User Manual

DIAcheck Series
C1 / C2 / C4

For In-Vitro Diagnostic use

Instrumentation and reagents for human coagulation and hemostasis

Copyright © 2020, Dialab GmbH, Austria
User Manual Revision 7
Firmware V01.03.50
Issue Aug-2020
Document No: 26 900 02
 Dialab GmbH

Updates
User Manual Software
Version Version
1 01.02.42 (first release)
2 01.02.43
3 (minor correction on OPM) 01.02.43
4 01.02.44 / 45 / 46
4b 01.02.46 (add new pictures)
5 01.02.47 and 1.02.48
6 01.03.49
7 01.03.50

Copyright Copyright © 2020 by Dialab GmbH; Neither the User Manual nor
any part thereof may be copied, digitally processed or otherwise
transferred without written permission from Dialab GmbH. The
software for Dialab GmbH products is the intellectual property of
Dialab GmbH, which company retains all rights to usage of the
software. The purchaser of a DIAcheck series acquires rights of use
for this software

Trademarks Other product names used in this User Manual are trademarks of
the respective companies.

Manufacturer Instrument is produced by

Dialab GmbH
Hondastrasse OBJ M55, IZ NOE SUED
A-2351 Wr. Neudorf
Austria

Phone: +43 (0)2236 660910-0

Fax: +43 (0)2236 660910-30
Email: office@dialab.at
Internet: www.dialab.at

Warranty The DIAcheck series is warranted for a period of one year after
delivery or first installation. It covers any defects in material,
functionality or workmanship. The first installation must be
registered online to www.dialab-reg.com (see chapter
“Registration”) or by scanning the attached QR-Code on the
System-ID-Card.

The warranty expires in case of failures caused by

 Accidident, neglect maintenance & serivce, abuse or misuse.
 Using unauthorized reagents, consumables or spare parts
 Unauthorized service. Any repair or service must be performed
by authorized persons.

User Manual DIAcheck series Rev-7 Page 2

 Dialab GmbH

1. Introduction ........................................................................................................................................ 7

1.1 Symbols ....................................................................................................................................... 7

1.2 Views of the device ................................................................................................................. 8

1.3 Consumables / Accessories ................................................................................................. 9

1.4 Intended use........................................................................................................................... 10

1.4.1 Compare of DIAcheck series ...................................................................................................... 10

1.4.2 Test Methods .................................................................................................................................... 12

1.4.3 Specimen Collection ...................................................................................................................... 12

1.4.4 Principle of measurment ............................................................................................................. 13

1.4.5 Clotting method (PT, aPTT,..) .................................................................................................... 14

1.4.6 Chromogenic Method (Antithrombin): ................................................................................. 14

1.4.7 ImmunturbidimetriC Method (D-Dimer): ............................................................................ 14

1.5 Safety information ............................................................................................................... 15

1.5.1 Safety information for operation ............................................................................................. 15

1.5.2 Safety information for MATERIALS ........................................................................................ 15

1.5.3 Safety information regarding risk of health ........................................................................ 16

1.5.4 Safety information for cleaning, maintenance and servicing ....................................... 17

1.5.5 Electrical Safety ............................................................................................................................... 18

1.5.6 Recycling of the instrument ....................................................................................................... 18

2. Installation of the DIAcheck series .............................................................................................19

2.1 Scope of delivery................................................................................................................... 19

2.2 Conditions of operation ..................................................................................................... 20

2.3 First Installation ................................................................................................................... 21

2.4 Switching ON and off ........................................................................................................... 22

2.5 Display PRotection Foil ...................................................................................................... 22

2.6 External Thermal Printer .................................................................................................. 23

2.7 External Barcode Scanner ................................................................................................. 23

2.8 TECAM SMART ....................................................................................................................... 23

2.9 Registration ............................................................................................................................ 24

User Manual DIAcheck series Rev-7 Page 3

 Dialab GmbH

3. Operation of the DIAcheck series ................................................................................................25

3.1 Homescreen............................................................................................................................ 25

3.2 Input patient identification .............................................................................................. 26

3.3 Test selection ......................................................................................................................... 27

3.4 Measurement ......................................................................................................................... 28

3.5 System settings...................................................................................................................... 29

3.6 Test Settings ........................................................................................................................... 32

3.7 Review results ....................................................................................................................... 34

4. Basis coagulation tests ..................................................................................................................35

4.1 Quickguide of PT Determination .................................................................................... 35

4.2 Quickguide of PT-B Determination................................................................................ 36

4.3 Quickguide of aPTT Determination ............................................................................... 36

4.4 QuiCkguide of FIB Determination .................................................................................. 37

5. Ticket system.....................................................................................................................................38

6. SERVICE Functions ...........................................................................................................................40

6.1 System Information ............................................................................................................. 40

6.2 Optic Check ............................................................................................................................. 41

6.3 System report ........................................................................................................................ 42

6.4 Adjust temperature ............................................................................................................. 43

6.5 Firmware Update.................................................................................................................. 44

6.6 Overview of Mainboard...................................................................................................... 45

6.7 Typical Failures..................................................................................................................... 46

7. Reset to factory default ..................................................................................................................47

8. Working with TECAM Smart .........................................................................................................48

9. Cleaning and maintenance ...........................................................................................................49

9.1 General cleaning information .......................................................................................... 49

9.1 Cleaning ................................................................................................................................... 49

9.2 Decontamination .................................................................................................................. 49

9.3 Regular mainentance .......................................................................................................... 49

User Manual DIAcheck series Rev-7 Page 4

 Dialab GmbH

10. Technical Data ..................................................................................................................................50

User Manual DIAcheck series Rev-7 Page 5

 Dialab GmbH

List of figures

Figure 1: Top view .............................................................................................................................. 8

Figure 2: Rear view ............................................................................................................................ 8
Figure 3: Side vieW ............................................................................................................................ 8
Figure 4: Determination of turning point in clotting method ............................................................. 14
Figure 5: Standard Delivery package (picture will follow) ............................................................. 19
Figure 6: System Information ........................................................................................................... 24
Figure 7: Registration of DIAcheck series ........................................................................................ 24
Figure 8: Homescreen DIAcheck series C4 ..................................................................................... 25
Figure 9: Input Patient ID ................................................................................................................. 26
Figure 10: test selection DIAcheck series C2/C4 ............................................................................. 27
Figure 11: test selection DIAcheck series C1 .................................................................................. 27
Figure 12: Screen during measurement ........................................................................................... 28
Figure 13: Quickmenu DIAcheck series C2/C4 ................................................................................ 29
Figure 14: System settngs DIAcheck series C2/C4 ......................................................................... 31
Figure 15: Test setting 1 ................................................................................................................... 32
Figure 16: Test Setting 2 .................................................................................................................. 33
Figure 17: Review results ................................................................................................................. 34
Figure 18: QC Report ....................................................................................................................... 34
Figure 19: Ticket System, LOGIN .................................................................................................... 38
Figure 20: Ticket System, Voucher .................................................................................................. 38
Figure 21: Ticket System, Input Code .............................................................................................. 39
Figure 22: Ticket System, TECAM SMART ..................................................................................... 39
Figure 23: System Information ......................................................................................................... 40
Figure 24: Optic Check ..................................................................................................................... 41
Figure 25: Screenshot of XFlash tool ............................................................................................... 44
Figure 26: Mainboard ....................................................................................................................... 45
Figure 27: TECAM SMART .............................................................................................................. 48

User Manual DIAcheck series Rev-7 Page 6

 Dialab GmbH

1. INTRODUCTION

This device left the factory in fault-free condition regarding its safety and engineering
functionality. To maintain this condition and ensure risk-free operation, the operator
must comply with the safety warnings and information in this User Manual.

Use the DIAcheck series only in compliance with the instructions in this
User Manual. Otherwise, the manufacturer shall exclude the liability for any
damages to the DIAcheck series, patients or operators.

1.1 SYMBOLS
The following standard symbols are used in this manual:

Symbol Meaning Explanation

Courier Info Key on keypad

CAPS Info Screen message.

Read Indicates important information and tips.

Describes reaction of DIAcheck series to

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

Equipment can be potentially infectious

Biohazard
due to the samples and reagents used.

Laser Radiation Avoid direct eye exposure

User Manual DIAcheck series Rev-7 Page 7

 Dialab GmbH

1.2 VIEWS OF THE DEVICE

Home Screen (f.e. DIAcheck C4)

Coloured Touch Display

Complete area is prewarmed to 37°C

1 x Reagent position Ø24mm

1 x Reagent position Ø22mm
1 x Reagent position Ø22mm, stirred

2 x Reagent positions Ø13mm

20 x Cuvette incubation positions

4 x Cuvette measurement positions

(depend on C1/C2/C3 version)

FIGURE 1: TOP VIEW

5V: Power in (+ 5Vdc)

PC: USB: LIS or PC (USB)

SERVICE: Software update (USB)

PRINTER: Serial printer (RS232)

BARCODE: Handheld barcode scanner

(RS232)

FIGURE 2: REAR VIEW

FIGURE 3: SIDE VIEW

User Manual DIAcheck series Rev-7 Page 8

 Dialab GmbH

1.3 CONSUMABLES / ACCESSORIES

Cuvettes, P=500
with Voucher-Identification code (VID)

Stirring magnets, P=4

Required to mix PT reagent
Reagent container  22,5mm, P=100

Reagent tubes  11mm, P=100

Micro tubes, safe-lock, with cap  11mm, P=100

Reagent adapter, a 24,2mm - i 22,5mm

Helps to place vials with different sizes

Display protection foil Set

(Protection foil, Clean tissues, Remover)

TECAM Smart Software

Patient management, Reagent Calibration management, Monitoring, Research,
Statistics, Mirror print function, LIS communication (ASTM-1394)

Thermal printer, 57mm, wide range: 100-240Vac

Thermal paper, 57mm, P=5

Scanner CCD (1D, 2D)

Read 1D or QR code for Patient-ID, Reagent Info, Tickets

User Manual DIAcheck series Rev-7 Page 9

 Dialab GmbH

1.4 INTENDED USE

The DIAcheck series is designed to carry out coagulometric tests such as PT, PTT,
TT, fibrinogen, single factor tests, chromogenic and immunoturbidimetric tests
(for instance Antithrombin, D-dimer etc.) on human citrated plasma. The
instrument has to be used for the expected purposes and in perfect technical
condition, by qualified personnel, in working conditions and maintenance
operations as described in this document. It is designed for laboratory use or
clinical environment and trained users. It is not intended for home use.

1.4.1 COMPARE OF DIACHECK SERIES

The DIAcheck series include three different versions called C1, C2, C4

C1 C2 C4

DIAcheck series
Family

Reagent and Optic

prewarmed to 37°C
block
Cuvette prewarm 10x 20x 20x
Reagent prewarm,
1x 1x 1x
24mm
Reagent prewarm,
2x 2x 2x
22mm
Microtubes prewarm 2x 2x 2x

Reagent stirrer No 1x 1x

Printer, RS232 Yes

Barcode Scanner,
Yes, external or integrated 1D Barcode scanner
RS232
LIS, USB Yes

Firmware Update, USB Yes

Measurement

Optic channels 1 2 4

620nm 405nm 405nm

Optic wavelength
(RED) (UV) (UV)

Cuvette, total volume Single, 75µL Single, 75µL Single, 75µL

Global Clotting Assays PT+aPTT+Fib+TT PT+aPTT+Fib+TT PT+aPTT+Fib+TT

All factors All factors

Special Clotting Assays No
PS, LA PS,LA

User Manual DIAcheck series Rev-7 Page 10

 Dialab GmbH

Chromogenic Assays - AT, PC,HEP AT, PC,HEP

D-Dimer D-Dimer
Latex enhanced Assays D-Dimer
Free PS Free PS

Whole Blood Testing Yes (PT INR+%) No No

Software features
Reagent Dual LOT
No Yes Yes
manage two different lots for each test
Test Calibration
LOT, expiry and upto 5 points for each Yes Yes Yes
test
Reagent Barcode
Input LOT+Expiry or Positive LOT Yes Yes Yes
detection
Patient Barcode
Input patient ID by barcode scanner Yes Yes Yes
upto 16char
System Barcode
Input voucher tickets by barcode
Yes Yes Yes
scanner directly from display of smart
device
Result Database
Yes Yes Yes
save recent 180 results onboard
Double Determination
Run patient twice and display mean No Yes Yes
value
Stopwatch function
1x 2x 4x
count up or down incubation time
Result Identification
Yes Yes Yes
Patient ID or sample ID or Auto ID

Real Time Clock Yes Yes Yes

Change language
Yes Yes Yes
EN, ESP, ITA, FR, DE - further on option
Start test at reagent addition
Yes Yes Yes
No expensive starter pipette required
Visualize Reaction Curve
Yes Yes Yes
Tecmoni Software required
Link to LIS over USB or network/ASTM
Yes Yes Yes
TECAM SMART Software required

User Manual DIAcheck series Rev-7 Page 11

 Dialab GmbH

1.4.2 TEST METHODS

Following test are provided to detect of the human coagulation system, which can
be bleeding or thrombosis and the monitoring of anti-coagulation drugs like
Heparin or Marcumar.

DIAcheck series
Test Name Specimen Method
C1 C2 C4
PTB Prothrombin Time blood clot Yes No No
PT Prothrombin Time plasma clot Yes Yes Yes
Activated Partial
APTT plasma clot Yes Yes Yes
Prothrombin Time
FIB Fibrinogen plasma clot Yes Yes Yes
TT Thrombin Time plasma clot Yes Yes Yes
AT Antithrombin plasma chromogen No Yes Yes
DD D-Dimer plasma immuno Yes Yes Yes
Factors II, V, VII, VIII,
Factors plasma clot No Yes Yes
IX, X, XI, XII
HEP Heparin (anti Xa) plasma chromogen No Yes Yes
PC Protein C plasma chromogen No Yes Yes
PS Protein S plasma clot No Yes Yes
PSF Free Protein-S plasma immuno No Yes Yes
LA-S Lupus Screen plasma clot No Yes Yes
LA-C Lupus Confirm plasma clot No Yes Yes

1.4.3 SPECIMEN COLLECTION

Type: Human citrated plasma
Collection: Veinvein puncture, 1:10 mixed sodium citrate 3.2%
(0.105M)
Centrifugation: 10min at 1500g
Storage: Max 4h after collection at room temperature

Bilirubin: < 50mg/dl

Hemoglobin: < 9000mg/l
Triglyceride: < 2500g/l

Intended specimen for PTB for C1 only:

Type: Capillary blood from puncture of finger or citrated whole blood

In case of differences to the boxinserts of the reagent, always follow the

instructions on the box insert.

