SF-8050 Automatic Coagulation Analyzer Manual

SF-8050 Automatic Coagulation Analyzer

Instruction Manual

Beijing SUCCEEDER Technology Development Co., Ltd

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 SF-8050 Automatic Coagulation Analyzer Manual

CONTENT
1. REFERENCES .................................................................................................................. 6
1.1 INSTALLATION .................................................................................................................. 6
1.1.1 Installation requirements............................................................................... 6
1.1.2 Installation procedure ........................................................................................ 6
1.1.3 Connecting peripherals ..................................................................................... 6
1.2 INSTRUMENT INTRODUCTIONS ........................................................................................... 7
1.2.1 Purpose of instrument ....................................................................................... 7
1.2.2. The Testing Principle of Coagulation Method .................................................. 7
1.2.3 Instrument Appearance ..................................................................................... 8
1.2.4 Description of Test Procedure: .......................................................................... 9
1.2.5 Description of sample area ............................................................................... 9
1.2.7 Description of the incubation-measurement block ........................................... 11
1.2.8 Description of Cleaning Area .......................................................................... 12
1.2.9 Description of the sample distribution system ............................................ 13
1.2.10 Description of pipes system .......................................................................... 14
1.2.11 Description of circuit system.......................................................................... 18
1.3 TECHNICAL SPECIFICATIONS ............................................................................................ 20
1.4 SYMBOLS AND WARNINGS ................................................................................................. 21
1.4.1 Significations of the SF-400 Signs ................................................................................. 21
1.4.2 General Warnings ...................................................................................... 22
1.4.3 Warnings concerning the handling of biological products .......................... 23
1.4.4 Warnings concerning the Test Setup .......................................................... 23
1.4.5 Warnings concerning the instrument .......................................................... 24
1.4.6 Warnings on the safe disposal of waste materials ..................................... 24
2、ROUTINE USE .................................................................................................................. 24
2.1 Routine Preparing Task .......................................................................................................... 24
2.1.1 Start-up the machine................................................................................... 24
2.1.2 Changing the cuvette roll ............................................................................ 25
2.1.3 Dispose the waste ...................................................................................... 26
2.1.4 Loading the washing solution ..................................................................... 27
2.1.5 Preparation of Specimen ................................................................................. 27
2.1.6 Reagent Preparation ................................................................................... 28
2.1.7 Pipe Maintenance ....................................................................................... 28
2.1.8 Shut down Computer .................................................................................. 28
2.2 Quality Control ........................................................................................................................ 29
2.2.1 Quality Control Screen................................................................................ 29
2.2.2 Quality Control Method .............................................................................. 29
2.2.3 Confirm a QC Result.................................................................................. 29
2.2.4 Query QC Value and Curve ....................................................................... 30
2.2.5 Deleting a quality control result ................................................................. 30
2.3 Calibration............................................................................................................................... 31
2.3.1 Calibration Screen ...................................................................................... 31
2.3.2 FIB Calibration Method .............................................................................. 31

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2.3.3 Validating a calibration ............................................................................... 32

2.3.4 Changing the calibration curve ....................................................................... 33
2.4 Test ......................................................................................................................................... 33
2.4.1 Test Screen ................................................................................................. 33
2.4.2 Set test setup .............................................................................................. 33
2.4.3 Modifying test setup .................................................................................... 34
2.4.4 Deleting test setup ...................................................................................... 35
2.4.5 Adding test setup during test ...................................................................... 35
2.4.6 Machine Observation during test ............................................................... 36
2.5 Information Record............................................................................................................. 36
2.5.1 Patient information screen .......................................................................... 36
2.5.2 Recording method ...................................................................................... 36
2.6 Query result and print......................................................................................................... 36
2.6.1 Query result screen .................................................................................... 36
2.6.2 Query method ............................................................................................. 37
2.6.3 Result verification ............................................................................................ 38
2.6.4 Print ............................................................................................................. 38
2.6.5 Export information ....................................................................................... 38
2.7 Daily operation flow ................................................................................................................ 38
3、MAINTENANCE ................................................................................................................. 40
3.1 Preventive Maintenance Schedule ......................................................................................... 40
3.2 Daily Preventive Maintenance ................................................................................................ 41
3.2.1 Maintain pipes ............................................................................................. 41
3.2.2 Adding washing solution、dispose waste liquid .......................................... 41
3.2.3 Cleaning the needles .................................................................................. 41
3.2.4 Cleaning the racks ...................................................................................... 41
3.2.5 Cleaning the operation panel ...................................................................... 41
3.2.6 Cleaning the used cuvette drawer .............................................................. 42
3.3 Weekly preventive maintenance ............................................................................................ 42
3.3.1 Check the needles are air-logged or not ...................................................... 42
3.4 Monthly preventive maintenance............................................................................................ 42
3.4.1 Cleaning the washing bucket...................................................................... 42
3.4.2 Check the injection pump pipes.................................................................. 42
3.5 Quarterly preventive maintenance ..................................................................................... 43
3.5.1 Check all pipes............................................................................................ 43
3.5.2 Replacing drain pump pipes ....................................................................... 43
4． Description of Software ............................................................................................. 43
4.1 Function Panel ........................................................................................................................ 43
4.2 Important Setup .................................................................................................................. 43
4.2.1 Reagent Management ................................................................................ 44
4.2.2 Test setup.................................................................................................... 45
4.2.3 Test Items.................................................................................................... 46
4.2.4 Test Results ................................................................................................ 47
4.2.5 Parameters Setup ....................................................................................... 47

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4.3 Data Maintenance .................................................................................................................. 50

4.3.1 Data maintenance content .......................................................................... 50
4.3.2 Data maintenance screen ............................................................................... 50
4.3.3 Data maintenance method.......................................................................... 51
4.4 User Management .................................................................................................................. 51
4.4.1 User management screen .......................................................................... 51
4.4.2 Add new user method ..................................................................................... 52
4.4.3 Change user password ............................................................................... 52
4.4.3 Delete User ..................................................................................................... 52
4.5 Test ......................................................................................................................................... 52
4.5.1 Test screen ...................................................................................................... 52
4.5.2 Set test setup .............................................................................................. 52
4.5.3 Modify test setup ......................................................................................... 54
4.5.4 Delete test setup ......................................................................................... 54
4.5.5 Adding a test setup during test ................................................................... 54
4.5.6 Machine Observation during Test ............................................................... 54
4.5.7 Emergency test ........................................................................................... 54
4.6 Information Record ................................................................................................................. 55
4.6.1 Patient information screen .......................................................................... 55
4.6.2 Record Method ........................................................................................... 55
4.7 Quality Control ........................................................................................................................ 55
4.7.1 Quality Control Screen .................................................................................... 55
4．7．2 Quality Control Method .............................................................................. 56
4．7．3 Confirm a QC Result .................................................................................. 56
4.7.4 Query QC Value and Curve ........................................................................ 56
4.7.5 Deleting a quality control result .................................................................. 57
4.8 Calibration............................................................................................................................... 57
4.8.1 Calibration Screen ........................................................................................ 57
4.8.2 FIB Calibration Method ............................................................................... 58
4.8.3 Validating a calibration ................................................................................ 59
4.8.4 Changing the calibration curve ....................................................................... 59
4.9 Query Results ......................................................................................................................... 59
4.9.1 Query Screen................................................................................................ 59
4.9.2 Query method ........................................................................................... 60
4.10 Result verification ................................................................................................................. 60
4.10.1 Single verification .......................................................................................... 60
4.10.2 Batch verification ........................................................................................... 60
4.11 Results printing ..................................................................................................................... 61
4.11.1 Single printing ................................................................................................ 61
4.11.2 Batch printing................................................................................................. 61
4.12 Print report ............................................................................................................................ 61
Appendix：the use of report Creator ...................................................................................... 61

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 SF-8050 Automatic Coagulation Analyzer Manual

Read this manual carefully before using this instrument！

Product: Automatic Coagulation

Specification：SF-8050
Analyzer

Beijing SUCCEEDER Technology Development Co., Ltd

Tower 1A No. 27 Chuangxin Rd. Tech. Park Changping District Beijing China

After-service and maintenance special line（free）

：800 810 8185
Customer complaint special line（free） ：800 810 8185
Fax： +86 -10-89701711
Factory Address: 3F Tower 1 No. 1 Xingchang Rd. E. Tech. Park Nanshao Town Changping District
Beijing China 102200
http://www.succeeder.com.cn
E-mail：[email protected]

INFORMATION ABOUT AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

NAME：Wellkang Ltd t/a Wellkang Tech Consulting

Tel：+44 (20)30869438 ，32876300

Fax：+44(20)76811874

Address：Suite B, 29 Harley Street LONDON W1G 9QR， England, United Kingdom

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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 SF-8050 Automatic Coagulation Analyzer Manual

1. REFERENCES

1.1 INSTALLATION

1.1.1 Installation requirements

SPACE DIMENSIONS
Height:850mm
Width:700mm
Length:1100mm
Minimum Diameter (In operation)
Maximum Diameter (Cover open)
MAIN POWER:
Voltage and tolerance: 100-240V～
Frequency: 50/60HZ
Power: 450W Max

1.1.2 Installation procedure

The professional engineer from Beijing Succeeder Technology Development Co. Ltd can
only install SF-8050 Automatic Coagulation Analyzer:
1. Connect computer、monitor、 keyboard、 mouse、printer and power。
2. Connect the power cable to SF-8050 power socket.
3. Connect the two ends of the serial port cable to RS232 port of SF-8050 and COM1 of
the computer.
4. Connect the two 2×4 inlet branches protruding from cleaning bucket marked with
―cleanser‖ to ―inlet 1‖and ―inlet 2‖ at the rear of SF-8050,connect two drain pipes of 2×4
to ―drain‖ sign at the rear of instrument, the other ends insert to waste solution bucket.
5. Connect the other end of the black cable protruding from cleaning bucket marked with
―washing solution‖ to ―liquid level alarming‖ sign at the rear of instrument.
Cautions: when moving SF-8050:
 Fix the belts of 4 directions of XYZ movable device and the belts of
cuvette-hooking.
 Fix the waste bin.

