Related Manuals for Ralco MTR 221/A
Summary of Contents for Ralco MTR 221/A
- Page 1 Instruction Manual MTR 221/A - MTR 221/A DHHS MANUAL RADIOLOGICAL COLLIMATOR Confidential Information SERIES R 221/A DHHS SSUED EVISION EVEL ATE OF SSUE 09.05.2006...
- Page 2 LEGAL WARNING HE INFORMATION CONTAINED IN THIS MANUAL IS CONFIDENTIAL HE CONTENTS OF THIS MANUAL INCLUDING ALCO SRL SOFTWARE AND THE COLLIMATOR ITSELF CANNOT BE COPIED NOR REPRODUCED IN ANY WAY HE CONTENTS OF THIS MANUAL MUST ONLY BE USED FOR THE PROPER INTENDED USE FUNCTION AND MAINTENANCE OF THE ALCO COLLIMATOR...
- Page 3 Model Certifications R 221/A TANDARD ERSION FDA C ERTIFIED ERSION AVAILABLE ON R 221/A DHHS REQUEST Revision Level: The English version of this manual is a translation of the Italian text which prevails in case of doubts. Rev. N Date 26.01.2007 MRM/048/06 12.06.2008...
- Page 4 HIS INSTRUCTION MANUAL PROVIDES THE SPECIFICATIONS DIMENSIONS AND FUNCTIONS FOR A STANDARD COLLIMATOR ERSONALIZATIONS ARE AVAILABLE UPON REQUEST ITH PERSONALIZED COLLIMATORS THE CUSTOMER MUST ENSURE THE FOLLOWING HAS BEEN PROVIDED • “C ”, OUR SPECIFIC CODE IS CLEARLY VISIBLE ON THE BACK LABEL AFTER USTOMIZATION ABOVE THE SERIAL NUMBER...
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Page 5: Table Of Contents
ONTENTS DVISORY DJUSTMENTS .....32 IELD NDICATION DJUSTMENT YMBOLS Shutter Dial Adjustment ......32 ......32 ROSSHAIR DJUSTMENT ESCRIPTION ..........6 Friction Brake Adjustment ......32 HARACTERISTICS ..33 ECHANICAL OTION DJUSTMENT PECIFICATIONS Adjustment of Stops ........33 CLOSED Stop Long and Cross Shutters..33 NSTALLATION ......10 OPEN Stop - Long Shutters .......33 OMPATIBILITY OPEN Stop - Cross Shutters ......33 OUNTING THE... - Page 6 ..........54 ISINFECTION ..54 ECOMMENDED AINTENANCE ROGRAM ENERAL ............56 EPAIRS .........56 ND OF ISPOSAL ...........56 ARRANTY OMPONENTS OVERED BY THIS ...........57 ARRANTY ..........57 ISASSEMBLY ......57 RANSPORT AND TORAGE .......58 AFETY ESPONSIBILITY ...........58 ESIDUAL ISKS MTR221/A DHHS...
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Page 7: Advisory
Modello/Model R221/A - R221/A DHHS Ralco ADVISORY HE FOLLOWING INSTRUCTION MANUAL MUST BE READ AND UNDERSTOOD IN ITS ENTIRETY BY THE INSTALLER AND OPERATOR NTENDED SE OF THE OLLIMATOR HIS COLLIMATOR IS DESIGNED TO BE USED WITH A ADIOLOGICAL SYSTEM PRODUCING IONIZING RADIATION... - Page 8 Modello/Model R221/A - R221/A DHHS Ralco HE COLLIMATOR DESCRIBED HERE IS USED ON ADIOLOGICAL SYSTEMS AND IS CLASSIFIED AS A TYPE IX. T ACCORDING TO TTACHMENT HE COLLIMATOR HAS BEEN DESIGNED AND MANUFACTURED IN COMPLIANCE , 2 F 1997, N. 46, I...
- Page 9 Modello/Model R221/A - R221/A DHHS Ralco YMBOLS N THIS MANUAL THE FOLLOWING SYMBOLS ARE USED THE TRIANGLE EMPHASIZES WARNINGS AND CAUTIONARY MESSAGES WHICH ARE IMPORTANT FOR YOUR SAFETY OR EFFICIENT OPERATION OF THE EQUIPMENT HESE WARNINGS MUST BE STRICTLY COMPLIED WITH...
- Page 10 Modello/Model R221/A - R221/A DHHS Ralco SYMBOLS Description Ref. IEC 417-iec Alternating Current 01-14 417-iec Direct Current 01-18 5031 Continuous and Alternating 417-iec 01-19 5033 Current 417-iec Protective Ground 01-20 5019 417-iec Plus; Positive Polarity 01-27 5019 417-iec Minus; Negative Polarity...
- Page 11 Modello/Model R221/A - R221/A DHHS Ralco Description Ref. IEC Caution: Laser Radiation 60825-1 Electrostatic-Sensitive Device Cassette Size Sensing Device Device Requiring Proper attch.4 2002/95/CE Disposal Follow Instructions for Use ISO 7010-M002 MTR221/A - MTR221/A DHHS YMBOLS MANUALE ISTRUZIONI / INSTRUCTION MANUAL...
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Page 12: Characteristics
Modello/Model R221/A - R221/A DHHS Ralco DESCRIPTION Multilayer, square field, manual collimation system with a lightweight and compact design intended for installation on mobile and stationary X-ray equipment. This device has been designed and manufactured for skeletal investigations and ER applications. - Page 13 Modello/Model R221/A - R221/A DHHS Ralco RO 001/A Fixed mounting flange, 20 mm thickness RO 002 Spacers for mounting flange; 1.5 mm thickness RO 041 Mylar mirror, inherent filtration 0.3 mm Al equivalent RO 051 Rotating mounting flange, 18 mm thickness, 136 mm diameter...
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Page 14: Specifications
Specifications of the basic version of the collimator are described here below. Power Supply 24 V AC/ DC - 50/60 Hz - 6.5 A Fuse for power supply protection collimator. Not T 8 A supplied by Ralco. Motor Supplied by Collimator Board n.a. Fuse for Power Supply Protection Collimator. Not n.a. - Page 15 Modello/Model R221/A - R221/A DHHS Ralco SID: (optional) Precision of Measurement with Retractable Tape < 2% SID EN 60601-2-54 Maximum Radiation Leakage Measured at 100 cm with X-ray Beam = 150 kVp - 4 mA < 40 mRh EN 60601-2-54 Potentiometers n.a.
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Page 16: Installation
Modello/Model R221/A - R221/A DHHS Ralco INSTALLATION OMPATIBILITY • Using the dimensions in Fig. Tube Compatibility below, ensure the near port limiter can be inserted in to the X-ray tube port. • Check that the tube housing literature indicates congruent minimum inherent filtration (1 mm) and, that maximum radiation leakage is 30 mR/hour measured at 1 m from the source when operating at its leakage technique factors (150 kVp - 4 mA). -
Page 17: Mounting The Collimator To The Flange
Modello/Model R221/A - R221/A DHHS Ralco • Mount the flange and spacers to the tube port with 4 screws that must be long enough to be driven into the tube port face for at least 5 threads. • Tighten the screws. - Page 18 Modello/Model R221/A - R221/A DHHS Ralco Fig. Mounting Flange MTR221/A - MTR221/A DHHS NSTALLATION MANUALE ISTRUZIONI / INSTRUCTION MANUAL...
- Page 19 Modello/Model R221/A - R221/A DHHS Ralco MTR221/A - MTR221/A DHHS NSTALLATION MANUALE ISTRUZIONI / INSTRUCTION MANUAL...
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Page 20: Electrical Connection
Modello/Model R221/A - R221/A DHHS Ralco LECTRICAL ONNECTION 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... - Page 21 Modello/Model R221/A - R221/A DHHS Ralco • Remount the cover. NCORRECT POWER SUPPLY COULD DAMAGE THE ELECTRONIC TIMER AND OR THE LIGHT SOURCE SUPPLY MAY BE EITHER IN ALTERNATE OR DIRECT CURRENT AKE CERTAIN THAT POLARITY IS RESPECTED MTR221/A - MTR221/A DHHS...
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Page 22: Wiring Diagram
Modello/Model R221/A - R221/A DHHS Ralco Wiring Diagram MTR221/A - MTR221/A DHHS NSTALLATION MANUALE ISTRUZIONI / INSTRUCTION MANUAL... -
Page 23: Operation Instructions Light /X- Ray Field Setting
Modello/Model R221/A - R221/A DHHS Ralco OPERATION INSTRUCTIONS IGHT IELD ETTING • Set the collimator at 100 cm SID. • By rotating the knobs and with the knob index on the front panel, follow the tags of the scale. • Do not force the knobs. - Page 24 Modello/Model R221/A - R221/A DHHS Ralco 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 SID in use (the value indicated by vertical arrow), with the Cassette size value in cm or inches (horizontal arrow).If necessary see...
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Page 25: Calibration
Modello/Model R221/A - R221/A DHHS Ralco CALIBRATION HE FOLLOWING PROCEDURES REQUIRE THAT RADIATION BE PRODUCED AKE ADEQUATE PRECAUTIONS TO MAKE CERTAIN THAT NO PART OF THE HUMAN BODY IS EXPOSED TO X RADIATION DIRECT OR INDIRECT ENTERING EAM WITH OLLIMATOR IGHT •... -
Page 26: Light Field To X- Rayf
Modello/Model R221/A - R221/A DHHS Ralco • Set the X-ray generator to produce a density of about 50 kVp, 5 mAs. • Make an exposure. • Remove the cassette and process the film. • Use the test film to check the alignments described below. -
Page 27: Vertical Alignment
Modello/Model R221/A - R221/A DHHS Ralco • Remove the part of the cover necessary to access the screws, see Chapter - C OVER EMOVAL • Remove the light source protection heatsink by unscrewing the fixing screws . This allows you to access the light source. -
Page 28: Compliance Verification
Modello/Model R221/A - R221/A DHHS 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 Electro-medical equipment. -
Page 29: Quick-Check Of Minimum Filtration Requirement At A Particular Kvp
Modello/Model R221/A - R221/A DHHS Ralco Total Filtration Of Primary Beam In Aluminium Equivalence Total Filtration (mm Al Operating Voltage (kVp) Equivalent) Below 50 From 51 to 70 Over 70 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 component, in the technical data attached to the component or can be measured. -
Page 30: Visual Definition Of
Modello/Model R221/A - R221/A DHHS Ralco c) Plot the exposure readings (log scale) versus the total added filtration thickness on semi-log 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). -
Page 31: Light Field Illumination
Modello/Model R221/A - R221/A DHHS Ralco 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 32: Electromagnetic Immunity For All Equipment And Systems
Modello/Model R221/A - R221/A DHHS Ralco Electromagnetic Immunity for All Equipment and Systems Collimator R221/A - R221/A DHHS is intended for use in the electromagnetic environmenmt specified below. The customer or the user should assure that it is used in such an environment. -
Page 33: Electromagnetic Immunity For Non Life-Supporting System
Modello/Model R221/A - R221/A DHHS Ralco Electromagnetic Immunity for Non Life-Supporting System The R221/A - R221/A DHHS collimator is intended for use in the electromagnetic environment specified below. The customer or the user of the collimator should assure that it is used in such an environment. -
Page 34: Recommended Separation Distances For Non-Life Supporting Equipment
Modello/Model R221/A - R221/A DHHS Ralco Recommended Separation Distances for Non-Life Supporting Equipment Collimator R221/A - R221/A DHHS 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 maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the collimator as recommended below, according to the maximum output power of the communications equipment. -
Page 35: Cover Removal
Modello/Model R221/A - R221/A DHHS Ralco COVER REMOVAL EMOVE THE TWO KNOBS BY UNSCREWING THE TWO DOWELS PER KNOB EMOVE THE SNAP FIT FRONT PANEL BY PRISING IT OFF AS SHOW IN THE PHOTOGRAPH ISCONNECT THE CONNECTOR URN THE COLLIMATOR OVER... - Page 36 Modello/Model R221/A - R221/A DHHS Ralco GENTLY EASE THE TAPE INTO THE COLLIMATOR REMOVE THE SCREW FROM THE SNAP FIT PLATE REMOVE THE PLATE AND THEN LIFT THE COLLIMATOR COVER OFF REMOVE THE COVER BY LIFTING IT OFF THE COLLIMATOR...
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Page 37: Access To Differentc
Modello/Model R221/A - R221/A DHHS Ralco CCESS TO IFFERENT OLLIMATOR OMPONENTS CCESS THE COLLIMATOR POWER SUPPLY BY REMOVING COLLIMATOR BACK PANEL CCESS THE LONGITUDINAL ADJUSTMENT PARTS BY REMOVING THE LATERAL PLATE MTR221/A - MTR221/A DHHS OVER EMOVAL MANUALE ISTRUZIONI / INSTRUCTION MANUAL... -
Page 38: Shutter Dial Adjustment
FACTORY CONFIGURATIONS DJUSTMENTS HAVE BEEN PRESET AT THE FACTORY PRIOR TO SHIPMENT OF THE COLLIMATOR SHOULD ANY PROBLEM ARISE REQUIRING THE NEED TO RECALIBRATE PLEASE CONTACT RALCO FOR ASSISTANCE BEFORE PROCEEDING WITH THE ADJUSTMENT 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 SID in use to within 2% of that SID. -
Page 39: Adjustment Of Stops
Modello/Model R221/A - R221/A DHHS Ralco • Before replacing the knobs, close both shutters and mount/fix the knobs so that the field index is set at “0” (completely closed), see paragraph Shutter Dial Adjustment in this Chapter. ECHANICAL OTION DJUSTMENT The purpose of these stops is to prevent stressing the control shafts of the shutters at the two limits of travel. - Page 40 Modello/Model R221/A - R221/A DHHS Ralco Fig. Cross Shutters Fig. Long Shutters MTR221/A - MTR221/A DHHS DJUSTMENTS MANUALE ISTRUZIONI / INSTRUCTION MANUAL...
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Page 41: Roubleshooting
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... -
Page 42: Ubstitution Of The Halogenl
Modello/Model R221/A - R221/A DHHS Ralco SUBSTITUTIONS UBSTITUTION OF THE ALOGEN NOT IMMEDIATELY TOUCH THE DISSIPATER WITH YOUR FINGERS WARNING IT COULD BE HOT AND CAUSE SEVERE BURNS DO NOT TOUCH THE LAMP THE SOCKET OR THE LAMP BRACKET WARNING... -
Page 43: Parts
Modello/Model R221/A - R221/A DHHS Ralco SPARE PARTS NOTE: When ordering spare parts, the customer is requested to specify the collimator model and serial number. R221/A - R221/A DHHS S TANDARD Cod. Description RS 006 Lamp, 24 V-100W RS 033... -
Page 44: Items
Modello/Model R221/A - R221/A DHHS Ralco OPTIONAL ITEMS This collimator may have the following optional items; a detailed description is provided in this chapter. RO 001/A Fixed Mounting Flange Thickness of this mounting flange is 20 mm. When the collimator is assembled check the collimator to Focal Spot Alignment (Primary Shutter Cut-Off). -
Page 45: 002 Iron Spacer
Modello/Model R221/A - R221/A DHHS Ralco RO 002 Iron Spacer This accessory is used for the mounting flange; 1.5 mm thickness. RO 041 Mylar Mirror Mylar mirror, internal filtration equivalent at minimum 0.3 mm Al. MTR221/A - MTR221/A DHHS PTIONAL... -
Page 46: 051 Rotating Mounting Flange
Modello/Model R221/A - R221/A DHHS Ralco RO 051 Rotating Mounting Flange This accessory is used to rotate the collimator assembled to the X-ray tube. • Flange thickness: 18 mm • Flange diameter: 136 mm When the collimator is assembled check the collimator to Focal Spot Alignment (Primary Shutter Cut-Off). -
Page 47: 058 Rotating Mounting Flange
• Edge contrast (if applicable), • Operation and electronic check up. RO 074 Customized Housing The customer can specify a collimator housing color. Ralco’s standard color is RAL9003. RO 077 Centering Device Centering device of the Potter Bucky (BL). Reflects the lamp light to form a bright line to align collimator to Potter Bucky. -
Page 48: 082 Mirror
Modello/Model R221/A - R221/A DHHS Ralco RO 082 Mirror Glass mirror, 0.8 mm thickness, inherent filtration 1 mm Al equivalent. With this mirror, the collimator equivalent filtration value of 2 mm Al is reduced to 1 mm Al. RO 096 Customized Wiring... -
Page 49: 240 Focus-Skin Distance Spacer
Modello/Model R221/A - R221/A DHHS Ralco RO 240 Focus-Skin Distance Spacer This accessory ensures a minimum safety distance (309.5 mm) between the X-ray focus and the patient. HIS ACCESSORY DEALS WITH PREVENTING THE USE OF INAPPRO PRIATE SMALL FOCUS SKIN DISTANCES... -
Page 50: 242/1 Single Laser
Modello/Model R221/A - R221/A DHHS Ralco RO 242/1 Single Laser Fig. Laser Line The collimator laser is classified as Class 2 (1 m W - wavelength = 645 mm); used for collimator/image receptor center alignment, see Fig. Laser Line. AUTION... -
Page 51: 253 Plastic Spacer Guides
Modello/Model R221/A - R221/A DHHS Ralco • Check the laser alignment, see Chapter- A DJUSTMENTS • Remount the cover, see Chapter- C OVER EMOVAL Classification EN 60825-1 par. 1 -5: Class 2 laser product => Red laser line. RO 253 Plastic Spacer Guides Pair of plastic rail guides complete with support designed to accommodate the ionization chamber and ensure its lateral protection. -
Page 52: 318 Auto Centering Cover With Plastic Flange
Modello/Model R221/A - R221/A DHHS Ralco the front panel. The disk features a hole for the passage of X-rays and accommodates the following three filters: no filtration. 0,1 mm copper 0,2 mm copper 0,3 mm copper Setup of Filters • Rotate the aluminium disc that protrudes from the filter opening on the front panel. -
Page 53: Vertical Alignment
Modello/Model R221/A - R221/A DHHS Ralco Vertical Alignment DO NOT TOUCH THE DISSIPATER WITH YOUR HANDS IT COULD BE HOT AND CAUSE SEVERE BURNS • Remove the part of the cover necessary to access the screws, see Chapter - C... -
Page 54: Transversal Calibration (Cross)
Modello/Model R221/A - R221/A DHHS Ralco Transversal Calibration (CROSS) If the light-field needs calibration, the mirror needs to be adjusted as follows: • Remove the part of the cover neces- sary to access the screws, see Chap- ter - C... - Page 55 Modello/Model R221/A - R221/A DHHS Ralco 1. Vpp J3 - P ROGRAMMING 2. +5 V ONNECTORS 3. GND 4. PGD 5. PGC 6. NC 1. + External LED J4 - H ENSOR NPUT XTER 2. - External LED 3. - Photosensor LED Cathode 4.
- Page 56 Modello/Model R221/A - R221/A DHHS Ralco Trimmers Adjust the output current intensity to the LED. TR1- C URRENT ONTROL Step-less current adjustment from 0 to 5.1 A. Adjusting current to approximately 4.7 A will increase LED life without a significant loss of luminosity.
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Page 57: 336 Spacer Guides
Modello/Model R221/A - R221/A DHHS Ralco RO 336 Spacer Guides Pair of aluminium rail guides designed for an ionisation chamber with different dimensions to standard chamber and to allow the insertion of other accessories. RO 339 Double Laser for Optical SID The collimator has two lasers which serve for the optical definition of the prefixed SID. -
Page 58: 382 Led On Front Panel
Modello/Model R221/A - R221/A DHHS Ralco • Unscrew the fixing Allen screws A, see Fig. Laser Adjustment. • Disconnect the timer cables from the terminal board - white 0 V, red 5 V. • Remove the laser and substitute with an identical item. -
Page 59: 441 Plastic Flange, 50° Rotation
Modello/Model R221/A - R221/A DHHS Ralco RO 441 Plastic Flange, 50° Rotation Plastic flange with notch allowing +/- 50° rotation of the collimator without stop, 20 mm thickness. Available only if collimator is assembled with optional item RO 318. RO 442 Plastic Flange, 90° Rotation Plastic flange with notch allowing +/- 90°... -
Page 60: Aintenance Leaning Recommendations
ECOMMENDED AINTENANCE ROGRAM Ralco suggests a yearly servicing program, 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. - Page 61 Modello/Model R221/A - R221/A DHHS Ralco • Clean the collimator with a soft cloth paying particular attention to the plastic anti-dust window. Do not use abrasive or inflammable cleaning products. • Wipe away all excess oil and remount the cover.
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Page 62: General Repairs
Should this prove impossible, return the collimator to Ralco at the purchaser's expense and Ralco will undertake its correct disposal. If you are replacing the unit with new equipment, you may return the old collimator to Ralco. Please contact us if you require further information. -
Page 63: Components Not Covered By This Warranty
• 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 Ralco to assess the cause of the fault. OMPONENTS... -
Page 64: Safety /Responsibility
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: •... - Page 65 Directive 2007/47/CE states that accidents (such as death or grievous injury to a patient) that involve the collimator described herein, must be reported to the Ministry of Health and to the Manufacturer. The present form is provided to report to Ralco srl post-free. Date:...
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