cm-21-002-revc

Huestis Medical Collimator

Installation Instruction Manual

for

Models 150A

150SA 150PBL

150PBL-I

Part Number: CM-21-002 Revision: C

HUESTISMEDICAL PO Box 718

68 Buttonwood Street Bristol, RI, 02809, USA

401.253.5500 Fax 401.253.7350

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Revision Record 082901-prelim Rev - ECO - Date: 08-29-2001 Software ver: 2.96

120401-prelim Rev - ECO - Date: 12-04-2001 Software ver: 3.05

053102-prelim Rev - ECO1153 Date: 05-31-2002 Replace CM-14-048 w/ Rev A

Software ver: 3.07

092002-prelim Rev - ECO1176 Date: 09-20-2002 Laser label & caution statement

111102-prelim Rev - ECO1182 Date: 11-11-2002 Laser label & caution statement

112002-prelim Rev - ECO - Date: 11-20-2002 Change menu section, general

clean up & updates

Revision: A ECO1205 Date: 02-27-2003

Revision B ECO1238 Date: 12-05-2003

Revision C ECO1457 Date: 07-19-2007

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EU Authorized Representative:

MDSS Burckhardtstr. 1

D-30163 Hannover Germany

Phone:+49-511-62 62 86 30 Fax: +49-511-62 62 86 33

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INSTALLATION INSTRUCTION ADVISORY

TO: INSTALLERS, SERVICE PERSONNEL, AND TECHNICIANS

It is necessary for the assembler to verify compliance. A series of tests, when performed at the time of installation, will indicate compliance with 21CFR, Sub-Chapter J, Part 1020, Performance Standards. These tests which are described in Section 4, “Compliance Verification,” and must be performed before releasing the collimator for use. A record sheet is provided at the end of Section 4 and should be completed by the installer. In order to facilitate a timely installation and ensure compliance it is recommended that the installer review this manual in its entirety and then starting at the beginning, follow all procedures in each section in order.

WARNING! Failure to follow the procedures in this manual may result in an electrical and/or mechanical safety hazard and failure to meet governmental requirements, as well as damage to the collimator.

This unit utilizes a low power (<700 μ watt 650 nm, IEC 60825-1:2001) Class 1 laser to produce an alignment beam. Caution-use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50 dated July 26, 2001 This unit meets IEC61000-4-4 compliance level 1kV. If unit is installed where Transients/Bursts are expected in excess of 1Kv, a power conditioner must be used.

Environmental Range Altitude 0 to 10,000 feet (0 to 3048 meters) (operating) Ambient temperature: +50ºF (+10ºC) to +80ºF (+27ºC) (operating) Ambient temperature: -4ºF (-20ºC) to +122ºF (+50ºC) (shipping, storage) Relative Humidity: 0 to 85% Non condensing (operating) Relative Humidity: 0 to 85% Non condensing (shipping, storage) The original draft of this document is written in English. The revision level of this document is shown on the front cover.

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INSTALLATION INSTRUCTION ADVISORY - CONTINUED

Input Cone Protector Huestis Collimators are equipped with an Input Cone Protector to prevent damage to the lead input cone during transport and to carry a label to remind the installer of Important Information. The protector MUST be removed from the tube side mounting ring before assembly. See illustration below. ------------------- The label reads as follows: IMPORTANT INFORMATION 1 - Read Instruction Manual Before Proceeding 2 - Verify Correct Focal Spot Distance 3 - Do Not Remove Three (3) Detent Ring Screws If Equipped With Detent Option 4 - Remove This Cone Protector Before Installation 5 - DO NOT Rest Collimator On Input Cone ------------------- To Remove Input Cone Protector: (Refer to illustration at right) 1. Remove CM-1016-001 Locking Ring. 2. Lift Mounting Ring/Protector assembly from collimator assembly. 3. DO NOT remove detent ring screws if so equipped. Tamper proof screws are used to deter removal. 4. Remove two (2) screws and nuts fastening the Input Cone Protector. 5. Take note of the information on the label affixed to the Input Cone protector. Continue with collimator installation as outlined in the manual. Avoid damaging the lead input cone.

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Table of Contents

INSTALLATION INSTRUCTION ADVISORY ......................................................................................A

ENVIRONMENTAL RANGE........................................................................................................................... A

INSTALLATION INSTRUCTION ADVISORY - CONTINUED...........................................................B

INPUT CONE PROTECTOR............................................................................................................................ B

1. INTRODUCTION............................................................................................................................... 1

1.1. YOU HAVE LEGAL OBLIGATIONS............................................................................................ 2 1.2. BACKGROUND.............................................................................................................................. 3 1.3. HUESTIS SELECTABLE COLLIMATOR FEATURES ............................................................................... 5

1.3.1. Control Panel Display ............................................................................................................ 5 1.3.2. Menu Selection Buttons .......................................................................................................... 5 1.3.3. Manual Override Controls ..................................................................................................... 5 1.3.4. Field Light Activate ................................................................................................................ 5

1.4. RADIATION AND MECHANICAL/ELECTRICAL WARNING.................................................. 6 1.5. COMPATIBILITY........................................................................................................................... 7

1.5.1. Focal Distance X-ray Tube: ................................................................................................... 7 1.5.2. Leakage radiation: ................................................................................................................. 7 1.5.3. Inherent Filtration and Half-Value Layer: ............................................................................. 7 1.5.4. Application: ............................................................................................................................ 7 1.5.5. Installation: ............................................................................................................................ 7 1.5.6. Collimator Electrical Requirements ....................................................................................... 8

1.6. MAINTENANCE ............................................................................................................................ 8 1.6.1. Cleaning & Disinfecting ......................................................................................................... 8

1.7. COMPLIANCE REQUIREMENTS ................................................................................................ 8

2. INSTALLATION................................................................................................................................ 9

2.1. COLLIMATOR MOUNTING (FIGURE 3 COLLIMATOR MOUNTING ASSEMBLY)............................ 9 2.2. ELECTRICAL CONNECTIONS (24 VAC ONLY)( FIGURE 4) ...................................................... 12

2.2.1. Collimator Electrical Requirements ..................................................................................... 12

3. ADJUSTMENT PROCEDURES..................................................................................................... 14

3.1. FIELD PROJECTION LAMP ADJUSTMENT & REPLACEMENT ........................................... 14 3.1.1. Field Lamp Replacement ...................................................................................................... 15

3.2. VISUAL DEFINITION (RADIOGRAPHIC) OF X-RAY LIGHT FIELD...................................................... 16 3.3. PBL-I IRIS SET UP ADJUSTMENT AND DESCRIPTION ....................................................................... 19 3.4. CROSS-HAIR WINDOW ADJUSTMENT................................................................................... 19 3.5. BUCKY CENTERING LIGHT-LINE ADJUSTMENT ................................................................ 21 3.6. BUCKY CENTERING LASER LIGHT LINE USE ...................................................................... 23

4. USER CONFIGURATION MENUS............................................................................................... 24

COLLIMATOR SOFTWARE CONFIGURATION PROCEDURE.......................................................................... 24 USER PROGRAM SETUP............................................................................................................................. 26 USER CALIBRATION MENU OPTIONS........................................................................................................ 26

• Menu Screen – “Huestis Medical Configuration Menu” (Opening Screen) ................................. 26 • Menu Screen – “Configuration Menu Exit?” ................................................................................ 26 • Menu Screen – Software part number and version information ................................................... 26 • Menu Screen - “Long's Offset”....................................................................................................... 26 • Menu Screen - “Tran's Offset” ....................................................................................................... 26 • Menu Screen – “Fast speed”........................................................................................................... 26 • Menu Screen – “Slow speed” .......................................................................................................... 26 • Menu Screen – “Lamp timeout” ..................................................................................................... 27 • Menu Screen – “Auto lamp?” ......................................................................................................... 27 • Menu Screen – “Lamp Off Bypass”................................................................................................ 27 • Menu Screen – “Left hand bucky OK?” ......................................................................................... 27 • Menu Screen – “Right hand bucky OK?” ...................................................................................... 27

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BEGIN OPTIONAL MENUS ......................................................................................................................... 28 • Menu Screen – “Enable R/F?” ....................................................................................................... 28 • Menu Screen - "Norm's Size"......................................................................................................... 28 • Menu Screen - "Mag1's Size"......................................................................................................... 28 • Menu Screen - "Mag2's Size"......................................................................................................... 28 • Menu Screen – “Mag3's Size" ........................................................................................................ 28 • Menu Screen - "Fluoro trans max" ............................................................................................... 28 • Menu Screen – “Analog film size?”................................................................................................ 29 • Menu Screen - "A Film H long 12" ............................................................................................... 29 • Menu Screen - "A Film H tran 12"................................................................................................ 29 • Menu Screen - "A Film V long 12"................................................................................................ 29 • Menu Screen - "A Film V tran 12" ................................................................................................ 29 • Menu Screen - "Table Top Offset"................................................................................................. 29 • Menu Screen – “Continuous Afilm?”............................................................................................. 29 • Menu Screen – “Use L/P Switch?” ................................................................................................. 29 • Menu Screen – “Analog SID?”....................................................................................................... 30 • Menu Screen - "VSID min dist" ..................................................................................................... 30 • Menu Screen - "VSID max dist" .................................................................................................... 30 • Menu Screen - "VSID sens" ........................................................................................................... 30 • Menu Screen - "Differential SID?" ............................................................................................... 30 • Menu Screen - "Diff SID max height"........................................................................................... 30 • Menu Screen - "Discrete SID?" ..................................................................................................... 31 • Menu Screen – “pgmable disc. SID” .............................................................................................. 31 • Menu Screen - "Table tilt".............................................................................................................. 31 • Menu Screen - "Display tilt" .......................................................................................................... 31

RETURN TO STANDARD USER MENUS........................................................................................................ 32 • Menu Screen - Tilt bypass? ............................................................................................................. 32 • Menu Screen - Default sizes OK? ................................................................................................... 32 • Menu Screen - “Default SIDs OK? “.............................................................................................. 33 • Menu Screen – “Metric display?”................................................................................................... 33 • Menu Screen – “Allow 30X30 Cassette?”....................................................................................... 33

5. COMPLIANCE VERIFICATION.................................................................................................. 35

5.1. VERIFICATION TESTS TO BE PERFORMED:.......................................................................... 35 XR 8-2.09 BEAM QUALITY (HALF-VALUE LAYER (HVL))............................................................ 39

.01 METHOD I - VISUAL DETERMINATION OF HALF-VALUE LAYER (HVL) ............................ 39

.02 METHOD II - STANDARD ABSORBER METHOD ..................................................................... 40

.03 METHOD III - FDA/CDRH COMPLIANCE TEST ...................................................................... 42 XR8 2.13 ACTUAL VERSUS INDICATED SOURCE-TO-IMAGE DISTANCE (SID)....................... 44

.01 Method I - Direct Measurement Method....................................................................................... 44

.02 Method II - Triangulation Method ................................................................................................ 44 XR 8-2.14 VISUAL DEFINITION (RADIOGRAPHIC) OR X-RAY LIGHT-FIELD............................ 46

.01 METHOD I - BRH/FDA COMPLIANCE TEST METHOD .......................................................... 46

.02 METHOD II - METAL MARKER METHOD ................................................................................ 49

.03 METHOD III - ALTERNATE TEST STAND METHOD................................................................ 50 XR 8-2.15 INTENSITY OF LIGHT-FIELD ILLUMINATION.............................................................. 52

.01 METHOD I - DIRECT TEST ........................................................................................................ 52

.02 METHOD II - INDIRECT TEST ................................................................................................... 52 XR 8-2.17 X-RAY FIELD/RECEPTOR CENTER ALIGNMENT ......................................................... 54 XR 8-2.18 INDICATION OF X-RAY FIELD SIZE................................................................................ 55 XR 8-2.19 POSITIVE BEAM LIMITATION (PBL)............................................................................... 56 XR 8-2.20 X-RAY FIELD LIMITATION AND ALIGNMENT ............................................................. 57

.01 METHOD I - FDA/CDRH TEST STAND METHOD .................................................................... 57

.02 METHOD II - ALTERNATE TEST STAND METHOD................................................................. 58

.03 METHOD III - CASSETTE METHOD.......................................................................................... 59 XR 8-2.21 RETURN TO POSITIVE-BEAM LIMITATION (PBL) WITH IMAGE RECEPTOR CHANGE................................................................................................................................................. 60 XR 8-2.22 KEY LOCK TO POSITIVE-BEAM LIMITATION OVERRIDE.......................................... 61 XR 8-2.23 FIELD LIMITATION FOR ONE IMAGE RECEPTOR SIZE............................................... 62

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XR 8-2.24 FLUOROSCOPIC X-RAY FIELD LIMITATION ................................................................ 63 .01 Method I-BRH/FDA Test Stand Method ....................................................................................... 63 .02 Method II-Direct Method .............................................................................................................. 65

XR 8-2.25 FLUOROSCOPIC SOURCE-TO-SKIN DISTANCE (SSD) ................................................. 70 RECORD SHEET.................................................................................................................................... 73

6. LIST OF WARNINGS AND NOTES ............................................................................................. 75

7. APPENDIX........................................................................................................................................ 77

7.1. COMPARISON CHART ............................................................................................................... 77 7.2. REPLACEMENT PARTS ............................................................................................................. 78 7.3. LAMP TIMER ............................................................................................................................... 79 7.4. SCHEMATIC DRAWINGS .......................................................................................................... 82

8. INTERFACE CABLE DETAILS.................................................................................................... 92

8.1. SELECTABLE/PBL COLLIMATOR, HARD WIRE INTERFACE/WIRING SCHEDULE.............................. 93 8.2. HARD WIRE INTERFACE CABLE LAYOUT........................................................................................ 94 8.3. HARD WIRE INTERFACE EXTENSION CABLE WIRING DIAGRAM ..................................................... 95 8.4. RS232 INTERFACE CABLE LAYOUT & WIRING DIAGRAMS............................................................. 96 8.5. RS485 SCHEMATIC & WIRING DIAGRAM ....................................................................................... 98 8.6. CAN BUS SCHEMATIC & WIRING DIAGRAM .................................................................................. 99 8.7. SKIN GUARD.................................................................................................................................. 101

DECLARATION OF CONFORMITY................................................................................................... 102

