GE OptimaEMS_Service_Manual_SM_2061274-003_B Optima EMS ECG Management System Service Manual 2061274-003 Revision B

GEHealthcare

OptimaEMS

ECGManagementSystem
ServiceManual

2061274-003RevisionB

OptiamEMS
English
©GeneralElectricCompany.
AllRightsReserved.

PublicationInformation

TheinformationinthismanualappliesonlytoOptimaEMSECGManagementSystemVersion1.0.Itdoesnotapplytoearlierproduct
versions.Duetocontinuingproductinnovation,specicationsinthismanualaresubjecttochangewithoutnotice.

MUSE,MAC,andMarquettearetrademarksownedbyGEMedicalSystemsInformationTechnologies,Inc.,aGeneralElectricCompanygoing
tomarketasGEHealthcare.Allothertrademarkscontainedhereinarethepropertyoftheirrespectiveowners.

Thedocumentpartnumberandrevisionappearatthebottomofeachpage.Therevisionidentiesthedocument’supdatelevel.The
revisionhistoryofthisdocumentissummarizedinthefollowingtable.

Revision

A

B

ToaccessotherGEHealthcaremanuals,gototheCommonDocumentationLibrary(CDL),locatedathttp://www.gehealthcare.com/usen/

service/biomed_tech_selfservice/services_user_doc/products/support.htmlandclickCardiology.

ToaccessOriginalEquipmentManufacturer(OEM)manuals,gotothedevicemanufacturer'sWebsite.

Date

March27,2012InternalRelease

Nov11,2012

Comments

InitialCustomerRelease

ServiceManualLanguageInformation

WARNING
(EN)

ПРЕДУПРЕЖДЕНИЕ
(BG)

警告

ZH-CN

警告

(ZH-TW)

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。

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。

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ServiceManualLanguageInformation(cont'd.)

UPOZORENJE
(HR)

VAROVÁNÍ
(CS)

ADVARSEL
(DA)

WAARSCHUWING
(NL)

HOIATUS
(ET)

VAROITUS
(FI)

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.

Tämähuolto-ohjeonsaatavillavainenglanniksi.

•Josasiakkaanhuoltohenkilöstövaatiimuutakuinenglanninkielistämateriaalia,tarvittavan

käännöksenhankkiminenonasiakkaanvastuulla.

•Äläyritäkorjatalaitteistoaennenkuinoletvarmastilukenutjaymmärtänyttämän

huolto-ohjeen.

•Mikälitätävaroitustaeinoudateta,seurauksenavoiollahuoltohenkilöstön,laitteiston

käyttäjäntaipotilaanvahingoittuminensähköiskun,mekaanisenviantaimuun
vaaratilanteenvuoksi.

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ServiceManualLanguageInformation(cont'd.)

ATTENTION
(FR)

WARNUNG
(DE)

ΠΡΟΕΙΔΟΠΟΙΗΣΗ
(GR)

FIGYELMEZTETÉS
(HU)

AÐVÖRUN
(IS)

PERINGATAN
(ID)

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.

ManualservisinihanyatersediadalambahasaInggris.

•JikapenyediajasaservispelangganmemerlukanbahasalainselaindariBahasaInggris,

merupakantanggungjawabdaripenyediajasaservistersebutuntukmenyediakan
terjemahannya.

•Janganmencobamelakukanservisterhadapperlengkapankecualitelahmembacadan

memahamimanualservisini.

•Mengabaikanperingataninibisamengakibatkancederapadapenyediaservis,operator,

ataupasien,karenaterkenakejutlistrik,bahayamekanisataubahayalainnya.

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ServiceManualLanguageInformation(cont'd.)

AVVERTENZA
(IT)

警告

(JA)

경고

(KO)

BRĪDINĀJUMS
(LV)

ĮSPĖJIMAS
(LT)

ADVARSEL
(NO)

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.

Denneservicehåndbokennnesbarepåengelsk.

•Hviskundensserviceleverandørtrengeretannetspråk,erdetkundensansvaråsørge

foroversettelse.

•Ikkeforsøkåreparereutstyretutenatdenneservicehåndbokenerlestogforstått.

•Manglendehensyntildenneadvarselenkanføretilatserviceleverandøren,operatøren

ellerpasientenskadespågrunnavelektriskstøt,mekaniskeellerandrefarer.

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ServiceManualLanguageInformation(cont'd.)

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.

UPOZORENJE
(SR)

Ovoservisnouputstvojedostupnosamonaengleskomjeziku.

•Akoklijentovserviserzahtevanekidrugijezik,klijentjedužandaobezbediprevodilačke

usluge.

•Nepokušavajtedaopraviteuređajakonistepročitaliirazumeliovoservisnouputstvo.

•Zanemarivanjeovogupozorenjamožedovestidopovređivanjaservisera,rukovaocaili

pacijentausledstrujnogudara,ilimehaničkihidrugihopasnosti.

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ServiceManualLanguageInformation(cont'd.)

VAROVANIE
(SK)

OPOZORILO
(SL)

ADVERTENCIA
(ES)

VARNING
(SV)

UYARI
(TR)

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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Nov11,2012

Contents

1Introduction

IntendedUse.............................................................................................13

IntendedUser............................................................................................13

Contraindications.....................................................................................13

SystemAccuracy.......................................................................................13

RegulatoryandSafetyInformation...........................................................14

SafetyConventions..................................................................................14

SafetyHazards........................................................................................14

GeneralSafetyRequirements......................................................................15

ResponsibilityofthePurchaser/Customer.......................................................15

ProductandPackagingInformation..............................................................15

Training.....................................................................................................23

EquipmentIdentication...........................................................................23

ProductLabel.........................................................................................24

SerialNumberFormat...............................................................................24

ProductCodes........................................................................................25

ServiceInformation...................................................................................26

ServiceRequirements...............................................................................26

Customer-suppliedHardware......................................................................26

SecurityUpdates.....................................................................................26

AdditionalAssistance................................................................................26

ManualInformation..................................................................................27

IntendedAudience...................................................................................27

ManualPurpose......................................................................................27

DocumentConventions.............................................................................27

RelatedDocuments...................................................................................28

2ProductOverview

GeneralOperation....................................................................................29

DataAcquisition........................................................................................29

DeviceInterfaces......................................................................................30

MACCarts..............................................................................................30

MARS....................................................................................................31

CASE/CardioSoftStressSystems..................................................................31

HL7Interface............................................................................................31

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9

HL7Inbound...........................................................................................32

HIS/EMROutbound....................................................................................32

OptionalFeatures.....................................................................................33

Specications............................................................................................34

HardwareSpecications............................................................................34

SoftwareSpecications.............................................................................35

OptimaEMSDriveContentsandSupportingFolders................................36

OptimaEMSServices.................................................................................36

RequiredNetworkPorts............................................................................36

3SystemAdministration

RemoteDatabases....................................................................................37

SQLPorts...............................................................................................37

SQLRemoteConnections...........................................................................38

Installing/Uninstalling/Upgrade...............................................................38

InstallingtheOptimaEMSSystem.................................................................38

UninstallingtheOptimaEMSSystem.............................................................52

UpgradingtheOptimaEMSSystem...............................................................57

4Maintenance

MaintenanceGuidelines............................................................................59

OEMMaintenance....................................................................................59

FunctionalCheckoutProcedures..............................................................60

Non-FRURepairs.....................................................................................60

5OptimaEMSSystemBackupandRecovery

Introduction..............................................................................................65

BackupandRecoveryoftheDatabase.....................................................65

BackingUpandRecoveringtheDatabaseManually..........................................65

BackingUpandRecoveringtheDatabaseUsingSQLServerTools.........................66

AdditionalInformation..............................................................................66

SystemShutdownandRestartProcedure.......................................................66

InitializingaNewTape...............................................................................67

AProductSpecication

StorageEnvironmentalRequirements......................................................69

FunctionalLimitations..............................................................................69

HardwareSpecications...........................................................................71

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SoftwareSpecications.............................................................................71

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11

12

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Introduction

IntendedUse

1

ThisdocumentdescribestheOptimaEMSECGManagementSystem,alsoreferred
toas“thesystem”.

Thischapterprovidesgeneralinformationrequiredfortheproperuseofthesystem
andthemanual.Familiarizeyourselfwiththisinformationbeforeusingthesystem.

Thesystemisintendedto:

•Providecentralizestorageandmanagementforelectrocardiographinformationin
ahospitalsetting;

•Providetheabilitytoreviewelectrocardiographrecords;

•Providereporttemplatesforelectrocardiographreportreviewingandeditingfor
physicians;

IntendedUser

Contraindications

SystemAccuracy

2061274-003B

•ProvidetheabilitytoqueryandgeneratestatisticsforECGdata.

Thesystemisasoftware-onlyproduct.Theusershouldhaveexperienceworking
onaPCcomputer.

Thefollowingcontraindicationsapplytothissystem:

•Thesystemdoesnothavediagnosticfunctionality.

•Thesystemisnotintendedforreal-timepatientmonitoring.

•Thesystemisnotintendedforthetransferoftime-sensitivedata.

Accuracyofthesystemis100%datareproduction,dependentonzoomsettings,and
theresolutionofthedisplayand/orprinteryouareusing.

OptimaEMS

13

Introduction

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

SafetyHazards

Thefollowingmessagesapplytothesystemasawhole.Specicmessagesmayalso
beprovidedelsewhereinthemanual.

Safety
Convention

DANGER

WARNING

CAUTION

NOTICE

NOTICE:

Changingsettingswithoutknowinghowtheyaffectthesystemcancauselossofdata.
Donotchangeanycurrentsettingsunlessyouunderstandhowthechangeaffectsthe
system.

Denition

Indicatesanimminenthazard,which,ifnotavoided,willresultindeath
orseriousinjury.

Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultindeathorseriousinjury.

Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinmoderateorminorinjury.

Indicatesapotentialhazardorunsafepractice,which,ifnotavoided,
couldresultinthelossordestructionofpropertyordata.

NOTICE:

InstallationofsoftwarenotspeciedbyGEHealthcaremaycausedamagetothe
equipment,lossorcorruptionofdata.DONOTloadanysoftwareotherthanthat
speciedbyGEHealthcareontothesystem.

14

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GeneralSafetyRequirements

Thedeviceorsystemislabeledundertheoriginalequipmentmanufacturer’slabel(for
example,UL,CEEULVD2006/95/EC)anddeemedsufcientbyGEHealthcaretobe
incompliancewithEN/IEC60601-1(clause3.201.2foruseofnon-medicaldevices
inamedicalsystem),whenusedaccordingtothedeviceorsystem’sintendeduse.
HardwaresuppliedbyGEHealthcaremeetstheapplicablecountryrequirementsfor
InformationTechnologyEquipment(ITE).

InformationTechnologyEquipmentRequirements

Thehardwarecomponentsofthesystemarenotconsideredmedicalequipment.
TheyareconsideredInformationTechnologyEquipment(ITE).Thesystem’sindividual
componentscomplywiththestandardsforSafetyofInformationTechnology
Equipment(forexample,UL60950-1,EN/IEC60950-1).

Ifyouusethesysteminapatient’svicinity,itmustcomplywiththestandard
requirementsformedicalsystems(thatis,EN/IEC60601-1).

•Tocomplywiththisstandard,youmustconnectthecomponentsandallattached
accessoriestoamedicalgrade(EN/IEC60601-1)powersource(forexample,
MedicalgradeUPSorIsolationTransformer).

Introduction

•SystemInputs/Outputsconnectedtonon-medicalequipmentmustalsobeisolated
foroverallsystemcompliance.

•Patientvicinityisdenedasaspace,withinalocationintendedfortheexamination
andtreatmentofpatients,extending1.83m(6ft.)beyondthenormallocationof
thebed,chair ,table,treadmill,orotherdevice(s)supportingthepatientduring
examinationandtreatment,andextendingverticallyto2.5m(8ft.2.4in.)above
theoor .

Inaddition,anynon-medicalelectricalequipmentthatyouusewiththesystem
(outsidethepatientvicinity)mustcomplywithapplicablesafetystandardsforthat
equipment(thatis,EN/IEC60950-1).

NOTE:

IftheequipmentisinstalledintheU.S.A.using240Vratherthan120V,thesource
mustbeacenter-tapped,240V,single-phasecircuit.

ResponsibilityofthePurchaser/Customer

Thecustomerisresponsibleforprovidingappropriatedesks,chairs,electricalwall
outlets,networkconnections,andanalogphonelines,andforlocatinganyofthe
systemcomponentsdescribedinthismanualincompliancewithalllocal,state,and
nationalcodes.

ProductandPackagingInformation

Thissectionidentiesthelabels,indicatestheirlocationsontheproductandits
packaging,anddescribesthesymbolsused.See“SymbolDescriptions”onpage16for
detaileddescriptionsofthesymbolsusedontheselabels.

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15

Introduction

SoftwareLabelLocations

ThefollowingillustrationandtabledescribethelabelonyourCDorDVD.

NOTE:

TheSerialNumberislocatedonthejewelcaseofyourCDorDVD.

DescriptionsofCD/DVDLabel

Item

1
2
3
4
5
6
7
8

Description

ProductName
SoftwareModel
CopyrightNotice
SoftwareVersion
SerialNumber
PartNumber
Revision
DateofManufacture

SymbolDescriptions

Thefollowingtabledescribessymbolsoriconsthatmaybeonthedeviceorits
packaging.Notallofthesymbolsdenedinthetableapplytoyourdeviceorits
packaging.

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2061274-003B

Introduction

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

12SL

IndicatesthedeviceusestheMarquette™12SLECGAnalysisProgramto
analyzeandinterpretECGreadings.

ConsultInstructionsforUse

Consulttheoperatinginstructions.

NoUser–orField-serviceableParts

Donotopenordisassemblethedeviceforanyreason.

ClassIIEquipment

Identiesequipmentthatmeetsthesafetyrequirementsspeciedfor
classIIequipmentbyIEC60601–1.
Thisdevicewasdesignedsothatitdoesnotrequireasafetyconnection
toelectricalearth(USground).Nosinglefailureresultsindangerous
voltagebecomingexposedandcausinganelectricshock.Thisis
achievedwithoutrelyingonanearthedmetalcasing.

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OptimaEMS

17

Introduction

SymbolDescriptions(cont'd.)

Symbol

IPxy

Description

Debrillation-proofTypeBFAppliedPart

Identiesadebrillation-prooftypeBFappliedpartonmedical
equipmentthatcomplieswithIEC60601–1.
Thisdevicemeetstherequirementsforprotectionagainstelectricshock
foranearth-free(oating)appliedpart(oneintendedforcontactwith
patients).

Debrillation-proofTypeCFAppliedPart

Identiesadebrillation-prooftypeCFappliedpartonmedical
equipmentthatcomplieswithIEC60601–1.
Thisdevicemeetstherequirementsforprotectionagainstelectricshock
foranearth-free(oating)appliedpart(oneintendedforcontactwith
patients)forcardiacapplication.

IPCode(IngressProtectionRating)

Classiesandratesthedegreeofprotectionprovidedagainstthe
intrusionofsolidobjects(suchasbodypartslikehandsandngers,
dust,accidentalcontact),anduids.
Therstnumeral(x)representsthedegreeofprotectionagainstthe
ingressofsolidobjects.
Thesecondnumeral(y)representsthedegreeofprotectionagainstthe
ingressofliquids.
ForproductswithanIPxyrating,refertotheClassicationofMedical
Deviceinthischapterforadescriptionofthatrating.Notallproducts
haveanIPxyrating.

CAUTION:

SAFETYGROUNDPRECAUTION
Pullingonthecablecancausethecordtodeteriorateresultingin
electricalproblems.

Removethepowercordfromthemainssourcebygraspingthe
plug.DONOTpullonthecable.

CAUTION:

CONSULTACCOMPANYINGDOCUMENTS
Theremaybespecicwarningsorprecautionsassociatedwiththe
devicethatarenototherwisefoundonthelabel.

Consulttheaccompanyingdocumentationformoreinformation
aboutsafelyusingthisdevice.

CAUTION:

ELECTRICSHOCK
Indicatesthepresenceofhazardousenergycircuitsorelectric
shockhazards.

Toreducetheriskofelectricshockhazards,donotopenthis
enclosure.Referservicingtoqualiedpersonnel.

CAUTION:

HOTSURFACE
Indicatesthatthemarkeditemmaybehot.

Takeappropriateprecautionsbeforetouchingtheitem.

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OptimaEMS

2061274-003B

SymbolDescriptions(cont'd.)

Introduction

Symbol

Description

Non-ionizingElectromagneticRadiation

Indicatesthattheequipmentemitselevated,potentiallyhazardous,
levelsofnon-ionizingradiation(electromagneticenergy)fordiagnosisor
treatment.

ProtectiveEarth(ground)
Identiestheterminalofaprotectiveearth(ground)electrodeorany
terminalthatisintendedforconnectiontoanexternalconductorfor
protectionagainstelectricshockincaseofafault.

FollowInstructionsForUse

Readandunderstandtheoperator'smanualbeforeusingthedevice
orproduct.

Asamandatoryactionsign,thissymbolisidentiedbyabluebackground
andwhitesymbol.

WARNING:

ENVIRONMENTALORHEALTHHAZARD
Incineratingthedeviceorproductcouldpresentarisktothe
environmentorhumanhealth.

Donotincineratethisdeviceorproduct.

Asageneralprohibitionsign,thissymbolisidentiedbyawhite
background,redcircularbandandslash,andablacksymbol.

WARNING:

HANDCRUSHINGHAZARD
Thisdevicecontainsmovingpartsthatcouldcrushtheuser'shand.

Keephandsclearofthedevicewhileitisinoperation.Disconnect
powerbeforereachingintoorservicingthedevice.

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.

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OptimaEMS

19

Introduction

SymbolDescriptions(cont'd.)

Symbol

Description

WARNING:

BODILYINJURY
Indicatesthepresenceofmechanicalpartsthatcanresultin
pinching,crushing,orotherbodilyinjury.

Toavoidriskofbodilyinjury,keepawayfrommovingparts.
Disconnectpowerbeforereachingintoareaorservicing.

Asawarningsign,thissymbolisidentiedbyayellowbackground,black
triangularband,andablacksymbol.

WARNING:

BODILYINJURY
Indicatesthepresenceofasharpedgeorobjectthatcancause
cutsorotherbodilyinjury.

Topreventcutsorotherbodilyinjury,donotcontactsharpedgeof
object.

Asawarningsign,thissymbolisidentiedbyayellowbackground,black
triangularband,andablacksymbol.

WARNING:

BODILYINJURY
Indicatesthepresenceofapotentialtip-overhazardthatcanresult
inbodilyinjury.

Toavoidriskofbodilyinjury,followallinstructionsformaintaining
thestabilityoftheequipmentduringtransport,installation,and
maintenance.

Asawarningsign,thissymbolisidentiedbyayellowbackground,black
triangularband,andablacksymbol.

UpperTemperatureLimit

Indicatesthemaximumtemperaturefortransportationandhandlingof
thispackage.Thelimitisindicatednexttotheupperhorizontalline.

TemperatureLimits

Indicatestheupperandlowertemperaturelimitsforthetransportation
andhandlingofthispackage.Theyareindicatednexttotheupperand
lowerhorizontallines.

