C2000-2 SEMI-AUTO

COAGULATION ANALYZER

OPERATOR’S MANUAL
 CONTENTS

1 About This Manual ................................................................................................... 1

1.1 Introduction ................................................................................................... 1

1.2 Who Should Read This Manual .................................................................... 1
1.3 Warning Symbols .......................................................................................... 1
1.4 Safe Symbols ................................................................................................ 2
2 Understanding Your Analyzer ................................................................................... 3

2.1 Introduction ................................................................................................... 3

2.2 Principle of the measurement ....................................................................... 3
2.3 Test Items ...................................................................................................... 3
2.4 Features ......................................................................................................... 4
2.5 Main Technical Parameters ........................................................................... 4
2.5.1 Normal Working Condition .................................................................. 4
2.5.2 Temperature .......................................................................................... 4
2.5.3 Specification ......................................................................................... 4
2.5.4 Contraindications .................................................................................. 4
3 Installing Your Analyzer ........................................................................................... 5

3.1 Introduction ................................................................................................... 5

3.2 Installation procedure ................................................................................... 5
4 Operation .................................................................................................................. 6

4.1
Introduction ................................................................................................... 6
4.2
Operation ...................................................................................................... 7
4.2.1 Start menu ............................................................................................. 7
4.2.2 Setup ..................................................................................................... 7
4.2.3 Refs ....................................................................................................... 8
4.2.4 Cali ........................................................................................................ 9
4.2.5 Test ...................................................................................................... 11
4.3 Operation of software ................................................................................. 12
5 The Expressions of Laboratory Results .................................................................. 13

5.1 The definition of units .................................................................................... 13

5.2 The expression mode of the selectable laboratory results ............................. 13
6 Maintenance and Cautions ...................................................................................... 14

6.1 Maintenance ................................................................................................... 14

6.2 Cautions ......................................................................................................... 14
7 Storage and Transport ............................................................................................. 15

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 7.1 Storage ........................................................................................................... 15
7.2 Transport ........................................................................................................ 15
8 Disposal of Castoff ................................................................................................. 16

Appendix1 Precil Test Cup and Steel Ball................................................................. 17

1 Configuration and Capability............................................................................ 17

2 Use .................................................................................................................... 17
3 Cautions ............................................................................................................ 17
4 Storage .............................................................................................................. 17

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 1 About This Manual

1.1 Introduction
This chapter explains how to use your C2000-2 operator's manual. This chapter
explains how to use your operator’s manual, which is shipped with your SEMI-AUTO
coagulation analyzer and contains reference information about the C2000-2 and
procedures for operating, troubleshooting and maintaining the analyzer. Read this
manual carefully before operating your C2000-2 analyzer and operate your C2000-2
SEMI-AUTO coagulation analyzer strictly as instructed in this manual.

1.2 Who Should Read This Manual

This manual contains information written for clinical laboratory professionals to:
� Learn about the C2000-2.
� Customize system settings.
� Perform daily operating tasks.
� Perform instrument maintenance and troubleshooting.

1.3 Warning Symbols

The following symbols are used to indicate danger and alert information on the
instrument.
Symbols Meaning
Inside of Please notice the PCB, do not touch and measure it when
instrument electrified.
There is blood in the test cup, please wear medical gloves. Used
cup should be disposed as medical waste appropriately for the sake
of avoiding potentially biohazardous condition.
External of
instrument Caution, the running instrument has hot surface!

Do not put steel ball in the stir hole!

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1.4 Safe Symbols
The following symbols are sticked in or on the instrument; user should comprehend
the meaning.
Symbols Meaning
Caution, consult accompanying documents. Note: suggesting the
users consult to accompanying documents to get important
safety information.
On (power: connection to the mains)
Off (power: disconnection to the mains)

Protective earth (ground)

For in vitro diagnostic use

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 2 Understanding Your Analyzer

2.1 Introduction
Model C2000-2 has 2 test areas and 6 preheat slots. The instrument has many functions,
including chemical reagent preheat, magnetic mixing, auto-print and preheat timing.
The standard curves have been stored in the instrument and can be printed out. The
principle of the measurement is to measure the vibration amplitude of small steel ball in
the test slots by electro-magnetic sensors, and through built-in Microprocessor to get
the result of the test. This testing method is not interfered by samples such as original
plasma viscosity, hemolysis, blood lipid and jaundice etc. Because the autopipette is
electronically activated, the error caused by manual pipette is eliminated, and high
accuracy and repeatability of instrument can be ensured.

