GE MAC 2000 Service 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.

Revision

Date

Comments

A

B

C13August2013

ToaccessotherGEHealthcareDiagnosticCardiologymanuals,gototheCommonDocumentationLibrary(CDL),locatedat

www.gehealthcare.com/documents

ToaccessOriginalEquipmentManufacturer(OEM)manuals,gotothedevicemanufacturer'sWebsite.

17October2012Internalrelease

15July2013CustomerRelease

UpdatedforSPR229270.

,andclickCardiology.

ServiceManualLanguageInformation

WARNING
(EN)

ПРЕДУПРЕЖДЕНИЕ
(BG)

警告

ZH-CN

ThisservicemanualisavailableinEnglishonly.

•Ifacustomer'sserviceproviderrequiresalanguageotherthanEnglish,itisthecustomer's

responsibilitytoprovidetranslationservices.

•Donotattempttoservicetheequipmentunlessthisservicemanualhasbeenconsulted

andisunderstood.

•Failuretoheedthiswarningmayresultininjurytotheserviceprovider ,operator ,orpatient,

fromelectricshock,mechanicalorotherhazards.

Товаупътванезаработаеналичносамонаанглийскиезик.

•Акодоставчикътнауслугатанаклиентаизискадругезик,задължениенаклиентае

даосигурипревод.

•Неизползвайтеоборудването,предидастесеконсултиралииразбралиупътването

заработа.

•Неспазванетонатовапредупреждениеможедадоведедонараняваненадоставчика

науслугата,оператораилипациентврезултатнатоковударилимеханичнаили
другаопасност.

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。

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ServiceManualLanguageInformation(cont'd.)

警告

(ZH-TW)

UPOZORENJE
(HR)

VAROVÁNÍ
(CS)

ADVARSEL
(DA)

WAARSCHUWING
(NL)

HOIATUS
(ET)

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。

Oveuputezaservisiranjedostupnesusamonaengleskomjeziku.

•Ukolikokorisničkiserviszahtijevanekidrugijezik,korisnikovajeodgovornostosigurati

odgovarajućiprijevod.

•Nemojtepokušavatiservisiratiopremuukolikonistekonzultiraliirazumjelioveupute.

•Nepoštivanjeovogupozorenjamožerezultiratiozljedamaservisnogosoblja,korisnikaili

pacijentaprouzročenimelektričnimudaromtemehaničkimilinekimdrugimopasnostima.

Tentoprovoznínávodexistujepouzevanglickémjazyce.

•Vpřípadě,žeexterníslužbazákazníkůmpotřebujenávodvjinémjazyce,jezajištění

překladudoodpovídajícíhojazykaúkolemzákazníka.

•Nesnažteseoúdržbutohotozařízení,anižbystesipřečetlitentoprovoznínávoda

pochopilijehoobsah.

•Vpřípaděnedodržovánítétovarovánímůžedojítkporaněnípracovníkaprodejního

servisu,obslužnéhopersonálunebopacientůvlivemelektrickéhoproudu,respektive
vlivemmechanickýchčijinýchrizik.

Denneservicemanualndeskunpåengelsk.

•Hvisenkundesteknikerharbrugforetandetsprogendengelsk,erdetkundensansvar

atsørgeforoversættelse.

•Forsøgikkeatservicereudstyretmedmindredenneservicemanualharværetkonsulteret

ogerforstået.

•Manglendeoverholdelseafdenneadvarselkanmedføreskadepågrundafelektrisk,

mekaniskellerandenfareforteknikeren,operatørenellerpatienten.

DezeservicemanualisalleeninhetEngelsverkrijgbaar.

•Indienhetonderhoudspersoneeleenanderetaalnodigheeft,danisdeklant

verantwoordelijkvoordevertalingervan.

•Probeerdeapparatuurnietteonderhoudenvoordatdezeservicemanualgeraadpleegd

enbegrepenis.

•Indiendezewaarschuwingnietwordtopgevolgd,zouhetonderhoudspersoneel,de

gebruikerofeenpatiëntgewondkunnenrakenalsgevolgvaneenelektrischeschok,
mechanischeofanderegevaren.

Käesolevteenindusjuhendonsaadavalainultinglisekeeles.

•Kuiklienditeeninduseosutajanõuabjuhenditinglisekeelesterinevaskeeles,vastutab

klienttõlketeenuseosutamiseeest.

•Ärgeüritageseadmeidteenindadaenneeelnevaltkäesolevateenindusjuhendiga

tutvumistjasellestarusaamist.

•Käesolevahoiatuseeiraminevõibpõhjustadateenuseosutaja,operaatorivõipatsiendi

vigastamistelektrilöögi,mehaanilisevõimuuohutagajärjel.

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ServiceManualLanguageInformation(cont'd.)