Table of Figures

FIGURE 1 DIMENSIONS .................................................................................................................................... 1 FIGURE 2 CONTROL PANEL GRAPHICS, SELECTABLE COLLIMATOR ................................................................ 4 FIGURE 3 COLLIMATOR MOUNTING ASSEMBLY............................................................................................ 10 FIGURE 4 ELECTRICAL CONNECTIONS........................................................................................................... 13 FIGURE 5 LAMP REMOVAL & REPLACEMENT................................................................................................ 17 FIGURE 6 LIGHT FIELD ADJUSTMENT............................................................................................................ 18 FIGURE 7 RAD/FLUORO SWITCH CONTACT KEY ........................................................................................... 19 FIGURE 8 CROSS-HAIR WINDOW ADJUSTMENT ............................................................................................. 20 FIGURE 9 LASER BUCKY LINE PROJECTIONS................................................................................................. 22 FIGURE 10 REFERENCE VIEW OF LASER PARTS ............................................................................................ 22 FIGURE 11 EXPLODED VIEW OF LASER......................................................................................................... 23 FIGURE 12 COLLIMATOR CONTROL PANEL .................................................................................................... 25 FIGURE 13 FACEPLATE BUTTON MAP ........................................................................................................... 34 FIGURE 14 GENERAL SET-UP BRH/FDA TEST STAND.................................................................................... 37 FIGURE 15 BRH/FDA TEST STAND SHOWING CHAMBER MOUNTING SLOTS.................................................. 38 FIGURE 16 LIGHT FIELD VS. X-RAY FIELD ERROR MEASUREMENTS............................................................. 41 FIGURE 17 HALF-VALUE DETERMINATION GRAPHS ..................................................................................... 43 FIGURE 18 DETERMINATION OF SID.............................................................................................................. 47 FIGURE 19 METAL MARKER METHOD........................................................................................................... 48 FIGURE 20 GRID ............................................................................................................................................ 64 FIGURE 21 IMAGE RECEPTOR ........................................................................................................................ 67 FIGURE 22 OVER TABLE SOURCE................................................................................................................... 68 FIGURE 23 IMAGE RECEPTOR (OVER TABLE SOURCE) .................................................................................... 68 FIGURE 24 IMAGE RECEPTOR (UNDER TABLE SOURCE) .................................................................................. 69 FIGURE 25 UNDER TABLE SOURCE ................................................................................................................ 69 FIGURE 26 UNDER TABLE TUBES ................................................................................................................... 71 FIGURE 27 FOCAL SPOT GEOMETRY............................................................................................................... 72 FIGURE 29 CM-14-038 LAMP TIMER ............................................................................................................ 79 FIGURE 30 CM-14-002 LAMP TIMER B.O.M................................................................................................. 80 FIGURE 31 CM-14-038 LAMP TIMER BOM................................................................................................... 81

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FIGURE 32 CM-14-002 LAMP TIMER SCHEMATIC......................................................................................... 83 FIGURE 34 CM-14-048 SILKSCREEN LAYER ................................................................................................. 85 FIGURE 35 CM-14-048 SCHEMATIC PAGE1................................................................................................... 86 FIGURE 36 CM-14-048 SCHEMATIC PAGE 2.................................................................................................. 87 FIGURE 37 CM-14-048 SCHEMATIC PAGE 3.................................................................................................. 88 FIGURE 38 CM-14-048 SCHEMATIC PAGE 4.................................................................................................. 89 FIGURE 39 CM-14-021 CONTROL SYSTEM ASSEMBLY REFERENCE.............................................................. 90 FIGURE 40 CM-14-076 CONTROL SYSTEM ASSEMBLY REFERENCE.............................................................. 91 FIGURE 41 RJ45 INTERFACE CABLE.............................................................................................................. 96 FIGURE 42 DS9 INTERFACE CABLE ............................................................................................................... 97

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1. INTRODUCTION

Figure 1 Dimensions

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This manual contains information for the assembly, installation, adjustment, testing and maintenance of the collimators manufactured by HUESTIS MEDICAL.

1.1. 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 FDA-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 (CDRH) 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 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.

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1.2. 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 flat-pair of lead shutters are moved perpendicularly into the beam to absorb the unwanted portion of the emerging beam. A second flat-pair of shutters are positioned at right angles to the first pair, and again are moved perpendicularly into the beam. In this manner a continuously variable square/rectangular beam is formed. The landing area of the beam will contain a radiographic or fluoroscopic image receptor located in a plane perpendicular to the beam at pre-determined distances from the radiation source (focal spot). The size and shape of the image receptor will determine the maximum useful cross-sectional size and shape of the beam in the plane of the image receptor. The source to image receptor distance (SID) determines the actual shutter opening required to regulate the beam size and shape in the plane of the image receptor.

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Figure 2 Control Panel Graphics, Selectable Collimator

CONTROL PANEL GRAPHICS

9 .5 40 .0 9 .5TRAN 0 SI D M LON G

[Menu Button 3] [Menu Button 4]

[Menu Button 1]


[Menu Button 6]

[Menu Button 7]

[Menu Button 9]

[Menu Button 8]

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1.3. Huestis Selectable Collimator Features The 2000 Series Huestis Selectable Collimator provides pre-formatted sizing selection without the

complexity of traditional automatic PBL systems. It allows technicians the ability to easily select film size and SID directly from the front panel. (See Figure 2)

The 3000 Series Huestis PBL Collimator provides the same features as the 2000 Series with the added capability of PBL compliance. This is accomplished via external communications links via Hardwire or Serial cables and specialized programming of the on board micro-processor control electronics. Feedback from various sensors on the X-Ray apparatus to the Collimator provides required information to allow X-Ray exposure only when film size/SID parameters are properly set. The Huestis PBL-I collimator combines the versatility of the standard PBL collimator with the addition of an Iris layer. The Iris provides a circular collimation pattern of the X-Ray beam for use on an Image Intensifier during fluoroscopic examinations.

The micro-processor control electronics are self contained in the collimator head. Directly coupled shutter drive motors provide motion for TRANS, LONG and IRIS adjustments (if equipped). Optical encoder feedback assures accurate positioning.

1.3.1. Control Panel Display The Control Panel Display provides at-a-glance information about the current collimator set-up.

TRANS - Indicates transverse field size at the target and is automatically updated in accordance with the SID requirement. LONG - Indicates longitudinal field size at the target and is automatically updated in accordance with the SID requirement. SID - Source to image distance can be selected as required for the application and will cause automatic resetting of TRANS and LONG field sizes.

MODE - Indicates the current operating mode of the collimator. A = Auto; M = Manual; O = Override

1.3.2. Menu Selection Buttons Pre-programmed buttons give the technician hassle free adjustment options. All pre-programmed settings are adjustable for custom applications.

TRANS INCREASE - Selects the incremental increase of six pre-programmed shutter adjustments. TRANS DECREASE - Selects the incremental decrease of six pre-programmed shutter adjustments.

SID INCREASE - Selects the incremental increase of six pre-programmed SID adjustments. SID DECREASE - Selects the incremental decrease of six pre-programmed SID adjustments.

LONG INCREASE - Selects the incremental increase of six pre-programmed shutter adjustments. LONG DECREASE - Selects the incremental decrease of six pre-programmed shutter adjustments.

1.3.3. Manual Override Controls Eight buttons allow manual adjustment of TRANS and LONG shutter settings. These controls offer a fast selection for quick shutter movement and a slow selection for fine tuning shutter position.

1.3.4. Field Light Activate The field light activate button allows the technician to turn on the field light and laser bucky line indicator. The ON time is processor controlled and is adjustable from 0 to 40 seconds.

LAMP USAGE SHALL NOT EXCEED THREE (3) CONSECUTIVE "ON" CYCLES OF 20 SECONDS WITH A COOL DOWN PERIOD OF FIVE (5) MINUTES. FOR LAMP TIMER SETTINGS LONGER THAN 20 SECONDS ONE (1) ON CYCLE IS PERMITTED WITH A 5 (FIVE) MINUTE COOL DOWN.

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The primary objective of the collimator is to limit the beam to the size of the image receptor and to provide other standardized operations consistent with the DHHS Performance Standards 21 CFR Sub-Chapter J. This is accomplished by measuring the size of the image receptor and the distance (SID) involved, then adjusting the collimator accordingly or by visual means of the light field with respect to the area of interest or image receptor size whichever is smaller.

1.4. RADIATION AND MECHANICAL/ELECTRICAL WARNING (from NEMA Standards Publication/No. XR8-1979)

Radiation Warning for Diagnostic X-Ray Systems X-rays are dangerous to both operator and others in the vicinity unless established safe exposure procedures are strictly observed. The useful and scattered beams can produce serious, genetic or potentially fatal bodily injuries to any persons in the surrounding area if used by an unskilled operator. Adequate precautions must always be taken to avoid exposure to the useful beam, as well as to leakage radiation from within the source housing or to scattered radiation resulting from the passage of radiation through matter. Those authorized to operate, test, participate in or supervise the operation of the equipment must be thoroughly familiar and comply completely with the currently established safe exposure factors and procedures described in publications such as Sub-Chapter J of Title 21 of the Code of Federal Regulations, “Diagnostic X-Ray Systems and their Major Components”, and the National Council on Radiation Protection (NCRP) No. 33, “Medical X-Ray and Gamma-Ray Protection for Energies up to 10 MeV-Equipment Design and Use”, as revised or replaced in the future. Failure to observe these warnings may cause serious, genetic or potentially fatal bodily injuries to the operator or those in the area.

Mechanical/Electrical Warning for Diagnostic X-Ray Systems All of the moveable assemblies and parts of X-ray equipment should be operated with care. Only properly trained and qualified personnel should be permitted access to any internal parts. Live electrical terminals are deadly; be sure line disconnect switches are opened and other appropriate precautions are taken before opening access doors, removing enclosure panels, or attaching accessories. Do not remove the flexible high tension cables from the X-ray tube housing or high tension generator or the access covers from the generator until the main and auxiliary power supplies have been disconnected. When disconnecting high voltage cables, they must be grounded immediately in order to dissipate any electrical charge that may remain on the cables or the tube. Failure to comply with the foregoing may result in serious or potentially fatal bodily injuries to the operator or those in the area.

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1.5. COMPATIBILITY The HUESTIS MEDICAL collimators are compatible and can be adapted for use with X-ray tube/housing assemblies that meet all of the following factors: (See Compatibility Chart page 77)

1.5.1. Focal Distance X-ray Tube:

The focal spot to x-ray tube mounting ring (Fig. 1) top surface distance must be 2.44 inches, + or - 0.031 inches (1/32”). Four (4) spacers are supplied for adaptation:

1 - ¼ inch (0.25”) spacer 3 - 1/16 inch (0.06”) spacer

Use any combination to achieve the requirements. Do not rely on tube markings, reference the x-ray tube data sheet or literature.

1.5.2. Leakage radiation:

Maximum leakage radiation from the X-ray tube/housing assembly must not exceed 50 mR/hr at 1 meter (40 inches) at 150 kVp at 4 ma.

1.5.3. Inherent Filtration and Half-Value Layer:

The HUESTIS MEDICAL collimators have a minimum value of 2.0 mm aluminum equivalence at 70 kVp. This value plus any tube inherent filtration plus any added filtration must meet the minimum requirements of 21 CFR Sub-Chapter J, part 1020.30 (m) (1) Table 1 on beam quality (e.g., minimum HVL at 100 kVp must be 2.7 mm Al) OPTIONAL Cu Spectral Filters: Filtration at 0.1mm Cu: 3.1mm aluminum equivalence. Filtration at 0.2mm Cu: 4.5mm aluminum equivalence.

1.5.4. Application:

The intended application is for overtable general purpose radiographic fluoroscopic equipment including tomographic and chest applications. Maximum tube rating must be 150 kVp or less.

1.5.5. Installation:

Must be made with supplied hardware including mounting flange, spacers (as required), and four (4), ¼” x 20 bolts equally spaced on a 3.62” diameter bolt center.

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1.5.6. Collimator Electrical Requirements

This is a CLASS I electrical device and must be wired in accordance with all applicable electrical codes and regulations. Power Supply Requirement (to comply with light output requirement): Requires an isolated, fused (type 3AG, 3 Amp SLO BLO RECOMENDED) power supply with load voltage of 24VAC at 50/60 Hz at 200 VA (24VAC @ 8 Amps) . Required Voltage Projection Lamp Socket: 21-24 vac true rms with lamp on. Power Supply Cable to Collimator: 20 Feet, 3 conductor, 18 gauge type SJT.

1.6. MAINTENANCE The collimator system must be properly maintained to assure compliance with the CDRH regulations and useful life. Preventive maintenance is to be performed once every twelve months. This includes inspection of the collimator tube mount, electrical cables, electrical connections and lubrication of the collimator. Checkout should also occur if any of the following conditions occur: Lamp replacement. Premature electronic component failure. When the collimator is removed from tube/housing assembly. When the collimator has been subjected to external damage. Should the operator determine there is a problem.

1.6.1. Cleaning & Disinfecting • Turn off power to Collimator power supply before cleaning. • Never use strong solvents such as Thinner, Benzine, Abrasive cleaner, Spray-type cleaner, Wax, Acid or Alkaline solvent. • Housing: Use only a soft cloth lightly moistened with a mild detergent soap. • Crosshair window: Use only a soft cloth lightly moistened with a mild detergent soap. • Field light mirror: A sealed unit should not require cleaning, however, use only a soft cloth, gauze pad or cotton ball lightly moistened with isopropyl alcohol and allow to air dry. • Disinfect control surfaces before each use with a 70% isopropyl alcohol dampened soft cloth.

1.7. COMPLIANCE REQUIREMENTS It is necessary for the assembler to verify compliance. A series of tests, when performed at the time of installation, will indicate compliance with 21CFR, Sub-Chapter J, Part 1020, Performance Standards. These tests which are described in Section 6, “Compliance Verification,” must be performed before releasing the collimator for use. A RECORD SHEET is provided on page 73 and should be completed by the installer.

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2. INSTALLATION Carefully unpack the equipment and check for visible damage incurred during shipment. Any damage should be referred to the agency that delivered the equipment. Verify all contents against the packing list and collect published data for further reference. Take care in handling the collimator and do not set it down on the lead entrance cone or output window.

