Product Registration No.: JINGYAOJIANXIE(APPROVAL) No.

___
Product Standard No.: YZB/JING 0839-2010
Production License No.: JINGYAOJIANXIE Production License No. 20030106

Instruction Manual: SF-400 Semi automatic

Coagulation Analyzer

Read this manual before operation.

 Beijing SUCCEEDER Technology Development Co., Ltd

Contents
Thank you for your purchase of our instrument! ........................................2

Significations of the SF-400 Signs ........................................................3

☆ Important Safety Instruction .............................................................3

Anticipated Usage ....................................................................................4

Brief Introduction ......................................................................................5

2 Test Principle .........................................................................................7

3. Installation .............................................................................................8

4 Basic Functions and Operation Guide ..............................................8

5 instrument settings and operation guide ...........................................9

6. Test Result Presentation Method ....................................................17

7. Maintenance method.........................................................................18

8 Maintenance for and Elimination of Common Failures ................19

9. Coagulation Instrument Installation Process .................................20

10. Brief Instruction for the Coagulation Instrument Operation ......21

11. Calibration Method ..........................................................................22

12. Manufacturer's Setup ......................................................................22

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 Thank you for your purchase of our instrument!

Read this manual carefully before using this instrument！

Product：Semi automatic
Specification：SF-400
Coagulation Analyzer

Produced by Beijing SUCCEEDER Technology Development Co., Ltd

After-service and maintenance special line（free）：Tel: +86-10-89711711/89701211/1311

Fax： +86 -10-89701711
Company Address： Tower 1A No. 27 Chuangxin Rd. Tech. Park Changping District Beijing PRC-102200
http://www.succeeder.com.cn
E-mail：service@succeeder.com.cn

If you have purchased our instrument from an authorized agency, please remember the contact
information of the agency！

Agency：

Tel：

Fax：

Address：

Please record the following information and inform us after your installation so that we establish an
archive for you and provide you more and better service and communication！

User Name：

Laboratory Name：

Instrument No.： Operator：

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 Significations of the SF-400 Signs

Biological Hazard – means that the rejected material is biologically

dangerous, please dispose it in light of the local laws and regulations.

Warning – You must operate as instructed in case personal injury.

☆ Note – means important information for operation or maintenance and useful

instructions.

Caution – danger, person in charge or operator should check up the instruction

manual.

☆ Important Safety Instruction

Before installation and the first operation of the instrument, please read all of the following
instructions. The instrument must be operated in accordance with this instruction manual.
Operation without following the instruction may damage the safety protection system.
SUCCEEDER Co., Ltd will not take the responsibility for any loss out of any operation not
complying with this manual or any operation procedure not specified in this manual.

 The grid power must have an earth point for protection. The instrument internal safety
protection earth terminal is signed with and ought to be soundly grounded through
power line socket. The grid power input socket is a switch between the equipment and the
power supply and should not be installed in a place difficult to disconnect to the grid power.
Install a leakage protector when operating in possibly humid places.
 The data plate on the instrument indicates the name, model number, producer, manufacture
number, rated power supply voltage, power supply frequency, and input power of the instrument.
 The exterior sign of indicates that the instrument should be operated by the operator, and
operated as thoroughly instructed in the manual by all means.
 All our instruments are protected with appropriate facilities in transportation; generally the
instruments shall not be moved after installation and operation. Please pay special attention.
 Unless it is instructed, please do not open and check in case risk of high voltage or other
hazards. Leave the internal part checkup and repair to professional maintenance staff.

Please carefully read the potential contamination warning regarding all biological products

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 (reagent, calibration material, quality control plasma and patients’ plasma):
 Do not eat, drink or smoke in any place where a biological product is used;
 Wear disposable gloves when using biological products;
 If a biological product contacts a wound on your skin or your mucous membrane, flush it
with running water immediately and see a doctor;
 Dispose all used biological products in accordance with the local laws and regulations (for
example, heating for sterilization, burning, or dispose liquid waste with sodium
hypochlorite).
 Our instruments are designed for indoor use except those for special purposes.
a） No strong electromagnetic interference, no severe shake, no corrosive gas near the instruments;
b） Indoor temperature（10～30）℃；relative humidity not higher than 70％；atmospheric pressure
（86.0～106.0）kPa；
c） Avoid humid environment；
d） Preservation condition for sound package – indoor, and -40～55 ℃，relative humidity not higher than
93%，no corrosive gas, proper ventilation;
e） The earth point of the power cord must be reliably grounded through the power socket. Use leakage
protector when using the instrument in places with possible humidity.
f） All our instruments are equipped with internal voltage regulators and need no external voltage
regulator. Only when external power supply voltage fluctuations exceed（220±22）V, you may use
UPS type voltage regulators instead of those of common types.
 Please shut off the power, put off the power plug and leave it to a professional under the following
circumstances:
a) A power cord, a data line, or a plug damaged or broken;
b) The instrument exposed to rain or water；
c) The instrument broken or its case broken；
d) The instrument does not work in a normal way when operated as instructed in the manual；
e) If the feature of the instrument is changed significantly and cannot be resumed with elimination of
any error of sample, affiliated device or human operation, the instrument needs repair, please
contact the after-service staff for the instrument.

