eoshealth IN TOUCH User manual

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INTOUCH™BLOODGLUCOSE
MONITORINGSYSTEM
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OWNER’SMANUAL
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V1.6

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CONTENTS
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Chapter1–YourInTouch™..................................................5
YourInTouch™5
RegisterYourInTouch™6
ContactUs7
Important–StayingSafe7
UsingThisUserGuide9
Chapter2–Overview........................................................  10
IndicationsforUse11
YourDoctor13
Chapter3–Components.....................................................14
InTouch™14
GlucoseTestStrips14
ImportantInTouch™GlucoseTestStripInformation15
LancingDevice16
ControlSolution18
Chapter4–GettingStarted................................................19
TurningOnandSettingupyourInTouch™19
YourInTouch™Monitor22
TheDisplayScreen24
Chapter5–CheckingYourBloodGlucose..........................25
BeforeTesting25
SafetyTips25
HowToTest26
MealtimeTags31
Feeling32
ChangingYourSelections34
IfDataTransmissionIsUnsuccessful36
Chapter6‐WhatDoYourResultsMean?...........................38
BloodSugar38
HighOrLowReadings38
References39
Chapter7–ForearmorPalmTesting..................................40

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HowtoTest40
Limitations&Considerations41
Chapter8–ViewingResultsandTrends.............................43
Logbook44
MealtimeValues44
Patterns&Stats46
StepsandCalories48
SnapshotSummary50
Chapter9–YourMessages.................................................51
Messages51
Team52
MyCoach53
MyMD53
MyFamily55
MyMobile56
Chapter10–YourPersonalWebPortal..............................57
LoggingIn57
Dashboard58
MoreDetail58
Chapter11–CheckingyourInTouch™...............................60
TheControlSolutionTest60
UsingControlSolution61
ControlSolutionTroubleshooting65
ImportantTips66
Chapter12–Maintenance..................................................68
Cleaning68
Battery69
StoringYourInTouch™&TestStrips71
Chapter13–SettingsOptions.............................................73
Help73
AirplaneMode73
ActivityMonitorSettings75
Reminders76
CalibrateControl76
About78
Chapter14‐Troubleshooting.............................................79
IssuesWithTests79
BasicTroubleshooting79
ErrorMessages80
CommunicationErrors81

4
GettingSupport82
Chapter15–SpecificationsandLimitations.......................83
Specifications83
OperatingRanges83
GlucoseTestImprecision83
Environmental84
Limitations84
Chapter16–WarrantyandCompliance.............................86
LimitationsOnWarranty86
ForWarrantyService87
FCCInterferenceStatement87
FCCCaution88
FCCRadiationExposureStatement88
PrivacyPolicy88
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USPatentNo.7,935,307,8,066,640,6,837,976,6,942,770,andotherUSand
foreignpatentspending.InTouch™isatrademarkofEosHealth,Inc.Copyright
2013EosHealth,Inc.09/10/2013v1.1