2.1. COLLIMATOR MOUNTING (Figure 3 Collimator Mounting Assembly)

Determine the x-ray tube mounting ring top surface to focal spot distance from the data supplied with the X-ray tube.(Figure 1) (Do not rely on an inscribed mark on the tube housing)

WARNING!: The collimator will not perform properly unless the focal spot to upper swivel ring (x-ray tube mounting ring) distance is 2-7/16” (2.44 inches, 62 mm) + or - 1/32” (.031 inches, 1mm) or 3” + or - 1/32”. (Figure 1) Be sure to include any permanent tube mounting plates in the focal spot to port boss distance to the top of the housing stated in the tube manufacturer’s data.

WARNING!: The HUESTIS MEDICAL Collimator is designed to be used with a lead diaphragm or input cone in the plastic port of the X-ray tube. Ensure that there is not any mechanical interference between the collimator entrance cone and the lead diaphragm or cone in the port of the X-ray tube.) If it is found that lead diaphragms or cones require removal or modification, consult the factory.

Determine the total thickness of the supplied spacer(s) that must be added between the upper swivel ring (x-ray tube mounting ring) of the collimator mounting surface to obtain a focal spot to upper swivel ring distance of 2-7/16” (2.44 inches, 62mm) + or - 1/32” (.031 inches, 1mm). Refer to Figure 1and Figure 3..

Remove the upper swivel ring from the collimator by removing the 6-32 socket head cap screw and opening the clamping ring.

IMPORTANT: If the optional 90° rotation detent assembly is ordered factory installed DO NOT remove any of its assembly hardware which includes 3 flat head

screws securing the outer ring to the tube mount ring and the 4 flat head screws securing the inner ring /input cone. Follow the collimator mounting instructions as

listed.

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Figure 3 Collimator Mounting Assembly

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In order to insure a safe and secure mounting of the collimator to the X-ray tube housing, the following installation guidelines should be followed.

1. Two different lengths of screws are provided in the mounting kit containing the spacers.

Determine the correct length of screw to use, taking into account the collimator spacing requirements and/or peculiarities of the tube housing port boss.

NOTE: FOR CONVENIENCE, TRUNION MOUNTED TUBE HOUSINGS MAY BE ROTATED UPWARD TO FACILITATE MOUNTING OF THE COLLIMATOR. ANOTHER APPROACH WOULD BE TO USE A BOX TO SUPPORT THE COLLIMATOR AND CAREFULLY BRING THE TUBE HOUSING DOWN TO THE COLLIMATOR.

2. Clean the screws and housing port boss with alcohol and if necessary, remove any debris which may be present in the tube housing mounting holes.

3. Securely fasten the upper mounting ring and spacers to the collimator mounting surface. As a precaution, a medium strength thread locking compound, such as Loctite #242, should be applied to the screws before fastening the collimator mounting ring to the tube housing Verify that the collimator mounting screws engage the tube housing by at least five (5) threads.

4. Carefully support the collimator in place and re-attach the clamp ring. The hinge of the clamping ring must line up with the pin in the lower mounting ring. Apply Loctite to the 6-32 socket head screw holding the clamping ring and securely fasten together.

5. After mounting the collimator and/or performing any service to it or the tube housing, inspect the fit of the collimator and tube housing assembly while inspecting for loose joints or gaps between the tube/collimator assembly as well as other tube mounting areas.

WARNING! Failure to adhere to the above guidelines may result in loosening, damaged screws or mount failure which could result in heavy components falling during use. Incidents of loose system components should be reported immediately to X-ray service personnel for repair.

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2.2. ELECTRICAL CONNECTIONS (24 VAC only)( Figure 4)

2.2.1. Collimator Electrical Requirements

This is a CLASS I electrical device and must be wired in accordance with all applicable electrical codes and regulations. This unit meets IEC61000-4-4 compliance level 1Kv. If unit is installed where Transients/Bursts are expected in excess of 1Kv, a power conditioner must be used. Power Supply Requirement (to comply with light output requirement): Requires an isolated, fused (type 3AG, 3 Amp SLO BLO Recommended) power supply with a load voltage of 24VAC at 50/60 Hz at 200 VA 24vac@ 8 Amps). Use only an IEC 60601-1 approved power supply. Required Voltage Projection Lamp Socket: 21-24 vac true rms with lamp on. Power Supply Cable to Collimator: Standard-20 Feet, 3 conductor, 18 gauge type SJT. All standard Huestis collimators are equipped with a pre wired power cord extending approximately 18 inches from the rear of the unit, terminating in a 3 pin locking connector. Also standard is a mating connector/power cord 20 feet in length. Optional cord lengths are available for special order. Please contact the Huestis Medical sales department for details. Additionally, the collimator may be equipped with a custom length cable as specified by the OEM. Connect the collimator power cord to a proper 24 volt AC power supply as specified elsewhere in this manual.

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Figure 4 Electrical Connections

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3. ADJUSTMENT PROCEDURES The following adjustment procedures are performed with the collimator located in a single fixed position above a test pattern located on the tabletop. The adjustments are made while observing the light field edges. Therefore, it is necessary to confirm that the light field accurately represents the X-ray field. By establishing a defined light field and exposing a film to produce a density of 1.0, the X-ray field (image) can be compared to the light field. The Performance Standards 1020.30 (b) (22) and (45) define the edges of the light field as the locus of points at which the illumination is one-fourth of the maximum and the edges of the X-ray field as the locus of points at which the exposure rate is one-fourth of the maximum. The X-ray field should be determined by exposing a film to a density of 1.0 on the developed image and observing the points at which the density is just visibly increased above the base for background of the film. In a similar manner, the light field edges should be determined by observing the light field on a white background. By observing the points at which the light field is just visibly increased over the background illumination and comparing this with the X-ray field (and to the tolerance marks on the pattern), comparisons may be made. EQUIPMENT REQUIRED:

A. Measuring tape (ruler). B. 14” x 14” X-ray film cassette. C. Densitometer (or a 1.0 neutral density filter for density comparison).

3.1. FIELD PROJECTION LAMP ADJUSTMENT & REPLACEMENT This adjustment must be performed upon initial installation and when the field projection lamp is altered from its original position or is replaced.

WARNING! THE LAMP AND HEAT DEFLECTORS MAY BE HOT ENOUGH TO CAUSE SEVERE BURNS. DO NOT TOUCH ANY OBJECT IN THE LAMP AREA WITH BARE SKIN.

LAMP USAGE SHALL NOT EXCEED THREE (3) CONSECUTIVE "ON" CYCLES OF 20 SECONDS WITH A COOL DOWN PERIOD OF FIVE (5) MINUTES. FOR LAMP TIMER SETTINGS LONGER THAN 20 SECONDS ONE (1) ON CYCLE IS PERMITTED WITH A 5 (FIVE) MINUTE COOL DOWN.

WARNING! THE INTENSITY OF LIGHT OUTPUT IS SUFFICIENT TO TEMPORARILY IMPAIR YOUR VISION IF ALLOWED TO ENTER THE EYES DIRECTLY. DO NOT TURN THE LAMP ON WITH THE REAR COVER REMOVED OR MAINTAIN A POSITION IN WHICH YOU CAN SEE NEITHER THE FILAMENT

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WHEN IT IS OFF, OR ALLOW LIGHT TO DIRECTLY ENTER YOUR FIELD OF VISION WHEN IT IS ON.

WARNING! DISCONNECT PRIMARY POWER TO THE COLLIMATOR POWER SUPPLY ANY TIME THE COVERS ARE TO BE REMOVED.

3.1.1. Field Lamp Replacement 1.The lamp components are HOT after use. Wait at least ten (10) minutes before removing the lamp housing cover at the back of the housing. 2. Remove the 3 locking nuts with a 5/16" socket wrench. (refer to Figure 5 Lamp Removal & Replacement). 3. Remove the defective field lamp bulb and discard. 4. Obtain new field lamp bulb and insure that the lamp is fully seated in the socket and that it is perpendicular to the lamp socket. The location of the filament within the lamp housing is crucial to the successful alignment of the light field.

WARNING! DO NOT TOUCH THE LAMP DIRECTLY. USE A CLOTH OR TISSUE. THIS WILL PREVENT ANY OIL OR CONTAMINATE FROM GETTING ON THE LAMP, POTENTIAL BURNS AND PREMATURE LAMP FAILURE.

5. Replace the rear lamp cover on the collimator.

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3.2. Visual Definition (Radiographic) of X-Ray Light Field Measure and confirm SID at 40” to film. Center the “light field x-ray congruence test pattern” on top of a 14 x 17 cassette. Ensure that the X-ray beam is perpendicular to the image receptor. Selectable and PBL collimators must be adjusted a 10” x 10” field size at 36”, 40”, or 48” SID. ALTERNATE PROCEDURE #1 FOR PBL-I COLLIMATOR PBL-I collimators must be adjusted in RAD mode and set for 36”, 40”, or 48” SID with a 10” X 10” field size in order to allow access to the mirror adjustment screw. If needed access the User Configuration Menus (Refer to section User Configuration Menus for access guidance). Activate the “Default SIDs OK?” menu option and the “Default Sizes OK?” menu option temporarily to adjust the collimator to the required setup parameter. Use the Preset size buttons to obtain 10” x 10” at 36”, 40”, or 48” SID. (After field light alignment is completed reenter the User Configuration Menu and return the “Default SIDs OK?” and “Default Sizes OK?” values to the original values if needed.) ALTERNATE PROCEDURE #2 FOR PBL-I COLLIMATOR Access the User Configuration Menus (Refer to section User Configuration Menus for access guidance). Scroll to NORM Offset menu screen. Record Norm Offset value for later use. Set Norm Offset to a value of 78. Exit the User Configuration Menus and reboot the collimator. Using the lower row of control buttons, collimate the field size down to 10” x 10” at 36”, 40”, or 48” SID. (After field light alignment is completed reenter the User Configuration Menu and return the NORM Offset value to the originally recorded value.) Align the pattern such that the light field coincides with the pattern and tape in place. Place a cassette 14” x 14” on the pattern and place four or more objects (i.e., coins, washers or paper clips) in the 4 corners at the edges and center of the pattern. Expose the film with factors that will produce a density of 1.0. Place the exposed film on the pattern and carefully align the objects in the film to that of the pattern. Verify that the X-ray field is aligned to the pattern within the error boxes as indicated. This is to satisfy the requirement that the sum of the long axis (x1 + x2) shall not exceed 2% of the SID and the sum of the long axis (y1 + y2) shall not exceed 2% of the SID. If the light field is off-centered to the x-ray field in the cross table direction, locate the mirror adjustment screw (refer to Figure 6 Light Field Adjustment) through the hole in the front of the lower corner being careful not to look directly at the light. Being careful of the light output you can close the cross table shutter completely and look up into the collimator and see the adjusting screw at the front top of the collimator, then open back up. Center the light field by turning the mirror adjusting screw clockwise to shift the light field forward, counterclockwise to shift it to the rear. Retest for accuracy. If the light field is mis-aligned in relation to the x-ray field in the longitudinal-table direction, locate the lamp adjustment screw (refer to Figure 6 Light Field Adjustment) through the hole in the back right side of the housing. Center the light field by turning the lamp adjusting screw clockwise to shift the light to the left, counterclockwise to shift to the right, clockwise to the left. Retest with another film.

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Figure 5 Lamp Removal & Replacement

18

Figure 6 Light Field Adjustment

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3.3. PBL-I Iris Set up Adjustment and Description The Huestis PBL-I collimator combines the versatility of the standard PBL collimator with the addition of an Iris layer. The Iris provides a circular collimation pattern of the X-Ray beam for use on an Image Intensifier during fluoroscopic examinations. The Iris beam size is selected via input points on the hardwire interface cable or by special code via serial communications (Document CM-21-013 required for serial communications units and is not discussed in this manual). The Huestis PBL-I collimator supports up to 4 contact closure relays to allow up to 5 states of operation: Radiographic / Fluoroscopic Norm / Fluoroscopic Mag1 / Fluoroscopic Mag2 / Fluoroscopic Mag3. Refer to Figure 7 Rad/Fluoro Switch Contact Key which shows Hardwire Comm pin out specs for each state of operation. User Configuation Menu option “Enable R/F?” must be activated to allow the Rad/Fluoro changeover. This will allow access to the Iris offset menus. The Iris/beam size for each state of Fluoroscopic operation is adjusted via the NORM, MAG1, MAG2, MAG3 Offset values in the User Configuration Menus. Each value is displayed in HEX format. The range is HEX 00 (Minimum opening) to HEX FF (Maximum opening). The values are relative and must be adjusted from the default value to the required value. Use trial and error until the desired beam coverage is obtained for each state at the required, specified SID. Please note that Fluoroscopic states are independent of SID. SID inputs and SID manual selection are disabled in Fluoro Mode.

Figure 7 Rad/Fluoro Switch Contact Key

3.4. CROSS-HAIR WINDOW ADJUSTMENT These procedures are to be performed if the cross-hair shadows are not centered to the light-field. Loosen the 6 screws at the bottom of the collimator (may include the accessory tray securing the plastic window). (Figure 7) Move the plastic window to align and center the cross-hair pattern to the light-field (center lines on the test pattern). Tighten the screws and confirm alignment.

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Figure 8 Cross-hair Window Adjustment

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3.5. BUCKY CENTERING LIGHT-LINE ADJUSTMENT

These procedures are to be performed if the centering light-line is not centered to the correctly adjusted light-field.

WARNING! THE LAMP AND HEAT DEFLECTORS MAY BE HOT ENOUGH TO CAUSE SEVERE BURNS. DO NOT TOUCH ANY OBJECT IN THE LAMP AREA WITH BARE SKIN.

LAMP USAGE SHALL NOT EXCEED THREE (3) CONSECUTIVE "ON" CYCLES OF 20 SECONDS WITH A COOL DOWN PERIOD OF FIVE (5) MINUTES. FOR LAMP TIMER SETTINGS LONGER THAN 20 SECONDS ONE (1) ON CYCLE IS PERMITTED WITH A FIVE (5) MINUTE COOL DOWN.

