iHealth BG5 Owner's Manual
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iHealth BG5 Owner's Manual

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  • Page 1 Wireless Smart Gluco-Monitoring System...

  • Page 2: Table Of Contents

    OWNER’S MANUAL For in vitro diagnostic use only Read instructions before use for self-testing iHealth Wireless Smart Gluco-Monitoring System ® OWNER’S MANUAL Table of Contents INTRODUCTION 1 INTENDED USE 1 IMPORTANT SAFETY INSTRUCTIONS CONTENTS OF THE WIRELESS SMART GLUCO- MONITORING SYSTEM...
  • Page 3 When Should You Use Alternate Site Testing? IMPORTANT INFORMATION ABOUT CONTROL SOLUTION TESTS17 PERFORMING A CONTROL SOLUTION TEST Out-of-Range Results COMPARING GLUCOSE METER TEST RESULTS WITH LABORATORY RESULTS While at the Lab TEST STRIP VIAL LABEL SPECIFICATIONS LIMITATIONS OF USE SYSTEM TROUBLESHOOTING DISPLAY MESSAGES TROUBLESHOOTING...

  • Page 4: Introduction

    Self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control The iHealth system should not be used for the diagnosis of diabetes or screening for diabetes, or for neonatal use. IMPORTANT SAFETY INSTRUCTIONS Please read the following information carefully before using the iHealth system.
  • Page 5 Owner’s Manual. • Use only accessories that are supplied by the manufacturer. • 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 6: Contents Of The Wireless Smart Gluco- Monitoring System

    CONTENTS OF THE WIRELESS SMART GLUCO- MONITORING SYSTEM Package contents vary from country to country. Please refer to the package contents listed on the package you purchased. • iHealth Smart Glucose Meter • Clear Cap for Alternate (the meter) Site Testing • iHealth Test Strip •...

  • Page 7: Parts And Displays

    • Quick Start Guide Note: If any items printed on the package are missing from your package or the package appears to have been opened prior to your use, please call iHealth Labs Customer Service at 1-855- 8167705. Parts and Displays iHealth Blood Glucose Meter(the meter) •...
  • Page 8 LOW BATTERY SYMBOL MEASUREMENT UNIT Appears with the test result either in mg/dL or mmol/L. • iHealth Test Strip Use only iHealth test strips with the meter. Each test strip can be used only once, and consists of the following parts:...

  • Page 9: Mobile Device Compatibility

    Absorbent hole Confirmation window Test strip handle Contact bars Head Main body Remove lancet part Release button Cap (for finger testing) • • Lancet iHealth Control Solution Lancet cover Mobile Device Compatibility...

  • Page 10: Test Principle

    (5th generation) iPod touch (4th generation) TEST PRINCIPLE Testing with the iHealth system is based on the measurement of electrical currents generated by the reaction of glucose with the reagent of the test strip. The iHealth system measures the current and converts it to the corresponding blood glucose level.
  • Page 11 Critically ill patients should not be tested with blood glucose meters. • If your blood glucose results are lower or higher than usual, and you do not have symptoms of illness, first repeat the test. If you have symptoms or continue to get results that are higher or lower than usual, follow the treatment advice of your healthcare professional.

  • Page 12: First Time Setup Instructions

    GlucoSmart App from the App Store to your iOS device. Follow the on-screen instructions to create your iHealth ID. • Access iHealth Cloud You can use your iHealth ID to gain access to free and secure Cloud Services. Go to www.ihealthlabs.com and click on “Sign In”. •...

  • Page 13: Sync Meter

    power. You must recharge the battery before using it again. After three seconds, the meter shuts off automatically. The meter does not take any measurement when the battery is low. Important: If battery is completely drained, fully charge the battery and launch the app to sync the meter before using it again.
  • Page 14 turn the meter on. to...
  • Page 15 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 16 • Test blood glucose level If you have synced your meter to the app on your iOS device, scanned the QR code of a test strip vial, and want to take a reading with the app: [1] Turn the Bluetooth on to connect the meter to the app on your iOS device.
  • Page 17 [4] Obtain a blood sample. Press the lancing device against the site to be lanced. Press the release button to puncture the site. Gently squeeze your finger until a drop of blood forms. Wipe away the first blood drop and squeeze until a second small blood drops forms.
  • Page 18 [6] Read the test results. -If the meter is not connected to the app, the test result will appear on the meter after counting down from 5 to 1. appear on the app.

  • Page 19: Data Syncing12

    [7] Discard the used test strip and lancet.Remove the used test strip from the meter using a small amount of tissue paper. Discard the used test strip and lancet properly. (Tip: Prior to disposal, stick the lancet into the cover.) DATA SYNCING The meter can save up to 500 of the most recent blood glucose test results.

  • Page 20: Cleaning And Disinfection

    CLEANING AND DISINFECTION Cleaning and disinfection is a necessary and important part of the test procedure. It can help to prevent infection, the potential spread of infection, and cross-contamination. Cleaning can also ensure that the meter works properly and that the display is clear and readable.

  • Page 21: Signs Of Potential Physical And Performance

    3. Then, disinfect the meter with another wipe and allow the surface to dry naturally: this should take approximately 2 minutes. 4. Use the same method with the CaviWipes to clean and disinfect the lancing device. Note:  Each disinfection step requires a pre-cleaning step. Wash hands thoroughly with soap and water after handling the meter, lancing device, or test strips.

  • Page 22: Information About Alternate Site Testing (Ast)

    Finger Alternate Site Testing (AST) is the use of parts of the body, other than the fingertips, to check blood glucose levels. The iHealth system allows you to test on the palm, forearm, upper arm, calf, or thigh with equivalent results to fingertip testing when used at appropriate times.

  • Page 23: What Is The Advantage Of Alternate Site Testing

    There are limitations for doing AST. Please consult your healthcare professional before you conduct AST. The iHealth system should only be used for AST under steady-state blood glucose conditions. What is the Advantage of Alternate Site Testing? Pain is felt more readily on the fingertips because they are full of nerve endings (receptors).
  • Page 24 • iHealth Blood Glucose Meter(the meter) • iHealth Test Strip • iHealth Control Solution Perform a control solution test when: • First receiving or purchasing the meter • Checking the meter and test strips (which should be done at least once a week) •...
  • Page 25 [1] When the meter is not connected to your iHealth Gluco-Smart App on your iOS device: Step 1: Turn on the control solution test (CTL) mode. Insert the test strip into the meter’s strip port to turn on the meter. When the blood sample symbol appears on the meter display, press the memory button to turn on the CTL mode.
  • Page 26 If the test result falls outside the specified range, repeat the test, carefully following the steps above. [2] When the meter is connected to your iHealth Gluco-Smart App on your iOS device: Step 1: Launch the app.
  • Page 27 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 28: System Specifications

    Never use your glucose meter with blood samples collected in a test tube. • Use fresh capillary blood only. IHEALTH WIRELESS SMART GLUCO-MONITORING SYSTEM SPECIFICATIONS 1. Model: BG5 2. Machine size: 3.8’’ × 1.35’’ × 0.75’’ (96 mm × 34.5 mm ×19 mm) 3.
  • Page 29 Compounds Limitation Ascorbic acid 2mg/dL Uric acid 10mg/dL Acetaminophen 5mg/dL Bilirubin 15mg/dL Dopamine 0.03mg/dL L-dopa 0.45mg/dL Methyldopa 0.75mg/dL Tolbutamide 24mg/dL Triglycerides 2000mg/dL Hemoglobin 250mg/dL MAINTENANCE AND STORAGE OF YOUR IHEALTH • SYSTEM Always use care when handling the iHealth Smart...
  • Page 30 • The iHealth system should only be used with iHealth test strips. • The iHealth system can be used up to an altitude of 3276 meters(10744 feet). • The following substances at levels greater than normal or therapeutic levels may cause significant interference (affect...

  • Page 31: System Troubleshooting

    If you do not know your hematocrit level, please consult your healthcare provider. We recommend periodic comparison of the iHealth system to another monitoring system known to be well maintained and monitored by a healthcare provider.
  • Page 32 The battery in your meter in Charge the battery. low on power. Problem with the meter. Re-test with a new test strip. If the problem persists, call iHealth Labs Customer Service at 1-855-816-7705 for assistance. Problems have occurred that Re-test using a new test strip.

  • Page 33: Troubleshooting

    Communication error. Touch START to re-test. Strip removed during Start again using a new test strip. measurement. Your meter is not synced to Follow the instructions above in the ‘FIRST TIME SETUP the app on your iOS device INSTRUCTIONS” to sync your yet.

  • Page 34: International Blood Glucose Measurement Units

    4. iHealth system is not 4. Bring the iHealth system to a performing due to the room-temperature environment being above or environment and wait below room temperature.
  • Page 35 Bangladesh mg/dL Denmark mmol/L Belgium mg/dL Finland mmol/L Brazil mg/dL Germany mmol/L Caribbean Countries mg/dL Hong Kong mmol/L Chile mg/dL Ireland mmol/L Colombia mg/dL Kazakhstan mmol/L Ecuador mg/dL Malaysia mmol/L Egypt mg/dL Malta mmol/L France mg/dL Netherlands mmol/L Georgia mg/dL New Zealand mmol/L Greece...
  • Page 36 Luxembourg mg/dL United Kingdom mmol/L Mexico mg/dL Vietnam mmol/L Oman mg/dL Peru mg/dL Philippines mg/dL Poland mg/dL Portugal mg/dL Saudi Arabia mg/dL Spain mg/dL Syria mg/dL Taiwan mg/dL Thailand mg/dL Tunisia mg/dL Turkey mg/dL...

  • Page 37: Warranty Information

    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 38 Touch, iPad, and iPhone are trademarks of Apple Inc., registered in the U.S. and other countries. Manufactured for iHealth Lab Inc. USA: iHealth Lab Inc. www.ihealthlabs.com Mountain View, CA 94043, USA 855-816-7705 (8:30 AM –...

  • Page 39: Explanation Of Symbols

    EXPLANATION OF SYMBOLS In vitro diagnostic medical device Serial number Consult instructions for use Consult instructions for use Manufacturer Environmental Protection–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.

  • Page 40: 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.
  • Page 41 NOTICE: Changes or modifications made to this equipment not expressly approved by iHealth Lab Inc. may void the FCC authorization to operate this equipment. This product complies with Industry Canada. IC: RSS-210 This product is approved in accordance to R&TTE directive...

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