CRISI Medical Systems RADIO2 Manual Injection monitoring system for anesthesia User Manual

CRISI Medical Systems Manual Injection monitoring system for anesthesia

User manual

1BDAnesthesiaSystemInstructionsforUseManualInjectingConfidence™
2ADDLIMITEDWARRANTYANDDISCLAIMERHEREThisdocumentcontainsconfidentialinformation.Nopartofthisdocumentmaybetransmitted,reproduced,used,ordisclosedoutsideofthereceivingorganizationwithoutthewrittenconsentofBectonDickinsonandCompany.“Intelliport”and“injectingconfidence”aretrademarksofCRISIMedicalSystems,Inc.BD,BDLogo,andLuer‐LokaretrademarksofBectonDickinsonandCompany.CaviWipes1andSuperSani‐Cloth,aretrademarksoftheirrespectivemanufacturers.ProtectedbyoneormoreofU.S.PatentNos.8,394,053,8,355,753,8,385,972,8,328,082.Otherpatentspending.©2014BectonDickinsonandCompany
3TableofContentsSECTIONIBACKGROUND.....................................................................................................................8Introduction..............................................................................................................................................8ProductDescription..................................................................................................................................8HowitWorks...........................................................................................................................................10IndicationsforUse..................................................................................................................................11IntendedUse...........................................................................................................................................11SECTIONIISAFETYPRECAUTIONS......................................................................................................12WarningsandPrecautions......................................................................................................................12General................................................................................................................................................12TabletcomputerTabletcomputerTabletcomputer...............................Error!Bookmarknotdefined.Tabletcomputer.................................................................................................................................13Intelliportdevice.................................................................................................................................14SECTIONIIIDESCRIPTIONOFANESTHESIASYSTEMCOMPONENTS.....................................................17SuppliesandEquipment.........................................................................................................................17Intelliport................................................................................................................................................17IntelliportSensor................................................................................................................................17IntelliportBase....................................................................................................................................18Recharger................................................................................................................................................19EncodedSyringes....................................................................................................................................19Tabletcomputer.....................................................................................................................................20SoftwareRunninginStandaloneMode..................................................................................................20AnesthesiaView..................................................................................................................................21NursingView.......................................................................................................................................23ButtonandMenuOptions..................................................................................................................24SoftwareRunninginEMR‐IntegratedMode...........................................................................................27SECTIONIVOPERATIONS...................................................................................................................30QuickGuide.............................................................................................................................................30PreparetheIntelliport........................................................................................................................30SetuptheTabletcomputer................................................................................................................30GiveIVinjectionsandViewMedicationAdministrations...................................................................31
4DetailedOperatingInstructions..............................................................................................................32PreparetheIntelliport........................................................................................................................32SetuptheTabletcomputer–PaperAnesthesiaRecord.....................................................................32GiveanIVinjectionUsingtheIntelliportDevice................................................................................37SpecialActivities.....................................................................................................................................39SettingUserPreferences....................................................................................................................39AddingAdditionalIntelliports.............................................................................................................39MedicationDeliverywithSyringesNotEncoded................................................................................40SpecifyingaDilutedorReconstitutedMedication.............................................................................41SpecifyingaMixedMedication(Cocktail)...........................................................................................42AddingManualInjection(forPaperAnesthesiaRecords)..................................................................43AddingInfusions(forPaperAnesthesiaRecords)...............................................................................43AddingaComment(forPaperAnesthesiaRecords)..........................................................................45TransferPatientsfromOneCareAreatoAnother.............................................................................45WorkingwithOrders...........................................................................................................................46RespondingtoMessages....................................................................................................................47ReviewingtheMedicationRecord(forPaperAnesthesiaRecords)..................................................48PrintingaReport(forPaperAnesthesiaRecords)..............................................................................49AddressPendingMedications(EMRIntegration)...............................................................................49DeactivateIntelliport,DisposeofIntelliportSensor,andPrepareIntelliportBaseforReuse...........50PowerDowntheTabletcomputer......................................................................................................50SECTIONVTROUBLESHOOTING.........................................................................................................52SECTIONVICAREANDMAINTENANCE...............................................................................................53Care.........................................................................................................................................................53CleanandDisinfecttheIntelliportBaseforReuse.............................................................................53RechargingtheIntelliportBaseforReuse..........................................................................................53DeterminingUsefulLifeforaIntelliportBase....................................................................................53CleaningtheTabletcomputer............................................................................................................54Storage....................................................................................................................................................54Tabletcomputer.................................................................................................................................54IntelliportBase....................................................................................................................................54IntelliportSensor................................................................................................................................55
5Maintenance...........................................................................................................................................55AdministrationandService.....................................................................................................................55SECTIONXIII.APPENDIX....................................................................................................................56AppendixAIntelliportTechnicalSpecifications......................................................................................56AppendixBDisinfectantAgents..............................................................................................................57AppendixCStandards.............................................................................................................................58AppendixDGlossary...............................................................................................................................59AppendixEASADrugCategoryColorSchema........................................................................................61AppendixFMessages..............................................................................................................................62AppendixGAccessories..........................................................................................................................65AppendixHRadioFrequencyWirelessTechnology................................................................................66AppendixIReferenceDocuments..........................................................................................................69AppendixJDescriptionofSymbols.........................................................................................................70
6TableofFiguresFigure1AnesthesiaSystemComponents.....................................................................................................8Figure2IntelliportDevice.............................................................................................................................9Figure3IntelliportSensorwithlast4digitsoftheSerialNumber.............................................................17Figure5EncodedSyringeAttachment........................................................................................................20Figure7StandAloneMode........................................................................................................................21Figure8AnesthesiaView............................................................................................................................22Figure9UnitTotal.......................................................................................................................................23Figure10NursingView...............................................................................................................................24Figure11EMRIntegratedMode.................................................................................................................27Figure12EMRIntegrated(CompanionView)............................................................................................28Figure14Login............................................................................................................................................33Figure15ConnectinganIntelliport............................................................................................................34Figure16PatientSetup...............................................................................................................................35Figure17ADTPatientList...........................................................................................................................35Figure18ConfirmPatientAssociation........................................................................................................36Figure19PatientAllergies..........................................................................................................................36Figure20UserPreferences.........................................................................................................................39Figure21ConnectingAdditionalIntelliports..............................................................................................40Figure22SelectMedication.......................................................................................................................41Figure23ModifySelectedMedication.......................................................................................................42Figure24CocktailMedication....................................................................................................................43Figure25AddInfusion................................................................................................................................44Figure26ModifyInfusion...........................................................................................................................44Figure27AddComment.............................................................................................................................45Figure28MedicationOrders......................................................................................................................46Figure30ReviewCase................................................................................................................................48 
7Importantinformationishighlightedbytheseiconsandterms:WARNINGindicatesapotentialforpersonalinjuryordeath.CAUTIONindicateseitherpotentialdamagetothehardwareorlossofdataandinstructshowtoavoidtheproblem.NOTENOTEindicatesimportantinformationtomakebetteruseoftheAnesthesiaSystem.
8SectionIBackgroundIntroductionThankyouforchoosingtheBDAnesthesiaSystem(AnesthesiaSystem).TheAnesthesiaSystemcanbeusedwhenintravenousbolusinjectionsofmedicationaregiventoapatientbyanurseoranesthetistforautomateddocumentationofmedication,concentration,dose,volumeandtimeofeachIVinjectionduringanoperation,recoveryandproceduralevent.Duringtreatment,theclinicianconnectsanintelligentinjectionport,calledtheIntelliport™device,toapatient'sfluid‐deliverylineandperformsstandarddrug‐deliveryactivities.TheIntelliportdeviceautomaticallycapturesinformationaboutdrugsinjected,andwirelesslytransmitsthatinformationinreal‐timetotheTabletcomputer.TheTabletcomputerusesthatinformationandothermanually‐enteredinformationtodisplayatime‐stampedmedicationrecord.Itprovidestheclinicianwithclinicaldecisionsupport.Italsomakesthatinformationavailableforreportingandelectronicrecordkeepingpurposes.TheAnesthesiaSystemhastwooperatingmodes.Thefirstconfigurationisastand‐alonesystemthatsupportsapaperanesthesiarecord.Thesecondconfigurationinvolvesintegrationwithelectronicmedicalrecordsorperioperativeinformationmanagementsystems(PIMS).Thisguideprovidesinstructionsforthesafeandproperoperationofthedevice,aswellasset‐up,configuration,andcareinformation.ReadthisentiremanualcarefullyandfamiliarizeyourselfwiththefeaturesandoperationoftheAnesthesiaSystempriortouse.ProductDescriptionTherearefourcomponentstotheAnesthesiaSystem:Figure 1 Anesthesia System Components TabletcomputerIntelliportDeviceEncodedSyringesGateway
9Intelliportdeviceisanintelligentinjectionport.Itattachestoaninjectionsite(“YSite”orstopcock)formanuallyadministeredIVinjections.ItiscomprisedofaSensorandaBase,whichsnaptogetherpriortouse.TheIntelliportSensorisasteriledisposablehavinganinjectionportandaLuerconnection.TheIntelliportSensorissuppliedinasterilepackageforsinglepatientuse.TheIntelliportBaseisanon‐sterile,reusabledevicethathousestheelectronicsandwirelesstransmitter.Itisbatterypowered,andrechargeable.AseparateRechargerrechargesabatteryinthereusableIntelliportBasepriortoeachuse.Figure2IntelliportDeviceEncodedSyringesarecommercially‐availabledrugsinprefilledsyringeswithaspecialidentifier,called“encoding”,thatstoresinformationaboutthemedicationcontainedwithinthesyringe.Encodedsyringesareready‐to‐use,passiveanddisposable.TheAnesthesiaSystemalsoaccommodatessyringesnothavingencoding.TabletComputerrunstheAnesthesiaSystemsoftware.Itcontinuouslycapturesanddisplaysthemedicationadministrationrecord(MAR)datafromtheIntelliportdeviceeachtimeaninjectionoccurs.Italsoenablesclinicianstomanuallydocumentotherpertinentclinicalinformation,anditprovidesclinicaldecisionsupporttohelpimprovesafetyandaidcliniciansduringtreatment.GatewayissoftwarethatenablestheAnesthesiaSystemtofunctionasanenterprisedeviceandinformationsystem.TheGatewayprovidesacentralhubtowhichallTabletcomputersconnectviathehospitalnetwork.ItalsoincludesaninterfaceenginefortheAnesthesiaSystemtoexchangedatawithothernetworkedhospitalinformationsystems,alongwithasuiteofutilitiesforgeneralGatewayimplementation,operation,andmaintenance.TheGatewayincludesabrowser‐baseduserinterfaceforadministratorsoftheAnesthesiaSystemtoconfigurethedevicelibraryandTabletcomputerdefaultsettings.IntelliportBaseIntelliportSensor
10HowitWorksThemedicationadministrationprocessusingtheAnesthesiaSystemisillustratedinFigureXXX.Priortotreatment,theclinicianprimesandconnectstheIntelliportdevicetothepatient’scatheterorinjectionport(y‐site).Duringmedicationadministration,theclinicianperformsstandarddrug‐deliveryofbolusmedications.Whenasyringeisattachedtotheinjectionport,theIntelliportdeviceidentifiesthemedicationandconcentrationforanencodedsyringebyopticallyimaginganddecodingabarcodeonthetipofthesyringe.ThisinformationiswirelesslytransmittedtotheTabletcomputer,andtheTabletcomputerdisplaysandannouncesthedrugattached.Italsomayperformsafetychecks.Asdrugispushed,theIntelliportdevicemeasuresthevolumedosedultrasonically.TheIntelliportdevicewirelesslysendsvolumemeasurementinformationtotheTabletcomputer.TheTabletcomputerusesthisinformationtoprovideclinicianswithclinicalinformation.Themedicationadministrationinformationistimestampedanddisplaysforclinicalreferenceduringsurgicalprocedures.Manuallyenteredinfusionsandotherinformationpertainingtonon‐encodeddruginjectionsmaybeincludedinthepatientmedicationrecord.TheTabletcomputerwirelesslycommunicateswiththeGatewayonthehospitalnetwork,anditmaysendmedicationadministrationtoHospitalInformationSystems,whenconfigured,forreportingandelectronicrecordkeepingpurposes.