VAROITUS
(FI)

ATTENTION
(FR)

WARNUNG
(DE)

ΠΡΟΕΙΔΟΠΟΙΗΣΗ
(GR)

FIGYELMEZTETÉS
(HU)

AÐVÖRUN
(IS)

Tämähuolto-ohjeonsaatavillavainenglanniksi.

•Josasiakkaanhuoltohenkilöstövaatiimuutakuinenglanninkielistämateriaalia,tarvittavan

käännöksenhankkiminenonasiakkaanvastuulla.

•Äläyritäkorjatalaitteistoaennenkuinoletvarmastilukenutjaymmärtänyttämän

huolto-ohjeen.

•Mikälitätävaroitustaeinoudateta,seurauksenavoiollahuoltohenkilöstön,laitteiston

käyttäjäntaipotilaanvahingoittuminensähköiskun,mekaanisenviantaimuun
vaaratilanteenvuoksi.

Cemanueltechniquen'estdisponiblequ'enanglais.

•Siunservicetechniqueclientsouhaiteobtenircemanueldansuneautrelangueque

l'anglais,ildevraprendreenchargelatraductionetlaresponsabilitéducontenu.

•Nepastenterd'intervenirsurleséquipementstantquelemanueltechniquen'apasété

consultéetcompris.

•Lenon-respectdecetavertissementpeutentraînerchezletechnicien,l'opérateuroule

patientdesblessuresduesàdesdangersélectriques,mécaniquesouautres.

DieseServiceanleitungistnurinenglischerSpracheverfügbar.

•FallsderKundendiensteineandereSprachebenötigt,musserfüreineentsprechende

Übersetzungsorgen.

•KeineWartungdurchführen,ohnedieseServiceanleitunggelesenundverstandenzu

haben.

•BeiZuwiderhandlungkanneszuVerletzungendesKundendiensttechnikers,des

AnwendersoderdesPatientendurchStromschläge,mechanischeodersonstigeGefahren
kommen.

Τοπαρόνεγχειρίδιοσέρβιςδιατίθεταιστααγγλικάμόνο.

•Εάντοάτομοπαροχήςσέρβιςενόςπελάτηαπαιτείτοπαρόνεγχειρίδιοσεγλώσσαεκτός

τωναγγλικών,αποτελείευθύνητουπελάτηναπαρέχειυπηρεσίεςμετάφρασης.

•Μηνεπιχειρήσετετηνεκτέλεσηεργασιώνσέρβιςστονεξοπλισμόεκτόςεάνέχετε

συμβουλευτείκαιέχετεκατανοήσειτοπαρόνεγχειρίδιοσέρβις.

•Εάνδενλάβετευπόψητηνπροειδοποίησηαυτή,ενδέχεταιναπροκληθείτραυματισμός

στοάτομοπαροχήςσέρβις,στοχειριστήήστονασθενήαπόηλεκτροπληξία,μηχανικούς
ήάλλουςκινδύνους.

Ezaszervizkézikönyvkizárólagangolnyelvenérhetőel.

•Haavevőszervizellátójaangoltóleltérőnyelvretartigényt,akkoravevőfelelőssége

afordításelkészíttetése.

•Nepróbáljaelkezdenihasználniaberendezést,amígaszervizkézikönyvbenleírtakat

nemértelmeztékésértettékmeg.

•Ezengyelmeztetésgyelmenkívülhagyásaaszervizellátó,aműködtetővagyapáciens

áramütés,mechanikaivagyegyébveszélyhelyzetmiattisérüléséteredményezheti.

Þessiþjónustuhandbókereingöngufáanlegáensku.

•Efaðþjónustuveitandiviðskiptamannsþarfnastannarstungumálsenensku,erþaðskylda

viðskiptamannsaðskaffatungumálaþjónustu.

•Reyniðekkiaðafgreiðatækiðnemaþessiþjónustuhandbókhefurveriðskoðuðogskilin.

•Brotáaðsinnaþessariaðvörungeturleitttilmeiðslaáþjónustuveitanda,stjórnandaeða

sjúklingifráraosti,vélrænumeðaöðrumáhættum.

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ServiceManualLanguageInformation(cont'd.)

PERINGATAN
(ID)

AVVERTENZA
(IT)

警告

(JA)

경고

(KO)

BRĪDINĀJUMS
(LV)

ĮSPĖJIMAS
(LT)

ManualservisinihanyatersediadalambahasaInggris.

•JikapenyediajasaservispelangganmemerlukanbahasalainselaindariBahasaInggris,

merupakantanggungjawabdaripenyediajasaservistersebutuntukmenyediakan
terjemahannya.

•Janganmencobamelakukanservisterhadapperlengkapankecualitelahmembacadan

memahamimanualservisini.

•Mengabaikanperingataninibisamengakibatkancederapadapenyediaservis,operator,

ataupasien,karenaterkenakejutlistrik,bahayamekanisataubahayalainnya.

IlpresentemanualedimanutenzioneèdisponibilesoltantoinInglese.

•Seunaddettoallamanutenzionerichiedeilmanualeinunalinguadiversa,ilclienteè

tenutoaprovvederedirettamenteallatraduzione.

•Siprocedaallamanutenzionedell'apparecchiaturasolodopoaverconsultatoilpresente

manualeedavernecompresoilcontenuto.

•Ilnonrispettodellapresenteavvertenzapotrebbefarcompiereoperazionidacuiderivino

lesioniall'addetto,allamanutenzione,all'utilizzatoreedalpazienteperfolgorazione
elettrica,perurtimeccaniciodaltririschi.

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。

본서비스지침서는영어로만이용하실수있습니다.

•고객의서비스제공자가영어이외의언어를요구할경우,번역서비스를제공하는것

은고객의책임입니다.

•본서비스지침서를참고했고이해하지않는한은해당장비를수리하려고시도하

지마십시오.

•이경고에유의하지않으면전기쇼크,기계상의혹은다른위험으로부터서비스제

공자,운영자혹은환자에게위해를가할수있습니다.

Šīapkalpotājurokasgrāmatairpieejamatikaiangļuvalodā.

•Jaapkalpošanassniedzējamnepieciešamainformācijacitā,nevisangļu,valodā,klienta

pienākumsirnodrošināttāstulkošanu.

•Neveicietaprīkojumaapkopi,neizlasotunnesaprototapkalpotājurokasgrāmatu.

•Šībrīdinājumaneievērošanavarradītelektriskāsstrāvastrieciena,mehāniskuvaiciturisku

izraisītutraumuapkopessniedzējam,operatoramvaipacientam.

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)

VAROVANIE
(SK)

OPOZORILO
(SL)

ADVERTENCIA
(ES)

VARNING
(SV)

UYARI
(TR)

Ovoservisnouputstvojedostupnosamonaengleskomjeziku.

•Akoklijentovserviserzahtevanekidrugijezik,klijentjedužandaobezbediprevodilačke

usluge.

•Nepokušavajtedaopraviteuređajakonistepročitaliirazumeliovoservisnouputstvo.

•Zanemarivanjeovogupozorenjamožedovestidopovređivanjaservisera,rukovaocaili

pacijentausledstrujnogudara,ilimehaničkihidrugihopasnosti.

Tentonávodnaobsluhujekdispozíciilenvangličtine.

•Akzákazníkovposkytovateľslužiebvyžadujeinýjazykakoangličtinu,poskytnutie

prekladateľskýchslužiebjezodpovednosťouzákazníka.

•Nepokúšajtesaoobsluhuzariadeniaskôr ,akosineprečítatenávodnaobsluhua

neporozumietemu.

•Zanedbanietohtovarovaniamôževyústiťdozraneniaposkytovateľaslužieb,obsluhujúcej

osobyalebopacientaelektrickýmprúdom,mechanickýmaleboinýmnebezpečenstvom.

Taservisnipriročnikjenavoljosamovangleškemjeziku.

•Čeponudnikstoritvestrankepotrebujepriročnikvdrugemjeziku,morastrankazagotoviti

prevod.

•Neposkušajteservisiratiopreme,četegapriročnikanistevcelotiprebraliinrazumeli.

•Četegaopozorilaneupoštevate,selahkozaradielektričnegaudara,mehanskihalidrugih

nevarnostipoškodujeponudnikstoritev,operateralibolnik.

Estemanualdeserviciosóloexisteeninglés.

•Sielencargadodemantenimientodeunclientenecesitaunidiomaquenoseaelinglés,el

clientedeberáencargarsedelatraduccióndelmanual.

•Nosedeberádarserviciotécnicoalequipo,sinhaberconsultadoycomprendidoeste

manualdeservicio.

•Lanoobservanciadelpresenteavisopuededarlugaraqueelproveedordeservicios,el

operadoroelpacientesufranlesionesprovocadasporcausaseléctricas,mecánicaso
deotranaturaleza.

Denhärservicehandbokennnsbaratillgängligpåengelska.

•Omenkundsserviceteknikerharbehovavettannatspråkänengelskaansvararkunden

föratttillhandahållaöversättningstjänster.

•Försökinteutföraservicepåutrustningenomduinteharlästochförstårdenhär

servicehandboken.

•Omduintetarhänsyntilldenhärvarningenkandetresulteraiskadorpåserviceteknikern,

operatörenellerpatiententillföljdavelektriskastötar,mekaniskafarorellerandrafaror.

Buserviskılavuzununsadeceİngilizcesimevcuttur .

•Eğermüşteriteknisyenibukılavuzuİngilizcedışındabirbaşkalisandantalepederse,bunu

tercümeettirmekmüşteriyedüşer.

•Serviskılavuzunuokuyupanlamadanekipmanlaramüdahaleetmeyiniz.

•Buuyarıyauyulmaması,elektrik,mekanikveyadiğertehlikelerdendolayıteknisyen,

operatörveyahastanınyaralanmasınayolaçabilir.

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ServiceManualLanguageInformation(cont'd.)

ЗАСТЕРЕЖЕННЯ
(UK)

CẢNHBÁO
(VI)

Данекерівництвозсервісногообслуговуванняпостачаєтьсявиключноанглійськоюмовою.

•Якщосервіснийінженерпотребуєкерівництвоіншоюмовою,користувачзобов'язаний

забезпечитипослугиперекладача.

•Ненамагайтесяздійснюватитехнічнеобслуговуванняданогообладнання,якщо

винечитали,абонезрозумілиінформацію,наданувкерівництвізсервісного
обслуговування.

•Недотриманняцьогозастереженняможепризвестидотравмуваннясервісного

інженера,користувачаданогообладнанняабопацієнтавнаслідокелектричногошоку,
механічногоушкодженняабозіншихпричинневірногообслуговуванняобладнання.

TàiLiệuHướngDẫnSửaChữachỉcóbảntiếngAnh.

•Nếucácđơnvịcungcấpdịchvụchokháchhàngyêucầumộtngônngữnàokháctiếng

Anh,thìkháchhàngsẽcótráchnhiệmcungcấpcácdịchvụdịchthuật.

•KhôngđượcsửachữathiếtbịtrừkhiđãthamkhảovàhiểuTàiliệuHướngdẫnSửachữa.

•Khôngtuânthủnhữngcảnhbáonàycóthểdẫnđếncáctổnthươngchongườithực

hiệnsửachữa,ngườivậnhànhhaybệnhnhân,dosốcđiện,cácrủirovềcơkhíhay
cácrủirokhác.

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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

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9

ArchitectureandTheoryofOperation......................................................40

3ServiceSetup

AccessingServiceSetup............................................................................43

DeviceSettings.........................................................................................44

EventLog..................................................................................................44

SystemDiagnostics...................................................................................46

Keypads................................................................................................37

BlockDiagram........................................................................................40

Hardware/FirmwareArchitecture.................................................................42

ProductInterfaces....................................................................................42

SettingUpEventLogging...........................................................................45

ExportingtheEventLog.............................................................................46

TestingtheDisplay...................................................................................47

TestingtheSpeaker..................................................................................49

TestingtheKeypad...................................................................................50

TestingtheAcquisitionModule....................................................................51

CheckingtheBatteryStatus........................................................................51

TestingtheWriter....................................................................................52

CommunicationsTests..............................................................................55

TestingthePatientLeadwires......................................................................59

PrintingaServiceReport............................................................................60

4Maintenance

UpdatingtheSoftware..............................................................................60

FormatingtheFlashMemory....................................................................68

OpeningaCommandPrompt....................................................................70

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

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5Troubleshooting

ECGDataNoise.......................................................................................135

GeneralFaultIsolation............................................................................136

ErrorCodes.............................................................................................138

6PartsList

PartIdentication...................................................................................141

FRULists..................................................................................................152

PowerUpSelfTest..................................................................................136

VisualInspection....................................................................................137

EventLogging.......................................................................................138

DiagnosticTests....................................................................................138

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

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GuidanceandManufacturer’sDeclaration—Electromagnetic

Immunity.................................................................................................167

RecommendedSeparationDistances.....................................................170

CTechnicalSpecications

SystemSpecications.............................................................................171

Acquisition,Processing,andPerformance..............................................173

OperatingModes,Features,andOptions...............................................175

DWiFiCountryList

AllowableChannels.................................................................................177

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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.

1

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.

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MAC™2000ECGAnalysisSystem

13

Introduction

Contraindications

Thissystemisnotintendedforuseinthefollowingmanner:

•Duringpatienttransport

•Withhigh-frequencysurgicalunits

•Asanintra-cardiacapplication

•Asavitalsignsphysiologicalmonitor

PrescriptionDeviceStatement

CAUTION:

UnitedStatesfederallawrestrictsthisdevicetosalebyorontheorderofa
physician.

RegulatoryandSafetyInformation

SafetyConventions

Thissectionprovidesinformationaboutthesafeuseandregulatorycomplianceof
thissystem.Familiarizeyourselfwiththisinformation,andreadandunderstandall
instructionsbeforeattemptingtousethissystem.Thesystemsoftwareisconsidered
medicalsoftware.Assuch,itwasdesignedandmanufacturedtotheappropriate
medicalregulationsandcontrols.

NOTE:

Disregardingthesafetyinformationprovidedinthismanualisconsidered
abnormaluseofthissystemandcouldresultininjury,dataloss,oravoided
warranty.

AHazardisasourceofpotentialinjurytoaperson,property,orthesystem.
ThismanualusesthetermsDANGER,WARNING,CAUTION,andNOTICEtopointout

hazardsandtodesignateadegreeorlevelofseriousness.Familiarizeyourselfwith
thefollowingdenitionsandtheirsignicance.

DenitionsofSafetyConventions

Safety
Convention

DANGER

WARNING

CAUTION

NOTICE

Denition

Indicatesanimminenthazard,which,ifnotavoided,willresultindeath
orseriousinjury.

Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultindeathorseriousinjury.

Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinmoderateorminorinjury.

Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinthelossordestructionofpropertyordata.

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MAC™2000ECGAnalysisSystem

2053535-003C

SafetyHazards

Thefollowingmessagesapplytothesystemasawhole.Specicmessagesmayalso
beprovidedelsewhereinthemanual.

WARNING:

WARNING:

WARNING:

Introduction

EQUIPMENTMALFUNCTION—Anyattemptbyunauthorizedpersonneltoservice
thedevicecouldresultinequipmentmalfunctionandvoidthewarranty.

Thisequipmentcontainsnouser-serviceableparts.Referservicingtoauthorized
servicepersonnel.

PATIENTINJURY–STRANGULATION—Cablespresentapossiblestrangulation
hazard.

Toavoidpossiblestrangulation,routeallcablesawayfromthepatient’sthroat.
Useashortversionofcableforpediatricpatients.

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.

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MAC™2000ECGAnalysisSystem

15

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.

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2053535-003C

NOTE:

Followtheinstructionsprovided.Donotpositionequipmentinawaythatmakesit
difculttodisconnectthedevicewhenusinganappliancecoupler,mainsplug,or
otherseparableplugasameansofisolation.

ClassicationofMedicalDevice

Thedeviceisclassiedasfollows,accordingtoIEC60601-1:

MedicalDeviceClassications

Introduction

Category

Typeofprotectionagainstelectrical
shock

Degreeofprotectionagainstelectrical
shock

DegreeofprotectionagainstsolidsTheIPcodeforthisdeviceisIP20.

Degreeofprotectionagainstharmful
ingressofliquids(IP20)

Degreeofsafetyofapplicationinthe
presenceofammableanesthetic
mixturewithairorwithoxygenorwith
nitrousoxide

Method(s)ofsterilizationordisinfection
recommendedbythemanufacturer

Classication

ClassIinternallypoweredequipment

TypeCFdebrillation-proofappliedpart

Protectedagainstsolidforeignobjectswitha
diameterof12.5mmandgreater

Theobjectprobe,asphere12.5mmdiameter,
shallnotfullypenetrate.Thejointedtestnger
12mmdiameter,80mmlength,shallhave
adequateclearancefromhazardousparts.

TheIPcodeforthisdeviceisIP20.
Non-protected
Thisdeviceisordinaryequipment(enclosed

equipmentwithoutprotectionagainstingress
ofliquids)

Equipmentisnotsuitableforuseinthepresence
ofaammableanestheticmixturewithairor
withoxygenorwithnitrousoxide

Notapplicable

CerticationInformation

RecordingECGsDuringDebrillation

Thisequipmentisprotectedagainsttheeffectsofcardiacdebrillatordischarge
toensurerecovery,asrequiredbyteststandards.Thepatientsignalinputofthe
acquisitionmoduleisdebrillation-proof.Therefore,itisnotnecessarytoremove
theECGelectrodespriortodebrillation.

2053535-003C

Modeofoperation

MedicalEquipment

Withrespecttoelectricshock,re,andmechanicalhazardsonlyin
accordancewithUL60601–1,andCAN/CSAC22.2NO.601.1.

MAC™2000ECGAnalysisSystem

Continuousoperation

17

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

18

MAC™2000ECGAnalysisSystem

2053535-003C

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.

Introduction

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

2053535-003C

YoushoulduseonlysuppliesandaccessoriesthatGEHealthcarerecommends.For
alistofrecommendations,refertothesuppliesandaccessoriesreferenceguide
forthissystem

ContactGEHealthcarebeforeusinganythingthatisnotrecommendedforthissystem.

MAC™2000ECGAnalysisSystem

19

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

HardwareLabelLocations

Thissectionidentiesthefollowing:

•Hardwarelabelsandtheirlocationsonpage20

•SymbolDescriptionsonpage21

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MAC™2000ECGAnalysisSystem

2053535-003C

Introduction

Item

Label

1

2

3

4

LocationDescription

BackofthedeviceProductLabel

Identiesthisdevice.See

“ProductLabel”onpage29

foradescriptionofthelabel
contents.

BackofthedeviceDeviceAddressLabeland

RatingPlate
Itprovidesregulatoryand
cautionaryinformation.See

“DeviceAddressLabeland
RatingPlate”onpage30for

anexplanationofthelabel.

BottomcoverofthedeviceTheOptionCodelabel.

Usetheoptioncodes
tosetupthepurchased
optionsinyoursystem.

Usetheoptioncodes
tosetupthepurchased
optionsinyoursystem.

Referto“OptionsSetup”in
theoperatormanual.

OntheshippingpackageEnvironmentalsymbols

requiredforshipping.

5

6

OntheshippingpackageBatteryShippingLabel.

FRAGILE—LithiumIon
batteriescancausereif
damaged.

OntheshippingpackageTheshippinglabel.

SymbolDescriptions

Thefollowingtabledescribessymbolsoriconsthatmaybeonthedeviceorits
packaging.Notallofthesymbolsdenedinthetableapplytoyourdeviceorits
packaging.

Symbolsareusedtoconveywarnings,cautions,prohibitions,mandatoryactions,
orinformation.Anysymbolonyourdeviceorpackagingwithmarkingsincolor
indicatestheremaybeadanger,warning,ormandatoryaction.Anysymbolonyour
deviceorpackagingthatisinblackandwhiteprovidesadditionalinformationormay

2053535-003C

MAC™2000ECGAnalysisSystem

21

Introduction

indicateacaution.Familiaritywiththesesymbolsassistsintheuseanddisposal
oftheequipment.

Forequipmentsymbolsnotshown,refertotheoriginalequipmentmanufacturer
(OEM)manuals.

SymbolDescriptions

Symbol

Description
CatalogorOrderablePartNumber

Indicatesthemanufacturer'scatalogorpartnumber.

SerialNumber

Indicatesthemanufacturer'sserialnumber.

BatchCodeorLotNumber

Indicatesthemanufacturer'sbatchcodeorlotnumber .

DateofManufacture(Year-Month)
Indicatestheoriginalmanufacturedateforthisdevice.

Manufacturer

Indicatesthenameandaddressforthemanufacturerofthisdevice.It
mayalsoincludethedateitwasmanufactured.

AuthorizedRepresentativeintheEuropeanCommunity

Indicatesthenameandaddressoftheauthorizedrepresentativeinthe
EuropeanCommunityforthisdevice.

RxOnly

USFederallawrestrictsthisdevicetosalebyorontheorderofa
physician.

12SL

IndicatesthedeviceusestheMarquette™12SLECGAnalysisProgram
toanalyzeandinterpretECGreadings.

IPxy

22

IPCode(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.

MAC™2000ECGAnalysisSystem

2053535-003C

SymbolDescriptions(cont'd.)

Introduction

Symbol

Description
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.

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.

2053535-003C

MAC™2000ECGAnalysisSystem

23

Introduction

SymbolDescriptions(cont'd.)

Symbol

Description

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.

WARNING:

HANDCRUSHINGHAZARD
Thisdevicecontainsmovingpartsthatcouldcrushtheuser'shand.

Keephandsclearofthedevicewhileitisinoperation.Disconnect
powerbeforereachingintoorservicingthedevice.

Asawarningsign,thissymbolisidentiedbyayellowbackground,black
triangularband,andablacksymbol.

WARNING:

BODILYINJURY
Indicatesthepresenceofasharpedgeorobjectthatcancause
cutsorotherbodilyinjury.

Topreventcutsorotherbodilyinjury,donotcontactsharpedgeof
object.

Asawarningsign,thissymbolisidentiedbyayellowbackground,black
triangularband,andablacksymbol.

24

MAC™2000ECGAnalysisSystem

2053535-003C

SymbolDescriptions(cont'd.)

Introduction

Symbol

Description

WARNING:

BODILYINJURY
Indicatesthepresenceofapotentialtip-overhazardthatcanresult
inbodilyinjury.

Toavoidriskofbodilyinjury,followallinstructionsformaintaining
thestabilityoftheequipmentduringtransport,installation,and
maintenance.

Asawarningsign,thissymbolisidentiedbyayellowbackground,black
triangularband,andablacksymbol.

WARNING:

PINCHPOINT
Thisdevicecontainsmovingpartsthatcouldpinchbodyparts.

Keephandsclearofthedevicewhileitisinoperation.Disconnect
thepowerbeforereachingintoorservicingthedevice.

Asageneralprohibitionsign,thissymbolisidentiedbyawhite
background,redcircularbandandslash,andablacksymbol.

WARNING:

PERSONALINJURYDONOTREACHIN
Reachingintotheequipmentcancausepersonalinjury.

Donotplacehandsintoanyopenings.

Asageneralprohibitionsign,thissymbolisidentiedbyawhite
background,redcircularbandandslash,andablacksymbol.

WARNING:

ENVIRONMENTALORHEALTHHAZARD
Incineratingthedeviceorproductcouldpresentarisktothe
environmentorhumanhealth.

Donotincineratethisdeviceorproduct.

Asageneralprohibitionsign,thissymbolisidentiedbyawhite
background,redcircularbandandslash,andablacksymbol.

WARNING:

BREAKAGEDUETOHEAVYLOAD
Heavyobjectsonthesurfacemaycauseittobreak.

Donotloadobjectsheavierthanthemaximumpermissibleload
indicatedforasafeworkingload.

Asageneralprohibitionsign,thissymbolisidentiedbyawhite
background,redcircularbandandslash,andablacksymbol.

CanBeRecycled

Indicatesyoumayrecyclethismaterialordevice.Recycleordisposeof
inaccordancewithlocal,state,orcountrylaws.

2053535-003C

MAC™2000ECGAnalysisSystem

25

Introduction

SymbolDescriptions(cont'd.)

Symbol

Description
WasteElectricalandElectronicEquipment(WEEE)

Indicatesthisequipmentcontainselectricalorelectroniccomponents
thatmustnotbedisposedofasunsortedmunicipalwastebutcollected
separately.Contactanauthorizedrepresentativeofthemanufacturer
forinformationconcerningthedecommissioningofyourequipment.

Contains<heavymetalchemicalsymbol>

Indicatesthisequipmentcontainsheavymetalandmustnotbe
disposedofasunsortedmunicipalwastebutcollectedseparately.
TheexampleshowsLithiumIon.

EnvironmentalFriendlyUsePeriod(EFUP)

PerChinesestandardSJ/T11363–2006,indicatesthenumberofyears
fromthedateofmanufactureduringwhichyoucanusetheproduct
beforeanyrestrictedsubstancesarelikelytoleak,causingapossible
environmentalorhealthhazard.

NOTE:

•Ifthedevicecontainslessthanthemaximumconcentrationof
restrictedsubstances,thesymbolcontainsalowercasee

•ThisisalsoreferredtoasChinaRoHS.

JapanRoHS

Indicatesthedeviceorproductmeetstheregulationslimitorbanfor
specicsubstancesinnewelectronicandelectricequipmentinJapan.
TheGreenMark(withtheG)indicatestheproductiswithinthe
tolerancesofhazardouschemicals.
TheContentMark(withtheRandlettersbelow)indicateswhich
hazardoussubstance(s)wasusedduringthemanufacturingofthe
electricalorelectronicequipmentthatexceedsmaximumtolerances.

Fragile

Indicatesthecontentsarefragile.Handlewithcare.

ThisWayUp

Indicatesthecorrectuprightpositionofthepackage.

DoNotStack

Indicatesthatyoushouldnotstackthecontainerorplacealoadon
thecontainer.

KeepDry

Indicatesthatyouneedtokeepthecontainerawayfromrainandother
sourcesofmoisture.

26

MAC™2000ECGAnalysisSystem

2053535-003C

SymbolDescriptions(cont'd.)

Introduction

Symbol

Description
HumidityLimits

Indicatesupperandlowerhumiditylimitsforthetransportationand
handlingofthispackage.Theyareindicatednexttotheupperand
lowerhorizontallines.

AtmosphericLimits

Indicatestheupperandlowerbarometricpressurelimitationsforthe
transportationandhandlingofthispackage.Theyareindicatednextto
theupperandlowerhorizontallines.

UpperTemperatureLimit

Indicatesthemaximumtemperaturefortransportationandhandlingof
thispackage.Thelimitisindicatednexttotheupperhorizontalline.

TemperatureLimits

Indicatestheupperandlowertemperaturelimitsforthetransportation
andhandlingofthispackage.Theyareindicatednexttotheupper
andlowerhorizontallines.

Thefollowingtabledescribescerticationsymbolsthatmaybeusedonyourdevice
oritspackaging.Theinclusionofasymbolinthistabledoesnotindicatethatyour
productwascertiedbythatsymbol’sgoverningbodyandislistedforreference
only.Toidentifywhichorganizationshavecertiedyourdevice,refertothelabeling
onyourdeviceoritspackaging.

Certication
Symbol

Description

ULMark

IndicatescompliancewithapplicableUnderwritersLaboratories
requirements.

ULListedMark

Indicatescompliancewithinternationalorregionalstandardsfor
UnderwritersLaboratoriessafetyrequirements.

ULListed,Canada/US

Indicatescompliancewithinternationalorregionalstandardsfor
UnderwritersLaboratoriessafetyrequirementsinCanadaandthe
UnitedStates.

ULClassicationMark

IndicatesthismedicalequipmentisULClassiedwithrespectto
electricshock,re,andmechanicalhazardsonlyinaccordancewithUL
60601-1,CAN/CSAC22.2NO.601.1,andIEC60601-2-25.

ULClassicationMark,Canada/US

IndicatesthismedicalequipmentisULClassiedwithrespectto
electricshock,re,andmechanicalhazardsonlyinaccordancewith
UL60601-1,CAN/CSAC22.2NO.601.1,andIEC60601-2-25forthe
USandCanada.

2053535-003C

MAC™2000ECGAnalysisSystem

27

Introduction

Certication
Symbol

Description

CEMark

IndicatesthedeviceorproductconformswithapplicableEU(European
Union)directives.

