OEC One Service Manual SM 6888001-1EN 5

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OEC OneTM

Mobile C-arm X-ray Product

Service Manual

6888001-1EN
Rev.5
© 2019
General Electric Company
All Rights Reserved
OEC One Mobile C-arm X-ray Product

Revision History
Revision Date (Month & Year) Description of Change
1 Aug. 2017 Initial Release
2 Oct. 2017 Update information
3 Jun. 2018 Update information
Oct. 2018 1. Update version 2 system UI information;
2. Add cine and DSA & Road map options information;
4 3. Add wireless and wired foots witch information;
4. Add GESAK information;
5. Add new FRUs information.
5 Jan. 2019 1.Update information: section 3.8.6 video distributor, section 3.8.7
Advanced wireless module, section 3.8.10 cine and DSA & Road map;

IMPORTANT SAVE THESE INSTRUCTIONS. PLEASE READ THIS MANUAL BEFORE USING OEC One Mobile C-Arm X-ray Product.
This manual may not be reproduced, in whole or in part, without the written permission of GE Healthcare.
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 Healthcare Technical Support for clarification, if discrepancies arise.
The text of this manual was originally written, approved and published by the manufacturer in English.
GE HUALUN Medical Systems Co. Ltd., a General Electric company, going to market as GE Healthcare.

GE HUALUN Medical Systems Co. Ltd


No. 1 Yongchang North Road
Beijing Economic & Technological Development Area
Beijing, P.R. China 100176
Tel: 8610-58068888
Fax: 8610-67881850

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OEC One Mobile C-arm X-ray Product

REGULATORY REQUIREMENTS
International Electrotechnical Commission (IEC), international standards organization, when applicable.
This product conforms with the Medical Device Directive, Council Directive 93/42/EEC: June 14, 1993, as
amended by 2007/47/EC following the provisions of Annex II, when it bears the following CE Mark of
Conformity.

EU Authorized Representative:
GE Medical Systems S.C.S.
283 rue de la Minière
78530 BUC France
Tel: +33 1 30 70 40 40

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OEC One Mobile C-arm X-ray Product

The list of below is Essential Characteristic, it can provide essential indicator.


NOTE

SEC Table
EC# Description Location
EC1 Leakage current test Section 3.6.3 and Section 8.4.6
EC2 Ground continuity test Section 3.6.3 and Section 8.4.5
EC3 System emergency switch function test Section 3.7.4 and Section 8.7.5
EC4 System functional Check Section 3.7 and Section 8.7
EC5 Power indicator LED check Section 3.6
EC6 ABS auto technique tracking Section 3.7.9 and Section 8.12
EC7 Monoblock replacement Section 7.4
EC8 I.I. replacement Section 7.4
EC9 Battery performance check Section 8.6
EC10 Image resolution check Section 3.7.10 and Section 8.17
EC11 Dose check Section 3.7.6 and Section 8.13
EC12 Beam alignment calibration Section 4.6
EC13 Image calibration Section 4.11, 4.12, 4.13 and 4.15
EC14 Spring arm replacement Section 7.4

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OEC One Mobile C-arm X-ray Product

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, mechanical or other hazards.
ПРЕДУПРЕЖДЕНИЕ Това упътване за работа е налично само на английски език.
(BG) Ако доставчикът на услугата на клиента изиска друг език, задължение на клиента е да
осигури превод.
Не използвайте оборудването, преди да сте се консултирали и разбрали упътването за
работа.
Неспазването на това предупреждение може да доведе до нараняване на доставчика
на услугата, оператора или пациентa в резултат на токов удар, механична или друга
опасност.
警告 本维修手册仅提供英文版本。
(ZH-CN) 如果客户的维修服务人员需要非英文版本,则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服务人员、操作人员或患者造成电击、机械伤害或其他形式的伤害。

警告 本服務手冊僅提供英文版本。
(ZH-HK) 倘若客戶的服務供應商需要英文以外之服務手冊,客戶有責任提供翻譯服務。
除非已參閱本服務手冊及明白其內容,否則切勿嘗試維修設備。
不遵從本警告或會令服務供應商、網絡供應商或病人受到觸電、機械性或其他的危險。

警告 本維修手冊僅有英文版。
(ZH-TW) 若客戶的維修廠商需要英文版以外的語言,應由客戶自行提供翻譯服務。
請勿試圖維修本設備,除非 您已查閱並瞭解本維修手冊。
若未留意本警告,可能導致維修廠商、操作員或病患因觸電、機械或其他危險而受傷。

UPOZOENJE Ovaj servisni priručnik dostupan je na engleskom jeziku.


(HR) Ako davatelj usluge klijenta treba neki drugi jezik, klijent je dužan osigurati prijevod.
Ne pokušavajte servisirati opremu ako niste u potpunosti pročitali i razumjeli ovaj servisni
priručnik.
Zanemarite li ovo upozorenje, može doći do ozljede davatelja usluge, operatera ili pacijenta
uslijed strujnog udara, mehaničkih ili drugih rizika.
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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OEC One Mobile C-arm X-ray Product

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 uden at læse og forstå denne servicemanual.
Manglende overholdelse af denne advarsel kan medføre skade på grund af elektrisk stød,
mekanisk eller anden fare for teknikeren, operatøren eller patienten.
WAARSCHUWING Deze onderhoudshandleiding is enkel in het Engels verkrijgbaar.
(NL) Als het onderhoudspersoneel een andere taal vereist, dan is de klant verantwoordelijk voor
de vertaling ervan.
Probeer de apparatuur niet te onderhouden alvorens deze onderhoudshandleiding werd
geraadpleegd en begrepen is.
Indien deze waarschuwing niet wordt opgevolgd, zou het onderhoudspersoneel, de operator
of een patiënt gewond kunnen raken als gevolg van een elektrische schok, mechanische of
andere gevaren.
HOIATUS See teenindusjuhend on saadaval ainult inglise keeles
(ET) Kui klienditeeninduse osutaja nõuab juhendit inglise keelest erinevas keeles, vastutab klient
tõlketeenuse osutamise eest.
Ärge üritage seadmeid teenindada enne eelnevalt käesoleva teenindusjuhendiga tutvumist ja
sellest aru saamist.
Käesoleva hoiatuse eiramine võib põhjustada teenuseosutaja, operaatori või patsiendi
vigastamist elektrilöögi, mehaanilise või muu ohu tagajärjel.
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.
Mikäli tätä varoitusta ei noudateta, seurauksena voi olla huoltohenkilöstön, laitteiston
käyttäjän tai potilaan vahingoittuminen sähköiskun, mekaanisen vian tai muun vaaratilanteen
vuoksi.
ATTENTION Ce manuel d’installation et de maintenance est disponible uniquement en anglais.
(FR) Si le technicien d'un client a besoin de ce manuel dans une langue autre que l'anglais, il
incombe au client de le faire traduire.
Ne pas tenter d'intervenir sur les équipements tant que ce manuel d’installation et 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.
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 diese 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.

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OEC One Mobile C-arm X-ray Product

ΠΡΟΕΙΔΟΠΟΙΗΣΗ Το παρόν εγχειρίδιο σέρβις διατίθεται μόνο στα αγγλικά.


(EL) Εάν ο τεχνικός σέρβις ενός πελάτη απαιτεί το παρόν εγχειρίδιο σε γλώσσα εκτός των
αγγλικών, αποτελεί ευθύνη του πελάτη να παρέχει τις υπηρεσίες μετάφρασης.
Μην επιχειρήσετε την εκτέλεση εργασιών σέρβις στον εξοπλισμό αν δεν έχετε συμβουλευτεί
και κατανοήσει το παρόν εγχειρίδιο σέρβις.
Αν δεν προσέξετε την προειδοποίηση αυτή, ενδέχεται να προκληθεί τραυματισμός στον
τεχνικό σέρβις, στο χειριστή ή στον ασθενή από ηλεκτροπληξία, μηχανικούς ή άλλους
κινδύνους.
FIGYELMEZTETÉS Ezen karbantartási kézikönyv kizárólag angol nyelven érhető el.
(HU) 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.
AÐVÖRUN Þessi þjónustuhandbók er aðeins fáanleg á ensku.
(IS) Ef að þjónustuveitandi viðskiptamanns þarfnast annas tungumáls en ensku, er það skylda
viðskiptamanns að skaffa tungumálaþjónustu.
Reynið ekki að afgreiða tækið nema að þessi þjónustuhandbók hefur verið skoðuð og skilin.
Brot á sinna þessari aðvörun getur leitt til meiðsla á þjónustuveitanda, stjórnanda eða
sjúklings frá raflosti, vélrænu eða öðrum áhættum.
AVVERTENZA Il presente manuale di manutenzione è disponibile soltanto in lingua inglese.
(IT) Se un addetto alla manutenzione richiede il manuale in una lingua diversa, il cliente è tenuto
a provvedere direttamente alla traduzione.
Procedere alla manutenzione dell'apparecchiatura solo dopo aver consultato il presente
manuale ed averne compreso il contenuto.
Il mancato rispetto della presente avvertenza potrebbe causare lesioni all'addetto alla
manutenzione, all'operatore o ai pazienti provocate da scosse elettriche, urti meccanici o altri
rischi.

(JA)

경고 본서비스매뉴얼은영어로만이용하실수있습니다 .
(KO) 고객의서비스제공자가영어이외의언어를요구할경우 , 번역서비스를제공하는것은고객의책임
입니다 .
본서비스매뉴얼을 참조하여숙지하지않은이상해당장비를수리하려고시도하지마십시오 .
본경고사항에유의하지않으면전기쇼크 , 기계적위험 , 또는기타위험으로인해서비스제공자 , 사
용자또는환자에게부상을입힐수있습니다 .
RĪDINĀJUMS Šī apkopes rokasgrāmata ir pieejama tikai angļu valodā.
(LV) Ja klienta apkopes sniedzējam nepieciešama informācija citā valodā, klienta pienākums ir
nodrošināt tulkojumu.
Neveiciet aprīkojuma apkopi bez apkopes rokasgrāmatas izlasīšanas un saprašanas.
Šī brīdinājuma neievērošanas rezultātā var rasties elektriskās strāvas trieciena, mehānisku
vai citu faktoru izraisītu traumu risks apkopes sniedzējam, operatoram vai pacientam.

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OEC One Mobile C-arm X-ray Product

ĮSPĖJIMAS Šis eksploatavimo vadovas yra tik anglų kalba.


(LT) Jei kliento paslaugų tiekėjas reikalauja vadovo kita kalba – ne anglų, suteikti vertimo
paslaugas privalo klientas.
Nemėginkite atlikti įrangos techninės priežiūros, jei neperskaitėte ar nesupratote šio
eksploatavimo vadovo.
Jei nepaisysite šio įspėjimo, galimi paslaugų tiekėjo, operatoriaus ar paciento sužalojimai dėl
elektros šoko, mechaninių ar kitų pavojų.
ADVARSEL Denne servicehåndboken finnes bare på engelsk.
(NO) Hvis kundens serviceleverandør har bruk for 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.
OSTRZEŻENIE Niniejszy podręcznik serwisowy dostępny jest jedynie w języku angielskim.
(PL) Jeśli serwisant klienta wymaga języka innego niż angielski, zapewnienie usługi tłumaczenia
jest obowiązkiem klienta.
Nie próbować serwisować urządzenia bez zapoznania się z niniejszym podręcznikiem
serwisowym i zrozumienia go.
Niezastosowanie się do tego ostrzeżenia może doprowadzić do obrażeń serwisanta,
operatora lub pacjenta w wyniku porażenia prądem elektrycznym, zagrożenia
mechanicznego bądź innego.
AVISO Este manual de assistência técnica encontra-se disponível unicamente em inglês.
(PT-BR) Se outro serviço de assistência técnica solicitar a tradução deste manual, caberá ao cliente
fornecer os serviços de tradução.
Não tente reparar o equipamento sem ter consultado e compreendido este manual de
assistência técnica.
A não observância deste aviso pode ocasionar ferimentos no técnico, operador ou paciente
decorrentes de choques elétricos, mecânicos ou outros.
ATENÇÃO Este manual de assistência técnica só se encontra disponível em inglês.
(PT-PT) Se qualquer outro serviço de assistência técnica solicitar este manual noutro idioma, é da
responsabilidade do cliente fornecer os serviços de tradução.
Não tente reparar o equipamento sem ter consultado e compreendido este manual de
assistência técnica.
O não cumprimento deste aviso pode colocar em perigo a segurança do técnico, do operador
ou do paciente devido a choques eléctricos, mecânicos ou outros.
ATENŢIE Acest manual de service este disponibil doar 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.

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OEC One Mobile C-arm X-ray Product

ОСТОРОЖНО! Данное руководство по техническому обслуживанию представлено 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 техническим обслуживанием оборудования обязательно обратитесь к данному
руководству и поймите изложенные в нем сведения.
Несоблюдение требований данного предупреждения может привести к тому, что
специалист по техобслуживанию, оператор или пациент получит удар электрическим
током, механическую травму или другое повреждение.
UPOZORENJE Ovo servisno uputstvo je dostupno samo na engleskom jeziku.
(SR) Ako klijentov serviser zahteva neki drugi jezik, klijent je dužan da obezbedi prevodilačke
usluge.
Ne pokušavajte da opravite uređaj ako niste pročitali i razumeli ovo servisno uputstvo.
Zanemarivanje ovog upozorenja može dovesti do povređivanja servisera, rukovaoca ili
pacijenta usled strujnog udara ili mehaničkih i drugih opasnosti.
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, kým si neprečítate návod na obluhu a neporozumiete
mu.
Zanedbanie tohto upozornenia môže spôsobiť zranenie poskytovateľa služieb, obsluhujúcej
osoby alebo pacienta elektrickým prúdom, mechanické alebo iné ohrozenie.
ATENCION Este manual de servicio sólo existe en inglés.
(ES) Si el encargado de mantenimiento de un cliente necesita un idioma que no sea el inglés, el
cliente deberá encargarse de la traducción del manual.
No se deberá dar servicio técnico al equipo, sin haber consultado y comprendido este
manual de servicio.
La no observancia del presente aviso puede dar lugar a que el proveedor de servicios, el
operador o el paciente sufran 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.
OPOZORILO Ta servisni priročnik je na voljo samo v angleškem jeziku.
(SL) Če ponudnik storitve stranke potrebuje priročnik v drugem jeziku, mora stranka zagotoviti
prevod.
Ne poskušajte servisirati opreme, če tega priročnika niste v celoti prebrali in razumeli.
Če tega opozorila ne upoštevate, se lahko zaradi električnega udara, mehanskih ali drugih
nevarnosti poškoduje ponudnik storitev, operater ali bolnik.
DİKKAT Bu servis kılavuzunun sadece ingilizcesi mevcuttur.
(TR) Eğer müşteri teknisyeni bu kılavuzu ingilizce dışında bir başka lisandan talep ederse, bunu
tercüme ettirmek müşteriye düşer.
Servis kılavuzunu okuyup anlamadan ekipmanlara müdahale etmeyiniz.
Bu uyarıya uyulmaması, elektrik, mekanik veya diğer tehlikelerden dolayı teknisyen, operatör
veya hastanın yaralanmasına yol açabilir.

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Content
Chapter 1 Introduction and Safety .......................................................................................................1-1
1.1 Introduction ............................................................................................................................................................... 1-2
1.1.1 Objective ................................................................................................................................................................ 1-2
1.1.2 Scope ....................................................................................................................................................................... 1-2
1.1.3 Service philosophy ............................................................................................................................................ 1-2
1.1.4 Qualifications ....................................................................................................................................................... 1-2
1.1.5 Unauthorized Modifications ......................................................................................................................... 1-2
1.1.6 Manual Organization and Use ..................................................................................................................... 1-2
1.2 Safety ........................................................................................................................................................................... 1-4
1.2.1 Safety Hazard Alerts ......................................................................................................................................... 1-4
1.2.2 Ingress of Fluids .................................................................................................................................................. 1-4
1.2.3 Electrical Shock ................................................................................................................................................... 1-5
1.2.4 Explosion ................................................................................................................................................................ 1-5
1.2.5 Thermal Hazards ................................................................................................................................................ 1-6
1.2.6 Equipment Stability ........................................................................................................................................... 1-6
1.2.7 Radiation ................................................................................................................................................................ 1-6
1.2.8 Motorized Mechanical Movement ............................................................................................................. 1-6
1.2.9 Work on Parts with Lead Material ............................................................................................................. 1-7
1.2.10 Safety Interlock ................................................................................................................................................ 1-7
1.2.11 Labels ................................................................................................................................................................... 1-7
1.2.12 Locations of the Labels ..............................................................................................................................1-23
1.2.13 Symbols .............................................................................................................................................................1-25
1.2.14 Electromagnetic Compatibility Statement ........................................................................................1-26
1.2.15 Lock-Out, Tag-Out ........................................................................................................................................1-34
Chapter 2 System Overview ...................................................................................................................2-1
2.1 System Descriptions .............................................................................................................................................. 2-2
2.2 System Components Overview ........................................................................................................................ 2-4
Chapter 3 Installation ...............................................................................................................................3-1
3.1 Overview ..................................................................................................................................................................... 3-2

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OEC One Mobile C-arm X-ray Product

3.2 Pre-Installation ........................................................................................................................................................ 3-2


3.2.1 Dimensions and Weights of System ......................................................................................................... 3-2
3.2.2 Site Requirement ................................................................................................................................................ 3-2
3.2.3 Power Supply Requirement ........................................................................................................................... 3-3
3.2.4 Environments ....................................................................................................................................................... 3-3
3.2.5 Tools and Test Equipment ............................................................................................................................. 3-4
3.3 Unpacking .................................................................................................................................................................. 3-5
3.3.1 Shipping Container Inspection .................................................................................................................... 3-5
3.3.2 Unpacking System ............................................................................................................................................ 3-6
3.4 Transport the System .........................................................................................................................................3-15
3.5 System Inspection ................................................................................................................................................3-18
3.5.1 Label Inspection ...............................................................................................................................................3-18
3.5.2 External Inspection .........................................................................................................................................3-20
3.5.3 Internal Inspection ..........................................................................................................................................3-21
3.5.4 Battery Pack Check .........................................................................................................................................3-22
3.6 System Setup ..........................................................................................................................................................3-23
3.6.1 Power Supply Adaption .................................................................................................................................3-23
3.6.2 Power On/Off .....................................................................................................................................................3-26
3.6.3 Facility Leakage Current and Ground Continuity Test Notification ..........................................3-28
3.6.4 System Configuration in Administration ...............................................................................................3-29
3.6.5 System Configuration in User Setup Interface ...................................................................................3-38
3.6.6 DICOM Setup and Check ..............................................................................................................................3-41
3.6.7 DICOM Worksheet ...........................................................................................................................................3-47
3.6.8 Printer ....................................................................................................................................................................3-51
3.7 Functional Check ..................................................................................................................................................3-53
3.7.1 System Movement Check ............................................................................................................................3-53
3.7.2 Mechanical Movement Check ...................................................................................................................3-54
3.7.3 Vertical Column Operation Check ............................................................................................................3-56
3.7.4 System Control Check ....................................................................................................................................3-57
3.7.5 System Operation Check..............................................................................................................................3-64
3.7.6 Dose Limitation Check ...................................................................................................................................3-68

2
OEC One Mobile C-arm X-ray Product

3.7.7 Beam Alignment Check ................................................................................................................................3-69


3.7.8 Collimator Iris Calibration Check ..............................................................................................................3-69
3.7.9 ABS Tracking Check ........................................................................................................................................3-69
3.7.10 Image Resolution Check ............................................................................................................................3-70
3.7.11 DAP Accuracy Check ...................................................................................................................................3-70
3.7.12 System Status Backup ................................................................................................................................3-70
3.7.13 Fill in the product Locator Card ..............................................................................................................3-70
3.7.14 GESAK Not Installed Check .......................................................................................................................3-70
3.8 Options Installation ..............................................................................................................................................3-71
3.8.1 Laser Aimer .........................................................................................................................................................3-71
3.8.2 Film Cassette Holder ......................................................................................................................................3-76
3.8.3 Removable Filter and Sensor Installation ............................................................................................3-77
3.8.4 Removable Grid ................................................................................................................................................3-79
3.8.5 Tube Skin Spacer .............................................................................................................................................3-81
3.8.6 Video Distributor ................................................................................................................ 3-82
3.8.7 Advanced Wireless Module ............................................................................................... 3-85
3.8.8 Wireless Footswitch ...................................................................................................................................3-105
3.8.9 Wired Foot switch .........................................................................................................................................3-110
3.8.10 Cine and DSA & Road Map .....................................................................................................................3-111
3.9 Room Interface ......................................................................................................................................................3-116
3.9.1 Enable Room Interface in Software UI ................................................................................................3-116
3.9.2 Room Interface Definition .........................................................................................................................3-117
3.10 Reporting ................................................................................................................................................................3-122
3.11 Installation Checklist .........................................................................................................................................3-122
Chapter 4 Calibration A .............................................................................................................................4-1
4.1 Overview ..................................................................................................................................................................... 4-2
4.2 kVp & mA Accuracy and Calibration ............................................................................................................. 4-4
4.2.1 kVp Measurement and Accuracy ............................................................................................................... 4-4
4.2.2 kVp Calibration .................................................................................................................................................... 4-5
4.2.3 mA Measurement and Accuracy ................................................................................................................ 4-7
4.2.4 mA Calibration .................................................................................................................................................... 4-9

3
OEC One Mobile C-arm X-ray Product

4.3 Preheat mA Calibration ......................................................................................................................................4-11


4.4 mAs Measurement and Calibration .............................................................................................................4-13
4.4.1 mAs Measurement and Accuracy Check .............................................................................................4-13
4.4.2 mAs Calibration ................................................................................................................................................4-13
4.5 X-ray Generator Warm-Up ..............................................................................................................................4-14
4.6 Beam Alignment ....................................................................................................................................................4-15
4.6.1 Camera Centering Check and Calibration ...........................................................................................4-15
4.6.2 Collimator Centering Accuracy and Calibration ...............................................................................4-17
4.7 BAFT/UBAT Installation and Alignment ......................................................................................................4-18
4.8 I.I. Field Size Check and Calibration ..............................................................................................................4-19
4.9 Collimator Check and Calibration .................................................................................................................4-20
4.10 ABS Tracking Check and Adjustment .......................................................................................................4-24
4.11 Image Resolution Check .................................................................................................................................4-26
4.12 Camera Focus Calibration .............................................................................................................................4-27
4.13 Image Intensifier Focus Calibration ..........................................................................................................4-27
4.14 Dose Accuracy Check and DAP Calibration ..........................................................................................4-28
4.14.1 DAP Calibration Check ................................................................................................................................4-28
4.14.2 DAP Calibration ............................................................................................................................................4-30
4.15 Uniformity Calibration ......................................................................................................................................4-32
4.16 Monitor Brightness and Contrast Adjustment ......................................................................................4-35
4.16.1 Keys assignment and operation LED ...................................................................................................4-35
4.16.2 Lock and unlock the OSD menu .............................................................................................................4-36
4.16.3 Key Functions in the OSD Menu .............................................................................................................4-36
4.16.4 Brightness and Contrast Adjustment ..................................................................................................4-37
4.16.5 Colour Temperature Selection ..............................................................................................................4-38
4.16.6 Calibration Curve Selection ......................................................................................................................4-38
4.16.7 Check and Configure Software UI .........................................................................................................4-40
4.16.8 Information and Input Source .................................................................................................................4-42
4.16.9 Restore Factory Settings ............................................................................................................................4-43
Chapter 5 Software ...................................................................................................................................5-1
5.1 Overview ..................................................................................................................................................................... 5-2

4
OEC One Mobile C-arm X-ray Product

5.1.1 General Description .......................................................................................................................................... 5-2


5.1.2 Software Version Compatibility Matrix .................................................................................................... 5-2
5.1.3 Service mode access control and GESAK ............................................................................................. 5-3
5.2 Service Mode ............................................................................................................................................................ 5-4
5.2.1 System Information ....................................................................................................................................... 5-4
5.2.2 Product Config .................................................................................................................................................... 5-5
5.2.3 Calibration ............................................................................................................................................................. 5-5
5.2.4 Exposure Config ................................................................................................................................................. 5-5
5.2.5 Imaging Config ................................................................................................................................................... 5-6
5.2.6 Maintenance ........................................................................................................................................................ 5-7
5.2.7 Log Viewer ............................................................................................................................................................ 5-8
5.3 Software Installation and Upgrade ................................................................................................................ 5-9
Chapter 6 Troubleshooting ......................................................................................................................6-1
6.1 Overview ..................................................................................................................................................................... 6-2
6.2 Error Recovery Steps ............................................................................................................................................. 6-2
6.3 Troubleshooting Guide ....................................................................................................................................... 6-3
6.3.1 System Boot up Display .................................................................................................................................. 6-3
6.3.2 System Shut Down Display ........................................................................................................................... 6-4
Chapter 7 Replacement .............................................................................................................................7-1
7.1 FRU list ......................................................................................................................................................................... 7-2
7.2 Locations of FRU ..................................................................................................................................................... 7-6
7.3 Replacement Overview ........................................................................................................................................ 7-9
7.3.1 Calibration Matrix ............................................................................................................................................7-10
7.3.2 Calibration Tool Matrix ..................................................................................................................................7-11
7.4 Replacement ..............................................................................................................................................................7-12
7.4.1 Tighten Torque and Thread Locker .........................................................................................................7-12
7.4.2 System Covers and Remove .......................................................................................................................7-16
7.4.3 Computer Internal Equipment ...................................................................................................................7-17
7.4.4 System Power and HV Power Filter .........................................................................................................7-18
7.4.5 DC Power Supply ..............................................................................................................................................7-19
7.4.6 IGBT Inverter Module .....................................................................................................................................7-19

5
OEC One Mobile C-arm X-ray Product

7.4.7 DC Bus Capacitor .............................................................................................................................................7-20


7.4.8 Rectifier Bridge ..................................................................................................................................................7-21
7.4.9 Power Management Unit .............................................................................................................................7-21
7.4.10 Tablet Control Panel ....................................................................................................................................7-22
7.4.11 Monitor and Exposure Indicator ............................................................................................................7-23
7.4.12 Monitor Spring Arm ......................................................................................................................................7-24
7.4.13 Monitor Cable ..................................................................................................................................................7-25
7.4.14 Battery Pack ....................................................................................................................................................7-26
7.4.15 Bundle Cable ...................................................................................................................................................7-26
7.4.16 Collimator and Monoblock .......................................................................................................................7-27
7.4.17 Image Intensifier, Image Intensifier Power Supply and Camera ............................................7-28
7.4.18 PCB Box Board ................................................................................................................................................7-29
7.4.19 kV Control Board ...........................................................................................................................................7-29
7.4.20 Updown Board ...............................................................................................................................................7-30
7.4.21 Fuse Collector .................................................................................................................................................7-31
Chapter 8 Periodic Maintenance ..............................................................................................................8-1
8.1 Overview .................................................................................................................................................................... 8-2
8.1.1 Safety ....................................................................................................................................................................... 8-2
8.1.2 Tools and Test Equipment .......................................................................................................................... 8-4
8.2 PM Checklist ............................................................................................................................................................. 8-5
8.3 Administrative Information ............................................................................................................................... 8-6
8.4 Safety Inspection ................................................................................................................................................... 8-6
8.4.1 Anti-static Drag Wires ..................................................................................................................................... 8-6
8.4.2 Electrical Plug And Power Cord ................................................................................................................... 8-6
8.4.3 Footswitch Cable And Pins ............................................................................................................................ 8-6
8.4.4 Bundle Cables ...................................................................................................................................................... 8-7
8.4.5 Ground Continuity ............................................................................................................................................. 8-7
8.4.6 Facility Leakage Current Test Notification ............................................................................................. 8-7
8.5 System Internal Clean ........................................................................................................................................ 8-8
8.5.1 Computer Clean ................................................................................................................................................. 8-8
8.5.2 Filter Clean ............................................................................................................................................................ 8-9

6
OEC One Mobile C-arm X-ray Product

8.6 Battery Performance Check ...........................................................................................................................8-10


8.6.1 System Battery Pack Performance check ............................................................................................8-10
8.6.2 Computer Cell Battery Check .....................................................................................................................8-10
8.7 Functional Checks ...............................................................................................................................................8-11
8.7.1 System Movement Check ............................................................................................................................8-11
8.7.2 Mechanical Movement Check ...................................................................................................................8-11
8.7.3 Power On/Off Check .......................................................................................................................................8-15
8.7.4 Vertical Column Operation Check ............................................................................................................8-16
8.7.5 System Control Check ...................................................................................................................................8-16
8.7.6 System Operation Check ..............................................................................................................................8-16
8.7.7 DICOM Operation Check ...............................................................................................................................8-17
8.8 X-ray Generator Accuracy Check ................................................................................................................8-17
8.8.1 kVp Accuracy Check .......................................................................................................................................8-17
8.8.2 mA Accuracy Check ........................................................................................................................................8-17
8.8.3 mAs Accuracy Check .....................................................................................................................................8-17
8.9 Beam Alignment Check ....................................................................................................................................8-18
8.10 Field Size Check .................................................................................................................................................8-18
8.11 Collimator Check ...............................................................................................................................................8-18
8.12 ABS Tracking Check .........................................................................................................................................8-19
8.13 Dose Rate Check ...............................................................................................................................................8-19
8.14 Dose Limitation Check ....................................................................................................................................8-19
8.15 DAP Accuracy Check .......................................................................................................................................8-19
8.16 Uniformity Calibration ....................................................................................................................................8-19
8.17 Image Resolution Check ................................................................................................................................8-20
8.18 Options Functional Check .............................................................................................................................8-20
8.19 System Status Backup ....................................................................................................................................8-20
8.20 Reporting ..............................................................................................................................................................8-20
8.20.1 Install Equipment Covers ...........................................................................................................................8-20
8.20.2 Complete PM Comments ...........................................................................................................................8-20
Chapter 9 Technical Reference .................................................................................................................9-1
9.1 Overview ..................................................................................................................................................................... 9-2

7
OEC One Mobile C-arm X-ray Product

9.2 System Specifications ........................................................................................................................................... 9-2


9.2.1 Classification Type ............................................................................................................................................. 9-2
9.2.2 Environmental Requirements ...................................................................................................................... 9-2
9.2.3 Power Requirements ........................................................................................................................................ 9-3
9.2.4 Physical Specifications .................................................................................................................................... 9-4
9.3 Specification of key Components ................................................................................................................... 9-7
9.3.1 X-ray Generator .................................................................................................................................................. 9-7
9.3.2 X-ray Source Assembly .................................................................................................................................9-10
9.3.3 Others ....................................................................................................................................................................9-12
9.4 Tube Rating Chart ................................................................................................................................................9-13
9.4.1 Filament Emission Characteristics ...........................................................................................................9-13
9.4.2 Single Load Ratings ........................................................................................................................................9-14
9.5 Tube Thermal Characteristic ...........................................................................................................................9-15
9.6 Room Interface (RIF) ............................................................................................................................................9-16
9.7 Options .....................................................................................................................................................................9-17
9.7.1 Laser Aimer .........................................................................................................................................................9-17
9.7.2 30 cm Skin Spacer ...........................................................................................................................................9-19
9.7.3 Film Cassette Holder ......................................................................................................................................9-19
9.7.4 Video Distributor ..............................................................................................................................................9-19
9.7.5 Removable Grid ................................................................................................................................................9-20
9.7.6 Removable Filter ..............................................................................................................................................9-21
9.7.7 Wireless Module ...............................................................................................................................................9-21
9.7.8 Wireless Switch .................................................................................................................................................9-23
9.7.9 Cine and DAS&Roadmap .............................................................................................................................9-23
9.8 Material Recycling ............................................................................................................................................9-23
9.9 Replacement Parts ...........................................................................................................................................9-24
9.10 System Block ........................................................................................................................................................9-25

8
OEC One Mobile C-arm X-ray Product

9
Chapter 1 Introduction and Safety
OEC One Mobile C-arm X-ray Product

1.1 Introduction
1.1.1 Objective
Provide OEC One mobile C-arm X-ray product service documentation that is consistently organized, easy
to access and is designed to aggressively expedite fault isolation and decrease product down-time.

1.1.2 Scope
This manual’s contents document the necessary information for service.

1.1.3 Service philosophy


OEC One mobile C-arm X-ray products use precision components and utilize complex manufacturing
techniques. Component-level repairs that maintain compliance with these requirements are sometimes
not possible in the field. The system is therefore designed to be field serviceable at the modular or Field
Replaceable Unit (FRU) level.

1.1.4 Qualifications
Reading this manual does not qualify an untrained person to service the equipment. This publication
assumes the reader is a skilled and fully qualified electronic technician who has experience servicing
medical imaging systems. Factory trained service personnel will benefit the most from this material.

1.1.5 Unauthorized Modifications


GE HUALUN Medical Systems, Inc. certifies that when assembled according to the manufacturer's
instructions, this equipment meets applicable international standards. Unauthorized modifications to the
equipment may impact adherence to these standards and make the equipment unsafe to operate.
The owner is responsible for verifying continued compliance with all applicable regulations and standards.
Consult local, state, federal and/or international agencies regarding specific requirements and regulations
applicable to the use of this type of medical electronic equipment.

1.1.6 Manual Organization and Use


The information documented here has been analyzed and divided into several sections. This manual
contains the following types of information:
• Introduction and Safety-Information of the system and safety.
• System Overview-General description of the system and subsystem. The subsystems have been
analyzed and divided into functional sections. Each functional section contains major assembly and
control locations, theory, functional tests and other information relevant at the subsystem level.
• Installation Procedure –Information of pre-installation, unpacking and installation check.
• Calibration-Procedures for tuning and calibration relevant at the subsystem and system level.
• Software Maintenance- Provides procedures for software maintenance and service mode utilities.

1-2
Introduction and Safety

• Troubleshooting- Provides error code, error messages, and diagnostic programs that expedite the
diagnostic process.
• Replacement- Removal and installation procedures for fuses, covers and field replaceable units.
• Periodic Maintenance Procedure-Procedures for periodic maintenance.
• Technique Reference-Technical Reference of the system.

1-3
OEC One Mobile C-arm X-ray Product

1.2 Safety
Potential hazards exist in the use of medical electronic devices and X-ray systems. Operators using the
equipment should understand the safety issues, emergency procedures, and the operating instructions
provided.
The following pages describe hazardous and potentially hazardous conditions, and how to adequately
protect yourself and others from possible injury.

1.2.1 Safety Hazard Alerts


There are three hazard classifications, which are denoted and prioritized by the alert words :

WARNING indicates a potentially hazardous situation that, if not avoided, could result in
WARNING death or serious injury.

CAUTION indicates a potentially hazardous situation that, if not avoided, may result in
C A U T IO N
moderate to minor injury, equipment damage or loss of data.

NOTE is given in situation requiring special attention.


NOTE

1.2.2 Ingress of Fluids


Excessive amounts of fluids such as antiseptics, cleaning solutions or bodily fluids may damage internal
components.
The equipment is not rated for water-tight operation. Do not allow any liquids to leak into
WARNING the equipment where they can cause electric shock, fires, and short circuits. If leakage does
occur, ensure that all internal circuitry is completely dry before attempting to operate
the equipment.

Never store or operate the system in the presence of conductive fluids like water or saline
WARNING solution unless the system is adequately protected by an approved bagging or draping
system.

1-4
Introduction and Safety

1.2.3 Electrical Shock


Equipment that contains high power electrical components must be serviced only by
WARNING personnel familiar with proper safety procedures for working near these components.

Disconnect AC power (and battery packs if used) before discharging static electricity in
WARNING components such as electrolytic capacitors and high voltage cables. Failure to heed this
message will result in death or severe personal injury.
Allow adequate time for static charges to discharge through bleeder resistors. Use a high
WARNING wattage resistor when discharging circuits to avoid burns.

Have someone watch while you work near high voltages. This person must remain clear of
WARNING all circuitry and be prepared to turn off the power to the system and render aid in an
emergency.

High voltage cables and electrolytic capacitors can retain a dangerous static charge for long
WARNING periods after power has been removed. Some devices can acquire a charge spontaneously
without direct contact with other circuitry. Do not touch these components
unless power has been completely removed and they have been discharged.

Never operate the system unless all safety ground wires (green wire with a yellow stripe) and
C A U T IO N
related components are fastened in place. Dangerous electrical shock and improper
equipment operation can otherwise result.

Remove all metal rings and watchbands before working on system circuitry. Skin burns and
C A U T IO N
damage from involuntary muscle contractions can result if metal jewelry shorts electrical
circuits.

1.2.4 Explosion
If an abnormal condition occurs, such as the room fills with flammable gas, steps must be taken to prevent
the gas from gaining contact components within the equipment. Follow these guidelines:
1. Do not turn the system on or off.

2. Do not un-plug or plug-in system or peripheral equipment power cords.

3. Do not operate light switches or other electrical equipment.

4. Evacuate all personnel immediately.

5. Notify the hospital administration and/or fire department.

6. Ventilate the room to clear the air of all flammable vapor or gas.

7. Identify and remove the source of the flammable liquid, vapor, or gas.

1-5
OEC One Mobile C-arm X-ray Product

1.2.5 Thermal Hazards


Before removing the cover of the system for maintenance or service, please pay attention
WARNING to the points with high temperature, for example, the current limiters, internal power
distribute circuit etc. Otherwise it may harm your hands or body.

1.2.6 Equipment Stability

OEC One Mobile C-arm X-ray Product is mounted on wheels. And if it is moved or operated improperly it
could roll out of control. Follow these guidelines:
People should maintain control of the equipment when moving up or down an incline.
Place all mechanical assemblies in their most compact (transport) position and lock brake handles prior to
moving the equipment.
Use the handles designed for moving the equipment and mechanical assemblies.
Never attempt to move the system up or down steps.
Do not operate the equipment on unlevel floors.
Do not lock the wheel brakes and leave the equipment unattended on unlevel floors.
Always apply the wheel locks when the system is in its final position.
Do not move the equipment if the castors or wheels are not functioning properly.
Mechanical shocks to the equipment while hard disks are accessing information may cause
WARNING damage to the hard disk and loss of data.

1.2.7 Radiation
This equipment either produces or is used in the vicinity of ionizing radiation. Observe proper
C A U T IO N safety practices during operation. Use lead aprons, eye protection, thyroid protection, and
similar devices to protect yourself and others.

Where local patient entrance dose rate limitation value per regulation is lower than GE dose
C A U T IO N
group setting, the system dose group setting shall follow local patient entrance dose rate.

1.2.8 Motorized Mechanical Movement


OEC One Mobile C-arm X-ray Product has motorized mechanical assemblies. Please follow these guidelines:
Always observe mechanical assemblies when operating the motor to avoid pinching or collision with a
person or object.
Use care when working around equipment to avoid unintentional motor actuation. Do not carelessly place
objects on the equipment or bump or lean against the equipment.
Observe and prevent articles of clothing from getting caught in moving parts.

1-6
Introduction and Safety

1.2.9 Work on Parts with Lead Material


OEC One Mobile C-arm X-ray Product has parts with touchable lead material. They are Monoblock, Image
Intensifier, Image Intensifier cover, lead ring of collimator and collimator cover.
When working on those parts, Do Not directly touch the lead material.
C A U T IO N

1.2.10 Safety Interlock


Never bypass, remove jumper, or otherwise disable any equipment safety feature.
WARNING

1.2.11 Labels
External Labels

Even though this manual is supplied only in English, some labels may have a foreign
NOTE language equivalent that will appear on your system.

Item Label Quantity Description


OEC One system label indicates
manufacture information and input
power requirements.

1 1

X-ray Generator label indicates


manufacture information and product’s
technical parameters.

2 1

1-7
OEC One Mobile C-arm X-ray Product

Item Label Quantity Description


Image intensifier label indicates model
number and manufacture date.

3 1

Beam limiting device label indicates


model number and manufacture date.

4 1

Laser aiming device label indicates


model number and manufacture date.

5 1

Tube end laser positioning device


nameplate provides the model, the date
of production and other information.

6 1

Skin spacer label indicates model


number and manufacture date.
7 1

1-8
Introduction and Safety

Item Label Quantity Description


Spot film device label indicates model
number and manufacture date.

8 1

Removable filter label indicates model


number and manufacture date.
9 1

Removable grid label indicates model


number and manufacture date.
10 1

Video distributor label indicates model


number and manufacture date.
11 1

Horizontal Wig-Wag Indication Label


The label indicates the horizontal Wig-
Wag brake’s position of the C-arm.
1 Rotate the handle to the unlock position
12 to enable the Wig-Wag movement of
the C-arm. Rotate the handle to the lock
position to lock the Wig-Wag movement
of the C-arm.

Lateral Rotation Motion Indication Scale


(Left)
The label indicates the lateral rotation
brake’s position of the C-arm. Rotate the
handle to the unlock position to release
13 1
the brake. Rotate the handle to the lock
position to lock the lateral rotation
movement.

1-9
OEC One Mobile C-arm X-ray Product

Item Label Quantity Description

Lateral Rotation Motion Indication Scale


(Right)
The label indicates the lateral rotation
brake’s position of the C-arm. Rotate the
14 1 handle to the unlock position to release
the brake. Rotate the handle to the lock
position to lock the lateral rotation
movement.

Orbital Motion Indication Label (Left)


The label indicates the orbital rotation
15 brake’s position of the C-arm. Rotate the
handle to the unlock position to release
the brake. Rotate the handle to the lock
1 position to lock the orbital rotate
movement.

Orbital Motion Indication Label (Right)


The label indicates the orbital rotation
brake’s position of the C-arm. Rotate the
handle to the unlock position to release
1 the brake. Rotate the handle to the lock
position to lock the orbital rotate
16
movement.

Horizontal Motion Indication Label


The label indicates the horizontal across
arm brake’s position of the C-arm.
Rotate the handle to the unlock position
17 1 to release the brake. Rotate the handle
to the lock position to lock the horizontal
movement.

1-10
Introduction and Safety

Item Label Quantity Description

Potential equalization terminal label.


The label is located next to potential
1 equalization terminal of the system. It
18
indicates the potential equalization
terminal position of the system.
This label on the footswitch means that
the degree of protection of the
footswitch is IPX8. The electrical
19 1 mechanism within the footswitch is
protected from the effects of continuous
immersion in water.

Emergency Switch Label


This label near the emergency switch
20 indicates the location of Emergency
1 Switch.

CE Label
This label indicates the equipment was
tested by a Notified Body and was found
21 1 to be in compliance with the
0459 requirements of all relevant directives
and standards in effect within the
European Union at the time of
manufacture.

WEEE CSA Label


Left side of this label indicates that
waste electronic and electrical equip-
ment must not be disposed of as
unsorted municipal waste and must be
collected separately. Please contact an
authorized representative of the manu-
22 1 facturer for information concerning the
decommissioning of your equipment.
Right side of this label indicates the sys-
tem was tested by CSA authorized body
and it was found to be in compliance
with the requirements of all relevant
directives and standards at the time of
manufacture.

1-11
OEC One Mobile C-arm X-ray Product

Item Label Quantity Description

23 2 This is the label of branding.

X-ray Sources Label


This label can be found on the X-ray
generator. It indicates the location of the
X-ray source and the controls used to
24 1
produce ionizing Radiation. Use
appropriate precautions and protective
equipment when using the system and
at all times when X-rays are present.

System weight label


25 1 The label indicates the system weight.

WIFI label
The WIFI label with FCC/IC ID. Only
available when you choose Wi-Fi
26 1 Internet Adapter option for some
configuration.

Circuit Breaker Rating Label


The label indicates the Circuit Breaker
rating or other over current protector
27 1 used in power supply for this product
should meet the requirements.

1-12
Introduction and Safety

Item Label Quantity Description

Transport Position Warning label


The label indicates the position during
transporting the system.
Before moving the system, move the C-
arm to the lowest position, then move
the C-arm horizontally to the position
28 1 closest to the console and lock the
horizontal handle. Place C-arm in the
middle of the swing and lock the C-arm,
Check all parts are in the lock position.
Place the monitor in the monitor handle,
check the monitor spring arm brake
handle is in lock position. Then move the
system, refer to chapter 3.
Keep feet away from this area.

29 1

Monoblock Heat Label


Prolong use or long exposures can make
30 2 the monoblock very hot, the label warns
the operator to be careful so as not to
get burned.

Shut Down Warning Label


The Label is located next to the power
on key of the system. It indicates the
correct steps to shut down and restart
31 1
the system to avoid data loss.

1-13
OEC One Mobile C-arm X-ray Product

Item Label Quantity Description


Pay attention to keep your hands/
fingers away from this area.

32 8

External Device Interface Warning


Label
This label is located next to the external
device interface. It indicates that the
33 1 operator should not touch the
connector and the patient at the same
time. The connector must be connected
to the appointed device only.

Laser Aimer Warning Label


The label is located on the laser aimer
that is on the image intensifier. It
34 1
indicates the laser radiation hazard and
laser wavelength and power.

Laser Aimer Warning Label


The label is located on the laser aimer
that is on the image intensifier. It
35 1 indicates the operator laser reflector's
effect on the image.

Laser Aimer Warning Label


The label is located on the laser aimer
that is on the image intensifier. It
36 1 indicates the laser radiation hazard.

1-14
Introduction and Safety

Item Label Quantity Description

Laser Aimer WEEE label


This label indicates that electronic and
electrical equipment waste must not be
disposed of as unsorted municipal
waste and must be collected separately.
37 1 Please contact an authorized
representative of the manufacturer for
information concerning the
decommissioning of your equipment.

Laser Aimer warning label


The label is located on the laser aimer
that is on the monoblock. It indicates the
1 laser hazard.
38

Laser Warning Label


The label is located on the laser aimer
that is on the monoblock. It indicates the
39 1 laser aimer radiation hazard.

Boot warning label


The label is located next to the power
on/off button. It indicates that system
40 1
may fail to boot if USB device is not
removed.

1-15
OEC One Mobile C-arm X-ray Product

Item Label Quantity Description

X-ray Warning Label.


The label is located on the generator.
During system exposure, operating
41 1 instructions should be followed.

Storage Label On Footswitch.


The label is located next to the image’s
42 storage button. Pressing the button will
1
save the monitor’s left area image.

Footswitch Fluoro Mode Label


The label is located on the left side of the
43 1 footswitch. Press the button. The left
side’s exposure mode is the fluoro
mode.

Footswitch HLF Mode Label.

44 1 The label is located on the right side of


the footswitch. The right side’s exposure
mode is the HLF mode.

Monitor Spring arm warning Label.


The label is located on the monitor’s
spring arm. It reminds the operator to
45 1 use handles to move the monitor, and
do not run into the C-arm. Otherwise, it
will cause the damage to the system,
patient, or the operator.

Horizontal Cross-arm Left Scale


The label is located on the horizontal
46 1 cross-arm. It is used to help the operator
locate the horizontal cross-arm position
of the C-arm.

1-16
Introduction and Safety

Item Label Quantity Description

Horizontal Cross-arm Right Scale


The label is located on the horizontal
1 cross-arm. It is used to help the operator
47
locate the horizontal cross-arm position
of the C-arm.

Lateral Rotation Moving Scale


The label is located next to lateral
48 1 rotation moving brake handle. It is used
to help the operator locate the lateral
rotation position of the C-arm.

Horizontal Wig-Wag Scale


The label is located next to horizontal
Wig-Wag brake handle, is used to help
49 the operator locate the horizontal Wig-
1 Wag position of the C-arm.

Horizontal Wig-Wag Arrow


The label is located below horizontal
Wig-Wag scale. It is used to indicate the
50 1 horizontal wig-wag scale’s 0-point
position.

Horizontal Cross Arm Arrow


The label is located below horizontal
cross-arm left scale and horizontal
cross-arm right scale. It is used to
51 indicate the horizontal cross-arm
2
scale’s 0-point position.

1-17
OEC One Mobile C-arm X-ray Product

Item Label Quantity Description

Lateral Rotation Arrow


The label is located below lateral
rotation moving scale. It is used to
indicate the lateral rotation moving
52 scale’s 0-point position.
1

Orbital Motion Arrow (Left)


The label is located on the left side of
53 1 the Orbital Motion Indication Label. It is
used to indicate the C-arm orbital
motion scale’s 0-point position.

Orbital Motion Arrow (Right)


The label is located on the right side of
54 1 the Orbital Motion Indication Label. It is
used to indicate the C-arm orbital
motion scale’s 0-point position.

Wireless device label


This label is located next to the wireless
55 1 network switch to indicate the location
of the wireless network switch.

56 1 Patient Position Label

Swing Arm Label.


This label indicates the position of the
horizontal swing motion brake. When
the handle is rotated to the unlock
57 1 position, the brake can be released and
then the swing arm can move. When
the handle is rotated to the locked
position, the horizontal swing motion is
braked.

1-18
Introduction and Safety

Item Label Quantity Description

Unique Device Identifier (UDI). Every


medical device has a unique marking
for identification. It is attached on the
mainframe base cover.
Note that this is only an example of a
UDI marking.
The characters used in the UDI marking
represent specific identifiers.
Device identifier:
• (01) = GS1 global trade item
number (GTIN) of the device.
58 1
• 00840682125604 = Global trade
item number.
Production identifiers:
• (11) = GS1 application identifier for
the manufacturing date of the device
• 161200= Manufacturing date:
year-month-day (YYMMDD) with DD
always equal to 00
• (21) = GS1 application identifier for
the serial number of the device.
BB6SS1600000HL = Serial number.

21 CFR Variance Approval Label


This product is in conformity with
performance standards for fluoroscopic
59 1 equipment under 21CFR 1020.32
except with respect to those
characteristics authorized by Variance
Number 2018-V-0624 effective March
15,2018.

Footswitch with 5m cable


60 1 (only available in version 2 series
system)

1-19
OEC One Mobile C-arm X-ray Product

Item Label Quantity Description

Footswitch with 10m cable


61 1 (only available in version 2 series
system)

Wireless Footswitch
62 1 (only available in version 2 series
system)

Wireless Footswitch Receiver


63 1 Certification Label
(only available in version 2 series
system)

Wireless Footswitch Transmitter


64 1 Certification Label
(only available in version 2 series
system)

1-20
Introduction and Safety

Internal Labels

Item Label Quantity Description


1

Label, CQHL
1
Collimator Label

Label, DVI
1
Collector

Label, PLC
1
camera GE1020C

1 Label, 0.8mm Al

Label, J1 Terminal
1
Definition

1-21
OEC One Mobile C-arm X-ray Product

Item Label Quantity Description


6
Label, DC Bus
1
Fuse Label

1 Mark A

Label, Capacitor
1
Warning

9
1 F3 Fuse

10
Label, Battery
1
Fuse

1-22
Introduction and Safety

1.2.12 Locations of the Labels

1-23
OEC One Mobile C-arm X-ray Product

1-24
Introduction and Safety

1.2.13 Symbols
Be familiar with the following symbols that may appear on equipment and schematics so you can safely
maintain and operate the system:

Dangerous Voltage
This symbol identifies areas where hazardous voltages may be present. Use appropriate
safety precautions.

Protective Earth Ground


This symbol identifies the system’s main protective earth ground terminal, which connects
to the facility earth ground through the grounding prong on the AC power plug. This
connection must be in place at all times for safe system operation.
Earth Ground Connection
This symbol identifies an earth ground connection that is necessary to maintain grounding
throughout the system.

X-ray Source
This X-ray Source symbol is used to identify controls that will produce ionizing X-radiation
when activated. Always use appropriate safety precautions when generating X-rays.

This X-ray Source symbol is used to identify controls that will produce ionizing X-radiation
when activated. Always use appropriate safety precautions when generating X-rays.
Potential Equalization Terminal
This symbol identifies system terminals which, when connected together, are at the same
potential (not necessarily earth ground). Green/yellow wires normally connect potential
equalization terminals together.
Attention
Attention, see accompanying documentation for information. You can refer to this manual
for the operation instructions.

Type B
This symbol indicates the equipment is protected against electric shock by a protective
earth ground connection.

Ionization Radiation
This symbol indicates that there is ionization radiation.

Battery warning
A warning indicating referring to information stated in the accompanying documents.
Batteries are intended to be changed only by service personnel. Replacement by
inadequately trained personnel could result in a hazard (such as excessive temperatures,
fire or explosion)

1-25
OEC One Mobile C-arm X-ray Product

1.2.14 Electromagnetic Compatibility Statement

This equipment may generate and use radio frequency energy. The equipment must be installed and used
according to the manufacturer’s instructions in order to avoid radio frequency interference. If this
equipment generates or receives interference do the following to correct the problem:
• Verify that the equipment is the cause by turning the system on and off.
• In the event of unintended motor actuation, immediately remove power to the equipment.
• In the event of unintended X-Ray actuation, immediately remove power to the equipment.
• Reorient the equipment until the interference stops.
• Relocate the equipment with respect to other equipment in the room.
• Plug the equipment into a different outlet so that the equipment and the receiver are on different branch
circuits.
Use only input/output (I/O) cables supplied by GE HUALUN Medical Systems Co. Ltd.
This product conforms with IEC60601-1-2: 2007 Ed 3.0 and Ed 4.0 EMC standard for medical devices.

This equipment generates, uses, and can radiate radio frequency energy. The equipment
NOTE may cause or be subject to radio frequency interference with other medical and non–
medical devices and radio communications. There may RISKS of reciprocal interference
posed by ME EQUIPMENT during specific investigations and treatments. To provide
reasonable protection against such interference, the OEC One Mobile C-arm X-ray Product
system complies with emissions limits for a Group 1, Class A Medical Devices and has
applicable immunity level as stated in IEC60601-1-2.
However, there is no guarantee that interference will not occur in a particular installation.
The OEC One system needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided in the OEC One Operator Manual.

Use of RF (Radio Frequency) sources that intentionally transmit, such as cellular telephones,
transceivers, radio-controlled products, or other RF emitting equipment may cause
performance outside the systems published specifications or other adverse operation. Keep
the power to these RF sources turned off when near this equipment. Recommended
separation distances and information regarding compatibility with other equipment is
located in the " Guidance and manufacturers declaration-Electromagnetic Emissions " label
below:

If this equipment is found to cause interference (which may be determined by switching the
equipment on and off), the user (or qualified service personnel) should attempt to correct the
problem by one or more of the following measure(s):
1. Reorient or relocate the affected device(s).
2. Increase the separating space between the equipment and the affected device.
3. Power the equipment from a source different from that of the affected device.
4. Consult the point of purchase or service representative for further suggestions.

1-26
Introduction and Safety

Use of accessories, transducers, cables and other parts other than those specified by the
WARNING manufacturer of this equipment may result in increased emissions or decreased immunity of
the equipment. The manufacturer is not responsible for any interference caused either by the
use of interconnect cables other than those recommended, or unauthorized changes or
modifications to this equipment. Unauthorized changes or modifications could void the
operator’s authority to operate the equipment.
OEC One Mobile C-arm X-ray Product system should not be used adjacent to or stacked with
WARNING other equipment. If adjacent or stacked use is necessary, the OEC One system should be
observed to verify normal operation in the configuration in which it will be used.
To comply with the regulations applicable to an electromagnetic interface for a Group 1,
NOTE Class A Medical Device, and to minimize interference risks, the following requirements
should be applied:
1. The use of cables that are not properly shielded and grounded may result in the
equipment causing radio frequency interference in violation of the European Union
Medical Device directive and FCC regulations.
2. All of the recommended guidance regarding electromagnetic environment should be
followed.

Guidance and manufacturer’s declaration – Electromagnetic Emissions


The OEC One Mobile C-arm X-ray Product is intended for use in the specified electromagnetic environment. The
purchaser or operator of the OEC One Mobile C-arm X-ray Product should assure that it is used in an
electromagnetic environment as described below:
Emissions Test Compliance Electromagnetic Environment Guidance
Mains terminal The OEC One Mobile C-arm X-ray Product uses RF energy only
Group1 for its internal function. Therefore, its RF emissions are very low
disturbance voltage
CISPR 11 Class A and are not likely to cause any interference in nearby electronic
equipment.
Electromagnetic
radiation Group 1
disturbance Class A The OEC One Mobile C-arm X-ray Product is suitable for use in
CISPR 11 all establishments other than domestic and those directly
Harmonic emissions connected to the public low-voltage power supply network that
Not applicable
IEC 61000-3-2 supplies buildings used for domestic purposes.

Voltage fluctuations/
flicker emissions Not applicable
IEC 61000-3-3

1-27
OEC One Mobile C-arm X-ray Product

Guidance and manufacturer’s declaration - Electromagnetic Immunity


The OEC One Mobile C-arm X-ray Product is intended for use in the electromagnetic environment specified below.
The purchaser or operator of the OEC One Mobile C-arm X-ray Product should assure t31at it is used in an
electromagnetic environment as described below:
Immunity Test IEC 60601 Compliance Level Electromagnetic Environment
Guidance
Test Level
Electrostatic 8 kV contact 8 kV contact Floors are wood, concrete, or
discharge (ESD) ceramic tile, or floors are covered
15 kV air 15 kV air
IEC 61000-4-2 with synthetic material and the
relative humidity is at least 30 %.
2 kV for power supply 2 kV for power supply Main power quality is that of a
Electrical fast lines lines typical commercial and/or
transient Pulse hospital environment
1 kV for input/output
1 kV for input/output
IEC 61000-4-4 lines
lines
Surge 1 kV Line(s) to Line(s) 1kV Line(s) to Line(s) Main power quality is that of a
typical commercial and/or
IEC 61000-4-5 2 kV Line(s) to earth 2 kV Line(s) to earth
hospital environment.
Voltage dips, short Main power quality should be that
interruptions and of a typical commercial or hospital
voltage variations on environment. If the operator of the
power supply input 0% UT; 250/300 OEC One Mobile C-arm X-ray
lines cycle Product requires continued
0% UT; 250 cycle operation during power mains
IEC 61000-4-11
interruptions, it is recommended
that the OEC One Mobile C-arm X-
ray Product be powered from an
uninterruptible power supply or a
battery.
Power frequency 30 A/m 30 A/m.50 Hz Power frequency magnetic fields
magnetic field (50/ are at levels characteristic of a
60Hz) typical location in a typical
IEC 61000-4-8 commercial and/or hospital
environment.
NOTE:UT is the a.c. mains voltage prior to application of the test level.

1-28
Introduction and Safety

Guidance and manufacturer’s declaration - Electromagnetic Immunity


The OEC One Mobile C-Arm X-Ray Product is intended to use in the specified electromagnetic environment. The
purchaser or user of the OEC One Mobile C-Arm X-Ray Product should assure that it is used in an electromagnetic
environment as described below:
IEC 60601 Compliance Level Electromagnetic Environment
Test Level
Conducted RF 3 V rms, 6Vrms 3Vrms, 6Vrms at Portable and mobile RF communications
at ISM band ISM band 150GHz equipment are used no closer to any part of the
IEC 61000-4-6
150Hz to to 80MHz OEC One Mobile C-Arm X-Ray Product, including
80MHz cables, than the recommended separation
distance calculated from the equation
appropriate for the frequency of the transmitter.

3V/m 80MHz to Recommended separation distance


Radiated RF IEC 3V/m 80MHz to 2.5GHz (Ed3.0) 3.5
d = ------- P 150 kHz to 80 MHz
61000-4-3 2.5GHz(Ed3.0) 3
3.5 80 MHz to 800 MHz
3V/m 80MHz to d = ------- P
3
3V/m 80MHz to 2.7GHz, 28V/m 7 800 MHz to 2.5 GHz
2.7GHz,28V/m d = --- P
(Ed4.0) 3
(Ed4.0)
The formula are applicable for Ed3.0 only.
Note: P is the power rating of the transmitter in
watts (W) according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a,
are less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of
equipment marked with the following symbol:

1-29
OEC One Mobile C-arm X-ray Product

a: Field strengths from fixed transmitters, such as base stations for cellular telephones and land mobile radios, amateur radio,
AM and FM radio broadcast, and TV broadcast cannot be estimated accurately. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be performed. If the measured field strength exceeds the
RF compliance level above, observe the OEC One Mobile C-Arm X-Ray Product to verify normal operation in each use
location. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating
the [EQUIPMENT and/or SYSTEM].
b: Over the frequency range 150 kHz to 80 MHz, field strengths are less than 3 V/m.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
NOTE 3: These are guidelines. Actual conditions may vary.

1-30
Introduction and Safety

Guidance and manufacturer’s declaration - Electromagnetic Immunity


The OEC One Mobile C-arm X-ray Product is intended to use in the electromagnetic environment specified below. The
purchaser or operator of the OEC One Mobile C-arm X-ray Product should assure that it is used in an electromagnetic
environment as described below:

Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment

Test Maximum Immunity


Band a) Distance
frequency Service a) Modulation b) power test level
(MHz) (m)
(MHz) (W) (V/m)
Pulse
385 380 –390 TETRA 400 modulation b) 1.8 0.3 27
18 Hz
FM c)
GMRS 460,
450 430 – 470 5 kHz deviation 2 0.3 28
FRS 460
1 kHz sine
710 Pulse
LTE Band 13, modulation b)
745 704 – 787 0.2 0.3 9
17
780 217 Hz

810 GSM 800/900,


TETRA 800, Pulse
870 modulation b)
800 – 960 iDEN 820, 2 0.3 28
CDMA 850, 18 Hz
930
LTE Band 5
1 720 GSM 1800;
CDMA 1900; Pulse
1 845
1 700 – GSM 1900; modulation b) 2 0.3 28
1 990 DECT;
1 970 LTE Band 1, 3, 217 Hz
4, 25; UMTS
Bluetooth,
WLAN, Pulse
2 400 – modulation b)
2 450 802.11 b/g/n, 2 0.3 28
2 570
RFID 2450, LTE 217 Hz
Band 7
5 240 Pulse
5 100 – WLAN 802.11 modulation b)
5 500 0.2 0.3 9
5 800 a/n
5 785 217 Hz

NOTE: If necessary to achieve the IMMUNITY TEST LEVEL , the distance between the transmitting antenna and the

ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.

b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual
modulation, it would be worst case.

1-31
OEC One Mobile C-arm X-ray Product

The Recommended Separation Distances are listed in the next table.


It is applicable for Ed3.0 only.

Recommended Separation Distances for Portable and Mobile RF Communications Equipment and
the OEC One system
The OEC One Mobile C-arm X-ray Product is intended to use in the electromagnetic environment where the RF
interference is controlled. According to the power rating of the communication equipment, the purchaser or
operator of the OEC One Mobile C-arm X-ray Product can prevent the Electromagnetic interference by the
recommended separation distance as shown below:

Separation Distance/m

150KHz to 80 MHz 80 MHz to 800 MHz


Rated Power of
Transmitter/W
800 MHz to 2.5 GHz

3.5 3.5 7
d = ------- P d = ------- P d = --- P
3 3 3

0.01 0.12 0.12 0.23


0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a power not listed above, the Separation DISTANCE can be estimated using the equation
in the corresponding column, where P is the power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
NOTE 3: These are guidelines. Actual conditions may vary.

Use Recommendations
This product complies with IEC 60601-1-2 EMC standard for medical devices and with radio frequency
emission requirements as per CISPR11 Group1 Class B standard limits. The system is intended for use in
hospitals.
Adhering to the distance separation recommendation table, between 150 kHz and 2.5 GHz, will reduce
disturbances recorded at the image level but may not eliminate all disturbances.
However, when installed and operated as specified herein, the system will maintain its essential
Performance.
For example, a 1W mobile phone (800 MHz to 2.5 GHz carrier frequency) shall be put 2.3 meters apart from
the system (in order to avoid image interference risks).

1-32
Introduction and Safety

The use of accessories, transducers, and cables other than those specified may result in degraded
Electromagnetic Compatibility of the system.

1-33
OEC One Mobile C-arm X-ray Product

1.2.15 Lock-Out, Tag-Out


This procedure meets the basic LOTO requirements established by OSHA and follows the policy of GE
Healthcare for energy-isolation during the service/maintenance of this equipment. It is designed to insure
that each employee involved in servicing this equipment has exclusive control over when the equipment is
reenergized (i.e. each employee maintains a personal lock with a unique key).
It is the obligation of each employee to follow this procedure and understand that failing to do so can cause
serious injury or death.
Only Field Service Engineers who have complete LOTO Authorization and initial LOTO Verification training
will be permitted to execute Lock-out/Tag-out on this system. All other non-authorized individuals will be
considered “affected” individuals.
Specific Source of Energy

Type Source Magnitude Stored

Electrical Facility 120VAC/240VAC NO

Electrical Capacitors 310VDC YES

Electrical Inverter module (Connected with 310VDC YES


Capacitors)

Gravitational Potential (C-arm) ~22.69kg(~50 lbs) YES

Potential Energy Spring Arm 13.6-18kg(29.98-39.68lbs) YES

Energy Control Procedures


1. Notify all affected individuals of a shutdown.

2. Verify safety of work area.


3. Identify all electrical sources.
4. Position system for service.
5. Remove A/C plug from wall power.
6. Apply the red lock and tag to the AC plug.

1-34
Introduction and Safety

7. Open the front and rear covers.


8. Verify zero volts AC at breaker between the brown and blue wires.

9. Disconnect the cables. Release and remove the fixed screws, and then remove the DC power supply
assembly. Find the capacitor.

10. Measure the voltage value by the multimeter to verify that the voltage value is 0VDC.

11. Now, the power is now locked out.

1-35
OEC One Mobile C-arm X-ray Product

In the event service will continue into another day, the machine will cause a hazard if
NOTE reenergized after the authorized employee leaves the location.Therefore, the authorized
employee should install a “transition” lock and yellow tag attached to the A/C cord cover.
If more than the authorized employee is going to conduct service on the same system, at the
same time, multiple locking devices must be employed and each authorized employee must
adhere to the entire LOTO procedure.

Gravitational/mechanical energy
By removing the following components, unexpected gravitational energy can be released.
C A U T IO N
Removing the monoblock, image intensifier, or the C-arc can cause the rear of the system to
tilt and hit the floor. Place a wood block or equivalent under the rear of the system to prevent
tilting crush hazard.
Testing and Positioning during Service
In the event that lock-out/ tag-out devices must be temporarily removed from the energy isolating devices,
for testing or positioning purposes, the following sequence should be followed:
1. Clear the machine of tools and materials.

2. Ensure that all employees/individuals in area are safely positioned or removed.


3. Remove energy control measures.
4. Energize system and proceed with testing or positioning.
5. De-energize system and reapply energy control measure.
Restore Power after Service
1. Re-inspect work area for hazards.

2. Reinstall system covers.


3. Notify all affected personnel that power is being restored.
4. Remove red lock and tag.
5. Energize the system.
6. Verify proper system operation.
7. Inform all affected personnel that system is ready to be returned to service.
High voltage cables, electrolytic capacitors, can retain a dangerous static charge for a long
WARNING period after power has been removed. Some devices can acquire a charge spontaneously
without direct contact with other circuitry. Do not touch these components unless power
has been completely removed and they have been discharged. Equipment that contains
high powered electrical components must be serviced only by personnel familiar with
proper safety procedures for working near these components. Disconnect AC power before
discharging static electricity in components such as electrolytic capacitors and high voltage
cables. Failure to heed this message will result in death or severe personal injury.
Allow adequate time for static charges to discharge through bleeder resistors. Use a high
wattage resistor when discharging circuits to avoid burns. Have someone watch while you
work near high voltages. This person must remain clear of all circuitry and be prepared to
turn off the power to the system and render aid in an emergency.

1-36
Chapter 2 System Overview
OEC One Mobile C-arm X-ray Product

2.1 System Descriptions


The OEC One is a compact mobile fluoroscopic C-arm imaging system which physically consists of a mobile
stand with an articulating arm attached to it to support a 27 "image display monitor, a 10.1" TechView
tablet, a “C” shaped apparatus that has the X-ray Source assembly on the top of the C-Arm, and an image
intensifier at the opposite end.
The OEC One series products include two system serial number and two release versions software in
customer site.
The serial number BB6SS*******HL is indicated in the system rating plate and this series products’ software
release version is "Release version: 1".
The serial number BB6SV*******HL is indicated in the rating plate and this series products’ software release
version is "Release version: 2". These series products provide optional vascular imaging, dynamic recording
function and wireless footswitch, but it is not available for film mode.
The “*” in the system serial number is number which varies from 0-9 and represents manufacturing year and
number, there are 7 numbers in total.
To simplify the description, "Version 1" represents BB6SS*******HL series products and "Version 2" represents
BB6SV*******HL series products in this manual.
This service manual supports both series system for service, but some of the functions are available based
on which configuration the customer has purchased.

Only properly trained personnel can operate this equipment.


WARNING

OEC One Mobile C-arm X-ray Product includes:


• Mobile C-arm, X-ray generator, collimator, image intensifier and display device.
Options and Accessories:
‒ Printer
‒ Laser aimer on the tube
‒ Laser aimer on the image intensifier
‒ Skin spacer
‒ Video distributor
‒ Removable filter
‒ Removable grid
‒ Footswitch
‒ Software options
‒ Film cassette holder (It is not available in version 2.0 series system)
Nominal Length of External Cables:
‒ Power Cable: 7.5m
‒ Monitor Cable: 2.5m

2-2
System Overview

‒ C-arm Cable: 2.4m


‒ Hand Switch Cable:0.8m
‒ Footswitch Cable (option): 5m or 10m
‒ Printer Cable (option): 2.5m

2-3
OEC One Mobile C-arm X-ray Product

2.2 System Components Overview


1. Image Intensifier & Camera 21. C-arm Handle
2. Grid 22. Front Universal Wheel
3. Monoblock Handle 23. Rear Steering Wheel
4. Monoblock & Collimator 24. Spring Arm Lock
5. Exposure Indicator 25. Spring Arm
6. Monitor 26. TechView Tablet (Control Panel)
7. Monitor Handle 27. Extension Arm
8. Extension Arm Handle 28. Extension Arm Brake Handle
9. Cross Arm Brake Handle 29. Wig-wag Brake Handle
10. Lateral Brake Handle 30. Driving Handle
11. Emergency Switch 31. Steering Handle
12. UP/Down Button 32. Power On/Off Button
13. Orbital Brake Handle 33. Power Cord & Footswitch Holder
14. Brake Pedal 34. Hand Switch & Holder
15. Key Switch 35. NTSC/PAL Composite Video Output Connector
16. Power Indicator 36. DVI-D Digital Video Output
17. Power Cord 37. Ethernet Port
18. Incoming Circuit Breaker 38. Room Interface
19. Footswitch Socket 39. USB Port
20. Image Intensifier Handle 40. Wireless Power Switch

2-4
System Overview

2-5
OEC One Mobile C-arm X-ray Product

2-6
Chapter 3 Installation
OEC One Mobile C-arm X-ray Product

3.1 Overview
This chapter describes the installation procedure of OEC One C-arm system.

3.2 Pre-Installation
3.2.1 Dimensions and Weights of System

Packing Dimensions:
H  W  L=200cm  91cm  204cm (78.7"  35.8"  80.3")

Packing Weight:
491±10kg

System Dimensions:
Hmax/Hmin  W  L=216/172cm  78cm  179cm (85"/76.7"  30.7"  70.3")

System Weight:
310kg

3.2.2 Site Requirement

Scan room (H  W  L): ≥ 2.8 m  5.5 m  5.0 m

Scan room door (H  W): ≥2.0 m  1.2 m

Aisle (W) : ≥2m

  Enough room should be provided for the movement, installation and operation of the
WARNING system.

  The floor should be hard, smooth and level enough to support the system.
WARNING

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Installation

3.2.3 Power Supply Requirement

Voltage: AC 100V/110V/120V/200V/220V/230V/240V ±10%


Frequency: 50Hz/60Hz
Rated Momentary Line Current (shorter than 5s):
• 30A (100V/110V/120V)
• 28A (200V)
• 25A (220V/230V/240V)
Rated Continuous Line Current:
• 20A (100V/110V/120V)
• 12A (200V)
• 10A (220V/230V/240V)
Maximum Line Impedance:
• 0.3Ω (AC 100V/110V/120V)
• 0.6Ω (AC 200V/220V240V)

Suitable sockets are required both in scan room and operating room for maintenance.
NOTE Power supply should comply with requirements of the system power supply.The sockets
should be 3 cores with protective earth, which complies with the requirement of the
applicable electrical codes. Other equipment electrically connected with this apparatus
shares the same grounding connection.

  You should check the local power supply first. If it is not 200 V/220 V/230 V/240 V (50 Hz),
WARNING you need to change the power supply cables and change the connections of the system.
Refer to the power supply adaptation Section3.6.1 for details.

3.2.4 Environments

Operating Conditions:
Temperature: +10°C~+40°C (+50F~+104F)
Humidity: 20%~80% Relative, non-condensing
Atmospheric Pressure: 700hPa~1060hPa
Transportation and Storage:
Temperature: -20°C~+55°C (-4F~+131F)
Humidity: 10%~95% Relative, non-condensing
Atmospheric Pressure: 500hPa~1060hPa

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OEC One Mobile C-arm X-ray Product

3.2.5 Tools and Test Equipment


Standard tools and test equipment are required to install the system. In addition to standard this, the
following special tools and equipment are required to complete this procedure.

Tool and Equipment List


Item Standard Tool and Equipment Comments
Recommend to use auto screw driver
1 Screw Drivers
with Philips 2 head.
Monkey wrench or wrench for M8 and
2 Wrench
M12 hexagon screw
3 Allen Keys
4 Dosimeter
10"×12" Film (It is not available in version 2
5
series system.)
6 Spatial Resolution Tool
7 Lead apron (thicker than 3mm)
8 Scissors or Substitute
9 Stopwatch
10 Network Cables
11 Tape Measure
12 Multimeter or Equivalent
13 USB Keyboard
Item GE Tool GE part number
9" Film Cassette Holder (It is not available in
1 5085005
version 2 series system.)
2 3 Copper Sheets, each 1mm thick 00-877682-01

9" Beam Alignment Tool Assembly or 00-878105-02 or


3
UBAT(Universal Beam Alignment Template) 5307604
4 Service tool USB-DVD Rom 5075511

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Installation

3.3 Unpacking
Before unpacking, inspect the shipping enclosure /boxes for damage and report to the
NOTE shipper if available.

The unpacking of the system should be done before moving it into the operation room, in order to check if
there is damage that occurred during transportation.
The packages should be examined minutely during installation to identify missing parts with small
dimensions, or envelopes containing screws, washers, etc. Once damage or shortage are observed, notify
service of the transportation and insurance company immediately.
If non-apparent damage due to transportation is found during unpacking or installation, take the same
action within 15 days after receipt. The transportation corporation will not generally pay for non-apparent
damage unless an application for inspection is made within 15 days after receipt.
If damage is discovered, contact the related company immediately, specifying the type of apparatus, the
serial number and the order number if possible, and describing the nature of the damage.
Please follow the steps below to unpack the OEC C-arm.

3.3.1 Shipping Container Inspection

Inspect the shipping container for signs of visible damage. If damage is seen make note of the damage on
the install checklist.

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OEC One Mobile C-arm X-ray Product

3.3.2 Unpacking System


1. Place the package on a flat surface and leave enough space to be able to work around the system.
2. Cut off the binding ties. Remove the cardboard box.

During unpacking,take care to avoid damage on machine and keep protective films of the
NOTE machine until delivered to the customer.

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Installation

3. Remove the seal wrappers.Put the ramp in position.

4. Remove all wrappers and get accessory boxes.

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OEC One Mobile C-arm X-ray Product

5. Remove fixed screws and the wood support boards.

6. Remove the screws from the frame of the monoblock and remove the wood board.

7. Remove the fixed screws of the front bracket left and right sides. ( 13# Socket tool)

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Installation

8. Remove the fixed screws as pictured below.

9. Find the wood crowbar from package. Lift the system as pictured below to remove both side wood
supports..

Underside

Upside

Do not pry the system cover of the mainframe.


NOTE Make sure that put the wood crowbar in a downward direction that the dip angle face down.

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OEC One Mobile C-arm X-ray Product

10. Remove the four fixed screws as shown below (13# Socket tool).

11. Remove the metal bracket from the base.

12. Lock the brake pedal. Then use the wood crowbar and rear wood support to pry the front base of
system and remove the wood support as shown below.

The wood crowbar should be used as shown above. Pay attention to mainframe base cover.
NOTE

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Installation

13. Remove screws under metal bracket. Remove the metal bracket from front base.

14. Cut off the binding tie and remove the protective materials.

15. Remove the screws and wood board as shown below.

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OEC One Mobile C-arm X-ray Product

16. Move the monitor extension arm out of the wood support. Remove the wood support.

17. Remove the fixed screws as pictured below both sides. (15# screws)

18. Lift the monitor and remove the mental support.

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Installation

19. Position the monitor to the extension arm handle and lock the spring arm as shown below.

20. Make sure release the lateral and orbital brake handle, and release the brake pedal. Move the C-arm
system backward to draw out monoblock and I.I from the wood limitation frame slowly. Then position
the C-arm to normal place and lock both brake handles.

Take care to protect the image intensifier and grid when moving the C-arm system.
NOTE

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OEC One Mobile C-arm X-ray Product

21. Make sure all brakes are locked except the brake pedal. Turn the right steering handle in a home
position to keep the rear wheels in a straight direction. Then move the system backward carefully along
the ramp to the site you desire.

22. Remove the wrapper that is covering the system if needed.


23. Release the horizontal cross-arm lock handle. Loosen the limit device with a screwdriver or wrench.
The limit device is easily removed after powering on system and lifting the lift column.

24. Remove package of emergency switch. Release emergency switch.

25. Check parts according to the packing list with the system for details.

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Installation

3.4 Transport the System


Be familiar with the location and mechanical operation of all controls before transporting the system.

Neglecting the precautions during movement could cause loss of control of the system and
C A U T IO N
cause injury to the operator and to others.

Before moving the system, please make sure it is in transportation position. Otherwise,
WARNING equipment damage or personal injury may result.

Pay attention and keep your feet clear of the chassis whenever moving the system.
C A U T IO N

Cords and cables connected to the system can become trip and/or snag hazards in the
C A U T IO N
working area. Personnel working near the system should be aware of all cords and cables
whenever they move around the system or the system is moved.

NOTE The battery should be disconnected before transporting the system.

Be aware:
• Check and make sure there are no obstacles in the way.
• Move the system slowly.

1. Press and hold the power on/off button 2 seconds to switch the system off if it is powered on.
2. Unplug the power supply cable from power source and secure the cable around the appropriate
hanger.

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OEC One Mobile C-arm X-ray Product

3. Lock the monitor assembly to the latch of the monitor arm (transport position), as pictured below.

When the system is positioned on an incline with the brake handle released, the C-arm might
WARNING be unstable. Please be sure to put the system in lock position.

4. Coil and secure the footswitch cable around the footswitch socket.
5. Unlock the wheel brakes on the system.
6. Guide the system to its destination using the system handles.

Do not move the C-arm over inclines greater than 10°. Do not move the C-arm on stairs. Do
WARNING not lock the C-arm in place on an incline greater than 5°.
Transport the system at normal speed. Get across ramps and thresholds as slow as possible.

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Installation

7. When reaching the destination, place the C-arm’s brake pedal in the locked position.
8. Check whether the cable pushers have been installed. If not, please install them.

9. According to customer requirements to remove plastic protective films when finish all service action.

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OEC One Mobile C-arm X-ray Product

3.5 System Inspection


3.5.1 Label Inspection
After the system installation, check that all labels shown below are in position.The labels position please
refer to Section 1.2.11 Labels and Section 1.2.12 Locations of the Labels.

Following system labels should be in local language according to the regulation


NOTE requirement.

Actual content refers to the labels on the system.


NOTE

System Labels

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Installation

Option Labels

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OEC One Mobile C-arm X-ray Product

3.5.2 External Inspection


1. Cabling and Connector Inspection.

Anti-Static Drag Wire Check the system’s anti-static drag wire. It is suspended below the
system. The wire must be securely attached to the system and not
encumbered by debris.
Monitor Cable and
Check monitor cable and bundle cable for damage or other problems.
Bundle Cable
AC Power Cord and Plug Verify that the AC power cord and plug supplied with the system are the
correct ones for customer facility.

2. C-arm Inspection
Inspect each C-arm component listed under the heading C-arm Inspection. Select one box to select for each
item in the list. The choices are:
• No Problem Found
• Loose or Missing Parts
• Broken or Damaged Parts
• Chipped or Scratched Paint

The items to inspect are grouped according to the larger visible, easily accessible assemblies and/or
modular parts of the system. Each inspection of an assembly item should include its visible component
parts and sub-assemblies.

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Installation

C-arm Inspection List

No Problem Loose or Missing Broken or Chipped or


Physical Location
Found Parts Damaged Parts Scratched Paint

Image Intensifier

C-arc

Monoblock

Control Panel

Handles

Wheels

Monitor and Arm

Covers

Frame

3.5.3 Internal Inspection


1. Internal Inspection must be based on electrostatic discharge safety procedures.
WARNING
2. Remove any covers that expose dangerous voltages. When possible, disconnect the
system with AC line before removing these covers. When the inspection must be
implemented with the power on. Use extreme care to avoid death or injury from electrical
shock.

Refer to Replacement section to remove rear cover, and check if the battery cable is well connected.
Refer to Replacement section to remove front cover, inspect if any computer cables are loose.

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OEC One Mobile C-arm X-ray Product

3.5.4 Battery Pack Check


Considering unstable conditions of shipping, the battery is not connected with the system.
Follow these steps to insure the connection of the cable to the UPS battery:
1. Check and release the emergency switch.

2. Check if the battery cable is well connected.

1. The battery should be recharged if necessary.


CAUTION 2. The battery should be disconnected from system before shipping.

There are two means to disconnect the UPS battery from system before shipping:
NOTE 1. Press the emergency switch and lock it by fixed tool. (When shipped by factory)
2. Disconnect the cable of battery pack. (When no emergency switch lock)

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Installation

3.6 System Setup


3.6.1 Power Supply Adaption

Follow steps below to change power supply:


1. Remove the rear and front covers if needed.
2. Depress breaker button if jump up and release emergency switch if pressed.
Breaker

3. Remove three fix screws of PMU board former, and put down PMU board former. Find the input voltage
setting jumper on J2 or J3. Ensure the jumper installed to J3 for 100/110/115/120 VAC, or installed to
J2 for 200/220/230/240VAC.

220V Jumper-J2

110V Jumper-J3

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OEC One Mobile C-arm X-ray Product

4. Check the bridge in your system as picture below. Change the bridge connectors of the transformer if
needed.

200/220/220/230/240V AC 100/110/120V AC

5. Before installing the system, please check the power supply voltage range and the transformer
connection according to the diagram below. The system can adapt power supply of AC100V, AC110V,
AC115V, AC120V, AC200V, AC220V, AC230V and AC240V by different connections of the transformer.

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Installation

Cable(6888719) Wiring terminal J1 label number

Voltage 100 V 110V/115 V 120 V 200V 220V 230V 240V


11-12 11-12 11-12
Jumper 12-13 12-13 12-13 12-13
13-14 13-14 13-14
J1-9R
8 9 10 8 9 10 10
(Red)
J1-6R
5 6 7 5 6 6 7
(Blue)
220VJ1-4R
110VJ1-2R 2 2 2 4 4 4 4
(Black)
220VJ1-3R
110VJ1-1R 1 1 1 3 3 3 3
(Brown)

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OEC One Mobile C-arm X-ray Product

3.6.2 Power On/Off

Perform the following steps to turn the system on


When you place a recently unpacked system into use, allow it to stand in its new
C A U T IO N
environment long enough for any condensed moisture to evaporate. A decrease in
temperature or a humidity increase can cause water vapor in the air to condense, sometimes
on electric circuits.You may damage the equipment if you apply power before this
condensation dries.

1. Take out footswitch from the accessory package. Connect the footswitch to system.
Before powering on the system, user shall re-check and make sure that the voltage of the
WARNING wall power is in the correct range. Otherwise you can’t power on the system.

2. Plug the power cord into appropriate AC receptacle, and make sure the power indicator is lit up. Press
and hold the power on/off button 1 second (refer to the operator manual). The power on/off indicator
should keep remain lit.

Power On/Off Button

3. Verify that the system complete software boot has completed and initialized with no errors reported
on their displays.
4. The field size is in normal state by default. The auto fluoroscopy mode is selected.
5. The system is ready for operation when the login screen or exam management screen is displayed on
the monitor. The boot up time is about 2 minutes.
Perform the following steps to turn the system off
1. Press and hold the power switch, then the power button light will start flashing and the system will turn
off.
If pressing the power switch fails to turn the system off, unplug the power cord, and wait for
NOTE the system to execute the shutdown process.

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Installation

2. After turn off the system, the power button light will be turned off. Then unplug the system power cord
from the AC receptacle.
After turning off the system, please wait for at least 1 minute before powering the system
C A U T IO N
back on. This can help to prevent operational problems.
Turn off all power to the system before moving it, or if a problem occurs which prevents
NOTE normal operation.
All power should also be turned off when periodic maintenance and cleaning is performed.
During shut down, the power should not be cut off automatically until the system software
is logged off.
While the system is being shut down, it will ignore commands from pressing power switch
button until shutdown is finished.
Do not use emergency switch when the system is in normal use, it is just used in emergency
C A U T IO N
case such as in a fire. It will cut power immediately which may cause data to be lost. Use this
switch with caution. If pressing this switch to power off, operator needs to unplug and plug
the AC plug before powering on the system next time.

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OEC One Mobile C-arm X-ray Product

3.6.3 Facility Leakage Current and Ground Continuity Test Notification

The medical facility may require to perform current leakage and grounding continuity tests on the system
before it is put into service. In that case, the leakage current and ground continuity tests should be
performed as required.
Refer to section Ground Continuity in Chapter Periodic Maintenance to do ground continuity tests.
Notify the service personnel to follow local regulation and following waring:

Ground continuity tests shall be conducted before undertaking any leakage current test.
WARNING

Power must be off on the system before and during any tests. Do not interrupt power to the
WARNING system at any time while the system is booting or shutting down to avoid file system
corruption.

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Installation

3.6.4 System Configuration in Administration


Setup in Admin Interface by Service Authority
1. After OEC One system has booted up successfully, enter Admin mode:
By "Setup screen" -> "Maintenance" -> "Login Administration". Click the "Yes" button to access Admin
login screen. Select "Service" as user by clicking drop down list button, input service authority
password. Click the "Login" button, access Administration screen.
a). For version 1 series system, by "Setup screen" -> "Maintenance" -> "Login Administration". Click the
"Yes" button to access Admin login screen. Select "Service" as user by clicking drop down list button,
input service authority password. Click the "Login" button, access Administration screen.
b). For version 2 series system, after the GE Service Access Key (GESAK) USB stick is plugged in, a
confirm message will be displayed on the monitor, then click “Yes” button to access Administration
screen. For the detailed information about GE Service Access Key (GESAK), refer to Section 5.1.
2. Click “System Information”, then input the system ID (For version 2 series system, need proprietary level
GESAK tool to edit the system ID).

About system ID set or upgrade


The system ID will be set to blank during manufacturing. Field engineer shall set system ID during
installation and make sure it’s the same as the SID in service record system.
Field engineer can set or change system ID. Current system ID is displayed on the screen automatically. Fill
the new system ID in the textbox and restart system.

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OEC One Mobile C-arm X-ray Product

Changing system ID needs to contact GE service engineer.


NOTE

3. Click “Product Config” tab. Then activate software option feature by inputting e-License key.

Activate software option feature by typing


Input option name into Area_1 and input option license key into Area_2. Click the “Add” button in software
option area.
Activate software option feature from USB disk
Insert USB disk with license file into USB port, click drop down list button of “Medium” to select
corresponding sub-area and license file, click the “OK” button.
Hardware Configure
Filter Option: Disable/Enable removable filter option.
Software Options List:
• Annotation
• Measurement

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Installation

• Basic DICOM
• Q&R
• MPPS
• Option Cine 8 (not available in version 1 series system)
• Option Cine 12 (not available in version 1 series system)
• Option Cine 25 (not available in version 1 series system)
• Option DSA Roadmap (not available in version 1 series system)
4. Select the “Exposure Config” button. Check exposure control, dose group setting, dosimeter unit setting
and high level exposure setting on “Exposure Config” screen. If any data is changed or reset, system
needs to be rebooted system to active it.

Select “Exposure Config” tab on the main screen. “Exposure Config” screen will be displayed.

Restore Default
Restore Default can restore all settings back to the default value.
Once the "Restore Default " button is clicked, the instructions below must be followed to
NOTE recheck and set all of the items in “Exposure Config”.

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OEC One Mobile C-arm X-ray Product

Exposure Control
Enable or disable “Auto Termination at 9'30" in one shot” function. If this function is enabled, when the
continuous fluoroscopy time reaches 9'30", X-rays will be terminated automatically.
Select “Film” option to enable or disable film exposure mode.(It is not available in version 2 series
system)

Refer to the “Exposure Management Matrix” table at the end of this section to set fluoro alarm
NOTE controls.

The system must be rebooted before the terminate short exposure function can be enabled.
NOTE

Dose Group Setting


Based on the real power input select corresponding input voltage setting.

After reloading system software, input voltage needs be set up and checked. Wrong input
NOTE
voltage settings will lead to system working in abnormal mode.

The following section describes the instructions on how to set dose group and X-ray controls
NOTE according to the following table “Exposure Management Matrix”. If the instruction contradicts
the corresponding regulatory requirements of certain countries or regions
(according to the example, some regulatory requirements are updated), change the setting of
regulatory requirements.

After reloading system software, the dose group needs to be set up and checked.
NOTE

Select “Dose Group Option” by country to set the dose limitation in normal (standard) and HLF exposure. The
available options are:
- Normal 88 and HLF 100
- Normal 50 and HLF 50
- Normal 50 and HLF 100
The skin dose rate in the dose group represents the value for conditions of free-in-air irradiation on the
patient’s skin: 30cm along the beam axis from the image intensifier surface.
1. Two dose groups in normal (standard) fluoro mode:
- Normal 50: The skin dose rate does not exceed 50mGy/min in standard fluoro mode, such as
Australia, Japan, New Zealand, etc.
- Normal 88: The skin dose rate does not exceed 88mGy/min in standard fluoro mode, such as USA,
Germany, etc.
2. Two dose groups in HLF mode:
- HLF 50: The skin dose rate does not exceed 50mGy/min in HLF mode, such as Japan, etc.
- HLF 100: The skin dose rate does not exceed 100mGy/min in HLF mode, such as Australia, Italy, UK,
New Zealand, etc.

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Installation

For the countries, such as USA, if the skin dose rate does not exceed 176mGy/min in HLF mode from its
regulatory requirements, the system will use HLF 100 in HLF mode because the maximum skin dose rate of
the X-ray tube cannot exceed 100mGy/min.
3. For some countries, their dose limitation should be the combination of the above normal and HLF
groups. For example:
- Australia: Normal 50 and HLF 100
- China: Normal 88 and HLF 100
4. For countries or regions that have a higher standard fluoro dose (on the patient’s skin) rate limit than
USA, the dose limits are set to the same value as USA.
5. For countries or regions that have a higher HLF dose (on the patient’s skin) rate limit than USA, the dose
limits are set to the same value as USA.
6. For countries or regions that do not specify standard fluoro dose on patient’s skin, the dose limits are
set to the same value as USA.
7. For countries or regions that do not specify HLF dose on patient’s skin, the dose limits are set to the
same value as USA.
Refer to the below table “Exposure Management Matrix” to set dose group.
Dosimeter Unit Setting
Field engineer can configure software dosimeter unit in this interface.
HLF Level Exposure Setting
Disable after high level exposure: Enable or disable “The system automatically Disable After High Level
Exposure” function. Some countries or regions, such as certain provincial locations in Australia, may require
enabling it.
Disable after no exposure for 5 minutes: Enable or disable “Disable after No Exposure for 5 Minutes”
function. Some countries or regions, such as certain provincial locations in Australia, may require enabling
it.
HLF accessible only in auto ABS: Enable or disable “HLF Accessible Only in Auto ABS” function. Some
countries or regions, such as certain provincial locations in Australia, may require enabling it.
Automatic termination at 20" in one shot:
Enable or disable “Automatic Termination at 20" in One Shot” function. Some countries or regions, such as
Australia or Switzerland, may require enabling it. For other countries, disabling “Automatic Termination at
20" in One Shot” is preferred in the system installed with DSA/Roadmap option.
Refer to the following table “Exposure Management Matrix” to set HLF scene setting.
Reboot the system for enabling a new setup.
NOTE

Exposure Management Matrix

Disable
Auto Disable HLF Automatic
after No
Countries / Termination Terminate after High Accessible Termination
Dose Group Exposure
Regions when exposure Short Level Only in at 20” in One
for 5
exceeds 9’30" Exposure Exposure Auto ABS Shot
Minutes
Albania In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

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OEC One Mobile C-arm X-ray Product

Disable
Auto Disable HLF Automatic
after No
Countries / Termination Terminate after High Accessible Termination
Dose Group Exposure
Regions when exposure Short Level Only in at 20” in One
for 5
exceeds 9’30" Exposure Exposure Auto ABS Shot
Minutes
Algeria In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Angola In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Argentina In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Australia In one exam Enable Normal 50 and HLF 100 Enable Enable Enable Enable
Austria In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Bahrain In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Bangladesh In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Belarus In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Belgium In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Bolivia In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Bosnia In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Brazil In one exam Enable Normal 50 and HLF 100 Disable Disable Disable Enable

Brunei In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Burkina Faso In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Cambodia In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Cameroon In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Chile In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

China (P.R.) In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Colombia In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Costa Rica In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Cote d'lvoire In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Croatia In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Cyprus In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Czech
In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Republic
Denmark In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Egypt In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

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Installation

Disable
Auto Disable HLF Automatic
after No
Countries / Termination Terminate after High Accessible Termination
Dose Group Exposure
Regions when exposure Short Level Only in at 20” in One
for 5
exceeds 9’30" Exposure Exposure Auto ABS Shot
Minutes
France In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Germany In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Greece In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Guatemala In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Honduras In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Hong Kong In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Hungary In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

India In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Indonesia In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Iraq In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Ireland In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Israel In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Italy In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Jamaica In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Japan In one shot Enable Normal 50 and HLF 50 Disable Disable Disable Enable

Jordan In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Kazakhstan In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Kuwait In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Laos In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Lebanon In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Libya In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Luxembourg In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Macedonia In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Malaysia In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Malta In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Mexico In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

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Disable
Auto Disable HLF Automatic
after No
Countries / Termination Terminate after High Accessible Termination
Dose Group Exposure
Regions when exposure Short Level Only in at 20” in One
for 5
exceeds 9’30" Exposure Exposure Auto ABS Shot
Minutes
Montenegro In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Morocco In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
New
In one exam Enable Normal 50 and HLF 100 Disable Disable Disable Enable
Zealand
Netherlands In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Nigeria In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Oman In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Pakistan In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Panama In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Paraguay In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Peru In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Philippines In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Poland In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Portugal In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Romania In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Russia In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Qatar In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Saudi Arabia In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Serbia In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Singapore In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Slovakia In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

South Africa In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

South Korea In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Spain In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Switzerland In one shot Enable Normal88 and HLF 100 Disable Disable Disable Enable

Taiwan In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Thailand In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

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Installation

Disable
Auto Disable HLF Automatic
after No
Countries / Termination Terminate after High Accessible Termination
Dose Group Exposure
Regions when exposure Short Level Only in at 20” in One
for 5
exceeds 9’30" Exposure Exposure Auto ABS Shot
Minutes
Trinidad &
In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Tobago
Tunisia In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Turkey In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

Ukraine In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
United Arab
In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Emirates
United
In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
States
United
In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Kingdom
Uruguay In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Venezuela In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable
Vietnam In one shot Enable Normal 88 and HLF 100 Disable Disable Disable Enable

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3.6.5 System Configuration in User Setup Interface

1. Press the “Setup” button on the


monitor to access the setup screen.

2. Select “Date Time & Region” tab to setup:


• Date
• Time
• Time Zone
• Language
• Date Format
• Time Format
• Number Format
• Weight Unit
• Height Unit

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3. Select “C-arm System” tab to setup:


The user interface as pictured below is for complete version 01.02-01 system.

• Hospital Name
• Retain Last Exam Change or Boot Up
• Exam List Display
• B/C Preference
• Screen Saver
• Beep after Saving Image Successfully
• Auto Save at End of Exposure
• Auto Swap
• Room Interface
• Exposure Sound
• Dose Warning Threshold
• Terminate Short Exposure When

The user interface as pictured below is for complete version 01.03-01 system and later.

• Hospital Name
• Retain Last at Exam Change or Boot Up
• Exam List Display
• B/C Preference
• Screen Saver
• Beep after Saving Image Successfully
• Auto Save at End of Exposure
• Auto Swap
• Display Marker
• Room Interface

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4. Select “Exposure Config” tab to set up:


The user interface shown as the picture below is only for complete version 01.03-01 system and later.

• Default Settings at Exam Change or Boot Up


• Mode Pair
• Exposure Sound
• Dose Warning Threshold
• Terminate Short Exposure When

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3.6.6 DICOM Setup and Check


You can choose the verification items from DICOM worklist server, storage server and printer
NOTE server, according to the customer’s network situation and equipment.

Available DICOM features are displayed in product config/software option list, in this section
NOTE just setup and check the options purchased by customer for this section:
Option Basic DICOM (Contains: DICOM Worklist/DICOM Storage & Commitment/DICOM
Print), Option DICOM Q&R, Option DICOM Mpps.
1. Plug the network cable into the network connector socket.

2. Press the “Setup” button in application interface to invoke the setup interface.

3. Network & DICOM setup


Click “Network & DICOM” tab to
• Local AE Title
The default AE Title is “GEHC OEC”. You can
change it according to the DICOM
service’s requirement.
• Station Name
• Local Network

Click “Configure…” button and fill in the


network information.
Refer to Section 3.8 to perform Wireless
network setup and vey.
• Target IP
Input “Target IP” then click the “Ping”
button to verify that the network
configuration is successful or not.

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4. Worklist Server Setup and Check (Optional)


Worklist Setup
• Select the “Worklist” button in the
setup interface.
• Click the “Add…” button and fill in the
information of the DICOM worklist
server.
• Click the “Edit…” button, edit the
information of the existing DICOM
worklist server.
• In “Add…” and “Edit…” interface, click
“Verify” button. The message “The
DICOM server has verified
successfully.” will display if the
server has connected. Click the
“OK” button, then select the “Exit”
button to close the worklist
screen.
• Use the “Delete” button to delete
existing worklist server.

Worklist Check

• Click the “Exam Management”


button to enter exam management
screen.
• Click the “Schedule…” button to enter
schedule exam screen.
• On “Scheduled Exams” screen, check
the radio button of worklist server
and select target server, click the
“Quick Query” button then patient list
in worklist server will be displayed if
all configurations and parameters
are correct.

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5. DICOM Printers Setup and Check (Option)


DICOM Printers Setup
• Click “DICOM printers” tab on setup
screen.
• Click the “Add…” button into Add
interface. Fill in the information of the
DICOM printers.
• Click the “Edit…” button into Edit
interface, edit the information of the
existing DICOM printers.
• In add and edit interface, click the
“Verify” button. The message “The
DICOM server has been verified
successfully.” will display if the server
has been connected. Click the “OK”
button, then select the “Exit” button
to close DICOM printer interface.
• Use the “Delete” button to delete
existing DICOM printer.

DICOM Printers Check

• Click the “Image Directory” button in the


setup interface.
• Select the available printer in the DICOM
printer drop down list. Click the preview
image first and then click the image box/
boxes. Click the “Print” button. Verify that
the images can be printed successfully
after the process completes.

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6. Storage & Commitment Servers Setup


and Check (Optional)
Storage & Commitment Servers Setup
• Click “Storage & Commitment Servers”
button in setup interface.
• Click the “Add…” button into add screen.
Fill in the information of the DICOM
storage and commitment server.
• Click the “Edit…” button into edit screen.
Edit the information of the existing
DICOM storage and commitment
server.
• On add and edit screen, click the “Verify”
button. The message “The DICOM
server has verified successfully.” will
display if the server has connected.
Click the “OK” button, then select the
“Exit” button to close the DICOM
storage server list screen.
• Use “Delete” button to delete existing
DICOM storage and commitment
server.
Storage & Commitment Servers Check

• Click the “Image Directory” button.


• Select "Storage” tab.
• In Send To pull down list, select one of
available select the DICOM storage
devices.
• Select one or more preview images you
want to archive by choosing the
check box in the directory. Click the
“Send” button.
• Verify that the images are sent to the
storage server successfully after the
copy progress completes.
• If the “Enable Storage Commitment” box
is checked in “Setup” interface, the
symbol “S” displayed on the preview
image means the image is
successfully sent to the DICOM
storage and commitment servers.

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7. Query & Retrieve Setup and Check (Optional)


Query & Retrieve Setup
• Click the “Query & Retrieve” tab in the setup
interface.
• In “Local Settings”, setup the following:
•Local Listening Port
•Time Out
•Days to Cache Retrieved Images
• Click the “Add…” button to move into add
interface. Fill in the serve information.
• Click the “Edit…” button into edit interface,
edit the server information.
• In add and edit interface, click the “Verify”
button. The message “The DICOM server
has verified successfully.” will display if
the server has connected. Click the “OK”
button and then select the “Exit” button
to close add or edit interface.

Query & Retrieve Check

• Click the “Query and Retrieve”


button to enter “Query & Retrieve”
screen.
• Select target server and input filter
option for query, then click
"Query" button. The target patient
data will be displayed in Query
Results.
• Select target patient data in query
results, then click “Retrieve”
button. The target patient data
will be displayed in Retrieved
Results.

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8. MPPS Servers Setup and Check (Optional)


MPPS Servers Setup
• Click “MPPS Servers” tab on the monitor.
• Click “Add…” button to move into add
interface. Fill in the information of the
MPPS servers.
• Click the “Edit…” button to move into edit
interface, edit the information of the
MPPS servers.
• In add and edit interface, click “Verify”
button. The message “The DICOM server
has verified successfully.” will display if
the server was connected. Click the “OK”
button, then select the “Exit” button to
close add or edit interface.
• Use “Delete” button to delete existing MPPS
servers.

MPPS Severs Check


Create a new exam, take an exposure
and save several images.
In Image Directory

Exam Status: In progressing


MPPS Status: Unreport

Click Report MPPS button  

Exam Status: In progressing


MPPS Status: Report

Click Complete button  

Exam Status: Complete


MPPS Status: Unreport

Click Report MPPS button  

Exam Status: Complete


MPPS Status: Reported

Then in MPPS server complete information about the exam will be available.

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3.6.7 DICOM Worksheet


Record Network & DICOM information below
Station Name:

Enter information into “Network & DICOM” screen.


AE Title:
Enter information into “Network & DICOM” screen.

Local Network: Wireless Network:


Does this site use DHCP? Does this site use DHCP?

Yes No Yes No

IP Address: IP Address:
Enter information into “Network & DICOM” screen. Enter information into “Network & DICOM” screen.
Gateway: Gateway:
Enter information into “Network & DICOM” screen. Enter information into “Network & DICOM” screen.
Subnet Mask: Subnet Mask:
Enter information into “Network & DICOM” screen. Enter information into “Network & DICOM” screen.

Will the site use DICOM Printer Server? Yes No


If yes, record their configuration here.

Server Alias:

AE Title:

IP Address: Time out:

Port Number: Maximum Density:

Minimum Density:

Config Info.:

Border Density: BLACK WHITE Orientation: PORTRAIT LANDSCAPE

Empty Density: BLACK WHITE Film Size: 8IN×10IN 10IN×12IN

10IN×14IN 11IN×14IN

Copies: 1 2 3 4 5 6 7 8 9 10
Print Priority: HIGH MEDIUM LOW
Destination: MAGAZINE PROCESSOR
Medium Type: PAPER CLEAR FIL BLUE FILM
Layout 1: 1×1 1×2 2×1 2×2 2×3 3×3 3×4 4×4 4×5 5×4

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Layout 2 1×1 1×2 2×1 2×2 2×3 3×3 3×4 4×4 4×5 5×4

Layout 3: 1×1 1×2 2×1 2×2 2×3 3×3 3×4 4×4 4×5 5×4

Layout 4 1×1 1×2 2×1 2×2 2×3 3×3 3×4 4×4 4×5 5×4

Will the site use DICOM Printer Server? Yes No

If yes, record their configuration here.

Printer Server

Server Alias:
AE Title:
IP Address: Time Out

Port Number:

Worklist Filter:

Exam Date Today Next 2 Day Next 3 Day Next 7 Day Date Range

From To
Modality All RF XA CR SC

Enter information above on the “Schedule Filter” screen. The users will enter additional information on this
screen.

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Will the site use Storage & Commitment Servers Server? Yes No

If yes, record their configuration here.

Storage Server & Commitment Servers Server

Server Alias:
AE Title: IP Address:
Time Out Port Number:

Send RDSR on complete or Discontinue

Image: RF XA CR SC
Dose Summary: RDSR SC
Overlay: Never Send Always Send If Available

Enable storage Commitment

Use Storage Server Settings


AE Title IP Address
Time Out Port Number

Will the site use Query & Retrieve? Yes No


If yes, record their configuration here.

Query & Retrieve Server

Server Alias:
AE Title:
IP Address: Time Out
Port Number:
Information Model Study Root Patient Root

Local settings:

Local Listening Port:


Time Out:
Days to Cache Retrieved images:

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Will the site use MPPS Feature? Yes No


If yes, record their configuration here.

MPPS Feature Server

Server Alias:
AE Title:
IP Address: Time Out
Port Number:

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3.6.8 Printer

The system can support Sony printers UP-D898MD/UP-X898MD/ UP-971AD/ UP-991AD.


If the system can’t find the printer driver, FSE needs to follow the instruction to configure the printer driver.
1. Connect the power cable and USB cable to Sony printer.
2. Power on Sony printer.
3. Press the menu button and scroll down or up to select DIGITAL option.

4. Press the menu button and scroll down or up to select DRIVER option.

5. Press the menu button and scroll down or up to select corresponding legacy driver for new Sony
printer.
DRV: 897 for UP-D898MD/ UP-X898MD

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DRV: 970 for UP-971AD

DRV: 990 for UP-991AD

6. Functional check: Power on the system and turn on the printer. Verify that an image can be printed to
the printer and the printer works with both paper and film (film only for UP-991AD).

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3.7 Functional Check


3.7.1 System Movement Check
1. Push the C-arm system and verify that the wheels roll smoothly without vibration.
2. Verify that both side brake pedals function. Press the brake pedal to the brake position to lock the
system’s wheel and steering handle.

Brake Pedal
Free Position

Press the brake to free position to release the system’s wheel and steering handle. The pedals are located
on each side of the system.

Brake Pedal
Brake Position

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3.7.2 Mechanical Movement Check


Monitor and Arm Movement Check
1. Unlock the extension arm, to verify that extension arm can be freely moved.
2. Unlock the spring arm lock, hold the monitor handle to verify that the monitor can be free tilted and
move freely.

Tablet Movement Check


1. Hold the tablet to verify that it can be tilted freely.
2. Verify that tablet can be rotated freely.

Wig-wag Movement Check


1. Release the wig-wag brake.
2. Move the mechanics through the entire operational range. Verify that wig-wag brake has ease of
movement without excessive play.
3. Place the wig-wag brake in the locked position.
4. Verify the C-arm does not move.

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Horizontal Movement Check

1. Unlock horizontal brake and fully extend and retract the horizontal cross-arm.
2. Verify that the cross-arm moves smoothly and quietly through the bearing block without excessive
play.
3. Place the cross-arm brake in the locked position.
4. Verify that the cross-arm does not move.

Make sure cross arm is fully retracted and brake is set before moving C-arm. Otherwise, equipment damage
or personal injury may occur.
Orbital Rotation Check:

When you release the orbital movement brake, place your other hand on the C-arm so that
C A U T IO N
you can control its movement.

1. Release the orbital brake.


2. Verify that C-arm orbits smoothly in its cradle without excessive play.
3. Verify that the entire orbital scale is readable and in good condition.
4. Set the brake handle to locked position and verify that C-arm locks firmly in position.
Lateral Rotation Check:
1. Release lateral rotation brake.
2. Verify C-arm rotates smoothly in both directions.
3. Lock the brake and verify the brake locks C-arm firmly in position.
Before transporting the system, please make sure the brake handles: the C-arm orbital
WARNING rotation brake, the lateral rotation brake, both wig-wag brakes, and the horizontal cross-
arm brake are locked. Otherwise, equipment damage or personal injury may result.

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3.7.3 Vertical Column Operation Check


Power on the system. The vertical column motor is actuated by pressing the up and down vertical column
switches located on top cover of the mainframe. Use the vertical column to elevate the C-arm upward and
downward.

Press and hold or button to lift or lower the C-arm, the movement continues until the switch is
released or the movement reaches its limit. The maximum distance is about 40cm.
When C-arm can not be driven down by only pressing down switch, please release the switch and make
sure there are no obstacles between the C-arm and the T-Base. Make sure there are no obstacles between

cross-arm and console. Press the button one more time, it will lower C-arm to the lowest position.

Please make sure C-arm will not be blocked by any other objects during the vertical
WARNING movement. If there are any obstacles, system will sound two beeps and stop movement.
Please check and clear the obstacle. Then you can continue to raise or lower the C-arm.
If any failure occurs, please contact GE Healthcare authorized service engineer.

When positioning the vertical column, observe the moving assemblies to ensure the safety
of patients and hospital personnel.

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3.7.4 System Control Check


Home Panel Function Check

Using the spatial resolution tool as a phantom, take an exposure in normal fluoro mode and
NOTE verify the following functions in the tablet control panel.

Click the Image Rotation buttons to verify the image rotation is functioning.

Click the Image Reversal buttons to verify the image reversal is functioning.

Click the Field Size key button to verify the image intensifier field size is functioning.
Press each of the following collimator buttons while taking exposures and verify each of the following
collimator actions:

Click the Shutter Collimator Rotation buttons to verify the shutter collimator rotation is
functioning.

Click the Shutter Collimator Open/Close buttons to verify the shutter collimator open/close is
functioning.

Press the Iris Collimator Open/Close buttons to verify the iris collimator open/close is functioning.

Click the Low Dose button to verify the low dose mode can be selected.

Click the Noise Filter button to verify the noise filter is functioning.

Click the High Level Fluoro Mode & Digital Spot Mode button to verify the high level fluoro mode &
digital spot mode are functioning.

Click the Pulse button to verify the pulse function is functioning.

Click the Alarm Reset button to verify the alarm reset function is functioning.

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X-ray Panel Function Check

Click the auto exposure parameter button to verify the kVp level & mA level can be adjusted
automatically. The LED light will illuminate.

Click the kVp buttons to verify the kVp level can be adjusted manually. The LED light will be off.

Click the mA buttons to verify the mA level can be adjusted manually. The LED light will be off.
In the working mode, when the footswitch/hand switch is activated to take an exposure, LIVE/LIH label will
display on the monitor.

Key switch is placed in X-ray off position or standby position , X-ray is disabled and message will
show on monitor and tablet.

Click the Film mode button and verify that the indicator is on.(It is not available in version 2 series
system.)

The button is to disable/enable HLF mode/dig. spot mode. This key only works in Australia.

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Image Panel Function Check

Click the Noise Filter buttons to verify the noise filter level can be adjusted manually.

Click the Edge Enhancement buttons to verify the edge enhancement level can be adjusted manually.

Click the Negate button, the light will be on and verify the negate function can be enabled.

Click the Auto Smart Metal button to verify the smart metal level can be adjusted automatically. The
LED light will illuminate.

Click the Smart Metal buttons to verify the image of metal can be adjusted manually. The LED light will
be off automatically.

Click the Auto Brightness/Contrast button to verify that the brightness and contrast level can be
adjusted automatically.

Click the Contrast buttons to verify the contrast level can be adjusted manually. The Auto Brightness/
Contrast will be off automatically.

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Press the Brightness buttons to verify the brightness level can be adjusted manually. The LED light will
be off automatically.

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Installation

Vascular Panel Function Check

This option is only available in version 2 series system.


NOTE

Roadmap mask

Touch roadmap mask to verify that the image in the control panel left part was set as roadmap mask and
the exposure mode can be switched to Roadmap-2.

View Subtracted
Touch View Subtracted to verify that the subtraction view is enabled/disabled. If the View Subtracted
button is highlighted, the cine run displays in subtracted form. To view the cine run in unsubtracted form,
touch View Subtracted again, the button is no longer highlighted and the cine run displays unsubtracted.

Peak Opacify
Touch Peak Opacify to verify that is peak opacification enabled. Use the Peak Opacify button during post-
processing to view a subtraction run with opacification.
The areas darkened by the contrast media remain dark in the playback of the run, providing maximum
vessel display.
Peak Opacify button is not used for Roadmap function, roadmap-1 is always with peak opacification.

Set Mask
Use the Set Mask button to verify that another mask for a post-processing subtraction on the left side of
the monitor is set during subtracted cine playback.

Mask Registration
Use the mask registration buttons to verify that the mask image with the incoming images has been
aligned. Touch Reset on the screen to restore the mask to its original position.

Landmarking

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In some subtracted images, it may be necessary to see the position of vessels in relation to certain
background anatomies. Landmarking allows you to vary the percentage of background anatomy that
displays in a subtracted image. This function is available for subtraction and roadmap function.
Touch the landmarking button or drag the progress bar slider to vary the percentage of background
anatomy.

Reference Image Hold


Use reference image switch button to switch the image displayed in the right monitor part between live
image and reference image setted by user. It can be used in the subtraction or roadmap mode.

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Key Switch, Footswitch and Hand Switch Functional Check


Perform the following test to verify that key switches, footswitch and hand switch are operating
satisfactorily.
This procedure produces X-rays. Take appropriate precautions.
WARNING

1. Place the X-ray key switch in standby position . Press hand switch/footswitch and verify that no X-
rays are generated. Press vertical lift button and verify that vertical lift column is not operational.

2. Place X-ray key switch in X-ray off position . Press hand switch/footswitch and verify that no X-rays
are generated. Press vertical lift button and verify the vertical lift column is not operational.

3. Place X-ray key switch in on position . Press hand switch/footswitch and vertical lift button to verify
X-ray and vertical lift column are enabled.

Emergency Switch Check


1. Press the emergency switch during raising C-arm.
2. Verify that vertical column operation and exposure are disabled.
3. Release the emergency switch. Verify that the vertical column
operation and exposure are available.

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3.7.5 System Operation Check

The monitor provides a touch screen for interacting with the system. Using the touch screen button to verify
those functions.

UI for version 1 system

UI for version 2 system

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1. Click the button to verify the setup function, which allows you to enter the setup screen.

2. Click the button to verify the patient information function, which allows you to enter the patient
information screen.

3. Press the Cine button to display the cine setting and playback functions, if customer purchased
the option.

4. Click the button to verify the image directory function, which allows you to enter the image
directory screen.

5. Click the button to verify the annotation function, which allows you to enter the annotation screen,
if customer purchased the option.

6. Click the button to verify the measurement function, which allows you to enter the image
measurement screen, if customer purchased the option.

7. Click the button to verify the zoom function, which allows you to enter the zoom function screen.

8. Click the button to verify the DICOM Q/R function, which allows you to enter Q/R screen, if
customer purchased the option.

9. Click the button to verify the relevant function, which allows you to the image processing control
panel screen.

10. Press the button to verify the save function, which allows you to save the images to the system disk.
(for version 1 series system)

11. Press the button to verify the save function, which allows you to save the images to the system
disk. (for version 2 series system)

12. Press the button to verify the cine save function, which allows you to save the last exposure as
cine to the system disk, if customer purchase this option. (for version 2 series system)

13. Press the button to verify the swap function, which allows you to exchange images between the
left monitor and the right monitor.

14. Press the button to verify the logout function, which allows you to log out of the system.

15. Press the button to verify the blank function, which allows you to enter the blank screen. Then
press any area on the monitor to re-display.

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The logout function can only be available when you select “Require Users to Login” on the
NOTE
“Security” screen of setup interface.

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Dynamic Recording
Dynamic recording (cine) option is only available in version 2 series system.
NOTE

System provides dynamic recording (cine) saving option. Press the Cine button to display the cine
screen and operate on the screen to verify image modes for cine recording, continuous acquisition rate
and cine review function. For the detailed information, refer to Vascular User Manual Supplement.

TechView Tablet (control panel) as shown in the picture below, enables to review the previous/ next cine
run, move back/forward by a single frame and pause, begin or resume cine playback. Refer to Vascular
user Manual Supplement to verify these functions.

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3.7.6 Dose Limitation Check


Normal Fluoro Dose Rate Check
1. Position the C-arm with the generator above the image intensifier.
2. Position the detector of dosimeter at the center of the X-ray beam 30cm above the grid of image
intensifier. Cover the image intensifier with lead plate thicker than 3mm.
3. Set kVp as 110kVp, set mA as 4mA in manual mode. Measure the dose rate while making exposure.
Limits vary by the dose group, which was configured by country in software configuration section.
4. Verify the corresponding dose group according to country’s dose group requirement in Section 3.6.4
exposure management matrix.

Continuous Fluoro: ≤ 47.5mGy/min (Dose group: Normal 50 and HLF 50)

≤ 47.5mGy/min (Dose group: Normal 50 and HLF 100)


≤ 83.6mGy/min (Dose group: Normal 88 and HLF 100)

HLF Dose Rate Check:


1. Position the detector of dosimeter in the center of the X-ray beam 30cm above the grid. Cover the
image intensifier with lead plate thicker than 3mm for protection of the image intensifier.
2. Set kVp as 110kVp, increase mA to maximum in manual mode. Measure the dose rate while making
HLF exposure. Limits vary by the dose group, which was selected by country in software configuration
section.
3. Verify the corresponding dose group according to country’s dose group requirement in Section 3.6.4
exposure management matrix.

Continuous Fluoro: ≤ 47.5mGy/min (Dose group: Normal 50 and HLF 50)


≤ 95mGy/min (Dose group: Normal 50 and HLF 100)
≤ 95mGy/min (Dose group: Normal 88 and HLF 100)

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3.7.7 Beam Alignment Check

Refer to Section 4.6 Beam Alignment Check and Adjustment.


1. If any regulatory body or user requires that the collimator be visible in the image, the
NOTE service engineer could select “The collimator iris is required to be visible in FOV” to
calibrate it.
2. German regulations require that the collimator must be visible on two sides of the image,
which are not opposite. For the systems installed in Germany, adjust the collimator iris
until the leaves are visible as pictured below.

3. Australia regulations require that the beam limiting device must automatically limit the
primary beam to X-ray image receptor area (within 1% SID), which it must set to the
selected field of the I.I. or image receptor in the fluoroscopic mode. For the systems
installed in Australia, adjust collimator iris until the collimator 8 leaves can be seen in the
image.

3.7.8 Collimator Calibration Check


Refer to Section 4.9 to check collimator iris.

3.7.9 ABS Tracking Check


1. Make sure that X-ray tube cover is installed.
2. Position the C-arm with I.I. above the X-ray tube.
3. Select auto fluoroscopy mode, and the norm field size to take an exposure. Put the 1mm, 2mm, and
3mm copper filter on the tube head.
4. Verify that the kVp stabilizes in the specified range below for each copper filter thickness:

Copper Filter Thickness 1mm 2mm 3mm


kVp range 64±4kVp 74±4kVp 82±4kVp
5. If the ABS tracking check fails, perform kVp accuracy check. If kVp accuracy check passes, perform
entrance dose rate check and camera iris adjustment.

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3.7.10 Image Resolution Check


Place spatial resolution tool in the front of the image intensifier. The angle between the horizontal axis of
the image and the resolution tool must be 45°. Select the auto fluoro or set the appropriate kV value. Take
an exposure and stop once image is stable. The image is frozen on the left area of monitor. Verify the
resolution in the specified range below for each field size (MAG NORM, MAG1 and MAG2).
Field Size MAG NORM MAG1 MAG2
Resolution (Lp/mm) ≥ 2.2 ≥ 2.8 ≥ 3.3
If the resolution check fails, refer to Section 4.12 Camera Focus Calibration.

3.7.11 DAP Accuracy Check


Refer to Section 4.14 to do DAP accuracy check.

3.7.12 System Status Backup


Export system setup and administration configuration, if needed.

3.7.13 Fill in the product Locator Card


After the installation, please fill in the product locator card for PLC parts below and mail the
NOTE cards to local service operation office.

Item Part No. Description Comments


1 7000888 ASM, OEC One System Only for version 1 series system
9000888 ASM, OEC One System Only for version 2 series system
2 5075400 ASM, Collimator Kit FRU PN: 5075984
3 5085004 ASM, Monoblock Kit N/A
4 5085917 ASM, 9' Image Intensifier Kit FRU PN: 5075967
5 6491850 ASM, GigE Camera GE1020C FRU PN: 7491850
6 5075916 ASM, Tube Cover with Laser Aimer Kit Option
7 5085005 Cassette Holder Option, Only for version 1 series system

3.7.14 GESAK Not Installed Check


After the system service, FSE needs to shut down the system and then confirm that the GESAK has been
removed from the system.
It is only available in version 2 series system.
NOTE

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3.8 Options Installation


3.8.1 Laser Aimer
Laser Aimer of Monoblock
1. Paste multi language label and laser warning label.

2. Laser Aimer, which attaches to monoblock, is incorporated with the collimator cover. Remove the
standard collimator top cover. Position the collimator cover with laser aimer and plug the power cable
with laser label on connector in bundle cable. Tighten the fixed screws of the collimator cover. Remove
the laser aimer cover. Power on the system.

3. Install the BAFT to I.I. and adjust BAFT center to image center.
4. Press the laser aimer’s green power switch to generate the laser beam.

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5. Loosen the set screw so that you can adjust the beam by the adjuster.

6. Adjust the adjusters of the laser until the intersection of the laser beam is in the center circle of the
beam alignment tool. (Use the circle to adjust the line to be across the other, and the screw to adjust
the position of the line.)
7. Fasten the fixed screw a little. And the beam position will change a little. Then adjust the beam again
according to step 5. Fasten the fixed screw to fix the beam position and direction. Then install the laser
aimer cover.

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8. Functional check: turn on the laser aimer power switch and verify that the intersection of the laser
beam is in the center circle of the beam alignment tool and the two laser lines are crossed.

9. Paste laser aiming device label (refer to Section 1.2.11) next to the collimator top cover as shown in the
below picture.

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Laser Aimer of Image Intensifier


Perform the following procedure to install and operate the laser aimer on the image intensifier. The C-arm
can be placed in any orientation that is convenient to attach the laser aimer. There are no alignment marks
or notches on the laser aimer that need to match any points on the image intensifier.
1. Check labels. If there are no labels on the system, paste them on the position as shown in the below
picture.

When the laser aimer is attached to the C-arm, releasing the orbital or rotational brake could
C A U T IO N
cause the C-arm to move. Make sure to hold the C-arm to control its movement whenever a
brake is released.
2. Place the laser aimer attachment handle in the open position.
3. Move the laser aimer flush with the image intensifier, but slightly off center.
4. Center the laser aimer in relation to the image intensifier. As you center the laser aimer, the attachment
hooks catch on the edge of the image intensifier.
5. Turn the attachment handle inward until the handle is completely closed and the laser aimer is
securely attached to the image intensifier. Insert the metal bolt into the hole of the handle to lock.
Do not grasp the laser aimer's handle to position the C-arm or to move the system. Pulling
C A U T IO N
the handle may cause the laser aimer to release from the image intensifier and fall.

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6. Use the C-arm handle to position the C-arm, then move the system to the desired location.
7. Turn the laser aimer on and adjust the beam alignment knobs until the laser beam is centered on the
intersection of the cross-hairs on the monoblock cover.

If the laser is on, do not look directly into the laser aimer’s aperture.
C A U T IO N

8. Functional check: verify that the cross-hairs are in the fluoro image, at the center of the area of interest.

The location where the laser beam marks the patient corresponds to the center of the area
NOTE of interest, indicated by the cross-hairs in the fluoro image.

Perform procedures below to remove the laser cover from the laser aimer:
1. Switch off the power to the laser aimer.
2. Grasp the two knobs on the laser cover.
3. Press down and rotate the cover (approximately 10 degrees counterclockwise) until the knobs align
with the notches on the housing.
4. Lift off the cover and resume laser aimer operation.

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3.8.2 Film Cassette Holder


This option is only available in version 1 series system.
NOTE

Please follow the steps below to install and remove the cassette holder:
1. Place the cassette holder over the surface of the image intensifier with the handle opened.
2. Rotate the cassette holder handle to securely attach the cassette holder to the image intensifier.
Verify that the cassette holder is securely attached to the image intensifier. Unsecured
WARNING cassette holder may fall, and injure patient or personnel.

3. Insert a film cassette into the cassette holder and center it.
The cassette holder uses friction to hold the cassette.
NOTE

Verify that film cassette is held securely within the cassette holder. Unsecured film cassettes
WARNING may fall, injuring patients or personnel.

4. Remove the film cassette by pushing the cassette out of the cassette holder.
5. To remove the cassette holder, open the cassette holder handle and press firmly against the side of the
cassette holder.
The cassette holder is designed to attach to the image intensifier lip when the handle is
NOTE engaged. It may be necessary to strike the cassette holder with the palm to dislodge the
cassette holder from the image intensifier.

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3.8.3 Removable Filter and Sensor Installation


Install the sensor
1. Remove the collimator cover.
2. Assemble each sensor into collimator cover by two fixed screws and secure the cable.

Pay attention to the direction of sensor, wrong sensor direction will not detect filter.
NOTE

3. Connect the connector of sensor to J10/J11 which are from bundle cables.
4. Install the collimator cover.

5. Check the multi-language label on the filter.

6. Install the filter. Have the filter locked by the bolt of collimator top cover, by turning the filter clockwise.

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7. In product config interface (in software service mode), check the checked box of filter.
8. Reboot system and login software service tool interface calibration tab, the DAP calibration with filter
button will be activated and perform DAP calibration with filter.

If the DAP calibration with filter button is not activated, recheck the connection of all cables
NOTE and connectors.

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3.8.4 Removable Grid


Structure of Remove Grid
Check the multi-language label on removable grid support.

Removable Grid Support Carbon Protection Board

White dot is the direction mark for grid. The White dot is the direction mark for grid. The
connected line of direction mark is in 45° with connected line of direction mark is in 60° with
C-arm (For version 2 series system).
C-arm (For version 1 series system).

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Assemble and Install Removal Grid


1. Remove the grid by releasing the screws from image intensifier.
2. Install the carbon protection board into image intensifier.
3. Install removable grid holder on image intensifier.

Ensure the localizer bolt of removal grid holder is in the slot of image intensifier.
NOTE

4. Install grid on removable grid holder and ensure the direction of grid as pictured below.

Grid for version 1 series system Grid for version 2 series system
5. The removable grid is ready for use.

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3.8.5 Tube Skin Spacer


Paste the multi-language label on skin spacer.

Install the skin spacer using the following steps:

Skin Spacer Small Monoblock Cover


1. Turn skin spacer 180°.
2. Insert skin spacer into collimator top cover as pictured on the right.
3. Then turn the skin spacer clockwise to lock it onto collimator top cover.

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3.8.6 Video Distributor


Installation time: one field service engineer one hour.
NOTE

Video Distributor Option Packing List

Item Parts No. Parts Name QTY

1 6888893 DVI collector 1

2 6888169 Sheet metal, DVI box bottom 1

3 6888819 PWA, DVI splitter board 1

4 6888170 Sheet metal, DVI box top 1

5 1000-M4C006-04 Hexagon Socket Head Cap Screw 6

6 1000M4C00804SFW 1000-M4C008-04+2000-M4-02 10

7 6888767 Cable ASM, DVI, computer - DVI Splitter 1

8 N/A Label, DVI Collector Chinese 1

9 N/A Label, DVI Collector English 1

1. Power off the system. Remove the rear and front covers.
2. Disconnect cables from SIB board side.

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3. Remove the fixed screws of external interface panel and remove the frame.

4. Remove the video output port dam-boards as pictured below.

5. Setup BNC signal output.


The system video distributor can output the left area video signal of the image on the monitor to the
external display device by NTSC/PAL format.
The video splitter support “NTSC/PAL” and “16:9/4: 3” video signal output for the external display device,
the default setting is PAL/4:3 mode.
Default setting (PAL and 4:3) is working with Analog Sony printer (UP970AD).
U11 (switch1) U11 (switch2)
PAL/NTSC BNC Output 16:9/4:3 BNC Output

ON PAL ON 4:3
OFF NTSC OFF 16:9

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6. Assemble the Video Distributor board with box. Paste the label as pictured below.

7. Fix the video distributor box to the external interface panel.

8. Reinstall the external interface panel frame to system, do not fix it now.
9. Recover SIB cables.
10. Connect the video input cable and the power cable (J6) to video distributor box.
11. Connect the video cable to the computer and secure it.
12. Connect the external monitor for the functional check:
Verify the NTSC/PAL video signal output port can output system monitor left area image to the external
monitor. Verify the DVI-D output port can output system monitor all area image to the external monitor.
13. Fix the external interface panel frame to system, and recover system.

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3.8.7 Advanced Wireless Module


Installation time: one field service engineer two hour,
NOTE

Advanced Wireless Module Option Packing List

Item Parts No. Parts Name QTY

1 6888961 WIFI collector 1

2 5999915 Moxa Module 1

3 6888811 MOXA Model Kit 1

Advanced wireless module kit includes 13 parts:


1. Power Cable

2. Antenna Cable (A)

3. Antenna Cable (B)

4. Switch

5. Screws

6. On/Off switch cable

7. Cable Ties

8. Antenna Bracket (2units)

9. Wireless label with FCC/IC ID

10. Ethernet Cable

11. Wireless Module

12. Wireless Antenna (2units)

13. Wireless label without FCC/IC ID

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Wireless module hardware integration


1. Remove the front cover and the rear cover.
2. Connect Ethernet cable (WIFI LAN) to the wireless module as pictured below.

Make sure the WIFI LAN terminal is connected to the wireless module.
NOTE

3. Secure the Ethernet cable, then connect the Ethernet cable to computer ETH2 port as pictured.

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4. Fix the wireless module to the system frame by the two screws as the picture below.

5. Connect the power cable and two antenna cables to the wireless module as the picture below.

Make sure the connection of the power cables are correct as the picture below shows.
NOTE

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6. Secure cables as the picture below.

7. Fix the antenna cable head (long) to the system frame by tightening the nuts. Then fix the antenna
bracket by tightening the screws as the picture below.

8. Fix the antenna cable head (short) to the system frame by tightening the nuts. Then fix the antenna
bracket by tightening the screws as the picture below shows. 

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9. Disconnect the cables from SIB board side.

10. Release and remove four screws of the external interface panel.

11. Remove the dam-board as picture below. Then fix the wireless switch to the external panel.

Make sure the "O" position is at the bottom.


NOTE

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12. Connect the on/off cable to the switch and the J8 system interface board.

The brown cable is at the top.


NOTE

13. Connect the other end of the power cable to the J5 system interface board.

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14. Reinstall all cables.


15. Reinstall the screws of the external interface panel.
16. Reinstall the front cover and rear cover.
17. Attach the WiFi and FCC label to the printer cover as shown in the picture below. Verify that the install
label is the same as in the picture shows below. If not, replace the old label with WiFi and FCC label as
shown in the picture below.

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Country setup
1. If needed, please remove computer cover.
2. Access an external laptop/computer and disconnect all wireless/wire connections in extra laptop/
computer.
3. Disconnect the network cable (ETH2) from the computer.
4. Connect the Ethernet cable (ETH2) to extra laptop/computer.
5. Power on system.

6. Open Internet Explorer on extra laptop/computer. Select the “ ” button, then select the “Internet
Options” button.
7. On the “Internet Options” screen, click the “Connections” button, then click the “LAN settings” button.

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8. On the Local Area Network (LAN) Settings screen, uncheck the “Use automatic configuration script” and
“Use a proxy server for your LAN” options.

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9. Click the Internet access button, then click “Open Network and Sharing Center” button.

10. On the “Network and Sharing Center” screen, click the “Local Area Connection” button.

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11. On the “Local Area Connection Status” screen, click the “Properties” button.

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12. On the “Local Area Connection Properties” screen, double click the “Internet Protocol Version 4 (TCP/
IPv4)” button.

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13. Setup static IP, select “Use the following IP address” and “Use the following DNS serve address”. Then
set the IP address to 192.168.43.241, set the Subnet mask to 255.255.255.240, set the Default Gateway
to192.168.43.242. Click the “Ok” button.

14. Open the IE. Then input http://192.168.43.242/login.asp, input password: root.

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15. Input http://192.168.43.242/country.asp, click drop down list to select a device country, then click
submit.

Please refer to the following table to select the device county:


Items Installed Country/Region Device Country selection
1 Australia Australia
2 Austria Europe

3 Belgium Europe

4 Brazil United States


5 Bulgaria Europe
6 Canada United States
7 China China
8 Croatia Europe
9 Cyprus Europe
10 Czech Republic Europe
11 Denmark Europe
12 Estonia Europe
13 Finland Europe
14 France Europe
15 Germany Europe
16 Greece Europe
17 Hong Kong United States
18 Hungary Europe
19 Iceland Europe
20 India Europe
21 Ireland Europe
22 Italy Europe
23 Japan Japan
24 Korea Korea
25 Latvia Europe
26 Liechtenstein Europe
27 Lithuania Europe

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28 Luxembourg Europe
29 Malta Europe
30 Netherlands Europe
31 New Zealand Australia
32 Norway Europe
33 Poland Europe
34 Portugal Europe
35 Romania Europe
36 Slovakia Europe
37 Slovenia Europe
38 South Africa Europe
39 Spain Europe
40 Sweden Europe
41 Switzerland Europe
42 Taiwan United States
43 Turkey Europe
44 United Kingdom Europe
45 United States United States
16. Power off system.

17. Unplug Ethernet cable from laptop/computer.

18. Reconnect Ethernet cable to computer Ethernet card.

19. Reinstall all covers.

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Wireless Performance Check

 
1. Power on system, log in and click “ ” button. In “Network & DICOM” tab, click “Configure…”
button in “Wireless Network” area.

2. Enter “Wireless Network Config” screen to set the local language, then click the “Apply” button.

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3. Select the “DHCP” button to set up DHCP IP, then click the “Apply” button.

If you need to set up static IP, select the “Static” button, and add the WLAN information as pictured
below, then click the “Apply” button.
The system is incompatible with the IP 193.268.43.XXX and 192.168.42.XXX.
NOTE

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4. Click the “Please click the button search a SSID” button to add or replace wireless network, then display
the SSID list.

5. Configure EAP protocol, wireless module has three EAP protocols for customer:
TLS, TTLS (PAP, CHAP, MS-CHAP, MS-CHAP-V2) and PEAP(MS-CHAP-V2).

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6. Input the SSID wireless network password to "Passphrase". Then click the “Join” button.

7. If the SSID wireless network is authorized through certifications, complete the sub-steps below a-e to
set the wireless network. If not, go directly to the step 8.
a. FSE needs to import the certifications to system by USB disk. Click the “Import Certificate File”
button. On import certificate file screen, select the USB disk then find the import certificate file name
which is the correct one to import to system. Click the “Import” button.

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b. Click the “OK” button to complete the certificate file import. 

c. Click the “Close” button to exit the screen.


d. Input the password to “WLAN certificate private password”. Then click the “Join” button.

e. After completion, click “Close” button to exit the screen.


8. Test the wireless network function.

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3.8.8 Wireless Footswitch


The wireless footswitch consists of a remote-control transmitter and a receiver. The wireless footswitch for
the operator is to initiate and release the X-ray radiation, save image and switch imaging mode pair, instead
of the wired footswitch. It provides identical functionalities to the system as the wired footswitch.
For detailed information about technical specifications and operation instructions, refer to Operator
Manual Supplement.
Wireless footswitch is only available in version 2 series system.
NOTE

Wireless Footswitch Installation


1. Remove battery cover and install three new 1.5 volt size C (LR14) batteries. Ensure that the battery
orientation and polarity match the indication on the footswitch battery compartment.

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2. Press the foot pedal to check whether the battery light illuminates. Green light indicates that batteries
are installed successfully.

3. Remove rear cover and front cover from system.

4. Remove the front small cover as shown in the picture below.

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5. Fix the receiver holder with three screws as pictured below, then restore front cover after installing.

6. Connect the cable to receiver.

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7. Position receiver into the holder and connect the plug to socket as shown in the picture below.

8. Remove the cover on the base rear cover as pictured below.

9. Install footswitch holder with screws as shown in the picture below.Restore the cover.

10. Power the system to perform functional check. Check the light on the receiver to make sure that
receiver works.
11. Footswitch rating plate label should be in local language according to the regulation requirement. If
not, the local FSE needs to replace or cover it with the label in local language.

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Rating Plate label

12. Position footswitch into the holder as shown in the picture below.

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3.8.9 Wired Foot switch


Wired foot switch with 4 buttons is only available in version 2 series system.
NOTE
Wired foot switch with 3 buttons is only available in version 1 series system.

There are two kinds of wired footswitches provided as option:


Footswitch with 5 m cable and footswitch with 10 m cable.
Wired Footswitch Installation
1. Plug the footswitch cable to the footswitch socket on the system, then power on the system to perform
the functional check.

Footswitch with 5/10 m cable (3 buttons) Footswitch with 5/10 m cable (4 buttons)
2. Footswitch rating plate label should be in local language according to the regulation requirement. If
not, the local FSE needs to replace or cover it with the label in local language.

Rating Plate Label

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3.8.10 Cine and DSA & Road Map


All of cine and DSA & Road map options are not available in version 1 series system.
NOTE
Installation time : one field engineer two hours.

Cine Option Packing List

Item Parts No. Parts Name QTY

1 5804187 Option Cine8 1

1 9888961 Work station, Solid state drive, Surgery 1

Part Number and Photo:


P/N: 9888961 Computer solid state drive (SSD) kit

Table 3-1 Cine and DSA & Road map Options List

Option Description Comments

Cine SSD;
1 Software Option Cine8 + SSD kit
Cine Recording Frame Rate: 1 fps, 2 fps, 4 fps, 8 fps;

X-Ray Pulse Rate: 12 PPS;


2 Software Option Cine12 Cine Recording Frame Rate: 1 fps, 2 fps, 4 fps, 8 fps,
12 fps;

X-Ray Pulse Rate: 12 PPS;


3 Software Option Cine25 Cine Recording Frame Rate: 1 fps, 2 fps, 4 fps, 8 fps,
12 fps, 25 fps

4 Software Option DSA&Roadmap Include Subtract and Roadmap

Only cine 8 option includes cine hardware (SSD kit) option, so combine the other three
NOTE options and cine 8 option to make the all of the cine and DSA & Roadmap option works.

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1. Release the screw on the back of the computer cover and then remove the computer side cover.

2. Verify that there are four screws on the SSD bracket which is above the computer power. Check to see
whether the power cable and signal cable have been pre-installed and fixed on the SSD bracket.

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3. Open SSD package and take it out.

4. Align the four screws on the SSD with the four studs on the SSD bracket, and then tighten the screws
to fix the SSD to the SSD bracket.The tightening torque is 0.5±0.05N.M.

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5. Cut cable ties and take SSD power cable and signal cable out.

6. Connect the SSD power cable and signal cable to the SSD.

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7. Restore the computer side cover and tighten screws. The tightening torque is 0.5±0.05N.M.
8. Active E-license. For detailed instruction, refer to Section 5.2.2.
After installing DSA & Road map option, disabling “Automatic Termination at 20” in
NOTE
one shot" is preferred under the condition permitted by regulation. Some countries or
regions, such as Australia or Switzerland, may require enabling it.
9. Enter the SVC mode (administration) with GESAK and select "Maintenance" tab. Then click "Format Cine
Disk" to format the SSD. After formatted, click "Data Integrity Check" to check the data integrity. Then
click the "Shutdown" button to shutdown the system.

10. Power on the system. Then check whether "Cine Storage Status" bar appears on the status bar. The
"Cine Storage Status" bar indicates that the SSD has been successfully installed and configured.

11. Make fluoro exposure and press the cine save button to check if cine option works well. For detailed
check instruction, refer to Operator Manual Supplement.

12. Verify DSA&Roadmap function if customer purchased the option, refer to vascular panel function
check in section3.7.4 .

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3.9 Room Interface


Room Interface (RIF) is an interactive interface with operation room or some peripheral equipment. The
lamps in operation rooms such as "Room In Use" indicator or "X-ray On" indicator can be connected to
system to warn user, injector can be controlled by room interface if needed. All functions in RIF are not
mandatory when operating.

3.9.1 Enable Room Interface in Software UI


System provides a HDB15 connector as room interface output/input on the system rear cover as shown in
the picture below.

The door switch work mechanism should be configure in "Setup" UI of system at first. Select and check the
"Room Interface" to enable the function, and select "High" or "Low" as default for door opening voltage as
shown in the picture below.

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3.9.2 Room Interface Definition


In OEC One system, the room interface HDB15 connector is system interface board J4. The system interface
board with different definition of J4 pin in two revisions (PN 688805-1 Rev 3 and Rev 4) separately.
Check the system interface board PWA label revision first.
• If PWA label revision is 6888805-1 Rev3, refer to the steps in item1.
• If PWA label revision is 6888805-1 Rev4, refer to the steps in item2.
The system interface board PWA 6888805-1 revision label as shown in the picture below.

1. The system interface board (PN 6888805-1) Rev 3 is green colour as shown in the picture below.

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For Room Interface (RIF) connection, the rules listed below shall be complied with:
a. All equipment and power connected to RIF shall be UL/IEC60601 certified.
b. For “Room in Use Indicator”, the power shall be less than DC 36V, and current shall be limited within 2A.
The connection diagram is recommended.
Power
Room Interface V < 36VDC
I < 2A Room in Use
Pin _ 14 Indicator

Relay Switch

Pin _ 15 R

c. For “X-ray On Indicator”, the power shall be less than DC 36V, and current shall be limited within 2A.
The connection diagram is recommended.
Power
Room Interface V< 36VDC
I < 2A Xray on
Pin _ 9
Indicator

Relay Switch

Pin _ 10 R

d. For “Injector in Use Indicator”, the power shall be less than DC 36V, and current shall be limited within
2A. The connection diagram is recommended.
Power
Room Interface V < 36VDC
I < 2A
Pin _ 4

Relay Switch Injector

Pin _ 5 R

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Installation

e. For “Door Open Detector”, a rated 24VAC is needed to drive an AC relay in internal circuit, the door
switch status will be detected by system. The connection diagram is recommended.

Room Interface
Door Switch
Pin _ 1

AC Relay
Coil
Power
V= 24VAC
Pin _ 11

2. The system interface board (PN 6888805-1) Rev 4 is blue colour as shown in the picture below.

For Room Interface (RIF) connection, the rules listed below shall be complied with:
a. All equipment and power connected to RIF shall be UL/IEC60601 certified.

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OEC One Mobile C-arm X-ray Product

b. For “Room in Use Indicator”, the power shall be less than DC 36V, and current shall be limited within 2A.
The connection diagram is recommended.
Power
Room Interface
V < 36VDC
I < 2A Room in Use
Pin _ 3 Indicator

Relay Switch

Pin _ 8 R

c. For “X-ray On Indicator”, the power shall be less than DC 36V, and current shall be limited within 2A.
The connection diagram is recommended.

Power
Room Interface
V < 36VDC
I < 2A Xray on
Pin _ 2
Indicator

Relay Switch

Pin _ 7 R

d. For “Injector in Use Indicator”, the power shall be less than DC 36V, and current shall be limited within
2A. The connection diagram is recommended.
Room Interface Power
V < 36VDC
I < 2A
Pin _ 1

Relay Switch Injector

Pin _ 6 R

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Installation

e. For “Door Open Detector”, a rated 24VAC is needed to drive an AC relay in internal circuit, the door
switch status will be detected by system. The connection diagram is recommended.
Room Interface
Door Switch
Pin _ 4

AC Relay
Coil
Power
V = 24VAC
Pin _ 5

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OEC One Mobile C-arm X-ray Product

3.10 Reporting
For U.S. Systems
Complete and submit FDA Form 2579, this is to comply with FDA requirement to submit Form 2579 to the
FDA within 15 days of installation.

3.11 Installation Checklist


During the installation, the FSE needs to follow installation check list to check the system. Please find the
detailed check list in Appendix-1 OEC One Installation Checklist.

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Chapter 4 Calibration and Adjustment
OEC One Mobile C-arm X-ray Product

4.1 Overview
The calibration described herein should be performed each time you replace a major system component.
Perform these tests in sequence that appears in this section if necessary.
The following tools and test equipment are required to complete the calibration.

Standard Tool and Equipment


Item Tool and Equipment
1 Oscilloscope Tektronix 2236 or Equivalent
2 Multimeter or Equivalent
3 Spatial Resolution Tool
4 Lead Apron
5 kVp Meter
6 Dosemeter
7 Tape measure
8 Erasable Marker (whiteboard marker)
9 mAs Meter
10 Precision Flat Head Screwdriver (3mm or less) to adjust Camera Iris, Focus
11 Transparent Adhesive Tape, with Cutter (or need scissors or knife to cut the tape)
12 10’’×12’’Film (only need in version 1 series system.)
13 Jumper×2
GE Tool
Item Tool GE part number
1 Three Copper Sheets, each 1mm thick 00-877682-01
9’’ BAFT Tool or UBAT (Universal Beam
2 00-878105-02 or 5307604
Alignment Template)
3 PWA, Extend Board 5085609

4-2
Calibration

The system will produce X-rays when implementing the following procedures.
WARNING Take appropriate measures and precautions to protect yourself and others from X-ray
exposure.

Must obey the following steps to guarantee the safe operation of the C-arm. Improper
C A U T IO N adjustment may cause premature failure of major system components.
If the generator has not been powered for more than 3 months, perform the generator
warm-up procedure in section 4.5.

Provide appropriate X-ray protection on surface of image intensifier in non-related


NOTE calibration and verification to protect image intensifier.

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OEC One Mobile C-arm X-ray Product

4.2 kVp & mA Accuracy and Calibration


4.2.1 kVp Measurement and Accuracy
The X-ray generator is composed of high voltage transformer, high voltage rectifier and X-ray tube in one
pressurized oil tank. kVp value can be measured by kVp meter. Position the kVp meter in the center of the
X-ray beam 30 cm above the focal spot.
Take exposure at kVp values below in normal fluoro mode. The error should be within ±7% ranges.
Otherwise, perform the kVp adjustment procedure in section 4.2.2 until all the kVp values meet the
requirements below.
Exposure kVp Calculation Minimum Maximum
mA or mAs Set Value
Mode Value Error (kVp) (kVp)
Low Dose 99 kVp 2mA 7% 92.07 105.93
Normal 66kVp 4mA 7% 61.38 70.60
Fluoro 110 kVp 1mA 7% 102.3 117.7
High Level 55 kVp 4mA 7% 51.15 58.85
Fluoro 110 kVp 4mA 7% 102.3 117.7
Digital Spot 55 kVp 4mA 7% 51.15 57.75
80 kVp 4mA 7% 74.4 85.6
110 kVp 4mA 7% 102.3 117.7
Film 55 kVp 40mAs (For 100/110V/120V 7% 51.15 58.85
input)
80mAs (For 200V/220V/230V/
240V input)
80kVp 40mAs 7% 74.4 85.6
110 kVp 20mAs 7% 102.3 117.7

Film mode is only available in the version 1 series system.


NOTE

4-4
Calibration

4.2.2 kVp Calibration


1. Power off the system. Remove the system rear cover.
2. Enter Admin mode. Click “Calibration” tab, then click “kV & mA Calibration” button.

3. Check and rotate R40 and R27 on kVp control board clockwise to the end.
4. Connect oscilloscope to TP4 and TP6 (GND) on kVp control board, set the oscilloscope. Test TP4 to check
that the frequency is 80kHz±1kHz, if not, adjust R13 on kVp control board.
5. Set the multimeter to DC voltage mode. Connect multimeter to TP16 and TP6 (GND) on kVp control
board. The test voltage should be 3.15±0.05V. If not, adjust R109 on kVp control board, clockwise
rotation will decrease the voltage value and anticlockwise will increase the value.
Change and connect multimeter to TP17 and TP6 (GND) on kVp control board. The test voltage should
be 3.15±0.05V, if not, adjust R110. Clockwise rotation will decrease the voltage value and
anticlockwise will increase the value.
6. Set the multimeter to DC mA mode. Connect multimeter to TP222 (+) and TP210 (-) on extend board,
and remove the J46 jumper. Take exposure, the test mA should be 2.1±0.2mA. If not, adjust R37 on
Filament Driver Board. Remove multimeter and reinstall jumper.
7. Set the multimeter to DC voltage mode. Change and connect the multimeter to TP5 and TP1 (GND) on

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OEC One Mobile C-arm X-ray Product

MCB board. When making an exposure, the test voltage should be 4.0V±0.05V, if not, adjust POT6 on
MCB board.
8. Change and connect the multimeter to TP15 and TP6 (GND) on kVp control board. When making an
exposure, the test voltage should be 4.0V±0.05V, if not, adjust R50 on kVp control board. Check that
DS1 is lit during exposure.
9. Click “Ok” to finish the calibration.
10. Power off the system, then remove the extend board.
11. Restart system. Check the kVp value as the table in section 4.2.1. If they are not in specification, adjust
R50 on kVp control board or go back to step 10.
After the calibration, install the jumper to J46 on extend board.
NOTE

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Calibration

4.2.3 mA Measurement and Accuracy


Perform monoblock warm-up procedure per section 4.5 if monoblock is not powered for
NOTE more than 3 months or monoblock FRU installed. If the FDB board is replaced at the same
time, do not perform monoblock warm-up, but perform following mA measurement and
accuracy check directly.

Make sure to power on system and wait for 5 minutes to perform following mA
NOTE measurement and accuracy check.

1. Remove the rear cover and the cover of the PCB box. Install the MCB board with extend board.
2. Set the multimeter to DC mA mode. Connect multimeter to TP222 (+) and TP210 (-) on extend board.
Remove the J46 jumper on extend board.
3. Power on system. Set the exposure mode and parameter to check to the mA_measure values as
displayed in the form below.The measurement values should be between the minimum and
maximum value. The measured values include mA real value and mA leakage from tube inside as
below:
Exposure mA_real =mA_measure –kVp/800
The error of exposure mA_real value should be within ±10% ranges.
Otherwise, mA calibration procedure should be performed until all the mA_measure values meet the
requirement in the list.
mA_measure Min mA_measure
Exposure mode Exposure mA_set and real value
(mA) Max (mA)
Low Dose Fluoro 2mA@80kVp 1.90 2.30
Normal Fluoro 0.1mA@80KVp 0.19 0.21
4mA@110KVp 3.78 4.54
HLF 6mA@110KVp 5.52 6.75
4.6mA@110KVp(In Dose Group HLF 50) 4.28 5.19
4. mA accuracy of digital spot and HLF of 1PPS 25mA (only in version 2 series system)
Measure the voltage of TP7 (MA-SMP) and TP1 (GND) on MCB board with oscilloscope :
Formula A: Exposure mA_real =Sample Voltage (TP7) (unitV)  1000/400ohm (For power is less than
1320w).
Formula B: Exposure mA_real =Sample Voltage (TP7) (unitV)  1000/200ohm (For power is more than
1320w).
The error of Exposure mA_real value should be within ±10% ranges.

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OEC One Mobile C-arm X-ray Product

Set the exposure mode and parameter to check the voltage (TP7) values listed in the form below. The
voltage of TP7 should be in the range of the form below. Otherwise, mA calibration procedures should
be performed until all the voltage values meet the requirements in the list.

Exposure Exposure Exposure Voltage (Tp7) Voltage (Tp7)


Comments
Mode Ma_set Value Ma_real Value Minimum (V) Maximum (V)
Use formula B. It is
25mA@100kVp, not available in
HLF 25mA@kVp -4.55 -5.45 version 1 series
1PPS
system.
3.2mA@80KVp 6.4mA@80kVp -2.82 -2.30 Use formula A
20mA@110kVp
4mA@110KVp (for 200V/220V/ -4.40 -3.60 Use formula B
Digital
230V/240V)
Spot
10mA@110kVp
4mA@110kVp (for 100/110V/ -4.40 -3.60 Use formula A
120V)
5. mA accuracy in film mode
Film mode is only available in version 1 series system.
NOTE

Measure the voltage of TP7 (MA-SMP) and TP1 (GND) on MCB board with oscilloscope:
mA measured=Sample Voltage (TP7) (unitV)  1000/200ohm
mA real=mA accuracy measure
mA accuracy=[(mA set – mA actual)/mA set]  100%
Set the exposure mode and parameter to check the voltage (TP7) values listed in the form below. For
power input: 100V/110V/120V (Setting in Exposure Management). If the voltage values do not meet
the requirements in the list, redo the calibration.
Exposure Voltage (Tp7) Voltage (Tp7)
kVp and Mas Value Setting Ma Value
Mode Minimum (V) Maximum (V)
40kVp@40mAs 10mA -2.20 -1.80
Film
110kVp@40mAs 10mA -2.20 -1.80

For power input: 200V/220V/230V/240V (Setting in Exposure Management).If the voltage values don’t
meet the requirement in the list, redo the calibration.
Exposure kVp and Mas Value Setting Ma Value Voltage (Tp7) Voltage (Tp7)
Mode Minimum (V) Maximum (V)
40kVp@80mAs 20mA -4.40 -3.60
Film
110kVp@40mAs 20mA -4.40 -3.60

4-8
Calibration

4.2.4 mA Calibration
1. Power off the system. Remove system rear cover.
2. Remove the cover of PCB-box. Install the MCB board with extend board, and install the jumper to J46
on extend board.
3. Power on the system.
4. Enter Admin mode, then click "Calibration" tab, then click “kV & mA Calibration” button.

1. The DC mA mode of the multimeter must be selected before ampere test on extend board.
NOTE 2. You need select the voltage mode of the multimeter before DC voltage test.
3. Provide appropriate X-ray protection on surface of image intensifier in calibration and
verification to protect image intensifier.
5. Set the multimeter to DC voltage mode. Connect multimeter to TP17 (MA-OFF) and TP1 (GND) on MCB
board. The test voltage is 0V, if not adjust POT4 on MCB board.
Change and connect multimeter to TP8 (MA-DIGITAL) and TP1 (GND) on MCB board. The test voltage
about is 0.8±0.05V, if not adjust POT5 on MCB board.
6. Set the multimeter to DC mA mode. Connect multimeter to TP222 (+) and TP210 (-) on extend board.
Remove the J46 jumper on extend board.

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OEC One Mobile C-arm X-ray Product

Short J5 by jumper on MCB board. Take fluoro exposure, the measured mA value should be
2.1±0.05mA, if not adjust R37 on Filament Driver Board, clockwise rotation will increase the current,
and anticlockwise rotation will decrease the current.
When the mA test is finished, install the jumper to J46 and remove the multimeter from TP222 (+) and
TP210 (-).
7. Change and set the multimeter to DC voltage mode. Connect multimeter to TP7 and TP1 (GND) on MCB
board. Take fluoro exposure and check the voltage is -0.8±0.05V, if not, adjust POT7 on MCB board,
anticlockwise rotation will increase the voltage value.
8. Remove jumper on J5 of MCB board. Take fluoro exposure and check the voltage of TP7 on MCB is
-0.8V±0.05V, if not adjust POT5 on MCB board, clockwise rotation will increase the voltage value.
9. Remove jumper J46. Change and set the multimeter to DC mA mode. Connect multimeter to TP222 (+)
and TP210 (-) on extend board. Take fluoro exposure, check the mA value is 2.1±0.05mA, if not adjust
POT7 on MCB board, clockwise rotation will increase the voltage value. Remove multimeter and install
jumper to J46.
10. Click “Ok” to finish the calibration.
11. Power off the system, then remove the extend board.

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Calibration

4.3 Preheat mA Calibration


Provide appropriate X-ray protection on surface of image intensifier in calibration and
NOTE verification to protect image intensifier.

The DC mA mode of the multimeter needs to be selected before mA calibration.


NOTE

1. Install the jumper to J5 on MCB board. Go to service mode and click the "Calibration" tab. Select
“Preheat mA Calibration”. Press footswitch for about 20 minutes until prompt information is displayed
in the monitor.

2. If the footswitch is release before calibration completed, you should press the switch again until
finished. Click “Ok” to finish the calibration. If there is an error, you should redo the mA calibration
procedure from step 1.
If the switch is released, the calibration will start over when switch is re-engaged.
NOTE

3. Make sure the footswitch is released. Remove the jumper from J5. Shutdown the system. Install the
MCB board with extend board, then power on the system. Connect multimeter to extend board

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OEC One Mobile C-arm X-ray Product

TP222(+) and TP 210(-). Make sure that the jumper is removed from J46. Set the condition at 80kVp and
0.1mA and take exposure with fluoro model. The measured current value is 0.20±0.01mA. Otherwise,
adjust POT4 on the MCB board. Clockwise rotation will increase the current. And anticlockwise rotation
will decrease the current.
4. Set the condition at 80kVp, 2mA. Set oscilloscope in trigger mode and the trigger level is - 250mV.
Measure TP7 (MA-SMP) and TP1 (GND) on MCB board with oscilloscope. Take exposure and confirm the
first pulse wave is orthogonal and the mA feedback curve shall be converged within 10ms.
Otherwise, redo the preheat mA calibration. If the curve still can’t be converged within 10ms, slightly
adjust R37 on the filament driven board, refer to section 4.2.3 to confirm the mA accuracy. If the
requirement is not met, redo mA calibration and preheat mA calibration.

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Calibration

4.4 mAs Measurement and Calibration


mAs Measurement and Calibration is only available in version 1 series system.
NOTE

4.4.1 mAs Measurement and Accuracy Check


1. Remove the cover of PCB-box. Remove the MCB board. Install the MCB board with extend board, and
remove the jumper from J46 on extend board.
2. Set the multimeter to DC voltage mode. Connect multimeter to TP222 (+) and TP210 (-) on extend board.
Connect the mAs meter to multimeter meter in series.
3. Take exposure by the parameters below. The error of mAs should be within ±10%. Otherwise, take mAs
calibration according to section 4.4.2.

kVp, mAs Calculation error Minimum (mAs) Maximum (mAs)


40kVp, 40mAs 10% 36 44
60kVp, 20mAs 10% 18 22
80kVp, 10mAs 10% 9 11
110kVp, 1mAs 10% 0.9 1.1

4.4.2 mAs Calibration


The mA mode of the multimeter needs to be selected before mA calibration.
NOTE

1. Adjust mA accuracy in film mode according to step 5 in section 4.3.2 .


2. Take exposure at 80kVp, 20mAs. Adjust expose time by POT2 on MCB board until the measured mAs
value is 20.0mAs±1mAs.
3. Check mAs accuracy according to section 4.4.1.
After the calibration, install the jumper to J46 on extend board.
NOTE

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OEC One Mobile C-arm X-ray Product

4.5 X-ray Generator Warm-Up


This procedure is used to improve the life of the X-ray generator. It is only performed after the generator is
not powered for more than 3 months.
1. Power on the system.
2. Close the collimator iris and place a lead shield in the X-ray beam to protect the image intensifier and
CCD camera.
3. Select the manual fluoroscopy mode. Set the kVp value to 60 kVp@1mA. Take an exposure for 3
minutes.
4. Wait for 5 minutes after exposure.
5. Set the kVp value to 80kVp@1mA and take an exposure for 3 minutes.
6. Wait for 5 minutes.
7. Power off the system.

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Calibration

4.6 Beam Alignment

4.6.1 Camera Centering Check and Calibration


Camera Centering Check
1. Position the C-arm with the image intensifier on top/monoblock on the bottom position. Log in
software service mode, in "Calibration" tab, click “Beam alignment…” button.

2. Open the collimator iris to maximum, perform camera centering check as below.
Roughly (recommend to 1.8LP/mm) adjust camera focus to see the light image margin
NOTE clearly.

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OEC One Mobile C-arm X-ray Product

1. Difference of two reading scales between display mark and light image margin in image
NOTE area 1/3, for system shall be <6 scales of display mark.
2. Difference of two reading scales between display mark and light image margin in image
area 2/4, for system shall be <6 scales of display mark.

3. If the camera centering perform the camera centering calibration can’t meet the specification, check
Camera Centering Calibration.

Camera Centering Calibration


1. Make sure position the C-arm with the image intensifier on top and monoblock on the bottom.
2. Remove the I.I. top cover and then remove the upper counter weight from I.I. upper counter balances.
3. Loosen 3 camera fixed screws.
4. Log in “Beam alignment…” interface if needed
5. Use the 4 camera alignment screws to adjust the camera center. Make sure to unscrew one screw first,
and then fasten the screw on the other side to center camera. Perform camera centering check and
repeat adjusting camera alignment screws as many times as necessary.
6. When the camera centering verification meets the specification, fasten the alignment screws and
camera secure screws.
7. After fastened secure screws, recheck the alignment result. If fail, redo calibration.

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Calibration

4.6.2 Collimator Centering Accuracy and Calibration


1. Position the C-arm with image intensifier on top and monoblock on the bottom.
2. Log in software service mode, in "Calibration" tab, click "Beam alignment…" button.

3. Take exposure in normal fluoro and ABS mode, open/close the iris slowly and continuously to show the
iris near circular mask and verify that the iris leaves are shown as balanced along the circular mask
around all angles.
The distance between leaf_1/2/3/4 and circular mask shall equal to the distance between opposite
leaf_5/6/7/8 and circular mask, and tolerance of two scales is ≤4 scales of display mark.

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OEC One Mobile C-arm X-ray Product

4. If not aligned, open the collimator cover, loosen the set screws (2 pieces), and adjust the collimator iris
alignment screws (2 pieces) to center the collimator on the BAFT (Use the BAFT image to determine the
direction to shift the collimator iris). Repeat steps 4 and 5 to center the collimator.
5. Fasten the set screws of collimator.
Cleanup
1. After completing collimator iris centering calibration, make sure to tighten all collimator iris fixed
screws.
2. Take exposure in normal fluoro and ABS mode. Recheck the calibration result, if failed, redo the
calibration.
3. Assemble the collimator cover.
4. Remove the BAFT/UBAT tool from the image intensifier.

4.7 BAFT/UBAT Installation and Alignment


1. Position the C-arm with monoblock on top and image intensifier on the bottom.
2. Make sure that the tool was locked tightly to the I.I..
3. Align the BAF tool and UBA tool center with image display center.

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Calibration

4.8 I.I. Field Size Check and Calibration


I.I. Field Size Check
1. Select relative field size, open the collimator iris to the maximum, and take an exposure.
2. Read the BAFT/UBAT tick mark on the boundary of the image. The size of the image should be within
the range of the values below.

Mag Mode NORM MAG1 MAG2


Displayed Image Diameter (mm) 210 ±10 155 ±8 115 ±8
3. If the size of the image is out of requirement, I.I. field size calibration shall be performed.

I.I. Field Size Calibration


I.I. size adjustment is done in the I.I. factory. Adjust with much care only if the power supply
NOTE is changed or repaired. Always use non-metal flathead screwdriver to adjust the I.I.
potentiometer to avoid short circuit.
1. Open the I.I. potentiometer cover, and carefully adjust the I.I. field size by potentiometer A.
2. Take an exposure, and check the resolution again. Repeat it as necessary.
3. Put the I.I. potentiometer cover back.
4. Take an exposure, and check the field size, repeat as many times as necessary as field size is in
specification.
Cleanup
1. After the procedure is successful, remove the BAFT/UBAT.
2. Assemble the I.I. potentiometer cover.

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OEC One Mobile C-arm X-ray Product

4.9 Collimator Check and Calibration


Collimator Preview Check
In application interface, perform the procedures listed below to check the collimator status.
1. Refer to Section 4.7 to install BAFT/UBAT on the I.I. Set the exposure into the normal fluoro and ABS
mode, then take an exposure. Adjust the BAFT to make sure the BAFT center match the mark center
(deviation≤3mm).

1. For complete version 01.02-01 system, refer to Section 5.2.5 Imaging Config and
NOTE
enable "Display Mark" in order to display the mark center in the image. Make sure to
disable "Display Mark" after beam alignment.

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Calibration

2. For complete version 01.03-01 system and later, refer to step 3 in Section 3.6.5 System
Configuration in User Setup Interface and enable "Display Mark" in order to display the mark
center in the image. Make sure to disable "Display Mark" after beam alignment.

After installation, please pay attention to BAFT/UBAT to prevent it falling when rotating
NOTE C-arm. Rotate BAFT/UBAT to adjust angles when the BAFT/UBAT values are not
appropriate.
2. Set the system in auto technique mode and auto rightness/contrast mode. When take an exposure,
check the accuracy of collimator preview below.
a. Switch the I.I. between normal, Mag1, and Mag2 mode. Under each mode, make sure the leaves of iris
or shutter are out of image. (Except for the countries with special regulation, eg. Germany).
b. Minimum position of iris/shutter is in 50mm  50mm square of BAFT/UBAT.
c. Press the Close/Open/Rotation (for shutter) button from maximum to minimum to check the preview
line moves smoothly or not. Randomly select a position, record the preview line, and then take a fluoro
exposure, the difference between preview line and real iris/shutter leaves should be less than15mm/
10degree (for shutter rotation).
3. If system can not pass the check, perform the collimator calibration again.

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OEC One Mobile C-arm X-ray Product

Collimator Calibration:
Position the C-arm with image intensifier on top and monoblock on the bottom.
Login Administration interface with service authority. In "Calibration" tab, click “Collimator Calibration”
button and follow the calibration wizard to do collimator calibration.
Please strictly follow below procedures as shown below to perform collimator calibration.In
NOTE steps 2/3/4/7/8/9 iris/shutter should be adjusted until the leaves are just out of circular
mask (during exposure), according to the calibration wizard, then fill in reading value.

Step1 Collimator Calibration Initializtion:


Comments: shutter/iris limitation position calibration.
Step2 Calibrate iris maximum position for Normal mode (Move iris until the leaves are just out of the
circular mask).
Step 3 Calibrate iris maximum position for Mag1 (Adjusted way refer to step2. Move iris until the leaves
are just out of the circular mask).

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Calibration

Step 4 Calibrate iris maximum position for Mag2 (Adjusted way refer to step2. Move iris until the leaves
are just out of the circular mask).
Step 5 Calibrate iris position between 60mm and 65mm.
Step 6 Calibrate iris position into 50mm  50mm square.
Step 7 Calibrate shutter maximum position for Normal mode (Move shutter until the leaves are just out
of the circular mask).
Comments: Measure method is same as iris diameter measure method.
Step 8 Calibrate shutter maximum position for Mag1 (Move shutter until the leaves are just out of the
circular mask).
Step 9 Calibrate shutter maximum position for Mag2 (Move shutter until the leaves are just out of the
circular mask).
Step 10 Shutter position for 50mm  50mm square.
Comments: Rotate shutter to make shutter leaves parallel with the side of 50mm  50mm square. And let
the shutter leave back shade cover the line of 50mm  50mm square.
Step 11 Normal mode diameter of circular mask.
Step 12 Mag 1 diameter of circular mask.
Step 13: Mag 2 diameter of circular mask.
Step 14 Collimator calibration successfully completed.
1. If any regulatory body or user requires that the collimator be visible in the image, the
NOTE service engineer could select “The collimator iris is required to be visible in FOV” to
calibrate it.
2. German regulations require that the collimator must be visible on two sides of the image,
which are not opposite. For the systems installed in Germany, adjust the collimator iris
until the leaves are visible as pictured below.

3. Australia regulations require that the beam limiting device must automatically limit the
primary beam to X-ray image receptor area (within 1% SID), which it must set to the
selected field of the I.I. or image receptor in the fluoroscopic mode. For the systems
installed in Australia, adjust collimator iris until the collimator 8 leaves can be seen in the
image.

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OEC One Mobile C-arm X-ray Product

4.10 ABS Tracking Check and Adjustment


ABS Tracking Check
1. Make sure that X-ray tube cover is installed.
2. Position the C-arm with I.I. above the X-ray tube.
3. Select auto fluoroscopy mode, and the normal field size to take an exposure. Put the 1mm, 2mm, and
3mm copper sheet respectively on the tube head.
4. Verify that the kVp stabilizes in the specified range below for each copper filter thickness:

Copper Filter Thickness 1mm 2mm 3mm


kVp range 64±4kVp 74±4kVp 82±4kVp

5. If the ABS tracking check fails, perform kVp accuracy check. If kVp accuracy check passes, perform
entrance dose rate check and camera iris adjustment as shown below.
Entrance Dose Rate Check and Camera Iris Adjustment

Camera iris adjustment is done in the factory. Adjust only if necessary and with much care.
NOTE

1. Place the dosimeter probe on the I.I. grid center, and secure it with transparent tape.

2. Use 2mm copper sheet to cover the beam path on the X-ray tube, and secure it with tape.
3. Position the C-arm to lateral position.
4. Take an exposure in auto fluoroscopy, and wait until the technique stabilizes. Check if the dose rate is
within:
4.1±0.3mR/min (35.92±2.63uGy/min or 2155±157uGy/hr)

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Calibration

If procedure fails, open the camera head cover, and carefully adjust the camera iris. Loosen camera
iris fixed screw, turn camera iris to smaller index to decrease the stable dose rate, and to bigger index
to increase stable dose rate.
Don’t touch the iris internal fixed screw which might disable the iris adjustment ring.
NOTE

5. Take an exposure to make sure the entrance dose rate. meet the requirements:
4.1±0.3mR/min (35.92±2.63uGy/min or 2155±157uGy/hr)
6. If many trials fail, check the kVp and mA calibration, and come back to camera iris adjustment. Repeat
as many times as necessary.
7. When it passes, check if the kVp is within specification of ABS tracking check. If not, perform kVp and
mA check, and return back to the camera iris adjustment.
8. When it passes, fix the iris by tightening the camera iris fixed screw. Remove the dosimeter probe from
the I.I., remove copper sheet from the X-ray tube, and perform ABS tracking check.
Cleanup
When you follow the normal beam alignment procedure, at this stage if you need to access the camera
head for camera focus adjustment, you do not need to reassemble the camera head cover.

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OEC One Mobile C-arm X-ray Product

4.11 Image Resolution Check


Image Resolution Setup
1. Position the C-arm with I.I. above the X-ray tube.
2. Create a new exam with the default settings.
3. Place a spatial resolution tool on the image intensifier, and
secure it with transparent tape.The angle between the
horizontal axis of the image and the spatial resolution tool
shall be around 45 degrees as pictured to the right.
4. Select auto fluoroscopy mode. Take an exposure, and stop
when image is stable. Adjust kVp and mA if necessary.
5. Read the Image resolution on the display image. It is the
maximum number (lp/mm) where half of the lines are
distinguishable. Adjust brightness and contrast to get high
image quality.
6. Verify if the resolution is within the specified value range
below.

Field Size NORM MAG1 MAG2

Resolution (Lp/mm) ≥ 2.2 ≥ 2.8 ≥ 3.3


7. Repeat step 2 to step 6 for MAG1 mode.
8. Repeat step 2 to step 6 for MAG2 mode.
9. If the resolution check fails, adjust the camera focus, refer to section 4.12.

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Calibration

4.12 Camera Focus Calibration


Camera focus adjustment is done in the factory. Adjust only if necessary and with much
NOTE care.

1. To have access to CCD camera focus, perform the following:


a.Turn off the power.
b.Position the C-arm to lateral position.
c.Remove I.I. top cover.
d.Remove counter weight.
e.Power on the system.
2. Loosen camera focus fixed screw, adjustment camera focus.
3. Take an exposure, and check the resolution again. Repeat as many times as necessary.
4. If passed:
a.Tighten the camera focus fixed screw.
b.Power off system.
c.Install counter weight.
d.Install I.I. top cover.
5. If the resolution check fails after many trials, make I.I. focus adjustment, refer to section 4.13.

4.13 Image Intensifier Focus Calibration


I.I. focus adjustment is done in the I.I. factory. Adjust with much care only if the power
NOTE supply is changed or repaired. Always use non-metal flathead screwdriver to adjust the I.I.
potentiometer to avoid short circuit.
1. Open the I.I. potentiometer cover, and carefully adjust the I.I. focus POT.
2. Take an exposure, and check the resolution again. Repeat as many times as necessary.
3. If not, check I.I. size again.
4. Put the I.I. potentiometer cover back.
Cleanup
1. After calibration completed, remove the resolution tool from the I.I. grid.

2. Power off the system.

3. Reinstall the I. I. potentiometer cover.

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OEC One Mobile C-arm X-ray Product

4.14 Dose Accuracy Check and DAP Calibration

4.14.1 DAP Calibration Check


1. Dose Rate Accuracy Check
a. Create a new exam. Make sure the collimator iris is open to maximum.
b. Put detector of dosimeter on the I.I. surface in the beam axis. Take an exposure in auto mode, observe
and adjust the dosimeter detector to the center of I.I. set dosimeter to dose rate in Gy/min.
c. Set the exposure modes and parameters listed below, take an exposure, when the reading of
dosimeter is stable, record the dose rate displayed on the monitor and record the dose rate displayed
on dosimeter into below column. Calculate and record deviation as follow.
Monitor displayed Dose Rate
Deviation =  ----------------------------------------------------------------------  0.49 – 1  100%
Measured Dose Rate

Monitor Displayed Deviation


Measured Dose Rate
Mode kVp mA Dose Rate (Pass criteria
(mGy/min)
(mGy/min) <25%)
Normal 45 2

2. Dose Accuracy Check


a. Fix dosimeter detector on the center of I.I. surface.

b. Set dosimeter to accumulated dose in Gy and reset dosimeter to zero.

c. Create a new exam. Record the dose value displayed on monitor into the column of dose on monitor
before exposure. Set the exposure modes and parameters listed below. Take an exposure and hold on
for 5~10s then stop exposure. Record the dose displayed on the monitor into column of dose on
monitor after exposure, and record the dose displayed on dosimeter into column of measured dose of
dose meter. Calculate estimated dose in column displayed dose increment.
Displayed Dose Increment = Dose on monitor after exposure – Dose on monitor before exposure

d. Calculate and record deviation as follow.


Displayed Dose Increment
Deviation =  -------------------------------------------------------------------------  0.49 – 1  100%
 Measured Dose of dose meter 

Mode kVp mA Dose on Dose on Displayed Dose Measured dose Deviation


monitor before monitor after Increment of dose meter (Pass
exposure (mGy) exposure (mGy) (mGy) (mGy) criteria
<25%)
4pps 80 2.1

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Calibration

3. DAP Accuracy Check


a. Position C-arm to AP position, the monoblock is at the bottom and I.I. is at the top.
b. Create a new exam.
c. Install BAFT/UBAT on I.I.. Set the Mag mode to Mag2. Take an exposure in auto fluoro mode and hold
on. Close iris a little by pressing the iris collimator close button on tablet control panel until at least
two opposite leaves are visible on monitor. Then stop exposure. Read the distance on BAFT between
any pair of opposite leaves. Record the value in column diameter. The unit should be mm. Refer to the
above manner to measure the diameter of Mag1 and Normal mode. Remove BAFT from I.I..
The semi-transparent part of leaves shall be considered. The measurement shall start and
NOTE end at the middle of semi-transparent area.

d. Fix dosimeter detector on I.I. surface. Take an exposure in auto fluoro mode, observe and adjust the
dosimeter detector to the center of I.I. surface. Set up the dosimeter to accumulated dose in Gy and
reset dosimeter.
e. Set the kVp/mA and exposure mode as the parameters in table shown below and do measurement
in sequence. For each measurement, record the DAP displayed on monitor into column DAP on
monitor before exposure, then take an exposure for at least 20 seconds. After exposure finishes,
record the DAP displayed on monitor in column DAP. Record the measured dose of dosimeter in
column "Measured dose of dose meter". Reset the dosimeter after each measurement is done.
f. Calculate and fill DAP estimated in column DAP estimated.
DAP increment on monitor = DAP on monitor after exposure – DAP on monitor before exposure

g. Calculate and record deviation as follow.


DAP increment on monitor  100000
Deviation =  ------------------------------------------------------------------------------------------------------------------------------------2- – 1  100 %
 
Measured dose of dose meter  0.8285  Diameter

h. Repeat step c) ~step g) to measure and record the DAP deviation of Mag1 and Normal.

Measured DAP on DAP on Deviation


DAP
dose of monitor monitor (Pass
Diameter increment on
Mode kVp mA Mag dose before after criteria
(mm) monitor
meter exposure exposure
(Gy.cm2) <25%)
(mGy) (Gy.cm2) (Gy.cm2)
Normal
105 3.6 Mag2
Fluoro
4PPS 80 2.1 Mag1
Normal
45 2 Normal
Fluoro

1. If system can not pass the check, perform the collimator calibration and DAP calibration,
NOTE then perform this check again, until system passes the check.
2. Among the three numbers in the Deviation column, choose the worst one.

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OEC One Mobile C-arm X-ray Product

4.14.2 DAP Calibration


1. Login “Administration” interface by Service authority, select “Calibration” tab. The “DAP Calibration
with/without Filter” button is displayed on screen. When DAP calibration has been performed, the
calibration time will be shown beside the “DAP Calibration with/without Filter” button.

2. Make sure “Beam Alignment…” has been performed so that the system can work in normal mode and
the I.I. grid is located at the center of X-ray beam.
3. Position the sensor of dosimeter on the center of I.I. grid cover.
4. Click the “DAP Calibration with/without Filter” button to enter calibration screen.
5. When the DAP calibration popup window is displayed, click the “Help” button to get detailed
procedures on DAP calibration. Then follow the instructions on the prompt to finish DAP calibration
step by step.

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Calibration

1. kVp/mA will be set automatically after clicking on each target kVp/mA.


NOTE
2. For each kVp/mA group, take exposure for at least 5 seconds. Observe the dose rate value
until the reading is stable and then record the dosimeter reading of dose rate.

6. After finishing all measurement cases, click the “Calculate” button.


7. If calibration errors (%) in all cases are within the permitted tolerance, calibration errors will be
calculated automatically and shown on the error column.
8. Click the “Finish” button. The calibration data will be updated. Then click “OK” to finish DAP Calibration.
9. If calibration error of one or more cases exceed the permitted tolerance or errors occur during DAP
calibration, a warning message below will be shown when clicking the “Calculate” button on the
screen.
10. Click the “OK” button, the following message box will pop up, redo the calibration (refer to steps 5 to 8).

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OEC One Mobile C-arm X-ray Product

4.15 Uniformity Calibration


1. Login administration interface by service authority, select the “Calibration” tab, then click “Uniformity
Calibration…” button.

Before calibration, make sure there is no object in the X-ray field, and the C-arm position is in
C A U T IO N the up-down position with I.I. vertically above the tube.

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Calibration

2. The uniformity calibration needs three exposures, follow the three steps below to complete the
calibration.
Step 1

Step 2

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OEC One Mobile C-arm X-ray Product

Step 3

4-34
Calibration

3. Uniformity calibration successfully is successful. Then click the “OK” button.

4.16 Monitor Brightness and Contrast Adjustment


4.16.1 Keys assignment and operation LED
Remove rear access panel on monitor. When facing the screen of the monitor, the keys from left to right are
“Exit”, “Minus”, “Plus” and “Menu” respectively.

A “dynamic help for keypad function” is available for each menu. It explains the role of each Key on the OSD
menu window, which is currently active.

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OEC One Mobile C-arm X-ray Product

4.16.2 Lock and unlock the OSD menu

Action Key sequence


Press Exit key once and Plus key three times in 3
Unlock OSD menu
seconds, when keys are locked.
Lock OSD menu When exit menu, it can be auto locked.

4.16.3 Key Functions in the OSD Menu

Key(s) Situation Action


Menu Always Select / Confirm
Slide controller Increase value
Plus
Selection point Next menu item
Slide controller Decrease value
Minus
Selection point Previous menu item
Exit Always Return to higher level menu

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Calibration

4.16.4 Brightness and Contrast Adjustment

The monitor is calibrated in factory. It is not recommended to change the contrast value, if
NOTE so optimized LUT settings will be changed and some of the image information may be lost.
It is suggested to only adjust the backlight of the monitor if the luminance is not acceptable.

Function Adjustment range Description


Adjustment of contrast
This allows the brighter area to be seen more distinctly.
Contrast 1…100
The center point is 50.
Note: Manual changes of contrast are not recommended.
Brightness 1…100 Brightness adjustment of LCD backlight.

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OEC One Mobile C-arm X-ray Product

4.16.5 Colour Temperature Selection

mmmmmmm

There are 3 options provided. Default color temperature is 8,000K. A service engineer can change color
temperature as per user’s request.

4.16.6 Calibration Curve Selection


GAMMA2.2 and DICOM calibration curves are provided. GAMMA2.2 is default option.
1. For monitor Rev 1, the setting screen is as the picture below.

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Calibration

2. For monitor Rev 2, the setting screen is shown as the picture below.

Configuring the LUT setting refers to local regulations and the following LUT setting
NOTE reference.
If the ambient illuminance is unclear, it is suggested to select DICOM_ILL300 as default.

LUT Setting Reference

LUT Setting Ambient Illuminance

DICOM_ILL0 0-100 lux

DICOM_ILL300 100-300 lux

DICOM_ILL500 300-500 lux

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OEC One Mobile C-arm X-ray Product

4.16.7 Check and Configure Software UI


For countries and regions that need to meet DIN 6868-157 requirements such as Germany
NOTE and etc, follow the instruction as below.

1. Check the monitor version and make sure that it is version 2.

2. Access to Administration UI to make sure “Gamma to DICOM” is checked,

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Calibration

3. Access to Setup screen make sure “Test Patterns…” is enabled, the detailed instruction please refer to
section 11.7 Maintenance in Operator Manual.

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OEC One Mobile C-arm X-ray Product

4.16.8 Information and Input Source

Firmware version and working hours of monitor are shown in information menu. Input source shows which
input video source is used.

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Calibration

4.16.9 Restore Factory Settings

Service engineer can use this menu item to restore all settings to factory preset values.

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OEC One Mobile C-arm X-ray Product

4-44
Chapter 5 Software
OEC One Mobile C-arm X-ray Product

5.1 Overview
This chapter will describe how to use the service tool and the procedure of software upgrade and
installation.
The OEC One series products include two system serial number and two release versions software in
customer site.
The serial number BB6SS*******HL is indicated in the system rating plate and this series products’ software
release version is “Release version: 1".
The serial number BB6SV*******HL is indicated in the rating plate and this series products’ software release
version is “Release version: 2". These series products provide optional vascular imaging, dynamic recording
function and wireless footswitch, but it is not available for film mode.
The “*” in the system serial number is number which varies from 0-9 and represents manufacturing year
and number, there are 7 numbers in total.
To simplify the description, “Version 1" represents BB6SS*******HL series products and “Version 2"
represents BB6SV*******HL series products in this manual.
This service manual supports both series system for service, but some of the functions are available based
on which configuration the customer has purchased.

5.1.1 General Description


OEC One Mobile C-arm X-ray Product provides service tools within included software for the use of the
service engineer.Using the service tool, service engineers can:
• Get system information and set system ID
• Configure product model and options
• Configure exposure management parameters
• Configure image processing parameters
• Maintain the System
• View the System log

5.1.2 Software Version Compatibility Matrix


1. Complete version is equivalent to the system version, which is used for recording version information
during installation and PM (Periodic Maintenance).
2. Each complete version has four corresponding sub-versions as shown in the following Version
Compatibility Matrix.

5-2
Software

3. When updating the software, FSE needs to make sure that the sub-version matches its corresponding
complete version as shown in the following Version Compatibility Matrix. Otherwise, it may cause
system incompatibility.

Table 5-1 Software/Firmware Version Compatibility Matrix


Workstation Mainframe Tablet Main Change
Software Complete Software Version Software Version Hardware Software
Release Version (MCU) Information Version
Version (CPLD)

1 01.02-01 01.02.00.00-01 01.00.00.S-01 01-S 01.00.00-01

1 01.03-01 01.03.01.00-01 01.01.01.S-01 01-S 01.01.00-01 Meet DIN 6868-157, but need
monitor Rev 2.
2 02.01-01 02.01.02.01-01 02.01.02.V-01 01-V 02.00.01-01 1. New feature:
Dynamic Recording
Vascular
GESAK
2. Don’t support film.

5.1.3 Service mode access control and GESAK

The GE Service Access Key (GESAK) USB stick is the service authentication mechanism which is used to
authorize access to the Service mode. Screens for the General User and Admin do not require a GESAK.
The GESAK is configured to limit access to certain system(s) and/or to expire periodically. Additionally,
access to service features which provide a service efficiency improvement or which are proprietary to
GEHC are limited by the level defined on the GESAK.
The Gesak.zip file must be in the root directory of a USB stick, be left compressed, and be
NOTE
named exactly Gesak.zip, for the system to recognize it.
Customer level GESAKs are assigned to specific system identifiers. If the system displays a
NOTE
message that the Service Access Key is not valid for this system, then check that GESAK is
valid for this system serial number or type of system.
The system will recognize a GESAK with FAT16, FAT32 or extN file system formats.
NOTE

The GESAK should be unmounted before it is removed from the system, otherwise, data
C A U T IO N
corruption on the GESAK could occur. All USB sticks are automatically unmounted when
exiting the service mode.

5-3
OEC One Mobile C-arm X-ray Product

5.2 Service Mode


After OEC One system has booted up successfully, enter Administration screen (Service mode).
For version 1 series system:
Method 1. Enter Admin mode by “Setup screen” -> “Maintenance” -> “Login Administration”. Click the “Yes”
button to access Admin login screen. Select "Service" as user by clicking drop down list button, input service
authority password. Click the “Login” button, access the Administration screen.
Method 2. Use the USB external keyboard and press down "Ctrl", "Shift", "Alt" and "→" keys together, then
the administration interface can be invoked. Select "Service" as user by clicking drop down list button, input
service authority password. Click the “Login” button, access the Administration screen.
For version 2 series system:
After the GE Service Access Key (GESAK) USB stick is plugged in, a confirm message will be displayed on the
monitor, then click “Yes” button to access Administration screen. For the detailed information about GE
Service Access Key (GESAK), refer to Section 5.1.
All settings in service tool can be activated.
NOTE

5.2.1 System Information


• “System Information” tab including:
Host ID
Serial Number
System ID
Release Version
Complete Version
• Workstation Information:
Hardware Information
Software Version
• Mainframe Information:
Hardware Information
Software Version
• Tablet:
Software Version
• Usage Statistics:
Performed Exam Number
Scheduled Exam Number
Saved Image Number
About system ID set or upgrade:
The system ID will be set up as blank during manufacturing. Field engineer shall set actual system ID during
installation and make sure it’s the same as the SID in service record system.

5-4
Software

Field engineer can set or change system ID of the system. Current system ID is displayed on the screen
automatically. Fill in the new system ID in the text box and restart system.

5.2.2 Product Config


Activate software option feature by typing:
Input option name into Area_1 and input option license key into Area_2. Click the “Add” button in software
option area.
Activate software option feature from USB disk:
Insert USB disk with license file into USB port. Click the “Medium” drop down list button to select
corresponding sub-area and license file, click the “OK” button.
Hardware Configuration:
Filter Option: Disable/Enable removable filter option.

5.2.3 Calibration
For detailed calibration instruction, refer to chapter 4 Calibration.

5.2.4 Exposure Config


For configurate exposure config, refer to step 4 in Section 3.6.4. Click here to jump to the Section 3.6.4 step 4.

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OEC One Mobile C-arm X-ray Product

5.2.5 Imaging Config


System provides tool to set imaging parameters. Click “Image Processing Configure” tab on the main screen, the
image processing interface is displayed.
Changes on Image Brightness, Image Contrast, Black/White Margin and Sharpen power are
NOTE not recommended because these existing values have been designed to provide the clearest
and most realistic anatomical imaging possible. Any changes will affect the system image
quality.
• Image Brightness: Clicking the arrow allows you to adjust image brightness value from 0 to 100.
• Image Contrast: Clicking the arrow allows you to adjust image contrast value from 0 to 100.
• TNR (Temporal Noise Reduction): Clicking the drop down list button allows you to adjust noise filter
value from 0-3.
• Smart Metal: Clicking the arrow allows you to adjust smart metal value in the image from 0-50.
• Edge Enhance: Clicking the drop down list button allows you to adjust edge enhance value from 0-9.
• Rotation Angle: Clicking the arrow allows you to adjust rotation angle value from 0-359.
• Black/White Margin: This adjustment should be made very carefully only when necessary, as it may
affect the overall image quality. Clicking the arrow allows you to adjust image margin value from 0 to
10,000. Increasing White Margin value may decrease the overall contrast and brightness, and
increasing Black Margin value may decrease the overall contrast and increase the brightness.
• Circular Mask: it is used to assist beam alignment calibration. Make sure it is set back to the default
setting “Enable” after beam alignment.
• Display Mark: it is used to assist beam alignment calibration. Make sure it is set back to the default
setting “Disable” after beam alignment. For version 01.03-01 system and later, this feature is moved
to "C-Arm System" on Setup.
• Shading: it is used to assist the shading correction calibration. Make sure it is set back to the default
setting “Enable” after shading correction calibration.

5-6
Software

5.2.6 Maintenance
Export/Import System Setup:
Export/Import System Setup configuration file by USB.
Export/Import Administration Config:
Export/Import Administration Config configuration file by USB.
Recommend export both files before upgrading system software and import after upgrading.
Export/Import Mainframe Calibration Data:
Export/Import Calibration Data file of MCB board by USB.
File data includes kV&mA Calibration, Preheat mA Calibration, Beam Alignment, Collimator Calibration, DAP
Calibration with Filter and DAP Calibration without Filter.
Backup/Restore Database:
Backup/Restore Database for/from database pool.
Backup the current database file on this screen. The database file contains patient and exam information.
Click the “Backup” button to save the current database file. A double confirm screen will display. Click the
“Yes” button to start backup. The process will complete and “Backup database successful.” message
displays. Click the “OK” button to exit the screen. There are two backup files in the system.
Click the “Restore…” button to enter the “Select Backup Database” screen. The backup files’ names contain
the time stamp. You can choose a database according to the time. Click the “OK” button, then click the “Yes”
button on the monitor to start the restore process. The restore will complete and “Restore database
successful.” message displays, then click the “OK” button to exit the screen.
Upgrade Software:
The software upgrade includes: Workstation upgrade, Mainframe upgrade, Tablet upgrade.
Detailed software upgrade procedure refers to section 5.3.
Reset Admin Password:
This feature is to reset Admin password to original.
Data Integrity Check:
The consistency check function is to compare the database and image files. Click the “Data Integrity
Check” button on main screen to enter this screen.
Click the “Check” button on the screen, then click the “Yes” button on confirmation screen to start the check
process. The result will be displayed on the frame after the process completes.
Reset Quality Control Password:
Click the “Reset Quality Control Password” button to reset the quality control password.
Format Cine Disk:
The format cine disk function is available in release version 2 and later, which is used to format the cine
disk on the OEC One system. Click "Format Cine Disk" button on the screen to format disk.

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OEC One Mobile C-arm X-ray Product

5.2.7 Log Viewer


Log Viewer screen allows service engineer to review the system log, including system events and detailed
information of errors, warnings and information messages, for detailed event code explanation.
Click “Log Viewer” Tab on main screen:
Date: Used to select the time period to view. You can search the logs created in the selected period. The
available options are: ALL, Today, last 2 Days, last 3 Days, last 7 Days, last 30 Days.
Type: Select the log type.
The available options are: ALL, ERROR, WARNING, EXCEPTION OR EVENT.
Sub-system: Search the log information software according to sub-system in the event of system failure.
The available options are: APPLICATION, IMAGING, INFRASTRUCTURE, XRAYCONTROL, TABLET and ALL.
Search for: Input the key words of the log text in the textbox to search.
Exception Code: Input the error code displayed on the monitor to search the log.
Module: Search the log information according to module where the event or failure occurred. The available
options are: ADMINISTRATION, ANNOTATION…...
Search Button: Click the button to start the search operation and invoke detailed log information.
Log Information Area: Display the search results of the log. This field will show the User, Time, Module,
Exception ID and log text of the log.
Reset Button: Click the “Reset” button to clear all selected search option and restore to defaults.
Export Button: Click the “Export” button to export log files to USB disk which is selected in “Medium” click
drop down list. The export will complete with a message “Export log file is done.”. Then click the “OK” button.
All log files will be exported into one *.zip file named with system S/N and exported date/time. Extract the
file with password (same as login service tool). System log will be divided into small files after exported.

5-8
Software

5.3 Software Installation and Upgrade


There is one software installation disk for OEC One C-arm X-ray Product.
The DVD disk includes Workstation, Mainframe and Tablet software. The three-unit’s software can be
upgraded by the DVD disk.
1. Setting and configuration backup/restore:
NOTE
System provides user settings, administration settings, and backup/restore features.
Before installing software, backing up all settings and configuration is recommended. For
details, please refer to section 5.2.6. Backup the e-license by referring to section 5.2.2.
2. Software installation needs:
USB keyboard.
USB CD/DVD Rom part number 5075511.
Software installation DVD disk part number 5767632.
3. Upgrade software in the order shown in the picture below.
4. Updating the software needs to follow Version Compatibility Matrix in section 5.1.2.
Otherwise, it may cause system incompatibility.

3 2 1

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OEC One Mobile C-arm X-ray Product

5-10
Chapter 6 Troubleshooting

OEC One Mobile C-arm X-ray Product

6.1 Overview

This chapter describes messages that appear on the monitor and tablet control panel during system
operation.
Messages may indicate any of the following:

• Error Messages
• Warning Messages

6.2 Error Recovery Steps


Perform the following error recovery procedures if you encounter problems during start-up or operation:
1. Some messages can be cleared by pressing OK button or taking exposure, but will periodically re-
display while the condition exists.
2. If an error message occurs shutdown the system. Wait one minute, and then press the power on key.
If this fails to restore normal operation then proceed with step 3.
3. Press the power off key, disconnect the power cord, and call for service. Refer to chapter 1 for
communication center telephone numbers. Do not continue using the system.

System may fail at any time. Ignoring error and warning messages may result in equipment
WARNING damage and personal injury.

6-2
Troubleshooting

6.3 Troubleshooting Guide


6.3.1 System Boot up Display
Monitor Screen:

Tablet Control Panel:

Normal Boot up time is about 1’30".

6-3

OEC One Mobile C-arm X-ray Product

6.3.2 System Shut Down Display


Monitor Screen:

Tablet Control Panel:

Shut down time is about 30".

6-4
Chapter 7 Replacement
OEC One Mobile C-arm X-ray Product

7.1 FRU list

Item Part Number Description Q’ty Comments


1-1 6888800-1 PWA, Mainframe Control Board 1 Only for version 1 series
system

1-2 Only for version 2 series


6888800-2 PWA, Mainframe Control Board 1
system
2 6888807 PWA, Updown Board 1
3 6888805-1 PWA, System Interface Board 1
4 6888819 PWA, Video Distributor 1
5 6888806-1 PWA, Power Management Unit 1
6 5085609 PWA, Extended Board 1 Tool
7 5085603 PWA, Collimator Control Board 1
8 5085604 PWA, Filament Drive Board 1
9 5085610 PWA, KV Control Board 1
10 5085601 PWA, Mother Board 1
11 5085004 ASM, Generator, Monoblock 2.2A 1
12 5331600 MISC, System and HV Power Filter 1
13 5329278 MISC, DC Bus Capacitor 1
14 6888886 MISC, DC Bus Fuse 1
15 5885786 MISC, Exposure Indicator 1
16 5329281 MISC, Resonant Capacitor 1
17 5085800 MISC, DC Power Supply +5V,+15V,-15V 1
18 5085801 MISC, DC Power Supply +5V, +12V AND 1
19 5329275 MISC, Rectifier Bridge 1
21 5885855 Battery Pack, 12V, 7.0Ah 2
22 6888790 Up and Down Button with Cable 2
23 6888727 Power On/Off Button with Cable 1
24 6888730 Monitor Cable 1
25 6888700 Bundle Cable 1
26 6888885 Breaker for 110V,20A 1
27 6888880 Breaker for 220V,12A 1
28 5885852 Breaker for 110V,10A 1
30 5407037 Cable with Plug_ AFSNIT 107-2-D1 1
31 5407042 Cable with Plug_ AS/NZS 3112 1
32 5407045 Cable with Plug_ IRAM 2073 1

7-2
Replacement

Item Part Number Description Q’ty Comments


33 5407039 Cable with plug_ NBR 14136 1
34 5408318 Cable with Plug_ NEMA 5-15P 1
35 5407035 Cable with Plug_ NEMA 5-20P 1
36 5407036 Cable with Plug_L6-20P 1
37 5407050 Cable with Plug_ SI-32 1
38 5407033 Cable, Power Cable with BS1363A 1
39 5407032 Cable, Power Cable with BS546 1
40 5407031 Cable, Power Cable with CEE77 1
41 5408320 Cable, Power Cable with GB1002 1
42 5407038 Cable, 110V Power Cable with NEMA5- 1
15
43 5407048 Cable, Power Cable with SEV1011 1
44 5075919 FRU, Fuse Kit 1
45 5075790 Cable, Monoblock Test Jig 1 Tool
46 Computer, Solid State Drive for Cine Only for version 2 series
9888961 1
Option system
47 5999026 Computer Power Supply 1
48 6888963 Computer, LAN Card Suite 1
49 5085509 Computer, Hard Disk 1
50-1 6888966 Computer, Mainboard Assembly 1 Only for version 1 series
system

50-2 Only for version 2 series


9888966 Computer, Mainboard Assembly 1
system
51-1 6888965 Computer, Memory Bank, 2GB 1 Only for version 1 series
system
51-2 Only for version 2 series
9888965 Computer, Memory Bank, 4GB 1
system
52 6888964 Computer, Display Card 1
53 7491850 ASM, Camera 1
54 5075967 ASM, 9” Image Intensifier 1

7-3
OEC One Mobile C-arm X-ray Product

Item Part Number Description Q’ty Comments


55-1 5075505 Grid 1 Only for version 1 series
system.

55-2 Only for version 2 series


5330066 Grid 1
system.
56 5085918 I.I. Power Supply 1
57 6888902 Tablet, 10.1” 1
58 6888905 Color LCD Monitor and Cover, 27” 1
60-1 5767632 OEC One System Software DVD 1 Only for version 1 series
system
60-2 Only for version 2 series
5801630 OEC One System Software DVD 1
system
61 6889811 IGBT Inverter Module 1
62 5075984 ASM, Collimator 1
63 5085170 Plastic, 9” I.I. cover 1
64 5604337 Foot Switch with Save Button _10m 1 Only for version 1 series
system
65 5611023 Foot Switch with Save Button _5m 1 Only for version 1 series
system
66 5085113 Hand Switch 1
67 5075902 Front Wheel Kit 1
68 6889801 Steering Handle Kit 1
69 5075904 Rear Steering Wheel Plate Kit 1
70 5333085 Cross-Arm Brake Handle Kit 1
71 5075906 Wig-Wag Brake Handle Kit 1
72 5333087 Orbital or Rotational Brake Handles Kit 1
73 5075921 Linear Actuator Kit 1
74 5075918 Remove Filter and Sensor Kit 1
75 5085235 Skin Spacer 1
76 5085099 Removable Grid of I.I. Side 1
77 00-878105-02 9” Beam Alignment Tool Assembly 1
78 5075816 Monoblock Cover with Laser Aimer Kit 1
79 5075917 Monoblock Cover without Laser Aimer 1
80 5075923 Firmware Upgrade Kit Tool 1 Tool

7-4
Replacement

Item Part Number Description Q’ty Comments


82 5397914 Monitor Spring Arm 1
83 5307604 UBAT (Universal Beam Alignment) 1 Tool
84 5999915 Wireless Module with Antenna 1
85 5075511 USB DVD Tool 1 Tool
86 5330473-65 Laser Aimer in Image Intensifier Side EN 1
87 7888961 Wireless DICOM Module Collector 1
88 5075905 C-arm Handle Kit (left) 1

7-5
OEC One Mobile C-arm X-ray Product

7.2 Locations of FRU

7-6
Replacement

mp
p

7-7
OEC One Mobile C-arm X-ray Product

7-8
Replacement

7.3 Replacement Overview


Electrical circuits inside the equipment use voltages that are capable of causing serious
WARNING injury or death from electrical shock. Use appropriate precautions.

Please use specified fuses.


WARNING

If the system has power applied, power off the machine and unplug the AC power cord from
WARNING the wall outlet.

Reporting
NOTE For U.S. systems, regarding to 21CFR certified FRU Replacements, it is necessary to complete
and submit FDA Form 2579 after replacement within 15 days, it is to comply with FDA
requirement.

7-9
OEC One Mobile C-arm X-ray Product

7.3.1 Calibration Matrix


For the parts below, the calibration procedure or some follow-up action should be done after the replacement. For detailed
NOTE information, please refer to the replacement procedure.

contrast adjust if needed


X-ray Generator Warm
KV Calibration
mA Calibration
Preheat mA Calibration
mAs Calibration
Camera Centering
Collimator Centering
Collimator Calibration
I.I. Field Size Check
Limiting Field Size Check
ABS Tracking Check&Cal.
Uniformity Calibration
Image Resolution check
DAP Calibration
Reinstall SW

Laser aimer Calibration


Power Tolerance Check
Monitor Brightness and
FRU Description

PWA, Collimator Control Board √ √ √ √


PWA, Mainframe Control Board √ √ √ √ √ √ √ √
PWA, Filament Drive Board √ √ √ √ √ √
PWA, KV Control Board √ √ √ √ √ √ √
ASM, Generator Monoblock √ √ √ √ √ √ √ √ √ √
ASM, Collimator_ HL √ √ √ √ √ √ √
Computer, Hard Disk √ √
I.I. Power Supply_ TSBA √ √ √ √
ASM, Camera, GE1020D √ √ √ √ √
ASM, 9” Image Intensifier √ √ √ √ √ √
Bundle Cable √ √ √ √ √ √ √
Monoblock Cover with Laser Aimer Kit √
ASM, Laser Aimer, 9” with All Languages √
Color LCD Monitor and Cover, 27” √
PWA, Power Management Unit √

7-10
Replacement

7.3.2 Calibration Tool Matrix


Standard tools are not included in below matrix, for example: screw driver, TORX screw driver.

X-ray Generator Warm


mA Calibration
Preheat mA Calibration
mAs Calibration
KV Calibration
Camera Centering
Collimator Centering
Collimator Calibration
I.I. Field Size Check
Limiting Field Size Check
ABS Tracking Check&Cal.
Uniformity Calibration
Image Resolution check
DAP Accuracy Ver. and Cal.
Reinstall SW

Laser aimer Calibration

Power Tolerance Check


PN Description

Standard Tool Dose Meter √ √


Standard Tool Oscilloscope Tektronix 2236 or Equivalent √ √ √
Standard Tool Multimeter or Equivalent √ √ √
Standard Tool Spatial Resolution Tool √
Standard Tool Lead Apron √ √
Standard Tool kV Meter √
Standard Tool Ampere Meter or Equivalent √ √
Standard Tool Ruler longer than 12” (30cm) √
Standard Tool Erasable Marker (If needed) √ √
Standard Tool mAs Meter √
Standard Tool USB - Keyboard √
00-877682-01 1mm Copper Sheets, 3 Pieces √
00-878105-02 or 9” BAFT Tool or
5307604 UBAT (Universal Beam Alignment Template) √ √ √ √ √
5085609 PWA, Extend Board √ √ √
5085005 ASM, 9” Cassette Holder (if required) √
N/A Film √
5075511 USB DVD-ROM √

7-11
OEC One Mobile C-arm X-ray Product

7.4 Replacement
Electrical circuits inside the equipment use voltages that are capable of causing serious
WARNING injury or death from electrical shock. Use appropriate precautions.

Please use specified fuses.


WARNING

If the system has power applied, power off the machine and unplug the AC power cord from
WARNING the wall outlet.

7.4.1 Tighten Torque and Thread Locker


 

Grid
Screw 6x 4-40
Tighten torque for
0.5Nm
preload
Thread locker LOCTITE 222

Top cover
Screw 2xM5, class4.8
Tighten torque for
4.5Nm
preload
Thread locker LOCTITE 222

I.I. bracket to I.I.


Screw 4xM6, class8.8
Tighten torque for
7.9Nm
preload
Thread locker LOCTITE 242 or 243
Screw head paint Yes, will check it during
mark PM

7-12
Replacement

I.I. bracket to C-arc


Screw 4xM8, class8.8
Tighten torque for 19.9Nm
preload
Thread locker LOCTITE 242 or 243

Collimator cover
Screw 4xM4 class4.8
Tighten torque for
1Nm
preload
Thread locker LOCTITE 222

Monoblock waterproof strip


4xM4 class4.8, 2xM6 (for
Screw monoblock handle) also
hold the waterproof
Tighten torque for
1Nm
preload
Thread locker LOCTITE 222

Monoblock handle
Screw 2xM6, class8.8
Tighten torque for
7.9Nm
preload
Thread locker LOCTITE 242 or 243

Monoblock
Screw 4xM8, class8.8
Tighten torque for
19.9Nm
preload
Thread locker LOCTITE 242 or 243

7-13
OEC One Mobile C-arm X-ray Product

Monoblock connection analysis


Screw 4xM8, class8.8
Tighten torque for
19.9Nm
preload
Thread locker LOCTITE 242 or 243
check it during PM Yes

Monitor handle
Screw 8xM4, class8.8
Tighten torque for
2.8Nm
preload

Monitor and spring arm fix support


Screw 4xM5, class8.8
Tighten torque for
2.8Nm
preload
Thread locker LOCTITE 222

Screw 4xM4+4xM4, class8.8


Tighten torque for
2.3Nm
preload
Thread locker LOCTITE 242 or 243

4x #10(0.19in)-3/
Screw
4(length)
Tighten torque for
4.5Nm
preload
Thread locker LOCTITE 222

7-14
Replacement

Monitor cover
Screw 6xM4, class8.8
Tighten torque for
1.5 Nm
preload

Extension arm handle


Screw 2x M5, class8.8
Tighten torque for
5.8Nm
preload
Thread locker LOCTITE 242 or 243

Extension arm base assembly


3xM6 (tensile force)+
Screws 2xM6 (shearing
force)class8.8
Tighten torque for
9.4Nm
preload
Thread locker LOCTITE 242 or 243

C-arc
Thread Fine M10, stainless steel
Tighten torque for
20Nm
preload
Thread locker LOCTITE 242 or 243

7-15
OEC One Mobile C-arm X-ray Product

7.4.2 System Covers and Remove


Never allow anyone to use the system when any cover has been removed. Use extreme
WARNING caution if you intend to troubleshoot the equipment with the covers off and power applied.
Failure to heed this warning may result in death, personal injury or equipment damage.
Rear Cover
1. Disconnect AC power plug from AC outlet.
2. Remove four cosmetic caps, and remove four screws. Then remove the rear cover from system.
C-arm Front Cover
1. Remove the rear cover first. Remove the four screws securing both sides of the frame.
2. Disconnect the footswitch, slowly move front cover away from system.
Top Cover
1. Release and remove the screws of the driving handle and steering handle, then remove the two
handles.
2. Remove the rear cover first. Then remove front cover and front small cover.
3. Release and remove the screws of the top cover.
4. Remove the upper part of emergency switch by opening the limit switch.
5. Disconnect the power on/off cable, up/down cables.
6. Remove the top cover carefully.
Toe Top Cover
1. Remove the rear and front covers.
2. Release and remove the fixed screws from the bottom of the cover.
3. Remove the toe top cover carefully.
Monitor Rear Cover
1. Release and remove one screw, then remove the small monitor cover (Pull the bottom of the small
monitor cover out first , then pull the whole small monitor cover down).
2. Release and remove all fixed screws from the large monitor cover.
3. Disconnect the exposure indicator cable connector and remove the monitor cover.
Image Intensifier Top Cover
1. Position the C-arm for easy access.
2. Loosen and remove two screws of the image intensifier top cover.
3. Remove the image intensifier top cover.
Collimator Cover
1. Place the system in a proper position.
2. Release and remove the screws of the collimator cover.
3. Remove the collimator cover.
Cross- arm Cover
1. Lock the cross-arm brake handle.

7-16
Replacement

2. Remove the two screws of the cross arm brake handle, then remove the handle.
3. Cut or remove the green label, remove all fixed screws. Remove the cross arm cover.
4. Cut or remove the blue label, then remove the fix screws, remove the left side cover and right side
cover.

7.4.3 Computer Internal Equipment


Part number
P/N: 5085509 Computer, Hard Disk
P/N: 6888964 Computer, Display Card
P/N: 6888965 Computer, Memory Bank(version 1.0 series system)
P/N: 9888965 Computer, Memory Bank(version 2.0 series system)
P/N: 6888966 Computer, Mainboard Assembly(version 2.0 series system)
P/N: 9888966 Computer, Mainboard Assembly(version 2.0 series system)
P/N: 6888963 Computer, LAN Card Suite
P/N: 5999026 Computer Power Supply
P/N: 9888961 Computer, Solid State Drive, Cine option (only for version 2.0 series system)
Tools and test equipment
FSE standard tools
Removing and replacing
1. Brake and power off the system.
2. Disconnect the power cord from the AC outlet.
3. Remove the front cover and rear cover.
4. Release the screw on the back of the computer cover.
5. Remove the computer side cover.
6. Disconnect the hard disk cables from the hard disk.
7. Release and remove the fixed screws.
8. Remove the hard disk assembly.
9. Release and remove the screws of the bracket by sliding in the direction of arrow.
10. Remove the fixed support, then replace with a new hard disk.
11. Remove the display card, then replace with the new one.
12. Remove the memory bank, then replace with the new one.
13. Release and remove the PMU board top fixed screw, then put the PMU board in the position.
14. Disconnect the computer cables.
15. Release and remove the computer fixed screws, then disconnect the power cable.
16. Remove the computer.
17. Release and remove the LAN card fixed screw.
18. Disconnect LAN card suite power cable and adapter cable.
19. Release and remove the fixed screw, then remove the both cards.

7-17
OEC One Mobile C-arm X-ray Product

20. Disconnect the mainboard assembly cables, then release and remove the fixed screws.
21. Release and remove the fixed screws outside, then remove the fixed plate.
22. Remove the mainboard assembly.
23. Disconnect the power supply cables, then release and remove the fixed screws.
24. Remove the power supply.
25. Reinstall computer internal components by referring to the above removal steps.
26. Place the computer in the original position, then recover the all cables and screws.
Calibration and test
1. Ensure that the new board is properly grounded.
2. Plug the power cord into the AC outlet and power on the system.
3. Verify that the all functions can work normally.
Finish
Dispose of the removed parts as per local regulations.
1. Replacing mother board, LAN card suite and hard disk needs to have the system
NOTE software reloaded, if needed refer to section 5.3. New license will need to be generated.
2. Replacing hard disk requires backup configuration in advance and needs the calibration
to be redone. Refer to section 7.3.1 Calibration Matrix list.

7.4.4 System Power and HV Power Filter


Part number
P/N: 5331600 MISC, System Power and HV Power Filter
Tools and test equipment
FSE standard tools
Removing and replacing
1. Brake and power off the system. Disconnect the power cord from the AC outlet.
2. Remove the rear and front covers.
3. The system power filter is located at power inlet support, and it can be easily removed.
4. The HV Power Filter is behind of the system frame board, the computer must be removed first.
5. After removing the computer, disconnect the cables and remove the fixed screws.
6. Remove the HV Power Filter and replace with the new one.
7. Reinstall the computer and all cables to original state.
Calibration and test
1. Plug the power cord into the AC outlet and power on the system.
2. Check the exposure function is working normally.
Finish
Dispose of the removed parts as per local regulations.

7-18
Replacement

7.4.5 DC Power Supply


Part number
P/N: 5085800 MISC, DC Power Supply +5V,+15V,-15V and +24V
P/N:5085801 MISC, DC Power Supply +5V, +12V and +24V
Tools and test equipment
FSE standard tools
Removing and replacing
1. Brake and power off the system. Disconnect the power cord from the AC outlet.
2. Remove the rear and front covers.
3. Remove all cables of PS1 and PS2. Remove the left side fixed screws.
4. Take out the power supply assembly.
5. Install the new power supply assembly, and reconnect the cables.
Calibration and test
1. Plug the power cord into the AC outlet and power on the system.
2. Check all functions to make sure they are working normally.
Finish
Dispose of the removed parts as per local regulations.

7.4.6 IGBT Inverter Module


Part number
P/N: 6888116 IGBT Inverter Module
Tools and test equipment
FSE standard tools
Torque tool
Removing and replacing
1. Brake and power off the system. Disconnect the power cord from the AC outlet.
2. Remove the rear and front covers.
3. Remove or loosen the power inlet fixed screws.
4. Move the power inlet bracket to the farthest position.
5. Remove the PVC board, and remove all cables.
6. Remove the fixed screws, and remove the fan power cable.
7. Replace with the new IGBT Inverter Module and refer to the steps above to recover all changes
including the fan power cable.

7-19
OEC One Mobile C-arm X-ray Product

Calibration and test


1. Plug the power cord into the AC outlet and power on the system.
2. Refer to section 7.3.1 calibration matrix list.
Check the exposure function to make sure system works normally.
Finish
Dispose of the removed parts as per local regulations.

7.4.7 DC Bus Capacitor


Part number
P/N:5329278 MISC, DC Bus Capacitor
There are two capacitors here but only one in FRU kit. Please identify the failure for the part
NOTE to determine the quantity of FRU kits needed.

Tools and test equipment


FSE standard tools
Removing and replacing
1. Brake and power off the system. Disconnect the power cord from the AC outlet.
2. Remove the rear and front covers.
3. Disconnect the cables. Release and remove the fixed screws. Then remove the DC power supply
assembly.Find the capacitor.
Measure the voltage value by the multimeter. Verify the voltage value is 0V.
C A U T IO N

4. Remove the safety caps and fixed screws, disconnect the cables.
5. Remove the frame fixed screws.
6. Remove DC bus capacitor assembly. Release the fixed screw and remove the capacitor.
7. Replace with new one and refer to steps above to recover it.
Calibration and test
1. Plug the power cord into the AC outlet and power on the system.
2. Check exposure function is working normally.
Finish
Dispose of the removed parts as per local regulations.

7-20
Replacement

7.4.8 Rectifier Bridge


Part number
P/N:5329275 MISC, Rectifier Bridge
Tools and test equipment
FSE standard tools
Removing and replacing
1. Brake and power off the system. Disconnect the power cord from the AC outlet.
2. Remove the rear and front covers.
3. Remove the power supply assembly.
4. Disconnect rectifier bridge.
Do not touch the capacitors unless power has been completely disconnected and they have
C A U T IO N
been discharged.

5. Remove the fixed screw, and remove the rectifier bridge.


6. Replace with new one and refer to above steps to recover it.
Calibration and test
1. Plug the power cord into the AC outlet and power on the system.
2. Check exposure functions are working normally.
Finish
Dispose of the removed parts as per local regulations.

7.4.9 Power Management Unit


Part number
P/N: 6888806-1 PWA, Power Management Unit
Tools and test equipment
FSE standard tools
Torque tool
Removing and replacing
1. Brake and power off the system. Disconnect the power cord from the AC outlet.
2. Move the C-arm horizontally forward to the farthest position.
3. Remove the rear cover and front cover.
4. Remove back side PVC cover.
5. Release and remove the top fixed screw, then position the PMU assembly.
6. Disconnect all cables. Remove all fixed screws.

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OEC One Mobile C-arm X-ray Product

7. Remove the PMU board and replace with the new one.
8. Reinstall and tighten all screws.
9. Reinstall all cables and PVC cover to original state.
Calibration and test
1. Plug the power cord into the AC outlet and power on the system.
2. Refer to section 7.3.1 calibration matrix list.
3. Check all functions to make sure they are working normally.
4. Shut down and recover system.
Finish
Dispose of the removed parts as per local regulations.

7.4.10 Tablet Control Panel


Part number
P/N: 6888902 Tablet Control Panel
Tools and test equipment
FSE standard tools
Torque tool
Removing and replacing
1. Brake and power off the system. Disconnect the power cord from the AC outlet. Remove both side caps
and remove the nut, then remove the big screw.
2. Remove the fixed screws of the tablet support cover.
3. Disconnect the cables.
4. Replace with new one and refer to above steps to reinstall it.
Calibration and test
1. Plug the power cord into the AC outlet and power on the system.
2. Check tablet function to make sure it is working normally.
Finish
Dispose of the removed parts as per local regulations.

7-22
Replacement

7.4.11 Monitor and Exposure Indicator


Part number
P/N: 6888905 Color LCD Monitor and Cover, 27”
P/N: 5885786 Exposure Indicator
Tools and test equipment
FSE standard tools
Torque tool
Removing and replacing
1. Brake and power off the system. Disconnect the power cord from the AC outlet.
2. Secure the extension arm to monitor holder. Brake the extension arm.
3. Remove monitor small cover. Disconnect all cables, and disconnect the exposure indicator cable.
Remove the monitor big cover’s fixed screws and then remove the cover.
4. Release and remove the screws, then remove the exposure indicator.
5. Remove the fixed screws of monitor. Remove the monitor slowly.
6. Replace with new one and refer to the steps above to reinstall it.
For countries and regions that need to meet DIN 6868-157 requirements such as Germany,
NOTE etc, the FSE needs to perform step 7-9. Otherwise, ignore it.

7. Check system software complete version and monitor revision. Reload the system software complete
version according to the following table.
Monitor and System Software Configuration Matrix

Color LCD Monitor System Software System Software


PN: 6888905 Complete Version 01.02-01 Complete Version 01.03-01

Cannot meet DIN 6868-157 Cannot meet DIN 6868-157


Monitor Rev 1
requirement requirement
Cannot meet DIN 6868-157
Can meet DIN 6868-157
Monitor Rev 2 requirement
requirement

For countries and regions that need to meet DIN 6868-157 requirements such as Germany,
NOTE etc. the FSE needs to check whether the monitor revision is REV2 and later, and the
software complete version is 01.03-01 and later.
8. In the monitor “Gamma” UI, need to select DICOM curve for DIN 6868-157 requirements. For detailed
instruction, refer to section 4.16.6.
9. Access to Administration UI make sure “Gamma to DICOM” is checked, then access to Setup screen
make sure “Test Patterns…” is enabled. For detailed instruction, refer to section 4.16.7.

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OEC One Mobile C-arm X-ray Product

Calibration and test


1. Plug the power cord into the AC outlet and power on the system.
2. Verify the new monitor functions are working normally.
Finish
Dispose of the removed parts as per local regulations.

7.4.12 Monitor Spring Arm


Part number
P/N: 5397914 Monitor Spring Arm
Tools and test equipment
FSE standard tools
Torque tool
Removing and replacing
1. Secure the monitor spring arm.
2. Release and remove the screws of the monitor cover, then disconnect the exposure indicator cable.
3. Disconnect the cables of the monitor.
4. Release and remove the screws, then remove the monitor.
5. Remove the fixed screws and plate of monitor cables, then remove the monitor cables from spring arm
holder.
6. Release and remove the top two screws, then release the bottom screw.
7. Remove the fixed support of the monitor.
8. Loosen the spring arm securing material used in step 1 above slowly.
9. Remove the cover.
10. Release and remove the fixed screws of the spring arm.
11. Remove the spring arm, then replace with the new one and refer to the steps above to reinstall it..
Calibration and test
1. Plug the power cord into the AC outlet and power on the system.
2. Verify monitor spring arm and monitor functions to make sure they are working normally.
Finish
Dispose of the removed parts as per local regulations.

7-24
Replacement

7.4.13 Monitor Cable


Part number
P/N: 6888730 Monitor cable
Tools and test equipment
FSE standard tools
Torque tool
Removing and replacing
1. Remove the monitor cover.
2. Remove the monitor.
3. Remove the tablet.
4. Release and remove the screws, then remove the horizontal cross-arm handle.
5. Remove all bottom fixed screws of the cover.
6. Remove the cover.
7. Cut or remove the blue label, then release and remove the screws.
8. Remove both side covers.
9. Disconnect the cable from computer.
10. Remove the fixed screws of cables and the grounding wires.
11. Disconnect the tablet power cables from power distribution panel (J1-25 R and J1-27 R).
12. Remove the fixed screws.
13. Disconnect the grounding wire.
14. Release and remove the fixed screws.
15. Remove the monitor arm from system.
16. Release and remove the fixed screws, then remove the cover.
17. Release and remove the fixed screws, then disconnect the earth line. Remove the fixed block.
18. Remove the cable from the monitor arm carefully.
19. Replace with new one and refer to the steps above to reinstall it.
Calibration and test
1. Plug the power cord into the AC outlet and power on the system.
2. Verify tablet and monitor function to make sure they are working normally.
Finish
Dispose of the removed parts as per local regulations.

7-25
OEC One Mobile C-arm X-ray Product

7.4.14 Battery Pack


Part number
P/N: 5885855 Battery Pack , 12V 7Ah (2 units per order, 2 units per system)
Tools and test equipment
FSE standard tools
Torque tool
Removing and replacing
1. Remove rear cover. Release the fixed screw, then remove the fixed screw and fixed plate.
2. Release and remove the fixed screw of the battery.
3. Disconnect the cable, then pull out the battery assembly.
4. Remove the battery, then replace with the new one and refer to the steps above to reinstall all
components.
Calibration and test
1. Plug the power cord into the AC outlet and power on the system.
2. Check system to insure that no battery or UPS error warning appears. .
Finish
Dispose of the removed parts as per local regulations.

7.4.15 Bundle Cable


Part number
P/N: 6888700 Bundle Cable
Tools and test equipment
FSE standard tools, iron wire and tape
Torque tool
Removing and replacing
1. Position the system in the 60 ° position, brake the system, then place the wood block at the bottom of
the system.
2. Remove the rear and front covers.
3. Remove I.I. refer the section 7 replacement.
4. Remove the collimator cover, then disconnect the cables.
5. Release and remove the screws, then remove the fixed plate.
6. Remove fixed screws of the connector cover, then remove the covers.
7. Tie the cables together with the iron wire as specified in the tool list requirements.
8. Slowly remove the I.I. cables from the c-arc.
9. Using the same method as in steps 7 & 8, remove the monoblock and collimator cables.
10. Remove the fixed screws, and disconnect the cables from the fixed supporter.

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Replacement

11. Disconnect the grounding wires.


12. Disconnect the cable connectors.
13. Release and remove the fixed screws.
14. Remove the bundle cable from system.
15. Replace with new one, and refer to the steps above to reinstall all components.
Calibration and test
1. Plug the power cord into the AC outlet and power on the system.
2. Refer to section 7.3.1 calibration matrix list.
3. Check system functions to insure they are working correctly.
Finish
Dispose of the removed parts as per local regulations.

7.4.16 Collimator and Monoblock


Part number
P/N: 5075984 Collimator
P/N: 5085004 Generator Monoblock
Tools and test equipment
FSE standard tools
Torque tool
Removing and replacing
1. Position the C-arm in the 0 ° position, brake the system, then place the wood block at the bottom of
the system.
2. Remove the monoblock handle, the collimator protective shell and the collimator cover.
3. Refer to the steps A-B to replace the collimator.
If only the monoblock is replaced, the collimator does not need to be removed.
NOTE

A. Release and remove the fixed screws, then remove the collimator.
B. Replace with the new one.
4. Refer to the steps A – E as listed below to replace the monoblock.
A. Disconnect the cables to monoblock.
B. Position the C-arm in the 90 ° position.
C. Release and remove the fixed screws of the monoblock.
D. Remove the monoblock carefully.
E. Replace with the new one and refer to the steps above to reinstall all components.
Calibration
1. kV calibration.

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OEC One Mobile C-arm X-ray Product

2. mA calibration.
3. Beam alignment and collimator calibration.
Test
1. Plug the power cord into the AC outlet and power on the system.
2. Check system functions to insure that they are working correctly.
Finish
Dispose of the removed parts as per local regulations.

7.4.17 Image Intensifier, Image Intensifier Power Supply and Camera


Part number
P/N: 5085918 Image Intensifier (I.I.) power supply
P/N: 5767421 Camera
P/N: 5075967 Image Intensifier (I.I.)
Tools and test equipment
FSE standard tools
Torque tool
Removing and replacing
Some setps related to I.I. power supply or I.I. are recommended to be completed by two
NOTE people.

1. Position the C-arm in the 0 ° position, brake the system, then place the wood block at the bottom of the
system.
2. Remove the I.I. top cover and the counterweight.
3. Disconnect the camera cables.
4. Remove the fixed screws of the camera, then remove the camera.
5. Disconnect the I.I. power supply cables.
6. Remove the fixed screws of the I.I..
It is recommended that two people complete the following steps.
NOTE

7. Raise the I.I slowly from the fixed slot carefully. Then remove the top fixed screws of the I.I. power
supply, and then remove the I.I. power supply cables from I.I. frame.
8. Remove the I.I. from the system.
9. Remove the power supply and replace with the new one.
10. Remove the bottom counterweight of the I.I. and the grid and other misc components, then install them
to the new I.I. and refer to the steps above to reinstall it.
Calibration
1. Beam alignment calibration.
2. Camera center calibration.

7-28
Replacement

3. Collimator calibration.
4. DAP calibration.
5. Uniformity calibration.
Test
1. Plug the power cord into the AC outlet and power on the system.
2. Check system functions to insure that they are working properly..
Finish
Dispose of the removed parts as per local regulations.

7.4.18 PCB Box Board


Part number
P/N: 5085603 PWA, Collimator Control Board
Tools and test equipment
FSE standard tools
Torque tool
P/N: 6888800-1 PWA, Mainframe Control Board (version 1.0 series system)
P/N: 6888800-2 PWA, Mainframe Control Board (version 2.0 series system)
Tools and test equipment
FSE standard tools
Torque tool
P/N: 5085604 PWA, Filament Drive Board
Tools and test equipment
FSE standard tools
Torque tool
P/N: 5085601 PWA, Mother Board
Tools and test equipment
FSE standard tools
Torque tool

7.4.19 kV Control Board


Part number
P/N: 5085610 PWA, KV Control Board
Tools and test equipment
FSE standard tools

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OEC One Mobile C-arm X-ray Product

Torque tool
Removing and replacing
1. Remove the rear cover.
2. Remove old kv Control Board and replace with a new one.
3. Reinstall all the covers refer to before steps.
Calibration
1. Refer to section 7.3.1 calibration matrix list.
Test
1. Plug the power cord into the AC outlet and power on the system.
2. Check system functions to insure that they are working properly..
Finish
Dispose of the removed parts as per local regulations.

7.4.20 Updown Board


Part number
P/N: 6888807 PWA, Updown Board
Tools and test equipment
FSE standard tools
Torque tool
Removing and replacing
1. Remove the rear and front covers.
2. Remove the toe top cover.
3. Disconnect all the cables of Updown Board.Remove the screws that secure Updown board to chassis.
4. Remove old Updown Board and replace with a new one.
5. Plug the cables to corresponding connectors.
6. Reinstall all the covers refer to before steps. Restart system and press lift and down vertical column
switches to verify Updown board is functional.
Test
1. Plug the power cord into the AC outlet and power on the system.
2. Check system functions to insure that they are working properly..
Finish
Dispose of the removed parts as per local regulations.

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Replacement

7.4.21 Fuse Collector


Part number: 5075919
The fuse collector contains 5 kinds of fuse. You can choose the fuse to replace according to the
requirement.

Item P/N Description Qty

1 5459754 FUSE 2.5A 250V 5X20MM 3


2 5457478 FUSE 1.25A 250V 5X20MM 5
3 5439918 FUSE 250V 0.5A 5X20mm 1
4 5331602 MISC, FUSE MODEL 6.3A, EVR 1
5 46-267217P30 PROTECTION FUSE, 3.15A, 5 x 20 mm, 1
TIME DELAY, 250V, 2AG
6 46-267217P29 PROTECTION FUSE, 1A, 5 x 20 mm, 1
TIME DELAY, 250V, 2AG

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OEC One Mobile C-arm X-ray Product

7-32
Chapter 8 Periodic Maintenance
OEC One Mobile C-arm X-ray Product

8.1 Overview

This procedure describes how to conduct performance checks and maintenance procedures. Use the
procedures in conjunction with PM checklist in section PM checklist of this chapter. Follow the procedures in
the order they appear here and record all required information on the checklist.
Serious injury and property damage can result from incorrectly performed service procedures. Observe all
operating and safety procedures in this document.

Procedures should be performed by service personnel specifically trained by GE Healthcare,


WARNING Inc. to calibrate the OEC One.

8.1.1 Safety
Ingress of Fluids

The system must never be operated or stored in locations where conductive fluids, like water
WARNING
and saline solution, might spill on the equipment.

Always unplug the AC power cable from the wall outlet before cleaning the equipment. Do not allow water,
soap, or other liquids to drip into the equipment and cause short circuits, electric shock and fire hazards.

Unauthorized Modifications
Under no circumstances should the safety interlock in the system be bypassed, jumped, or otherwise
disabled.

All GE Healthcare systems comply with International Electro Technical Commission safety
NOTE standard IEC-60601. Do not connect any external device to the system that does not meet
the requirements of IEC-60601. Only devices provided or approved by GE Healthcare, Inc.
should be connected to the system.

Motorized Mechanical Operation


The Vertical Column is motorized and should be observed continuously during operation to avoid pinching
or colliding with people and objects.
If covers are removed, use extreme care when operating motorized features. Do not carelessly place objects
on the equipment or bump or lean against the equipment. Do not wear loose clothing that may be caught
by mechanical mechanisms. Keep hands and fingers clear of motorized equipment while the motors are in
operation.

Electrical Shock

This system can generate lethal voltages. Practice safe electrical testing procedures when
WARNING performing periodic maintenance procedures.

8-2
Periodic Maintenance

After taking X-rays, the high voltage cables can retain a lethal charge, even if you power
WARNING down the system. Even though the contacts are recessed, high voltages can arc several
inches from their terminals if the cables are removed from the connector wells. Use
caution when disconnecting high voltage cables even when the power is turned off. If you
remove these connections, immediately discharge their contacts against the high voltage
tank case (ground).
X-Radiation Exposure
The X-ray tube assembly produces X-radiation when energized. Never operate this device without X-ray
shielding in place. Use lead shielding and draping to protect personnel.
Lead aprons, radiation monitors, and appropriate radiation shields must be utilized for the
WARNING protection of all personnel in the vicinity while performing tests. No individuals should ever
be used as a phantom or demonstration aid. Do not produce radiation in hallways.
Many of the PCB's in this system contain components, which are sensitive to Electro-Static
C A U T IO N
Discharge (ESD). Observe ESD safety procedures.

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OEC One Mobile C-arm X-ray Product

8.1.2 Tools and Test Equipment


In addition to standard service tools and test equipment, the following special tools and test equipment are
required to complete the PM procedure.

Standard Tools

Item Tool

1 Oscilloscope Tektronix 2236 or equivalent


2 Multimeter or equivalent
3 Spatial Resolution Tool
4 Lead Apron
5 kV meter
6 Dosimeter
7 Ampere meter or equivalent
8 Ruler longer than 12" (30cm)
9 Erasable marker (whiteboard marker)
10 mAs meter
11 Precision flat head screwdriver (3mm or less) to adjust camera iris, focus
12 Transparent adhesive tape, with cutter (or need scissors or knife to cut the tape)
GE Tool
Item Tool GE part number
1 Three copper sheets, each 1mm thick 00-877682-01
2 9" BAFT Tool or UBAT 00-878105-02 or 5307604
3 PWA, extend board 5085609

Periodic maintenance of the system is required to maintain the system lifecycle. The first periodic
maintenance shall be implemented after approximately one year’s use, then it is suggested to do once per
year by GE qualified service engineer.

8-4
Periodic Maintenance

8.2 PM Checklist
During the periodic maintenance (PM), the FSE needs to follow the PM checklist every time to check the
system. Please find the detailed check list in Appendix-2 OEC One PM Checklist.

8-5
OEC One Mobile C-arm X-ray Product

8.3 Administrative Information

Medical Facility Information:


Enter all information about the medical facility where the system is installed.
Field Service Engineer Information:
Enter Field Service Engineer name, Region ID number and Employee ID number.
System Configuration:
Complete each field in the System Configuration section. This section identifies specific information about
the system being maintained.

8.4 Safety Inspection

Follow this procedure to inspect system components. Look for loose, damaged, or missing parts. Check each
component for proper operation.

Electrical circuits inside the equipment use voltages that are capable of causing serious injury
WARNING
or death from electrical shock. Use appropriate precautions.

If the system has power applied, power off the system and unplug the C-arm’s AC power cord from AC
outlet. Remove C-arm and workstation covers as needed.

8.4.1 Anti-static Drag Wires

Check the system’s anti-static drag wires. It is underneath the C-arm system. The wires must be securely
attached to the system and not be damaged or encumbered by debris.

8.4.2 Electrical Plug And Power Cord

Inspect the C-arm system’s AC power cord and AC line plug for damage and missing parts. Make sure all
wiring insulation is intact. Ensure that there are no broken or frayed wires. Make sure grounding pin is
present on AC line plug, and that all conductors on plug are secure and in good condition.
Some devices such as high voltage cables and electrolytic capacitors can retain a dangerous
WARNING static charge for long periods after power has been removed. Do not touch these
components unless power has been completely removed and they have discharged.

8.4.3 Footswitch Cable And Pins


Inspect footswitch cable and verify that the cable, connector and pins are not damaged.

8-6
Periodic Maintenance

8.4.4 Bundle Cables


Check that the C-arm bundle cable and monitor bundle cable are not damaged.

8.4.5 Ground Continuity


Perform the ground continuity test described below.
Do not perform this continuity test with the AC plug connected to a power receptacle.
WARNING

Verify continuity between the following:

From To Spec

Any one of screws to fix Monitor AC Power Plug Ground Pin < 0.5 

Any one of screws on the tube cover AC Power Plug Ground Pin < 0.5 

Any one of screws to fix the Image Intensifier AC Power Plug Ground Pin < 0.5 

Metal surface of central C-arm


AC Power Plug Ground Pin < 0.5 
Comments: Close to the zero mark of orbital

Metal surface of footswitch connector AC Power Plug Ground Pin < 0.5 

If there is special ground continuity regulation for in-use system, FE shall follow local
NOTE regulation and perform the test by Ground Continuity test equipment.
The special regulations for Ground Continuity are as follows:
The resistance measured from the ground pin on the power cord to any accessible
conductive surface in the system (e.g., the chassis) shall not exceed 0.3 Ohm as per
European norm EN 62353, specification.
The resistance measured from the ground pin on the power cord to any accessible
conductive surface in the system (e.g., the chassis) shall not exceed 0.2 ohms as per IEC
60601-1 or equivalent.

8.4.6 Facility Leakage Current Test Notification

The medical facility may require that the facility’s biomedical department or the 3rd service party to
perform current leakage test on the system before it is put into the service and during the periodic
maintenance. In that case, notify the service personnel of following warning:
Power must be off on the system before and during any tests. Do not interrupt power to the
WARNING system at any time while the system is booting or shutting down to avoid file system
corruption.

8-7
OEC One Mobile C-arm X-ray Product

8.5 System Internal Clean


8.5.1 Computer Clean
1. Remove the system rear and front covers.
2. Remove the computer side cover.

3. Clean the computer outside and inside.


4. Check that the fan is working normally.
5. Check all internal cards and cables.
6. Check all external cables and make sure that they are connected well.

Before installing a new coin cell battery, measure the new battery’s voltage and make sure
NOTE that it is at least 3.2 VDC.

7. It is recommended that the cell battery be replaced regularly for the next 3/6/9 years after system being
installed.

8-8
Periodic Maintenance

8.5.2 Filter Clean


1. Remove the rear cover and front cover,
2. Remover the toe top cover
3. Clean the filter of both sides as pictured below.

8-9
OEC One Mobile C-arm X-ray Product

8.6 Battery Performance Check


It is recommend that the battery pack be replaced regularly for the next 3/6/9 years after
NOTE being installed.

8.6.1 System Battery Pack Performance check


1. Power off the system.
2. Remove the system rear cover. Disconnect the battery cable.

3. Measure the battery voltage, which should be 26.5±0.5VDC of power saturated state. Then restore the
battery cable.
4. After powering on the system, unplug the system power cable, listen if the system begins to beep and
the monitor loses power. Check to see if the tablet control panel is still live and gives AC power lost
warning. If no “battery low” warning is displayed on the tablet control panel, the battery performance is
normal. If the system gives “battery low” warning, the battery performance test may have failed
For version 1 series system, the battery can supply the system about 20seconds with no
NOTE AC power input; for version 2 series system, the battery can supply the system about
5minutes with no AC power input, otherwise the system will shut down automatically.
5. Shut down the system, check the battery cable connect well. Reconnect the system rear cover.

8.6.2 Computer Cell Battery Check


1. Power off the system.
2. Remove the system rear and front covers.
3. Remove computer side cover.
4. Find the computer cell battery of main board.
5. Check the voltage of the cell battery. Replace cell battery if the test voltage is under DC2.5V.

8-10
Periodic Maintenance

8.7 Functional Checks


8.7.1 System Movement Check
1. Push the system and verify that it is securely attached to the wheels and that they roll smoothly
without vibration.

2. Verify that both side brake pedals function. Presee the brake pedal to the brake position to lock the
system’s wheels and steering handle. Press the brake to free position to release the system’s wheels
and steering handle. The pedals are located on each side of the system.

8.7.2 Mechanical Movement Check


Monitor movement check:
1. Unlock the extension arm, to verify that extension arm can move freely.

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OEC One Mobile C-arm X-ray Product

2. Unlock the spring arm lock, hold the monitor handle to verify that the monitor can be tilted and moved
freely.

Tablet Movement Check


1. Hold the tablet to verify that it can be tilted freely.
2. Verify that tablet can be freely rotated.

Wig-wag Movement Check


1. Release the wig-wag brake.

8-12
Periodic Maintenance

2. Move the mechanics through the entire operational range. Verify wig-wag for ease of movement
without excessive play.
3. Verify that locking the Wig-wag brake prevents wig-wag motion.

If wig-wag brake can not prevent wig-wag motion effectively, or the lock and release
NOTE positions can not be matched as the label indicates, perform procedure listed below to
refresh the force of wig-wag brake.
Wigwag Brake Check
1. Pull up the handle far enough (about 3mm) that it clears the fixed shaft.
2. Turn the handle anticlockwise.
3. Push down the handle.
Horizontal Movement Check
1. Unlock Horizontal brake and fully extend and retract the Horizontal Cross-arm.

2. Verify that the Cross-arm moves smoothly and quietly through the bearing block without excessive
play.
3. Place the Cross-arm brake in the lock position.
4. Verify that the cross-arm does not move.
Make sure cross arm is fully retracted and brake is set before moving C-arm. Equipment damage or
personal injury may otherwise result.

8-13
OEC One Mobile C-arm X-ray Product

C-arm Orbital Rotation Check

When you release the orbital movement brake, place your other hand on the C-arm so that you
C A U T IO N have control of the C-arm’s movement.

1. Release the orbital brake.

2. Verify that C-arm orbits smoothly in its cradle without excessive play.

3. Verify that the entire orbital scale is readable and in good condition.
4. Set the brake handle to lock position and verify that C-arm locks firmly in place.

8-14
Periodic Maintenance

Lateral Rotation Check


1. Release lateral rotation brake.

2. Verify C-arm rotates smoothly in both directions.


3. Lock the brake and verify the brake locks C-arm firmly in position.

Before transporting the system, please make sure the brake handles: the C-arm orbital
WARNING rotation brake, the lateral rotation brake, the wig-wag brake, and the horizontal cross-arm
brake are locked. Otherwise, equipment damage or personal injury may result.

If lateral brake can not prevent lateral motion effectively, perform adjustment to refresh the
NOTE force of lateral brake refer to Section 4.19.

8.7.3 Power On/Off Check


Observe safety procedures when operating motorized features.
WARNING

Perform the following steps with the system powered up and normally booted.
1. Connect the footswitch cable to the C-arm.
2. Plug the AC power cord into the receptacle.
3. Press the system on key. Verify that the C-arm system completes its software boot and initialization
with no errors reported on the monitor and tablet control panel displays.
4. Press the system power on/off button. Verify that the system can successfully shut down.

8-15
OEC One Mobile C-arm X-ray Product

8.7.4 Vertical Column Operation Check


Power on the system. The vertical column motor is actuated by pressing the up and down vertical column
switches located on top cover of the mainframe. Use the vertical column to elevate the C-arm upward and
downward.

Press and hold or to lift and lower the C-arm, the upward movement continues until the switch is
released or the movement reaches its limits. The maximum distance is about 40cm.
When C-arm can not be driven down by only pressing down switch, please release the switch, make sure
there are no obstacles between the C-arm and the T-Base. Make sure there are no obstacles between Cross-

arm and console. Press the switch one more time, it will lower C-arm to the lowest position.
Please make sure C-arm will not be blocked by any other objects during the vertical
WARNING movement. If there are any obstacles, system will sound two beeps and stop movement.
Please check and clear the obstacle. Then the raising or lowering of the C-arm can continue
to raise or lower the C-arm. If any failure occurs, please contact GE Healthcare authorized
service engineer.
When positioning the vertical column, observe the moving assemblies to ensure the safety
of patients and hospital personnel.

8.7.5 System Control Check


Refer to Section 3.7.4 to verify all functions.

8.7.6 System Operation Check


Refer to Section 3.7.5 to verify system operation functions.

8-16
Periodic Maintenance

8.7.7 DICOM Operation Check


Refer to Section 3.6.6 to verify the DICOM function check.

8.8 X-ray Generator Accuracy Check


Below tests are to measure the kVp/mA/mAs accuracy of the X-ray generator system.

8.8.1 kVp Accuracy Check


Refer to Section 4.2 to perform kVp accuracy check and perform kVp calibration if needed.

8.8.2 mA Accuracy Check


Refer to Section 4.2 to perform mA accuracy check and perform mA calibration if needed.

8.8.3 mAs Accuracy Check

Refer to Section 4.2 to perform mAs accuracy check and perform mAs calibration if needed.
If the film mode is turned off in service mode by unchecking the check box, mAs accuracy
NOTE check is not needed in periodic maintenance.

8-17
OEC One Mobile C-arm X-ray Product

8.9 Beam Alignment Check


Refer to chapter 4.6 Beam Alignment to Check and Adjustment .
1. If any regulatory body or user requires that the collimator be visible in the image, the
NOTE service engineer could select “The collimator iris is required to be visible in FOV” to
calibrate it.
2. German regulations require that the collimator must be visible on two sides of the image,
which are not opposite. For the systems installed in Germany, adjust the collimator iris
until the leaves are visible as pictured below.

3. Australia regulations require that the beam limiting device must automatically limit the
primary beam to X-ray image receptor area (within 1% SID), which it must set to the
selected field of the I.I. or image receptor in the fluoroscopic mode. For the systems
installed in Australia, adjust collimator iris until the collimator 8 leaves can be seen in the
image.

8.10 Field Size Check


1. Select relative field size, open the collimator to the maximum, and take an exposure.
2. Read the BAFT tick mark on the boundary of the image. The size of the image should be within the range
of the values below:

Mag Mode NORM MAG1 MAG2


Displayed Image Diameter (mm) 210 ±10 155 ±8 115 ±8
3. If the requirement is not met, you must perform I.I. Field Size Calibration in 4.6.5.

8.11 Collimator Check


Refer to Section 4.9 to check collimator, and perform collimator calibration if needed.

8-18
Periodic Maintenance

8.12 ABS Tracking Check


1. Select auto fluoro mode and the normal(9") field size via control panel.
2. Open the collimator Iris and leaves completely.
3. Place copper filters on the collimator and take exposure. Verify that the kVp tracks within the range
indicated in table below.

Copper Filter Thickness 1mm 2mm 3mm

kVp range 64±4kVp 74±4kVp 82±4kVp

4. Remove all copper filters.


5. If the kVp is not in the range, refer to Section 4.10 to redo calibration.

8.13 Dose Rate Check


1. Using a dosimeter for the measurements, place the dosimeter probe on the I.I. grid center. Use 2mm
copper sheet to cover the beam path on the X-ray tube. Take exposure in auto fluoro mode. Dose rate
should be within:
4.1±0.3mR/min (35.92±2.63uGy/min or 2155±157uGy/hr)
2. Indicate if adjustments were made on the checklist.

8.14 Dose Limitation Check


Refer to chapter 3.7.6 to perform Dose limitation check.

8.15 DAP Accuracy Check


Refer to chapter 4.14 to perform DAP accuracy check. Perform the DAP calibration, if needed.
The field size in the form should be measured by field size measure tool.
NOTE

8.16 Uniformity Calibration


Refer to Section 4.15 to perform uniformity calibration.

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OEC One Mobile C-arm X-ray Product

8.17 Image Resolution Check


Use the converging line pairs/millimeter (Lp/mm) tool on the image intensifier. Verify the resolution in Lp/mm
is equal to, or greater than the following values:

Field Size NORMAL(9") MAG1(6") MAG2(4.5")


Resolution
≥ 2.2 ≥ 2.8 ≥ 3.3
(Lp/mm)
Record test results on PM checklist.
If the resolution check fails, refer to Section 4.6.8 for camera focus calibration.

8.18 Options Functional Check


Refer to Section 3.8 to check options function.

8.19 System Status Backup


Refer to Section 5 to perform below procedure as described below:
1. Perform integrity check.
2. Backup system database.
3. Export system setup and administration configuration, if needed.

8.20 Reporting
8.20.1 Install Equipment Covers
Install all equipment covers that were removed earlier.

8.20.2 Complete PM Comments


Write any comments important to the PM procedure in the comments section of the PM checklist.

8-20
Chapter 9 Technical Reference
OEC One Mobile C-arm X-ray Product

9.1 Overview
The policy of GE Healthcare is one of continuous product development and improvement.
• For this reason, GE Healthcare reserves the right to change the operating characteristics and
specifications of newer products at any time, without prior notice, and without incurring any obligation
relating to previously manufactured items.
• The specifications listed are limited to general performance and physical data. Specifications of
optional equipment provided by other manufacturers are given in the applicable manuals provided
with those options.

9.2 System Specifications


9.2.1 Classification Type
• Class I equipment (as defined by IEC60601-1)
• Type B protection against electric shock (IEC60601-1)
• Ordinary protection against ingress of water
• Degree of Protection:
System: IPX0
Footswitch: IPX8
• Operation Mode:
Continuous operation
• Loading Mode:
Intermittent loading

9.2.2 Environmental Requirements


Operating Conditions:

Temperature: +10°C~+40°C (+50F~+104F)

Humidity: 20%~80% Relative, non-condensing

Atmospheric Pressure: 660hPa~1060hPa

Transportation and Storage:

Temperature: -20°C~+55°C (-4F~+131F)

Humidity: 10%~95% Relative, non-condensing

Atmospheric Pressure: 500hPa~1060hPa

9-2
Technical Reference

9.2.3 Power Requirements

Voltage: AC 100V/110V/120V/200V/220V/230V/240V ±10%


Frequency: 50Hz/60Hz
Rated Momentary Line Current (shorter than 5s):
• 30A(100V/110V/120V)
• 28A (200V)
• 25A (220V/230V/240V)
Rated Continuous Line Current:
• 20A (100V/110V/120V)
• 12A (200V)
• 10A (220V/230V/240V)
Maximum line impedance:
• 0.3Ω (AC 100V/110V/120V)
• 0.6Ω (AC 200V/220V240V)
Maximum line voltage regulation (Percent): 15% at maximum radiographic exposure.
Line voltage regulation means difference between measurement made at the input (primary winding) of
the isolation transformer under standby conditions and measurement at maximum radiographic
exposure, expressed as a percent of measurement at maximum radiographic exposure as the following
equation:
Percent line voltage regulation = 100 (Vn - V1)/V1
Where Vn = no load voltage (standby), and V1 = loaded voltage (maximum radiographic exposure).

9-3
OEC One Mobile C-arm X-ray Product

9.2.4 Physical Specifications


SID (Source Image Distance) 39.4’’ (100cm)

Horizontal travel 7.9’’ (20cm)

Vertical travel 17.3’’ (44cm)

Orbital rotation 120°(90°underscan /30°overscan)

Lateral rotation 410°(±205°)

Wig-Wag 25°(±12.5°)

Weight 310±10kg

9-4
Technical Reference

9-5
OEC One Mobile C-arm X-ray Product

9-6
Technical Reference

9.3 Specification of key Components


Film is only available in version 1 series system.
NOTE

9.3.1 X-ray Generator


• Nominal electric power:
2.0kW (100kV, 20mA, 0.1s)
• Maximum electric power:

Normal Fluoro 440W (110kV, 4mA)


High Level Fluoro 660W (110kV, 6mA; 55kV, 12mA)
High Level Pulse 2.5kW (100kV,25mA,1/2PPS) For version 2 series
system
Low Dose 220W (110kV, 2mA)
Digital Spot 2.2kW (110kV, 20mA) @ 200V, 220V, 230V,
240V;
1.1kW (110kV, 10mA) @ 100V, 110V, 120V
Film 2.2kW (110kV, 20mA) @ 200V, 220V, 230V, For version 1 series
240V; system
1.1kW (110kV, 10mA) @ 100V, 110V, 120V.

• High frequency generator : 40kHz


• Voltage: 40kV~110kVp

Normal Fluoro When the X-ray tube current reaches its highest
value of 4mA, the obtainable highest X-ray tube
voltage is 110kV.
High Level Fluoro When the X-ray tube current reaches its highest
value of 12mA, the obtainable highest X-ray
tube voltage is 55kV
High Level Pulse When the X-ray tube current reaches its highest For version 2 series
Fluoro value of 22.7mA, the obtainable highest X-ray system
tube voltage is 110kV at 1/2 pps;
When the X-ray tube current reaches its highest
value of 6mA, the obtainable highest X-ray tube
voltage is 110kV at 4/8/12 pps

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OEC One Mobile C-arm X-ray Product

Normal Fluoro When the X-ray tube current reaches its highest
value of 4mA, the obtainable highest X-ray tube
voltage is 110kV.
Low Dose When the X-ray tube current reaches its highest
value of 2mA, the obtainable highest X-ray tube
voltage is 110kV.
Digital Spot When the X-ray tube current reaches its highest
value of 20mA, the obtainable highest X-ray
tube voltage is 110kV @ 200V, 220V, 230V, 240V.
When the X-ray tube current reaches its highest
value of 10mA, the obtainable highest X-ray
tube voltage is 110kV @ 100V, 110V, 120V.
Film 20mA, stationary @ 200V, 220V, 230V, 240V, the For version 1 series
obtainable highest X-ray tube voltage is 110kV; system
10mA, stationary @ 100V, 110V, 120V, the
obtainable highest X-ray tube voltage is 110kV.

• Current:

Normal Fluoro 0.1 mA~4 mA; when the X-ray tube voltage
reaches its highest value of 110kV, the
obtainable highest X-ray tube current is 4mA.
High Level Fluoro 0.2 mA~12 mA; when the X-ray tube voltage
reaches its highest value of 110kV, the
obtainable highest X-ray tube current is 6mA.
High Level Pulse 0.2 mA~12 mA; when the X-ray tube voltage For version 2 series
Fluoro reaches its highest value of 55kV, the system
obtainable highest X-ray tube current is 12mA
at 4/8/12pps.
0.2 mA~25 mA; when the X-ray tube voltage
reaches its highest value of 100kV, the
obtainable highest X-ray tube current is 25mA
at 1/2pps
Low Dose 0.1 mA~2 mA; when the X-ray tube voltage
reaches its highest value of 110kV, the
obtainable highest X-ray tube current is 2mA.

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Technical Reference

Digital Spot 0.2 mA~20 mA; when the X-ray tube voltage
reaches its highest value of 110kV, the
obtainable highest X-ray tube current is 20mA
@ 200V, 220V, 230V, 240V.
0.2 mA~10 mA; when the X-ray tube voltage
reaches its highest value of 110kV, the
obtainable highest X-ray tube current is 10mA
@ 100V, 110V, 120V.
Film 1mAs~80mAs @ 200V, 220V, 230V, 240V; For version 1 series
current: 20mA, stationary; the obtainable system
highest X-ray tube voltage is 110kV;
1mAs~40mAs @ 100V, 110V, 120V; current:
10mA, stationary; the obtainable highest X-ray
tube voltage is 110kV.

Film (for version 1 series system):


Voltage: 40~110kV;
mAs: 1.0, 1.3, 1.6, 2.0, 2.5, 3.2, 4.0, 5.0, 6.3, 8.0, 10, 13, 16, 20, 25, 32, 40, 50, 63, 80 mAs @ 200V, 220V,
230V, 240V;
mAs: 1.0, 1.3, 1.6, 2.0, 2.5, 3.2, 4.0, 5.0, 6.3, 8.0, 10, 13, 16, 20, 25, 32, 40 mAs @ 100V, 110V, 120V.
• The lowest Current Time Product or the combination of Loading Factors: 40kVp, 1mAs.
• Pulse Fluoro:
1/2/4/8pps (for version 1 series system)
1/2/4/12/8pps (for version 2 series system)
• Film Mode Duty Cycle (for version 1 series system):
110 kVp @ 20 mA, 4 seconds (80 mAs)
Once per 5 min (1.3%) continuous
Once per 2min (3.3%) for 10 exposures
• kVp Accuracy 7%
• mA Accuracy 10%
• mAs Accuracy (for version 1 series system) 10% + 0.2mAs
• Linearity Film mode < 0.18
• Reproducibility Coefficient of Variation (COV) < 0.045
• Measurement Basis for Technical Factors
kVp - The peak value of high voltage generator output in the interval after a 20 ms delay period to the
end of the exposure.
mA - The time average of the current flow into the high voltage cable/X-ray tube assembly, beginning
at the point where kVp crosses the 35 kVp level.
Time - Measurement of exposure time begins when the kVp crosses the 35 kVp level ( 80% of kVp
selected).
mAs - The time integral of mA as defined above.

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OEC One Mobile C-arm X-ray Product

9.3.2 X-ray Source Assembly


Inherent Filter 2.55 mm Al @50KV
Maximum continuous heat dissipation rate 177W
Tube assembly dimension (length x Width x Height) 327mm ×132 mm×238 mm
Tube assembly weight 17.5 kg
Maximum heat capacity 900,000HU
Maximum cooling rate 12,500HU/min
Cooling method Natural cooling
Maximum symmetrical radiation field on the X-axis 100cm from the spot:
Fluoro: 235 mm (diameter)
Film: 240mm (diameter)
Leakage radiation Dose rate is less than 0.88mGy/h, averaged
over any area of 100 cm2 of which no principal
linear dimension exceeds 20 cm at 1 m from
the focal spot under conditions of loading.
Leakage radiation test condition 110 kV, 2mA

Location of the focal spot and the reference axis

The reference axis is from the center of the


focal spot to the center of the image intensifier.
Focal spot’s tolerance on the reference axis is
zero.

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Technical Reference

X-ray tube
Nominal high voltage 110 kV
Nominal input power 2.2kW
Maximum anode heat capacity 53 kJ
Target material Tungsten
Target angle 10°
Small focal spot (Normal Fluoro, High Level Fluoro, 0.6×1.4 (IEC336)
Digital Spot)
Large focal spot (Film, Digital Spot) 1.4 (IEC336)
Anode Stationary
Typical filament specification 4.2V, 3.5A
Maximum filament current 4.6A
Permanent Filtration 0.55mm Al @50kV
Weight 0.65 kg
Manufacturer and model 110/3 DF
Maximum voltage between anode and ground 55kV
Maximum voltage between cathode and ground -55kV
X-ray radiation angle 10°
Bracket (between the tube assembly and the collimator)
Filter 0.8 mm Al
Collimator
Filtration 0 mm Al
Input power DC 5V, 1W
Electrical connection mode Through 3mm, 12pins connector
Mechanical connection mode Bracket, screw fitting
Iris collimator
Fluoroscopy nominal diameter: 23/16/12cm(9"/6"/4.5")
X-ray beam continuously adjustable to an area of less than 5×5cm at the image receptor
Film nominal diameter circle: 23cm(9")
Shutter collimator
Full Range Rotation Angle: 360°
Operation: by control panel
The total filtration
3.35 mm Al without removable filter
Removable filter: 3.5mm AI

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OEC One Mobile C-arm X-ray Product

9.3.3 Others
Grid
Type Circular
Focus distance 100 cm

Monitor
Type Widescreen with touchscreen
Size 27"
Central resolution (23XZ4ST/BS) 1920×1080

Image Intensifier
Input field size 9’’(23 cm) 6’’(16cm) 4.5’’(12cm)
Central resolution (23XZ4ST/BS) 52Lp/cm 58 Lp/cm 68 Lp/cm
Image Storage
Capacity 100,000 images
Image resolution 1K x 1K
Digital Processor
Function Negate, Edge Enhancement, Auto Brightness/
Contrast, Manual Brightness/Contrast Adjustment,
Rotation/Reversal/Invert, Smart Metal, Zoom/Roam,
Swap, Recursive Noise Reduction and Last Image
Hold

Fuse

Reference Position Technical reference

F3,F4,F5,F7,F8 Mother Board 1.25A,250V,Fast Acting

F1,F2,F6 Mother Board 2.5A,250V,Fast Acting

F6,F8 Power Management Unit 0.5A,250V,Time Delay

F2 System Interface Board 1A,250V,Time Delay

F1 System Interface Board 3.15A,250V,Time Delay

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Technical Reference

9.4 Tube Rating Chart


The following charts and data describe tube characteristics when operated with three-phase full-wave
rectification, a reasonable approximation to the high frequency generator with minimal ripple.

9.4.1 Filament Emission Characteristics

Small Focal Spot

Large Focal Spot

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OEC One Mobile C-arm X-ray Product

9.4.2 Single Load Ratings


Small Focal Spot

Large Focal Spot

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Technical Reference

9.5 Tube Thermal Characteristic


Anode Heating and cooling characteristics:
Oil temperature 40℃

Tube Housing heating and cooling characteristic:

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OEC One Mobile C-arm X-ray Product

9.6 Room Interface (RIF)


For detailed information, refer to Section 3.9.

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Technical Reference

9.7 Options
9.7.1 Laser Aimer
The laser aiming device produces a laser beam, which is used to indicate the central axis of the X-ray
beam. An opaque cross-hair located on the laser aimer provides a reference point in the X-ray image that
can be used in conjunction with the laser beam to obtain an accurate placement angle during alignment
procedures.
OEC One mobile C-arm X-ray Product provides two laser aimer options, which are attached to the tube
and image intensifier.

Image intensifier side Laser Aimer Tube side Laser Aimer

CLASS IIIa/3R laser product CLASS 1M laser product

Wavelength: 650 nm Wavelength: 637 nm

Optical output power: ≤5.0 mW Optical output power: ≤5.0 mW

Laser aimer, which is attached to the tube, is incorporated with the tube cover. Press the laser aimer’s ON
switch to generate the laser beam. The weight of generator’s laser aimer: 0.65±0.05kg.

Perform the following procedure to install and operate the laser aimer on the Image Intensifier. The C-arm
can be placed in any orientation that is convenient for attaching the laser aimer. There are no alignment
marks or notches on the laser aimer that need to match any points on the image intensifier. The weight of
the laser aimer on the image intensifier: 2.15±0.2kg.

When the laser aimer is attached to the C-arm, releasing the orbital or rotational brake
C A U T IO N
could cause the C-arm to move. Make sure to hold the C-arm to control its movement
whenever a brake is released.

1. Place the laser aimer’s attachment handle in the open position.


2. Move the laser aimer flush with the Image Intensifier, but slightly off center.
3. Center the laser aimer with the relation to the Image Intensifier. As you center the laser aimer, the
attachment hooks catch on the edge of the image intensifier.

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OEC One Mobile C-arm X-ray Product

4. Turn the attachment handle inward until the handle is completely closed and the laser aimer is securely
attached to the image intensifier. Insert the metal bolt into the hole of the handle to lock.

Do not grasp the Laser Aimer's handle to position the C-arm or to move the system. Pulling
C A U T IO N
the handle may cause the Laser Aimer to release from the image intensifier and fall.

5. Use the image intensifier handle to position the C-arm or to move the system to the desired location.
6. After attaching the laser aimer, place the C-arm in the position it will be used during the procedure.
7. Turn the laser aimer ON and adjust the beam alignment knobs until the laser beam is centered on the
crossing of the cross-hairs on the tube cover.
If the laser is ON, do not look directly into the laser aimer’s aperture.
C A U T IO N

8. Using fluoroscopy, position the cross-hairs in the Fluoro image, at the center of the area of interest.

The location where the laser beam marks the patient corresponds to the center of the area of
NOTE interest, indicated by the cross-hairs in the Fluoro image.

If you don’t want the cross-hairs to show on the image, remove the laser cover from the laser aimer.
1. Switch OFF the power to the laser aimer.
2. Grasp the two knobs on the laser cover.
3. Press down and rotate the cover (approximately 10 degrees counterclockwise) until the knobs align
with the notches on the housing.
4. Lift off the cover and resume laser aimer operation.
Regardless of efforts taken when using this device, attempts to adjust or operate the
WARNING equipment may result in harmful radiation.

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Technical Reference

9.7.2 30 cm Skin Spacer

Skin spacer is used to increase the distance of skin to X-ray focal spot, it can decrease the over radiation
risk.
The weight of Skin Spacer: 0.35±0.1kg. Skin spacer can be installed on the tube cover and removable
filter. Install the skin spacer using the following steps:
1. Put the skin spacer on the X-ray tube cover or removable filter. Make sure the skin spacer’s hole
superpose with the screws.
2. Rotate the skin spacer clockwise to lock it onto the cover.

9.7.3 Film Cassette Holder


Film is only available in version 1 series system.
NOTE

Film cassette holder dimension: 33.1cm x35.0cm x5.2cm for 9’’ Image Intensifier. The weight of the film
cassette holder: 1.35±0.1kg.
Film cassette dimensions: 10’’ x 12’’ (24 cm x 30cm) for 9’’ image intensifier.
If user needs to install the film cassette holder, please make sure the lock handle is locked into place.

9.7.4 Video Distributor

The video distributor provides a means of viewing the images on an external monitor.
The weight of the video distributor is 0.6±0.05kg.

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OEC One Mobile C-arm X-ray Product

The system provides video from monitor or the left area of the monitor to external monitor by the means of
video distributor.
The system video distributor provides DVI-I and BNC interfaces for external display devices.

The system video distributor outputs a DVI-D video signal with a resolution of 1920  1080 (16:9) and a
refresh rate of 60Hz through the DVI-I interface. External display devices are recommended to use the same
settings. under normal circumstances, the external display device display the same image. There are other
conditions as shown below.
1. If the external display device does not support the above resolution and refresh rate, the image on the
monitor may not be displayed properly.
2. If the external display device is a VGA interface, you must use a cable with a DVI-D to VGA transceiver,
otherwise the external display device will not be able to display the image on the monitor.
3. If the external display device supports the above resolution and refresh rate but it is not the non-
widescreen display device, the image will be compressed on the horizontal axis.
The system video distributor can output the left area video signal of the image on the monitor to the external
display device by NTSC / PAL format. Normally, the image on the external display device will be the same as
the left area of the image on the monitor. The video splitter support “NTSC / PAL" and
"16:9/4:3” video signal output for the external display device, the default setting is PAL/4:3 please call for
service to change the output settings.

9.7.5 Removable Grid


In some countries or regions, a removable grid is required to be used in pediatric or other medical
applications. Please use this option as requirement of local regulations. When user is conducting imaging
without a removable grid, system can obtain images with lower dose, but it may cause image blurring.
Image quality may be sub-standard.

Removable Filter Installation:


First, press the localizer bolt button, and remove the bolt from the handle, rotate the handle.
Install the removable grid on the image intensifier, and pay careful attention when installing the localizer
bolt, it should be located inside the grid holder.
Rotate the handle to lock the filter support, and insert the localizer bolt.
Removable Filter Uninstallation:
First, press the localizer bolt button, and remove the bolt from the handle, rotate the handle.

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Technical Reference

Remove the removable grid from the image intensifier.

9.7.6 Removable Filter


In some countries or regions, a removable filter is required to be used in pediatric or other medical
procedures. Please use this option as requirement of local regulations. Using the removable filter, will
reduce the dose radiation for the patient and technician. For the same parts imaging, the kVp and mA may
increase and tube sustainable exposure time may be shortened.
The removable filter includes two sensors and a 3.5 mm Al filter. The weight of the grid is 0.3±0.1kg.

9.7.7 Wireless Module


The system provides optional wireless means to connect to the Ethernet network with Wireless module.
The Wireless module works as a client device in OEC One, connecting to the hospital image archive server
or other RIS servers such as work list server by an access point device, or a router device which is provided
by hospital IT infrastructure. Other wireless client devices such as cellphone or laptop can’t be connected
to OEC One. The wireless technology used in OEC One is not used for transmission, reception, or process
involving alarm signals.
When using the wireless network, open the Wireless module on rear panel by wireless power switch, then
setup the wireless network. For detailed setup information, please refer to section “DICOM Setup”.

The Wireless Module comply with following countries regulations but not limited:
1. Wireless Module compliances with FCC requirements for operating in the United States and has been
tested and complies with the specifications for a Class B digital device, pursuant to Part 15 Subpart B
of the FCC Rules
2. Wireless Module compliances with Canadian Department of Communication Radio Interference
Regulations ICES-003 and RSS-247.
3. Wireless Module compliances with Regulations of State Radio Regulatory Commission of the People’s
Republic of China.

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OEC One Mobile C-arm X-ray Product

4. Wireless Module shall be compliance with the Essential Requirements and other relevant provisions of
Directive 2014/53/EU.
5. Wireless Module compliances with the Australia and New Zealand RCM certification.
6. Wireless Module compliances with Broadcasting and Communication Equipments of South Korea.
7. Wireless Module compliances with Certification of Radio Equipment in JAPAN.
8. Wireless Module compliances with Certification of Radio Equipment in Taiwan.
Technical Specifications:
Feature Description
Antenna 2 antennas
Standards 802.11a, 802.11n, 802.11g, or 802.11b
Radio data rate Auto Rate Sensing
FCC: 2.412 to 2.462 GHz (11 channels)
Operating frequency ranges – 2.4GHz
CE: 2.412 to 2.472 GHz  (13 channels)
FCC:
5.180 to 5.240 GHz (4 channels)
5.260 to 5.320 GHz  (4 channels)
5.500 to 5.700 GHz ( 8 channels, excluding 5.600 to 5.640 GHz)
Operating frequency ranges – 5 GHz 5.745 to 5.825 GHz  (5 channels)
CE:
5.180 to 5.240 GHz (4 channels)
5.260 to 5.320 GHz  (4 channels)
5.500 to 5.700 GHz (11 channels)
Power 12V,0.56A
Emissions FCC, CE
LAN 10/100/1000BaseT(X) auto negotiation speed, RJ-45
Operating environment Operating temperature: 0 to 60°C
64-bit and 128-bit WEP encryption,
Encryption WPA/WPA2-Personal
WPA/WPA2-Enterprise (IEEE 802.1X/RADIUS, TKIP, and AES)
Quality of Service (QoS) WiFI Multi-media (WMM)

To join a wireless network, select network name (also called the SSID) and enter correct user name and
passphrase. If the Wireless Module cannot connect to the network, the following information will display on
user interface: (SSID) Disconnected.
In this case, please try following trouble shooting methods to attempt to reconnect network:
• The user name and passphrase is case-sensitive, please confirm and retype the user name and

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Technical Reference

passphrase.
• Make sure the wireless module power switch is at “On” position.
• Make sure the router is turned on.
• Adjust system position.
• Use one greater wireless range router.
• Use a range extender to extend its wireless range to your location.
Separation distance of 20 cm or more should be maintained between this device and
NOTE persons during device operation. To ensure compliance, operations at closer than this
distance is not recommended. The antenna used for this transmitter must not be co-located
in conjunction with any other antenna or transmitter.

9.7.8 Wireless Switch


For detailed information, refer to Section 3.8.8.

9.7.9 Cine and DAS&Roadmap


For detailed information, refer to Section 3.8.10.

9.8 Material Recycling


Parts or accessories at end–of–life:
All materials and components that could have risks to the environment must be removed from the end–
of–life parts and accessories (For examples: transformer oil, batteries, etc).The disposing of parts and
accessories must be in accordance with national or local regulations for waste processing.
Please consult your local GEMS representative before discarding these products.
Packing materials:
The materials used to pack our equipment are recycled. They must be collected and processed in
accordance with the local regulations.

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OEC One Mobile C-arm X-ray Product

9.9 Replacement Parts


Parts as listed below can be replaced in the field. Call service to replace or maintain these parts.
• Circuit boards
• Cables
• Collimator
• Image Intensifier
• Camera
• Monoblock
• DC power supply, fuse, capacitor, filter, breaker and fuse
• Power on indicator and exposure indicator
• Monitor & Tablet
• Memory bank, mother board assembly, hard disk of computer
• Footswitch, handswitch and emergency switch
• Handles & wheels
• Covers
• Transformer
• Batteries

Never make any modifications or adjustments to the equipment unless directed by a GE


WARNING Healthcare authorized service engineer.

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OEC One Mobile C-arm X-ray Product

9.10 System Block

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