iHealth BG1S User manual

iHealth®
Wireless Smart Gluco-Monitoring System（BG1S）
OWNER’S MANUAL
For in vitro diagnostic use only
Read instructions before use for self-testing

Table of Contents
INTRODUCTION 1
IMPORTANT SAFETY INFORMATION 1
Intended use 1
Limitations of use 1
Important safety instructions 2
YOUR NEW WIRELESS SMART GLUCOSE METER 3
Contents of the iHealth Wireless Smart Gluco-Monitoring System (BG1S) 3
Mobile device compatibility 6
TEST PRINCIPLE 6
CONTROL SOLUTION TESTS 6
Warning and precautions 6
Test procedures 7
Expected values 7
Important 8
BLOOD GLUCOSE TEST 8
Important information 8
First time setup instructions 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 you use Alternate Site Testing? 14
MAINTENANCE AND TROUBLESHOOTING 15
Maintenance and storage of your iHealth Wireless Smart Glucose Meter 15
System troubleshooting 15
Signs of potential physical and performance deterioration 16
iHealth WIRELESS SMART GLUCO-MONITORING SYSTEM SPECIFICATIONS 16
Technical specifications 16
Important information required by the FCC 17
Electromagnetic compatibility information 18
Warranty information 19
EXPLANATION OF SYMBOLS 21

1
INTRODUCTION
Thank you for purchasing the iHealth Wireless Smart Gluco-Monitoring System
(BG1S).
This manual provides important information to help you to use the system properly.
Before using this product, please read the Owner’s Manual thoroughly.
If you have questions regarding this product, please visit www.iHealthlabs.com,
contact your place of purchase, or call iHealth Labs Customer Service at 1-855-
816-7705 (Mon.-Fri. 8:30AM-5:30PM PST, Monday to Friday except holidays)
If you have questions or need assistance outside the operational hours and days,
please contact your healthcare provider.
IMPORTANT SAFETY INFORMATION
Intended use
The iHealth Wireless smart Gluco-Monitoring System (BG1S) consists of the
iHealth Wireless Smart Glucose Meter (BG1S), iHealth Test Strips (EGS-2003),
and the iHealth App mobile application.
The iHealth Wireless Smart Gluco-Monitoring System 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 is intended to be used by a
single person and should not be shared.
The iHealth Wireless Smart Gluco-Monitoring System 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 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).
Limitations of use
The meter and lancing device are for single patient use. Do not share them with
anyone including other family members! Do not use on multiple patients!
The iHealth system is not intended for use on neonates, nor for screening or
diagnosis.
Not for use on critically ill patients.
This device is not for use on people who are severely dehydrated, on people who
are severely hypotensive, or people who are in shock, consult your healthcare
professional immediately when this happens.
Use only fresh capillary 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 self-testing only.
Do not perform (Alternative Site Testing) 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) or for
insulin dosing calculations.
AST should only be used during times when blood sugar is not fluctuating rapidly,

2
i.e. Within 2 hours of eating, exercising or taking medication.
If you take acetaminophen or acetaminophen containing medications (Tylenol,
certain cold and flu remedies, or certain prescription drugs) this medication might
affect the reliability of your blood glucose results (blood concentrations >5
mg/dL). If you are unsure, then ask your healthcare professional.
Certain conditions may cause your blood level of uric acid to rise. These
conditions include gout or kidney disease. 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 you are unsure, then ask your healthcare professional.
Vitamin C (Ascorbic acid (>4 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.
Do not use this device during or shortly after receiving xylose absorption therapy
since xylose may cause inaccurate blood glucose results.
This device is not intended for use in healthcare or assisted-use settings such as
hospitals, physician offices, or long-term care facilities because it has not been
cleared by FDA for use in these settings, including for routine assisted testing or
as part of glycemic control procedures. Use of this device on multiple patients may
lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C
Virus(HCV), Hepatitis B Virus(HBV), or other 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). Always keep these instructions in a safe
place for reference.
Do not change your therapy based on a test result that does not match what
you feel or if you believe that your test result could be incorrect.
If your blood glucose result does not match what you feel and you have
followed the instructions in this Owner’s Manual, follow your healthcare
professional’s instructions, or contact your healthcare professional.
Always use a new, sterile lancet each time you test to avoid infection. For
safety reasons, once you use a new lancet, you cannot go back to a used
lancet, never reuse any lancet.
Swallowing battery can be extremely dangerous. Keep the batteries and the unit
out of the reach of children and disabled persons.
The meter and lancing device are for single patient use.
Do not use either item on multiple patients.
Never share the meter or lancing device with anyone, including family members.
Do not place the iHealth system in or near liquid.
The iHealth system can be used up to an altitude of 10744 feet (3275 meters).
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 test port free from lint, hair, debris, etc.
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.

3
All parts of the kit 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
YOUR NEW WIRELESS SMART GLUCOSE METER
Contents of the iHealth Wireless Smart Gluco-Monitoring System (BG1S)
Package contents vary from country to country. Please refer to the package
contents listed on the package you purchased.
Note: If any item s printed on the package are missing from your package or the
package appears to have been opened prior to y our use, please contact iHealth
Customer Care.
Remove the batteries if the blood glucose meter will not be used for a month or
more to avoid relevant damage of battery leakage.

