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SF-8200 Operation Manual 

                           

 

 

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76

 

 

QUALITY COMMITMENT 

 

  The company's manufactured products undergo a rigorous quality inspection, would be in full com-

pliance with the technical requirements of this product   

  The analyzers pass the safety testing and performance testing of medical device testing agencies, 

they would be in line with national standards and industry standards     

  The product is manufactured under the quality system conforming to ISO13485 and ISO9001. The 

quality system of our company is certified by TUV 

  The device complies with the emission and immunity requirements of GB / T18268.1-2010 and GB / 

T18268.26-2010 

  This equipment is designed and tested according to Class A of GB4824. This equipment may cause 

radio interference in home environment and need protective measures 

  It is recommended to evaluate the electromagnetic environment before using this equipment 

  Do not use the device near strong radiation sources (such as unshielded RF sources), otherwise it 

may interfere with the normal operation of the device 

  The company product’ design life is 5 years, one year warranty and lifetime maintenance.

Содержание SF-8200

Страница 1: ...Automated Coagulation Analyzer SF 8200 PLEASE READ THIS MANUAL CAREFULLY BEFORE OPERATION Beijing Succeeder Technology Inc www succeeder com cn service succeeder com cn Effective Date 01 12 2017 SUCQ...

Страница 2: ...ngxin Road Tech Park Changping District Beijing 102200 China Tel 86 10 53855569 Fax 86 10 53855570 www succeeder com cn service succeeder com cn INFORMATION ABOUT AUTHORISED REPRESENTATIVE NAME Wellka...

Страница 3: ...TRUMENT COMPOSITION 11 3 2 Specifications 14 4 ANALYSIS PRINCIPLE 16 4 1 SOLIDIFICATION TEST SYSTEM DESCRIPTION 16 4 2 OPTICAL METHOD TEST SYSTEM DESCRIPTION 16 4 3 TEST PROCESS INTRODUCTION 17 II ROU...

Страница 4: ...Y CONTROL PARAMETERS ENTRY 45 5 REAGENT LOADING 45 5 1 AUTOMATICALLY SAVE AND LOAD REAGENT LAYOUTS 45 5 2 REAGENT LOADING UNLOAING 46 QUALITY CONTROL 47 1 QC SETTING 47 2 QC TEST 48 3 INQUIRE THE QUAL...

Страница 5: ...SETTING 66 4 2 REAGENT AREA POSITION CHECKING 66 4 3 SETTINGS FRO DIPOSE THE CUVETTE WHICH LACK REAGENT 66 4 4 SETTINGS FOR CALCULATE THE MEAN VALUE AUTOMATICALLY 66 5 SYSTEM INFORMATION 67 5 1 INSTRU...

Страница 6: ...001 The quality system of our company is certified by TUV The device complies with the emission and immunity requirements of GB T18268 1 2010 and GB T18268 26 2010 This equipment is designed and teste...

Страница 7: ...linical test results and other test results at the same time 2 NOTES ON THE USE OF BIOLOGICAL PRODUCTS For all biological products reagents calibrators quality control plasma and patient plasma etc pl...

Страница 8: ...n use the UPS regulator you cannot use the ordinary regulator 4 NOTES FOR PREPARING THE TEST 4 1 SAMPLE PREPARATION 1 Selection and dosage of anticoagulants Anticoagulant 105 109mmol L 3 13 3 2 usuall...

Страница 9: ...method of reagent determi nation of the box the use of different batches and manufacturers of reagents need to do calibration coagulation test for calibration Calibrators must be used different batch...

Страница 10: ...chnology Inc profes sional engineers or by the Company authorized engineers to install at the same time the initial set After the instrument is installed and running it should not be moved normally If...

Страница 11: ...98 ME WINNT4 WIN2000 WINXP WIN7 WIN10 8 Avoid direct heat and light exposure WARNING Make sure the instrument is grounded Improper grounding may cause electric shock 2 4 PERIPHERALS 1 The computer sys...

