GE HEALTHCARE MAC 5500 User manual

GEHealthcare
MAC®5500/MAC®5500HD
RestingECGAnalysisSystem
Operator'sManual
SoftwareVersion10
2046275-016B
MAC®5500/MAC®5500HDRestingECG
AnalysisSystem
English
©2010-2013GeneralElectricCompany.
AllRightsReserved.

PublicationInformation
TheinformationinthismanualonlyappliestoMAC®5500andMAC®5500HDsystemsoftwareversion10.Itdoesnotapplytoearlier
softwareversions.Duetocontinuingproductinnovation,specicationsinthismanualaresubjecttochangewithoutnotice.
MAC,MULTI-LINK,MUSE,MACTRODE,Ultra-Archivist,MobileLink,and12SLaretrademarksownedbyGEMedicalSystemsInformation
Technologies,Inc.,aGeneralElectricCompanygoingtomarketasGEHealthcare.Allothermarksarethepropertiesoftheirrespective
owners.
Thisproductcomplieswiththeregulatoryrequirementsconcerningmedicaldevicesfromthefollowingbodies:
Thedocumentpartnumberandrevisionareoneachpageofthedocument.Therevisionidentiesthedocument’supdatelevel.Therevision
historyofthisdocumentissummarizedinthefollowingtable.
RevisionHistory
RevisionPublicationDateDescription
A29October2010Initialreleaseofthedocument.
B28February2013Updatedthefollowingsections:
•SafetyMessages.
•SuppliesandAccessories.
•EquipmentSymbols
•ProductandPackagingLabels
•RelatedDocumentation
•ConnectingtheLANOption
•ConnectingtheModemOption
•SavingFilesinXMLFormat
•UpdatingSoftwarefromtheSDCard
•MiscellaneousSetup
•OrderManagerInterface
ToaccessotherGEHealthcareDiagnosticCardiologymanuals,gototheCommonDocumentationLibrary(CDL),locatedat
www.gehealthcare.com/documents,andclickCardiology.
2MAC®5500/MAC®5500HD2046275-016B
28February2013

Contents
1Introduction
ProductInformation....................................................................................9
IndicationsforUse....................................................................................9
PrescriptionDeviceStatement......................................................................9
RecordingECGsDuringDebrillation..............................................................9
AccuracyOftheInputSignalReproduction.....................................................10
ModulatingEffectsinDigitalSystems............................................................10
InstallationandConnection........................................................................10
SuppliesandAccessories...........................................................................10
EquipmentSymbols..................................................................................10
ProductandPackagingLabeling..................................................................12
EquipmentIdentication............................................................................14
RegulatoryandSafetyInformation...........................................................16
SafetyConventions..................................................................................16
SafetyMessages......................................................................................17
Classication..........................................................................................20
UnderwritersLaboratories,Inc....................................................................21
EMI/EMCRequirements.............................................................................21
LegalNotice...........................................................................................21
ResponsibilityoftheManufacturer................................................................22
ResponsibilityofthePurchaser/Customer.......................................................22
ServiceInformation...................................................................................22
ServiceRequirements...............................................................................22
AdditionalAssistance................................................................................22
ManualInformation..................................................................................22
ManualPurpose......................................................................................22
IntendedAudience...................................................................................23
DocumentConventions.............................................................................23
RelatedDocumentation.............................................................................24
Training.................................................................................................24
2SystemOverview
HardwareDescription...............................................................................25
FrontView.............................................................................................25
BackView..............................................................................................26
InternalView..........................................................................................26
BackPanel.............................................................................................27
Keyboard—StandardKeys.........................................................................28
Keyboard—ExerciseTestKeys(Option)..........................................................29
AcquisitionEquipment..............................................................................30
AcquisitionModule...................................................................................30
LeadwireLabels......................................................................................31
LeadwireAdapters...................................................................................32
ConnectingPeripherals.............................................................................32
ConnectingtheLANOption.........................................................................33
2046275-016BMAC®5500/MAC®5500HD3