User Manual DIAcheck series Rev-7 Page 12

 Dialab GmbH

1.4.4 PRINCIPLE OF MEASURMENT

The detection of plasma clotting is based on a photometric principle. No mechanical aids

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

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

Unit Info Decimal Maximum

places value
s seconds 1 -
% activity 1 250.0
U units 0 29999
INR Int. ratio 2 99.00
R ratio 2 99.00
NR polish ratio 0 250
mg/dl 0 999
g/l 2 99
IE/ml Int. Units 2 99
mg/l 2 999
µg/ml 3 9.000
ng/ml 0 27500
µg/l 0 27500
IU/mL Int. Units 2 99.00

R = clotting time / normal time

NR = 100 *(normal time/clotting time)
INR = Ratio ISI (International Normal Ratio)
IU/mL = IE/mL = International Units (1.00 IU/mL = 100 % activity)

User Manual DIAcheck series Rev-7 Page 13

 Dialab GmbH

1.4.5 CLOTTING METHOD (PT, APTT,..)

FIGURE 4: DETERMINATION OF TURNING POINT IN CLOTTING METHOD

The final reaction in the coagulation cascade is the transformation of fibrinogen

into fibrin catalyzed by thrombin. Fibrin formation results in clouding (higher
turbidimetric level) in the sample, which is measured by the photometer and
stored as the extinction. The result in seconds is the time from the start of the
reaction to the time of half rate of change (halfpoint).

1.4.6 CHROMOGENIC METHOD (ANTITHROMBIN):

The change of optical signal is not caused by clot reaction, but by the release of
color particles (pNA) which causes a yellow color. The change of color is measured
at 405nm and expressed as “dE/60sec” and proportional to the concentration or
activity of analyte.

1.4.7 IMMUNTURBIDIMETRIC METHOD (D-DIMER):

The change of light is caused by Antigen – Antibody reactions, which scatter the
light. The antibodies are linked to latex particles to amplify the optical reaction. The
change of light is proportional to the concentration of antigen like D-Dimer and
expressed as dE/120sec

User Manual DIAcheck series Rev-7 Page 14

 Dialab GmbH

1.5 SAFETY INFORMATION

1.5.1 SAFETY INFORMATION FOR OPERATION

Use only the cleaning and rinsing liquids approved by the manufacturer. Failure
to do so could result in faulty measurements or malfunctions of the DIAcheck
series. Prevent reagents from leaking into the Analyzer. Failure to do so may
result in damage to the instrument and result in expensive maintenance work!

Carry out control measurements at regular intervals to ensure that the analyzer
continues to function faultlessly.

If the instrument is used in a manner not specified by the manufacturer, the

protection impairment could be affected!

Please read the Operation manual in its entirety prior to operation, in order to
ensure a high level of performance and to avoid errors by user.

1.5.2 SAFETY INFORMATION FOR MATERIALS

Use only Dialab approved and labeled material like cuvettes, spare parts or
reagents for which the instrument is intended and validated for.

Consumables like cuvettes or yellow tips are intended as single-use items.

Multiple use may result in false results due to contamination. Follow the
instructions on the reagent package circulars. Incorrect handling may result
in falsified results.

Do not use materials after their date of expiry. Especially expired IVD
reagents may cause false results.

Check correct function of manual pipette every year to ensure accurate

results.

User Manual DIAcheck series Rev-7 Page 15

 Dialab GmbH

1.5.3 SAFETY INFORMATION REGARDING RISK OF HEALTH

Bleeding or Thrombosis
Diagnosis and medication of human coagulation system based on false
results may lead to critical bleeding or thrombosis. For risk reduction it is
essential to follow the hints below.

Regarding risks:
Caused by faulty condition of the instrument, reagent or calibration data:
Perform a quality control before running a series of patient samples or after
reconstitution of a vial or after test calibration to eliminate failure of
theinstrument, reagent or calibration data.
Caused by imprecise pipet:
Validate your pipette every year and label it with the last date of validation.
Caused by false assignment of target values:
Run interlaboratory quality control standards.
Caused by purified water:
Use only high purified water to reconstitute controls or reagents. Check
visualy that the water is free of any particles.
Caused by expired reagent:
Do not use IVD reagents or other materials after their expiry date.
Infectious Material
Consider all surfaces and materials which might be in contact with plasma or
other biological liquid as potentially contaminated with infectious material.

Avoid contact:
Wear medical infection grade protective gloves for all works involving
potential contact with infectious material and use each pair of gloves only.
Use a hand disinfectant product, e.g. Sterillium®, to disinfect your hands after
completion of the work.

Dispose:
Dispose infectious materials, such as cuvette waste and liquid waste, in
compliance with your local regulations governing for infectious materials.

Hygienic conditions:
Validate your hygienic management system according to German GLP federal
bureau for good laboratory practice or similar quality standard. Any waste
material must be considered as potentially infectious. Direct contact must be
avoided. Protective gloves during operation, service or cleaning are required.

User Manual DIAcheck series Rev-7 Page 16

 Dialab GmbH

1.5.4 SAFETY INFORMATION FOR CLEANING, MAINTENANCE AND SERVICING

Authorized service only!

Carry out only the measures listed in this operator’s manual for maintenance,
repair and replacement. Improper manipulation of the device will void the
manufacturer's liability obligations and may make service calls necessary,
including payments which are not covered by warranty. Only the authorized
Customer Service may carry out servicing. Only original replacement parts
may be used. Before doing any servicing on the instrument, it is very
important to thoroughly disinfect all possibly contaminated parts.
Cleaning and decontamination
Before the instrument is removed from the laboratory for disposal or
servicing, it must be decontaminated. The procedure is described in chapter
“Cleaning and maintenance” and should be performed by authorised well-
trained personnel only, observing all necessary safety precautions
Cleaning certificate required!
Instruments to be returned have to be accompanied by a decontamination
certificate issued by the responsible laboratory manager. If a
decontamination certificate is not supplied, the returning laboratory will be
responsible for charges resulting from non-acceptance of the instrument by
the service centre, or from authority’s interventions.

Regard all surfaces and materials which might be in contact with plasma or
other biological liquid as potentially contaminated with infectious material.

Avoid any direct contact with decontaminants or disinfections.

User Manual DIAcheck series Rev-7 Page 17

 Dialab GmbH

1.5.5 ELECTRICAL SAFETY

Precautions:
 Avoid spilling liquids into system. In case of spilled liquids disconnect the
system from power, then clean and dry all contaminated parts.
 Remove the power cord before opening the instrument.
 Do not touch any electronic parts during operation.
 Do not operate system without proper connection to grounding.
 Never intentionally interrupt protective ground contacts.
 Never remove housing elements, protective covers or secured structural
elements, since doing so could expose parts carrying electric current.
 Make sure surfaces such as the floor and workbench are not moist while
operating the device.
 Check electrical equipement regulary. Defective leads or socket must be
replaced without delay.
Connection to power:
 Instrument is in compliance with IEC 61010-1 / 61010-2 and classified as
portable instrument, class II. It does not require a safety connection to
electrical earth.
 Make sure the operating voltage setting is correct before connecting the
device to the power mains. Read chapter “installation” about electrical
conditions.
 The power cord always has to be easily accessible during normal
operation.
EMC Statement:
The DIAcheck series it suitable for use in domestic and industrial
establishments. It was tested according to standards IEC 61326-1:2013 and
IEC 61326-2-6:2013, It is in compliance with the requirements
Emission: EN 55011, Class B, Group1
Immunity: EN 6100-4 -2,3,4,5,6,8
The maximum length of cables to external devices like printer, barcode or LIS
must be less than 3m to keep compliance with EMC

1.5.6 RECYCLING OF THE INSTRUMENT

The system must be decontaminated before being transported to an authorized

disposer for electrical waste.

