2ATGA01Remunity Pump for Remodulin

DocumentNumber DKPI-09153-001Rev.1.42020-06-0812:55:49PM ConfidentialityStatement DEKARESEARCH&DEVELOPMENTANDUNITEDTHERAPEUTICSCORP. PROPRIETARYRIGHTSAREINCLUDEDHEREIN.THISDOCUMENT CONTAINSDEKAANDUNITEDTHERAPEUTICSCORP.CONFIDENTIAL INFORMATIONANDMAYNOTBECOPIED,TRANSFERRED,OR DISCLOSEDEXCEPTASAUTHORIZEDBYDEKARESEARCH& DEVELOPMENTOR UNITEDTHERAPEUTICSCORP. Trademarks RemodulinisaregisteredtrademarkofUnitedTherapeuticsCorp. CONTENTS About7 ClinicalOverview9 EssentialPerformance10 IndicationsforUse11 Contraindications 11 Conventions11 Symbols13 Warnings21 ComponentWarnings 21 LocationofUseWarnings 23 CassetteChangeWarnings 25 MedicationDeliveryWarnings 26 Cautions26 Introduction29 SystemOverview30 StarterKit31 Disposables33 RemoteOverview34 PowerOFF 34 RemoteFront 35 FrontButtonScreenLabels 36 RemoteBack 37 HomeScreen38 PumpOverview39 PumpwithCassetteAttached40 RemovetheClearDustCover40 AttachtheClearDustCover41 HowtoWearYourPump41 BeltClip 42 InYourPocket 43 SetUp45 ChargethePumpBatteries46 ChargetheRemoteandOne PumpBattery48 DKPI-09153-001-Rev.1.41 PairRemoteandPumpforthe FirstTime52 EnterDeliveryRate57 CassetteChange59 CassetteChangewithRemote60 SuppliesNeededforCassette ChangewithRemote 61 StopDeliverywithRemote 63 DisconnectInfusionSite 65 DisconnectCassettefromPump andDispose 66 ReplacePumpBattery 68 PreparePrimingAid 70 ConnectandPrimeInfusionSet 73 StopPrimingandRemove PrimingAid 75 ConnectCassettetoPump 78 ConnecttoCatheter 80 StartDelivery 81 CassetteChangeWithoutRemote82 SuppliesNeededforCassette ChangewithoutRemote 83 StopDeliveryWithoutthe Remote 85 DisconnectCassettefromPump andDisposewithoutRemote 85 ReplacePumpBattery 87 PreparePrimingAid 89 ConnectandPrimeInfusionSet 92 StopPrimingandRemove PrimingAid 94 ConnectCassettetoPump withoutRemote 97 ConnecttoCatheter 99 StartDeliverywithoutRemote 99 MenuFunctions101 MainMenu102 ReturntoPreviousMenu 102 ChangeRate103 StopDelivery107 StartDelivery109 2DKPI-09153-001-Rev.1.4 HistoryMenu111 RemoteBattery 112 PumpCassetteInfo 113 Previous24Hours 114 EventViewer 115 Setup117 PairedPump 117 PairtoaSparePump 118 PairtoaSpareRemote 123 WalkawayAttentionAlarm 127 ScreenTimeout 129 RemoteAudio 130 ChangeRatePasscode 133 AirplaneMode 137 FactoryReset 140 RemoteFactoryReset 140 PumpFactoryReset 141 SystemInformation 144 Return 145 AlarmsandAttentionAlarms147 AboutAlarmsandAttention Alarms148 BatteryDepletedAlarm149 CassetteDepletedAlarm150 CassetteRemovedAlarm151 CassetteProblemAlarm153 OcclusionAlarm154 PumpErrorAlarm158 PumpFailureAlarm159 BasalNotStartedAttentionAlarm160 AdjustPumpAttentionAlarm160 DeliveryStoppedAttentionAlarm161 DepletesSoonAttentionAlarm162 ExcessiveNoiseAttentionAlarm162 MessageTimeoutAttentionAlarm163 NoCommunicationAttention Alarm164 PairingFailedAttentionAlarm166 PairingLostAttentionAlarm167 PumpIdleAttentionAlarm168 PumpBatteryLowAttention Alarm169 DKPI-09153-001-Rev.1.43 RemoteBatteryLowAttention Alarm170 RequestRefusedAttentionAlarm171 SoftwareVersionErrorAttention Alarm172 TechAttentionAlarm173 WalkawayAttentionAlarm174 MaintenanceandTroubleshooting175 PumpMaintenance176 RemoteMaintenance177 TroubleshootingBatteryCharger178 TroubleshootingRemote182 TroubleshootingPump189 PumpSounds197 FrequentlyAskedQuestions(FAQ)199 ServiceandSupport207 TechnicalSupport208 PartsandAccessories208 ApprovedInfusionSets 209 AppendixA211 TechnicalSpecifications212 EnvironmentalProtection Ratings 215 Start-upGraph 216 TrumpetCurve 217 RemunitySystemRadio Specifications 223 QualityofServiceProvisions 224 GuidanceandManufacturer’s Declaration-Electromagnetic Emissions 225 GuidanceandManufacturer’s Declaration-Electromagnetic Immunity 226 AppendixB237 Patient-FilledCassetteChange238 SuppliesNeededforCassette ChangewithRemote 239 StopDeliverywithRemote 241 DisconnectInfusionSite 243 DisconnectCassettefromPump andDispose 244 4DKPI-09153-001-Rev.1.4 ReplacePumpBattery 246 PrepareandFillCassette 248 ConnectandPrimeInfusionSet 253 StopPrimingandRemove PrimingAid 256 ConnectCassettetoPump 258 ConnecttoCatheter 261 StartDelivery 261 GLOSSARY263 INDEX267 EmergencyContactInformation275 DKPI-09153-001-Rev.1.45 Thispageintentionallyleftblank. 