1.1.3 Connecting peripherals

-- Computer
-- Monitor
-- Keyboard
-- Mouse
-- Printer

DIAGRAM OF EXTERNEL CONNECTIONS:（no）

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Interface description :(no)

1.2 INSTRUMENT INTRODUCTIONS

1.2.1 Purpose of instrument

SF-8050 Automatic Coagulation Analyzer is an automatic instrument for clotting test which
use voltage AC 100-240V. SF-8050 can be used for clinical test and pre-operative screening.
Hospitals and medical scientific researchers also can use SF-8050. Which adopts
coagulation and immunoturbidimetry、chromogenic method to test the clotting of plasma。
The instrument shows that clotting measurement value is the clotting time (in seconds). If
the test item is calibrated by calibration plasma, it can also display other related results.
The product is made of sampling needle movable unit、 cleaning unit、 cuvettes
movable unit、 heating and cooling unit、 test unit、 operation-displayed unit、 RS232
interface (used for printer and transfer date to PC).
Technology and experienced staffs and analyzers of high quality and strict quality
management are the guarantee of manufacture of SF-8050 and good quality. We guarantee
each instrument inspected and tested strictly. SF-8050 meets country standard, industry
standard, enterprise standard and IEC standard.

1.2.2. The Testing Principle of Coagulation Method

The coagulation test of the instrument adopts coagulation method. The method of
judgment is induction method. The principle consists in measuring the variation in amplitude of
the ball oscillation. A drop in amplitude corresponds to an increase in the viscosity of the
medium, i.e. to the coagulation phenomenon. The instrument can figure out the clotting time by
the motion of the ball.

Clotting

Ball Motion Schema

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Immunoturbidimetry are chemical tests used to detect or quantify a specific substance, the analyte, in a blood
or body fluid sample, using an immunological reaction. Immunoassays are highly sensitive and specific.
Their high specificity results from the use of antibodies and purified antigens as reagents. An antibody is a
protein (immunoglobulin) produced by B-lymphocytes (immune cells) in response to stimulation by an
antigen. Immunoassays measure the formation of antibody-antigen complexes and detect them via an
indicator reaction. High sensitivity is achieved by using an indicator system (e.g., enzyme label) that results
in amplification of the measured product.
Chromogenic substrates are peptides that react with proteolytic enzymes under the formation of color.
They are made synthetically and are designed to possess a selectivity similar to that of the natural substrate
for the enzyme. Attached to the peptide part of the chromogenic substrate is a chemical group which when
released after the enzyme cleavage gives rise to color. The color change can be followed
spectrophotometrically and is proportional to the proteolytic activity.
The chromogenic substrate technology was developed in the early 1970s, and has since then become a tool of
substantial importance in basic research. The majority of chromogenic substrate applications are found in
various clinical fields. In particular they have been used to generate fundamental knowledge of the
mechanisms regulating blood coagulation and fibrinolysis.

1.2.3 Instrument Appearance

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1.2.4 Description of Test Procedure:

Diagram of testing Procedure

Sample needle clean

Sample and first reagent 37℃

incubation
Second reagent cuvette time results

Reagent needle clean

The plasma is pipetted by sampling needle then distributed in a cuvette of incubation site. If the first
reagent is needed, the sampling needle will pipette the first reagent to the cuvette of incubation site.
When reaching incubation time, cuvette-hooking system startup, hooking the cuvette of incubation
site to test site. At the same time, reagent needle pipettes reagent to the cuvette of test site, then test
starts. When test finished, cuvette-hooking system will hook the cuvette from test site and throws it
into the waste bin.

1.2.5 Description of sample area

Sample area (which is made of sample stand and sample rack) locates at the left side of the
operation panel,
 Sample rack stand
Sample rack stand is fixed under the operation panel, used to place sample rack.

 Sample rack
SF-8050 sample rack has two gauges of 2.7mL and 5mL with 30 tubes
--Illustration as below:

30

Sample Rack（2.7ml） 1

Sample Rack Stand No.1 placed at the lower left corner

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 Sample Loading
SF-8050 loading samples, only after centrifuging the specimens (collecting blood by
vacuum tube), then inserting them to the rack directly. If using vacuum tube of 5 ml,
please use the rack of 5 ml. If using vacuum tube of 2.7 ml, please use the rack of 2.7
ml.

Caution! SF-8050 doesn’t recommend using blood-collecting tube of other gauges.

 Description
Reagent chamber is as above illustration, reagent pool in the upper, radiator in the
middle, ventilation duct in the lower. Two stirring position and cooling vane are between
the reagent pool and radiator.
- Reagent pool
- Reagent pool which is visible and black located at the upper has 16 reagent
positions with marks. There is a temperature sensor in the side of the reagent pool.

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- Stirring and cooling position

Stirring site located at the lower of reagent pool with a stirring electric motor inside it，
working with the stirrer, to get magnetic force and stirring function.
After the instrument start-up 30 minutes, the cooling vane can reach work temperature
of 16℃.The instrument can work continuously after given power.
- Radiator
The bigger radiator which is invisible and inside instrument is used to dissipate the
heat produced by cooling vane.
- Ventilation duct
Ventilation duct which is invisible and inside instrument has a fan inside it, which is
also used to dissipate heat. Outside dust cannot enter inner of the instrument

1.2.7 Description of the incubation-measurement block

The incubation-measurement block is the substantial part of SF-8050 。 Including

cuvette-hooking、incubation and testing.

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 Cuvette-hooking part
Illustration（no）
- Description

 Incubation
- Illustration（no）
- Description
 Testing
- Illustration
（no）
- Description

1.2.8 Description of Cleaning Area

Cleaning area includes two cleaning positions、one reagent cleaning site and two drain
pumps.
Cleaning Device
- Illustration

- Description
The cleaning area has two rinsing wells used for sampling needle and reagent
needle. The cleaning device is positioned at the operation panel. The pipes
connection refers to 1.2.10. Each needle is rinsed inside and outside in its rinsing
well between each sampling cycle.

 Reagent Cleaning Site

- See illustration below

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- Description
We can see the cleaning area、reagent cleaning site、reagent site and sample site
clearly on the operation panel。
Reagent cleaning site has only one，behind the cleaning area，used to place the special
reagent cleaning solution。
-- Drain pump
SF-8050 has two drain pumps（peristaltic pump） 。The running status is clockwise.
The pipes’ connection refers to 1.2.10.

1.2.9 Description of the sample distribution system

The distribution system includes XYZ-sledge、sampling needle、and injecting pump .

-- XYZ-sledge (illustration as below)

X-axle Y-axle

Z-axle
To fix To fix
sample reagent
needle needle

- Description
XYZ-sledge includes X-axle、Y-axle and Z-axle（As above illustration） ，which is used
to ensure the distribution system to reach the position exactly. The positions include
sample location、reagent location、cleaning location、reagent cleaning location and
incubation location。

-- The needle of distribution

- Illustration

- Description
SF-8050 has two needles for distribution, which are sample needle and reagent
needle. The sampling needle used for the specimen and the first reagent. Reagent
needle used for the second reagent.
- Function
The needle of distribution has the function of heating and liquid level detection。

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 Heating
The temperature of the distribution needle is 37℃。The reagent needle pipettes
reagent from reagent site with 16℃，which can heat reagent from 16℃ to 37℃
promptly in 2 seconds，thereby，reaching the test requirements。

 Liquid level detection

The needle of distribution can detect liquid level during testing，to ensure it work
normally during testing，we recommend using vacuum blood-sampling tube of 5ml or
2.7ml gauge。（the accessories include the tube rack of 5mL and 2.7mL） ；For the rack
of 2.7ml ，the specimen volume cannot be under 250UL；For the rack of 5 ml，the
specimen volume cannot be under 1ml；The minimum volume of reagent cannot be
under 400UL；the minimum of regent cleaning solution cannot be under 1ml。

-- Injection pump
- Illustration
Electromagnetic
valve

T-joint

Micrometre
syringe

Reagent sample

Sliding
valve

- Description
The sample-dispensing part and the reagent-dispensing part are included in this unit to
ensure the precision of distribution. Electromagnetic valve、T-joint tie-in 、micrometre
syringe (maximum 250ul)、and sliding valve fixed on the distribution part with the rear
motor and belt.
(Refer to 1.2.10 to see the pipes connection). The micrometre syringe moves vertically
driven by sliding valve .And the cleaning solution is pipetted from cleaning bucket to the
needle with the help of electromagnetic valve.

