OmniPod UST200 User Manual Download Page 4 | Manualshive

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OmniPod UST200 User Manual Download Page 4

© 2010 Insulet Corporation. All rights reserved.

OmniPod is a registered trademark of Insulet Corporation.

U.S. Patent No. 6,740,059.

FreeStyle is a registered trademark of Abbott Laboratories.

NovoLog is a registered trademark of Novo Nordisk A/S. Humalog is a registered trademark of Eli Lilly and Company. Apidra is a registered
trademark of Sanofi Aventis. Windows is a registered trademark of Microsoft Corporation.

13705-AW Rev E

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Summary of Contents for UST200

Page 1: ...User Guide MyOmniPod com...

Page 2: ...EmailAddress Script Name Dose Frequency OmniPodSystemStartDate __________________________ PDMModel UST200 SerialNumber _________________ EmergencyServices Dial911 USAonly notavailableinallcommunities...

Page 3: ...User Guide Model UST200...

Page 4: ...ation U S PatentNo 6 740 059 FreeStyleisaregisteredtrademarkofAbbottLaboratories NovoLogisaregisteredtrademarkofNovoNordiskA S HumalogisaregisteredtrademarkofEliLillyandCompany Apidraisaregistered tra...

Page 5: ...lus calculation 3 Referencefoodlibraryandcarbpresets 3 Recordkeeping 3 PersonalizingyourSystem 3 The Pod 4 The Personal Diabetes Manager 4 ButtonsthatprogramandcontroltheOmniPodSystem 5 Primaryscreens...

Page 6: ...activetemporarybasalpreset 26 Change rename ordeleteatemporarybasalpreset 26 Maximum Basal Rate 28 Whatisthemaximumbasalrate 28 Changethemaximumbasalrate 28 4 Understanding and Delivering Bolus Doses...

Page 7: ...m Setup Menu 60 Reset the Date or Time 60 Resetthetime 60 Resetthedate 61 Change Bolus and Basal Settings 61 Bolus calcs 62 Ratios factors targets 64 Tempbasal 65 Extended 65 Bolusincrement 65 Maxbolu...

Page 8: ...us Calculator 92 Entering Blood Glucose Readings Manually 93 Editing Tags 93 Low and High Blood Glucose Readings 95 Lowreadings 95 Highreadings 95 Important Health Related Information 96 8 Understandi...

Page 9: ...n 129 Failure During Pod Deactivation 131 Failure During Request for Status 132 Failure During Bolus Cancellation 133 Failure During a Hazard Alarm 135 Appendices 136 Pod Care and Maintenance 136 Stor...

Page 10: ...tic Compatibility 149 Customer Bill of Rights 153 MissionStatement 153 ScopeofServices 153 Compliance 153 SupplyShipment 153 Inquiries 153 Customer sBillofRightsandResponsibilities 153 Limited Warrant...

Page 11: ...instructions DonotusetheintegratedFreeStyle BloodGlucoseMonitoring Systemfor Testingonnewborns Testingarterialblood Diagnosingoforscreeningfordiabetesmellitus USFederallawrestrictsthisdevicetosalebyor...

Page 12: ...ersonalDiabetes Manager PDM duringsetup seeChapter2 GettingStarted IfyouareunabletousetheSystemaccordingto instructions youmaybeputtingyourhealthand safetyatrisk Talkwithyourhealthcareproviderif youha...

Page 13: ...1 3455 WhencallingfromoutsidetheUnitedStates 781 457 5098 CustomerCareFax 877 467 8538 Website MyOmniPod com YourRole SafelyUsingtheOmniPodSystem Yourhealthcareproviderwillgiveyouallthetoolsandtrainin...

Page 14: ...PDM suchasthe Home Powerbutton Icon AnimageonthePDMscreenthatindi catesamenuoptionoritemofinforma tion Atableofscreeniconsappearsinthe Appendices Softkeys Arowofthreeunlabeledbuttonsonthe PDMwhoselabe...

Page 15: ...y andeaseofuse Continuousinsulindeliverymostcloselymimicstheinsulin releaseofahealthypancreas Sincethelandmark10 year DiabetesControlandComplicationsTrial DCCT thelong termhealthbenefitsofmaintainingn...

Page 16: ...ngthePodtothePDM Youwearthe Podcomfortablyanddiscreetlyunderyourclothes Youcancarry thePDMseparatelyinabackpack briefcase orpurse Withthe OmniPodInsulinManagementSystem youdon thavetoworry aboutsnaggi...

Page 17: ...rbpresets Presetscontainthegramsofcarbohy drateinthefooditemormeal Nexttimeyoueatthissamefood youdon thavetocountthecarbs justselectyourcarbpreset andtheSystemdoesthecalculatingforyou TheSystemstores...

Page 18: ...Aid ThePersonalDiabetesManager AllPodoperationsareprogrammedandcontrolledthroughthe palm sizedPersonalDiabetesManager PDM Figure1 2 Top Bottom Needle cap Viewing window Fill port Figure 1 1 Adhesive b...

Page 19: ...ionsdependonthe menuorscreenyouareviewing Thelabel appearsonthescreendirectlyabovethephys icalbuttonyoupress Select Save andBack arejustthreeexamplesofthesoftkeylabels onyourPDM Button Action UserInfo...

Page 20: ...eendisplays Time date andresultoflastbloodglucosecheckedor enteredmanually Time date andtotalamountoflastbolusdelivered Nameandrateofactivebasalprogramortempbasal program Extbolus theamountofinsulin a...

Page 21: ...nutosuspend cancel orresumeinsulin deliveryprograms SafetyFeatures TheOmniPodSystem sstate of the artdesignincludesthelatest safetytechnology Itsbuilt insafetyfeaturesinclude Automaticpriming safetych...

Page 22: ...ngeofalerts andalarmstotellyouthatyourattentionisneeded ortowarn youofhazardoussituations SeeChapter6 UsingthePersonalDiabetesManager fora descriptionofalertsandremindersandhowtosetthem See Chapter10...

Page 23: ...minadvance youwillgetmore outofyourtrainingsessions AfteryouunpacktheStarterKit usethe Contents listtomake sureyouhaveeverything Thencompletethewarrantycardand promptlymailittous Returningthecardallow...

