GE MAC 2000 User manual

GEHealthcare
MAC™2000ECGAnalysisSystem
ServiceManual
SoftwareVersion1.1
2053535-003RevisionC
English
©2013GeneralElectricCompany.
AllRightsReserved.

PublicationInformation
TheinformationinthismanualappliesonlytotheMAC™2000ECGAnalysisSystem,Version1.1.Itdoesnotapplytoearlierproductversions.
Duetocontinuingproductinnovation,specicationsinthismanualaresubjecttochangewithoutnotice.
MUSE,MACIT,CASE/CardioSoft,and12SLaretrademarksownedbyGEMedicalSystemsInformationTechnologies,Inc.,aGeneralElectric
CompanygoingtomarketasGEHealthcare.Allothertrademarkscontainedhereinarethepropertyoftheirrespectiveowners.
Thisproductcomplieswiththerequirementsconcerningmedicaldevicesfromthefollowingregulatorybodies:
Thedocumentpartnumberandrevisionareoneachpageofthedocument.Therevisionidentiesthedocument’supdatelevel.Therevision
historyofthisdocumentissummarizedinthefollowingtable.
RevisionDateComments
A17October2012Internalrelease
B15July2013CustomerRelease
C13August2013UpdatedforSPR229270.
ToaccessotherGEHealthcareDiagnosticCardiologymanuals,gototheCommonDocumentationLibrary(CDL),locatedat
www.gehealthcare.com/documents
,andclickCardiology.
ToaccessOriginalEquipmentManufacturer(OEM)manuals,gotothedevicemanufacturer'sWebsite.
ServiceManualLanguageInformation
WARNING
(EN)
ThisservicemanualisavailableinEnglishonly.
•Ifacustomer'sserviceproviderrequiresalanguageotherthanEnglish,itisthecustomer's
responsibilitytoprovidetranslationservices.
•Donotattempttoservicetheequipmentunlessthisservicemanualhasbeenconsulted
andisunderstood.
•Failuretoheedthiswarningmayresultininjurytotheserviceprovider,operator,orpatient,
fromelectricshock,mechanicalorotherhazards.
ПРЕДУПРЕЖДЕНИЕ
(BG)
Товаупътванезаработаеналичносамонаанглийскиезик.
•Акодоставчикътнауслугатанаклиентаизискадругезик,задължениенаклиентае
даосигурипревод.
•Неизползвайтеоборудването,предидастесеконсултиралииразбралиупътването
заработа.
•Неспазванетонатовапредупреждениеможедадоведедонараняваненадоставчика
науслугата,оператораилипациентврезултатнатоковударилимеханичнаили
другаопасност.
警告
ZH-CN
本维修手册仅提供英文版本。
•如果维修服务提供商需要非英文版本，客户需自行提供翻译服务。
•未详细阅读和完全理解本维修手册之前，不得进行维修。
•忽略本警告可能对维修人员，操作员或患者造成触电、机械伤害或其他形式的伤害。
2MAC™2000ECGAnalysisSystem2053535-003C
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ServiceManualLanguageInformation(cont'd.)
警告
(ZH-TW)
本維修手冊只提供英文版。
•如果客戶的維修人員有英語以外的其他語言版本需求，則由該客戶負責提供翻
譯服務。
•除非您已詳閱本維修手冊並了解其內容，否則切勿嘗試對本設備進行維修。
•不重視本警告可能導致維修人員、操作人員或病患因電擊、機械因素或其他因素
而受到傷害。
UPOZORENJE
(HR)
Oveuputezaservisiranjedostupnesusamonaengleskomjeziku.
•Ukolikokorisničkiserviszahtijevanekidrugijezik,korisnikovajeodgovornostosigurati
odgovarajućiprijevod.
•Nemojtepokušavatiservisiratiopremuukolikonistekonzultiraliirazumjelioveupute.
•Nepoštivanjeovogupozorenjamožerezultiratiozljedamaservisnogosoblja,korisnikaili
pacijentaprouzročenimelektričnimudaromtemehaničkimilinekimdrugimopasnostima.
VAROVÁNÍ
(CS)
Tentoprovoznínávodexistujepouzevanglickémjazyce.
•Vpřípadě,žeexterníslužbazákazníkůmpotřebujenávodvjinémjazyce,jezajištění
překladudoodpovídajícíhojazykaúkolemzákazníka.
•Nesnažteseoúdržbutohotozařízení,anižbystesipřečetlitentoprovoznínávoda
pochopilijehoobsah.
•Vpřípaděnedodržovánítétovarovánímůžedojítkporaněnípracovníkaprodejního
servisu,obslužnéhopersonálunebopacientůvlivemelektrickéhoproudu,respektive
vlivemmechanickýchčijinýchrizik.
ADVARSEL
(DA)
Denneservicemanualndeskunpåengelsk.
•Hvisenkundesteknikerharbrugforetandetsprogendengelsk,erdetkundensansvar
atsørgeforoversættelse.
•Forsøgikkeatservicereudstyretmedmindredenneservicemanualharværetkonsulteret
ogerforstået.
•Manglendeoverholdelseafdenneadvarselkanmedføreskadepågrundafelektrisk,
mekaniskellerandenfareforteknikeren,operatørenellerpatienten.
WAARSCHUWING
(NL)
DezeservicemanualisalleeninhetEngelsverkrijgbaar.
•Indienhetonderhoudspersoneeleenanderetaalnodigheeft,danisdeklant
verantwoordelijkvoordevertalingervan.
•Probeerdeapparatuurnietteonderhoudenvoordatdezeservicemanualgeraadpleegd
enbegrepenis.
•Indiendezewaarschuwingnietwordtopgevolgd,zouhetonderhoudspersoneel,de
gebruikerofeenpatiëntgewondkunnenrakenalsgevolgvaneenelektrischeschok,
mechanischeofanderegevaren.
HOIATUS
(ET)
Käesolevteenindusjuhendonsaadavalainultinglisekeeles.
•Kuiklienditeeninduseosutajanõuabjuhenditinglisekeelesterinevaskeeles,vastutab
klienttõlketeenuseosutamiseeest.
•Ärgeüritageseadmeidteenindadaenneeelnevaltkäesolevateenindusjuhendiga
tutvumistjasellestarusaamist.
•Käesolevahoiatuseeiraminevõibpõhjustadateenuseosutaja,operaatorivõipatsiendi
vigastamistelektrilöögi,mehaanilisevõimuuohutagajärjel.
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ServiceManualLanguageInformation(cont'd.)
VAROITUS
(FI)
Tämähuolto-ohjeonsaatavillavainenglanniksi.
•Josasiakkaanhuoltohenkilöstövaatiimuutakuinenglanninkielistämateriaalia,tarvittavan
käännöksenhankkiminenonasiakkaanvastuulla.
•Äläyritäkorjatalaitteistoaennenkuinoletvarmastilukenutjaymmärtänyttämän
huolto-ohjeen.
•Mikälitätävaroitustaeinoudateta,seurauksenavoiollahuoltohenkilöstön,laitteiston
käyttäjäntaipotilaanvahingoittuminensähköiskun,mekaanisenviantaimuun
vaaratilanteenvuoksi.
ATTENTION
(FR)
Cemanueltechniquen'estdisponiblequ'enanglais.
•Siunservicetechniqueclientsouhaiteobtenircemanueldansuneautrelangueque
l'anglais,ildevraprendreenchargelatraductionetlaresponsabilitéducontenu.
•Nepastenterd'intervenirsurleséquipementstantquelemanueltechniquen'apasété
consultéetcompris.
•Lenon-respectdecetavertissementpeutentraînerchezletechnicien,l'opérateuroule
patientdesblessuresduesàdesdangersélectriques,mécaniquesouautres.
WARNUNG
(DE)
DieseServiceanleitungistnurinenglischerSpracheverfügbar.
•FallsderKundendiensteineandereSprachebenötigt,musserfüreineentsprechende
Übersetzungsorgen.
•KeineWartungdurchführen,ohnedieseServiceanleitunggelesenundverstandenzu
haben.
•BeiZuwiderhandlungkanneszuVerletzungendesKundendiensttechnikers,des
AnwendersoderdesPatientendurchStromschläge,mechanischeodersonstigeGefahren
kommen.
ΠΡΟΕΙΔΟΠΟΙΗΣΗ
(GR)
Τοπαρόνεγχειρίδιοσέρβιςδιατίθεταιστααγγλικάμόνο.
•Εάντοάτομοπαροχήςσέρβιςενόςπελάτηαπαιτείτοπαρόνεγχειρίδιοσεγλώσσαεκτός
τωναγγλικών,αποτελείευθύνητουπελάτηναπαρέχειυπηρεσίεςμετάφρασης.
•Μηνεπιχειρήσετετηνεκτέλεσηεργασιώνσέρβιςστονεξοπλισμόεκτόςεάνέχετε
συμβουλευτείκαιέχετεκατανοήσειτοπαρόνεγχειρίδιοσέρβις.
•Εάνδενλάβετευπόψητηνπροειδοποίησηαυτή,ενδέχεταιναπροκληθείτραυματισμός
στοάτομοπαροχήςσέρβις,στοχειριστήήστονασθενήαπόηλεκτροπληξία,μηχανικούς
ήάλλουςκινδύνους.
FIGYELMEZTETÉS
(HU)
Ezaszervizkézikönyvkizárólagangolnyelvenérhetőel.
•Haavevőszervizellátójaangoltóleltérőnyelvretartigényt,akkoravevőfelelőssége
afordításelkészíttetése.
•Nepróbáljaelkezdenihasználniaberendezést,amígaszervizkézikönyvbenleírtakat
nemértelmeztékésértettékmeg.
•Ezengyelmeztetésgyelmenkívülhagyásaaszervizellátó,aműködtetővagyapáciens
áramütés,mechanikaivagyegyébveszélyhelyzetmiattisérüléséteredményezheti.
AÐVÖRUN
(IS)
Þessiþjónustuhandbókereingöngufáanlegáensku.
•Efaðþjónustuveitandiviðskiptamannsþarfnastannarstungumálsenensku,erþaðskylda
viðskiptamannsaðskaffatungumálaþjónustu.
•Reyniðekkiaðafgreiðatækiðnemaþessiþjónustuhandbókhefurveriðskoðuðogskilin.
•Brotáaðsinnaþessariaðvörungeturleitttilmeiðslaáþjónustuveitanda,stjórnandaeða
sjúklingifráraosti,vélrænumeðaöðrumáhættum.
4MAC™2000ECGAnalysisSystem2053535-003C
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ServiceManualLanguageInformation(cont'd.)
PERINGATAN
(ID)
ManualservisinihanyatersediadalambahasaInggris.
•JikapenyediajasaservispelangganmemerlukanbahasalainselaindariBahasaInggris,
merupakantanggungjawabdaripenyediajasaservistersebutuntukmenyediakan
terjemahannya.
•Janganmencobamelakukanservisterhadapperlengkapankecualitelahmembacadan
memahamimanualservisini.
•Mengabaikanperingataninibisamengakibatkancederapadapenyediaservis,operator,
ataupasien,karenaterkenakejutlistrik,bahayamekanisataubahayalainnya.
AVVERTENZA
(IT)
IlpresentemanualedimanutenzioneèdisponibilesoltantoinInglese.
•Seunaddettoallamanutenzionerichiedeilmanualeinunalinguadiversa,ilclienteè
tenutoaprovvederedirettamenteallatraduzione.
•Siprocedaallamanutenzionedell'apparecchiaturasolodopoaverconsultatoilpresente
manualeedavernecompresoilcontenuto.
•Ilnonrispettodellapresenteavvertenzapotrebbefarcompiereoperazionidacuiderivino
lesioniall'addetto,allamanutenzione,all'utilizzatoreedalpazienteperfolgorazione
elettrica,perurtimeccaniciodaltririschi.
警告
(JA)
このサービスマニュアルは英語版しかありません。
•サービスを担当される業者が英語以外の言語を要求される場合、翻訳作業はその業
者の責任で行うものとさせていただきます。
•このサービスマニュアルを熟読し、十分に理解をした上で装置のサービスを
行ってください。
•この警告に従わない場合、サービスを担当される方、操作員あるいは患者が、感電
や機械的又はその他の危険により負傷する可能性があります。
경고
(KO)
본서비스지침서는영어로만이용하실수있습니다.
•고객의서비스제공자가영어이외의언어를요구할경우,번역서비스를제공하는것
은고객의책임입니다.
•본서비스지침서를참고했고이해하지않는한은해당장비를수리하려고시도하
지마십시오.
•이경고에유의하지않으면전기쇼크,기계상의혹은다른위험으로부터서비스제
공자,운영자혹은환자에게위해를가할수있습니다.
BRĪDINĀJUMS
(LV)
Šīapkalpotājurokasgrāmatairpieejamatikaiangļuvalodā.
•Jaapkalpošanassniedzējamnepieciešamainformācijacitā,nevisangļu,valodā,klienta
pienākumsirnodrošināttāstulkošanu.
•Neveicietaprīkojumaapkopi,neizlasotunnesaprototapkalpotājurokasgrāmatu.
•Šībrīdinājumaneievērošanavarradītelektriskāsstrāvastrieciena,mehāniskuvaiciturisku
izraisītutraumuapkopessniedzējam,operatoramvaipacientam.
ĮSPĖJIMAS
(LT)
Šiseksploatavimovadovasyraprieinamastikanglųkalba.
•Jeiklientopaslaugųtiekėjasreikalaujavadovokitakalba-neanglų,numatytivertimo
paslaugasyraklientoatsakomybė.
•Nemėginkiteatliktiįrangostechninėspriežiūros,nebentatsižvelgėteįšįeksploatavimo
vadovąirjįsupratote.
•Jeineatkreipsitedėmesioįšįperspėjimą,galimisužalojimaidėlelektrosšoko,mechaninių
arkitųpaslaugųtiekėjui,operatoriuiarpacientui.
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ServiceManualLanguageInformation(cont'd.)
ADVARSEL
(NO)
Denneservicehåndbokennnesbarepåengelsk.
•Hviskundensserviceleverandørtrengeretannetspråk,erdetkundensansvaråsørge
foroversettelse.
•Ikkeforsøkåreparereutstyretutenatdenneservicehåndbokenerlestogforstått.
•Manglendehensyntildenneadvarselenkanføretilatserviceleverandøren,operatøren
ellerpasientenskadespågrunnavelektriskstøt,mekaniskeellerandrefarer.
OSTRZEŻENIE
(PL)
Niniejszypodręcznikserwisowydostępnyjestjedyniewjęzykuangielskim.
•Jeślidostawcausługklientawymagajęzykainnegoniżangielski,zapewnienieusługi
tłumaczeniajestobowiązkiemklienta.
•Nienależyserwisowaćwyposażeniabezzapoznaniasięizrozumienianiniejszego
podręcznikaserwisowego.
•Niezastosowaniesiędotegoostrzeżeniamożespowodowaćurazydostawcyusług,
operatoralubpacjentawwynikuporażeniaelektrycznego,zagrożeniamechanicznego
bądźinnego.
AVISO
(PT-BR)
Estemanualdeassistênciatécnicasóseencontradisponíveleminglês.
•SeoserviçodeassistênciatécnicadoclientenãoforGE,eprecisardeoutroidioma,será
daresponsabilidadedoclientefornecerosserviçosdetradução.
•Nãotenterepararoequipamentosemterconsultadoecompreendidoestemanualde
assistênciatécnica.
•Onãocumprimentodesteavisopodeporemperigoasegurançadotécnico,operadorou
pacientedevidoachoqueselétricos,mecânicosououtros.
AVISO
(PT-PT)
Estemanualtécnicosóseencontradisponíveleminglês.
•Seaassistênciatécnicadoclientesolicitarestesmanuaisnoutroidioma,éda
responsabilidadedoclientefornecerosserviçosdetradução.
•Nãotenterepararoequipamentosemterconsultadoecompreendidoestemanual
técnico.
•Onãocumprimentodesteavisopodeprovocarlesõesaotécnico,aoutilizadorouao
pacientedevidoachoqueseléctricos,mecânicosououtros.
AVERTISMENT
(RO)
Acestmanualdeserviceestedisponibilnumaiînlimbaengleză.
•Dacăunfurnizordeserviciipentruclienţinecesităoaltălimbădecâtceaengleză,estede
datoriaclientuluisăfurnizezeotraducere.
•Nuîncercaţisăreparaţiechipamentuldecâtulteriorconsultăriişiînţelegeriiacestui
manualdeservice.
•Ignorareaacestuiavertismentarputeaducelarănireadepanatorului,operatoruluisau
pacientuluiînurmapericolelordeelectrocutare,mecanicesaudealtănatură.
ПРЕДУПРЕЖДЕНИЕ
(RU)
Настоящееруководствопообслуживаниюпредлагаетсятольконаанглийскомязыке.