WARNING! THE INTENSITY OF LIGHT OUTPUT IS SUFFICIENT TO TEMPORARILY IMPAIR YOUR VISION IF ALLOWED TO ENTER THE EYES DIRECTLY. DO NOT TURN THE LAMP ON WITH THE REAR COVER REMOVED OR MAINTAIN A POSITION IN WHICH YOU CAN SEE NEITHER THE FILAMENT WHEN IT IS OFF, OR ALLOW LIGHT TO DIRECTLY ENTER YOUR FIELD OF VISION WHEN IT IS ON.

WARNING!: Disconnect primary power to the collimator power supply any time the covers are to be removed

This unit utilizes a low power (<700 μ watt 650 nm, IEC 60825-1:2001) Class 1 laser to produce an alignment beam. Caution-use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. Complies with 21 CFR 1040.10 and 1040.11 except for deviations pusuant to Laser Notice No. 50 dated July 26, 2001.

Laser Adjustment

1.) Verify alignment of the field light to the X-ray beam. 2.) Remove the bottom housing from the collimator. 3.) Open the laser blocking hood. 4.) Open the far shutter to the maximum setting. 5.) Close the near shutter to project a .25 to .50 wide beam onto the work surface. 6.) Use a "rigid projection board" (piece of cardboard ~12" X 18") to sweep the activated laser/field light

beam from the work surface up to the bottom of the collimator. 7.) Note the laser line to field light position and alignment at the extremes of the projection board

movement.

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8.) Axial angular adjustment: Indicated by an angular mis-alignment of the laser line to the field light

projection. Loosen the 4-40 rotation stop screw (use Phillips screwdriver) and rotate the Line projection lens until the laser line is parallel and in alignment with the field light projection. [NOTE: DO NOT ALLOW THE LINE GENERATOR LENS TO FALL OUT OF THE HOLDER DURING THE ALIGNMENT PROCEDURE!]

9.) Lateral (side to side) adjustment: Loosen the main laser mounting screws and adjust the laser side to

side in the slots provided. Snug the mounting screws. Note-Side to side movement is limited by the aperture slot width. If adjustment is not achieved within the available range be sure the collimator is properly centered on the X-ray tube.

10.) Longitudinal angular adjustment: Indicated by the laser line projection moving from one side to the

other of the field light projection. Loosen the main laser mounting screws 1/2 to 3/4 turn. Use the set screws provided in the laser mounting base to change the base angle of the laser mount. Snug the mounting screws.

11.) Reinstall the bottom housing on the collimator. Be sure to insert the laser blocking hood handle into

the slot in the bottom housing.

Figure 9 Laser Bucky Line Projections

Figure 10 Reference View Of Laser Parts

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3.6. BUCKY CENTERING LASER LIGHT LINE USE The Bucky Centering Laser Light Line generator projects a red laser line (<700 μ watts @ 650nm) from approximately the center of the collimated x-ray field to approximately 21 inches from the center of the collimated x-ray field (at 40" SID). This allows for alignment of film cassettes on the bucky tray. The Bucky Centering Laser Light Line is activated whenever the field indicator light is activated and it stays on for the same time setting. NOTE: IN THE EVENT THAT THE FIELD LIGHT MUST BE ACTIVATED IN A POSITION THAT THE LASER BUCKY LINE COULD PROJECT INTO THE PATIENT'S OR OPERATOR'S EYES, AN INTEGRAL BLOCKING HOOD IS INCORPORATED AND SHOULD ONLY BE OPENED WHEN SPECIFIC USE OF THE LASER IS REQUIRED!

Figure 11 Exploded View Of Laser

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4. User Configuration Menus

Collimator Software Configuration Procedure 1. Set the key switch on the rear of the collimator to the override position (key is NOT removable in this

position) BEFORE power is turned on.

2. Connect collimator to appropriate power supply.

3. Power ON collimator.

4. Refer to Figure 12 Collimator control panel for menu button locations.

5. Upon completion of the BOOT sequence, menu screen "Huestis Medical Configuration Menu"

appears. Press both [Menu Button 7] & [Menu Button 9] simultaneously.

6. Press [Menu Button 1] to SCROLL UP for access to the user menu screens beginning with menu

screen "Maintenance menu exit?" on through "Metric display".

7. Set the options as needed by the customer’s installation requirements.

8. Optional menu screens may appear after the screen “Right Hand Bucky OK?” and before the screen

“Tilt Bypass?” only if installed at the factory.

9. See the following pages for an explanation and set up guide for each User Menu Screen. NOTE-Some

program additions or changes may affect the order of menu appearance. Confirm the exact “statement”

on the menu screen with this manual during set up.

10. When set up is completed, select YES [Menu Button 3] at menu screen "Maintenance Menu Exit?"

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Figure 12 Collimator control panel

9 .5 40 .0 9 .5TRAN 0 SI D M LON G


[Menu Button 1]


[Menu Button 6]

[Menu Button 7]

[Menu Button 9]

[Menu Button 8]

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User Program setup Menu sequence outlined is for software part number CM-24-003 V3.18. User menu selections are available for configuration on all microprocessor-controlled collimators. Some of these menu selections have no impact on the Selectable model and are so identified. Optional menu selections are available for configuration only if installed by the factory.

User Calibration Menu Options

• Menu Screen – “Huestis Medical Configuration Menu” (Opening Screen) Affects: Selectable, PBL, PBL-I Identifies to the user that the collimator MAY be entered into configuration mode. Refer to Collimator Software Configuration Procedure

• Menu Screen – “Configuration Menu Exit?” Affects: Selectable, PBL, PBL-I Allows the user to exit the configuration menu of the program Refer to Collimator Software Configuration Procedure

• Menu Screen – Software part number and version information Affects: Selectable, PBL, PBL-I

• Menu Screen - “Long's Offset” Default value = 80[HEX] Affects: Selectable, PBL, PBL-I Changing this value will increase/decrease longitudinal shutter opening throughout the operating range of the unit. [Menu Button 3] Tens Value Increase; [Menu Button 4] Tens Value Decrease [Menu Button 5] Ones Value Increase; [Menu Button 6] Ones Value Decrease

• Menu Screen - “Tran's Offset” Default value = 80[HEX] Affects: Selectable, PBL, PBL-I Changing this value will increase/decrease transverse shutter opening throughout the operating range of the unit. [Menu Button 3] Tens Value Increase; [Menu Button 4] Tens Value Decrease [Menu Button 5] Ones Value Increase; [Menu Button 6] Ones Value Decrease

• Menu Screen – “Fast speed” Default value = 1; Value range = 1 - 6 Affects: Selectable, PBL, PBL-I Changing this value will increase/decrease the fast opening/closing speed of the shutters. Value increase = slower speed [Menu Button 5] Speed Slower ; [Menu Button 6] Speed Faster

• Menu Screen – “Slow speed” Default value = 7; Value range = 2 - 7 Affects: Selectable, PBL, PBL-I Changing this value will increase/decrease the slow opening/closing speed of the shutters. Value decrease = faster speed [Menu Button 5] Speed Slower ; [Menu Button 6] Speed Faster

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• Menu Screen – “Lamp timeout” Default value = 20 Affects: Selectable, PBL, PBL-I Controls the ON time of the field lamp. Maximum ON time = 45 seconds [Menu Button 5] Time Increase ; [Menu Button 6] Time Decrease

• Menu Screen – “Auto lamp?” Default value = NO Affects: Selectable, PBL, PBL-I Selecting YES will allow the field lamp to automatically turn ON when changing the field size. Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6]

• Menu Screen – “Lamp Off Bypass” Default value = NO Affects: PBL, PBL-I w/ hardwire comm. Selecting YES will disable the OFF cycle of the external lamp activation switch. Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6]

• Menu Screen – “Left hand bucky OK?” Default value = NO Affects: Selectable, PBL, PBL-I SEE NOTES Selectable - Does not prohibit operation of unit but proper selection of Bucky installation prevents error indication. PBL & PBL-I Select YES if left hand wall bucky is present Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6]

• Menu Screen – “Right hand bucky OK?” Default value = NO Affects: Selectable, PBL, PBL-I SEE NOTES Selectable - Does not prohibit operation of unit but proper selection of Bucky installation prevents error indication. PBL & PBL-I Select YES if right hand wall bucky is present Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6]

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Begin Optional Menus THESE MENU ITEMS NOT AVAILABLE ON SELECTABLE COLLIMATOR

• Menu Screen – “Enable R/F?” Default value = NO Affects: PBL-I ONLY Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] If YES is selected, allows access to the following menu screens:

• Menu Screen - "Norm's Size" Default value: F0 HEX

Sets the Iris size outside the Shutter field size in Radiographic Mode [Menu Button 3] Tens Value Increase; [Menu Button 4] Tens Value Decrease [Menu Button 5] Ones Value Increase; [Menu Button 6] Ones Value Decrease

• Menu Screen - "Mag1's Size" Default value: C0 HEX

Sets the Iris size inside the Shutter field size in Fluoroscopic Mag 1 Mode [Menu Button 3] Tens Value Increase; [Menu Button 4] Tens Value Decrease [Menu Button 5] Ones Value Increase; [Menu Button 6] Ones Value Decrease

• Menu Screen - "Mag2's Size" Default value: 80 HEX


• Menu Screen – “Mag3's Size" Default value: 20 HEX


• Menu Screen - "Fluoro trans max" Default value: 16.0; Value range: 9.0 – 17.0

Sets the maximum Iris adjustment size [Menu Button 3] Tens Value Increase; [Menu Button 4] Tens Value Decrease [Menu Button 5] Ones Value Increase; [Menu Button 6] Ones Value Decrease

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• Menu Screen – “Analog film size?” Default value = NO Affects: PBL, PBL-I Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] If YES is selected the following menus are required for calibration of horizontally or vertically mounted (TABLE OR WALL Bucky) film cassettes:

• Menu Screen - "A Film H long 12" Reference value approx. HEX 247 This value is obtained from an external input from the wall bucky cassette tray. [Menu Button 8] To set

• Menu Screen - "A Film H tran 12" Reference value approx. HEX 247 This value is obtained from an external input from the wall bucky cassette tray. (If using 10” x 12” cassette for setup, remove and insert w/ 12” in TRAN direction.) [Menu Button 8] To set

• Menu Screen - "A Film V long 12" Reference value approx. HEX 247 This value is obtained from an external input from the table bucky cassette tray. [Menu Button 8] To set

• Menu Screen - "A Film V tran 12" Reference value approx. HEX 247 This value is obtained from an external input from the table bucky cassette tray. (If using 10” x 12” cassette for setup, remove and insert w/ 12” in TRAN direction.) [Menu Button 8] To set

• Menu Screen - "Table Top Offset" Default value = 0.0; Value range 0.0 – 10.0 [Menu Button 3] Tens Value Increase; [Menu Button 4] Tens Value Decrease [Menu Button 5] Ones Value Increase; [Menu Button 6] Ones Value Decrease

• Menu Screen – “Continuous Afilm?” Default value = NO Affects: PBL, PBL-I Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] If YES selected, this option allows continuous analog film sizing via hardwire communication port.

• Menu Screen – “Use L/P Switch?” Default value = NO Affects: PBL, PBL-I Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] If YES selected, this option allows Landscape/Portrait resizing via PINS 4 & 8 on hardwire communication port.

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• Menu Screen – “Analog SID?” Default value = NO Affects: PBL, PBL-I Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] If YES selected, allows external SID analog input via the communications link, allows access to the following menu screens:

• Menu Screen - "VSID min dist" Default value = 20.0 Sets the minimum SID. If X-ray device is set to this SID an error message will be returned. Requires SID reference signal. 1) Set minimum SID display value: [Menu Button 3] Tens Value Increase; [Menu Button 4] Tens Value Decrease [Menu Button 5] Ones Value Increase; [Menu Button 6] Ones Value Decrease 2) Adjust X-ray device to minimum SID 3) Set input from reference signal: [Menu Button 8] To set

• Menu Screen - "VSID max dist" Default value = 80.0 Sets the maximum SID. If X-ray device is set to this SID an error message will be returned. Requires SID reference signal. 1) Set maximum SID display value: [Menu Button 3] Tens Value Increase; [Menu Button 4] Tens Value Decrease [Menu Button 5] Ones Value Increase; [Menu Button 6] Ones Value Decrease 2) Adjust X-ray device to maximum SID 3) Set input from reference signal: [Menu Button 8] To set

• Menu Screen - "VSID sens" Default value = 3; Value range 0 - 15 Set the feedback sensitivity of the analog SID signal [Menu Button 5] Value Increase; [Menu Button 6] Value Decrease

• Menu Screen - "Differential SID?" Default value = NO Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] If YES selected, the following menu screen must be configured:

• Menu Screen - "Diff SID max height" This setting assumes use of same type of SID monitor kit on table and overhead tube crane (OTC). This calibrates the collimator to know the SID value at Max table height and resets the SID differential as the table is lowered (increasing the SID). [Menu Button 8] To set

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• Menu Screen - "Discrete SID?" Default value = NO Affects: PBL, PBL-I Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] If YES selected, the following menu screen must be configured:

• Menu Screen – “pgmable disc. SID” Default value = NO Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] Selecting YES permits Discrete SID feedback from switches located on X-ray device

• Menu Screen - "Table tilt" Default value = disabled Affects: PBL, PBL-I Available selections – “disabled”, "left", "right". [Menu Button 5] Scroll up; [Menu Button 6] Scroll down Allows the use of the discrete SID 40 Horizontal/Table vertical parameter. In this case a film cassette is loaded into the table bucky then the table is rotated 90° (left or right). This allows the rotated collimator to accept table bucky film feedback.