Page 24: ...rtmentlatchandliftingupward Figure2 1 Nospecialtoolsarenecessary 2 Inserttwo 2 newAAAalkalinebatteriesintothecompart ment 3 Replacethebatterydoor 4 TurnthePDMface up ThePDMhasbeguntopoweron automatica...

Page 25: ...epreviousscreen TheWizard sWelcomescreen Figure2 3 getsyoustarted Press NexttobeginsettingupyourPDM Setdateandtime 1 UsetheUp DownControllerbuttonstoincreaseor decreasethetime Ifyouprefera24 hourclock...

Page 26: ...asalrate ChooseU hrtoshow temporarybasalratesinunitsperhour OrchooseOfftoturn offthetemporarybasalfeature Fordetailsaboutsettingtem porarybasals seeChapter3 UnderstandingandAdjusting BasalRates Enterb...

Page 27: ...Controllerbuttonstoenterthe cor rectabove valueorcorrectionthreshold theBGvalue abovewhichyouwantthePDMtosuggestacorrection bolus thenpressNext f Whenyouhavefinishedenteringsegments pressDone 4 Toseet...

Page 28: ...selectthesegmentyouwishtochangeandpressEdit Youcandefinecorrectionfactorsforupto4timesegments Toenteradditionalcorrectionfactors choose addnew then a PressNew b Enterastarttimeforthesegment thenpress...

Page 29: ...s orchoose Unitsforunitsofinsulin To turnofftheextendedbolusfeature chooseOff Thenpress Next Setlowreservoiralert 1 Choosethelevelofinsulininthereservoiratwhichthe PDMshouldgiveyouanalarm Choosefrom10...

Page 30: ...ningoftheSetup Wizard YoumaywanttoadjustthePDMscreentime out andbacklighttime out Formoreinformationon howtodothis seeChapter6 UsingthePersonal DiabetesManager UsetheformattheendofthisUserGuidetowrite...

Page 31: ...ersonmayneedtodelivera higherrateofinsulinduringtheearlymorningandalowerrate duringthelateevening Abasalprogramdescribestheamount ofinsulintobedeliveredduringanentire24 hourperiod Abasalprogramcontain...

Page 32: ...salprogram ThePersonalDiabetesManagercanstoreupto7differentbasal programs Eachprogramcancontain24rates programmedin half hourincrements Onceyouenterabasalprogramintothe PDM youonlyneedtopressafewbutto...

Page 33: ...rtheentire24 hourprogram pressDoneandcontinuewithstep7 Or toaddbasalsegmentsandrates forexample ahigher basalratebetween8 00amand3 00pm a Chooseanexistingbasalsegment thenpressEdit Or choose addnew th...

Page 34: ...eforeachbasalprogram upto7 youwanttocreate Enableanexistingbasalprogram 1 OntheHomescreen usetheUp DownControllerbuttons tochooseSettings thenpressSelect 2 ChooseBasalprograms thenpressSelect Basalrat...

Page 35: ...t Toviewthesegmentsofthebasalprogram 1 ChooseView thenpressSelect Figure3 8 Toeditoraddasegmentorrateinthebasalprogram 1 ChooseEdit thenpressSelect Adiamondicon appearsnexttotheprogramthat isactive Yo...

Page 36: ...rthecharac tersthatspelloutthenewnameyouwant Pressthemiddle softkey labeledwiththerightarrow tomovetheunder scoretothenextcharacter thenpressSave Tocopyabasalprogram 1 Afterchoosingaprogramfromthelist...

Page 37: ...changethataffectsbloodglucoseisanexampleofpredictable change Toeasilyhandlepredictable short termchanges you can preset atemporarybasalrate soitisreadywheneveryou needit ThePDMcanrememberupto7temporar...

Page 38: ...hePodbeepstoindicatethatthetemporarybasal rateisrunning Cancelaone timetemporarybasalrate 1 OntheHomescreen usetheUp DownControllerbuttons tochooseSuspend cancel thenpressSelect 2 ChooseCanceltempbasa...

Page 39: ...ownController buttonstoscrollthrough thelistofcharacters Anup and down arrowsymbolon thescreenindicatesthecharacteryouarechanging b Pressthemiddlesoftkeytomovetheunderscoretothe nextcharacter c Entere...

Page 40: ...activetemporarybasalpreset 1 OntheHomescreen usetheUp DownControllerbuttons tochooseSuspend cancel thenpressSelect 2 ChooseCanceltempbasal thenpressSelect 3 PressConfirmtocanceltheactivelyrunningtempo...

Page 41: ...et then pressNext 3 Enteranewdurationforthepreset thenpressSave 4 PressDone Torenameatemporarybasalpreset 1 ChooseRename thenpressSelect 2 PresstheUp DownControllerbuttonstoenterthecharac tersthatspel...

Page 42: ...rates Youandyourhealthcareproviderwillenteraninitialmaximum basalrateintoyourPDMduringthesetupprocess seeChapter 2 GettingStarted Youcanchangeitlaterasyoufine tuneyour Systemsettingsorwhen yourneedsch...

Page 43: ...lucoselevel Yourinsulin to carbohydrateratio Yourcorrectionfactor Yourtargetbloodglucose Theamountofinsulinonboard activeinsulin Yourcorrectionthreshold theBGlevelabovewhichyou wouldliketotakeinsulint...

Page 44: ...liveranother extendedbolus However youcandeliveranormalboluswhile anextendedbolusisactive SuggestedBolusCalculator ThesuggestedboluscalculatorletstheOmniPodSystemrecom mendyourbolusbasedonyourpersonal...

Page 45: ...rthecarbohy dratesyouenterintotheSystem Insulinonboard IOB IOBistheamountofinsulinstillworking inyourbodyfrompreviouscorrectionboluses Theamountof timeinsulinremains onboard or active dependsonwhatyou...

Page 46: ...ucoseresultreads HIGH or LOW thesuggestedboluscalculatorwillbe disabled Ifyouuseaseparatebloodglucosemeter notthe PersonalDiabetesManager PDM youwillneedto enteryourbloodglucosemanually Onthe Home scr...

Page 47: ...previouslyentered see CarbPresets laterinthischapter thenpressSelect b PressEntertoacceptthesuggestedbolus Figure4 4 OrpresstheUserInfo Supportbuttontoviewcalculation informationusedforthissuggestedbo...