11IndicationsforUseTheAnesthesiaSystemprovidesarecordkeepingsystemwithpatientsafetyfeatures.Electronicavailabilityofthepatient’sallergiesallowsforproactiveadversedrugeventscreeningwhenthepatientisintheperioperativeenvironmentpriortoanyanesthesiadrugdelivery.TheAnesthesiaSystemautomaticallydocumentsmedicationsinthepre‐op,intra‐op,andPACUareaswhenusinganencodedprefilledsyringe.Thecliniciancanenterdrugmedicationbymanuallyselectingthedrugfromalistwhenusingasyringethatisnotencoded.Adruglibrary,managedbypharmacy,containsdrugspecificinformationusedfordocumentingdrugsontheanesthesiarecord,performingadversedrugeventchecks,andsubmittingmedicationutilizationinformationforbillingpurposes.Availabilityofthepatient’sspecificdrugallergiesprovidesforpre‐screeningofthemedicationsthatareconnectedtotheIntelliportdeviceforinjectiontocheckforanypotentialadversedrugevents.Italsoprovidesamethodologyfornarcoticstrackingthroughitscomprehensivemedicationtrackingandwastingfeature.TheAnesthesiaSystemistobeusedinthehospitalperi‐operativeenvironments(inpatientandoutpatient)andspecialprocedurerooms.TheAnesthesiaSystemmayalsobeusedinnursingcareunitsforthetreatmentofpreandpostsurgicalpatientcare.Surgical/procedurepatientsshouldweighgreaterthan35kgs,andhaveanintravenouslineestablished.Thesystemmayalsobeusedinnursingcareunitsforthetreatmentofpre‐andpost‐surgicalpatientcare.ThecliniciansthatareintendedtousetheCRISIAnesthesiaSystemincludephysicianswithaspecialtyinanesthesiology,CertifiedRegisteredNurseAnesthetistsandRegisteredNurses.Theseindividualsarelicensedtodelivermedicationsthroughapatient’svenousaccesspoint.(IFU026)TheIntelliportSensormaybeusedupto72hours.Itisnotintendedtobereused.TheIntelliportBaseisintendedforusewiththeIntelliportSensor.ItmaybereusedunlessithasaexceededitsUsefulLife.Itshouldbedisinfectedandfullyre‐chargedbetweenpatientuses.IntendedUseTheAnesthesiaSystemisanautomatedrecordkeepingsystemforuseinperioperativeandproceduralsettings.Thesystemiscomprisedofainjectionportthatmeasuresadministrationofmedicationstopatients,andadataprocessingmoduletoautomatetracking.Thesystemalsoincorporatespatientsafetyfeatures(alertsforpatientallergies)thatarealignedwithhospitalpatientrecordsandprotocols,anditincludesamethodologyfornarcoticstrackingthroughacomprehensivemedicationtrackingandwastingfeature.TheAnesthesiaSystemhasbothdisposableandreusableparts,andtheoverallsystemisintendedforprescriptionuseonly.TheIntelliportdeviceisintendedtobeusedonaY‐site,stop‐cockorIVmanifoldinjectionportofanyperipheralintravenousestablishedline.Thisincludesacentralvenouslineorperipherallyinsertedcentralcatheter(PICC)line.Itisnotintendedtobeusedintheintra‐arterialorepidurallines.Venouslinescanbeestablishedinthesubclavian,femoral,intraosseousorvariousperipheralarmlocations.TheIntelliportdevicemayrestorbesecuredtothepatient’sskinineitheroftheselocations.
12SectionIISafetyPrecautionsTheinformationcontainedintheseInstructionsforUseisintendedtoassistinthesafeoperationoftheAnesthesiaSystem.ThisproductistobeusedasspecifiedwithintheseInstructionsforUseandinaccordancewithfederalguidelines.READALLINSTRUCTIONSBEFOREUSING.SAVETHESEINSTRUCTIONS.WarningsandPrecautionsGeneralDonotusetheAnesthesiaSystemnearMagneticResonanceImaging(MRI)equipment,includingstereotaxistechnology.(IFU017)RemovetheIntelliportdevicefromtheIVY‐sitepriortoimaging.DonotusetheAnesthesiaSystemneartherapeuticradiationequipment,suchaslinearaccelerators.RemovetheIntelliportdevicefromtheIVY‐sitepriortoimaging.Shockhazard:donotattempttoconnectordisconnecttheTabletcomputerorIntelliportRechargerpowercordwithwethands.Makecertainthatyourhandsarecleananddrybeforepressingthepowercord.UseonlythepowercordsuppliedbythemanufacturerfortheTabletcomputerorIntelliportRecharger.Neveradapttheplugtofitanonstandardoutlet.Inspectthepowersupplycordfordamagepriortouse.ReplacetheTabletcomputerpowersupplyonlywiththeCRISIapprovedpowersupply.Observerequirementsforpropergrounding.Thepowerreceptaclemustbeathree‐wiregroundedoutlet.Ahospitalgradeoutletisrequired.NeveradaptthethreeprongplugfromtheTabletcomputertofitatwo‐slotoutlet.Iftheoutlethasonlytwoslots,makesurethatitisreplacedwithathree‐slotgroundedoutletbeforeattemptingtooperatetheTabletcomputer.Provideanisolatedpowersupplyforoperation.Universalprecautionsshouldbeobservedtopreventcontactwithbloodorotherpotentiallyinfectiousmaterials.Placecontaminatedmaterialsinaregulatedwastecontainer.Donotmixdisinfectingsolutions(e.g.,bleachandammonia)neartheAnesthesiaSystem,ashazardousgasesmayresult.Useaccessoryequipmentrecommendedbythemanufacturer.Theuseofnon‐approvedaccessoryequipmentwiththeAnesthesiaSystemisnotrecommended,andmayleadtounsafeconditions.Donotmodifyortamperwithsystemcomponentsforanyreason.Doingsowillvoidthemanufacturerwarranty.Thesystemdoesnotincludeserviceablecomponents.Contact
13yourAnesthesiaSystemrepresentativeforallrepairs.Donotusedamagedequipment,frayedordamagedpowercords.(IFU023)DonotexposetheAnesthesiaSystemtogasorheatsterilization.AutoclavingwillseriouslydamagetheIntelliportBaseandTabletcomputer.AvoidliquidingresstotheTabletcomputerorIntelliportBase.Fluidsmayinterferewiththeirperformance.Operationofelectroconvulsivetherapy(ECT)equipmentduringuseoftheAnesthesiaSystemmaytemporarilyresultinsignallossbetweentheIntelliportdeviceandTabletcomputer.NOTEIfanypartoftheAnesthesiaSystem(Tabletcomputer,Intelliportdevice,Recharger)isdroppedorseverelydamaged,immediatelyremoveitfromuseandhaveitinspectedbyservicepersonnel.Ensureitsproperfunctionpriortoreuse.TabletcomputerThegroundleakagecurrentislessthanspecifiedlimitsestablishedforcommercialTabletcomputerpowersupplies.Asamatterofsafepractice,yourfacilityshouldconductperiodicteststoverifythesecurrents.ItisrecommendedthattheTabletcomputerACpoweradapterbeconnectedtoanisolatedpowersupply.Electricalshockhazard:DonotremovetheTabletcomputercover.ThereareNOserviceablepartsinsidetheTabletcomputer.Iftheintegrityoftheexternalprotectiveearthgroundisindoubt,theTabletcomputercanbeoperatedfromitsinternalbatterypowersource.SustainedcontactoftheTabletcomputerwithskincancausediscomfortorburns.DonotallowtheTabletcomputertorestdirectlyonexposedskinforextendedperiods.ThesurfacetemperatureoftheTabletcomputermayriseduringnormaloperationparticularlywhenoperatingunderACpower.BesuretheTabletcomputerismountedsecurelyinplacetoavoidfallingandsustaininginjury.Tocompletelyremovepowerfromtheunit,disconnectthepowercordfromthepowerreceptacleoftheTabletcomputer.ProperlysecuretheTabletcomputerpriortouseorafterpositioning.DonotlooselyplacetheTabletcomputeronotherequipment.(IFU022)DonotblockventilationinletholesontheundersideoftheTabletcomputer.
14DonotopenormodifytheTabletcomputerforanyreason.Thereisasealtopreventliquidsfromentering,whichmaybedamagedifopened.NOTETheTabletcomputercanonlybeusedwiththeAnesthesiaSystem.NOTEBeforeeachuse,checkthevolumeofaudiblealertstoensuretheyarenotmuted.Silencingthealertsmayadverselyaffectpatientsafety.NOTEDonotpushanyobjectsintotheairventsorotheropeningontheTabletcomputer.Doingsocancausefireorelectricshock.NOTEDonotusepressurizedsprayswhencleaningtheTabletcomputerscreen.NOTEDonotusehardorpointedobjectsontheTabletcomputerscreen.IntelliportdeviceIntelliportdeviceshouldnotbeusedwithanArterialorepiduralline.Thismayresultinseriousinjurytothepatient.VerifythelineplacementpriortoIntelliportY‐siteattachment.(IFU011)DonotuseaneedleorbluntplastictipcannulawiththeIntelliportSensor.Thismayresultinportvalvedamageresultinginfluidleaks,airintakeandbacterialcontamination.ReplacetheIntelliportSensorimmediately.PrimetheintravenouslineandIntelliportSensorwithflushsolutionpriortobeginninganinjection.TrappedairmayaffectIntelliportSensorperformanceandtheinjectedvolumemeasurement.FailuretoprimetheIntelliportSensorcorrectlymaycausethevolumeofinjectedmedicationtoreadlowerthantheactualtotaldeliveredtothepatient.CheckforanblockedfluidpathorleakingfittingswhenprimingtheIntelliportSensor.SecuretheIntelliportdevicetothepatientpriortopatienttransporttoavoidintravenouslinedisruption.(IFU021)NotetheclarityoftheIVtubingandIntelliportSensorduringusetominimizebacteriagrowth.ReplacetheIntelliportSensorifahighlipidmedicationhasbeeninjectedorbloodisvisibleinsidethelumenoftheIntelliportSensororport.DonotusetheIntelliportSensorwithanIVlineusingahighpressureinfusionflowsystem.VerifythelineplacementpriortoIntelliportY‐siteattachment.
15ThisdevicecomplieswithPart15oftheFCCRules.Operationissubjecttothefollowingtwoconditions:(1)Thisdevicemaynotcauseharmfulinterference,and(2)Thisdevicemustacceptanyinterferencereceived,includinginterferencethatmaycauseundesiredoperation.ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforClassBDigitalDevice,pursuanttoPart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonableprotectionagainstharmfulinterferenceinaresidentialinstallation.Thisequipmentgeneratesandcanradiateradiofrequencyenergyand,ifnotinstalledandusedinaccordancewiththeinstructions,maycauseharmfulinterferencetoradiocommunications.However,thereisnoguaranteethatinterferencewillnotoccurinaparticularinstallation.Ifthisequipmentdoescauseharmfulinterferencetoradioortelevisionreception,whichcanbedeterminedbyturningtheequipmentoffandon,theuserisencouragedtotrytocorrecttheinterferencebyoneormoreofthefollowingmeasures.•Reorientorrelocatethereceivingantenna•Increasetheseparationbetweentheequipmentandreceiver•Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiverisconnected•Consultthedealeroranexperiencedradio/TVtechnicianforhelpAnychangesormodificationsnotexpresslyapprovedbythepartyresponsibleforcompliancecouldvoidtheuser’sauthoritytooperatetheequipmentLeschangementsoumodificationsnonapprouvésexpressémentparlapartieresponsabledelaconformitépourraitannulerl'autoritédel'utilisateuràfairefonctionnerl'équipement.ThisdevicecomplieswithIndustryCanadalicence‐exemptRSSstandard(s).Operationissubjecttothefollowingtwoconditions:(1)thisdevicemaynotcauseinterference,and(2)thisdevicemustacceptanyinterference,includinginterferencethatmaycauseundesiredoperationofthedevice.LeprésentappareilestconformeauxCNRd'IndustrieCanadaapplicablesauxappareilsradioexemptsdelicence.L'exploitationestautoriséeauxdeuxconditionssuivantes:(1)l'appareilnedoitpasproduiredebrouillage,et(2)l'utilisateurdel'appareildoitacceptertoutbrouillageradioélectriquesubi,mêmesilebrouillageestsusceptibled'encompromettrelefonctionnement.)
16DonotusetheIntelliportSensorwithanIVlineusingahighpressureinfusionflowsystem.VerifythelineplacementpriortoIntelliportY‐siteattachment.VerifytheencodinglabeliscleanandsecuretothesyringetippriortoattachingtotheIntelliportSensor.DisposeoftheIntelliportBaseitaccordingtoyourfacility’sprotocolforbatterydisposaloflithiumionbatteries.DiscardtheIntelliportSensorifitssterilepackagingisnotintactortheprotectorcapisdetached.CliniciansmustbefamiliarwithandbetrainedintheuseoftheAnesthesiaSystem.Itsuseshouldbeprecededbyanestablishedfacilityprotocol.Swabtheinjectionportwith70%isopropylalcohol(ortheagentthatishospitalstandard)andallowtodrypriortoeachsyringeinjectiontominimizethepotentialforcrosscontamination.ChangetheIntelliportSensoraccordingtofacilitypolicyforIVsetchangeorCDC(USA)Guidelines;oriftheintegrityoftheIntelliportdevicehasbeencompromised.(IFU025)TheAnesthesiaSystemisneitherdesignednorintendedtodetectnoralertifthereareneedleinfiltrations.Hospital/facilitypersonnelmustensuretheperformanceofthecommonIVsite,priortoconductingbolusinjections.NOTEVerifythattheIntelliportdeviceissecurelyluerlockedtotheY‐siteandtheIVtubingisfreefromkinksbeforeoperating.NOTETheIntelliportSensordoesnothaveastopvalve(checkvalve);therefore,itisrecommendedtoclosetheupstreamflowontheIVlineduringinjectiontolimitretrogradeflow.
17SectionIIIDescriptionofAnesthesiaSystemComponentsTheAnesthesiaSystemisdesignedwithyourneeds,safetyandworkflowinmind.ThissectionwillfamiliarizeyouwiththeAnesthesiaSystemcomponents,operationalmodes,displayviews,controls,andindicators.SuppliesandEquipmentTheAnesthesiaSystemisdesignedforusewiththefollowingequipment. IVvenouslinewithY‐siteneedlelessport(s),stopcockormanifold Intelliportdevice(sterilepackagedIntelliportSensorandchargedIntelliportBase) Medicationsyringes(havingencodingandwithoutencoding) Tabletcomputer RechargerIntelliportTheIntelliportdeviceisanintelligentinjectionport.Itattachestoaninjectionsite(“YSite”orstopcock)formanuallyadministeredIVinjections.Itiscomprisedofasingle‐useIntelliportSensorandareusableIntelliportBase,whichsnaptogetherpriortouse.UptothreeIntelliportdevicesmaybeinusewithapatientatonetime.ThesemaybeattachedtotwoorthreeseparateIVlinesforthepatientorattachedviaamanifoldordifferentY‐sitesonthesameIVline.TheIntelliportdevicehasmemorythatwillstoreatime‐basedmedicationhistorylogfromthetimeofactivationtothetimewhenthedataissenttoaTabletcomputer.IntelliportSensorTheIntelliportSensorisasteriledisposablehavinganinjectionportandaLuer‐lockconnection.TheIntelliportSensorissuppliedinasterilepackageforsinglepatientuse.(IFU020)TheIntelliportSensorhasamaleLuer‐lockconnectiononaone‐inchIVtubingpigtail.ThiscanbeattachedtoanIVlineataY‐siteorIVmanifold.AnIntelliportSensorcannotbereusedwithadifferentpatient.EachIntelliportSensorhasauniqueserialnumber.Thelast4digitsoftheserialnumberareimprintedonthesurfacenexttoitsbarcode.ThisnumberisusedtoidentifyanIntelliportSensorwithinwirelessrangeusingtheTabletcomputer.Figure3IntelliportSensorwithlast4digitsoftheSerialNumberLast4digitsofSerialNumber
18Figure4IntelliportDeviceComponentsTheIntelliportSensorincludesaninjectionportandanIVconnectiontotheIVline.Theinjectionportisacommonneedleless,Luer‐locktype.Itmaybecleanedpriortogivinganinjectionaccordingtohospitalpolicy.PrimingwithanIVfluid(e.g.normalsalinesyringe,orpullbackfromIVline)isrequiredbeforeuse.TheinjectionportontheIntelliportSensorsupportsupto100injections.TheIntelliportSensorispackagedsterile,donotuseifpackageisdamagedorprotectorcapisnotattached.Donotuseaneedleorblunttipplasticcannula.ReplaceimmediatelyifeitherisinadvertentlyusedresultingindamagetotheIntelliportSensor(typicallyleaks).PrimeIntelliportSensorbeforeuse.AttachaflushsyringetotheinjectionportandpurgeinfusionfluidtoremoveairfromtheIntelliportSensor.ConfirmtheLuerlockissecurelyconnectedtoafullyprimedprimaryinfusionsetbeforeuse.DiscontinueuseoftheIntelliportSensorifthesyringeissecurelyattachedandyouobserveleaking(dropletsformingattheinjectionport)duringaninjection.NOTEUseAsepticTechniquewhenhandlingtheIntelliportSensor.IntelliportBaseTheIntelliportBaseisanon‐sterile,reusabledevicethathousesthebattery,electronicsandwirelesstransmitter(calledaRadio).Itisbatterypowered,andrechargeable.Donotdiscardafteruse.AnIntelliportBaseisdesignedtobereusable.Itsupportsupto500re‐useswithdifferentpatients.EachIntelliportBasehasauniqueserialnumberimprintedonitssurface.ThisnumberistransmittedtotheTabletcomputerduringuse.ThedistancebetweentheIntelliportdeviceandaTabletcomputershouldbe10metersorlessinorderfortheIntelliportdevicetosendandreceivewirelesscommunications.Therechargeablelithiumbatteryisnotremovable.TheentireIntelliportBaseconnectstotheRecharger.Afully‐chargedIntelliportBaseissuitableforupto24hoursofuse,undertypicalconditions.
19WhentheIntelliportBaseisconnectedtoaRecharger,upto4greenlightbarswillilluminate.Thenumberofsolidgreenlightbarsindicatesthelevelofcharge.Theblinkinglightwillindicateitisrecharging.upto25%chargedupto50%chargedupto75%chargedfullychargedverylowbattery≤5%WhentheIntelliportBaseisconnectedtoaRechargeraredlightindicatestheIntelliportBasehasexceededitsUsefulLife.RefertoSectionXXCare&Maintenanceformoreinformation.StatusTheIntelliportBaseisequippedwithstatusindicatorstoconveythefollowinginformation:OperatingAdouble‐blinking,greenlightindicatestheIntelliportdeviceispoweredonandnotyetwirelesslyconnectedtoaTabletcomputer.ErrorAredlightindicatesanerrorispresent.RefertoSectionXXTroubleshootingformoreinformation.IdentifyGreen/yellowlightsflashfor3secondswhenanIntelliportdevicehasbeenselectedattheTabletcomputer.ClinicalAlertRed/green/yellowlightsflashfor3secondswhenapriorityclinicalalerthasbeentriggered.ThisinformstheclinicianofanalertmessageontheTabletcomputer.(e.g.aknownallergytoadruginaconnectedsyringe).(IFU010)EndofUse AredlightinthelowestbatterychargepositionindicatestheIntelliportBasehasbeenusedwithmorethan500IntelliportSensors.RechargerAseparateRechargerrechargesthebatteryinthereusableIntelliportBasepriortoeachuse.TousetheRecharger,snapontotheIntelliportBase.EncodedSyringesTheAnesthesiaSystemsupportsinjectionsusinganyLuer‐locktypesyringe.Inaddition,thesystemhasbeendesignedtoworkwithencodedsyringesthathaveaspecialbarcodeidentifieronthesyringetip,called“encoding”.Theencodingstoresinformationaboutthemedicationcontainedwithinthesyringe.
20WhenanEncodedsyringesisattachedtotheinjectionport,thisinformationiswirelesslytransmittedbytheIntelliportdevicetotheTabletcomputer.Figure5EncodedSyringeAttachmentTabletcomputerTheTabletcomputerisastandard,commercialTabletcomputerhavingAnesthesiaSystemsoftware,apressscreen,wirelesscommunications(Radio).Itistypicallymountedneartheclinician’sworkenvelop.Itmayalsoberemovableforhand‐helduse.TheOn‐Offswitchislocatedatthetop,rightoftheTabletcomputer.ItincludesanACpoweradapter.Italsosupportsupto4hoursofbattery‐powereduse,undertypicaloperatingconditions.Figure6TabletcomputerFeatureLayoutReviewTabletcomputerWarningslistedonpagesXXpriortouse.TheTabletcomputersupportsonepatientatatime.SolongasacaseisongoingattheTabletcomputer,noothercasesorpatientscanbeaccessed.Inaddition,onlyoneclinicianmaybeloggedintoaTabletcomputeratatime.SoftwareRunninginStandaloneModeWhenusedinahospitalhavingapaperanesthesiarecord,theTabletcomputersupportsfeaturesthatassistwithdocumentingtheflowsheetportionandmayhelpwithdecisionsbytheclinician.Inthisconfiguration,theTabletcomputercomplementsthepaperrecordkeepingactivitiesbytrackingandEncodedSyringeOn/OffSwitchACpoweradapter
21displayinginjectionsgiventhroughtheIntelliportdevice.ItalsoenablesclinicianstomanuallydocumentotherpertinentIVdruginjectionandinfusioninformation.Thesoftwarescreensfollowathree‐stepapproachconsistingof1)connectingtheIntelliportdevice,2)settingupthepatient,and3)viewingmedicationadministrationineithertheAnesthesiaVieworNursingView.RefertoSectionsXXforinformationonconnectingtheTabletcomputertoanIntelliportdeviceandsettingupapatient.Figure 7 Stand Alone Mode ThefollowingsectiondescribesthebasicscreensontheTabletcomputer:AnesthesiaViewTheAnesthesiaViewisaprimaryscreenforclinicianstointerfacewiththeAnesthesiaSystem.Thisviewprovidesinformationaboutthepatient,displaysdrugname/concentrationanddoseforacurrentinjectionaswellasahistoricallistofmedicationsthathavebeendeliveredtothepatient.Ifmayalsoincludealistingofinfusionsgiventothepatient,ifrecordedbytheclinician.
22Figure 8 Anesthesia View InjectionBars‐Uptothreeinjectionbarsdisplayacrossthetopofthescreen,onecorrespondingtoeachwirelesslyconnectedIntelliport.EachinjectionbarisarealtimerepresentationofthemedicationbeingadministeredthroughanIntelliportdevice.WhenanencodedsyringeisattachedtoanIntelliportdevice,theinjectionbardisplaysthedrugnameandconcentration.Whenanunencodedsyringeisattached,theInjectionBarwillread“SelectMed”promptingthecliniciantoidentifythemedicationandconcentration.Asthemedicationisbeingdelivered,thevolumepushed(inmL)andthecorrespondingdosedisplaysinrealtimeintheinjectionbar.MedicationHistory‐TheAnesthesiaViewincludesahistoricallistofmediationsthathavebeendeliveredtothepatientorganizedbycarearea(medicationsgiveninthetransitiontimebetweencareareas,willposttothenextcarearea)arrangedinaflowsheetformat.ThisincludesallmedicationsthatwereadministeredtothepatientsincetheIntelliportdevicehasbeenactivatedwiththemorerecentmedicationadministrationsatthebottomofthelist.Ascrollbarisenabledwhenthelistexceedsthevisiblespaceonthescreen.Whenanewmedicationisadded,themedicationlistwillscrollautomaticallysothenewmedicationnameisvisible.Handgesturingintheflowsheetwillscrolltheflowsheettoviewhiddenmedicationadministrations.NOTEForanesthesiamedications,acolortilecorrespondingtotheAmericanSocietyofAnesthesiology(ASA)guidelinesdisplaysadjacenttothedrugname.(RefertoAppendixXformoreinformation).Theflowsheettimescaleisadjustableanditcanshow1minute,5minute,and10minuteincrements.