1.2.10 Description of pipes system

-- Description of illustration

- Description of pipes’ color

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 SF-8050 Automatic Coagulation Analyzer Manual

specification：PVC Ø1.5×Ø3.0

Specification: silicone rubber pipe

Ø3.2×Ø1.6
specification：silicone rubber pipe
Ø2×Ø4
specification ： peristaltic pump
pipe Ø3×Ø6

- Description of connector
In the Illustration, The tie-in includes T-joint tie-in、right-angle tie-in、upper pipe tie-in and lower
pipe tie-in。T-joint tie-in and right-angle tie-in don’t need to be fixed，just used for connecting pipeline。
Pipelines connected by two upper tie-ins and two lower tie-ins，which are fixed at the right standing
board。

 Inlet pipeline system

- Illustration of inlet pipelines system

- Specification form

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 SF-8050 Automatic Coagulation Analyzer Manual

Length
Number Material Name Specification Quantity Remarks
（cm）
Silicone
1 Ø2×Ø5 90 1
rubber pipe
Silicone
2 Ø2×Ø5 75 1
rubber pipe
pass through inside o
Silicone f electromagnetic valv
3 Ø1.6×Ø3.2 320 2
rubber pipe e and connect
to inside of T-joint
Outside of T-joint and
Silicone
4 Ø1.6×Ø3.2 175 1 connect to outside of
rubber pipe
electromagnetic valve
Pass through outside
of T-joint and connect
Silicone
5 Ø1.6×Ø3.2 190 1 to outside of
rubber pipe
electromagnetic valve

Connect needle at the

6 PVC Ø1.5×Ø3.0 800 2
place of arrow
Locates at right
Upper standing board and
7 —— 2
tie-in above injection pump

Locates at right
Lower standing board and
8 —— 2
tie-in below injection pump

Silicone
9 Ø2×Ø5 170 1
rubber pipe

10 Adapter 1

11 T-junction 1/8 inches 1

 Drain pipelines system

- Illustration of drain pipelines system

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 SF-8050 Automatic Coagulation Analyzer Manual

-- Specification Form

Length
Number Material Name Specification Quantity Remarks
（cm）
Silicone
1 Ø2×Ø5 350 1
rubber pipe
Silicone
2 Ø2×Ø5 150 2
rubber pipe
Silicone
3 Ø2×Ø5 450 1
rubber pipe
Silicone
4 Ø2×Ø5 250 1
rubber pipe
Silicone
5 Ø2×Ø5 450 1
rubber pipe

7 T-joint tie-in 1/8 —— 1

 Inlet pipe and outlet pipe

- Illustration as below

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- Specification Sheet

length
Number material Name Specification quantity remarks
（cm）
Silicone
The end fixed at
1 rubber Inlet Ø2×Ø5 1000 1
cleaning bucket
pipe
The end
Silicone
connected at
2 rubber outlet Ø2×Ø5 1000 1
waste liquid
pipe
bucket

1.2.11 Description of circuit system

 Circuit Diagram as Below

SF-8050 circuit controlled by mainly control unit: main board.

Main board is responsible for: transmission of all communication commands, movements of motors,
detection of cuvettes, movements of pumps.

Test module controlled by test boards which located below test area.

Switch power, which converts 220V to 24V, supplies all circuit boards.

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Sample probe
reset coupler
Reagent probe

Sample probe
Reagent probe
reset coupler
Address－@D Address－@C

motor
motor
Code: 0011 ON Code: 0010

4321 1 1 1 1 1 1 4321
OFF J12
J11 J4 J9 J10 J5
J13 J13

Motor driving board +24V

1 2 3 4
Motor driving board +24V ５４３２１ ５４３２１
J2 J3 J4

1 2 3 4 5
+24V
GND
GND
J18 J17 J18 J17 J2 J1

＋3.3V
J7 GND

GND
GND COM 0- +12V

Heating
COM 0+

3 2 1
COM1+

COM1+

COM1+
COM1-

COM1-
GND

COM1-

film
GND

+24V
+24V

GND

GND

+24V

1
GND
3 2 1
+24V
Opto-
COM1-

COM1-
J1 1 2 3 4 5 J6 1 J7 1 +24V

COM1+
GND
COM1+
GND

1 2 3 4 5

J6
coupler
Liquid

Liquid
sensor

sensor
+24V
+24V

+3.3V GND

3 2 1
J10 J6 GND
Heating board

10 pin
GND COM 0-
J8 （C board）

Temperature sensor of
1 1 1 1 Connect 2&3 COM 0+
J10 3.3V

3 2 1
J10 J8
J8
Address pin of J9

incubation area
Address Reagent probe
control board
Sample probe
control board | microsensor
GND Master board +24V

1 2 3 4 5
| GND
@B @A (AOF） (B board) J5 GND

J9
J9 +24V

J17
J9

1 2 3 4 5
COM 0- USB to 485 board

1
GND

1
COM 0+
GND J14
TEMP control

Functional
(Yellow)

Functional
Heating

jumper

COM 1-
(White)

J19
jumper

COM 1+ J10
Reagent valve reset coupler

Sample valve reset coupler

GND Serial Port

1 2 3
J3 10 pin

1
Reagent valve motor

(Reserved)
Sample valve motor

+24V +3.3V

1 2 3 4 5
GND
Reagent valve

J15
Sample valve

GND Functional jumper

COM 1-
Address－@F Address－@E COM 1+

COM 1+
Code: 0101

COM 1-
Code: 0100

+3.3V
+24V
GND
GND

GND
4321 1 1 1 1 1 1 4321 ５４３２１ ５４３２１
J11 J4 J9 J10 J5 J12 J13 1 2 3 4 5
J11 3 2 1 J1 20 pin
J2 J1
J13 J13
+12V

Cooling

3 2 1
plate
GND

1
Motor driving board Motor driving board +24V
J2 J3 10针
1 1 1 1 1 1 1 1
1 2 3 1 2 3 4 5

J6
J18 J17 J18 J17 J2 J3 J4 J5 J6 J7 J8 J9
J1
Cooling board
COM1+
COM1-

2 big coil (back)

3 big coil (front)
2 big coil (front)
1 big coil (front)

1 big coil (back)

GND

3 big coil (back)

+24V

GND

4 big coil (front)

4 big coil (back)

nd

rd
nd
st

st

rd
Warning,

th
J6 J7

th

Temperature sensor of
J1 1 2 3 4 5 1 1
（D board）
inflow pump board

cooling area
J9
J17
1

1
+12V
GND
J19 J10
J5 J4
Y motor

X motor

J7 J6 J3 J2
coupler
Y reset

10 pin
coupler
X reset

1
Address－@H Address－@G
Test board
1 1 1 1 1
Code:0111 Code: 0110
Functional jumper
（A board）

Cooling fan
1 1 1 1 1 1
Lack liquid warning

Inflow pump
Reserved

Reserved

Stir motor 2
Stir motor 1
Outflow pump

4321 4321
Full liquid warning

J11 J4 J9 J10 J5 J12

J13 J13

Motor driving board Motor driving board

J2 J3

Output 24V 14.6A

J18 J17 J18 J17

+v
COM1+
COM1-
GND
+24V

GND

J6 J7
J1 1 2 3 4 5 1 1

-v

Power moudle
P7
Hook Open&Close motor
Hook U&D reset coupler

Hook O&C reset coupler

Hook Up&Down motor

N
L
Hook motor

Hook reset
coupler

Address－@J Address－@I Address－@K Address－@L

Roller
motor

D
N
G
Code:1001 Code: 1000 Code: 1010 Code:1011
4321 1 1 1 1 1 1 4321 1 1 1 1 1 1
4321 4321
J11 J4 J9 J10 J5 J12 J12
J11 J4 J9 J10 J5
J13 J13 J13 J13

Motor driving board Motor driving board Motor driving board Motor driving board
J2 J3 J2 J3
J18 J17 J18 J17 J18 J17 J18 J17
COM1+
COM1-

COM1+
COM1-
GND
+24V

GND

GND
+24V

GND

J1 1 2 3 4 5
J6 J7 J6 J7
Miniwatt Drive,
Power Power
1 1 J1 1 2 3 4 5 1 1
cannot replace with button socket
other motor board

