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

CRISI Medical Systems Manual Injection monitoring system for anesthesia

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BDAnesthesiaSystem

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InstructionsforUseManual

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InjectingConfidence™

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ADDLIMITEDWARRANTYANDDISCLAIMERHERE

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Thisdocumentcontainsconfidentialinformation.Nopartofthisdocumentmaybetransmitted,

reproduced,used,ordisclosedoutsideofthereceivingorganizationwithoutthewrittenconsent

ofBectonDickinsonandCompany.

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“Intelliport”and“injectingconfidence”aretrademarksofCRISIMedicalSystems,Inc.

BD,BDLogo,andLuer‐LokaretrademarksofBectonDickinsonandCompany.

CaviWipes1andSuperSani‐Cloth,aretrademarksoftheirrespectivemanufacturers.

ProtectedbyoneormoreofU.S.PatentNos.8,394,053,8,355,753,8,385,972,8,328,082.

Otherpatentspending.

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TableofContents

SECTIONIBACKGROUND.....................................................................................................................8

Introduction..............................................................................................................................................8

ProductDescription..................................................................................................................................8

HowitWorks...........................................................................................................................................10

IndicationsforUse..................................................................................................................................11

IntendedUse...........................................................................................................................................11

SECTIONIISAFETYPRECAUTIONS......................................................................................................12

WarningsandPrecautions......................................................................................................................12

General................................................................................................................................................12

TabletcomputerTabletcomputerTabletcomputer...............................Error!Bookmarknotdefined.

Tabletcomputer.................................................................................................................................13

Intelliportdevice.................................................................................................................................14

SECTIONIIIDESCRIPTIONOFANESTHESIASYSTEMCOMPONENTS.....................................................17

SuppliesandEquipment.........................................................................................................................17

Intelliport................................................................................................................................................17

IntelliportSensor................................................................................................................................17

IntelliportBase....................................................................................................................................18

Recharger................................................................................................................................................19

EncodedSyringes....................................................................................................................................19

Tabletcomputer.....................................................................................................................................20

SoftwareRunninginStandaloneMode..................................................................................................20

AnesthesiaView..................................................................................................................................21

NursingView.......................................................................................................................................23

ButtonandMenuOptions..................................................................................................................24

SoftwareRunninginEMR‐IntegratedMode...........................................................................................27

SECTIONIVOPERATIONS...................................................................................................................30

QuickGuide.............................................................................................................................................30

PreparetheIntelliport........................................................................................................................30

SetuptheTabletcomputer................................................................................................................30

GiveIVinjectionsandViewMedicationAdministrations...................................................................31

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DetailedOperatingInstructions..............................................................................................................32

PreparetheIntelliport........................................................................................................................32

SetuptheTabletcomputer–PaperAnesthesiaRecord.....................................................................32

GiveanIVinjectionUsingtheIntelliportDevice................................................................................37

SpecialActivities.....................................................................................................................................39

SettingUserPreferences....................................................................................................................39

AddingAdditionalIntelliports.............................................................................................................39

MedicationDeliverywithSyringesNotEncoded................................................................................40

SpecifyingaDilutedorReconstitutedMedication.............................................................................41

SpecifyingaMixedMedication(Cocktail)...........................................................................................42

AddingManualInjection(forPaperAnesthesiaRecords)..................................................................43

AddingInfusions(forPaperAnesthesiaRecords)...............................................................................43

AddingaComment(forPaperAnesthesiaRecords)..........................................................................45

TransferPatientsfromOneCareAreatoAnother.............................................................................45

WorkingwithOrders...........................................................................................................................46

RespondingtoMessages....................................................................................................................47

ReviewingtheMedicationRecord(forPaperAnesthesiaRecords)..................................................48

PrintingaReport(forPaperAnesthesiaRecords)..............................................................................49

AddressPendingMedications(EMRIntegration)...............................................................................49

DeactivateIntelliport,DisposeofIntelliportSensor,andPrepareIntelliportBaseforReuse...........50

PowerDowntheTabletcomputer......................................................................................................50

SECTIONVTROUBLESHOOTING.........................................................................................................52

SECTIONVICAREANDMAINTENANCE...............................................................................................53

Care.........................................................................................................................................................53

CleanandDisinfecttheIntelliportBaseforReuse.............................................................................53

RechargingtheIntelliportBaseforReuse..........................................................................................53

DeterminingUsefulLifeforaIntelliportBase....................................................................................53

CleaningtheTabletcomputer............................................................................................................54

Storage....................................................................................................................................................54

Tabletcomputer.................................................................................................................................54

IntelliportBase....................................................................................................................................54

IntelliportSensor................................................................................................................................55

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Maintenance...........................................................................................................................................55

AdministrationandService.....................................................................................................................55

SECTIONXIII.APPENDIX....................................................................................................................56

AppendixAIntelliportTechnicalSpecifications......................................................................................56

AppendixBDisinfectantAgents..............................................................................................................57

AppendixCStandards.............................................................................................................................58

AppendixDGlossary...............................................................................................................................59

AppendixEASADrugCategoryColorSchema........................................................................................61

AppendixFMessages..............................................................................................................................62

AppendixGAccessories..........................................................................................................................65

AppendixHRadioFrequencyWirelessTechnology................................................................................66

AppendixIReferenceDocuments..........................................................................................................69

AppendixJDescriptionofSymbols.........................................................................................................70

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TableofFigures

Figure1AnesthesiaSystemComponents.....................................................................................................8

Figure2IntelliportDevice.............................................................................................................................9

Figure3IntelliportSensorwithlast4digitsoftheSerialNumber.............................................................17

Figure5EncodedSyringeAttachment........................................................................................................20

Figure7StandAloneMode........................................................................................................................21

Figure8AnesthesiaView............................................................................................................................22

Figure9UnitTotal.......................................................................................................................................23

Figure10NursingView...............................................................................................................................24

Figure11EMRIntegratedMode.................................................................................................................27

Figure12EMRIntegrated(CompanionView)............................................................................................28

Figure14Login............................................................................................................................................33

Figure15ConnectinganIntelliport............................................................................................................34

Figure16PatientSetup...............................................................................................................................35

Figure17ADTPatientList...........................................................................................................................35

Figure18ConfirmPatientAssociation........................................................................................................36

Figure19PatientAllergies..........................................................................................................................36

Figure20UserPreferences.........................................................................................................................39

Figure21ConnectingAdditionalIntelliports..............................................................................................40

Figure22SelectMedication.......................................................................................................................41

Figure23ModifySelectedMedication.......................................................................................................42

Figure24CocktailMedication....................................................................................................................43

Figure25AddInfusion................................................................................................................................44

Figure26ModifyInfusion...........................................................................................................................44

Figure27AddComment.............................................................................................................................45

Figure28MedicationOrders......................................................................................................................46

Figure30ReviewCase................................................................................................................................48

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Importantinformationishighlightedbytheseiconsandterms:

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WARNINGindicatesapotentialforpersonalinjuryordeath.

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CAUTIONindicateseitherpotentialdamagetothehardwareorlossofdataand

instructshowtoavoidtheproblem.

NOTENOTEindicatesimportantinformationtomakebetteruseoftheAnesthesiaSystem.

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SectionIBackground

Introduction

ThankyouforchoosingtheBDAnesthesiaSystem(AnesthesiaSystem).TheAnesthesiaSystemcanbe

usedwhenintravenousbolusinjectionsofmedicationaregiventoapatientbyanurseoranesthetistfor

automateddocumentationofmedication,concentration,dose,volumeandtimeofeachIVinjection

duringanoperation,recoveryandproceduralevent.

Duringtreatment,theclinicianconnectsanintelligentinjectionport,calledtheIntelliport™device,toa

patient'sfluid‐deliverylineandperformsstandarddrug‐deliveryactivities.TheIntelliportdevice

automaticallycapturesinformationaboutdrugsinjected,andwirelesslytransmitsthatinformationin

real‐timetotheTabletcomputer.TheTabletcomputerusesthatinformationandothermanually‐

enteredinformationtodisplayatime‐stampedmedicationrecord.Itprovidestheclinicianwithclinical

decisionsupport.Italsomakesthatinformationavailableforreportingandelectronicrecordkeeping

purposes.

TheAnesthesiaSystemhastwooperatingmodes.Thefirstconfigurationisastand‐alonesystemthat

supportsapaperanesthesiarecord.Thesecondconfigurationinvolvesintegrationwithelectronic

medicalrecordsorperioperativeinformationmanagementsystems(PIMS).

Thisguideprovidesinstructionsforthesafeandproperoperationofthedevice,aswellasset‐up,

configuration,andcareinformation.Readthisentiremanualcarefullyandfamiliarizeyourselfwiththe

featuresandoperationoftheAnesthesiaSystempriortouse.

ProductDescription

TherearefourcomponentstotheAnesthesiaSystem:

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Figure 1 Anesthesia System Components

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Tablet

computer

Intelliport

Device

Encoded

Syringes

Gateway

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Intelliportdeviceisanintelligentinjectionport.Itattachestoaninjectionsite(“YSite”orstopcock)for

manuallyadministeredIVinjections.ItiscomprisedofaSensorandaBase,whichsnaptogetherpriorto

use.TheIntelliportSensorisasteriledisposablehavinganinjectionportandaLuerconnection.The

IntelliportSensorissuppliedinasterilepackageforsinglepatientuse.TheIntelliportBaseisanon‐

sterile,reusabledevicethathousestheelectronicsandwirelesstransmitter.Itisbatterypowered,and

rechargeable.AseparateRechargerrechargesabatteryinthereusableIntelliportBasepriortoeach

use.

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Figure2IntelliportDevice

EncodedSyringesarecommercially‐availabledrugsinprefilledsyringeswithaspecialidentifier,called

“encoding”,thatstoresinformationaboutthemedicationcontainedwithinthesyringe.Encoded

syringesareready‐to‐use,passiveanddisposable.TheAnesthesiaSystemalsoaccommodatessyringes

nothavingencoding.

TabletComputerrunstheAnesthesiaSystemsoftware.Itcontinuouslycapturesanddisplaysthe

medicationadministrationrecord(MAR)datafromtheIntelliportdeviceeachtimeaninjectionoccurs.

Italsoenablesclinicianstomanuallydocumentotherpertinentclinicalinformation,anditprovides

clinicaldecisionsupporttohelpimprovesafetyandaidcliniciansduringtreatment.

GatewayissoftwarethatenablestheAnesthesiaSystemtofunctionasanenterprisedeviceand

informationsystem.TheGatewayprovidesacentralhubtowhichallTabletcomputersconnectviathe

hospitalnetwork.ItalsoincludesaninterfaceenginefortheAnesthesiaSystemtoexchangedatawith

othernetworkedhospitalinformationsystems,alongwithasuiteofutilitiesforgeneralGateway

implementation,operation,andmaintenance.

TheGatewayincludesabrowser‐baseduserinterfaceforadministratorsoftheAnesthesiaSystemto

configurethedevicelibraryandTabletcomputerdefaultsettings.



IntelliportBase

IntelliportSensor

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HowitWorks

ThemedicationadministrationprocessusingtheAnesthesiaSystemisillustratedinFigureXXX.Priorto

treatment,theclinicianprimesandconnectstheIntelliportdevicetothepatient’scatheterorinjection

port(y‐site).Duringmedicationadministration,theclinicianperformsstandarddrug‐deliveryofbolus

medications.

Whenasyringeisattachedtotheinjectionport,theIntelliportdeviceidentifiesthemedicationand

concentrationforanencodedsyringebyopticallyimaginganddecodingabarcodeonthetipofthe

syringe.ThisinformationiswirelesslytransmittedtotheTabletcomputer,andtheTabletcomputer

displaysandannouncesthedrugattached.Italsomayperformsafetychecks.

Asdrugispushed,theIntelliportdevicemeasuresthevolumedosedultrasonically.TheIntelliport

devicewirelesslysendsvolumemeasurementinformationtotheTabletcomputer.TheTabletcomputer

usesthisinformationtoprovideclinicianswithclinicalinformation.Themedicationadministration

informationistimestampedanddisplaysforclinicalreferenceduringsurgicalprocedures.Manually

enteredinfusionsandotherinformationpertainingtonon‐encodeddruginjectionsmaybeincludedin

thepatientmedicationrecord.

TheTabletcomputerwirelesslycommunicateswiththeGatewayonthehospitalnetwork,anditmay

sendmedicationadministrationtoHospitalInformationSystems,whenconfigured,forreportingand

electronicrecordkeepingpurposes.

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11

IndicationsforUse

TheAnesthesiaSystemprovidesarecordkeepingsystemwithpatientsafetyfeatures.

Electronicavailabilityofthepatient’sallergiesallowsforproactiveadversedrugeventscreeningwhen

thepatientisintheperioperativeenvironmentpriortoanyanesthesiadrugdelivery.

TheAnesthesiaSystemautomaticallydocumentsmedicationsinthepre‐op,intra‐op,andPACUareas

whenusinganencodedprefilledsyringe.Thecliniciancanenterdrugmedicationbymanuallyselecting

thedrugfromalistwhenusingasyringethatisnotencoded.Adruglibrary,managedbypharmacy,

containsdrugspecificinformationusedfordocumentingdrugsontheanesthesiarecord,performing

adversedrugeventchecks,andsubmittingmedicationutilizationinformationforbillingpurposes.

