GE MAC 600 User manual

GEHealthcare
MAC™600
RestingECGAnalysisSystem
Operator'sManual
SoftwareVersion1.0
2047426-001RevisionK
MAC600RestingECGAnalysisSystem
English
©2009-2022GeneralElectricCompany.
AllRightsReserved.
General user documentation. Copyright General Electric company. GE proprietary. Reproduction and/or distribution is prohibited.

PublicationInformation
TheinformationinthisdocumentappliesonlytoMACTM600RestingECGAnalysisSystemVersion1.0.Itdoesnotapplytoearlierproductversions.
Duetocontinuingproductinnovation,specicationsinthisdocumentaresubjecttochangewithoutnotice.
CardioSoft,HookupAdvisor,MAC,MUL TI-LINK,MUSE,MACTRODE,and12SLaretrademarksownedbyGEMedicalSystemsInformation
Technologies,Inc.,aGeneralElectricCompanygoingtomarketasGEHealthcare.Allothertrademarkscontainedhereinarethepropertyof
theirrespectiveowners.
IndiaHeadquarters
WiproGEHealthcarePvt.Ltd.
No.4,KadugodiIndustrialArea
Bangalore-560067
Karnataka
India
Tel:[phone]/25/26
Fax:[phone]
www.gehealthcare.com
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01Apr2022

GEHealthcareAddendum
MACECGCarts
2098702-001RevisionB
2December2016
PrintingtheWrongECGforaPatient
ComputerizedelectrocardiographscanprintECGsthathavebeenpreviouslyacquired.
Consequently,ifECGsareconsecutivelyacquiredwithoutanypatientinformation,theprobability
ofinadvertentlyprintingapreviouslyacquiredECGandusingitasifitisthepatient’scurrent
ECGisincreased.
Toavoidtheproblem,acquireECGsusingthestepsoutlinedinthisdocument.Alwayscheckthe
date/timestampedonthereporttoseeifitmatchesthedate/timewhenyouacquiredtheECG.
GEMedicalSystemsInformationTechnologies,Inc.,aGeneralElectric
Company,goingtomarketasGEHealthcare.
8200WestTowerAvenueMilwaukee,WI53223U.S.A.
©2016GeneralElectricCompany.
AllRightsReserved.

PayAttentiontoAcquisitionDateandTime
EveryprintedreportcontainsthedateandtimewhentheECGwasacquired.Thisisforseveral
reasons:
lIfthereisnopatientidenticationinformationonthereport,itservesastheonlyunique
identierforthatreport.
lIfmultipleECGsareacquiredforapatient,thedate/timeisusedtosortthesetofserialECGsso
aphysiciancanmakesenseoftheECGchangesnecessaryforidentifyingspecicconditions.[1]
lToproperlyassessapatientandinterprettheirECG,itisimportanttoknowwhentheECGwas
takeninrelationtothepatient’ssymptomsand/ortreatment.[1,2,3]
lAcquiringatimelyECGhasbeenfoundtobethemostimportantfactorinreducing
time-to-treatmentforemergencycardiaccatheterizationlabprocedures.[4,5,6,7]Therefore,
thedateandtimeofanECGisarequiredmetricforEuropeandataregistriesusedtoevaluate
andimprovetime-to-treatment.[8,9,10,11]
Asaresult,GEHealthcareprintstheacquisitiondate/timeoneveryreportandthispracticehas
beenadoptedasasafetyandperformancerequirementforcomputerizedelectrocardiographsin
Europe.[12]
HowToCheckDateAndTimeOfECGAcquisition
BeforedeliveringanECGreportthatyouacquired,alwaysconrmthatthedateandtimestamped
onthereportmatchesthecurrentdateandtimedisplayedontheelectrocardiograph.Seethe
followingexample:
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2098702-001BMACECGCarts3

ItemDescription
1Time/Datestampedonprintedreportshouldmatchthetimeanddatethat
youacquiredtheECG.
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StepsforAcquiringanECG
Therearemanyeducationalmaterialsavailablethatdescribeproperskinpreparation,lead
placement,andsoon,toobtainaqualityECGrecording.Insteadofreiteratingthese,thisdocument
focusesontheinteractionbetweentheuserandthecomputerizedelectrocardiographtoeliminate
thepossibilitythatapreviouslyacquiredECGcouldbemistakenlyprintedandusedasifitisthe
patient’scurrentECG.
1.TurnTheDeviceOnAndConnectThePatient
Thefollowingdiagramrepresentsthelayoutofthescreenwhenthedeviceisturnedon.As
eachlead-wireisattachedtothepatient,theECGsignalforthatleadisupdatedonthe
displayinreal-time.
Theoverallpurposeofthisdisplayistohelptheuserdeterminewhetherthequalityofthe
ECGsignalisadequateforobtaininga12-leadECGrecordthatcanbeprinted,transmitted
and/orstored.TheusercanselectspecicECGleadsforcloserinspectionwhileapplying
differentgainorltersettings.Sinceittakessometimefortheskin/electrodeinterfaceto
2098702-001BMACECGCarts5

settlebeforeaqualityECGcanbeobtained,itiscustomaryduringthisphaseofthetestto
enterpatientinformation.
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Thebottomofthescreenhaslabelsthatindicatethecurrentfunctionofthesoftkeyslocated
directlyunderneaththedisplay.Somedeviceshavefewersoftkeysordedicatedhardkeys
forthesefunctions.1
2.EnterPatientIdentication
Whenpossible,enterpatientidenticationinformation.Regulatorybodieshavealready
identiedthataleadingcauseofmedicalerrorsisthelackofpatientidentication
informationonclinicalreports.Sincecomputerizedelectrocardiographscanstoreandprint
previouslyacquiredECGs,thereisapossibilitythataprintedreportcanbeassociatedwith
thewrongpatient.Sometimes,therearesituationswhenpatientinformationcannotbe
entered,suchasduringanemergency.However,ifECGsareroutinelyacquiredwithoutany
patientinformation,theprobabilityofinadvertentlyprintingapreviouslyacquiredECGand
mistakenlyusingitasifitisthepatient’scurrentECGisincreased.
ItispossibletoconguresomeGEHealthcareelectrocardiographstorequiresomeformof
patientidenticationtobeenteredbeforeanECGisacquired.However,ifauserdoesnot
wanttoeverenteranypatientinformation,thentheaforementionedcongurationwillbe
rendereduselessandturnedoff.
Optionstoconsider:Barcodescannerorotherautomatedapproach
Ifyourclinicalenvironmentusesbarcodes,someGEHealthcareelectrocardiographscan
beoptionallyconguredwithabarcodescanner.Thismakesitveryeasytoenteraccurate
patientdemographicsfromthepatient’swristbandoraprintedlabel.Inamatterofseconds,
anECGrecordcanbeuniquelyidentiedandassociatedwiththecorrectpatientinformation
withoutanytypographicalerrors.GEHealthcaredevicescanalsosupportcardreadersor
othersophisticatedsolutions,suchasautomaticallyinterfacingwithsystemsthatprovide
patientinformation.
1.TheMAC1200hasnosoftkeys.Allfunctionsaresupportedviahardkeys.Forexample,patientinformationisselectedviaadedicatedhard
key.MAC600,MAC800have4softkeys.MAC1600,MAC2000,MAC3500,MAC5000,MAC5500,andMAC5500HDhave6softkeysasshown
instep1.
2098702-001BMACECGCarts7

3.PressTheHardKeyToAcquireAnECG
Toacquirea12-leadECGrecord,pressthehardkeyoftheelectrocardiographdedicatedfor
thispurpose.2Onsomedevicemodels,thepatientcablealsohasahardkeyforacquiringan
ECG.
Ifyoupressthehardkeyagain,anotherECGwillbeacquiredwithalatertimestampof
acquisition.
2.OntheMAC1200,thehardkeyisgreenandlabeled“start”.FortheotherMACcarts,theyhardkeyislabeled“ECG”.
8MACECGCarts2098702-001B

4.Print/CopyKeysNowEnabled
Atthispoint,thescreenmenuwilldisplayasfollows.3
Thisistheonlypointintheworkowwhentheprint/copykeysareactive.Thepurposeofthe
print/copykeysistoallowyoutoinspecttheECGreportonthedisplaybeforeprintingitor,if
necessary,generateextracopies.
Duringthisstep,ifyoupressthehardkeytorecordanECG,itwillacquireanotherECGusing
thesamedemographics.Butevenmoreimportantly,thisfreshlyacquiredECGwillreplace
theprioronethatwaswaitingtobeprintedwiththeprint/copykeys.
5.SelectAnyOtherSoftKey-Print/CopyKeysBecomeDisabled
If“SamePat”or“NextPat”isselected,thedevicewillreturntostep1withthepatient
demographicsappropriatelyretainedorcleared.4
6.WhenYouAreFinished
Turnthedeviceoff.5Or,ifitispreferabletoleavethedeviceon,putitbacktothe“MainMenu”
orselect“NextPat”.Donotleavethedeviceinastatewhereitisintheprocessofacquiring
3.Somedevicescanbeconguredtohaveaprintpreviewscreen.Inthiscase,thescreenisnolongershowingreal-timewaveforms.Instead,
thereportthathasjustbeenacquiredisdisplayed.Ifyouwanttoacceptthatreport,youselect“continue”andthenthenextscreenthatis
displayedshowninstep4.
4.OntheMAC1200,ifthehardkey“PatInfo”ispressed,thehard“Copy”keywillbedisabled.
5.Somedevicescanbeconguredtoautomaticallyturnoff.
2098702-001BMACECGCarts9

anECGreportforapatient.Remember,thenextpersonmayhavelesstrainingthanyoudo.
Sopleaseleavethedeviceinastatethatisreadytostartanewtest.
WhatYouShouldDo:
AnyofthefollowingactionswillpreventtheoccurrenceofprintingthewrongECGforapatient:
lPushingtheECGbuttontorecordanECG,or
lPushing“NextPatient”,“SamePatient”,or“MainMenu”afterECGtestiscomplete,or
lTurningthedeviceoffbetweenuse,or
lEnteringpatientinformationforeachpatient.
lAlwayscheckthedate/timeofacquisitiontoseeifitmatchesthetimethatyouacquiredthe
ECG.
10MACECGCarts2098702-001B

Bibliography
1.Rof,M.,etal.,2015ESCGuidelinesforthemanagementofacutecoronarysyndromesin
patientspresentingwithoutpersistentST-segmentelevation.TaskForcefortheManagement
ofAcuteCoronarySyndromesinPatientsPresentingwithoutPersistentST-SegmentElevation
oftheEuropeanSocietyofCardiology(ESC),2016.37(3):p.267-315.
2.Priori,S.G.,etal.,2015ESCGuidelinesforthemanagementofpatientswithventricular
arrhythmiasandthepreventionofsuddencardiacdeath.TheTaskForcefortheManagement
ofPatientswithVentricularArrhythmiasandthePreventionofSuddenCardiacDeathofthe
EuropeanSocietyofCardiology(ESC)Endorsedby:AssociationforEuropeanPaediatricand
CongenitalCardiology(AEPC),2015.
3.Kristensen,S.D.,etal.,2014ESC/ESAGuidelinesonnon-cardiacsurgery:cardiovascular
assessmentandmanagement.TheJointTaskForceonnon-cardiacsurgery:cardiovascular
assessmentandmanagementoftheEuropeanSocietyofCardiology(ESC)andtheEuropean
SocietyofAnaesthesiology(ESA).Vol.35.2014.2383-2431.
4.Rasmussen,M.B.,etal.,Diagnosticperformanceandsystemdelayusingtelemedicinefor
prehospitaldiagnosisintriagingandtreatmentofSTEMI.Heart,2014.100(9):p.711-715.
5.Tödt,T.,etal.,StrategiesToreducetimedelaysinpatientswithAcutecoronaryheartdisease
treatedwithprimaryPCI—theSTOPWATCHstudy:amultistageactionresearchproject.BMJ
Open,2013.3(9).
6.Peterson,E.D.,etal.,AcalltoACTION(acutecoronarytreatmentandinterventionoutcomes
network):anationalefforttopromotetimelyclinicalfeedbackandsupportcontinuous
qualityimprovementforacutemyocardialinfarction.Circulation.Cardiovascularquality
andoutcomes,2009.2(5):p.491-9.
7.Lassen,J.F.,H.E.Botker,andC.J.Terkelsen,Timelyandoptimaltreatmentofpatientswith
STEMI.NatRevCardiol,2013.10(1):p.41-48.
8.Danchin,N.,etal.,Comparisonofthrombolysisfollowedbybroaduseofpercutaneouscoronary
interventionwithprimarypercutaneouscoronaryinterventionforST-segment-elevation
acutemyocardialinfarction:datafromthefrenchregistryonacuteST-elevationmyocardial
infarction(FAST-MI).Circulation,2008.118(3):p.268-76.
2098702-001BMACECGCarts11

9.Montalescot,G.,etal.,STEMIandNSTEMI:aretheysodifferent?1yearoutcomesinacute
myocardialinfarctionasdenedbytheESC/ACCdenition(theOPERAregistry).EurHeartJ,
2007.28(12):p.1409-17.
10.Gitt,A.K.,etal.,BENCHMARKINGINTHEMYOCARDIALINFARCTIONREGISTRY
RHEINLAND-PFALZ(MIR-RLP)RESULTEDININCREASEINPRE-HOSPITALECG-RECORDINGAND
REDUCTIONINISCHEMICTIMETOREPERFUSIONINSTEMI.JournaloftheAmericanCollege
ofCardiology,2016.67(13_S):p.658-658.
11.Hamm,C.W.,etal.,ESCGuidelinesforthemanagementofacutecoronarysyndromes
inpatientspresentingwithoutpersistentST-segmentelevation:TheTaskForceforthe
managementofacutecoronarysyndromes(ACS)inpatientspresentingwithoutpersistent
ST-segmentelevationoftheEuropeanSocietyofCardiology(ESC).EuropeanHeartJournal,
2011.32(23):p.2999-3054.
12.InternationalStandard60601-2-25:2011Medicalelectricalequipment.Particularrequirements
forsafety,includingessentialperformance,ofrecordingandanalysingsinglechanneland
multichannelelectrocardiographs,I.E.C.(IEC),Editor2011,InternationalElectrotechnical
Commission(IEC).p.190.
PublicationInformation
RevisionHistory
Thedocumentpartnumberandrevisionareoneachpageofthedocument.Therevisionidenties
thedocument’supdatelevel.Therevisionhistoryofthisdocumentissummarizedinthefollowing
table.
RevisionDateDescription
A29August2016Internalrelease.
B2December2016Initialcustomerrelease.
12MACECGCarts2098702-001B

ToaccessotherGEHealthcareDiagnosticCardiologydocuments,gototheCommon
DocumentationLibrary(CDL),locatedatwww.gehealthcare.com/documents,andclickCardiology.
AdditionalAssistance
GEHealthcaremaintainsatrainedstaffofapplicationandtechnicalexpertstoanswerquestions
andrespondtoissuesandproblemsthatmayariseduringtheinstallation,maintenance,anduse
ofthissystem.
ContactyourlocalGEHealthcarerepresentativetorequestadditionalassistance.
2098702-001BMACECGCarts13

Thisproductcomplieswiththerequirementsconcerningmedicaldevicesfromthefollowingregulatorybodies.Formoreinformationabout
compliance,refertotheRegulatoryandSafetyGuideforthisproduct.
DateofrstCEmark—2010.
Thedocumentpartnumberandrevisionareoneachpageofthedocument.Therevisionidentiesthedocument’supdatelevel.Therevision
historyofthisdocumentissummarizedinthefollowingtable.
RevisionDateHistory
A01October2009Initialreleaseofmanual
B14October2009Revisedperfeedbackfromvalidation
C28June2011RevisedIntendedUsestatement.Added
CardioSoftconguration.UpdatedSerial
Transmission.
D15July2013UpdatedtheTUVsymbol,theproductlabel,
andtheBackViewphoto.
E7July2016Addedwarningandsymbols.Updatedback
viewimageofproduct.
F28June2017Removedcleaningproceduresforpatient
cables,leadwires,andelectrodes.
G13July2017UpdatedimagesofBackViewinEquipment
OverviewandinConnectingtheACDCPower
AdapterinMaintenance.
H15February2019UpdatedCerticationInformation.
2047426-001KMAC™6003

J11November2021Updatedgraphicsonpage35,36and45.
Added"CleaningMaterialstoUse"and
"CleaningMaterialstoAvoid"sectionsin
AppendixA.
K01April2022UpdatedCerticationInformation.
Added“OrderingOptionalAccessories”
Added“NoteinECGOptions–AfterAcquiring
anECG
UpdatedDeletingStoredECGs
UpdatedUsingSD(SecuredData)Card
UpdatedAccessingtheSetupFunction
UpdatedSystemPasswordinformationin
MiscellaneousSetup
AddedChangePassword
AddedResetPassword
UpdatedStorageFormatInformationin
Storage.
AddedSecurityInformation
ToaccessotherGEHealthcareDiagnosticCardiologydocuments,gototheCommonDocumentationLibrary(CDL),locatedat
www.gehealthcare.com/documents,andclickCardiology.
ToaccessOriginalEquipmentManufacturer(OEM)documents,gotothedevicemanufacturer'swebsite.
ThisdocumentdescribestheMAC600RestingECGAnalysisSystem,alsoreferredtoasthe"product","system",or"device".Thisdocument
isintendedtobeusedbyqualiedmedicalpersonnelwhohavereceivedpropermedicalandproducttraining,andthosewhouse,maintain,
and/ortroubleshoottheMAC600system.
Thisdocumentisintendedasasupplementto,notasubstitutefor,thoroughproducttraining.Ifyouhavenotreceivedtrainingontheuseofthe
system,youshouldrequesttrainingassistancefromGEHealthcare.
Toseeavailabletraining,gototheGEHealthcaretrainingwebsite(www.gehealthcare.com/training).SelectEducation>Product
Education-Technical>DiagnosticCardiology.
Formoreself-pacedcourseofferings,tools,andreferenceguidesyoumaynduseful,pleasevisittheGEHealthcareEducationStoreat
www.gehealthcare.com/educationstore.
4MAC™6002047426-001K
01Apr2022

ForTinyCryptCryptographicLibraryusedinMAC600,Copyright(c)2017,IntelCorporation.Allrightsreserved.THISSOFTWAREISPROVIDED
BYTHECOPYRIGHTHOLDERSANDCONTRIBUTORS"ASIS"ANDANYEXPRESSORIMPLIEDWARRANTIES,INCLUDING,BUTNOTLIMITEDTO,THE
IMPLIEDWARRANTIESOFMERCHANTABILITYANDFITNESSFORAPARTICULARPURPOSEAREDISCLAIMED.INNOEVENTSHALLTHECOPYRIGHT
OWNERORCONTRIBUTORSBELIABLEFORANYDIRECT,INDIRECT,INCIDENTAL,SPECIAL,EXEMPLARY,ORCONSEQUENTIALDAMAGES(INCLUDING,
BUTNOTLIMITEDTO,PROCUREMENTOFSUBSTITUTEGOODSORSERVICES;LOSSOFUSE,DATA,ORPROFITS;ORBUSINESSINTERRUPTION)
HOWEVERCAUSEDANDONANYTHEORYOFLIABILITY,WHETHERINCONTRACT,STRICTLIABILITY,ORTORT(INCLUDINGNEGLIGENCEOR
OTHERWISE)ARISINGINANYWAYOUTOFTHEUSEOFTHISSOFTWARE,EVENIFADVISEDOFTHEPOSSIBILITYOFSUCHDAMAGE.
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Contents
1Introduction
ManualInformation........................................................................................15
Purpose......................................................................................................15
IntendedAudience.........................................................................................15
IndicationsforUse.........................................................................................15
Contraindications..........................................................................................16
ClinicalBenets.............................................................................................16
ProductReference..........................................................................................16
Illustrations..................................................................................................16
BlankPages.................................................................................................17
SafetyInformation..........................................................................................17
SafetyMessages............................................................................................17
ApplicableHazardMessages.............................................................................17
Classication................................................................................................21
CerticationInformation..................................................................................22
Biocompatibility.............................................................................................23
ResponsibilityoftheManufacturer......................................................................23
GeneralInformation........................................................................................23
RecordingECGsduringDebrillation...................................................................23
RecordingECGSofPacemakerPatients................................................................24
AccuracyoftheInputSignalReproduction............................................................24
ModulatingEffectsinDigitalSystems..................................................................24
EMI/EMC/RFSafetyInformation.........................................................................25
SecurityInformation.......................................................................................26
PartsandAccessories.....................................................................................26
2047426-001KMAC™6007