ConnectingtheModemOption....................................................................33
ConnectingtheMobileLinkWirelessOption.....................................................33
ConnectingExternalExerciseDevices............................................................34
ConnectingtheAcquisitionDevice................................................................34
VerifyingCorrectOperation.........................................................................35
SoftwareOverview....................................................................................35
TestScreens...........................................................................................35
MainMenu.............................................................................................38
ReportLayout.........................................................................................41
EnteringData.........................................................................................43
3PreparingthePatient
PreparingthePatient'sSkin......................................................................46
ElectrodePlacement.................................................................................47
RestingECGPlacement.............................................................................47
ExerciseECGPlacement............................................................................52
4EnteringPatientInformation
ManuallyEnteringPatientInformation.....................................................56
ReadingaPatientCard(Option)................................................................56
ConnectingtheCardReader.......................................................................57
ReadingaPatientIDCard..........................................................................57
ScanningaBarCode(Option)...................................................................58
ConnectingtheBarCodeScanner................................................................58
ScanningtheBarCode..............................................................................58
EnteringOrders.........................................................................................59
ReceivingOrdersfromaMUSECVSystem(Option)............................................59
ManuallyEnteringOrders...........................................................................61
SelectingandCompletingOrders.................................................................61
5RecordinganECG
HookupAdvisor.........................................................................................63
StandardECGs..........................................................................................65
SignalAveragedECGs...............................................................................67
Master'sStepECGs...................................................................................68
6ExerciseStressTesting
StartingaStressTest................................................................................69
PretestPhase............................................................................................70
ExercisePhase...........................................................................................71
RecoveryPhase.........................................................................................73
4MAC®5500/MAC®5500HD2046275-016B

TestEndPhase..........................................................................................73
7EditingProtocols
ProtocolOverview.....................................................................................75
EditingorCreatingProtocols....................................................................77
8PrintingECGReports
PrintingAnotherReport............................................................................81
PrintingStoredECGs.................................................................................81
StoringPrintouts.......................................................................................82
9TransmittingECGs
TransmittingECGsviaModem..................................................................83
TransmittingECGsLocally........................................................................84
TransmittingECGsWirelessly...................................................................85
TransmittingECGsinXMLFormat.............................................................86
10ReceivingECGs
ReceivingECGsfromAnotherMACSystem...............................................87
ReceivingECGsviaModem.........................................................................87
ReceivingECGsLocally..............................................................................88
ReceivingECGsfromaMUSECVSystem...................................................88
11EditingECGs
EditingDemographicInformation............................................................91
EditingECGMeasurements.......................................................................92
EditingInterpretiveStatements................................................................93
12DeletingECGsandOrders
DeletingECGs............................................................................................95
DeletingOrders.........................................................................................96
13UsinganSDCard
SupportedSDCards..................................................................................99
PreparingtheSDCard.............................................................................100
2046275-016BMAC®5500/MAC®5500HD5

LockingandUnlockingtheSDCard.............................................................100
InsertingandEjectingtheSDCard..............................................................100
FormattingtheSDCard...........................................................................100
ManagingFilesontheSDCard...............................................................101
DisplayingStoredECGs............................................................................101
CopyingFilestotheSDCard.....................................................................101
RestoringFilesfromtheSDCard................................................................102
SavingFilesinXMLFormat.......................................................................102
UpdatingSoftwarefromtheSDCard......................................................103
14SystemSetup
SystemSetupHierarchy..........................................................................105
ProcessOverview....................................................................................107
SettingUpAutomaticTasks....................................................................108
SettingUpPowerUpFunction...................................................................108
SettingUpECGPreview...........................................................................108
SettingUpRestingECGReportPrinting........................................................109
SettingUpAutomaticECGStoring..............................................................109
SettingUpAutomaticECGTransmission.......................................................110
SettingUpSignalAveragedECGReportPrinting.............................................110
SettingUpACI-TIPIInterpretation...............................................................110
SettingUpSystemBasics........................................................................111
MiscellaneousSetup...............................................................................111
PatientQuestions...................................................................................113
ScreenColors........................................................................................116
Transmission........................................................................................116
NetworkSettings...................................................................................118
OptionActivation...................................................................................118
DateandTime......................................................................................120
Language............................................................................................120
PowerUpOptions..................................................................................121
OrderManagerInterface.........................................................................121
InputMethod........................................................................................122
SettingUpECGs......................................................................................123
ECGAcquisition.....................................................................................124
ECGAnalysis.........................................................................................125
PatientQuestions...................................................................................127
WriterSetup.........................................................................................127
ECGReports.........................................................................................128
AnalogOutputs.....................................................................................134
CTDataGuard......................................................................................135
CriticalValuesSetup...............................................................................136
SettingUpSignalAveragedECGs............................................................139
SettingUpExerciseTests........................................................................139
MiscellaneousSetup...............................................................................140
PatientQuestions...................................................................................140
WriterSetup.........................................................................................141
ExerciseReports....................................................................................141
Screen................................................................................................146
InputsandOutputs.................................................................................146
6MAC®5500/MAC®5500HD2046275-016B