CanBeRecycled

Indicatesyoumayrecyclethismaterialordevice.Recycleordisposeof
inaccordancewithlocal,state,orcountrylaws.

WasteElectricalandElectronicEquipment(WEEE)

Indicatesthisequipmentcontainselectricalorelectroniccomponents
thatmustnotbedisposedofasunsortedmunicipalwastebutcollected
separately.Contactanauthorizedrepresentativeofthemanufacturer
forinformationconcerningthedecommissioningofyourequipment.

20

OptimaEMS

2061274-003B

SymbolDescriptions(cont'd.)

Introduction

Symbol

Description

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)indicatestheproductiswithinthetolerances
ofhazardouschemicals.
TheContentMark(withtheRandlettersbelow)indicateswhich
hazardoussubstance(s)wasusedduringthemanufacturingofthe
electricalorelectronicequipmentthatexceedsmaximumtolerances.

Fragile

Indicatesthecontentsarefragile.Handlewithcare.

ThisWayUp

Indicatesthecorrectuprightpositionofthepackage.

DoNotStack

Indicatesthatyoushouldnotstackthecontainerorplacealoadon
thecontainer.

KeepDry

Indicatesthatyouneedtokeepthecontainerawayfromrainandother
sourcesofmoisture.

HumidityLimits

Indicatesupperandlowerhumiditylimitsforthetransportationand
handlingofthispackage.Theyareindicatednexttotheupperand
lowerhorizontallines.

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21

Introduction

SymbolDescriptions(cont'd.)

Symbol

Description

AtmosphericLimits

Indicatestheupperandlowerbarometricpressurelimitationsforthe
transportationandhandlingofthispackage.Theyareindicatednextto
theupperandlowerhorizontallines.

RxOnly

USFederallawrestrictsthisdevicetosalebyorontheorderofa
physician.

Thefollowingtabledescribescerticationsymbolsthatmaybeusedonyourdevice
oritspackaging.Theinclusionofasymbolinthistabledoesnotindicatethatyour
productwascertiedbythatsymbolsgoverningbodyandislistedforreferenceonly.
Toidentifywhichorganizationshavecertiedyourdevice,refertothelabelingonyour
deviceoritspackaging.

CerticationSymbols

Certication
Symbol

Description

ULMark

IndicatescompliancewithapplicableUnderwritersLaboratories
requirements.

ULListedMark

Indicatescompliancewithinternationalorregionalstandardsfor
UnderwritersLaboratoriessafetyrequirements.

ULListed,Canada/US

Indicatescompliancewithinternationalorregionalstandardsfor
UnderwritersLaboratoriessafetyrequirementsinCanadaandthe
UnitedStates.

ULClassicationMark

IndicatesthismedicalequipmentisULClassiedwithrespecttoelectric
shock,re,andmechanicalhazardsonlyinaccordancewithUL60601-1,
CAN/CSAC22.2NO.601.1,andIEC60601-2-25.

ULClassicationMark,Canada/US

IndicatesthismedicalequipmentisULClassiedwithrespecttoelectric
shock,re,andmechanicalhazardsonlyinaccordancewithUL60601-1,
CAN/CSAC22.2NO.601.1,andIEC60601-2-25fortheUSandCanada.

CEMark

IndicatesthedeviceorproductconformswithapplicableEU(European
Union)directives.

PCT(GOST-R)Mark

IndicatesthedeviceorproductconformswithapplicableRussian
Gosstandardtechnicalandsafetystandards.

22

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2061274-003B

CerticationSymbols(cont'd.)

Introduction

Certication
Symbol

Description

NRTLCertication

IndicatesthedeviceorproducthasmettheNationalRecognizedTesting
Laboratoriescertication.
TheNRTLcerticationattaintedisaddedtothemarkoftheapplicable
testinglaboratory.TheexampledisplaystheNRTLcerticationwith
theMETLaboratoriesmark.

ChinaMetrologyCertication

IndicatesthedeviceorproductcomplieswithapplicableChina
MetrologyCerticationrequirements.

FCCApproval(USonly)
IndicatesthedeviceorproductcomplieswithFederalCommunications
CommissionRulePart18SubpartB(Section18.203)–General
informationregardingapplicationsandauthorizationsforindustrial,
scientic,andmedical(ISM)equipment.

TÜVRheinland

Indicatesthedeviceorproductcomplieswithapplicabletechnical
andsafetyrequirementsfollowingtestingbyTechnischer
Überwachungs-Verein,(TechnicalInspectionsOrganization).

CCC(China)

IndicatesthedeviceorproductconformswithapplicableChina
requirements.

Training

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

Toseeavailabletraining,gototheGEHealthcaretrainingWebsite
(http://www.gehealthcare.com/usen/education/index.html).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.

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23

Introduction

ProductLabel

Theproductlabelislaidoutinthefollowingformat.Dependingontheproduct,the
labelmayvaryslightlyinformat,butitcontainsthesameinformation.

SerialNumberFormat

24

Item

1

2
3
4
5

Description

Productdescription

Manufacturernameandaddress
Productpartnumber
Productserialnumber
Productbarcode

Eachdevicehasaserialnumberthatuniquelyidentiesitandprovidesimportant
information.Youneedtheproductcodeandtheentireserialnumberbeforeservicing

OptimaEMS

2061274-003B

orrequestingsupportforyourproduct.Theserialnumberformatisshowninthe
followingillustration:

SerialNumberFormat

Introduction

ItemName

1

2

3

4

5

6

Description

ProductCodeThree-lettercodethatuniquelyidentiestheproductline.

See“ProductCodes”onpage25formoreinformation.

YearManufacturedTwo-digitcodeidentifyingtheyearthedevicewas

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

FiscalWeek
Manufactured

ProductSequenceFour-digitnumberidentifyingtheorderinwhichthis

ManufacturingSiteOne-lettercodeidentifyingthesitewherethedevicewas

Miscellaneous
Characteristic

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

devicewasmanufactured.Valuesrangefrom000to

9999.

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

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

ProductCodes

2061274-003B

Theproductcodeidentiesspecicsystemplatforms.
Youcanidentifytheproductcodeusingtheserialnumberlistedontheproductlabel

locatedinoneofthefollowingplaces:

•Ontheproductlabelattachedtothedevice.

•OntheproductlabelprovidedwiththeapplicationCD.

Forsoftwareapplicationsystems,youcanviewtheserialnumberbylaunchingthe
systemapplicationandclickingHelp>About.

Forinformationonlaunchingtheapplication,refertotheserviceoroperator'smanual
forthissystem.

OptimaEMS

25

Introduction

ServiceInformation

Thissectionprovidesinformationpertainingtothemaintenanceandservicingofthe
system.FamiliarizeyourselfwiththisinformationbeforerequestingservicefromGE
Healthcareoritsauthorizedrepresentatives.

ServiceRequirements

Failureonthepartoftheresponsibleindividual,hospital,orinstitutionusingthis
equipmenttoimplementasatisfactorymaintenanceschedulemaycauseundue
equipmentfailureandpossiblesafetyhazards.

Regularmaintenance,irrespectiveofusage,isessentialtoensurethatthecomponents
ofthissystemarealwaysfunctionalwhenrequired.

Customer-suppliedHardware

Customerswhopurchasetheirownequipmentareresponsibleforanyrepair
ormaintenance,andforcompletingequipmentcheckoutafteranyrepairor
maintenance.

SecurityUpdates

AlistofvirusesthatposeasignicantthreattoGEHealthcarecustomers'system
securityispostedontheGEHealthcareProductSecuritywebsite.

Asnewvulnerabilitiesandpotentialsecurityissuesarise,GEHealthcaremakesevery
efforttoquicklyidentifyandnotifycustomersofapprovedxes.Timeisrequired
forGEHealthcaretoidentifythevulnerability,testthex,andrunavalidationtest
onthesystemforsafetyandfunctionality.OnlyafterthisrigorousprocessdoesGE
Healthcarereleasetheofcialpatch.Whilewerecognizetheurgencytocorrectthese
problems,wemustensurethattheintegrityofthesystemisnotcompromised.

AftersecuritypatchesarevalidatedforspecicGEHealthcaresystems,the
informationisaddedtotheProductSecuritywebsite.Youcandownloadthepatch
directlyfromthewebsiteofthesoftwaremanufacturer(Microsoft,andsoforth)and
applyittoyourGEHealthcaresystem.Tocheckonthelatestinformationregarding
validatedsecuritypatches:

1.BrowsetotheGEHealthcareProductSecuritywebsite:http://

2.EnteryourSSOnumberandpasswordandclickLogIn.

3.UsethefeaturesontheGEHealthcareProductSecurityDatabaseWebsiteto

prodsecdb.gehealthcare.com

TheSingleSignOn(SSO)windowopens.

IfyoudonothaveanSSOnumber ,clicktheSignUplinktoobtainone.

identifysecuritypatchesthatyoucanapplytoyoursystem.

AdditionalAssistance

GEHealthcaremaintainsatrainedstaffofapplicationandtechnicalexpertstoanswer
questionsandrespondtoissuesandproblemsthatmayariseduringtheinstallation,
maintenance,anduseofthissystem.

26

OptimaEMS

2061274-003B

Introduction

ContactyourlocalGEHealthcarerepresentativetorequestadditionalassistance.

ManualInformation

Thissectionprovidesinformationforthecorrectuseofthismanual.
Keepthismanualwiththeequipmentatalltimesandperiodicallyreviewit.You

shouldrequesttrainingassistancefromGEHealthcare,ifneeded.

IntendedAudience

Thismanualisintendedforanoperatorofthesystem.Theoperatorrequirestraining
tobecomefamiliarwiththecapabilitiesandoperationsofthesystem.

•Readandunderstandallinstructionsinthemanualbeforeattemptingtousethe
product.

