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1 | Owners manual | Users Manual | 1.26 MiB |
INTOUCHBLOODGLUCOSE MONITORINGSYSTEM OWNERSMANUAL V1.6 1 CONTENTS Chapter1YourInTouch..................................................5 5 YourInTouch 6 RegisterYourInTouch 7 ContactUs 7 ImportantStayingSafe 9 UsingThisUserGuide Chapter2Overview........................................................10 IndicationsforUse 11 13 YourDoctor Chapter3Components.....................................................14 14 InTouch 14 GlucoseTestStrips 15 ImportantInTouchGlucoseTestStripInformation 16 LancingDevice 18 ControlSolution Chapter4GettingStarted................................................19 19 TurningOnandSettingupyourInTouch 22 YourInTouchMonitor 24 TheDisplayScreen Chapter5CheckingYourBloodGlucose..........................25 25 BeforeTesting 25 SafetyTips 26 HowToTest 31 MealtimeTags 32 Feeling 34 ChangingYourSelections 36 IfDataTransmissionIsUnsuccessful Chapter6WhatDoYourResultsMean?...........................38 38 BloodSugar 38 HighOrLowReadings 39 References Chapter7ForearmorPalmTesting..................................40 2 40 HowtoTest 41 Limitations&Considerations Chapter8ViewingResultsandTrends.............................43 44 Logbook 44 MealtimeValues 46 Patterns&Stats 48 StepsandCalories 50 SnapshotSummary Chapter9YourMessages.................................................51 51 Messages 52 Team 53 MyCoach 53 MyMD 55 MyFamily 56 MyMobile Chapter10YourPersonalWebPortal..............................57 57 LoggingIn 58 Dashboard 58 MoreDetail Chapter11CheckingyourInTouch...............................60 60 TheControlSolutionTest 61 UsingControlSolution 65 ControlSolutionTroubleshooting 66 ImportantTips Chapter12Maintenance..................................................68 68 Cleaning 69 Battery 71 StoringYourInTouch&TestStrips Chapter13SettingsOptions.............................................73 73 Help 73 AirplaneMode 75 ActivityMonitorSettings 76 Reminders 76 CalibrateControl 78 About Chapter14Troubleshooting.............................................79 79 IssuesWithTests 79 BasicTroubleshooting 80 ErrorMessages 81 CommunicationErrors 3 82 GettingSupport Chapter15SpecificationsandLimitations.......................83 83 Specifications 83 OperatingRanges 83 GlucoseTestImprecision 84 Environmental 84 Limitations Chapter16WarrantyandCompliance.............................86 86 LimitationsOnWarranty 87 ForWarrantyService 87 FCCInterferenceStatement 88 FCCCaution 88 FCCRadiationExposureStatement 88 PrivacyPolicy USPatentNo.7,935,307,8,066,640,6,837,976,6,942,770,andotherUSand foreignpatentspending.InTouchisatrademarkofEosHealth,Inc.Copyright 2013EosHealth,Inc.09/10/2013v1.1 4 Chapter1YourInTouch ThankyouforchoosingInTouchTMyourgatewayto bettermanagementofyourdiabetes.YournewIn TouchTMsystemwillmonitoryourglucoseandyour dailyphysicalactivitytohelpyouleadahealthierlife. Thisuserguidehasimportantinformationonyournew systemandhowitworks.Pleasereaditcarefully beforeusingInTouch,itwillhelpyoumakethemost ofyournewInTouch, YourInTouch YourInTouchiseasytouse.Ithasacolortouch screendisplaywhichwillshowyourbloodglucose, viewtrends,sharewithyourhealthcareteam,and viewandretrievepersonalizedmessages. 5 Itgivesaccurateglucosetestresultsinjust5 secondsusingaverysmallbloodsample.Thissmall sampleallowsyoutouseathinnerlancetbecause notasmuchbloodisneededtodoaglucosetest. Itsalotlesspainful. InTouchhasamemorythatstoresyourglucoseand activityresults.Italsoautomaticallysendsallyour datadirectlyandsecurelytoyourpersonalizedhealth accountwirelessly.Youcanalsochoosetosendyour resultstoyourhealthcareteamandreceive personalizedadvicetohelpyou,yourcoach,andyour healthcareprofessionaltomanageyourdiabetes. Itevenletsyouknowwhenyouarerunningoutoftest stripsandneedtoreorder.Butremember,InTouch isnotintendedtoprovideautomatedtreatment guidanceordecisions,norisitasubstituteforyour professionalhealthcareprovider.Itsaguideanda helper. RegisterYourInTouch Beforeyougetstarted,pleasefillouttheWarranty Registrationcardincludedinyourkitandmailthe cardbacktotheaddressprintedonthecard,or completetheWarrantyRegistrationonlineat:
www.InTouch.eoshealth.com Weusetheinformationcollectedtoimproveour service. 6 ContactUs InTouchismadebyEosHealth,Inc. 2800PostOakBoulevard, 4100Houston,Texas77056 InsidetheUSA,pleasecallCustomerServicetoll freeat18009454355orvisitourwebsiteat:
www.InTouch.eoshealth.com OutsidetheUSA,pleasecontactyoursupplierfor support. ImportantStayingSafe Pleasetakeamomenttoreadthroughthis importantsafetyinformation.Remember,thisis amedicaldeviceanditneedstobetreatedwith respect. TheInTouchBloodGlucoseMonitoringSystem andlancingdevicemustonlybeusedbyone person.Forsafetyreasons,donotshareitwith anyone,includingyourfamilymembers. Manypartsofyourdevicecomeintocontactwith yourblood.Kitpartscanpotentiallytransmit infectiousdiseases,evenafterbeingcleanedand disinfected. 7 Alwayswashyourhandsthoroughlywithsoapand wateranddrywellafterhandlingthemeter,test strips,oryourlancingdevice. Alwaysconsultyourdiabeteshealthcare professionalandfollowhisorherguidanceabout yourbloodglucosemonitoringroutine. Therecommendationsinthismanualapplytoall bloodglucosemonitorsandaresupportedbythe AmericanAssociationofDiabetesEducators
(AADE),theAmericanDiabetesAssociation(ADA), theUSFoodandDrugAdministration(FDA),and theAdvancedMedicalTechnologyAssociation
(AdvaMed). Ifthisdeviceisusedinamannernotspecifiedby themanufacturer,theprotectionprovidedbyit againsthazardsmaybeimpaired. TheInTouchGlucoseMonitoringSystemis deliveredfullyassembledandrequiresno additionalassembly. 8 UsingThisOwnersManual Wehaveincludedsomehelpfuladditionstothisuser manual.Theseare:
NOTEShelpfulinformationfordaytodayuse. CAUTIONSimportanttipsonprotectingyour glucometer. WARNINGScrucialinformationthatwillhelpyouuse yourglucometersafelyandcrucialinformationabout therisksofreceivinginaccuratereadings. 9 Chapter2Overview IndicationsforUse TheEosHealth,Inc.InTouchBloodGlucose MonitoringSystem(alsoknownasInTouch)uses anelectrochemicalenzymaticassayforthe quantitativedetectionofglucoseinfreshcapillary wholebloodfromthefingertip,forearm,andpalm bypeoplewithdiabetesathomeasanaidin monitoringtheeffectivenessofdiabetescontrol programs.Fingertip,forearmandpalmtestingsites shouldbeusedalternatelyonlywhenbloodglucose levelisnotchangingrapidly. TheInTouchBloodGlucoseMonitoringSystemis ahandhelddevicethatiscomposedofablood glucosemeter,pedometer,andGSMcellularradio. TheInTouchBloodBloodGlucoseMonitoring SystemmakesuseofitsGSMradiototransmit glucometerandpedometerdatabacktoaserver andreceiveinformationfordisplayinresponse. TheInTouchBloodGlucoseMonitoringSystemis intendedtobeusedbyasinglepatientandshould notbeshared.Itisforinvitrodiagnosticuseonly. Thisdeviceisnotindicatedforthediagnosisor screeningofdiabetes. 10 Alternativesitetestingcanbeusedonlyduring steadystatebloodglucoseconditions. Alternativesitetesting(AST)shouldnotbeused tocalibratecontinuousglucosemonitors(CGMs) norforuseininsulindosecalculations. TheInTouchTMBloodGlucoseMonitoringSystem andStripsaretobeusedwiththeInTouchBlood GlucoseMonitoringSystem;itmeasuresglucosein capillarywholebloodfromthefingertip,forearm andpalm. ForInVitroDiagnosticUse YourInTouchBloodGlucoseMonitoringSystem measurestheglucoseinyourbloodandalso measuresyourlevelofphysicalactivity.Thinkofit likeahealthcoachwhocanhelpyoufeelyourbest. YoucanuseInTouchathome,orinclinical settingstohelpyouwiththemanagementand treatmentofyourdiabetes. Pleasenotethatthisdeviceisnotintendedtobe usedfordiagnosisorscreeningfordiabetes mellitusandshouldnotbeusedwithnewlyborn babies. YourInTouchtakesglucosemeasurementsfrom smallbloodsamplestakenfromyourfingertip, forearm,orpalm. Pleasenote:
11 InTouchmustonlybeusedoutsidethebody(in vitrodiagnosticuse). ItshouldonlybeusedwithInTouchblood glucoseteststripsandInTouchcontrolsolutions. Itshouldonlybeusedfortestingglucose(sugar) withfreshcapillarywholebloodsamples. ItshouldNOTbeusedtodiagnoseDKAortotest newborns. ItshouldNOTbestoredintherefrigeratororinthe car. WARNINGS:
1. YourInTouchcontainssmallparts.Keepitoutof thereachofsmallchildrenandpets. 2. Ifyouhavehypoglycemiaunawareness,ablood glucosemonitoriscriticaltoyourcare.Sinceany monitormayfail,break,orbemisplaced,you shouldalwayshaveabackupmonitor. 3. Bloodsamplesandbloodproductsarepotential sourcesofhepatitisandotherinfectiousdiseases. Handleallpartsofyourdevicewithcare.Wear gloveswhenperformingmeasurementsonanother person.Anyitemsthatareusedtomeasureglucose liketeststrips,lancets,andalcoholswabs,mustbe disposedofsafelyinaccordancewithlocal regulationstoavoidtheriskofinfection. 12 YourDoctor PleaseusyourInTouchwithcare.Ifyouexperience symptomsthatarenotconsistentwithyourblood glucosetestresults,andyouhavefollowedallthe instructionsdescribedinthisUsersGuide,consult yourdoctororhealthcareprofessionalimmediately.It isalwaysbettertobesafe. 13 Chapter3Components InTouch Youhaveeverythingyouwillneedinyourbox.Your newInTouchdevicewillbereadytogoandwill alreadybepartlycharged.Tochargeitfully,youwill needtoplugitinovernight.Undernormaloperating andbloodglucosemonitoringconditions,thecharge shouldlastforseveralweeks. Youwillalsofindthefollowing:
Lancingdeviceandlancets. Control(Normal)solution(1bottle). QuickStartGuide. ACchargerandUSBcord. Warrantycard. Carryingcase(oracoupontoredeemoneofyour InTouchbloodglucoseteststrips(10). choice). GlucoseTestStrips TheInTouchGlucoseTestStripsaredesignedforuse withyourInTouchMonitoronly.Useeachteststrip 14 onlyonce,andthendiscardit.DONOTreapplyblood totheteststrip.Thisisveryimportant. Theycomeinavarietyofcolorstohelpyoukeeptrack ofwhichyouhaveused,buttheyallgiveidentical results.Theycomeinvialsandalsoasindividually sealedpackageswithasingleteststrip. InTouchGlucoseTestStripsrequireonlyaverysmall bloodvolume(0.6Lforglucose)andautomatically drawbloodintothetestareaofthestrip.Theycanbe handledwithclean,dryhandswithoutaffectingthe readings.Theyareveryconvenientwhetheryoutestat homeoronthego. ImportantBloodGlucoseTestStripInformation Pleaseremember:
UseonlyInTouchBloodGlucoseTestStripswhen testingforglucose. Removetheteststripfromthevial/foilonlywhen readytotest. Storetheteststrippackageinacool,dryplace below86F(30C).Donotrefrigerateorfreeze. 15 Donotstoretheteststripsnearheatormoisture. Storetheteststripsintheiroriginalpackagingonly. Afterremovingaglucoseteststripfromthevial, immediatelyreplacethecapandclosethevial tightly. Donotuseteststripsbeyondtheexpirationdate printedonthepackageasthismaycause inaccurateresults. Teststripsshouldonlybestoredfor3monthsafter opening.Discardanyremainingteststripsafterthis date. Donottamperwiththeteststrips. WARNING:Theteststripvialsandpackagingcontain smallparts.Keepawayfromchildrenandpets. LancingDevice Thediagrambelowshowsyourlancingdevice.Thisis thepartoftheInTouchwhichtakesthesample. Touseit,youshould:
1.Removetheendcap(A,topleft)bygentlypushing downandawayfromthelancingdevice. 16 2.Insertthelancet(B)firmlyintothelancetholder untilitcomestoastop. 3.Removetheprotectivelancetcover(C)byholding thelancingdevicefirmly.Twistandpulloffthelancet covertoexposethetip. DONOTTOUCHTHELANCETTIP. 4.Replacetheendcapbysnappingitbackontothe lancingdevice. 5.Selecttheskinpenetrationdepthbyturningthe depthselector(F)untilthedesirednumbercanbe seeninthedepthselectionwindow.Thelancing deviceoffersfivelevels:1forsoftskin;23for averageskin,and45forthickorcallousedskin. 6.Pullbackonthelancingdeviceuntilitcomestoa stop.Thecockingmechanismwillreturntoits originalpositionuponrelease. 7.Placethelancingdevicefirmlyagainstyourfinger andpressthereleasebuttontoobtainablood sample.Thelancetwillreturntoitsoriginalposition afteruse. 8.Afterfinishingyourbloodcheck,removetheend cap,carefullyremovetheusedlancet,anddisposeof thelancetsafelyinanappropriatecontainer. 9.Foralternativesitetesting,pleaseseeChapter7. 17 ControlSolution YourkitincludesacontrolsolutiontocheckyourIn Touchandteststripsareworkingproperly.The controlsolutionisaliquidthatcontainsafixedamount ofglucose.ItisusedtocalibrateyourInTouchand makessureyourreadingsareaccurate. Youcanalsousethissolutiontopracticetaking readings,ortocheckthatyouarefollowingthecorrect testingprocedurewithoutusingyourownblood.Ifthe monitorreadingiswithinthecontrolsolutions acceptablerange,themeterisworkingcorrectly. 18 Chapter4GettingStarted TurningOnandSettingupyourInTouch Youneedtodoverylittletosetupanduseyour monitor.Itwillpartiallychargebutyourchecktomake surethatthebatteryisatleast50%fullbeforeusingit forthefirsttime. Tocheckthebatterystatuslookatthebatterygauge iconinthetopleftofyourscreen,andthebarswithin theicon. 19 BylightlypressingthesideOn/Offbutton,theWake Upscreenwillappear.Itwillbeepforafewsecondsas itfindsthenetworkandautomaticallysetsthetime anddayfollowedbytheHomescreen. Thetimeanddatearesetautomatically,nomatter whereyouare,andareshownatthetopoftheHome screen.Ifyouaretraveling,InTouchwillsetyour monitorstimetothetimezonethatyouareinsothat yourmeasurementswillbesentwithrighttimestamp. Havingthecorrecttimeanddateofeachbloodtest resultisimportantbecauseithelpsyouandyour healthcareprofessionalunderstandyourbloodglucose 20 patternsandcanbeusedtotrackchangesinyour managementplan. InTouchwillalsoautomaticallydetectthewireless networkthatyouareinandroamifnecessary.There isnochargetoyouforroamingorwireless connections. CAUTION:AlwayshandleyourInTouchwithcare. Droppingtheunit,orexposingittowaterforexample maydamagethesensitivemonitoringequipment inside.Ifyouarepackingawayyourunitforan extendedperiodoftime,protectitfrommoisture, prolongeddirectsunlight,andextremetemperatures. Lookafterit,anditwillkeeplookingafteryou. 21 YourInTouchMonitor 1. On/Offbutton. 2. Colortouchdisplayscreen. 3. Teststripport. 4. USBchargingport. 22 5. Wirelesssignalindicator. 6. Batterychargeindicator. 23 TheDisplayScreen 1. Signalstrength. 2. Currentdateandtime. 3. Batterylevelandchargingstate. 4. Checkyourbloodglucoselevel. 5. Trendsforinformationonyourperformance. 6. Messagesyoushouldcheck. 7. Settingsformakingsureyourdeviceworks perfectly. 8. TeamtosendyourinformationtoMyCoach, MyMD,MyFamily&MyMobile. 24 Chapter5CheckingYourBloodSugar BeforeTesting Beforetestingandtoensureaccurateresults,wash andthoroughlydryyourhandsandthetestingsite. InTouchcantestbloodglucoseonthefingertips, forearm,orpalm.Thesamplesizeisjust0.6L(Glu)of blood.Thisminimizespain. SafetyTips Followthecleaninganddisinfectinginstructionsfor themeterandlancingdevicetopreventtheriskof bloodbornepathogens. Themeterandlancingdeviceareintendedfora singleuserandshouldneverbeshared. Washyourhandswithsoapandwarmwater,then drythoroughly.Alternatively,usealcoholpadsto cleantheareatobetestedanddryitthoroughly aftercleaning. NOTE:Cleaningofthepuncturesiteisimportant. 25 HowToTest 1. Tosavepower,themeterwillgotosleepwhennot beingused.PoweronandwakeuptheInTouch bypressingtheON/OFFbuttonontherightsideof themeter,orbytappingtheCheck/Testicononthe Homescreen. Whenthepowercomesonyouwillsee:
26 2. Youcanalsowakeupthemeterbyinsertinga glucoseteststripintothemonitor. 3. PressCheck,inthetoplefthandcorner. 4. ThescreenwilldisplayReadytoCheckGlucose. 5. Afingerwillappearonthescreentopromptyouto applyabloodsample.Thelastbloodglucosevalue andthecurrentsteps/caloriesaredisplayedatthe bottomofthescreen.Youcancancelthetestat anytime. NOTE:Ifthestripisremovedbeforeyoustartthetest, thescreenwillgoblankandreturntotheHomescreen. NOTE:Ifatestisnotperformedafterinsertingthetest strip,thedevicewillwaitindefinitelyuntilthestripis removedoruntilthetestiscancelled. 27 6. Holdinghanddownwards,massagefingerwith thumbtowardstiptostimulatebloodflow. 7. Usethelancingdevice,loadedwithanewlancet,to puncturethefinger.(Seelancingdeviceinstructions foruse.) 8. Squeezethefingertoformadropofblood. Touchtheendoftheteststriptotheblooddropuntil theteststripisfull.Whiletestisinprogress,ahelpful tiporpersonalmessageappears.Whenyouhave finishedreadingthemessageyourresultswillappear andabeeperwillsoundifenabled. Youwillbeaskedtoremovethestrip.Thetestcanbe cancelledatanytimebyeitherremovingthestripor pressingtheCancelbutton. 28 9. Thebloodglucoseresultisavailableonscreenin5 seconds.Theresultswillshowthebloodglucose valueandtheamountithasincreased(+)or decreased()fromthelasttimeyoutested.While youarewaitingforyourresults,apersonalized healthtipwillappearinsteadoftheusualboring countdown. 29 10. Theresultisautomaticallystoredintothedevices memory. NOTE: Lancets are for onetime use only. Use a new, sterilelanceteachtimeyoutest.Testdifferentareason your fingertips to avoid developing calluses. Remove theusedlancetfromthelancingdeviceandfollowyour localdisposalregulationswhereapplicable. NOTE:Iftheerrorscreenappears,itismostlikelydueto thesamplebeingtoosmall.Thesamplehastofillmostof thewell/channelinthewhitepartofthetestingstrip. WARNING:Yourlancingdeviceisforpersonaluseonly.DO NOTshareitwithothers.Sharingthelancingdeviceor lancetscantransmitseriousinfections.Toavoidaccidents, donotstoreusedlancetsinthedeviceaftertestinganddo notloadthelancingdevicewithanewsterilelancetunless readytouse. 30 NOTE:Donotpresstheteststripdirectlyagainsttheskin. Touchtheteststripgentlytotheblooddrop. 11. Afteryourbloodglucoseisdisplayedonthescreen, youcanquicklyandeasilytagyourbloodglucose resultwithimportantinformationasfollows:
MealtimeTags ThefirstscreenthatappearsistheMealtimescreen. Selectbytappingthebuttonandselectingthemealat whichthebloodglucosewastaken.Onceyouhave selectedthemeal,itwillbehighlighted. IfyouselectedanyoftheAftermeals,theAddCarbs willbehighlighted.BytappingAddCarbs,akeypadwill appearwhereyoucanaddthecarbsforthatmeal. Thenumberswillbehighlightedonselectionandwill 31 registerinthecounterbox.Ifyoudonotwanttotagcarbs withyourbloodglucose,justpressNEXTatthebottom rightofthescreen.Youcanalwaysgobackandchange yourselectionbytappingtheBACKbutton. Ifyouuseinsulinandhavesetupyourprofileontheweb portal(seebelow),oronyourInTouchTM(insettings),you canlogbothyourCarbsandyourInsulindose. Immediatelyfollowingyourresults,thescreenwillshow AddCarbs/Medswhichwilltakeyoutoascreenwhere youcanaddyourmealtimeCarbsandInsulindose,by pressingCarbsorInsulinatthetopofthedisplay.The keypadwillletyoutypeinyourrecordsforCarbsand Insulin. Feeling Sometimesyoumaywanttoquicklyaddsomeother helpfulnotestoyourbloodglucosedataincludinghow 32 youfeel,whetheryourbloodglucosereadingfollows exercise,orwhetheritiswithorwithoutmedication. Theseselectionsareallatyourfingertipsandcanbe chosenfromapreselectedlistontheInTouch displayscreen(yourwebsitewillgiveyouadditional opportunitiestoaddnotes). Ifyouarefeelingfine,forexample,justtaptorecord thisaspartofthedatathatisautomaticallyrecorded inyourlogbookandtransmittedtoyourhealth account. Thesenotescanbehelpfulforbothyouandyour healthcareprovidertounderstandanypatternsthat mightarisewithmealtimes,medications,exercise,or otherfactors. 33 ChangingYourSelections 12. Whenyouarefinishedandthetagsarecompleted, youwillbeaskedtoconfirmtheinformationbefore itissentsecurelytoyourhealthaccount. Beforetransmittingthedata,youcanalwaysgo backandchangeyourpreviousselectionsby pressingtheBackbuttonandreselectingfromthe quickaddmenus. 13. Ifthereadingishighorlow,orifthereisanother issue,youmaybepromptedtotestagain. 14. Yourresultsandtagscanbefoundinyourhealth accountwithinaminute;fromthere,youcansend datadirectlytoyourcoachorhealthcareteam. 15. Youcanalsoviewyourresultsonlineat:
www.InTouch.eoshealth.com 34 16. Whenyourresultshavebeensuccessfully transmitted,youwillreceiveatiporpersonal messagefromyourcoachorhealthcareteam. 35 IfDataTransmissionIsUnsuccessful Ifthereareonlyoneortwobarsofwirelesssignal strengthonyourdevice,itmayresultinunreliable transmissionorreceptionofyourdata.Thesignal strengthindicatorislocatedatthetopoftheIn Touchscreen. Ifthedevicecannotcommunicatewithyoursecure healthportal,thefollowingmessagewillappear:
Nodataconnection,datawillbestoredand transmittedassoonasasecureconnectionis detected. 36 Inthiscase,yourresultswillbestoredand automaticallytransmittedonceasufficientsignalis acquired.Youdonotneedtodoanythingsincethiswill happenautomaticallyonceareliablesignalis obtained. Ifthedatatransferfails,InTouchdisplaystheblood glucoseonitsscreenjustlikeanyotherglucosemeter. Theresultswillalsobestoredinthememoryandcan bereviewedintheTrendssection. IMPORTANT:Ifyourbloodglucoselevelisabove600 mg/dLorbelow20mg/dL,recheckyourbloodglucose immediatelyusinganewteststrip. DONOTrecheckonyourpalmorforearmbutusing yourfingertips.Ifyoustillreceivethesamevalue,call yourdoctororhealthcareprofessionalimmediately. 37 Chapter6WhatDoYourResultsMean?
Yourbloodglucosevaluewillvaryaccordingtoyour foodintake,yourmedication,yourgeneralhealth,your stresslevels,andyourlevelofphysicalactivity.Togive youanidea,theidealrangesforpeoplewithout diabetesareasfollows:
70to100mg/dLbeforemeals,and 70to140mg/dLaftermeals. BloodSugar Testresultsgreaterthan250mg/dLmaymeanhigh bloodsugar(hyperglycemia). Testresultslowerthan60mg/dLmaymeanlowblood sugar(hypoglycemia). HighOrLowReadings IfyourInTouchdisplaysresultsthataremorethan 250mg/dLorbelow50mg/dLANDyoufeelill,treat yourdiabetesaccordingtoyourdoctorsinstructions. IfyourInTouchdisplaysresultsthataremorethan 250mg/dLorbelow50mg/dLandyouDONOTfeelill:
38 TestyourInTouchwithacontrolsolution(see section4). Washyourhands,drythoroughly,andtestagain usingyourngertip. Ifyoustillgetahighorlowreading,youshouldcontact yourdoctor. References AmericanDiabetesAssociation StandardsofMedicalCareinDiabetes2008. DiabetesCare2008;31:S12S54. 39 Chapter7Forearm&PalmTesting InTouchallowsyoutocheckyourbloodglucoseon alternativesiteswiththesameaccuracyasonyour fingertips.TheInTouchreducesthepainofblood glucosemonitoringsignificantlybyrequiringonly0.6 Lofbloodsample. HowToTest 1. Selecttheforearmtestsiteinthehighlighted areaasshowninthediagrambelowor, alternatively,selectthepalmheelorpalmside testsite. 2. Attachtheclearcapto thelancingdevice. Pressandholdthe lancingdevice FIRMLYagainstthe forearmorpalm. 3. Continuetohold FIRMLYandpressthe releasebuttonto lancethearea. 40 4. Continuetoholdthedevice,pressingFIRMLYuntila fullblooddropforms.Theclearcapallowsyouto seetheblooddrop. 5. Applytheblooddroptotheedgeoftheteststripso thatthebloodisdrawnintothestrip. 6. Holdthemonitortotheblooddropuntilyouheara shortbeeporuntilyouseethemonitorbeginto countdown. NOTE:Thebloodonthestripshouldlooksimilartothe redbloodyouareaccustomedtoseeingwhenyoutest yourfinger.Ifthesamplelooksclear,pink,orlightin color,retestwithafingertipsample. 7. Yourbloodglucosetestresultisdisplayedonthe screenandstored. Limitations&Considerations Somepeoplechecktheirbloodglucoseatsitesother thanthefingerbecauseitisgenerallylesspainful. However,therearecircumstanceswhentheseother sitescangivedifferentresultstothefinger. Resultsfromtheforearmmaybedifferentfrom fingertipresultswhenglucoselevelsarechanging rapidly,e.g.afterameal,aftertakinginsulin,or duringorafterexercise.Onlyusefingerorpalm checksduringthesetimes. 