HHS

Beam Quality Test

46-017562
Revision 31
US English
General service documentation.
© 2023 GE HealthCare. GE is a trademark of General Electric Company used under trademark license.
Reproduction and/or distribution is prohibited.
Beam Quality Test

Important...X-Ray Protection
WARNING

X-ray equipment if not properly used may cause injury. Accordingly, the instructions
herein contained should be 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 protection against x-radiation
other than the useful beam, no practical design of equipment can provide complete
protection. Nor can any practical design compel 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 acquainted with 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, and 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.

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 Beam Quality Test

Language Policy
DOC0371395 - Global Language Procedure

ПРЕДУПРЕЖ Това упътване за работа е налично само на английски език.

ДЕНИЕ • Ако доставчикът на услугата на клиента изиска друг език, задължение на клиента е да
(BG) 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。
UPOZOR- Ovaj servisni priručnik dostupan je na engleskom jeziku.
ENJE • Ako davatelj usluge klijenta treba neki drugi jezik, klijent je dužan osigurati prijevod.
(HR) • 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 mechan-
ických či jiných rizik.
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.

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Beam Quality Test

WAAR- Deze onderhoudshandleiding is enkel in het Engels verkrijgbaar.

SCHUWING • Als het onderhoudspersoneel een andere taal vereist, dan is de klant verantwoordelijk voor
(NL) 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 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.
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 vigas-
tamist 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 käyt-
täjän 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 mainte-
nance 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 verstan-
den 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.
ΠΡΟΕΙΔΟΠΟΙ Τοπαρόν εγχειρίδιο σέρβις διατίθεται στα αγγλικά μόνο.
ΗΣΗ • Εάν το άτομο παροχής σέρβις ενός πελάτη απαιτεί το παρόν εγχειρίδιο σε γλώσσα εκτός των
(EL) αγγλικών, αποτελεί ευθύνη του πελάτη να παρέχει υπηρεσίες μετάφρασης.
• Μηνεπιχειρήσετε την εκτέλεση εργασιών σέρβις στον εξοπλισμό εκτός εάν έχετε
συμβουλευτεί και έχετε κατανοήσει το παρόν εγχειρίδιο σέρβις.
• Εάν δεν λάβετε υπόψη την προειδοποίηση αυτή, ενδέχεται να προκληθεί τραυματισμός στο
άτομο παροχής σέρβις, στο χειριστή ή στον ασθενή από ηλεκτροπληξία, μηχανικούς ή άλλους
κινδύνους.

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 Beam Quality Test

FIGYELMEZ- Ezen karbantartási kézikönyv kizárólag angol nyelven érhető el.

TETÉS • Ha a vevő szolgáltatója angoltól eltérő nyelvre tart igényt, akkor a vevő felelőssége a fordítás
(HU) 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 sjú-
klings 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 man-
utenzione, 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 영어로만 이용하실 수 있습니다.
(KO) • 고객의 서비스 제공자가 영어 이외의 언어를 요구할 경우, 번역 서비스를 제공하는 것은
고객의 책임입니다.
• 본 서비스 매뉴얼을 참조하여 숙지하지 않은 이상 해당 장비를 수리하려고 시도하지 마십
시오.
• 본 경고 사항에 유의하지 않으면 전기 쇼크, 기계적 위험, 또는 기타 위험으로 인해 서비스
제공자, 사용자 또는 환자에게 부상을 입힐 수 있습니다.
BRĪDINĀ- Šī apkopes rokasgrāmata ir pieejama tikai angļu valodā.
JUMS • Ja klienta apkopes sniedzējam nepieciešama informācija citā valodā, klienta pienākums ir
(LV) 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 kalba.
(LT) • Jei kliento paslaugų tiekėjas reikalauja vadovo kita kalba – ne anglų, suteikti vertimo paslau-
gas privalo klientas.
• Nemėginkite atlikti įrangos techninės priežiūros, jei neperskaitėte ar nesupratote šio eksploa-
tavimo vadovo.
• Jei nepaisysite šio įspėjimo, galimi paslaugų tiekėjo, operatoriaus ar paciento sužalojimai dėl
elektros šoko, mechaninių ar kitų pavojų.

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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.
OSTRZEŻE- Niniejszy podręcznik serwisowy dostępny jest jedynie w języku angielskim.
NIE • Jeśli serwisant klienta wymaga języka innego niż angielski, zapewnienie usługi tłumaczenia
(PL) jest obowiązkiem klienta.
• Nie próbować serwisować urządzenia bez zapoznania się z niniejszym podręcznikiem serwi-
sowym 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.
(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 assis-
tência 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 assis-
tência 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 pa-
cientului în urma pericolelor de electrocutare, mecanice sau de altă natură.
ОСТОРОЖНО Данное руководство по техническому обслуживанию представлено только на английском
! языке.
(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.
UPOZOR- Ovo servisno uputstvo je dostupno samo na engleskom jeziku.
ENJE • Ako klijentov serviser zahteva neki drugi jezik, klijent je dužan da obezbedi prevodilačke
(SR) usluge.
• Ne pokušavajte da opravite uređaj ako niste pročitali i razumeli ovo servisno uputstvo.
• Zanemarivanje ovog upozorenja može dovesti do povređivanja servisera, rukovaoca ili paci-
jenta usled strujnog udara ili mehaničkih i drugih opasnosti.

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 Beam Quality Test

UPOZORNE- Tento návod na obsluhu je k dispozícii len v angličtine.

NIE • Ak zákazníkov poskytovateľ služieb vyžaduje iný jazyk ako angličtinu, poskytnutie preklada-
(SK) teľských 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.
ATENCIÓN 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 service-
handboken.
• 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.
ЗАСТЕРЕЖЕ Даний посібник з експлуатації доступний тільки англійською мовою.
ННЯ • Якщо постачальник послуг клієнта спілкується іноземною мовою, тоді клієнт
(UK) зобов'язаний забезпечити переклад.
• Заборонено проводити огляд обладнання без попереднього звертання до даного
посібника з експлуатації і розуміння інформації, поданої у ньому.
• Недотримання цього застереження може завдати шкоди здоров’ю постачальника
послуг, оператора або пацієнта через ураження електричним струмом, механічну
травму або інше ушкодження.

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Revision History
Rev Date Reason for change
0 Sept. 24, 1993 Initial release.
1 May 24, 1995 Note added to recording data.
2 Apr. 30, 1996 Minor updates.
3 Dec. 1, 1997 Revised to include hardcopy form references for third party users.
4 Nov. 24, 2000 Added notes, following INNOVA 2000 introduction.
5 Nov. 14, 2001 Added notes, for INNOVA 2000 for M4B.
6 March 14, 2003 Updated for INNOVA 4100 for ME2. SPR BUge86469.
7 July 15, 2003 Updated for INNOVA 4100 for M3a.
8 Oct 6, 2004 Updated for INNOVA 3100/4100. References to Innova 3100 added
to pages 3 & 4 (SPR EURge15070).
9 Jan 19, 2005 Updated for SPR EURge16987 (added mGy units along with Roent-
gen units) in page 8.
10 April 12, 2005 Updated for Innova 2100–IQ information.
11 February 15, 2006 Added new values for Beam Quality test (SPR EURge39873) and
Innova 3100–IQ and Innova 4100–IQ information.
12 June 5, 2006 CFR 1020.30/31/32 regulatory compliance.
13 June 20, 2006 Updated for SPR EURge51785.
14 July 20, 2007 Added: Innova 2121–IQ and Innova 3131–IQ information.
15 Dec. 20, 2007 Converted from Interleaf into e-CLS platform.
16 May 5, 2010 Updated to modify Finalization section of REG0065
17 August 5, 2010 New update of REG0065
18 July 21, 2011 Update of REG0065 to introduce Innova IGS 520, 530, 540
19 September 26, 2011 Update of REG0065 to introduce Discovrey IGS 730
20 January 20, 2012 Update of REG0065 to introduce Innova IGS 620, 630
21 January 30, 2012 Update of REG0065 for Discovrey IGS 730
22 May 29, 2012 Update of REG0065 for Optima CL320i/CL323i
23 August 20, 2013 Update of REG0065 to introduce Discovery IGS 740 and change
product name to DiscoveryTM IGS 730, DiscoveryTM IGS 740
24 September 4, 2013 Update of REG0065 to introduce Optima IGS320
25 September 4, 2014 Update of REG0065 to change product name to “InnovaTM IGS 620”
and “InnovaTM IGS 630”
26 March 4, 2015 Update of REG0065 to introduce “Optima IGS 330 and change prod-
uct name to “Optima IGS 320”.
27 July 5, 2017 Update of REG0065 to introduce “InnovaTM IGS 5”, “InnovaTM IGS 6”,
“DiscoveryTM IGS 7” and “DiscoveryTM IGS 7 OR”.
28 January 2021 Updated of REG0065 to introduce "Allia™ IGS 7", "Allia™ IGS 7 OR",
"Allia™ IGS Systems" and "Optima IGS Plus"
29 November 2021 Update of REG0065 to introduce "Allia™ IGS 3" and "Allia™ IGS 5".
30 June 2022 Update of REG0065 to introduce "Optima™ IGS Ultra" and "Opti-
ma™ IGS Mega"
31 June 2023 Update of REG0065 to introduce focal spot changes

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Beam Quality Test Contents

Contents
1 Beam Quality Test ........................................................................................................... 13
1.1 Safety .................................................................................................................................................... 13
1.2 REG0065 - Beam Quality Test............................................................................................................... 14
1.3 REG0066 - Beam Quality Test - Graphical Method .............................................................................. 21

46-017562 Revision 31 HHS 11/26

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 1
1 Beam Quality Test

1.1 Safety
X-Ray Protection

WARNING

X-RAY EQUIPMENT IF NOT PROPERLY USED MAY CAUSE INJURY. ACCORDINGLY,

THE INSTRUCTIONS HEREIN CONTAINED SHOULD BE THOROUGHLY READ AND
UNDERSTOOD BY EVERYONE WHO WILL USE THE EQUIPMENT BEFORE YOU ATTEMPT
TO PLACE THIS EQUIPMENT IN OPERATION. THE GENERAL ELECTRIC COMPANY,
MEDICAL SYSTEMS GROUP, WILL BE GLAD TO ASSIST AND COOPERATE IN PLACING
THIS EQUIPMENT IN USE.
ALTHOUGH THIS APPARATUS INCORPORATES A HIGH DEGREE OF PROTECTION
AGAINST X-RADIATION OTHER THAN THE USEFUL BEAM, NO PRACTICAL DESIGN
OF EQUIPMENT CAN PROVIDE COMPLETE PROTECTION. NOR CAN ANY PRACTICAL
DESIGN COMPEL THE OPERATOR TO TAKE ADEQUATE PRECAUTIONS TO PREVENT
THE POSSIBILITY OF ANY PERSONS CARELESSLY EXPOSING THEMSELVES OR OTHERS
TO RADIATION. IT IS IMPORTANT THAT EVERYONE HAVING ANYTHING TO DO
WITH X-RADIATION BE PROPERLY TRAINED AND FULLY ACQUAINTED WITH 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,
AND TAKE ADEQUATE STEPS TO PROTECT AGAINST INJURY. THE EQUIPMENT IS
SOLD WITH THE UNDERSTANDING THAT THE GENERAL ELECTRIC COMPANY, MEDICAL
SYSTEMS GROUP, ITS AGENTS, AND REPRESENTATIVES HAVE NO RESPONSIBILITY
FOR INJURY OR DAMAGE WHICH MAY RESULT FROM IMPROPER USE OF THE
EQUIPMENT. VARIOUS PROTECTIVE MATERIAL AND DEVICES ARE AVAILABLE. IT IS
URGED THAT SUCH MATERIALS OR DEVICES BE USED.

CAUTION

United States Federal law restricts this device to use by or on the order of a physician.

Certified Electrical Contractor Statement

All electrical installations that are preliminary to positioning of the equipment at the site prepared
for the equipment shall be performed by licensed electrical contractors. In addition, electrical
feeds into the Power Distribution Unit shall be performed by licensed electrical contractors.
Other connections between pieces of electrical equipment, calibrations, and testing shall be
performed by qualified GE Medical personnel. The products involved (and the accompanying
electrical installations) are highly sophisticated, and special engineering competence is required.
In performing all electrical work on these products, GE will use its own specially trained field
engineers. All of GE’s electrical work on these products will comply with the requirements of the
applicable electrical codes.
The purchaser of GE equipment shall only utilize qualified personnel (i.e., GE’s field engineers,
personnel of third-party service companies with equivalent training, or licensed electricians) to
perform electrical servicing on the equipment.

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1.2 REG0065 - Beam Quality Test Beam Quality Test

Damage in Transportation
All packages should be closely examined at time of delivery. If damage is apparent, have
notation “damage in shipment” written on all copies of the freight or express bill before delivery is
accepted or “signed for” by a General Electric representative or a hospital receiving agent. Whether
noted or concealed, damage MUST be reported to the carrier immediately upon discovery, or in
any event, within 14 days after receipt, and the contents and containers held for inspection by the
carrier. A transportation company will not pay a claim for damage if an inspection is not requested
within this 14 day period.
Call Traffic and Transportation, Milwaukee, Phone: 800-548-3366. Option 6 immediately after
damage is found. At this time be ready to supply name of carrier, delivery date, consignee name,
freight or express bill number, item damaged and extent of damage.
Complete instructions regarding claim procedure are found in Section “S” of the Policy &
Procedure Bulletins (6/17/94).

1.2 REG0065 - Beam Quality Test

Table 1-1 Personnel requirements

Required persons Preliminary require- Procedure Finalization

ments
1 Not Applicable 30 minutes Not Applicable

All diagnostic source assemblies at installation and whenever replacing tube unit insert, mylar
window, collimator mirror, table top, or other absorption between source and patient.
NOTE
Refer to 46-017565 HHS MAMMOGRAPHY TESTS for Mammographic units.
Discovery™ IGS 730, Discovery™ IGS 740 systems or Discovery™ IGS 7 and Discovery™ IGS 7 OR
systems are also named Discovery™ IGS Systems. The procedure is applicable indifferently to
Discovery™ IGS 730 or Discovery™ IGS 740 or Discovery™ IGS 7 or Discovery™ IGS 7 OR.
Allia™ IGS 5 and Allia™ IGS 7 and Allia™ IGS 7 OR are also named Allia™ IGS Systems. The procedure
is applicable indifferently to Allia™ IGS 5 or Allia™ IGS 7 or Allia™ IGS 7 OR.

Requirement
1. The half–value layer of useful beam at a given kVp shall not be less than that shown in
the following table. These requirements are from 21CFR part 1020.30 (m). Specific test point
is at 80 kVp, thus the minimum half–value layer requirement is 2.3 mm of aluminum for
systems manufactured before June 10th, 2006. The minimum half–value layer for systems
manufactured On or After June 10th, 2006 is 2.9 mm aluminum @ 80 kVp
Table 1-2 Minimum Half-Value Layer

Design Operat- Selected Minimum Half-Value Layer (Milli- Minimum Half-Value Layer (Milli-
ing Range (Kilo- kVp meters of Aluminum)** For Sys- meters of Aluminum)** For Sys-
volts Peak) tems manufactured before June tems manufactured on or after
10th, 2006 June 10th, 2006
Below 51 30 0.3 0.3
40 0.4 0.4
50 0.5 0.5
51 to 70 51 1.2 1.3

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Beam Quality Test 1.2 REG0065 - Beam Quality Test

Table 1-2 Minimum Half-Value Layer (Table continued)

Design Operat- Selected Minimum Half-Value Layer (Milli- Minimum Half-Value Layer (Milli-
ing Range (Kilo- kVp meters of Aluminum)** For Sys- meters of Aluminum)** For Sys-
volts Peak) tems manufactured before June tems manufactured on or after
10th, 2006 June 10th, 2006 1
60 1.3 1.5

Beam Quality Test

70 1.5 1.8
Above 70 71 2.1 2.5
80* 2.3 2.9*
90 2.5 3.2
100 2.7 3.6
110 3.0 3.9
120 3.2 4.3
130 3.5 4.7
140 3.8 5.0
150 4.1 5.4

NOTE
* Specific test point.
**Type 1100 aluminum, or better.
2. Since the standard test absorber is 2.5 mm, the procedure described below allows for
radiation measurement tolerance with respect to rejection limits for systems manufactured
before June 10th, 2006. The set of Aluminum Filters (46–194427P274) in the HHS kit allows for
correct HVL test filtration thickness when added to the 2.5 mm standard test absorber.
For Systems manufactured On or After June 10th, 2006 the default HVL test filtration is 3.1 mm
of Aluminum unless specifically stated otherwise in the following table.
Table 1-3 System Specific Details

Standard Absorber Total Test Aluminum Filtration Be- Total Test Aluminum Filtration On
fore June 10th, 2006 in millime- or After June 10th, 2006 in millime-
ters ters
AMX 46–173632G2 2.5 3.0
Precision 500D 46–173632G1 2.5 3.0
Definium 8000 46–173632G1 2.5 3.0
Proteus 46–173632G1 2.5 3.0
Silhouette VR 46–173632G1 2.5 3.0
Other 46–173632G1 2.5 3.1

NOTE
The following applies:
• HVL is very dependent on the actual kVp value. The kV accuracy test must have
been performed prior to HVL measurement.
• Record the data (apply any corrective factor if required and check final results
are within acceptance criteria) and complete THE FDA 2579 FORM.

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1.2 REG0065 - Beam Quality Test Beam Quality Test

Procedure
Summary:
• Measure radiation level at prescribed exposure technic.
• Add the standard absorber and measure reduced radiation level. This measurement must
indicate 50% or more of initial reading.
• If less than 50%, remove standard absorber and add fixed absorption to the beam.
• It will be found, generally, that radiographic X-ray sources with collimators already include
sufficient filtration (due to mirror in collimator), but that under table and other X-ray sources
without light beams may require additional fixed filtration.
1. NOTE
The following applies:
• On undertable tube systems, check factory documentation. In some cases,
(H.L.A.), the correct filtration has been added at the factory, and only
verification that filter is in place is required.
• For alternate method, refer also to REG0066 - Beam Quality Test - Graphical
Method on page 21.
Position radiation probe as shown in the following illustration.
NOTE
Circular Field Collimators 46–246840G5 are shipped with 1 mm aluminum
equivalent filtration at 150 KVP installed, and an additional 0.5 mm to be installed
if needed. If the added filtration is NOT installed, affix the label from Label
2135807 which indicates that the collimator has 1 mm aluminum equivalence to the
collimator. If the extra 0.5 mm filter is installed, affix the label from Label 2135807
which indicates that the collimator has 1.5 mm aluminum equivalence to the
collimator. Both labels are attached to the same peel-off carrier for convenience.
Discard the unused label. Reference: Labeling Instructions 2136680IDW.
Figure 1-1 Half Value Layer - Good Geometry

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Beam Quality Test 1.2 REG0065 - Beam Quality Test

NOTE
Common problems to avoid:
• Useful beam smaller than active area of probe.
• Useful beam significantly larger than active area of probe. 1
• Probe not 12” from absorber.

Beam Quality Test

• Intensifier (or anything else) within 4” of probe.
NOTE
If table top is normally in the beam, then the half value layer shall be tested in that
configuration.
For fluoroscopic tests, use an exposure rate or exposure measuring instrument, and for
radiographic tests use an exposure measuring instrument. Refer to the following illustration
for a typical LU or LC gantry configuration.
Figure 1-2 Half Value Layer - Test Set-up

NOTE
On systems that can be positioned so that the table top is not in the X-Ray beam,
the half value layer must be tested in that configuration (i.e., table top not in beam).
2. The optimum position for the standard absorber is midway between the focal spot and the
radiation probe. Other positions will introduce reading errors. For example, if the absorber
is placed close to the probe, then the probe will receive excess scatter and the absorber will
appear to have absorbed less.
3. Position image intensifiers or other equipment at least 4 away from probe to prevent radiation
scatter errors.
4. Set technic factors as follows:
• Fluoroscopic: 80 kVp, 2 mA (use Spot-Film mode if possible).
• Radiographic: 80 kVp, 50 to 100 mA, 1/2 to 1 second. mA and time should be adjusted so
that reading in Step 6 contains three significant digits.

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1.2 REG0065 - Beam Quality Test Beam Quality Test

5. NOTE
For all Innova, Optima, Discovery™ IGS Systems and Allia™ IGS Systems and Allia™
IGS 3, use X220 Fluoro Calibration Unit at 30 fps, in order to set the System in
manual mode without spectral filtration and for appropriate technic factors. The
test will be performed in Fluoro mode.
Remove or dial out all filters that are removable by the operator and collimate slightly larger
than active volume of probe using image system or light field.
NOTE
The following applies:
• For Innova 2000 Systems, select the fixed point HHS1, center the probe while
making exposures and collimate to probe volume. Then go to the Next Page
and select row: 80 kVp, 0.0667 mAs, 10 ms, FS=0.6, Spectral filter=0. Leave field
for LONG/LAT empty to keep previous collimator settings.
• For Innova 2100-IQ/2121-IQ, Innova 3100/3100-IQ/3131-IQ, Innova 4100/4100-
IQ systems, Innova IGS 520, 530, 540, Innova™ IGS 5, Allia™ IGS 3, Allia™ IGS
5, Innova™ IGS 620, Innova™ IGS 630, Innova™ IGS 6, Discovery™ IGS 730,
Discovery™ IGS 740, Discovery™ IGS 7, Discovery™ IGS 7 OR, Allia™ IGS 7, Allia™
IGS 7 OR, Optima™ CL320i/CL323i, Optima™ IGS Plus, Optima™ IGS 320, Optima™
IGS 330, Optima™ IGS Ultra and Optima™ IGS Mega, set the techniques below
(and click Submit button), center the probe while making exposures and
collimate to probe volume by reducing the Collimator LONG/LAT values (click
Submit button to validate changes).
Table 1-4 All systems except Allia IGS 7 and Allia IGS 7 OR systems from CFG8 and Allia IGS 5
systems from SP5

Exp.Mod Frame Focal kVp mA Pulse Spectral DLB Pres- LONG LAT
e Rate Spot peak Width Filter ence
Fluoro 30 0.6 60 1 2 None No 4000/3000

Table 1-5 Allia IGS 7 and Allia IGS 7 OR systems from CFG8 and Allia IGS 5 systems from SP5

Exp.Mod Frame Focal kVp mA Pulse Spectral DLB Pres- LONG LAT
e Rate Spot peak Width Filter ence
Fluoro 30 0.5 60 1 2 None No 4000/3000

Then, set the following technics (and click Submit button) for measurement phase:
Table 1-6 All systems except Allia IGS 7 and Allia IGS 7 OR systems from CFG8 and Allia IGS 5
systems from SP5

Exp.Mod Frame Focal kVp mA Pulse Spectral DLB Pres- LONG LAT
e Rate Spot peak Width Filter ence
Fluoro 30 0.6 80 6.67 10 None Yes See Note below

Table 1-7 Allia IGS 7 and Allia IGS 7 OR systems from CFG8 and Allia IGS 5 systems from SP5

Exp.Mod Frame Focal kVp mA Pulse Spectral DLB Pres- LONG LAT
e Rate Spot peak Width Filter ence
Fluoro 30 0.5 80 6.67 10 None Yes See Note below

NOTE
Let current values to keep collimator settings.

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Beam Quality Test 1.2 REG0065 - Beam Quality Test

6. Make an exposure and measure exposure or exposure rate with no added filters. Record
readings. This represents 100% transmission level.
7. Place the standard absorber 46–173632G1 in beam with additional required filtration for
systems manufactured On or After June 10th, 2006. Absorber must be on tabletop or in
collimator accessory rails. Repeat exposure and record reading. 1
8. Compute the ratio (Dose with absorber over dose without absorber). Check the Table

Beam Quality Test

1-8 on page 19 for action.
Table 1-8

System Manufacture Date If Ratio Is: Fixed Filtration Must Be:

Before June 10th, 2006 0.5 or greater* Left as is. No Change.
2.5 mm Aluminum minimum Less than 0.5 Added (mandatory)**
On or After June 10th, 2006 0.5 or greater* Left as is. No Change.
2.9 mm Aluminum minimum Less than 0.5 Added (mandatory)**

NOTE
*The 0.5 minimum ratio is mandatory. However, above 0.57, there will be a
noticeable reduction in radiation and loss of radiographic contrast.
For all Innova, Optima, Discovery™ IGS Systems and Allia™ IGS Systems and Allia™
IGS 3 the 0.57 ratio value may be exceeded on purpose and reach up to 0.7.
NOTE
**For Rad and R & F systems utilizing the Siemens Collimator, filtration cannot be
added. The collimator design does not support this:
• Verify kVp Accuracy.
• Verify test setup is correct. This is the most common error.
• Verify test equipment is functioning properly and within calibration.
• Issues reside at the system level interactions. Detailed analysis must be
performed to identify root cause of failure.
Collimators with mirrors usually require no additional filtration but, on the other hand,
excess filtration may not be removed. Filtration may only be removed if separate sheets
were previously added. The required change in filtration may be estimated as 0.5 mm for
each desired 0.05 change in ratio. For example, if the ratio is 0.48 the addition of 0.5 mm
of aluminum will raise the ratio by approximately 0.05 to a new ratio of approximately 0.53.
Re–test the system after adding filtration.
Fixed filters must be Type 1100 aluminum and should be mounted between the tube unit and
collimator whenever possible. If not possible (example: lead fingers of collimator interfere),
mount elsewhere between source and patient, but use piece large enough to intercept entire
beam, and mount permanently. A good mounting area in the Sentry Collimator is the back
of the mirror. Use a good quality adhesive such as contact cement or epoxy. Since the filter
will be at a 45 angle to the beam, use only about 0.7 of the thickness of aluminum that is
calculated. Recheck HVL before mounting permanently (use tape for temporary mounting).
Table 1-9 Mini-Troubleshooting Guide

Problem Possible Cause

HVL too high [>0.57] or [>0.7 (for kVp incorrect (high)
Innova, Optima, Discovery™ IGS Meter error – probe saturation, see REG0066 - Beam Quality Test -
Systems and Allia™ IGS Systems Graphical Method on page 21.
and Allia™ IGS 3)]

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1.2 REG0065 - Beam Quality Test Beam Quality Test

Table 1-9 Mini-Troubleshooting Guide

Problem Possible Cause

Excessive anode wear.
Excessive filter in beam.
For incorrect conditions of INNOVA 2000, check that spectral filtration
has not been used in the X220 input.
For incorrect conditions of Innova 2100-IQ/2121-IQ, Innova 3100/3100-
IQ/3131-IQ, Innova 4100/4100-IQ, Innova IGS 520, 530, 540, Innova™ IGS
5, Innova™ IGS 620, Innova™ IGS 630, Innova™ IGS 6, Discovery™ IGS
systems, Allia™ IGS Systems and Allia™ IGS 3, Optima™ CL320i/CL323i,
Optima™ IGS Plus, Optima™ IGS 320, Optima™ IGS 330, Optima™ IGS
Ultra and Optima™ IGS Mega, check that the spectral filter has been set
to 'None’.
HVL too low kVp incorrect (low).
Not enough filtration.

Acceptance Criteria for Vascular Systems (not applicable to Innova,

Optima, Discovery IGS Systems and Allia IGS Systems and Allia™ IGS
3)
1. If you have used a kVp meter RMI 230 or equivalent kVp–meter which allows 1 kVp accuracy,
the DOSE RATIO measured for 80 kV must stand between the Min Ratio and the Max Ratio value
according to the measured kVp value (refer to the following table).
Table 1-10

Measured 75 76 77 78 79 80 81 82 83 84 85
kVp
Min Ratio .519 .523 .526 .529 .533 .536 .540 .543 .546 .550 .553
Max Ratio .545 .549 .552 .555 .559 .562 .566 .569 .572 .576 .579

2. If a 1 kVp accuracy kVp meter was not used, the acceptance criteria is:
• CDRH REQT @ 80 KV: DOSE RATIO > 0.52
• IMAGING REQT: DOSE RATIO < 0.57

Recording Data
Record the data (apply any corrective factor if required and check final results are within
acceptance criteria):
1. The ratio of two readings using the standard absorber (after all fixed absorbers have been
installed).
2. The amount of fixed absorber added or removed from each source.

Finalization
No finalization steps.

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Beam Quality Test 1.3 REG0066 - Beam Quality Test - Graphical Method

1.3 REG0066 - Beam Quality Test - Graphical Method

Table 1-11 Personnel requirements
1
Required persons Preliminary require- Procedure Finalization

Beam Quality Test

ments
1 Not Applicable Not Applicable Not Applicable

Many Field Engineers have inquired about the graphical method of determining half value layer
used by the FDA, and so we are presenting that method here. The graphical method will provide
the actual value of the half value layer as opposed to the pass/fail result of the test shown earlier in
this section. Either method is acceptable for our purposes.
NOTE
For Mammography see 46–017565 HHS MAMMOGRAPHY TESTS.
The exposure rate at any given point is approximately a logarithmic function of the thickness of
filtration in the X–Ray beam. Therefore, if exposure readings are taken with various thicknesses
of added filtration in the beam, including zero added filtration, and the results are plotted on
semi–log paper as a function of the added filtration, then the result will be a straight line. The
point where this line crosses the 50% relative exposure level corresponds to the half value layer. In
practice the exposure readings are normalized, (each reading is divided by the exposure with zero
added filtration), before being plotted. In this way we plot relative exposure vs filter thickness.

Procedure
1. Follow the standard set up procedure as described earlier in this section, and take exposure
readings with zero, 1 mm, 2 mm, 3 mm, and 4 mm of added filtration. Take several exposures
at each filter thickness and obtain an average exposure for each filter.
2. Divide each reading by the exposure value obtained with zero added filtration. Express the
results as percentages. The reading with zero added filtration then becomes 100%.
3. Plot the data on semi–log paper, with the filter thickness being the standard axis and the
relative exposure values being the logarithmic axis. (Refer to the following illustration for

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1.3 REG0066 - Beam Quality Test - Graphical Method Beam Quality Test

example of a graph for half value layer.) You should be able to draw a straight line through the
points.
Figure 1-3

NOTE
If you can’t draw a straight line that goes through the 100% point and comes
within 2% or 3% of each of the other data points, then something changed during
the course of the test. Check for stable kVp, mA, meter or probe saturation, good
reproducibility, or a change in position of the probe.

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Beam Quality Test 1.3 REG0066 - Beam Quality Test - Graphical Method

4. Mark the point where the line of Step 3 crosses the 50% relative exposure line. Read the filter
thickness corresponding to this line. This is your half value layer.
NOTE
You must have at least one data point on each side of the 50% relative exposure. 1
Finalization

Beam Quality Test

No finalization steps.

46-017562 Revision 31 HHS 23/26

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