Anticipated Usage

SF-400 semiautomatic Coagulation test instrument is an apparatus making use of 220V civil power

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supply. It is applicable in hospitals at various levels and in medical science research institutions for
testing coagulation function of plasma using coagulation method.
We make sure that every instrument produced by us tested and checked by a strict standard. SF-400 is
up to the national standard, industry standard and registered product standard.
Up to now no contraindication is found.
This instruction manual shall be delivered along with the instrument.

This instrument is used only for extra-corporal diagnosis.

Brief Introduction

SF-400 coagulation instrument bears the functions of reagent pre-warming, magnetic

stirring, automatic printing, temperature accumulation, timing indication, etc. The
benchmark curve is stored in the instrument and the curve chart can be printed. The
testing principle of this instrument is to detect the fluctuation amplitude of the steel beads
in the testing slots through magnetic sensors, and to get the testing result by computing.
With this method, the test will not be interfered by the viscosity of the original plasma,
hemolysis, chylemia or icterus. Artificial errors are reduced with the use of electronic
linkage sample application device so that high accuracy and repeatability guaranteed.
This product is suitable for detection of blood coagulation factor in medical care, scientific
research and education institutions.

1.1 Components
Sheet 1 Model and Components
Model Components Optional Parts Optional Channel
Software Number
SF400 Coagulation 4
instrument host,
mini-printer
(fixed inside)

1.2 Basic Parameters

1.2.1 The tester's external dimension:
l × w × h:390 × 400 × 135(mm × mm × mm).
1.2.2 Weight: 15kg.
1.2.3 Reagent Slot Number: 4 (1 of which has the function of reagent stirring).
1.2.4 Pre-Warming Slot Number: 16
1.2.5 Test Channel Number: 4

1.2.6 Start-Up Warming-Up Period: 30min

1.3 Conditions for Preservation and Normal Operation

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1.3.1 Operation Environment Condition
a) Temperature: 10 ℃ -30 ℃
b) Relative Humidity: ≤ 70%
c) Atmospheric Pressure: 700hPa ～ 1060hPa
d) No strong electromagnetic interference, no shock, no conductive dust, no
corrosive gas.

1.3.2 Power Requirement:

Alternating voltage 220V; frequency 50Hz

1.3.3 Preservation and Transportation Condition:

a) environmental temperature -20 ℃ ～ 55 ℃
b) relative humidity not exceeding 93%
c) no corrosive gas, appropriate ventilation
d) carefully guard against collision, extrusion pressing, throwing, shock, rain,
exposure to moisture or solarization

1.4 Performances
1.4.1 Accuracy: ± 3%
1.4.2 Channel Consistency: 3%
1.4.3 Repeatability Error: not higher than 3%
1.4.4 Temperature Accuracy: ± 1 ℃
1.4.5 Temperature Stability: ± 1 ℃
1.4.6 Testing Time: ≤ 500s
1.4.7 Self-test function should be normal, and the function menu should be
displayed.
1.4.8 Basic Functions:
After start-up, the following functions shall be available:
a) Display of the present environmental temperature;
b) Setups for and indications of warm-up periods 0s~999s based on the different purposes
and reagents of the test;
c) Automatic generation of test report, printing and producing test report according to
user's setups;
d) Pre-selection of channels.

1.5 Operation Panel

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Note:
1. The reagent hole signed with △ has magnetic stirrer’s magnetic field for function
of mixing the reagent well.
2. The bead application device should be kept away from the magnetic field.
3. The coagulation cups and the beads should not be reused in case severe
interference for test result.

