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Appendix

Governing Law and Jurisdiction
This Warranty (and any non-contractual obligations arising out of or in connection with it) is

governed by the laws of your country of residence. Any court of competent jurisdiction in your

country of residence will have exclusive jurisdiction and venue for any dispute arising out of or

in connection with this Warranty.

Effective Date: 27SEP2019, ECO-000240

Содержание INT2-D001-MM-OUS2

Страница 1: ...ade marks or registered trademarks of Insulet Corporation in the United States of America and in various others jurisdictions All rights reserved Reference number PDM INT2 D001 MM PT 000002 GBR ENG MM...

Страница 2: ...2942 358985653300 France omnipod FR insulet com 0800918442 33185653747 Germany omnipod DE insulet com 08001821629 496915408728 Israel 036900300 6364 97236900300 Italy omnipod IT insulet com 800587270...

Страница 3: ...epropertyoftheirrespectiveowners Theuseofthird partytrademarksdoesnotconstituteanendorsementorimplya relationshiporotheraffiliation Patentinformationatwww insulet com patents PT 000002 GBR ENG MM AWRe...

Страница 4: ...M 2 Navigating Screensand Entering Information 4 Touchscreen Basics 4 Entering NumbersandText 5 Navigation Iconsand Navigation Shorthand 7 The Status Bar 9 The PDM s Lockand PIN Screens 10 The PDM s H...

Страница 5: ...Abovevalues 31 MinimumBGforCalcs 32 InsulintoCarbRatio 33 CorrectionFactor 33 ReverseCorrection 34 DurationofInsulinAction 34 Other Bolus Settings 35 MaximumBolus 35 Extendedbolussetting 35 PDM Setup...

Страница 6: ...us 63 Trackingthe Progressofa Bolus 65 Alteringa Bolusin Progress 66 6 ModifyingBasalInsulinDelivery 69 UsingTemporary Basal Rates 69 Activateatempbasal 69 Activateatempbasalpreset 71 Cancelatempbasal...

Страница 7: ...PDM Device Settings 93 Networkconnectivity 93 Screendisplay 94 Lockscreen 94 Dateandtimeandlanguage 95 Diagnostics 97 Pod Sites Setting 98 Reminder Settings 98 Podexpiry 99 Lowreservoirlevel 99 PodAu...

Страница 8: ...Silencingan Alarm 123 Podalarm 123 PDMalarm 123 11 TakingCareofYourPDMandPod 125 Podand Insulin Care 125 Podandinsulinstorage 125 Podsandtheenvironment 125 CleaningyourPod 126 PDM Care 126 PDMstorage...

Страница 9: ...Bloodglucosesummaries 158 Insulindeliverysummaries 159 13 LivingwithDiabetes 161 Daily Activities 161 Infusionsitechecks 161 Checkyourbloodglucosefrequently 162 Preparefor Emergencies 163 Travellingan...

Страница 10: ...m Over infusionor Under infusion 180 OmnipodDASH System Label Symbols 180 Medical Device Directive 182 EU General Data Protection Regulation GDPR 182 EU Authorised Representative Details 182 Omnipod D...

Страница 11: ...x Thispageintentionallyleftblank Effective Date 27SEP2019 ECO 000240...

Страница 12: ...tute formedicalorhealthcareadvice recommendationsand orservicesfroma qualifiedhealthcareprovider ThisUserGuidemaynotberelieduponinanyway inconnectionwithyourpersonalhealthcare relateddecisionsandtreat...

Страница 13: ...n lispro Admelog insulinlispro andApidra insulinglulisine NovoRapid Fiasp HumalogandAdmelogarecompatiblewiththeOmnipodDASH Systemforuseupto72hours 3days Apidraiscompatiblewiththe OmnipodDASH Systemfor...

Страница 14: ...ibedinthisUser Guide contactyourhealthcareprovider TheOmnipodDASH SystemshouldNOTbeusedatlowatmospheric pressure below700hPA Youcouldencountersuchlowatmospheric pressuresathighelevations suchaswhenmou...

Страница 15: ...ulinremainsactiveand availableinyourbodyafteracorrectionormealbolus Yourhealthcareproviderisavaluableresource Youwillrelyonhimorherfor criticalinformationaboutyourOmnipodDASH System especiallyduring t...

Страница 16: ...andon screenmessages Alarmsandnotifications Foryoursafety theOmnipodDASH Systemprovidesarangeofalarmsand notificationstotellyouthatyourattentionisneededortowarnyouofhazardous situations Foradescriptio...

Страница 17: ...xvi Thispageintentionallyleftblank Effective Date 27SEP2019 ECO 000240...

Страница 18: ...loodglucosereadingsfromanyBG meterintothePDM Alternatively youcanenterglucosereadingsfromaCGM indicatedfordosinginsulin Recordkeeping ThePDMdisplaysupto90daysofinformation includingbasal rates bolusdo...

Страница 19: ...atyoufillwithinsulinandweardirectlyonyour body ThePodreceivesinsulindeliveryinstructionsfromthePDM ThePodthen deliversinsulinintoyourbodythroughasmall flexibletubecalledacannula ThePodisappliedtoyours...

Страница 20: ...DMisahandhelddevicethatcontrolsandmonitorsthePod soperations usingwirelesstechnology Notused Notused Backbutton Touchscreen Powerbutton Usedfor wake sleep andon off Sound vibrate button Micro BUSBport...

Страница 21: ...chscreenareexplainedhere Tap Touchthescreen thenliftyourfingerup Swipe Touchastartingpointandmoveyourfingerup down leftorright Note Scrollingandswipingarerelatedactions Whenyouswipeup thescreendisplay...

Страница 22: ...addittothetextfield Touchaletterinthetoprowforasecondto displayotheroptionssuchasanumberoran accentedlettersuchas Taptheuparrow totogglebetween uppercaseandlowercaseletters Taptheup arrowtwiceinrapids...

Страница 23: ...ntoselectalargernumber Thefaster youmoveyourfinger thefasterthewheelwillscroll Whenyourdesiredselectionisshowninthecentreofthewheel selectthevaluebytappingitorbytappingoutsidethescrollwheel Usingaslid...

Страница 24: ...rrow nexttoanitem Thecurrentlyselectedsettingappears totheleftofthedrop downarrow Toselectadifferent option tapthedownarrowtoshowthedrop down listofoptions Toreplacethecurrentlyselectedoption atthetop...

Страница 25: ...Pod CHANGEPOD tellsyouto 1 TaptheMenuicon intheupperleftoftheHomescreen 2 TapPodtoopenthePodscreen 3 TapCHANGEPOD Menuicon History Insulin BGHistory tellsyouto 1 TaptheMenuicon intheupperleftoftheHome...

Страница 26: ...nttime Statusbaricondefinitions Morethan50unitsinthePod Flightmodeon Between50and26unitsinthePod Vibrationmodeon Between25and5unitsinthePod Bluetooth settingon Lessthan5unitsinthePod Tempbasalrateacti...

Страница 27: ...isUserGuide instructionsto wakeup or unlock the PDMmeantodothefollowing 1 PressthePowerbuttonbriefly SeethePDMimageonpage3forthelocation ofthePowerbutton 2 UnlocktheLockscreenbyeitherswipinglefttorigh...

Страница 28: ...N callCustomerCare The PDM s Home Screen TheHomescreenprovidesinformationaboutrecentboluses bloodglucose values theactivebasalrateandtheactivePod ItalsoprovidesaccesstothePDM functions alarminformatio...

Страница 29: ...hboard tab TheDashboardtabisavailableifthe BolusCalculatorisonandisusuallynot availableiftheBolusCalculatorisoff WhentheBolusCalculatorison WhentheBolusCalculatorison the Dashboardtabdisplays IOB insu...

Страница 30: ...ereisanactiveBasal Program agreenlinemarksthe currenttime Thenumbersabovethe graphindicatethebasalrateforeach timesegment Thetotaldailyamountofbasal insulinisshownbeneaththegraph Thistotalistheamounto...

Страница 31: ...n See Whatthe PodcandobetweenPDMinstructions onpage135fordetails Tip BringingthePDMandtheactive Podwithin1 4metres 5feetofone anothermayquicklyrestoretheir communication IfthereisnoactivePod thePodInf...

Страница 32: ...sonthePod Infotab Whenlessthanfiveunitsofinsulin remaininthePod aredLowReservoir bannerappearsonthePodInfotab If the Podisgoingtoexpiresoonand therearelessthanfiveunitsofinsulinin thePod theredLowRese...

Страница 33: ...ringaboluswhentheBolusCalculatorisoff WhenabolusisbeingdeliveredandtheBolusCalculatorisoff thelowerleftof thescreenshowstheamountoftheprecedingbolus nottheongoingbolus BolusinformationifthePDMcannotco...

Страница 34: ...pbasal changing yourPod enteringabloodglucosereadingand suspendingorresuminginsulin Specialsituations SetTempBasalisgreyed outifthereisno activePod insulinissuspendedoratemp basalisalreadyrunning SetT...

Страница 35: ...TempBasal Bolus Tip TaptheSettingsicon atthetopoftheHomescreentoopentheSettings portionoftheMenu Thesesettingsallowyoutochangethetimeanddate createorremovereminders turntheBolusCalculatoronoroff andm...

Страница 36: ...lertyoutosomeaspectofthePDMorPodthatneeds yourattentioninthenearfuture Forexample ifthelevelofinsulininyourPod is gettinglow thePDMissuesanadvisoryalarm Notifications Notifications remindyouaboutactio...

Страница 37: ...20 Thispageintentionallyleftblank Effective Date 27SEP2019 ECO 000240...

Страница 38: ...Introduction onpage xi YourOmnipodDASH InsulinManagementSystem onpage 1and TakingCareofYourPDMandPod onpage 125 Warnings DoNOTusetheOmnipodDASH Systembeforeyouhavebeentrained Inadequatetrainingcouldp...

Страница 39: ...ies Vialofrapid actingU 100insulin Alcoholprepswabs InstructionsfromyourhealthcareproviderwithPDMsettingstailoredto yourneeds ThesesettingsincludeBasalProgram ICRatio Correction Factor TargetBGvaluesa...

Страница 40: ...to swipefromlefttorightacrossthescreen Note IfyouseeanunexpectedscreeninsteadoftheOmnipodDASH logo screen see TroubleshootingPDMStart up onpage175 3 TapalanguagetoselectyourpreferredlanguageforthePDMs...

Страница 41: ...rsbeforeusingit Enter a PIN Toprotectagainstunintentionalscreen touches youmustcreatea4 digitpersonal identificationnumberorPIN 1 ChoosefournumberstobeyourPIN YouwillusethisPINnumberevery timeyouwakeu...

Страница 42: ...lay 5 PlaceyourfingerontheHourscroll wheel Slideyourfingerupordown toscrollthewheelupordown Stop scrollingwhenthecorrecthour appearsinthecentreofthewheel 6 ScrolltheMinutescrollwheelupor downuntilthec...

Страница 43: ...timeanddate If correct tapCONTINUE Basal Insulin Settings Maximum Basal Rate TheMaximumBasalRatesetstheupper limitofanybasalinsulinratethatyoucan use 1 TapSETUPPROFILE 2 Reviewthedescriptionofbasal in...

Страница 44: ...tap theProgramNamefieldandenterthenewname see Selecting Adding and DeletingItems onpage 7 andthentaptheticksymbol 3 Optional ToaddavisualicontoyourBasalProgram taponeofthetags Tap thetagasecondtimeto...

Страница 45: ...edingstepsasneededuntilyourfinalsegmentendsat midnight Afterspecifyingabasalrateforthefinalsegment yourBasalProgramiscomplete ReviewtheBasalProgram Thenextscreensummarisesthestartandendtimes durationa...

Страница 46: ...efinetheendtimeandbasalrateforanyfollowingsegments as needed 6 WhentheBasalProgramiscorrect tapSAVE Note Ifthebasalrateforasegmentis0U hr thePDMdisplaysamessagecalling thistoyourattention TapOKifthe0U...

Страница 47: ...thearrow 2 Todefinethelowerlimit tapthe LowerLimitfieldandtypethenumber usingthenumberpad Tip Alternatively youcantouchthe lower red circlewithyourfingerand slideitupordown 3 Todefinetheupperlimit tap...

Страница 48: ...culatoraimstobringyour bloodglucosetotheTargetBGvalueif yourcurrentbloodglucoselevelisabove theCorrectAbovevalue Youcanestablish uptoeightdifferentbloodglucosetargets fordifferenttimesofday Definethes...

Страница 49: ...eededany remainingsegments 3 Whenthesegmentsandvaluesare correct tapSAVE Minimum BG for Calcs Ifyourbloodglucoselevelisbelowthe MinimumBGforCalcsthatyouspecify theBolusCalculatorisdisabled see The Bol...

Страница 50: ...untilthefinalendtimeismidnight 6 Reviewyour24 hourICRatio segments Tapanyentrytocorrectit 7 Whenthesegmentsandvaluesare correct tapSAVE Correction Factor YourCorrectionFactordefineshowmuch oneunitofin...

Страница 51: ...positionifyouwanttheBolusCalculatortoreducethe suggestedmealboluswhenyourbloodglucoseisbelowyourTargetBG SelecttheOffpositionifyoudonotwanttheBolusCalculatortoadjust thesuggestedmealbolusbasedonalowbl...

Страница 52: ...oradescriptionoftheextendedbolusfeature seepage142 1 ToggletheExtendedBolusbuttontoturntheextendedbolusfeatureonor off 2 TapCOMPLETE ThePDMrestarts PDM Setup Complete Congratulations YourPDMisnowready...

Страница 53: ...36 Thispageintentionallyleftblank Effective Date 27SEP2019 ECO 000240...

Страница 54: ...ticketoacidosis DKA DKA cancausesymptomssuchasabdominalpain nausea vomiting breathing difficulties shock comaordeath Ifinsulindeliveryisinterruptedforany reason youmayneedtoreplacethemissinginsulin As...

Страница 55: ...tetothePodchangescreen Home PodInfotab VIEWPOD DETAILS or Menuicon Pod 2 TapCHANGEPOD thentap DEACTIVATEPOD Ifatempbasalorextendedboluswas running itwillbecancellednow Ifyouseeacommunicationerror mess...

Страница 56: ...rifnecessary useanadhesiveremover c Checktheinfusionsiteforsignsofinfection see AvoidInfusionSite Infections onpage49 d DisposeoftheusedPodaccordingtolocalwastedisposalregulations 4 ToactivateanewPod...

Страница 57: ...ilityofsiteinfection doNOTapplyaPodwithoutfirst usingtheaseptictechnique Thismeansto Washyourhands Cleantheinsulinvialwithanalcoholprepswab Cleantheinfusionsitewithsoapandwateroranalcoholprepswab Keep...

Страница 58: ...insulinvialandinjecttheair Injectingairmakesit easiertowithdrawinsulinfromthevial 7 Turnthevialofrapid actingU 100insulinand thefillsyringeupsidedown Pulldownonthe plungertowithdrawthedesiredamountof...

Страница 59: ...ofthePod Thearrowpointstotheinsulin fillport Tip YoucanleavethePodinitstray duringfillingandpairing 2 Insertthefillsyringestraightdown notatanangle intothefillport 3 Depressthefillsyringeplungerto tra...

Страница 60: ...cess 2 TapNEXT IfmorethanonefilledDASHPodis inrange thePDMinformsyouofthis Moveatleast1 5m 5ft awayfromany otherDASHPodandtapTRYAGAIN IfonlyonePodisinrange theOmnipod DASH Systemperformsaseriesofsafet...

Страница 61: ...Thesiteshouldbeatleast5cm 2inches awayfromyournavel Avoidsiteswherebelts waistbands ortightclothingmayrubagainstor dislodgethePod AvoidsiteswherethePodwillbe affectedbyfoldsofskin AvoidplacingthePodov...

Страница 62: ...youcouldaddadetailthatsays Facingup or Facingdown to describethePod sorientation a Toaddanewdetail tapADDNEWandtypeinthenewdetail TapADD whenfinished Thenewdetailisaddedtothelist Note ThePDMconsidersu...

Страница 63: ...hePodsotheblueneedlecapis upandfacingyou 2 Placeyourthumbonthebottom flat edge ofthebluecapandpullthecap upwards Thecapsnapsoff Throwthe capaway Whenyouremovethebluecap adrop ofinsulinmaybevisibleatth...

Страница 64: ...nfusionsite Note ThePod sadhesivekeepsitsecurelyinplaceforuptothreedays However ifnecessary severalproductsareavailabletoenhanceadhesion Askyourhealthcareproviderabouttheseproducts Avoidgettinganyloti...

Страница 65: ...apinkcolourinthearea indicatedinthefigure Thisisanadditionalcheck thatthecannulawasinserted 3 Verifythatthereisnowetnessorscentofinsulin attheinfusionsite Thepresenceofeithermay indicatethatthecannula...

Страница 66: ...serveanyproblemswiththePod replaceitwithanewPod Warnings CheckoftentomakesurethatthePodandsoftcannulaaresecurelyattached andinplace Alooseordislodgedcannulamayinterruptinsulindelivery Verifythattherei...

Страница 67: ...M Ifthat isnotsuccessful youcanmanuallyturnoffthePodalarm see Silencingan Alarm onpage 123 TounderstandthePod sinformationalandnotificationbeeps includingwhich beepsareoptional see NotificationsList o...

Страница 68: ...sesyoutodoso Entering Your Blood Glucose Reading Note Onlyenterbloodglucosereadings donotentercontrolsolutionreadings Anyreadingsyouenterareaveragedinto yourbloodglucosehistoryrecords Toenteryourblood...

Страница 69: ...ormationaltagstothebloodglucose readingshowninthecircle see TaggingYourBloodGlucoseReading on page 53 5 Afterthebloodglucosereadingandanytagsareentered dooneofthe following TapADDTOCALCULATORtosaveany...

Страница 70: ...eference Forexample youmaytagtheblood glucosereadingaspre meal Toaddatagtothecurrentbloodglucose reading 1 TapADDTAGS 2 Tapatagtoselectit Youcanaddupto fourtags 3 Toremoveatag tapthetagagainto deselec...

Страница 71: ...display Screenwarningmessage Above33 3mmol LorHI HI TreatyourhighBG Ifitremains high seekmedicaladvice 14 0 33 3mmol L BGreading TreatyourhighBG Ifitremains high seekmedicaladvice 3 9 13 9mmol L BGrea...

Страница 72: ...ss headacheorconfusion followyourhealthcare provider srecommendationtotreathypoglycaemia Ifyougeta TreatyourhighBG Ifitremainshigh seekmedicaladvice readingmessageandfeelsymptomssuchasfatigue thirst e...

Страница 73: ...56 Thispageintentionallyleftblank Effective Date 27SEP2019 ECO 000240...

Страница 74: ...dBolus onpage 63 Bolusing with the Bolus Calculator TheBolusCalculatorcalculatesasuggestedbolusamountofinsulintocorrectan elevatedbloodglucoselevel acorrectionbolus and ortocovercarbohydratesin ameal...

Страница 75: ...dtap theticksymbol Note Consultyourhealthcare providerabouthowtocalculatethe gramsofcarbs 3 Reviewthesuggestedmealbolus whichisshownnexttothegramsof carbs 4 Optionally tapCALCULATIONSto seethedetailso...

Страница 76: ...nthecircleandenterthebloodglucosereading Alternatively slidetheindicatoralongthecircletoenterthebloodglucosereading WhiletheBolusCalculatorwilluseanybloodglucosevalueyouenter manually youshouldonlyent...

Страница 77: ...belowtheTotalBolusfield Toreviewanddeliverthebolus 1 Reviewthesuggestedbolus Toadjust it taptheTotalBolusfieldandentera revisedbolus 2 ToreviewtheBolusCalculator s calculations tapCALCULATIONS Youmayn...

Страница 78: ...wfieldandtypeinthe percentageofthebolustobe deliveredimmediately Alternatively taptheExtended fieldandenterthepercentagetobe extended Thenumberofunitstobe deliverednowandoverthe extendedperiodappearbe...

Страница 79: ...lusscreenalsoshowshowmuchoftheboluswillbe deliveredimmediatelyandhowmuchwillbeextended AdjustedforIOBofxU meansthattheBolus CalculatortookIOB intoaccount see page133 page157 Thetotalbolus includesanyI...

Страница 80: ...bolusisabolus thatyoucalculateyourself IftheBolus Calculatorissetto off oristemporarily disabled youmustenteramanually calculatedbolus Aboluscannotbegreaterthanyour MaximumBolussetting see Maximum Bol...

Страница 81: ...denter thedurationfortheextended portionofthebolus d TapCONFIRM 5 ReviewthebolusdetailsontheConfirmBolusscreen 6 Optional Setuparemindertocheckyourbloodglucoseasfollows a TapCREATEBGREMINDER b TaptheC...

Страница 82: ...usinProgress onpage 66 Extendedbolusprogress Duringanextendedbolus theHome screen sDashboardtabdisplaysa DeliveringExtendedBolusmessagealong withaprogressbarandotherdetails Note IftheBolusCalculatoris...

Страница 83: ...s tapCANCEL 2 TapYEStoconfirmcancellingthebolus ThePodbeepstoconfirmthatthe bolusiscancelled Deliveranewbolusduringanextendedbolus Todeliveranimmediateboluswhileanextendedbolusisinprogress 1 OntheHome...

Страница 84: ...LBOLUS Verifythatthenewtotalbolusis correct ThentapEXTENDBOLUS Note TheBolusCalculatorconsidersthisaddedamounttobeauser adjustmenttothenewbolus Thisaddedamountwillbedeliveredover thesamedurationasthen...

Страница 85: ...68 Thispageintentionallyleftblank Effective Date 27SEP2019 ECO 000240...

Страница 86: ...tebolus but you canactivateorcancelatempbasalwhileanextendedbolusisrunning Tocreateatempbasalpresetforafrequentlyusedtempbasal see Createanew tempbasalpreset onpage 79 Toactivateatempbasalpreset see A...

Страница 87: ...deliveryforthedurationofthetempbasal bysettingadecreaseof100 orsettingthetempbasalto0U hr Formore information see Tempbasallimitations onpage 140and Methodsto temporarilystopinsulindelivery onpage 141...

Страница 88: ...npage 79 Toactivateatempbasalpreset 1 Navigateto Menuicon TempBasalPresets 2 Swipetoscrollupordown andtapthetempbasalpresetthatyouwantto activate 3 Tochangethedurationofthetempbasal tapEDIT 4 Toactiva...

Страница 89: ...ollowingways ToseeagraphofaninactiveBasalProgrampriortoactivatingit tapon thenameofthatBasalProgram ThentapACTIVATE Tip Double tapthegraphtoseeanexpandedviewoftheBasalProgram Swipehorizontallytoviewba...

Страница 90: ...ndInsulin 2 TaptheSuspendInsulinforfield Scrollthescrollwheeltospecifythe durationofinsulinsuspension The suspensioncanlast30minutes 1 hour 1 5hoursor2hours 3 TapSUSPENDINSULIN 4 TapYEStoconfirmthatyo...

Страница 91: ...terthe suspensionperiodends 1 WakeupyourPDM ifnecessary 2 TapRESUMEINSULINtoresume insulindelivery ThePDMactivatestheBasalProgram thatisscheduledforthecurrenttimeand beepstoalertyouthatinsulindelivery...

Страница 92: ...Program TocreateanewBasalProgram 1 NavigatetotheCreateBasalProgramscreen Menuicon BasalPrograms 2 TapCREATENEW Note Ifyoualreadyhave12BasalPrograms CREATENEWdoesnotappear Ifnecessary youcandeleteanex...

Страница 93: ...viewbasalratesforlaterorearliertimes ToeditanyofthesegmentsintheBasalProgram seesteps7 9under Editor renameaBasalProgram onpage 77 9 TapSAVEtostorethenewBasalProgram 10 IfyouhaveanactivePodandyouwantt...

Страница 94: ...ththegraphof theactiveprogram Thentap SUSPENDINSULIN ToeditaninactiveBasalProgram taptheOptionsicon nextto theBasalProgramyouwouldlike toedit ThentapEdit 4 TorenametheBasalProgram taptheProgramNamefie...

Страница 95: ...gmentyouwanttodelete d TapNEXT e Thendefinetheendtimeandbasalrateforanyfollowingsegments as needed 10 WhentheBasalProgramiscorrect tapSAVE 11 ToactivatethenewlyeditedBasalProgram Ifyoueditedthecurrent...

Страница 96: ...ary youcandeleteanexistingpreset 3 Optional TapthePresetNamefieldandenteradescriptivenameforyour preset Thedefaultnameforthepresetis TempBasalPresets followedbya number 4 Optional Tapatagtoappearnextt...

Страница 97: ...padifferenttag Tapagaintodeselectatag 5 TapNEXT 6 Changethebasalrateanddurationasdesired 7 TapCONFIRM 8 TapSAVEtosaveyourchanges 9 Ifyouwouldliketostartthistempbasalnow tapACTIVATE Otherwise tap NOTNO...

Страница 98: ...eBolusPresetsscreen OntheHomescreen taptheBolus button or Menuicon BolusPresets 2 TapSELECTFROMPRESET 3 TapCREATENEW Note Ifyoualreadyhavesevenbolus presets CREATENEWdoesnotappear Ifnecessary youcande...

Страница 99: ...setNamefieldandenterthenewname 5 Tochangethetag tapadifferenttag Tapagaintodeselectatag 6 TapNEXT 7 Tochangethebolusamount taptheTotalBolusfieldandentertheunitsof insulin 8 TapSAVEtosaveyourchanges De...

Страница 100: ...thedateandtime butPDMrecordsareunaffected Notifications Alarms Screens Toreviewpastalarmsandnotifications 1 Tapthebellicon foundinthe upperrightofmanyscreens Ifyouhavenewnotifications the numberofnewn...

Страница 101: ...iconwillbe grey thenexttimeyouviewthisscreen Foradescriptionofthealarmsandnotifications seepage109 Overview of the Insulin and BG History Screens Toaccessyourinsulinandbloodglucoserecords navigateto M...

Страница 102: ...displayed Rangeofdays Toviewrecordsfromarangeofdates ortoquicklyfindadayfromweeksor monthsago 1 Navigateto Menuicon History Insulin BGHistory 2 Tapthedaterangeselector 3 Choose1 7 14 30 60or90daystose...

Страница 103: ...dglucosereadingswithinyourBG GoalRange BGsAbove Percentageofbloodglucosereadingsabovetheupper limitofyourBGGoalRange BGsBelow Percentageofbloodglucosereadingsbelowthelower limitofyourBGGoalRange Row2...

Страница 104: ...lusesfortheday oraverageforthedaterange Thisincludesboluses calculatedbytheBolusCalculatorandanymanually calculatedboluses Shownasapercentageofthetotal oraveragetotal insulin Alsoshowninunits Ifyoucan...

Страница 105: ...heindividualdaysin theselectedrange Thecolumnsshowthepercent ofbloodglucosereadings withintheBGGoalRange thetotaldailyinsulindeliveredandthetotaldaily gramsofcarbs Swipetosee morerecords Tapadown arro...

Страница 106: ...anyapplied tags Bolus details TheicondisplayedwithabolusentryindicateswhethertheBolusCalculatorwas used Theinsulinbottleicon indicatesthattheBolusCalculatorwasenabled Thesyringeicon indicatestheBolusC...

Страница 107: ...ntoriginallyscheduledfor delivery Foranextendedbolus theamount deliverednowandextended Alsothepercentage ofthemealbolus deliverednowandextended Ifabolusisongoing unconfirmedorlost howmuchofthebolushas...

Страница 108: ...lus thebasalandtotalinsulin amountsforthatdayarealsomarkedasunconfirmedwithayellowexclamation mark Thelistedbolusamountincludestheamountthatwasscheduledfor deliveryupuntilthePodwasdiscarded Carbs deta...

Страница 109: ...Insulin suspended and resumed details AnInsulinDeliverySuspendediconandbannerindicatethetimewhen aninsulinsuspensionbegan AnInsulinDeliveryResumediconandbannerindicatethetimewhen insulindeliverywasres...

Страница 110: ...ngnameagaintohidethedescription Note Somesettingshavedefaultvalues butallusersettingscanbechanged PDM Device Settings ThePDMDevicesettingsallowyoutocontrolnetworkconnectivity your personalidentificati...

Страница 111: ...nthebluedotoftheslider Slideyourfingertotheright toincreasethescreenbrightness Slideyourfingertothelefttodecreasethe screenbrightness Tip Lowerscreenbrightnessextendsthebatterycharge Lock screen Youca...

Страница 112: ...angethedateortime thechangeisnotedontheHomeandHistory screens ThePodexpirytimeonthePodInfotabisadjustedtoreflectthenewdate andtime YoucanalsochangethelanguageusedonthePDMscreens Dateanddateformat Toch...

Страница 113: ...andMinutefieldstothedesiredvalues Ifusing12 hr format selectbetweenamandpm 4 TapSAVE thentapCONFIRM 5 Ifyoususpendedinsulin tapYEStoresumeinsulindelivery Country TochangethePDM scountrysetting 1 Navig...

Страница 114: ...ebeepsandvibrationsworkedproperly tapYES Ifyoususpendedinsulin tocheckthealarms tapYEStoresumeinsulindelivery Warning IfthePDMfailstobeep callCustomerCareimmediately Ifan activatedPodfailstobeep chang...

Страница 115: ...ryourpersonalisedinformationorcallCustomerCareforassistance Pod Sites Setting ThePodSitessettingcontrolswhetheradiagramofthebodyisavailablewhenyou activateanewPod YoucanusethisbodydiagramduringPodacti...

Страница 116: ...osettheinsulinlevelforthelowreservoiradvisoryalarm 1 Navigateto Settingsicon Reminders LowReservoirLevel 2 TaptheLowReservoirLevelfieldandselectthelevelofPodinsulinatwhich youwouldliketobenotified 3 T...

Страница 117: ...olusoramanually calculatedbolusduringthemissedbolustimeperiod thePDMvibratesorbeeps anddisplaysareminder Youcansettimeintervalsfrom30minutesto4hours Youcansetuptosixmissedbolusremindersperday Note Toa...

Страница 118: ...desireddays Aselectedboxhasatick symbolinit 4 TaptheNobolusbetweenfieldandselectthestartofthemissedbolustime interval 5 Tapthenextfieldandselecttheendofthetimeinterval 6 TapSAVE Editamissedbolusremind...

Страница 119: ...rogramremindersonoroff 1 Navigateto Settingsicon Reminders 2 ScrolldownandtaptheProgramReminderstoggletoturnprogram remindersonoroff Note Youcannotturnoffbeepsthatoccurduringatempbasalsettodeliverno z...

Страница 120: ...inglereminders taptheReminderdatefieldandselectthedatefor thereminder Forrecurringreminders specifythedaysoftheweekbytappingtheboxes nexttothedaysyouwant Aselectedboxhasaticksymbolinit 4 TaptheReminde...

Страница 121: ...gsicon BloodGlucose BGGoalRange 2 SetthelimitsoftheBGGoalRange a TaptheUpperLimitfieldandenterthedesiredvalue Youcanalsotouch theupper yellow circleandslideitupordowntochangetheupperlimit b TaptheLowe...

Страница 122: ...activeBasalProgrambyaset percentageincreaseordecrease TapFlatRate U hr toreplacetheactiveBasalProgramwithafixed basalrateforthespecifiedduration c TapSAVE Bolus Delivery Settings Thesesettingsallowyou...

Страница 123: ...ancausehypoglycaemia TurntheBolusCalculatoronoroff ToturntheBolusCalculatoronoroff 1 Navigateto Settingsicon Bolus 2 TapthetoggleontheBolusCalculatorrowtoturnitonoroff 3 Ifthisisthefirsttimeyouhavetur...

Страница 124: ...touchthebluecircleandslideyourfingerupordowntheslidertoselectthe MinimumBGforCalcsvalue 3 TapSAVE InsulintoCarbRatio ICRatio Theinsulintocarbohydrateratio ICRatio defineshowmanygramsof carbohydratesar...

Страница 125: ...Factor c TapNEXT 5 Repeatthepreviousstepasneededfortheremainingsegments 6 Afterconfirmingthatallsegmentsarecorrect tapSAVE Note Youcanaddanddeletesegmentsbyeditingtheexistingsegments ReverseCorrection...

Страница 126: ...esthefollowingtypesofalarmsand messages Hazardalarmsarehigh priorityalarmsthatindicateaseriousproblemhas occurredandyoushouldremoveyourPod Advisoryalarmsarelower priorityalarmsthatindicatethatasituati...

Страница 127: ...see SilencinganAlarm onpage 123 Note IfatempbasalorextendedbolusisrunningwhenaPodhazardalarm occurs thePDMinformsyouthatitwascancelled Responding to Notifications Notificationsremindyouaboutactionstha...

Страница 128: ...esnotautomaticallyacknowledge or silence notifications AllnewnotificationsareincludedintheNotifications Alarmscount in theredcircleintheupperrightofmostscreens Toacknowledgethenotification 1 Wakeupyou...

Страница 129: ...d PodExpired LowReservoir EmptyReservoir Auto offalert Auto off Youcanpreventthesehazardalarmsbyrespondingtotheiradvisoryalarmina timelymanner Note Asanextraalert aPodExpiry notificationprecedesthePod...

Страница 130: ...youacknowledgethem See TimingofalarmsoriginatinginthePod onpage 134formoreinformation TheSound vibratebutton ThePDM sSound vibratebutton locatedontheupperrightedgeofthePDM controlswhetherthefollowingr...

Страница 131: ...hattodo TapOK DEACTIVATEPODNOW ChangeyourPod Checkyour bloodglucose Auto Off thePodhasstoppeddeliveringinsulinbecauseyoudidnot respondtotheAuto offadvisoryalarm BoththePodandPDMsoundthe alarm Tochange...

Страница 132: ...errorisdetectedinthePDM ThePDMsounds thealarm Message PDMerror RemovePodnow CallCustomerCare Ref referencenumber Whattodo TapOKtosilencethealarm RemoveyourPod CallCustomer Careimmediately Checkyourblo...

Страница 133: ...alue ThisescalatestotheEmptyReservoirhazardalarmifignored To changethisvalue see Lowreservoirlevel onpage 99 BoththePodandPDM maysoundthealarm Vibration tone Onceaminutefor3minutes Repeatsevery60minut...

Страница 134: ...essremaining Vibration tone None Topreservethebattery thePDMissilent Message LowPDMbattery PDMbatteryisgettinglow Rechargebattery soon Whattodo TapOK RechargeyourPDMbatteryassoonaspossible Caution The...

Страница 135: ...oeditthesereminders see CheckBGafterBolusreminders on page 100 Vibration tone Every5minutesuntilacknowledged Message Reminder CheckBG x hourshavepassedsinceyourbolus Whattodo Acknowledgethemessage see...

Страница 136: ...ndedbolusrunning Theseremindersareonbydefault Toturnthemonor off see Programreminders onpage 102 Podbeeps Onceevery60minuteswhileatempbasalorextendedbolusis running Podactivation Thesetonesorvibration...

Страница 137: ...cation thePDMandPodshouldbesidebysideduringactivation andwithin1 5metres 5ft afteractivation Anyinsulincommandwill initiateaconnectionbetweenthePDMandPod Communicationisdisruptedbyoutsideinterference...

Страница 138: ...ruction thePDMoffersyoudifferentoptions Theoptionsoffered dependonwhetherthePDMhassentthePodtheinstructionandhasn t receivedconfirmationthatitwascarriedout orwhetherthePDMhasn tsentthe instruction Ift...

Страница 139: ...PDMoffersthese options DISCARDPOD SelectthisoptiontotellyourPDMtounpairfromthatPod ThePDMinstructsyoutoremoveyourPodandtapCONTINUE TRYAGAIN Selectthisoptiontoattempttore establishcommunication Note Af...

Страница 140: ...nalarmissounding the alarmstops Youneedtoapplyenough forcetobreakathinlayerofplastic PDM alarm IfaPDMalarmisnotsilencedwhenyoutapthealarmscreen sbutton 1 PressandholdthePowerbutton thentapPoweroff 2 T...

Страница 141: ...124 Thispageintentionallyleftblank Effective Date 27SEP2019 ECO 000240...

Страница 142: ...ExtremeheatorcoldcandamagePodsandcausethemtomalfunction IfPodsare exposedtoextremetemperatures inspectthemcarefullybeforeuse Itisespeciallyimportanttostoreyourinsulininawell controlledenvironment Ins...

Страница 143: ...offthePodwithclean waterandgentlydryitwithatowel Warning DoNOTexposeyourPodtowateratdepthsgreaterthan7 6 metres 25feet orforlongerthan60minutes Cleaning your Pod Podsarewaterproof IfyouneedtocleanaPod...

Страница 144: ...ttingswillberetained PDM and the environment Avoidextremetemperatures ExtremeoperatingtemperaturescanaffectthePDM sbatteryandinterferewith OmnipodDASH Systemoperation AvoidusingthePDMintemperatures be...

Страница 145: ...Bcable WhenyouuseaUSBcabletouploadyourPDMrecordstoanotherdeviceorto chargeyourPDM disconnecttheUSBcableassoonasyouarefinished Caution OnlyconnectaUSBcabletoyourPDMwhenchargingthebatteryor transferring...

Страница 146: ...usesarechargeablelithiumionbattery Ifthereisaproblemwithyour batteryorcharger contactCustomerCareforinformationaboutreplacements Safe use of the PDM battery Warnings Donotexposeyourbatterytohighheat D...

Страница 147: ...erydeforms changescolouroroverheatswhilecharging during useorinstorage immediatelyremovethebattery Continuedusemayleadto batteryleakage fireorexplosion InspectyourPDMbatterychargerbeforeeachuse Ifthea...

Страница 148: ...PDMison turnitoffbypressingthePowerbutton tappingPoweroff andthentappingOK 2 IfthewhitepulltabisstillonthePDM removethebackcoverusingthepull tabasfollows a HoldthePDMwiththebackcoverfacingyou b Placet...

Страница 149: ...sidethebattery compartment 6 Slidethebatteryintoplace Gentlypushthe bottomofthebatterytofititintoplace 7 ToreplacethebackcoverofthePDM a Lineupthecover sedgealongthesidewiththeSound vibrateandPower bu...

Страница 150: ...er whichmeansthattheycanonly communicatewitheachotherevenifthereareotherPodsorPDMswithinrange DuringPodactivation thePDMtransferstheactiveBasalProgramdetailstothe Pod ThePDM scommunicationrangeisautom...

Страница 151: ...entbolus ThePodicononthestatusbarshowshowmuchinsulinremainsinthePod s reservoir see TheStatusBar onpage 9 TheLockscreenandafullscreenmessagedisplayinformationaboutPod alarms Timingofalarmsoriginatingi...

Страница 152: ...Pod WhenthePDMcannotresolveacommunicationerror thePDMisunableto deactivatethePod Inthissituation thePDMasksifyouwantto discard the Pod Discarding unpairsthePDMfromthatPodbutdoesnotstopthePod s insulin...

Страница 153: ...akeupyourPDM Thisresets thetimerandpreventsthealarmfromsounding Auto offalarms IfyouhavenotusedyourPDMwithintheamountoftimespecifiedbytheAuto offcountdowntimer thePodandPDMsoundanadvisoryalarmeverymin...

Страница 154: ...xample youcould deliveralowerrateofinsulinduringthenightandahigherrateduringtheday ThisfigureshowsaBasalProgramwiththreebasalsegments TocreatetheBasalProgramshownintheprecedingfigure thefollowingbasal...

Страница 155: ...rcise see UsingTemporaryBasalRates onpage 69 Tempbasalscanlastfrom30minutesto12hours Attheendofthespecifiedtime thePodautomaticallyrevertstotheactiveBasalProgram Tempbasalsettings Unitsperhour U hr or...

Страница 156: ...0 0 60 0 30 0 90 14 00 16 30 0 30 0 30x50 0 15 0 30 0 15 0 45 16 30 midnight 0 30 SegmentsaredefinedbythecurrentlyscheduledBasalProgram Tempbasalfrom07 00to16 30 BasalProgram Actualinsulindelivered mi...

Страница 157: ...flowratefor a basalsegmentis0 10U hrandyoucreateatempbasalwitha60 decreasefor Onehour theresultingflowrateof0 04U hrresultsinnoinsulinbeing deliveredfortheonehourdurationofthetempbasal Twohours theres...

Страница 158: ...olusinsulindelivery Nobasaldelivery Nobolusdelivery Nobasaldelivery Bolusesallowed Minimumduration forstoppinginsulin 30min 30min Maximumduration forstoppinginsulin 2hrs 12hrs Insulindelivery resumesa...

Страница 159: ...slowdowndigestionandthereforeslowdownthepost meal riseinyourbloodglucose About Manually Calculated Boluses Amanuallycalculatedbolusisabolusthatyouhavecalculatedwithout the help of theBolusCalculator Y...

Страница 160: ...ionboluscannotbeextended Acorrectionbolusisalwaysdeliveredfirst Inthefollowingexample threeunitsofinsulinareextended Totalbolus 5units 1unitcorrectionbolus 4unitsmealbolus Delivernow 2units 1unitcorre...

Страница 161: ...orCalcs setting Tenminutespass or Anewbloodglucosereading isaboveyourMinimumBG forCalcssetting IOBisdisplayedon theHomescreen Yourbloodglucose readingis HI Tenminutespass or Anewbloodglucosereading is...

Страница 162: ...sentstheamountoftimethatinsulin remains onboard or active inyourbody Note TheBolusCalculatoronlysubtractsIOBfromasuggestedbolusifyour currentbloodglucoseisknown Youshouldalwaystestyourbloodglucoseprio...

Страница 163: ...yourCorrectAbovesettings Ifyourbloodglucoseisabove therangeofyourBGmeterorisabove33 3mmol L thereadingisrecordedas HI andtheBolusCalculatorcannotcalculateabolus BolusCalculatordisabledabove33 3mmol L...

Страница 164: ...ionofInsulinActionof4hours Entirelymeal Amealbolusiscalculatedwhenyouare eatingamealandyourbloodglucoseisless thanyourCorrectAbovevalue TheIOB fromthisbolusisentirelymealIOB Entirelycorrection Acorrec...

Страница 165: ...reviouscorrectionbolus yourbody hasuseduponly1unitfromthecorrectionbolus Theremaining2units ofinsulinarestillinyourbodyworkingtocorrectyourbloodglucoselevel AccountingforcorrectionIOBinboluscalculatio...

Страница 166: ...ssubtracted Note Acorrectionbolusisneverreducedbelow0U Finalmealbolus prelim mealbolus remainingcorrectionIOB MealIOBisneversubtractedfromamealbolus Onlyaremainingcorrection IOBissubtractedfromamealbo...

Страница 167: ...omapreviouscorrectionbolus isthensubtractedfromthecurrentcorrectionbolus ifanyremains until thecorrectionbolusiszero Atthatpoint anyremainingcorrectionIOBis subtractedfromthecurrentmealbolus Thecalcul...

Страница 168: ...hanzero IfacorrectionIOB isgreaterthanthepreliminarycorrectionbolus subtractingonlypartofthe correctionIOBfromthepreliminarybolusbringsthecorrectionbolustozero The remainingcorrectionIOB istheamountof...

Страница 169: ...s See BolusCalculatorequations onpage 149forastep by stepdescriptionofthesecalculations Thepreliminarycorrectionboluscalculationsandwherethepreliminary correctionbolusesappearontheCalculationsscreen a...

Страница 170: ...argetBG 5 6 CorrectionFactor 2 8 8 4 5 6 2 8 1U MealIOBadjustment MealIOB 0U 1U 0U 1U NoIOB sonoIOBadjustment CorrectionIOBadjustment CorrectionIOB 0U 1U 0U 1U NoIOB sonoIOBadjustment MealBolus 3U You...

Страница 171: ...bolus MealIOBadjustment MealIOB 1U 1U 1U 0U However thispreliminary correctionbolusisreduced tozerobythe1UmealIOB adjustment CorrectionIOBadjustment CorrectionIOB 1U N A Correctionbolusis 0U Becauseth...

Страница 172: ...nbolusiszero BG 5 6 TargetBG 5 6 CorrectionFactor 2 8 5 6 5 6 2 8 0U MealIOBadjustment MealIOB 1U N A Correctionbolusis 0U Thecorrectionbolusiszero so themealIOBisnotsubtracted CorrectionIOBadjustment...

Страница 173: ...narycorrection bolus BG 8 4 TargetBG 5 6 CorrectionFactor 2 8 8 4 5 6 2 8 1U MealIOBadjustment MealIOB 0U 1U 0U 1U NomealIOB sonomealIOB adjustment CorrectionIOBadjustment CorrectionIOB 1U 1U 1U 0U Th...

Страница 174: ...ersubtractedfroma reversecorrection CorrectionIOBadjustment CorrectionIOB 0U N A Correctionbolusis 0U Nochangeinthereverse correctionbolusfortwo reasons IOBiszero andIOB isneversubtractedfroma reverse...

Страница 175: ...otalnumberofBGreadings Note ThesumandthetotaldonotincludeHIorLOblood glucosereadings BGin Range NumberofBGreadingswithinBGGoalRange x100 TotalnumberofBGreadings BGsAbove NumberofBGreadingsaboveBGGoalR...

Страница 176: ...veryovermultipledays thenumberofdaysinthe timeperioddoesnotincludedaysinwhichnoinsulin eitherbasalorbolus was delivered Forcalculationsoftotalcarbohydratesovermultipledays thenumberofdaysin thetimeper...

Страница 177: ...160 Thispageintentionallyleftblank Effective Date 27SEP2019 ECO 000240...

Страница 178: ...ptherapy Remember safeusebegins andendswithyou Ifyouhavequestionsordoubtsaboutbeingabletosafely usetheOmnipodDASH Systematanytime consultyourhealthcareprovider immediately Daily Activities Toensurepro...

Страница 179: ...changeyourPod Tip Considermakinginfusionsitecheckspartofyourdailyroutine likeshowering orbrushingyourteeth Check your blood glucose frequently Whenyouroutinelycheckyourbloodglucoselevel youcanidentify...

Страница 180: ...ets Glucosetabletsoranotherfast actingsourceofcarbohydrate Alcoholprepswabs Instructionsfromyourhealthcareproviderabouthowmuchinsulin to inject ifdeliveryfromthePodisinterrupted Asignedletterfromyourh...

Страница 181: ...rgencykitwithyouduringtripsorholidays see Prepare forEmergencies onpage163 Asitmaybedifficultorimpossibletogetinsulin orsuppliesinanunfamiliarplace takemoresuppliesthanyouthinkyou llneed Tip Whenyoutr...

Страница 182: ...ttheinsulinpumpcannotberemovedbecauseitisinserted withacatheter tubing undertheskin Checkyourairport swebsiteifyouhaveanyfurtherquestionsorconcerns Note PodsandPDMscansafelypassthroughairportX raymach...

Страница 183: ...Ifleftuntreated severe hypoglycaemiacancauseseizuresorleadtounconsciousness Ifyoususpectthat yourbloodglucoselevelislow checkyourbloodglucoseleveltoconfirm Symptomsofhypoglycaemia lowbloodglucose Neve...

Страница 184: ...chyourfriends familymembersandcolleaguestorecognisethesignsof hypoglycaemia sotheycanhelpifyoudevelophypoglycaemiaunawareness orasevereadversereaction Keepaglucagoninjectionkitwithyouremergencysupplie...

Страница 185: ...CRatio Consultyourhealthcareprovideraboutrefining thesesettingsasneeded Pronetosevere hypoglycaemia orhypoglycaemia unawareness Consultyourhealthcareproviderabout hypoglycaemiaunawarenessandaboutraisi...

Страница 186: ...l andfollowthetreatmentguidelinesestablishedbyyourhealthcareprovider Hyperglycaemiacouldresultifappropriateactionsarenottaken Tip Hyperglycaemiasymptomscanbeconfusing Alwayscheckyourbloodglucose befor...

Страница 187: ...wing Takeasecondbolusbyinjection usingasterilesyringe Askyourhealthcare providerwhethertoinjectthesameamountofinsulinasinstep3 ReplacethePod UseanewvialofinsulintofillthenewPod Thencontact yourhealthc...

Страница 188: ...ctbolus timing orbolustoosmall Checkcarbintake Takeboluswithfood Checkbloodglucosebeforegivingamealbolus If necessary adjustthebolus Consultyourhealthcareproviderforguidance High proteinorhigh fatmeal...

Страница 189: ...tuntreated DKAcancausebreathingdifficulties shock comaand eventuallydeath Ifyouneedemergencyattention askafriendorfamilymembertotakeyou totheAccidentandEmergencydepartmentorcallanambulance Donot drive...

Страница 190: ...vidercanhelpyoumakeaplanforsickdays The followingareonlygeneralguidelines Whenyouareill checkyourbloodglucosemoreoftentoavoidDKA The symptomsofDKAaremuchlikethoseoftheflu Beforeassumingyouhavethe flu...

Страница 191: ...nremoved Tip Ifpossible planremovaltimestocoincidewithascheduledPodreplacement IfyouwillneedtoremovethePodformorethanonehour askyourhealthcare providertorecommendappropriateguidelines X rays MRIs and...

Страница 192: ...intsto RecoveryMode ThenpresstheSound VibrateDOWN VOLUME_DOWN buttontoselect RecoveryMode Caution Donotselectthe FastbootMode becauseitwillstopthePDM fromresponding IfthePDMstopsresponding removetheba...

Страница 193: ...oU hr Range 0U hrtoMaximumBasalRateinincrementsof 0 05U hr Tempbasalpresets Maximumof12 BGGoalRangefor bloodglucosehistory Lowerandupperlimits 3 9to11 1mmol Lin 0 1mmol Lincrements BGreminder OnorOff...

