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User manual | Users Manual | 2.52 MiB | June 03 2014 | |||
1 | Cover Letter(s) | June 03 2014 | ||||||
1 | External Photos | June 03 2014 | ||||||
1 | Internal Photos | June 03 2014 | ||||||
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1 | Test Report | June 03 2014 |
1 | User manual | Users Manual | 2.52 MiB | June 03 2014 |
BDAnesthesiaSystem InstructionsforUseManual InjectingConfidence 1 ADDLIMITEDWARRANTYANDDISCLAIMERHERE Thisdocumentcontainsconfidentialinformation.Nopartofthisdocumentmaybetransmitted, reproduced,used,ordisclosedoutsideofthereceivingorganizationwithoutthewrittenconsent ofBectonDickinsonandCompany. IntelliportandinjectingconfidencearetrademarksofCRISIMedicalSystems,Inc. BD,BDLogo,andLuerLokaretrademarksofBectonDickinsonandCompany. CaviWipes1andSuperSaniCloth,aretrademarksoftheirrespectivemanufacturers. ProtectedbyoneormoreofU.S.PatentNos.8,394,053,8,355,753,8,385,972,8,328,082. Otherpatentspending. 2014BectonDickinsonandCompany 2 TableofContents SECTIONIBACKGROUND.....................................................................................................................8 Introduction..............................................................................................................................................8 ProductDescription..................................................................................................................................8 HowitWorks...........................................................................................................................................10 IndicationsforUse..................................................................................................................................11 IntendedUse...........................................................................................................................................11 SECTIONIISAFETYPRECAUTIONS......................................................................................................12 WarningsandPrecautions......................................................................................................................12 General................................................................................................................................................12 TabletcomputerTabletcomputerTabletcomputer...............................Error!Bookmarknotdefined. Tabletcomputer.................................................................................................................................13 Intelliportdevice.................................................................................................................................14 SECTIONIIIDESCRIPTIONOFANESTHESIASYSTEMCOMPONENTS.....................................................17 SuppliesandEquipment.........................................................................................................................17 Intelliport................................................................................................................................................17 IntelliportSensor................................................................................................................................17 IntelliportBase....................................................................................................................................18 Recharger................................................................................................................................................19 EncodedSyringes....................................................................................................................................19 Tabletcomputer.....................................................................................................................................20 SoftwareRunninginStandaloneMode..................................................................................................20 AnesthesiaView..................................................................................................................................21 NursingView.......................................................................................................................................23 ButtonandMenuOptions..................................................................................................................24 SoftwareRunninginEMRIntegratedMode...........................................................................................27 SECTIONIVOPERATIONS...................................................................................................................30 QuickGuide.............................................................................................................................................30 PreparetheIntelliport........................................................................................................................30 SetuptheTabletcomputer................................................................................................................30 GiveIVinjectionsandViewMedicationAdministrations...................................................................31 3 DetailedOperatingInstructions..............................................................................................................32 PreparetheIntelliport........................................................................................................................32 SetuptheTabletcomputerPaperAnesthesiaRecord.....................................................................32 GiveanIVinjectionUsingtheIntelliportDevice................................................................................37 SpecialActivities.....................................................................................................................................39 SettingUserPreferences....................................................................................................................39 AddingAdditionalIntelliports.............................................................................................................39 MedicationDeliverywithSyringesNotEncoded................................................................................40 SpecifyingaDilutedorReconstitutedMedication.............................................................................41 SpecifyingaMixedMedication(Cocktail)...........................................................................................42 AddingManualInjection(forPaperAnesthesiaRecords)..................................................................43 AddingInfusions(forPaperAnesthesiaRecords)...............................................................................43 AddingaComment(forPaperAnesthesiaRecords)..........................................................................45 TransferPatientsfromOneCareAreatoAnother.............................................................................45 WorkingwithOrders...........................................................................................................................46 RespondingtoMessages....................................................................................................................47 ReviewingtheMedicationRecord(forPaperAnesthesiaRecords)..................................................48 PrintingaReport(forPaperAnesthesiaRecords)..............................................................................49 AddressPendingMedications(EMRIntegration)...............................................................................49 DeactivateIntelliport,DisposeofIntelliportSensor,andPrepareIntelliportBaseforReuse...........50 PowerDowntheTabletcomputer......................................................................................................50 SECTIONVTROUBLESHOOTING.........................................................................................................52 SECTIONVICAREANDMAINTENANCE...............................................................................................53 Care.........................................................................................................................................................53 CleanandDisinfecttheIntelliportBaseforReuse.............................................................................53 RechargingtheIntelliportBaseforReuse..........................................................................................53 DeterminingUsefulLifeforaIntelliportBase....................................................................................53 CleaningtheTabletcomputer............................................................................................................54 Storage....................................................................................................................................................54 Tabletcomputer.................................................................................................................................54 IntelliportBase....................................................................................................................................54 IntelliportSensor................................................................................................................................55 4 Maintenance...........................................................................................................................................55 AdministrationandService.....................................................................................................................55 SECTIONXIII.APPENDIX....................................................................................................................56 AppendixAIntelliportTechnicalSpecifications......................................................................................56 AppendixBDisinfectantAgents..............................................................................................................57 AppendixCStandards.............................................................................................................................58 AppendixDGlossary...............................................................................................................................59 AppendixEASADrugCategoryColorSchema........................................................................................61 AppendixFMessages..............................................................................................................................62 AppendixGAccessories..........................................................................................................................65 AppendixHRadioFrequencyWirelessTechnology................................................................................66 AppendixIReferenceDocuments..........................................................................................................69 AppendixJDescriptionofSymbols.........................................................................................................70 5 TableofFigures Figure1AnesthesiaSystemComponents.....................................................................................................8 Figure2IntelliportDevice.............................................................................................................................9 Figure3IntelliportSensorwithlast4digitsoftheSerialNumber.............................................................17 Figure5EncodedSyringeAttachment........................................................................................................20 Figure7StandAloneMode........................................................................................................................21 Figure8AnesthesiaView............................................................................................................................22 Figure9UnitTotal.......................................................................................................................................23 Figure10NursingView...............................................................................................................................24 Figure11EMRIntegratedMode.................................................................................................................27 Figure12EMRIntegrated(CompanionView)............................................................................................28 Figure14Login............................................................................................................................................33 