• Menu Screen - "Display tilt" Default value = NO Affects: PBL, PBL-I Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] Selecting YES displays the tilt angle on the lower line of the display between "TRAN" & "SID" (not operational, future development)

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Return to standard user menus

• Menu Screen - Tilt bypass? Default value = NO Affects: Selectable, PBL, PBL-I SEE NOTES Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] Selecting YES allows collimator to disregard tilt sensor info Selectable - Not required, however, selecting YES may avoid nuisance error messages on unit installed on rotating head. PBL, PBL-I - Special circumstances ONLY

• Menu Screen - Default sizes OK? Default value = YES Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] Affects: Selectable, PBL, PBL-I If NO selected the following preset film sizes may be deselected to streamline Preset Film Size Menu: "Enable 5.0 film?" Default value = YES "Enable 6.5 film?" Default value = YES "Enable 7.0 film?" Default value = YES "Enable 8.0 film?" Default value = YES "Enable 8.5 film?" Default value = YES "Enable 9.5 film?" Default value = YES "Enable 10.0 film?" Default value = YES "Enable 11.0 film?" Default value = YES "Enable 12.0 film?" Default value = YES "Enable 14.0 film?" Default value = YES "Enable 15.8 film?" Default value = YES "Enable 17.0 film?" Default value = YES • Menu Screen - "Enable pgramble film?" Default value - NO Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] If YES selected, allows a custom film size to be entered into the Preset Film Size Menu selection set:

“Pgm film size X” [Menu Button 3] Tens Value Increase; [Menu Button 4] Tens Value Decrease [Menu Button 5] Ones Value Increase; [Menu Button 6] Ones Value Decrease “Pgm film size Y” [Menu Button 3] Tens Value Increase; [Menu Button 4] Tens Value Decrease [Menu Button 5] Ones Value Increase; [Menu Button 6] Ones Value Decrease

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• Menu Screen - “Default SIDs OK? “ Default value = YES Affects: Selectable, PBL, PBL-I Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] If NO selected, the following preset SID sizes may be deselected to streamline Preset SID Menu:

“Enable 36.0 SID?” Default value = YES “Enable 40.0 SID?” Default value = YES “Enable 48.0 SID?” Default value = YES “Enable 72.0 SID?” Default value = YES “• Menu Screen - Enable pgmable SID?” Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] If YES selected, allows a custom SID size to be entered into the Preset SID Menu selection set:

“Pgm SID size” [Menu Button 3] Tens Value Increase; [Menu Button 4] Tens Value Decrease

[Menu Button 5] Ones Value Increase; [Menu Button 6] Ones Value Decrease

• Menu Screen – “Metric display?” Default value = NO Affects: Selectable, PBL, PBL-I Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] Selecting YES will cause all displayed values to be converted to METRIC equivalent values.

• Menu Screen – “Allow 30X30 Cassette?” Default = NO Affects: PBL, PBL-I Buttons toggle YES/NO response: [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] Selecting YES causes the Analog Film Size menu options to be set for a 30X30 Cassette instead of the standard 10X12 Cassette.

END OF USER MENU OPTIONS

CONTINUE TO SCROLL FORWARD TO MENU SCREEN "COFIGURATION MENU EXIT?" THEN PRESS ANY OF [Menu Button 3][Menu Button 4][Menu Button 5][Menu Button 6] TO SAVE SELECTIONS AND EXIT MENU MODE.

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Figure 13 Faceplate Button Map

1 2

3 4

5 6

98

7

35

5. COMPLIANCE VERIFICATION It is necessary for the assembler to verify compliance. A series of tests, when performed at the time of installation, will indicate compliance with 21 CFR, Sub-Chapter J, Part 1020, Performance Standards. The following tests are from the NEMA Standards Publication, No. XR 8-1979 (Test Methods for Diagnostic X-ray Machines for Use During Initial Installation). For each compliance item, there may be a variety of test methods described. Which method is used will depend on the tester’s experience, availability of equipment, time, or special requirements of the HUESTIS MEDICAL Collimator. Any reference tolerances on compliance items are referenced directly from 21 CFR, Sub-Chapter J, Regulations. They do not take into account inaccuracies brought about by the test equipment, instrumentation, or the human element. These factors must be considered when these tests are performed and the compliance of the equipment is being determined.

5.1. VERIFICATION TESTS TO BE PERFORMED: Test Procedure or Requirement Applicable Paragraph 1. Determination of Half Value Layer (Beam Quality) XR8/2.09 2. Actual vs. Indicated SID XR8/2.13 3. Visual Definition of X-ray Light-Field XR8/2.14 4. Intensity of Light Field Illumination XR8/2.15 5. X-ray Field/Receptor Center Alignment XR8/2.17 6. Indication of Field Size XR8/2.18 7. Positive Beam Limitation (PBL) XR8/2.19 8. X-ray Field Limitation and Alignment XR8/2.20 9. Return to PBL With Image Receptor Change XR8/2.21 10. Key Lock PBL Override XR8/2.22 11. Field Limitation for One Image Receptor Size XR8/2.23 12. Fluoroscopic X-Ray Field Limitation XR8/2.24 13. Fluoroscopic SSD XR8/2.25 RECORD THE RESULTS ON THE RECORD SHEET SUPPLIED AT THE END OF THE SECTION.

36

Radiation Warning for Diagnostic X-Ray Systems

X-rays are dangerous to both the operator and others in the vicinity unless established safe exposure procedures are strictly observed. The useful and scattered beams can produce serious, genetic or potentially fatal bodily injuries to any persons in the surrounding area if used by an unskilled operator. Adequate precautions must always be taken to avoid exposure to the useful beam, as well as to leakage radiation from within the source housing or to scattered radiation resulting from the passage of radiation through matter. Those authorized to operate, test, participate in or supervise the operation of the equipment must be thoroughly familiar and comply completely with the currently established safe exposure factors and procedures described in publications such as Sub-Chapter J of Title 21 of the Code of Federal Regulations, “Diagnostic X-ray Systems and their Major Components,” and the National Council on Radiation Protection (NCRP) No. 33, “Medical X-ray and Gamma-Ray Protection for Energies up to 10 Me V-Equipment Design and Use,” as revised or replaced in the future. Failure to observe these warnings may cause serious, genetic or potentially fatal bodily injuries to the operator or those in the area.

37

Figure 14 General Set-Up Brh/Fda Test Stand

SPACERBEAM DEFININGAPERTURE

ALUMINUMABSORBERPOSITION

ION CHAMBER

SLIDE ASSEMBLY

38

Figure 15 Brh/Fda Test Stand Showing Chamber Mounting Slots

1

2

3

4

5

6

7

8

SLOT NUMBER

TRIPODHOLES

CHAMBERMOUNTS

A

B

LEFT SIDE MOUNTING HOLES FOR COMPLIANCE TESTING

39

XR 8-2.09 BEAM QUALITY (HALF-VALUE LAYER (HVL)) REQUIREMENT - The minimum beam quality requirements listed in Table 1 shall be met. (See 21 CFR 1020.30(m).)

.01 METHOD I - VISUAL DETERMINATION OF HALF-VALUE LAYER (HVL)

A. General The above HVL requirement will be considered to have been met if it can be demonstrated that the aluminum equivalent of the total filtration in the primary beam is not less than that shown in Table 2.

B. Equipment None required.

Table 1 Minimum Beam Quality Requirements

KVp Range Measured kVp HVL (mm Al*) Below 50…………………30 0.3 40 0.4 49 0.5 50 to 70………………….50 1.2 60 1.3 70 1.5 Above 70………………..71 2.1 80 2.3 90 2.5 100 2.7 110 3.0 120 3.2 130 3.5 140 3.8 150 4.1 *Type 1100 aluminum alloy as given in Aluminum Association Publication No. ASD-1, Aluminum Standards and Data.

Table 2 Aluminum Equivalent Of Primary Beam Total Filtration

TOTAL FILTRATION OPERATING VOLTAGE (kVp) (mm Al Equivalent) Below 50……………………………………………………. 0.5 50 - 70………………………………………………………. 1.5 Above 70……………………………………………………. 2.5

C. Procedure Visually inspect the system and determine the aluminum equivalence of the total filtration in the primary beam. This includes the inherent filtration of the X-ray tube, X-ray tube housing, beam-limiting device, and any additional filtration that may have been added in the useful beam (in fluoroscopic systems the tabletop is included as part of the added filtration).

40

D. Verification Of Compliance The aluminum equivalence of the total filtration must be equal to or greater than the amount specified in Table 2.

NEMA Standard 5-15-1979

.02 METHOD II - STANDARD ABSORBER METHOD

A. General This test is to be used when the surveyor cannot remove or see the total filtration equivalence.

The HVL determinations obtained from the following procedures are to be compared with those illustrated in Table 1. The HVL in millimeters of aluminum of the system being tested must be greater than or equal to the values shown in Table 1.

B. Equipment 1. Radiation detector. 2. Standard absorber with equivalent filtration of 2.5 millimeters of aluminum.

C. Procedure 1. With the detection device positioned horizontally, an exposure is made at a preselected

technique factor of 80 kVp and appropriate mA and time. The reading of the radiation output is recorded.

2. Position a total of 2.5 millimeters of aluminum at the port of the beam-limiting device and

repeat the exposure using the same technique factors. Record the radiation output.

For X-ray units operating at low kVp (less than 50) and for mammography units, it will be necessary to use an aluminum absorber of 0.6 millimeters at 49 kVp.

D. Verification Of Compliance

Verify that the radiation output in Step 2 is greater than or equal to 50 percent of the radiation output in Step 1.


41

Figure 16 Light Field vs. X-Ray Field Error Measurements

L2 = 0ONLY(IN THISEXAMPLE)

W2

L1

W1

EDGE OF DIRECT PRINT PAPER

IMAGE OF METAL STRIPS

DOTTED LINE REPRESENTSPERIMITER OF LIGHT FIELD

AND CORRESPONDS TOOUTER EDGE OF

METAL STRIPS

EDGE OF THEX-RAY FIELD

42

.03 METHOD III - FDA/CDRH COMPLIANCE TEST

A. General The HVL determinations obtained from the following procedures are to be compared with those illustrated in Table 1. The HVL in millimeters of aluminum of the systems being tested must be greater than or equal to the values shown in Table 1.

B. Equipment 1. BRH/FDA compliance test stand with accessories. 2. Survey meter adapted for use with stand with an ion chamber. 3. Several sheets of aluminum, each having a thickness of 0.5 or 1.0 millimeter.

C. Procedure 1. Attach the spacer, positioned out of the primary beam, to the test stand. Center the stand on

the table. Center the source over the stand and bring the beam-limiting device down into firm contact with the spacer. Select the MANUAL mode of operation (there must not be a cassette in the cassette tray). Insert the beam-defining assembly in slot 1 of the stand with the leaded side up. Adjust the beam-limiting device so that the X-ray field slightly exceeds the aperture of the beam-defining assembly. Mount the ion chamber at position B with the chamber facing upward. Connect the chamber and meter with the cable provided. Select a tube potential that is commonly used and is in the highest kVp range of the X-ray system.

2. With no added filtration in the beam, make an exposure and record the reading. For all

diagnostic X-ray equipment, use Table 3 to determine increments of filtration required to perform the half-value layer procedure. Make an exposure and record the reading for each total thickness.

Table 3 Highest Design Operating Range

Total Added Filtration. mm Al Below 50 kVp 50-70 kVp Above 70 kVp 0.5 1.0 1.5 1.0 1.5 2.5 1.5 2.5 3.5 2.0 3.5 4.5 The recorded data is plotted on semi-log graph paper and the half-value layer is read directly from the graph.

D. Verification Of Compliance Verify that the half-value layer of the useful beam for a given X-ray tube potential is not less than the values shown in Table 1.


43

Table 4 Half-Value Layers As A Function Of Filtration And Tube Potential Diagnostic Units*

Peak Potential (kVp)

Total Filtration 30 40 50 60 70 80 90 100 110 120 mm Al Typical Half-Value Layers (mm Al) 0.5 0.36** 0.47** 0.58 0.67 0.76 0.84 0.92 1.00 1.08 1.16 1.0 0.55 0.78 0.95 1.08 1.21 1.33 1.46 1.58 1.70 1.82 1.5 0.78 1.04 1.25** 1.42** 1.59** 1.75 1.90 2.08 2.25 2.42 2.0 0.92 1.22 1.49 1.70 1.90 2.10 2.28 2.48 2.80 2.90 2.5 1.02 1.38 1.69 1.95 2.16 2.37*** 2.58*** 2.82*** 3.06*** 3.30 3.0 ------ 1.49 1.87 2.16 2.40 2.62 2.86 3.12 3.38 3.65 3.5 ------ 1.58 2.00 2.34 2.60 2.86 3.12 3.40 3.68 3.95 *For full-wave rectified potential. **Recommended minimum HVL for radiographic units. ***Recommended minimum HVL for fluoroscopes.

Figure 17 Half-Value Determination Graphs

44

XR8 2.13 ACTUAL VERSUS INDICATED SOURCE-TO-IMAGE DISTANCE (SID) REQUIREMENT-Means shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor, to align the center of the X-ray field with respect to th ecenter of the image receptor to within 2 percent of the souce to image distance (SID), and to indicate the SID to within 2 percent. [See 21 CFR 1020.31(e)(1).]

.01 Method I - Direct Measurement Method A. General In order to perform this test it is necessary that the focal spot location be known. B. Equipment Graduated scale. C. Procedure

1. Set the tube unit to an appropriate SID and record this value. 2. Using the graduated scale measure the distance from the plane of the image receptor to the

surface of the table top and record this distance as distance A. 3. Using the graduated scale measure the distance from the tabletop to the bottom of the beam

limiting device and record this distance as distance B. 4. Add aistances A and B to the known focal spot location; this quantity is the actual SID. 5. Multiply the actual SID determined in Step 4 by 2 percent and record. D. Verification and Compliance The indicated value of the SID recorded in step 1 must fall within the value of the actual SID determined in step 4 plus or minus the value determined in step 5.


.02 Method II - Triangulation Method A. General

1. The image of the radiation field on the film must be of uniform density with sharply defined edges.

2. The graduated template is utilized to minimize the amount of error introduced into the measurement and calculation of the SID.

B. Equipment

1. Manufacturer's recommended test stand. 2. Cassettes with film or direct print paper. 3. Graduated template.

C. Procedure 1. Align the tube unit with the image receptor and select an appropriate SID with the normal

operating aids (detents, scales, lights, etc.) provided. 2. Load the cassette and insert into the image receptor. 3. Position the test stand according to the manufacturer's instructions. 4. Load a second cassette and place in the designated position on the test stand. Make certain

that the graduated template is in a position above the second cassette (see Figure 15 Determination Of Sid).

5. Select the proper technique factors, make an exposure, and develop the film or direct print paper.

6. Calculate the magnification factor by measuring the distance between the same two points on the graduated template image on each of the two films. The two points chosen must be as far

45

apart as possible. Divide the larger measurement by the smaller measurement to determine the magnification factor.

7. If the source to test stand film distance is known, calculate the actual SID by multiplying the magnification factor by the source to test stand film distance.