41 CAUTION:Alwaysseektheadviceofyourdoctoror healthcareprofessionalbeforechoosingtouse forearmandpalmsites.Bruisingmayoccurwith forearmandpalmtesting. Don'tUseForearmChecking Foratleast2hoursafteryouhaveeatenor injectedinsulin. Ifyouhaverecentlyexercised. Ifyouthinkthatyourbloodglucoseislow. Ifyouthinkthatyourbloodglucosemaybe changingrapidly(e.g.afterameal,aftertaking insulin,orduringorafterexercise). Ifyouareunawareofsymptomswhenyourblood glucoseislow(hypoglycemic). Ifyourforearmresultsdonotmatchthewayyou feel.Inthiscase,recheckusingyourfingerorpalm. ForearmCheckingMightNotBeAppropriate Ifyouareill. Ifyouareunderextrastress. Ifyouroutinelyhavewidelyfluctuatingblood glucosevaluesthatareoftenlow(hypoglycemic). Ifvaluesfromthepalmsamplewereshowntobe equivalenttovaluesfromthefingersamples. 42 Chapter8ViewingResultsandTrends YourInTouchstores500recordsinitsonboard memory.Thisgivesyouaconvenientviewofwhats beenhappening.Thereisaquickandeasywayto reviewyourresults:
TaptheTrendsicononthe homescreen. UnderTrends,youcanview yourLogbooks,Mealtime Values,Trends,Patterns&
Statistics,andActivity. YoucanalsogetaSnapshot Summaryofhealthfrom yoursecurepersonalhealth account. Yourpersonalhealthresultsandsomehelpful personalizedadvicebasedonyourreadingscanbe foundinyourpersonalhealthaccountat www.InTouch.eoshealth.com. 43 Logbook YourLogbookisanoverviewofyourrecentrecords.It willshowyouresultsfromthelast7days.Youwillsee theDayandMealtime,(BeforeandAfter)in relationtoyourbloodglucose.Themostrecent7day valueswillappearfirst. Togetmoredetail,youcantapontheDaybuttonto displayanexpandedviewfortheselectedday. Theappleindicateswhetheritisbefore(whole)or afterameal(eaten). MealtimeValues TogetaQuickViewofthemealtimevalues,InTouch willdisplaybloodglucosevaluesandtrendsfor Breakfast,Lunch,Dinner,orBedtime(Snack)intabular orgraphicformforeachofthemeals. 44 BytappingtheB,L,orDonthetopbarofyour Logbook,youcanviewthemealtimevaluesforthe weekorforaperiodofupto30days. Highorlowvaluesarehighlightedinredandthose intermediateorborderlinevaluesinyellow. CarbsandadditionalNotes(e.g.Feelings)willbe displayedinthesetables. TappingontheDaybuttoninthefarlefthandcolumn willdisplayanexpandedviewoftheMealtime Logbook. 45 Patterns&Stats InTouchalsoprovidesQuickViewsofpatternsand statistics,displaying(7,14,and30day)averages,high, lows,percentagevariability,andpercentageofyour bloodglucosevalueswithinyoursettargets. YoucanviewforALL,B,L,D(Breakfast,Lunch,and Dinner),andwhetherbefore(apple)orafter(eaten apple). TappingtheB,L,orDatthetopofthebardisplaysthe breakdownforthatmealtimeandshowsanaverage over7,14,30,or90daystoidentifyanytrends. 46 ItisalsopossibletoviewyourHighorLowvalues,in totaloratspecificmealtimes,togetherwithother notes,toseeiftherearepatternsthataffectyour bloodglucoselevel. 47 StepsandCalories YourInTouchautomaticallyrecordsyourstepsand thenumberofcaloriesyouburnedtoyourpersonal healthaccount. Yourresultsfortheweekcanbedisplayedbytapping theActivitybutton. Likeyourbloodglucoseresults,youractivityresultsare displayedbytheweek.Youcantaponthedaytoget anexpandedviewaswellasthestepsforthatday
(DailySteps). 48 49 SnapshotSummary InTouchwillprovideanupdated30daysnapshotof yourhealthmetricsincludingbloodglucose,glucose goals,runningHb1Ac,Variance(howmuchyourblood glucosevaluefluctuatesinthe30dayperiod),Steps, andNetCaloriesgained(+)orlost(). 50 Chapter9YourMessages Messages YourInTouchalsoprovidestwowaymessagingand hastheabilitytoretrieveandstoremessagesand personalizedtips.TheMessageIcononthehome screenwilldisplayhowmanynewandunread messagesyouhavewaitinginyourInbox. Toviewyourmessages,taptheMessageicononthe Homepage.Messagesincludereminders,healthtips, andimportantcommunicationsfromyourhealth team. Youcanretrievemessages placedinyouraccountfrom yourhealthteam,your coach,oryourdoctor. Oneoftheinnovative featuresofIntouchisthat youwillbenotifiedwhenyou areclosetorunningoutof bloodglucosestrips. Wemakeiteasy:whenyou areabout5daysawayfromrunningout,theautomatic messagingwillaskyouifyouwouldliketoreorder. 51 Ifyoudo,thenthesupplieswillbesentdirectlytothe addressyouhaveinyouraccount.Andyouwillbe notifiedthattheyhaveshipped,allonyourInTouch. Thisistheeasiestwaytostaystockedup. Team InTouchTMcansendyourresultsdirectlytoyourTeam:
yourhealthcoach,MD,familymobilephoneoremail. BysimplytappingMyCoachorMyMD,yourpersonal healthrecordwillbefaxedoremailedtothenumber oraddressyouprovidedwhenyouregistered. Forexample,ifyoutapMyMobile,your30,90,and 120daysummarywillbesenttoyourmobilephoneas atextmessageoremail. 52 MyCoach BytappingtheMyCoachiconyoucansendyourresults directlytoyourcoachandsetupacoachingsession. MyMD 53 ByselectingMyMD,youcanshareyourresultswith yourMD.Ifyouhaveplacedyourdoctorsfaxnumber whenyouregisteredoronthewebsite,theresultswill beautomaticallytransmittedtothatnumber. 54 Ifyouhavenotregistered,akeyboardwillappear whereyoucanenteryourdoctorsfaxnumbertosend yourresults.Youonlyhavetoenterthisonlyonceasit willbestoredinyourpersonalhealthaccount. MyFamily MyFamilyenablesyoutoselectamemberofyour familywithwhomyouwanttoshareyourresults.They willgetyourresultsbytextontheirmobilephone, email,orbyatelephonecall.Youandtheycanchoose howtheywanttobestgetyourresults. Thisisidealforcheckinguponkidswhoareinschool sothatmomanddaddonthavetocalltheschoolto gettheresults.Youcanchoosewhenandhowtoshare theinformation,andeverythingissentsecurely. 55 MyMobile MyMobileallowsyoutosendrecordsdirectlyto yourmobilephoneforeasyviewing. NOTE:Whenthemonitormemoryisfull(500test results),theoldestresultwillbedeletedfromtheon boardmemory.YouwontloseanydatabecauseIn TouchTMwillconfirmthattheoldestresultisalready loggedinyoursecureWebhealthaccount. 56 Chapter10YourPersonalWebPortal Yourtestresultsandpersonalinformationarestored securelyinyouronlinehealthaccountandcanbe viewedbyvisiting:
https://www.eoshealth.com/intouch/
LoggingIn YouwillneedtoenteryourUserID(usuallyyouremail address)andthepersonalidentificationnumber(PIN) youspecifiedwhenyoufirstregistered. 57 Dashboard Whenyoulogin,thefirstscreenyouwillseeisyourBG Dashboard,whichwillletyouviewyourresultsfor todayorforthelast7,14,30or90days;youcanalso createaprintout. TheDashboardshowsyouataglanceyouraverage bloodglucoselevelwithinyourchosentimeframe, yourhighestandlowestlevels,howmanystripsyou haveusedandhowwellyouarestickingtoyourtesting routine. MoreDetail Clickingonthedropdownlistsalsoletsyousee:
Whenyouwillneedtoreordermoreteststrips. 58 Yourhealthlog,withtaggedmealreadings. Yourlatestglucosereadings. Mealpatternsandstats. Trends. Averages. YourInTouchmessages. Youronlinehealthaccountalsohaspageswhereyou canseeallyourdata(andfilteritifrequired),change yourclinicalsettings,changeyourprofiledetails,and accessInTouchsupport. 59 Chapter11CheckingYourInTouch TheControlSolutionTest Thecontrolsolutiontestconfirmsthatyourmonitor andteststripsareworkingcorrectly.Acontrolsolution testissimilartoabloodtest,exceptthatyouuseIn TouchControlSolutionandnotabloodsample.You shouldrunacontrolsolutiontest:
Whenyoufirstgetyourmonitorandthenat leastonceaweek. Eachtimeyouopenandbeginusinganewvial ofglucoseteststrips. Ifyouleavetheglucoseteststripvialcapopen foranylengthoftime. Ifthemonitorisdropped,damaged,orexposed toliquids. Ifyouthinkyourtestresultsareinaccurateorif yourtestresultsareinconsistentwithhowyou feel. Tochecktheperformanceofthemonitorand teststrips. NOTE:HighandLowGlucoseControlsarealso recommendedasanadditionalqualitycontrolcheck 60 foryourInTouchmonitoringsystem.Thesecanbe purchasedfromyourdealer. UsingControlSolution UseonlygenuineInTouchControlSolutionto check. Checktheexpirationdateonthecontrolsolution vial.Donotusecontrolsolutionpasttheexpiry dateoryoumaygetinaccurateresults. Thecontrolsolutionwillremainaccuratefor3 monthsafterfirstopening.Discardanyremaining solutionafterthisdate. Storethecontrolsolution,tightlyclosed,atroom temperaturebelow86F(30C). Donotrefrigerateorfreezethecontrolsolution. Shakethecontrolsolutionwellbeforeusingit. CAUTION:TheInTouchTMGlucoseControlSolution rangesprintedontheteststripvialandfoilpouchare forthecontrolsolutiononlyandareusedtotestthe performanceofthemonitorandteststrip. IfyourControlSolutionResultscontinuetofalloutside theprintedrange:
TheInTouchMonitormaynotbeworking properly. Donotusethemonitortotestyourblood. 61 InsidetheUSA,callCustomerServiceat1800945 4355.OutsidetheUSA,contactyoursupplier. CheckingyourInTouchTM 1. PresstheON/OFFbuttononthesideandgoto Settings>Calibrate>Control. 2. Insertastripintothemeter. NOTE:Ifthestripisremovedbeforeyoustart,the screenwillgoblank.Ifacontrolisnotperformed within2minutesofinsertingthestrip,thescreenwill goblank.Tocheck,removeandreplacethestrip, startingfromStep1. 3. Shakethecontrolsolutionvial.Discardonedrop beforeuse.Squeezetheseconddropofcontrol solutionontoaclean,hard,drysurface,i.e.the 62 controlcap. 4. GototheSettingssectionandselectCalibrate>
Control. 63 5. Pickupthemeterwithstripinsertedandtouchthe striptothedropofcontrolsolution. 6. Aqualitycontrolresultisavailableonscreenin5 secondsforglucose. 7. Comparetheresultonthedisplaywiththerange printedonthestripvialorfoilpouch.Iftheresult fallswithintherange,yourmonitorandstripsare workingcorrectly. 64 8. Theresultisautomaticallystoredintothedevices memory,ismarkedandsenttoyourhealthrecord asacontrolsample.Youcanreviewyourcontrols withinyourhealthrecord. ControlSolutionTroubleshooting Outofrangeresultsmaybecausedbythe following:
Anerrormayhaveoccurredwhenperformingthe controltest.Tryanothertestandrememberto followtheinstructionscarefully. Thecontrolsolutionmayhaveexpiredormayhave beencontaminated.Checktheexpirationdateon thecontrolsolutionvial.Controlsolutionisonly goodfor3monthsafteropening.Makesurethe controlsolutionvialisclosedwhennotinuse. 65 Thestripmayhaveexpired.Checktheexpiration dateontheteststripvial. Theteststripmayhavebeendamaged.Thiscanbe causedbyextremetemperaturesorbyleavingthe teststripvialcapopen.Tryanothertestusinga newteststrip. Theremaybeamonitormalfunction.CallTechnical Supportat18009454355(insidetheUSA). OutsidetheUSA,contactyoursupplier. ImportantTips UseonlyInTouchControlSolutionwiththeIn TouchStrips.Otherbrandsofcontrolsolutionor teststripswillproduceinaccurateresults. Alwayschecktheexpirationdate.Donotuse expiredcontrolsolution. Donotfreeze.Storethecontrolsolutionclosedand atroomtemperature. Nevertouchthetipofthecontrolsolutionbottleto theteststrip;thiswillcontaminateallthe remainingsolutioninthebottle. NOTE:Ifthecontrolsolutiontestresultisoutsidethe range(iseitherhigherorlower),yourmonitorandtest stripmaynotbeworkingtogetherproperly.Repeatthe processusinganewteststrip. WARNING:Donotusethemonitorformedical purposesuntilyourcontrolsolutiontestresultsfall withintheappropriaterange. 66 67 Chapter12Maintenance Cleaning TheexterioroftheInTouchMonitorshouldonlybe cleanedanddisinfectedwithDISPATCHHospital CleanerDisinfectantTowelsTM.Thesehavespecial ingredientsthatcleananddisinfectyourInTouchTM. Cleananddisinfectyourmeteratleast1timeperweek usingDISPATCHHospitalCleanerDisinfectant TowelsTM.usingtheprocedurebelow.Liquidsshould notentertheteststripport. 1.DispensetheDISPATCHHospitalCleaner DisinfectantTowelsTMfromitspackageorcontainer. 2.Cleantheoutsideofthemetertoremoveanyblood ordirt. 