SERVICE MANUAL

Coagulometer

Coag – Chrom 3003

(CC – 3003)

The unit meets all safety requirements of the international norm EN 61010+A2
„Safety requirements for electrical equipment for measurement, control and
laboratory use”. Designation of the technical parameters meets the
requirements of norm EN 61010+A2.
Contents

1. Application of the Coagulometer CC - 3003 ................................................. 3

2. Technical Parameters ................................................................................. 3
2.1. General characteristic of the unit ........................................................... 3
2.2. Technical Parameters ........................................................................... 4
2.3. Principle of unit’s work .......................................................................... 5
2.4. Distinguishing work conditions .............................................................. 6
3. Measuring programs ................................................................................... 6
4. Unit Service ................................................................................................ 7
4.1. Installation ............................................................................................ 7
4.2. Arrangement and application of operating elements .............................. 8
4.3. Registration of the name of laboratory ................................................. 10
5. Unit usage ................................................................................................ 11
5.1. Measurements .................................................................................... 11
5.2. Results ............................................................................................... 14
5.3. Programming ...................................................................................... 15
5.4. Calibration .......................................................................................... 16
5.5. Tests .................................................................................................. 21
5.6. Printing of the measure results and of the kinetics of the reaction course .. 23
5.7. Quality Control ................................................................................... 24
6. Unit Preservation ...................................................................................... 24
7. The Removal of the Irregularities ............................................................... 25
7.1. General remarks ................................................................................. 25
7.2. Irregularities and their removal ............................................................ 25
8. Error Messages ......................................................................................... 26
9. Results Transmission Unit-Computer ......................................................... 27

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1. Application of the Coagulometer CC - 3003

The Coagulometer CC – 3003 is a semiautomatic specialized unit that allows

quick, cheap and simple performing of the following coagulation tests:
 PT + fibrinogen
 APTT
 Fibrinogen (Clauss)
 TT
 Coagulation Factors II, V, VII + X
 Coagulation Factors VIII, IX, XII + XII
 AT
 Protein C
 D – Dimer
 other (using chosen universal program)

2. Technical Parameters
2.1. General characteristic of the unit:

 amount of the tested material or pattern – 50 l

 reagent’s amount – 50 l (100 l)
 result’s reading – automatically from the calibration curves or calculated in
relation to the pattern
 types of results: time, index PT, index QUICK, INR, RATIO, fibrinogen
concentration in g/l or mg / ml, % activity, g/l
 single or double measurement in the same material (substance)
 memory after disconnection from the supply network:
 date and time
 up to 15000 results
 60 calibration curves
 calibration values & norms for each program
 measurement time: 4-300 sec (depends on the type of measurement)
 automatic systems of turbidity compensation (possible measurement of

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 lipemic, hemolysed and hepatitis plasmas)
 self-acting compensation of the optical track’s and cuvette’s contamination.

2.2. Technical Parameters:

2.2.1. Dimensions: 45 cm x 33 cm x 12 cm
2.2.2. Weight: 5 kg
2.2.3. Type of electric isolation / insulation: basic insulation
2.2.4. Installation class (protective type): II
2.2.5. Degree of contamination: 2
2.2.6. Control systems of the technical state of the unit:
 Tests: elementary, of LCD display, of the keyboard, of the printer
 Automatic control of the measuring module
2.2.7. Memory after disconnection from the supply network
 date and time
 up to 15000 results
 60 calibration curves
 calibration values and norms for each program
2.2.8. Thermostat (warm – up time: 37 0 C  0,5 0C / 5÷15 min
2.2.9. Number of measuring channels: 3
2.2.10. Number of measuring paths: 3
2.2.11. Measurement range
 4-300 s for time measurement
 1-999% for % activity
 0,01-9 U/ml for international units
 0,01-9 g/l for balance units
 1-999 mg/dl for balance units
 1-9999 g/l for balance units
 20-300 s for incubation stop – watch

2.2.12. Distributiveness / Distribution

 0,1 s for time measurement
 1% for % activity

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  0,01 U/ml for international units
 0,01 g/l for balance units
 1 mg/dl for balance units
 1 g/l for balance units
 1s for incubation stop – watch
2.2.13. Precision / Exactitude
  0,1 s for time measurement
  1% for % activity
  0,01 U/ml for international units
  0,01 g/l for balance units
  1 mg/dl for balance units
  1 g/l for balance units
 1s for incubation stop – watch
2.2.14. Repetition / Recurrence: CV up to 2,5% (for time measurement)
2.2.15. Others:
 length of the light wave: 405 nm
 graphical LCD display
 built – in thermal printer 110 mm, printing of results, setting of programmes
and reaction course
 automatic numbering of patients
 possibility to connect the unit with the computer network through output joint
RS 232
 socket type PS 2 for bar code scanner – patient number (Imax 120 mA)

2.3. Principle of unit’s work:

For chronometrical notations (PT, APTT, TT, Fibrinogen, Coagulation Factors)

we use the method of measurement of time of the optical density’s change that
appears during the coagulation reaction along with the simultaneous analysis
of the kinetics of the described reaction. Program of the unit checks the course
of reaction from adding of the initial reagent up to the end of the course of
coagulation reaction.