6DKPI-09153-001-Rev.1.4 About TheRemunity ™ PumpforRemodulin ® (treprostinil) Injectionisforsingle-patientuseonlyandthe Remunity ™ Cassetteisforsingleuseonly. TheRemunitysystem,whichconsistsofawearable infusionpump,refillcassettes,remoteinterface, andaccessories,continuallydeliversRemodulin ® subcutaneously(i.e.,undertheskin). IfyouhaveanyquestionsabouttheRemunity system,talktoyourhealthcareproviderorspecialty pharmacyrepresentative. ThisUserGuideprovidesimportantsafety informationabouttheRemunitysystem.Itis importanttoreadandunderstandallinstructions beforeusingtheRemunitysystem. KeepthisUserGuideinasafe,easilyaccessible placeforreference.Werecommendkeepingitina carryingcasealongwithyourothersystem accessories. Youmustbetrainedbyaqualifiedtrainerbefore youusetheRemunitysystem.Ifyouhavenot receivedtraining,pleasecontactyourspecialty pharmacy. ThepatientisidentifiedastheOperatorinthisUser Guide. Thefollowingitemsmustbeunderstoodpriortouse ofthe Remunitysystem: •TheOperatordemonstratestheyknowwhat needstobecarriedwiththemtofacilitatea cassetteand/orpumpbatterychange. •TheOperatorisabletoprogramthesystemwith anappropriatedeliveryrate. DKPI-09153-001-Rev.1.47 •TheOperatorisabletoadjustthedeliveryrate asinstructed. •TheOperatorunderstandsthatonlyRemodulin Remunitycassettesmaybeusedwiththe RemunitySystem. •TheOperatorunderstandstheyneedtoverify theproperRemodulinconcentrationpriorto usingacassette. •TheOperatorisabletoexecutetheproper procedureforchangingacassette. •TheOperatorisabletoexecutetheproper procedureforresolvinganalarm. •SuccessfulRemunityPumptherapyrequires sufficientphysical,cognitive,visualandhearing capabilitiestoallowrecognitionand manipulationoftheControllerandPump.Users musthaveaminimumof8yearsofeducationto correctlyinterpretthisUserGuide. TheOperatorshouldcontactlocalauthoritiesabout properdisposal…

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Introduction RemoteFront TheFrontButtonScreenLabelsdisplayedonthe screenareexecutedbypressingthecoinciding FrontButtonbelowthelabel. TounlocktheremotepresstheFrontButtonsin orderfromlefttoright. Onceunlocked,theremotescreenwillstay activefortheprogrammedScreenTimeout minutesbeforegoingintosleepmode.See "ScreenTimeout"onpage 129. DKPI-09153-001-Rev.1.435 FrontButtonScreenLabels RepeataFunction CancelorExitaFunction AccessHelpInformation SilenceAlarm EditaValue AcknowledgeorAccept ScrollUp/IncreaseaValue ScrollDown/DecreaseaValue NextScreen PreviousScreen PumpSettings UnlockScreen Introduction 36DKPI-09153-001-Rev.1.4 Introduction RemoteBack Theremoteincludesabayonthebacktostoreand chargeasparepumpbattery.Thisbatterydoesnot powertheremote. Contactyourlocalauthoritiestodeterminethe propermethodfordisposingofthedurable componentswhentheyarenolongerneeded. Thesecomponentshaveelectronicsthat containleadandLithiumPolymerbatteries. ThePumpBatteryStatusLightonthebottomofthe remoteindicatesthepumpbattery’scharging statuswheninthebay. ColorStatus GreenBatterychargingiscomplete AmberBatteryischarging BlinkingRedChargingFault DKPI-09153-001-Rev.1.437 HomeScreen TheHomeScreendisplaysdetailsaboutyour pump'smedicationdeliveryandanyconditionsyou needtoaddress,suchasAlarmsorAttention Alarms.See"AlarmsandAttentionAlarms"on page 147. ThecoloroftheStatusBarindicatestheremote’s connectiontothepumpandthecurrentdelivery: ConnectedandDelivering ConnectedandNOT Delivering NOTConnected