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
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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
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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