2.2 Principle of the measurement

C2000-2 coagulation instrument works on the principle of small magnetic ball method.
Via advanced bi-magnetic technique, the instrument measures the changes of vibration
amplitude of the small steel balls in the test cup and then establishes the end point of the
coagulation.
The method used by the instrument is the most advanced, reliable, direct measuring
method at the moment and recognized widely by the world.
The advantage of the instrument are as follows:
a) The interference caused by jaundice in the blood, hemolysis, chylous granules,
turbidity of the reagents may be eliminated. (The indirect measuring method used
by photometric instruments cannot eliminate the above interference directly)
b) The plasma viscosity has no effect on the measurement, because the instrument
only measures the relative changes of the vibration of the small steel balls.
c) Using the same reagent, the ISI-value of the mechanical method is smaller than that
of the photometric method, so that better measuring sensitivity may be obtained by
the instrument.

2.3 Test Items

� PT prothrombin time
� APTT activated partial thromboplastin time
� FIB fibrinogen
� TT thrombin time
� HEP high-molecular-weight heparin
� LMWH low- molecular-weight heparin

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� ProC protein C
� ProS protein S
� thrombin factor II,V,VII,X,VIII,IX,XI,XII estimation

2.4 Features
� All test parameters can be preset according to the customer’s request.
� The present test temperature can be shown by the stabilized temperature controlled
system.
� Preheat system is equipped with sound alert.
� Standard curves can be preset, printed and stored.
� Can be connected with computer.
� Opening reagent system needs only half dosage of the usual reagent for the test.
� High quality Precil test cup and steel ball are provided.

2.5 Main Technical Parameters

2.5.1 Normal Working Condition
(1) Environment condition
Temperature: +100C ~ +300C
Relative humidity: ≤70%
Atmospheric pressure: 86 kPa ~106 kPa
No electro-magnetic interference, no vibration, no conductive dust, no etching
gas.
(2) Main supply: AC 230V, 50Hz
(3) Weight: ≤3.85 kg
(4) Size (L×W×H, in mm): 385×320×140
2.5.2 Temperature
The test can be carried out only after the coagulation analyzer is switched on for
preheating until the experimental temperature reaches 37℃ and is held, with the
preheating time lasting not less than 30 minutes.
2.5.3 Specification
(1) measuring accuracy: ±3%
(2) consistency of channel: 3%
(3) repetition error: ±3%
(4) temperature - controlled accuracy: ± 0.5℃
(5) temperature - controlled stability: ± 0.2℃
(6) Test time: single reagent and single sample ≤500s.
2.5.4 Contraindications
None.

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 3 Installing Your Analyzer

3.1 Introduction
Matching products:
Appellation Requirement Remark
Test cup Precil patent
Steel ball Precil patent
Print paper Match the supply printer
The analyzer system Precil system Optional

3.2 Installation procedure

Make sure to let the instrument on a stable operation table, no vibration and shaky is
permitted.

Figure1 profile of the analyzer

No. Description Explanation
1 Power switch “︱” stand for On；“○” for Off
Voltage:230V;Frequency:50Hz;
2 Power cable port
Specification of fuse: AC 250V F2A
3 Data port RS232

� Connection
(1) Connect instrument to socket.
(2) Pull the one end of data cable in the Data cable outlet of the analyzer, pull the other
end in the RS232 port of computer.
(3) Open your computer and click “setup” program, and then operate as the software
indication.

