User Manual Dca-1

User Manual
DCA-1
For in-vitro diagnostic use only!

User Manual DCA-1
Revision History:
Version Analyser
Date Software-
Manual Comment
(yyyy/mm/dd) Version -
(Art.-No.) Release -
01.00 V1.0, Feb. Initial

2019-03-22
(105-96-300-00) 8, 2019 version
01.01 V1.0, Feb.

2019-07-31 update
(105-96-300-01) 8, 2019
01.02 V1.0, Feb. Minor

2019-08-08
(105-96-300-02) 8, 2019 change
Revision History 2
User Manual DCA-1
Content
1 IMPORTANT INFORMATION 8
Definition OEM / PLD 8
Liability Disclaimer 8
Software Copyrights 9
Intellectual Property 9
Warranty 9
Exclusions of manufacturer’s warranty 10
Guidelines for getting service assistance 11
2 TERMS, ABBREVIATIONS AND SYMBOLS USED IN THIS MANUAL
13
3 SAFETY 16
Duty of care of the user 17
Intended use 17
Reagents 19
Safety instructions 19
Electrical safety 19
Mechanical safety 20
Reasonable foreseeable and remaining risks 20
Emergency and first aid 21
Fire fighting 21
4 INSTALLATION 22
Name Plate (Serial no.) 22
Component overview 23
Software 23
Mounting and connecting the analyzer 24
Thermal block and User interface 26
Content 3
User Manual DCA-1
External printer 28
Connection to an external Printer (Port A) 28
Activate and deactivate the external printer 30
CuvCARDs - Load a cuvette balance (optional) 31
ChipCARDs – Store or load methods 36
Connection to a HOST (Port B) 37
Connecting an external Barcode Scanner 38
5 ANALYZER AND METHOD PARAMETERS 41
Instrument parameters 41
Method memory positions and Default Method Parameters 42
6 OPERATION 44
Measuring principle 44
User qualification 45
Switch on the analyzer 45
STANDBY 47
Method selection 48
Measuring Mode (= “cuvette in”) 48
Measuring Mode (= “Patient ID”) 49
Carry out a PT Measurement 51
Carry out an aPTT Measurement 54
Carry out a Fibrinogen Measurement g/l 58
Parameter configuration - Access WITHOUT PIN 61
Calibration curve 61
Set calibration curve points for PT 62
Set calibration curve points for Fibrinogen 64
Set MNP value 66
Save parameters 67
Parameter configuration - Access WITH PIN 68
Menu <General> 69
6.6.1.1 Method name 69
Content 4
User Manual DCA-1
6.6.1.2 Load default 72

6.6.1.3 Copy method 74
6.6.1.4 Exchange method 76
6.6.1.5 Read from ChipCARD 78
6.6.1.6 Write to ChipCARD 80
Menu <1st conversion> 83
6.6.2.1 <None> 85
6.6.2.2 Set <Reference curve> 85
6.6.2.3 Set <Unit> 86
6.6.2.4 Set <Decimal place> 86
6.6.2.5 Set Min/Max value (Conversion limits) 87
6.6.2.6 Set calibration points 87
6.6.2.7 Set <Time Interpolation> 89
6.6.2.8 Set <Value Interpolation> 89
Menu <2nd conversion> 90
6.6.3.1 Select <INR> and set the ISI value 92
6.6.3.2 Select <RATIO> and set MNP 93
6.6.3.3 Set <none> 93
Menu <Measurement> 94
6.6.4.1 Set Start Reagent Volume/ Reagent Lot. Number
95
6.6.4.2 Set Incubation time 96
6.6.4.3 Set Start number for Print out 96
6.6.4.4 Set Mixer function 97
6.6.4.5 Set <min value> 98
6.6.4.6 Set <Learn-/Lag times> 98
6.6.4.7 Set Minimum and maximum time 99
6.6.4.8 Set measuring time 99
UTILITIES 101
SubMenu <Printer> 103
Content 5
User Manual DCA-1
SubMenu <Port A> 105

SubMenu <Port B> (virtual com port via USB) 106
SubMenu <Beeper> 110
SubMenu <Language> 111
SubMenu <Date/Time> 112
SubMenu <PIN Code> 114
SubMenu <Cuvette-test> 116
SubMenu <Parameter import> 118
SubMenu <Parameter export> 121
SubMenu <Info> 123
Sample print-outs PT and calibration 124
7 TROUBLESHOOTING 126
Application errors 126
Cancel incubation / measurement 127
Status messages CuvCARD (in alphabetical order) 128
Error messages (in alphabetical order) 130
Errors during operation 135
Warnings 136
8 MAINTENANCE AND HYGIENE 140
Safety 140
Operating and auxiliary materials 141
Disinfectant 141
Hand protection 141
Eye protection 141
Other 141
9 TRANSPORT 142
Prepare the analyzer for packaging 142
Pack the analyzer for shipment 143
10 SERVICE INFORMATION SHEET (CUSTOMER COMPLAINT) 145
11 DECOMMISSIONING AND STORAGE 146
Content 6
User Manual DCA-1
12 DISPOSAL OF THE ANALYZER 147

13 APPENDIX 148
Technical data 148
System related 148
Electrical data 149
Environmental requirements 150
Disposables 150
Materials supplied 151
Optional equipment 151
Supplier documentation 151
Content 7
User Manual DCA-1
1 IMPORTANT INFORMATION
Definition OEM / PLD
OEM (Original Equipment Manufacturer)

LABiTec®
LAbor BioMedical Technologies GmbH
An der Strusbek 6
D 22926 Ahrensburg
Tel.: +49-4102 47950
Fax.: +49-4102 479535
Email: info@labitec.de
Website www.labitec.de
PLD (Private Label Distributor)

Dutch Diagnostics B.V.
Hekkehorst 3
7207 BS Zutphen
The Netherlands
Email: info@dutch-diagnostics.com
Website www.dutch-diagnostics.com
Liability Disclaimer
The OEM 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 the OEM without notice and without implying any
obligation or liability on the part of the company.
1 Important Information 8
User Manual DCA-1
Software Copyrights
All software used with the analyzer is the intellectual property of

the OEM. Intellectual property rights shall remain with the OEM.
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. The
OEM reserves the rights to modify the software, documentation
as well as this operator manual without prior written notice and
without prior agreement from the PLD.
Intellectual Property
DCA-1 is a product name of the PLD. All rights reserved by OEM.

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 the OEM.
Any reference to products, documentation, articles within this
publication not expressly described as property of OEM shall be
considered as intellectual property of the publishing company of
this certain product, documentation and or article.
Warranty
The OEM, the PLD or his authorised sub-distributor warrant this

analyzer 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.
The OEM, the PLD or his authorised sub-distributor further agree
to correct, either by repair, or, at its election, by replacement, any
such defect found on examination to have occurred, under normal
use and service, during one-year period, provided The OEM, the
PLD or his authorised sub-distributor is properly notified in writing
upon discovery of such defect.
User Manual DCA-1
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 channel.
✓ Defects which are caused by use of improper printer paper.
User Manual DCA-1
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
User Manual DCA-1
Problem description
Describe the problem as detailed as possible. This may clarify the
situation.
✓ Display Messages
✓ Printouts
✓ Screenshots
✓ Photos
Analytical data
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, …
User Manual DCA-1
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
Date of
Manufacturer
manufacture
Batch Code Serial Number
Do not use if
CE
packaging is
Conformity
damaged
Refer to
Operators Do Not Reuse
Manual
Caution
Protect From
Danger
Sunlight.
Warning
Traceblility
Temperature number
Limitation. according to
customer.
Humidity Important
Limitation. Information.
Electric
Shock Biological Risk.
Warning
2 Terms, abbreviations and symbols used in this manual 13

User Manual DCA-1
Symbol Meaning Symbol Meaning
Fuse This side up.
Separate
collection,
handling and
disposal for
Keep dry!
waste electrical
and electronic
equipment and
its components
Observe
Precautions for
handling
electrostatic
Do not throw sensitive devices
(ESD) / Warning
of damages by
electrostatic
discharge
In vitro
Diagnostica

User Manual DCA-1
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.

