Andon Health BG5L iHealth Wireless Smart Gluco-Monitoring System User Manual BG5L OM EN 20130218

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For in vitro diagnostic use only
Read instructions before use For self-testing
iHealthTMWireless Smart Gluco‐Monitoring System (BG5L)
OWNER’S MANUAL
Table of Contents
INTRODUCTIN ............................................................................................................................... 3
PACKAGE CONTENTS................................................................................................................. 3
SETUP REQUIREMENTS ............................................................................................................ 4
INTENDED USE ............................................................................................................................. 4
How the Test Works? ..................................................................................................................... 5
IMPORTANT SAFETY INSTRUCTIONS .................................................................................... 5
IMPORTANT TESTING INFORMATION..................................................................................... 6
INFORMATION ABOUT ALTERNATIVE SITE TESTING (AST) ............................................. 7
What is Alternate Site Testing?................................................................................................. 7
What is the Advantage of Alternative Site Testing? ................................................................. 8
When to Use Alternative Site Testing? ..................................................................................... 8
PARTS AND DISPLAY INDICATORS ......................................................................................... 9
Glucose Meter........................................................................................................................... 9
Blood Glucose Test Strip ......................................................................................................... 10
SETUP PROCEDURES ............................................................................................................ 11
TESTING WITH A BLOOD SAMPLE ........................................................................................ 12
Offline measurement mode：(not using iOS device) ............................................................. 12
Apply the Test Strip ......................................................................................................... 12
Obtaining a Blood Sample ............................................................................................... 12
Apply Your Blood Sample ................................................................................................ 12
Read the Test Results ...................................................................................................... 12
Discard the Used Test Strips ............................................................................................ 12
Discard the Used Lancet .................................................................................................. 13
Online measurement mode：(with iOS device) ..................................................................... 13
Apply the Test Strip ......................................................................................................... 13
Obtaining a Blood Sample ............................................................................................... 13
Apply Your Blood Sample ................................................................................................ 13
Read the Test Results ...................................................................................................... 14
Discard the Used Test Strips ............................................................................................ 14
Discard the Used Lancet .................................................................................................. 14
Control Solution ............................................................................................................................ 14
Page 1 of 25
Performing an Offline Control Solution Test with Meter Alone (not using iOS device) ........ 15
I Performing an Online Control Solution Test (with iOS device) ........................................... 16
IMPORTANT INFORMATION ABOUT CONTROL SOLUTION TESTS............................... 17
METER MEMORY ........................................................................................................................ 17
Offline measurement mode：(not using iOS device) ............................................................. 17
Reviewing Test Results .................................................................................................... 17
Online measurement mode：(with iOS device) ..................................................................... 18
REFERENCE VALUE OF THE IHEALTH WIRELESS SMART GLUCOSE METER ......... 18
COMPARING GLUCOSE METER TEST RESULTS WITH LABORATORY RESULTS .... 18
Before Going to the Lab ......................................................................................................... 19
While at the Lab ...................................................................................................................... 19
IHEALTH WIRELESS SMART GLUCO-MONITORING SYSTEM SPECIFICATIONS...... 19
Maintenance and Storage of your Wireless SMART GLUCOSE METER ........................... 20
LIMITATIONS OF USE ................................................................................................................ 20
SYSTEM TROUBLE SHOOTING .............................................................................................. 21
Result Readings ...................................................................................................................... 21
Error Message ......................................................................................................................... 21
Trouble Shooting ..................................................................................................................... 22
IMPORTANT INFORMATION REQUIRED BY THE FCC ................................................. 24
Page 2 of 25
INTRODUCTIN
Thank you for purchasing the iHealth Wireless Smart Gluco-Monitoring
System (BG5L). Before using this product, please read the following contents
thoroughly and carefully. This manual provides important information to help
you use the system properly so you get accurate readings every time. Regular
monitoring of your blood glucose levels can help you and your doctor gain
better control of your diabetes. Due to its compact size and easy operation,
you can use the iHealth Wireless Smart Gluco-Monitoring System (BG5L) to
easily monitor your blood glucose levels on your own, anywhere, any time.
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.
PACKAGE CONTENTS
Wireless Smart Glucose Meter
Test Strips*
Lancing device
Clear alternate site testing device cap
Lancets*
Travel Case
Page 3 of 25
z
Owner’s Manual
Quick Start Guide
USB Charging Cable
Control Solution*
Note:
* These contents may vary according to geographic markets. You must check your package.
If any items printed on the package are missing from your package or the package is opened prior to
use, please contact the place of purchase for assistance.
The lancing device can be used several times, however, the lancet should be changed after each use.
SETUP REQUIREMENTS
The iHealth Wireless Smart Gluco‐Monitoring System (BG5L) is designed to be used with the
following iPod Touch ,iPad, iPhone models:
iPod Touch 5
iPhone 4S
iPhone 5
iPad4
iPad Mini
The iOS version of these devices should be V5.0 or higher.
INTENDED USE
The iHealth Wireless Smart Gluco‐Monitoring System (BG5L) should be used for:
•
Quantitative measurement of glucose in fresh capillary whole blood samples drawn from
the fingertip, palm, forearm, upper arm, calf or thigh
•
Single person measurement only and should not be shared
Page 4 of 25
•
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 (BG5L) should not be used for the diagnosis of
or screening for diabetes, or for neonatal use.
Alternate Site Testing (AST) should be done only during steady – state times when glucose levels are
not changing rapidly.
Control Solutions are intended for use with the Wireless Smart Gluco‐Monitoring System (BG5L).
Control Solutions can be used to check that the glucose meter and test strips are working properly
and that the measurement is accurate. These Control Solutions contain a known amount of glucose,
as indicated on the bottles. If you need to purchase additional Control Solution, you can call
Customer Service at +1‐855‐816‐7705.
How the Test Works?
The iHealth Wireless Smart Gluco‐Monitoring System (BG5L) monitors glucose levels by measuring
the amount of electrical currents that are generated when the glucose in your system reacts with the
reagent of a test strip. The strength of the current produced by the reaction depends on the amount
of glucose in the blood sample. The glucose meter measures the current and converts to the
corresponding blood glucose level.
IMPORTANT SAFETY INSTRUCTIONS
Please carefully read the following information before using the iHealth Wireless Smart
Gluco‐Monitoring System (BG5L). Always keep these instructions in a safe place for reference.
Misuse of the Wireless Smart Gluco‐Monitoring System can cause electrocution, burns, fire and
other hazards.
Page 5 of 25
z
The Wireless Smart Glucose Meter and lancing device are for single patient use. Do not use on
multiple patients. Do not share the Wireless Smart Glucose Meter or lancing device with anyone,
including other family members.
Do not place the Wireless Smart Glucose Meter in or near liquid.
Use the Wireless Smart Glucose Meter only for the purpose described in the Owner’s Manual.
Do not use accessories that are not supplied by the manufacturer.
Do not use the Wireless Smart Glucose Meter if it has suffered any damage or is not working
properly.
Keep the Wireless Smart Glucose Meter away from heat at all times. Do not let the Wireless
Smart Glucose Meter come into contact with surfaces that are hot to the touch.
Do not block test ports or place the Wireless Smart Glucose Meter on soft surfaces that may
block them. Keep test ports free from lint, hair, debris, etc.
Do not place anything on top of the Wireless Smart Glucose Meter.
Do not place foreign objects into any opening in the Wireless Smart Glucose Meter.
Please make sure it is not used by children or people who cannot express their own volition to
use it, and do not put the glucose meter in a place where it can easily be reached by children.
Do not use the Wireless Smart Glucose Meter where aerosol sprays are being used or where
oxygen is being administered.
Do not use in a manner not specified by the manufacturer.
IMPORTANT TESTING INFORMATION
Severe dehydration and excessive water loss may cause results that are lower than actual values.
If you believe you are suffering from severe dehydration, consult a healthcare professional
immediately.
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.
Use only fresh whole blood samples to test your blood glucose. Using other substances will
result in inaccurate results.
Page 6 of 25
z
If you are experiencing symptoms that are inconsistent with your blood glucose test results, and
you have followed all the instructions provided in this Owner’s Manual, contact your healthcare
professional.
