OSANG Healthcare Infopia Clover A1c Instructions For Use Manual
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OSANG Healthcare Infopia Clover A1c Instructions For Use Manual

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Summary of Contents for OSANG Healthcare Infopia Clover A1c

  • Page 2: Table Of Contents

    TABLE OF CONTENTS 1. INTENDED USE 2. GENERAL INFORMATION 3. PRINCIPLES OF OPERATION 4. CLOVER A1c ® CONTENTS 5. STORAGE INSTRUCTIONS 6. DEVICE DESCRIPTION 7. LIST OF ICONS 8. INSTALLATION 9. OPERATION 11~12 13~15 10. SETTING THE ANALYZER 11. TESTING HbA1c 16~25 12.

  • Page 3: Intended Use

    1. INTENDED USE 3. Principles of Operation ® The CLOVER A1c analyzer is an IVD(In Vitro Diagnostic Device) device for measuring 3.1 Reflectance Spectrophotometry Hemoglobin A1c by the well established method of boronate affinity. It is able to analyze both capillary whole blood and venous blood. Anticoagulants may be used, such as The CLOVER A1c ®...

  • Page 4: Storage Instructions

    4. CLOVER A1c Contents 6. Device Description ® 6.1 Analyzer Upon receipt of the product, carefully inspect for any obvious physical damage.If any damage is evident to the CLOVER A1c Analyzer, please consult our authorizedrepre- ® sentative in your area. LCD Display Contents 1.

  • Page 5: List Of Icons

    7. LIST OF ICONS 7. LIST OF ICONS Icon Name Function Icon Name Function It is displayed on the analyzer LCD Close the lid Warming up Close the lid of the analyzer. Warming up once it is powered on. Remove the cartridge from the Remove cartridge Open the lid of the analyzer.

  • Page 6: Installation

    8. INSTALLATION 9. OPERATION 9.1 Power On Overview Connect the DC 9V adapter to the power port on the back side of the analyzer. This section provides detailed installation instructions for the CLOVER A1c ® You must follow the installation steps correctly to ensure proper installation, operation, On/off Barcode Printer...

  • Page 7: Setting The Analyzer

    10. SETTING THE ANALYZER 9. OPERATION Getting into set up mode 9.2 Warming up When the power is connected, the displays shows 'Warming up' until the device is ready In stand-by mode, press the button and hold for 3 for test. seconds.
  • Page 8 10. SETTING THE ANALYZER 10. SETTING THE ANALYZER HbA1c test result unit Printer use Select whether or not to use the printer by pressing Select the desired HbA1c test unit by pressing the or , then press or , then press Printer If 'Use' is selected, Printer mode option is displayed.

  • Page 9: Testing Hba1C

    11. TESTING HbA1c 11. TESTING HbA1c PROCEDURE STEP 2. Open the lid of the CLOVER A1c analyzer, when the analyzer is in 'Stand-by' ® ® mode, displaying the 'Open the lid' icon. The CLOVER A1c test can be performed on capillary blood sample or on venous whole blood collected using K EDTA, lithium heparin, sodium citrate or sodium fluoride/ oxalate as an anticoagulant.
  • Page 10 11. TESTING HbA1c 11. TESTING HbA1c STEP 5-1. STEP 4. Gently mix the reagent pack 5 ~ 6 times before applying blood sample. Gently insert the cartridge into the cartridge compartment when ‘Insert Test Cartridge’ is shown. Hold the cartridge with barcode facing left. Ensure a gentle snap is either heard or felt to confirm proper placement.
  • Page 11 11. TESTING HbA1c 11. TESTING HbA1c Sample Collection and Handling. - Venous Blood Process Venous whole blood collected in tubes with K EDTA, lithium heparin, sodium citrate Capillary whole blood obtained from a fingertip can be used for HbA1c test. or sodium fluoride/ oxalate as anticoagulants can be used.
  • Page 12 11. TESTING HbA1c 11. TESTING HbA1c STEP 6. STEP 8. Insert the reagent pack into the cartridge in the analyzer. The ‘close the lid’ icon will be The measuring time is 5 minutes and the test result will be displayed (in % or mmol/mol). displayed.
  • Page 13 11. TESTING HbA1c 11. TESTING HbA1c Expected values Code confirmation display after the test Expected values The American Diabetes Association’s (ADA’s) 2012 Clinical Practice Recommendation In the event of an error in the process of recongnizing the cartridge code, the for diabetes specifies a treatment goal of less than 7% HbA1c.* analyzer asks for the type and code of the cartridge.

  • Page 14: Reviewing Results

    12. REVIEWING RESULTS 12. REVIEWING RESULTS STEP 2. STEP 1. The test results will appear chronologically starting with the most recent date. In stand-by mode, press the button for 3 seconds for Press the buttons to scroll through. Press either the button to select 'memory', then press No.47 mmol/mol...