Hi-Res......................................................................................................148
SettingUpaCardReader........................................................................149
AutomaticConguration..........................................................................150
ManualConguration.............................................................................150
SettingUpaBarCodeReader.................................................................151
AutomaticConguration..........................................................................151
ManualConguration.............................................................................151
SettingUpMaster'sStepTest.................................................................152
ManagingSystemSetup.........................................................................153
PrintingSystemSetup.............................................................................153
SavingSystemSetup..............................................................................153
RestoringSystemSetup...........................................................................153
AMaintenance
InspectingandCleaningtheMACSystem...............................................155
InspectingtheMACSystem......................................................................155
CleaningandDisinfectingExteriorSurfaces..................................................156
Cleaning,Disinfecting,andStoringECGCablesandLeadwires............................157
Cleaning,Disinfecting,andStoringHandheldDevices......................................159
PaperMaintenance.................................................................................161
SettingtheCorrectPaperSize...................................................................162
LoadingthePaper..................................................................................163
BatteryMaintenance..............................................................................163
ChargingtheBattery...............................................................................164
ConditioningtheBattery..........................................................................165
ReplacingtheBattery..............................................................................165
ReplacingLeadwireAdapters.................................................................166
BTroubleshooting
GeneralTroubleshootingGuidelines.......................................................169
VisualInspection.....................................................................................169
PerformanceProblems............................................................................169
UnacceptableNoiseLevels.......................................................................169
ACI-TIPIReportDoesNotPrint...................................................................170
ExternalDeviceDoesNotRecordBPReadings...............................................170
Treadmill/ErgometerDoesNotMove...........................................................170
SystemErrors..........................................................................................171
CReportFormats
NumericReports.....................................................................................173
AdditionalReports..................................................................................174
In-TestReports........................................................................................175
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ExerciseFinalReports.............................................................................176
ExerciseReportCodes.............................................................................177
DMaster'sStepData
Master'sStepTable.................................................................................179
ST-TChanges..........................................................................................182
ECreatingBarCodesandMagneticCards
ManualReaderConguration.................................................................183
AutomaticReaderConguration............................................................185
8MAC®5500/MAC®5500HD2046275-016B

1
Introduction
Thischapterprovidesinformationrequiredfortheproperuseoftheproductand
manual.Familiarizeyourselfwiththisinformationbeforeusingtheproduct.
ProductInformation
Thissectionprovidesageneraloverviewoftheproduct.Adetaileddescriptionofthe
productcanbefoundinChapter2,SystemOverview.
IndicationsforUse
TheMAC5500/5500HDECGAnalysisSystemisintendedtoacquire,analyze,display,
andrecordelectrocardiographicinformationfromadultandpediatricpopulations.
Basicsystemsdeliver3,6,12,or15leadECG’s,interpretiveanalysis,vectorloops,
andcanbeupgradedtoprovidesoftwareanalysisoptionssuchashighresolution
signalaveragingofQRSandPwaveportionsoftheelectrocardiogram.Transmission
andreceptionofECGdatatoandfromacentralECGcardiovascularinformation
systemisoptional.
TheMAC5500HDisintendedtobeusedunderthedirectsupervisionofalicensed
healthcarepractitioner,bytrainedoperatorsinahospitalormedicalprofessional’s
facility.
PrescriptionDeviceStatement
CAUTION:UnitedStatesfederallawrestrictsthisdevicetosalebyorontheorder
ofaphysician.
RecordingECGsDuringDebrillation
Thisequipmentisprotectedagainsttheeffectsofcardiacdebrillatordischarge
toensurerecovery,asrequiredbyteststandards.Thepatientsignalinputofthe
acquisitionmoduleisdebrillation-proof.Therefore,itisnotnecessarytoremove
theECGelectrodespriortodebrillation.
Whenusingstainlesssteelorsilverelectrodesadebrillatordischargecurrentmay
causetheelectrodestoretainaresidualchargecausingapolarizationordcoffset
voltage.ThiselectrodepolarizationwillblockacquisitionoftheECGsignal.Toavoid
thiscondition,usenon-polarizingelectrodes(whichwillnotformadcoffsetvoltage
whensubjectedtoadccurrent)suchassilver/silver-chloridetypesifthereisa
situationwherethereisalikelihoodthatadebrillationprocedurewillbenecessary.
2046275-016BMAC®5500/MAC®5500HD9