•RequesttrainingfromGEMedicalSystemInformationTechnologies,Inc.(GE
Healthcare)ifneeded.

AdditionalmanualsmaybeorderedbycontactingGEHealthcare.

ManualPurpose

DocumentConventions

TypographicalConventions

Thismanualcontainstheinstructionsnecessarytooperatethesystemsafelyandin
accordancewithitsfunctionandintendeduse.

Thismanualusesthefollowingconventions.

ConventionDescription
BoldTextIndicateskeysonthekeyboard,texttoenter,orhardwareitemssuchas

buttonsorswitchesontheequipment.

Italicized-Bold

Text

CTRL+ESC

<space>

Indicatessoftwaretermsthatidentifymenuitems,buttonsoroptionsin
variouswindows.

Indicatesakeyboardoperation.Aplus(+)signbetweenthenamesoftwo
keysindicatesthatwhileholdingtherstkey,youshouldpressandrelease
thesecondkey.Forexample,PressCTRL+ESCmeanstopressandholdthe
CTRLkeyandthenpressandreleasetheESCkey.

Indicatesthatyoumustpressthespacebar.Wheninstructionsaregiven
fortypingaprecisetextstringwithoneormorespaces,thepointwhere
youmustpressthespacebarisindicatedas<space>.Thisensuresthat
thecorrectnumberofspacesisinsertedinthecorrectpositionswithin
theliteraltextstring.Thepurposeofthe<>bracketsistodistinguishthe
commandfromtheliteraltextwithinthestring.

2061274-003B

OptimaEMS

27

Introduction

ConventionDescription
Enter

>

IndicatesthatyoumustpresstheEnterorReturnkeyonthekeyboard.Do
nottypeEnter.

Thegreaterthansymbol,orrightanglebracket,isaconcisemethodto
indicateasequenceofmenuselections.

Forexample,thestatement“Fromthemainmenu,selectSystem>Setup>
OptionstoopentheOptionActivationwindow”replacesthefollowing:

1.Fromthemainmenu,selectSystemtoopentheSystemmenu.

2.FromtheSystemmenu,selectSetuptoopentheSetupmenu.

3.FromtheSetupmenu,selectOptionstoopentheOptionActivation
window.

Illustrations

Allillustrationsinthemanualareprovidedasexamplesonly.Dependingonsystem
conguration,screensinthemanualmaydifferfromthescreensonyoursystem.

Allpatientnamesanddataarectitious.Anysimilaritytoactualpersonsis
coincidental.

Notes

RelatedDocuments

Notesprovideapplicationtipsoradditionalinformationthat,whileuseful,arenot
essentialtothecorrectoperationofthesystem.Theyarecalledoutfromthebody
textthroughaagwordandindentation,asfollows:

NOTE:

ThetiporadditionalinformationisindentedbelowtheNOTEagword.

Thefollowingdocumentsprovideadditionalinformationthatmaybehelpfulinthe
installation,conguration,maintenance,anduseofthissystem.

DocumentsRelatedtotheOptimaEMSServiceManual

PartNumberDocumentTitle

2061274–002

OptimaECGManagementSystemOperator’sManual

28

OptimaEMS

2061274-003B

ProductOverview

Thischapterprovidesageneraldescriptionoftheproduct,itsconnectivitytoother
devicesandinterfaces,andadescriptionofavailableoptions.

GeneralOperation

TheOptimaEMSSystemisasinglesoftwareproductthatisusedto:

•ManagetheregistrationandstorageofECGinformation,createanedition,and
auditthepatient'sexaminationreport.

•ConnectwiththeECGdevicethroughRS232oranetworkconnection,toreview
theECGdatafromtheECGdeviceanddisplayitinthePCmonitorforthedoctor's
diagnosis,andsupportthecomparisonwithhistoricalexaminationrecords.

•Implementtheinternalshareofmedicalinformationandimprovethedoctors'
workingefciency.

•Thissystemisavailableformultiple,concurrentendusersonasinglesystem.

2

DataAcquisition

TheusercanacquiredataintotheOptimaEMSdatabaseviadifferentinterfacesfrom
differentsources.Followingisasummaryofthedifferentinterfaces.

•CSI
OptimaEMScanacquiredatafromCartsviaaserialcableconnection,an

802.11b/gwirelessconnection,oraLANconnection.

NOTE:

CSIisaproprietaryprotocolrunningontopofSerialLineInternetProtocol(SLIP).

•DCP
OptimaEMScanacquiredatafromCartsviaan802.11b/gwirelessconnectionor
aLANconnection

NOTE:

DCPisaproprietaryprotocolrunningontopofHTTPprotocol.

•DirectMediaAcquisition
OptimaEMScanacquiredatastoredinaremovablestoragebyaCart,suchasa
oppydisk(onolderCarts)oraSecureDigital(SD)card.

•GeneralAcquisition

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OptimaEMS

29

ProductOverview

OptimaEMScanacquiredatafromeitheralocalfolderorasharedfolder.Thisis
theonlywaythatStressandHolterdatacanbeacquired.

•XMLImport
OptimaEMScanacquiredatafromthird-partydevicesthroughastandardXML
dataformat.Theusercanconvertthird-partydataintothisformatthrough
third-partydataconverters.

Newlyacquireddataislistedinthetasklist,whereausercanview,andeditthe
report.NewtasksareautomaticallyroutedtoacertainuseraccordingtotheTask
Assignmentconguration.ConrmedtasksareexportedtoEMSaccordingtoSystem
Conguration.ThefollowingDataTypestableliststhedifferentdatatypesthatcanbe
storedinOptimaEMS,alongwiththeacquisitiondeviceandtypicalrecordsize.

DataTypes

DeviceInterfaces

MACCarts

DataType

RestingECG—12Lead(500Hz)Electrocardiograph
Stress
Stress

Holter

AcquisitionDevice

CASE12/15/16
CASE8000/CASE
MARS1MB—2.5MB

TypicalRecordSize

10KB—20KB
50KB—400KB
750KB—3MB

TheOptimaEMSsystemcaninterfacewiththefollowingsystemsanddevices:

•MACCarts

•MARS

•CASE/CardioSoftStressSystems

•Compatiblethird-partyConverters

ECGdataacquiredattheMACcartscanbesenttotheOptimaEMSsystemfor
long-termstorage.Dependingonthetypeofcartandtheoptionsinstalled,youcan
senddataoneofseveralways:

•Removethedisketteorsecuredigital(SD)cardfromthecartandimportitthrough
anOptimaEMSclient.

•CSIdirect(directserialconnection)

•CSInetwork(wireless/LAN)

•DCPnetwork

•Sharedfolder

Carts,whichsupportOrderDownload,canretrieveordersfromOptimaEMS.Youmust
purchaseOrderDownloadasacartoption.TheOptimaEMSsystemrunsathreadfor
OrderDownloadforeachsite.CartsmustindicatethesiteID,fromwhichtheorders
aredownloaded.IfthesiteIDdoesnotmatchwiththethread,noorderisreturned.

ThefollowingtableprovidesthemethodsavailablefortransferringdatafromtheCart
totheOptimaEMSsystem.Manyofthemethodslistedinthefollowingtablerequire

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ProductOverview

thepurchaseandactivationofanoptionontheCart.RefertoyourGEHealthcare
salesrepresentativeformoreinformation.

ECGCartInterfacestoOptima

ECGCart

MAC600
MAC800
MAC1200
MAC1600
MAC3500
MAC5000
MAC5500

1

ThisoptionisavailableontheMAC3500onlyoutsideofNorthAmerica.

CSINetwork
Wireless

�����

��

����

�����

LAN

���

1

CSIDirect

��

�

��

DisketteSDCard

Order
Download

MARS

YoucanconguretheMARSHoltersystemstostoresavedPDFreportstotheOptima
EMSsystemforlong-termstorage.FullDisclosureisnotsenttotheOptimaEMS
system.Toaccomplishthedatatransfer,theOptimaEMSsystemconnectstoashared
folderontheMARSsystemoverthenetworkandcopiesthelestotheOptimaEMS
serverforprocessing.TheOptimaEMSsystemrequirestheHolterDataTypeoption.
UNIX-basedMARSsystemsrequiretheEnterpriseNetworkCardoption.TheOptima
EMSsystemneedsfullaccesstotheMARSsharedfolder.

CASE/CardioSoftStressSystems

YoucanconguretheCASE/CardioSoftStresssystemstostoresavedPDFreportsto
theOptimaEMSsystemforlong-termstorage.CASE/CardioSoftsystemsrequirea
networkoptiontosenddatatotheOptimaEMSsystem.TheCASE/CardioSoftsystem
copiesthelestoasharedfolderontheOptimaEMSsystem,andthentheOptima
EMSsystempicksuptheleslocallyforprocessing.YoumustenabletheStressData
TypeoptionontheOptimaEMSsystem.

NOTE:

TheOptimaEMSsystemneedsfullaccesstotheCASEfolder.

HL7Interface

ThesystemsupportsHL7interfacestoacceptADTandOrdermessagesfromHospital
InformationSystem(HIS).YoumustenabletheappropriateHISoptions(ADT,Orders)
inthesystem.

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31

ProductOverview

HL7Inbound

UsethefollowingproceduretoenabletheappropriateHISoption(ADT,orders)in
theOptimaEMSsystem:

1.ClickSystemConguration>SiteConguration.

Usethefollowingtabletosetyourcongurations.

Setting

AllowHL7ADTChecked
AllowHL7OrderChecked

2.Intheleftpanel,clicktheHL7ServiceEntrytab.

•EachsiteshoulduseanHL7serviceentrysingleton.Thismeansthateach
sitehasitsownmappedserviceentry.

•Ensurethattheportisnotoccupiedbyotherprogramsorsoftware.The
portisdifferentforeachsite.

3.Intherightpanel,clickStarttostarttheServiceEntry.

4.ConrmthattheServiceEntrystatusisRunning.
Youcanchangethecongurationoftheserviceentry(suchastheport,remove

serviceentry,andsoforth).

5.RestarttheServiceEntryserviceafterchangingitsconguration.
Afterthecongurationsarecomplete,theOptimaEMSsystemacceptsHL7

ADTandOrdermessagesfromHIS.

Value

HIS/EMROutbound

TheOptimaEMSsystemsupportsexportbillingandtestreportinformationtoashared
folderforHISortheEMRsystem.TheHL7outboundmessagedoesnotcommunicate
betweentheOptimaEMSsystemandHIS/EMRinreal-time.Afteryouenablethe
appropriateHISoption(HISoutput)intheOptimaEMSsystem,itexportsbillingand
testreportsautomaticallywhenthetestisconrmed.

ConnectHIS/EMRtothesharedfolderontheOptimaEMSsystemoverthenetwork.
UsethefollowingproceduretoengagetheOptimaEMSsystemforHISoutbound:

1.SelectSystemconguration>SiteConguration.
Congurethesettingsasdescribedinthefollowingtable:

Setting

AllowHISOutboundChecked

HISName

32

OptimaEMS

Value

Notempty

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ReportTemplateDefault

ProductOverview

Thistemplateisthetestreportformatto
exporttoHIS.

SharedFolder

AfteryouarenishedconguringtheHISOutboundsettings,theOptimaEMSsystem
exportsthebillingandtestreporttothesharedfolderautomaticallywhenauser
conrmsthetest.

OptionalFeatures

Toviewalistofinstalledoptionsonthesystem,clickHelp>Options...toviewthe
OptionsListscreen.

SetthistobeaccessedbytheHIS/EMR
system.

ThesharedfolderisontheOptimaEMS
server.Thedefaultpathis:

“C:\ProgramFiles\GEHealthCare\
OptimaEMSService\ECGData\MACIT
outBound"+HISName

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33

ProductOverview

ThefollowingtablelistsavailableoptionsfortheOptimaEMSsystem.

SystemFeaturesOptions

PurchasedOption

AdvancedECGReportDesignerProvidesECGreporttemplateforECGreport

UserManagement

ECGStatisticsandReportModuleIncludes:

ECG12SLMeasurementsMatrixModuleProvidesECG12SLmeasurementdatavalue.
StressModuleProvidestheabilitytoacquireStressdata

HolterModuleProvidestheabilitytoacquireHolterdata

HISHL7Communication

WebserviceHISIntegrationProvidestheabilitytoobtaininformation

Bi-directionalCommutationwithGEECG
Carts

Description

print.
Includes:

•rolemanagement

•usermanagement

•Statisticsreporttemplatefordatabase
query.

•Statisticsreportview,export,andprint.

fromGEHealthcaredevicesfordiagnosis.

fromGEHealthcaredevicesfordiagnosis.
Providestheabilitytoobtaininformation

fromHISthroughHL7.

fromHISthroughnonHL7.
Providesonlineorderdownloadfortesting.

AdvancedMeasurementToolModuleProvidesECGwaveformmeasurementtool

fordiagnosis.

12SLStatementLibraryModuleProvides:

•Marquette12SLAnalysisProgram
statementsfordiagnosis.

•User-dened12SLstatementsfor
diagnosis.

Specications

ThissectionprovidesthehardwareandsoftwarespecicationsfortheOptimaEMS
system.

HardwareSpecications

TheOptimaEMSsystemhasthefollowinghardwarespecications.

OptimaEMSSystemServer

HardwareSpecications

Processor

Xeonprocessor2-core2.8GHz

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OptimaEMSSystemServer(cont'd.)

ProductOverview

RAM
HarddiskFour500GBharddisk
NetworkingGigabitEthernet
Minimumdiskspaceforinstallation

4GBRAM,

1GB

OptimaEMSSystemClientWorkstation

HardwareSpecications

Processor
Memory
Harddrive
Minimumdiskspaceforinstallation
NetworkingFastEthernet

IntelPentium42.4GHzprocessor
1GB
80GB
1GB

OptimaEMSSystemAcquisitionWorkstation

HardwareSpecications

Processor
Memory
Harddrive
Minimumdiskspaceforinstallation

IntelPentium42.4GHzprocessor
1GB
80GB
1GB

NetworkingFastEthernet

SoftwareSpecications

TheOptimaEMSsystemhasthefollowingsoftwarespecications.

Server

System

OperatingSystem

DatabaseMicrosoftSQLServer2008R2

Client

System

ClientWorkstationMicrosoftWindowsXPProfessional
AcquisitionWorkstationMicrosoftWindowsXPProfessional

Software

MicrosoftWindows2003Serverorlater
version.

Software

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OptimaEMS

35

ProductOverview

OptimaEMSDriveContentsandSupporting Folders

BydefaultOptimaEMSserver/clientisinstalledontheCdrive.Theusercanchange
thedriveduringinstallation.

TheusercaninstalltheOptimaEMSserver,client,anddatabaseononePC,or
separatePCs.

OntheOptimaEMSserver,theinstallationprogramcreatesasharedfolderfordata
acquisitioncalledOptimaEMSECGdata.OntheOptimaEMSclient,ifitactsasadata
acquisitionhost,itrequiresasharedfoldercalledOptimaEMSECGdataclient.

OptimaEMSServices

TheOptimaEMSserverrunsasaWindowsservicenamedOptimaEMSService.Its
startuptypeissetasautomaticsotheservicestartsautomaticallyaftertheserver
isstarted.

RequiredNetworkPorts

ThefollowingportinformationisprovidedfortheOptimaEMSsystemasaguidelineto
helpyouunderstandthesystem’snetworkingrequirementsandtoassistinsituations
whereyoumayneedtoconsidereithersoftwareorhardwarerewallcongurations.
Notallsystemsuseeachconnection.Thefollowingportsaredefaultvaluesand,in
somecases,canbechanged.

TherearethreetypesofTCPportsintheOptimaEMSsystem.Allofthemare
congurable.

•OptimaEMSServerhostsaWCFservice.Bydefaulttheportis8999.Theusercan
congureitintheleOptimaEMSService.exe.cong.

•IfadevicetransmitsthedataviaDCP,youshouldconguretheDCPserverand
portinDeviceconguration.

•TheHL7inboundservicecommunicatesonanotherport.Congurethisportin
HL7ServiceEntryconguration.

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SystemAdministration

RemoteDatabases

SQLPorts

3

Thischapterprovidesproceduresforadministrativefunctionsyoumayneedtodoon
theOptimaEMSsystem.

Thissectionprovidesadditionalconsiderationstoensuresysteminstallationand
operationonaremotedatabase.RemotedatabasemeansthattheSQLinstance
runningthesystemdatabasesislocatedonaseparateserver.Inasimplesystem
conguration,thesystemapplication,theSQL,andsystemdatabasesareallinstalled
onthesameserver.

IftheOptimaEMSsystemisusingaremoteOptimaEMSdatabase,theOptimaEMS
serverrequiresaccesstotheOptimaEMSdatabases.Thisrequiresthefollowing
portsbeopentotheSQLserver.

•SQLListeningPort
Thelisteningportlistensforincomingconnections.IntheOptimaEMSsystem,
theseincomingconnectionsoriginateattheOptimaEMSserver.SQLassignsTCP
port1433asthelisteningportwhenthedefaultinstanceofSQLisused.Ifthe
customerwantsaddedsecurity,theycanchangethisport.Whenusinganamed
instanceofSQL,SQLassignsadynamicport,whichthedatabaseadministrator
(DBA)canchangetoaknownxedport.

•SQLMonitorServer
ThemonitorserverserviceusesUDPport1434,whichallowsadministratorsand
userstocheckthestatusoftheSQLdatabases.Likethelisteningportdescribed
previously,thecustomercanassignthisportadifferentportnumberforincreased
security.

IftheOptimaEMSserverishavingproblemscommunicatingwiththedatabase,and
theOptimaEMSserviceaccountshaveSuperAdminprivileges,contactthelocalDBA
andverifythatthecorrectportsareopen.

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OptimaEMS

37

SystemAdministration

SQLRemoteConnections

Wheninstalledonaseparatedatabase,theOptimaEMSsystemrequiresthattheSQL
remoteconnectionsareenabledasfollows.ContactthelocalITdepartmentorDBA
foradditionalassistancefortheSQLRemoteconnections.

1.OntheSQLserver,gotoStart>MicrosoftSQLServer2005>Conguration

Tools>SQLServerSurfaceAreaConguration.

2.ClickSurfaceAreaCongurationforServicesandConnections.

3.UndertheSQLinstancewheretheOptimaEMSdatabasesarebeinginstalled,

selectRemoteConnections.

4.VerifythattheLocalandremoteconnections>UsingbothTCP/IPandName

Pipescheckboxisselected.
Ifitisnotselected,selectthecheckboxandapplythechange.

5.ExittheSQLServer2005SurfaceAreaCongurator.

NOTE:

InadditiontotheRemoteConnectionsconguration,youmuststarttheSQL
ServerBrowserservice.

Installing/Uninstalling/Upgrade

Thissectiondescribestheprocessforinstalling,uninstalling,andupgradingthe
OptimaEMSsystem.

InstallingtheOptimaEMSSystem

ListedbelowarethebasicstepsrequiredtoinstallanewOptimaEMSsystemserver
andclient.

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InstallingtheSystemServer

GEHCsupportteamwillhelpyoutoinstallthesystemserver.

NOTE:

Whenprocessingtheinstallation,youcanclickBackatanytimeifyouwantto
modifyyourpreviousentries.YoucanclickCancelwhenyouwanttoabortthe
installation.

1.InserttheinstallationCDintothecomputer.

2.OpenMyComputer.

Thefollowingwindowopens:

SystemAdministration

3.OpenOptimaEMS>OptimaEMSV1.0>OptimaEMS>OptimaEMSServiceto

opentheInstallationLanguageSelectionwindow.
Thesystemdefaultstosettheinstallationlanguageastheoperatingsystem’s

language.Youcanusethedrop-downmenutoselectChineseorEnglishif
needed.

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39

SystemAdministration

4.ClickYestoopentheWelcomewindowandclickNexttocontinue.

TheLicenseAgreementwindowopens.

5.Dooneofthefollowingactions:

•Ifyouchoose“Iacceptthetermsofthelicenseagreement”,youcanclickNext
tocontinuewiththeinstallation.TheCustomerInformationWindowopens.

•Ifyouchoose“Idonotacceptthetermsofthelicenseagreement”,theNext
buttonisdisabledandyoucanclickCanceltoexittheinstallation.

•Ifyouwanttoprintoutthetermsofthelicenseagreement,clickPrint.

40

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6.OntheCustomerInformationwindow:

SystemAdministration

a.EnteryourUserNameandCompanyName.
b.Choosetherangeofusers.

Installthisapplicationfor:

•Anyonewhousesthiscomputer(allusers).

•Onlyforme(GE)

7.ClickNexttocontinuetheinstallation,andopentheDatabaseServerSettings
window.

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41

SystemAdministration

8.EntertheServerName,LoginIDandPassword.

9.ClickNexttoopentheSiteInformationwindow.

10.EnteryourSiteName,yourcomputerIPAddress,andSerialNumber.

11.ClickNexttogototheChooseDestinationLocationwindow.

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SystemAdministration

12.ClickBrowsetochoosethelocationwhereyouwanttoinstalltheOptimaEMS
SystemServeronyourcurrentcomputer.

13.ClickNexttoopentheReadytoInstalltheProgramwindow,andclickInstallto
starttheinstallation.

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43

SystemAdministration

Waituntiltheprogressbarisnished.Thenthesystemautomaticallyopensthe
InstallShieldWizardCompletewindow.

14.ClickFinishtocompleteOptimaEMSSystemServerinstallation.

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InstallingtheSystemClient

GEHealthcaresupportteamwillhelpyoutoinstallthesystemClient.

NOTE:

1.InserttheinstallationCDintothecomputer.

2.OpenMyComputer.

SystemAdministration

Whenprocessingtheinstallation,youcanclickBackatanytimeifyouwantto
modifyyourpreviousentries.YoucanclickCancelwhenyouwanttoabortthe
installation.

Thefollowingwindowopens:

3.OpenOptimaEMS>OptimaEMSV1.0>OptimaEMS>OptimaEMSClientto
openInstallationLanguageSelectionwindow.

Thesystemdefaultstosettheinstallationlanguageastheoperatingsystem’s
language.Youcanusethedrop-downmenutoselectChineseorEnglishif
needed.

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OptimaEMS

45

SystemAdministration

4.ClickYestoopentheWelcomewindowandclickNexttocontinue.
TheLicenseAgreementwindowopens.

5.Dooneofthefollowingactions:

•Ifyouchoose“Iacceptthetermsofthelicenseagreement”,youcanclickNext

tocontinuewiththeinstallation.TheCustomerInformationWindowopens.

•Ifyouchoose“Idonotacceptthetermsofthelicenseagreement”,theNext

buttonisdisabledandyoucanclickCanceltoexittheinstallation.

•Ifyouwanttoprintoutthetermsofthelicenseagreement,clickPrint.

6.OntheCustomerInformationwindow,enteryourUserNameandCompany
Name.

7.Choosetherangeofusers.
Installthisapplicationfor:

•Anyonewhousesthiscomputer(allusers).

•Onlyforme(GE)

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OptimaEMS

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SystemAdministration

8.ClickNexttoopentheServerCongurationwindow.
UsethefollowingtabletocompletetheServerCongurationwindow.

IPaddress

PortNumber

Test

These2eldshavedefaultvalues,you
donotneedtochangethemnormally
becausetheOptimaEMSSystemClient
Installationprogramcanautomatically
gettheIPaddressandportnumberof
theServer.

Thisisaconnectiontestbutton,which
canverifythecorrectnessofIPaddress
andportnumber .WithcorrectIPaddress
andportnumber,thetestwillshow
ConnecttotheServerSuccessfully.

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OptimaEMS

47

SystemAdministration

9.ClickNexttoopentheReadytoInstalltheProgramwindow,andclickInstallto
starttheinstallation.

48

OptimaEMS

2061274-003B

Waituntiltheprogressbarisnished.Thenthesystemautomaticallyopensthe
InstallShieldWizardCompletewindow.

10.ClickFinishtocompletetheOptimaEMSSystemClientinstallation.

SystemAdministration

InstalltheClickOnceOptimaEMSApplication

TheOptimaEMSsystemclientandserverisinstalledonthesameserver.The
OptimaEMSsystemclientisonlyOptimaapplicationpublishprogram.Theenduser
(physicians)caninstallOptimaEMSapplicationthroughwebbrowser.

1.OpenInternetExplorer.

NOTE:

InternetExplorerVersion8isrecommended.

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49

SystemAdministration

2.TypetheOptimaEMSApplicationPublishaddress:http://“yourserverIP

address”/OptimaEMS/publish.htmintheAddressbarofInternetExplorer.

ThePublishpageopens.

50

OptimaEMS

2061274-003B

3.ClickDownloadtodownloadandthePrerequisitesdisplayedonthePublish
page.

Thefollowingprerequisitesarerequired:

•Microsoft.NETFramework4(×86and×64)

•VisualC++2010RuntimeLibraries(×86)

•VisualC++2005RuntimeLibraries(×86)

4.Ifallprerequisitesareinstalled,clickInstall.

5.TheSecurityWarningwindowopens.

SystemAdministration

6.ClickInstalltostartrunningtheinstallation,andtheInstallingOptimaEMS
windowopens.

7.Whentheinstallationisnished,ashortcuticonisdisplayedonthedesktop.

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51

SystemAdministration

UninstallingtheOptimaEMSSystem

ThissectiondescribeshowtouninstalltheOptimaEMSSystemServerandClient.

UninstalltheOptimaEMSSystemServer

UsethefollowingproceduretouninstalltheOptimaEMSSystemServer.

1.OpentheAddorRemoveProgramswindowbyclickingStart>ControlPanel
>AddorRemovePrograms.

2.SelectOptimaEMSServiceandclickRemove.
TheUninstallConrmationwindowopens

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OptimaEMS

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SystemAdministration

3.ClickYestoconrmthatyouwanttouninstallOptimaEMSService.

4.WaituntiltheUninstallCompletewindowopens.
ClickFinishtocompletetheServeruninstallation.

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53

SystemAdministration

UninstalltheOptimaEMSSystemClient

UsethefollowingproceduretouninstalltheOptimaEMSSystemClient.

1.OpentheAddorRemoveProgramswindowbyclickingStart>ControlPanel
>AddorRemovePrograms.

2.SelectOptimaEMSClientandclickRemove.
TheUninstallConrmationwindowopens.

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OptimaEMS

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SystemAdministration

3.ClickYestoconrmthatyouwanttouninstallOptimaEMSClient.

4.WaituntiltheUninstallCompletewindowopens.
ClickFinishtocompletetheClientuninstallation.

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55

SystemAdministration

UninstalltheClickOnceOptimaEMSApplication

UsethefollowingproceduretouninstalltheClickOnceOptimaEMSApplication.

1.OpentheAddorRemoveProgramswindowbyclickingStart>ControlPanel
>AddorRemovePrograms.

2.SelectOptimaEMSandclickRemove.
TheOptimaEMSMaintenancewindowopens.

3.ClickOKtouninstalltheClickOnceOptimaEMSapplication.

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UpgradingtheOptimaEMSSystem

WhenanenduserrunstheOptimaEMSapplication,itdetectsifaversionisalready
installed.Ifanolderversionisinstalled,theOptimaEMSapplicationupdatesthe
systemtothenewversionautomatically.

SystemAdministration

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OptimaEMS

57

SystemAdministration

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Maintenance

MaintenanceGuidelines

4

Aregularequipmentmaintenanceprogramhelpspreventunnecessaryequipment
andpowerfailuresandalsoreducespossiblehealthhazards.Thischaptercontains
instructionsforthefollowingrecommendedmaintenance:

•Cleaningtheequipment'saccessories

•Visualinspectionofequipment

•Exteriorcleaningofequipment

•Conductingrepairandreplacementcheckoutprocedures.

GEHealthcarerecommendsthatyouperformthetestsdescribedinthischapter:

•Everyyearaspartofroutinemaintenance.

•Wheneverinternalassembliesareserviced.

•Wheneveryourepairorreplaceequipment.

•AsprescribedintheOEMdocumentationthatcomeswiththeequipment.

OEMMaintenance

2061274-003B

NOTE:

UnlessyouhaveanEquipmentMaintenanceContract,GEHealthcaredoesnot
assumeresponsibilityforperformingtherecommendedmaintenanceprocedures.
Thesoleresponsibilityrestswiththeindividualorinstitutionusingtheequipment.
GEHealthcareservicepersonnelmay,attheirdiscretion,followanyorallofthe
proceduresasaguideduringvisitstotheequipmentsite.

Itemsrequiringmaintenanceinclude:

•OptimaEMSserver(s)

•OptimaEMSClient

•Monitors

•DVD-RWorCD-RWDrive

•Printer

ForinformationonmaintenanceofOriginalEquipmentManufacturer(OEM)
components,pleasereferencetheappropriateOEMmanualsfortherecommended

OptimaEMS

59

Maintenance

maintenanceoftheirproduct.ForlinkstotheOEMmanuals,refertotheOptima
EMSSystemHardwareManual.

Fortechnicalsupport,contactyourlocalGEHealthcaretechnicalsupportteam.

FunctionalCheckoutProcedures

Wheneverasystemisserviced,youmustperformcheckoutprocedurestocomply
withFDAguidelinestoensurethatthesystemissafeandfunctioningproperly.The
specicproceduresdependontheserviceperformed.

Followthecheckoutprocedureappropriatefortherepairyouperformed.

NOTE:

Forcustomer-suppliedhardware,thecustomerisresponsiblefortroubleshooting,
FRUreplacement,andcheckouts,astheyrelatetohardwarerepairsonthe
systemservers.

Non-FRURepairs

Systemfunctionalchecksarerequiredfornon-FRUrepairsandtypicallyinvolve
systemsetupandcongurationsthatyoucanperformremotelyoronsite.Ifyou
performthemremotely,theremotesupportengineercanconrmthemthrough
remoteaccess,orverifythemwiththecustomercontact.Foradditionalinstructions,
refertotheOperator'smanualforyoursystem.

Printing

Usethefollowingprocedurestoverifythattheprintingfunctionsareworkingcorrectly.

PreviewPrintCheckout

1.Double-clickaconrmedorderontheorderlisttoopendiagnosiseditor.

2.Selectpreviewprintmodefromthedrop-downmenu.

3.ClickPrinttoopenpreviewprintdialog.

4.Selectprinterandreporttemplate,andclickOK.

5.VerifythattheECGrecordprintedoutthroughselectedprinterandreport
template.

DirectPrintCheckout

1.Double-clickaconrmedorderontheorderlisttoopendiagnosiseditor.

2.Selectdirectprintmodefromthedrop-downmenu.

3.ClickPrint.

4.VerifythattheECGrecordprintedoutthroughdefaultprinterandreport
template.

Editing/Conrming

Usethefollowingprocedurestoverifythattheeditingandconrmingfunctionsare
workingcorrectly.

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EditRecordCheckout

1.AcceptaprocessingorderinOrderList.

2.Double-clickanacceptedordertowaveformviewereditandsavetherecord.

3.Re-opentherecordtoverifythechangesweresaved.

ConrmRecordCheckout

1.AcceptsaprocessingorderinOrderList.

2.Double-clickacceptedordertowaveformviewereditandconrmtherecord.

3.Re-opentherecordtoverifythechangesweresaved.
VerifytherecordisconrmedinOrderList.

ReportDistributionCheckout

Usethefollowingprocedurestoverifythatthereportdistributionfunctionisworking
correctly.

1.CreateareporttemplateinReportDesignerwindow.

Maintenance

DeviceSetup

UserSetup

CartsTransmission/Acquisition

2.SettheprintmodeaspreviewprintinClientConguration.

3.Enterwaveformviewerbydouble-clickaconrmedorderinOrderList.

4.Printareportwiththeselectedreporttemplate.

Usethefollowingprocedurestoverifythatthedevicesaresetupcorrectly.

1.Transmitarecordfromasourcedevice.

2.Verifythattherecordisdisplayedintheapplication.

Usethefollowingprocedurestoverifythattheuserissetupcorrectly.

1.Haveanewlycreateduserstarttheapplication.

2.Havetheuserlogonandconrmapplicationaccessbasedonroles/privileges
givenduringsetup.

UsethefollowingprocedurestoverifythattheCartstransmissionsandacquisitions
functionsareworkingcorrectly.

WirelessTransmission

1.CongurethecommunicationmethodonaCart.

2.ConguretheECGdeviceintheOptimaEMSsystem,andmakesurethe
congureisthesameastheCart.

Asharedfolderisassociatedwiththedevice.

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61

Maintenance

3.FromtheCart,transmittheECGlethroughwireless.
TheOptimaEMSsystemdetectsandparsesthelesotheusercancomplete

ananalysis.

4.CheckthatthePID/NameoftheECGtransmittedfromthecartwasacquiredin
theOptimaEMSsystem.

LANTransmissionCheckout

1.CongurethecommunicationmethodonaCart.

2.ConguretheECGdeviceintheOptimaEMSsystem,andmakesurethe
congureisthesameastheCart.

Asharedfolderisassociatedwiththedevice.

3.FromtheCart,transmittheECGlethroughLAN.
TheOptimaEMSsystemdetectsandparsesthelesotheusercancomplete

ananalysis.

4.CheckthatthePID/NameoftheECGtransmittedfromthecartwasacquiredin
theOptimaEMSsystem.

RemovableMediaAcquisition

1.Insertthemediaintotheclient.

2.Downloadtheinitializedorderstothemedia.

3.InsertthemediatoCart,acquiretheECGrecordandsendittomediaonCart.

4.Insertthemediatotheclientagain,andselectthetestfrommediabackto
theOptimaEMSsystem.

TheOptimaEMSsystemdetectsandparsesthelesotheusercancomplete
ananalysis.

5.CheckthatthePID/NameoftheECGtransmittedfromthecartwasacquired
inOptimaEMSsystem.

MARSTransmission

UsethefollowingproceduretotransmitaHolterreporttotheOptimaEMSsystem.

1.ConguretheHolterdeviceintheOptimaEMSsystem.
Asharedfolderisassociatedwiththedevice.

2.FromaMARSworkstation,exporttheHolterreporttoaPDFle.

3.CopythePDFletothesharedfolderconguredinstep1.
TheOptimaEMSsystemdetectsandparsesthelesotheusercancomplete

ananalysis.

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CASE/CardioSoftTransmission

DatabaseSearch

Maintenance

UsethefollowingproceduretotransmitaStressreporttotheOptimaEMSsystem.

1.ConguretheStressdeviceintheOptimaEMSsystem.
Asharedfolderisassociatedwiththedevice.

2.FromaCASE/CardioSoftworkstation,exporttheStressreporttoaPDFle.

3.CopythePDFletothesharedfolderconguredinstep1.
TheOptimaEMSsystemdetectsandparsesthelesotheusercancomplete

ananalysis.

Usethefollowingprocedurestoverifythatthedatabasesearchfunctionisworking
correctly.

ManualSearchCheckout

1.GototheDatabaseSearchfunctionoftheapplication.

2.Createasearch.

3.Choosecriteriaandrunthesearch.

4.Verifythatthesearchresultsmatchtheselectedcriteria.

AutomaticSearchCheckout

1.GototheDatabaseSearchfunctionoftheapplication.

2.Createasearch.

3.Savethecriteria.

4.Schedulethesearch.

5.Verifythatthesearchrunswhenscheduledandexpectedresultsaregenerated.

RemoteSupport

Usethefollowingprocedurestoverifythattheyoucanaccessthesystemforremote
support.

1.Logontothecustomer'ssystemusingtheremoteconnectionconguredfor

2.Conrmthatyoucanaccessthecustomer'sdesktopviatheremoteconnection.

3.Conrmthatyoucanuploadanddownloadlestothecustomer'ssystem.

TheOptimaEMSsystemrunsallscheduledsearchesonlyonceperday.

thatsystem(InSiteExC).

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63

Maintenance

XMLImport

Backup

UsethefollowingprocedurestoverifythatthesystemcanimportXMLdatacorrectly.

1.Congurethenon-GEdeviceintheOptimaEMSsystem.
Asharedfolderisassociatedwiththedevice.

2.CopyXMLdatalesfromthemanufacturer’sdevicetothesharedfolder
conguredinStep1.

TheOptimaEMSsystemdetectsandparsesthelesotheusercancomplete
ananalysis.

3.CheckthatthePID/NameoftheECGtransmittedfromthecartwasacquired
inOptimaEMSsystem.

Usethefollowingprocedurestoverifythatthebackupproceduresworkcorrectly.

1.UseSQLServerManagementStudiotorunamanualOptimaEMSbackup.

2.Conrmthatthebackupwassuccessful.

Login

UsethefollowingprocedurestoverifythattheOptimaEMSAuthenticationprocedures
workcorrectly.

OptimaEMSAuthentication

1.HavetheuserlogontotheOptimaEMSsystemusingOptimaEMS
Authentication.

2.VerifytheuserisabletosuccessfullylogontotheOptimaEMSsystem.

ViaCitrixUsingOptimaEMSAuthentication

1.HavetheuserlogontotheOptimaEMSsystemusingOptimaEMS
Authentication.

2.VerifytheuserisabletosuccessfullylogontotheOptimaEMSsystem.

Discarding/Recovering/DeletingData

Usethefollowingprocedurestoverifythattheusercandiscardatest.

DiscardingData

1.Puta.docletodevicefolderontheOptimaEMSsystem.

2.VerifythatthediscardlogexistsinthelogleoftheOptimaEMSsystem.

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OptimaEMSSystemBackupand Recovery

Introduction

Abackupandrecoveryplaniscrucialtopreventdatalossandtominimizeservice
interruptionintheeventofsystemfailureordisaster.Thischapterdescribesthe
backupandrecoveryoptionsfortheOptimaEMSsystem.

BackupandRecoveryoftheDatabase

TherearetwowaystobackuptheOptimaEMSdatabase:manuallyorusingSQL
Servertools.

5

BackingUpandRecoveringtheDatabaseManually

Thefollowingproceduresdescribehowtobackupandrecoverthedatabasemanually.

1.StoptheSQLServer.
a.ClicktheStartbuttoninthebottomleftcorner.
b.IntheStartmenuselectRun….
c.Inthepopupwindowtextbox,enterservices.msc.
d.FindtheSQLServerserviceandclicktheStopServicebuttononthe

toolbar.