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The basic result (time) is calculated in accordance with the unit user’s program.
Measurement time is limited up to 300 s.
For measurements with usage of chromogen substrata we used the
measurement of the calorimetric reaction’s kinetics with the limit of measuring
time.
After the qualification of the rapidity of sample material’s absorption changes
there follows its corresponding calculation in relation to the rapidity of pattern
material’s absorption changes and later – giving of the final result.

2.4. Distinguishing work conditions

 environment temperature +15 0 C  +32 0 C
 relative humidity 5  85%
 atmospherically pressure 73  106 kPa
 vibrations, water, salt,
sand and dust content in the air possible little
 unit position horizontally  5%
 power supply 230 / 50-60Hz / 100VA
 fuse 1A
 installation class (protective type) II

3. Measuring programs

The coagulometer CC-3003 has 11 measuring programs.

Each program is marked with the number 1-5 (upper right corner on the
display), altogether there may be max. 55 programs. That allows the user, for
example, memorisation of calibration values and measurement parameters for
the reagents of different firms, or modification of the same program from the
point of view of the type of obtained results and prints.

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 Table 1
Programs list:
N.P. Name of Program Type of Results
Time, index PT, index Quick,
1 (1-5) PT INR, Fibrinogen
2 (1-5) APTT Time, RATIO
3 (1-5) Fibrinogen g/l, mg/ml
4 (1-5) TT Time, RATIO
5 (1-5) Coagulation Factors (Group I) % activity
6 (1-5) Coagulation Factors (Group II) % activity
7 (1-5) AT % activity
8 (1-5) D-Dimer g/l, ng/ml
9 (1-5) Protein C % activity
10 (1-5) Universal I % activity
11 (1-5) Universal II U/ml

Universal / all – purpose programs make it possible to develop measuring

ability of the unit and application to various types of reagents.
 Universal Program I – reactions of chronometrically type, range of
measuring time up to 300 s, calibration curve in linear – linear co-ordinates
(time - % activity), results in % activity.
Anticipated usage: protein nomination by the coagulation method.
 Universal Program II – reactions of colorimetrical type, measurement of the
reaction’s kinetics, measuring time 30, 60 or 90s, calibration curve in linear
– linear co-ordinates (increases - % activity), results in % activity.
Anticipated usage: heparine and others nomination by the method of
chromogen substrata usage.

4. Unit Service

4.1. Installation

The coagulometer CC-3003 is assigned for work and usage in closed and
warmed-up spaces under following distinguishing conditions:
 environment temperature +15 0 C  +32 0 C

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 relative humidity 5  85%
 atmospherically pressure 73  106 kPa
 vibrations, water, salt,
sand and dust content in the air possible little
 unit position horizontally  5%
 power supply 230V / 50-60Hz / 100VA
 installation class (protective type) II
 contamination degree 2

4.1.1. Connecting to the supply network

 Put connector of the network cable into the socket – contact on the back –
wall of the unit (check whether it is put proper and up to the end).
 Joint the cable with power supply 230V
ATTENTION! According to the safety the unit can be connected only to the
socket – contact with protective bolt!
 Switch on the unit with circuit – breaker situated on the back – wall.

4.2. Arrangement and application of operating elements

In front of the unit there’s the measuring block, keyboard with the display and
printer. On the back – wall of the coagulometer there are: circuit – breaker,
socket – contact of the network cable, protective bolt and output joint RS232
and PS 2.

4.2.1. Measuring block

The measuring block with thermostat serves for reagents incubation, test-tubes
incubation and for measure making.
Two left-side measuring holes suit for the chronometrical notations
(measurements) (PT, APTT, TT, Fibrinogen, Coagulation Factors). The right -
side hole suits for the chromogene measurements AT, Protein C and
D-Dimer.
Over the measuring holes there are moving conductors with the holes for the
pipette’s end. That allows precise and repeated adding of the initial reagent.

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4.2.2. The keyboard with the Display

Application of the keyboard :

MAIN MENU – choice of the type of unit work, return to the beginning

ADDITIONAL MENU – quick, current change of the setting

parameters of the unit without switching-on “Programming” option:
change of the parameters of the program used ad the
moment (number of measuring channels, Fibrinogen conditional in
PT program, Multiplier for fibrinogen), printing of the course of
reaction kinetics – see 5.6.3.)