3.Discardusedtowelinasealedcontainerwhereit willnotbetouchedbyothers. 4.DispenseasecondDISPATCHHospitalCleaner DisinfectantTowelsTMfromitspackageorcontainer. 5.Discardusedtowelinasealedcontainerwhereit willnotbetouchedbyothers. 6.Waitatleastoneminuteandmakesuredeviceis 68 completelyairdriedbeforecheckingyourblood glucosenext. 8.Disinfectthemeterwiththesecondtowelbywiping alloutsidesurfaces. InTouchTMhasbeenvalidatedfor1,825cleaningand disinfectioncyclesoroncethelifetimeofthedevice(5 years)hasbeenreached,whichevercomesfirst. Battery Themonitorispoweredbyarechargeablebattery.If thisbatterybeginstolosecharge,asmalliconwill appearnearthebatterypowericonintheupperleft cornerofthescreentowarnthatthemonitorhas sufficientchargefor20moretests. Continuewithtestingasusual;thebatterywarningwill remainonscreen. 69 WhenchargingusingtheUSBcharger,youwillnotbe abletouseInTouchtodoanychecking.Unplugthe chargerfromthewallbeforechecking.Thedisplay screenwillalsoshowhowInTouchischarging. After20testshavebeenperformed,therewillbe insufficientbatterychargetocontinuetesting,andthe monitorwillnolongeroperate. Ifyounoticesignicantreductioninthedurationof yourmetersoperatingtime,yourmetermayneed replacing.PleasecontactInTouchtechnicalsupport at(888)6664530,oremailsupport@.com. 70 StoringYourInTouch&Strips Yourmeterisadelicateelectronicdevicethatshould behandledwithcare.Severeshock,suchasthat causedbydroppingthemeter,coulddamageit. Themeterandteststripsonlyworkinthetemperature rangeof50Fto104F. Storetheteststripsbetween39Fand86F.Donot freeze.Seetheteststripinstructionsformoredetails. Dontleavethemeterinaplacethatisextremelyhot orextremelycold(e.g.anywherenearaheatsourceor inanextremelyhotorcoldcar). Donotexposethemeterorteststripstohighlevelsof humidity,suchasinthebathroomorkitchen. Immediatelyclosethebottlecaptightlyafterremoving ateststrip. 71 CAUTION:DONOTattempttoopenthemonitorto makeanyrepairs.Yourwarrantyandallclaimswillbe void!Onlyauthorizedservicepersonnelcanrepairthe monitor. Ifyouhaveanyproblemsorquestions,turnyourmeter offandcontactInTouch.InsidetheUSA,call CustomerServiceat18009454355.OutsidetheUSA, contactyoursupplier. SupportisavailableMondaythroughFriday,9AM 5PMEST. 72 Chapter13SettingsOptions Help YourInTouchcomeswithaninteractiveHelpmenu, digitalFAQsandanabbreviatedUsersManual.This meansyoucangethelpdirectlyfromyourdevice, whereveryouare. About Theaboutmenucontainsimportantinformation aboutyourInTouchdeviceincludingtheversion number,transmittingmoduleIDnumber,andthe 73 wirelesscard,allofwhichcanbeusedto troubleshootanyissuesyoumighthave. AirplaneMode TurningontheAirplaneModedisablesyourcellular networkaccess,andyouwillnotbeabletotransmit yourreadingswhileitisturnedon.Thisisusefulifyou aretakingofforlandingduringaflight. Yourmetersclockwill,however,continuetowork properlyinthismodeandwillresetwhenAirplane Modeisturnedoff.YoucanstilluseInTouchjustlike anyotherglucosemeterandwhenyouaccessthe cellularnetworkyourvalueswillbeautomatically transmittedtoyourhealthaccount. 74 Meds InTouchTMhasabuiltininsulinlogbooktohelp yourecordyourinsulindose.Todothis,simplytap theMedsandsetittoInsulinY/N,andyourIn Touchwillpromptyou,shouldyouwish,torecord yourinsulindoseatspecifictimes. ActivityMonitorSettings Thesesettingsallowyoutotailoryourstrideandstep information,asshort,medium,orlongstrides.Thiscan helpyougetmoreaccurateresultswhichreflectyour bodyshape. 75 Reminders YourInTouchhasareminderfunctionthatwillsound orprovideamessageonthescreen.Itispresetto On.Thistellsyouwhenenoughbloodisappliedto thetstrip,whencheckingiscompleted,whenyou haveamessagewaiting;ifenabled,italsopromptsyou tocarryoutotherstepsusingyourmonitor. You can create up to three reminders to tell you whentocheckortakemedications.Youcansetthe timesbytappingthetimeandtheAMorPM,and alsosetthedayoftheweek. CalibrateControl Thisfunctionallowsyoutotestthemeterandtest stripfunctionsusingacontrolsolutiontomakesure thattheyareworkingproperly. 76 77 78 Chapter14Troubleshooting IssuesWithTests If your device does not begin checking after you haveinsertedabloodsample,youshouldcheckif:
Theteststripisupsidedownorisnotinserted fully. Thebatteryisdead. Youhavetakenenoughbloodtosample. YourInTouchhasautomaticallyturneditself off. Theteststripmaybedamaged. YourInTouchmaynotbeworkingproperly. BasicTroubleshooting 1. Inserttheteststripcorrectlywiththenameand whitetipfacingupandout.Ifyouarestill havingissueswithtests:
2. Repeatthetestwithanewteststrip. 79 After 3 attempts, call 18009454355 (inside the USA).OutsidetheUSA,contactyoursupplier. ErrorMessages Intheeventyourdeviceexperiencesanerror,you willseethefollowingscreenalongwithanerror message. ErrorMessage:MeterFailure Whatitmeans:Aswithanycomputerdevice, sometimesthemetermayneedtoberestarted. Actiontotake:RestartmeterandcontactIn Touchsupportiftheproblemcontinues.Turn yourmeteroffbeforecallingInTouchon1800 9454355 ErrorMessage:UsedStripInserted Whatitmeans:Yourteststripmaybeusedor damaged. Actiontotake:Repeatthetestwithanewtest strip.Remembertoaddthesampleonlywhenyou seethepromptonthedisplayscreen.Ifyoubelieve thatyouhavereceivedadamagedteststrip,return ittoInTouchforafreereplacement. ErrorMessage:NotEnoughBlood 80 Whatitmeans:Thereisnotenoughbloodortoo muchbloodorcontrolsolutionontheteststripto giveareliablereading. Actiontotake:Removetheteststripandrepeat thetestwithanewteststrip. ErrorMessage:Temp.TooLow/Temp.TooHigh Whatitmeans:Themeteristoohotortoocold. Actiontotake:Movethemeterintoanareathatis between50Fand104F. IMPORTANT:Afterreceivingthiserror,allowthe metertobeatroomtemperatureforatleast30 minutesbeforetestingbloodorcontrolsolution. CommunicationErrors ErrorMessage:"Nodataconnection,datawillbe stored."