Introduction
Ifpolarizingelectrodesareused,werecommenddisconnectingtheleadwiresfrom
thepatientbeforedeliveringtheshock.
ElectrodedebrillationrecoveryistheabilityoftheelectrodetoallowtheECG
tracetoreturnafterdebrillation.Werecommendusingnon-polarizingdisposable
electrodeswithdebrillationrecoveryratingsasspeciedinAAMIEC124.2.2.4.(Refer
totheMAC3500/MAC5500HDSuppliesandAccessoriesReferenceManualforalist
ofapprovedelectrodes.)
AccuracyOftheInputSignalReproduction
•OverallSystemErrormeetsAAMIEC113.2.7.1.
OverallSystemErrorisbetweenorwithin+/–5%.
•FrequencyResponsemeetsAAMIEC113.2.7.2methodsAandD.
Frequencyresponseisbetweenorwithin+/-10%between0.67and40Hzand
between+0and-10%for20ms,1.5mVtriangularinput.
ModulatingEffectsinDigitalSystems
Thisdeviceusesdigitalsamplingtechniquesthatmayproducesomevariationin
amplitudesofQ,R,and/orSwavesfromoneheartbeattothenext,whichmay
beparticularlynoticeableinpediatricrecordings.Ifthisphenomenonisobserved,
theclinicianshouldbeawarethattheoriginofamplitudevariationsisnotentirely
physiologic.FormeasuringvoltagesofQ,R,andSwaves,itisadvisabletousetheQRS
complexeswiththelargestdeectionoftheparticularwaves.
InstallationandConnection
Iftheinstallationofthisequipment,intheUSA,willuse240Vratherthan120V,the
sourcemustbeacenter-tapped,240V,single-phasecircuit.
ContactGEHealthcareforinformationbeforeconnectinganydevicestothis
equipmentnotrecommendedinthismanual.
SuppliesandAccessories
Fororderinginformationandalistofsuppliesandaccessoriesthathavebeen
approvedbyGEHealthcareforusewiththisdevice,seetheMAC3500/MAC5500HD
RestingECGAnalysisSuppliesandAccessoriesReferenceManual.
EquipmentSymbols
Thefollowingsymbolsmayappearontheproductoritspackaging.
SymbolDescription
TypeBFequipment.Theacquisitionmoduleisprotectedfrom
debrillationshocks.
AlternatingCurrent
10MAC®5500/MAC®5500HD2046275-016B