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 4 Operation

4.1 Introduction

Figure 2 Instrument panorama

Figure 3 Operating Panel

1 Printer cover (Built-in 2 370C reagent–placing 3 370C 4 Liquid crystal

printer) hole with mixing function reagent–placing hole display screen
5 Auto-preheating timing
6 Exit 7 Enter 8 Parameter setup
button
9 Right Arrow 10 Left Arrow 11 Parameter setup 12 Test slots
13 Pre-heating area
15 ball supplying
(4columns, 16 preheat 14 Pipettor hole
device hole
slots)

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� Caution
(1) The reagent placing-hole with“ ”mark has a magnetic field, it is produced by
small magnetic mixing balls for mixing reagent.
(2) Keep the steel ball loader away from magnets. Please use the Precil steel ball and
Precil test cup.
(3) Test cup and steel ball are not to be used more than once.

4.2 Operation
4.2.1 Start menu
Turn on the power switch of the coagulation analyzer, LCD screen will show as figure4,
then it will enter the main menu automatically as figure 5:
Coag. Monitor V x.x
Beijing precil Co.
Precil
TEL: (010)62987758
Figure 4 start menu

--- Precil C2000- T= xx.x

Test Calib Refs
Setup
Figure 5 main menu
Test: Test Calib: Calibration
Refs: Referrences Setup: Setup
4.2.2 Setup
From the main menu, highlight the Setup and press ENT, the screen will display as
below:
Configuration
Prnt = On1 Beep = Tst
Temp_Set= xx.x
Temp_Get= xx.x …
Figure 6 system menu (1)
Prnt: printer
On1 = instant printing Ons = series print Prt =startup Ons off = no printing
Beep: beep
All = all selected (it beeps during loading sample and preheat)
Tst = beep only during loading sample
off = beep off
Temp_Set = set of the test area temperature
Temp_Get= get temperature of the test area

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Select … and press ENT, the screen will display as below:
Configuration
Stir=off
xxxx xx- xx
Figure 7 system menu (2)
Stir: stir
On =startup stir off =turn off stir
xxxx xx-xx: Year month-day；User can set it by yourself.
4.2.3 Refs
From the main menu, highlight the Refs and press ENT, the screen will display as
below:
Refs T=xx.x
PT APTT FIB TT
II V VII X
VIII IX XI XII…
Figure 8 Refs menu (1)
PT: Prothrombin Time
APTT: Activated Partial Thromboplastin Time
FIB: Fibrinogen
TT: Thrombin Time
Thrombin factor II, V, VII, X, VIII, IX, XI, XII estimation
Select … and press ENT, the screen will display as below:
Refs T=xx.x
HEP LMWH ProC ProS

Figure 9 Refs menu (2)

HEP high-molecular-weight heparin
LMWH low- molecular-weight heparin
ProC protein C
ProS protein S
Choose the test item, for example, to highlight PT, and then press ENT, The screen will
display as below:
PT Refs T=xx.x
Units: sec
Incub= 30
Diff= 5% Dupl= No
Figure 10 PT Refs menu
Units :
Sec = second Ratio Ratio_INR % %_INR

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Incub : the time of preheat (units: second)
Diff : differecce
Dupl : duplicate
User can set other items similarly.
4.2.4 Cali
From the main menu, highlight the Cali and press ENT, the screen will display as
below:
Cali T=xx.x
PT APTT FIB TT
II V VII X
VIII IX XI XII…
Figure 11 cali menu (1)
Select … and press ENT, the screen will display as below:
Cali T=xx.x
HEP LMWH ProC ProS

Figure 12 Cali menu (2)

Choose the test item, for example, to highlight PT, and then press ENT，The screen will
display as below:
PT Cali T=xx.x
Lot Data Save

Figure 13 PT cali menu

Lot = input code
Data = input data
Save = calculate and store data
� Lot
Choose Lot and press ENT, the screen will display as below:
Reag_Lot=0
Ctrl_Lot=0
Max = xx.x Min = xx.x
Mean = xx.x ISI = xx.x
Figure 14 Lot menu
ISI= International sensitivity index
Mean= standard sample average time
Cautions:
1) The data is different according to reagent; user can get appropriate value in
reagent manual.
2) The ISI should be imported if results are showed by INR.
� Data

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Choose Data and press ENT, the screen will display Data menu. According to the
units, there are three circs.
a) Sec
If user choose sec as PT units in Refs PT menu, the screen will display as below:
PT Cali T=xx.x
Unit sec need no cali
Any key continue
Figure 15 data menu (1)
b) Ratio_INR and Ratio
If user choose Ratio_INR or Ratio as PT units in Refs PT menu, it is needless to
calibrate.
c) %_INR and %
If user choose %_INR and % as PT units in Refs PT menu, the screen will display as
below:
PT 1 2 3 4 5 6
% 100 80.0 60.0 40.0 20.0 0.00
T1 12.1 13.0 15.0 18.5 30.6 0.0
T2 12.1 13.0 15.0 18.5 30.6 0.0
Figure 16 data menu (2)
Only part of data is showed in screen, user can see others by press .
Cautions:
1) The data in figure 16 is illustrated.
2) The units of items are listed in chapter 5.
d) g/l
Choose the test item FIB, if the unit is g/l or mg/dl, the FIB calib menu will display as
below:
FIB 1 2 3 4 5 6
g/l 5.58 2.79 1.87 1.40 0.70 0.00
T1 9.7 14.8 24.1 31.3 63.1 0.0
T2 9.7 14.8 24.1 31.3 63.1 0.0
Figure 17 data menu (3)
� Save
Choose Save and press ENT, the screen will display Save menu. According to the
units, there are three circs.
a) Sec
If user choose sec as PT units, the screen will display as below:
PT Cali T=xx.x
Lot Data Save
No Calib Needed
Any key continue

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 Figure 18 PT save menu (1)
b) Ratio_INR and Ratio
If user choose Ratio_INR or Ratio as PT units in Refs PT menu, it is needless to
calibrate.
c) %_INR and %
If user choose %_INR or % as PT units in Refs PT menu, the screen will display as
below:
PT Cali T=xx.x
Lot Data Save
R=X.XXXXX
ESC=Quit
Figure 19 PT save menu (2)
R: relative index
Cautions:
1) The instrument will print standard curve and correlation coefficient after confirm
and store standard curve.
2) User can press ESC if it is needless to print data.
4.2.5 Test
� Test preparation
a) Sample processing: using 3.8% sodium citrate solution and whole blood in the
proportion of 1: 9 for anti-coagulation, centrifugal speed 3000/min for 10 minutes,
take the upper layer of plasma for testing.
b) Reagent preparation: please refer the reagent instruction book.
c) Place the test cup within preheat slot and do preheat.
d) Use steel ball loader to load a steel ball in each test cup.
e) Add reagent to the test cup, place it in a 370C hole or room temperature hole, the
steel ball may add to the test cup for mixing if needed.
� Test menu
From the main menu, highlight the Test and press ENT, the screen will display as
below:
TEST T=xx.x
PT APTT FIB TT
II V VII X
VIII IX XI XII …
Figure 20 test menu (1)
Select … and press ENT, the screen will display as below:
Test T=xx.x
HEP LMWH ProC ProS

Figure 21 test menu (2)

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Choose test item and press ENT will enter test menu.
� Reagent and dosage
When test PT, TT, FIB, APTT, some reagents are needed. The dosage is listed (other
test items dosage can reference reagent manual).
Caution: the dosage is referenced to the precil reagents.
item PT TT APTT FIB
Reagent 100 75 50 50
Plasma 50 75 50 10
Cacl2 50
Cushion fluid 90
Note: Units μl
The instrument only uses the half of usual dosage and the accuracy of measurement is
the same as using the usual dosage.
a) Choose the test item: If you choose PT, highlight PT and press ENT, the screen will
display below:
PT sec T = x.xx
01_OK 02_OK
T= T= T=

Figure 22 PT test menu

01: Sample code number; highlight the code number to input the code number of the
patient.
OK: the channel preparation is ready T: Preheat time
b) Add the samples to the test cups, press the preheat slot button A B C
for preheat the corresponding sample, at that time, the timing starts to work and the
signal light turns on. The beep sounds as preheat time is reached. Then move the
test cup from preheat slot to test slot, add the reagent, do the test.
c) When you use the electronic activated sample loader, the timer will start timing
automatically as the reagent added.
d) When you use the manual sample loader, press the button TEST and let the timer
start timing at the time of adding reagent.
e) Finish test and print report as setting.