Figure15ConnectinganIntelliport............................................................................................................34 Figure16PatientSetup...............................................................................................................................35 Figure17ADTPatientList...........................................................................................................................35 Figure18ConfirmPatientAssociation........................................................................................................36 Figure19PatientAllergies..........................................................................................................................36 Figure20UserPreferences.........................................................................................................................39 Figure21ConnectingAdditionalIntelliports..............................................................................................40 Figure22SelectMedication.......................................................................................................................41 Figure23ModifySelectedMedication.......................................................................................................42 Figure24CocktailMedication....................................................................................................................43 Figure25AddInfusion................................................................................................................................44 Figure26ModifyInfusion...........................................................................................................................44 Figure27AddComment.............................................................................................................................45 Figure28MedicationOrders......................................................................................................................46 Figure30ReviewCase................................................................................................................................48 6 Importantinformationishighlightedbytheseiconsandterms:
WARNINGindicatesapotentialforpersonalinjuryordeath. CAUTIONindicateseitherpotentialdamagetothehardwareorlossofdataand instructshowtoavoidtheproblem. NOTE NOTEindicatesimportantinformationtomakebetteruseoftheAnesthesiaSystem. 7 Section I Background Introduction ThankyouforchoosingtheBDAnesthesiaSystem(AnesthesiaSystem).TheAnesthesiaSystemcanbe usedwhenintravenousbolusinjectionsofmedicationaregiventoapatientbyanurseoranesthetistfor automateddocumentationofmedication,concentration,dose,volumeandtimeofeachIVinjection duringanoperation,recoveryandproceduralevent. Duringtreatment,theclinicianconnectsanintelligentinjectionport,calledtheIntelliportdevice,toa patient'sfluiddeliverylineandperformsstandarddrugdeliveryactivities.TheIntelliportdevice automaticallycapturesinformationaboutdrugsinjected,andwirelesslytransmitsthatinformationin realtimetotheTabletcomputer.TheTabletcomputerusesthatinformationandothermanually enteredinformationtodisplayatimestampedmedicationrecord.Itprovidestheclinicianwithclinical decisionsupport.Italsomakesthatinformationavailableforreportingandelectronicrecordkeeping purposes. TheAnesthesiaSystemhastwooperatingmodes.Thefirstconfigurationisastandalonesystemthat supportsapaperanesthesiarecord.Thesecondconfigurationinvolvesintegrationwithelectronic medicalrecordsorperioperativeinformationmanagementsystems(PIMS). Thisguideprovidesinstructionsforthesafeandproperoperationofthedevice,aswellassetup, configuration,andcareinformation.Readthisentiremanualcarefullyandfamiliarizeyourselfwiththe featuresandoperationoftheAnesthesiaSystempriortouse. ProductDescription TherearefourcomponentstotheAnesthesiaSystem:
Encoded Syringes Intelliport Device Figure 1 Anesthesia System Components Tablet computer Gateway 8 Intelliportdeviceisanintelligentinjectionport.Itattachestoaninjectionsite(YSiteorstopcock)for manuallyadministeredIVinjections.ItiscomprisedofaSensorandaBase,whichsnaptogetherpriorto use.TheIntelliportSensorisasteriledisposablehavinganinjectionportandaLuerconnection.The IntelliportSensorissuppliedinasterilepackageforsinglepatientuse.TheIntelliportBaseisanon sterile,reusabledevicethathousestheelectronicsandwirelesstransmitter.Itisbatterypowered,and rechargeable.AseparateRechargerrechargesabatteryinthereusableIntelliportBasepriortoeach use. IntelliportBase IntelliportSensor Figure2IntelliportDevice EncodedSyringesarecommerciallyavailabledrugsinprefilledsyringeswithaspecialidentifier,called encoding,thatstoresinformationaboutthemedicationcontainedwithinthesyringe.Encoded syringesarereadytouse,passiveanddisposable.TheAnesthesiaSystemalsoaccommodatessyringes nothavingencoding. TabletComputerrunstheAnesthesiaSystemsoftware.Itcontinuouslycapturesanddisplaysthe medicationadministrationrecord(MAR)datafromtheIntelliportdeviceeachtimeaninjectionoccurs. Italsoenablesclinicianstomanuallydocumentotherpertinentclinicalinformation,anditprovides clinicaldecisionsupporttohelpimprovesafetyandaidcliniciansduringtreatment. GatewayissoftwarethatenablestheAnesthesiaSystemtofunctionasanenterprisedeviceand informationsystem.TheGatewayprovidesacentralhubtowhichallTabletcomputersconnectviathe hospitalnetwork.ItalsoincludesaninterfaceenginefortheAnesthesiaSystemtoexchangedatawith othernetworkedhospitalinformationsystems,alongwithasuiteofutilitiesforgeneralGateway implementation,operation,andmaintenance. TheGatewayincludesabrowserbaseduserinterfaceforadministratorsoftheAnesthesiaSystemto configurethedevicelibraryandTabletcomputerdefaultsettings. 9 HowitWorks ThemedicationadministrationprocessusingtheAnesthesiaSystemisillustratedinFigureXXX.Priorto treatment,theclinicianprimesandconnectstheIntelliportdevicetothepatientscatheterorinjection port(ysite).Duringmedicationadministration,theclinicianperformsstandarddrugdeliveryofbolus medications. Whenasyringeisattachedtotheinjectionport,theIntelliportdeviceidentifiesthemedicationand concentrationforanencodedsyringebyopticallyimaginganddecodingabarcodeonthetipofthe syringe.ThisinformationiswirelesslytransmittedtotheTabletcomputer,andtheTabletcomputer displaysandannouncesthedrugattached.Italsomayperformsafetychecks. Asdrugispushed,theIntelliportdevicemeasuresthevolumedosedultrasonically.TheIntelliport devicewirelesslysendsvolumemeasurementinformationtotheTabletcomputer.TheTabletcomputer usesthisinformationtoprovideclinicianswithclinicalinformation.Themedicationadministration informationistimestampedanddisplaysforclinicalreferenceduringsurgicalprocedures.Manually enteredinfusionsandotherinformationpertainingtononencodeddruginjectionsmaybeincludedin thepatientmedicationrecord. TheTabletcomputerwirelesslycommunicateswiththeGatewayonthehospitalnetwork,anditmay sendmedicationadministrationtoHospitalInformationSystems,whenconfigured,forreportingand electronicrecordkeepingpurposes. 10 IndicationsforUse TheAnesthesiaSystemprovidesarecordkeepingsystemwithpatientsafetyfeatures. Electronicavailabilityofthepatientsallergiesallowsforproactiveadversedrugeventscreeningwhen thepatientisintheperioperativeenvironmentpriortoanyanesthesiadrugdelivery. TheAnesthesiaSystemautomaticallydocumentsmedicationsinthepreop,intraop,andPACUareas whenusinganencodedprefilledsyringe.Thecliniciancanenterdrugmedicationbymanuallyselecting thedrugfromalistwhenusingasyringethatisnotencoded.Adruglibrary,managedbypharmacy, containsdrugspecificinformationusedfordocumentingdrugsontheanesthesiarecord,performing adversedrugeventchecks,andsubmittingmedicationutilizationinformationforbillingpurposes. Availabilityofthepatientsspecificdrugallergiesprovidesforprescreeningofthemedicationsthatare connectedtotheIntelliportdeviceforinjectiontocheckforanypotentialadversedrugevents.Italso providesamethodologyfornarcoticstrackingthroughitscomprehensivemedicationtrackingand wastingfeature. TheAnesthesiaSystemistobeusedinthehospitalperioperativeenvironments(inpatientand outpatient)andspecialprocedurerooms.TheAnesthesiaSystemmayalsobeusedinnursingcareunits forthetreatmentofpreandpostsurgicalpatientcare.Surgical/procedurepatientsshouldweigh greaterthan35kgs,andhaveanintravenouslineestablished.Thesystemmayalsobeusedinnursing careunitsforthetreatmentofpreandpostsurgicalpatientcare. ThecliniciansthatareintendedtousetheCRISIAnesthesiaSystemincludephysicianswithaspecialtyin anesthesiology,CertifiedRegisteredNurseAnesthetistsandRegisteredNurses.Theseindividualsare licensedtodelivermedicationsthroughapatientsvenousaccesspoint.(IFU026) TheIntelliportSensormaybeusedupto72hours.Itisnotintendedtobereused. TheIntelliportBaseisintendedforusewiththeIntelliportSensor.Itmaybereusedunlessithasa exceededitsUsefulLife.Itshouldbedisinfectedandfullyrechargedbetweenpatientuses. IntendedUse TheAnesthesiaSystemisanautomatedrecordkeepingsystemforuseinperioperativeandprocedural settings.Thesystemiscomprisedofainjectionportthatmeasuresadministrationofmedicationsto patients,andadataprocessingmoduletoautomatetracking.Thesystemalsoincorporatespatient safetyfeatures(alertsforpatientallergies)thatarealignedwithhospitalpatientrecordsandprotocols, anditincludesamethodologyfornarcoticstrackingthroughacomprehensivemedicationtrackingand wastingfeature.TheAnesthesiaSystemhasbothdisposableandreusableparts,andtheoverallsystem isintendedforprescriptionuseonly. TheIntelliportdeviceisintendedtobeusedonaYsite,stopcockorIVmanifoldinjectionportofany peripheralintravenousestablishedline.Thisincludesacentralvenouslineorperipherallyinserted centralcatheter(PICC)line.Itisnotintendedtobeusedintheintraarterialorepidurallines.Venous linescanbeestablishedinthesubclavian,femoral,intraosseousorvariousperipheralarmlocations. TheIntelliportdevicemayrestorbesecuredtothepatientsskinineitheroftheselocations. 11 Section II Safety Precautions TheinformationcontainedintheseInstructionsforUseisintendedtoassistinthesafeoperationofthe AnesthesiaSystem.ThisproductistobeusedasspecifiedwithintheseInstructionsforUseandin accordancewithfederalguidelines. READALLINSTRUCTIONSBEFOREUSING. SAVETHESEINSTRUCTIONS. WarningsandPrecautions General DonotusetheAnesthesiaSystemnearMagneticResonanceImaging(MRI)equipment, includingstereotaxistechnology.(IFU017)RemovetheIntelliportdevicefromtheIVY sitepriortoimaging. DonotusetheAnesthesiaSystemneartherapeuticradiationequipment,suchaslinear accelerators.RemovetheIntelliportdevicefromtheIVYsitepriortoimaging. Shockhazard:donotattempttoconnectordisconnecttheTabletcomputeror IntelliportRechargerpowercordwithwethands.Makecertainthatyourhandsare cleananddrybeforepressingthepowercord. UseonlythepowercordsuppliedbythemanufacturerfortheTabletcomputeror IntelliportRecharger.Neveradapttheplugtofitanonstandardoutlet. Inspectthepowersupplycordfordamagepriortouse.ReplacetheTabletcomputer powersupplyonlywiththeCRISIapprovedpowersupply. Observerequirementsforpropergrounding.Thepowerreceptaclemustbeathree wiregroundedoutlet.Ahospitalgradeoutletisrequired.Neveradaptthethreeprong plugfromtheTabletcomputertofitatwoslotoutlet.Iftheoutlethasonlytwoslots, makesurethatitisreplacedwithathreeslotgroundedoutletbeforeattemptingto operatetheTabletcomputer.Provideanisolatedpowersupplyforoperation. Universalprecautionsshouldbeobservedtopreventcontactwithbloodorother potentiallyinfectiousmaterials.Placecontaminatedmaterialsinaregulatedwaste container. Donotmixdisinfectingsolutions(e.g.,bleachandammonia)neartheAnesthesia System,ashazardousgasesmayresult. Useaccessoryequipmentrecommendedbythemanufacturer.Theuseofnonapproved accessoryequipmentwiththeAnesthesiaSystemisnotrecommended,andmayleadto unsafeconditions. Donotmodifyortamperwithsystemcomponentsforanyreason.Doingsowillvoidthe manufacturerwarranty.Thesystemdoesnotincludeserviceablecomponents.Contact 12 yourAnesthesiaSystemrepresentativeforallrepairs. Donotusedamagedequipment,frayedordamagedpowercords.(IFU023) DonotexposetheAnesthesiaSystemtogasorheatsterilization.Autoclavingwill seriouslydamagetheIntelliportBaseandTabletcomputer. AvoidliquidingresstotheTabletcomputerorIntelliportBase.Fluidsmayinterferewith theirperformance. Operationofelectroconvulsivetherapy(ECT)equipmentduringuseoftheAnesthesia SystemmaytemporarilyresultinsignallossbetweentheIntelliportdeviceandTablet computer. NOTE IfanypartoftheAnesthesiaSystem(Tabletcomputer,Intelliportdevice,Recharger)is droppedorseverelydamaged,immediatelyremoveitfromuseandhaveitinspectedby servicepersonnel.Ensureitsproperfunctionpriortoreuse. Tabletcomputer Thegroundleakagecurrentislessthanspecifiedlimitsestablishedforcommercial Tabletcomputerpowersupplies.Asamatterofsafepractice,yourfacilityshould conductperiodicteststoverifythesecurrents.ItisrecommendedthattheTablet computerACpoweradapterbeconnectedtoanisolatedpowersupply. Electricalshockhazard:DonotremovetheTabletcomputercover.ThereareNO serviceablepartsinsidetheTabletcomputer. Iftheintegrityoftheexternalprotectiveearthgroundisindoubt,theTabletcomputer canbeoperatedfromitsinternalbatterypowersource. SustainedcontactoftheTabletcomputerwithskincancausediscomfortorburns.Do notallowtheTabletcomputertorestdirectlyonexposedskinforextendedperiods. ThesurfacetemperatureoftheTabletcomputermayriseduringnormaloperation particularlywhenoperatingunderACpower. BesuretheTabletcomputerismountedsecurelyinplacetoavoidfallingandsustaining injury. Tocompletelyremovepowerfromtheunit,disconnectthepowercordfromthepower receptacleoftheTabletcomputer. ProperlysecuretheTabletcomputerpriortouseorafterpositioning.Donotloosely placetheTabletcomputeronotherequipment.