1. INTENDED USE 3. PRINCIPLES OF OPERATION The CLOVER A1c Self analyzer is an IVD(In Vitro Diagnostic Device) device for The CLOVER A1c™ Self system is a fully automated boronate affinity assay for the measuringHemoglobin A1c by the well established method of boronate affinity. It is able determination of the percentage of Hemoglobin A1c (HbA1c %) in whole blood(capillary to analyze bothcapillary whole blood and venous blood.
Solution Cartridge Mixing 5times Code Area For use with CLOVER A1c Self Test Cartridge only For measuring hemoglobin A1c For Self-testing use 5. Storage Instructions The CLOVER A1c™Self analyzer must be stored at 10°C~35°C. Test Cartridges must Sample Collecting Area be stored at 2°C~32°C(36°F-90°F) and 10%~90% R.H( Relative Humidity)
Memory in memory. capillary tip area. Insert reagent pack with blood sample Insert Reagent Set up Select this icon to set up the analyzer. into the analyzer. Pack CLOVER A1c Self • 8 • CLOVER A1c Self • 9 •...
Connect the System Power 1. Ensure that the system power button is in the off position. 2.Connect the power code of the system to appropiately grounded AC electrical outlet. CLOVER A1c Self • 10 • CLOVER A1c Self • 11 •...
Select the time format by pressing the DATE yy/mm/dd 08 / 03 / 30 buttons, then press 12h for standard time / 24h for military time TIME AM 08 : 00 CLOVER A1c Self • 12 • CLOVER A1c Self • 13 •...
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Select whether or not to use the barcode system by pressing , then press Set up the contrast desired, by pressing the then press LCD Contrast Barcode Use Not Use CLOVER A1c Self • 14 • CLOVER A1c Self • 15 •...
Code Area of the front side, nor the bead window at the back side. Any dirt or contamination of both areas, may cause erroneous test values. Code Area IMPORTANT : Do not move the analyzer during the ‘Warming up’. Bead Window CLOVER A1c Self • 16 • CLOVER A1c Self • 17 •...
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08/03/30 AM10:02 08/03/30 AM10:02 HbA1c Glucose HbA1c Glucose IMPORTANT : After the capillary tip is filled with sample, analysis must begin within 5 minutes. CLOVER A1c Self • 18 • CLOVER A1c Self • 19 •...
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▪ Follow all hygiene and safety regulations in force locally. [ adequate ] [ inadequate ] IMPORTANT : Once the reagent pack is filled with the blood sample, analysis must begin immediately. CLOVER A1c Self • 20 • CLOVER A1c Self • 21 •...
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Do not vibrate or move the analyzer during the test. CAUTION : Do not give strong impact to cartridge. Dispose all waste in accordance with applicable national and /or local regulations. CLOVER A1c Self • 22 • CLOVER A1c™ Self • 23 •...
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Hemoglobin concentrations are outside of the acceptable range. CAUTION : Discard cartridge in proper container, according to your standard laboratory procedures. CLOVER A1c Self • 25 • CLOVER A1c Self • 24 •...
Daily check cartridge The CLOVER A1c™ Self Check Cartridge checks that the optical and operating systems of the Analyzer are working correctly. For checking CLOVER A1c Self Analyzer only. For self-testing use. IMPORTANT : Please read through and familiarize yourself with the contents of theCLOVER A1c™Self Analyzer Operation Manual before...
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NOTE : If an errer message is displayed, repeat the test. If is still displays Er 2 message ‘Do Not use the analyzer’. NOTE : To leave the Daily check cartridge mode, press for 3 seconds. Please contact your local representative for customer support. CLOVER A1c Self • 31 • CLOVER A1c Self • 30 •...
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- If Monthly Check Cartridge be reused, analyzer show up ‘Do not reuse!’. - The Monthly check cartridge can be purchased from local distributors. NOTE : To leave the Monthly check cartridge mode, press for 3 seconds. CLOVER A1c Self • 32 • CLOVER A1c Self • 33 •...
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NOTE : If an error message is displayed, repeat the check again. If it still displays error message ‘Do Not use the analyzer’. Please contact your local representative for customer support. CLOVER A1c Self • 34 • CLOVER A1c Self • 35 •...
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2) Insert the cartridge when the ‘Cartridge insert’ icon displayed. [ adequate ] [ inadequate ] IMPORTANT : Once the reagent pack is filled with the control solution, analysis must begin immediately. CLOVER A1c Self • 36 • CLOVER A1c Self • 37 •...
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- Please contact your local representative for customer support. 6) The HbA1c% is displayed after 5 minutes. NOTE : The test result should be within the range speccified on the manual of the respective control solution. CLOVER A1c Self • 38 • CLOVER A1c Self • 39 •...
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STEP 2. Connect the blood glucose Module to the port located in the front side of STEP 5. Check the applying sample blood icon on the CLOVER A1c™ Self the Analyzer. anlayzerLCD. CLOVER A1c Self • 40 • CLOVER A1c Self • 41 •...
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STEP 3. Press to select one or the other and or press • Current : Only that result will print. • ALL : Every result in memory will print. CLOVER A1c Self • 42 • CLOVER A1c Self • 43 •...
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Paper Roll - Don’t touch the print head. It can be very hot after printing continuously for a long time. - Make sure that the paper direction is correct. CLOVER A1c Self • 44 • CLOVER A1c Self • 45 •...
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Design, Specifications are subject to change without notice. Ask factory for technical specifications before purchase and/or use. Whenever a doubt arises form this products, please inform us immediately for technical cosultation without fail. CLOVER A1c Self • 46 • CLOVER A1c Self • 47 •...
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STEP 3. Download the PC application program. STEP 4. Once the program is downloaded, click the ‘Date Transfer’ icon on your PC. The results from the analyzer will be transferred over. CLOVER A1c Self • 48 • CLOVER A1c Self • 49 •...
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1 PC Cable the test cartridge and remove the cartridge. Insert a new test CLOVER A1c™ Self cartridge and perform the test again. 1 Fan fileter AC-CL0-1A2-01 Fan Filter CLOVER A1c Self • 50 • CLOVER A1c Self • 51 •...
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If the problem validate the analyzer and re-test the Er 10 auto-coding label than 4.0% persist, contact your local representa- blood sample. (20mmol/mol) tive. CLOVER A1c Self • 53 • CLOVER A1c Self • 52 •...
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If the problem still persists, does not adaptor or the PC Connection Cable contact your local representative. analyzer itself power on Thermal Printer Barcode Scanner CLOVER A1c Self • 54 • CLOVER A1c Self • 55 •...
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STEP 4. Gently wipe the cartridge compartment. Be careful not to drip any STEP 3. Close the fan filter cover. liquids into the system. NOTE Additional Fan Filter can be purchased from our representatives, nearest in your area. CLOVER A1c Self • 56 • CLOVER A1c Self • 57 •...
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EEE waste going for final disposal. before testing, and visually check if the beads are not coagulated. infopia Co., Ltd. as the manufacturer, has specific instructions for the recovery of the analyzer. Please contact our representatives in your area for the respective instructions before disposing.
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14. Besides, when any kind of errors happen as specified in the manual, refer to the troubleshooting instructions from the Analyzer instruction for use. CLOVER A1c Self • 60 • CLOVER A1c Self • 61 •...
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Waste Electrical and Electronic Equipment Serial number This symbol indicates that the system is type A equipment, which provides a particular degree of protection against electric shock. Manufacturer CLOVER A1c Self • 62 • CLOVER A1c Self • 63 •...
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