OmniPod UST400 User Manual Download Page 1 | Manualshive

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OmniPod UST400 User Manual Download Page 1

INSULIN MANAGEMENT SYSTEM

www.myomnipod.com

*Up to 72 hours of insulin delivery

U

SER

GUIDE

E

NT45

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SER

GUIDE

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NT4

50

Podder’s handbook

INSULIN MANAGEMENT SYSTEM

© 2012-2017 Insulet Corporation. Omnipod and the Omnipod logo are
trademarks or registered trademarks of Insulet Corporation in the United States
of America and other various jurisdictions. All rights reserved.
Patent information at www.insulet.com/patents.
Printed in USA.

PDM imagery is for illustrative purposes only.

PDM screens may vary based on model or user settings.
Model: ENT450
**IPX8 up to 25 feet for 60 minutes – PDM not waterproof

17845-5C-AW Rev A 10/17

Insulet Corporation

600 Technology Park Drive, Suite 200

Billerica, MA 01821 USA

Support/Supplies: 0800 011 6132 | [email protected]

Welcome, Podder !

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Summary of Contents for UST400

Page 1: ... Up to 72 hours of insulin delivery USER GUIDE ENT450 USER GUIDE ENT450 Podder s handbook INSULIN MANAGEMENT SYSTEM ...

Page 2: ...on 600TechnologyParkDrive Ste200 Billerica MA 01821 USA PDMModel ENT450 SerialNumber __________________________________________________ Omnipod InsulinManagementSystemStartDate _____________________ Healthcare Provider Nurse Educator Name Name Address Address Phone Phone Email Email Health Insurance Pharmacy Name Name Address Address Phone Phone PolicyNumber Email ...

Page 3: ...sdictions Allrightsreserved Patentinformationatwww insulet com patents FreeStyleandrelatedbrandmarksaretrademarksofAbbottDiabetesCareInc in variousjurisdictionsandusedwithpermission Allothertrademarksarethepropertyoftheirrespectiveowners Theuseofthird partytrademarksdoesnotconstituteanendorsementorimplyarelationshipor otheraffiliation 17845 5C AWRevA 09 17 ...

Page 4: ... TheHome Powerbutton 4 TheUp Downbutton 4 Softkeysandsoftkeylabels 4 TheInfobutton 5 Screenbrightness 5 Navigationshorthand 5 DataEntry 6 Enteringnumbers 6 Enteringtext 6 TheHeaderBar 7 PDMbatterylevelindicator 7 Moreinfoindicator 7 Insulinlevelindicator 7 Timeanddate 7 ThePDM sTop levelScreens 8 IDscreen 8 HomescreenandMoreactionsscreen 9 Statusscreen 10 IOBscreen 11 2 InitialPDMSetup 13 PDMSetup...

Page 5: ...usionSite 32 AvoidInfusionSiteInfections 33 MoreInformationaboutPodUse 34 4 CheckingYourBloodGlucose 35 AboutBloodGlucoseTesting 35 UsingtheBuilt inBGMeter 37 InsertateststripintothePDM 37 Testyourbloodglucoseorcontrolsolution 39 Controlsolutionresults 41 Bloodglucoseresults 42 Using BGMeter 44 TaggingtheBloodGlucoseResults 45 5 DeliveringaBolusofInsulin 47 WhyBolus 47 BolusingwiththeBolusCalculat...

Page 6: ...ttons 63 Screentime out 63 Backlighttime out 63 Factorydefaultssettings 64 BasalandTempBasalSettings 64 MaximumBasalRate 64 BasalPrograms 65 Tempbasalconfiguration 68 Tempbasalpresets 68 BolusCalculatorSettings 70 TurntheBolusCalculatoronoroff 70 TargetBGandCorrectAbovevalue 70 MinimumBGforCalcs 71 ICRatio 71 CorrectionFactor 72 ReverseCorrection 72 Durationofinsulinaction 72 Carbpresets 73 BolusD...

Page 7: ...ryRecords 90 ViewBGrecordsforoneday 90 ViewBGrecordsformultipledays 91 AlarmHistoryRecords 92 CarbohydrateHistoryRecords 92 CombinedListingofAllHistoryData 93 MyInfo 93 Reference 9 Alarms Notifications andOtherMessages 95 Overview 95 HazardAlarms 96 AdvisoryAlarms 98 Notifications 99 InformationalBeeps 101 PodCommunicationFailures 102 FailuretoreceiveaPodstatus 102 Failurewhenactivatingorsendingac...

Page 8: ...cose 121 Hyperglycemia highbloodglucose 126 Diabeticketoacidosis DKA 129 HandlingSpecialSituations 130 Sickdays 130 Exercising playingsports orworkinghard 131 X rays MRIs andCTscans 131 Surgeryorhospitalization 131 12 UnderstandingPDMandPodFunction 133 PDMandPodInteractions 133 PodactionscontrolledbythePDM 133 WhatthePodcandobetweenPDMinstructions 136 PDM sself checks 137 Auto off 137 BasalInsulin...

Page 9: ...s 158 ProtectionfromOver infusionorUnder infusion 159 SystemAccuracyaccordingtoInternationalStandard ISO15197 2013 160 PDMIcons 161 Omnipod SystemLabelSymbols 162 MedicalDeviceDirective 163 Omnipod SystemNoticeConcerningInterference 163 WarrantyforthePDMandPods 168 WARRANTYFORTHEOMNIPOD INSULINMANAGEMENTSYSTEM PERSONALDIABETESMANAGERANDPODS UnitedKingdomandIreland 168 WARRANTYCOVERAGE 168 Glossary...

Page 10: ...ideisnotasubstitute formedicalorhealthcareadvice recommendationsand orservicesfroma qualifiedhealthcareprovider Thisuserguidemaynotberelieduponinanyway inconnectionwithyourpersonalhealthcare relateddecisionsandtreatment Allsuchdecisionsandtreatmentshouldbediscussedwithaqualifiedhealthcare providerwhoisfamiliarwithyourindividualneeds ThisUserGuideisperiodicallyupdated VisittheLearningCentersectiono...

Page 11: ...coseinfreshwholecapillary bloodfromthefinger upperarmandpalm AbbottFreeStyleControlSolutionsareusedtoverifythatthemeterandteststrips areworkingtogetherproperlyandthatthetestisperformedcorrectly Contraindications InsulinpumptherapyisNOTrecommendedforpeoplewhoare Unabletoperformatleastfour 4 bloodglucosetestsperday Unabletomaintaincontactwiththeirhealthcareprovider UnabletousetheSystemaccordingtoins...

Page 12: ...racticethe bloodglucosetestingproceduresbeforeusingtheSystem Monitoryour bloodglucosewiththeguidanceofyourhealthcareprovider Undetected hyperglycemiaorhypoglycemiacanresultwithoutpropermonitoring Warnings Personalhealthconsiderations Notrecommendedforindividualswithhearingloss Alwaysverifyyour abilitytohearPod PDMalarmsandnotifications IfyouareunabletousetheSystemaccordingtoinstructions youmaybe p...

Page 13: ...ctions anddecompressionsickness Caution Thisdeviceisintendedforself testingbytheuser Caution Ifyouarehavingsymptomsthatarenotconsistentwithyourblood glucosetestresultsandyouhavefollowedallinstructionsdescribedinthis UserGuide callyourhealthcareprovider Safe Use Pumptherapyrequiressubstantialcaregiverinvolvement especiallywith children Workwithyourhealthcareprovidertoestablishdiabetesmanagement gui...

Page 14: ...ustbecomeactivelyinvolvedinyourowndiabetesmanagement toenjoythecontrol freedomandflexibilitythatispossiblewiththeOmnipod System Beingactivelyinvolvedmeans Frequentlymonitoringyourbloodglucoselevels LearninghowtooperateyourOmnipod Systemandpracticingproper techniques Visitingyourhealthcareprovider Safety Features TheOmnipod System sbuilt insafetyfeaturesinclude Automaticpriming safetychecks andinse...

Page 15: ...rnotificationmessage Note ActivateyourPDMperiodicallytoconfirmthattherearenonotifications oralarmsthatrequirearesponse Warning DoNOTattempttousetheOmnipod Systembeforeyou receivetrainingfromyourOmnipod SystemTrainerorhealthcareprovider Inadequatetrainingcouldputyourhealthandsafetyatrisk ...

Page 16: ...meterandentertheresultsmanually intothePDM Recordkeeping ThedatastoragesysteminthePDMdisplaysupto90daysof information Thisincludesbloodglucoseresults basalratesandbolusdoses carbohydrates andalarms TheGettingStartedsectionofthisbookexplainsthebasicoperationandsetupof theOmnipod System TheUserGuidesectiongivesstep by stepinstructionsfor usingtheSystem TheReferencesectionexplainstheSystemindetail Te...

Page 17: ... controlthePod ThePod ThePodisalightweight self adhesivedevicethatyoufillwithinsulin andweardirectlyonyourbody ThePoddeliversinsulinintoyourbodythrougha smallflexibletubecalledacannula basedoninstructionsfromthePDM ThePodisappliedtoyourskinwithanadhesive similartoanadhesivebandage Podneedlecap Viewingwindow Papercoverfor adhesivebacking Housingvent Fillport Adhesivebacking Bottom Top ...

Page 18: ...lddevicethat WirelesslyprogramsthePodwithyourpersonalizedinsulin delivery instructions WirelesslymonitorsthePod soperation Includesabuilt inbloodglucosemeter Up Downbutton Teststripport Home Power button Info button Softkey Softkeylabel Home Screen USBport Headerbar ...

Page 19: ...n thescreen UsetheUp Downbuttontoscrolldowntoviewany off screentext PresstheUparrow theupperpartoftheUp Downbutton toincreaseanumber ortomoveuponascreen PresstheDownarrow thelowerpartoftheUp Down button todecreaseanumberormovedownonascreen Soft keys and soft key labels Softkeylabelsappearonthescreendirectlyabovethesoftkeybuttons Thesoft keylabelsdifferondifferentPDMscreens Pressasoftkeytoselectana...

Page 20: ...toncanalsobeusedtomakeyourPDMscreenbrighterorlessbright PressandholdtheInfobuttonfortwosecondstotogglethe brightmode onor off Tocontrolthedimmingofthescreen see Backlighttime out onpage63 Navigation shorthand TheUserGuideusesthe symboltoindicatenavigatingfromonescreento another Forexample thefollowingnotation Home Settings Presets Carbpresets tellsyouto 1 TurnonthePDMandconfirmyourID ifnecessary 2...

Page 21: ...edesthe a andfollowsthe Z ofthealphabet Numbersandafewothercharacters suchas and arefoundfollowingthe alphabetandthespacecharacter 2 Pressthemiddlesoftkey labeledwiththerightarrow tomovethe underscoretothenextcharacter 3 Entereachcharacteroneatatime Anup and down arrowsymbolonthe screenindicatesthecharacteryouarecurrentlychanging Forexample toenterausernameof MKC2 5 10 usetheUp Downbuttonand themi...

Page 22: ...alffull 1 4full Empty See ReplacingthePDM sbatteries onpage112formoreinformation More info indicator The moreinfo indicatorisfoundontheheaderbarofsomescreens see TheInfobutton onpage5 Insulin level indicator TheinsulinlevelindicatorisfoundontheStatusscreen sheaderbaronly The headerbardisplaystheamountofinsulinremainingasfollows Displayinheaderbar Unitsofinsulinremaining 50 U Anyamountabovea50unitt...

Page 23: ...olusandbloodglucoseinformation anddisplaysmessages TheIOBscreengivesdetailsabouthowmuchinsulinisactiveinyourbody ID screen TheIDscreenperformsaveryimportantfunction It allowsyoutoidentifythePDMasyours ToconfirmthatthePDMisyours 1 PresstheHome Powerbuttontoturnonyour PDM TheIDscreenappears Verifythatthe usernameisyours 2 PressConfirm TheStatusscreenappears IntheremainderofthisUserGuide instructions...