(IFU022) DonotblockventilationinletholesontheundersideoftheTabletcomputer. 13 DonotopenormodifytheTabletcomputerforanyreason.Thereisasealtoprevent liquidsfromentering,whichmaybedamagedifopened. TheTabletcomputercanonlybeusedwiththeAnesthesiaSystem. Beforeeachuse,checkthevolumeofaudiblealertstoensuretheyarenotmuted. Silencingthealertsmayadverselyaffectpatientsafety. DonotpushanyobjectsintotheairventsorotheropeningontheTabletcomputer. Doingsocancausefireorelectricshock. DonotusepressurizedsprayswhencleaningtheTabletcomputerscreen. DonotusehardorpointedobjectsontheTabletcomputerscreen. NOTE NOTE NOTE NOTE NOTE Intelliportdevice IntelliportdeviceshouldnotbeusedwithanArterialorepiduralline.Thismayresultin seriousinjurytothepatient.VerifythelineplacementpriortoIntelliportYsite attachment.(IFU011) DonotuseaneedleorbluntplastictipcannulawiththeIntelliportSensor.Thismay resultinportvalvedamageresultinginfluidleaks,airintakeandbacterial contamination.ReplacetheIntelliportSensorimmediately. PrimetheintravenouslineandIntelliportSensorwithflushsolutionpriortobeginning aninjection.TrappedairmayaffectIntelliportSensorperformanceandtheinjected volumemeasurement.FailuretoprimetheIntelliportSensorcorrectlymaycausethe volumeofinjectedmedicationtoreadlowerthantheactualtotaldeliveredtothe patient. CheckforanblockedfluidpathorleakingfittingswhenprimingtheIntelliportSensor. SecuretheIntelliportdevicetothepatientpriortopatienttransporttoavoid intravenouslinedisruption.(IFU021) NotetheclarityoftheIVtubingandIntelliportSensorduringusetominimizebacteria growth.ReplacetheIntelliportSensorifahighlipidmedicationhasbeeninjectedor bloodisvisibleinsidethelumenoftheIntelliportSensororport. DonotusetheIntelliportSensorwithanIVlineusingahighpressureinfusionflow system.VerifythelineplacementpriortoIntelliportYsiteattachment. 14 ThisdevicecomplieswithPart15oftheFCCRules.Operationissubjecttothefollowing twoconditions:(1)Thisdevicemaynotcauseharmfulinterference,and(2)Thisdevice mustacceptanyinterferencereceived,includinginterferencethatmaycauseundesired operation. ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforClassBDigital Device,pursuanttoPart15oftheFCCRules.Theselimitsaredesignedtoprovide reasonableprotectionagainstharmfulinterferenceinaresidentialinstallation.This equipmentgeneratesandcanradiateradiofrequencyenergyand,ifnotinstalledand usedinaccordancewiththeinstructions,maycauseharmfulinterferencetoradio communications.However,thereisnoguaranteethatinterferencewillnotoccurina particularinstallation.Ifthisequipmentdoescauseharmfulinterferencetoradioor televisionreception,whichcanbedeterminedbyturningtheequipmentoffandon,the userisencouragedtotrytocorrecttheinterferencebyoneormoreofthefollowing measures. Reorientorrelocatethereceivingantenna Increasetheseparationbetweentheequipmentandreceiver Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhich thereceiverisconnected Consultthedealeroranexperiencedradio/TVtechnicianforhelp Anychangesormodificationsnotexpresslyapprovedbythepartyresponsiblefor compliancecouldvoidtheusersauthoritytooperatetheequipment Leschangementsoumodificationsnonapprouvsexpressmentparlapartie responsabledelaconformitpourraitannulerl'autoritdel'utilisateurfaire fonctionnerl'quipement. ThisdevicecomplieswithIndustryCanadalicenceexemptRSSstandard(s).Operationis subjecttothefollowingtwoconditions:(1)thisdevicemaynotcauseinterference,and
(2)thisdevicemustacceptanyinterference,includinginterferencethatmaycause undesiredoperationofthedevice. LeprsentappareilestconformeauxCNRd'IndustrieCanadaapplicablesauxappareils radioexemptsdelicence.L'exploitationestautoriseauxdeuxconditionssuivantes:(1) l'appareilnedoitpasproduiredebrouillage,et(2)l'utilisateurdel'appareildoit acceptertoutbrouillageradiolectriquesubi,mmesilebrouillageestsusceptibled'en compromettrelefonctionnement.) 15 DonotusetheIntelliportSensorwithanIVlineusingahighpressureinfusionflow system.VerifythelineplacementpriortoIntelliportYsiteattachment. NOTE NOTE Verifytheencodinglabeliscleanandsecuretothesyringetippriortoattachingtothe IntelliportSensor. DisposeoftheIntelliportBaseitaccordingtoyourfacilitysprotocolforbatterydisposal oflithiumionbatteries. DiscardtheIntelliportSensorifitssterilepackagingisnotintactortheprotectorcapis detached. CliniciansmustbefamiliarwithandbetrainedintheuseoftheAnesthesiaSystem.Its useshouldbeprecededbyanestablishedfacilityprotocol. Swabtheinjectionportwith70%isopropylalcohol(ortheagentthatishospital standard)andallowtodrypriortoeachsyringeinjectiontominimizethepotentialfor crosscontamination. ChangetheIntelliportSensoraccordingtofacilitypolicyforIVsetchangeorCDC(USA) Guidelines;oriftheintegrityoftheIntelliportdevicehasbeencompromised.(IFU025) TheAnesthesiaSystemisneitherdesignednorintendedtodetectnoralertifthereare needleinfiltrations.Hospital/facilitypersonnelmustensuretheperformanceofthe commonIVsite,priortoconductingbolusinjections. VerifythattheIntelliportdeviceissecurelyluerlockedtotheYsiteandtheIVtubingis freefromkinksbeforeoperating. TheIntelliportSensordoesnothaveastopvalve(checkvalve);therefore,itis recommendedtoclosetheupstreamflowontheIVlineduringinjectiontolimit retrogradeflow. 16 Section III Description of Anesthesia System Components TheAnesthesiaSystemisdesignedwithyourneeds,safetyandworkflowinmind.Thissectionwill familiarizeyouwiththeAnesthesiaSystemcomponents,operationalmodes,displayviews,controls,and indicators. SuppliesandEquipment TheAnesthesiaSystemisdesignedforusewiththefollowingequipment. IVvenouslinewithYsiteneedlelessport(s),stopcockormanifold Intelliportdevice(sterilepackagedIntelliportSensorandchargedIntelliportBase) Medicationsyringes(havingencodingandwithoutencoding) Tabletcomputer Recharger Intelliport TheIntelliportdeviceisanintelligentinjectionport.Itattachestoaninjectionsite(YSiteorstopcock) formanuallyadministeredIVinjections.ItiscomprisedofasingleuseIntelliportSensorandareusable IntelliportBase,whichsnaptogetherpriortouse.UptothreeIntelliportdevicesmaybeinusewitha patientatonetime.ThesemaybeattachedtotwoorthreeseparateIVlinesforthepatientorattached viaamanifoldordifferentYsitesonthesameIVline.TheIntelliportdevicehasmemorythatwillstore atimebasedmedicationhistorylogfromthetimeofactivationtothetimewhenthedataissenttoa Tabletcomputer. IntelliportSensor TheIntelliportSensorisasteriledisposablehavinganinjectionportandaLuerlockconnection.The IntelliportSensorissuppliedinasterilepackageforsinglepatientuse.(IFU020)TheIntelliportSensor hasamaleLuerlockconnectiononaoneinchIVtubingpigtail.ThiscanbeattachedtoanIVlineataY siteorIVmanifold.AnIntelliportSensorcannotbereusedwithadifferentpatient.EachIntelliport Sensorhasauniqueserialnumber.Thelast4digitsoftheserialnumberareimprintedonthesurface nexttoitsbarcode.ThisnumberisusedtoidentifyanIntelliportSensorwithinwirelessrangeusingthe Tabletcomputer. Last4digitsof SerialNumber Figure3IntelliportSensorwithlast4digitsoftheSerialNumber 17 Figure4IntelliportDeviceComponents TheIntelliportSensorincludesaninjectionportandanIVconnectiontotheIVline.Theinjectionportis acommonneedleless,Luerlocktype.Itmaybecleanedpriortogivinganinjectionaccordingto hospitalpolicy.PrimingwithanIVfluid(e.g.normalsalinesyringe,orpullbackfromIVline)isrequired beforeuse.TheinjectionportontheIntelliportSensorsupportsupto100injections. TheIntelliportSensorispackagedsterile,donotuseifpackageisdamagedorprotector capisnotattached. Donotuseaneedleorblunttipplasticcannula.Replaceimmediatelyifeitheris inadvertentlyusedresultingindamagetotheIntelliportSensor(typicallyleaks). PrimeIntelliportSensorbeforeuse.Attachaflushsyringetotheinjectionportand purgeinfusionfluidtoremoveairfromtheIntelliportSensor. ConfirmtheLuerlockissecurelyconnectedtoafullyprimedprimaryinfusionsetbefore use. DiscontinueuseoftheIntelliportSensorifthesyringeissecurelyattachedandyou observeleaking(dropletsformingattheinjectionport)duringaninjection. NOTE UseAsepticTechniquewhenhandlingtheIntelliportSensor. IntelliportBase TheIntelliportBaseisanonsterile,reusabledevicethathousesthebattery,electronicsandwireless transmitter(calledaRadio).Itisbatterypowered,andrechargeable.Donotdiscardafteruse.An IntelliportBaseisdesignedtobereusable.Itsupportsupto500reuseswithdifferentpatients.Each IntelliportBasehasauniqueserialnumberimprintedonitssurface.Thisnumberistransmittedtothe Tabletcomputerduringuse.ThedistancebetweentheIntelliportdeviceandaTabletcomputershould be10metersorlessinorderfortheIntelliportdevicetosendandreceivewirelesscommunications. Therechargeablelithiumbatteryisnotremovable.TheentireIntelliportBaseconnectstothe Recharger.AfullychargedIntelliportBaseissuitableforupto24hoursofuse,undertypicalconditions. 18 WhentheIntelliportBaseisconnectedtoaRecharger,upto4greenlightbarswillilluminate.The numberofsolidgreenlightbarsindicatesthelevelofcharge.Theblinkinglightwillindicateitis recharging. upto25%charged upto50%charged upto75%charged fullycharged verylowbattery5%
WhentheIntelliportBaseisconnectedtoaRechargeraredlightindicatestheIntelliportBase hasexceededitsUsefulLife.RefertoSectionXXCare&Maintenanceformoreinformation. Status TheIntelliportBaseisequippedwithstatusindicatorstoconveythefollowinginformation:
Operating Error Identify ClinicalAlert Adoubleblinking,greenlightindicatestheIntelliportdeviceispoweredonand notyetwirelesslyconnectedtoaTabletcomputer. Aredlightindicatesanerrorispresent.RefertoSectionXXTroubleshootingfor moreinformation. Green/yellowlightsflashfor3secondswhenanIntelliportdevicehasbeen selectedattheTabletcomputer. Red/green/yellowlightsflashfor3secondswhenapriorityclinicalalerthasbeen triggered.ThisinformstheclinicianofanalertmessageontheTabletcomputer.
(e.g.aknownallergytoadruginaconnectedsyringe).(IFU010) EndofUse AredlightinthelowestbatterychargepositionindicatestheIntelliportBasehas beenusedwithmorethan500IntelliportSensors. Recharger AseparateRechargerrechargesthebatteryinthereusableIntelliportBasepriortoeachuse.Tousethe Recharger,snapontotheIntelliportBase. EncodedSyringes TheAnesthesiaSystemsupportsinjectionsusinganyLuerlocktypesyringe.Inaddition,thesystemhas beendesignedtoworkwithencodedsyringesthathaveaspecialbarcodeidentifieronthesyringetip, calledencoding.Theencodingstoresinformationaboutthemedicationcontainedwithinthesyringe. 19 WhenanEncodedsyringesisattachedtotheinjectionport,thisinformationiswirelesslytransmittedby theIntelliportdevicetotheTabletcomputer. Encoded Syringe Figure5EncodedSyringeAttachment Tabletcomputer TheTabletcomputerisastandard,commercialTabletcomputerhavingAnesthesiaSystemsoftware,a pressscreen,wirelesscommunications(Radio).Itistypicallymountednearthecliniciansworkenvelop. Itmayalsoberemovableforhandhelduse.TheOnOffswitchislocatedatthetop,rightofthe Tabletcomputer.ItincludesanACpoweradapter.Italsosupportsupto4hoursofbatterypowered use,undertypicaloperatingconditions. On/OffSwitch ACpoweradapter Figure6TabletcomputerFeatureLayout ReviewTabletcomputerWarningslistedonpagesXXpriortouse. TheTabletcomputersupportsonepatientatatime.SolongasacaseisongoingattheTabletcomputer, noothercasesorpatientscanbeaccessed.Inaddition,onlyoneclinicianmaybeloggedintoaTablet computeratatime. SoftwareRunninginStandaloneMode Whenusedinahospitalhavingapaperanesthesiarecord,theTabletcomputersupportsfeaturesthat assistwithdocumentingtheflowsheetportionandmayhelpwithdecisionsbytheclinician.Inthis configuration,theTabletcomputercomplementsthepaperrecordkeepingactivitiesbytrackingand 20 displayinginjectionsgiventhroughtheIntelliportdevice.Italsoenablesclinicianstomanuallydocument otherpertinentIVdruginjectionandinfusioninformation. Thesoftwarescreensfollowathreestepapproachconsistingof1)connectingtheIntelliportdevice,2) settingupthepatient,and3)viewingmedicationadministrationineithertheAnesthesiaViewor NursingView.RefertoSectionsXXforinformationonconnectingtheTabletcomputertoanIntelliport deviceandsettingupapatient. Figure 7 Stand Alone Mode ThefollowingsectiondescribesthebasicscreensontheTabletcomputer:
AnesthesiaView TheAnesthesiaViewisaprimaryscreenforclinicianstointerfacewiththeAnesthesiaSystem.Thisview providesinformationaboutthepatient,displaysdrugname/concentrationanddoseforacurrent injectionaswellasahistoricallistofmedicationsthathavebeendeliveredtothepatient.Ifmayalso includealistingofinfusionsgiventothepatient,ifrecordedbytheclinician. 21 Figure 8 Anesthesia View InjectionBarsUptothreeinjectionbarsdisplayacrossthetopofthescreen,onecorrespondingto eachwirelesslyconnectedIntelliport.Eachinjectionbarisarealtimerepresentationofthemedication beingadministeredthroughanIntelliportdevice.WhenanencodedsyringeisattachedtoanIntelliport device,theinjectionbardisplaysthedrugnameandconcentration.Whenanunencodedsyringeis attached,theInjectionBarwillreadSelectMedpromptingthecliniciantoidentifythemedicationand concentration.Asthemedicationisbeingdelivered,thevolumepushed(inmL)andthecorresponding dosedisplaysinrealtimeintheinjectionbar. MedicationHistoryTheAnesthesiaViewincludesahistoricallistofmediationsthathavebeen deliveredtothepatientorganizedbycarearea(medicationsgiveninthetransitiontimebetweencare areas,willposttothenextcarearea)arrangedinaflowsheetformat.Thisincludesallmedicationsthat wereadministeredtothepatientsincetheIntelliportdevicehasbeenactivatedwiththemorerecent medicationadministrationsatthebottomofthelist.Ascrollbarisenabledwhenthelistexceedsthe visiblespaceonthescreen.Whenanewmedicationisadded,themedicationlistwillscroll automaticallysothenewmedicationnameisvisible.Handgesturingintheflowsheetwillscrollthe flowsheettoviewhiddenmedicationadministrations. NOTE Foranesthesiamedications,acolortilecorrespondingtotheAmericanSocietyof Anesthesiology(ASA)guidelinesdisplaysadjacenttothedrugname.(RefertoAppendix Xformoreinformation). Theflowsheettimescaleisadjustableanditcanshow1minute,5minute,and10minuteincrements. 22
"Dose"isshownonaflagbasedonthetimeinwhichitwasdelivered.Pressingtheflagforaspecific medicationwilldisplaytheModifySelectedMedicationpopup.Fromthispopup,themedication administrationcanbeviewedandmodified.Acliniciancanmodifytheconcentration,dose.Thisscreen isalsousedtospecifyacocktail(mixedmedication),adilutedorreconstitutedmedication. PressingtheUnitTotalnumberforamedicationwilldisplayapopupscreenindicatingthemedication andconcentration,totaldosegiven,numberofdosesgivenbycarearea,andtimeofeachdose.To close,pressOKonthebottomofthepopupscreen. Figure 9 Unit Total TheInfusionsectionislocatedabovethetimescale.Itdisplaysallcontinuousinfusionsrecordedbythe clinician.Thosethatarecurrentlyactiveareshownwithabluebarandthosethatareinactivehavea blackbar.ThisfeaturecanbehiddentoshowadditionalinjectionsbypressingHideInfusionsfrom theMenu. TheCaseHeaderinformationliststhepatientname,dateofbirth,ageinyears,medicalrecordnumber andpatientidentificationnumber. TheMessageSectiondisplaysclinicalandsystemmessagesprioritizedbyimportanceandtime.The Messageiconwillshowthenumberofunaddressedmessagesfortheclinician.Clinicalmessagesthat havehigherimportance,suchasallergyalerts,willappearinthecenterofthedisplayscreen.(Figure XX) TheTitleBardisplaysacrossthetopofthescreen.Itincludesthenameoftheclinicianloggedin(ifso configured)andthelocationassignedtotheTabletcomputer.ThefirsticontotherightoftheBar indicatesifwirelesscommunicationbetweentheGatewayandtheTabletcomputerareactive.A secondicon specifieswhethertheTabletcomputerspeakersaremutedorunmuted.Thebattery iconindicatestheremainingamountofchargeontheTabletcomputerandlastly,thehospitalnetwork timeisshown. NursingView TheNursingViewisasecondscreenforclinicianstointeractwiththeAnesthesiaSystem.Likethe AnesthesiaView,thisviewprovidesinformationaboutthepatient,displaysdrugname/concentration 23 anddoseforacurrentinjectionaswellasahistoricallistofmedicationsthathavebeendeliveredtothe patient.Itmayalsoincludealistingofinfusionsgiventothepatient,ifrecordedbytheclinician. Figure 10 Nursing View TheNursingViewhasmanyofthefeaturesintheAnesthesiaView;howeveritisarrangedinatabular format.Thetableheadingsinthisviewincludemedicationwithconcentration,timeadministered,dose, andunittotal.Themedicationsaredisplayedinreversechronologicalorderwithmostrecent medicationadministeredatthetopofthelist.Ascrollbarisenabledwhenthelistexceedsthevisible spaceonthescreen.Handgesturinginthetablewillscrolltoviewhiddenmedicationadministrations. Theblackhorizontalbarsidentifythecareareainwhichthemedicationsweregiventothepatient,or whentransitioningfromonecareareatoanother. ButtonandMenuOptions Thefollowingfeaturesareavailablefromthefourbuttonslocatedinthelowerrightcornerofthescreen
(Allergies,Comments,Add,Menu):
Add Infusion Add Injection Add Comment Selectthisoptiontorecorddetailsaboutaninfusion. RefertoSectionXformoreinformation. Selectthisoptiontorecorddetailsaboutaninjection givenpriortoactivatinganIntelliportdeviceorgiven throughaportotherthantheIntelliportdevice.Referto SectionXformoreinformation. Selectthisoptiontorecordgeneralcomments.(thereare additionalwaystopairacommentwithanallergyordrug 24 Allergies PauseCase CloseCase SwitchUser Show/HideInfusions ChangeTimeScale Sound/Mute Preferences Reports HandoffView NursingView injection).RefertoSectionXformoreinformation. Selectthisoptiontoviewthelistofallergies,including severityandtypeofreaction. Pressthisbuttonwhentransferringapatienttoanother carearea.Indoingso,itdisconnectsallconnected Intelliportdevicesinpreparationfortransfer.Referto SectionXformoreinformation. Pressthisbuttonwhenthecaseiscompleteandthe patientisbeingpreparedfortransferoutofthe perioperativearea.Indoingso,itpowersdownall connectedIntelliportdevices.RefertoSectionXformore information. NOTE:Pressingthisbuttonwillclosethecaserecordon theAnesthesiaSystem.Thecasewillnolongerbe availabletothenextcarearea. Selectthisoptiontochangetheclinicianloggedin,ifso configured.RefertoSectionXformoreinformation. Pressthisbuttontotogglebetweendisplayingorhiding infusionsontheAnesthesiaViewflowsheet.Referto SectionXformoreinformation. Pressthisbuttontotogglebetween1minute,5minute and10minutetimeintervalsontheAnesthesiaView flowsheet. Pressthisbuttontotogglebetweenaudible announcementsandmute.RefertoSectionXformore information. Selectthisoptiontoviewandmodifypreferencesfor announcements,volumeandscreenbrightness.Referto SectionXformoreinformation. SelectthisoptiontoviewandprinttheControlled Substance,Handoff,andMedicationAdministration reports.RefertoSectionXformoreinformation. PressthisbuttontoviewtheHandoffscreen.Referto SectionXformoreinformation. PressthisbuttontoviewtheNursingViewscreen.Refer toSectionXformoreinformation. 25 AnesthesiaView PressthisbuttontoviewtheAnesthesiaViewscreen. RefertoSectionXformoreinformation. Help ShutDown Selectthisoptionwhenseekingassistanceinoperation.It provideshelpfulinformation,includingtheDirectionsfor Use.(IFU028) PressthisbuttontopowerofftheTabletcomputer.Refer toSectionXformoreinformation. 26 SoftwareRunninginEMRIntegratedMode Whenusedinahospitalhavingelectronicmedicalrecords(EMR)intheperioperativecareareas,the TabletcomputerservesasacompaniontotheEMRsystemorperioperativeinformationmanagement system(calledaPIMS).Inthisconfiguration,theTabletcomputerprovidesarealtimedisplaywhilethe drugisbeinginjected,thenitsendstheinjectionsdatainrealtimetotheEMR.Theclinicianrefersto theEMRforahistoryofmedicationsgivenunlikethepaperanesthesiarecordconfiguration. Thesoftwarescreensfollowathreestepapproachconsistingof1)connectingtheIntelliportdevice,2) verifyingthepatientinformationreceivedfromtheEMR,and3)givinginjections.RefertoSectionsXX forinformationonconnectingtheTabletcomputertoanIntelliportdeviceandsettingupapatient. Figure 11 EMR Integrated Mode TheCompanionViewhasaprimaryscreenforclinicianstointerfacewiththeAnesthesiaSystem.This Viewprovidesinformationaboutthepatient,displaysdrugname/concentrationanddoseforthe currentinjectionandrelevantclinicalandsystemmessages. 27 Figure 12 EMR Integrated (Companion View) TheCompanionViewconsistsofthefollowingscreenfeatures:1)ActiveInjectionBar;2)TitleBarwith cliniciannameandlocationofdisplayTabletcomputer;3)CaseHeaderinformationonpatientname, MRN,Patientidentificationnumber;4)Allergies;5)ClinicalorSystemMessages. InjectionBarsUptothreeinjectionbarsdisplayonthescreen,onecorrespondingtoeachwirelessly connectedIntelliportdevice.Eachinjectionbarisarealtimerepresentationofthemedicationbeing administeredthroughanIntelliportdevice.WhenanencodedsyringeisattachedtoanIntelliport device,theinjectionbardisplaysthedrugnameandconcentration.Whenanunencodedsyringeis attached,theInjectionBarwillreadSelectMedpromptingthecliniciantoidentifythemedicationand concentration.Asthemedicationisbeingdelivered,thevolumepushed(inmL)andthecorresponding dosedisplaysinrealtimeintheinjectionbar.Uponcompletionofthesyringepush,themedication administrationwillpassimmediatelytotheEMRwithaconfirmationmessageconfirmingsuchinthe messagearea. NOTE Foranesthesiamedications,acolortilecorrespondingtotheAmericanSocietyof Anesthesiology(ASA)guidelinesdisplaysadjacenttothedrugname.(RefertoAppendix Xformoreinformation). TheCaseHeaderinformationliststhepatientname,dateofbirth,ageinyears,medicalrecordnumber andpatientidentificationnumber. TheMessageSectiondisplaysclinicalandsystemmessagesprioritizedbyimportanceandtime.The Messageiconwillshowthenumberofunaddressedmessagesfortheclinician.Clinicalmessagesthat havehigherimportance,suchasallergyalerts,willappearinthecenterofthedisplayscreen.(Figure XX) TheTitleBardisplaysacrossthetopofthescreen.Itincludesthenameoftheclinicianloggedin(ifso configured)andthelocationassignedtotheTabletcomputer.ThefirsticontotherightoftheBar indicatesifwirelesscommunicationbetweentheGatewayandtheTabletcomputerareactive.A 28 secondicon specifieswhethertheTabletcomputerspeakersaremutedorunmuted.Thebattery iconindicatestheremainingamountofchargeontheTabletcomputerandlastly,thehospitalnetwork timeisshown. 29 Section IV Operations TheAnesthesiaSystemisdesignedwithyourneeds,safetyandworkflowinmind.Thischapterwill acquaintyouwiththeAnesthesiaSystemoperationalmodes,displayviews,controls,andindicators.It alsoprovidesgeneralinformationonuseofthedevice. QuickGuide PreparetheIntelliport TheIntelliportdevicemustbeprimed,attachedtoanIVlineandassembledinpreparationforuse. 1. GatheranIntelliportSensorinitssterilepackagingandafullychargedanddisinfectedIntelliport Base. 2. PrimebyflushingwithsterileIVfluidbeforeattachingtotheYsiteORbyaspiratingIVsolution throughasyringeattachedtotheport. 3. AttachtheIntelliportSensortotheIntelliportBasebyjoiningtheIntelliportSensor(tubingside) andIntelliportBasefrontsectionsfirst,thensnapthetwotogether.Oneshouldaudiblyhear thesnap. 4. VerifyproperseatingofIntelliportSensortotheIntelliportBasebycheckingforablinkinggreen lightontheIntelliportdevice.Ifthisisnotseen,viewtheIntelliportdeviceonitssideto determineifthetwoareproperlyconnected.IfaspaceisseenbetweentheIntelliportSensor andIntelliportBase,thenseparateandreattachproperly. 5. TheIntelliportdeviceisnowreadyfordeliveryofIVmedications.Anymedicationsgiventhrough theIntelliportdevicewillbesavedtotheIntelliportmemory. SetuptheTabletcomputer TheTabletcomputermustbesetuptowirelesslycommunicatewiththeIntelliportdeviceandtobe associatedwithapatientrecord.AnyMedicationsgivenpriortoassociationtoaTabletcomputerwill beheldintheIntelliportmemory.ThreeIntelliportdevicescanbesynchronizedtoonepatient. 6. PowerontheTabletcomputerbypressingandholdingthebuttonlocatedontopofTablet computer. 7. Thefirstscreensupportslogin,ifsoconfigured.EnterUsernameandPassword 8. 9. FromtheIntelliportSetupscreen,select(highlight)theIntelliportdevicecorrespondingtothe Identifythe4digitnumberontheIntelliportSensor. fourdigitsnumberontheIntelliportSensor. 10. VerifythecorrectIntelliportdevicehasbeenselectedbycheckingthatthegreenandyellow lightsareblinking. 11. IftheidentifiedIntelliportdeviceiscorrect,pressConnect. 12. VerifytheIntelliportdeviceflashesasingle,repeatinggreenlightwhenitiswirelesslyconnected totheTabletcomputer. 13. Identifythepatientsfullname,patientID,medicalrecordnumberandbirthdate. 14. FromthePatientSetupscreen,selectthepatientfromthelist.PressEmergencytobegina 30 casewherepatientdemographicsarenotavailable. NOTE AfterstartingacaseusingtheEmergencybutton,thepatientcanbeidentifiedatany timepriortoclosingthecase. 15. ConfirmthecorrectIntelliportdeviceandpatienttocompletethesetup.Onceconfirmed, theAnesthesiaSystemhasestablishedapermanentassociationbetweenthepatientand IntelliportSensor. GiveIVinjectionsandViewMedicationAdministrations 16. CleantheIntelliportSensorinjectionportbyswabbingthehubaccordingtoyourhospital protocol. 17. AttachasyringetotheIntelliportSensorinjectionport. 18. VerifythedrugdisplayedandannouncedbytheTabletcomputeristheintendeddrugand concentration.Whenusingasyringewithoutencoding,SelectMedwillannounceanddisplay alistofmedicationstoidentify.(PressMoreifyoudonotseethemedicationname). a. Identifythemedicationbeforeorafterdosedelivery.Confirmmedicationandpress Save. b. Frequentlydilutedorreconstituteddrugsshalldisplaynodosevalueuntiltheclinician identifiesthegivendoseontheModifySelectedMedicationscreen.Theidentified dosewillappearontheflag. c. Cocktail(mixingtwomedicationsinonesyringe)canbeidentifiedbypressingthe CocktailbuttonfromtheSelectMedscreen. UseclinicaljudgmentbeforeproceedingwhentheTabletcomputerannouncesand displaysaknownallergyforthedrugattachedtotheIntelliportdevice,ifsoconfigured. 19. ThevolumeanddosewilldisplayontheTabletcomputerwhenthesyringeisremovedoratend oftheinjection,ifthesyringeisleftattachedtotheIntelliportdevice. 31 DetailedOperatingInstructions PreparetheIntelliport TheIntelliportdevicemustbeprimed,attachedtoanIVlineandassembledinpreparationforuse. 1. GatheranIntelliportSensorinitssterilepackagingandafullychargedanddisinfectedIntelliport Base. NOTE AfullychargedIntelliportBasehassufficientpowerfor24hoursofuseundertypical conditions.InspecttheIntelliportBasechargelevel.ReplaceanIntelliportBasewith lessthan25%charge.Thiscanbedoneatanytimesolongasaninjectionisnotbeing given. VerifytheIntelliportBasehasbeencleanedanddisinfectedbeforeuse. VerifytheIntelliportSensorsterilepackageisintactandthetubingendcapisstillin place. 2. PrimebyflushingwithsterileIVfluidbeforeattachingtotheYsiteOR,byaspiratingsolution fromtheIVlinethroughasyringeattachedtotheport.(IFU01) NOTE Afterpriming,visuallyinspectforleaksorblockagetotheIVline. 3. AttachtheIntelliportSensortotheIntelliportBasebyjoiningtheIntelliportSensor(tubingside) andIntelliportBasefrontsectionsfirst,thensnapthetwotogether.Oneshouldaudiblyhear thesnap.ConnectingIntelliportSensortoIntelliportBasewillautomaticallypoweronthe Intelliportdevice. NOTE TheconnectionofIntelliportSensortotheIntelliportBaseisverifiedbyablinkinggreen lightontheIntelliportdevice.Ifthisisnotseen,viewtheIntelliportdeviceonitssideto determineifthetwoareproperlyconnected.IfaspaceisseenbetweentheIntelliport SensorandIntelliportBase,thentheyarenotattachedproperly.Separatethetwo piecesandreattach. 4. Whereappropriate,securetheIntelliportdevicetoasurfaceinpreparationforgivinginjections. AvoidkinksinthelinebetweentheIntelliportdeviceandIVline. SecureanIntelliportdevicepriortopatienttransport. 5. TheIntelliportdeviceisnowreadyfordeliveryofIVmedications.Anymedicationsgiventhrough theIntelliportdevicewillberecordedintheIntelliportmemory. IntheeventofaSystemorIntelliportfailure,(excludingthefluidpathway),theIntelliportdevicewill allowstandardmedicationorfluiddelivery. SetuptheTabletcomputerPaperAnesthesiaRecord TheTabletcomputermustbesetuptowirelesslycommunicatewiththeIntelliportdeviceandtobe associatedwithapatient. 32 6. TurnontheTabletcomputerbypressingandholdingthepowerswitchontopofTablet computer. NOTE NOTE TheTabletcomputercanoperatefor4hoursonbatterypower(notpluggedintoa powersupply)undertypicalconditions.VerifytheTabletcomputerispluggedinpriorto usebycheckingthepowerindicatorontheTitlebarontheTabletcomputerscreen. Onstartup,theinitialscreenwilldisplayinformationaboutthesoftware,druglibrary andconfigurationversionsaswellasinformationonnetworkconnectivity.Contact yourSystemAdministrationifsoinstructed. 7. TheLoginscreenwilldisplayiftheAnesthesiaSystemisconfiguredforuserlogin.TypetheUser NameandPassword,thenpresstheLoginbutton. Figure 13 Login NOTE TheTabletcomputerwilllocktheuseroutafterseveralunsuccessfulloginattempts. FollowthescreendirectionsforcontactingtheSystemAdministrator.(IFU029) 8. Identifythe4digitnumberontheIntelliportSensor. Lastfourdigitsof serialnumber Figure14Login 9. AlistofIntelliportdeviceswithinwirelessrangeareviewableontheIntelliportSetupscreen. Select(highlight)yourIntelliportdevicebytimeofinitialactivationandlastfourdigitsofthe serialnumberontheIntelliportSensor. 33 Figure 15 Connecting an Intelliport NOTE AlowbatteryiconwilldisplayforalistedIntelliportwhenlessthan25%ofbattery chargeremains(approximately4hoursundertypicalconditions).Considerreplacing withafullychargedIntelliportBasebeforeconnecting. 10. SelecttheIntelliportdeviceforyourpatientbypressingandhighlightingtheappropriate Intelliportserialnumber. 11. VerifythatthegreenandyellowlightsareflashingforthecorrectIntelliportdevice. NOTE Shouldyoumissthevisualconfirmation,highlighttheappropriateIntelliportdevice againtoinitiatetheblinkinglights. 12. Thescreenwillhighlightyourconnection. 13. TheIntelliportdevicewillilluminateasingle,repeatinggreenlightwhenitiswirelessly connectedtotheTabletcomputer. 14. Identifythepatientsfullname,patientID,medicalrecordnumberandbirthdatefromthe patientandwristband. 15. FromthePatientSetupscreen,selectthepatientfromthelist. 34 Figure 16 Patient Setup Ifthepatientisnotlisted,presstheMorePatientsbuttontofindthepatientontheADTlistby filteringthislongerlistbythepatientname,patientIDorMRN.Akeyboardwillappeartotype thefirstlettersoftheLastName. Figure 17 ADT Patient List NOTE ThereisanEmergencybuttonontheTabletcomputerscreenforpatientswhose nameisnotknownorthecliniciandeterminesanemergentsituationtostart medicationtreatment. 16. PresstheConfirmbuttontocompletethesetup.(IFU027)Shouldanypartoftheassociation beincorrect,thereisanopportunitytopresstheRemovebuttonandrepeatthepatient identificationstepprocess.(Figure18)Onceconfirmed,theAnesthesiaSystemhasestablisheda permanentassociationbetweenthepatientandIntelliportSensor.TheIntelliportSensorcan onlybepairedwithonepatient. 35 Figure 18 Confirm Patient Association NOTE IfthewrongpatientwasinadvertentlyconfirmedtotheIntelliportdevice,thereisa RemoveIntelliportbuttonontheMainMenubuttonthatwilldisassociatethepatient fromtheIntelliportdeviceandundoanymedicationadministrationhistory. ShouldtheIntelliportBasebecomedisconnectedfromtheIntelliportSensorduring operation,reattachandverifypatientassociation. 17. FollowingPatientSetup,theTabletcomputerdisplaysallergiesfortheselectedpatient,ifso configured.Knownallergies,withseverityandtypeofreactionwilldisplay(FigureXX). Figure 19 Patient Allergies 36 NOTE IfthepatientallergiesarenotavailablefortheTabletcomputer,theclinicianwillseea messageUnabletoObtain. NOTE TheTabletcomputerchecksforupdatestopatientallergyinformationduringacase. 18. ThereisanopportunitytotypeacommentforanallergybyselectingtheAllergyandpressing theCommentbutton.Akeyboardwilldisplaytotypeacomment.(Figurexx) 19. Oncethecommentisrecorded,presstheOKbuttontosave.ThiswillreturntotheAllergylist. GiveanIVinjectionUsingtheIntelliportDevice 20. Cleantheinjectionportbyswabbingthehubaccordingtoyourhospitalprocedure.(IFU013) 21. AttachasyringetotheIntelliportinjectionport. Doublecheckeachmedicationnameandconcentrationonthesyringepriorto attachmenttotheinjectionporttoassurerightmedication.(IFU02) 1. VerifythedrugdisplayedandannouncedbytheTabletcomputeristheintendeddrugand concentration.(IFU019)Forsyringesnothavingencoding,refertoSection:SpecialActivities;
MedicationDeliverywhenSyringesNotEncoded,thenreturntothisstep.(IFU04) 2. TheIntelliportdevicewillflashred,greenandyellowlightsifamedicationallergyisdetected,if soconfigured. UseclinicaljudgmentbeforeproceedingwhentheTabletcomputerannouncesand displaysaknownallergyforthedrugattachedtotheIntelliportdevice.Allergy messageswilldisplayasbelow:
3. ThereisnocheckvalveintheIntelliportSensor,socloseorpinchtheupstreamIVtubingoruse acheckvalveIVsettopreventmedicationtravelingtowardstheIVbagduringinjection.(IFU 009) NOTE Alternativestopreventretrogradeflowinclude:1)attachingathreewaystopcockonto theYsiteandluerlockingtheIntelliportSensorontothestopcock;2)attachinga manifoldtotheIVorextensiontubingandluerlocktheSensordirectlytothemanifold. 4. Whendeliveringmedications,observethegraduationsonthesyringetochecktheamountof drugdelivered.(IFU003)VerifydoseshownintheactiveinjectionbaroftheTabletcomputer.
(IFU007)TheIntelliportdevicemeasures0.4mLto55mLperinjection.(IFU008) 37 NOTE Iftheinjectionflowrateisveryslow,amessagewilldisplayontheTabletcomputer.
(IFU031)Iftheamountofinjectedmedicationisnotmeasurable,theactiveinjection barwillindicatedashesforvolumeanddose.Amessagewillinstructtheclinicianto enterthedosemanuallythroughtheModifySelectedMedicationscreen.Once completed,thedosewilldisplay.RefertoSectionXXXformoreinformation. NOTE Pushingmedicationfroma50mLsyringerapidlyhasthepotentialtocausecollapseof theIVline.Pushslowertoaccommodatedeliveryofalargeamountofmedication. 5. FollowallinjectionsthroughtheIntelliportdevicewithanencodedNormalSalineflushto ensurethefulldoseofmedicationsreachesthepatient,especiallywhensuccessivelydelivering twoincompatiblemedications.(IFU06) NOTE NormalSalinewillappearontheactiveinjectionbarwiththeamountofmLdelivered. Normalsalinemaynotdisplayonthemedicationhistory,ifsoconfigured. 6. MakeadjustmentstothemedicationadministrationrecordontheTabletcomputerfor injectionsinvolvingadiluteddrug,reconstituteddrug,ormixeddrugs,ifsoconfigured. InjectionsarerecordedwhetherornottheIntelliportdeviceiswirelesslyconnectedtotheTablet computer.TheIntelliportBasestoresinjectioninformationinitsmemoryandtransmitsthisinformation uponwirelessconnectiontotheTabletcomputer.(IFU030) 38 SpecialActivities SettingUserPreferences TheAnesthesiaSystemsupportsuserpreferencestodeterminethesoundvolume,screenbrightness andaudibleannouncements,remindersandmessages.(IFU016)Thehospitalhasconfigureddefault preferencesthatmaybemodifiedtemporarilyduringacase.ToverifytheTabletcomputerpreferences priortostartingacase,performthefollowing:
SelectPreferencesfromtheMenu. 1. 2. Adjustpreferencefortheworkenvironment. 3. PressSavebuttonwhencompleted. Checkwhetheralertshavebeenmutedwhenrelievingaclinicianduringacase. Preferencechangesareretainedduringthecase.Whenthecasehasclosedorwhenanewclinicaluser logsin,thesettingsreverttothedefaultconfiguration. Figure 20 User Preferences SelectingtheMuteoptionfromtheMenuwilloverridealloftheaboveselectionsand mutealldrugannouncements,clinicalremindersandsystemmessages.Tohearthe medicationannouncements,selectUnmute. AddingAdditionalIntelliports TheAnesthesiaSystemcanaccommodateupto3Intelliportdevicesconnectedtoonepatientatatime. AnadditionalIntelliportdevicecanbeaddedatanytimeduringacase.ThefirstconnectedIntelliport devicewilldisplayintheleftmostinjectionbar.Thesecondinthemiddle,andthethirdtherightmost injectionbar.RefertoFigure6. NOTE WhenanIntelliportisconnectedtoaTabletcomputerandthereisnosyringeattached totheIntelliportdevice,theactiveinjectionbarshallreadIntelliportConnected,No syringeattached.Abatterystatusiconwillindicatebatterychargelevelinthecorner oftheinjectionbar. 39 ToaddanIntelliportdevice:
1. PrepareanIntelliportdeviceaccordingtotheinstructionsinSectionX. 2. PressTaptoConnectonanyoftheremainingActiveInjectionBarspacestodisplayapopup windowthatlistsavailableIntelliportdeviceswithinwirelessrange. Identifythe4digitnumberontheIntelliportSensor. 3. 4. Select(highlight)yourIntelliportdevicebasedonthetimeofinitialactivationandthefourdigit numberontheIntelliportSensor. Figure 21 Connecting Additional Intelliports NOTE AlowbatteryiconwilldisplaywhentheselectedIntelliportdevicehaslessthan10%of batterypowerremaining. 5. TheselectedIntelliportdevicewillflashlightsfor3seconds. 6. VerifythegreenandyellowlightsareflashingforthecorrectIntelliportdevice. NOTE Shouldyoumissthevisualconfirmation,highlighttheappropriateIntelliportdevice againtoinitiatetheflashinglights. IftheidentifiedIntelliportdeviceiscorrect,pressConnect. 7. 8. VerifytheIntelliportdeviceisflashingasingle,repeatinggreenblinkinglightindicatingitis wirelesslyconnectedtotheTabletcomputer. 9. PressConfirm.AnActiveInjectionBarwilldisplaytheconnectedIntelliportdevice. MedicationDeliverywithSyringesNotEncoded TheAnesthesiaSystemisdesignedtoworkwithbothencodedsyringes(thosehavingaspecialbarcode identifieronthesyringetip)andunencodedsyringes.Whenanunencodedsyringeisattachedtothe Intelliportdevice,theTabletcomputerwilldisplaytheSelectMedicationpopuphavinga perioperativemedicationlist.(IFU018)Acliniciancanidentifythemedicationinthesyringebefore 40 givingtheinjection(recommended)orafterwards.Ifpostponed,theTabletcomputertracksinjections notyetidentifiedandlaterpromptsthecliniciantoresolve. 1. SelectthemedicationandconcentrationfromtheFrequentUselistbyhighlightingthename. Thislistincludesmedicationspreviouslyidentifiedduringthecaseasgivenbyanunencoded syringe. Figure 22 Select Medication 2. IfthedesiredmedicationisnotfoundontheFrequentUselist,pressMoretoviewalonger listofperioperativemedications. 3. Filterthelistbypressingthefirstlettersofthedrugnameusingthekeypad. 4. Highlightthedesiredmedicationandconcentration,verifytheinformationandpress Save.(IFU05) SpecifyingaDilutedorReconstitutedMedication TheTabletcomputerprovidesasimpleapproachtodocumentmedicationsthatrequiredilutionor reconstitutionfromapowderformpriortopreparationforinjection.Ittracksfrequentlydilutedand reconstitutedmedications.TheTabletcomputerpromptsthecliniciantoconfirmwhetheradrughas beendilutedorreconstituted.Ifnot,nouseractionisrequired. NOTE Reconstituteddrugsdonotdisplayadosevalueuntiltheclinicianmodifiesthe medication. 5. Tospecifyadilutionorreconstitution,pressModifyontheSelectMedicationpopup.Or pressonthedoseflag(AnesthesiaViewflowsheet)ordoserow(Nursingview)andpress Modify. 6. ChangethemedicationconcentrationordosebypressingtheConcentrationbox,thenenterthe 41 concentrationvalueusingthenumericalkeypad. 7. Reviewthenumbersentered,thenpressSavebuttontorecordthenewvalue.(IFU017)This changewillbereflectedinthemedicationadministrationhistory. Figure 23 Modify Selected Medication SpecifyingaMixedMedication(Cocktail) Addingtwomedicationsintoonesyringeiscalledamixedmedicationorcocktail.Dependingonyour institution,mixedmedicationsmayincludethefollowing:
Propofol/lidocaine Propofol/fentanyl Propofol/ketamine Neostigminemethylsulfate/glycopyrrolate Atropine/edrophonium Narcan/edrophonium TheTabletcomputerprovidesasimpleapproachtodocumentmixedmedications.Ittracksfrequently mixedmedications,anditpromptsthecliniciantoconfirmwhetheradrughasbeenmixed.Ifnot,no useractionisrequired. 1. Tospecifyamixedmedication,pressCocktailontheSelectMedicationpopup.Orpresson thedoseflag(AnesthesiaViewflowsheet)ordoserow(Nursingview)andpressCocktail. 2. TheModifySelectedMedicationpopup(Figure24)displaystwomedicationnames;withthe firstonealreadyidentified. 3. SelectthesecondMedicationfromthelist.Iftheintendedmedicationisnotlisted,press MoreandtheclinicianmayidentifythecorrectmedicationfromtheFrequentUseor perioperativedruglibrarylist. 42 Figure 24 Cocktail Medication 4. Enterthevolumeinjectedforeitherdrug.TheTabletcomputerwillcalculatethevolumeforthe othermedicationusingthetotalvolumeinjected. 5. PressSave. AddingManualInjection(forPaperAnesthesiaRecords) TheTabletcomputerprovidesthemeanstodocumentIVinjectionsgivenpriortoactivatingan IntelliportdeviceorgiventhroughanIVportotherthantheIntelliportdevice.(ICU016) 1. PresstheAddbutton,thenpressAddInjection.TheFrequentUsemedicationlistwill display. 2. Highlightthedesiredmedicationandconcentration.Indicatethevolumeordose. 3. Changethetimebypressingontheappropriatearrowstothecorrecttimeofadministration. 4. PressSaveandthemedicationwilllistinthemedicationhistoryareaattheindicatedtime. NOTE Amedicationadministrationtimecannotbeinthefuturenormorethanonehour beforethefirstIntelliportdevicehasbeenactivated. AddingInfusions(forPaperAnesthesiaRecords) TheTabletcomputerprovidesthemeanstodocumentinfusions. 1. PresstheAddbutton,thenpressAddInfusion. 2. TheInfusionmedicationlistwilldisplayhavingfourcategories:Fluids,Medications,Titratable Medications,andBloodProducts.Selecttheappropriatecategory. 43 Figure 25 Add Infusion 3. Selecttheappropriateinfusion,bagsizeandconcentration.PressSave. 4. Specifyatimepoint.Tochangethetime,pressthearrowsofthehourandminutesupto increaseanddowntodecrease. Figure 26 Modify Infusion NOTE Amedicationadministrationtimeforaninfusioncannotbeinthefuturenormorethan onehourbeforethefirstIntelliportdevicewasactivated. 5. Specifytheamountinfusedasofthattime(Optional). 6. PressSave. Acliniciancanaddthevolumeinfusedforacareareaatanypointduringacasebypressingonthe infusionbar,enteringvolumeinfusedandpressSAVE.Tostopaninfusion,presstheStopbutton andpressSave.Inactiveinfusionswilldisplayablackbarandthetimetheinfusionwasstopped. 44 AddingaComment(forPaperAnesthesiaRecords) Acommentisafreetextentrythatisrelevanttotheanesthesiarecord.TheTabletcomputersupports fourmethodstoaddtoacomment:
Allergiescommentsforaspecificdrugallergy.Tomakeacommentontheallergypopup screen,highlighttheallergymedication,thenpressCommentbutton.Thiswillautomatically displayakeyboardalongwithstandardcommentoptions.Thecliniciancanpressoneofthe standardoptionsortypeacommentandpressSave.Therecordedcommentisdisplayedwith eachallergypopup.(TheallergypopupscreenisdisplayedonPatientSetuporbypressingthe Allergiesbuttoninthelowerrightcorner.) Timecommentstiedtoaspecifictimeduringacase.Toaddageneralcommentforacase, presstheCommentbuttonandakeyboardwillpopup.TypethecommentandpressSave. TherecordedcommentdisplaywheneveryoupressCommentbuttonandwillbelistedasa CaseCommentintheclinicalreport. Injectionscommentforaspecificdrugadministration.Tomakeacommentaboutaninjection, pressamedicationadministrationeventinthemedicationhistory.ThiswilldisplaytheModify SelectedInjectionpopup.PresstheCommentbuttoninthepopuptodisplayakeyboard. TypethecommentandpressSave.Thiscommentwilldisplaynearthedose/timewhenthe commentwaswritten. Infusionscommentforaspecificdrugadministration.Tomakeacommentonaninfusion, pressaninfusionevent.ThiswilldisplaytheModifySelectedInfusionpopupscreen.Press theCommentbuttontodisplaythekeyboardtotypeacomment.Typethecommentand pressSave.Thiscommentwilldisplaynexttotheinfusionevent. Figure 27 Add Comment TransferPatientsfromOneCareAreatoAnother ItisimportanttopreparethepatientandTabletcomputerpriortomovingthepatientfromonecare areatoanother.PressingPauseCasefromtheMenuinstructstheTabletcomputertodisconnectthe IntelliportdevicetherebyenablinganotherTabletcomputerinasubsequentcareareatoconnecttoit. TheIntelliportdevicewillremainwirelesslyconnectedtotheearliertabletifPauseCasehasnotbeen pressedandthepatienthasbeenmovedtoasubsequentcarelocationthatiswithin30feetofthe earlierTabletcomputer.Inthissituation,thecliniciancandisconnecttheIntelliportbypressingShow AllfromthePatientSetupscreenandfollowingthescreeninstructions. 45 WorkingwithOrders TheAnesthesiaSystemsupportsmedicationordersathospitalsthatuseComputerizedPhysicianOrder Entry(CPOE).WheninjectionsaregiveninperioperativenursingcareareasthatuseCPOE,theTablet computercanmatchtheinjectiontoaphysicianorderandsendthisinformationtothehospitalsclinical informationsystem.ObservethefollowingstepswhentheAnesthesiaSystemisconfiguredfor medicationordersinthenursingcareareas:
1. Reviewthepatientsmedicationorderattheclinicalinformationsystem. 2. PreparethesyringeandIntelliportdeviceforuse. 3. AttachthesyringeforthemedicationordertotheIntelliportdevice. Foranencodedsyringe,theTabletcomputercomparesthemedicationintheattachedsyringeto pendingmedicationordersanddisplaysapopupconfirmingamatch.Verifythemedicationorder matches.Ifcorrect,pressSelect.Ifincorrect,pressSelectOther. Figure28MedicationOrders Foranunencodedsyringe,theTabletcomputerdisplaysapopuplistingtheactivemedicationordersfor thepatientandpromptsthecliniciantoselectthemedicationcorrespondingtotheattachedsyringe. HighlightthemedicationorderandpressSave. 46 Figure29SelectinganOrderwhenUsingUnencodedSyringes RespondingtoMessages TheAnesthesiaSystemprovidestwotypesofmessages:"System"and"Clinical."Clinical"messagesare alertsandremindersthatrelatedirectlytoanaspectofpatientcaredelivery(e.g.contraindicationor areminderthatitmaybetimetoredoseantibiotics).Systemmessagesprovidestatusonrelevant systemoperatingparameters. Messagesprovideinstructionsandabuttonforacknowledgingorresolving.RefertoAppendixXfora listofmessages.MessagesdisplayintheMessagesectionoftheTabletcomputeruntiltheyare acknowledgedorarenolongerclinicallyrelevant.Messagescanbeansweredanytimeduringacase. Priortopausingorclosingacase,aclinicianispromptedtorespond/answerunresolvedmedication messagesgeneratedduringthecase. ClinicalMessages AllergyalertAnallergyalertdisplayswhenaclinicianattachesanencodedsyringeorselectsa medicationforanunencodedsyringetowhichthepatienthasaknownallergy. AntibioticredosingreminderTheTabletcomputertrackselapsedtimesinceanantibioticis administeredanddisplaysanantibioticredosingmessageiftheconfiguredredosingintervalhas elapsed.Theredosingintervalisindividualtoeachantibiotic,anditisconfiguredinthedrug library. MedicationTheTabletcomputertracksmedicationsgiventhatarereconstituted,dilutedor givenascocktails,(mixedmeds)anddisplaysamessageforthecliniciantospecify.The messageisindividualtoeachmedication,anditisconfiguredinthedruglibrary. 47 ReviewingtheMedicationRecord(forPaperAnesthesiaRecords) TheAnesthesiaSystemrequiresthecliniciantoreviewthemedicationrecordforaccuracypriorto printingareport.Thisiscalledfinalizinganditensurestheaccuracyofthereport. NOTE Aclinicianisabletocorrectandamend(addinginformationto)thepatientsthe medicationrecordsolongasanIntelliportforthatpatientisconnectedandthecase hasnotyetbeenfinalized. 1. FromthemainMenu,PressReports. 2. TheTabletcomputerwillprovideapopupwithmessagesforacliniciantoverifyoradjustthe followingdata:
Checkforreconstituted,dilutedormixedmedicationsgiven.Amessageisindividualtoeach medication,anditisconfiguredinthedruglibrary. Checkformissinginfusiondata Checkformedicationsgiveninnursingareasbyananesthetistthataretobechartedinthe anesthesiarecord ClockadjustmentPressClocktoadjustthetimefortheprintedreportstosynchronizean anesthetistclockwiththeflowsheet.Apopupdisplaysshowingaclockwithupanddown arrowsforhoursandminuteadjustment.PressSave Figure30ReviewCase 3. Ifthereareunresolvedmessages,thecliniciancancomebackandanswerthequestionsatany timepriortoClosingthecase(CloseCase). 4. PressReviewedCaseandPrint.Oncefinalized,themedicationadministrationhistoryfor recordedmedicationadministrationswillnolongerbeeditable. Ifallquestionsarenotansweredpriortocaseclosure,thecliniciancancomebackandanswerthe questionsupto24hoursafterthecaseisclosed.Ifthe24hourwindowisexceeded,thecasecanonly 48 beprintedoutandchangesmanuallymadewithapen,signedanddatedbytheclinicianandsubmitted toMedicalRecordstobeattachedtothepatientselectronicrecord. PrintingaReport(forPaperAnesthesiaRecords) Thefollowingreportsareavailableforprinting:
AnesthesiaFlowSheetRecordThisreportlistsofthemedicationsandinfusionsprovided duringtheORsuiteinaflowsheetformat.ThisiscomparabletotheAnesthesiaRecordthatis manuallyrecordedbyanesthesiologistsforallcases. ControlledSubstanceUsageThisreportprovidesalistofallcontrolleddrugsusedduringthe ORcase,withdoseamount,mLsusedandtimegiven. HandoffThisreportisusedasacommunicationtooltoconveyinformationpertinenttothe ongoingcareofthepatient,especiallywhenthepatienttransfersfromonecareareatoanother andanewprimarycaregiverassumescareofthepatient. PerioperativeMedicationAdministrationThisreportlistseachmedicationandfluid administeredshowingthetime,dosageandroute.Italsoprovidesasummaryshowingtotal dosagebymediationandfluid. 1. Toprintareport,pressReportsfromtheMenu. Figure 31 Print Reports 2. Selecttheappropriatereporttoprint. 3. Specifytheprinter,ifdifferentfromdefault,andthenumberofcopies. 4. PressPrint. AddressPendingMedications(EMRIntegration) WhenconfiguredforEMRintegration,theTabletcomputersendsmedicationadministration informationinrealtimeunlessinformationismissing.Themissinginformationincludesthedrug name/concentrationofanunencodedsyringe,thedoseofareconstituteddrug,oruseofacocktail.In 49 thesesituations,theTabletcomputerretainsthismedicationadministrationinapendinglistuntilitis resolvedbytheclinician. NOTE Itisgoodpracticetoresolvemedicationadministrationspriortoacaretransitionor closingacase.(IFU032) 5. FromtheMenu,pressPendingMeds.Apopuplistsmedicationadministrationsthatrequire resolution. 6. Presseachitemtoresolve.Aseachresolutiononmedicationoccurs,thequerywilldisappear andaresultingmedicationmessagewillindicatetheinformationsenttotheAnesthesia InformationManagementSystem(AIMS)system. DeactivateIntelliport,DisposeofIntelliportSensor,andPrepareIntelliportBaseforReuse 1. WhentheIntelliportdeviceisnolongerinuse;disconnecttheIntelliportSensorfromthe IntelliportBasebysqueezingtogetherthetwofingertabsontopoftheIntelliportSensorwhile liftinguptodisengagefromtheIntelliportBase. 2. Whenproperlyseparated,theIntelliportdevicewillpoweroffandnolongertransmits wirelesslytoaTabletcomputer. 3. DisposeoftheIntelliportSensoraccordingtoyourhospitalsmedicalwasteprotocols. NOTE AvoidinadvertentlydiscardingtheIntelliportBaseafteruse.Itisintendedforreuse withmultiplepatients. 4. CleananddisinfecttheIntelliportBase.Firstcleanitwithacommercialhospitaldisinfectant andsecondly,disinfectitsecondlywithacommercialhospitaldisinfectant.Follow manufacturersinstructions.Foralistofapprovedhospitalapprovedproductstouse,referto AppendixX. 5. Allowittodry. 6. InspecttheIntelliportBaseforcracksordamage.Ifdamageisevident,thendisposeofit accordingtoyourhospitalsprotocols. 7. ConnecttheIntelliportBasetotheRecharger. NOTE Ittakesapproximately24hourstofullyrechargeanIntelliportBasewhendischargedto
<25%ofpower. 8. IftheIntelliportBasehasexceededitsUsefulLife,thendisposeofitaccordingtoyourhospitals protocolsforelectricalwaste.TheIntelliportBasecontainsaLithiumbattery. NOTE TheIntelliportBasewillilluminatearedlightwhilechargingifithasexceededitsUseful Life. PowerDowntheTabletcomputer TheTabletcomputermayremainpowereddownbetweenuses. 1. ConfirmtheTabletcomputerdoesnothaveIntelliportdevicesconnectedanditisnolongerin use. 2. PresstheShutdownbuttonlocatedontheMenubar. 50 3. PressYes,toconfirmandpowerdowntheTabletcomputer. 51 Section V Troubleshooting IntheeventyouexperiencedifficultyoperatingtheAnesthesiaSystem,thissectionofthemanual providesatroubleshootingguideforoperationalproblems.Iftheresponsetoaspecificquestionisnot found,contactyourServiceRepresentative:
Phone:
Website:
Email:
Question Answer HowdoIreturntotheClinical MainScreenorHome?
WhatdoIdoiftheBatteryin theBaserunsoutofcharge duringacase?
FromMainMenupressAnesthesiaorNursingview. ABasecanbeexchangedatanytimewithoutaffectingthecase. Exchangestakelessthan30seconds.Ifitismorethan30seconds,the casewillrequireresynchronizationofIntelliportdevicetoTablet computer. WhatifIpressedCloseCase orShutdownbymistake duringanactivecase?
OnceyouresynchronizethepatientandIntelliportdevicetothe Tabletcomputer,allinformationisretrievable,eveniftheIntelliport Sensorisreplaced. Itisnotpossibletolosehistoricalmedicationinformationifthe IntelliportdeviceandpatienthavebeensynchronizedtotheTablet computer.MedicationsgivenpriortoIntelliportsynchronizationare retainedinmemoryontheIntelliportBase. Ifithasnotbeenmorethan24hourssincetheORcase,thecasecan beretrievedfromthehospitalserverandeditingofthecasecan occurviaaTabletcomputer.However,ifgreaterthan24hours,the casereportcanbeprinted,andmanualeditsmadewithdatesand signaturesandreturnedtoMedicalRecordsforacaseupdate. AnIntelliportSensorcanbereplacedatanytime.Resynchronization isrequired. GotoMainmenuandpresstheRemovePatientbutton.TBD. Whatcausesmetolose historicalmedication information?AndwhatcanI dotoretrieveit?
WhatifIforgottocharta medicationoridentifya SelectMedandthepatient isnowintheMedSurgflooror ICU?
WhatdoIdoiftheIntelliport Sensornolongerisworking andthecaseisnotover?
WhatifthecaseisoverandI justnoticedthewrongpatient appearsonthescreen?
52 Section VI Care and Maintenance ObservethefollowingproceduresforcareoftheAnesthesiaSystem.ComponentsoftheAnesthesia Systemdonotrequireusermaintenance.Therearenouserserviceableparts. Care CleanandDisinfecttheIntelliportBaseforReuse 1. CleantheIntelliportBasewithacommercialhospitaldisinfectant.ThendisinfecttheIntelliport Basewithacommercialhospitaldisinfectant.(IFU0024)Foralistofapprovedhospitalcleaning productstouseontheIntelliportBase,pleaserefertoAppendixB. 2. Allowittodry. 3. InspecttheIntelliportBaseforcracksordamage.Ifdamageisevident,thendisposeofit accordingtoyourhospitalsprotocols. RechargingtheIntelliportBaseforReuse 4. PlugtheRechargerintoanisolatedACoutlet. 5. AttachtheRechargertoacleananddisinfectedIntelliportBasebyjoiningtheRechargerand IntelliportBasefrontsectionsfirst,thensnapthetwotogether.Oneshouldaudiblyhearthe snap. 6. VerifyproperseatingofRechargertotheIntelliportBasebycheckingforacharginglighton theIntelliportBase.Ifthisisnotseen,viewtheIntelliportdeviceonitssidetodetermineifthe twoareproperlyconnected.IfaspaceisseenbetweentheRechargerandIntelliportBase,then separateandreattachedproperly. 7. TheIntelliportBasewillilluminateshowingtheamountofchargeinthebattery.Refertothe followingsectionshouldaredindicatorlightilluminate. NOTE Fourbarsindicateafullcharge.TheIntelliportBaseisnotdamagedwhenleftonthe Rechargerafterbeingfullycharged. CleananddisinfecttheRechargerbyusingtheprocedureusedfortheIntelliportBase. DeterminingUsefulLifeforaIntelliportBase TheIntelliportBaseisdesignedtobereusable.After500uses,thecomponentsmaybesusceptibleto wearanditisnolongersuitableforusewithpatients.Usethefollowingproceduretodetermineifan IntelliportBasehasexceededitsusefulLife. NOTE AvoidusinganIntelliportBasethathasexceededitsUsefulLife. 1. ConnecttheIntelliportBasetoaRecharger. 2. IftheIntelliportBasehasexceededitsUsefulLife,thentheIntelliportBasewillilluminateared lightwhilecharging.Ifso,discontinueuse. NOTE IfanIntelliportBasehasexceededitsUsefulLife,thendisposeofitaccordingtoyour hospitalsprotocolsforelectricalwaste.TheIntelliportBasecontainsaLithiumbattery. 53 ShouldanIntelliportBasebeusedafterithasexceededitsUsefulLife,amessagewilldisplaywhenthe IntelliportdeviceiswirelesslyconnectedtotheTabletcomputerduringPatientSetup.Shouldyou experiencethismessage,replacetheIntelliportBasewithanotherandrepeatthewirelessconnectionto theTabletcomputer. CleaningtheTabletcomputer TurntheTabletcomputeroffanddisconnectthepowercable. 1. 2. CleantheTabletcomputerwithasoftclothdampenedwithwater.Moistenasoft,lintfreecloth witheitherwateroradisplaycleaner,andwipethesurfaceoftheTabletcomputeruntilitis clean. Donotuseaerosolcleaners,whichmaycontainflammablesubstances. DonotallowwaterfromtheclothtoseepdowntotheTabletcomputerportsandthe buttons. ToavoiddamagingtheTabletcomputerordisplay,donotspraycleaningsolution directlyontothedisplay. OnlyuseproductsspecificallydesignedforcleaningTabletcomputers,andfollowthemanufacturers instructionsthatareincludedwiththeproduct.Foralistofapprovedhospitalcleaningproductstouse onyourTabletcomputer,pleaserefertoAppendixF. Storage ComponentsoftheAnesthesiaSystemdonotrequireusermaintenance.Therearenouserserviceable parts.ContactTechnicalSupportintheeventaTabletcomputerorIntelliportBaseisnotfunctioning properly. Tabletcomputer Whennotinuse,theTabletcomputermayremainmountedandpoweredon,whenconnectedtoan isolatedACpowersource. NOTE DonotremovetheTabletcomputerfromitsprotectivecaseforstorage. IntelliportBase Whennotinuse,acleananddisinfectedIntelliportBaseshouldremainontheCharger. NOTE NOTE DonotplaceanIntelliportBaseinstoragewithoutfirstcleaninganddisinfecting accordingtoHospitalpolicy. ForhospitalsthatkeepaspareIntelliportBaseintheOR,besuretoperiodicallyswap outIntelliportBasetoensureitisfullycharged. 54 IntelliportSensor IntelliportSensorsarestoredinthesterilepackaging. IntelliportSensorshaveaUseBydatetoensuresterility.DiscardIntelliportSensors thathavenotbeenusedbytheirUseBydate. Maintenance ComponentsoftheAnesthesiaSystemdonotrequireusermaintenance.Therearenouserserviceable parts.ContactTechnicalSupportintheeventaTabletcomputerorIntelliportBaseisnotfunctioning properly. AdministrationandService ToBeDetermined 55 Section XIII. Appendix AppendixAIntelliportTechnicalSpecifications Specification Description Fluidconnection 2ports,Luerlocktypefittings Volumemeasurementaccuracy Injectionportcapacity Primevolume 5%
100injections 5mL Deadvolume/retainedfluid 0.3mLfollowinginjection Exteriorsize(excludingtubing)
<4.5cubicinches Weight 72gm(IntelliportBaseandIntelliportSensor) OperationonaSinglecharge 24hours Rechargespeed Upto4hoursfrom<25%
Wirelessrange(Intelliportdevice) 5m OperatingTemperature OperatingHumidity 12C40C(IFU014) 20%to85%relativehumidity(IFU015) ShippingandStorageTemperature 20C60C ShippingandStorageHumidity 15%to90%relativehumidity 56 AppendixBDisinfectantAgents ThefollowingdisinfectantsaresuitableforusewiththeIntelliportBaseandRecharger. Disinfectant Typeofdisinfectant CaviWipes1(ByMetrex) Alcoholbasedquaternaryammonium SuperSaniCloth(purpletop)(byPDI) Alcoholbasedquaternaryammonium 57 AppendixCStandards TheAnesthesiaSystemisintendedforuseunderthesupervisionofhealthcareprofessionalsonly.Thisis aClassIImedicaldevice.TheAnesthesiaSystemconformstothefollowingstandards. IEC606011 MedicalElectricalEquipmentPart1.GeneralRequirementsforSafety IEC6060112 CollateralStandard:ElectromagneticcompatibilityRequirementsandtesting 58 AppendixDGlossary ThefollowingtermsareusedintheseInstructionsforUse. Configuration ThewaytheAnesthesiaSystemissetup,ortheassortmentofcomponentsthat makeuptheAnesthesiaSystem.TheGatewaymanagestheconfiguration settings.AllTabletComputersforacareareahavethesamesettings,exceptfor wirelessandprinters. EMRintegrated mode Systemconfigurationthatsupportsintegrationwithelectronicmedicalrecords orperioperativeinformationmanagementsystems(PIMS) EncodedSyringes Syringeshavingaspecialbarcodeidentifieronthetip Encoding Gateway Aspecialbarcodeidentifieronthetipofprefilledsyringes AsoftwareapplicationthatenablestheAnesthesiaSystemtofunctionasan enterprisedeviceandinformationsystem.TheGatewayprovidesacentralhub towhichallTabletcomputersconnectviathehospitalnetwork.Italsoincludes aninterfaceenginefortheAnesthesiaSystemtoexchangedatawithother networkedhospitalinformationsystems,alongwithasuiteofutilitiesforgeneral Gatewayimplementation,operation,andmaintenance. Injectionport ThesplitseptumportontheIntelliportSensorwherethesyringeattaches IntelliportBase Intelliportdevice TheIntelliportBaseisanonsterile,reusabledevicethathousestheelectronics andwirelesstransmitter.Itisbatterypowered,andrechargeable.Aseparate ChargerrechargesthebatteryinthereusableIntelliportBasepriortoeachuse. Anintelligentinjectionport.Itattachestoaninjectionsite(YSiteorstopcock) formanuallyadministeredIVinjections.ItiscomprisedofaIntelliportSensor andaIntelliportBase,whichsnaptogetherpriortouse. IntelliportSensor AIntelliportSensorisasteriledisposabledevicehavinganinjectionportanda Luerconnection.TheIntelliportSensorissuppliedinasterilepackageforsingle patientuse. Luerlok Astandardfittingusedformakingleakfreeconnections.Aluerfittingthat securelylockstogetherusingthreads. Nonencoded syringes Syringesthatdonothavespecialencodingonthetip.TheIntelliportdevice cannotidentifythedrugcontentsofthistypeofsyringe. PerioperativeDrug Library TheAnesthesiaSystemoperatesusingthehospitalsperioperativedruglibrary. TheGatewaymanagesthedruglibrary.Whenanunencodedsyringeisattached, thepicklistisderivedfromtheperioperativedruglibrary. Recharger AseparateRechargerrechargesthebatteryinthereusableIntelliportBaseprior toeachuse. Standalonemode Systemconfigurationthatsupportsapaperanesthesiarecord 59 Tabletcomputer AcommercialTabletcomputerwithembeddedsoftwarefortheAnesthesia Systemoperation.Itcontinuouslycapturesanddisplaysthemedication administrationrecord(MAR)datafromtheIntelliportdeviceeachtimean injectionoccurs.Italsoenablesclinicianstomanuallydocumentotherpertinent clinicalinformation,anditprovidesclinicaldecisionsupporttohelpimprove safetyandaidcliniciansduringtreatment.Informationtechnologywirelessly transfersthedatatotheGateway. 60 AppendixEASADrugCategoryColorSchema 61 AppendixFMessages 1. Name&Trigger Tabletcomputersoftwareisunableto verifyitsconfigurationsettings(e.g. nowirelesstoGateway) 2. WhiletheTabletcomputersoftwareis receivingandupdatingtheTablet computersoftwareConfiguration Profile. 3 WhiletheTabletcomputer softwareis receivingandupdatingtheDrug Formulary. 4 Configurationupdatenotsuccessful IntelliportBaseEndofLife Intelliportdevicetransmits#ofuses uponsynchronization. Drugconnectedorsubsequently identifiedmatchesacontraindicated drugbasedonthepatientsallergy Antibioticredosingintervalexceeds configurationvaluefortheantibiotic. 5 6 7 8 9 MessageText Softwareconfigurationor formularyversionscannotbe verified.Usingcurrentsettings. Notifyyoursystem administrator. UpdatingDPM,configuration toversion[xx]. ClearingtheMessage Persistswithbootup screen. Willtimeoutin10 seconds. Persistswhileupdating file(s) UpdatingFormularytoversion
[xx]. Persistswhileupdating file(s) Newconfigurationsettingsnot updated.Usingcurrent settings.Notifyyoursystem administrator. Intelliportdevicehasreached itsendoflife Screen[Drugname]
PotentialAllergyReaction Patienthasaknownallergyto:
[allergydescription]
Severity:[severity]
Reaction:[reaction]
[AntibioticDrugName]given X.Xhoursago.Consider redosing. Persistswithbootup screen OKclearsthemessage Confirm(completes patientassociation) OKbutton Automaticallyupon syringedisconnectifnot pushed. OKbutton Automaticallyupon subsequentantibiotic injectionconnected/
identified. PressingtheDilution messagetextopensthe manualinjectionentry screenwithvolumeand dosefieldseditable. PressingtheMixed messagetextopensthe manualinjectionentry Thedrugconnectedorinjectedhas beenidentifiedasfrequentlydiluted inconfiguration. PressHereif[DrugName]was dilutedbeforegiven. Thedrugconnectedorinjectedhas beenidentifiedasfrequentlymixedin configuration. PressHereif[DrugName]
wasmixedbeforegiven. 62 Name&Trigger MessageText 10 Tabletcomputersoftwarereceives unmeasuredinlieuofvolumefrom theIntelliportdevice Amountinjectednot measured.PressHereto enterthevolumegiven. 11 Intelliportdevicetransmitsalow batterymessage LowIntelliportbattery(10%
remaining).ReplaceIntelliport Base. 12 13 14 15 16 17 18 19 20 Intelliportdevicetransmitsapowering downmessage LowIntelliportbattery. Intelliportdevicepowered down. Tabletcomputerhaslessthan20 minutesofpowerremaining LowTabletcomputerbattery.
(10%remaining). Tabletcomputersoftwarepowering downmessage AnIntelliportdeviceisnolonger communicatingwiththeTablet computersoftwareafter5secondsof pollingbytheTabletcomputer software AnIntelliportdevicehasbeen connectedcommunicatingwiththe Tabletcomputersoftwareafterpolling bytheTabletcomputersoftware. Intelliporterrorconditiontransmitted toTabletcomputersoftware Intelliporterrorconditiontransmitted toTabletcomputersoftware Tabletcomputersoftwareerror conditionpresent UserpressesShutDownbuttonwith noIntelliportdevicessynchronized. LowTabletcomputerbattery. Tabletcomputerpowering down. Intelliportwirelessconnection lost. Intelliportwirelessconnection restored. Intelliporterroroccurred. ReplaceIntelliportBase. Tabletcomputererror occurred.RestartTablet computer. Tabletcomputererror occurred.RestartTablet computer Tabletcomputershutting down. 63 ClearingtheMessage screenwithfieldsfora seconddrug. PressingtheNot Measuredmessagetext opensthemanual injectionentryscreen withcursorfocuson volumefield. Automaticallyupon Intelliport unsynchronizationor IntelliportBase replacement. Automaticallyupon synchronizationof Intelliportdevicehaving lowbattery. Automaticallywhen TabletcomputeronAC power N/A Automaticallyupon Intelliport synchronizationofsame serialnumberIntelliport Sensor/IntelliportBase. 1minutetimeout. PressClearif resolved OKbutton. PressClearif resolved OKbutton PressClearif resolved N/A 21 22 23 24 25 26 Name&Trigger UserpressestheShutDownbutton whileanIntelliportdeviceis synchronized. UserpressesPrintbuttonon ReportingScreen Failedlogin.UserNameandPassword combinationnotvalid DoseexceedsorderedDose IntelliportSensornotprimed.No SensorsignalatinitialIntelliport Sensorattachment AirdetectedintheIntelliportSensor. Occursafterproperprimingwithfluid andairentrappedintheIntelliport Sensor. MessageText ShutDowntheTablet computeranddisconnectthe Intelliportdevice?
PrintingtoXXXprinter. ClearingtheMessage Yescontinuewith shutdown Nocancelshutdown N/A TextprovidedbyGatewayor IncorrectPassword.Reenter. Checkdoseonorder PrimeIntelliportSensor beforeuse Nextloginattempt Syringeisdisconnected IntelliportSensorsignal levelachieved. AirdetectedintheIntelliport Sensor. IntelliportSensorsignal levelachieved.
(returned) 64 AppendixGAccessories Charger(partnumber2284)ThisaccessoryisusedtorechargetheIntelliportBasein preparationforreuse. Radio(partnumber2285)ThisaccessoryisusedbytheTabletcomputertocommunicatewith Intelliportdevices. 65 AppendixHRadioFrequencyWirelessTechnology TherearetwowirelesstechnologiesusedintheAnesthesiaSystemasdepictedinFigureXbelow. Intelliport 2.4 GHz. - Medication administration data to/from Intelliport to Tablet Computer Hospital Wireless Network Gateway TabletComputer 802.11 - Clinical Data to/from Tablet to Gateway Theradiofrequency(RF)signalpowerhasbeenlimitedtoaverylowleveltonegateany electromagneticpotentialinterferenceincoexistencewithothermedicaldevices.Bothwireless technologiesutilizedhavebeenapprovedforusebythe(FederalCommunicationsCommission)FCCand meetFederalEMCandEMIguidelines.IntheeventofapotentialsignallossoftheseRF communicationsalostwirelesslinkmessagewillbedisplayedontheTabletcomputertoinformthe operator.TheTabletcomputerwillindicatewhencommunicationsareresumed.Informationonproper setup,configurationandperformancewiththeHospitalNetworkisprovidedattimeofsystem installation.NosetupisrequiredforIntelliportdevicetoTabletcomputercommunications. Confirmationofappropriatepatientidentificationisrequired. Othermedicalequipmentsuchasanelectrosurgicalunit(ESU)maybrieflyinterfere withthesewirelesscommunications.Communicationsshouldautomaticallyresume aftertheinterferenceandlostmessageswillberesent.TheTabletcomputerwill indicatewhenlostcommunicationsexist.TheIntelliportstatusindicatorwilldouble blinkwhencommunicationwiththeTabletcomputerislost. IntelliporttoTabletcomputer TheTabletcomputerusesanIntelliportRadiotowirelesslycommunicatewiththeIntelliportdevice usinganRFsignalat2.4GHztoformalocalmedicaldevicenetwork.AnumberofIntelliportdevices andTabletcomputersmaybeusedinthesamevicinitysuchasaPreoperativecareareaoraPACU.A licensehasbeenissuedbytheFederalCommunicationsCommission(FCC)tooperatethismedical deviceinhospitalsandclinics.TestinghasbeenperformedtodemonstrateconformancetoIEC606011 2forthecorrect,timelyandsecuretransmissionofmedicaldata(injecteddrugidentificationcodesand volumemeasurements)andalertmessages.AlertmessagesarecommunicatedbetweentheIntelliport deviceandtheTabletcomputertoadvisetheUserofvariousoperationalcharacteristicsofthesystem. Someofthesealertsinformtheoperatorofpotentialhazardoussituationstoallowuseractionto preventharmtothepatientorlossofmedicaldata. Intelliportdevicesusingproprietary2.4GHztechnologyareassociated(linked)withspecificpatients usingtheTabletcomputerIEEEstandardsbasedon802.11a/b/n(2.4GHz5GHz)technology.TheUser identifiestheIntelliportSensorbyserialnumberandselectsaspecificpatientfromthehospitalspatient 66 listing.AllmedicationadministrationdatafromtheIntelliportdeviceistransferredtothespecific patientsmedicalrecord.Intheeventofacommunicationloss,medicationadministrationdatawillbe storedlocallyattheIntelliportdeviceandtransferredtotheTabletcomputerwhencommunicationsare resumed. TabletcomputertoGatewaythroughtheHospitalNetwork TheTabletcomputerwirelesslycommunicateswiththeexistingHospitalNetworkusingastandards basedIEEE802.11a/b/g/nenterpriseWLANnetwork.ThenetworkingtopologythatincludesthisTablet computerwillfollowthebestofpracticedeploymentguidelinesthatcomplieswiththerightqualityof service(QoS)andsecurity.TheGatewaysoftwareandaccompanieddatabasewillbeapartofthe hospitalsenterpriseinformationsystem.AnumberofTabletcomputersmaybeconnectedtothe healthcareenterprisewirelessnetworkandtotheintendedGatewaysoftwareanddatabase.The GatewayandaccompanieddatabaseprovidesalistofpatientsfortheUsertoselectandaFormulary libraryofmedicationsandfluidsforinjectionorinfusion.Actualmedicationandfluidadministration dataissenttotheGatewayandaccompanieddatabaseforrecordkeeping.Oncerecordedonthe Gatewayandaccompanieddatabasethisdataisautomaticallyavailableinothercareareaswhenthe patientistransferredandtheIntelliportdeviceiswirelesslyconnectedtoaTabletcomputer. SummaryofIEC6060112TestingandSpecifications Specifications IntelliporttoTabletcomputer TechnologyType 2.4GHzproprietarymessaging TabletcomputertoHospital NetworkandGateway 802.11ab,g,nsecurewireless connectionwiththecorrectqualityof service(QoS) EffectivePower Effectivetransmission distance Datathroughputand latency LostCommunications MessageontheTablet computerdisplay Limitations FCCLicense Limitationsfoundduring testingtoIEC6060112 10metersorless Xxmeterstohospitalwirelessaccess point(WLANAP) Realtimeinformation,nodelays Subjecttohospitalnetwork performance Intelliportcommunicationlost Gatewaycommunicationlost 3IntelliportdevicestooneTablet computer 200TabletcomputerstoHospital NetworkandGateway
Xxxx
NottestedconformstoIEEE802.11 standards. 67 QualityofService WirelessCoexistence Securityofwireless signal/data EMCinformation 68 AppendixIReferenceDocuments AvailabledocumentationandtrainingfortheAnesthesiaSystemincludes:
OrderNumber DocumentName 2300 XXXXX XXXXX AnesthesiaSystemInstructionsforUse AnesthesiaSystemQuickReferenceCards UserTrainingVideoandDVD 69 AppendixJDescriptionofSymbols ThefollowingsymbolsareusedbytheAnesthesiaSystem. Description Warnings IngressProtectionfromfallingwaterdrops Refertouseroperatinginstructions Donotuseifpackageisdamagedorprotectorcapisunattached. TypeBF/DefibrillationProofappliedpart SingleUseOnly.Donotreuse!
Identifiesthecomponentmanufacturer Keepdry Uppertemperaturelimit ExpirationDate,endofshelflifeDecember,2013 Lotnumber Symbol IPX2 Sterile EO SuppliedSterile,EthyleneOxidegas 70 BectonDickinson 1BectonDrive FranklinLakes,NJ07417 Phone:(xxx)xxxxxxx Fax:(xxx)xxxxxxx RevisionDate:2/21/2013 PartNo.:
2300_R1FCCIC 71
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2014-03-06 | 2402 ~ 2480 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2014-03-06
|
||||
1 | Applicant's complete, legal business name |
CRISI Medical Systems
|
||||
1 | FCC Registration Number (FRN) |
0023326200
|
||||
1 | Physical Address |
9191 Towne Centre Drive, Ste. 330
|
||||
1 |
San Diego, California 92122
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
s******@nemko.com
|
||||
1 | TCB Scope |
A2: Low Power Transmitters (except Spread Spectrum) and radar detectors operating above 1 GHz
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2ABS9
|
||||
1 | Equipment Product Code |
RADIO2
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
W****** B****
|
||||
1 | Title |
VP Product Development
|
||||
1 | Telephone Number |
76050********
|
||||
1 | Fax Number |
none********
|
||||
1 |
w******@crisimed.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Manual Injection monitoring system for anesthesia | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | Yes | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Nemko USA, Inc. - San Diego EMC Division
|
||||
1 | Name |
C****** N****
|
||||
1 | Telephone Number |
613-7********
|
||||
1 |
c******@nemko.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC