GE HEALTHCARE MAC 2000 User manual

GEHealthcare
MAC™2000
ECGAnalysisSystem
Operator'sManual
2053535-002RevisionK
English
©2013-2017GeneralElectricCompany.
AllRightsReserved.

PublicationInformation
TheinformationinthismanualappliesonlytoMAC™2000.Thisappliestosoftwareversion1.1andnottoearliersoftwareversions.Dueto
continuingproductinnovation,specicationsinthismanualaresubjecttochangewithoutnotice.
MUSE,MAC,CASE/CardioSoft/CS,12SL,andEMRaretrademarksownedbyGEMedicalSystemsInformationTechnologies,Inc.,aGeneral
ElectricCompanygoingtomarketasGEHealthcare.Allothertrademarkscontainedhereinarethepropertyoftheirrespectiveowners.
ThisprogramusestheSOA4DDPWSCore(CDPWStoolkit)library,©2004–2010SchneiderElectricSA,licensedundertheBSDLicense.
PartofthesoftwareembeddedinthisproductisgSOAPsoftware.PortionscreatedbygSOAPareCopyright©2001-2004RobertA.van
Engelen,GeniviaInc.AllRightsReserved.
THESOFTWAREINTHISPRODUCTWASINPARTPROVIDEDBYGENIVIAINCANDANYEXPRESSORIMPLIEDWARRANTIES,INCLUDING,BUT
NOTLIMITEDTO,THEIMPLIEDWARRANTIESOFMERCHANTABILITYANDFITNESSFORAPARTICULARPURPOSEAREDISCLAIMED.INNOEVENT
SHALLTHEAUTHORBELIABLEFORANYDIRECT,INDIRECT,INCIDENTAL,SPECIAL,EXEMPLARY,ORCONSEQUENTIALDAMAGES(INCLUDING,
BUTNOTLIMITEDTO,PROCUREMENTOFSUBSTITUTEGOODSORSERVICES;LOSSOFUSE,DATA,ORPROFITS;ORBUSINESSINTERRUPTION)
HOWEVERCAUSEDANDONANYTHEORYOFLIABILITY,WHETHERINCONTRACT,STRICTLIABILITY,ORTORT(INCLUDINGNEGLIGENCEOR
OTHERWISE)ARISINGINANYWAYOUTOFTHEUSEOFTHISSOFTWARE,EVENIFADVISEDOFTHEPOSSIBILITYOFSUCHDAMAGE."
ThisproductincludessoftwaredevelopedbytheOpenSSLProjectforuseintheOpenSSLToolkit(http://www.openssl.org/).Thisproduct
includescryptographicsoftwarewrittenbyEricYoung([e-mail]).ThisproductincludessoftwarewrittenbyTimHudson
([e-mail]).
Thisproductcomplieswiththerequirementsconcerningmedicaldevicesfromthefollowingregulatorybodies.Formoreinformationabout
compliance,refertotheRegulatoryandSafetyGuideforthisproduct.
Thedocumentpartnumberandrevisionareoneachpageofthedocument.Therevisionidentiesthedocument’supdatelevel.Therevision
historyofthisdocumentissummarizedinthefollowingtable.
RevisionDateComments
A17October2012InternalRelease
B24April2013CustomerRelease
C15July2013RevisionsperSPRHCSDM00204349relatingtoIEC3rdEditionlabeling,and
SPRHCSDM00222909.
D27May2015UpdatedforMAC2000V1.1SP3.
E26July2016Updatedformaintenanceprojects.UDIsymboladdedtotheSymboltable,and
theFCCstatement
F25November2016UpdatedforMAC2000SilexWWprojects.
G14April2017Addedthenewaccessoriesandsuppliesmanual.
Removethesuppliesandaccessoriescleaninginformation.
H8June2017Updatethefollowing:
•AddedFullDisclosureinstruction
•AddedAutoQueryinstruction
•Updatedsomeproductspecication
J31August2017Updatethenewcapabilitybatteryrelatedinformation.
K30September2017Updatetheembeddedwirelessmodulerelatedinformation.
ToaccessotherGEHealthcareDiagnosticCardiologydocuments,gototheCommonDocumentationLibrary(CDL),locatedat
www.gehealthcare.com/documents,andclickCardiology.
ToaccessOriginalEquipmentManufacturer(OEM)documents,gotothedevicemanufacturer'swebsite.
2MAC™20002053535-002K
30September2017