8. If the source to test stand film distance is not known, measure the actual distance4 from the graduated template position to the test stand film plane (distance Z - see Figure 18 Determination Of Sid).

9. Calculate the source to template distance (distance X) using the following formula:

10. Calculate the source to test stand film distance by adding the distance X and the distance Z. Multiply the source to test stand

A/B = X/X+Z or X=AZ/B-A where

A= two points on the graduated template B = magnification of the same two points on the graduated template

46

XR 8-2.14 VISUAL DEFINITION (RADIOGRAPHIC) OR X-RAY LIGHT-FIELD REQUIREMENT - Means shall be provided for visually defining the perimeter of the X-ray field. The total misalignment of the edges of the visually defined field with the respective edges of the X-ray field along either the length or width of the visually defined field shall not exceed 2 percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the X-ray beam. (See 21 CFR 1020.31(d)(2).)

.01 METHOD I - BRH/FDA COMPLIANCE TEST METHOD

A. Equipment Required 1. BRH/FDA compliance test stand (including slide assembly). 2. Four metal marker strips. 3. Plastic cassette, loaded with direct-print paper or film.

B. Procedure 1. Attach the spacer, positioned out of the primary beam to the test stand. Center the stand on the table. Center the source over the stand, assure by the means provided that the axis of the X-ray beam is perpendicular to the plane of the image

receptor, and bring the beam-limiting device down into firm contact with the spacer. Select the MANUAL mode of operation (there must not be a cassette in the cassette holder). 2. Insert the slide assembly, grid side up, into slot 6 of the test stand and the focal spot

assembly into slot 1. Place cassette loaded with direct-print paper or film into the slide assembly.

3. Adjust the collimator such that no part of the light-field intersects any portion of the top of the test stand. (Further collimation to a light-field of less than 15 by 20 centimeters (6 by 8 in) on the slide assembly grid may be desirable to assure that the X-ray field will be fully contained on the direct-print paper or film in the slide assembly). 4. Position the outer edge of each metal strip to correspond with each side of the light-

field. One end of the metal strip shall extend to the center line of the respective grid arm.

5. Select proper technique factors and make an exposure (may require several exposures to obtain 1 R to the direct-print paper). 6. Develop the direct-print paper or film.

C. Verification Of Compliance For determination of misalignment, compare the edges of the X-ray field to the edges of the light-field as defined by the outer edges of the metal strips. On each side of the rectangular fields, measure the separation between the X-ray field and the outside edge on the image of the respective metal strip. Sum these measured separations for opposite sides of the X-ray field to yield a total misalignment in the length and width dimensions. Record the length misalignment and width misalignment, both without regard to sign.

47

D. Calculations Calculate the source-to-image distance (SID) per the following formula (to slot 6) as the indicated source-to-table-top distance minus 4.7 centimeters (1.85in) and record. Calculate 2 percent of this SID and record. Both the length and the width misalignment must be less than 2 percent of SID (to slot 6). 2.5 ___X____ S X + 13.95 2.5X + (2.5) 13.95 = XS (2.5) 13.95 = XS - 2.5X 34.875 = X (S - 2.5) 34.875 X = ------------ S - 2.5 The misalignments are calculated: Length misalignment = L1 + L2 < 2% SID Width misalignment = W1 + W2 < 2% SID Calculate 2 % of the measured SID. Each of the misalignments, length or width, must be less than or equal to 2 % of the measured SID for compliance. NEMA Standard 5-15-1979.

Figure 18 Determination Of Sid

2.5"

S

13.95"

X

BRASS STRIPS

FOCAL SPOT

FOCAL SPOT ASSEMBLYIN SLOT 1

TEST STAND

SLIDE ASSEMBLYIN SLOT 6

TABLE TOP

48

Figure 19 Metal Marker Method

IMAGE OF METAL STRIPS

DOTTED LINE COINCIDESWITH THE OUTER EDGE

OF THE METAL STRIPS ANDIS THE PERIMITER OF

THE LIGHT FIELD

49

.02 METHOD II - METAL MARKER METHOD

A. General The actual versus indicated source-to image distance (SID) test must be performed prior to attempting this test.

B. Equipment 1. Plastic cassette with direct-printer paper or film. 2. Radio-opaque markers.*

*Each marker is approximately 1/32 inch galvanized sheet metal having the dimensions of 1.5 by 1.5 inches.

C. Procedure 1. Adjust the source assembly and the beam-limiting device so that they are approximately

centered over the table and perpendicular to the table top. Then position the beam-limiting device to the SID previously determined and record the indicated value.

2. Insert the cassette and turn on the light-field. **Adjust the beam-limiting device to the next

size smaller than the cassette size being used. **Make a note to record the field size indicated on the dial of the beam-limiting device for the SID being used. 3. Position the outer edge of each metal marker on the tabletop to correspond with each side of

the light-field. 4. Select the appropriate technique factors and make an exposure. 5. Develop film or direct-print paper.

D. Verification Of Compliance For determination of misalignment, compare the edges of the X-ray field to the edges of the light-field as defined by the outer edges of the metal strips. On each side of the rectangular fields, measure the separation between the X-ray field and the outside edge of the image of the respective metal strip. Sum these measured separations for opposite sides of the X-ray field to yield a total misalignment in the length and width dimensions. Record the length misalignment and width misalignment, both without regard to sign. E. CALCULATIONS 2.5 ___X____ S X + 13.95 2.5X + (2.5) 13.95 = XS (2.5) 13.95 = XS - 2.5X 34.875 = X (S - 2.5) 34.875 X = ------------ S - 2.5

50

The misalignments are calculated: Length misalignment = L1 + L2 < 2% SID Width misalignment = W1 + W2 < 2% SID Calculate 2 % of the measured SID. Each of the misalignments, length or width, must be less than or equal to 2 % of the measured SID for compliance. NEMA Standard 5-15-1979.

.03 METHOD III - ALTERNATE TEST STAND METHOD

A. General 1. The image of the radiation field on the film must be of uniform density with sharply defined

edges. 2. The graduated template is utilized to minimize the amount of error introduced into the

measurement of the X-ray field size. 3. The actual versus indicated source-to-image distance (SID) must be determined prior to

performing this test.

B. Equipment 1. Manufacturer’s recommended test stand. 2. Cassettes and film. 3. Graduated template.

C. Procedure 1. Align the tube unit and image receptor and set the SID with the normal operating aids

(detents, scales, lights, etc.) 2. Load cassette and insert into image receptor. 3. Close shutters to a size smaller than that of the cassette placed into the image receptor. 4. Position the test stand in accordance with the manufacturer’s instructions. 5. Energize the field light and record or define the position of the four light field edges as shown

on the graduated template or position four metal markers so that the outer edge of each metal marker corresponds to an edge on each side of the light-field or both.

6. Select proper technique factors, make an exposure, and develop film.

D. Verification Of Compliance 1. Calculate 2 percent of the actual SID and record. 2. Compare the edges of the X-ray field to the edges of the light-field as defined by the outer

edges of the metal markers or by the graduated scale. 3. Measure the distance between the edges of the two fields for each side of the rectangular

fields.

51

4. Arithmetically sum the misalignment of opposite sides, regardless of sign, of the rectangles,

to yield misalignment in each of the two directions. Length misalignment = L1 + L2 < 2% SID Width misalignment = W1 + W2 < 2% SID Both the length and the width misalignment must be less than 2 percent SID as calculated in Step 1.


52

XR 8-2.15 INTENSITY OF LIGHT-FIELD ILLUMINATION REQUIREMENT - When a light localizer is used to define the X-ray field, it shall provide an average illumination of not less than 160 lux (15 footcandles) at 100 centimeters or at the maximum source-to-image distance (SID), whichever is less. The average illumination shall be based on measurements in the approximate center of each quadrant of light-field. (See 21 CFR 1020.31(d)(2)(ii).)

.01 METHOD I - DIRECT TEST

A. General 1. Make certain that all surfaces in the light path are clean. 2. Reduce ambient light level as much as is feasible.

B. Equipment Photometer capable of measuring 160 lux (15 footcandles).

C. Procedure 1. Place the photometer in the tabletop and set the diagnostic source assembly such that the

sensing area of the photometer is at 100 centimeters or the maximum SID, whichever is less. 2. Open the beam-limiting device to assure that each quadrant of the light-field is larger than the

sensing area of the photometer. 3. Refer to the manufacturer’s instructions for proper use of the photometer. 4. Turn on the light localizer. 5. At or near the center of a light-field quadrant, determine the illuminance by subtracting the

ambient light level from the corresponding light level as measured when the light localizer is energized. Do not move the photometer between measurements.

6. Repeat the procedure for the remaining three quadrants. 7. Determine the average illuminance of the four light field quadrants. 8. Record the model number, serial number, and the date of calibration of test instrument.

D. Verification Of Compliance Verify that the average illumination is not less than 160 lux (15 footcandles). NEMA Standard 5-15-79

.02 METHOD II - INDIRECT TEST

A. General 1. This indirect test is feasible after the correlation between light output and voltage is made; the

manufacturer then specifies a voltage to be measured or adjusted, or both. 2. Make certain that all surfaces in the light path are clean and unobstructed.

B. Equipment Digital Voltmeter.

53

C. Procedure 1. Remove trim covers to gain access to the lamp socket. 2. Verify that the specified lamp is in the socket. 3. With the light-field energized, measure the voltage across the lamp socket terminals. 4. Record the voltage measured. 5. Record the model number, serial number and calibration date of the digital voltmeter.

D. Verification Of Compliance The voltage recorded shall be within the tolerances specified by the manufacturer.

NEMA Standard 5-15-1979 NOTE: THE AC VOLTAGE AT THE LAMP SOCKET MUST NOT BE LESS THAN 19.5 VAC RMS.

54

XR 8-2.17 X-RAY FIELD/RECEPTOR CENTER ALIGNMENT REQUIREMENT - Means shall be provided to align the center of the X-ray field with respect to the image receptor to within 2 percent of the source-to-image distance (SID). (See 21 CFR 1020.31(e)(1).)

A. General 1. All exposures taken during this test must have a uniform film density of approximately 1.0. 2. Actual versus indicated SID must be determined prior to performing this test.

B. Equipment Radiographic cassette loaded with film (8 by 10 inches).

C. Procedure 1. Load cassette with film and place into the bucky tray. 2. Assure that the X-ray beam is perpendicular to the image receptor and centered over the

bucky tray. 3. Set the SID to the value determined in the actual versus indicated SID test.

4. Reduce the X-ray field to approximately 6 by 8 inches. 5. Make an exposure and develop the film. 6. To determine as accurately as possible the corners of the image recorded on the film, locate

two points on each of the four sides of the image. Through the two points on each side draw a straight line. These four lines, when extended, intersect making a rectangle which is a close approximation of the actual X-ray field. Draw a diagonal across the image to determine the center of the X-ray image.

7. To determine the center of the X-ray film draw diagonals across the film (the point where

these two lines cross is the center of the film), or fold the film into quarters (the point where the two folds cross is the center of the film).

8. The distance from the film center mark to the image center mark is measured and recorded as

the linear displacement or misalignment or the centers of the X-ray field and the image receptor.

D. Verification Of Compliance Verify that this distance is less than or equal to 2 percent of the SID. NEMA Standard 5-15-1979

55

XR 8-2.18 INDICATION OF X-RAY FIELD SIZE REQUIREMENT - Means shall be provided on the beam-limiting device to indicate field size in the image receptor plane to within 2 percent of the source-to-image distance (SID). (See 21CFR 1020.31(e)(1).)

A. General The actual versus indicated SID test must be performed prior to beginning this test.

B. Equipment A 24-by 30-centimeter or a 10 by 12 inch cassette with film.

C. Procedure 1. Set the SID to the value determined in the actual versus indicated SID test. 2. Center the film cassette in the cassette tray and insert into position. 3. Adjust the field size to 15 by 15 centimeters or 8 by 8 inches by means of the numerical indicators

on the beam-limiting device. 4. Make an exposure and develop film. 5. Measure and record the length and width dimensions of the image.

D. Verification Of Compliance The deviation of any of the recorded dimensions must not exceed 2 percent of the SID in Step 1. NEMA Standard 5-15-1979.

56

XR 8-2.19 POSITIVE BEAM LIMITATION (PBL) REQUIREMENT-Means shall be provided for positive-beam limitation (PBL) which will, at the source-to-image distance (SID) for which the device is designed, either cause automatic adjustment of the x-ray field in the plane of the image receptor to the image receptor size within five seconds after insertion of the image receptor or, if adjustment is accomplished automatically in a time interval greater than five seconds or is manual, will prevent production of x-rays until such adjustments is completed. At SID's at which the device is not intended to operate, the device shall prevent the production of x-rays. [See 21 CFR 1020.31(e)(2).] A. General The PBL requirement must be met if both the beam axis and table angulation are within plus or minus ten degrees of the horizontal or vertical and the film is used in the cassette tray. B. Equipment Large size cassette. C. Procedure 1. Set the source assembly to a SID where the PBL system is intended to operate. 2. Place the largest film cassette with which the system is intended to operate into the cassette tray; do not

insert cassette tray at this time. 3. Turn on the light localizer and adjust the beam-limiting device to the smallest obtainable field size. 4. Insert the cassette tray and measure the time elapsed from the insertion of the cassette tray with

cassette inserted to the adjustment of the x-ray field to the image receptor size. 5. The adjustment must be accomplished within five seconds. 6. If the adjustment is not accomplished within five seconds or the beam-limiting device is of the manual

type, select low-range values of tube potential and tube current and attempt to make an exposure. The production of x-rays must be prevented until the PBL adjustment is completed.

7. Move the source assembly to a Sid where the PBL system is not intended to operate (see manufacturer's specifications) and attempt to make an exposure. Exposures must not be possible.

57

XR 8-2.20 X-RAY FIELD LIMITATION AND ALIGNMENT REQUIREMENT - The X-ray field size in the plane of the image receptor, whether automatically or manually adjusted, shall be such that neither the length nor the width of the X-ray field differs from that of the image receptor by greater than 3 percent of the source-to-image distance (SID) and that the sum of the length and width differences without regard to sign be no greater than 4 percent of the SID, when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor. (See 21 CFR 1020.31(e)(2)(ii).)

