System Field Test For HHS: 46-013894 Revision 66 US English © 2021 General Electric Company All Rights Reserved

HHS
System Field Test for HHS
46-013894
Revision 66
US English
© 2021 General Electric Company
All rights reserved.
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.
Language Policy
Direction 2128126 - Language Policy For Service Documentation
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。
46-013894 Revision 66 HHS 3/18

UPOZORENJE Ovaj servisni priručnik dostupan je na engleskom jeziku.

(HR) • Ako davatelj usluge klijenta treba neki drugi jezik, klijent je dužan osigurati prijevod.
• Ne pokušavajte servisirati opremu ako niste u potpunosti pročitali i razumjeli ovaj servisni
priručnik.
• Zanemarite li ovo upozorenje, može doći do ozljede davatelja usluge, operatera ili pacijenta
uslijed strujnog udara, mehaničkih ili drugih rizika.
VÝSTRAHA Tento provozní návod existuje pouze v anglickém jazyce.
(CS) • V případě, že externí služba zákazníkům potřebuje návod v jiném jazyce, je zajištění překladu do
odpovídajícího jazyka úkolem zákazníka.
• Nesnažte se o údržbu tohoto zařízení, aniž byste si přečetli tento provozní návod a pochopili
jeho obsah.
• V případě nedodržování této výstrahy může dojít k poranění pracovníka prodejního servisu, ob-
služného personálu nebo pacientů vlivem elektrického proudu, respektive vlivem mechanických
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.
WAAR- Deze onderhoudshandleiding is enkel in het Engels verkrijgbaar.
SCHUWING • Als het onderhoudspersoneel een andere taal vereist, dan is de klant verantwoordelijk voor de
(NL) vertaling ervan.
• Probeer de apparatuur niet te onderhouden alvorens deze onderhoudshandleiding werd ger-
aadpleegd 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 vigasta-
mist 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 käyttä-
jän tai potilaan vahingoittuminen sähköiskun, mekaanisen vian tai muun vaaratilanteen vuoksi.
4/18 HHS 46-013894 Revision 66

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
(EL) των 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.
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 sjúklings
frá raflosti, vélrænu eða öðrum áhættum.
AVVERTENZA Il presente manuale di manutenzione è disponibile soltanto in lingua inglese.
(IT) • Se un addetto alla manutenzione richiede il manuale in una lingua diversa, il cliente è tenuto a
provvedere direttamente alla traduzione.
• Procedere alla manutenzione dell'apparecchiatura solo dopo aver consultato il presente man-
uale ed averne compreso il contenuto.
• Il mancato rispetto della presente avvertenza potrebbe causare lesioni all'addetto alla manu-
tenzione, 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。
46-013894 Revision 66 HHS 5/18

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 paslaugas
privalo klientas.
• Nemėginkite atlikti įrangos techninės priežiūros, jei neperskaitėte ar nesupratote šio eksploata-
vimo vadovo.
• Jei nepaisysite šio įspėjimo, galimi paslaugų tiekėjo, operatoriaus ar paciento sužalojimai dėl
elektros šoko, mechaninių ar kitų pavojų.
ADVARSEL Denne servicehåndboken finnes bare på engelsk.
(NO) • Hvis kundens serviceleverandør har bruk for et annet språk, er det kundens ansvar å sørge for
oversettelse.
• Ikke forsøk å reparere utstyret uten at denne servicehåndboken er lest og forstått.
• Manglende hensyn til denne advarselen kan føre til at serviceleverandøren, operatøren eller
pasienten skades på grunn av elektrisk støt, mekaniske eller andre farer.
OSTRZEŻENIE Niniejszy podręcznik serwisowy dostępny jest jedynie w języku angielskim.
(PL) • Jeśli serwisant klienta wymaga języka innego niż angielski, zapewnienie usługi tłumaczenia jest
obowiązkiem klienta.
• Nie próbować serwisować urządzenia bez zapoznania się z niniejszym podręcznikiem serwiso-
wym i zrozumienia go.
• Niezastosowanie się do tego ostrzeżenia może doprowadzić do obrażeń serwisanta, operatora
lub pacjenta w wyniku porażenia prądem elektrycznym, zagrożenia mechanicznego bądź inne-
go.
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.
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.
6/18 HHS 46-013894 Revision 66

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 pacien-
tului 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.
UPOZORENJE Ovo servisno uputstvo je dostupno samo na engleskom jeziku.
(SR) • Ako klijentov serviser zahteva neki drugi jezik, klijent je dužan da obezbedi prevodilačke usluge.
• Ne pokušavajte da opravite uređaj ako niste pročitali i razumeli ovo servisno uputstvo.
• Zanemarivanje ovog upozorenja može dovesti do povređivanja servisera, rukovaoca ili pacijenta
usled strujnog udara ili mehaničkih i drugih opasnosti.
UPOZORNE- Tento návod na obsluhu je k dispozícii len v angličtine.
NIE • Ak zákazníkov poskytovateľ služieb vyžaduje iný jazyk ako angličtinu, poskytnutie prekladateľ-
(SK) ských 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.
46-013894 Revision 66 HHS 7/18

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.
ЗАСТЕРЕЖЕН Даний посібник з експлуатації доступний тільки англійською мовою.
НЯ • Якщо постачальник послуг клієнта спілкується іноземною мовою, тоді клієнт зобов'язаний
(UK) 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.
Revision History
Rev Date Reason for change
G Sept. 1, 1983 First seven revisions (A-G) used a different revision control system;
revision dates and data were not preserved.
9 Nov. 20, 1985 Incorporates changes resulting from review of Rev. 8 by the district
compliance engineers.
10 Aug. 22, 1986 Revised Tests 5-1 and 5-2 geometry for C-Arm. Revised Test 5–3 for
uncertified tables. Revised Test 6-2-3 for 5 x 5 cm minimum size
requirement.
11 Nov. 12, 1987 Table 1–1 is amended to indicate correct use of calibration and
application modes for AMX-4.
12 June 20, 1989 Clarifies Sec. 3-1 and Sec. 3-5 for Advantx and non-Advantx systems.
13 Feb. 28, 1991 Added Section 7, Mammography. Added Section 10, Stenoscop. Add-
ed Forms F3382MX, F3382MM and F3382SS to Section 8. General
revisions. Preliminary not released for publication, archived microfi-
che only.
14 Mar. 29, 1991 General revisions and corrections.
15 July 26, 1991 Added new HHS Field Test Kit 46–303879G1.
16 Dec. 20, 1991 Updated Forms F3382, F3382MM, F3382SS, and F4285 in Section 8.
17 May 22, 1992 Updates Tables 1–1, 1–4 and 1–5 in Section 1 and Form F3382MX in
Section 8 to include Mobil–Aid AEC Tests 3–5 and 3–6, and to include
the VMX generator.
18 Sept. 24, 1993 Changed Direction 46–013894 to a collector. General revisions and
changes.
19 June 20, 1995 Revised direction 46–017562.
20 Apr. 30, 1996 General revisions and changes.
21 Dec. 1, 1997 Updated 46–017559, 46–017560, 46–017561, 46–017562, 46–
017563, 46–017564, 46–017565 and 46–017566.
22 Apr. 8, 1998 Updated 46–017563.
23 July 8, 1998 Updated 46–017563.
24 Oct. 8, 1999 Added HHS Field Signature tests, 2257181–100
25 Nov. 24, 2000 Updated 46–017561, 46–017562, 46–017563 and 46–017568, fol-
lowing INNOVA 2000 introduction.
8/18 HHS 46-013894 Revision 66


26 Nov. 15, 2001 Updated 46–017561, 46–017562 and 46–017563.
27 June 14, 2002 Updated 46–017563 and 46–017564 for Precision 500D system.
28 March 28, 2003 Updated 46–017561, 46–017562 and 46–017563 for Innova 4100.
29 July 15, 2003 Updated 46–017560, 46–017561, 46–017562, 46–017563, 46–
017564 for Innova 4100, M3a.
30 August 6, 2003 Updated 46–017561 for Innova 4100, M3a.
31 October 17, 2003 Updated 46–017561 and 46–017563 for Innova 4100, M3b.
32 April 23, 2004 Updated 46–017560, 46–017561, 46–017563 and 46–017564 for
Innova 3100/4100.
33 June 30, 2004 Updated 46–017560, 46–017561, 46–017563 for Innova 3100/4100.
34 October 6, 2004 Updated 46–017562 for Innova 3100/4100 (SPR EURge15070).
35 January 19, 2005 Updated 46–017562, 46–017563, 46–017566, and 46–017567, for
Innova Liberty Bolus milestone M3 (SPR EURge16987) 46–017561
(SPR EURge20430)
36 May 12, 2005 Updated 46–017561 (SPR EURge23969) 46–017562, 46–017563 and
46–017564 updated with Innova 2100–IQ information.
37 February 15, 2006 Updated:
• 46–017560, 46–017561, 46–017564 by adding Innova 3100-IQ
and Innova 4100-IQ information.
• 46–017562 by adding new values for Beam Quality test
(EURge39873) and Innova 3100-IQ and Innova 4100-IQ informa-
tion.
• 46–017563 by correcting unit of measure and adding Innova
3100-IQ and Innova 4100-IQ information.
• 46–017566 updated by adding Section 7: Form 3382 (SPR
EURge45188).
38 June 5, 2006 The following documents were updated for CFR 1020.30/31/32 regu-
latory compliance: 46–017561, 46–017562 and 46–017566.
39 June 20, 2006 Updated 46–017562 (SPR EURge51785).
40 July 12, 2006 Update 46–017563 (SPR53442): tube leakage radiation suppression
on INNOVA.
41 July 20, 2007 Innova 2121–IQ and 3131–IQ added in 46–017560, 46–017561, 46–
017562, 46–017563, 46–017564 and 46–017566.
42 October 9, 2007 Updated 46–017563 (SPR EURge80436 and EURge76947)
43 December 20, 2007 • Conversion from Interleaf into e-CLS Platform.
• Updated 46–017563 (SPR EURge81110)
44 January 25, 2008 Updated 46–017564 and 46-017566 (SPR EURge86024).
45 May 9, 2008 46-017560 and 46-017563 updated with new Victoreen tool.
46-017564 updated to add Chapter 2 content.
46 November 12, 2008 46-017564 updated for collimator alignment procedure
(EURge95590)
47 February 12, 2010 46-017564 updated for collimator gain value limitation procedure
(INTge09620)
48 May 4, 2010 46-017561, 46-017562, 46-017563, 46-017564 updated to modify
Finalization sections of REG0052, REG0056, REG0057, REG0058,
REG0065, REG0067, REG0069 and REG0086
46-013894 Revision 66 HHS 9/18


49 August 5, 2010 46-017560 updated for Radiation Instruments in chapter 5
46-017561, 46-017562, 46-017563, 46-017564 updated to modi-
fy again Finalization sections of REG0052, REG0056, REG0057,
REG0058, REG0065, REG0067, REG0069 and REG0086
50 January 26, 2011 46-017561, 46-017563 updated to modify title of REG0058 and
REG0069
51 March 18, 2011 46-017563 updated for alternate dosimeters (REG0069)
52 July 21, 2011 46-017560 updated to introduce Innova IGS 520, 530, 540
46-017561 updated to introduce Innova IGS 520, 530, 540
53 September 26, 2011 46-017560, 46-017561, 46-017562, 46-017563 and 46-017564 up-
dated to introduce Discovrey IGS 730
54 January 20, 2012 46-017560, 46-017561, 46-017562, 46-017563 and 46-017564 up-
dated to introduce Innova IGS 620, 630
55 February 8, 2012 46-017561, 46-017562, 46-017563 updated to modify Finalization
of REG0052, REG0056, REG0057, REG0058, REG0065, REG0067 and
REG0069 for Discovrey IGS 730
56 May 29, 2012 46-017560, 46-017561, 46-017562, 46-017563 and 46-017564 up-
dated to introduce Optima CL320i/CL323i
57 March 10, 2013 46-017564 updated to modify REG0086
58 August 20, 2013 46-017560, 46-017562 and 46-017563 updated to introduce Discov-
ery IGS 740 and change product name to DiscoveryTM IGS 730, Dis-
coveryTM IGS 740
46-017561 updated to modify Jedi tool cover p/n in REG0056 and
REG0057, introduce Discovery IGS 740 and change product name to
DiscoveryTM IGS 730, DiscoveryTM IGS 740
46-017564 updated to modify REG0086 for P011, introduce Discov-
ery IGS 740 and change product name to DiscoveryTM IGS 730, Dis-
coveryTM IGS 740
59 September 4, 2013 46-017560, 46-017561, 46-017562, 46-017563 and 46-017564 up-
dated to introduce Optima IGS320.
60 September 4, 2014 46-017564 updated to add Ruler in REG0086.
Also 46-017560, 46-017561, 46-017562, 46-017563 and 46-017564
updated to modify product name to “InnovaTM IGS 620” and “Inno-
vaTM IGS 630”.
61 March 4, 2015 46-017560, 46-017561, 46-017562, 46-017563 and 46-017564 up-
dated to introduce “Optima IGS 330” and change product name to
“Optima IGS 320”.
62 June 30, 2015 46-017561 updated to introduce tool p/n 5507803 for Optima IGS
systems.
46-017564 updated to introduce Magnus Maquet OR table for Dis-
coveryTM IGS 730 system.
63 July 5, 2017 46-017561, 46-017562, 46-017563 and 46-017564 updated to intro-
duce “InnovaTM IGS 5”, “InnovaTM IGS 6”, “DiscoveryTM IGS 7” and
“DiscoveryTM IGS 7 OR”.
64 October 15, 2019 46-017561 updated
10/18 HHS 46-013894 Revision 66


65 January 2021 46-017560, 46-017561, 46-017562, 46-017563 46-017564 updated
to introduce "Optima IGS Plus", "Allia™ IGS 7", "Allia™ IGS 7 OR" and
"Allia™ IGS Systems".
66 November 2021 46-017561, 46-017562, 46-017563 and 46-017564 updated to intro-
duce "Allia™ IGS 3" and "Allia™ IGS 5".
46-013894 Revision 66 HHS 11/18

Page intentionally left blank
System Field Test for HHS Contents
Contents
1 System Field Test for HHS.................................................................................................................15
1.1 Collector Table of Contents.................................................................................................................................................. 15
46-013894 Revision 66 HHS 13/18

1
1 System Field Test for HHS
1.1 Collector Table of Contents

Tab Document Number Rev Document Title
1 46–017559 3 HHS INTRODUCTION, OPERATING PLAN & TEST REQUIRE-
MENT TABLES
2 46–017560 19 HHS TOOLS
3 46–017561 33 HHS CONTROL & TUBE ASSEMBLY TESTS
4 46–017562 29 HHS BEAM QUALITY TEST
5 46–017563 36 HHS FLUORO SYSTEM TESTS
6 46–017564 28 HHS COLLIMATOR TESTS
7 46–017565 3 HHS MAMMOGRAPHY TESTS
8 46–017566 8 HHS FORMS, COMPLETING THE FDA 2579 AND GE DATA
RECORD FORMS
9 46–017567 3 HHS STENOSCOP TESTS
10 46–017568 3 HHS KITS – RENEWAL PARTS
11 2257181–100 1 HHS FIELD SIGNATURE TESTS
46-013894 Revision 66 HHS 15/18

General Electric Company
283, rue de la Minière
Buc 78530 FRANCE
www.gehealthcare.com
GE Healthcare
HHS
Introduction, Operating Plan and Test
Requirement Tables
OPERATING DOCUMENTATION
46-017559
Revision 3
HHS Introduction, Operating Plan and Test Requirement Tables
GE Healthcare Direction 46-017559, Revision 3
2
Important Information
LANGUAGE
Important Information 3
4 Important Information
This page left intentionally blank.
Revision History
Rev Date Reason for change Pages
0 Sept. 24, 1993 Initial release. -
1 Apr. 30, 1996 General revisions. -
2 Dec. 1, 1997 Revised to include hardcopy form references for third party users -
3 Dec. 20, 2007 Converted from Interleaf into e-CLS platform 48
Revision History 13
14 Revision History
Table of Contents
CHAPTER 1 SAFETY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.1 X-Ray Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.2 Certified Electrical Contractor Statement . . . . . . . . . . . . . . . . . . . . 18
1.3 Damage in Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
CHAPTER 2 OPERATING PLAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

1 This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
1.1 Background and Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
1.2 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
1.3 How To Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2 Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3 Mixing certified with non-certified Equipments . . . . . . . . . . . . . . . . . . . . . 24
4 FDA Requirements unique to Therapy Simulators . . . . . . . . . . . . . . . . . . . 25
CHAPTER 3 TEST REQUIREMENT TABLES . . . . . . . . . . . . . . . . . . . . . . . 27

1 Test Requirement Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
CHAPTER 4 FIELD FDA COMPLIANCE PLAN . . . . . . . . . . . . . . . . . . . . . . 31

1 Policy Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
2 Purpose and Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5 Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
6 Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
6.1 Documentation/Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
6.2 Equipment Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
6.3 Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.4 Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.5 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.6 Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.7 FDA and State Interactions . . . . . . . . . . . . . . . . . . . . . . . . . . 43
7 Performance Measurements and Quality Records . . . . . . . . . . . . . . . . . . . 44
Table of Contents 15
16 Table of Contents
Chapter 1 Safety
1 Safety
1.1 X-Ray Protection
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.
United States Federal law restricts this device to use by or on the order of
a physician.
If you have any comments, suggestions or corrections to the information in this document,
please write them down, include the document title and document number, and send them to:
GENERAL ELECTRIC COMPANY MEDICAL SYSTEMS
MANAGER – INFORMATION INTEGRATION,
AMERICAS W–622
P.O. BOX 414
MILWAUKEE, WI 53201–0414
Chapter 1 Safety 17
1.2 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.
1.3 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, WI (414) 827–3449 / 8*285–3449 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).
18 1 Safety
Chapter 2 Operating Plan

1 This Manual
1.1 Background and Purpose
A common point of confusion is that HHS regulations require specific tests or procedures.
Actually, tests and procedures are established by the manufacturer. They are the steps
that the manufacturer decides are necessary to state with full confidence (certify) that
performance standards are, and will continue to be satisfied.
This manual summarizes or references the tests required for certified equipment
manufactured by GE Healthcare.
Because it must cover a wide variety of products, this manual does not include specific
details of procedures such as terminal board numbers, etc. Specific information may be
obtained from service manuals for individual products. It is the responsibility of the assembler
to become sufficiently familiar with specific products so that the procedures given in this
manual may be properly executed.
The purpose of this manual is to support the manuals provided with equipment in several
ways:
• Emphasize the importance of HHS compliance procedures.

• Identify all required tests to ensure that none are overlooked.
• Cover details for procedures with broad applications.
• Identify procedures for required data collection.
THE ASSEMBLER MUST INSURE THAT ALL TESTS ARE PERFORMED WITH DUE
REGARD FOR APPROPRIATE RADIATION SAFETY PRECAUTIONS.
1.2 Application
This manual applies to all certified diagnostic X–Ray equipment. That is equipment with a
“certification plate” as part of the equipment rating plate.
A certification plate includes a statement such as:
“This product conforms to all applicable standards under 21 CFR, Part 1020”, or
“Complies with CDRH Radiation Performance Standard 21 CFR, Subchapter J”. (Older
certified equipment will refer to “DHHS” or “DHEW”.)
1.3 How To Use

The following illustration summarizes use of this manual.
Chapter 2 Operating Plan 19

Illustration 2-1: Summary of HHS Field Testing
The following list provides additional details and further definition on how to use this manual.
• Install equipment – Install equipment according to installation instructions provided

by the manufacturer.
• Identify required tests – Use Tables 1 through 7 in Chapter 3, Section 1, Test
Requirement Tables to identify required tests.
When servicing equipment, it is important to note if certification sensitive adjustments
are being affected. After completing repairs, perform appropriate tests to verify
that compliance is maintained.
• Perform required tests – For each required test, follow the procedure indicated.
Keep in mind that procedures in this manual apply to a broad range of products.
Always refer also to specific product and system instructions for additional details.
Also, in most cases, HHS tests (and data recording) are most easily completed
during, rather than after, installation adjustment and functional check procedures.
Again, refer also to specific product and system instructions for additional details.
20 1 This Manual
• Observe tolerances – The requirements for each test are restated as rejection limits
after taking into account measurement inaccuracies (e.g. meter accuracy tolerance).
Do not use tools that are less accurate than specified or are out of calibration.
• Number round–off – Record all significant digits in your data. Do not use round–off
“tricks” to make data fall within requirements. Note, however, that it is appropriate
to round–off the result of calculations: results should not reflect a greater accuracy
(more significant digits) than numbers used to develop the result. For example, if the
sides of a rectangle are measured to the nearest tenth (e.g., 2.1 and 1.1), the area
can only be stated to the nearest tenth (e.g., 2.3, not 2.31).
• Readjust or repair – If the performance does not meet the rejection limits given for a
test, readjust or repair the equipment as necessary. Refer to equipment instructions
for procedures. After readjust/repair of equip– ment, repeat compliance test. If
still not successful, inform your supervisor at once. Do not release element for
customer use.
• Record data – Record results for new installations on GE data record forms. When
replacing certified components, record results on Form 3382 or other appropriate
forms. Forms are available from A to Z Printing via E–mail – Common Forms –
“Forms.” See 46-017566 HHS Forms, Completing the FDA 2579 and GE Data Record
Forms, Chapter 1, Recording Data, for additional information. Sample forms are also
in 46-017566 HHS Forms, Completing the FDA 2579 and GE Data Record Forms. Be
sure to obtain all required information to complete forms before leaving site. Software
forms are found on the field laptop computer in the XRTOOLS window. Hardcopy
forms may be copied from 46-017566 HHS Forms, Completing the FDA 2579 and GE
Data Record Forms.
• Missing/unclear procedures – If any of the expected references or compliance
procedures are missing or unclear, inform your supervisor at once. Do not release
equipment for customer use.
• Unauthorized Modifications – If the customer requests modifications in the
installation, or tests that are not authorized by the manufacturer’s instructions, and
such modifications would cause the equipment to become non-compliant when tested
according to the manufacturer’s instructions, inform your supervisor at once. Do
not modify the equipment.
• Federal and State Reports – For new installations, immediately complete required
State and Federal forms. Federal Form 2579 must be sent to HHS within 15
days of availability for customer use.
NOTE: DO NOT REPORT:
1. X-Ray tube replacements of any type;

2. Accessory components (certified items that do not require calibration to ensure
compliance, and that are interchangeable with identical items or among various X-Ray
systems without affecting compliance, such as additional beam limiting diaphragms
or a mammo Bucky);
3. Repair of a certified component, unless the component was replaced.

2 Terminology
The names of tests in this manual have, in some cases, been made more specific than in
the HHS regulation.
Terminology here is similar to that used in the HHS regulations. Paragraph 1020.30B
contains a complete list of definitions; highlights are listed here.
Beam Limiting Device – Collimator or cone to define X–Ray field.
Cone – Fixed aperture beam limiting device.
Coefficient of Linearity, (C.L.) – The ratio of the difference and the sum of the average
values of mR/mAs, obtained at each of two consecutive tube current settings. Defined as
“average exposure ratios” by HHS.
Where 1 and 2 are the average of ten mR/mAs values obtained at each of two
consecutive tube current settings, and mAs is the selected mAs.
Coefficient of Variation, (C.V.) – The ratio of the standard deviation to the mean value of a set
of 10 observed exposure values.
where s = standard deviation of sample
= mean value of exposures in sample
Xi = ith observed value of exposure
n = number of observations, (10)
Diagnostic Source Assembly – X–ray tube unit, with beam limiting device attached.
Half–Value Layer (HVL) – Thickness of Type 1100 aluminum which causes the X–Ray
beam to be attenuated by 50%.
Image Receptor – Any device, such as fluorescent screen, image intensifier input face, or
radiographic film, which transforms X–rays into a visible image.
Inherent Filtration – Thickness of Type 1100 aluminum which would cause the same
attenuation of the X–Ray beam as is caused by other materials permanently in the beam,
such as X–ray tube window, collimator mirror, etc.
Manufacturer – Manufacturers and assembles equipment at factory site. For diagnostic

X-Ray sources only, replacement of tube inserts in certified casings is also considered
manufacture, even though not done at factory.
22 2 Terminology
Positive Beam Limiting (PBL) – Collimator system which automatically limits the X-Ray field
to the size of the image receptor or prevents exposure unless the X-Ray field is limited to
the size of the receptor.
Source Image Distance (SID) – Distance from X–Ray tube focal spot to film or to image
intensifier input face.
Type 1100 Aluminum – Alloy with 99% AL and .12% maximum CU.
Visible Area – That portion of input surface of image receptor over which an incident X-Ray
beam produces a visible image. For example, that portion of image intensifier input phosphor
which is visible on monitor during test exposure with shutters wide open.
X-Ray Field – Cross-section of X-radiation normal to the X–Ray beam axis controlled by
collimator or cone.

3 Mixing certified with non-certified Equipments

FDA regulations permit unlimited mixing of certified and uncertified components in new
or reassembled systems.
NOTE: Beware: Individual states may prohibit such mixing or may require the uncertified equipment
to meet the same standards of the certified equipment. Also, since GEHC has always
assumed that uncertified equipment could not be added to certified equipment, there may
be no interface direction for such combinations. It is still illegal to install equipment without
adequate assembly instructions. Do not assume that the new FDA regulations will make
possible something that was previously impossible.
24 3 Mixing certified with non-certified Equipments

4 FDA Requirements unique to Therapy Simulators

Therapy simulators are exempt from most of the FDA regulations that affect diagnostic X–ray
systems. There are only three requirements that we need to deal with. These are as follows:
1. “The aluminum equivalent of the radiation therapy simulator tabletop must not exceed
5.0 millimeters.” (The spec for diagnostic tabletops is 2.0 mm).
2. “Radiation therapy simulator systems are exempt from the primary protective
barrier requirement provided the systems are intended only for remote control
operation and the manufacturer sets forth instructions for assemblers with
respect to control location as part of the information required to be provided to
assemblers in section 1020.30(g). Additionally, the manufacturer must provide
to users precautions concerning the importance of remote control operation as
part of the instructions concerning any radiological safety procedures which
are required by section 1020.30(h) (1) (i).”
3. “As an alternative to the requirement for a fluoroscopic timer, radiation therapy
simulation systems may be provided with a means to indicate the total
cumulative exposure time during which X–rays were produced, and which is
capable of being reset between X–ray examinations.”

26 4 FDA Requirements unique to Therapy Simulators

Chapter 3 Test Requirement Tables

1 Test Requirement Tables
Table 3-1: HHS Tests required for most new Installations / Relocations
Common Tests - Apply to all systems except mammo units and the stenoscop
Use Data Record Form 3382 (use 3382MX for AMX/VMX)
For instructions, see Direction 46–013894

Control and Tube Assembly Tests 46-017561 HHS Control & Tube Assembly Tests
- Generator Operator Indicators 46-017561 HHS Control & Tube Assembly Tests
- Technique Accuracy – Timer (1) 46-017561 HHS Control & Tube Assembly Tests
- Technique Accuracy – kV/mA 46-017561 HHS Control & Tube Assembly Tests
- Technique Accuracy – mAs (2) 46-017561 HHS Control & Tube Assembly Tests
- Indirect Linearity (3) 46-017561 HHS Control & Tube Assembly Tests
- Direct Linearity (4) 46-017561 HHS Control & Tube Assembly Tests
- Reproducibility of Exposure (5) 46-017561 HHS Control & Tube Assembly Tests
- AEC Maximum mAs (5) (6) 46-017561 HHS Control & Tube Assembly Tests
- AEC Minimum Exposure Time (5) 46-017561 HHS Control & Tube Assembly Tests
Beam Quality Test (Half Value Layer) 46-017562 HHS Beam QualityTests
Collimator Tests (7) 46-017564 HHS Collimator Tests
NOTE: 1. All controls except those having only mAs selection.

2. All controls that allow mAs selection, even if time selection is also available.
3. All systems that allow two or more selections for radiographic, spot–film (including
integral film changer), photospot mA or mAs.
4. Used to verify compliance in the event of failure of the indirect Linearity Test.
5. Does not apply to any application involving an image intensifier.
6. Applies during normal operation, not during equipment failure.
7. Refer to Table 3-4 for specific test requirements.
Table 3-2: Additional HHS Tests for Fluoro/Vascular Installations / Relocations
Fluoro Tests - Apply to Fluoro Portion of R&F Systems and all Vascular Systems
Use Data Record Form 3382
Fluoro Entrance Exposure Rate 46-017563 HHS Fluoro System Tests
Primary Barrier Transmission 46-017563 HHS Fluoro System Tests
Undertable Tube Leakage Radiation (1) 46-017563 HHS Fluoro System Tests
Fluoro Interlock (2) 46-017563 HHS Fluoro System Tests
Chapter 3 Test Requirement Tables 27

NOTE: 1. Applies only to tubes mounted inside of a table.

2. Refers to the interlock switch at the rear of a spot–film device.
Table 3-3: HHS Tests for Mammography Units or the Stenoscop
Mammography or Stenoscop Tests
Use Form 3382MM for Mammo, 3382SS for Stenoscop

All Mammography Tests 46-017565 HHS Mammography Tests
All Stenoscop Tests 46-017567 HHS Stenoscop Tests
NOTE: In the following table, read across in the rows labeled “Systems Types” and “examples” to
determine which column applies to your system.
Table 3-4: HHS Tests for Collimators (Notes 1, 2)
System Types Auto Coll. Auto Coll. to Auto Coll. to Auto Coll. to Man. Coll. to Man. Coll. to Cone/Cyl. to
to Bucky or SFD I.I. (Fluoro) Film Changer any Recep. Mobile X–ray any Receptor
Cass. (3)
Examples XT RFX/SFX, RFX/SFX, Integral film Table top film, AMX, VMX Tube Stand
Suspension, Stenoscop (6) Vascular, changers such free standing
Tube Stand Remote Table, as AFM or L–U film changers
Remote Table Stenoscop (6)
(5)
Test Required
SID X X
Light to X–ray X X X
Center to X X X X(7) X(4)(7)

Center
Field Size X X X(4)
Indicators
Size to Size X X X
Lamp X X X
Brightness
Image Overlap X
Fluoro Coll. to X
I.I.
NOTE: 1. All collimators require functional tests; see Chapter 2 of 46-017564 HHS Collimator
Tests.
2. Mammo collimator tests are covered under 46-017565 HHS Mammography Tests.
3. Does not include mobile X-ray units (AMX and VMX).
4. These are required by many state agencies but not by the FDA.
5. The Bucky of a remote table is similar to a SFD, and so the centering test is that of a
SFD. See Chapter Center to Center Test for SFD of 46-017564 HHS Collimator Tests.
6. The stenoscop is a C-Arm with a SFD (optional).
7. Centering requirements will be met provided the X-ray and light fields are aligned and
the cross-hairs are centered in the field.
28 1 Test Requirement Tables

Table 3-5: HHS Tests Requirements when replacing tube unit on most systems (FDA 2579
Form not required)
Common Tests - Apply to all systems except mammo units and the stenoscop
Use Data Record Form 4285 (1) (use 3382MX for AMX/VMX)

Control and Tube Assembly Tests 46-017561 HHS Control & Tube Assembly Tests
- Generator Operator Indicators 46-017561 HHS Control & Tube Assembly Tests
- Technique Accuracy – kV/mA 46-017561 HHS Control & Tube Assembly Tests
- Indirect Linearity (2) 46-017561 HHS Control & Tube Assembly Tests
- Direct Linearity (3) 46-017561 HHS Control & Tube Assembly Tests
Beam Quality Test (Half Value Layer) (4) 46-017562 HHS Beam QualityTests
Fluoro Tests 46-017563 HHS Fluoro System Tests
- Fluoro Entrance Exposure Rate 46-017563 HHS Fluoro System Tests
- Undertable Tube Leakage Radiation (5) 46-017563 HHS Fluoro System Tests
- SFD Park Fluoro Interlock 46-017563 HHS Fluoro System Tests
Collimator Tests 46-017564 HHS Collimator Tests

- Light to X-ray 46-017564 HHS Collimator Tests
- Center to Center (for SFD only) 46-017564 HHS Collimator Tests
- Fluoro Collimator to Image Intensifier 46-017564 HHS Collimator Tests
NOTE: 1. Testing is mandatory, but completion of Form 4285 is optional, except for VA or
DOD accounts.
2. All systems that allow two or more selections for rad., spot-film (including integral
film changer), photospot mA or mAs.
3. Used to verify compliance in the event of failure of the Indirect Linearity Test.
4. Test is mandatory for Fluoro, but optional for Rad. If replacement tube carries same
basic 46–xxxxxx number.
5. Applies only to tubes mounted inside of a table.
Table 3-6: HHS Tests when replacing Tube Unit on Mammo or Stenoscop Unit (FDA 2579 Form
not required)
Mammography or Stenoscop Tests
Use Data Record Form 3382MM for Mammo, 3382SS for Stenoscop

Mammo Unit Tests (1) 46-017565 HHS Mammography Tests
Stenoscop Tests (2) 46-017567 HHS Stenoscop Tests
Chapter 3 Test Requirement Tables 29

NOTE: 1. Perform all 46-017565 HHS Mammography Tests tests except Generator Operator
Indicators and Reproducibility.
2. Perform kV/mA and mAs Accuracy, Beam Quality, Entrance Exposure Rate, and
Fluoro Collimator to Image Intensifier Tests.
Table 3-7: HHS Tests required when replacing / adding certified components other than tubes
(FDA 2579 form required)
Component Replaced Tests Required and Location Data Record Form
Collimator All of Table 3-4 except SID 46-017564 HHS Collimator Tests (1) 3382 (2)
Transformer kV/mA Accuracy 46-017561 HHS Control & Tube Assembly Tests (1) 4285 (2)
Indirect Linearity 46-017561 HHS Control & Tube Assembly Tests 4285 (2)
Flu. Ent. Exp. Rate 46-017563 HHS Fluoro System Tests (3) 4285 (2)
Table Top None. Verify Rating Plates
Table – Rad only All tests of Table 3-4 46-017564 HHS Collimator Tests 3382
Table – R&F All tests of Table 3-4 46-017564 HHS Collimator Tests 3382
Undertable Tube Leakage 46-017563 HHS Fluoro System Tests 3382
SFD Park Fluoro Interlock 46-017563 HHS Fluoro System Tests 3382
Table Bucky – Rad All of Table 3-4 except SID 46-017564 HHS Collimator Tests 3382
Mammo Bucky None (4)
Wall Bucky or Cass. Hldr. All of Table 3-4 46-017564 HHS Collimator Tests 3382
Master Control See Note 5
NOTE: 1. 46-017565 HHS Mammography Tests for Mammo Units, 46-017567 HHS Stenoscop
Tests for Stenoscop.
2. Use the MM, MX, or SS versions of Form 3382 for special systems as appropriate.
3. 46-017567 HHS Stenoscop Tests for Stenoscop.
4. Chest wall image overlap applies, but if the system was compliant before the Bucky
was added, then it will remain compliant after the Bucky is added.
5. When replacing the plasma display of the Advantx (master control) there are no
test requirements. For other master controls all of Table 3-1 plus fluoro entrance
exposure rate and minus the collimator and HVL tests may apply. Contract Region
Compliance Engineer.
DON'T FORGET TO COMPLETE FDA FORM 2579
30 1 Test Requirement Tables

Chapter 4 Field FDA Compliance Plan

1 Policy Statement
It is the goal of GE Healthcare to maintain the highest level of compliance with HHS
regulations pertaining to diagnostic imaging equipment in the Field. To this end GE has
established a systematic program of testing, reporting, auditing and training. This document
is the basis of GEHC’ HHS plan.
Chapter 4 Field FDA Compliance Plan 31

2 Purpose and Scope

FDA regulations require that assemblers of diagnostic X–ray and CT imaging equipment
affirm that installed equipment complies with the standards set forth in the Code of Federal
Regulations (CFR). These regulations comprise a set of performance standards meant to
ensure the safety of patient and operator. Title 21 CFR Parts 1020.30 to 1020.33 define the
performance standards and associated test conditions for diagnostic X–ray and computed
tomography (CT) systems.
Radiation Therapy Simulators are also reportable, though the performance standards are
very different from those for other machines, (see Chapter 2, Section 4, FDA Requirements
unique to Therapy Simulators).
The FDA regulations require that equipment be installed and tested according to the
manufacturer’s instructions, that all applicable performance standards be met, and that the
assembler complete FDA Form 2579. In addition, Form 2579 must be completed prior to
releasing the equipment for use on patients, and copies are to be sent to the FDA, to the state
health agency, and to the customer. The performance standards and reporting requirements
apply to new installations and to replacement Certified Components for equipment that is
sold, leased, or on loan to the customer.
There are no field testing or reporting requirements for a unit that is not intended to be used
on live human patients, such as a mobile system set up in a field service office for use solely
as a field service training aid, a veterinary unit, or a tissue specimen analyzing machine.
The procedures in this document define standard processes used by GEHC Field Service to
ensure compliance with the FDA regulations.
The FDA regulations relevant to GEHC business are often cited as 21CFR Subchapter J.
32 2 Purpose and Scope

3 Definitions
1. Assembler: The person who installs, replaces, or repairs components of an X–ray
or CT system. Only those assemblers who have demonstrated proficiency (refer to
Section 5, Responsibilities, 1, b) in HHS procedures may submit HHS paperwork,
including form FDA 2579 (see below).
2. Administrative Assistant: The person responsible for logging HHS paperwork and for
distributing the various copies of form FDA 2579. This person may be a secretary,
data base analyst, clerk, or other person designated by the Region HHS Coordinator.
3. Certified Component: An assembly of parts identified as certified in the GE drawing
system, subject to the regulations of 21 CFR Parts 1020.30 to 1020.33 (performance
spec.), and carrying a label similar to the following:
4. “Complies with Radiation Performance Standard 21 CFR subchapter J.”
5. CFR 21: The Code of Federal Regulations, Title 21, within which the FDA specifies
the minimum performance for diagnostic X–ray and CT systems. See FDA
performance spec below.
6. CIMS: Course Information Management System – a data base of employee training
records maintained by the GE Healthcare Institute.
7. Data Record Form: Any of several forms that GE uses to record Field data from HHS
compliance tests specified either in the product’s service manual or in Direction
46–013894.
8. FDA performance spec: The performance standards and associated test conditions
found in the CFR Title 21 Parts 1020.30 to 1020.33. Manufacturers must certify that
their equipment will meet the relevant FDA performance spec.
9. Field FDA Compliance Plan: This document shall serve as the HHS Compliance Plan
for each region. It may be enhanced by the addition of specific details created to
accommodate each region’s particular requirements. When so enhanced, it shall
be known as the xxxx Region HHS Compliance Plan, and it shall incorporate all of
the features of this document.
10. Form FDA 2579: The federal form used to report installations of certified diagnostic
X–ray (inc. Therapy Simulators) and CT systems, or replacement of certified
components in those systems. Only certified components are listed on the form, but
it applies to new, used, or relocated equipment. The form must be completed and
signed by the Assembler, and filed with the FDA within fifteen days of the equipment’s
availability for use on patients.
11. HHS: The Department of Health and Human Services. The FDA is a section of this
department. GE often uses HHS to refer to FDA issues.
12. Noncompliance: Failure of an X–ray or CT system to meet some portion of the FDA
performance spec when tested by the FDA or their subcontractor.
13. Product Locator Form: An internal form used to document the location of each
product sold or leased by GEHC. The need for a Product Locator system is
established by 21 CFR 1002.40 and .41.
14. Region Compliance Coordinator (RCC): The person having responsibility for
coordination of the Field FDA Compliance Plan (see above) activities in his/her
region. This person may have the title Region Compliance Engineer, HHS Manager,
or Region HHS Coordinator.

15. Notice Of Noncompliance (NON) Letter: A letter issued by the FDA and identified
(typically across the top of the letter) as a NON Letter. The letter will document the
FDA’s discovery of one or more noncompliances at a given site. The letter will
include customer and equipment data, a reference to the specific item(s) of the FDA
performance spec. that the system fails to meet, and usually some test data. The
letter will be addressed to the office listed under item 2 on form FDA 2579. Resolution
of the noncompliance(s) and a written response, is required within the time frame
specified in the NON Letter. The FDA may initiate legal action without further notice if
the NON Letter does not receive a timely response.
34 3 Definitions
4 References
1. Direction 46–013894: “System Field Test for HHS.” A controlled document containing
basic instructions for performing the field tests required to ensure compliance with the
FDA performance spec. When more detailed instructions are required to carry out a
particular test on any given product, those instructions are given in that product’s
service manual. This direction is available through Direction Stock and may be
ordered via common forms “Tech Pubs” on the mainframe.
2. Form FDA 2579: The federal form used to report the installation of certified diagnostic
X–ray and CT systems, or the replacement of certified components in those systems.
Only certified components are listed on the form, but it applies to new, used, or
relocated equipment. The form must be completed and signed by the Assembler, and
filed with the FDA within fifteen (15) days of the equipment’s availability for use on
patients. This form is available only from the FDA (Government Printing Office); do
not copy. Obtain from the Administrative Assistant or RCC.
NOTE: As of September 1995 an on–line version of the 2579 form was pending FDA approval.
3. Data Record Forms include the following: (these are GE forms)
a. F3382 – used for core X–ray Rad, R & F, and Vascular systems for new installation
or component replacements.
b. F3382MM – used for Mammographic systems
c. F3382MX – used for mobile X–ray units
d. F3382SS – used for the Stenoscop
e. F4567 – used for CT installations

5 Responsibilities
The RCC and Administrative Assistant shall each designate a backup individual to assume
their responsibilities during their absence, and shall advise all concerned individuals of
the names of the backups.
1. Region HHS Coordinator: The RCC shall have overall responsibility for the Region
HHS Compliance Plan. Specific areas of responsibility include:
a. Training: Provide for the HHS training of all X–ray and CT assemblers in the
Region. Provide for refresher classes for all such personnel on a maximum three
year cycle. The RCC shall bar an assembler from submitting HHS paperwork if, in
his or her opinion, said assembler fails to demonstrate adequate proficiency (see
next paragraph) in testing or documentation. The RCC will provide support to the
Assemblers on matters concerning compliance with the FDA performance specs.
The RCC shall arrange for training records to be maintained on the CIMS.
b. Assembler Proficiency: An Assembler must maintain proficiency in testing and
reporting in order to comply with FDA regulations and in order to be permitted to
submit HHS paperwork. Lack of proficiency will be evidenced by a failing score in
any GEHC administered HHS test or by a history of errors in completing HHS
paperwork. The RCC shall provide special training for any Assembler barred from
submitting HHS paperwork due to lack of proficiency.
c. Auditing: Periodically audit the files of FDA 2579 and Data Record Forms
completed by the Assemblers. Minimum requirements are audits on a quarterly
basis, and review of 10% of the records. Reconcile errors with the responsible
Assemblers. Provide for the retesting of at least one representative
Provide for the retesting of at least one representative customer site in each major
city, customer center, or Local Customer Team (LCT) area within two months of
release to customer. In the event of a confirmed noncompliance, resulting in an
FDA letter, The RCC shall arrange for a site audit of a similar installation in the
same general area. Document audit results and corrective actions taken, and
retain these records per item d. below. As an alternative to quarterly form and
record audits, the Region HHS Coordinator may elect to review each 2579 form
and data record prior to it’s being filed.
d. Record Keeping: Maintain the following records at Region designated filing
locations:
i. Form FDA 2579 (minimum retention: 5 yrs).
ii. Data Record Forms (minimum retention: 1 yr).
iii. Product Locator (minimum retention: 1 yr).
iv. NON Letters (minimum retention: 1 yr).
v. HHS Training (minimum retention: FE’s career as Assembler)
vi. Audit & corrective actions (minimum retention: 5 yrs).
vii. Late paperwork records (minimum retention: 5 yrs).
viii. FDA audits (minimum retention: permanently)
ix. Copy of xxx Region HHS Plan (minimum retention: permanently)
The above records are to be filed by calendar year. Retain the current year’s
records, in addition to the number of years listed above.
36 5 Responsibilities
e. FDA/State/Local interactions: Review all FDA NON Letters, memos, and phone
calls, and similar communications from state or local health agencies, and provide
for appropriate investigation as described in Section 6, Procedures, section FDA
and State Interactions. Prepare written responses within the time frames specified
in the communications. Report all NON Letters, except those that are obvious
Assembler or inspector errors, as FPRs.
f. Reports: Provide quarterly reports to the Region concerning the status of the
Region HHS Program. The reports should include information on the status of
NON Letters or similar communications, results of audits, training activities, and
corrective actions taken or proposed.
2. Assembler: Specific responsibilities include:
a. Installation: Install and test equipment according to the manufacturer’s
instructions. Do not modify equipment when such modification would adversely
affect ability to meet FDA performance spec. Company policy forbids modification
of GEHC equipment, or connection of GEHC equipment to non–GEHC
equipment without prior approval of Marketing. Ensure that combinations of
components installed into one system have been identified as ”compatible” by
the manufacturer(s), or have otherwise been determined to be appropriate by
the RCC or headquarters personnel.
b. Testing: Perform all the tests called for in Direction 46–013894 for each certified
component installed, replaced, or repaired. All certified components must meet
the FDA performance spec as noted in Direction 46–013894; adjust or repair as
necessary. Do not release equipment to the customer until system has passed all
required tests.
c. Documentation/Forms: Record the results of all tests on the appropriate Data
Record Form, e.g. use form 3382MM for mammography units. Where calculations
are required, these must be included. Return completed documents to the
individual specified by the RCC for processing. Form FDA 2579 must be returned
in time for processing and forwarding to the FDA within 15 days of releasing the
equipment to the customer.
3. Administrative Assistant: Specific responsibilities include:
a. Logging: Log receipt of 2579 and Data Record Forms from Assemblers.
b. Tracking: Use the above log and a transfers report to track the progress of
paperwork, ensuring that all 2579 forms are processed and distributed within 15
days of equipment being released to the customer. See Section 6, Procedures,
section Record Keeping, Administrative Assistant.
c. Processing: Review the 2579 forms, ensuring that key information, i.e. customer
and assembler addresses, assembly date, signature and signature date are all
present. Check that signature date is within 15 days of assembly date. Resolve
any problems by contacting Assembler, Region HHS Coordinator, or Area Service
Manager in a timely fashion, thus ensuring that 15 day filing deadline is met. File
all HHS paperwork and include a copy of the Product Locator information.
d. Distribution: Distribute copies of the Form FDA 2579 to the FDA, to the state
health agency, and to the customer. Forward the Product Locator cards to Product
Locator at mail code W523 or to the address shown on the cards.
e. Forms: Maintain supply of current Data Record Forms (available from A to Z
Printing – see “Forms” under Common Forms on E–Mail) and Form FDA 2579

(see 46-017566 HHS Forms, completing the FDA 2579 and GE Data Record
Forms for ordering information on Form FDA 2579).
f. FDA and state health agency communications (NON Letters etc.): Any such
communications are to be delivered immediately to the RCC or to the designated
backup or to the Area Service Manager. Verify that the intended recipient actually
received the material, i.e., do not leave in an in–basket and walk away.
4. Region Service Manager: Specific responsibilities include:
a. Providing the staff and support necessary to fulfill the requirements of this Field
FDA Compliance Plan.
b. Access the performance of each individual responsible for executing this Plan,
and take corrective actions as indicated to ensure proper performance, as outlined
in Section 7, Performance Measurements and Quality Records.
38 5 Responsibilities
6 Procedures
6.1 Documentation/Forms
1. Assembler:
a. Prior to testing, assemble required forms, i.e. FDA 2579 and appropriate Data
Record Form. Obtain forms from office supply (see Administrative Assistant or
Region HHS Coordinator). Data Record Forms may be photocopied from Dir.
46–013894.
b. During testing, record all data required by Data Record Forms, Dir. 46–013894,
and product’s service manual. Wherever required, provide calculations.
c. After testing is successfully completed fill out Form FDA 2579 using the examples
in 48-017566 HHS Forms, Completing the FDA 2579 and GE Data Record Forms
of Dir. 46–013894 as a guide. Use Product Locator information to ensure that
all certified components are properly reported, or verify model numbers prior to
leaving site. Assembler address is the office where the HHS files are maintained.
Sign and date the form. Note that the signature date should be the same as the
”Date of Assembly” (refer to chapter SAMPLE 2579 FORMS of 46–017566, HHS
FORMS, COMPLETING THE FDA 2579 AND GE DATA RECORD FORMS)
since we do not consider the system to be completely assembled until the HHS
testing is completed. A discrepancy of more than 15 days in these two dates is a
violation of federal law and requires a letter to the FDA. Return completed Form
FDA 2579, Data Record Form, and Product Locator cards to the Administrative
Assistant within five days.
2. Administrative Assistant:
a. Review the 2579 form, ensuring that key information, i.e., customer and
Assembler addresses, assembly date, signature and signature date are all
present. Check that signature date is within several working days of assembly
date (refer to chapter SAMPLE 2579 FORMS of 46–017566, HHS FORMS,
COMPLETING THE FDA 2579 AND GE DATA RECORD FORMS). Resolve
any problems by contacting Assembler, RCC, or Area Service Manager in a
timely fashion, thus ensuring that the 15 day filing deadline is met. File all HHS
paperwork and Product Locator information.
b. Distribute copies of the 2579 form to the FDA, to the state health agency, and to
the customer. It is recommended that a letter accompany the customer’s copy,
advising them to keep this copy on file, and also advising them of the need for them
to register X–ray equipment with the state health agency. The RCC can provide
text for this letter. Forward the Product Locator cards to Product Locator W523.
6.2 Equipment Testing

Applies to sold, leased, or loaned equipment. Does not apply to equipment not used on
live patients.
1. Assembler:
a. Prior to testing, assemble all the required HHS test equipment called out in
Direction 46–013894 and in the product’s service manual. Ensure that each piece
of test equipment is within its calibration cycle, as evidenced by a tag on the

equipment or data in the test equipment data base on the main frame computer
(RCC can assist if necessary).
b. Perform all the tests called for in Direction 46–013894 for each certified component
installed, replaced, or repaired. This applies to sold, leased, or loaned equipment.
For CT systems, or, if the generic instructions of Dir. 46–013894 are not sufficient,
refer to the equipment’s service manual. If necessary, request help from the RCC.
All certified components must meet the FDA performance specs as noted in
Direction 46–013894 (or the service manuals); adjust or repair as necessary. Do
not release equipment to the customer until system has passed all required tests.
2. Region HHS Coordinator–Refer to Section 6.6 , Step 1.c.
6.3 Reporting
1. Region HHS Coordinator: Provide quarterly reports to the Region Service Manager,
Area Service Manager, etc., on the following topics:
a. NON Letter status
b. Late HHS paperwork
c. Results of Audits
d. Training schedules, conflicts
e. Corrective actions taken or proposed
2. Administrative Assistant: In the event an Assembler has not submitted a Form FDA
2579 within five days of the date a system was known to have been transferred or
otherwise made available for use by the customer, the Administrative Assistant shall
forward a message to the Assembler requesting immediate delivery of the paperwork.
Paper copies of this message shall also be delivered to the RCC and to the Area
Service Manager. If the message was by voice mail, the Administrative Assistant shall
send memos to document the message.
6.4 Record Keeping

1. Region HHS Coordinator: The RCC shall designate the Field Office(s) where HHS
files will be maintained, and will name an individual to maintain the files. The following
files will be maintained:
a. Form FDA 2579: File these forms by calendar year and alphabetically. Further
breakdown by customer or FDO is optional. Records must be retained for five
fiscal years in addition to the current year, and the current year should be in
a separate file.
b. Data Record Forms: These are to be filed with the associated Form FDA 2579.
The FDA requires 14 months of record retention, so for convenience, the files may
be purged of such records every other year. Films are not required to be retained
for any period. Since tube replacement data records, without associated FDA
2579 forms, will make up the bulk of the file, the tube replacement data records
may be kept in a separate part of the file to improve organization.
c. Product Locator: This record should be retained with the associated Form FDA
2579 to assist in auditing, or in the event an error was made in filling out the form.
There is no FDA requirement to retain hard copy of this record in the field office,
but it is required to facilitate auditing by the RCC or by Headquarters.
40 6 Procedures
d. Notice Of Noncompliance Letters: Log all NON letters onto the GEWINS system
or FPRs. Include date of letter, date received, customer, and brief description
of complaint. Copies of response letters should be sent to FDA, customer, and
QSR–W709 M.A. Chilbert and HHS Support–W595 E.V. Polizzi.
e. HHS Training: Training records will be maintained for all Assemblers in the
Region. The records will be maintained on the CIMS. HHS records are found
under the major heading “ES”.
f. Region HHS Program: A copy of this program should be available to each
Assembler in his/her field office. The RCC must maintain and make available an
up–to–date hard copy.
2. Administrative Assistant:
The Administrative Assistant shall maintain a log (often called a tracking log) of
pending installations and the dates these are projected to be available for customer
use, (typically, this information can be provided by the installation manager). This
log will be based on information on government and non government systems and
certified component replacements, provided by the RCC. The Administrative Assistant
will use this log to determine the due dates of HHS paperwork from the Assemblers
assigned to that office. See Section 6.3 , Step 2.
6.5 Training
1. Region HHS Coordinator: The RCC shall provide for refresher classes for all X–ray
and CT Assemblers in the Region on a maximum three year cycle. The course text
shall be the HHS Field Refresher Course. Local enhancements of the material in said
text are permissible. Training of new hires or other individuals who have not received
adequate HHS training, shall be the responsibility of the GEHC Institute. The RCC
shall bar any Assembler from submitting HHS paperwork if, in his or her opinion, said
Assembler fails to demonstrate adequate proficiency in testing or documentation
(see Section 5, Responsibilities, Step 1.b.). The RCC shall provide support to the
Assemblers on matters concerning compliance with the FDA performance specs.
See also Section 6.6 , Step 1.b.
2. Assembler: Assemblers shall report for training scheduled by the RCC.
3. Managers: Management shall negotiate a training schedule with the RCC which
ensures that he/she can provide adequate training for all Assemblers on a maximum
three year cycle. In the case of new hires or other individuals who have not received
adequate HHS training, management shall adjust that individual’s schedule so that
training can be provided by the GEHC Institute in a timely fashion.
6.6 Auditing
The RCC shall conduct periodic administrative and site audits to ensure that the objectives
and purpose of this plan are being met.
1. Administrative audits:
a. Form FDA 2579: Files of 2579 and Data Record Forms shall be audited quarterly.
Audit at least 10% of the previous quarters records. Review each form for
accuracy regarding especially the model numbers, manufacturers’ names,
assembler address in item 2 of the form, and signature and assembly dates.
Compare form information with Product Locator data to see if all certified items
have been reported and are in the proper boxes. Note that model and serial

numbers are not required in the comments section. Also note that numbers, not
check marks, are required in item 4.g of the form. Record errors and resolve with
Assembler. In the event of gross errors, submit an amended Form FDA 2579
and reference the original form serial number in the comments section. As an
alternative to quarterly audits, the RCC may elect to review each 2579 form and
data record prior to it’s being filed.
b. Data Record Forms: Review Data Record Forms associated with above 2579s
and also Data Record Forms where no 2579 may have been submitted, (e.g.
tube replacement). Verify that all required tests were performed and that data
indicates a clear understanding of Dir. 46–013894. Record errors and resolve
with Assembler.
c. Test equipment calibration due dates: In conjunction with above, verify that
test equipment listed on Data Record Forms was within calibration cycle at
the time of the testing.
d. Review all errors with the responsible FEs.
e. Retain a record of all audit results and corrective actions taken for 5 fiscal years in
addition to the current year.
2. Site audits:
Throughout the course of the year, select representative customer sites for auditing.
At least one site in each major city, customer center, or Local Customer Team
(LCT) area is to be thus audited. The retesting (auditing) should be performed as
soon as possible after completion of testing by the Assembler and not later than
two months thereafter.
The site audit should cover, as a minimum, the following HHS tests:
• All collimator tests
• Beam Quality (Half Value Layer) test(s)
• Primary Barrier Transmission (except mammo)
• Non-invasive spot check of kV accuracy
• Exposure rate
In the event than an FDA letter results in a confirmed noncompliance, and whether
the Assembler is at fault or not, an additional site audit shall be conducted in the
same general area ASAP.
Compare results of the audit with the original test data submitted by the Assembler,
resolve inconsistencies with the Assembler. Retain a record of all audit results and
corrective actions taken for 5 fiscal years in addition to the current year.
3. FDA audits:
a. In the event of an FDA audit, the first person in contact with the FDA auditor,
should call the RCC and the Area or Region or Tech. Ops. Manager. At least
one manager must be present during the audit; the RCC (or the person the
RCC has designated to maintain the HHS files) should also be present. If at
least one manager is not available, ask the FDA investigator to reschedule the
audit. If this is not acceptable to the auditor, call GEHC legal counsel. Audits
may only be conducted during normal business hours, other arrangements must
be made in advance.
b. The auditors should present identification and a written notice of intent to inspect.
It is appropriate to request these if they are not volunteered. Record the auditor(s)
name(s) identification numbers and home office.
42 6 Procedures
c. Advise the auditor of any action they initiate that conflicts with GEHC policy. If
they persist, or state they consider this a refusal to permit inspection, suspend the
investigation and call GEHC legal counsel.
d. Retain a record of the auditor’s findings and your responses and corrective
actions in a permanent file.
6.7 FDA and State Interactions

The RCC will participate in, or be advised of, all FDA and state interactions. The RCC
should take an active role in developing a cooperative relationship with local FDA and
State inspectors. A good working relationship will minimize misunderstandings and may
reduce paperwork. The RCC will process and respond to all NON Letters and similar
communications from the state health agency, and to any informal communications, such
as phone calls from these agencies, that relate to noncompliances. A typical process flow
chart for responding to these communications is shown at the end of this document The RCC
must respond to the NON Letter or other communication within the time frame specified,
as failure to do so could result in legal action against GEHC. It is therefore imperative
that all administrative and clerical personnel be advised to personally deliver any such
communication immediately to the RCC or to the designated backup or to the Area Service
Manager, refer to Section 5, Responsibilities, Step 3. f.

7 Performance Measurements and Quality Records

Measurements are to be administered by the Region manager.
For this plan the key measurements are:
1. NON Letters: Zero NON letters is the goal. Letters involving obvious inspector errors
or documented Manufacturing or Engineering problems do not count against the total
for Region performance assessment.
2. Form FDA 2579: Late submissions (beyond the fifteen day filing window) represent
a violation of federal law and must be kept to an absolute minimum. Zero late
forms is a goal.
3. Training: A comprehensive HHS refresher training program should be established.
The basis of the course shall be the HHS Field Refresher Course text. This text, and
accompanying video is available from the Medical Systems Institute. Requirement is
to achieve 100% training of Assemblers in the Region with a maximum 3 year cycle.
4. HHS Files: Administrative audits by both the RCC and by headquarters will assess
the quality of these files. Form FDA 2579 and Data Record Forms should be accurate.
Goal is to have no more than 5% with any significant error.
5. Site Audits: There are two goals here: First, the RCC must re-test at least one
representative customer site in each major city, customer center, or LCT area each
year, and second, the re-testing should show no significant inconsistencies with
earlier testing by the Assembler.
44 7 Performance Measurements and Quality Records

Illustration 4-1: Notice Of Noncompliance (NON) Letter Process Chart

46 7 Performance Measurements and Quality Records

© 2007 General Electric Company.
GE Medical Systems, a General Electric Company, going to market as GE Healthcare.
78530, Buc
FRANCE
HHS
Tools and Miscellaneous Test Procedures
46-017560
Revision 19
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.
46-017560 Revision 19 HHS i

Language Policy

работа.
опасност.
害。
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 prir-
učnik.
• Zanemarite li ovo upozorenje, može doći do ozljede davatelja usluge, operatera ili pacijenta us-
lijed strujnog udara, mehaničkih ili drugih rizika.

jeho obsah.
či jiných rizik.
ii HHS 46-017560 Revision 19

• Manglende overholdelse af denne advarsel kan medføre skade på grund af elektrisk stød, me-
kanisk eller anden fare for teknikeren, operatøren eller patienten.

gevaren.

(EN) • If a customer's service provider requires a language other than English, it is the customer's re-
sponsibility to provide translation services.
understood.


ohjeen.
46-017560 Revision 19 HHS iii

(FR) • Si le technicien d'un client a besoin de ce manuel dans une langue autre que l'anglais, il in-
combe au client de le faire traduire.

den zu haben.
kommen.

• Εάν δεν λάβετε υπόψη την προειδοποίηση αυτή, ενδέχεται να προκληθεί τραυματισμός στο
άτομο παροχής σέρβις, στο χειριστή ή στον ασθενή από ηλεκτροπληξία, μηχανικούς ή

nem értelmezték.

iv HHS 46-017560 Revision 19

い。

(KO) • 고객의 서비스 제공자가 영어 이외의 언어를 요구할 경우, 번역 서비스를 제공하는 것은 고
객의 책임입니다.
시오.

JUMS • Ja klienta apkopes sniedzējam nepieciešama informācija citā valodā, klienta pienākums ir no-
(LV) drošināt tulkojumu.

privalo klientas.
• Nemėginkite atlikti įrangos techninės priežiūros, jei neperskaitėte ar nesupratote šio eksploa-
tavimo vadovo.

oversettelse.
• Manglende hensyn til denne advarselen kan føre til at serviceleverandøren, operatøren eller pa-
sienten skades på grunn av elektrisk støt, mekaniske eller andre farer.
46-017560 Revision 19 HHS v

OSTRZEŻE- Niniejszy podręcznik serwisowy dostępny jest jedynie w języku angielskim.
NIE • Jeśli serwisant klienta wymaga języka innego niż angielski, zapewnienie usługi tłumaczenia jest
(PL) obowiązkiem klienta.
go.

(PT-BR) • Se outro serviço de assistência técnica solicitar a tradução deste manual, caberá ao cliente for-
necer os serviços de tradução.
tência técnica.
• A não observância deste aviso pode ocasionar ferimentos no técnico, operador ou paciente de-
correntes de choques elétricos, mecânicos ou outros.

(PT-PT) • Se qualquer outro serviço de assistência técnica solicitar este manual noutro idioma, é da re-
sponsabilidade do cliente fornecer os serviços de tradução.
tência técnica.

(RO) • Dacă un furnizor de servicii pentru clienţi necesită o altă limbă decât cea engleză, este de dato-
ria clientului să furnizeze o traducere.
service.
ОСТОРОЖН Данное руководство по техническому обслуживанию представлено только на английском

О! языке.
vi HHS 46-017560 Revision 19

UPOZOR- Ovo servisno uputstvo je dostupno samo na engleskom jeziku.
ENJE • Ako klijentov serviser zahteva neki drugi jezik, klijent je dužan da obezbedi prevodilačke usluge.
(SR) • Ne pokušavajte da opravite uređaj ako niste pročitali i razumeli ovo servisno uputstvo.

ATENCION Este manual de servicio sólo existe en inglés.

(ES) • Si el encargado de mantenimiento de un cliente necesita un idioma que no sea el inglés, el cli-
ente deberá encargarse de la traducción del manual.
de servicio.
• La no observancia del presente aviso puede dar lugar a que el proveedor de servicios, el opera-
dor o el paciente sufran lesiones provocadas por causas eléctricas, mecánicas o de otra natu-
raleza.

handboken.
• Om du inte tar hänsyn till den här varningen kan det resultera i skador på serviceteknikern, op-
eratören eller patienten till följd av elektriska stötar, mekaniska faror eller andra faror.

(SL) • Če ponudnik storitve stranke potrebuje priročnik v drugem jeziku, mora stranka zagotoviti pre-
vod.
• Če tega opozorila ne upoštevate, se lahko zaradi električnega udara, mehanskih ali drugih ne-
varnosti poškoduje ponudnik storitev, operater ali bolnik.
46-017560 Revision 19 HHS vii

(TR) • Eğer müşteri teknisyeni bu kılavuzu ingilizce dışında bir başka lisandan talep ederse, bunu ter-
cüme ettirmek müşteriye düşer.

viii HHS 46-017560 Revision 19

Revision History
1 Apr. 30, 1996 Added new Section 2–4 and Section 5. -
2 Dec. 1, 1997 Revised to include hardcopy form references for third party -
users.
3 July 15, 2003 Updated for INNOVA 4100 for M3a. -
4 April 23, 2004 Fluke87 multimeter added to list of tools in section 1, -

BUCge93442.
5 June 30, 2004 Section 1, step 2 updated, EURge13494 -
6 February 15, 2006 Added: Innova 3100–IQ and Innova 4100–IQ information -
Added: Innova 2100–IQ suitcase
7 July 20, 2007 Added: Innova 2121–IQ and Innova 3131–IQ information. -
8 Dec. 20, 2007 Converted from Interleaf into e-CLS Platform. 48
9 March 17, 2008 Chapter 2 section 1, Chapter 5 sections 1 and 2 (REG0093) up- 48
dated with new Victoreen tool
10 August 5, 2010 In Chapter 5, Radiation Instruments, in section “ Radiation 48

Measuring Instruments”, the following sections have been add-
ed:
• 1.5 Unfors Xi
• 1.6 RTI Piranha
• 1.7 Fluke TNT12000
• 1.8 Radcal Rapidose
• 1.9 Radcal Accu-Pro
Chapter 5, Radiation Instruments, updated with a new section

“4 KVp & HVL Measuring Instruments”
11 July 27, 2011 Updated to introduce Innova IGS 520, 530, 540 48
12 September 26, 2011 Updated to introduce Discovrey IGS 730 48
13 January 20, 2012 Updated to introduce Innova IGS 620, 630 48
14 May 29, 2012 Chapter 2, section “Introduction” has been updated to intro- 48
duce Optima CL320i/CL323i
15 August 20, 2013 Updated to introduce Discovery IGS 740 and change product 48
name to DiscoveryTM IGS 730, DiscoveryTM IGS 740
16 September 4, 2013 Updated to introduce Optima IGS320 48
46-017560 Revision 19 HHS ix

(continued)
17 September 4, 2014 Updated to change product name to “InnovaTM IGS 620” and 48
“InnovaTM IGS 630”
18 March 4, 2015 Updated to introduce “Optima IGS 330” and change product 48
name to “Optima IGS 320”
19 January 2021 Updated of Required Tools and REG0094 to simplify product 40

names and introduce "Allia™ IGS Systems"
x HHS 46-017560 Revision 19

Contents
Chapter 1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Chapter 2 Required Tools . . . . . . . . . . . . . . . . . . . . . . . . 3

2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.2 Test Equipment Requiring Calibration . . . . . . . . . . . . . . . . . . . 4
2.3 Calibration Services . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.4 Calibration and Repair Expense Accounting . . . . . . . . . . . . . . . . . 5
2.5 Shipment to Vendors . . . . . . . . . . . . . . . . . . . . . . . . 6
2.6 Return of Equipment to Headquarters for Calibration . . . . . . . . . . . . . . 6
2.7 Calibration Responsibility . . . . . . . . . . . . . . . . . . . . . . . 6
Chapter 3 Alternative Film Testing Procedures . . . . . . . . . . . . . . . . . 7

3.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.2 REG0089 - SID Test . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.2.1 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.2.2 Finalization . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.3 REG0090 - Bucky/Cass. Holder Test (Collimator rotation) . . . . . . . . . . . . . 8
3.3.1 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.3.2 Finalization . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.4 REG0091 - Bucky/Cass. Holder Test (no Collimator rotation) . . . . . . . . . . . . 9
3.4.1 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.4.2 Finalization . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.5 REG0092 - Light to X-Ray Field Test . . . . . . . . . . . . . . . . . . . . 10
3.5.1 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.5.2 Finalization . . . . . . . . . . . . . . . . . . . . . . . . . 11
Chapter 4 Mounting Focal Spot Decals . . . . . . . . . . . . . . . . . . . . 13

4.1 Mounting Focal Spot Decals . . . . . . . . . . . . . . . . . . . . . . 13
Chapter 5 Radiation Instruments . . . . . . . . . . . . . . . . . . . . . . 15

5.1 Radiation Measuring Instruments . . . . . . . . . . . . . . . . . . . . 15
5.2 REG0093 - Preliminary Set-up. . . . . . . . . . . . . . . . . . . . . . 17
5.2.1 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.2.2 Finalization . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.3 Probe Saturation Effects . . . . . . . . . . . . . . . . . . . . . . . 19
5.4 KVp & HVL Measuring Instruments . . . . . . . . . . . . . . . . . . . . 21
Chapter 6 Instructions for setting up the HHS data spreadsheet . . . . . . . . . . . 23
46-017560 Revision 19 HHS xi

6.1 REG0094 - Setting-up of the HHS Data Spreadsheet . . . . . . . . . . . . . . . 23
6.1.1 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 23
6.1.2 Finalization . . . . . . . . . . . . . . . . . . . . . . . . . 24
xii HHS 46-017560 Revision 19

Safety
Chapter 1 Safety
1.1 Safety
1.1.1 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.
If you have any comments, suggestions or corrections to the information in this document, please write
them down, include the document title and document number, and send them to:
46-017560 Revision 19 HHS 1

Safety

AMERICAS W–622
P.O. BOX 414
1.1.2 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.
1.1.3 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, WI (414) 827–3449 / 8*285–3449 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).
2 HHS 46-017560 Revision 19

Required Tools
Chapter 2 Required Tools
2.1 Introduction
The tools required for HHS Field Tests are listed below. Not all items will be required to check simple
systems. If in doubt, study each test to be performed.
NOTE
Tools must be properly calibrated and in good working order. Calibration data must be
recorded on data form which includes required GE calibration frequencies.
1. Field Laptop Computer with Excel spreadsheet versions of HHS Data Sheets. These are found in the XR
TOOLS window. Alternately, the sample forms in 46–017566, HHS FORMS, COMPLETING THE FDA 2579
AND GE DATA RECORD FORMS can be photocopied.
2. HHS Field Test Kit 46–303879G1, or old style kit, 46–177372G1 with upgrade 46–315614G1.
• (For Innova 2000 and Systems with 21 cm detector) use the 2280567 Lead Sheet suitcase.
• (For Systems with 31 cm detector) use the 2408517 HHS test kit.
• (For Systems with 41 cm detector) use the 2370573 HHS test kit)
3. Keithley 35080 HV Divider non-invasive (other kVpmeters (refer to Radiation Measuring Instruments,
section 4, KVp & HVL Measuring Instruments).
4. Radiation meter with rate and integrate modes (Refer to Chapter Radiation Instruments).
5. Victoreen 470A survey meter, or MDH meter with earphone, or Victoreen 451B (5270475) for vascular.
6. Mammo probe for rate meter.
7. mAs meter.
8. Light meter, Digaphot 3300/3303 or equivalent, must have an accuracy of 5% or better.
9. Fluke 87 series 3 multimeter.
10. Digital Voltmeter: Fluke 8030A or Beckman 3030 RMS or equivalent.
11. Film marking pencils or felt tip pens. The pencils are available from the supplies section (Cat. No.
E7005A for box of 12).
12. Additional instruments described in the individual service manuals for functional check.
13. Long Afterglow Phosphor tool, 2120565, for light to X–ray field alignment test and spot–film device X–
ray field size test.
NOTE
If the system fails the SID test of 46–017564 HHS COLLIMATOR TESTS, it may be necessary to
obtain a Focal Spot Locator Kit, 46–250080G1.

Required Tools
2.2 Test Equipment Requiring Calibration

Meters and instruments are to be calibrated per the schedule found in the on-line manual system (OLMS)
Page 105. Calibration status, (due, not due), for any piece of test equipment is found in the TRAC System (on-
line). Calibration can be more frequent if the situation requires, e.g., when a meter is damaged.
2.3 Calibration Services

All services described here must be traceable to the National Institute of Standards & Technology (NIST).
2.3.1 Calibration Service

Use the following calibration services for the indicated equipment:
1. The Manufacturers Factory Authorized Service Centers for all equipment except radiation meters by
Capintec (models 192 and 174) and MDH (2025).
2. Reputable local metrology labs and test equipment service vendors as determined by Region
management for all equipment except radiation meters by Capintec (models 192 and 174) and MDH
(2025).
NOTE
Radiation meter calibration must include calibration of the electrometer and calibrating
of all ion chamber probes. For X–Ray service applications, the ion chamber should be
calibrated at one point only. The optimum calibration point for X–Ray service use is 100
kVp/HVL 5 mm Al. A vendor may offer to furnish and charge an additional amount for ion
chamber calibration at more than one calibration point. Make sure that you are not
paying for unnecessary calibration at more than one point.
3. GE Instrumentation & Computer Services (GE-ICES) repairs and calibrates all types of instruments
except radiation meters by Capintec (models 192 and 174) and MDH (2025).
4. Capintec and MDH meter should be sent to GE Electronic Services in Kansas City, with one exception:
As of this writing, GEES cannot calibrate a mammo probe for the MDH meter. If your MDH meter has a
mammo probe, refer to the following step.
5. Radcal Corp. Division of MDH for MDH 2025 radiation meters with mammo probes.
2.3.2 National Contracts with Medical Systems

These contracts should be utilized by all Regions. If there are significant problems with a local contract
representative, contact Service Instrumentation Programs. Typical problems include: Lack of adequate
service responsiveness, billing issues and higher cost than local vendors (for the same services). A contract
will be updated to reflect the current contract conditions when they change.

Required Tools
2.4 Calibration and Repair Expense Accounting

The following accounts shall be utilized for charging of repair and calibration expenses for all service
instrumentation. Refer to the following table for the appropriate middle digits for these two account
numbers:
• 631-xx-xx Contract Maintenance
• 641-xx-xx Non-Contract/As Required Maintenance
Table 1 Accounts for repair and calibration expenses
Instrument Manufacturer Repair Service Mid Digits for 631 and

641
Oscilloscope Tektronix Tektronix Factory Centers 01
Oscilloscope Tektronix All other Service Shops 02
Oscilloscope Hewlett Packard HP Factory Centers 03
Oscilloscope Hewlett Packard All other Service Shops 04
Oscilloscope All GE-ICES 17
Digital Multimeter Fluke All 05
Digital Multimeter All other All 06
Digital Multimeter Beckman All 07
Leakage Meters Microguard All 08
Leakage Meters All others All 09
Radiation Meter Capintec All 10
Radiation Meter MDH All 11
Focaligner Mark II Lenox Industries All 12
Focaligner Mark V FJW Industries All 13
Line Monitor Dranetz All 14
Defibrillator Analyzer GMI All 15
Physiological Simulator Fogg All 16
All other Capitalized Serv- 00

ice Instrumentation

Required Tools
NOTE
All maintenance of expense tools and equipment should be charged to 632-00-xx.
It is important that the correct account numbers be utilized so that equipment calibration
and repair costs may be accumulated in order to measure equipment performance and for
blanket repair/calibration contract negotiation purposes.
2.5 Shipment to Vendors

When shipping test equipment to vendors for repair and calibration, use the following guidelines:
1. All shipments are to be on a purchase order; this assures return of the instruments.
2. Transportation to the vendor should be prepaid. The return freight will be prepaid by the vendor unless
specified otherwise on the purchase order.
3. Premium transportation charges are the district’s responsibility. Authorization for non-surface
transportation is necessary.
2.6 Return of Equipment to Headquarters for

Calibration
High Voltage Bleeders are the only instruments which should be returned to GEHC for calibration or repair.
This involves completing two forms:
1. An RGD form for return to the Parts and Repair Operation Service Shop, Waukesha, Wisconsin.
2. An RGD form for return of High Voltage Bleeders.
2.7 Calibration Responsibility

Each Regional Manager shall assign an employee in the Region to be responsible for:
• Insuring that a calibration program is maintained in accordance with this P&P Bulletin.
• Insuring that calibration records are maintained in the Region for all instruments covered by this P&P
Bulletin.

Alternative Film Testing Procedures
Chapter 3 Alternative Film Testing

Procedures
3.1 Introduction
In some cases these tests may be preferable to the procedures in 46–017564 HHS COLLIMATOR TESTS. An
example of this is the SID test in the case where the design of the tube assembly interferes with easy
measurement with a tape measure.
3.2 REG0089 - SID Test

Use this procedure if you cannot easily run a tape measure between the focal spot decal and the film plane,
or if there is a chance that the decal may be misplaced.
Table 2 Personnel requirements
Required persons Preliminary require- Procedure Finalization

ments
1 Not Applicable Not Applicable Not Applicable
3.2.1 Procedure
1. Select one of the HHS kit Plexiglas plates with the 1 cm pattern and slide the plate, pattern side up,
onto the collimator rails.
2. Select the desired SID, auto. mode, and insert a 12” x 14” loaded cassette into the Bucky.
3. Select AEC mode, 60 kV and expose the film. If AEC is not available select about 2 to 5 mAs.
4. The spacing of the pattern image is independent of location on the film or orientation of the tube axis.
Therefore simply make the measurement in the sharpest part of the image, (anode end). Mark the
centers of two crosses at the edge of the film, measure the separation, and divide by the number of
spaces to obtain the unit spacing (S).
5. Use the formula engraved on the pattern to calculate the SID. For an Ultranet S or SA collimator the
formula is:
SID = 29.85 x S’ where S’ = unit spacing of pattern on film.
3.2.2 Finalization
No finalization steps.

3.3 REG0090 - Bucky/Cass. Holder Test (Collimator

rotation)
If the collimator rotates on its axis it may be quicker to perform this test than the one in 46–017564 HHS
Collimator Tests.

ments
3.3.1 Procedure
1. Insert a loaded 14” x 17” cassette into the Bucky or cassette holder.
2. Select the desired SID, auto. mode, 60 kV, AEC mode and a low density. If AEC is not available select 60
kV and about 2 mAs for a 44” SID.
3. Rotate the collimator 45° on its axis and expose the film. Remove the cassette and temporarily set it
aside.
4. Insert a medium cassette and allow the collimator to size down. Now set the collimator to override.
This will allow you to change cassettes without having the collimator re-size itself.
5. Re-insert the original loaded cassette, and make a second exposure on the same film.
6. Remove the cassette and place the collimator in auto. mode.
7. Insert a small cassette and allow the collimator to size down. As before, set the collimator to override
and replace the small cassette with the original loaded large cassette.

8. Make a third exposure on the same piece of film. With a little practice you will be able to get three
readable images superimposed on one film as shown in the following illustration.
Figure 1 Superimposed images from sentry collimator
3.3.2 Finalization
3.4 REG0091 - Bucky/Cass. Holder Test (no Collimator

rotation)
For this alternative you will use the Plexiglas plate with the .10” grid pattern. We can’t think of a situation
when this procedure would be preferable to the one of 46–017564 HHS Collimator Tests. Perhaps you just
like doing this the hard way. The plate contains a .10” grid pattern. Films are exposed simultaneously in the
Bucky and in the cardboard cassette. The pattern on the two films is used to determine the magnification
ratio. Magnification is then used to determine the size of subsequent exposures using film in the cardboard
cassette and empty cassettes in the Bucky.

ments

3.4.1 Procedure
1. Insert a 10” x 12” loaded cassette into the Bucky, and slide the Plexiglas plate, onto the collimator rails.
2. Select the desired SID, auto. mode, 60 kV, and AEC mode. If AEC is not available select 60 kV and about
5 mAs for a 44” SID.
3. Load a 5” x 7” film into the cardboard cassette and attach this to the Plexiglas plate via the strip
magnets on each piece. If 5” x 7” film is not available, use the lead backed 10” x 12” vinyl cassette from
the HHS kit and attach this to the Plexiglas plate with tape or clips.
4. Expose the two films simultaneously and process them.
5. Determine the magnification by comparing the size of one large square on the Bucky film to one large
square on the collimator film.
NOTE
The magnification is not the pattern size on the Bucky film divided by the actual size of
the pattern (1.00”). Magnification is always determined by comparing two film images.
6. Insert small and large empty cassettes into the Bucky and expose additional collimator films. You may
be able to offset the collimator film to capture two exposures on one film.
7. Multiply the dimensions of the images on the collimator films by the magnification ratio to determine
the size of the X–ray field at the Bucky film plane.
3.4.2 Finalization
3.5 REG0092 - Light to X-Ray Field Test


ments
Table 6 Required conditions
Condition Reference Effectivity
The total misalignment of the X-Ray - -

and light fields in either the lateral or
longitudinal directions may not ex-
ceed 2%, (rejection limit is 1.8%).
10 HHS 46-017560 Revision 19

3.5.1 Procedure
1. Beam angulation is irrelevant, set for convenience. Use common SID.
2. Insert a 12” x 14” loaded cassette into the bucky or cassette holder and center it.
3. Select manual collimator mode. On some systems (e.g. remote tables) this may require first selecting
AUTO, then one on one format, and then going into override or OBL mode.
4. Place the light to X–ray test pattern on the table (or tape to wall unit).
5. Using the collimator dials, adjust the light field to a 10” square as indicated on the test pattern. Center
the pattern as necessary.
6. Select 60 kV and AEC mode; if no AEC use 2 to 5 mAs. Expose the film.
7. Refer to the following illustration. Following the instructions above, the light field readings should all be
5.00”. Determine the difference between X–ray and light fields by reading the X–ray field numbers
directly off the image using the scales printed on the image.
NOTE
The fact that the test pattern and cassette are not in contact has no bearing on this
measurement. Since the pattern is in inches, you can use the image of the scales to
measure the misalignment regardless of any magnification. You get the same relative
image if the cassette is in the table or under it. If coins or Allen wrenches were used for
this test, there may be some concern about magnification.
Figure 2 Light to X-Ray Field Test
3.5.2 Finalization
46-017560 Revision 19 HHS 11

12 HHS 46-017560 Revision 19

Mounting Focal Spot Decals
Chapter 4 Mounting Focal Spot Decals
4.1 Mounting Focal Spot Decals

Unless the actual location is marked, FDA inspectors’ checks of SID accuracy are based on an estimate of
focal spot location. Thus all exposed tube housings should have a decal located to show the focal spot
location. This decal not only improves FDA inspector’s accuracy, but also enables installers to check their
previous results. Refer to focal spot locater kit 46–250080G1 and Direction 46-017078. This kit consists of
three tools, one each for Maxiray 75, Maxiray 100, and Maxiray 125 tubes.
46-017560 Revision 19 HHS 13

Mounting Focal Spot Decals
14 HHS 46-017560 Revision 19

Radiation Instruments
Chapter 5 Radiation Instruments
5.1 Radiation Measuring Instruments

When making measurements, the accuracy of the instruments must be taken into consideration. The
calibration accuracy is usually listed on the meter and the probes. When making measurements, always
consider that the meter is reading low and, therefore, set up the equipment to a lower value to take into
account the maximum calibration error. For example:
The table top output is not to exceed 10 R/min as set with an instrument that has an accuracy of +/- 5%. The
meter accuracy for this reading would be 10 R/min +/- 0.5 R/min. Therefore, set the maximum table top
exposure rate to 9.5 R/min on the meter so that the actual table top exposure rate is 9.5 R/min +/- 0.5 R/min
and the maximum output will not exceed 10 R/min.
5.1.1 MDH Models 1015 and 2025/2026

These digital meters are equipped with two probes for measuring exposure rates and exposures from 0.001
R/hr to 1000 R/min and 0.01 mR to 200 R, full scale.
Application: Fluoro and Cine set up, Entrance exposure rates, Half-value layer measurements and
cadiographic exposures (Must NOT be used for leakage and scatter measurements).
Accuracy: + 5%, including probe energy dependency (above 50 kVp). Refer to Probe Saturation Effects.
In addition, the Model 2025/2026 is used with the Model 20X5–6M mammography probe for measuring
exposure rates and exposures from 0.001 R/min to 1000 R/min and 0.1 mR to 200 R, full scale.
Application: Reproducibility of exposure tests, Half–value layer measurements and Transmission
measurements for image receptor supporting devices.
Accuracy: +/– 5%, 10 keV to 40 keV.
5.1.2 Capintec Models 192A and 174

These digital meters are equipped with two probes for measuring radiation exposure rates and exposures
from 20 mR/min to 200 R/min and 20 mR to 2000 R, full scale. See Direction 46-013983. A third probe, for
surveys, measures to 2 mR/min full scale.
Application: Fluoro and Cine set up, Entrance exposure rates, Half-value layer measurements and
Radiographic exposures. (Must NOT be used for leakage and scatter measurements).
Accuracy: +/– 5%, including probe energy dependency (above 50 kVp). Refer to Probe Saturation Effects.
5.1.3 Victoreen Model 470A

This meter is equipped with one built–in probe used for measuring exposure rates from 3 mR/hr to 1000
R/hr, full-scale.
Application:Application: Leakage and scatter radiation measurements. (Must be used for Primary Barrier
Transmission Tests and for under–table tube leakage radiation tests.)
Accuracy: within +/- 10% of full–scale indication exclusive of energy response. Refer to Probe Saturation
Effects.
46-017560 Revision 19 HHS 15

5.1.4 Victoreen Model 451B

This meter is equipped with one built–in probe used for measuring exposure rates from 0.5 mR/hr to 5 R/hr,
full-scale.
Application: Leakage and scatter radiation measurements. (Must be used for Primary Barrier Transmission
Tests and for under–table tube leakage radiation tests.)
Accuracy: within + 10% of full–scale indication exclusive of energy response.
5.1.5 Unfors Xi
This digital meter is equipped with single solid state probe for measuring exposure rates and exposures from
140mR/min-7000R/min )(mode ”high”)and (70µR/min-7R/min)(mode ”low”); full scale. and exposures from
1mR-9999R )(mode ”high”)and (1µR-9999R)(mode ”low”); full scale.
Application: Fluoro and Record set up, Entrance exposure rates, Half-value layer measurements and
Accuracy: + 5%, including probe energy dependency (above 50 kVp)
5.1.6 RTI Piranha

This digital meter is equipped with R100B external solid state probe for measuring exposure rates and
exposures from : 0.11µR/s-520R/min; and exposures from 12nR-170kR full scale.
Accuracy: + 5%, including probe energy dependency (above 50 kVp). Refer to Section 3,Probe Saturation
Effects
5.1.7 Fluke TNT12000

This digital meter is equipped with two probes for measuring exposure rates from 100µR/s – 20R/s (15cc
chamber), 10µR/s – 2R/s (150 cc chamber); and exposures from 100µR - 20R (15cc chamber), 10µR – 2R (150
cc chamber), full scale.
Application: Fluoro and Record set up,, Entrance exposure rates, Half-value layer measurements and
Effects.
5.1.8 Radcal Rapidose

This digital meter is equipped with a solid state probe for measuring exposure rates and exposures from
0.68mR/min-0.82kR/min and exposures from11µR-1.1kR full scale.
Accuracy: + 5%, including probe energy dependency (above 50 kVp).
16 HHS 46-017560 Revision 19

5.1.9 Radcal Accu-Pro

This digital meter is equipped with two probes for measuring exposure rates from 1µR/s – 22R/s (6cc
chamber), 50nR/s – 0.6R/s (180 cc chamber) and exposures from 10µR - 79kR (6cc chamber), 200nR – 2.6kR
(180 cc chamber), full scale.
Application: Fluoro and Record set up,, Entrance exposure rates, Half-value layer measurements and
Effects.
5.2 REG0093 - Preliminary Set-up

There are five preliminary checks and setup procedures that must be followed prior to using a meter to
measure radiation.

ments
5.2.1 Procedure
1. Check to see that meter bears a calibration sticker and that calibration is not past due.
2. Connect up all cables and set probe in proper orientation for measurement.
3. On the meter:
a. Turn meter “ON”.
b. Check battery (where applicable).
c. Allow adequate warm-up, as specified by manufacturer.
d. Check zero. Adjust if necessary.
e. Check background or leakage (where applicable). Adjust if necessary.
4. Verify proper operation of the meter using the calibration check source (if supplied with meter).
5. Remove protective caps from chambers (where applicable).
NOTE
However, for the Victoreen Model 470 A meter, you MUST use the meter with the cap in
place on the front of the meter, AND with the disk shaped cover affixed to the end of the
meter cap.
46-017560 Revision 19 HHS 17

NOTE
However, for the Victoreen Model 451B meter, you MUST use the meter with the slide
open, to see the circular metallic entrance window of the survey meter chamber.
Otherwise low kV radiation will be strongly attenuated.
The meter is now ready to measure radiation. See 46–017563 HHS Fluoro System Tests for equipment
set-up.
Figure 3 Active Volume of Probe
18 HHS 46-017560 Revision 19

Figure 4 Active Volume of Probe
5.2.2 Finalization
5.3 Probe Saturation Effects

All probes have a limit on the intensity of radiation they can measure. A common convention is to place the
limit at the point where the probe’s ion collection efficiency drops to 95% of its normal value. When
measuring short radiation pulses, especially during beam quality tests, be careful that the peak field
intensity does not exceed the intensity limit of the probe.
NOTE
A radiation meter may give no indication of probe saturation other than an incorrect reading.
For single exposures measured on an integrating meter, the exposure rate is simply the R reading divided by
the exposure time.
Example: During beam quality tests, a 100 mR exposure is recorded; the exposure time is 20 ms. What is the
exposure rate?
Exposure rate = exposure ÷ exposure time
Exposure rate = 100 mR ÷ 20 ms = 5 R/s = 300 R/min
The exposure rate limits of some of the instruments we use are:
Table 8 Capintec
PR-16C probe (1.6 m) 84,000 R/min – (2% error)
PM-05 probe (5 ml) 30,000 R/min – (2% error)
46-017560 Revision 19 HHS 19

PM-30 probe (30 ml) 120 R/min – (2% error)
PM-500 probe (550 ml) 3 R/min – (2% error)
Table 9 MDH
3 ml probe 30,000 R/min, 500 R/s – (5% error)
180 ml probe 30 R/min, 0.5 R/s – (5% error)
6 ml mammo probe 1000 R/min, 16.7 R/s – (5% error)
Note that for the example, the Capintec 500 ml and 30 ml probes and the MDH 180 ml probe are all
inadequate and will provide incorrect (low) readings. Whenever the intensity limit of a probe is exceeded,
the probe will read low.
For repeated pulse exposures made on an integrating meter, the peak exposure rate is the R reading divided
by the product of the number of exposures and the pulse width, i.e.:
Peak exposure rate = R ÷ (no. of exp. x pulse width)
For repeated pulse exposures made on an exposure rate meter, the peak exposure rate is the rate meter
reading divided by the X-ray duty cycle (where duty cycle is pulse width x frame rate), i.e.:
Peak exposure rate = R/min ÷ (pulse width x frame rate)
Maintenance of Radiation Instruments
NOTICE
Avoid condensation on radiation meters.

Meters subjected to condensation may require hours (in some cases days) to
dry out and stabilize. If a meter will be exposed to extreme cold, store the
meter, probes, and cables in air-tight plastic bags and don’t open the bags
unless the contents are at room temperature. Failure to observe this caution
could result in excessively noisy or inaccurate readings.
Radiation measuring instruments must be calibrated:
1. At intervals indicated on calibration sticker.
2. After repair of instrument (except change of batteries).
3. After operation where meter is found to malfunction.
4. If there is any suspicion that the instrument may have been dropped or been subjected to other abuse.
The instruments must be returned to the manufacturer for calibration. In addition, any repair of radiation
instruments must be done through the manufacturer, since the instruments must be re-calibrated after
repair.
Radiation meters must carry a calibration sticker, indicating the dates of the last and next recalibration.
20 HHS 46-017560 Revision 19

5.4 KVp & HVL Measuring Instruments

5.4.1 Unfors Xi
This digital meter is equipped with single solid state probe for kVp, kV , HVL:
• Range: 35kV to 160kV
• Filtration correction range:from 2.5mm Al filtration to 1mm Cu or equivalent. Active compensation.
• HVL range:1.0 to 14mm Al : Accuracy ±0.2mm Al or 10%
Application: Fluoro and Record set up, Reproducibility, Accuracy of kVp, Half–value layer measurements
Accuracy: + 2%.
5.4.2 RTI Pirahna

This digital meter is equipped with internal solid state probe for kVp, kV , HV:
• Reproducibility: ±1%
• Filtration correction range: 1mm Al to 10mm Al.
• HVL range:1.2 to 10mm Al : Accuracy ±0.2mm Al or ±10%
Application: Fluoro and Record set up , Reproducibility , Accuracy of kVp, Half–value layer measurements
Accuracy: + 2%.
5.4.3 Fluke TNT12000

This digital meter is equipped with internal solid state probe for kVp, kV , HVL:
• Filtration correction range:from 2.5mm Al filtration to 1mm Cu or equivalent. Active compensation.
• HVL range:1.0 to 14mm Al : Accuracy ±0.2mm Al or 10%
Accuracy: + 2%.
5.4.4 Radcal Rapidose

This digital meter is equipped with internal solid state probe for kVp, kV , HVL.:
• Filtration correction range: 2mm Al to 22mm Al.
• HVL range:1.3 to 10mm Al : Accuracy ±0.5mm Al or ±10%
• Total Filtration range:2 to 22mm Al : Accuracy ±0.5mm Al or ±10%
46-017560 Revision 19 HHS 21

Accuracy:+ 2%. or ±1.5kV
5.4.5 Radcal Accu-Pro

- This digital meter is equipped with with 40x12 w Accu kV sensor for kVp, kV , HVL:
• Reproducibility: ±0.2kV
• Filtration correction range: 1mm Al to 23mm Al
• HVL range:1 to 23mm Al : Accuracy ±0.3mm Al or ±1
Accuracy:±1% or ±1kV
22 HHS 46-017560 Revision 19

Instructions for setting up the HHS data spreadsheet
Chapter 6 Instructions for setting up the HHS

data spreadsheet
6.1 REG0094 - Setting-up of the HHS Data

Spreadsheet
Excel 5 spreadsheets replace the traditional hard copy HHS data records. Spreadsheets are available for
form 3382 (basic xr, vas., and parts replacement), 3382MM (mammo.) and 3382IN for the Innova Systems,
the Discovery™ IGS Systems, Allia™ IGS Systems and Optima Systems. For X-Ray tube or other certified part
replacements, use spreadsheet 3382. Spreadsheets are in the XRTOOLS window, along with a README file
which contains these instructions.

ments
6.1.1 Procedure
1. Double click XRTOOLS window.
2. Double click desired spreadsheet. If using 3382, open and print README file; it contains a convenient
test pattern for use in performing overhead collimator light and X–Ray field tests.
3. After reading Intro sheet of the spreadsheet and familiarizing yourself with the Help sheet, click on
data entry sheet (click on the tab at bottom of screen that says data entry).
4. Click Start button near top of data entry sheet and follow screen instructions for entering basic
customer information. Use Tab key to skip over non–data cells. Be sure to click done button after
entering basic customer information (this action creates new customer file).
5. Follow screen instructions and enter test equipment information. When finished, click Room
Equipment button below test equipment chart.
6. Select room equipment, using any character to select. Never use backspace key to erase a wrong entry,
– use delete key or backspace and enter keys. Be sure to click done button after selecting all room
equipment. If this is not done then proper mA/kV accuracy chart will not be set up.
7. When room equipment has been indicated and associated done button is clicked, program will flag
appropriate tests. User will be presented with an index sheet from where he/she can select each
required test.
8. Fill in test data for each test that has a req. flag.
9. Save your work often by clicking Save Customer File which is found in main menu item Cookie Jar.
46-017560 Revision 19 HHS 23

Instructions for setting up the HHS data spreadsheet
10. When finished with all tests you should e-mail your data to your Zone Compliance Engineer. Select
UPLOAD DATA from main menu item Cookie Jar. Follow screen instructions. Macro routine will create
a small text file with data which can be attached to e-mail.
11. If a printout is desired, you may use print options in cookie jar, or you may print an individual test by
using Print button found near the top of each test section.
NOTE
Pass/fail flags will appear for each test when required data has been entered. For some
tests, a yes/no or n/a selection MUST be made in order to set p/f flag.
Some cells contain default values, such as 60 kV in the technique accuracy charts. Note
that the “kV” part of the entry is actually part of the cell format. To change the default
value, simple type in a new number, e.g. 70, without the “kV”. Similar examples of unit
formats are found throughout spreadsheets. You should always type only the number to
change default value.
To change default mA stations follow screen instructions. Refer to Help sheet if
necessary.
6.1.2 Finalization
24 HHS 46-017560 Revision 19

Buc 78530 FRANCE
HHS
HHS
Control and Tube Assembly Tests
46-017561
Revision 33
US English
WARNING
devices be used.
Language Policy

работа.
опасност.
害。
46-017561 Revision 33 HHS 3/52


priručnik.
jeho obsah.
či jiných rizik.
gevaren.
understood.
ohjeen.
4/52 HHS 46-017561 Revision 33


den zu haben.
kommen.
nem értelmezték.
い。
46-017561 Revision 33 HHS 5/52


시오.
privalo klientas.
vimo vadovo.
oversettelse.
go.
tência técnica.
tência técnica.
6/52 HHS 46-017561 Revision 33


service.
! языке.
de servicio.
naturaleza.
handboken.
prevod.
46-017561 Revision 33 HHS 7/52


Revision History
1 Apr. 30, 1996 Multiple changes to bring test procedures up-to-date. -
2 Dec. 1, 1997 Added reference to Keithley Non-invasive Voltage Divider use -
in AMX–4 Series (Section 3).
3 Nov. 24, 2000 Added Manual mA accuracy – for INNOVA 2000 only (New -
Section 4).
4 Nov. 5, 2001 Added modifications in Manual mA accuracy – for INNOVA -
2000 only (New Section 4).
5 March 14, 2003 Updated for Innova 4100 for ME2. SPR BUge86469 -
6 July 24, 2003 Updated for M3a. SPR BUge87092 and 89570. Added modifi- -
cations in Chapter 5 – Manual mA accuracy - for INNOVA
4100 (In Cardiac on Large Focal Spot, the step 13 table of
the procedure has been updated and the steps 22 to 25 has
been added.) In Section 5, ±15% replaces ±20%. Addition of
“TECHNICAL ACCURACY – kV for INNOVA 4100” section. SPR
BUCge94810
7 August 14, 2003 Updated for M3a. SPR BUge96138 -
8 October 17, 2003 Updated for M3b. SPR BUge93442 -
9 April 23, 2004 Section 5, mA Accuracy updated, BUCge93442 -
10 June 30, 2004 Section 6, step 3 updated, EURge12233 -
11 Jan 19, 2005 Section 5, and 6, title modified to include Innova 3100, -
EURge20430
12 Mar 18, 2005 Section 1, 5, and 6, title modified to include Innova 2100–IQ, -
EURge23969
13 February 15, 2006 Updated for Innova 2100/2100–IQ, Innova 3100/3100–IQ and -
Innova 4100/4100–IQ
14 June 5, 2006 CFR 1020.30/31/32 regulatory compliance. -
15 July 20, 2007 Added: Innova 2121–IQ and Innova 3131–IQ information, -
EURge48215, EURge66413. Section 2–3, step 2 has been up-
dated Section 2–3 updated per EURge73953 Sections 6 and 7
updated per EURge75794, EURge76403 and EURge77294.
16 Dec. 20, 2007 Conversion from Interleaf into e-CLS Platform 62
8/52 HHS 46-017561 Revision 33


17 May 4, 2010 Update of REG0052, REG0056, REG0057 and REG0058 66
18 August 5, 2010 New update of REG0052, REG0056, REG0057 and REG0058 62
19 January 26, 2011 New update of REG0058 62
20 July 27, 2011 Update of REG0052, REG0056, REG0057, which introduces In- 62
nova IGS 520, 530, 540.
21 September 23, 2011 Update of REG0052, REG0056, REG0057 to introduce Discov- 64
ery IGS 730
22 January 20, 2012 Update of REG0052, REG0056, REG0057 to introduce Innova 64
IGS 620, 630
23 January 27, 2012 Update of REG0052, REG0056, REG0057, REG0058 for Discov- 64
ery IGS 730
24 May 29, 2012 Update of REG0052, REG0056, REG0057 and REG0058 64
25 August 20, 2013 Update of REG0052, REG0056 and REG0057 to introduce Dis- 64
covery IGS 740 and change product name to DiscoveryTM IGS
730, DiscoveryTM IGS 740
Update of REG0056 and REG0057 for Jedi tool cover p/n.
26 September 4, 2013 Update of REG0052, REG0057 and REG0058 to introduce Opti- 64
ma IGS320. Also in REG0057, new P/N have been added.
27 September 4, 2014 Update of REG0052, REG0056 and REG0057 to change product 62
name to “InnovaTM IGS 620” and “InnovaTM IGS 630”.
28 March 4, 2015 Update of REG0052 and REG0057 to introduce “Optima IGS 62
330” and change product name to “Optima IGS 320”.
29 June 30, 2015 Update of REG0057 to introduce tool p/n 5507803 for Optima 62
IGS systems.
30 July 5, 2017 Update of REG0052, REG0056 and REG0057 to introduce “In- 64
novaTM IGS 5”, “InnovaTM IGS 6”, “DiscoveryTM IGS 7” and “Dis-
coveryTM IGS 7 OR”.
31 October 15, 2019 Update of REG0056 and REG0057. 62
32 January 2021 Updated of REG0052, REG0056, REG0057 and REG0058 to to 62
introduce "Allia™ IGS 7", "Allia™ IGS 7 OR", "Allia™ IGS Systems"
and "Optima IGS Plus"
33 November 2021 Update of REG0052, REG0056, REG0057 and REG0058 to in- 52
troduce "Allia™ IGS 3" and "Allia™ IGS 5".
46-017561 Revision 33 HHS 9/52

Control and Tube Assembly Tests Contents
Contents
1 HHS Control and Tube Assembly Tests ...........................................................................................13
1.1 Safety ............................................................................................................................................................................................. 13
1.2 Introduction................................................................................................................................................................................. 14
1.3 REG0052 - Generator Operator Indicators.................................................................................................................... 15
1.4 REG0054 - Technique Accuracy - Generator Timer ................................................................................................... 18
1.5 REG0053 - Technique Accuracy - kV/mA ........................................................................................................................ 18
1.6 REG0055 - Manual mA Accuracy (Innova 2000 only) ................................................................................................ 20
1.7 REG0056 - Tech & Manual mA Accuracy - Tool 2389357 ........................................................................................ 23
1.8 REG0057 - Tech & Manual mA Accuracy - Tool 2389357-2 or 5480040 or 5507803 ................................. 31
1.9 REG0058 - Technique Accuracy - kV (20, 30 and 40 cm Detector)...................................................................... 40
1.10 REG0059 - Technique Accuracy - mAs.......................................................................................................................... 43
1.11 REG0060 - Indirect Linearity ............................................................................................................................................. 44
1.12 REG0061 - AEC Maximum mAs........................................................................................................................................ 45
1.13 REG0062 - AEC Minimum Exposure Time.................................................................................................................... 45
1.14 REG0063 - Reproducibility Of Exposure....................................................................................................................... 46
1.15 REG0064 - Direct Linearity Of Exposure Alternate Method ................................................................................ 48
46-017561 Revision 33 HHS 11/52

1
1 HHS Control and Tube Assembly Tests
1.1 Safety
X-Ray Protection
WARNING

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.
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
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.
If you have any comments, suggestions or corrections to the information in this document, please
write them down, include the document title and document number, and send them to:
AMERICAS W–622
P.O. BOX 414
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
46-017561 Revision 33 HHS 13/52

1.2 Introduction Control and Tube Assembly Tests
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.
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, WI (414) 827–3449 / 8*285–3449 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 Introduction
The tests in this section require making exposures and recording data. Review all the tests of this
section at this time and plan an efficient test program to suit equipment.
Figure 1-1
14/52 HHS 46-017561 Revision 33

Control and Tube Assembly Tests 1.3 REG0052 - Generator Operator Indicators
1.3 REG0052 - Generator Operator Indicators

Table 1-1 Personnel requirements
1
HHS Control and Tube Assembly Tests

ments
1 Not Applicable 40 minutes Not Applicable
Table 1-2 Required conditions

When two or more X–Ray tubes - Innova IGS 620 and Innova IGS 630
are controlled by the same expo- or Innova IGS 6
sure switch (hand or foot), indicator
lamps shall be mounted on the tube
units to indicate the selection.
For X-Ray controls that incorporate - -
automatic exposure control: The
product of X-Ray tube current and
exposure time shall not exceed 600
mAs per exposure for tube potential
equal to or greater than 50 kVp.
This product shall not exceed 2000
mAs per exposure for tube potential
less than 50 kVp.In the event that
an exposure is terminated by the
600 mAs/2000 mAs backup, manual
reset is required before further au-
tomatically timed exposures can be
made. Visual indication is required
that the 600 mAs/2000 mAs backup
has been actuated.
Audible tones are required for: - -
Radiographic exposure termination,
Fluoro 5 minute timer termination.
X-Ray warning label shall be present. - -
Application
All X-Ray controls at installation and preventive maintenance calls, or when replacing major
components.
Discovery™ IGS 730, Discovery™ IGS 740 systems or Discovery™ IGS 7, Discovery™ IGS 7 OR systems
are also named Discovery™ IGS Systems. The procedure is applicable indifferently to Discovery™ IGS
730 orDiscovery™ 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.
Procedure
1. (Not applicable to Discovery™ IGS Systems and Allia™ IGS 7 and Allia™ IGS 7 OR Systems)
Check to see that indicator lights are mounted and functional on any tube units where the
same exposure switch actuates either tube (example: RAD 1 and RAD 2 both controlled from
handswitch). Most certified tube units are supplied with lamps. However, if additional indicator
lamps are needed, order kit 46-172124G1 from PRO. This is an important check since this is the
only way extra indicator lamps are recognized and procured.
46-017561 Revision 33 HHS 15/52

1.3 REG0052 - Generator Operator Indicators Control and Tube Assembly Tests
2. X–Ray Timer for systems delivered before June 2006:

Fluoro Timer: Set to 1 minute and allow to run out with beam blocked. There should be an
audible indication at about 30 seconds remaining time. Depending on control type, the exposure
may or may not terminate when the time runs down. If the exposure is not terminated by the
run out of the timer, there must be a device which keeps track of the cumulative exposure time.
If some of the controls have been placed on a remote panel, be sure that the audible indicator is
active at this panel.
3. X–Ray Timer for Innova 2100-IQ, Innova 3100/3100-Q, Innova 4100/4100-IQ systems, Innova IGS
520, 530, 540, Innova IGS 5, Allia™ IGS 3, Allia™ IGS 5, 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 and Optima IGS 330:
a. The cumulated elapsed time of Fluoro and Record X–Ray exposure sequences are counted,
and the operator is warned upon five minutes of cumulated time:
i. Run a fluoro without releasing the pedal until it automatically stops.
ii. (For Innova single plane, Optima and Discovery™ IGS Systems) Check that the audible
and visual warnings raise in control/exam rooms (i.e. on VCIM and TSSC) after 5
minutes +0/–15 secondes.
iii. (For Allia™ IGS Systems and Allia™ IGS 3) Check that the audible and visual warnings
raise in control/exam rooms (i.e. on VCIM and Touch Panel) after 5 minutes +0/–15
secondes.
b. The continuous Fluoro exposure sequence is automatically stopped upon ten minutes of
elapsed time.
i. Continue the fluoro pressing of the pedal until the fluoro automatically stops.
ii. Check that the fluoro warning is always activated during this period and that the fluoro
timer cut –off the X–ray after a continuous fluoro of 10 minutes +0/–30 secondes
iii. Depress and press again the fluoro pedal. Check that the fluoro starts again.
iv. Reset X-Ray timer for clearing warnings.
4. NOTE
Start the time measurement when image is displayed on monitor for both cases.
X–Ray Timer for Innova 2121-IQ and Innova 3131-IQ systems, Innova™ IGS 620 and Innova™ IGS
630, Innova™ IGS 6:
a. To test the cumulated X–Ray Timer Frt/Lat:
i. Open a new Exam. Click on the X–ray–Timer icon on the monitoring bar on the top of
the console. A pop-up window is opened displaying the Frt and Lat cumulated timers.
Verify Frt and Lat cumulated timers start at 0.0.
ii. Perform several Frt/Lat/Bp acquisitions until the Frt cumulated timer reaches the
warning limit of 5 min. Verify that (a) the X–ray–Timer icon and both Timer reset
buttons on (b) the VCIM and (c) the TSSC start blinking yellow. Verify a sound is audible
from the VCIM and TSSC master. Verify X–rays are not aborted or inhibited.
iii. Press the Timer reset button (VCIM or TSSC). Verify that in the pop-up window the Frt
timer is reset to 0.0 but the Lat timer is not.
iv. Perform several Lat/Bp acquisitions until the Lat cumulated timer reaches the warning
limit of 5 min. Verify that (a) the X–ray–Timer icon and both Timer reset buttons on (b)
the VCIM and (c) the TSSC start blinking yellow. Verify a sound is audible from the VCIM
and TSSC master. Verify X–rays are not aborted or inhibited.
v. Press the Timer reset button (VCIM or TSSC). Verify that in the pop-up window the Lat
timer is reset to 0.0 but the Frt timer is not.
16/52 HHS 46-017561 Revision 33
Control and Tube Assembly Tests 1.3 REG0052 - Generator Operator Indicators
b. To test the continuous X–ray Timer Frt/Lat:

i. Perform a continuous Frontal Fluoro acquisition for 10.0 min without interruptions and
measure the time with a stopwatch until the X–rays are aborted.
ii. Without interrupting the acquisition, verify that after 5.0 min the icon on the top of 1
the console and Timer reset buttons on VCIM and TSSC start blinking. Verify the Timer
warning tone is audible.

iii. Verify after 10.0 min (tolerance +0/–5%) the X–rays are aborted, but can be started
again if pedal is released and pressed again.
iv. Press the X–ray Timer reset button and verify that the timers in the pop-up window are
reset to 0.0.
v. Repeat the above test for a 10 min continuous Lateral Fluoro acquisition and 10 min
continuous Biplane Fluoro acquisition.
5. NOTE
Start the time measurement when image is displayed on monitor for both cases.
Verification of automatic exposure control reset and visual indication functions upon activation
of the 600 mAs/2000 mAs backup:
a. For Advantx Systems:
The reset and visual indication functions upon activation of the 600 mAs/2000 mAs backup
do not have to befield tested on Advantx systems.
By software design, these functions in applications mode are assured by successful
performance of the Calibration Tool Unit T005 “MAS Integrator Test” in calibration mode.
This Tool Unit T005 is performed in the procedure for maximum mAs for Advantx systems in
Section 6 of this Direction.
See the Advantx operational documentation for information on the operation of the
automatic exposure control reset function.
b. For Non-Advantx Systems: the test procedure for the reset and visual indication functions
is covered in the Functional Check chapter of the appropriate generator or automatic
exposure control service manual.
i. Check for proper operation of the audible tones or buzzers as required by regulations:
• Radiographic exposure: Make an exposure (no film needed).
• Make a fluoro recording (VTR, Cine, or Photo-spot). Film is not necessary.
ii. Verify the presence of warning label bearing the statement “WARNING: This X–ray unit
may be dangerous to patient and operator unless safe exposure factors and operating
instructions are observed” on the main X–ray control panel.
iii. For Systems manufactured On or After June 10th, 2006:
Verify the presence of a warning label bearing the statement on the main X–ray
control panel. WARNING: This X–Ray unit may be dangerous to patient and
operator, unless safe exposure factors, operating instructions and maintenance
schedules are observed. To be used by authorized personnel only.
6. Record Data
Record the data (apply any corrective factor if required and check final results are within
acceptance criteria).
Finalization
46-017561 Revision 33 HHS 17/52

1.4 REG0054 - Technique Accuracy - Generator Timer Control and Tube Assembly Tests
1.4 REG0054 - Technique Accuracy - Generator Timer


ments

When the equipment is connected - -
to an adequate power supply as
specified, the maximum deviation of
the exposure time from the selected
time shall not exceed the limits given
in the specifications (equipment op-
erating manual).
Application
All X-Ray units, (except those having only mAs selection capability, for such units, refer to REG0053
- Technique Accuracy - kV/mA on page 18), at installation, periodic maintenance calls, and when
repairing timer.
Procedure
1. This test is performed at the same time as the kV/mA accuracy test, refer to REG0053 -
Technique Accuracy - kV/mA on page 18.
2. Record data on Form F3382.
Figure 1-2 kV/mA Accuracy Chart
Finalization
1.5 REG0053 - Technique Accuracy - kV/mA


ments
Application
kVp and mA accuracy: At installation, periodic maintenance, and repair.
18/52 HHS 46-017561 Revision 33

Control and Tube Assembly Tests 1.5 REG0053 - Technique Accuracy - kV/mA
kVp and mA accuracy applies to all tubes in system.
Requirements
NOTE
1
Specified accuracy refers to technic accuracy statements made in the Product
Specification section of generator operating manuals.

1. kVp Accuracy – Actual kVp shall match selected kVp within the “specified accuracy”.
2. mA Accuracy – Actual mA shall match selected mA within the “specified accuracy”.
Each connected tube and generator forms a distinct X-Ray system. The tube usually limits the
range and combination of technic factors. Thus, accuracy of kVp and mA selections applies
only within ratings of the tube and focal spot used, even though selections beyond tube
ratings are available at the control.
mA and kVp limits for tubes are shown by curves on radiographic rating charts. The charts
have curves of mA or kW values. Selected mA must never exceed the largest mA value
shown. For kVp, the selection must never be less than the lowest kVp on the mA curve,
whether it ends at the bottom of the kVp scale or at a definite point above. This minimum
kVp limit is necessary for practical space charge compensation to meet accuracy requirements
and to preserve filament life. For maximum kVp, tube protector circuits are set to limit kVp
approximately where the mA curve crosses the selected time value.
Set up HHS data spreadsheet on laptop computer per 46–017560, HHS TOOLS.
Procedure
1. Be sure that generator panel meter accuracy has been verified. Refer to service manual for
procedure. Measure and record line voltage into generator.
2. Use non-invasive divider (refer to Figure 1-3 Detector Positioning for kVp
Measurement on page 19, Figure 1-4 Detector Positioning (vertical) for kVp
Measurement on page 20 and Figure 1-5 Divider Positioning for kVp Measurement (for under-
table tube) on page 20). Turn unit on and select tube to be checked, leaving both energized
continuously. Wait 1 hour and 15 minutes before making measurements.
Figure 1-3 Detector Positioning for kVp Measurement
46-017561 Revision 33 HHS 19/52

1.6 REG0055 - Manual mA Accuracy (Innova 2000 only) Control and Tube Assembly Tests
Figure 1-4 Detector Positioning (vertical) for kVp Measurement
Figure 1-5 Divider Positioning for kVp Measurement (for under-table tube)
NOTE
The following applies:
AMX-4 Series mobile X-Ray units require that a Keithley Non-Invasive kVp Divider
(Model 35080A with Deviation 535 or Model 35080B, both using Mobile Filter
Pack Plus 37946C and optional Low Range Filter Pack38237C) be used. No other
substitutions for non-invasive kVp Dividers are approved.
After several hours of no exposures, the first exposures should not be made at full
ratings.
3. Enter data required by technique accuracy charts on Form 3382 on laptop computer.
Recalibrate, if necessary, to obtain satisfactory performance.
Finalization
1.6 REG0055 - Manual mA Accuracy (Innova 2000 only)


ments
20/52 HHS 46-017561 Revision 33

Control and Tube Assembly Tests 1.6 REG0055 - Manual mA Accuracy (Innova 2000 only)
Application
mA accuracy: at installation, periodic maintenance, and repair.
mA accuracy applies to all tubes in system.
The tests described in this evaluation plan verify the accuracy of the mA in manual mode by 1
comparing the mA values entered manually into the system to the mA value measured by the VAMP

generator through its internal mAs meter.
Scope
Test accuracy between mA command and mA measured by the VAMP mAs–meter for various kV,
PW, fps, focalspot and acquisition modes.
Procedure
NOTE
Configure the system to perform manual acquisitions.
1. Select the X-220-Fluoro running at 30 fps.
2. Enter the value for kV, pulse–width and mA according to the table below in the range allowed by
the system and enter these values into the system.
NOTE
At low mA feedback, a part of the inaccuracy comes from the quantization step
(0.025) on this signal.
3. Perform a fluoro acquisition with these values for approximately 20 seconds.
4. Read the VAMP average mA feedback displayed on Titan Console just before the end of the
Fluoro acquisition.
5. Log in the table below this VAMP value and the technics feedback displayed in the status bar of
the SUIF. Compare the mA demand values to the corresponding mA feedback. The result of this
test is OK when the % difference is within the range (–20%, +20%).
Table 1-7
fps kVp mAs (mA) PW Average mA demand Average mA feedback % difference

30 65 0.025 (5) 5 0.75 (*)
30 70 0.05 (10) 5 1.5
30 75 0.15 (30) 5 4.5
30 80 0.375 (30) 12.5 11.25
30 100 0.375 (30) 12.5 11.25
30 120 0.41625 (33.3) 12.5 12.4875
NOTE
The real demanded values to the generator are those updated in the status bar about
is after the acquisition has started.
(*) This point is known to be close to the limits when tube is cold, repeat the point if
needed.
6. Select the X-220-Cardiac running at 30 fps.
7. Select the 0.6 FS and enter the values for kV, pulse–width and mA according to the table below
in the range allowed by the system and enter these values into the system.
8. Perform a cardiac acquisition with these values for approximately 10 seconds.
46-017561 Revision 33 HHS 21/52

1.6 REG0055 - Manual mA Accuracy (Innova 2000 only) Control and Tube Assembly Tests
Cardiac acquisition.
10. Log in the table below the VAMP value and the technics feedback displayed on the status bar of
test is Ok when the % difference is within the range (–20%, +20%).
Table 1-8

30 70 0.2 (40) 5 6
30 75 0.4 (80) 5 12
30 80 1.25 (250) 5 37.5 (*)
30 100 2.4 (240) 10 72
30 120 2 (200) 10 60
NOTE
(*) This point is known to be close to the upper limit on a very hot tube. Repeat the
point if needed on a cooler state of the tube (but not cold).
11. Select the X-220-Cardiac running at 30 fps.
12. Select the 1.2 FS and enter the values for kV, pulse–width and mA according to the table below
in the range allowed by the system and enter these values into the system.
13. Perform a cardiac acquisition with these values for approximately 10 seconds.
Cardiac acquisition.
15. Log in the table below the VAMP value and the technics feedback displayed on the status bar of
test is Ok when the % difference is within the range (–20%, +20%).
Table 1-9

30 80 1.25 (250) 5 37.5
30 80 2 (400) 5 60
30 90 7 (700) 10 210
30 100 6.4 (640) 10 192
30 120 5.33 (533) 10 159.9
NOTE
The real demanded values to the generator are those updated in the status bar about
is after the acquisition has started.
Finalization
22/52 HHS 46-017561 Revision 33

Control and Tube Assembly Tests 1.7 REG0056 - Tech & Manual mA Accuracy - Tool 2389357
1.7 REG0056 - Tech & Manual mA Accuracy - Tool

2389357 1

ments
Table 1-11 Tools and test equipment
Item Quantity Effectivity Part number Manufacturer

Detector Lead Block- 1 - 2337600 -
er
JEDI mA shunt meas- 1 - 2389357 -
urement external
tool
JEDI tool cover 1 All systems 2404211 -
JEDI tool cover 1 Innova single plane, 2404211-20 -
Discovery™ IGS sys-
tems and Allia™ IGS
Systems and Allia™
IGS 3
Standard Field Engi- 1 - - -
neering Tools with
metric and US
wrenches
Fluke 87 serie 3 mul- 1 - - -
timeter
Table 1-12 Safety
WARNING
RESIDUAL VOLTAGE PRESENT.

BEFORE SERVICING THE CABINET, AFTER HAVING POWERED IT OFF, ENSURE THAT
JEDI HAS NO RESIDUAL VOLTAGE.

The X-Ray tube mA _ Average com- - -
puted value with applied correction
(mA_Average correction 24 m or
mA_Average correction 28.70 m or
mA_Average correction 30 m) should
be within ± 20% of the mA_Average
Demand value.
The actual mA_average value updat- - -
ed at exposure end, available in the
X220 status bar, should be within ±
20% of the mA_Average Demand val-
ue.
46-017561 Revision 33 HHS 23/52

1.7 REG0056 - Tech & Manual mA Accuracy - Tool 2389357 Control and Tube Assembly Tests
Application
This procedure is applicable 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.
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.
This test plan will be performed in all following cases:
• System installation
NOTE
It is not required during System installation if the JEDI, the Ingrid and the X-Ray tube
are paired.
(For Innova IGS 5, Discovery IGS 7 Systems) Refer to IST0106 - X-Ray Tube Installation
or (For X-Ray Tube with Tube Holder) IST0507 - X-Ray Tube Installation.
(For Allia™ IGS Systems and Allia™ IGS 3) Refer to IST0507 - X-Ray Tube Installation.
(For Innova IGS 6) Refer to IST0169 - Lateral X-Ray Tube Installation and IST0171 -
Frontal X-Ray Tube Installation.
• System repair
Purpose
The tests described (see Table 1-14 Test Angio Parameters on page 29 and Table 1-15 Test Cardiac
Parameters on page 29) in this evaluation plan verify the accuracy of the X–Ray tube mA_Average
in all following system acquisition modes for kV_MIN and kV_MAX at mA peak tube current equal to
20% of the highest tube current.
• Angio mode (on Compressed, Small and Large focus)
• Cardiac mode (on Small and Large focus)
NOTE
The FLUORO acquisition mode is not performed because it is the same as Cardiac on
Small focus
The X–Ray tube mA _ Average is measured with an external tool and a multimeter in
manual mode using the X220 tool unit (located in the SUIF):
For SINGLE PLANE use X220 Generic.
For BIPLANE, use X220 Frontal and X220 Lateral.
NOTE
The acceptance criteria for Procedure is: mA tool 2389357 & only with multimeter Fluke
87 Serie 3 (this procedure requires a specific function available only on the multimeter
Fluke 87 Serie 3).
Acceptance Criteria – Rejection Limit

As a result of ± 5% due to inherent inaccuracies of the instrumentation and test method, the
rejection limits are set to ± 15%. Record the data (apply any corrective factor if required and check
final results are within acceptance criteria).
24/52 HHS 46-017561 Revision 33

• (For Innova and Allia™ IGS 5 and Allia™ IGS 3 Systems)

If your system is equipped with 24 meters HV cables - Fill in the spreadsheet with correction
related to mA_Average correction 24 m.
• (For Innova and Allia™ IGS 5 and Allia™ IGS 3 Systems) 1

• (For Discovery™ IGS systems and Allia™ IGS 7 and Allia™ IGS 7 OR Systems)
Fill in the spreadsheet with correction related to mA_Average correction 28.70 m.
Prerequisites
1. Switch OFF the system.
2. For Jedi equipped with a front cover [A], loosen the four captive screws [B] and remove the
front cover. Then go to Step 6.
If the Jedi is not equipped with a front cover [A], perform the Step 3 to Step 5.
Figure 1-6 Remove Jedi Front Cover
3. WARNING
BEFORE REMOVING JEDI INVERTER COVER, WAIT UNTIL ALL LED’S ARE
EXTENGUISH ON JEDI AC/DC BD
(For Jedi without Front Cover) For Single Plane, open C1/C-FRT Cabinet (for Biplane, open C1 FRT
or C1 LAT or C-FRT or C-LAT Cabinet) and remove the JEDI inverter cover, refer to:
(For Innova Single Plane and Discovery™ IGS Systems with C1 Cabinet) DR0187 - Jedi KVCTL
Board , steps 1 to 4 of the Disassembly procedure.
(For Innova Single Plane, Discovery™ IGS Systems and Allia™ IGS Systems and Allia™ IGS 3 with
C-FRT Cabinet) DR1161 - Jedi KVCTL Board , steps 1 to 4 of the Disassembly procedure.
(For Innova Biplane IGS Systems with C1 FRT and C1 LAT Cabinet) DR0187 - Jedi KVCTL Board ,
steps 1 to 4 of the Disassembly procedure.
(For Innova Biplane IGS Systems with C-FRT and C-LAT Cabinet) DR1161 - Jedi KVCTL Board ,
46-017561 Revision 33 HHS 25/52

(For Optima Systems) DR0871 - Jedi KVCTL Board , steps 1 to 4 of the Disassembly procedure.
4. (For Jedi without Front Cover) Install the JEDI cover tool (2404211): put in place the plastic cover
tool for JEDI inverter protection [1].
Figure 1-7 Connection of the JEDI mA Shunt Measurement Tool
5. Remove the flat cable in J1 of KVCTL board ([2], Figure 1-7 Connection of the JEDI mA Shunt
Measurement Tool on page 26).
26/52 HHS 46-017561 Revision 33

6. Plug the J1 of the JEDI mA shunt measurement tool [3] (2389357) in the J1 connector of the
KVCTL board.
Figure 1-8 mA Measurement Tool (2389357) and Multimeter Connection
1

7. Plug the flat cable in the JEDI mA shunt measurement tool (male side, connetor J3).
8. Connect the cables ([4], Figure 1-8 mA Measurement Tool (2389357) and Multimeter
Connection on page 27) of the multimeter ([5], Figure 1-8 mA Measurement Tool (2389357)
and Multimeter Connection on page 27) to the connector J4 of the JEDI mA shunt measurement
tool.
Test Procedure
mA Shunt Resistor Measurement with JEDI OFF

1. Select Ohmmeter function on FLUKE 87 serie 3.
2. Select maximum display accuracy function on FLUKE 87 serie 3 – Press the 41/2 DIGITS button
for 1 second (the 41/2 DIGITS display is switched ON).
3. Connect the FLUKE 87 serie 3 multimeter between Ground (Black pin) and Shunt A (Red pin) on
the external tool.
4. Record the Shunt A resistor value with 2 decimal places (measured around 5 ohms).
5. Connect the FLUKE 87 serie 3 multimeter between Ground (Black pin) and Shunt B (Blue pin) on
the external tool.
6. Record the Shunt B resistor value with 2 decimal places (measured around 0 ohm).
mA Shunt Resistor Accuracy Verification

1. Record and compile values according to Table 1-14 Test Angio Parameters on page 29 and
Table 1-15 Test Cardiac Parameters on page 29.
2. The rejection limit is 5 ohms ± 2%.
46-017561 Revision 33 HHS 27/52
Power ON the System

1. Verify connection of the FLUKE 87 serie 3 multimeter between Shunt A (Red pin) and Shunt B
(Blue pin) on the mA tool.
2. For security, be sure the inverter cover tool is installed and secured with screws.
3. Power ON the system to carry out the following tests.
Measurement procedure
1. Put in place the DLB (Detector Lead Blocker).
2. Select the FLUKE 87 serie 3 multimeter in Vdc voltage function with 4 V Range. Select the
Mode Record MAX display with a response time of 1 second. To achieve this mode carry out the
following actions:
a. Press the 4 1/2 DIGITS button for 1 second (the 41/2 DIGITS display is switched ON).
b. Press briefly the MIN MAX button 1st time - a long time Bip is emitted (the Mode 1s REC is
switched ON).
c. Press briefly the MIN MAX button 2nd time - (the Mode 1s REC MAX is switched OFF).
3. Set the system in manual mode using the X220 unit in the SUIF (refer to Figure 1-9 X220
Unit on page 28).
a. Enter in the SUIF (on the DL browser, click on the knife tool icon).
Figure 1-9 X220 Unit
b. Click on Calibration button.

c. Select HHS and Dose Measurement.
d. Select X220 Generic (for Single Plane) or Select X220 Frontal or X220 Lateral (for
Biplane).
28/52 HHS 46-017561 Revision 33

4. Choose exposure technics parameters according to the Tables listed below.

Table 1-14 Test Angio Parameters
Fluke 87 serie 3 Range Measurement on 4 Vdc Test 1 Test 2 Test 3 Test 4 Test 5 Test 6
1
Exp Mode DSA DSA DSA DSA DSA DSA

Frame Rate 3.75 fps 3.75 fps 3.75 fps 3.75 fps 3.75 fps 3.75 fps
Focal Spot 0.3 0.3 0.6 0.6 1 1
kVPeak 50 125 50 125 50 125
mAPeak 40 40 80 80 200 200
Pulse Width 100 ms 100 ms 100 ms 100 ms 100 ms 100 ms
Spectral Filter None None None None None None
DLB Presence Yes Yes Yes Yes Yes Yes
Collimator LONG Leave Empty
Collimator LAT Leave Empty
Table 1-15 Test Cardiac Parameters
Fluke 87 serie 3 Range Measurement on 4 Vdc Test 7 Test 8 Test 9 Test 10

Exp Mode Cardiac Cardiac Cardiac Cardiac
Frame Rate 30 fps 30 fps 30 fps 30 fps
Focal Spot 0.6 0.6 1 1
kVPeak 60 120 60 120
mAPeak 80 80 200 200
Pulse Width 9 ms 9 ms 9 ms 9 ms
Spectral Filter None None None None
DLB Presence Yes Yes Yes Yes
5. Select Spectral filter: None, DLB presence = Yes, Collimator Long / Lat: Leave empty.
6. Select SUBMIT to set all parameters.
7. Depress the hand switch to initiate the X–Ray exposure during approximately 10 to 20 seconds
to allow multimeter acquisition stabilization (Maintain the X–Ray exposure until FLUKE 87 serie
3 multimeter stop to bip for maximum value recorded).
8. Record the multimeter voltage value displayed.
9. Record the mA_average value updated at exposure end displayed in the X220 status bar (refer
to Figure 1-9 X220 Unit on page 28).
10. Record and compile values according to Table 1-14 Test Angio Parameters on page 29 and Table
1-15 Test Cardiac Parameters on page 29.
11. After each measurement, RESET the FLUKE 87 serie 3 displayed value:
• Press a long time (1 s) the MIN MAX button 1st time - (the Mode 1s REC is switched OFF).
• Press briefly the MIN MAX button 2nd time - (the Mode 1s REC is switched ON).
• Press briefly the MIN MAX button 3rd time - (the Mode 1s REC MAX is switched ON).
12. Repeat all previous actions to perform all 10 tests.
46-017561 Revision 33 HHS 29/52

13. When all tests are performed, click on ABORT to exit.
SpreadSheet fill in procedure

1. Fill in data
a. Before data fill in, choose the right spreadsheet in accordance to your system as SP and
Frontal for Single Plane or Frontal Biplane, and Lateral for Lateral Biplane.
b. Furthermore, in each spreadsheet you need to select the High Voltage cable length
equipment (24 meters or 28.7 meters or 30 meters) and the mA measurement tool
procedure, after, you will be able to enter the following values:
• The measured resistor values (in Ohm, with 2 decimal places) displayed on multimeter.
• The measured voltage (in mVdc) displayed on multimeter.
• The mA_avg value (in mA) displayed on X220 status bar.
2. Computation Details
a. For mA Shunt resistor verification test:
A calculated mA Shunt resistor value is automatically computed as following formula –––>
(Shunt A resistor - Shunt B resistor); the rejection limits are 4.90 Ohm (LSL) and 5.10 Ohm
(USL) for PASS / FAIL test.
b. For each mA accuracy station test:
• A calculated mA_avg value (without correction) is automatically computed as following
formula –––> (mVdc / 5Ω).
• A corrected mA_avg value (with correction) is automatically computed as following
formula –––>[(mVdc / 5Ω) – mA_avg correction value @ HV cable length] see following
Table for mA_avg correction values.
• This corrected mA_avg value is automatically compared to the rejection limit @
selected mA measurement tool procedure (see following Table for rejection limit
values) for PASS / FAIL test.
• The mA_avg value returned in X220 status bar is automatically compared to the
rejection limit (see following Table for rejection limit values) for PASS / FAIL test.
NOTE
For Discovery™ IGS Systems and Allia™ IGS Systems and Allia™ IGS 3 refer to
column “mA_avg correction value @ 28.70 m HV cable (mA)”.
TEST No. mA_avg cor- mA_avg cor- mA_avg cor- LSL ejection mA_avg De- USL rejec-
rection val- rection val- rection val- limit (–15% mand value tion limit
ue @ 24 m ue @ 28.70 ue @ 30 m of mA_avg (mA) (+15% of
HV cable m HV cable HV cable Demand) mA_avg De-
(mA) (mA) (mA) (mA) mand) (mA)
1 0.46 0.51 0.53 12.75 15 17.25
2 1.16 1.28 1.31 12.75 15 17.25
3 0.48 0.53 0.55 25.5 30 34.5
4 1.21 1.33 1.37 25.5 30 34.5
5 0.55 0.60 0.61 63.75 75 86.25
6 1.37 1.49 1.53 63.75 75 86.25
7 0.15 0.15 0.15 18.36 21.6 24.84
8 0.30 0.30 0.30 18.36 21.6 24.84
9 4.83 5.31 5.44 45.9 54 62.1
30/52 HHS 46-017561 Revision 33

Control and Tube Assembly Tests 1.8 REG0057 - Tech & Manual mA Accuracy - Tool 2389357-2 or 5480040
or 5507803
TEST No. mA_avg cor- mA_avg cor- mA_avg cor- LSL ejection mA_avg De- USL rejec-
rection val- rection val- rection val- limit (–15% mand value tion limit
ue @ 24 m ue @ 28.70 ue @ 30 m of mA_avg (mA) (+15% of
HV cable m HV cable HV cable Demand) mA_avg De-
(mA) (mA) (mA) (mA) mand) (mA)
1
10 9.67 10.62 10.88 45.9 54 62.1

3. Removal the mA Shunt Tool and JEDI Cover Tool
a. Switch OFF the system.
b. WARNING
BEFORE REMOVING JEDI INVERTER COVER TOOL, WAIT UNTIL ALL LED’S ARE
EXTINGUISHED ON JEDI AC/DC BD.
Remove the multimeter.
c. (For Jedi without Front Cover) Remove the inverter cover tool (2404211).
d. Remove the mA shunt tool (2389357).
e. Reinstall the flat cable in the J1 connector.
f. (For Jedi with Front Cover) Reinstall the front cover and attach it with the four captive
screws.
g. (For Jedi without Front Cover) Reinstall the Inverter metallic cover, refer to:
Board , Reassembly procedure.
(For Innova Single Plane, Discovery™ IGS Systems and Allia™ IGS Systems and Allia™ IGS 3
with C-FRT Cabinet) DR1161 - Jedi KVCTL Board , Reassembly procedure.
(For Innova Biplane IGS Systems with C1 FRT and C1 LAT Cabine) DR0187 - Jedi KVCTL
Reassembly procedure.
(For Optima Systems) DR0871 - Jedi KVCTL Board , Reassembly procedure.
h. Close Auxiliary ACDC assembly in the C1/C-FRT cabinet.
i. Remove the Lead Blocker.
j. Switch ON the system.
k. Carry out an X–ray expose to control the system operation.
Finalization
1.8 REG0057 - Tech & Manual mA Accuracy - Tool

2389357-2 or 5480040 or 5507803

ments
46-017561 Revision 33 HHS 31/52

1.8 REG0057 - Tech & Manual mA Accuracy - Tool 2389357-2 or 5480040 Control and Tube Assembly Tests
or 5507803

Detector Lead Block- 1 Innova, Discovery™ 2337600 -
er IGS Systems and Al-
lia™ IGS Systems, 40
cm detector
Detector Lead Block- 1 Innova, Discovery™ 2396564 -
er IGS Systems and Al-
lia™ IGS Systems and
Allia™ IGS 3, 30 cm
detector
Detector Lead Block- 1 Innova Systems and 5125039 -
er Allia™ IGS 5 Systems,
20 cm detector
Detector Lead Block- 1 Optima CL320i/ 5413024 -
er CL323i, Optima IGS
Plus, and Optima IGS
330
Detector Lead Block- 1 Optima IGS Plus, Op- 5488772 -
er tima IGS 320
JEDI mA measure- 1 Innova, Discovery™ 2389357-2 -
ment external tool IGS Systems and Al-
lia™ IGS Systems and
Allia™ IGS 3
JEDI mA measure- 1 Optima Systems 5480040 -
ment external tool
JEDI mA measure- 1 Optima Systems 5507803 -
ment external tool
JEDI tool cover 1 All systems 2404211 -
JEDI tool cover 1 Innova single plane, 2404211-20 -
Discovery™ IGS Sys-
tems and Allia™ IGS
Systems and Allia™
IGS 3
JEDI tool cover 1 Optima IGS systems 5480038 -
Standard Field Engi- 1 - - -
neering Tools with
metric and US
wrenches
Multimeter with volt- 1 - - -
age accuracy ≤ 0.1
%. A multimeter with
min/max function is
preferred for easy
use.
Table 1-18 Safety
WARNING

32/52 HHS 46-017561 Revision 33

or 5507803

The X–Ray tube mA _ Average com- - -
puted value with applied correction 1
(mA_Average correction 24 m or
mA_Average correction 28.70 m or

mA_Average correction 30 m) should
be within ± 20% of the mA_Average
Demand value.
The actual mA_average value updat- - -
ed at exposure end, available in the
X220 status bar, should be within ±
20% of the mA_Average Demand val-
ue.
Application
This procedure is applicable 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 and Optima IGS 330.
Discovery™ IGS 730, Discovery™ IGS 740 systems orDiscovery™ IGS 7 and Discovery™ IGS 7 OR
systems are also named DiscoveryTM IGS Systems. The procedure is applicable indifferently to
This test plan will be performed in all following cases:
• System installation
NOTE
It is not required during System installation if the JEDI, the Ingrid and the X-Ray tube
are paired.
(For Innova IGS 5, Discovery IGS 7 Systems) Refer to IST0106 - X-Ray Tube Installation
or (For X-Ray Tube with Tube Holder) IST0507 - X-Ray Tube Installation.
(For Allia™ IGS Systems and Allia™ IGS 3) Refer to IST0507 - X-Ray Tube Installation
(For Innova IGS 6) Refer to IST0169 - Lateral X-Ray Tube Installation and IST0171 -
Frontal X-Ray Tube Installation.
• System repair
Purpose
The tests described (see Table 1-20 Test Angio Parameters on page 37 and Table 1-21 Test Cardiac
Parameters on page 38) in this evaluation plan verify the accuracy of the X–Ray tube mA_Average
in all following system acquisition modes for kV_MIN and kV_MAX at mA peak tube current equal to
20% of the highest tube current.
• Angio mode (on Compressed, Small and Large focus)
• Cardiac mode (on Small and Large focus)
NOTE
The FLUORO acquisition mode is not performed because it is the same as Cardiac on
Small focus
46-017561 Revision 33 HHS 33/52

or 5507803
The X–Ray tube mA _ Average is measured with an external tool and a multimeter in
manual mode using the X220 tool unit (located in the SUIF):
For SINGLE PLANE use X220 Generic.
For BIPLANE, use X220 Frontal and X220 Lateral.
NOTE
The acceptance criteria for Procedure is: mA tool 2389357-2 & a multimeter with voltage
accuracy ≤ 0.1 %, input impedance ≥10 Mohm, the ohmmeter function with accuracy ≥ 0.2
% and resolution < 0.1 ohm. A multimeter with min/max function is preferred for easy use.
Acceptance Criteria – Rejection Limit

As a result of ± 8% due to inherent inaccuracies of the instrumentation and test method, the
rejection limits are set to ± 12%. Record the data (apply any corrective factor if required and check
final results are within acceptance criteria).
• (For Innova, Optima Systems and Allia™ IGS 5 Systems and Allia™ IGS 3)
• (For Innova, Optima Systems and Allia™ IGS 5 Systems and Allia™ IGS 3)
• (For Discovery™ IGS Systems and Allia™ IGS 7 and Allia™ IGS 7 OR Systems)
Fill in the spreadsheet with correction related to mA_Average correction 28.70 m.
Prerequisites
1. Switch OFF the system.
2. For Jedi equipped with a front cover [A], loosen the four captive screws [B] and remove the
front cover. Then go to Step 6.
If the Jedi is not equipped with a front cover [A], perform the Step 3 to Step 5.
Figure 1-10 Remove Jedi Front Cover
34/52 HHS 46-017561 Revision 33

or 5507803
3. WARNING
BEFORE REMOVING JEDI INVERTER COVER, WAIT UNTIL ALL LED’S ARE
EXTENGUISH ON JEDI AC/DC BD
1
(For Jedi without Front Cover) For Single Plane, open C1/C-FRT Cabinet (for Optima IGS systems,
open System control cabinet; for Biplane, open C1 FRT or C1 LAT or C-FRT or C-LAT Cabinet) and

remove the JEDI inverter cover, refer to:
Board , steps 1 to 4 of the Disassembly procedure.
(For Innova Single Plane, Discovery™ IGS Systems and Allia™ IGS Systems and Allia™ IGS 3 with
C-FRT Cabinet) DR1161 - Jedi KVCTL Board , steps 1 to 4 of the Disassembly procedure.
(For Innova Biplane IGS Systems with C1 FRT and C1 LAT Cabinet) DR0187 - Jedi KVCTL Board ,
(For Optima Systems) DR0871 - Jedi KVCTL Board , steps 1 to 4 of the Disassembly procedure.
4. (For Jedi without Front Cover) Install the JEDI cover tool (2404211 or 2404211-20 or 5480038):
put in place the plastic cover tool for JEDI inverter protection [1].
Figure 1-11
5. Remove the flat cable in J1 of KVCTL board ([2], Figure 1-11 on page 35).
46-017561 Revision 33 HHS 35/52

or 5507803
6. Plug the J1 [3] of the JEDI mA shunt measurement tool [4] (2389357-2 or 5480040/5507803) in
the J1 connector of the KVCTL board.
Figure 1-12
7. Plug the flat cable in the JEDI mA shunt measurement tool (male side, connector J3) ([5], Figure
1-12 on page 36).
8. Connect the cables ([6], Figure 1-12 on page 36) of the multimeter ([7], Figure
1-12 on page 36) to the banana plugs (mA and shunt–B) of the JEDI mA shunt measurement
tool.
Test Procedure
mA shunt resistor measurement with JEDI OFF

1. Select Ohmmeter function on multimeter.
2. Select maximum display accuracy function on multimeter.
3. Connect the multimeter between Ground (Black pin) and Shunt A (Red pin) on the mA tool.
4. Record the Shunt A resistor value with 2 decimal places (measured around 5 ohms).
5. Connect the multimeter between Ground (Black pin) and Shunt B (Blue pin) on the mA tool.
6. Record the Shunt B resistor value with 2 decimal places (measured around 0 ohm).
mA Shunt resistor accuracy verification

1. Record and compile values according to Table 1-20 Test Angio Parameters on page 37 and
Table 1-21 Test Cardiac Parameters on page 38.
2. The rejection limit is 5 ohms ± 2%.
Power ON the System

1. Verify connection of the multimeter between ”mA” (Green pin) and Shunt B (Blue pin) on the mA
tool.
2. For security, be sure the inverter cover tool is installed and secured with screws.
3. Power ON the system to carry out the following tests.
36/52 HHS 46-017561 Revision 33

or 5507803
Measurement procedure
1. Put in place the DLB (Detector Lead Blocker).
2. Select the multimeter in Vdc voltage function. 1
3. Select the Record MAX display Mode (if not available on the multimeter, the operator must read

the maximum value displayed on the multimeter during each measurement).
4. Set the system in manual mode using the X220 unit in the SUIF (refer to Figure
1-13 on page 37).
a. Enter in the SUIF (on the DL browser, click on the knife tool icon).
Figure 1-13
b. Click on Calibration button.

c. Select HHS and Dose Measurement.
d. Select X220 Generic (for Single Plane) or Select X220 Frontal or X220 Lateral (for
Biplane).
5. Choose exposure technics parameters according to the Tables listed below.
Table 1-20 Test Angio Parameters
Multimeter Range Measurement on Vdc Test 1 Test 2 Test 3 Test 4 Test 5 Test 6
Exp Mode DSA DSA DSA DSA DSA DSA
Frame Rate 3.75 fps 3.75 fps 3.75 fps 3.75 fps 3.75 fps 3.75 fps
Focal Spot 0.3 0.3 0.6 0.6 1 1
kVPeak 50 125 50 125 50 125
mAPeak 40 40 80 80 200 200
Pulse Width 100 ms 100 ms 100 ms 100 ms 100 ms 100 ms
Spectral Filter None None None None None None
DLB Presence Yes Yes Yes Yes Yes Yes
46-017561 Revision 33 HHS 37/52

or 5507803
Table 1-20 Test Angio Parameters (Table continued)
Multimeter Range Measurement on Vdc Test 1 Test 2 Test 3 Test 4 Test 5 Test 6
Table 1-21 Test Cardiac Parameters
Multimeter Range Measurement on Vdc Test 7 Test 8 Test 9 Test 10

Exp Mode Cardiac Cardiac Cardiac Cardiac
Frame Rate 30 fps 30 fps 30 fps 30 fps
Focal Spot 0.6 0.6 1 1
kVPeak 60 120 60 120
mAPeak 80 80 200 200
Pulse Width 9 ms 9 ms 9 ms 9 ms
Spectral Filter None None None None
DLB Presence Yes Yes Yes Yes
6. Select Spectral filter: None, DLB presence = Yes, Collimator Long / Lat: Leave empty.
8. Depress the hand switch to initiate the X–Ray exposure during approximately 20 seconds to
allow multimeter acquisition stabilization (Maintain the X–Ray exposure until maximum value is
recorded by multimeter).
9. Record the multimeter voltage value displayed.
10. Record the mA_average value updated at exposure end displayed in the X220 status bar.
11. Record and compile values according to Table 1-20 Test Angio Parameters on page 37 and Table
1-21 Test Cardiac Parameters on page 38.
12. After each measurement, if the max record mode is used, reinitialize the multimeter for a new
record.
13. Repeat all previous actions to perform all 10 tests.
14. When all tests are performed, click on ABORT to exit.
SpreadSheet fill in procedure

1. Fill in data
a. Before data fill in, choose the right spreadsheet in accordance to your system as SP and
Frontal for Single Plane or Frontal Biplane, and Lateral for Lateral Biplane.
b. Furthermore, in each spreadsheet you need to select the High Voltage cable length
equipment (24 meters or 28.7 meters or 30 meters) and the mA measurement tool
procedure, after, you will be enter the following values:
• The measured resistor values (in Ohm, with 2 decimal places) displayed on multimeter.
• The measured voltage (in mVdc) displayed on multimeter.
• The mA_avg value (in mA) displayed on X220 status bar.
2. Computation Details
38/52 HHS 46-017561 Revision 33

or 5507803
a. For mA Shunt resistor verification test:

A calculated mA Shunt resistor value is automatically computed as following formula –––
>(Shunt A resistor - Shunt B resistor); the rejection limits are 4.90 Ohm (LSL) and 5.10 Ohm
(USL) for PASS / FAIL test.
1
b. For each mA accuracy station test:

• A calculated mA_avg value (without correction) is automatically computed as following
formula–––>(mVdc / 5Ω).
• A corrected mA_avg value (with correction) is automatically computed as following
formula –––>[(mVdc / 5Ω) – mA_avg correction value @ HV cable length] see following
Table for mA_avg correction values.
• This corrected mA_avg value is automatically compared to the rejection limit @
selected mAmeasurement tool procedure (see following Table for rejection limit values)
for PASS / FAIL test.
• The mA_avg value returned in X220 status bar is automatically compared to the
rejection limit (the Table for rejection limit values is the same as Procedure A (± 15%))
for PASS / FAIL test.
NOTE
For DiscoveryTM IGS systems refer to column “mA_avg correction value @
28.70 m HV cable (mA)”.
TEST No. mA_avg cor- mA_avg cor- mA_avg cor- LSL rejec- mA_avg De- USL rejec-
rection val- rection val- rection val- tion limit (– mand value tion limit
ue @ 24 m ue @ 28.70 ue @ 30 m 12% of (mA) (+12% of
HV cable m HV cable HV cable mA_avg De- mA_avg De-
(mA) (mA) (mA) mand) (mA) mand) (mA)
1 0.46 0.51 0.53 13.2 15 16.8
2 1.16 1.28 1.31 13.2 15 16.8
3 0.48 0.53 0.55 26.4 30 33.6
4 1.21 1.33 1.37 26.4 30 33.6
5 0.55 0.60 0.61 66 75 84
6 1.37 1.49 1.53 66 75 84
7 0.15 0.15 0.15 19.01 21.6 24.19
8 0.30 0.30 0.30 19.01 21.6 24.19
9 4.83 5.31 5.44 47.52 54 60.48
10 9.67 10.62 10.88 47.52 54 60.48
3. Removal the mA Shunt Tool and JEDI Cover Tool

a. Switch OFF the system.
b. WARNING
BEFORE REMOVING JEDI INVERTER COVER TOOL, WAIT UNTIL ALL LED’S ARE
EXTINGUISHED ON JEDI AC/DC BD.
Remove the multimeter.
c. (For Jedi without Front Cover) Remove the inverter cover tool (2404211 or 2404211-20 or
5480038).
d. Remove the mA shunt tool (2389357-2 or 5480040 or 5507803).
e. Reinstall the flat cable in the J1 connector.
46-017561 Revision 33 HHS 39/52

1.9 REG0058 - Technique Accuracy - kV (20, 30 and 40 cm Detector) Control and Tube Assembly Tests
f. (For Jedi with Front Cover) Reinstall the front cover and attach it with the four captive
screws.
g. (For Jedi without Front Cover) Reinstall the Inverter metallic cover, refer to:
(For Innova Single Plane and Discovery™ IGS Systems and Allia™ IGS Systems and Allia™ IGS 3
with C-FRT Cabinet) DR1161 - Jedi KVCTL Board , Reassembly procedure.
(For Innova Biplane IGS Systems with C1 FRT and C1 LAT Cabinet) DR0187 - Jedi KVCTL
Reassembly procedure.
(For Optima Systems) DR0871 - Jedi KVCTL Board , Reassembly procedure.
h. Close Auxiliary ACDC assembly in the C1/C-FRT cabinet (or System control cabinet for
Optima IGS systems).
i. Remove the Lead Blocker.
j. Switch ON the system.
k. Carry out an X–Ray expose to control the system operation.
Finalization
1.9 REG0058 - Technique Accuracy - kV (20, 30 and 40

cm Detector)

ments
1 10 minutes 45 minutes 10 minutes

Non-invasive divider 1 - - -
with an accuracy ≤ ±
3% as recommended
in Illustrations of this
procedure
40/52 HHS 46-017561 Revision 33

Control and Tube Assembly Tests 1.9 REG0058 - Technique Accuracy - kV (20, 30 and 40 cm Detector)
Table 1-24 Safety
WARNING
RISK OF ELECTRIC SHOCK.

1
HAZARDOUS VOLTAGE PRESENT.

WARNING
BEFORE ANY INTERVENTION SWITCH OFF THE SYSTEM (REFER TO PROTECTION

AGAINST ELECTRICAL HAZARDS IN SAFETY AND REGULATORY).
WARNING

• Application: kVp accuracy test must be performed at installation and repair (Generator FRU, HV
tank, PPC kV CTL Board).
• Requirements: “Specified Accuracy” refers to technical accuracy statements written in Product
Specification section of operator manuals.
kVp Accuracy: Displayed kVp shall match the measured value within the specified accuracies.
NOTE
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.
Procedure
1. Use the non–invasive divider with an accuracy =< ± 3% as recommended in Illustrations below.
Figure 1-14 Detector Positioning for kVp Measurement
46-017561 Revision 33 HHS 41/52

1.9 REG0058 - Technique Accuracy - kV (20, 30 and 40 cm Detector) Control and Tube Assembly Tests
Figure 1-15 Detector Positioning (vertical) for kVp Measurement
2. In SUIF, set the system in manual mode using the X220 unit in HHS and Dose Measurements
from Calibration.
3. Select:
a. Expose Mode: DSA
b. Frame Rate: 3.75 fps
c. Focal Spot: 1
d. kVpeak, mApeak, Pulse Width: Refer to Table 1-25 on page 43.
e. Spectral filter: None
f. DLB presence = Yes
g. Collimator Long / Lat: Let empty.
5. Perform the exposures under the parameters specified in the table below and at each end of
exposures fill in the table below with both the kVp displayed (check in X220 display status bar)
and the kVp measured.
6. If the kVp measures are out the specifications limits, change the PPC kV CTL Board, refer to:
(For Innova and Discovery™ IGS Systems) DR0187 - Jedi KVCTL Board.
(For Allia™ IGS Systems and Allia™ IGS 3) DR1161 - Jedi KVCTL Board.
(For Optima Systems) DR0871 - Jedi KVCTL Board.
or (and) the HV tank, refer to:
(For Innova and Discovery™ IGS Systems) DR0191 - Jedi Inverter or HV Tank.
(For Allia™ IGS Systems and Allia™ IGS 3) DR1163 - Jedi Inverter or HV Tank.
(For Optima Systems) DR0874 - Jedi Inverter or HV Tank.
42/52 HHS 46-017561 Revision 33

Control and Tube Assembly Tests 1.10 REG0059 - Technique Accuracy - mAs
Table 1-25
Mode: DSA on large Focus spot (Cine HP generator mode)

Test # kV mA Pulse Width fps Displayed Lower Spec. Measured Upper Spec.
(ms) kVp Limit (kVp) = kVp (actual Limit (kVp) = 1
Displayed kVp x kVp) Displayed kVp x
0.93 1.07

Test 1 75 150 100 3.75
Test 2 100 150 100 3.75
Figure 1-16
7. Record the data (apply any corrective factor if required and check final results are within
Finalization
1.10 REG0059 - Technique Accuracy - mAs


ments

When the equipment is connected to - -
an adequate power supply as speci-
fied, the deviation of the tube cur-
rent/exposure time product shall not
exceed the limits given in specifica-
tions.
Application
AMX, VMX, MPX/SPX, Advantx, and any other controls that have mAs settings; at installation,
preventive maintenance calls, after repair or replacement of mAs or timer circuits, and replacement
of tube unit. If the control allows selections of mAs in addition to the normal selection of mA and
time, then you must perform this test in addition to tests for mA and time.
46-017561 Revision 33 HHS 43/52

1.11 REG0060 - Indirect Linearity Control and Tube Assembly Tests
Procedure
1. Procedures for making this test are given in the individual service manual functional check. Also
refer to REG0054 - Technique Accuracy - Generator Timer on page 18.
2. Record data: enter required data on Form 3382 on laptop computer.
Finalization
1.11 REG0060 - Indirect Linearity


ments

For convenience, this test uses kVp - -
and mA accuracy data for an indirect
test of linearity. If system passes test
of REG0054 - Technique Accuracy -
Generator Timer on page 18, this
section is also satisfied and no fur-
ther testing is necessary.
Application
Linearity: Radiographic and Spot-Film tube units supplied by the same generator. At installation,
periodic maintenance, and repair. The requirements apply even across focal spots, e.g., highest mA
on small spot compared to low mA on large spot. An exception is if the small spot is .45 mm or
less. For equipment manufactured after May 3, 1994, the requirements will be extended to units that
have only mAs selections.
Linearity requirements apply to all tube units used directly for filming and which can be operated at
more than one mA station. Consequently, linearity requirements do not apply to:
• Spot-film tube operated at one mA value.
• Tube used only with an image intensifier, whether for fluoro or for recording.
Procedure
NOTE
If a system passes the Indirect Linearity test, there’s no need to perform the Direct
Linearity test, unless some of the indirect test data is marginal. If System fails Indirect
Linearity you must either verify compliance via the Direct Linearity Test or readjust the
system and perform the Indirect Test again.
1. Perform test of REG0054 - Technique Accuracy - Generator Timer on page 18.
2. Ensure the test is passed.
Finalization
44/52 HHS 46-017561 Revision 33

Control and Tube Assembly Tests 1.12 REG0061 - AEC Maximum mAs
1.12 REG0061 - AEC Maximum mAs

1

ments

At tube potentials of 50 kV or more, - -
exposures may not exceed 600 mAs
per exposure: below 50 kV, expo-
sures may not exceed 2,000 mAs.
Requirements do not apply under
any type of equipment failure mode.
Application
X-Ray units with AEC at installation, and periodic maintenance. Does not apply to image intensifiers.
For Advantx Systems

Use the Calibration Tool Unit T005 MAS Integrator Test, from the appropriate Advantx Calibration
User’s Guide Direction, to functionally test the 600 mAs backup mAs integrator.
For Non-Advantx Systems

Procedure is covered in the Functional Check chapter of the appropriate generator or automatic
exposure control service manual.
Record Data
Record that requirements have been met on laptop computer Form 3382.
Finalization
1.13 REG0062 - AEC Minimum Exposure Time


ments

At 50 kV or more, minimum expo- - -
sures must be less than 16 ms or
less than the time to deliver 5 mAs,
whichever time is greater.
Application
46-017561 Revision 33 HHS 45/52

1.14 REG0063 - Reproducibility Of Exposure Control and Tube Assembly Tests
X-Ray units with AEC, at installation and periodic maintenance. Does not apply to image intensifiers.
Procedure
1. Set 50 kV, normal AEC density, max. mA, .1 s (or 10 mAs) backup.
2. Align X-Ray beam to detector per standard technique.
3. Lower tube to 40 SID if possible, otherwise set for minimum.
4. Remove all phantoms.
5. Make an exposure in AEC mode.
6. The exposure must either be less than 16 ms, or less than 5 mAs.
7. Repeat the above procedure for each detector segment and for all detectors in the room. Do not
re-align the X-Ray beam to individual detector segments.
8. Record data: record that requirements have been met on laptop computer Form 3382.
Finalization
1.14 REG0063 - Reproducibility Of Exposure


ments

Radiation meter with 1 - - -
integrate mode.
Probe test stand. 1 - - -
Table 1-36 Consumables

1–1/2 (3.8 cm) thick- AR - - -
ness of aluminum
(from HHS kit), for
use with A.E.C. sys-
tems only.
46/52 HHS 46-017561 Revision 33

Control and Tube Assembly Tests 1.14 REG0063 - Reproducibility Of Exposure

For any specific combination of se- - -
lected technique factors, the esti- 1
mated coefficient of variation, C.V.,
of radiation exposures shall be no

greater than 0.05. Rejection limit
0.045. This requirement holds for
exposures made with and without
use of A.E.C. This does not apply to
image intensified applications, cine,
photospot or digital.
Application
At installation, preventive maintenance, and repair.
Procedure 1 - For exposures made with an A.E.C

If system passes Procedure 1 - For exposures made with an A.E.C on page 47, there is no need
to perform Procedure 2 - For exposures made without the use of A.E.C on page 47. Follow the
instructions that pop up on the laptop computer Form 3382 for this test.
1. For overhead X-Ray tubes, place 1–1/2 (3.8 cm) aluminum on the table. Center the radiation
probe 30 cm (12 in.) above the table. Adjust the SID to about 100 cm. Align the bucky. For
undertable X-Ray tubes, assemble the attenuation block assembly from the HHS kit and place
it on the table. Center the probe beneath the assembly. Position the spot-filmer about 30 cm
above the table.
2. Collimate to a field about 5 inches square (13 cm square).
3. Select 80 kVp and mA such that the exposures will be at least 0.1 second long.
4. NOTE
Test is applicable at any kVp and mA setting.
Measure the exposure in mR for each of 10 exposures (data sheet provided). After each
exposure, recycle the rotor and the technique switches; that is, set the switches to other values
and then return them to the original values. Be sure to vary the time between spot-film transfer
and exposure start to record any filament heating variations.
5. Enter the data onto the laptop computer Form 3382. If system fails this test, there may be a
defective ion chamber.
Procedure 2 - For exposures made without the use of A.E.C

1. For either overhead or undertable X-Ray tubes, place the probe at approximately 100 cm from
the focal spot. Avoid probe saturation (refer to 46–017560, HHS TOOLS).
2. Select 80 kVp, 0.1 second, and 400 mA to yield 100 mR to 300 mR per exposure.
3. NOTE
Test is applicable at any kVp and mA setting.
Collimate to a field approximately 5 inches square, (13 cm square).
4. Measure the mR for each of 10 exposures. After each exposure, recycle the rotor and the technic
switches; that is, set the switches to other values and then return them to the original values.
Be sure to vary the time between spot–film transfer and exposure start to take into account any
filament heating variations.
system defect. Repair as necessary.
46-017561 Revision 33 HHS 47/52

1.15 REG0064 - Direct Linearity Of Exposure Alternate Method Control and Tube Assembly Tests
Procedure 3 - For tomographic systems

NOTE
If the system is operable in non-tomo mode, the previous two procedures are also
applicable.
1. Place the probe on a stand 10 cm above the table. Adjust the focal plane height to 10 cm. On
transaxial systems, use the collimator light field to determine the appropriate height for the
probe.
2. Select common tomographic technique factors, e.g., 80 kVp, 100 mA, and adjust for a large
sweep angle at medium speed.
3. Make a sweep without radiation, and, using the collimator light field, ensure that the probe is
contained within the field during the entire sweep.
4. Select backup time longer than sweep time and measure the exposure in mR for each of 10
sweeps. After each exposure, recycle the rotor and the technique switches; that is, set the
switches to other values and then return them to the original values. Observe tomo motor
cooling times.
defective ion chamber.
Table 1-38 Mini-Troubleshooting Guide
Problem Possible Cause

Coefficient of • Poor kVp reproducibility (deadband). In AEC mode this affects kVp compensation on
variation too some systems.
high • Improper rotor acceleration delay, improper spotfilm transfer delay, improper filament
boost. All of these will determine if filament is up to temperature when exposure
occurs. On AEC systems, a variable filament temperature results in kVp variations
which lead to kVp compensation errors.
• On Tomographic Systems, variations in sweep speed or angle will affect reproducibility.
Always test the non-tomo mode first.
• Line voltage regulation out of specification.
Finalization
1.15 REG0064 - Direct Linearity Of Exposure Alternate

Method

ments

integrated mode.
Probe test stand 1 - - -
48/52 HHS 46-017561 Revision 33

Control and Tube Assembly Tests 1.15 REG0064 - Direct Linearity Of Exposure Alternate Method
Application - For radiographic modes without AEC:

At installation, preventive maintenance, and repair. Use this method whenever indirect linearity test
fails.
Requirements
1

1. The average ratios of exposure to the selected mAs (mR/mAs) obtained at any two consecutive
tube current settings, shall not differ by more than 0.10 times their sum (rejection limit = 0.09).
That is:
where and are the averages of 10 mR/mAs values obtained at each of two consecutive
tube current settings.
NOTE
If the above relationship is rewritten as: then the

term on the right can be referred to as the coefficient of linearity. So defined, we
can state the requirement as the coefficient of linearity (C.L.)” shall not exceed
0.10 (rejection limit = 0.09).
2. You must make 10 exposures per mA station and not 4 as is common for FDA inspection.
Remember that the FDA is merely looking for non-compliance, but you are trying to prove
compliance (passing a test with 4 exposures does not guarantee compliance).
Procedure
1. For overhead X–Ray tubes, place the probe approximately 100 cm (39.37 in.) from the focal spot.
For undertable X-Ray tubes, attach the probe to a stand and place it about 30 cm (12 in.) above
the table.
2. Select kVp and mA equal to the values where the system failed or was marginal in the Indirect
Linearity Test. Adjust timer to at least .01 seconds but not less than 20 mAs.
3. Collimate to a field about 5 inches square (13 cm square).
4. Set the rate meter to integrate mode and measure the total exposure for 10 exposures. Recycle
the rotor but not the technique switches after each exposure.
5. Enter the data onto the laptop computer form. If system fails this test, refer to Table 1-41 Mini–
Troubleshooting Guide on page 49.
Table 1-41 Mini–Troubleshooting Guide

C.L. too high • mA accuracy out of specification.
• Timer accuracy out of specification.
• Probe saturation (refer to REG0052 - Generator Operator Indicators on page 15, Probe
Saturation Effects).
• Excessive cable capacitance due to very long cables combined with low mA selection – long
decay time.
• Line voltage regulation out of specification.
• Test not completed within one-hour limit.
46-017561 Revision 33 HHS 49/52

1.15 REG0064 - Direct Linearity Of Exposure Alternate Method Control and Tube Assembly Tests
Figure 1-17 Direct Linearity Chart
Finalization
50/52 HHS 46-017561 Revision 33

Buc 78530 FRANCE
HHS
Beam Quality Test
46-017562
Revision 29
US English
Beam Quality Test
WARNING
devices be used.
Language Policy

работа.
опасност.
害。
46-017562 Revision 29 HHS 3/26

Beam Quality Test

priručnik.
jeho obsah.
či jiných rizik.
gevaren.
understood.
ohjeen.
4/26 HHS 46-017562 Revision 29

Beam Quality Test

den zu haben.
kommen.
nem értelmezték.
い。
46-017562 Revision 29 HHS 5/26

Beam Quality Test

시오.
privalo klientas.
vimo vadovo.
oversettelse.
go.
tência técnica.
tência técnica.
6/26 HHS 46-017562 Revision 29

Beam Quality Test

service.
! языке.
de servicio.
naturaleza.
handboken.
prevod.
46-017562 Revision 29 HHS 7/26

Beam Quality Test

Revision History
1 May 24, 1995 Note added to recording data. -
2 Apr. 30, 1996 Minor updates. -
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. -
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 -
Roentgen 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.
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. 30
16 May 5, 2010 Updated to modify Finalization section of REG0065 32
17 August 5, 2010 New update of REG0065 28
18 July 21, 2011 Update of REG0065 to introduce Innova IGS 520, 530, 540 28
19 September 26, 2011 Update of REG0065 to introduce Discovrey IGS 730 28
20 January 20, 2012 Update of REG0065 to introduce Innova IGS 620, 630 28
21 January 30, 2012 Update of REG0065 for Discovrey IGS 730 28
22 May 29, 2012 Update of REG0065 for Optima CL320i/CL323i 28
8/26 HHS 46-017562 Revision 29

Beam Quality Test

23 August 20, 2013 Update of REG0065 to introduce Discovery IGS 740 and 28
TM TM
change product name to Discovery IGS 730, Discovery IGS
740
24 September 4, 2013 Update of REG0065 to introduce Optima IGS320 28
25 September 4, 2014 Update of REG0065 to change product name to “InnovaTM IGS 28
620” and “InnovaTM IGS 630”
26 March 4, 2015 Update of REG0065 to introduce “Optima IGS 330 and change 28
product name to “Optima IGS 320”.
27 July 5, 2017 Update of REG0065 to introduce “InnovaTM IGS 5”, “InnovaTM 28
IGS 6”, “DiscoveryTM IGS 7” and “DiscoveryTM IGS 7 OR”.
28 January 2021 Updated of REG0065 to introduce "Allia™ IGS 7", "Allia™ IGS 7 28
OR", "Allia™ IGS Systems" and "Optima IGS Plus"
29 November 2021 Update of REG0065 to introduce "Allia™ IGS 3" and "Allia™ IGS 26
5".
46-017562 Revision 29 HHS 9/26

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 29 HHS 11/26

1
1 Beam Quality Test
1.1 Safety
X-Ray Protection
WARNING

CAUTION
AMERICAS W–622
P.O. BOX 414
46-017562 Revision 29 HHS 13/26

1.2 REG0065 - Beam Quality Test Beam Quality Test
codes.
1.2 REG0065 - Beam Quality Test


ments
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
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
14/26 HHS 46-017562 Revision 29

Beam Quality Test 1.2 REG0065 - Beam Quality Test
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- 1
ing Range (Kilo- kVp meters of Aluminum)** For Sys- meters of Aluminum)** For Sys-
Beam Quality Test

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
60 1.3 1.5
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 or
fore June 10th, 2006 in millime- After June 10th, 2006 in millimeters
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
46-017562 Revision 29 HHS 15/26

• 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.
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
• 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.
16/26 HHS 46-017562 Revision 29

Figure 1-1 Half Value Layer - Good Geometry
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.
• Probe not 12” from absorber.
• 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.
46-017562 Revision 29 HHS 17/26

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.
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
• 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.
18/26 HHS 46-017562 Revision 29

• 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 and Optima IGS 330, 1
set the techniques below (and click Submit button), center the probe while
Beam Quality Test

making exposures and collimate to probe volume by reducing the Collimator
LONG/LAT values (click Submit button to validate changes).
Table 1-4
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
Then, set the following technics (and click Submit button) for measurement phase:
Table 1-5
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
NOTE
Let current values to keep collimator settings.
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.
8. Compute the ratio (Dose with absorber over dose without absorber). Check the Table
1-6 on page 19 for action.
Table 1-6
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.
46-017562 Revision 29 HHS 19/26

• 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).

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)]
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 and Optima IGS 330, 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 1-8
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
20/26 HHS 46-017562 Revision 29

Beam Quality Test 1.3 REG0066 - Beam Quality Test - Graphical Method
• IMAGING REQT: DOSE RATIO < 0.57
Recording Data
Record the data (apply any corrective factor if required and check final results are within acceptance
1
criteria):
Beam Quality Test

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
1.3 REG0066 - Beam Quality Test - Graphical Method


ments
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
46-017562 Revision 29 HHS 21/26

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.
22/26 HHS 46-017562 Revision 29

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

46-017562 Revision 29 HHS 23/26

Buc 78530 FRANCE
HHS
Fluoro Systems Tests
46-017563
Revision 36
US English
WARNING
devices be used.
Language Policy

работа.
опасност.
害。
46-017563 Revision 36 HHS 3/38


priručnik.
jeho obsah.
či jiných rizik.
gevaren.
understood.
ohjeen.
4/38 HHS 46-017563 Revision 36


den zu haben.
kommen.
nem értelmezték.
い。
46-017563 Revision 36 HHS 5/38


시오.
privalo klientas.
vimo vadovo.
oversettelse.
go.
tência técnica.
tência técnica.
6/38 HHS 46-017563 Revision 36


service.
! языке.
de servicio.
naturaleza.
handboken.
prevod.
46-017563 Revision 36 HHS 7/38


Revision History
1 Apr. 30, 1996 Minor updates. -
users
3 Apr. 8, 1998 Revised Section 2 testing to reduce exposure rate. -
4 July 8, 1998 Added note regarding collimator shield design to Section 3. -
5 Nov. 24, 2000 Added Innova 2000 information. -
6 Nov. 15, 2001 Revised to incorporate changes made to Innova 2000. -
7 June 14, 2002 Revised for Precision 500D R&F System program. -
8 March 24, 2003 Added modification regarding Innova: ’Innova 2000/4100’ re- -
places ’Innova 2000’ in both Section 1 and Section 3.
10 October 17, 2003 Updated Section 3–6 (BUCge95105). -
11 April 23, 2004 Updated references for Innova 3100. Section 4, Tube Leak- -
age Radiation updated EURge08067. Section 3 updated
EURge01420
12 May 4, 2004 Updated procedure, Section 4-2 (meter set up) -
13 Jan 19, 2005 Updated for SPR EURge16987 (added mGy units along with -
Roentgen units) in pages 1, 2, 6, 7, 10, 11, 15, 16, and 17.
14 April 12, 2005 Updated to include Innova 2100–IQ information. -
15 February 2006 Tables 1 and 2 updated to correct unit of measure R/min -
and mGy/min. Added Innova 3100–IQ and Innova 4100–IQ
information
16 July 12, 2006 Updated 46–017563: tube leakage radiation suppression on -
INNOVA (SPR EURge53442).
17 July 20, 2007 • Added: Innova 2121–IQ and Innova 3131–IQ information -
• Updated: Section 2 and 3 (SPR EURge74619)
• Updated: Section 3 (SPR EURge74664)
18 October 9, 2007 • Updated: Sections 2 and 3 (SPR EURge76947) -
• Updated: Section 3 (SPR EURge 80436).
8/38 HHS 46-017563 Revision 36


19 Dec. 20, 2007 • Converted from Interleaf into e-CLS platform. 42
• Updated: Section 3 (SPR EURge 81110).
20 March 17, 2008 REG0068, REG0069 and REG0070 procedures updated with 44
new Victoreen tool
21 May 5, 2010 Updated to modify Finalization sections of REG0067 and 50
REG0069
22 August 5, 2010 New updates of REG0067 and REG0069 44
23 January 26, 2011 New updates of REG0069 44
24 March 18, 2011 REG0069 updated for alternate dosimeters 44
25 July 27, 2011 Update of REG0067 and REG0070 to introduce Innova IGS 520, 44
530, 540
26 September 26, 2011 Update of REG0067, REG0069 and REG0070 to introduce Dis- 44
covery IGS 730
27 January 20, 2012 Update of REG0067, REG0069 and REG0070 to introduce Inno- 44
va IGS 620, 630
28 January 30, 2012 Update of REG0067and REG0069 for Discovery IGS 730 46
29 May 29, 2012 Update of REG0067, REG0069 and REG0070 for Optima 46
CL320i/CL323i
30 August 20, 2013 Update of REG0067, REG0069 and REG0070 to introduce Dis- 46
covery IGS 740 and change product name to DiscoveryTM IGS
730, DiscoveryTM IGS 740
31 September 4, 2013 Update of REG0067, REG0069 and REG0070 to introduce Opti- 46
ma IGS320.
32 September 4, 2014 Update of REG0067, REG0069 and REG0070 to change product 42
name to “InnovaTM IGS 620” and “InnovaTM IGS 630”
33 March 4, 2015 Update of REG0067, REG0069 and REG0070 to introduce “Op- 42
tima IGS 330” and change product name to “Optima IGS 320".
34 July 5, 2017 Update of REG0067, REG0069 and REG0070 to introduce “In- 44
novaTM IGS 5”, “InnovaTM IGS 6”, “DiscoveryTM IGS 7” and “Dis-
coveryTM IGS 7 OR”.
35 January 2021 Updated of REG0067, REG0069 and REG0070 to introduce "Al- 44
lia™ IGS 7", "Allia™ IGS 7 OR", "Allia™ IGS Systems" and "Optima
IGS Plus"
36 November 2021 Update of REG0067, REG0069 and REG0070 to introduce "Al- 38
lia™ IGS 3" and "Allia™ IGS 5".
46-017563 Revision 36 HHS 9/38

Fluoro Systems Tests Contents
Contents
1 Fluoro Systems Tests ........................................................................................................................13
1.1 Safety ............................................................................................................................................................................................. 13
1.2 REG0067 - Fluoro Entrance Exposure Rate ................................................................................................................... 14
1.3 REG0068 - Primary Barrier Transmission....................................................................................................................... 19
1.4 REG0069 - Primary Barrier Transmission (20, 30 and 40 cm Detector)............................................................ 25
1.5 REG0070 - Tube Leakage Radiation.................................................................................................................................. 31
1.6 Fluoro Interlocks........................................................................................................................................................................ 35
46-017563 Revision 36 HHS 11/38

1
1 Fluoro Systems Tests
1.1 Safety
X-Ray Protection
WARNING

CAUTION
AMERICAS W–622
P.O. BOX 414
46-017563 Revision 36 HHS 13/38

1.2 REG0067 - Fluoro Entrance Exposure Rate Fluoro Systems Tests
codes.
1.2 REG0067 - Fluoro Entrance Exposure Rate

All fluoroscopic image receptors, at installation, repair, preventive maintenance, or replacement of
X–ray tube or HV transformer.

ments
Requirements
1. See Table 1-2 Maximum Exposure Rates on page 14. Note that, in practice, the rejection limits
for entrance exposure rate must be somewhat less than shown in Table 1-2 Maximum Exposure
Rates on page 14 due to R–meter calibration accuracy. See Table 1-3 Rejection Limits Based on
Meter Calibration Accuracy on page 15.
Table 1-2 Maximum Exposure Rates
Mode Systems manufactured after Systems manufactured be-

5/95 fore 5/95
Fluoro, System W/O Hi-level control 87.6 mGy/min (10 R/min, auto or 87.6 mGy/min (10 R/min, auto
manual) or manual)
Fluoro, System W Hi-level control and 175 mGy/min (20 R/min, auto or No limit
Hi-level is active manual)
Fluoro, System W Hi-level control and 87.6 mGy/min (10 R/min, auto or 43.8 mGy/min (5 R/min, auto or
Hi-level is not active manual) manual)
Recording Modes No limit No limit
14/38 HHS 46-017563 Revision 36

Fluoro Systems Tests 1.2 REG0067 - Fluoro Entrance Exposure Rate
NOTE
The Hi–Level control must provide a signal to the operator, indicating that Hi–Level
is employed, and the system must revert back to normal operation as soon as the
Hi–Level exposure is terminated, i.e. as soon as the operator releases the exposure
switch. 1
Table 1-3 Rejection Limits Based on Meter Calibration Accuracy

Meter Calibration Accuracy Rejection Limits
For 43.8 mGy/min Max. For 87.6 mGy/min Max.
(for 5 R/min Max.) (for 10 R/min Max.)
+/-5% 41.2 mGy/min (4.7 R/min) 83.2 mGy/min (9.5 R/min)
+/-10% 39.5 mGy/min (4.5 R/min) 78.84 mGy/min (9.0 R/min)
Procedure
1. Review Chapter RADIATION INSTRUMENTS of 46–017560, HHS TOOLS for use of radiation
instruments.
2. Position equipment as shown in the following illustrations as applicable.
Figure 1-1 Test set-up - undertable source, test 5-1, Fluoro entrance exposure rate
NOTE
The attenuation block assembly is used only as a convenient method of supporting
the lead blocker. Any other method of protecting the system from radiation and light
signal overload is acceptable.
46-017563 Revision 36 HHS 15/38

Figure 1-2 Test set-up - overtable source, Fluoro entrance exposure rate
Figure 1-3 Test set-up - lateral source, Fluoro entrance exposure rate
NOTE
*These relations must be maintained at all times. Within these restrictions, make
measurements at min and max SID.
NOTE
Applies to archaic systems with independent tube and intensifier suspensions, used
with beam horizontal only, and without SID compensation.
16/38 HHS 46-017563 Revision 36

Fluoro Systems Tests 1.2 REG0067 - Fluoro Entrance Exposure Rate
Figure 1-4 Test set-up C-arm or LU-arm Fluoro entrance exposure rate

NOTE
The above procedure is applicable to Innova 2000, Innova 2100-IQ/2121-IQ, Innova
3100/3100-IQ/3131-IQ, Innova 4100/4100-IQ, 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
and Optima IGS 330, the Lateral Intensifier being replaced by the Digital Detector.
NOTE
Collimator is wide open, probe is centered in field, beam covers entire active volume
of probe. Make measurements at min and max SID but note that the 12” (30 cm)
distance from the probe to the intensifier must be maintained at all times. If the
intensifier is moved away from the table, then the probe must be repositioned.
3. Select collimator mode so that beam is opened to its maximum field size.
4. Position the probe so that the probe active volume is at the center of the primary beam, and the
entire active volume is within the primary beam.
5. Block radiation input to image intensifier with lead port blocker.
NOTE
For Innova 2000, Innova 2100-IQ/2121-IQ, Innova 3100/3100-IQ/3131-IQ, Innova
4100/4100-IQ, 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 and Optima IGS 330, do NOT insert
the Lead Port Blocker in place of the antiscatter device, but in front of the panel –
Lead Blocker presence inhibits X-ray in application.
46-017563 Revision 36 HHS 17/38

6. Make a series of exposures in MANUAL mode, maximum mA, covering all kVps in 20 kVp steps.
Verify actual and indicated kVp.
NOTE
For Precision 500D, do this test in place of Step 6. Select Patient Protocols that
approximate the following kVps. The system will drive to maximum mA due to beam
loading. Skip Step 7 and Step 8.
Table 1-4
kVp Measured patient dose mGy/min (R/min)

60
80
80
120
120
NOTE
Step 6, is not applicable to Innova 2000, Innova 2100-IQ/2121-IQ, Innova 3100/3100-
IQ/3131-IQ, Innova 4100/4100-IQ, 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 and Optima IGS 330: no
MANUAL mode.
7. Repeat the procedure in the auto brightness control mode. The system shall be at its maximum
kVp (override) and mA output.
NOTE
CL320i/CL323i, Optima IGS Plus, Optima IGS 320 and Optima IGS 330, a previous
X–ray run must be made, in order to place optimized spectral filter. Failure to do
this will result in lower Dose Rates vs. expected ones. Make these measurements at
minimum and maximum SID, at 30 fps.
8. If the limits are exceeded, then the system must be readjusted in accordance with the generator
service manual. In some cases entrance exposure rate adjustments are described in the image
intensifier service manual.
NOTE
CL320i/CL323i, Optima IGS Plus, Optima IGS 320 and Optima IGS 330, the mR/mAs
calibration unit and the Fluoro Taper calibration unit has to be run in case of limits
exceeded.
18/38 HHS 46-017563 Revision 36

Fluoro Systems Tests 1.3 REG0068 - Primary Barrier Transmission
Problem Possible Cause 1

High Fluoro Insufficient filtration (HVL too low)

Entrance Probe not centered
Exposure Rate Incorrect set-up
Finalization
1.3 REG0068 - Primary Barrier Transmission

All fluoroscopic imaging assemblies, at installation, repair, or preventive maintenance.

ments

Victoreen 470 A sur- 1 - -
vey meter
or Victoreen 451B 1 - 5270475 -
survey meter

The exposure rate due to transmis- - -
sion through the barrier plus any
resulting from image intensifier high-
voltage shall not exceed 17.56 μGy/h
(2.0 mR/hr) for each 8.76 mGy/min
(1.0 R/min) input exposure rate when
the following three conditions are
satisfied simultaneously:
- Max fluoro kVp is selected - -
- Attenuation block assembly is in - -
useful beam
- Transmitted radiation is measured - -
at 10 cm from any accessible surface
of the fluoro imaging assembly be-
yond the plane of the image receptor
(image intensifier)
Rejection limits: 13.1 μGy/h (1.5 - -
mR/hr) for each 8.76 mGy/min (1.0
R/min) input exposure rate.
46-017563 Revision 36 HHS 19/38

1.3 REG0068 - Primary Barrier Transmission Fluoro Systems Tests
Table 1-8 Required conditions (Table continued)

Test data may be entered into the 46–017566 HHS Forms, completing -
Laptop 3382 spreadsheet program, the FDA 2579 and GE data record
or if this is not available, it may be forms
recorded in Form 3382.
Procedure
NOTE
This test is intended to measure the non–diagnostic radiation coming directly from the
sides of the Image Intensifier (II).
1. Ensure that the Fluoro Entrance Exposure Rate Test has been completed. Step 9.b (if using
Victoreen 470A survey meter) or Step 10.b (if using Victoreen 451B survey meter) will be
facilitated if the Exposure Rate Test setup is still in place.
Figure 1-5 Test Set-up - Undertable Source, Primary Barrier Transmission
2. Remove all covers enclosing the Image Intensifier (II).

3. Remove the lead curtain from the SFD.
4. Remove any movable grids and compression devices from the useful beam.
5. Remove lead port blocker.
6. Select AUTO collimator mode so that beam is opened to its maximum field size.
NOTE
Precision 500D select maximum FOV (mag Ø) and open collimator blades to
maximum.
20/38 HHS 46-017563 Revision 36

7. Place the 1–1/2 inch (3.8 cm) width attenuation block assembly with legs in the beam path, in
the area normally occupied by the patient.
8. Select Patient Protocols that provide maximum fluoro kVp, and mA to provide a tabletop
(patient entrance dose) exposure rate of 8.7 mGy/min (1.0 R/min) or any multiple (i.e. 2, 3, etc.)
1
NOTE

Prior to Revision 3 of this Direction this instruction set fluoro mA to maximum, which
would overload the image system and thus require the electronics be protected.
By setting mA for 8.76 mGy/min (1.0 R/min) at the tabletop, the image system
can operate without overload and no special precautions are needed. This sets the
rejection limit at 13.1 μGy/h (1.5 mR/hr).
9. Using Victoreen 470A
a. Set up the Victoreen Model 470A Panoramic Radiation Survey Meter as follows:
(As a prerequisite, the meter must pass the battery check.)
Figure 1-6 Victoreen 470A Survey Meter
You MUST use the meter with the cap in place on the front of the meter, AND with the disk
shaped cover affixed to end of meter cap. Position the meter for ease of reading, since aim
is not significant.
i. Use the meter with the cap in place on the front of the meter, and with the disk
shaped cover affixed to the end of the meter cap, per Figure 1-6 Victoreen 470A Survey
Meter on page 21.
ii. Set the meter Function switch to mR/hr and the Range switch to 3, to get a scale of 3
mR/hr (or equivalent with Gray unit).
iii. Let the meter warm up, and zero the meter.
b. Make exposure and scan with the front of the cap of the Victoreen meter 10 cm from
surface of the primary protective barrier (spot–film device, film holder, tower, image
intensifier, etc.). Refer to Figure 1-5 Test Set-up - Undertable Source, Primary Barrier
Transmission on page 20, Figure 1-10 Test Set-up - Overtable Lateral Source or C-arm, or
LU arm, Primary Barrier Transmission on page 23 and Figure 1-11 Test Set-up - Overtable
Source, Primary Barrier Transmission on page 24 as appropriate for the equipment.
NOTE
When making readings beyond the surface of the image receptor, be careful
that the radiation that is being read is not air scatter. This will give a false
reading and will probably be in excess of the limit. See Figure 1-5 Test Set-
up - Undertable Source, Primary Barrier Transmission on page 20 , Figure
1-10 Test Set-up - Overtable Lateral Source or C-arm, or LU arm, Primary Barrier
Transmission on page 23 and Figure 1-11 Test Set-up - Overtable Source,
46-017563 Revision 36 HHS 21/38

Primary Barrier Transmission on page 24 for typical placement of air scatter

shield.
10. Using Victoreen 451B
a. Victoreen 451B Radiation Survey Meter is currently replacing the Victoreen 470A. This tool
is simpler of use than Victoreen 470A but requires also specific handling:
Figure 1-7 Victoreen 451B Survey Meter
You MUST use the meter with the slide open as shown below, to see the circular metallic
entrance window of the survey meter chamber. The survey meter window shall be hold
perpendicular to the X-ray beam direction to be measured.
Figure 1-8
i. Set ON the meter with ON/OFF button: the display indicates HI, then low batt Freeze
then goes automatically to dose rate mode in mR/h. If you want to select dose
integrated mode, press the left button MODE and press again to select dose rate.
22/38 HHS 46-017563 Revision 36

Figure 1-9

ii. Wait for 4 minutes for a complete warm up (that operation is critical as doses
measured behind primary barrier are very low).
iii. Scaling is automatic (no selection required).
b. Make exposure and scan with the circular metallic entrance window of the Victoreen 451B
meter 10 cm from surface of the primary protective barrier (spot–film device, film holder,
tower, image intensifier, etc.). Refer to the following illustrations and Figure 1-5 Test Set-up
- Undertable Source, Primary Barrier Transmission on page 20, as appropriate for the
equipment.
Figure 1-10 Test Set-up - Overtable Lateral Source or C-arm, or LU arm, Primary Barrier
Transmission
46-017563 Revision 36 HHS 23/38

Figure 1-11 Test Set-up - Overtable Source, Primary Barrier Transmission
NOTE
When making readings beyond the surface of the image receptor, be careful
that the radiation that is being read is not air scatter. This will give a false
reading and will probably be in excess of the limit. See Figure 1-5 Test
Set-up - Undertable Source, Primary Barrier Transmission on page 20,Figure
1-10 Test Set-up - Overtable Lateral Source or C-arm, or LU arm, Primary Barrier
Transmission on page 23 andFigure 1-11 Test Set-up - Overtable Source, Primary
Barrier Transmission on page 24 for typical placement of air scatter shield.
Record Data
1. On Data Form F3382, record the maximum readings and show the location on one of the
diagrams.
NOTE
For the 40 cm intensifier, you must use the 12” attenuation block and not the old 8
inch blocks.
2. If the leakage levels determined above are in excess of allowable, then evaluation must be made
for proper lead placement in the primary barrier. If problem cannot be resolved, then consult
your service supervisor and/or Region Support Engineer.
3. Be sure to re-install the lead curtain at the SFD.
NOTE
Any portion of the SFD that is below the input plane of the Image Intensifier is not to
be included in the measurement, e.g., do not scan the cassette slot.
Finalization
24/38 HHS 46-017563 Revision 36

Fluoro Systems Tests 1.4 REG0069 - Primary Barrier Transmission (20, 30 and 40 cm Detector)
1.4 REG0069 - Primary Barrier Transmission (20, 30

and 40 cm Detector) 1

ments

HHS suitcase with 38 1 system with 20 cm 5245018 -
mm AL attenuator detector
block and lead scat-
ter shield. Note: if
this tool is not availa-
ble, it is also possible
to use the suitcase
#2408517 designed
for system with a 30
cm detector.
mm AL attenuator detector
block and lead scat-
ter shield
mm with Al attenu- detector
ator block and lead
scatter shield and
probe mechanical in-
terface
Standard Service En- 1 - - -
gineer's toolkit.
The MDH 2025/2026 1 - - -
(or equivalent) with
6cc probe for meas-
uring the input expo-
sure rate 1.0 R/min
(8.76 mGy/min)
Survey meter Vic- 1 - - -
toreen 470A or
451B (or equivalent
in range and ac-
curacy) for the ac-
tual primary barrier
transmission meas-
urement.
Table 1-11 Safety
WARNING
X-Ray
46-017563 Revision 36 HHS 25/38

1.4 REG0069 - Primary Barrier Transmission (20, 30 and 40 cm Detector) Fluoro Systems Tests

The exposure rates due to transmis- - -
sion through the barrier plus any
resulting from image receptor high
voltage shall not exceed 17.5 μGy/h
(2.0 mR/hr) for each 8.76 mGy/min
(1 R/min) input exposure rate as per
government regulation requirement.
Considering the measurement accu-
racy, the rejection limit for the test
will be 13.1 μGy/h (1.5 mR/hr) for
each 8.76 mGy/min (1 R/min) input
exposure rate.
Max Fluoro kVp - -
Attenuation block assembly is in - -
useful beam
Transmitted radiation is measured at - -
10 cm from any accessible surface of
the detector beyond the plane of the
image receptor
Actual dose rate at 30 cm from De- - -
tector
The purpose of this section is to check the primary barrier transmission on systems; this test is
intended to measure the non diagnostic radiation beyond the Image Receptor plan of the Digital
Detector.
This procedure is applicable to systems at Installation and in case of Detector replacement.
NOTE
(For US only)
This test is mandatory only for Innova 2000 systems but not 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 320 and Optima IGS 330.
Discovery™ IGS 730, Discovery™ IGS 740 systems or Discovery™ IGS 7 and Discovery™
IGS 7 OR systems are also named DiscoveryTM IGS Systems. The procedure is applicable
indifferently to Discovery™ IGS 730 or Discovery™ IGS 740, Discovery™ IGS 7, Discovery™
IGS 7 OR.
Gantry Preparation
Case Innova 2000 without capacitive sensors

1. Tilt to 90°C the Detector anticollision device and remove the grid support (refer to Job Card
DR17–097, section #5.7 INNOVA 2000 Service Manual CD).
2. Move the gantry to the position: L = 0, C = 0, P = + 90°C, SID min.
26/38 HHS 46-017563 Revision 36

Case Innova 2000 with capacitive sensors

1. Remove the antenna cover and the switch ring and the grid support (refer to Job Card DR17–
220, INNOVA 2000 Service Manual DVD).
1
2. Move the gantry to the position: L = 0, C = 0, P= –90°C (detector on left lateral side), SID min.

Case system with 20 cm detector
1. (For Innova) Remove the switch ring (DR0349 of Service Manual DVD), the soft cover and the
antenna cover (DR0566/DR0578) and the grid support (DR0373).
2. (For Optima IGS Plus and Optima IGS 320) Remove the switch ring (DR1004 of Service Manual
DVD), the soft cover, the antenna cover (DR1103/DR1003) and the grid support (DR1002).
3. (For Allia™ IGS 5) Remove the Elevator covers (DR1249 of Service manual DVD), the Detector Top
covers (DR1337), the Detector Bottom cover (DR1334), the anticollision (DR1336) and the grid
frame (DR1338).
4. Move the gantry to the position: L = 0, C = 0, P = –90°C , SID min.

1. (For Innova and Discovery™ IGS Systems) Remove the detector covers (DR0564/DR0577 Service
manual DVD), the switch ring (DR0326), the anticollision (DR0329) and the grid sliders (DR0324).
2. (For Optima CL320i/CL323i, Optima IGS Plus and Optima IGS 330) Remove the detector covers
(DR0834/DR0823 Service manual DVD), the switch ring (DR0825), the anticollision (DR0824) and
the grid sliders (DR0826).
3. (For Allia™ IGS Systems and Allia™ IGS 3) Remove the Elevator covers (DR1249 of Service manual
DVD), the Detector Top covers (DR1251), the Detector Bottom cover (DR1307 or DR1308), the
anticollision (DR0329) and the grid sliders (DR0324).

1. (For Innova and Discovery™ IGS Systems) Remove the detector covers (DR0245 Service manual
DVD), the switch ring and the collision sensor (DR0255), the left grid slider (DR0254).
2. (For Allia™ IGS Systems) Remove the Elevator covers (DR1249 of Service manual DVD), the
Detector Top covers (DR1309), the Detector Bottom cover (DR1310), and the left grid slider
(DR0254).
Case system with 20 cm detector (biplane)

1. Frontal: Remove the switch ring (DR0349 Innova Service manual DVD), the antenna covers
(DR0566) the anticollision (DR0372) and the grid sliders (DR0373).
2. Lateral: Remove the antenna covers (DR0358 Innova Service manual DVD) the anticollision
(DR0543) and the grid sliders (DR0544).
Case system with 30 cm detector (biplane)

1. Frontal: Remove the switch ring (DR0326 Innova Service manual DVD), the anticollision
(DR0564) and the grid sliders (DR0324).
2. Lateral: Remove the soft covers (DR0539 Innova Service manual DVD) the anticollision (DR0546)
and the grid sliders (DR0548).
46-017563 Revision 36 HHS 27/38
Tool Installation
Figure 1-12 Test Set-up - C-Arm, Primary Barrier Transmission
3.8 cm attenuation block assembly installation

1. Place the 6 cc dosimeter probe on its stand at 30 cm from the detector surface entrance plan.
2. Place the 38 mm attenuation block assembly in the X–ray beam on the table between
dosimeter probe and detector (refer to Figure 1-12 Test Set-up - C-Arm, Primary Barrier
Transmission on page 28).
3. Use the plastic cylinder gauge to position the output face of the block at 15.5 cm from detector.
4. Center the attenuation block to the detector face (Horizontal and vertical ways) by moving the
table (refer to Figure 1-12 Test Set-up - C-Arm, Primary Barrier Transmission on page 28).
NOTE
A mechanical interface allowing adapting the probe to the attenuator block is
delivered on some systems (systems with 30 and 40 cm detector). This adaptation
fixes per design the distance (10.7 cm) between the probe and the attenuator block.
Scatter lead shield

1. Install the lead shield around the detector in the different positions as shown on the following
illustration.
Note that using the HHS suitcase for a 30 cm detector on a 20 cm detector it will be required to
move the shield from measurement to measurement around the detector.
28/38 HHS 46-017563 Revision 36

Figure 1-13 Scatter Lead Shield Positions (View behind the detector)

2. The Figure 1-13 Scatter Lead Shield Positions (View behind the detector) on page 29 shows a
detector 20 cm using the HHS suitcase for 30 cm detectors. In that case the scatter lead shield
is 11 cm larger than the detector.
In all the other cases, the scatter lead shield fits with the detector size.
Measurement preparation for Innova 2000

1. Select HHS9 in X 220 F unit in the SUIF Browser (Service Application).
2. Perform Fluoro and check on the image that the collimator is opened to MAX FOV.
3. Check that the 6 cc dosimeter probe is centered in the image and the distance from the
dosimeter probe center to the detector surface entrance is 30 cm (refer to Figure 1-12 Test
Set-up - C-Arm, Primary Barrier Transmission on page 28)
4. Make an exposure and read the actual dose rate. Record the data (apply any corrective factor if
required and check final results are within acceptance criteria).
5. Select HHS9, Next button for manual control.
6. Select: 120 kV, 0.015 mAs, 7.5 ms PW, 0.6 Focal Spot, no spectral filter and (x,y) collimator
opening size (x,y are calculated values corresponding to blade position in maximum collimator
opening when the blades are calibrated “slightly visible” per Po11 instruction). This value is
about 1950x1950.
7. Make an exposure and adjust mAs in the Fluoro Acquisition screen in order to get 1.0 R/min +/-
20%. Record the data (apply any corrective factor if required and check final results are within
8. Read the mA from the console to get the value (Do not capture the mA from Fluoro 30 fps
screen because it displays the mA peak instead of average values).
46-017563 Revision 36 HHS 29/38

NOTE
The correction factor is calculated and displayed in the spreadsheet once the
parameters captured: [Correction factor] = [dose reading at 30 cm] divided by [1.0
R/min].
10. Set up the Survey meter set up:
a. Set up the Victoreen Model 470A Panoramic Radiation Survey Meter, or the Victoreen 451B
Radiation Survey Meter: (Inspire from Victoreen tool to make measurement with any other
equivalent dosimeter in range and accuracy).
b. Run the battery check.
c. You must use the meter with the cap in place on the front of the meter, and with the disk
shaped cover affixed to the end of the meter cap.
d. Set the meter function switch to mR/hr and the range switch to 3, to get a scale of 3 mR/hr.
e. Let the meter warm up, and zero the meter.
Measurement preparation for Innova 2100-IQ / 3100/3100-IQ / 4100/4100-IQ / 2121-IQ /

3131-IQ, 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 and Optima IGS 330
1. Select the unit HHS X220 generic in the SUIF Browser (Service Application).
2. Select: 120 kV, no spectral filter, 1 mA, 7.5 ms PW, 30 fps and (x, y) collimator opening size (x,y
are calculated values corresponding to blade position in maximum collimator opening when the
blades are calibrated slightly visible per Po11 instruction). This value is about 1950x1950.
3. Read the mA from the Status bar at the bottom of the X220 Calibration page.
4. Perform Fluoro and check on the image that the collimator is opened to MAX FOV.
5. Check that the 6 cc dosimeter probe is centered in the image and the distance from the
dosimeter probe center to the detector surface entrance is 30 cm (refer to Figure 1-12 Test
Set-up - C-Arm, Primary Barrier Transmission on page 28)
6. Make an exposure and adjust mA in the X220 tool in order to get 1.0 R/min +/- 20% (8.76
mGy/min +/- 20%). Record the data (apply any corrective factor if required and check final
results are within acceptance criteria).
7. Compute the mA and kV with correction factor as following:
[Correction factor] = [dose reading at 30 cm] divided by [1.0 R/min].
8. Set up the Survey meter set up
a. Set up the Victoreen Model 470A Panoramic Radiation Survey Meter, or the Victoreen 451B
Radiation Survey Meter: (Inspire from Victoreen tool to make measurement with any other
equivalent dosimeter in range and accuracy).
b. Run the battery check.
c. You must use the meter with the cap in place on the front of the meter, and with the disk
shaped cover affixed to the end of the meter cap.
d. Set the meter function switch to mR/hr and the range switch to 3, to get a scale of 3 mR/hr
(or equivalent with Gray unit).
e. Let the meter warm up, and zero the meter.
30/38 HHS 46-017563 Revision 36

Fluoro Systems Tests 1.5 REG0070 - Tube Leakage Radiation
Measurements
For each scan measurement area illustrated below run the following operations
NOTE 1
When making readings beyond the surface of the image receptor, be careful that the

radiation that is being read is not air scatter. This will give a false reading and will probably
be in excess of the limit. See Figure 1-13 Scatter Lead Shield Positions (View behind the
detector) on page 29 depending on your system for typical placement of air scatter shield.
1. Run a Fluoro acquisition, scan with the front of the cap of the Victoreen 470A meter, or with
the circular metallic entrance window of Victoreen 451B meter, at 10 cm from the external
surface of the detector and capture the maximum dose measured during the scan. Repeat these
operations for each scan surface illustrated (refer to Figure 1-13 Scatter Lead Shield Positions
(View behind the detector) on page 29).
NOTE
For Innova 2000 and systems with 20 cm detector, you must add an 11 cm
spacer between the detector and the scatter lead shield to hold in the positions
4 and 5 (refer to Figure 1-13 Scatter Lead Shield Positions (View behind the
detector) on page 29).
2. Select the highest value among the five scan doses captured and record the data (apply any
corrective factor if required and check final results are within acceptance criteria).
Reject criteria
[Corrected value] = [measured value] divided by the [Correction factor]. Corrected value shall be
lower than 1.5 mR/hr (13.1 μGy/h).
Finalization
1.5 REG0070 - Tube Leakage Radiation


ments

Victoreen 470 A sur- 1 - -
vey meter
or Victoreen 451B 1 - 5270475 -
survey meter
46-017563 Revision 36 HHS 31/38

1.5 REG0070 - Tube Leakage Radiation Fluoro Systems Tests

When the X-Ray tube is operated at - -
its maximum leakage technique fac-
tors, the leakage radiation from the
diagnostic source assembly meas-
ured at a distance of one meter in
any direction from the source shall
not exceed 0.876 mGy/h (100 mR/hr).
Rejection limit: 0.657 mGy/h (75 mR/ - -
hr).
On all tables verify that front and - -
rear lead collimator shields are in
place.
On any table where the source is - -
on a moving carriage or the table is
capable of being tilted, the measure-
ment shall be made with the diag-
nostic source assembly at both ends
of the table, and with the table tilted.
On tables with elevating mecha- - -
nisms, the measurements shall be
made with the table elevated to its
maximum.
Diagnostic source assemblies that - -
are tested in certified tables shall be
checked with the collimator blades
open. (Diagnostic source assemblies
installed or re-installed in un-certi-
fied tables shall be checked with the
collimator blades closed. This blocks
off the collimator and limits the tests
to the tube casing and collimator.)
Test data may be entered into the 46–017566 HHS Forms, completing -
Laptop 3382 spreadsheet program, the FDA 2579 and GE data record
or if this is not available, it may be forms
recorded in Form 3382.
All X-Ray tables that have a certified tube unit mounted in a table, at installation or replacement of
tube unit.
NOTE
Due to an improved collimator shield design, the undertable leakage test is not required
for the following systems:
• Legacy III
• All other Legacy and SFX systems manufactured after October 1, 1998.
NOTE
This test is not applicable to Innova 2100-IQ, 2121-IQ, 3100, 3100-IQ, 3131-IQ,
4100, 4100-IQ, Innova IGS 520, 530, 540, Innova™ IGS 5, Allia™ IGS 3, Allia™ IGS 5,
Innova™ IGS 620, IInnova™ 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 and Optima IGS 330.
32/38 HHS 46-017563 Revision 36

Fluoro Systems Tests 1.5 REG0070 - Tube Leakage Radiation
Procedure
NOTE
Use the sketches in F3382 as an aid in recording rough data. 1
1. Set up test conditions as described in the following table. Select maximum fluoro kVp and

corresponding mA. If leakage technique factor is beyond equipment setup limitations, then elect
maximum mA.
Table 1-16 Leakage Technique Factors (L.T.F.)
Tube Unit L.T.F. @ 125 kVp L.T.F. @ 120 kVp Max. Cont. Rating (for Ref. only)
MXR 75 4.6 mA 5.0 mA 150 kVp @ 2 mA
HRT 4.0 mA 4.5 mA 130 kVp @ 3.5 mA
MXR 100 FL 11.0 mA 12.0 mA 150 kVp @ 5.0 mA
MXR 100 RAD 9.3 mA 10.0 mA 150 kVp @ 4 mA
MXR 125 11.0 mA 12.0 mA 150 kVp @ 5.0 mA
MXR 135 9.9 mA 10.3 mA 130 kVp @ 9.5 mA
NOTE
GEMS-E - Refer to manufacturers tube rating spec
2. Place PORT BLOCK on top of collimator assembly. If table is to be tilted, secure PORT BLOCK in
place with tape.
Figure 1-14 Test Set-up – Undertable Leakage
NOTE
As a prerequisite, the meter must have a calibration sticker that is not past due, and
the meter must pass its battery check.
3. Using Victoreen 470A: set up the Victoreen Model 470A Panoramic Radiation Survey Meter as
follows:
46-017563 Revision 36 HHS 33/38

1.5 REG0070 - Tube Leakage Radiation Fluoro Systems Tests
a. You MUST use the meter with the cap in place on the front of the meter with the disk
shaped cover affixed to the end of the meter cap per the following illustration.
Figure 1-15 Victoreen 470A Survey Meter
b. Set the meter function switch to mR/hr and the range switch to 10, to get a scale of 10
mR/hr.
c. Let the meter warm-up, and then zero the meter.
4. Using Victoreen 451B: Victoreen 451B Radiation Survey Meter is currently replacing the
Victoreen 470A. This tool is simpler of use than Victoreen 470A but requires also specific
handling.
a. You MUST use the meter with the slide open as shown below, to see the circular metallic
entrance window of the survey meter chamber. The survey meter window shall be hold
perpendicular to the X-ray beam direction to be measured.
Figure 1-16 Victoreen 451B Survey Meter
34/38 HHS 46-017563 Revision 36

Fluoro Systems Tests 1.6 Fluoro Interlocks
b. Set ON the meter with ON/OFF button: the display indicates HI, then low batt Freeze then
goes automatically to dose rate mode in mR/h. If you want to select dose integrated mode,
press the left button MODE and press again to select dose rate.
Figure 1-17
1

c. Wait for 4 minutes for a complete warm up (that operation is critical as doses measured
behind primary barrier are very low). Scaling is automatic (no selection required).
5. Energize tube unit and bring up to leakage technique factors in accordance with accepted
warm-up procedures.
6. The survey is performed by making measurements in contact with table (to find hot spots) and
again at 1 meter from the source. (When diagnostic source assembly is on a movable carriage
under the table, measurements are made with the source assembly at each end of the table.)
a. Scan the surface of the table for maximum meter readings.
b. Repeat all of the measurements with the survey meter located 1 meter (39 inches) from the
source.
NOTE
This distance is measured from the focal spot. For example, the table top of the
Monitrol 90 is 18 inches (46 cm) from the focal spot, and a distance of 1 meter
from the source would be 21 inches (53 cm) above the table top.
7. If maximum leakage at 1 meter is in excess of 0.657 mGy/h (75 mR/hr), further evaluation is
required. First check to see that all required structural barriers are installed per installation
directions. If this does not correct the problem, contact Region Support Engineer.
8. Record data on Form 3382.
Finalization
1.6 Fluoro Interlocks

Perform this test as last fluoro test.
Application
All fluoroscopic imaging assemblies where the primary protective barrier is removable without tools.
At installation and periodic maintenance check.
46-017563 Revision 36 HHS 35/38

1.6 Fluoro Interlocks Fluoro Systems Tests
Requirement
Interlock shall be provided to prevent X-ray exposure unless the barrier (image intensifier) is in
position to intercept the entire useful beam.
Procedure
No X-ray should be possible when spot-film device is not in forward, locked position.
In the case of a vascular image intensifier, attempt to make exposures. No X-ray should be possible
when the image intensifier is not aligned over the tube unit in the table.
Record Data
Confirm test results in F3382.
WARNING
TO ELIMINATE THE POSSIBILITY OF ACCIDENTAL RADIATION EXPOSURE, MAKE

CERTAIN THAT THE INTERLOCK IS FUNCTIONAL FOLLOWING ANY SERVICE.
NOTE
Check that the interlock switch is firmly mounted. If necessary, tighten screws on use
Loctite. Failure of the switch to prevent accidental exposure is an automatic FDA non-
compliance.
36/38 HHS 46-017563 Revision 36

Buc 78530 FRANCE
HHS
Collimator Tests
46-017564
Revision 28
US English
Collimator Tests
WARNING
devices be used.
Language Policy

работа.
опасност.
害。
46-017564 Revision 28 HHS 3/76

Collimator Tests

priručnik.
jeho obsah.
či jiných rizik.
gevaren.
understood.
ohjeen.
4/76 HHS 46-017564 Revision 28

Collimator Tests

den zu haben.
kommen.
nem értelmezték.
い。
46-017564 Revision 28 HHS 5/76

Collimator Tests

시오.
privalo klientas.
vimo vadovo.
oversettelse.
go.
tência técnica.
tência técnica.
6/76 HHS 46-017564 Revision 28

Collimator Tests

service.
! языке.
de servicio.
naturaleza.
handboken.
prevod.
46-017564 Revision 28 HHS 7/76

Collimator Tests

Revision History
2 Dec. 1, 1997 Added note referencing form 3382. Added test procedure for -
Digital Filmless X-ray systems. Resolved CQA 972558, 972559
and 974912.
3 June 14, 2002 Revised for Precision 500D R&F System program. -
5 April 23, 2004 Sections 5 and 8 updated for INNOVA 3100 for M4. -
EURge01420
6 May 12, 2005 Updated to include Innova 2100-IQ information. -
7 February 15, 2006 Updated for Innova 3100-IQ and 4100-IQ -
8 July 20, 2007 Added: Innova 2121-IQ and Innova 3131-IQ information. -
Added Siemens collimator voltage (PQR 13107847).
Section 8 (Fluoro Collimator to image Intensifier): procedure
updated (EURge75616 and EURge76755).
9 Dec. 20, 2007 Conversion from Interleaf into e-CLS Platform -
10 January 25, 2008 Updated per SPR EURge86024. 70
11 May 9, 2008 Updated to add Chapter 2 content. 72
12 November 10, 2008 Chapter 9 updated for collimator alignment procedure (SPR 74
EURge95590)
13 February 12, 2010 Chapter 9, REG0086 - Fluoro Collimator to Image Intensifier 76
Test updated (SPR INTge09620)
14 May 5, 2010 Updated to modify Finalization section of REG0086 76
15 August 5, 2010 New update of REG0086 70
16 July 27, 2011 Update of REG0075 and REG0086 to introduce Innova IGS 520, 72
530, 540
17 September 26, 2011 Update of REG0075 and REG0086 to introduce Discovery IGS 72
730
18 January 20, 2012 Update of REG0075 and REG0086 to introduce Innova IGS 620, 72
630
8/76 HHS 46-017564 Revision 28

Collimator Tests

19 May 30, 2012 Update of REG0075 and REG0086 72
20 March 10, 2013 Update of REG0086 74
21 August 20, 2013 Update of REG0086 to add computation and test criteria, in- 88
troduce Discovery IGS 740, add new P011 extract and change
product name to DiscoveryTM IGS 730, DiscoveryTM IGS 740
22 September 4, 2013 Update of REG0086 to introduce Optima IGS320 88
23 September 4, 2014 Update of REG0086 to add Ruler. 84
Update of REG0075 and REG0086 to modify product name to
“InnovaTM IGS 620” and “InnovaTM IGS 630”.
24 March 4, 2015 Update of REG0075 and REG0086 to introduce “Optima IGS 84
330” and change product name to “Optima IGS 320”.
25 June 15, 2015 Update of REG0086 for Magnus Maquet OR table craddle axis 84
26 July 5, 2017 Update of REG0075 and REG0086 to introduce “InnovaTM IGS 80
5”, “InnovaTM IGS 6”, “DiscoveryTM IGS 7” and “DiscoveryTM IGS
7 OR”.
27 January 2021 Updated of REG0075 and REG0086 to introduce "Allia™ IGS 7", 84
"Allia™ IGS 7 OR", "Allia™ IGS Systems" and "Optima IGS Plus"
28 November 2021 Update of REG0075 and REG0086 to introduce "Allia™ IGS 3" 76
and "Allia™ IGS 5".
46-017564 Revision 28 HHS 9/76

Collimator Tests Contents
Contents
1 Safety ..................................................................................................................................................13
1.1 Safety ............................................................................................................................................................................................. 13
2 Collimator Test Requirements .........................................................................................................15

2.1 Collimator Test Requirements ............................................................................................................................................ 15
3 Collimator Function...........................................................................................................................17
3.1 Introduction................................................................................................................................................................................. 17
3.2 REG0071 - Functional Test - Auto Rad Collimator Version..................................................................................... 17
3.3 REG0072 - Functional Test - In-Table Fluoro Collimator Version......................................................................... 18
3.4 REG0073 - Functional Test - Vascular Collimator Version...................................................................................... 19
3.5 REG0074 - Functional Test - Manual Rad Collimator Version ............................................................................... 20
4 SID Test ...............................................................................................................................................23

4.1 REG0075 - SID Test................................................................................................................................................................... 23
5 Light to X-Ray Field Test....................................................................................................................25

5.1 REG0076 - Light to X-Ray Field Test.................................................................................................................................. 25
6 Center to Center Test ........................................................................................................................27

6.1 REG0077 - Center to Center Test for Bucky or Cassette Holder ......................................................................... 27
6.2 REG0078 - Center to Center Test for SFD...................................................................................................................... 28
6.3 REG0079 - Center to Center Test for Film Changers ................................................................................................ 30
6.4 REG0080 - Center to Center Test for Digital Systems .............................................................................................. 32
7 Field Size Indicator (Pointers to Actual Size) Test .........................................................................35

7.1 REG0081 - Field Size Indicator Test .................................................................................................................................. 35
8 Size to Size Tests................................................................................................................................37

8.1 REG0082 - Size to Size Test for Bucky or Cassette Holder ..................................................................................... 37
8.2 REG0083 - Size to Size Test for SFD.................................................................................................................................. 39
8.3 REG0084 - Size to Size Test for Gantry - Mounted Film Changer ........................................................................ 41
8.4 REG0085 - Size to Size Test for Digital Systems.......................................................................................................... 42
9 Fluoro Collimator to Image Intensifier Test....................................................................................47

9.1 REG0086 - Fluoro Collimator to Image Intensifier Test............................................................................................ 47
10 Image Overlap Test for Fixed Cones or Cylinders ........................................................................69

10.1 REG0087 - Image Overlap Test for Fixed Cones or Cylinders ............................................................................. 69
11 Collimator Light Field Intensity .....................................................................................................71

11.1 REG0088 - Collimator Light Field Intensity................................................................................................................. 71
46-017564 Revision 28 HHS 11/76

1
1 Safety
1.1 Safety
X-Ray Protection
WARNING

CAUTION
AMERICAS W–622
P.O. BOX 414
46-017564 Revision 28 HHS 13/76

1.1 Safety Collimator Tests
codes.
14/76 HHS 46-017564 Revision 28

2
2 Collimator Test Requirements
2.1 Collimator Test Requirements

Use theTable 2-1 Test Requirements (Notes 1, 2) on page 15 to determine the applicable tests for
your system, and be sure to read the notes. It could save you a lot of extra work; do it now.
These tests must be performed at installation and after any service that might affect the operation
of the collimator with regard to the listed functions. The sole exception is when the tests have
been performed in the factory, such as on the AMX-4. In such a case, you will have received separate
instructions advising you of the factory tests and specifying other tests (sometimes called signature
tests) which supersede the tests in this document.
In the Table 2-1 Test Requirements (Notes 1, 2) on page 15, read across in the rows labeled
Systems Types and examples to determine which column applies to your system.
Table 2-1 Test Requirements (Notes 1, 2)
System Types Auto Coll. to Auto Auto Coll. Auto Coll. to Man. Coll. to Man. Coll. Cone/Cyl.
Bucky or Coll. to to I.I. (Flu- Film Chang- any Recep. to Mobile to any
Cass. Holder SFD oro) er (Note 3) X–ray Receptor
Examples: XT Suspen- RFX/SFX, RFX/SFX, Integral film Table top AMX, VMX Tube
sion, Tube Stenos- Vascular, changers film, free Stand
Stand Re- cop (Note Remote Ta- such as AFM standing film
mote Table 6) ble, Stenos- or L–U changers
(Note 5) cop (Note
6)
Test Required
SID X X
Light to X-ray X X X
Center to Center X X X X (Note 7) X (Note 4)
(Note 7)
Field Size Indica- X X X (Note 4)
tors
Size to Size X X X
Lamp Brightness X X X
Image Overlap X
Fluoro Coll. to I.I. X
NOTE
1. All collimators require functional tests; see Chapter Collimator Function.

2. Mammo collimator tests are covered under 46–017565, HHS MAMMOGRAPHY TESTS.
3. Does not include mobile X-Ray units (AMX and VMX).
4. These are required by many state agencies but not by the FDA.
5. The Bucky of a remote table is similar to a SFD, and so the centering test is that of a
SFD. Refer to REG0078 - Center to Center Test for SFD on page 28.
6. The stenoscop is a C-Arm with a SFD (optional).
46-017564 Revision 28 HHS 15/76

2.1 Collimator Test Requirements Collimator Tests
7. Centering requirements will be met provided the X-Ray and light fields are aligned
and the cross-hairs are centered in the field.
16/76 HHS 46-017564 Revision 28

3
3 Collimator Function
3.1 Introduction
This test is divided into four versions to suit different types of collimators.
• Auto Rad Collimator Version
• Undertable Fluoro Collimator Version
• Vascular Collimator Version
• Manual Collimator Version
Certain collimators, which are part of specialized equipment, may have functional requirements in
addition to the generalized requirements of this section. Refer to the applicable service manual.
NOTE
Functional tests of a collimator must be complete before performing tests of the
remaining sections.
There is an HHS requirement for a minimum distance of 30 cm between the focal spot
and the patient for radiographic application, and 38 cm for fluoroscopic applications. Most
collimators accommodate this requirement in the design of the collimator. However, in
some cases a skin spacer or handle extension is used. Make sure that such features, if
provided, are indeed attached to the collimator.
3.2 REG0071 - Functional Test - Auto Rad Collimator

Version

ments

Requirements are defined in Collima- - -
tor service manual.
SID scale and/or SID indication must - -
be present.
Test data may be entered into the 46–017566, HHS FORMS, COMPLET- -
Laptop 3382 spreadsheet program, ING THE FDA 2579 AND GE DATA
or if this is not available, it may be RECORD FORMS
record in Form 3382.
Procedure
1. Check each mode of operation.
2. Verify that collimator enters correct mode when all conditions are met.
46-017564 Revision 28 HHS 17/76

3.3 REG0072 - Functional Test - In-Table Fluoro Collimator Version Collimator Tests
3. Also, verify that collimator does not enter above mode if any of the required conditions are not
met (change SID, remove cassette, etc.).
4. Check both table and wall receptors.
5. When collimator indicates an exposure inhibit condition, verify that exposures are not
possible.
6. Blades must move to new position in less than 5 seconds.
Refer to appropriate service manual for step-by-step procedure.
Sentry III – Direction 46–001414 (SM D5303C), Chapter 4.
ULTRANET SA - CG Y00W20L.04, Chapter 4.
Siemens - 2260325-100
NOTE
The FDA requires that, when the X-Ray beam is vertical, an automatic collimator
must be in the AUTO mode at least between 90 cm (35.4”) and 130 cm (51.2”) SID.
The collimator may go into the manual mode outside of that range.
Finalization
3.3 REG0072 - Functional Test - In-Table Fluoro

Collimator Version

ments

Procedure
1. Check conditions for mode and functions provided by mode as described in Table
3-5 Requirements in-table Fluoro Collimator Version on page 18.
Table 3-5 Requirements in-table Fluoro Collimator Version
Mode Conditions Required for Function Required for Mode

Mode
AUTOMATIC 1. SFD switch in “AUTO” • Shutters limit beam to visual area in Fluoro.
2. Cassette in place (ex- • Shutters change automatically to full size of selected film when
cept Full Digital Sys- cassette transfers (if applicable).
tem) • Shutters change automatically to full size of selected record
format during record operation.
• Collimator blades must move to any new position within 5
seconds.
18/76 HHS 46-017564 Revision 28

Collimator Tests 3.4 REG0073 - Functional Test - Vascular Collimator Version
Table 3-5 Requirements in-table Fluoro Collimator Version (Table continued)
Mode Conditions Required for Function Required for Mode

Mode
MANUAL 1. SFD switch in “MAN- • Shutters may be controlled manually, but maximum beam is
UAL” always limited to receptor size (Fluoro or Record format).
2. Cassette in place (ex- • Maximum field size changes automatically when cassette
cept Full Digital Sys- transfers but shutters will not increase opening, beyond format
tem) size.
• Collimator blades must move to any new position within 5
3
seconds.
Collimator Function
2. RECOMMENDATION: Collimator blades visible at edges of image in all fluoro and record modes
for all table positions with controls in maximum open position.
Finalization
3.4 REG0073 - Functional Test - Vascular Collimator

Version

ments

X-Ray exposure must not be possi- - -
ble, except at proper SID or SID
range. Collimator blades must move
to any new position in 5 seconds or
less.
Procedure
1. Check that exposure is prevented at incorrect SID, and permitted at correct SID (or range).
2. Check collimator shutters for response in 5 seconds or less.
Finalization
46-017564 Revision 28 HHS 19/76

3.5 REG0074 - Functional Test - Manual Rad Collimator Version Collimator Tests
3.5 REG0074 - Functional Test - Manual Rad Collimator

Version

ments

Manual collimators which bear an - -
HHS certification label may be instal-
led in the systems described in Ta-
ble 3-10 Requirements, Manual RAD
Collimator Version on page 20. If in
doubt, contact your supervisor. This
Table also includes any additional
system requirements that apply.
Procedure
1. Verify that radiographic system using manual collimator fits one of the types described in Table
3-10 Requirements, Manual RAD Collimator Version on page 20.
Table 3-10 Requirements, Manual RAD Collimator Version
System Description Additional Requirements

Mobile None
Rapid Film Changer (only) Coll. not used with table or wall bucky
Single Size Cassette & Fixed • Means provided to limit beam to cassette size
SID • Coll. interlocked to prevent operation at other SID's
• Coll. not used with table or wall bucky
Room W/O Permanent None
Bucky (e.g. table top only)
Single purpose systems None
(e.g. HYDRADJUST, UTILEX,
FRANKLIN HEAD UNIT), ACS
1000
20/76 HHS 46-017564 Revision 28

Collimator Tests 3.5 REG0074 - Functional Test - Manual Rad Collimator Version
Table 3-10 Requirements, Manual RAD Collimator Version (Table continued)
System Description Additional Requirements

Any radiographic system As of 1993 the FDA dropped the positive beam limitation (PBL) requirement. It
not described above is now possible to sell a system with a Manual Collimator in applications where
an auto-collimator would previously have been used.
There is one absolute requirement:
There must be documentation on site (preferably a system level operator's
manual) indicating that the system may be used with a manual collimator.
3
If a collimator and its associated receptor(s) are each capable of automatic colli-
mation, then auto-collimation must be functional. However, it is permitted to
Collimator Function
replace an auto-collimator with a manual collimator provided there is an on-site
operator's manual that describes system operation with a manual collimator.
2. Verify additional requirements noted, if any.
Finalization
46-017564 Revision 28 HHS 21/76

4
4 SID Test
4.1 REG0075 - SID Test


ments

The difference between the indicat- - -
ed SID and the actual SID may not
exceed 2% of the indicated SID. Re-
jection limit is 1.8%.
Procedure
NOTE
The procedure below uses no film. See 46–017560, HHS TOOLS if a film procedure is
desired.
1. Set the tube at a common SID using the operator’s indicator scale (on col. or bridge).
2. Insert a cassette into the Bucky and measure the distance between the focal spot locator decal
and the film plane using a pocket tape measure. Be careful that the Bucky does not drop down
out of its normal position when you make the measurement, and remember that the film plane
is half way down into the cassette.
NOTE
For a manual collimator and table top film, or for a mobile unit, this is a trivial test.
Just make sure that the SID indicated by the collimator tape (with tab extended)
agrees with your Sears tape measure. You’re done, skip the remainder of this section,
record the data.
3. Enter the results in the data record. Refer to table Bucky example below.
Figure 4-1 SID Test, Auto RAD Collimator to Table Bucky
46-017564 Revision 28 HHS 23/76

4.1 REG0075 - SID Test Collimator Tests
NOTE
At most one vertical and one horizontal measurement are required. Horizontal test
required only for system with detent. Compliance at maximum SID is verified if the
indicator tracks with a tape measure, i.e., 10” tube travel = 10” change in indicated
SID. All indicators, collimator tape, etc., must agree with measured SID.
4. Move the tube to maximum SID and verify that the actual distance traveled equals the travel
shown by the operator’s indicator scale. Note compliance in the data record form.
5. If so equipped, check that the collimator tape agrees with the previous measurements. If there’s
a tab on the end of the tape, it must be extended.
6. If the current tube and receptor can be angulated, then angulate them and repeat the test.
However, if when angulated, the only operator indicator is the collimator tape, then the test
need not be repeated for that receptor.
NOTE
Innova 3100/3100-IQ/3131-IQ, Innova 4100/4100-IQ, Innova IGS 530, 540, Innova™
IGS 5, Allia™ IGS 3, Allia™ IGS 5, 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 and Optima IGS 330 (Prerequisite SID
Calibration done):
• Remove the Tube Cover (Collimator side)
• At minimum and maximum SID, measure the distance between the
collimator output window and the Anticollision sensor windows. (With a Tape
measurement tool)
• Add 37 cm to this value and compare it to the displayed value.
Finalization
24/76 HHS 46-017564 Revision 28

5
5 Light to X-Ray Field Test
5.1 REG0076 - Light to X-Ray Field Test


ments

The total misalignment of the X–Ray - -
and light fields in either the lateral
or longitudinal directions may not
exceed 2% (rejection limit is 1.8%).
This test is normally performed at REG0092 - Light to X-Ray Field Test -
tabletop, or at the surface of a wall
unit, and so it is most convenient
to use the Long Afterglow Phosphor
tool, part no. 2120565. However, the
test can also be performed by utiliz-
ing a cassette in the image receptor,
including a digital receptor. To utilize
a cassette in a bucky, or cassette
holder or digital device use the alter-
native procedure.
Procedure
1. Beam angulation is irrelevant, set for convenience. Use common SID.
2. Select manual collimator mode. On some systems (e.g. remote tables) this may require first
selecting AUTO, then one on one format, and then going into override or OBL mode.
3. Place the phosphor tool on the table (or tape to wall unit).
4. Adjust the light field to a 25 cm square (12.5 cm in each direction), center the pattern as
necessary. Refer to example below: system software defaults to 12.5 cm for light field, but you
may change these values if necessary.
Figure 5-1 Light to X-Ray Field Test
46-017564 Revision 28 HHS 25/76

5.1 REG0076 - Light to X-Ray Field Test Collimator Tests
5. Select non–AEC mode and use the technique indicated on the phosphor tool (2 exposures of
125 kV and 200 mAs each, with 10 second delay between exposures).
6. With minimum lighting, remove phosphor plate from holder and quickly mark edges of field with
pencil (the covering on the phosphor is erasable). Now turn on room lights and read scales.
7. Enter the data on form 3382. The light field readings should all be 12.5 if you followed the
instructions; if necessary you may change the default readings on the light field.
Finalization
26/76 HHS 46-017564 Revision 28

6
6 Center to Center Test
6.1 REG0077 - Center to Center Test for Bucky or

Cassette Holder

ments

Misalignment of the center of the X– - -
Ray field and center of the receptor
may not exceed 2% (rejection limit is
1.8%).
Procedure
NOTE
For Remote Tables, refer to REG0078 - Center to Center Test for SFD on page 28.
1. The SIDs can be the same as used for the SID test; refer to data record form example below.
Figure 6-1 Center to Center Test for Table Bucky
NOTE
Only one vertical and one horizontal measurement is required. Compliance at other
SIDs is verified by noting that relationship between Bucky centering light and light
field center is relatively constant over SID range.
2. Insert a 12” x 14” loaded cassette into the Bucky or cassette holder, and center it.
3. Select manual collimator mode (override mode).
4. Using the collimator dials, adjust the field size indicators to 10” x 10”.
5. Select 60 KV and AEC mode; if no AEC use 2 to 5 mAs. Expose the film.
6. On the processed film, draw lines along the edges of the image to form a square. Then draw
diagonals to find the center of the image. This procedure often works better than trying to find
the corners of the image without drawing the perimeter lines.
46-017564 Revision 28 HHS 27/76

6.2 REG0078 - Center to Center Test for SFD Collimator Tests
7. Draw diagonals to find the center of the film and measure the distance between centers. This
is the centering error. It’s easy to find the corners of the film if you place the 2” wide steel ruler
on the edge of the film and draw a line parallel to the edge. Do this on all four sides and you will
have a rectangle with sharp corners, and one small enough so your ruler will stretch across it
diagonally. Enter the data onto the form.
8. There are separate forms for table Bucky and chest unit. Use the right one.
Finalization
6.2 REG0078 - Center to Center Test for SFD

Center to Center Test for SFD including Bucky on Remote Tables.

ments

may not exceed 2%. The rejection
limit is 1.8%.
As of June 2, 1993, the FDA drop- - -
ped the edge to edge requirements
in favor of simpler centering and siz-
ing requirements. Earlier revisions of
Direction 46–013894 dealt with the
completion of edge to edge meas-
urements in terms of peculiar cen-
tering and sizing requirements. The
procedure below is a welcome sim-
plification.
Procedure
1. Insert loaded cassette into the SFD (Bucky if you have a remote table).
2. Place .25” alum. or .03” Cu. plate on the table (which should be horizontal).
3. Select 1 on 1, min. SID, and collimate below format size. On some systems (e.g., remote tables)
this may require first selecting AUTO, then one on one format, and then going into override or
OBL mode.
4. Expose the film.
5. Repeat for the other formats and SIDs called for in the appropriate chart, but only do the
horizontal measurements for now.
28/76 HHS 46-017564 Revision 28

Collimator Tests 6.2 REG0078 - Center to Center Test for SFD
6. Process the films and determine the centering errors as follows: Draw diagonals across the
images, and diagonals across the film format corners. Mark the centers of image and format,
and measure the misalignment.
NOTE
The film format is defined by dividing the film into 2, 3, 4, etc. equal parts.
7. Enter the data into the data record form. Note the exposure with the worst centering error for
use below.
NOTE
Although the charts call for table vertical and Trendelenberg tests to be done with a
1 on 1 format, you should evaluate the horizontal films first. If any exposure shows
a significantly worse centering error (more than 2/3 of the rejection limit) than the
rest, then substitute that format and exposure for the 1 on 1 format called for in the
charts when you do the vertical and Trendelenberg measurements.
8. Complete the centering tests with the table in vertical and Trendelenberg positions. Process 6
films and complete data entry.
Center to Center Test

Table 6-5 Center to Center Test for SFD
Form 1 - 8835, 8735, and 8535 SFDs, with 14”x14” or 35 cm x 35 cm cassettes
Cassette Eng. X Met- Data is: X Eng. Met- OK to mix English &
is: ric ric metrix
Centering Image size Calc. field Size errors - % SID

size
EX SI Ta- Format da- % P/F lat. long lat. lo lat. lon sum P/F
P D ble ta . ng g.
1 mi Hor. 1 on 1 0.3 0.8 p 0.0 0.0
n
2 mi Hor. 2 on 1 long 0.4 1.4 p 0.0 0.0
n
3 mi Hor. 2 on 1 long 0.2 0.7 p 0.0 0.0
n
4 mi Hor. 3 on 1 long 0.3 1.0 p 0.0 0.0
n
5 mi Hor. 3 on 1 long 0.3 1.0 p 0.0 0.0
n
6 mi Hor. 3 on 1 long 0.3 1.0 p 0.0 0.0
n
7 ma Hor. 1 on 1 0.3 0.8 p 0.0 0.0
x
8 ma Vert. 2 ON 1 0.4 1.0 p 0.0 0.0
x LONG
9 ma Tren 2 ON 1 0.3 0.8 p 0.0 0.0
x d. LONG
NOTE
Exposure no. 2 was the worst in the horizontal mode, and so the vertical and
Trendelenburg exposures (nos. 8 & 9) have been performed in the same format as
exposure no. 2 (2 on 1).
Table 6-6 Center to Center for Remote Table
46-017564 Revision 28 HHS 29/76

6.3 REG0079 - Center to Center Test for Film Changers Collimator Tests
Table 6-6 Center to Center for Remote Table (Table continued)
Test data is in- X c OK to use inches w metric cass. etc. error messag-
in: ches m. es
cm. in.
Tube change SID 150. 59.1 error messag-
message ap- max 0 es
pears here
SID 105. 41.3
min 0
Centering
EXP SID Ta- Format Cas- data % P/F
ble sette
1 min Hor. 1 on 1 30 x 24 0.7 0.7 p
2 max Hor. 1 on 1 30 x 24 0.5 0.3 p
3 min Tren 1 on 1 30 x 24 0.9 0.9 p
d.
Note: Max and min SID are defaults for se- 4 max Tren 1 on 1 30 x 24 0.7 0.5 p
lected table d.
5 min Vert 1 on 1 30 x 24 0.4 0.4 p
.
6 max Vert 1 on 1 30 x 24 0.5 0.3 p
.
7 min Hor. 4on 1 43 x 35 0.4 0.4 p
8 max Hor. 4 on 1 43 x 35 0.6 0.4 p
Finalization
6.3 REG0079 - Center to Center Test for Film Changers


ments

may not exceed 2%. The rejection
limit is 1.8%.
30/76 HHS 46-017564 Revision 28

Collimator Tests 6.3 REG0079 - Center to Center Test for Film Changers

In order to perform a centering test - -
on a film changer, whether it’s free
standing or part of a Gantry mount-
ed system, you must be able to iden-
tify the selected portion of the film.
The selected portion of the film is de-
fined by the film changer input plane
opening. You may need to remove
covers and grids to expose the input
plane opening. Once there, find the
center of the opening and mark it
with a solder “X”.
Laptop 3382 spreadsheet program, ING THE FDA 2579 AND GE DATA 6

Integral film changers such as on the L/U or the AFM, and free standing film changers have the
same FDA requirement on centering, but integral changers are considered SFDs and therefore
also have a sizing requirement. Refer to REG0084 - Size to Size Test for Gantry - Mounted Film
Changer on page 41 for sizing tests of integral film changer.
NOTE
For a free standing changer, use the manual collimator test. For an integral changer, use
the Auto Rad Collimator to Gantry–mounted Film Changer test.
Procedure
1. Having first identified the center of the selected portion of the film as noted above, bring the
film changer into its normal position for film changer work. For integral changers the alignment
is automatic. For free standing units, align the tube to the changer using the normal operator
indicators.
2. With the collimator in an override mode if necessary, expose a film with the field size adjusted
to less than format size.
3. On the processed film, draw lines along the edges of the image to form a square, and then draw
diagonals to find the center of the image. This procedure often works better than trying to find
the corners of the image without drawing the perimeter lines.
4. Measure the distance between the center of the image and the center of the input plane as
indicated by the solder “X” that you affixed per the note above.
5. Enter the data in the data record form.
Table 6-9 Center to Center Test for Gantry Mounted Film Changer
Data entered inches x cm. error messages

in:
Enter min. SID: 80.0 cm. max. SID 130. c (enter digital readout with film changer
0 m. in position)
tube change mes-

sage appears here
Centering
46-017564 Revision 28 HHS 31/76

6.4 REG0080 - Center to Center Test for Digital Systems Collimator Tests
Table 6-9 Center to Center Test for Gantry Mounted Film Changer (Table continued)
SID da- % P/
ta F
min 0.6 0.8 p p
.
ma 1.0 0.8 p
x.
Finalization
6.4 REG0080 - Center to Center Test for Digital

Systems
Center to Center Test for Digital Systems: Chest Unit, Table Bucky or IDD.

ments

Ray field and center of the image
receptor may not exceed 2% of the
SID. The rejection limit is 1.8%.
It is most convenient to make all - -
measurements on a work station.
The procedure below allows use of
a work station or laser films.
recorded in form 3382.
Procedure
1. Center X–Ray tube to image receptor and establish desired SID.
2. Manually collimate smaller than the active area.
3. If necessary, place some aluminum, copper, or acrylic filtration in the field so as to allow the AEC
to operate normally.
4. Make an exposure at 60 kVp.
5. For a system with a work station, use the cursor to draw diagonals on the image, identifying
both the center of the X–Ray field and the center of the active area.
6. For a system with no work station, draw diagonals on the laser film, identifying both the center
of the X–Ray field and the center of the framing rectangle.
32/76 HHS 46-017564 Revision 28

Collimator Tests 6.4 REG0080 - Center to Center Test for Digital Systems
7. Measure the separation of the two centers, either using the cursor – for a system with a work
station, or using the tick mark scale imprinted on the laser film for a system with no work
station.
8. Determine the percentage misalignment: divide the actual misalignment by the SID. The
rejection limit is 1.8% of SID.
Finalization
46-017564 Revision 28 HHS 33/76

7
7 Field Size Indicator (Pointers to Actual Size)
Test
7.1 REG0081 - Field Size Indicator Test


ments

The difference between the indicat- - -
ed field size and the actual field size
may not exceed 2% in either direc-
tion; rejection limit is 1.7% in either
direction.
If you have performed (or plan to - -
perform) the center to center test,
then use that film and skip to Step 7.
Procedure
1. Use SID and angulation as indicated by form 3382.
2. If using film, insert a loaded 12” x 14” cassette into bucky or cassette holder and center. If using
phosphor tool (2120565), simply position this at the indicated SID (tabletop or tape to wall unit).
3. Select manual collimator mode.
4. Adjust collimator so that indicators are set for a 10” x 10” field.
5. Select 60 kV and AEC mode for film or follow exposure instructions on phosphor tool.
6. Make exposure(s) as directed.
7. Measure image size on film or read from phosphor tool and enter data on data form.
46-017564 Revision 28 HHS 35/76

7.1 REG0081 - Field Size Indicator Test Collimator Tests
8. Form may direct you to perform additional test at alternate angulation if initial test shows
marginal performance.
Figure 7-1 Pointers to Actual Field SIze Test
NOTE
Since the performance with beam vertical was marginal, the program requires a
second test with the beam vertical.
Finalization
36/76 HHS 46-017564 Revision 28

8
8 Size to Size Tests
8.1 REG0082 - Size to Size Test for Bucky or Cassette

Holder
Size to Size Test for Bucky including Remote Table.

ments

The difference between the X–Ray - -
field size and the nominal size of the
image receptor may not exceed 3%
in one direction and 4% for both di-
rections combined. Rejection limits
are 2.8% and 3.8% respectively.
This procedure uses only one expo- REG0090 - Bucky/Cass. Holder Test -
sure. It has been shown to be at least (Collimator rotation), , HHS TOOLS
as accurate, and much faster than for older technique with multiple ex-
older techniques. posures on 1 film
46-017564 Revision 28 HHS 37/76

8.1 REG0082 - Size to Size Test for Bucky or Cassette Holder Collimator Tests
Procedure
1. Refer to the appropriate test. There are separate tests for standard and remote tables. Refer to
standard table example below.
Figure 8-1 Size to SIze Test for Bucky
2. Select beam angulation, SID, and 3 cassettes as indicated on form.

3. Place a 12” x 14” loaded cassette in the Bucky and collimate about 2” smaller than receptor size.
On some systems (e.g., remote tables) this may require first selecting AUTO, then one on one
format, and then going into override or OBL mode.
4. Tape a piece of finely ruled graph paper (can be printed from README file in laptop program
group XR TOOLS, or can be copied from form 3382, 46–017566, HHS FORMS, COMPLETING THE
FDA 2579 AND GE DATA RECORD FORMS) onto the collimator window and use it to measure
the size of the light field in arbitrary units. Enter data onto form 3382 (21 and 22 units in the
example).
5. Expose the film and measure the image size. Enter data onto form (25.4 and 25.2 in the
example).
6. With the collimator in auto, place small, medium, and large cassettes into the Bucky and
measure the corresponding light field size at the collimator (arbitrary units). Enter data onto
form in the column labeled Light Field.
Finalization
38/76 HHS 46-017564 Revision 28

Collimator Tests 8.2 REG0083 - Size to Size Test for SFD
8.2 REG0083 - Size to Size Test for SFD


ments

The difference between the X-Ray - -
field size and the selected portion of
the film (format size) may not exceed
3% in one direction and 4% for both
directions combined. Rejection limits
are 2.7% and 3.4% respectively.
The film format is defined by dividing - -
the film into 2, 3, 4, etc. equal parts. 8
Per the FDA, the presence of a mask
is irrelevant. The X-Ray field must
Size to Size Tests

always be compared to the format
size, even if the mask is smaller than
the format size. For this reason, all
images are measured at table top,
i.e., prior to the SFD.
Film is not required for the size - -
to size portion of the test provid-
ed you are using the phosphor tool
(2120565). If you are not using this
tool then you must use one of the
vinyl cassettes from the HHS kit.
NOTE
For Remote Tables, refer to REG0082 - Size to Size Test for Bucky or Cassette
Holder on page 37.
Procedure
1. Refer to the data record, Figure 8-2 Size to size Test for SFD on page 40. Prior to making film
tests enter the data for the 5 cells above the chart. If using the hard copy form, you will have
46-017564 Revision 28 HHS 39/76

8.2 REG0083 - Size to Size Test for SFD Collimator Tests
to make a magnification film, calculate magnification, and enter the results in the cells labeled
program-calculated mag. factors.
Figure 8-2 Size to size Test for SFD
2. It is only necessary to complete one of the four tables. Select a table corresponding to the most
commonly used cassette size for this installation. Multiple tables may be completed if desired.
Use auto collimation for size to size test.
3. If using the phosphor tool remove the plate and reinsert it in the holder face down. Center the
tool (approximately) under fluoro; open end should be towards the head of the table. Cover the
tool with lead and expose at 100 kV, 200 to 400 mAs.
If using film place the vinyl cassette on the table, center it, cover it with .25 aluminum or .03
copper, and expose at 60 - 80 kV using AEC mode.
4. If using the phosphor tool examine the image in very dim light. Using a soft pencil, quickly mark
the edges of the field on the phosphor (the covering is erasable). Turn on the lights and read the
image size. Add N–S (for longitudinal) and E–W (for lateral) readings, and enter dimensions onto
the form.
If using film measure the image using a view box. Image density must be between 1.0 and 1.2.
Enter the dimensions onto the form.
40/76 HHS 46-017564 Revision 28

Collimator Tests 8.3 REG0084 - Size to Size Test for Gantry - Mounted Film Changer
5. Repeat the phosphor tool or film tests for each format called for in the chart. Once exposed to
room light the phosphor will continue to glow for 1 - 3 minutes. Allow adequate time between
exposures for the phosphorescence to subside.
Finalization
8.3 REG0084 - Size to Size Test for Gantry - Mounted

Film Changer

ments
Condition Reference Effectivity 8

The difference between the X–Ray - -
Size to Size Tests

field size and the selected portion of
the film may not exceed 3% in one
direction and 4% for both directions
combined. Rejection limits are 2.8%
and 3.8% respectively.
The selected portion of the film is de- - -
fined by the film changer input plane
opening. You may need to remove
covers and grids to expose the open-
ing.
Procedure
1. Refer to the example below (Figure 8-3 Size to Size Test for Gantry-Mounted Film Changer -
Center to Center Instructions on page 41 and Figure 8-4 Size to Size Test for Gantry-Mounted
Film Changer - Size to size Test Instructions on page 42).
Figure 8-3 Size to Size Test for Gantry-Mounted Film Changer - Center to Center Instructions
NOTE
Refer to REG0079 - Center to Center Test for Film Changers on page 30.
46-017564 Revision 28 HHS 41/76

8.4 REG0085 - Size to Size Test for Digital Systems Collimator Tests
Figure 8-4 Size to Size Test for Gantry-Mounted Film Changer - Size to size Test Instructions
2. Position the Gantry with beam vertical, tube at bottom, minimum SID.
3. Collimate to approximately 25 cm by 25 cm or 10” x 10”.
4. Tape a piece of finely ruled graph paper (can be printed from README file in laptop program
group XR TOOLS, or can be copied from form 3382, 46–017566, HHS FORMS, COMPLETING THE
FDA 2579 AND GE DATA RECORD FORMS) onto the collimator window and use it to measure the
size of the light field in arbitrary units. Enter data onto form 3382 (5 and 5 units in the example).
5. Advance the film changer to the in–place position and load film in magazine.
6. Expose the film and measure the image size. Enter data onto form (25.4 and 25.2 in example).
7. Place the collimator in auto and measure the corresponding light field size, again using the
graph paper to obtain arbitrary units. Enter onto form in columns labeled Light Field.
8. Repeat Step 7 at the maximum SID.
Finalization
8.4 REG0085 - Size to Size Test for Digital Systems

Size to Size Test for Digital Systems: Chest Unit, Table Bucky or IDD.

ments

It is most convenient to make all - -
measurements on a work station.
The procedure below allows use of
a work station or laser films, and can
be used for automatic or manual col-
limators.
42/76 HHS 46-017564 Revision 28

Collimator Tests 8.4 REG0085 - Size to Size Test for Digital Systems

recorded in form 3382.
Procedure
1. Center X–Ray tube to image receptor and establish desired SID.
2. If necessary, place some aluminum, copper, or acrylic filtration in the field so as to allow the AEC
to operate normally.
3. Refer to Illustration below. Select 3 standard formats and indicate these selections in the upper
table. Enter data, as appropriate, in the 5 boxes below the table.
This example is for chest unit, however, the form includes pages for table bucky. This is part of
form 3382. Blank copy is in 46–017566, HHS FORMS, COMPLETING THE FDA 2579 AND GE DATA
RECORD FORMS. Spreadsheet version available on Laptop.
Figure 8-5 Example Chest Unit 8
Size to Size Tests
NOTE
Refer to REG0082 - Size to Size Test for Bucky or Cassette Holder on page 37.
4. NOTE
There are two possible techniques for performing this test, corresponding to the two
buttons on the form. Which technique is used, will depend on the outcome of Step 5.
Make an exposure at 60 kVp in each of the three selected formats.
46-017564 Revision 28 HHS 43/76

8.4 REG0085 - Size to Size Test for Digital Systems Collimator Tests
5. Examine the images. If all images show collimator blades on all 4 sides the process is trivial –
refer to note following this step. If any image does not show collimator blades on all 4 sides you
will need to use the alternative technique and make one additional exposure.
6. NOTE
If all images show collimator blades on all 4 sides skip down to Step 15. If any
image does not show collimator blades on all four sides you will use an indirect
measurement technique for all images (this is simpler than using 2 different
techniques); in this case proceed with Step 6.
You will determine the location of the X–Ray field edge indirectly. This is not difficult but requires
one additional exposure. The previous images will not be used; you may want to delete them to
avoid confusion.
7. Set the collimator to the largest selected format, and then manually reduce the field size by an
inch or two in each direction.
8. Obtain a piece of finely ruled graph paper, such as the pattern available in form 3382 or
printable from the Read_me file of the Laptop HHS 3382 program. Tape the pattern to the end of
the collimator.
9. Measure the size of the light field as it exits the collimator in pattern units; the units are
arbitrary. Enter the light field data on the form. In the example, the light field measurements are
21 div by 22 div.
10. Make an exposure at 60 kVp. This is the only exposure required.
11. Use the cursor to measure the size of the image from Step 10 at the work station, or use the tick
marks on the laser film to make this measurement if there is no work station. Enter the X–Ray
field size measurements onto the form. In the example, these measurements are 29 cm and 30
cm. Notice that the program calculates lateral and longitudinal correspondence ratios (if using a
paper form you need to calculate these ratios).
12. Return the collimator to the automatic mode, or, if a manual collimator, return to the normal
size for the selected format. Measure the size of the light field using the paper pattern. Enter the
data on the form in the lower table. In the example the data is 26 and 31.
13. Repeat Step 12 for each selected format and enter the data into the lower table.
14. The program calculates the X–Ray field sizes at the image receptor. Notice that the 35 cm by 43
cm format calculates to 35.9 cm. This image overlapped the active area of 35 cm and failed to
show a collimator blade in this direction.
15. NOTE
If using the paper form, it will be necessary to calculate the X–Ray field to light field
size ratios as shown. Then, in the bottom table, multiply the lateral and longitudinal
light field sizes by the appropriate ratios to obtain the calculated X–Ray field sizes.
Calculate the percentage errors.
If all of the images from Step 5 show 4 collimator blades, then simply measure the size of each
X–Ray field using the work station cursor (scale factor = 1), or the tick mark scale on the laser
film.
16. Refer to Figure 8-6 Example Collimator Blades on page 45. Click on the left hand button (“direct
field size entry” or “rotating collimator”) in order to access the “Measured XR Field” portion
of the lower table for data entry. Enter the X–Ray field size measurements of Step 15 onto
form 3382 in the lower table in the area labeled “Measured XR Field.” If using the paper form,
calculate the percentage errors and enter as shown.
NOTE
This example is for images that show collimator blades on all four sides. Form
appears as shown only after clicking left hand button.
44/76 HHS 46-017564 Revision 28

Collimator Tests 8.4 REG0085 - Size to Size Test for Digital Systems
Figure 8-6 Example Collimator Blades
Size to Size Tests

NOTE
Refer to REG0082 - Size to Size Test for Bucky or Cassette Holder on page 37.
Finalization
46-017564 Revision 28 HHS 45/76

9
9 Fluoro Collimator to Image Intensifier Test
9.1 REG0086 - Fluoro Collimator to Image Intensifier

Test

ments

Ruler 1 - - -

The area that is being X-rayed may - -
not extend beyond what is displayed
on the monitor by more than 3%
in either lateral or longitudinal direc-
tions, or 4% for the sum of the two
directions. Rejection limits are 2.8%
and 3.8% respectively. For Innova
2100-IQ, Innova 3100/3100-IQ, Inno-
va 4100/4100-IQ, Innova IGS 520,
530, 540, Innova 2100-IQ (Optima
Edition), Innova 3100-IQ (Optima Ed-
ition), Innova 2121-IQ, 3131-IQ, Inno-
va™ IGS 5, Allia™ IGS 3, Allia™ IGS 5,
Innova™ IGS 620,Innova™ IGS 630,In-
nova™ 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 and Optima IGS 330 depending
of the P011 - Collimator Gain calibra-
tion content (see below Procedure
section) either the 4 blades shall be
visible in all the angulation (and di-
rect test is required) or one vertical
and one horizontal collimator blade
shall be visible (and indirect test
shall be executed).
Test to be performed in Auto-ex- - Allia™ IGS Systems and Allia™ IGS 3
posure IQStd with the balanced IQ/
dose mode and/or in Auto expo-
sure RDL with the balanced IQ/dose
mode.
46-017564 Revision 28 HHS 47/76

9.1 REG0086 - Fluoro Collimator to Image Intensifier Test Collimator Tests
NOTE
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 orDiscovery™ IGS 7 or
Discovery™ IGS 7 OR.
NOTE
NOTE
It is recommended to use a spreadsheet to record Test data results during execution of
the procedure and enter formula so calculation can be made faster.
Definitions
Collimator blades (rectangular and corner): For Head up display mode (Discovery™ IGS Systems
and Allia™ IGS 7 and Allia™ IGS 7 OR Systems only), three sets of blades are used in the collimator:
• Two sets of rectangular shaped facing blades allowing to perform square or rectangle X-ray
fields.
• One set of 4 blades coming from the corners of the square (or rectangle) and allowing forming
an octagonal X-ray field.
The illustration below presents the different sets of blades
For other systems (Innova, Optima and Allia™ IGS 3, Allia™ IGS 5 Systems), the collimator
corner blades are not available.
Collimator gain: The collimator gain is a factor applied to the system blade opening. It is a
percentage of the System blade opening adjustable from 80 to 100.
Effective image area: Part of the image reception area that is configured to receive an X-ray pattern
that can be processed for display or storage.
Gain correction: (refer to Collimator gain) As measurements are made on the display monitor with
a gain applied to see all blades, it is necessary to correct the gain to deduce what happens when
applying the real collimator gain of the system.
Head up display mode: In fluoroscopy and record modes, the image displayed on the live display
can be automatically rotated with the patient head towards the upper level of the screen when the
system is on a swivel trajectory. This display mode is called the Head up display. This display mode is
only available on Discovery™ IGS Systems and Allia™ IGS 7 and Allia™ IGS 7 OR Systems.
Image reception area: Surface on which an X-ray pattern is received (in our case: the detector
entrance plane).
Image rotation angle: This is the angle applied to rotate the image to recover the Head up display
mode. It is computed from the gantry angulations (for example swivel).
48/76 HHS 46-017564 Revision 28

Collimator Tests 9.1 REG0086 - Fluoro Collimator to Image Intensifier Test
Magnification factor: All image acquired at detector level are magnified in order to fit in a same
DL monitor size. As the measurements are made at monitor level, it is necessary to apply a
magnification factor to calculate the discrepancies at detector (or receptor) level.
Monitor: It refers to the Live image display screen. It can be a 19’’ monitor or LDM.
Monitor edges: The edges of the image displayed on the monitor. Refer to the illustration
below. The monitor edges are also called “monitor image area border” in Figure 9-5 Points to be
measured on page 54.
Fluoro Collimator to Image Intensifier Test

X-ray field (square or octagonal): The X-ray field is the area on the detector surface intersected by a
radiation beam within which the radiation intensity exceeds a specific level.
Direct Test (non Innova)

The requirements of the test can be met by adjusting the collimator so that, when in the Auto
mode with maximum opening, 4 blades are visible on the monitor at all times (16, 12, 9, 6, 4.5 inch
image tube field sizes; maximum SID, minimum SID). Table (for R/F) or C-arm (for Vascular) in various
positions.
46-017564 Revision 28 HHS 49/76

Figure 9-1
Direct Test for Innova

1. For Innova 2100-IQ, Innova 3100/3100-IQ, Innova 4100/4100-IQ of first generation, where in
the SUIF P011 - Collimator Gain calibration, it is clearly mentioned that for “collimator gain
50/76 HHS 46-017564 Revision 28

calibration must be adjusted with the four blades barely visible in all cases” (see figure
below), apply the direct procedure and just record the results of blades visibility.
Figure 9-2

2. Otherwise, for Innova 3131-IQ, Innova 2121-IQ and Innova™ IGS 620, Innova™ IGS 630, Innova™
IGS 6 frontal and lateral planes, Innova 2100-IQ, Innova 3100-IQ, Innova 4100-IQ of second
generation, Innova 2100-IQ (Optima Edition), Innova 3100-IQ (Optima Edition), Innova IGS 520,
530, 540, Innova™ IGS 5, Allia™ IGS 3, Allia™ IGS 5, 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 and Optima IGS 330, where in the SUIF P011 - Collimator
Gain calibration, it is clearly mentioned that for collimator gain adjustment, ”there shall be at
46-017564 Revision 28 HHS 51/76

least one horizontal and one vertical rectangular collimator blade visible”, the indirect
test described in next section must be made to measure misalignment.
Figure 9-3
Indirect Test for Innova / Discovery / Allia / Optima
NOTICE
(For Discovery™ IGS Systems and Allia™ IGS 7 and Allia™ IGS 7 OR Systems) For
Discovery™ IGS Systems and Allia™ IGS 7 and Allia™ IGS 7 OR Systems with Head up
display mode, the whole compliance verification process is divided in two consecutive
procedures. First execute “Indirect Test for Innova / Discovery / Allia / Optima” which
checks compliance for square X-ray field, then, execute “Additional indirect test for
Discovery™ IGS Systems and Allia™ IGS 7 and Allia™ IGS 7 OR Systems with Head up
display mode”, which verifies the compliance for octagonal X-ray field. For Discovery™
IGS Systems and Allia™ IGS 7 and Allia™ IGS 7 OR Systems without Head up display
mode, only execute “Indirect Test for Innova / Discovery / Allia / Optima”.
Goal of the procedure

The procedure uses the two following technical hypothesis:
1. Collimator gain applicability is linear (Blades opening = System blade opening x Collimator Gain /
100).
52/76 HHS 46-017564 Revision 28

2. The rotation of blades is negligible. Rectangular blades are adjusted to be parallel to the monitor
edges.
The blades are entered in the field so that they can be visible by reducing collimator gain. The
distance between the imaged X-ray field and monitor edges is measured for each blade. All the
computations are made after gain correction and magnification factor applied to correspond to
distances at detector level.
Set geometrical parameters

1. Set table to rotation at 0°.
2. For Single plane / Biplane frontal plane, set the gantry in LAO = 90°, CAU = 45°.
For Biplane, set lateral plane: LAO = 2°; SOD = 71 cm.
3. Set the table out of the X-ray beam.
Do not modify CAU angulation at this point (CAU angulation depends on the table rotation. If
table is rotated, it is acceptable that CAU angulation is different from 45°).
4. Set the source image to the desired SID, start by SID min, then SID medium and SID max (refer
to table in Formulas for Computation and rejection criteria on page 59 for typical SID values).
Set X-Ray preliminaries

1. If applicable, de-activate Head up display mode (rotation button is not highlighted). Head up
9
display mode shall stay de-activated for this whole procedure.

2. Access the Gain Calibration:
a. If not done on the DL Browser, End Exam.
b. Click on the Service button of the DL browser, hence the Service User Interface (SUIF)
appears.
c. Select Configuration.
d. Then, click on the left side tree on Collimator Gain. The following page then appears:
Figure 9-4 Collimator gain window
3. Fill the Test Data Results report with the actual Collimator gain value Cg.
4. Create a new patient and a new exam.
5. On the DL console, choose a protocol with Fluoro Normal 30 fps.
6. On the DL console, select smallest Field Of View (FOV).
46-017564 Revision 28 HHS 53/76

7. De-activate autoshutter. Autoshutter shall stay deactivated until the end of the procedure.
NOTE
Verify collimation is in automatic mode (lights on the button aside of the collimator
blades joystick are ON). To recover automatic collimation, press “autoformat” button.
8. Switch back to SUIF window and set a new collimator gain value (Cgn) to make the 4 rectangular
collimator blades visible. Use fluoro to check blades visibilities. Verify that all blades at visible at
SID Min and SID Max.
9. Record the new collimator gain Cgn in the Test Data Results report.
10. Switch-out the SUIF window so the DL browser appears.
Measurements procedure
1. Measure Monitor image width (refer to Figure 9-11 on page 60) and fill the Test Data Result
with this value.
2. Select on the DL Console the FOV Max.
3. Press the fluoro footswitch. A figure similar to the one below is displayed on the monitor.
Figure 9-5 Points to be measured
NOTE
The figure below is a zoom of above figure where there is a detailed explanation of
the measurement of a point, here point “c1”. It shall be done in the same way for the
other points.
The measurement shall be performed at the center of image edges.
54/76 HHS 46-017564 Revision 28

Figure 9-6 Zoom in on point c1
4. Measure on the monitor “c1”, “c2”, “d1” and “d2” in cm as explained on the above figures.
5. Fill also the Test Data Results report with the obtained “c1”, “c2”, “d1” and “d2” values for the
FOV of interest.
6. Redo Step 3 to Step 5 with the other FOVs.
7. Repeat the indirect test for SID medium, then for SID max.
NOTE
Medium SID is the mid value between max SID and min SID
9
Analyze the Test Data Results

Verify the measured data points are all recorded and formulas specified in “Formulas for Indirect
Test for Innova / Discovery / Allia / Optima” are correctly used to compute the rejection criteria. For
each point do the following:
1. Check any fail in the Test Data Results report.
2. If any fail, go to Mini-Troubleshooting Guide on page 58.
3. For Discovery™ IGS Systems and Allia™ IGS 7 and Allia™ IGS 7 Systems with Head up display
mode, if no fail, perform “Additional indirect test for Discovery™ IGS Systems and Allia™ IGS 7
and Allia™ IGS 7 OR Systems with Head up display mode”. The compliance verification is not
complete until you passed both procedures.
4. For other systems, if no fail, the compliance verification is done.
Additional indirect test for Discovery™ IGS Systems and Allia™ IGS 7 and Allia™ IGS 7 OR
Systems with Head up display mode
This part is only applicable for Discovery™ IGS Systems and Allia™ IGS 7 and Allia™ IGS 7 OR
Systems with Head up display mode.
• It requires to first position the system in a defined setup and then make some measurements
on the DL Live Screen, for octagonal and square X-ray fields.
• If the excel file is available, the measurements have to be entered in the Data Result file and the
decentering of corner blades is deduced by computations.
• If the excel file is not available, the decentering of corner blades and compliance of octagonal
X-ray field have to be computed and deduced with the help of the calculations provided in part
“Formulas for Additional indirect test for Discovery™ IGS Systems and Allia™ IGS 7 and Allia™ IGS
7 OR Systems with Head up display mode”.
Set geometrical parameters

Set the geometrical parameters as indicated below:
46-017564 Revision 28 HHS 55/76

1. Rotate the table so that the rotation angle is 0°.

2. Set the gantry in PA by using Autopos joystick: LAO = 0°, CAU = 0°.
3. Move AGV swivel to apply an image rotation angle of +45° or -45°. To do that, look at the virtual
collimation. The corner blades – dashed lines – shall be perfectly parallel to the monitor edges,
like on Illustration 7 below.
Figure 9-7 Virtual Collimation corner blades (dashed lines) are perfectly parallel to the
monitor edges
The angle between the AGV axis and the table axis shall be about 45°, as an example is shown in
Illustration 8 below.
Figure 9-8 Example of setup (diagram is not on scale)
(For Discovery™ IGS Systems and Allia™ IGS 7 Systems with InnovaIQ table or InnovaIQ OR table)
On Live monitor, verify that C-arc, Pivot, and tilt angles are equal to 0°. Record swivel angle (L), in
Test Data Results, if applicable. Verify that the swivel is equal to 45° or – 45°.
(For Discovery™ IGS Systems and Allia™ IGS 7 OR Systems with Magnus Maquet OR table) On Live
monitor, verify that C-arc, Pivot, craddle and tilt angles are equal to 0°. Record swivel angle (L), in
Test Data Results, if applicable. Verify that the swivel is equal to 45° or – 45°.
56/76 HHS 46-017564 Revision 28

NOTE
NB: swivel angle is equal to the image rotation angle (θ):
Set X-Ray preliminaries

1. If needed, create a new patient and a new exam.
2. On the DL console, choose a protocol with Fluoro Normal 30 fps.
3. On the DL console, select smallest Field Of View (FOV).
4. De-activate autoshutter. Autoshutter shall stay deactivated until the end of the procedure.
5. Verify collimation is in automatic mode (lights on the button aside of the collimator blades
joystick are ON). To recover automatic collimation, press “autoformat” button.
6. Verify Head up display mode is activated (rotation button is highlighted).
7. Make a Fluoro acquisition.
On the screen, you should see an octagonal X-ray field, with 4 edges parallel to the monitor
edges.
8. Set collimator gain to make the 4 collimator corner blades visible. Use fluoro to check blades
visibility.
9
9. Record the new collimator gain (Cgn’) in Data Results report.

Measurements procedure
If you don’t have the Test Data Result file, use instruction found in “Formulas for Additional indirect
test for Discovery™ IGS Systems and Allia™ IGS 7 and Allia™ IGS 7 OR Systems with Head up display
mode”.
1. Press Fluoro switch. A figure similar to the one below is displayed on the monitor.
2. Measure on the monitor c1’, c2’, d1’ and d2’ in cm as explained on the Illustration 9 below. These
are the data for the corner blades.
Figure 9-9 Octagonal X-ray field to measure corner blades values: c1’, c2’, d1’ and d2’
3. Record c1’, c2’, d1’ and d2’, in Test Data Results report if applicable.
46-017564 Revision 28 HHS 57/76

4. Deactivate Head up display mode (Rotation button is not highlighted).

5. Make a Fluoro acquisition.
On the screen, you should see a square X-ray field, with edges parallel to the monitor edges.
6. Measure on the monitor c1, c2, d1 and d2 in cm as explained on Figure 9-10 Square X-ray field to
measure rectangular blades values: c1, c2, d1 and d2 on page 58 below.
Figure 9-10 Square X-ray field to measure rectangular blades values: c1, c2, d1 and d2
7. Record c1, c2, d1 and d2, in Test Data Results report if applicable.
Analyze the Test Data Results

Verify the measured data points are all recorded and formulas specified in “Formulas for Additional
indirect test for Discovery™ IGS Systems and Allia™ IGS 7 and Allia™ IGS 7 OR Systems with Head up
display mode” are correctly used to compute the rejection criteria. For each point do the following:
1. Check any fail in the Test Data Results report for compliance of octagonal X-ray field.
2. If any fail, go to Mini-Troubleshooting Guide on page 58.
Mini-Troubleshooting Guide
1. Use the table below to identify the problem.
In case of fail in” Indirect Test for Innova / Discovery / Allia / Optima”, check Table
9-4 Troubleshooting guide: compliance of square X-ray field on page 58.
Table 9-4 Troubleshooting guide: compliance of square X-ray field
Problem No. Possible cause Recommended action

Result of “Actual ver- 1 Blade not visible or too visi- Do “P011 Calibration”
sus displayed FOV” ble on the monitor
failed
58/76 HHS 46-017564 Revision 28

Table 9-4 Troubleshooting guide: compliance of square X-ray field (Table con-
tinued)

Results of “Discrep- 2 Alignment of the detector Do Alignment and SID (re-
ancies of X-Field ver- fer to “RG09 Detector Align-
sus Image reception ment” of Power On Installa-
area” failed tion in SM CD/DVD).
If after an alignment redo the
test still fails execute Par-
ticular case: Collimator gain
value limitation on page 59.
In case of fail in “Additional indirect test for Discovery™ IGS Systems and Allia™ IGS 7 and
Allia™ IGS 7 OR Systems with Head up display mode”, check Table 9-5 Troubleshooting guide:
compliance of octagonal X-ray field on page 59.
Table 9-5 Troubleshooting guide: compliance of octagonal X-ray field

Result of “Actual ver- 1 Blade not visible or too visi- If blades are not visible:
sus displayed FOV” ble on the monitor Lower collimator gain value:
failed (Gain_new = Gain_old – 1);
enter new collimator gain in 9
excel sheet and check other

test ID.
If blades are too visible: In-
crease collimator gain value:
(Gain_new = Gain_old + 1);
enter new collimator gain in
excel sheet and check other
test ID.
Results of “Discrep- 2 Alignment of the detector or Do Alignment and SID (re-
ancies of X-Field ver- collimator fail fer to “RG09 Detector Align-
sus Image reception ment” of Power On Installa-
area” or “Percentage tion in SM CD/DVD).
of overlap” or “Maxi- If after an alignment redo
mum extent” failed the test still fails check the
results of corner blade de-
centering. If it is also failed,
there might be a problem
with the collimator. Replace
collimator.
2. Carry out the necessary steps to correct the error. If problem persists, contact Service Support.
Particular case: Collimator gain value limitation

Execute the following steps if you re-did alignment once and the test still fails.
1. Get the Max Collimator Gain Allowed computed in the Test Data Results Report.
2. Open the SUIF and set the collimator gain value to the Max Collimator Gain Allowed.
NOTE
With this new value test turns to pass.
Formulas for Computation and rejection criteria
46-017564 Revision 28 HHS 59/76

Formulas for Indirect Test for Innova / Discovery / Allia / Optima

This part verifies the compliance of square X-ray field.
1. If not done yet, record collimator gain value; actual collimator gain = Cg.
Record new collimator gain with 4 collimator blades visible = Cgn
Record SID
Record selected FOV = FOV using table below
FOV selected Detector size
20 cm 30 cm 40 cm
FOV0 20 30 40
FOV1 17 20 32
FOV2 15 16 20
FOV3 12 12 16
Record Monitor Image width (usually 28 cm for 19’’ monitors, larger for LDM).
Figure 9-11
2. Compute G, which is the magnification factor between receptor plane and monitor plane.
G = FOV selected size / Monitor Image width
3. Measure discrepancies
a. If not done yet, make measures on monitor c1, c2, d1, d2. Refer to Figure 9-5 Points to be
measured on page 54 and Figure 9-6 Zoom in on point c1 on page 55.
60/76 HHS 46-017564 Revision 28

b. Compute c1r, c2r, d1r, d2r which are c1, c2, d1, d2 at receptor plane and with actual
collimator gain.

4. Compute Collimator Maximum_Gain_Allowed regarding primary barrier coverage.
First, calculate Maximum misalignment at min SID and max FOV (F value):
NOTE
The result is expressed in mm
Second, compute Maximum_Gain_Allowed using formula from illustration:
Figure 9-12
Where:
INNOVA / AL- INNOVA / ALLIA™ INNOVA / AL- DISCOVERY / DISCOVERY /
LIA™ IGS 5 / IGS 3 / ALLIA™ LIA™ IGS 5 ALLIA™ IGS 7 / ALLIA™ IGS 7 /
OPTIMA IGS IGS 5 / OPTIMA ALLIA™ IGS 7 ALLIA™ IGS 7
PLUS / OPTI- CL320i/CL323i / OR OR
MA IGS 320 OPTIMA IGS PLUS /
OPTIMA IGS 330
Detector 20 Detector 30 cm Detector 40 Detector 30 Detector 40
cm cm cm cm
A = max FOV 20 30 40 30 40
46-017564 Revision 28 HHS 61/76

INNOVA / AL- INNOVA / ALLIA™ INNOVA / AL- DISCOVERY / DISCOVERY /

LIA™ IGS 5 / IGS 3 / ALLIA™ LIA™ IGS 5 ALLIA™ IGS 7 / ALLIA™ IGS 7 /
OPTIMA IGS IGS 5 / OPTIMA ALLIA™ IGS 7 ALLIA™ IGS 7
PLUS / OPTI- CL320i/CL323i / OR OR
MA IGS 320 OPTIMA IGS PLUS /
OPTIMA IGS 330
Detector 20 Detector 30 cm Detector 40 Detector 30 Detector 40
cm cm cm cm
B = primary bar- 228 335.5 433 335.5 433
rier size (mm)
C = primary bar- 27 12 11.5 12 11.5
rier behind de-
tector plane dis-
tance (mm)
D = primary bar- 1.25 1.25 1.25 1.25 1.25
rier 6 sigma de-
centering (mm)
E = SID min (cm) 85 89 95 99 99
F = Max mis- Computed in Computed in proce- Computed in Computed in Computed pro-
alignment in procedure dure procedure procedure cedure
Max FOV at min
SID
5. Interpret results, test is “pass” if:

For all FOVs and all SIDs, X-Field versus image reception area discrepancies match following
criteria:
• abs(c1r) + abs(c2r) < 2.8%*SID
• abs(d1r) + abs(d2r) < 2.8%*SID
• abs(c1r) + abs(c2r) + abs(d1r) + abs(d2r) < 3.8%*SID
Actual versus displayed FOV:
• abs(FOV length – FOV) < 1% SID
• abs(FOV width – FOV) < 1% SID
6. Set the final collimator gain in the SUIF
Open the SUIF and set the new collimator gain value according to the rules below:
• Case#1: actual collimator gain Cg value is greater than the Maximum_gain_allowed => set
the collimator gain to the Maximum_gain_allowed value
• Case#2: actual collimator gain Cg value is less or equal to the Maximum_gain_allowed
=> set the gain to a value between the actual collimator gain Cg and the
Maximum_gain_allowed
In case of problem, refer to mini-troubleshooting guide.
Formulas for Additional indirect test for Discovery™ IGS Systems and
Allia™ IGS 7 and Allia™ IGS 7 OR Systems with Head up display mode
This part is only applicable for Discovery™ IGS Systems and Allia™ IGS 7 and Allia™ IGS 7 OR
Systems with Head up display mode.
It verifies the compliance of octagonal X-ray field.
The computations are divided in two parts:
62/76 HHS 46-017564 Revision 28

• Decentering of corner blades

• Compliance of octagonal X-ray field
1. Decentering of corner blades
a. From “Formulas for Indirect Test for Innova / Discovery / Allia / Optima” procedure, recall the
following measurements:
• Actual collimator gain = Cg
• Monitor Image width
Also recall the following measurement from 3.5.1: image rotation angle θ.
b. Record new collimator gain with 4 collimator corner blades visible = Cgn’.
c. Record SID.
d. Record selected FOV (12 cm for 30 cm detector and 16 cm for 40 cm detector).
e. Compute G, which is the magnification factor between receptor plane and monitor plane.
G = FOV selected size / Monitor Image width
f. Activate Head up display mode (Rotation button is highlighted).
g. Press Fluoro switch. A figure similar to Figure 9-9 Octagonal X-ray field to measure corner
blades values: c1’, c2’, d1’ and d2’ on page 57 is displayed on the monitor.
9
h. Measure discrepancies for octagonal X-ray field:

Make measurements c1’, c2’, d1’ and d2’ in cm on monitor. Refer to Figure 9-9 Octagonal
X-ray field to measure corner blades values: c1’, c2’, d1’ and d2’ on page 57.
i. Deactivate Head up display mode (Rotation button is not highlighted).
j. Press Fluoro switch. A figure similar to Figure 9-10 Square X-ray field to measure
rectangular blades values: c1, c2, d1 and d2 on page 58 is displayed on the monitor.
k. Measure discrepancies for square X-ray field:
Make measurements c1, c2, d1 and d2 in cm on monitor. Refer to Figure 9-10 Square X-ray
field to measure rectangular blades values: c1, c2, d1 and d2 on page 58.
l. Compute dx and dy which are the coordinates of rectangular collimator blades center in
longitudinal and lateral directions of the square X-ray field.
Figure 9-13
Figure 9-14
46-017564 Revision 28 HHS 63/76

m. Compute dx’ and dy’ which are the coordinates of corner collimator blades center in
diagonal directions of the square X-ray field.
Figure 9-15
Figure 9-16
n. Compute δx and δy, which are the decentering of corner blades center with the rectangular
blade center in diagonal directions of the square X-ray field.
Figure 9-17
Figure 9-18
o. Check decentering of corner blades:

If abs( δx ) > 5.5 mm or abs( δy ) > 5.5 mm, there might be a problem with the collimator.
Verify the compliance of octagonal X-ray field.
p. Store results and computation for analysis Mini-Troubleshooting and continue the
computations in next part.
2. Compliance of octagonal X-ray field
a. From “Formulas for Indirect Test for Innova / Discovery / Allia / Optima”, recall the following
measurements:
• Discrepancies at detector level: c1r, c2r, d1r and d2r for all FOVs and SIDs
b. From “Decentering of corner blades” recall the following measurements:
• Monitor size
• Actual collimator gain (Cg) and new collimator gain value (Cgn’)
• Discrepancies for octagonal blades at monitor level: c1’, c2’, d1’ and d2’ for smaller FOX
and SID max.
• Coordinates of rectangular blades center: dx and dy
• Coordinates of corner blades center: dx’ and dy’
In the following steps, some computations will be done with these results. The coordinates
of the center of corner blades will be computed in several different coordinate systems, to
deduce the localization of corner blade center at the position of the gantry (LAO = 90°; CAU
= 45°) where the measurements of rectangular blades compliance check have been made.
64/76 HHS 46-017564 Revision 28

The B1 coordinate system is rotated by angle –θ with the system B2 where measurements
have been made for corner blades coordinates (dx’,dy’).
The A1 coordinate system is a translation of B1 system. The translation is defined by the
measurements of the rectangular blade centers in B1 (LAO = 0°; CAU = 0°) and in A1 (LAO =
90°; CAU = 45°).
The A2 coordinates system is rotated by angle θ with the A1 system. This will help to
deduce the compliance of octagonal X-ray field at (LAO = 90°; CAU = 45°) gantry position.
c. Compute center coordinates of corner blades in B1 system.
Figure 9-19
Figure 9-20
d. Compute center coordinates of corner blades in A1 system.
Figure 9-21
9

Figure 9-22
e. Compute center coordinates of corner blades in A2 system.
Figure 9-23
Figure 9-24
f. Redo Step 2.d and Step 2.e computations for all FOVs and all SIDs (only c1r, c2r, d1r and d2r
values change).
g. Deduce corner blades alignment at gantry positioning LAU = 90°; CAU = 45°.
i. For FOV3, compute FOV width and length at detector plane and with actual collimator
gain, for octagonal X-ray field, with the following formulas:
Figure 9-25
46-017564 Revision 28 HHS 65/76

Figure 9-26
NOTE
FOV selected Detector size - 30 cm Detector size - 40 cm

FOV0 30 40
FOV1 20 32
FOV2 16 20
FOV3 12 16
ii. For FOV0, FOV1 and FOV2, compute FOV width and length at detector plane and with
actual collimator gain with the following formulas (n = 0, 1 and 2):
Figure 9-27
Figure 9-28
iii. Compute discrepancies c1r’, c2r’, d1r’ and d2r’ for all FOVs and all SIDs:
Figure 9-29
Figure 9-30
Figure 9-31
Figure 9-32
iv. Interpret results, test is “pass” if:

For all FOVs and all SIDs, X-ray field versus image reception area discrepancies match
following criteria:
• abs(c1r’) + abs(c2r’) < 2.8%*SID
• abs(d1r’) + abs(d2r’) < 2.8%*SID
• abs(c1r’) + abs(c2r’) + abs(d1r’) + abs(d2r’) < 3.8%*SID
Actual versus displayed FOV:
66/76 HHS 46-017564 Revision 28

• abs(FOV’ length – FOV) < 1% SID

• abs(FOV’ width – FOV) < 1% SID
If any test is failed refer to Mini-Troubleshooting Guide on page 58.
Finalization
46-017564 Revision 28 HHS 67/76

10
10 Image Overlap Test for Fixed Cones or
Cylinders
10.1 REG0087 - Image Overlap Test for Fixed Cones or

Cylinders

ments

The X–Ray field may not overlap the - -
edges of the receptor.
The FDA actually permits overlap of - -
the X–Ray field provided the field di-
mensions are not greater than the
receptor dimensions and the centers
are aligned within 2% of the SID.
The procedure below, and the data
record form, provide for this possibil-
ity.
Fixed cones and cylinders may only be used at a fixed SID and with a single image receptor size. If a
customer desires to use 14” x 17” cassettes in both the lateral and longitudinal orientations, (as for
certain chest work), they must use a manual collimator at the very least.
Procedure
1. If applicable, align X–Ray source to receptor using normal operator’s procedures.
2. Insert a loaded cassette (or advance a film), make an exposure and process it.
3. If the image meets the requirements above, you’re done. If the image does not meet the
requirements, you have the option of readjusting the system or performing the test starting
with Step 4.
4. Attach the Light to X–Ray Field Test Pattern (approximately centered) to the end of the cone or
cylinder. Attach a loaded vinyl cassette to the pattern.
5. Insert a loaded cassette (or advance a film), make an exposure and process it.
6. Draw diagonals to find the center of the image on the vinyl cassette film. Read the grid
coordinates of this point using the scales on the image.
7. Transfer the center to the receptor film using the grid coordinates obtained in Step 6. This is the
center of the X–Ray field at the receptor. Measure the center to center misalignment of the large
film. Enter misalignment onto form (.6” in the example).
8. Measure the length of an image segment on the small film and measure the corresponding
segment on the large film. Enter the data on the form.
46-017564 Revision 28 HHS 69/76

10.1 REG0087 - Image Overlap Test for Fixed Cones or Cylinders Collimator Tests
9. Measure the overall image size on the small film and enter data onto form.
Figure 10-1 Cone/Extension Cylinder to Cassette Test
NOTE
The units must be consistent: if the cassette is English, then all measurements
should be made in inches. In the above example the .6” center misalignment causes
the field edge to fall off one side of the receptor, so the alternate test is performed.
Since the calculated field size is less than the receptor nominal size, the system
passes the test.
Finalization
70/76 HHS 46-017564 Revision 28

11
11 Collimator Light Field Intensity
11.1 REG0088 - Collimator Light Field Intensity


ments

Approved Light me- 1 - - -
ter must have an ac-
curacy of 5% or bet-
ter.
Fluke Digital Multi- 1 - - -
meter on the 200V
scale or equivalent.
Requirements
1. The average illumination at a distance of 100 cm (39.37”) from the focal spot shall be no less
than 15 foot candles (160 lux). Rejection limit is 16 foot candles (170 lux).
2. GE Model 214 light meter must not be used.
3. Test data may be entered into the Laptop 3382 spreadsheet program, or if this is not available,
it may be recorded in form 3382 found in 46–017566, HHS FORMS, COMPLETING THE FDA 2579
AND GE DATA RECORD FORMS.
4. The recommended method of conducting this test is to use a light meter. However, if no
light meter is available it is possible to make the adjustment by means of the voltage across
the lamp, provided the system does not include a DAP device. (If the system includes a DAP
device, there is no alternative to the light meter test.) The voltage must be measured directly
across the lamp and the minimum values are shown in Table 11-3 Rejection Limits - Voltage
Levels on page 71. Be aware that excessive voltage will result in premature bulb failure and can
also cause darkening of the glass which may reduce light output below the acceptable level. If
the voltage test method is to be used, skip down to the Alternate procedure.
Table 11-3 Rejection Limits - Voltage Levels
Minimum Reading (Lamp Voltage)

Ultranet collimator with GE lamp: 23.0 VAC + meter tolerance
Ultranet collimator with Philips lamp: 21.5 VAC + meter tolerance
AMX collimator: 20.0 VAC + meter tolerance
Siemens collimator: 22.2 VAC + meter tolerance
Eclipse Proteus Collimator 13.4 VDC + meter tolerance
46-017564 Revision 28 HHS 71/76

11.1 REG0088 - Collimator Light Field Intensity Collimator Tests

Low output Lamp, Mirror, Mylar window dirty or discolored.
Lamp voltage low. Refer to Table 11-3 Rejection Limits - Voltage Levels on page 71.
Mirror in backwards.
Supply cable too long.
Faulty collimator bulb.
Faulty lamp socket.
Procedure
1. Verify that line compensator on the generator is properly adjusted before any light field tests
are started.
2. Place Light Meter on table top with sensor directed toward Light Source.
3. If the system includes a DAP device, make sure it is in the beam. This device will attenuate the
light output slightly, and its effect must be taken into account in all brightness measurements.
4. Adjust Focal Spot to Light-Meter-Sensor distance to 100 cm (not SID of 100 cm), or to maximum
if maximum is less than 100 cm (refer to illustration below).
Figure 11-1 Test Set-up – Collimator Light Field Intensity
5. Turn on collimator lamp and adjust field size to approximately 10” x 10” (25.4 x 25.4 cm).
6. Place Light Meter in center of each quadrant of the light field.
7. With collimator lamp off, measure Ambient light level. Enter data onto form.
8. With collimator lamp on measure light level of each quadrant. Enter data onto form.
For Sentry, Ultranet, Eclipse and Micromed Collimators
72/76 HHS 46-017564 Revision 28

Collimator Tests 11.1 REG0088 - Collimator Light Field Intensity
If a light meter is not available, set the lamp base voltage to read at least the voltage called for
in Table 11-3 Rejection Limits - Voltage Levels on page 71. But to avoid excessive heating and
degraded component life, do not adjust lamp voltage any higher than necessary. The voltage
must be measured directly across the bulb socket or test points.
11
Finalization
Collimator Light Field Intensity

46-017564 Revision 28 HHS 73/76

Buc 78530 FRANCE
GE Healthcare
HHS
Mammography Tests
46-017565
Revision 3
HHS Mammography Tests
2
LANGUAGE
Revision History
2 Dec. 1, 1997 Revised to include hardcopy form references for third party users. -
Revision History 13
14 Revision History
Table of Contents
1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.1 X-Ray Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.2 Certified Electrical Contractor Statement . . . . . . . . . . . . . . . . . . . . . . 18
1.3 Damage in Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3 REG0100 - Generator Operator Indicators . . . . . . . . . . . . . . . . . . . . . . . . 20
4 REG0101 - Generator mAs Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5 REG0102 - kVp Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

5.4.1 Record Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.4.2 Procedure 1: Non-invasive Divider Only . . . . . . . . . . . . . . . . . . . . . . 23
5.4.3 Procedure 2: Non-invasive Divider used with Dosimeter (Digital Readout) . . . . . . . 27
6 REG0103 - Reproducibility of Exposure . . . . . . . . . . . . . . . . . . . . . . . . . 28

6.4.1 Procedure 1 for exposures made with A.E.C. . . . . . . . . . . . . . . . . . . . 28
6.4.2 Procedure 2 for exposures made without the use of A.E.C. . . . . . . . . . . . . . 29
7 REG0104 - Beam Quality (Half-Value Layer) . . . . . . . . . . . . . . . . . . . . . . . 30

7.3.1 Procedure 1 - Graphical Method . . . . . . . . . . . . . . . . . . . . . . . . . 30
7.3.2 Procedure 2 - Ratio Method . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
8 REG0105 - X-Ray Field to Image Receptor . . . . . . . . . . . . . . . . . . . . . . . 34
1 Safety


OR DEVICES BE USED.
a physician.
AMERICAS W–622
P.O. BOX 414
1 Safety 17



18 1 Safety
2 Introduction
Dedicated mammographic X-Ray systems require field tests and forms that differ from the
other systems described in this manual. This section includes all field tests and sample
forms required for establishing compliance with HHS guidelines; see 46–017566, HHS
FORMS, COMPLETING THE FDA 2579 AND GE DATA RECORD FORMS, Form F3382MM
for mammographic systems. The tests described here require making exposures and
recording data. Review all the tests in this section and plan an efficient test program to
suit the equipment.
2 Introduction 19
3 REG0100 - Generator Operator Indicators

3.1 Personnel Requirements
Required Persons Preliminary Reqs Procedure Finalization

3.2 Overview
Mammographic X-Ray system controls at installation and P.M. calls.
3.3 Preliminary Requirements

3.3.1 Required Conditions

The product of X-Ray tube current and - -
exposure time cannot exceed 600 mAs
per exposure for tube potential equal to or
greater than 50 kVp. This product shall not
exceed 2000 mAs per exposure for tube
potential less than 50 kVp. In the event
that an exposure is terminated by the 600
mAs/2000 mAs backup, manual reset is
required before further automatically timed
exposures can be made. Visual indication
is required that the 600 mAs/2000 mAs
backup has been actuated.
Audible tones are required for radiographic - -
exposure termination.
An X-Ray warning label must be present. - -
Test data may be entered into the Laptop 46–017566, HHS FORMS, -
3382 spreadsheet program, or if this is not COMPLETING THE FDA 2579
available, it may be record in Form 3382. AND GE DATA RECORD
FORMS
3.4 Procedure
1. Verify Automatic Exposure Control reset and visual indication functions upon activation of
the 600 mAs/2000 mAs backup. The test procedure for these functions is covered in
the Functional Test chapter of the appropriate generator or automatic exposure control
service manual.
2. Check for proper operation of the audible tones or buzzers as required by regulations; for
radiographic exposure, make an exposure (no film required).
20 3 REG0100 - Generator Operator Indicators

3. Verify the presence of a warning label bearing the statement WARNING: This x-ray unit
may be dangerous to patient and operator unless safe exposure factors and operating
instructions are observed on the master control.
4. Record Data: Since these are all go/no-go tests, no data need be recorded; however, the
results must be indicated on Form F3382MM.
3.5 Finalization
3 REG0100 - Generator Operator Indicators 21

4 REG0101 - Generator mAs Accuracy


4.2 Overview
Senix, Senographe, and any other controls that have mAs settings, at installation, preventive
maintenance calls, after repair or replacement of mAs or timer circuits, and replacement
of tube units.


When the equipment is connected to an - -
adequate power supply as specified, the
deviation of the tube current/exposure
shall not exceed the limits given in
specifications (see operating manual). If
mA and time are given separately, the mAs
product deviation limit is approximately
the sum of the two.
FORMS
4.4 Procedure
1. Procedures for this test are given in the individual service manual functional check.
2. Record data on Form F3382MM.
4.5 Finalization
22 4 REG0101 - Generator mAs Accuracy

5 REG0102 - kVp Accuracy


5.2 Overview
Application: at installation, periodic maintenance, and repair.

5.3.1 Tools and Test Equipment
Item Qty Effectivity Part# Manufacturer

Keithley meter (if 1 - - -
another meter is being
used then follow the
meter manufacturer’s
instructions).

Specified Accuracy refers to technic - -
accuracy statements made in the product
specification section of operation manuals.
Actual kVp shall match selected kVp - -
within the Specified Accuracy.
FORMS
5.4 Procedure
5.4.1 Record Data
Record the data on Form F3382MM.
5.4.2 Procedure 1: Non-invasive Divider Only

1. Set up the meter with the K-edge pack as shown in Illustrations below. The long axis
of the meter must be perpendicular to the anode-cathode axis of the X–Ray tube
in order to avoid heel effect.
5 REG0102 - kVp Accuracy 23

Illustration 1: Test Setup for kVp Accuracy for Mammographic Systems
Illustration 2: K-edge Pack
2. Select 25 kV, 100 mAs, and Moly filter. Set scope to .05 volts/div., DC. Ground the input
and set trace to the bottom line; then un-ground and set single sweep.
24 5 REG0102 - kVp Accuracy

3. Make an exposure and record the peak voltage (approximately 3 volts, 3.04 volts in
Illustration below). Disregard transient spikes at the edges of the wave form. Also
disregard any single anomalous narrow spike.
Table 1: kVp Accuracy
Control Type: DMR Specified kVp accuracy: +/- 2 %
Instructions reading
waveforms
Selected kVp k-edge pack V K-edge calc.
24 Messages
25 3.04 volts One or more data points result in K-edge
calcs within the range of the K-edge
26 3.04 volts pack. I've chosen 28.3 kVp and dial
setting 28 to work with.
27 3.05 volts
28 3.17 volts 28.3 kVp Please enter linear pack reading
corresponding to this dial setting in table
29 3.28 volts 29.4 kVp below, opposite the >>>. DO IT NOW !
29.4 kVp rejected; too close to pack

limit.
30
Correction 0.5 kVp

Factor:
Selected kVp Linear pak Corrected Int. Bleeder (V) Bleeder kV Comments
kVp calc.
24 0.0 kVp
25 0.0 kVp
26 0.0 kVp
27 0.0 kVp
28 >>> 27.8 kVp 28.3 4.55 volts 28.1 kVp OK
29 0.0 kVp
30 0.0 kVp
35 note 0.0 kVp
40 0.0 kVp
44 0.0 kVp
48 0.0 kVp
NOTE: To avoid problems with baseline drift, all measurements can be referenced to the zero level
which occurs immediately after (NOT BEFORE) the exposure.

4. Increase the kV dial setting by 1 kV and make a second exposure. Enter data on form.
Output must be within .02 volts of the first reading or it will be rejected. This is your
baseline reading.
If the second reading is more than .02 volts higher than the first, then you have entered the
threshold. In this case, repeat the procedure from Step 2 but start with a 24 kV dial setting.
5. Increase the kV dial setting by 1 kV once again and make a third exposure. Enter data on
form. Continue in this manner until the program indicates a K-edge value. If possible,
continue for 1 more exposure.
6. Now that you’ve established the actual kV, replace the K-edge pack with the linear pack.
Reposition the meter as shown in illustration below. Do not disturb the kV dial setting.
Illustration 3: Mammo Pack
7. With the linear pack in place and the meter set up as in Illustration 3 , make an exposure
and record the reading on the line indicated by the program arrow (27.8 in the example).
NOTE: Once the entry is made opposite the arrow, the program will calculate a correction factor and
will apply it to this and all subsequent linear pack readings. It is essential that the linear pack
not be disturbed. If moved, the entire procedure must be repeated from Step 6 .
NOTE: The correction factor can be positive, negative, or zero, and will change each time you move
the meter or test a new unit. You must obtain a new correction each time you perform this test.
8. Fill in data for 24–30 kV dial settings in the lower part of the chart.
9. Make measurements at 40, 44, and 48 kV using the internal divider as the reference.
The Keithley meter is calibrated only for a moly target with a moly filter and must not be
26 5 REG0102 - kVp Accuracy

used on other target/filter combinations. Use the divider readings for other than the
moly/moly combination.
5.4.3 Procedure 2: Non-invasive Divider used with Dosimeter (Digital Readout)

NOTE: Use the second kVp form for this test.
1. Set up the meter with the K–edge pack as shown in Illustration 1 and Illustration 2 . The
long axis of the meter must be perpendicular to the anode–cathode axis of the x–ray tube
in order to avoid heel effect.
2. Select 25 kV, 100 mAs, and the Moly filter.
3. Make an exposure and note the voltage (approximately 3 volts). Do not enter this on
the data sheet.
4. Increase the kV dial setting by 1 kV and make a second exposure. The display will
continue to show output voltage until the output increases by at least .10 volts over the
first exposure. At that point it will begin to read out in kVp.
If the second reading is more than .02 volts higher than the first, then you have entered the
threshold. In this case, repeat the procedure from Step 2 but start with a 24 kV dial setting.
5. Make exposures at dial settings of 27, 28 and 29. At least one of these exposures will
result in a kVp indication on the meter. Record all kVp values obtained in the K-edge
portion of the table. The program will select the optimum setting. Return to the indicated
setting and make another exposure to verify the output.
6. Now that you’ve established the actual kV, replace the K–edge pack with the linear pack.
Reposition the meter as shown in Illustration 3 . Once you have made the exposure
called for in the next step, you must not move the meter for the rest of the tests. If the
meter is moved after the correction factor is calculated, you must go back to Step 5 (and
Illustration 2 ). The kV dial should not have been disturbed since Step 6 . If the dial has
been moved then repeat Step 5 (using Illustration 2 again).
NOTE: The correction factor can be positive, negative, or zero, and will change each time you move
the meter or test a new unit. You must obtain a new correction each time you perform this test
7. Make exposures at 25, 30, and 35 kV dial settings and enter the data. Monitor the
internal divider.
8. Make measurements at 40, 44, and 48 kV using the internal divider as the reference.
The Keithley meter is calibrated only for a moly target with a moly filter and must not be
used on other target/filter combinations. Use the divider readings for other than the
moly/moly combination.
5.5 Finalization

6 REG0103 - Reproducibility of Exposure


6.2 Overview
Application: at installation, preventive maintenance, and repair.


integrate mode equipped
with a mammography probe
6.3.2 Consumables

Plexiglass 4 cm - - -

For any specific combination of selected 21 CRF-J-1020.31 (b1) -
technique factors, the estimated coefficient
of variation (C.V.) of radiation exposures
shall be no more than 0.05. The rejection
limit is 0.045. This requirement holds for
exposures made with and without use of
A.E.C. on all tubes.
6.4 Procedure
6.4.1 Procedure 1 for exposures made with A.E.C.
1. Install the bucky tray and place 4 cm of plexiglass on the image receptor.
2. Install the 13 x 18 cm diaphragm.
3. Select 30 kVp.
28 6 REG0103 - Reproducibility of Exposure

4. Place the probe approximately 65 cm (25.6 in.) from the focal spot.
NOTE: Avoid probe saturation (see 46–017560, HHS TOOLS).
NOTE: Test is applicable at any kVp and mA setting.
5. Record the exposure in mR for each of ten exposures. After each exposure, cycle the
rotor and the technique switches; that is, set the switches to other values and then
return them to the original values.
If the C.V. is greater than half of the rejection limit, the program will direct you to repeat
the test in the non-AEC mode. Otherwise, you may skip the non-AEC test.
6.4.2 Procedure 2 for exposures made without the use of A.E.C.

1. Place the probe approximately 65 cm (25.6 in.) from the focal spot.
NOTE: Avoid probe saturation (see 46–017560, HHS TOOLS).
2. Select 30 kVp and 100 mAs.
NOTE: Test is applicable at any kVp and mAs setting.
4. Record the mR for each of ten exposures. After each exposure, cycle the rotor and
the technique switches; that is, set the switches to other values and then return them
to the original values.
6.5 Finalization
6 REG0103 - Reproducibility of Exposure 29

7 REG0104 - Beam Quality (Half-Value Layer)


7.2 Overview
Mammographic diagnostic source assemblies at installation and whenever replacing tube
unit insert, mylar window, collimator mirror, or any absorption between patient and source.
7.3 Procedure
7.3.1 Procedure 1 - Graphical Method
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, 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.
1. Set the control for 100 mAs, manual mode, and use the 13 x 18 diaphragm.
2. Set up equipment per Illustration below and take exposure readings with zero, 0.1 mm,
0.2 mm, 0.3 mm, etc. of added filtration. Take several exposures at each filter thickness
and obtain an average exposure for each filter. Continue adding filters until the exposure
is well below the 50% level.
Illustration 4: Beam Quality Test (HVL) Setup
30 7 REG0104 - Beam Quality (Half-Value Layer)

3. Repeat the procedure for each indicated target-filter combination. The program will plot
the data, calculate the HVL and advise you of any problems.
7.3.2 Procedure 2 - Ratio Method

NOTE: The ratio method provides no information on the actual HVL and, therefore, cannot be used
to verify compliance with the high HVL limit. The ratio method is no longer recommended.
2. Set the SID to 65 cm (25.6 in).
3. Place 1/8” thick lead plate on the image receptor.
4. Position the equipment as shown in Illustration 4 .
5. Select the moly filter.
6. Set technic factor as follows:
a. Manual mode,
b. 30 kVp,
c. 100 mAs
7. Make an exposure and measure exposure with no added filters. Record reading. This
represents 100% transmission level.
8. Place a total of 0.30 mm aluminum filters on top of the spacer box. Repeat exposure and
record reading.
9. Select the aluminum filter.
10. Set technic factor as follows:
a. Manual mode,
b. 40 kVp,
c. 100 mAs
11. Make an exposure and measure exposure with no added filters. Record reading. This
represents 100% transmission level.
12. Place a total of 0.40 mm aluminum filters on top of the spacer box. Repeat exposure and
record reading.
13. For the DMR unit, repeat the test for the other target/filter combinations indicated in
the data record form.
7 REG0104 - Beam Quality (Half-Value Layer) 31

Table 2: Beam Quality (HVL)
Control Type: DMR Choose method Graphical Ratio

=> method method
note: for the DMR fill out entire table. For other units fill out lines with arrows.
Anode Track Se- Test kV HVL exp. w/o tst exp. w test ratio Com-
lected Filter filt. filt. ments
Filter
>>> Moly 0.03 0.3 30 0.358 0.000 OK
mm mm
Moly Al.
Moly 0.025 0.3 30

mm mm
Rho. Al.
Rhodium 0.025 0.3 30
mm mm
Rho. Al.
>>> Moly 1.0 mm 0.4mm 40
Al. Al.
Rhodium 1.0 mm 0.4mm 40
Al. Al.
Graphical Method: Moly Target - Moly Filter
Added Filter - 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 Instructions
mm
Exposure - mR 1640 1345 1082 930 746 645 550
Relative Exp. 100 82 66 57 45 39 34 28 23 19 HVL: 0.367 ideal

(%) mm data
HVL: 0.358 your

mm data
Illustration 5: Beam Quality (HVL)
32 7 REG0104 - Beam Quality (Half-Value Layer)

7.4 Finalization
7 REG0104 - Beam Quality (Half-Value Layer) 33

8 REG0105 - X-Ray Field to Image Receptor


8.2 Overview
Perform this procedure at equipment installation, and after any repair which might affect
alignment requirements.


The X-Ray field cannot exceed the image - -
receptor size on the left edge, right edge,
or inside wall. The X-Ray field may exceed
the chest wall by a maximum of 1.8% of
the SID. (This test sets the SID to 650 mm;
1.8% of 650 mm is 11.7 mm).
8.4 Procedure
NOTE: The listed procedure was developed in the West Region and is simple and reliable. We
recognize, however, that there are several other methods of making this measurement.
Clicking the macro button will reconfigure the data record to allow direct entry of data from
any of these alternate test methods.
1. Remove previous test equipment from the table, leave Bucky in place.
2. Select manual mode, 25 kV, 6–10 mAs, large spot, moly target, max. SID.
3. Place a loaded cassette in the Bucky. Now pull the cassette back out exactly 20 mm; it
may be necessary to make a mark on the rails or on the table to establish this distance.
4. Expose the film. It may be necessary to defeat the interlock. The chest wall side of the
X–Ray field will fall on the film.
5. Refer to Illustration below. On the processed film, measure the distance between the
chest wall edge of the film and the edge of the image. Enter the measurement onto
the form.
34 8 REG0105 - X-Ray Field to Image Receptor

Illustration 6: X-Ray Field to Image Receptor Alignment
6. Make additional exposures as above with the small focal spot and with the rhodium track
(DMR unit only), to ensure that the unit meets the spec under all conditions. Refer to the
individual service manuals for recommended values of overlap.
7. Make an additional exposure with the cassette in the normal position, and verify the
X–Ray field is fully contained on the film on the other three sides.
8.5 Finalization
8 REG0105 - X-Ray Field to Image Receptor 35

36 8 REG0105 - X-Ray Field to Image Receptor

78530, Buc
FRANCE
GE Healthcare
HHS
Forms, Completing the FDA 2579 and GE Data
Record Forms
46-017566
Revision 8
HHS Forms, Completing the FDA 2579 and GE Data Record Forms
2
LANGUAGE
Revision History
1 Apr. 30, 1996 Multiple updates reflecting changes in FDA 2579 form and Data Record forms. -
2 Dec. 1, 1997 Updated form 3382. Included references to hardcopy form for third party -
users. Resolved SPR BUCge26789 and XRYge24569.
3 Jan 19, 2005 Updated as per SPR EURge16987 (added mGy units alongwith Roentgen -
units) in pages 30 – 34, an 69–70.
4 Feb 15, 2006 Updated as per SPR EURge45188: added section 7 – Ordering Form 3382 -
For Innova Products.
6 July 20, 2007 Updated with Siemens Collimator voltage (PQR 13107847) -
7 Dec. 20, 2007 Converted from Interleaf into e-CLS Platform. -
8 January 25, 2008 Updated per SPR EURge86024. 106
Revision History 13
14 Revision History
Table of Contents
CHAPTER 1 SAFETY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.1 X-Ray Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.2 Certified Electrical Contractor Statement . . . . . . . . . . . . . . . . . . . . 18
1.3 Damage in Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
CHAPTER 2 RECORDING DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

1 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2 Product Locator Form/Cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3 Ordering Form 2579 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4 REG0098 - FDA Form 2579 – Using the On-line Form . . . . . . . . . . . . . . . . . 22
4.3.1 New Installations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.3.2 Gold Seal, Etc. Programs . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.3.3 Replacement Certified Components . . . . . . . . . . . . . . . . . . . . . . 24
4.3.4 Relocations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.3.5 Loaners, Demos, Consignment Units . . . . . . . . . . . . . . . . . . . . . 24
4.3.6 Blank Form Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.3.7 FDA Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5 REG0099 - FDA form 2579 - Using the Hard Copy Form . . . . . . . . . . . . . . . . 27
CHAPTER 3 SAMPLE 2579 FORMS . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

1 Sample 2579 Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
CHAPTER 4 FORM F3382 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

1 Form F3382 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
CHAPTER 5 FORM F3382MM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

1 Form F3382MM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
CHAPTER 6 FORM F3382SS (HARD COPY ONLY) . . . . . . . . . . . . . . . . . . . . 87

1 Form F3382SS (Hard Copy only) . . . . . . . . . . . . . . . . . . . . . . . . . . 87
CHAPTER 7 FORM F3382MX (HARD COPY ONLY) . . . . . . . . . . . . . . . . . . . . 95

1 Form F3382MX (Hard Copy only) . . . . . . . . . . . . . . . . . . . . . . . . . . 95
CHAPTER 8 FORM 3382 FOR INNOVA VASCULAR PRODUCTS . . . . . . . . . . . . . 103

1 Form 3382 for Innova Vascular Products . . . . . . . . . . . . . . . . . . . . . . 103
Chapter 1 Safety
1 Safety


OR DEVICES BE USED.
a physician.
AMERICAS W–622
P.O. BOX 414
Chapter 1 Safety 17



18 1 Safety
Chapter 2 Recording Data

1 General Information
Section 4, REG0098 - FDA Form 2579 – Using the On-line Form and Section 5, REG0099 -
FDA Form 2579 – Using the Hard Copy Form contain information on completing FDA Form
2579 – Report of Assembly of a Diagnostic X–Ray System. This form must be completed
by the assembler (person installing and/or testing certified components) within 15 days of
assembly per Federal Law. See 46-017559 HHS Introduction, Operating Plan and Test
Requirement Tables, chapter Field FDA Compliance Plan, Procedures for details and see
sample completed forms later in this section.
It is expected that the FDA will grant approval for GEHC to submit an electronic facsimile of
FDA form 2579. The electronic version of the FDA form (known as the On–Line FDA form)
will only be available for GEHC employees who have access to the mainframe through the
Field CARES software. As of this writing, the On–Line form is pending approval, and until
such approval is granted, the hard copy FDA 2579 form is the only recognized reporting
vehicle. After approval is granted, the On–Line form will become the preferred reporting tool,
however, the hard copy form will always be an acceptable substitute.
Chapters 4 thru 7 contain copies of the following GE forms:
• Form 3382 – Data Record for HHS Field Tests (Rad., R&F, Vasc., and component
replacement).
• F3382SS – for Stenoscop (presently hardcopy only)
• F3382MX – for AMX Mobile Units (presently hardcopy only)
• Form 3382MM – for Mammography Units
Additional copies are available from A to Z Printing. Place orders via e-mail by completing the
A to Z order form on Common Forms. Old revisions of these forms may be difficult to use.
Check with your Zone Compliance Coordinator or Zone Office for the latest revisions.
Chapter 2 Recording Data 19

2 Product Locator Form/Cards

Product Locator information must be forwarded to headquarters for all products sold by
GEHC. Follow the instructions provided by the Product Locator Administrator. Typically,
changes or additions to the Product Locator file can be accomplished via e–mail and common
forms. Alternatively, submit the Product Locator Installation Report or the Product Locator
cards to Headquarters by mailing to Product Traceability at W–523. Health Care Services
field engineers should submit Product Locator information to specific vendors whenever the
vendor requests this information. (For example: If the vendor includes a Product Locator form
with a product, the form must be completed and returned to the vendor.)
20 2 Product Locator Form/Cards

3 Ordering Form 2579

Federal Form 2579, “Report of Assembly of a Diagnostic X–ray System” may be obtained
free of charge from:
Consolidated Forms and Publications Distribution Center
Washington Commerce Center
3222 Hubbard Road
Landover, Maryland 20785
Request Form CFPDC–1 (the form to order forms) to facilitate future ordering.

4 REG0098 - FDA Form 2579 – Using the On-line Form


4.2 Overview
This procedure applies only to GEMS and Health Care Services field engineers. Use
of the On Line form requires Field CARES software and access to the mainframe for a
communications session. See Section 5, REG0099 - FDA form 2579 - Using the Hard
Copy Form for use of the hard copy form.
AS OF OCTOBER 1997 THE ELECTRONIC 2579 FORM WAS PENDING APPROVAL

BY THE FDA. UNTIL THE ELECTRONIC FORM IS GRANTED APPROVAL YOU MUST
CONTINUE TO SUBMIT THE HARD COPY FORM, AS THIS IS THE ONLY OFFICIAL
DOCUMENT. HOWEVER, YOU ARE ENCOURAGED TO MAKE USE OF THE ELECTRONIC
FORM AS A METHOD OF CHECKING THE ACCURACY OF DATA ENTERED ONTO THE
HARD COPY FORM. YOU WILL BE ADVISED WHEN THE FDA GRANTS APPROVAL
OF THE ELECTRONIC FORM.
The 2579 form is available on-line, and can be downloaded in a partially completed state, or
initiated from scratch using the blank form stored on the laptop. For replacement components
the 2579 is generated automatically by a laptop resident program.
Provided there is an FDO number (920, 960, or 970 series), the mainframe will generate a
2579 form and will attempt to complete the form.
This section covers completion of the on-line 2579 form for:
• New Installations (refer to Section 4.3.1 )

• Gold Seal, Etc. Programs (refer to Section 4.3.2 )
• Replacement Certified Components (refer to Section 4.3.3 )
• Relocations (refer to Section 4.3.4 )
• Loaners, Demos, Consignment Units (refer to Section 4.3.5 )
4.3 Procedure
4.3.1 New Installations
Refer to the Chapter 3, Section 1, Sample 2579 Forms in Chapter 3.
1. From Field CARES click menu item FORMS and select FDA FORM.
2. To download a form click the [download request] button.
3. Enter the FDO number in the exact format shown, 10 digits with leading zero and no
spaces or dashes. Click [SAVE]. You may request multiple FDOs by clicking [SAVE] after
each new entry. When finished, click [EXIT]. The requested FDO number(s) will be listed
22 4 REG0098 - FDA Form 2579 – Using the On-line Form

on the screen, and will be downloaded during the next communications session. A list of
downloaded forms will appear on this screen following a communications session.
NOTE: The form should not be downloaded till all certified components have been shipped. In
some cases the form may not exist, (FDO not listed in PL system). The information on the
downloaded form describing certified components may be incomplete (not all items were
entered onto PL system); or some certified items on the downloaded form may appear in the
wrong box (incorrect FDA code assigned to model number).
NOTE: If the requested form has previously been downloaded, processed, and uploaded, (by you or
any other Field Engineer) it will not be available for download.
4. If the form fails to download after two or three tries, you will have to create the form from
scratch. In this case refer to Section 4.3.6 .
5. To process a downloaded form re–enter FIELD CARES, select FDA FORM from the
FORMS menu, cursor select the desired 2579 form, and click the [VIEW/EDIT] button.
NOTE: Most of the required fields will have been filled in by the mainframe. Depending on the
accuracy of product locator there may be missing or incorrect items.
6. A pull down menu provides names, addresses, & phone #s of ZCEs. Select your ZCE;
this selection will become the default.
7. Click [Memo] to view messages from, or send messages to ZCE. Click [Exit] to return.
8. Fill in the data as per standard, hard copy 2579.
NOTE: Use F1 to view Help screens (position cursor on field, press F1). The [Help] button provides
overall information, including complete operating instructions.
9. Click the [COMPONENTS] button to edit BLDs, Tables, and CT Gantry.
NOTE: The manufacturer, and date manufactured will not appear for vendor- supplied items. Obtain
this information from the rating plate and enter in COMPONENTS window.
10. Click the [COMMENTS] button to edit items in this area of form.
11. Form can be saved, without flagging for upload, by clicking [Save].
12. When form is complete click [Complete]. Program will detect missing data and return you
to proper field before permitting the Complete operation to be executed.
NOTE: If Y appears in the Complete field (on 2579 request screen), form will be uploaded during
the next comm. session. If upload fails, then Y will be deleted. Once a form has been
successfully uploaded no further changes are possible except by the ZCE. Form cannot be
downloaded a second time once it has been uploaded.
4.3.2 Gold Seal, Etc. Programs

The mainframe will generate a 2579 form for Gold Seal, Silver Seal, etc., only if a 920,
960, or 970 series FDO number is generated. On such forms there is a low probability of
the information being complete; but at least the customer and Zone office information will

be complete. Future program upgrades may improve the situation for such cases. If the
mainframe has not generated a 2579 form use the Blank Form option (refer to Section 4.3.6 ).
4.3.3 Replacement Certified Components

2579 forms for certified replacement components are self–generating on the laptop. A
database of certified component model numbers, including T3 items, is loaded onto the
laptop as part of the FIELD CARES software package. When the FE closes a dispatch,
the laptop program looks for parts numbers used on the dispatch and compares any part
numbers found to the database of certified component part numbers. If a match is found,
the laptop program will generate a 2579 form, copying customer name, address, and part
information onto the form. A message will advise the FE of the newly created form. If the
FE fails to process and upload the form within 5 days after creation mail messages will
be sent to the Zone Compliance Engineer.
NOTE: If the laptop fails to create a 2579 form for a certified component, you must complete the
2579 by using the Blank Form option (refer to Section 4.3.6 ).
1. When the laptop indicates that a 2579 form has been created for a certified replacement
component you must access the new form by selecting the menu item FORMS from
FIELD CARES and then selecting FDA FORM. The new form will be listed on the first
screen under the name of the customer.
2. Cursor select the form and click the [VIEW/EDIT] button.
3. Review the information on the form and correct if necessary. You will need to enter the
model and serial numbers of the master control. If you have already left the site without
noting the master control model/serial number and you do not expect to return within
the next 5 days you may click the [COMPLETE] button and the form will be uploaded
during the next communications session. The mainframe will attempt to insert the master
control model and serial numbers for you. However, be advised that if the mainframe
cannot determine the master control information, you may receive a call from your Zone
Compliance Engineer.
If the mainframe has not generated a 2579 form use the Blank Form option (refer
to Section 4.3.6 ).
4.3.4 Relocations
The mainframe will generate a 2579 for a room relocation only if a 920, 960, or 970 series
FDO number is generated, and only if material is shipped on that FDO. If the mainframe has
not generated a 2579 form use the Blank Form option (see Section 4.3.6 ).
4.3.5 Loaners, Demos, Consignment Units

1. Loaners: Whenever a loaner component is installed, one of the labels below must be
attached to and conspicuously displayed on the component. It is not necessary to file
a 2579 for a true “Loaner” component.
A loaner component must be just that, something installed temporarily in place of a similar
component that was removed for repair. Demo or Consignment units do not qualify, and
you must submit a 2579 form for these units. Although an AMX might qualify as a loaner,
if it was a temporary replacement for another AMX that was removed for repair (and will

be returned when repaired), you may find that local inspectors will require a 2579. It’s
best to file a 2579 even for a loaner AMX.
State requirements vary widely, and some states will require reporting each time
the unit is moved. Check with your local health agency for specific state or city
requirements.
2. Demos or Consignment Units: You must file a 2579 form for these units. However, they
generally need be reported only the first time they are installed. You will need to use the
blank form option (see Section 4.3.6 ) to report such items. Use the 777 series FDO#
described in the blank form option. Enter your office address as the Equipment location.
In the comments section note that the unit is a demo or on consignment. Your office must
maintain records showing where the unit is currently installed. When the unit is relocated
to another site, it is not necessary to file another 2579 form unless you disassembled
HHS sensitive components (thus requiring re-assembly and re-testing). Keep a copy of
the original 2579 form with the unit, and note on the outside that the copy is inside.
Labels for Loaner Components:
TEMPORARILY INSTALLED COMPATIBLE COMPONENT
This certified component has been assembled, installed, adjusted and tested by me according to the instructions provided by the manufacturer.
Company Name
Company Address
Assembler' Name
Signature Date
TEMPORARILY INSTALLED NON-COMPATIBLE COMPONENT
This certified component has been assembled or installed by me but could not be assembled, installed, adjusted and tested according
to the instructions provided by the manufacturer because other already existing components of the system do not meet the compatibility
specifications of the manufacturer of the certified component being installed, and there are no commercially available certified components of
a similar type which are compatible with the system.
Company Name
Company Address
Assembler' Name
Signature Date
4.3.6 Blank Form Option

For any case where a 2579 form is required and the form has not been created automatically,
you must use the Blank Form option on the laptop.
1. From FIELD CARES select menu item FORMS and then select FDA Form.

2. Click the [Blank Form] button on the next screen.
3. If the GE office address fields are blank use the pull down menu in that area and select
your Zone Compliance Engineer (ZCE). This will become the default.
4. Complete the form using the examples in Chapter 2 as a guide. The program will not
allow you to mark a form as Complete until all essential information has been entered.
NOTE: Help screens are available for many fields; simply place the cursor on the field and press F1
to see specific Help information. The [Help] button provides overall information, including
complete operating instructions.
5. You may save an incomplete form for completion later.
6. You should always provide the master control model and serial numbers.
NOTE: If you have already left the site without noting the master control mod./sn and you do not
expect to return within the next 5 days you may click the [COMPLETE] button and the form
will be uploaded during the next communications session. The mainframe will attempt to
insert the master control model and serial numbers for you. However, be advised that if the
mainframe cannot determine the master control information you may receive a call from
your Zone Compliance Engineer.
7. For certified replacement components, the laptop will generate a dummy FDO # in the
format 9999xxxxxx where x is your employee ID. Do not modify this number.
4.3.7 FDA Codes

On occasion an item will be assigned an incorrect FDA code, or no code at all. If in doubt,
use the following list to determine the correct FDA code.
• A. Beam Limiting Device (coll., mammo diaph., see N for mag. device)
• B. Tube Housing Assembly (including mammo, see “N” for others)
• E. Tube Housing Assembly with Hi Volt. Gen. (Dental machines only)
• F. X–ray Controls (master control, see “N” for others)
• H. High Voltage Generator (H V Xfmr.)
• I. Image Intensifier (the complete assembly, not the tube)
• J. Tables (tables & tops but not CT cradle or extender (non-certified))
• K. Cradle (vascular cradle, but not CT as these are non-certified)
• L. Vertical Cassette Holders (VCH, V. Buckys, see “N” for mammo bucky or mammo
cassette holder)
• M. Film Changer
• N. Other, includes C, D, G, P, and R (power units, mammo mag devices, cassette
holders and buckys, Polarix & Stenoscop tubes, etc.)
• S. Spot Film Device (also the cassette holder of a Stenoscop)
• T. CT Gantry
4.4 Finalization

5 REG0099 - FDA form 2579 - Using the Hard Copy Form


5.2 Overview
Refer to the sample forms following this chapter.
5.3 Procedure
1. The customer address is the equipment location; you must provide a phone number.
2. The assembler address (Zone Filing Office) is the location where file copies of the 2579
form are maintained; you must provide a phone number.
• GEHC and HCS FEs – always enter GE MEDICAL SYSTEMS as the company
name.
• GEHC FEs – use the address of one of the five Zone Compliance Engineers.
• HCS FEs – use the Brentwood, TN address.
3. Indicate if this is a new room installation, a reassembly (relocation), a replacement

component, or an addition to an existing system (e.g. vertical cassette holder added to
existing system).
4. Indicate the function(s) of the system.
5. Indicate if the system is stationary or mobile (equipment in a van is considered mobile).
6. Enter the location of the master control (room name) so the FDA can find the equipment if
they visit the site.
7. Enter the Assembly date; this is the date the equipment was released to the customer.
8. In all cases, even if this is simply a component replacement, you must provide all the
requested information on the master control.
9. Enter the manufacturer’s name, model number, and manufacturing date of any BLDs
(including diaphragms), tables, table tops, or CT gantries that you install.
10. Indicate the quantity of any other certified components that you install.
11. If you install a certified component that is not listed on the form (such as a bucky,
magnification device, AEC module, etc., indicate the quantity under “OTHER” and
describe the device in the COMMENTS section. Do not report model and serial numbers
in COMMENTS.
12. Sign and date the form. Be advised that if the signature date is more than 15 days beyond
the assembly date, you are in violation of Federal Law.

13. Mail the 2579 form to your Zone Compliance Engineer (HCS FEs – mail to Brentwood,
TN); non–GEMS users – mail each section to the agency listed at the bottom of the
section.
5.4 Finalization
28 5 REG0099 - FDA form 2579 - Using the Hard Copy Form

Chapter 3 Sample 2579 Forms

1 Sample 2579 Forms
Chapter 3 Sample 2579 Forms 29

Illustration 3-1:
30 1 Sample 2579 Forms

Illustration 3-2:

Illustration 3-3:

Illustration 3-4:

Illustration 3-5:

Illustration 3-6:

Illustration 3-7:

Illustration 3-8:

Illustration 3-9:

Illustration 3-10:

Illustration 3-11:

Illustration 3-12:

Illustration 3-13:

Illustration 3-14:


Chapter 4 Form F3382

1 Form F3382
Table 4-1: Customer Information Page
1 - Click [Start] button, enter data in items 1 and 2, then click [done].
Customer name:
City and State:
System ID:
FDO: (use dash)
Room Name:
Field Tests done by: on
Factory Tests by: on
2 - File can be saved under these names----> a .XLS
Option “d” opens window for custom entry. b .XLS

c .XLS
Save file w name d d developing 6.3
Table 4-2: Field Test Equipment Used
Item Manufacturer Model No. Serial No. Cal. Due Date

Radiation Meter MDH 2025
Survey Meter Victoreen 470 A
Non-invasive kV mtr Keithley 35080A
Light Meter Digaphot
DVM
HHS Test Kit GEHC 46-303879G1 or
46-315694G1
mA Meter
mAs Meter
Oscilloscope
HV Divider
NOTE: Enter dates as shown: 8/16/95
YOU MUST SPECIFY ROOM EQUIPMENT BELOW
Chapter 4 Form F3382 45

Table 4-3: Equipment Selection Page
Use any letter to select, use delete or backspace to erase!
Controls
Advantx_MP
Advantx_LFX When finished selecting all room
equipment, you must click large
Advantx_HF button below to set up correct
accuracy chart.
MP_phase_4
Future
Future
MPG_or_MPH
MPX
MST Tube focal spot configurations
MVP
MVP_Micro norm.f.s. biased f.s.
Future x lg./sm. none
Phasix “Advantx HF” same as “SCPU” x lg./sm. 1 (multi ma sta.)
Silhouette “Silhouette” means 1 or 3 phase lg./med./sm. 3 (1 ma sta. each)
Silhouette_SE “Silhouette_SE” means stored energy
Future
selection_error
R & F Tables and Tops Remote Tables
RFX/SFX Monitrol IBIS Future Prestilix 1600 / S / SAV

4 w curvd Prestilix 1600X / 1690
4 way flat Televix
2 way flat
future
This section is irrelevant if there is no SFD

System configuration / features
Rad only sys. Tilt C system Third Rad. Tube
Vascular sys. Digital Rad. mode Multi-focus tube
Additional system components
SFD Auto. Overhead Coll.

Remote Table Manual Collimator
Table bucky (not remotes) Cone or Exten. Cylinder
Wall Bucky or Cass. hldr. Gantry-Mtd.Film Changer
46 1 Form F3382
GENERATOR OPERATOR INDICATORS
yes no n/a
Tube unit indicator lights
AEC reset
Tones and buzzers
50 kVp mammography limit
Warning label present
Tech. factors indicated prior to exposure
FLUORO AND TOMOGRAPHIC TIMERS

yes no n/a
Fluoro timer works properly
Tomo time selector works properly

TECHNIQUE ACCURACY / INDIRECT EXPOSURE LINEARITY - RAD TUBE
For 10 - 25 mA stations I will enter: X mA mAs

Control Type: Check:
kV dial setting 60 kVp 60 kVp 60 kVp 60 kVp 60 kVp 60 kVp 60 kVp 60 kVp
1. sm. mA station 10.0 12.5 40.0 50.0 80.0 100 160 200
2. exp. time (ref.) 2.000 1.600 0.500 0.400 0.250 0.200 0.125 0.100
3. timer limits (ref.) 1.90 2.10 1.52 1.68 .47 .53 .380 .421 .237 .263 .190 .211 .118 .132 .095 .106
4. kV mA or mAs
1. lg. mA station 250 320 400 500 640 800 1000 1250
2. exp. time (ref.) 0.080 0.064 0.050 0.040 0.032 0.025 0.020 0.016
3. timer limits (ref.) .076 .085 .060 .068 .047 .053 .038 .043 .030 .034 .023 .027 .019 .022 .015 .017
4. kV mA or mAs
1. sm. mA station 10.0 12.5 40.0 50.0 80.0 100 160 200
2. exp. time (ref.) 2.000 1.600 0.500 0.400 0.250 0.200 0.125 0.100
3. timer limits (ref.) 1.90 2.10 1.52 1.68 .47 .53 .380 .421 .237 .263 .190 .211 .118 .132 .095 .106
4. kV mA or mAs
1. lg. mA station 250 320 400 500 640 800 1000 1250
2. exp. time (ref.) 0.080 0.064 0.050 0.040 0.032 0.025 0.020 0.016
3. timer limits (ref.) .076 .085 .060 .068 .047 .053 .038 .043 .030 .034 .023 .027 .019 .022 .015 .017
4. kV mA or mAs
1. sm. mA station 10.0 12.5 40.0 50.0 80.0 100 160 200
2. exp. time (ref.) 2.000 1.600 0.500 0.400 0.250 0.200 0.125 0.100
3. timer limits (ref.) 1.90 2.10 1.52 1.68 .47 .53 .38 .42 .24 .26 .19 .21 .12 .13 .09 .11
4. kV mA or mAs
1. lg. mA station 250 320 400 500 640 800 1000 1250
2. exp. time (ref.) 0.080 0.064 0.050 0.040 0.032 0.025 0.020 0.016
3. timer limits (ref.) .076 .085 .060 .068 .047 .053 .038 .043 .030 .034 .023 .027 .019 .022 .015 .017
4. kV mA or mAs
48 1 Form F3382
TECHNIQUE ACCURACY / INDIRECT EXPOSURE LINEARITY - SF TUBE

1. sm. mA station 10.0 12.5 40.0 50.0 80.0 100 160 200
2. exp. time (ref.) 2.000 1.600 0.500 0.400 0.250 0.200 0.125 0.100
3. timer limits (ref.) 1.90 2.10 1.52 1.68 .475 .526 .380 .421 .237 .263 .190 .211 .118 .132 .095 .106
4. kV mA or mAs
1. lg. mA station 250 320 400 500 640 800 1000 1250
2. exp. time (ref.) 0.080 0.064 0.050 0.040 0.032 0.025 0.020 0.016
3. timer limits (ref.) .076 .085 .060 .068 .047 .053 .038 .043 .030 .034 .023 .027 .019 .022 .015 .017
4. kV mA or mAs
1. sm. mA station 10.0 12.5 40.0 50.0 80.0 100 160 200
2. exp. time (ref.) 2.000 1.600 0.500 0.400 0.250 0.200 0.125 0.100
3. timer limits (ref.) 1.90 2.10 1.52 1.68 .475 .526 .380 .421 .237 .263 .190 .211 .118 .132 .095 .106
4. kV mA or mAs
1. lg. mA station 250 320 400 500 640 800 1000 1250
2. exp. time (ref.) 0.080 0.064 0.050 0.040 0.032 0.025 0.020 0.016
3. timer limits (ref.) .076 .085 .060 .068 .047 .053 .038 .043 .030 .034 .023 .027 .019 .022 .015 .017
4. kV mA or mAs
1. sm. mA station 10.0 12.5 40.0 50.0 80.0 100 160 200
2. exp. time (ref.) 2.000 1.600 0.500 0.400 0.250 0.200 0.125 0.100
3. timer limits (ref.) 1.90 2.10 1.52 1.68 .475 .526 .380 .421 .237 .263 .190 .211 .118 .132 .095 .106
4. kV mA or mAs
1. lg. mA station 250 320 400 500 640 800 1000 1250
2. exp. time (ref.) 0.080 0.064 0.050 0.040 0.032 0.025 0.020 0.016
3. timer limits (ref.) .076 .085 .060 .068 .047 .053 .038 .043 .030 .034 .023 .027 .019 .022 .015 .017
4. kV mA or mAs

DIRECT LINEARITY OF EXPOSURE (alternate method)
Instructions - 46-017561 HHS Control & Tube Assembly Tests, chapter Indirect Linearity
Notes: Use this test only if indirect linearity test fails. Complete an entry for each failed pair of mA stations. If you don't enter a time
the program will assume 20 mAs.
mA stations that failed mA (first)
indirect linearity and time
selected mAs 20.0

exposure
mA (2nd)
time
selected mAs 20.0
exposure
coef. of var.
selected mAs 20.0

exposure
mA (2nd)
time
selected mAs 20.0
exposure
coef. of var.
selected mAs 20.0

exposure
mA (2nd)
time
selected mAs 20.0
exposure
coef. of var.
50 1 Form F3382
AEC MAXIMUM mAs

Instructions - 46-017561 HHS Control & Tube Assembly Tests, chapter Technique Accuracy - Manual mA Accuracy for
Innova 21xx/31xx/41xx
maximum mAs requirements met yes no n/a yes no n/a
(Does not apply to IIs) @ 600 mAs @ 2,000 mAs
AEC MINIMUM EXPOSURE TIME

Instructions - 46-017561 HHS Control & Tube Assembly Tests, chapter Technique Accuracy - KV for Innova 21xx/31xx/41xx
Minimum exposure time requirement met for each sensing area of: yes no n/a
Table Bucky Detector
SFD Detector
Wall unit detector
REPRODUCTIBILITY OF EXPOSURE
Instructions - 46-017561 HHS Control & Tube Assembly Tests, chapter Technique Accuracy - mAs
Note 1: Be sure to cycle rotor and technique switches between exposures.
kVp mA SEC. exposure - mR avg. s.d. c.v.
TOMO 80 200
AEC #1 80 200
AEC #2 80 200
AEC #3 80 200
AEC #4 200
non-AEC 80 200 0.1
BEAM QUALITY (HALF VALUE LAYER)
Instructions - 46-017562 HHS Beam Quality Test, chapter Beam Quality (Half Value Layer)
Radiation readings Ratio Extra filtration mtd.
with standard with standard with / without in beam to obtain

absorber in (or out) absorber out (or in)
ratio, (fixed filter).
Fluoro tube
Rad 1
Rad 2

FLUORO ENTRANCE EXPOSURE RATE

Instructions - 46-017562 HHS Fluoro System Tests, chapter Fluoro Entrance Exposure Rate
Note 1: For HHS record highest exposure rates in all modes. Also record the mA corresponding to the maximum exposure rate. You
should verify kVp accuracy if this has not already been done. You may find it useful for future service to record additional
data as allowed by the tables on the next page.
Note 2: If the system has KV override, only one entry, at 120 kVp in automatic mode, will be shown.
Note 3: Rejection limit 5.0% meter accuracy max. uncorrected meter reading: 9.20 R/min.
based on:
70
F (to nearest 5 ) 80 mGy/min.
800 Ft. above see level (to nearest 250')
Indicate system type. Program will define setup, and flag required columns on data table.
Remote tables.
RFX/SFX and similar tables.
LU-A, MLX, LP, and similar systems w SID comp. and moveable XRT carriage.
LU-C, LC, AFM, CFM, and similar systems with SID comp. and fixed XRT carriage.
Vascular sys. w tube mounted under a fixed table. Top may or may not elevate, tube does not.
Vascular sys. w tube mounted under a fixed table. Tube elevates, top may or may not elevate.
Lateral Fluoricon 300 and other archaic lateral systems w two independent suspensions only.
Selected FL kVp corresponds to displayed kVp. yes no n/a
Actual FL kVp within tolerance yes no n/a
Conversion of Roentgen Units to Gray units:
R x 8.76 / 1000 Gy
Example:
1. 3 x 8.76 / 1000 Gy = 26.3 mGy
2. 10 x 8.76 / 1000 Gy = 87.6 mGy
52 1 Form F3382
FLUORO ENTRANCE EXPOSURE RATE (continued)
CONVENTIONAL FLUORO (INTERLACED)
Note: 1. White Cells not required, but may be valuable for future reference.
Note: 2. If HV is checked w bleeder (NI meter preferred), be sure to remove it when mA and exp. data is recorded.
Selected Diale D kVp Actual kVp XRT at fixed or min. SID XRT at max SID
mA mode
Intensifier at Intensifier at II 30 cm from Intensifier at Intensifier at II 30 cm from
min SID max SID Isocenter min SID max SID Isocenter
mA mGy/ mA mGy/ mA mGy/ mA mGy/ mA mGy/ mA mGy/
min min min min min min
max., man 60
80
AP plane 100
120
max, auto 60
120
max., man 60
80
LAT plane 100
120
max, auto 60
120
PULSCAN/DX (PROGRESSIVE)
Selected Diale D kVp Actual kVp XRT at fixed or min. SID XRT at max SID
mA mode
Intensifier at Intensifier at II 30 cm from Intensifier at Intensifier at II 30 cm from
min SID max SID Isocenter min SID max SID Isocenter
mA mGy/ mA mGy/ mA mGy/ mA mGy/ mA mGy/ mA mGy/
min min min min min min
max., man 60
80
AP plane 100
120
max, auto 60
120
max., man 60
80
LAT plane 100
120
max, auto 60
120

Conversion of Roentgen Units to Gray Units: (R x 8.76) / 1000 Gy
Example: 3 R = 3 x 8.76 / 1000 Gy = 26.3 mGy
Example: 10 R = 10 x 8.76 / 1000 Gy = 87.6 mGy
PRIMARY BARRIER TRANSMISSION
Instructions - 46-017563 HHS Fluoro System Tests, chapter Primary Barrier Transmission
Illustration 4-1:
54 1 Form F3382
Illustration 4-2:
Example: 3 R = 3 x 8.76 / 1000 Gy = 26.3 mGy
Example: 10 R = 10 x 8.76 / 1000 Gy = 87.6 mGy

UNDERTABLE TUBE LEAKAGE RADIATION
Note 1: Ensure that any supplied lead collimator shields are in place.
Note 2: Not applicable to systems w exposed tube housing, e.g. C-arms.
Illustration 4-3:
FLUORO INTERLOCKS
The Fluoro interlock works YES NO N/A
Example: 3 R = 3 x 8.76 / 1000 Gy = 26.3 mGy
Example: 10 R = 10 x 8.76 / 1000 Gy = 87.6 mGy
56 1 Form F3382
COLLIMATOR FUNCTION
AUTO RAD Collimators yes no
Collimator meets all Functional Checks of Product Manual
Table SID indicator present?
Chest stand SID indicator present
Collimator response time under 5 s?
SID Crossover
When moving downward, collimator goes into non-auto at
When moving upward, collimator goes into auto at
In-table fluoro collimators

yes no
Collimator meets the requirements of 46-017564 HHS Collimator Tests,
Table 3-1.
Vascular collimators
yes no
Collimator permits X-Ray exposure only at the proper SID or SID range.
SID or SID range
Manual collimators
yes no
On-site factory documentation indicates manual collimator is allowed with
this system configuration.

AUTO COLLIMATOR TO TABLE BUCKY (not for remote tables)
Instructions - 46-017564 HHS Collimator Tests

SID - Beam Vert. Indicated Measured err. %SID
SID can be in inches or cm.

y/n
If tube is moved, does actual shift agree w indicator change?
SID - Beam Hor. Indicated Measured err. %SID
in. cm.
Indicated SID: Test pattern: Eng. Met: x
Light to N S E W
X-Ray Field Light Field 12.5 12.5 12.5 12.5 N-S = % SID err.
(beam vertical) X-Ray Field E-W = % SID err.
Center to Center Indicated SID: Centering error
(beam vertical)
error = %SID
Collimator crosshairs shift by: as tube moves over allowable SID range.
N-S E-W
Field Size Indicator Indicated SID: Actual size error = %SID N-S
(beam vertical) Indicator 10.0” 10.0” error = %SID E-W
Above data in inches even if SID is in cm.
N-S E-W
(beam horizontal) Indicator 10.0” 10.0” error = %SID E-W
58 1 Form F3382
AUTO COLLIMATOR TO TABLE BUCKY (continued) (not for remote tables)
Size to size test instructions - 46-017564 HHS Collimator Tests, chapter Fluoro Collimator to Image Intensifier Test, Requirements.
(Beam vertical) Select 3 cassettes, (empty): lat. long. lat. long.

OK to mix English and metric. If the desired
size is not listed, then enter size at bottom of 35 x 43 14 x 17
table, one dimension per cell.
30 x 35 12 x 14
24 x 30 10 x 12
18 x 24 8 x 10
X-ray field measured in: in. cm
Enter SID 1 (smaller): SID 2:
Note: Perform the light / X-ray field ratio test at the first SID!!
lat. long.
Light field size at collimator: units by units
Corresponding X-ray field:
X-ray field to light field ratios:
Format Light Field Calculated XR Field Size errors - % SID

SID lat. long. lat. long. lat. long. lat. long. sum P/F
beam vert.
beam vert.
beam vert.
beam vert.
beam hor.

AUTO COLLIMATOR TO CHEST UNIT, CASSETTE, OR VERTICAL BUCKY STAND


y/n
in. cm.
Indicated SID: Test pattern: Eng. Met:
Light to N S E W
X-Ray Field Light Field 5 5 5 5 N-S = % SID err.
X-Ray Field E-W = % SID err.
(beam horizontal)
error = %SID
(beam vertical, for

tilting VBS only)
error = %SID
N-S E-W
N-S E-W
(beam vertical, for Indicator 10.0” 10.0” error = %SID E-W
tilting VBS only)
60 1 Form F3382
AUTO COLLIMATOR TO CHEST UNIT, CASSETTE, OR VBS (continued)
Size to size test instructions - 46-017564 HHS Collimator Tests, chapter Fluoro Collimator to Image Intensifier Test, Requirements.
Beam horizontal test. See below for beam vertical test if applicable.
Select 3 cassettes, (empty): OK to mix lat. long. lat. long.

English and metric. If the desired size is not
listed, then enter size at bottom of table, one 35 x 43 14 x 17
dimension per cell.
30 x 35 12 x 14
24 x 30 10 x 12
18 x 24 8 x 10
X-ray field measured in: inches cm
Enter most often used SID: If sys. is used at alternate SID, enter here
If this is a tilting VBS, enter vertical SID:
Note: Perform the light / X-ray field ratio test at the most often used SID!!
lat. long.
Corresponding X-ray field size:
Format Light Field Calculated XR Field Size errors - % SID

beam hor.
beam hor.
beam hor.
beam hor.
beam vert.

AUTO COLLIMATOR TO GANTRY-MOUNTED FILM CHANGER

Center to Center Test Instructions - 46-017564 HHS Collimator Tests, chapter Center to Center Test for Film Changers.
Data entered in: inches cm
Enter min. SID: max. SID (enter digital readout with film changer in position)
Centering
SID data % P/F

min.
max.
Size to Size Test Instructions - 46-017564 HHS Collimator Tests, chapter Fluoro Collimator to Image Intensifier Test .
Note: Perform the light / X-ray field ratio test at minimum SID!!
in. cm.
Input plane opening dimen: 33 by 33 x
lat. long.
Corresponding X-ray field size:
Format Light Field Calc. X-Ray Field Size errors - % SID
min. 33.0 33.0 m

max. 33.0 33.0 m
62 1 Form F3382
AUTO COLLIMATOR TO BUCKY ON REMOTE TABLE


y/n
in. cm.
Indicated SID: Test pattern: Eng. Met:
Light to N S E W
X-Ray Field E-W = % SID err.
N-S E-W
Field Size Indicator Indicated SID: 0 Actual size error = %SID N-S
(beam vertical) Indicator 10.0” 10.0” error = %SID E-W
N-S E-W

AUTO COLLIMATOR TO BUCKY ON REMOTE TABLE

Center to Center Test Instructions - 46-017564 HHS Collimator Tests, chapter Center to Center Test for SFD.
cm. in.
Test data is in: inches cm. OK to use inches w metric cass. etc. SID max
SID min
Centering
EXP SID Table Format Cassette data % P/F

Note: You can change cassette type m 1 min Hor. 1 on 1 30 x 24
(English/metric) by changing letter code at extreme
left end of table to e or m. This has no effect for m 2 max Hor. 1 on 1 30 x 24
centering test but is very important on size to size m 3 min Trend. 1 on 1 30 x 24
test below.
m 4 max Trend. 1 on 1 30 x 24
m 5 min Vert. 1 on 1 30 x 24
m 6 max Vert. 1 on 1 30 x 24
m 7 min Hor. 4 on 1 43 x 35
m 8 max Hor. 4 on 1 43 x 35
Size to Size Test Instructions - 46-017564 HHS Collimator Tests, chapter Fluoro Collimator to Image Intensifier Test, Requirements.
X-ray field measured in: inches cm
Note: Perform the light / X-Ray field ratio test at minimum SID!!
Verify the maximum SID Verify min. SID
lat. long.
Light field size at collimator: units by
Corresponding X-Ray field size: units by
X-Ray field to light field ratios:
Note: For the Prestilix 1690 use the 8 on 1 format instead of the 4 on 1. (need 4 exp. for either table).
Table angulation - Horizontal Format Light Field Calculated XR Field Size errors - % SID
EXP SID Format Cassette lat. long. lat. long. lat. long. lat. long. sum P/F
m 1 max 1 on 1 43 x 35 43.0 35.0
m 2 min 1 on 1 30 x 24 30.0 24.0
m 3 max 4 on 1 30 x 24 7.5 24.0
m 4 min 4 on 1 30 x 24 7.5 24.0
m 3 max 8 on 1 30 x 24 7.5 12.0
m 4 min 8 on 1 30 x 24 7.5 12.0
lat.↑
64 1 Form F3382
MANUAL COLLIMATOR

y/n

in. cm.
Indicated SID: Test pattern: Eng. Met: imp.

note
Light to N S E W
(beam vertical) X-Ray Field E-W = % SID err.
error = %SID
N-S E-W
(beam vert. or hor.) Indicator 10.0” 10.0” error = %SID E-W
N-S E-W
(beam hor. or vert.) Indicator 10.0” 10.0” error = %SID E-W

FLUORO COLLIMATOR TO SPOT FILM DEVICE
NOTE: There are four forms below. You need only select one, based on the most commonly used
cassette size at this site, (you can use more forms if you wish).
Magnification films are no longer used. The program calculates magnification from the table
dimensions. You enter only the dimensions of the image of the tabletop film or the image size
from the phosphor tool (2120565).
Illustration 4-4:
66 1 Form F3382
Center to center Test instructions - 46-017564 HHS Collimator Tests, chapter Center to 2 on 1 long. means lat.
Center Test for SFD.
dimension is shorter
Size to size Test instructions - 46-017564 HHS Collimator Tests, chapter Fluoro Collimator to
Image Intensifier Test procedure.
FORM 1 - 8835, 8735, and 8535 SFDs, with 14”x14” or 35 cm x 35 cm cassettes.
Cassette is: Eng. Met- Data is: Eng. Metric

ric
Centering Image Size Calc. field size Size errors - % SID
EXP SID Table Format data % P/F lat. long. lat. long. lat. long. sum P/F
1 min Hor. 1 on 1
2 min Hor. 2 on 1 long
7 max Hor. 1 on 1
8 max Vert. 1 on 1
9 max Trend. 1 on 1
10
11
12
FORM 2 - 8835, 8735, and 8535 SFDs, with 9.5”x 9.5” or 24 cm x 24 cm cassettes.

ric
1 min Hor. 1 on 1
4 max Hor. 1 on 1
5 max Vert. 1 on 1
6 max Trend. 1 on 1

FLUORO COLLIMATOR TO SPOT FILM DEVICE (continued)
Center to center Test instructions - 46-017564 HHS Collimator Tests, chapter Center to 2 on 1 long. means lat.
Center Test for SFD.
dimension is shorter
Size to size Test instructions - 46-017564 HHS Collimator Tests, chapter Fluoro Collimator to
Image Intensifier Test procedure.
FORM 3 - 8835, 8735, and 8535 SFDs, with 10”x12” or 24 cm x 30 cm cassettes.

ric
1 min Hor. 1 on 1
4 min Hor. 2 on 1 lat
5 min Hor. 2 on 1 lat
6 max Hor. 1 on 1
7 max Vert. 1 on 1
8 max Trend. 1 on 1
9
10
FORM 4 - All SFDs EXCEPT the 8835, 8735, and 8535 SFDs, with 9.5”x 9.5” or 24 cm x 24 cm cassettes.

ric
1 min Hor. 1 on 1
2 min Hor. 4 on 1
3 min Hor. 4 on 1
4 min Hor. 4 on 1
5 min Hor. 4 on 1
6 max Hor. 1 on 1
7 max Vert. 1 on 1
8 max Trend. 1 on 1
9 min Hor. other multi
on one
10 min Hor. formats if
provided
11 min Hor.
12 min Hor.
68 1 Form F3382
FLUORO COLLIMATOR TO INTENSIFIER

Minimum field size at maximum SID is less than 2”x2”?: yes no
Not necessary to complete bottom section of page if all answers in table below are “Yes” or “n/a”.
ARE ALL COLLIMATOR BLADES VISIBLE ON MONITOR AT ALL TIMES?
n/a yes no n/a yes no n/a yes no n/a yes no

normal FOV mag. 1 mag. 2 mag. 3 Default “X” will vanish if other
box is marked.
table H, min.
SID
table H, max.
SID
table V, min. Marks in cells
SID
table V, max. will be copied to all related
SID cells.
table T, min.
SID
table T, max.
SID
Complete the bottom section if any answer in the table above is “no”.
Note: Document system configuration that produced worst alignment.
Note: If no default value shows for source to tabletop dist., use 18.5” and set table in lowest position.
SID (enter “min” or “max”, not a num.)
Table angulation, (H, V, or T)
Mode (norm., mag1, etc.)
Source to Tabletop Film Distance 19.4 ins.
Monitor image N. 2.5” S. 2.5” E. 2.5” W. 2.5”
Film image N. S. E. W.
Misalignment as a % of SID N-S: % E-W: % Tot: %

CONE / EXTENSION CYLINDER TO CASSETTE

Note: You may use either the basic or alternative acceptance criteria.
Basic Acceptance Criteria: Image must be fully contained within image receptor.
pass fail
Alternative Acceptance Criteria: (see below 1 & 2)
1. Center to Center Misalignment = 1.8% SID max.
Indicated SID:
Misalignment: %
2. Image dimensions must be no larger than receptor dimensions.
Calculated receptor field size
Receptacle nominal dimensions: x
Segment len. - small film // receptor film // x
Overall image size - small film x
70 1 Form F3382
COLLIMATOR LIGHT FIELD INTENSITY

Acceptance Criteria: minimum of 16.0 FC (170 lux) above ambient
min. 20.0 Vac (Sentry); 21.5 Vac (Ultranet) directly across lamp
Alternate Acceptance Criteria: min. 22.2 Vac (Siemens Collimator)
min.13.4 VDC (Eclipse Proteus collimator)
LIGHT METER TEST

Enter light meter readings in boxes below.
Illustration 4-5:
Data is in: FC (references will self-correct.)
Ambient brightness: FC
Data (each quadrant): FC
min. average req. over ambient: 16 FC
Average brightness over ambient: FC
ALTERNATE VOLTAGE TEST
Collimator Type: (default is Ultranet)
Volts directly across lamp: VAC min. required lamp voltage: VAC
TRACEABILITY
Verify that the necessary information has been sent to the product locator file. YES

TECHNIQUE ACCURACY / INDIRECT EXPOSURE LINEARITY - THIRD RAD TUBE

1. sm. mA station 10.0 12.5 40.0 50.0 80.0 100 160 200
2. exp. time (ref.) 2.000 1.600 0.500 0.400 0.250 0.200 0.125 0.100
3. timer limits (ref.) 1.90 2.10 1.52 1.68 .475 .526 .380 .421 .237 .263 .190 .211 .118 .132 .095 .106
4. kV mA or mAs
1. lg. mA station 250 320 400 500 640 800 1000 1250
2. exp. time (ref.) 0.080 0.064 0.050 0.040 0.032 0.025 0.020 0.016
3. timer limits (ref.) .076 .085 .060 .068 .047 .053 .038 .043 .030 .034 .023 .027 .019 .022 .015 .017
4. kV mA or mAs
1. sm. mA station 10.0 12.5 40.0 50.0 80.0 100 160 200
2. exp. time (ref.) 2.000 1.600 0.500 0.400 0.250 0.200 0.125 0.100
3. timer limits (ref.) 1.90 2.10 1.52 1.68 .475 .526 .380 .421 .237 .263 .190 .211 .118 .132 .095 .106
4. kV mA or mAs
1. lg. mA station 250 320 400 500 640 800 1000 1250
2. exp. time (ref.) 0.080 0.064 0.050 0.040 0.032 0.025 0.020 0.016
3. timer limits (ref.) .076 .085 .060 .068 .047 .053 .038 .043 .030 .034 .023 .027 .019 .022 .015 .017
4. kV mA or mAs
1. sm. mA station 10.0 12.5 40.0 50.0 80.0 100 160 200
2. exp. time (ref.) 2.000 1.600 0.500 0.400 0.250 0.200 0.125 0.100
3. timer limits (ref.) 1.90 2.10 1.52 1.68 .475 .526 .380 .421 .237 .263 .190 .211 .118 .132 .095 .106
4. kV mA or mAs
1. lg. mA station 250 320 400 500 640 800 1000 1250
2. exp. time (ref.) 0.080 0.064 0.050 0.040 0.032 0.025 0.020 0.016
3. timer limits (ref.) .076 .085 .060 .068 .047 .053 .038 .043 .030 .034 .023 .027 .019 .022 .015 .017
4. kV mA or mAs
72 1 Form F3382
TECHNIQUE ACCURACY / INDIRECT EXPOSURE LINEARITY - MULTI-FOCUS TUBE

1. sm. mA station 10.0 12.5 40.0 50.0 80.0 100 160 200
2. exp. time (ref.) 2.000 1.600 0.500 0.400 0.250 0.200 0.125 0.100
3. timer limits (ref.) 1.90 2.10 1.52 1.68 .47 .53 .380 .421 .237 .263 .190 .211 .118 .132 .095 .106
4. kV mA or mAs
1. lg. mA station 250 320 400 500 640 800 1000 1250
2. exp. time (ref.) 0.080 0.064 0.050 0.040 0.032 0.025 0.020 0.016
3. timer limits (ref.) .076 .085 .060 .068 .047 .053 .038 .043 .030 .034 .023 .027 .019 .022 .015 .017
4. kV mA or mAs
Biased focal spot 0.3 mm mA rejection limits +/-25% +/-0.0 mA how do I change rejection limits?
1. mA stations
2. exp. time (ref.)
3. timer limits (ref.)
4. kV mA or mAs
1. sm. mA station 10.0 12.5 40.0 50.0 80.0 100 160 200
2. exp. time (ref.) 2.000 1.600 0.500 0.400 0.250 0.200 0.125 0.100
3. timer limits (ref.) 1.90 2.10 1.52 1.68 .47 .53 .380 .421 .237 .263 .190 .211 .118 .132 .095 .106
4. kV mA or mAs
1. lg. mA station 250 320 400 500 640 800 1000 1250
2. exp. time (ref.) 0.080 0.064 0.050 0.040 0.032 0.025 0.020 0.016
3. timer limits (ref.) .076 .085 .060 .068 .047 .053 .038 .043 .030 .034 .023 .027 .019 .022 .015 .017
4. kV mA or mAs
1. mA stations
2. exp. time (ref.)

4. kV mA or mAs
1. sm. mA station 10.0 12.5 40.0 50.0 80.0 100 160 200
2. exp. time (ref.) 2.000 1.600 0.500 0.400 0.250 0.200 0.125 0.100
3. timer limits (ref.) 1.90 2.10 1.52 1.68 .47 .53 .380 .421 .237 .263 .190 .211 .118 .132 .095 .106
4. kV mA or mAs
1. lg. mA station 250 320 400 500 640 800 1000 1250
2. exp. time (ref.) 0.080 0.064 0.050 0.040 0.032 0.025 0.020 0.016
3. timer limits (ref.) .076 .085 .060 .068 .047 .053 .038 .043 .030 .034 .023 .027 .019 .022 .015 .017
4. kV mA or mAs
1. mA stations
2. exp. time (ref.)
4. kV mA or mAs
Overhead collimator tests can be performed using a graph paper technique, as explained
below or in 46-017564 HHS Collimator Tests. This technique requires only one film and one
exposure for all size to size tests. It’s faster, easier, and at least as accurate as multiple
film techniques.
Instructions
1. Place large, loaded cassette in bucky.

2. Collimate smaller than film size.
3. Attach pattern to window of collimator.
4. Measure the light field using the pattern and scales along edges (doesn’t matter that
long. and lat. scales are different). Add left and right dimensions or top and bottom to
get size (e.g. 19.5 left and 20 right = 39.5 units total).
5. Enter this data into HHS form 3382, (hard copy or laptop form 3382.xls)
6. Expose the film.
7. Measure the actual field size and enter this data onto form. The laptop program will
calculate correlation ratios for any SIDs that you indicate; otherwise calculate these
ratios and enter onto hard copy form.
8. Insert empty small, medium, and large cassettes into the bucky, with the collimator
in auto mode. Enter the light field size onto the form. The laptop program will
calculate corresponding X–Ray field sizes; otherwise calculate the sizes and enter
onto hard copy form.
74 1 Form F3382
Illustration 4-6:

76 1 Form F3382
Chapter 5 Form F3382MM

1 Form F3382MM
Illustration 5-1:
Chapter 5 Form F3382MM 77

Illustration 5-2: Instructions - 46-017565 HHS Mammography Tests, chapter 2 and 3
78 1 Form F3382MM
Illustration 5-3: Instructions - 46-017565 HHS Mammography Tests, chapter 4

80 1 Form F3382MM

82 1 Form F3382MM

Illustration 5-8:
84 1 Form F3382MM
Illustration 5-9:

86 1 Form F3382MM
Chapter 6 Form F3382SS (Hard Copy Only)

1 Form F3382SS (Hard Copy only)
Use this form together with 46-017567 HHS Stenoscop Tests.
Illustration 6-1: Data Record for HHS Field Tests for Stenoscop (Also for Tube Replacement or
Re-load)
Chapter 6 Form F3382SS (Hard Copy Only) 87

Illustration 6-2: Page 2 of 8
88 1 Form F3382SS (Hard Copy only)







Chapter 7 Form F3382MX (Hard Copy Only)

1 Form F3382MX (Hard Copy only)
Chapter 7 Form F3382MX (Hard Copy Only) 95

96 1 Form F3382MX (Hard Copy only)







Chapter 8 Form 3382 for Innova Vascular Products

1 Form 3382 for Innova Vascular Products
Data results for Innova Vascular Products will be captured in the spreadsheet 3382IN. The
last version of the spreadsheed is available on Support Central HHS.
Chapter 8 Form 3382 for Innova Vascular Products 103

104 1 Form 3382 for Innova Vascular Products

78530, Buc
FRANCE
GE Healthcare
HHS
Stenoscop Tests
46-017567
Revision 3
HHS Stenoscop Tests
2
HHS Stenoscop Tests
LANGUAGE
HHS Stenoscop Tests
HHS Stenoscop Tests
HHS Stenoscop Tests
HHS Stenoscop Tests
HHS Stenoscop Tests
HHS Stenoscop Tests
HHS Stenoscop Tests
HHS Stenoscop Tests
HHS Stenoscop Tests
HHS Stenoscop Tests
Revision History
1 Apr. 30, 1996 Format changes only. -
2 Jan. 19, 2005 Updated as per SPR EURge16987 (added mGy units alongwith Roentgen -
units) in pages 3 and 5.
Revision History 13
HHS Stenoscop Tests
14 Revision History
HHS Stenoscop Tests
Table of Contents
1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.1 X-Ray Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3 REG0106 - Generator Operator Indicators . . . . . . . . . . . . . . . . . . . . . . . . 20
4 REG0107 - Generator Timer Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . 21
5 REG0108 - kVp/mA & Generator mAs Specification Accuracy . . . . . . . . . . . . . . . 22
6 Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
7 AEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
8 REG0109 - Reproducibility of Exposure . . . . . . . . . . . . . . . . . . . . . . . . . 25
9 REG0110 - Beam Quality (Half Value Layer) . . . . . . . . . . . . . . . . . . . . . . . 28
10 REG0111 - Fluoro Entrance Exposure Rate . . . . . . . . . . . . . . . . . . . . . . . 29
11 Primary Barrier Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
12 Under Table Tube Leakage Radiation . . . . . . . . . . . . . . . . . . . . . . . . . 32
13 Fluoro Interlocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
14 REG0112 - Fluoro Collimator to Spot-Film Alignment . . . . . . . . . . . . . . . . . . . 34
15 REG0113 - Fluoro Collimator to Image Intensifier . . . . . . . . . . . . . . . . . . . . 36
HHS Stenoscop Tests
HHS Stenoscop Tests
1 Safety


OR DEVICES BE USED.
a physician.
AMERICAS W–622
P.O. BOX 414
1 Safety 17
HHS Stenoscop Tests



18 1 Safety
HHS Stenoscop Tests
2 Introduction
The Stenoscop requires field tests that differ from the other systems described in this
direction. This section includes all field tests required for establishing compliance with
HHS guidelines.
Review all tests in this section and plan an efficient testing program. It is suggested that
the testing be done in an R&F Room where a table top is available to support the radiation
probe and other test equipment.
2 Introduction 19
HHS Stenoscop Tests
3 REG0106 - Generator Operator Indicators


3.2 Overview
Application: at installation, preventative maintenance, and repair.


Audible tones are required for radiographic - -
exposure termination, and for 5 minute
fluoroscopic exposure termination.
X–Ray warning label shall be present. - -
3.4 Procedure
1. Check for proper operation of audible tones and buzzers at termination of radiographic
and fluoroscopic exposures.
2. Verify the presence of a warning label. This can be found below the lock for rotational
motion of the “C” arm.
3. Record data on Form F3382SS.
3.5 Finalization
20 3 REG0106 - Generator Operator Indicators

HHS Stenoscop Tests
4 REG0107 - Generator Timer Accuracy


4.2 Overview
Application: At installation, preventative maintenance, and repair.


Only the fluoroscopic timer accuracy is - -
applicable.
4.4 Procedure
1. Verify fluoro timer accuracy.
2. Record data on Form F3382SS.
4.5 Finalization
4 REG0107 - Generator Timer Accuracy 21

HHS Stenoscop Tests
5 REG0108 - kVp/mA & Generator mAs Specification Accuracy


5.2 Overview
There is no linearity requirement, as linearity does not apply to equipment which does
not offer a choice of mA stations.
NOTE: For the Stenoscop, the tests are performed simultaneously. See the Data Record Chart
of Form F3382SS.
Application: At installation, preventative maintenance, and repair.


kVp and mAs (or mA and time) shall match - -
selected kVp and mAs (or mA and time)
within the specified accuracy.
5.4 Procedure
NOTE: The Keithley will be used to measure kVp. However, in order to make this a valid test, it will
be necessary to verify half value layer first.
1. Make exposures at 50, 80, and 110 kVp and 100 mAs.
2. Use the Keithley to check kVp.
3. Use an external mAs meter to check mAs. If an external mAs meter is not available, then
use the Keithley to check time, and connect an external mA meter.
4. Record the results on Form F3382SS.
5.5 Finalization
22 5 REG0108 - kVp/mA & Generator mAs Specification Accuracy

HHS Stenoscop Tests
6 Linearity
Linearity is not applicable on systems that don’t offer a choice of mA stations.
6 Linearity 23
HHS Stenoscop Tests
7 AEC
AEC is not applicable.
24 7 AEC
HHS Stenoscop Tests
8 REG0109 - Reproducibility of Exposure


8.2 Overview
Application: at installation, preventive maintenance, and repair.
NOTE: This test does not apply to systems that don’t have a SFD (cassette holder on the face
of the intensifier).


integrate mode

For any specific combination of selected 21CRF-J-1020.31 (b1) -
technique factors, the estimated coefficient
of variation, C.V., of radiation exposures
shall be no greater than 0.05. Rejection
limit 0.045. This requirement holds for
exposures made with and without use
of A.E.C. This does not apply to image
intensified applications, cine, photospot
or digital.
8.4 Procedure
1. Arrange the equipment per Illustration below; the standard absorber is not used. Avoid
probe saturation (see 46–017560, HHS TOOLS).

HHS Stenoscop Tests
Illustration 1: Half Value Layer Test
2. Select 80 kVp and 0.1 second.
3. Collimate to a field approximately 5 inches across, (13 cm square).
4. Measure the mGy (mR) for each of 10 exposures. After each exposure, recycle the rotor
and the technic switches; that is, set the switches to other values and then return them
to the original values.
5. Examine the data. If the highest and lowest readings are within 10% of each other, it is
not necessary to perform the Coefficient of Variation calculations. If the high and low
readings don’t fit the above criteria, then it will be necessary to calculate the coefficient of
variation (C.V.).
C.V. = s / X (avg.) where s = sample standard deviation (n-1)
26 8 REG0109 - Reproducibility of Exposure

HHS Stenoscop Tests
NOTE: Sample standard deviation can be calculated on a calculator with statistics functions (such as
the TI 36X provided with the HHS kit) as follows:
1. Clear the stat register, press (CSR).

2. Enter the first reading and then press (∑+), likewise for all readings.
3. Press (mean) to get X average.
4. Press sample standard deviation key (n–1).
5. Enter the results in the formula above.
8.5 Finalization

HHS Stenoscop Tests
9 REG0110 - Beam Quality (Half Value Layer)


9.2 Procedure
1. Use 46–017562, HHS BEAM QUALITY TEST for this test.
2. Use Illustration below for equipment set up.
Illustration 2: Half Value Layer Test
3. Record results on Form F3382SS.
9.3 Finalization
28 9 REG0110 - Beam Quality (Half Value Layer)

HHS Stenoscop Tests
10 REG0111 - Fluoro Entrance Exposure Rate


10.2 Procedure
1. Use 46–017563, HHS FLUORO SYSTEM TESTS for this test.
2. Use Illustration below for equipment set up, but omit the standard absorber.
Illustration 3:
10 REG0111 - Fluoro Entrance Exposure Rate 29

HHS Stenoscop Tests
NOTE: if a [> 5 R] button is provided, then the output is unlimited whenever the button is engaged,
but is limited to only 43.8 mGy/min (5 R/min) whenever the button is not engaged. The
button must disengage when released and there must be a tone the whole time the button
is depressed.
If the [> 5 R] button is functional in only one mode (manual or automatic), then the 5 R limit is
only applicable in that mode. In the mode (manual or automatic in which the button is not
functional, the exposure rate shall be limited to 87.6 mGy/min (10 R/min ).
If there is no [> 5 R] button, the output is limited to 87.6 mGy/min (10 R/min) in any mode.
10.3 Finalization
30 10 REG0111 - Fluoro Entrance Exposure Rate

HHS Stenoscop Tests
11 Primary Barrier Transmission

This test is performed in the factory and is not required in the field.
11 Primary Barrier Transmission 31

HHS Stenoscop Tests
12 Under Table Tube Leakage Radiation

Under table tube leakage radiation is not applicable.
32 12 Under Table Tube Leakage Radiation

HHS Stenoscop Tests
13 Fluoro Interlocks
Fluoro Interlocks is not applicable.
13 Fluoro Interlocks 33
HHS Stenoscop Tests
14 REG0112 - Fluoro Collimator to Spot-Film Alignment


14.2 Overview


The centers of the X–Ray field and the - -
image receptor (film) must match to within
2% (1.8% rejection limit) of the SID.
For either the length or width, the edge to - -
edge misalignment of the X–Ray field and
image receptor (film) may not exceed 3%
(2.8% rejection limit) of the SID. The sum
of length and width misalignments may
not exceed 4% (3.8% rejection limit) of the
SID.
14.4 Procedure
1. Collimate to a rectangular field and expose a film.
2. Draw diagonals on the exposed film to determine the two centers as shown in Illustration
below.
Illustration 4: Center-to-Center Test
3. Measure the distance between the two centers.
34 14 REG0112 - Fluoro Collimator to Spot-Film Alignment

HHS Stenoscop Tests
4. Divide the measurement of Step 3 by the SID and enter the result into the Data Record
Form 3382SS.
NOTE: Since the edges of the spot film exposure are always visible on the film, the field size is
measured directly without resorting to calculations involving magnification. Proceed as
follows:
5. Insert a loaded 9.5” x 9.5” cassette into the holder, open the collimator blades wide,
and make a spot-film exposure.
6. Refer to Illustration below. The lateral and longitudinal dimensions of the field do not
correspond to lateral and longitudinal as defined by the center to center film, but this is
not a problem. We can reasonably assume that the field is indeed round, and that the
discrepancy noted in Illustration below results from the difficulty of measuring a fuzzy
image. Average the readings, and let both the lateral and longitudinal dimensions equal
the average.
Illustration 5: Edge-to-Edge (calculation) Test
7. The lateral and longitudinal dimension of the image must match the dimension of the film
(9.5” x 9.5”) to within 2.8% of the SID. The sum of lateral and longitudinal size errors must
not exceed 3.8% SID. That’s all there is, you’re done!
14.5 Finalization
14 REG0112 - Fluoro Collimator to Spot-Film Alignment 35

HHS Stenoscop Tests
15 REG0113 - Fluoro Collimator to Image Intensifier


15.2 Overview


The edges of the visible area on the - -
monitor must correspond to the edges
of the X–Ray field to within 3% on either
length or width, and 4% on their sum.
The minimum collimator opening must be - -
less than 5 cm square.
15.4 Procedure
1. See example in Illustration below.
36 15 REG0113 - Fluoro Collimator to Image Intensifier

HHS Stenoscop Tests
Illustration 6: Example of Alignment Calculations, Fluoro to Image Intensifier Version
2. Place the light to X-Ray field test pattern on a table and center it in the field.
3. Close the collimator blades and verify that the minimum opening is less than 5 cm square.
4. Open the collimator to maximum and make a note of the pattern increments that are
visible on the monitor in each direction.
5. Place a loaded cassette on top of the pattern and make a short fluoro exposure. Now
measure the distance between the focal spot and the film, this is the source to film
distance.
6. Develop the film and on it, mark the pattern data that you noted in Step 3 . See illustration
below.
15 REG0113 - Fluoro Collimator to Image Intensifier 37

HHS Stenoscop Tests
Illustration 7: X-Ray Field to Image Intensifier Alignment
7. Measure the distance between the mark and the edge of the field in each quadrant.
Divide this value into the source to film distance, convert it into a percentage, and
record it as % of SID.
NOTE: The use of the measured misalignment and the source to film distance gives the same
percentage error regardless of the source to film distance, therefore it is valid to refer to this
as % of SID.
For either the lateral or longitudinal directions, the misalignment must be less than 2.8%
of the SID, and the total misalignment must be less than 3.8% of the SID.
8. Record results on Form F3382SS. See example in Illustration 6 .
15.5 Finalization
38 15 REG0113 - Fluoro Collimator to Image Intensifier

78530, Buc
FRANCE
GE Healthcare
HHS
Kits - Renewal Parts
46-017568
Revision 3
HHS Kits - Renewal Parts
2
LANGUAGE
Revision History
1 Apr. 30, 1996 Format changes only. -
2 Nov. 22, 2000 Introduction of INNOVA 2000 changes. -
3 Dec. 20, 2007 Converted from Interleaf into e-CLS Platform 26
Revision History 13
14 Revision History
Table of Contents
1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.1 X-Ray Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2 HHS Kits - Renewal Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
1 Safety


OR DEVICES BE USED.
a physician.
AMERICAS W–622
P.O. BOX 414
1 Safety 17



18 1 Safety
2 HHS Kits - Renewal Parts

HHS Field Test Kit (46-303879G1)
* Case only (46-216784P7)
NOTE: Upgrade Kit 46-315694G1
Illustration 1:
NOTE: This is a simpler and less expensive version of 46-303879G2. When parts from the
obsolete kit 46-177372 are added to the upgrade kit, the resulting kit is roughly similar to
kit 46-303879G1. Items included in the upgrade kit are marked with an asterisk (*) on
the following pages.
2 HHS Kits - Renewal Parts 19

Illustration 2:
Item NO. Name Part NO. Description
1* Test Grid 46-303867P1 Plexiglas SID Plate, 1 used

2 Test Grid 46-303867P2 Same as item 1 except for XACT collimator, 1 used
3* Test Grid 46-315142P1 PRESTILIX size and alignment plate, 1 used

4 Card Board Cassette 46-194427P345 KODAK 5” x 7” with lead backing, 1 used
5 Vinyl Cassette E0252F A Q Exposure holder, 10” x 12”, no lead, 1 used
6 Vinyl Cassette E0252AD A Q Exposure holder, 10” x 12”, lead backing, 2 used
7* Decimal Scale 46-198452P2 18” decimal english scale, stainless steel, 1 used
8 Calculator 46-194427P329 TI calculator, Solar, Model Tl36X, 1 used
9* Ruler 46-194427P328 LUFKIN Snap Ruler, 36”, 1/8” divisions, 2 used
10* Test Pattern 46-303843P1 Light-to-X-Ray Field Test Pattern, 1 used
NOTE: *These items are also part of upgrade kit, 46-315694G2.
20 2 HHS Kits - Renewal Parts

Illustration 3: Test pattern (item 10)

11 Standard Test Absorber 46-173632G1 2.5 mm type 1100 Aluminium, 1 used
12 HVL Attenuator 46-194427P274 Set of 11 Filters, 1 set used
Illustration 4: Standard Test Absorber (item 11)


13 Attenuation Block 46-177394P2 Type 1100 Aluminium, 2 used
14 Attenuation Block Support 46-177396P1 4 used
15 Air Scatter Shield 46-315507P1 1 used
16 Screw 46-208561P15 Hex HD.CAP 1/4-20 x 1.750 long, 4 used
Air Scatter Shield 46-177395P1 10” x 12”, 1 used (not shown)
Illustration 5: Attenuation Block Assembly and Air Scatter Shield

17 Collimator Port Block (for 46-177717P2 1 used
LFOV)
18* Foam Pad 46-172675P6 .5” thick, 2 used

19* Foam Pad 46-172675P7 .75” thick, 1 used
20* Foam Filler 46-303835P1 1.75” thick, 1 used
NOTE: *These items are also part of upgrade kit, 46-315694G2.
Illustration 6: Collimator Port Block for LFOV (item 17)


21 Tool Case 2280859 Empty, not shown
22 Film Support 2280335
23 Lead Sheet 2280720 Scatter Shield
Illustration 7:


78530, Buc
FRANCE
GE Healthcare
HHS
Field Signature Tests
2257181-100
Revision 1
HHS Field Signature Tests
2
LANGUAGE
Revision History
0 Oct. 8, 1999 Initial release. -
1 Dec. 20, 2007 Converted from Interleaf into e-CLS Platform. 26
Revision History 13
14 Revision History
Table of Contents
1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.1 X-Ray Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3 REG0095 - Technique Accuracy and Indirect Linearity Test . . . . . . . . . . . . . . . . . 20
4 REG0096 - Fluoro Collimator to Spot-film Device . . . . . . . . . . . . . . . . . . . . . 21
5 Fluoro Collimator to Intensifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
6 REG0097 - Size to size testing for Buckys . . . . . . . . . . . . . . . . . . . . . . . . 24
1 Safety


OR DEVICES BE USED.
a physician.
AMERICAS W–622
P.O. BOX 414
1 Safety 17



18 1 Safety
2 Introduction
This following HHS Field Signature Tests apply to Advantx R&F Legacy Systems only.
2 Introduction 19
3 REG0095 - Technique Accuracy and Indirect Linearity Test


3.2 Procedure
NOTE: Ensure the tubes are warmed–up prior to performing this test.
1. Perform this test for the RAD tube and the SF tube in R013.
Use Keithley non–invasive kV meter and software version of 3382 form. Proceed to
the technique accuracy section of the file.
2. Take a minimum of 6 exposures, one for each filament at 60, 80, and 130 kVp.
The suggested mA for these tests is XS = 100 mA and XL = 500 mA at 20 mAs. Another
way to determine test points is to examine the Factory data; choose those mA stations
that show the worst accuracy and record new data over–writing the Factory data. If the
“Pass” flag remains intact, you are finished with the Technique Accuracy and Indirect
Linearity Test.
3. If any flags go up:
a. Perform meter calibrations: R024, R025 and R021. Then repeat Step 1 and Step 2 .
b. If an mA or kV flag goes up, recalibrate the mA stations or kV associated with that

entire row in R013.
c. If a linearity flag goes up but not an mA or kV flag on the same row, you may attempt
to recalibrate just in the area of the linearity flag.
20 3 REG0095 - Technique Accuracy and Indirect Linearity Test

4 REG0096 - Fluoro Collimator to Spot-film Device


4.2 Procedure
1. Center to Center Test – Examine the Factory data for Fluoro Collimator to SFD Centering
and note the two worst cases. You must repeat the centering test for these two cases.
2. Adjust the equipment per the format and angulation indicated by the exposures selected
in Step 1 . Place 0.25” aluminum or 0.03” copper on the table.
3. Insert a loaded cassette and collimate below format size. Select 80 kV and expose
the film.
4. Draw a rectangle around the image and then find the center by drawing diagonals.
Find the center of the film format area by dividing the film into equal parts and drawing
diagonals across the format area.
5. Measure the displacement of the two centers and enter the data onto the form
over–writing the Factory data. Repeat this process for each exposure. Provided no
measurements cause a “Fail” flag to come up, you are finished with this test.
6. Size to Size Test – You must begin this test by starting at the very top of the form for
SFD’s. Click on the index tab, and then click on the Fluoro Collimator to SFD test to
ensure that you see the top of the form. The Factory will have entered a single number for
the total thickness of material between the hard surface of the table top and the bottom of
the test tool (which could be a vinyl cassette, or perhaps in your case, the phosphor tool).
Regardless of which tool you use for this test, you must ensure that the total thickness of
material corresponds to the thickness intended by the Factory.
7. Examine the Factory data and note the two worst cases.
8. Adjust the equipment per the format and angulation indicated by these worst cases.
9. If using the phosphor tool, remove the plate and reinsert it in the holder face down.
Center the tool (approximately) under fluoro; open end should be towards the head of the
table. Cover the tool with lead and expose at 100 kV, 200 to 400 mAs.
If using film, place the vinyl cassette on the table, center it, cover it with 0.25” aluminum or
0.03” copper, and expose at 60 to 80 kV using AEC mode.
10. If using the phosphor tool, examine the image in very dim light. Using a soft pencil,
quickly mark the edges of the field on the phosphor (the covering is erasable). Turn on the
lights and read the image size. Add N–S (for longitudinal) and E–W (for lateral) readings
and enter dimensions onto the form over–writing the Factory data. Once exposed to room
light the phosphor will continue to glow for 1–3 minutes. Allow adequate time between
exposures for the phosphorescence to subside.
4 REG0096 - Fluoro Collimator to Spot-film Device 21

If using film, measure the image using a view box. If necessary, adjust technique to obtain
optical density of 1.3 +/– 0.2; this is a critical step in order to have a valid comparison
of Field and Factory measurements. Enter dimensions onto the form over–writing the
Factory data.
11. Repeat the phosphor tool or film tests for each setup identified in Step 7 . Provided no
“Fail” flags appear, you are finished with this portion of the Signature Tests.
22 4 REG0096 - Fluoro Collimator to Spot-film Device

5 Fluoro Collimator to Intensifier

With the table horizontal and at minimum SID, verify all four collimator blades are visible in
each magnification mode. Do not test with table angulated or at other SID.
• If the system passes this test, no entries will be made in the Fluoro Collimator to
Intensifier data record, and you will be finished with this test.
• If the systems fails this test, then check “no” for any mag mode where it failed and
complete the lower section of the data record.
• If the system passes on the lower section of the data record, no further testing is
required (do not angulate table or change SID).
• If the systems fails on the lower section of the data record, you will need to rework the
collimator to intensifier sizing and retest; again, the retesting should be done only with
the table horizontal at minimum SID.
5 Fluoro Collimator to Intensifier 23

6 REG0097 - Size to size testing for Buckys


6.2 Procedure
1. Begin this test by selecting Auto Collimator to the appropriate bucky. The ratio test
has already been performed. Verify the system still passes HHS by performing the
following test.
2. Select the smallest SID, examine the Factory data and note the cassette size that had
the worst size errors.
3. Set up the equipment as per the format indicated by the worst case.
4. Measure the corresponding light field size at the collimator.
5. Enter data onto the HHS form in the column labeled “Light Field” overwriting the Factory
data.
6. Provided no “Fail” flags appear, you are finished with this portion of the signature tests.
24 6 REG0097 - Size to size testing for Buckys

78530, Buc
FRANCE

System Field Test For HHS: 46-013894 Revision 66 US English © 2021 General Electric Company All Rights Reserved

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

System Field Test For HHS: 46-013894 Revision 66 US English © 2021 General Electric Company All Rights Reserved

Uploaded by

Copyright:

Available Formats

HHS

System Field Test for HHS

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

46-013894 Revision 66 HHS 3/18

UPOZORENJE Ovaj servisni priručnik dostupan je na engleskom jeziku.

4/18 HHS 46-013894 Revision 66

ATTENTION Ce manuel d'installation et de maintenance est disponible uniquement en anglais.

46-013894 Revision 66 HHS 5/18

경고 본 서비스 매뉴얼은 영어로만 이용하실 수 있습니다.

6/18 HHS 46-013894 Revision 66

ATENŢIE Acest manual de service este disponibil doar în limba engleză.

46-013894 Revision 66 HHS 7/18

DİKKAT Bu servis kılavuzunun sadece ingilizcesi mevcuttur.

8/18 HHS 46-013894 Revision 66

Rev Date Reason for change

46-013894 Revision 66 HHS 9/18

Rev Date Reason for change

10/18 HHS 46-013894 Revision 66

Rev Date Reason for change

46-013894 Revision 66 HHS 11/18

46-013894 Revision 66 HHS 13/18

1.1 Collector Table of Contents

46-013894 Revision 66 HHS 15/18

This page left intentionally blank.

1 Apr. 30, 1996 General revisions. -

3 Dec. 20, 2007 Converted from Interleaf into e-CLS platform 48

This page left intentionally blank.

CHAPTER 2 OPERATING PLAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

CHAPTER 3 TEST REQUIREMENT TABLES . . . . . . . . . . . . . . . . . . . . . . . 27

CHAPTER 4 FIELD FDA COMPLIANCE PLAN . . . . . . . . . . . . . . . . . . . . . . 31

This page left intentionally blank.

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

IT IS IMPORTANT THAT EVERYONE HAVING ANYTHING TO DO WITH

GENERAL ELECTRIC COMPANY MEDICAL SYSTEMS

MANAGER – INFORMATION INTEGRATION,

P.O. BOX 414

1.2 Certified Electrical Contractor Statement

1.3 Damage in Transportation

Call Traffic and Transportation, Milwaukee, WI (414) 827–3449 / 8*285–3449 immediately

Chapter 2 Operating Plan

• Emphasize the importance of HHS compliance procedures.

A certification plate includes a statement such as:

1.3 How To Use

Chapter 2 Operating Plan 19

Illustration 2-1: Summary of HHS Field Testing

• Install equipment – Install equipment according to installation instructions provided

NOTE: DO NOT REPORT:

1. X-Ray tube replacements of any type;

Chapter 2 Operating Plan 21

Beam Limiting Device – Collimator or cone to define X–Ray field.

Cone – Fixed aperture beam limiting device.

where s = standard deviation of sample

= mean value of exposures in sample

Xi = ith observed value of exposure

n = number of observations, (10)

Manufacturer – Manufacturers and assembles equipment at factory site. For diagnostic

Chapter 2 Operating Plan 23

3 Mixing certified with non-certified Equipments

24 3 Mixing certified with non-certified Equipments

4 FDA Requirements unique to Therapy Simulators

Chapter 2 Operating Plan 25

This page left intentionally blank.

26 4 FDA Requirements unique to Therapy Simulators