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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

Содержание mylife OmniPod

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Страница 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...

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Страница 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...

Страница 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...

Страница 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...

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Страница 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...

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Страница 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...

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Страница 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...

Страница 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...

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

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

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

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

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

Страница 190: ..._________________________________________________ _____________________________________________________________________________________________________________ ________________________________________...

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