Страница 12: ...dow the need to open the tool 4 Power switch and interface Use the power cord provided by the manufacturer to power the instrument Turn on the power Turn off the power WARNING TO PREVENT ELECTRICAL SH...

Страница 13: ...ectly at the light beam 9 In outflow port Waste liquid connection interface with liquid waste alarm indicator light full liquid switch to con nect the faucet and alarm connector Cleaning liquid connec...

Страница 14: ...possible heat burns on the surface of the reagent needle Use caution 3 Sample arm Independent loading arm for sample and intermediate reagent loading the operating area for the reagent reagent in the...

Страница 15: ...sample needle and reagent needle With condensate collection and discharge function to improve the reagent position in high temperature and humidity environment stability 7 test positions Solidificati...

Страница 16: ...n AT s OD min 3 sample volume range 5 l 250 l 4 carrying pollution rate FIB high concentrations of low concentrations of carrier pollution should be 10 FIB or TT on PT or APTT carrier contamination ra...

Страница 17: ...sity of the plasma is detected by the curved movement of the test bead at the base of the cuvette Independent coils on both sides of the cuvette generate opposite electromagnetic fields that drive the...

Страница 18: ...he sample needle to absorb the corresponding reagent added to the test cuvette co incubation tem perature The sample needle will be properly cleaned after each pipetting step When the incubation time...

Страница 19: ...into the rubbish box the garbage basket pushed back to the instrument Note Please reserve enough space on the right side of the instrument to facilitate the re moval of rubbish baskets Instrument has...

Страница 20: ...cet if not in place will cause drainage blockage cannot be discharged in time leading to overflow within the instrument Check the cleaning liquid tank If the liquid level of the cleaning liquid is low...

Страница 21: ...l it on the cuvette plate support limit block and install the cuvette band on the take up pulley under the cuvette belt limit pulley 4 Push the cuvette holder back into the instrument compartment to m...

Страница 22: ...are for the first time the user name is admin and the login password is blank You can change the login name and login password on the Settings screen after login Specific operations see Chapter VII 1...

Страница 23: ...nd an icon is displayed to display the corresponding menu Sample loading interface Reagent loading interface Test interface Results screen interface Calibration interface Control interface Test start...

Страница 24: ...2 70 l 85 l AT AT buffer 45 l 186 l AT Thrombin Reagent 155 l AT substrate 45 l 55 l SFW cleaning liquid Dosage is about 200ml per test regarding seven items Considering that not all of the reagents i...

Страница 25: ...t name reagent name batch number loading time and expiration date in order according to the loading reagent information Click the confirm button the product information column shows the set content th...

Страница 26: ...ment will automatically open the reagent barcode scanner scan reagent bottle label bar code Within 5 seconds put the reagent into the corresponding area the system can automatically iden tify and set...

Страница 27: ...selection needs to be viewed 4 Click the curve interface will appear calibration curve graphics and related data 5 Make sure to select the correct calibration curve consistent with the batch number o...

Страница 28: ...interface 3 Click the Quality Control Test button pop up quality control test setting interface 4 Select the required quality control batch number and test items to determine the quality control task...

Страница 29: ...b the blood cell layer the plasma residue can not be less than 150 l the total plasma of not less than 410 l about 5 5mm liquid height If do repeat analysis then double the sample amount Note The abov...

Страница 30: ...e scanner reads the sample information perpendicular to the sample bar In order to ensure the success rate of barcode scanning the sample bar should not be pushed too fast 1 8mW 120 s 405nm 2 GB7247 1...

Страница 31: ...st tube occupy the hole To set a sample enable the sample number fill in the sample information or code by ticking the checkbox as shown to the right 3 Confirm the sample information is correct set th...

Страница 32: ...o load the sample automatically Or in the software sample interface manually load the sample Click the sample bar when it is selected the solid border will display Click Load the Sample Load dialog bo...

Страница 33: ...test dedicated vacuum blood collection tube 2ml or 3ml specifi cations Micro tube 1 5ml trace tube Warning When testing with the specified micro tube the sample tube holder should be used as it will...

Страница 34: ...y check the test items set by the default grouping 3 Delete the group Select the right side of the box any one group click delete button H Repeat the test Set the number of times all the selected samp...

Страница 35: ...e Load window to test it as an emergency marker During the test you can also convert a normal sample to an emergency by simply selecting Con vert to Emergency in the right click menu in the sample are...

Страница 36: ...the sample click Start button to start the test task WARNING Do not place your hands or fingers in the instrument while the instrument is testing as this may result in personal injury If you open the...

Страница 37: ...ches In the test mission display area click the right mouse button pop up menu select batch cancel Through the Batch Cancel window set the cancellation range test items The serial number is the serial...

Страница 38: ...details Through the task details window data acquisition and analysis curves can be monitored in real time and test start time end time incubation channel number test channel number and reagent status...

Страница 39: ...ults of the previous day you can toggle the date by the button below the list or view the day after results and use the button to toggle the date If the query time is longer by clicking on the test da...

Страница 40: ...howing the measured value the user can check the corresponding serial number identified as the report of the results if the check multiple results then check the results of the last one to report the...

Страница 41: ...ith the collected data and may result in incorrect test results Exercise caution when performing this operation and only administrator users can perform sample modifications 3 3 SAMPLE RESULT REVIEW S...

Страница 42: ...after clicking the Print button 1 Print a single sample result The mouse selects the sample information to be printed in the left sample list Click the Print button in the result operation area to pr...

Страница 43: ...onsecutive sample results Use the mouse to select the first sample information to be printed in the left sample list Press the SHIFT key use the mouse to select the last sample information to be print...

Страница 44: ...reagent lot numbers entered on the left are displayed Product Name Select the reagent name through the drop down menu batch number fill in reagent lot number Manufacturer Choose a reagent supplier Bot...

Страница 45: ...view the supplies margin Click Start Scanning and then place the prepaid card in the swipe card area After the operation is successful the buzzer sounds to remind you to complete the recharge 2 suppl...

Страница 46: ...item of the quality control and save it to the left item list 5 After all required reagent information has been input click OK to return to the Lot No manage ment dialog box and click Save to finish...

Страница 47: ...2 Recharge reagent When the reagent is not enough click Reagent button on the Reagents interface The device is halted after a brief interruption In this case open the front cover and load the require...

Страница 48: ...the QC test the QC used for the test item needs to be specified 1 Select the test items in the left test item list area 2 Click the Settings button pop up project Quality Control Settings dialog box...

Страница 49: ...ntrols loaded you can conduct quality control tests For details please refer to chapter two 3 INQUIRE THE QUALITY CONTROL RECORD Check the QC chart in the software QC interface 1 Click the test item i...

Страница 50: ...8200 Operation Manual 49 76 4 Select quality control test results double click to view the test task Or delete the QC result by Delete button 5 Click Print button pop up print report preview dialog b...

Страница 51: ...Refer to chapter 2 2 CREATE A CALIBRATION CURVE 2 1 SET THE CURVE PARAMETERS Before creating a calibration curve you must first set the curve parameters for the test item 1 Take the FIB test item as...

Страница 52: ...ion requires at least 3 points and the calibration requires at least 3 points To ensure the accu racy of the test results according to the test items and reagents required to set the appropriate numbe...

Страница 53: ...ated Select the calibration method there are two ways of automatic dilution and analysis and manual input 3 Automatic dilution and analysis New calibration curve select automatic dilution and analysis...

Страница 54: ...rve applied as a valid curve changes from green dot to red dot in front of the list thus completing the creation of a new calibration curve 4 manual input When calibrator is used as sample test the te...

Страница 55: ...tion dialog box to store calibration data Apply newly added calibration curve 3 MODIFY THE CURVE 1 Select the calibration curve on the left list 2 double click the curve data display area measurement...