User Manual DCA-1
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
3 Safety 16
User Manual DCA-1
Duty of care of the user
This User manual describes the analyzer and is directed to all

users of the device.
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.
Intended use
WARNING
For in-vitro diagnostic (IVD) use only!
The DCA-1 (Model CD12-1-17) named hereafter as analyzer, is a

semi-automated 1-channel in-vitro diagnostic analyzer for
coagulation of blood plasma. The type of the light source is an
infrared LED.
The analyzer is capable to perform a wide range of coagulation
tests such as Prothrombin time, activated and partial Thromin
time, Fibrinogen.
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.
• Do not use sharp objects to operate the buttons of the
anaylzer.
• Protect the measuring channel from direct sunlight or other
light sources.
3 Safety 17
User Manual DCA-1
• 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 18
User Manual DCA-1
Reagents
For proper coagulation analysis we recommend to use reagents,
controls and buffers supplied by PLD.
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 - ELECTRICAL SHOCK

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 19
User Manual DCA-1
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 RISKS

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.
3 Safety 20
User Manual DCA-1
Emergency and first aid
CAUTION
In case of emergency immediately interrupt the
operation of the analyzer and pull out the external
power supply 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 21
User Manual DCA-1
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 1.25 AT
4 Installation 22
User Manual DCA-1
Component overview
✓ Thermal block +37.4°C +/- 0.4°C

✓ 4 x cuvette positions
✓ 1 position for reagent bottles (NO stirring implemented)
✓ 1 measuring channel with light protection cap
✓ Display 2 lines, 20 characters each
✓ Membrane keypad with keys (0 - 9, Mode, Enter, ESC, <,>,
Start and Reset)
✓ ChipCARD / CuvCARD reading unit
✓ Secure Digital Memory Card (SD Card)
✓ Power supply socket
✓ 1x 6-pin Mini DIN RS232-C
✓ 1x USB interface (Type B)
Software
The analyzer software is stored in a memory chip and activated

as soon as the analyzer is connected to the plug-in power supply
attached to the mains supply.
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.
4 Installation 23
User Manual DCA-1
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 16.
2. Compare the input range of the plug-in power supply with the
local mains voltage. Make sure that 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 150.
Figure 4-1 External Power supply
4 Installation 24
User Manual DCA-1
NOTICE
The analyzer is delivered with an external power
supply.
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 plug-in power supply than the
delivered has been used.
6. Connect the cable of the power supply to the analyzer and the
external power supply itself to a socket outlet without voltage
surges produced by heavy power users, e.g. lifts and
centrifuges.
7. Ensure easy accessibility of the power plug at the analyzer
rear side and/or at 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
1 USB Port B
2 Serial interface for Barcode-Scanner or external Printer
3 Power supply socket
4 SD card-Slot
4 Installation 25
User Manual DCA-1
Figure 4-2 Interfaces on the analyzer rear side
Thermal block and User interface
Figure 4-3 Thermal block (left area), User interface (right area) and
ChipCARD / CuvCARD reader slot on the right side of the
analyzer
The operation area of the analyzer consists of the heated Thermal
block with
✓ Reagent position
✓ Cuvette positions
✓ Measuring channel
… and of the User interface with
✓ Number keys
✓ Mode / Esc / Enter keys
✓ Start / Reset key
✓ Arrow keys (for navigation)
✓ Display
The function of the keys is described in the following table.
4 Installation 26
User Manual DCA-1
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. Confirm parameter change
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.
Start-key: manual start of measuring
- Start sample incubation timer
- Sample adjustment
- Manual test start
- Manual test stop
Reset key: manual stop of measurement,
Break of run, adjustment of sample
Current measurement is cancelled if keys
are pressed simultaneously. Display:
+
"break"
4 Installation 27
User Manual DCA-1
External printer
NOTE
Please read the suppliers manual carefully.
Connection to an external Printer (Port A)

For software activation of the external printer, see chapter 6.7.1,
page 103.
1 Serial interface RS-232-C) / Barcode-Scanner / external printer

(Port A)
Figure 4-4 Serial interface for an external printer
Serial interface data for external printer:

✓ 9600 baud
✓ 8 bit
✓ no parity
✓ 1 stop bit
✓ no Handshake
4 Installation 28
User Manual DCA-1
NOTE
Never operate the printer without paper!
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.
➢ Damage of the printing unit.
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
printing 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.
4 Installation 29
User Manual DCA-1
Activate and deactivate the external printer

The printer is connected to the analyzer as well as to a power
supply with a seperate cable.
The printer function in the analyzer is preset to "Off" 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 (default = 11111).
3. Press and select Port A.
4. Press to enter Port A Submenu.
5. Press and select „Printer <On>“ or „Printer <Off>“.
6. Press to confirm the selection.
4 Installation 30
User Manual DCA-1
7. Press if you want to adjust more parameters.
8. Press to switch to measuring mode.
➢ If you have changed the settings following display appears:
9. 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.
CuvCARDs - Load a cuvette balance (optional)
Without a cuvette balance no measurements can be carried out.

In this chapter it is described how to load a cuvette credit balance
of original cuvettes by means of a cuvette card, so-called
CuvCARD.
The individually loaded cuvette credit balance enables the user 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.
NOTE
Disposal of the CuvCARD may be done in the
domestic waste. Ensure in your own interest that no
balance remains on the CuvCARD.
4 Installation 31
User Manual DCA-1
➢ 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 necessary number to each analyzer.
➢ 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.
➢ Only in this state the analyzer can recognize CuvCARDs.
4 Installation 32
User Manual DCA-1
Figure 4-5 Insertion of CuvCARD with memory chip face up
2. Insert the CuvCARD face up into the reader slot (memory chip
in the direction of insertion). Leave the CuvCARD in the
reader.
➢ The following display appears.
Display Meaning
Displays the quantity of cuvette

<bookable> balance still remaining on the
CuvCARD
Quantity of cuvettes on the
<debit> CuvCARD which shall be loaded to
analyzer.
3. Press to to enter the desired quantity of cuvettes.

