GE HEALTHCARE MAC 5500, MAC 5500 HD Operator's Manual

GEHealthcare

MAC

®

5500/MAC

RestingECGAnalysisSystem
Operator'sManual

SoftwareVersion10
2046275-016B

®

5500HD

MAC®5500/MAC®5500HDRestingECG
AnalysisSystem
English
©2010-2013GeneralElectricCompany.
AllRightsReserved.

PublicationInformation

TheinformationinthismanualonlyappliestoMAC®5500andMAC®5500HDsystemsoftwareversion10.Itdoesnotapplytoearlier
softwareversions.Duetocontinuingproductinnovation,specicationsinthismanualaresubjecttochangewithoutnotice.

MAC,MUL TI-LINK,MUSE,MACTRODE,Ultra-Archivist,MobileLink,and12SLaretrademarksownedbyGEMedicalSystemsInformation
Technologies,Inc.,aGeneralElectricCompanygoingtomarketasGEHealthcare.Allothermarksarethepropertiesoftheirrespective
owners.

Thisproductcomplieswiththeregulatoryrequirementsconcerningmedicaldevicesfromthefollowingbodies:

Thedocumentpartnumberandrevisionareoneachpageofthedocument.Therevisionidentiesthedocument’supdatelevel.Therevision
historyofthisdocumentissummarizedinthefollowingtable.

RevisionHistory

Revision

A

B

PublicationDate

29October2010Initialreleaseofthedocument.

28February2013Updatedthefollowingsections:

Description

•SafetyMessages.

•SuppliesandAccessories.

•EquipmentSymbols

•ProductandPackagingLabels

•RelatedDocumentation

•ConnectingtheLANOption

•ConnectingtheModemOption

•SavingFilesinXMLFormat

•UpdatingSoftwarefromtheSDCard

•MiscellaneousSetup

•OrderManagerInterface

ToaccessotherGEHealthcareDiagnosticCardiologymanuals,gototheCommonDocumentationLibrary(CDL),locatedat

www.gehealthcare.com/documents,andclickCardiology.

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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

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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

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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

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ManagingFilesontheSDCard...............................................................101

UpdatingSoftwarefromtheSDCard......................................................103

14SystemSetup

SystemSetupHierarchy..........................................................................105

ProcessOverview....................................................................................107

SettingUpAutomaticTasks....................................................................108

LockingandUnlockingtheSDCard.............................................................100

InsertingandEjectingtheSDCard..............................................................100

FormattingtheSDCard...........................................................................100

DisplayingStoredECGs............................................................................101

CopyingFilestotheSDCard.....................................................................101

RestoringFilesfromtheSDCard................................................................102

SavingFilesinXMLFormat.......................................................................102

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

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AMaintenance

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

InspectingandCleaningtheMACSystem...............................................155

InspectingtheMACSystem......................................................................155

CleaningandDisinfectingExteriorSurfaces..................................................156

Cleaning,Disinfecting,andStoringECGCablesandLeadwires............................157

Cleaning,Disinfecting,andStoringHandheldDevices......................................159

PaperMaintenance.................................................................................161

SettingtheCorrectPaperSize...................................................................162

LoadingthePaper..................................................................................163

BTroubleshooting

CReportFormats

BatteryMaintenance..............................................................................163

ChargingtheBattery...............................................................................164

ConditioningtheBattery..........................................................................165

ReplacingtheBattery..............................................................................165

ReplacingLeadwireAdapters.................................................................166

GeneralTroubleshootingGuidelines.......................................................169

VisualInspection.....................................................................................169

PerformanceProblems............................................................................169

UnacceptableNoiseLevels.......................................................................169

ACI-TIPIReportDoesNotPrint...................................................................170

ExternalDeviceDoesNotRecordBPReadings...............................................170

Treadmill/ErgometerDoesNotMove...........................................................170

SystemErrors..........................................................................................171

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

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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.

1

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.

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9

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

SuppliesandAccessories

EquipmentSymbols

Iftheinstallationofthisequipment,intheUSA,willuse240Vratherthan120V,the
sourcemustbeacenter-tapped,240V,single-phasecircuit.

ContactGEHealthcareforinformationbeforeconnectinganydevicestothis
equipmentnotrecommendedinthismanual.

Fororderinginformationandalistofsuppliesandaccessoriesthathavebeen
approvedbyGEHealthcareforusewiththisdevice,seetheMAC3500/MAC5500HD
RestingECGAnalysisSuppliesandAccessoriesReferenceManual.

