GE HEALTHCARE MAC 5500 User manual

GEHealthcare

MAC

®

5500/MAC

®

5500HD

RestingECGAnalysisSystem

Operator'sManual

SoftwareVersion10

2046275-016B

MAC®5500/MAC®5500HDRestingECG

AnalysisSystem

English

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

Revision

PublicationDate

Description

A

29October2010Initialreleaseofthedocument.

B

28February2013Updatedthefollowingsections:

•SafetyMessages.

•SuppliesandAccessories.

•EquipmentSymbols

•ProductandPackagingLabels

•RelatedDocumentation

•ConnectingtheLANOption

•ConnectingtheModemOption

•SavingFilesinXMLFormat

•UpdatingSoftwarefromtheSDCard

•MiscellaneousSetup

•OrderManagerInterface

ToaccessotherGEHealthcareDiagnosticCardiologymanuals,gototheCommonDocumentationLibrary(CDL),locatedat

www.gehealthcare.com/documents,andclickCardiology.

2

MAC

®

5500/MAC

®

5500HD

2046275-016B

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

2046275-016B

MAC

®

5500/MAC

®

5500HD

3

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

4

MAC

®

5500/MAC

®

5500HD

2046275-016B

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

2046275-016B

MAC

®

5500/MAC

®

5500HD

5

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

6

MAC

®

5500/MAC

®

5500HD

2046275-016B

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

2046275-016B

MAC

®

5500/MAC

®

5500HD

7

ExerciseFinalReports.............................................................................176

ExerciseReportCodes.............................................................................177

DMaster'sStepData

Master'sStepTable.................................................................................179

ST-TChanges..........................................................................................182

ECreatingBarCodesandMagneticCards

ManualReaderConguration.................................................................183

AutomaticReaderConguration............................................................185

8

MAC

®

5500/MAC

®

5500HD

2046275-016B

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.

2046275-016B

MAC

®

5500/MAC

®

5500HD

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

Iftheinstallationofthisequipment,intheUSA,willuse240Vratherthan120V,the

sourcemustbeacenter-tapped,240V,single-phasecircuit.

ContactGEHealthcareforinformationbeforeconnectinganydevicestothis

equipmentnotrecommendedinthismanual.

SuppliesandAccessories

Fororderinginformationandalistofsuppliesandaccessoriesthathavebeen

approvedbyGEHealthcareforusewiththisdevice,seetheMAC3500/MAC5500HD

RestingECGAnalysisSuppliesandAccessoriesReferenceManual.

EquipmentSymbols

Thefollowingsymbolsmayappearontheproductoritspackaging.

Symbol

Description

TypeBFequipment.Theacquisitionmoduleisprotectedfrom

debrillationshocks.

AlternatingCurrent

10

MAC

®

5500/MAC

®

5500HD

2046275-016B

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.

2046275-016B

MAC

®

5500/MAC

®

5500HD

11

Introduction

ProductandPackagingLabeling

Thissectionidentiestheproductlabelsandtheirlocationsontheproductand

packaging.

12

MAC

®

5500/MAC

®

5500HD

2046275-016B

Introduction

Refertothepreviousillustrationsforthelocationsofthelabelsidentiedinthe

followingtable.

No.

Label

Description

1

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.

2046275-016B

MAC

®

5500/MAC

®

5500HD

13

Introduction

No.

Label

Description

10

Locatedtotherightofthedisplay,thislabel

instructstheuseronwheretoplaceleads.

11

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.

14

MAC

®

5500/MAC

®

5500HD

2046275-016B

Introduction

ProductLabel

Theproductlabelislaidoutinthefollowingformat.Dependingontheproduct,the

labelmayvaryslightlyinformat,butitcontainsthesameinformation.

ProductLabelFormat

Item

Description

1

Productpartnumber

2

Productdescription

3

DateofmanufactureinYYYY-MMformat

4

Manufacturernameandaddress

5

Countryoforigin

6

Productbarcode

7

Unitserialnumber(See“SerialNumberFormat”onpage15formore

information.)

SerialNumberFormat

Eachdevicehasaserialnumberthatuniquelyidentiesthedeviceandprovides

importantinformationaboutthedevice.Theserialnumberformatisshowninthe

followingillustration:

SerialNumberFormat

ItemName

Description

1

ProductCodeAthree-lettercodethatuniquelyidentiesthe

productline.Referto“ProductCodes”onpage

16formoreinformation.

2

YearManufacturedAtwo-digitcodeidentifyingtheyearthedevice

wasmanufactured.Valuesrangefrom00to99.

Forexample:00=2000,04=2004,05=2005

(andsoon).

2046275-016B

MAC

®

5500/MAC

®

5500HD

15

Introduction

SerialNumberFormat(cont'd.)

ItemName

Description

3

FiscalWeek

Manufactured

Atwo-digitcodeidentifyingtheweekthedevice

wasmanufactured.

Valuesrangefrom01to52.GEHealthcare'sscal

weekscorrespondtothecalendarweek.For

example,01=therstweekinJanuary.

4

ProductSequenceAfour-digitnumberidentifyingtheorderinwhich

thisdevicewasmanufactured.Valuesrangefrom

000to9999.

5

ManufacturingSiteAone-lettercodeidentifyingthesitewherethe

devicewasmanufactured.Forexample,F=

Milwaukee,N=Freiburg,P=Bangalore

6

Miscellaneous

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.

16

MAC

®

5500/MAC

®

5500HD

2046275-016B

Introduction

ThismanualusesthetermsDANGER,WARNING,CAUTION,andNOTICEtopointout

hazardsandtodesignateadegreeorlevelofseriousness.Familiarizeyourselfwith

thefollowingdenitionsandtheirsignicance.

DenitionsofSafetyConventions

Safety

Convention

Denition

DANGER

Indicatesanimminenthazard,which,ifnotavoided,willresultindeath

orseriousinjury.

WARNING

Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,

couldresultindeathorseriousinjury.

CAUTION

Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,

couldresultinmoderateorminorinjury.

NOTICE

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.

2046275-016B

MAC

®

5500/MAC

®

5500HD

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.

18

MAC

®

5500/MAC

®

5500HD

2046275-016B

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.

2046275-016B

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:

GE HEALTHCARE MAC 5500, MAC 5500 HD User manual

Other documents