Availabilityofthepatient’sspecificdrugallergiesprovidesforpre‐screeningofthemedicationsthatare

connectedtotheIntelliportdeviceforinjectiontocheckforanypotentialadversedrugevents.Italso

providesamethodologyfornarcoticstrackingthroughitscomprehensivemedicationtrackingand

wastingfeature.

TheAnesthesiaSystemistobeusedinthehospitalperi‐operativeenvironments(inpatientand

outpatient)andspecialprocedurerooms.TheAnesthesiaSystemmayalsobeusedinnursingcareunits

forthetreatmentofpreandpostsurgicalpatientcare.Surgical/procedurepatientsshouldweigh

greaterthan35kgs,andhaveanintravenouslineestablished.Thesystemmayalsobeusedinnursing

careunitsforthetreatmentofpre‐andpost‐surgicalpatientcare.

ThecliniciansthatareintendedtousetheCRISIAnesthesiaSystemincludephysicianswithaspecialtyin

anesthesiology,CertifiedRegisteredNurseAnesthetistsandRegisteredNurses.Theseindividualsare

licensedtodelivermedicationsthroughapatient’svenousaccesspoint.(IFU026)

TheIntelliportSensormaybeusedupto72hours.Itisnotintendedtobereused.

TheIntelliportBaseisintendedforusewiththeIntelliportSensor.Itmaybereusedunlessithasa

exceededitsUsefulLife.Itshouldbedisinfectedandfullyre‐chargedbetweenpatientuses.

IntendedUse

TheAnesthesiaSystemisanautomatedrecordkeepingsystemforuseinperioperativeandprocedural

settings.Thesystemiscomprisedofainjectionportthatmeasuresadministrationofmedicationsto

patients,andadataprocessingmoduletoautomatetracking.Thesystemalsoincorporatespatient

safetyfeatures(alertsforpatientallergies)thatarealignedwithhospitalpatientrecordsandprotocols,

anditincludesamethodologyfornarcoticstrackingthroughacomprehensivemedicationtrackingand

wastingfeature.TheAnesthesiaSystemhasbothdisposableandreusableparts,andtheoverallsystem

isintendedforprescriptionuseonly.



TheIntelliportdeviceisintendedtobeusedonaY‐site,stop‐cockorIVmanifoldinjectionportofany

peripheralintravenousestablishedline.Thisincludesacentralvenouslineorperipherallyinserted

centralcatheter(PICC)line.Itisnotintendedtobeusedintheintra‐arterialorepidurallines.Venous

linescanbeestablishedinthesubclavian,femoral,intraosseousorvariousperipheralarmlocations.

TheIntelliportdevicemayrestorbesecuredtothepatient’sskinineitheroftheselocations.



12

SectionIISafetyPrecautions

TheinformationcontainedintheseInstructionsforUseisintendedtoassistinthesafeoperationofthe

AnesthesiaSystem.ThisproductistobeusedasspecifiedwithintheseInstructionsforUseandin

accordancewithfederalguidelines.

READALLINSTRUCTIONSBEFOREUSING.

SAVETHESEINSTRUCTIONS.

WarningsandPrecautions

General



DonotusetheAnesthesiaSystemnearMagneticResonanceImaging(MRI)equipment,

includingstereotaxistechnology.(IFU017)RemovetheIntelliportdevicefromtheIVY‐

sitepriortoimaging.



DonotusetheAnesthesiaSystemneartherapeuticradiationequipment,suchaslinear

accelerators.RemovetheIntelliportdevicefromtheIVY‐sitepriortoimaging.



Shockhazard:donotattempttoconnectordisconnecttheTabletcomputeror

IntelliportRechargerpowercordwithwethands.Makecertainthatyourhandsare

cleananddrybeforepressingthepowercord.



UseonlythepowercordsuppliedbythemanufacturerfortheTabletcomputeror

IntelliportRecharger.Neveradapttheplugtofitanonstandardoutlet.



Inspectthepowersupplycordfordamagepriortouse.ReplacetheTabletcomputer

powersupplyonlywiththeCRISIapprovedpowersupply.



Observerequirementsforpropergrounding.Thepowerreceptaclemustbeathree‐

wiregroundedoutlet.Ahospitalgradeoutletisrequired.Neveradaptthethreeprong

plugfromtheTabletcomputertofitatwo‐slotoutlet.Iftheoutlethasonlytwoslots,

makesurethatitisreplacedwithathree‐slotgroundedoutletbeforeattemptingto

operatetheTabletcomputer.Provideanisolatedpowersupplyforoperation.



Universalprecautionsshouldbeobservedtopreventcontactwithbloodorother

potentiallyinfectiousmaterials.Placecontaminatedmaterialsinaregulatedwaste

container.



Donotmixdisinfectingsolutions(e.g.,bleachandammonia)neartheAnesthesia

System,ashazardousgasesmayresult.



Useaccessoryequipmentrecommendedbythemanufacturer.Theuseofnon‐approved

accessoryequipmentwiththeAnesthesiaSystemisnotrecommended,andmayleadto

unsafeconditions.



Donotmodifyortamperwithsystemcomponentsforanyreason.Doingsowillvoidthe

manufacturerwarranty.Thesystemdoesnotincludeserviceablecomponents.Contact



13

yourAnesthesiaSystemrepresentativeforallrepairs.



Donotusedamagedequipment,frayedordamagedpowercords.(IFU023)



DonotexposetheAnesthesiaSystemtogasorheatsterilization.Autoclavingwill

seriouslydamagetheIntelliportBaseandTabletcomputer.



AvoidliquidingresstotheTabletcomputerorIntelliportBase.Fluidsmayinterferewith

theirperformance.



Operationofelectroconvulsivetherapy(ECT)equipmentduringuseoftheAnesthesia

SystemmaytemporarilyresultinsignallossbetweentheIntelliportdeviceandTablet

computer.

NOTEIfanypartoftheAnesthesiaSystem(Tabletcomputer,Intelliportdevice,Recharger)is

droppedorseverelydamaged,immediatelyremoveitfromuseandhaveitinspectedby

servicepersonnel.Ensureitsproperfunctionpriortoreuse.

Tabletcomputer



Thegroundleakagecurrentislessthanspecifiedlimitsestablishedforcommercial

Tabletcomputerpowersupplies.Asamatterofsafepractice,yourfacilityshould

conductperiodicteststoverifythesecurrents.ItisrecommendedthattheTablet

computerACpoweradapterbeconnectedtoanisolatedpowersupply.



Electricalshockhazard:DonotremovetheTabletcomputercover.ThereareNO

serviceablepartsinsidetheTabletcomputer.



Iftheintegrityoftheexternalprotectiveearthgroundisindoubt,theTabletcomputer

canbeoperatedfromitsinternalbatterypowersource.



SustainedcontactoftheTabletcomputerwithskincancausediscomfortorburns.Do

notallowtheTabletcomputertorestdirectlyonexposedskinforextendedperiods.

ThesurfacetemperatureoftheTabletcomputermayriseduringnormaloperation

particularlywhenoperatingunderACpower.



BesuretheTabletcomputerismountedsecurelyinplacetoavoidfallingandsustaining

injury.



Tocompletelyremovepowerfromtheunit,disconnectthepowercordfromthepower

receptacleoftheTabletcomputer.



ProperlysecuretheTabletcomputerpriortouseorafterpositioning.Donotloosely

placetheTabletcomputeronotherequipment.(IFU022)



DonotblockventilationinletholesontheundersideoftheTabletcomputer.



14



DonotopenormodifytheTabletcomputerforanyreason.Thereisasealtoprevent

liquidsfromentering,whichmaybedamagedifopened.

NOTETheTabletcomputercanonlybeusedwiththeAnesthesiaSystem.

NOTEBeforeeachuse,checkthevolumeofaudiblealertstoensuretheyarenotmuted.

Silencingthealertsmayadverselyaffectpatientsafety.

NOTEDonotpushanyobjectsintotheairventsorotheropeningontheTabletcomputer.

Doingsocancausefireorelectricshock.

NOTEDonotusepressurizedsprayswhencleaningtheTabletcomputerscreen.

NOTEDonotusehardorpointedobjectsontheTabletcomputerscreen.

Intelliportdevice



IntelliportdeviceshouldnotbeusedwithanArterialorepiduralline.Thismayresultin

seriousinjurytothepatient.VerifythelineplacementpriortoIntelliportY‐site

attachment.(IFU011)



DonotuseaneedleorbluntplastictipcannulawiththeIntelliportSensor.Thismay

resultinportvalvedamageresultinginfluidleaks,airintakeandbacterial

contamination.ReplacetheIntelliportSensorimmediately.



PrimetheintravenouslineandIntelliportSensorwithflushsolutionpriortobeginning

aninjection.TrappedairmayaffectIntelliportSensorperformanceandtheinjected

volumemeasurement.FailuretoprimetheIntelliportSensorcorrectlymaycausethe

volumeofinjectedmedicationtoreadlowerthantheactualtotaldeliveredtothe

patient.



CheckforanblockedfluidpathorleakingfittingswhenprimingtheIntelliportSensor.



SecuretheIntelliportdevicetothepatientpriortopatienttransporttoavoid

intravenouslinedisruption.(IFU021)

NotetheclarityoftheIVtubingandIntelliportSensorduringusetominimizebacteria

growth.ReplacetheIntelliportSensorifahighlipidmedicationhasbeeninjectedor

bloodisvisibleinsidethelumenoftheIntelliportSensororport.



DonotusetheIntelliportSensorwithanIVlineusingahighpressureinfusionflow

system.VerifythelineplacementpriortoIntelliportY‐siteattachment.





15



ThisdevicecomplieswithPart15oftheFCCRules.Operationissubjecttothefollowing

twoconditions:(1)Thisdevicemaynotcauseharmfulinterference,and(2)Thisdevice

mustacceptanyinterferencereceived,includinginterferencethatmaycauseundesired

operation.

ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforClassBDigital

Device,pursuanttoPart15oftheFCCRules.Theselimitsaredesignedtoprovide

reasonableprotectionagainstharmfulinterferenceinaresidentialinstallation.This

equipmentgeneratesandcanradiateradiofrequencyenergyand,ifnotinstalledand

usedinaccordancewiththeinstructions,maycauseharmfulinterferencetoradio

communications.However,thereisnoguaranteethatinterferencewillnotoccurina

particularinstallation.Ifthisequipmentdoescauseharmfulinterferencetoradioor

televisionreception,whichcanbedeterminedbyturningtheequipmentoffandon,the

userisencouragedtotrytocorrecttheinterferencebyoneormoreofthefollowing

measures.

•Reorientorrelocatethereceivingantenna

•Increasetheseparationbetweentheequipmentandreceiver

•Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhich

thereceiverisconnected

•Consultthedealeroranexperiencedradio/TVtechnicianforhelp

Anychangesormodificationsnotexpresslyapprovedbythepartyresponsiblefor

compliancecouldvoidtheuser’sauthoritytooperatetheequipment



Leschangementsoumodificationsnonapprouvésexpressémentparlapartie

responsabledelaconformitépourraitannulerl'autoritédel'utilisateuràfaire

fonctionnerl'équipement.



ThisdevicecomplieswithIndustryCanadalicence‐exemptRSSstandard(s).Operationis

subjecttothefollowingtwoconditions:(1)thisdevicemaynotcauseinterference,and

(2)thisdevicemustacceptanyinterference,includinginterferencethatmaycause

undesiredoperationofthedevice.



LeprésentappareilestconformeauxCNRd'IndustrieCanadaapplicablesauxappareils

radioexemptsdelicence.L'exploitationestautoriséeauxdeuxconditionssuivantes:(1)

l'appareilnedoitpasproduiredebrouillage,et(2)l'utilisateurdel'appareildoit

acceptertoutbrouillageradioélectriquesubi,mêmesilebrouillageestsusceptibled'en

compromettrelefonctionnement.)





16



DonotusetheIntelliportSensorwithanIVlineusingahighpressureinfusionflow

system.VerifythelineplacementpriortoIntelliportY‐siteattachment.





Verifytheencodinglabeliscleanandsecuretothesyringetippriortoattachingtothe

IntelliportSensor.



DisposeoftheIntelliportBaseitaccordingtoyourfacility’sprotocolforbatterydisposal

oflithiumionbatteries.



DiscardtheIntelliportSensorifitssterilepackagingisnotintactortheprotectorcapis

detached.



CliniciansmustbefamiliarwithandbetrainedintheuseoftheAnesthesiaSystem.Its

useshouldbeprecededbyanestablishedfacilityprotocol.



Swabtheinjectionportwith70%isopropylalcohol(ortheagentthatishospital

standard)andallowtodrypriortoeachsyringeinjectiontominimizethepotentialfor

crosscontamination.



ChangetheIntelliportSensoraccordingtofacilitypolicyforIVsetchangeorCDC(USA)

Guidelines;oriftheintegrityoftheIntelliportdevicehasbeencompromised.(IFU025)



TheAnesthesiaSystemisneitherdesignednorintendedtodetectnoralertifthereare

needleinfiltrations.Hospital/facilitypersonnelmustensuretheperformanceofthe

commonIVsite,priortoconductingbolusinjections.

NOTEVerifythattheIntelliportdeviceissecurelyluerlockedtotheY‐siteandtheIVtubingis

freefromkinksbeforeoperating.

NOTETheIntelliportSensordoesnothaveastopvalve(checkvalve);therefore,itis

recommendedtoclosetheupstreamflowontheIVlineduringinjectiontolimit

retrogradeflow.







17

SectionIIIDescriptionofAnesthesiaSystemComponents

TheAnesthesiaSystemisdesignedwithyourneeds,safetyandworkflowinmind.Thissectionwill

familiarizeyouwiththeAnesthesiaSystemcomponents,operationalmodes,displayviews,controls,and

indicators.

SuppliesandEquipment

TheAnesthesiaSystemisdesignedforusewiththefollowingequipment.

 IVvenouslinewithY‐siteneedlelessport(s),stopcockormanifold

 Intelliportdevice(sterilepackagedIntelliportSensorandchargedIntelliportBase)

 Medicationsyringes(havingencodingandwithoutencoding)

 Tabletcomputer

 Recharger

Intelliport

TheIntelliportdeviceisanintelligentinjectionport.Itattachestoaninjectionsite(“YSite”orstopcock)

formanuallyadministeredIVinjections.Itiscomprisedofasingle‐useIntelliportSensorandareusable

IntelliportBase,whichsnaptogetherpriortouse.UptothreeIntelliportdevicesmaybeinusewitha

patientatonetime.ThesemaybeattachedtotwoorthreeseparateIVlinesforthepatientorattached

viaamanifoldordifferentY‐sitesonthesameIVline.TheIntelliportdevicehasmemorythatwillstore

atime‐basedmedicationhistorylogfromthetimeofactivationtothetimewhenthedataissenttoa

Tabletcomputer.

IntelliportSensor

TheIntelliportSensorisasteriledisposablehavinganinjectionportandaLuer‐lockconnection.The

IntelliportSensorissuppliedinasterilepackageforsinglepatientuse.(IFU020)TheIntelliportSensor

hasamaleLuer‐lockconnectiononaone‐inchIVtubingpigtail.ThiscanbeattachedtoanIVlineataY‐

siteorIVmanifold.AnIntelliportSensorcannotbereusedwithadifferentpatient.EachIntelliport

Sensorhasauniqueserialnumber.Thelast4digitsoftheserialnumberareimprintedonthesurface

nexttoitsbarcode.ThisnumberisusedtoidentifyanIntelliportSensorwithinwirelessrangeusingthe

Tabletcomputer.



Figure3IntelliportSensorwithlast4digitsoftheSerialNumber

Last4digitsof

SerialNumber



18



Figure4IntelliportDeviceComponents

TheIntelliportSensorincludesaninjectionportandanIVconnectiontotheIVline.Theinjectionportis

acommonneedleless,Luer‐locktype.Itmaybecleanedpriortogivinganinjectionaccordingto

hospitalpolicy.PrimingwithanIVfluid(e.g.normalsalinesyringe,orpullbackfromIVline)isrequired

beforeuse.TheinjectionportontheIntelliportSensorsupportsupto100injections.



TheIntelliportSensorispackagedsterile,donotuseifpackageisdamagedorprotector

capisnotattached.



Donotuseaneedleorblunttipplasticcannula.Replaceimmediatelyifeitheris

inadvertentlyusedresultingindamagetotheIntelliportSensor(typicallyleaks).



PrimeIntelliportSensorbeforeuse.Attachaflushsyringetotheinjectionportand

purgeinfusionfluidtoremoveairfromtheIntelliportSensor.



ConfirmtheLuerlockissecurelyconnectedtoafullyprimedprimaryinfusionsetbefore

use.



DiscontinueuseoftheIntelliportSensorifthesyringeissecurelyattachedandyou

observeleaking(dropletsformingattheinjectionport)duringaninjection.

NOTEUseAsepticTechniquewhenhandlingtheIntelliportSensor.

IntelliportBase

TheIntelliportBaseisanon‐sterile,reusabledevicethathousesthebattery,electronicsandwireless

transmitter(calledaRadio).Itisbatterypowered,andrechargeable.Donotdiscardafteruse.An

IntelliportBaseisdesignedtobereusable.Itsupportsupto500re‐useswithdifferentpatients.Each

IntelliportBasehasauniqueserialnumberimprintedonitssurface.Thisnumberistransmittedtothe

Tabletcomputerduringuse.ThedistancebetweentheIntelliportdeviceandaTabletcomputershould

be10metersorlessinorderfortheIntelliportdevicetosendandreceivewirelesscommunications.

Therechargeablelithiumbatteryisnotremovable.TheentireIntelliportBaseconnectstothe

Recharger.Afully‐chargedIntelliportBaseissuitableforupto24hoursofuse,undertypicalconditions.



19

WhentheIntelliportBaseisconnectedtoaRecharger,upto4greenlightbarswillilluminate.The

numberofsolidgreenlightbarsindicatesthelevelofcharge.Theblinkinglightwillindicateitis

recharging.

upto25%charged

upto50%charged

upto75%charged

fullycharged

verylowbattery≤5%

WhentheIntelliportBaseisconnectedtoaRechargeraredlightindicatestheIntelliportBase

hasexceededitsUsefulLife.RefertoSectionXXCare&Maintenanceformoreinformation.

Status

TheIntelliportBaseisequippedwithstatusindicatorstoconveythefollowinginformation:

OperatingAdouble‐blinking,greenlightindicatestheIntelliportdeviceispoweredonand

notyetwirelesslyconnectedtoaTabletcomputer.

ErrorAredlightindicatesanerrorispresent.RefertoSectionXXTroubleshootingfor

moreinformation.

IdentifyGreen/yellowlightsflashfor3secondswhenanIntelliportdevicehasbeen

selectedattheTabletcomputer.

ClinicalAlertRed/green/yellowlightsflashfor3secondswhenapriorityclinicalalerthasbeen

triggered.ThisinformstheclinicianofanalertmessageontheTabletcomputer.

(e.g.aknownallergytoadruginaconnectedsyringe).(IFU010)

EndofUse AredlightinthelowestbatterychargepositionindicatestheIntelliportBasehas

beenusedwithmorethan500IntelliportSensors.

Recharger

AseparateRechargerrechargesthebatteryinthereusableIntelliportBasepriortoeachuse.Tousethe

Recharger,snapontotheIntelliportBase.

EncodedSyringes

TheAnesthesiaSystemsupportsinjectionsusinganyLuer‐locktypesyringe.Inaddition,thesystemhas

beendesignedtoworkwithencodedsyringesthathaveaspecialbarcodeidentifieronthesyringetip,

called“encoding”.Theencodingstoresinformationaboutthemedicationcontainedwithinthesyringe.



20

WhenanEncodedsyringesisattachedtotheinjectionport,thisinformationiswirelesslytransmittedby

theIntelliportdevicetotheTabletcomputer.



Figure5EncodedSyringeAttachment

Tabletcomputer

TheTabletcomputerisastandard,commercialTabletcomputerhavingAnesthesiaSystemsoftware,a

pressscreen,wirelesscommunications(Radio).Itistypicallymountedneartheclinician’sworkenvelop.

Itmayalsoberemovableforhand‐helduse.TheOn‐Offswitchislocatedatthetop,rightofthe

Tabletcomputer.ItincludesanACpoweradapter.Italsosupportsupto4hoursofbattery‐powered

use,undertypicaloperatingconditions.



Figure6TabletcomputerFeatureLayout



ReviewTabletcomputerWarningslistedonpagesXXpriortouse.

TheTabletcomputersupportsonepatientatatime.SolongasacaseisongoingattheTabletcomputer,

noothercasesorpatientscanbeaccessed.Inaddition,onlyoneclinicianmaybeloggedintoaTablet

computeratatime.

SoftwareRunninginStandaloneMode

Whenusedinahospitalhavingapaperanesthesiarecord,theTabletcomputersupportsfeaturesthat

assistwithdocumentingtheflowsheetportionandmayhelpwithdecisionsbytheclinician.Inthis

configuration,theTabletcomputercomplementsthepaperrecordkeepingactivitiesbytrackingand

Encoded

Syringe

On/OffSwitch

ACpoweradapter



21

displayinginjectionsgiventhroughtheIntelliportdevice.Italsoenablesclinicianstomanuallydocument

otherpertinentIVdruginjectionandinfusioninformation.

Thesoftwarescreensfollowathree‐stepapproachconsistingof1)connectingtheIntelliportdevice,2)

settingupthepatient,and3)viewingmedicationadministrationineithertheAnesthesiaViewor

NursingView.RefertoSectionsXXforinformationonconnectingtheTabletcomputertoanIntelliport

deviceandsettingupapatient.



Figure 7 Stand Alone Mode

ThefollowingsectiondescribesthebasicscreensontheTabletcomputer:

AnesthesiaView

TheAnesthesiaViewisaprimaryscreenforclinicianstointerfacewiththeAnesthesiaSystem.Thisview

providesinformationaboutthepatient,displaysdrugname/concentrationanddoseforacurrent

injectionaswellasahistoricallistofmedicationsthathavebeendeliveredtothepatient.Ifmayalso

includealistingofinfusionsgiventothepatient,ifrecordedbytheclinician.



22



Figure 8 Anesthesia View

InjectionBars‐Uptothreeinjectionbarsdisplayacrossthetopofthescreen,onecorrespondingto

eachwirelesslyconnectedIntelliport.Eachinjectionbarisarealtimerepresentationofthemedication

beingadministeredthroughanIntelliportdevice.WhenanencodedsyringeisattachedtoanIntelliport

device,theinjectionbardisplaysthedrugnameandconcentration.Whenanunencodedsyringeis

attached,theInjectionBarwillread“SelectMed”promptingthecliniciantoidentifythemedicationand

concentration.Asthemedicationisbeingdelivered,thevolumepushed(inmL)andthecorresponding

dosedisplaysinrealtimeintheinjectionbar.

MedicationHistory‐TheAnesthesiaViewincludesahistoricallistofmediationsthathavebeen

deliveredtothepatientorganizedbycarearea(medicationsgiveninthetransitiontimebetweencare

areas,willposttothenextcarearea)arrangedinaflowsheetformat.Thisincludesallmedicationsthat

wereadministeredtothepatientsincetheIntelliportdevicehasbeenactivatedwiththemorerecent

medicationadministrationsatthebottomofthelist.Ascrollbarisenabledwhenthelistexceedsthe

visiblespaceonthescreen.Whenanewmedicationisadded,themedicationlistwillscroll

automaticallysothenewmedicationnameisvisible.Handgesturingintheflowsheetwillscrollthe

flowsheettoviewhiddenmedicationadministrations.

NOTEForanesthesiamedications,acolortilecorrespondingtotheAmericanSocietyof

Anesthesiology(ASA)guidelinesdisplaysadjacenttothedrugname.(RefertoAppendix

Xformoreinformation).

Theflowsheettimescaleisadjustableanditcanshow1minute,5minute,and10minuteincrements.



23

"Dose"isshownonaflagbasedonthetimeinwhichitwasdelivered.Pressingtheflagforaspecific

medicationwilldisplaythe“ModifySelectedMedication”popup.Fromthispopup,themedication

administrationcanbeviewedandmodified.Acliniciancanmodifytheconcentration,dose.Thisscreen

isalsousedtospecifyacocktail(mixedmedication),adilutedorreconstitutedmedication.

Pressingthe“UnitTotal”numberforamedicationwilldisplayapop‐upscreenindicatingthemedication

andconcentration,totaldosegiven,numberofdosesgivenbycarearea,andtimeofeachdose.To

close,press“OK”onthebottomofthepop‐upscreen.



Figure 9 Unit Total

TheInfusionsectionislocatedabovethetimescale.Itdisplaysallcontinuousinfusionsrecordedbythe

clinician.Thosethatarecurrentlyactiveareshownwithabluebarandthosethatareinactivehavea

blackbar.Thisfeaturecanbehiddentoshowadditionalinjectionsbypressing“HideInfusions”from

theMenu.

TheCaseHeaderinformationliststhepatientname,dateofbirth,ageinyears,medicalrecordnumber

andpatientidentificationnumber.

TheMessageSectiondisplaysclinicalandsystemmessagesprioritizedbyimportanceandtime.The

Messageiconwillshowthenumberofunaddressedmessagesfortheclinician.Clinicalmessagesthat

havehigherimportance,suchasallergyalerts,willappearinthecenterofthedisplayscreen.(Figure

XX)

TheTitleBardisplaysacrossthetopofthescreen.Itincludesthenameoftheclinicianloggedin(ifso

configured)andthelocationassignedtotheTabletcomputer.ThefirsticontotherightoftheBar

indicatesifwirelesscommunicationbetweentheGatewayandtheTabletcomputerareactive.A

secondiconspecifieswhethertheTabletcomputerspeakersaremutedorunmuted.Thebattery

iconindicatestheremainingamountofchargeontheTabletcomputerandlastly,thehospitalnetwork

timeisshown.

NursingView

TheNursingViewisasecondscreenforclinicianstointeractwiththeAnesthesiaSystem.Likethe

AnesthesiaView,thisviewprovidesinformationaboutthepatient,displaysdrugname/concentration



24

anddoseforacurrentinjectionaswellasahistoricallistofmedicationsthathavebeendeliveredtothe

patient.Itmayalsoincludealistingofinfusionsgiventothepatient,ifrecordedbytheclinician.



Figure 10 Nursing View

TheNursingViewhasmanyofthefeaturesintheAnesthesiaView;howeveritisarrangedinatabular

format.Thetableheadingsinthisviewincludemedicationwithconcentration,timeadministered,dose,

andunittotal.Themedicationsaredisplayedinreversechronologicalorderwithmostrecent

medicationadministeredatthetopofthelist.Ascrollbarisenabledwhenthelistexceedsthevisible

spaceonthescreen.Handgesturinginthetablewillscrolltoviewhiddenmedicationadministrations.

Theblackhorizontalbarsidentifythecareareainwhichthemedicationsweregiventothepatient,or

whentransitioningfromonecareareatoanother.

ButtonandMenuOptions

Thefollowingfeaturesareavailablefromthefourbuttonslocatedinthelowerrightcornerofthescreen

(Allergies,Comments,Add,Menu):

AddInfusionSelectthisoptiontorecorddetailsaboutaninfusion.

RefertoSectionXformoreinformation.

AddInjectionSelectthisoptiontorecorddetailsaboutaninjection

givenpriortoactivatinganIntelliportdeviceorgiven

throughaportotherthantheIntelliportdevice.Referto

SectionXformoreinformation.

AddCommentSelectthisoptiontorecordgeneralcomments.(thereare

additionalwaystopairacommentwithanallergyordrug



25

injection).RefertoSectionXformoreinformation.

Allergies Selectthisoptiontoviewthelistofallergies,including

severityandtypeofreaction.



PauseCasePressthisbuttonwhentransferringapatienttoanother

carearea.Indoingso,itdisconnectsallconnected

Intelliportdevicesinpreparationfortransfer.Referto

SectionXformoreinformation.



CloseCasePressthisbuttonwhenthecaseiscompleteandthe

patientisbeingpreparedfortransferoutofthe

perioperativearea.Indoingso,itpowersdownall

connectedIntelliportdevices.RefertoSectionXformore

information.

NOTE:Pressingthisbuttonwillclosethecaserecordon

theAnesthesiaSystem.Thecasewillnolongerbe

availabletothenextcarearea.



SwitchUserSelectthisoptiontochangetheclinicianloggedin,ifso

configured.RefertoSectionXformoreinformation.



Show/HideInfusionsPressthisbuttontotogglebetweendisplayingorhiding

infusionsontheAnesthesiaViewflowsheet.Referto

SectionXformoreinformation.



ChangeTimeScalePressthisbuttontotogglebetween1minute,5minute

and10minutetimeintervalsontheAnesthesiaView

flowsheet.



Sound/MutePressthisbuttontotogglebetweenaudible

announcementsandmute.RefertoSectionXformore

information.



PreferencesSelectthisoptiontoviewandmodifypreferencesfor

announcements,volumeandscreenbrightness.Referto

SectionXformoreinformation.



ReportsSelectthisoptiontoviewandprinttheControlled

Substance,Handoff,andMedicationAdministration

reports.RefertoSectionXformoreinformation.



HandoffViewPressthisbuttontoviewtheHandoffscreen.Referto

SectionXformoreinformation.



NursingViewPressthisbuttontoviewtheNursingViewscreen.Refer

toSectionXformoreinformation.



26



AnesthesiaViewPressthisbuttontoviewtheAnesthesiaViewscreen.

RefertoSectionXformoreinformation.



HelpSelectthisoptionwhenseekingassistanceinoperation.It

provideshelpfulinformation,includingtheDirectionsfor

Use.(IFU028)



ShutDownPressthisbuttontopowerofftheTabletcomputer.Refer

toSectionXformoreinformation.





27

SoftwareRunninginEMR‐IntegratedMode

Whenusedinahospitalhavingelectronicmedicalrecords(EMR)intheperioperativecareareas,the

TabletcomputerservesasacompaniontotheEMRsystemorperioperativeinformationmanagement

system(calledaPIMS).Inthisconfiguration,theTabletcomputerprovidesareal‐timedisplaywhilethe

drugisbeinginjected,thenitsendstheinjectionsdatainrealtimetotheEMR.Theclinicianrefersto

theEMRforahistoryofmedicationsgiven‐‐unlikethepaperanesthesiarecordconfiguration.

Thesoftwarescreensfollowathree‐stepapproachconsistingof1)connectingtheIntelliportdevice,2)

verifyingthepatientinformationreceivedfromtheEMR,and3)givinginjections.RefertoSectionsXX

forinformationonconnectingtheTabletcomputertoanIntelliportdeviceandsettingupapatient.



Figure 11 EMR Integrated Mode

TheCompanionViewhasaprimaryscreenforclinicianstointerfacewiththeAnesthesiaSystem.This

Viewprovidesinformationaboutthepatient,displaysdrugname/concentrationanddoseforthe

currentinjectionandrelevantclinicalandsystemmessages.



28



Figure 12 EMR Integrated (Companion View)

TheCompanionViewconsistsofthefollowingscreenfeatures:1)ActiveInjectionBar;2)TitleBarwith

cliniciannameandlocationofdisplayTabletcomputer;3)CaseHeaderinformationonpatientname,

MRN,Patientidentificationnumber;4)Allergies;5)ClinicalorSystemMessages.

InjectionBars‐Uptothreeinjectionbarsdisplayonthescreen,onecorrespondingtoeachwirelessly

connectedIntelliportdevice.Eachinjectionbarisarealtimerepresentationofthemedicationbeing

administeredthroughanIntelliportdevice.WhenanencodedsyringeisattachedtoanIntelliport

device,theinjectionbardisplaysthedrugnameandconcentration.Whenanunencodedsyringeis

attached,theInjectionBarwillread“SelectMed”promptingthecliniciantoidentifythemedicationand

concentration.Asthemedicationisbeingdelivered,thevolumepushed(inmL)andthecorresponding

dosedisplaysinrealtimeintheinjectionbar.Uponcompletionofthesyringepush,themedication

administrationwillpassimmediatelytotheEMRwithaconfirmationmessageconfirmingsuchinthe

messagearea.

NOTEForanesthesiamedications,acolortilecorrespondingtotheAmericanSocietyof

Anesthesiology(ASA)guidelinesdisplaysadjacenttothedrugname.(RefertoAppendix

Xformoreinformation).

TheCaseHeaderinformationliststhepatientname,dateofbirth,ageinyears,medicalrecordnumber

andpatientidentificationnumber.

TheMessageSectiondisplaysclinicalandsystemmessagesprioritizedbyimportanceandtime.The

Messageiconwillshowthenumberofunaddressedmessagesfortheclinician.Clinicalmessagesthat

havehigherimportance,suchasallergyalerts,willappearinthecenterofthedisplayscreen.(Figure

XX)

TheTitleBardisplaysacrossthetopofthescreen.Itincludesthenameoftheclinicianloggedin(ifso

configured)andthelocationassignedtotheTabletcomputer.ThefirsticontotherightoftheBar

indicatesifwirelesscommunicationbetweentheGatewayandtheTabletcomputerareactive.A



29

secondiconspecifieswhethertheTabletcomputerspeakersaremutedorunmuted.Thebattery

iconindicatestheremainingamountofchargeontheTabletcomputerandlastly,thehospitalnetwork

timeisshown.





30

SectionIVOperations

TheAnesthesiaSystemisdesignedwithyourneeds,safetyandworkflowinmind.Thischapterwill

acquaintyouwiththeAnesthesiaSystemoperationalmodes,displayviews,controls,andindicators.It

alsoprovidesgeneralinformationonuseofthedevice.

QuickGuide

PreparetheIntelliport

TheIntelliportdevicemustbeprimed,attachedtoanIVlineandassembledinpreparationforuse.

1. GatheranIntelliportSensorinitssterilepackagingandafully‐chargedanddisinfectedIntelliport

Base.

2. PrimebyflushingwithsterileIVfluidbeforeattachingtotheY‐siteORbyaspiratingIVsolution

throughasyringeattachedtotheport.

3. AttachtheIntelliportSensortotheIntelliportBasebyjoiningtheIntelliportSensor(tubingside)

andIntelliportBasefrontsectionsfirst,thensnapthetwotogether.Oneshouldaudiblyhear

the“snap”.

4. VerifyproperseatingofIntelliportSensortotheIntelliportBasebycheckingforablinkinggreen

lightontheIntelliportdevice.Ifthisisnotseen,viewtheIntelliportdeviceonitssideto

determineifthetwoareproperlyconnected.IfaspaceisseenbetweentheIntelliportSensor

andIntelliportBase,thenseparateandre‐attachproperly.

5. TheIntelliportdeviceisnowreadyfordeliveryofIVmedications.Anymedicationsgiventhrough

theIntelliportdevicewillbesavedtotheIntelliportmemory.

SetuptheTabletcomputer

TheTabletcomputermustbesetuptowirelesslycommunicatewiththeIntelliportdeviceandtobe

associatedwithapatientrecord.AnyMedicationsgivenpriortoassociationtoaTabletcomputerwill

beheldintheIntelliportmemory.ThreeIntelliportdevicescanbesynchronizedtoonepatient.

6. PowerontheTabletcomputerbypressingandholdingthebuttonlocatedontopofTablet

computer.

7. Thefirstscreensupportslog‐in,ifsoconfigured.EnterUsernameandPassword

8. Identifythe4digitnumberontheIntelliportSensor.

9. FromtheIntelliportSetupscreen,select(highlight)theIntelliportdevicecorrespondingtothe

fourdigitsnumberontheIntelliportSensor.

10. VerifythecorrectIntelliportdevicehasbeenselectedbycheckingthatthegreenandyellow

lightsareblinking.

11. IftheidentifiedIntelliportdeviceiscorrect,press“Connect”.

12. VerifytheIntelliportdeviceflashesasingle,repeatinggreenlightwhenitiswirelesslyconnected

totheTabletcomputer.

13. Identifythepatient’sfullname,patientID,medicalrecordnumberandbirthdate.

14. FromthePatientSetupscreen,selectthepatientfromthelist.Press“Emergency”tobegina



31

casewherepatientdemographicsarenotavailable.

NOTEAfterstartingacaseusingtheEmergencybutton,thepatientcanbeidentifiedatany

timepriortoclosingthecase.

15. “Confirm”thecorrectIntelliportdeviceandpatienttocompletethesetup.Onceconfirmed,

theAnesthesiaSystemhasestablishedapermanentassociationbetweenthepatientand

IntelliportSensor.

GiveIVinjectionsandViewMedicationAdministrations

16. CleantheIntelliportSensorinjectionportbyswabbingthehubaccordingtoyourhospital

protocol.

17. AttachasyringetotheIntelliportSensorinjectionport.

18. VerifythedrugdisplayedandannouncedbytheTabletcomputeristheintendeddrugand

concentration.Whenusingasyringewithoutencoding,“SelectMed”willannounceanddisplay

alistofmedicationstoidentify.(Press“More”ifyoudonotseethemedicationname).

a. Identifythemedicationbeforeorafterdosedelivery.Confirmmedicationandpress

“Save”.

b. Frequentlydilutedorreconstituteddrugsshalldisplaynodosevalueuntiltheclinician

identifiesthegivendoseonthe“ModifySelectedMedication”screen.Theidentified

dosewillappearontheflag.

c. Cocktail(mixingtwomedicationsinonesyringe)canbeidentifiedbypressingthe

“Cocktail”buttonfromthe“SelectMed”screen.



UseclinicaljudgmentbeforeproceedingwhentheTabletcomputerannouncesand

displaysaknownallergyforthedrugattachedtotheIntelliportdevice,ifsoconfigured.

19. ThevolumeanddosewilldisplayontheTabletcomputerwhenthesyringeisremovedoratend

oftheinjection,ifthesyringeisleftattachedtotheIntelliportdevice.





32

DetailedOperatingInstructions

PreparetheIntelliport

TheIntelliportdevicemustbeprimed,attachedtoanIVlineandassembledinpreparationforuse.

1. GatheranIntelliportSensorinitssterilepackagingandafully‐chargedanddisinfectedIntelliport

Base.



NOTEAfully‐chargedIntelliportBasehassufficientpowerfor24hoursofuseundertypical

conditions.InspecttheIntelliportBasechargelevel.ReplaceanIntelliportBasewith

lessthan25%charge.Thiscanbedoneatanytimesolongasaninjectionisnotbeing

given.



VerifytheIntelliportBasehasbeencleanedanddisinfectedbeforeuse.



VerifytheIntelliportSensorsterilepackageisintactandthetubingendcapisstillin

place.

2. PrimebyflushingwithsterileIVfluidbeforeattachingtotheY‐siteOR,byaspiratingsolution

fromtheIVlinethroughasyringeattachedtotheport.(IFU01)

NOTEAfterpriming,visuallyinspectforleaksorblockagetotheIVline.

3. AttachtheIntelliportSensortotheIntelliportBasebyjoiningtheIntelliportSensor(tubingside)

andIntelliportBasefrontsectionsfirst,thensnapthetwotogether.Oneshouldaudiblyhear

the“snap”.ConnectingIntelliportSensortoIntelliportBasewillautomaticallypoweronthe

Intelliportdevice.

NOTETheconnectionofIntelliportSensortotheIntelliportBaseisverifiedbyablinkinggreen

lightontheIntelliportdevice.Ifthisisnotseen,viewtheIntelliportdeviceonitssideto

determineifthetwoareproperlyconnected.IfaspaceisseenbetweentheIntelliport

SensorandIntelliportBase,thentheyarenotattachedproperly.Separatethetwo

piecesandre‐attach.

4. Whereappropriate,securetheIntelliportdevicetoasurfaceinpreparationforgivinginjections.

AvoidkinksinthelinebetweentheIntelliportdeviceandIVline.



SecureanIntelliportdevicepriortopatienttransport.

5. TheIntelliportdeviceisnowreadyfordeliveryofIVmedications.Anymedicationsgiventhrough

theIntelliportdevicewillberecordedintheIntelliportmemory.

IntheeventofaSystemorIntelliportfailure,(excludingthefluidpathway),theIntelliportdevicewill

allowstandardmedicationorfluiddelivery.

SetuptheTabletcomputer–PaperAnesthesiaRecord

TheTabletcomputermustbesetuptowirelesslycommunicatewiththeIntelliportdeviceandtobe

associatedwithapatient.



33

6. TurnontheTabletcomputerbypressingandholdingthepowerswitchontopofTablet

computer.

NOTETheTabletcomputercanoperatefor4hoursonbatterypower(notpluggedintoa

powersupply)undertypicalconditions.VerifytheTabletcomputerispluggedinpriorto

usebycheckingthepowerindicatorontheTitlebarontheTabletcomputerscreen.

NOTEOnstartup,theinitialscreenwilldisplayinformationaboutthesoftware,druglibrary

andconfigurationversions–aswellasinformationonnetworkconnectivity.Contact

yourSystemAdministrationifsoinstructed.

7. TheLoginscreenwilldisplayiftheAnesthesiaSystemisconfiguredforuserlogin.TypetheUser

NameandPassword,thenpressthe“Login”button.



Figure 13 Login

NOTETheTabletcomputerwilllocktheuseroutafterseveralunsuccessfulloginattempts.

FollowthescreendirectionsforcontactingtheSystemAdministrator.(IFU029)

8. Identifythe4digitnumberontheIntelliportSensor.



Figure14Login

9. AlistofIntelliportdeviceswithinwirelessrangeareviewableontheIntelliportSetupscreen.

Select(highlight)yourIntelliportdevicebytimeofinitialactivationandlastfourdigitsofthe

serialnumberontheIntelliportSensor.

Lastfourdigitsof

serialnumber



34



Figure 15 Connecting an Intelliport

NOTEAlowbatteryiconwilldisplayforalistedIntelliportwhenlessthan25%ofbattery

chargeremains(approximately4hoursundertypicalconditions).Considerreplacing

withafully‐chargedIntelliportBasebeforeconnecting.

10. SelecttheIntelliportdeviceforyourpatientbypressingandhighlightingtheappropriate

Intelliportserialnumber.

11. VerifythatthegreenandyellowlightsareflashingforthecorrectIntelliportdevice.

NOTEShouldyoumissthevisualconfirmation,highlighttheappropriateIntelliportdevice

againtoinitiatetheblinkinglights.

12. Thescreenwillhighlightyourconnection.

13. TheIntelliportdevicewillilluminateasingle,repeatinggreenlightwhenitiswirelessly

connectedtotheTabletcomputer.

14. Identifythepatient’sfullname,patientID,medicalrecordnumberandbirthdatefromthe

patientandwristband.

15. FromthePatientSetupscreen,selectthepatientfromthelist.



35



Figure 16 Patient Setup

Ifthepatientisnotlisted,pressthe“MorePatients”buttontofindthepatientontheADTlistby

filteringthislongerlistbythepatientname,patientIDorMRN.Akeyboardwillappeartotype

thefirstlettersoftheLastName.



Figure 17 ADT Patient List

NOTEThereisan“Emergency”buttonontheTabletcomputerscreenforpatientswhose

nameisnotknownorthecliniciandeterminesanemergentsituationtostart

medicationtreatment.

16. Pressthe“Confirm”buttontocompletethesetup.(IFU027)Shouldanypartoftheassociation

beincorrect,thereisanopportunitytopressthe“Remove”buttonandrepeatthepatient

identificationstepprocess.(Figure18)Onceconfirmed,theAnesthesiaSystemhasestablisheda

permanentassociationbetweenthepatientandIntelliportSensor.TheIntelliportSensorcan

onlybepairedwithonepatient.



36



Figure 18 Confirm Patient Association

NOTEIfthewrongpatientwasinadvertentlyconfirmedtotheIntelliportdevice,thereisa

“RemoveIntelliport”buttonontheMainMenubuttonthatwilldisassociatethepatient

fromtheIntelliportdeviceandundoanymedicationadministrationhistory.

ShouldtheIntelliportBasebecomedisconnectedfromtheIntelliportSensorduring

operation,reattachandverifypatientassociation.

17. FollowingPatientSetup,theTabletcomputerdisplaysallergiesfortheselectedpatient,ifso

configured.Knownallergies,withseverityandtypeofreactionwilldisplay(FigureXX).



Figure 19 Patient Allergies



37

NOTEIfthepatientallergiesarenotavailablefortheTabletcomputer,theclinicianwillseea

message“UnabletoObtain”.

NOTETheTabletcomputerchecksforupdatestopatientallergyinformationduringacase.

18. ThereisanopportunitytotypeacommentforanallergybyselectingtheAllergyandpressing

theCommentbutton.Akeyboardwilldisplaytotypeacomment.(Figurexx)

19. Oncethecommentisrecorded,pressthe“OK”buttontosave.ThiswillreturntotheAllergylist.

GiveanIVinjectionUsingtheIntelliportDevice

20. Cleantheinjectionportbyswabbingthehubaccordingtoyourhospitalprocedure.(IFU013)

21. AttachasyringetotheIntelliportinjectionport.



Doublecheckeachmedicationnameandconcentrationonthesyringepriorto

attachmenttotheinjectionporttoassure“rightmedication.”(IFU02)

1. VerifythedrugdisplayedandannouncedbytheTabletcomputeristheintendeddrugand

concentration.(IFU019)Forsyringesnothavingencoding,refertoSection:SpecialActivities;

MedicationDeliverywhenSyringesNotEncoded,thenreturntothisstep.(IFU04)

2. TheIntelliportdevicewillflashred,greenandyellowlightsifamedicationallergyisdetected,if

soconfigured.



UseclinicaljudgmentbeforeproceedingwhentheTabletcomputerannouncesand

displaysaknownallergyforthedrugattachedtotheIntelliportdevice.Allergy

messageswilldisplayasbelow:



3. ThereisnocheckvalveintheIntelliportSensor,socloseorpinchtheupstreamIVtubingoruse

acheckvalveIVsettopreventmedicationtravelingtowardstheIVbagduringinjection.(IFU

009)

NOTEAlternativestopreventretrogradeflowinclude:1)attachingathree‐waystopcockonto

theY‐siteandluerlockingtheIntelliportSensorontothestopcock;2)attachinga

manifoldtotheIVorextensiontubingandluerlocktheSensordirectlytothemanifold.

4. Whendeliveringmedications,observethegraduationsonthesyringetochecktheamountof

drugdelivered.(IFU003)VerifydoseshownintheactiveinjectionbaroftheTabletcomputer.

(IFU007)TheIntelliportdevicemeasures0.4mLto55mLperinjection.(IFU008)



38

NOTEIftheinjectionflowrateisveryslow,amessagewilldisplayontheTabletcomputer.

(IFU031)Iftheamountofinjectedmedicationisnotmeasurable,theactiveinjection

barwillindicate“dashes”forvolumeanddose.Amessagewillinstructtheclinicianto

enterthedosemanuallythroughthe“ModifySelectedMedication”screen.Once

completed,thedosewilldisplay.RefertoSectionXXXformoreinformation.

NOTEPushingmedicationfroma50mLsyringerapidlyhasthepotentialtocausecollapseof

theIVline.Pushslowertoaccommodatedeliveryofalargeamountofmedication.

5. FollowallinjectionsthroughtheIntelliportdevicewithanencodedNormalSalineflushto

ensurethefulldoseofmedicationsreachesthepatient,especiallywhensuccessivelydelivering

twoincompatiblemedications.(IFU06)

NOTENormalSalinewillappearontheactiveinjectionbarwiththeamountofmLdelivered.

Normalsalinemaynotdisplayonthemedicationhistory,ifsoconfigured.

6. MakeadjustmentstothemedicationadministrationrecordontheTabletcomputerfor

injectionsinvolvingadiluteddrug,reconstituteddrug,ormixeddrugs,ifsoconfigured.

InjectionsarerecordedwhetherornottheIntelliportdeviceiswirelesslyconnectedtotheTablet

computer.TheIntelliportBasestoresinjectioninformationinitsmemoryandtransmitsthisinformation

uponwirelessconnectiontotheTabletcomputer.(IFU030)





39

SpecialActivities

SettingUserPreferences

TheAnesthesiaSystemsupportsuserpreferencestodeterminethesoundvolume,screenbrightness

andaudibleannouncements,remindersandmessages.(IFU016)Thehospitalhasconfigureddefault

preferencesthatmaybemodifiedtemporarilyduringacase.ToverifytheTabletcomputerpreferences

priortostartingacase,performthefollowing:

1. SelectPreferencesfromtheMenu.

2. Adjustpreferencefortheworkenvironment.

3. Press“Save”buttonwhencompleted.



Checkwhetheralertshavebeenmutedwhenrelievingaclinicianduringacase.

Preferencechangesareretainedduringthecase.Whenthecasehasclosedorwhenanewclinicaluser

logsin,thesettingsreverttothedefaultconfiguration.



Figure 20 User Preferences



Selectingthe“Mute”optionfromtheMenuwilloverridealloftheaboveselectionsand

mutealldrugannouncements,clinicalremindersandsystemmessages.Tohearthe

medicationannouncements,select“Unmute”.

AddingAdditionalIntelliports

TheAnesthesiaSystemcanaccommodateupto3Intelliportdevicesconnectedtoonepatientatatime.

AnadditionalIntelliportdevicecanbeaddedatanytimeduringacase.ThefirstconnectedIntelliport

devicewilldisplayintheleftmostinjectionbar.Thesecondinthemiddle,andthethirdtherightmost

injectionbar.RefertoFigure6.

NOTEWhenanIntelliportisconnectedtoaTabletcomputerandthereisnosyringeattached

totheIntelliportdevice,theactiveinjectionbarshallread“IntelliportConnected,No

syringeattached”.Abatterystatusiconwillindicatebatterychargelevelinthecorner

oftheinjectionbar.



40

ToaddanIntelliportdevice:

1. PrepareanIntelliportdeviceaccordingtotheinstructionsinSectionX.

2. Press“TaptoConnect”onanyoftheremainingActiveInjectionBarspacestodisplayapop‐up

windowthatlistsavailableIntelliportdeviceswithinwirelessrange.

3. Identifythe4digitnumberontheIntelliportSensor.

4. Select(highlight)yourIntelliportdevicebasedonthetimeofinitialactivationandthefourdigit

numberontheIntelliportSensor.



Figure 21 Connecting Additional Intelliports

NOTEAlowbatteryiconwilldisplaywhentheselectedIntelliportdevicehaslessthan10%of

batterypowerremaining.

5. TheselectedIntelliportdevicewillflashlightsfor3seconds.

6. VerifythegreenandyellowlightsareflashingforthecorrectIntelliportdevice.

NOTEShouldyoumissthevisualconfirmation,highlighttheappropriateIntelliportdevice

againtoinitiatetheflashinglights.

7. IftheidentifiedIntelliportdeviceiscorrect,press“Connect”.

8. VerifytheIntelliportdeviceisflashingasingle,repeatinggreenblinkinglightindicatingitis

wirelesslyconnectedtotheTabletcomputer.

9. PressConfirm.AnActiveInjectionBarwilldisplaytheconnectedIntelliportdevice.

MedicationDeliverywithSyringesNotEncoded

TheAnesthesiaSystemisdesignedtoworkwithbothencodedsyringes(thosehavingaspecialbarcode

identifieronthesyringetip)andunencodedsyringes.Whenanunencodedsyringeisattachedtothe

Intelliportdevice,theTabletcomputerwilldisplaythe“SelectMedication”pop‐uphavinga

perioperativemedicationlist.(IFU018)Acliniciancanidentifythemedicationinthesyringebefore



41

givingtheinjection(recommended)orafterwards.Ifpostponed,theTabletcomputertracksinjections

notyetidentifiedandlaterpromptsthecliniciantoresolve.

1. SelectthemedicationandconcentrationfromtheFrequentUselistbyhighlightingthename.

Thislistincludesmedicationspreviouslyidentifiedduringthecaseasgivenbyanunencoded

syringe.



Figure 22 Select Medication

2. IfthedesiredmedicationisnotfoundontheFrequentUselist,press“More”toviewalonger

listofperioperativemedications.

3. Filterthelistbypressingthefirstlettersofthedrugnameusingthekeypad.

4. Highlightthedesiredmedicationandconcentration,verifytheinformationandpress

“Save”.(IFU05)

SpecifyingaDilutedorReconstitutedMedication

TheTabletcomputerprovidesasimpleapproachtodocumentmedicationsthatrequiredilutionor

reconstitutionfromapowderformpriortopreparationforinjection.Ittracksfrequentlydilutedand

reconstitutedmedications.TheTabletcomputerpromptsthecliniciantoconfirmwhetheradrughas

beendilutedorreconstituted.Ifnot,nouseractionisrequired.

NOTEReconstituteddrugsdonotdisplayadosevalueuntiltheclinicianmodifiesthe

medication.

5. Tospecifyadilutionorreconstitution,press“Modify”onthe“SelectMedication”popup.Or

pressonthedoseflag(AnesthesiaViewflowsheet)ordoserow(Nursingview)andpress

Modify.

6. ChangethemedicationconcentrationordosebypressingtheConcentrationbox,thenenterthe



42

concentrationvalueusingthenumericalkeypad.

7. Reviewthenumbersentered,thenpress“Save”buttontorecordthenewvalue.(IFU017)This

changewillbereflectedinthemedicationadministrationhistory.



Figure 23 Modify Selected Medication

SpecifyingaMixedMedication(Cocktail)

Addingtwomedicationsintoonesyringeiscalledamixedmedicationorcocktail.Dependingonyour

institution,mixedmedicationsmayincludethefollowing:

 Propofol/lidocaine

 Propofol/fentanyl

 Propofol/ketamine

 Neostigminemethylsulfate/glycopyrrolate

 Atropine/edrophonium

 Narcan/edrophonium

TheTabletcomputerprovidesasimpleapproachtodocumentmixedmedications.Ittracksfrequently

mixedmedications,anditpromptsthecliniciantoconfirmwhetheradrughasbeenmixed.Ifnot,no

useractionisrequired.

1. Tospecifyamixedmedication,press“Cocktail”onthe“SelectMedication”popup.Orpresson

thedoseflag(AnesthesiaViewflowsheet)ordoserow(Nursingview)andpress“Cocktail.”

2. The“ModifySelectedMedication”popup(Figure24)displaystwomedicationnames;withthe

firstonealreadyidentified.

3. SelectthesecondMedicationfromthelist.Iftheintendedmedicationisnotlisted,press

“More”andtheclinicianmayidentifythecorrectmedicationfromthe“FrequentUse”or

perioperativedruglibrarylist.



43



Figure 24 Cocktail Medication

4. Enterthevolumeinjectedforeitherdrug.TheTabletcomputerwillcalculatethevolumeforthe

othermedicationusingthetotalvolumeinjected.

5. Press“Save”.

AddingManualInjection(forPaperAnesthesiaRecords)

TheTabletcomputerprovidesthemeanstodocumentIVinjectionsgivenpriortoactivatingan

IntelliportdeviceorgiventhroughanIVportotherthantheIntelliportdevice.(ICU016)

1. Pressthe“Add”button,thenpress“AddInjection”.TheFrequentUsemedicationlistwill

display.

2. Highlightthedesiredmedicationandconcentration.Indicatethevolumeordose.

3. Changethetimebypressingontheappropriatearrowstothecorrecttimeofadministration.

4. Press“Save”andthemedicationwilllistinthemedicationhistoryareaattheindicatedtime.

NOTEAmedicationadministrationtimecannotbeinthefuturenormorethanonehour

beforethefirstIntelliportdevicehasbeenactivated.

AddingInfusions(forPaperAnesthesiaRecords)

TheTabletcomputerprovidesthemeanstodocumentinfusions.

1. PresstheAddbutton,thenpress“AddInfusion.”

2. TheInfusionmedicationlistwilldisplayhavingfourcategories:Fluids,Medications,Titratable

Medications,andBloodProducts.Selecttheappropriatecategory.



44



Figure 25 Add Infusion

3. Selecttheappropriateinfusion,bagsizeandconcentration.Press”Save”.

4. Specifyatimepoint.Tochangethetime,pressthearrowsofthehourandminutesupto

increaseanddowntodecrease.



Figure 26 Modify Infusion

NOTEAmedicationadministrationtimeforaninfusioncannotbeinthefuturenormorethan

onehourbeforethefirstIntelliportdevicewasactivated.

5. Specifytheamountinfusedasofthattime(Optional).

6. Press“Save”.

Acliniciancanaddthevolumeinfusedforacareareaatanypointduringacasebypressingonthe

infusionbar,enteringvolumeinfusedandpress“SAVE”.Tostopaninfusion,pressthe“Stop”button

andpress“Save”.Inactiveinfusionswilldisplayablackbarandthetimetheinfusionwasstopped.



45

AddingaComment(forPaperAnesthesiaRecords)

Acommentisafreetextentrythatisrelevanttotheanesthesiarecord.TheTabletcomputersupports

fourmethodstoaddtoacomment:

 Allergies–commentsforaspecificdrugallergy.Tomakeacommentontheallergypop‐up

screen,highlighttheallergymedication,thenpress“Comment”button.Thiswillautomatically

displayakeyboardalongwithstandardcommentoptions.Thecliniciancanpressoneofthe

standardoptionsortypeacommentandpress“Save”.Therecordedcommentisdisplayedwith

eachallergypop‐up.(Theallergypop‐upscreenisdisplayedonPatientSetuporbypressingthe

“Allergies”buttoninthelowerrightcorner.)

 Time–commentstiedtoaspecifictimeduringacase.Toaddageneralcommentforacase,

pressthe“Comment”buttonandakeyboardwillpop‐up.Typethecommentandpress“Save”.

Therecordedcommentdisplaywheneveryoupress“Comment”buttonandwillbelistedasa

“CaseComment”intheclinicalreport.

 Injections–commentforaspecificdrugadministration.Tomakeacommentaboutaninjection,

pressamedicationadministrationeventinthemedicationhistory.Thiswilldisplaythe“Modify

SelectedInjection”pop‐up.Pressthe“Comment”buttoninthepopuptodisplayakeyboard.

Typethecommentandpress“Save”.Thiscommentwilldisplaynearthedose/timewhenthe

commentwaswritten.

 Infusions–commentforaspecificdrugadministration.Tomakeacommentonaninfusion,

pressaninfusionevent.Thiswilldisplaythe“ModifySelectedInfusion”pop‐upscreen.Press

the“Comment”buttontodisplaythekeyboardtotypeacomment.Typethecommentand

press“Save”.Thiscommentwilldisplaynexttotheinfusionevent.



Figure 27 Add Comment

TransferPatientsfromOneCareAreatoAnother

ItisimportanttopreparethepatientandTabletcomputerpriortomovingthepatientfromonecare

areatoanother.Pressing“PauseCase”fromtheMenuinstructstheTabletcomputertodisconnectthe

IntelliportdevicetherebyenablinganotherTabletcomputerinasubsequentcareareatoconnecttoit.

TheIntelliportdevicewillremainwirelesslyconnectedtotheearliertabletif“PauseCase”hasnotbeen

pressedandthepatienthasbeenmovedtoasubsequentcarelocationthatiswithin30feetofthe

earlierTabletcomputer.Inthissituation,thecliniciancandisconnecttheIntelliportbypressing“Show

All”fromthePatientSetupscreenandfollowingthescreeninstructions.



46

WorkingwithOrders

TheAnesthesiaSystemsupportsmedicationordersathospitalsthatuseComputerizedPhysicianOrder

Entry(CPOE).WheninjectionsaregiveninperioperativenursingcareareasthatuseCPOE,theTablet

computercanmatchtheinjectiontoaphysicianorderandsendthisinformationtothehospital’sclinical

informationsystem.ObservethefollowingstepswhentheAnesthesiaSystemisconfiguredfor

medicationordersinthenursingcareareas:

1. Reviewthepatient’smedicationorderattheclinicalinformationsystem.

2. PreparethesyringeandIntelliportdeviceforuse.

3. AttachthesyringeforthemedicationordertotheIntelliportdevice.

Foranencodedsyringe,theTabletcomputercomparesthemedicationintheattachedsyringeto

pendingmedicationordersanddisplaysapopupconfirmingamatch.Verifythemedicationorder

matches.Ifcorrect,press“Select”.Ifincorrect,press“SelectOther”.



Figure28MedicationOrders

Foranunencodedsyringe,theTabletcomputerdisplaysapopuplistingtheactivemedicationordersfor

thepatientandpromptsthecliniciantoselectthemedicationcorrespondingtotheattachedsyringe.

HighlightthemedicationorderandpressSave.



47



Figure29SelectinganOrderwhenUsingUnencodedSyringes

RespondingtoMessages

TheAnesthesiaSystemprovidestwotypesofmessages:"System"and"Clinical.”"Clinical"messagesare

“alertsandreminders”thatrelatedirectlytoanaspectofpatientcaredelivery(e.g.contraindicationor

areminderthatitmaybetimetore‐doseantibiotics).Systemmessagesprovidestatusonrelevant

systemoperatingparameters.

Messagesprovideinstructionsandabuttonforacknowledgingorresolving.RefertoAppendixXfora

listofmessages.MessagesdisplayintheMessagesectionoftheTabletcomputeruntiltheyare

acknowledgedorarenolongerclinicallyrelevant.Messagescanbeansweredanytimeduringacase.

Priortopausingorclosingacase,aclinicianispromptedtorespond/answerunresolvedmedication

messagesgeneratedduringthecase.

ClinicalMessages

 Allergyalert‐Anallergyalertdisplayswhenaclinicianattachesanencodedsyringeorselectsa

medicationforanunencodedsyringetowhichthepatienthasaknownallergy.

 Antibioticredosingreminder‐TheTabletcomputertrackselapsedtimesinceanantibioticis

administeredanddisplaysanantibioticredosingmessageiftheconfiguredredosingintervalhas

elapsed.Theredosingintervalisindividualtoeachantibiotic,anditisconfiguredinthedrug

library.

 Medication‐TheTabletcomputertracksmedicationsgiventhatarereconstituted,dilutedor

givenascocktails,(mixedmeds)anddisplaysamessageforthecliniciantospecify.The

messageisindividualtoeachmedication,anditisconfiguredinthedruglibrary.



48

ReviewingtheMedicationRecord(forPaperAnesthesiaRecords)

TheAnesthesiaSystemrequiresthecliniciantoreviewthemedicationrecordforaccuracypriorto

printingareport.Thisiscalled“finalizing”anditensurestheaccuracyofthereport.

NOTEAclinicianisabletocorrectandamend(addinginformationto)thepatient’sthe

medicationrecordsolongasanIntelliportforthatpatientisconnectedandthecase

hasnotyetbeen“finalized”.

1. FromthemainMenu,Press“Reports”.

2. TheTabletcomputerwillprovideapopupwithmessagesforacliniciantoverifyoradjustthe

followingdata:

 Checkforreconstituted,dilutedormixedmedicationsgiven.Amessageisindividualtoeach

medication,anditisconfiguredinthedruglibrary.

 Checkformissinginfusiondata

 Checkformedicationsgiveninnursingareasbyananesthetistthataretobechartedinthe

anesthesiarecord

 Clockadjustment‐Press“Clock”toadjustthetimefortheprintedreportstosynchronizean

anesthetistclockwiththeflowsheet.Apopupdisplaysshowingaclockwithupanddown

arrowsforhoursandminuteadjustment.Press“Save”



Figure30ReviewCase

3. Ifthereareunresolvedmessages,thecliniciancancomebackandanswerthequestionsatany

timepriortoClosingthecase(CloseCase).

4. Press“ReviewedCaseandPrint”.Oncefinalized,themedicationadministrationhistoryfor

recordedmedicationadministrationswillnolongerbeeditable.

Ifallquestionsarenotansweredpriortocaseclosure,thecliniciancancomebackandanswerthe

questionsupto24hoursafterthecaseisclosed.Ifthe24hourwindowisexceeded,thecasecanonly



49

beprintedoutandchangesmanuallymadewithapen,signedanddatedbytheclinicianandsubmitted

toMedicalRecordstobeattachedtothepatient’selectronicrecord.

PrintingaReport(forPaperAnesthesiaRecords)

Thefollowingreportsareavailableforprinting:

 AnesthesiaFlowSheetRecord–Thisreportlistsofthemedicationsandinfusionsprovided

duringtheORsuiteinaflowsheetformat.ThisiscomparabletotheAnesthesiaRecordthatis

manuallyrecordedbyanesthesiologistsforallcases.

 ControlledSubstanceUsage‐Thisreportprovidesalistofallcontrolleddrugsusedduringthe

ORcase,withdoseamount,mLsusedandtimegiven.

 Handoff–Thisreportisusedasacommunicationtooltoconveyinformationpertinenttothe

ongoingcareofthepatient,especiallywhenthepatienttransfersfromonecareareatoanother

andanewprimarycaregiverassumescareofthepatient.

 PerioperativeMedicationAdministration‐Thisreportlistseachmedicationandfluid

administeredshowingthetime,dosageandroute.Italsoprovidesasummaryshowingtotal

dosagebymediationandfluid.

1. Toprintareport,pressReportsfromtheMenu.



Figure 31 Print Reports

2. Selecttheappropriatereporttoprint.

3. Specifytheprinter,ifdifferentfromdefault,andthenumberofcopies.

4. PressPrint.

AddressPendingMedications(EMRIntegration)

WhenconfiguredforEMRintegration,theTabletcomputersendsmedicationadministration

informationinrealtimeunlessinformationismissing.Themissinginformationincludesthedrug

name/concentrationofanunencodedsyringe,thedoseofareconstituteddrug,oruseofacocktail.In



50

thesesituations,theTabletcomputerretainsthismedicationadministrationinapendinglistuntilitis

resolvedbytheclinician.

NOTEItisgoodpracticetoresolvemedicationadministrationspriortoacaretransitionor

closingacase.(IFU032)

5. FromtheMenu,press“PendingMeds”.Apop‐uplistsmedicationadministrationsthatrequire

resolution.

6. Presseachitemtoresolve.Aseachresolutiononmedicationoccurs,thequerywilldisappear

andaresultingmedicationmessagewillindicatetheinformationsenttotheAnesthesia

InformationManagementSystem(AIMS)system.

DeactivateIntelliport,DisposeofIntelliportSensor,andPrepareIntelliportBaseforReuse

1. WhentheIntelliportdeviceisnolongerinuse;disconnecttheIntelliportSensorfromthe

IntelliportBasebysqueezingtogetherthetwofingertabsontopoftheIntelliportSensorwhile

liftinguptodisengagefromtheIntelliportBase.

2. Whenproperlyseparated,theIntelliportdevicewillpoweroffandnolongertransmits

wirelesslytoaTabletcomputer.

3. DisposeoftheIntelliportSensoraccordingtoyourhospital’smedicalwasteprotocols.

NOTEAvoidinadvertentlydiscardingtheIntelliportBaseafteruse.Itisintendedforreuse

withmultiplepatients.

4. CleananddisinfecttheIntelliportBase.Firstcleanitwithacommercialhospitaldisinfectant

andsecondly,disinfectitsecondlywithacommercialhospitaldisinfectant.Follow

manufacturer’sinstructions.Foralistofapprovedhospitalapprovedproductstouse,referto

AppendixX.

5. Allowittodry.

6. InspecttheIntelliportBaseforcracksordamage.Ifdamageisevident,thendisposeofit

accordingtoyourhospital’sprotocols.

7. ConnecttheIntelliportBasetotheRecharger.

NOTEIttakesapproximately2‐4hourstofullyrechargeanIntelliportBasewhendischargedto

<25%ofpower.

8. IftheIntelliportBasehasexceededitsUsefulLife,thendisposeofitaccordingtoyourhospital’s

protocolsforelectricalwaste.TheIntelliportBasecontainsaLithiumbattery.

NOTETheIntelliportBasewillilluminatearedlightwhilechargingifithasexceededitsUseful

Life.

PowerDowntheTabletcomputer

TheTabletcomputermayremainpowereddownbetweenuses.

1. ConfirmtheTabletcomputerdoesnothaveIntelliportdevicesconnectedanditisnolongerin

use.

2. Pressthe“Shutdown”buttonlocatedontheMenubar.



51

3. Press“Yes”,toconfirmandpowerdowntheTabletcomputer.





52

SectionVTroubleshooting

IntheeventyouexperiencedifficultyoperatingtheAnesthesiaSystem,thissectionofthemanual

providesatroubleshootingguideforoperationalproblems.Iftheresponsetoaspecificquestionisnot

found,contactyourServiceRepresentative:

Phone:

Website:

Email:

QuestionAnswer

HowdoIreturntotheClinical

MainScreenorHome?

FromMainMenupress“Anesthesia”or“Nursing”view.

WhatdoIdoiftheBatteryin

theBaserunsoutofcharge

duringacase?

ABasecanbeexchangedatanytimewithoutaffectingthecase.

Exchangestakelessthan30seconds.Ifitismorethan30seconds,the

casewillrequireresynchronizationofIntelliportdevicetoTablet

computer.



WhatifIpressed“CloseCase”

or“Shutdown”bymistake

duringanactivecase?

OnceyouresynchronizethepatientandIntelliportdevicetothe

Tabletcomputer,allinformationisretrievable,eveniftheIntelliport

Sensorisreplaced.

Whatcausesmetolose

historicalmedication

information?AndwhatcanI

dotoretrieveit?

Itisnotpossibletolosehistoricalmedicationinformationifthe

IntelliportdeviceandpatienthavebeensynchronizedtotheTablet

computer.MedicationsgivenpriortoIntelliportsynchronizationare

retainedinmemoryontheIntelliportBase.

WhatifIforgottocharta

medicationoridentifya

“SelectMed”andthepatient

isnowintheMed‐Surgflooror

ICU?

Ifithasnotbeenmorethan24hourssincetheORcase,thecasecan

beretrievedfromthehospitalserverandeditingofthecasecan

occurviaaTabletcomputer.However,ifgreaterthan24hours,the

casereportcanbeprinted,andmanualeditsmadewithdatesand

signaturesandreturnedtoMedicalRecordsforacaseupdate.

WhatdoIdoiftheIntelliport

Sensornolongerisworking

andthecaseisnotover?

AnIntelliportSensorcanbereplacedatanytime.Resynchronization

isrequired.

WhatifthecaseisoverandI

justnoticedthewrongpatient

appearsonthescreen?

GotoMainmenuandpressthe“RemovePatient”button.TBD.





53

SectionVICareandMaintenance

ObservethefollowingproceduresforcareoftheAnesthesiaSystem.ComponentsoftheAnesthesia

Systemdonotrequireusermaintenance.Therearenouserserviceableparts.

Care

CleanandDisinfecttheIntelliportBaseforReuse

1. CleantheIntelliportBasewithacommercialhospitaldisinfectant.ThendisinfecttheIntelliport

Basewithacommercialhospitaldisinfectant.(IFU0024)Foralistofapprovedhospitalcleaning

productstouseontheIntelliportBase,pleaserefertoAppendixB.

2. Allowittodry.

3. InspecttheIntelliportBaseforcracksordamage.Ifdamageisevident,thendisposeofit

accordingtoyourhospital’sprotocols.

RechargingtheIntelliportBaseforReuse

4. PlugtheRechargerintoanisolatedACoutlet.

5. AttachtheRechargertoacleananddisinfectedIntelliportBasebyjoiningtheRechargerand

IntelliportBasefrontsectionsfirst,thensnapthetwotogether.Oneshouldaudiblyhearthe

“snap”.

6. VerifyproperseatingofRechargertotheIntelliportBasebycheckingfora“charging”lighton

theIntelliportBase.Ifthisisnotseen,viewtheIntelliportdeviceonitssidetodetermineifthe

twoareproperlyconnected.IfaspaceisseenbetweentheRechargerandIntelliportBase,then

separateandre‐attachedproperly.

7. TheIntelliportBasewillilluminateshowingtheamountofchargeinthebattery.Refertothe

followingsectionshouldaredindicatorlightilluminate.

NOTEFourbarsindicateafullcharge.TheIntelliportBaseisnotdamagedwhenleftonthe

Rechargerafterbeingfullycharged.

CleananddisinfecttheRechargerbyusingtheprocedureusedfortheIntelliportBase.

DeterminingUsefulLifeforaIntelliportBase

TheIntelliportBaseisdesignedtobereusable.After500uses,thecomponentsmaybesusceptibleto

wearanditisnolongersuitableforusewithpatients.Usethefollowingproceduretodetermineifan

IntelliportBasehasexceededitsusefulLife.

NOTEAvoidusinganIntelliportBasethathasexceededitsUsefulLife.

1. ConnecttheIntelliportBasetoaRecharger.

2. IftheIntelliportBasehasexceededitsUsefulLife,thentheIntelliportBasewillilluminateared

lightwhilecharging.Ifso,discontinueuse.

NOTEIfanIntelliportBasehasexceededitsUsefulLife,thendisposeofitaccordingtoyour

hospital’sprotocolsforelectricalwaste.TheIntelliportBasecontainsaLithiumbattery.



54

ShouldanIntelliportBasebeusedafterithasexceededitsUsefulLife,amessagewilldisplaywhenthe

IntelliportdeviceiswirelesslyconnectedtotheTabletcomputerduringPatientSetup.Shouldyou

experiencethismessage,replacetheIntelliportBasewithanotherandrepeatthewirelessconnectionto

theTabletcomputer.

CleaningtheTabletcomputer

1. TurntheTabletcomputeroffanddisconnectthepowercable.

2. CleantheTabletcomputerwithasoftclothdampenedwithwater.Moistenasoft,lint‐freecloth

witheitherwateroradisplaycleaner,andwipethesurfaceoftheTabletcomputeruntilitis

clean.



Donotuseaerosolcleaners,whichmaycontainflammablesubstances.



DonotallowwaterfromtheclothtoseepdowntotheTabletcomputerportsandthe

buttons.



ToavoiddamagingtheTabletcomputerordisplay,donotspraycleaningsolution

directlyontothedisplay.

OnlyuseproductsspecificallydesignedforcleaningTabletcomputers,andfollowthemanufacturer’s

instructionsthatareincludedwiththeproduct.Foralistofapprovedhospitalcleaningproductstouse

onyourTabletcomputer,pleaserefertoAppendixF.

Storage

ComponentsoftheAnesthesiaSystemdonotrequireusermaintenance.Therearenouserserviceable

parts.ContactTechnicalSupportintheeventaTabletcomputerorIntelliportBaseisnotfunctioning

properly.

Tabletcomputer

Whennotinuse,theTabletcomputermayremainmountedandpoweredon,whenconnectedtoan

isolatedACpowersource.

NOTEDonotremovetheTabletcomputerfromitsprotectivecaseforstorage.

IntelliportBase

Whennotinuse,acleananddisinfectedIntelliportBaseshouldremainontheCharger.

NOTEDonotplaceanIntelliportBaseinstoragewithoutfirstcleaninganddisinfecting

accordingtoHospitalpolicy.

NOTEForhospitalsthatkeepaspareIntelliportBaseintheOR,besuretoperiodicallyswap

outIntelliportBasetoensureitisfullycharged.



55

IntelliportSensor

IntelliportSensorsarestoredinthesterilepackaging.



IntelliportSensorshavea“UseBy”datetoensuresterility.DiscardIntelliportSensors

thathavenotbeenusedbytheirUseBydate.

Maintenance

ComponentsoftheAnesthesiaSystemdonotrequireusermaintenance.Therearenouserserviceable

parts.ContactTechnicalSupportintheeventaTabletcomputerorIntelliportBaseisnotfunctioning

properly.

AdministrationandService

ToBeDetermined



56

SectionXIII.Appendix

AppendixAIntelliportTechnicalSpecifications

SpecificationDescription

Fluidconnection2ports,Luerlocktypefittings

Volumemeasurementaccuracy±5%

Injectionportcapacity100injections

Primevolume5mL

Deadvolume/retainedfluid0.3mLfollowinginjection

Exteriorsize(excludingtubing)<4.5cubicinches

Weight72gm(IntelliportBaseandIntelliportSensor)

OperationonaSinglecharge24hours

RechargespeedUpto4hoursfrom<25%

Wirelessrange(Intelliportdevice)5m

OperatingTemperature12˚C‐40˚C(IFU014)

OperatingHumidity20%to85%relativehumidity(IFU015)

ShippingandStorageTemperature‐20˚C‐60˚C

ShippingandStorageHumidity15%to90%relativehumidity







57

AppendixBDisinfectantAgents

ThefollowingdisinfectantsaresuitableforusewiththeIntelliportBaseandRecharger.

DisinfectantTypeofdisinfectant

CaviWipes1(ByMetrex)Alcohol‐basedquaternaryammonium

SuperSaniCloth(purpletop)(byPDI)Alcohol‐basedquaternaryammonium







58

AppendixCStandards

TheAnesthesiaSystemisintendedforuseunderthesupervisionofhealthcareprofessionalsonly.Thisis

aClassIImedicaldevice.TheAnesthesiaSystemconformstothefollowingstandards.

IEC60601‐1MedicalElectricalEquipment‐Part1.GeneralRequirementsforSafety

IEC60601‐1‐2CollateralStandard:Electromagneticcompatibility‐Requirementsandtesting









59

AppendixDGlossary

ThefollowingtermsareusedintheseInstructionsforUse.

ConfigurationThewaytheAnesthesiaSystemissetup,ortheassortmentofcomponentsthat

makeuptheAnesthesiaSystem.TheGatewaymanagestheconfiguration

settings.AllTabletComputersforacareareahavethesamesettings,exceptfor

wirelessandprinters.

EMRintegrated

mode

Systemconfigurationthatsupportsintegrationwithelectronicmedicalrecords

orperioperativeinformationmanagementsystems(PIMS)

EncodedSyringesSyringeshavingaspecialbarcodeidentifieronthetip

EncodingAspecialbarcodeidentifieronthetipofprefilledsyringes

GatewayAsoftwareapplicationthatenablestheAnesthesiaSystemtofunctionasan

enterprisedeviceandinformationsystem.TheGatewayprovidesacentralhub

towhichallTabletcomputersconnectviathehospitalnetwork.Italsoincludes

aninterfaceenginefortheAnesthesiaSystemtoexchangedatawithother

networkedhospitalinformationsystems,alongwithasuiteofutilitiesforgeneral

Gatewayimplementation,operation,andmaintenance.

InjectionportThesplitseptumportontheIntelliportSensorwherethesyringeattaches

IntelliportBaseTheIntelliportBaseisanon‐sterile,reusabledevicethathousestheelectronics

andwirelesstransmitter.Itisbatterypowered,andrechargeable.Aseparate

ChargerrechargesthebatteryinthereusableIntelliportBasepriortoeachuse.

IntelliportdeviceAnintelligentinjectionport.Itattachestoaninjectionsite(“YSite”orstopcock)

formanuallyadministeredIVinjections.ItiscomprisedofaIntelliportSensor

andaIntelliportBase,whichsnaptogetherpriortouse.

IntelliportSensor AIntelliportSensorisasteriledisposabledevicehavinganinjectionportanda

Luerconnection.TheIntelliportSensorissuppliedinasterilepackageforsingle

patientuse.

Luer‐lok Astandardfittingusedformakingleak‐freeconnections.Aluerfittingthat

securelylockstogetherusingthreads.

Non‐encoded

syringes

Syringesthatdonothavespecialencodingonthetip.TheIntelliportdevice

cannotidentifythedrugcontentsofthistypeofsyringe.

PerioperativeDrug

Library

TheAnesthesiaSystemoperatesusingthehospital’sperioperativedruglibrary.

TheGatewaymanagesthedruglibrary.Whenanunencodedsyringeisattached,

thepicklistisderivedfromtheperioperativedruglibrary.

RechargerAseparateRechargerrechargesthebatteryinthereusableIntelliportBaseprior

toeachuse.

Stand‐alonemodeSystemconfigurationthatsupportsapaperanesthesiarecord



60

TabletcomputerAcommercialTabletcomputerwithembeddedsoftwarefortheAnesthesia

Systemoperation.Itcontinuouslycapturesanddisplaysthemedication

administrationrecord(MAR)datafromtheIntelliportdeviceeachtimean

injectionoccurs.Italsoenablesclinicianstomanuallydocumentotherpertinent

clinicalinformation,anditprovidesclinicaldecisionsupporttohelpimprove

safetyandaidcliniciansduringtreatment.Informationtechnologywirelessly

transfersthedatatotheGateway.







61

AppendixEASADrugCategoryColorSchema





62

AppendixFMessages



Name&TriggerMessageText ClearingtheMessage

1.Tabletcomputersoftwareisunableto

verifyitsconfigurationsettings(e.g.

nowirelesstoGateway)

Softwareconfigurationor

formularyversionscannotbe

verified.Usingcurrentsettings.

Notifyyoursystem

administrator.

‐Persistswithbootup

screen.

Willtimeoutin10

seconds.

2.WhiletheTabletcomputersoftwareis

receivingandupdatingtheTablet

computersoftwareConfiguration

Profile.

UpdatingDPM,configuration

toversion[xx].

‐Persistswhileupdating

file(s)

3WhiletheTabletcomputer softwareis

receivingandupdatingtheDrug

Formulary.

UpdatingFormularytoversion

[xx].

‐Persistswhileupdating

file(s)

4ConfigurationupdatenotsuccessfulNewconfigurationsettingsnot

updated.Usingcurrent

settings.Notifyyoursystem

administrator.

‐Persistswithbootup

screen

5IntelliportBase‐EndofLife‐

Intelliportdevicetransmits#ofuses

uponsynchronization.

Intelliportdevicehasreached

itsendoflife

‐OKclearsthemessage

‐Confirm(completes

patientassociation)

6Drugconnectedorsubsequently

identifiedmatchesacontraindicated

drugbasedonthepatient’sallergy

Screen‐“[Drugname]‐

PotentialAllergyReaction”

Patienthasaknownallergyto:

[allergydescription]

“Severity:”[severity]

“Reaction:”[reaction]

‐OKbutton

‐Automaticallyupon

syringedisconnectifnot

pushed.

7Antibioticredosingintervalexceeds

configurationvaluefortheantibiotic.

[AntibioticDrugName]given

X.Xhoursago.Consider

redosing.

‐OKbutton

‐Automaticallyupon

subsequentantibiotic

injectionconnected/

identified.

8Thedrugconnectedorinjectedhas

beenidentifiedasfrequentlydiluted

inconfiguration.

“PressHereif[DrugName]was

dilutedbeforegiven.

‐PressingtheDilution

messagetextopensthe

manualinjectionentry

screenwithvolumeand

dosefieldseditable.

9Thedrugconnectedorinjectedhas

beenidentifiedasfrequentlymixedin

configuration.

“PressHere”if[DrugName]

wasmixedbeforegiven.

‐PressingtheMixed

messagetextopensthe

manualinjectionentry



63

Name&TriggerMessageText ClearingtheMessage

screenwithfieldsfora

seconddrug.

10Tabletcomputersoftwarereceives

unmeasuredinlieuofvolumefrom

theIntelliportdevice

“Amountinjectednot

measured”.“PressHere”to

enterthevolumegiven.

‐PressingtheNot

Measuredmessagetext

opensthemanual

injectionentryscreen

withcursorfocuson

volumefield.

11Intelliportdevicetransmitsalow

batterymessage

LowIntelliportbattery(10%

remaining).ReplaceIntelliport

Base.

‐Automaticallyupon

Intelliport

unsynchronizationor

IntelliportBase

replacement.

12Intelliportdevicetransmitsapowering

downmessage

LowIntelliportbattery.

Intelliportdevicepowered

down.

‐Automaticallyupon

synchronizationof

Intelliportdevicehaving

lowbattery.

13Tabletcomputerhaslessthan20

minutesofpowerremaining

LowTabletcomputerbattery.

(10%remaining).

‐Automaticallywhen

TabletcomputeronAC

power

14Tabletcomputersoftwarepowering

downmessage

LowTabletcomputerbattery.

Tabletcomputerpowering

down.

N/A

15AnIntelliportdeviceisnolonger

communicatingwiththeTablet

computersoftwareafter5secondsof

pollingbytheTabletcomputer

software

Intelliportwirelessconnection

lost.

‐Automaticallyupon

Intelliport

synchronizationofsame

serialnumberIntelliport

Sensor/IntelliportBase.

16AnIntelliportdevicehasbeen

connectedcommunicatingwiththe

Tabletcomputersoftwareafterpolling

bytheTabletcomputersoftware.

Intelliportwirelessconnection

restored.

‐1minutetimeout.

17Intelliporterrorconditiontransmitted

toTabletcomputersoftware

Intelliporterroroccurred.

ReplaceIntelliportBase.

‐Press”Clear”if

resolved

18Intelliporterrorconditiontransmitted

toTabletcomputersoftware

Tabletcomputererror

occurred.RestartTablet

computer.

‐OKbutton.

‐Press“Clear”if

resolved

19Tabletcomputersoftwareerror

conditionpresent

Tabletcomputererror

occurred.RestartTablet

computer

‐OKbutton

‐Press“Clear”if

resolved

20UserpressesShutDownbuttonwith

noIntelliportdevicessynchronized.

Tabletcomputershutting

down.

N/A



64

Name&TriggerMessageText ClearingtheMessage

21UserpressestheShutDownbutton

whileanIntelliportdeviceis

synchronized.

ShutDowntheTablet

computeranddisconnectthe

Intelliportdevice?

Yes–continuewith

shutdown

No–cancelshutdown

22UserpressesPrintbuttonon

ReportingScreen

PrintingtoXXXprinter.N/A

23Failedlogin.UserNameandPassword

combinationnotvalid

TextprovidedbyGatewayor

“IncorrectPassword.Re‐enter”.

Nextloginattempt



24DoseexceedsorderedDose“Checkdoseonorder”Syringeisdisconnected

25IntelliportSensornotprimed.No

SensorsignalatinitialIntelliport

Sensorattachment

“PrimeIntelliportSensor

beforeuse”

IntelliportSensorsignal

levelachieved.

26AirdetectedintheIntelliportSensor.

Occursafterproperprimingwithfluid

andairentrappedintheIntelliport

Sensor.

“AirdetectedintheIntelliport

Sensor”.

IntelliportSensorsignal

levelachieved.

(returned)







65

AppendixGAccessories

 Charger(partnumber2284)‐ThisaccessoryisusedtorechargetheIntelliportBasein

preparationforreuse.



 Radio(partnumber2285)–ThisaccessoryisusedbytheTabletcomputertocommunicatewith

Intelliportdevices.





66

AppendixHRadioFrequencyWirelessTechnology

TherearetwowirelesstechnologiesusedintheAnesthesiaSystemasdepictedinFigureXbelow.

Hospital

Wireless

Network

Gateway

Intelliport

TabletComputer 802.11 - Clinical Data

to/from Tablet to Gateway

2.4 GHz. - Medication administration data

to/from Intelliport to Tablet Computer



Theradiofrequency(RF)signalpowerhasbeenlimitedtoaverylowleveltonegateany

electromagneticpotentialinterferenceinco‐existencewithothermedicaldevices.Bothwireless

technologiesutilizedhavebeenapprovedforusebythe(FederalCommunicationsCommission)FCCand

meetFederalEMCandEMIguidelines.IntheeventofapotentialsignallossoftheseRF

communicationsa“lostwirelesslinkmessage”willbedisplayedontheTabletcomputertoinformthe

operator.TheTabletcomputerwillindicatewhencommunicationsareresumed.Informationonproper

set‐up,configurationandperformancewiththeHospitalNetworkisprovidedattimeofsystem

installation.Noset‐upisrequiredforIntelliportdevicetoTabletcomputercommunications.

Confirmationofappropriatepatientidentificationisrequired.



Othermedicalequipmentsuchasanelectrosurgicalunit(ESU)maybrieflyinterfere

withthesewirelesscommunications.Communicationsshouldautomaticallyresume

aftertheinterferenceandlostmessageswillberesent.TheTabletcomputerwill

indicatewhenlostcommunicationsexist.TheIntelliportstatusindicatorwilldouble

blinkwhencommunicationwiththeTabletcomputerislost.

IntelliporttoTabletcomputer

TheTabletcomputerusesanIntelliportRadiotowirelesslycommunicatewiththeIntelliportdevice

usinganRFsignalat2.4GHztoformalocalmedicaldevicenetwork.AnumberofIntelliportdevices

andTabletcomputersmaybeusedinthesamevicinitysuchasaPre‐operativecareareaoraPACU.A

licensehasbeenissuedbytheFederalCommunicationsCommission(FCC)tooperatethismedical

deviceinhospitalsandclinics.TestinghasbeenperformedtodemonstrateconformancetoIEC60601‐1‐

2forthecorrect,timelyandsecuretransmissionofmedicaldata(injecteddrugidentificationcodesand

volumemeasurements)andalertmessages.AlertmessagesarecommunicatedbetweentheIntelliport

deviceandtheTabletcomputertoadvisetheUserofvariousoperationalcharacteristicsofthesystem.

Someofthesealertsinformtheoperatorofpotentialhazardoussituationstoallowuseractionto

preventharmtothepatientorlossofmedicaldata.

Intelliportdevicesusingproprietary2.4GHztechnologyareassociated(linked)withspecificpatients

usingtheTabletcomputerIEEEstandardsbasedon802.11a/b/n(2.4GHz‐5GHz)technology.TheUser

identifiestheIntelliportSensorbyserialnumberandselectsaspecificpatientfromthehospital’spatient



67

listing.AllmedicationadministrationdatafromtheIntelliportdeviceistransferredtothespecific

patient’smedicalrecord.Intheeventofacommunicationloss,medicationadministrationdatawillbe

storedlocallyattheIntelliportdeviceandtransferredtotheTabletcomputerwhencommunicationsare

resumed.

TabletcomputertoGatewaythroughtheHospitalNetwork

TheTabletcomputerwirelesslycommunicateswiththeexistingHospitalNetworkusingastandards

basedIEEE802.11a/b/g/nenterpriseWLANnetwork.ThenetworkingtopologythatincludesthisTablet

computerwillfollowthebestofpracticedeploymentguidelinesthatcomplieswiththerightqualityof

service(QoS)andsecurity.TheGatewaysoftwareandaccompanieddatabasewillbeapartofthe

hospital’senterpriseinformationsystem.AnumberofTabletcomputersmaybeconnectedtothe

healthcareenterprisewirelessnetworkandtotheintendedGatewaysoftwareanddatabase.The

GatewayandaccompanieddatabaseprovidesalistofpatientsfortheUsertoselectandaFormulary

libraryofmedicationsandfluidsforinjectionorinfusion.Actualmedicationandfluidadministration

dataissenttotheGatewayandaccompanieddatabaseforrecordkeeping.Oncerecordedonthe

Gatewayandaccompanieddatabasethisdataisautomaticallyavailableinothercareareaswhenthe

patientistransferredandtheIntelliportdeviceiswirelesslyconnectedtoaTabletcomputer.

SummaryofIEC60601‐1‐2TestingandSpecifications

SpecificationsIntelliporttoTabletcomputerTabletcomputertoHospital

NetworkandGateway

TechnologyType2.4GHzproprietarymessaging802.11ab,g,nsecurewireless

connectionwiththecorrectqualityof

service(QoS)

EffectivePower 

Effectivetransmission

distance

10metersorlessXxmeterstohospitalwirelessaccess

point(WLANAP)

Datathroughputand

latency

Real‐timeinformation,nodelaysSubjecttohospitalnetwork

performance

LostCommunications

MessageontheTablet

computerdisplay

“Intelliportcommunicationlost”“Gatewaycommunicationlost”

Limitations3IntelliportdevicestooneTablet

computer

200TabletcomputerstoHospital

NetworkandGateway

FCCLicense########

Limitationsfoundduring

testingtoIEC60601‐1‐2

Xxxx



Nottested–conformstoIEEE802.11

standards.



68

QualityofService 

WirelessCoexistence 

Securityofwireless

signal/data



EMCinformation 







69

AppendixIReferenceDocuments

AvailabledocumentationandtrainingfortheAnesthesiaSystemincludes:

OrderNumberDocumentName

2300AnesthesiaSystemInstructionsforUse

XXXXXAnesthesiaSystemQuickReferenceCards

XXXXXUserTrainingVideoandDVD





70

AppendixJDescriptionofSymbols

ThefollowingsymbolsareusedbytheAnesthesiaSystem.

SymbolDescription



Warnings

IPX2 IngressProtectionfromfallingwaterdrops



Refertouseroperatinginstructions



Donotuseifpackageisdamagedorprotectorcapisunattached.



TypeBF/DefibrillationProofappliedpart



SingleUseOnly.Donotreuse!



Identifiesthecomponentmanufacturer



Keepdry



Uppertemperaturelimit



ExpirationDate,endofshelflifeDecember,2013



Lotnumber

SterileEO



SuppliedSterile,EthyleneOxidegas







71



BectonDickinson

1BectonDrive

FranklinLakes,NJ07417

Phone:(xxx)xxx‐xxxx

Fax:(xxx)xxx‐xxxx



RevisionDate:2/21/2013

PartNo.: 2300_R1FCC‐IC



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

CRISI Medical Systems Manual Injection monitoring system for anesthesia

User manual

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