•Еслисервисномуперсоналуклиентанеобходиморуководствоненаанглийском,ана
каком-тодругомязыке,клиентуследуетобеспечитьпереводсамостоятельно.
•Преждечемприступатькобслуживаниюоборудования,обязательнообратитеськ
настоящемуруководствуивнимательноизучитеизложенныевнемсведения.
•Несоблюдениетребованийданногопредупрежденияможетпривестиктому,что
специалистыпообслуживанию,операторыилипациентыполучатударэлектрическим
током,механическуютравмуилидругоеповреждение.
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ServiceManualLanguageInformation(cont'd.)
UPOZORENJE
(SR)
Ovoservisnouputstvojedostupnosamonaengleskomjeziku.
•Akoklijentovserviserzahtevanekidrugijezik,klijentjedužandaobezbediprevodilačke
usluge.
•Nepokušavajtedaopraviteuređajakonistepročitaliirazumeliovoservisnouputstvo.
•Zanemarivanjeovogupozorenjamožedovestidopovređivanjaservisera,rukovaocaili
pacijentausledstrujnogudara,ilimehaničkihidrugihopasnosti.
VAROVANIE
(SK)
Tentonávodnaobsluhujekdispozíciilenvangličtine.
•Akzákazníkovposkytovateľslužiebvyžadujeinýjazykakoangličtinu,poskytnutie
prekladateľskýchslužiebjezodpovednosťouzákazníka.
•Nepokúšajtesaoobsluhuzariadeniaskôr,akosineprečítatenávodnaobsluhua
neporozumietemu.
•Zanedbanietohtovarovaniamôževyústiťdozraneniaposkytovateľaslužieb,obsluhujúcej
osobyalebopacientaelektrickýmprúdom,mechanickýmaleboinýmnebezpečenstvom.
OPOZORILO
(SL)
Taservisnipriročnikjenavoljosamovangleškemjeziku.
•Čeponudnikstoritvestrankepotrebujepriročnikvdrugemjeziku,morastrankazagotoviti
prevod.
•Neposkušajteservisiratiopreme,četegapriročnikanistevcelotiprebraliinrazumeli.
•Četegaopozorilaneupoštevate,selahkozaradielektričnegaudara,mehanskihalidrugih
nevarnostipoškodujeponudnikstoritev,operateralibolnik.
ADVERTENCIA
(ES)
Estemanualdeserviciosóloexisteeninglés.
•Sielencargadodemantenimientodeunclientenecesitaunidiomaquenoseaelinglés,el
clientedeberáencargarsedelatraduccióndelmanual.
•Nosedeberádarserviciotécnicoalequipo,sinhaberconsultadoycomprendidoeste
manualdeservicio.
•Lanoobservanciadelpresenteavisopuededarlugaraqueelproveedordeservicios,el
operadoroelpacientesufranlesionesprovocadasporcausaseléctricas,mecánicaso
deotranaturaleza.
VARNING
(SV)
Denhärservicehandbokennnsbaratillgängligpåengelska.
•Omenkundsserviceteknikerharbehovavettannatspråkänengelskaansvararkunden
föratttillhandahållaöversättningstjänster.
•Försökinteutföraservicepåutrustningenomduinteharlästochförstårdenhär
servicehandboken.
•Omduintetarhänsyntilldenhärvarningenkandetresulteraiskadorpåserviceteknikern,
operatörenellerpatiententillföljdavelektriskastötar,mekaniskafarorellerandrafaror.
UYARI
(TR)
Buserviskılavuzununsadeceİngilizcesimevcuttur.
•Eğermüşteriteknisyenibukılavuzuİngilizcedışındabirbaşkalisandantalepederse,bunu
tercümeettirmekmüşteriyedüşer.
•Serviskılavuzunuokuyupanlamadanekipmanlaramüdahaleetmeyiniz.
•Buuyarıyauyulmaması,elektrik,mekanikveyadiğertehlikelerdendolayıteknisyen,
operatörveyahastanınyaralanmasınayolaçabilir.
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ServiceManualLanguageInformation(cont'd.)
ЗАСТЕРЕЖЕННЯ
(UK)
Данекерівництвозсервісногообслуговуванняпостачаєтьсявиключноанглійськоюмовою.
•Якщосервіснийінженерпотребуєкерівництвоіншоюмовою,користувачзобов'язаний
забезпечитипослугиперекладача.
•Ненамагайтесяздійснюватитехнічнеобслуговуванняданогообладнання,якщо
винечитали,абонезрозумілиінформацію,наданувкерівництвізсервісного
обслуговування.
•Недотриманняцьогозастереженняможепризвестидотравмуваннясервісного
інженера,користувачаданогообладнанняабопацієнтавнаслідокелектричногошоку,
механічногоушкодженняабозіншихпричинневірногообслуговуванняобладнання.
CẢNHBÁO
(VI)
TàiLiệuHướngDẫnSửaChữachỉcóbảntiếngAnh.
•Nếucácđơnvịcungcấpdịchvụchokháchhàngyêucầumộtngônngữnàokháctiếng
Anh,thìkháchhàngsẽcótráchnhiệmcungcấpcácdịchvụdịchthuật.
•KhôngđượcsửachữathiếtbịtrừkhiđãthamkhảovàhiểuTàiliệuHướngdẫnSửachữa.
•Khôngtuânthủnhữngcảnhbáonàycóthểdẫnđếncáctổnthươngchongườithực
hiệnsửachữa,ngườivậnhànhhaybệnhnhân,dosốcđiện,cácrủirovềcơkhíhay
cácrủirokhác.
8MAC™2000ECGAnalysisSystem2053535-003C
13August2013

Contents
1Introduction
IntendedUserofthisProduct...................................................................13
IndicationsforUse....................................................................................13
Contraindications.....................................................................................14
PrescriptionDeviceStatement.................................................................14
RegulatoryandSafetyInformation...........................................................14
SafetyConventions..................................................................................14
SafetyHazards........................................................................................15
ClassicationofMedicalDevice...................................................................17
CerticationInformation............................................................................17
RecordingECGsDuringDebrillation.............................................................17
AccuracyofInputSignalReproduction...........................................................18
ModulatingEffectsinDigitalSystems............................................................18
EMI/EMC/RFSafetyInformation...................................................................18
Biocompatibility.......................................................................................19
LegalNotice...........................................................................................19
SuppliesandAccessories...........................................................................19
ResponsibilityoftheManufacturer................................................................20
ResponsibilityofthePurchaser/Customer.......................................................20
ProductandPackagingInformation..............................................................20
Training.................................................................................................28
EquipmentIdentication...........................................................................28
ProductLabel.........................................................................................29
SerialNumberFormat...............................................................................29
DeviceAddressLabelandRatingPlate...........................................................30
ProductCodes........................................................................................30
ServiceInformation...................................................................................31
ServiceRequirements...............................................................................31
WarrantyInformation...............................................................................31
AdditionalAssistance................................................................................31
ManualInformation..................................................................................31
ManualPurpose......................................................................................31
DocumentConventions.............................................................................31
2ProductOverview
ProductDescription..................................................................................33
HardwareOverview..................................................................................33
FrontView.............................................................................................34
RearView..............................................................................................34
SideView...............................................................................................35
InternalView..........................................................................................36
2053535-003CMAC™2000ECGAnalysisSystem9

Keypads................................................................................................37
ArchitectureandTheoryofOperation......................................................40
BlockDiagram........................................................................................40
Hardware/FirmwareArchitecture.................................................................42
ProductInterfaces....................................................................................42
3ServiceSetup
AccessingServiceSetup............................................................................43
DeviceSettings.........................................................................................44
EventLog..................................................................................................44
SettingUpEventLogging...........................................................................45
ExportingtheEventLog.............................................................................46
SystemDiagnostics...................................................................................46
TestingtheDisplay...................................................................................47
TestingtheSpeaker..................................................................................49
TestingtheKeypad...................................................................................50
TestingtheAcquisitionModule....................................................................51
CheckingtheBatteryStatus........................................................................51
TestingtheWriter....................................................................................52
CommunicationsTests..............................................................................55
TestingthePatientLeadwires......................................................................59
PrintingaServiceReport............................................................................60
UpdatingtheSoftware..............................................................................60
FormatingtheFlashMemory....................................................................68
OpeningaCommandPrompt....................................................................70
4Maintenance
RecommendedMaintenance....................................................................71
RequiredToolsandSupplies.....................................................................71
FRUReplacementProcedures...................................................................72
HighLevelFRUIdentication.......................................................................72
PreparingtheSystemforFRUReplacement....................................................73
Battery..................................................................................................74
DeviceCovers.........................................................................................75
PowerSupply..........................................................................................91
PowerInletModule...................................................................................92
Printer..................................................................................................94
DisplayAssembly...................................................................................108
Keypad...............................................................................................113
InternalModem.....................................................................................118
PWA...................................................................................................120
KISSPumpAssembly(Option)....................................................................126
FunctionalCheckout...............................................................................129
VisualInspections..................................................................................131
FunctionalCheckoutProcedures................................................................131
10MAC™2000ECGAnalysisSystem2053535-003C

5Troubleshooting
ECGDataNoise.......................................................................................135
GeneralFaultIsolation............................................................................136
PowerUpSelfTest..................................................................................136
VisualInspection....................................................................................137
EventLogging.......................................................................................138
DiagnosticTests....................................................................................138
ErrorCodes.............................................................................................138
6PartsList
PartIdentication...................................................................................141
FRULists..................................................................................................152
CoverBottom(2066261-001).....................................................................152
Printer(2066261-002).............................................................................152
PrinterMotorandGears(2066261-003)........................................................152
PrinterDoor(2066261-004).......................................................................152
CoverTop,ColorChassis,Hardware(2066261-005).........................................153
MainPWA(2066261-006).........................................................................153
DisplayPlasticParts(2066261-007).............................................................153
Keypad(StressorNon-Stress)...................................................................153
Hardware—1(2066261-009)....................................................................154
Harness/Cables(2066261-010)..................................................................154
Hardware3andPower-InModule(2066261-011)...........................................155
PowerSupply(2066261-012).....................................................................155
Battery(2066261-013).............................................................................155
Displayand‘O’Rings(2066261-014)............................................................155
DisplayOverlayand‘O’Rings(2066261-015).................................................155
CoverTopandPlasticParts—1(2066261-016)..............................................156
DoorSensorandPlasticParts—Printer/PaperTray(2066261-017)......................156
PaperSensor(2066261-018).....................................................................156
PrintHeadAssy(2066261-019)..................................................................156
StaticBrush(2066261-020).......................................................................157
KISSPump(2066261-021)........................................................................157
InternalModem(2066261-022)..................................................................157
Keypads,Non-Stress...............................................................................157
Keypads,Stress.....................................................................................158
BarcodeScannerKits(USBDataMatrix).......................................................158
PowerSupplyCords................................................................................159
SoftwareUpdateSDCard.........................................................................159
Wi-FiModule........................................................................................159
ARelatedDocuments
DocumentsRelatedtoMAC™2000ECGAnalysisSystem.......................161
DocumentsAvailableinOtherLanguages..............................................161
BElectromagneticCompatibility(EMC)
GuidanceandManufacturer’sDeclaration—Electromagnetic
Emissions................................................................................................165
GuidanceandManufacturer’sDeclaration—Electromagnetic
Immunity.................................................................................................166
2053535-003CMAC™2000ECGAnalysisSystem11

GuidanceandManufacturer’sDeclaration—Electromagnetic
Immunity.................................................................................................167
RecommendedSeparationDistances.....................................................170
CTechnicalSpecications
SystemSpecications.............................................................................171
Acquisition,Processing,andPerformance..............................................173
OperatingModes,Features,andOptions...............................................175
DWiFiCountryList
AllowableChannels.................................................................................177
12MAC™2000ECGAnalysisSystem2053535-003C

1
Introduction
ThisdocumentdescribestheMAC™2000ECGAnalysisSystem,alsoreferredtoasthe
“product”,“system”,or“device”.Thedocumentisintendedtobeusedbyanyonewho
maintainsortroubleshootsthisequipment.
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.
Arrhythmiadetectionisprovidedfortheconvenienceofautomaticdocumentation.
TransmissionandreceptionofECGdatatoandfromacentralECGcardiovascular
informationsystemisoptional.
2053535-003CMAC™2000ECGAnalysisSystem13

Introduction
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
ConventionDenition
DANGERIndicatesanimminenthazard,which,ifnotavoided,willresultindeath
orseriousinjury.
WARNINGIndicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultindeathorseriousinjury.
CAUTIONIndicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinmoderateorminorinjury.
NOTICEIndicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinthelossordestructionofpropertyordata.
14MAC™2000ECGAnalysisSystem2053535-003C

Introduction
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.
WARNING:
EQUIPMENTFAILURE—Polarizingelectrodes(stainlesssteelorsilverconstructed)
maycausetheelectrodestoretainaresidualchargeafterdebrillation.Aresidual
chargeblocksacquisitionoftheECGsignal.
Wheneverpatientdebrillationisapossibility,usenon-polarizingelectrodes
(silver-silverchlorideconstruction)forECGmonitoring.
2053535-003CMAC™2000ECGAnalysisSystem15

Introduction
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.
WARNING:
ELECTRICSHOCK—Improperconnectionofthisequipmentmaycauseelectric
shock.
Toavoidriskofelectricshock,thisequipmentmustonlybeconnectedtoasupply
mainswithprotectiveearth.
16MAC™2000ECGAnalysisSystem2053535-003C

Introduction
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.
RecordingECGsDuringDebrillation
Thisequipmentisprotectedagainsttheeffectsofcardiacdebrillatordischarge
toensurerecovery,asrequiredbyteststandards.Thepatientsignalinputofthe
acquisitionmoduleisdebrillation-proof.Therefore,itisnotnecessarytoremove
theECGelectrodespriortodebrillation.
2053535-003CMAC™2000ECGAnalysisSystem17

Introduction
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.
Beforeinstallingorusingthedeviceorsystem,beawareoftheproximityofknownRF
sources,suchasthefollowing:
•RadioandTVstations
•PortableandmobileRFcommunicationdevices(cellphones,two-wayradios)
•X-ray,CT,orMRIdevices
18MAC™2000ECGAnalysisSystem2053535-003C

Introduction
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
Biocompatibility
Thepartsofthesystemdescribedinthismanualthatcomeintocontactwiththe
patientduringtheintendeduse,includingallaccessories,fulllthebiocompatibility
requirementsoftheapplicablestandards.Ifyouhavequestionsinthismatter,contact
yourGEHealthcarerepresentative.
LegalNotice
GEHealthcaresoftwarecontainsseveraleldsthatcanbelledinbeforeperforming
anECG.Someoftheseeldsarerequired,whileothersareoptionalandlefttothe
usertoassesswhethertheyareneededtoperformtheexam.TheeldRaceisone
oftheseoptionalelds.Racehasbeenacknowledgedbythemedicalprofessionas
usefultoanalyzesomepathologies.Youshouldbeawarethat,insomejurisdictions,
theprocessingofdatarevealinganindividual'sracialoriginissubjecttolegal
requirements,suchasobtainingthepatient'spriorconsent.Ifyouelecttocollectthis
typeofdata,itisyourresponsibilitytoensurethatyoucomplywithallapplicable
legalrequirements.
SuppliesandAccessories
YoushoulduseonlysuppliesandaccessoriesthatGEHealthcarerecommends.For
alistofrecommendations,refertothesuppliesandaccessoriesreferenceguide
forthissystem
ContactGEHealthcarebeforeusinganythingthatisnotrecommendedforthissystem.
2053535-003CMAC™2000ECGAnalysisSystem19

Introduction
ResponsibilityoftheManufacturer
GEHealthcareisresponsibleforthesafety,reliability,andperformanceofhardware
suppliedbyGEHealthcareonlyifthefollowingconditionsaremet:
•Assemblyoperations,extensions,readjustments,modications,orrepairsare
performedbypersonsauthorizedbyGEHealthcare.
•Theelectricalinstallationoftheroomwherethedeviceisusedcomplieswiththe
requirementsoftheappropriatelocal,state,andothergovernmentregulations.
•Theequipmentisusedinaccordancewiththeinstructionsforuse.
ResponsibilityofthePurchaser/Customer
Thecustomerisresponsibleforprovidingappropriatedesks,chairs,electricalwall
outlets,networkconnections,andanalogphonelines,andforlocatinganyofthe
systemcomponentsdescribedinthismanualincompliancewithalllocal,state,and
nationalcodes.
ProductandPackagingInformation
Thissectionidentiesthefollowing:
•Hardwarelabelsandtheirlocationsonpage20
•SymbolDescriptionsonpage21
HardwareLabelLocations
20MAC™2000ECGAnalysisSystem2053535-003C