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>
4 Installation 33
User Manual DCA-1
➢ Entries between 100 and the maximum available quantity may

be done in steps of 10 cuvettes, for example 100, 110, 120,
…200 etc.
➢ The 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 between 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!
6. Wait until the message appears to remove the CuvCARD.
4 Installation 34
User Manual DCA-1
7. Remove the CuvCARD from the reading unit and the analyzer
automatically turns to the measuring mode “cuvette in”.
➢ 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.
As soon as the cuvette balance has been loaded, the analyzer

automatically prints the following information.
CuvCARD balance
loaded to
DCA-1 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
4 Installation 35
User Manual DCA-1
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.
➢ The operator has the possibility to store method-specific data

and parameters from the analyzer on the ChipCARD in case
they are unitentionally changed and have to be reloaded. In
this case, 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.
➢ ChipCARDs can be ordered at any time. Please contact our

sales department.
➢ For further information how to enter the menu, read chapter

6.6.1.5, page 78 and chapter 6.6.1.6, page 80.
➢ For troubleshooting see chapter 7, page 126.
4 Installation 36
User Manual DCA-1
Connection to a HOST (Port B)
For software activation of the HOST connection, see chapter

6.7.3, page 106.
To connect the analyzer to the HOST a special USB cable with
USB-A (for HOST) and USB-B (for analyzer) connection.
Figure 4-6 USB cable with USB-A (for HOST) and USB-B (for
analyzer)
Figure 4-7 USB cable connected to the analzyer via USB-B
Figure 4-8 USB cable connected to HOST via USB-A
4 Installation 37
User Manual DCA-1
Connecting an external Barcode Scanner
1 2
1 USB-B Port (PORT B)

2 Serial interface RS 232-C / external Barcode-Scanner / Printer
(PORT A)
Figure 4-9 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 Sanner see
chapter 6.7.3 SubMenu <Port B> (virtual com port via USB), page
106.
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 barcode is 5V DC
max. 150 mA.
➢ The number input of the patient-ID can either be carried out by

entering the number manually (numerical data) or with a
barcode scanner (alpha numerical).
➢ For functionality of the external BC 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 Port (1)
4 Installation 38
User Manual DCA-1
2. Connect the Barcode scanner to serial interface RS 232-C (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 , select <Port B> and set Port B to HOST.
8. Press .
9. Press .

without saving.
➢ The display shows “Patient ID” to indicate, that a number is
requested.
11. Press and manually enter the Patient-ID or scan the

barcode.
4 Installation 39
User Manual DCA-1
➢ Automatically “cuvette in” appears to indicate, that the

measuring procedure can be started.
➢ See chapter 6.4.3, page 49, to start e.g. a PT measurment.
4 Installation 40
User Manual DCA-1
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 Off
Port A Off
Port B Off
Beeper On
Language English
PIN Code 11111
5 Analyzer and Method parameters 41

User Manual DCA-1
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 1-channel), no parameters
are deposited in Memory positions 8-15
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 6.5,
page 61 and chapter 6.6, page 68.
<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
6.5, page 61 and 6.6.1.5.

User Manual DCA-1

User Manual DCA-1
6 OPERATION
Measuring principle
The analyser operates according to the opto-mechanical

measuring principle. This measuring principle is especially suited
for lipemic and/or icteric colored samples as well as reagents with
kaolin.
A light beam passes through the cuvette containing the test
plasma onto a photo detector. Any change in the intensity of the
transmitted light, that is light increase or decrease, is converted
into an electric signal. Hence, even the most unstable clot can be
detected.
The period from adding the start reagent until clot formation is
measured. It then can be converted into the appropriate units (%,
ratio, INR, mg/dl, g/l).
Once the start reagent has been added, the measuring channel is
adjusted, that is the lamp intensity automatically adjusts up or
down depending on the turbidity of the test sample. In this
process the turbidity of the sample plasma and the reagent are
adjusted.
A mixer is located in the cuvette. During the measuring process
the mixer provides homogeneity of the reagent-plasma medium.
At the same time a small whirl emerges through the mixer
movement which assures that even the smallest fibrin clot is
formed in front of the photo detector.
This stirring action combined with the optical measurement
constitutes the basic features of the "turbodensitometric
measuring principle".
6 Operation 44
User Manual DCA-1
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 6.7.7,
page 114 <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.
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 26.
Contact your local distributor with regard to
adjustment of display contrast if the display cannot
be correctly read.
• Connect the power supply plug to the analyzer and the socket,
respectively.
Following information appears on a “floating display”:

✓ Analyzer name
✓ Program version and date
✓ Name of distributing company
6 Operation 45
User Manual DCA-1
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

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 the instructions for hygiene.
6 Operation 46
User Manual DCA-1
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.
1. Press .
2. Remove the cuvette from the measuring channel and close

the light protection cap.
NOTE
Make sure that the cuvette is removed out of the
measuring channel prior to confirm the message,
otherwise the automated cuvette detection and
measuring channel adjustment may not work
properly.
3. Press any key to confirm the message
➢ The measuring channel is adjusted automatically.
4. The display shows “cuvette in” and the measurement can be

started.
6 Operation 47
User Manual DCA-1
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.
Measuring Mode (= “cuvette in”)
NOTE
Make sure the cuvette is removed from the
measuring channel prior confirm the message and
settings are correct.
• Press to switch to the measuring mode of the according

method
➢ The selected method has been initialized.
6 Operation 48
User Manual DCA-1
➢ Only in this mode measurements can be carried out.
➢ “cuvette in” requests the user to place the cuvette into the
measuring channel.
NOTE
For all tests you can do single determination
measurement, with one result. A mean value
calculation from two single values afterwards is not
supported by the software.
Measuring Mode (= “Patient ID”)

If HOST is activated in the UTILITIES menu (chapter 6.7.3, page
106) the measuring is carried out the following.
1. From STANDBY press to enter the measuring mode

(Patient ID).
2. Press .
3. Enter the patient ID manually (with number keys) or use the

external barcode scanner.
4. Press within <30 sec.
6 Operation 49
User Manual DCA-1
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:
<Read Pat-ID Time Out>
Then, the display automatically switches back to
Patient ID display.
➢ From this point (= “cuvette in”) the measurement can be

started as described in the next chapter.
When the measurement is finished (= result appears on the

display) all information is also transferred to HOST via USB-B
Port . See also chapter 4.9.1 Connecting an external Barcode
Scanner, page 38.
6 Operation 50
User Manual DCA-1
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

channel 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, place
the cuvette into the measuring channel and close the light
protection cap.
➢ The analyzer automatically recognizes the cuvette and starts

the timer for sample incubation (timer count down).
6 Operation 51
User Manual DCA-1
➢ A 5 second period of intermitting beeps indicates, that the

measurement can be startet soon.
➢ The display shows INCUBATION READY (incubat. ready) and

then AUTO ADJUST.
➢ After the sample incubation the measuring channel will be

adjusted (zero adjustment) for the measurement (adjust).
Add start reagent
➢ After the adjustment the following display appears for the PT-
Measurement and requests to add 100 µl start reagent.
5. 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.
➢ During the measurement the display shows the measuring

time until the clot is formed.
6 Operation 52
User Manual DCA-1
➢ 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 and appear on the display.
Results
Results (time in sec, Conversion to % and INR) are displayed.
➢ If a printer is connected and set to <Auto> the result is printed

automatically.
➢ If the printer is set to <On> press to print the result.
PT
Patient _ _ _ _ _
No. = 1
Channel = 1
Time = 13.7 s
% = 74.4
INR = 1.18
Figure 6-1 Example print out of PT result
➢ After the print out, “cuvette out” appears in the display.
6 Operation 53
User Manual DCA-1
• Open the light protection cap, take out the cuvette, close the
cap and press
➢ The display shows “cuvette in” again and the next

measurement can be started.
Carry out an aPTT Measurement
NOTE
(reconstitution, prewarming) we refer to the
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

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.
6 Operation 54
User Manual DCA-1
3. Pipette 50 µl of plasma sample without air bubbles into a pre-

warmed cuvette.
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 cap of the measuring channel.

