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20. PRECAUTION

13. . After test completion and removal of cartridge, inspect the cartridge for symptoms.

If any of the following symptoms occur, repeat the test to confirm validity of the result.

14. Besides, when any kind of errors happen as specified in the manual, refer

to the troubleshooting instructions from the analyzer instruction for use.

1) If the bead window is not colored uniformly.

2) If Reagent is left in the cartridge not be absorbed

fully into absorption pad.

3) If bead is not accumulated fully in the bead

window. If the bead is accumulated just like

half sized an so on.

4) If the cartridge has residue or some scratch

on the bead window.

Bead Window

Absorption Pad

21. SYMBOL & DESCRIPTION

This prodect fulfills the requirements of Directive

98/79/EC on in vitro diagnostic medical devices

Consult instructions for use.

In vitro

diagnostic medical device.

Catalog number

Used by

Batch code

Authorised representative in the European

Community.

Caution, consult accompanying documents

Symbol Description

Manufacturer

Serial number

Содержание Infopia Clover A1c

Страница 1: ......

Страница 2: ...IPTION 7 LIST OF ICONS 8 INSTALLATION 9 OPERATION 10 SETTING THE ANALYZER 11 TESTING HbA1c 12 REVIEWING RESULTS 13 CHECKING THE SYSTEM 14 OPTION 15 TROUBLESHOOTING 16 SPECIFICATION 17 MAINTENANCE 18 S...

Страница 3: ...ermined by the measurement of Hemoglobin A1c The ADA American Diabetes Association recom mends measurement of the Hemoglobin A1c levels of two to four times per user with less frequency in patients wi...

Страница 4: ...F and at a relative humidity between 10 to 90 1 CLOVER A1c Analyzer 2 Instructions for Use 3 Exclusive Power Adapter 4 Fan Filters 5 Daily Check Cartridge 6 Monthly Check Cartridge WARNING Do not modi...

Страница 5: ...alyzer Insert Reagent Pack Insert Check Cartridge Insert Check reagent pack into the analyzer Insert Check Reagent Pack Analyzer is under Check Mode Insert Check Cartridge into the analyzer 7 LIST OF...

Страница 6: ...n disturb internal calibrated optics and electronics or cause other damages Always handle the system with care The CLOVER A1c Self is a precision system and must be handled accordingly Connect the Sys...

Страница 7: ...CLOVER A1c performs hardware functionality test to verify that the internal optics and the mechanical system are operating correctly 13 03 30 AM10 00 Set up Memory DATE yy mm dd TIME 12h 13 03 30 AM...

Страница 8: ...ed by pressing the Gor then press 10 SETTING THE ANALYZER Printer mode Once the printer option is selected choose either Automatic or Manual by pressing the Gand Garrows Automatic Result is printed au...

Страница 9: ...he Warming up PROCEDURE Test Procedure STEP 1 Warming up While warming up the CLOVER A1c performs hardware funtionality test to verify that the internal optics and the mechanical system are operating...

Страница 10: ...nalyzer The cartridge is designed to fit only in one way 13 03 30 AM10 00 13 03 30 AM10 02 13 03 30 AM10 02 Gently mix the reagent pack 5 6 times before applying blood sample STEP 5 1 Apply the blood...

Страница 11: ...trate or sodium fluoride oxalate as anticoagulants can be used Venous whole blood can be stored at 2 8 36 46 for 7 days with unbroken seal only 3 days when seal is broken and at 20 25 68 77 for 3 days...

Страница 12: ...easuring time is 5 minutes and the test result will be displayed in or mmol mol STEP 8 After the test is completed open the analyzer lid Remove cartridge will be shown Remove the test cartridge from t...

Страница 13: ...08 AM10 08 Test OK Cartridge 13 03 30 13 03 30 CODE OK 3961 11 TESTING HbA1c Limitation of Procedure The CLOVER A1c assay gives accurate and precise results over a range of total Hemoglobin of 7 to 20...

Страница 14: ...y then press STEP 1 Set up Memory 12 REVIEWING RESULTS The test results will appear chronologically starting with the most recent date Press the Gand Gbuttons to scroll through STEP 2 13 11 02 PM12 05...

Страница 15: ...before use Precautions Warnings For In Vitro Diagnostic use Do not use the Check Cartridge beyond the expiration date printed on the Check Cartridge Label and Pouch Do not use the Check Cartridge if s...

Страница 16: ...mode press Gfor 3 seconds 13 03 30 13 03 30 13 03 30 13 CHECKING THE SYSTEM 4 Close the lid The test starts automatically 5 After 1 mimute OK or error message will be displayed 6 Press and remove the...

Страница 17: ...se the Monthly Check Cartridge When there is a concern that the test result may be incorrect After an error message Er 4 or Er 5 Once a month before samples are tested The Monthly Check Cartridge used...

Страница 18: ...wait until they disappear 6 Close the lid The test starts automatically 13 03 30 13 03 30 13 03 30 13 CHECKING THE SYSTEM 7 After 5 minutes OK or error message will be displayed 8 Press and remove the...

Страница 19: ...technical support 1 Open the lid of the CLOVER A1c analyzer How to test with the Control Solution 3 Mix the reagent pack gently 5 6 times and touch softly the control solution with the tip of samplin...

Страница 20: ...esh bottle of control solution Contact your local representative for customer support 5 9 41 mmol mol No 030 13 11 02 AM11 45 ID 14 OPTIONS Printer in manual mode STEP 1 Press the printer button after...

Страница 21: ...analyzer is pre set to use the barcoding system appropriately during the set up process Please refer to page 20 The barcode scanner can be used to scan the patients ID All the patients information is...

Страница 22: ...e label The background reflection is too high or low 13 03 30 14 OPTIONS STEP 1 Connect the USB Cable from the analyzer to the PC while in stand by mode STEP 2 Once connected the analyzer will display...

Страница 23: ...cognize the solutions within the reagent pack The reagent pack may be damaged and leak reagent solution Please press button and remove the cartridge Insert a new test cartridge and perform the test ag...

Страница 24: ...dge Test or Monthly Check Cartridge Please press mode button and remove the cartridge Check whether the cartridge is reused or not Insertanewcartridgeandperformthetestagain If the problem persists con...

Страница 25: ...knobs to rotate the cartridge compartment forward STEP 3 Dampen a sponge swap with water or ethanol STEP 4 Gently wipe the cartridge compartment Be careful not to drip any liquids into the system Clea...

Страница 26: ...he analyzer with any metallic or inflammable materials 9 Keep away from strong electromagnetic fields 10 Do not install near any potential electromagnetic sources 19 DISPOSAL Analyzer must be disposed...

Страница 27: ...The bead inside the Reagent Solution of the Reagent Pack might sink and coagulate Gently mix the Reagent Pack before testing and visually check that the beads are not coagulated 10 50 Check Reagent S...

Страница 28: ...e cartridge not be absorbed fully into absorption pad 3 If bead is not accumulated fully in the bead window If the bead is accumulated just like half sized an so on 4 If the cartridge has residue or s...

Страница 29: ...56 21 SYMBOL DESCRIPTION Date of Manufacturer Keep away from sunlight Do not reuse Direct Current Waste Electrical and Electronic Equipment Symbol Description Biohazard...

Страница 30: ......

Страница 31: ...FH02B OSANG Healthcare Co Ltd 132 Anyangcheondong ro Dongan gu Anyang si Gyeonggi do Korea 14040 www osanghc com Obelis S A Bd General Wahis 53 1030 Brussels Belgium Tel 32 2 732 59 54 Fax 32 2 732 60...

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