Introduction
SymbolDescription
Equipotential
Chargethebattery.TheashingamberLEDnexttothissymbol
indicatesyoumustconnectthesystemtoACpowertorechargethe
battery.
LANportforconnectinganEthernetcablewithastandardRJ-45jack.
Internalmodemportforconnectingaphonelinewithastandard
RJ-11jack.
Wasteofelectricalandelectronicequipmentmustnotbedisposed
asunsortedmunicipalwasteandmustbecollectedseparately.
Pleasecontactanauthorizedrepresentativeofthemanufacturerfor
informationconcerningthedecommissioningofyourequipment.
Recyclethebattery.
Consulttheaccompanyingdocumentation.
Classiedwithrespecttoelectricshock,re,mechanical,andother
speciedhazardsonlyinaccordancewithapplicableULstandards.
Toreducetheriskofelectricshock,doNOTremovecover(orback).
Referservicingtoqualiedpersonnel.
Thisproductconsistsofdevicesthatmaycontainmercury,which
mustberecycledordisposedofinaccordancewithlocal,state,or
countrylaws.(Withinthissystem,thebacklightlampsinthemonitor
displaycontainmercury.)
Manufacturernameandaddress.
AuthorizedEuropeanrepresentative.
PCT.GOSTmarkingsymbolizingconformitywithapplicableRussian
Gosstandarttechnicalandsafetystandards.
USAOnly:Foruseonlyonorbyorderofaphysician.
CEMark—SymbolizesconformitywithapplicableEU(European
Union)directives.
2046275-016BMAC®5500/MAC®5500HD11

Introduction
ProductandPackagingLabeling
Thissectionidentiestheproductlabelsandtheirlocationsontheproductand
packaging.
12MAC®5500/MAC®5500HD2046275-016B

Introduction
Refertothepreviousillustrationsforthelocationsofthelabelsidentiedinthe
followingtable.
No.LabelDescription
1Locatedonthebottomofthedevice,thislabel
indicatesthedevicecontainsmercuryandmust
bedisposedofinaccordancewithstateandlocal
laws.
2Locatedonthecoverofthedevice,thislabel
identiestheproduct'smodelnumber.
3Locatedonthebackofthedevice,thislabel
containstheDisposalandGOSTlabels.Referto
“EquipmentSymbols”onpage10fordetailed
descriptionsofthesymbols.
4Locatedinsidethewritercompartment,thislabel
uniquelyidentiesthisunit.Referto“Product
Label”onpage15fordetailedinformation.
5Locatedonthebackofthedevice,thislabel
providesregulatoryandcautionaryinformation.
Referto“EquipmentSymbols”onpage10for
detaileddescriptionsofthesymbols.
6Locatedonthebackofthedevice,thislabel
identiesthedevice'selectricalratings.
7Locatedinsidethebatterycompartment,
thislabelprovidesinformationaboutthe
specicationsanddisposalofthebattery.Refer
to“EquipmentSymbols”onpage10fordetailed
descriptionsofthesymbols.
8Locatedonthefrontofthedevice,thislabel
indicatesthat,intheUSA,federallawrestricts
saleofthedevicetoorontheorderofaphysician.
9Locatedbelowthedisplay,thislabelindicatesthe
deviceusestheMarquette™12SL™ECGAnalysis
ProgramtoanalyzeandinterpretECGreadings.
2046275-016BMAC®5500/MAC®5500HD13

Introduction
No.LabelDescription
10Locatedtotherightofthedisplay,thislabel
instructstheuseronwheretoplaceleads.
11Locatedontherightsideofthedevice,thislabel
distinguishesbetweentheLANRJ-45portand
theinternalmodemRJ-11port.
12Locatedonthepackage,theshippinglabel
containsthefollowinginformation:
•Productdescription
•Salesordernumber
•Congurationnumber
•Modelnumber
•Serialnumber
•Storageconditions
•Regulatorycompliance
•CountryofOrigin
•ECRepresentativeinformation
EquipmentIdentication
EveryGEHealthcaredevicehasaproductlabelthatidentiestheproductname,part
number,manufacturinginformation,anduniqueserialnumber.Thisinformationis
requiredwhencontactingGEHealthcareforsupport.
14MAC®5500/MAC®5500HD2046275-016B

Introduction
ProductLabel
Theproductlabelislaidoutinthefollowingformat.Dependingontheproduct,the
labelmayvaryslightlyinformat,butitcontainsthesameinformation.
ProductLabelFormat
ItemDescription
1Productpartnumber
2Productdescription
3DateofmanufactureinYYYY-MMformat
4Manufacturernameandaddress
5Countryoforigin
6Productbarcode
7Unitserialnumber(See“SerialNumberFormat”onpage15formore
information.)
SerialNumberFormat
Eachdevicehasaserialnumberthatuniquelyidentiesthedeviceandprovides
importantinformationaboutthedevice.Theserialnumberformatisshowninthe
followingillustration:
SerialNumberFormat
ItemNameDescription
1ProductCodeAthree-lettercodethatuniquelyidentiesthe
productline.Referto“ProductCodes”onpage
16formoreinformation.
2YearManufacturedAtwo-digitcodeidentifyingtheyearthedevice
wasmanufactured.Valuesrangefrom00to99.
Forexample:00=2000,04=2004,05=2005
(andsoon).
2046275-016BMAC®5500/MAC®5500HD15

