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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

    IMPORTANT TEST INFORMATION INSTALL THE BATTERY 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 ALTERNATE SITE IMPORTANT INFORMATION ABOUT CONTROL 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: Important Safety Instructions

    • 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 Connector Absorbent hole Confirmation window Test strip handle Contact bars Test Strip Port • iHealth Control Solution (Level II) • The Meter • The Test Strip ( AGS-1000I ) Lancet Cap Cocking Handle • Lancet Release Button Lancet Removal Handle...

  • 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: Install The Battery

    • Do not use test strips that are expired or appear to be damaged as they may return inaccurate results. • Always use care when handling the iHealth Align Glucose Meter. Dropping or throwing the meter may cause damage. • Don't expose the iHealth Align Glucose Meter, test strips, or control solution to extreme conditions such as high humidity, heat, freezing cold, or dust.

  • Page 8: Get Started

    Please carefully read and follow the instructions below to avoid getting inaccurate readings: 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 ONLY when a new vial is opened for the first time.
  • Page 9 Step 5: Prepare the lancing device Snap off the lancing device cap Œ Insert a new lancet firmly into the lancing device holder cup  Twist the lancet cover off Ž Replace the lancing device cap  Set the lancing level to your desired pressure level ...
  • Page 10 Step 7: 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 11: Using Phone Sanitary Cover

    THE IHEALTH SYSTEM CARE AND MAINTENANCE • Always use care when handling the iHealth Align Glucose Meter. Dropping or throwing the meter may cause damage. • Don't expose the iHealth Align Glucose Meter, test strips, or control solution to extreme...
  • Page 12 Do not insert the CaviWipe into the test port. 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:...

  • Page 13: Performing A Blood Glucose Test With Alternate 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（AGS-1000I） • iHealth Control Solution (Level I, Level II, or Level III) Perform a control solution test when: • First receiving or purchasing the meter.
  • Page 15 • Meter malfunction. If you continue to get control solution test results that fall outside of the range printed on the vial, the meter may not be working properly. Discontinue use and call iHealth Labs Customer Service at 1-855-816-7705 for assistance.

  • Page 16: 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 17: Limitations Of Use

    • The iHealth Align Gluco-Monitoring System should only be used with iHealth test strips (AGS-1000I). • 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

    iHealthLabs Europe SARL www.ihealthlabs.eu 3 Rue Tronchet, 75008, Paris, France +33(0)1 44 94 04 81 (9:00 AM-5:30 PM, Monday to Friday except holidays) Email: support@ihealthlabs.eu ANDON HEALTH CO., LTD. No. 3 Jin Ping Street, Ya An Road, Nankai District, Tianjin 300190, China Tfno.: +86-22-60526161 EXPLANATION OF SYMBOLS In vitro diagnostic medical device...

  • Page 21: Important Information Required By The Fcc

    Complies with IVD98/79/EC requirements 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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