Infopia ELEMENT MULTI Instructions For Use Manual
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Infopia ELEMENT MULTI Instructions For Use Manual

Glucose & cholesterol measuring system
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2012-05-01

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Summary of Contents for Infopia ELEMENT MULTI

  • Page 1 2012-05-01...
  • Page 2 Dear Element Multi glucose and cholesterol measur- ing system Owner Thank you for choosing Element Multi glucose and cholesterol measur- ing system. This instruction for use includes important information you need to know about Element Multi glucose and cholesterol measuring system.

  • Page 3: Test Principle

    How to use Instructions For Use Element Multi glucose and cholesterol measuring system has two kinds of test This guide includes all the information you need to use Element Multi for self- principle according to test items: one for blood glucose and the others for testing.

  • Page 4: Table Of Contents

    6. Deleting your Results ------------------------------------------------------44 7. Element Multi Software and Thermal Printer-----------------------45 Element Multi system has been sealed to protect the contents. 8. Cleaning Your Meter and Maintenance----------------------------------46 If you find your seal broken, please return it to the place of purchase.

  • Page 5: Element Multi Testing Meter

    Average Test Results(only for glucose) Control Solution Symbol Caution 1. Do not use Element Multi meter in a dry environment, especially if synthetic Day & Month materials are present. Synthetic clothes, carpets, etc., may cause damaging static discharges in a dry environment.

  • Page 6: Element Multi Test Strip Information

    Part to grab meter for glucose measuring test. Caution 1. Store the Element Multi test strip vials in a cool and dry place. Keep out of direct 1. Profile test strip sunlight. Do not freeze. 2. Store test strips in their original vial only. Do not mix the test strips in new vials or in...
  • Page 7 (Please refer to strip instructions for use for more details). - Precision Results for Control Solutions. Testing Range: The test range of Element Multi is 100 ~ 400 mg/dL (2.59-10.36mmol/L) for total cholesterol, 25~80mg/dL (0.65-2.08mmol/L) for HDL-cholesterol and 2-1.
  • Page 8 Accuracy: Element Multi Test Strip Information The accuracy results obtained with the Element Multi glucose and cholesterol measuring system were compared to glucose results obtained with the Hitachi LIMITATIONS OF SYSTEM for glucose test meter 747, a laboratory instrument. Glucose levels were measured on 160 patients at three different clinical centers.

  • Page 9: Setting Your Meter

    Setting Mode The Element Multi requires two(2) AAA 1.5 volt alkaline batteries. It is recommended to set your Element Multi meter properly before using. When to replace the batteries: The meter will give you an indication on the display that the batteries need to be The meter enters setting mode with a beep sound changed.

  • Page 10: Checking The System With Control Solution

    ). If you select ‘ON’ and press Mode( Note: button to active it. If you select print, this setting mode is The Element Multi Control Solutions are sold separately. completed. The TC(Level 1, Level 2), TG(Level 1, Level 2) and HDL (Level 1, Level 2) control solutions can be obtained.
  • Page 11 Checking the system with control solution Checking the system with control solution Caution 3. Check the code number on the display of the meter with that on the strip vial. Please check the expiry date on the instructions for use provided with each control solution.
  • Page 12 • After following the appropriate steps and the control solution tset result is out of range, do not perform a test. Please contact the infopia customer service at +82-31-460-0300 or sales@infopia21.com. 5. Apply the test strip to the control solution.

  • Page 13: Checking The System With Lipidprofile Check Strip

    Before first use. contamination. When the test rusults of Element Multi are higher or lower than your symtoms. • If the lancing device is to be used by another person, the unit must be properly disinfected and a new tip and lancet must be used.
  • Page 14 HOW TO USE 6. Hold the tip firmly in one hand then pull out the Wash your hands carefully with warm water to increase the circulation of the sliding barrel with the other hand. This will cock the blood into the fingers. lancing device.