4
The meter:
iHealth Test Strips
Use iHealth test strips EGS-2003.
Do not use the test strips if expired.
To keep your test strips in the best possible condition, read the following
recommendations thoroughly:
Write the expiry date on the test strips vial when first opening. The expiration date
can be found at the bottom of the box in which the vial was received in.
Store the test strips vial between 39°F ~ 86°F (4° C to 30° C) and 10% ~ 85%
relative humidity.
Keep the test strips away from 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 promptly after removing it from the vial. Close the vial lid quickly
after removing a new test strip.
Keep the vial lid closed at all times.
Do not bend, cut or alter the test strips. Doing so will lead to inaccurate results.
Do not use if vial is damaged.
Each test strip can be used only once, and consists of the following parts.
Refer to the test strips Instruction Book to have more details on how to use the test
strips with your meter.
iHealth Wireless Smart Gluco-Monitoring System:

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%.

6
Do not expose to direct sunlight or place near heat sources.
Use before the expiry date mentioned on the vial.
Use the control solution within 90 days of initial opening of the vial.
Close the vial immediately after each use.
To avoid contamination of the control solution, do not apply directly it to the test
strip from the bottle.
Dispose of used equipment according to regulations applicable in your country.
Refer to the Control Solution tests part to know how to use the Control Solution
with your meter.
Mobile device compatibility
iOS device with iOS 9and above, Android Phone with Android 5and above.
For a complete list of compatible devices, visit our support on page on
https://ihealthlabs.com/ihealth-compatibility-list
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. The strength of the current produced by the reaction depends on the amount
of glucose in the blood sample.
CONTROL SOLUTION TESTS
The iHealth Control Solution is intended to be used with the iHealth Wireless Smart
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 test results.
Materials needed to perform a control solution test:
iHealth Wireless Smart Glucose Meter
iHealth Test Strips (EGS-2003)
iHealth Control Solution (Level I, Level II, or Level III)
Perform a control solution test when:
The iHealth Control Solution is used to ensure the iHealth Wireless Smart Gluco-
Monitoring System (BG1S) are working correctly together and are not defective.
It should also be used in the following situations:
First receiving or purchasing the meter.
Each time you open a new vial of test strips.
If you suspect a dysfunction of the meter or test strips.
To familiarize yourself with the practice of testing.
If you suspect that the results are not accurate.
After the meter has been dropped.
Users should perform a control solution test at least once a week.
Warning and precautions
The iHealth control solution is intended to be used for in vitro diagnostic only.
Do not swallow or ingest the control solution.
The iHealth control solution is recommended to confirm the performance of the
system and can’t under any circumstances be substituted for a capillary blood test
to test your blood glucose level.
The control solution should be used before the expiry date printed on the bottle
label.

7
The control solution must be used within 90 days of opening the vial
(Shelf-life after opening)
Do not use the control solution after the expiry date or after the shelf-life after
opening, whichever comes first, at the risk of getting erroneous results.
Test procedures
Follow these instructions and refer to the iHealth Wireless Smart Gluco-Monitoring
System (BG1S) Owner's Manual for further information.
Step 1
Follow instructions on App’s user guide to operate the iHealth App
Step 2
Insert the test strip into the strip port.
Step 3
Shake the control solution vial vigorously before each use.
Press a drop of control solution onto a clean plastic surface (for example, the bottle
cap). For best results, we recommend to throw out the first drop and use the
second to perform your measures.
Then hold your meter and put the test strip absorbent hole into 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.
Note: To avoid contamination of the control solution, do not apply it directly to the
test strip from the bottle.
Step 4
The test result with the control solution is displayed on your smartphone screen.
Compare the result with the range of values printed on the test strips vial label.
Please take the below picture as an example.
The result must be within the specified range. If the test result is out of range,
please repeat the test.
Expected values
Refer to the specified range on the test strips vial label. Several factors can cause
out-of-range test results, including:
The previously mentioned test instructions have not been followed.
The control solution is contaminated, out-of-date or its shelf-life after opening is
exceeded.
The test strip is damaged or out-of-date.
The plastic surface that received the drop of control solution during measurement

8
was not wiped.
The storage temperature of the control solution (between 2°C and 30°C) has not
been observed.
iHealth Wireless Smart Gluco-Monitoring System (BG1S) is faulty.
Important
If test results with the control solution continue to fall outside the range of values
printed on the iHealth Test Strips vial, do not use the meter, test strips, or control
solution and contact iHealth Customer Care.
BLOOD GLUCOSE TEST
Testing with the iHealth Wireless Smart Gluco-Monitoring System (BG1S) is based
on the measurement of electrical currents generated by the reaction of glucose
with the reagent of the test strips. The iHealth Wireless Smart Gluco-Monitoring
System (BG1S) measures the current and converts it to the corresponding blood
glucose level. The strength of the current produced by the reaction depends on the
amount of glucose in the blood sample.
Important information
Please read the following:
Severe dehydration and excessive water loss may cause inaccurate results. If you
believe you are suffering from severe dehydration, consult your healthcare
professional immediately.
Inaccurate results may occur in severely hypotensive individuals or patients who
are in shock. Test results that are lower than actual values may occur in individual
who are in a hyperglycemic-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 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.
If you are experiencing symptoms that are inconsistent with your blood glucose
test, and you have followed all of the instructions provided in this Owner’s Manual,
contact your healthcare professional immediately.
Do not use test strips that are expired or appear to be damaged at the risk of
receiving inaccurate results. Please refer to the test strips Instruction Book for the
detailed procedure.
The iHealth lancing device is for self-use only. Do not share or re-use lancets.
Please refer to the Lancing Device Manual for the detailed procedure.
For more detailed information, please refer to the resources identified below:
“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