Stop – watches of the incubation time

Printing of the measure results; moving forward (out) the paper

Acceptance of results, positive answer at unit question

Lack of acceptance; negative answer at unit question; removal of the

numeral
Additional button – manual start of the measurement; stoppage of the
measurement

Additional button – manual start of the measurement; stoppage of the

measurement

4.2.3. The Display

Applied graphical – text display assures comfortable and easy usage of the
unit. The program of the unit delivers on the display the whole information
about the present state of coagulometer’s work and about the possibility of its
change. In the lower part of the display one can find information about which
buttons are to be used in order to move forward to the next stage of the unit
work. On the left side, parallel to the buttons of the start of incubation time
there are two independent stopwatches measuring the time of incubation.

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4.3. Registration of the name of laboratory

By usage of the buttons with numerals one may enter the name and other data
of the laboratory on the results’ list. Table 2 demonstrates symbols
corresponding to the buttons with numerals.

TABLE 2
Symbols corresponding to the buttons with numerals

Button Corresponding Symbols / Signs

1 < > “
2 A B C
3 D E F
4 G H I
5 J K L
6 M N O
7 P Q R S
8 T U V
9 W X Y Z
0 - / space
, . , ‘ *
comma dot / full stop coma apostrophe star

In order to write down the corresponding text it is necessary:

 push the buttons

 with the button find the inscription “LABORATORY” and accept

 in place of the flashing cursor write down the corresponding sign

 Right side moving of the cursor – button

 Left side moving of the cursor – button

 Signs removal – button
Errors correcting – put the cursor on the wrong sign, remove the sign with
button and write down a new one.

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5. Unit usage

The choice of the kind of unit work is performed by pushing “MENU” button.
Particular kinds of work select service activities of the unit:

“MEASUREMENT”  execution of the tested or control material measures

“RESULTS”  review, printing or sending to the computer network of
the results of patents and quality controls filed in the
memory of the unit
“PROGRAMMING”  adaptation of the measuring parameters to various
reagent applications; choice of number of the active
measuring channels; choice of the type of results,
registration of the dimension of factor CV, registration
of the dimension of norms
“CALIBRATION”  insertion of reference (calibration) values
insertion of calibration curves
insertion of factor (coefficient) ISI for PT
“CONTROL”  measurements of the quality control
“TESTS”  execution of technical control of the unit

5.1. Measurements

“Measurement” option serves for the execution of tested or control material

measures.
Attention!
The main condition of getting proper measure results is to follow the required
instructions of the execution of measurements and calibrations. It is required to
use the same methodics, reagents of the same series and prepared
correspondingly, the same pipettes and the same kind of work as during th e
calibration of the unit.

5.1.1. Measurements Performing

Preparatory work:
 Prepare the reagents following producer’s instructions
 Check whether the series or type of the reagents was not changed (if this
took place – perform the calibration of the unit – see item 5.4.)

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 Collect blood with sodium citrate 3,2% in the proportion 1:10 (i.e. 1 volume
of anticoagulant + 9 volumes of blood) and mix the sample slowly and
gently in order to avoid hemolysis. Check that the sample is free from clots
and centrifuge it at 2000 rpm speed. The sample should be centrifuged
within 30 minutes after collection and can be stored in the refrigerator (no
longer than 3 hours)
 Check whether measuring holes are free from test-tubes

 With button find “MEASUREMENTS” option and accept

Example of the execution of measurements for PT (the unit is calibrated
and programmed in accordance with the example from item 5.4.1.1.a):

 With button find program “PT”

The program of the unit offers the lately used program, e.g., “1PT”. This
number can be accepted or changed with the help of numerals keyboard (from
1 to 5).
After the acceptation of the higher mentioned number, the program of the unit
suggests patient’s number, No = 1.
It is possible to accept this number or enter personal another one (up to
11 numbers) by keyboard or bar code scanner.
 Fill the test-tubes with patient plasma and reagents following the methodics

 With button set going the incubation stop watch

At the end of incubation time there comes sound signal (stop-watch continues
time measure).
 Transfer the test-tubes into the measuring holes
 When the starting mark. “Add reagent” appears pipette vigorously the last
(starting) reagent
 Automatic start of the measurement begins
 After measurement is fulfilled there appear the results and the variation
between the channels signified Cv ... %
Before the acceptation of the results it is possible to print the course of the
coagulation reaction in graphical form using “Accessory / Additional Menu” .

