iHealth BG1S Owner'S Manual Download Page 23

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EXPLANATION OF SYMBOLS

Manufacturer

European Authorized Representative

In vitro diagnostic medical device

Serial number

Consult instructions for use

Do not use if the package damaged

Batch code

Catalogue number

Caution

Use by date

Storage temperature Limit

Keep away from direct sunlight or near heat sources

Keep in a dry place

Do not reuse

Sterilized using irradiation

Bluetooth sign

Complies with the requirements of the European IVD Directive

(98/79/EC)

This device complies with part 15 of the FCC Rules

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.

Rev.06/2020

REP

Summary of Contents for BG1S

Page 1: ...iHealth Wireless Smart Gluco Monitoring System BG1S OWNER S MANUAL For in vitro diagnostic use only Read instructions before use for self testing...

Page 2: ...9 About the online test 9 CLEANING AND DISINFECTION 12 INFORMATION ABOUT ALTERNATE SITE TESTING AST 14 What is Alternate Site Testing 14 What is the advantage of Alternate Site Testing 14 When should...

Page 3: ...at home as an aid to monitor the effectiveness of diabetes control The iHealth Wireless Smart Gluco Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal u...

Page 4: ...her bloodborne pathogens For over the counter use Important safety instructions Please read the following information carefully before using the iHealth Wireless Smart Gluco Monitoring System BG1S Alw...

Page 5: ...Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html YOUR NEW WIRELESS SMART GLUCOSE METER Con...

Page 6: ...m direct sunlight Test strips must be stored in their original vial only Do not transfer them to a new vial or another container Do not touch the test strips when your hands are wet Use each strip pro...

Page 7: ...5 iHealth Lancing Device Use only with the iHealth lancet Use only iHealth Control Solution Keep the control solution at a temperature between 2 C and 30 C 36 F 86 F and at a humidity rate of 10 to 85...

Page 8: ...rt Gluco Monitoring System BG1S The iHealth Control Solution contains a specific quantity of glucose concentrate which reacts with the test strips it s used to verify the accuracy of blood glucose tes...

Page 9: ...contact with the control solution Once the test strip confirmation window is completely filled the meter will start counting down then you can remove the test strip from the control solution sample No...

Page 10: ...lycemic hyperosmolar state with or without ketosis Critically ill patients should not be tested with iHealth Wireless Smart Gluco Monitoring System BG1S If your blood glucose results are lower or high...

Page 11: ...to perform a blood glucose test When you perform a blood glucose test your results will be synchronized automatically on your iHealth profile WARNING When you get a new meter and you want to finish a...

Page 12: ...he battery according to following instructions before using it again 1 Turn the meter over with the iHealth logo facing down 2 Insert the narrow end of the pry plate into the machine groove close to t...

Page 13: ...and BG1S is nearby Step 4 d Follow app instructions to insert test strip Take a new test strip from the test strip vial hold the middle of the test strip with the arrow facing the meter and insert th...

Page 14: ...to compare your meter results with laboratory tests Refer to the instructions given by your physician or other qualified healthcare providers do not deviate from these instructions on the basis of the...

Page 15: ...se If the user tests 6 times every day the meter and lancing device should be cleaned and disinfected 6 times per day which equals 10950 cycles over the 5 year life of the devices The meter and lancin...

Page 16: ...Testing Pain is felt more readily on the fingertips because they are full of nerve endings receptors At other body sites where nerve endings are not so condensed pain is not felt as acutely When shou...

Page 17: ...below appear please contact iHealth Labs Customer Service Do not attempt to repair the meter by yourself and never try to disassemble the meter under any circumstances Troubleshooting Problems Possibl...

Page 18: ...Android or iOS mobile device can t begin testing when the meter is connected with the Android or iOS mobile device or when a test strip is inserted into the meter 2 Discoloration of the meter casing o...

Page 19: ...the limits for a C lass B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against har mful interference in a residential installation Th...

Page 20: ...ISPR 11 Group 1 Class B Home healthcare environment Harmonic distortion IEC 61000 3 2 Class A Home healthcare environment Voltage fluctuations and flicker IEC 61000 3 3 Compliance Home healthcare envi...

Page 21: ...riod of 3 years from the date of purchase by the original purchaser Warranty Period Under this Limited Warranty if a defect arises and a valid claim is received by iHealth within the Warranty Period r...

Page 22: ...Healthlabs eu Customer service https helpcenter ihealthlabs eu hc en gb requests new or menu Contact in App If you have questions or need assistance outside the operational hours and days please conta...

Page 23: ...y from direct sunlight or near heat sources Keep in a dry place Do not reuse Sterilized using irradiation Bluetooth sign Complies with the requirements of the European IVD Directive 98 79 EC This devi...

Page 24: ...FCC IC 20200819...

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