Contents
1Introduction
IntendedUserofthisProduct.....................................................................9
IndicationsforUse......................................................................................9
Contraindications.....................................................................................10
PrescriptionDeviceStatement.................................................................10
RegulatoryandSafetyInformation...........................................................10
SafetyConventions..................................................................................10
SafetyHazards........................................................................................11
ClassicationofMedicalDevice...................................................................13
CerticationInformation............................................................................13
RecordingECGsDuringDebrillation.............................................................14
AccuracyofInputSignalReproduction...........................................................14
ModulatingEffectsinDigitalSystems............................................................14
EMI/EMC/RFSafetyInformation...................................................................14
Biocompatibility.......................................................................................15
LegalNotice...........................................................................................15
SuppliesandAccessories...........................................................................16
ResponsibilityoftheManufacturer................................................................16
ResponsibilityofthePurchaser/Customer.......................................................16
ProductandPackagingInformation..............................................................16
EquipmentIdentication...........................................................................25
ProductLabel.........................................................................................25
SerialNumberFormat...............................................................................25
DeviceAddressLabelandRatingPlate...........................................................26
ProductCodes........................................................................................27
ServiceInformation...................................................................................27
ServiceRequirements...............................................................................27
WarrantyInformation...............................................................................27
AdditionalAssistance................................................................................27
ManualInformation..................................................................................28
ManualPurpose......................................................................................28
DocumentConventions.............................................................................28
RelatedDocuments...................................................................................29
2ProductOverview
ProductDescription..................................................................................31
ProductSpecications..............................................................................31
HardwareDescriptions..............................................................................31
OptionalSoftwareFeatures........................................................................37
2053535-002KMAC™20003

UsingtheSystem.....................................................................................37
NavigatingtheUserInterface...................................................................40
RestingECGPowerUpMode.......................................................................41
ArrhythmiaPowerUpMode........................................................................41
MainScreenPowerUpMode.......................................................................42
StressECGPowerUpMode.........................................................................42
OrderManagerPowerUpMode...................................................................43
3SettingUptheEquipment
InsertingtheBattery.................................................................................45
ConnectingtheACPower..........................................................................45
ConnectingthePatientCable...................................................................46
ConnectingtheBarcodeReader...............................................................48
ConnectingtheLANOption.......................................................................48
ConnectingtoLAN...................................................................................48
ConnectingtoWLAN.................................................................................49
ConnectingtheUSBWirelessOption........................................................49
ConnectingExternalDevices(StressOption)............................................49
ConnectinganInternalModem................................................................49
InsertingthePaper...................................................................................50
TurningontheSystem..............................................................................50
ConguringtheDevice..............................................................................50
TestingtheDevice.....................................................................................50
4PreparingthePatient
PreparingthePatient’sSkin......................................................................51
ElectrodePlacement.................................................................................52
RestingECGPlacement.............................................................................52
Stress12–LeadPlacement..........................................................................55
5EnteringPatientInformation
EnteringPatientInformationWithanInternalKeypadorExternal
Keyboard...................................................................................................57
EnteringPatientInformationwithaBarcodeReader...............................58
ScanningtheBarcode...............................................................................58
AutomaticQuery.......................................................................................59
4MAC™20002053535-002K

6OrderManager
CommunicationMedia..............................................................................63
SimpleOrders............................................................................................63
AdvancedOrderManager.........................................................................64
DownloadingOrders.................................................................................64
SelectingandCompletingOrders.................................................................65
UsingtheOrderManagerInterface..........................................................66
DeletingOrders.......................................................................................66
7RecordingaRestingECG
HookupAdvisor.........................................................................................70
RestingECGs.............................................................................................72
RecordingaRestingECG............................................................................72
ECGOptions...........................................................................................73
Post-AcquisitionOptions............................................................................75
FullDisclosure...........................................................................................77
GeneratingaFullDisclosureECGReport.........................................................77
FullDisclosureReportSetup........................................................................79
SpecialConsiderations..............................................................................80
RecordingECGsofPacemakerPatients..........................................................80
RecordingECGsDuringDebrillation.............................................................81
GeneratingaRhythmReport(ManualRecording)....................................81
8ArrhythmiaModeRecording
RecordinginArrhythmiaMode.................................................................83
RecordingArrhythmiaECGs........................................................................83
ArrhythmiaRecordingOptions.....................................................................84
Printing.....................................................................................................85
PrintinganArrhythmiaReport.....................................................................85
ArrhythmiaPrintingOptions........................................................................86
ArrhythmiaCodes.....................................................................................86
9RRAnalysis
RRAnalysisMode......................................................................................89
RRAnalysisSetup.....................................................................................89
AcquiringaRecordingforanRRAnalysisReport...............................................93
OutputOptions........................................................................................93
10StressTesting
StressModeInterface...............................................................................96
StressTestInformationBar.........................................................................96
StressTestKeys.......................................................................................98
2053535-002KMAC™20005