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If the result of fibrinogen measurement is not required:
 Choose from “Additional Menu” the position “Referential / Circumstantial
Fibrinogen” and accept the conditionality of the result with fibrinogen.
 Since that after each acceptation of the measure result the unit will put an
additional question “Result with Fibrinogen ?”.
 if we press the key “YES” the final result of the patient will contain
fibrinogen measure with PT and will be stored in the unit memory
 if we press the key “NO” the result of fibrinogen measure will be rem oved
from the final result of the patient and in this way will be stored in the unit
memory.
Notes:
1. The following messages may appear:

Please wait temp < 37 0C

Incubation block is heating this message can be neglected with pushing / the
button with comma.

Please wait light measure

Unit program checks the optical track (this can be neglected, see higher ).

Take out the test tube

Before the next measurement the unit checks the optical track, in case the light
level is too low there appears the higher given message, in order to start the
measurements it’s required to take out the test-tubes or press correspondently
buttons A or B.

Wrong Test – Tube

The test-tube is dirty, mat or scratched, or filled with the plasma that is too
thick optically: Error removal: press button A or B.

Thick Plasma
After the beginning of measurement automatic turbidity compensation is
impossible - scratched test-tube, too thick plasma or improper reagent error
removal: press the button A or B.

2. If the unit is programmed for the double performing of the measurement in

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 the same plasma (e.g. when one of the channels is switched off, or in case
of the double measurements in the same hole of the chromogen path, the
results appear in their turn after stoppage of the first and the secon d
measurements.
The final result is given as average from both results. Besides the unit gives
the variation Cv in % that allows to estimate the recurrence of the
measurements.

5.2. Results

“RESULTS” option serves for:

 review
 printing
 sending to the computer network patients’ results and Quality Control stored
in the memory of the unit
 clearing of the results and Quality Control stored in the memory of the unit
Review, Printing, Sending or Clearing of the Results

 With the button find the option “RESULTS” and accept

 Choose type of the activity:
 Review and printing of the results – “Patients” or “Quality Control”
 Sending of the results to the computer network – “Transmission”
 Insert date of the measurements (DD-day, MM-month), the program
suggests the current / actual / date along with the number of patients,
whose results are to be shown (from “to”) For the only patient e.g. No 3 give
only number from 3. If no number is given the unit searches automatically
for all numbers from 1 to 999.
For Quality Control only the date of the measure execution is given.
After the acceptation the unit performs chosen activity.
For the review of every next results on the display use the button ,
and for the printing of the result use the button “Printer”.

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5.3. Programming

“PROGRAMMING” option serves for the adapting of the measuring parameters

to various reagent applications.
Performing of the programming:

 With button find the option “PROGRAMMING” and accept

 Find the program e.g. PT and accept.
On the display of the unit appear questions dealing with measure parameters
and types of the results. The choice of the type of results (e.g. for PT they are:
Time, index PT, INR, Quick, Fibrinogen) is performed with the button by
changing (-) sign to (+) sign and accepting. Signs (-) or (+) appear on the
display next to the proposed type of the result. Using the methodics (or
reagents’ leaflets) insert corresponding data into the memory store of the unit.
The program is kept in the unit memory after the disconnection from the supply network.
Table 3
Programming of the Coagulometer CC-3003

Questions Possible Answers

Time, RATIO, index PT, INR, index QUICK,
Select analysis type
Fibrinogen – if given type of result is accepted
(type of the result for coaqulology
nearby appears sign (+), if no sign (-) (Choose)
only)
with the button “NO”, accept with button “YES”
Give incubation
from 20 to 300 sec – write with the keyboard
time
Give measurement duration
30 or 60 or 90 sec – choose with button “NO”
(only for substrates)
Single measure? Single or double – choose with button “NO”
Select reagent first – kit “IL Test D-Dimer”
(for D-Dimer only) second – kit Dade Behring “D-Dimer PLUS”
Give Cvmax % * ............ % - write with the keyboard
(for double measurements only) (it is possible to neglect – accept spare place)
Give norm from ... to ... – write with the keyboard
(necessary for print-list only) (possible not to give – accept spare place)

* Cvmax % defines / qualifies measures repetition for double measure in the same calibration
plasma. If Cvmax is exceeded there appears warning sound signal. Measure should be
repeated.

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 Table 4
Types of Results for Chronometrical Measures

Result Dimension Application Quotient

Time (sec) Thrombin Time
Index PT Prothrombin Time PT time calibration plasma
X 100%
(inadvisable now) time patient plasma
RATIO Prothrombin Time PT
(inadvisable now) time patient plasma
Time APTT time calibration plasma
Thrombin Time TT

INR Prothrombin Time PT (RATIO) ISI

ISI – sensivity coefficient of thromboplastin

5.4. Calibration

“CALIBRATION” option makes it possible to insert into the program of the unit
referential (calibration) values got from the calibration plasma measures.
Calibration is always performed after change of the reagent series or if control
measures are not (proper) correct.
Referential values serve for the execution of the required calculations and
obtaining of the final result.
Attention! Referential values read from the reagent leaflets of different
types of coagulometers can’t be applied for the unit CC-3003!

