Progeny, Inc. 1407 Barclay Blvd. Buffalo Grove, IL 60089 Tel. (847) 850-3800 Fax (847) 850-3801 LINEAR™ IV Automatic Collimation System Installation Operation and Maintenance 00-02-1517 Rev. L Copyright © 1993 Progeny, Inc. Corp. L October 2002 ECN: P0715Cc SECTION 1.0 44 ed 13 14 15 1.6 arg 18 19 2.0 24 2.2 23 24 25 3.0 34 32 3.3 34 40 41 42 43 5.0 5.1 52 53 54 5.5 October 2002 TABLE OF CONTENTS INTRODUCTION .. You Have Legal Obligations. Background. Linear IV Standard Features... Specifications — Linear IV......... Remote Control Unit Interface... Radiation and Mechanical/Electrical Warning. Compatibility. Maintenance...... i European Representative. INSTALLATION. Unpacking... Equipment Supplied. Colimator Mounting. Power Supply Chassis Mounting. Interconnect Wiring.. ALIGNMENT PROCEDURES.. Light Field / X-ray Congruence Test. Field Projection Lamp and Mirror Adjustment. Cross Hair Window Adjustment. Bucky Centering Light-Line Adjustment CALIBRATION.. Calibration Procedure. . ., Disabling Hardware Calibration Interock. Enabling Hardware Calibration Interlock. COLLIMATOR FUNCTION CHECK.. Collimator Function Check Procedures. Horizontal Collimator Function Check... Preparation For Function Check Procedures. Collimator Tit Switch Checkout... Table Tit Switch Checkout (iting Tables Only). (i) PAGE 13 416 417 Coltimatorc C SECTION 56 57 58 5.9 5.10 5.11 5.12 5.13 5.14 6.0 61 XR 8-2.14 XR 8-2.15 XR 8-2.16 XR 8-2.17 XR 8-2.18 XR 82.19 XR 8-2.20 XR 82.21 XR 8-2.09 XR 8-2.24 XR 8-2.25 XR 8-2.27 XR 8-2.29 XR 8-2.30 7.0 7A 72 73 74 75 October 2002 TABLE OF CONTENTS (Continued) PAGE Continuous SID Monitor Checkout. 57 External SID Signal Test (Horizontal). 57 Tilting Table Receptor SID Signal Checkout. 58 External Radiographic IR Signals Checkout. 5-8 External Fluoroscopic IR Signals Checkout 59 Tilting Table Extemal Radiographic IR Signal Checkout. 540 Spotfilm IR Signals Checkout att Stereo/Tomo Bypass Signal Checkout. At Notes on Cassette Tray Adjustment. 41 COMPLIANCE VERIFICATION.. 64 Verification of Tests to be Performe 63 Visual Definition (Radiographic) of X-ray Light Feld 65 Intensity of Light Field Illumination. 6-10 Minimum Field Size. 6-12 X-ray Field/Receptor Center Alignment. 615 Indication of X-ray Field Size. e416 Positive Beam Limitation, 617 X-ray Field Limitation and Alignmen 618 Return to Positive-Beam Limitation with Image Receptor Change. 6-21 Beam Quality (Half-Value Layer (HVL))....-.c--ss 622 Fluoroscopic X-ray Field Limitation... 6-28 Fiuoroscopic Source-to-Skin Distance (SID). 6-34 Primary Barrier ~ X-ray Lockout. 6-37 Alignment of X-ray Field Edges to Selected Portions of the Image Receptor... a 6-37 Alignment of Center of X-ray Field to Center of Selected Portion of Image Receptor 6-39 CONTINUOUS 7A General. 7-2 SID Monitor Installation Guidelines. 72 SID Monitor Potentiometer Adjustment.... 73 (Option) Differential (Table) SID Monitor Potentiometer Verification. 1-4 ‘SID Circuit Verification. 4 (i) Linear lV ColimatorCc ‘SECTION 8.0 84 82 83 84 8.5 86 87 88 89 8.10 8.11 9.0 10.0 G 11.0 a 11.2 11.3 11.4 11.5 11.6 aig 11.8 19 11.10 11.11 14.12 11.13, 11.14 11.15, 120 October 2002 c TABLE OF CONTENTS (Continued) OPERATING INSTRUCTIONS. General Instructions. Front Panel Description.. List of Messages. Radiographic (Automatic) Operation Radiographic (Table Top/Manual) Operation. Continuous and Differential SID Operation... Horizontal (Wall) Operation. Fluoroscopic Operation. Spotfilm Operation... : Tilting Operation and Titing Table Operation. ‘Stereo/Tomo Operation... . REPLACEMENT PARTS LIST. APPENDIX. Definitions... Linear IV Collimator Pausch URO Table Interface... THEORY OF OPERATION. Mechanical Operation... Electrical Operation. Power Supplies......... Continuous SID Circuits. Image Receptor Size Circuit. Collimator Feedback Circuit. AD Converter Circuit. CPU Core Section (Schematic 70-08313 Sheet 1, Board 70-0814)... CPU Display/Key Board Section (70-08313 Sheet 2) CPU Input/Output Section (70-08313 Sheet 3)... Master Board (Schematic 70-08319, Board 70-08320)... Driver Board (Schematic 70-08315, Board 70-08316)... Display Board (Schematic 70-08317, Board 70-08318).. Front Panel 70-08152. Interconnect Cable 70-0816... SCHEMATICS AND BILLS OF MATERIA\ 8-10 e141 8-12 9-4 10-1 10-2 10-6 1-41 11-3 11-3 1-6 11-6 11-6 11-6 11-6 1-7 4-7 1-7 11-8 1-9 1-9 11-9 11-10 12-1 Linear IV CollimatorLIST OF ILLUSTRATIONS SECTION FIGURE PAGE 20 24 ‘Component Identification... 22 22 ‘Collimator Dimensions. 24 2.3 Mounting Holes.. 26 2.4 Wiring Block Diagram, 28 2.5 Exposure Hold Circui 29 2.8 Tomo/Stereo Bypass Circuit. 29 2.7 Image Receptor Circuit... 240 2.8 Vertical SID Monitor Circuit... 242 29 Differential Vertical SID Monitor Circuit. 2412 2.10 Horizontal SID Switch Circuit........ 2413 2.11 Table Tilt Monitor Orientation. 244 2.12 Table Tilt Monitor Circuit. 244 2.13 Power Supply Circuit. 245 2.14 Spotfilm Alignment Switch. 245 2.15 RAD/Fluoro Mode Switch. 246 Cc 2.16 Fluoro/Spot Film Switch. ce 247 2.17 Image intensifier Mode Control. 247 2.18 Tube Select Switch... 2418 30 34 Light Field Congruence. 33 32 Light Field Adjustment. a4 6.0 61 BRH/FDA Compliance Test Stand... 6-2 62 Compliance Stand Detail. 62 63 Light Field vs. X-ray Field Error Measurements. 64 64 Calculation Example. 67 65 Metal Marker Method.. . 67 6.6 _Hal-Value Layer Determination Graphs 627 67 Fluoroscopic X-ray Field Limitation Test Stand Method. 629 68 —_Fluoroscopic X-ray Field Limitation ~ Direct Method. 631 6.9 Image Intensified Fluoroscope, Test Set-Up. 633 6.10 _Image Intensified Fiuoroscope, Metal Marker Method Inside Edge... 6-34 611 Focal Spot Geometry. 6-36 October 2002, (iv) Linear IV Collimator Coc LIST OF ILLUSTRATIONS (Continued) SECTION FIGURE PAGE 6.12 Calculation Example.. 6-41 613 Spotfilm, X-ray Field Limitation, Test Stand Method, Reference. 6-42 6.14 Spotfilm X-ray Field Limitation, Test Stand Method, Actual... . 6-42 8.0 8.1 Linear IV Front Panel 8-2 10.0 40.1 Linear IV Tit Switch Wiring (70-0147)... 104 10.2 Linear IV Feedback Pots Wiring. a 10-4 10.3. Linear IV Motor Wiring 105 11.0 44.1 Linear IV Collimator... 11.2 11.2a _Collimator Block Diagram — General. 11-4 11.2b Collimator Block Diagram — Logic. eae. 11-5 11.3 _ Interconnect Cable (70-08166) 1411 Cc LIST OF TABLES SECTION FIGURE PAGE 5.0 5-41 Linearity Test Record....... a 5-13 60 64 Minimum Beam Quality Requirements. 623 62 Aluminum Equivalent of Primary Beam Total Filtration 6-23, 63 Highest Design Operating Range... 6-26 6-4 Half-Value Layers as a Function of Filtration and Tube Potential for Diagnostic Units. 6.27 10.1 Collimator / Tube mOunting Information. 10-3 Cc October 2002 Ww) Linear IV CollimatorSECTION 1.0 INTRODUCTION October 2002 (1-4) Linear IV CollimatorC €o120 This product has been tested by Underwriter’s Laboratories in conformance with standards set forth by UL 2601-1, CAN/CSA-C22.2 No. 601.1-M-80, and IEC 601-2-32. It has been found to comply with these standards and, therefore, bears the above “Recognized Component” symbol for UL and UL-C. UL File No. £181750 Progeny, Inc. is registered to IS09001, EN46001, and the Medical Device Directive 93/42/EEC Annex II by SGS Yarsley, Ltd Avoid Exposure-Laser ight is emitted from this aperture October 2002 (1-2) Linear IV CollimatorCc C 1.0 1.2 INTRODUCTION This manual contains information for the assembly, installation, adjustment, testing and maintenance of the LINEAR IV radiographic/fiuoroscopic collimator manufactured by Progeny, Inc. ‘YOU HAVE LEGAL OBLIGATIONS ‘The manufacturers of beam limiting devices are required to provide instructions for the assembly, installation, adjustment and testing adequate to assure compliance with applicable provisions of DHHS Performance Standards 21 CFR Sub-Chapter J, Part 1020. ‘Those who assemble or service beam limiting devices must follow the instructions of the original manufacturer and process the FD-2579 Assemblers Report where applicable. You assume responsibility for compliance of this product if you fail to follow the original manufacturer's instructions or modify any component which affects radiation safety. ‘The FDA (BRH) requires that manufacturers must include a specific requirement that the assembler perform all applicable tests at the time of installation. A thorough explanation of the equipment required and step-by-step instructions must be provided by the manufacturer. The instructions include a requirement to record key data to demonstrate at a later time that all tests were performed and that the equipment was left in full compliance with the standards. As an assembler, you must perform these tests for the applicable requirements at the time of installation and following any repairs which could alter the performance. ‘A Compliance Data Log is provided in this manual to record the results of the tests. BACKGROUND An X-ray collimator functions as an apparatus for regulating the cross-sectional size and shape of a beam of radiation which emerges from an X-ray tube. The source of radiation is virtually a point-source and, due to the tube housing design, emerges from the port as a solid diverging cone of radiation. The finite angle of the anode surface limits the X-ray beam on the anode side (heel-effect) forming a ‘D* shaped X-ray field, limiting the useful coverage. In “collimating” a beam to a given size and shape, a geared pair of lead shutters are moved symmetrically into the beam to absorb the unwanted portion of the emerging beam. A second geared pair of shutters are positioned at right angles to the first pair, and again are moved symmetrically into the beam. In this manner, a continuously variable square/rectangular beam is formed. October 2002 (13) Linear IV Collimator