23"Dose"isshownonaflagbasedonthetimeinwhichitwasdelivered.Pressingtheflagforaspecificmedicationwilldisplaythe“ModifySelectedMedication”popup.Fromthispopup,themedicationadministrationcanbeviewedandmodified.Acliniciancanmodifytheconcentration,dose.Thisscreenisalsousedtospecifyacocktail(mixedmedication),adilutedorreconstitutedmedication.Pressingthe“UnitTotal”numberforamedicationwilldisplayapop‐upscreenindicatingthemedicationandconcentration,totaldosegiven,numberofdosesgivenbycarearea,andtimeofeachdose.Toclose,press“OK”onthebottomofthepop‐upscreen.Figure 9 Unit Total TheInfusionsectionislocatedabovethetimescale.Itdisplaysallcontinuousinfusionsrecordedbytheclinician.Thosethatarecurrentlyactiveareshownwithabluebarandthosethatareinactivehaveablackbar.Thisfeaturecanbehiddentoshowadditionalinjectionsbypressing“HideInfusions”fromtheMenu.TheCaseHeaderinformationliststhepatientname,dateofbirth,ageinyears,medicalrecordnumberandpatientidentificationnumber.TheMessageSectiondisplaysclinicalandsystemmessagesprioritizedbyimportanceandtime.TheMessageiconwillshowthenumberofunaddressedmessagesfortheclinician.Clinicalmessagesthathavehigherimportance,suchasallergyalerts,willappearinthecenterofthedisplayscreen.(FigureXX)TheTitleBardisplaysacrossthetopofthescreen.Itincludesthenameoftheclinicianloggedin(ifsoconfigured)andthelocationassignedtotheTabletcomputer.ThefirsticontotherightoftheBarindicatesifwirelesscommunicationbetweentheGatewayandtheTabletcomputerareactive.AsecondiconspecifieswhethertheTabletcomputerspeakersaremutedorunmuted.ThebatteryiconindicatestheremainingamountofchargeontheTabletcomputerandlastly,thehospitalnetworktimeisshown.NursingViewTheNursingViewisasecondscreenforclinicianstointeractwiththeAnesthesiaSystem.LiketheAnesthesiaView,thisviewprovidesinformationaboutthepatient,displaysdrugname/concentration
24anddoseforacurrentinjectionaswellasahistoricallistofmedicationsthathavebeendeliveredtothepatient.Itmayalsoincludealistingofinfusionsgiventothepatient,ifrecordedbytheclinician.Figure 10 Nursing View TheNursingViewhasmanyofthefeaturesintheAnesthesiaView;howeveritisarrangedinatabularformat.Thetableheadingsinthisviewincludemedicationwithconcentration,timeadministered,dose,andunittotal.Themedicationsaredisplayedinreversechronologicalorderwithmostrecentmedicationadministeredatthetopofthelist.Ascrollbarisenabledwhenthelistexceedsthevisiblespaceonthescreen.Handgesturinginthetablewillscrolltoviewhiddenmedicationadministrations.Theblackhorizontalbarsidentifythecareareainwhichthemedicationsweregiventothepatient,orwhentransitioningfromonecareareatoanother.ButtonandMenuOptionsThefollowingfeaturesareavailablefromthefourbuttonslocatedinthelowerrightcornerofthescreen(Allergies,Comments,Add,Menu):AddInfusionSelectthisoptiontorecorddetailsaboutaninfusion.RefertoSectionXformoreinformation.AddInjectionSelectthisoptiontorecorddetailsaboutaninjectiongivenpriortoactivatinganIntelliportdeviceorgiventhroughaportotherthantheIntelliportdevice.RefertoSectionXformoreinformation.AddCommentSelectthisoptiontorecordgeneralcomments.(thereareadditionalwaystopairacommentwithanallergyordrug
25injection).RefertoSectionXformoreinformation.Allergies Selectthisoptiontoviewthelistofallergies,includingseverityandtypeofreaction.PauseCasePressthisbuttonwhentransferringapatienttoanothercarearea.Indoingso,itdisconnectsallconnectedIntelliportdevicesinpreparationfortransfer.RefertoSectionXformoreinformation.CloseCasePressthisbuttonwhenthecaseiscompleteandthepatientisbeingpreparedfortransferoutoftheperioperativearea.Indoingso,itpowersdownallconnectedIntelliportdevices.RefertoSectionXformoreinformation.NOTE:PressingthisbuttonwillclosethecaserecordontheAnesthesiaSystem.Thecasewillnolongerbeavailabletothenextcarearea.SwitchUserSelectthisoptiontochangetheclinicianloggedin,ifsoconfigured.RefertoSectionXformoreinformation.Show/HideInfusionsPressthisbuttontotogglebetweendisplayingorhidinginfusionsontheAnesthesiaViewflowsheet.RefertoSectionXformoreinformation.ChangeTimeScalePressthisbuttontotogglebetween1minute,5minuteand10minutetimeintervalsontheAnesthesiaViewflowsheet.Sound/MutePressthisbuttontotogglebetweenaudibleannouncementsandmute.RefertoSectionXformoreinformation.PreferencesSelectthisoptiontoviewandmodifypreferencesforannouncements,volumeandscreenbrightness.RefertoSectionXformoreinformation.ReportsSelectthisoptiontoviewandprinttheControlledSubstance,Handoff,andMedicationAdministrationreports.RefertoSectionXformoreinformation.HandoffViewPressthisbuttontoviewtheHandoffscreen.RefertoSectionXformoreinformation.NursingViewPressthisbuttontoviewtheNursingViewscreen.RefertoSectionXformoreinformation.
26AnesthesiaViewPressthisbuttontoviewtheAnesthesiaViewscreen.RefertoSectionXformoreinformation.HelpSelectthisoptionwhenseekingassistanceinoperation.Itprovideshelpfulinformation,includingtheDirectionsforUse.(IFU028)ShutDownPressthisbuttontopowerofftheTabletcomputer.RefertoSectionXformoreinformation.
27SoftwareRunninginEMR‐IntegratedModeWhenusedinahospitalhavingelectronicmedicalrecords(EMR)intheperioperativecareareas,theTabletcomputerservesasacompaniontotheEMRsystemorperioperativeinformationmanagementsystem(calledaPIMS).Inthisconfiguration,theTabletcomputerprovidesareal‐timedisplaywhilethedrugisbeinginjected,thenitsendstheinjectionsdatainrealtimetotheEMR.TheclinicianreferstotheEMRforahistoryofmedicationsgiven‐‐unlikethepaperanesthesiarecordconfiguration.Thesoftwarescreensfollowathree‐stepapproachconsistingof1)connectingtheIntelliportdevice,2)verifyingthepatientinformationreceivedfromtheEMR,and3)givinginjections.RefertoSectionsXXforinformationonconnectingtheTabletcomputertoanIntelliportdeviceandsettingupapatient.Figure 11 EMR Integrated Mode TheCompanionViewhasaprimaryscreenforclinicianstointerfacewiththeAnesthesiaSystem.ThisViewprovidesinformationaboutthepatient,displaysdrugname/concentrationanddoseforthecurrentinjectionandrelevantclinicalandsystemmessages.
28Figure 12 EMR Integrated (Companion View) TheCompanionViewconsistsofthefollowingscreenfeatures:1)ActiveInjectionBar;2)TitleBarwithcliniciannameandlocationofdisplayTabletcomputer;3)CaseHeaderinformationonpatientname,MRN,Patientidentificationnumber;4)Allergies;5)ClinicalorSystemMessages.InjectionBars‐Uptothreeinjectionbarsdisplayonthescreen,onecorrespondingtoeachwirelesslyconnectedIntelliportdevice.EachinjectionbarisarealtimerepresentationofthemedicationbeingadministeredthroughanIntelliportdevice.WhenanencodedsyringeisattachedtoanIntelliportdevice,theinjectionbardisplaysthedrugnameandconcentration.Whenanunencodedsyringeisattached,theInjectionBarwillread“SelectMed”promptingthecliniciantoidentifythemedicationandconcentration.Asthemedicationisbeingdelivered,thevolumepushed(inmL)andthecorrespondingdosedisplaysinrealtimeintheinjectionbar.Uponcompletionofthesyringepush,themedicationadministrationwillpassimmediatelytotheEMRwithaconfirmationmessageconfirmingsuchinthemessagearea.NOTEForanesthesiamedications,acolortilecorrespondingtotheAmericanSocietyofAnesthesiology(ASA)guidelinesdisplaysadjacenttothedrugname.(RefertoAppendixXformoreinformation).TheCaseHeaderinformationliststhepatientname,dateofbirth,ageinyears,medicalrecordnumberandpatientidentificationnumber.TheMessageSectiondisplaysclinicalandsystemmessagesprioritizedbyimportanceandtime.TheMessageiconwillshowthenumberofunaddressedmessagesfortheclinician.Clinicalmessagesthathavehigherimportance,suchasallergyalerts,willappearinthecenterofthedisplayscreen.(FigureXX)TheTitleBardisplaysacrossthetopofthescreen.Itincludesthenameoftheclinicianloggedin(ifsoconfigured)andthelocationassignedtotheTabletcomputer.ThefirsticontotherightoftheBarindicatesifwirelesscommunicationbetweentheGatewayandtheTabletcomputerareactive.A
29secondiconspecifieswhethertheTabletcomputerspeakersaremutedorunmuted.ThebatteryiconindicatestheremainingamountofchargeontheTabletcomputerandlastly,thehospitalnetworktimeisshown.
30SectionIVOperationsTheAnesthesiaSystemisdesignedwithyourneeds,safetyandworkflowinmind.ThischapterwillacquaintyouwiththeAnesthesiaSystemoperationalmodes,displayviews,controls,andindicators.Italsoprovidesgeneralinformationonuseofthedevice.QuickGuidePreparetheIntelliportTheIntelliportdevicemustbeprimed,attachedtoanIVlineandassembledinpreparationforuse.1. GatheranIntelliportSensorinitssterilepackagingandafully‐chargedanddisinfectedIntelliportBase.2. PrimebyflushingwithsterileIVfluidbeforeattachingtotheY‐siteORbyaspiratingIVsolutionthroughasyringeattachedtotheport.3. AttachtheIntelliportSensortotheIntelliportBasebyjoiningtheIntelliportSensor(tubingside)andIntelliportBasefrontsectionsfirst,thensnapthetwotogether.Oneshouldaudiblyhearthe“snap”.4. VerifyproperseatingofIntelliportSensortotheIntelliportBasebycheckingforablinkinggreenlightontheIntelliportdevice.Ifthisisnotseen,viewtheIntelliportdeviceonitssidetodetermineifthetwoareproperlyconnected.IfaspaceisseenbetweentheIntelliportSensorandIntelliportBase,thenseparateandre‐attachproperly.5. TheIntelliportdeviceisnowreadyfordeliveryofIVmedications.AnymedicationsgiventhroughtheIntelliportdevicewillbesavedtotheIntelliportmemory.SetuptheTabletcomputerTheTabletcomputermustbesetuptowirelesslycommunicatewiththeIntelliportdeviceandtobeassociatedwithapatientrecord.AnyMedicationsgivenpriortoassociationtoaTabletcomputerwillbeheldintheIntelliportmemory.ThreeIntelliportdevicescanbesynchronizedtoonepatient.6. PowerontheTabletcomputerbypressingandholdingthebuttonlocatedontopofTabletcomputer.7. Thefirstscreensupportslog‐in,ifsoconfigured.EnterUsernameandPassword8. Identifythe4digitnumberontheIntelliportSensor.9. FromtheIntelliportSetupscreen,select(highlight)theIntelliportdevicecorrespondingtothefourdigitsnumberontheIntelliportSensor.10. VerifythecorrectIntelliportdevicehasbeenselectedbycheckingthatthegreenandyellowlightsareblinking.11. IftheidentifiedIntelliportdeviceiscorrect,press“Connect”.12. VerifytheIntelliportdeviceflashesasingle,repeatinggreenlightwhenitiswirelesslyconnectedtotheTabletcomputer.13. Identifythepatient’sfullname,patientID,medicalrecordnumberandbirthdate.14. FromthePatientSetupscreen,selectthepatientfromthelist.Press“Emergency”tobegina
31casewherepatientdemographicsarenotavailable.NOTEAfterstartingacaseusingtheEmergencybutton,thepatientcanbeidentifiedatanytimepriortoclosingthecase.15. “Confirm”thecorrectIntelliportdeviceandpatienttocompletethesetup.Onceconfirmed,theAnesthesiaSystemhasestablishedapermanentassociationbetweenthepatientandIntelliportSensor.GiveIVinjectionsandViewMedicationAdministrations16. CleantheIntelliportSensorinjectionportbyswabbingthehubaccordingtoyourhospitalprotocol.17. AttachasyringetotheIntelliportSensorinjectionport.18. VerifythedrugdisplayedandannouncedbytheTabletcomputeristheintendeddrugandconcentration.Whenusingasyringewithoutencoding,“SelectMed”willannounceanddisplayalistofmedicationstoidentify.(Press“More”ifyoudonotseethemedicationname).a. Identifythemedicationbeforeorafterdosedelivery.Confirmmedicationandpress“Save”.b. Frequentlydilutedorreconstituteddrugsshalldisplaynodosevalueuntiltheclinicianidentifiesthegivendoseonthe“ModifySelectedMedication”screen.Theidentifieddosewillappearontheflag.c. Cocktail(mixingtwomedicationsinonesyringe)canbeidentifiedbypressingthe“Cocktail”buttonfromthe“SelectMed”screen.UseclinicaljudgmentbeforeproceedingwhentheTabletcomputerannouncesanddisplaysaknownallergyforthedrugattachedtotheIntelliportdevice,ifsoconfigured.19. ThevolumeanddosewilldisplayontheTabletcomputerwhenthesyringeisremovedoratendoftheinjection,ifthesyringeisleftattachedtotheIntelliportdevice.
32DetailedOperatingInstructionsPreparetheIntelliportTheIntelliportdevicemustbeprimed,attachedtoanIVlineandassembledinpreparationforuse.1. GatheranIntelliportSensorinitssterilepackagingandafully‐chargedanddisinfectedIntelliportBase.NOTEAfully‐chargedIntelliportBasehassufficientpowerfor24hoursofuseundertypicalconditions.InspecttheIntelliportBasechargelevel.ReplaceanIntelliportBasewithlessthan25%charge.Thiscanbedoneatanytimesolongasaninjectionisnotbeinggiven.VerifytheIntelliportBasehasbeencleanedanddisinfectedbeforeuse.VerifytheIntelliportSensorsterilepackageisintactandthetubingendcapisstillinplace.2. PrimebyflushingwithsterileIVfluidbeforeattachingtotheY‐siteOR,byaspiratingsolutionfromtheIVlinethroughasyringeattachedtotheport.(IFU01)NOTEAfterpriming,visuallyinspectforleaksorblockagetotheIVline.3. AttachtheIntelliportSensortotheIntelliportBasebyjoiningtheIntelliportSensor(tubingside)andIntelliportBasefrontsectionsfirst,thensnapthetwotogether.Oneshouldaudiblyhearthe“snap”.ConnectingIntelliportSensortoIntelliportBasewillautomaticallypowerontheIntelliportdevice.NOTETheconnectionofIntelliportSensortotheIntelliportBaseisverifiedbyablinkinggreenlightontheIntelliportdevice.Ifthisisnotseen,viewtheIntelliportdeviceonitssidetodetermineifthetwoareproperlyconnected.IfaspaceisseenbetweentheIntelliportSensorandIntelliportBase,thentheyarenotattachedproperly.Separatethetwopiecesandre‐attach.4. Whereappropriate,securetheIntelliportdevicetoasurfaceinpreparationforgivinginjections.AvoidkinksinthelinebetweentheIntelliportdeviceandIVline.SecureanIntelliportdevicepriortopatienttransport.5. TheIntelliportdeviceisnowreadyfordeliveryofIVmedications.AnymedicationsgiventhroughtheIntelliportdevicewillberecordedintheIntelliportmemory.IntheeventofaSystemorIntelliportfailure,(excludingthefluidpathway),theIntelliportdevicewillallowstandardmedicationorfluiddelivery.SetuptheTabletcomputer–PaperAnesthesiaRecordTheTabletcomputermustbesetuptowirelesslycommunicatewiththeIntelliportdeviceandtobeassociatedwithapatient.
336. TurnontheTabletcomputerbypressingandholdingthepowerswitchontopofTabletcomputer.NOTETheTabletcomputercanoperatefor4hoursonbatterypower(notpluggedintoapowersupply)undertypicalconditions.VerifytheTabletcomputerispluggedinpriortousebycheckingthepowerindicatorontheTitlebarontheTabletcomputerscreen.NOTEOnstartup,theinitialscreenwilldisplayinformationaboutthesoftware,druglibraryandconfigurationversions–aswellasinformationonnetworkconnectivity.ContactyourSystemAdministrationifsoinstructed.7. TheLoginscreenwilldisplayiftheAnesthesiaSystemisconfiguredforuserlogin.TypetheUserNameandPassword,thenpressthe“Login”button.Figure 13 Login NOTETheTabletcomputerwilllocktheuseroutafterseveralunsuccessfulloginattempts.FollowthescreendirectionsforcontactingtheSystemAdministrator.(IFU029)8. Identifythe4digitnumberontheIntelliportSensor.Figure14Login9. AlistofIntelliportdeviceswithinwirelessrangeareviewableontheIntelliportSetupscreen.Select(highlight)yourIntelliportdevicebytimeofinitialactivationandlastfourdigitsoftheserialnumberontheIntelliportSensor.Lastfourdigitsofserialnumber
34Figure 15 Connecting an Intelliport NOTEAlowbatteryiconwilldisplayforalistedIntelliportwhenlessthan25%ofbatterychargeremains(approximately4hoursundertypicalconditions).Considerreplacingwithafully‐chargedIntelliportBasebeforeconnecting.10. SelecttheIntelliportdeviceforyourpatientbypressingandhighlightingtheappropriateIntelliportserialnumber.11. VerifythatthegreenandyellowlightsareflashingforthecorrectIntelliportdevice.NOTEShouldyoumissthevisualconfirmation,highlighttheappropriateIntelliportdeviceagaintoinitiatetheblinkinglights.12. Thescreenwillhighlightyourconnection.13. TheIntelliportdevicewillilluminateasingle,repeatinggreenlightwhenitiswirelesslyconnectedtotheTabletcomputer.14. Identifythepatient’sfullname,patientID,medicalrecordnumberandbirthdatefromthepatientandwristband.15. FromthePatientSetupscreen,selectthepatientfromthelist.
35Figure 16 Patient Setup Ifthepatientisnotlisted,pressthe“MorePatients”buttontofindthepatientontheADTlistbyfilteringthislongerlistbythepatientname,patientIDorMRN.AkeyboardwillappeartotypethefirstlettersoftheLastName.Figure 17 ADT Patient List NOTEThereisan“Emergency”buttonontheTabletcomputerscreenforpatientswhosenameisnotknownorthecliniciandeterminesanemergentsituationtostartmedicationtreatment.16. Pressthe“Confirm”buttontocompletethesetup.(IFU027)Shouldanypartoftheassociationbeincorrect,thereisanopportunitytopressthe“Remove”buttonandrepeatthepatientidentificationstepprocess.(Figure18)Onceconfirmed,theAnesthesiaSystemhasestablishedapermanentassociationbetweenthepatientandIntelliportSensor.TheIntelliportSensorcanonlybepairedwithonepatient.
36Figure 18 Confirm Patient Association NOTEIfthewrongpatientwasinadvertentlyconfirmedtotheIntelliportdevice,thereisa“RemoveIntelliport”buttonontheMainMenubuttonthatwilldisassociatethepatientfromtheIntelliportdeviceandundoanymedicationadministrationhistory.ShouldtheIntelliportBasebecomedisconnectedfromtheIntelliportSensorduringoperation,reattachandverifypatientassociation.17. FollowingPatientSetup,theTabletcomputerdisplaysallergiesfortheselectedpatient,ifsoconfigured.Knownallergies,withseverityandtypeofreactionwilldisplay(FigureXX).Figure 19 Patient Allergies
37NOTEIfthepatientallergiesarenotavailablefortheTabletcomputer,theclinicianwillseeamessage“UnabletoObtain”.NOTETheTabletcomputerchecksforupdatestopatientallergyinformationduringacase.18. ThereisanopportunitytotypeacommentforanallergybyselectingtheAllergyandpressingtheCommentbutton.Akeyboardwilldisplaytotypeacomment.(Figurexx)19. Oncethecommentisrecorded,pressthe“OK”buttontosave.ThiswillreturntotheAllergylist.GiveanIVinjectionUsingtheIntelliportDevice20. Cleantheinjectionportbyswabbingthehubaccordingtoyourhospitalprocedure.(IFU013)21. AttachasyringetotheIntelliportinjectionport.Doublecheckeachmedicationnameandconcentrationonthesyringepriortoattachmenttotheinjectionporttoassure“rightmedication.”(IFU02)1. VerifythedrugdisplayedandannouncedbytheTabletcomputeristheintendeddrugandconcentration.(IFU019)Forsyringesnothavingencoding,refertoSection:SpecialActivities;MedicationDeliverywhenSyringesNotEncoded,thenreturntothisstep.(IFU04)2. TheIntelliportdevicewillflashred,greenandyellowlightsifamedicationallergyisdetected,ifsoconfigured.UseclinicaljudgmentbeforeproceedingwhentheTabletcomputerannouncesanddisplaysaknownallergyforthedrugattachedtotheIntelliportdevice.Allergymessageswilldisplayasbelow:3. ThereisnocheckvalveintheIntelliportSensor,socloseorpinchtheupstreamIVtubingoruseacheckvalveIVsettopreventmedicationtravelingtowardstheIVbagduringinjection.(IFU009)NOTEAlternativestopreventretrogradeflowinclude:1)attachingathree‐waystopcockontotheY‐siteandluerlockingtheIntelliportSensorontothestopcock;2)attachingamanifoldtotheIVorextensiontubingandluerlocktheSensordirectlytothemanifold.4. Whendeliveringmedications,observethegraduationsonthesyringetochecktheamountofdrugdelivered.(IFU003)VerifydoseshownintheactiveinjectionbaroftheTabletcomputer.(IFU007)TheIntelliportdevicemeasures0.4mLto55mLperinjection.(IFU008)
38NOTEIftheinjectionflowrateisveryslow,amessagewilldisplayontheTabletcomputer.(IFU031)Iftheamountofinjectedmedicationisnotmeasurable,theactiveinjectionbarwillindicate“dashes”forvolumeanddose.Amessagewillinstructthecliniciantoenterthedosemanuallythroughthe“ModifySelectedMedication”screen.Oncecompleted,thedosewilldisplay.RefertoSectionXXXformoreinformation.NOTEPushingmedicationfroma50mLsyringerapidlyhasthepotentialtocausecollapseoftheIVline.Pushslowertoaccommodatedeliveryofalargeamountofmedication.5. FollowallinjectionsthroughtheIntelliportdevicewithanencodedNormalSalineflushtoensurethefulldoseofmedicationsreachesthepatient,especiallywhensuccessivelydeliveringtwoincompatiblemedications.(IFU06)NOTENormalSalinewillappearontheactiveinjectionbarwiththeamountofmLdelivered.Normalsalinemaynotdisplayonthemedicationhistory,ifsoconfigured.6. MakeadjustmentstothemedicationadministrationrecordontheTabletcomputerforinjectionsinvolvingadiluteddrug,reconstituteddrug,ormixeddrugs,ifsoconfigured.InjectionsarerecordedwhetherornottheIntelliportdeviceiswirelesslyconnectedtotheTabletcomputer.TheIntelliportBasestoresinjectioninformationinitsmemoryandtransmitsthisinformationuponwirelessconnectiontotheTabletcomputer.(IFU030)
39SpecialActivitiesSettingUserPreferencesTheAnesthesiaSystemsupportsuserpreferencestodeterminethesoundvolume,screenbrightnessandaudibleannouncements,remindersandmessages.(IFU016)Thehospitalhasconfigureddefaultpreferencesthatmaybemodifiedtemporarilyduringacase.ToverifytheTabletcomputerpreferencespriortostartingacase,performthefollowing:1. SelectPreferencesfromtheMenu.2. Adjustpreferencefortheworkenvironment.3. Press“Save”buttonwhencompleted.Checkwhetheralertshavebeenmutedwhenrelievingaclinicianduringacase.Preferencechangesareretainedduringthecase.Whenthecasehasclosedorwhenanewclinicaluserlogsin,thesettingsreverttothedefaultconfiguration.Figure 20 User Preferences Selectingthe“Mute”optionfromtheMenuwilloverridealloftheaboveselectionsandmutealldrugannouncements,clinicalremindersandsystemmessages.Tohearthemedicationannouncements,select“Unmute”.AddingAdditionalIntelliportsTheAnesthesiaSystemcanaccommodateupto3Intelliportdevicesconnectedtoonepatientatatime.AnadditionalIntelliportdevicecanbeaddedatanytimeduringacase.ThefirstconnectedIntelliportdevicewilldisplayintheleftmostinjectionbar.Thesecondinthemiddle,andthethirdtherightmostinjectionbar.RefertoFigure6.NOTEWhenanIntelliportisconnectedtoaTabletcomputerandthereisnosyringeattachedtotheIntelliportdevice,theactiveinjectionbarshallread“IntelliportConnected,Nosyringeattached”.Abatterystatusiconwillindicatebatterychargelevelinthecorneroftheinjectionbar.
40ToaddanIntelliportdevice:1. PrepareanIntelliportdeviceaccordingtotheinstructionsinSectionX.2. Press“TaptoConnect”onanyoftheremainingActiveInjectionBarspacestodisplayapop‐upwindowthatlistsavailableIntelliportdeviceswithinwirelessrange.3. Identifythe4digitnumberontheIntelliportSensor.4. Select(highlight)yourIntelliportdevicebasedonthetimeofinitialactivationandthefourdigitnumberontheIntelliportSensor.Figure 21 Connecting Additional Intelliports NOTEAlowbatteryiconwilldisplaywhentheselectedIntelliportdevicehaslessthan10%ofbatterypowerremaining.5. TheselectedIntelliportdevicewillflashlightsfor3seconds.6. VerifythegreenandyellowlightsareflashingforthecorrectIntelliportdevice.NOTEShouldyoumissthevisualconfirmation,highlighttheappropriateIntelliportdeviceagaintoinitiatetheflashinglights.7. IftheidentifiedIntelliportdeviceiscorrect,press“Connect”.8. VerifytheIntelliportdeviceisflashingasingle,repeatinggreenblinkinglightindicatingitiswirelesslyconnectedtotheTabletcomputer.9. PressConfirm.AnActiveInjectionBarwilldisplaytheconnectedIntelliportdevice.MedicationDeliverywithSyringesNotEncodedTheAnesthesiaSystemisdesignedtoworkwithbothencodedsyringes(thosehavingaspecialbarcodeidentifieronthesyringetip)andunencodedsyringes.WhenanunencodedsyringeisattachedtotheIntelliportdevice,theTabletcomputerwilldisplaythe“SelectMedication”pop‐uphavingaperioperativemedicationlist.(IFU018)Acliniciancanidentifythemedicationinthesyringebefore
41givingtheinjection(recommended)orafterwards.Ifpostponed,theTabletcomputertracksinjectionsnotyetidentifiedandlaterpromptsthecliniciantoresolve.1. SelectthemedicationandconcentrationfromtheFrequentUselistbyhighlightingthename.Thislistincludesmedicationspreviouslyidentifiedduringthecaseasgivenbyanunencodedsyringe.Figure 22 Select Medication 2. IfthedesiredmedicationisnotfoundontheFrequentUselist,press“More”toviewalongerlistofperioperativemedications.3. Filterthelistbypressingthefirstlettersofthedrugnameusingthekeypad.4. Highlightthedesiredmedicationandconcentration,verifytheinformationandpress“Save”.(IFU05)SpecifyingaDilutedorReconstitutedMedicationTheTabletcomputerprovidesasimpleapproachtodocumentmedicationsthatrequiredilutionorreconstitutionfromapowderformpriortopreparationforinjection.Ittracksfrequentlydilutedandreconstitutedmedications.TheTabletcomputerpromptsthecliniciantoconfirmwhetheradrughasbeendilutedorreconstituted.Ifnot,nouseractionisrequired.NOTEReconstituteddrugsdonotdisplayadosevalueuntiltheclinicianmodifiesthemedication.5. Tospecifyadilutionorreconstitution,press“Modify”onthe“SelectMedication”popup.Orpressonthedoseflag(AnesthesiaViewflowsheet)ordoserow(Nursingview)andpressModify.6. ChangethemedicationconcentrationordosebypressingtheConcentrationbox,thenenterthe
42concentrationvalueusingthenumericalkeypad.7. Reviewthenumbersentered,thenpress“Save”buttontorecordthenewvalue.(IFU017)Thischangewillbereflectedinthemedicationadministrationhistory.Figure 23 Modify Selected Medication SpecifyingaMixedMedication(Cocktail)Addingtwomedicationsintoonesyringeiscalledamixedmedicationorcocktail.Dependingonyourinstitution,mixedmedicationsmayincludethefollowing: Propofol/lidocaine Propofol/fentanyl Propofol/ketamine Neostigminemethylsulfate/glycopyrrolate Atropine/edrophonium Narcan/edrophoniumTheTabletcomputerprovidesasimpleapproachtodocumentmixedmedications.Ittracksfrequentlymixedmedications,anditpromptsthecliniciantoconfirmwhetheradrughasbeenmixed.Ifnot,nouseractionisrequired.1. Tospecifyamixedmedication,press“Cocktail”onthe“SelectMedication”popup.Orpressonthedoseflag(AnesthesiaViewflowsheet)ordoserow(Nursingview)andpress“Cocktail.”2. The“ModifySelectedMedication”popup(Figure24)displaystwomedicationnames;withthefirstonealreadyidentified.3. SelectthesecondMedicationfromthelist.Iftheintendedmedicationisnotlisted,press“More”andtheclinicianmayidentifythecorrectmedicationfromthe“FrequentUse”orperioperativedruglibrarylist.
43Figure 24 Cocktail Medication 4. Enterthevolumeinjectedforeitherdrug.TheTabletcomputerwillcalculatethevolumefortheothermedicationusingthetotalvolumeinjected.5. Press“Save”.AddingManualInjection(forPaperAnesthesiaRecords)TheTabletcomputerprovidesthemeanstodocumentIVinjectionsgivenpriortoactivatinganIntelliportdeviceorgiventhroughanIVportotherthantheIntelliportdevice.(ICU016)1. Pressthe“Add”button,thenpress“AddInjection”.TheFrequentUsemedicationlistwilldisplay.2. Highlightthedesiredmedicationandconcentration.Indicatethevolumeordose.3. Changethetimebypressingontheappropriatearrowstothecorrecttimeofadministration.4. Press“Save”andthemedicationwilllistinthemedicationhistoryareaattheindicatedtime.NOTEAmedicationadministrationtimecannotbeinthefuturenormorethanonehourbeforethefirstIntelliportdevicehasbeenactivated.AddingInfusions(forPaperAnesthesiaRecords)TheTabletcomputerprovidesthemeanstodocumentinfusions.1. PresstheAddbutton,thenpress“AddInfusion.”2. TheInfusionmedicationlistwilldisplayhavingfourcategories:Fluids,Medications,TitratableMedications,andBloodProducts.Selecttheappropriatecategory.
44Figure 25 Add Infusion 3. Selecttheappropriateinfusion,bagsizeandconcentration.Press”Save”.4. Specifyatimepoint.Tochangethetime,pressthearrowsofthehourandminutesuptoincreaseanddowntodecrease.Figure 26 Modify Infusion NOTEAmedicationadministrationtimeforaninfusioncannotbeinthefuturenormorethanonehourbeforethefirstIntelliportdevicewasactivated.5. Specifytheamountinfusedasofthattime(Optional).6. Press“Save”.Acliniciancanaddthevolumeinfusedforacareareaatanypointduringacasebypressingontheinfusionbar,enteringvolumeinfusedandpress“SAVE”.Tostopaninfusion,pressthe“Stop”buttonandpress“Save”.Inactiveinfusionswilldisplayablackbarandthetimetheinfusionwasstopped.
45AddingaComment(forPaperAnesthesiaRecords)Acommentisafreetextentrythatisrelevanttotheanesthesiarecord.TheTabletcomputersupportsfourmethodstoaddtoacomment: Allergies–commentsforaspecificdrugallergy.Tomakeacommentontheallergypop‐upscreen,highlighttheallergymedication,thenpress“Comment”button.Thiswillautomaticallydisplayakeyboardalongwithstandardcommentoptions.Thecliniciancanpressoneofthestandardoptionsortypeacommentandpress“Save”.Therecordedcommentisdisplayedwitheachallergypop‐up.(Theallergypop‐upscreenisdisplayedonPatientSetuporbypressingthe“Allergies”buttoninthelowerrightcorner.) Time–commentstiedtoaspecifictimeduringacase.Toaddageneralcommentforacase,pressthe“Comment”buttonandakeyboardwillpop‐up.Typethecommentandpress“Save”.Therecordedcommentdisplaywheneveryoupress“Comment”buttonandwillbelistedasa“CaseComment”intheclinicalreport. Injections–commentforaspecificdrugadministration.Tomakeacommentaboutaninjection,pressamedicationadministrationeventinthemedicationhistory.Thiswilldisplaythe“ModifySelectedInjection”pop‐up.Pressthe“Comment”buttoninthepopuptodisplayakeyboard.Typethecommentandpress“Save”.Thiscommentwilldisplaynearthedose/timewhenthecommentwaswritten. Infusions–commentforaspecificdrugadministration.Tomakeacommentonaninfusion,pressaninfusionevent.Thiswilldisplaythe“ModifySelectedInfusion”pop‐upscreen.Pressthe“Comment”buttontodisplaythekeyboardtotypeacomment.Typethecommentandpress“Save”.Thiscommentwilldisplaynexttotheinfusionevent.Figure 27 Add Comment TransferPatientsfromOneCareAreatoAnotherItisimportanttopreparethepatientandTabletcomputerpriortomovingthepatientfromonecareareatoanother.Pressing“PauseCase”fromtheMenuinstructstheTabletcomputertodisconnecttheIntelliportdevicetherebyenablinganotherTabletcomputerinasubsequentcareareatoconnecttoit.TheIntelliportdevicewillremainwirelesslyconnectedtotheearliertabletif“PauseCase”hasnotbeenpressedandthepatienthasbeenmovedtoasubsequentcarelocationthatiswithin30feetoftheearlierTabletcomputer.Inthissituation,thecliniciancandisconnecttheIntelliportbypressing“ShowAll”fromthePatientSetupscreenandfollowingthescreeninstructions.
46WorkingwithOrdersTheAnesthesiaSystemsupportsmedicationordersathospitalsthatuseComputerizedPhysicianOrderEntry(CPOE).WheninjectionsaregiveninperioperativenursingcareareasthatuseCPOE,theTabletcomputercanmatchtheinjectiontoaphysicianorderandsendthisinformationtothehospital’sclinicalinformationsystem.ObservethefollowingstepswhentheAnesthesiaSystemisconfiguredformedicationordersinthenursingcareareas:1. Reviewthepatient’smedicationorderattheclinicalinformationsystem.2. PreparethesyringeandIntelliportdeviceforuse.3. AttachthesyringeforthemedicationordertotheIntelliportdevice.Foranencodedsyringe,theTabletcomputercomparesthemedicationintheattachedsyringetopendingmedicationordersanddisplaysapopupconfirmingamatch.Verifythemedicationordermatches.Ifcorrect,press“Select”.Ifincorrect,press“SelectOther”.Figure28MedicationOrdersForanunencodedsyringe,theTabletcomputerdisplaysapopuplistingtheactivemedicationordersforthepatientandpromptsthecliniciantoselectthemedicationcorrespondingtotheattachedsyringe.HighlightthemedicationorderandpressSave.
47Figure29SelectinganOrderwhenUsingUnencodedSyringesRespondingtoMessagesTheAnesthesiaSystemprovidestwotypesofmessages:"System"and"Clinical.”"Clinical"messagesare“alertsandreminders”thatrelatedirectlytoanaspectofpatientcaredelivery(e.g.contraindicationorareminderthatitmaybetimetore‐doseantibiotics).Systemmessagesprovidestatusonrelevantsystemoperatingparameters.Messagesprovideinstructionsandabuttonforacknowledgingorresolving.RefertoAppendixXforalistofmessages.MessagesdisplayintheMessagesectionoftheTabletcomputeruntiltheyareacknowledgedorarenolongerclinicallyrelevant.Messagescanbeansweredanytimeduringacase.Priortopausingorclosingacase,aclinicianispromptedtorespond/answerunresolvedmedicationmessagesgeneratedduringthecase.ClinicalMessages Allergyalert‐Anallergyalertdisplayswhenaclinicianattachesanencodedsyringeorselectsamedicationforanunencodedsyringetowhichthepatienthasaknownallergy. Antibioticredosingreminder‐TheTabletcomputertrackselapsedtimesinceanantibioticisadministeredanddisplaysanantibioticredosingmessageiftheconfiguredredosingintervalhaselapsed.Theredosingintervalisindividualtoeachantibiotic,anditisconfiguredinthedruglibrary. Medication‐TheTabletcomputertracksmedicationsgiventhatarereconstituted,dilutedorgivenascocktails,(mixedmeds)anddisplaysamessageforthecliniciantospecify.Themessageisindividualtoeachmedication,anditisconfiguredinthedruglibrary.
48ReviewingtheMedicationRecord(forPaperAnesthesiaRecords)TheAnesthesiaSystemrequiresthecliniciantoreviewthemedicationrecordforaccuracypriortoprintingareport.Thisiscalled“finalizing”anditensurestheaccuracyofthereport.NOTEAclinicianisabletocorrectandamend(addinginformationto)thepatient’sthemedicationrecordsolongasanIntelliportforthatpatientisconnectedandthecasehasnotyetbeen“finalized”.1. FromthemainMenu,Press“Reports”.2. TheTabletcomputerwillprovideapopupwithmessagesforacliniciantoverifyoradjustthefollowingdata: Checkforreconstituted,dilutedormixedmedicationsgiven.Amessageisindividualtoeachmedication,anditisconfiguredinthedruglibrary. Checkformissinginfusiondata Checkformedicationsgiveninnursingareasbyananesthetistthataretobechartedintheanesthesiarecord Clockadjustment‐Press“Clock”toadjustthetimefortheprintedreportstosynchronizeananesthetistclockwiththeflowsheet.Apopupdisplaysshowingaclockwithupanddownarrowsforhoursandminuteadjustment.Press“Save”Figure30ReviewCase3. Ifthereareunresolvedmessages,thecliniciancancomebackandanswerthequestionsatanytimepriortoClosingthecase(CloseCase).4. Press“ReviewedCaseandPrint”.Oncefinalized,themedicationadministrationhistoryforrecordedmedicationadministrationswillnolongerbeeditable.Ifallquestionsarenotansweredpriortocaseclosure,thecliniciancancomebackandanswerthequestionsupto24hoursafterthecaseisclosed.Ifthe24hourwindowisexceeded,thecasecanonly
49beprintedoutandchangesmanuallymadewithapen,signedanddatedbytheclinicianandsubmittedtoMedicalRecordstobeattachedtothepatient’selectronicrecord.PrintingaReport(forPaperAnesthesiaRecords)Thefollowingreportsareavailableforprinting: AnesthesiaFlowSheetRecord–ThisreportlistsofthemedicationsandinfusionsprovidedduringtheORsuiteinaflowsheetformat.ThisiscomparabletotheAnesthesiaRecordthatismanuallyrecordedbyanesthesiologistsforallcases. ControlledSubstanceUsage‐ThisreportprovidesalistofallcontrolleddrugsusedduringtheORcase,withdoseamount,mLsusedandtimegiven. Handoff–Thisreportisusedasacommunicationtooltoconveyinformationpertinenttotheongoingcareofthepatient,especiallywhenthepatienttransfersfromonecareareatoanotherandanewprimarycaregiverassumescareofthepatient. PerioperativeMedicationAdministration‐Thisreportlistseachmedicationandfluidadministeredshowingthetime,dosageandroute.Italsoprovidesasummaryshowingtotaldosagebymediationandfluid.1. Toprintareport,pressReportsfromtheMenu.Figure 31 Print Reports 2. Selecttheappropriatereporttoprint.3. Specifytheprinter,ifdifferentfromdefault,andthenumberofcopies.4. PressPrint.AddressPendingMedications(EMRIntegration)WhenconfiguredforEMRintegration,theTabletcomputersendsmedicationadministrationinformationinrealtimeunlessinformationismissing.Themissinginformationincludesthedrugname/concentrationofanunencodedsyringe,thedoseofareconstituteddrug,oruseofacocktail.In
50thesesituations,theTabletcomputerretainsthismedicationadministrationinapendinglistuntilitisresolvedbytheclinician.NOTEItisgoodpracticetoresolvemedicationadministrationspriortoacaretransitionorclosingacase.(IFU032)5. FromtheMenu,press“PendingMeds”.Apop‐uplistsmedicationadministrationsthatrequireresolution.6. Presseachitemtoresolve.Aseachresolutiononmedicationoccurs,thequerywilldisappearandaresultingmedicationmessagewillindicatetheinformationsenttotheAnesthesiaInformationManagementSystem(AIMS)system.DeactivateIntelliport,DisposeofIntelliportSensor,andPrepareIntelliportBaseforReuse1. WhentheIntelliportdeviceisnolongerinuse;disconnecttheIntelliportSensorfromtheIntelliportBasebysqueezingtogetherthetwofingertabsontopoftheIntelliportSensorwhileliftinguptodisengagefromtheIntelliportBase.2. Whenproperlyseparated,theIntelliportdevicewillpoweroffandnolongertransmitswirelesslytoaTabletcomputer.3. DisposeoftheIntelliportSensoraccordingtoyourhospital’smedicalwasteprotocols.NOTEAvoidinadvertentlydiscardingtheIntelliportBaseafteruse.Itisintendedforreusewithmultiplepatients.4. CleananddisinfecttheIntelliportBase.Firstcleanitwithacommercialhospitaldisinfectantandsecondly,disinfectitsecondlywithacommercialhospitaldisinfectant.Followmanufacturer’sinstructions.Foralistofapprovedhospitalapprovedproductstouse,refertoAppendixX.5. Allowittodry.6. InspecttheIntelliportBaseforcracksordamage.Ifdamageisevident,thendisposeofitaccordingtoyourhospital’sprotocols.7. ConnecttheIntelliportBasetotheRecharger.NOTEIttakesapproximately2‐4hourstofullyrechargeanIntelliportBasewhendischargedto<25%ofpower.8. IftheIntelliportBasehasexceededitsUsefulLife,thendisposeofitaccordingtoyourhospital’sprotocolsforelectricalwaste.TheIntelliportBasecontainsaLithiumbattery.NOTETheIntelliportBasewillilluminatearedlightwhilechargingifithasexceededitsUsefulLife.PowerDowntheTabletcomputerTheTabletcomputermayremainpowereddownbetweenuses.1. ConfirmtheTabletcomputerdoesnothaveIntelliportdevicesconnectedanditisnolongerinuse.2. Pressthe“Shutdown”buttonlocatedontheMenubar.
513. Press“Yes”,toconfirmandpowerdowntheTabletcomputer.
52SectionVTroubleshootingIntheeventyouexperiencedifficultyoperatingtheAnesthesiaSystem,thissectionofthemanualprovidesatroubleshootingguideforoperationalproblems.Iftheresponsetoaspecificquestionisnotfound,contactyourServiceRepresentative:Phone:Website:Email:QuestionAnswerHowdoIreturntotheClinicalMainScreenorHome?FromMainMenupress“Anesthesia”or“Nursing”view.WhatdoIdoiftheBatteryintheBaserunsoutofchargeduringacase?ABasecanbeexchangedatanytimewithoutaffectingthecase.Exchangestakelessthan30seconds.Ifitismorethan30seconds,thecasewillrequireresynchronizationofIntelliportdevicetoTabletcomputer.WhatifIpressed“CloseCase”or“Shutdown”bymistakeduringanactivecase?OnceyouresynchronizethepatientandIntelliportdevicetotheTabletcomputer,allinformationisretrievable,eveniftheIntelliportSensorisreplaced.Whatcausesmetolosehistoricalmedicationinformation?AndwhatcanIdotoretrieveit?ItisnotpossibletolosehistoricalmedicationinformationiftheIntelliportdeviceandpatienthavebeensynchronizedtotheTabletcomputer.MedicationsgivenpriortoIntelliportsynchronizationareretainedinmemoryontheIntelliportBase.WhatifIforgottochartamedicationoridentifya“SelectMed”andthepatientisnowintheMed‐SurgfloororICU?Ifithasnotbeenmorethan24hourssincetheORcase,thecasecanberetrievedfromthehospitalserverandeditingofthecasecanoccurviaaTabletcomputer.However,ifgreaterthan24hours,thecasereportcanbeprinted,andmanualeditsmadewithdatesandsignaturesandreturnedtoMedicalRecordsforacaseupdate.WhatdoIdoiftheIntelliportSensornolongerisworkingandthecaseisnotover?AnIntelliportSensorcanbereplacedatanytime.Resynchronizationisrequired.WhatifthecaseisoverandIjustnoticedthewrongpatientappearsonthescreen?GotoMainmenuandpressthe“RemovePatient”button.TBD.
53SectionVICareandMaintenanceObservethefollowingproceduresforcareoftheAnesthesiaSystem.ComponentsoftheAnesthesiaSystemdonotrequireusermaintenance.Therearenouserserviceableparts.CareCleanandDisinfecttheIntelliportBaseforReuse1. CleantheIntelliportBasewithacommercialhospitaldisinfectant.ThendisinfecttheIntelliportBasewithacommercialhospitaldisinfectant.(IFU0024)ForalistofapprovedhospitalcleaningproductstouseontheIntelliportBase,pleaserefertoAppendixB.2. Allowittodry.3. InspecttheIntelliportBaseforcracksordamage.Ifdamageisevident,thendisposeofitaccordingtoyourhospital’sprotocols.RechargingtheIntelliportBaseforReuse4. PlugtheRechargerintoanisolatedACoutlet.5. AttachtheRechargertoacleananddisinfectedIntelliportBasebyjoiningtheRechargerandIntelliportBasefrontsectionsfirst,thensnapthetwotogether.Oneshouldaudiblyhearthe“snap”.6. VerifyproperseatingofRechargertotheIntelliportBasebycheckingfora“charging”lightontheIntelliportBase.Ifthisisnotseen,viewtheIntelliportdeviceonitssidetodetermineifthetwoareproperlyconnected.IfaspaceisseenbetweentheRechargerandIntelliportBase,thenseparateandre‐attachedproperly.7. TheIntelliportBasewillilluminateshowingtheamountofchargeinthebattery.Refertothefollowingsectionshouldaredindicatorlightilluminate.NOTEFourbarsindicateafullcharge.TheIntelliportBaseisnotdamagedwhenleftontheRechargerafterbeingfullycharged.CleananddisinfecttheRechargerbyusingtheprocedureusedfortheIntelliportBase.DeterminingUsefulLifeforaIntelliportBaseTheIntelliportBaseisdesignedtobereusable.After500uses,thecomponentsmaybesusceptibletowearanditisnolongersuitableforusewithpatients.UsethefollowingproceduretodetermineifanIntelliportBasehasexceededitsusefulLife.NOTEAvoidusinganIntelliportBasethathasexceededitsUsefulLife.1. ConnecttheIntelliportBasetoaRecharger.2. IftheIntelliportBasehasexceededitsUsefulLife,thentheIntelliportBasewillilluminatearedlightwhilecharging.Ifso,discontinueuse.NOTEIfanIntelliportBasehasexceededitsUsefulLife,thendisposeofitaccordingtoyourhospital’sprotocolsforelectricalwaste.TheIntelliportBasecontainsaLithiumbattery.
54ShouldanIntelliportBasebeusedafterithasexceededitsUsefulLife,amessagewilldisplaywhentheIntelliportdeviceiswirelesslyconnectedtotheTabletcomputerduringPatientSetup.Shouldyouexperiencethismessage,replacetheIntelliportBasewithanotherandrepeatthewirelessconnectiontotheTabletcomputer.CleaningtheTabletcomputer1. TurntheTabletcomputeroffanddisconnectthepowercable.2. CleantheTabletcomputerwithasoftclothdampenedwithwater.Moistenasoft,lint‐freeclothwitheitherwateroradisplaycleaner,andwipethesurfaceoftheTabletcomputeruntilitisclean.Donotuseaerosolcleaners,whichmaycontainflammablesubstances.DonotallowwaterfromtheclothtoseepdowntotheTabletcomputerportsandthebuttons.ToavoiddamagingtheTabletcomputerordisplay,donotspraycleaningsolutiondirectlyontothedisplay.OnlyuseproductsspecificallydesignedforcleaningTabletcomputers,andfollowthemanufacturer’sinstructionsthatareincludedwiththeproduct.ForalistofapprovedhospitalcleaningproductstouseonyourTabletcomputer,pleaserefertoAppendixF.StorageComponentsoftheAnesthesiaSystemdonotrequireusermaintenance.Therearenouserserviceableparts.ContactTechnicalSupportintheeventaTabletcomputerorIntelliportBaseisnotfunctioningproperly.TabletcomputerWhennotinuse,theTabletcomputermayremainmountedandpoweredon,whenconnectedtoanisolatedACpowersource.NOTEDonotremovetheTabletcomputerfromitsprotectivecaseforstorage.IntelliportBaseWhennotinuse,acleananddisinfectedIntelliportBaseshouldremainontheCharger.NOTEDonotplaceanIntelliportBaseinstoragewithoutfirstcleaninganddisinfectingaccordingtoHospitalpolicy.NOTEForhospitalsthatkeepaspareIntelliportBaseintheOR,besuretoperiodicallyswapoutIntelliportBasetoensureitisfullycharged.
55IntelliportSensorIntelliportSensorsarestoredinthesterilepackaging.IntelliportSensorshavea“UseBy”datetoensuresterility.DiscardIntelliportSensorsthathavenotbeenusedbytheirUseBydate.MaintenanceComponentsoftheAnesthesiaSystemdonotrequireusermaintenance.Therearenouserserviceableparts.ContactTechnicalSupportintheeventaTabletcomputerorIntelliportBaseisnotfunctioningproperly.AdministrationandServiceToBeDetermined
56SectionXIII.AppendixAppendixAIntelliportTechnicalSpecificationsSpecificationDescriptionFluidconnection2ports,LuerlocktypefittingsVolumemeasurementaccuracy±5%Injectionportcapacity100injectionsPrimevolume5mLDeadvolume/retainedfluid0.3mLfollowinginjectionExteriorsize(excludingtubing)<4.5cubicinchesWeight72gm(IntelliportBaseandIntelliportSensor)OperationonaSinglecharge24hoursRechargespeedUpto4hoursfrom<25%Wirelessrange(Intelliportdevice)5mOperatingTemperature12˚C‐40˚C(IFU014)OperatingHumidity20%to85%relativehumidity(IFU015)ShippingandStorageTemperature‐20˚C‐60˚CShippingandStorageHumidity15%to90%relativehumidity
57AppendixBDisinfectantAgentsThefollowingdisinfectantsaresuitableforusewiththeIntelliportBaseandRecharger.DisinfectantTypeofdisinfectantCaviWipes1(ByMetrex)Alcohol‐basedquaternaryammoniumSuperSaniCloth(purpletop)(byPDI)Alcohol‐basedquaternaryammonium
58AppendixCStandardsTheAnesthesiaSystemisintendedforuseunderthesupervisionofhealthcareprofessionalsonly.ThisisaClassIImedicaldevice.TheAnesthesiaSystemconformstothefollowingstandards.IEC60601‐1MedicalElectricalEquipment‐Part1.GeneralRequirementsforSafetyIEC60601‐1‐2CollateralStandard:Electromagneticcompatibility‐Requirementsandtesting
59AppendixDGlossaryThefollowingtermsareusedintheseInstructionsforUse.ConfigurationThewaytheAnesthesiaSystemissetup,ortheassortmentofcomponentsthatmakeuptheAnesthesiaSystem.TheGatewaymanagestheconfigurationsettings.AllTabletComputersforacareareahavethesamesettings,exceptforwirelessandprinters.EMRintegratedmodeSystemconfigurationthatsupportsintegrationwithelectronicmedicalrecordsorperioperativeinformationmanagementsystems(PIMS)EncodedSyringesSyringeshavingaspecialbarcodeidentifieronthetipEncodingAspecialbarcodeidentifieronthetipofprefilledsyringesGatewayAsoftwareapplicationthatenablestheAnesthesiaSystemtofunctionasanenterprisedeviceandinformationsystem.TheGatewayprovidesacentralhubtowhichallTabletcomputersconnectviathehospitalnetwork.ItalsoincludesaninterfaceenginefortheAnesthesiaSystemtoexchangedatawithothernetworkedhospitalinformationsystems,alongwithasuiteofutilitiesforgeneralGatewayimplementation,operation,andmaintenance.InjectionportThesplitseptumportontheIntelliportSensorwherethesyringeattachesIntelliportBaseTheIntelliportBaseisanon‐sterile,reusabledevicethathousestheelectronicsandwirelesstransmitter.Itisbatterypowered,andrechargeable.AseparateChargerrechargesthebatteryinthereusableIntelliportBasepriortoeachuse.IntelliportdeviceAnintelligentinjectionport.Itattachestoaninjectionsite(“YSite”orstopcock)formanuallyadministeredIVinjections.ItiscomprisedofaIntelliportSensorandaIntelliportBase,whichsnaptogetherpriortouse.IntelliportSensor AIntelliportSensorisasteriledisposabledevicehavinganinjectionportandaLuerconnection.TheIntelliportSensorissuppliedinasterilepackageforsinglepatientuse.Luer‐lok Astandardfittingusedformakingleak‐freeconnections.Aluerfittingthatsecurelylockstogetherusingthreads.Non‐encodedsyringesSyringesthatdonothavespecialencodingonthetip.TheIntelliportdevicecannotidentifythedrugcontentsofthistypeofsyringe.PerioperativeDrugLibraryTheAnesthesiaSystemoperatesusingthehospital’sperioperativedruglibrary.TheGatewaymanagesthedruglibrary.Whenanunencodedsyringeisattached,thepicklistisderivedfromtheperioperativedruglibrary.RechargerAseparateRechargerrechargesthebatteryinthereusableIntelliportBasepriortoeachuse.Stand‐alonemodeSystemconfigurationthatsupportsapaperanesthesiarecord
60TabletcomputerAcommercialTabletcomputerwithembeddedsoftwarefortheAnesthesiaSystemoperation.Itcontinuouslycapturesanddisplaysthemedicationadministrationrecord(MAR)datafromtheIntelliportdeviceeachtimeaninjectionoccurs.Italsoenablesclinicianstomanuallydocumentotherpertinentclinicalinformation,anditprovidesclinicaldecisionsupporttohelpimprovesafetyandaidcliniciansduringtreatment.InformationtechnologywirelesslytransfersthedatatotheGateway.
61AppendixEASADrugCategoryColorSchema 
62AppendixFMessagesName&TriggerMessageText ClearingtheMessage1.Tabletcomputersoftwareisunabletoverifyitsconfigurationsettings(e.g.nowirelesstoGateway)Softwareconfigurationorformularyversionscannotbeverified.Usingcurrentsettings.Notifyyoursystemadministrator.‐Persistswithbootupscreen.Willtimeoutin10seconds.2.WhiletheTabletcomputersoftwareisreceivingandupdatingtheTabletcomputersoftwareConfigurationProfile.UpdatingDPM,configurationtoversion[xx].‐Persistswhileupdatingfile(s)3WhiletheTabletcomputer softwareisreceivingandupdatingtheDrugFormulary.UpdatingFormularytoversion[xx].‐Persistswhileupdatingfile(s)4ConfigurationupdatenotsuccessfulNewconfigurationsettingsnotupdated.Usingcurrentsettings.Notifyyoursystemadministrator.‐Persistswithbootupscreen5IntelliportBase‐EndofLife‐Intelliportdevicetransmits#ofusesuponsynchronization.Intelliportdevicehasreacheditsendoflife‐OKclearsthemessage‐Confirm(completespatientassociation)6Drugconnectedorsubsequentlyidentifiedmatchesacontraindicateddrugbasedonthepatient’sallergyScreen‐“[Drugname]‐PotentialAllergyReaction”Patienthasaknownallergyto:[allergydescription]“Severity:”[severity]“Reaction:”[reaction]‐OKbutton‐Automaticallyuponsyringedisconnectifnotpushed.7Antibioticredosingintervalexceedsconfigurationvaluefortheantibiotic.[AntibioticDrugName]givenX.Xhoursago.Considerredosing.‐OKbutton‐Automaticallyuponsubsequentantibioticinjectionconnected/identified.8Thedrugconnectedorinjectedhasbeenidentifiedasfrequentlydilutedinconfiguration.“PressHereif[DrugName]wasdilutedbeforegiven.‐PressingtheDilutionmessagetextopensthemanualinjectionentryscreenwithvolumeanddosefieldseditable.9Thedrugconnectedorinjectedhasbeenidentifiedasfrequentlymixedinconfiguration.“PressHere”if[DrugName]wasmixedbeforegiven.‐PressingtheMixedmessagetextopensthemanualinjectionentry
63Name&TriggerMessageText ClearingtheMessagescreenwithfieldsforaseconddrug.10TabletcomputersoftwarereceivesunmeasuredinlieuofvolumefromtheIntelliportdevice“Amountinjectednotmeasured”.“PressHere”toenterthevolumegiven.‐PressingtheNotMeasuredmessagetextopensthemanualinjectionentryscreenwithcursorfocusonvolumefield.11IntelliportdevicetransmitsalowbatterymessageLowIntelliportbattery(10%remaining).ReplaceIntelliportBase.‐AutomaticallyuponIntelliportunsynchronizationorIntelliportBasereplacement.12IntelliportdevicetransmitsapoweringdownmessageLowIntelliportbattery.Intelliportdevicepowereddown.‐AutomaticallyuponsynchronizationofIntelliportdevicehavinglowbattery.13Tabletcomputerhaslessthan20minutesofpowerremainingLowTabletcomputerbattery.(10%remaining).‐AutomaticallywhenTabletcomputeronACpower14TabletcomputersoftwarepoweringdownmessageLowTabletcomputerbattery.Tabletcomputerpoweringdown.N/A15AnIntelliportdeviceisnolongercommunicatingwiththeTabletcomputersoftwareafter5secondsofpollingbytheTabletcomputersoftwareIntelliportwirelessconnectionlost.‐AutomaticallyuponIntelliportsynchronizationofsameserialnumberIntelliportSensor/IntelliportBase.16AnIntelliportdevicehasbeenconnectedcommunicatingwiththeTabletcomputersoftwareafterpollingbytheTabletcomputersoftware.Intelliportwirelessconnectionrestored.‐1minutetimeout.17IntelliporterrorconditiontransmittedtoTabletcomputersoftwareIntelliporterroroccurred.ReplaceIntelliportBase.‐Press”Clear”ifresolved18IntelliporterrorconditiontransmittedtoTabletcomputersoftwareTabletcomputererroroccurred.RestartTabletcomputer.‐OKbutton.‐Press“Clear”ifresolved19TabletcomputersoftwareerrorconditionpresentTabletcomputererroroccurred.RestartTabletcomputer‐OKbutton‐Press“Clear”ifresolved20UserpressesShutDownbuttonwithnoIntelliportdevicessynchronized.Tabletcomputershuttingdown.N/A
64Name&TriggerMessageText ClearingtheMessage21UserpressestheShutDownbuttonwhileanIntelliportdeviceissynchronized.ShutDowntheTabletcomputeranddisconnecttheIntelliportdevice?Yes–continuewithshutdownNo–cancelshutdown22UserpressesPrintbuttononReportingScreenPrintingtoXXXprinter.N/A23Failedlogin.UserNameandPasswordcombinationnotvalidTextprovidedbyGatewayor“IncorrectPassword.Re‐enter”.Nextloginattempt24DoseexceedsorderedDose“Checkdoseonorder”Syringeisdisconnected25IntelliportSensornotprimed.NoSensorsignalatinitialIntelliportSensorattachment“PrimeIntelliportSensorbeforeuse”IntelliportSensorsignallevelachieved.26AirdetectedintheIntelliportSensor.OccursafterproperprimingwithfluidandairentrappedintheIntelliportSensor.“AirdetectedintheIntelliportSensor”.IntelliportSensorsignallevelachieved.(returned)
65AppendixGAccessories Charger(partnumber2284)‐ThisaccessoryisusedtorechargetheIntelliportBaseinpreparationforreuse. Radio(partnumber2285)–ThisaccessoryisusedbytheTabletcomputertocommunicatewithIntelliportdevices.
66AppendixHRadioFrequencyWirelessTechnologyTherearetwowirelesstechnologiesusedintheAnesthesiaSystemasdepictedinFigureXbelow.HospitalWirelessNetworkGatewayIntelliportTabletComputer 802.11 - Clinical Data to/from Tablet to Gateway2.4 GHz. - Medication administration data to/from Intelliport to Tablet ComputerTheradiofrequency(RF)signalpowerhasbeenlimitedtoaverylowleveltonegateanyelectromagneticpotentialinterferenceinco‐existencewithothermedicaldevices.Bothwirelesstechnologiesutilizedhavebeenapprovedforusebythe(FederalCommunicationsCommission)FCCandmeetFederalEMCandEMIguidelines.IntheeventofapotentialsignallossoftheseRFcommunicationsa“lostwirelesslinkmessage”willbedisplayedontheTabletcomputertoinformtheoperator.TheTabletcomputerwillindicatewhencommunicationsareresumed.Informationonproperset‐up,configurationandperformancewiththeHospitalNetworkisprovidedattimeofsysteminstallation.Noset‐upisrequiredforIntelliportdevicetoTabletcomputercommunications.Confirmationofappropriatepatientidentificationisrequired.Othermedicalequipmentsuchasanelectrosurgicalunit(ESU)maybrieflyinterferewiththesewirelesscommunications.Communicationsshouldautomaticallyresumeaftertheinterferenceandlostmessageswillberesent.TheTabletcomputerwillindicatewhenlostcommunicationsexist.TheIntelliportstatusindicatorwilldoubleblinkwhencommunicationwiththeTabletcomputerislost.IntelliporttoTabletcomputerTheTabletcomputerusesanIntelliportRadiotowirelesslycommunicatewiththeIntelliportdeviceusinganRFsignalat2.4GHztoformalocalmedicaldevicenetwork.AnumberofIntelliportdevicesandTabletcomputersmaybeusedinthesamevicinitysuchasaPre‐operativecareareaoraPACU.AlicensehasbeenissuedbytheFederalCommunicationsCommission(FCC)tooperatethismedicaldeviceinhospitalsandclinics.TestinghasbeenperformedtodemonstrateconformancetoIEC60601‐1‐2forthecorrect,timelyandsecuretransmissionofmedicaldata(injecteddrugidentificationcodesandvolumemeasurements)andalertmessages.AlertmessagesarecommunicatedbetweentheIntelliportdeviceandtheTabletcomputertoadvisetheUserofvariousoperationalcharacteristicsofthesystem.Someofthesealertsinformtheoperatorofpotentialhazardoussituationstoallowuseractiontopreventharmtothepatientorlossofmedicaldata.Intelliportdevicesusingproprietary2.4GHztechnologyareassociated(linked)withspecificpatientsusingtheTabletcomputerIEEEstandardsbasedon802.11a/b/n(2.4GHz‐5GHz)technology.TheUseridentifiestheIntelliportSensorbyserialnumberandselectsaspecificpatientfromthehospital’spatient
67listing.AllmedicationadministrationdatafromtheIntelliportdeviceistransferredtothespecificpatient’smedicalrecord.Intheeventofacommunicationloss,medicationadministrationdatawillbestoredlocallyattheIntelliportdeviceandtransferredtotheTabletcomputerwhencommunicationsareresumed.TabletcomputertoGatewaythroughtheHospitalNetworkTheTabletcomputerwirelesslycommunicateswiththeexistingHospitalNetworkusingastandardsbasedIEEE802.11a/b/g/nenterpriseWLANnetwork.ThenetworkingtopologythatincludesthisTabletcomputerwillfollowthebestofpracticedeploymentguidelinesthatcomplieswiththerightqualityofservice(QoS)andsecurity.TheGatewaysoftwareandaccompanieddatabasewillbeapartofthehospital’senterpriseinformationsystem.AnumberofTabletcomputersmaybeconnectedtothehealthcareenterprisewirelessnetworkandtotheintendedGatewaysoftwareanddatabase.TheGatewayandaccompanieddatabaseprovidesalistofpatientsfortheUsertoselectandaFormularylibraryofmedicationsandfluidsforinjectionorinfusion.ActualmedicationandfluidadministrationdataissenttotheGatewayandaccompanieddatabaseforrecordkeeping.OncerecordedontheGatewayandaccompanieddatabasethisdataisautomaticallyavailableinothercareareaswhenthepatientistransferredandtheIntelliportdeviceiswirelesslyconnectedtoaTabletcomputer.SummaryofIEC60601‐1‐2TestingandSpecificationsSpecificationsIntelliporttoTabletcomputerTabletcomputertoHospitalNetworkandGatewayTechnologyType2.4GHzproprietarymessaging802.11ab,g,nsecurewirelessconnectionwiththecorrectqualityofservice(QoS)EffectivePower Effectivetransmissiondistance10metersorlessXxmeterstohospitalwirelessaccesspoint(WLANAP)DatathroughputandlatencyReal‐timeinformation,nodelaysSubjecttohospitalnetworkperformanceLostCommunicationsMessageontheTabletcomputerdisplay“Intelliportcommunicationlost”“Gatewaycommunicationlost”Limitations3IntelliportdevicestooneTabletcomputer200TabletcomputerstoHospitalNetworkandGatewayFCCLicense########LimitationsfoundduringtestingtoIEC60601‐1‐2XxxxNottested–conformstoIEEE802.11standards.
68QualityofService WirelessCoexistence Securityofwirelesssignal/dataEMCinformation 
69AppendixIReferenceDocumentsAvailabledocumentationandtrainingfortheAnesthesiaSystemincludes:OrderNumberDocumentName2300AnesthesiaSystemInstructionsforUseXXXXXAnesthesiaSystemQuickReferenceCardsXXXXXUserTrainingVideoandDVD
70AppendixJDescriptionofSymbolsThefollowingsymbolsareusedbytheAnesthesiaSystem.SymbolDescriptionWarningsIPX2 IngressProtectionfromfallingwaterdropsRefertouseroperatinginstructionsDonotuseifpackageisdamagedorprotectorcapisunattached.TypeBF/DefibrillationProofappliedpartSingleUseOnly.Donotreuse!IdentifiesthecomponentmanufacturerKeepdryUppertemperaturelimitExpirationDate,endofshelflifeDecember,2013LotnumberSterileEOSuppliedSterile,EthyleneOxidegas
71BectonDickinson1BectonDriveFranklinLakes,NJ07417Phone:(xxx)xxx‐xxxxFax:(xxx)xxx‐xxxxRevisionDate:2/21/2013PartNo.: 2300_R1FCC‐IC

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