Succeeder SF-8100 Manuale utente

Beijing SUCCEEDER Technology Development Co., Ltd.

SF-8100 Automated Coagulation Analyzer

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

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

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:

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;

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.

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

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.

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

Normal sample

Abnormal sample

≤3&%

≤8%

APTT

≤4%

≤8%

FIB

≤8%

≤15%

≤5%

≤10%

D-Dimer

≤8%

≤6%

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