Ralco R302/A User manual

Date of Issue:
11.02.2011
Revision Level:
CIssued by:
Ralco s.r.l.
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Ralco s.r.l.
R302/A
COLLIMATORE RADIOLOGICO MANUALE
MANUAL X-RAY COLLIMATOR
MTR302/A- R302F/A - R302L/A DHHS

.
Livello Revisione/Revision Level:
R 302/a Versione standard.
Standard version.
R 302/A DHHS
Versione certificata FDA
disponibile su richiesta
FDA certified version
available on request.
R 302F/A Versione standard.
R 302F/a DHHS
Versione certificata FDA
disponibile su richiesta
FDA certified version
available on request.
R 302L/A Versione standard
R 302L/A DHHS
Versione certificata FDA
disponibile su richiesta
FDA certified version
available on request.
The English version of this manual is a translation of the Italian text, which prevails in
case of doubts.
Rev. N Data/Date N Descrizone/Description
A 22.03.2010 MRD/003/10 Nuova direttiva 2007/47/CE
New directive 2007/47/CE
B 21.04.2011 MRD/005/11 Sostituzione etichette FDA
FDA Label replacement
C 14.07.2011
26.09.2011
24.10.2011
MRD/013/11
MRM/251/11
MRD/018/11
Etichetta collimatore, Manuali di istruzioni
Parti di ricambio aggiornamento
Revisione a tabella IEC 60601-1-2:207
Collimator label, Instruction manual
Spare parts revision
Revision to table IEC 601-1-2:2007

MTR302/A - R302F/A - R302L/A DHHS 1
MTR302/A - R302F/A - R302L/A DHHS - Contents
CONTENTS
FRONT MATTER
DESCRIPTION
OPTIONAL ITEMS.............................................3
Validation of Specification Data ....................4
EN 60825-1 par.1 -5 .....................................4
EN 60601-1 par. 5 ........................................5
Operation Environment.................................5
Storage .........................................................5
EN 60601-1-3 para. 29.205 - Focus-Skin
Distance........................................................5
29.205.1 - Radiation Equipment for
Fluoroscopy ..................................................5
TUBE COMPATIBILITY
INSTALLATION
MOUNTING THE COLLIMATOR TO THE X-RAY
TUBE..............................................................1
ELECTRICAL CONNECTION
Power Supply Connection ............................1
R302/A .........................................................2
SCHEDA GC-LED-5A ......................................4
Connectors ...................................................4
Jumpers ........................................................4
Trimmers.......................................................5
CALIBRATION
CENTERING, X-RAY BEAM ...............................1
Collimator to Focal Spot Alignment
(Primary Shutter Cut-Off)..............................2
LIGHT FIELD TO X-RAY FIELD ALIGNMENT ........2
LIGHT FIELD CALIBRATION...............................2
Longitudinal Alignment (Long) ......................2
VERTICAL ALIGNMENT .....................................3
Transversal Calibration (CROSS).................3
ACCESS TO COLLIMATOR COMPONENTS ..........4
ADJUSTMENTS
FIELD SIZE INDICATION ADJUSTMENT...............1
Shutter Dial Adjustment ................................1
BUCKY LIGHT LINE ADJUSTMENT .....................1
Bucky Position Adjustment ...........................1
CROSSHAIR ADJUSTMENT ...............................1
Friction Brake Adjustment.............................1
MECHANICAL MOTION STOP ADJUSTMENT .......2
CLOSED Stop Long and Cross Shutters......3
Closed Stop ................................................3
LASER LIGHT/IMAGE RECEPTOR ALIGNMENT....3
Adjustment Procedures ................................4
COMPLIANCE VERIFICATION
MINIMUM FILTRATION REQUIREMENT ...............1
Visual Determination of Half-Value
Layer (hvl).....................................................2
Quick-Check of Minimum Filtration
Requirement at a Particular kvp ...................2
Standard Absorber Method...........................2
VISUAL DEFINITION OF X-RAY VERSUS LIGHT
FIELD .............................................................3
FIELD SIZE INDICATION ...................................3
CROSSHAIR ALIGNMENT..................................3
LIGHT FIELD ILLUMINATION INTENSITY..............3
SYMBOLS .......................................................5
EMC COMPLIANCE .........................................7
Electromagnetic Emissions ..........................7
Electromagnetic Immunity for All Equipment
and Systems.................................................8
Electromagnetic Immunity for Non
Life-Supporting System ................................9
Recommended Separation Distances for
Non-Life Supporting Equipment .................11
OPERATION INSTRUCTIONS
LIGHT/X-RAY FIELD SETTING...........................1
Front Panel ...................................................1
TROUBLESHOOTING
SUBSTITUTIONS
Substitution of the Led..................................1
Substitution of the Electronic Board for Power
Led................................................................1
Substitution of the Laser...............................1
SUBSTITUTION OF THE MIRROR .......................2
SPARE PARTS
R302/A - R302/A DHHS ...............................1
R 302F/A - R302F/A DHHS..........................1
R302L/A - R302L/A DHHS ...........................2
Parts Breakdown ..........................................6
R302/A - R302/A DHHS ...............................6
R302F/A- R302F/A DHHS............................7
R302L/A - R302L/A DHHS ...........................8
MAINTENANCE
CLEANING RECOMMENDATIONS .......................1
DISINFECTION.................................................1
RECOMMENDED MAINTENANCE PROGRAMME...1
GENERAL
REPAIRS ........................................................1
END OF LIFE DISPOSAL...................................1
WARRANTY ....................................................1
COMPONENTS NOT COVERED BY THIS
WARRANTY ....................................................2
DISASSEMBLY.................................................2
TRANSPORT AND STORAGE.............................2
SAFETY/RESPONSIBILITY.................................3
RESIDUAL RISKS.............................................3
PERSONALIZATIONS