4.3 Operation of software

The software is optional, if user want to know it, please read software operation
manual.
Note: Any operation problems you can call Beijing Precil Instrument Co., Ltd
+86-010-62963237

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 5 The Expressions of Laboratory Results

5.1 The definition of units

Unit Definition
g/l gram/liter
mg/dl milligram/deciliter
UI/ml International unit/milliliter
Sec second
% percent activity
%_INR percent activity-International Normalized Ratio
Ratio time of sickness/standard time
Ratio-INR time of sickness/standard time-International Normalized Ratio

5.2 The expression mode of the selectable laboratory results

Unit
% %-INR g/l Mg/dl UI/ml Sec Ratio Ratio-INR
Test
PT √ √ √ √ √
APTT √
Fibrinogen √ √ √
Factor II √ √
Factor V √ √
Factor VII √ √
Factor X √ √
Factor VIII √ √ √
Factor IX √ √
Factor XI √ √
Factor XII √ √
Hep √ √
LMWH √ √
ProC √ √
ProS √ √
Thrombin
√
Time
Reptilase
√
Time

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 6 Maintenance and Cautions

6.1 Maintenance
1. Keep clean, keep the test hole cleaning is especially important, anything else is
not permitted to enter the hole.
2. Do not expose the instrument to sunlight and keep the instrument away from
the high temperature.
3. Make sure to let the instrument on a stable operation table, no vibration and
shaky is permitted.
4. Prevent the instrument from moisture and etching; keep the instrument away
from the electro-magnetic interference sources.
5. Power supply is 230V. Be sure to use the stabilizer when the local power source
is not stabilized.
6. To change fuse: the power supply must be cut off during the time of changing
fuse, load the new fuse strictly according to the specification shown on the side
of fuse box (the specification of fuse is 2A/250V/20mm).
7. is a mark of connecting earth.

6.2 Cautions
1. To prevent accident risk, the socket must be really earthed during turning on the
instrument.
2. To insure the accuracy of the test, the instrument must be preheated as indicated
on the screen before operation.
3. The instrument is a high precision, high accuracy unit; it must be placed on a
stable operation table for test.
4. Do not expose the instrument to direct sunlight and keep the instrument away
from strong heater.
5. Keep both the instrument and steel ball loader far from the interference source of
strong electro-magnetic field.
6. Do not detach and check the instrument without the agreement of maintenance
engineer.
7. To insure the high accuracy of test, it is important to use one-shot test cup and
one-shot steel ball produced by Precil.

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 7 Storage and Transport

7.1 Storage
Be sure to store the instrument in a room with the temperature of -20℃～55℃, the
relative humidity of 93%, no etching gas, and having good ventilation.

7.2 Transport
Please put the instrument in precil container when it is removed.

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 8 Disposal of Castoff

The plasma used in test should be disposed according to the local law. The waste
liquid contains biological and chemical composition; it is strongly recommended that
gloves should be wearied before use the instrument. Used test cup should be treated as
iatrogenic waste.

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 Appendix1 Precil Test Cup and Steel Ball

The test cup and steel ball are precil patents, which are match up to C2000 series
coagulation analyzers. The material of test cup is polystyrene, which has
characteristics safety, convenience, and high accuracy of test. The steel ball is made up
of stainless steel and wiped off magnetism.
1 Configuration and Capability
1.1 The capability ≥400μl, the exterior of test cup should be transparent, having no
nick, no bladder.

Figure 23 Test cup

1.2 The exterior of steel ball should be glabrous.

Figure 24 steel ball

2 Use
a) Add steel ball and plasma to test cup, then move it to preheat slot until reach a
steady temperature.
b) Operate instrument to test menu.
c) When the time is up, move test cup to test area and add reagent vertically using
sample loader
d) Operate instrument to test sample.
3 Cautions
a) If choose manual sample loader, you need to use it add preheated reagent into
sample test cup.
b) Test cup and steel ball are one-off production.
c) One side of cup has the word precil.
d) Four cups are connected together, user should disjoin them.
4 Storage
Be sure to store the test cup and steel ball in a room with no etching gas and having
good ventilation.

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