Page 24: ...een page9 Tempbasal Defineatemporarybasalrate thismenu itemdoesnotappearifthetempbasal featureisturnedoff see Tempbasal configuration onpage68 page55 Myrecords Viewhistoryofinsulindelivery blood glucosereadings carbseaten andalarms page85 Settings CreateandeditBasalProgramsandpresets andcustomizeyoursettings including soundorvibration page61 Suspend Suspend cancel orresumeinsulindelivery page59 Ch...

Page 25: ... see Failuretoreceivea Podstatus onpage102 TheStatusscreenshows The header bar see The Header Bar on page7 YourmostrecentBGreadingandthetime anddateitwasrecorded Your most recent bolus and the time and datedeliverybegan Your insulin on board or IOB insulin from boluses still active in your body if the Bolus Calculator is on see Turn the BolusCalculatoronoroff onpage70 Message about the Pod s curre...

Page 26: ...Fordetailsaboutyourinsulinonboard IOB navigate totheStatusscreenandpresstheInfobutton TheIOBscreenshowsyouhowmuchofyourtotalIOB isfromamealIOBandhowmuchisfromacorrection IOB FormoreinformationabouttheIOBcalculationand howtheBolusCalculatorusesIOB seepage145 ...

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Page 28: ... HeorshewillhelpyouinitializethePDM basedonyourindividualneeds Inadequatetrainingorimpropersetupcould putyourhealthandsafetyatrisk Note Keepanemergencykitwithyouatalltimestoquicklyrespondtoadiabetes emergency ItemstobringtothemeetingwithyourOmnipod Systemtrainer YourPDM TwoPods FreeStyleTestStripsandControlSolution andalancingdevice available frommanypharmacies ThisUserGuide Instructionsfromyourhe...

Page 29: ...ntothecompartment Thediagram insidethecompartmentshowsyouwhichdirectiontoinsertthebatteries Caution OnlyuseAAAalkalinebatteriestopowerthePDM Neveruseold used ornon alkalinebatteries thePDMmaynotworkproperly Donotuse rechargeablebatteries 3 Replacethebatterydoor 4 TurnthePDMfaceup ThePDMpowersonautomatically Personalize your PDM Usernameandscreencolor 1 Afterinsertingthebatteries aWelcomemessageapp...

Page 30: ...eliverinsulinatabasalratethatexceedsyour MaximumBasalRate YoucanadjustyourMaximumBasalRatelater ifyour needschange 1 UsetheUp DownbuttontochooseaMaximumBasalRate 2 PressNext DefineaBasalProgram YourBasalProgramdefinesyourdailyscheduleforcontinuousinsulindelivery TheinitialBasalProgramisnamed basal1 andcoversthefull24 hourperiod frommidnighttomidnight Foranexplanationofbasalrates basalsegmentsand B...

Page 31: ...avetostoretheBasalProgram Note YoucanrenamethisBasalProgramorcreateadditionalBasalPrograms aftersetupiscomplete see BasalPrograms onpage65 Tempbasalconfiguration Foranexplanationaboutusingtemporarybasalrates calledtempbasals see Temporarybasalrates onpage139 1 Chooseaconfigurationforyourtempbasals Todefineyourtempbasalsasapercentageofthecurrentlyactive BasalProgram U hr Todefinetempbasalsasaflatra...

Page 32: ...tOfftodoyourownboluscalculations 2 PressNext IfyouturnedtheBolusCalculatoroff skipto Otherbolus settings onpage20 TargetBGandCorrectAbovevalues TheBolusCalculatoraimstobringyourbloodglucosetotheTargetBGvalue You canestablishuptoeightdifferentbloodglucosetargetsatdifferenttimesofday ForeachTargetBGthatyouset youalsosetanaccompanyingCorrectAbove value TheCorrectAbovevaluecanrangefromtheTargetBGto11 ...

Page 33: ...ssNext ICRatio YourInsulin to CarbohydrateRatio ICRatio defineshowmanycarbohydrates canbehandledbyoneunitofinsulin TheBolusCalculatorusestheICRatioto calculatethemealportionofasuggestedbolus YoucancreateuptoeightICRatio segmentsperday 1 UsetheUp DownbuttontoentertheICRatioforthetimesegmentthat startsatmidnight YourICRatiomustbebetween1 150gcarb unitinsulin PressNext 2 Ifdesired addmoretimesegments...

Page 34: ...Factorprofile for step by stepinstructions see Addingtimesegments onpage19 3 Whenthedesirednumberoftimesegmentsexist pressDone 4 ReviewthegraphofyourCorrectionFactorprofile PressListforalisting PressGraphtoseethegraphagain 5 PressSavetostoretheprofile Adding time segments 1 Choose addnew andpressNew Note YoucaneditanexistingsegmentbyusingtheUp Down buttontoselectasegmentyouwishtochangeandpressingE...

Page 35: ...ingtoyourcurrentbloodglucosevalue 2 PressNext Durationofinsulinaction Thedurationofinsulinactionisthelengthoftimethatinsulinstaysactivein yourbody TheBolusCalculatorusesthissettingtodeterminehowmuchinsulin remainsinyourbodyfrompreviousboluses calledinsulinonboard 1 UsetheUp Downbuttontoselectyourdurationofinsulinaction 2 PressNext Other bolus settings Bolusincrement Thebolusincrementdefineshowmuch...

Page 36: ...ePod runninglowoninsulinoranupcomingPodexpiration 1 UsetheUp Downbuttontoselecttheinsulinlevelatwhichyouwouldliketo receivea lowreservoir message Thisvolumecanrangefrom10to50units PressNext 2 UsetheUp Downbuttontospecifyhowmuchadvancewarningyouwant aboutanupcomingPodexpiration Thissettingcanbefrom1to24hours PressNext Activate Your First Pod Congratulations YourPDMisnowreadyforuse ToactivateaPodnow...

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Page 38: ...rsetupcouldputyourhealthandsafetyatrisk BecausethePodusesonlyrapid actingU 100insulin youareatincreased riskfordevelopinghyperglycemiaifinsulindeliveryisinterrupted Severe hyperglycemiacanquicklyleadtodiabeticketoacidosis DKA DKAcan causesymptomssuchasbreathingdifficulties shock coma ordeath If insulindeliveryisinterruptedforanyreason youmayneedtoreplacethe missinginsulinusuallywithaninjectionofra...

Page 39: ...lyoruseaPodifthesterilepackagingisopenordamaged or ifthePodhasbeendroppedafterremovalfromthepackage asthismay increasetheriskofinfection Podsaresterileunlessthepackaginghasbeen openedordamaged DoNOTapplyoruseaPodthatisdamagedinanyway AdamagedPodmay notworkproperly DoNOTuseaPodifitispasttheexpirationdateonthepackage Tominimizethepossibilityofsiteinfection doNOTapplyaPodwithoutfirst usingaseptictech...

Page 40: ...atriskofover infusionandpossiblehypoglycemia 4 Whendeactivationiscomplete removethe deactivatedPod a Gentlylifttheedgesoftheadhesivetapefrom yourskinandremovetheentirePod Tip RemovethePodslowlytohelpavoidpossible skinirritation b Usesoapandwatertoremoveanyadhesivethat remainsontheskin or ifnecessary usean adhesiveremover c Checktheinfusionsiteforsignsofinfection See AvoidInfusionSiteInfections onp...

Page 41: ... Securelytwistthefillneedleontothefillsyringe 3 Pulloutwardtoremovetheprotectivecapfrom theneedle Savethecap youwillneeditlater 4 Determinehowmuchinsulinyouwillputinto thePod Forexample tousethePodfor48 hours determinehowmuchinsulinyouwill useoverthenext48hours Yourhealthcare providercanhelpyoudeterminethecorrectamount Note ThePodrequiresaminimumof85unitsofU 100insulintobegin operation ThePodcanho...

Page 42: ...efill syringeintothePodmayresultininterruptedinsulindelivery 9 Removetheneedlefromthevial Fill and Activate a Pod Warning BeforefillingaPod ensurethatnootherPodsarebeingactivated within61cm 24inches ofyourPDM Thispreventsactivationofthewrong Pod Caution Besuretoinsertthefillsyringeintothefillportandnotatanyother locationonthePod Donotinsertthefillsyringemorethanonceintothefillport Onlyusethefillsy...

Page 43: ...willnotleakaftertheneedleisremoved 6 Placetheprotectivecapbackontheneedleandremovetheneedlefromthe fillsyringe 7 PlacethePDMnexttothePodsotheyare touching ThePodcanbeinitsplastictray duringthisprocess 8 PressNext Ascreenappearstellingyouthat thePodispriming 9 TheOmnipod Systemperformsaseriesofsafety checksandautomaticallyprimesthePod Listenfor thebeepsthatindicatethatthePodissuccessfully activated...

Page 44: ...siteswherethePodwillbeaffectedbyfoldsofskin AvoidplacingthePodoveramole tattooorscar whereinsulinabsorption maybereduced Avoidareasoftheskinwithanactiveinfection Prepare the Infusion Site Toreducetheriskofinfectionattheinfusionsite 1 Washyourhandswithsoapandwater 2 WashyourselectedPodsitewithsoapandwater Note Antibacterialsoapmayirritateskin especiallyattheinfusionsite Ask yourhealthcareproviderho...

Page 45: ...ll 2 Ifanyofthefollowingapply pressDiscard andthendisposeofthePodand beginagainwithanewPod a ThePodisaccidentallydropped asthismaycompromisesterility b ThePodoritsadhesivepadiswet dirtyordamaged c ThecannulaextendsbeyondtheadhesivebackingwhenthePodneedle capisremoved Warning Verifythatthecannuladoesnotextendbeyondtheadhesive backingoncetheneedlecapisremoved 3 Usingthepulltabs removeanddiscardthewh...

Page 46: ...orone timeuse OnceaPodisplacedonyourbody youcannotmovethatPodtoanothersite Note ThePod sadhesivekeepsitsecurelyinplace forupto3days However ifnecessary several productsareavailabletoenhanceadhesion Ask yourhealthcareproviderabouttheseproducts Avoidgettingbodylotion creams oroilsnear theinfusionsiteastheseproductsmayloosenthe adhesive 7 PressNext Up down orslightangle Horizontalordiagonal Suggested...

Page 47: ...elivering thebasalrateofinsulinaccordingtotheactiveBasal Program ThecannulacanbeinsertedonlyoncewitheachPod Caution Besuretocheckthealarmfunctionatevery Podchange see Check thealarmsandvibration on page63 Check the Infusion Site Followinginsertionofthecannula checktheinfusionsite 1 Lookthroughtheviewingwindowtocheckthat thecannulaisinsertedintotheskin Thecannula istintedlightblue 2 Checkforpinkcol...

Page 48: ...tusscreen 6 After1 5hours thePDMpromptsyoutocheckyourbloodglucoseleveland torechecktheinfusionsite Warning NEVERinjectinsulin oranythingelse intothefillportwhile thePodisonyourbody Doingsomayresultinunintendedorinterrupted insulindelivery Avoid Infusion Site Infections Checktheinfusionsiteatleastonceaday Beawareofsignsofinfection includingpain swelling redness discharge or heatatthesite Ifyoususpe...

Page 49: ...urs whichevercomesfirst Developaroutinesoyoucanchange yourPodataconvenienttime Ifyouknowofanupcomingbreakinyourroutine thatcouldinterferewithchangingyourPod youcanchangeyourPodearlytoavoid disruptionininsulindelivery ForadditionalinformationonusingyourPodsaseffectivelyaspossible seethe followingsections ForcareofyourPod see PodandInsulinCare onpage109 TolearnaboutthePodalarms see Alarms Notificati...

Page 50: ...dothertestsitessuchas theforearm upperarmandhand Youmayseedifferencesinbloodglucose measurementsbetweentheothertestsitesandyourfingeraftereating taking insulinmedication orexercise Youmayseechangesinbloodglucoseinbloodsamplesfromthefinger soonerthaninbloodsamplesfromalternatesites Vigorousrubbingofthe alternatetestsitesbeforelancinghelpstominimizethesedifferences Measurementsobtainedfromsitesother...

Page 51: ...eStyleControlSolutionisaredliquidcontainingafixedamountof glucose ItisavailableinLow Normal andHighconcentrations Usecontrol solutiontoensurethatyourmeterandteststripsareworkingtogetherproperly andtopracticetestingwithouthavingtouseyourownblood Seethecontrol solutioninstructionsforinformationabouthandlingandstoringthecontrol solution Youshouldperformacontrolsolutiontestwhen Yoususpectthatthebuilt ...

Page 52: ...tstrippackageinsert Pleasereadallinstructionsprovidedontheteststrippackageinsertbeforeusing theOmnipod SystemandFreeStyleaccessories Insert a test strip into the PDM 1 TurnonyourPDMbypressingtheHome Powerbutton IdentifythePDMasyoursand pressConfirm Tip YoucanalsoturnonthePDMby insertingtheteststripintotheteststripport Caution IfAuto offisenabled youshould alwaysturnonthePDMwiththeHome Powerbuttonp...

Page 53: ... Liteproductsindicatethatnocodingis required Nocodingonlyapplieswhenthese stripsareusedwithcertainAbbottmeters and doesnotapplytotheOmnipod System Note Ifyouneedtoadjustthecodenumberafter thePDMhasmovedtothenextscreen pressthe Up Downbutton Thecodescreenreappearsand youcanadjustthenumber Note Itisimportanttoalwaysenteracode whetherusingFreeStyleorFreeStyleLitewiththe Omnipod System evenifsomeFreeS...

Page 54: ...andthetestsite forexample yourupperarm withsoapandwater Donotleaveanycreamorlotiononthe testsite Thoroughlydryyourhandsandthetestsite Measurementsobtainedfromalternatesitetestingshouldnotbeusedto calculateinsulindoseswiththeOmnipod System Totestyourbloodglucoseortoperformacontrolsolutiontest 1 Prepareadropofbloodorcontrolsolution Blood a Lancethetestsite followingyourlancingdeviceinstructions b Ge...

Page 55: ...uwillhearthePDMbeep onceifBGsoundissettoon IfthePDMdoesnotdisplay Checking afterfive seconds thesamplemaybetoosmall Youcanadd morebloodtothesameedgeofthestripupto60 secondsafterthefirstapplication 7 ContinuetowatchthePDMscreen Whenthe bloodglucosereadingiscomplete theresultisdisplayedonthescreen Also ifBGsoundison thePDMbeepstwice Note Thehigheryourbloodglucoselevel the longerthetesttakes Note Ift...

Page 56: ...solutiontest goto Bloodglucoseresults onpage42 Control solution results Ifthisisacontrolsolutiontest youmustverifytheresultsandtagitasacontrol solution Caution Ifyoufailtotagacontrolsolutionproperly itsvalueisaveragedinto yourbloodglucosehistoryrecords 1 ComparethenumberdisplayedonthePDMscreen totherangeprintedonthecontrolsolutionvial 2 Ifthenumberdisplayedisoutsidetherangeonthe vial followthecont...

Page 57: ...twanttodeliverabolus pressDone 3 Ifyouwanttodeliverabolusand a TheBolusCalculatorison pressNextandgotostep4onpage48 Note IfyourbloodglucosereadingisbelowyourMinimumBGforCalcs orreadsHIGH theBolusCalculator evenifturnedon istemporarily disabled Followyourhealthcareprovider streatmentsuggestions b TheBolusCalculatorisoff pressBolusandgotostep4onpage50 Note Ifyourbloodglucosereadingisbelow3 9mmol Lor...

Page 58: ...d glucose thenretestusinganewteststrip Ifyoustillgeta TreatyourlowBG reading performacontrolsolutiontesttoensureyoursystemisworking properly Ifthesystemisworkingproperly followyourhealthcareprovider s recommendationtotreathypoglycemia Highreadings Ifyourreadingisatorabove13 9mmol L thePDMdisplays Checkfor ketones Thisindicatesseverehyperglycemia highbloodglucose If HIGH alsoappearsonthePDM thisind...

Page 59: ...nindicatea potentiallyseriousconditionrequiringimmediatemedicalattention Ifleft untreated thesesituationscanquicklyleadtodiabeticketoacidosis DKA shock coma ordeath Consultyourhealthcareproviderforhowtotreathigh andlowbloodglucoselevels Using BG Meter YoucanmeasureyourbloodglucoseusingaseparateBGmeterandthenusethe PDMtodeliverabolus YoucanalsosavethisbloodglucosereadinginthePDM s BGhistoryrecords ...

Page 60: ...oumaytagtheresultasapre orpost mealtest orto indicatealevelofexercise Youcanaddorchangetagsonyourbloodglucose resultsuptotwohoursafteryouenterthebloodglucosevalue Toaccessthetags 1 Ifnecessary bringupthetagscreenbynavigatingto Home Moreactions Assign EditBGtags 2 UsetheUp Downbuttontochoosethefirstitem you dliketotag andpressTag 3 UsetheUp Downbuttontoscrollalongthelistof potentialstags Highlighta...

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Page 62: ...ngabolus ForanexplanationofbolusesandtheBolusCalculator seepage144 Bolusing with the Bolus Calculator Tochangeyourpersonalsettings ortoturntheBolusCalculatoronoroff see BolusCalculatorSettings onpage70 Enter your BG and meal information TodeliverabolususingtheBolusCalculator 1 Measureyourbloodglucose IfusingaseparateBGmeter followthe instructionsincludedwithyourBGmeter Ifyouusedthebuilt inBGmeter ...

Page 63: ...ownbuttontoenterthegrams ofcarbsinyourmeal thenpressEnter Or ifyouhavedefinedoneormorecarb presets either 1 selectacarbpreset or 2 select entermanually usetheUp Down buttontoenterthegramsofcarbsinyour meal andpressEnter Tocreateacarbpreset see Carbpresets on page73 Deliver the bolus TheBolusCalculatorcalculatesasuggestedbolusand displaystheresult Itiscalledasuggestedbolusbecause youmusteitherconfi...

Page 64: ...ndedbolus settingdetermineswhetherthescreendisplays percent orunits U Note Youcanonlyextendthemealportionofthebolus andtheextended bolusoptionmustbeturnedon Toviewthecorrectionbolusandmealbolus portionsofthesuggestedbolus presstheInfobutton 4 IftheBGreminderoptionisturnedonandyouwantaremindertocheck yourbloodglucose pressYes UsetheUp Downbuttontoenterthetimefor thereminder PressOK See BGreminders ...

Page 65: ...en Home Bolus 4 Enteryourcalculatedbolusamount UsetheUp Downbuttontoenterthebolusamount thenpressEnter Or ifyouhavedefinedoneormoreboluspresets either 1 selectabolus preset or 2 select entermanually usetheUp Downbuttontoenter thedesiredbolusamount andpressEnter Tocreateaboluspreset see Boluspresets onpage76 Note YoucanonlygiveabolusatorbelowtheMaximumBolusyouhave set See MaximumBolus onpage75forin...

Page 66: ...bolus Tip Onceabolusisstarted thePodfinishesdeliveringtheboluswhetherornotitis inrangeofthePDM Duringtheextendedportionofabolus checktheStatusscreentoseehowmuch oftheextendedbolusremainstobedelivered YoucanuseyourPDMforother tasksduringtheextendedportionofabolus ToaddaninformationaltagtotheBGvalueusedforthisbolus see Taggingthe BloodGlucoseResults onpage45 Altering an Ongoing Bolus Youcancancelani...

Page 67: ...fbolusdeliveryhasnot finishedyet pressCancel onthe Deliveringbolus screen ThePodbeepsto confirmthatthebolusis canceled 3 PressOK Cancel an extended bolus Tocancelanextendedbolus 1 Ifnecessary turnonyourdeviceandconfirmyourID 2 ChooseHome Suspend cancel 3 ChooseCancelextendedbolus thenpressSelect 4 PressConfirmtocancelthebolus ThePodbeepswhenthebolusiscanceled ...

Page 68: ...nteringthenew bolusamount press Extend Ascreenappears tellingyouthatan extendedbolusisactive 3 PressYestocancelthe extendedbolus 4 PressConfirm 5 Thenextscreendisplays theundeliveredamountof theoldextendedbolus Writethisnumberdownif youwanttoaddittothenewextendedbolus 6 PressNext 7 Toaddtheundeliveredamountoftheoldbolus use theUp Downbuttontoincreasethebolusamount 8 PressExtendandfollowtheon scree...

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Page 70: ...ctivateatempbasal Toenable tempbasals see Tempbasalconfiguration onpage68 Tip Ifyoufindyourselfrepeatedlyusingthesametempbasalsettings createatemp basalpresetforspeedyactivation see Tempbasalpresets onpage68 Activate a temp basal Tempbasalscanlastupto12hours Whentheyend thePDMautomatically revertstodeliveringthescheduledBasalProgram Ifyouhavealreadydefinedoneormoretempbasalpresetsandwouldliketo ac...

Page 71: ...te DecreasingatempbasaltoOFFturnsoffinsulindeliveryforthe specifiedtimeperiod Formoreinformation see Tempbasallimitations onpage141 Foracomparisonofmethodstostopinsulindelivery see Methodstotemporarilystopinsulindelivery onpage142 7 Whenthescreenshowsthedesiredtempbasalrate pressEnter 8 UsetheUp Downbuttontospecifyhowlongyouwantthetempbasaltolast 9 PressEnter 10 Afterreviewingthespecifiedtempbasal...

Page 72: ...ets onpage68 1 NavigatetotheTempbasalscreen Home Tempbasal 2 Thelistofexistingtempbasalpresetsappears Use theUp Downarrowtohighlightthedesiredtemp basalpreset Ifyoudonotwanttouseoneofthetempbasal presets select entermanually andgotostep4on page55 3 PressSelect 4 Ifyouwanttochangethedurationofthetempbasal usetheUp Downbuttontochangetheduration 5 Afterreviewingthespecifiedtempbasalrateandduration pr...

Page 73: ...dofa tempbasal see Confidencereminders onpage80 Youcanalso optionally havethePodbeepevery60minuteswhileatempbasalisrunning see Program reminders onpage80 Switching to a Different Basal Program Somedayshavedifferentroutinesthanothers andsothePDMletsyoucreate differentBasalProgramstomatchthedifferentroutines Forexample youmay useoneBasalProgramonweekdaysandadifferentoneonweekends Toswitchtoadifferen...

Page 74: ...temletsyoususpendallinsulindeliveryforupto twohours Tohelpunderstandthedifferencebetweenstoppinginsulindeliveryusingthe suspendfeatureorthetempbasalfeature see Methodstotemporarilystop insulindelivery onpage142 Suspendinsulindelivery 1 FromtheHomescreen pressSuspend 2 UsetheUp Downbuttontospecifytheduration ofthesuspension Thesuspensioncanlastfrom 30minutesupto2hoursandcanbeadjustedin 30 minuteinc...

Page 75: ... PressOKtoresumeinsulindelivery 3 ThePDMactivatestheBasalProgramthatis scheduledforthecurrenttimeandbeepstoalert youthatinsulindeliveryhasresumed Ifyoudonotresumeinsulindeliveryimmediatelywhen thesuspensionperiodends thePDMandPodbeep every15minutesuntilinsulindeliveryisresumed Warning Insulindeliverydoesnotautomaticallyresumeattheendofthe suspensionperiod YoumustpressOKtoresumeinsulindelivery Ifyo...

Page 76: ...Youmayneedtoresetthedateandtimetoadjustfordaylight savingstimeor changingtimezones 1 IfyouhaveanactivePod youmustsuspenditfirst Home Suspend 2 Navigateto Home Settings Systemsetup Date time 3 Choosethetime andpressEdit UsetheUp Downbuttontoenterthenew time TochangebetweenAM PManda24 hourclock press12 24hr Press Enter thenpressConfirm 4 Choosethedate andpressEdit Changetheyear month dayasdesired pr...

Page 77: ...DM suchasphonenumbers addresses orprescriptioninformation Toviewthesenotes presstheInfobutton fromtheHomescreen 1 Home Myrecords Myinfo 2 Highlight Myinfo andpressEdit Entertheinformationyouwouldliketo store see DataEntry onpage6 thenpressSave Vibrate and sound options ThePDMtreatsalarmsandnotificationsdifferently Forsafetyreasons alarms arealwaysaudibleandcannotbesettovibrate however youcancontro...

Page 78: ...ttons YoucanlockthePDMtopreventaccidentallychangingBasalProgramsorgiving boluses WhenthePDMislocked youcanstillusethebuilt inBGmeter check yourhistoryrecords andunlockthePDM 1 Home Settings Systemsetup PDMoptions PDMlock 2 ChooseOntolockthePDMorOfftounlockit ThenpressSelect Screen time out Topreservebatterypower thePDMscreenturnsoffifyouhavenotpresseda buttonforthespecifiedtimeinterval Tochangethe...

Page 79: ...appropriateforyou Tip ThepagesattheendofthisUserGuidecanbeusedtorecordyoursettings 2 IfyouhaveanactivePod deactivateit Home Moreactions Changepod 3 Goto Home Settings Systemsetup Diagnostics ResetPDM 4 PressConfirmtodeleteyourcurrentusersettingsandreturnallusersettings tothefactorydefaultvalues Note HistoryrecordsandIOBdataarenotdeleted 5 FollowthePDMsetupdirectionsstartingat Usernameandscreencolo...

Page 80: ...isplaysyourexistingBasalPrograms Adiamond icon appearsnexttotheactiveBasalProgram CreateanewBasalProgram Tip IfyournewBasalProgramissimilartoanexisting BasalProgram youcansavetimebyusingthe copy featureandmodifyingthecopiedprogram see Makea newBasalProgramfromanexistingBasalProgram on page67 TocreateanewBasalProgram 1 Home Settings Basalprograms addnew Note The addnew optionisnotavailableifyou alr...

Page 81: ...Anon editablescreenappearsdisplayingthebasal segmentsfortheselectedBasalProgram PressList orGraphtoseetheProgramastextoragraph ModifyaBasalProgram TomodifyaBasalProgram 1 Home Settings Basalprograms 2 HighlighttheBasalProgramyouwouldliketoedit andpressSelect Note ToedittheactiveBasalProgram youmusteithersuspendinsulin delivery Home Suspend oredititwhenyouhavenoactivePodduringa Podchange 3 Highligh...

Page 82: ...s Basalprograms 2 HighlighttheBasalProgramyouwouldliketocopy andpressSelect 3 HighlightCopyandpressSelect Note IfyoualreadyhavesevenBasalPrograms youmustfirstdeletean existingBasalProgrambeforeyoucancreateacopy see DeleteaBasal Program onpage67 4 EnterauniquenameforthenewBasalProgram see Enteringtext onpage 6 andpressNext AscreenappearsshowingtherenamedBasalProgram withtheoriginalbasalsegments 5 T...

Page 83: ...Toactivateatempbasalpreset see Activateatemp basalpreset onpage57 Createanewtempbasalpreset 1 Home Settings Presets Tempbasalpresets 2 UsetheUp Downbuttontoscrolldownto addnew atthebottomofthe list PressNew Note Youcanonlyhaveseventempbasalpresets Ifyoualreadyhaveseven addnew doesnotappear Ifnecessary youcandeleteanexistingone 3 Enteranameforthenewtempbasalpreset see Enteringtext onpage6 PressNext...

Page 84: ... Enteringtext on page6 PressSave 4 Toeditthetempbasalpreset a SelectEdit b Changethetemporarybasalrate ifdesired PressNext c Changethedurationofthetempbasal ifdesired PressSave 5 PressDonetoreturntothetempbasalpresetscreen Deleteatempbasalpreset Note Youcannotdeleteatempbasalpresetthatisactivelyrunning 1 Home Settings Presets Tempbasalpresets 2 Highlightthetempbasalpresetyouwouldliketodelete scrol...

Page 85: ...ettings Systemsetup Bolus basal calcs Boluscalcs 2 ToturntheBolusCalculatoroff selectOffandpressDone 3 ToturntheBolusCalculatoron selectOnandpressNext Thefollowing screensguideyouthroughthepersonalizedBolusCalculatorsettings For detailedinstructions seethefollowingpagesorgoto TargetBGandCorrect Abovevalues onpage17 Note IfyouhavenotpreviouslysetuptheBolusCalculatorreferto Bolus Calculatorsettings ...

Page 86: ...ndisafixedvalue throughouttheday 1 Home Settings Systemsetup Bolus basal calcs Ratios factors targets MinBGforcalcs 2 UsetheUp Downbuttontospecifytheminimumbloodglucoseforuseby theBolusCalculator thenpressNext IC Ratio TheICRatio Insulintocarbohydrateratio defineshowmanygramsof carbohydratesarehandledbyoneunitofinsulin TheBolusCalculatorusesyour ICRatiotocalculateamealboluswhenyouaregoingtoeat You...

Page 87: ...settingdetermineshowtheBolusCalculatorhandlesmeal boluseswhenyourbloodglucosevalueisbelowyourTargetBG see Reverse Correction onpage146formoredetails 1 Home Settings Systemsetup Bolus basal calcs Ratios factors targets Reversecorrection 2 ChooseOnorOff andpressNext Duration of insulin action TheBolusCalculatorusesyourdurationofinsulinactionsettingtocalculatethe amountofinsulinonboard IOB fromaprevi...

Page 88: ...efood thenpressNext 6 Thenextstepisto optionally specifythegramsoffiberinthemeal Consult withyourhealthcareprovideraboutwhetherornottoenterthefiber information Note Ifyouenterthegramsoffiberintoyourcarbpreset theBolus Calculatorsubtractsthegramsoffiberfromthegramsofcarbohydrates Alternately instep5above youcanenterthetotalgramsofcarbsminusthe fiberyourself 7 PressNext 8 Ifyouwant youcanenterthegra...

Page 89: ...erornottoenterthefiber information Note Ifyouenterthegramsoffiberintoyourcarbpreset theBolus Calculatorsubtractsthegramsoffiberfromthegramsofcarbohydrates Alternately instep6above youcanenterthetotalgramsofcarbsminusthe fiberyourself 8 PressNext 9 Ifyouwant youcanenterthegramsoffatandproteinandthetotalcalories inthemeal PressNextaftereachentry Enteringtheseadditionalnumbersis optional 10 PressDone...

Page 90: ...um Bolus TheMaximumBolusdefinestheupperlimitforamanually calculatedbolus The BolusCalculatorwarnsyouifitcalculatesabolusthatisoverthisamount The largestallowedvalueoftheMaximumBolusis30units Caution TheMaximumBolusdefaultis10units Checkwithyourhealthcare providerbeforeadjustingthissetting 1 Home Settings Systemsetup Bolus basal calcs Maxbolus 2 UsetheUp DownbuttontospecifytheMaximumBolus thenpress...

Page 91: ...ew 3 Enteranameforthenewboluspreset see Enteringtext onpage6 and pressNext 4 UsetheUp Downbuttontoentertheamountofthebolus andpressNext 5 PressSave Editorrenameaboluspreset 1 Home Settings Presets Boluspresets 2 Highlighttheboluspresetthatyouwanttoedit thenpressEdit 3 Torenamethepreset highlightRename andpressSelect Thenenteranew name see Enteringtext onpage6 andpressNext 4 Tochangethevalueofthepr...

Page 92: ...setup Alerts reminders BGreminder 2 ChooseOntoincludetheBGreminderqueryinthebolusflow ChooseOff toskiptheBGreminder 3 PressSelect Pod expiration ThePodexpirationnotificationtellsyouwhenthePodisnearingitsexpiration soyoucanplanforaPodchangeataconvenienttime Thisnotificationcan rangefrom1to24hoursbeforethePodexpirationadvisoryalarmsounds Atthe selectedtime thePodandPDMbeepandthePDMgeneratesamessage ...

Page 93: ...p Downbuttontospecifythelengthoftimefor thecountdowntimer Thissettingcanrangefrom1to24hours Example Ifyouchoosethreehours youmustactivateyourPDMonceevery threehours dayandnight topreventtheAuto offalarm 4 PressEnter Warning YoumustusethePDMwithin15minutesofhearingtheAuto off advisoryalarm Ifyoudonot thePDMandPodsoundahazardalarmand yourPodstopsdeliveringinsulin Bolus reminders Bolusremindersprompt...

Page 94: ...ystemsetup Alerts reminders Bolusreminders 2 HighlightOnandpressSelect 3 Highlightthetimeintervalyouwouldliketoedit andpressEdit 4 HighlightEditandpressSelect 5 UsetheUp Downbuttontoenterthestarttimefortheinterval andpress Next 6 UsetheUp Downbuttontoentertheendtimefortheinterval andpress Save 7 PressDone andthenpressSave Deleteabolusreminder 1 Home Settings Systemsetup Alerts reminders Bolusremin...

Page 95: ...startandendofabolus anextendedbolus andatempbasal Confidencenotificationsareespecially usefulwhenyouaregettingfamiliarwithyourPDMandPod Seepage101for moreinformationaboutconfidencereminders 1 Home Settings Systemsetup Alerts reminders Confidencereminders 2 Toenableconfidencereminders chooseOnandpressSelect 3 Todisableconfidencereminders chooseOffandpressSelect Exception Youcannotturnoffbeepsthatoc...

Page 96: ...minders 2 Highlightthereminderofinterest andpressEdit 3 Thenextscreendisplaysthedetailsofthatreminder a Tomakenochanges pressDone b Torename highlightRenameandpressSelect Enterthenewnameor timeforthereminder see Enteringtext onpage6 andpressNext c Tochangethetimeorfrequencyofareminder ortoturnareminderonor off highlightEditandpressSelect Enterthetimeforthereminder and pressNext Chooseafrequencyors...

Page 97: ...veyusefulinformationaboutbloodglucosereadings You cancreateupto15customtags whichappearatthebottomofthetagslist and hideanyofthestandardtagsyoudonotplantouse 1 Home Settings Systemsetup BGmeter 2 HighlightManageBGtaglist andpressSelect 3 ToshoworhideastandardtagontheStandardBG tagslist highlightthetagofinterestandpressShow orHide Youmayneedtoscrolldowntofindthetag orinterest PressDonewhenfinished ...

Page 98: ...meter sound Youcancontrolwhetherthebuilt inBGmeterbeepswhentheteststripisfullof bloodorcontrolsolution 1 Home Settings Systemsetup BGmeter 2 HighlightBGsound andpressSelect 3 ChooseOntoenablethebeepsorOfftodisablethebeeps ThenpressSelect ...

Page 99: ...84 Thispageintentionallyleftblank ...

Page 100: ...otatriskifthePDMbatteryrunsout Thedateand timemayneedtobereset butthehistoryrecordsareunaffected Overview of the Records Screens Thissectiondescribeshowtonavigateyourrecordsandunderstandthemeanings ofthesymbolsusedonthehistoryscreens The Records menu ToaccesstheRecordsmenu navigateto Home Myrecords TheRecordsmenuallowsyoutoselectacategoryof historyrecordstoview insulindelivery BGreadings alarms or...

Page 101: ...onasexplainedinthefollowingsections SelectingEvent SelectingtheEventoptionswitchesthehighlighting fromthedateintothelistofitems Whenthehighlightingisinthelistofitems pressingtheUp Downbuttonallows youto Scrollupordowntoviewlistitemsthatare off screen Scrolltoalistitemthathasa moreinfo iconnexttoit Oncethelistitemishighlighted youcanseeadditionaldetailsaboutthatitemby pressingtheInfobutton ...

Page 102: ...ram activetempbasal orongoingextendedbolus e Extendedbolus Insulindeliveryspannedmidnight Therecordislistedonbothdays Insulindeliveryrecordis unconfirmed Inthissituation thechange inthebasalorbolusinsulindeliverywasbegunbutthePDMhasnot receivedastatusupdatefromthePodconfirmingthecurrentstatus IfthePDMreceivesastatusupdateconfirmingdelivery thePDM removesthecheckmarksymbolfromtherecord Insulindeliv...

Page 103: ...annot calculatehowmuchinsulinwasactuallydeliveredonthatday See Meaningof iconsusedonrecordscreens onpage87 Bolus history Thebolushistoryscreendisplaysaday by daylistofthetimeandunitsofinsulin deliveredforeachbolus Ifaportionofaboluswasextended theimmediate portionandtheextendedportion markedwithan e aredisplayedontwo separatelines Anextendedbolusentryliststhedurationaswellastheunitsand starttime I...

Page 104: ...asalisindicatedbyadiamond icon 1 Toseetherecordsofyourbasalinsulindeliveryfora singleday navigateto Home Myrecords Insulindelivery Basal 2 UsetheUp Downbuttontoviewbasalratedata fromdifferentdatesortoscrollthroughtheitems listedonthescreen see Selectinglistitemsordates onpage86 3 Toseeadditionaldetailsaboutalistitemthathasa iconnexttoit usetheUp DownbuttoninEvent modetohighlightthelistitem Thenpre...

Page 105: ...ome Myrecords BGhistory Thesummaryscreendisplays Totalnumberofreadings listedas n x Theaveragebloodglucosereadingfortheday Theday smaximumandminimumblood glucosereading YourBGGoalRange andthepercentofBG readingsthatwerewithintherange abovethe range andbelowtherange 2 UsetheUp Downbuttontochangethedate displayed see Selectinglistitemsordates onpage86 3 ToseealistofeachBGreadingfortheselectedday pre...

Page 106: ...seven daysummaryofyourbloodglucoserecords 1 PressTrendsfromthesingle daylistorgraph or fromtheStatusscreen navigateto Home Myrecords BGhistory Trends Thesummaryscreenformultipledaysisquitesimilartothesummaryscreen foroneday seetheSummaryscreenonthepreviouspage Thesummary screendisplays Thenumberofdaysincludedinthesummary TotalnumberofBGreadingsforthemulti dayperiod listedas n x TheaveragenumberofB...

Page 107: ... Home Myrecords Alarmhistory 2 UsetheUp Downbuttontoscrolldownthelist 3 Toseeadditionaldetailsaboutalistitemthathas a iconnexttoit pressEventandusetheUp Downbuttontohighlightthelistitem andthen presstheInfobutton PressClosewhendone Carbohydrate History Records Thecarbohydraterecordsstorethedate time andgrams ofcarbohydratesyouhaveentered 1 Toseeadailyrecordofyourcarbohydrateentries navigateto Home...

Page 108: ...throughtheitemson thelist see Selectinglistitemsordates onpage86 3 Toseeadditionaldetailsaboutalistitemthathasa iconnexttoit usetheUp DownbuttoninEvent modetohighlightthelistitem andthenpressthe Infobutton PressClosewhendone My Info ToviewanybriefnotesthatyouhaveenteredusingtheMyinfofeature see Storingbriefnotes onpage62 1 Navigateto Home Myrecords Myinfo 2 PressBackortheHomebuttonwhendone Note Yo...

Page 109: ...94 Thispageintentionallyleftblank ...

Page 110: ...tionyoumaywanttoperform Informationalbeepsareinformationalonly noactionisneeded CommunicationfailuresoccurwhenthePDMisunabletocommunicate withthePod BGmetererrorsoccurwhenthebuilt inBGmetercannotperforman accuratetest Tomakeyouawareofanalarm notification orothermessage thePodsoundsa toneandthePDMcansoundatoneorvibrate ThePDMcanalsodisplayanon screenmessage Thischapterexplainsthesesoundsandmessages...

Page 111: ... reservoir Insulin delivery stopped Change Pod now ThePod sinsulin reservoirisempty PodandPDMsound alarm PressOK ChangePod Checkbloodglucose Auto off Remove Pod now Insulindeliveryhas stopped Thisalarm canbeturnedonoroff PodandPDMsound alarm PressOK ChangePod Checkbloodglucose Occlusion detected Insulin delivery stopped Change Pod now ThePod scannulais blockedsoinsulin cannotpassthrough PodandPDMs...

Page 112: ...rroroccursafterthe PDMisreset PDMsoundsalarm PressOK ChangePod Checkbloodglucose PDM Error Press OK to reset clock Timeanddateneedto beresetafteraPDM error PDMsoundsalarm PressOK Resetclock ChangePod Checkbloodglucose Poddeactivationrequired Press OK to deactivate IfaPodisactiveduring aPDMerrorrequiring aclockreset youmust replacethePod PDMsoundsalarm PressOK ChangePod Checkbloodglucose Ifatempbas...

Page 113: ...w 2setsof4beeps repeating periodically Repeatsevery15 minutesduring thelasthourofthe Pod slife PodandPDM beep Podexpiration advisoryalarm Your Podwillexpiresoon EscalatestoPod expiredhazardalarm ifignored PressOK ChangePod Low reservoir Replace Pod soon x U 2setsof4beeps everyminute for3minutes Repeatsevery 60minutesuntil acknowledged PodandPDM beep Lowreservoir advisoryalarm The volumeofinsulinin...

Page 114: ... repeatevery5 min PDMbeeps ThespecifiedPDM buttonisstuck Pressthebutton tounstickit Ifthisdoes notwork call CustomerCare USB device ready PDM functionality is disabled while USB is connected 2setsof4beeps repeatsevery5 min PDMbeeps AUSBcableis pluggedintoyour PDM Unplugthe PDMcableto restorePDM functionality Toturnonoroff see PodAuto off onpage78 Notifications Notificationsremindyouaboutvarious ac...

Page 115: ...every5min PDMbeeps Remindsyoutocheck yourbloodglucose afterabolus PressOK Checkblood glucose Reminder Missed bolus Meal bolus not delivered during reminder period start time end time 2setsof3 beeps repeat every15min PDMbeeps Youhavenotdelivered aboluswithinthe timeperiodyouhave specified PressOKto acknowledgethe bolusreminder Low PDM batteries Change batteries soon Nobeeps ThePDMbatteriesare low R...

Page 116: ...beep repeatsevery 60min Toturnthese beepsonoroff see Programreminders onpage80 Extendedbolus ongoing Singlebeep repeatsevery 60min Tempbasalcancellation Singlebeep Cannotturnthese beepsoff Boluscancellation Singlebeep Extendedbolus cancellation Singlebeep Poddeactivated Twobeeps Cannotturnthese beepsoff Podactivationinprogress 2setsof4 beeps repeat every5min Podactivated Twobeeps Podprimecomplete ...

Page 117: ... thePDM attemptstoreestablishcommunication Thefollowingsectionsdescribesituationsthatcanresultincommunication failuresandwhatactionyoushouldtake Failure to receive a Pod status PDMmessage Whattodo IfthePDMdoesnotgetastatusupdatefromthe PodshortlyafteryouturnonthePDMorpress Status thePDMcontinuestosendtherequest Youhavetwochoices WaitwhilethePDMattempts tocommunicateorpressSkip Pod status not avail...

Page 118: ...omthePod Communication timeout Press Ok to check pod status or press Discard to deactivate pod PressOKtoresendthePodstatusrequest orpress Discardtobeginthedeactivationprocess IfyoupressDiscard goto Failurewhen deactivatingaPod onpage105 Ifthecommunicationisreestablishedbeforetimeout Communication successful YourlastcommandwassuccessfullysenttothePod PressOK Ifthecommunicationisreestablishedafterti...

Page 119: ...vateanewPod Communication timeout Bolus status unknown Press Ok to check pod status or press Discard to deactivate pod IfyoupressedRetryonthepreviousscreenand thePDMstillcannotcommunicatewiththePod thePDMdisplaysthemessageshownhere PressOKtocheckthePodstatus If communicationisreestablished seepage103 PressDiscardtodeactivatethePodandgoto FailurewhendeactivatingaPod onpage105 Ifatanypointinthisproc...

Page 120: ...ouactivateanewPodtoprevent hypoglycemia Specialsituation Aspecialsituationexistsifaboluswasbeingdeliveredwhencommunicationwas lost becausethePDMdoesnotknowhowmuchoftheboluswasdelivered This causestheBolusCalculatortobetemporarilydisabledbecauseitcannotcalculate avalidIOB insulinonboard TheBolusCalculatorisre enabledwhenno insulinremainsinyourbodyfromtheoldbolus Thislengthoftimeisdetermined byyourd...

Page 121: ...ontrolsolutiontestusing anewteststrip Iftheresultsofthe controlsolutiontestarewithinthe rangeprintedonthesideofthetest stripvial retestusingbloodandanew teststrip Ifthecontrolsolutiontestdoes notwork ortheerrorpersists call CustomerCare Meter Error 2 See user manual for further instructions 4possibilities Problemwith theteststrip Problemwith themeter Veryhighblood glucose above 27 8mmol L HIGHcont...

Page 122: ...testusingbloodandanew teststrip Ifthecontrolsolutiontestdoes notworkortheerrorpersists call CustomerCare Meter Error 4 See user manual for further instructions 2possibilities Problemwith theteststrip Problemwith themeter Conductacontrolsolutiontestusing anewteststrip Iftheresultsofthe controlsolutiontestarewithinthe rangeprintedonthesideofthetest stripvial retestusingbloodandanew teststrip Iftheco...

Page 123: ...Note Pressdownfirmly Thepaper clipmaygoinalittlebitandthenstop Youmustcontinuepressingdown very hard untilthealarmstops Youneedtoapplyenoughforcetobreakathin layerofplastic PDMalarm IfyoucannotturnoffaPDMalarmusingthePDM ssoftkeys you cansilencethePDMalarmasfollows 1 TurnthePDMoverandremovethedoor ofthebatterycompartment 2 Leavingthebatteriesinplace locatethe smallalarmresethole surroundedby green...

Page 124: ...lCustomerCare Pod and insulin storage ExtremeheatorcoldcandamagePodsandcausethemtomalfunction IfPodsare exposedtoextremetemperatures inspectthemcarefullybeforeuse Itisespeciallyimportanttostoreyourinsulininawell controlledenvironment Inspectinsulinbeforeusingit neveruseinsulinthatlookscloudyordiscolored Insulinthatiscloudyordiscoloredmaybeold contaminatedorinactive Check theinsulinmanufacturer sin...

Page 125: ...rs 25feet orforlongerthan60minutes Checktheinfusionsiteoften tomakesurethePodandsoftcannulaaresecurelyappliedandinplace Ifthe cannulaisnotproperlyinserted hyperglycemiamayresult Verifythereisno wetnessorscentofinsulin whichmayindicatethecannulahasdislodged CleaningyourPod Podsarewaterproof IfyouneedtocleanaPod gentlywashitwithaclean damp cloth oryoucanusemildsoapandwater However donotusestrongdete...

Page 126: ...Useaclean lint freeclothtogentlyabsorbanywaterinthebattery compartment Caution NeveruseablowdryerorhotairtodrythePodorPDM Extreme heatcandamagetheelectronics 4 LeavethebatterycompartmentdooropenuntilthePDMisthoroughlydry 5 DonotputinfreshbatteriesorattempttousethePDMuntilithas thoroughlyair dried 6 CallCustomerCareifthePDMdoesnotworkaftertheabovesteps Caution ThePDMisnotwaterproof DoNOTplaceitinor...

Page 127: ...ocery hardwareorconveniencestores Caution AAAalkalinebatteriesareusedtopowerthe PDM Donotuseanyothertypeofbatteries Neveruse oldorusedbatteries thePDMmaynotworkproperly Usinganykindofbatteriesotherthanalkalinemay reducebatterylifeandcausedamagetothePDM Do notuserechargeablebatteries Undernormaluse apairofbatteriespowersthePDM foratleastthreeweeks Thebatterylifeindicatoronthe PDMshowsthebatterypowe...

Page 128: ...seoftheoldbatteriesinaccordancewithlocal wastedisposalregulations PDM cleaning and disinfecting Thebasics CleaningismeanttokeepyourPDMfreefromdirt stains orimpurities unsoiled Disinfectingistheprocessofdestroyingpathogenicorganismsor renderingtheminert Thevalidatedguidelinesbelowareforcleaningand disinfectionofthePDM AlwayskeepyourPDMteststripportandUSBportfreeofdebrisandliquids Dirt dust blood an...

Page 129: ...loroxProfessionalProductsCo healthcare clorox com 1 800 234 7700 3 Allowthesurfacetoremainwetforoneminutepriortouse Caution Whilecleaning doNOTallowdebrisorliquidtogetintotheteststrip port USBport speakerorpowerbutton DisinfectingthePDM YoushoulddisinfectyourPDMonceaweekasfollows 1 Performacleaningasoutlinedintheprevioussection 2 DisinfectthePDMsurfacebywipingitwithafreshDispatch Hospital CleanerD...

Page 130: ...t References Formoreinformation see FDAPublicHealthNotification UseofFingerstickDevicesonMorethan OnePersonPosesRiskforTransmittingBloodbornePathogens Initial Communication 2010 http www fda gov MedicalDevices Safety AlertsandNotices ucm234889 htm CDCClinicalReminder UseofFingerstickDevicesonMorethanOnePerson PosesRiskforTransmittingBloodbornePathogens 2010 http www cdc gov injectionsafety Fingers...

Page 131: ...DM sbuilt inBGMeter useabackupBGMeterto checkyourbloodglucose Warning IfyourPDMisdamagedornotworkingasitshould pleasecall CustomerCareforassistance Besuretocheckyourbloodglucosefrequently RemoveyourPodandcontactyourhealthcareproviderfortreatment guidelinestofollow ...

Page 132: ...tivities ToensureproperOmnipod Systemoperationandyourcontinuedgoodhealth checkyourPodsite yourPDMmessages andyourbloodglucosefrequently Infusion site checks Atleastonceaday usethePod sviewingwindowtoinspecttheinfusionsite Checkthesitefor Leakageorscentofinsulin whichmayindicatethecannulahasdislodged Signsofinfection suchaspain swelling redness dischargeorheat Warnings Ifyoususpectaninfection immed...

Page 133: ...ohelpyoudevelopplansforhandlingemergency situations includingwhattodoifyoucannotreachyourhealthcareprovider Warning Keepanemergencykitwithyouatalltimestoquicklyrespondto anydiabetesemergency Prepareanemergencykittokeepwithyouatalltime Thekitshouldinclude Severalnew sealedPods ExtranewPDMbatteries atleasttwoAAAalkaline donotuserechargeable batteries Avialofrapid actingU 100insulin seetheIntroductio...

Page 134: ... however figuringoutthecorrectBasalProgramcanbemorechallenging Yourhealthcare providercanhelpwiththeseadjustments Take enough supplies Keepyouremergencykitwithyouduringtripsorvacations see Preparefor Emergencies onpage118 Itmaybedifficultorimpossibletogetinsulinor suppliesinanunfamiliarplace Iftravelingbyair besuretopackyoursupplies inyourcarry onluggage Whenpackingfortravel takemoresuppliesthan y...

Page 135: ...ththeiroriginal prescriptionlabels Theairportmayoffertheoptionofrequestingavisualinspectionofyourmedical suppliesratherthanputtingthemthroughtheX ray Youmustrequestthisbefore thescreeningprocessbegins Yourmedicalsuppliesshouldbeinaseparatebag whenyouapproachthesecurityofficer Topreventcontaminationordamagetoyoursupplies youshouldbeaskedatthe securitycheckpointtodisplay handle andrepackyourownsuppl...

Page 136: ...d Systembypracticing propertechniquesandbyactingpromptlyatthefirstsignofhypoglycemia hyperglycemia ordiabeticketoacidosis Theeasiestandmostreliablewaytoavoid theseconditionsistocheckyourbloodglucoseoften General precautions Keepcarefulrecordsanddiscusschangesandadjustmentswithyour healthcareprovider Tellyourhealthcareproviderifyouhaveextremehighsorlows orifhighsor lowsareoccurringmoreoftenthanusua...

Page 137: ...eminders onpage 77 Makesureyourbloodglucoseisatleast5 6mmol Lbeforedrivingor workingwithdangerousmachineryorequipment Hypoglycemiamaycause youtolosecontrolofacarordangerousequipment Also whenyoufocus intentlyonatask youmaymissthesymptomsofhypoglycemia Evenifyoucannotcheckyourbloodglucose doNOTwaittotreatsymptoms ofhypoglycemia especiallyifyouarealone Waitingtotreatsymptomscould leadtoseverehypogly...

Page 138: ...renessor asevereadversereaction Keepaglucagoninjectionkitwithyouremergencysupplies Teachfriends andfamilymembershowtogiveaglucagoninjectionincaseyouhavesevere hypoglycemiaandbecomeunconscious Periodicallychecktheexpirationdateofyourglucagonkittomakesureithas notexpired Note Alwayscarrymedicalidentification suchasanemergencywalletcard and wearanemergencymedicalnecklaceorbraceletsuchastheMedicAlertt...

Page 139: ...yourhealthcareprovideraboutadjusting yourBasalProgramsorusingatempbasal Incorrectbolus timing or Bolustoolarge Takeboluswithfood Checkbloodglucosebeforegivingamealbolus If necessary adjustthebolus Checkthebolussizeandtiming Donotovercorrectforpost mealglucoselevels Checkcarbintake Consultyourhealthcareproviderforguidance IncorrectTargetBG level or IncorrectCorrection Factor or IncorrectICRatio Con...

Page 140: ...ndafter activityandtreatasnecessary Note Effectsofexercisecanlastseveralhours evenafullday afteractivityends Consultyourhealthcareprovideraboutadjusting yourBasalProgramsorusingatempbasal Lowcarbohydrate intakepriorto activity Checkbloodglucosebeforeactivity Consultyourhealthcareproviderforguidance Alcohol consumption Checkbloodglucosebeforegoingtobed Consultyourhealthcareproviderforguidance ...

Page 141: ...ltifappropriateactionsarenottaken Hyperglycemiasymptomscanbeconfusing Alwayscheckyourblood glucosebeforeyoutreatforhyperglycemia Symptomsofhyperglycemia highbloodglucose Neverignorethefollowingsymptoms astheycouldbeasignofhyperglycemia Fatigue Frequenturination especiallyduringthenight Unusualthirstorhunger Unexplainedweightloss Blurredvision Slowhealingofcutsorsores Toavoidhyperglycemia highblood...

Page 142: ...esyringe Askyourhealthcareproviderwhethertoinjectthe sameamountofinsulinasinstep3 6 Ifyoufeelnauseatedatanypoint checkforketonesandcallyourhealthcare providerimmediately see Diabeticketoacidosis DKA onpage129 7 Ifbloodglucoseremainshighafteranother2hours atotalof4hours replacethePod UseanewvialofinsulintofillthenewPod Then contact yourhealthcareproviderforguidance Warning Ifyouneedemergencyattenti...

Page 143: ... temp basal Incorrectbolus timing or Bolustoosmall Checkcarbintake Takeboluswithfood Checkbloodglucosebeforegivingmealbolus If necessary adjustbolus Consultyourhealthcareproviderforguidance High proteinor high fatmeal Calculateprotein fatintakeandaccountforitinyour bolustimingandbolustype Consultyourhealthcareprovideraboutusingthe extendedbolusoption Lessactivitythan normal Consultyourhealthcarepr...

Page 144: ...glucoselevels Warnings Ifleftuntreated DKAcancausebreathingdifficulties shock coma and eventuallydeath Ifyouneedemergencyattention askafriendorfamilymembertotakeyou totheemergencyroomorcallanambulance Donotdriveyourself SymptomsofDKA Nauseaandvomiting Abdominalpain Dehydration Fruity smellingbreath Dryskinortongue Drowsiness Rapidpulse Laboredbreathing ThesymptomsofDKAaremuchlikethoseoftheflu Befo...

Page 145: ...s Yourhealthcareprovidercanhelpyoumakeaplanforsickdays The followingareonlygeneralguidelines Whenyouareill checkyourbloodglucosemoreoftentoavoidDKA The symptomsofDKAaremuchlikethoseoftheflu Beforeassumingyouhavethe flu checkyourbloodglucosetoruleoutDKA see Diabeticketoacidosis DKA onpage129 Tohandlesickdays Treattheunderlyingillnesstopromotefasterrecovery Eatasnormallyasyoucan Adjustbolusdoses ifn...

Page 146: ...emovaltimestocoincidewithascheduledPodreplacement IfyouwillneedtoremovethePodformorethanonehour askyourhealthcare providertorecommendappropriateguidelines X rays MRIs and CT scans ThePodandPDMcantoleratecommonelectromagneticandelectrostaticfields includingairportsecurityandcellularphones Warning ThePodandPDMmaybeaffectedbystrongradiationor magneticfields BeforehavinganX ray MRI orCTscan oranysimil...

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Page 148: ...nonly communicatewitheachotherevenifthereareotherPodsandPDMswithin range DuringPodactivation thePDMtransferstheactiveBasalProgramdetails tothePod ThePDM scommunicationrangeisreducedduringactivation Therefore the PDMshouldtouchthePod inoroutofitstray duringPodactivation Asan addedprecaution donotactivateyourPodinthesameareathatsomeoneelseis activatingaPod HowclosedothePDMandPodneedtobeafteractivati...

Page 149: ...led this30 minute of inactivitystatuscheck isdisabled This preventsthestatuscheckfromresettingtheAuto off countdowntimer see Auto off onpage137 Resultsofstatuscheck Duringastatuscheck thePDMcollectsinformationfromthePodaboutbolus deliveries tempbasals theactiveBasalProgram reservoirvolume thetimeuntil Podexpiration andanyalarmsituations ThePDMdisplaystheresultsofthestatuscheckasfollows IfthePodiss...

Page 150: ...efore ifyouhearaPodalarm bringyourPDMinrangeofyourPodandturn onyourPDM Thistriggersastatuscheckwhichresultsinamessageexplaining thealarm Aswithalarms ifanotificationoriginatesinyourPod theremaybeadelayofup to30minutesbeforeanin rangePDMbeginstobeep WhenthePDMcannotcommunicatewiththePod WhenyouturnonyourPDM itattemptstoestablishcommunicationwiththe activePod Usually communicationoccursquickly Occas...

Page 151: ...oseoftheoldPodbefore activatinganewPod Topreventthe discarded Podfromsoundinganalarmat alatertime followtheinstructionsforsilencingthePodalarmonpage108 Ifa discarded Podsoundsanalarm thealarmwillstopafter15hours What the Pod can do between PDM instructions Onceactivated thePodcanperformthefollowingwithoutinputfromthePDM DeliverinsulinaccordingtotheactiveBasalProgram sschedule ThePodhas abuilt incl...

Page 152: ...rPDMandconfirm yourIDscreen Therefore ifAuto offisenabled makesurethePDMisinrangeof thePod thenturnonyourPDMandconfirmyourIDscreenfrequentlytoreset thetimerandpreventthealarmfromsounding Tip IfAuto offisenabled beginyourbloodglucosetestsbyturningonthePDM ratherthanbyinsertingateststripintheteststripport ActivatingyourPDMby insertingaBGteststripintotheteststripportsdoesnotresettheAuto offcountdown ...

Page 153: ...ystem stwomodes fordeliveringcontinuousbasalinsulin BasalProgramsandtempbasals Basal Programs Abasalrateisthenumberofunitsofinsulindeliveredperhour Abasalsegmentdefinesthetimeofdayduringwhichagivenbasalrateis delivered Acollectionofbasalsegmentscoveringamidnight to midnightperiodiscalled a BasalProgram Inotherwords aBasalProgramdescribestherateofinsulin deliverythroughoutanentire24 hourperiod Insu...

Page 154: ...tine youcancreateuptosevendifferentBasal Programs see BasalPrograms onpage65 ThisfigureshowstwopossibleBasal Programs oneforweekdaysandtheotherforweekends Temporary basal rates Theabilitytosettemporarybasalrates or tempbasals isanimportantfeature oftheOmnipod InsulinManagementSystem Atempbasalletsyouoverride thecurrentlyrunningBasalProgrambysettingadifferentbasalratefora predeterminedperiodoftime ...

Page 155: ...sulindeliveryfollowsthepattern definedbythecurrentlyscheduledBasalProgram butincreasesordecreasesthe insulindeliverybythespecifiedpercentage Forexample thefollowingfigure showsthata50 increaseraises theBasalProgram sinsulindeliveryby50 whilea50 decreaselowerstheBasalProgram sinsulindeliveryby50 Tempbasalfrom7AMto4 30PM BasalProgram Actualinsulindelivered Midnight Midnight Noon 0 0 2 0 4 0 6 0 8 1 ...

Page 156: ...ogram sratewiththefollowing exception YoucannotsetatempbasalthatwouldgoaboveyourMaximumBasal Rateduringanytimesegmentcoveredbythetempbasalduration Maximumtempbasal U hr Whenusingaflatrate U hr youcannotseta tempbasalaboveyourMaximumBasalRate Usingtempbasalstoturnoffbasalinsulindelivery Youcansetatempbasalto turnoffbasalinsulindeliveryforasetperiodoftime Thisoccursifyoudecrease thetempbasalamountun...

Page 157: ...lecomparesthesetwooptionsforpausinginsulindelivery Suspendinsulin Tempbasal Off Effectonbasaland bolusinsulindelivery Nobasaldelivery Nobolusdelivery Nobasaldelivery Bolusesallowed Minimumduration forstoppinginsulin 30min 30min Maximumduration forstoppinginsulin 2hrs 12hrs Insulindelivery resumesautomatically No Yes Screendisplayatend ofspecifiedduration Endofinsulinsuspend PressOKtoresumebasal ra...

Page 158: ...nyourbloodglucose Warning Whenusingtheextendedbolusfunction checkyourblood glucoselevelsmorefrequentlytoavoidhypoglycemiaorhyperglycemia Manually calculated Boluses Amanually calculatedbolusisabolusthatyouhavecalculatedyourself withoutthehelpoftheBolusCalculator Manually calculatedbolusescanbe usedwhentheBolusCalculatorissettoofforiftheBolusCalculatorisdisabled see MaximumBolus onpage144 Consultyo...

Page 159: ...boluscannotbeextended Anycorrectionbolusisalwaysdelivered first Inthefollowingexample threeunitsofinsulinareextended Totalbolus 5units 1unitcorrectionbolus 4unitsmealbolus Delivernow 2units 1unitcorrection 1unitmealbolus Extend 3units 3unitsmealbolus MaximumBolus ThePDMdoesnotallowyoutoincreaseabolusaboveyourMaximumBolus setting However ifnecessarytocoveryourmealcarbsandbloodglucosevalue theBolusC...

Page 160: ...sfirst ThereisanunconfirmedboluswhenthePDMdiscardsaPod TheBolus Calculatorremainsdisableduntilacompletedurationofinsulinaction periodpasses Youchangethetimeordateorthereisaninternalclockreset TheBolus Calculatorremainsdisableduntilacompletedurationofinsulinaction periodpasses AUSBcableisconnected TheBolusCalculatorremainsdisableduntilyou disconnecttheUSBcable TheBolusCalculatorispartiallydisabledw...

Page 161: ...etheinsulinremains onboard or active dependsonyour durationofinsulinactionsetting Note TheBolusCalculatoronlysubtractsIOBfromasuggestedbolusifyour currentbloodglucoseisknown Youshouldalwaystestyourbloodglucoseprior todeliveringabolus Durationofinsulinaction TheBolusCalculatorusesyourdurationofinsulinactionsettingtocalculatethe insulinonboardfrompriorboluses MinimumBGforCalcs TheBolusCalculatordoes...

Page 162: ...ereadingisbetween yourTargetBGandyourCorrectAbovesettings Ifyourbloodglucoseisabove 27 8mmol L thereadingisrecordedas HIGH andtheBolusCalculatorcannot calculateabolus BolusCalculatordisabledabove27 8mmol L BolusCalculatorcalculates mealandcorrectionbolus BolusCalculatorcalculatesmealbolusonly BolusCalculatorcalculatesmealbolus minusreversecorrection ifenabled BolusCalculatordisabledbelowMinBGforCa...

Page 163: ...iminarymealbolus Carbintake Insulin to carb IC ratio Example Carbintake 45gramsofcarb ICratio 15 45 carbs 3Upreliminarymealbolus 15 ICRatio Reversecorrectionboluscalculation IftheReverseCorrectionfeatureis turnedonandifyourcurrentBGisbelowyourTargetBGbutaboveyour MinimumBGforCalcs theBolusCalculatorsubtractsacorrectionamount fromthepreliminarymealbolus Mealboluswithreversecorrection Reversecorrect...

Page 164: ...onspreventsthedeliveryoftoomuch insulinwhencorrectingahighBGoreatingameal MealIOBexample Durationofinsulinaction 3hours Timesincepreviousmealbolus 2hours Previousmealbolus 4 5U 3hours 2hours x 4 5U 1 5UmealIOB 3hours Inotherwords twohoursafteryourpreviousmealbolus yourbodyhasused up3unitsofinsulinofthemealbolus Theremaining1 5unitsofinsulinare stillinyourbodyworkingtocoveryourmeal MealIOBisonlyuse...

Page 165: ... 1 15 CorrectionFactor CF 2 8 Carbintake 45gramscarbohydrate carbs MealIOB 0U CorrectionIOB 0U Correctionbolus 8 4mmol L current 5 6mmol L target 1Upreliminarycorrectionbolus 2 8 CF Mealbolus 45 carbs 3Upreliminarymealbolus 15 ICRatio Note ThereisnoIOB sothepreliminarycorrectionandmealbolusesare notreduced Suggestedbolusdose 1Ucorrectionbolus 3Umealbolus 4Uinsulin ...

Page 166: ... 8 4mmol L current 5 6mmol L target 1Upreliminarycorrectionbolus 2 8 CF Preliminarymealbolus 0 carbs 0Upreliminarymealbolus 15 ICRatio Correctionbolus 1Upreliminarycorrection 1UmealIOB 1UcorrectionIOB 0U Note Aboluscanneverbelessthanzero thereforethecorrectionbolusis zero andnot 1 However thereisoneunused remaining correctionIOB Mealbolus 0Upreliminarymealbolus 1UunusedcorrectionIOB 0U becauseabol...

Page 167: ...inarycorrectionbolus 5 6mmol L current 5 6mmol L target 0Upreliminarycorrectionbolus 2 8 CF Preliminarymealbolus 45 carbs 3U 15 ICRatio Correctionbolus 0Upreliminarycorrection 1UmealIOB 0UcorrectionIOB 0U becauseaboluscanneverbelessthanzero Mealbolus 3Upreliminarymealbolus 0UunusedcorrectionIOB 3U Note AmealIOBisneversubtractedfromamealbolus Itisonlysubtracted fromacorrectionbolus Suggestedbolusdo...

Page 168: ...Carbintake 60gramscarbohydrate carbs MealIOB 0U CorrectionIOB 1U Preliminarycorrectionbolus 8 4mmol L current 5 6mmol L target 1Ucorrectionbolus 2 8 CF Preliminarymealbolus 60 carbs 4U 15 ICRatio Correctionbolus 1Upreliminarycorrection 0UmealIOB 1UcorrectionIOB 0U Mealbolus 4Upreliminarymealbolus 0UunusedcorrectionIOB 4U Suggestedbolusdose 0Ucorrectionbolus 4Umealbolus 4Uinsulin ...

Page 169: ...nonboardfromapreviouscorrectionbolus isthensubtractedfromthecurrentcorrectionbolus ifanyremains until thecorrectionbolusiszero Atthatpoint anyremainingcorrectionIOBis subtractedfromthecurrentmealbolus Thecalculatedinsulinonboardisroundeduptothenearest0 05U Areversecorrectiononlyoccursifthemealbolusisgreaterthan0 00U IfyourbloodglucosevalueisbelowyourTargetBGvalueandReverse Correctionison therevers...

Page 170: ...5 increments CannotexceedMaximumBasal Rate Tempbasal settoU hr Range 00U hr Off toMaximumBasalRate Tempbasalpresets 7 BGGoalRangefor bloodglucosehistory Lowerandupperlimits 3 9to11 1mmol Lin0 1 mmol Lincrements BGreminder OnorOff DefaultisOff Maximumof4activeatonetime Remindercanoccurbetween30minto4hrsafter bolusisstarted Setin15 minuteincrements Customreminder Maximumof4 SettoDaily Onetimeonly Of...

Page 171: ... Defaultis10 0U Podexpiration notification 1to24hoursin1 hourincrements Defaultis4hours Auto offtimer Off or1to24hoursin1 hourincrements Defaultis Off PDMlock OnorOff DefaultisOff Historystorage 5400records 90days Pod Specifications Size 3 9cmwidex5 2cmlongx1 45cmhigh 1 53 x2 05 x0 57 Weight withoutinsulin 25grams 0 88oz Operatingtemperaturerange Podoperatingenvironmentof4 4 Cto40 C 40 Fto104 F No...

Page 172: ...efaultconditions 0 0U FlowCapability Basal Programmablebytheuserin0 05Uincrementsupto30 0Uperhour Bolus Rate 1 5Uperminute Doserangefrom0 05to30 0U Deliveryaccuracy testedperIEC60601 2 24 Basal 5 atrates 0 05U hr Bolus 5 forallsetvalues 0 05U OnePodwastestedateachconfiguration Accuracytestresults ThefollowinggraphshowstheflowaccuracyofthePod againstgiventimeperiods ThemeasurementsweremadeusingaPod...

Page 173: ...icpressure 696hPAto1062hPA Storageatmosphericpressure 703hPAto1062hPA Communicationdistance ThePDMandPodshouldbe Atstartup Adjacentandtouching eitherinoroutoftray toensureproper communicationduringpriming Duringnormaloperation Within1 5m 5feet ofeachother Waterproofrating IP22 avoidliquid Alarmtype Audible Output 50db A at1meter Notificationtype Audibleandvibratory Built in BG Meter Specifications...

Page 174: ...hreedifferentsituationswhen usingU 100insulin Forexample ifthePod scannulabecomesoccludedwhen deliveringa5Ubolus between153secondsand35minutesmaypassbeforethe Podsoundsahazardalarm TimebetweenocclusionandPodalarm Minimumtime Typicaltime Maximumtime 5 00Ubolus 153seconds 33minutes 35minutes 1 00U hrbasal 1 5hr 3 0hr 5 5hr 0 05U hrbasal 20hr 51hr 80hr Podexpiration Ifanocclusionspontaneouslyclearsup...

Page 175: ...emaccuracyforfingersampleswithYSIglucoseresultsof5 55mmol Lor higher Within 5 Within 10 Within 15 323 483 66 9 440 483 91 1 477 483 98 8 Systemaccuracyforglucoseconcentrationsbetween2 22mmol Land 27 8mmol L Within 0 83mmol Lor 15 677 684 99 0 Astudy evaluatingglucosevaluesfromfingertipcapillarybloodsamples obtainedby590laypersonsshowedthefollowingresults 98 1 within 0 83mmol LoftheYSIreferenceatgl...

Page 176: ...iagnostics settings Up Down oncolor Tempbasal Status Suspend cancel Textentryright BasalProgram Submenu Hazardalarm Alternating flashingimage Homescreen Advisoryalarm Applybloodsample Bloodglucoserecords Alert Insulingauge Batteryfull SetupWizard Battery3 4full PDMlock Battery1 2full Information Support Battery1 4full Myrecords Batteryempty Lost historyrecord ...

Page 177: ...Symbol Meaning SingleUse MRUnsafe Caution Consult UserGuide Non pyrogenicfluid path Followinstructions foruse Donotuseifpackageis damaged Sterilizedusing ethyleneoxide TypeBFappliedpart Dateof manufacture Manufacturer Batchcode Keepdry Useby Temperaturelimit Referencenumber StorageRelative Humidity Serialnumber StorageAtmospheric pressure 2 Submersibleto7 6 meters 25feet for upto60minutes Authoriz...

Page 178: ...snotexpresslyapprovedbyInsuletCorporationcould voidtheuser sauthoritytooperatetheequipment BoththePodandthePDMgenerate use andcanradiateradiofrequencyenergy andmaycauseharmfulinterferencetoradiocommunicationsofotherdevices Therearenoguaranteesthatinterferencewillnotoccurinaparticularinstallation IftheOmnipod Systemdoescauseharmfulinterferencetoradioandtelevision reception theinterferencemaybecorre...

Page 179: ...anagementSystemis incompliancewiththeessentialrequirementsandotherrelevantprovisionsof RadioEquipmentDirective 2014 53 EU ThefullDeclarationofConformity canbefoundatthefollowingwebaddress http myomnipod com Red_Doc Warning Cablesandaccessoriesnotspecifiedwithintheinstructions forusearenotauthorized Usingothercablesoraccessoriesmayadversely impactsafety performance andelectromagneticcompatibility i...

Page 180: ...sequipmentisintendedforuseintheelectromagneticenvironmentspecifiedbelow The userofthisequipmentshouldassurethatisusedinsuchanenvironment Emissions Compliance accordingto Electromagneticenvironment RFEmissions CISPR11 Group2 ThePodandthePDMemitlowlevel electromagneticenergy RF inorderto communicate Althoughunlikely nearby electronicequipmentmaybeaffected CISPRB Emissions Classification ClassB TheSy...

Page 181: ...z 10V m PortableandmobileRFcommunications equipmentshouldbeusednoclosertoany partoftheSystemthantherecommended separationdistancecalculatedfromthe equationapplicabletothefrequencyofthe transmitterasbelow Recommendedseparationdistance d 1 17 P150KHzto80MHz d 0 35 P80MHzto800MHz d 0 7 P800MHzto2 5GHz wherePisthemaximumoutputpower ratingofthetransmitterinwatts W accordingtothetransmittermanufacturer ...

Page 182: ...stem Youcanhelppreventelectromagneticinterferencebymaintainingaminimum distancebetweenportableandmobileRFcommunicationsequipment transmitters andtheSystem asrecommendedbelow accordingtothe maximumoutputpowerofthecommunicationsequipment Rated maximum outputpower oftransmitter inwatts Separationdistanceaccordingtofrequencyoftransmitter inmeters 150kHzto80MHz d 1 17 P 80MHzto800MHz d 0 35 P 800MHzto2...

Page 183: ...etermsandconditionsbelow Insuletwarrantstoyou theoriginal recipientoftheOmnipod System thatifInsuletdeterminesthatanOmnipod SystemPod Pod youhavereceivedhasadefectinmaterialorworkmanship whileutilizedundernormaluseandconditionsduringtheperiodofeighteen 18 monthsfromthedateofmanufactureandseventy two 72 hoursfromthe timeofactivation Insuletwilleitherrepairorreplace atitssoleoption thatPod Tobeeligi...

Page 184: ...ithapriorauthorization Insuletwillpayallreasonablepackagingandpostage charges whereapplicable incurredinshippingthePodorthePDMtoInsulet underthisWarranty Fortheavoidanceofdoubt thisWarrantydoesnotcover repairsperformedorreplacementsprovidedbyanypersonorentityotherthan Insulet exceptthoseperformedorprovidedbythirdpartiestowhichyouwere explicitlyreferredbyInsulet ProofofPurchase ReceiptorActivation ...

Page 185: ...Mand thePodsandallotherstatutoryandimpliedwarrantiesareexpressly excludedtothemaximumextentpermitted Insulet itssuppliers distributors serviceproviders and oragentswill notbeliableforindirect special incidentalorconsequentialdamages causedbyadefectinthePDMoraPodorbyabreachofthisWarranty whethersuchclaimisbasedinwarranty contract tortorotherwise NothinginthisWarrantyisintendedtoexcludeourliabilityf...

Page 186: ...ntapplicabletoaPDM aPod oranOmnipod Systeminadditionto thosemadeintheforegoing ConsenttoDisclaimerofImpliedWarrantiesandtheLimitationofRemedies IfyoudonotconsenttoandinsteadwishtorejecttheDisclaimerofImplied WarrantiesandtheLimitationofRemediesincludedalongwiththeOmnipod System pleasereturnanyOmnipod Systemproducts includinganyPDM andPod toInsuletinexchangeforafullrefund Failuretoreturnsuchproduct...

Page 187: ...172 Thispageintentionallyleftblank ...

Page 188: ...ered BGGoalRange Auser definedrangeofdesiredbloodglucosevalues Thisrange isusedinthehistoryrecordstoindicatewhichbloodglucosevaluesfallwithinthis range Bloodglucose Bloodglucoselevel Theamountofglucose orsugar inthe blood Bloodglucosemeter Adeviceusedtocheckbloodglucosecontent BolusCalculator Afeaturethatsuggestsmealandcorrectionbolusdosesbased onyourcurrentbloodglucose amountofcarbohydratesyouare...

Page 189: ...edbyhyperglycemia high bloodglucose resultingfromthebody sinabilitytousebloodglucoseforenergy Intype1diabetes thepancreasnolongermakesinsulinandthereforeblood glucosecannotentermanycelltypestobeusedforenergy Intype2diabetes eitherthepancreasdoesnotmakeenoughinsulinorthebodyisunabletouse insulincorrectly Diabeticketoacidosis DKA Aseriousconditioninwhichextremelyhigh bloodglucoselevelsandaseverelack...

Page 190: ...rmallevelofglucoseinthe blood generallybelow3 9mmol L Hypoglycemiaunawareness Aconditioninwhichapersondoesnotfeelor recognizethesymptomsofhypoglycemia Infusing Introducingaliquidsubstanceundertheskinintothebody Infusionsite AplaceonthebodywhereaPod scannulaisinserted Insulin Ahormonethathelpsthebodyuseglucoseforenergy Thebetacellsofa healthypancreasmakeinsulin ICRatio Insulin to CarbohydrateRatio ...

Page 191: ...shighinprotein includemeat poultry fish legumesanddairyproducts Reversecorrection negativecorrection Ifyourbloodglucoselevelisbelow yourTargetBG theBolusCalculatorusesyourCorrectionFactortoreducea portionofamealbolusdose Thisisanoptionalfeature whichshouldbeturned onoroffaccordingtotheadviceofyourhealthcareprovider Sensitivityfactor seeCorrectionFactor Softkey AbuttononthePDMwhoselabelorfunctionap...

Page 192: ...suspend or resume 59 switch 58 basal rate 138 173 flow 157 maximum 64 temporary 55 58 139 basal records 88 89 basal segment 19 138 173 batteries insert 14 level indicator 7 low 100 112 preserve 63 replace 112 type 112 BG Goal Range 82 173 BG meter built in 173 beeps 83 error messages 106 results 42 43 44 specifications 158 tag readings 45 82 using 37 44 BG meter separate 44 BG reminders setting 77...

Page 193: ... alarms 63 BG meter 36 PDM 137 Pod 134 cleaning PDM 114 Pod 110 clock AM PM or 24 hour 15 61 code number test strip vial 38 communication failure 102 range 27 133 136 Confidence reminders setting 80 control solution 35 36 39 41 Correct Above threshold 70 146 174 correction bolus 144 154 174 Correction Factor 72 145 174 correction IOB 146 149 CSII See continuous subcutaneous insulin infusion CT sca...

Page 194: ...us function check 134 G glucagon kit 119 123 graphs Basal Program 66 blood glucose history 91 H hazard alarms 96 header bar 7 hemoglobin A1c HbA1c 175 high BG reading 43 history See records Home Power button 4 Home screen 9 hospitalization 131 hyperglycemia 126 129 175 and BG reading 43 avoiding 126 symptoms 126 treating 127 hypoglycemia 121 125 175 and BG reading 43 avoiding 123 symptoms 122 trea...

Page 195: ...e Actions 9 Records 85 microwave ovens 111 Minimum BG for Calcs 71 146 176 minimum insulin amount 26 missed bolus reminder See bolus reminders model number i ix modify an ongoing bolus 51 More Actions menu 9 More Info indicator 7 MRIs 131 N navigating records screens 86 navigation shorthand 5 neonate x 176 notes 62 notifications 99 100 176 numbers entering 6 O occlusion 32 96 126 129 159 176 ongoi...

Page 196: ...rk indicator 7 R range BG Goal 82 range BG Goal 173 rapid acting insulin 129 records 85 94 alarms 92 all records 93 basal 89 basal bolus summary 88 blood glucose 90 bolus 88 carbohydrate 92 combined list 93 icons 87 insulin delivery 88 lost record 87 menu screen 85 personal contact information 93 selecting dates or list items 86 reminders BG 77 100 Bolus 78 Confidence 80 Custom 80 Program 80 101 r...

Page 197: ...ate 64 Maximum Bolus 75 Minimum BG for Calcs 71 146 Pod expiration 77 Program reminders 80 reset PDM 64 Reverse Correction 72 screen color 62 screen lock or unlock 63 screen time out 63 summary 155 Target BG 70 temp basal configuration 68 Temp basal preset 68 time 61 username 62 setup PDM 13 21 shorthand navigation 5 shut off alarm 108 sick days 130 silencing alarms 108 beeps 62 100 soft keys 4 17...

Page 198: ...M 158 Pod 24 156 test alarms 63 test strips x 35 37 code number 38 text entering 6 time and date 61 AM PM or 24 hr 61 time out backlight 63 screen 63 time segments 19 176 time zones 119 travel 119 121 turn on off PDM 4 typing text and numbers 6 U U 100 insulin xi unlock the screen 63 111 Up Down button 4 upper limit BG Goal Range 82 USB cable 99 112 user calculated bolus See manually calculated bo...

Page 199: ...DMsettings Rememberto updateyourinformationifyouchangeoraddsettings 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_____________ 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 3 Name_______________ Basalrate midnight to U hr to U hr to U hr to U hr to U hr to U hr to U hr B...

Page 200: ...timesegment 1unitofinsulin decreasesBG by 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 Basal Presets Name Rate circlemeasurement U hror U hror U hror U hror U hror U hror U hror Bolus Presets Carb Presets Name Units Name Gramsof carbohydrates U gcarb U gcarb U gcarb U ...

Page 201: ...My Notes ...

Page 202: ...s jurisdictions All rights reserved Patent information at www insulet com patents Printed in USA PDM imagery is for illustrative purposes only PDM screens may vary based on model or user settings Model ENT450 IPX8 up to 25 feet for 60 minutes PDM not waterproof 17845 5C AW Rev A 10 17 Insulet Corporation 600 Technology Park Drive Suite 200 Billerica MA 01821 USA Support Supplies 0800 011 6132 Omni...

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