Page 48: ...osereminder 4 PressConfirmtobeginthebolusdelivery DeliveranExtendedBolus TheextendedbolusfeatureletstheOmniPodSystemdeliver some orno insulinnowandtheremainderoveraperiodof timeyouchoose Deliveranexte...

Page 49: ...InFigure4 8youcanseeadetailoftheextended bolus 4 IfthebloodglucoseremindersfeatureisturnedOn you cannowsetabloodglucosereminder 5 PressConfirmtobeginthebolusdelivery IfyouhavesettheExtendedbolusoption...

Page 50: ...alreadyon Anon screenmessageappearsaslongasa normalbolusisbeingdelivered Figure4 9 Asasafetyfeature thecorrectionbolusisalways deliveredfirstandcannotbeextended Onlythe mealboluscanbeextended Forexamp...

Page 51: ...npressSelect 2 ChoosePresets thenpressSelect 3 ChooseBoluspresets thenpressSelect 4 Choose addnew thenpressNew 5 TousetheOmniPodSystem sdefaultnamingsystem simply pressNext Thedefaultnamingsystemautom...

Page 52: ...aximum bolusyouenteredduringsetup thenpressNext 7 Reviewtheboluspresetnameandamount pressSaveto acceptit Enableanexistingboluspreset 1 OntheHomescreen usetheUp DownControllerbuttons tochooseBolus then...

Page 53: ...screen Formoredetails see CancelActiveBoluses earlierinthis chapter CarbPresets Carbpresetsarefavoritefooditems snacks ormealsthatyoueat frequently Afteryouentertheseitems youcanquicklyselect onewhene...

Page 54: ...xtaftereachentry 9 PressSavetoaddthepresettothecategory Changeoreditacarbpreset 1 OntheHomescreen usetheUp DownControllerbuttons tochooseSettings thenpressSelect 2 ChoosePresets thenpressSelect 3 Choo...

Page 55: ...echaracters whichisablank 4 Enterthegramsofcarbohydrateinthemeal thenpressNext 5 Ifyouwant enterthegramsoffiber fat andproteininthe meal andthetotalcalories PressNextaftereachentry 6 PressSavetoupdate...

Page 56: ...e AgriculturalResearchService in2004 Accessthereferencefoodlibrary 1 OntheHomescreen usetheUp DownControllerbuttons tochooseFoodlibrary thenpressSelect Thescreendisplaysalistofmainfoodcategories Figur...

Page 57: ...siblegerms DoNOTuseaPodifyouaresensitivetoorhaveallergiesto acrylicadhesivesorhavefragileoreasilydamagedskin CheckoftentomakesurethePodandsoftcannulaare securelyattachedandinplace Alooseordislodgedcan...

Page 58: ...5 1 thenpressSelect 3 PressConfirm Figure5 2 todeactivatethecurrentPod NEVERuseinsulinthatiscloudy itmaybeoldorinac tive Failuretouserapid actingU 100insulin orusing insulinthatisoldorinactive maylead...

Page 59: ...eadhesivetapefromyourskin andremovetheentirePod Figure5 5 b Usesoapandwatertoremoveanyadhesivethatremains ontheskinor ifnecessary useanadhesiveremover c DiscardtheusedPodaccordingtolocalwastedisposal...

Page 60: ...elpyoudeterminethecorrectamount 5 Drawairintothesyringeuptotheamountofinsulinyou want 6 Inserttheneedleintotheinsulinvialandinjecttheair This makesiteasiertowithdrawinsulinfromthevial BeforefillingaPo...

Page 61: ...movetheneedlefromtheinsulinfillport Theportisself sealing insulinwillnotleakaftertheneedleisremoved Avoidusinginsulinfrommorethanonevial whichmayintroduceairintothesyringe Figure 5 9 Figure 5 10 Toens...

Page 62: ...utsidetheUnitedStates 781 457 5098 14 TheSystemperformsaseriesofsafetychecksandautomati callyprimesthePod Figure5 12 Oncecomplete thePDM beeps lettingyouknowthattheprimingandsafetychecks weresuccessfu...

Page 63: ...thefollowingpage Avoidsiteswherebelts waistbands ortightclothing mayrubagainst disturb ordislodgethePod Also avoidsiteswherethePodwillbeaffectedbyfoldsof skin ChangethesiteeachtimeyouapplyanewPod A ne...

Page 64: ...thsoapandwater 2 Usesoaptowashtheinfusionsite 3 Drythesitewithacleantowel 4 Useanalcoholprepswabtodisinfecttheinfusionsite Startat thecenterofthesiteandgentlyruboutwardinacircular motion 5 Letthesitea...

Page 65: ...p afewdropsof insulinshouldbevisibleattheendoftheneedle Figure 5 15 Figure 5 16 ForthePodtoworkbest applyit 1 Crosswiseorataslightangleonyourabdo men hip upperback orbuttocks seeA 2 Upanddownorataslig...

Page 66: ...rt Figure5 18 Theadhesiveisdesignedforone timeuse Once removed aPodcannotbereapplied Figure 5 17 IfyouareapplyingaPodinaplacethatdoesnothave alotoffattytissueorisverylean pinchtheskin aroundthePod Fig...

Page 67: ...allviewing windowonthePod Youwillhearaclickwhenthecannulainserts Figure 5 20 Figure 5 21 Checktheinfusionsiteafterinsertiontoensure thatthecannulawasproperlyinserted Itisalsoa goodideatocheckyourblood...

Page 68: ...eHomescreen pressStatus ThePDMautomaticallychecksthestatusofthePod ThePDM thendisplaysthecurrentreservoirvolume PDMbatterylevel lastbloodglucose lastbolusdose activebasalprogram andany alarmconditions...

Page 69: ...rmtoconfirmthatyouwanttohaltallinsulin delivery basalandbolus ThePDMbeepsandanon screen messageletsyouknowthatinsulindeliveryisindeedsus pended Figure5 24 ThePodbeepsevery15minutesuntiltheendofthesusp...

Page 70: ...on Ifyouareunsurewhethertouseaspecificsite askyour healthcareprovider Atleastonceaday usethePod sviewingwindowtocheck thesiteforsignsofinfectionandtoconfirmthatthesoftcan nulaissecurelyinplace Beaware...

Page 71: ...eyour Podpriortousinghottubs whirlpools orsaunas TheseconditionscouldexposethePodtoextreme temperaturesandmayalsoaffecttheinsulininside thePod Remembertocheckyourbloodglucoselevelsfrequently beforeand...

Page 72: ...einformationobtainedisthendisplayedinthestatus screen whichshowstheSystem scurrentoperatingstatus TheStatusscreen Figure6 1 displays Time date andresultoflastbloodglucosecheckedor enteredmanually Time...

Page 73: ...YoucanadjustthePDMsettingstomeetyourindividualneeds 1 FromtheStatusscreens pressHome 2 UsetheUp DownControllerbuttonstochooseSettings thenpressSelect 3 ChooseSystemsetup thenpressSelect 4 Chooseanopt...

Page 74: ...Occasionally youneedtochangedateandtimesettings for example toadjustfordaylightsavingstimeorafterresettingthe PDM Asasafetyfeature youcanchangedateandtimesettings onlywhenthePodisdeactivatedorwheninsu...

Page 75: ...rmat ChangeBolusandBasalSettings Youandyourhealthcareproviderenteredinitialbolusandbasal SystemsettingsusingtheSetupWizard UsingtheSystemsetup menu youcaneditalltheOmniPodSystembolusandbasalset tingsa...

Page 76: ...e segment thenpressEdit UsetheUp DownController buttonstochooseanewstarttime endtime targetBG value andcorrect abovevalue correctionthreshold Press Nextaftereachentry b Toaddasegment choose addnew the...

Page 77: ...egments press Done thenSave 4 Correctionfactor Youcaneditexistingtimesegmentsand addsegments uptoatotaloffour a Toeditanexistingcorrectionfactortimesegment choose thesegment thenpressEdit UsetheUp Dow...

Page 78: ...thenpressNew UsetheUp DownControllerbuttonstochooseastart time endtime targetBGvalue andcorrect abovevalue correctionthreshold PressNextaftereachentry c Whenyouhavecompletedallthetimesegmentsyou want...

Page 79: ...Insulinaction duration UsetheUp DownController buttonstochooseadurationofinsulinaction thenpress Enter Tempbasal Choose U hr orOfftosetthemodefortemporarybasal ratesandpresets thenpressSelect Extended...

Page 80: ...hePod Choosea levelfrom10to50units in5 unitincrements Thedefaultsetting is10units Auto off AlertsyouifthePDMdoesnotreceiveaPodstatus withinapredefinedperiodoftime ObtainPodstatusbypress ingandholdingt...

Page 81: ...seOnorOff ThedefaultsettingisOn Customalerts Displaystextremindersthatyouenter attimes thatyouselect YoucanchoosetoreceiveanalertDaily One timeonly orOff Youcanchangeordeletethesecustomalerts atanytim...

Page 82: ...youwishtodelete then pressEdit b ChooseDeletethenpressSelect c PressDeletetoremovethebolusreminder 7 ForCustomalerts UsetheUp DownControllerbuttonstochoose add new thenpressNew TousetheOmniPodSystem s...

Page 83: ...istory ManageBGtagslist BGsound OnorOff 1 OntheHomescreen usetheUp DownControllerbuttons tochooseSettings thenpressSelect 2 ChooseSystemsetup thenpressSelect 3 ChooseBGmeter thenpressSelect 4 Chooseth...

Page 84: ...how ifitismarkedashidden orHide Tagsyouchoosetoshowwillbecheckmarked hiddenones willnotbe 2 Toaddacustomtag choose addnew attheendofthelist ofcustomtags thenpressNew IntheEditnamescreen either a Press...

Page 85: ...backlightand causesthescreentodimwhenyouhavenotuseditwithinthe timeintervalthatyouset Setatthelowestsettingtomaximize batterylife SetPDMoptions 1 OntheHomescreen usetheUp DownControllerbuttons tochoos...

Page 86: ...ainbypressinganybutton ThePDMwillignoretheusualcommandandrelightthescreen SetDiagnosticFunctions TheDiagnosticsscreenallowsyoutoinstantlyconfirmhowthe Systemisworkingortocompletelyupdatesettingsentere...

Page 87: ...gpage PressConfirmtoresetthePDM IfthePodisstillactive youwillbeunabletoresetthePDM Figure6 15onthefollowingpage PressOKtoreturntothe Diagnosticsmenu IfthePDMfailstobeep immediatelycallCustomer Careat8...

Page 88: ...ommunicatingwiththePod WhenyouusethePDMtocommunicatewiththePod holdthe PDMwithin24 61cm ofthePod IfyouwearthePodonyour abdomen holdingthePDMinyourhandswhenpressingthe buttonsshouldbecloseenough Watera...

Page 89: ...p tionsareeasytoresolve seeChapter11 Communication Failures DonotstoreorleavethePDMwhereitmaybe exposedtoextremetemperatures suchasinsidea car Extremeheatorcoldcancausethedeviceto malfunction Neveratt...

Page 90: ...estto testonyourfingers Bloodfromthefingertipsmayshowthese changessoonerthanbloodfromothersites Youmayalsowanttotestforlowbloodglucose Whenyoufeelsymptomssuchasweakness sweating nervousness headache o...

Page 91: ...erbloodglucosetestsstripsinany way OnlyuseFreeStyle teststripsandFreeStyle control solutionwiththeOmniPodSystem Usingother brandsofteststripsandcontrolsolutionswiththe OmniPodSystemcanproduceinaccurat...

Page 92: ...provideradvisesyoutodoso Checkthatthemeterandteststripsareworking Acontrolsolutiontestfollowsthesameprocedureasablood glucosetest exceptthatyouuseasampleofcontrolsolution insteadofadropofblood See Per...

Page 93: ...hePDM MalfunctionoftheOmniPodSystem Controlsolutiontestdoneoutside59 to104 F 15 to40 C Ifyourcontrolsolutiontestresultscontinuetofalloutsidethe rangeprintedontheteststripvial 1 TheOmniPodSystemmaynotb...

Page 94: ...umberonthescreen BereadytoadjustthecodeonthePDMtomatchthe codenumberontheteststripvial Figure7 5 Figure 7 3 Top toinsert into meter FreeStyle test strip Bottom edges for blood sample Ifyouneedtoadjust...

Page 95: ...cles Figure 7 7 IfBGsoundissettoOn thePDMbeepswhenthetest stripisfull Ifyoudonotapplythesamplewithin10seconds thestrip portlightturnsoff Toturnitonagain pressLight FromsomePDMscreens youcannotaccessth...

Page 96: ...esameway c PressOK 7 Ifyoudonotwanttomarkthetestasacontrolsolutiontest pressNextinsteadofTag 8 Comparethecontrolsolutiontestresulttotherangeprinted ontheteststripviallabel Iftheresultdoesnotfallwithin...

Page 97: ...artsoftheFreeStyle lancingdevice Besuretodiscardusedteststrips Youcanonlyuse teststripsonce Toensureaccurateresults washyourhandsandthe testsite forexample yourforearm withsoapand water Donotleaveanyc...

Page 98: ...ceintothecupmay cockthedevice whichisfine 3 Holdthelancetfirmlyinplacewithonehand Withyourother hand twistofftheroundedtop Figure7 13 4 Replacethecapuntilitsnapsorclicksintoplace Figure7 14 Becarefuln...

Page 99: ...Youmayhavealreadycockedthehandleinstep2 Thisis okay Youarenowreadytoperformabloodglucosetest Insertthebloodglucoseteststrip 1 Insertanewbloodglucoseteststripintotheteststripport untilitstops Thetestst...

Page 100: ...tmatchthecodeonthesideof thevial Tochangethecodenumber presstheUp DownController buttonsuntilthenumbermatchesthenumberonyourvial The numbersarebetween1and50 Ifyoudonotadjustthecodenumberwithin2seconds...

Page 101: ...ereleasebutton thenputdownthelancing device 5 Gentlysqueezeyourfinger ifneeded untilablooddropthe sizeofapinheadforms IfyouneedtoadjustthecodenumberafterthePDM hasmovedtothenextscreen justpresstheUp D...

Page 102: ...3 Holdthelancingdevice withtheclearcap againstthetopof yourtestsite 4 Depressthereleasebutton Donotliftupthelancingdevice instead continuetoholditandgraduallyincreasepressure forseveralseconds Figure...

Page 103: ...otapplythesamplewithin10seconds thestrip portlightturnsoff Toturnitonagain pressLight Useonlyoneedgeofthebloodglucoseteststrippertest Do notapplybloodtobothedges Figure7 28 Onlyusestrips once Discardu...

Page 104: ...trip portlightturnsoffwhenthebloodsampleis accepted 3 Thereadingiscompletewhenyouhear2beeps ifBGsound isturnedOn andthePDMshowsyourreadingonthescreen Figure7 31 Thetimethetesttakesdependsonyourbloodgl...

Page 105: ...TagsList in Chapter6 UsingthePersonalDiabetesManager b PressOKtoreturntothereadingscreen Figure7 31on thepreviouspage thenpressNext 5 Ifyoudonotwanttomarkthetest pressNextinsteadofTag 6 Removethetests...

Page 106: ...toreturntotheStatusscreentoseethemost recentBGresult TheBGresult eitherfromthePDMorfrommanualentry is storedintheSystem shistory whethersuggestedboluscalcula toristurnedOnorOff See BloodGlucoseRecords...

Page 107: ...oreturntotheMoreactionsmenuwithout savingthereading EditingTags Within2hoursofabloodglucosereading youcanremoveor changeatagoraddone However youcannotalteraControltag 1 OntheHomescreen usetheUp DownCo...

Page 108: ...Toremoveaselectedtag highlightitandpressClear The softkeychangesfromSelecttoClearwhenyouhighlight thetag 6 PressOK toreturntothelistofreadings IfnoBGreadingshavebeenenteredintothePDMwithinthe past2ho...

Page 109: ...readingbuthavenosymp tomsoflowbloodglucose retestwithanewstrip Ifyoustillget a LOWTreatyourlowBG reading followyourhealthcarepro vider srecommendationtotreathypoglycemia Highreadings Ifyourreadingisab...

Page 110: ...instructionsdescribedinthisUserGuide callyourhealthcare providerimmediately Bloodcirculationisdifferentbetweenthefingerorpalm at thebaseofthethumb andothertestsitesliketheforearm upperarm hand thigh...

Page 111: ...ollerbuttonstohighlighttherecord then presstheUserInfo Supportbuttontoviewdetails aboutthatrecord Therecordforthisitemhasbeen lost IfthePDMcannolongercommunicatewithan activePod thenyoumustactivateane...

Page 112: ...1 OntheHomescreen usetheUp DownControllerbuttons tochooseMyrecords thenpressSelect 2 ChooseInsulindelivery thenpressSelect Figure8 1 ThePDMdisplaysasummaryoftoday sinformation includingtotalbolusesdel...

Page 113: ...uetoaPodalarm Poddeacti vation orusercancellation Thescreenshowstheamountof thebolusorbasalthatremainedundelivered 4 PressDaytoreturntodates 5 Toreviewyourbolushistorybyday pressBolus Thedisplayindica...

Page 114: ...henpressSelect 2 ChooseBGhistory thenpressSelect ThePDMdisplaysthecurrent daytrendsfirst Figure8 5 including Numberofdaysandnumberofbloodglucose readings n Averagebloodglucose AvgBG Lowestandhighestbl...

Page 115: ...4 PressClosetoreturntotheListview 5 PressGraphtoseeagraphofthedata Figure8 9 Viewmultiple daytrends 1 OntheHomescreen usetheUp DownControllerbuttons tochooseMyrecords thenpressSelect 2 ChooseBGhistory...

Page 116: ...rbuttons tochooseMyrecords thenpressSelect 2 ChooseAlarmhistory thenpressSelect ThePDMdisplaysthedate time andtypeofeachalarm Figure8 12 3 PresstheUp DownControllerbuttonstoseeadditional screens 4 Cho...

Page 117: ...ollerbuttonstoscroll throughthelistofinformationonthescreen PressDayto usetheUp DownControllerfordates UserInformation Support Youoryourhealthcareprovidermayhaveenteredpersonal contactinformationdurin...

Page 118: ...Entereachcharacteroneatatime Forexample ifyouwant toenteryouraddress youmightenter5 6 5 space M a i n space S t period Ablankcharacterorspaceisthefirst andlastoptioninthescrollingmenu Foryourhealthcar...

Page 119: ...esmanagement Beingactivelyinvolvedinyourtreatment Checkingyourbloodglucoselevelsfrequently Washingyourhandsanddisinfectinginfusionsitestoreduce thepossibilityofinfection Beingawareofthesignsofhypoglyc...