Description 
The circuit of SF-8050 consists of 19 circuit boards、one power switch and one
switch button.。According to function, the circuit can be divided into control、test、
electric-motor drive、power、temperature and liquid level induction，six sections in total。
- Control
The control section of SF-8050 circuit consists of two circuit boards，which are A control
board and B control board。
 A-control board mainly takes charge of：
--The light-coupled control of Sampling needle、reagent needle、X-axis、Y-axis、
sampling-needle electromagnetic valve and reagent needle electromagnetic valve。
--Motor control of sample needle、reagent needle、X-axle、Y-axle、2 drain pumps、sample
needle injection pump and reagent needle injection pump；
--Switch scope of sample needle and reagent needle valve, switch scope control of
stirring motor；
--Liquid level induction control of sample needle and reagent needle。

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 B-control board mainly takes charge of：

--Light-coupled control of the origin of cuvette-hooking、the first incubation position；
--Control of the motor of cuvette-hooking；
--temperature control of sample needle、reagent needle、reagent position、incubation
position；
--Temperature sensor control of sample needle、reagent needle、reagent position、
incubation position。
- Test
The test circuit section of SF-8050 consists of two circuit boards. No.1 test board
and no.2 test board。 No.1 test board locates at the back of the machine，and no.2 test
board locates at the bottom of the incubation position。
 No.1 test board mainly takes charge of data collection and transmitting。
 No.2 test board mainly takes charge of the function of test.
- Power supply
The power section of SF-8050 circuit consists of switch power and power board。
 Switch power varies voltage from 220V to 24V, which supplies to power board
and cooling board。
 Power board supplies to test board。
- Temperature
The temperature part of SF-8050 is heating and cooling board. Which controls the
temperature of heating membrane and cooling vane。
- Liquid level induction
The liquid level induction of SF-8050 circuit includes the two liquid level board of
sample needle and the liquid level alarm board of cleaning solution.
 The liquid level board of sample needle controls the liquid level induction of
sample needle and reagent needle respectively。
 The liquid level alarm board connects to the induction floater which is in the
cleaning bucket. When the liquid level is under the floater，the machine will alarm to
remind user。

1.3 TECHNICAL SPECIFICATIONS

Power supply voltage （100-240）V ～

frequency 50Hz/60Hz
Input power 450VA
Work environment temperature 15℃～28℃
Humidity ≤70％
Atmospheric pressure 86.0kPa～106.0kPa
no strong magnetic field interference、no intensive shake、no caustic gas
near test system which should avoid direct sunshine and away from heat。
Test principle test method： Coagulation and optical method
Judgment method：induction method

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Test sample Platelet-poor plasma using sodium citrate as anticoagulant

Test Item PT、APTT、TT、FIB、HEP、LMWH、PC、PS、Factor II、Factor V、
Factor VII、Factor VIII、Factor IX、Factor X、Factor XI、Factor XII、AT
Show of Test results s、%、INR、g/L、mg/dl、IU/ml、R
Information output and input Input information by keyboard
Information displayed on screen
Printer
PC (optional)
Sample sites 30
Reagent sites 16
Testing sites 6
Incubation sites 10
Cleaning sites 2
Range of sample volume 10μl～250μl
Error ≤5％ or ±2μl，take max.
Temperature: Sample incubation area: 37℃±2℃
Reagent area 16℃±2℃
Sampling needle 37℃±2℃
CV CV≤5％
Precision meets the prescriptive test scope.
Cross-Contamination contamination rate less than 2％
Linear measure |r|≥0.980
Figuration dimension（L×W×H，mm） 560×700×540
Weight 45kg
Consumables cuvettes with built-in stainless steel balls

1.4 SYMBOLS AND WARNINGS

1.4.1 Significations of the SF-8050 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.

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1.4.2 General Warnings

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.
 Warning :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.
 Note: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.
 Note :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.

 Caution : 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.
 Warning :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.
Warning :Please carefully read the potential contamination warning regarding all
biological products (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).
 Note: 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；

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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（100-240）V, you may
use UPS type voltage regulators instead of those of common types.
g） This IVD equipment complies with the emission and immunity requirements described in BS
EN61326-1:2006 and BS EN 61326-2-6：2006 .
 Warning : This equipment has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take measures to
mitigate the interference.
 Warning : An electromagnetic environment should be evaluated prior to operation of the device.
 Warning :Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g.
unshielded intentional RF sources), as these may interfere with the proper operation.
 Please shut off the power, put off the power plug and leave it to a professional under the following
circumstances:
 It is the manufacturer’s responsibility to provide equipment electromagnetic compatibility
information to the customer or user.
 It is the user’s responsibility to ensure that a compatible electromagnetic environment for the
equipment can be maintained in order that the device will perform as intended.
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.

1.4.3 Warnings concerning the handling of biological products

For all products (reagents, calibration, control plasmas and patient plasmas), please
observe the necessary precautions regarding potentially contaminated biological products, in
accordance with current legislation:
 Do not eat, drink or smoke in areas where these products are being handled.
 Use disposable gloves and handle all these products as a potential source of infection.
 Use running water to rinse and Consult your physician immediately in case of ingestion
or contact with mucosa or skin lesions.
 Dispose of all products as if they were infected, in accordance with current legislation
and regulations (e.g.: heat sterilization, incineration of disposables, and use of sodium
hypochlorite for liquid waste).

1.4.4 Warnings concerning the Test Setup

The test setups supplied by SUCCEEDER have been individually validated for the SF-8050
machine and the possible interactions between the reagents should be taken into account
when performing the assays..

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1.4.5 Warnings concerning the instrument

SF-8050 may only be installed by personnel duly authorized by SUCCEEDER Company, or

by its authorized representatives.
In order to avoid the risk of electric shock, it is imperative that the procedures described in
this document be scrupulously observed.
For the safety reasons, hold the cover of the SF-8050 while closing it.
For the safety reasons, it is forbidden to place irrelated articles on the operation panel
during test. If the machine 24 hours on open, under the condition of 4 hours the machine not
running, please first make maintenance for the pipes then make test.

1.4.6 Warnings on the safe disposal of waste materials

The waste materials of consumables, used reagents or reagent products including those
mixed with specimens should be disposed as medical waste. The discarded instruments or
components thereof should be disposed according to the local regulations.

2、ROUTINE USE

2.1 Routine Preparing Task

2.1.1 Start-up the machine

SF-8050 is designed to run 24 hours continuously。

 Open the cover of SF-8050
 Turn on the power switch on the front panel of the machine.
 Turn on the screen switch.
 Turn on the computer power switch..
 Turn on the printer power switch.
 Double click the short-cut icon of the SF-8050 program.
 The user’s login screen as below

 Enter the user’s name and the password, then click ―OK‖
- The software start-up，the machine performs initialization (sampling system reset，

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cuvette-hooking system reset).

 After 30 minutes，the temperature of instrument is in stabilization status。
 SF-8050 is ready for use.

2.1.2 Changing the cuvette roll

Every new cuvette roll always includes a reel which is held onto the roll by a film on which the
cuvettes are fixed。
Central hole

Wheel

 Open the left door（which is hung by a bolt, first uplift then pull outside。
 Remove the empty cuvette roll

①
②
⑤

⑥
⑤

④ ⑧

⑦
① Cuvette roll
② a cap to prevent the roll from sliding out
③ Top pulley

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④ Lower pulley
⑤ a handle to turn the film
⑥ a small block to press the film
⑦ a small block to stop the film
⑧ First incubation place
- Turn the number ⑤ two circles by the direction of clockwise and loosen the film.
- Unbolt the small block of number ⑤，take out the film.
- Position the film by the order of number ⑥、④、③.
- Take out the cap of number ②，and remove the reel.
 Install a new cuvette roll
- Take out the cap of number ②，slide the roll along its spindle and lower the catch
holding the roll in its place.

Caution！Please pay attention to the direction of installation. The turning direction of film is
clockwise。Commonly, the label towards outside.

- Fix the cap of number ②.

- Position the film by the order of number ③、④、⑥.
- Turn number ⑤ counterclockwise，do not over fasten.
- The cuvette roll installed.
 Adjust
- Raise the small block of number ⑦，back the first incubation site，until connect to
new cuvettes.

- Click the icon in software toolbar（change cuvette roll）

，the machine will start
up cuvette transportation system automatically，then stop after searching the first
incubation site。
 upper left door

2.1.3 Dispose the waste

Caution！The waste bin contains potentially infectious biological materials and must be
handled in accordance with current local regulations: wear disposable gloves.

 For the sake of cleaning，it is recommended that the waste bin be covered a plastic
bag.
 Open the right door.
 Take out the used cuvette drawer, discard the waste。
 Dispose of the plastic bag in accordance with current local regulations。Incineration is
recommended in most countries。
 Cover a new plastic bag in the drawer。
 Put back the drawer into the SF-8050 ensuring that it is down fully in its holding place。
 Close the right door of the instrument.

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2.1.4 Loading the washing solution

Caution！The bucket of waste solution contains potentially infectious biological materials and must be
handled in accordance with current local regulations: wear disposable gloves.

The accessories come with the machine，including washing bucket and waste solution
bucket。Distilled water used for washing bucket In which contains liquid level induction device。When
giving liquid level alarm，the user must fill up distilled water in washing bucket（other liquid can not be
used）and dispose of the waste bucket immediately。

2.1.5 Preparation of Specimen

The guideline of specimen collection used for coagulation testing refers to NCCLS
document H21-A3 “Collection, Transport, and processing of Blood Specimens for Coagulation
Testing and General Performance of Coagulation Assays; Approved Guideline—Third
Edition”。This document provides procedures for collecting、transporting、and storing blood；
processing blood specimens ； storage of plasma for coagulation testing ； general
recommendations for performing the test。
 Anticoagulant
- The anticoagulant used for coagulation assays should be 105－109mmol/L，3.13％－3.2％
（commonly described as 3.2%）of the dehydrate form of sodium citrate（Na3C6H5O7·2H2O）。Other
anticoagulants (e.g. heparin 、 EDTA 、 oxalate) are unacceptable. The final concentration of
anticoagulant in the blood is 10.9－12.9mmol/L。
- The proportion of blood to the anticoagulant volume is 9:1.
- The anticoagulant in the blood should be adjusted in patients who have PCV values above 55% or
below 20%.The anticoagulant volume may be adjusted from the expression:
x = volume of anticoagulant blood×[ （100 - PCV）/（ 595 - PCV） ]

Where,
x is the volume of anticoagulant in ml，
PCV is the packed cell volume in ％，
e.g.：to determine the volume required for 5ml anticoagulant blood，the patient’s
PCV is 20%， the anticoagulant x＝0.7ml

 The device used for touching blood must be plastic products. E.g. tube、 pipette、
syringe。
 The drawing sample can not be less than 2Ml
 Specimen Collection
- Time: drawing blood should be limosis in the morning.
- Body part: commonly draw venous blood in the front elbow。
- Drawing blood should be aculeate. Avoid puncturing time after time，and avoid
hemolysis. Platelets may congregate because of stimulating（if hemolysis occur, the
blood should be drawn again）.Meanwhile, we also should avoid drawing tissue fluid
into syringe or cause air leak。 Mixing blood and anticoagulant should be gentle
inversion and can not be agitation。

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 Specimen Preparation
Centrifuge the mixed anticoagulant blood at temperature of 25℃-32℃ and spin
at 2000 to 2500 r.p.m for 10 minutes. Take it out after centrifugal machine stopped
（if hemolysis occurs, drawing blood again ） ，the top clear liquid in the tube is
platelet-poor plasma（PPP） 。
 Storage of Specimen
- For coagulation testing, specimens for PT assays kept at 18 to 24℃ should be
tested within 24 hours from time of specimen collection；Specimens for APTT
assays kept at 18 to 24℃ should be tested within 4 hours；Specimens for other
assays（e.g. FIB、PC、Factor V、Factor VIII）should be tested within 4 hours from
time of specimen collection。
- If the coagulation testing cannot be performed immediately，the sample may be held
for two hours at 4℃ until tested. If the testing is not completed within 24 hours for
PT specimens and 4 hours for APTT and for other assays specimens, plasma
should be frozen at -20℃ for up to 2 weeks or -70℃ for up to 6 months。Frozen
plasma samples should be rapidly thawed at 37℃ and tested immediately。The
APTT may be affected on specimens which have been frozen.

2.1.6 Reagent Preparation

Please reference the manual of the reagent.

2.1.7 Pipe Maintenance

 Operation

- Click the icon in software toolbar，to make pipe maintenance。

 Purpose

- Making pipe maintenance, the purpose is to make the pipes of sample-adding

system full of washing solution, and reduces air bubbles on tube-wall. Also to avoid
inaccurate sample volume and the testing results may be affected。
 Requirements
- Make pipeline maintenance before starting test in every morning。
- During the use of a day，the SF-8050 is not used in 3 hours interval between testing,
please make pipeline maintenance again before use.

2.1.8 Shut down Computer

 Click the― ‖icon at upper right corner on screen, exit program.

 Shut down the printer.
 Shut down the computer.
 Shut down the screen.
 Turn off the front power switch of SF-8050.

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2.2 Quality Control

2.2.1 Quality Control Screen

Click the icon in software toolbar or ― quality control ‖ in menu, displays QC screen。

Test item

QC curve

QC results

2.2.2 Quality Control Method

 Dissolve quality control plasma.

 Check the reagent volume of each item.
 Pour the dissolved QC plasma into a tube，normal QC put into NO.1 position in tube
rack, patient QC put into No.2 position in tube rack.。
（If not to do patient QC，No.1
position of tube rack should be placed normal QC only，and No.2 position of tube rack
is empty）.
Caution！Here please use the tube rack of 2.7ml 。
 Choose the QC item which is ready， in ―QC item‖ box，click the small box before the
item，after the item is chosen，the box shows a tick―√‖。
 Choose the QC type，as above screen in QC type box。QC type includes N-test and
P-test。

 Click , starts quality control。

 Click ，QC is interrupted，now ―pause‖ button turn to ―resume‖ button，

click the button again, quality control will be going on。

 Cancel the QC by Clicking 。

2.2.3 Confirm a QC Result

When QC finished，the results will be shown in ―QC results‖ as above screen。Confirm by

clicking ―Save‖，and confirm the save is successful。

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2.2.4 Query QC Value and Curve

 In test item box as above screen，choose an item，e.g. PT, and choose QC type as below.

 To see normal QC results，choose ；to see patient QC results，choose .

 After selected, displays the ―Stat. Conditions‖ dialog box as below，write down the date which is
querying.

 Click ―OK‖，the QC curve which is accordant with the time will be displayed in ―QC curve sheet‖。
In addition ， the daily QC result will be displayed in ―QC result‖ section ， including the
corresponding ―Average‖ and ―SD‖ result.

 Click ，displays and ，

Caution！A thirty-one-day’s QC value and curve are displayed once at most。

2.2.5 Deleting a quality control result

 In ―Last Result‖ box，click the QC value which has to be deleted。

 Click ―Delete‖，the value is deleted。

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2.3 Calibration

2.3.1 Calibration Screen

Click the icon in toolbar or ―Calibration‖ in menu，displays calibration screen。

Calibration curve
Test item

Calibration.
Result
Calibration.

Information.

2.3.2 FIB Calibration Method

-- In test item box, choose FIB, as below

-- Dissolve calibration plasma, ready for use, put 4 tubes into tube rack from No.1 to No.4, and
dilute calibration plasma manually as following:

FIB Dilution
Dilute. Ratio Plasma + Buffer

2c 50ul+200ul

c 50ul+450ul

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c/2 50ul+950ul

c/3 50ul+1450ul

C is FIB plasma content

-- Check the corresponding reagent volume.

-- Click and start button, starts reagent calibration.

-- Click Pause, the calibration is interrupted, now ―Pause‖ button turns to ― Resume‖, click it again,
the calibration will be going on.
-- Click Stop, the current calibration will be cancelled.
PT Calibration Method
-- In test item box, choose PT as above.
-- Dissolve calibration plasma, ready for use, put 4 tubes into tube rack from No.1 to No.4, and
dilute calibration plasma manually as following:

PT Dilution

Dilute. Ratio Plasma + Saline

100% 400ul

75% 300ul+100ul

50% 200+200ul

25% 100+300ul

-- Check the corresponding reagent volume.

-- Click button, start reagent calibration.

-- Click Pause, the calibration is interrupted, now ―Pause‖ button turns to ―Resume‖, click it again,
the calibration will be going on.
-- Click Stop, the current calibration will be cancelled.
Caution! When doing calibration, please use the tube rack of 2.7 ml.

2.3.3 Validating a calibration

 The calibration finished，the time results of corresponding concentration are displayed in the box
of ―Results‖。
 To see the correlation of the current calibration（which is displayed in correlation box） ，If past
0.98，the curve is advisable。
 Click ―Save‖。
 Validate the calibration curve。

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2.3.4 Changing the calibration curve

 According to the above―2.3.2 calibration method‖，redo calibration。

 Input the time of corresponding concentration in the box of ― Results‖ manually。
 According to―2.3.3 validating a calibration‖，validate the calibration curve。

2.4 Test

2.4.1 Test Screen

Click the icon in toolbar，displays the test screen

Test results

info.

2.4.2 Set test setup

 Setup a few tests

- Put the sample into the tube position on the rack.
- Check the reagent volume

- In test results area as above screen ,in the column of double click the
box which is corresponding to left tube number ，enter the Test ID of sample. The
test ID can not be the same in one day.
- Double click the item to be tested, when the icon appears in the column of item
（waiting to be tested）,which shows the item is selected.

- Click ，then begin test.

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- Click ，the testing will be cancelled.