.01 METHOD I - FDA/CDRH TEST STAND METHOD

A. Equipment 1. BRH/FDA compliance test stand with accessories. 2. Slide assembly. 3. Plastic cassette containing a sheet of direct-print paper or X-ray film. 4. Ruler. 5. Cassette (preferably 8 by 10 inches or smaller).

B. Procedure 1. Using the means provided, align the source assembly such that the beam axis is perpendicular

to the image receptor. 2. Place the stand on the table. 3. Position the spacer so as not to intersect the primary beam and secure with the pushbutton

connectors. 4. Center the source assembly over the test stand using the means provided, e.g., the light-field

used to define the X-ray field. 5. Bring the source assembly down onto firm contact with the spacer. 6. Center the cassette tray with the source assembly using the means provided, e.g., bucky light. 7. Insert the plastic cassette into the slide assembly. Then insert the slide assembly into slot 5.

(See Figure 12 Brh/Fda Test Stand Showing Chamber Mounting Slots) 8. Center the film cassette in the cassette tray and insert into position. If the positive-beam

limitation will not operate at this SID, raise the source assembly and lock in position at the first operable SID.

9. Make an exposure. Develop the image. Measure and record the length and width dimensions

of the image.

10. Calculate the field size correction factor as the SID/A where:

a. SID is the indicated source-to-image receptor distance, and: b. A is the indicated source-to-tabletop distance less 7.7 inches. Multiply each of the

measured dimensions by the correction factor.

58

X-ray field length at SID under-table image receptor = --------- x (X-ray field length at slot 5) A X-ray field width at SID under-table image receptor = -------- x (X-ray field length at slot 5) A Determine the difference without regard to sign between the corrected length and width dimensions and the corresponding cassette film size dimensions (8 by 10, 5 by 7, etc.). Each of these differences must be less than 3 percent of the SID, and the sum of these differences must be less than 4 percent of the SID.

.02 METHOD II - ALTERNATE TEST STAND METHOD

A. General Prior to performing this test, the magnification factor must be determined in accordance with the X-ray/Light-Field Alignment Test - Method III.

B. Equipment 1. Manufacturer’s recommended test stand. 2. Cassette with film.

C. Procedure 1. Align the tube unit and image receptor and set SID to the value determined in the actual

versus indicated SID test. 2. Insert empty 8 by 10 inch cassette into bucky tray. 3. Position test stand in accordance with manufacturer’s instructions. 4. Load a second cassette and place in the designated position. 5. Select the proper technique factors, make an exposure, and develop film. 6. Measure the length and width of the X-ray image on the film. 7. Multiply each measurement by the magnification factor previously determined.

D. Verification Of Compliance Verify that the X-ray field size in the plane of the image receptor does not differ from that of the image receptor by greater than 3 percent of the SID and that the sum of the length and width differences without regard to sign is no greater than 4 percent of the SID. NEMA Standard 5-15-1979

59

.03 METHOD III - CASSETTE METHOD

A. General This can be used only when capability is provided for overriding positive-beam limitation.

B. Equipment 1. Large cassette with film. 2. Small cassette, empty.

C. Procedure 1. Insert empty smaller cassette into bucky tray. 2. Switch system to the override mode. 3. Remove the smaller cassette and insert the loaded large cassette. 4. Select the proper technique factors, make an exposure, and develop film. 5. Measure the length and width of the X-ray image on the film.

D. Verification Of Compliance Verify that the X-ray field size in the plane of the image receptor does not differ from that of the image receptor (smaller cassette) by greater than 3 percent of the SID and that the sum of the length and width differences without regard to sign is not greater than 4 percent of the SID NEMA Standard 5-15-1979

60

XR 8-2.21 RETURN TO POSITIVE-BEAM LIMITATION (PBL) WITH IMAGE RECEPTOR CHANGE REQUIREMENT-Return to positive-beam limitation (PBL) shall occur with a change in image receptor size. [See 21 CFR 1020.31(e)(2)(iii).] A. Equipment Medium size cassette. B. Procedure 1. Select positive-beam limitation mode. 2. Insert the medium size cassette into the bucky tray and record the field size indication. 3. Collimate down to a field size smaller than the cassette. 4. Remove and reinsert the cassette. C. Verification of Compliance Verify that the system has returned to positive-beam limitation. Record the field size indication and verify that it is equal to the previously recorded field size.

61

XR 8-2.22 KEY LOCK TO POSITIVE-BEAM LIMITATION OVERRIDE REQUIREMENTS-If a capability is provided to override positive-beam limitation, a key shall be required to override the positive mode, and the key shall be captive while the positive mode is overridden. [See 21 CFR 1020.31(e)(2)(v).] A. General This test can be performed only if a capability is provided for overriding positive-beam limitation. B. Equipment None C. Procedure 1. Verify that a key is required in order to select the override mode. 2. Select the override mode using the key. 3. Verify that while in this mode the key is captive.

62

XR 8-2.23 FIELD LIMITATION FOR ONE IMAGE RECEPTOR SIZE REQUIREMENTS- Radiographic equipment designed for only one image receptor size at a fixed source-to-image (SID) shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the x-ray field with the center of the image receptor to within two percent of the SID. [See 21 CFR 1020.31 (f)(2).] A. General 1. Technique factors must be selected to assure a film density of approximately 1.0. 2. Prior to performing this test the actual SID must be determined. B. Equipment 1. Cassette (if required) 2. Film. C. Procedure 1. If applicable, align the x-ray source to the image receptor using the normal operator's procedure. 2. Insert loaded cassette (or advance film), make exposure, and develop film. 3. If the image lies within all four edges of the film (meeting requirement), determine the center of the x-

ray film by drawing diagonals across the film (the point where the two lines cross is the center of the film), of fold the film into quarters (the point where the two folds cross is the center of the film).

D. Verification of compliance 1. All four edges of the x-ray field must lie within the film. 2. The distance between the centers of the x-ray field and the film must be less than two percent of the

SID.

63

XR 8-2.24 FLUOROSCOPIC X-RAY FIELD LIMITATION REQUIREMENT A. Nonimage-intensified Fluoroscopy The x-ray field by nonimage-intensified fluoroscopic equipment shall not extend beyond the entire visible area of the image receptor. This requirement applies to field size during fluoroscopic procedures. B. Image-intensified Fluoroscopy 1. During fluoroscopic procedures, neither the length nor the width of the x-ray field in the plane of the

image receptor shall exceed the visible area of the image receptor by more than three percent of the source-to-image distance (SID). The sum of the excess length and the excess width shall be no greater than four percent of the SID.

2. Compliance shall be determined with the beam axis perpendicular to the image receptor. For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor. [See 21 CFR 1020.32(b).]

.01 Method I-BRH/FDA Test Stand Method A. Equipment 1. BRH/FDA compliance test stand and accessories. 2. Brass or copper attenuation block. 3. Plastic cassette and direct-print paper or redipack film cassette. B. Procedure 1. Position all movable grids and compression cones out of the path of the primary beam. If necessary,

level the table and retract the spot-film carriage. If the system utilizes a television monitor, turn it on and allow time for warm up.

2. Place the test stand in the approximate center of the table. 3. Insert the slide assembly, grid side down, into slot five (see Figure 12 Brh/Fda Test Stand Showing

Chamber Mounting Slots). 4. Place attenuator block on top of slide assembly. 5. Fully open the beam-limiting device. 6. Center the image receptor over the test stand by observing the image of the grid on the image receptor. 7. Bring the imaging assembly down into firm contact with the top of the stand. 8. If using a dual-field image intensifier, e.g., six and nine-inch capability, select the mode of the largest

image magnification, e.g., six mode in this case. 9. Adjust the controls to obtain the best quality image. 10. Insert a plastic cassette containing a sheet of direct-print paper or redipack film cassette into the slide

assembly and make an exposure. 11. At the image output, count the units from the center of the grid to each edge of the image as shown by

lines, A, B, C, and D of Figure 17 Grid. Note that line A passes between grid numbers 1 and 4, B passes between numbers 1 and 2, etc. Record the measurements in order.

12. Develop the film and outline the perimeter of the image. 13. Count the units from the center of the grid to each edge as you did with A, B, C, and D, above. Record

these as A', B', C', and D'.

64

C. Verification of Compliance For compliance of nonimage-intensified systems, A shall be less than or equal to A', B shall be less than or equal to B', C shall be less than or equal to C', and D shall be less than or equal to D'.

Figure 20 Grid

65

For image-intensified systems, determine the source-to-slot distance by adding 18.5 centimeters (7.3 in) to the minimum source-to-skin distance (SSD) determined by the SSD test procedure using the BRH/FDA test stand. Calculate and record three percent and four percent of this distance. Determine the difference, without regard to sign, of A and A', plus the C and C', and D and D' differences must each be less than or equal to three percent of the source-to-slot-5 distance.

.02 Method II-Direct Method A. Equipment 1. Lead foil phantom of copper attenuator. 2. Direct-print paper. 3. One by one-inch steel marker. 4. Four additional metal markers (each marker is approximately 1/32 inch galvanized sheet metal having

the dimensions of 1.5 by 0.5 inches). B. Procedure-Nonimage-intensified Fluoroscope 1. Place the image receptor as close as possible to the tabletop. 2. Open the shutters to the maximum and activate the fluoroscopic tube. 3. Slowly increase the distance between the tabletop and the image receptor. The unit is in compliance if,

at the greatest extension of the image receptor, there is an unilluminated border all around the visible area of the image receptor. No further tests need be made.

4. If the illuminated area expands to the edges of the visible area of the image receptor, lower the image receptor until there is a small unilluminated border.

5. Close the shutters to produce approximately a two-inch wide unilluminated border. Resume increasing image-receptor-to-tabletop distance. The unit is not in compliance if the illuminated area continues to expand.

6. If the illuminated area does not expand, then at the maximum SID, slowly open the shutters to the maximum. The unit is in compliance if the illuminated area does not expand.

C. Procedure-Image-intensified Fluoroscope (Over-the-table Tube, Variable Collimator) This procedure can be used only if the distance from the input phosphor to the tabletop does not change with SID and if the SID is variable. 1. Raise the tube housing to its greatest SID and, if the beam-limiting device is not automatic, close the

shutters to their fullest extent. 2. Activate the tube and slowly increase the field size while observing the monitor. If at the maximum

field size it is obvious that the image of the beam-limiting device is apparent at the edge of the image receptor, no further test need be made. (See Figure 18 Image Receptor).

3. If there is no unilluminated area at any of the edges of the image receptor, lower the tube head until the bottom of the beam-limiting device is at its minimal distance from the tabletop (of 12 inches, whichever is greater). Record this distance.

4. Place a lead foil phantom or copper attenuator on the tabletop and center a loaded cassette in the light field (Figure 20 Over table source).

5. Adjust the light field to give a 5 x 7 inch field on the cassettte and mark the edges with metal markers. 6. Attach a 1 x 1 inch steel marker to the center of the bottom of the beam-limiting device (exact

centering is not necessary). 7. Make an appropriate exposure. 8. Develop the direct-print paper or film and check light and x-ray beam alignment. 9. Measure length of marker image. 10. By similar triangles, determine the source-to-tabletop distance.

66

11. This procedure can continue only if the unit is aligned to radiographic requirements (plus or minus two percent SID). Raise the tube head to maximum SID.

12. Mark the edges of the visible area by placing two radiopaque markers within the light field and parallel to each other and to the edges of the light field.

13. While viewing the markers throughout the image intensifier, activate the tube on and off, adjusting the parallel markers between exposure until the outer edges of the markers are no longer visible (Figure 19 Image receptor (over table source)).

14. Again, turn on the light field and measure the distance from the edges of the light field to the parallel markers.

15. To determine the maximum source-to-tabletop distance, subtract the beam-limiting-device-to-tabletop distance previously determined from the source-to-tabletop distance as previously calculated and add this result to the measured distance from the bottom of the beam-limiting device to the tabletop. Calculate the percent of the SID of the x-ray field that is in excess of the visible area.

16. Place the markers at right angels to the original position and repeat the last three steps. D. Procedure-Image-intensified Fluoroscope (Under-the-table Tube, Variable Collimator) 1. Attach a beam attenuator to the bottom of the image receptor housing. Raise the image receptor

housing to its greatest SID and close the shutters to the fullest extent. Activate the tube and slowly increase the field size while observing the monitor. If at the maximum field size it is obvious that the edge of the image receptor, no further test need be made (SeeFigure 18 Image Receptor).

2. Place markers on tabletop, continue to activate the tube intermittently, and between exposures move the markers to the edges of the visible area of the image receptor (Figure 21 Image receptor (under table source)).

3. Place a 1 x 1 inch steel marker on the tabletop approximately centered between the markers. 4. Center a cassette loaded with direct-print paper or a redipack over the markers. Attach a second

cassette to the bottom of the beam attenuator, adjust the image receptor to 30 centimeters (12 Inches) above the tabletop or the minimum beam attenuator-to-tabletop distance, whichever is greater, and center it over the bottom cassette (Figure 21 Image receptor (under table source)). Measure the distance.

5. Activate the tube for an appropriate exposure of direct-print paper or the redipack film. 6. Develop the direct-print papers or the films. Measure the length of the marker image on the upper

sheet. Calculate the distance from the tabletop to the source by the similar from the tabletop to the source by the similar triangle method. Use this distance as the SID in the next step (7).

7. On the lower sheet measure the distance from the edges of the exposed area to the outer edge of the marker. Calculate the percent of the SID of the x-ray field in excess of the visible area.

8. Place the radiopaque markers at right angles to the original position and repeat the procedure. E. Verification of Compliance For nonimage-intensified fluoroscopy, verify that the x-ray field does not extend beyond the visible area of the image receptor. For image-intensified fluoroscopy, verify that neither the length or width misalignment exceeds the visible area of the image receptor by more than three percent of the SID. The sum of the excess length and the excess width shall be no greater than four percent of the SID.