5.4.1. Calibration performance – Examples

5.4.1.1. Calibration PT
Example for reagents <Bio-Ksel>

Cat. No Description Reagent

843 521 main reagent Bio-Ksel System PT (ISI 0,98 – 1,1)

843 001 calibration plasma Bio-Ksel System Kalibrator

543 002 control plasma Bio-Ksel Eko Normal

843 742 diluent Bio-Ksel System Rozcienczalnik

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a) Programme the unit for PT measurement according to item 5.3.
Assume that the following types of results for PT were programmed and
selected:
 “index PT”
 “INR”
 “Fibrinogen”
During the calibration the unit program will measure referential time for
calibration plasma (for measuring of index PT and INR) as well as executed
calibration curve (for measuring of fibrinogen from PT). If “Fibrinogen” as one
of the types of results won’t be selected and programmed beforehand (item
5.3) unit program won’t perform the calibration curve.
b) With The special diluent Fibrinogen Diluent fulfil series 3 or 4 succeeding
dilutions of the Calibration plasma.

where: C1 – concentration of fibrinogen read from the leaflet of calibration

plasma for the reagent PT.

c) With button select option “CALIBRATION” and accept

With button select program PT and accept.

“REAGENT LOT: ………”

- write with the keyboard ( see also 4.3.)

“CALIBRATOR LOT: ……..”

- write with the keyboard ( see also 4.3.)

“DO CALIBRATION MEASUREMENT ?”

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“MEASURE NUMBER AT POINT [2-8] = .......... ? “

- recommend write “2“

If we execute beforehand planned 2 calibration measurements for calibration

time they will be marked as:
Tp(1) – for the first measuring calibration time (for example Tp(1) = 11.3 s)
Tp(2) – for the second measuring calibration time (for example Tp(2) = 11.1 s)
Average measuring calibration time:
Tpavg = (Tp(1) + Tp(2)) : 2 (for example Tpavg = 11,2 s)
“ENTER CORRECTION  =........” (for example  = 1.13)
 - correction index (with the Calibration Plasma leaflet, or  = 1)

“CALIBRATION TIME Tk = 12,7 s” (example) Tk = Tpavg x 

“ENTER INDEX ISI = ........”

- write with the leaflet of the reagent PT

 after ending of the operation:

 calibration curve measures for fibrinogen from PT
“Number of curve points [2-5] = ..........? ”
- give 3 or 4 points depending on the number of the fulfilled dilutions of the
calibration plasma
“MEASURE NUMBER AT POINT [2-8] = .......... ? “

- recommend write “2“

“ENTER C1 = .............. g/l ? “

- where: C1 – fibrinogen concentration is taken from the leaflet of calibration
plasma for the “Fibrinogen with PT”.
- execute calibration measures
- answer the next questions set by the program of the unit and execute
calibration measures.
Remarks:
 calibration measures can be executed or calibration values (registrated)
can be send to the unit memory with the help of the keyboard
 if we execute 2 planned beforehand calibration measures for each point of
the calibration curve, they are defined as:

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 D1 = (D1(1) + D1(2)) :2 for the first point of the calibration curve
D2 = (D2(1) + D2(2)) :2 for the second point of the calibration curve
D3 = (D3(1) + D3(2)) :2 for the third point of the calibration curve etc.
Out of the performed measures the program of the unit calcul ates the average
value and the coefficient correlation (the variation) Cv %.
In case of performing of more measures for one of the calibration curve (e.g. 4)
the program of the unit rejects 2 extreme values.
 note inserted values and archieved measure results. In case of error or
calibration repetition it is possible to insert earlier achieved results into the
unit program with the help of the keyboard.
d) When the coagulometer has measured the last point of the calibration
curve, it indicates the coefficient correlation “r”. If the “r” > 0,95 the
calibration is OK. If the “r” < 0,95 then calibration has to be repeated.
Warning !
If calibration values (registrated) can be send to the unit memory with the help
of the keyboard, the PROGRAM PARAMETERS RAPORT and RESULTS
RAPORT will be include the following signs: “LOT: #######” .

