Invivo Expression 865214 User manual

MRIPatientMonitoringSystem
Model865214
EXPRESSSERVICEMANUAL
*989803162701*
989803162701Rev.D


ProprietaryInformation
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Manufacturer
InvivoCorporation
12501ResearchParkway
Orlando,FL32826
(407)275‐3220
(800)331‐3220
www.invivocorp.com
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makesnowarrantyofanykindwithregardtothismaterial,including,butnotlimitedto,theimplied
warrantiesormerchantabilityandfitnessforaparticularpurpose.InvivoCorporationshallnotbeliable
forerrorscontainedhereinorforincidentalorconsequentialdamagesinconnectionwiththe
furnishing,performance,oruseofthismaterial.
LimitsofLiability
Invivohastakencaretoensuretheaccuracyofthisdocument.However,Invivoassumesnoliabilityfor
errorsoromissionsandreservestherighttomakechangeswithoutfurthernoticetoanyproducts
hereintoimprovereliability,function,ordesign.Invivomaymakeimprovementsorchangesinthe
product(s)orprogram(s)describedinthisdocumentatanytime.
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indicatethecurrent edition.
P/N989803162701Rev.D
Copyright©2010,InvivoCorporation
Allrightsreserved.PrintedinU.S.A


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Contents
1Introduction.....................................................................................................................1
1.1AboutthisManual...........................................................................................................1
1.2TextConventions.............................................................................................................1
2UnpackingtheSystem......................................................................................................3
3SystemOverview..............................................................................................................5
3.1 CartConfiguration............................................................................................................5
3.2PatientManagementConfiguration................................................................................5
3.2.1BatteryOperation:Cart,PMC,andDCU....................................................................6
3.2.1.1InstallationandRemoval......................................................................7
3.2.2BatteryOperation:WECGandWSpO2Modules......................................................8
3.2.2.1InstallationandRemoval......................................................................9
3.2.3SafeBatteryUse............................................................................................................9
3.2.4BatteryChargingInstructions....................................................................................10
3.2.5BatteryDisposalInstructions....................................................................................10
3.2.5.1GuidelinesinEurope...........................................................................11
3.2.5.2GuidelinesintheUnitedStates..........................................................11
4SystemInstallation.........................................................................................................13
4.1PowerSupply.................................................................................................................13
4.1.1PartNumber989803169201.....................................................................................13
4.1.2PartNumber989803168201.....................................................................................15
4.2CartConfiguration..........................................................................................................16
4.3PatientManagementConfiguration(PMC)...................................................................17
4.4DisplayControlUnit(DCU)............................................................................................18
4.4.1InstalledontheCart...................................................................................................18
4.4.2StandAloneOperation...............................................................................................19
4.5AdditionalInstallationOptions......................................................................................21

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5SystemPower‐Up...........................................................................................................23
5.1RemovingACMainsPower............................................................................................23
6TestandInspection........................................................................................................25
6.1WhentoTest..................................................................................................................25
6.2TestandInspectionMatrixChecklist.............................................................................25
6.3PerformanceAssuranceTestChecklist..........................................................................26
6.4RecommendedFrequencyofTesting............................................................................27
6.5TestProcessDescription................................................................................................28
6.5.1TestEquipmentRequirements.................................................................................28
6.5.2InitialACPower‐Up.....................................................................................................28
6.5.2.1ETCO2OptionOnly.............................................................................28
6.5.3OperationalTests........................................................................................................28
6.5.3.1SystemCommunicationVerification..................................................29
6.5.3.2WECGCommunication........................................................................29
6.5.3.3WSpO2Communication......................................................................30
6.5.3.4NIBPVerification.................................................................................31
6.5.3.4.1PneumaticLeakTestHigh(1strow)..................................31
6.5.3.4.2PneumaticLeakTestLow(2ndrow)..................................31
6.5.3.4.3NIBPOffsetVerification....................................................31
6.5.3.4.4CalibrationAccuracyCheck...............................................32
6.5.3.4.5OverpressureAdult...........................................................32
6.5.3.4.6OverpressureNeonatal.....................................................33
6.5.3.4.7AdultCuffTest..................................................................33
6.5.3.4.8AdultDeadManCuff........................................................34
6.5.3.4.9Neo‐NatalBP.....................................................................34
6.5.3.4.10Neo‐NatalDeadManCuff.................................................35
6.5.3.4.11LeakTimeOut,Adult........................................................35
6.5.3.4.12LeakTimeOut,Neo‐Natal.................................................35
6.5.3.4.13CalibrateError...................................................................36

