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MTR302/A - R302F/A - R302L/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL

Modello/Model R302/A

Front Matter

1

R302/A

- F

ront

Matt

er

Ralco

srl

FRONT MATTER

I

L

PRESENTE

MANUALE

D

’

ISTRUZIONI

DEVE

ESSERE

LETTO

E

COMPRESO

NEL

SUO

COMPLESSO

DA

L

’

INSTALLATORE

E

L

’

OPERATORE

.

T

HE

FOLLOWING

INSTRUCTION

MANUAL

MUST

BE

READ

AND

UNDERSTOOD

IN

ITS

ENTIRETY

BY

THE

INSTALLER

AND

OPERATOR

.

I

L

COLLIMATORE

È

DESTINATO

AD

ESSERE

COLLEGATO

AD

UNA

MACCHINA

RADIOLOGICA

CHE

PRODUCE

RADIAZIONI

IONIZZANTI

PER

USO

MEDICO

O

VETERNINARIO

.

CHIUNQUE

SIA

AUTORIZZATO

AD

INTERVENIRE

SULL

’

APPARECCHIATURA

RADIOLOGICA

DEVE

ESSERE

PIENAMENTE

A

CONOSCENZA

DELLE

PROCEDURE

RIGUARDANTI

LA

PROTEZIONE

CONTRO

LE

RADIAZIONI

,

DELL

’

UTILIZZO

DELL

’

APPARECCHIATURA

E

DELLA

MANUTENZIONE

DI

ESSA

.

R

ALCO

NON

È

RESPONSABILE

DI

EVENTUALI

DANNI

A

COSE

E

/

O

A

PERSONE

DERIVANTI

DALL

’

UTILIZZO

IMPROPRIO

E

/

O

SCORRETTO

DEL

COLLIMATORE

.

Q

UESTO

MANUALE

DEVE

ESSERE

DISPONIBILE

PER

L

’

INSTALLATORE

E

L

’

OPERATORE

.

I

NTENDED

U

SE

OF

THE

C

OLLIMATOR

T

HIS

COLLIMATOR

IS

DESIGNED

TO

BE

USED

WITH

A

R

ADIOLOGICAL

SYSTEM

PRODUCING

IONIZING

RADIATION

FOR

MEDICAL

OR

VETERINARY

USE

.

W

HOEVER

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

.

R

ALCO

IS

NOT

RESPONSIBLE

FOR

ANY

PERSONAL

INJURIES

OR

DAMAGE

TO

PROPERTY

FROM

MISUSE

OR

UNINTENDED

USE

OF

THE

COLLIMATOR

.

T

HIS

MANUAL

MUST

BE

MADE

AVAILABLE

TO

THE

INSTALLER

AND

OPERATOR

.

R

ESPONSABILITÀ

DELL

’

INSTALLATORE

E

DELL

’

OPERATORE

L’

INSTALLATORE

E

L

’

OPERATORE

,

DOPO

L

’

INSTALLAZIONE

E

PRIMA

DI

OGNI

UTILIZZO

,

DEVONO

VERIFICARE

CHE

TUTTE

LE

NORMATIVE

RIGUARDANTI

LA

SICUREZZA

SIANO

STATE

APPLICATE

. T

UTTE

LE

PROCEDURE

RIGUARDANTI

L

’

INSTALLAZIONE

E

L

’

UTILIZZO

SICURO

DEL

COLLIMATORE

DEVONO

ESSERE

SCRUPOLOSAMENTE

OSSERVATE

.

I

NSTALLER

AND

O

PERATOR

R

ESPONSIBILITY

T

HE

INSTALLER

AND

OPERATOR

MUST

VERIFY

THAT

ALL

SAFETY

STANDARDS

ARE

FOLLOWED

IMMEDIATELY

AFTER

INSTALLATION

OF

THE

COLLIMATOR

AND

BEFORE

ANY

SUBSEQUENT

USE

.

A

LL

PROCEDURES

REGARDING

THE

INSTALLATION

AND

SAFE

USE

OF

THIS

COLLIMATOR

MUST

BE

STRICTLY

FOLLOWED

.

S

EGNALAZIONI

L

E

INFORMAZIONI

RIGUARDANTI

EVENTUALI

INCIDENTI

VERIFICATISI

DURANTE

L

'

UTILIZZO

DEL

COLLIMATORE

RADIOLOGICO

VANNO

COMUNICATE

IMMEDIATAMENTE

ALLA

R

ALCO

S

.

R

.

L

.

R

EPORTING

I

NFORMATION

REGARDING

ACCIDENTS

THAT

HAVE

OCCURRED

WHILE

USING

THE

COLLIMATOR

MUST

BE

REPORTED

IMMEDIATELY

TO

R

ALCO

,

SRL

.

«
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4
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Summary of Contents for R 302F/A

Page 1: ...te of Issue 11 02 2011 Revision Level C Issued by Ralco s r l MANUALE ISTRUZIONI INSTRUCTION MANUAL Ralcos r l R302 A COLLIMATORE RADIOLOGICO MANUALE MANUAL X RAY COLLIMATOR MTR302 A R302F A R302L A DHHS ...

Page 2: ...DA 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 01...

Page 3: ...OR 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 Elec...

Page 4: ...MTR302 A R302F A R302L A DHHS Contents 2 ...

Page 5: ...HOEVER 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 INSTALLATO...

Page 6: ...HOUT RESPECTING THE INSTRUCTIONS AS PROVIDED IN THIS MANUAL THE COLLIMATOR WAS USED IN A WAY OUTSIDE ITS INTENDED USE THE COLLIMATOR WAS NOT INSTALLED BY COMPETENT PERSONNEL THE COLLIMATOR WAS NOT OPERATED SAFELY OR IN A WAY 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 RA...

Page 7: ...TIONS 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 IL COLLIMATORE È COSTRUITO RI...

Page 8: ...ER LA SICUREZZA E O L 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 E L IMPIEGO PRATICO DEL...

Page 9: ... srl PER ULTERIORI INFORMAZIONI RIVOLGERSI A RALCO SRL VIA DEI TIGLI 13 G 20853 BIASSONO MB ITALIA TEL 39 039 2497925 FAX 39 039 2497799 EMAIL RALCO RALCO IT FOR ANY INQUIRES OR NOTIFICATIONS PLEASE CONTACT US AT RALCO SRL VIA DEI TIGLI 13 G 20853 BIASSONO MB ITALIA TELEPHONE 39 039 2497925 FAX 39 039 2497799 EMAIL RALCO RALCO IT ...

Page 10: ...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 cor...

Page 11: ...anico 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 ...

Page 12: ...easure 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 certif...

Page 13: ...onalizzate 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 c...

Page 14: ...entati 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 aggiun...

Page 15: ...t 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 ...

Page 16: ...L 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 A FAULTY ATTACHMENT COULD BE DANGEROUS AND IT COULD CAUSE THE FALL OF ACCESSORIES Static load 70N...

Page 17: ...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 rega...

Page 18: ...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 ...

Page 19: ...MTR302 A R302F A R302L A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R302 A 6 R302 A Ralco srl ...

Page 20: ...adiazioni 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 ...

Page 21: ... collimator with the tube to determine that the primary shutters have enough clearance to move in the port opening and in the mounting flange See Figure Chapter COMPATIBILITY COLLIMATOR X RAY TUBE Note Collimators without extra focal shutters do note require the preceding two controls Place the collimator on the flange Tighten the four mounting screws equally until the colli mator holds firmly on ...

Page 22: ...at the distance between the collimator housing and the mounting flange is equal in all directions and that the collimator face is parallel to the axis of the table Loosen the screws and adjust if required Tube collimator mounting flange IF THE COLLIMATOR IS TO BE MOUNTED ON A ROTATING FLANGE USE A TIGHTENING FORCE BETWEEN MIN 0 50 NM AND MAX 0 75 NM ...

Page 23: ...MTR302 A R302F A R302L A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R302 A Installation 3 R302 A Installation Ralco srl Fig Flange Mounting ...

Page 24: ...GRAM INCLUDED IN THIS CHAPTER REFERS TO THE STANDARD PRODUCT IT IS THE RESPONSIBILITY OF THE CUSTOMER WHO HAS REQUESTED AN ELECTRIC CUSTOMIZATION TO ENSURE THAT AN ELECTRIC DIAGRAM RELATING TO THE CUSTOMIZATION HAS BEEN PROVIDED WITH THE DOCUMENTATION COLLIMATOR MUST BE SUPPLIED AS SPECIFIED SEE SPECIFICATIONS THE SUPPLY MUST COME FROM A SEPARATE SOURCE FROM THE POWER NETWORK THROUGH DOUBLE INSULA...

Page 25: ...MTR302 A R302F A R302L A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R302 A Electrical Connection 2 R302 A Electrical Connection Ralco srl R302 A ...

Page 26: ...MTR302 A R302F A R302L A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R302 A Electrical Connection 3 R302 A Electrical Connection Ralco srl Fig 302L A ...

Page 27: ...ternal pushbutton 8 GND Power up external pushbutton J1 Led Output 1 Led 5A positive output 2 GND Led 5A J3 Programing Connectors 1 Vpp 2 5V 3 GND 4 PGD 5 PGC 6 NC J4 Home Sensor Input External Led 1 External Led 2 External Led 3 Photosensor Led Cathode 4 Photosensor Led Anode 5 Input signal Photosensor output collector 6 GND Photosensor output emitter Jumpers OFF without jumper ON with jumper JP1...

Page 28: ...nsor over the hole External Led OFF Important JP7 Programming of Microcontroller Pic16F52 OFF Pic16F526 may be programmed by removing JP8 thermistor input from Pic ON JP8 connected to Pic prevents re programing Trimmers TR1 Current Control Adjusts the output current intensity to the Led Stepless current adjustment from 0 to 5 1 A Adjusting current to approx 4 7 A will increase Led life without a s...

Page 29: ...MTR302 A R302F A R302L A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R302 A Electrical Connection 6 R302 A Electrical Connection Ralco srl ...

Page 30: ... and replaced in the same position Place white paper on top of the cassette to provide maximum contrast for the light field Set the collimator to provide a field size of 30x30 cm 14x14 at one meter 40 Activate the light field and use it to position 18 coins as shown in the diagram Position each pair of coins touching one another so that the inner coin is lighted as much as possible and the outer c...

Page 31: ...ible is achieved If misalignment is detected in both X and Y directions check that spacing from the focal spot to the collimator mounting surface is 80 mm 3 14 1 mm If spacing needs to be adjusted repeat the test film exposure after the adjustment If the collimator mount spacing is correct but adjustment is still necessary proceed as follows Place the test film on the face of the cassette over the...

Page 32: ...ting screw D If the light field is bigger than the x ray field raise the led by adjusting screws D Tighten the two screws C See the following Figure Fig Light field x ray field adjustment Transversal Calibration CROSS If the light field needs calibration the mirror needs to be adjusted as follows Remove the part of the cover necessary to access the screws see Chapter COVER REMOVAL Loosen the mirro...

Page 33: ... DELLA COPERTURA TIGHTEN THE FOUR ALEN SCREWS TO ALLOW REMOVAL OF THE COVER 2 TOGLIERE LE DUE MANOPOLE DAL PANNELLO FRONTALE SVITANDO I 2 GRANI PER MANOPOLA REMOVE THE FRONT PANEL BY UNSCREWING THE TWO DOWELS PER KNOB 3 TOGLIERE LA FACCIATA AD INCASTRO SOLLEVANDOLA CON LE DITA COME MOSTRATO NELLA FOTO REMOVE THE SNAP FIT FRONT PANEL BY PRISING IT OFF AS SHOW IN THE PHOTOGRAPH ...

Page 34: ...GLIERE IL FERMO ALLARGANDOLO DALLA BANDELLA E SFILANDOLO QUINDI SFILARE LA BANDELLA E FARLA RIENTRARE ALL INTERNO DEL COLLIMATORE IN COLLIMATORS WITH MEASURING TAPES REMOVE THE TAPE STOP BY LIFTING IT OFF WITH A SCREW DRIVER GENTLY EASE THE TAPE INTO ITS CONTAINER WITHIN THE COLLIMATOR 6 GIRARE IL COLLIMATORE DALLA PARTE INFERIORE E SVITARE LE 4 VITI TURN THE COLLIMATOR OVER AND UNSCREW THE FOUR S...

Page 35: ...REMOVE THE REAR COVER BY UNSCREWING THE THREE SCREWS 8 APPOGGIARE IL COLLIMATORE SULLA PARTE POSTERIORE LEGGERMENTE SOLLEVATO E SFILARE LA MEZZALUNA PLACE THE COLLIMATOR LOWER SIDE DOWN AND SLIGHTLY RAISE SLIP THE SEMI CIRCLE OUT 9 SFILARE LE COPERTURE LENTAMENTE LO SPORTELLO SI LIBERA DA SOLO EASE THE COVER UPWARDS GENTLY THIS WILL ALSO RELEASE THE SMALL PANEL ...

Page 36: ...ONTARE LE MANOPOLE E O IL PANNELLO ANTERIORE E SECONDO DEL MODELLO DI COLLIMATORE ACCESS TO THE LASER BY REMOVING THE TWO KNOBS AND OR THE FRONT PANEL DEPENDING ON THE COLLIMATOR MODEL PER ACCEDERE ALLE FRIZIONI SMONTARE LE MANOPOLE E O IL PANNELLO ANTERIORE E SECONDO DEL MODELLO DI COLLIMATORE ACCESS THE CLUTCHES BY REMOVING THE TWO KNOBS AND OR THE FRONT PANEL DEPENDING ON THE COLLIMATOR MODEL ...

Page 37: ...e maximum mechanical value Forcing and or extending the tape beyond this point will cause the following inconveniences Breakage of the tape or Distortion of the tape or Impossibility of retracting the tape into its lodging because the grip of the spring has been forced and hook up is consequently distorted NOTE DO NOT EXTEND THE TAPE BEYOND THE INDICATION OF STOP PER ACCEDERE ALLA SCHEDA ELETTRONI...

Page 38: ... ISTRUZIONI INSTRUCTION MANUAL Modello Model R302 A 6 R302 A Ralco srl Longitudinal Movement PER ACCEDERE ALLO SPOSTAMENTO LONGITUDINALE RIMUOVERE LO SPORTELLO LATERALE ACCESS THE LOGITUDINAL ADJUSTMENT PARTS BY REMOVING THE LATERAL PLATE ...

Page 39: ... line constructed against the antidust plastic panel toward the control face of the collimator To adjust the position of the line shift the light support group as required Note that the support group and bracket are inside the collimator frame and cannot be seen but may be controlled by the two securing screws as shown CROSSHAIR ADJUSTMENT Activate the light field Adjust the light field to a narro...

Page 40: ...tely closed See Shutter Dial Adjustment in this Chapter MECHANICAL MOTION STOP ADJUSTMENT The purpose of these stops is to prevent stressing the control shafts of the shutters at the two limits of travel This is done by limiting rotation of the control shafts Adjustment of these stops will no the required unless the shutters can not be completely closed or opened to the largest size torsion is fel...

Page 41: ...ly excessive force to check that the shutters touch Use the field light to check that shutters are closed Rotate the cam stop to a standstill Tighten the Allen screw Open and close the shutters several times to check that they close open fully and that when they close the cam touches the stop Closed Stop LASER LIGHT IMAGE RECEPTOR ALIGNMENT Class II laser beam 1mW wavelength 635mm CAUTION CLASS II...

Page 42: ...system To rotate the laser system loosen the Allen screw on the metal strip holding the laser See Laser Adjustment Tighten the Allen screw when the laser beam falls on or is parallel to the bisector line drawn on the anti dust panel Shift the laser system by loosening the two screws holding the laser system base to the beam limiting device front plate Move the base until the laser beam falls over ...

Page 43: ...MTR302 A R302F A R302L A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R302 A Adjustments 5 R302 A Adjustments Ralco srl Fig Laser Control ...

Page 44: ...vering Electromedical equipment The above HVL requirements can be met if it is demonstrated that the aluminium equivalent in the primary beam is not less than that shown in the following table The information contained in the above table was extracted from the Code of Federal Regulations FDA 21 1020 30 m THE FOLLOWING PROCEDURES REQUIRE THAT X RADIATION BE PRODUCED TAKE ADEQUATE PRECAUTIONS THAT N...

Page 45: ... shown in the table a Direct the central x ray beam perpendicular and in the center of a RAD Check instrument Determine the exact distance from the x ray tube focal spot to the window of the collimator 273 mm 10 75 Place the input area of the RAD CHECK at an equal distance from the collimator window Collimate the beam to an area slightly larger than the detector b Make an exposure at a pre selecte...

Page 46: ...or each increments of filtration and record the reading c Plot the exposure readings log scale versus the total added filtration thickness on semilog paper see the sample hereunder d Verify that HLV values in the useful beam for the above specific tube potential is not less than the values shown in Table Minimum Filtration Requirement Beam Quality Hvl VISUAL DEFINITION OF X RAY VERSUS LIGHT FIELD ...

Page 47: ...in the light beam are clean and unobstructed d Place a photometer capable of reading up to 160 lux in the centre of each of the four quadrants of the light field e Turn on the light beam and read the light intensity subtract to it the ambient lighting previously determined f Verify that the average illumination is higher than 160 lux g Verify that the contrast ratio is performed between two points...

Page 48: ...llo Automatico Automatic Control closed loop 01 46 iso 7000 0017 Diaframma a Iride Aperto Iris Diaphragm Open 01 69 iso 7000 0017 Diaframma a Iride Chiuso Iris Disaphragm Closed 01 70 417 iec 5324 Attenzione situazione di pericolo Warning possible hazard 03 02 iec 601 1 Filtro di Radiazione Oppure Filtrazione Radiation Filter or Filtration 04 51 417 iec 5381 Indicatore Luminoso del Campo di Radiaz...

Page 49: ...one Radiazione Laser Caution Laser Radiation 60825 1 Dispositivo Sensibile all Energia Elettrostatica Electrostatic Sensitive Device Dispositivo Impostazione Dimensione Cassetta Cassette Size Sensing Device Dispositivo che Richiede un Corretto Smaltimento Device Requiring Proper Disposal attch 4 2002 95 CE Attenzione Consultare la Documentazione Annessa Warning Read the Attached Documents Descrizi...

Page 50: ...p 1 The Collimator R302 A uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A This R302 A is suitable for use in all establishments other than domestic and those directly connected to the low voltage power supply network which supplies buildings used for domes...

Page 51: ...netic Environment Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air EN 60601 1 2 test level Hospital Electronical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 3m EN 60601 1 2 test level Hospital Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode EN 60601 1 2 test level Hospital Voltage dips short interruptions and voltage variati...

Page 52: ...lian ce Level Electromagnetic Environment Portable and mobile RF communications equipment should be used no closer to any part of the R302 A including cables then the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m d 1 2 P 80 MHz to 800MHz d 2 3 P 800 ...

Page 53: ...rification 10 R302 A Compliance Verification Ralco srl Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Table 2 ...

Page 54: ...equipment Rated Maximum Output Power of Transmitter W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz d 1 2 x P 80 MHz to 800 MHz d 1 2 x P 800 MHz to 2 5 GHz d 0 2 3 x P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m ca...

Page 55: ... is factory set at 30s tol 20 It is adjustable from 30 to 45 seconds via a trimmer on the timer board The normal ON OFF cycle is set at 1 minute followed by an idle time of 4 minutes to allow for cooling time i e 1 minute ON 4 minutes OFF The field is set by the two knobs on the front panel by following the indications of the scale with the knob index or visually with the light field Front Panel W...

Page 56: ...ia verticale con la riga del formato cassetta in cm o inch freccia orizzontale Se necessario riferirsi al Capitolo REGOLAZIONI The table provides the readout of the numbers which must be set with the knobs The exact number to be set is obtained by crossing the FFD SID in use the value indicated by vertical arrow with the Cassette size value in cm or inches horizontal arrow If necessary see Chapter...

Page 57: ...witch ON Collimator supplied incorrectly Check supply tension current polarity fuses Faulty light source Check item Replace if necessary See SUBSTITUTIONS Faulty timer Check timer supply Substitute if necessary See SUBSTITUTIONS Faulty ON OFF pushbutton Check contact Sustitute if necessary Light source fails to switch OFF Faulty timer Substitute timer Pushbutton is shorted Substitute pusbutton Pro...

Page 58: ...ve part of the cover to access the component See Chapter COVER REMOVAL Remove the two screws holding the electronic timer Identify the cables and their position on the terminal board See Chapter ELECTRICAL CONNECTION Disconnect the cables from the terminal board Install the new timer by proceeding in a reverse order pay particular attention to the con nection of the cables on the 2 or 8 way electr...

Page 59: ...ns Ralco srl SUBSTITUTION OF THE MIRROR Remove the collimator cover front panel and rear cover See Chapter COVER REMOVAL Remove the collimator lateral pro tection walls Remove the mirror shaft stop on the left side of the collimator Remove the three screws on the upper left partition Remove the two screws on the cable stops ...

Page 60: ...302 A Substitutions 3 R302 A Substitutions Ralco srl Remove the cable stop located on front partition of the collimator on the upper righthand side Remove the screw on the rear parti tion of the collimator on the upper lefthand side Lift off the upper part of the right hand partition ...

Page 61: ...MTR302 A R302F A R302L A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R302 A Substitutions 4 R302 A Substitutions Ralco srl Substitute the mirror and re mount in reversed order ...

Page 62: ...Metro retraibile in acciaio Tape measurem steel retractable RS 780 A Specchio vetro con supporto Mirror with support RS 797 Pannello frontale piombato dal n s 13028 Panel front leaded from S n 13028 RS 798 Pannello frontale piombato Panel front leaded RS1064 Scheda GC Led 5A GC Led 5A board RS1065 Led Led RS1106 Ventola Led Led fan RS1149 Pannello antipolvere Panel antidust RS1150 Pannello antipol...

Page 63: ...essori Guide for accessories right RS 395 Guida sinistra per accessori Guide for accessories right RS 402 Pannello laterale piombato Guide for accessories left RS 403 Copertura superiore mezzaluna Cover upper semicircular RS 409 Laser Laser RS 424 Cornice plastica Frame plastic RS 596 Viti fissaggio copertura T C M3X25 Screws fixing for cover T C M3x25 RS 649 Metro retraibile in acciaio Tape measu...

Page 64: ...TRUZIONI INSTRUCTION MANUAL Modello Model R302 A Spare Parts 3 R302 A Spare Parts Ralco srl R302 A DHH R302F A R302F A DHHS R302L A 302L A DHHS etichetta 302_A_DHHS etichetta 302F A etichetta 302F A_DHHS etichetta 302L A_ ichetta 302L A DHHS ...

Page 65: ...MTR302 A R302F A R302L A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R302 A Spare Parts 4 R302 A Spare Parts Ralco srl R 302L A LABEL 1 LABEL 2 LABEL 3 LABEL 4 LABEL 5 ...

Page 66: ...MTR302 A R302F A R302L A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R302 A Spare Parts 5 R302 A Spare Parts Ralco srl R302L A DHHS LABEL 1 LABEL 2 LABEL 3 LABEL 4 LABEL 5 ...

Page 67: ...MTR302 A R302F A R302L A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R302 A Spare Parts 6 R302 A Spare Parts Ralco srl Parts Breakdown R302 A R302 A DHHS ...

Page 68: ...MTR302 A R302F A R302L A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R302 A Spare Parts 7 R302 A Spare Parts Ralco srl R302F A R302F A DHHS ...

Page 69: ...MTR302 A R302F A R302L A DHHS MANUALE ISTRUZIONI INSTRUCTION MANUAL Modello Model R302 A Spare Parts 8 R302 A Spare Parts Ralco srl R302L A R302L A DHHS ...

Page 70: ...y applicable normes and directives covering disinfection and protection against explosion hazards Disconnect supply Disinfect the unit including accessories and cables with a dampened cloth Do not spray the unit with the disinfectant because it could leak into the collimator RECOMMENDED MAINTENANCE PROGRAMME Ralco suggests a yearly servicing programme However shorter intervals are advisable when t...

Page 71: ... particular attention to the Lexan window Do not use abrasive or inflammable cleaning products Wipe away all excess oil and remount the cover MAKE SURE TO TIGHTEN THE M6 ALLEN SCREWS SECURING THE COLLIMATOR OR THE CONTROL TABS APPROPRIATE TIGHTENING OF THE 4 ALLEN SCREWS ENSURES SECURE MOUNTING OF THE COLLIMATOR TIGHTENING FORCE USED MUST NOT EXCEED 0 50 NM IF THE COLLIMATOR IS TO BE MOUNTED ON A ...

Page 72: ...void direct contact with lead especially for prolonged periods It is recommended that you observe Local Laws regulating the disposal of your old set Should this prove impossible return the collimator to Ralco at the purchaser s expense and Ralco will undertake its correct disposal The product requires correct disposal at the end of its life cycle and according to the current standards it cannot be...

Page 73: ...tors 1 year Potentiometres 1 year Electronic Boards 1 year Laser 12 months Ralco reserves the right to decide if the collimator is to be repaired or substituted Defective material is to be sent to RALCO SRL VIA DEI TIGLI 13 G 20853 BIASSONO MI ITALIA FAX 39 039 2497 799 EMAIL RALCO RALCO IT DISASSEMBLY Disconnect supply to the collimator Remove the cover and disconnect the supply cables Loosen the...

Page 74: ... unit has not been subject to routine functional inspection The unit has not been subject to routine maintenance The unit has been repaired with unoriginal spare parts Ralco shall decline all responsibility for any damage direct or indirect caused to persons or things by inappropriate accessories RESIDUAL RISKS The collimator has been constructed to current standards to meet the safety requisites ...

Page 75: ...atore R302 A è stato personalizzato nei seguenti modelli Le specifiche relative a un dato modello saranno fornite al cliente che ordina quel dato modello in allegato a questo manuale Collimator R302 A has been customized in the following models The specifications related to a given model will be supplied with this manual to the customer ordering that particular model ...

Page 76: ...ni riguardanti eventuali incidenti verificatisi con l utilizzo del collimatore radiologico La direttiva 2007 47 CE prevede che incidenti quali la morte o grave peggioramento dello stato di salute di un paziente che vedano coinvolto il collimatore radiologico qui descritto vengano segnalati al Ministero della Sanità e al Costruttore Il presente modulo serve per segnalare alla ralco srl tali eventua...

Page 77: ...info_cl fm ...

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