MTR302/A - R302F/A - R302L/A DHHS
Contents
2

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
Front Matter
1
R302/A - Front Matter
Ralco srl
FRONT MATTER
ILPRESENTE MANUALE D’ISTRUZIONI DEVE
ESSERE LETTO ECOMPRESO NEL SUO
COMPLESSO DA L’INSTALLATORE E
L’OPERATORE.
THE FOLLOWING INSTRUCTION MANUAL MUST
BE READ AND UNDERSTOOD IN ITS ENTIRETY
BY THE INSTALLER AND OPERATOR.
ILCOLLIMATORE ÈDESTINATO AD ESSERE
COLLEGATO AD UNA MACCHINA RADIOLOGICA
CHE PRODUCE RADIAZIONI IONIZZANTI PER USO
MEDICO OVETERNINARIO.
CHIUNQUE SIA AUTORIZZATO AD INTERVENIRE
SULL’APPARECCHIATURA RADIOLOGICA DEVE
ESSERE PIENAMENTE ACONOSCENZA DELLE
PROCEDURE RIGUARDANTI LA PROTEZIONE
CONTRO LE RADIAZIONI, DELL’UTILIZZO
DELL’APPARECCHIATURA EDELLA
MANUTENZIONE DI ESSA.
RALCO NON ÈRESPONSABILE DI EVENTUALI
DANNI ACOSE E/OAPERSONE DERIVANTI
DALL’UTILIZZO IMPROPRIO E/OSCORRETTO DEL
COLLIMATORE.
QUESTO MANUALE DEVE ESSERE DISPONIBILE
PER L’INSTALLATORE EL’OPERATORE.
INTENDED USE OF THE COLLIMATOR
THIS COLLIMATOR IS DESIGNED TO BE USED
WITH ARADIOLOGICAL SYSTEM PRODUCING
IONIZING RADIATION FOR MEDICAL OR
VETERINARY USE.
WHOEVER IS AUTHORIZED TO OPERATE OR
SERVICE THE RADIOLOGICAL EQUIPMENT MUST
BE THOROUGHLY FAMILIAR WITH THE
PROCEDURES RELATED TO RADIATION
PROTECTION AND EQUIPMENT USE AND
MAINTENANCE.
RALCO IS NOT RESPONSIBLE FOR ANY
PERSONAL INJURIES OR DAMAGE TO PROPERTY
FROM MISUSE OR UNINTENDED USE OF THE
COLLIMATOR.
THIS MANUAL MUST BE MADE AVAILABLE TO
THE INSTALLER AND OPERATOR.
RESPONSABILITÀ DELL’ INSTALLATORE E
DELL’OPERATORE
L’INSTALLATORE EL’OPERATORE, DOPO
L’INSTALLAZIONE EPRIMA DI OGNI UTILIZZO,
DEVONO VERIFICARE CHE TUTTE LE NORMATIVE
RIGUARDANTI LA SICUREZZA SIANO STATE
APPLICATE. TUTTE LE PROCEDURE
RIGUARDANTI L’INSTALLAZIONE EL’UTILIZZO
SICURO DEL COLLIMATORE DEVONO ESSERE
SCRUPOLOSAMENTE OSSERVATE.
INSTALLER AND OPERATOR RESPONSIBILITY
THE INSTALLER AND OPERATOR MUST VERIFY
THAT ALL SAFETY STANDARDS ARE FOLLOWED
IMMEDIATELY AFTER INSTALLATION OF THE
COLLIMATOR AND BEFORE ANY SUBSEQUENT
USE.
ALL PROCEDURES REGARDING THE
INSTALLATION AND SAFE USE OF THIS
COLLIMATOR MUST BE STRICTLY FOLLOWED.
SEGNALAZIONI
LEINFORMAZIONI RIGUARDANTI EVENTUALI
INCIDENTI VERIFICATISI DURANTE L'UTILIZZO
DEL COLLIMATORE RADIOLOGICO VANNO
COMUNICATE IMMEDIATAMENTE ALLA RALCO
S.R.L.
REPORTING
INFORMATION REGARDING ACCIDENTS THAT
HAVE OCCURRED WHILE USING THE
COLLIMATOR MUST BE REPORTED IMMEDIATELY
TO RALCO, SRL.

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
Front Matter
2
R302/A - Front Matter
Ralco srl
RESPONSABILITÀ LIMITATA
RALCO DECLINA OGNI RESPONSABILITÀ
QUALORA NON VENGANO RISPETTATE LE
INDICAZIONI DEL PRESENTE MANUALE TECNICO.
INOLTRE, LA RESPONSABILITÀ RALCO DECADE
NEI SEGUENTI CASI:
•IL COLLIMATORE RADIOLOGICO ÈDI COSTRUZIONE
RALCO MA SU CONTRATTO CLIENTE;
•IL COLLIMATORE RADIOLOGICO ÈSTATO MODIFICATO
DALL'INSTALLATORE E/OUTILIZZATORE;
•IL COLLIMATORE RADIOLOGICO ÈSTATO INSTALLATO
NON RISPETTANDO LE INDICAZIONI DEL PRESENTE
MANUALE;
•I
LCOLLIMATORE ÈSTATO UTLIZZATO PER SCOPI NON
CONSONI;
•IL COLLIMATORE ÈSTATO INSTALLATO DA PERSONALE
NON COMPETENTE;
•IL COLLIMATORE ÈSTATO UTILIZZATO NON
RISPETTANDO LE INDICAZIONI DI SICUREZZA E
CONTRARIAMENTE AQUANTO INDICATO NEL
PRESENTE MANUALE;
•IL COLLIMATORE NON ÈSTATO SOTTOPOSTO ALLE
VERIFICHE FUNZIONALI EALLA MANUTENZIONE DI
ROUTINE DA PERSONALE COMPETENTE;
•IL COLLIMATORE ÈSTATO RIPARATO CON PARTI DI
RICAMBIO NON ORGINALI;
LIMITATION OF LIABILITY
RALCO IS NOT LIABLE IF THE PROVIDED
INSTRUCTIONS ARE NOT COMPLIED WITH.
FURTHERMORE, RALCO IS NOT LIABLE IF ONE
OR SEVERAL OF THE FOLLOWING INSTANCES
APPLY:
•IFTHE UNIT IS SPECIFICALLY DESIGNED PER CLIENT
SPECIFICATIONS AND THE CERTIFICATION WAS THE
DUTY OF THE CLIENT;
•THE COLLIMATOR WAS MODIFIED IN ANY WAY BY THE
OEM OR OPERATOR;
•T
HE COLLIMATOR WAS INSTALLED WITHOUT
RESPECTING THE INSTRUCTIONS, AS PROVIDED IN
THIS MANUAL;
•T
HE COLLIMATOR WAS USED IN AWAY OUTSIDE ITS
INTENDED USE;
•T
HE COLLIMATOR WAS NOT INSTALLED BY
COMPETENT PERSONNEL;
•T
HE COLLIMATOR WAS NOT OPERATED SAFELY OR IN
AWAY CONTRARY TO THE INSTRUCTIONS IN THIS
MANUAL;
•THE COLLIMATOR WAS NOT SUBJECT TO ROUTINE
INSPECTION AND MAINTENANCE BY COMPETENT
PERSONNEL;
•THE COLLIMATOR WAS REPAIRED WITH NON-RALCO
SPARE PARTS;
ALTRI UTILIZZI NON RAGIONEVOLMENTE
PREVISTI DALLA RALCO
RALCO DECLINA OGNI RESPONSABILITÀ,
DIRETTA OINDIRETTA, PER EVENTUALI DANNI
ACOSE OPERSONE DERIVANTI DALLA MANCATA
OSSERVANZA DELLE PROCEDURE DI QUESTO
MANUALE.
ANY OTHER USES NOT REASONABLY
FORESEEN BY RALCO.
RALCO IS NOT LIABLE FOR ANY, DIRECT OR
INDIRECT, DAMAGE CAUSED IF THE
PROCEDURES IN THIS MANUAL ARE NOT
FOLLOWED.
DICHIARAZZIONE CONFORMITÀ ATUTTE LE
NORME APPLICABILI DURANTE LA PRODUZIONE
DEL COLLIMATORE.
RALCO PRODUCE TUTTI ICOLLIMATORI IN
CONFORMITÀ ATUTTE LE NORME ELETTRICHE
EQUELLE DI SICUREZZA. OGNI COLLIMATORE
ÈCOMPLETAMENTE TESTATO, DOCUMENTANDO
RELATIVI RISULTATI. TALI RISULTATI E
PROCEDURE SONO DISPONIBILI SU RICHIESTA.
TUTTI ICOLLIMATORI VENGONO FORNITI IN
CONFORMITÀ ATUTTE LE NORME MENZIONATE
IN QUESTO MANUALE.
STATEMENT OF STRICT COMPLIANCE TO ALL
APPLICABLE NORMS DURING COLLIMATOR
PRODUCTION
RALCO PRODUCES ALL COLLIMATORS
PURSUANT TO ALL APPLICABLE HEALTH,SAFETY
AND ELECTRICAL STANDARDS. EACH
COLLIMATOR IS THOROUGHLY TESTED WITH
RESULTS DOCUMENTED. THESE RESULTS AND
PROCEDURES ARE AVAILABLE AT REQUEST.
ALL COLLIMATORS LEAVE THE RALCO FACILITY
IN COMPLIANCE TO ALL THE NORMS MENTIONED
IN THIS MANUAL.

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
Front Matter
3
R302/A - Front Matter
Ralco srl
ILCOLLIMATORE IN OGGETTO, UTILIZZATO SU
APPARECCHIATURE RADIOLOGICHE, È
CLASSIFICATO TIPO IIB SECONDO L’ALLEGATO
IX. IL COLLIMATORE ÈSTATO PROGETTATO
EREALIZZATO IN MODO CONFORME ALLE
PRESCRIZIONI DELL’ALLEGATO II DEL DECRETO
LEGISLATIVO 24 FEBBRAIO1994, N.46,
ATTUAZIONE DELLA DIRETTIVA 93/42/CEE DEL
14 GIUGNO 1993 ESUCCESSIVE MODIFICHE
INTERCORSE APPLICANDO LA DIRETTIVA 2007/
47/CE.
NORME STANDARD APPLICATE:
EN 60601-1:2006-10
EN 60601-1-2:2001+A1:2006
EN 60601-1-3:2008-04
EN 60825-1:1994+A1:2002+A2:2001
ISO 9001:2008
UNI ESO 13485:2004
21 CFR SUBCHAPTER J (FDA)
8750 01 & 8750 81 (CSA)
CE
*RALCO PUÒ FORNIRE LA DOCUMENTAZIONE
RIGUARDANTE LA CONFORMITÀ ALLE NORME
SOPRA ELENCATE.
THE COLLIMATOR DESCRIBED HERE, IS USED
ON RADIOLOGICAL SYSTEMS AND IS CLASSIFIED
AS ATYPE IIB ACCORDING TO ATTACHMENT
IX. THE COLLIMATOR HAS BEEN DESIGNED
AND MANUFACTURED IN COMPLIANCE TO
ATTACHMENT II OF LEGISLATIVE DECREE, 2
FEBRUARY 1997, N. 46, IMPLEMENTATION OF
DIRECTIVE 93/42/CEE OF 14 JUNE 1993 AND
SUCCESSIVE MODIFICATIONS APPLYING
DIRECTIVE 2007/47/CE.
LIST APPLICABLE STANDARDS AND TO WHICH
RALCO ADHERES TO:
EN 60601-1:2006-10
EN 60601-1-2:2001+A1:2006
EN 60601-1-3:2008-04
EN 60825-1:1994+A1:2002+A2:2001
ISO 9001:2008
UNI ESO 13485:2004
21 CFR SUBCHAPTER J (FDA)
8750 01 & 8750 81 (CSA)
CE
*RALCO CAN PROVIDE DOCUMENTATION
REGARDING ITS ADHERENCE TO ANY OF THE
ABOVE STANDARDS.
RISCHI RESIDUI
ILCOLLIMATORE ÈCOSTRUITO RISPETTANDO
LE NORME VIGENTI PER RISPONDERE AI
REQUISITI DELLA DIRETTIVA 2007/47/CE E
TUTTE LE ALTRE NORME APPLICABILI. TUTTAVIA,
DATA L’INERENTE PERICOLOSITÀ DELLA
RADIOLOGIA CONTRO LA QUALE ÈIMPOSSIBILE
TUTELARSI TOTALMENTE, ÈINDISPENSABILE
CHE TUTTE LE PROCEDURE DI SICUREZZA SIANO
SEGUITE. L’INSTALLATORE EL’OPERATORE
DEVONO SEGUIRE TUTTE LE PROCEDURE
DEFINITE (INCLUSE QUELLE DESCRITTE NEL
PRESENTE MANUALE) PER RIDURRE IL RISCHIO
RESIDUO DEI RAGGI-X.
INHERENT DANGER OF X-RAYS
THE COLLIMATOR HAS BEEN CONSTRUCTED
TO CURRENT STANDARDS TO MEET THE SAFETY
REQUISITES OF DIRECTIVE 2007/47/CE AND
ALL OTHER APPLICABLE STANDARDS.
HOWEVER, DUE TO RADIOLOGY BEING AN
INHERENT DANGEROUS ACTIVITY WHICH
CANNOT BE COMPLETELY SAFE GUARDED
AGAINST, IT IS CRUCIAL THAT ALL SAFETY
PROCEDURES ARE FOLLOWED. THE INSTALLER
AND OPERATOR MUST FOLLOW ALL
ESTABLISHED PROCEDURES (INCLUDING THOSE
MENTIONED IN THIS MANUAL) TO REDUCE THE
INHERENT DANGER OF X-RAYS.

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
Front Matter
4
R302/A - Front Matter
Ralco srl
I RISCHI INERENTI ISISTEMI RADIOLOGICI SONO
RITENUTI RAGIONEVOLI SE CONFORME ALLE
NORME APPLICABILI.
L’UTILIZZO DI COLLIMATORI PER SISTEMI
RADIOLOGICI ÈSTRETTAMENTE REGOLATO.
RALCO APPLICA TUTTE LE NORME.GARANTIRE
LA SALUTE ELA SICUREZZA DEL PAZIENTE
EDELL’OPERATORE ÈCOMPITO
DELL’INSTALLATORE EDELL’OPERATORE
ASSICURANDO CHE TUTTE LE PRECAUZIONI
POSSIBILI SIANO PRESE.
THE INHERENT RISK OF USING COLLIMATORS
IN RADIOLOGICAL SYSTEMS IS DEEMED
REASONABLE AS DETERMINED BY APPLICABLE
STANDARDS. THE USE OF COLLIMATORS FOR
RADIOLOGICAL SYSTEMS IS STRICTLY
REGULATED. RALCO FOLLOWS ALL APPLICABLE
STANDARDS. ITIS UP TO THE INSTALLER AND
OPERATOR TO ENSURE THAT ALL POSSIBLE
STEPS ARE FOLLOWED TO ENSURE THE HEALTH
AND SAFETY OF THE PATIENT AND OPERATOR.
SIMBOLOGIA
NEL MANUALE SONO UTILIZZATI ISEGUENTI
SIMBOLI:
SYMBOLS
INTHIS MANUAL THE FOLLOWING SYMBOLS
ARE USED:
CON IL TRIANGOLO VENGONO EVIDENZIATI
DELLE AVVERTENZE IMPORTANTI PER LA
SICUREZZA E/OL’EFFICIENTE FUNZIONAMENTO
DELL’APPARECCHIATURA. QUESTE
AVVERTENZA SONO DA OSSERVARE
ASSOLUTAMENTE.
THE TRIANGLE EMPHASIZES WARNINGS AND
CAUTIONARY MESSAGES WHICH ARE
IMPORTANT FOR YOUR SAFETY AND/OR
EFFICIENT OPERATION OF THE EQUIPMENT.
THESE WARNINGS MUST BE STRICTLY
COMPLIED WITH.
CON LA LAMPADINA SI SI FORNISCONO
INFORMAZIONI COMPLEMENTARI PER IL
COMANDO EL’IMPIEGO PRATICO
DELL’APPARECCHIO.
INFORMATION PROVIDED WITH THE LAMP IS
ADDITIONAL ADVICE FOR THE PROPER CONTROL
AND PRATICAL USE OF THE UNIT.
IMANUALI DI ISTRUZIONE RALCO SONO
DISPONIBILI IN DUE VERSIONI: LINGUA ITALIANA
EIN LINGUA INGLESE.
PER PREVENIRE AL MASSIMO L’INDICAZIONE
DI DATI ERRATI E/ODIVERSI TRA LE DUE
VERSIONI, ALCUNI CAPITOLI CHIAVE, TIPO
SPECIFICHE ECALIBRAZIONI,SONO REDATTI
IN MODO BILINGUE.
LAVERSIONE INGLESE DI QUESTO MANUALE
ÈUNA TRADUZIONE DEL TESTO ITALIANO CHE
ÈAPPLICABILE IN CASO DI DUBBI.
RALCO INSTRUCTION MANUALS ARE AVAILABLE
IN TWO VERSIONS: ITALIAN AND ENGLISH.
TOAVOID PROVIDING INCORRECT DATA OR
INDICATIONS THAT DIFFER IN THE TWO
VERSIONS, SOME KEY CHAPTERS SUCH AS
SPECIFICATIONS AND CALIBRATION
PROCEDURES HAVE BEEN EDITED IN BOTH
LANGUAGES.
THE ENGLISH VERSION OF THIS MANUAL IS
ATRANSLATION OF THE ITALIAN TEXT WHICH
PREVAILS IN CASE OF DOUBTS.

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
Front Matter
5
R302/A - Front Matter
Ralco srl
PER ULTERIORI INFORMAZIONI RIVOLGERSI A:
RALCO, SRL
VIA DEI TIGLI 13/G
20853 BIASSONO, (MB) ITALIA
TEL: [phone]
FAX: [phone]
EMAIL: [e-mail]
FOR ANY INQUIRES OR NOTIFICATIONS, PLEASE
CONTACT US AT:
RALCO, SRL
VIA DEI TIGLI 13/G
20853 BIASSONO, (MB) ITALIA
TELEPHONE: [phone]
FAX: [phone]
EMAIL: [e-mail]

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
Description
1
R302/A - Description
Ralco srl
DESCRIPTION
Square-field, x-ray collimator suitable for installation on stationary x-ray equipment. The
collimator has been designed and manufactured for clinical skeletal and thoracic
investigations.
The x-ray field is defined by six pairs of shutters, four of which are lead-lined. The six pairs of
shutters move perpendicularly within the x-ray field. Two pairs of bronze shutters are located
near the focus, two are located near the entrance window and two are located near the exit
window of the x-ray beam from the collimator. The latter shutters serve to accurately define
the x-ray field edges.
Shutter movements are manual, controlled by two knobs on the collimator front panel.
The square field X-ray beam Limiting Device is designed for installation on fixed or rotating
anode X-ray tubes that, when mounted, conform to EN 60601-1-3 par 29.202.3. ; motorised
controls provide for the stepless adjustment of the X-ray field dimension to the size of the image
receptor or to that of the anatomical area of interest. Adjustment to the area under investigation
is possible by using the two knobs on the front panel
Direct visualisation of the x-ray field is given by a light beam which corresponds to the x-ray
beam, within a tolerance of two percent of the selected FFD (SID) value. The light-field centre
is provided by the intersection of two perpendicular lines silk-screened into the Lexan window
and projected on the light field by the light beam.
To activate the light field, press the area marked with the light symbol on the front ot the device.
The light will switch on for 30 seconds and an electronic timer will switch the lamp OFF
automatically.
Average illumination is not less than 160 LUX; edge contrast ratio is minimum > 4:1. Field size
at the different Focus Film Distance (FFD - SID) settings is shown on the front panel.
Versions:
R302/A + RO 333
R302/A DHHS + RO 333
Versione standard
Standard version

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
Description
2
R302/A - Description
Ralco srl
R302F/A + RO 333
R302F/A DHHS + RO 333
Filtrazione aggiuntiva variabile ottenuta per mezzo di un disco
di alluminio, spessore 1 mm, mosso manualmente. Sul disco,
oltre ad un foro per il passaggio del fascio radiogeno senza
filtrazione aggiuntiva, vi sono i seguenti 3 filtri:
0.1 mm di rame oltre al supporto di 1 mm di Al.
0.2 mm di rame oltre al supporto di 1 mm di Al.
1 mm di alluminio oltre al supporto 1 mm di Al.
Un fermo meccanico non permette la variazione accidentale
di filtro prescelto.
Additional variable filtration in a from of an aluminium disk, 1
mm thickness, controlled manually from the front panel. The
disk features a hole for the passage of x-rays and
accommodates the following three filters:
0.1 mm copper in addition to the 1 mm Al.
0.2 mm copper in addition to the 1 mm Al.
1 mm aluminium in addition to the 1 mm Al support.
The mechanical stop prevents filter from being accidentally
change.
R302/L + RO 333
R302/L DHHS + RO 333
Versione con laser, centratura Potter Bucky e con
alimentatore.
Version with Laser, Potter Bucky centering with power supply.
DHHS Test effettuati al 100% su tutti collimatori
Test performed on all collimators in 100%.
Fig. R302/A, R302L/A Fig. R302F/A

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
Description
3
R302/A - Description
Ralco srl
OPTIONAL ITEMS
RO 002 Distanziali in ferro spessore 1.5 mm per flangia montaggio
Spacers, iron, 1.5 mm thickness, for mounting flange
RO 012/B Metro retraibile
Tape measure, retractable
RO 023/A Distanziale fuoco-pelle
Focus-skin spacers, x-ray beam/patient
RO 041 Specchio in mylar - filtrazione interna 0,3 mm Al Equivalente
Mirror, mylar, inh. Filtr 0,3 mm Al equival.
RO 077 Centratore luminoso del Potter Bucky (BL)
Potter Bucky light centering device (BL)
RO 082 Specchio spessore 0,8 mm filtr. Int 1 mm Al equivalente
Mirror, 0,8 mm int. Filtr. 1mm
RO 342 FDA e CCSAUS certificazione estensione USA
FDA and CCSAUS certification - US extension
Fig. - R302/A, R302L/A Fig. - R302F/A

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
Description
4
R302/A - Description
Ralco srl
RO 373
Filtrazione addizionale variabile manuale (1mm+0,1mmCu oppure
1mmAl+0,2mmCu oppure 2mm Al)
Additional manual filtration (1mm+0,1mmCu or 1mmAl+0,2mmCu or 2mm
Al)
RO 375 Distanziatori plastic con supporto per camera ionizzazione
Plastic spacers with support for ionization chamber
RO 377 Dispositivo per limitare rotazione collimatore +/- 90°
Collimator rotation limiting device, +/- 90°
RO 389 Cabliaggio personalizzato
Customized wiring
RO 390 Manopole personalizzate
Customized knobs
RO 391 Copertura personalizzata
Customized cover
RO 392 Pannello frontale con serigrafia personalizzata
Front panel with customized screen printing
RO 393
Flangia rotante (diam. 136 mm, spess. 18 mm, +/-90°) con il collimatore
modificato per suo utilizzo.
Rotating flange (diam. 136 mm, thickness 18 mm, +/- 90°) with the
collimator changed for its use.
RO 394/1 Laser, centratura Potter Bucky, con alimentatore
Laser, Potter Bucky centering with power supply
THIS DEVICE IS DESIGNED TO BE USED FOR STANDARD MEDICAL OR VETERINARY
RADIOGRAPHIC INVESTIGATIONS.
ANY OTHER USE IS CONSIDERED INAPPROPRIATE.
THE CONSTRUCTOR SHALL NOT BE HELD RESPONSIBLE FOR INJURIES TO PERSONS
OR DAMAGE TO PROPERTY ENSUING FROM APPLICATIONS OTHER THAN THE INTENDED
USE; THE OPERATOR IS SOLELY RESPONSIBLE.

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
1
R302/A -
Ralco srl
SPECIFICATIONS
I dati forniti qui di seguito sono in formato
bilingue ciò per evitare discrepanze tra le
versioni.
The following indications are edited in both
languages to avoid providing contradictory
information in the two versions.
Alimentazione colimatore 12 - 45 V DC 30 VA / 20 - 30 V AC
30 VA - 50/60 Hz
12 V DC + jumper JP1
vedi Collegamento Elettrico
see Electrical Connection
Power supply
Fusibile per protezione alimentazione collimatore T 3.15 A
(non fornito) (non supplied)
Fuse for power supply protection collimator
Motori alimentati da scheda n.a.
Motor supplied by collimator board
Fusibile per protezione alimentazione motori n.a.
Fuse for power supply protection collimator
Filtrazione inerente in equivalente di alluminio
Fascio radiogeno = 70 kV
EN 60601-1-3 par. 29.201.6 / 29.201.7 Min. Al 2 mm (1mm su richiesta/
on request)
Inherent filtration Al. equivalent
X-ray beam = 70 kV
EN 60601-1-3 par. 29.201.6 / 29.201.7
Filtrazione aggiuntiva
Fascio radiogeno = 70 kV
EN 60601-1-3 par. 29.201.6 / 29.201.7
R302/A - R302L/A: n.a.
R302F/A: selezione manuale/
manual selection
1mm Al + 0,1 mm Cu
1mm Al + 0,2 mm Cu
2mm Al
Filtration, additional
X-ray beam = 70 kV
EN 60601-1-3 par. 29.201.6 / 29.201.7
Limitazione radiazione extra-focale
Distanza focale prevista, D.F.F. 1 m
EN 60601-1-3 par.29.202.3 < 150 mm
Limitation of extra focal radiation
Set focus distance, FFD (SID) 1 m
EN 60601-1-3 par.29.202.3

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
2
R302/A -
Ralco srl
Campo radiogeno quadro selezionabile
100 cm D.F.F - (± 1% FFD - SID)
EN 60601-1-3 par. 29.202.4 min. 00 x 00 cm
max. 48 x 48 cm
Square X-ray field selection
100 cm FFD (SID ) - (± 1% FFD - SID)
EN 60601-1-3 par. 29.202.4
Campo radiogeno tondo selezionabile
1 m D.F.F - (± 1% FFD - SID)
EN 60601-1-3 par. 29.202.4
n.a.
Round X-ray field selection
1 m FFD (SID ) - (± 1% FFD - SID)
EN 60601-1-3 par. 29.202.4
Indicatore luminoso di campo - luminosità
Luminosità a 1m dal fuoco, campo impostato 35 x
35 cm, Lampada alimentata 24 V.
EN 60601-1-3 par. 29.202.7 > 160 lux
Light field indicator - luminosity
luminosity at 1 m from the focus, field size set at 35x35
cm, Halogen Lamp 24 V .
EN 60601-1-3 par. 29.202.7
Indicatore luminoso di campo- contrasto
Contrasto ai bordi impostando 35x 35 cm a 1m dal
fuocoEN 60601-1-3 par. 29.202.7 > 4:1
Light field indicator - contrast
edge contrast setting 35x35 cm at 1 m FFD (SID)
EN 60601-1-3 par. 29.202.7
Precisione dell’indicatore luminoso di campo
Corrispondenza con il campo radiogeno
EN 60601-1-3 par. 29.202.9 < 1 % FFD - SID>
Light field indicator precision
Light field/x-ray field correspondence
EN 60601-1-3 par. 29.202.9
Precisione dell’indicazione di campo RX
Impostazione indice su scala graduata
EN 60601-1-3 par. 29.202.8 < 2 % FFD - SID
X-ray field indication precision
Settings on an index scale
EN 60601-1-3 par. 29.202.8
Distanza fuoco ricettore : (optional)
Precisione indicazione con metro retraibile
EN 60601-1-3 par. 29.203.2 < 2% FFD - SID
FDD (SID): (optional)
Precision of measurement with retractable tape
EN 60601-1-3 par. 29.203.2

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
3
R302/A -
Ralco srl
Radiazione di fuga:
Misurata a 100 cm dal fuoco con fascio radiogeno =
150 kVp - 4 mA- EN 60601-1-3 par. 29.204.3 < 40 mRh
Leakage radiation
Measured at 100 cm with x-ray beam = 150 kVp - 4 mA
- EN 60601-1-3 par. 29.204.3
Potenziometri
Campo quadro
Campo tondo n.a. n.a.
Potentiometers
Square field
Round field
n.a.
n.a.
Portata massima delle guide porta-accessori
GUIDE PORTA ACCESSORI - PRIMA DI INSERIRE UN ACCESSORIO
NELLE APPOSITE GUIDE, VERIFICARE CHE LE DIMENSIONI COIN-
CIDANO PERFETTAMENTE (TOLLERANZA MAX. +/- 0,5 MM). UNA
DIMENSIONE NON CORRETTA POTREBBE GENERARE SITUAZIONI DI
PERICOLO E/OCADUTA DELL’ACCESSORIO
Carico statico:70N (circa 7.1
Kg)
Carico dinamico:15Nm (circa
3.06 Kg)
Maximum load for accessory guides
GUIDES FOR ACCESSORIES (IF ASSEMBLED): PRIOR TO INSERTING
ACCESORIES IN THE GUIDES CHECK ON THE PERFECT ATTACHMENT
OF THE SUPPORT WITH THE MOUNTING SLOT ON THE COLLIMATOR
(TOLERANCE MAX. ± 0,5 MM). AFAULTY ATTACHMENT COULD BE
DANGEROUS AND IT COULD CAUSE THE FALL OF ACCESSORIES
Static load: 70N (about 7.1 Kg)
Dynamic load:15Nm (approx.
3.06 Kg)
Ambiente di funzionamento
• Temperatura ambiente
• Umidità relativa
• Pressione atmosferica 10°- 40° C
30% - 75%
700 - 1060 hPa
Operation environment
• Ambient temperature
• Relative humidity
• Atmospheric pressure
Condizioni di immagazzinamento
• Temperatura
•Umidità
• Pressione atmosferica -40° - 70°C
10% - 95%
500 - 1060 hPa
Storage
• Temperature
•Humidity
• Atmospheric pressure
Peso
Weight 9,4 kg
Dimensioni
Dimensions
L: 246 mm
W: 223 mm
H: 140 mm
Software GC-Led-5A Version 1.01

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
4
R302/A -
Ralco srl
Validation of Specification Data
• Validation of minimum filtration of the radiation unit (x-ray tube, collimator and possible fil-
ters) must be performed on a completely installed system by whoever is responsible for
the installation.
• Validation of light field luminosity and contrast is performed in-factory. See Chapter - COM-
PLIANCE VERIFICATION, PARAGRAPH: LIGHT FIELD ILLUMINATION INTENSITY.
• Validation of system x-ray leakage is to be performed following the installation of the sys-
tem components under the responsibility of the person performing the installation.
• The correct installation of the system, electronic calibration and wiring layout of the same
are the responsibility of the engineer responsible for the installation of the system.
• Protection of the cable is to be provided by the installation engineer.
Ralco is prepared to provide any information required regarding the validation methods
described above.
EN 60825-1 par.1 -5
The collimator laser is classified as Class 2M; the light-field led is classified as Class 2 and is
used for light field projection.
Alimentazione scheda esterna
n.a.
Power supply, external PCB
Fusibile per scheda esterna
n.a.
Fuse for external board
CLASS 2 LED PRODUCT=> WHITE LED
CLASS 2M LASER PRODUCT=>RED LASER LINE

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
5
R302/A -
Ralco srl
EN 60601-1 par. 5
• Protection against electric hazards: "Class I" equipment.
• Protection against direct and indirect contacts: Type B equipment with applied parts.
• Protection against water see page: "Common equipment".
• Safety of operation in the presence of inflammable anaesthetics with air or oxygen or
nitrous oxide: Equipment not suited to application in the presence of inflammable anaes-
thetic mixtures containing air or oxygen or nitrous oxide.
• Operation conditions: Equipment for continuous operation at intermittent loads - See Chap-
ter - OPERATION INSTRUCTIONS.
• Should label data on the collimator not correspond to the specifications herein, inform
Ralco of the non conformity.
• Verifications of the specifications are to be performed according to the indicated equipment
standards.
Operation Environment
• Ambient temperature = from 10°C to 40°C
• Relative Humidity = from 30% to 75%
• Atm. Press. = from 700 to 1060 hPa
Storage
• Temperature from -40°C to 70°C
• Humidity from 10% to 95%
• Atm. Pressure from 500 to 1600 hPa
The device may be stored in its original packing for some time before it is installed. However,
even if each metal part has been accurately protected with specific varnish or superficial
oxidation treatment, the device has not been designed for outdoor use or storage. The device
is sensitive to humidity; avoid keeping it outdoors or using it in unsuitable conditions.
EN 60601-1-3 para. 29.205 - Focus-Skin Distance
Paragraphs 29.205.1 - 29.205.3 of the above standard deal with preventing the use of
inappropriate small focus/skin distances in order that the dose equivalent to the patient be kept
as low as reasonably achievable.
A focus-skin spacer for each collimator type is available on request.
29.205.1 - Radiation Equipment for Fluoroscopy
X-ray devices for fluoroscopy must feature characteristics that, during fluoroscopy, will prevent
focus-skin distances less than:
• 20 cm if the x-ray device is specifically for fluoroscopy.
• 30 cm for other applications.
Conformity is measured and checked visually. The x-ray system must comply with the norm;
this means that the operator is responsible for the verification. A focus/skin spacer device is an
option made available by Ralco.
GUIDES FOR ACCESSORIES (IF ASSEMBLED): PRIOR TO INSERTING ACCESORIES
IN THE GUIDES CHECK ON THE PERFECT ATTACHMENT OF THE SUPPORT
WITH THE MOUNTING SLOT ON THE COLLIMATOR (TOLERANCE MAX. ± 0,5
MM). AFAULTY ATTACHMENT COULD BE DANGEROUS AND IT COULD CAUSE
THE FALL OF ACCESSORIES

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
6
R302/A -
Ralco srl

MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R302/A
Tube Compatibility
1
R302/A - Tube Compatibility
Ralco srl
TUBE COMPATIBILITY
Fig.
N.B. I dati forniti qui di seguito sono in formato
bilingue ciò per evitare discrepanze tra le
versioni.
N.B. The following indications are edited in
both languages to avoid providing
contradictory information in the two versions.
• La compatibilità tra il collimatore ed il tubo
radiogeno è determinata dalla possibilità
meccanica di montarli - vedi la Figura che
segue.
• Accertarsi, consultando il manuale tecnico
della cuffia radiogena, che la filtrazione
interna minima sia conforme (1mm) ed
abbia una perdita massima di radiazione di
30 mr/hr misurati ad un 1m dalla sorgente
(150 kVp - 4 mA).
• I valori della sorgente (cuffia radiogena-
collimatore) non devono essere inferiori a
3 mm di Alluminio per la filtrazione e non
oltrepassare 100 mR/Hr per la perdita di
radiazioni. (EN 60601-1-3 par. 29.201.7/
29.201.6 e 21 CFR sub-chapter J, part
1020.30 (m) (1).
• La flangia di montaggio del collimatore
deve essere fornita con il collimatore.
• La distanza dal fuoco del tubo radiogeno al
piano di montaggio della flangia (piastra
superiore del collimatore) deve essere: 80
mm (3.14"), tolleranza +/- 1 mm (0.04”).
• Collimator/x-ray tube compatibility is deter-
mined by the mechanical possibility of
mounting them.
See the following Figure.
• Check that the tube housing literature indi-
cates congruent minimum inherent filtra-
tion (1mm) and, that maximum radiation
leakage is 30 mr/hour measured at 1 m
from the source when operating at its leak-
age technique factors (150 kVp - 4 mA).
• Source values (tube housing-collimator)
must not be less than 3 mm Al for filtration
and must never exceed 100 mR/hr for radi-
ation leakage.
(EN 60601-1-3 par. 29.201.7/29.201.6 e
21 CFR sub-chapter J, part 1020.30 (m)
(1).
• The collimator mounting flange must be
provided with the collimator.
• The distance between the x-ray tube
focus and the flange mounting plane (colli-
mator upper plate) must be:
80 mm (3.14"), tollerance +/- 1mm (0.04”).
generali\06_compt_manuali