 Batch Test Setup
- Put the sample into the tube position on the rack.
- Check the reagent volume.
- Click ―Batch‖ on test screen, displays ―Batch test‖ dialog box。

- In batch test dialog box, the user can make setup for sample position、Test ID、Test
List、and test mode。
① In sample Position box, the start number and end number correspond to the
sample number respectively；
② In test ID box, the user can set a number for the first sample（the other
samples will be given number automatically by system） ；
③ In ―test list‖ box, Click the selected item，before which the small box shows a
tick ―√‖，which shows the item is selected；
④ In test Mode box, ―by sample‖ means sample will be priority during test，after
finishing the selected items of current sample, then begin the next selected
items of sample。―By test‖ means after finishing the current item of all samples,
then begin another item of all samples。

- Click , batch setup finished.

- Check the setup information，the test ID can not be same in one day.

- Click ，begin test.

- Click ，the test will be cancelled.

2.4.3 Modifying test setup

 Modify test ID
- Double click the test ID which needs to be modified ， the box is like the

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following , in which user can input information。

- Input the correct test ID by keyboard.

--Modify test item which is ready：double click the selected item，the current item will be
cancelled。

2.4.4 Deleting test setup

 Delete whole test setup

- Click ，the whole test screen is cleared， the test task is also cancelled.
 ―Batch Cancel‖ setup
- Right click ―mouse‖ on test screen, choose the cancel task, displays ―Batch Test‖
dialog box。

 Setup the sample position、test ID、test list、and test mode which are going to be
deleted。

 Click the icon，the ―batch cancel‖ finished.

 Double click the selected test item，which can be cancelled.

2.4.5 Adding test setup during test

- Please refer to 2.4.2.

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2.4.6 Machine Observation during test

During the tests, situation of test shows on screen, such as pre-heating, and the time of
pre-heating counts automatically by system. Operator can inspects situation of machine by
screen of computer.

2.5 Information Record

2.5.1 Patient information screen

Click the icon in toolbar, screen shows as below，user can see the patient
information screen，displays the patient information screen。

2.5.2 Recording method

We recommend a simple way, recording the patient information by pressing enter

button。On patient information screen，the cursor defaults in ―Sample ID‖ box（the test ID
given from No.1 everyday），press ENTER button，the cursor goes into the next box，input
information by keyboard，press ENTER button again，and continue the work like above
process。When the cursor reaches ―Save‖，press ENTER button, the current information will
be saved in computer。Then the cursor back to― Test ID‖ and test ID plus 1 automatically。

2.6 Query result and print

2.6.1 Query result screen

Click the icon in toolbar，displays the query screen.

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2.6.2 Query method

 The user can query information by ―General‖、―Date range‖、―Receive‖、and ―Verify

status‖ in query condition box 。

 Click 。The information will be displayed on the right。

Test ID

information

Test result

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 Click any row in test ID information section，the detailed test results will be displayed in
test result section。
 In ―test result‖ section，the user can delete any result which doesn’t accord with
requirement. The deleted result will not be displayed in printed report。

2.6.3 Result verification

-- Single verification
 On the query screen.
 In ―test ID information‖ section, select a test ID which is to be verified。

 Click 。.

-- Batch verification
 On the query screen.
 In ―test ID information‖ section, select the test ID which are to be verified，click the first
information which is to be verified，press ―Shift‖ button，click the last information which
is to be verified, then the all information which is to be verified is selected。

Click 。

2.6.4 Print

 Single print
In ― test ID information‖ area, choose the information which is going to be printed。
Print by Clicking .
 Batch test print
-- On the query screen.
-- In ―test ID information‖ section, select the test ID which are to be printed，click the first
information which is to be printed，press ―Shift‖ button，click the last information which
is to be printed, then the all information which is to be printed is selected。

-- Click the icon。

2.6.5 Export information

When query finished，click the icon，the query results can be saved at a directory

in the computer hard disk by the format of .txt。Every saved path defaults as the last saved
directory。

2.7 Daily operation flow

 Daily operation flow

- Start machine：open cover→ turn on the power switch in the front panel of

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SF-8050→turn on the switch of screen→ startup the computer→ power on printer→

double click the short-cut icon on desktop，in program→ login in user login
window,→ click ―OK‖ →the machine warm up about 30 minutes。
Maintenance：be full of solution in cleaning bucket→ put the reagent cleaning bottle in the location of
reagent cleaning→ put the reagent bottles in its corresponding location→ click

the― ‖icon to make pipe filling and make maintenance for pipe。
- Quality control：click the― ‖icon，displays the QC screen→ choose QC item（can
operate the four items simultaneously）→pour the QC plasma into tube and put it in
tube rack→ click ―start ‖→QC finished，click ―save‖。

test：click the ― ‖icon，displays test screen→ put the centrifuged specimens

into tube rack by order→ click the beginning tube icon by the mouse right button
→click ―batch test/cancel‖，displays batch screen→ input the beginning and end
number corresponding to specimens，input the beginning number→ choose the test
item→ click ―add‖→ click ―start‖。
- information record：in ―patient information‖ area on the right of screen, choose the
intraday number of specimen→ input the patient’s information→ click ―save‖。
Query and print：click the― ‖icon，displays query screen→ choose the condition in
query condition box→ click ―query‖ →the information will be displayed on the
right→ click the beginning number，press the ―SHIFT‖ button→ click the end number，

select all specimens→ click― ‖，the report will be printed。

- Maintenance before shut down：click the― ‖icon to make pipe filling→ take
out the extra reagent bottles and cleaning bottles, keep them in refrigerator →take
out all specimens from rack→ open the right door, dispose the waste→ close the
right door。
- Shut down：click the― ‖icon on the upper right corner to exit program →shut
down printer →shut down computer →turn off screen →turn off the power switch of
SF8050→close the cover。

 Warnings concerning the use

- The voltage must be within 220V±22V and has the protective earth. The operation
panel must be stable。
- Start and shut down the machine according to the operation flow strictly。

- After the machine startup，click the― ‖icon to make pipe filling before test，
avoid inaccurate pipetted volume。
- Anticoagulant is sodium citrate of 109mmol／L，the proportion of anticoagulant to

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blood is 1：9. It is prohibited to use heparin as anticoagulant, other wise , which may
delay test result；It’s the best to collect blood by vacuum tube，which can avoid
inaccurate results。
- The minimum draw volume is not less than 2ml.After the blood collected，inverting it
immediately for at least 5 times gently and avoid clotting。
- Centrifuging plasma strictly according to the standard of 3000 r.p.m for up to 10 or
15 minutes。
- The reagent bottle must accord with the mark on the reagent location. The minimum
volume of reagent is not under 400 ul，and the minimum volume of cleaning solution
is not under 1000ul。
- When using the rack of 2.7ml，the plasma volume used for centrifuging is not under
250 ul；For the rack of 5ml，the plasma volume is not under 1ml。
- Before shut down machine，make cleaning for the machine.

3、MAINTENANCE

3.1 Preventive Maintenance Schedule

Frequency Type of Maintenance Remarks

Maintain pipes We recommend the user

Add washing solution 、 dispose make maintenance. If any
waste liquid questions, please contact
Daily Clean the needles the service department of
Clean the racks SUEECSS or local agent.
Clean the operation panel
Clean waste bin
Check the needle is air-logged or
Weekly
not
Clean the washing bucket
Monthly
Check the injection pump pipe
Check all pipes
Quarterly Maintenance by engineer
Change drain pump pipes

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3.2 Daily Preventive Maintenance

3.2.1 Maintain pipes

Purpose：eliminate the bubbles in pipes。Avoid inaccurate sample volume。

 Maintain pipes before startup machine。

 Click the― ‖icon, perform the pipe filling，and maintain the pipes.

3.2.2 Adding washing solution、dispose waste liquid

Purpose：avoid inadequate washing solution and inaccurate sample volume。

 Open the cover of washing bucket，it’s not necessary to pull out the inlet pipe from the
washing bucket。
 Add distilled water in the washing bucket。
 Empty the waste liquid 。

3.2.3 Cleaning the needles

Daily preventive maintenance

Purpose：avoid cross contamination。

 Wipe the two needles by tampon moistened with reagent washing solution.

 Click the― ‖icon, perform the pipe filling.

 When finished，use clean tampon to wipe the needle till no presence of liquid。

3.2.4 Cleaning the racks

Daily cleaning the racks，It is recommended to use soft cloth moistened with clean water。
If the specimens splashed in the rack，the rack must be sterilized with 75% medical alcohol。

3.2.5 Cleaning the operation panel

Daily cleaning the operation panel，it is recommended to use soft cloth moistened with clean
water to clean everything on the panel。If the specimens or reagents splashed on the panel，the
operation panel must be sterilized with 75% medical alcohol。

Caution！When cleaning the incubation section，do not touch the springs of test section。In
addition，when cleaning the slot，please use tampon moistened with clean water！

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3.2.6 Cleaning the used cuvette drawer

 Open the right door。

 Take out the used cuvettes drawer, discard the waste。
 Dispose of the plastic bag in accordance with current local regulations。Incineration is
recommended in most countries。
 Cover a new plastic bag in the drawer.
 Put back the drawer into the SF-8050 ensuring that it is down fully in its holding place。
 Close the right door of the instrument.

