Succeeder SF-8100 User manual
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Beijing SUCCEEDER Technology Development Co., Ltd.
SF-8100 Automated Coagulation Analyzer
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1. Table of Contents
1. Table of Contents................................................................................................................................2
2. Warnings and Cautions ...................................................................................................................5
2.1. General Warnings...........................................................................................................................5
2.2. Safety of Login ..............................................................................................................................5
2.3. Warning before use ........................................................................................................................5
2.4. Quality Commitment .....................................................................................................................6
3. Circuit diagram and description.....................................................................................................7
3.1. Power module ................................................................................................................................7
3.2. Movement module .........................................................................................................................8
3.3. Sensor module................................................................................................................................8
3.4. Liquid flow module........................................................................................................................8
4. Technical specification ...................................................................................................................10
5. Description of device......................................................................................................................11
5.1. Intended Use ................................................................................................................................11
5.2. Application...................................................................................................................................11
5.3. Principle of clotting method.........................................................................................................11
5.4. Chromogenic substrate method....................................................................................................12
5.5. Immunoturbidimetric Method......................................................................................................12
5.6. Procedure Description..................................................................................................................13
6. Installation instruction...................................................................................................................14
6.1. Appearance; .................................................................................................................................14
6.2. Parts Description:.........................................................................................................................16
6.3. Cuvette supply system; ................................................................................................................19
6.4. Carry-Handles;.............................................................................................................................20
6.5. Work platform requirement;.........................................................................................................20
6.6. Unpack machine...........................................................................................................................21
6.7. Parts Release................................................................................................................................23
6.8. Connection...................................................................................................................................25
6.9. Cuvette rolls Installation..............................................................................................................26
6.10. Connect to computer. ...................................................................................................................28
6.11. Software installation. ...................................................................................................................29
6.12. Software introduction...................................................................................................................33
6.13. Routine test ..................................................................................................................................34
7. Maintenance ...................................................................................................................................36
7.1. Environment: ...............................................................................................................................36
7.2. Placement:....................................................................................................................................36
7.3. Communication analyzer .............................................................................................................36
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7.4. Daily maintenance .......................................................................................................................38
8. Storage ............................................................................................................................................39
9. Troubleshooting..............................................................................................................................40
10. Symbols...........................................................................................................................................44
11. Circuit description & map.............................................................................................................45
12. Special tools ....................................................................................................................................46
13. Spare part list .................................................................................................................................47
14. Index................................................................................................................................................48
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Thank you for purchasing our product
Read this manual carefully before use.
Model: SF-8100
Name: Automated Coagulation Analyzer
Manufacturer: Beijing Succeeder Technology Development Co., Ltd
Service hotline: Please contact with local authorized representative.
Fax: +86 -10-89701711
Address:Tower 1A, No. 27 Chuangxin Road, Changping District, Beijing 102200, China
Postcode: 102200
http://www.succeeder.com.cn
Service e-mail: aftersales@succeeder.com.cn
INFORMATION ABOUTAUTHORISED REPRESENTATIVE
Name:
Tel:
Fax:
Address:
Please send us information below for better service.
User Name:
Laboratory Name:
Instrument SN No:
Operator:
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2. Warnings and Cautions
2.1. General Warnings
Read before first-use or installation. Failure to follow the recommended instructions will
adversely affect the safety and effectiveness of the SF-8100 analyzer system.
Succeeder shall not be held responsible if the procedures described in this manual are not strictly
observed, or if procedures not described in this document are used. Read the SF-8100 Operator’s
Manual carefully and respects all the instructions given therein.
With regard to the handling of test reagents, calibrator plasmas, control plasmas and patients’
plasmas, read carefully the package inserts provided in the relevant reagent kits and respect all the
instructions.
2.2. Safety of Login
When first login SF-8100 software, user name and password as below:
User Name: admin
Password: “no password”
Password is suggested to be modified when first login.
2.3. Warning before use
Protective earth terminal is required. The earth terminal of instrument has a sign of
“ “which should be connected to earth. Leakage protector is also required when there is
an in humid environment.
The instrument label contains device Name, model, company name, SN number, voltage, HZ,
KW, etc.
Pay attention to the sign” ”, read its relevant details in operation manual before use.
Once machine was installed, don’t move it without fixing parts.
Closed upper cover for safety before testing. If running for 24 hours without switching off,
click “Rinse” before test since 30 minutes from last test.
Do not disassemble repair for safety unless it is mentioned in operation manual.
Avoid to potential infection from sample, please use gauntlet or safety measures during
operating. Please deal with the waste follow local medical waste policy.
Our product was designed to work indoor.
No EMI, strenuous vibration, or corrosive gas nearby.
Indoor temperature within 15℃～30℃, relative humidity below 70％, ATMOS 86.0 kPa～
106.0kPa;
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For unpacked machine: Indoor temperature -20℃～55℃, relative humidity below 93%, no
corrosive gas and drafty indoor.
Not apply in damp environment.
Power supply must be grounded firmly. A leakage protector is needed in damp environment.
Our product was designed with power stabilizer. UPS was recommended when the power supply
in user field was not stable that the voltage of wave
2.4. Quality Commitment
Products undergo strict quality testing, full compliance with the product register standards;
Our Products passed safety and performance testing of medical device testing institutions,
conform to national standards and industrial standards and the implementation of the EU
98/79 / EC Directive;
Our company passed the TUV, ISO13485 and ISO9001 certification;
Our product has one year warranty, and 7 years maintenance according to CE.
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3. Circuit diagram and description
The instrument is designed in a modular format consisting of a power module, movement module
and a sensor module. The electrical module contains the power supply and other boards which
contains all components,
3.1. Power module
The power module can be described in three sections: the power supply, the voltage regulator,
and the power board.
Power
system
Switch power
Power
pinboard
Communication
board Mainboard Filter board
Pump board
Motor pinboard
Motor
board
Probes
board
Hook motor
board
Reagent probe
Heating board
Optics test
board
Magnetic bead
test board
Motion control
system
Test system
Temperature&status
system
Electromagnet
control board
LED board
Electromagnet
Driving board
Temperature
Control board
Heat board
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3.2. Movement module
The movement module is a unit that contains mechanism of manipulator, arm with XYZ
direction, probes and other necessary parts.
Communication system
cuvette Temperature and
status
Sample
loading Test Clean
release
detach
move
Temp control
heat
cool
Status detection
Sample rack
Open alarm
XYZ move
loading probe
Loading pump
Magnetic bead
Optics
pipeline
Inflow/outflow
pump
3.3. Sensor module
The sensor module can be divided into three parts including test channel, temperature
board and main board
3.3.1. Test channel use mechanical method which could drive the bead inside cuvette during
test cycle;
3.3.2. Temperature board which could provide 37℃to incubation area, test area and also
reagent area to incubate samples and reagents;
3.3.3. Main board could detect and measure the bead inside cuvette, and then calculate the
right result by the bead movement.
3.4. Liquid flow module
The sample flow rate is monitored by measuring the micropipette which calibrated flow
restrictor.
Liquid flow module consists of inflow pump, inflow valve, injectors, electronic valves,
probes, pipelines, outflow pump and some other parts. It ensures correct sample
amount of the whole system.
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4. Technical specification
Type (Overvoltage category): II
Level of contamination: Level 2
Power: voltage: 100V-240V
Frequency:（50-60）Hz
Work environment: temperature: 15℃～30℃
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: Clotting method, optical method （chromogenic substrate method and
immunoturbidimetric method).
Judgment method: Eddy current sensor, optical colorimetric, turbidimetric.
SF-8100: Clotting method、optical method.
Test sample: Platelet-poor plasma using sodium citrate as anticoagulant （PPP).
Accuracy and reproducibility
Item
CV
Normal sample
Abnormal sample
PT
≤3&%
≤8%
APTT
≤4%
≤8%
FIB
≤8%
≤15%
TT
≤5%
≤10%
D-Dimer
≤8%
≤6%
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