StressOptions.........................................................................................98
ConductingStressTests..........................................................................100
ConductingaStressTestwithaTreadmillorErgometer....................................100
ConductingaStressTestwithaMaster’sStepDevice......................................102
11ManagingInternalStorage
ImportingRecords..................................................................................105
PrintingtheFileManagerDirectory........................................................106
FindingRecords.......................................................................................107
EditingPatientData................................................................................107
PreviewingRecords.................................................................................108
DeletingRecords.....................................................................................109
PrintingRecords......................................................................................109
TransmittingRecords..............................................................................109
ExportingRecords...................................................................................111
SettingUpExportOptions........................................................................111
ExportingRecords..................................................................................111
12SystemConguration
BasicSetup..............................................................................................113
RestingECGSetup...................................................................................118
ArrhythmiaSetup...................................................................................130
StressECGSetup.....................................................................................133
StressECGSettings.................................................................................133
EditingStressProtocols...........................................................................137
CommunicationSetup.............................................................................140
CountrySetup.........................................................................................153
PrintSetupReport...................................................................................154
PatientSetup...........................................................................................155
UserSetup...............................................................................................161
SelectSetup.............................................................................................163
ImportSetup...........................................................................................164
6MAC™20002053535-002K

ExportSetup............................................................................................165
OptionsSetup..........................................................................................165
ServiceSetup...........................................................................................167
Date/TimeSetup.....................................................................................168
OrderManagerSetup..............................................................................168
RRAnalysisSetup....................................................................................169
PDFFileNamingConvention...................................................................169
DefaultNamingConvention......................................................................169
CustomizingtheNamingConvention...........................................................170
RetrievingYourPassword.......................................................................171
ExportingtheAuditTrail.........................................................................171
13Maintenance
EquipmentCleaningandStorage...........................................................173
InspectingtheEquipment.........................................................................173
CleaningtheDevice................................................................................174
Cleaning,DisinfectingandStoringLeadwiresandReusable
Electrodes...............................................................................................175
ReplacingLeadwireAdapters.................................................................175
PaperMaintenance.................................................................................175
ReplacingPaper....................................................................................176
AdjustingtheTrayforPaperSize................................................................177
RemovingthePaperPack.........................................................................178
StoringThermalPaper.............................................................................179
BatteryMaintenance..............................................................................179
ReplacingtheBattery..............................................................................179
ConditioningtheBatteryPack...................................................................180
BatteryStatusIndicator...........................................................................181
SuppliesandAccessories........................................................................181
14Troubleshooting
GeneralTroubleshootingTips.................................................................183
FrequentlyAskedQuestions(FAQ)..........................................................184
EquipmentProblems...............................................................................184
SystemDoesNotPowerUp......................................................................184
ECGDataContainsNoise.........................................................................185
ExternalStressEquipmentdoesnotMove.....................................................185
PaperJams..........................................................................................186
2053535-002KMAC™20007

Import/Export/SaveErrors......................................................................186
SDCardNotPresent...............................................................................186
CannotImportorTransmitRecordsviaModem..............................................186
CannotTransmitRecordsviaLAN...............................................................187
CannotTransmitRecordsViaWLAN(SilexWirelessBridge)...............................187
CannotTransmitRecordsviaUSBWireless...................................................188
CannotTransmitRecordsviaEmbeddedWirelessModule.................................188
CannotExporttoSharedDirectories............................................................189
Acquisition/PrinterErrorMessages........................................................189
ReportErrors...........................................................................................190
ACI-TIPIStatementisnotIncludedonReport.................................................190
SystemErrors..........................................................................................190
ACreatingBarcodes
SettingUpthePatientDataScheme.......................................................195
ConguringtheBarcodeReader.............................................................196
ConguringtheBarcodeReaderManually....................................................196
ConguringtheBarcodeReaderAutomatically..............................................197
BMaster’sStepData
Master'sStepTable.................................................................................199
ST-TChanges..........................................................................................202
CTechnicalSpecications
SystemSpecications.............................................................................203
SilexWirelessBridge...............................................................................210
DStatementforMAC2000SilexWirelessBridge
FCCStatement........................................................................................213
ICStatement...........................................................................................214
ComplieswithIMDAStandards...............................................................214
EStatementforMAC2000EmbeddedWirelessModule
8MAC™20002053535-002K