The instrument must be recycled as required by guideline WEEE (2002/96/EG).

User Manual DIAcheck series Rev-7 Page 18

 Dialab GmbH

2. INSTALLATION OF THE DIACHECK SERIES

2.1 SCOPE OF DELIVERY

Contents of standard delivery package:

 1 Pc DIAcheck instrument
 1 Pc Power Supply
 2x100 Pcs Single cuvettes
 5 Pcs Reagent container, Ø22,5mm
 5 Pcs Reagent tubes, Ø11mm
 1 Pc Operation Manual (not on picture below)
 1 Pc Display protection foil
 1 Pc System ID-Card

FIGURE 5: STANDARD DELIVERY PACKAGE (PICTURE WILL FOLLOW)

Optional available:

 External Thermal Printer (RS232)

 External Barcode scanner (RS232)
 Printer cable
 TECAM Smart Software

User Manual DIAcheck series Rev-7 Page 19

 Dialab GmbH

2.2 CONDITIONS OF OPERATION

Ambient conditions:
Operating Temperature 15°C to 30 °C
Humidity < 70% rel. humidity
Elevation above NN sea level < 3,000m
Free of dust Grade 2
Impact resistance According to IEC/EN 61010-1, 8.2.2
Not allowed Vibrations, direct sun light and direct exposure
to air condition.

Electrical conditions:
100-240 VAC, 47 - 63Hz, no earthing required (Class-2)

Electrostatic Discharge (ESD):

No special requirements for ESD protection (shoes etc.)

Storage conditions:
0 - 50°C, max. 12 months in original package.

Transport conditions:
No special conditions required. The general regulations for transport can
be used.

Hygienic conditions:
Validate your hygienic management system according to international
applied Good Laboratory Practice (GLP) or similar quality standard. Any
waste material must be considered as potentially infectious. Direct contact
must be avoided. Protective gloves during operation, service or cleaning
are required.

Device environment:
No special requirements. Instruments is suitable for or use in domestic and
industrial establishments.

User Manual DIAcheck series Rev-7 Page 20

 Dialab GmbH

2.3 FIRST INSTALLATION

Inspect the packaging of the DIAcheck series and accessories for any visible external
damage. If the packaging is damaged, contact the transport company so that any damage
to the device or accessories can be assessed.

The instrument is ready to use and don’t need a specific procedure.

First installation procedure:

1. Unpack and place instrument in conformity with conditions of operation (see previous
chapter).
2. Install assessory (Protection foil, printer, barcode, Tecam – see next chapters)
3. Plug in power 5V.
4. Wait until green Status (approx. 15 min). The instrument is now ready to use.
5. Register instrument online for start of warranty period.
6. Activate 500 cuvettes (see chapter-5 “ticket system”).

Keep the original packaging material for purposes of later transport

maximum length of cables to external devices like printer, barcode or LIS

must be less than 3m to keep compliance with EMC

User Manual DIAcheck series Rev-7 Page 21

 Dialab GmbH

2.4 SWITCHING ON AND OFF

Switching on
Connect with power supply

Important Information:
The instrument requires about 15 minutes to heat up the optic block to 37°C. Afterwards
it is ready for measurement, indicated by a green dot in the top right corner of the display.
If the status symbol does not turn green, even after wating for 25 minutes, press the status
symbol to see the device status to identify the problem.

Switching off
The device supports no power switch. It must be disconnected from power. To do this,
unplug the power adapter from the socket on the device first and then disconnect the
power supply.

Standby
The system switches to standby after 2 minutes of idle operation. In standby mode, the
display brightness is reduced to save display life time and reduce power consumption. The
next touch anywhere on the display disables the standby mode.

Sleep
Open menu and touch the “sleep” button:

The menu bar is displayed on top of screen and only available, if no measurement is
ongoing. The power consumption during sleep is 0,2W.

Wakeup
To wake the device up from sleep, touch the display.

The system can be disconnected under any operation situations. There is no risk of
system damage

2.5 DISPLAY PROTECTION FOIL

Requirements:
Type: Touchseinsitive Protection foil, clean tissue wet and dry, Peel-off-
plate
Size: same as Display (4,3”)

Installation:
Ready to fix on display, as described in the Inlay
(clean display with clean tissues wet and dry and fix protection foil carefully)

User Manual DIAcheck series Rev-7 Page 22

 Dialab GmbH

2.6 EXTERNAL THERMAL PRINTER

Requirements:
Type: Serial RS232 Printer
Power: external supply, 24V 1.5A
Cable: 2 x Sub D9, female, straight, max length 3m
Interface: RS232, 9600 Baud, 8, 1, No

Installation:
The printer is ready to plug in. No settings are required.

Do not plug power supply of printer (24V) to DIAcheck series. It will destroy the
instrument! Double check before you plug-in.

2.7 EXTERNAL BARCODE SCANNER

Requirements:
Type: Serial handheld scanner
Power: 5V DC over cable, PIN-9
Cable: Included to scanner
Interface: RS232 9600 Baud, 8, 1, No
Setting: no handshake or protocol. Barcode must be finished with carriage
return.

Installation:
The scanner is ready to plug in. no settings are required.

2.8 TECAM SMART

Requirements:
License: TECAM SMART fingerprint and activation code.
Cable: USB, type A to B, max 3m
Interface: USB
Setting: no handshake or protocol. Barcode must be finished with carriage
return.

Installation:
a) Disconnect the device from PC.
b) Run setup.exe.
c) Confirm when asked to install DIAcheck series driver.
d) Connect device with PC.
e) Start TECAM

Further information available in chapter “8” or online help file of TECAM.

User Manual DIAcheck series Rev-7 Page 23

 Dialab GmbH

2.9 REGISTRATION
The instrument must be registered online for warranty or service issues

1) Open weblink www.dialab-reg.com or scan QR Code on System-ID-Card

with mobile device (tablet/phone)

2) Enter SIN + PIN of device

Both can be seen on instrument license plate (Type label) or during startup or on info
screen (touch green or red LED on home screen)

DIAcheck C4
Version: V01.03.49
www.dialab-reg.com
SIN: 03040 01234
PIN: 12345 67890
Det=241

FIGURE 6: SYSTEM INFORMATION

FIGURE 7: REGISTRATION OF DIACHECK SERIES

User Manual DIAcheck series Rev-7 Page 24

 Dialab GmbH

3. OPERATION OF THE DIACHECK SERIES

3.1 HOMESCREEN
After boot or home button following screen is displayed

FIGURE 8: HOMESCREEN DIACHECK SERIES C4

UI Element Element Name Use Function

(1) Date & Time Edit date
(2) Current test Change test
(3) Stopwatch Start/Reset stopwatch or countdown
(4) Menu or Home Open menu or return to main
(5) Status Dot Show device status/Open system information
(6) Multistart Activate all channels
Optic-Button Channel-1 is idle. Touch to enter new PID and activate
Active Channel is active. Touch or add reagent to start
(7)
Blinking orange Ongoing measurement. Touch to stop measurement
Current result Touch to enter new PID

Other functionality:
[LIS] Visible, if connected with LIS
Green LED System is ready for measurement
Red LED Indicate system problems. No measurement is possible.
37.0°C Temperature on reagent block.
Grayed buttons Use function is not possible during measurement.
Reduced brightness Screensaver mode. Touch to reactivate.
Long touch Repeat current function
Green Green = Ready to measure, no problems
Yellow Yellow = Ready to measure, minor problems
Red Red = Not ready to measure, major problems

User Manual DIAcheck series Rev-7 Page 25

 Dialab GmbH

3.2 INPUT PATIENT IDENTIFICATION

Call: Homescreen/Optic button

FIGURE 9: INPUT PATIENT ID

Button UI Element Use Function

Numeric keys 0-9, C, X Change or delete PID.
Increment PID. Use long touch feature
Increment -1 / +1
for easy change.
Enable very high detection sensitivity. Useful for high
Hi-Sense Hi-Sense
diluted or lipemic samples or "+++" results.

Additional:

Long touch - Press button > 2sec.

Sample barcode - Set PID to barcode

User Manual DIAcheck series Rev-7 Page 26

 Dialab GmbH

3.3 TEST SELECTION

Call: Homescreen/Test button

FIGURE 10: TEST SELECTION DIACHECK SERIES C2/C4

FIGURE 11: TEST SELECTION DIACHECK SERIES C1

Button UI Element Use Function

PT – F12 Select test.
Test keys
>> << Change test table
Activate two LOTs per test (not available
On / Off On / Off
for DIAcheck C1).
LOT 1/2 LOT 1 / LOT 2 Load calibration of LOT 1 or LOT 2 from memory.
OK < OK Confirm test for current channel.
All All Confirm test for all channels.
Settings Settings > Change test calibration.
Print Print Print current test testup.
Scan reagent Select current test and lot.
-
barcode A long beep indicates an invalid barcode or LOT.
Test Information Calibration data of current lot and test.
SETUP PT
Box Red values indicate invalid data.

About reagent barcode:

The barcode on reagent label can used to switch to correct Test and LOT. Before use of barcode,
the test LOT + Calibration must be entered in calibration menu (see chapter test setting)

User Manual DIAcheck series Rev-7 Page 27

 Dialab GmbH

3.4 MEASUREMENT

FIGURE 12: SCREEN DURING MEASUREMENT

Button (7) during measurment

PID Patient identification number (max 16 numbers).
Result PT = 12.5s, 115% 0,91 INR.
+++ = no clot reaction detected within runtime.
Flag f = very low fibrinogen (weak clot).
F = very high fibrinogen (strong clot).
* = Result is out of calibration.
X = double value deviate more than 15%.
Err T = temperatue not 36 - 38°C.
E = reagent expired.
S = light intensity too low.
Current optical absorbance. A change of
mOD
value > 50mOD indicates an ongoing clot reaction.
Timer Current time of measurement.

Grey blinking Optic is ready for start of measurement

Green blinking Measurement is started,

but cuvette can be mixed or touched.

Orange blinking Stop mixing and don’t touch cuvette anymore

User Manual DIAcheck series Rev-7 Page 28

 Dialab GmbH

3.5 SYSTEM SETTINGS

Menu and functions depend on instrument version C1 or C2/C4 !

Call: Homescreen/Menu button

FIGURE 13: QUICKMENU DIACHECK SERIES C2/C4

Button UI Element Use Function

Toggle Auto
Auto PID Enable/Disable the Auto PID feature.
PID
Double Toggle Double
Enable/Disable Double determination.
determination determination
Toggle
Countown Switch between Stopwatch and Countdown mode.
Countdown
Results Results Button Open the result history.
Setup Setup Button Open the system setup.
StandBy Put the device into sleep mode.
OK / Home
OK / Return to the home screen.
Button

Auto PID:

Using the Auto PID mode enables the user to let the device choose a consecutively numbered ID
for every measurement. By setting the ID manually you set the start ID. Every new channel
activation automatically sets the ID to the next higher number.

Auto PID mode must be enabled to use the Multistart feature!

User Manual DIAcheck series Rev-7 Page 29

 Dialab GmbH

Double determination:

When using double determination mode, the channels 1 / 2 (DIAcheck C2) respectively channels 1
/ 2 and 3 / 4 (DIAcheck C4) are combined to perform a test using the same ID twice. Both results
are combined by calculating the mean value.

Countdown:

Use the stopwatches in countdown mode. The period of countdown is defined by incubation time
of test (see “test settings”). When Countdown mode is enabled, the stopwatches count down give
alarm 5sec before zero.

Results:

Pressing the Results button opens the result history screen.

Setup:

Pressing the Setup button opens the system settings.

Pressing the Sleep Button sends the device into the sleep mode. To wake the device up, touch
anywhere on the screen.

OK Button / :

Pressing the OK or Home Button returns to the home screen.

User Manual DIAcheck series Rev-7 Page 30

 Dialab GmbH

Call: Homescreen / Menu / Setup

FIGURE 14: SYSTEM SETTNGS DIACHECK SERIES C2/C4

Setting/Buttons Use Function

Date Set system date, use long touch on “<” “>” to scroll
through the values faster.
Short touch on date change the format (EU / US)
Long touch on date reset to defaut date
Time Set the system clock. Long Touch the time to reset to
default.
Language Select the system language DE/EN/ESP/ITA/FR/RO/PL/..
EN, English, FI, Suomi,
DE, Deutsch, HR, Hrvatski,
ESP, Espanol, LV, Latviesu,
ITA, Italian, LT, Lietuviu,
FR, Francais, PT, Portugues,
RO, Romana, SE, Svenska,
PL, Polski, SK, Slovensky,
DA, Dansk, SI, Slovenscina,
NL, Nederlands, CS, Cestina,
SR Srpski HU, Magyar,

Mixer Some reagents like PT sediment and need to be stirred

(not visible for DIAcheck C1) Select here the mixer intensity (Low/Normal/High).
Insert vial and magnetic stirbar into middle position.
Change speed until stirbar ensures proper mixing.
Temp Correct the actual current temperature of the reagent
block. Long touch the temperature value will reset to
default. Detailed information can be read in chapter
“Adjust temperature”.
OK / Return to the home screen.
Info Open system information.
< / > In or decrement value. Use long touch to scroll

User Manual DIAcheck series Rev-7 Page 31

 Dialab GmbH

3.6 TEST SETTINGS

Call: Homescreen / Test button / Settings

FIGURE 15: TEST SETTING 1

Setting/Buttons UI Element Use Function

LOT LOT Number field Press the LOT text field to enter or change LOT number.
Expiry Expiry date field Press the expiry date value to select the field
Units Result Units field Press the unit values to select the field.
Incubation Incubation time Press the incubation value to select the field.
field
Stop Stop time field Press the stop time value to select the field.
In/Decrement + or - Change the value of the selected field.
Numeric keys 0 – 9 and C Keys for LOT entry. C=Clear
OK < OK Save settings and exit screen.
ESC ESC Exit to test selection without saving.
Open advanced test settings. Only visible for administrator
Admin Admin
user.
Settings Settings > Open test calibration settings (Screen test settings 2)
Barcode: LOT barcode entry Scan reagent barcode to input LOT and expiry.

LOT:
Enter the LOT of the used reagent for the selected test. If dual LOT is used, use the test selection
screen to choose LOT 1 or LOT 2. Both LOT numbers have individual test settings.

Expiry:
Enter the expiry date of the reagent for the selected test (and LOT).

Units:
Select the units used for the test results. The available unit is predefined for each test.

Incubation
Required waiting time until adding final reagent and start measurement. The time is used for
countdown.
Stop:
Some samples do not clot. Afer stop time instrument breask measurement and report “+++” (no
clot detect)

User Manual DIAcheck series Rev-7 Page 32

 Dialab GmbH

Call: Homescreen / Test button / Settings / Settings

FIGURE 16: TEST SETTING 2

Setting/Buttons UI Element Use Function

Calibration curve
Value fields Press a calibration value to select the field.
values
Increment Change values in small or big steps.
+, -, ++, --
Decrement Use long touch to repeat change
Double/Half 0.5x 2x Half or duplicate values
Delete DEL Delete the selected value.
Reset Reset Reset all values to default.
Calibrators CAL Shift all calibration points according to serial dilution
(1:1 1:2 1:4 …)
OK < OK Save settings and exit screen.
ESC ESC Exit screen without saving.

Calibration curve:
Input of Calibration points. Minimum 2 points, maximum 5 points.

Normal:
Reference value for normal clotting time like for PT (MNPT). Only shown, if unit is selected.

ISI:
International sensititivity index of PT reagent. Value is stated on reagent label.

R²:
Linearity of calibration depending on mathematic
R²<0.5 not linear Y=LIN linear interpolation
R²<0.9 moderate linear Y=1/X reciprocal linear interpolation
R²>0.9 high linear Y=logXY double logarithm interpolation

User Manual DIAcheck series Rev-7 Page 33

 Dialab GmbH

3.7 REVIEW RESULTS

The device holds automatically the recent 100 results into EEPROM memory. The most recent
result is shown first. If the result history exceeds the memory, then the oldest measurement
result is overwritten.

Call: Homescreen / Menu / Results

FIGURE 17: REVIEW RESULTS

Setting/Buttons Use Function

< > Scroll the results.
Filter (on,off) Scroll only current PID+Test
Print Print the shown result.
QC Print & display max. 14 values of current PID+Test
including mean and C.V. value.
QC REPORT
26.09.2019

System: DIAcheck C4
SIN : 01040 01234
Test: FIB
PID: 20190929
--------------------------------------------
FIGURE 18: QC REPORT 1 16.8s 159 mg/dl
2 17.1s 154 mg/dl
3 16.9s 157 mg/dl
4 16.2s 166 mg/dl
5 16.5s 163 mg/dl
6 16.4s 164 mg/dl
7 16.1s 168 mg/dl
--------------------------------------------
-
Mean: 16.6s 162 mg/dl
C.V. : 2.1% 2.9%

Reset Reset the result view to most recent result.

DEL Delete current result
ESC Exit screen.

User Manual DIAcheck series Rev-7 Page 34

 Dialab GmbH

4. BASIS COAGULATION TESTS

This section describes only rudimental how to run basic clotting tests on DIAcheck series.
Correct procedure may be different for specific reagents. Read and follow always the
procedure in boxinsert of reagent kit.

4.1 QUICKGUIDE OF PT DETERMINATION

How to run a PT measurement:

1. Switch on instrument and wait for green state (~ 15min until 37°C).
2. Reconstitute PT reagent and wait 30-60 min before next step.
3. Place PT vial into reagent block + stirring bar and let incubate for at least 5min.
4. Change test of channel 1 to “PT” by pressing on the current test.
5. Place empty cuvette into optic.
6. Pipet 25µL of sample into cuvette.
7. Press “00:00” to start the stopwatch and wait 120 seconds.
8. Press “OPTIC-1” and enter a PID or scan a sample barcode.
9. Add 50µL PT reagent, when “Active” is blinking. The measurement will start
automatically when adding the reagent.
10. Wait for result or touch optic button to abort.

Multi-Activation (not for DIAcheck C1)

1. Open menu and set Auto PID = On.
2. Place empty cuvettes into each channel and pipet 25µL of sample to each cuvette.
3. Press button multistart.
4. Add 50µl PT in to each cuvette from left to right.

How to calibrate a PT
1. Reconstitute calibrator and wait 15-30min before continue with next step
2. Calibrators
The target value of calibrator is state at certificate. I assume 100% as example
IBS, Owrens or NaCl2 solution can be used as sample diluent
a. 100%: Pipet 100µl calibrator into empty tube
b. 50%: Pipet 100µL 100% calibrator + 100µL diluent into empty tube
c. 25%: Pipet 100µL 50% calibrator + 100µL diluent into empty tube
d. 12.5%: Pipet 100µL 25% calibrator + 100µL diluent into empty tube
3. Run all 4 calibrators like patients and write down the clotting time
(double determination is recommended)
4. Enter PT settings and enter
a. correct LOT, Exp (read Barcode of vial label)
b. set UNITS to “INR + %”
c. Input Normal Time (=100% result) + ISI (see vial)
d. Input % calibration

User Manual DIAcheck series Rev-7 Page 35

 Dialab GmbH

4.2 QUICKGUIDE OF PT-B DETERMINATION

How to run a PT-B measurement from finger blood:
1. Switch on instrument and wait for green state (~ 15min until 37°C).
2. Change test to “PTB” by pressing on the current test.
3. Reconstitute PT-B with component-1 (Diluent) and wait 30-60 min before next step.
4. Add component-2 (CaCl2) to PT-B and wait again for 30-60 min before next step.
5. Place empty cuvette into optic or pre-incubation.
6. Pipet 150µL of PT-B into cuvette. The cuvette must be used within the next 10min.
7. Close PT-B vial and store in the refrigerator until next use. The reagent is stable for
30 days.
8. Press “OPTIC-1” and enter a PID or scan a sample barcode.
9. When “active” is blinking, pierce the finger and pipet 15µL capillary blood from finger
into cuvette.
10. Measurement should start. It is important to mix in the cuvette. For this lower the
pipet into cuvette and pump 10-15x up and down. Stop mixing latest when
countdown is zero.

How to calibrate a PTB

1. Reconstitute calibrator with 1.7mL and wait 15-30min
2. Calibrators
The target value of calibrator is state at certificate. I assume 100% as example
IBS, Owrens or NaCL solution can be used as sample diluent
a. 100%: Pipet 100µl calibrator into empty tube
b. 25%: Pipet 100µL 100% calibrator + 500µL diluent into empty tube
3. Run all calibrators like patients and write or print the clotting time
4. Enter PTB settings and enter
a. correct LOT, Exp
b. set UNITS to “INR + %”
c. Input Normal Time (=100% result) + ISI (see vial)
d. Input % calibration

4.3 QUICKGUIDE OF APTT DETERMINATION

How to run an aPTT measurement:
1. Switch on instrument and wait for green state (~ 15min until 37°C).
2. Change test to “APTT” by pressing on the current test.
3. Place CaCl into instrument let incubate for at least 5min.
4. Place empty cuvette into optic or pre-incubation.
5. Pipet 25µL of sample into cuvette.
6. Pipet 25µL of cold aPTT reagent into cuvette.
7. Press “00:00” to start the stopwatch and wait 180 - 300 seconds.
8. Short before end of incubation press “OPTIC-1” and enter a PID or scan a sample
barcode.
11. Add 25µL CaCl, when “Active” is blinking. The measurement will start automatically.
12. Wait for result or touch optic button to abort.

User Manual DIAcheck series Rev-7 Page 36

 Dialab GmbH

4.4 QUICKGUIDE OF FIB DETERMINATION

How to run a FIB measurement:

1. Switch on instrument and wait for green state (~ 15min until 37°C).
2. Change test to “FIB” by pressing on the current test.
3. Reconstitute FIB reagent and wait 30-60 min before next step.
4. Place FIB vial not into reagent block. Room temperature is ok.
5. Place empty cuvette into optic.
6. Pipet 10µL of sample into cuvette.
7. Pipet 90µL of IBS buffer into cuvette.
8. Press “00:00” to start the stopwatch and wait 120 seconds.
9. Press “OPTIC-1” and enter a PID or scan a sample barcode.
10. Add 50µL FIB reagent, when “Active” is blinking. The measurement will start
automatically when adding the reagent.
11. Wait for result or touch optic button to abort.

How to calibrate a FIB

1. Reconstitute calibrator and wait 15-30min before continue with next step
2. Calibrators
The target value of calibrator is state at certificate. I assume 300mg/dL as example

a. 600mg/dL: Pipet 50µl calibrator + 200µL IBS buffer into empty tube
b. 300mg/dL: Pipet 50µl calibrator + 4500µL IBS buffer into empty tube
c. 150mg/dL: Pipet 50µl calibrator + 950µL IBS buffer into empty tube
d. 75mg/dL: Pipet 50µl calibrator + 1950µL IBS buffer into empty tube

3. Run all 4 calibrators

a. Add 50µL of calibrator into cuvette
b. Add 25µL of FIB reagent to start measurement. Write clotting times to paper or
print,

4. Enter FIB settings and enter

a. correct LOT, Exp
b. set UNITS to “mg/dL”
c. Input mg/dl calibration

User Manual DIAcheck series Rev-7 Page 37

 Dialab GmbH

5. TICKET SYSTEM

1) Login to ticket system

webpage: www.dialab-reg.com

DIAcheck C4
Version: V01.03.49
www.dialab-reg.com
SIN: 03040 01234
PIN: 12345 67890
Det=241

Enter SIN and PIN of instrument! This information can be found on instrument license plate
(Type label) or on info screen.

FIGURE 19: TICKET SYSTEM, LOGIN

2) Input Voucher

Enter VIN and PIN Voucher is inside of Transfer Ticket code

of voucher cuvette box to instrument

FIGURE 20: TICKET SYSTEM, VOUCHER

User Manual DIAcheck series Rev-7 Page 38

 Dialab GmbH

3) Transfer ticket code to instrument

Open info screen (touch blinking RED LED) and then “Remaining tests=0”. The code can be
transfered by manual input, barcode scanner or TECAM SMART software.

FIGURE 21: TICKET SYSTEM, INPUT CODE

4) Using TECAM SMART software

FIGURE 22: TICKET SYSTEM, TECAM SMART

a) Use your mobile device and scan QR code or

“Get ticket”, if TECAM is connected to internet

b) Follow dialogue according to chapter (1)

c) Copy Paste the code and “send” to instrument

User Manual DIAcheck series Rev-7 Page 39

 Dialab GmbH

6. SERVICE FUNCTIONS

Only for authorized and trained persons. Unqualified modifications can cause troubles
and misfunction of the system!

6.1 SYSTEM INFORMATION

Call: Homescreen / green or red LED

DIAcheck C4
Version: V01.03.49
www.dialab-reg.com
SIN: 03040 01234
PIN: 12345 67890
Det=241

FIGURE 23: SYSTEM INFORMATION

UI Element Element Name Use Function

(1) - System version information
(2) OK Return to homescreen
Number of activates cuvettes.
(3) Remaining tests
Touch to activate new cuvettes
(4) Print Print out of system information
(5) ERR message Show current error
(6) Optik Check optic system
(7) - System error information
System information
Version of software, URL link to register or ticket system, system ident number (SIN), product ident number
(PIN). SIN+PIN is required for login to ticket system.

Remaining tests=0:
Latest at zero the system will stop operation and require to activate new cuvettes.

YELLOW warnings
Minor problems
Reagent expired Check expiry date of test
Remaining tests < 100 Activate cuvettes soon

RED warnings
System is not ready to measure
COMM= communication to LIS SWCORE = software memory overflow
EEPROM= EEPROM/memory error SENSOR = temperature sensor
TEMP= temperature not 36-38°C BATTERY = CR2032 on mainboard below 3V
OPTIC= optical system out of range

User Manual DIAcheck series Rev-7 Page 40

 Dialab GmbH

6.2 OPTIC CHECK

Call: Homescreen / green or red LED / Optic

FIGURE 24: OPTIC CHECK

Button Caption Use Function

(1)-(4) OPTIC xx Reset QC value
(5) I=mA Display and change intensity of LED
(6) OK Return to homescreen
(7) MAX Set all LED to max. intensity (42mA)
(8) Print Print system report (see next chapter)
(9) +/- Change temperature
(10) Reset Reset all channels and re-calibrate optic

Informations on screen Fault condition Troubleshoot

LO optic signal, when LED is off > 2900 Replace optic board
HI optic signal, when LED is on < 25000 Remove cuvette and touch "RESET"
QC noise of optic signal > 30 Touch button "OPTIC"
mA power of LED (intensity) not [3 - 12mA} Remove cuvette and touch "RESET"
TMP temperature in °C not [36.0 - 38.0°C] wait 15min
REF signal of temperature sensor not [48000 - 52000] adjust temperatur or replace sensor

User Manual DIAcheck series Rev-7 Page 41

 Dialab GmbH

6.3 SYSTEM REPORT

Call: Homescreen / green or red LED / Print

SYSTEM REPORT

22.08.2017 Date of report

System: DIAcheck name of system

Version: V1.03.49 software version
SIN : 03040 01234 system ident number
PIN: 12345 67890 product ident number

TEMP: 37.0°C temperature of optic and digital value

50981 (target=50992) of thermosensor

Optic: Optical values

Lo Hi mA Qc Lo= LED off
--------------------------------------------- Hi= LED on
1:2698 28822 5 6 OK mA= LED power
2:2698 29822 6 3 OK Qc= noise of optic
3:2698 30822 7 1 OK OK= no fault
4:2698 29822 6 0 OK !!= fault condition

PT= 123 count of performed tests

aPTT= 102
FIB= 100
DD= 0
AT= 0

TOTAL 325

Fault condition are described in chapter “optic check”

User Manual DIAcheck series Rev-7 Page 42

 Dialab GmbH

6.4 ADJUST TEMPERATURE

Call: Homescreen / Menu / Temperature

1. Switch on device and wait approx. 15min until system show 37°C on screen.

2. Fill a reagent tube/vial with 2 ml water and place it in a reagent position. Place a digital
thermometer in the reagent tube and let warm-up for approx. 10 min.

3. Press menu
Change current system temperature to value of thermometer. Wait 10min and repeat
procedure.

Typical problems:

Malfunction / Error Possible cause Measures

System heat not up to 37°C Sensor calibration is out of Reset to factory default as
range described in chapter “Hidden
Function”

System show 0.00°C Sensor is out of range Ambient temperature must

be 0 – 45°C.

Sensor or optic LED board is Replace LED board.

defect

User Manual DIAcheck series Rev-7 Page 43

 Dialab GmbH

6.5 FIRMWARE UPDATE

Only for authorized and trained persons. Sudden interruption of power or data
communication during update procedure will cause device not to boot anymore. In this
case, the instrument can be restored only by JTAG interface.

1. Download flashdisk.exe from manufacturer website. Contact local distributor to

receive correct URL address.

2. Flashdisk.exe is a selfrunning Winzip archive. A double click will start the update
dialogue. Some antivirus software may block selfrunning archiv. In this case extract
the file to your desktop and execute “Flash.exe”
Flash 1.04

DIAcheck Update: Firmware Version 01.03.49

Turn on your DIAcheck device

Software Changes
-----------------------
Release 1.03.49
21.3.2019

FIGURE 25: SCREENSHOT OF XFLASH TOOL

3. Confirm “Start Update”

4. Remove USB cable from instrument and confirm

5. Connect USB cable to instrument USB “Service” (=second USB port from left)

Flash will now identify the instrument and display “CONTINUE”. Abort Flash, if no
instrument is found and install device driver “FT232.exe” manually. The file is
included in the flashdisk archive.

6. Confirm “Start Update”. After this command the firmware will be transmitted to
instrument. There is no way to interrupt. After around 120s the update will be
finished.

7. Remove power and afterward USB cable from service port. Now connect power to
instrument. It should boot and show correct firmware version.

User Manual DIAcheck series Rev-7 Page 44

 Dialab GmbH

6.6 OVERVIEW OF MAINBOARD

FIGURE 26: MAINBOARD

Testpin Function:
TP1 = Systick Interval, must toogle each 1ms
TP2 = indicate reading of SD24
TP3 = draw homescreen
TP4 = Write to EEprom
TP5 = Read from to EEprom
Other = not used

Status LED:
green, permanent = everything OK
red, permanent = EEPROM error defect optic unit and/or mainboard
green, blink = Battery < 3.0V battery expired
red, blink = Temp sensor Optic not connected

User Manual DIAcheck series Rev-7 Page 45

 Dialab GmbH

6.7 TYPICAL FAILURES

Malfunction / Error Possible cause Measures By

System not ready different Open system info and User
check red errors
Remaining tests = 0 No cuvette activated Create a ticket User
ERR=Comm Mainboard defect replacement Authorized
service
ERR=SWCORE Software failure or bug Update firmware User
ERR=Sensor Temp sensor defect Replacement of optic Authorized
service
ERR=Temp Temperature out of 36- Wait 15min User
38°C
ERR=Optic Optic channel blocked or Remove cuvette from Authorized
LED defect optic or clean optic or service
replace optic
ERR=Battery Battery low power Replacement Authorized
service

False results Possible cause Measures

True, patient anti coagulated Remove cuvette and check
or bleeding with needle for clot
Check reagent with eyes for
flakes or clots. Run control
Reagent defect
No or false clot plasma to verify. Prepare new
detected vial. Check diluent/water
Instrument missed clot Increase MAX time
Low fibrinogen or optical
Repeat but activate hi-sense
interference (lipemic,
option
bilirubin, haemolytic)
False result (INR, %, Check calibration data and
Method not correct calibrated
mg/dl, ...) correct LOT

User Manual DIAcheck series Rev-7 Page 46

 Dialab GmbH

7. RESET TO FACTORY DEFAULT

System factory reset procedure:

WELCOME SCREEN + FACTORY DEFAULT

How to reset to factory default:

1. Press 3sec to spinner during boot up
2. Select “OK” Switch on device and switch to home screen
3. Confirm the reset

 Date, temperature and test calibration must be adjusted after a factory reset!!

Default values:
 Temperature sensor = 51000
 Mixer = 1;
 Language = EN;
 Double determination = OFF;
 Auto PID = ON;
 Countdown = OFF;
 All results stored on board are deleted
 All test calibration data are reset to default

Test calibration:

How to reset to factory input a PT calibration:

1. Switch on device and switch to home screen
2. Touch any test button
3. Change test to “PT” and touch “Setup” or scan barcode of PT vial
4. Enter LOT, expiry and select Units to “% + INR”

User Manual DIAcheck series Rev-7 Page 47

 Dialab GmbH

8. WORKING WITH TECAM S MART

 Detailed information about installation and operation be be read in the online

manual of TECAM. This is just a quick overview.

TECAM software is a small local LIS and combines laboratory data management, quality control and
research purpose in one. It connects the DIAcheck to the “big” LIS and and manange results in an
own local database. Flexible filters allow QC with Levey-Jennings graph and Westgard analysis. Each
result can be traced back to reagent lot and calibration.

Features Smart

Receive result from analyser The results can be reported and managed in a local database

Receive calibration curve

Visualize and manage calibration data for all reagents and LOT.
from analyser

Visualize the optical reaction for research, result verification or failure

Receive reaction curve
anaylsis

Patient information Connect Patient-ID with name and other information.

Talk to LIS with ASTM-1394 standard protocol

LIS communication Receive from LIS: Patient information
Send to LIS: Results

Power filters allow quality evey-Jennings graph and Westgard analysis for
Statistical analyze (QC)
controls as well as for patients

This is a powerful research tool to visualize raaction curve in real time. It is

integrated TECMONI
a great tool for reagent development or adapting nee tests to instrument

Mirror print Instead of expensive portable thermo printer, use TECAM as printer

Activation of cuvette in its easiest way. Connect to ticket system, receive

Ticket system
ticket and send to instrument

FIGURE 27: TECAM SMART

User Manual DIAcheck series Rev-7 Page 48

 Dialab GmbH

9. CLEANING AND MAINTENANCE

9.1 GENERAL CLEANING INFORMATION

 Clean with a lint free cotton cloth or stick
 Never pure any liquid into optic, working area or touch display
 Keep the device free of dust and moisture.
 If the device is soiled with liquids, remove the soiling with an absorbent cloth.
 If a liquid has accidentally been spilt or pipetted into a measurement channel, remove
power immediately and clean the measurement channel with pipette and a lint-free
cloth. Check the function of the optics in the menu SERVICE

Regard all surfaces and materials, which might be in contact with plasma or
other biological liquid as potentially contaminated with infectious material.

Avoid any direct contact with decontaminants or disinfections.

9.1 CLEANING
 Use microfiber tissue only and no liquid to clean the screen
 Clean and wipe up all spills around the working area with 5-10% diluted bleach
detergent or water.

9.2 DECONTAMINATION
 Use 30% diluted bleach and commercial disinfectant (e.g. Bacillol®AF)
 Decontaminate working area. Don’t apply liquid on display.

9.3 REGULAR MAINENTANCE

 No maintenance required

User Manual DIAcheck series Rev-7 Page 49

 Dialab GmbH

10. TECHNICAL DATA

Analyzer
Display capacitive touch sensitive TFT 4.3’’ 480x272
Measurement system 1-4 independent measurement channels
wavelength of LED 405 nm
Cuvette single channel cuvette for optical detection
Positions (prewarmed) 5 reagent positions at 36.5 – 37.5 °C
20 cuvette positions at 36.5 – 37.5°C
Reaction volumes Minimum total volume is 75 µl
Power supply
Nominal Input Voltage 100 – 240VAC, 47-63Hz
Maximal Input Current 0.7A rms
Output Power 5V DC, 5A
Batterie (mainboard) Lithium CR2032 3V
Power consumption max. = 14W sleep < 0.5W
Dimensions
Size (W x D x H) 225 x 150 x 90 mm
Weight 1.04 kg (without power supply)
Ambient conditions
See chapter “Installation”
Noise output
Operating noise max. 50 dBA
Interfaces
RS232 (Barcode) Sub-D9, female; 9600 Baud/8/1/N; Pin-9
powered with 5V DC. For external
handheld barcode scanner, serial printers
RS232 (Printer) Sub-D9 female; 9600 Baud/8/1/N; For
serial printers
USB (Service, Firmware Update) Type-B, female, 115200 Baud/8/1/N
USB (LIS) Type-B, female, 115200 Baud/8/1/N; For
LIS communication
Typical performance data
Test CV. Range
PT <3% 0-30 INR
APTT <3% 15 – 420s
FIB <7% 50-999mg/dL

User Manual DIAcheck series Rev-7 Page 50