Ypsomed OmniPod my life, User Manual

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Page 2: ...ax EmailAddress OmniPodSystemStartDate ____________________________ PDMModel ENT450UKSerialNumber __________________ Distributor YpsomedLtd UK BlackwoodHallBusinessPark NorthDuffield Selby N Yorks YO85DD United Kingdom info ypsomed co uk CustomerCare YpsomedLtd Service 08000926787 Doctor Nurse Educator Health Insurance Pharmacy Usethespacesbelow torecordimportanthealthandproduct information ...

Page 3: ...rightsreserved OmniPodisaregisteredtrademarkofInsulet Corporation U S PatentNo 6 740 059 FreeStyleisaregisteredtrademarkofAbbottLaboratories Third partytrademarks usedhereinarethetrademarksoftheirrespectiveowners 14518 5C AWRevA ...

Page 4: ...mary screens 6 Safety Features 8 Automatic priming safety checks and insertion 8 Occlusion detection 8 Alerts and alarms 8 2 Getting Started 9 The mylife OmniPod Starter Kit 9 Set Up the Personal Diabetes Manager PDM 9 Turn on the PDM 9 The Setup Wizard 10 Enter your PDM ID 10 Select the ID screen color 10 Set date and time 11 Enter basal settings 11 Enter blood glucose sound setting and BG goal 1...

Page 5: ...uggested bolus is calculated 30 Deliver a Normal Bolus 31 Deliver a bolus when suggested bolus calculator is On 31 Deliver a bolus manually suggested bolus calc is Off 33 Deliver an Extended Bolus 34 Deliver an extended bolus instead of a normal bolus 34 Cancel Active Boluses 36 Replace an Extended Bolus 36 Bolus Presets 37 Create a bolus preset 38 Enable an existing bolus preset 38 Change rename ...

Page 6: ... time out 73 Set Diagnostic Functions 73 Diagnostic options 74 Set a Reminder to Vibrate 75 Get the Most from Your PDM 75 Keep it handy 75 Communicating with the Pod 75 Water and your PDM 75 Avoid extreme temperatures 76 Electrical interference 76 7 Checking Your Blood Glucose 77 The Built in FreeStyle Blood Glucose Meter 77 The FreeStyle Blood Glucose Test Strips 78 Important test strip informati...

Page 7: ...vities 105 Check your blood glucose frequently 106 Inspect the infusion site daily 106 Prepare for Emergencies 107 Water and Your Pod 107 Traveling and Vacationing 108 Plan for changing time zones 108 Take enough supplies 108 Minimize airport security delays 108 Keep supplies accessible 109 Avoid lows highs and DKA 110 General precautions 110 Hypoglycemia Low Blood Glucose 110 Symptoms of hypoglyc...

Page 8: ...ge and Supplies 141 Suggested Bolus Calculator Examples and Guidelines 142 Meal bolus calculation 142 Insulin on board IOB calculation 142 Calculator guidelines 144 mylife OmniPod System Options and Settings 146 Pod Specifications 147 Accuracy Test Results 148 Flow rate from startup 148 Flow rate error 148 Personal Diabetes Manager Specifications 149 Blood Glucose Meter Specifications 149 mylife O...

Page 9: ...essfuluse of themylifeOmniPod InsulinMan agement System This UserGuide isintendedforuseonlywithPDM modelENT450 TolearnwhichversionofthePDM youhave turnitover OnthebackofthePDM look for ENT450 Ifyouseeit thisis thecorrectUser Guide Ifyoudonotsee ENT450 onthebackofthe PDM pleasecallCustomerCare This UserGuide isperiodicallyupdated VisittheCus tomerCaresectionofmylife omniPod com tosee themostrecentv...

Page 10: ...providertodeterminetheappropriatesettingsfor you Convention Term Meaning Bold Namesofbuttons softkeys menus and screensareinbold Italics Wordsinitalicsaredefinedinthe Glossaryattheend ofthisUserGuide Press Pressandreleasea button orsoftkey Hold Keeppressingabuttonuntilitsfunctionis complete Menu AlistofoptionsonthePDM Optionsallow youtoperform tasks Screen Displaysprogramming operating and alarm a...

Page 11: ...gof orscreeningfordiabetesmellitus ThemylifeOmniPodSystem isdesignedto use rapid acting U 100insulin ThefollowingU 100 rapid acting insulinanalogshavebeentestedand foundto besafeforuseinthePod Novolog Novo Rapid Humalog orApidra Novolog iscompati blewiththemylifeOmniPodSystemforuseupto72 hours 3days Beforeusingdifferentinsulinswith themylifeOmniPodSystem checktheinsulindrug labeltomakesureitcanbe ...

Page 12: ...theuser Ifyouarehaving symptoms thatarenot consistent withyourbloodglucosetestand youhavefollowed allinstructions describedinthisUserGuide callyour healthcareprofessional YourRole SafelyUsingthemylifeOmniPod System Workwithyourhealthcareproviderto establishdiabetesman agementguidelinesandsettingsthatbestfityourneeds These may include Insulin to CarbohydrateRatio IC Numberofgrams ofcar bohydratecov...

Page 13: ...m do not hesitateto talkwithyourhealthcareprovider Fornonmedicalemergencies orfortechnicalquestionsabout yourmylifeOmniPodSystem setuporoperation you cancallCustomerCare24hours aday 7 daysaweek CustomerCare YpsomedLtd Service 08000926787 Yourhealthcareproviderwill giveyouallthetoolsandtraining youneedto besuccessfulwiththemylifeOmniPod InsulinMan agementSystem However intheend yoursuccessdependson...

Page 14: ...ibility andease ofuse Continuousinsulindeliverymostcloselymimicstheinsulin releaseofahealthypancreas Sincethelandmark10 year DiabetesControlandComplicationsTrial DCCT thelong termhealthbenefitsofmaintainingnear normalblood glucoselevelshavebeenwidelyrecognized Continuousinsulindeliveryat presetrateseliminates theneed forinjectionsandtheinterruptionsthatcomewiththem Inaddi tion withthemylifeOmniPod...

Page 15: ...us you llenjoy thesafety convenience andfreedomof Notubing ThereisnotubingconnectingthePodtothePDM Youwearthe Podcomfortablyanddiscreetlyunderyourclothes Youcancarry thePDMseparatelyina backpack briefcase orpurse Withthe mylifeOmniPodInsulinManagement System youdon thaveto worryaboutsnagging tangling orfeeling tetheredbytubing Suggestedboluscalculation Calculating bolusdoseshas neverbeeneasier Aft...

Page 16: ...cancheckyourblood glucose levelusingFreeStyle bloodglucosetest strips but withoutthe hassleofcarryingaseparatebloodglucosemeter Ifyou preferto useanotherbloodglucose meter youcan enter thereadingsmanuallyintothePDM Recordkeeping AnotherconvenientpartofthemylifeOmniPodSystemisrecord keeping Paperchartsareuseful but sometimestheycanbe inconvenienttocarryoruse Thedatastoragesystem inthe PersonalDiabe...

Page 17: ...andage ThePersonalDiabetesManager AllPodoperationsareprogrammedandcontrolledthroughthe palm sizedPersonalDiabetesManager PDM Figure1 2 Top Bottom Needle cap Viewing window Fill port Figure 1 1 Adhesive backing Housing vent Figure 1 2 Up Down Controller User Info Support Soft Key Label Soft Keys Home Power USB Port Test Strip Port LCD Screen ...

Page 18: ...ys Softkeylabelsandfunctionsdependonthe menu orscreenyouareviewing Thelabel appears onthescreendirectly abovethephysi calbuttonyoupress Select Save andBackare justthreeexamplesofthesoftkeylabelsonyour PDM Button Action UserInfo Support PressingopensaUserInfo Supportscreenthat displays additionalinformationabout thecur rentscreenyouareviewing TheUserInfo Sup porticonappears whenadditionalinformatio...

Page 19: ... tomizingyourPDM Youmustacknowledge the IDscreen beforeyoucanusethePDM Itisimportantthatyoualwaysiden tifythePDMasyours beforeyou useit Statusscreen ListstheSystem scurrent operatingstatus Figure1 4 Fromtopto bottom theStatusscreendisplays Time date andresult oflastbloodglucosecheckedor enteredmanually Time date andtotalamountoflast bolusdelivered Amount of Insulin on Board IOB will be displayed o...

Page 20: ...ours old Tempbasalmenutodelivertemporarybasalrates This submenu doesnotappeariftempbasalisturned Offin Settings Myrecordsmenu toreviewinsulindelivery bloodglucose history alarmhistory carbhistory andpersonaluserinforma tion Settingsmenuto edit enter andnamebasalprograms tempbasal carbohydrateand boluspresets andto custom izeSystemsettings Suspend menu tosuspend cancel orresumeinsulin deliveryprogr...

Page 21: ...vateandchangeyour Pod seeChapter5 UsingthePod Ahazardalarmsoundswhenanaverageof3to5unitsofmissed insulinoccurs Thistabledepictsocclusiondetectionfor3 differ entsituationswhenusingU100insulin Ifanocclusioniscleared avolumeofinsulincouldbereleased Thatvolumewouldnot exceed3 9U Alertsandalarms Foryoursafety themylifeOmniPodSystemprovidesa rangeof alertsandalarmsto tellyouthatyourattentionisneeded ort...

Page 22: ...sindetail Theinstructions inthischapteraresimplifiedtohelp yougetstarted TurnonthePDM 1 Openthebattery compartmentonthebackofthePDM bypushingthecompartmentlatchand liftingupward Figure2 1 Nospecialtools arenecessary DoNOTusetheOmniPod InsulinManagement Systemuntilyouhavebeentrainedbyyourhealthcare provider HeorshewillinitializetheSystembasedon yourindividualneeds Inadequatetrainingorimproper setup...

Page 23: ...through the listofcharacters Anup and down arrow symbolonthe screenindicatesthecharacteryou arechanging 2 Press themiddleSoftKey labeledwiththeright arrow to movetheunderscoretothenext character 3 Entereachcharacteroneatatime Forexample ifyou want toenteryourname youmightenterJ a n e space S m i t h Ablankcharacterorspaceis thefirstandlastoptioninthe scrollingmenu 4 Press Next SelecttheIDscreencol...

Page 24: ...and AdjustingBasalRates 4 Toseethebasalprogramasalist press List To returntothe graphicview pressGraph 5 Press Saveto acceptthebasalprogram youhaveset 6 Chooseatemporarybasalfeature thenpressNext Choose toshow temporarybasalratesasapercentincreaseor decreaseofyourcurrent basalrate ChooseU hrtoshow temporary basalratesinunits perhour OrchooseOffto turn offthetemporarybasalfeature Fordetailsaboutset...

Page 25: ...rthe cor rect above valueor correctionthreshold theBGvalue abovewhichyouwantthePDM to suggest acorrection bolus thenpressNext e Whenyouhavefinishedentering segments press Done 4 Toseethesegments asalist pressList Toreturnto the graphicview pressGraph 5 Press Savetoacceptthetarget BGprofileyouhaveset EnterminimumBGallowedforuseinboluscalculation 1 UsetheUp DownControllerbuttons toentera minimum blo...

Page 26: ...factors forupto8timesegments Toenteradditionalcorrectionfactors choose addnew then a Press New b Enterastart timeforthesegment thenpress Next c Enteranendtimeforthesegment thenpressNext d Enterthecorrectionfactor thenpressNext e Tosavethenewcorrectionfactorsegment press Done 3 Toseethefactorsasalist press List To returntothegraphic view pressGraph 4 Press Savetoacceptthecorrectionfactorsyouhaveset...

Page 27: ...rofhoursbeforeaPodexpireswhenthe PDM shouldgiveyou anotification thenpress Next The valuesarein1 hourincrementsandrangefrom1to24hours Thedefault is4hours ThePDM askswhetheryouwanttoactivateaPod Press Yesifyouareready toactivateanew Pod SeeChapter 5 UsingthePod tolearnhowtoactivateanew Pod Press Noifyoudo notwant toactivateaPodatthistime The PDM displaystheHomescreen Theduration of insulin actionse...

Page 28: ...fertoChapter5 UsingthePod for detailedinstructions You maywanttoadjustthePDM screentime out andbacklighttime out Formoreinformationon howtodo this seeChapter6 UsingthePersonal Diabetes Manager Usetheform attheendofthisUserGuidetowrite downallyoursettingsfromtheSetupWizard Ifyou everneedtoresetorreplaceyourPDM having thesesettingshandywillmakesetupveryeasy ...

Page 29: ...uringtheearlymorningandalowerrate during thelateevening Abasalprogramdescribestheamount ofinsulintobedeliveredduringanentire24 hourperiod Abasalprogramcontains at leastonebasalrateforthe24 hour period but formost peopleitwillbebrokenintoseveraltime segments orbasal segments eachdeliveringadifferent rateof insulin Asamplebasalprogram withthreebasalsegments might be Approximately50 ofaperson stotald...

Page 30: ...salprogram ThePersonalDiabetes Managercanstoreupto 7differentbasal programs Eachprogramcancontain24rates programmedin half hourincrements Onceyouentera basalprogram intothe PDM you onlyneed topressafew buttonstopicktheprogram youwant ThePodcontinuestodeliverinsulinatthoseratesuntil youchangethat programor switchtoanotherone 1 OntheHomescreen usetheUp DownControllerbuttons to chooseSettings thenpre...

Page 31: ...ortheentire24 hourprogram press Doneand continuewithstep7 Or toaddbasalsegmentsandrates forexample ahigher basalratebetween8 00amand3 00pm a Chooseanexistingbasalsegment thenpressEdit Or choose addnew thenpressNew b Enterthestarttime forexample 8 00am thenpress Next Basalsegments arein30 minuteincrements c Entertheendtime forexample 3 00pm thenpress Next d Entertherateforthenewbasalsegment forexam...

Page 32: ...mory pressSave Repeatsteps1through9 above foreachbasalprogram upto7 programs you wanttocreate Enableanexistingbasalprogram 1 OntheHomescreen usetheUp DownControllerbuttons to chooseSettings thenpressSelect 2 ChooseBasalprograms thenpressSelect Basalratesoutsidethechangedsegmentdonot change Press andholdthePowerbuttontoturnthescreen backon Insomecases ifithasbeenless than5 minutessincethescreentime...

Page 33: ...ns to chooseSettings thenpressSelect 2 ChooseBasalprograms thenpressSelect 3 Choosea programfromthelist thenpressSelect Toviewthesegmentsofthebasalprogram 1 ChooseView thenpressSelect Figure3 8 Figure 3 7 Adiamondicon appearsnexttotheprogramthat isactive You cannotselecttheactiveprogram to enableit becauseitis alreadyrunning Asa safety feature youcannot enableanew basal program whileatemporarybasa...

Page 34: ...4 Enteranendtimeforthis segment thenpressNext 5 Enterabasal rateforthenewsegment thenpressEnter 6 Tosavethenewlyenteredsegmentintothebasalprogram pressSave Figure3 10 Ifyouwanttomakeadditionaledits repeat steps2 5 7 Toseetheprogramasalist pressList Toseethegraphagain press Graph Asasafetyfeature youmustsuspendinsulindelivery beforeeditinganactivebasalprogram seeChapter 5 UsingthePod Remembertoresu...

Page 35: ...press Select 2 Press Delete to permanentlydeletetheprogram TemporaryBasalRatesandPresets Whatisatemporarybasalrate Atemporary basalratelets youadjustyourbasalrateforapre determinedperiodoftime Onoccasion youmayneedtochangetheactivebasal ratefor onlyashorttime Forexample ifyou aregoingcross country skiing forseveralhours youmaywanttolowerthebasalrate during andafteryou exercise Thisiscalleda one ti...

Page 36: ...eate a temp basal of 60 Seethesectionsbelowoncreating enabling cancelling and changingtemporarybasalpresets Enableaone timetemporarybasalrate 1 OntheHomescreen usetheUp DownControllerbuttons to chooseTempbasal thenpressSelect 2 Ifyou havecreatedtempbasalpresets choose entermanu ally fromthelist thenpressSelect Ifyouhavenotcreatedanytempbasalpresets thePDMskips thisstep 3 Enterthetemporarybasalrate...

Page 37: ... TousethemylifeOmniPodSystem sdefaultnaming system simplypressNext Thedefaultnamingsystemautomatically assignsprogramnames innumericalorder suchastemp basal1 tempbasal2 tempbasal3 Or togiveadifferentnametotheprogram a Press theUp DownControllerbuttonsto scrollthrough thelistofcharacters Anup and downarrowsymbolon thescreenindicates thecharacteryouarechanging b Press themiddleSoftKey to movetheunde...

Page 38: ...eptit Enableanexistingtemporarybasalpreset 1 OntheHomescreen usetheUp DownControllerbuttons to chooseTempbasal thenpressSelect 2 Choosethetemporarybasalpresetyouwanttousefromthe list Figure3 15 thenpress Select 3 Ifyou want changethedurationforthetemporaryrate in half hourincrements thenpressEnter Figure3 16 4 Press Confirmtobeginthetemporary basalrateshownon thescreen ThePodbeepstoindicatethatthe...

Page 39: ...Controllerbuttons tochooseSettings thenpressSelect 2 ChoosePresets thenpressSelect 3 ChooseTempbasalpresets thenpressSelect 4 Chooseatemporarypresetfrom thelist thenpressEdit Tochangeatemporarybasalpreset 1 ChooseEdit thenpressSelect Figure3 17 2 Enteranewrate ornew percentchange forthepreset thenpressNext 3 Enteranewdurationforthepreset thenpressSave 4 PressDone Ifyoususpendinsulindeliverywhileat...

Page 40: ...mitsthebasal rate U hr thatthePod candeliver Onceyouenteritintothe PDM memory themaximumapplies tobothregularbasalpro gramsandtemporarybasalrates You andyourhealthcareproviderwillenteraninitialmaximum basalrateintoyourPDM during thesetupprocess seeChapter 2 GettingStarted You canchangeit laterasyoufine tune your Systemsettingsorwhenyourneedschange Changethemaximumbasalrate 1 OntheHomescreen usethe...

Page 41: ...Theamount of insulinonboard IOB activeinsulin frompre viousmealandcorrectionboluses Yourcorrectionthreshold theBGlevelabovewhichyou wouldliketotakeinsulin toreduceanelevatedblood glucose Youractivitylevel Thetypeandamount offood youeat WiththemylifeOmniPodSystem itis easytoadapt to anysitua tion With justafew buttonpresses youcan adjust to unexpectedorchanginginsulinneeds Duringsetup you enteredbo...

Page 42: ...eeChapter6 Usingthe PersonalDiabetes Manager Ifthesuggested boluscalculatoris turned On theSystem automaticallycalculatesabolusdose Ifthesuggested bolus calculatoristurnedOff you mustenterabolusamount manually Whenusingtheextendedbolus functiontheuser shouldchecktheirbloodglucoselevelsmorefre quentlyto avoidhypoglycemiaorhyperglycemia Thebolus featuresinthemylifeOmniPodSystem are designedforflexib...

Page 43: ...s thenamesuggests corrects forabloodglucose BG levelaboveyourtargetBG level Mealbolus Themealbolusprovidesinsulinforthecarbohy drates youenterintotheSystem Insulinonboard IOB InsulinonBoard IOB theamountof insulinstillworkinginyourbodyfrompreviousmealandcorrec tionboluses Theamountoftimetheinsulin remains onboard or active depends onwhatyou set foryourdurationofinsulin action Forformulasforeachele...

Page 44: ...ncludeit in thesuggested bolus calculator Whenyourbloodglucoseresultreads HIGH or LOW thesuggestedbolus calculatorwill be disabled Ifyou useaseparatebloodglucosemeter notthe PersonalDiabetes Manager PDM youwillneedto enteryourbloodglucosemanually OntheHome screen chooseBolus thenpress Select UsetheUp DownController buttons toenteryourcurrentBG value thenpressYesifyouwantthisvaluetobeused bythesugg...

Page 45: ...ter UsetheUp DownControllerbuttonstochoose favorites snacks ormeals From there selectacarb presetyouhavepreviouslyentered see CarbPresets laterinthischapter thenpressSelect b Press Entertoacceptthesuggested bolus Figure4 6on thefollowingpage OrpresstheUserInfo Support buttontoviewcalcula tioninformationusedforthissuggestedbolus Press Closetoreturnto theSuggestedBolusscreen then press Enter IntheSu...

Page 46: ...IfthereversecorrectionfeatureisturnedOnandif yourbloodglucoselevelis belowyourtarget the Systemsubtractsacorrectionamountfrom themeal portionofthebolus IfthereversecorrectionsettingisturnedOff the Systemdoesnotsubtractanythingfora bloodglu coselevelbelowyourtarget Figure 4 6 Asa safety feature themylifeOmniPodSystemonly allowsyoutogiveabolus atorbelowthemaximum bolus doseyou haveset SeeChapter6 Us...

Page 47: ... insteadof Enter seeFigure4 7 2 Entertheunitsofinsulinorpercentageof thebolusthat you wanttotakeimmediately Figure4 8 thenpressEnter Figure 4 7 Ifyou havesettheExtendedbolusoption to Off thePDMwillnot displaytheExtend SoftKey For informationonturningthisfeatureOnandOffsee Chapter6 Using thePersonalDiabetesManager Tolearnhowtosetextendedbolusesinpercentages orunits seeChapter6 UsingthePersonalDiabe...