1
Introduction
ThisdocumentdescribestheMAC™2000ECGAnalysisSystem,alsoreferredto
asthe“product”,“system”,or“device”.Thedocumentisintendedtobeusedby
clinicalprofessionalswhouse,maintain,and/ortroubleshootthesystem.Clinical
professionalsareexpectedtohaveaworkingknowledgeofappropriatemedical
procedures,practices,andterminologyusedinthetreatmentofpatients.
Thischapterprovidesgeneralinformationrequiredfortheproperuseofthesystem
andthismanual.Familiarizeyourselfwiththisinformationbeforeusingthesystem.
IntendedUserofthisProduct
TheMAC™2000ECGAnalysisSystemisaportableECGacquisition,analysis,and
recordingsystemthatisintendedforusebytrainedoperatorsinahospitalormedical
professional’sfacilityenvironment,aswellasusedinclinics,physicianofces,
outreachcenters,orwhereverECGtestingisperformed.
IndicationsforUse
TheMAC™2000ECGAnalysisSystemisaportabledeviceintendedtobeusedby
orunderthedirectsupervisionofalicensedhealthcarepractitionerusingsurface
electrodestoacquire,analyze,display,andrecordinformationforadultandpediatric
populationsinahospital,medicalprofessional’sfacility,clinics,physician’sofceor
outreachcenters.
NOTE:
Pediatricpopulationsaredenedaspatientsbetweentheagesof0and15years.
TheMAC™2000ECGAnalysisSystemprovidesthefollowingmodesofoperation:
•RestingECGmode
•Arrhythmiamode
•Exercisemodeforexercisestresstesting(optional)
•RRanalysismodeforRRintervalanalysis(optional)
Thebasicsystemprints6or12leadsofECGandisupgradeabletoprovidesoftware
optionssuchas12-leadECGmeasurementandinterpretiveanalysis.
2053535-002KMAC™20009

Introduction
Arrhythmiadetectionisprovidedfortheconvenienceofautomaticdocumentation.
TransmissionandreceptionofECGdatatoandfromacentralECGcardiovascular
informationsystemisoptional.
Contraindications
Thissystemisnotintendedforuseinthefollowingmanner:
•Duringpatienttransport
•Withhigh-frequencysurgicalunits
•Asanintra-cardiacapplication
•Asavitalsignsphysiologicalmonitor
PrescriptionDeviceStatement
CAUTION:
UnitedStatesfederallawrestrictsthisdevicetosalebyorontheorderofa
physician.
RegulatoryandSafetyInformation
Thissectionprovidesinformationaboutthesafeuseandregulatorycomplianceof
thissystem.Familiarizeyourselfwiththisinformation,andreadandunderstandall
instructionsbeforeattemptingtousethissystem.Thesystemsoftwareisconsidered
medicalsoftware.Assuch,itwasdesignedandmanufacturedtotheappropriate
medicalregulationsandcontrols.
NOTE:
Disregardingthesafetyinformationprovidedinthismanualisconsidered
abnormaluseofthissystemandcouldresultininjury,dataloss,oravoided
warranty.
SafetyConventions
AHazardisasourceofpotentialinjurytoaperson,property,orthesystem.
ThismanualusesthetermsDANGER,WARNING,CAUTION,andNOTICEtopointout
hazardsandtodesignateadegreeorlevelofseriousness.Familiarizeyourselfwith
thefollowingdenitionsandtheirsignicance.
DenitionsofSafetyConventions
Safety
Convention
Denition
DANGERIndicatesanimminenthazard,which,ifnotavoided,willresultindeath
orseriousinjury.
WARNINGIndicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultindeathorseriousinjury.
10MAC™20002053535-002K

Introduction
DenitionsofSafetyConventions(cont'd.)
Safety
Convention
Denition
CAUTIONIndicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinmoderateorminorinjury.
NOTICEIndicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinthelossordestructionofpropertyordata.
SafetyHazards
Thefollowingmessagesapplytothesystemasawhole.Specicmessagesmayalso
beprovidedelsewhereinthemanual.
WARNING:
EQUIPMENTMALFUNCTION—Anyattemptbyunauthorizedpersonneltoservice
thedevicecouldresultinequipmentmalfunctionandvoidthewarranty.
Thisequipmentcontainsnouser-serviceableparts.Referservicingtoauthorized
servicepersonnel.
WARNING:
PATIENTINJURY–STRANGULATION—Cablespresentapossiblestrangulation
hazard.
Toavoidpossiblestrangulation,routeallcablesawayfromthepatient’sthroat.
Useashortversionofcableforpediatricpatients.
WARNING:
PERSONALINJURY–STUMBLINGHAZARD—Patientscanbecomeentangledinthe
cablesandleadwiresconnectedtothedevice,whichcouldcausethepatient
tostumbleortrip.
Routecablesandleadwiresinawaytoavoidcreatingastumblinghazard:keep
themofftheoor,androuteleadwiresawayfromthepatient’slegsandthe
healthcareprovider’sworkarea.
WARNING:
MAGNETICANDELECTRICALINTERFERENCE—Magneticandelectriceldscan
interferewiththeacquisitionofECGreadings.
Makesurethatallperipheralcomponentsoperatedinthevicinityofthedevice
complywiththerelevantEMCrequirements.X-rayequipment,MRIdevices,
radiosystems(cellularphones)andsoforth,arepossiblesourcesofinterference
becausetheymayemithigherlevelsofelectromagneticradiation.Verifythe
performanceofthesystembeforeuse.
WARNING:
EXPLOSIONHAZARD—Usingthisdeviceinthepresenceofanestheticvaporsor
liquidscancauseexplosions.
Donotusethisdeviceinthepresenceofanestheticvaporsorliquids.Onlypersons
withadequatetraininginthecorrectuseofthisdevicemayusethisdevice.
2053535-002KMAC™200011

Introduction
WARNING:
EQUIPMENTFAILURE—Polarizingelectrodes(stainlesssteelorsilverconstructed)
maycausetheelectrodestoretainaresidualchargeafterdebrillation.Aresidual
chargeblocksacquisitionoftheECGsignal.
Wheneverpatientdebrillationisapossibility,usenon-polarizingelectrodes
(silver-silverchlorideconstruction)forECGmonitoring.
WARNING:
PERSONALINJURY—Contactwithpatientsduringdebrillationcancauseserious
injuryordeath.
Donotcontactpatientsduringdebrillation.Patientsignalinputslabeledwiththe
CFandBFsymbolswithpaddlesareprotectedagainstdamageresultingfrom
debrillationvoltages.
Toensureproperdebrillatorprotection,useonlyGEHealthcarerecommended
cablesandleadwires.Properplacementofdebrillatorpaddlesinrelationtothe
electrodesisrequiredtoensuresuccessfuldebrillation.
WARNING:
INTERPRETATIONHAZARD—ResultsoftheautomatedQTanalysisarenot
consideredadiagnosis.
Aqualiedphysicianorcardiologistmustreviewandconrmthemeasurements
andwaveformsrecordedbythesystem.Itshouldbeusedonlyasanadjunctto
theclinicalhistory,symptoms,andresultsofothertests.
WARNING:
INTERPRETATIONHAZARD—Computerizedinterpretationisonlysignicantwhen
usedinconjunctionwithclinicalndings.
Aqualiedphysicianmustoverreadallcomputer-generatedtracings.
WARNING:
POORSIGNALQUALITY—Improperskinpreparationcancausepoorsignalquality
duringtheECGrecording.
Carefulskinpreparationisthekeytoaninterference-freeECG.
WARNING:
IMPROPERUSE—Thisisaprescriptivedevice.
Thisequipmentisintendedforusebyorunderthedirectsupervisionofalicensed
healthcarepractitioner.
WARNING:
EXPLOSIONHAZARD—Batteriesmayexplodeinres
Donotdisposeofthebatterybyre.Followlocalenvironmentalguidelines
concerningdisposalandrecycling.
WARNING:
ELECTRICSHOCKHAZARD/SYSTEMMALFUNCTIONLiquidsinsideadevicecan
causeelectricshockorsystemmalfunction.
Donotallowliquidstoenterthedevice.Ifliquidsenterthedevice,turnitoffand
informyourservicetechnician.Donotusethedeviceuntilitischeckedbya
servicetechnician.
12MAC™20002053535-002K

Introduction
WARNING:
ELECTRICSHOCK—Improperconnectionofthisequipmentmaycauseelectric
shock.
Toavoidriskofelectricshock,thisequipmentmustonlybeconnectedtoasupply
mainswithprotectiveearth.
NOTE:
Followtheinstructionsprovided.Donotpositionequipmentinawaythatmakesit
difculttodisconnectthedevicewhenusinganappliancecoupler,mainsplug,or
otherseparableplugasameansofisolation.
ClassicationofMedicalDevice
Thedeviceisclassiedasfollows,accordingtoIEC60601-1:
MedicalDeviceClassications
CategoryClassication
Typeofprotectionagainstelectrical
shockClassIinternallypoweredequipment
Degreeofprotectionagainstelectrical
shockTypeCFdebrillation-proofappliedpart
DegreeofprotectionagainstsolidsTheIPcodeforthisdeviceisIP20.
Protectedagainstsolidforeignobjectswitha
diameterof12.5mmandgreater
Theobjectprobe,asphere12.5mmdiameter,
shallnotfullypenetrate.Thejointedtestnger
12mmdiameter,80mmlength,shallhave
adequateclearancefromhazardousparts.
Degreeofprotectionagainstharmful
ingressofliquids(IP20)TheIPcodeforthisdeviceisIP20.
Non-protected
Thisdeviceisordinaryequipment(enclosed
equipmentwithoutprotectionagainstingress
ofliquids)
Degreeofsafetyofapplicationinthe
presenceofammableanesthetic
mixturewithairorwithoxygenorwith
nitrousoxide
Equipmentisnotsuitableforuseinthepresence
ofaammableanestheticmixturewithairor
withoxygenorwithnitrousoxide
Method(s)ofsterilizationordisinfection
recommendedbythemanufacturerNotapplicable
ModeofoperationContinuousoperation
CerticationInformation
MedicalEquipment
Withrespecttoelectricshock,re,andmechanicalhazardsonlyin
accordancewithUL60601–1,andCAN/CSAC22.2NO.601.1.
2053535-002KMAC™200013

Introduction
RecordingECGsDuringDebrillation
Thisequipmentisprotectedagainsttheeffectsofcardiacdebrillatordischarge
toensurerecovery,asrequiredbyteststandards.Thepatientsignalinputofthe
acquisitionmoduleisdebrillation-proof.Therefore,itisnotnecessarytoremove
theECGelectrodespriortodebrillation.
Whenusingstainlesssteelorsilverelectrodes,adebrillatordischargecurrentmay
causetheelectrodestoretainaresidualchargecausingapolarizationorDCoffset
voltage.ThiselectrodepolarizationblocksacquisitionoftheECGsignal.Toavoidthis
condition,ifthereisasituationwhereadebrillationproceduremightbenecessary,
usenon-polarizingelectrodes(whichdonotformaDCoffsetvoltagewhensubjected
toaDCcurrent)suchassilver/silver-chloridetypes.
Ifyouusepolarizingelectrodes,GEHealthcarerecommendsdisconnectingthe
leadwiresfromthepatientbeforedeliveringtheshock.
ElectrodedebrillationrecoveryistheabilityoftheelectrodetoallowtheECGtraceto
returnafterdebrillation.GEHealthcarerecommendsusingnon-polarizingdisposable
electrodeswithdebrillationrecoveryratingsasspeciedinAAMIEC125.2.2.4.AAMI
EC12requiresthatthepolarizationpotentialofanelectrodepairdoesnotexceed100
mV5secondsafteradebrillationdischarge.
Refertothesuppliesandaccessoriesreferenceguideforthissystemforalistof
approvedelectrodes.
AccuracyofInputSignalReproduction
•OverallSystemErrormeetsAAMIEC113.2.7.1requirements.OverallSystemErroris
betweenorwithin±5%or±40µV,whicheverisgreater.
•FrequencyResponsemeetsAAMIEC113.2.7.2requirements,usingtestingmethods
AandD.Frequencyresponseisbetweenorwithin±10%between0.67and40Hz
andbetween+0and-10%for20ms,1.5mVtriangularinput.
ModulatingEffectsinDigitalSystems
Thisdeviceusesdigitalsamplingtechniquesthatmayproducesomevariationin
amplitudesofQ,R,and/orSwavesfromoneheartbeattothenext,whichmaybe
particularlynoticeableinpediatricrecordings.Ifyouobservethisphenomenon,
beawarethattheoriginofamplitudevariationsisnotentirelyphysiological.For
measuringvoltagesofQ,R,andSwaves,GEHealthcareadvisesusingtheQRS
complexeswiththelargestdeectionoftheparticularwaves.
EMI/EMC/RFSafetyInformation
Thissystemisdesignedandtestedtocomplywithapplicableregulationsregarding
EMCandmustbeinstalledandputintoserviceaccordingtotheEMCinformation
statedintheElectromagneticCompatibilityappendixoftheServiceand/orOperator’s
manual.ChangesormodicationstothissystemnotexpresslyapprovedbyGE
HealthcarecouldcauseEMCissueswiththisorotherequipment.Mainspowershould
beastandardcommercialorhospitalenvironment.
14MAC™20002053535-002K

Introduction
Beforeinstallingorusingthedeviceorsystem,beawareoftheproximityofknownRF
sources,suchasthefollowing:
•RadioandTVstations
•PortableandmobileRFcommunicationdevices(cellphones,two-wayradios)
•X-ray,CT,orMRIdevices
Thesedevicesarealsopossiblesourcesofinterferenceastheymayemithigher
levelsofelectromagneticradiation.
WARNING:
EQUIPMENTMALFUNCTION/INTERFERENCE—Useofportablephonesorother
radiofrequency(RF)emittingequipmentnearthesystemmaycauseunexpected
oradverseoperation.
Donotuseportablephonesorotherelectronicequipmentthatmayemitradio
frequency(RF)nearthissystem.
WARNING:
EQUIPMENTMALFUNCTION/INTERFERENCE—Donotusetheequipmentorsystem
adjacentto,orstackedwith,otherequipment.
Ifadjacentorstackeduseisnecessary,testtheequipmentorsystemtoverify
normaloperationinthecongurationinwhichyouareusingit.
WARNING:
ACCESSORIES/COMPONENTS—Addingaccessoriesorcomponents,ormodifying
themedicaldeviceorsystem,mayresultinincreasedEMISSIONSordecreased
IMMUNITYofthedeviceorsystem.
UsethefollowingresourcesformoreinformationonEMI/EMCandRFconcerns:
•TheSuppliesandAccessoriesReferenceGuideforyoursystem
•QualiedGEHealthcareorapprovedthird-partypersonnel
•TheElectromagneticCompatibilityappendixinyoursystemserviceoroperator’s
manual
NOTE:
Complianceprovidesreasonableprotectionagainstradio-frequencyinterference.
However,thereisnoguaranteethatinterferencewillnotoccurinaparticular
installation.Youcantellwhetherthisdeviceorsystemiscausinginterferenceby
turningitoff.Iftheinterferencestops,itwasmostlikelycausedbythedeviceor
system.
Biocompatibility
Thepartsofthesystemdescribedinthismanualthatcomeintocontactwiththe
patientduringtheintendeduse,includingallaccessories,fulllthebiocompatibility
requirementsoftheapplicablestandards.Ifyouhavequestionsinthismatter,contact
yourGEHealthcarerepresentative.
LegalNotice
GEHealthcaresoftwarecontainsseveraleldsthatcanbelledinbeforeperforming
anECG.Someoftheseeldsarerequired,whileothersareoptionalandlefttothe
usertoassesswhethertheyareneededtoperformtheexam.TheeldRaceisone
2053535-002KMAC™200015

Introduction
oftheseoptionalelds.Racehasbeenacknowledgedbythemedicalprofessionas
usefultoanalyzesomepathologies.Youshouldbeawarethat,insomejurisdictions,
theprocessingofdatarevealinganindividual'sracialoriginissubjecttolegal
requirements,suchasobtainingthepatient'spriorconsent.Ifyouelecttocollectthis
typeofdata,itisyourresponsibilitytoensurethatyoucomplywithallapplicable
legalrequirements.
SuppliesandAccessories
YoushoulduseonlysuppliesandaccessoriesthatGEHealthcarerecommends.For
alistofrecommendations,refertothesuppliesandaccessoriesreferenceguide
forthissystem
ContactGEHealthcarebeforeusinganythingthatisnotrecommendedforthissystem.
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.
ProductandPackagingInformation
Thissectionidentiesthefollowing:
•Hardwarelabelsandtheirlocationsonpage17
•SymbolDescriptionsonpage18
16MAC™20002053535-002K

Introduction
HardwareLabelLocations
LabelDescriptionsonHardwareandPackaging
ItemLabelLocationDescription
1BackofthedeviceProductLabel
Identiesthisdevice.See
“ProductLabel”onpage25
foradescriptionofthelabel
contents.
2BackofthedeviceDeviceAddressLabeland
RatingPlate
Itprovidesregulatoryand
cautionaryinformation.See
“DeviceAddressLabeland
RatingPlate”onpage26for
anexplanationofthelabel.
3Bottomcoverofthe
deviceTheOptionCodelabel. Usetheoptioncodestosetup
thepurchasedoptionsinyour
system.
See“OptionsSetup”onpage
165foranexplanationofthe
OptionCodes.
4Ontheshipping
packageEnvironmentalsymbols requiredforshipping.
2053535-002KMAC™200017

Introduction
LabelDescriptionsonHardwareandPackaging(cont'd.)
ItemLabelLocationDescription
5Ontheshipping
packageBatteryShippingLabel. FRAGILE—LithiumIon
batteriescancausereif
damaged.
6Ontheshipping
packageTheshippinglabel.
SymbolDescriptions
Thefollowingtabledescribessymbolsoriconsthatmaybeonthedeviceorits
packaging.Notallofthesymbolsdenedinthetableapplytoyourdeviceorits
packaging.
Symbolsareusedtoconveywarnings,cautions,prohibitions,mandatoryactions,
orinformation.Anysymbolonyourdeviceorpackagingwithmarkingsincolor
indicatestheremaybeadanger,warning,ormandatoryaction.Anysymbolonyour
deviceorpackagingthatisinblackandwhiteprovidesadditionalinformationormay
indicateacaution.Familiaritywiththesesymbolsassistsintheuseanddisposal
oftheequipment.
Forequipmentsymbolsnotshown,refertotheoriginalequipmentmanufacturer
(OEM)manuals.
SymbolDescriptions
SymbolDescription
CatalogorOrderablePartNumber
Indicatesthemanufacturer'scatalogorpartnumber.
SerialNumber
Indicatesthemanufacturer'sserialnumber.
BatchCodeorLotNumber
Indicatesthemanufacturer'sbatchcodeorlotnumber.
DateofManufacture(Year-Month)
Indicatestheoriginalmanufacturedateforthisdevice.
Manufacturer
Indicatesthenameandaddressforthemanufacturerofthisdevice.It
mayalsoincludethedateitwasmanufactured.
AuthorizedRepresentativeintheEuropeanCommunity
Indicatesthenameandaddressoftheauthorizedrepresentativeinthe
EuropeanCommunityforthisdevice.
UniqueDeviceIdenticationisauniquemarkingforidenticationof
themedicaldevice.
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Introduction
SymbolDescriptions(cont'd.)
SymbolDescription
RxOnly
USFederallawrestrictsthisdevicetosalebyorontheorderofa
physician.
12SL
IndicatesthedeviceusestheMarquette™12SLECGAnalysisProgram
toanalyzeandinterpretECGreadings.
IPxyIPCode(IngressProtectionRating)
Classiesandratesthedegreeofprotectionprovidedagainstthe
intrusionofsolidobjects(suchasbodypartslikehandsandngers,
dust,accidentalcontact),andliquids.
Therstnumeral(x)representsthedegreeofprotectionagainstthe
ingressofsolidobjects.
Thesecondnumeral(y)representsthedegreeofprotectionagainstthe
ingressofliquids.
ForproductswithanIPxyrating,seetheClassicationofMedicalDevice
inthischapterforadescriptionofthatrating.Notallproductshave
anIPxyrating.
ClassIIEquipment
Identiesequipmentthatmeetsthesafetyrequirementsspeciedfor
classIIequipmentbyIEC60601–1.
Thisdevicewasdesignedsothatitdoesnotrequireasafetyconnection
toelectricalearth(USground).Nosinglefailureresultsindangerous
voltagebecomingexposedandcausinganelectricshock.Thisis
achievedwithoutrelyingonanearthedmetalcasing.
ConsultInstructionsforUse
Consulttheoperatinginstructions.
Debrillation-proofTypeBFAppliedPart
Identiesadebrillation-prooftypeBFappliedpartonmedical
equipmentthatcomplieswithIEC60601–1.
Thisdevicemeetstherequirementsforprotectionagainstelectric
shockforanearth-free(oating)appliedpart(oneintendedforcontact
withpatients).
Debrillation-proofTypeCFAppliedPart
Identiesadebrillation-prooftypeCFappliedpartonmedical
equipmentthatcomplieswithIEC60601–1.
Thisdevicemeetstherequirementsforprotectionagainstelectric
shockforanearth-free(oating)appliedpart(oneintendedforcontact
withpatients)forcardiacapplication.
NoUser–orField-serviceableParts
Donotopenordisassemblethedeviceforanyreason.
ProtectiveEarth(ground)
Identiestheterminalofaprotectiveearth(ground)electrodeorany
terminalthatisintendedforconnectiontoanexternalconductorfor
protectionagainstelectricshockincaseofafault.
2053535-002KMAC™200019

Introduction
SymbolDescriptions(cont'd.)
SymbolDescription
Non-ionizingElectromagneticRadiation
Indicatesthattheequipmentemitselevated,potentiallyhazardous,
levelsofnon-ionizingradiation(electromagneticenergy)fordiagnosis
ortreatment.
FollowInstructionsForUse
Readandunderstandtheoperator'smanualbeforeusingthedevice
orproduct.
Asamandatoryactionsign,thissymbolisidentiedbyablue
backgroundandwhitesymbol.
CAUTION:
SAFETYGROUNDPRECAUTION
Pullingonthecablecancausethecordtodeteriorateresultingin
electricalproblems.
Removethepowercordfromthemainssourcebygraspingthe
plug.DONOTpullonthecable.
CAUTION:
CONSULTACCOMPANYINGDOCUMENTS
Theremaybespecicwarningsorprecautionsassociatedwiththe
devicethatarenototherwisefoundonthelabel.
Consulttheaccompanyingdocumentationformoreinformation
aboutsafelyusingthisdevice.
CAUTION:
ELECTRICSHOCK
Indicatesthepresenceofhazardousenergycircuitsorelectric
shockhazards.
Toreducetheriskofelectricshockhazards,donotopenthis
enclosure.Referservicingtoqualiedpersonnel.
CAUTION:
HOTSURFACE
Indicatesthatthemarkeditemmaybehot.
Takeappropriateprecautionsbeforetouchingtheitem.
WARNING:
BODILYINJURY
Indicatesthepresenceofmechanicalpartsthatcanresultin
pinching,crushing,orotherbodilyinjury.
Toavoidriskofbodilyinjury,keepawayfrommovingparts.
Disconnectpowerbeforereachingintoareaorservicing.
Asawarningsign,thissymbolisidentiedbyayellowbackground,black
triangularband,andablacksymbol.
20MAC™20002053535-002K