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6.5.3.5InvasivePressureVerification.............................................................36
6.5.3.6AgentsVerification..............................................................................37
6.5.3.6.1AgentsFlowTest...............................................................37
6.5.3.6.2 O2SensorVerification......................................................39
6.5.3.7ETCO2FlowTestVerification..............................................................39
6.5.3.8RespirationVerification......................................................................40
6.5.3.9TemperatureVerification...................................................................40
6.5.4ElectricalSafetyTesting.............................................................................................40
7RemovalandReplacement.............................................................................................41
7.1TheCartWPU.................................................................................................................41
7.1.1WPURemovalfromtheCart.....................................................................................41
7.1.2WPUReplacementintotheCart...............................................................................45
7.1.3ExchangeNetworkSetup...........................................................................................48
7.1.3.1NetworkChannelOptions...................................................................48
7.1.3.2ExchangeParameterDisabling...........................................................49
7.2ThePMCWPU................................................................................................................49
7.2.1WPURemovalfromthePMC....................................................................................49
7.2.2WPUReplacementintothePMC..............................................................................54
7.2.3ExchangeNetworkSetup...........................................................................................60
7.2.3.1NetworkChannelOptions...................................................................60
7.2.3.2ExchangeParameterDisabling...........................................................61
8ServiceParts...................................................................................................................63
8.1Non‐ExchangeServiceParts..........................................................................................63
8.2ExchangeServiceParts..................................................................................................65
8.3SystemPreventativeMaintenanceParts.......................................................................66
8.4ServiceNumbersandReplacement/ExchangeParts.....................................................66
9ListofSymbols................................................................................................................69

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1INTRODUCTION
ThisExpressServicemanualisintendedforusebyqualifiedservicepersonnelfortherepairand
maintenanceoftheExpressionMRIPatientMonitoringSystem.Thismanualcontainsinformation
regardingtheinstallation,intendeduse,accessories,andtroubleshootingofafullyequippedExpression
MRIPatientMonitoringSystem.Theterms“Cart”and“PatientManagementConfiguration(PMC)”are
usedthroughoutthisdocumenttorefertotheconfigurationsoftheExpressionMRIPatientMonitoring
System.Specificdifferencesbetweenavailableconfigurations,whereapplicable,arenotedinthetext.
Someinformationinthismanualmaydepictmonitoringfeaturesthatyoursystemdoesnotcontain.For
informationonfeaturesandenhancementsthatarenotincludedinyoursystem,contactInvivo
Corporationat(800)331‐3220oryourInvivosalesrepresentative.Foradditionalinformationaboutyour
accessories,pleaseconsultthedocumentationthataccompaniedtheaccessory.
1.1AboutthisManual
Thismanualcontainsthefollowingsections:
Section1:Introduction,page1.
Section2:UnpackingtheSystem,pages3–4.
Section3:SystemOverview,pages5–11.
Section4:SystemInstallation,pages13–21.
Section5:SystemPower‐Up,page23.
Section6:TestandInspection,pages25–40.
Section7:RemovalandReplacement,pages41–61.
Section8:ServiceParts,pages63–67.
Section9:ListofSymbols,pages69–72.
1.2TextConventions
ThemanualusesthefollowingconventionsforWarnings,Cautions,andNotes:
WARNING:
AWarningcallsattentiontoaconditionorpossiblesituationthatcouldcause
injurytotheuserand/orpatient.
CAUTION:
ACautioncallsattentiontoaconditionorpossiblesituationthatcoulddamageor
destroytheproductortheuser’swork.
Note: ANotecallsattentiontonotabledetailsortoconventionsusedwithinthistext.

Section1:Introduction
WARNING:THISPAGECONTAINSCOPYRIGHTEDMATERIALSTHATARECONFIDENTIALAND/ORPROPRIETARY.ANYRELEASEORDISTRIBUTION
OFTHISMATERIAL,WITHOUTPERMISSION,ISAVIOLATIONOFLAW.
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WARNING:THISPAGECONTAINSCOPYRIGHTEDMATERIALSTHATARECONFIDENTIALAND/ORPROPRIETARY.ANYRELEASEORDISTRIBUTION
OFTHISMATERIAL,WITHOUTPERMISSION,ISAVIOLATIONOFLAW.
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2UNPACKINGTHESYSTEM
ThissectionprovidesinstructionsregardingtheunpackingandinspectionoftheExpressionMRIPatient
MonitoringSystem.Removethesystemcomponentsfromtheshippingcontainer(s).Verifythe
presenceofallordereditemsagainsttheincludedpackinglistandpurchaserequest.Carefullyexamine
allcomponentsforanydamagethatmayhaveoccurredduringshipment.Savethepackingmaterials
andrelatedshippingdocuments,asthesewillberequiredtoprocessaclaimwiththecarrierifdamage
duringshipmentoccurred.Toresolveanyissuesorconcernswithyourorderorproduct,ortoreport
shippingdamage,contactInvivoCustomerService;seeWarranty.
CAUTION:
TheExpressionMRIPatientMonitoringSystemmustbeusedandstoredaccordingtothe
environmentalspecificationsinAppendixAoftheInstructionsforUse(IFU)manual.
FailuretofollowthesespecificationscanaffecttheaccuracyoftheExpressionMRI
PatientMonitoringSystem.
1.Openthe4Snapsthatsecurethelidtothecrate.RemovethelidandFoamInsertCfromthecrate.

