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iHealth BG1 Owner's Manual

Align gluco-monitoring system
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Align Gluco-Monitoring System (BG1)
OWNER'S MANUAL
For in vitro diagnostic use only
Read instructions before use for self-testing

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Summary of Contents for iHealth BG1

  • Page 1 Align Gluco-Monitoring System (BG1) OWNER’S MANUAL For in vitro diagnostic use only Read instructions before use for self-testing...

  • Page 2: Table Of Contents

    TEST PRINCIPLE IMPORTANT TEST INFORMATION GET STARTED USING PHONE SANITARY COVER REFERENCE VALUE OF THE iHealth Align GLUCO-MONITORING SYSTEM THE IHEALTH SYSTEM CARE AND MAINTENANCE PERFORMING A BLOOD GLUCOSE TEST WITH ALTERANTE SITE IMPORTANT INFORMATION ABOUT CONTROL SOLUTION TESTS COMPARING GLUCOSE METER TEST RESULTS WITH LABORATORY RESULTS...

  • Page 3: Introduction

    • Self-testing outside the body (in vitro diagnostic use) as an aid to monitor the effectiveness of diabetes control. The iHealth system should not be used for the diagnosis of or screening for diabetes, or for neonatal use. • Alternative Site Testing (AST) should be performed only during steady state times when glucose levels are not changing rapidly.

  • Page 4: Contents Of The Ihealth Align Gluco-Monitoring System

    • Do not use the iHealth system if it has sustained any damage or is not working properly. • Keep the iHealth system away from heat at all times. Do not let the iHealth system come into contact with surfaces that are hot to the touch.
  • Page 5 Absorbent hole Confirmation window Test strip handle Contact bars Test Strip Port • The Meter • The Test Strip ( AGS1000I ) • iHealth Control Solution (Level II) Lancet Cap Cocking Handle • Lancet Release Button Lancet Removal Handle Depth Indicator Window White Cap (for finger testing)

  • Page 6: Test Principle

    3. The number of sanitary covers for the mobile device is equal to the number of test strips. 4. Only iHealth Level II control solution is included in the package. If you need level I and level III control solution, please call iHealth Labs Customer Service at: 1‐855‐816‐7705 for assistance.

  • Page 7: Get Started

    Connect your mobile device to the Internet and open the Gluco-Smart App. When prompted, scan the QR code on the top of the iHealth test strip vial to calibrate the test strips with the meter. You must scan the QR code each time a new vial is opened.
  • Page 8 Step 3: Insert the test strip into the meter’s strip port Make sure the red arrow marker on the test strip is facing the same direction as the iHealth logo on the meter. Step 4: Prepare the lancing device Snap off the lancing device cap Œ...
  • Page 9 Step 6: Apply the blood sample to the test strip Quickly apply the blood sample to the absorbent hole on the tip of the test strip. Make sure the confirmation window of the test strip is completely filled with the blood sample, and remove your finger.

  • Page 10: Using Phone Sanitary Cover

    USING PHONE SANITARY COVER We strongly advise that you put your mobile device into the sanitary cover before testing. The sanitary cover is for single testing use only. Please contact iHealth customer service for purchasing additional sanitary covers. REFERENCE VALUE OF THE iHealth Align GLUCO-MONITORING...

  • Page 11: The Ihealth System Care And Maintenance

    Follow the instructions below to replace the battery. 1. Turn the meter over with the iHealth logo facing down. 2. Lift off the back cover by pulling firmly from the notch next to the test strip port.
  • Page 12 Signs of Potential Physical And Performance Deterioration If you encounter any of the following circumstances, stop using the meter and contact the place of purchase for assistance, or call the iHealth toll free customer service number at 1-855-816-7705: 1. The device does not work; for example, the mobile device does not begin testing when the meter is connected with the mobile device and when a test strip is inserted into the meter.

  • Page 13: Performing A Blood Glucose Test With Alterante Site

    You have the option of taking a blood sample from other sites on your body besides the fingertip. The iHealth system allows you to test on your palm, forearm, upper arm, calf, or thigh with equivalent results to fingertip testing when used appropriately. Remember to replace the lancing device cap with the clear cap and follow the above “Test blood glucose level”...

  • Page 14: Important Information About Control Solution Tests

    Materials needed to perform a control solution test: • iHealth Align Gluco-Monitoring System (BG1) • iHealth Blood Glucose Test Strip AGS1000I • iHealth Control Solution (Level I, Level II, or Level III) Perform a control solution test when: • First receiving or purchasing the meter.

  • Page 15: Comparing Glucose Meter Test Results With Laboratory Results

    The iHealth system provides you with whole blood equivalent results. The result you obtain from your glucose meter may differ somewhat from your laboratory results due to normal variation. The iHealth system results can be affected by factors and conditions that do not affect laboratory results in the same way.

  • Page 16: Test Strip Vial Label

    TEST STRIP VIAL LABEL iHealth Align GLUCO-MONITORING SYSTEM SPECIFICATIONS 1. Model: BG1 2. Machine size: 2.03’’× 1.17’’× 0.37’’ (52mm × 30mm × 9.5mm) 3. Measuring method: Amperometric technology using glucose oxidase 4. Result range: 20 mg/dL - 600 mg/dL (1.1 mmol/L - 33.3 mmol/L) 5.

  • Page 17: Limitations Of Use

    • The iHealth Align Gluco-Monitoring System should only be used with iHealth test strips (AGS1000I). • The iHealth Align Gluco-Monitoring System can be used up to an altitude of 10,744 feet (3,276 meters). • The following substances at levels greater than normal or therapeutic levels may cause significant interference (affect the result by greater than 10%), resulting in an inaccurate result: ascorbic acid, uric acid, acetaminophen, dopamine, L-dopa.

  • Page 18: System Troubleshooting

    • The meter will automatically adjust for the current time zone when the testing takes place. When traveling across time zones, living on or near a time zone boundary, you need to be aware that the logged glucose measurement times may not be synchronized to your normal day-to-day regime.

  • Page 19: Warranty Information

    ("Warranty Period"). Under this Limited Warranty, if a defect arises and a valid claim is received by iHealth within the Warranty Period regarding the Product, at its option and to the extent permitted by law, iHealth will either (1) repair the Product using new or refurbished replacement parts or (2) exchange the Product with a new or refurbished Product.

  • Page 20: Explanation Of Symbols

    EXPLANATION OF SYMBOLS In vitro diagnostic medical device Serial number Caution, consult accompanying documents Consult instructions for use Manufacturer Electrical products waste should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice. Authorized representative in the European Community THIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES Keep away from rain...

  • Page 21: Important Information Required By The Fcc

    IMPORTANT INFORMATION REQUIRED BY THE FCC Changes or modifications not expressly approved by iHealth Lab Inc. would void the user’s authority to operate the product. NOTE: This product has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.

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