5.4.1.1. Calibration – Fibrinogen (by the Clauss method)

Example for the reagents

Cat. No Description Reagent

543 741 main reagent Bio-Ksel Eko Fibrynogen

843 001 calibration plasma Bio-Ksel System Kalibrator

543 002 control plasma Bio-Ksel Eko Normal

843 742 diluent Bio-Ksel System Rozcienczalnik

a) Programme the unit for Fibrinogen measure according to item 5.3

b) With the special diluent Fibrinogen Diluent fulfil series 3 or 4 dilution s of
calibration plasma

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 Fibrinogen
Dilution Concentration Calibration Plasma Diluent
(for example)

C1 1:10 3,6 g/l 50 l 450 l

C2 1:15 2,4 g/l 50 l 700 l
C3 1:20 1,8 g/l 50 l 950 l
C4 1:30 1,2 g/l 50 l 1450 l

where: C1 – fibrinogen concentration is taken from the leaflet of calibration

plasma for the reagent Fibrinogen.

c) With button select option “CALIBRATION” and accept

With button select program – “FIBRINOGEN” and accept

d) answer the questions set by the program and execute calibration measures
Remarks:
 calibration measures can be executed or calibration values (noted /
registrated beforehand), can be send to the unit memory with the help of the
keyboard
 if we execute two earlier planned calibration measures for each point of the
calibration curve, they are defined as:
T1 = (T1(1) + T1(2)) :2 for the first point of the calibration curve
T2 = (T2(1) + T2(2)) :2 for the second point of the calibration curve
T3 = (T3(1) + T3(2)) :2 for the third point of the calibration curve etc.
Out of the performed measures the program of the unit calculates the average
value and the coefficient correlation (the variation) Cv %.
In case of performing of more measures for one point of the calibration curve
(e.g. 4) the program of the unit rejects 2 extreme values;
 note inserted values and achieved measure results. In case of error or
calibration’s repetition it is possible to insert earlier achieved results into the
unit program with the help of the keyboard.
When the coagulometer has measured the last point of the calibration curve, it
indicates the coefficient correlation “r”. If the “r” > 0,95 the calibration is OK. If

20
the “r” < 0,95 then calibration has to be repeated.
Warning !
If calibration values (registrated) can be send to the unit memory with the help
of the keyboard, the PROGRAM PARAMETERS RAPORT and RESULTS
RAPORT will be include the following signs: “LOT: #######” .

5.5. Tests

“TEST” option serves for the inspection of the technical state of t he unit.

 With button select option “TESTS” and accept.

 With button select type of the test and accept with button “YES”.
a) “DISPLAY TEST” – program performs self-acting display test presenting
successively all signs; ending with any button
b) “KEYBOARD TEST” – check if all keys work correct by pressing
successively all the keys. Ending: press twice button
c) “LIGHTS TEST” – During the process of measurement the unit on the
display appears message “LIGHTS CONTROL”, the unit gives / prese nts
values for light level for channels A and B, as well as for channel C – after
pressing the button
Reading is performed after the disappearance of the message “Test” should be
executed for empty measuring holes!
Displayed light level informs about state of the optical track (light intensity).
The proper value should go into the section from 3050 to 4050. If light level is
lower than 3050 it is necessary:
- to clear out the optical track
- to execute the automatic adjustment of the light pushing the key “YES”
(entry code “220565).
The Program sets the light intensities automatically for channel A and B.
Perform the same for channel C.
If the light values are still bellow 3000 it is required to call for a service.

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 During the execution of the measurements the announcement “Take out the
test-tube” may appear inspire of the blank measurement socket (without
test-tube). If testifies the dirty measurement socket or too weak light. The
further work of the unit is possible in case of pushing the appropriate key
“A”, “B” or “C”, but be ready that the parameters of the unit will become
worse.
Ending: press button “NO”.
d) “PRINTER TEST” – is to be executed in case of any wrong activity of the
printer, button “YES” – execution of the test; button “NO” – ending
e) “MEASURING MODULE TEST” – this test is destined for the service; it
displays the following parameters (example values for one channel)
Temp. A: 4095 LED*
TROK D: 0001 DOK
 Value after A letter: light intensity by LED* light
 Value after D letter: instability of light
If drift is < 0010 index DOK (drift OK.) is set, if not – index DERR (drift ERR)
 TROK (thermoregulator OK.) – information that the unit has reached 37 0 C
by warming up if not 4 dashes appear.
 LED* instead of “*” sign it is possible to set from the keyboard values from 0
to 4 which correspond to the level of light intensity of measure diode LED.
The diode is switched off after pressing of the button “0” (A: 0000  0005). It
is also possible to observe the change of the light intensity (after “ A” letter)
with the help of putting in and taking out of the measuring holes some test -
tubes.
Ending – press button “NO”.
f) “TRANSMISSION TEST” – execution of the test accept with button “YES”,
the unit automatically sends test signs to the computer network.
To break the test – press button “YES” one more time.

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5.6. Printing of the measure results and of the kinetics of the
reaction course

5.6.1. Setting the type of printer operation

The type of printer operation is totally set for all types of

measures:

 press in order buttons

 with button select “PRINTER” and accept

 choose one of the three types of printer operation:
a) “bath” – summary print-list of all the results for the given patient
b) “auto” – self-acting printing of the results after ending and
acceptation of each measure
c) “off” – printer is off

5.6.2. Printing of the measure results – 3 ways / possibilities:

a) If printer is set in the type of printer operation “Automatic printing” (see item
5.6.1.) the print read out follows self-acting after ending of every measure
and after results acceptance with button “YES”. Printed out is current /
present accepted measure only (the other measures performed for the given
patient aren’t printed out). Despite of this the summary print read-out for the
given patient can be obtained in “Results” option.
b) If printer is set in the type of printer operation “Summary printing” the unit
doesn’t prints the results after ending of a single measure. The print read -
out can be obtained at the end of series of measures in “Results” option.
c) Print read-out can also be obtained (no matter which type of printer
operation “Summary” or “Auto” is set ) just after the ending of the measure
before result acceptance:
 wait for ending of the measure and appearing of the result on the display screen
 press button “Printer”
Note! Attention! The above mentioned possibility is inaccessible if the type of
printer operation is set on “Disconnected Printer”.

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5.6.3. Printing of the course of reaction kinetics

Print read-out of the reaction kinetics in graphical form:

 wait for the ending of the measure and appearing of results on the display
 press button “Additional Menu” and select “Reaction PRINTING”

5.6.4. Printing of the Program Parameters

- press button “Main Menu”,
- select MEASURES or PROGRAMMING or CALIBRATION
- select program, e.g. “1 PT”, press button “Printer”

5.7. Quality Control

Measures of Quality (Inspection) are performed in the following way:

 from “MAIN MENU” select option “Quality Control”
 select type of unit program (e.g. PT)
 enter in order the expected range of values (from ... to ...) from the leaflets
of control plasmas
 using control plasma perform the test
 after stoppage of the counters check whether results correspond to the
value range of control plasmas (it is possible to print the result of Quality
Inspection with button “PRINTER”)
If results are not correct perform the calibration of the unit. Remember that this
analytic activity was the same for the calibration, measures and Quality Insp.

6. Unit Preservation

The unit needs no special preservation’s actions and periodic inspections

fulfilled by Producer’s service.
Preservation of the unit:
 daily: after the fulfilment of the operations insert empty test-tubes into the
measuring cavities in order to protect them from the dust. Put cover on the unit.
 periodic: once in 14 days clear the measuring cavities from the dust by
blowing them through with the rubber pear
 in care the cavities are flood with same liquid clean and dry them with the

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 gauze on the pincette. After the cavities get dry check the state of optical
track (as in item 5.5.c) – light control.

7. The Removal of the Irregularities

7.1. General remarks:

For proper work of the unit usage of new test-tubes only is strictly required.
Usage of washed – up test-tubes is forbidden!
Use clean and dry test-tubes only.

7.2. Irregularities and their removal

 The automatic start does not engage:

 reagent added too slowly – add vigorously or at the moment of addition
press button “A” or “B” After inserting of the test-tube into the measuring
cavity there appears a message: “Wrong test-tube”
 test-tube is dirty, scratched or filled with too dark plasma
 exchange the test tube
 The counter starts too early before the reagent is added:
 automatic start is engaged as a consequence of the test-tube moving or
of unit shock. Stop measure by pressing button “A” or “B”, take test -tube
out of the measuring cavity and press one more time button “A” or “B” to
find the message “Insert Test-Tube”:
 the test-tube was put into the measuring cavity while there was message
“Add REAGENT” on the display. Read messages on the display
attentively! Act as higher mentioned
 Big / Great divergence of measure results for the same plasma:
 not precise dosage – change pipette or endings, check whether reagent
or patient plasma leave no traces on the walls of the test-tube
 improper reagents – change the series
 distillation water used for dissolution is of bad quality. Don’t use water
from distillers and redistillers. Use water assigned for injections from
protection packages.

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 Control result in particular days doesn’t repeat:
 the reason for this may be improper preservation of the reagents –
mainly of the thrombin (change of the activity). Follow the instructions of
preservation given in the methodics. Store thrombin frozen in the test-
tubes with rubber seal
 careless dosage – change the pipette, change single endings, care that
there were no drops of patients plasma and reagents on the walls of test -
tube.