  • Page 15: Testing Your Blood

    - Take out a drop of blood sample on a clean container. - Apply your blood sample to the Element Multi Profile strip and do not take off capillary rod until you get the beep sound. The test will automatically start.

  • Page 16: Testing Your Blood

    Test Procedure Testing Your Blood Capillary blood process 1. Test for profile strips Caution You may get an inaccurate result if the blood sample is not completely fill in a single Insert a profile test strip and press mode action. )button.
  • Page 17 Test Procedure Test Procedure 2. Test for each single item 1) Total Cholesterol test Please apply the sample to the HDL-cholestrol test area of test strip until you hear beep sound. Then, the symbol, disappears. Insert a total cholesterol test strip and press mode ( )button.
  • Page 18 Test Procedure Test Procedure The meter displays , blinking in order, The symbol of blood is blinking. which means it is currently undergoing tests. When the test is completed (in 2 minutes), the meter displays the test result of with the symbol.
  • Page 19 Test Procedure Test Procedure 3) Triglyceride test Insert a triglyceride test strip and press mode The meter displays , blinking in ) button. order, which means it is under test. Place the RFID-tag on the strip bottle to the area of the RFID symbol ( ) on the meter.

  • Page 20: Test Procedure

    3.Test for glucose Firmly insert the glucose test glucose test strip into the test port of Element Multi meter and then the power will automatically turn on with the code number, temperature and time. Make sure code number on display of the meter correspond with that on the tset strip vial.

  • Page 21: Alternate Site Testing At Glucose Measuring

    Alternate site testing at glucose measuring Performing a Blood Test using an Alternate site Note : This alternate site testing is applied to glucose testing only. Important : We recommend that you test on your fingertip if you are testing for hypogly- cemia (low blood glucose) or if you have a history of reoccurring hypoglyce- mia.

  • Page 22: Reviewing Your Results

    Reviewing Your Results Reviewing Your Results Every test result is stored with its date and time of test. Profile test results The meter stores 200 memories regardless of test items. Press Mode ( ) button. When the test results is over the capacity memory, the recent test result will replace with the oldest test result.

  • Page 23: Deleting Your Results

    Element Multi Software and Thermal Printer Deleting individual test result The Element Multi results can be transmitted to a personal computer. Element Multi software and an interface cable are required for transmit- To delete any individual test result in the memory press ting results of Element Multi profile and glucose measurement system ▲...

  • Page 24: Cleaning Your Meter And Maintenance

    A cloth dampened with water and mild detergent can be used to wipe down the Oxidization voltage is out of range, etc. outside of the meter.Your Element Multi meter is a precision instrument. Please handle it with care. This message appears Please insert a new test strip 1) Do not disassemble or modify the meter.

  • Page 25: Troubleshooting

    Troubleshooting Troubleshooting Message Probable cause Action required Message Probable cause Action required The test result is lower Please retest with a new test strip. This message appears Please wait for the meter displays the than the following. If the problem persists, please contact when blood sample is icon blinking before applying your blood Glucose : less than...

  • Page 26: Product Specifications

    If you experience symptoms that are not consistent with your glucose and Testing Types Glucose cholesterol results, Please make sure you have followed all instructions in this instructions for use. Then, contact infopia Customer Service. Never ignore symptoms or make significant changes to the control program. Test range 10~600 mg/dL Product Specification 0.3 ㎕...

  • Page 27: Warranty

    This warranty is subject to the following exceptions and limitations: Operation humidity 10 ~ 90% 1. infopia Co., Ltd. shall not be required to replace any unit which are damaged or malfunction due to abuse, accidents, alteration, neglect, misuse, mainte- Display type nance by someone other than infopia Co., Ltd., or failure to operate in...

  • Page 28: Symbol Reference

    Symbol Reference Symbol Description Serial number Consult operating instructions Used By This product fulfills the requirements of Directive 98/79/EC on in vitro diagnostic medical devices Caution, consult accompanying documents For In Vitro Diagnostic Use Batch code Catalogue Number Temperature limitation Do not re-use Date of Manufacture Keep away from sunlight...

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