2.IntheSQLServerinstallationfolder,ndtheMacIt.mdfandMacIt_log.ldfles.
Bydefault,thefolderislocatedinC:\ProgramFiles|MicrosoftSQL

Server\MSSQL.1\MSSAL\DATA.

3.Copythetwolestoabackupfolder,forexampleD:\DbBackup.

4.IntheServiceswindow,clicktheStartServicebuttononthetoolbartorestart
theSQLServerservice.

5.Torestorethele(forexample,thedataleiscorrupted),stoptheSQLService.

6.CopytheMacIt.mdfandMacIt_log.ldflesbacktotheSQLServerinstallation
folder.

7.Restarttheservice.

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65

OptimaEMSSystemBackupandRecovery

BackingUpandRecoveringtheDatabaseUsingSQLServer Tools

Thefollowingproceduresdescribehowtobackupandrecoverthedatabaseusingthe
SQLServertools.

1.IntheSQLServer2005/2008ManagementStudio,clickDatabase.

2.Right-clickthemacitdatabase.

3.IntheContextmenu,selectTasks>Backup….

4.Inthepopupwindow,acceptthedefaultsettingsandclickAddtoselectthe
pathandnameforthebackuple.

5.ClickOKtocompletethebackupprocedure.

6.Torestorethedatabaselesright-clickthemacitdatabase.

7.IntheContextmenu,selectTasks>Restore>Database….

8.Inthepopupwindow,insourceandlocationselectfromdeviceandclickOK.

9.Inthenewpopupwindow,selectFileasthebackupmediaandclickAdd.

10.Selectthebackuplegeneratedinstep4.

11.ClickOKtorestorethedatabase

AdditionalInformation

Whenconguringorperformingthesystembackups,youmayneedtoshutdown
thesystem,restartthesystem,orinitializeanewbackuptape.Theinstructionsfor
performingtheseadditionaltasksareprovidedinthefollowingsections.

SystemShutdownandRestartProcedure

DuringtheOptimaEMSbackupandrecoveryprocess,itmaybecomenecessary
toshutdownandrestartthesystem.Thissectionprovidesinstructionsforsafely
shuttingdownandrestartingthesystem:

NOTICE:

DATALOSSORCORRUPTION:ShuttingdownorrestartingtheOptimaEMSsystemanyway
otherthanthatspeciedinthismanualcouldresultindatalossorcorruption.

FollowtheinstructionsprovidedinthismanualtoshutdownandrestarttheOptima
EMSsystem.

1.NotifyusersthatyouareabouttoshutdowntheOptimaEMSsystemsothey
cansavetheirchangesbeforethesystemisshutdown.

Thispreventsanychangesbeingmadetoopentestsfrombeinglostwhenthe
systemisshutdown.Recordsthatareopenwhentheuserisdisconnected
remainlockedbutcanbeunlockedbyauserwiththeproperpermissionsunder
Status>LockedDataList.

2.FromtheWindowsdesktopontheOptimaEMSserver,selectStart>ShutDown.

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OptimaEMS

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3.Selecteitherofthefollowingoptions:

•Restart

Thisoptionpowersdownandimmediatelyrestartsthecomputer.

•Shutdown

Thisoptionpowersdownthecomputeruntilyoumanuallyrestartit.

TheOptimaEMSserviceslaunchautomaticallywhentheserverrestartsandare
availableimmediatelytoOptimaEMSclients.IfthesystemhasanHL7interface,
theinboundmessagesqueueontheHL7serveruntiltheOptimaEMSserver
isrestarted.

4.AftertheFileserverisrestarted,verifythatalloftheOptimaEMS-relatedservices
havestartedandthatyoucanruntheOptimaEMSapplicationontheserver.

5.VerifythatclientsareabletoattachwhenrunningtheOptimaEMSapplication.

InitializingaNewTape

WhenusinganAITtapeforthersttime,youmustinitializeittoreceivedata.Usethe
followingproceduretoinitializeanewtape:

OptimaEMSSystemBackupandRecovery

1.Insertanewtapeintothetapedrive.

2.Right-clickonMyComputerandselectManage.

3.ExpandRemovableStorageandselectMedia.
Thetapeshouldbelistedontheright.Ifitisnew,itdisplaysintheMediaPool

columnas\Unrecognized\8mmAIT1.

4.Highlightthenewtapeinthelist.

5.Onthemenu,clickAction>Free.
Thefollowingmessageopens:

6.ClickYes.
Anothermessageopensaskingyoutoconrmthatyouwanttomakeitfree.

7.ClickYes.

8.Labelthetapeexternally.Foranightlytape,labelit<Day>Backup,whereDay
isreplacedbytheappropriatedayoftheweek.Fortheweeklytape,labelit
WeeklyC:Backup.Forthemonthlytape,labelitMonthlyBackup.

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67

OptimaEMSSystemBackupandRecovery

68

OptimaEMS

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ProductSpecication

ThissectionprovidesthehardwareandsoftwarespecicationsfortheOptimaEMS
system.

StorageEnvironmentalRequirements

TheOptimaEMSsystemhasthefollowingenvironmentalrequirements.

Label

A

StorageRequirement

Humidity
Temperature

DVD

StorageRequirement

Transport/StorageTemperature
Transport/StorageRelativeHumidity
Transport/StoragePressure

Specication

<65%

-30°Cto+60°C

Specication

-30ºCto+60ºC

10%to95%(non-condensing)
500hPato1060hPa

FunctionalLimitations

TheOptimaEMSsystemhasthefollowingfunctionallimitations.

Password

Field

Password16characters

SiteBasicInformation

Field

MaximumInput

MaximumInput

SiteNumber16characters

SiteName
ShortTitleoftheSite16characters

SiteDescription

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OptimaEMS

32characters

128characters

69

ProductSpecication

SiteBasicInformation(cont'd.)

Telephonenumber20characters

HostName

20characters

PortNumber

32integers

DepartmentBasicInformation

Field

DepartmentName

DepartmentDescription

MaximumInput

16characters
128characters

RoleBasicInformation

Field

RoleName32characters
RoleDescription64characters

MaximumInput

UserBasicInformation

Field

UserLoginName

UserName

Password16characters
ConrmPassword16characters

MaximumInput

16characters
16characters

UserDescription
OfcePhoneNumber20characters
E-mailAddress128characters
FaxNumber32characters
CellphoneNumber11characters

128characters

DiagnosisInformation

Field

Diagnosis

MaximumInput

512characters

PatientInformation

Field

PatientID

PatientName

Age

PhoneNumber32characters
Address128characters

MaximumInput

32characters
20characters
8characters

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ProductSpecication

HardwareSpecications

TheOptimaEMSsystemhasthefollowinghardwarespecications.

SystemServer

Hardware

Processor
RAM
HardDisk
EthernetGigabit
Diskspaceforinstallation

SystemClientWorkstation

Hardware

Processor
Memory
HardDisk
Ethernet
Diskspaceforinstallation

SystemAcquisitionWorkstation

Hardware

Processor
Memory
HardDisk
Ethernet
Diskspaceforinstallation

MinimumRequirements

Xeonprocessor2-core2.8GHz
4GB
500GB

1GB

MinimumRequirements

IntelPentium42.4GHz
1GB
80GB
Fast
1GB

MinimumRequirements

IntelPentium42.4GHz
1GB
80GB
Fast
1GB

SoftwareSpecications

TheOptimaEMSsystemhasthefollowingsoftwarespecications.

SystemServer

System

OperatingSystem

DatabaseMicrosoftSQLServer2008R2

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OptimaEMS

Software

MicrosoftWindows2003Serverorlater
version

71

ProductSpecication

Client

System

SystemClientWorkstation
SystemAcquisitionWorkstation

Software

MicrosoftWindowsXPProfessional
MicrosoftWindows7Professional,32–bit

OperationSystem

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OptimaEMS

2061274-003B

Index

A

assistance26

C

CommonDocumentation

Library(CDL)2

compliance14

ITE15

conventions

document27
illustrations28
Notes28
safety14
typographical27

customer-suppliedhardware26

D

device

symbols16

document

partnumber2

revision2
documentconventions27
documents

related28

I

identication

equipment23
illustrationconventions28
information

service26
InformationTechnology

Equipment(ITE)15

requirements15
IntendedAudience27
ITE15

L

label

equipment

manufacturer’s15

N

Notesconventions28

O

OEM2
OriginalEquipment

Manufacturer(OEM)2

E

equipment

identication23

equipmentmanufacturer’s

label15

G

GEHealthcare

CommonDocumentation

Library(CDL)2

manuals2

P

packaging

symbols16
partnumber

document2
patientvicinity

denition15

requirements15
product

codes25
ProductSecuritywebsite26
purchaser/customer

responsibilities15

H

hardware

customer-supplied26

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OptimaEMS

R

relateddocuments28

73

requirements

ITE15
patientvicinity15
service26

responsibilities

purchaser/customer15

revisionhistory2

S

safety

conventions

denitions14

hazards14

security

patches26
updates26

service

information26
requirements26

symbols

device16
packaging16

T

training23
typographicalconventions27

U

updates

security26

V

viruses26

74

OptimaEMS

2061274-003B

GEMedicalSystems
InformationTechnologies,Inc.
8200WestTowerAvenue
Milwaukee,WI53223USA
Tel:[phone]

[phone](USOnly)

Fax:[phone]

AsiaHeadquarters

GEMedicalSystems
InformationTechnologies,Inc.
Asia;GE(China)Co.,Ltd.
No.1HuatuoRoad
ZhangjiangHi-techParkPudong
Shanghai,People'sRepublicofChina201203
Tel:[phone]
Fax:[phone]

GEMedicalSystemsInformationTechnologies,Inc.,aGeneralElectricCompany,goingtomarketas
GEHealthcare.

www.gehealthcare.com