5
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Chapter1–YourInTouch™
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ThankyouforchoosingInTouchTMyourgatewayto
bettermanagementofyourdiabetes.YournewIn
TouchTMsystemwillmonitoryourglucoseandyour
dailyphysicalactivitytohelpyouleadahealthierlife.
Thisuserguidehasimportantinformationonyournew
systemandhowitworks.Pleasereaditcarefully
beforeusingInTouch™,itwillhelpyoumakethemost
ofyournewInTouch™,
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YourInTouch™
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YourInTouch™iseasytouse.Ithasacolortouch
screendisplaywhichwillshowyourbloodglucose,
viewtrends,sharewithyourhealthcareteam,and
viewandretrievepersonalizedmessages.
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6
Itgivesaccurateglucosetestresultsinjust5
secondsusingaverysmallbloodsample.Thissmall
sampleallowsyoutouseathinnerlancetbecause
notasmuchbloodisneededtodoaglucosetest.
It’salotlesspainful.
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InTouch™hasamemorythatstoresyourglucoseand
activityresults.Italsoautomaticallysendsallyour
datadirectlyandsecurelytoyourpersonalizedhealth
accountwirelessly.Youcanalsochoosetosendyour
resultstoyourhealthcareteamandreceive
personalizedadvicetohelpyou,yourcoach,andyour
healthcareprofessionaltomanageyourdiabetes.
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Itevenletsyouknowwhenyouarerunningoutoftest
stripsandneedtoreorder.Butremember,InTouch™
isnotintendedtoprovideautomatedtreatment
guidanceordecisions,norisitasubstituteforyour
professionalhealthcareprovider.It’saguideanda
helper.
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RegisterYourInTouch™
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Beforeyougetstarted,pleasefillouttheWarranty
Registrationcardincludedinyourkitandmailthe
cardbacktotheaddressprintedonthecard,or
completetheWarrantyRegistrationonlineat:
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www.InTouch.eoshealth.com
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Weusetheinformationcollectedtoimproveour
service.
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ContactUs
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InTouch™ismadebyEosHealth,Inc.
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2800PostOakBoulevard,
4100Houston,Texas77056
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InsidetheUSA,pleasecallCustomerServicetoll‐
freeat1‐800‐945‐4355orvisitourwebsiteat:
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www.InTouch.eoshealth.com
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OutsidetheUSA,pleasecontactyoursupplierfor
support.
Important–StayingSafe
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Pleasetakeamomenttoreadthroughthis
importantsafetyinformation.Remember,thisis
amedicaldeviceanditneedstobetreatedwith
respect.
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TheInTouch™BloodGlucoseMonitoringSystem
andlancingdevicemustonlybeusedbyone
person.Forsafetyreasons,donotshareitwith
anyone,includingyourfamilymembers.
Manypartsofyourdevicecomeintocontactwith
yourblood.Kitpartscanpotentiallytransmit
infectiousdiseases,evenafterbeingcleanedand
disinfected.

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Alwayswashyourhandsthoroughlywithsoapand
wateranddrywellafterhandlingthemeter,test
strips,oryourlancingdevice.
Alwaysconsultyourdiabeteshealthcare
professionalandfollowhisorherguidanceabout
yourbloodglucosemonitoringroutine.
Therecommendationsinthismanualapplytoall
bloodglucosemonitorsandaresupportedbythe
AmericanAssociationofDiabetesEducators
(AADE),theAmericanDiabetesAssociation(ADA),
theUSFoodandDrugAdministration(FDA),and
theAdvancedMedicalTechnologyAssociation
(AdvaMed).
Ifthisdeviceisusedinamannernotspecifiedby
themanufacturer,theprotectionprovidedbyit
againsthazardsmaybeimpaired.
TheInTouchGlucoseMonitoringSystemis
deliveredfullyassembledandrequiresno
additionalassembly.
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UsingThisOwner’sManual

Wehaveincludedsomehelpfuladditionstothisuser
manual.Theseare:

NOTES‐helpfulinformationfordaytodayuse.

CAUTIONS‐importanttipsonprotectingyour
glucometer.
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WARNINGS‐crucialinformationthatwillhelpyouuse
yourglucometersafelyandcrucialinformationabout
therisksofreceivinginaccuratereadings.
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10
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Chapter2–Overview
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IndicationsforUse
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TheEosHealth,Inc.InTouch™BloodGlucose
MonitoringSystem(alsoknownasInTouch™)uses
anelectrochemicalenzymaticassayforthe
quantitativedetectionofglucoseinfreshcapillary
wholebloodfromthefingertip,forearm,andpalm
bypeoplewithdiabetesathomeasanaidin
monitoringtheeffectivenessofdiabetescontrol
programs.Fingertip,forearmandpalmtestingsites
shouldbeusedalternatelyonlywhenbloodglucose
levelisnotchangingrapidly.

TheInTouch™BloodGlucoseMonitoringSystemis
ahandhelddevicethatiscomposedofablood
glucosemeter,pedometer,andGSMcellularradio.
TheInTouchBlood™BloodGlucoseMonitoring
SystemmakesuseofitsGSMradiototransmit
glucometerandpedometerdatabacktoaserver
andreceiveinformationfordisplayinresponse.
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TheInTouch™BloodGlucoseMonitoringSystemis
intendedtobeusedbyasinglepatientandshould
notbeshared.Itisforinvitrodiagnosticuseonly.
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•Thisdeviceisnotindicatedforthediagnosisor
screeningofdiabetes.

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•Alternativesitetestingcanbeusedonlyduring
steady‐statebloodglucoseconditions.
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•Alternativesitetesting(AST)shouldnotbeused
tocalibratecontinuousglucosemonitors(CGMs)
norforuseininsulindosecalculations.
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•TheInTouchTMBloodGlucoseMonitoringSystem
andStripsaretobeusedwiththeInTouch™Blood
GlucoseMonitoringSystem;itmeasuresglucosein
capillarywholebloodfromthefingertip,forearm
andpalm.

•ForInVitroDiagnosticUse

YourInTouch™BloodGlucoseMonitoringSystem
measurestheglucoseinyourbloodandalso
measuresyourlevelofphysicalactivity.Thinkofit
likeahealthcoachwhocanhelpyoufeelyourbest.

YoucanuseInTouch™athome,orinclinical
settingstohelpyouwiththemanagementand
treatmentofyourdiabetes.

Pleasenotethatthisdeviceisnotintendedtobe
usedfordiagnosisorscreeningfordiabetes
mellitusandshouldnotbeusedwithnewlyborn
babies.

YourInTouch™takesglucosemeasurementsfrom
smallbloodsamplestakenfromyourfingertip,
forearm,orpalm.

Pleasenote:

12

InTouch™mustonlybeusedoutsidethebody(in
vitrodiagnosticuse).
ItshouldonlybeusedwithInTouch™blood
glucoseteststripsandInTouch™controlsolutions.
Itshouldonlybeusedfortestingglucose(sugar)
withfreshcapillarywholebloodsamples.
ItshouldNOTbeusedtodiagnoseDKAortotest
newborns.
ItshouldNOTbestoredintherefrigeratororinthe
car.

WARNINGS:

1. YourInTouch™containssmallparts.Keepitoutof
thereachofsmallchildrenandpets.


2. Ifyouhavehypoglycemiaunawareness,ablood
glucosemonitoriscriticaltoyourcare.Sinceany
monitormayfail,break,orbemisplaced,you
shouldalwayshaveabackupmonitor.

3. Bloodsamplesandbloodproductsarepotential
sourcesofhepatitisandotherinfectiousdiseases.
Handleallpartsofyourdevicewithcare.Wear
gloveswhenperformingmeasurementsonanother
person.Anyitemsthatareusedtomeasureglucose
liketeststrips,lancets,andalcoholswabs,mustbe
disposedofsafelyinaccordancewithlocal
regulationstoavoidtheriskofinfection.


13

YourDoctor

PleaseusyourInTouch™withcare.Ifyouexperience
symptomsthatarenotconsistentwithyourblood
glucosetestresults,andyouhavefollowedallthe
instructionsdescribedinthisUser’sGuide,consult
yourdoctororhealthcareprofessionalimmediately.It
isalwaysbettertobesafe.

14

Chapter3–Components

InTouch™

Youhaveeverythingyouwillneedinyourbox.Your
newInTouch™devicewillbereadytogoandwill
alreadybepartlycharged.Tochargeitfully,youwill
needtoplugitinovernight.Undernormaloperating
andbloodglucosemonitoringconditions,thecharge
shouldlastforseveralweeks.
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Youwillalsofindthefollowing:
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InTouch™bloodglucoseteststrips(10).
Lancingdeviceandlancets.
Control(Normal)solution(1bottle).
QuickStartGuide.
ACchargerandUSBcord.
Warrantycard.
Carryingcase(oracoupontoredeemoneofyour
choice).
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GlucoseTestStrips
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TheInTouch™GlucoseTestStripsaredesignedforuse
withyourInTouch™Monitoronly.Useeachteststrip

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onlyonce,andthendiscardit.DONOTreapplyblood
totheteststrip.Thisisveryimportant.
Theycomeinavarietyofcolorstohelpyoukeeptrack
ofwhichyouhaveused,buttheyallgiveidentical
results.Theycomeinvialsandalsoasindividually
sealedpackageswithasingleteststrip.
InTouch™GlucoseTestStripsrequireonlyaverysmall
bloodvolume(0.6µLforglucose)andautomatically
drawbloodintothetestareaofthestrip.Theycanbe
handledwithclean,dryhandswithoutaffectingthe
readings.Theyareveryconvenientwhetheryoutestat
homeoronthego.
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ImportantBloodGlucoseTestStripInformation
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Pleaseremember:
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UseonlyInTouch™BloodGlucoseTestStripswhen
testingforglucose.
Removetheteststripfromthevial/foilonlywhen
readytotest.
Storetheteststrippackageinacool,dryplace
below86°F(30°C).Donotrefrigerateorfreeze.

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Donotstoretheteststripsnearheatormoisture.
Storetheteststripsintheiroriginalpackagingonly.
Afterremovingaglucoseteststripfromthevial,
immediatelyreplacethecapandclosethevial
tightly.
Donotuseteststripsbeyondtheexpirationdate
printedonthepackageasthismaycause
inaccurateresults.
Teststripsshouldonlybestoredfor3monthsafter
opening.Discardanyremainingteststripsafterthis
date.
Donottamperwiththeteststrips.
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WARNING:Theteststripvialsandpackagingcontain
smallparts.Keepawayfromchildrenandpets.
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LancingDevice
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Thediagrambelowshowsyourlancingdevice.Thisis
thepartoftheInTouch™whichtakesthesample.
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Touseit,youshould:
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1.Removetheendcap(A,topleft)bygentlypushing
downandawayfromthelancingdevice.

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2.Insertthelancet(B)firmlyintothelancetholder
untilitcomestoastop.
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3.Removetheprotectivelancetcover(C)byholding
thelancingdevicefirmly.Twistandpulloffthelancet
covertoexposethetip.
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DONOTTOUCHTHELANCETTIP.
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4.Replacetheendcapbysnappingitbackontothe
lancingdevice.
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5.Selecttheskinpenetrationdepthbyturningthe
depthselector(F)untilthedesirednumbercanbe
seeninthedepthselectionwindow.Thelancing
deviceoffersfivelevels:1forsoftskin;2‐3for
averageskin,and4‐5forthickorcallousedskin.
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6.Pullbackonthelancingdeviceuntilitcomestoa
stop.Thecockingmechanismwillreturntoits
originalpositionuponrelease.
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7.Placethelancingdevicefirmlyagainstyourfinger
andpressthereleasebuttontoobtainablood
sample.Thelancetwillreturntoitsoriginalposition
afteruse.
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8.Afterfinishingyourbloodcheck,removetheend
cap,carefullyremovetheusedlancet,anddisposeof
thelancetsafelyinanappropriatecontainer.
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9.Foralternativesitetesting,pleaseseeChapter7.
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ControlSolution
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YourkitincludesacontrolsolutiontocheckyourIn
Touch™andteststripsareworkingproperly.The
controlsolutionisaliquidthatcontainsafixedamount
ofglucose.ItisusedtocalibrateyourInTouch™and
makessureyourreadingsareaccurate.
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Youcanalsousethissolutiontopracticetaking
readings,ortocheckthatyouarefollowingthecorrect
testingprocedurewithoutusingyourownblood.Ifthe
monitorreadingiswithinthecontrolsolution’s
acceptablerange,themeterisworkingcorrectly.
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Chapter4–GettingStarted
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TurningOnandSettingupyourInTouch™
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Youneedtodoverylittletosetupanduseyour
monitor.Itwillpartiallychargebutyourchecktomake
surethatthebatteryisatleast50%fullbeforeusingit
forthefirsttime.
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Tocheckthebatterystatuslookatthebatterygauge
iconinthetopleftofyourscreen,andthebarswithin
theicon.

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BylightlypressingthesideOn/Offbutton,theWake‐
Upscreenwillappear.Itwillbeepforafewsecondsas
itfindsthenetworkandautomaticallysetsthetime
anddayfollowedbytheHomescreen.
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Thetimeanddatearesetautomatically,nomatter
whereyouare,andareshownatthetopoftheHome
screen.Ifyouaretraveling,InTouch™willsetyour
monitor’stimetothetimezonethatyouareinsothat
yourmeasurementswillbesentwithrighttimestamp.
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Havingthecorrecttimeanddateofeachbloodtest
resultisimportantbecauseithelpsyouandyour
healthcareprofessionalunderstandyourbloodglucose