USER MANUAL

DIAGON COAG4D

FOUR-CHANNEL SEMI-AUTOMATED
COAGULOMETER

VERSION: 2.11 ENG

Edition date: 27.01.17.

Complies with software version V 2.04 or later
 Diagon Ltd.
H 1047 Budapest, Baross u. 48-52.
tel: (+36 1) 369 6500
fax: (+36 1) 369 6301
e-mail: diagon@diagon.com
www.diagon.com

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1 INTRODUCTION ......................................................................................................................... 5

1.1 THE DEVICE .................................................................................................................................... 5

1.2 AREA OF USE .................................................................................................................................. 5
1.3 THE STRUCTURE OF THE DEVICE .......................................................................................................... 6
1.4 TECHNICAL PARAMETERS................................................................................................................... 8

2 OPERATING PRINCIPLE .............................................................................................................. 9

2.1 DETERMINATION OF CLOTTING TIME .................................................................................................... 9

2.2 RESULT CALCULATION AT CLOTTING TESTS ............................................................................................ 9
2.3 TURBIDIMETRIC MEASUREMENT ....................................................................................................... 10
2.4 RESULT CALCULATION AT TURBIDIMETRIC TESTS................................................................................... 10
2.5 CHROMOGENIC MEASUREMENT........................................................................................................ 11
2.6 RESULT CALCULATION AT CHROMOGENIC TESTS ................................................................................... 11

3 INSTALLATION ......................................................................................................................... 12

3.1 CHECKING ACCESSORIES .................................................................................................................. 12

3.2 INSTALLATION REQUIREMENTS ......................................................................................................... 12
3.3 CONNECTION TO THE ELECTRIC MAINS ............................................................................................... 13
3.4 CHECKING THE OPERABILITY OF THE DEVICE ......................................................................................... 13

4 SETTINGS ................................................................................................................................. 14

4.1 SETUP PARAMETERS AT NEPHELOMETRIC CLOTTING TESTS ..................................................................... 15

4.2 SETUP PARAMETERS AT TURBIDIMETRIC AND CHROMOGENIC TESTS ......................................................... 16

5 SYSTEM MENU ........................................................................................................................ 17

6 SAMPLE MEASUREMENT ......................................................................................................... 19

6.1 PREPARATION OF REAGENTS, SAMPLES AND OTHER MATERIALS ............................................................... 19

6.2 MEASUREMENT WINDOW ............................................................................................................... 20
6.3 SAMPLE IDENTIFICATION ................................................................................................................. 22
6.4 MEASUREMENT IN NORMAL MODE („SYSTEM→MEASURE→SPEED→<NORMAL>”) ................................. 23
6.5 QUICK MEASUREMENT („SYSTEM→MEASURE→SPEED→<QUICK>”) ..................................................... 25

7 CALIBRATION........................................................................................................................... 30

7.1 CALIBRATION OF CLOTTING TESTS ..................................................................................................... 30

7.2 CALIBRATION OF TURBIDIMETRIC TESTS .............................................................................................. 32
7.3 CALIBRATION OF CHROMOGENIC TESTS .............................................................................................. 32
7.4 PRODUCING DILUTION SERIES ........................................................................................................... 33

8 RETRIEVAL OF MEASURED DATA ............................................................................................. 34

8.1 FILTERING .................................................................................................................................... 35

8.2 DETAILED DISPLAY.......................................................................................................................... 36
8.3 ACTION WINDOW .......................................................................................................................... 37

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9 QUALITY CONTROL .................................................................................................................. 38

9.1 SETTING TARGET VALUES OF QC MATERIAL ......................................................................................... 38

9.2 CONTROL MEASUREMENTS .............................................................................................................. 40
9.3 PROCESSING THE CONTROL RESULTS .................................................................................................. 41

10 MAINTENANCE ........................................................................................................................ 43

10.1 CHANGING PRINTING PAPER ........................................................................................................ 43

10.2 CLEANING THE MEASURING UNIT ................................................................................................. 43
10.3 CLEANING THE SCREEN ............................................................................................................... 43
10.4 CLEANING THE HOUSING ............................................................................................................ 44
10.5 ACTION IN CASE OF MALFUNCTION ............................................................................................... 44
10.6 SCRAP .................................................................................................................................... 44

APPENDIX A ...................................................................................................................................... 45

ERROR MESSAGES ................................................................................................................................... 45

APPENDIX B ...................................................................................................................................... 46

USE OF DIAGON SCREENING, CLOTTING TEST REAGENTS IN THE COAG4D............................................................ 46

USE OF DIAGON TURBIDIMETRIC AND CHROMOGENIC REAGENTS IN THE COAG4D ................................................ 46

APPENDIX C ...................................................................................................................................... 47

MENU STRUCTURE................................................................................................................................... 47

APPENDIX D ...................................................................................................................................... 48

SYMBOLS USED ON THE INSTRUMENTS AND ACCESSORIES ................................................................................ 48

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 1 Introduction

1.1 The device

The Diagon Coag4D four-channel semi-automated
coagulometer is an in vitro diagnostics device for use in clinical
laboratories by personnel qualified in laboratory diagnostics and
trained by representative of Diagon Ltd. or the authorized
distributors.