Alarm AttentionAlarm Introduction 38DKPI-09153-001-Rev.1.4 Introduction PumpOverview ThePumpconnectstoaCassetteandpumps medicationunderyourskinatthedeliveryrateyou setusingtheremote.Thepumpwillcontinueto delivermedicationevenwhenitisnot communicatingwiththeremote. Thepump’sbluebuttoncanbepressedtostart medicationdelivery,exitairplanemode,andplace thepumpinpairingmode. Thepumpispoweredbyarechargeablepump batterythatisinsertedintothebatterybaylocated onthebottomofthepump.Everythreedaysyou mustreplacethepumpbatterywithafullycharged pumpbattery. Ifthepumphas beensubjected totheextremes ofspecified storage temperatures, beforeusingthe pumpallowitto cooloff/warmup foronehour. DKPI-09153-001-Rev.1.439 PumpwithCassette Attached RemovetheClearDust Cover ThepumpisshippedwithaClearDustCover attachedtoprotectthepump. 1.Removethecleardustcoverbyholdingthe dustcoverinonehandandrotatingthepump counterclockwisewiththeotherhand. 2.Separatethepumpfromthedustcover. Introduction 40DKPI-09153-001-Rev.1.4 Introduction AttachtheClearDustCover Wheneverthepumpisnotbeingused,storethe pumpwiththecleardustcoverinplace. 1.Alignthe pump-bump withtheunlock symbolonthe cleardust cover. 2.Holdingthe cleardust coverinone handandthe pumpinthe other,pushand rotatetothelocksymbolonthecleardust cover. HowtoWearYourPump YourPumpcanbeworn afewdifferentways: •Attachedtoabelt withtheincluded BeltClipaccessory •Placedinapocket Makesuretosecurethe infusionsettubingto preventitfromcatching onotherobjects. DKPI-09153-001-Rev.1.441 BeltClip 1.ThepumpslidesintotheBeltClipwiththeblue buttonfacinginward. 2.Slidethebeltclipontoyourbeltorother locationonyourbodythatwillfirmlysupport thepump. Introduction 42DKPI-09153-001-Rev.1.4 Introduction InYourPocket Insertthepumpintoyourpocketmakingsurethe infusionsettubingisnotpinched. DKPI-09153-001-Rev.1.443 Thispageintentionallyleftblank. Introduction 44DKPI-09153-001-Rev.1.4 Set Up SetUp Contactyourspecialtypharmacyforassistance withanyofthesetupinstructions. ChargethePumpBatteries46 ChargetheRemoteandOnePumpBattery48 PairRemoteandPumpfortheFirstTime52 EnterDeliveryRate57 DKPI-09153-001-Rev.1.445 ChargethePumpBatteries YoumustchargethePumpBatteriesbeforeyou canusethepump.Afullychargedpumpbattery canpowerthepumpfor3days(72hours). Eachtimeyoureplaceacassette,youshouldalso replacethepumpbatterywithafullycharged battery. Youcanchargeuptotwopumpbatteriesusingthe batterycharger,andonepumpbatteryusingthe remote.See"ChargetheRemoteandOnePump Battery"onpage 48. Thepumpbatterychargermaybeconnectedto anyUSBportforbatterycharging. ChargingthepumpbatteriesusingthedualUSB ACAdapterwilltakeabout6hours.Chargingthe pumpbatteriesusingonlytheUSBCable(e.g., throughapersonalcomputer)maytakemoretime. Ifthepumpbatterieshavebeensubjectedtothe extremesofthespecifiedstoragetemperatures, beforechargingorusingthebatteriesallowthemto cooloff/warmupfor20minutes. 1.PluginoneoftheUSBcablesintothebattery chargerandtheotherendoftheUSBcable intothedualUSBwalladapter. 2.ThenplugthedualUSBwalladapterintoan ACpoweroutlet. Set Up 46DKPI-09153-001-Rev.1.4 Set Up Avoidtouchingtheelectricalcontactson thebatterychargerwhenitisconnectedtoa powersource. 3.Inserttworechargeablebatteriesintothe batterychargerbyaligningthecontacts. 