PCT(GOST-R)Mark

IndicatesthedeviceorproductconformswithapplicableRussian
Gosstandarttechnicalandsafetystandards.

NRTLCertication

IndicatesthedeviceorproducthasmettheNationalRecognized
TestingLaboratoriescertication.
TheNRTLcerticationattaintedisaddedtothemarkoftheapplicable
testinglaboratory.TheexampledisplaystheNRTLcerticationwith
theMETLaboratoriesmark.

ChinaMetrologyCertication

IndicatesthedeviceorproductcomplieswithapplicableChina
MetrologyCerticationrequirements.

TÜVRheinland

Indicatesthedeviceorproductcomplieswithapplicabletechnical
andsafetyrequirementsfollowingtestingbyTechnischer
Überwachungs-Verein,(TechnicalInspectionsOrganization).

Training

Thismanualisintendedasasupplementto,notasubstitutefor,thoroughproduct
training.Ifyouhavenotreceivedtrainingontheuseofthesystem,youshouldrequest
trainingassistancefromGEHealthcare.

Toseeavailabletraining,gototheGEHealthcaretrainingWeb
site(www.gehealthcare.com/training

).SelectEducation>Product

Education-Technical>DiagnosticCardiology.
Formoreself-pacedcourseofferings,tools,andreferenceguidesyou

maynduseful,pleasevisittheGEHealthcareEducationStoreat

www.gehealthcare.com/educationstore

.

EquipmentIdentication

EveryGEHealthcareproducthasaproductlabelthatidentiestheproductname,
partnumber,manufacturinginformation,anduniqueserialnumber.Thisinformation
isrequiredwhencontactingGEHealthcareforsupport.

28

MAC™2000ECGAnalysisSystem

2053535-003C

ProductLabel

Introduction

Theproductlabelislaidoutinthefollowingformat.Dependingontheproduct,the
labelmayvaryslightlyinformat,butitcontainsthesameinformation.

ProductLabelFormat

SerialNumberFormat

Item

1
2
3
4
5

Description

Productdescription
Productpartnumber
Deviceserialnumber(See“SerialNumberFormat”onpage29formoreinformation.)
Productbarcode
DateofmanufactureinYYYY-MMformat

Eachdevicehasaserialnumberthatuniquelyidentiesitandprovidesimportant
information.Youneedtheproductcodeandtheentireserialnumberbeforeservicing
orrequestingsupportforyourproduct.Theserialnumberformatisshowninthe
followingillustration:

SerialNumberFormat

ItemName

1

2

3

4

2053535-003C

ProductCodeThree-lettercodethatuniquelyidentiestheproductline.

YearManufacturedTwo-digitcodeidentifyingtheyearthedevicewas

FiscalWeek
Manufactured

ProductSequenceFour-digitnumberidentifyingtheorderinwhichthis

MAC™2000ECGAnalysisSystem

Description

See“ProductCodes”onpage30formoreinformation.

manufactured.Valuesrangefrom00to99
Forexample:00=2000,04=2004,05=2005(andsoon).

Two-digitcodeidentifyingtheweekthedevicewas
manufactured.
Valuesrangefrom01to52.GEHealthcare'sscalweeks
correspondtothecalendarweek.Forexample,01=rst
weekinJanuary.

devicewasmanufactured.Valuesrangefrom0001to

9999.

29

Introduction

SerialNumberFormat(cont'd.)

ItemName

5

6

ManufacturingSiteOne-lettercodeidentifyingthesitewherethedevicewas

Miscellaneous
Characteristic

Description

manufactured.Forexample,F=Milwaukee,N=Freiburg,
P=Bangalore

Forexample,P=deviceisaprototype,R=devicewas
refurbished,U=devicewasupgradedtomeetthe
specicationsofanotherproductcode,A=deviceisin
production.

DeviceAddressLabelandRatingPlate

TheDeviceAddresslabelandRatingPlateislaidoutinthefollowingformat.
Dependingontheproduct,thelabelmayvaryslightlyinformat.

Item

1
2
3

4
5

Description

Productdescription
Countryoforigin
Symbols

See“SymbolDescriptions”onpage21foradescriptionofthesymbolsusedon
thislabel.

Electricalratingofthedevice
Manufacturernameandaddress

ProductCodes

30

Theproductcodeidentiesspecicsystemplatforms.
Youcanidentifytheproductcodeusingtheserialnumberlistedontheproductlabel

locatedinoneofthefollowingplaces:

•Ontheproductlabelattachedtothedevice.

•OntheproductlabelprovidedwiththeapplicationCD.

Forsoftwareapplicationsystems,youcanviewtheserialnumberbylaunchingthe
systemapplicationandclickingHelp>About.

Forinformationonlaunchingtheapplication,refertotheserviceoroperator'smanual
forthissystem.

MAC™2000ECGAnalysisSystem

2053535-003C