iHealth BG5S User manual

iHealth®
Wireless Smart Gluco-Monitoring System
Model: BG5S
OWNER'S MANUAL
For in vitro diagnostic use only
Read instructions before use for self-testing

Table of Contents
INTRODUCTION............................................................................................................................1
INTENDED USE.............................................................................................................................1
IMPORTANT SAFETY INSTRUCTIONS....................................................................................1
LIMITATIONS OF USE ..................................................................................................................2
CONTENTS OF THE WIRELESS SMART GLUCO-MONITORING SYSTEM.....................4
Parts and Displays .....................................................................................................................6
Mobile Device Compatibility....................................................................................................7
TEST PRINCIPLE ..........................................................................................................................8
IMPORTANT TEST INFORMATION............................................................................................8
TEST BLOOD GLUCOSE LEVEL ...............................................................................................8
DATA SYNCING ...........................................................................................................................13
REVIEWING SAVED TEST RESULTS ON THE METER......................................................13
CLEANING AND DISINFECTION..............................................................................................13
SIGNS OF POTENTIAL PHYSICAL AND PERFORMANCE DETERIORATION...............14
INFORMATION ABOUT ALTERNATIVE SITE TESTING (AST) ...........................................14
What Is Alternative Site Testing?............................................................................................14
What Is the Advantage of Alternative Site Testing?................................................................15
When Should You Use Alternative Site Testing? ....................................................................15
IMPORTANT INFORMATION ABOUT CONTROL SOLUTION TESTS...............................16
PERFORMING A CONTROL SOLUTION TEST .....................................................................16
Out-of-Range Results..............................................................................................................17
COMPARING GLUCOSE METER TEST RESULTS WITH LABORATORY RESULTS ....18
Before the Lab Test .................................................................................................................18
While at the Lab......................................................................................................................18
THE iHealth Wireless Smart Gluco-Monitoring System SPECIFICATIONS .......................18
MAINTENANCE AND STORAGE OF YOUR METER............................................................19
SYSTEM TROUBLESHOOTING...............................................................................................19
Display Messages....................................................................................................................19
Troubleshooting ......................................................................................................................21
WARRANTY INFORMATION .....................................................................................................22
EXPLANATION OF SYMBOLS..................................................................................................23
IMPORTANT INFORMATION REQUIRED BY THE FCC......................................................24
ELECTROMAGNETIC COMPATIBILITY INFORMATION .....................................................26

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INTRODUCTION
Thank you for purchasing the iHealth Wireless Smart Gluco-Monitoring System (the iHealth system . This
manual provides important information to help you use the system properly. Before using this product,
please read the Owner’s Manual thoroughly.
INTENDED USE
The iHealth Wireless Smart Gluco-Monitoring System (BG5S is intended to be used for the quantitative
measurement of glucose (sugar in fresh capillary whole blood samples drawn from the fingertip, palm,
forearm, upper arm, calf or thigh.
The iHealth Wireless Smart Gluco-Monitoring System (BG5S is intended to be used by a single person and
should not be shared.
The iHealth Wireless Smart Gluco-Monitoring System(BG5S is intended for 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 Wireless Smart Gluco-Monitoring System (BG5S should not be used for the diagnosis of or
screening of diabetes or for neonatal use.
Alternative site testing should be done only during steady - state times (when glucose is not changing
rapidly .
The AGS-1000I & EGS-2003 test strips are for use with the iHealth BG5S meter to quantitatively measure
glucose (sugar in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm,
calf or thigh.
The iHealth control solutions are intended for use with the iHealth BG5S Wireless Smart Blood Glucose
Monitoring System, to check that the glucose meter and test strips are working properly. These solutions
contain a known range of glucose, as indicated on the bottles.
The iHealth Gluco-Smart App is the application for the iHealth Gluco-Monitoring System, and is used for
data extraction and analysis.
In order to use the iHealth BG5S Wireless Smart Gluco-Monitoring System, a compatible Android or iOS
mobile device with the necessary mobile application installed is required.
IMPORTANT SAFETY INSTRUCTIONS
Please read the following information carefully before using the iHealth system. Always keep these

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instructions in a safe place for reference.
Misuse of the iHealth system can cause electrocution, burns, fire, and other hazards.
The meter and lancing device are for single patient use.
Do not use either item on multiple patients.
Do not share the meter or lancing device with anyone, including other family members.
Do not place the iHealth system in or near liquid.
The iHealth system can be used up to an altitude of 3276 meters (10744 feet .
Use the iHealth system only for the purpose described in the 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.
Do not block test port or place the iHealth system on soft surfaces that may block the test port. Keep
test port free from lint, hair, debris, etc.
Do not place anything on top of the iHealth system.
Do not place foreign objects into any opening in the iHealth system.
Do not use the meter in a manner not specified by the manufacturer.
All parts of the iHealth system are considered biohazards and can potentially transmit infectious
diseases, even after you have performed cleaning and disinfection.
Please refer to the resources identified below for detailed information:
“FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for
Transmitting Bloodborne Pathogens: Initial Communication” (2010
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
“CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens” (2010
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
LIMITATIONS OF USE
The iHealth system is not intended for use on neonates.
The iHealth system is not intended for use on artery blood, serum, and plasma.
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

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acid, acetaminophen, dopamine, L-dopa.
These substances do not affect test results in normal concentrations but may affect test results in high
concentrations. Do not use haemolysis samples, icterus samples, or high lipemia samples.
Patients undergoing oxygen therapy may yield falsely lower results
The glucose meter and lancing device are for single patient use
Not for use for patients in a hyperglycemic-hyperosmolar state, with or without ketosis.
Not for use on critically ill patients.
This device is not for use in people who are severely dehydrated, in people who are severely
hypotensive, or people who are in shock, consult your healthcare professional immediately when this
happens.
Use only fresh whole blood samples to test your blood glucose.
Very low or very high red blood cell count (hematocrit can lead to incorrect test results. If you do not
know your hematocrit level, please consult your healthcare provider.
For Over-the-Counter use
Do not perform AST if you think your glucose is low, you are unaware that you might have hypoglycemia,
you are testing for hyperglycemia, your AST results do not match the way you feel, your routine glucose
results fluctuate often
Do not use AST results to calibrate a continuous glucose monitor (CGM
Do not use AST results for insulin dosing calculations
If you take acetaminophen or acetaminophen containing medications (Tylenol, certain cold and flu
remedies, or certain prescription drugs higher than the recommended levels (>5 mg/dL then you
should know that this medication might affect the reliability of your blood glucose results and you
should not use this Blood Glucose Monitoring System. If you are unsure, than ask your doctor.
Certain conditions may cause your blood level of uric acid to rise. These conditions include gout or
kidney disease. Uric acid levels in your blood are measured by a laboratory test that your doctor orders.
You should know that if your blood level of uric acid is high (≥10 mg/dL then your blood glucose
results may be not reliable. If your doctor tells you that your uric acid level is greater than 10 mg/dL,
then do not use this blood glucose monitoring system. If you are unsure, then ask your doctor.
Vitamin C (Ascorbic acid (>2 mg/dL naturally in your blood or from food or taking Vitamin C
supplements might cause inaccurate blood glucose results when using this blood glucose monitoring
system.