4.Amberbatterychargerstatuslight(s)indicate thebatteriesarecharging. ColorStatus GreenBatterychargingiscomplete AmberBatteryischarging BlinkingRedChargingFault DKPI-09153-001-Rev.1.447 5.Waituntilthepumpbatteriesarefullycharged beforeuse. Apumpbatteryisfullychargedwhenthe batterychargerstatuslight(s)aregreen. ChargetheRemoteandOne PumpBattery Youshouldchargetheremotebeforeuse.The remoteandpumpbatteryintheremotewilltypically fullychargein6hoursorlesswhenconnectedtothe supplieddualUSBACadapter. Thechargingtimefortheremotemaybelongerif connectedtopowersourcesotherthanthe supplieddualUSBwalladapter. Theremotewillworkforupto1day(24hours)ona fullcharge.Itisrecommendedtochargetheremote daily.Itisagoodhabittochargetheremoteevery evening. Theremoteischargedbyconnectingittothe supplieddualUSBACadapteroranyUSBport. Theremotecanalsobeusedtochargeapump batteryasyouarechargingtheremote. Youcanusetheremotewhileitischarging. Set Up 48DKPI-09153-001-Rev.1.4 Set Up Whenthesystemisusedinaloud environmenttheremoteshouldbekeptina pantorshirtpocketsothatthevibratory aspectofanalarmnotificationcanbefelt. Iftheremotehasbeensubjectedtotheextremesof thespecifiedstoragetemperatures,before chargingorusingtheremote,allowthedeviceto cooloff/warmupforonehour. 1.PlugthesecondUSBcableintotheb…

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Cassette Change 5.Presstosilencetheattentionalarm. 6.PresstoacknowledgethePumpdelivery hasstoppedAttentionAlarm. DisconnectInfusionSite 1.Disconnectthe infusionset tubingfromthe catheter. Refertothe instructions providedbyyour infusionset's manufacturerfor guidance. Youshouldconsultwithyourspecialtypharmacy abouthowoftentochangethecatheter. Donotremovethepumpfromtheused cassetteuntilafteryouhavedisconnectedthe infusionsettubingfromyourbody. Disconnectingthepumpbeforeyou disconnecttheinfusionsettubingfromyour bodycouldleadtounintendedmedication delivery. DKPI-09153-001-Rev.1.465 DisconnectCassettefrom PumpandDispose Toavoidunintendedmedicationdelivery, disconnectfromcatheterbeforedetachingthe cassettefromthepump. 1.Holdingthecassettestill,rotatethepump counterclockwiseuntilthepump-bumpis alignedwiththeUnlocksymbol. 2.Youshouldhearaonebeeptonecomingfrom thepump. Cassette Change 66DKPI-09153-001-Rev.1.4 Cassette Change 3.Separatethepumpfromthecassette. Avoidunnecessarycontactwithallpartson theinteriorofthepumpexposedduringthe cassettechangingprocess. Keepdirt,lubricantsandliquidsawayfromall partsontheinteriorofthepumpexposed duringthecassettechangingprocess. 4.Disposeofthe usedcassette andinfusionset tubingand catheter(if removed)inthe trash. Followyourinfusion set’sinstructions: •Ifyoualsoplanto changeyour catheterand/or infusionsite. •Forproperdisposalofinfusionsettubingand/or catheter. DKPI-09153-001-Rev.1.467 ReplacePumpBattery Avoidunnecessarycontactwithallpartsonthe interiorofthepumpexposedduringthebattery changingprocess. 1.Turnthepumpoverandusetheendofyour fingertoremovethebatteryfromthepump. 2.Beforeremovingtheremotefromthecharging outlet,checkthatthecharginglightonthe backoftheremoteisgreen.Thisindicatesthe batteryinthebayisfullycharged. Cassette Change 68DKPI-09153-001-Rev.1.4 Cassette Change 3.Opentheclearcoverandremovethefully chargedbatteryfromthebatterybay. Alternatively,youcanobtainafullycharged batteryfromthebatterycharger. 4.Insertthedepletedpumpbatteryintothe backoftheremote'sbatterybay. Attheendoftheday,remembertochargethe remotewiththeinsertedbattery. Alternatively,youcaninsertthedepleted pumpbatteryintothebatterychargertofully charge. DKPI-09153-001-Rev.1.469 5.Insertthebatteryintothepumpmakingsure thecontactsarealigned. 6.Thepumpwillsoundareadytone(onebeep). Keepdirt,lubricantsandliquidsawayfromallparts ontheinteriorofthepumpexposedduringthe batterychangingprocess. PreparePrimingAid Youcanuseeachpharmacy-filledcassetteforupto threedays.Replacethecassettewhenmedication runsoutorafterthreedays. Donotusepreviouslyopened,expiredor damageddisposablecomponents.Doingso mayleadtoinfection. Donotconnecttoinfusionsetcatheterinthe bodyuntilafteranewlypreparedcassetteis attachedtothepump.Connectingthe cassettetothebodybeforeattachingthe pumpmayleadtounintendeddelivery. Cassette Change 70DKPI-09153-001-Rev.1.4 Cassette Change 1.Youwillnotneedtofollowthestepstofillthe cassettewiththeamountdisplayedonthe RemoteforthePharmacy-Filledcassettes. 