Page 120: ...Before during andafterexercise Asdirectedbyyourhealthcareprovider Inspecttheinfusionsitedaily Atleastonceaday usethePod sviewingwindowtoinspectthe infusionsite Checkthesiteforsignsofinfection suchasp...

Page 121: ...ncingdeviceandlancets Glucosetabletsoranotherfast actingsourceof carbohydrate Alcoholprepswabs Acopyoftheletterfromyourhealthcarepro viderforairlinesecurity see Minimizeairport securitydelays laterint...

Page 122: ...inanunfamiliarplace Iftravelingbyair besuretopack yoursuppliesinyourcarry onluggage Whenpackingfortravel takemoresuppliesthanyouthinkyou llneed Besuretoinclude Diabetesemergencykitpackedinyourcarry on...

Page 123: ...upplies clearlymarkedwith theiroriginalpharmacylabels Ifthesecuritydetectorgoesoff tellthesecurityscreenerthatyou havediabetesandwearaninsulinPod pump Keepsuppliesaccessible Onairplanesandtrains keept...

Page 124: ...24 hour CustomerCarelineat800 591 3455 fromoutsidetheUnited States 781 457 5098 Hypoglycemia lowbloodglucose HypoglycemiacanoccurevenwhenaPodisworkingproperly Neverignorethesignsoflowbloodglucose noma...

Page 125: ...oviderforguidanceinanyandall areaslistedabove Totreathypoglycemia lowbloodglucose Anytimeyourbloodglucoseislow treatitimmediately Checkit every15minuteswhileyouaretreating tomakesureyoudon t overtreat...

Page 126: ...hypoglycemia lowbloodglucose onthenextpage Howmuchis15gramsofcarbohydrate Examplesoffast actingfoods Three5 gramglucosetablets orfour4 gramtablets 4ounces 118milliliters ofappleororangejuice 6Lifesave...

Page 127: ...dtiming DoNOTovercorrectforpost meal glucoselevels Checkcarbintake Consulthealthcareproviderfor guidance Bolustoolarge Possiblecauseoflow Suggestedaction Incorrecttarget bloodglucoselevels Consultheal...

Page 128: ...dtreatas necessary Consultyourhealthcareprovider aboutadjustingyourbasalpro gramsorusingatemporary temp basalrate Lowcarbohydrate intakepriorto activity Consumecarbohydratebefore activity especiallyif...

Page 129: ...arepresent followyourhealthcare provider sguidelines 3 Ifketonesarenotpresent takeacorrectionbolusaspre scribedbyyourhealthcareprovider 4 Checkbloodglucoseagainafter2hours 5 Ifbloodglucoselevelshaveno...

Page 130: ...ovider Dislodgedcannula DeactivateandremoveusedPod ApplyanewPodinadifferent location Avoidsitesnearawaistband belt orotherareaswherefric tionmaydislodgethecannula Possiblecauseofhigh Suggestedaction E...

Page 131: ...ketonespresent beforeexercise DoNOTexercisewhenketonesare present Bloodglucoseincreases withexercisewhenketonesare present Consulthealthcareproviderfor guidance Infectionorillness See Sickdays lateri...

Page 132: ...oavoidDKAisbychecking yourbloodglucoseatleast4 6timesaday Routinechecks allowyoutoidentifyandtreathighbloodglucosebeforeDKA develops TotreatDKA Onceyouhavebeguntreatmentforhighbloodglucose checkforket...

Page 133: ...ul recordsofresults Checkforketoneswhenbloodglucoseis250mg dLor higher Followyourhealthcareprovider sguidelinesfortakingaddi tionalinsulinonsickdays Drinkplentyofnoncaffeinatedfluidstopreventdehydrati...

Page 134: ...linsulinthatwasmissedwhilethe Podwasremoved Yourhealthcareprovidercanhelpyoupre pareforthesesituations Ifpossible avoidwastingPodsbyplanningremoval timesthatcoincidewithascheduledPodreplace ment ThePo...

Page 135: ...ntiallyserious condition theSystemsoundsanalarmanddisplaysanon screenmessage Themessagehasinstructionsfortakingcareof thealarmcondition Alarmconditionsareeasytohandle They arenotaproblemifyouattendtot...

Page 136: ...tdoesnotwork ortheerrorpersists call CustomerCareat800 591 3455 fromoutsidetheUnitedStates 781 457 5098 MeterError2 Seeusermanualfor furtherinstructions Problemwiththeteststrip Problemwiththemeter Ver...

Page 137: ...rorpersists call CustomerCareat800 591 3455 fromoutsidetheUnitedStates 781 457 5098 MeterError4 Seeusermanualfor furtherinstructions Problemwiththeteststrip Problemwiththemeter 1 Conductacontrolsoluti...

Page 138: ...hazardalarmsifyoudonot respondwithinacertaintimeperiod asnotedinthetable below Alarm Source BeepPattern Action Lowreservoir Replacepodsoon Thisisbasedonthevolume levelyouselected Pod and PDM 2setsofbe...

Page 139: ...etsofbeepseveryminutefor15minutes EscalatestoAuto offhazardalarmifnot acknowledgedwithin15minutes PressOKtoacknowledge Resetclock Stuckkeydetected CheckHomebuttonto resolve Fortechnicalsupport call 80...

Page 140: ...andalarms whentheyoccur ForahazardalarmcausedbyaPDMerroror Systemerrorthatdisplays Callcustomersupport removethePodandcall800 591 3455immediately forCustomerCare fromoutsidetheUnitedStates 781 457 509...

Page 141: ...etabonourWebsite MyOmniPod com Amongtheseresourcesareanonlinecopyofthis UserGuideandtheMyOmniPodSystemInformation form whichyouwillalsofindattheendofthis guide Alarm Source Action Emptyreservoir Insul...

Page 142: ...reat 800 591 3455 from outsidetheUnited States 781 457 5098 Checkbloodglucose Alarm Source Action PDMError Press Ok toresetclock PDM PressOKtoacknow ledge Resetclock Checkbloodglucose PDMError Memoryc...

Page 143: ...ToofarfromthePod Itmustbewithin24 61cm when youareenteringorchangingsettings Interruptedbyoutsideinterference Seethe OmniPod SystemFederalCommunicationsCommission FCC Notice ConcerningInterference int...

Page 144: ...catewiththePodagain Ifitcannotcommuni cate itdisplaysthesamescreenasinFigure11 2 then finallythe Communicationtimeout screen Figure11 3 PressOKtocheckthePodstatus b Ifthestatuscheckfails youwillseeFig...

Page 145: ...wereactivatingaPod theSystemreturnstothepre viousscreen whereyoucancontinueactivation Ifyou wereissuinganyothercommand theSystemreturnsto theStatusscreen whereyoucanreissuethecommand FailureDuringPodD...

Page 146: ...Waituntilyouseethe Podstatusnotavailable screen Figure11 10 OrpressSkiptoskipthecommunicationprocessandimme diatelybringupFigure11 10 Ifyouhaveanunconfirmedcorrectionboluswhenyou discardaPod thenthebo...

Page 147: ...DMtocancelabolus ifthePDMcannot sendyourinstructiontothePodwithinafewseconds itdisplays the Communicationerror screen Figure11 12 1 MovethePDMclosetothePod ThePDMtriestocommuni catewiththePodagain 2 I...

Page 148: ...thenfinallyasecond Bolus statusunknown screen Figure11 14 PressOKtocheck thePodstatusorpressDiscardtobeginthedeactivation process 4 IfatanypointinthisprocessthePDMcancommunicate againwiththePod youwi...

Page 149: ...nshutoff thealarmmanually 1 RemovethePodfromyourbodyifyouhavenotalready doneso 2 Presstheendofapapercliporsimilaritemstraightdowninto themanualalarmshut offport Figure11 17 onthetopside ofthePod Figur...

Page 150: ...ampcloth Oryoucanusemildsoapand water However donotusestrongdetergentsorsolvents They candamagethePod scasingorirritatetheinfusionsite PersonalDiabetesManagerCareandMaintenance Storage Whenyouarenotac...

Page 151: ...veicons ThePDMautomaticallyalertsyouwhenitsbatterypowergets low seeFigureA 1 Whenyouseethe LowPDMbattery alert pressOKtoturnoffthealert Replacethebatteriesassoonas youcan DoNOTuseIVPrepwipes alcoholwi...

Page 152: ...ntallyfallin Ifitbecomessub mergedinwater 1 DrytheoutsideofthePDMwithaclean lint freecloth 2 Openthebatterycompartment removethebatteriesand discardthem 3 Useaclean lint freeclothtogentlyabsorbanywate...

Page 153: ...ing 800 591 3455 fromoutsidetheUnitedStates 781 457 5098 Monday Friday 8 30am 8pmEasternTime Weuseestablished reliablecarrierstoinsurefast safedelivery Specialorovernight deliveryispossibletomostparts...

Page 154: ...et 25mg dL 25mg dL 50CF 0 5unitsreversecorrectionbolus subtractedfrommealbolus Mealboluscalculation Carbsentered insulin to carb I C ratio Exampleofmealbolus Carbsentered 45gramsofcarb Insulin to carb...

Page 155: ...Carbintake 45carbs Insulinonboard 0units Correctionbolus 150mg dL current 100mg dL target 50 50 50 CF 1unit Mealbolus 45 carbs 15 I Cratio 3units Suggestedbolusdose 1 correction 3 meal 0 IOB 4U Examp...

Page 156: ...iveinsulin issubtractedfirstfromacor rectionbolus ifany untilitiszero Atthatpoint theremain inginsulinonboardissubtractedfromthemealbolus Thecalculatedinsulinonboardisroundeduptothenearest 0 05U Areve...

Page 157: ...sein30 minuteincrements DefaultisOff Bloodglucosemetersound OnorOff DefaultisOn Suggestedboluscalculator OnorOff DefaultisOn TargetBGvalueand correctionthreshold 4timesegments 70to200mg dL in1mg dLinc...

Page 158: ...U 100 Alarmtype Audible Operatingrelativehumidityrange 20 85 noncondensing Storagerelativehumidityrange 20 85 noncondensing Operatingatmosphericpressure 700hPAto1060hPA Storageatmosphericpressure 700h...

Page 159: ...hangesintheflowrateoverthe stabilizationperiod ThemeasurementsweremadeusingaPod withabasalrateof1 0U hathighoperatingtemperature Flowrateerror Thefollowingtrumpetcurveshowstheaccuracyofthedelivery rat...

Page 160: ...Fto122 F 10 Cto50 C Operatingrelativehumidityrange 5 to90 noncondensing Storagerelativehumidityrange 5 to90 noncondensing Operatingatmosphericpressure 700hPAto1060hPA Storageatmosphericpressure 700hP...

Page 161: ...eordernumber Deviceserialnumber TypeBFmedicaldevice protectionfromelectricalshock Latexfree Non pyrogenic fluidpathwayonly NotMRI safe Watertightto25feetfor60minutes Keepdry Symbol Meaning Storagetemp...

Page 162: ...seharmfulinterferencetoradio communications Therearenoguaranteesthatinterferencewill notoccurinaparticularinstallation IftheOmniPodSystemdoes causeharmfulinterferencetoradioandtelevisionreception the...

Page 163: ...t medicalelectricalequipment Cablesandaccessoriesnotspecifiedwithintheinstructionsfor usearenotauthorized Usingothercablesand oraccessories mayadverselyimpactsafety performance andelectromagnetic comp...

Page 164: ...inallestablishmentsinclud ingdomesticestablishments ElectromagneticImmunity TheOmniPodSystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow Youshouldobservetheserequire mentsintheuseofth...

Page 165: ...rferencemayoccurinthevicinityofequipmentmarked withthefollowingsymbol Note1 At80MHzand800MHz thehigherfrequencyrangeapplies Note2 Theseguidelinesmaynotapplyinallsituations Electromagneticpropagationis...

Page 166: ...ers 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 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 Fortransmittersratedatamaximumoutpu...

Page 167: ...ons Ifyouhave anyquestionsorconcernsregardinganyofouractivities please contactusat1 800 591 3455 fromoutsidetheUnitedStates 781 457 5098 SupplyShipment InsuletCorporationcontactscustomerstoschedulequa...

Page 168: ...Askquestionsaboutanypartoftheplanofserviceorplanof carethatyoudonotunderstand 2 Usetheequipmentforthepurposeforwhichitwaspre scribed followinginstructionsprovidedforuse handling care safetyandcleanin...

Page 169: ...dtoobtain warrantyservice Exclusions ThisWarrantycoversonlytheoriginalpurchaserandcannotbetransferred withsale rentalorothertransferofthePDMtoanyotherpersonorentity THISWARRANTYDOESNOTAPPLYIFTHEPDMHAS...

Page 170: ...time excepttotheextentthatwehavemadeanyusesor disclosuresofyourMedicalInformationinrelianceonsuch authorization Torevokeapreviouslyissuedauthorization please sendyourrequestinwriting alongwithacopyoft...

Page 171: ...aw ofanysuchusesordisclosures PublicHealth WemaydiscloseyourMedicalInformationfor publichealthactivitiesandpurposestoapublichealthauthority thatispermittedbylawtocollectorreceivetheinformation Thedisc...

Page 172: ...boardthathasreviewedtheresearch proposalandestablishedprotocolstoensuretheprivacyofyour MedicalInformation CriminalActivity Consistentwithapplicablefederalandstate laws wemaydiscloseyourMedicalInforma...

Page 173: ...ludedonthatform Wewillrespondtoyourrequestinareasonableamountoftime Ifyourrequestishonored wemaychargeanominalfeefor photocopyingexpenses PleasecontactourPrivacyOfficerifyou havequestionsaboutaccessto...

Page 174: ...behandledorspecificationofanalternative addressorothermethodofcontact Wewillnotrequestan explanationfromyouastothebasisfortherequest Pleasemake thisrequestinwritingtoourPrivacyOfficer YouHavetheRightt...

Page 175: ...acy NoticeevenifwecollectedorreceivedtheMedicalInformation priortotheeffectivedateoftheRevisedHIPAA PrivacyNotice ThecurrentHIPAAPrivacyNoticeispostedonour Websitesat Insulet com MyOmniPod com Youcana...

Page 176: ...reatBritain 417CenterStreet Lewiston NY14092 716 754 4883 JuvenileDiabetesResearchFoundationInternational 120WallStreet NewYork NY10005 4001 800 533 2873 www jdf org MedicAlertFoundation Toordermedica...

Page 177: ...U hr Basalsegment timesegment Thetimeperiodduringwhichaspecificbasalrateisdelivered BGgoal Arangeofbloodglucoselevelsthatyouaretryingtoachievedur ingacertainperiodoftheday Forexample youmaywantone BGg...

Page 178: ...etes Harmfuleffectsofdiabetessuchasdamagetotheeyes kidney heart bloodvessels nervoussystem teethandgums feet and skin Correctionbolus Anamountofinsulintakentocompensateforhighbloodglucose levels TheOm...

Page 179: ...n varygreatlydependingonthetypeofinsulinyoutake Onlyuse rapid actinginsulinwiththeOmniPodInsulinManagement System Extendedbolus AfeatureoftheOmniPodSystemthatallowsamealbolusdoseto begivenoveranextend...

Page 180: ...nulaisinserted Insulin Ahormonethathelpsthebodyuseglucoseforenergy Thebeta cellsofahealthypancreasmakeinsulin Insulinonboard activeinsulin Theamountofinsulinthatisstill active inthebodyfromaprevi ousc...

Page 181: ...io Multipledailyinjections MDIs Introducinginsulinintothebodywithasyringeseveraltimesa day Occlusion Ablockageorinterruptionininsulindelivery Primebolus Anamountofinsulinusedtofillthecannula preparing...

Page 182: ...gs andinputs Thesettingsusedtocalculateasuggestedbolusare targetBG insulin to carbohydrate IC ratio correctionfactor CF anddurationofinsulinaction Theinputsusedtocalculateasug gestedbolusarecurrentBG...

Page 183: ...o off 66 BG reminder 66 confidence alerts 67 custom alerts 67 low reservoir 15 66 missed bolus 66 Pod expiration 66 American Diabetes Association 162 aseptic technique 43 56 163 automated cannula inse...

Page 184: ...lculator 30 34 140 142 bolus presets 37 39 163 cancel 39 change 39 create 37 delete 39 enable 38 rename 39 bolus reminder add 68 Bolus basal calcs menu 61 bright mode 5 71 buttons Home Power 5 Up Down...

Page 185: ...y basal program 22 correct above value Seecorrection threshold correction bolus 31 140 164 correction factor 14 29 63 65 164 correction threshold 29 62 64 164 create basal program 18 bolus preset 37 c...

Page 186: ...BG meter 121 123 exercise 114 119 expiration control solution 78 Pod 66 test strips 77 expiration alert 66 extended bolus 15 30 34 36 165 Extended option 65 extreme temperatures 75 F failure See comm...

Page 187: ...board IOB 29 31 140 142 166 insulin reservoir 59 insulin rapid acting vs long acting 118 insulin to carb IC ratio x 13 29 63 64 166 interference 148 International Association for Medical Assistance to...

Page 188: ...eb site xi one time temporary basal rate 23 cancel 24 enable 23 operating temperatures 75 144 146 options Bolus calcs 62 Extended 65 Max basal rate 65 Max bolus 65 Ratios factors targets 64 Temp basal...

Page 189: ...os factors targets option 64 65 record keeping 3 97 104 record screens 97 104 alarms 102 all 103 blood glucose 100 carbohydrates 102 combined records 103 insulin delivery 98 personal contact informati...

Page 190: ...Status screen 6 7 Status screens 58 59 storage temperature 144 146 stuck key advisory 125 suggested bolus calculator 3 12 30 34 92 168 examples 140 141 guidelines 142 supplies ordering 139 packing for...

Page 191: ...hanging18 22 25 27 38 39 time 11 60 time format See clock time segment See basal segment time zones 108 training 9 travel concerns 108 U Up Down Controller button 5 UserGuide symbols xii User Info Sup...

Page 192: ...calculator 12 00 AM to ________ ________to ________ ________to ________ ________to ________ Target BG _________ _________ _________ _________ Suggest correction when BG is above ___________ mg dL ___...

Page 193: ...hr or Bolus Presets Name ________________________________________ ________________________________________ ________________________________________ ________________________________________ ___________...

Page 194: ...in USA PDM imagery is for illustrative purposes only PDM screens may vary based on model or user settings Model UST200 13705 AW Rev E No strings attached Insulet Corporation 9 Oak Park Drive Bedford...

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