8. Error Messages

“Absence of communication with measuring block”

Interruption or break in communication between measuring module and
calculating module.
Reaction: press any button and repeat the function during which there
appeared an error or switch off and in some seconds switch on the unit, check
that measuring socket is free from test-tube which is to be taken out. If nothing
mentioned above helps call for the service.
“Low Battery”
Tension of the inner accumulator is lower than possible 2,5V.
Reaction: press any button to continue the unit program. Service intervention
is obligatory to replace the accumulator
“Attention: Lights instable”
The coagulation time during light drift measure has exceeded 2 minutes.
Reaction: press any button to continue the unit program. Service intervention is
obligatory to find the reason for light instability.
“Printer Error”
The printer isn’t ready for printing operation longer than 30 sec.
Reaction: press any button to continue the unit program. Select “TESTS” and
perform PRINTER TEST. If the message appears again call for the service.
“Transmission Error”
During sending of the results to the computer network transmission was
interrupted for more than 5 sec.

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When the unit works normally such message doesn’t appear.
“Take out the test-tube”
Putting aside empty measuring cavity (without test-tube). That testifies to dirty
measuring cavity or too faint light. Further work is possible on pressing button
“A” or “B”, remember about the worse state of the unit parameters. Service
intervention is obligatory.

9. Results Transmission Unit-Computer

The output joint type RS232 is used to transfer the measuring results
accomplished by the coagulometer CC-3003 to the central computer. Its
physical parameters are:
 transmit: asynchronous, arranged in rows
 transmit speed: 9600 Bd
 word length: 8 bits
 stop bits: 1
 evenness control: without control

Two transmission lines TxD and RxD as well as signal mass are used for
transmission. These signals are utilised in a manly connection type DB9 which
is situated on the back-wall of the unit, according to numbers of joint:
3 – TxD
2 – RxD
5 – GND
The rest joints aren’t used.
The structure of data sending to the computer is always the same and can
consist of max 58 bits during one transmission. Every transmission block
begins with the heading “CC-3003” – presenting the name of the coagulometer
and each block is ended sign of the line end CR with code $OD and LF with
code $OA. The unit transmits only signs ASCII which form one text record.
Appearance of a sign beyond this range is considered to be transmission error.
Records are divided into 3 types:
 the one initiating transmit block
 the one containing measure results
 the one ending transmit block

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Below there’s a demonstrative print read-out of text record containing results
for patient No 1 (without signs CR & LF).
CC-3003 BEGIN 27-02-2002
CC-3003 00000000001 PT CZAS 29.9 s 12.6 15.612:09
CC-3003 00000000001 PT WSK. 45 % 85 105 12:09
CC-3003 00000000001 PT INR 2.23 0.95 1.0212:09
CC-3003 00000000001 PT FIBR. 582 mg/dl 270 360 12:09
CC-3003 00000000001 APTT CZAS 23.2 s 35 45 12:38
CC-3003 00000000001 APTT RATIO 1.68 0.95 1.0312:38
CC-3003 00000000001 FIBRYNOGEN 6.01 g/l 2.7 3.5 12:58
CC-3003 00000000001 TT CZAS 67.8 s 13:12
CC-3003 00000000001 TT RATIO 4.84 13:12
CC-3003 00000000001 CZ. VII+X 407 % 75 110 13:26
CC-3003 00000000001 D-DIMERY 0 ug/l 45 147 13:45
CC-3003 00000000001 CZ. XI+XII 109 % 85 105 13:47
CC-3003 00000000001 ATIII 24 % 83 106 13:59
CC-3003 00000000001 UNI-I 51 % 50 120 14:03
CC-3003 00000000001 UNI-II 43 % 78 113 14:04
CC-3003 00000000001 UNI-III 0.39 U/ml 0.56 2.56 14:05
CC-3003 END 27-02-2002

Number of fields depends on the type of record: the ones initiating and ending
transmit block consist of 2 fields only, result block has 8 fields.
Record beginning the transmit block has Identificator “CC-3003”, key / entry
word “BEGIN” and the date of the execution of results transmission “27-02-
2002”. Record ending the transmit block has identificator “CC-3003”, key / entry
word “END” and repeated date of the results execution “27-02-2002”.
Results record contains Identificator “CC-3003”, patient's number (11 numerals),
name of the program, type of measure, result of measure, unit, norm from,
norm to and incubation time.
Individual fields of the record are divide with spaces (with code $20). All
numerical values are transmit without insignificant zero – substituted with
spaces.
After record transmit computer must confirm the correctness of transmission by
sending back Xon / Xoff. Sending Xoff sign with code $13 computer suspends
transmission of data. Transmission continues after sending Con sign with code
$11. In case of absence of confirmation Xon or Xoff during 5 seconds
transmission is interrupted, on the display appears inscription
“Transmission Error!”.
In order to perform the transmission of the measure results select “Results”
option, then select “Transmission” option. Now give date of measure execution
and patient number, whose results are to be transmitted. After insertion of the
patient’s number the unit starts transmission. On the display appears message
“Please” wait TRANSMISSION LASTS”. After transmission is finished the unit
automatically comes back to “Results”.

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