Introduction
SerialNumberFormat(cont'd.)
ItemNameDescription
3FiscalWeek
Manufactured
Atwo-digitcodeidentifyingtheweekthedevice
wasmanufactured.
Valuesrangefrom01to52.GEHealthcare'sscal
weekscorrespondtothecalendarweek.For
example,01=therstweekinJanuary.
4ProductSequenceAfour-digitnumberidentifyingtheorderinwhich
thisdevicewasmanufactured.Valuesrangefrom
000to9999.
5ManufacturingSiteAone-lettercodeidentifyingthesitewherethe
devicewasmanufactured.Forexample,F=
Milwaukee,N=Freiburg,P=Bangalore
6Miscellaneous
Characteristic
Forexample,P=thedeviceisaprototype,R=
thedevicewasrefurbished,U=thedevicewas
upgradedtomeetthespecicationsofanother
productcode.
ProductCodes
Theproductcodeidentiesspecicsystemplatforms.Youneedtheproductcode
beforeservicingorrequestingsupportforyourdevice.
Youcanidentifytheproductcodeusingthedevice’sserialnumber,whichcanbe
locatedinoneofthefollowingplaces:
•Ontheproductlabelattachedtothebaseofthedevice.
•OntheproductlabelprovidedwiththeapplicationCD.
•IntheapplicationonITsystems:
LaunchthesystemapplicationandclickHelp>Abouttoviewtheserialnumber.
Forinformationonlaunchingtheapplication,refertotheproduct'sserviceor
operator'smanual.
RegulatoryandSafetyInformation
Thissectionprovidesinformationaboutthesafeuseandregulatorycomplianceof
thissystem.Familiarizeyourselfwiththisinformation,andreadandunderstandall
instructionsbeforeattemptingtousethissystem.Thesystemsoftwareisconsidered
medicalsoftware.Assuch,itwasdesignedandmanufacturedtotheappropriate
medicalregulationsandcontrols.
NOTE:
Disregardingthesafetyinformationprovidedinthismanualisconsidered
abnormaluseofthissystemandcouldresultininjury,dataloss,oravoided
warranty.
SafetyConventions
AHazardisasourceofpotentialinjurytoaperson,property,orthesystem.
16MAC®5500/MAC®5500HD2046275-016B

Introduction
ThismanualusesthetermsDANGER,WARNING,CAUTION,andNOTICEtopointout
hazardsandtodesignateadegreeorlevelofseriousness.Familiarizeyourselfwith
thefollowingdenitionsandtheirsignicance.
DenitionsofSafetyConventions
Safety
Convention
Denition
DANGERIndicatesanimminenthazard,which,ifnotavoided,willresultindeath
orseriousinjury.
WARNINGIndicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultindeathorseriousinjury.
CAUTIONIndicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinmoderateorminorinjury.
NOTICEIndicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinthelossordestructionofpropertyordata.
SafetyMessages
Thefollowingmessagesapplytothesystemasawhole.Specicmessagesmayalso
beprovidedelsewhereinthemanual.
WARNING:
PATIENTMONITORING—Thisdevicedoesnotprovidealarmsandisnotintended
tobeusedaselectrocardiographicmonitoringequipment(vitalsignsphysiological
monitor).
Ifpatientmonitoringisrequired,useadevicethathasbeenqualiedforthatuse.
WARNING:
ACCIDENTALSPILLS—Ifliquidsenteradevice,takethedeviceoutofserviceand
haveitcheckedbyaservicetechnicianbeforeitisusedagain.
Toavoidelectricshockordevicemalfunction,liquidsmustnotbeallowedto
enterthedevice.
WARNING:
BATTERYOPERATION—Iftheintegrityoftheprotectiveearthconductorisin
doubt,operatetheunitfromitsbattery.
WARNING:
CABLES—Toavoidpossiblestrangulation,routeallcablesawayfromthepatient's
throat.
WARNING:
CONNECTIONTOMAINS—ThisisclassIequipment.
Themainsplugmustbeconnectedtoanappropriatepowersupply.
2046275-016BMAC®5500/MAC®5500HD17

Introduction
WARNING:
DEFIBRILLATORPRECAUTIONS—Donotcomeintocontactwithpatientsduring
debrillation.Otherwise,seriousinjuryordeathcouldresult.
PatientsignalinputslabeledwiththeCFandBFsymbolswithpaddlesare
protectedagainstdamageresultingfromdebrillationvoltages.
Toensureproperdebrillationprotection,useonlytherecommendedcablesand
leadwires.
Properplacementofdebrillatorpaddlesinrelationtotheelectrodesisrequiredto
ensuresuccessfuldebrillation.
WARNING:
ELECTRODES—Polarizingelectrods(stainlesssteelorsilverconstructed)may
causetheelectrodestoretainaresidualchargeafterdebrillation.Aresidual
chargewillblockacquisitionoftheECGsignal.
Wheneverpatientdebrillationisapossibility,usenon-polarizingelectrodes(silver
orsilverchlorideconstruction)forECGmonitoring.
WARNING:
MAGNETICANDELECTRICALINTERFERENCE—Magneticandelectricaleldsare
capableofinterferingwiththeproperperformanceofthedevice.
Forthisreason,makesurethatallexternaldevicesoperatedinthevicinityof
thedevicecomplywiththerelevantEMCrequirements.X-rayequipmentorMRI
devicesarepossiblesourcesofinterferenceastheymayemithigherlevelsof
electromagneticradiation.
WARNING:
EXPLOSIONHAZARD—DoNOTuseinthepresenceofammableanesthetics
vaporsorliquids.
WARNING:
INTERPRETATIONHAZARD—Computerizedinterpretationisonlysignicantwhen
usedinconjunctionwithclinicalndings.
Aqualiedphysicianmustoverreadallcomputer-generatedtracings.
WARNING:
OPERATOR—Medicaltechnicalequipmentsuchasthissystemmustbeused
onlybyqualiedandtrainedpersonnel.
WARNING:
SHOCKHAZARD—Improperuseofthisdevicepresentsashockhazard.Strictly
observethefollowingguidelines.Failuretodosomayendangerthelivesofthe
patient,user,andbystanders.
Whendisconnectingthedevicefromthepowerline,removetheplugfromthe
walloutletbeforedisconnectingthecablefromthedevice;otherwise,thereisa
riskofcomingintocontactwithlinevoltagebyinadvertentlyintroducingmetal
partsinthesocketsofthepowercord.
Devicesmaybeconnectedtootherdevicesortopartsofsystemsonlyafter
makingcertainthatthereisnodangertothepatient,operators,orenvironment
asaresult.StandardsIEC60601–1–1/EN60601–1–1mustbecompliedwithin
allcases.
18MAC®5500/MAC®5500HD2046275-016B

Introduction
WARNING:
SITEREQUIREMENTS—Improperplacementofthedeviceand/oraccessoriesmay
resultinahazardtothepatient,operator,orbystanders.
Donotroutecablesinawaythattheymaypresentastumblinghazard.
Connectorsforpatientcablesandleadwiresaredesignedtopreventaccidental
disconnection.
Fordevicesinstalledabovethepatient,adequateprecautionsmustbetakento
preventthemfromdroppingonthepatient.
WARNING:
TREADMILLS—Avoidrapidchangesintreadmillspeedand/orgradeduringa
stresstest.
CAUTION:
PROPERLEADWIRECONNECTION—Improperconnectionwillcauseinaccuracies
intheECG.
Traceeachindividualleadwirefromitsacquisitionmodulelabeltothecolored
connectorandthentotheproperelectrodetoensurethatitismatchedtothe
correctlabellocation.
CAUTION:
ACCESSORIES(SUPPLIES)—Partsandaccessoriesusedmustmeetthe
requirementsoftheapplicableIEC60601seriessafetystandardsandessential
performancestandards,and/orthesystemcongurationmustmeetthe
requirementsoftheIEC60601–1–1medicalelectricalsystemsstandards.
Toensurepatientsafety,useonlypartsandaccessoriesmanufacturedor
recommendedbyGEHealthcare.
CAUTION:
ACCESSORIES(EQUIPMENT)—Theuseofaccessoryequipmentthatdoesnot
complywiththeequivalentsafetyrequirementsofthisequipmentmayleadtoa
reducedlevelofsafetyoftheresultingsystem.
Considerationrelatingtothechoiceofequipmentshallinclude:
•Useoftheaccessoryinthepatientvicinity,and
•Evidencethatthesafetycerticationoftheaccessoryhasbeenperformed
inaccordancewiththeappropriateIEC60601–1and/orIEC60601–1–1
harmonizednationalstandard.
CAUTION:
BATTERYPOWER—Ifadeviceequippedwithanoptionalbatterypackwillnotbe
usedorconnectedtothepowerlineforaperiodofoversixmonths,removethe
battery.
CAUTION:
BEFOREINSTALLATION—Compatibilityiscriticaltosafeandeffectiveuseof
thisdevice.Pleasecontactyourlocalsalesorservicerepresentativepriorto
installationtoverifyequipmentcompatibility.
CAUTION:
DISPOSABLES—Disposabledevicesareintendedforsingleuseonly.Theyshould
notbereusedasperformancemaydegradeorcontaminationcouldoccur.
2046275-016BMAC®5500/MAC®5500HD19

Introduction
CAUTION:
DISPOSAL—Attheendofitsservicelife,theproductdescribedinthismanual,
aswellasitsaccessories,mustbedisposedofincompliancewithlocal,state,or
federalguidelinesregulatingthedisposalofsuchproducts.
Ifyouhavequestionsconcerningthedisposaloftheproduct,pleasecontactGE
Healthcareoritsrepresentative.
CAUTION:
EQUIPMENTDAMAGE—Devicesintendedforemergencyapplicationmustnotbe
exposedtolowtemperaturesduringstorageandtransporttoavoidmoisture
condensationattheapplicationsite.
Waituntilallmoisturehasvaporizedbeforeusingthedevice.
CAUTION:
ELECTRICSHOCK—Toreducetheriskofelectricshock,donotremovecover
orback.
Referservicingtoqualiedpersonnel.
CAUTION:
OPERATOR—Medicaltechnicalequipmentsuchasthiselectrocardiographsystem
mustonlybeusedbypersonswhohavereceivedadequatetrainingintheuseof
suchequipmentandwhoarecapableofapplyingitproperly.
CAUTION:
POWERREQUIREMENTS—Beforeconnectingthedevicetothepowerline,check
thatthevoltageandfrequencyratingsofthepowerlinearethesameasthose
indicatedontheunit'slabel.Ifthisisnotthecase,donotconnectthesystemto
thepowerlineuntilyouadjusttheunittomatchthepowersource.
IntheUSA,iftheinstallationofthisequipmentwilluse240Vinsteadof120V,the
sourcemustbecenter-tapped,240Vsingle-phasecircuit.
ThisequipmentissuitableforconnectiontopublicmainsasdenedinCISPR11.
CAUTION:
SERVICEABLEPARTS—Thisequipmentcontainsnouserserviceableparts.
Referservicingtoqualiedservicepersonnel.
CAUTION:
SUPERVISEDUSE—Thisequipmentisintendedforuseunderthedirectsupervision
ofalicensedhealthcarepractioner.
Classication
Thisdeviceisclassiedasfollows,inaccordancewithIEC60601–1:
CategoryClassication
TypeofprotectionagainstelectricshockClassIinternallypoweredequipment.
DegreeofprotectionagainstelectricshockTypeBFdebrillation-proofappliedpart.
Degreeofprotectionagainstharmfulingress
ofwater
Ordinaryequipment(enclosedequipment
withoutprotectionagainstingressofwater).
20MAC®5500/MAC®5500HD2046275-016B