3.3 Weekly preventive maintenance

3.3.1 Check the needles are air-logged or not

3.4 Monthly preventive maintenance

3.4.1 Cleaning the washing bucket

Monthly preventive maintenance

Aim：clean the inside wall of the bucket and to avoid the accumulation of scale。
 Take out the cover，empty the washing bucket。
 Clean the inside using a brush。
 Flush the bucket using distilled water till fully clean。
 Fill up distilled water。
 Cover it ready for use。

3.4.2 Check the injection pump pipes

Monthly preventive maintenance

Aim：check the pipes to avoid air leaks。

 Click the― ‖icon, perform the pipe filling.

 Open the right door。
 Observe the presence of bubbles in the injection pump
 Pull out the injection pump pipe，to see the pipes cracked or not。

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3.5 Quarterly preventive maintenance

3.5.1 Check all pipes

Refer to the description of 1.2.11 and to check the aging of the pipes and to avoid air leaks。

3.5.2 Replacing drain pump pipes

4． Description of Software

4.1 Function Panel

The function panel is permanently displayed at the top of the screen。Clicking one icon once
displays the corresponding menu:

Displays the Test screen Displays Query screen

Displays the Calibration Displays the Quality

screen Control screen

Displays the Parameter Displays the Users

setup screen management screen

In addition, in the toolbar icon，contains three commands performing mechanical action。

Clicking one icon once performs the corresponding action。

To make pipe filling and

Clear used cuvettes at
pipe maintenance
the incubation location

Replace cuvette roll and

search first incubation
position

4.2 Important Setup

First of all, some important parameters should be made setup when using the software.

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4.2.1 Reagent Management

 Screen
Click the ―Reagent ‖in the menu of ―Maintenance‖ on the main screen，displays the reagent
management screen：

 Operation
In Reagent box，the aim is to enter the used reagent during test and save them。In the
software，contains 6 information of default reagent Lot。User can add new reagent
information and make setup according to their needs。
- Position：No.1 is CaCl2、No.2 is PT 、No.3 is APTT、No.4 is imidazole、No.5 is FIB、
No.6 is TT。
- Volume：CaCl2 is 50ul、PT is 100ul、APTT is 50ul、imidazole is 90ul、FIB is 50ul、
TT is 100ul（the volume refer to reagent description of manufacturer） 。
- During adding PT thrombin，pay attention to normal average and ISI。Different
factory, PT reagent is different。Refer to reagent description。
- The contents to be entered including：reagent lot、manufactory、manufacture date、
shelf-life、position and volume。
- When reagent info. finished，click ―save‖。
- If change the saved reagent information.，click Lot.（right side，marked Lot.），the
information will be displayed in the left ―Lot ‖ box。Then click ―save‖。

Caution！The important basis to distinguish reagent is the lot. The operator can input the
same type reagent manufactured by two or more factories。Ready for next test
setup。

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4.2.2 Test setup

 Screen
Click the ―Test item‖ in the menu of ―Setup‖ on the main toolbar，displays setting screen
as below：

 Operation
After the ―reagent management ‖setup finished, to make ―tests setup‖。The information
with * must be filled in。

- Setup code：the default code as following：FIB1、PT1、TT1、APTT1。

- Sample volume：(Please refer to the reagent description of manufacturer)。
- Diluent ( above screen is Reagent 1)：the diluent is the reagent which is in
incubation processing with sample during the test。The corresponding first reagent
of APTT and FIB respectively is APTT reagent and buffered reagent。There is
pull-down menu used for selecting, the selective content is the reagent lot which
was saved in last procedure。
- During the testing ,the test reagent(above screen is Reagent 2) is used for the
sample which finished incubation。There is pull-down menu used for selecting, the
selective content is the reagent lot which was saved in last procedure。
- Incubation Time：refer to the reagent description。

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- The longest test time：the default time is 180 seconds, APTT is 240 seconds.

In the software made by manufacturer，contains 7 default setup codes。The users can

add new setup code，also can use the default setup code directly。
- If using default code ， click any item in the ―Code‖ box on the right ， the
corresponding information will be displayed on the left 。The user can change
sample volume、diluent、test reagent、incubation time and the maximum time
according to their requirement，then click ―Save‖。
- If adding new code，first click ―New‖，then input the code 、sample volume、diluent、
test reagent、incubation time、and the maximum time respectively。Click ―Save‖，
the new added code will be displayed in the code box on the right。

4.2.3 Test Items

 Operation

- Click any item in the box of ―Code‖。

- The correlative information will be displayed in the left. User can change the full
name and setting of current item. (if change the setting, confirm by clicking Apply).
- Click ―Save‖。
Hint：if do not setup calibration in current item，in calibration screen，the item will not be
displayed。

In the lower right corner， （move up） （move down），they are used to adjust
the order of test items on test screen.
- Click any item in the ―Code‖ box。

- Click― ‖or― ‖。

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- The test item order will be same as the test box on test screen。
- After changing the test order，the test screen needs refresh and exit current setup
then enter test screen。click mouse right button，choosing ―Refresh‖。

4.2.4 Test Results

 Operation
The result screen mainly is to choose unit for all test items，the same item can be
different unit。E.g. for PT item, can use S、INR、R、% as the unit。The user can set the
unit according to their needs and also can set the reference range and results description。
- Click the pull-down menu of ―Tests‖ and select the item which needs setup。
- In ―Result Units‖ box，the user can set ―Code‖、―Limits‖ and ―Description‖（The limits
and description will be displayed in the result report）。
- Click ―Save‖。
In the right on the screen，the user can see the units clearly。If one item has different
units, the units will be displayed by number。E.g. above screen, for PT test：S 1；INR
0。

4.2.5 Parameters Setup

 Screen
On the main screen, click Maintenance then click the Parameters or click the

icon in toolbar，the parameters screen as below：

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 Operation
The parameter setup includes port setup、hospital information and test parameters。
- Port setup
Including Control COM Options and Upload COM Options as above screen。The
control COM is the correlative setup between SF-8050 and PC port，the data port
is the setup for uploading data。
For Control COM Options, mainly to see the setup of COM1 is correct or not，
Only when the COM1 is same as PC port, the communication can be made。Other
items can be default。
For data port setup according PC port of receiving uploading data。
Hint：with the help of professional engineer to do the setup。
- Hospital information

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Fill in hospital name and choose report template。The hospital name will be shown on the title of
report。The test report has three templates from which the user can choose .The template includes
standard 、simple、and compact。In addition，user can use report creator to design their desired
format。 （refer to appendix ）When finished setup，click ―Apply。‖

- Test Parameters
Test parameter includes the times of rinsing needle setup and automatic pipe
filling setup after the machine startup。The user can setup the times of rinsing
needle. The times of rinsing needle is used for test process. if change the times of
rinsing needle, the test speed or test result may be affected。

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Hint：If change the setup, click ―Apply‖，then click OK。

4.3 Data Maintenance

4.3.1 Data maintenance content

The data maintenance content includes the department、the doctor、the payment type and
Sample type。The aim is when entering patient’s information，you can make a selection for
department、doctor、payment type and sample type。Only entering the data，you can make a
selection in the information screen。

Hint：in information record screen, the user can not write for Dept、doctor、fee type and sample
type，he can make selection only。

4.3.2 Data maintenance screen

On the main toolbar, Click ―Dept‖ icon, in which click ―Dept‖, the Dept screen as below：

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Switch Doctor、Fee Type and Sample，enter the corresponding screen respectively。In

manufactory software，some contents can be deleted according to the user’s needs. New
contents filled in, which is added after saving。

4.3.3 Data maintenance method

 Fill in name
 Fill in mnemonic symbol, which is to help remember name easily. The user can set it
according to their needs。In above screen, the mnemonic symbol is the ―Code‖ box.

Caution：in software, the user must setup the mnemonic symbol。

 Click ―Save‖.

4.4 User Management

4.4.1 User management screen

In the main screen, click ―Maintenance‖ menu, in which click ―User‖ or click the icon
in toolbar，displays the User screen：

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4.4.2 Add new user method

 Click ―Add‖。
 Write User name。
 Write password。
 Write confirm password（repeat password）。
 Setup Right，Operator or Administrator。
 Click ―Add‖。

Hint：current user defaults as the tester。

4.4.3 Change user password

 Click the user to be changed。

 Click ―Change Password ‖，displays ― change password ‖ box as below。

 Password modification finished，click ―OK‖。

4.4.3 Delete User

 Click the user to be deleted。

 Click ―Delete‖。

4.5 Test

4.5.1 Test screen

Click the icon in toolbar，the test screen as above, refer figure above.

4.5.2 Set test setup

 Setup a few tests

- Put the sample into the tube position on the rack.
- Check the reagent volume

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- Double click the item to be tested, when the waiting appears in the column of item
（waiting to be tested）,which shows the item is selected.