Thefollowingsymbolsmayappearontheproductoritspackaging.

Symbol

Description

TypeBFequipment.Theacquisitionmoduleisprotectedfrom
debrillationshocks.

AlternatingCurrent

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Introduction

Symbol

Description

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.

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Introduction

ProductandPackagingLabeling

Thissectionidentiestheproductlabelsandtheirlocationsontheproductand
packaging.

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Refertothepreviousillustrationsforthelocationsofthelabelsidentiedinthe
followingtable.

Introduction

No.

Label

1

Description

Locatedonthebottomofthedevice,thislabel
indicatesthedevicecontainsmercuryandmust
bedisposedofinaccordancewithstateandlocal
laws.

2

Locatedonthecoverofthedevice,thislabel
identiestheproduct'smodelnumber.

3

Locatedonthebackofthedevice,thislabel
containstheDisposalandGOSTlabels.Referto

“EquipmentSymbols”onpage10fordetailed

descriptionsofthesymbols.

4

Locatedinsidethewritercompartment,thislabel
uniquelyidentiesthisunit.Referto“Product

Label”onpage15fordetailedinformation.

5

Locatedonthebackofthedevice,thislabel
providesregulatoryandcautionaryinformation.
Referto“EquipmentSymbols”onpage10for
detaileddescriptionsofthesymbols.

6

Locatedonthebackofthedevice,thislabel
identiesthedevice'selectricalratings.

7

Locatedinsidethebatterycompartment,
thislabelprovidesinformationaboutthe
specicationsanddisposalofthebattery.Refer
to“EquipmentSymbols”onpage10fordetailed
descriptionsofthesymbols.

8

Locatedonthefrontofthedevice,thislabel
indicatesthat,intheUSA,federallawrestricts
saleofthedevicetoorontheorderofaphysician.

9

Locatedbelowthedisplay,thislabelindicatesthe
deviceusestheMarquette™12SL™ECGAnalysis
ProgramtoanalyzeandinterpretECGreadings.

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Introduction

No.

10

11

Label

Description

Locatedtotherightofthedisplay,thislabel
instructstheuseronwheretoplaceleads.

Locatedontherightsideofthedevice,thislabel
distinguishesbetweentheLANRJ-45portand
theinternalmodemRJ-11port.

12

Locatedonthepackage,theshippinglabel
containsthefollowinginformation:

•Productdescription

•Salesordernumber

•Congurationnumber

•Modelnumber

•Serialnumber

•Storageconditions

•Regulatorycompliance

•CountryofOrigin

•ECRepresentativeinformation

EquipmentIdentication

EveryGEHealthcaredevicehasaproductlabelthatidentiestheproductname,part
number,manufacturinginformation,anduniqueserialnumber .Thisinformationis
requiredwhencontactingGEHealthcareforsupport.

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ProductLabel

Introduction

Theproductlabelislaidoutinthefollowingformat.Dependingontheproduct,the
labelmayvaryslightlyinformat,butitcontainsthesameinformation.

ProductLabelFormat

SerialNumberFormat

Item

1

2

3

4

5

6

7

Description

Productpartnumber

Productdescription

DateofmanufactureinYYYY-MMformat

Manufacturernameandaddress

Countryoforigin

Productbarcode

Unitserialnumber(See“SerialNumberFormat”onpage15formore
information.)

Eachdevicehasaserialnumberthatuniquelyidentiesthedeviceandprovides
importantinformationaboutthedevice.Theserialnumberformatisshowninthe
followingillustration:

SerialNumberFormat

ItemName

1

2

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ProductCodeAthree-lettercodethatuniquelyidentiesthe

YearManufacturedAtwo-digitcodeidentifyingtheyearthedevice

MAC®5500/MAC®5500HD

Description

productline.Referto“ProductCodes”onpage

16formoreinformation.

wasmanufactured.Valuesrangefrom00to99.
Forexample:00=2000,04=2004,05=2005
(andsoon).

15

Introduction

SerialNumberFormat(cont'd.)

ProductCodes

ItemName

3

4

5

6

FiscalWeek
Manufactured

ProductSequenceAfour-digitnumberidentifyingtheorderinwhich

ManufacturingSiteAone-lettercodeidentifyingthesitewherethe

Miscellaneous
Characteristic

Description

Atwo-digitcodeidentifyingtheweekthedevice
wasmanufactured.
Valuesrangefrom01to52.GEHealthcare'sscal
weekscorrespondtothecalendarweek.For
example,01=therstweekinJanuary.

thisdevicewasmanufactured.Valuesrangefrom
000to9999.

devicewasmanufactured.Forexample,F=
Milwaukee,N=Freiburg,P=Bangalore

Forexample,P=thedeviceisaprototype,R=
thedevicewasrefurbished,U=thedevicewas
upgradedtomeetthespecicationsofanother
productcode.