Страница 56: ...late through the small program Report Editor in the installed software 1 2 USER SETTING 1 User Type User types are divided into three These three can be sorted from highest to lowest according to oper...

Страница 57: ...ded to set a new pass word after login Password Setting Options interface In the user list of General select the user who needs to change the pass word Click Change The following dialog box will pop u...

Страница 58: ...a byte is maximum one 2 When test item is LIS code set the path to Options Tests Lis Code ASTM Protocol Type Standard ASTM protocol type is used Please refer to the protocol file provided by the Insta...

Страница 59: ...t test items The instrument supports three methodologies clotting immunoturbidimetry chromogenic substrate method Clotting test method uses mechanical methods immunoturbidimetry and chromogenic substr...

Страница 60: ...test project please contact the factory service 1 Add Test Procedure Select the test items that need to be modified in the test list Click New Procedure Process Definition dialog box pop up Sample Ad...

Страница 61: ...ems and reagents requirements Mix after loading by the way of stiring and aspirating and discharging Select aspirating and discharging Mix time After aspirating and discharging a completed calculation...

Страница 62: ...ng point This point is the first time point after the mixes and stabilizes and begins to react Second sampling point This point is the shortest time point for the measured object to react smoothly or...

Страница 63: ...lue According to the main unit choice the setting value is also different Automatic Dilution Check the Auto Dilution check box the system will automatically run ac cording to the results of heavy dilu...

Страница 64: ...ected unit expression and fill in the normal or negative range of test results Check the printout check box you can display the results of the unit test results and print upload Check the Show checkbo...

Страница 65: ...sts tab click on the external and then pop up the dialog box Fill in the test code test name result unit and reference range After clicking Add a new test item will be displayed in the list on the lef...

Страница 66: ...isplayed in the left list 2 Add dictionary content Select the name of the dictionary in the lower list In the Code edit box fill in the corresponding content In the Description edit box to fill in the...

Страница 67: ...sition Therefore please set the reagent hole manually Please refer to Chapter2 to set the reagent hole manually 4 3 SETTINGS FRO DIPOSE THE CUVETTE WHICH LACK REAGENT In the Device tab of the Options...

Страница 68: ...he temperature to differ from the temperature required by the instrument s performance standards This is due to the temperature difference caused by system temperature compensation 2 Instrument serial...

Страница 69: ...e date range search the log information 2 Log Type System log Used to record all the fault information in the process of using the system Operation log Used to record all operational information in th...

Страница 70: ...the service department of SUEECSS or local agent Monthly Test channel maintenance Probes maintenance Maintain pipes Check the hook module Check the FFC Check the location function Keep the machine cl...

Страница 71: ...the probes inside and outside wall If there are stains on the surface outside the probes wall after rinse please wipe them up and down with gauze or tissue paper soaked by 75 medicated alcohol 4 Clean...

Страница 72: ...tical jetted then add the needle unobstructed Otherwise if the water column is too thin or skewed and other anomalies that means the needle is blocked and it need be cleaned Use the needle in the atta...

Страница 73: ...tion and maintenance install the manipulator and check the positioning in the debugging software If there is any deviation you need to reposition 5 FFC cable maintain Check the FFC cable repeatedly cu...

Страница 74: ...r on the right side of the middle reagent position and the filter on the left side of the reagent position Remove the filter and clean the surface dust Install the clean filter back to its original po...

Страница 75: ...n fuse close the fuse box window and fix it with the tool Attention When the instrument is switched on do not operate on the circuit board After the instrument is powered off wait at least 15 seconds...

Страница 76: ...3 Failed to connect the reader Possible Causes IC card reader interface is not connected well Solution Exit the software re plug the USB cable on the left side of the instrument and log in to the sof...

Страница 77: ...ty should be suitably adjusted Meet the humidity requirements of the working environment of the instrument is 30 75 Add reagent 7 Cuvette position sensor failure Possible Causes Cuvettes run out Cuvet...

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