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Summary of Contents for iHealth Gluco-Monitoring System
- Page 1 Wireless Smart Gluco-Monitoring System OWNER’S MANUAL...
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Page 2: Table Of Contents
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 INTENDED USE IMPORTANT SAFETY INSTRUCTIONS CONTENTS OF THE WIRELESS SMART GLUCO- MONITORING SYSTEM Parts and Displays... - Page 3 LABORATORY RESULTS Before the Lab Test While at the Lab TEST STRIP VIAL LABEL IHEALTH WIRELESS SMART GLUCO MONITORING SYSTEM SPECIFICATIONS MAINTENANCE AND STORAGE OF YOUR IHEALTH SYSTEM LIMITATIONS OF USE SYSTEM TROUBLESHOOTING DISPLAY MESSAGES TROUBLESHOOTING INTERNATIONAL BLOOD GLUCOSE MEASUREMENT UNITS...
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Page 4: Introduction
Self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the e ectiveness of diabetes control The iHealth system should not be used for the diagnosis of or screening for diabetes, or for neonatal use. IMPORTANT SAFETY INSTRUCTIONS Please read the following information carefully before using the iHealth system. -
Page 5: Parts And Displays
• 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 Appears when the battery is low. 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:...
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Page 7: Mobile Device Compatibility
Absorbent hole Confirmation window Test strip handle Contact bars • iHealth Test Strip Head Main body Remove lancet part Release button Cap (for finger testing) • Clear Cap for Alternate Site Testing • • Lancet iHealth Control Solution Lancet cover... -
Page 8: Test Principle
2 or later iPod touch (4th generation) or later 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 9: Important Test Information
FIRST TIME SETUP INSTRUCTIONS • Download the companion app Prior to rst use, download and install the free iHealth Gluco- Smart App from the App Store to your iOS device. Follow the on-screen instructions to create your iHealth ID. - Page 10 • 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”. • Charge the battery Out of the box Your meter is powered by a built-in, rechargeable battery. Plug one end of the charging cable into the side of the meter and the other end into your computer’s USB port.
- Page 11 2. Press and hold the “Memory” button for three seconds to turn the meter on. Memory button First press "Scan" or "Search" to nd the meter if you are on Android devices.) Select the model name “BG5xxxxxx” in the Bluetooth menu to pair and connect. AT&T 7:28 AM Settings...
- Page 12 Your mobile device must stay connected to the internet. [2] Scan the QR code Scan the QR code on 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 rst time.
- Page 13 w Twist the lancet cover o x Replace the lancing device cap y Set the lancing level z Cock the handle until it clicks [5] Obtain a blood sample. Press the lancing device against the site to be lanced. Press the release button to puncture the site.
- Page 14 Quickly remove your nger from the test strip when the countdown (from 5 to 1) begins on the meter display, or when you hear a sound alert from your mobile device. [7] 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.
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Page 15: Data Syncing
NOTE: The results obtained from the glucose meter are plasma- calibrated. This helps you and your physician or other quali ed healthcare providers to compare your meter results with laboratory tests. Refer to the instructions given by your physician or other quali ed healthcare providers.Do not deviate from these instructions on the basis of the result without rst consulting your physician. -
Page 16: Cleaning And Disinfection
When you reach the last test result, the word “End” will appear, and the meter will shut o automatically. Similarly, the meter will shut o automatically when it is idle for three minutes. CLEANING AND DISINFECTION Cleaning and disinfection is a necessary and important part of the test procedure. -
Page 17: Signs Of Potential Physical And Performance Deterioration
1. After a test, clean and wash your hands. 2. Use one CaviWipe to carefully clean the meter, front and back. 3. Then, disinfect the meter with another wipe and allow the surface to dry naturally: this should take approximately 2 minutes. -
Page 18: Information About Alternate Site Testing (Ast)
Finger Alternate Site Testing (AST) is the use of parts of the body, other than the ngertips, 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 ngertip testing when used at... -
Page 19: What Is The Advantage Of Alternate Site Testing
AST. 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. -
Page 20: Important Information About Control Solution Tests
• The meter has been dropped or damaged PERFORMING A CONTROL SOLUTION TEST [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. - Page 21 The result of the control solution test should be within the range printed on the test strip vial label. If the test result falls outside the speci ed range, repeat the test, carefully following the steps above. [2] When the meter is connected to your iHealth Gluco-Smart...
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Page 22: Out-Of-Range Results
The result you obtain from your glucose meter may di er somewhat from your laboratory results due to normal variation. The iHealth system results can be a ected by factors and conditions that do not a ect laboratory results in the same way. -
Page 23: Before The Lab Test
If possible, fast at least eight hours before conducting a comparison test. • Take the iHealth system to the lab. While at the Lab Make sure that samples for both tests are taken and tested within 15 minutes of each other. -
Page 24: Maintenance And Storage Of Your Ihealth System
2000mg/dL Hemoglobin 250mg/dL MAINTENANCE AND STORAGE OF YOUR IHEALTH SYSTEM • Always use care when handling the iHealth Smart Glucose Meter. Dropping or throwing the meter may cause damage. • Don't expose the iHealth Smart Glucose Meter, test strips, or... -
Page 25: Limitations Of Use
• 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... -
Page 26: System Troubleshooting
If you follow the recommended action but the problem persists, or error messages other than the ones below appear, please call iHealth Labs Customer Service at 1-855-816-7705. Do not attempt to repair the meter by yourself and never try to disassemble the meter under any circumstances. - Page 27 The environmental The operating temperature is temperature is lower than 50°F 104°F (10°C 40°C). 50°F(10°C The environmental The operating temperature is temperature is higher than 50°F 104°F (10° C 40° C). 104°F(40°C). Communication error. Touch START to re-test. Strip removed during Start again using a new test strip.
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Page 28: Troubleshooting
4. iHealth system is not 4. Bring the iHealth system to performing due to the a room-temperature environment being above or environment and wait below room temperature. -
Page 29: International Blood Glucose Measurement Units
INTERNATIONAL BLOOD GLUCOSE MEASUREMENT UNITS Unit of Measure Unit of Measure Country Country Used Used Algeria mg/dL Australia mmol/L Argentina mg/dL Canada mmol/L Austria mg/dL China mmol/L Bahrain mg/dL Czech Republic mmol/L Bangladesh mg/dL Denmark mmol/L Belgium mg/dL Finland mmol/L Brazil mg/dL Germany... -
Page 30: Warranty Information
WARRANTY INFORMATION iHealth Lab, Inc. ("IHealth") warrants the iHealth meter (the "Product"), and only the Product, against defects in materials and workmanship under normal use for a period of three years from the date of purchase by the original purchaser ("Warranty... - Page 31 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.
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Page 32: Explanation Of Symbols
ANDON HEALTH CO., LTD. No. 3 Jin Ping Street, Ya An Road, Nankai District, Tianjin 300190, China Tel: +86-22-60526161 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. -
Page 33: Important Information Required By The Fcc
Changes or modi cations 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 34 NOTICE: Changes or modi cations 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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