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.

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ThismanualusesthetermsDANGER,WARNING,CAUTION,andNOTICEtopointout
hazardsandtodesignateadegreeorlevelofseriousness.Familiarizeyourselfwith
thefollowingdenitionsandtheirsignicance.

DenitionsofSafetyConventions

Introduction

Safety
Convention

DANGER

WARNING

CAUTION

NOTICE

Denition

Indicatesanimminenthazard,which,ifnotavoided,willresultindeath
orseriousinjury.

Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultindeathorseriousinjury.

Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinmoderateorminorinjury.

Indicatesapotentialhazardorunsafepractice,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.

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17

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.

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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.

Introduction

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.

2046275-016B

MAC®5500/MAC®5500HD

19

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:

Category

TypeofprotectionagainstelectricshockClassIinternallypoweredequipment.

Classication

DegreeofprotectionagainstelectricshockTypeBFdebrillation-proofappliedpart.

Degreeofprotectionagainstharmfulingress
ofwater

20

MAC®5500/MAC®5500HD

Ordinaryequipment(enclosedequipment
withoutprotectionagainstingressofwater).

2046275-016B

Introduction

Category

Degreeofsafetyofapplicationinthe
presenceofaammableanestheticmixture
withairorwithoxygenornitrousoxide

Method(s)ofsterilizationordisinfection
recommendedbythemanufacturer

Modeofoperation

UnderwritersLaboratories,Inc.

MedicalEquipment

Withrespecttoelectricshock,re,andmechanicalhazardsonlyin
accordancewithapplicableULstandards.

EMI/EMCRequirements

Thedeviceorsystemislabeledundertheoriginalequipmentmanufacturerslabel(for
example,USAFCC47CFR15,CEEUEMC2004/108/EC),anddeemedsufcientby
GEHealthcaretobeincompliancewithEN/IEC60601-1-2whenusedaccordingto
thedeviceorsystem’sintendeduse.GEHealthcare-suppliedhardwaremeetsthe
applicablecountryrequirements.

Classication

Equipmentnotsuitablefouseinthepresence
ofaammableanestheticmixturewithairor
withoxygenornitrousoxide.

Notapplicable.

Continuousoperation.

Classication

ClassAThedeviceorsystemissuitableforuseinallestablishmentsotherthan

Description

domesticandthosedirectlyconnectedtothepubliclow-voltagepower
supplynetworkthatsuppliesbuildingsusedfordomesticpurposes.
Mainspowershouldbeatypicalcommercialorhospitalenvironment.

NOTE:

Complianceprovidesreasonableprotectionagainstradio-frequencyinterference.
However,thereisnoguaranteethatinterferencewillnotoccurinaparticular
installation.Youcantellwhetherthisdeviceorsystemiscausinginterferenceby
turningitoff.Iftheinterferencestops,itwasprobablycausedbythedeviceor
system.

Formoreinformationregardingtheinstallationofthisproductincompliancewithits
electromagneticcompatibility,refertotheservicemanual.

LegalNotice

OurequipmentcontainsseveraleldsthatcanbelledinbeforeperforminganECG.
Someoftheseeldsmustbelledinbeforeperforminganexam;someareoptional
andthereforelefttotheusertoassesswhethertheyareneededtoperformthe
exam.AeldRaceisoneoftheseoptionalelds.Racehasbeenacknowledgedby
themedicalprofessionasusefultoanalyzesomepathologies.Youshouldbeaware
that,insomejurisdictions,theprocessingofdatarevealinganindividual’sracialorigin
issubjecttolegalrequirements,suchasobtainingthepatient’spriorconsent.Ifyou
electtocollectthistypeofdata,itisyourresponsibilitytoensurethatyoucomply
withallapplicablelegalrequirements.

2046275-016B

MAC®5500/MAC®5500HD

21

Introduction

ResponsibilityoftheManufacturer

GEHealthcareisresponsibleforthesafety,reliability,andperformanceofhardware
suppliedbyGEHealthcareonlyifthefollowingconditionsaremet:

•Assemblyoperations,extensions,readjustments,modications,orrepairsare
performedbypersonsauthorizedbyGEHealthcare.

•Theelectricalinstallationoftheroomwherethedeviceisusedcomplieswiththe
requirementsoftheappropriatelocal,state,andothergovernmentregulations.

•Theequipmentisusedinaccordancewiththeinstructionsforuse.

ResponsibilityofthePurchaser/Customer

Thecustomerisresponsibleforprovidingappropriatedesks,chairs,electricalwall
outlets,networkconnections,andanalogphonelines,andforlocatinganyofthe
systemcomponentsdescribedinthismanualincompliancewithalllocal,state,and
nationalcodes.

ServiceInformation

ServiceRequirements

AdditionalAssistance

ManualInformation

Thissectionprovidesinformationpertainingtothemaintenanceandservicingofthe
system.FamiliarizeyourselfwiththisinformationbeforerequestingservicefromGE
Healthcareoritsauthorizedrepresentatives.

Failureonthepartoftheresponsibleindividual,hospital,orinstitutionusingthis
equipmenttoimplementasatisfactorymaintenanceschedulemaycauseundue
equipmentfailureandpossiblesafetyhazards.

Regularmaintenance,irrespectiveofusage,isessentialtoensurethatthecomponents
ofthissystemarealwaysfunctionalwhenrequired.

GEHealthcaremaintainsatrainedstaffofapplicationandtechnicalexpertstoanswer
questionsandrespondtoissuesandproblemsthatmayariseduringtheinstallation,
maintenance,anduseofthissystem.

ContactyourlocalGEHealthcarerepresentativetorequestadditionalassistance.

Thissectionprovidesinformationforthecorrectuseofthismanual.

ManualPurpose

Thismanualprovidesinformationnecessaryforthecongurationandsafeoperation
ofthisequipmentinaccordancewithitsfunctionandintendeduse.Itisnotintended
asareplacementfor,butasupplementto,thoroughproducttraining.Keepitwith
theequipmentatalltimes.AdditionalmanualsmaybeorderedbycontactingGE
Healthcare.

22

MAC®5500/MAC®5500HD

2046275-016B

IntendedAudience

DocumentConventions

TypographicalConventions

Introduction

Refertotheservicemanualfortechnicalinformationrelatedtothemaintenanceand
repairoftheequipment.

Thismanualisintendedtobeusedbytheperson(s)responsiblefortheconguration
andoperationoftheequipment.Itisexpectedthattheuserofthismanualwill
completethoroughproducttrainingaswellasreadandunderstandallinstructions
inthismanualbeforeattemptingtousetheproduct.

RequesttrainingfromGEHealthcare,ifneeded.

Thismanualusesthefollowingconventions.

ConventionDescription

BoldTextIndicateskeysonthekeyboard,texttoenter,orhardwareitemssuchas

buttonsorswitchesontheequipment.

Italicized-Bold

Text

CTRL+ESC

<space>

Enter

>

Indicatessoftwaretermsthatidentifymenuitems,buttonsoroptionsin
variouswindows.

Indicatesakeyboardoperation.Aplus(+)signbetweenthenamesoftwo
keysindicatesthatwhileholdingtherstkey,youshouldpressandrelease
thesecondkey.Forexample,PressCTRL+ESCmeanstopressandholdthe
CTRLkeyandthenpressandreleasetheESCkey.

Indicatesthatyoumustpressthespacebar.Wheninstructionsaregiven
fortypingaprecisetextstringwithoneormorespaces,thepointwhere
youmustpressthespacebarisindicatedas<space>.Thisensuresthat
thecorrectnumberofspacesisinsertedinthecorrectpositionswithin
theliteraltextstring.Thepurposeofthe<>bracketsistodistinguishthe
commandfromtheliteraltextwithinthestring.

IndicatesthatyoumustpresstheEnterorReturnkeyonthekeyboard.Do
nottypeEnter.

Thegreaterthansymbol,orrightanglebracket,isaconcisemethodto
indicateasequenceofmenuselections.

Forexample,thestatement“Fromthemainmenu,selectSystem>Setup>
OptionstoopentheOptionActivationwindow”replacesthefollowing:

1.Fromthemainmenu,selectSystemtoopentheSystemmenu.

2.FromtheSystemmenu,selectSetuptoopentheSetupmenu.

3.FromtheSetupmenu,selectOptionstoopentheOptionActivation

window.

Illustrations

Allillustrationsinthemanualareprovidedasexamplesonly.Dependingonsystem
conguration,screensinthemanualmaydifferfromthescreensonyoursystem.

Allpatientnamesanddataarectitious.Anysimilaritytoactualpersonsis
coincidental.

2046275-016B

MAC®5500/MAC®5500HD

23

Introduction

Notes

RelatedDocumentation

Notesprovideapplicationtipsoradditionalinformationthat,whileuseful,arenot
essentialtothecorrectoperationofthesystem.Theyarecalledoutfromthebody
textthroughaagwordandindentation,asfollows:

NOTE:

ThetiporadditionalinformationisindentedbelowtheNOTEagword.

Thefollowingdocumentsarereferencedinthismanualandprovideadditional
informationthatmaybehelpfulintheinstallation,conguration,maintenance,and
useofthisproduct.

PartNumberTitle

2036070-006

2046275-017

2020299-021

2025521-001

2020299-025

2046275-223

Marquette™12SL™ECGAnalysisProgramPhysician'sGuide

MAC™5500/MAC™5500HDRestingECGAnalysisSystemField
ServiceManual

MobileLink™WirelessCommunicationsInstallationManual

KISS™MultileadOperator’sManual

LANOptionforMAC™RestingECGSystemsInstallationand
TroubleshootingGuide

MAC3500/MAC5500HDRestingECGAnalysisSuppliesand
AccessoriesReferenceManual

Training

Thismanualisintendedasasupplementto,notasubstitutefor,thoroughproduct
training.Ifyouhavenotreceivedtrainingontheuseofthesystem,youshouldrequest
trainingassistancefromGEHealthcare.

Toseeavailabletraining,gototheGEHealthcaretrainingWeb
site(www.gehealthcare.com/training).SelectEducation>Product
Education-Technical>DiagnosticCardiology.

Formoreself-pacedcourseofferings,tools,andreferenceguidesyou
maynduseful,pleasevisittheGEHealthcareEducationStoreat

www.gehealthcare.com/educationstore.

24

MAC®5500/MAC®5500HD

2046275-016B

SystemOverview

Thischapterdescribesthedevice'shardwarecomponents,softwarescreen
components,reportlayout,andbasicnavigationanddataentry.Familiarizeyourself
withthisinformationbeforeusingthedevice.

HardwareDescription

ThissectionidentiesthekeycomponentsoftheMACsystemhardware.Familiarize
yourselfwiththesecomponents,theirlocation,andtheirusebeforeattempting
tousetheequipment.

FrontView

2

Name

1

2

2046275-016B

DisplayScreenViewthewaveformandtextdata.

ModemPortConnecttoatelephoneline.

MAC®5500/MAC®5500HD

Description

25

SystemOverview

Name

3LANPort

4

KeyboardControlsthesystemandentersdata.

Description

ConnecttoaLANcable.LEDsprovideinformation
aboutconnectionstatus.

•ThegreenLEDindicatesagoodEthernetlink.

•TheamberLEDashestoindicatenetworktrafc.

BackView

InternalView

Name

1

2

3

4

5

BackpanelconnectorsConnecttoperipherals.

SecuredatacardslotInsertasecureddata(SD)cardforexternalstorage.

GreenACPower

InternalaccessbuttonOpensthesystemtochangepaperorbattery.

AmberbatterylightIndicatesthebatteryischarging.

Description

IndicatesthesystemisconnectedtoACpower.

26

MAC®5500/MAC®5500HD

2046275-016B

SystemOverview

BackPanel

Name

1

2

3

4Papertray

5

Battery

WriterdoorProvidesaccesstothewriter ,papertray,andbattery.

Acquisitionmodule
connector

PapersizeselectorAdjuststhepapertrayforSTD(USLetter)orA4paper

Description

SuppliespowerwhenunitisnotconnectedtoAC
power.Rechargethebatterywhenthebatteryicon
asheson-screen.

Connectstheunittoanacquisitionmodule.

ContainsthepaperusedtoprintECGs.

sizes.

WARNING:

CURRENTLEAKAGE—Keepcurrentleakagewithinacceptablelimitswhen
connectingauxiliaryequipmenttothisdevice.

Totalsystemcurrentleakagemustnotexceed100microamperes.

Name

1

21ConnectstoaGEKISSpump.

A

Description

Connectstoanoptionalcardreader,barcodereader,
orPS/2keyboardforenteringpatientinformation.

Whenusingtheexerciseoption,connectstoaT2000
treadmillorexternalbloodpressuredevice.

NOTE:

Ergolinebicycleergometersmustbeconnected
toboththisportandtheANA/TTLport.

3

4

2

ANA/TTL

Connectstoalocaltransmissioncable,serialline,
modem,orclientbridge(wirelessoption).

ConnectstoadevicerequiringanalogdataoraTTL
trigger.

Whenusingtheexerciseoption,connectstoan
analogtreadmill,ergometercable,orTTLtrigger.

NOTE:

Ergolinebicycleergometersmustbeconnected
toboththisportandport1.

5EXT.VID.

2046275-016B

MAC®5500/MAC®5500HD

Connectstoanexternalvideodisplay.

27

SystemOverview

Name

6

7

8

9

IR

CardslotHousesasystemcardforexternaldatastorageor

GroundlugConnectstonon-groundedperipheraldevicesto

MainACPower

Keyboard—StandardKeys

Description

ExchangesECGdatawithaMACsystemorMUSECV
systemviainfraredtransmission.

NOTE:

Dependingontheageofyoursystem,infrared
transmissionmaynotbesupported.

toupdatesoftware.

ensureequipotential.

ConnectsthesystemtoanACpowersupplyvia
powercable.

Name

1

2

3

4

5

28

FunctionkeysSelectsscreenmenufunctions.

PowerbuttonPowersthesystemonandoff.

DeletekeyErasestypedcharacters.

CopykeyPrintsanadditional(copy)ECGreport.

ECGkeyAcquiresa12SLrestingECG,includingmeasurements

MAC®5500/MAC®5500HD

Description

andinterpretation.

2046275-016B

SystemOverview

Name

6

7

8

9

10

11

12

13

14

RhythmkeyPrintscontinuousECGdata,whichcannotbestored

StopkeyStopsthewriterfromprinting.

ArrowpadMovesthecursorleft,right,up,ordown.Pressing

ReturnkeyEntersinformationintothesystem.

InformationkeyProvidesadditionaluserinformation.

SpacebarAddsaspacebetweentypedcharactersorhighlights

OptionkeyUsedtocreatespecialcharactersonnon-English

EsckeyReturnstothepreviousmenu.

ShiftkeyCreatescapitalletters.Pressshift+ptotypeP.

Keyboard—ExerciseTestKeys(Option)

Description

ortransmitted.

thecenterbuttonselectsthehighlightedmenuor
screenitem.

screenitems.

keyboards.

Name

1

2

2046275-016B

Pretest

Exercise

MAC®5500/MAC®5500HD

Description

Advancestothenextstagewithinthecurrentpretest
phase.

Advancestheexercisetesttotheexercisephaseor
tothenextstagewithinthecurrentexercisephase.

29

SystemOverview

Name

3Recovery

4

5

6

7

8

9

10

11Comment

12

TestendEndsthetestandstartsthetestendphase.

SpeedWAdjuststhebeltspeedontreadmillsorloadon

GradeAdjuststhegradeofthetreadmill.PressGradeá ááto

Start/STOPtmill

RecallPrintsa10–seconddelayedrecallreport.

12ldPrintsa12–leadreportwith10secondsofacquired

MediansPrintsamediansreport.

EnterBP

Description

Advancestheexercisetesttotherecoveryphaseor
tothenextstagewithinthecurrentrecoveryphase.

ergometers.PressSpeedW—todecreasethespeed
orload.PressSpeedW+toincreasethespeedor
load.

increasethegrade.pressGradeâ ââtodecreasethe
grade.

Startsorstopsthetreadmillduringthetest.Press

Starttmilltomanuallystartthetreadmill.Press
STOPtmilltomanuallystopthetreadmill.

NOTE:

Intheeventofanemergency,pressandholdthe
STOPtmillkeytostopthetreadmillquickly.

data.

Allowsyoutoentercommentsaboutthetest.
Commentsareprintedonmanyofthenalreports.

Allowsyoutoenterbloodpressurereadingsorto
triggerareadingfromanexternaldevice.

AcquisitionEquipment

AcquisitionModule

30

ThissectionprovidesanoverviewoftheexternalequipmentconnectedtotheMAC
systemfortheacquisitionofECGdata.Familiarizeyourselfwiththesecomponents
beforeattemptingtoacquireECGdata.

WARNING:

BURNPROTECTION—UseofacquisitionmodulesotherthantheCAM-14orCAM
HDacquisitionmodulescouldresultinhigh-frequencyburns.

Toensuredebrillationprotectionandprotectionagainstseriousinjury,useonly
theCAM-14orCAMHDacquisitionmoduleswiththisequipment.

MAC®5500/MAC®5500HD

2046275-016B