5415035-1EN Rev02 9800-9900 Regulatory Reference Chart PDF

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GE Healthcare

GE OEC 9800 - 9900


Regulatory Reference Chart

5415035-1EN
Rev 2
© 2011
GE OEC Medical Systems, Inc.
All Rights Reserved

Master in Document Control


GE OEC 9800–9900 Regulatory Reference Chart

Revision History
Rev Date Change Description
01 March 2011 Initial Release
02 Sept. 2011 Add countries to Table 1, Table 2

This manual may not be reproduced, in whole or in part, without the written permission of GE OEC Medical Systems, Inc.
OEC is a registered trademark of GE OEC Medical Systems, Inc. Other product and company names mentioned herein are the property of
their respective owners.
The contents of this document are accurate at the time of publication. However, changes in design and additional features can, at any time,
be incorporated in the hardware and software and may not be reflected in this version of the document. Contact GE OEC Technical Support
for clarification, if discrepancies arise.
GE OEC Medical Systems, Inc. a General Electric Company, going to market as GE Healthcare.

GE OEC Medical Systems, Inc. GE Medical Systems, SCS


384 Wright Brothers Drive 283, rue de la Minière
Salt Lake City, Utah 84116 U.S.A. 78530 Buc,
(801) 328-9300 France
Telephone: (+33) 1 30 70 40 40
Fax: (+33) 1 30 70 44 40

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GE OEC 9800–9900 Regulatory Reference Chart

Medical Device Directive

This product conforms with the Medical Device Directive, Council


Directive 93/42/EEC: June 14, 1993, following the provisions of
Annex II, when it bears the CE Mark of Conformity shown at left.

This symbol indicates that the waste of electrical and electronic


equipment must not be disposed as unsorted municipal waste and
must be collected separately. Contact an authorized representative
of the manufacturer for information concerning the
decommissioning of your equipment.

The separate collection symbol is affixed to a battery, or its


packaging, to advise you that the battery must be recycled or
disposed of in accordance with local or country laws. The letters
below the separate collection symbol indicate whether certain
elements (Pb=Lead, Cd=Cadmium, Hg=Mercury) are contained in the
battery. To minimize potential effects on the environment and
human health, it is important that all marked batteries that you
remove from the product are properly recycled or disposed.

For information on how the battery may be safely removed from the device, please consult the service
manual or equipment instructions. Information on the potential effects on the environment and
human health of the substances used in batteries is available at this url:
http://www.gehealthcare.com/euen/weee-recycling/index.html.

WARNING This Service Manual is available in English only.


(EN) If a customer's service provider requires a language other than English, it
is the customer's responsibility to provide translation services.
Do not attempt to service the equipment unless
this service manual has been consulted and is understood.
Failure to heed this warning may result in injury to the service provider,
operator, or patient from electric shock, or from mechanical or other
hazards.

AVISO Este manual de serviço só está disponível em inglês.


(PT-BR) Se algum provedor de serviço exigir este manual em outro idioma, será
responsabilidade do cliente fornecer os serviços de tradução.
Não tente fazer reparos no equipamento sem ter lido e entendido este
manual de serviço.
O não cumprimento deste aviso pode causar ferimentos no provedor de
serviço, no operador ou no paciente, como resultado de choque elétrico,
impacto mecânico ou outros perigos.

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ПРЕДУПРЕЖДЕНИЕ Това сервизно ръководство е налично само на английски език.


(BG) Ако доставчик на услуги на клиента изисква език, различен от
английски, клиентът отговаря за предоставянето на услугите за
превод.
Не се опитвайте да ремонтирате оборудването, ако не сте се
консултирали със и разбрали това сервизно ръководство.
Неспазването на това предупреждение може да доведе до
нараняване на доставчика на услуги, оператора или пациента от токов
удар, механични или други опасности.

警告 本维修手册仅提供英文版本。
(ZH-CN) 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。

警告 本維修手冊僅有英文版本。
(ZH-TW)
如顧客的維修服務提供者要求英文以外的語言,顧客有責任提供翻譯的
服務。
除非已查閱並瞭解本維修手冊,否則請勿嘗試維修設備。
未注意本警告可能導致維修服務提供者、操作人員或病患遭受到觸
電、機械或其他危害。

UPOZORENJE Ovaj servisni priručnik dostupan je samo na engleskom jeziku.


(HR) Ako davatelj usluge stranke traži neki drugi jezik, stranka će biti dužna
osigurati uslugu prijevoda.
Ne pokušavajte servisirati uređaj ako niste proučili i shvatili ovaj servisni
priručnik.
Nepridržavanjem ovog upozorenja može doći do tjelesne ozljede davatelja
usluge, rukovatelja ili pacijenta djelovanjem električnog udara ili zbog
mehaničkih ili drugih opasnosti.

VÝSTRAHA Tento provozní návod existuje pouze v anglickém jazyce.


(CS) V případě, že externí služba zákazníkům potřebuje návod v jiném jazyce, je
zajištění překladu do odpovídajícího jazyka úkolem zákazníka.
Nesnažte se o údržbu tohoto zařízení, aniž byste si přečetli tento provozní
návod a pochopili jeho obsah.
V případě nedodržování této výstrahy může dojít k poranění pracovníka
prodejního servisu, obslužného personálu nebo pacientů vlivem
elektrického proudu, respektive vlivem mechanických či jiných rizik.

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ADVARSEL Denne servicemanual findes kun på engelsk.


(DA) Hvis en kundes tekniker har brug for et andet sprog end engelsk, er det
kundens ansvar at sørge for oversættelse.
Forsøg ikke at servicere udstyret medmindre
denne servicemanual har været konsulteret og er forstået.
Manglende overholdelse af denne advarsel kan medføre skade på grund
af elektrisk, mekanisk eller anden fare for teknikeren, operatøren eller
patienten.
HOIATUS KÄESOLEV TEENINDUSJUHEND ON SAADAVAL AINULT INGLISE KEELES.
(ET) Kui klienditeenindaja nõuab juhendit mõnes muus keeles peale inglise, siis
vastutab klient tõlketeenuse osutamise eest.
Ärge üritage seadmeid hooldada enne käesolevast teenindusjuhendist aru
saamata ja sellega tutvumata.
Käesoleva hoiatuse eiramine võib põhjustada teenuseosutajale,
operaatorile või patsiendile vigastusi elektrilöögi, mehaanilise või muu ohu
tagajärjel.
WAARSCHUWING DEZE ONDERHOUDSHANDLEIDING IS ENKEL IN HET ENGELS
(NL) VERKRIJGBAAR.
ALS HET ONDERHOUDSPERSONEEL EEN ANDERE TAAL NODIG HEEFT, DAN
IS DE KLANT VERANTWOORDELIJK VOOR DE VERTALING ERVAN.
PROBEER DE APPARATUUR NIET TE ONDERHOUDEN VOORDAT DEZE
ONDERHOUDSHANDLEIDING IS GERAADPLEEGD EN BEGREPEN.
INDIEN DEZE WAARSCHUWING NIET WORDT OPGEVOLGD, ZOU HET
ONDERHOUDSPERSONEEL, DE OPERATOR OF EEN PATIËNT GEWOND
KUNNEN RAKEN ALS GEVOLG VAN EEN ELEKTRISCHE SCHOK OF DOOR
MECHANISCHE OF ANDERE RISICO'S.

VAROITUS TÄMÄ HUOLTO-OHJE ON SAATAVILLA VAIN ENGLANNIKSI.


(FI) Jos asiakkaan huoltohenkilöstö vaatii muuta kuin englanninkielistä
materiaalia, tarvittavan käännöksen hankkiminen on asiakkaan vastuulla.
Älä yritä korjata laitteistoa ennen kuin olet varmasti lukenut ja
ymmärtänyt tämän huolto-ohjeen.
Jos tätä varoitusta ei noudateta, seurauksena voi olla huoltohenkilöstön,
laitteiston käyttäjän tai potilaan vahingoittuminen sähköiskun,
mekaanisen vian tai muun vaaratilanteen vuoksi.
ATTENTION CE MANUEL DE MAINTENANCE N’EST DISPONIBLE QU’EN ANGLAIS.
(FR) SI LE TECHNICIEN DU CLIENT A BESOIN DE CE MANUEL DANS UNE AUTRE
LANGUE QUE L’ANGLAIS, C’EST AU CLIENT QU’IL INCOMBE DE LE FAIRE
TRADUIRE.
NE PAS TENTER D’INTERVENTION SUR LES ÉQUIPEMENTS TANT QUE LE
MANUEL DE MAINTENANCE N’A PAS ÉTÉ CONSULTÉ ET COMPRIS.
LE NON-RESPECT DE CET AVERTISSEMENT PEUT ENTRAÎNER CHEZ LE
TECHNICIEN, L’OPÉRATEUR OU LE PATIENT DES BLESSURES DUES À DES
DANGERS ÉLECTRIQUES, MÉCANIQUES OU AUTRES.

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WARNUNG Diese Serviceanleitung existiert nur in englischer Sprache.


(DE) Falls ein fremder Kundendienst eine andere Sprache benötigt, ist es
Aufgabe des Kunden für eine entsprechende Übersetzung zu sorgen.
Versuchen Sie nicht, diese Anlage zu warten,
ohne die Serviceanleitung gelesen und verstanden zu haben.
Wird diese Warnung nicht beachtet, so kann es zu Verletzungen des
Kundendiensttechnikers, des Bedieners oder des Patienten durch
Stromschläge, mechanische oder sonstige Gefahren kommen.

ΠΡΟΕΙ∆ΟΠΟΙΗΣΗ ΤΟ ΠΑΡΟΝ ΕΓΧΕΙΡΙ∆ΙΟ ΣΕΡΒΙΣ ∆ΙΑΤΙΘΕΤΑΙ ΣΤΑ ΑΓΓΛΙΚΑ ΜΟΝΟ.


(EL) ΕΑΝ ΤΟ ΑΤΟΜΟ ΠΑΡΟΧΗΣ ΣΕΡΒΙΣ ΕΝΟΣ ΠΕΛΑΤΗ ΑΠΑΙΤΕΙ ΤΟ ΠΑΡΟΝ
ΕΓΧΕΙΡΙ∆ΙΟ ΣΕ ΓΛΩΣΣΑ ΕΚΤΟΣ ΤΩΝ ΑΓΓΛΙΚΩΝ, ΑΠΟΤΕΛΕΙ ΕΥΘΥΝΗ ΤΟΥ
ΠΕΛΑΤΗ ΝΑ ΠΑΡΕΧΕΙ ΥΠΗΡΕΣΙΕΣ ΜΕΤΑΦΡΑΣΗΣ.
ΜΗΝ ΕΠΙΧΕΙΡΗΣΕΤΕ ΤΗΝ ΕΚΤΕΛΕΣΗ ΕΡΓΑΣΙΩΝ ΣΕΡΒΙΣ ΣΤΟΝ ΕΞΟΠΛΙΣΜΟ
ΕΚΤΟΣ ΕΑΝ ΕΧΕΤΕ ΣΥΜΒΟΥΛΕΥΤΕΙ ΚΑΙ ΕΧΕΤΕ ΚΑΤΑΝΟΗΣΕΙ ΤΟ ΠΑΡΟΝ
ΕΓΧΕΙΡΙ∆ΙΟ ΣΕΡΒΙΣ.
ΕΑΝ ∆Ε ΛΑΒΕΤΕ ΥΠΟΨΗ ΤΗΝ ΠΡΟΕΙ∆ΟΠΟΙΗΣΗ ΑΥΤΗ, ΕΝ∆ΕΧΕΤΑΙ ΝΑ
ΠΡΟΚΛΗΘΕΙ ΤΡΑΥΜΑΤΙΣΜΟΣ ΣΤΟ ΑΤΟΜΟ ΠΑΡΟΧΗΣ ΣΕΡΒΙΣ, ΣΤΟ ΧΕΙΡΙΣΤΗ
Ή ΣΤΟΝ ΑΣΘΕΝΗ ΑΠΟ ΗΛΕΚΤΡΟΠΛΗΞΙΑ, ΜΗΧΑΝΙΚΟΥΣ Ή ΑΛΛΟΥΣ
ΚΙΝ∆ΥΝΟΥΣ.

AÐVÖRUN ÞESSI ÞJÓNUSTUHANDBÓK ER EINGÖNGU FÁANLEG Á ENSKU.


(IS) Þarfnist þjónustuveitandi viðskiptamanns annars tungumáls en ensku, er
það á ábyrgð viðskiptamanns að bjóða upp á þýðingarþjónustu.
Reynið ekki að þjónusta búnaðinn fyrr en þessi þjónustuhandbók hefur
verið skoðuð og skilin.
Sé ekki farið eftir þessari viðvörun, getur það leitt til meiðsla á
þjónustuveitanda, notanda eða sjúklingi vegna raflosts, vélbúnaðar eða
öðrum hættum.

FIGYELMEZTETÉS EZEN KARBANTARTÁSI KÉZIKÖNYV KIZÁRÓLAG ANGOL NYELVEN ÉRHETŐ


(HU) EL.
HA A VEVŐ SZOLGÁLTATÓJA ANGOLTÓL ELTÉRŐ NYELVRE TART IGÉNYT,
AKKOR A VEVŐ FELELŐSSÉGE A FORDÍTÁS ELKÉSZÍTTETÉSE.
NE PRÓBÁLJA ELKEZDENI HASZNÁLNI A BERENDEZÉST, AMÍG A
KARBANTARTÁSI KÉZIKÖNYVBEN LEÍRTAKAT NEM ÉRTELMEZTÉK.
EZEN FIGYELMEZTETÉS FIGYELMEN KÍVÜL HAGYÁSA A SZOLGÁLTATÓ,
MŰKÖDTETŐ VAGY A BETEG ÁRAMÜTÉS, MECHANIKAI VAGY EGYÉB
VESZÉLYHELYZET MIATTI SÉRÜLÉSÉT EREDMÉNYEZHETI.

AVVERTENZA Il presente Manuale di servizio è disponibile soltanto in inglese.


(IT) Se un fornitore del servizio di assistenza del cliente richiede una lingua
diversa dall’inglese, è responsabilità del cliente fornire i servizi di
traduzione.
Provare ad intervenire sull’apparecchiatura solo dopo aver consultato e
compreso questo manuale di servizio.
La mancata osservanza di questa avvertenza potrebbe provocare lesioni
al tecnico dell’assistenza o al paziente, per scosse elettriche oppure per
pericoli di natura meccanica o altro.

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このサービスマニュアルは英語でのみ提供されています。
(JA) お客様のサービス担当者が英語以外の言語を必要とする場合、
翻訳作業の提供はお客様の責任となります。
このサービスマニュアルを熟読し理解してから、装置のサービスを
行なってください。
この警告に従わない場合、感電または、機械的もしくはその他の危険
要因により、サービス担当者、操作員、または患者が負傷する可能性
があります。
경고 본 서비스 지침서는 영어로만 이용하실 수 있습니다.
(KO)
고객의 서비스 제공자가 영어 이외의 언어를 요구할 경우, 번역 서비스를
제공하는 것은 고객의 책임입니다.
본 서비스 지침서를 참고했고 이해하지 않는 한은 해당 장비를
수리하려고 시도하지 마십시오.
이 경고에 유의하지 않으면 전기 쇼크, 기계상의 혹은 다른 위험으로부터
서비스 제공자, 운영자 혹은 환자에게 위해를 가할 수 있습니다.

BRĪDINĀJUMS ŠĪ APKALPES ROKASGRĀMATA IR PIEEJAMA TIKAI ANGĻU VALODĀ.


(LV) JA KLIENTA APKALPES SNIEDZĒJAM NEPIECIEŠAMA INFORMĀCIJA CITĀ
VALODĀ, NEVIS ANGĻU, KLIENTA PIENĀKUMS IR NODROŠINĀT TULKOŠANU.
NEVEICIET APRĪKOJUMA APKALPI BEZ APKALPES ROKASGRĀMATAS
IZLASĪŠANAS UN SAPRAŠANAS.
ŠĪ BRĪDINĀJUMA NEIEVĒROŠANA VAR RADĪT ELEKTRISKĀS STRĀVAS
TRIECIENA, MEHĀNISKU VAI CITU RISKU IZRAISĪTU TRAUMU APKALPES
SNIEDZĒJAM, OPERATORAM VAI PACIENTAM.

ĮSPĖJIMAS ŠIS EKSPLOATAVIMO VADOVAS YRA PRIEINAMAS TIK ANGLŲ KALBA.


(LT) JEI KLIENTO PASLAUGŲ TIEKĖJAS REIKALAUJA VADOVO KITA KALBA – NE
ANGLŲ, NUMATYTI VERTIMO PASLAUGAS YRA KLIENTO ATSAKOMYBĖ.
NEMĖGINKITE ATLIKTI ĮRANGOS TECHNINĖS PRIEŽIŪROS, NEBENT
ATSIŽVELGĖTE Į ŠĮ EKSPLOATAVIMO VADOVĄ IR JĮ SUPRATOTE.
JEI NEATKREIPSITE DĖMESIO Į ŠĮ PERSPĖJIMĄ, GALIMI SUŽALOJIMAI DĖL
ELEKTROS ŠOKO, MECHANINIŲ AR KITŲ PAVOJŲ PASLAUGŲ TIEKĖJUI,
OPERATORIUI AR PACIENTUI.

ADVARSEL DENNE SERVICEHÅNDBOKEN FINNES BARE PÅ ENGELSK.


(NO) HVIS KUNDENS SERVICELEVERANDØR TRENGER ET ANNET SPRÅK, ER DET
KUNDENS ANSVAR Å SØRGE FOR OVERSETTELSE.
IKKE FORSØK Å REPARERE UTSTYRET UTEN AT DENNE
SERVICEHÅNDBOKEN ER LEST OG FORSTÅTT.
MANGLENDE HENSYN TIL DENNE ADVARSELEN KAN FØRE TIL AT
SERVICELEVERANDØREN, OPERATØREN ELLER PASIENTEN SKADES PÅ
GRUNN AV ELEKTRISK STØT, MEKANISKE ELLER ANDRE FARER.

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OSTRZEŻENIE NINIEJSZY PODRĘCZNIK SERWISOWY DOSTĘPNY JEST JEDYNIE W JĘZYKU


(PL) ANGIELSKIM.
JEŚLI DOSTAWCA USŁUG KLIENTA WYMAGA JĘZYKA INNEGO NIŻ
ANGIELSKI, ZAPEWNIENIE USŁUGI TŁUMACZENIA JEST OBOWIĄZKIEM
KLIENTA.
NIE PRÓBOWAĆ SERWISOWAĆ WYPOSAŻENIA BEZ ZAPOZNANIA SIĘ I
ZROZUMIENIA NINIEJSZEGO PODRĘCZNIKA SERWISOWEGO.
NIEZASTOSOWANIE SIĘ DO TEGO OSTRZEŻENIA MOŻE SPOWODOWAĆ
URAZY DOSTAWCY USŁUG, OPERATORA LUB PACJENTA W WYNIKU
PORAŻENIA ELEKTRYCZNEGO, ZAGROŻENIA MECHANICZNEGO BĄDŹ
INNEGO.

ATENŢIE ACEST MANUAL DE SERVICE ESTE DISPONIBIL NUMAI ÎN LIMBA ENGLEZĂ.


(RO) DACĂ UN FURNIZOR DE SERVICII PENTRU CLIENŢI NECESITĂ O ALTĂ LIMBĂ
DECÂT CEA ENGLEZĂ, ESTE DE DATORIA CLIENTULUI SĂ FURNIZEZE O
TRADUCERE.
NU ÎNCERCAŢI SĂ REPARAŢI ECHIPAMENTUL DECÂT ULTERIOR
CONSULTĂRII ŞI ÎNŢELEGERII ACESTUI MANUAL DE SERVICE.
IGNORAREA ACESTUI AVERTISMENT AR PUTEA DUCE LA RĂNIREA
DEPANATORULUI, OPERATORULUI SAU PACIENTULUI ÎN URMA
PERICOLELOR DE ELECTROCUTARE, MECANICE SAU DE ALTĂ NATURĂ.

ОСТОРОЖНО! Данное руководство по обслуживанию предлагается только на


(RU) английском языке.
Если сервисноМУ ПЕРСОНАЛУ клиента необходимо руководство не на
английском, а на каком-то другом языке, клиенту следует
самостоятельно обеспечить перевод.
ПЕРЕД ОБСЛУЖИВАНИЕМ ОБОРУДОВАНИЯ ОБЯЗАТЕЛЬНО ОБРАТИТЕСЬ
К ДАННОМУ РУКОВОДСТВУ И ПОЙМИТЕ ИЗЛОЖЕННЫЕ В НЕМ
СВЕДЕНИЯ.
Несоблюдение требований данного предупреждения может привести к
тому, что специалист по обслуживанию, оператор или пациент получат
удар электрическим током, механическую травму или другое
повреждение.

UPOZORENJE Ovaj servisni priručnik dostupan je samo na engleskom jeziku.


(SR) Ako dobavljač usluga klijenta zahteva neki drugi jezik osim engleskog,
klijent snosi odgovornost za obezbeđivanje usluga prevođenja.
Nemojte pokušavati da servisirate opremu ako niste
pročitali i razumeli ovaj servisni priručnik.
Nepoštovanje ovog upozorenja može da izazove povrede za dobavljača
usluga, operatera ili pacijenta usled električnog udara ili mehaničkih i
drugih opasnosti.

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UPOZORNENIE Tento návod na obsluhu je k dispozícii len v ANGLIČTINE.


(SK) AK ZÁKAZNÍKOV POSKYTOVATEĽ SLUŽIEB VYŽADUJE INÝ JAZYK AKO
ANGLIČTINU, POSKYTNUTIE PREKLADATEĽSKÝCH SLUŽIEB JE
ZODPOVEDNOSŤOU ZÁKAZNÍKA.
NEPOKÚŠAJTE SA O OBSLUHU ZARIADENIA SKôR, AKO SI NEPREČÍTATE
NÁVOD NA OBSLUHU A NEPOROZUMIETE MU.
ZANEDBANIE TOHTO UPOZORNENIA MÔŽE VYÚSTIŤ DO ZRANENIA
POSKYTOVATEĽA SLUŽIEB, OBSLUHUJÚCEJ OSOBY ALEBO PACIENTA
ELEKTRICKÝM PRÚDOM, DO MECHANICKÉHO ALEBO INÉHO
NEBEZPEČENSTVA.

OPOZORILO Ta servisni priročnik je na voljo le v angleščini.


(SL) Če strankin ponudnik storitve potrebuje drug jezik, razen angleščine,
potem je stranka odgovorna, da zagotovi prevajalske storitve.
Ne poskusite opravljati servisiranja, če niste prebrali in razumeli tega
servisnega priročnika.
Če ne upoštevate to opozorilo, lahko pride do poškodb ponudnika storitve,
operaterja ali bolnika zaradi električnega udara ali mehanskih in drugih
nevarnosti.

¡ATENCIÓN! ESTE MANUAL DE SERVICIO SÓLO EXISTE EN INGLÉS.


(ES) SI ALGÚN PROVEEDOR DE SERVICIOS NECESITA UN IDIOMA QUE NO SEA EL
INGLÉS, ES LA RESPONSABILIDAD DEL CLIENTE DE OFRECER EL SERVICIO
DE TRADUCCIÓN.
NO DEBE DAR SERVICIO TÉCNICO AL EQUIPO SIN HABER CONSULTADO Y
COMPRENDIDO ESTE MANUAL DE SERVICIO.
NO OBSERVAR ESTE AVISO PUEDE DAR LUGAR A QUE EL PROVEEDOR DE
SERVICIOS, EL OPERADOR O EL PACIENTE SUFRA LESIONES PROVOCADAS
POR CAUSAS ELÉCTRICAS, MECÁNICAS O DE OTRA NATURALEZA.

VARNING DEN HÄR SERVICEHANDBOKEN FINNS BARA TILLGÄNGLIG PÅ ENGELSKA.


(SV) OM EN KUNDS SERVICETEKNIKER HAR BEHOV AV ETT ANNAT SPRÅK ÄN
ENGELSKA ANSVARAR KUNDEN FÖR ATT TILLHANDAHÅLLA
ÖVERSÄTTNINGSTJÄNSTER.
FÖRSÖK INTE UTFÖRA SERVICE PÅ UTRUSTNINGEN OM DU INTE HAR LÄST
OCH FÖRSTÅR DEN HÄR SERVICEHANDBOKEN.
OM DU INTE TAR HÄNSYN TILL DEN HÄR VARNINGEN KAN DET RESULTERA
I SKADOR PÅ SERVICETEKNIKERN, OPERATÖREN ELLER PATIENTEN TILL
FÖLJD AV ELEKTRISKA STÖTAR, MEKANISKA FAROR ELLER ANDRA FAROR.

DİKKAT BU SERVİS KILAVUZUNUN SADECE İNGİLİZCESİ MEVCUTTUR.


(TR) MÜŞTERİNİN HİZMET SAĞLAYICISI BAŞKA BİR DİLDE KILAVUZ TALEP
EDERSE, KILAVUZUN ÇEVRİLMESİNDEN MÜŞTERİ SORUMLU OLUR.
SERVİS KILAVUZUNU OKUYUP ANLAMADAN EKİPMANLARA MÜDAHALE
ETMEYİN.
BU UYARIYA UYULMAMASI, ELEKTRİK, MEKANİK VEYA DİĞER
TEHLİKELERDEN DOLAYI HİZMET SAĞLAYICININ, OPERATÖRÜN VEYA
HASTANIN YARALANMASINA YOL AÇABİLİR.

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GE OEC 9800–9900 Regulatory Reference Chart

ПОПЕРЕДЖЕННЯ Ця інструкція з технічного обслуговування доступна лише англійською


(UK) мовою.
Якщо організація, яка обслуговує клієнта, потребуватиме інструкцію на
іншій мові, до обов’язків клієнта входитиме забезпечення такого
перекладу.
Не намагайтеся здійснювати технічне обслуговування цього
обладнання, попередньо не ознайомившись із цією інструкцією та не
зрозумівши її.
Ігнорування цього попередження може призвести до поранень
персоналу обслуговуючої організації, оператора або пацієнта в
результаті удару електричним струмом або механічних чи інших видів
небезпек.

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Contents
Introduction ........................................................................................................................................................................... 1
Dose Rate Limit Settings ................................................................................................................................................. 1
UtilitySuite Settings ............................................................................................................................................................ 2
Dose Rate Limit Settings .............................................................................................................................................................. 4
UtilitySuite Settings ......................................................................................................................................................................... 6
Manufacturing Dose Rate Limit Settings in Units of R for USA .................................................................................. 9
Image Intensifier Dose Rate Regalatory Limits Independent of CINE Frame Rate and Without Grid ..... 9
Appendix A: UK ................................................................................................................................................................ 10
Appendix B: Israel ........................................................................................................................................................... 11

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Introduction
The following chart(s) lists the factory settings of a system destined for a certain country. The chart is
organized in rows by country, and split into two tables: Dose Rate Limit Settings and UtilitySuite
Settings.

You are responsible to be aware of local regulations that are different, and for countries that are not
listed below. In those cases, the system should be set to local regulations during install or service of
the system. Some countries have additional optional settings defined per country in the Appendices.

Dose Rate Limit Settings


See Table 1.
1. Patient Entrance Exposure Rates (EER): This is the Entrance Exposure Rate (or Entrance AKR)
limit. This is also called Skin Dose. This is what is measured 30cm above the image intensifier.
It is set with the mA Limit Editor in Utility Suite. Table 1 lists the EER Limit that is set in
manufacturing and the regulatory limit for each country (if applicable). The limits are listed for
standard fluoro and HLF modes. The limits are listed in units of mGy/min.
2. Image Intensifier Entrance Dose Rates for Iris Verification: Table 1 lists the manufacturing
range/limit and the regulatory limit for each country (if applicable). The manufacturing ranges
listed are first for 9” systems followed by 12”. Also listed is the HLF manufacturing limit. The
image intensifier entrance dose rates are listed in units of mGy/min.

The values in the tables are not used for I.I. Dose limit calibration. See the 9900 service manual
supplement manual or the 9800 service manual for the procedure for setting the II dose limits.
Note: The limits are verified in manufacturing in Continuous Normal Auto Fluoro, Continuous HLF, and
Digital CINE 25 or 30PPS modes, with two 1-mm copper filters over the collimator cover and the
dosimeter ion chamber centered directly on the image intensifier.
9800: If the ABS Table is set to Cardiac or Cardiac PT, temporarily change the ABS Table to what is
specified in Table 2, for the particular country, when measuring I.I. dose rates. Set the ABS Table back
to the original setting when finished.
9900: Use the General Profile (not Cardiac) when measuring I.I. dose rates. Return to original settings
when finished.

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UtilitySuite Settings
See Table 2.
The following settings are found in the “General Setup/Configuration” section in UtilitySuite:
1. Regulatory Group Type/ABS Tables: This is used to select the Domestic, International A, or
International B ABS table. It controls the dose to the image intensifier. On 9800 systems,
Cardiac and Cardiac PT ABS tables are also available for Cardiac systems (see note 9 for
further details). This is displayed in UtilitySuite as “Regulatory Group” for 9900, and “ABS
Tables” for 9800.
2. Fluoro Alarm Control Type: This controls the option to terminate x-rays after a set time
period.
3. Alarm Start Time: This controls the “Alarm Start Time” in seconds. The default is 295 seconds
(4 minutes 55 seconds).
4. Time Until Terminate: This sets the amount of time, in seconds, in addition to the alarm start
time, when a standard fluoro shot will terminate. This is set to 300 seconds (5 minutes) for
countries that have a 10-minute termination requirement.
5. Fluoro Beeper: This controls if the system emits an audible signal during exposures.
6. Terminate X-Rays: This controls whether the system terminates x-rays when the “Time Until
Terminate” time is reached.
7. HLF Alarm Timer: This sets the time, in seconds, for the maximum amount of time of an HLF
exposure.
8. Film Mode Enabled: This determines if the Film Mode feature is enabled.
9. HLF Enabled: This determines if the HLF feature is enabled.

Figure 1

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9800-9900 Regulatory Reference Chart

The following settings are found in the “GE OEC Personnel Privileged” section in Utility Suite:
1. Sync Rate: Sets video sync rate to either 30Hz or 25Hz
2. Dose Area Product Live Update: Determines if DAP is displayed.
3. Skin Dose Enable: Determines if Skin Dose is displayed.
4. Tube Type: Selects proper tube type.
For all 9900 systems: Select Tube Type 00-884653-01 Only
For 9800’s with tube model RAD-99: Select Tube Type 00-901318-02
For 9800’s with tube model RAD-99B: Select Tube Type 00-884653-01
Note: Tube model information can be found on the X-ray tube label located behind the swing down
panel on the C-Arm.

Figure 2

Figure 3
Note: For settings which use a checkbox to enable or disable the feature, a  in the table indicates
that this setting is enabled, while a  indicates that it is not enabled. The settings in the figures
above may not be specific for the particular system that is being configured. See the information
above and tables below to properly setup the system.

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Dose Rate Limit Settings


Table 1 - Dose Rate Limit Settings
Patient Entrance Exposure Image Intensifier Entrance Dose Rates
Rates (EER) (mGy/min) for Iris Verification (μGy/min)
Regulatory
Country MFG Limits1 Manufacturing Range2 Regulatory Limits3
Limits
Fluoro Range HLF Digital CINE Range
Std HLF Std HLF Std HLF CINE5
9” System 12” System Limit4 9” System 12” System
9” 101 9” 112 9” 112
Australia 46.3 135.0 50 150 18.0±2.2 13.0±2.3 254±39 184±31 N/A
12” 76 12” 84 12” 84
9” 101 9” 112 9” 112
New Zealand 46.3 90.0 50 100 31±4.2 22±3.3 254±39 184±31 N/A
12” 76 12” 84 12” 84
Japan 46.3 112.5 50 125 39±5 29±4 N/A 280±40 203±33 N/A N/A N/A
Brazil 46.3 158.4 50 N/A6 39±5 29±4 N/A 280±40 203±33 N/A N/A N/A
Ireland
81.5 90.0 1007 100 31±4.2 22±3.3 N/A 254±39 184±31 N/A N/A N/A
UK
Belgium
Italy 81.5 90.0 1007 100 31±4.2 22±3.3 76 254±39 184±31 67 84 421
Portugal
Mexico 81.5 90.0 1007 100 39±5 29±4 N/A 280±40 203±33 N/A N/A 9” 379
Canada 81.5 135.0 1007 150 39±5 29±4 N/A 280±40 203±33 N/A N/A N/A
Switzerland 81.5 158.4 88 176 31±4.2 22±3.3 76 254±39 184±31 84 84 N/A
USA8
81.5 158.4 88 176 39±5 29±4 N/A 280±40 203±33 N/A N/A N/A
Puerto Rico
Algeria
France 81.5 158.4 1007 2003 31±4.2 22±3.3 N/A 254±39 184±31 N/A N/A N/A
Morocco
Spain 81.5 158.4 1007 2003 31±4.2 22±3.3 76 254±39 184±31 67 84 421
India 81.5 158.4 1007 N/A5 31±4.2 22±3.3 N/A 254±39 184±31 N/A N/A N/A
Angola
Argentina
Bangladesh
Bosnia
Brunei
Bulgaria
Cambodia 81.5 158.4 N/A5 N/A5 31±4.2 22±3.3 N/A 254±39 184±31 N/A N/A N/A
Cameroon
Chad
China
Croatia
Cyprus
(continued)

1 The EER limits set during manufacturing are the regulatory limit minus 7.4% in Standard Fluoro and minus 10% in HLF to account for
dosimeter error and ion chamber positioning error.
2 As measured on top of the anti-scatter grid, with two 1mm copper filters in beam. For Fluoro and HLF, it is a continuous (non-pulsed) shot

in auto mode. For Digital CINE, it is either a 25PPS or 30PPS shot depending on the sync rate selected. All are normal magnification and
non-cardiac profile.
3 The limits, as stated by regulation, refer to the actual intensifier dose rate (see Table 4). The values stated in this column of Table 1 are

adjusted for a 72% grid transmission factor, and a 1% difference in distance between SID and Source to Grid distance. The result is the limit
as measured on top of the grid.
4 The dose to image intensifier HLF limit verified during manufacturing is the regulatory limit as measured on top of the grid minus 10% to

account for dosimeter error and ion chamber positioning error.


5 The limits for CINE mode, as stated by regulation, represent the intensifier dose per frame (see Table 4). The values stated in this column of

Table 1 represent dose rates and are calculated by multiplying the regulated dose per frame by the number of frames per minute. 25 FPS
(frame rate) is used for countries with a 25Hz sync rate, and 30FPS is used for countries with a 30Hz sync rate to convert to mGy/min.
6 These countries do not specify a dose at patient skin limits in the indicated mode. For these countries, the limit for manufacturing is the

same value as for USA.


7 Note that some countries have higher EER limits than the USA. For these countries, the limit for manufacturing is the same value as for

USA.
8 For reference purpose only, the USA limits expressed in units of R are in Table 3. The manufacturing dose rates were converted from mGy

to R using a conversion factor of 1R = 8.76mGy.

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9800-9900 Regulatory Reference Chart

Patient Entrance Exposure Image Intensifier Entrance Dose Rates


Rates (EER) (mGy/min) for Iris Verification (μGy/min)
Regulatory
Country MFG Limits1 Manufacturing Range2 Regulatory Limits3
Limits
Fluoro Range HLF Digital CINE Range
Std HLF Std HLF Std HLF CINE5
9” System 12” System Limit4 9” System 12” System
(continued)
Czech
Republic
Denmark
Ethiopia
Egypt
Estonia
Finland
Georgia
Gabon
Ghana
Greece
Greenland
Hong Kong
Hungary
Iceland
Indonesia
Iraq
Israel
Jordan
Kenya
Kuwait
Laos
Latvia
Lebanon
Libya
Lithuania
Luxembourg
Macedonia
Malaysia 81.5 158.4 N/A5 N/A5 31±4.2 22±3.3 N/A 254±39 184±31 N/A N/A N/A
Malta
Montenegro
Netherlands
Nigeria
Norway
Oman
Pakistan
Papua New-
Guinea
Paraguay
Poland
Romania
Russia
Rwanda
Senegal
Serbia
Singapore
Slovakia
Slovenia
South Africa
Sudan
Sweden
Thailand
Tunisia
Turkey
UAE
Ukraine
Uruguay
Vietnam
Austria
Germany 81.5 158.4 N/A5 N/A5 31±4.2 22±3.3 N/A 254±39 184±31 51 N/A 421

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9800-9900 Regulatory Reference Chart

Patient Entrance Exposure Image Intensifier Entrance Dose Rates


Rates (EER) (mGy/min) for Iris Verification (μGy/min)
Regulatory
Country MFG Limits1 Manufacturing Range2 Regulatory Limits3
Limits
Fluoro Range HLF Digital CINE Range
Std HLF Std HLF Std HLF CINE5
9” System 12” System Limit4 9” System 12” System
Bahamas
Bermuda
Bolivia
Chile
Colombia
Costa Rica
Guatemala
Haiti
Honduras
Jamaica 81.5 158.4 N/A5 N/A5 39±5 29±4 N/A 280±40 203±33 N/A N/A N/A
Panama
Peru
Philippines
Saudi Arabia
South Korea
Taiwan
Trinidad &
Tobago
Venezuela

UtilitySuite Settings
Table 2 - UtilitySuite Settings
Fluoro Alarm
Group / ABS

Alarm Start
Table Type9

Timer (sec)
Time Until
Terminate

Terminate

HLF Alarm

Film Mode

Live Update
Dose Area

Skin Dose
Enabled

Enabled
Control

Beeper

X-Rays
Fluoro

Product

Enable
Time
Type

Sync
Rate
(sec)

(sec)
Reg.

HLF
Country

Bolivia
Brazil
Chile
Colombia
Guatemala
Honduras
Jamaica Dom Intl 295 300   30   30  
Panama
Philippines
Taiwan
Trinidad &
Tobago
Venezuela
Bermuda
Haiti
Peru Dom Intl 295 300   30   30  
Saudi Arabia
South Korea
Bahamas
Canada
Costa Rica
Dom U.S. 295 N/A   30   30  
Japan
Mexico
(continued)

9 For 9800, if the system configuration is Cardiac, choose Cardiac ABS Table instead of Domestic, and Cardiac PT ABS Table instead of
International A or B.

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Fluoro Alarm
Group / ABS

Alarm Start
Table Type9

Timer (sec)
Time Until
Terminate

Terminate

HLF Alarm

Film Mode

Live Update
Dose Area

Skin Dose
Enabled

Enabled
Control

Beeper

X-Rays
Fluoro

Product

Enable
Time
Type

Sync
Rate
(sec)

(sec)
Reg.

HLF
Country

(continued)
Puerto Rico Dom U.S. 295 N/A   30   30  
USA
Algeria
Angola
Argentina
Austria
Bosnia
Brunei Bulgaria
Cambodia
Cameroon
Chad
Croatia
Cyprus
Czech Republic
Denmark
Egypt
Estonia
Ethiopia
Finland
France
Gabon
Georgia
Germany
Ghana
Greece
Greenland
Hungary
Iceland
Indonesia
Iraq
Ireland Intl A Intl 295 300   30   25  
Jordan
Kenya
Kuwait
Laos
Latvia
Lebanon
Libya
Lithuania
Luxembourg
Macedonia
Malaysia
Malta
Montenegro
Morocco
Netherlands
Nigeria
Norway
Oman
Pakistan
Papua New-
Guinea
Paraguay
Poland
Romania
Russia
Rwanda
Senegal
(continued)

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9800-9900 Regulatory Reference Chart

Fluoro Alarm
Group / ABS

Alarm Start
Table Type9

Timer (sec)
Time Until
Terminate

Terminate

HLF Alarm

Film Mode

Live Update
Dose Area

Skin Dose
Enabled

Enabled
Control

Beeper

X-Rays
Fluoro

Product

Enable
Time
Type

Sync
Rate
(sec)

(sec)
Reg.

HLF
Country

(continued)
Serbia
Slovakia
Slovenia
South Africa
Sudan
Sweden
Intl A Intl 295 300   30   25  
Tunisia
Turkey
UAE
UK
Ukraine
Uruguay
Vietnam
Bangladesh
China
Hong Kong
Intl A Intl 295 300   30   25  
Israel
Singapore
Thailand
India Intl A U.S. 295 N/A   30   25  
Belgium
Italy
Intl A Intl 295 300   30   25  
Portugal
Spain
New Zealand Intl A Intl 295 300   20   25  
Switzerland Intl A Intl 295 300   20   25  
Australia Intl B Intl 295 300   20   25  

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Manufacturing Dose Rate Limit Settings in Units of R for


USA
Table 3 - Manufacturing Dose Rate Limit Settings in Units of R for USA
Patient Entrance Exposure Rates (EER) (R/min) Image Intensifier Entrance Dose Rates for Iris Verification (mR/min)
Fluoro Digital CINE
Std HLF
9” System 12” System 9” System 12” System
9.30 18.08 4.5±0.6 3.3±0.5 32±4.6 23±3.8

Image Intensifier Dose Rate Regalatory Limits Independent


of CINE Frame Rate and Without Grid
Table 4 - Image Intensifier Dose Rate Regulatory Limits
Independent of CINE Frame Rate and Without Grids
Country Std. (μGy/min) HLF (μGy/min) CINE6 (μGy/frame)
Australia 9” 80 9” 80
N/A
New Zealand 12” 60 12” 60
Austria
36 N/A 0.20
Germany
Belgium
Italy
48 60 0.20
Portugal
Spain
Mexico N/A N/A 0.15
Switzerland 60 60 N/A

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Appendix A: UK
The configuration described in this Appendix is appropriate for use in the UK. All of the settings listed
in the table must be used when using the optional settings. These settings can be utilized to reduce
the x-ray dose. A side effect of using this configuration is reduced image quality.
Table 5 – Optional Dose Rate Limit Settings for the UK
Patient Entrance Exposure Image Intensifier Entrance Dose Rates
Rates (EER) (mGy/min) for Iris Verification (μGy/min)
Regulatory
Country MFG Limits1 Manufacturing Range2 Regulatory Limits3
Limits
Fluoro Range HLF Digital CINE Range
Std HLF Std HLF Std HLF CINE5
9” System 12” System Limit4 9” System 12” System
UK 81.5 90.0 1007 100 18.0±2.2 13.0±2.3 N/A 254±39 184±31 N/A N/A N/A

Table 6 – Optional UtilitySuite Settings for the UK


Fluoro Alarm
Group / ABS

Alarm Start

Timer (sec)
Table Type

Time Until
Terminate

Terminate

HLF Alarm

Film Mode

Live Update
Dose Area

Skin Dose
Enabled

Enabled
Control

Beeper

X-Rays
Fluoro

Product

Enable
Time
Type

Sync
Rate
(sec)

(sec)
Reg.

HLF
Country

UK Intl B Intl 295 300   30   25  

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Appendix B: Israel
The configuration described in this Appendix is appropriate for use in Israel. All of the settings listed in
the table must be used when using the optional settings. These settings can be utilized to reduce the
x-ray dose. A side effect of using this configuration is reduced image quality.
Table 7 – Optional Dose Rate Limit Settings for Israel
Patient Entrance Exposure Image Intensifier Entrance Dose Rates
Rates (EER) (mGy/min) for Iris Verification (μGy/min)
Regulatory
Country MFG Limits1 Manufacturing Range2 Regulatory Limits3
Limits
Fluoro Range HLF Digital CINE Range
Std HLF Std HLF Std HLF CINE5
9” System 12” System Limit4 9” System 12” System
Israel 81.5 158.4 N/A N/A 39±5 29±4 N/A 280±40 203±33 N/A N/A N/A

Table 8 – Optional UtilitySuite Settings for the Israel


Fluoro Alarm
Group / ABS

Alarm Start

Timer (sec)
Table Type

Time Until
Terminate

Terminate

HLF Alarm

Film Mode

Live Update
Dose Area

Skin Dose
Enabled

Enabled
Control

Beeper

X-Rays
Fluoro

Product

Enable
Time
Type

Sync
Rate
(sec)

(sec)
Reg.

HLF
Country

Israel Dom Intl 295 300   30   30  

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