1.6 Test Items

a) PT: prothrombin time
b) APTT: activating part blood coagulation activation enzyme time
c) FIB: fibrinogen
d) TT: thrombin time
e) HEP: high molecular weight heparin
f) LMWH: low molecular weight heparin
g) Pro C: protein C
h) Pro S: protein S
i) II, V, VII, X, VIII , IX , XI , XII blood coagulation factor test

2 Test Principle

Tests by SF-400 Coagulation instrument make use of the magnetic beads. The instrument
measures the motion amplitude change of the steel beads in the detection cups through
the advanced double magnetic circuit detection system to determine the coagulation
endpoint. Among tests of coagulation method, this is an internationally accepted
advanced and reliable direct detection method. Its advantages are as follows:
a) being able to eliminable the interferences caused by icterus in blood, hemolysis, chyle

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particles opacitas and the turbidity of the reagent itself (instruments functioning with
photographic turbidimetry are for indirect detection without directly eliminating the above
interferences).
b) Detecting the relative change of the steel bead's motion, it is not influenced by viscosity
of blood plasma.
c) By use of the same reagent, the ISI value of the mechanical method (Mech) is less than
that of photographic method (Photo), and so the Mech method can achieve higher
detection sensitivity.
d) Having wider linear ranges, for example, a linear range of fibrinogen 0.5-12 / l.

3. Installation

3.1 Put the instrument on a flat and firm workbench.

3.2 Line Connection

Plug one end of the host power cord into the host power point, and the other end into the
power line outlet (to ensure safety, the socket ground wire should be reliably grounded).

3.3 Equip the instrument with communication wire connected to the hospital LIS
system.
The communication wire should be connection wire RS232, and should directly connect
the SF-400 semiautomatic Coagulation test instrument to the hospital LIS system
computers. The firmware program in CPU of the test instrument supports the LIS system
to read the test data.

3.4 Start-up Check

Establish the power, and turn on the host power switch. Then the host liquid crystal
display (LCD) window should display in full.

3.5 Safety Statement

3.5.1 Never put the bead application device into the poking hole, and never put it into the
adjacent hole in case the bead being magnetized.
3.5.2 Use the disposable test cup produced by the manufacturer and the disposable steel
bead offered by the manufacturer to ensure the measuring accuracy.
3.5.3 Peripheral Equipment pieces such as computer and printer, being the necessary
equipment for the functions of the product, should be connected to the power line
separately, and should be conformed to relevant safety standard. We are not including
such items in this manual.

4 Basic Functions and Operation Guide

4.1 Function of Displaying the Environmental Temperature of Current Test:

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The current test environmental temperature can be displayed in the main menu,
parameter menu, system menu, calibration menu and test menu.

4.2 Function of Setting and Indication of Warm-Up Periods of 0s~999s Based on the
Different Purposes and Reagents of the Test:
The warm-up time can be set in the parameter menu. The temperature control coefficients
and sample application buzzer sounds can be set in the system menu.

4.3 Function of Automatic Generation of Test Report, and Printing and Producing
Test Report According to User's Setting:
The print setup can be done in the system menu.

4.4 Function of Pre-Selection of Channels

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5 instrument settings and operation guide

5.1 Start-Up Menu and Main Menu

5.1.1 Start-Up Menu: Establish the power, turn on the power switch, and the start-up
menu will be displayed in the LCD window,
See figure 5. 1.1a), SF-400

SF-400 Semiautomatic coagulation Instrument Vx.xx

Figure 5.1.1 a) SF-400 Start-Up Menu

5.1.2 Main Menu: after the display of the start-up menu, the main menu can be entered
automatically as shown in figure 5. 1.2 a)

-SF-400- T=x.xx

Test Calibration Parameter System

Figure 5.1.2 a) SF-400 Main Menu

5.2 System Menu and Setup Guide

5.2.1 System Menu: in the system menu, the operator can select and set the report
printing type, the buzzer sound, the temperature coefficient and current time.
A) Report printing type selection setup:
i. Instant printing: with this item selected, instant printing will be carried out after every
experiment;
ii. Batch printing: with this item selected, the results will be stored in the instrument after

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a batch of experiments and will be printed with the order of "start up batch printing";
iii. Start up batch printing: first, select "batch printing", and after the batch of
experiments, select this item and the results of all this batch of experiments will be printed
by the sequence of their test serial numbers.
iv. Shut up printing: with this item selected, the instrument will not print the experiment
results; if, at first, the "batch printing" is selected, and after experiments the "shut up
printing" is selected, then the "start up batch printing" order will fail.
b) Buzzer sound selection: indication sounds for the sample application and
pre-warming completion can be selected.
c) Coefficient of temperature setup: this item is debugged and set by manufacturer's
professional staff, and users are not expected to modify it.
d) Stirring setup: the operator can set up by this item whether the reagent be stirred in
the marked reagent hole by magnetic stirring operation. The marked reagent hole is only
for reagents need to be stirred while the bead application device or beads are not allowed
in this hole.
e) Current time setup: the manufacturer's setup can be modified to the current time.