1.2 Area of use

The Coag4D analyzer serves to determine the following
parameters:
Clotting tests
Screening tests (PT, APTT, Fibrinogen, TT)
Factors (II, V, VII, X, VIII, IX, XI, XII)
Inhibitors (APC, Protein S, LA)
Chromogenic (ATIII *, Protein C, Plasminogen)
Turbidimetric test
D-Dimer *
User defined tests
Nephelometric
Turbidimetric
Chromogenic

* The ATIII and D-Dimer tests are available only in Coag 4D with g-Coag4DDi reference
number.
If you have Coag 4D with g-Coag4Dm reference number and you want to measure ATIII and
D-Dimer please contact your dealer.

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1.3 The structure of the device
Printer cover
opening button

Printer cover
2nd master
USB connector

Touch screen

Incubated reagent
positions Incubation area

Status indicator Measurement

LED positions

Figure 1.1 Top view

1st master Power supply Serial port Slave USB

On/off switch USB connector unit connector connector

Figure 1.2 Rear view

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On/off switch
This switch is used to switch the device on and off.
Touch screen
By touching the appropriate part of the screen the user can
operate the analyzer program. The display is a color graphic
liquid crystal panel.
Incubation area
The incubation area is a monolithic aluminum block regulated to
37 °C. It includes 20 preheated cuvette positions, 4 measure-
ment locations and 2 reagent positions for 10 ml reagent vessels,
which is able to receive 4-ml reagent vessels applying the
adapter.
Reagent positions
There is a rotating magnetic field at the reagent positions,
which, by rotating the magnet rod placed in the reagent vessel,
intermittently mixes the reagents. The mixing can be switched
off.
Measurement locations
Four nephelometric measurement positions are available for the
measurement of coagulation parameters, measurement positions
1 and 4 are also suitable for photometric measurements.
Indicator LED:
There are four indicator LEDs associated with the measurement
positions to monitor their status.
Built-in printer:
This thermal printer prints out the results and other data. The
rubber paper forwarding roller opens up along with the cover to
make paper replacement simple.
Serial port:
9 pin connector for serial communication.
External power supply unit connector
GTM21097-4509 type power supply unit, with input voltage
100-240V AC, and output voltage and current of 9V DC 5A.

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 Warning!
The device may only be operated with its original power supply unit, otherwise the
precision of the measurements cannot be guaranteed! The use of a non-approved
power supply unit may cause radio frequency interference, and may lead to the
malfunctioning of the device!

Slave USB port

The analyzer can be connected to a computer via a USB cable as
an external device.
Master USB ports:
The 2 USB ports are for connecting an external printer, barcode
reader and external storage device.
Warning!
The external power supply unit and the serial link cable must not be connected to the
device when it is switched on. The standard USB devices are allowed to be connected
to the device when it is switched on!

1.4 Technical parameters

Power supply: external power supply
Voltages: 90-264V
Frequency: 47-63 Hz
Power usage: 65W
Max. power consumption: 1.6 A
Insulation class: II
Operating temperature: 15-30°C
Humidity: 10-85%
Storage temperature: -10 - +50°C
Physical specification: 200x320x80mm (analyzer)
120x60x30mm (power supply)
Weight: 2.55 kg

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 2 Operating principle

2.1 Determination of clotting time

The user mixes the blood plasma and the reagent in a plastic
cuvette with appropriate timing. The cuvette is placed in the
measurement hole in the measurement block kept at a stable
temperature. The color of the inner surface of the hole is black
to avoid light reflections. The content of the cuvette is
illuminated with a 640 nm wavelength, monochromatic,
controlled light source.
The photo detector is positioned at 90 degrees to the direction of
illumination. When testing coagulation a specific volume of
blood is incubated then mixed with reagent whereby coagulation
process starts in the mixture (fibrinogen becomes fibrin). As
long as there is no coagulant in the mixture the dispersion of
light at 90 degrees is low, as coagulation starts the dispersion of
light gradually increases, until complete coagulation takes place.
Coagulation time starts when the reaction mixture is mixed
together, the end can be determined from the time function of
the strength of the light dispersion.
In the Setup menu, the Algorithm plays a role in the
determination of the endpoint of the coagulation time.

2.2 Result calculation at Clotting tests

Rate
Rate=time/Normal Value
Where time is the measured coagulation time, Normal Value is
the mean coagulation time of normal plasma.
INR (International Normalized Ratio)
Power method calculated INR: INR (Power)=RateISI
Where ISI=International Sensitivity Index
Concentration / Percentage
The concentration or the percentage value can be calculated
form the blood coagulation time (s). The program of the device
places a calibration curve on the input function points, and on
the basis of the curve unknown concentration or percentage

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 values can be determined from the measured coagulation time.
The points of the calibration curve can be given by the reagent
manufacturer (at certain manufacturer tests), in the lack of this
they have to be determined by the user from a dilution series.
INR (Calibrated)
A calibration curve may also be used to determine the INR
value, which is a function of the INR and the coagulation time.
The points of the curve are provided by the reagent
manufacturer on the basis of a known INR value calibration
series. The input of the points is the same as the input of the
points of the coagulation time-concentration function points.

2.3 Turbidimetric measurement

The instrument has a special version which can measure D-
Dimer where measurement positions 1 contain photometer units
operating at a wavelength of 570 nm.
In this immunology method specific volume of sample is
incubated for a certain time then immunology reagent dispensed
to the sample whereby the antibody-antigen binding form
creates optical turbidity which changes the light intensity in a
given wavelength. The light intensity change is proportional
with the concentration of the reaction mixture.
The instrument measures the optical density (OD) first after the
sample and starter reagent has been mixed then for the second
time some minutes later. The first value means the OD while the
second one is the OD at the endpoint of the reaction. The
changes of light intensity is given in ΔOD.