Whatitmeans:Themetercannotndacellular connection. Actiontotake:SeeCommunicationErrorsbelow. Ifyouarehavingtroubleuploadingyourresultsto InTouch,youmaywanttotrythefollowing:
windowforbettercellularreception. Ifyouaretestingindoors,moveclosertoa 81 Trytestingoutdoors. Checktoseeifthereiscellularcoverageinyour area.Twobarsorlessofwirelesssignalstrength mayresultinunreliabletransmissionandreception ofdata. Restartthemeter. GettingSupport Ifyoustillcan'tresolveyourproblem,turnyour meteroffandcontactourInTouchtechnical supporton:
18009454355 support@intouch.eoshealth.com 82 Chapter15Specificationsand Limitations Specifications TestMeasuredBloodGlucose GlucoseMethodologyGlucoseoxidasebiosensor GlucoseTestResultsmg/dL(Plasmavalues) Sample type Capillary whole blood Glucose Test range20to600mg/dL AcceptableHematocritrange25%to60%
LengthofTest5seconds(Glu),10seconds(Ket) TestStripVolumes0.6L(Glu) OperatingRanges Temperature:57to104F(14to40C) Humidity:10%to90%relativehumidity Altitude:upto10,000ft(3000m) Weight:2.65oz(75g) Size3.6x2.3x0.9in(91.4x58.4x22.9mm) Monitordatastorage:500results Electrical&PowerRatings ElectricalSpecifications:
3.7VLiPolymerBattery1100mAh Maximumcurrent(Battery):650mApeak 83 Maximumpower(Battery):2.4Wpeak Maximumcurrent(USBinput,charging):1Acontinuous USBcharginginput:5V1A GlucoseTestImprecision 6%or5.4mg/dL(whicheverisgreater) Environmental Thestoragetemperaturerangeforthemonitor:
13Fto115F(25Cto46C). The storage temperature range for the test strips:59Fto86F(15Cto30C). The monitor operational temperature range:
57Fto104F(14Cto40C). The relative humidity range: 10% to 90% non condensing. Limitations Theteststripsgiveaccurateresultswhenthefollowing limitationsareobserved:
Theteststripsshouldnotbeusedtodiagnose diabetes,DKA,ortotestnewborns. Eachteststripisforasingletestonly.Donotreuse thestrips.Useanew,sterileInTouchteststrip eachtimeyoutest. 84 Yourteststripsareforpersonaluseonly.Donot sharethemwithanypeople,includingrelatives. Useonlyfreshcapillarywholeblood.Donotuse serumorplasma. Thereisnoeffectonbloodglucoseforaltitudesup to10,000feet(3000meters)abovesealevel. RefertotheOwnersGuideforoperating temperaturerangeforthemonitor. Extremesinhumidity(higherthan90%andlower than10%)mayaffectresults. TheInTouchTestStripsarecalibratedagainst plasma. Theanticoagulantsodiumandlithiumheparinmay beused.EDTAisnotrecommendedforusewithIn TouchTMTestStrips. Interferencesforelevatedlevelsof acetaminophen,tolazamide,uricacid,bilirubin, ephedrine,andmethyldopamayaffectresults. Glucosetestresultsmaybefalselylowifthe patientisseverelydehydrated. Criticallyillpatientsshouldnotbetestedwiththe InTouchGlobalGlucometer. 85 Chapter16WarrantyandCompliance YourInTouchisguaranteedtobefreeofmaterial andworkmanshipdefectsfor3yearsfromthedateof purchase(exceptasnotedbelow).Ifatanytimeduring thefirst3yearsafterpurchase,yourInTouchdoes notworkforanyreason(otherthanasdescribed below),itwillbereplacedwithanewmonitorora substantialequivalent,freeofcharge. LimitationsOnWarranty Thiswarrantyissubjecttothefollowingexceptions andlimitations:
Thiswarrantyisapplicableonlytotheoriginalpurchaser. Thiswarrantydoesnotapplytounitswhichmalfunctionor aredamagedduetoobviousabuse,misuse,alteration, neglect,unauthorizedmaintenanceorfailuretooperate meterinaccordancewithinstructions. WehavenoknowledgeoftheperformanceoftheInTouch MonitorwhenusedwithteststripsotherthanNovaTest Strips.Therefore,wemakenowarrantyastothe performanceoftheInTouchwhenusedwithanyteststrips otherthanNovaTestStrips. Thereisnootherexpresswarrantyforthisproduct.The optionofreplacement,describedabove,isthewarrantors onlyobligationunderthiswarranty. 86 ForWarrantyService TheoriginalpurchasermustcontactCustomerService at18009454355ifintheUSA.OutsidetheUSA, contactyoursupplier. FCCInterferenceStatement Thisequipmenthasbeentestedandfoundtocomply withthelimitsforaClassBdigitaldevice,pursuantto Part15oftheFCCRules.Theselimitsaredesignedto providereasonableprotectionagainstharmful interferenceinaresidentialinstallation. Usingthisequipmentgenerates,uses,andcanradiate radiofrequencyenergyand,ifnotinstalledandusedin accordancewiththeinstructions,maycauseharmful interferencetoradiocommunications. However,thereisnoguaranteethatinterferencewill notoccurinaparticularinstallation.Ifthisequipment doescauseharmfulinterferencetoradioortelevision reception,whichcanbedeterminedbyturningthe equipmentoffandon,theuserisencouragedtotryto correcttheinterferencebyoneofthefollowing measures:
Reorientorrelocatethereceivingantenna. Increasetheseparationbetweentheequipment andreceiver. 87 Connecttheequipmentintoanoutletonacircuit differentfromthattowhichthereceiveris connected. Consultthedealeroranexperiencedradio/TV technicianforhelp. FCCCaution Anychangesormodicationsnotexpresslyapproved bythepartyresponsibleforcompliancecouldvoidthe usersauthoritytooperatethisequipment. FCCRadiationExposureStatement ThisequipmentcomplieswithFCCRadiationExposure Limitsforanuncontrolledenvironment. Thistransmittermustnotbecolocatedwithor operatinginconjunctionwithanyotherantennaor transmitter. PrivacyPolicy AsthemanufacturerofInTouch,EosHealthis committedtousingyourpersonalinformationrespon siblyandincompliancewiththelaw.Wepledgethat wewillnotshareorsellyourpersonalinformation withmarketersorthirdparties.Theinformationyou voluntarilysharewithuswillonlybeusedtohelpus provideabetterserviceforyouinthefuture. 88 89
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2013-12-15 | 1850.2 ~ 1909.8 | PCB - PCS Licensed Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2013-12-15
|
||||
1 | Applicant's complete, legal business name |
Livongo Health, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0023086168
|
||||
1 | Physical Address |
150 W. Evelyn Ave
|
||||
1 |
Mountain View, California 94041
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
T******@babt.com
|
||||
1 | TCB Scope |
B1: Commercial mobile radio services equipment in the following 47 CFR Parts 20, 22 (cellular), 24,25 (below 3 GHz) & 27
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AA92
|
||||
1 | Equipment Product Code |
3614-04
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
R******** B********
|
||||
1 | Title |
Engineering Program Manager
|
||||
1 | Telephone Number |
866.4********
|
||||
1 | Fax Number |
866.4********
|
||||
1 |
c******@livongo.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 06/13/2014 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | PCB - PCS Licensed Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | In Touch Blood Glucose Monitoring System | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power listed is conducted. Device must operate with a maximum duty factor not exceeding that described in this filing. The duty factor must be implemented in factory firmware. The antenna(s) used for this transmitter must not be co-located or operating in conjunction with any other antenna or transmitter except in accordance with FCC multi-transmitter evaluation procedures. This device contains functions that are not operational in U.S. Territories. This filing is only applicable for U.S. operations. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
UL VS Ltd
|
||||
1 | Name |
D**** C******
|
||||
1 | Telephone Number |
00-44********
|
||||
1 | Fax Number |
00-44********
|
||||
1 |
d******@ul.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 22H | 824.2 | 848.8 | 1.74 | 15 Hz | 300KGXW | ||||||||||||||||||||||||||||||||||
1 | 2 | 24E | 1850.2 | 1909.8 | 1 | 15 Hz | 300KGXW |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC