Model SR-130 Portable X-Ray System Installation/Operation Manual (Revision 6 UL, S/N 540...) Source-Ray;Tac... 167 Keyland Ct., Bohemia, NY £1716 (631) 244-8200, Fax (631) 244-7464Section 1 SR-130 (rev 6 w) PAGE SECTION I GENERAL INFORMATION 1a Introduction 1 12 Description 1 13 Important Notice 1 14 Compliance Notice 2 15 Safety Standards 2 16 Electrical Specifications 3 | 17 X-Ray Tube Characteristics 4 | 18 Mechanical Specifications 6 Ir INSTALLATION AND CALIBRATION 24 Interconnections 10 22 Calibration Set-up i / 23 Tube Potential (kVp) it 24 Beam Current (mA) 12 25 Exposure Time 2 | 2.6 Beam Alignment 13 | 27 Yoke Adjustment 4 ur OPERATION 3A Controls and Indicators 15 3.2 Operating Procedure (Control/Generator) 2 33 Operating Procedures (Stand Assy.) 24 Iv THEORY OF OPERATION 41 ‘System Overview 27 42 Generator Assembly 27 4.3 ‘Contro! / Power Inverter Assembly 28SR~130 (rev 6 ur) v 54 5.2 5.3 5.4 5.4 LIST.OF FIGURES FIGURE at 12 13 21 22 3.1 3.2 3.3 34 | 35 3.6 37 LIST OF TABLES TABLE 34 5A 5.2 MAINTENANCE Introduction Recommended Intervals Ordering Information Maintenance Procedure Cleaning Procedure DESCRIPTION System Dimensions Rating Chart, X-Ray Tube Cooling Curve, Tube Head Assy. Yoke Adjustment Pivot Adjustment Control Panel Descriptions Control Module (Rear View) ‘System (Side View) Generator Assembly (Bottom View) Leg Assembly ‘Transport Mode Possible Pinch Point DESCRIPTION Technique Charts Maintenance Checklist Displayed Fault Conditions DESCRIPTION Schematic, Top Level SystemSR-130 (revs) LIST_OF SYMBOLS [Symbol] DESCRIPTION 0 Exposure Switch For Human Use Protective Earth Attention, Consult Accompanying Documents k ® AN A Pinch Point, Keep Hands Clear11 12 13 SR-130 (reve ui) Section 1 GENERAL INFORMATION IntRopuctIon This manual is divided into five sections and contains the following information: Section I describes general information, Section II contains installation and calibration procedures. Section III contains operating procedures and technique guides, Section IV discusses theory of operation and Section V contains maintenance procedures and recommended intervals. Description The mode! SR-130 x-ray system is designed and manufactured by Source-Ray, Inc. It provides a high quality radiographic capability in a portable format. It is @ component system consisting of the following items: Model: ‘SR-130-G X-Ray Generator/ Tube Housing Model: ‘SR-130-C X-Ray Control Module Model: ‘SR-130-S Portable X-Ray Stand Important Notice ‘The equipment manufactured by Source-Ray, Inc. and covered in this manual will function properly when operated, maintained, and repaired in accordance with the instructions in this manual. Source-Ray, Inc. does not assume responsibilty for any malfunctioning of this equipment resulting from improper operation, maintenance, repair, or modification of its components. This equipment can be hazardous to both patient and operator unless established safe exposure factors are observed. Source-Ray, Inc. disclaims all responsibility from any injury resulting from improper application of this equipment.SR-130 (revo) : Section 4 14 15 16 (ComPLIANCE NOTICE The Source-Ray model SR-130 you have purchased has been designed, manufactured and calibrated to comply with the governing Federal Regulations 21 CFR Subchapter J. The maintenance schedules included are crucial to the continued reliability of this equipment with respect to regulatory compliance. Class I - Intermittent Mode ‘SR-130 System consisting of: X-Ray Generator: Model SR-130-G Control Module: Mode! SR-130-C Tube Current: 15 / 30 mA Tube Voltage: 40 - 100 kVp Exposure Time: .01 - 4.0 s ‘Sarety STanpaRDs The Source-Ray equipment you have purchased has been designed, manufactured, and calibrated to meet the following safety standards: In Accordance With q AX us CAN/CSA C22.2 No. 601.1 With Respect To Electric Shock ee KAA | Petttedentsltarmce | Ul sot ec oaar 27 8 The Model SR-130 is designed to comply with IEC 60601-1-2. Evectricat SPECIFICATIONS MILLIAMPERES Milliamperes will not deviate from the selected value by more than +/- 5% within the operating line voltage range and within the specified tange of line voltage regulation. Measurements made with an Inovision mAs meter model 35035 or equivalent at 1.0 second. KILOVOLTS Kilovoltage will not deviate from the selected value by more than +/- 5% of full scale Measurements made with an Unfors Xi Mult-O-meter or equivalent at 0.1 seconds.SR-130 (rev 6 UL) 1.6 Continued: “TIMER: Exposure time will not deviate from the selected value more than +/- 2%, plus +/-Sms. within a range of 0.01 - 4.0 seconds. Measurements made with an Unfors Mult-O-meter Mode! Xi or equivalent. MAS MAS will not deviate from the selected value more than +/- 15% or .5 mAs which ever is greater within a range of .15- 100 mAs. Measurements made with an Inavision mAs meter mode! 35035 or equivalent. MAXIMUM RATING 30 mA at 100 kVp DC LINE VOLTAGE REGULATION 5% maximum as measured at the x-ray control panel at maximum rated output REQUIRED APPARENT RESISTANCE OF SUPPLY MAINS 115 ~ - 0,259 MAXIMUM LINE CURRENT (30 mA at 100 kVp). Momentary: 45 A, Long Term: 4 A at 115 ~ (AC) Measurements made with a FLUKE 179 True RMS DVM and a FLUKE Y1801 clamp-on current probe adaptor. LINE VOLTAGE RANGE 115 w (103.5 - 126.5 AC) 50/60 Hz All portable sources will be adequate provided they meet the requirements of the system input ratings, LEI ER 3.0 KW, Constant potential derived from a high frequency inverter system, Regulated for both kVp and mA, MINIMUM PERMANENT FILTRATION 3.6 mm of aluminum equivalent at 100 kVp1.6 17 SR-130 (reve uy) ‘ Section 1 Continued: REFERENCE CURRENT TIME PRODUCT (Power On Defaults) Beam Current: 30 mA ‘Tube Potential: 80 kVp Exposure Time: 0.1 Sec. LEAKAGE TECHNIQUE FACTORS Testing is performed at 100 kVp and 30 mA, 2 sec exposures every 1 minute. COOLING CURVES ‘Automatic inhibit circuits provide a delay between exposures proportional to the exposure time. This delay is sufficient to allow proper tube cooling. The delay between exposures varies between 10 seconds and 120 seconds depending on the exposure time ENVIRONMENTAL Operating Temperature: 40 - 90 Deg. F, / 5 - 32 Deg. C Storage Temperature: 30 - 110 Deg. F. / -1 - 43 Deg. C X-ray Tuse CHARACTERISTICS X Manual Operation Mode ' » Calibration Mode 2) Manual Operation This is the default mode of operation, which normally appears immediately | after the Power On Self Test (POST). To adjust KV output, use the kV Up and kV Down keys 3) Calibration Mode To enter the Calibration Mode, turn the unit ON and press “KV Up” “Reset”, and “Time Up” simultaneously for approximately 2 seconds during the POST condition and release. Successful entrance into the calibration mode will result in the following displays - kVp: 888, mAs: 0130 and Time: 2.00. These displays will hold for approximately 2 seconds. The displays will then change to; kVp: 40, mAs: 0 = 255 and Time: 0.25, indicating that the system is ready to calibrate the 40 kp range at 30 mA and 0.25 seconds a. Make an exposure and measure the actual kVp. b. To increase or decrease the kV, Press kV up or down. Each activation of the button increases or decreases the kV by approximately 0.5 KV. The number displayed in the mAs window represents a digital code for kV reference ands increased or decreased by one with each activation of the KV switches, ©. When the calibration is completed for the 40 kVp range, depress the "mA Select” to move to the next kVp range (50). . Repeat steps a — c for the 60, 70, 80, 90 and 100 kVp ranges. . Depressing the mA Select” button will loop back to the 40-KVp range at 15 MA. Repeat steps a — c for the remaining ranges. f. When all calibration ranges are completed, re-cycle the main power switch } to exit the calibration mode and return to normal operation. poSR-130 (ev 6 U1 ‘ Section 3 2.4 Beam CURRENT (mA) 25 ‘The KVp meter should be set to display 80 kVp, 30 mA. The squareness of the wave-shape (leading edge) can be adjusted by the service man as follows: 1) Collimate the X-Ray beam to size of the filter pack on the kVp meter. Set Channel 2 of the oscilloscope to view the ma wave-shapes via TP3 on the control board and step away from the unit, Set the Control Module for 80kVp, 30mA for a 1 second exposure. Make an exposure and view the mA wave-shape. Adjust R78 on the control board counter-clackwise to raise the leading edge of the mA waveform, or clockwise to lower the leading edge of the ma waveform as necessary. 2) Take another test exposure and observe the reading on the MAS meter. The reading should be 30mAs +/- 5%. If adjustment is required, turn R83 on the control board clockwise to raise the mA and counter-clockwise to lower the mA. Exposure Time Measure the exposure time on the kVp meter and confirm timer accuracy as indicated on checklist.SR-130 (rev 6 ut) Section 3 2.6 Beam ALIGNMENT Tighten yoke block to prevent movement during alignment. Rotate Collimator so ‘that the knobs are facing front and tighten lock. Remove the collimator outer shroud by removing the 4 screws securing the shroud to the collimator. Place the phosphor screen in the beam at 40" and collimate field just to the outside edge of the middle rectangle. Place Beam Alignment Tool in center of field (center dot at intersection of center lines) and adjust beam so that shadow of upper dot covers lower dot. Readjust borders if necessary. Set the Control Module to 80kV, 15mA for about 2 seconds. Take an exposure while observing the X-Ray field through the lead glass window of the test cabinet. Note the difference observed between the light field and the X-Ray field for further adjustment. If the centers are too far out of alignment, adjustment of Collimator light field is necessary. To adjust the horizontal position of the light field, rotate the collimator 180 degrees to gain access to the mirror adjustment hardware. Loosen the locking screws sufficiently so as to allow the turning of the adjuster cam. Lock the fixing screw and cam after adjusting the mirror position, To adjust the vertical position of the light field, remove the lamp heat dissipator taking care to avoid being burned, as the dissipator can be very hot. Loosen the two lamp support fixing sorews and using the hexagonal screw on the side of the lamp, adjust the lamp in the desired direction. Tighten the four screws fixing the lamp support. Finally, to adjust the brightness at the edges of the light field, loosen the screws fixing the screen to the lamp holder, and using an Allen screws, move the screen to obtain the desired adjustment. Tighten the screen fixing screws.SR-130 (revs) : Section 3 27 Yoxe Adjustment To set the tension on the Yoke, loosen the pivot set screw (A), (refer to Figure 2.1), Using a 5/16 Allen wrench, tighten or loosen the yoke pivot bolt (B) to the desired tightness. Caution - Be sure to re-tighten the yoke pivot set screw (A) to lock in the adjustment prior to tension verification, Figure 2.1 To set the tension on the Generator Assembly pivot (refer to Figure 2.2). Adjust the pivot adjustment screw (A) on either side of the Generator Assembly using a 7/64” Allen wrench until the desired tension is achieved.SR-=130 (reve ur) Section 3 UNIT OPERATION 3.1 Controts AND Inptcators DESCRIPTION EUNCTION 1) POWER ON SWITCH/ Rocker type switch that controls the primary CIRCUIT BREAKER (25.A) power into the system. Operating ‘the switch turns the unit on, Power should not be turned on until the generator is ready for use. Circuit breaker will trip if excess current is drawn. 2) KVP METER A digital LED meter that indicates the selected kVp in 1-kVp increments. 3) MAS METER A digital LED meter that indicates the ‘computed MAS prior to exposure. 4) TIMER METER A digital LED meter that indicates the preset ‘exposure time from 0.01 to 4 seconds, 5) KVP ADJUST Two momentary switches that adjust the kVp from 40 to 100 kVp in 1 kVp increments, 6) MA SELECTOR Momentary switches that toggles selection of either the 15 or the 30 mA station, 7) TIMER ADJUST Two momentary switches that adjust the exposure time from 0.01 to 4 seconds. 8) READY INDICATOR Tlluminates when unit is ready for operation, Automatically prevents excessive operation by means of a time delay circuit. NOTE: Internal fuses provide protection for auxiliary DC circuits. Replacement to be done by Authorized Source-Ray Personnel only.SR-130 (rev 6 ur) 3.1 Continued: DESCRIPTION 9) X-RAY ON INDICATOR 10) FAULT INDICATOR | 11) RESET BUTTON | 12) OPERATE SWITCH Section 3 FUNCTION Illuminates when exposure switch is depressed to indicate the timed interval of X-ray output. In addition, an audio tone is generated at the same time. A lamp that illuminates to indicate that a fault condition has occurred. Refer to table 5.2 for a description of fault conditions. Clears and resets the front panel controls in the event of a fault condition (reference Table 5.2) A two-position switch that controls the x-ray output. The first position is for prep (ready light goes out and comes back on when unit is prepped), the second position is for x-ray (x-ray light comes on while x-rays are being Produced). Premature release of the exposure switch will terminate the exposure and light the fault lamp. Depress the RESET button to clear the fault and Reset the timer.SR-130 (Rev 6 UL) Section 3 3.1 Continued: DESCRIPTION : EUNCTION A) INTERCONNECT CONNECTOR — Connects.Control Module to Generator Assembly. B) A.C. INPUT CONNECTOR CAUTION Apply only the voltage specified on the nameplate. C) INTERCONNECT CABLE Connects the Generator Assy. To the | Control Module. D) EXPOSURE SW CONNECTOR — Connects the exposure switch to the Control | cee E) YOKE ASSEMBLY Controls position of the head assembly. Allows pivoting about two axis’s, maintains | position with friction locks. F) BOOM ARM Controls height adjustment of head assembly. | G) SKIN GUARDS Limits Source to Skin Distance (SSD). WARNING: Do not use as handles. H) BOOM ARM RELEASE Releases “Piston Lock” allowing movement of the boom arm, 1) SKID BARS Functions as handles during transport and rest blocks in the storage 3) WHEEL BRAKE Manual lever. Prevents unit from rolling when positioned on an incline or in the storage mode. | K) LEG RELEASE Spring loaded slide bracket. Allows front leg to be folded into the storage position | L) COLLIMATOR LAMP Depressing the button activates the lamp which automatically extinguished after aprox 15 seconds to extend bulb life.SR-130 evs) : Section 3 3.1 Continued: DESCRIPTION FUNCTION | M) COLLIMATOR INPUT Connects the collimator to the 24 VDC power supply via the Generator Assembly. i N) MA TEST JACK Test point for mA during the calibration mode. Figure 3.4 Contro! Panel DescriptionsSR-130 (rev ul) Section 3 Figure 3.2 Controt Chassis (Rear View)SR-130 (Rev 6 ur) Section 3 Figure 3.3 System (Side View)SR-130 (rev 6 uL) Section 3 Note: Item G is askin guard and is ‘Not intended as a handle Do Not Lift from this Point Figure 3.4 Generator Assembly (Bottom View) Figure 3.5 Leg AssemblySR-130 (rev ur) i Section 3 3.2 OpeRATING Procepures: Control/Generator 2) 3) 4) 5) 6) 8) 9) 10) CAUTION AN Do not attempt to connect or disconnect any interconnect cables without disconnecting the mains supply first. Operate the "Power On” switch to turn the primary power on. Position the generator at the desired distance from the film cassette (Ref. Table 3.1 for technique guides). The model R72/32-ET collimator has a built-in tape measure to determine SID (source to image distance) accurately. ‘Activate the “Collimator Lamp” by depressing the push-button located on the front of the collimator. The collimator lamp will automatically extinguish after a period of approximately 15 seconds to extend bulb life. Position the generator so that the collimator light beam is centered on the film cassette, Collimate the light field to the area of interest by means of the shutter adjust knobs. Select the desired kVp by means of the kVp adjust switches Select the desired mA station by means of the mA selector switches Adjust the “Exposure Time” Control to the desired time interval by means of the Time selectors (7), The resultant mAs is displayed on the mAs meter. After the required warm up period, the “Ready” Indicator will illuminate, It will not be possible to operate the unit until this has occurred. If the unit has not been operated for a long period of time an additional 2-minute waiting period is recommended. While holding the “Remote Exposure Control”, step at least 6 feet to the rear or side of the x-ray generator.SR-130 (Rev 6 ui) Section 3 3.2 Continued: 11) Depress the “X-Ray Switch” to the first position (prep). The “Ready Light” will go off and come back on when the unit is.fully prepped. 12) Depress the “X-Ray Switch” to the second position for immediate exposure. An audio tone will sound in addition to the “X-Ray” indicator illuminating for the duration of the exposure. Releasing the “X-Ray” switch prior to the pre- selected time interval will terminate the exposure, light the “FAULT” Indicator and display a fault condition (Ref. Table 5.2). Notes: 1) Unless the x-ray generator is going to be immediately used again, the “Power ON” switch should be turned off. Leaving the unit turned on provides opportunity for an accidental operation. 2) If the unit is going to be operated again, an automatic inhibit circuit will allow the x-ray tube to cool in proportion to the exposure time to prevent damage to the x-ray tube from overheating. At the end of this cycle the “Ready” light will illuminate indicating an exposure can be made.SR-130 (Rev 6 UL) ; Section 3 3.3 OPERATING PROCEDURE: Mechanical Stand (Applies to additional stand when furnished) From Storage Position: 1) 2) 3) 4) 5) 6) 2 8) 9) 10) 11) 12) 13) 14) 15 Pull back on the spring loaded Safety Pin and hold, slide release block back and unfold the front leg to its operating position. Release the Safety Pin to its original position. Grab hold of the Skid Bars and stand the unit up. Release the Wheel Brakes and move the unit to the area of interest, Pull back and hold the Boom Arm Release Lever. While holding the Boom Arm Lever, raise the Generator/Collimator to the desired position. Position the Generator/Collimator Assy, (All movements are controlled by friction locks and will remain where set), From Working Position: Position Generator/Collimator Assy inline with the Boom Arm. NOTE: Skin guards must be positioned to straddle the front leg. Pull back and hold the Boom Arm Release Lever. Slowly move the Generator/Collimator Assy. To it's storage position. Release Boom Arm Release Lever. Lock both Wheel Brakes. Pull back the unit and rest the unit down on the Skid Bars. Pull back on the spring loaded Safety Pin and hold. Slide the Release Block back and fold the front leg to its storage position. Release the Safety Pin to its original position.SR-130 (rev 6 vw) Section 3 A Warning! Do not transport unit with the arm extended. Only transport unit with the arm in the park position. Area of Magnification Figure 3.6 Figure 3.7 Possible Pinch PointSR-130 (rev 6 UL) TABLE 3.4 Tecuntove Cuart Film Screen: Regular 400 speed. Grids are 8:1 (multiply technique x 4) ‘Chest (AP) ‘Average male 60 ‘Average female 607 (Chest Lateral ‘Average male a0" Average female 40" Use grid for all chests, with exception of If patient is breathing rapidly you may wish to shoot without. ‘Apdomen ‘Average a Powis ‘Smal a" ‘Average 40" Large 40" Hip ‘Small a ‘Average 40" Large 40" Femur Average: a Knee ‘Average, x ow 1 pationt is unable to stralghton knee completely increase kVp to 6211 Tibia/ibula ‘Average x a ‘Ankle (AP Average a Foot ‘AP Average a0" Lat Average 40" ‘Shoulder ‘Average a Humerus ‘Average we Elbow ‘Average a Forearm: ‘Average a Wist ‘Average: a Hand ‘Average 40" T-Spine AP. ‘Average 40" T-Soine Lat ‘Average 40" T-Spine AP ‘Average ao L-Spine Lat ‘Average 40" C-Spine AP ‘Average 0" ‘C-Spine Lat ‘Average a Swimmers Average ae"SR-130 (rev 6 UL) Section 4 FF OPERA’ 41 System Overview The Model SR-130-C incorporates three major electrical sub-assemblies. The generator Assembly consists of the high voltage circuitry, the x-ray tube and the collimator (further discussed in section 4.2). The Control Assembly houses all of the electronics, microprocessor, high frequency generating circuits and the front Pane! controls (further discussed in section 4.3), The Inverter Assembly is part of the Control Assembly, but is discussed in detail in section 4.3, Generator AssemBLy ‘The X-Ray Generator Assembly is made up of both the High Frequency X-Ray Head and the Collimator, which are both interconnected with the Control / Power Inverter assembly via connector J1 (Ref. Dwg 100022). The voltage used to generate the high voltage at the high frequency head enters the assembly at pins A & B of connector J1. The voltage is approximately 650 VPP at an approximate 30 kHz square wave, for a 100-kVp output. The filament voltage enters at pins F3,0:1 The field size at 900m, 100cm and 180 cm Focus-Film Distances (FFD) (SID) is read on the collimator panel. INSTRUCTIONS MANUAL MTR72/032/DHHS - page B—3Ratleo.. C) SPECIFICATIONS: MODEL R72 Inherent filtration Al. equivalent x-ray beam = 75 kV EN 60601-1-3 par. 29.201.6 / 29.201.7 Min. 2.0.mm. Al. Limitation of Extra focal radiation: focus distance 80 mm , FFD (SID) 100 cm EN 60601-1-3 par.29.202.3 < 450 mm Xray field selection : 400 cm FFD (SID) EN 60601-1-3 par. 29,2024 Min: 00 x 00 mm (# 1% D.F.F.) Max. 480 x 480 mm (+ 1% D.F.F.) © Light field indicator: > 160 Ix luminosity at 100 cm from the focus: EN 60601-1-3 par. 29.202.7. © Light field indicator : oat ‘edge contrast setting 350x350 mm at 1000 mm FFD EN 60601-1-3 par, 29.202.7 + X-ray field indication precision <2% DPF. settings on an index scale EN 60601-1-3 par. 29,202.8 + Light field indicator precision <1%D Light field/x-ray field correspondence: EN 60601-1-3 par. 29.202.9 ‘* FOD (SID) : (optional) <2% DEF. Precision of measurement with retractable tape EN 60601-1-3 par. 29.203.2 ‘+ Leakage radiation: <50 mRih x-ray beam = 125 kVp /4 mA EN 60601-1-3 par. 29.204.3 * Lamp power supply: 24V DCIAC Standard lamp 24V 100 W OSRAM HLX 64638 | 50/60 Hz 6.58 © Fuse, lamp 4 Amp delayed certified © Weight: 3.6 kg Classification 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 seepage : “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 anaesthetic mixtures containing air o oxygen of nitrous oxidé Operation conditions: Equipment for continuous operation at intermittent loads .- Soe Operation Instructions on page I—1. INSTRUCTIONS MANUAL MTR72/032/DHHS - page C—1Ral C0. MODEL R72 ‘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 Standards relating to specified equipment. Operation environment: * Ambient temperature = from 10°C to 40°C ‘Relative Humidity = from 30% to 75% + Atm. Press. = from 700 to 1080 hPa Included with the collimator : * Instructions Manual * Retractable measuring tape shows the Focus Film Distance (FFD - SID). * RO 195- Tube port mounting flange, rotating, + 45° without stop, 14mm thickness. (R72/032A DHHS), * RO 196 - Tube port mounting flange, rotating, + 90° with stop at 0°, 14mm thickness. (R72/0328 DHHS). + RO 198: Focus/skin spacer to keep the patient at 30 cm. Optional item: * RO 199 - tube port mounting flange, rotating +90°, stop at 0°, thickness 10mm. Warning AVVISO| WARNING Uso del metro retraibile in collimatori| Use of the retractable tape measure In| dotati di questa funzione: collimators with this feature: Il metro adottato @ un metro standard |The type of tape measure adopted is a montato su apparecchiatura radiologica. In | standard tape mounted on a radiological unit. questa applicazione il metro parte con la | In this application the tape starts with values misurazione con un valore che corrisponde | that correspond to the focus/collimator lower alla _distanza fuoco/ bordo inferiore del| edge distance; maximum radiological collimatore; la __massima —_estensione | measurement with the tape is 2m max radiologica @ di 2m max anche se, per | even though, for purely mechanical reasons, ragioni meccaniche, il metro raggiunge 3 m | maximum tape extension is 3m max. The max, A fine lettura meccanica massima | indication of STOP is evident immediately viene riportata la scritta STOP. after the maximum mechanical value. re e/o forzare il nastro de! metro olire | Forcing and/or extending the tape beyond 2__quesia_misura__causa i sequenti point_with cause the following inconvenient; inconveniences: + rottura del nastro oppure ‘* Breakage of the tape or, * distorsione del nastro oppure Distortion of the tape or, + Vimpossibilita di fare rientrare il nastro | «Impossibility of retracting the tape into nel'alloggiamento perché é slata its lodging because the grip of the forzata la tenuta della molla sul nastro spring has been forced and hook-up creando una distorsione. is consequently distorted. NOTA: NON ESTENDERE IL NASTRO| NOTE: DO NOT EXTEND THE TAPE OLTRE Il NECESSARIO E IN OGNi CASO | BEYOND THE INDICATION OF STOP NON OLTRE LA SCRITTA STOP INSTRUCTIONS MANUAL MTR72/032/DHHS - page C—2Raleo.. MODEL R72 Symbols ‘SIMBOLI DESCRIZIONE [DESCRIPTION. NO. | RiF.CEl SYMBOLS we Corrente Aitemata/Alternating Current O14 ate 503 =. Corrente Continua/Direct current 01-48 st7aec — 134 we Corrente continue @ Alterata/Both direct and alternating |01-19 | fr7a° current 5033 © Terra di protezione/protective earth 01-20 |417e¢ i 5019 t Pid; polarita positiva/Plus; positive polarity 01-27 nett — Meno; polarité negativa/ Minus; negative polarity 01-28 |Atrec i 006 © i Entrata/ Input 36 |4t7+€0 i] fatal Input o1-36 [477 | Oo Uscita/ Output 01-37 [417-ec { | 6035 4 Controllo a distanza/Remote Control 01-38 aN Controllo manuale/Manual contro! 01-46 _|!S0 7000- © Controllo automatico/ Automatic control (closed loop) 01-86 fio T000- S Diaframma a iride aperto/ Iris diaphragm:open 01-69 |atrec | S Diaframma a iride: chiusof iris diaphragm: closed 01-70 |4ttaec 6 i Attenzione, consultare i documenti di 03-02 [1c 601-1 | Z t \ accompagnamento/ i Attention, consult accompanying documents 238 Filtro di radiazione oppure filtrazione / 04-51 | 4t74eC | ee Radiation filter ar filtration 5381 | ie Indicatore luminoso del campo di radiazione/ 4iT-€c | + Light indicator of the radiation field 04-54 [5384 o Dispositivo di limitazione fascio: aperto/ 04-55 |417-1ec fi Beam limiting device: open 5385 [ INSTRUCTIONS MANUAL MTR72/032/DHHS - page C—3Raleo. MODEL R72 | ‘SIMBOLY DESCRIZIONE [DESCRIPTION. No. | RiF.CEl ‘SYMBOLS Dispositivo di imitazione fascio: chiuso : 04-56 [417-66 Beam limiting device: closed £388 H Dispositivo di limitazione fascio con apertura separata|04-57 | 41746¢ | della lamelle. 9387 Beam limiting device with separate opening of the shutters 4 Dispositivo di limitazione fascio con chiusura separata|04-58 , |4176C della lamelle. 5388 Beam limiting device with separate closing of the shutters sk Apparecchio tipo B/type B unit 78-02-02 hs Attenzione radiazione Laser/Caution Laser Radiation 60825-1 Dispositivo sensibile all'energia elettrostaticalElectrostatic sensitive device g Dispositivo impostazione dimensione cassetta/ Cassette \ 4 {size setting | at LA) Dispositivo che richiede un corretto gmaltimento Device |atron.4 |2002/ REQUIRING PROPER DISPOSAL 96/CE — COMPATIBILITY WITH X-RAY TUBE HOUSING ASS! Compatibility is determined by the ability te comply met drawing on Figure 1 page R—1; that the tube housing assembly sinerent fitration of 1:mm. Al. equivalent and @ maximum radiation leal measured at one meter fram the source when ‘operating at its leakage technique factors (125 kvp at 4 mA). Source values (tube housing-collimator) must not be less than 3mm Al for filtration and Fust never exceed 100 mR/hr for radiation leakage INSTRUCTIONS MANUAL MTR72/032/DHHS - page C4Raleo.. MODEL R72 D) MOUNTING THE COLLIMATOR TO THE X-RAY TUBE: WARNING CAREFULLY FOLLOW THE MOUNTING INSTRUCTIONS AND MAKE SURE THAT THE! COLLIMATOR IS CORRECTLY ASSEMBLED. INCORRECT MOUNTING COULD BE DANGEROUS: IT COULD CAUSE THE COLLIMATOR TO FALL OR TO OPERATE INAGCURATELY 1. The outer face of the collimator mounting flange must be at 56mm (2.20") from the focal spot. Allowable tolerance is 1 mm. (0.039"). - see Figure 4 on page R—1 2. Select four countersink bolts of suitable thread (M6 ) and of such a length that they protrude through the flange and spacers far enough to engage at least 5 threads into the tube port face. Securely bolt the fiange to the tube port face. 3, Remove the cover by unscrewing the four M3_screws located on the lower side of the cover. 4, Unscrew the four mounting and centring adjustment Allen screws M6 until the four tongues are withdrawn from the collimator top opening; see Figure. 1 — page R—1. Note: when unscrewing the Allen screws that control the tabs do not use force exceeding 0,55 Nm. Unscrew with care so as not to damage the fixing tabs 5. Place the collimator on the flange. Tighten the four mounting screws equally until the collimator is held firmly on the flange (0,55Nm max), see Figure. 1 - page R—1. Collimator control tabs conform to EN 60601-1-par 28.4. IMPORTANT: make sure to tighten the M6 Allen screws securing the control tabs. g of the 4 Allen screws ensures secure mounting of the jator. Tightening force used must not exceed 0.50 Nm. 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. 6. Check to see that the distance from the collimator housing to the mounting flange is equal in all directions and that the collimator face is parallel to the axis of the table. 7. Repeat the alignment if necessary. INSTRUCTIONS MANUAL MTR72/032/DHHS - page D—1Raleo.. MODEL R72 E) ELECTRICAL POWER CONNECTION: CHECK ON THE COLLIMATOR LABEL THE VERSION SUPPLIED. WARNING ] COLLIMATOR SUPPLY IS NOT PROTECTED BY A FUSE. CHECK THAT THE COLLIMATOR IS PROTECTED BY AN EXTERNAL FUSE PRIOR TO CONNECTION, FUSE REQUIREMENTS: 4A DELAYED FOR THE 24v VERSION 8A DELAYED FOR THE 12V VERSION CABLES AND TERMINALS USED FOR THE INTERNAL CONNECTION OF THE COLLIMATOR MUST BE SUITABLE FOR OPERATION AT TEMPERATURES OF 70° C AND COLLIMATOR CURRENT ABSORPTION. Collimator supply must conform to MDD 93/42 Power supply connection: © Unscrew the 4 screws on the lower Portion of the cover; remove the cover. * Connect the the cables to the terminal board contacts +2Vcc (M3) and OV (M5) * Refer to the timer board diagrams on pages R—6, R-8, R—9, Connect the earth cable to the appropriate contact on the terminal board marked by the symbol: ‘* Remount the cover. WARNING INCORRECT POWER SUPPLY COULD DAMAGE THE ELECTRONIC TIMER ANDIOR THE LAMP. SUPPLY TO THE QUARTZ IODIDE LAMP AND TIMER MAY BE EITHER IN ALTERNATE CURRENT OR DIRECT CURRENT - IN THE LATTER CASE MAKE CERTAIN THE POLARITY IS RESPECTED. INSTRUCTIONS MANUAL MTR72/032/DHHS - page E—1Raleco.. MODEL R72 F) COLLIMATOR CALIBRATION: WARNING: THE FOLLOWING PROCEDURES REQUIRE THAT X-RADIATION BE PRODUCED. TAKE ADEQUATE PRECAUTIONS TO SEE THAT NO PART OF THE HUMAN BODY IS EXPOSED TO X-RADIATION, DIRECT OR INDIRECT. Centring the x-ray field with the light field Place a 35x43 om. (14x17") cassette on the table top or other flat, horizontal surface and position the x-ray tube/collimator assembly with the focal spot at 1 meter (40") above and with the x-ray beam perpendicular to the cassette surface. Do not use ‘equipment scales for reference, but measure the distance from focal spot to cassette surface. Note: if one meter FFD (SID) cannot be obtained, use the obtainable FFD (SID) that is closest to ‘one meter and calculate the measurement tolerances as the appropriate percentages of the distance. If the xray beam cannot be oriented vertically, then make provision by using clamps, masking tape, etc. as required to place the test objects and image receptor at the specified FFD (SID) and perpendicular relative to the x-ray beam as described in the following procedures. Use the collimator light to centre the cassette in the field. + Mark the location of the cassette with masking tape or other means so that it may be removed and replaced in the same position. ‘* Place white paper on top of the cassette to provide maximum contrast for the light field. CO © Set the collimator to provide a field size of 30x30 cm. (12x12") 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 CO that the inner coin is lighted as much as possible and the outer coin is lighted as little as possible. ‘© The tangent points will define the edges of the light field ‘+ Place the extra two coins: one in the lower left comer, to provide the means for adjusting the film, and the other in the centre of the light field. + To find the centre draw two diagonals across the light field; the meeting point will determine the centre. INSTRUCTIONS MANUAL MTR72/032/DHHS - page F—1Raleo.. MODEL R72 * Set the technique factors at the xray generator to produce a density of about 1 (about 50 kVp, 5 mAs). * Make an exposure. Remove the cassette and process the film. Use the test film to check the alignments: described in the following paragraphs. 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, To correct the condition use the four mounting/centring adjustment screws to shift the collimator in the direction of the indistinct line. Repeat the test film exposure after making the adjustment. NOTE: The heel effect will cause the field toward the cathode to be slighily less sharp than on the other three sides . This is normal and cannot be corrected by adjustment. In addition, an x-ray tube of 12 ° or less target angie will produce an asymmetrically shaped field when a large field size is used at short FFD (SID), because of anode cut-off effect. This is normal and may not be corrected by adjustment. Light field to x-ray Field Alignment. EN 60601-1-3 par 29.202.9 - CFR 21 Sub-chapter J 1020.31(d)(2) Misalignment of the light field to the x-ray field in either the X (cross table) or Y (long table) direction must not exceed 2% of the FFD. In this case, it would be less than 20 mm (0.78"). If the test flm shows that the light field (shown by the shadows of the markers) matches the x- ray field (shown by the shadow of the collimator shutters) to within the diameter of one marker and, if the diameter is less than 20 mm then alignment complies with the regulations, Greater precision is possible. The recommended maximum deviation is one fourth. You are urged to adjust for the greatest obtainable degree of congruency. {f misalignment is detected in both X and Y directions, check that the spacing from the focal spot to the collimator mounting surface is 70 mm. +/- 1 mm. (2.75" +/-.039"). If the spacing requires adjustment, repeat the test film exposure after the adjustment. {f the collimator mount spacing is correct, but adjustment is still necessary, do not move the collimator relative to the x-ray tube, but proceed as follows: * Place the test film on the face of the cassette over the white paper and place the Cassette in the position originally marked. + Check the correct position of the film by the shadows cast by the markers. * Using the images of the collimator shutters as the reference for the shape and size of the x-ray field, adjust the light field to match. + To move the light field in the cross table direction, unscrew the 4 screws on the lower portion of the cover and remove the cover. Loosen the locking screws sufficiently to Permit turning of the adjuster cam and allow mirror positioning, (Figure 2 page R—2). * Lock the fixing screw and cam after adjusting the mirror position, and replace the cover. INSTRUCTIONS MANUAL MTR72/032/DHHS - page F—2 SeRal COW MODEL R72 J To move the light field in the long direction, remove the cover and the dissipator WARNING: DO NOT IMMEDIATELY TOUCH THE DISSIPATOR WITH YOUR FINGERS IT COULD BE HOT AND CAUSE SEVERE BURNS. «Loosen the two lamp-support fixing screws and using the hexagonal screw on the side of the lamp, adjust the lamp to make the two fields coincide (Figure 3 - page RS) DO NOT TOUCH THE LAMP, THE SOCKET, OR THE LAMP BRACKET WITH YOUR FINGER. THEY CAN BE VERY HOT AND CAUSE SEVERE BURNS. Do not touch the lamp with your fingers, even when it is cold. Oil from your skin will cause the lamp to crack and possibly explode. if you have touched the lamp, wash off the surface with alcohol, then handle the lamp with a piece of paper. «Tighten the screws fixing the lamp support. © To adjust brightness around the edges of the light field, loosen the screws fixing the Screens to the lamp holder and by using the Alien screws move screen to obtain the required adjustment. - See Figure 3 page R—3 * Tighten the screws of the screens. «Repeat the test exposure after adjustment. INSTRUCTIONS MANUAL MTR72/032/DHHS - page F—3Ral CO MODEL R72 G) ADJUSTMENTS Field Size Indication Adjustment. 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. Shutter Dial Pre-Adjustment: ‘+ Rotate the two control knobs to completely close both sets of shutters. ‘+ Use the field light to ascertain that the shutters are in fact closed. ‘* Check that each indicator is precisely over the dial line marked CLOSED. ‘+ If the indicators read "0" when the shutters are closed, all the other dial indications will prove to be correct. Shutter Dial Calibration: «= Measure the x-ray size field shown on the test film. «Adjust the Light field to the same dimension and read the measure on the dial. «Ifthe reading is not within tolerance, adjust the indicator . «Using a size 2 wrench, loosen the Allen screw placed on the side of the knob. Crosshairs, Alignment Activate the light-field. ‘Turn the control knobs to adjust the light-field to a narrow line; each direction in turn. Check that the crosshair line is centred in the narrow light line in each direction. If adjustment is required, remove the cover and loosen the four screws securing the plastic panel to the collimator and position the plate to centre the cross lines in the light lines. * Tighten the four screws and replace the cover. Friction Brake Adjustment * Friction is adjusted for a shutter movement force of 20 cNm. * Ifa shutter control is too loose and does not hold position, or is too tight and is difficult to turn, adjust the appropriate friction brake to obtain the optimum friction - See Figures 3 page R—3. INSTRUCTIONS MANUAL MTR72/032/DHHS - page G—1.Raleo.. MODEL R72 H) COMPLIANCE VERIFICATION 4) MINIMUM FILTRATION REQUIREMENT: 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. WARNING: The following procedures require that x-radiation be produced. Take adequate precautions that no part of human being is exposed to x-radiation, direct or indirect. 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: Table 1 - MINIMUM FILTRATION REQUIREMENT - BEAM QUALITY (HVL) Designed Measured Minimum HVL (mm. of operating range | operating potential| Al) X-Ray System (kVp) (kVp) Below 50 30 0.3 40 0.4 50 0.5 From 51 to 70 St 12 60 13 70 15 ‘Above 71 7H 24 80 23 90 25 100 27 110 3.0 120 32 130 3.5 140 3.8 _ 150 44 The information contained in the above table was extracted from the Code of Federal Regulations FDA 21 1020.30 (m) 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 the primary beam is not less than that shown in the following Total Filtration table: INSTRUCTIONS MANUAL MTR72/032/DHHS - page H-1Raleo.. MODEL R72 Table 2 - Total Filtration of Primary Beam in Aluminium Equivalence Operating Voltage Total Filtration (mm. Al (kVp) Equivalent) | Below 50, 05 From 51 to 70 15 Over 70 2.2 The Aluminium equivalence of each component in the primary beam (x-ray tube and housing, beam limiting device and any additional filtration in the system) is specified on the fhe atari the technical data attached to the component or can be measured. Detormina the total aluminium equivalence in the primary beam and make sure that itis equal or greater than those specified in the above Table 2 (Total Filtration of Primary Beam in Aluminium Equivalence). Quick-check of minimum filtration requirement at a Particular kvp If the total inherent fitration cannot be seen, then the HVL must be obtained with the following procedures: The HVE in millimetres of aluminium in the system under test must be compared with those Specified in Table 1 (MINIMUM FILTRATION REQUIREMENT ~ BEAM QUALITY (HVL)) and must be greater than or equal to the values shown in the table. @ 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 b. Make an exposure at a pre-selected technique factor of 90 kVp and appropriate mA Garntine values with no added fitrtion in the beam; record the reading. Using the type 1100 Aluminium Alloy, tape a total of 2.5 mm of Abminium to the tradow of the collimator. Make an exposure using the same technique factorsy record the reading, Standard absorber method The HVL determination obtained from the following procedures are to be compared with those illustrated in the table 1 (MINIMUM FILTRATION REQUIREMENT. BEAM QUALITY (AVL), The HVL in millimeters of Aluminum obtained during the test must be greater or equal than the values listed in the above mentioned table. @. DIRECT THE CENTRAL X-RAY BEAM PERPENDICULAR AND IN THE CENTER OF A RAD-CHECK WRaUMENT. DETERMINE THE EXACT DISTANCE FROM THE X-RAY TUBE FOCAL SPOT TO THe INDOW OF THE COLLIMATOR ( 193 ¥M - 7.6"). PLACE THE INPUT AREA OF THE RAD-CHECK AT AN EQUAL DISTANCE FROM THE COLLIMATOR WINDOW. COLLIMATE THE BEAM TO Aj AREA SLIGHTLY LARGER THAN THE DETECTOR. INSTRUCTIONS MANUAL MTR72/032/DHHS - page H-2 rrRalee.. MODEL R72 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. Using a set of several sheets of 1100 Aluminium Alloy, each having a thickness of 0.5 or 1.0 mm, tape the filtration to the window of the collimator, Make an exposure for each increments of filtration and record the reading. ©. Plot the exposure readings (log scale) versus the total added filtration thickness on semilog paper, see 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 1 page H-1 nieve Sy TUBE POTENTIAL: 100K - 36nA - 3sec. 000 44991 HH ff 900 700 600) 500 - +004 mad 05 7 35 2 25 3 35 4 48 5 INSTRUCTIONS MANUAL MTR72/032/DHHS - page H-3Raleo.. MODEL R72 2) VISUAL DEFINITION OF X-RAY VERSUS LIGHT FIELD Applicable Chapter : COLLIMATOR CALIBRATION: paragraph 2. Light field to x-ray Field Alignment.page F—2 3) FIELD SIZE INDICATION Applicable Chapter: : COLLIMATOR CALIBRATION: paragraph Field Size Indication Adjustment. page G—1 4) CROSSHAIR ALIGNMENT Applicable Chapter: COLLIMATOR CALIBRATION: PARAGRAPH 2 CROSSHAIRS, ALIGNMENTPAGE G—1 5) LIGHT FIELD ILLUMINATION INTENSITY a) When a light field simulating the X-Ray field is used the illumination provided at 100 cm, cannot be less than : 160 lux (21 CFR 1020.31 (d) (2) (ii) 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. ©) Check that the voltage specified by the manufacturer is applied to the lamp, make certain that all surfaces in the light beam are clean and unobstructed. 4) Place a photometer capable of reading up to 160 lux in the centre of each of the four quadrants of the light field. e) Tur 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 460 lux. Record the measured lux and all data conceming the instrument and the voltage used, INSTRUCTIONS MANUAL MTR72/032/DHHS - page H-4Ral CO MODEL R72 1) OPERATION INSTRUCTIONS WARNING PROLONGED LIGHTING WITHOUT ALLOWING THE LAMP TO COOL CAUSES THE COLLIMATOR TO OVERHEAT IN THE AREA NEAR THE LAMP - THE MAXIMUM LIMIT ADVISED IS 5 SUCCESSIVE LAMP OPERATIONS. THE OPERATOR MUST AVOID OVERHEATING THE COLLIMATOR AND CARE MUST BE TAKEN NOT TO. ‘SCORCH HIMSELF OR THE PATIENT The collimator is normally operated by activating the pushbutton on the lateral panel to switch the light field ON. Light ON time is adjustable from 15 to 45 seconds via the trimmer on the electronic board. The factory setting is approximately 30s. The collimators has been designed to operate as follows: * Supply constantly connected during operation of the equipment. © Quartz iodide lamp ON time for the light field at about 30 s. * Anormal ON/OFF cycle may be repeated twice = 1 minute, followed by 4 minutes OFF. Light/x-ray field, setting: ‘+ The table on the front panel shows the number to set with the knobs index. The number is read by crossing the FFD (SID) in use (horizontal) with the cassette side in cm or inches (vertical) - see the dial on page I—2. Rotate the knobs to select the field at a set FFD. Do not force the knobs, * The collimator is ready — x-rays may be performed. INSTRUCTIONS MANUAL MTR72/032/DHHS - page I—1Ratlee.. MODEL R72 Table on the front panel: The table on the front panel shows the number to be set with the knobs. The number to be sot is read by crossing the FFD-SID value in use with the cassette size in cm on inches. le. at 90 cm FFD(36" SID) and using an 18 cm (7") cassette size, the field to be set would be 32. inch|36" | 40" |72” | sla | 17sl9 | 7” [30 [24.5113.5 10" |41 [37 [20 30 a. 50 12” 149 | 45.5| 24 ee Or 14” |58_|52.5/ 26.5 ~~ rs 16" |65.5[ 60 [33.5 TON . 17" }70_ [65 |35_ . INSTRUCTIONS MANUAL MTR72/032/DHHS - page I—2Raleco.. MODEL R72 J) ROUTINE MAINTENANCE To ensure constantly safe performance of the collimator and its compliance with applicable regulations, a maintenance program is indispensable. Itis the Owner's responsibility to supply or arrange for this service. Cleaning recommendations © The collimator housing must be cleaned as prescribed by the sanitary regulations followed by the operator. * Disconnect supply * Use non abrasive cleaning products. Care must be taken to prevent liquid from entering the collimator. N.B. the collimator cover is not watertight. * Do no re-apply power if inflammable liquids have leaked into the collimator. See the following Maintenance Instructions. Recommended maintenance programme: Ralco suggests a yearly servicing programme. However shorter intervals are advisable when the colimator 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. Calibration procedures must be performed as described in this manual - page F—1 1. Remove the lower cover from collimator. Inspect the moving parts for signs of wear or damage. 2. Check that the screws and tabs which serve to secure the collimator to the flange/tube adapter are correctly tightened. 3. Check the electric system and substitute parts that show wear. 4. Check the Lexan panel and substitute if necessary. 8. Clean the collimator with a soft cloth paying particular attention to the Lexan window. Do not use abrasive or inflammable cleaning products. Sparingly lubricate the moving parts using graphite oi. Wipe away all excess oil Remount the cover. IMPORTANT: make sure to tighten the M6 Allen screws securing 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. Note: 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. INSTRUCTIONS MANUAL MTR72/032/DHHS - page J:Raleo.. MODEL R72 K) TROUBLESHOOTING Should the Collimator become faulty do not use it until completely repaired. 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 it isn't one of the following problems to cause the fault PROBLEM, CAUSE SOLUTION | The collimator is _not|Check supply/ supplied correctly Tension/currentpolarity/ Fuses Check flaments - substitute i j ; necessary. | The lamp fails to switch |“? 27? '$ faulty See Substitution Of The Lamp On on Page L—1 Check supply to the timer. If there is | no output tension, substitute the timer. eae ‘See Substitution Of The Electronic | Timer on page L—1 Check contacts - substitute if ON-Off bution isfauty | Faveere sor See Light field to x-ray Field The collimator is not | Mirrors are not positioned | Alignment. F—2 centred: correctly See COLLIMATOR CALIBRATION: page F—1 Loosen knob screws and adjust - anon Knobs are off index See Field Size Indication Adjustment. mensions tees Light edge definition is Light screen not aligned not good. correctly See Figure 3 page R—-3 | | INSTRUCTIONS MANUAL MTR72/032/DHHS - page K—1Ral COW MODEL R72 L) SUBSTITUTIONS, DISASSEMBLY, TRANSPORT Substitutions: ‘The following operations must be performed by technically prepared and authorised personnel. See Figure 5 - Parts Breakdown on page R—5 Substitution of the lamp: WARNING: DO NOT IMMEDIATELY TOUCH THE DISSIPATOR WITH YOUR FINGURES IT COULD BE HOT AND GAUSE SEVERE BURNS. WARNING: DO NOT TOUGH THE LAMP, THE SOCKET, OR THE LAMP BRACKET WITH YOUR FINGER. THEY CAN BE VERY HOT AND CAUSE SEVERE BURNS. «Disconnect supply «Remove the lower cover * Remove the lamp protection dissipator. | © Carefully remove the faulty lamp. | + Substitute the lamp with an identical lamp (same V, W and filament power) Make sure that the pins are completely inserted in the lamphoider * Check on light field/x-ray field correspondence « Ifnecessary remove the lamp, rotate it 180” axially and re-insert, + Remount the disconnected items Substitution of the electronic timer © Disconnect supply ‘+ Remove the lower cover. «Remove the two screws holding the electronic timer. «Identify the cables and their position on the terminal board. ‘* Disconnect the cables from the terminal board. ® install the new timer by proceeding in a reverse order, pay particular attention to the connection of the cables to the 4-way terminal board. Disassembly ‘* Disconnect supply to the collimator. ‘+ Disconnect the supply cables. > Loosen the 4 fixing screws on the upper part of the collimator - care must be taken not to let the collimator fall. INSTRUCTIONS MANUAL MTR72/032/DHHS - page \—tRal CO MODEL R72 Transport and storage: RevB Suitable packing must be provided for the collimator. Place the collimator in a plastic bag to avoid packing material from entering the collimator. ‘ * Use an appropriate box for transport, shipment or storage taking care to protect the collimator from rough handling. This will avoid damage to the collimator during transport shipment or storage. «Limit Storage conditions: Ambient Temperature = from -40°C to +70°C Relative Humidity = from 10% to 95% ‘Atm, Pressure = from 500 a 1060 hPa. 9 _ FRAGILE X-RAY EQUIPMENT INSTRUCTIONS MANUAL MTR72/032/DHHS - page L—2Ralco.. MODEL R72 RevD M) SPARE PARTS: NOTE: WHEN ORDERING SPARE PARTS, THE CLIENT IS REQUESTED TO SPECIFY THE MODEL AND ‘SERIAL NUMBER OF THE COLLIMATOR CONCERNED. RO 195 TUBE PORT MOUNTING FLANGE, ROTATING, ¢ 45° WITHOUT STOP, 14MM THICKNESS. (R72/032A DHHS). RO 196 “TUBE PORT MOUNTING FLANGE, ROTATING, = 90° WITH STOP AT 0°, 14MM THICKNESS, (R72/032B DHHS). RO 196, FOCUS-SKIN SPACERS RS 006 LAMP 100W 24V . (R72/032B DHHS). RS 050 ROUND PUSHBUTTON, BLACK/CHROMED_ RS 063 TIMER F338 24V - . (R72/032B DHHS). RS 092 LAMP 100w 12 v-. (R72/032A DHHS). RS 204 TIMER FM338 12V -. (R72/032A DHHS). RS 421 ‘CERAMIC LAMPHOLDER, CSA RS 449 ‘ANTIDUST PANEL R72 (CSA) RS 451 GREY KNOB + INDEX_. (R72/032B DHHS). RS 530 UPPER COVER . (R72/032B DHHS). RS 629 RS 633 LOWER COVER IN ABS . (R72/032B DHHS). BLACK KNOB + |NDEX (R72/032A DHHS RS 636 LATERAL PANEL, LONG, WITH INDEX SCALE - . (R72/032B DHHS). RS 637 LATERAL PANEL, ROSS, WITH INDEX SCALE - . (R72/032B DHHS). RS 638 LATERAL PANEL, LONG, WITH INDEX SCALE - BLACK (R72/032A DHHS. RS 639 LATERAL PANEL, CROSS, WITH INDEX SCALE - BLACK (R72/0324 DHHS). RS 640 LOWER GOVER BLACK. (R72/032A DHHS). RS 641 UPPER COVER BLACK . (R72/032A DHHS). RS 648 RETRACTABLE MEASURING TAPE (STARTING POINT 165MM) RS 653 MIRROR, GLASS, 0,8MM THICK FOR RS/032A DHHS) COMPLETE WITH FRAME AND SUPPORT RS 654 MIRROR, GLASS, 1.5 MM THICK FOR RS/032B DHHS) COMPLETE WITH FRAME AND SUPPORTRaleo.. MODEL R72 N) REPAIRS + Retum the collimator to Raico At the customer's expense if the unit is out of warranty. * Provide the collimator with a detailed description (in italian or English) of the functional problems and/or faults. It is important to indicate whether a repair or a complete overhaul is required * Our Quality Contro! will test the collimator, + If the repair involved is extensive, Raico will contact the customer to advise on the repair or possible substitution. O) END OF LIFE DISPOSAL Your collimator contains materials which can be recycled and reused. Specialised companies can recycle your product to increase the amount of reusable materials and to minimise the amount of materials to be disposed of. {t is recommended that you observe Local Laws regulating the disposal of your old set, Should this prove impossible, retum the collimator to Ralco at the purchaser's expense and Ralco will take care of its correct disposal, The product requires correct disposal at the end of its life-cycle and according to the current standards; it cannot be considered as normal waste. The unit must be disposed of through certified environmental management concems or, should you need to replace the unit with new equipment, retuned to Ralco. Please contact us if you require further information, The product contains lead which, if dispersed can be highly contaminating, The symbol: signifies that the products conforms to the environmental requirements of directives 202/95/EC, 2002/96/EC, 2003/108/EC; it must be disposed of correctly at the end of its life-cycle. Ask you local authorities for disposal information, Failure to disposal of this Product correctly is a breach of these provisions. P) WARRANTY: Rev.8 Ralco undertakes to replace and repair any collimator part during a period of 24 monthS Tom the date of invoice and cover the labour costs involved. ‘The warranty applies provided the product has been handled properly in accordance with its operating instructions; presentation is required of the original invoice indicating the date of Purchase, the model and serial number as well as other documents originally supplied with the set. The warranty does not apply if: ‘+The documents have been altered in any way or made illegible; + The mode! or production number on the product has been altered, deleted, removed or made illegible; : * Repairs or product modifications and alterations have been performed by unauthorised persons; INSTRUCTIONS MANUAL MTR72/032/DHHS - P—1Ratleo.. MODEL R72 * Pamage is caused by misuse or neglect, incorrect Watalalion or accidental damage including but not limited to lighting, water or fire * Use of unoriginal spare parts and accessories. In-warranty spares will be available only upon retum to Ralco, at the customer's expense, of the parts considered to be faulty to allow assess the cause of the fault. This warranty does not apply to consumable items such as lamps. Defective material is to be sent to: RALCO SRL WA DEITIGL 13/6, 20046 BiASSONo (m1) - TALIA FAX: +39-0392497,.799 - EMAIL: RALCO@RALCOT Q) SAFETY/RESPONSIBILITY “ Ralco adheres to the directives governing manufacturers of electro-medical equipment: Directive 93/42 CEE para.10 Legislative Decree n* 48 para.10 Raleo shall not be held responsible when instructions provided in the Present manual are not complied with The units of Raleo construction to client specifications (no CE marking) The unit has been modified by the OEM or end user The unit has been installed without respecting the instructions provided in this manual, The unit is used without respecting the instructions provided mine manual, The 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 ports, Ralco shall dectine all responsiblity for any damage, direct or indirect, caused to persons or things by inappropriate accessories. INFORMATION REGARDING ACCIDENTS THAT HAVE OCCURED WHILE USING THE RADIOLOGICAL COLLIMATOR MUST BE REPORTED IMMEDIATELY TO RALCO SRL. INSTRUCTIONS MANUAL MTR72/032/DHHS - Q—2Raleo.. MODEL R72 RovA R) FIGURES, DIAGRAMS, TABLES i NOTE: SHOULD THE ELECTRIC DIAGRAM REQUESTED BY YOU DIFFER FROM THE STANDARD UNIT SUPPLIED ~ PLEASE SEE THE ATTACHMENTS. Figure 4 VIT| MONTAGGIO E REGOLAZIONE MOUNTING AND ADJOUSTEMENT SCREWS:Ratleo.. MODEL R72 Figure 2 Roraziont speccHo MIRROR ROTATION Fano sprcowe MiaRor Locx / econo l JacGOLAZIONE INCUNAZIONE SPECCHIO NSE LMROR AOUUSTMENT INSTRUCTIONS MANUAL MTR72/032/DHHS - R—2 | METRO | TAPE MEASURE |Raleo.. MODEL R72 Figure 3 NOVIMENTO ORIZZONTALE LAMPADA AMP HORIZONTAL MOVEMENT FRIZIONE wOWM. CROSS ich CROSS. Mow. FERMO. SUPPORTO PORTALAMPADA CAMBHOLDER SUPPORT LOCK. Feawo scueaua | 'SOREEN LOCK REGOLATORE. sCHERWO ScReEN. HOLDER. INSTRUCTIONS MANUAL MTR72/032/DHHS - R—3Ral CO. MODEL R72 $136 potathe : IW. Ro 195 : RO 196 INSTRUCTIONS MANUAL MTR72/032/DHHS - R—4Ral CO. MODEL R72 Figure 5 - Parts Breakdown Ee [ = RALCO s.r. INSTRUCTIONS MANUAL MTR72/032/DHHS - R—S- ar meni =e eeRaleo.. MODEL R72 Diagram 1 -Electronic Timer Board FM338 - 24V - | peste {ot ——-o ment jotime—to | eee cots | =e | Yoon TROLLATEStavace Pagal alco INSTRUCTIONS MANUAL MTR72/032/DHHS - R—-6Ralee.. ee MODEL R72 Diagram 2- Electronic Timer Board FM338 - 12V | | | jt LT Jeme ia | a Vt le] meme sig | | stad PH tas Ed ‘ | | | ee Raloo.. eet |e a eae SE Al \| noms cenouiwatiene | + no _| BI (aeRO =a tes CO a a oe TERE Joana: TET a EOE, aT VERUATO [8 Raleo.. TUECTREAL RING 72e008 Tayo INSTRUCTIONS MANUAL MTR72/032/DHHS - R—7Raleo.. MODEL R72 Diagram 3 -Electronic Timer Board, Electric 24V/12V ba ts fi # Pas Were Ty cou ral Baa "racer [Rear rome yo ctooot? | | Rateo., ELECTRON THE® BOARD SSB INSTRUCTIONS MANUAL MTR72/032/DHHS - R—8Raleo.. MODEL R72 Diagram 4 - Board layout 24V/12V cal -| +a AB © | Heals | iovanr! Pagan! Rate wa Tat CCIRONIC MER BOARD FMSSS INSTRUCTIONS MANUAL MTR72/032/DHHS - R—9INFORMATION FOR THE MANUFACTURER ‘THE FOLLOWING FORM IS PROVIDED FOR YOUR COMMENTS AND SUGGESTINGS WITH REGARDS TO THE COLLIMATOR SO THAT WE MAY ENSURE AND IMPROVE THE QUALITY OF (OUR PRODUCTION. ‘SHOULD YOU HAVE ANY COMMENTS AND/OR SUGGESTIONS, PLEASE MAIL THE FORM, POST- FREE,TO ‘Relee.. VIA DEI TIGLI 13/G, 20047 BIASSONO (Ml) - ITALIA DATA: CUSTOMER: ADDRESS: INFORMATION REGARDING POSSIBLE ACCIDENTS THAT MAY HAVE OCCURRED WHILE USING THE COLLIMATOR. | DIRECTIVE 93/42/CEE STATES THAT ACCIDENTS (SUCH AS DEATH OF GREVIOUS INJURY) THAT INVOLVE THE COLLIMATOR DESCRIBED HEREIN, MUST BE REPORTED TO THE MINISTRY (OF HEALTH AND TO THE MANUFACTURER. THE PRESENT FORMS PROVIDED TO REPORT TC ‘Ralee..., POST-FREE, ACCIDENTS OF ‘THE TYPE STATED IN THE DIRECTIVE. DATE: CUSTOMER: ADDRESS:er / We 2 Ralee.. a 2 MODEL R72 Rev'd M) SPARE PARTS: NOTE: WHEN ORDERING SPARE PARTS, THE CLIENT IS REQUESTED TO SPECIFY THE MODEL AND SERIAL NUMBER OF THE COLLIMATOR CONCERNED. TUBE PORT WOUNTING FLANGE, ROTATING, & 45° WITHOUT STOP, 14MM 7 THICKNESS, (R72/032A DHHS). | RO 196 | TUBE PORT MOUNTING FLANGE, ROTATING, = 90° WITH STOP AT O°, 14MM] | THICKNESS, (R72/032B DHHS), RRO 196 | FOCUS-SKIN SPACERS RS 006 _[ LAMP 100W 24v.(R72/0328 DHHS). ED HOT RS 050_| ROUND PUSHBUTTON, BLACK/CHROMED, : TIMER FM338 24V -.. (R72/032B DHHS) Fame 100w 12 v-. (R72/032A DHHS). 5 BO WRNOG? | TIveR FM338 12V - .(R72/032A DHHS). CERAMIC LAMPHOLDER, CSA ANTIDUST PANEL R72 (CSA) GREY KNOB + INDEX... (R72/032B DHHS). UPPER COVER. (R72/0328 DHHS). | RS629_| LOWER COVER IN ABS . (R72/032B DHHS). RS 633 BLACK KNOB + INDEX (R72/032A DHHS RS 636 _| LATERAL PANEL, LONG, WITH INDEX SCALE -.. (R72/032B DHHS). RS 637 _| LATERAL PANEL, CROSS, WITH INDEX SCALE - . (R72/032B DHHS). RS 638 _| LATERAL PANEL, LONG, WITH INDEX SCALE - BLACK (R72/032A DHHS RS639_| LATERAL PANEL, CROSS, WITH INDEX SCALE - BLACK (R72/032A DHHS). RRS 640 | LOWER COVER BLACK. (R72/032A DHHS) RS641_| UPPER COMER BLACK . (R72/032A DHHS). 7 RS 648 _| RETRACTABLE MEASURING TAPE (STARTING POINT 165MM) RO 195 RS 659 | MIRROR, GLASS, 0,BMM THICK FOR RS/O32A DHHS) COMPLETE WITH FRAME AND SUPPORT zs RS asd |MIRROR, GLASS, 1.5 Mi THICK FOR RS/0328 DHHS) COMPLETE WiTH | ~ FRAME AND SUPPORT | i Labels: | ae GaAs INSTRUCTIONS MANUAL MTR72/032/DHHS - page M—1' Ral CO x i MODEL R72 Figure 5 - Parts Breakdown re ane FEST oe SE