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 individuals who are in a
hyperglycemic‐hyperosmolar state, with or without ketosis. Please consult your healthcare
professional before use.
INFORMATION ABOUT ALTERNATIVE SITE TESTING (AST)
There are limitations for doing AST. Please consult your healthcare professional before you conduct
AST. The Wireless Smart Gluco‐Monitoring System limits usage to steady‐state blood glucose
conditions only.
What is Alternate Site Testing?
Alternate Site Testing (AST) is blood glucose self‐monitoring using a blood sample collected from
somewhere other than the fingertips. The Wireless Smart Gluco‐Monitoring System (BG5L) allows
you to test on the palm, forearm, upper arm, calf, or thigh with equivalent results to fingertip testing.
Page 7 of 25
What is the Advantage of Alternative Site 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 to Use Alternative Site Testing?
Food, medication, illness, stress and exercise can affect blood glucose levels. Capillary blood from the
fingertips reflects these changes faster than capillary blood from other sites. Therefore, when testing
blood glucose levels during or immediately after one of these , such as meals or exercise, take a blood
sample from your fingertips only. AST should be done only during steady–state times when glucose
levels are not changing rapidly.
AST is suitable in the following instances:
In a pre‐meal or fasting state (two hours or more after the last meal)
Two hours or more after taking insulin
Two hours or more after exercising
Caution: AST should not be used to calibrate continuous glucose monitoring systems (CGMs).
Results from AST should not be used in insulin dose calculations. Do not use AST if:
You think your blood glucose is low
You believe you may be hypoglycemic
You are testing for hyperglycemia
Your routine glucose results fluctuate often
You are pregnant
Page 8 of 25
PAR
RTS AND DISPLAY INDICATORS
Gluccose Meter
Page 9 of 25
Bloo
od Glucose Te
est Strip
Eaach test strip is intended fo
or single use only and should be discard
ded immediately after use
e Test
strip
ps consist of th
he following parts:
Page 10
0 of 25
NOTE: Only use iHealth Blood Glucose Test Strip with the iHealth Wireless
Smart Gluco-Monitoring System (BG5L). Other test strips may produce
inaccurate results.
SETUP PROCEDURES
Prior to the first use, set the meter time by connecting the meter with your iOS
device via Bluetooth. Complete the steps below to have your desired time
settings saved in the meter.
After connecting to your iOS device via Bluetooth and launching the App, you
can view your measurement status and your test results on the screen.
1. Download the Free iHealth App
Prior to first use, download and install the free iHealth App from the App Store.
Use keyword search terms “iHealth,” “BG5L” or” iHealth Gluco-Smart.”
2. Account Setup and Registration
Follow the on-screen instructions to register and set up your personal account.
3. Connect the Glucose Meter to your iOS Device via Bluetooth
Press and hold the Memory Button for 3 seconds to turn the
meter on. Enable the Bluetooth function on your iOS device.
When the “
” symbol appears, the meter is in Bluetooth
communication mode.
4. Two-dimensional code scanning
Please scan two-dimensional code on the test strip vial after
establishing a Bluetooth c onnection, we will help you manage
your test strip
Page 11 of 25
TESTING WITH A BLOOD SAMPLE
Offline measurement mode：(not using iOS device)
Apply the Test Strip
Take a test strip from its vial. You may touch the test strip anywhere on its surface with clean dry
hands. Do not bend, cut or modify the test strips in any way. Use each test strip immediately after
removing it from the vial.
Insert the test strip into the test port of the glucose meter.
Obtaining a Blood Sample
The detailed procedure reference iHealth Lancing Device
Apply Your Blood Sample
Apply your blood to the blood sample area of the test strip, making sure the sample area is fully
covered with your blood sample. Please leave the test strip blood samples when the countdown
begins
Read the Test Results
After counting down to “1” the test result will appear on the meter display.
Note: The results obtained from the glucose meter are plasma‐calibrated. This helps you and your
physician or other qualified healthcare providers 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 result without first consulting your physician
Discard the Used Test Strips
Hold down the eject button to promote to the direction of the test strips, the test strips will leave a
Page 12 of 25
bloood glucose meeter. Discard the used test strips directly
y into the waaste containerr
Disccard the Used
d Lancet
Discard the used
d lancet directly into a container desig
gned for sharrp objects. Always wash hands
thoroughly with soap
and wateer after handliing the meterr, lancing device, test stripss.
Notee: Please consult a healthca
are professiona
al for interprettation of blood
d glucose measurements.
Online measurement mode：(w
with iOS de
evice)
App
ply the Test Strip
Takee a test strip from its vial. You may tou
uch the test strip
anywherre on its surfaace with clean dry
hand
ds. Do not beend, cut or mo
odify the testt strips in anyy way. Use eaach test strip immediately after
remo
oving it from the vial.
Insert the test striip into the tesst port of the glucose
meter.
If thhis is your IOS
S device's Bluuetooth functtion in the op
pen mode, theen the blood gglucose meterr will
autoomatically connnect the IOS
S device, and enter the onlline measurem
ment mode.
Bloood glucose meter line meaasurement moode only displlay the Bluetoooth symbol.
Obtaining a Blood Sample
The detailed proccedure referen
nce iHealth Laancing Device
App
ply Your Bloood Sample
Ap
pply your blood to the blo
ood sample arrea of the tesst strip, makin
ng sure the saample area iss fully
coveered with you
ur blood samp
ple. Your iOS device will beep
when yo
ou should rem
move the test strip
Page 13 of 25
from
m the blood saample
Read the Test Results
Yo
our blood gluccose results will
w be displayeed on the iOS device.
Notee: The resultts obtained froom the glucosee meter are pla
asma‐calibratted. This helps you and your
physsician or otherr qualified heallthcare provid
ders to comparre your meter results
with laaboratory testss.
Refeer to the instruuctions given by
b your physiciian or other qu
ualified health
hcare providerss, do not devia
ate
from
m these instrucctions on the basis
of the ressult without firrst consulting your
physician
n.
Disccard the Used
d Test Stripss
Holdd down the ejject button too promote to the
t direction of the test sttrips, the test strips will leaave a
bloood glucose meeter. Discard the used test strips directly
y into the waaste containerr
d Lancet
Disccard the Used
Discard the used
d lancet directly into a container desig
gned for sharrp objects. Always wash hands
thoroughly with soap
and wateer after handliing the meterr, lancing device, test stripss.
Notee: Please consult a healthca
are professiona
al for interprettation of blood
d glucose measurements.
For additional
infformation, please visit: www.ihealthla
abs.com
Co
ontrol Solution
Co
ontrol soluttion contain
ns a known amount of
o glucose that reactss with test
strrips and is used to en
nsure that your meter and test strips
are w
working
tog
gether prop
perly.
Page 14
4 of 25
Material needed:
z iHealth Wireless Smart Gluco-Monitoring System (BG5L)
z iHealth AGS-1000I Blood Glucose Test Strip
z Control Solution
Perform Control Solution test when:
z First receiving the meter
z Checking the meter and test strips at least once a week
z Using a new vial of test strips
z You suspect the meter or test strips are not working properly
z Your blood glucose test results are not consistent with how you feel, or if
you think the results are not accurate
z Practicing the testing process
z The meter has been dropped or damaged
Performing an Offline Control Solution Test with Meter Alone (not using
iOS device)
When taking a Control Solution Test with meter alone, it is important to set the
test mode to “CTL,” so that the result will not be mixed up with your regular test
results. Control Solution Test results will not be saved in the meter’s memory.
Please follow the instructions below.
Step 1: Insert the test strip to turn on the meter
Insert the test strip in the meter’s Strip Port, and wait for the Blood Sample
Symbol to appear in the meter display.
Step 2: Press the Memory Button to turn on the control (“CTL”) mode.
When the “CTL” symbol appears, the meter is in control
ode and will not save this test results in memory.
Step 3: Press the “Memory Button” again to turn off the
“CTL” mode and switch back to the regular testing
mode. When the “CTL” symbol disappears from the
meter display, the meter is in regular testing mode and subsequent tests will
not be treated as a control solution test.
Step 4: Apply Control Solution
• Shake the Control Solution vial before each use.
•
Squeeze a drop of Control Solution and place it in the vial cap. For
better results, it is recommended that you use the second drop of the
Control Solution (discard the first drop).
Page 15 of 25
•
Hold the meter and move the absorbent hole of the test strip to catch
the drop. Once the confirmation window fills completely, the meter will
start counting down. Please leave the test strip blood samples when the
countdown begins
Note: To avoid contaminating the entire vial of Control Solution, do not directly
apply Control Solution onto a strip.
Step 5: Read and Compare the Results
After counting down to “1” the Control Solution test result
will appear on the meter display.
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
specified range, repeat the test, carefully following the steps above.
I Performing an Online Control Solution Test (with iOS device)
Step 1: Launch the App
Step 2: Tap the “CTL” button to switch to Control (“CTL”) mode
Step 3: Follow Steps 1-4 of “Performing an Offline Control Solution Test”
Step 4: the Control Solution test result will appear on the iOS device.
Out-of-Range Results
Results falling outside the specified range may be caused by:
• Error in performing the test
• Expired or contaminated Control Solution
• Expired or contaminated test strip
• iHealth Wireless Smart Gluco-Monitoring System (BG5L) malfunction
If you continue to get Control Solution test results that fall outside of the range
printed on the vial, the meter may not be working properly. Discontinue use
and call iHealth Labs Customer Service at +1855-816-7705 for assistance.
To purchase additional Control Solution,
at +1855-816-7705.
call iHealth Labs Customer Service
NOTE:
Do not use expired Control Solution.
The control solution range printed on the test strip vial is for Control Solution
use only. It is not a recommended range for your blood glucose level.
Page 16 of 25
IMPORTANT INFORMATION ABOUT CONTROL SOLUTION TESTS
When performing a Control Solution test to check your glucose level, be sure
to select the Control Solution test on the app. Control Solution tests conducted
in regular testing mode will save results with regular test results, which may
yield inaccurate blood glucose levels.
METER MEMORY
Offline measurement mode：(not using iOS device)
The Wireless Smart Glucose Meter stores up to 500 of your most recent
blood glucose test results along with their respective dates and times.
Reviewing Test Results
1. Press and release “Memory Button” on the meter.
Press the Memory Button to view the test results stored in the meter. The first
reading you’ll see is your most recent blood glucose result.
Note: When the meter memory is full, the oldest test result will be deleted
automatically, and the newest test result will be saved.
2. Exit the Memory Mode
When you reach the last test result, the word “End” will appear, and the
meter will turn off automatically.
If you do not operate the meter in 30 seconds, it will turn off automatically.
Page 17 of 25
Online measurement mode：(with iOS device)
Press and hold the Memory Button for 3 seconds to turn the
meter on. Enable the Bluetooth function on your iOS device.
When the “
” symbol appears, the meter is in Bluetooth
communication mode.
You may perform a test even when the meter is not connected to
your iOS device via Bluetooth, and the meter will save up to 500
test results. launch the App and follow the on-screen instructions.
Test results will be transmitted to the App with date and time. If
the Bluetooth function disconnected, the meter will automatically shut off.
REFERENCE VALUE OF THE IHEALTH WIRELESS SMART GLUCOSE METER
Time of day
People without diabetes
Fasting and before meals
<100 mg/dL
2 hours after meals
<140 mg/dL
Source: (1) American Diabetes Association: Diagnosis and Classification of Diabetes Mellitus
(Position Statement). Diabetes Care 34 (Supp. 1) S66, 2011.
(2) Tietz Fundamentals of Clinical Chemistry, 6th Edition, Edited by Burtis CA and Ashwood ED, W.
B. Saunders Co., Philadelphia, PA, 2008, p. 849.
Please consult your healthcare provider to determine a target range that is best for you.
COMPARING GLUCOSE METER TEST RESULTS WITH LABORATORY RESULTS
The Wireless Smart Glucose Meter provides you with whole blood equivalent results. The result you
obtain from your glucose meter may differ somewhat from your laboratory results due to normal
variation. The Wireless Smart Glucose Meter results can be affected by factors and conditions that do
not affect laboratory results in the same way. To make an accurate comparison between the Wireless
Smart Glucose Meter and laboratory results, follow the guidelines below.
Page 18 of 25
Before Going to the Lab
Perform a Control Solution test to make sure that the meter is working properly.
If possible, fast for at least eight hours before conducting a comparison test.
Take your Wireless Smart Glucose Meter with you to the lab.
While at the Lab
Make sure that samples for both tests are taken and tested within 15 minutes of each other.
Wash your hands before obtaining a blood sample.
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: BG5L
2.
Machine size: 3.8’’× 1.35’’× 0.75’’ (96mm × 34.5mm ×19mm)
3.
Measuring method: Amperometric technology using glucose oxidase
4.
Result range: 20 mg/dL ~600 mg/dL (1.1 mmol/L ~33.3mmol/L)
5.
Power source: DC 3.7V
6.
Wireless communication:Bluetooth V4.0
, li‐ion 250mAh
Frequency Band:2.402‐2.480GHz
7.
Storage condition: Test Strips 39.2° F～86° F (4° C～30° C), Humidity ＜ 80% RH
8.
Storage condition: WIRELESS Smart Glucose Meter ‐4° F ‐ 131° F (‐20° C～55° C); Humidity
＜80%RH
9.
Operating conditions: 50°F～104°F (10° C～40° C)
10. Blood source: Fresh capillary whole blood
11. Blood volume: Min. 0.7 micro liter
12. Life span: Five years
Page 19 of 25
Maintenance and Storage of your Wireless SMART GLUCOSE METER
Always use care when handling the Wireless Smart Glucose Meter. Dropping or throwing the
meter may cause damage.
Don't expose the Wireless Smart Glucose Meter, test strips, or Control Solution to extreme
conditions such as high humidity, heat, freezing cold or dust.
Always wash your hands with soap and water, and rinse and dry them completely before
handling the Wireless Smart Glucose Meter and test strips.
LIMITATIONS OF USE
The iHealth Wireless Smart Glucose Meter is not intended for use on newborns.
The iHealth Wireless Smart Glucose Meter is not intended for use on artery blood, serum and
plasma.
The iHealth Wireless Smart Glucose Meter should only be used with iHealth test strips
(AGS‐1000I).
The iHealth Wireless Smart Glucose Meter can be used up to an altitude of 3276 meters
（10744feet）.
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 acid, acetaminophen, Dopamine, L‐dopa, etc. These substances do not affect
test results in normal concentration 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.
Not for use for patients in a hyperglycemic‐hyperosmolar state, with or without ketosis.
Not for use on critically ill patients.
Not to be used for patients who are dehydrated, hypertensive, hypotensive or in shock.
Very low or very high red blood cell count (hematocrit) can lead to incorrect test results. If you
Page 20 of 25
do not know your hematocrit level, please consult your healthcare provider.
We recommend periodic comparison of the iHealth Wireless Smart Gluco‐Monitoring System to
another monitoring system known to be well maintained and monitored by a healthcare provider.
SYSTEM TROUBLE SHOOTING
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.
Result Readings
MESSAGE
WHAT It Means?
ACTION
Blood glucose level is The message indicates
lower
than
20mg/dl very low blood glucose.
(1.1mmol/L)
Consult with your
healthcare professional.
Blood glucose level is The message indicates
higher than 600 mg/dl severe hyperglycemia
(high blood glucose).
(33.3mmol/L)
Seek immediate medical
assistance.
Error Message
MESSAGE
WHAT It Means?
ACTION
The meter’s battery has Please
charge
insufficient power.
battery.
the
Page 21 of 25
Problems have occurred Please use a new test
that are related to test strip strip and re-test.
use.
Problem with the meter.
Re-test with a new test
strip. If the problem
persists, please call
iHealth Labs Customer
Service at +1‐855‐816‐7705
for assistance.
The
environmental Please test at a higher
temperature is lower than environmental
50℉
temperature.
The
environmental Please test at a lower
temperature is higher than environmental
104℉
temperature.
Trouble Shooting
Problems
Possible Causes
Display remains blank 1. Battery power is too
after the test strip has
low for use.
been inserted into the 2. Too much time has
meter.
passed
between
inserting the test strip
and
performing
the test.
3. Test strip has not been
fully inserted into the
Solutions
1. Charge the
battery
2. Reinsert the
test strip into the
meter.
3. Reinsert the
test strip into the
meter, pressing
firmly.
Page 22 of 25
Test
results
are 1.
inconsistent or Control
Solution test results are 2.
not within the specified
range.
3.
Meter.
Not enough sample
in the Test Strip.
Test strip or Control
Solution has expired.
Test strip has been
damaged due to heat
or humidity so that
the sample cannot be
applied, or the speed
of application is too
slow.
System
is
not
performing due to the
environment
being
above or below room
temperature.
1. Re-test with a new
Test Strip and make
sure that enough
sample has been
applied.
2. Re-test with a new
Test Strip or new
Control Solution
3. Perform a Control
Solution
test
using a new Test
4.
Strip. If the results
are still out of
range,
replace
with new vial of
Test Strips.
4. Bring the system
to
room-temperature
environment and
wait approximately
30 minutes before
performing a new
test.
The meter countdown Test strip has not been
Use a new Test
did not start.
inserted correctly.
Strip and redo the
test.
In vitro diagnostic medical device
Serial number
Consult instructions for use
Consult instructions for use
Manufacturer
Environmental Protection– Waste electrical products should not be disposed of with
household waste. Please recycle where facilities exist. Check with your local authority or retailer for
recycling advice.
Page 23 of 25
Auth
horised repressentative in th
he European Community
FC
CC ID:Z
ZRYBG5
5L
Bluettooth sign
Keep dry
Complies with
w IVD98/79
9/EC require
ements
alth is a trade
emark of iHe
ealth Lab Inc.
iHea
“
for iP
Phone” mean
n that an elecctronic acces
ssory
“Made for iPod” “Made for iPad”and “Made
ned to connect specifica
ally to iPod, iPad,iPhone
e, respectivelly, and has been
has been design
to meet Apple
e performanc
ce standards. Apple is no
ot responsiblle for
certiified by the developer
the operation
of this device or
o its complia
ance with safe
ety and regulatory standa
ards. Please note
that the use of this
accesso
ory with iPod,iPad, iPhon
ne may affecct wireless pe
erformance. iPod
one are trade
emarks of Ap
pple Inc., reg
gistered in the
e U.S. and o
other countrie
es.
Toucch ,iPad,iPho
nufactured fo
or iHealth La
ab Inc.
Man
719 N. Shoreline
e Blvd., Mountain View, CA
C 94043, USA
855-816-7705 (toll-free frrom PST 8:30
0-17:30 of MON
to FRI)
+1-8
www
w.ihealthlabss.com
ANDON
N HEALTH CO.., LTD.
No. 3 Jin Ping
P Street, Ya
Y An Road, Naankai District,, Tianjin 30019
90, China
6161
Tel: +86‐22‐60526
EC
REP
Lotus
Global Co.,
C Ltd.
15 Alexandra Road, London UK
K, NW8 0DP
Tel: +0044‐20‐758
868010 Fax: +0044‐20‐7900
06187
IMP
PORTANT INFORMA
ATION REQ
QUIRED BY
B THE FC
CC
Thiss device comp
plies with Part 15 of the FCC
F Rules. Itss operation is subject to tthe following
g two
Page 24
4 of 25
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
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. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This product generates, uses, and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this product does cause harmful
interference to radio or television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following
measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
—Consult the dealer or an experienced radio/TV technician for help.
This product complies with Industry Canada. IC: RSS‐210
This product is approved in accordance to R&TTE directive transmitter.
IC NOTICE
This device complies with Industry Canada licence‐exempt RSS standard(s). Operation is subject
to the following two conditions: (1) this device may not cause interference, and (2) this device
must accept any interference, including interference that may cause undesired operation of the
device.
Page 25 of 25

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