2.Openthepharmacy-filledcassettepackage andremovetheplasticclamshell. 3.Opentheplasticpackaging,,removethe primingaidwithpharmacy-filledcassette,and placetheblacksidedownonaflatsurface. Notetheimportantareasoftheprimingaid andpharmacy-filledcassetteassembly. DKPI-09153-001-Rev.1.471 4.Pressdownonthetopoftheprimingaiduntil youhearaclick. 5.RemovethecapfromtheLuerLock connector. Cassette Change 72DKPI-09153-001-Rev.1.4 Cassette Change ConnectandPrimeInfusionSet 1.Theinfusionsettubingshouldbechanged wheneveryouareperformingaCassette Change.Obtainanewinfusionsetpackage. 2.Opentheinfusionsetpackageandremovethe infusionsettubing. DKPI-09153-001-Rev.1.473 3.Connecttheinfusionsettothecassetteby twistingtheLuerLockconnectorstogether. Donotinsertthenewinfusionsetcatheterinto yourbodyuntilafteryouhavepreparedthe newcassetteandconnectedittothepump. Insertingtheinfusionsetcatheterbefore connectingthecassettetothepumpmaylead tounintendeddelivery. 4.Holdingthecassettestill,rotatethepriming aidclockwiseuntilyouhearaclickandthe arrowisalignedwiththedropsymbolonthe primingaidtab. Cassette Change 74DKPI-09153-001-Rev.1.4 Cassette Change 5.Watchformedicationdropstoappearatthe endoftheinfusionset. Seeingthemedicationdropsindicatesthe infusionsetandcassetteareprimed. StopPrimingandRemove PrimingAid 1.Assoonasyouseethefirstdropsfromthe infusionsettubing,rotatetheprimingaid counterclockwisetoendthepriming. DKPI-09153-001-Rev.1.475 2.Rotatecounterclockwiseuntilthetabonthe primingaidbecomesalignedwiththeUnlock symbolonthecassette. 3.Detachtheprimingaidfromthecassette. 4.Placethecassettedownonyourworkspace. 5.Wipeupmedicationresiduethatmayhave settledontopofthecassetteduringthefilling processwithanabsorbenttowelorcloth. Cassette Change 76DKPI-09153-001-Rev.1.4 Cassette Change 6.WipeupanyRemodulinmedicationresidue withanabsorbenttowelorclothandwashany areasthatcameincontactwithRemodulin withsoapandwater. 7.Disposeoftheprimingaidinthetrash. DO NOT disposeofthenewlyfilledcassette. DKPI-09153-001-Rev.1.477 ConnectCassettetoPump Donotconnecttheinfusionsettubingtoyour catheter. 1.Beforeconnectingthepumptothefilled cassette,inspectthecassetteandinfusionset tubingforleaks. Ifyouseeanyleaksreplacethecassetteand infusionsettubing. 2.Wipeupanymedicationresiduewithan absorbenttowelorclothandwashcontacted areaswithsoapandwater. 3.Alsochecktoensuretheinterfacesofthe pumpandcassettearefreeofdust,lintand debris. 4.Connectthefilledcassettetothepumpby aligningthepump-bumpwiththeUnlock symbolonthecassette. Cassette Change 78DKPI-09153-001-Rev.1.4 Cassette Change 5.Pushdownandrotatethepumpclockwiseto theLocksymbol. 6.Pump-bumpshouldalignwiththeinfusionset tubing. 7.Youshouldhearaseriesofbeepscomingfrom thepumpfollowedbyafinalconfirmation beep. DKPI-09153-001-Rev.1.479 OntheremoteaSelfTestdisplays. 8.AllowtheSelfTestontheremotetocomplete. Donotconnecttheinfusionsettubingtoan insertedcatheterbeforethepumpcompletes theselftests.Doingsomaycauseanover deliveryofmedicationresultinginharm. Connectt…

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Yourdeliveryrateandthehoursremainingonthe cassettedisplays. 2.Unlockthescreenbypressingeach frontbuttonfromlefttoright. TheMainMenudisplays. 3.UsethedownarrowtohighlightStop Delivery. AStopPumpDelivery?questiondisplays. 4.Presstostopmedicationdelivery. ASendingrequesttothepumpmessage displays. Menu Functions 108DKPI-09153-001-Rev.1.4 Menu Functions 5.Presstosilencetheattentionalarm. 6.PresstoacknowledgethePumpdelivery hasstoppedAttentionAlarm. StartDelivery Cellphones,Bluetoothdevices,RFIDreaders, andWi-Fiequipmentmayaffectthe communicationbetweenthePumpandRemote orinterruptoperationofthePump.Keepthe PumpandRemoteatleast0.8m[3ft]away fromtheseitems.SeeTable28onpage 223 andSeeTable30onpage 226formore information. DKPI-09153-001-Rev.1.4109 Whenthepumphasbeenstopped,thetopbanner changestoblue. 1.Pressany buttonto displaythe mainmenu. 2.UsethedownarrowtohighlightStart Delivery. AStartPumpDelivery?questiondisplayswith thelastrate. Menu Functions 110DKPI-09153-001-Rev.1.4 Menu Functions 3.Presstostartmedicationdelivery. ASendingrequesttothepumpmessage displays. HistoryMenu TheRemunity Systemstoresvariousinformation aboutrecentuseofthesystemandisviewable anytimewithintheHistoricalmenu. Thesystemcanstoreatleast1500entriesofthe followingevents: •CassetteVolume •DeliveryStart andStopped •DeliveryRate changes •Alarms •AttentionAlarms •Cassette changes •PumpBattery changes •RemotePoweredOnandOff •StartandFinishedSelfTest •ThePumpdeliveryvolumeoverthelast24hours DKPI-09153-001-Rev.1.4111 Whenthelogshavereachedthemaximum capacity,theoldestentrieswillbediscarded. Thelogsaremaintainedwhenthesystemis powereddownorlosespower. RemoteBattery TheRemoteBatteryhistoricalmenufeature displaystheremote'scurrentbatterychargelevel andchargingstate. 1.Presstheside buttontowake uptheremote. 2.Unlock thescreenby pressingeach frontbutton fromleftto right. 3.Usethedown arrowto scrolltoHistory. 4.Press. 5.TheRemoteBatteryoptionwillbehighlighted, press. Menu Functions 112DKPI-09153-001-Rev.1.4 Menu Functions 6.ReviewtheChargeandStateoftheremote batteryandpresswhenfinished. PumpCassetteInfo ThePumpCassetteInfodisplaysthepump's remainingvolumeandthetimeuntilthepumpis depleted. 1.Presstheside buttontowake uptheremote. 2.Unlock thescreenby pressingeach frontbutton fromleftto right. 3.Usethedown arrowto scrolltoHistory. 4.Press. 5.UsethedownarrowtoscrolltoPump CassetteInfo. DKPI-09153-001-Rev.1.4113 6.Press. ThePumpRemainingdatadisplays. 7.ReviewtheVolumeofmedicationleftinthe cassetteandtheTimeuntilthecassetteisfully depleted. 8.Presswhenfinished. Previous24Hours ThePrevious24Hoursdisplaysthevolumeof medicationdeliveredinthepast24hoursandthe amountoftimethepumpwasdeliveringinthelast 24hours. 1.Presstheside buttontowake uptheremote. 2.Unlockthe screenby pressingeach frontbuttonfrom lefttoright. 3.Usethedown arrowto scrolltoHistory. 4.Press. 5.UsethedownarrowtoscrolltoPrevious 24Hours. Menu Functions 114DKPI-09153-001-Rev.1.4 Menu Functions 6.Press. ThePumpLast24Hoursdatadisplays. 7.ReviewtheVolumeofmedicationdeliveredin thelast24hoursandtheamountofTimethe pumpwasdeliveringoverthelast24hours. 8.Presswhenfinished. EventViewer TheEventViewerdisplaysthefollowingtypesof historicaleventsalongwithhowlongagotheevent occurredandanyadditionalinformation: •DeliveryRatechanges •AlarmsandAlerts •Cassettechanges •Batterychanges •SelfTeststartandfinishevents •Deliverystartandstoppedevents 1.Pressthesidebuttontowakeuptheremote. 2.Unlockthescreenbypressingeach frontbuttonfromlefttoright. 3.UsethedownarrowtoscrolltoHistory. 4.Press. DKPI-09153-001-Rev.1.4115 5.UsethedownarrowtoscrolltoEvent Viewer. 6.Press. ThemostrecentEventHistorydatadisplays. 7.Usetheleftandrightarrowstoscroll throughthelistofevents. 8.PresstoreturntotheHistoricalMenu. Menu Functions 116DKPI-09153-001-Rev.1.4 Menu Functions Setup TheSetupmenuisusedtosetyourpersonal preferencesrelatedtotheremote’ssettingsand providesaccesstothefollowingfeatures: •PairedPump •Walkaway AttentionAlarm: ON/OFF •ScreenTimeout •RemoteAudio •Passcode: ON/OFF •AirplaneMode •FactoryReset •System Information PairedPump ThePairedPumpsettingdisplaysthepumpSerial Number. Toviewthecurrentlypairedpumpserialnumber: 1.Presstheside buttontowake uptheremote. 2.Unlock thescreenby pressingeach frontbutton fromleftto right. 3.Usethedown arrowto scrolltoSetup. 4.Press. 5.ThePairedPumpmenushouldbe highlighted,press. DKPI-09153-001-Rev.1.4117 Thecurrentlypairedpump'sserialnumber displays. 