- Click ，then begin test.

- Click ，the testing will be cancelled.

 Batch Test Setup
- Put the sample into the tube position on the rack.
- Check the reagent volume.
- Click ―Batch‖ on test screen, displays ―Batch test‖ dialog box。

- In batch test dialog box, the user can make setup for sample position、Test ID、Test
List、and test mode。
① In sample Position box, the start number and end number correspond to the
sample number respectively；
② In test ID box, the user can set a number for the first sample（the other
samples will be given number automatically by system） ；
③ In ―test list‖ box, Click the selected item，before which the small box shows a
tick ―√‖，which shows the item is selected；
④ In test Mode box, ―by sample‖ means sample will be priority during test，after
finishing the selected items of current sample, then begin the next selected
items of sample。―By test‖ means after finishing the current item of all samples,
then begin another item of all samples。

- Click , batch setup finished.

- Check the setup information，the test ID can not be same in one day.

- Click ，begin test.

- Click ，the test will be cancelled.

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4.5.3 Modify test setup

 Modify test ID
- Double click the test ID which needs to be modified ， the box is like the

following , in which user can input information。

- Input the correct test ID by keyboard.

 Modify test item：double click the selected item，the current item will be cancelled。

4.5.4 Delete test setup

 ―Batch Cancel‖ setup

- Click ―Batch‖ on test screen, displays ―Batch Test‖ dialog box。

- Setup the sample position、test ID、test list、and test mode which are going to be
deleted。

- Click the icon，the ―batch cancel‖ finished.

- Double click the selected test item，which can be cancelled.

4.5.5 Adding a test setup during test

Please refer to 4.5.2

4.5.6 Machine Observation during Test

Please refer to 2.4.6

4.5.7 Emergency test

- Click mouse right button on the sample ID that you want set it emergency.
- Here the user can set the emergency sample ID、 （that is the number on the rack

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where the sample put）

、the specimen ID and the test item。

- Click ，the emergency position set successfully。The emergency will be

priority during test。

4.6 Information Record

4.6.1 Patient information screen

Click the icon，user can see the patient information screen，displays the patient
information screen。

4.6.2 Record Method

We recommend a simple way, recording the patient information by pressing enter

button。On patient information screen，the cursor defaults in ―Test ID‖ box（the test ID given
from No.1 everyday） ，press ENTER button，the cursor goes into the next box，input
information by keyboard，press ENTER button again，and continue the work like above
process。When the cursor reaches ―Save‖，press ENTER button, the current information will
be saved in computer。Then the cursor back to― Test ID‖ and test ID plus 1 automatically。

4.7 Quality Control

4.7.1 Quality Control Screen

Click the icon in software toolbar or ―quality control‖ in menu, displays QC screen。

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Test item

QC curve sheet

QC results

4．7．2 Quality Control Method

 Dissolve quality control plasma.

 Check the reagent volume of each item.
 Pour the dissolved QC plasma into a tube，normal QC put into NO.1 position in tube
rack, patient QC put into No.2 position in tube rack.。
（If not to do patient QC，No.1
position of tube rack should be placed normal QC only，and No.2 position of tube rack
is empty）.
Caution！Here please use the tube rack of 2.7ml 。
 Choose the QC item which is ready， in ―QC item‖ box，click the small box before the
item，after the item is chosen，the box shows a tick―√‖。
 Choose the QC type，as above screen in QC type box。QC type includes N-test and
P-test。

 Click , starts quality control。

 Cancel the QC by Clicking 。

4．7．3 Confirm a QC Result

When QC finished，the results will be shown in ―QC results‖ as above screen。Confirm by

clicking ―Save‖，confirm the save is successful。

4.7.4 Query QC Value and Curve

 In test item box as above screen，choose an item，e.g. PT，displays screen as below.

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 Click ―OK‖，the QC curve which is accordant with the time will be displayed in ―QC
curve sheet‖。In addition，the daily QC result will be displayed in ―QC result‖ section，
including the corresponding ―Average‖ and ―SD‖ result.

Caution！A thirty-one-day’s QC value and curve are displayed once at most。

4.7.5 Deleting a quality control result

 In ―Last Result‖ box，click the QC value which has to be deleted。

 Click ―Delete‖，the value is deleted。

4.8 Calibration

4.8.1 Calibration Screen

Click the icon in toolbar or ―Calibration‖ in menu，displays calibration screen。

Calibration curve

Test item

Cali. result

Cali. Info.

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4.8.2 FIB Calibration Method

-- In test item box

-- Dissolve calibration plasma, ready for use, put 4 tubes into tube rack from No.1 to No.4, and
dilute calibration plasma manually as following:

Dilute. Ratio Plasma + Buffer

2c 50ul+200ul

c 50ul+450ul

c/2 50ul+950ul

c/3 50ul+1450ul

C is FIB plasma content

-- Check the corresponding reagent volume.

-- Click button, start reagent calibration.

-- Click Pause, the calibration is interrupted, now ― Pause‖ button turns to ― Resume‖, click it
again, the calibration will be going on.
-- Click Stop, the current calibration will be cancelled.
PT Calibration Method
-- In test item box, choose PT as FIB.
-- Dissolve calibration plasma, ready for use, put 4 tubes into tube rack from No.1 to No.4, and
dilute calibration plasma manually as following:

PT Dilution

Dilute. Ratio Plasma + Saline

100% 400ul

75% 300ul+100ul

50% 200+200ul

25% 100+300ul

-- Check the corresponding reagent volume.

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-- Click button, start reagent calibration.

-- Click Stop, the current calibration will be cancelled.

4.8.3 Validating a calibration

 The calibration finished，the time results of corresponding concentration are displayed

in the box of ―Results‖。
 To see the correlation of the current calibration（which is displayed in correlation box），
If past 0.98，the curve is advisable。
 Click ―Save‖。
 Validate the calibration curve。

4.8.4 Changing the calibration curve

 According to the above―4.8.2 calibration method‖，redo calibration。

 Input the time of corresponding concentration in the box of ―Results‖ manually。
 According to―4.8.3 validating a calibration‖，validate the calibration curve。
Caution! When doing calibration, please use the tube rack of 2.7 ml.

4.9 Query Results

4.9.1 Query Screen

Click the icon in toolbar，displays the query screen.

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4.9.2 Query method

 The user can query information by ―General‖、―Date range‖、―Receive‖、and ―Verify

status‖ in query condition box 。

 Click 。The information will be displayed on the right。

Test ID

information

Test result

 Click any row in test ID information section，the detailed test results will be displayed in
test result section。
 In ―test result‖ section，the user can delete any result which doesn’t accord with
requirement. The deleted result will not be displayed in printed report。

4.10 Result verification

4.10.1 Single verification

 On the query screen.

 In ―test ID information‖ section, select a test ID which is to be verified。

 Click 。

4.10.2 Batch verification

 On the query screen.

 In ―test ID information ‖ section, select the test ID which are to be verified，click the first
information which is to be verified，press ―Shift‖ button，click the last information which
is to be verified, then the all information which is to be verified is selected。

 Click 。

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4.11 Results printing

4.11.1 Single printing

 On the query screen.

 Click 。

4.11.2 Batch printing

 On the query screen.

 In ―test ID information ‖ section, select the test ID which are to be printed，click the first
information which is to be printed，press ―Shift‖ button，click the last information which
is to be printed, then the all information which is to be printed is selected。

 Click 。

4.12 Print report

When query finished，click ，the query results can be saved at a ((catalog)) in the

computer hard disk by the format of .txt。Every saved path defaults as the last saved catalog。

Appendix：the use of report Creator

E.g. for standard template edit：

1． Open report creator.

After SF-8050 software installed，the report creator is also installed with system。Click ―start‖,
in ―program‖ select Report Creator。

Report Creator screen：

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2． Open standard template。

Click the icon，in template under SF-8050 installation directory，choose and open
Report0.rpt document。In which the Report0.rpt is standard template，the Report1.rpt is simple
template and the Report2.rpt is compact template。

Open the screen：

3． Edit
On the screen, the user can move the contents to their desired location。The user can press the
arrows of up、down、left and right on the keyboard to perform the movement。

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Modify contents：user can only change the dark words on the screen。Double click the dark
words to perform modification。User can also change the font in the font dialog box。
Add words：click the icon in toolbar，choose the location and double click and then add
words。
Add a circle：click the icon in toolbar。
Add a rectangle：click the icon in toolbar。
Add a line：click the icon in toolbar。
Add a picture：click the icon in toolbar，choose the location and double click 。
Group contents：choose the all contents which need group，then click mouse right button and
choose ―Group‖。
Ungroup：choose a group and click mouse right button then choose ―Ungroup‖。
4． Save
Click ―file‖，choose ―save as‖。
5． Choose ―apply‖。
In the report setup location of SF-8050 software，user-defined the path 。click ―apply‖ and
―OK‖。

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