5.2.2 Setup Method

Use the left and right cursor key to move the cursor in the main menu, and select "system",
then press OK to enter the system menu, as shown in figure 5. 2.2 a)

System Parameter T=x.xx

Printing=xxx Buzz=xxx Stirring=xx
Temperature Parameter 1=x.xxx Temperature Parameter 2=x.xxx
xxxx xx-xx xx:xx:xx Lightness

Display Notes:
Printing =xxx: There are four options in this item:
=On1: printing;
=Ons: batch printing;
=Prt: start up batch printing;
=Off: shut up printing.
Buzzer=xxx: there are three options in this item;
=All: select all, buzzers for both sample application and pre-warming;
=Tst: buzzer only for sample application;
=Off: buzzer shut up.
Stirring =xxx: there are two options in this item:
=On: turn on the stirrer;
=Off: turn off the stirrer.
Coefficient of temperature 1 and coefficient of temperature 2
Coefficient of temperature 1: coefficient of temperature of test area;
Coefficient of temperature 2: coefficient of temperature of reagent pre-warming area.
xxxxxx-xxxx:xx:xx: current time, year month day hour min sec users can set up at their

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own discretion.
lighteness: LCD panel dimmer control, ↑ = increase lighteness; ↓ = decrease
lightness.
T=xx.x: current instrument temperature display, the same bellow.

Notes
1. Users can select and set up printing and buzzer based on their demands and can
modify the year/month/day/time.
2. coefficients of temperature should be debugged and set by manufacturer's
professional staff, and users are not expected to modify it.

5.3 Parameter Menu and Setup Method

5.3.1 Parameter Menu: users can select and set up various parameters in the parameter
menu including unit select setup, sample warm-up period selection setup, single/double
sample setup, etc.
a) Unit Select Setup: setup for selection of test result report unit. There will be different
menus and indications for different options of report unit when calibrating the setup for
input.
b) Sample Warm-Up Period Selection Setup: different reagents, or different
manufacturers' reagents, will need different sample warm-up periods. The related
parameters are provided in the specifications of the reagents, for example:
item PT APTT TT FIB
pre-warming 60 180 60 120
time
Note:
Unit: Sec, this table is for reference only, and the actual parameters provided in the
specifications should be deemed standard.

c) Setup for Single/Double Sample: the single or double of test samples can be selected, if
a user selects double samples, he/she can set up the test deviation item.

5.3.2 Setup Method

Use the left and right cursor key to move the cursor in the main menu, and press OK on
"parameter" to enter parameter menu, as shown in figure 5. 3.2a),

Parameters T=xx..x
PT APTT FIB TT
Ⅱ Ⅴ Ⅶ Ⅹ Ⅷ Ⅸ Ⅺ
Ⅻ HEP LMWH ProC ProS

Figure 5.3.2 a) SF400 Parameter Menu

Display Notes:
PT: prothrombin time test item

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APTT: test item for activated partial thromboplastin time
FIB: fibrinogen test item
TT: thrombin time test item
Ⅱ Ⅴ Ⅶ Ⅹ Ⅷ Ⅸ Ⅺ Ⅻ: blood coagulation factor measuring test item
HEP: high molecular weight heparin test item
LMWH: low molecular weight heparin test item
Pro C: protein C test item
Pro S: protein S test item

5.3.2.1 PT Parameter Menu

Use the cursor key to move the cursor in the parameter menu, select "PT", then press OK
to enter PT parameter menu, as shown in figure 5. 3.2.1:

PT Parameter
Unit Select=sec
Warm-Up 1=180 Warm-Up 2=180
Deviation=5% Double Samples =No
Figure 5.3.2.1 PT Parameter Menu
Display Notes:
Unit select: there are five options in this item - Sec, %-INR, %, Ratio-INR and Ratio, users
may select the current test result report unit based on their demands [refer to test result
presentation method for details].
Warm-up 1: the first pre-warming period, manufacturer's setup is 180, and users can
modify it based on their demands.
Warm-up 2: the second warming-up period, manufacturer's setup is 180, and users can
modify it based on their demands.
Deviation: with double samples, the instrument detects the deviation between the samples
automatically and indicates with "%". An asterisk "*" will be put before the printed average
value of the results when the calculated value is higher than the setup maximum deviation
value. The manufacturer's setup is 5%, and users can modify it based on their demands.
Double samples:
No= single sample test, Yes= double sample test

5.3.2.2 Other Parameter Menu

Use the cursor key to move the cursor in the parameter menu, select "other parameter",
and then press OK to enter other parameter menu. The operation guide is the same as
that of PT parameter menu.