Страница 194: ...Pod Specifications Size 3 9cmwidex5 2cmlongx1 45cmhigh 1 53 x2 05 x0 57 Weight withoutinsulin 26grams 0 92oz Operatingtemperaturerange Podoperatingenvironmentof5 Cto40 C 41 Fto104 F Note ThePodtempera...

Страница 195: ...Uper hour BolusRate 1 5unitsperminute Doserangefrom0 05to30 0units Deliveryaccuracy testedperIEC60601 2 24 Basal 5 atrates 0 05U hr Bolus 5 foramounts 1 0unit 0 05unitsforamounts 1 0unit Note Theusers...

Страница 196: ...uching eitherinoroutofthetray toensure propercommunicationduringpriming Duringnormaloperation Within1 5m 5ft ofeachother Dependingon thelocation thecommunicationdistancemayhandleseparationsofupto15 me...

Страница 197: ...es occludedwhendeliveringa5Ubolus 35minutesmaypassbeforethePodsounds ahazardalarm TimebetweenocclusionandPodalarm Typicaltime Maximumtime 5 00Ubolus 33minutes 35minutes 1 00U hrbasal 3 0hr 5 5hr 0 05U...

Страница 198: ...Serialnumber Storageatmospheric pressure Operational atmosphericpressure 2 Submersible Waterproofto7 6 metres 25feet for upto60minutes Non pyrogenicfluid path 22 Avoidliquid Authorised Representativei...

Страница 199: ...ipodDASH InsulinManagementSystem boththePodandthePDM complieswithPart15oftheFederalCommunicationsCommission FCC Rules Operationissubjecttothefollowingtwoconditions 1 Thesedevicesmaynotcauseharmfulinte...

Страница 200: ...usceptibleto interference GeneralNotes Medicalelectricalequipmentrequiresspecialprecautionsregarding electromagneticcompatibility EMC andneedstobeinstalledandputinto serviceaccordingtotheEMCinformatio...

Страница 201: ...tisusedinsuchanenvironment Emissions Compliance accordingto Electromagneticenvironment RFEmissions CISPR11 Group2 ThePodandthePDMemitlow level electromagneticenergy RF inorderto communicate Althoughun...

Страница 202: ...alrecipientoftheOmnipodDASH InsulinManagementSystemforusein Europe that ifInsuletdeterminesthatyourPersonalDiabetesManager PDM hasadefect inmaterialorworkmanshipwhileutilisedundernormaluseandcondition...

Страница 203: ...hippingthePodorthePDMtoInsuletunderthis Warranty Fortheavoidanceofdoubt thisWarrantydoesnotcoverrepairsperformedor replacementsprovidedbyanypersonorentityotherthanInsulet exceptthoseperformedor provid...

Страница 204: ...Omnipod Systemfor anyspecificpersonashealthcareandtreatmentarecomplexsubjectsrequiringtheservicesof qualifiedhealthcareproviders ThisWarrantyisbetweenyouandInsulet Nootherpartyhasanyrightstoenforceany...

Страница 205: ...obligationsarisingoutoforinconnectionwithit is governedbythelawsofyourcountryofresidence Anycourtofcompetentjurisdictioninyour countryofresidencewillhaveexclusivejurisdictionandvenueforanydisputearisi...

Страница 206: ...ucosevalues Thisrange isusedinthehistoryrecordstoshowwhichbloodglucosevaluesfallwithinthis range Bloodglucose Bloodglucoselevel Theamountofglucose orsugar inthe blood Bloodglucosemeter Adeviceusedtoch...

Страница 207: ...touse insulincorrectly Diabeticketoacidosis DKA Aseriousconditioninwhichextremelyhigh bloodglucoselevelsandaseverelackofinsulincausethebodytobreakdownfat andproteinforenergy Thebreakdownoffatorprotein...

Страница 208: ...stopped Alarms requireyourimmediateattention Healthcareprovider Aprofessionalwhopractisesmedicineorteachespeople howtomanagetheirhealth Hyperglycaemia highbloodglucose Ahigher than normallevelofglucos...

Страница 209: ...almessage Occlusion Ablockageorinterruptionininsulindelivery Pairing Linkingtwodevicessothattheycancommunicatewirelesslywitheach other Seealsosync Podders Peoplewithdiabetesorcaregiversofpeoplewithdia...

Страница 210: ...nsulinadjustments Tempbasalpreset Anadjustmentinabasalrate ineither orU hr thatcanbe assignedacustomnameandstoredbythePDMforlateruse Timesegment seesegment Unconfirmedbolus OccurswhenyouselecttheDISCA...

Страница 211: ...194 Thispageintentionallyleftblank Effective Date 27SEP2019 ECO 000240...

Страница 212: ...rylic adhesive 37 aseptic technique 40 Auto off alarm 114 116 description 136 setting 99 B basal history records 86 92 Basal Program about 137 activate 72 create 75 delete 78 edit 77 override See temp...

Страница 213: ...screen 94 C cancel bolus 66 temp basal 71 cannula 2 48 177 carbohydrate bolus See Bolus Calculator carb to insulin ratio See IC Ratio care infusion site 49 PDM 126 Pod 125 change Basal Program 72 Pod...

Страница 214: ...food bolus See Bolus Calculator forgotten PIN 11 G glucagon kit 163 167 H hazard alarms 114 115 history records alarms 83 and date change 92 and time change 92 blood glucose 86 92 carbs 86 92 insulin...

Страница 215: ...ount 41 meal bolus See Bolus Calculator meal IOB 143 148 Menu 17 18 microwave ovens 128 Minimum BG for Calcs 107 145 minimum insulin amount 41 missed bolus notification 118 setting 100 mobile phones 1...

Страница 216: ...checks xv setup 37 50 site selection 44 47 specifications 177 storage 125 Pod error alarm 114 Pod expired alarm 114 116 Pod Info tab 12 Pod site map 44 98 prepare infusion site 46 preset bolus create...

Страница 217: ...Correction 108 screen brightness 94 screen time out 94 summary 176 Target BG 106 temp basal 105 temp basal preset 79 time 95 96 shorthand for navigation 8 shut off alarm 123 sick days 173 site select...

Страница 218: ...ity 4 time out 94 travel 164 165 Troubleshooting PDM start up 175 U U 100 insulin xii unconfirmed bolus 91 unlock PDM 10 upper limit BG Goal Range 104 USB cable 128 user calculated bolus See manually...

Страница 219: ...updateyourinformationifyouchangeoraddPDMsettings Basal Program 1 Name_______________ Basalrate midnight to U hr to U hr to U hr to U hr to U hr to U hr to U hr Basal Program 2 Name_______________ Bas...

Страница 220: ...nsulin decreasesBGby midnight to mmol L to mmol L to mmol L to mmol L to mmol L to mmol L to mmol L to mmol L Duration of Insulin Action Timethatinsulinremains active inthebodyafterabolus hrs Temp Bas...

Страница 221: ...My Notes Effective Date 27SEP2019 ECO 000240...

Страница 222: ...ks or registered trademarks of Insulet Corporation in the United States of America and in various others jurisdictions All rights reserved Reference number PDM INT2 D001 MM PT 000002 GBR ENG MM AW Rev...

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