  • Page 15: Checking The System

    13. CHECKING THE SYSTEM 13. CHECKING THE SYSTEM QUALITY CONTROL 13.1 Daily Check Cartridge The CLOVER A1c Check Cartridge checks that the optical and operating systems of the ® analyzer. Type of Check Cartridges • CLOVER A1c Daily Check Cartridges ®...
  • Page 16 13. CHECKING THE SYSTEM 13. CHECKING THE SYSTEM 4) Close the lid. The test starts automatically. How to use the Daily Check Cartridge 1) Open the lid CLOVER A1c Analyzer ® 13/03/30 13/03/30 13/03/30 5) After 1 mimute ‘OK’ or error message will be displayed. 2) Press for 3 seconds to enter into the ‘Daily Check’...
  • Page 17 13. CHECKING THE SYSTEM 13. CHECKING THE SYSTEM How to use the Monthly Check Cartridge 13.2 Monthly Check Cartridge ® 1) Open the lid CLOVER A1c Analyzer [ Monthly Check Cartridge ] [ Monthly Check Reagent Pack ] 13/03/30 Reagent Rinsing Solution Solution...
  • Page 18 13. CHECKING THE SYSTEM 13. CHECKING THE SYSTEM 4) Gently mix the Check Reagent Pack before use. 7) After 5 minutes ‘OK’ or error message will be displayed. 13/03/30 CAUTION : Do not mix too vigorously, it may cause air bubbles. If bubbles are present wait until they disappear.
  • Page 19 13. CHECKING THE SYSTEM 13. CHECKING THE SYSTEM 13.3 HbA1c Control Solution 13/03/30 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 ®...

  • Page 20: Option

    13. CHECKING THE SYSTEM 14. OPTIONS 14.1 Printing Test Results with the Thermal Printer 5) Close the lid. The test starts automatically. Connect the thermal printer to the analyzer with the interface cable(RS-232C). The analyzer should be in stand-by mode. 13/03/30 13/03/30 Barcode...

  • Page 21: Option

    14. OPTIONS 14. OPTIONS 14.2 Using Barcode Scanner Unpacking ® CLOVER A1c accepts data input from the following barcode symbologies The below pictures show the items which should be included for the standard of STP-103 Package. If any items are damaged or missing, please contact with our local Code 93 standard includes check digit representatives for technical assistance.
  • Page 22 - If this is not already installed on your computer, you can download it free at (http://www.adobe.com/products/acrobat/readstep2.html) - You can purchase the computer communication cable separately from a local representative. Please use the exclusive USB cable provided by OSANG Healthcare...

  • Page 23: Troubleshooting

    15. TROUBLESHOOTING 15. TROUBLESHOOTING GENERAL INFORMATION ERROR CODE DESCRIPTION CORRECTIVE ACTION If an operational or system problem occurs, an error code may display on the system screen with an explanation of the problem. This section of the guide lists the various The cartridge is left errors and messages, along with a description and corrective actions.

  • Page 24: Specification

    15. TROUBLESHOOTING 16. SPECIFICATION ERROR CODE DESCRIPTION CORRECTIVE ACTION Capillary whole blood, S a m p l e T y p e Venous blood with anticoagulant The HbA1c test Please use the check cartridge to >14% result is higher than Sample Volume 4 uL validate the analyzer and re-test the...

  • Page 25: Maintenance

    17. MAINTENSNCE 17. MAINTENSNCE Recommended maintenance routine Replacing the Fan Fileter : Check the fan filters located on the backside of the analyzer regularly. Replace the 1) Cleaning the exterior fan filter if it is clogged by dust. Extra filters come with your system. 2) Changing the fan filter 3) Cleaning the cartridge compartment Cleaning the analyzer...

  • Page 26: Safety

    1) Do not disassemble the Analyzer. 2) Do not place the analyzer in places with high humidity. OSANG Healthcare Co., Ltd. as the manufacturer, has specific instructions for the 3) Do not place the analyzer in polluted or dusted areas.

  • Page 27: Precaution

    20. PRECAUTION 20. PRECAUTION 1. Analyzer should be located on the flat table. 9. When collecting blood, touch the end of the capillary tip (sampling area) to the blood sample, do not put the tip deep into the blood sample to avoid excess blood. 2.

  • Page 28: Symbol & Description

    20. PRECAUTION 21. SYMBOL & DESCRIPTION 13. . After test completion and removal of cartridge, inspect the cartridge for symptoms. Symbol Description If any of the following symptoms occur, repeat the test to confirm validity of the result. This prodect fulfills the requirements of Directive 98/79/EC on in vitro diagnostic medical devices Consult instructions for use.
  • Page 29 21. SYMBOL & DESCRIPTION Symbol Description Do not reuse Date of Manufacturer Keep away from sunlight Direct Current Waste Electrical and Electronic Equipment Biohazard...
  • Page 31 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 INFH02B Fax : +(32) 2.732.60.03 E-Mail : mail@obelis.net IMC01452 Rev.2017-11-02...

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