5.4 Calibration Menu and Setup Method

Use the left and right cursor key to move the cursor in the main menu, select "calibration",
then press OK to enter calibration menu, as shown in figure 5. 4. a),

Calibration T=xx..x
PT APTT FIB TT
Ⅱ Ⅴ Ⅶ Ⅹ Ⅷ Ⅸ Ⅺ
Ⅻ HEP LMWH ProC ProS
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 Figure 5.4 a) SF400 Calibration Menu
Use the cursor key to move the cursor in the calibration menu, select "PT", then press OK
to enter PT calibration menu, as shown in the figure

PT Calibration T=xx.x
Batch Number Input Calculation
PT Calibration Menu
Display Notes:
Batch number: batch number menu for input of batch number;
Input: input menu for input of data;
Calculation: calculating menu for calculating and saving data.

5.4.1 Batch Number Menu

Use the cursor key to move the cursor in the PT calibration menu, select "batch number",
then press OK to enter batch number menu, as shown in the figure

Reagent batch number=xxxxxxx

Standard product batch number=xxxxxxx
Upper limit=xx.xx lower limit=xx.xx
Standard value=xx.xx ISI=x.xxx
Batch Number Menu
Display Notes:
Standard value: standard substance time ISI: international sensitivity index
Upper limit: normal reference value upper limit lower limit: normal reference value
lower limit
Attention:
Setup values higher than 4 may vary according to users' different reagents. Refer to the
above nominal values in the reagent specifications.
For value 5, when you present it with INR, input the ISI value, then confirm and press
"Exit" key to exit.

5.4.2 Input Menu

Use the cursor key to move the cursor in the PT calibration menu, select "input", then
press OK to enter input menu. In accordance with the selected unit, the input menu may
be shown as the following three options:
a) Sec unit
in the PT parameter menu, select the unit "sec"; in the PT calibration menu, move the
cursor with the cursor key, select "input", then press OK to enter "sec" unit input menu,
as shown in figure 5. 4.2. a):

PT Calibration T=xx.x
Unit sec, no need for calibration press any key to continue

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 Figure 5.4.2. a) “Sec” unit input menu
b) Ratio_INR and Ratio unit
In the PT parameter menu, select the unit as "Ratio_INR" and "Ratio"; no need for rating
data, press "Exit" key to exit.
c) %_INR unit
In the PT parameter menu, select the unit "%_INR"; move the cursor with cursor key in the
PT calibration menu, select "input", then press OK to enter "%_INR" unit input menu, as
shown in figure 5. 4.2.b):

PT 1 2 3 4
% 100 80.00 60.00 40.00
T1 12.10 13.00 15.00 18.50
T2 12.10 13.00 15.00 18.50
Figure 5.4.2. b) “%_INR” unit input menu

If you need to input 100 in the input menu, input 99.99 first, then press the " ∧ " key to
reach 100.
After input of the standard curve value of the activity, press "Exit" to exit the menu.

Attention:
1. Data in the figure are examples;
2. Refer to "test result presentation method" for units of parameters.

5.4.3 Calculation Menu

In the PT calibration menu, move the cursor with the cursor key, select "calculation" to
enter calculation menu. The calculation menu may show the following three options in
accordance with different unit selections.
a) Sec Unit
In the PT parameter menu, select the unit "sec"; in the PT calibration menu, move the
cursor with the cursor key, select "calculation" then press OK to enter "sec" unit
calculation menu, as shown in figure 5. 3.6

PT Calibration T=xx.x
Unit sec, no need for calibration press any key to continue

Figure 5.3.6 “sec” unit calculation menu

b) Ratio_INR and Ratio Unit
In the PT parameter menu, select unit "Ration_INR" and "Ratio"; no need for rating data,
press "Exit" key to exit.
c) %_INR Unit
in the PT parameter menu, select unit "%_INR"; in the PT calibration menu, move the
cursor with the cursor key, select "calculation", then press OK to enter "%_INR" unit
calculation menu, as shown in figure 5 . 7.1

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 PT Calibration T=xx.x
Corresponding Coefficient=-x.xxxxx
Exit key = Give Up

Figure 5.7.1 “%_INR” unit calculation menu

Attention:
5. If you need to confirm and save the standard curve, press OK, then the
instrument will automatically print the standard curve data and related coefficients.
6. If you don't need to print the date, press "Exit" key to exit. 5.5 other item
calibration menu

In the calibration menu, move the cursor with the cursor key, select other parameter, and
then press OK to enter other parameter menu. The operation method is the same as that
of PT calibration menu.

5.6 Test Menu and Trial Operation Method

5.6.1 Experiment Preparation

a) Sample processing: adopt 3. 8% Natrium Citricum Solution (2Na3C6H5O7o11H2O)
and whole blood 1:9 for anticoagulation, centrifugal speed 3000 revolutions per minute, 10
minutes, take the upper layer blood plasma for use;
b) Reagent preparing: refer to reagent specification;
c) Put the test cups in the pre-warming slots to pre-warm;
d) Put a steel bead in each of the test cups with bead application device;
e) Put the reagents in relevant positions, 37 ℃ hole or room temperature hole, put it into
the stirring hole if needs to be stirred.

5.6.2 Enter the Test Menu to Select Test Item

In the main menu, move the cursor with the cursor key, select "test", then press OK to
enter test menu. Move the cursor with the cursor key, select the test item, then press OK
to enter the corresponding item's test menu.

5.6.3 Test Sample and Reagent Quantity

Generally used blood coagulation 4 index (PT, TT, FIB, APTT) reagents and blood plasma
normal sample quantities are as follows (refer to the reagent specifications for other
factors):
Item PT TT APTT FIB
reagent 100 100 50 50
blood plasma 50 100 50 100
CaCl2 50

Note:

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unit: ul
In this case Succeeder Reagent is used as an example.

5.6.4 Test Measurement

5.6.4.1 PT Test Menu

in the PT parameter menu, select the unit "sec"; in the test menu, move the cursor with the
cursor key, select the test item "PT",
Then press OK to enter PT test menu, as shown in figure 5. 6.4.1a):

PT sec T=xx.x
01_ 02_ 03_ 04_
T= T= T= T=
Figure 5.6.4.1 a) SF400 Test Menu

Display Notes:
01-04: sample code, move the cursor, select the channel, move the cursor up and down to
modify the patient code, 1-100 are available, and the codes will be automatically
accumulated after each test.
T: display of pre-warming time

5.6.4.2 Put the specimen into the test cup, press the corresponding key of the
pre-warming slot, timing is started up, and a beep will be made to give indication when
pre-warming time is up. Then move the test cup from the pre-warming slot to the test slot,
apply the reagent and do the test.

5.6.4.3 When a linkage sample application device is used, the instrument will
automatically start up the timer to begin the timing as soon as the reagent is applied.

5.6.4.4 When a manual sample application device is used, the operator should press
"test" key as soon as the reagent is applied to start up the timer.

5.6.4.5 When the test is completed, the Test Report will be printed according to the setup.

16
 Note: Connection between linkage sample application device and the test instrument –
put the linkage plug of the linkage sample application device into the pipette socket in the
right side of the test instrument.

6. Test Result Presentation Method

6.1 Units and Definitions of test results

Unit Definition
g/l gram/liter
mg/dl milligram/deciliter
IU/ml international unit/milliliter
Sec second
% percentage activity
%-INR percentage activity – international normalized ratio

6.2 Test Result Presentation Method

Unit % %-INR g/l Mg/dl IU /ml Sec Ratio Ratio-INR
selection
experiment
Percentage percentage gram/liter milligram/deciliter international second Patient Patient
activity activity – time/st time/standard
unit/milliliter
international andard time –
normalized time international
ratio normalized
ratio
PT √ √ √ √ √
APTT √

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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

Note: " √ " means that the current unit can be adopted in the current test.

7. Maintenance method

7.1 Environment:
Keep clean, and it is of special importance to keep the interior of the testing holes
clean. Absolutely avoid any foreign material in the holes. Avoid exposure to moisture,
corrosion or strong electromagnetic field interference source. Use dry and soft cloth to
clean the surface of the instrument, and use no disinfectant containing strong acid or
strong alkali for cleaning the surface of the instrument.

7.2 Placement:
The instrument should be placed on a firm workbench without any shake or shock.
Avoid exposure to straight sunshine, and keep away from source of strong heat.

7.3 Power Source Voltage:

Voltage: 220V, Frequency: 50Hz. If the local power voltage is unstable, use regulated
power supply. Input power: not higher than 100(1 ± 15%) VA (W), and not combined to the
same power line with any high-power electric appliance.

7.4 Fuse Replacement:

When replacing the protective tube in the fuse, turn off this system and put off the
power cord, and replace with a model precisely conformed to the specification labeled
beside the fuse base (fuse specification: 2A/250V/20mm).

7.5 the △ Mark Inside the Instrument

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Warning for users: heating device in it, constant temperature 37 ℃ ± 1 ℃, please do not
touch with power on.

7.6 Mark △ on the Instrument Panel

Warning for users: bead application device is strictly prohibited from being put into the
stirring hole, and never put it into the adjacent hole in case the beads being magnetized.

8 Maintenance for and Elimination of Common Failures

Statement:
If the operation of the instrument is abnormal, please solve it as instructed bellow, and if
you cannot solve it or if the problem is other than those described bellow, please contact
our after-sale service department immediately and deal with it under the instruction of our
professional staff.

Trouble Phenomenon 1: some of the 4 Coagulation conventional indexes are

normal, and some are abnormal
Operational Error - check your operation process step by step in accordance with the
instruction manual to rectify your operation.
Reagent Problem - check the quality of your reagent and replace it.

Trouble Phenomenon 2: poor consistency of test results, and failure to reach to

standard
Sample application problem - improve your sample application accuracy and operate with
high proficiency.

Trouble Phenomenon 3: FIB curve and R-value are excessive

Inaccuracy in diluting the blood plasma for calibration - non-standard operation,
inaccurate sample application, value less than 0 .98 recast the standard curve.

Trouble Phenomenon 4: abnormal temperature display

Display room temperature with no need to warm up
Display temperature higher than 40 ℃
Check the power or the triode and replace if anything is damaged

Trouble Phenomenon 5: display of normal temperature with actual temperature

higher than 37 ℃
Inappropriate temperature coefficient setup, see the temperature label and check, reset
the temperature coefficient according to the manufacturer's parameter.

Trouble Phenomenon 6: No reaction to press of keys

The mask line is of poor contact, or the key (s) damaged, mask needs to be replaced.

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Trouble Phenomenon 7: no reaction pressing sample application gun
Check the connection cord to see whether there is any poor contact or disconnection.

Trouble Phenomenon 8: loud noise from reagent stirring slot

Improper position of stirring motor magnet bracket - readjust the stirring bar position.

Trouble Phenomenon 9: no display at start-up

Disconnection of power cord, safety fuse tube burnout, or rectifier bridge damage.
Power supply chip damage

Trouble Phenomenon 10: measured FIB value generally on the high side or on the
low side
Standard curve incorrect, remake the standard curve.

9. Coagulation Instrument Installation Process

9.1 Preparation
a. check the packing list before installation to see if the components delivered in full
set.
b. identify and confirm the Coagulation reagent with the user, and if the reagent is
provided along with the instrument, check if it is safe (if delivered with CaCl2), and check
the reagent's period of validity.
c. check if the power supply of the instrument is safely grounded.

9.2 Installation
a. Open the package;
b. Check packing list together with the user's staff, and prove the checked
components with the packing list.
c. Connect the power supply and the linkage gun as required, turn on the instrument
and pre-warm it to 37 ℃.
d. Input parameters: enter the system and see if the setups are correct and input
parameters, and input parameters according to reagent requirements (maximum reaction
time, maximum pre-warming time, unit, single or double samples), and enter the
calibration menu to input reference range, ISI value is required for PT.
e. Make up the reagent and prepare the reference blood plasma. Add distilled water
to re-dissolve and wait 10-15 min for dissolving as required.
f. Work out the FIB curve, dilute the reference blood plasma by dilution ratios of 1:5,
1:10, 1:15, 1:20, 1: 40, dilute 4 times by each ratio, and work out the average time. Input
the data, save the data. Compute the R-value. R-value of imported reagents is around
0.99 in general. R-value of reagents made in China may be lower. In the case of a
reagent made in China, re-make it on the installation site as far as possible.
g. Test: if a quality control sample (normal blood plasma) is available for an
experiment, check if the experiment result is within the acceptable target value range. If
the result is acceptable, let the user see and confirm.

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 h. Sign the acceptance certificate: let the user sign on the acceptance certificate after
the completion of above procedure.
Training: train the user's staff with reference to the operation instruction, and
emphasize the notes and precautions.

10. Brief Instruction for the Coagulation Instrument

Operation

10.1 Preparation:
Turn on the instrument and wait for the temperature to rise to 37 ℃.

10.2 Preparation of Specimen:

Take vein blood sample, use 3.8%(2Na3C6H5O7 •11H2O) or 3.2% (NaC6H5O7 •2H2O)
solution along with whole blood by 1:9 as anticoagulant, centrifugal speed 3000
revolutions per minute, 10 minutes, take the upper layer blood plasma for use.

10.3 Reagent Preparing:

Please refer to the reagent specification, after dissolving, put the reagent into the relevant
position of the instrument, the 37 ℃ hole or room temperature hole, put into the stirring
hole if it needs to be stirred.

10.4 Specimen Test:

A . Prothrombin Time Measuring (PT)
Put the test cups into the pre-warming slots and pre-warm them, put a steel bead into
each test cup using the bead application device, take 50μl blood plasma and put into the
test cups, press the corresponding pre-warming keys to pre-warm the specimens. With
the pre-warming done, move the test cups from the pre-warming slots to the test slots,
add 100μl PT reagent into them using the linkage sample application gun, and the
instrument will automatically time and print the report. The SEC, Ratio and INR values
may be reported.
B. Activated Partial Thromboplastin Time Measuring (APTT)
Put the test cups into the pre-warming slots and pre-warm them, put a steel bead into
each test cup using the bead application device, take 50μl blood plasma and 50μl APTT
and put them into the test cups, press the corresponding pre-warming keys to pre-warm
the specimens. With the pre-warming done, move the test cups from the pre-warming
slots to the test slots, add 50μl 0.025Mol/LCaCl2 reagent using linkage sample application
gun, and the instrument will automatically time and print the report to deliver SEC value.
C. Thrombin Time Measuring (TT)
Put the test cups into the pre-warming slots and pre-warm them, put a steel bead into
each test cup using the bead application device, take 100μl blood plasma and put it into
the test cups, press the corresponding pre-warming keys to pre-warm the specimens.
With the pre-warming done, move the test cups from the pre-warming slots to the test
slots, add 100μl TT reagent with linkage sample application gun, and the instrument will
automatically time and print the report to deliver SEC value.

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D. Fibrinogen Content Measuring (FIB)
Put the test cups into the pre-warming slots and pre-warm them, put a steel bead into
each test cup using the bead application device, dilute the blood plasma by 10 times with
buffer solution, take 100μl diluted blood plasma and add it to the test cups, press the
corresponding pre-warming keys to pre-warm the specimens. With the pre-warming done,
move the test cups from the pre-warming slots to the test slots, add 50μl FIB reagent with
linkage sample application gun, and the instrument will automatically time and print the
report to deliver SEC, g/l, mg/ml values.

10.5 Remarks:
A. Before the test, input the required parameters as specified in the reagent specification,
ISI value is a must for PT.
B. The use of a steel bead in a test must be one-off, and the beads should be kept away
from magnetic field.
C, After a change of the batch number of fibrinogen reagent, it is better to re-make the
standard curve. Refer to the instrument instruction.
D. Contaminated distilled water is not allowed for use of diluting reagents.
E. For dissolution of reagents, the powder on the bottle cap must be dissolved in the bottle
instead of being dropped out of the bottle.

11. Calibration Method

11.1 Measuring:
Take the calibration blood plasma, re-dissolve as required, and dilute the blood plasma
with imidazole buffer solution by 5 times, 10 times, 15 times and 20 times, take 100μl
respectively from each of the dilutions, pre-warm them for 1 ～ 3min, to 37 ℃,
respectively add 50μl FIB reagent to each of them, and record the coagulation times.

11.2 Production of Graphs and Calculation

Take the fibrinogen content as the abscissa, and coagulation times as the ordinate, and
draw the graph on double logarithmic paper; or make use of Excel software to carry out
the regression treatment and produce the graph, and get the regression equation and
correlation coefficient.

11.3 Calibration:
Take the 10 times dilution as 100%, input the fibrinogen contents and the corresponding
coagulation times into the Coagulation instrument in sequence, and the test system
calibration is done.

12. Manufacturer's Setup

Enter the system, alter the time to 2188, and press the OK key, then the parameters of the
system will be set as the manufacturer's default values. After the resetting the options to
default, alter the time of the system to the current time.

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