HHS System Field Test For HHS: 46-013894 Revision 62

HHS
System Field Test for HHS
OPERATING DOCUMENTATION
46-013894
Revision 62
HHS System Field Test for HHS
Direction 46-013894, Revision 62
2
Important Information
LANGUAGE
ПРЕДУПРЕЖДЕНИЕ Това упътване за работа е налично само на английски език.
(BG) • Ако доставчикът на услугата на клиента изиска друг език, задължение на
клиента е да осигури превод.
• Не използвайте оборудването, преди да сте се консултирали и разбрали

упътването за работа.
• Неспазването на това предупреждение може да доведе до нараняване на

доставчика на услугата, оператора или пациентa в резултат на токов удар,
механична или друга опасност.
警告本维修手册仅提供英文版本。
(ZH-CN) • 如果客户的维修服务人员需要非英文版本，则客户需自行提供翻译服务。
• 未详细阅读和完全理解本维修手册之前，不得进行维修。
• 忽略本警告可能对维修服务人员、操作人员或患者造成电击、机械伤害或其他形式的
伤害。
警告本服務手冊僅提供英文版本。
(ZH-HK) • 倘若客戶的服務供應商需要英文以外之服務手冊，客戶有責任提供翻譯服務。
• 除非已參閱本服務手冊及明白其內容，否則切勿嘗試維修設備。
• 不遵從本警告或會令服務供應商、網絡供應商或病人受到觸電、機械性或其他的危
險。
警告本維修手冊僅有英文版。
(ZH-TW) • 若客戶的維修廠商需要英文版以外的語言，應由客戶自行提供翻譯服務。
• 請勿試圖維修本設備，除非您已查閱並瞭解本維修手冊。
• 若未留意本警告，可能導致維修廠商、操作員或病患因觸電、機械或其他危險而受
傷。
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.
Important Information 3
VÝSTRAHA Tento provozní návod existuje pouze v anglickém jazyce.

(CS) • V případě, že externí služba zákazníkům potřebuje návod v jiném jazyce, je zajiště‐
ní překladu do odpovídajícího jazyka úkolem zákazníka.
• Nesnažte se o údržbu tohoto zařízení, aniž byste si přečetli tento provozní návod a
pochopili jeho obsah.
• V případě nedodržování této výstrahy může dojít k poranění pracovníka prodejního

servisu, obslužného personálu nebo pacientů vlivem elektrického proudu, respektive
vlivem mechanických či jiných rizik.
ADVARSEL Denne servicemanual findes kun på engelsk.

(DA) • Hvis en kundes tekniker har brug for et andet sprog end engelsk, er det kundens
ansvar at sørge for oversættelse.
• Forsøg ikke at servicere udstyret uden at læse og forstå denne servicemanual.
• Manglende overholdelse af denne advarsel kan medføre skade på grund af elektrisk

stød, mekanisk eller anden fare for teknikeren, operatøren eller patienten.
WAARSCHUWING Deze onderhoudshandleiding is enkel in het Engels verkrijgbaar.

(NL) • Als het onderhoudspersoneel een andere taal vereist, dan is de klant verantwoorde‐
lijk voor de vertaling ervan.
• Probeer de apparatuur niet te onderhouden alvorens deze onderhoudshandleiding

werd geraadpleegd en begrepen is.
• Indien deze waarschuwing niet wordt opgevolgd, zou het onderhoudspersoneel, de

operator of een patiënt gewond kunnen raken als gevolg van een elektrische schok,
mechanische of andere gevaren.
WARNING This service manual is available in English only.

(EN) • If a customer's service provider requires a language other than English, it is the cus‐
tomer's responsibility to provide translation services.
• Do not attempt to service the equipment unless this service manual has been con‐
sulted 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, vastu‐
tab 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 pat‐

siendi vigastamist elektrilöögi, mehaanilise või muu ohu tagajärjel.
4 Important Information
VAROITUS Tämä huolto-ohje on saatavilla vain englanniksi.

(FI) • Jos asiakkaan huoltohenkilöstö vaatii muuta kuin englanninkielistä materiaalia, tar‐
vittavan 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, laitteis‐

ton käyttäjän tai potilaan vahingoittuminen sähköiskun, mekaanisen vian tai muun
vaaratilanteen vuoksi.
ATTENTION Ce manuel d’installation et de maintenance est disponible uniquement en anglais.

(FR) • Si le technicien d'un client a besoin de ce manuel dans une langue autre que l'an‐
glais, il incombe au client de le faire traduire.
• Ne pas tenter d'intervenir sur les équipements tant que ce manuel d’installation et
de maintenance n'a pas été consulté et compris.
• Le non-respect de cet avertissement peut entraîner chez le technicien, l'opérateur

ou le patient des blessures dues à des dangers électriques, mécaniques ou autres.
WARNUNG Diese Serviceanleitung existiert nur in englischer Sprache.

(DE) • Falls ein fremder Kundendienst eine andere Sprache benötigt, ist es Aufgabe des
Kunden für eine entsprechende Übersetzung zu sorgen.
• Versuchen Sie nicht diese Anlage zu warten, ohne diese Serviceanleitung gelesen
und verstanden zu haben.
• Wird diese Warnung nicht beachtet, so kann es zu Verletzungen des Kundendienst‐

technikers, des Bedieners oder des Patienten durch Stromschläge, mechanische
oder sonstige Gefahren kommen.
ΠΡΟΕΙΔΟΠΟΙΗΣΗ Το παρόν εγχειρίδιο σέρβις διατίθεται μόνο στα αγγλικά.

(EL) • Εάν ο τεχνικός σέρβις ενός πελάτη απαιτεί το παρόν εγχειρίδιο σε γλώσσα εκτός των
αγγλικών, αποτελεί ευθύνη του πελάτη να παρέχει τις υπηρεσίες μετάφρασης.
• Μην επιχειρήσετε την εκτέλεση εργασιών σέρβις στον εξοπλισμό αν δεν έχετε
συμβουλευτεί και κατανοήσει το παρόν εγχειρίδιο σέρβις.
• Αν δεν προσέξετε την προειδοποίηση αυτή, ενδέχεται να προκληθεί τραυματισμός

στον τεχνικό σέρβις, στο χειριστή ή στον ασθενή από ηλεκτροπληξία, μηχανικούς ή
άλλους κινδύνους.
FIGYELMEZTETÉS Ezen karbantartási kézikönyv kizárólag angol nyelven érhető el.

(HU) • Ha a vevő szolgáltatója angoltól eltérő nyelvre tart igényt, akkor a vevő felelőssége
a fordítás elkészíttetése.
• Ne próbálja elkezdeni használni a berendezést, amíg a karbantartási kézikönyvben

leírtakat nem értelmezték.
• Ezen figyelmeztetés figyelmen kívül hagyása a szolgáltató, működtető vagy a beteg

áramütés, mechanikai vagy egyéb veszélyhelyzet miatti sérülését eredményezheti.
AÐVÖRUN Þessi þjónustuhandbók er aðeins fáanleg á ensku.

(IS) • Ef að þjónustuveitandi viðskiptamanns þarfnast annas tungumáls en ensku, er það
skylda viðskiptamanns að skaffa tungumálaþjónustu.
• Reynið ekki að afgreiða tækið nema að þessi þjónustuhandbók hefur verið skoðuð
og skilin.
• Brot á sinna þessari aðvörun getur leitt til meiðsla á þjónustuveitanda, stjórnanda
eða sjúklings frá raflosti, vélrænu eða öðrum áhættum.
AVVERTENZA Il presente manuale di manutenzione è disponibile soltanto in lingua inglese.

(IT) • Se un addetto alla manutenzione richiede il manuale in una lingua diversa, il cliente
è tenuto a provvedere direttamente alla traduzione.
• Procedere alla manutenzione dell'apparecchiatura solo dopo aver consultato il pre‐

sente manuale ed averne compreso il contenuto.
• Il mancato rispetto della presente avvertenza potrebbe causare lesioni all'addetto al‐
la manutenzione, all'operatore o ai pazienti provocate da scosse elettriche, urti mec‐
canici o altri rischi.
警告このサービスマニュアルには英語版しかありません。
(JA) • サービスを担当される業者が英語以外の言語を要求される場合、翻訳作業はその業
者の責任で行うものとさせていただきます。
• このサービスマニュアルを熟読し理解せずに、装置のサービスを行わないでくださ
い。
• この警告に従わない場合、サービスを担当される方、操作員あるいは患者さんが、
感電や機械的又はその他の危険により負傷する可能性があります。
경고 본 서비스 매뉴얼은 영어로만 이용하실 수 있습니다.

(KO) • 고객의 서비스 제공자가 영어 이외의 언어를 요구할 경우, 번역 서비스를 제공하는
것은 고객의 책임입니다.
• 본 서비스 매뉴얼을 참조하여 숙지하지 않은 이상 해당 장비를 수리하려고 시도하지

마십시오.
• 본 경고 사항에 유의하지 않으면 전기 쇼크, 기계적 위험, 또는 기타 위험으로 인해 서

비스 제공자, 사용자 또는 환자에게 부상을 입힐 수 있습니다.
BRĪDINĀJUMS Šī apkopes rokasgrāmata ir pieejama tikai angļu valodā.

(LV) • Ja klienta apkopes sniedzējam nepieciešama informācija citā valodā, klienta pienā‐
kums ir nodrošināt tulkojumu.
• Neveiciet aprīkojuma apkopi bez apkopes rokasgrāmatas izlasīšanas un sapraša‐

nas.
• Šī brīdinājuma neievērošanas rezultātā var rasties elektriskās strāvas trieciena, me‐

hānisku 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

eksploatavimo vadovo.
• Jei nepaisysite šio įspėjimo, galimi paslaugų tiekėjo, operatoriaus ar paciento suža‐
lojimai 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, oper‐
atøren 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 tłu‐
maczenia jest obowiązkiem klienta.
• Nie próbować serwisować urządzenia bez zapoznania się z niniejszym podręczni‐

kiem serwisowym i zrozumienia go.
• Niezastosowanie się do tego ostrzeżenia może doprowadzić do obrażeń serwisan‐

ta, operatora lub pacjenta w wyniku porażenia prądem elektrycznym, zagrożenia
mechanicznego bądź innego.
ATENÇÃO Este manual de assistência técnica encontra-se disponível unicamente em inglês.

(PT-BR) • Se outro serviço de assistência técnica solicitar a tradução deste manual, caberá ao
cliente fornecer os serviços de tradução.
• Não tente reparar o equipamento sem ter consultado e compreendido este manual
de assistência técnica.
• A não observância deste aviso pode ocasionar ferimentos no técnico, operador ou

paciente decorrentes de choques elétricos, mecânicos ou outros.
ATENÇÃO Este manual de assistência técnica só se encontra disponível em inglês.

(PT-PT) • Se qualquer outro serviço de assistência técnica solicitar este manual noutro idio‐
ma, é da responsabilidade do cliente fornecer os serviços de tradução.
• O não cumprimento deste aviso pode colocar em perigo a segurança do técnico, do

operador ou do paciente devido a choques eléctricos, mecânicos ou outros.
ATENŢIE Acest manual de service este disponibil doar în limba engleză.

(RO) • Dacă un furnizor de servicii pentru clienţi necesită o altă limbă decât cea engleză,
este de datoria clientului să furnizeze o traducere.
• Nu încercaţi să reparaţi echipamentul decât ulterior consultării şi înţelegerii acestui

manual de service.
• Ignorarea acestui avertisment ar putea duce la rănirea depanatorului, operatorului

sau pacientului în urma pericolelor de electrocutare, mecanice sau de altă natură.
ОСТОРОЖНО! Данное руководство по техническому обслуживанию представлено только на

(RU) английском языке.
• Если сервисному персоналу клиента необходимо руководство не на
английском, а на каком-то другом языке, клиенту следует самостоятельно
обеспечить перевод.
• Перед техническим обслуживанием оборудования обязательно обратитесь к

данному руководству и поймите изложенные в нем сведения.
• Несоблюдение требований данного предупреждения может привести к тому,

что специалист по техобслуживанию, оператор или пациент получит удар
электрическим током, механическую травму или другое повреждение.
UPOZORENJE Ovo servisno uputstvo je dostupno samo na engleskom jeziku.

(SR) • Ako klijentov serviser zahteva neki drugi jezik, klijent je dužan da obezbedi prevodi‐
lačke usluge.
• Ne pokušavajte da opravite uređaj ako niste pročitali i razumeli ovo servisno uputst‐
vo.
• Zanemarivanje ovog upozorenja može dovesti do povređivanja servisera, rukovaoca

ili pacijenta usled strujnog udara ili mehaničkih i drugih opasnosti.
UPOZORNENIE Tento návod na obsluhu je k dispozícii len v angličtine.

(SK) • Ak zákazníkov poskytovateľ služieb vyžaduje iný jazyk ako angličtinu, poskytnutie
prekladateľských služieb je zodpovednosťou zákazníka.
• Nepokúšajte sa o obsluhu zariadenia, kým si neprečítate návod na obluhu a nepor‐

ozumiete mu.
• Zanedbanie tohto upozornenia môže spôsobiť zranenie poskytovateľa služieb, ob‐

sluhujúcej osoby alebo pacienta elektrickým prúdom, mechanické alebo iné ohroze‐
nie.
ATENCION Este manual de servicio sólo existe en inglés.

(ES) • Si el encargado de mantenimiento de un cliente necesita un idioma que no sea el
inglés, el cliente deberá encargarse de la traducción del manual.
• No se deberá dar servicio técnico al equipo, sin haber consultado y comprendido

este manual de servicio.
• La no observancia del presente aviso puede dar lugar a que el proveedor de servi‐
cios, el operador o el paciente sufran lesiones provocadas por causas eléctricas,
mecánicas o de otra naturaleza.
VARNING Den här servicehandboken finns bara tillgänglig på engelska.

(SV) • Om en kunds servicetekniker har behov av ett annat språk än engelska, ansvarar
kunden för att tillhandahålla översättningstjänster.
• Försök inte utföra service på utrustningen om du inte har läst och förstår den här
servicehandboken.
• Om du inte tar hänsyn till den här varningen kan det resultera i skador på servicete‐
knikern, 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 za‐
gotoviti prevod.
• Ne poskušajte servisirati opreme, če tega priročnika niste v celoti prebrali in razu‐

meli.
• Če tega opozorila ne upoštevate, se lahko zaradi električnega udara, mehanskih ali

drugih nevarnosti poškoduje ponudnik storitev, operater ali bolnik.
DİKKAT Bu servis kılavuzunun sadece ingilizcesi mevcuttur.

(TR) • Eğer müşteri teknisyeni bu kılavuzu ingilizce dışında bir başka lisandan talep
ederse, bunu tercüme ettirmek müşteriye düşer.
• Servis kılavuzunu okuyup anlamadan ekipmanlara müdahale etmeyiniz.
• Bu uyarıya uyulmaması, elektrik, mekanik veya diğer tehlikelerden dolayı teknisyen,

operatör veya hastanın yaralanmasına yol açabilir.
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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 compli‐
ance engineers.
10 Aug. 22, 1986 Revised Tests 5-1 and 5-2 geometry for C-Arm. Revised Test 5–3 for uncerti‐
fied 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. Added
Forms F3382MX, F3382MM and F3382SS to Section 8. General revisions.
Preliminary not released for publication, archived microfiche 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 gener‐
ator.
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, following INNO‐
VA 2000 introduction.
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 In‐
nova 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 Lib‐
erty Bolus milestone M3 (SPR EURge16987) 46–017561 (SPR EURge20430)
Revision History 11
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 Inno‐
va 4100-IQ information.
• 46–017562 by adding new values for Beam Quality test (EURge39873)

and Innova 3100-IQ and Innova 4100-IQ information.
• 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 regulatory
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 INNO‐
VA.
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 updat‐
ed 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 (IN‐
Tge09620)
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
49 August 5, 2010 46-017560 updated for Radiation Instruments in chapter 5

46-017561, 46-017562, 46-017563, 46-017564 updated to modify again Finali‐
zation 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 updated to in‐
troduce Discovrey IGS 730
54 January 20, 2012 46-017560, 46-017561, 46-017562, 46-017563 and 46-017564 updated to in‐
troduce Innova IGS 620, 630
12 Revision History
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 updated to in‐
troduce 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 Discovery IGS
740 and change product name to DiscoveryTM IGS 730, DiscoveryTM 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 Discovery IGS
740 and change product name to DiscoveryTM IGS 730, DiscoveryTM IGS 740
59 September 4, 2013 46-017560, 46-017561, 46-017562, 46-017563 and 46-017564 updated to in‐
troduce 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 “InnovaTM IGS 630”.
61 March 4, 2015 46-017560, 46-017561, 46-017562, 46-017563 and 46-017564 updated to in‐
troduce “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 DiscoveryTM
IGS 730 system.
Revision History 13
14 Revision History
Table of Contents
1 Collector Table of Contents.................................................................................................................17
Table of Contents 15
16 Table of Contents
1 Collector Table of Contents

Tab Document Number Rev Document Title
1 46–017559 3 HHS INTRODUCTION, OPERATING PLAN & TEST REQUIREMENT

TABLES
2 46–017560 18 HHS TOOLS
3 46–017561 29 HHS CONTROL & TUBE ASSEMBLY TESTS
4 46–017562 26 HHS BEAM QUALITY TEST
5 46–017563 33 HHS FLUORO SYSTEM TESTS
6 46–017564 25 HHS COLLIMATOR TESTS
7 46–017565 3 HHS MAMMOGRAPHY TESTS
8 46–017566 8 HHS FORMS, COMPLETING THE FDA 2579 AND GE DATA RE‐
CORD FORMS
9 46–017567 3 HHS STENOSCOP TESTS
10 46–017568 3 HHS KITS – RENEWAL PARTS
11 2257181–100 1 HHS FIELD SIGNATURE TESTS
1 Collector Table of Contents 17

18 1 Collector Table of Contents

© 2015 General Electric Company. All Rights Reserved.
General Electric Company
283, rue de la Minière
78530, Buc
FRANCE
www.gehealthcare.com
GE Healthcare
HHS
Introduction, Operating Plan and Test
Requirement Tables
46-017559
Revision 3
HHS Introduction, Operating Plan and Test Requirement Tables
GE Healthcare Direction 46-017559, Revision 3
2
LANGUAGE
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
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 18
HHS Tools and Miscellaneous Test Procedures
2
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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) updated with new 48
Victoreen tool
10 August 5, 2010 In Chapter 5, Radiation Instruments, in section “ Radiation Measuring Instru‐ 48

ments”, the following sections have been added:
• 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 introduce Optima 48
CL320i/CL323i
15 August 20, 2013 Updated to introduce Discovery IGS 740 and change product name to Discov‐ 48
eryTM IGS 730, DiscoveryTM IGS 740
16 September 4, 2013 Updated to introduce Optima IGS320 48
17 September 4, 2014 Updated to change product name to “InnovaTM IGS 620” and “InnovaTM IGS 48
630”
18 March 4, 2015 Updated to introduce “Optima IGS 330” and change product name to “Optima 48
IGS 320”
Revision History 11
12 Revision History
Table of Contents
Chapter 1 SAFETY.................................................................................................................................15
1 Safety............................................................................................................................................ 15
1.1 X-Ray Protection.................................................................................................................. 15
1.2 Certified Electrical Contractor Statement............................................................................. 16
1.3 Damage in Transportation.................................................................................................... 16
Chapter 2 REQUIRED TOOLS.............................................................................................................. 17

1 Introduction....................................................................................................................................17
2 Test Equipment Requiring Calibration...........................................................................................18
3 Calibration Services.......................................................................................................................19
3.1 Calibration Service............................................................................................................... 19
3.2 National Contracts with Medical Systems............................................................................ 19
4 Calibration and Repair Expense Accounting.................................................................................20
5 Shipment to Vendors.....................................................................................................................21
6 Return of Equipment to Headquarters for Calibration................................................................... 22
7 Calibration Responsibility.............................................................................................................. 23
Chapter 3 ALTERNATIVE FILM TESTING PROCEDURES..................................................................25

1 Introduction....................................................................................................................................25
2 REG0089 - SID Test......................................................................................................................26
3 REG0090 - Bucky/Cass. Holder Test (Collimator rotation)........................................................... 27
4 REG0091 - Bucky/Cass. Holder Test (no Collimator rotation)...................................................... 29
5 REG0092 - Light to X-Ray Field Test............................................................................................30
Chapter 4 MOUNTING FOCAL SPOT DECALS....................................................................................33

1 Mounting Focal Spot Decals..........................................................................................................33
Chapter 5 RADIATION INSTRUMENTS................................................................................................ 35

1 Radiation Measuring Instruments..................................................................................................35
1.1 MDH Models 1015 and 2025/2026.......................................................................................35
1.2 Capintec Models 192A and 174........................................................................................... 35
1.3 Victoreen Model 470A.......................................................................................................... 35

1.4 Victoreen Model 451B.......................................................................................................... 36
1.5 Unfors Xi...............................................................................................................................36
1.6 RTI Piranha.......................................................................................................................... 36
1.7 Fluke TNT12000...................................................................................................................36
1.8 Radcal Rapidose.................................................................................................................. 36
1.9 Radcal Accu-Pro...................................................................................................................37
2 REG0093 - Preliminary Set-up......................................................................................................38
3 Probe Saturation Effects................................................................................................................40
4 KVp & HVL Measuring Instruments..............................................................................................42
4.1 Unfors Xi...............................................................................................................................42
4.2 RTI Pirahna.......................................................................................................................... 42
4.3 Fluke TNT12000...................................................................................................................42
4.4 Radcal Rapidose.................................................................................................................. 42
4.5 Radcal Accu-Pro...................................................................................................................43
Chapter 6 INSTRUCTIONS FOR SETTING UP THE HHS DATA SPREADSHEET............................. 45

1 REG0094 - Setting-up of the HHS Data Spreadsheet.................................................................. 45
Chapter 1 Safety
1 Safety
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.
AMERICAS W–622
P.O. BOX 414
Chapter 1 Safety 15
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.
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).
16 1 Safety
Chapter 2 Required Tools

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 2000/2100-IQ/2121-IQ / Innova IGS 520 / InnovaTM IGS 620 / Optima IGS
320) use the 2280567 Lead Sheet suitcase.
○ (For Innova 3100/3100-IQ/3131-IQ / Innova IGS 530 / InnovaTM IGS 630 / DiscoveryTM
IGS 730 / Optima CL320i/CL323i / Optima IGS 330) use the 2408517 HHS test kit.
○ (For Innova 4100/4100-IQ / Innova IGS 540 / DiscoveryTM IGS 740) use the 2370573
HHS test kit)
3. Keithley 35080 HV Divider non-invasive (other kVpmeters (refer to Chapter 5, 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.
Chapter 2 Required Tools 17

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.
18 2 Test Equipment Requiring Calibration

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

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 2-1: 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 Service In‐ 00

strumentation
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.
20 4 Calibration and Repair Expense Accounting

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.

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.
22 6 Return of Equipment to Headquarters for Calibration

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.

24 7 Calibration Responsibility
Chapter 3 Alternative Film Testing Procedures

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.
Chapter 3 Alternative Film Testing Procedures 25

2 REG0089 - SID Test

2.1 Personnel Requirements
Personnel
Preliminary Reqs Procedure Finalization
Requirements
1 Not Applicable Not Applicable Not Applicable
2.2 Overview
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.
2.3 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.
2.4 Finalization
No finalization steps.
26 2 REG0089 - SID Test

3 REG0090 - Bucky/Cass. Holder Test (Collimator rotation)

Personnel
Requirements
3.2 Overview
If the collimator rotates on its axis it may be quicker to perform this test than the one in 46–
017564 HHS Collimator Tests.
3.3 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.
Illustration 3-1: Superimposed images from sentry collimator

3.4 Finalization
28 3 REG0090 - Bucky/Cass. Holder Test (Collimator

rotation)
4 REG0091 - Bucky/Cass. Holder Test (no Collimator rotation)

Personnel
Requirements
4.2 Overview
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.
4.3 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.
4.4 Finalization

5 REG0092 - Light to X-Ray Field Test

Personnel
Requirements
5.2 Preliminary Requirements

5.2.1 Required Conditions
Condition Reference Effectivity
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%).
5.3 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.
30 5 REG0092 - Light to X-Ray Field Test

Illustration 3-2: Light to X-Ray Field Test
5.4 Finalization


Chapter 4 Mounting Focal Spot Decals

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.
Chapter 4 Mounting Focal Spot Decals 33

34 1 Mounting Focal Spot Decals

Chapter 5 Radiation Instruments

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.
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.
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.
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: 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.
Chapter 5 Radiation Instruments 35

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.
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 cadiographic exposures (Must NOT be used for leakage and scatter
measurements).
Accuracy: + 5%, including probe energy dependency (above 50 kVp)
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.
measurements).
Accuracy: + 5%, including probe energy dependency (above 50 kVp). Refer to Section 3,Probe
Saturation Effects
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).
Saturation Effects.
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.
measurements).
Accuracy: + 5%, including probe energy dependency (above 50 kVp).
36 1 Radiation Measuring Instruments

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).
Saturation Effects.

2 REG0093 - Preliminary Set-up

Personnel
Requirements
2.2 Overview
There are five preliminary checks and setup procedures that must be followed prior to using a
meter to measure radiation.
2.3 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.
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.
38 2 REG0093 - Preliminary Set-up

Illustration 5-1: Active Volume of Probe
Illustration 5-2: Active Volume of Probe
2.4 Finalization

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 5-1: Capintec
PR-16C probe (1.6 m) 84,000 R/min – (2% error)
PM-05 probe (5 ml) 30,000 R/min – (2% error)
PM-30 probe (30 ml) 120 R/min – (2% error)
PM-500 probe (550 ml) 3 R/min – (2% error)
Table 5-2: 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
40 3 Probe Saturation Effects

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.

4 KVp & HVL Measuring Instruments

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%.
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%.
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%
measurements
Accuracy: + 2%.
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.
42 4 KVp & HVL Measuring Instruments

• 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%
measurements
Accuracy:+ 2%. or ±1.5kV
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
measurements
Accuracy:±1% or ±1kV

44 4 KVp & HVL Measuring Instruments

Chapter 6 Instructions for setting up the HHS data

spreadsheet
1 REG0094 - Setting-up of the HHS Data Spreadsheet
Personnel
Requirements
1.2 Overview
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 DiscoveryTM IGS 730, DiscoveryTM IGS 740 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.
1.3 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.
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.
Chapter 6 Instructions for setting up the HHS data 45

spreadsheet
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.
1.4 Finalization
46 1 REG0094 - Setting-up of the HHS Data Spreadsheet

78530, Buc
FRANCE
HHS
Control and Tube Assembly Tests
46-017561
Revision 29
HHS Control and Tube Assembly Tests
2
LANGUAGE


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huolto-ohjeen.











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마십시오.



nas.

pacientam.



farer.









manual de service.





lačke usluge.
vo.



ozumiete mu.

nie.



servicehandboken.
andra faror.

gotoviti prevod.

meli.



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 Ser‐ -
ies (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 modifications in Chap‐ -
ter 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 “TECHNI‐
CAL 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 updated 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
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 Innova IGS 520, 62
530, 540.
21 September 23, 2011 Update of REG0052, REG0056, REG0057 to introduce Discovery IGS 730 64
22 January 20, 2012 Update of REG0052, REG0056, REG0057 to introduce Innova IGS 620, 630 64
23 January 27, 2012 Update of REG0052, REG0056, REG0057, REG0058 for Discovery IGS 730 64
24 May 29, 2012 Update of REG0052, REG0056, REG0057 and REG0058 64
25 August 20, 2013 Update of REG0052, REG0056 and REG0057 to introduce Discovery IGS 740 64
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 Optima IGS320. 64
Also in REG0057, new P/N have been added.
Revision History 11
27 September 4, 2014 Update of REG0052, REG0056 and REG0057 to change product name to “In‐ 62
novaTM IGS 620” and “InnovaTM IGS 630”.
28 March 4, 2015 Update of REG0052 and REG0057 to introduce “Optima IGS 330” and change 62
product name to “Optima IGS 320”.
29 June 30, 2015 Update of REG0057 to introduce tool p/n 5507803 for Optima IGS systems. 62
12 Revision History
Table of Contents
1 Safety.................................................................................................................................................. 15
1.1 X-Ray Protection........................................................................................................................ 15
1.2 Certified Electrical Contractor Statement................................................................................... 16
1.3 Damage in Transportation..........................................................................................................16
2 Introduction..........................................................................................................................................17
3 REG0052 - Generator Operator Indicators......................................................................................... 18
4 REG0054 - Technique Accuracy - Generator Timer........................................................................... 22
5 REG0053 - Technique Accuracy - kV/mA........................................................................................... 23

5.3.1 Requirements.......................................................................................................................... 23
5.3.2 Procedure................................................................................................................................23
6 REG0055 - Manual mA Accuracy (Innova 2000 only).........................................................................26
7 REG0056 - Tech & Manual mA Accuracy - Tool 2389357..................................................................29

7.4.1 Acceptance Criteria – Rejection Limit......................................................................................30
7.4.2 Prerequisites............................................................................................................................31
7.4.3 Test Procedure........................................................................................................................32
7.4.3.1 mA Shunt Resistor Measurement with JEDI OFF................................................................ 32
7.4.3.2 mA Shunt Resistor Accuracy Verification.............................................................................33
7.4.3.3 Power ON the System..........................................................................................................33
7.4.3.4 Measurement procedure...................................................................................................... 33
7.4.3.5 SpreadSheet fill in procedure............................................................................................... 35
8 REG0057 - Tech & Manual mA Accuracy - Tool 2389357-2 or 5480040 or 5507803........................ 38

8.4.1 Acceptance Criteria – Rejection Limit......................................................................................40
8.4.2 Prerequisites............................................................................................................................41
8.4.3 Test Procedure........................................................................................................................42
8.4.3.1 mA shunt resistor measurement with JEDI OFF.................................................................. 42
8.4.3.2 mA Shunt resistor accuracy verification............................................................................... 42
8.4.3.3 Power ON the System..........................................................................................................42

8.4.3.4 Measurement procedure...................................................................................................... 43
8.4.3.5 SpreadSheet fill in procedure............................................................................................... 44
9 REG0058 - Technique Accuracy - kV (21, 31 & 41 cm Detector)....................................................... 47
10 REG0059 - Technique Accuracy - mAs............................................................................................ 51
11 REG0060 - Indirect Linearity............................................................................................................. 52
12 REG0061 - AEC Maximum mAs....................................................................................................... 53

12.4.1 For Advantx Systems............................................................................................................ 53
12.4.2 For Non-Advantx Systems.....................................................................................................53
12.4.3 Record Data.......................................................................................................................... 53
13 REG0062 - AEC Minimum Exposure Time....................................................................................... 54
14 REG0063 - Reproducibility Of Exposure...........................................................................................55

14.4.1 Procedure 1 - For exposures made with an A.E.C................................................................55
14.4.2 Procedure 2 - For exposures made without the use of A.E.C............................................... 56
14.4.3 Procedure 3 - For tomographic systems............................................................................... 56
15 REG0064 - Direct Linearity Of Exposure Alternate Method.............................................................. 58

15.4.1 Requirements........................................................................................................................ 58
15.4.2 Procedure..............................................................................................................................58
1 Safety
WARNING
EQUIPMENT IN USE.
DEVICES BE USED.
CAUTION
physician.
AMERICAS W–622
P.O. BOX 414
1 Safety 15

16 1 Safety
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.
Illustration 1:
2 Introduction 17
3 REG0052 - Generator Operator Indicators

Personnel
Requirements
1 Not Applicable 40 mins Not Applicable
3.2 Overview
Application
All X-Ray controls at installation and preventive maintenance calls, or when replacing major
components.
DiscoveryTM IGS 730, DiscoveryTM IGS 740 systems are also named DiscoveryTM IGS Systems.
The procedure is applicable indifferently to DiscoveryTM IGS 730 or DiscoveryTM IGS 740.
When two or more X–Ray tubes are - Innova IGS
controlled by the same exposure switch 620 and
(hand or foot), indicator lamps shall be Innova IGS
mounted on the tube units to indicate the 630
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 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,
Fluoro 5 minute timer termination.
X-Ray warning label shall be present. - -
18 3 REG0052 - Generator Operator Indicators

3.4 Procedure
1. (Not applicable to DiscoveryTM IGS 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.
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, DiscoveryTM IGS 730, DiscoveryTM IGS 740, Optima CL320i/
CL323i, 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. Check that the audible and visual warnings raise in control/exam rooms
(i.e. on VCIM and TSSC) 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.
NOTE: Start the time measurement when image is displayed on monitor for both cases.
4. X–Ray Timer for Innova 2121-IQ and Innova 3131-IQ systems, InnovaTM IGS 620 and
InnovaTM IGS 630:
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
3 REG0052 - Generator Operator Indicators 19

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.
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 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.
NOTE: Start the time measurement when image is displayed on monitor for both cases.
5. 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).
3.5 Finalization

4 REG0054 - Technique Accuracy - Generator Timer

Personnel
Requirements
4.2 Overview
Application
All X-Ray units, (except those having only mAs selection capability, for such units, refer to
REG0053 - Technique Accuracy - kV/mA), at installation, periodic maintenance calls, and when
repairing timer.
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 operating manual).
4.4 Procedure
1. This test is performed at the same time as the kV/mA accuracy test, refer to REG0053 -
Technique Accuracy - kV/mA.
2. Record data on Form F3382.
Illustration 2: kV/mA Accuracy Chart
4.5 Finalization
22 4 REG0054 - Technique Accuracy - Generator Timer

5 REG0053 - Technique Accuracy - kV/mA

Personnel
Requirements
5.2 Overview
Application
kVp and mA accuracy: At installation, periodic maintenance, and repair.
kVp and mA accuracy applies to all tubes in system.
5.3 Procedure
5.3.1 Requirements
NOTE: 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.
5.3.2 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 Illustration 3,Illustration 4 and Illustration 5). Turn unit on
and select tube to be checked, leaving both energized continuously. Wait 1 hour and 15
minutes before making measurements.
5 REG0053 - Technique Accuracy - kV/mA 23

Illustration 3: Detector Positioning for kVp Measurement
Illustration 4: Detector Positioning (vertical) for kVp Measurement
24 5 REG0053 - Technique Accuracy - kV/mA

Illustration 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.
5.4 Finalization
5 REG0053 - Technique Accuracy - kV/mA 25

6 REG0055 - Manual mA Accuracy (Innova 2000 only)

Personnel
Requirements
6.2 Overview
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
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.
6.3 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%).
26 6 REG0055 - Manual mA Accuracy (Innova 2000 only)

Table 1:
fps kVp mAs (mA) PW Average mA de‐ Average mA % difference

mand feedback
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.
Cardiac acquisition.
10. Log in the table below the VAMP value and the technics feedback displayed on the status
result of this test is Ok when the % difference is within the range (–20%, +20%).
Table 2:

mand feedback
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.
6 REG0055 - Manual mA Accuracy (Innova 2000 only) 27

15. Log in the table below the VAMP value and the technics feedback displayed on the status
result of this test is Ok when the % difference is within the range (–20%, +20%).
Table 3:

mand feedback
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.
6.4 Finalization
28 6 REG0055 - Manual mA Accuracy (Innova 2000 only)

7 REG0056 - Tech & Manual mA Accuracy - Tool 2389357

Personnel
Requirements
7.2 Overview
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, InnovaTM IGS 620, InnovaTM IGS 630 and
DiscoveryTM IGS 730, DiscoveryTM IGS 740.
This test plan will be performed in all following cases:
• System installation
• System repair
Purpose
The tests described (see Table 4 and Table 5) 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).
7.3.1 Tools and Test Equipment
Item Qty Effectivity Part# Manufacturer
Detector Lead Blocker 1 - 2337600 -

2389357

JEDI mA shunt 1 - 2389357 -
measurement external tool
JEDI tool cover 1 All systems 2404211 -
JEDI tool cover 1 Innova single 2404211-20 -
plane and
DiscoveryTM
IGS systems
Standard Field Engineering 1 - - -
Tools with metric and US
wrenches
Fluke 87 serie 3 multimeter 1 - - -
7.3.2 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 computed - -
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 updated at - -
exposure end, available in the X220 status
bar, should be within ± 20% of the
mA_Average Demand value.
7.4 Procedure
7.4.1 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).
• (For Innova)
If your system is equipped with 24 meters HV cables - Fill in the spreadsheet with correction
related to mA_Average correction 24 m.
30 7 REG0056 - Tech & Manual mA Accuracy - Tool

2389357
• (For Innova)
• (For DiscoveryTM IGS 730, DiscoveryTM IGS 740)

Fill in the spreadsheet with correction related to mA_Average correction 28.70 m.
7.4.2 Prerequisites
1. Switch OFF the system.
WARNING
BEFORE REMOVING JEDI INVERTER COVER, WAIT UNTIL ALL LED’S ARE
EXTENGUISH ON JEDI AC/DC BD
2. For Single Plane, open C1 Cabinet (for Biplane, open C1 FRT or C1 LAT Cabinet) and
remove the JEDI inverter cover (refer to DR0187 - Jedi KVCTL Board, steps 1 to 4 of the
Disassembly procedure).
3. Install the JEDI cover tool (2404211): put in place the plastic cover tool for JEDI inverter
protection .
Illustration 6: Connection of the JEDI mA Shunt Measurement Tool
4.
Remove the flat cable in J1 of KVCTL board ( , Illustration 6).

2389357
5.
Plug the J1 of the JEDI mA shunt measurement tool (2389357) in the J1 connector of the
KVCTL board.
Illustration 7: mA Measurement Tool (2389357) and Multimeter Connection
6. Plug the flat cable in the JEDI mA shunt measurement tool (male side, connetor J3).
7.
Connect the cables ( , Illustration 7) of the multimeter ( , Illustration 7) to the connector
J4 of the JEDI mA shunt measurement tool.
7.4.3 Test Procedure
7.4.3.1 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).

2389357
7.4.3.2 mA Shunt Resistor Accuracy Verification

1. Record and compile values according to Table 4 and Table 5.
2. The rejection limit is 5 ohms ± 2%.
7.4.3.3 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.
7.4.3.4 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 Illustration 8).
a. Enter in the SUIF (on the DL browser, click on the knife tool icon).

2389357
Illustration 8: 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).
4. Choose exposure technics parameters according to the Tables listed below.
Table 4: Test Angio Parameters
Fluke 87 serie 3 Test 1 Test 2 Test 3 Test 4 Test 5 Test 6

Range Meas‐
urement on 4
Vdc
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 Leave Empty

LONG
Collimator LAT Leave Empty

2389357
Table 5: Test Cardiac Parameters
Fluke 87 serie 3 Range Test 7 Test 8 Test 9 Test 10

Measurement on 4 Vdc
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
Collimator LONG Leave Empty
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 Illustration 8).
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.
13. When all tests are performed, click on ABORT to exit.
7.4.3.5 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:

2389357
• 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 DiscoveryTM IGS 730, DiscoveryTM IGS 740 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 rejection
rection value rection value rection value limit (–15% of mand value limit (+15% of
@ 24 m HV @ 28.70 m HV @ 30 m HV mA_avg De‐ (mA) mA_avg De‐
cable (mA) cable (mA) cable (mA) mand) (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
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.

2389357
WARNING
BEFORE REMOVING JEDI INVERTER COVER TOOL, WAIT UNTIL ALL

LED’S ARE EXTINGUISHED ON JEDI AC/DC BD.
b. Remove the multimeter.
c. Remove the inverter cover tool (2404211).
d. Remove the mA shunt tool (2389357).
e. Reinstall the flat cable in the J1 connector.
f. Reinstall the Inverter metallic cover (refer to DR0187 - Jedi KVCTL Board,
Reassembly procedure).
g. Close Auxiliary ACDC assembly in the C1 cabinet.
h. Remove the Lead Blocker.
i. Switch ON the system.
j. Carry out an X–ray expose to control the system operation.
7.5 Finalization

2389357
8 REG0057 - Tech & Manual mA Accuracy - Tool 2389357-2 or 5480040 or

5507803
Personnel
Requirements
8.2 Overview
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, InnovaTM IGS 620, InnovaTM IGS 630,
DiscoveryTM IGS 730, DiscoveryTM IGS 740, Optima CL320i/CL323i, Optima IGS 320 and
Optima IGS 330.
This test plan will be performed in all following cases:
• System installation
• System repair
Purpose
The tests described (see Table 6 and Table 7) 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 2389357-2 & 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.

2389357-2 or 5480040 or 5507803

Detector Lead Blocker 1 Innova and 2337600 -
DiscoveryTM
IGS Systems,
41 cm detector
Detector Lead Blocker 1 Innova and 2396564 -
DiscoveryTM
IGS Systems,
31 cm detector
Detector Lead Blocker 1 Innova 5125039 -
systems, 21
cm detector
Detector Lead Blocker 1 Optima 5413024 -
CL320i/CL323i
and Optima
IGS 330
Detector Lead Blocker 1 Optima IGS 5488772 -
320
JEDI mA measurement 1 Innova, 2389357-2 -
external tool Optima and
DiscoveryTM
IGS Systems
JEDI mA measurement 1 Optima 5480040 -
external tool Systems
JEDI mA measurement 1 Optima 5507803 -
external tool Systems
JEDI tool cover 1 All systems 2404211 -
JEDI tool cover 1 Innova single 2404211-20 -
plane and
DiscoveryTM
IGS systems
JEDI tool cover 1 Optima IGS 5480038 -
systems
Standard Field Engineering 1 - - -
Tools with metric and US
wrenches

2389357-2 or 5480040 or 5507803

Multimeter with voltage 1 - - -
accuracy ≤ 0.1 %. A
multimeter with min/max
function is preferred for
easy use.
8.3.2 Safety
WARNING
RESIDUAL VOLTAGE PRESENT
The X–Ray tube mA _ Average computed - -
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 updated at - -
exposure end, available in the X220 status
bar, should be within ± 20% of the
mA_Average Demand value.
8.4 Procedure
8.4.1 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 and Optima Systems)
• (For Innova and Optima Systems)

• (For DiscoveryTM IGS 730, DiscoveryTM IGS 740)

Fill in the spreadsheet with correction related to mA_Average correction 28.70 m.

2389357-2 or 5480040 or 5507803
8.4.2 Prerequisites
1. Switch OFF the system.
WARNING
BEFORE REMOVING JEDI INVERTER COVER, WAIT UNTIL ALL LED’S ARE
EXTENGUISH ON JEDI AC/DC BD
2. For Single Plane, open C1 Cabinet (for Optima IGS systems, open System control cabinet;
for Biplane, open C1 FRT or C1 LAT Cabinet) and remove the JEDI inverter cover, refer to:
(For Innova and DiscoveryTM IGS Systems) DR0187 - Jedi KVCTL Board, steps 1 to 4 of
the Disassembly procedure.
(For Optima Systems) DR0871 - Jedi KVCTL Board, steps 1 to 4 of the Disassembly
procedure.
3. Install the JEDI cover tool (2404211 or 2404211-20 or 5480038): put in place the plastic
cover tool for JEDI inverter protection .
Illustration 9:
4.
Remove the flat cable in J1 of KVCTL board ( , Illustration 9).
5.
Plug the J1 of the JEDI mA shunt measurement tool (2389357-2 or
5480040/5507803) in the J1 connector of the KVCTL board.

2389357-2 or 5480040 or 5507803
Illustration 10:
6.
Plug the flat cable in the JEDI mA shunt measurement tool (male side, connector J3) ( ,
Illustration 10).
7.
Connect the cables ( , Illustration 10) of the multimeter ( , Illustration 10) to the banana
plugs (mA and shunt–B) of the JEDI mA shunt measurement tool.
8.4.3 Test Procedure
8.4.3.1 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).
8.4.3.2 mA Shunt resistor accuracy verification
2. The rejection limit is 5 ohms ± 2%.
8.4.3.3 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.

2389357-2 or 5480040 or 5507803
8.4.3.4 Measurement procedure

1. Put in place the DLB (Detector Lead Blocker).
2. Select the multimeter in Vdc voltage function.
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 Illustration 11).
a. Enter in the SUIF (on the DL browser, click on the knife tool icon).
Illustration 11:
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 6: Test Angio Parameters
Multimeter Test 1 Test 2 Test 3 Test 4 Test 5 Test 6

Range Meas‐
urement on Vdc
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

2389357-2 or 5480040 or 5507803
Multimeter Test 1 Test 2 Test 3 Test 4 Test 5 Test 6

Range Meas‐
urement on Vdc
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 Leave Empty

LONG
Table 7: Test Cardiac Parameters
Multimeter Range Test 7 Test 8 Test 9 Test 10

Measurement on Vdc
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
Collimator LONG Leave Empty
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.
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.
8.4.3.5 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.

2389357-2 or 5480040 or 5507803
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
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 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 730, DiscoveryTM IGS 740 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 rejection mA_avg De‐ USL rejection
rection value rection value rection value limit (–12% of mand value limit (+12% of
@ 24 m HV @ 28.70 m HV @ 30 m HV mA_avg De‐ (mA) mA_avg De‐
cable (mA) cable (mA) cable (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

2389357-2 or 5480040 or 5507803
3. Removal the mA Shunt Tool and JEDI Cover Tool

a. Switch OFF the system.
WARNING
BEFORE REMOVING JEDI INVERTER COVER TOOL, WAIT UNTIL ALL

LED’S ARE EXTINGUISHED ON JEDI AC/DC BD.
b. Remove the multimeter.
c. 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.
f. Reinstall the Inverter metallic cover, refer to:
(For Innova and DiscoveryTM IGS Systems) DR0187 - Jedi KVCTL Board,
Reassembly procedure.
(For Optima Systems) DR0871 - Jedi KVCTL Board, Reassembly procedure.
g. Close Auxiliary ACDC assembly in the C1 cabinet (or System control cabinet for
Optima IGS systems).
h. Remove the Lead Blocker.
i. Switch ON the system.
j. Carry out an X–Ray expose to control the system operation.
8.5 Finalization

2389357-2 or 5480040 or 5507803
9 REG0058 - Technique Accuracy - kV (21, 31 & 41 cm Detector)

Personnel
Requirements
1 10 mins 45 mins 10 mins
9.2 Overview
• 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.

Non-invasive divider with an 1 - - -
accuracy ≤ ± 3% as
recommended in
Illustrations of this
procedure
9.3.2 Safety
WARNING
RISK OF ELECTRIC SHOCK
HAZARDOUS VOLTAGE PRESENT
WARNING
BEFORE ANY INTERVENTION SWITCH OFF THE SYSTEM.
WARNING
WARNING - REZIDUAL VOLTAGE PRESENT
9.4 Procedure
1. Use the non–invasive divider with an accuracy =< ± 3% as recommended in Illustrations
below.
9 REG0058 - Technique Accuracy - kV (21, 31 & 41 cm 47

Detector)
Illustration 12: Detector Positioning for kVp Measurement
Illustration 13: 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
48 9 REG0058 - Technique Accuracy - kV (21, 31 & 41 cm

Detector)
d. kVpeak, mApeak, Pulse Width: Refer to Table 8.

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 DiscoveryTM IGS Systems) DR0187 - Jedi KVCTL Board
(For Optima Systems) DR0871 - Jedi KVCTL Board
or (and) the HV tank, refer to:
(For Innova and DiscoveryTM IGS Systems) DR0191 - Jedi Inverter or HV Tank
(For Optima Systems) DR0874 - Jedi Inverter or HV Tank
Table 8:
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) =
Displayed kVp) Displayed
kVp x 0.93 kVp x 1.07
Test 1 75 150 100 3.75
Test 2 100 150 100 3.75
Illustration 14:
7. Record the data (apply any corrective factor if required and check final results are within
9 REG0058 - Technique Accuracy - kV (21, 31 & 41 cm 49

Detector)
9.5 Finalization
50 9 REG0058 - Technique Accuracy - kV (21, 31 & 41 cm

Detector)
10 REG0059 - Technique Accuracy - mAs

Personnel
Requirements
10.2 Overview
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.
When the equipment is connected to an Operating Manual -
deviation of the tube current/exposure
time product shall not exceed the limits
given in specifications.
10.4 Procedure
1. Procedures for making this test are given in the individual service manual functional check.
Also refer to REG0054 - Technique Accuracy - Generator Timer.
2. Record data: enter required data on Form 3382 on laptop computer.
10.5 Finalization
10 REG0059 - Technique Accuracy - mAs 51

11 REG0060 - Indirect Linearity

Personnel
Requirements
11.2 Overview
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.

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, this section is also
satisfied and no further testing is
necessary.
11.4 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.
2. Ensure the test is passed.
11.5 Finalization
52 11 REG0060 - Indirect Linearity

12 REG0061 - AEC Maximum mAs

Personnel
Requirements
12.2 Overview
Application
X-Ray units with AEC at installation, and periodic maintenance. Does not apply to image
intensifiers.
At tube potentials of 50 kV or more, - -
exposures may not exceed 600 mAs per
exposure: below 50 kV, exposures may
not exceed 2,000 mAs. Requirements do
not apply under any type of equipment
failure mode.
12.4 Procedure
12.4.1 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.
12.4.2 For Non-Advantx Systems
Procedure is covered in the Functional Check chapter of the appropriate generator or automatic
exposure control service manual.
12.4.3 Record Data
Record that requirements have been met on laptop computer Form 3382.
12.5 Finalization
12 REG0061 - AEC Maximum mAs 53

13 REG0062 - AEC Minimum Exposure Time

Personnel
Requirements
13.2 Overview
Application
X-Ray units with AEC, at installation and periodic maintenance. Does not apply to image
intensifiers.
At 50 kV or more, minimum exposures - -
must be less than 16 ms or less than the
time to deliver 5 mAs, whichever time is
greater.
13.4 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.
13.5 Finalization
54 13 REG0062 - AEC Minimum Exposure Time

14 REG0063 - Reproducibility Of Exposure

Personnel
Requirements
14.2 Overview
Application
At installation, preventive maintenance, and repair.
Radiation meter with 1 - - -
integrate mode.
Probe test stand. 1 - - -
14.3.2 Consumables
1–1/2 (3.8 cm) thickness of AR - - -
aluminum (from HHS kit),
for use with A.E.C. systems
only.

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.
14.4 Procedure
14.4.1 Procedure 1 - For exposures made with an A.E.C
If system passes Section 14.4.1, there is no need to perform Section 14.4.2. Follow the
instructions that pop up on the laptop computer Form 3382 for this test.
14 REG0063 - Reproducibility Of Exposure 55

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.
NOTE: Test is applicable at any kVp and mA setting.
4. 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.
14.4.2 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. 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.
14.4.3 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.
56 14 REG0063 - Reproducibility Of Exposure

defective ion chamber.
Table 9: Mini-Troubleshooting Guide
Problem Possible Cause
Coefficient of variation too high • Poor kVp reproducibility (deadband). In AEC mode this
affects kVp compensation on some systems.
• Improper rotor acceleration delay, improper spotfilm

transfer delay, improper filament boost. All of these will
determine if filament is up to temperature when expo‐
sure occurs. On AEC systems, a variable filament tem‐
perature 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.
14.5 Finalization
14 REG0063 - Reproducibility Of Exposure 57

15 REG0064 - Direct Linearity Of Exposure Alternate Method

Personnel
Requirements
15.2 Overview
Application - For radiographic modes without AEC:
At installation, preventive maintenance, and repair. Use this method whenever indirect linearity
test fails.
integrated mode.
Probe test stand 1 - - -
15.4 Procedure
15.4.1 Requirements
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).
15.4.2 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.
58 15 REG0064 - Direct Linearity Of Exposure Alternate

Method
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 10.
Table 10: Mini–Troubleshooting Guide
C.L. too high • mA accuracy out of specification.
• Timer accuracy out of specification.
• Probe saturation (refer to REG0052 - Generator Opera‐

tor Indicators, 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.
Illustration 15: Direct Linearity Chart
15.5 Finalization
15 REG0064 - Direct Linearity Of Exposure Alternate 59

Method
60 15 REG0064 - Direct Linearity Of Exposure Alternate

Method
78530, Buc
FRANCE
HHS
Beam Quality Test
46-017562
Revision 26
HHS Beam Quality Test
2
LANGUAGE


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마십시오.



nas.

pacientam.



farer.









manual de service.





lačke usluge.
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servicehandboken.
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gotoviti prevod.

meli.



Revision History
1 May 24, 1995 Note added to recording data. -
2 Apr. 30, 1996 Minor updates. -
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
23 August 20, 2013 Update of REG0065 to introduce Discovery IGS 740 and change product 28
name to DiscoveryTM IGS 730, DiscoveryTM 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 “Innova TM

IGS 620” and “Inno‐ 28
vaTM IGS 630”
26 March 4, 2015 Update of REG0065 to introduce “Optima IGS 330 and change product name 28
to “Optima IGS 320”.
Revision History 11
12 Revision History
Table of Contents
1 Safety.................................................................................................................................................. 15
1.1 X-Ray Protection........................................................................................................................ 15
2 REG0065 - Beam Quality Test............................................................................................................17

2.3.1 Requirement............................................................................................................................17
2.3.2 Procedure................................................................................................................................18
2.3.3 Acceptance Criteria for Vascular Systems (not applicable to Innova, Optima and
DiscoveryTM IGS Systems)............................................................................................ 22
2.3.4 Recording Data........................................................................................................................23
3 REG0066 - Beam Quality Test - Graphical Method............................................................................ 24
1 Safety
WARNING
EQUIPMENT IN USE.
DEVICES BE USED.
CAUTION
physician.
AMERICAS W–622
P.O. BOX 414
1 Safety 15

16 1 Safety
2 REG0065 - Beam Quality Test

Personnel
Requirements
2.2 Overview
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.
2.3 Procedure
2.3.1 Requirement
1. The half–value layer of useful beam at a given kVp shall not be less than that shown in the
following table. These requirements are from 21CFR part 1020.30 (m). Specific test point is
at 80 kVp, thus the minimum half–value layer requirement is 2.3 mm of aluminum for
systems manufactured before June 10th, 2006. The minimum half–value layer for systems
manufactured On or After June 10th, 2006 is 2.9 mm aluminum @ 80 kVp
Table 1: Minimum Half-Value Layer
Design Operating Selected kVp Minimum Half-Value Layer (Millimeters of Minimum Half-Value Layer (Millimeters of
Range (Kilovolts Aluminum)** For Systems manufactured Aluminum)** For Systems manufactured
Peak) before June 10th, 2006 on or after 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
2 REG0065 - Beam Quality Test 17

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 2: System Specific Details
Standard Absorber Total Test Aluminum Filtration Total Test Aluminum Filtration
Before June 10th, 2006 in mil‐ On or After June 10th, 2006 in
limeters millimeters
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

• 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.
2.3.2 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.

• 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.
18 2 REG0065 - Beam Quality Test

1. 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.
Illustration 1: Half Value Layer - Good Geometry
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.

Illustration 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.
NOTE: For all Innova, Optima and DiscoveryTM IGS Systems, 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.
5. 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.


• For Innova 2000 Systems, select the fixed point HHS1, center the probe
while making exposures and collimate to probe volume. Then go to the
Next Page and select row: 80 kVp, 0.0667 mAs, 10 ms, FS=0.6, Spectral
filter=0. Leave field for LONG/LAT empty to keep previous collimator
settings.
• For Innova 2100-IQ/2121-IQ, Innova 3100/3100-IQ/3131-IQ, Innova

4100/4100-IQ systems, Innova IGS 520, 530, 540, InnovaTM IGS 620,
InnovaTM IGS 630, DiscoveryTM IGS 730, DiscoveryTM IGS 740, Optima
CL320i/CL323i, Optima IGS 320 and Optima IGS 330, set the techniques
below (and click [Submit] button), center the probe while making
exposures and collimate to probe volume by reducing the Collimator
LONG/LAT values (click [Submit] button to validate changes).
Table 3:
Exp.Mode Frame Focal kVp mA Pulse Width Spectral Fil‐ DLB Presence LONG LAT
Rate Spot peak ter
Fluoro 30 0.6 60 1 2 None No 4000/3000
Then, set the following technics (and click [Submit] button) for measurement phase:
Table 4:
Exp.Mode Frame Focal kVp mA Pulse Width Spectral Fil‐ DLB Presence LONG LAT
Rate Spot peak ter
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 5 for
action.
Table 5:
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 and DiscoveryTM IGS Systems the 0.57 ratio value may
be exceeded on purpose and reach up to 0.7.

NOTE: **For Rad and R & F systems utilizing the Siemens Collimator, filtration cannot
be added. The collimator design does not support this:
• Verify kVp Accuracy.
• Verify test setup is correct. This is the most common error.
• Verify test equipment is functioning properly and within calibration.
• Issues reside at the system level interactions. Detailed analysis must be

performed to identify root cause of failure.
Collimators with mirrors usually require no additional filtration but, on the other hand,
excess filtration may not be removed. Filtration may only be removed if separate sheets
were previously added. The required change in filtration may be estimated as 0.5 mm for
each desired 0.05 change in ratio. For example, if the ratio is 0.48 the addition of 0.5 mm
of aluminum will raise the ratio by approximately 0.05 to a new ratio of approximately
0.53. Re–test the system after adding filtration.
Fixed filters must be Type 1100 aluminum and should be mounted between the tube unit
and collimator whenever possible. If not possible (example: lead fingers of collimator
interfere), mount elsewhere between source and patient, but use piece large enough to
intercept entire beam, and mount permanently. A good mounting area in the Sentry
Collimator is the back of the mirror. Use a good quality adhesive such as contact cement
or epoxy. Since the filter will be at a 45 angle to the beam, use only about 0.7 of the
thickness of aluminum that is calculated. Recheck HVL before mounting permanently
(use tape for temporary mounting).
HVL too high [>0.57] or [>0.7 (for Inno‐ kVp incorrect (high)
va, Optima and DiscoveryTM IGS Sys‐
tems)] Meter error – probe saturation, see REG0066 - Beam Quality Test - Graphical
Method.
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, InnovaTM IGS 620, InnovaTM IGS
630, DiscoveryTM IGS systems, Optima CL320i/CL323i, Optima IGS 320 and Opti‐
ma IGS 330, check that the spectral filter has been set to 'None’.
HVL too low kVp incorrect (low).
Not enough filtration.
2.3.3 Acceptance Criteria for Vascular Systems (not applicable to Innova, Optima and
DiscoveryTM IGS Systems)
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 7:
Measured kVp 75 76 77 78 79 80 81 82 83 84 85
Min Ratio .519 .523 .526 .529 .533 .536 .540 .543 .546 .550 .553
Max Ratio .545 .549 .552 .555 .559 .562 .566 .569 .572 .576 .579
2. If a 1 kVp accuracy kVp meter was not used, the acceptance criteria is:
• CDRH REQT @ 80 KV: DOSE RATIO > 0.52
• IMAGING REQT: DOSE RATIO < 0.57

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

3 REG0066 - Beam Quality Test - Graphical Method

Personnel
Requirements
3.2 Overview
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.
3.3 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
example of a graph for half value layer.) You should be able to draw a straight line through
the points.
24 3 REG0066 - Beam Quality Test - Graphical Method

Illustration 3:
3 REG0066 - Beam Quality Test - Graphical Method 25

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.
4. Mark the point where the line ofStep 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.
3.4 Finalization
26 3 REG0066 - Beam Quality Test - Graphical Method

78530, Buc
FRANCE
HHS
Fluoro Systems Tests
46-017563
Revision 33
HHS Fluoro Systems Tests
2
LANGUAGE


伤害。
險。
傷。













huolto-ohjeen.











og skilin.


い。


마십시오.



nas.

pacientam.



farer.









manual de service.





lačke usluge.
vo.



ozumiete mu.

nie.



servicehandboken.
andra faror.

gotoviti prevod.

meli.



Revision History
1 Apr. 30, 1996 Minor updates. -
2 Dec. 1, 1997 Revised to include hardcopy form references for third party 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’ replaces ’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 Leakage Radiation up‐ -
dated 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).
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 new Victoreen 44
tool
21 May 5, 2010 Updated to modify Finalization sections of REG0067 and REG0069 50
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
Revision History 11
25 July 27, 2011 Update of REG0067 and REG0070 to introduce Innova IGS 520, 530, 540 44
26 September 26, 2011 Update of REG0067, REG0069 and REG0070 to introduce Discovery IGS 730 44
27 January 20, 2012 Update of REG0067, REG0069 and REG0070 to introduce Innova IGS 620, 44
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 CL320i/CL323i 46
30 August 20, 2013 Update of REG0067, REG0069 and REG0070 to introduce Discovery IGS 740 46
and change product name to DiscoveryTM IGS 730, DiscoveryTM IGS 740
31 September 4, 2013 Update of REG0067, REG0069 and REG0070 to introduce Optima IGS320. 46
32 September 4, 2014 Update of REG0067, REG0069 and REG0070 to change product name to “In‐ 42
novaTM IGS 620” and “InnovaTM IGS 630”
33 March 4, 2015 Update of REG0067, REG0069 and REG0070 to introduce “Optima IGS 330” 42
and change product name to “Optima IGS 320".
12 Revision History
Table of Contents
1 Safety.................................................................................................................................................. 15
1.1 X-Ray Protection........................................................................................................................ 15
2 REG0067 - Fluoro Entrance Exposure Rate....................................................................................... 17

2.3.1 Requirements.......................................................................................................................... 17
2.3.2 Procedure................................................................................................................................17
3 REG0068 - Primary Barrier Transmission...........................................................................................22

3.4.1 Procedure................................................................................................................................23
3.4.2 Record Data............................................................................................................................ 27
4 REG0069 - Primary Barrier Transmission (21, 31 & 41 cm Detector).................................................28

4.4.1 Gantry Preparation.................................................................................................................. 30
4.4.1.1 Case Innova 2000 without capacitive sensors..................................................................... 30
4.4.1.2 Case Innova 2000 with capacitive sensors.......................................................................... 30
4.4.1.3 Case system with 21 cm detector.........................................................................................30
4.4.1.6 Case system with 21 cm detector (biplane)......................................................................... 30
4.4.1.7 Case system with 31 cm detector (biplane)......................................................................... 31
4.4.2 Tool Installation....................................................................................................................... 31
4.4.2.1 3.8 cm attenuation block assembly installation.................................................................... 31
4.4.2.2 Scatter lead shield................................................................................................................32
4.4.3 Measurement preparation for Innova 2000............................................................................. 32
4.4.4 Measurement preparation for Innova 2100-IQ / 3100/3100-IQ / 4100/4100-IQ / 2121-
IQ / 3131-IQ, Innova IGS 520, 530, 540, InnovaTM IGS 620, InnovaTM IGS 630,
DiscoveryTM IGS 730, DiscoveryTM IGS 740, Optima CL320i/CL323i, Optima
IGS 320 and Optima IGS 330....................................................................................... 33
4.4.5 Measurements.........................................................................................................................34
4.4.6 Reject criteria...........................................................................................................................34
5 REG0070 - Tube Leakage Radiation.................................................................................................. 35
6 Fluoro Interlocks..................................................................................................................................40
6.1 Application..................................................................................................................................40
6.2 Requirement...............................................................................................................................40
6.3 Procedure...................................................................................................................................40
6.4 Record Data............................................................................................................................... 40
1 Safety
WARNING
EQUIPMENT IN USE.
DEVICES BE USED.
CAUTION
physician.
AMERICAS W–622
P.O. BOX 414
1 Safety 15

16 1 Safety
2 REG0067 - Fluoro Entrance Exposure Rate

Personnel
Requirements
2.2 Overview
All fluoroscopic image receptors, at installation, repair, preventive maintenance, or replacement
of X–ray tube or HV transformer.
2.3 Procedure
2.3.1 Requirements
1. See Table 1. Note that, in practice, the rejection limits for entrance exposure rate must be
somewhat less than shown in Table 1 due to R–meter calibration accuracy. See Table 2.
Table 1: Maximum Exposure Rates
Mode Systems manufactured after 5/95 Systems manufactured before 5/95
Fluoro, System W/O Hi-level control 87.6 mGy/min (10 R/min, auto or man‐ 87.6 mGy/min (10 R/min, auto or man‐
ual) ual)
Fluoro, System W Hi-level control and 175 mGy/min (20 R/min, auto or manual) No limit
Hi-level is active
Fluoro, System W Hi-level control and 87.6 mGy/min (10 R/min, auto or man‐ 43.8 mGy/min (5 R/min, auto or manual)
Hi-level is not active ual)
Recording Modes No limit No limit
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.
Table 2: 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)
2.3.2 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.
2 REG0067 - Fluoro Entrance Exposure Rate 17

Illustration 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.
18 2 REG0067 - Fluoro Entrance Exposure Rate

Illustration 2: Test set-up - overtable source, Fluoro entrance exposure rate
Illustration 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.

Illustration 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, InnovaTM IGS 620, InnovaTM IGS 630, DiscoveryTM IGS 730, DiscoveryTM
IGS 740, Optima CL320i/CL323i, 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, InnovaTM IGS 620, InnovaTM IGS 630,
DiscoveryTM IGS 730, DiscoveryTM IGS 740, Optima CL320i/CL323i, 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.
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. SkipStep 7 and Step 8.

Table 3:
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,
InnovaTM IGS 620, InnovaTM IGS 630, DiscoveryTM IGS 730, DiscoveryTM IGS
740, Optima CL320i/CL323i, 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: For Innova 2000, Innova 2100-IQ/2121-IQ, Innova 3100/3100-IQ/3131-IQ,
Innova 4100/4100-IQ, Innova IGS 520, 530, 540, InnovaTM IGS 620, InnovaTM
IGS 630, DiscoveryTM IGS 730, DiscoveryTM IGS 740, Optima CL320i/CL323i,
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: For Innova 2000, Innova 2100-IQ/2121-IQ, Innova 3100/3100-IQ/3131-IQ,
Innova 4100/4100-IQ, Innova IGS 520, 530, 540, InnovaTM IGS 620, InnovaTM
IGS 630, DiscoveryTM IGS 730, DiscoveryTM IGS 740, Optima CL320i/CL323i,
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.
High Fluoro Insufficient filtration (HVL too low)
Entrance Probe not centered
Exposure Rate Incorrect set-up
2.4 Finalization

3 REG0068 - Primary Barrier Transmission

Personnel
Requirements
3.2 Overview
All fluoroscopic imaging assemblies, at installation, repair, or preventive maintenance.
Victoreen 470 A survey 1 - -
meter
or Victoreen 451B survey 1 - 5270475 -
meter

The exposure rate due to transmission - -
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 beyond 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.
Test data may be entered into the Laptop 46–017566 HHS Forms, -
3382 spreadsheet program, or if this is not completing the FDA 2579 and
available, it may be recorded in Form GE data record forms
3382.
22 3 REG0068 - Primary Barrier Transmission

3.4 Procedure
3.4.1 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.
Illustration 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.
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.
3 REG0068 - Primary Barrier Transmission 23

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.)
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.)
Illustration 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.
1. 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 Illustration 6.
2. 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).
3. 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 Illustration 5, Illustration 10 and Illustration 11 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 Illustration 5 , Illustration 10 and Illustration 11 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:
Illustration 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.
Illustration 8:
1. 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.

Illustration 9:
2. Wait for 4 minutes for a complete warm up (that operation is critical as

doses measured behind primary barrier are very low).
3. 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
Illustration 5, as appropriate for the equipment.
Illustration 10: Test Set-up - Overtable Lateral Source or C-arm, or LU arm, Primary
Barrier Transmission

Illustration 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 Illustration 5,Illustration 10 andIllustration 11 for typical
placement of air scatter shield.
3.4.2 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.
3.5 Finalization

4 REG0069 - Primary Barrier Transmission (21, 31 & 41 cm Detector)

Personnel
Requirements
4.2 Overview
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, InnovaTM IGS 620, InnovaTM IGS 630, DiscoveryTM IGS
730, DiscoveryTM IGS 740, Optima CL320i/CL323i, Optima IGS 320 and Optima IGS
330.
DiscoveryTM IGS 730, DiscoveryTM IGS 740 systems are also named DiscoveryTM IGS
Systems. The procedure is applicable indifferently to DiscoveryTM IGS 730 or
DiscoveryTM IGS 740.
HHS suitcase with 38 mm 1 system with 21 5245018 -
AL attenuator block and cm detector
lead scatter shield. Note: if
this tool is not available, it is
also possible to use the
suitcase #2408517
designed for system with a
31 cm detector.
AL attenuator block and cm detector
lead scatter shield
with Al attenuator block and cm detector
lead scatter shield and
probe mechanical interface
Standard Service 1 - - -
Engineer's toolkit.
28 4 REG0069 - Primary Barrier Transmission (21, 31 & 41

cm Detector)

The MDH 2025/2026 (or 1 - - -
equivalent) with 6cc probe
for measuring the input
exposure rate 1.0 R/min
(8.76 mGy/min)
Survey meter Victoreen 1 - - -
470A or 451B (or equivalent
in range and accuracy) for
the actual primary barrier
transmission measurement.
4.3.2 Safety
WARNING
X-RAY
The exposure rates due to transmission - -
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 accuracy, 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 Detector - -
4 REG0069 - Primary Barrier Transmission (21, 31 & 41 29

cm Detector)
4.4 Procedure
4.4.1 Gantry Preparation
4.4.1.1 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.
4.4.1.2 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).
2. Move the gantry to the position: L = 0, C = 0, P= –90°C (detector on left lateral side), SID
min.
4.4.1.3 Case system with 21 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 320)
Remove the switch ring (DR1004 of Service Manual DVD), the soft cover, the antenna cover
(DR1103/DR1003) and the grid support (DR1002).
3. Move the gantry to the position: L = 0, C = 0, P = –90°C , SID min.
1. (For Innova and DiscoveryTM 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 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).
1. (For Innova and DiscoveryTM IGS Systems)
Remove the detector covers (DR0245 Service manual DVD), the switch ring and the
collision sensor (DR0255), the left grid slider (DR0254).
4.4.1.6 Case system with 21 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).

cm Detector)

4.4.1.7 Case system with 31 cm detector (biplane)
1. Frontal: Remove the switch ring (DR0326 Innova Service manual DVD), the anticollision
2. Lateral: Remove the soft covers (DR0539 Innova Service manual DVD) the anticollision
4.4.2 Tool Installation
Illustration 12: Test Set-up - C-Arm, Primary Barrier Transmission
4.4.2.1 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 Illustration 12).
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 Illustration 12).
NOTE: A mechanical interface allowing adapting the probe to the attenuator block is
delivered on some systems (systems with 31 & 41 cm detector). This
adaptation fixes per design the distance (10.7 cm) between the probe and the
attenuator block.

cm Detector)
4.4.2.2 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.
Illustration 13: Scatter Lead Shield Positions (View behind the detector)
2. The Illustration 13 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.
4.4.3 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 Illustration 12)
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.

cm Detector)
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 acceptance criteria).
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).
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.
4.4.4 Measurement preparation for Innova 2100-IQ / 3100/3100-IQ / 4100/4100-IQ /
2121-IQ / 3131-IQ, Innova IGS 520, 530, 540, InnovaTM IGS 620, InnovaTM IGS 630,
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 Illustration 12)
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:

cm Detector)
[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.
4.4.5 Measurements
For each scan measurement area illustrated below run the following operations
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 Illustration 13 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 Illustration 13).
NOTE: For Innova 2000 and systems with 21 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 Illustration 13).
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).
4.4.6 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).
4.5 Finalization

cm Detector)
5 REG0070 - Tube Leakage Radiation

Personnel
Requirements
5.2 Overview
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, InnovaTM IGS 620, InnovaTM IGS 630,
and Optima IGS 330.
Victoreen 470 A survey 1 - -
meter
or Victoreen 451B survey 1 - 5270475 -
meter

When the X-Ray tube is operated at its - -
maximum leakage technique factors, the
leakage radiation from the diagnostic
source assembly measured 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.
5 REG0070 - Tube Leakage Radiation 35


On any table where the source is on a - -
moving carriage or the table is capable of
being tilted, the measurement shall be
made with the diagnostic source assembly
at both ends of the table, and with the
table tilted.
On tables with elevating mechanisms, 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-certified 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 Laptop 46–017566 HHS Forms, -
3382 spreadsheet program, or if this is not completing the FDA 2579 and
available, it may be recorded in Form GE data record forms
3382.
5.4 Procedure
NOTE: Use the sketches in F3382 as an aid in recording rough data.
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 5: 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.
36 5 REG0070 - Tube Leakage Radiation

Illustration 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:
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.
Illustration 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.

Illustration 16: Victoreen 451B Survey Meter
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.
Illustration 17:
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.
38 5 REG0070 - Tube Leakage Radiation

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.
5.5 Finalization

6 Fluoro Interlocks
Perform this test as last fluoro test.
6.1 Application
All fluoroscopic imaging assemblies where the primary protective barrier is removable without
tools. At installation and periodic maintenance check.
6.2 Requirement
Interlock shall be provided to prevent X-ray exposure unless the barrier (image intensifier) is in
position to intercept the entire useful beam.
6.3 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.
6.4 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.
40 6 Fluoro Interlocks
78530, Buc
FRANCE
HHS
Collimator Tests
46-017564
Revision 25
HHS Collimator Tests
2
LANGUAGE


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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 72
520, 530, 540
17 September 26, 2011 Update of REG0075 and REG0086 to introduce Discovery 72

IGS 730
18 January 20, 2012 Update of REG0075 and REG0086 to introduce Innova IGS 72
620, 630
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, intro‐ 88
duce 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
Revision History 11
12 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 COLLIMATOR TEST REQUIREMENTS............................................................................... 19

1 Collimator Test Requirements.......................................................................................................19
Chapter 3 COLLIMATOR FUNCTION....................................................................................................21

1 Introduction....................................................................................................................................21
2 REG0071 - Functional Test - Auto Rad Collimator Version.......................................................... 22
3 REG0072 - Functional Test - In-Table Fluoro Collimator Version................................................. 23
4 REG0073 - Functional Test - Vascular Collimator Version........................................................... 24
5 REG0074 - Functional Test - Manual Rad Collimator Version...................................................... 25
Chapter 4 SID TEST.............................................................................................................................. 27

1 REG0075 - SID Test......................................................................................................................27
Chapter 5 LIGHT TO X-RAY FIELD TEST.............................................................................................29

1 REG0076 - Light to X-Ray Field Test............................................................................................29
Chapter 6 CENTER TO CENTER TEST................................................................................................31

1 REG0077 - Center to Center Test for Bucky or Cassette Holder.................................................. 31
2 REG0078 - Center to Center Test for SFD....................................................................................33
3 REG0079 - Center to Center Test for Film Changers................................................................... 36
4 REG0080 - Center to Center Test for Digital Systems.................................................................. 38
Chapter 7 FIELD SIZE INDICATOR (POINTERS TO ACTUAL SIZE) TEST........................................ 41

1 REG0081 - Field Size Indicator Test.............................................................................................41
Chapter 8 SIZE TO SIZE TESTS........................................................................................................... 43

1 REG0082 - Size to Size Test for Bucky or Cassette Holder......................................................... 43
2 REG0083 - Size to Size Test for SFD........................................................................................... 45

3 REG0084 - Size to Size Test for Gantry - Mounted Film Changer................................................48
4 REG0085 - Size to Size Test for Digital Systems..........................................................................50
Chapter 9 FLUORO COLLIMATOR TO IMAGE INTENSIFIER TEST................................................... 55

1 REG0086 - Fluoro Collimator to Image Intensifier Test.................................................................55
1.3.1 Definitions..........................................................................................................................56
1.3.2 Direct Test (non Innova).................................................................................................... 57
1.3.3 Direct Test for Innova........................................................................................................ 58
1.3.4 Indirect Test for Innova / Discovery / Optima.................................................................... 60
1.3.4.1 Goal of the procedure.....................................................................................................60
1.3.4.2 Set geometrical parameters........................................................................................... 61
1.3.4.3 Set X-Ray preliminaries..................................................................................................61
1.3.4.4 Measurements procedure...............................................................................................62
1.3.4.5 Analyze the Test Data Results ...................................................................................... 63
1.3.5 Additional indirect test for Discovery™ IGS systems with Head up display mode............ 63
1.3.5.1 Set geometrical parameters .......................................................................................... 63
1.3.5.2 Set X-Ray preliminaries .................................................................................................65
1.3.5.3 Measurements procedure...............................................................................................65
1.3.5.4 Analyze the Test Data Results ...................................................................................... 67
1.3.6 Mini-Troubleshooting Guide.............................................................................................. 67
1.3.7 Particular case: Collimator gain value limitation................................................................ 68
1.3.8 Formulas for Computation and rejection criteria................................................................68
1.3.8.1 Formulas for Indirect Test for Innova / Discovery / Optima............................................ 68
1.3.8.2 Formulas for Additional indirect test for DiscoveryTM IGS systems with Head up
display mode........................................................................................................... 71
Chapter 10 IMAGE OVERLAP TEST FOR FIXED CONES OR CYLINDERS.......................................77

1 REG0087 - Image Overlap Test for Fixed Cones or Cylinders..................................................... 77
Chapter 11 COLLIMATOR LIGHT FIELD INTENSITY...........................................................................79

1 REG0088 - Collimator Light Field Intensity................................................................................... 79
1.3.1 Requirements.................................................................................................................... 79
1.3.2 Procedure.......................................................................................................................... 80
Chapter 1 Safety
1 Safety
WARNING
EQUIPMENT IN USE.
DEVICES BE USED.
CAUTION
physician.
AMERICAS W–622
P.O. BOX 414
Chapter 1 Safety 17
18 1 Safety
Chapter 2 Collimator Test Requirements

1 Collimator Test Requirements
Use theTable 2-1 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, 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 Coll. to Auto Coll. to Auto Coll. to Man. Coll. to Man. Coll. to Cone/Cyl. to
Bucky or SFD I.I. (Fluoro) Film Changer any Recep. Mobile X–ray any Receptor
Cass. Holder (Note 3)
Examples: XT Suspen‐ RFX/SFX, RFX/SFX, Integral film Table top film, AMX, VMX Tube Stand
sion, Tube Stenoscop Vascular, Re‐ changers such free standing
Stand Remote (Note 6) mote Table, as AFM or L–U film changers
Table (Note 5) Stenoscop
(Note 6)
Test Required
SID X X
Light to X-ray X X X
Center to Cen‐ X X X X (Note 7) X (Note 4)

ter (Note 7)
Field Size Indi‐ X X X (Note 4)

cators
Size to Size X X X
Lamp Bright‐ X X X
ness
Image Overlap X
Fluoro Coll. to X
I.I.
Chapter 2 Collimator Test Requirements 19

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 Chapter 6, REG0078 - Center to Center Test for SFD.
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.
20 1 Collimator Test Requirements

Chapter 3 Collimator Function

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.
Chapter 3 Collimator Function 21

2 REG0071 - Functional Test - Auto Rad Collimator Version

Personnel
Requirements

Requirements are defined in Collimator - -
service manual.
SID scale and/or SID indication 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
2.3 Procedure
1. Check each mode of operation.
2. Verify that collimator enters correct mode when all conditions are met.
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.
2.4 Finalization
22 2 REG0071 - Functional Test - Auto Rad Collimator

Version
3 REG0072 - Functional Test - In-Table Fluoro Collimator Version

Personnel
Requirements

FORMS
3.3 Procedure
1. Check conditions for mode and functions provided by mode as described in Table 3-1.
Table 3-1: Requirements in-table Fluoro Collimator Version
Mode Conditions Required for Mode Function Required for Mode
AUTOMATIC 1. SFD switch in “AUTO” • Shutters limit beam to visual area

in Fluoro.
2. Cassette in place (except Full Digi‐
tal System) • Shutters change automatically to
full size of selected film when cas‐
sette transfers (if applicable).
• Shutters change automatically to

full size of selected record format
during record operation.
• Collimator blades must move to

any new position within 5 seconds.
MANUAL 1. SFD switch in “MANUAL” • Shutters may be controlled man‐

ually, but maximum beam is always
2. Cassette in place (except Full Digi‐ limited to receptor size (Fluoro or
tal System) Record format).
• Maximum field size changes auto‐

matically when cassette transfers
but shutters will not increase open‐
ing, beyond format size.
• Collimator blades must move to

any new position within 5 seconds.
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.
3.4 Finalization

4 REG0073 - Functional Test - Vascular Collimator Version

Personnel
Requirements

X-Ray exposure must not be possible, - -
except at proper SID or SID range.
Collimator blades must move to any new
position in 5 seconds or less.
FORMS
4.3 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.
4.4 Finalization
24 4 REG0073 - Functional Test - Vascular Collimator

Version
5 REG0074 - Functional Test - Manual Rad Collimator Version

Personnel
Requirements

Manual collimators which bear an HHS - -
certification label may be installed in the
systems described in Table 3-2. If in
doubt, contact your supervisor. This Table
also includes any additional system
requirements that apply.
FORMS
5.3 Procedure
1. Verify that radiographic system using manual collimator fits one of the types described in
Table 3-2.
Table 3-2: 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 SID • Means provided to limit beam to cassette size
• Coll. interlocked to prevent operation at other SID's
• Coll. not used with table or wall bucky
Room W/O Permanent Bucky (e.g. table top only) None
Single purpose systems (e.g. HYDRADJUST, UTILEX, None

FRANKLIN HEAD UNIT), ACS 1000

System Description Additional Requirements
Any radiographic system not described above As of 1993 the FDA dropped the positive beam limitation
(PBL) requirement. It 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.
If a collimator and its associated receptor(s) are each capable
of automatic collimation, then auto-collimation must be func‐
tional. However, it is permitted to replace an auto-collimator
with a manual collimator provided there is an on-site opera‐
tor's manual that describes system operation with a manual
collimator.
2. Verify additional requirements noted, if any.

5.4 Finalization
26 5 REG0074 - Functional Test - Manual Rad Collimator

Version
Chapter 4 SID Test

1 REG0075 - SID Test
Personnel
Requirements

The difference between the indicated SID - -
and the actual SID may not exceed 2% of
the indicated SID. Rejection limit is 1.8%.
FORMS
1.3 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.
Illustration 4-1: SID Test, Auto RAD Collimator to Table Bucky
Chapter 4 SID Test 27

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,
InnovaTM IGS 630, DiscoveryTM IGS 730, DiscoveryTM IGS 740, Optima
CL320i/CL323i 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.
1.4 Finalization
28 1 REG0075 - SID Test

Chapter 5 Light to X-Ray Field Test

1 REG0076 - Light to X-Ray Field Test
Personnel
Requirements

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%).
FORMS
This test is normally performed at REG0092 - Light to X-Ray -
tabletop, or at the surface of a wall unit, Field Test of 46–017560, HHS
and so it is most convenient to use the TOOLS
Long Afterglow Phosphor tool, part no.
2120565. However, the test can also be
performed by utilizing 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
alternative procedure.
1.3 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.
Chapter 5 Light to X-Ray Field Test 29

Illustration 5-1: Light to X-Ray Field Test
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.
1.4 Finalization

Chapter 6 Center to Center Test

1 REG0077 - Center to Center Test for Bucky or Cassette Holder
Personnel
Requirements

Misalignment of the center of the X–Ray - -
field and center of the receptor may not
exceed 2% (rejection limit is 1.8%).
FORMS
1.3 Procedure
NOTE: For Remote Tables, refer to REG0078 - Center to Center Test for SFD.
1. The SIDs can be the same as used for the SID test; refer to data record form example
below.
Illustration 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.
Chapter 6 Center to Center Test 31

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.
1.4 Finalization
32 1 REG0077 - Center to Center Test for Bucky or

Cassette Holder
2 REG0078 - Center to Center Test for SFD

Personnel
Requirements
2.2 Overview
Center to Center Test for SFD including Bucky on Remote Tables.
exceed 2%. The rejection limit is 1.8%.
As of June 2, 1993, the FDA dropped the - -
edge to edge requirements in favor of
simpler centering and sizing requirements.
Earlier revisions of Direction 46–013894
dealt with the completion of edge to edge
measurements in terms of peculiar
centering and sizing requirements. The
procedure below is a welcome
simplification.
FORMS
2.4 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.
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
films and complete data entry.
Table 6-1: 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 Metric Data is: X Eng. Metric OK to mix English &
is: metrix
Centering Image size Calc. field size Size errors - % SID
EX SID Table Format data % P/F lat. long. lat. lon lat. long. sum P/F
P g
1 min Hor. 1 on 1 0.3 0.8 p 0.0 0.0
2 min Hor. 2 on 1 long 0.4 1.4 p 0.0 0.0
3 min Hor. 2 on 1 long 0.2 0.7 p 0.0 0.0
4 min Hor. 3 on 1 long 0.3 1.0 p 0.0 0.0
5 min Hor. 3 on 1 long 0.3 1.0 p 0.0 0.0
6 min Hor. 3 on 1 long 0.3 1.0 p 0.0 0.0
7 max Hor. 1 on 1 0.3 0.8 p 0.0 0.0
8 max Vert. 2 ON 1 LONG 0.4 1.0 p 0.0 0.0
9 max Trend 2 ON 1 LONG 0.3 0.8 p 0.0 0.0

.
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).
34 2 REG0078 - Center to Center Test for SFD

Table 6-2: Center to Center for Remote Table
Test data is in: in‐ X cm. OK to use inches w metric cass. etc. error messages
ches
cm. in.
Tube change SID 150.0 59.1 error messages

message appears max
here
SID min 105.0 41.3
Centering
EXP SID Table Format Cassette data % P/F
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 selected 4 max Tren 1 on 1 30 x 24 0.7 0.5 p
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
2.5 Finalization

3 REG0079 - Center to Center Test for Film Changers

Personnel
Requirements
3.2 Overview
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 Chapter 8, REG0084 - Size to Size Test for Gantry -
Mounted Film Changer for sizing tests of integral film changer.
exceed 2%. The rejection limit is 1.8%.
In order to perform a centering test on a - -
film changer, whether it’s free standing or
part of a Gantry mounted system, you
must be able to identify the selected
portion of the film. The selected portion of
the film is defined 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”.
FORMS
3.4 Procedure
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.
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.
36 3 REG0079 - Center to Center Test for Film Changers

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 6-3: Center to Center Test for Gantry Mounted Film Changer
Data entered in: inches x cm. error messages
Enter min. SID: 80.0 cm. max. SID 130.0 cm. (enter digital readout with film changer in posi‐
tion)
tube change message

appears here
Centering
SID data % P/F
min. 0.6 0.8 p p
max. 1.0 0.8 p
3.5 Finalization

4 REG0080 - Center to Center Test for Digital Systems

Personnel
Requirements
4.2 Overview
Center to Center Test for Digital Systems: Chest Unit, Table Bucky or IDD.
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.
available, it may be recorded in form AND GE DATA RECORD
3382. FORMS
4.4 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.
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.
38 4 REG0080 - Center to Center Test for Digital Systems

4.5 Finalization

40 4 REG0080 - Center to Center Test for Digital Systems

Chapter 7 Field Size Indicator (Pointers to Actual Size)

Test
1 REG0081 - Field Size Indicator Test
Personnel
Requirements

The difference between the indicated field - -
size and the actual field size may not
exceed 2% in either direction; 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.
FORMS
1.3 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.
8. Form may direct you to perform additional test at alternate angulation if initial test shows
marginal performance.
Chapter 7 Field Size Indicator (Pointers to Actual Size) 41

Test
Illustration 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.
1.4 Finalization
42 1 REG0081 - Field Size Indicator Test

Chapter 8 Size to Size Tests

1 REG0082 - Size to Size Test for Bucky or Cassette Holder
Personnel
Requirements
1.2 Overview
Size to Size Test for Bucky including Remote Table.
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 directions
combined. Rejection limits are 2.8% and
3.8% respectively.
This procedure uses only one exposure. It Refer to REG0090 - Bucky/ -
has been shown to be at least as Cass. Holder Test (Collimator
accurate, and much faster than older rotation) of 46–017560, HHS
techniques. TOOLS for older technique
with multiple exposures on 1
film.
FORMS
1.4 Procedure
1. Refer to the appropriate test. There are separate tests for standard and remote tables. Refer
to standard table example below.
Chapter 8 Size to Size Tests 43

Illustration 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.
1.5 Finalization
44 1 REG0082 - Size to Size Test for Bucky or Cassette

Holder
2 REG0083 - Size to Size Test for SFD

Personnel
Requirements

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. Per the
FDA, the presence of a mask is irrelevant.
The X-Ray field must 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 provided 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.
FORMS
2.3 Procedure
NOTE: For Remote Tables, refer to REG0082 - Size to Size Test for Bucky or Cassette
Holder.
1. Refer to the data record, Illustration 8-2. Prior to making film tests enter the data for the 5
cells above the chart. If using the hard copy form, you will have to make a magnification film,
calculate magnification, and enter the results in the cells labeled program-calculated mag.
factors.

Illustration 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
46 2 REG0083 - Size to Size Test for SFD

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.
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.
2.4 Finalization

3 REG0084 - Size to Size Test for Gantry - Mounted Film Changer

Personnel
Requirements

The difference between the X–Ray 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 defined - -
by the film changer input plane opening.
You may need to remove covers and grids
to expose the opening.
FORMS
3.3 Procedure
1. Refer to the example below (Illustration 8-3 and Illustration 8-4).
Illustration 8-3: Size to Size Test for Gantry-Mounted Film Changer - Center to Center
Instructions
NOTE: Refer to Chapter 6, REG0079 - Center to Center Test for Film Changers.
48 3 REG0084 - Size to Size Test for Gantry - Mounted

Film Changer
Illustration 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. RepeatStep 7 at the maximum SID.
3.4 Finalization

4 REG0085 - Size to Size Test for Digital Systems

Personnel
Requirements
4.2 Overview
Size to Size Test for Digital Systems: Chest Unit, Table Bucky or IDD.
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 collimators.
available, it may be recorded in form AND GE DATA RECORD
3382. FORMS
4.4 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.
50 4 REG0085 - Size to Size Test for Digital Systems

Illustration 8-5: Example Chest Unit
NOTE: Refer to REG0082 - Size to Size Test for Bucky or Cassette Holder.
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.
4. Make an exposure at 60 kVp in each of the three selected formats.
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.
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.
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 fromStep 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. RepeatStep 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.
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.
15. If all of the images fromStep 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 Illustration 8-6. 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 ofStep 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.

Illustration 8-6: Example Collimator Blades
NOTE: Refer to REG0082 - Size to Size Test for Bucky or Cassette Holder.
4.5 Finalization


Chapter 9 Fluoro Collimator to Image Intensifier Test

1 REG0086 - Fluoro Collimator to Image Intensifier Test
Personnel
Requirements

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 directions, 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,
Innova 4100/4100-IQ, Innova IGS 520,
530, 540, Innova 2100-IQ (Optima
Edition), Innova 3100-IQ (Optima Edition),
Innova 2121-IQ, 3131-IQ, InnovaTM IGS
620, InnovaTM IGS 630, DiscoveryTM IGS
730, DiscoveryTM IGS 740, Optima
CL320i/CL323i, Optima IGS 320 and
Optima IGS 330 depending of the P011 -
Collimator Gain calibration content (see
below Procedure section) either the 4
blades shall be visible in all the angulation
(and direct test is required) or one vertical
and one horizontal collimator blade shall
be visible (and indirect test shall be
executed).
NOTE: DiscoveryTM IGS 730, DiscoveryTM - -
IGS 740 systems are also named
DiscoveryTM IGS Systems. The procedure
is applicable indifferently to DiscoveryTM
IGS 730 or DiscoveryTM IGS 740.
Chapter 9 Fluoro Collimator to Image Intensifier Test 55


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.
1.3 Procedure
1.3.1 Definitions
Collimator blades (rectangular and corner): For Head up display mode (DiscoveryTM IGS
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), 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 DiscoveryTM IGS systems.
Image reception area: Surface on which an X-ray pattern is received (in our case: the detector
entrance plane).
mage rotation angleI: 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).
56 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 Illustration 9-5.
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.
1.3.2 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.

Illustration 9-1:
1.3.3 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
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.

Illustration 9-2:
2. Otherwise, for Innova 3131-IQ, Innova 2121-IQ and InnovaTM IGS 620, InnovaTM IGS 630
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, DiscoveryTM IGS 730, DiscoveryTM IGS 740, Optima CL320i/CL323i, 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 least one horizontal
and one vertical rectangular collimator blade visible”, the indirect test described in next
section must be made to measure misalignment.

Illustration 9-3:
1.3.4 Indirect Test for Innova / Discovery / Optima
NOTICE
(For DiscoveryTM IGS systems)
For Discovery™ IGS systems with Head up display mode, the whole compliance
verification process is divided in two consecutive procedures. First execute
“Indirect Test for Innova / Discovery / Optima” which checks compliance for
square X-ray field, then, execute “Additional indirect test for Discovery™ IGS
systems with Head up display mode”, which verifies the compliance for octagonal
X-ray field.
For Discovery™ IGS systems without Head up display mode, only execute
“Indirect Test for Innova / Discovery / Optima”.
1.3.4.1 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).
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.
1.3.4.2 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 Section 1.3.8 for typical SID values).
1.3.4.3 Set X-Ray preliminaries
1. If applicable, de-activate Head up display mode (rotation button is not highlighted). Head up
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:
Illustration 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).
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.
1.3.4.4 Measurements procedure
1. Measure Monitor image width (refer to Illustration 9-11) 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.
Illustration 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.

Illustration 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
1.3.4.5 Analyze the Test Data Results
Verify the measured data points are all recorded and formulas specified in “Formulas for Indirect
Test for Innova / Discovery / 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 Section 1.3.6.
3. For DiscoveryTM IGS systems with Head up display mode, if no fail, perform “Additional
indirect test for DiscoveryTM IGS 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.
1.3.5 Additional indirect test for Discovery™ IGS systems with Head up display mode
This part is only applicable for Discovery™ IGS 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 DiscoveryTM IGS systems with Head up display mode”.
1.3.5.1 Set geometrical parameters

Set the geometrical parameters as indicated below:
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.
Illustration 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.
Illustration 9-8: Example of setup (diagram is not on scale)

(For Discovery IGS 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 730 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°.
NOTE:
NB: swivel angle is equal to the image rotation angle (θ):
1.3.5.2 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. Record the new collimator gain (Cgn’) in Data Results report.
1.3.5.3 Measurements procedure
If you don’t have the Test Data Result file, use instruction found in “Formulas for Additional
indirect test for DiscoveryTM IGS 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.

Illustration 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.
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 Illustration 10 below.

Illustration 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.
1.3.5.4 Analyze the Test Data Results
Verify the measured data points are all recorded and formulas specified in “Formulas for
Additional indirect test for DiscoveryTM IGS 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 Section 1.3.6.
1.3.6 Mini-Troubleshooting Guide
1. Use the table below to identify the problem.
In case of fail in” Indirect Test for Innova / Discovery / Optima”, check Table 1.
Table 9-1: Troubleshooting guide: compliance of square X-ray field
Problem No. Possible cause Recommended action
Result of “Actual versus 1 Blade not visible or too visible Do “P011 Calibration”
displayed FOV” failed on the monitor
Results of “Discrepan‐ 2 Alignment of the detector Do Alignment and SID (refer to

cies of X-Field versus “RG09 Detector Alignment” of
Image reception area” Power On Installation in SM CD/
failed DVD).
If after an alignment redo the
test still fails execute Section
1.3.7.
In case of fail in “Additional indirect test for DiscoveryTM IGS systems with Head up
display mode”, check Table 2.

Table 9-2: Troubleshooting guide: compliance of octagonal X-ray field
Problem No. Possible cause Recommended action
Result of “Actual versus 1 Blade not visible or too visible If blades are not visible: Lower
displayed FOV” failed on the monitor collimator gain value:
(Gain_new = Gain_old – 1); en‐
ter new collimator gain in excel
sheet and check other test ID.
If blades are too visible: In‐
crease collimator gain value:
(Gain_new = Gain_old + 1); en‐
ter new collimator gain in excel
sheet and check other test ID.
Results of “Discrepan‐ 2 Alignment of the detector or col‐ Do Alignment and SID (refer to
cies of X-Field versus limator fail “RG09 Detector Alignment” of
Image reception area” Power On Installation in SM CD/
or “Percentage of over‐ DVD).
lap” or “Maximum ex‐ If after an alignment redo the
tent” failed test still fails check the results of
corner blade decentering. If it is
also failed, there might be a
problem with the collimator. Re‐
place collimator.
2. Carry out the necessary steps to correct the error. If problem persists, contact Service
Support.
1.3.7 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.
1.3.8 Formulas for Computation and rejection criteria
1.3.8.1 Formulas for Indirect Test for Innova / Discovery / 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).

Illustration 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 Illustration 9-5
and Illustration 9-6.
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:
Illustration 9-12:
Where:
INNOVA / INNOVA / INNOVA DISCOVERY DISCOVERY
OPTIMA IGS 320 OPTIMA CL320i/
CL323i / OPTIMA IGS
330
Detector 20 cm Detector 30 cm Detector 40 cm Detector 30 cm Detector 40 cm
A = max FOV 20 30 40 30 40
B = primary barrier 228 335.5 433 335.5 433

size (mm)
C = primary barrier 27 12 11.5 12 11.5

behind detector
plane distance
(mm)
D = primary barrier 1.25 1.25 1.25 1.25 1.25

6 sigma de-center‐
ing (mm)
E = SID min (cm) 85 89 95 99 99
F = Max misalign‐ Computed in pro‐ Computed in procedure Computed in pro‐ Computed in pro‐ Computed proce‐
ment in Max FOV cedure cedure cedure dure
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.

1.3.8.2 Formulas for Additional indirect test for DiscoveryTM IGS systems with Head up display
mode
This part is only applicable for Discovery™ IGS systems with Head up display mode.
It verifies the compliance of octagonal X-ray field.
The computations are divided in two parts:
• Decentering of corner blades
• Compliance of octagonal X-ray field
1. Decentering of corner blades

a. From “Formulas for Indirect Test for Innova / Discovery / 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 Illustration 9-9 is displayed on the monitor.
h. Measure discrepancies for octagonal X-ray field:
Make measurements c1’, c2’, d1’ and d2’ in cm on monitor. Refer to
Illustration 9-9.

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

j. Press Fluoro switch. A figure similar to Illustration 9-10 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 Illustration
9-10.
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.
Illustration 9-13:
Illustration 9-14:
m. Compute dx’ and dy’ which are the coordinates of corner collimator blades center in
diagonal directions of the square X-ray field.
Illustration 9-15:
Illustration 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.
Illustration 9-17:

Illustration 9-18:
o. 16. 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 / 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.
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.
Illustration 9-19:

Illustration 9-20:
d. Compute center coordinates of corner blades in A1 system.
Illustration 9-21:
Illustration 9-22:
e. Compute center coordinates of corner blades in A2 system.
Illustration 9-23:
Illustration 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:
Illustration 9-25:
Illustration 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):
Illustration 9-27:
Illustration 9-28:
iii. Compute discrepancies c1r’, c2r’, d1r’ and d2r’ for all FOVs and all SIDs:
Illustration 9-29:
Illustration 9-30:
Illustration 9-31:
Illustration 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:

• abs(FOV’ length – FOV) < 1% SID
• abs(FOV’ width – FOV) < 1% SID
If any test is failed refer to Section 1.3.6.

1.4 Finalization

Chapter 10 Image Overlap Test for Fixed Cones or

Cylinders
1 REG0087 - Image Overlap Test for Fixed Cones or Cylinders
Personnel
Requirements
1.2 Overview
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.
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 dimensions
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 possibility.
1.4 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.
Chapter 10 Image Overlap Test for Fixed Cones or 77

Cylinders
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.
9. Measure the overall image size on the small film and enter data onto form.
Illustration 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.
1.5 Finalization
78 1 REG0087 - Image Overlap Test for Fixed Cones or

Cylinders
Chapter 11 Collimator Light Field Intensity

1 REG0088 - Collimator Light Field Intensity
Personnel
Requirements

Approved Light meter must 1 - - -
have an accuracy of 5% or
better.
Fluke Digital Multimeter on 1 - - -
the 200V scale or
equivalent.
1.3 Procedure
1.3.1 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 11-1. 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 11-1: 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
Chapter 11 Collimator Light Field Intensity 79

Minimum Reading (Lamp Voltage)
Siemens collimator: 22.2 VAC + meter tolerance
Eclipse Proteus Collimator 13.4 VDC + meter tolerance
Table 11-2: Mini-Troubleshooting Guide
Low output Lamp, Mirror, Mylar window dirty or discolored.
Lamp voltage low. Refer to Table 11-1.
Mirror in backwards.
Supply cable too long.
Faulty collimator bulb.
Faulty lamp socket.
1.3.2 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).
80 1 REG0088 - Collimator Light Field Intensity

Illustration 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
If a light meter is not available, set the lamp base voltage to read at least the voltage
called for in Table 11-1. 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.
1.4 Finalization
Chapter 11 Collimator Light Field Intensity 81

82 1 REG0088 - Collimator Light Field Intensity

78530, Buc
FRANCE
GE Healthcare
HHS
Mammography Tests
46-017565
Revision 3
HHS Mammography Tests
2
LANGUAGE
Revision History
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

Required Persons Preliminary Reqs Procedure Finalization

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


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. - -
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).

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

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 - -
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.


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).
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


3.2 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

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:

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

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

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System Field Test for HHS

• Не използвайте оборудването, преди да сте се консултирали и разбрали

• Неспазването на това предупреждение може да доведе до нараняване на

UPOZORENJE Ovaj servisni priručnik dostupan je na engleskom jeziku.

VÝSTRAHA Tento provozní návod existuje pouze v anglickém jazyce.

• V případě nedodržování této výstrahy může dojít k poranění pracovníka prodejního

ADVARSEL Denne servicemanual findes kun på engelsk.

• Forsøg ikke at servicere udstyret uden at læse og forstå denne servicemanual.

• Manglende overholdelse af denne advarsel kan medføre skade på grund af elektrisk

WAARSCHUWING Deze onderhoudshandleiding is enkel in het Engels verkrijgbaar.

• Probeer de apparatuur niet te onderhouden alvorens deze onderhoudshandleiding

• Indien deze waarschuwing niet wordt opgevolgd, zou het onderhoudspersoneel, de

WARNING This service manual is available in English only.

HOIATUS See teenindusjuhend on saadaval ainult inglise keeles.

• Ärge üritage seadmeid teenindada enne eelnevalt käesoleva teenindusjuhendiga

• Käesoleva hoiatuse eiramine võib põhjustada teenuseosutaja, operaatori või pat‐

VAROITUS Tämä huolto-ohje on saatavilla vain englanniksi.

• Mikäli tätä varoitusta ei noudateta, seurauksena voi olla huoltohenkilöstön, laitteis‐

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

• Le non-respect de cet avertissement peut entraîner chez le technicien, l'opérateur

WARNUNG Diese Serviceanleitung existiert nur in englischer Sprache.

• Wird diese Warnung nicht beachtet, so kann es zu Verletzungen des Kundendienst‐

ΠΡΟΕΙΔΟΠΟΙΗΣΗ Το παρόν εγχειρίδιο σέρβις διατίθεται μόνο στα αγγλικά.

• Αν δεν προσέξετε την προειδοποίηση αυτή, ενδέχεται να προκληθεί τραυματισμός

FIGYELMEZTETÉS Ezen karbantartási kézikönyv kizárólag angol nyelven érhető el.

• Ne próbálja elkezdeni használni a berendezést, amíg a karbantartási kézikönyvben

• Ezen figyelmeztetés figyelmen kívül hagyása a szolgáltató, működtető vagy a beteg

AÐVÖRUN Þessi þjónustuhandbók er aðeins fáanleg á ensku.

AVVERTENZA Il presente manuale di manutenzione è disponibile soltanto in lingua inglese.

• Procedere alla manutenzione dell'apparecchiatura solo dopo aver consultato il pre‐

경고 본 서비스 매뉴얼은 영어로만 이용하실 수 있습니다.

• 본 서비스 매뉴얼을 참조하여 숙지하지 않은 이상 해당 장비를 수리하려고 시도하지

• 본 경고 사항에 유의하지 않으면 전기 쇼크, 기계적 위험, 또는 기타 위험으로 인해 서

BRĪDINĀJUMS Šī apkopes rokasgrāmata ir pieejama tikai angļu valodā.

• Neveiciet aprīkojuma apkopi bez apkopes rokasgrāmatas izlasīšanas un sapraša‐

• Šī brīdinājuma neievērošanas rezultātā var rasties elektriskās strāvas trieciena, me‐

ĮSPĖJIMAS Šis eksploatavimo vadovas yra tik anglų kalba.

• Nemėginkite atlikti įrangos techninės priežiūros, jei neperskaitėte ar nesupratote šio

ADVARSEL Denne servicehåndboken finnes bare på engelsk.

• Ikke forsøk å reparere utstyret uten at denne servicehåndboken er lest og forstått.

OSTRZEŻENIE Niniejszy podręcznik serwisowy dostępny jest jedynie w języku angielskim.

• Nie próbować serwisować urządzenia bez zapoznania się z niniejszym podręczni‐

• Niezastosowanie się do tego ostrzeżenia może doprowadzić do obrażeń serwisan‐

ATENÇÃO Este manual de assistência técnica encontra-se disponível unicamente em inglês.

• A não observância deste aviso pode ocasionar ferimentos no técnico, operador ou

ATENÇÃO Este manual de assistência técnica só se encontra disponível em inglês.

• O não cumprimento deste aviso pode colocar em perigo a segurança do técnico, do

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

• Nu încercaţi să reparaţi echipamentul decât ulterior consultării şi înţelegerii acestui

• Ignorarea acestui avertisment ar putea duce la rănirea depanatorului, operatorului

ОСТОРОЖНО! Данное руководство по техническому обслуживанию представлено только на

• Перед техническим обслуживанием оборудования обязательно обратитесь к

• Несоблюдение требований данного предупреждения может привести к тому,

UPOZORENJE Ovo servisno uputstvo je dostupno samo na engleskom jeziku.

• Zanemarivanje ovog upozorenja može dovesti do povređivanja servisera, rukovaoca

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

• Nepokúšajte sa o obsluhu zariadenia, kým si neprečítate návod na obluhu a nepor‐