Senographe Pristina 3D - Pre-Installation Manual - PIM - 5754692-1-8EN - 2 PDF

Senographe Pristina™ 3D
Pre-Installation Manual
PIM
5754692-1-8EN
Revision 2
©
2016-2017 by General Electric Company All rights reserved.
Senographe Pristina 3D 5754692-1-8EN
Pre-Installation Manual Revision 2
This page is intentionally left blank.
Page no. 2 Cover_3D_PIM.fm

IMPORTANT...X-RAY PROTECTION
ATTENTION
Un appareil de radiographie peut provoquer des accidents corporels s’il n’est pas utilisé de
manière appropriée. En conséquence, il incombe à son propriétaire de s'assurer que les
instructions contenues dans ce document sont entièrement lues et comprises par toute personne
qui sera amenée à utiliser cet appareil, avant toute tentative de mise en service. General Electric
Company, Healthcare Technologies, se tient à disposition pour toute assistance ou collaboration
nécessaires lors de la mise en service de cet équipement.
Même si cet appareil incorpore certaines protections sophistiquées contre les rayons X en
dehors du faisceau utile, aucune conception pratique ne peut assurer une protection totale
contre toutes les blessures possibles. De même, aucune conception pratique ne peut obliger
l’opérateur à prendre les précautions nécessaires pour éviter que des personnes ne s’exposent
par négligence aux rayons X.
Il est essentiel que toute personne devant manipuler un appareil de radiographie soit
correctement formée à cet effet, et connaisse parfaitement les recommandations du National
Council on Radiation Protection and Measurements telles que publiées dans les rapports du
NCRP disponibles auprès de NCRP Publications, 7910 Woodmont Avenue, Room 1016,
Bethesda, Maryland 20814, et de la Commission internationale de protection contre les
rayonnements. Il incombe au propriétaire de l'appareil de prendre toutes les mesures
nécessaires contre les risques de blessures.
General Electric Company, Healthcare Technologies, ses agents ou ses représentants ne
pourront être tenus pour responsables des préjudices matériels ou corporels découlant d’une
utilisation inappropriée de l’appareil. Divers équipements et dispositifs de protection sont
disponibles. Leur utilisation est vivement recommandée, conformément aux pratiques cliniques
de l'établissement.
CAUTION
If not properly used, x-ray equipment may cause injury. Accordingly, it is your obligation to confirm
that the instructions herein contained are thoroughly read and understood by everyone who will use
the equipment before you attempt to place this equipment in operation. The General Electric
Company, Healthcare Technologies, will be glad to assist and cooperate in placing this equipment in
use.
Although this apparatus incorporates a high degree of certain protections against x-radiation other
than the useful beam, no feasible design of equipment can provide complete protection from all
potential injury. Nor can any feasible design force the operator to take adequate precautions to
prevent the possibility of any persons carelessly exposing themselves or others to radiation.
It is important that anyone having anything to do with x-radiation be properly trained and fully
knowledgeable about the recommendations of the National Council on Radiation Protection and
Measurements as published in NCRP Reports available from NCRP Publications, 7910 Woodmont
Avenue, Room 1016, Bethesda, Maryland 20814, and of the International Commission on Radiation
Protection. It is your obligation and responsibility to take adequate steps to protect against injury.
The equipment is sold with the understanding that the General Electric Company, Healthcare
Technologies, its agents, and representatives have no responsibility for injury or damage, which may
result from improper use of the equipment. Various protective materials and devices are available. It is
urged that such materials or devices be used in accordance with your site’s clinical practice.
radiation warning.fm Page no. 3


CUIDADO
Si no se utilizan correctamente, los equipos de rayos X pueden causar lesiones. En consecuencia, es su

responsabilidad asegurarse de que cualquier persona que utilice este equipo haya leído y comprendido
las instrucciones que contiene el presente manual antes de poner el equipo en funcionamiento. El grupo
Healthcare Technologies de la General Electric se complacerá en ayudarle a poner este equipo en
funcionamiento.
Aunque este aparato incorpora un alto grado de protección contra la radiación de los rayos X distinta de la
procedente del haz útil, no existe ningún equipo cuyo diseño ofrezca una protección completa contra
todas las lesiones posibles. Tampoco existe ninguna forma de obligar al operador a adoptar las medidas
de precaución adecuadas para evitar la posibilidad de que alguna persona se exponga accidentalmente a
sí mismo o exponga a otras personas a la radiación.
Es importante que toda persona en contacto con la radiación X reciba una formación adecuada y que
conozca perfectamente las recomendaciones del Consejo nacional para la protección y las medidas
contra la radiación (NCRP), publicadas en los Informes del NCRP, disponibles ante NCRP
Publications, 7910 Woodmont Avenue, Room 1016, Bethesda, Maryland 20814, y de la Comisión
internacional sobre protección contra la radiación. Es su obligación y responsabilidad tomar las
precauciones necesarias para evitar posibles lesiones.
Este equipo se vende con la condición explícita de que el grupo Healthcare, de General Electric, sus
agentes o sus representantes declinan toda responsabilidad por lesiones o daños causados por una
utilización incorrecta del equipo. Existen distintos materiales y dispositivos de protección disponibles.
Le instamos a que los utilice conforme a la práctica clínica de su centro.
VORSICHT
Die unsachgemäße Verwendung von Röntgengeräten kann Verletzungen verursachen. Deshalb hat
der Betreiber dafür Sorge zu tragen, dass alle Personen, die dieses System verwenden werden, vor
dessen Inbetriebnahme die in diesem Dokument enthaltenen Anweisungen gelesen und verstanden
haben. Die General Electric Company, Healthcare Technologies, leistet gerne die für den Einsatz der
Anlage erforderliche Hilfe und Unterstützung.
Obwohl dieses Gerät über einen hochgradigen Schutz gegen über den Nutzstrahl hinausgehende
Röntgenstrahlen verfügt, ist zu beachten, dass kein machbares Systemdesign einen vollständigen
Schutz vor jeglichen möglichen Verletzungen/Gesundheitsschäden bieten kann. Auch kann die
optimale Konstruktion der Anlage den Benutzer nicht von der Verpflichtung entbinden, die
entsprechenden Vorkehrungen zu treffen, um die Möglichkeit einer unbeabsichtigten oder unbemerkten
Strahlenexposition von berechtigten bzw. unberechtigten Personen durch direkte Strahlung oder
Streustrahlung zu verhindern.
Es ist absolut notwendig, dass jeder, der mit Röntgenstrahlung zu tun hat, ordnungsgemäß
ausgebildet ist und die vom National Council on Radiation Protection and Measurements
(veröffentlicht in den NCRP-Berichten, die bei NCRP Publications, 7910 Woodmont Avenue, Room
1016, Bethesda, Maryland 20814 erhältlich sind) und von der International Commission on Radiation
Protection vorgegebenen Auflagen erfüllt. Der Anwender ist verpflichtet, adäquate Maßnahmen zum
Schutz vor Verletzungen/Gesundheitsschäden zu treffen.
Die Anlage wurde unter der Voraussetzung verkauft, dass die General Electric Company, Healthcare
Technologies, ihre Vertreter und Beauftragten nicht für Verletzungen oder Schäden haften, die auf
einen unsachgemäßen Einsatz der Anlage zurückzuführen sind. Es stehen verschiedene
Schutzausrüstungen und -geräte zur Verfügung. Es ist dringend erforderlich, dass diese Ausrüstungen
und Materialien gemäß der klinischen Praxis am Standort eingesetzt werden.
Page no. 4 radiation warning.fm

Language Warning
Language Warning
ПРЕДУПРЕЖДЕНИЕ Това упътване за работа е налично само на английски и френски

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和法文版本。
(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和法語版本。
(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和法文版。
(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。
UPOZORENJE Ovaj servisni priručnik dostupan je na engleskom i francuskom jeziku.
• Ako davatelj usluge klijenta treba neki drugi jezik, klijent je dužan osi-
(HR) gurati 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.
language warning.fm Page no. 5


Language Warning
VÝSTRAHA Tento provozní návod existuje pouze v anglickém a francouzském jazyce.

• V případě, že externí služba zákazníkům potřebuje návod v jiném
(CS) 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.
ADVARSEL Denne servicemanual findes kun på engelsk og fransk.
• Hvis en kundes tekniker har brug for et andet sprog end engelsk, er
(DA) 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 en het Frans
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.
WARNING This service manual is available in English and French only.
• If a customer's service provider requires a language other than
(EN) 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.
HOIATUS See teenindusjuhend on saadaval ainult inglise ja prantsuse keeles.
• Kui klienditeeninduse osutaja nõuab juhendit inglise keelest erinevas
(ET) 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.
Page no. 6 language warning.fm

Language Warning
VAROITUS Tämä huolto-ohje on saatavilla vain englanniksi ja ranskaksi.

• Jos asiakkaan huoltohenkilöstö vaatii muuta kuin englanninkielistä
(FI) 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 uniquement disponible en
anglais et en français.
(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 Wartungsanweisung liegt nur in englischer und französischer
Sprache vor.
(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.
ΠΡΟΕΙΔΟΠΟΙΗΣΗ Το παρόν εγχειρίδιο σέρβις διατίθεται μόνο στα αγγλικά και γαλλικά.
• Εάν ο τεχνικός σέρβις ενός πελάτη απαιτεί το παρόν εγχειρίδιο σε
(EL) 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 és francia nyelven érhető el.
• Ha a vevő szolgáltatója angoltól eltérő nyelvre tart igényt, akkor a vevő
(HU) 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.


Language Warning
AÐVÖRUN Þessi þjónustuhandbók er aðeins fáanleg á ensku og frönsku.

• Ef að þjónustuveitandi viðskiptamanns þarfnast annas tungumáls en
(IS) 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 e francese.
(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.
警告このサービスマニュアルには英語版とフランス語版しかありません。
(JA) • サービスを担当される業者が英語以外の⾔語を要求される場合、翻訳
作業はその業者の責任で⾏うものとさせていただきます。
• このサービスマニュアルを熟読し理解せずに、装置のサービスを⾏わ
ないでください。
• この警告に従わない場合、サービスを担当される⽅、操作員あるいは
患者さんが、感電や機械的⼜はその他の危険により負傷する可能性が
あります。
경고 본 서비스 매뉴얼은 영어와 프랑스어로만 제공됩니다 .
(KO) • 고객의 서비스 제공자가 영어 이외의 언어를 요구할 경우 , 번역 서비
스를 제공하는 것은 고객의 책임입니다 .
• 본 서비스 매뉴얼을 참조하여 숙지하지 않은 이상 해당 장비를 수리하
려고 시도하지 마십시오 .
• 본 경고 사항에 유의하지 않으면 전기 쇼크, 기계적 위험, 또는 기타 위
험으로 인해 서비스 제공자 , 사용자 또는 환자에게 부상을 입힐 수 있
습니다 .
BRDINJUMS Šī apkopes rokasgrāmata ir pieejama tikai angļu un franču valodā.
• Ja klienta apkopes sniedzējam nepieciešama informācija citā valodā,
(LV) 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.
ĮSPĖJIMAS Šis eksploatavimo vadovas yra tik anglų ir prancūzų kalba.
• Jei kliento paslaugų tiekėjas reikalauja vadovo kita kalba – ne anglų,
(LT) 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.

Language Warning
ADVARSEL Denne servicehåndboken finnes bare på engelsk og fransk.

• Hvis kundens serviceleverandør har bruk for et annet språk, er det
(NO) 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
i francuskim.
(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.
ATENÇÃO Este manual de assistência técnica encontra-se disponível unicamente
em inglês e francês.
(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 e
em francês.
(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 şi franceză.
• Dacă un furnizor de servicii pentru clienţi necesită o altă limbă decât
(RO) 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.


Language Warning
ОСТОРОЖНО! Данное руководство по техническому обслуживанию представлено

только на английском и французском языках.
(RU) • 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 i francuskom
jeziku.
(SR) • Ako klijentov serviser zahteva neki drugi jezik, klijent je dužan da obez-
bedi prevodilačke usluge.
• Ne pokušavajte da opravite uređaj ako niste pročitali i razumeli ovo
servisno uputstvo.
• Zanemarivanje ovog upozorenja može dovesti do povređivanja servi-
sera, rukovaoca ili pacijenta usled strujnog udara ili mehaničkih i dru-
gih opasnosti.
UPOZORNENIE Tento návod na obsluhu je k dispozícii len v angličtine a Francúzštine.
• Ak zákazníkov poskytovateľ služieb vyžaduje iný jazyk ako angličtinu,
(SK) 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 y francés.
• Si el encargado de mantenimiento de un cliente necesita un idioma
(ES) 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 och franska.
• Om en kunds servicetekniker har behov av ett annat språk än
(SV) 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.

Language Warning
OPOZORILO Ta servisni priročnik je na voljo samo v angleškem in francoskem jeziku.

• Če ponudnik storitve stranke potrebuje priročnik v drugem jeziku, mora
(SL) 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.
DIKKAT Bu servis kılavuzunun sadece ingilizcesi ve fransızcası mevcuttur.
• Eğer müşteri teknisyeni bu kılavuzu ingilizce dışında bir başka
(TR) 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.


Language Warning

IMPORTANT...X-RAY PROTECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Language Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Chapter 1. Publication Presentation

1. Scope and Applicability of the Publication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2. Content of this Publication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2-1. Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2-2. Publication Presentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2-3. Descriptive Chapters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2-4. Procedural Chapters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2-4-1. Service Contexts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2-4-2. Procedural Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2-4-3. Job Card and Scenario Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3. Publication Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3-1. Typographical Convention. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3-2. Entering and Typing Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4. Accessing Technical Publications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4-1. How to access electronic versions of Technical Publications on a dedicated GE website
20
5. Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Acronyms Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Senographe Pristina 3D Labels and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
1. Senographe Pristina 3D Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
2. Meaning of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Chapter 2. Safety
1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2. Definition of Warnings and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3. Use of Personal Protective Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Chapter 3. System Description

1. Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
2. 3D Option Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
3. Product Locator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4. System software release history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
5. 3D User Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
5-1. AutoPush Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
5-2. Acquisition Preferences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
5-3. AutoDelete Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
6. Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
6-1. Component Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
6-2. Senographe Pristina 3D Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
TOC_PIM 3D.fm Page no. 13

Chapter 4. Pre Installation System Requirements

1. About this Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
2. Planning for Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
2-1. Temporary Storage in the Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
2-2. Packing Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
3. Interoperability and Networking Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
3-1. DICOM Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
3-2. Storage Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
3-3. Networking Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4. Associated Review Workstations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5. PACS Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Page no. 14 TOC_PIM 3D.fm

Publication Presentation
Chapter 1 Publication Presentation
1 Scope and Applicability of the Publication

This Service publication provides all information required to understand, to plan installation, to install,
and to maintain the Senographe Pristina 3D option.
This publication contains only class A information.
It is intended for use by Field Engineers installing and maintaining the system who are employed by:
• GEMS.
• A third party supplier with an agreed contract with GE.
• A third party supplier without an agreed contract with GE.
This manual is provided for and is specific to the Senographe Pristina 3D option. The Senographe
Pristina Service Manual remains applicable to the Senographe Pristina 3D option for all features and
functions not described in this Service Manual.
For information on associated equipment mentioned in this publication, such as the review workstation,
refer to their specific publications.
The manual describes the use of the Senographe Pristina 3D option in its most complete configuration.
Note:
Due to regulatory or legal restrictions, not all options are available in all countries or locations.
To find out if a particular option or accessory is available in your country, contact your local GE
Sales representative.
2 Content of this Publication

2-1 Safety Information
• The Safety chapter gives regulatory warnings which must be read and understood before reading the
documentation and using the equipment.
2-2 Publication Presentation

• The Publication Presentation chapter describes the content of the publication and explains how to
navigate within it.
2-3 Descriptive Chapters

• Descriptive chapters give information required to understand the equipment, together with reference
information:
- System Description gives a physical and operational description of the system. It includes
functional diagrams, FE operations, component and FRU location, and a component index.
- System Identification and Follow-up gives system configuration and service history information.
- Pre-Installation System Requirements specifies site planning requirements.
2-4 Procedural Chapters

2-4-1 Service Contexts
• Procedural chapters describe procedures required in specific service contexts:
- Pre-installation.
Publication Presentation_PIM.fm Page no. 15 Chapter 1


- Physical Installation.
- Electrical Installation.
- Upgrade Procedures.
- Planned Maintenance.
• Installation and Planned Maintenance procedures assume that no equipment failure occurs. If an
equipment failure occurs, the FE must refer to corrective maintenance procedures.
2-4-2 Procedural Instructions
• Procedural instructions are given in three types of document: Error message lists, Scenarios, and
Job Cards:
2-4-2-1 Error Message Lists
• Error message lists document messages intended for the FE. These messages can be displayed on
screen, on dedicated display panels, or stored in an error log
• Specified or suggested corrective actions are listed. These can include hypertext links to relevant Job
Cards.
2-4-2-2 Scenarios
• A scenario is a high-level description of the steps required to carry out a defined Service action, such
that:
- The context is perfectly known.
- The initial state and the final state are perfectly known.
• All the steps are identified, including preparation steps (pre-requisites) and finalization steps (post -
requisites). The steps are defined in Job Cards.
• The sequencing (order) of the steps is exactly defined. However, there can be alternative
(conditional) paths in the sequence.
• Scenarios contain two sections:
- Context: explains the circumstances in which the scenario must be performed.
- Steering guide: gives the exact sequence of jobs to be performed, in a tabular format.
2-4-2-3 Job Cards
• Job Cards are used to describe specified independent tasks (e.g., the installation of a specific
component, a calibration procedure, etc.).
• Job Cards include all instructions required to carry out the specified task. These can include
instructions to perform other Job Cards.
• The same Job Card can be used in different contexts. For example, a Job Card specifying a
calibration procedure can be carried out during installation, or after changing a component.
Chapter 1 Page no. 16 Publication Presentation_PIM.fm

2-4-3 Job Card and Scenario Categories

Category definition Scope JC SC
code code
Pre-installation Includes wall, ceiling, and floor preparation, electrical PRE PRE
cabling, etc.
System Physical Installation First installation on Customer site – Physical IST IST
installation step = without powering-on the equipment.
System Electrical Installation First installation on Customer site ELE ELE
Starts with powering on the system – ends with
cleaning the equipment, the room, and putting all into
order.
Configuration (HW & SW), Describes procedures for configuration of hardware CFG N/A
and/or software. Restore procedures are considered as
configuration; JCs describing backup and restore are
also classified as CFG.
Calibrations and Describes calibration and adjustment procedures. CAL N/A
adjustments
Diagnostics Used when a problem has been identified, and it is DIAG N/A
= diagnose only required to locate the root cause or to choose between
different root causes. May also be used to describe the
use of diagnostic software tools.
Trouble shooting Gives general guidance for a diagnostic and repair TSG N/A
= diagnose + repair strategy in a certain context (i.e., a certain combination
of symptoms).
Disassembly/Reassembly Describes removal and reinstallation of a component or D/R N/A
assembly. Does not usually include calibration and
verification procedures, but points to them.
Planned Maintenance Specifies planned maintenance procedures and their PM PM
frequency.
3 Publication Conventions
3-1 Typographical Convention
• In text describing the user interface, italic and bold characters differentiate between body text and on-
screen or hardware captions and labels, entered text, etc.:
- Italics are used for references to hardware items and text which appears on-screen (e.g., menu
titles, button labels, on-screen messages, etc.).
- Bold face is used when specific instructions are given for the entry of text or selection of a menu
option, etc.
• In text describing the command line interface (CLI), italic and bold courier characters are used to
differentiate between body text and the command line:
- Italics are used for references to filenames and directory paths.


- bold courier face is used when specific commands are entered at the command line.
• In other text:
- Italics are used when a specific concept is introduced.
- Italic and bold characters can also be used for local emphasis.
- Blue italics are used for cross references.
3-2 Entering and Typing Instructions

Depending on the situation, you are instructed to either enter or type a command or string of text.
If you are instructed to enter a command or string of text, it means that you have to press the <Return>
key after typing that command or string of text. For example, in a CLI you are instructed as follows:
Move to the temp directory, by entering:
cd temp
If you are instructed to type a command or string of text, it means that you do not have to press the
<Return> key after typing that command or string of text. You are instructed to type, in the following
cases:
- typing a menu option in a CLI which does not require you to press the <Return> key
- field entries in a graphical user interface (GUI)
For example, to specify your name in a GUI field you are instructed as follows:
Type your first name in the First Name field.
or
Type 192.168.0.5 in the IP Address field.

Illustration 1 -


4 Accessing Technical Publications

4-1 How to access electronic versions of Technical Publications on a dedicated GE
website
Each System is shipped with User and Service Technical Publications. These Technical Publications are
available for download on a dedicated GE Website.
Consult the Release Letter shipped with your system to obtain a list of all Technical Publications and
Software versions applicable to the System.
Release Letters contain all the Part Numbers for Technical Publications related to your System.
Always use the version of the Release Letter marked "New" on the website.
The Technical Publications Release Letter for this system is 5776078-899.
This Pre-Installation Manual and all other Technical Publications related to this Medical Device are
available on the Internet at:
http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library.
1. Search for and download the Release Letter.
a. Go to http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library.
b. Enter 5776078-899 in the search field and click [Search].
c. Click on the underlined Filename.
d. In the Copyright window, click [ACCEPT].
e. Follow the instructions on the website to open or save the file.
f. In the Release Letter, search for the required Technical Publication (For example, Pre-Installation
Manual).
g. Copy the Part Number from the relevant cell. (For example, 5754692-1-8EN)
2. Search for and download the Technical Publication.

a. Go back to:
http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library.
b. Enter 5754692-1-8EN in the search field and click [Search].
c. Click on the underlined Filename.
d. In the Copyright window, click [ACCEPT].
e. Follow the instructions on the website to open or save the file.
5 Revision History
This table is intentionally left in English.
Reference Date Designation

5754692-1-8EN_r2 2017 Resolution of the following SPR:
HCSDM00436648: correction of PNs for 3D OM and 3D QC, and
modification of the disclaimer
5754692-1-8EN_r1 2016 First release

Acronyms Glossary
Acronyms Glossary
A
AC Alternating Current
ACR American College of Radiology
ADU Analog to Digital Unit (or "count")
AGD Average Glandular Dose
AOP Automatic Optimization of Parameters
ARC Analog Readout Chip
AWS Acquisition Workstation
AXIS Name given to the Computer in the Control Station
B
BNU Brightness Non Uniformity
BPA Bisphenol A
C
CC CranioCaudal
CESM Contrasted Enhanced Spectral Mammography
CF Conversion Factor
CNR Contrast
Csl Cesium Iodide
CTQ Critical to Quality
D
DBT Digital Breast Tomosynthesis
DC Direct Current
DICOM Digital Imaging and Communications in Medicine
DQE Defective Quantum Efficiency
E
ESAK Entrance Skin Air Kerma
ESE Entrance Skin Exposure
EUREF European Reference Organization for Quality Assured Breast Screening and Diagnostic
Services
F
FDA Food and Drug Administration
FE Field Engineer
FOV Field Of View
FRU Field Replaceable Unit
Acronym-Glossary.fm Page no. 21


Acronyms Glossary
G
GEN Generator
GUI Graphical User Interface
H
HFM High Frequency Modulation
HVL Half Value Layer
I
IDC Image Detection Controller
IEC International Electrotechnical Commission
IFF Image Feedback Function
IM Installation Manual
IQ Image Quality
IQST Image Quality Signature Test
J
JC Job Card
K
kV kiloVolt
kVp kiloVolt peak
L
LF Large Focal Spot
LFOV Large Field Of View
LRS Long Range Scatter
LSB Least significant bit
LSL Lower Specification Limit
LUT Look Up Table
M
mA milliAmpere
mAs milliAmpere per second
MG DICOM code for Mammography Modality
MLO MedioLateral Oblique
Mo Molybdenum
MPC Medical Procedure Card
MQSA Mammography Quality Standards Act
MTF Modulation Transfer Function
Page no. 22 Acronym-Glossary.fm

Acronyms Glossary
N
N/A Not Applicable
NPS Noise Power Spectrum
O
OLC OnLine Center
OM Operator Manual
OME Operator Manual Extract
OPET Overall Pre-Exposure Time
OS Operating System
PIM Pre-Installation Manual

PMMA PolyMethyl MethAcrylate
PN Part Number
PPS Performed Procedure Step
PM Planned Maintenance
Q
QAP Quality Assurance Procedures
QC Quality Control
QG Quick Guide
QIF Quantum Improvement Factor
R
RAC Risk Assessment and Control
Rh Rhodium
RoHS Restriction of Use of Hazardous Substances
ROI Region Of Interest
RRA Repeat and Reject Analysis
RWS Review Workstation
S
SDNR Signal Difference to Noise Ratio
SF Small Focal Spot
SID Source to Image Distance
SIP Service Information and Procedures
SM Service Manual
SNR Signal to Ratio Noise
SPS Scheduled Procedure Step
Acronym-Glossary.fm Page no. 23


Acronyms Glossary
T
Tp Transmission of Primary Radiation
Ts Transmission of Secondary Radiation
U
UID Unique IDentifier
UDI Unique Device Identifier
USL Upper Specification Limit
Page no. 24 Acronym-Glossary.fm

Senographe Pristina 3D Labels and Symbols
1 Senographe Pristina 3D Labels

The Senographe Pristina 3D option includes two specific labels.
The Identification label (Illustration 2) and the UDI label (Illustration 3) are located on the label plate on
the left hand side of the Gantry.
Illustration 2 - Senographe Pristina 3D Identification label
Illustration 3 - UDI label for Senographe Pristina 3D
For more information on how to fix the Senographe Pristina 3D option labels, see Job Card IST A004 -
Fix the Senographe Pristina 3D option labels in the Senographe Pristina 3D Service Manual.
Each intervention (installation, corrective or planned maintenance) on a UDI labeled component must be
debriefed as per the local FE debriefing process.
To get a complete list of UDI labeled components present on the system, check the label plate (see Job
Card IST A004 - Fix the Senographe Pristina 3D option labels, section 7, Step 2. in the Senographe
Pristina 3D Service Manual).
2 Meaning of symbols
See section Meaning of Symbols in the Senographe Pristina Service Manual.
Meaning symbols.fm Page no. 25


Page no. 26 Meaning symbols.fm

Safety
Chapter 2 Safety
1 Introduction
This chapter contains information and warning related to safety.
For safety information regarding the System refer to the Safety chapter in the Senographe Pristina
Service Manual.
Medical device.
Ensure that the system is cleaned according to system hygiene procedures before performing
any service procedures.
Risk of falling mass and crushing injuries.

To prevent the risk of severe injury from a falling object, always remove the Face Protection
Shield before inserting or removing the Bucky. Removing the Face Protection Shield will also
prevent the risk of cuts, scrapes or crushing injuries to fingers or hands.
To avoid the risk of degraded image quality, before locking the Breast Support into place, check
that there is no small object that would prevent good contact between the Breast Support and the
cover.
To avoid any risk of pinched fingers during installation of the Bucky, slide the Bucky onto the rails
and push it rearward by pressing on its front side until the locking motor starts. During the
automatic locking phase, keep hands away from the moving part (Bucky) and Image Detector
cover. In an emergency, to stop the automatic locking or unlocking of the Bucky, briefly press on
either of the Breast Support release buttons. The Bucky can then be removed by simultaneously
pressing both Breast Support release buttons.
To avoid damaging the image receptor, always ensure that there is a Flat Field Phantom in place
before performing an exposure. Exposures without an IQ tool to absorb the X-rays may damage
the image receptor.
Senographe Pristina 3D uses a special high-precision anti-scatter grid in order to optimize the
image quality when performing 2D and 3D exposures. When inserting or removing the Bucky,
take care to protect it and the built-in anti-scatter grid from physical shocks that could damage it,
or affect the grid positioning. A misaligned grid may cause image quality degradation. In case of
doubt, perform the Texture Test to ensure that the image quality has not been affected. This test
can also be performed monthly.
Safety.fm Page no. 27 Chapter 2


Safety
2 Definition of Warnings and Notes
Indicates an imminently hazardous situation that, if not avoided, will result in death or serious
injury.
Indicates a potentially hazardous situation that, if not avoided, could result in death or serious
injury.
Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate
injury.
Used for instructions to the Operator to prevent damage to property.

Note:
Used to draw attention to information that is important for the Operator to know.
3 Use of Personal Protective Equipment

Throughout this Service Manual there are procedures that require you wear appropriate Personal
Protective Equipment (PPE). When reading the procedures pay special attention to the risks quoted in
the Danger, Warning, and Caution messages, and wear appropriate PPE (e.g. safety shoes, gloves, and
goggles) according to the nature of the risk involved.
Chapter 2 Page no. 28 Safety.fm

System Description
Chapter 3 System Description
1 Overview
All of the characteristics of the Senographe Pristina 3D option including range(s), accuracy, and
precision of displayed values can be found in the Specifications chapter of the Senographe Pristina 3D
Operator Manual.
Note:
Due to regulatory or legal restrictions, not all options are available in all countries or locations.
To find out if a particular option or accessory is available in your country, contact your local GE
Sales representative.
2 3D Option Components
In order for 3D option to be possible, an existing Senographe Pristina system must be upgraded with the
following components:
• Reconstruction Computer housed in the Control Station next to the AXIS Computer.
• A set of cables necessary to connect the Reconstruction Computer to ground and power, and a
cable to connect the AXIS Computer to the Reconstruction Computer. See section 6 Parts.
• Reconstruction Software (OS and application) to be installed on the Reconstruction Computer
• Universal face shield to replace the Standard face shield.
Illustration 7 Reconstruction Computer within the Control Station and Illustration 8 Universal Face Shield
on Gantry summarize the majority of the physical components required to enable 3D functionality on a
Senographe Pristina system.
3 Product Locator
Senographe Pristina is delivered with Product Locators Cards (PLC) that must be returned at installation
and FRU replacement.
Core System and Components
5582323 Senographe Pristina Core System
5543002 X-Ray Collimator
5505708 X-Ray Tube Assembly Artemis
5505894 DJINN Mammo Generator
5554855 Mammo N2M HVTank
5589268 DJINN Mammo Power Module
5505520 DJINN Mammo Auxiliary Module
5653880 Mag Stand 1.8 CDRH
5653882 Mag Stand 1.5 CDRH
5692261 Bucky Elixir CDRH
5692265 Detector CDRH
3D Option
5582318 Senographe Pristina 3D option
5582318-JA Senographe Pristina 3D Japan
System Description.fm Page no. 29 Chapter 3


System Description
Self-Compression
5727669 Self-Compression Solution
4 System software release history

The components in the Senographe Pristina 3D option must be at a certain version of firmware or
software in order to work correctly at system level.
The Release Letter 5776078-899 shipped with this system contains the system software/firmware
release history.
See section 4. Accessing Technical Publications on page 25 to download this Release Letter.
5 3D User Parameters
5-1 AutoPush Preferences
When the 3D medical procedure is activated on the system 3 additional types of image can be candidate
for auto-push: raw images, slabs and planes.
Illustration 4 - AutoPush preferences
5-2 Acquisition Preferences

When at least one additional routine medical procedure license is activated on the System, e.g. 3D, the
Medical Procedure Preferences are enabled on the system.
Through these preferences, the user can choose which medical procedure should be launched by
default when clicking the Start Exam button in the Patient Information Card (PIC) corresponding to the
selected Scheduled Procedure Step (SPS) in the Worklist.
When the 3D medical procedure is activated on the system, the user can choose his default preferred
sub-mode for AOP acquisition as for 2D acquisitions.
Chapter 3 Page no. 30 System Description.fm

System Description
Illustration 5 - Acquisition preferences
Activation of the 3D license also triggers the apparition of the third Acquisition Preferences tab Physicist
only in which the user can choose to acquire the 9 consecutive projections of a tomographic acquisition
with the same angulation.
Illustration 6 - Acquisition preferences
5-3 AutoDelete Preferences

When the 3D medical procedure is activated on the system, the user can choose his default preferred
behavior regarding projections deletion.
Note:
The projections of a same acquisition cannot be deleted separately, only altogether, whereas
planes and slabs can.


System Description
6 Parts
6-1 Component Index
This chapter describes the parts supplied with the Senographe Pristina 3D option.
The parts that can be ordered on the field for replacement are listed in the table below.
Consult the Component Index when you check the kits for damage.
If one of the kit part is damaged, check the FRU column to determine if Yes or No the part is a FRU.
• If the FRU column says Yes (FRU), order the kit part.
• If the FRU column says No (Not FRU), reorder the kit part
See the FRU/Component Index in the Senographe Pristina Service Manual for more information on the
Component Index and the table entries.
Class Part description Reference Comp. Loc Cabl D/R FRU
Senographe Pristina 3D option 5582318 N
25 Reconstruction Computer 5561820 Loc page 33 See Job Card Y
D/R A001 -
Reconstruction
Computer in
Senographe
Pristina 3D SM
45 3D option cable kit 5582798 Y
• AC Multiplug to
Reconstruction See Job Card
Loc page 93 page 67 D/R A001 -
Computer(W1314) in the in the
• Gigabit Ethernet Cable Reconstruction
Senographe Senographe Computer in
(W1128) Pristina 3D Pristina 3D Senographe
• Protective Earth Cable SM SM
from Control Station to Pristina 3D SM
Reconstruction Computer
Grounding Point (W1530)
85 Universal face shield 5589744 Loc Y
page 34
125 UDI Label Component 5725094 Loc page 99 N
in the
Senographe
Pristina 3D
SM
125 Identification label 5731565 Loc page 99 N
Senographe Pristina 3D in the
option Senographe
Pristina 3D
SM
Set of Technical Publications 5731565 N
for Senographe Pristina 3D

System Description
Class Part description Reference Comp. Loc Cabl D/R FRU

135 Reconstruction Computer See Y
software kit Release
Note: Letter
Download Release 5776078-
Letter 5776078-899 899
to access software
release history and
select the
Reconstruction
Computer Software
kit compatible with
your current system
release.
6-2 Senographe Pristina 3D Components

Illustration 7 - Reconstruction Computer within the Control Station
Reconstruction Computer
Control Station


System Description
Illustration 8 - Universal Face Shield on Gantry
Universal Face Shield

Pre Installation System Requirements
Chapter 4 Pre Installation System Requirements
1 About this Chapter

The following pre installation requirements are specific to the option:
• Planning for Storage
• Interoperability and Networking Connections
• Associated Review Workstations
• PACS Compatibility
The following requirements are common between Senographe Pristina and Senographe Pristina 3D.
They can be found in the Pre-Installation System Requirements chapter in the Service Manual:
• Environmental Requirements
• IEC60601-1-2 Electromagnetic Standards Compliance
• Noise
• Structural requirements
• Electrical requirements
• Door lights and safety switch
• Lighting
• Planning for radiation protection
• Room Layout Planning
• Insite Connection
• Networking Connections and Broadband Access
• Malicious Software Protection
2 Planning for Storage

2-1 Temporary Storage in the Hospital
There is normally a short delay (e.g., overnight) between the delivery of the equipment and its
installation.
If this delay lasts for more than two days, it is essential that a suitable storage room is available to
receive the equipment in its crates.
Refer to the Environmental Requirements section in the Pre-Installation Manual section of the
Senographe Pristina Service Manual for information on the environmental requirement.
2-2 Packing Information

Table 1 lists the dimensions and mass of shipping crate for the Senographe Pristina 3D option.
Table 1 - Shipping Dimensions and Masses
Item Dimensions in mm (inches) Mass in kg (lbs)
Depth Width Height
Pallet 1,010 760 742 50
(39.7) (29.9) (29.2) (110.2)
Pre Installation.fm Page no. 35 Chapter 4


3 Interoperability and Networking Connections

The DICOM committee has defined a dedicated DICOM standard format, called DICOM Breast
Tomosynthesis Object (BTO), to store the breast 3D volume data.
The Senographe Pristina 3D option implements this format.
As Tomosynthesis generates more data for each exam than conventional mammography, a larger
archiving capacity is required.
Therefore, integrating the Senographe Pristina 3D option to an existing workflow implies to check:
• the DICOM compatibility of other systems (PACs) (See section 3-1 DICOM Compatibility)
• the storage capacity corresponds to the Tomosynthesis intended use (See section 3-2 Storage
Capacity)
• the networking on site corresponds to the Tomosynthesis intended use (See section 3-3 Networking
Connections)
Contact a General Electric representative for further information and guidance on DICOM object
generation and its storage.
3-1 DICOM Compatibility

All workflow actors (such as PACS, archiver…) that will receive the Tomosynthesis images must
support: DICOM Storage as SCP for: Breast Tomosynthesis Image 1.2.840.10008.5.1.4.1.1.13.1.3
(SOP class UID) with at least one of the following proposed transfer syntax:
• Explicit VR Big Endian - 1.2.840.10008.1.2.2
• Implicit VR Little Endian - 1.2.840.10008.1.2
• Explicit VR Little Endian - 1.2.840.10008.1.2.1
• Lossless JPEG Compression - 1.2.840.10008.1.2.4.70
• Lossy JPEG Compression - 1.2.840.10008.1.2.4.51 (when authorized on site)
3-2 Storage Capacity

A General Electric representative can support the customer to evaluate the storage capacity needed for
the intended use of Tomosynthesis. The customer might plan to upgrade the storage capacity available
to meet the storage need.
Synchronize the Senographe Pristina 3D option installation to the data storage capacity upgrade when
applicable.
3-3 Networking Connections

In order to benefit from the optimal performance of the Senographe Pristina 3D option, the client should
provide a Gigabit Ethernet compatible connection to the network.
Other networking requirements remain the same as those described in the Senographe Pristina Service
Manual.
4 Associated Review Workstations

The Senographe Pristina 3D option requires a review workstation compatible with DICOM Digital Breast
Tomosynthesis images to display the reconstructed 3D objects.
The GE SenoIris release is compatible with this DICOM format.
Note:
Before installing the Senographe Pristina 3D option, ensure that customer’s workstation GE
SenoIris is installed. The review workstation at version 4.7.0 and lower is not compatible with the
Chapter 4 Page no. 36 Pre Installation.fm

Senographe Pristina 3D option. If the customer’s review workstation system needs upgrading to
GE SenoIris, it can take several weeks to receive the upgrade software. In scenarios where the
customer’s review workstation needs upgrading to GE SenoIris, ensure that you plan enough time
to install the Senographe Pristina 3D option after the upgrade of the review workstation system.
GE SenoIris is compatible with DICOM Digital Breast Tomosynthesis images coming from the previous
GE Breast Tomosynthesis system SenoClaire.
5 PACS Compatibility
Before the Senographe Pristina 3D installation, make sure that the PACS (and/or other storage devices
on site) are able to store DICOM Breast Tomosynthesis Objects (BTO).
All workflow actors (such as PACS, archiver…) that will receive the Tomosynthesis images must support
DICOM Storage as SCP for: Breast Tomosynthesis Image 1.2.840.10008.5.1.4.1.1.13.1.3 (SOP class
UID) with at least one of the following proposed transfer syntaxes:
• Explicit VR Big Endian - 1.2.840.10008.1.2.2
• Implicit VR Little Endian - 1.2.840.10008.1.2
• Explicit VR Little Endian - 1.2.840.10008.1.2.1
• Lossless JPEG Compression - 1.2.840.10008.1.2.4.70
• Lossy JPEG Compression - 1.2.840.10008.1.2.4.51 (when authorized on site)
The PACS (and/or other storage devices on site) BTO compatibility can be tested from the GE SenoIris
workstation, by loading BTO test objects to the workstation and then pushing them from it to the PACS
(and/or other storage devices on site).
Pre Installation.fm Page no. 37 Chapter 4


Chapter 4 Page no. 38 Pre Installation.fm

Last_Page.fm Page no. 39

To contact your local service representative, please go to:
http://www.gehealthcare.com/helpcenter.html
China service agent address:

通用电气医疗系统贸易发展（上海）有限公司
中国 ( 上海 ) 自由贸易试验区意威路 96 号 1 幢，邮编 200131
Turkey importer name:

GE Medical Systems Türkiye Ltd. Şti.
Esentepe Mah. Harman Sok. No:8
34394 Sisli-Istanbul Turkey
Manufacturer and Manufacturing site:

GE MEDICAL SYSTEMS SCS
283 RUE DE LA MINIERE
78530 BUC France

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ПРЕДУПРЕЖДЕНИЕ Това упътване за работа е налично само на английски и френски

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ADVARSEL Denne servicehåndboken finnes bare på engelsk og fransk.

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Chapter 1. Publication Presentation

Chapter 3. System Description

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Chapter 4. Pre Installation System Requirements

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Chapter 1 Publication Presentation

1 Scope and Applicability of the Publication

2 Content of this Publication

2-2 Publication Presentation

2-3 Descriptive Chapters

2-4 Procedural Chapters

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2-4-3 Job Card and Scenario Categories

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3-2 Entering and Typing Instructions

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4 Accessing Technical Publications

The Technical Publications Release Letter for this system is 5776078-899.

2. Search for and download the Technical Publication.

Reference Date Designation