Section2:UnpackingtheSystem
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2.RemovetheAccessoriesBoxandFoamInsertB.
3.RemoveFoamInsertAandunlockthewheelsoftheCart.
4.CarefullyraisethecrateandthenrollouttheCart.

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3SYSTEMOVERVIEW
Dependingonthesystem,theExpressionMRIPatientMonitorhasseveralpossibleconfigurations.
3.1 CartConfiguration
TheCartconfigurationconsistsofthefollowingprimarycomponents:
OneCart,includingtheWirelessProcessingUnit(WPU)
OneDisplayControlUnit(DCU)
OneWirelessECG(WECG)Module
OneWirelessWSpO2(WSpO2)Module
TwoWirelessModuleBatteries
FourCart/DCUBatteries
OneDCUPowerConverterKit
OnePowerSupply
TheDCUmaybedockedontheCartorlocatedremotely;seetheExpressionIFUfordetails.When
dockedontheCartandwiththeCartconnectedtoACmainspower,theDCUandCartbatteriesare
chargedthroughthebatterychargercontainedwithintheCart.Foraddedflexibility,thesystemcan
beconfiguredwithtwoadditionalDCUs.TheadditionalDCUscanbelocatedintheMRsystem
room,MRcontrolroom,orMRholdingarea.RefertotheExpressionIFUforwarnings,cautions,and
instructionsregardingtheDCU.
3.2PatientManagementConfiguration
ThePatientManagementConfiguration(PMC)consistsofthefollowingprimarycomponents:
OnePatientManagementConfiguration(includingtheWPU)
OneDCU
OneWECGmodule
OneWSpO2module
TwoWirelessModuleBatteries
FourPMC/DCUBatteries
OneDCUPowerConverterKit
PowerSupply(s):onewithdualDCOutputs,ortwowithsingleDCOutputs
SeveraloptionsareavailablefortheplacementofthePMC,including:
Horizontalmountingtoapatientexaminationtable;
Verticalmountingtoapatientexaminationtable;
Mountingtoananesthesiacart;and,
Mountingtoastationarysurface.
WiththePMCconnectedtoACmainspower,thebatterieswithinthePMCarechargedthroughthe
internalbatterycharger.TheaccompanyingDCUcanbelocatedintheMRsystemroom,MRcontrol
room,orMRholdingarea.Foraddedflexibility,thesystemcanalsobeconfiguredwithtwo

Section3:SystemOverview
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additionalDCUs.RefertotheExpressionIFUmanualforwarnings,cautions,andinstructions
regardingtheDCU.
3.2.1BatteryOperation:Cart,PMC,andDCU
TheCart,PMC,andDCUbatteriesareinterchangeable.Dependinguponyourequipment
type,thenumberandlocationofthebatteries(P/N989803169491)willdiffer:
TheCarthastwobatteries
locatedontheundersideofthe
unit.
TheDCUhastwobatteries
locatedontheleftandright
sidesoftheunit.
ThePMChastwobatteries
locatedbeneaththelatchedtop
coverontheunit.
ThelowerportionoftheDCUcontainstheSystemStatusarea,dedicatedtodisplayingthe
batteryandwirelesscommunicationstatus;seeSection6.5.3.(RefertoExpressionIFU
manualforafullexplanationoftheBatteryStatusDisplay.)Maximumoperationtimeofthe
Cart,PMC,andDCUbatteriesisapproximately8hourswhenanestheticagentsandCO2are
turnedoff,andNIBP,ECG,andSpO2parametersarerunningat5‐minuteintervals.Battery
operationtimewillbereducedbyupto2hourswhenperformingcertainoperationssuchas
anestheticagentsmonitoring,printingchartsandtrends,orrunningshortautomaticNIBP
cycletimes.

Section3:SystemOverview
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WhentheACmainspowerisinterruptedandbatteriesintheCart,PMC,andDCUare
inserted,theExpressionautomaticallyswitchestointernalbatteries.
Note:
Topreventunintentionalpowerinterruption,Invivorecommendskeepingthe
batteriesinsertedintheequipment,evenwhenoperatingunderACmains
power.
3.2.1.1InstallationandRemoval
WARNING:
ThebatteriesusedwithintheCart,PMC,andDCUcontainsome
ferrousmaterialsthatareattractedtotheMRmagneticfield.DO
NOTinstallorremovethebatteriesfromthedeviceswhenthese
unitsarecloserthanthe1,000Gauss(0.1T)fieldlineasmeasured
fromthecenterlineoftheMRbore.Thebatterieswillbe
attractedtothemagneticfield,possiblycausingpatientoruser
injury.
CAUTION:
Neverforceabatteryintothebatterycompartment;damageto
thebatteryortheExpressionMRIPatientMonitoringSystemwill
occur.
ToinstallbatteriesintotheCart,PMC,andDCU,thebatteriesmustbeoriented
properlytolatchintoplaceinthebatterycompartments,asthebatterycontoursfit
thedevicegeometry.Slidethebatteriesintotheirrespectivecompartmentsand
theywillautomaticallylatchintoplace.Ifthebatterydoesnotlatchautomatically
whenfullyinsertedintothebatterycompartment,thenthebatteryisnot
positionedproperly.Inthiscase,reorientthebatterythenretryinstallation.
ToinstallbatteriesinthePMC,followthestepsbelow.

Section3:SystemOverview
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StepBatteryInstallation–PMC
1.MovethePMCawayfromtheMRsystem,outsideofthe1,000
Gauss(0.1T)fieldline(asmeasuredfromthecenterlineoftheMR
bore),priortoinstallingbatteries.
2.RemovetheBatteryCompartmentCoverbyliftingthelatches.
3.Slidethebatteriesintotheirrespectiveholderuntilseated(referto
thefollowingfigures).
4.InstalltheBatteryCompartmentCover.
5.AssurethattheBatteryCompartmentCoverislatchedintoplace.
ToremovebatteriesfromtheCartandDCU,pressthebatteryejectbuttononthe
deviceandthebatterywillpartiallyejectforeasyremoval.
ToremovebatteriesfromthePMC,followthestepsbelow.
StepAction
1.MovethePMCawayfromtheMRsystem,outsideofthe1,000
Gauss(0.1T)fieldline(asmeasuredfromthecenterlineoftheMR
bore),priortoremovingbatteries.
2.RemovetheBatteryCompartmentCoverbyliftingthelatches.
3.Pullthelatchholdingthebatterywithonehand.
4.Usingyourotherhand,pullthebatteryout(fromthesideopposite
theconnector)ofthePMC.
3.2.2BatteryOperation:WECGandWSpO2Modules
TheWSpO2andWECGmoduleshaveinterchangeablebatteries(P/N9065).Thesebatteries
slideandlatchintothebatteryslotsintheWECGandWSpO2modules.

Section3:SystemOverview
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3.2.2.1InstallationandRemoval
CAUTION:
The9065Batteryandwirelessmoduleshouldnotbeplacedinthe
FieldofViewtominimizethechanceofimageartifact.
Note:
TheWECGandWSpO2modulebatteriesarenon‐magneticandcanbe
removedandreplacedfromthemoduleswhileintheMRmagnetic
field.
ToinstallbatteriesintotheWSpO2andWECGmodules,slideabatteryintothe
batteryslotinthemoduleuntilthebatterylatches(oneachside)intoplace.
ToremovebatteriesfromtheWSpO2orWECGmodules,simultaneouslypressthe
latchesonbothsidesofthebatterythenslidethebatteryoutofthemodule.
3.2.3SafeBatteryUse
Thefollowingwarnings,cautions,andnotesshallbeobservedtoensurethesafetyof
operatorsandpatients.
WARNING:
Stopusinganybatterythatexhibitsabnormalheat,odor,color,
deformationorisinanabnormalcondition.Ifabatteryispuncturedor
liquidleaksontoyourskinorclothing,washskinandclothingwithfresh
waterimmediately.Ifliquidleaksfromabatteryandgetsintoyoureyes,
donotrubyoureyes.Washeyeswellwithcleanwaterandconsulta
doctorimmediately.
CAUTION:
Ifthebatteryterminalsbecomedirty,wipethemwithacleandrycloth
beforeuse.
Keepthebatteryterminalsawayfrommetalobjects.
Note:
Batterieshavelifecycles.Ifthetimethatthebatteryispoweringthe
equipmentbecomesmuchshorterthanusual,thebatterylifeisatanend.
Removeabatterywithanexpiredlifecyclefromtheequipment
immediately.ReplacethebatterywithanewInvivospecifiedbattery.Refer
toSection8forpartnumbers.

Section3:SystemOverview
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3.2.4BatteryChargingInstructions
Chargethebatteriesbeforeuse.Wheninstallingthesystemforthefirsttime,allbatteries
mustbechargedatleast12hourswithACpowertotheExpressionturnedoffsothatthe
batteriesarefullychargedandconditionedforoperation.
TheCart,PMC,andDCUbatteriesarechargedbyintegratedintelligentbatterychargers.
Theseintelligentchargingdevicesautomaticallyprovidetheappropriateprofileneededto
efficientlychargeandconditionthebatteries.WhentheCart,PMC,andDCUareplugged
intoACpowerandturnedoff,thebatterychargerisfunctionalandwillautomaticallycharge
thebatteries.WhentheCart,PMC,andDCUareturnedON,theyoperatefromACpower
andchargethebatteriessimultaneously.
WhentheCart,PMC,andDCUbatteriesareremovedfromthesystem,theusercan
determinebatterycapacitybypressingthebattery’sPowerLevelbuttonthenobservingthe
LEDs.TheLEDsindicatethebatterycapacity,in20percentincrements,from20–100
percent.IndicationsofbatterycapacityarealsoavailableviatheDCU;seetheExpression
IFUmanual.Theminimumbatteryvoltagevaluefornormaloperationis14.8V.
TheWirelessECGandSpO2modulebatteriesmustbechargedbythestand‐aloneInvivo
batterycharger(P/N9023).Refertotheinstructionsandcautionsprovidedwiththebattery
chargerformoreinformation.IndicationsofbatterycapacityarealsoavailableviatheDCU;
seetheExpressionIFUmanual.Theminimumbatteryvoltagevaluefornormaloperationis
3.4V.
3.2.5BatteryDisposalInstructions
TheExpressionMRIPatientMonitoringSystemuseslithium‐polymerandlithium‐ion
batteriesthataresubjecttostrictdisposalregulationsforuserandenvironmentalsafety.
CAUTION:
Neverheatorthrowthebatteryintoafire.Heatingthebatterywill
damagethesafetycircuitry,whichcancauseruptureorignitionofthe
battery.
Batteriesmustbestoredinadryplace,atatemperaturebetween0°Cto
40°C.
TheExpressionMRIPatientMonitoringSystemusesrechargeable
batteriesthatcontainhazardousmaterial.Thesebatteriesmustbe
recycledordisposedofproperly.Refertodisposalguidelineslisted
below.Donotdisassembleorincineratethebattery.

Section3:SystemOverview
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3.2.5.1GuidelinesinEurope
TheEuropeanCommunity(EC)hasissuedtwodirectivesregardingbattery
disposal:91/157/EECand93/86/EEC.Eachmembercountryimplements
theseindependently.Thus,ineachcountrythemanufacturers,importers,
andusersareresponsiblefortheproperdisposalorrecyclingofbatteries.
Confirmproperdisposalrequirementswithyourhealthcarefacilityor
distributor.
3.2.5.2GuidelinesintheUnitedStates
TheU.S.FederalEnvironmentalProtectionAgency(EPA)hazardouswaste
regulations,asconveyedbytheResourcesConservationandRecoveryAct(RCRA),
neitherspecificallylistnorexemptlithiumbatteries.Theonlymetalofpossible
concerninthebatteryisthelithiummetalthatisnotlistedorcharacterizedasa
toxichazardouswaste.Significantamountofspentcellsandbatteriesthatare
untreatedandnotfullydischargedareconsideredasreactivehazardouswaste.
Thus,hazardouswasteofspentcellsandbatteriescanbedisposedaftertheyare
firstneutralizedthroughanapprovedsecondarytreatmentpriortodisposal(as
requiredbyU.S.LandBanRestrictionoftheHazardousandSolidWaste
Amendmentsof1984).Disposalofspentbatteriesmustbeperformedby
authorized,professionaldisposalcompany,whichhastheknowledgeinthe
requirementsoftheFederal,theStateandtheLocalauthoritiesregarding
hazardousmaterials,transportation,andwastedisposal.Confirmproperdisposal
requirementswithyourhealthcarefacility,distributor,and/orlocalEPAoffice.

Section3:SystemOverview
WARNING:THISPAGECONTAINSCOPYRIGHTEDMATERIALSTHATARECONFIDENTIALAND/ORPROPRIETARY.ANYRELEASEORDISTRIBUTION
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