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Infopia CLOVER A1c Self, Instructions For Use Manual, Page: 1 / 33

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Diabetes Management Technology

INSTRUCTION FOR USE

        

infopia Co., Ltd.

891, Hogye-Dong, Dongan-Gu,
Anyang, Kyunggi, 431-080, Korea
www.infopia21.com

               

Obelis S.A.

Bd. General Wahis 53
1030 Brussels, Belgium
Tel : +(32) 2.732.59.54
Fax : +(32) 2.732.60.03
E-Mail : [email protected]

IMH12-008        Rev.2011-12-01

For measuring Hemoglobin A1c

For measuring Hemoglobin A1c

For measuring Hemoglobin A1c

INFH01AS

Summary of Contents for CLOVER A1c Self

Page 1: ... Gu Anyang Kyunggi 431 080 Korea www infopia21 com Obelis S A Bd General Wahis 53 1030 Brussels Belgium Tel 32 2 732 59 54 Fax 32 2 732 60 03 E Mail mail obelis net IMH12 008 Rev 2011 12 01 For measuring Hemoglobin A1c For measuring Hemoglobin A1c For measuring Hemoglobin A1c INFH01AS ...

Page 2: ...INSTRUCTIONS 6 6 DEVICE DESCRIPTION 7 7 LIST OF ICONS 8 8 INSTALLATION 10 9 OPERATION 11 10 SETTING THE ANALYZER 13 11 TESTING HbA1c 16 12 REVIEWING RESULTS 26 13 CHECKING THE SYSTEM 28 14 OPTION 40 15 PRODUCT LIST 50 16 TROUBLESHOOTING 51 17 SPECIFICATION 55 18 MAINTENANCE 56 19 SAFETY 58 20 DISPOSAL 58 21 PRECAUTION 59 22 SYMBOL DESCRIPTION 62 ...

Page 3: ...r the determination of the percentage of Hemoglobin A1c HbA1c in whole blood capillary and venous The Test Cartridge is composed of a cartirdge and a reagent pack containing the reagents necessary for the determination of hemoglobin A1c A cartridge should be inserted into the analyzer cartridge holder first and later assembled with areagent pack which was applied with 4ul blood sample at the sampl...

Page 4: ...e 6 Monthly Check Cartridge WARNING Do not modify this equipment without authorization of the manufacturer ForcheckingCLOVERA1cSelfAnalyzeronly Forself testinguse Fornotreuse ForcheckingCLOVERA1cSelfAnalyzeronly Forself testinguse Fornotreuse CLOVER A1c Self 7 6 Device Description 6 1 Analyzer 6 2 Cartridge Cover Cartridge Code Area Reaction Solution Washing Solution Printer Button Mode Button Arr...

Page 5: ...n case of daily check cartridge the iconwill not be shown up Insert Check Reagent Pack Analyzer is under Check Mode Insert daily check cartridge or monthly check cartridge into the analyzer CLOVER A1c Self 9 7 LIST OF ICONS Icon Function Name Insert the blood glucose test strip into the glucose module Insert strip Apply blood sample to the blood glucose test strip Apply sample to glucose test stri...

Page 6: ...d optics electronics orother internal parts can be disrupted or damaged Always handle the system with care The CLOVER A1cTM Self ia s precise system and must be handle carefully 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 Installing Connections 1 2 3 4 5 System Connections...

Page 7: ...device gets ready for the test Warming up will take approximately 5 minutes depending on the ambient temperature 9 2 Warming up While warming up the CLOVER A1cTM Self performs hardware function test to check internal opticsand the mechanical system CLOVER A1c Self 13 10 SETTING THE ANALYZER Date Getting into set up mode In stand by mode press the button and hold for 3 seconds Choose between set up...

Page 8: ...8 Glucose ID mg dL 137 NGSP mg dL 08 03 30 HbA1c AM10 08 Glucose ID mmol mol mmol mol 7 5 mmol L IFCC Set up the contrast desired by pressing the or then press CLOVER A1c Self 15 10 SETTING THE ANALYZER Printer mode Once the printer option is selected choose either Automatic or Manual by pressing the and arrows Automatic Result is printed automatically after each test Manual Result will only be pr...

Page 9: ...hardware funtionality test to verify that the internal optics and the mechanical system are operating correctly Warming up CLOVER A1c Self 17 11 TESTINGHbA1c Remove one pouch from storage Tear the pouch open on the side with the serrated edge DO NOT use scissors to cut open pouch Scissors can damage the reagent pack STEP 3 STEP 2 CAUTION When handling the reagent pack and cartridge be careful not ...

Page 10: ...rtridge may cause damage to the test cartridges and lead to false measurements or error messages 08 03 30 HbA1c AM10 00 Glucose 08 03 30 HbA1c AM10 02 Glucose 08 03 30 HbA1c AM10 02 Glucose CLOVER A1c Self 19 Gently mix the reagent pack 5 6 times before applying blood sample STEP 5 1 Place the blood sample up to the sample collecting area by softly touching the blood sample make sure that the samp...

Page 11: ... weeks or up to 25 C 77 F for one week Stored blood should be whole blood not as hemolysate Allow blood samples to reach room temperature 20 25 C 68 77ºF Anticoagulated blood should be mixed well prior to testing Remove the stopper from the holder and take out a drop of blood sample on a clean container Softly touch the sample collection area of the Reagent Pack on the blood sample and wait until ...

Page 12: ... level may be above 14 0 or below 4 0 repeat testing If the second result is again outside this range please contact your local customer support and service center 08 03 30 HbA1c AM10 09 Glucose Remove CLOVER A1c Self 23 CLOVER A1c Self 22 11 TESTING HbA1c Insert the reagent pack into the cartridge in the analyzer The close the cover icon will be displayed STEP 6 08 03 30 HbA1c AM10 03 Glucose The...

Page 13: ...etes Control and Complications Trial DCCT a five year progress report Clin Chem 47 1985 1992 2001 Defining the relationship between plasma glucose and HbA1c analysis of glucose profiles and HbA1c in the Diabetes Control and Complications Trial Diabetes Carel 25 275 278 2002 Perform the A1C test at least two times a year in patients who are meeting treatment goals and who have stable glycemic contr...

Page 14: ... HbA1c and Glucose then press HbA1c Glucose Memory STEP 1 STEP 2 CLOVER A1c Self 27 12 REVIEWING RESULTS The test results will appear chronologically starting with the most recent date Press the and buttons to scroll through STEP 3 Memory No 47 HbA1c 08 12 08 PM12 05 ID 7 2 55 mmol mol Memory No 46 08 11 08 PM12 03 Memory No 45 22356789012341 08 10 08 PM12 35 HbA1c ID ID 5 4 35 mmol mol 5 9 41 mmo...

Page 15: ...R A1c Self Monthly Check Cartridge Storage Instruction The Check Cartridge must be protected from sunlight during storage do not leave the check cartridge in direct sunlight for long periods of time Store the Check Cartridge at 2 32 C 36 90 F Store the Check Cartridge at a Humidity 90 Always store the Check Cartridge in its protective packaging to prevent scratchs that may affect the test result I...

Page 16: ...errer message is displayed repeat the test If is still displays Er 2 message Do Not use the analyzer Please contact your local representative for customer support CLOVER A1c Self 30 13 CHECKING THE SYSTEM 3 Insert the Daily check cartridge while Daily and CHECK are blinking 2 Press for 3 seconds to enter into the Daily check cartridge mode 1 Open the Cover of CLOVER A1c Self Analyzer How to use th...

Page 17: ... Monthly check cartridge Once a month before samples are tested When there is a concern that the test result may be incorrect After an error message Er 4 or Er 5 The Monthly check cartridge used to check the Analyzer is composed of a cartridge and a regent pack just like the test cartridge but without the capillary rod NOTE If Monthly Check Cartridge be reused analyzer show up Do not reuse The Mon...

Page 18: ...o Not use the analyzer Please contact your local representative for customer support 08 03 30 HbA1c AM10 09 Glucose Remove CLOVER A1c Self 34 13 CHECKING THE SYSTEM NOTE Do not contaminate sample collecting area Capillary tip of reagent pack CAUTION 5 Insert the Monthly Check Reagent Pack when the insert check reagent pack icon is displayed Insert it respectively 4 Gently mix the reagent pack 5 6 ...

Page 19: ...adequate inadequate CLOVER A1c Self 36 13 CHECKING THE SYSTEM 2 Insert the cartridge when the Cartridge insert icon displayed HbA1c Control Solution If external quality control testing is desired commercial controls from other vendors may be purchased Controls of human whole blood only can be used with the CLOVER A1c Self Please contact your local representative for technical support When to run a...

Page 20: ...Please contact your local representative for customer support 7 After the test is complete Take out the cartridge NOTE If an error message is displayed repeat the check again If it still displays error message Do Not use the analyzer CLOVER A1c Self 38 13 CHECKING THE SYSTEM 4 Insert the reagent pack into the cartridge and close the cover to the analyzer 5 Close the cover The test starts automatic...

Page 21: ...40 14 OPTIONS The CLOVER A1c Self can test the blood glucose by simply connecting the glucose module STEP 1 Prepare the test item for measuring glucose level using the module 3Sec glucose module 5Sec glucose module or STEP 2 Connect the blood glucose Module to the port located in the front side of the Analyzer 14 1 Blood Glucose Test CAUTION 1 Yellow Glucose Module is for 3 Seconds product and the...

Page 22: ...e refer to page 15 Automatic Prints automatically after every test Manual Prints only when printer button pressed On Off 9V USB Código de barras Impressora Current Only that result will print ALL Every result in memory will print CLOVER A1c Self 42 14 OPTIONS STEP 7 The analyzer will display the blood glucose test result STEP 8 Once the test is complete slide the ejector button forward to remove t...

Page 23: ...ead It can be very hot after printing continuously for a long time Make sure that the paper direction is correct CLOVER A1c Self 44 14 OPTIONS Unpacking The below pictures show the items which should be included for the standard of SRP III Package If any items are damaged or missing please contact with our local representatives for technical assistance Interface cable RS 232C AC DC adaptor 9V 2A S...

Page 24: ... 2 Insert the cartridge when the Cartridge insert icon is displayed STEP 3 The LCD display will prompt you to scan carcode On Off 9V USB Barcode Printer CLOVER A1c Self 46 14 OPTIONS Specification 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 ...

Page 25: ...played on the LCD If the reader is not able to consistently read your labels apply a test label of the format being used to a new specimen tube and perform the barcode test If the reader is able to read the test label the quality of your labels may be inadequate If the test label cannot be read the reader itself could be the problem Contact with our local representatives for technical assistance N...

Page 26: ...code label reagent pack surface of cartridge etc or alien substance was inserted into the check cartridge Er 5 Problem with reagent pack of the test cartridge The analyzer is unable to recognize 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 again CLOVER A1...

Page 27: ...lower than 4 0 20mmol mol CLOVER A1c Self 52 16 TROUBLESHOOTING ERROR CODE CORRECTIVE ACTION DESCRIPTION Er 8 Er 9 Please re connect the cable again If problem persist contact your local representative Please insert a new test strip and perform the test agaim If the problem paersists open a new bottle and repeat test Damaged glucose test strip Problem with the glucose module connection Please pres...

Page 28: ...lood sample The HbA1c test result is higher than 14 0 130mmol mol Please double check the accuracy of the test strip by performing a control solution test and re test with blood sample The blood glucose test result is lower than 10mg dl or 0 6mmol L ERROR CODE CORRECTIVE ACTION DESCRIPTION CLOVER A1c Self 55 17 SPECIFICATION Storage Temperature 10 35 50 95 Option Glucose Test Module PC Connection ...

Page 29: ...the air filter 3 Cleaning the cartridge compartment 1 Disconnect the analyzer before cleaning 2 Dust the Analyzer by wiping with a soft clean cloth 3 Do not use liquid or aerosol cleaners 4 If necessary alcohol swab can be used to wipe out dirt but other chemical solutions should not be used Cleaning solutions may cause damage to the analyzer surface STEP 1 Turn the power off and disconnect the po...

Page 30: ...Regulations EN 61010 1 SAFETY TIPS 1 Do not disassemble the Analyzer 2 Do not place the analyzer in places with high humidity 3 Do not place the analyzer in polluted or dusted areas 4 Do not expose the analyzer to any impact shock or vibration 5 Do not place the analyzer next to any chemical products 6 Keep away from direct sun light 7 Do not cover the ventilation openings on the back with any mat...

Page 31: ...e operating Bead Window Absorption Pad CLOVER A1c Self 60 21 PRECAUTION 8 Cartridge should be kept at the same test environment beside the Analyzer at least 30 minutes before test 9 While collecting blood users should contact the end of capillary tip slightly to the blood sample not putting the tip deep into the blood sample Putting the capillary tip deep into the blood sample may cause high resul...

Page 32: ...ent Symbol Description This symbol indicates a temperature hazard This symbol indicates the position of inserting the reagent pack CLOVER A1c Self 62 22 SYMBOL DESCRIPTION This symbol indicates that the product complies with the applicable directives of the European Union Consult instruction for use In vitro diagnostic medical device Catalog number Used by Batch code Authorised representative in t...

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