6.Presstoreturntothesetupmenu. PairtoaSparePump Cellphones,Bluetoothdevices,RFIDreaders, andWi-Fiequipmentmayaffectthe communicationbetweenthePumpandRemote orinterruptoperationofthePump.Keepthe PumpandRemoteatleast0.8m[3ft]away fromtheseitems.SeeTable28onpage 223 andSeeTable30onpage 226formore information. Ifthepumpyoucurrentlyusebecomeslostor damaged,youcanswitchtothesparepumpand pairyourremotetothesparepump. 1.Pressthesidebuttontowakeuptheremote. 2.Unlockthescreenbypressingeach frontbuttonfromlefttoright. 3.UsethedownarrowtoscrolltoSetup. 4.Press. ThePairedPumpmenushouldbe highlighted. Menu Functions 118DKPI-09153-001-Rev.1.4 Menu Functions 5.Press. Thecurrentlypairedpump'sserialnumber displays. 6.Presstopairtoadifferentpump. TheremotewilldisplaySearchingasitlocates thenewpump'sserialnumber. DKPI-09153-001-Rev.1.4119 7.Placethepumpandremotewithin2in(50 mm)ofeachotherduringthepairingprocess. 8.Ifyourpump'sserialnumberdoesnotshowup onscreenafteraminute,pressandholdthe pump’sbluebuttonfor10secondsto activatepairingmode.Then,checkthescreen againforyourpumpserialnumber. 9.Whenthenewpump'sserialnumberappears, usethetoscrolltothenewpump's serialnumberandpress. Menu Functions 120DKPI-09153-001-Rev.1.4 Menu Functions 10.Pressagaintoconfirmpair. APairingTo...messagedisplays. Ifpairingfails,see"PairingFailedAttention Alarm"onpage 166 DKPI-09153-001-Rev.1.4121 11.Uponsuccessfulpairing,presstoconfirm thePairedPump. a.Ifyouhavepreviouslyusedthepumporthe remote,yourcurrentdeliveryrateissaved andyoudonotneedtosetitagain.Skipto Step13. b.Ifthisisth…

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2.Unlockthescreenbypressingeachfront buttonfromlefttorighttounlocktheremote screen. Onceunlocked,screenwillstayactivefor2 minutesbeforegoingintosleepmode. 3.Placethepumpandremotewithin2in(50 mm)ofeachotherduringthepairingprocess. 4.Ifyourpump'sserialnumberdoesnotshowup onscreenafteraminute,pressandholdthe pump’sbluebuttonfor10secondsto activatepairingmode.Then,checkthescreen againforyourpumpserialnumber. Menu Functions 124DKPI-09153-001-Rev.1.4 Menu Functions 5.Ontheremote,usetohighlightthe pump'sserialnumberandpress. 6.Afterselectingyourpumpserialnumberyou willbepromptedtoconfirmtheselected pump.Presstoconfirm. DKPI-09153-001-Rev.1.4125 APairingTo...messagedisplays. Ifpairingfails,see"PairingFailedAttention Alarm"onpage 166 7.UponsuccessfulpairingthePairedPump messagedisplays.Press. Menu Functions 126DKPI-09153-001-Rev.1.4 Menu Functions WalkawayAttentionAlarm Tohelpyouavoidforgettingyourremote,settingthis featurewillletyouknowthatyoumayhaveleftyour remotebehind.TheWalkawayAttentionAlarm featurecanbesettogooffbetween1and120 minutes. TurnONWalkawayAttentionAlarm: 1.Pressthesidebuttontowakeuptheremote. 2.Unlockthescreenbypressingeach frontbuttonfromlefttoright. 3.UsethedownarrowtoscrolltoSetup. 4.Press. 5.PressthedownarrowtoWalkaway Alarm:OFF. 6.Press. 7.Ifneeded,pressthetoedittheWalkaway AttentionAlarmminutes. 8.Presstheupanddownarrowsto selectbetween1and120minutes. 9.Presstoacceptyourselection. DKPI-09153-001-Rev.1.4127 10.PressthefrontbuttonunderONtoturnONthe WalkawayAttentionAlarmfeature. 11.Presstoacceptyourselection. ASendingrequesttothepumpmessage displays. TurnOFFWalkawayAttentionAlarm: 1.Pressthesidebuttontowakeuptheremote. 2.Unlockthescreenbypressingeach frontbuttonfromlefttoright. 3.UsethedownarrowtoscrolltoSetup. 4.Press. 5.PressthedownarrowtoWalkaway Alarm:ON. 6.Press. Menu Functions 128DKPI-09153-001-Rev.1.4 Menu Functions 7.PressthefrontbuttonunderOFFtoturnOFF theWalkawayAttentionAlarmfeature. 8.Presstoacceptyourselection. ASendingrequesttothepumpmessage displays. ScreenTimeout TheScreenTimeoutfeatureallowsyoutosetthe timebeforetheremote'sscreenwillsleep. 1.Pressthesidebuttontowakeuptheremote. 2.Unlockthescreenbypressingeach frontbuttonfromlefttoright. 3.UsethedownarrowtoscrolltoSetup. 4.Press. 5.PressthedownarrowtoScreenTimeout. 