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Versione standard. R 302/a Standard version. Versione certificata FDA disponibile su richiesta R 302/A DHHS FDA certified version available on request. Versione standard. R 302F/A Versione certificata FDA disponibile su richiesta R 302F/a DHHS FDA certified version available on request. Versione standard R 302L/A Versione certificata FDA...
Modello/Model R302/A Ralco FRONT MATTER ’ L PRESENTE MANUALE D ISTRUZIONI DEVE HE FOLLOWING INSTRUCTION MANUAL MUST ESSERE LETTO E COMPRESO NEL SUO BE READ AND UNDERSTOOD IN ITS ENTIRETY ’ COMPLESSO DA L INSTALLATORE E BY THE INSTALLER AND OPERATOR ’...
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Modello/Model R302/A Ralco ESPONSABILITÀ LIMITATA IMITATION OF IABILITY ALCO DECLINA OGNI RESPONSABILITÀ ALCO IS NOT LIABLE IF THE PROVIDED QUALORA NON VENGANO RISPETTATE LE INSTRUCTIONS ARE NOT COMPLIED WITH INDICAZIONI DEL PRESENTE MANUALE TECNICO URTHERMORE ALCO IS NOT LIABLE IF ONE NOLTRE LA RESPONSABILITÀ...
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Modello/Model R302/A Ralco L COLLIMATORE IN OGGETTO UTILIZZATO SU HE COLLIMATOR DESCRIBED HERE IS USED APPARECCHIATURE RADIOLOGICHE È ADIOLOGICAL SYSTEMS AND IS CLASSIFIED ’ CLASSIFICATO TIPO IIB SECONDO L ALLEGATO AS A TYPE ACCORDING TO TTACHMENT IL COLLIMATORE È STATO PROGETTATO IX.
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’ COMANDO E L IMPIEGO PRATICO AND PRATICAL USE OF THE UNIT ’ DELL APPARECCHIO I MANUALI DI ISTRUZIONE RALCO SONO ALCO INSTRUCTION MANUALS ARE AVAILABLE DISPONIBILI IN DUE VERSIONI LINGUA ITALIANA IN TWO VERSIONS TALIAN AND NGLISH E IN LINGUA INGLESE O AVOID PROVIDING INCORRECT DATA OR ’...
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Modello/Model R302/A Ralco ER ULTERIORI INFORMAZIONI RIVOLGERSI A OR ANY INQUIRES OR NOTIFICATIONS PLEASE CONTACT US AT ALCO ALCO 13/G IA DEI IGLI 13/G IA DEI IGLI 20853 B , (MB) I IASSONO TALIA 20853 B , (MB) I IASSONO...
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Focus Film Distance (FFD - SID) settings is shown on the front panel. Versions: Versione standard R302/A + RO 333 R302/A DHHS + RO 333 Standard version Description MTR302/A - R302F/A - R302L/A DHHS MANUALE ISTRUZIONI / INSTRUCTION MANUAL...
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Version with Laser, Potter Bucky centering with power supply. Test effettuati al 100% su tutti collimatori DHHS Test performed on all collimators in 100%. Fig. R302F/A Fig. R302/A, R302L/A Description MTR302/A - R302F/A - R302L/A DHHS MANUALE ISTRUZIONI / INSTRUCTION MANUAL...
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Modello/Model R302/A Ralco 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.
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Modello/Model R302/A Ralco 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.
• 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.
- 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 •...
Modello/Model R302/A Ralco TUBE COMPATIBILITY N.B. I dati forniti qui di seguito sono in formato N.B. The following indications are edited in bilingue ciò per evitare discrepanze tra le both languages to avoid providing versioni. contradictory information in the two versions.
See Figure - Flange Mounting in this Chapter. • The collimator control tabs conform to EN 60601-1- par 28.4. Ralco recommends an appropriate force which ensures safe locking of the tabs min. 0.75 Nm (± 5 cNm)
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Modello/Model R302/A Ralco IF THE COLLIMATOR IS TO BE MOUNTED ON A ROTATING FLANGE . 0,50 . 0.75 A TIGHTENING FORCE BETWEEN MIN NM AND MAX • Check to see that 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.
Modello/Model R302/A Ralco ELECTRICAL CONNECTION HE WIRING DIAGRAM INCLUDED IN THIS CHAPTER REFERS TO THE STANDARD PRODUCT T 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 Supply and signals to the collimator must be to 2007/47/CE standards.
Modello/Model R302/A Ralco GC-L CHEDA Connectors 1. 20-30 V AC or 12-45 V DC J2 - Supply and Outputs 2. 20-30 V AC or 0 V DC 3. +5 V Fan 4. GND Fan 5. +5 V Laser 6. GND Laser 7.
Modello/Model R302/A Ralco OFF: fan is operated by microcontroller according to settings made with JP5. JP3 - Fan Power Supply ON: Fan is always supplied OFF: Laser is microcontroller operated. JP4 - Laser Power Supply ON: Laser is always supplied OFF: fan operates when the Led is ON.
Modello/Model R302/A Ralco CALIBRATION HE FOLLOWING PROCEDURES REQUIRE THAT X RADIATION BE PRODUCED AKE ADEQUATE PRECAUTIONS TO MAKE CERTAIN THAT NO PART OF THE HUMAN BODY IS EXPOSED TO X RADIATION DIRECT OR INDIRECT , X- ENTERING • Place a 35x43 cm. (14x17") cassette on the table top or other flat, horizontal surface.
Modello/Model R302/A Ralco Collimator to Focal Spot Alignment (Primary Shutter Cut-Off) Inspect the four images of the four collimator shutters which form the edges of the x-ray field. A definitely indistinct edge indicates that the primary shutter, close to the focal spot, is the one forming the line, rather than the outermost shutter.
Modello/Model R302/A Ralco • Use screw B to adjust transversally. • When calibration is terminated, lock the screws A. See the Figure that follows. ERTICAL LIGNMENT DO NOT TOUCH THE DISSIPATOR WITH YOUR HANDS IT COULD BE HOT AND CAUSE SEVERE BURNS •...
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Modello/Model R302/A Ralco COVER REMOVAL (1). VVITARE I QUATTRO GRANI IGHTEN THE FOUR ALEN PER FACILITARE LA SCREWS TO ALLOW RIMOZIONE DELLA REMOVAL OF THE COVER COPERTURA (2). OGLIERE LE DUE MANOPOLE EMOVE THE FRONT PANEL DAL PANNELLO FRONTALE BY UNSCREWING THE TWO...
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Modello/Model R302/A Ralco (4). COLLEGARE IL ISCONNECT THE CONNETTORE CONNECTOR (5). ELLE VERSIONI DI COLLIMATORE CON METRO N COLLIMATORS WITH TOGLIERE IL FERMO MEASURING TAPES REMOVE ALLARGANDOLO DALLA THE TAPE STOP BY LIFTING IT BANDELLA E SFILANDOLO OFF WITH A SCREW DRIVER...
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Modello/Model R302/A Ralco (7). OGLIERE IL COPERCHIO EMOVE THE REAR COVER POSTERIORE SVITANDO LE BY UNSCREWING THE THREE VITI SCREWS (8). PPOGGIARE IL LACE THE COLLIMATOR COLLIMATORE SULLA PARTE LOWER SIDE DOWN AND POSTERIORE LEGGERMENTE SLIGHTLY RAISE SOLLEVATO E SFILARE LA...
Modello/Model R302/A Ralco CCESS TO OLLIMATOR OMPONENTS Laser ER ACCEDERE AL LASER SMONTARE LE ACCESS TO THE LASER BY REMOVING THE TWO MANOPOLE E O IL PANNELLO ANTERIORE E KNOBS AND OR THE FRONT PANEL DEPENDING ON SECONDO DEL MODELLO DI COLLIMATORE...
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Modello/Model R302/A Ralco Use of the retactable tape measure in collimators with this feature: The type of tape measure used is a standard tape mounted on a radiological unit. The tape starts with values that correspond to the focus/collimator lower edge distance; maximum radiological measurement with the tape is 2 m max even though, for purely mechanical reasons, maximum tape extension is 3 m max.
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Modello/Model R302/A Ralco Longitudinal Movement ER ACCEDERE ALLO SPOSTAMENTO ACCESS THE LOGITUDINAL ADJUSTMENT PARTS LONGITUDINALE RIMUOVERE LO SPORTELLO BY REMOVING THE LATERAL PLATE LATERALE MTR302/A - R302F/A - R302L/A DHHS MANUALE ISTRUZIONI / INSTRUCTION MANUAL...
Modello/Model R302/A Ralco ADJUSTMENTS IELD NDICATION DJUSTMENT EN60601-1-3- par. 29.201.8 Regulations state that collimators must indicate the size of the X-Ray field at the FFD (SID) in use to within 2% of that FFD (SID). Shutter Dial Adjustment • Rotate the two control knobs to completely close both sets of shutters. Use the field light to check that the shutters are in fact closed.
Modello/Model R302/A Ralco • If a shutter control is too tight, loosen one of the two screws “A” on the U bolt that frictions the shaft - see the Figure. • Before replacing the knobs, close both shutters and mount/fix the knobs so that the field index is set at “0”...
Modello/Model R302/A Ralco CLOSED Stop Long and Cross Fig. Closed Stop Shutters • Loosen the Allen screw placed on the side of the stop. See Fig. 2 • Use the knob to close the shutters. Take care not to apply excessive force to check that the shutters touch.
Modello/Model R302/A Ralco Adjustment Procedures • Remove the part of the cover to access the point of adjustment. See Collimator C OVER EMOVAL • The line is to fall on a perpendicular corss-line on the antidust plastic panel near the collimator con- trols.
Modello/Model R302/A Ralco COMPLIANCE VERIFICATION INIMUM ILTRATION EQUIREMENT To indicate compliance with 21 CFR, sub-chapter J, part 1020 of Performance Standard it is necessary for the assembler to perform a series of tests. Description of test methods are illustrated in this chapter but factors, such as experience, availability of equipment and tolerance on compliance are referred directly to the Safety Standards covering Electromedical equipment.
Modello/Model R302/A Ralco Type 1100 Aluminium Alloy (as given in " ALUMINUM STANDARDS AND DATA" verification of compliance). Visual Determination of Half-Value Layer (hvl) The above HVL requirements can be met if it is demonstrated that the aluminium equivalent in...
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Modello/Model R302/A Ralco (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) Select a tube potential of 100 kVp and appropriate mA and seconds, with no added filtration in the beam make an exposure and record the reading.
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Modello/Model R302/A Ralco b) Place the Focus of the X-Ray tube at 100 cm. from the table top were the light field as been projected. Open the collimator's shutters to assure that each quadrant of the light field is larger than the measuring area of the photometer.
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Modello/Model R302/A Ralco YMBOLS Descrizione Description Rif. IEC 417-iec Corrente Alternata 01-14 Alternating Current 417-iec Corrente Continua%> 01-18 Direct Current 5031 Corrente Continue e 417-iec Both Direct and Alternating 01-19 Alternata 5033 Current 417-iec Terra di Protezione 01-20 Protective Earth...
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Modello/Model R302/A Ralco Descrizione Description Rif. IEC Parte Applicata di Tipo B 02-02 601-i-iec Type B Applied Part Attenzione Radiazione Laser Caution: Laser Radiation 60825-1 Dispositivo Sensibile Electrostatic Sensitive all’Energia Elettrostatica Device Dispositivo Impostazione Cassette Size Sensing Dimensione Cassetta Device Dispositivo che Richiede un attch.
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RF emissions Class [A] CISPR 11 This R302/A is suitable for use in all Harmonic emissions establishments other than domestic and [Not applicable] IEC 61000-3-2 those directly connected to the low voltage...
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Modello/Model R302/A Ralco Electromagnetic Immunity for All Equipment and Systems R302/A OLLIMATOR IS INTENDED FOR USE IN THE ELECTROMAGNETIC ENVIRONMENMT SPECIFIED BELOW HE CUSTOMER OR THE USER SHOULD ASSURE THAT IT IS USED IN SUCH AN ENVIRONMENT Immunity IEC 60601 Test...
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Electromagnetic Level ce Level 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.
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Modello/Model R302/A Ralco Table 2: 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...
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Ralco Recommended Separation Distances for Non-Life Supporting Equipment Table 3: Collimator R302/A is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the collimator can help prevent electromagnetic interference by...
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Modello/Model R302/A Ralco OPERATION INSTRUCTIONS IGHT IELD ETTING • Set the field dimensions at 100 cm FFD SID by rotating the knobs and, with the knob index, follow the tags of the scale. • Do not force the knobs. • Activate the light field by pressing the related pusbutton on the collimator.
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Modello/Model R302/A Ralco La tabella sul pannello frontale consente di The table provides the readout of the ricavare il numero da impostare con l’indice numbers which must be set with the knobs. manopole. Il numero da impostare si ottiene The exact number to be set is obtained by...
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The use of a faulty collimator might impair the safety of the operator and patient. Before returning the collimator to Ralco for repair, please make sure that the fault is not caused by one of the problems listed below. If the indications provided fail to solve your fault, please make sure that you obtain a Return number (RMA) from Ralco for the collimator.
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Modello/Model R302/A Ralco SUBSTITUTIONS Substitution of the Led • Disconnect supply. • Remove the cover - See Chapter - C OVER EMOVAL • Remove the Led protection heatsink. • Unsolder two wires. • Unscrew two fixing screws. • Remove the faulty Led.
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Modello/Model R302/A Ralco UBSTITUTION OF THE IRROR • Remove the collimator cover, front panel and rear cover, - See Chapter OVER REMOVAL • Remove the collimator lateral pro- tection walls. • Remove the mirror shaft stop on the left side of the collimator.
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Modello/Model R302/A Ralco • 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.
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Modello/Model R302/A Ralco • Substitute the mirror and re-mount in reversed order. Substitutions MTR302/A - R302F/A - R302L/A DHHS MANUALE ISTRUZIONI / INSTRUCTION MANUAL...
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Modello/Model R302/A Ralco R 302L/A ABEL ABEL ABEL ABEL ABEL Spare Parts MTR302/A - R302F/A - R302L/A DHHS MANUALE ISTRUZIONI / INSTRUCTION MANUAL...
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Modello/Model R302/A Ralco R302L/A DHHS ABEL ABEL ABEL ABEL ABEL Spare Parts MTR302/A - R302F/A - R302L/A DHHS MANUALE ISTRUZIONI / INSTRUCTION MANUAL...
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ECOMMENDED AINTENANCE ROGRAMME Ralco suggests a yearly servicing programme. However shorter intervals are advisable when the collimator is subject to heavy workloads. • Re-calibration of the collimator will be necessary whenever the x-ray tube is changed or at each substitution of the lamp used to simulate the light field.
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Modello/Model R302/A Ralco • If the collimator assembles a Lexan panel, check the Lexan panel and substitute it if neces- sary. • Clean the collimator with a soft cloth paying particular attention to the Lexan window. Do not use abrasive or inflammable cleaning products.
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Ralco will possibly resolve the problem by either providing directions, and/or field service or by sending replacement parts. In the event the collimator needs to be repaired by at Ralco, customer service wil immediately provide the customer with a RMA (Return Merchandise Authorization) number as your consent to the return and provide all necessary additinal information.
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• To use of unoriginal spare parts and accessories. In-warranty spares will be available only upon return to Ralco, at the customer's expense, of the parts considered to be faulty to allow assess the cause of the fault.
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Directive 2007/47/CE para.10 -Legislative Decree n° 46 para.10 Ralco shall not be held responsible when instructions provided in the present manual are not complied with. Ralco shall not be held responsible if the collimator relates to one or several of the following instances: •...
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Modello/Model R302/A Ralco PERSONALIZATIONS Il collimatore R302/A è stato personalizzato Collimator R302/A has been customized nei seguenti modelli. Le specifiche relative a in the following models. The un dato modello saranno fornite al cliente specifications related to a given model will...
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MInistry of Health and to the Sanità e al Costruttore. Manufacturer. Il presente modulo serve per segnalare alla ralco srl tali The present form is provided to report to Ralco srl eventualità con spedizione del modulo a carico del post-free, accidents of the type stated in the destinatario.
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