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
INCUBATION READY and then AUTO ADJUST.
➢ After sample incubation the measuring channel will be

adjusted (zero adjustment) for the measurement.
Add start reagent
After the adjustment the following display appears:
6 Operation 55
User Manual DCA-1
7. Pipette 50 µl of prewarmed start reagent (CaCl2) vertically

through the hole of the light protection cap of the measuring
channel into the sample cuvette.
➢ During measurement the display shows the measuring time

until the clot is formed.


detected an acoustic signal indicates that the measuring time
is reached without clotting detection.

converted automatically.
Results
Results (time; Ratio) are displayed.

out automatically.
6 Operation 56
User Manual DCA-1
aPTT
Patient _ _ _ _
No. = 2
Channel = 1
Time = 31.5 s
Ratio = 1.13
Figure 6-2 Example print out of aPTT result
cap and press .

6 Operation 57
User Manual DCA-1
Carry out a Fibrinogen Measurement g/l
NOTE
(reconstitution, prewarming) we refer to the
Sample incubation

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 prewarmed cuvette 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 timer for sample incubation (60 sec. timer count down).
6 Operation 58
User Manual DCA-1
➢ A 5 seconds period of intermitting beeps indicates the

remaining incubation time and the display shows
INCUBATION READY and then AUTO ADJUST.
➢ After sample incubation the measuring channel will be

adjusted (zero adjustment) for the measurement.
Add start reagent
After the adjustment the following display appears:
7. Pipette 50 µl start reagent vertically through the hole of the

light protection cap of the measuring channel into the sample
cuvette.
➢ During measurement the display shows the measuring time.


detected an acoustic signal indicates that the maximum
measuring time is reached without clotting detection.

converted automatically.
6 Operation 59
User Manual DCA-1
Results
Results (time; g/l) are displayed.

automatically.
Fib. g/l
Patient _ _ _ _ _
No. = 3
Channel = 1
Time = 5.7 s
g/l = 3.87
Figure 6-3 Example print out of Fibrinogen result
cap and press .

6 Operation 60
User Manual DCA-1
Parameter configuration - Access WITHOUT PIN
The following parameters can be accessed from the measuring

mode (cuvette in) directly without entering the PIN Code.
✓ 1st conversion with calibration points
✓ ISI
✓ Start Reagent Lot Number
✓ MNP value (depending on method)
✓ 2nd conversion (MNP value)
This chapter is 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 42.
➢ 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.
6 Operation 61
User Manual DCA-1
➢ 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 defining 4 points (100%, 50%, 25%,
12.5%).
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 "cuvette 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 Operation 62
User Manual DCA-1
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

(50%, 25%, 12,5%)
9. Press to confirm and switch to the ISI.

10. Enter the ISI-value of the respective reagent as indicated in
the according reagent leaflet in the table of values with
number keys and to set the decimal point.
11. Press to confirm the entry.
12. Press to confirm and set the Lot Number with number
keys of the according Start reagent.
13. Press
6 Operation 63
User Manual DCA-1

without saving.
➢ The analyzer switches automatically back to the measuring

mode.
Set calibration curve points for Fibrinogen

1. Select required Method in STANDBY, here Fibrinogen g/l.
3. Press from " cuvette 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. 6 g/l
and to set the decimal point.
5. Press to confirm and enter the next line.
6 Operation 64
User Manual DCA-1
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.
8. Press to confirm and switch to set Lot.No. of the

according Start reagent leaflet.
9. Use number keys to set numbers, press to
switch to the next entry position, and press or to

enter characters or decimals).
10. Then press .

without saving.

mode.
6 Operation 65
User Manual DCA-1
Set MNP value
NOTE
MNP = Mean of Normal Plasma
1. Select required method in STANDBY, here aPTT.
3. Press from " cuvette in" directly without entering the

PIN Code.
4. Press and set the MNP value with number keys
and to set the decimal point.
5. Press to confirm and switch to set Lot.No. of the

according Start reagent.
6. Use number keys to set numbers, press or
. to enter characters or decimals and press to

switch to the next entry position and continue until the
following message appears.
6 Operation 66
User Manual DCA-1
➢ Press to save parameters or to leave the menu

without saving.

mode (cuvette in).
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.
6 Operation 67
User Manual DCA-1
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 <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.

4. Enter the PIN Code (Default no. 11111) to access the method
parameter menu. See also chapter 6.7.7 SubMenu <PIN
Code>, page 114.
If the wrong number was entered STANDBY will be displayed

again. As soon as the correct number has been entered, access
to PT Method parameter settings is possible.
5. Press to enter the respective menu and its submenus.
6 Operation 68
User Manual DCA-1
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 Exchange method memory
method> positions
<Read from Read a method from a ChipCARD
ChipCARD> to the analyzer
<Write to Safe a method to a ChipCARD
ChipCARD>
6.6.1.1 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.
6 Operation 69
User Manual DCA-1
1. Select the necessary method, press and enter the PIN
with 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.
6 Operation 70
User Manual DCA-1
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 Operation 71
User Manual DCA-1
6.6.1.2 Load default
Some method memory positions of the analyzer have been preset

by the manufacturer. In Table 5-1, page 42, 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>
6. Press or to select the desired method, here

<1 PT>.
The following display appears:
6 Operation 72
User Manual DCA-1
Automatically the next display will be displayed.
8. Press to overwrite the actual method or to leave

the menu without overwriting the parameters.
➢ 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 appears:
➢ 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.
6 Operation 73
User Manual DCA-1
6.6.1.3 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>.

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>.

appears:
6 Operation 74
User Manual DCA-1
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.

appears:


6 Operation 75
User Manual DCA-1
6.6.1.4 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>.

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

submenu <Exchange method>.

appears:
5. Press or to select the desired method in this
example e.g <1 PT> and then press to confirm and the
next display appears:
6. Press to exchange or to keep the settings.
6 Operation 76
User Manual DCA-1
➢ When exchanging, all parameters will be exchanged.

appears:


6 Operation 77
User Manual DCA-1
6.6.1.5 Read from ChipCARD
Background information for the ChipCARD in general is given in

chapter 4.8 ChipCARDs – Store or load methods, page 36.
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 and select <General> , press .
4. Press or and select <Read from ChipCARD> with
5. Insert the ChipCARD into the reader slot with the memory chip
facing up. Leave the ChipCARD in the reader, see Figure 4-5,
page 33 for correct insertion and chapter 4.8 ChipCARDs –
Store or load methods, page 36 for more information.
➢ If no ChipCARD is inserted or 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.
6 Operation 78
User Manual DCA-1
9. Press or to select between the following options:
10. Select <Yes> to start the loading process.
➢ 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. This is an example name of the method.
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:
6 Operation 79
User Manual DCA-1
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:

without saving.
6.6.1.6 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.
6 Operation 80
User Manual DCA-1
3. Press or and select <General> , press .
4. Press or and select <Write to ChipCARD> with
5. Insert the ChipCARD into the reader slot with the memory chip
facing up. Leave the ChipCARD in the reader, see Figure 4-5,
page 33 for correct insertion and chapter 4.8 ChipCARDs –
Store or load methods, page 36 for more information.
7. Press or to select among the following options:
8. Select <Yes> and and press to confirm.
then
➢ With “Writing parameters to ChipCARD “ the parameters on

the ChipCARD will be replaced by the new parameters coming
from the analyzer.
6 Operation 81
User Manual DCA-1
9. Remove the ChipCARD from the ChipCARD reader.
Automatically, the next menu appears:
10. Press until “checking parameters please wait" appears,

then

without saving the changes.
12. Automatically STANDBY or the measuring mode is reached.
6 Operation 82
User Manual DCA-1
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 6.5, Parameter
configuration - Access WITHOUT PIN, page 61.
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 Linear / Reciprocal / Logarithmic
interpolation>
<None> No conversion
6 Operation 83
User Manual DCA-1
1. Set the analyzer to STANDBY <1 PT>.
2. Press enter the PIN Code (factory default: 11111).
➢ See also chapter 6.7.7 SubMenu <PIN Code>, page 114.
➢ If the number was incorrect STANDBY display appears again.
➢ 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
6 Operation 84
User Manual DCA-1
6.6.2.1 <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.
6.6.2.2 Set <Reference curve>
1. Press the following display appears:
2. Press or to choose between falling and rising.
NOTE
Reference curves must be entered as follows:
Rising curves (inhibitors) start with the lowest value.
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!
6 Operation 85
User Manual DCA-1
6.6.2.3 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.
6.6.2.4 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.
6 Operation 86
User Manual DCA-1
6.6.2.5 Set Min/Max value (Conversion limits)
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.
6.6.2.6 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:
6 Operation 87
User Manual DCA-1
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%.
5. Press to confirm the entry, the field for the next point on
the reference curve appears automatically.
1. Verify or adjust the second calibration point as previously

described.
2. Proceed as described above to set the remaining calibration
points.
6 Operation 88
User Manual DCA-1
6.6.2.7 Set <Time Interpolation>
As soon as the last point on the reference curve has been

confirmed the following display will appear:
In the following display you can select Time interpolation modes

of the time axis the following options can be selected:
<linear>, <reciprocal>, <logarithmic>.
• Press or to select e.g. <linear> and press to

confirm.
6.6.2.8 Set <Value Interpolation>
In the following display you can select Value interpolation modes

for the activity/concentration: <linear>, <reciprocal>,
<logarithmic>.
• Press or to select e.g. <reciprocal> and press
to confirm.
• Press to access measuring or to set or verify

more parameters.
6 Operation 89
User Manual DCA-1
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 6.5, page 61.
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.
6 Operation 90
User Manual DCA-1
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 MNP (only if <1st
conversion> is set to <None>. e.g.
Mean value of the normal plasma
aPTT range.
<None> No conversion
• Press to access the submenu <2nd conversion>.
6 Operation 91
User Manual DCA-1
6.6.3.1 Select <INR> and set the ISI value
1. Press and the following display appears:
2. Press to confirm and enter the next display.
3. Use number keys to enter the ISI-value and

to set the decimal.
5. Press to access measuring or to set or verify

more parameters.
6 Operation 92
User Manual DCA-1
6.6.3.2 Select <RATIO> and set MNP
If for <1st conversion> <none> is selected, the following display

appears to enter the MNP time value.
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.
6.6.3.3 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.
6 Operation 93
User Manual DCA-1
Menu <Measurement>
CAUTION
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 6-3 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. for print-outs
<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
6 Operation 94
User Manual DCA-1
6.6.4.1 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.

3. Enter the reagent Lot Number manually the same way.
NOTE
Alternatively, if a barcode scanner is connected:
• Scan the barcode label of the reagent vial (a
maximum 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.
6 Operation 95
User Manual DCA-1
6.6.4.2 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.
See according reagent leaflet for correct incubation
times.
Example for PT-Method Incubation time of Start reagent.

NOTE: 0 s = no incubation, Max.: 600 s.
1. Enter the method-dependend 1st sample incubation time for
1st = 0 s and 2nd =xxx s with the number keys .
6.6.4.3 Set Start number for Print out
The next display appears.
NOTE: Max.: 3-digits (1-999).

• Enter the start number for print out by using the number keys
• Press to confirm the entry.
6 Operation 96
User Manual DCA-1
6.6.4.4 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 41, Table 5-1.
Before modification consult your local
distributor.
Example for Method Fibrinogen mg/dl
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 500 rpm (rpm1)
and reaches 200 rpm (rpm2) after 40 seconds.
Figure 6-4 Exemplary function of mixer speed reduction
6 Operation 97
User Manual DCA-1
6.6.4.5 Set <min value>
➢ Here you can enter the (individual evaluated) mininum value

(as digits) for the light that has to pass to the sample.
➢ In case the sample is very turbid due to e.g. lipemic samples

the passing light goes below this minimum value.
➢ As a result a "Break Dark" message appears on the display.
➢ ‘0’ means off, the detection of a mininum value is deactivated.
➢ The curser is blinking and the value can be entered with

number keys.
• Press to continue (to the next display).
6.6.4.6 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.
6 Operation 98
User Manual DCA-1
2. Press to access measuring or to set or verify

more parameters.
6.6.4.7 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.

➢ You jump automatically to the “meas. time” display.
6.6.4.8 Set measuring time
Here the total measuring time, depending on the test method

(here aPTT), can be set.
6 Operation 99
User Manual DCA-1
1. Enter the measuring time with number keys or confirm and

proceed.

3. Automatically the next display appears.
4. Press until “checking parameters please wait" appears,

then:

without saving the changes.
➢ Automatically STANDBY or the measuring mode is reached.
6 Operation 100
User Manual DCA-1
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 6-4 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 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
<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.
< Param.im/export > Service: Load parameter from a SD-
Card, Save parameter onto SD-Card
Info Shows name of analyzer, software
version with corresponding date.
6 Operation 101
User Manual DCA-1
2. In STANDBY 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.
➢ 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 (cuvette in) or
press to set or verify more parameters.
6 Operation 102
User Manual DCA-1
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 external printer.
Table 6-5 Printer selections
Selection Meaning
<On>
Printer is activated, Press for print-
out.
<Auto> Print of results automatically, as soon as the
test result is available.
<Parameter Print of Method- and global analyzer
protocol> parameter
<Actual Print of method parameter of a selected
Method> method
<All Print of all analyzer- and method parameter
Parameter>
<Global> Print of global analyzer parameter
<Off> Printer is deactivated
Printout e.g. <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>.
6 Operation 103
User Manual DCA-1
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 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.
6 Operation 104
User Manual DCA-1
SubMenu <Port A>

The analyzer model is equipped with a 6-pin RS 232-C interface
at the backside of the analyzer (= Port A). This interface can be
used for external data communication, to connect an external
printer or barcode scanner.
Table 6-6 Port A - Selections
Selection Meaning
<Off> RS 232-C interface (Port A) is deactivated
<ext. printer> Serial output of data to external printer

<Port A>.
2. Press to enter the Port A submenus.
3. Press or to select among following options:
4. Press to confirm and activate respective option.
5. Press to return to the measuring mode or press

to set or verify more parameters.
6 Operation 105
User Manual DCA-1
SubMenu <Port B> (virtual com port via USB)

To link the analyzer to a HOST see chapter 4.9, page 37 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 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 (see also chapter 4.9
Connection to a HOST (Port B), page 37.
➢ The USB interface can only be used to connect the analyzer

to a HOST. It is not possible to connect an external printer.
Table 6-7 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 to the
RS232 interface.
<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).
6 Operation 106
User Manual DCA-1
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.
➢ 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 HOST start

the user software.
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).
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>DCA-1; G1560001; dd:mm:yyyy, hh:mm:ss; 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>DCA-1; G1560001; dd:mm:yyyy, hh:mm:ss; 1895;
aPTT; 1; 88,2;s; void;void; 3,15;Ratio; void;void; OK;
D334;<CR><LF>.
6 Operation 107
User Manual DCA-1
✓ HOST output Flags

o M = Mixer Motor (measurement stops, critical error)
o T = Temp (warning)
o 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:

<Port B>.
2. Press to Port B submenus.
3. Press or to select among following options:
4. In this case select HOST and press to confirm.

➢ Automatically the next display appears:
5. Press to set more parameters or to return to

STANDBY and measuring mode.
6 Operation 108
User Manual DCA-1
➢ The analyzer checks the parameters.
➢ If parameters had been changed and saved, the following

message appears:
➢ If parameters are unchanged the following message appears:
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.
6 Operation 109
User Manual DCA-1
SubMenu <Beeper>
The beeper acoustically confirms:

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

<Beeper>
2. Press to enter the Beeper submenus.
Table 6-8 Beeper selctions
Selection Meaning
Activates the beeper.

<On>
Each action is confirmed by the beeper
<Off> Deactivates the beeper.
<Click> Only keystrokes will be confirmed by the beeper
6 Operation 110
User Manual DCA-1
SubMenu <Language>
This menu allows you to select different analyzer software

languages.
The Default language is English.
Table 6-9 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

<language>.
2. Press
3. Press or to select the required language.
6 Operation 111
User Manual DCA-1
4. Press to confirm the selected language.
5. Press to save the selection or to return without

changes.
After that:
6. Press to return to the measuring mode.
7. Press to set more parameters.
SubMenu <Date/Time>
In this menu you can set the actual date and time of the analyzer.

<Date/Time>
2. Press
6 Operation 112
User Manual DCA-1
➢ 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 .
9. Press to save or to return to the measuring

mode.
➢ The analyzer switches to the measuring mode of the last
method set.
6 Operation 113
User Manual DCA-1
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.
✓ Have full access to all method parameters.
✓ Set / adjust the conversion parameter and reagent Lot
Number.
✓ 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:
6 Operation 114
User Manual DCA-1
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.
➢ If changes are saved a print out will follow if a printer is
connected and the 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.
6 Operation 115
User Manual DCA-1
SubMenu <Cuvette-test>
This menu checks the function of the automatic cuvette
recognition.
➢ The thermal block has to be warmed up to operating
temperature.

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

appears:
3. Insert a cuvette into the measuring channel

➢ The transmission threshold value is used to decide whether a
cuvette is inserted or the light path is free of a cuvette.
➢ If a cuvette is inserted into the measuring channel, the display

shows “cuvette” 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 cuvette from the measuring channel.
6 Operation 116
User Manual DCA-1
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 info appears:
• Wait until the temperature of 37.4°C is reached and the

adjustment of the measuring channel is finished. Then carry
out the step again.
6 Operation 117
User Manual DCA-1
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
to the analyzer.
To execute this function a fat32 formatted SD-Card must be
inserted into the analyzer SD-Card slot.
Formatting of 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
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.
IF the SD-Card is protected the analyzer shows a
P-FLAG. In this case remove the SD-Card, unlock it
and insert it again
6 Operation 118
User Manual DCA-1
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.

<Param. im/export>.
4. Press .
5. Select < Import <-SD-Card>.
6. Press .
➢ The parameter import starts automatically with according

message.
➢ 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.
6 Operation 119
User Manual DCA-1
➢ If parameters are different to the previous ones the display

shows.

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.
6 Operation 120
User Manual DCA-1
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.
If the SD-Card is protected the analyzer shows a P-
FLAG. In this case remove the SD-Card, unlock it
and insert it again
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.

<Param. im/export>
4. Press .
5. Select < Export - > SD-Card>.
6 Operation 121
User Manual DCA-1
6. Press .
➢ The parameter export starts automatically with according

message.
➢ 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.
If parameters are different to the previous ones the display shows.

measurments.
6 Operation 122
User Manual DCA-1
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.
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
• Press or to switch between lines.
6 Operation 123
User Manual DCA-1
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 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>.
6 Operation 124
User Manual DCA-1
Print-out of method PT (Example):

Conversions via a 4-point calibration curve in % and INR.
- method store 1 -
`PT´
Date dd.mm.yyyy
Meas time = 420 s
Gain_idx = 0
Cuv in ON Automated cuvette
Reagens_sens ON detection
Start Reagent:
Lot = 1 Reagent-Lot. No.
Volume = 100 ul Reagent Start Volume
incubat. = 60 s Incubation time
1st convers 1. conversion, calib.
INTERPOLAT. 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
___________
dd:mm:yyyy, Date, Time
hh:mm:ss
No. = 1 Print.-out no.
Channel = 1 Channel No. 1
Time = 12.0s Measuring time
% = 90.4 Conversion to PT %
INR = 1.06 Conversion to INR
6 Operation 125
User Manual DCA-1
7 TROUBLESHOOTING
Faults may caused by actions during use and/or by the system

itself. The analyzer displays error messages and warnings in the
display.If an external printer is attached and activated the
information are printed out.
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.
➢ The wrong pipette tips were used.
➢ The pipetted volume is incorrect (e.g. variable Pipets).
➢ The pipetting process was too slow or the pipetting angle

incorrect.
➢ The temperature of the start reagent deviates from 37,4°C.
➢ Cuvettes are not prewarmed / too cold for plausible

measuring.
➢ The sample, control or reagent 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 mixed properly.
7 Troubleshooting 126
User Manual DCA-1
➢ No or an incorrect calibration curve is available.
➢ Errors appeared during the sample collection or centrifugation.
➢ Method parameters relevant for measuring are incorrect.
Should any of these errors occur and they are recognized in time,
solve them immediately.
Cancel incubation / measurement
If you realize wrong handling and want to interrupt the

measurement stop the measurement with the following key
combination.
• Press and at the same time to stop the

measuring process on the respective channel.
User Manual DCA-1
Status messages CuvCARD (in alphabetical order)
Status message
Cause Action
(display/print)
Balance and The cuvette Insert new

reserve fully balance and CuvCARD and
used. reserve quantity is load new balance
now fully used, no to analyzer, once
further the cuvette
measurement balance and
possible reserve quantity
is fully used.
Balance fully The cuvette Insert new
used! balance on the CuvCARD and
analyzer is now load new balance
fully used, no to analyzer, once
further the cuvette
measurements balance is fully
possible. used. Make sure
always having
enough cuvettes
on stock.
CuvCARD Cuvette balance Use new
devalued! on CuvCARD is CuvCARD
fully used, delivered with
CuvCARD is cuvettes boxes.
empty! Make sure
enough cuvettes
are available.
Only xx Message shows Perform
measurements the remaining remaining number
remaining. quantity of of measurements,
measurements left when used, insert
to utilize. new CuvCARD
and load new
balance.
Make sure
enough cuvettes
are available.
User Manual DCA-1
Only xx reserve Message provides Insert new

measurements information, that CuvCARD and
remain possible. only a certain load new balance
reserve quantity is to analyzer, once
left to utilize. the reserve
quantity is fully
used.
Make sure
enough cuvettes
are available.
Only a few Message provides Insert new
measurements information, that CuvCARD and
remain possible. only a small load new balance
reserve quantity is to analyzer, once
left to perform. the cuvette
balance is fully
used.
Make sure
enough cuvettes
are available.
Please order Note; balance and Timely order new
new cuvettes. reserve will run cuvettes to be
short soon. able continuing
measurements.
User Manual DCA-1
Error messages (in alphabetical order)
Error message
Cause Action
(Display)
break time Possibly no Optical test for

clotting; clots; repeat test
The maximum
measuring time has
been exceeded.
break top Exceeded Repeat test
measuring range
(too high) possibly
caused by air
bubbles
break bott(om) Exceeded Repeat test
measuring range
(too low)
preparation
becomes turbid
break moto(r) Mixer motor error Contact
occurred technical service
break nois(e) Signal too noisy Check for air
after sample bubbles or other
adjustment particles, e.g.
mixer fallen out
of the cuvette
into the channel.
break drft (drift) Measured curve Check sample
drifted after reagent for air bubbles
has been added or or if start pipette
start pipette error. is activated in
soft-ware but not
linked to
analyzer
break adj(ust) Light value is too Check sample
low during and try again
adjustment phase
(too little light
User Manual DCA-1
Error message
Cause Action
(Display)
passes the
channel)
break Measurement Intentionally
cancelled with done by user!
and
Bright value Channel is not free, Remove the
failed e.g. remaining cuvette
cuvette, dust or Clean the
other debris channel
disturbs the light
path Then press
ENTER to retry
or ESC to go to
the next channel
If necessary call
the technical
service.
Channel A measuring Load new
locked! channel is locked cuvette balance
due to no to analyzer.
remaining cuvette Switch OFF the
balance available. analyzer and
Error during ON again to
adjustment repeat the
adjustment.
CuvCard or Parameter Contact
ChipCARD checksum on technical service
Checksum error! inserted card type
is incorrect
CuvCard or Inserted card type Re-insert card
ChipCARD may be defect. and repeat
Read error! process,
otherwise
contact technical
service
User Manual DCA-1
Error message
Cause Action
(Display)
illegal card! Utilized CuvCARD Try another

please remove it. may not carry CuvCARD or
cuvette credit or is contact technical
a wrong card. service.
Invalid customer Customer ID Contact
ID number on distributor
No booking done! CuvCARD does not
correspond to
cuvette type used.
Empty/invalid Inserted Repeat process
card ChipCARD could or use other
not be read due to ChipCARD.
possible incorrect Contact
or no data being on distributor.
the card.
card write error. An error occurred Contact
NOT booked! while writing data technical service
to card.
Wrong cuvette Cuvette type on Contact
type cuvette card does distributor
No booking done! not correspond to
cuvette type on
analyzer.
Warning: Read Error Insert the
ChipCARD Error! ChipCARD with
ChipCARD is the correct
inserted upside direction
down Insert correct
Wrong blank blanko
ChipCARD has ChipCARD
been inserted Insert correct
Wrong Method Method
ChipCARD has ChipCARD
been inserted
Invalid version of
ChipCARD has
been inserted
User Manual DCA-1
Error message
Cause Action
(Display)
WARNING: A card still remains Remove card

Please remove in the card reading and press
ChipCARD! unit ENTER to
continue
WARNING: Wrong ChipCARD Use ChipCARD
incompatible with incompatible with method
method method data was data compatible
inserted into the to the analyzer
analyzer. software.
SD-CARD is The SD-Card is Unlock the write-
write-protected locked protection of the
SC-Card
CD12 Inserted SD-Card Remove the

BOOTLOADER is locked after power supply
V1.0 connecting the cable, then
analyzer to the remove the SD-
power = starting. Card, unlock the
SD-Card, insert
the SD-Card
and attach the
power supply
cable to start the
analyzer again.
Invalid method Method parameters Check method
param entered are parameters
incorrect.
New name Method name was Enter method
cancelled entered incorrectly. name again.
No card! There is no Insert correct
ChipCARD or Card to card
CuvCARD inserted reader.
in the card reader.
No SD-Card SD-card could not Check SD-Card,
detected. be read. perhaps use
another card
instead.
User Manual DCA-1
Error message
Cause Action
(Display)
No SD-Card While trying to Insert SD-Card

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

analyzer failure. function of the
Loose power power supply.
cable. If the power
Mains power supply is ok but
failure. the analyzer does
not work, contact
your local
distributor or the
technical service.
Analyzer fails Power supply Check the
during operation failure. function of the
Loose power power supply.
cable? If the power
Mains power supply is ok but
failure. the analyzer does
not work, contact
your local
distributor or the
technical service
User Manual DCA-1
of the
manufacturer.
Measuring cells Additional Remove liquid
contaminated pipetting of with pipette,
with liquids plasma or reagent clean with
into the measuring appropriate
cell without absorbent cloth
cuvette. and disinfectant.
Warnings
Warning Meaning Action
Cool down This message will Might occur due to

appear when it is direct sunlight, place
determined while the analyzer to
no measurements another place with
are running that the lower light input.
thermal block is too Contact technical
warm. No other service.
measurements can
be started during
cool down.
WARN: If during a Might occur due to
Temp. measurement the direct sunlight.
instabile temperature of the Place the analyzer to
(TEMP thermal block another place with
WARN) deviates lower light input.
significantly from
the set value, the Contact technical
measurement is not service
cancelled. Instead
this warning
appears in the
display and is also
printed out via the
active printer.
ERR over This message Check conversion
(calculation appears if a If the err over
overflow) calculated message is displayed
measuring value check the
cannot be
User Manual DCA-1

(in display displayed parameterization of
and printout) (calculation the calibration curve
overflow) because parameters
of size overflow.
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 Check adjustments
calculation detetced on Time Interpolation
a negative value. and Value
interpolation.
Repeat
measurement and
check reference
curve.
ERR no clot No clotting detected Check sample and
during method parameter
measurement. settings, repeat
measurement.
ERR log0 Measurement Check adjustments
calculation detetced on Time Interpolation
a negative value. and Value
interpolation
Repeat
measurement and
User Manual DCA-1

check reference
curve.
ERR bright- An error has been Remove all cuvettes
calib ch%u: detected during from measuring
Bright calib bright calibration. channel and repeat
failed! adjustment. Might
occur due to direct
sunlight, place the
analyzer to another
place with lower light
input.
Close light protection
cap.
Contact technical
service if problem
persists.
ERR dark- An error has been Remove all cuvettes
calib ch%u: detected during from measuring
Dark calib dark calibration. channel and repeat
failed! adjustment. Might
occur due to direct
sunlight, place the
analyzer to another
place with lower light
input.
Close light protection
cap.
Contact technical
service is problem
persists.
min-value During the input of Check the Range for
reached the calibration the calibration and
- no more curve, the range of enter the values
points values (%, g/l, again.
mg/dl) is limited for
or each method due to
max-value factory settings. In
reached addition the points
must increase or
User Manual DCA-1

- no more decrease
points 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.
User Manual DCA-1
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 cap is considered to be
potentially contaminated. Therefore, the
manufacturer recommends to replace it once a
year. Contact your local distributor for further
information.
8 Maintenance and Hygiene 140