6.Press. DKPI-09153-001-Rev.1.4129 7.Presstheupanddownarrowsto selectoneoffourtimes: •One minute •Two minutes •Five minutes •Ten minutes 8.Pressto acceptyour selection. Anytimetheremotehasnotbeenusedand theprogrammedscreentimeoutminuteshave passed,youwillneedtopressthesidebutton towakeuptheremote. RemoteAudio TheRemoteAudiofeaturecontrolsthefeedback andvolumeoptionsfortheremote. FeedbackOptions 1.Pressthesidebuttontowakeuptheremote. 2.Unlockthescreenbypressingeach frontbuttonfromlefttoright. 3.Usethedown arrowto scrolltoSetup. 4.Press. 5.Pressthedown arrowto RemoteAudio. 6.Press. Menu Functions 130DKPI-09153-001-Rev.1.4 Menu Functions 7.TheFeedbackoptionisalreadyhighlighted. 8.Press. 9.Presstheupanddownarrowsto selectoneofthreefeedbackoptions: •AudioandVibration •AudioOnly •VibrationOnly 10.Presstoacceptyourselection. VolumeOptions 1.Pressthesidebuttontowakeuptheremote. 2.Unlockthescreenbypressingeach frontbuttonfromlefttoright. 3.UsethedownarrowtoscrolltoSetup. 4.Press. 5.Pressthedown arrowto RemoteAudio. 6.Press. DKPI-09153-001-Rev.1.4131 7.PressthedownarrowtotheVolume option. 8.Press. 9.Presstheupanddownarrowsto selectoneoffivevolumelevels. 10.Presstoacceptyourselection. Menu Functions 132DKPI-09153-001-Rev.1.4 Menu Functions ChangeRatePasscode TheChangeRatePasscodeisOffbydefault.When turnedOnapasscodewillberequiredtochange therate. TurnONChangeRatePasscode 1.Pressthesidebuttontowakeuptheremote. 2.Unlockthescreenbypressingeach frontbuttonfromlefttoright. 3.UsethedownarrowtoscrolltoSetup. 4.Press. 5.PressthedownarrowtoPasscode:OFF. 6.Press. DKPI-09153-001-Rev.1.4133 7.PressthefrontbuttonunderON. 8.Usetheupanddownarrowstoscroll throughthefirstdigitselection. Menu Functions 134DKPI-09153-001-Rev.1.4 Menu Functions 9.Whenyouhavethedesirednumberpressthe rightarrow. 10.RepeatStep8andStep9fortheremaining threedigits. 11.ConfirmthepasscodebyrepeatingStep8and Step9toenteryournewfourdigitpasscode. AmessagedisplaysthatthePasscodeis Enabled. 12.PresstoreturntotheSetupMenu. DKPI-09153-001-Rev.1.4135 TurnOFFChangeRatePasscode 1.Pressthesidebuttontowakeuptheremote. 2.Unlockthescreenbypressingeach frontbuttonfromlefttoright. 3.UsethedownarrowtoscrolltoSetup. 4.Press. 5.Pressthedown arrowto Passcode:ON. 6.Press. 7.Pressthefront buttonunder OFF. 8.Usetheupanddownarrowstoenterthe firstdigitofyourcurrentpasscode. 9.Whenfinishedenteringthenumberpressthe rightarrow. 10.RepeatStep8andStep9fortheremaining threedigits. Menu Functions 136DKPI-09153-001-Rev.1.4 Menu Functions AmessagedisplaysthatthePasscodeis Disabled. 11.PresstoreturntotheSetupMenu. ForgotMyChangeRatePasscode Ifyouhaveforgottenyourchangeratepasscode, youwillneedtofollowthestepstofactoryresetyour remoteandpairtospareremote.See"Factory Reset"onpage 140. AirplaneMode Ifyouareaskedtoturnoffallelectronicdevices duringacommercialflight,followthestepstoput thedeviceintoairplanemode. 1.Pressthesidebuttontowakeuptheremote. 2.Unlockthescreenbypressingeach frontbuttonfromlefttoright. 3.UsethedownarrowtoscrolltoSetup. 4.Press. 5.Pressthedown arrowto Airplane Mode. 6.Press. DKPI-09153-001-Rev.1.4137 7.Presstoenableairplanemode. ASendingrequesttothepumpmessage displays. APressandholdpumpbuttontoexitmessage displays. Thepumpwillcontinuetodeliver medicationevenwhentheremoteisin airplanemode. Menu Functions 138DKPI-09153-001-Rev.1.4 Menu Functions Whentheuseofelectronicsisclearedduringa commercialflightyoucanexitairplanemode. 8.Youwillneedtopressandholdtheblue pumpbuttonuntilafteryouhearthefour-tone deliveringsoundtoexitairplanemode. 9.VerifytheremotedisplaysDeliveringonthe Homescreen. DKPI-09153-001-Rev.1.4139 FactoryReset AFactoryResetshouldnotbeperformedunless directedbyyourspecialtypharmacist. 1.Pressthesidebuttontow…

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