Page 48: ...Asa safety feature thecorrectionbolusis always deliveredfirstandcannotbeextended Onlythe mealboluscanbeextended Forexample Totalbolus 5units Correctionbolus 1unit Mealbolus 4units Delivernow 2units correctionbolus 1unit mealbolus 1unit Extend 3units mealportion 3units Asa safety feature youcannot delivertwoextended bolusesatthesametime You can however cancel thefirstextendedbolusand replaceitwitha...

Page 49: ...pstoconfirmthebolusiscancelled Anon screen messagetellsyouhow muchinsulinwasdelivered before youcancelledthebolus Figure4 12 3 Press OKtoreturnto theStatusscreen ReplaceanExtendedBolus You canreplaceoneextendedbolus withanother TheSystem tellsyou howmuchofthefirstbolushasnot yet beendelivered 1 Afteryouseeyoursuggestedbolus pressExtendinsteadof Enter seeFigure4 7onPage34 Figure 4 11 Figure 4 12 If...

Page 50: ...reen BolusPresets Bolus presetsarebolusamountsthatyouprogramforfrequent use Forexample ifyouoftentakethesamebolus at lunchtime youcancreateaboluspreset forthatamountandnameit Lunch You canaddwhatremainedoftheoldextended bolus tothenew one Figure 4 13 Figure 4 14 Bolus presetsareavailableonlywhenthesuggested bolus calculatorfeatureisturned Off Ifthesuggested bolus calculatoristurnedOn you canstillu...

Page 51: ...ichcharacter youarechanging b Press themiddleSoftKey labeledwiththeright arrow to movetheunderscoretothenextcharacter c Entereachcharacteroneatatime Forexample ifyou frequentlytakethesamebolusat lunchtime you might enterL u n c h Figure4 16 d Press Next 6 Enterthenewboluspresetamount uptothemaximum bolus youenteredduringsetup thenpressNext 7 Reviewtheboluspresetnameandamount thenpress Save to acce...

Page 52: ...eckthePodstatus refertoPage54fordetailedinstruc tions TheIDscreenmustbeconfirmedbeforeyoucancheck Podstatus ifitisnotalready on Anon screenmessage appears aslongasabolusis beingdelivered 2 Press Cancel ThePodbeepstoconfirmthebolusiscancelled Anon screen messagetellsyouhow muchinsulinwasdelivered before youcancelledthebolus 3 Press OKtoreturnto theStatusscreen Formoredetails see CancelActiveBoluses...

Page 53: ...ndcinnamon you might enter B l u e space Y o g u r t Figure4 18 d Press Next 7 Enterthegramsofcarbohydrateinthemeal thenpressNext 8 Ifyou want enterthegramsoffiber fat andproteininthe meal andthetotalcalories PressNext aftereachentry 9 Press Savetoaddthepreset to thecategory Changeoreditacarbpreset 1 OntheHomescreen usetheUp DownControllerbuttons to chooseSettings thenpressSelect 2 ChoosePresets t...

Page 54: ...ofthecharacters whichgivesyou theoptionto chooseablankspace 4 Enterthegramsofcarbohydrateinthemeal thenpressNext 5 Ifyou want enterthegramsoffiber fat andproteininthe meal andthetotalcalories PressNextaftereach entry 6 Press Savetoupdatethepreset Deleteacarbpreset 1 OntheHomescreen usetheUp DownControllerbuttons to chooseSettings thenpressSelect 2 ChoosePresets thenpressSelect 3 ChooseCarbpresets ...

Page 55: ...magedinanyway Adam agedPodmaynotworkproperly To minimizethepossibilityofsiteinfection doNOT applya Podwithoutfirstusingaseptictechnique This meansto washyourhands cleantheinsulinvialwithanalcoholprepswab cleantheinfusionsitewithsoap andwater keepsterilematerialsawayfromanypossiblegerms DoNOTuseaPodifyou aresensitivetoorhaveallergiesto acrylicadhesives orhavefragileoreasilydamaged skin Checkoftento...

Page 56: ...g on pagex oftheIntroductionforalistofinsulin sapprovedfor useinthemylifeOmniPodSystem AnunopenedPod Analcoholprep swab DeactivatethecurrentPod 1 OntheHomescreen usetheUp DownControllerbuttons to chooseMoreactions thenpressSelect 2 ChooseChangePod Figure5 1 thenpressSelect 3 Press Confirm Figure5 2 to deactivatethecurrentPod NEVERuseinsulinthatiscloudy itmaybeoldorinac tive Failuretouserapid actin...

Page 57: ...theadhesivetapefrom yourskin andremovetheentirePod Figure5 5 b Usesoapandwatertoremoveanyadhesivethatremains ontheskinor ifnecessary useanadhesiveremover c Discardtheused Podaccordingtolocalwastedisposal regulations 6 Afterremovingtheold Pod pressNext 7 PressYesto fillandactivateanewPod Figure5 6 RemovingthePodslowlywillhelptoavoid possibleskinirritation Figure 5 3 Figure 5 4 Checktheinfusionsitef...

Page 58: ...iderwillhelpyou determinethe correct amount 5 Drawairintothesyringeuptotheamount of insulinyou want BeforefillingaPod ensurethat nootherPods are beingactivatedwithin 24inchesofyourPDM BeforefillingaPodwithinsulin ensurethatthePod isabove50 Fahrenheit 10 Celsius IfthePodhas beenexposedtotemperaturesbelow50 F 10 C thenallowthePodtobebroughtbacktoroom tem peraturebeforefillingitwithinsulin Usecareaft...

Page 59: ...eundersideofthePod Figure5 10 Anyairbubblespresent inthefillsyringecouldbe transferredintothereservoirduringthefillprocess Thepoddoesnotpurgeairthatisintroducedintothe reservoirbywayofcustomerfill Failuretoexpelairbubblesfromthefillsyringe mayresult in interruptedinsulin delivery Makesurethereis noairinthesyringebefore attempting tofillaPodwith insulin Besuretoonlyinsertthe fillsyringeintothefill ...

Page 60: ...asecallCustomerCare 14 TheSystemperformsaseriesofsafetychecksandautomati cally primesthePod Figure5 12 Oncecomplete thePDM beeps lettingyou knowthattheprimingandsafetychecks weresuccessful Donotuseanyothertypeofneedleorfilling devicebesidesthesyringeprovidedwitheach Pod NEVERuseaPodifyouhearacracklingnoiseor feelresistancewhenyoudepresstheplunger Theseconditionscanresult ininterruptedinsulin deliv...

Page 61: ...atthePodhasbeenfilled itwillbeep every5minutestoindicatethattimeispassing Ifyou do notsetupthePodwithin60minutes youmust deactivateanddiscardit Oncea Podisactivatedandcommunicates withthe PDM itcanonlyreceivecommandsfrom thatPDM not from anyother Figure 5 11 Figure 5 12 Avoidsiteswherebelts waistbands ortightclothing mayrubagainst disturb ordislodgethePod Also avoidsites wherethePodwill beaffected...

Page 62: ...Using the Pod 49 5 Figure 5 13 Adult Front Back Figure 5 14 Youth Front Back ...

Page 63: ...infusion site 5 Let thesiteair drythoroughly Donotblowonthesitetodry it ApplythenewPod PreparethePod forapplyingtoyourinfusionsite 1 ToremovetheneedlecapontheundersideofthePod place yourthumb onthebottom flat edge oftheneedlecapand pullit upwards Figure5 15 Theneedlecapwillsnapoff 2 Verify thatthePod isreadytobeapplied Podiscleananddry Adhesivepadisintactandundamaged Tohelpavoidcondensationfromocc...

Page 64: ...epreparedinfusionsite Pressfirmlyto secureittoyourskin Verify cannuladoes not extend beyondadhesivebackingonce needlecapisremoved Do notremovetheneedlecapuntilyouare instructedto doso bythePDM Whenyouremove the needlecap adrop ofinsulinmaybevisible atthe endofthecannulaorinthewell ForthePodtoworkbest apply it a Crosswiseorataslightangleonyourabdo men hip lowerback orbuttocks inFigure5 17 b Upanddo...

Page 65: ...bout theseproducts Avoidgettingbody lotion creams oroilsneartheinfusionsite these productsmayloosentheadhesive Theadhesiveisdesignedforone timeuse Once removed aPodcannot bereapplied IfyouareapplyingaPodinaplacethatdoesnothave alotoffattytissueorisverylean pinch theskin aroundthePod Figure5 20 afteryoupressStart andholdit untilthecannulainserts Occlusionsmay result inlean areasifyou donotusethis t...

Page 66: ...re 5 17 Figure 5 21 Figure 5 22 Checktheinfusionsiteafterinsertiontoensure thatthecannulawas properlyinserted You shouldcheckyourbloodglucose1 5to2hours aftereachPodchangeandchecktheinfusionsite periodically Ifthecannulaisnotproperly inserted hyperglycemiamayresult Verifythereis nowetnessorscentofinsulin whereasmayindi catethecannulahas dislodged Ifyouobservebloodinthecannula checkyour bloodglucos...

Page 67: ... Press Discard torestart theprocesswitha newPod OrpressBacktoreturntothepreviousscreen CheckPodStatus TocheckPodstatus ifthePDMis turnedOff pressandhold the Powerbuttonto displaytheIDscreen thenpress Confirmto displaytheStatus screen IfthePDMisOn pressBackuntilyou reachtheStatusscreen Ifyoupressandholdthe Powerbut Figure 5 23 NEVER injectinsulin oranything else into the fill port whilethe Pod ison...

Page 68: ...erbuttons to chooseSuspend thenpress Select 2 Enterhow longyouwant tostopallinsulindelivery from30 minutes to2hours in30 minuteincrements Figure5 25 thenpress Enter 3 Press Confirmtoconfirmthatyouwant to halt allinsulin delivery basalandbolus ThePDM beepsandanon screen messageletsyouknowthat insulindeliveryisindeedsus pended Figure5 26 ThePodbeepsevery15minutesuntiltheendofthesuspen sionperiod The...

Page 69: ...ss OK Figure 5 20 Figure 5 25 Figure 5 26 TheAdvisoryalarmrepeatsevery 15minutesuntilyou press OK Insulindeliverywill not resumeuntilyoupressOK If youdonotpress OKtoresumeinsulindelivery you coulddevelophyperglycemia highbloodglucose Figure 5 22 Figure 5 27 ...

Page 70: ...althcareprovider Atleastonceaday usethePod s viewing window to check thesiteforsignsofinfectionandtoconfirmthatthesoftcan nulais securelyinplace Be awareofthesignsofinfection includingpain swelling redness discharge orheat at thesite Ifyoususpectaninfec tion immediatelyremovethePodandapplyanewoneina differentlocation Thencallyourhealthcareprovider ChangethePodasinstructedby yourhealthcareprovider ...

Page 71: ...mbertocheckyourbloodglucoselevelsfrequently beforeand afterremovingthePod Checkwith your healthcareproviderforguidelines onremovingthePod forextendedperiods Insulindegrades at hightemperaturesandwill freezenear32 F 0 C Checktheinsulinmanufac turer sinstructions foruse DonotexposeyourPodto wateratdepthsgreater than25feetorformorethan 60minutes Check oftentomakesurethePodand soft cannulaare securely...

Page 72: ...dthePDM isturnedon thePDM estab lishescommunicationwiththePodtoobtainastatuscheck Duringthestatuscheck thePDMcollectsinformation fromthe Podaboutbolusdeliveries activebasalprograms andPodexpi ration The informationobtainedis thendisplayedinthestatus screen whichshowstheSystem scurrentoperating status TheStatusscreen Figure6 2 displays Time date andresult oflastbloodglucosecheckedor enteredmanually...

Page 73: ... 50 U Oncethereservoirvolumedropsto 50 units the gauge counts down unitbyunit Whenthe volume fallsbelow5units thedisplaychangesto LOW PDMsettings YoucanadjustthePDM settings tomeetyourindividualneeds 1 FromtheStatusscreen press Home 2 UsetheUp DownControllerbuttonstochooseSettings thenpress Select 3 ChooseSystemsetup thenpress Select 4 Chooseanoptionfromthe Systemsetuplist thenpress Select Figure6...

Page 74: ...ngethosesettings as describedinthischapter ResettheDateorTime Occasionally you needtochangedateand timesettings for example toadjustfordaylightsavingstimeorafterresettingthe PDM Asasafetyfeature youcanchangedateandtimesettings onlywhenthePodis deactivatedorwheninsulin deliveryissus pended seeChapter5 UsingthePod 1 Suspendinsulindelivery 2 OntheHomescreen usetheUp DownControllerbuttons tochooseSett...

Page 75: ...rmatto bedisplayedbythePDM then press Select 5 Press Confirmtoaccept thenew dateandformat ChangeBolusandBasalSettings You andyourhealthcareproviderenteredinitialbolusandbasal SystemsettingsusingtheSetupWizard UsingtheSystemsetup menu youcaneditallthemylifeOmniPodSystembolusand basalsettingsasyourneedschange Checkwithyourhealthcare providerbeforemakinganychanges 1 OntheHomescreen usetheUp DownContr...

Page 76: ...Up DownControllerbuttonstochooseastart time endtime targetBGvalue andcorrect abovevalue correctionthreshold PressNextaftereachentry c Whenyou havecompleted all thetimesegmentsyou want pressDone thenSave 2 MinBGforcalcs minimumbloodglucosevalueallowed for calculatingboluses UsetheUp DownControllerbuttons toenteranewminimumBG thenpressNext 3 Insulin to carb IC ratio Youcan editexistingtimeseg mentsa...

Page 77: ...dcorrectionfactor PressNextafter eachentry c Whenyouhavecompletedalltimesegments press Done thenSave 5 Reversecorrection ChooseOnorOff thenpressNext 6 Insulinaction duration UsetheUp DownController buttons tochooseadurationofinsulinaction thenpress Done 7 Press OK Ratios factors targets WhenthesuggestedboluscalculatoristurnedOn youcanview andchangeallthesettingsusing theRatios factors targets menu...

Page 78: ...atiotimesegment choosetheseg ment thenpressEdit UsetheUp DownController but tonstochooseanewstarttime endtime andICratio Press Nextaftereachentry b To addasegment choose addnew thenpress New UsetheUp DownControllerbuttonstochoosea start time endtime and ICratio PressNextaftereachentry c Whenyou havecompletedalltimesegments press Done thenSave 4 Correctionfactor Youcaneditexistingtimesegmentsand ad...

Page 79: ...tions youcan useare BG bloodglucose reminder Remindsyoutocheckyourblood glucose ChoosefromOnorOff ThedefaultsettingisOff When thereminderison thePDMasksyoueachtimeyouenterabolus dosewhetheryouwant to set aBGreminder andyoucanthen chooseatime interval in30 minuteincrements Podexpiration Remindsyou whenthePodisnearingthe72 hourexpirationtime Chooseaperiodfrom1to24hours before expiration in1 hourincr...

Page 80: ...seinclude Temporarybasalinprocess Extended bolusinprocess ChooseOnorOff Thedefaultsetting isOn Confidencereminders ThePod orPDMbeepsinresponseto yourinstructions soyou becomefamiliarwiththeoperationof themylifeOmniPodSystemandfeelconfident thatyou areget tingtheinsulinyou need Thesenotificationsinclude Bolus deliverystarted Bolus deliverycompleted Extendedbolusstarted Extendedboluscompleted Tempor...

Page 81: ...et Figure6 9 thenpress Select 5 Forallexcept Bolusremindersand Customreminders choosethedesiredoptionorsetthedesiredvalue thenpress SelectorEnter 6 For Bolusreminders UsetheUp DownControllerbuttonstochooseOnor Off thenpressSelect IfyouchoseOn youaretakentoanewscreenwhereyou canadd editordeletereminders ToaddaBolusreminder a UsetheUp DownControllerbuttonstochoose add new thenpress New b Choosea sta...

Page 82: ...fyouwanttogiveadifferentnametothereminder a UsetheUp DownControllerbuttonsto scroll throughthelistofcharacters Anup and downarrow symbolonthescreenindicatesthecharacteryouare changing b PressthemiddleSoftKey therightarrow tomovethe underscoretothenextcharacter c Entereachcharacteroneat atime Forexample fora reminderto pickupaprescription youmight enter R x Figure6 10 Ablankcharacterorspaceisthefir...

Page 83: ...eBGmeter thenpressSelect 4 Choosethesettingyouwant tochange Figure6 11 then press Select ChangeBGgoallimits TochangetheBGgoallimits pressEdit changeeitherorboth values thenpress Save Managethebloodglucosetagslist Youcancreateupto15custombloodglucosetagsandhideany ofthestandardtagsyoudonotplantouse StandardBGtagsare shownfirst onthescreen Figure6 12a followedbycustom tags andthen addnew Figure6 12b...

Page 84: ...betesManager Additionaloptionslet youcustomizehowthePDMoperates IDscreen IdentifyyourPDMbyaddingyournameandchoosing acolor TheoptionsyousetwillbeshownontheIDscreenevery timeyou turnonthePDM PDMlock Locks thebuttonsonthePDM Thedefaultsettingis Off Thissafetyfeaturecanhelpavoidaccidentallychanging basalrates orgivingboluses Screentime out Thescreenturnsoff afteratimeintervalthat youset whichoccursif...

Page 85: ...elect 2 Press theUp DownControllerbuttonsto scrollthroughthe list ofcharacters Anup and downarrow symbolonthe screenindicatesthecharacteryou arechanging 3 Press themiddleSoftKey labeledwiththeright arrow to movetheunderscoretothenext character 4 Entereachcharacteroneatatime Forexample ifyou want toenteryourname youmightenterJ a n e space S m i t h Ablankcharacterorspaceis thefirstandlastoptioninth...

Page 86: ...roperlywhen needed Whenyouselectthisfunction thePDMbeepsand vibrates thenthePodbeeps Thisfunctioncannotbeexecuted unlessinsulindeliveryis suspended ResetPDM softreset Restores allsettingsinthePDM to the factorydefaults Ifyou chooseOn otherPDMoptions andmost othersoftkeysarelockedandwillnot respondto buttonpresses To usethem you mustfirstsetPDM locktoOff Thelowestsettingwilldrainthebatterytheleast ...

Page 87: ...e itthenbeepsthreetimes ToresetthePDM 1 ChooseResetPDM thenpress Select 2 IfthePod isdeactivated thePDMasksforconfirmationand remindsyouthatyouwillloseallusersettings Figure6 15 Press Confirmtoreset thePDM IfthePod isstillactive you willbeunabletoresetthePDM Figure6 16 Press OKtoreturn totheDiagnosticsmenu Besuretocheckthealarmfunctionat everyPod change Usetheform at theendofthisUserGuidetowrite d...

Page 88: ...rntothe Settingsmenu GettheMostfromYourPDM Keepithandy Wireless communicationtechnologymeansyou don thaveto keepthePDMrightnexttothePodforthePodtowork Once yousetyourbasalprogram thePodcontinues todeliveryour basalprogram24hours aday regardless ofthelocationofthe PDM However youstillneedthePDMtodeliverabolus change thebasalrate andsoon You canstorethePDM conveniently insideanarticleofclothing like...

Page 89: ...up tionsareeasytoresolve seeChapter11 Communication Failures DonotstoreorleavethePDM whereit maybe exposedtoextremetemperatures suchasinsidea car Extremeheatorcoldcancausethedeviceto malfunction Neverattempttotestyourbloodglucosewhileyour PDM isconnectedviaUSBcableto acomputer Doingsocouldresultinelectricalshock OnlyconnectaUSBcableto yourPDMwhendown loadingdatatoacomputer OtherPDMfunctionsare dis...

Page 90: ...utodoso KeepthesystemandtheFreeStyle accessoriesaway from young children astheycontainsmallparts that maybedangerousifswallowed OnlyuseFreeStyle test stripsandFreeStyle control solutionwiththeSystem Usingotherbrandsoftest stripsand control solutions withtheSystem canpro duceinaccurateresults Neverattempttotest yourbloodglucosewhileyour PDM isconnectedviaUSBcableto acomputer Doingsocouldresultinele...

Page 91: ...eStyle ControlSolution TheFreeStyle controlsolution Figure7 1 isa redliquidthat containsafixedamountofglu coseandhastwoimportantuses Toensurethat yourmeterandtest strips areworkingtogetherproperly Topracticetestingwithouthavingtouse yourownblood Threelevels ofcontrolsolutionareavailable Low Normal andHigh Forinformationon howtoobtaincontrolsolution call Customer Care CompleteinformationontheFreeSt...

Page 92: ...hichevercomes first Count forward3months fromthedate youopenanewbottleofcontrolsolution Thisis yourdiscard date Writethisdateonthesideofthecontrolsolutionbottle For example ifyouopenthecontrolsolutiononJanuary15 count forward3months to April15 Thisis thediscarddatetorecord onthebottle aswellasthedatetodiscarditand begin usinga new bottle Ensureaccuratecontrolsolutionresults Replacethecapon thecont...

Page 93: ... C Ifyourcontrolsolutiontestresultscontinuetofalloutsidethe rangeprinted on thetest stripvial 1 TheSystemmay notbeworkingproperly 2 DonotusetheSystemtotestyourbloodglucose 3 CallCustomerCare PerformingaControlSolutionTest 1 Graspthebottomoftheteststripwiththeprintedsidefacing up Figure7 2 2 Insertthetopoftheteststripintotheteststripport Figure7 3 onthenextpage untilitstops ThisturnsonthePDManddis ...

Page 94: ...as movedtothenextscreen just presstheUp Down Controllerbuttons Thecodescreenreappearsandyou canadjustthenumber Thecodenumberremains onthePDMscreenforyour referenceuntilyouhavecompletedthecontroltest Figure 7 3 Figure 7 4 FromsomePDMscreens youcannotaccesstheFree style bloodglucosemeter Forexample youcannot usethemeterwhileyouareactivatingaPodorwhen analert alarmorcommunicationerrorscreenisdis play...

Page 95: ...soff Toturnitonagain pressLight The Checking screenappearswhilethesampleisprocess ing Figure7 7 Thestripportlightturnsoffwhenthesample isaccepted IfBGsound issettoOn thePDMbeepstwice Theresult appearsonthescreen 6 To marktheresultasacontrolsolutionresult ratherthana blood glucosetest a Press Tag b UsetheUp DownControllerbuttonstoselectControl Figure7 8 thenpressSelect Youcanselectasecondtag forthe...

Page 96: ... you willstill see theavailablesoft keys PerformingaBloodGlucoseReading Figure7 9 onthenext pageshowsthepartsofthelancing device You canselectamaximum of2tags IfthesuggestedboluscalculatorfeatureisturnedOff theBolussoftkeyappearsinsteadof Next Ifyoumarkatestasacontrolsolutiontestbymistake youcanunmarkit PressTag selectControl then press Clear Besuretodiscardusedteststrips Youcanonlyuse teststripso...

Page 97: ...elancetfirmlyinplacewithonehand Withyourother hand twistofftheroundedtop Figure7 12on thenext page Release button Depth indicator window Depth settings dial Gray cap for testing on the fingers Cocking handle Figure 7 9 Clear cap for testing sites other than the finger Figure 7 10 Figure 7 11 Lancing device depicted in Figures 7 9 7 10 and 7 11 is representative only Please follow the instructions ...

Page 98: ... arenow readyto performa blood glucosetest Insertthebloodglucoseteststrip 1 Insertanew bloodglucoseteststripintotheteststripport untilit stops Theteststrip port isatthebottom ofthePDM Consultyourlancingdeviceinstructions to ensure properusage Figure 7 12 Figure 7 13 Figure 7 14 Figure 7 15 Lancing device depicted in Figures 7 12 7 13 7 14 and 7 15 is representative only Please follow the instructi...

Page 99: ...rmust matchthecodeonthesideof thevial FromsomePDMscreens youcannotaccesstheFree Style bloodglucosemeter Forexample you cannot usethemeterwhileyouareactivatingaPodorwhen analert alarmorcommunicationerrorscreenisdis played Inthesecases ifyou insert ateststrip the PDM beepstoalertyou Figure 7 16 Top Bottom Figure 7 17 Ifyou donotstart thetest within2minutes thePDM powersoff TorestartthePDM takeoutthe...

Page 100: ...ecap againstthe sideofyourfingertip Figure7 21 4 Press thereleasebutton Ifyou needtoadjustthecodenumberafterthePDM has movedtothenextscreen just presstheUp Down Controllerbuttons Thecodescreenreappearsandyou canadjustthenumber Thecodenumberremains onthePDMscreenforyour referenceuntilyouhavecompletedtheBGtest Figure 7 19 Thecodenumberonthescreenshouldmatchthe codenumberonthe sideofyourteststripvial...

Page 101: ... Donot liftup continueto holdthe buttonandgraduallyincreasepressureagainst thesitefor severalseconds Figure7 24 5 Whileholdingthelancingdeviceonyourtestsite look throughtheclearcap Thebloodsampleshouldbeaboutthe sizeofapinhead 6 Liftthelancingdevicestraightup becarefulnottosmearthe bloodsampleonyourtestsite Figure 7 22 Figure 7 23 Measurementsobtainedfromalternatesitetesting should not beusedto ca...

Page 102: ...ePDM Refertopage55tocheckPodsta tusand toConfirmID 2 Bringthestrip tothebloodsampleataslightangle Figure7 26 Ifyou donotapplythesamplewithin10seconds thestrip portlightturnsoff To turnitonagain press Light Useonlyoneedgeofthebloodglucoseteststrippertest Do notapply bloodtobothedges Figure7 27 Onlyusestrips once Discard usedstrips Thetest strippullsthebloodintothestripthroughtheedge Figure7 28 Avoi...

Page 103: ...re 7 28 Thelancingdeviceisintendedforindividualuseand shouldnotbeshared Ifthedeviceisbeingoperated by asecondpersonwhois providingtesting assis tanceto theuser themeterandlancingdevice shouldbedecontaminatedpriortousebythesec ondperson seepage138 Donot Press thestripagainst thetestsite Scrapethebloodontothestrip Applybloodtothe flatsideofthestrip Applybloodtothestripwhenitisoutofthemeter Put blood...

Page 104: ...sultasapre orpost mealtest toindicatea levelofexerciseortoindicateothersituationsconnectedto thisbloodglucosereading press Tag Then a UsetheUp DownControllerbuttons toselecta tag thenpress Select Figure7 31 Youcanselectasecond tagforthereadinginthesameway Tolearnhowtomanageyourlist oftags andto add customtags see Managethebloodglucosetags list in Chapter6 Using thePersonalDiabetesManager b Press O...

Page 105: ...r Instead Press Bolusto openascreenwhereyou canenterabolus manually OrpressDonetoreturnto theStatusscreento seethemost recent BGresult TheBG result eitherfromthePDMorfrom manualentry is stored intheSystem s history whethersuggestedbolus calcula toristurnedOn orOff See Blood GlucoseRecords inChapter 8 UnderstandingYourRecords See Cleaninganddisinfecting intheAppendixfor instructionsonhowtocleanordi...

Page 106: ...CanceltoreturntotheMoreactionsmenuwithout savingthereading EditingTags Within2hoursofabloodglucosereading youcanremoveor changeatagoraddone However youcannotalteraControltag 1 OntheHome screen usetheUp DownControllerbuttons tochooseMoreactions thenpress Select 2 ChooseAssign EditBGtags thenpressSelect TheBolusEntryscreendoesnotopenif Aregularbolusis currentlyinprocess Themetertemperatureis outofra...

Page 107: ...n appearsnexttoselectedtags asin Pre meal inthefigure You canselectupto twotagsforeachBGreading 5 Toremoveaselectedtag highlight itandpressClear The soft keychangesfromSelecttoClearwhenyou highlight thetag 6 Press OKtoreturnto thelistofreadings 7 IfnoBGreadingshavebeenenteredintothePDMwithinthe past2hours youwill seethescreeninFigure7 36 Press OK to returntotheMoreactionsmenu Tolearnhowtomanageyou...

Page 108: ... reading performacontrolsolutiontestto ensureyoursystemis working properly Ifthesystemisworkingproperly follow yourhealth careprovider srecommendationtotreat hypoglycemia Highreadings Ifyourreadingisabove27 8mmol L thePDM displays HIGH Checkforketones Thisindicatesseverehyperglycemia high bloodglucose Highreadingwithsymptoms Ifyougeta HIGHCheckforketones readingandfeelsymp tomssuchasfatigue thirst...

Page 109: ...upperarm andhand You maysee differencesinbloodglucosemeasurementsbetweenthe othertest sites and yourfingeraftereating takinginsulin medication orexercise You mayseechanges inblood glucoseinblood samples from thefingersoonerthaninbloodsamplesfromthefore armandotheralternatesites Vigorousrubbingofthealter natetestsites beforelancinghelpsto minimizethese differences Donotuseduringxylose absorptiontes...

Page 110: ... risk Do NOT removetheoldbatteriesuntilyouhave newonesonhand ThePDMprotectsdatainthe memoryforupto2hoursafterthebatteriesrunout orareremoved Recordswithaquestion marksymbolnextto themhave additionalinformationavailable Toseethisinformation use theUp DownControllerbuttonstohighlighttherecord thenpress theUserInfo Supportbuttontoviewdetails aboutthatrecord Therecordforthis item hasbeen lost IfthePDM...

Page 111: ...sedelivered Figure8 2 Pressthe Up DownControllerbuttons toviewthesummaryfor previousdays Whereveryouseethe symbol presstheUserInfo Support buttontoseeadditionalinformation 3 Toreviewyourbasalhistorybyday press Basal Thedisplayshowsthebasaldeliveries thathaveoccurredfor thecurrent day mostrecentfirst Figure8 3onthenext page Theactivebasalrateorprogram isindicatedbyadia mondicon Therecordforthis ite...

Page 112: ...twasinterruptedduetoaPodalarm Poddeacti vation orusercancellation Thescreenshowstheamount of thebolusorbasalthatremainedundelivered 4 Press Daytoreturn todates 5 Toreview yourbolus historyby day pressBolus Thedisplayindicates whetherthebolus was normalor extended marked e inFigure8 4 Normalandextended bolusesaredisplayedseparately eveniftheywerepro grammedatthesametime Extendedbolusesareshown with...

Page 113: ...ess Select 2 ChooseBGhistory thenpress Select ThePDM displays thecurrent daytrendsfirst Figure8 5 including Numberofdays andnumberofbloodglucose readings n Averagebloodglucose AvgBG Lowestandhighest bloodglucose Min max TheBGgoalyou haveset PercentageofreadingswithintheBGgoal PercentageofreadingsabovetheBGgoal PercentageofreadingsbelowtheBGgoal 3 Press Listtoseealist of thecurrentday sreadings Fig...

Page 114: ...multiple daytrends 1 OntheHomescreen usetheUp DownControllerbuttons tochooseMyrecords thenpressSelect 2 ChooseBGhistory thenpressSelect 3 Press Trendstodisplaybloodglucosedataforthepast7 days 4 Continuepressingthemiddlesoftkeyto view trends forthe previous 14 30 60and90days 5 ThePDM displaysthesamedetailsformultipledaysasfor singledays plustheaveragenumberofBGmeasurements takenperday Figure8 10 Fo...

Page 115: ...to seeadditional screens 4 Chooseanalarm record thenpress UserInfo Supportto seemoreinformation CarbohydrateRecords ThePDM displays therecords ofcarbohydratesyou have entered 1 OntheHomescreen usetheUp DownControllerbuttons to chooseMyrecords thenpress Select 2 ChooseCarbhistory thenpress Select ThePDM displays thedate timeandgramsofcarbohydrate youhaveentered Figure8 13onthefollowing page 3 Press...

Page 116: ...he Up DownController fordates UserInformation Support You oryourhealthcareprovidermayhaveenteredpersonal contact informationduringyourstart upvisit Toviewthisinfor mation presstheUserInfo Supportbutton totheright ofthe Powerbutton whileonthe Homescreen Orfollow thesteps below toview theinformation Youcanaddorchangetheuser informationatanytime Youmaywanttoincludeyourname address phone e mail addres...

Page 117: ... M a i n space S t period Ablankcharacterorspaceisthefirst andlast optioninthescrollingmenu Foryourhealthcareproviderandlocalphonenumber you mightenterJ a n e space S m i t h comma space 5 5 5 hyphen 1 2 3 4 Figure8 16 7 Press Save 8 Repeatsteps 3 7foreachlineofpersonalinformationyou wanttoenterorchange Twentylinesareavailable TheUserInfo Supporticonisalsodisplayedon thesuggestedbolusscreen Forinf...

Page 118: ...elevelsfrequently Washing yourhands anddisinfecting infusionsitestoreduce thepossibilityofinfection Beingawareofthesigns ofhypoglycemia lowbloodglu cose hyperglycemia highbloodglucose and diabeticketo acidosis DKA See AvoidLows HighsandDKA laterinthis chapter Keeping adiabetesemergency kitwithyouatalltimes See PrepareforEmergencies laterinthis chapter Knowinghow to contactyourhealthcareproviderinc...

Page 119: ... s viewingwindow toinspectthe infusionsite Checkthesiteforsignsofinfection suchaspain swelling redness dischargeorheat Ifaninfusionsiteshowssignsofinfection 1 ImmediatelyremovethePodandapply anew oneatadifferentsite seeChapter5 UsingthePod 2 Contactyourhealthcareprovider Treattheinfectionaccordingto instructions from yourhealthcareprovider Referto Chapter5 Using thePod forhow to prepareandcarefora...

Page 120: ...dlancets Glucosetabletsoranotherfast actingsourceof carbohydrate Alcoholprepswabs Acopy oftheletterfromyourhealthcarepro viderforairlinesecurity see Minimizeairport securitydelays laterin this chapter Phonenumbers foryourhealthcareprovider and ordoctorincaseofanemergency Glucagonkitandwritteninstructionsforgiving an injectionifyou areunconscious see Avoid Lows HighsandDKA laterinthischapter Askyou...

Page 121: ...p plusabackupsupply ExtranewPDMbatteriesanddonotuserechargeablebatter ies Additionalbloodglucosemeter Insulinsyringesorpensincaseyouneedinjections Severalvialsofinsulinorinsulincartridgesifyou useapen Glucagonkit Makesureany personyouaretravelingwith knowshowtogivetheinjection Alcoholprepswabs Writtenprescriptions forallmedicationsandsupplies Genericmedicationsmaybeeasierto findthanbrand names Min...

Page 122: ...ning Ifyou reconcernedoruncomfortableaboutgoingthroughthe walk throughmetaldetector you shouldnotifytheSecurityOffi certhatyou rewearingapumpandwouldlikeafull bodypat downandavisualinspectionofyourpumpinstead Youshould alsoadvisetheSecurityOfficerthattheinsulinpumpcannot be removedbecauseitis insertedwithacatheter needle under theskin Visitthecountries provincialairportswebsiteifyouhave anyfurther...

Page 123: ...er Tellyourhealthcareproviderifyouhaveextremehighsor lows orifhighsorlowsareoccurring moreoftenthanusual IfyouhavetechnicalproblemswithyourmylifeOmniPod Systemandcannotresolvethem donothesitateto callCus tomerCare Hypoglycemia LowBloodGlucose HypoglycemiacanoccurevenwhenaPodisworkingproperly Neverignorethesignsoflowbloodglucose no matterhow mild Ifleftuntreated severehypoglycemiacancause seizures ...

Page 124: ...emia lowbloodglucose Anytimeyourbloodglucoseislow treatimmediately Checkit every15minuteswhileyou aretreating tomakesureyoudon t overtreat theconditionandcausebloodglucoselevelstorise toohigh Hypoglycemiaunawarenessis aconditioninwhich you donotrealizewhenyourbloodglucoselevelis low Ifyouarepronetohypoglycemiaunawareness you maywant tousethe mylifeOmniPodSystem s bloodglucosereminderandcheckyourbl...

Page 125: ...Three5 gramglucosetablets orfour4 gram tablets 4ounces 118milliliters ofappleororangejuice 6Lifesavers orsimilarhardcandy 1 2canofregular non diet soda 2tablespoons 30milliliters oftablesugar honeyorcornsyrup Evenifyoucannotcheckyourbloodglucose doNOT wait to treatsymptomsofhypoglycemia especially ifyouare alone Waiting totreat symptomscould leadtoseverehypoglycemia whichcanquicklylead toshock com...

Page 126: ...dtiming DoNOTovercorrectforpost meal glucoselevels Checkcarbintake Consulthealthcareproviderfor guidance Bolustoolarge Possiblecauseoflow Suggestedaction Incorrecttarget bloodglucoselevels Consulthealthcareproviderabout refiningthesesettingsasneeded Incorrectcorrection factor sensitivity factor Incorrectinsulin to carbratio IC Pronetoseverehypo glycemia Consulthealthcareproviderabout hypoglycemiau...

Page 127: ...yandtreatas necessary Consultyourhealthcareprovider aboutadjustingyourbasalpro gramsorusingatemporary temp basalrate Lowcarbohydrate intakepriorto activity Consumecarbohydratebefore activity especiallyifyou havenot decreasedinsulinbeforehand Alcoholconsumption Checkbloodglucosebeforegoing to bed Consulthealthcareproviderfor guidance Effects ofexercisecanlast severalhours evenafull day afteractivit...

Page 128: ...etonesarepresent follow yourhealthcare provider sguidelines 3 Ifketones arenotpresent takeacorrectionbolusaspre scribedby yourhealthcareprovider 4 Checkbloodglucoseagainafter2hours 5 Ifbloodglucoselevelshavenotdecreased takeasecond bolusbyinjection usingasterilesyringe Askyourhealthcare providerwhetherto injectthesameamountofinsulinasin step3 6 Ifyoufeelnauseatedat anypoint checkforketonesandcall ...

Page 129: ...ider Dislodgedcannula DeactivateandremoveusedPod ApplyanewPodinadifferent location Avoid sitesnearawaistband belt orotherareas wherefric tionmaydislodgethecannula Possiblecauseofhigh Suggestedaction EmptyPod DeactivateandremoveusedPod ApplyanewPodinadifferent location Incorrectbasal program Confirm thatcorrectbasalprogram isactive Confirm thatPDM timeisset correctly Consultyourhealthcareprovider a...

Page 130: ...h ketonespresent beforeexercise DoNOTexercisewhenketones are present Bloodglucoseincreases withexercisewhenketones are present Consulthealthcareproviderfor guidance Infectionorillness See Sickdays laterinthis chapter Consultyourhealthcareprovider aboutsickdayguidelines and aboutmedicationchanges Medicationchange Possiblecauseofhigh Suggestedaction Weightlossorgain Consultyourhealthcareprovider for...

Page 131: ...void DKAisbychecking yourbloodglucoseatleast4 6timesaday Routinechecks allowyouto identifyandtreat highbloodglucosebeforeDKA develops TotreatDKA Onceyouhavebeguntreatment forhigh blood glucose checkforketones Checkforketonesanytimeyourblood glucoseis13 9 mmol L orabove Ifketones arenegativeortrace continuetreatingforhigh bloodglucose Ifketones arepresent andyouarefeelingnauseatedorill immediatelyc...

Page 132: ...recordsofresults Checkforketones whenbloodglucoseis13 9 mmol L or higher Followyourhealthcareprovider sguidelinesfortakingaddi tionalinsulinonsickdays Drinkplentyofnoncaffeinatedfluidstoprevent dehydration Callyourhealthcareproviderimmediatelyifyou have Persistent nausea Vomitingformorethan2hours Highbloodglucoseorketones thatstayhigheven though youtakeextrainsulin Lowbloodglucosewithnauseaandvomi...

Page 133: ...tments Remembertoreplacethebasalinsulinthatwasmissedwhilethe Podwas removed Yourhealthcareprovidercanhelpyoupre pareforthesesituations Ifpossible avoidwastingPodsbyplanningremoval timesthat coincidewitha scheduledPodreplace ment ThePodandPDM maybeaffectedbystrong radia tionormagneticfields BeforehavinganX ray MRI or CT scan orany similartestorprocedure remove yourPodandputitandthePDM outsidethetre...

Page 134: ...reofaseriousorpotentiallyseriouscondition theSys temsoundsanalarmanddisplaysanon screenmessage The messagehasinstructionsfortakingcareofthealarm condition Alarmconditionsareeasytohandle They arenotaproblemif youattendtothempromptly BloodGlucoseMeterAlerts Thesealertsletyou knowaboutan errorinthebloodglucose meter teststrip sample orresults ThePDM beepsanddisplays anerrormessagenumber asinFigure10 ...

Page 135: ...of theteststrip vial retestusingbloodanda newtest strip 3 Ifthecontrolsolutiontestdoesnot work ortheerrorpersists call CustomerCare MeterError2 Seeusermanualfor furtherinstructions Problemwiththeteststrip Problemwiththemeter Veryhighbloodglucose above27 8mmol L HIGHcontrolsolution appliedwhentemperature istoocold Thisapplies onlytocontrolsolution labeledHIGH 1 Ifyou havesymptoms suchasthirst fatig...

Page 136: ...ingbloodanda newteststrip 3 Ifthecontrolsolutiontestdoesnot workortheerrorpersists call CustomerCare MeterError4 Seeusermanualfor furtherinstructions Problemwiththeteststrip Problemwiththemeter 1 Conducta control solutiontestusinga newtest strip Iftheresults of thecontrol solutiontestarewithintherangeprintedonthesideof theteststrip vial retestusingbloodanda newteststrip 2 Ifthecontrolsolutiontestd...

Page 137: ...ensitive andrequirearesponse Someadvisoryalarmsescalatetohazard alarms ifyoudo not respondwithin acertain timeperiod as notedinthefollowingtable Someadvisoryalarmsarecontrolledbylevels yousetinthe Settingsscreen OneexampleisthelevelatwhichtheLow reservoirvolumealarm sounds HazardAlarms HazardalarmsoccureitherwhenthePodisinavery seriouscon ditionorsomethingiswrong withthePDM Hazardalarms are contin...

Page 138: ...Advisory Alarm Pod and PDM 2setsofbeepseveryminutefor3 minutes Repeatsevery15minutesuntil insulindeliveryisresumed Press OKtoresumeinsulindeliveryat programmedbasalrate Auto offalert Advisory Alarm Pod and PDM 2setsofbeepseveryminutefor15 minutes Escalatesto Auto offhazardalarm ifnot acknowledgedwithin15 minutes Press OKtoacknowledge Insulindelivery willnotresume untilyoupressOK Ifyoudonot pressOK...

Page 139: ...severyminutefor3 minutes Repeatsevery60minutesuntil acknowledged Escalatesto Emptyreservoir hazardalarmwhenempty Press OKtoacknowledge Emptyreservoir Insulindeliverystopped ChangePodnow Hazard Alarm Pod and PDM Continuous tone This alarmoccurs whenthePod s reservoiris outofinsulin PressOKto acknowledge ChangePod Checkbloodglucose Alarm Type Source BeepPattern Action TheLowreservoiralertwill escala...

Page 140: ...ge ChangePod SeeChapter5 Usingthe Pod Podexpired Insulindeliverystopped ChangePodnow Hazard Alarm Pod Continuous tone This alarmoccurs whenthePodhas reachedtheendofitsoperatinglife Press OKtoacknowledge ChangePod Checkbloodglucose Stuckkeydetected CheckHome buttonto resolve Fortechnicalsupportrefer to yourUserGuide Advisory Alarm PDM 2setsofbeepsevery5minutes Checkthekeydescribedonthescreen Inthis...

Page 141: ...odnow Hazard Alarm Pod Continuous tone ThisalarmoccurswhenthePoddetects anunexpectederror PressOKto acknowledge ChangePod Checkbloodglucose PDMError RemovePodnow For customer support refer to your User Guide Hazard Alarm PDM Continuous tone Thisalarmoccursifanunexpectederror isdetectedin thePDM PressOKto acknowledge RemovePod CallCustomerCareimmediately Checkbloodglucose Alarm Type Source BeepPatt...

Page 142: ...se SystemError Removepodnow For customer support refer to your User Guide Hazard Alarm Pod or PDM Continuous tone Thisalarmoccursifanunexpectederror isdetectedinthePodorPDM PressOK to acknowledge RemovePod CallCustomerCareimmediately Checkbloodglucose PDMError Press OKtoreset clock Hazard Alarm PDM Continuous tone This alarmoccurs afterthePDM isreset indicatingthatthetimeanddatemust bereset Press ...

Page 143: ...hefillport 3 Pressthepaperclipstraightdownintothemanualalarmshut offportuntilthealarmstops andcannolongerbeheard ThendiscardthePodaccording tolocalwastedisposal regu lations 4 HardResetportislocatedinthePDM sbatterycompartment Figure10 3 The HardReset allowstheusertoresetthe PDM i e ifthescreenlocks upandgoesintoanalarm The usersPDM settings arenotlost Poddeactivationrequired Press Ok todeactivate...

Page 144: ...youtsideinterference Seethe mylifeOmni PodSystemNoticeConcerning Interference intheAppen dix FailureDuringPodActivationorOperation WhenyousendaninstructionfromthePDM suchasStartto beginbolusdeliveryorEnabletobeginusingadifferentbasal program thePodusuallyresponds quickly However ifthe PDM cannotsendyourinstructionwithina fewseconds it dis playsthe Communicationerror screen Figure11 1onthenext page...

Page 145: ...withthePodagain Ifitcannot communi cate it displays thesamescreenasinFigure11 2 then finallythe Communicationtime out screen Figure11 3 PressOKto checkthePodstatus b Ifthestatuscheckfails youwillseethescreeninFigure 11 4 PressOKtotry checkingPodstatusagainorpress Discardtobeginthedeactivationprocess Figure 11 1 Figure 11 2 Figure 11 3 Figure 11 4 ...

Page 146: ...ouwereactivatingaPod theSystemreturnstothepre viousscreenwhereyou cancontinueactivation Ifyou wereissuinganyothercommand theSystemreturnsto theStatusscreen whereyoucanreissuethecommand FailureDuringPodDeactivation Toreviewthedeactivationprocess see Deactivatethecurrent Pod inChapter5 UsingthePod Ifyou pressConfirmtodeactivatetheactivePodandthePDM cannotsendyourinstructiontothePod youwillseethescre...

Page 147: ...is asoft keylabeled Skip Either 1 Wait untilyouseethe Pod statusnotavailable screen Figure11 10 Or 2 Press Skiptoskipthecommunicationprocess andimmedi atelybringup Figure11 10 Ifyou haveanunconfirmedcorrectionboluswhenyou discard aPod thentheboluscalculatorwillbetemporar ily disabled Inthissituation thebolus calculatoris dis ableduntil theduration of insulin actionperiod passes Figure11 8 Ifyouhav...

Page 148: ...DMto cancelabolus ifthePDM cannot sendyourinstructiontothePodwithinafewseconds itdisplays the Communicationerror screen Figure11 12 1 MovethePDMclosetothePod ThePDM triestocommuni catewiththePodagain 2 IfthePDM stillcannotcommunicatewiththePod you will seethe Bolusstatusunknown message Figure11 13 IfthePod hasexpired youwillseethescreenin Figure11 11instead Figure 11 11 Figure 11 12 Figure 11 13 ...

Page 149: ...beginthedeactivation process 4 IfatanypointinthisprocessthePDM cancommunicate againwiththePod you willseeFigure11 15 Themessage indicatesthat youroriginalinstructiontocancelthebolus was successful a Press OK ThePDM displaysthescreeninFigure11 16 showinghowmuchinsulinwasdeliveredbeforethe bolus was canceled b Press OKagaintoreturntotheStatusscreen IfyourPDMis damagedornotworkingas expected callCust...

Page 150: ...apand water However donotusestrongdetergents orsolvents They candamagethePod scasing orirritatethe infusionsite PersonalDiabetesManagerCareand Maintenance Storage WhenyouarenotactivelyusingthePersonalDiabetesManager PDM toenterorchangeprograms youcanstoreitina conve nient nearbylocation Thestoragelocationshouldbecooland dry IfthePDM isnotsafefromchildrenorotherswhomaypressthe buttons byaccident co...

Page 151: ...aningordisinfecting 2 TocleananddisinfecttheoutsidesurfacesofthePDM hous ing useDispatch Hospital CleanerDisinfectantTowelswith Bleach EPAReg No 56392 8 availableonlinethrough majorretailers 3 Followingtheinstructions onthelabeloftheDispatch Hos pital CleanerDisinfectantTowelswithBleach EPAReg No 56392 8 wipetheoutsidesurfacesofyourPDM Treatedsur facesmustremainwetforafull 1 minute 4 Let yourPDM a...

Page 152: ...cons ThePDM automaticallyalertsyou whenits batterypowergets low seeFigureA 2 Whenyou seethe Low PDMbattery alert press OKtoturnoffthealert Replacethebatteries assoonas youcan AAAalkalinebatteriesarethepreferredbatteryto powerthePDM Donotuseanyothertypeofbatter ies Neveruseoldorusedbatteries thePDM may not workproperly Using anykindofbatteries other thanalkalinemayreducebatterylifeandcausedam ageto...

Page 153: ...vethebatteries and discardthem 3 Usea clean lint freeclothtogentlyabsorbanywaterinthe batterycompartment 4 Leavethebatterycompartment dooropenuntilthePDMis thoroughlydry 5 Donotputinfreshbatteries orattemptto usethePDMuntil it hasthoroughlyair dried WhenyourPDMalertsyouthatbatterypowerisgetting low thePDM willmaximizeremaining batterylifeby Turningoffyourvibrationalert ifset Disablingbrightmode Di...

Page 154: ...OmniPodSystemproductsandsupplies call CustomerCare IfyourPDMisdamagedornotworkingasitshould pleasecallCustomerCareforassistance Besureto checkyourbloodglucosefrequently Removeyour Podandcontactyourhealthcareproviderfortreat mentguidelinesto follow afteryouremoveit Ifyou requireassistance pleasecallCustomerCare StoreallmylifeOmniPodSystemproductsandsup plies includingunopenedPods inacool dryplace P...

Page 155: ... L 1 4mmol L 50CF 0 5units reversecorrection bolus reducesmealbolus Mealboluscalculation Carbsentered insulin to carb IC ratio Exampleofmealbolus Carbsentered 45gramsofcarb Insulin to carbratio 15 45carbs 15I Cratio 3unitsmealbolus Insulin on board IOB calculation Durationofinsulinaction timesinceyourprevious bolus durationofinsulin action previousbolus IOBfrom apreviouscorrectionbolusiscalled cor...

Page 156: ...ctor CF 50 Durationofinsulinaction 3hrs Example1 CurrentBG level 8 4mmol L Carbintake 0gramsofcarbohydrate carbs Meal IOB 1units Correctioninsulinonboard IOB 1units Correctionbolus 8 4mmol L current 5 6mmol L target 50 50 50 CF 1unit Mealbolus 0 carbs 15 ICratio 0units Suggestedbolusdose 1 correction 0 meal 2 IOB 0U Example2 CurrentBG level 8 4mmol L Carbintake 45carbs Meal IOB 0units CorrectionIO...

Page 157: ...doses Suggested bolusdosesareroundeddownto thenearest 0 05U Ifthetotalofthesuggestedboluscalculation correction bolus plusmealbolus islessthanzero thesuggested bolus doseis 0 00U TheSystemwill not suggest abolus doseifyourcurrent bloodglucose BG readingisbelowtheminimumBGyou havesetforbolus calculation seeChapter2 GettingStarted andChapter6 UsingthePersonalDiabetesManager TheSystemsuggestsa correc...

Page 158: ...cose valueandyouhavesetreversecorrection toOn thesug gestedcorrectionbolusis subtractedfrom thesuggested mealbolus Ifyou havesetreversecorrectionto Off the Systemwillnotsubtractinsulinfromthesuggested meal bolus dose Ifyoumanuallyincreaseordecreasethesuggestedbolus the following rulesapply Ifyou increaseasuggestedbolus theincreaseisappliedto themeal bolus unless thereisnomealbolus inwhichcaseit is...

Page 159: ...ements DefaultisOff Bloodglucosemetersound OnorOff Defaultis On Suggestedboluscalculator OnorOff Defaultis On TargetBGvalueand correctionthreshold 8timesegments 3 9to 11 1 mmol Lin0 1mmol Lincrements MinimumBGallowedfor usebythesuggestedbolus calculator 2 8to3 9mmol Lin0 1mmol L increments Defaultis 3 9mmol L Insulin to carb IC ratio 8timesegments 1to150g carb Uin1gcarb Uincrements Correction sens...

Page 160: ...nge 20 85 noncondensing Operatingatmosphericpressure 696hPAto 1060hPA Storageatmosphericpressure 696hPAto 1060hPA Non pyrogenic Fluidpathwayonly TypeBF Medicaldevice protectionfromelectricalshock FlowCapability Basal Programmablebytheuserin0 05Upulses upto30 0Uperhour Bolus Rate 1 5unitsperminute Range 0 05to30 0units Deliveryaccuracy testedperIEC60601 2 24 Basal 5 atrates 0 1U hr Bolus 5 forallse...

Page 161: ...ngesintheflowrateoverthe stabilizationperiod Themeasurements weremadeusingaPod withabasalrateof0 05U hat highoperatingtemperature Flowrateerror Thefollowingtrumpetcurveshows theaccuracyofthedelivery rateinrelationto theobservationperiod Themeasurements weremadeusingaPodwithabasalrateof0 05U hathighoper ating temperature Theoverallmeanpercentageflowerrorwas 1 40 ...

Page 162: ...ange 10 to90 non condensing Operatingatmosphericpressure 696hPAto 1062hPA Storageatmosphericpressure 703hPAto 1062hPA Communicationdistance AtstartupthePDM and pod should be adjacent and touching either in or out of tray to ensure propercommunicationduringpriming Atleast60 152 40cm during normaloperation Alarmtype Audible Alerttype Audibleandvibratory Warranty 4YearLimited PDM BloodGlucoseMeterSpe...

Page 163: ...rialnumber TypeBFmedicaldevice protectionfromelectricalshock Manufacturer Non pyrogenic fluidpathwayonly NotMRI safe Waterproofto25feetforup to60minutes Keepdry Symbol Meaning Storagetemperature Donotuseifpackageis damaged AuthorizedRepresentativeintheEuropean Community Productisdesignedandmanufacturedinaccor dancewithapplicablestandards guidelinesand maybesoldintheEU EuropeanUnion Donotthrow away...

Page 164: ...DA Icon Meaning Icon Meaning Power Moreactions Bolus Communication Podchange Up Down Diagnostics settings Up Down oncolor Tempbasal Status Suspend cancel Text entryright MyRecords Submenu Advisoryalarm Homescreen Alternating Hazardalarm Insulingauge Alert Applybloodsample Bloodglucoserecords PDMlock SetupWizard Battery3 4full Batteryfull Battery1 4full Batteryhalffull Basalprogram Batteryempty Los...

Page 165: ...mis incompliancewiththeessentialrequirementsandotherrele vant provisionsofDirective1999 5 EC ThisISMdevicecomplies withCanadianICES 003andIC RSS 210 ElectromagneticCompatibility Theinformationcontainedinthissection such asseparation distances is ingeneral specificallywrittenwithregardtothe mylifeOmniPodSystem Thenumbersprovidedwillnotguaran teefaultlessoperationbut shouldprovidereasonableassurance...

Page 166: ...is intendedforuseintheelectromagneticenvironmentspecifiedbelow Theuserofthisequipment shouldassure thatisusedinsuchanenvironment Emissions Complianceaccordingto Electromagneticenvironment RFEmissions CISPR11 Group2 ThePodandthePDM emitlowlevelelectromagneticenergy RF in orderto communicate Althoughunlikely nearbyelectronicequip mentmaybeaffected CISPRB EmissionsClassification ClassB TheSystemissui...

Page 167: ...ance d 1 17 P d 0 35 P80MHz to800MHz d 0 7 P800MHzto2 5GHz whereP isthemaximumoutput powerratingof thetransmit terinwatts W accordingtothetransmittermanufacturerand distherecommendedseparationdistanceinmeters m FieldstrengthsfromfixedRFtransmitters asdeterminedbyan electromagneticsitesurvey a shouldbelessthanthecompli ancelevelineachfrequencyrange Interferencemayoccurinthevicinityofequipmentmarked...

Page 168: ...rencebymaintainingaminimumdistancebetweenportableandmobileRFcommuni cationsequipment transmitters andtheSystem asrecommendedbelow accordingto themaximumoutputpowerofthecom munications equipment Ratedmaximumoutputpower oftransmitter inwatts Separationdistanceaccordingtofrequencyoftransmitter inmeters 150kHzto80MHz d 1 17 P 80MHzto800MHz d 0 35 P 800MHzto2 5GHz d 0 7 P 0 01 0 12 0 035 0 070 0 1 0 37...

Page 169: ...hr Basalsegment timesegment Thetimeperiodduring whichaspecificbasalrate isdelivered BGgoal Arangeofbloodglucoselevelsthatyouaretryingtoachievedur ingacertainperiodoftheday Forexample youmaywantone BGgoalbeforemeals adifferentBGgoaltwo hours aftermeals andyetanotherBG goalforbedtime Bloodglucose seeglucose Bloodglucoselevel Theamountofglucose orsugar intheblood Bloodglucosemeter Adeviceusedto check...

Page 170: ...s Harmfuleffectsofdiabetes suchasdamagetotheeyes kidney heart blood vessels nervoussystem teethandgums feet and skin Correctionbolus Anamountofinsulintakentocompensateforhighbloodglucose levels ThemylifeOmniPodSystemcalculatesthecorrection bolus bytakingthedifferencebetweenyourcurrent bloodglu coselevelandyourtargetbloodglucosevalue thendividing the resultbyyourcorrectionfactor Correctionfactor al...

Page 171: ...ependingonthetypeofinsulinyoutake Onlyuserapid acting insulinwiththemylifeOmniPod InsulinManagementSystem Extendedbolus AfeatureofthemylifeOmniPodSystemthat allows amealbolus dose tobegivenoveranextendedperiodof time Fat Oneofthethreemainenergysourcesinfood Theothertwoare carbohydrateandprotein Fatisaconcentratedsourceofenergy providing9caloriespergram Foodshighinfatincludeoils mar garine saladdre...

Page 172: ...healthypancreasmakeinsulin Insulinonboard IOB activeinsulin Theamountofinsulinthatisstill active inthebodyfromaprevi ous bolusdose InthemylifeOmniPodSystem insulinonboard IOB isconsideredintwoparts theInsulinonBoard IOB froma previouscorrectionbolusandtheIOBfromapreviousmealbolus Theamountoftimeinsulinremains onboard or active dependsoneachindividual sdurationofinsulinaction Talkwith yourhealthcar...

Page 173: ...ultipledailyinjections MDIs Introducinginsulinintothebodywitha syringeseveraltimes a day Occlusion Ablockageorinterruptionininsulindelivery Primebolus Anamountofinsulin usedtofillthecannula preparing itto begindeliveringinsulinunderyourskin Protein Oneofthethreemainenergysourcesinfood theothertwoare carbohydrateand fat Proteinisnecessaryforthegrowth main tenance andrepairofbodycellsandtissues Prot...

Page 174: ...cificsettings andinputs Thesettingsused tocalculateasuggestedbolusare targetBG insulin to carbohydrate IC ratio correctionfactor CF anddurationofinsulinaction Theinputsusedtocalculateasug gestedbolusarecurrentBG carbsentered and insulinonboard Thebolus calculatorcanbeturnedOff orOninthePDM Targetbloodglucose BG level Theidealnumberatwhichyouwouldlikeyourbloodglucose levelto be ThemylifeOmniPodSyst...

Page 175: ...7 confidence reminders 67 custom reminders 68 low reservoir alert 15 66 missed bolus 67 Pod expiration reminder 66 program reminders 67 aseptic technique 57 164 automated cannula insertion 3 53 auto off alert 67 B backlight time out 72 set 73 basal history 98 basal program 11 16 22 164 add segment or rate 21 copy 22 create 17 delete 22 edit segment or rate 21 enable 19 rename 22 basal rate 1 11 16...

Page 176: ...39 change 39 create 38 delete 39 enable 38 rename 39 bolus reminder add 68 bolus reminders 67 Bolus basal calcs menu 63 bright mode 5 72 buttons Home Power 5 Up Down Controller 5 User Info Support 5 C calorie 165 cancel bolus 36 bolus preset 39 one time temporary basal rate 24 temporary basal presets 26 cannula 2 165 automated insertion 8 53 carb presets 2 39 41 165 change 40 change category 41 cr...

Page 177: ... correction factor 13 28 64 65 165 correction IOB 141 correction threshold 28 63 65 165 create basal program 17 bolus preset 38 carb presets 39 temporary basal presets 24 CSII See continuoussubcutaneous insulin infusion CT scans 120 custom reminders 68 69 customize PDM 71 D date and time 11 61 dawn phenomenon 165 deactivation See Pod deactivating delete basal program 22 bolus presets 39 bolus remi...

Page 178: ...ilure See communication failure fat 166 fiber 40 166 fill syringe 46 48 Flow accuracy Pod 147 Flow rate error 147 food library See reference food library G glucagon 108 glucose ix 166 H hard work 119 hazard alarm manual shut off 130 hazard alarms 124 130 167 healthcare provider xi 167 hemoglobin A1c HbA1c 167 HIPAA privacy notice 158 163 history alarms 102 all 103 basal 98 blood glucose 100 bolus ...

Page 179: ... device 83 88 long acting insulin 118 low battery alert 139 low blood glucose See hypoglycemia low reservoir advisory 126 low reservoir alert 15 66 lows highs and DKA avoid 110 M manual shut off of hazard alarm 130 maximum basal rate 27 66 maximum bolus 14 66 meal bolus 30 141 144 168 meal IOB 142 Medic Alert tag 120 medical electrical equipment 151 154 menu Bolus basal calcs 63 More actions 7 31 ...

Page 180: ...water 75 version viii PDM error hazard alarm 129 PDM lock 71 137 set 73 PDM options System setup 72 personal contact information 103 Personal Diabetes Manager See PDM physical exertion 119 playing sports 119 Pod 4 43 58 applying 51 change process 43 check status 55 cleaning 137 deactivating 44 expiration reminder 66 filling 46 flow accuracy 147 flow rate error 147 inserting cannula 53 priming 48 r...

Page 181: ...tomatic priming 8 automatic safety checks 8 electrical 151 154 occlusion detection 8 safety checks 121 screen time out 71 set 73 sensitivity factor See correction factor set backlight time out 73 ID screen 72 PDM lock 73 screen time out 73 settings BG meter 70 Setup Wizard 10 sharps 169 sharps container 169 shock 44 shut off manual 130 sick days 119 soap solvent 75 137 138 soft keys ix 5 169 soft ...

Page 182: ...emporary basal presets 24 27 169 cancel 26 change 26 create 24 delete 27 enable 25 rename 27 temporary basal rate 22 27 169 temporary basal rate one time 23 test strips 3 77 78 80 85 code 86 expiration 78 text entering and changing 17 22 24 27 38 39 40 time 11 61 time segment See basal segment time zones 108 travel concerns 108 U Up Down Controller buttons 5 UserGuidesymbols viii User Info Support...

Page 183: ..._____ _________ _________ _________ _________ _________ Suggest correction when BG isabove ___________ mg dL ___________ mg dL ___________ mg dL ___________ mg dL ___________ mg dL ___________ mg dL ___________ mg dL ___________ mg dL Basal Program 2 Name _________________________________ 12 00 AM to ________ ________to ________ ________to ________ ________to ________ ________to ________ ________t...

Page 184: ... _____________ U _____________ U _____________ U Temp Basal Presets Name ________________________________________ ________________________________________ ________________________________________ ________________________________________ ________________________________________ ________________________________________ ________________________________________ Rate circle measurement ________ U hr or...

Page 185: ...______________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _____________________________________________________________________________________________________________ _______________________________________________...

Page 186: ......