User Manual DCA-1
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.
Operating and auxiliary 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.
Eye protection
✓ Safety eye glasses.
➢ Splashes are likely to occur, there is a risk of infection.
Other
✓ Lint-free cloth.
8 Maintenance and Hygiene 141

User Manual DCA-1
9 TRANSPORT
If you should have thrown away the packaging material, please

contact the manufacturer, see chapter 1.1, page 8.
See also chapter 4.3 for further information.
Prepare the analyzer for packaging
NOTE
Please clean and disinfect the analyzer at first.
Take care when moving the analyzer.
Secure the analyzer 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).
NOTE
Do not leave any
loose parts inside the
analyzer!
9 Transport 142
User Manual DCA-1
Pack the analyzer for shipment
1. Fold the flat card box,

insert the analyzer and
secure it as shown in
the following pictures.
9 Transport 143
User Manual DCA-1
2. Open the box

3. Insert film-card
secured analyzer onto
the botton of the box.
4. Take power supply

plug and the
accessory box and put
them into the box.
5. Turn down the side
flaps.
6. Close the cover of the

box and seal it with
packaging tape.
9 Transport 144
User Manual DCA-1
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.
10 Service Information Sheet (Customer Complaint) 145

User Manual DCA-1
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 the external power supply 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 channel as
dust protection.
8. Put the analyzer into a film bag.
9. Put the external power supply and power
cable into a film bag.
10. Store the analyzer and additional items at a
safe, dry place.
11 Decommissioning and storage 146

User Manual DCA-1
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 from the socket and remove the
power supply cable from the analyzer.
2. Remove all loose items, e.g. cuvettes or vials from the
analyzer.
3. Clean / disinfect the analyzer properly with Ethanol (96%,
denatured).
4. Let the analyzer dry for a certain time to get rid of any possible
remaining liquid.
5. Put the analyzer into a film bag.
6. Put the power supply plug and power supply cable into a film
bag.
7. Prepare the analyzer for transport as described in Chapter 9
Transport, page 142.
Do not dismount and recylcle the analyzer by yourself.
➢ All parts parts must be disposed of in accordance with
national directives for disposal
➢ For disposal send the analyzer to a registered waste

disposal authority.
12 Disposal of the Analyzer 147

User Manual DCA-1
13 APPENDIX
Technical data
System related
Characteristics Description
Type of analyzer Semi-automated 1-channel in-vitro

diagnostic analyzer for coagulation
Application Clotting tests
Operation Described in this User Manual
Measuring principle Turbodensitometric
Sensitivity ~ 1 g/l Fibrinogen
Test throughput ~30/h PT, ~15/h aPTT
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, in sec
Intr. Factor, in %, Extr. Factor, in %
Light source LED approx. 875 nm
Display Liquid crystal display, 2 lines with
20 characters each
Thermal block Temperature controlled at 37.4°C
+/- 0.4°C
Measuring channel 1
13 Appendix 148
User Manual DCA-1
Light protection caps: 1 (designed for yellow pipette tips

by Eppendorf)
Reagent positions 1 á 22 mm diameter
Cuvette positions 4
Measuring time max. 420 sec
Interfaces RS232-C, USB-B, SD-Card, Card
reader
System time Real time clock for time and date
Dimensions Approx. 160 x 210 x 80 mm
(LxWxH)
Weight Approx. 0.80 kg
Electrical data
External power supply

Specification
characteristics
Input voltage 100 – 240 VAC

Rated input current Approx. 0.4 A
Rated input frequency 50-60 Hz +/- 3Hz
Output voltage +12 VDC
Output current Max. 1.25 A
Power consumption Max. 15 VA
Analyzer characteristics Specification
Input voltage 12 VDC

Max. input current Max 0.8 A
Overvoltage category I
13 Appendix 149
User Manual DCA-1
Pollution degree 2
Means of protection Class III
Lithium battery type Li-Mn +3V
CR 2430
Environmental requirements
Parameter Specification
Installation site Inner rooms only, dry environment

Altitude  2.000 meters
Mains voltage
Max.  10% of rated voltage
fluctuation
Temperature During operation; +15°C - +30°C
During transport and storage; +2°C -
+50°C
Humidity 10% - < 85%, non-condensing
Disposables
Type Quantity Description
Cuvettes 5 x 100 Micro Cuvettes / Dispo-

System with Mixer
1,0x4,0 mm
1x CuvCARD
1 x 500 Micro Cuvettes / Mixer 1,0
x 4,0 mm in plastic bag
1x CuvCARD
13 Appendix 150
User Manual DCA-1
Materials supplied
Quantity Description
1x DCA-1
1x 10 single cuvettes with mixer in plastic bag
1x User manual on USB stick
1x External power supply.
Optional equipment
✓ Barcode scanner
✓ External printer
✓ USB driver (if not already available at HOST)
✓ Cable for printer and scanner
Supplier documentation
✓ Barcode scanner instruction

✓ External printer instruction
✓ USB driver information
13 Appendix 151

User Manual Dca-1

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01.00 V1.0, Feb. Initial

01.01 V1.0, Feb.

01.02 V1.0, Feb. Minor

6.6.1.2 Load default 72

SubMenu <Port A> 105

12 DISPOSAL OF THE ANALYZER 147

Definition OEM / PLD

OEM (Original Equipment Manufacturer)

PLD (Private Label Distributor)

The OEM makes no express or implied warranty regarding this

All software used with the analyzer is the intellectual property of

DCA-1 is a product name of the PLD. All rights reserved by OEM.

The OEM, the PLD or his authorised sub-distributor warrant this

Exclusions of manufacturer’s warranty

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

Guidelines for getting service assistance

2 TERMS, ABBREVIATIONS AND SYMBOLS USED IN

Symbol Meaning Symbol Meaning

Batch Code Serial Number

2 Terms, abbreviations and symbols used in this manual 13

Symbol Meaning Symbol Meaning

Fuse This side up.

2 Terms, abbreviations and symbols used in this manual 14

Table 2-2 Explanations of styles used in this manual

● Instructions that have to be followed

Explanations to the given context

Things, that are required, have to be checked or

Steps that have to be carried out in the given order.

2 Terms, abbreviations and symbols used in this manual 15

This analyzer conforms with the European Directives for in vitro

Table 3-1 Explanation of safety symbols and signal words

Symbol Signal Meaning

DANGER Indicates a direct hazard with high

WARNING Indicates a possible hazard with

CAUTION Indicates a hazardous situation,

NOTICE Indicates a Damage Message only

NOTE Indicates an important note in the

Duty of care of the user

This User manual describes the analyzer and is directed to all

The DCA-1 (Model CD12-1-17) named hereafter as analyzer, is a

• Only use pipettes which are being validated in regular

DANGER - ELECTRICAL SHOCK

WARNING - MECHANICAL SAFETY

Reasonable foreseeable and remaining risks

WARNING – BIOLOGICAL RISKS

WARNING - LASER LIGHT

Emergency and first aid

Relevant actions to rescue personnell are given in the operational

There are no special measurements necessary for fire fighting.

Name Plate (Serial no.)

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

Manufacturer according to IVD

Traceblility number according to customer

Serial number of analyzer

Refers to the User manual with further information

Separate collection, handling and disposal for

Fuse characteristic 1.25 AT

✓ Thermal block +37.4°C +/- 0.4°C

The analyzer software is stored in a memory chip and activated

Mounting and connecting the analyzer

• Upon receipt remove the analyzer from its packaging check

Proceed as follows to install the analyzer: