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

Manual

Page 1 of 25 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 2 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 3 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 z WirelessSmartGlucoseMeterz TestStrips*z Lancingdevicez Clearalternatesitetestingdevicecapz Lancets*z TravelCase
Page 4 of 25 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
Page 5 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. z MisuseoftheWirelessSmartGluco‐MonitoringSystemcancauseelectrocution,burns,fireandotherhazards.
Page 6 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.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.
Page 7 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.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.
Page 8 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: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
PARGlucRTS AND DIcoseMeterSPLAY INDICATORS Page 9 9 of 25
BlooEastripodGlucoseTeachteststrippsconsistofthestStripisintendedfohefollowingporsingleuseparts:onlyandshouldbediscarddedimmediaPage 10 telyafteruse0 of 25 eTest
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 Hold down the eject button to promote to the direction of the teststrips, the teststrips will leave a
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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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.
EC FC iHea“Mahas certithe othat Touc Man719 +1-8www Tel:+15ATel:+IMPThisCREP AuthCC ID:Z Bluet Keep dalth is a tradede for iPod” been designified by the doperation of the use of tch ,iPad,iPhonufactured foN. Shoreline855-816-770w.ihealthlabsANDONNo.3JinP+86‐22‐60526LlexandraRoa+0044‐20‐758PORTANT sdevicecomphorisedrepresZRYBG5tooth sign dry Complies wemark of iHe“Made for ned to conndeveloper tothis device othis accessoone are tradeor iHealth Lae Blvd., Mou5 (toll-free frs.com NHEALTHCO.PingStreet,Y6161LotusGlobalCd,LondonUK868010Fax:+INFORMAplieswithPasentativeinth5L with IVD98/79ealth Lab InciPad”and “ect specifica meet Appleor its compliaory with iPodemarks of Apab Inc. ntain View, Crom PST 8:30.,LT D. YaAnRoad,NaCo.,Ltd.K,NW80DP0044‐20‐7900ATION REQrt15oftheFheEuropeanC9/EC require. “Made for iPally to iPod, e performancance with safe,iPad, iPhonpple Inc., regCA 94043, U0-17:30 of MankaiDistrict,06187QUIRED BFCCRules.ItsCommunityements Phone” meaniPad,iPhonece standardsety and regune may affecgistered in theSA MON to FRI),Tianjin30019BY THE FCsoperationin that an elece, respectivel. Apple is nolatory standact wireless pee U.S. and o90,ChinaCC ssubjecttotPage 24ctronic accesly, and has bot responsiblards. Please erformance. other countriethefollowing4 of 25 ssory been le for note iPod es. gtwo
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.

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