in-vitro diagnostic analyzer for

coagulation
Application Measurement of chromogenic assays and clotting tests
Operation Described in this User Manual
Measuring principle Photometric (transmission), turbodensitometric
Sensitivity ~ 1 g/l Fibrinogen
PT > 10% of norm
Test throughput ~120/h PT (4-channel), ~60/h aPTT (4-channel)
~60/h PT (2-channel), ~30/h aPTT (2-channel)
Cuvette volume min. 150 µl, max. 200 µl (suspension)
Calibration Manual input of calibration points, method dependent
Software Stored in memory
Programmed methods PT, in sec, %, Ratio, INR (combinations)
aPTT, in sec, and Ratio
Fibrinogen, in sec, g/l and mg/dl
Thrombin Time (TT), in sec
D-Dimer 405/750nm
AT 405
Intr. Factor, in %, Extr. Factor, in %
Light source LED photometer 405 and 750 nm
Display Liquid crystal display, 2 lines with 20 characters each
Thermal block Temperature controlled at +37.4°C +/- 0.4°C
Measuring channels 2/4
Light protection caps 2/4 (designed for yellow pipette tips by Eppendorf)
Reagent positions 4 positions á 32 mm diameter
Cuvette positions 18 (2-channel), 16 (4-channel)
Measuring time Max. 420 sec
Interfaces RS232-C, USB-B, SD-Card, CARD reader, electronic Start-
Pipette
Printer Internal thermal printer, 26 characters/line
System time Real time clock for time and date
Dimensions Approx. 260 x 330 x 110 mm (LxWxH)
Weight Approx. 2.60 kg

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Electrical data

Parameter of external power

Value / Range
supply

Input voltage 100 – 240 VAC

Rated input current Approx 2.5 - 1.0 A
Rated input frequency 50-60 Hz +/- 3Hz
Output voltage +24 VDC
Output current Max. 3.75 A
Power consumption Max. 90 VA

Parameter Analyzer Value / Specification

Input voltage 24 VDC

Max. input current Max 1.36 A
Overvoltage category I
Degree of contamination 2
Protection class Class III

Environmental requirements

Parameter Description

Usage Inner rooms only, dry environment

Altitude  2.000 meters
Mains voltage fluctuation Max.  10% of rated voltage
Pollution degree Class 1
During operation; +15°C - +30°C
Temperature
During transport and storage + 2°C - +50°C
Humidity 10% - < 85%, non-condensing

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User Manual CoaDATA 2004/4004

Disposables

Type Menge Material

Cuvettes 5 x 100 Micro Cuvettes / Dispo-System with Mixer

1,0x4 mm
1x CuvCARD
1 x 500 Micro Cuvettes / Mixer 1,0 x 4,0 mm in
plastic bag
1x CuvCARD

Thermal 1 x 10 rolls, boxed Printer - / thermal paper 57 mm

paper

Materials supplied

Menge Material

1x CoaDATA 2004 / 4004

1x Printer cover
1x 100 cuvettes in dispo system
1x Reducer ring
1x Operator manual on USB stick
1x Thermal paper
1x External power Supply
1x Power cable

Optional equipment

 Barcode scanner
 Cable for barcode scanner
 USB driver (if not already available at HOST)
 Teflon reagent stirrer

Supplier documentation

 Barcode scanner
 USB driver

13 Appendix 134