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Insulet mylife OmniPod, Manual

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© 2012–2013 Insulet Corporation. All rights reserved.
mylife OmniPod is a registered trademark of Insulet Corporation.
U.S. Patent No. 6,740,059.
OneTouch® Verio™ is a registered trademark of Johnson & Johnson. 

Third-party trademarks used herein are the trademarks of their respective owners.

15858-AW Rev A

Summary of Contents for mylife OmniPod

Page 1: ...feOmniPodSystemStartDate ______________________ PDMModel ENT500SerialNumber _____________________ Distributor CustomerCare Doctor Nurse Educator Health Insurance Pharmacy XXXXXXXXXXXXXXXXXXXXXXXXXXXXX...

Page 2: ...rightsreserved mylifeOmniPodisaregisteredtrademarkofInsuletCorporation U S PatentNo 6 740 059 OneTouch Verio isaregisteredtrademarkofJohnson Johnson Third partytrademarksusedhereinarethetrademarksofth...

Page 3: ...your System 3 The Pod 4 The Personal Diabetes Manager 4 Buttons that program and control the mylife OmniPod System 5 Primary screens 6 Safety Features 8 Automatic priming safety checks and insertion 8...

Page 4: ...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 bol...

Page 5: ...ndy 77 Communicating with the Pod 77 Water and your PDM 77 Avoid extreme temperatures 77 Electrical interference 78 7 CheckingYour Blood Glucose 79 The Built in OneTouch Verio Blood Glucose Meter 79 T...

Page 6: ...e 109 Avoid lows highs and DKA 109 General precautions 109 Hypoglycemia Low Blood Glucose 109 Symptoms of hypoglycemia 110 To avoid hypoglycemia low blood glucose 110 To treat hypoglycemia low blood g...

Page 7: ...in on board IOB calculation 147 Examples of suggested bolus calculations 148 Calculator guidelines 149 mylife OmniPod System Options and Settings 151 Pod Specifications 152 AccuracyTest Results 153 Fl...

Page 8: ...entSystem ThisUserGuideisintendedforuseonlywithPDM modelENT500 TolearnwhichversionofthePDM youhave turnitover OnthebackofthePDM look for ENT500 Ifyouseeit thisisthecorrectUser Guide Ifyoudonotsee ENT5...

Page 9: ...he GlossaryattheendofthisUserGuide Press Pressandreleaseabuttonorsoftkey Hold Keeppressingabuttonuntilitsfunctionis complete Menu AlistofoptionsonthePDM Optionsallow youtoperformtasks Screen Displaysp...

Page 10: ...d Diagnosingoforscreeningfordiabetesmellitus ThemylifeOmniPodSystemisdesignedtouse rapid actingU 100insulin ThefollowingU 100 rapid actinginsulinanalogshavebeentestedand foundtobesafeforuseinthePod No...

Page 11: ...inyourbodyafteracorrectionor mealbolus Theglucosemeterandlancingdeviceareforsingle patientuse Donotsharethedevicewithanyone includingotherfamilymembers Donotuseonmul tiplepatients Partsofthedevicearec...

Page 12: ...onothesitateto talkwithyourhealthcareprovider Fornonmedicalemergencies orfortechnicalquestionsaboutyourmylifeOmniPodSystem setuporoperation youcancallCustomerCare24hoursaday 7 daysaweek CustomerCare Y...

Page 13: ...nience free dom flexibility andeaseofuse Continuousinsulindeliverymostcloselymimicstheinsulin releaseofahealthypancreas Sincethelandmark10 year DiabetesControlandComplicationsTrial DCCT thelong termhe...

Page 14: ...y thePDMseparatelyinabackpack briefcase orpurse Withthe mylifeOmniPodInsulinManagementSystem youdon thaveto worryaboutsnagging tangling orfeelingtetheredbytubing Suggestedboluscalculation Calculatingb...

Page 15: ...eter youcanenter thereadingsmanuallyintothePDM Recordkeeping AnotherconvenientpartofthemylifeOmniPodSystemisrecord keeping Paperchartsareuseful butsometimestheycanbe inconvenienttocarryoruse Thedatast...

Page 16: ...andage n ThePersonalDiabetesManager AllPodoperationsareprogrammedandcontrolledthroughthe palm sizedPersonalDiabetesManager PDM Figure1 2 Top Bottom Needle Cap ViewingWindow Fill Port Figure 1 1 Adhesi...

Page 17: ...Softkeylabelsandfunctionsdependonthe menuorscreenyouareviewing Thelabel appearsonthescreendirectlyabovethephysi calbuttonyoupress Select Save andBackare justthreeexamplesofthesoftkeylabelsonyour PDM...

Page 18: ...rd onpage10 fordetailsoncustomizingyour PDM YoumustacknowledgetheIDscreenbeforeyoucanuse thePDM ItisimportantthatyoualwaysidentifythePDMas yoursbeforeyouuseit Statusscreen ListstheSystem scurrentopera...

Page 19: ...oursold Tempbasalmenutodelivertemporarybasalrates This submenudoesnotappeariftempbasalisturnedOffin Settings Myrecordsmenutoreviewinsulindelivery bloodglucose history alarmhistory carbhistory andperso...

Page 20: ...dalarmsoundswhenanaverageof3to5unitsofmissed insulinoccurs Thistabledepictsocclusiondetectionfor3differ entsituationswhenusingU100insulin Table1 Ifanocclusionis cleared avolumeofinsulincouldbereleased...

Page 21: ...hischapteraresimplifiedtohelpyougetstarted TurnonthePDM 1 OpenthebatterycompartmentonthebackofthePDM bypushingthecompartmentlatchandliftingupward Figure2 1 Nospecialtoolsarenecessary 2 Inserttwo 2 new...

Page 22: ...UsetheUp DownControllerbuttonstoscrollthroughthe listofcharacters Anup and down arrowsymbolonthe screenindicatesthecharacterthatcanbechanged 2 PressthemiddleSoftKey labeledwiththerightarrow to movethe...

Page 23: ...basalprogramasalist pressList Toreturntothe graphicview pressGraph 5 PressSavetoacceptthebasalprogramyouhaveset 6 Chooseatemporarybasalfeature thenpressNext Choose toshowtemporarybasalratesasapercenti...

Page 24: ...teratargetbloodglucosevalue thenpressNext UsetheUp DownControllerbuttonstoenterthe cor rectabove valueor correctionthreshold theBGvalue abovewhichyouwantthePDMtosuggestacorrection bolus thenpressNext...

Page 25: ...indecreasesyourbloodglucose thenpress Next 2 Tosavethecorrectionfactor pressDone Tochangethe factor selectthesegmentyouwishtochangeandpressEdit Youcandefinecorrectionfactorsforupto8timesegments Toente...

Page 26: ...s in5 unitincrements thenpressNext SetPodexpirationnotification 1 ChoosethenumberofhoursbeforeaPodexpireswhenthe PDMshouldgiveyouanotification thenpressNext The valuesarein1 hourincrementsandrangefrom...

Page 27: ...fertoChapter5 UsingthePod for detailedinstructions YoumaywanttoadjustthePDMscreentime out andbacklighttime out Formoreinformationon howtodothis seeChapter6 UsingthePersonal DiabetesManager Usetheforma...

Page 28: ...example onepersonmayneedtodelivera higherrateofinsulinduringtheearlymorningandalowerrate duringthelateevening Abasalprogramdescribestheamount ofinsulintobedeliveredduringanentire24 hourperiod Abasalpr...

Page 29: ...salprogram ThePersonalDiabetesManagercanstoreupto7differentbasal programs Eachprogramcancontain24rates programmedin half hourincrements Onceyouenterabasalprogramintothe PDM youonlyneedtopressafewbutto...

Page 30: ...gram pressDoneandcontinuewithstep7 Or toaddbasalsegmentsandrates forexample ahigher basalratebetween08 00and15 00 a Chooseanexistingbasalsegment thenpressEdit Or choose addnew thenpressNew b Enterthes...

Page 31: ...ddtheprogramtothePDM smemory pressSave Repeatsteps1through9 above foreachbasalprogram upto7 programs youwanttocreate Enableanexistingbasalprogram 1 OntheHomescreen usetheUp DownControllerbuttons tocho...

Page 32: ...omescreen usetheUp DownControllerbuttons tochooseSettings thenpressSelect 2 ChooseBasalprograms thenpressSelect 3 Chooseaprogramfromthelist thenpressSelect Adiamondicon u appearsnexttotheprogramthat i...

Page 33: ...gmentyouwanttochange then pressNext 4 Enteranendtimeforthissegment thenpressNext 5 Enterabasalrateforthenewsegment thenpressEnter 6 Tosavethenewlyenteredsegmentintothebasalprogram pressSave Figure3 10...

Page 34: ...deleteabasalprogram Afterchoosingaprogramfromthelist pressDeletetoaccept thischangeandthenpressSelect 4 PressDeletetopermanentlydeletetheprogram n TemporaryBasalRatesandPresets Whatisatemporarybasalra...

Page 35: ...5U hr Example ifflowrateis0 10U hr youcan tcreate atempbasalof 60 Seethesectionsbelowoncreating enabling cancelling and changingtemporarybasalpresets Enableaone timetemporarybasalrate 1 OntheHomescree...

Page 36: ...ew 5 TousethemylifeOmniPodSystem sdefaultnamingsystem simplypressNext Thedefaultnamingsystemautomatically assignsprogramnamesinnumericalorder suchastemp basal1 tempbasal2 tempbasal3 Or togiveadifferen...

Page 37: ...ptit Enableanexistingtemporarybasalpreset 1 OntheHomescreen usetheUp DownControllerbuttons tochooseTempbasal thenpressSelect 2 Choosethetemporarybasalpresetyouwanttousefromthe list Figure3 15 thenpres...

Page 38: ...Controllerbuttons tochooseSettings thenpressSelect 2 ChoosePresets thenpressSelect 3 ChooseTempbasalpresets thenpressSelect 4 Chooseatemporarypresetfromthelist thenpressEdit Tochangeatemporarybasalpre...

Page 39: ...mitsthebasal rate U hr thatthePodcandeliver Onceyouenteritintothe PDMmemory themaximumappliestobothregularbasalpro gramsandtemporarybasalrates Youandyourhealthcareproviderwillenteraninitialmaximum bas...

Page 40: ...rateratio Yourcorrectionfactor Yourtargetbloodglucoseandcorrectabovethreshold Theamountofinsulinonboard IOB activeinsulin frompre viousmealandcorrectionboluses Yourcorrectionthreshold theBGlevelabovew...

Page 41: ...gestedboluscalculatorOnorOff seeChapter6 Usingthe PersonalDiabetesManager IfthesuggestedboluscalculatoristurnedOn theSystem automaticallycalculatesabolusdose Ifthesuggestedbolus calculatoristurnedOff...

Page 42: ...tionbolus Thecorrectionbolus asthenamesuggests corrects forabloodglucose BG levelaboveyourtargetBG level Mealbolus Themealbolusprovidesinsulinforthecarbohy dratesyouenterintotheSystem Insulinonboard I...

Page 43: ...etestyour bloodglucoseinordertoincludeitinthesuggested boluscalculator Whenyourbloodglucoseresultreads HIGH or LOW thesuggestedboluscalculatorwillbe disabled Ifyouuseaseparatebloodglucosemeter notthe...

Page 44: ...hatyouaregoingtoeat then pressEnter UsetheUp DownControllerbuttonstochoose favorites snacks ormeals Fromthere selectacarb presetyouhavepreviouslyentered see CarbPresets laterinthischapter thenpressSel...

Page 45: ...nfirmtobeginthebolusdelivery IfthereversecorrectionfeatureisturnedOnandif yourbloodglucoselevelisbelowyourtarget the Systemsubtractsacorrectionamountfromthemeal portionofthebolus Ifthereversecorrectio...

Page 46: ...etyoursuggestedbolus pressExtendinsteadof Enter seeFigure4 7 2 Entertheunitsofinsulinorpercentageofthebolusthatyou wanttotakeimmediately Figure4 8 thenpressEnter Figure 4 7 IfyouhavesettheExtendedbolu...

Page 47: ...ivery Figure 4 9 Figure 4 10 Asasafetyfeature thecorrectionbolusisalways deliveredfirstandcannotbeextended Onlythe mealboluscanbeextended Forexample Totalbolus 5units correctionbolus 1unit mealbolus 4...

Page 48: ...4 11 2 PressCancel ThePodbeepstoconfirmthebolusiscancelled Anon screen messagetellsyouhowmuchinsulinwasdeliveredbefore youcancelledthebolus Figure4 12 3 PressOKtoreturntotheStatusscreen n ReplaceanExt...

Page 49: ...turn totheSuggestedMealBolusscreen n BolusPresets Boluspresetsarebolusamountsthatyouprogramforfrequent use Forexample ifyouoftentakethesamebolusatlunchtime youcancreateaboluspresetforthatamountandname...

Page 50: ...owsymbolonthescreenindicateswhichcharactercan bechanged b PressthemiddleSoftKey labeledwiththerightarrow to movetheunderscoretothenextcharacter c Entereachcharacteroneatatime Forexample ifyou frequent...

Page 51: ...sstheUp DownControllerbuttonstoenterthecharac tersthatspelloutthenameyouwant thenpressNext Deleteaboluspreset 1 ChooseDelete andthenpressSelect 2 PressDeletetopermanentlydeletethepreset Cancelanactive...

Page 52: ...carbpreset3 Or togiveadifferentnametotheprogram a PresstheUp DownControllerbuttonstoenterthechar actersthatspellthenameyouwant Anupanddown arrowsymbolonthescreenindicatesthecharacterthat canbechanged...

Page 53: ...tegoryofthepresetyouwanttochange then pressSelect Figure4 19 Tochangethecategoryforacarbpreset 1 Choosethecarbpresetyouwanttomovetoanothercate gory thenpressTag Figure4 20 2 Chooseanewcategory thenpre...

Page 54: ...ForEuropeanfood labeldonotenterthefiber becauseitisalreadycountedoff thecarbohydrate PressNext 6 Ifyouwant enterthegramsoffatandproteininthemeal andthetotalcalories PressNextaftereachentry 7 PressSave...

Page 55: ...magedinanyway Adam agedPodmaynotworkproperly Tominimizethepossibilityofsiteinfection doNOTapplya Podwithoutfirstusingaseptictechnique Thismeansto washyourhands cleantheinsulinvialwithanalcoholprepswab...

Page 56: ...ngon page8oftheIntroductionforalistofinsulinsapprovedfor useinthemylifeOmniPodSystem AnunopenedPod Analcoholprepswab DeactivatethecurrentPod 1 OntheHomescreen usetheUp DownControllerbuttons tochooseMo...

Page 57: ...ndremovetheentirePod Figure5 5 b Usesoapandwatertoremoveanyadhesivethatremains ontheskinor ifnecessary useanadhesiveremover c DiscardtheusedPodaccordingtolocalwastedisposal regulationsorcontactCustome...

Page 58: ...styou72hours Yourhealthcare providerwillhelpyoudeterminethecorrectamount BeforefillingaPod ensurethatnootherPodsare beingactivatedwithin61cm 24inches ofyour PDM BeforefillingaPodwithinsulin ensurethat...

Page 59: ...rtontheundersideofthePod Figure5 10 Anyairbubblespresentinthefillsyringecouldbe transferredintothereservoirduringthefillprocess Thepoddoesnotpurgeairthatisintroducedintothe reservoirbywayofcustomerfil...

Page 60: ...pleasecallCustomerCare 14 TheSystemperformsaseriesofsafetychecksandautomati callyprimesthePod Figure5 12onnextpage Oncecom plete thePDMbeeps lettingyouknowthattheprimingand safetychecksweresuccessful...

Page 61: ...led itwillbeep every5minutestoindicatethattimeispassing Ifyou donotsetupthePodwithin60minutes youmust deactivateanddiscardit OnceaPodisactivatedandcommunicateswiththe PDM itcanonlyreceivecommandsfromt...

Page 62: ...acleantowel 4 Useanalcoholprepswabtodisinfecttheinfusionsite Startat thecenterofthesiteandgentlyruboutwardinacircular motion 5 Letthesiteair drythoroughly Donotblowonthesitetodry it Figure 5 13 Pod pl...

Page 63: ...lydropped discardit sterilitymaybe compromised IfyouareunsurethePodisreadytobeappliedtothesite press Discard anddonotuseit Figure5 17onthenext page SelectanewPod 3 Usingthepulltabs removeanddiscardthe...

Page 64: ...nFigure5 16 c Atleast2 5cm 1inch awayfromthelastsite Figure 5 13 a b Figure 5 16 Figure 5 17 ThePod sadhesivekeepsitsecurelyinplaceforupto 3days However ifnecessary severalproductsare availabletoenhan...

Page 65: ...fillthe cannulawithinsulin Figure5 20 Oncethesoftcannulaisinserted thePDMindicatesthatthePod isactive Figure5 21 IfyouareapplyingaPodinaplacethatdoesnothave alotoffattytissueorisverylean pinchtheskin...

Page 66: ...arttheprocesswith anewPod Checktheinfusionsiteafterinsertiontoensure thatthecannulawasproperlyinserted You shouldcheckyourbloodglucose1 5to2hours aftereachPodchangeandchecktheinfusionsite periodically...

Page 67: ...reservoirvolume PDMbattery level lastbloodglucosevalue lastbolusdose activebasalpro gram andanyalarmconditions SeeChapter6 Usingthe PersonalDiabetesManager fordetailsofwhatyouseeonthe Statusscreen Ift...

Page 68: ...irmthatyouwanttohaltallinsulin delivery basalandbolus ThePDMbeepsandanon screen messageletsyouknowthatinsulindeliveryisnowsus pended Figure5 25 ThePodbeepsevery15minutesuntiltheendofthesuspen sionperi...

Page 69: ...usetheUp DownControllerbuttons tochooseResume Figure5 27 thenpressSelect 2 PressConfirmtorestartthebasalprogramforthattimeseg ment TheAdvisoryalarmrepeatsevery15minutesuntilyou pressOK Insulindelivery...

Page 70: ...MostFromYourPod Avoidextremetemperatures ThePod soperatingtemperatureisbetween4 4 Cand40 C between40 Fand104 F Undernormalcircumstances your bodytemperaturewillkeepthePodwellwithinthisrange Waterandyo...

Page 71: ...tes Check oftentomakesurethePodandsoftcannulaare securelyattachedandinplace Ifthecannulaisnot properlyinserted hyperglycemiamayresult Verify thereisnowetnessorscentofinsulin whichmay indicatethecannul...

Page 72: ...andthePDMisturnedon thePDMestab lishescommunicationwiththePodtoobtainastatuscheck Duringthestatuscheck thePDMcollectsinformationfromthe Podaboutbolusdeliveries activebasalprograms andPodexpi ration Th...

Page 73: ...ys 50 U Oncethereservoirvolumedropsto50 units thegaugecountsdownunitbyunit Whenthevolume fallsbelow5units thedisplaychangesto LOW PDMsettings YoucanadjustthePDMsettingstomeetyourindividualneeds 1 From...

Page 74: ...ude Dateandtime Bolusdoses basalrates andboluscalculatorsettings Alertsandreminders Bloodglucosemetersettingsandtags PDMoptions Diagnostics YouandyourhealthcareproviderenteredinitialSystemsettings usi...

Page 75: ...setheUp DownControllerbuttons tochooseSettings thenpressSelect 3 ChooseSystemsetup thenpressSelect 4 ChooseDate time thenpressSelect 5 ChooseeitherDateorTime thenpressEdit Resetthetime 1 Toenterthecur...

Page 76: ...syourneedschange Checkwithyourhealthcare providerbeforemakinganychanges 1 OntheHomescreen usetheUp DownControllerbuttons tochooseSettings thenpressSelect 2 ChooseSystemsetup thenpressSelect 3 ChooseBo...

Page 77: ...mentsandaddsegments uptoatotalof8 a ToeditanexistingICratiotimesegment choosetheseg ment thenpressEdit Figure6 7onnextpage Usethe Up DownControllerbuttonstochooseanewstarttime endtime andICratio Pres...

Page 78: ...ller buttonstochooseanewstarttime endtime targetBG value andcorrect abovevalue correctionthreshold PressNextaftereachentry b Toaddasegment choose addnew thenpressNew UsetheUp DownControllerbuttonstoch...

Page 79: ...letedalltimesegments press Done thenSave 5 Reversecorrection ChooseOnorOff thenpressSelect 6 Insulinaction duration orInsulinonBoard IOB Use theUp DownControllerbuttonstochooseadurationof insulinactio...

Page 80: ...cknowledgeit Lowreservoir AlertsyouwheninsulininthePodreachesacer tainlevel soyoucanplanaheadtochangethePod Choosea levelfrom10to50units in5 unitincrements Thedefaultsetting is10units Auto off Alertsy...

Page 81: ...becomefamiliarwiththeoperationof themylifeOmniPodSystemandfeelconfidentthatyouareget tingtheinsulinyouneed Thesenotificationsinclude Bolusdeliverystarted Bolusdeliverycompleted Extendedbolusstarted Ex...

Page 82: ...deleteaBolusreminder a Choosethebolusreminderyouwishtodelete then pressEdit b ChooseDeletethenpressSelect c PressDeletetoremovethebolusreminder 7 ForCustomreminders UsetheUp DownControllerbuttonstocho...

Page 83: ...canadjustbloodglucose BG metersettings BGgoallowerandupperlimits forBGhistory ManageBGtagslist BGsound OnorOff 1 OntheHomescreen usetheUp DownControllerbuttons tochooseSettings thenpressSelect 2 Choos...

Page 84: ...astandardBGtag choosethetag andpress Show ifitismarkedashidden orHide Tagsyouchoosetoshowwillbecheckmarked hiddenones willnotbe 2 Toaddacustomtag choose addnew attheendofthelist ofcustomtags thenpress...

Page 85: ...thinthe timeintervalthatyouset Setatthelowestsettingtomaximize batterylife SetPDMoptions 1 OntheHomescreen usetheUp DownControllerbuttons tochooseSettings thenpressSelect 2 ChooseSystemsetup thenpress...

Page 86: ...then pressSelect SetPDMlock ChooseOnorOff thenpressSelect SettheScreentime out Chooseatimeinterval thenpressSelect Whenthescreentimesoutandgoesblack turnitonagainby pressingtheHome Powerbutton SettheB...

Page 87: ...etimesandvibratesthree times IfthePodisactive itbeepsthreetimes thensounds thealarmtonefor5seconds ToresetthePDM 1 ChooseResetPDM thenpressSelect 2 IfthePodisdeactivated thePDMasksforconfirmationand r...

Page 88: ...setheUp DownControllerbuttonstochooseSettings thenpressSelect 2 ChooseVibration thenpressSelect 3 ChooseVibrate Vibratethenbeep orOff beeponly then pressSelect VibratethenbeepmeansthePDMwillrepeat the...

Page 89: ...atingwiththePod WhenyouusethePDMtocommunicatewiththePod holdthe PDMwithin152cm 60 ofthePod WaterandyourPDM Avoidextremetemperatures ExtremeoperatingtemperaturescandamagePDMbatteries andinterferewithSy...

Page 90: ...ample electricappliancessuchasmicro waveovensandelectricmachinerylocatedinmanufacturing environmentsmaycauseinterference Inmostcases interrup tionsareeasytoresolve seeChapter11 Communication Failures...

Page 91: ...utodoso KeepthesystemandtheOneTouch Verio accesso riesawayfromyoungchildren astheycontainsmall partsthatmaybedangerousifswallowed OnlyuseOneTouch Verio teststripsandOne Touch Verio controlsolutionwith...

Page 92: ...DoNotgetdirt food orliquidsontheteststrip Youmay touchtheteststripanywhereonitssurfacewithclean dry hands DoNotbend cut oralterteststripsinanyway Teststripsareforsingleuseonly Neverreuseateststripthat...

Page 93: ...drepeatedunexpectedbloodglucoseresults Ifyoudropordamagethemeter Checkthatthemeterandteststripsareworking Acontrolsolutiontestfollowsthesameprocedureasablood glucosereading exceptthatyouuseasampleofco...

Page 94: ...tmustbeperformedbetween43 and 111 F 6 and44 C Ifyourcontrolsolutiontestresultscontinuetofalloutsidethe rangeprintedontheteststripvial 1 TheSystemmaynotbeworkingproperly 2 DonotusetheSystemtotestyourbl...

Page 95: ...Figure 7 2 Channel to apply sample OneTouch Verio test strip Silver prongs insert into test strip port AlwaysverifythatyouareusingOneTouch Verio teststripswithyourPDM Figure7 4 FromsomePDMscreens youc...

Page 96: ...of the cap with a clean damp tissue or cloth Next squeeze a drop into the small well on the top of the cap or onto another clean non absor bent surface 6 GentlytouchonlyONESIDEoftheteststriptothecontr...

Page 97: ...igure7 9showsthepartsofthelancingdevice If the words Control solution do not show on the screen you MUST tag this result as a control solution test If you do not mark this result as a control solution...

Page 98: ...e device turn clockwise to secure the cap Figure7 13 Becarefulnottotouchthe exposedneedleonthelancet 5 Thelancingdevicehassevenpuncturedepthsettings num bered1through7 Smallernumbersareforashallowerpu...

Page 99: ...toff press Lightagain 3 Insertonlythebottomendofthestripintotheteststripport Figure7 16andFigure7 17 Consultyourlancingdeviceinstructionstoensure properusage Figure 7 14 Figure 7 15 FromsomePDMscreens...

Page 100: ...ropofbloodformsonyourfingertip 4 Bringthestriptothebloodsampleataslightangle Figure7 18 Ifyoudonotapplythesamplewithin10seconds thestrip portlightturnsoff Toturnitonagain pressLight Useonlyoneedgeofth...

Page 101: ...ntendedforindividualuseand shouldnotbeshared Ifthedeviceisbeingoperated byasecondpersonwhoisprovidingtestingassis tancetotheuser themeterandlancingdevice shouldbedecontaminatedpriortousebythesec ondpe...

Page 102: ...betesManager b PressOKtoreturntothereadingscreen Figure7 24 thenpressNext 4 Ifyoudonotwanttomarkthetest pressNextinsteadofTag 5 Removetheteststrip Ifthestrip portlightwasturnedon it nowturnsoff Remove...

Page 103: ...atusscreentoseethemost recentBGresult TheBGresult eitherfromthePDMorfrommanualentry is storedintheSystem shistory whethersuggestedboluscalcula toristurnedOnorOff See BloodGlucoseRecords inChapter 8 Un...

Page 104: ...oassignatagtothereading PressOKwhenfin ished Foranexplanationofenteringtags seepage90 5 PressSavetosavethereading OrpressCanceltoreturntotheMoreactionsmenuwithout savingthereading TheBolusEntryscreend...

Page 105: ...gtowhichyouhavealready assignedoneortwotags OrpressDonetoreturntotheMoreactionsmenu 4 UsetheUp DownControllerbuttonstochoosethefirsttag youwant thenpressSelect Figure7 26onthenextpage A diamondiconapp...

Page 106: ...etestwithanewteststripon yourfingers Ifyoustillgeta LOWTreatyourlowBG reading performacontrolsolutiontesttoensureyoursystemisworking properly Ifthesystemisworkingproperly followyourhealth careprovider...

Page 107: ...ealthcareprovider Ifyouareexperiencingsymptomsthatarenotconsistent withyourbloodglucosereadingandyouhavefollowedall instructionsdescribedinthisUserGuide callyourhealthcare providerimmediately Donotuse...

Page 108: ...reatrisk DoNOTremovetheoldbatteriesuntilyouhavenew onesonhand ThePDMprotectsdatainthemem oryforupto2hoursafterthebatteriesrunoutorare removed Recordswithaquestion marksymbolnexttothemhave additionalin...

Page 109: ...delivered Figure8 2 Pressthe Up DownControllerbuttonstoviewthesummaryfor previousdays Whereveryouseethe symbol presstheUserInfo Support buttontoseeadditionalinformation 3 Toreviewyourbasalhistorybyday...

Page 110: ...hatwasinterruptedduetoaPodalarm Poddeacti vation orusercancellation Thescreenshowstheamountof thebolusorbasalthatremainedundelivered 4 PressDaytoreturntodates 5 Toreviewyourbolushistorybyday pressBolu...

Page 111: ...henpressSelect 2 ChooseBGhistory thenpressSelect ThePDMdisplaysthecurrent daytrendsfirst Figure8 5 including Numberofdaysandnumberofbloodglucose readings n Averagebloodglucose AvgBG Lowestandhighestbl...

Page 112: ...4 PressClosetoreturntotheListview 5 PressGraphtoseeagraphofthedata Figure8 9 Viewmultiple daytrends 1 OntheHomescreen usetheUp DownControllerbuttons tochooseMyrecords thenpressSelect 2 ChooseBGhistory...

Page 113: ...hedate time andtypeofeachalarm Figure8 12 3 PresstheUp DownControllerbuttonstoseeadditional screens 4 Chooseanalarmrecord thenpressUserInfo Supportto seemoreinformation n CarbohydrateRecords ThePDMdis...

Page 114: ...heUp DownControllerfordates n UserInformation Support Youoryourhealthcareprovidermayhaveenteredpersonal contactinformationduringyourstart upvisit Toviewthisinfor mation presstheUserInfo Supportbutton...

Page 115: ...M a i n space S t period Ablankcharacterorspaceisthefirst andlastoptioninthescrollingmenu Foryourhealthcareproviderandlocalphonenumber you mightenterJ a n e space S m i t h comma space 5 5 5 hyphen 1...

Page 116: ...fuldiabetesmanagement Beingactivelyinvolvedinyourtreatment Checkingyourbloodglucoselevelsfrequently Washingyourhandsanddisinfectinginfusionsitestoreduce thepossibilityofinfection Beingawareofthesignso...

Page 117: ...ctedbyyourhealthcareprovider Inspecttheinfusionsitedaily Atleastonceaday usethePod sviewingwindowtoinspectthe infusionsite Checkthesiteforsignsofinfection suchaspain swelling redness dischargeorheat I...

Page 118: ...odisinterrupted Bloodglucoseteststrips Ketoneteststrips Lancingdeviceandlancets Glucosetabletsoranotherfast actingsourceof carbohydrate Alcoholprepswabs Acopyoftheletterfromyourhealthcarepro viderfora...

Page 119: ...t see PrepareforEmergencies on page106 Itmaybedifficultorimpossibletogetinsulinor suppliesinanunfamiliarplace Iftravelingbyair besuretopack yoursuppliesinyourcarry onluggage Whenpackingfortravel takem...

Page 120: ...mniPod equipment Prescriptionsforallmedicationsandsupplieswithorigi nalprescriptionlabels ScreeningProcedures Theairportmayoffertheoptionofrequestingavisualinspection ofyourmedicalsuppliesratherthanpu...

Page 121: ...tembypracticingpropertechniquesandbyactingpromptly atthefirstsignoftrouble Youcanavoidpotentialproblemsby knowingthesignsofhypoglycemia lowbloodglucose hyper glycemia highbloodglucose anddiabeticketoa...

Page 122: ...renessorasevereadverse reaction Keepaglucagoninjectionkitwithyouremergencysupplies Teachfriendsandfamilymembershowtogiveaglucagon injectionincaseyouhaveseverehypoglycemiaandbecome unconscious Hypoglyc...

Page 123: ...inafter15minutes 3 Ifbloodglucoseremainslow eatanother15gramsof carbohydrate Contactyourhealthcareproviderasneeded forguidance 4 Repeatsteps2and3untilbloodglucoseiswithintheBGgoal 5 Investigatepossibl...

Page 124: ...ce 6piecesofhardcandy 1 2canofregular non diet soda 30millilitersoftablesugarorhoney Teachpeopleyoutrust likefamilymembersand closefriends howtogiveaglucagoninjection You willneedtorelyonthemtogiveitt...

Page 125: ...ussizeandtiming DoNOTovercorrectforpost meal glucoselevels Checkcarbintake Consulthealthcareproviderfor guidance Bolustoolarge Possiblecauseoflow bloodglucose Suggestedaction Incorrecttarget bloodgluc...

Page 126: ...vityandtreatas necessary Consultyourhealthcareprovider aboutadjustingyourbasalpro gramsorusingatemporary temp basalrate Lowcarbohydrate intakepriorto activity Consumecarbohydratebefore activity especi...

Page 127: ...es Ifketonesarepresent followyourhealthcare provider sguidelines 3 Ifketonesarenotpresent takeacorrectionbolusaspre scribedbyyourhealthcareprovider 4 Checkbloodglucoseagainafter2hours 5 Ifbloodglucose...

Page 128: ...e temperatures Infusionsiteinor nearascarormole DeactivateandremoveusedPod ApplyanewPodinadifferent location Infectedinfusionsite DeactivateandremoveusedPod ApplyanewPodinadifferentloca tionandconsult...

Page 129: ...ustoosmall High proteinor high fatmeal Calculateprotein fatintakeand accountforitinyourbolustiming andbolustype Consulthealthcareproviderabout usingtheextendedbolusoption Lessactivitythan normal Consu...

Page 130: ...sofDKA Nauseaandvomiting Abdominalpain Dehydration Fruity smellingbreath Dryskinortongue Drowsiness Rapidpulse Laboredbreathing ThesymptomsofDKAaremuchlikethoseoftheflu Before assumingyouhavetheflu ch...

Page 131: ...ns Sickdays Anyphysicalstresscancauseyourbloodglucosetorise andill nessisaphysicalstress Yourhealthcareprovidercanhelpyou makeaplanforsickdays Thefollowingareonlygeneral guidelines Whenyouareill check...

Page 132: ...roductsmayloosentheadhesive Forsomecontactsports youmaywanttoremovethePod Besuretocheckyourbloodglucoselevelsbeforeremovingthe Podandafterapplyinganewone Podsaredesignedforone timeuse Donotattempttore...

Page 133: ...orhospitalstaffaboutyourinsulinPod Itmay benecessarytoremoveitforcertainproceduresortreatments Remembertoreplacethebasalinsulinthatwasmissedwhilethe Podwasremoved Yourhealthcareprovidercanhelpyoupre p...

Page 134: ...ouawareofaseriousorpotentiallyserious condition theSystemsoundsanalarmanddisplaysanon screenmessage Themessagehasinstructionsfortakingcareof thealarmcondition Alarmconditionsareeasytohandle They areno...

Page 135: ...em with the meter 1 Repeatthetestwithanewteststrip 2 Iftheerrorpersists callCustomerCareorrepeatthebloodtest BGMeterError3 Meter was not ready Retest with a new strip The sample was applied before the...

Page 136: ...ter 1 Retestusinganewteststrip DonotpressanybuttonsorSoftKeys whileapplyingbloodorcontrolsolutiontotheteststrip 2 Iftheerrorpersists callCustomerCareorperformanotherbloodtest BGMeterError5 Strip probl...

Page 137: ...peratingrange 43 111 F IfyoudonotgetanotherTemperaturetoohighmessage you canproceedwithtesting Temperaturetoolow Outofoperating range Forcustomersupport call800 591 3455 Meteristoocold below 43 F towo...

Page 138: ...Statusscreen ThePDMcommunicateswiththePod if necessary andthescreendisplaysamessagedescribingthe alarmandhowtoresolveit Alladvisoryalarmsaretimesensitive andrequirearesponse Someadvisoryalarmsescalate...

Page 139: ...hePDMwillremindyouofthis Duetotheseriousnatureofhazardalarms youmust actpromptlytoresolvethem 1 Acknowledgethealarmconditionbypressing OK whichsilencesthealarm 2 DeactivateandremovetheactivePod seeCha...

Page 140: ...tsevery15minutesuntil insulindeliveryisresumed PressOKtoresumeinsulindeliveryat programmedbasalrate Auto offalert Advisory Alarm Pod and PDM 2setsofbeepseveryminutefor15 minutes EscalatestoAuto offhaz...

Page 141: ...severyminutefor3 minutes Repeatsevery60minutesuntil acknowledged EscalatestoEmptyreservoir hazardalarmwhenempty PressOKtoacknowledge Emptyreservoir Insulindeliverystopped ChangePodnow Hazard Alarm Pod...

Page 142: ...hangePod SeeChapter5 Usingthe Pod Podexpired Insulindeliverystopped ChangePodnow Hazard Alarm Pod and PDM Continuoustone ThisalarmoccurswhenthePodhas reachedtheendofitsoperatinglife PressOKtoacknowled...

Page 143: ...now Hazard Alarm Pod or PDM Continuoustone ThisalarmoccurswhenthePoddetects anunexpectederror PressOKto acknowledge ChangePod Checkbloodglucose PDMError RemovePodnow Forcustomersupport refertoyourUser...

Page 144: ...ose SystemError Removepodnow Forcustomersupport refertoyourUserGuide Hazard Alarm Pod or PDM Continuoustone Thisalarmoccursifanunexpectederror isdetectedinthePodorPDM PressOK toacknowledge RemovePod N...

Page 145: ...tivationrequired PressOKtodeactivate Hazard Alarm PDM Continuoustone ThisalarmoccursafteraPDMerror occursthatrequirestheusertoresetthe dateandtime PressOKtoacknowledge ChangePod Checkbloodglucose Alar...

Page 146: ...Pod Theportcanbefoundbypeelingbacktheadhe sivepadfromthebottomofthePodatthesquareend The alarmshut offportistotherightofthefillport 3 Pressthepaperclipstraightdownintothemanualalarmshut offportuntilth...

Page 147: ...Alerts and Alarms 135 10...

Page 148: ...byoutsideinterference Seethe mylifeOmni PodSystemNoticeConcerningInterference intheAppen dix n FailureDuringPodActivationorOperation WhenyousendaninstructionfromthePDM suchasStartto beginbolusdelivery...

Page 149: ...iththePodagain Ifitcannotcommuni cate itdisplaysthesamescreenasinFigure11 2 thenfinallythe Communicationtime out screen Figure11 3 PressOKtocheckthePodstatus b Ifthestatuscheckfails youwillseethescree...

Page 150: ...wereactivatingaPod theSystemreturnstothepre viousscreenwhereyoucancontinueactivation Ifyou wereissuinganyothercommand theSystemreturnsto theStatusscreen whereyoucanreissuethecommand n FailureDuringPod...

Page 151: ...eiconisasoftkeylabeledSkip Either 1 Waituntilyouseethe Podstatusnotavailable screen Figure11 10 Or 2 PressSkiptoskipthecommunicationprocessandimmedi atelybringupFigure11 10 Ifyouhaveanunconfirmedcorre...

Page 152: ...ePDMtocancelabolus ifthePDMcannot sendyourinstructiontothePodwithinafewseconds itdisplays the Communicationerror screen Figure11 12 1 MovethePDMclosetothePod ThePDMtriestocommuni catewiththePodagain 2...

Page 153: ...eginthedeactivation process 4 IfatanypointinthisprocessthePDMcancommunicate againwiththePod youwillseeFigure11 15 Themessage indicatesthatyouroriginalinstructiontocancelthebolus wassuccessful a PressO...

Page 154: ...oapand water However donotusestrongdetergentsorsolvents They candamagethePod scasingorirritatetheinfusionsite n PersonalDiabetesManagerCareandMaintenance Storage WhenyouarenotactivelyusingthePersonalD...

Page 155: ...leaningordisinfecting 2 TocleananddisinfecttheoutsidesurfacesofthePDMhous ing useDispatch HospitalCleanerDisinfectantTowelswith Bleachoritsformulaequivalent availableonlinethrough majorretailers 3 Fol...

Page 156: ...eicons ThePDMautomaticallyalertsyouwhenitsbatterypowergets low seeFigureA 2 Whenyouseethe LowPDMbattery alert pressOKtoturnoffthealert Replacethebatteriesassoonas youcan AAAalkalinebatteriesaretherequ...

Page 157: ...removethebatteriesand discardthem 3 Useaclean lint freeclothtogentlyabsorbanywaterinthe batterycompartment 4 LeavethebatterycompartmentdooropenuntilthePDMis thoroughlydry 5 Donotputinfreshbatteriesor...

Page 158: ...mniPodSystemproductsandsupplies call CustomerCare IfyourPDMisdamagedornotworkingasit should pleasecallCustomerCareforassistance Besuretocheckyourbloodglucosefrequently RemoveyourPodandcontactyourhealt...

Page 159: ...g dL 50CF 0 5unitsreversecorrectionbolus reducesmealbolus Mealboluscalculation Carbsentered insulin to carb IC ratio Exampleofmealbolus Carbsentered 45gramsofcarb Insulin to carbratio 15 45carbs 15ICr...

Page 160: ...rrectionfactor CF 50 Durationofinsulinaction 3hrs Example1 CurrentBGlevel 150mg dL Carbintake 0gramsofcarbohydrate carbs MealIOB 1unit CorrectionIOB 1unit Correctionbolus 150mg dL current 100mg dL tar...

Page 161: ...sted bolusdoses Suggestedbolusdosesareroundeddowntothenearest 0 05U Ifthetotalofthesuggestedboluscalculation correction bolusplusmealbolus islessthanzero thesuggestedbolus doseis0 00U TheSystemwillnot...

Page 162: ...odglucose valueandyouhavesetreversecorrectiontoOn thesug gestedcorrectionbolusissubtractedfromthesuggested mealbolus IfyouhavesetreversecorrectiontoOff the Systemwillnotsubtractinsulinfromthesuggested...

Page 163: ...utesto4hoursafter bolusisstarted in30 minute increments DefaultisOff Bloodglucosemetersound OnorOff DefaultisOn Suggestedboluscalculator OnorOff DefaultisOn TargetBGvalueand correctionthreshold 8times...

Page 164: ...ngatmosphericpressure 696hPAto1060hPA Storageatmosphericpressure 696hPAto1060hPA Non pyrogenic Fluidpathwayonly TypeBFMedicalDevice Protectionfromelectricalshock FlowCapability Basal Programmablebythe...

Page 165: ...accuracyofthe Podagainstgiventimeperiods Flowrateerror Thefollowingtrumpetcurveshowstheaccuracyofthedelivery rateinrelationtotheobservationperiod Themeasurements weremadeusingaPodwithabasalrateof0 05U...

Page 166: ...peratingatmosphericpressure 696hPAto1062hPA Storageatmosphericpressure 703hPAto1062hPA Communicationdistance AtstartupthePDM and Pod should beadjacentandtouching eitherinoroutoftraytoensureproper comm...

Page 167: ...ialnumber TypeBFmedicaldevice protectionfromelectricalshock Manufacturer Non pyrogenic fluidpathwayonly NotMRI safe Waterproofto7 6metersforupto60minutes Keepdry Symbol Meaning Storagetemperature Dono...

Page 168: ...nu Advisoryalarm Homescreen Alternating Hazardalarm Insulingauge Alert Applybloodsample Bloodglucoserecords PDMlock SetupWizard Battery3 4full Batteryfull Battery1 4full Batteryhalffull Basalprogram B...

Page 169: ...hePDMgenerate use andcanradiateradio frequencyenergy andmaycauseharmfulinterferencetoradio communications Therearenoguaranteesthatinterferencewill notoccurinaparticularinstallation IfthemylifeOmniPodS...

Page 170: ...chasinwork environments theSystemshouldbeobservedtoverifynormal operationinthissetting TheSystemcommunicatesbylowlevelRFenergy AswithallRF receivers thepotentialfordisturbanceexists evenwithequip ment...

Page 171: ...ancelevel ofthisdevice Electromagneticenvironment ElectroStaticDischarge ESD IEC61000 4 2 contactdischarge 6kV airdischarge 8kV 8kV 15kV Iffloorsarecoveredwithsyntheticmaterial trytoavoidelectro stati...

Page 172: ...At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflections from struc tures...

Page 173: ...35 P 800MHzto2 5GHz d 0 7 P 0 01 0 12 0 035 0 070 0 1 0 37 0 11 0 22 1 1 17 0 35 0 7 10 3 70 1 11 2 21 100 11 7 3 5 7 0 For transmitters rated at a maximum output power not listed above the recommende...

Page 174: ...U hr Basalsegment timesegment Thetimeperiodduringwhichaspecificbasalrateisdelivered BGgoal Arangeofbloodglucoselevelsthatyouaretryingtoachieve duringacertainperiodoftheday Forexample youmaywant oneBGg...

Page 175: ...tions ofdiabetes Harmfuleffectsofdiabetessuchasdamagetotheeyes kidney heart bloodvessels nervoussystem teethandgums feet and skin Correctionbolus Anamountofinsulintakentocompensateforhighbloodglucose...

Page 176: ...endingonthetypeofinsulinyoutake Onlyuserapid acting insulinwiththemylifeOmniPod InsulinManagementSystem Extendedbolus AfeatureofthemylifeOmniPodSystemthatallowsamealbolus dosetobegivenoveranextendedpe...

Page 177: ...rmonethathelpsthebodyuseglucoseforenergy Thebeta cellsofahealthypancreasmakeinsulin Insulinonboard IOB activeinsulin Theamountofinsulinthatisstill active inthebodyfromaprevi ousbolusdose InthemylifeOm...

Page 178: ...bydividingthegramsofcarbohydratesyouareabouttoeatby yourinsulin to carbohydrateratio Multipledailyinjections MDIs Introducinginsulinintothebodywithasyringeseveraltimesa day Occlusion Ablockageorinter...

Page 179: ...ificsettings andinputs Thesettingsusedtocalculateasuggestedbolusare targetBG insulin to carbohydrate IC ratio correctionfactor CF anddurationofinsulinaction Theinputsusedtocalculateasug gestedbolusare...

Page 180: ...expiration reminder 68 program reminders 69 aseptic technique 58 162 automated cannula insertion 2 53 auto off alert 68 B backlight time out 73 set 74 basal history 97 basal program 11 16 22 162 add...

Page 181: ...ry basal rate 24 temporary basal presets 26 cannula 2 163 automated insertion 8 53 carb presets 2 40 42 163 change 41 change category 41 create 40 delete 42 edit 41 42 rename 42 carbohydrate 1 163 cou...

Page 182: ...dawn phenomenon 163 deactivation See Pod deactivating delete basal program 22 bolus presets 39 bolus reminder 70 carb presets 42 temporary basal presets 27 diabetes 164 Diabetes Control and Complicati...

Page 183: ...101 all 102 basal 97 blood glucose 99 bolus 98 carbohydrates 101 insulin delivery 96 97 Home screen 6 7 Home Power button 5 hospitalization 121 hyperglycemia 104 114 118 165 avoiding 115 causes 116 sy...

Page 184: ...48 Medic Alert tag 121 medical electrical equipment 157 161 menu Bolus basal calcs 64 More actions 7 31 My records 7 Settings 7 Suspend resume 7 System setup 62 Temp basal 7 microwave ovens 78 Min BG...

Page 185: ...illing 46 flow accuracy 153 flow rate error 153 inserting cannula 53 priming 48 removal 44 45 120 safety checks 48 specifications 152 storage 142 Pod error hazard alarm 131 Pod expiration advisory 130...

Page 186: ...s 7 5 167 soft reset See reset PDM special symbols in record screens 96 specifications BG meter 154 PDM 154 Pod 152 sports 120 Status screen 6 7 60 61 storage 59 storage temperatures 152 154 stuck key...

Page 187: ...one time 23 test strips 3 79 80 82 87 text entering and changing 17 22 24 27 38 39 40 time 11 63 time segment See basal segment time zones 107 travel concerns 107 U Up Down Controller buttons 5 UserG...

Page 188: ..._________ _________ _________ _________ _________ Suggest correction when BG is above __________ mg dL __________ mg dL __________ mg dL __________ mg dL __________ mg dL __________ mg dL __________...

Page 189: ...__________ U ______________ U ______________ U Temp Basal Presets Name ________________________________________ ________________________________________ ________________________________________ ______...

Page 190: ..._________________________________________________ _____________________________________________________________________________________________________________ ________________________________________...

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