Manual de Uso Clot2S

USERS MANUAL
Software ver. 1.1
CLOT 2S Users manual
USERS MANUAL
Software ver. 1.1
SEAC S.R.L.
Via di Prato, 72/74 - Calenzano - Firenze
Tel:(055) 8877469 - Fax:(055) 8877771
Cod. 53872211
INDEX
1.
GENERAL DESCRIPTION ....................................................................................... 11

1.1. Foreword................................................................................................................ 11
1.2. Technical features.................................................................................................. 12
1.3. Operating principle................................................................................................. 14
1.4. Description of devices............................................................................................ 16
1.5. Host computer connection ..................................................................................... 21
1.6. Precautions and limitations .................................................................................... 23
1.6.1. Intended use .................................................................................................... 23
1.6.2. Performance .................................................................................................... 23
1.6.3. Protection......................................................................................................... 23
2.
INSTALLATION AND PRELIMINARY OPERATIONS............................................. 24

2.1. Foreword................................................................................................................ 24
2.2. Transport, storage and unpacking ......................................................................... 24
2.2.1. Composition of the supply................................................................................ 25
2.3. Device installation .................................................................................................. 26
2.3.1. Preliminary operations ..................................................................................... 27
3.
USE .......................................................................................................................... 28
3.1. Start-up ..................................................................................................................28
3.2. Main menu ............................................................................................................. 28
3.3. Testing ...................................................................................................................29
3.3.1. Test selection................................................................................................... 29
3.3.2. Calibration........................................................................................................ 29
3.3.3. Determinations................................................................................................. 33
3.3.4. Results ............................................................................................................. 34
3.4. Test programming.................................................................................................. 35

3.4.1. Edit test ............................................................................................................ 36
3.4.2. Copy test.......................................................................................................... 39
3.4.3. Delete test........................................................................................................ 39
3.5. Utilities ................................................................................................................... 40
3.5.1. Photometer calib. ............................................................................................. 40
3.5.2. Settings ............................................................................................................ 40
3.6. Aggregation rec. (aggregation recording) .............................................................. 41
3.6.1. Principle of the method .................................................................................... 41
3.6.2. Preparing the samples ..................................................................................... 41
3.6.3. Preparation of the work solutions..................................................................... 42
3.6.4. Performing the test........................................................................................... 43
3.6.5. Interpreting the results ..................................................................................... 45
3.6.6. Aggregation curves .......................................................................................... 46
3.6.7. Practical advise for assessing the aggregometric plots ................................... 49
3.7. Test........................................................................................................................ 49
3.7.1. Management of samples.................................................................................. 49
3.7.2. Test programming............................................................................................ 50
3.7.3. Prothrombin time (PT)...................................................................................... 51
3.7.4. Activated partial thromboplastin time (APTT)................................................... 53
3.7.5. Fibrinogen assay.............................................................................................. 54
3.7.6. thrOmbin time (TT)........................................................................................... 55
4.
MAINENANCE AND TYPES OF FAULTS ............................................................... 57

4.1. Maintenance .......................................................................................................... 57
4.1.1. External cleaning of the instrument.................................................................. 57
4.1.2. Cleaning of the reading cell.............................................................................. 57
4.1.3. Printer paper replacement ............................................................................... 58
4.2. Types of faults ....................................................................................................... 60
INDEX OF FIGURES
Figure 1.1 - Main layout ................................................................................................... 15

Figure 1.2 - Front view ..................................................................................................... 16
Figure 1.3 - Alphanumeric keyboard ................................................................................ 18
Figure 1.4 - Back Panel ................................................................................................... 20
Figure 4.1 - Print paper replacement ............................................................................... 59
WE VALUE YOUR OPINION

Reference:
CLOT 2S COAGULOMETER Users Manual Code 53872211
Your suggestions, advice and criticisms would be very welcome and useful for improving our
product. We would, therefore, be grateful if you could answer the following questions:
-
Have you found this manual easy to understand and follow? Please, indicate your
impressions:
....................................................................................................................................................
....................................................................................................................................................
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-
Have you found any errors in the instructions? If so, please indicate the paragraph and
page:
....................................................................................................................................................
....................................................................................................................................................
....................................................................................................................................................
....................................................................................................................................................
....................................................................................................................................................
....................................................................................................................................................
....................................................................................................................................................
COMPANY NAME .......
NAME AND SURNAME ................
ADDRESS .
TELEPHONE .................................................................... DATE ..............................................
Please, return this form to:
SEAC S.R.L. - Via di Prato, 72/74 - 50041 Calenzano (FI).
Tel 055/8877469 Fax 055/887771
Thank you for your cooperation.
7
I. STATEMENT OF LIABILITY
Our Company declines all responsibility for damage due to any type of modifications made on
the Hardware or Software and for damage due to connection with other instruments not
carried out by our personnel or previously authorized.
In the event of the device being damaged, do not switch it on until it has been repaired by our
personnel.
All operations of an electrical nature required for installing or repairing the instrument must be
carried out by our personnel; avoid all other types of installation.
The instrument must be installed in a suitable environment, as described at points II and III of
this chapter, so as to censure that its performance complies with the values given in the
technical specifications.
Use the instrument only after reading this manual.
II. SAFETY PRECAUTIONS

This instrument has been designed and tested in accordance with CEI EN 61010-1 CLASS 1,
INSTALLATION CATEGORY II - Electromagnetic Compatibility.
The CLOT 2S coagulometer ensures maximum safety conditions for the operator during use.
However, the dangerous voltage used by the device internally requires that the operator
follow these general safety rules:
Make sure that power is supplies at the required voltage before switching the instrument
on.
The instrument must have a ground connection. Should a line short circuit occur, ground
connection will eliminate the risk for the external metal parts of the tool to be powered at
the voltage supplied.
In the event of over-absorption (due to a short circuit or another malfunction within the
instrument or due to sudden line voltage variation), the protection fuse located on the
back will be operated; in this case, if the new fuse burns out again after having replaced it
with another of the same kind, disconnect the instrument and contact the Technical
Support staff.
Do not use the commands or adjustments inside the instrument and notify the service
staff as soon as any anomaly occurs during operation.
Before starting any type of action inside the device, switch it off (move the power button
onto O) and disconnect the power cord. To do this, grab the plug but never pull the
cable directly.
Refer all repair operations to Technical Support staff.
Refer all installation operations that involve powered parts to specifically qualified staff.
If the device is damaged, do not start it until it has been repaired by a qualified member of
the Technical Support Service.
Disconnect the device if you are not going to use it for long periods of time.
III. TECHNICAL FEATURES AND CIRCUIT TRANSIENTS

Circuit transients may be caused by many different factors, such as:
- Starting and stopping of electric motors
- Weather conditions
- Connection and disconnection of great line loads.
We must stress that serious circuit transients may negatively affect the system.
An efficient ground connection is necessary to reduce circuit transients and ensure maximum
safety for the operator.
Distribution
1 phase, neutral and ground
Power Supply
115 / 230 VAC

50 - 60 Hz
Power Requirement
83 VA
Line Fuse
T 1A L
TABLE OF SYMBOLS
Number
Symbol
Description
Alternating current
Ground terminal
On (power)
Off (power)
Fuse
Caution: risk of electric shock
Caution: see attached documentation
Caution: biological risk
EC mark
10
1.
GENERAL DESCRIPTION
1.1.
FOREWORD
The device CLOT 2S is a semi-automatic coagulometer designed to test coagulation

according to the following criteria:
The device can carry out the following tests: PT, APTT, Fibrinogen, TT, Coagulation
Factors and tests showing clot forming.
The device is provided with two independent reading channels with a magnetic agitator
and a thermostat compartment for sample and reagent incubation.
It allows for four different standard calibrations, and calibration curves can be stored in
the memory and printed.
When the reagent/plasma (starter) is dispensed, the device automatically starts the
count and stops it when the clot is formed.
Results are shown on the liquid crystal display and printed on the thermal matrix printer.
Results can be expressed in different measurement units.
Connection to a Host Computer through RS232.
The device can be set to record the platelet aggregation plot.
11
1.2.
TECHNICAL FEATURES
Measurement principle
Photometry
Light source
950 nm LED
Reading channels
Determinations
PT, APTT, TT, Fibrinogen, Coagulation Factors and clot

forming tests.
Final work volume
= 300 L (reagent + plasma)
Repeatibility
PT
Fibrinogen
C.V. = 1,8%
C.V. = 2,6%
C.V. calculated on a group of 8 readings of normal

plasma.
Agitation
Magnetic agitation, by means of a metal armature.
Thermostat
Dry heated block.
Number of positions
30, for sample incubation; 2, for reagent vials; 2, for

measurement channels.
Incubation
37C 1C
Heating time: from 25 to 37C less than 15 minutes
Keyboard
15 keys for programming and device control; 4 keys for

measurement control; 2 keys for printer control.
Display
Alphanumeric liquid crystal display, with 4 20-character

lines.
Printer
Graphic printer with

thermographic paper.
Host connection
RS232
192
points
per
line,
for
12
General features
Power supply
115 / 230 VAC

50 - 60 Hz
Power Requirement
83 VA
Line Fuse
T 1A L
Operating Conditions
Temperature
15 32C (during operation)

0 50C (when off)
Relative Humidity
20 80 % (during operation)
0 90 % (when off)
Altitude
< 2000 m (during operation)
Environmental coefficient :
Safety
Electromagnetic Compatibility EUROPEAN DIRECTIVE

EEC 73/23
STANDARDS: CEI-EN 61010-1, CLASS I,
INSTALLATION CATEGORY II
Electromagnetic
Compatibility
EUROPEAN DIRECTIVE on Electromagnetic

Compatibility EEC 89/336
Dimensions
30 x 30 x 36 (h) cm
Weight
8 Kg
13
1.3.
OPERATING PRINCIPLE
Figure 1.1 shows the diagram of the operating principle of the coagulometer, which can be
detailed as follows:
Reading cell, including the photodetector (3), the photometer (9) and the test tube (1)
introduced by the operator, which contains the sample to be tested.
Magnetic capitan agitator, including a motor (5), a magnet (4) and the armature (2) that
is placed in the test tube and moved by magnetic drive.
The computer (8) processing all the data.
Device operation can be summarized as follows:

The photodetector (3) receives light from the photometer (9) through the test tube (1)
containing the sample to be tested.
When the reagent/plasma (starter) is dispensed, a variation occurs in the light transmitted and
is measured by the photodetector (3).
This variation causes the computer (8) to start counting the time and turn on the small engine
(5) which rotates the armature (2) by means of the magnet (4) to maintain the sample being
tested homogeneous.
When the clot is formed, the photodetector (3) detects a variation in the light transmitted and
the computer (8) stops the time count and the motor (5).
The results are then showed on the display (6) and printed (7).
14
Figure 1.1 - Main layout
15
1.4.
DESCRIPTION OF DEVICES
The figure below shows a front view of the device.
Figure 1.2 - Front view
16
Thermostat
The thermostat compartment includes:
30 positions for sample incubation (3)
2 positions for reagent (2)
2 independent reading positions with a magnetic agitator (1)
Printer
The graphic printer can be used to print the following data:
the results expressed in the preset measurement units
test parameters
calibration curves
system settings
Alphanumeric 80-character display (4 lines x 20 characters)

The following types of messages can be shown on the display
results of the reading in the preset unit of measurement
request for test parameters
request for the system settings
error messages
17
Keyboard
It has 9 alphanumeric keys (1 9) and the following keys: CL, O/No, ./Yes, reset1, reset2,
timer1, timer2, print, feed, enter, stop.
Figure 1.3 - Alphanumeric keyboard

Alphanumeric keys
The 9 alphanumeric keys, the 0/No and ./Yes keys are enabled upon entering alphabet
characters only during the steps of the programme that require entering the test name. If you
press an alphanumeric key during this stage, you can select the following characters:
Ex. 1 ABC key
first pressing : 1
second pressing
third pressing
fourth pressing
fifth pressing : a
sixth pressing
seventh pressing
eighth pressing
and so on.
:A
:B
:C
:b
:c
:1
If you press /Yes, you can obtain the types
(space), +, /,
18
Keys
Function
:
Cancels Last type pressing (preset parameter), provided that you have
not pressed Enter before.
It has a . function if you are entering a number or a yes function if you

are answering a yes/no question.
0/No
It has a 0 function if you are entering a number or a no function if you

are answering a yes/no question.
Reset1
If pressed during a test execution, when counting is ongoing, it manually

stops the reading.
If pressed during a test execution, when counting is not going, it zero
sets photometrically the reading channel.
If pressed during platelet aggregation plot recording, it controls PPP and
PRP reading.
Reset2
It has the same functions of reset1 but for reading channel 2.
Timer1
It enables and disables the timer of channel 1 used for the incubation
time preset for the test selected.
Timer2
It has the same functions of timer1 but for reading channel 2.
Print
If pressed after printing the results of a test, it provides a new print. If

pressed during programming or execution of a test, it shows more
information pages (i.e. measurement units lists).
If this key is held down for one second, you can disable and re-enable
the printer (Print on/off).
Feed
Paper feeding
Enter
If pressed at the end of a calibration reading, it accepts the

measurement. If pressed after an error has been notified, it cancels the
error and recovers device operation.
If pressed at the end of the recording of a platelet aggregation plot, it
accepts this recording and resets the device ready for a new recording.
Stop
It stops the ongoing operation. The device goes back to the previous
menu.
If pressed during the recording of a platelet aggregation plot, it stops the
recording.
CL
/Yes
19
Back panel
Figure 1.4 - Back Panel
Voltage switch (115 / 230 VAC)
Power supply outlet and device switch.

Press I to turn on and 0 to turn off.
Female 9-pin tray connector for Host Computer connection.

Data are transferred by means of an RS232 serial interface.
The equipment connected to the serial interface (3) must be

compliant with EN60950 standards.
20
1.5.
HOST COMPUTER CONNECTION
Data are transferred at the end of each measurement.

The serial interface connector for connection with the host computer is available on the back
panel of the device.
Features of the Host Computer connector
The signals on the female DB 9-pole connector of the device are:
Pin
description
I/O
2
Transmit data (TXD)
Output
3
Receive Data (RXD)
Input
5
Signal Ground
Features of the connection cable
The device must be connected with the host computer with an RS232 cable with the following
features:
Host computer with 25-pole serial interface connector
DB pin male 9-pin connector
DB pin female 25-pin connector
CLOT 2S
Host computer
3-Receive Data (RXD)
2-Transmit data (TXD)
5-Signal Ground
7-Signal Ground
Host computer with 9-pole serial interface connector

DB pin male 9-pin connector
DB pin female 9-pin connector
CLOT 2S
Host Computer
2-Transmit Data (TXD)
5-Signal Ground
5-Signal Ground
Transmission features
Transmission format
Baud rate = Programmable
Data Bits = 8
21
Stop Bits
Parity
= 1
= None
The CLOT 2S sends the data to the Host Computer in XML 1.0. format. The transmission
software uses the set of ASCII characters standard . The data transmission is carried out at
the end of each measurement.
Dati
Int
Uint
float
Date
string
Description
Integer with sign
Integer without sign
Number in floating point
date expressed in the DD/MM/YY format
Sequence of ASCII characters
TAG
Description
<CLOT2S>...</CLOT2S>
<TEST>...</TEST>
<CALIB>...</CALIB>
<STD>...</STD>
<SMP>...</SMP>
<ID> Uint </ID>
<NAME>string</NAME>
<DATE>date</DATE>
<CHANNEL> Uint </CHANNEL>
<CNT> Uint </CNT>
<IDSTRING>string</IDSTRING>
<TIME>float</TIME>
<RATIO>float</RATIO>
<INR>float</INR>
<ACTIVITY>float</ACTIVITY>
<CONC>float</CONC>
<UNIT>string</UNIT>
<OVERSTD>
<UNDERSTD>
Aggregates a measurement session

Aggregates a test
Aggregates the calibration phase
Aggregates a standard calibration
Aggregates the results of a sample
Progressive ID
Contains the name of the test
Contains the date set
Reading channel
Progressive readings
Patients ID
Time always expressed in seconds
Ratio
INR
Activity
Concentration
Measuring unit of the concentration/activity
Concentration/activity is higher than last std
Concentration/activity is lower than the first std
22
1.6.
PRECAUTIONS AND LIMITATIONS

1.6.1. INTENDED USE
The device CLOT 2S is a semi-automatic coagulometer designed to carry out coagulation

tests.
1.6.2. PERFORMANCE
The CLOT 2S can be programmed to carry out a wide range of different tests. The
performance of the system may vary according to the parameters set by the user.
It is the responsibility of the user to ensure compliance with the requirements of each
individual assays manufacturer.
1.6.3. PROTECTION
Electronic components may cause electric shock and injury. Do not remove
covers or doors if not specifically recommended in this manual.
The use of clinical samples involves an important biological risk and must
therefore be carried out with the utmost caution.
The instrument is designed to censure maximum protection of the user during
normal operation.
23
2.
INSTALLATION AND PRELIMINARY OPERATIONS
2.1.
FOREWORD
The instrument must be supplied with 115 / 230 VAC and 50 60 Hz voltage.
Make sure that the voltage selected corresponds to the mains voltage by using the
voltage switch located on the back panel.
2.2.
TRANSPORT, STORAGE AND UNPACKING
There are certain precautions to keep in mind during transportation, storage and unpacking of
the instrument in order to avoid damages also due to storage in an improper environment.
TRANSPORTATION
The instrument weighs about 10 kg when packed, 8 kg when not packed; its size is 48 x 42 x
43 (h) cm with the packaging, 30 x 30 x 36 (h) without packaging.
Therefore, no special equipment is needed for transportation, loading and unloading of the
device box.
The box should be handled in compliance with the recommendations indicated on the outer
surface (UP-DOWN).
STORAGE
The equipment should be stored in its original packaging, consisting in a box, and according
to the specific recommendations written on the outer side (UP-DOWN).
If the packaging has been damaged during storage or transportation, first check that the
device has not been clearly damaged: if so, restore the packaging before storage.
24
If the packaging appears to have been damaged, call the Supplier.

The packaging ensures reliable protection and insulation if the box is deposited in safe and
suitable environments. The storage room must be dry and free from dust.
UNPACKING
Unpacking operations are very simple: Unpack the device with care; Do not throw the
packaging, as the device might need to be shipped again in the future; Remove the device
from the packaging keeping it in a vertical position;
2.2.1. COMPOSITION OF THE SUPPLY

Unpack the device. The device comes with the following accessories:
Q.ty
Description
Code
Power supply cable
29800410
T 1A L fuse
29000021
Paper rolls for printer
Kit of 100 cuvettes + armatures
72040350
Users Manual
53872211
Plastic cover
52040510
72040022/10
25
2.3.
DEVICE INSTALLATION
Operative requirements are the priority in the selection of the room/environment where the
device should be installed. The overall dimensions of the coagulometer are 30 x 30 x 36 (h)
cm, but sufficient space should be left all around the device to facilitate access for
maintenance operations.
The primary activities needed to install the device are:
Identification of a person in charge of installation procedures and contacts with the

supplier for any clarification.
Selection of the environment where installation shall take place.
Purchase of any accessories (cuvettes, paper, etc.) in addition to those supplied with the
device.
Although the coagulometer has been designed with such components as to ensure safe
operation even in unfavorable conditions, check that the installation environment has the best
possible conditions to favour the most reliable performance.
High temperatures speed up the ageing process of components, and may cause
temporary or even permanent changes to them.
A particular dusty environment may cause an abrasive action on the components and
therefore reduce their life.
Vibrations may cause errors in the measurements taken by the device.
High frequency and high intensity pulses generated in the electric lines or induced by the
surrounding environment may cause measurement errors.
Do not install the instrument near any heat source such as radiators, hot air pipes or
places directly exposed to sun light.
Avoid rooms where sudden temperature changes may occur.
The installation room must be provided with a power supply outlet with the following
characteristics:
26
Distribution
: 1 phase, neutral and ground
Power Supply
: 115 / 230 VAC

50 - 60 Hz
Power Requirement
: 83 VA
A 3-wire cable with a 3-contact outlet is supplied together with the device for connection to the
mains and grounding system. Never connect the instrument to an ungrounded outlet.
A grounding system non built according to workmanlike standards may imply dangers for the
operator.
Environmental characteristics of the installation room
Temperature
: 15 32C (during operation)

0 50C (off)
Relative Humidity
: 20 80 % (on)
0 90 % (off)
Altitude
: < 2000 m (on)
2.3.1. PRELIMINARY OPERATIONS

Turning the device on
Turn the device on by using the ON/OFF switch located on the back panel.
Thermostat setting
Before carrying out any testing, the coagulometer must be taken to the operative temperature
of 37C indicated in the display (required time: about 15 minutes from 25 to 37C).
Paper feeding
Before starting any operation, feed the paper in the printer as described in 4.1.3.
27
3.
USE
3.1.
START-UP
Turn the device on by using the ON/OFF switch located on the back panel. The device will
carry out a number of checks and inform the user of any anomaly. At the end of start-up you
will be requested to enter the current date. Enter 2-digit day, month and year and then press
enter. If you press enter without entering the date, the date will not be printed on the analyzer
report and the main menu will be displayed. Before any reading, wait unit the thermostat has
reached the temperature of 37C: this means that from a room temperature of 25C, you will
wait for about 15 minutes.
3.2.
MAIN MENU
The main menu shows the four basic functions of the device.
1 :
T e s t
2 :
P r o g r a m m i n g
3 :
U t
4 :
A g g r e g a t
e x e c u t i
o n
i e s
i o n
r e c .
You can choose the function desired by selecting 1, 2, 3 or 4. The general features of each
function are:
1: Testing
When you select this function, the device carried out the measurements according to the
parameters preset during programming (paragraph 3.4.1).
2. Programming
This function allows a new test to be carried out or a stored test to be changed or cancelled.
The device has a memory capacity of 99 tests (ID from 1 to 99), which are programmed by
the operator when answering the computers questions. The data entered are checked at
each answer provided. At the end of programming, you can obtain a print of the test entered
by simply pressing Print.
28
3. Utilities
Use this function by selecting Photomer Calib. to check the amplitude (Volt) of the
photometric signal of the two reading channels. Select Settings to check and set the general
device options (paragraph 3.5.2).
4. Platelet aggregation recorder
This function allows the device to record the platelet aggregation plot.
3.3.
TESTING
3.3.1. TEST SELECTION
From the main menu, press (1) and you will be required to enter the code number of the test
to be carried out, through the display of the following message:
Press PRINT for list
Test?
Press print to obtain a list of programmed tests.

If you enter the ID number of a test, that test will be carried out and
displayed.
PRINT for parameters

ENTER for execution
Press print to obtain a print of the parameters of the test selected.

By pressing enter when the thermostat is at temperature, you can
calibrate the device (par. 3.3.2) or do determinations (par. 3.3.3),
otherwise you have the display only.
Wait until the temperature is reached before you start measuring.

Please Wait
Operating temperature Press enter to pass to the next operation without waiting.
(Target: 37C)
3.3.2. CALIBRATION
Calibration is required only for those tests where standards need to be read to determine
results.
The number of readings depends on test settings (number of standards, number of
repetitions). The device will require the standards in sequence, starting from the less STD1
concentrated one.
29
In the tests whose results are expressed in Ratio and INR, the device will require only one
reference plasma.
Note: Determinations cannot be done on two channels simultaneously during calibration;
however, we recommend doing determinations using the two channels alternately.
If no calibration is stored in the memory, the device will show:
Error
Curve not defined
Press Enter
The device tells you that you have to do calibration.

Press Enter to pass to calibration.
If calibration is stored in the memory, the device will show:

Print for curve
Calibration Y/N
Press Print to print calibration parameters.

Press No to pass to determinations (par. 3.3.3) without calibrating.
Press Yes to pass to calibration and view per example:
3 7 C
N e x t
S T D 1
R E P 1
C H 1
s e c
C H 2
s e c
The generic procedure for standard execution is:
Prepare the standards with the concentrations entered in the test;
Apply the generic procedure to execute the standards as described in paragraph 3.3.3.
In this case, if you press reset1 the device will be prepared for clotting time determination for
the standard1 (S1) first replication (R1) in channel1 (CH1).
30
3 7 C
N e x t
S 1
S T D 1
R E P 1
C H 1
0 . 0
R 1
C H 2
s e c
s e c
After each reading, if you press enter the result will be stored and you can pass to read the
second replication of the standard. If the result obtained does not correspond to the expected
result, press reset to repeat the reading without storing the result. For each standard the
average of replications is printed and, at the end of determinations, the calibration curve is
printed.
In the event of a monotonic curve, the following will appear in the display:
Save curve [Y/N]
Press Yes to save the data stored.

If you press No when a curve is stored in the memory, you go back
to the Fitting Curve menu, otherwise you have the display.
Error
Non-monotonic curve
Press ENTER
Press enter to return to the previous request.
In the event of a non-monotonic curve, the following will appear in the display:
Error
Non-monotonic curve
Press ENTER
F i
i n g
By pressing enter, the following will be displayed:
c u r v e
1 :
U s e
o l d
2 :
R e c a l
3 :
M a n u a l
3 7 C
c u r v e
i b r a t e
c a l
i b .
1: Use old curve

if the curve is there, the stored curve is printed and the following is displayed:
Save curve [Y/N]
Press Yes to execute the readings.

Press No to return to the Fitting Curve menu.
31
If there is no curve, the following is displayed:

Error
Curve not defined
Press Enter
Press Enter to return to the Fitting Curve menu.
2: Recalibrate
If there is a curve, the following is displayed:
Print for curve
Calibrate Y/N
Press Print to print the curve stored in the memory.

Press Yes to execute the standards.
Press No to execute the readings.
If there is no curve, pass to execute the standards.
3: Manual calib.
The following message will be displayed:
Edit time for standards
[y/N]
You can press Yes to correct the points of the calibration curve.
The device will present the times of the standards in sequence,
starting from the less STD1 concentrated one.
If you enter a monotonic curve, the following is displayed:
Save curve Y/N
Press Yes to execute the readings.
If you press No, you return to the Fitting Curve menu.
If you enter a non-monotonic curve, the following is displayed:
Non-monotonic error curve, press Enter.
If you press Enter, you return to the Fitting Curve menu.
Press No to return to the Fitting Curve menu.
32
3.3.3. DETERMINATIONS
The device allows for two simultaneous readings on the two reading channels (CH1 and
CH2). The device is provided with two timers preset based on test programming to check the
incubation time. At the end of the measurement the result, including the serial number and ID,
are displayed and printed, if requested.
The following is displayed in reading execution:
3 7 C
T i m e
C H 1
s e c
C H 2
s e c
The generic procedure for standard execution is:
to arrange the cuvettes with armature in thermostat setting to be heated in the positions
for reagent/plasma incubation.
Dispense the amount of reagent/plasma required for the test.
Incubate the reagent/plasma for the preset time according to the type of test by activating
timer1 or timer2. When the times is active, a flashing T1 or T2 message is displayed.
When the incubation time is over, the T1 or T2 message stops flashing and a continuous
beep is emitted.
Introduce the cuvette to be tested into the selected reading channel and press reset1 and
reset2 to zero set the photometric channel. The display will show, for example:
P T
3 7 C
T i m e
C H 1
C H 2
0 . 0
s e c
s e c
33
Zero setting is marked by the value 0.0, which also indicates that the device is ready to
detect reagent/plasma dispensing (starter) to start the count.
When the reagent/plasma is dispensed into the test tube being read, the device
automatically starts the count of the clotting time and the agitator.
As soon as the clot is formed, the count and the agitator are automatically stopped, and
the results can be viewed and printed. In addition to the results, the serial reading number
is viewed on the left of the measurement channel (CH1).
If the device has been preset accordingly, the data are sent to the host computer, as
described in paragraph 1.5.
3.3.4. RESULTS
Readings can be expressed in different measurement units simultaneously. The device will
measure the coagulation time (sec.) and calculate the other parameters. Parameters are
calculated by calibrating the device against a standard or a reference plasma (Ratio, INR) or
more standards by means of a calibration curve (Act%, mg/dL, g/L, IU/L).
At the end of each reading, the result is displayed in the measurement unit selected, which
has been preset in the Edit test function (par. 3.4.1). The print will show the reading
expressed in all the measurement units programmed in the test.
Calculated parameters
The readings expressed in seconds depend on the reagent batch, the device and the
techniques used. The results obtained by different laboratories may differ considerably.
In order to reduce these differences, the result is best expressed in Ratio, by referring the
coagulation time of the sample to the coagulation time of a standard 100% plasma or normal
plasma, by using the following equation:
Ratio =
tempo campione
tempo plasma standard
The Ratio is calculated by using the standard or the reference plasma with 100% activity.
34
In order to make results independent from the type of reagent used, the result is expressed in
INR (International Normalized Ratio), by using the ISI (International Sensitivity Index) value,
with the following formula:
tempo campione
INR =
tempo plasma standard
ISI
This parameter is used in the PT test.

In order to calculate the results expressed in Act%, mg/dL, g/L, IU/L, you have to build a
calibration curve. The instrument will calibrate with 3 or 4 concentration levels and up to 4
replications.
As an alternative, the results expressed in Ratio, INR, Act% and concentration may be
determined by using the conversion table container in the reagent kits.
Sample identification
The readings are identified with a serial 3-digit number that is 1 upon default turning on, but
can be entered with any other number (par. 3.5.2).
Each reading channel has its own serial number, so there is a reading 1 of channel 1 and
reading 1 of channel 2. If programmed, the samples (par. 3.5.2) can be identified with 8
alphanumeric characters that must be entered before each reading.
3.4.
TEST PROGRAMMING
From the main menu, press 2 will be displayed 3 programming functions:

P r o g r a m m i n g
1 :
E d i
t e s t
2 :
C o p y
t e s t
3 :
D e l e t e
3 7 C
t e s t
You can choose the function desired by selecting 1, 2, or 3.
35
3.4.1. EDIT TEST

The program presents a number of questions to which the user must answer to enter test
parameters. During test programming, you can set that the result be expressed in multiple
measurement units simultaneously. This selection will determine the number and sequence of
the parameters to be entered.
The table below lists the parameters to be entered:
Test
Test
Test
%Act., g/L, mg/dL

IU/mL
Test
Test name
Test name
Test name
Test name
Incubation time
Incubation time
Incubation time
Incubation time
Units
Units
Units
Units
Units to display
(for more than 1
unit)
Units to display
(for more than 1 unit)
Units to display
Units to display
Sec.
Ratio
INR
Nr. of standards
STDn. conc.
Repeat standards
Edit time for standards Edit time for standards
STDn. Time
STDn. Time
Edit time for standards

STDn. Time
High Limit
Low Limit
Scale
ISI
Autoprint
Autoprint
Autoprint
Autoprint
Save method
Save method
Save method
Save method
36
Below are shown the parameters required:

Press PRINT for list
Test?
Numeric from 1 to 99. If you enter the code of a test that has
already been entered, you can change test parameters. If you press
Print in this stage, you can obtain a print of the tests stored.
Test name
Alphanumeric max 15 characters. During the request for this

information, the first of the 15 available spaces will be flashing. Use
the numeric keys to digit the name of the test. Each key
corresponds to a number and three letters (i.e. 2-DEF ; 3-GHI,
ETC.). To digit, for example, letter I, you need to press 4 times the
numeric key 3, and so on. When the reading has been chosen,
confirm by pressing Enter and the subsequent space will flash.
Each time you press CL (Clear) you cancel the last letter entered.
By pressing Enter, the set name is confirmed.
Valid rng:0-60 min

Incubation time?
Numeric from 0 to 60. Digit the number of minutes of incubation

required by the test to be carried out. Press Enter to confirm.
Print: next pg
1: sec
2: Ratio
3: INR
Units?
Press Print to view the other measurement units, which are:

4: %Act., 5: mg/dL, 6: g/L, 7: IU/mL
You can select one or more measurement units.
To select a measurement unit, digit the corresponding number.
To select multiple measurement units, digit the corresponding
number separated by a point (i.e. to select sec and Ratio, digit 1.2).
Note: To express the result in INR, select Ratio as well.
Valid data
Unit to display
To select the measurement unit to be displayed.

If you want to select multiple measurement units, you can choose
which measurement unit should be viewed in the display and which
should not, even though they can be printed.
To select multiple measurement units, digit the corresponding
numbers.
Valid rng: 3-4

Nr. of standards?
To select the number of standards. You can calibrate with multiple

standards. So, you have STDn. Conc.? With n. from 1 to the set
number. For each question, enter the concentration of the
corresponding standard.
Note: STD concentrations must be shown in increasing orders. If
an error occurs, the question is asked again.
37
Valid rng: 1-4

Repeat standards?
To select standard replications. Digit the number of determinations

you intend to execute for each standard.
Edit time for

standards [y/N]
Press yes to enter the coagulation time corresponding to each

standard. So, you have STDn sec.? With n. from 1 to the set
number. For each question, enter the coagulation time of the
corresponding standard.
Note: The coagulation times regarding each STD must be shown
in decreasing order. In caso di errore viene riproposta la
domanda.
Press Yes to execute the determination of the coagulation time for
each standard (par. 3.3.2).
Valid rng: 0-999

High Limit?
Digit the value of the maximum concentration you intend to

determine. If this is not specified, it is entered with the same value
as the highest standard.
Valid rng: 0-999

Low Limit?
Digit the value of the minimum concentration you intend to

determine. If this is not specified, it is entered with the same value
as the lowest standard.
1: Lin-Lin
2: Log-Log
Scale?
Press 1 to select the print of the calibration curve on a linear scale.

Press 2 to select the print of the calibration curve on a logarithmic
scale.
ISI
Digit the value of the International Sensitivity Index (ISI) used for
INR determination.
Autoprint [Y/n]
If you press Yes, you will set the automatic print of results at the
end of the reading.
Save Method [Y/n]
Press yes to store the test in the memory and return to the
Programming menu. In the event of an already programmed test,
this question will be asked only if at least one change has been
made.
38
3.4.2. COPY TEST

This function allows copying an already programmed test into a new position.
The display will show:
C o p y
t e s t
S e l e c t
P r e s s
T e s t
t e s t
P R I N T
3 7 C
t o
f o r
c o p y
l
i s t
Press Print to print all the tests stored.

If you enter a number, you can select the test to be copied; if a blank position has been
recalled, the question is repeated. Press enter to view the following:
P T
3 7 C
S e l e c t
P r e s s
T e s t
d e s t
i n a t
P R I N T
f o r
i o n
l
i s t

Enter a number to select the position where you intend to store the test to be copied.
The name of the test to be copied will be displayed.
If the position recalled is already occupied, the Enter to overwrite message will be displayed.
(Enter to overwrite). Press enter to execute the operation. Press Stop to cancel the
operation.
3.4.3. DELETE TEST

This function allows cancelling an already programmed test. The display will show:
D e l e t e
t e s t
3 7 C
P T
P r e s s
T e s t
P R I N T
f o r
i s t
39

Enter a number to select the test you intend to cancel. If the position recalled is blank, the
device will be repeat the question.
The name of the test to be cancelled will be displayed: press Enter to proceed.
3.5.
UTILITIES
From the main menu, press (3) to carry out the following operations: 1: Photometer Calib
and 2: Settings
3.5.1. PHOTOMETER CALIB.
If you select this function you can check the Volt amplitude of the photometric signal of the
two reading channels. This function is used by the Technical Support staff.
3.5.2. SETTINGS
This function offers the following options:
Ask ID [y/N]
To request the ID number (8 characters) during text execution.
Auto Counter?
The program has been preset for printing the samples in

association with the serial number starting from 1.
You can vary this setting by pressing the serial number you
intend to start with.
Rec. Speed (2.5, 5, 10) :

cm/min
To select paper feed speed for the print of the reaction curve or
platelet aggregation plot.
.
To obtain a print of the calibration curve.
Calib. Curve
Print [Y/n]
Reaction curve
Print [y/N]
To obtain a print of the reaction curve. At the end of the print of

the curve, you have to press Print to obtain the results, even
though Autoprint is set.
Decimal temp [y/N]
To view degree centigrade tenths.
40
Ask ID [y/N]
To enter the date after turning the device on.
Enable host [y/N]
Enables transmission of results onto the serial port.
Baud rate
To set one of the 6 possible values for the serial port

transmission speed.
3.6.
AGGREGATION REC. (AGGREGATION RECORDING)

(RECORDING OF THE PLATELET AGGREGATION REACTION)
3.6.1. PRINCIPLE OF THE METHOD

The study of the platelet aggregation is based on a turbidimetric method that detects any
transmittance variations obtained in the platelet-rich plasma (PRP) after the addition of
aggregating substances (ADP, adrenalin, collagen, ristocetin, etc.). These substances
determine the formation of platelet aggregates with the consequent increase in transmittance
that can be monitored over time. The aggregometer records these variations continuously and
in this way printouts of the platelet aggregation curves can be obtained.
3.6.2. PREPARING THE SAMPLES

PRP (Platelet-rich plasma)
This is obtained by centrifuging the blood sample in 3.8% trisodic citrate (1 mL sol. Citrate + 9
mL blood) at 160 g for 15-20 minutes immediately after being collected. Transfer the plasma
with a plastic pipette into plastic test tubes and let the samples stand at room temperature.
PPP (Platelet-poor plasma )
This is obtained by centrifuging the same test tube of blood sample at 3000 g for 10 minutes.
The test must be carried out within 2-3 hours after the drawing, the PRP must be left at room
temperature. Five minutes are usually sufficient for the reading.
41
3.6.3. PREPARATION OF THE WORK SOLUTIONS

The preparation method of the work solutions is reported below for the most commonly used
aggregating substances in literature. The various reagents and buffer solutions necessary for
preparing the dilutions are available on the market.
ADP
Lyophilised solutions are available on the market for being reconstituted in order to obtain
ADP solutions with a concentration of 100M, that can be split into fractions to be stored at
-20C. In order to perform the test with the final concentrations of 1 and 2 M of ADP,
prepare two work solutions of 20 and 40 M (prospectuses A and B). The work solutions are
stable for two days at 2-8C.
(A) Preparation of the 20 and 40 M work solutions of ADP
200 L (ADP 100 M)
200 L (ADP 100 M)
+ 800 L (diluent solution)

0
ADP 20 M
ADP 40 M
(B) Performing of the test with final ADP concentrations of 1 and 2 M

15 L (ADP 20 M)
+ 0285 L PRP
ADP 1 M
15 L (ADP 40 M)
+ 0285 L PRP
ADP 2 M
Adrenalin
Lyophilised preparations are available on the market for reconstituting in order to obtain
adrenalin solutions with a concentration of 500M. This 500M solution may be stored for
several weeks at 4C. In order to carry out the aggregation reactions with concentrations of
10 M of adrenalin proceed with the preparation of a work solution of 200 M (prospectuses
C and D).
(C) Preparation of a 200 M work solution of adrenalin
200 L (Adrenalin 500 M)
Adrenalin 200 M
42
(D) Performing of the test with a final adrenalin concentration of 10 M
+ 0285 L PRP
15 L (Adrenalin 200 M)
Adrenalin 10 M
Collagen
This is available as a suspension to be stored at 4C. Carefully mix the suspension before
use. In order to perform the aggregation test with a final concentration of collagen equal to 5
g/mL it is recommended preparing a work solution with a concentration equal to 100 g/mL
and following the instructions indicated in prospectus E.
(E) Performing of the test with a final collagen concentration of 5 M
15 L (Collagen 100 g/mL)
+ 0285 L PRP
Collagen 5 g/mL
3.6.4. PERFORMING THE TEST

The instrument must be calibrated for each plasma sample analysed. The SEAC Clot 2S
aggregation foresees a calibration of 100 %, which corresponds to the transmittance of the
PPP, and 0%, which corresponds to the transmittance of the PRP, for each sample to be
analysed. It is possible to carry out the recording simultaneously on two channels.
In order to perform the platelet aggregation test select Utilities (3) from the main menu and
then Setting (2), and set the speed of the paper at 1 cm/min. in order to obtain a well
amplified plots.
In order to carry out the recording of the platelet aggregation plots on channels CH1 and CH2
proceed as follows:
1 :
T e s t
2 :
P r o g r a m m i
3 :
U t
4 :
A g g r e g a t
l i
e s e c u t
t i
i o n
n g
e s
i o n
r e c .
Select 4 from the main menu Aggregation rec.
Insert the metallic bars into the cuvettes.

43
A g g r e g a t
r e c
. 3 7 C
C H 1
R e a d
P P P
C H 2
R e a d
P P P
Insert the cuvettes containing 285 L of PPP of the sample to be analysed into the
reading cells 1 and 2, press reset 1 and reset 2 for the transmittance calibration of 100%.
A g g r e g a t
i o n
i o n
r e c
. 3 7 C
C H 1
R e a d
P R P
C H 2
R e a d
P R P
Insert the cuvettes containing 285 L of PRP of the sample to be analysed into the
reading cells 1 and 2, press reset 1 and reset 2 for the transmittance calibration of 0%.
A g g r e g a t
i o n
r e c
. 3 7 C
C H 1
R e a g e n t
C H 2
R e a g e n t
Remove the cuvettes from the reading compartment, add 15 L of the aggregation work
solution to the 285 L of PRP and shake delicately by hand. Re-introduce the cuvettes
into the reading cells 1 and 2.
Press reset 1 and reset 2 to start recording the plots of the reading channels 1 and 2.
Press stop at the end of the recording (approximately 5 minutes).
Press enter to set the instrument up for a new recording.
In the event of using one channel only, in order to use the other channel it will be necessary
to press enter at the end of the reading to return to the initial window.
44
3.6.5. INTERPRETING THE RESULTS

The platelet aggregation test has numerous variables so it will be necessary to carry out an
internal standardisation.
Depending on the type of aggregation substance used and the concentration at which the
reaction is carried out, the plots may be one of the four following types :
Monophase when there is only one platelet aggregation wave.
Biphase when, after an initial aggregation wave, there is an arrest in the transmittance
variation following a complete aggregation represented by a secondary wave.
Reversible when there is an initial increase in the transmittance followed by a gradual

return to the original values.
Irreversible when there is a progressive increase in the transmittance.
By analysing a platelet aggregation graph is it possible to gain information regarding both the
quantitative and qualitative nature indicated schematically as follows.
Information of a qualitative nature:
Shape change: this corresponds to a change in shape of the platelets which turn from
discoidal into spherical. This change, being connected to a reduction in the transmittance
percentage, is detected by the aggregometer and recorded as a brief plot under 0%.
Reversible primary wave: this indicates the occurrence of an aggregation due

exclusively to the action of an esogenous aggregating agent.
Secondary wave: this detects the releasing of the platelet granules. The two waves,
primary and secondary, can be visualised on the curve, however with high concentrations
of inductor or in hyper-aggregating states, they may fuse and form one single irreversible
monophase wave.
Information of a quantitative nature:
Latency time: this indicates the time necessary at the beginning of the aggregation after
the addition of the inductor and is important for studying the aggregation of collagen.
45
Slope: this indicates the percentage of platelets that aggregate within the time unit. It
therefore expresses the aggregation or disaggregation speed.
Aggregate Quota % or Q.A %: this is the highest level of transmittance reached by the
aggregation curve; it constitutes one of the key points in the aggregative response and
represents the maximum quota percentage of aggregated platelets.
3.6.6. AGGREGATION CURVES

The reaction of the platelet aggregation is shown schematically following a stimulus with ADP,
adrenalin and collagen, reagents amongst the most frequently used in literature, in relation to
their concentration.
1 M ADP
Normally reversible monophasic curve, at times biphasic with the presence of a second
curve due to the release of endogenous ADP (degranulation phase). In the event of a
second curve this will usually follow a hint of disaggregation, immediately concealed by
the aggregometric release response. In this case these two events, primary wave and
release (with the consequent secondary wave) in part take place simultaneously.
The aggregation speed is calculated from the tangent of the initial slope of the curve,
irrespective of whether mono or biphasic.
2 M ADP
Monophasic curve, irreversible.
Q.A. exceeding the one relating to ADP 1M.
The aggregation speed is calculated as in the case of the ADP 1M, that is, with the
tangent of the initial slope of the curve.
10 M Adrenalin
Biphasic curve with an initial low speed curve (expression of the affinity between
esogenous adrenalin and the receptor) immediately followed by the second curve relating
to the active response showing the higher speed. In therapies with aspirin or similar, and
due to the defect of the release phase of the granules, the second curve may be missing
altogether.
If the curve is biphasic, calculate the slope of the second curve which is usually higher
than the slope of the second curve.
46
5 g/mL Collagen
Monophasic curve preceded by the typical latency phase and simultaneously shape
change (increase in the transmittance).
The Q.A. and the aggregation speed are usually high seeing that this is an agent with a
high aggregating potential.
The Q.A. may appear to be reduced in patients who take aspirin.
Aggregated quota and type of curve in relation to the aggregating agent and its concentration.
The reference interval is carried out with the Clot 2S instrument.
Aggregating instrument
(final concentration in the PRP)
Aggregated quota
Type of curve
ADP 1M
17%-57%
Reversible
ADP 2 M
38%-100%
Irreversible
Adrenalin 10 g/mL
62%-100%
Biphasic
Collagen 5g/mL
62%-100%
Irreversible
47
Examples of aggregation curves:
A: ADP 1 M Reversible curve
B: Collagen 5 g/mL Irreversible curve

(1): Latency time
(2): Aggregation quota %
C: ADP 2 M - Irreversible curve
48
3.6.7. PRACTICAL ADVISE FOR ASSESSING THE AGGREGOMETRIC

PLOTS
In the global assessment of the platelet aggregation, always keep the following parameters in
mind, listed below in order of importance:
The shape of the curve; monophasic, biphasic, reversible or irreversible, characteristic of

each aggregating agent and its concentration.
The Q.A.% seeing that it is the objective expression of the aggregating potential.
The presence and duration of the latency phases (collagen).
Any absence of the first curve and the delay in the appearance of the second curve (rare
events).
The slope has minor diagnostic weight due to being influenced in part by the platelet
concentration of the PRP, which differs from one sample to the next.
3.7.
TEST
3.7.1. MANAGEMENT OF SAMPLES
Take venous blood samples with extreme care. The blood shall not be contaminated by
any foreign matter, such as small flaps of fabric, as they might alter coagulation time.
Blood dilution with anticoagulants must be strictly exact and constant for all samples.
Gently mix the blood with the anticoagulation agent in a silicone glass tube or a
waterproof plastics tube.
Separate the plasma from the particle fraction as soon as possible, in any case not later
than 30 minutes after you have taken the sample.
In order to prevent obtaining samples with different characteristics, plasma separation

must be done at the same centrifugal force for all samples (1800g 3000 rpm).
If the test is not carried out immediately, the plasma can be stored at +4C for a few
hours.
49
Use distilled and preferably sterile water.
3.7.2. TEST PROGRAMMING

Based on the operating procedures recommended for the use of SEAC reagents, minimum
parameters have been introduced for the use of methods for the determination of prothrombin
time, activated partial prothrombin time, fibrinogen and thrombin time.
Below is a table with an example of programming of the same methods where all the setting
parameters have been introduced to obtain results expressed in different measurement units.
Parameters
PT
APTT
Fibrinogen
TT
Test
Test name
PT
APTT
FIB
TT
Incubation time
Units
Sec, Ratio,
INR, Act%
Sec
mg/dL
Sec
Units to display
Sec
Sec
Sec
Sec
Nr. of standards
Insert Standards
STD1 :12.5
STD2 : 25
STD3 : 50
STD4 : 100
STD1 : 62,5
STD2 : 125
STD3 : 250
STD4 : 500
Repeat standards
Edit time for

standards
STDn. Time
No
No
Hight Limit
Press Enter
Do not insert
Press Enter
Do not insert
50
Low Limit
Press Enter
Do not insert
Press Enter
Do not insert
Scale
Log-Log
Log-Log
ISI
1.35
Autoprint
Yes
Yes
Yes
Yes
Save method
Yes
Yes
Yes
Yes
3.7.3. PROTHROMBIN TIME (PT)

Calibration
In order to calculate the results expressed in Act%, a calibration curve must be built. To
this purpose, a pool of human plasma can be used (100% activity) collected from
healthy volunteers who are not taking any drug, or lyophilized control plasma, which
must be dissolved in distilled water, whose value is provided by the manufacturer in a
specific leaflet supplied with the package.
Starting with the human plasma pool or control plasma, prepare scalar dilutions with
saline solution to obtain standards with the programmed prothrombin activity
percentages (100%, 50%, 25%, 12.5%).
Execute 2 determinations for each standard following the calibration procedure (par.
3.3.2) and the procedure determination described below.
Use STD4 standard as a reference plasma for the calculation of the Ratio and INR.
If you do not want to build a calibration curve, you can refer to the table that comes with
each of thromboplastin batch and introduce the seconds corresponding to the preset
concentrations, as described in paragraph 3.4.1.
You can obtain a print of the graph at the end of calibration.
51
Determinations
Perform the readings as described in paragraph 3.3.3.
Place the measurement cuvettes in the thermostat at least 10 minutes before

determination and then add a magnetic agitator to each cuvette.
Distribute 200 L of thromboplastin reagent in the measurement cuvettes provided with

a thermostat; press timer1 or timer2 and leave in incubation for the preset time (5 min.)
until you hear a beep.
To start the test, transfer the cuvette into the measurement cell by gently stirring it and
press reset1 or reset2, depending on the channel you are using. When 0.0 is shown in
the display, you can start to take the measurement.
Add 100 L of plasma. The timer will start counting the coagulation time and
automatically stop when the reaction has taken place.
Finally, you can obtain a print of results.
52
Note: We recommend that the measurements be taken in duplicate and that the
measurement of one control plasma be repeated for each working session.
3.7.4. ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)

Determinations

Distribute 100 L of plasma and 100 L of APTT reagent pre-heated at 37C into the
measurement cuvettes provided with a thermostat; press timer1 or timer2 and leave in
incubation for the preset time (3 min.) based on the method adopted until you hear a
beep.
To start the test, transfer the cuvette into the measurement cell and press reset1 or
reset2, depending on the channel you are using. When 0.0 is shown in the display,
you can start to take the measurement.
Add 100 L of calcium chloride (CaCl2 0.025 M) pre-heated at 37C in the thermostat.
The timer will start counting the reaction time and automatically stop when the reaction
has taken place.
53
3.7.5. FIBRINOGEN ASSAY

Calibration
In order for the fibrinogen (mg/dL) to be quantitatively determined, a calibration curve

must be built. To this purpose, you can use a pool of human plasmas at a known
fibrinogen concentration or a lyophilized control plasma that must be dissolved in
distilled water, whose value is provided by the manufacturer in a specific leaflet supplied
with the package.
Starting with the human plasma pool or control plasma, prepare scalar dilutions with the
imidazole solution provided with the kit at the programmed concentrations (500, 250,
125, 62.5 mg/dL).
Execute 2 determinations for each standard following the calibration procedure (par.
3.3.2) and the procedure determination described below.
If you do not want to build a calibration curve, you can refer to the table that comes with
each fibrinogen batch and introduce the seconds corresponding to the preset
concentrations, as described in paragraph 3.4.1.
You can obtain a print of the graph at the end of calibration.
Determinations

54
Distribute 200 L of the plasma being tested diluted according to the method described
into the measurement cuvettes provided with a thermostat; press timer1 or timer2 and
leave in incubation for the preset time (2 min.) based on the method adopted until you
hear a beep.
Add 100 L of fibrinogen reagent pre-heated at 37C: the timer will start to count the
reaction time and automatically stop when the reaction has taken place.
Note:
For fibrinogen concentrations lower than 100 mg/dL or greater than 500 mg/dL,
repeat the determination using different dilutions.
We recommend that the measurements be taken in duplicate and that the
3.7.6. THROMBIN TIME (TT)

Determinations

55
Distribute 200 L of the plasma being tested into the measurement cuvettes provided
with a thermostat; press timer1 or timer2 and leave in incubation for the time preset
based on the method adopted (2 min.) until you hear a beep.
Add 200 L of thrombin reagent. The timer will start counting the reaction time and
automatically stop when the reaction has taken place.
56
4.
MAINENANCE AND TYPES OF FAULTS
4.1.
MAINTENANCE
Scheduled servicing will help maintain the device in the best working conditions. We
recommend that the operations described below be regularly carried out:
4.1.1. EXTERNAL CLEANING OF THE INSTRUMENT
Clean the external surfaces of the instrument with a brush to remove the dust
Remove any dirt trace or other by using a slightly dampened cloth.
WARNING:
Do not clean the instrument with compressed air or solvents that may
damage the paint.
4.1.2. CLEANING OF THE READING CELL

Check for the presence of any foreign matters in the reading cells. If you find any, remove
them with nippers.
Do not clean the reading cells with liquids or cloths or paper, as they may release materials
that may obstruct the optic path.
57
4.1.3. PRINTER PAPER REPLACEMENT

Follow the steps listed below:
Open the panel of the paper compartment;
Introduce a paper roll in the paper guide of the printer;
Press Feed to cause the paper roll to slide.
58
Introduce the paper roll in the paper compartment.
Close the panel of the paper compartment.
Figure 4.1 - Print paper replacement
59
4.2.
TYPES OF FAULTS
Should any anomaly occur, the instrument will suspend the execution of any operation and
one of the messages listed in the table below is displayed. Press Enter to cancel the
message displayed and recover operation.
Test Execution Errors
Message
Cause
Remedy
Undefined Test
The test required has not been previously Programme the test.
programmed.
Curve Not
Defined
The calibration curve has not been Perform the calibration.

previously stored in the memory.
Non-Monotonic The calibration curve is not monotone Check that the standards have
(always increasing or always decreasing). been read in the correct order
Curve
and repeat calibration.
Photometric Errors
Message
Cause
Remedy
Low Light
There is too little light for the photometric Repeat the measurement.
reading or insufficient volume in tube
Call Technical Assistance.
Too Much Light There is too much light for the photometric Repeat the measurement.
reading.
The photometric reading is unstable
Repeat the measurement.
No Homogenize The photometric reading is unstable
Bad Signal
No Stop Signal
The Stop signal has not been detected.
Not valid
0% and 100% values are not correctly

related between them.
(error during platelet aggregation plot
calibration).
60
Hardware Errors
Message
RAM FAIL AT
$xxxx
Cause
Remedy
No message is shown in the display.
Check the fuse.

The self-test procedure has detected a Switch off and on again.

reading/writing error at the address $xxxx. Call Technical Assistance.
PROGRAM NOT The bootstrap procedure has

detected the stored programme.
FOUND
not
Switch off and on again.

PROGRAM
CORRUPTED
The bootstrap procedure has detected an Switch off and on again.

altered programme in the memory.
NVRAM
Amnesia
The flash memory is empty or no longer

contains the programmed methods. This
may occur when the memory has been
cancelled or replaced.
Programme the test
NVRAM Failure
It is impossible to write on the flash

memory.

NVRAM Data
Mangled
The data container in the flash memory Cancel the memory and
are illegible.
programme the tests.
Filesystem
mangled
It is impossible to write on the flash Cancel the memory

memory.
programme the tests.
Temp ADC Fail
The A/D converter is not working correctly. Switch off and on again.
Printer Trouble
The printer is not moving correctly.
and

61

Manual de Uso Clot2S

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USERS MANUAL

Software ver. 1.1

CLOT 2S Users manual

CLOT 2S Users manual

CLOT 2S Users manual

GENERAL DESCRIPTION ....................................................................................... 11

INSTALLATION AND PRELIMINARY OPERATIONS............................................. 24

CLOT 2S Users manual

3.4. Test programming.................................................................................................. 35

MAINENANCE AND TYPES OF FAULTS ............................................................... 57

CLOT 2S Users manual

Figure 1.1 - Main layout ................................................................................................... 15

CLOT 2S Users manual

WE VALUE YOUR OPINION

CLOT 2S COAGULOMETER Users Manual Code 53872211

CLOT 2S Users manual

Use the instrument only after reading this manual.

II. SAFETY PRECAUTIONS

CLOT 2S Users manual

Refer all repair operations to Technical Support staff.

III. TECHNICAL FEATURES AND CIRCUIT TRANSIENTS

1 phase, neutral and ground

115 / 230 VAC

CLOT 2S Users manual

Caution: risk of electric shock

Caution: see attached documentation

Caution: biological risk

CLOT 2S Users manual

The device CLOT 2S is a semi-automatic coagulometer designed to test coagulation

Results can be expressed in different measurement units.

Connection to a Host Computer through RS232.

The device can be set to record the platelet aggregation plot.

CLOT 2S Users manual

PT, APTT, TT, Fibrinogen, Coagulation Factors and clot

Final work volume

= 300 L (reagent + plasma)

C.V. calculated on a group of 8 readings of normal

Magnetic agitation, by means of a metal armature.

Dry heated block.

30, for sample incubation; 2, for reagent vials; 2, for

15 keys for programming and device control; 4 keys for

Alphanumeric liquid crystal display, with 4 20-character

Graphic printer with

CLOT 2S Users manual

115 / 230 VAC

15 32C (during operation)

< 2000 m (during operation)

Electromagnetic Compatibility EUROPEAN DIRECTIVE

EUROPEAN DIRECTIVE on Electromagnetic

CLOT 2S Users manual

The computer (8) processing all the data.

Device operation can be summarized as follows:

CLOT 2S Users manual

Figure 1.1 - Main layout

CLOT 2S Users manual

The figure below shows a front view of the device.

Figure 1.2 - Front view

CLOT 2S Users manual

Alphanumeric 80-character display (4 lines x 20 characters)

CLOT 2S Users manual

Figure 1.3 - Alphanumeric keyboard

If you press /Yes, you can obtain the types

CLOT 2S Users manual