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

Andon Health Co., Ltd iHealth Wireless Smart Gluco-Monitoring System BG5L OM EN 20130218

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Manual

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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

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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



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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

z WirelessSmartGlucoseMeter



z TestStrips*



z Lancingdevice



z Clearalternatesitetestingdevicecap



z Lancets*



z TravelCase

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

z Owner’sManual



z QuickStartGuide

z USBChargingCable

z 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

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• 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.

z MisuseoftheWirelessSmartGluco‐MonitoringSystemcancauseelectrocution,burns,fireand

otherhazards.

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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.

z DonotplacetheWirelessSmartGlucoseMeterinornearliquid.

z UsetheWirelessSmartGlucoseMeteronlyforthepurposedescribedintheOwner’sManual.

z Donotuseaccessoriesthatarenotsuppliedbythemanufacturer.

z DonotusetheWirelessSmartGlucoseMeterifithassufferedanydamageorisnotworking

properly.

z 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.

z 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.

z DonotplaceanythingontopoftheWirelessSmartGlucoseMeter.

z DonotplaceforeignobjectsintoanyopeningintheWirelessSmartGlucoseMeter.

z 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.

z DonotusetheWirelessSmartGlucoseMeterwhereaerosolspraysarebeingusedorwhere

oxygenisbeingadministered.

z Donotuseinamannernotspecifiedbythemanufacturer.

IMPORTANT TESTING INFORMATION

z 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.

z 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.

z Useonlyfreshwholebloodsamplestotestyourbloodglucose.Usingothersubstanceswill

resultininaccurateresults.

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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.

z 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.



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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:

z Inapre‐mealorfastingstate(twohoursormoreafterthelastmeal)

z Twohoursormoreaftertakinginsulin

z 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:

z Youthinkyourbloodglucoseislow

z Youbelieveyoumaybehypoglycemic

z Youaretestingforhyperglycemia

z Yourroutineglucoseresultsfluctuateoften

z Youarepregnant

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Page 11 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 12 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

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Page 15 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 16 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, call iHealth Labs Customer Service

at +1855-816-7705.

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 17 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 18 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 19 of 25

BeforeGoingtotheLab

z PerformaControlSolutiontesttomakesurethatthemeterisworkingproperly.

z Ifpossible,fastforatleasteighthoursbeforeconductingacomparisontest.

z 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.

z Washyourhandsbeforeobtainingabloodsample.

z Neveruseyourglucosemeterwithbloodsamplescollectedinatesttube.

z 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 ,li‐ion250mAh

6. Wirelesscommunication:BluetoothV4.0

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 20 of 25

Maintenance and Storage of your Wireless SMART GLUCOSE METER

z AlwaysusecarewhenhandlingtheWirelessSmartGlucoseMeter.Droppingorthrowingthe

metermaycausedamage.

z 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.

z 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

z TheiHealthWirelessSmartGlucoseMeterisnotintendedforuseonnewborns.

z TheiHealthWirelessSmartGlucoseMeterisnotintendedforuseonarteryblood,serumand

plasma.

z TheiHealthWirelessSmartGlucoseMetershouldonlybeusedwithiHealthteststrips

(AGS‐1000I).

z TheiHealthWirelessSmartGlucoseMetercanbeuseduptoanaltitudeof3276meters

（10744feet）.

z 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.

z Patientsundergoingoxygentherapymayyieldfalselylowerresults.

z Notforuseforpatientsinahyperglycemic‐hyperosmolarstate,withorwithoutketosis.

z Notforuseoncriticallyillpatients.

z Nottobeusedforpatientswhoaredehydrated,hypertensive,hypotensiveorinshock.

z Veryloworveryhighredbloodcellcount(hematocrit)canleadtoincorrecttestresults.Ifyou

Page 21 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

lower than 20mg/dl

(1.1mmol/L)

The message indicates

very low blood glucose.

Consult with your

healthcare professional.

Blood glucose level is

higher than 600 mg/dl

(33.3mmol/L)

The message indicates

severe hyperglycemia

(high blood glucose).

Seek immediate medical

assistance.

Error Message

MESSAGE WHAT It Means? ACTION

The meter’s battery has

insufficient power.

Please charge the

battery.

Page 22 of 25

Problems have occurred

that are related to test strip

use.

Please use a new test

strip and re-test.

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

temperature is lower than

50℉

Please test at a higher

environmental

temperature.

The environmental

temperature is higher than

104℉

Please test at a lower

environmental

temperature.

Trouble Shooting

Problems Possible Causes Solutions

Display remains blank

after the test strip has

been inserted into the

meter.

1. Battery power is too

low for use.

2. Too much time has

passed between

inserting the test strip

and performing

the test.

3. Test strip has not been

fully inserted into the

1. Charge the

battery

2. Reinsert the

test strip into the

meter.

3. Reinsert the

test strip into the

meter, pressing

firmly.

Page 23 of 25

Meter.

Test results are

inconsistent or Control

Solution test results are

not within the specified

range.

1. Not enough sample

in the Test Strip.

2. Test strip or Control

Solution has expired.

3. 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.

4. 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

Strip. If the results

are still out of

range, replace

with new vial of

Test Strips.

4. Bring the system

to a

room-temperature

environment and

wait approximately

30 minutes before

performing a new

test.

The meter countdown

did not start.

Test strip has not been

inserted correctly.

Use a new Test

Strip and redo the

test.

Invitrodiagnosticmedicaldevice

Serialnumber

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.

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Page 25 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.

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

Andon Health Co., Ltd iHealth Wireless Smart Gluco-Monitoring System BG5L OM EN 20130218

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