2.4 Result calculation at Turbidimetric tests

Concentration
The concentration value (µg FEU/ml) can be calculated form the
light intensity changing (ΔOD). The program of the device
places a calibration curve on the input function points, and on
the basis of the curve unknown concentration values can be
determined from the measured light intensity changing. The
points of the calibration curve can be given by the reagent

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 manufacturer (at certain manufacturer tests), in the lack of this
they have to be determined by the user from a dilution series.

2.5 Chromogenic measurement

The instrument has a special version which can measure AT III
where measurement positions 4 contain photometer units
operating at a wavelength of 405 nm.
In this chromogenic method specific volume of sample is
incubated for a certain time then reagent and substrate dispensed
to the sample whereby creates optical changes in transmitted
light in a given wavelength. The transmitted light intensity
change is proportional with the relative concentration of the
reaction mixture.
The instrument measures the optical density (OD) first after the
sample and starter reagent has been mixed then for the second
time some minutes later. The first value means the OD while the
second one is the OD at the endpoint of the reaction. The
changes of light intensity per minute is given in OD/min.

2.6 Result calculation at Chromogenic tests

Percentage
The percentage value can be calculated form the transmitted
light intensity changing per minute (OD/min). The program of
the device places a calibration curve on the input function
points, and on the basis of the curve unknown relative
concentration values can be determined from the measured light
intensity changing. The points of the calibration curve have to
be determined by the user from a dilution series.

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 3 Installation
Installation may be carried out by trained laboratory personnel
or by the service staff of the distributors authorized by Diagon
Ltd.

3.1 Checking accessories

After unpacking check that all the accessories are present on the
basis of the following list:
Coag4D analyzer 1pc.
Power supply unit 1pc.
Electric cable 1pc.
Magnetic mixer (2pcs/set) 1 set
Cuvettes (500pcs/kit) 1kit
Thermal paper 1pc
Adapter for 4 ml reagent vessels 2 pcs
User Manual 1pc
Protective cover 1pc

Check that the input voltage of the power unit complies with the
voltage of the local mains, and that the mains cable connector
fits into the wall power socket. If there is any discrepancy please
inform Diagon Ltd’s service department or the distributor.
Warning!
The device can only be operated with an undamaged, factory-provided cable, power
unit cover and device cable! Damaged cables may cause electric shocks or faults in
the device!
Damaged insulation can cause electric shock!

3.2 Installation requirements

For installation the device requires an empty space of 500x500
mm on a horizontal laboratory table. Do not place the analyzer
near any devices that cause mechanical vibrations. The
installation location should have an earthed mains power
connector, input current max. 1.5 A.

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 Warning!
The device must not be placed in direct sunlight!

3.3 Connection to the electric mains

First connect the DC cable of the power unit to the socket on the
rear of the device, then connect the mains connection cable to
the mains input socket of the power unit, then finally plug the
mains connection cable into the wall socket.

3.4 Checking the operability of the device

Switch on the device and check that the main menu appears
immediately (figure 3.1). Check the displayed temperature and
wait until the displayed temperature display changes to green.
The device only permits measurements within the prescribed
range (37 C+-0.1).

Figure 3.1 Main menu

Check the operation of the display, touch any “button” on the

screen surface, the display content will change depending on
what the role of the button is. Touching the “Esc” icon takes the
program back to the main menu.
Verify that the proper date and time are displayed, if not set
them in the “System” menu.

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 4 Settings
Select the “Setup” function in the main menu, and then select
the test to be set up on the following screen (see figure 4.1).

Figure 4.1 Test selection screen

After selecting the test the test parameter setting screen appears.
- On touching the “Print” button the parameters of the selected
test are printed out.
- The name of the selected test appears in the field with a
black background, the parameters that may be adjusted
appear with an orange background.
- Using the up and down arrows you can select parameters to
be changed.
- On touching the keyboard icon a keyboard appears with
which the parameter values can be adjusted. The buttons of
the keyboard change depending on which parameter is to be
adjusted.
Warning!
Before setting up any changes (first pressing the keyboard icon) user has to enter user
code on the virtual keyboard. Allowance is in effect until next switching off the
instrument. Ask the default user code from the Diagon authorized distributor or
service engineer!

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 - On touching the “X” icon the program exits without saving
any of the changes, but on touching the “ “ icon the
changes are saved when exiting.

4.1 Setup parameters at nephelometric Clotting tests

Min. time
It is the minimum time that can be measured. If the reaction time
is shorter than this time, then the result is marked with T flag.
Max. time
It is the maximum time that can be measured. If the system does
not sense the end of the reaction, it stops the measurement and
marks the result with T flag.
Lag time
During this time the program disregards changes in the cuvette.
Reagent nr.
It is for identifying the number of reagents.
Incubation time
It is waiting time between adding the sample and adding the
start reagent, during this period the sample is incubated at 37 C.

Figure 4.2 Test setup menu

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 Algorithm
It is a calculation way of evaluating the coagulation curve,
where:
1. for PT, APTT, Factors and Inhibitors
2. for TT
3. for Fibrinogen
Dimension
Measurement unit, it can be time, percentage, INR Power, INR
Calib. or concentration. Either INR Power or INR Calib., are
further processed as INR.
Parallel
In order to reduce the imprecision results originating from the
manual pipetting the measurement can be performed on two
parallel channels. If the difference of the two results is within a
given percent range the reported result will be the average of the
two. If out of the range the result will be flagged by “D”. The
button (right side on the middle) showing the given percentage
value for the range can be used to set the desired range up to
50%.

4.2 Setup parameters at Turbidimetric and Chromogenic tests

First time
It is elapsed time from creating the reaction mixture until first
reading.
Second time
It is elapsed time from creating the reaction mixture until
reaction has been completed.
Reagent nr.
It is for identifying the number of reagents.
Incubation time
It is waiting time between adding the sample and adding the
start reagent, during this period the sample is incubated at 37 C.
Dimension
It is the unit of the result which can be % and µg FEU/ml
(microgram fibrinogen equivalence unit/mL).

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 5 System menu
If you touch the “System” button, the system settings menu is displayed. The possible
settings are as below:
Language English Chinese French
Hungarian Russian Polish
Portuguese Spanish German
Italiano Vietnamese

Date / Time Format

Date
Time

Settings Sound Off – Lo – Hi

Mixer Off-On Reagent mixing off/on
Printer Off – On
Print header Off

Measure

Figure 5.1 Measure modes

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Identification
There are two possible modes of sample identification:
ID mode: Sample identification on the basis of ID, it can be
typed in manually or with the help of a barcode reader.
SN mode: The device automatically increases the serial number.
It is not advisable to change it because of the safety of sample
identification.
If the automatically generated ID number will be over written
the ID for the next sample will be requested to be entered
manually.
Speed
The incubation positions can be used for incubation and the
cuvettes have to be moved to measurement positions by rows
when the incubation time is up. In normal mode only the four
measurement position are used for measuring process.
See details in chapters 6.4-5.
Error messages
List of flagged measurements sorted by time. When touching the
“i” button program displays explanations of the flags.

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 6 Sample measurement

6.1 Preparation of reagents, samples and other materials

Only Diagon reagents produced in strict accordance with the
requirements are recommended for measurement The producer
cannot accept any responsibility for the accuracy of any test
results produced if you use reagent manufactured by anyone
other than Diagon.
The customer is liable to read the attached reagent insert
carefully and handle the reagents accordingly.
Before initiating any measurement make certain of using the
same reagent (check the lot number) what is entered into
calibration menu.
For sample measurement use freshly decalcified plasma
according to proper guidelines.
It is highly recommended to use bar code for sample
identification.
Only cuvettes distributed by Diagon Ltd. are allowed to be used
for measurement. Diagon Ltd. cannot accept any responsibility
for the accuracy of any test results produced if you use cuvettes
distributed by anyone other than Diagon Ltd..
Warning!
It is mandatory disposing used cuvettes!
In order to accelerate the whole measurement cycle it is
recommended to use separate pipette for sample and reagent
dispensing. The same pipette tip can be used dispensing the
same reagent but for samples dispensing, the tips have to be
replaced by samples in order to avoid carryover.
Warning!
The reagents and samples used during the measurements should be handled as
infectious materials! The prescriptions of the laboratory must be observed when they
are used! Emptied and used vessels and equipment must be collected and removed
separately, according to the prescriptions relating to handling infectious materials.

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6.2 Measurement window
The user must check that the correct date and time are displayed
on the screen by the analyzer just before starting the
measurement in order to be able to properly retrieve the results
later on at any time.
Sample measurement can be actuated by touching the
“Measure” button in the main menu when the sample selecting
input window comes up (figure 6.1). After selecting the desired
test, in the case of “ID Mode” the display will be changed
immediately to “Measuring” window, while in “SN Mode” only
after entering the starting ID. The areas of this window are the
following.
Sample Identifier
This window shows the sample ID in the current sample
position. If the “Double mode” is on only two sample identifiers
can be stated at the same time, suiting the two channels on the
left and the two channels on the right.
Time counter (sec)
It is the time of incubation or coagulation or measurement.
Status row
It shows either the actual status of measurement process or
required action from user.

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 Result
The results appear here according to the setup of “System“ and
“Setup” menu. The last result is always on the lowest position.

Header of result
Result

Sample Identifier

Status row
Time counter

Figure 6.1 Measurement window

Header of result
Head of the columns of results
IDs of incubated samples
The ID can be entered. Only in “Quick mode” (see figure 6.5.)
has an additional row. Transferring the sample to measurement
position the ID will be automatically transposed to “Sample
Identifier” field.
Incubation control
It is visible only in “Quick mode” (see figure 6.5). This is used
to start and display incubation time and after transferring the
row of cuvettes to measuring positions then touching this control
field (which shows the current incubation time in second), the
value will be written into time counter.

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6.3 Sample identification
SN Mode
Measurements are to be started by touching the “Measure”
button and choosing test in test selection screen. If SN mode
was selected previously in “System-Measure-Speed” menu, a
virtual keyboard comes up for entering the first identifier of
measured samples. The further identifiers will be generated
automatically; the program increases the previous identifier by 1
sequentially.
The identifier can contain normal and capital letters, characters
such as _ . / - ( # ) and spaces, which can be accessed by
pressing the “ABC”.
If the automatically generated ID number will be overwritten the
ID for the next sample will be requested to be entered manually.
A similar virtual keyboard will be displayed always when ID
entering field is selected. If barcode reader is used for sample
identification the code should be read here.

Figure 6.2 Entering the sample identifier

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ID Mode
The sample identifier window is blank. Step into this field and
the virtual keyboard will come up and the ID can be entered. If
you place a sample into measuring position without specifying
the ID the instrument warns with question mark.
Double (parallel) mode
Only two sample identifiers can be stated at the same time,
suiting the two channels on the left and the two channels on the
right. In other respects the measurement process is the same as
above. If this mode is off each measurement position has its own
ID.

6.4 Measurement in normal mode

(„System→Measure→Speed→<Normal>”)
Press “Measure” then select the desired test (e.g. “PT”). If
“SN” mode was selected previously in the “System” menu
(“System→Measure→Mode”) than the “First Sequence
Number” window comes up where the first sequence number
can be entered (the default value is 1). This number will be the
identifier of the first sample (on the left side position) and will
be increased by the instrument for the subsequent samples.
Note: the automatically generated ID number can be over
written after touching the “Sample Identifier” field.
In case “ID” mode was selected previously in the “System”
menu (“System→Measure→Mode”) by touching the “Sample
Identifier” field the sample ID can be entered using the virtual
keyboard.
Note: until ID has not been entered the measurement cannot be
started and the field contains a “?”.
The first column of the table contains the different steps of the
testing cycle of the sample and the rest of the columns show the
state of status indicators after performing the actual step.

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 Status indicator
Time counter Status row
LED
1. Ready for testing Green zero Add Tube * Continuous green
2. Add cuvette(s) to
Green zero Add Sample Blinking green
sample area
3. Add sample
according to the Continuous
Start incubation time Incubating
protocol descri-bed orange
in the appendix
4. Incubation time is
Incubation time in red Add Reag. Blinking orange
over (sound signal)
5. Add reagent Start measuring time Measuring Continuous red
6. Test completed Measuring time in
Tube Out * Blinking red
white
7. Remove cuvette(s) Green zero Add Tube * Continuous green

Warning!
When dispensing the starter reagent the pipette tip should not touch the cuvette.
Hold the pipette over the centre of the cuvette and dispense the reagent with an
energetic pressure.

In case of unintended operation user can correct the mistake.

Touching the time counter field two pushbuttons appear for two
seconds as you can see on figure 6.3.

Figure 6.3. Step correction pushbuttons

Touching them the workflow of regarding measurement can be

stepped forward or backward regarding the measurement flow
table.

24
6.5 Quick measurement („System→Measure→Speed→<Quick>”)
In order to make the whole measuring process more effectively
with those assays where the measuring time is less than the
incubation time the incubation area with the 5 rows can be used
for incubating the samples.
Note: this operating mode requires experience and special
attention whereas the incubation area has no sensor for
cuvette detection. The operator must keep the same order of
rows on the screen and in the incubation area. Furthermore it
is important that the four samples which are in the same row
have to be transferred to the measuring position keeping the
same order.
The identification for samples which are in measurement
positions should be performed as described in chapter 6.4 and
the measurement cycle should be accomplished according to the
table below.
Note: until the incubation time for measured samples has not
been started the fields of the additional row are blank.
In the example (see figure 6.5) the additional row on the screen
contains the information of the samples are in the first row of
the incubation area. The windows of this row are blank until the
3rd step (see table below) has not been completed for all samples
are in the measurement positions.

25
 Status indicator
Time counter Status row
LED
1. Ready for testing Green zero Add Tube Continuous green
2. Add cuvette(s) to
sample and Green zero Add Sample Blinking green
incubation area
3. Add sample
according to the Continuous
Start incubation time Incubate
protocol described orange
in the appendix
4. Incubation time is
Incubation time in red Add Reag. Blinking orange
over (sound signal)
5. Add reagent Start measuring time Measure Continuous red
6. Test completed Measuring time in
Tube Out Blinking red
white
7. Remove cuvette Green zero Add Tube Continuous green

Warning!
When dispensing the starter reagent the pipette tip should not touch the cuvette.
Hold the pipette over the centre of the cuvette and dispense the reagent with an
energetic pressure.

In case of unintended operation user can correct the mistake.

Touching the time counter field two pushbuttons appear for two
seconds as you can see on figure 6.3.
Touching them the workflow of regarding measurement can be
stepped forward or backward regarding the measurement flow
table.
The measuring process for samples is in incubation positions are
the following:
A. Press “Measure” then select the desired assay for testing
(e.g.”PT”).
B. If “SN” mode was selected previously in the “System”
menu (“System→Measure→Mode”) then the “First Sequence
Number” window comes up where the first sequence number
can be entered (the default value is 1). This number will be the
identifier of the first sample (on the left side position) and will

26
be increased by the instrument for the next 4 subsequent
samples whereas the instrument can store IDs of the row.
Note: the automatically generated ID number can be over
written after touching the “IDs of Incubated Sample” field
using the virtual keyboard.
In case “ID” mode was selected previously in the “System”
menu (“System→Measure→Mode”) by touching the “IDs of
Incubated Sample” field (default content is “?”) the sample ID
can be entered using the virtual keyboard.
Note: until ID has not been entered the measurement cannot
be started and the field contains a “?”.
C. Add cuvettes to the incubation and sample positions (see
figure 6.6) and then add the prepared and adequate quantity of
sample into the cuvettes as prescribed in the measurement
protocol (see appendix).
D. The measuring process for those samples which are in
the measuring positions is the same as it is in normal mode (see
table below).
Note: the first column of the table below contains the
different steps of the testing cycle of the sample and the rest
of the columns shows the state of status indicators after
performing the actual step.
E. After performing Step 3 (see table below) – depending
on the ID mode – the “IDs of Incubated Sample” field contains
“?” or the automatically incremented IDs and the “Incubation
control” field changes from blank to “Start” label.
If the instrument is in “ID mode” the IDs can be entered using
the virtual keyboard after touching the”?” field.
By pressing the field containing ”Start” label it will change to a
timer which count the incubation time.
F. Transfer the cuvettes from the incubation area to the
measuring place. The current incubation time and IDs will be
automatically transferred to the “Sample Identifier” and “Time
Counter” fields while the “Incubation Control” field will be
changed to “Start” and the “IDs of Incubated Sample” field
will show “?” or the next incremented IDs.

27
 G. The above described row on the screen can be used for
entering IDs and measuring incubation time of the next row in
the incubation area (see example, marked 2, figure 6.6)
according to paragraph B.
H. If the incubation time of transferred samples are up
continue the measuring process from paragraph 5 in the table
above.
I. The cycle starting with paragraph B can be continued
until samples need to be tested.

ID of incubated samples

Incubation control
1

Figure 6.5. Measurement screen in „Quick” mode

Note: until the incubation time for measured samples has not
been started the fields of the additional row are blank.

28
 5

Figure 6.6. Incubation area

29
 7 Calibration
In the case of the coagulometer calibration means entering
numerical data on the basis of which the program of the device
determines the test result from the measured coagulation time in
the measurement unit prescribed in the settings. For determining
the measured result it is necessary and it is possible to record the
LOT number of the reagents and calibrators used during the
measurement too.
The program of the device makes it possible to enter the
calibration data in the device using a barcode reader rather than
the touch screen, as a result of which the time between changing
the reagents can be reduced as well as the possibility of input
errors. If necessary, the content of the barcode can also be typed
in the program directly. The barcode can contain 16 number or
letter characters in each one of the three lines. Only the data of
the barcode system used by Diagon is interpreted correctly by
the program!
In the Setup menu, the measurement unit defined in the
Dimension line determines the system of the data needed for
calibration.
- In the case of selecting Rate setting the mean coagulation time
of normal plasma, that is the Normal Value, e.g. Mean Normal
Prothrombin Time (MNPT) in the case of PT.
- In the case of INR setting Normal Value and ISI.
- In the case of concentration, percentage or INR CALIB., two
pieces of data of maximum 6 calibration points.

7.1 Calibration of Clotting tests

Select the test to be calibrated in the Main menu – Calibration
– Test. Now you are in the calibration menu of the selected test,
in our example the PT calibration menu can be seen in figure
7.1.
1. Select the Reagent menu point to state the data of the
reagent or reagents in respect of which the given calibration is

30
 valid. These are the name, the LOT number, the year and the
month of expiry date of reagent.
2. Select the Barcode menu point to enter the content of the
barcode with the help of the barcode reader connected to the
USB port, or by typing it in. After pressing the OK button the
barcode data becomes valid and the program fills in the
calibration data.
3. Selecting INR the Normal Value (MNPT) and ISI value
should be entered for determining the INR using the power
method.

Figure 7.1 Calibration menu

4. When selecting % the calibration curve menu is

displayed to enter percentage, concentration or INR CALIB.
output calibration curve. Here, if necessary, the name, the LOT
number and expiration date of the calibrator used can be
recorded by pressing Calibrator button. The label of this button
can be changed by the user expediently for the name of the
calibrator.
If you select Points, the program asks for the correlative % or
concentration and coagulation time data pairs one by one. The
typed in data pair is displayed in the position marked orange. If

31
 an already existing data needs to be modified, the red mark can
be moved to the next line by entering and then exiting using the
ESC button. If fewer than six items of data are available, the last
lines must be filled with 0,0.
5. In the case of concentration and INR CALIB. output the same
procedure must be followed.
6. The final results are calculated according to the selection
(done by “Fit” button) of the type of calibration curve which is
calculated by the entered data pairs.
The type of calibration curves are the following: Lin-Lin, Lin-
Inv, Log-Log, Lin-Lin p-p, Lin-Inv p-p Log-Log p-p.
The factory set is Lin-Inv for PT and Log-Log for Fibrinogen.
The calibration curve can be drawn on the screen using the
Graph function.
The calibration curve menu is shown in figure 7.2.

7.2 Calibration of Turbidimetric tests

The left column of the calibration screen contains the
concentration values in µgFEU/ml unit and the right column the
ΔOD values. These values of the calibration curve are defined
by Diagon or can be recorded by measuring specific calibrators.

7.3 Calibration of Chromogenic tests

The left column of the calibration screen contains the percentage
values in % unit and the right column the OD/min values. These
values of the calibration curve can be recorded by measuring
specific calibrators.

32
7.4 Producing dilution series
The reagent manufacturer may provide the data of the
calibration curves specific to the device. If it is not available, the
dilution series needed for determining the points must be
produced by the user from normal plasma. The coagulation time
of the elements of the line must be measured one by one and
entered in the above program point. The reagent manufacturers
distribute the buffer solutions needed for producing dilutions.

Figure 7.2 Calibration curve menu

33
 8 Retrieval of measured data
In its present construction the device stores the data of 1 000
patients in the format shown in figure 8.1.

Figure 8.1 Result display

In each line of the list there is a test in chronological order. You

can step forwards and backwards in the table using the arrow
function buttons. By pressing the “dot” icon you can select the
current measurement for further processing. The mark
disappears when you exit the main menu.

34
8.1 Filtering
By using the “Filter” function on the left, the series of displayed
samples can be narrowed down with the help of the menu shown
in figure 8.2. The tests with the same date or the same sample
identifier can be collected from the whole table, and the list can
be restricted to one test. The program only stores the month and
day of the measurement, when making a search it asks for the
Month and the Day separately. If you select the Sample ID
setting, the input screen of the sample identifier is displayed as
shown in figure 6.1.
By touching the Test button repeatedly you can select a built-in
test. The program gives a list of the tests suiting all the
conditions set in three lines of the main filter screen at the same
time.

Figure 8.2 Filter main menu

35
8.2 Detailed display
By selecting the “enlarge function” (magnifier) the detailed
description of the current test (with an orange background) can
be displayed as shown in figure 8.3. On the screen the times
before averaging (e.g. Raw1), the measurement channel number,
the possible error code are displayed, and it can be seen whether
the given test has been printed out or marked. When the window
is displayed, the function buttons at the bottom change, you can
delete tests by pressing the “dustbin” button, or you can print
out a given test by pressing the printer button. If you print from
here, you can start detailed printing as shown on the screen. You
can exit using the “minimize” button.

Figure 8.3 Detailed display

36
8.3 Action window
“Action” is the icon on the extreme right of the result display
(Figure 8.1). With this icon you can open the action window,
where the measurements can be printed out one by one or in a
group, or sent to an external computer, copied onto a USB
storage device or deleted. These actions can be performed on the
current measurements, marked measurements, all measurements
or on not printed measurements.

Figure 8.4 Action window

37
 9 Quality control
Quality of measurements can be ensured only by systematic
quality control procedure. Users have to measure and register
results of the dedicated control material. It is recommended to
use QC material delivered by Diagon or its distributors. If users
apply the instrument software regularly, it stores the results of
QC measurements, the measured data are able to be retrieved,
and processed.
The dedicated way of measuring QC samples is the QC menu,
results measured in QC menu are stored and processed
separately from patient results.

Figure 9.1. QC main menu

9.1 Setting target values of QC material

For setting parameters of QC material user should choose
„Settings” point in QC main menu, see fig. 9.1. Starting this
function the QC selection screen appears (fig. 9.2), the program
can store parameters of 8 QC material at the same time.

38
Figure 9.2. Control selection screen

When choosing a control material the Control definition menu

(fig.9.3.) appears and it is allowed to set target values for 4 tests
for each control material.

Figure 9.3. Control definition menu

When activating pushbutton with control name a virtual keypad

appears, where the name, the LOT code, and expiry date of
control material can be entered. Settings are saved by touching

39
 the OK button. Choosing each test the corresponding target
value definition screen appears (fig.9.4)
When touching the „Name” button repeatedly the abbreviated
names of tests appear one by one. When the desired name is
displayed, the minimum and maximum values of accepted range
of QC result can be entered. Besides the „Dimension” button
names of dimensions appears, which were defined in Settings
menu, in chapter 4. By pressing „Dimension” button the yellow
backgrounded current column can be chosen, and by touching
the „Minimum” and „Maximum” button the upper and lower
limit of acceptance range can be entered using virtual keypad.

Figure 9.4. Target value definition screen

9.2 Control measurements

When touching button „Measure” button in QC main menu the
test selection screen appears, same way as it is in measurements
of patient samples. After choosing test the QC measurement
screen appears, which is the same as the normal patient
measurement screen. After placing a cuvette to measuring
position in ID field a question mark appears. By touching the ID
field the previously defined QC material can be chosen from
control selection screen. The process of measurement is totally

40
 the same as process of patient sample measurement, but results
are stored in QC result database, which is accessible from
Results function of QC main menu.

9.3 Processing the control results

The chart of QC results is the same as chart of patient results,
and the menu functions for handling these data are the same,
except the filter function, see chapter 8. By activating the filter
function the special QC filter window opens (fig. 9.5).

Figure 9.5. QC filter screen

In default situation the three filter conditions are in „All” status,

so on the screen results of all tests measured in QC menu are
displayed. By touching „Sample ID” button the control selection
screen appears, and the necessary QC material can be chosen.
By pushing repeatedly the „Test” and „Dimension” buttons the
coherent measurements can be assigned. After accepted settings
the program collects all data of a specified control material, a
specified test, and a specified dimension of results, organized by
date and time of measurement. See the figure 9.6.

41
 Diagram
function

Figure 9.6. Chart of specific QC results

Activating „Diagram” function button the data of the specific

chart can be displayed in diagram format. The yellow crosses
represent the QC measurement, the line in the middle
corresponds to target value, the two dashed lines are the borders
of range of acceptance.

Figure 9.7. Diagram of QC measurements

42
 10 Maintenance

10.1 Changing printing paper

Warning!
Only printing paper supplied by the manufacturer can be used with the printer! The
use of any other type of paper may result in the early deterioration of the printer!
Open the cover of the printer by pressing the opening button.
Remove the remaining paper together with the paper cylinder.
Place the new reel in the nest so that its end points in the
direction of the screen. Pull the end of the reel about 5 cm above
the screen and close the cover!

10.2 Cleaning the measuring unit

Any reagent or sample falling on the measuring unit must be
removed immediately using paper towel dipped in water
containing a chemically neutral antiseptic washing agent, and
then it must be wiped dry. Contamination from the reagent
holding container must also be removed in this way.
For cleaning the measurement wells only cotton buds slightly
wetted with distilled water can be used. After cleaning and
before starting measuring the unit must be left to dry in heated
position for at least 10 minutes. The incubation positions can
also be cleaned with cotton buds wetted with water containing a
washing agent.
Warning!
The measuring unit may not be cleaned with a solution containing sodium
hypochlorite or any other caustic agent!

10.3 Cleaning the screen

The screen can be cleaned with a cleaning agent and towel
recommended for LCD screen specifically, available in
commercial distribution.

43
10.4 Cleaning the housing
The housing of the analyzer and power supply can be cleaned
after switching off and unplugging the device, using a towel
wetted with water containing a neutral washing agent.
Warning!
Removing the housing of the analyzer and the power supply may result in the failure
of the device or may cause an electric shock! Only skilled personnel may service the
device!

10.5 Action in case of malfunction

Error User action Call service if…
Controls out of range Checking if it is caused by Instrument failure
instrument reagent or method.
Inaccuracy, deviation Checking reproducibility with Light passes can be
between channels parallel measurements. contaminated
Abnormal start or stop Checking with standard (PT) Occurs with all assays
of measurement assay and normal sample
Frozen software Switch off and restart Repeated frozen
Temperature regulation Switch off. Call service
failure

Warning!
In the case of observed overheated block even if the displayed value is within the
acceptable range switch off the analyzer immediately! Failure to do this can cause the
damage of the instrument.

10.6 Scrap
Instrument scrapping must be performed according to the local
legal disposal of waste regulation.

44
Appendix A

Error Messages
D: Difference error: If the difference between parallel measurements is greater
than the permissible (Maximum difference).
C: Curve error: If there is a jump in the optical curve.
L: External light error: If it is too big a change in optical signal and the signal
out of the detection window.
T: Out of range error: If the measurement time is outside the measuring range
(Min time – Max time).
R: Calibration data error: If there is no calibration data in the calibration menu.
I: Incubation is too long: If the measurement does not start in time, because the
incubation time is too long.
O: Incubation was overheated: If the thermostated block is hot.
E: Expired lot: If the used reagent has expired.
R: Barcode type error: If the reagent type has changed (eg. Dia-PT ->Dia-PT
LIQUID), but the control range still belongs to the old reagent type.
Q: Out of QC: If the control result is out of control range.

45
 Appendix B

Use of Diagon screening, clotting test reagents in the Coag4D

PT test APTT test Fibrinogen test TT test
Reagent Dia-PT Dia-CaCl2 Dia-FIB Dia-TT
incubation at 37°C at 37°C at room at room
temperature temperature
Sample Plasma/control
preparation 1:10 dilution
with Dia-
Imidazol
Sample dosing 50μl plasma/ 50μl plasma/ 100μl prepared 100μl plasma/
control control + sample control
50μl Dia-PTT
Incubation 2 minutes 3 minutes 2 minutes 2 minutes
Start reagent 100μl Dia-PT 50μl Dia-CaCl2 50μl Dia-FIB 100μl Dia-TT

Use of Diagon turbidimetric and chromogenic reagents in the Coag4D

D-dimer test ATIII test
Reagent Dia-D-DIMER Dia-ATIII
incubation at room FIIa Substrate
temperature at 37°C
Sample Plasma/control
preparation 1:20 dilution
with Dia-ATIII
FIIa Diluent
Sample dosing 20μl plasma/ 50μl prepared
control + sample +
115μl Dia-Ddi 50 μl Dia-
Buffer ATIII FIIa
Incubation 2 minutes 2 minutes
Start reagent 45μl Dia-Ddi 50μl Dia-ATIII
Latex (mixing FIIa Substrate
with pipette)
Reading time 20-150s 10-40s

See also the reagent package insert for details.

46
Appendix C

Menu structure
Coag4D Manual
Software

Measurement Calibration QC Setup Results System

Language
Test categories Date ID Test Sec Ratio % INR G/L
0501 111 PT 12,5 1,0 100 1,00 -
0401 101 Fib 6,5 2,5

Date/time
User defined
Screening tests Factors Inhibitors D-dimer ATIII tests
Format

Date
PT II, V, VII, X APC

Time

APTT VIII, IX, XI, XII Protein C

Settings

Sound
Fibrinogen Protein S

Mixer

Printer
TT LA

Measure
Setup
Setup Turbidimetry
Measurement Calibration QC Identification
Clotting Chromogenic - SN
- ID
Speed
Reagent Min. time First time - Normal
ID ... sec Lot Nr Measure - Quick
Expiry date
Max. time Second time
Ratio
Mean Normal
Error
ID ... sec
value Min. time Reagent nr. messages

%
-Calibrator lot Nr Lag time Incubation time
-Curve type
-Values Result
Reagent nr. Dimension
INR
-ISI
-Calibrator lot Nr Incubation time
-Values
G/L Settings
-Calibrator lot Nr Algorithm
-Curve type
-Values -Lot Nr
-Levels Dimension
µgFEU/mL -Dimension
-Calibrator lot Nr -Ranges
-Curve type Parallel
-Values
Barcode
Barcode Date Level % Range Note Mean CV
0501 1 105 85-115 in 115 12,3
0401 1 125 85-115 out

47
Appendix D

Symbols used on the instruments and accessories

CE conformity

Consult instruction for use

In vitro diagnostic device

“New” waste

Caution, consult accompanying documents

Fragile, handle with care

Keep dry

This way up

Allowed storage/shipping temperature range

Allowed storage/shipping humidity range

Catalogue number

Serial number

Manufacturer

Warning, biological hazards

Non-sterile

Do not reuse

Contains suficient for <n> tests

Batch code

48