67

Figure 21 Image Receptor

68

Figure 22 Over table source

Figure 23 Image receptor (over table source)

69

Figure 24 Image receptor (under table source)

Figure 25 Under table source

70

XR 8-2.25 FLUOROSCOPIC SOURCE-TO-SKIN DISTANCE (SSD) REQUIREMENT-The source-to-skin distance (SSD) shall be not less than 38 centimeters (15 inches) on stationary fluoroscopes. [See 21 CFR 1020.32(f).] A. General If the SSD can be measured directly, no further testing is necessary. B. Equipment 1. BRH/FDA compliance test stand with accessories (Figure 11 General Set-Up Brh/Fda Test Stand). 2. Plastic cassette and direct-print paper or redipack film cassette. 3. Brass or copper attenuation block. C. Procedure 1. Position all movable grids and compression cones out of the primary beam. If necessary, return the

table to the horizontal position and raise the spot-film carriage. If the system utilizes a television monitor, turn it on and allow time for warmup.

2. Place the test stand in the approximate center of the table. 3. Insert the slide assembly, grid side down, at slot 3 (See Figure 12 Brh/Fda Test Stand Showing

Chamber Mounting Slots). 4. Place attenuation block on the top of slide assembly. 5. Fully open the beam-limiting device. 6. Center the image receptor over the stand by observing the image of the grid on the image receptor. 7. Bring the image assembly down into firm contact with the spacer bar on the top of the stand. 8. Slide the focal spot assembly, brass side up, into slot 7. 9. Insert the plastic cassette or the redipack film cassette into the slide assembly. 10. Make an exposure assuring proper density on the film or paper. 11. Remove the cassette and develop the direct-print paper or film. 12. Measure the minimum separation of the outside edges of the focal spot strips (See Figure 24 Focal spot

geometry). D. Calculations Calculate the minimum SSD. Minimum SSD (in inches)=((28.25 in square)/(image size in inches - 2.5))-0.4 in Minimum SSD (in centimeters)=((182 cm square)/(image size in inches - 6.4))-1.0 cm E. Verification of Compliance Verify that the SSD is not less than 38 centimeters (15 inches).

71

Figure 26 Under table tubes

UNDER TABLE TUBES

T.V. MONITOR

I1

I2

Y

Z

C

B

A

X

S3

S1S2

INPUT PHOSPHOR

BEAM ATTENUATOR

DIRECT PRINT PAPER

STAND

MARKER

TABLE TOP

FOCAL SPOT

A = MARKER SIZE (PLACED ON THE TABLE TOP)B = MARKER IMAGE SIZE ON DIRECT PRINT PAPERC = BEAM SIZE ON DIRECT PRINT PAPER

72

Figure 27 Focal spot geometry

FILM IMAGEOF OUTSIDESEPARATION OF

6.4 cm (2.5") BRASS STRIPS

FILM

FOCAL SPOT ASSEMBLY

X-RAY BEAM

FOCAL SPOT

28.7 cm11.3"

X

EQUATION: X = 182.3cm²(IMAGE SIZE IN CENTIMETERS - 6.4cm)

EQUATION: X = 28.25(IMAGE SIZE IN INCHES - 2.5)

MINIMUM SSD (IN CENTIMETERS) = X - 1.0cm

MINIMUM SSD (IN INCHES) = X - 0.4"

73

RECORD SHEET This sheet is to be used by the assembler to assure that all points of compliance are covered. It will also serve as a maintenance log. HOSPITAL___________________________________________ ROOM #______________

DATE OF INSTALLATION_______________________________ ASSEMBLER__________

____________________________________________________ ___________

Applicable Installation Requirements Paragraph Date Date Date Date Determination of XR8/2.09

Half-Value Layer

Actual vs. Indicated SID XR8/2.13 Visual Definition of XR8/2.14

X-Ray Light Field

Intensity of Light-Field XR8/2.15 X-Ray Field/Receptor XR8/2.17

Center Alignment

Indication of Field Size XR8/2.18 Positive Beam XR8/2.19

Limitation (PBL) X-Ray Field Limitation XR8/2.20

& Alignment Return to PBL With XR8/2.21

Image Receptor Change

Key Lock PBL Override XR8/2.22 Field Limitation for XR8/2.23

One Image Receptor Size

Fluoroscopic X-ray Field XR8/2.24 Limitation

Fluoroscopic SSD XR8/2.25 Cassette Tray/

Inspection Cleaning

Electrical Cable Inspection

INITIALS:

74

RECORD SHEET NOTES:

75

6. List of Warnings and Notes WARNING!: Failure to follow the procedures in this manual may result in an electrical and/or mechanical safety hazard and failure to meet governmental requirements, as well as damage to the collimator. This unit utilizes a low power (<700 μ watt 650 nm, IEC 60825-1:2001) Class 1 laser to produce an alignment beam.

Radiation Warning for Diagnostic X-Ray Systems X-rays are dangerous to both operator and others in the vicinity unless established safe exposure procedures are strictly observed. The useful and scattered beams can produce serious, genetic or potentially fatal bodily injuries to any persons in the surrounding area if used by an unskilled operator. Adequate precautions must always be taken to avoid exposure to the useful beam, as well as to leakage radiation from within the source housing or to scattered radiation resulting from the passage of radiation through matter. Those authorized to operate, test, participate in or supervise the operation of the equipment must be thoroughly familiar and comply completely with the currently established safe exposure factors and procedures described in publications such as Sub-Chapter J of Title 21 of the Code of Federal Regulations, “Diagnostic X-Ray Systems and their Major Components”, and the National Council on Radiation Protection (NCRP) No. 33, “Medical X-Ray and Gamma-Ray Protection for Energies up to 10 MeV-Equipment Design and Use”, as revised or replaced in the future. Failure to observe these warnings may cause serious, genetic or potentially fatal bodily injuries to the operator or those in the area.

Mechanical/Electrical Warning for Diagnostic X-Ray Systems All of the moveable assemblies and parts of X-ray equipment should be operated with care. Only properly trained and qualified personnel should be permitted access to any internal parts. Live electrical terminals are deadly; be sure line disconnect switches are opened and other appropriate precautions are taken before opening access doors, removing enclosure panels, or attaching accessories. Do not remove the flexible high tension cables from the X-ray tube housing or high tension generator or the access covers from the generator until the main and auxiliary power supplies have been disconnected. When disconnecting high voltage cables, they must be grounded immediately in order to dissipate any electrical charge that may remain on the cables or the tube. Failure to comply with the foregoing may result in serious or potentially fatal bodily injuries to the operator or those in the area. WARNING!: The collimator will not perform properly unless the focal spot to upper swivel ring (x-ray tube mounting ring) distance is 2-7/16” (2.44 inches, 62 mm) + or - 1/32” (.031 inches, 1mm) or 3” + or - 1/32”. (Figure 1) Be sure to include any permanent tube mounting plates in the focal spot to port boss distance to the top of the housing stated in the tube manufacturer’s data.

76

WARNING!: The HUESTIS MEDICAL Collimator is designed to be used with a lead diaphragm or input cone in the plastic port of the X-ray tube. Ensure that there is not any mechanical interference between the collimator entrance cone and the lead diaphragm or cone in the port of the X-ray tube.) If it is found that lead diaphragms or cones require removal or modification, consult the factory. NOTE: FOR CONVENIENCE, TRUNION MOUNTED TUBE HOUSINGS MAY BE ROTATED UPWARD TO FACILITATE MOUNTING OF THE COLLIMATOR. ANOTHER APPROACH WOULD BE TO USE A BOX TO SUPPORT THE COLLIMATOR AND CAREFULLY BRING THE TUBE HOUSING DOWN TO THE COLLIMATOR. WARNING!: Failure to adhere to the above guidelines may result in loosening, damaged screws or mount failure which could result in heavy components falling during use. Incidents of loose system components should be reported immediately to X-ray service personnel for repair. WARNING!: THE LAMP AND HEAT DEFLECTORS MAY BE HOT ENOUGH TO CAUSE SEVERE BURNS. DO NOT TOUCH ANY OBJECT IN THE LAMP AREA WITH BARE SKIN. WARNING!: THE INTENSITY OF LIGHT OUTPUT IS SUFFICIENT TO TEMPORARILY IMPAIR YOUR VISION IF ALLOWED TO ENTER THE EYES DIRECTLY. DO NOT TURN THE LAMP ON WITH THE REAR COVER REMOVED OR MAINTAIN A POSITION IN WHICH YOU CAN SEE NEITHER THE FILAMENT WHEN IT IS OFF, OR ALLOW LIGHT TO DIRECTLY ENTER YOUR FIELD OF VISION WHEN IT IS ON. WARNING!: Disconnect primary power to the collimator power supply any time the covers are to be removed. Note: Do not touch the lamp directly. Use a clean cloth or tissue. This will prevent any oil or contaminate from getting on the lamp, potential burns and premature lamp failure. LAMP USAGE SHALL NOT EXCEED THREE (3) CONSECUTIVE "ON" CYCLES OF 20 SECONDS WITH A COOL DOWN PERIOD OF FIVE (5) MINUTES. FOR LAMP TIMER SETTINGS LONGER THAN 20 SECONDS ONE (1) ON CYCLE IS PERMITTED WITH A 5 (FIVE) MINUTE COOL DOWN.

Caution-use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.

77

7. Appendix

7.1. COMPARISON CHART

The following list is intended to help the installer determine mounting information only, and does not imply

compatibility.

FOCAL SPOT DISTANCE TO

TO COLLIMATOR

MANUFACTURER TUBE HOUSING PORT MOUNTING MOUNTING FLANGE

Eureka Emerald Series 2 - 1/16” 3/8” (.375)

Diamond Series 2 - 1/16” 3/8” (.375)

Sapphire Series 2 - 1/16” 1/4” (.250)

Varian/Eimac B100 2 - 17/64” 11/64” (.171)

B150 2 - 11/64” 17/64” (.265)

B160 2-1/4” 3/16” (.188)

B180 2-1/4” 3/16 (.188)

General Electric Maxiray 100 2 - 5/16” 1/8” (.125)

HRT, MX75 2 - 1/16” 3/8” (.375)

Picker/Dunlee DU - 140 2 - 1/16” 3/8” (.375)

DU - 200 2 - 1/16” 3/8” (.375)

DU - 300 2 - 9/32” 5/32” (.156)

PX - 400 2 - 5/16” 1/8” (.125)

PX - 1300 2 - 3/16” 1/4” (.250)

PX - 1400 2 - 5/16” 1/8” (.125)

Machlett DX40 Series 2 - 1/16” 3/8” (.375)

DX50 Series 2 - 3/16” 1/4” (.250)

DX60 Series 2 - 5/16” 1/8” (.125)

DX70 Series 2 - 5/16” 1/8” (.125)

78

7.2. REPLACEMENT PARTS

PART NUMBER DESCRIPTIONCM-14-016 Faceplate Touchpad, Huestis standard

HW1031 NUT, 6-32 NYLOCKEL884 FCS LAMP HOLDEREL883 FCS LAMP

CM-1016-002 ACCESSORY TRAY RAIL #1 ASS'YCM-16-017 ACCESSORY TRAY RAIL #2CM-16-001 SPRING RETAINER

CM-1016-019 ACCESSORY TRAY RAIL #1 ASS'Y W/ SKIN GD.CM-16-038 ACCESSORY TRAY RAIL #2 W/ SKIN GD.CM-16-039 SPRING RETAINER W/ SKIN GD.CM-16-040 SKIN GUARD LOOP (2 REQ'D)

CM-1011-001 MIRROR FRAME ASSEMBLYCM-13-002 COVER BRACKET L/R, 2 AXISCM-13-023 COVER BRACKET L/R, 3 AXISCM-13-019 BEZEL BRACKETCM-16-002 .060 Thick Mounting SPACERCM-16-003 .25 Thick Mounting SPACER

CM-1016-001 LOCKING RING ASSEMBLYCM-16-006 TUBE MOUNT STD RINGCM-13-025 BOTTOM COVER, 2 AXIS SELCM-13-021 BOTTOM COVER, 3 AXIS SELCM-13-009 REAR PANELCM-16-007 COLLIMATOR MOUNTING RINGCM-14-048 MICROPROCESSOR CONTROLLERCM-12-015 PULLEY WITH BEARINGCM-13-017 BEZEL, 2 AXIS SELCM-13-020 BEZEL, 3 AXIS SELCM-16-010 PLASTIC SHIELD

HW1433 CABLE SPRINGHW1511 MIRROR SPRINGHW1443 LAMP SPRING

CM-14-002 LAMP TIMER PCB ASSY-Single LaserCM-14-038 LAMP TIMER PCB-Dual Laser-Replaces CM-14-002CM-21-002 OPERATION MANUAL, SELECTABLE COLCM-17-006 INPUT CONECM-12-017 SHUTTER CABLE DRIVE

EL872 THERMOSTATAs Required Communications Cable (See Appropriate Section)

79

7.3. LAMP TIMER

Figure 29 CM-14-038 Lamp Timer

Figure 28 CM-14-002 Lamp Timer

80

Figure 30 CM-14-002 Lamp Timer B.O.M.

REFERENCE PART # DESCRIPTION

C1 EL920 220UF 50 V MINI ALUM ELECT

C2,C7,C10,C12,C13 EL921 0.1 UF 50V CAPACITOR

C3 EL922 100 UF ELECTROLYTIC 35V 20% CAPACITOR

C4 EL923 .047 UF 50V CAPACITOR

C5 EL924 0.47UF

C6 EL925 0.01 UF 50V CAPACITOR

C8,C9,C11 EL926 4.7 UF 16V 10% TANT CAPS

D1 EL927 IN 4002 RECTIFIER DIODE

D2 EL928 IN 4148 DIODE

DS1 EL929 L.E.D. GREEN

J1 EL930 5MM X 4 CLAMP SCREW

J2,J3,J4,J5 WM4200-ND 2 PIN HEADER

J6 WM4000-ND 2 PIN HEADER

Q1 EL932 TRIAC, Q015LS

Q2 EL933 TRANSISTOR, PN2222

R1,R2 EL934 22KQ 1/4W 5% RESISTOR

R3 EL935 1.8K OHM 1/4W 5% CARBON FILM RES

R4 EL936 2.7K OGM 1/4W 5% CARBON FILM RES

R5 EL937 510 Q 1/4W 5% RESISTOR

R6 EL938 5.6 OHM 1/4W 5% CARBON FILM RES

R7 EL939 3.9 OHM 1/4W 5% CARBON FILM RES.

R8,R9 EL940 1 KQ 1/4W 5% RESISTOR

R10 EL941 15K OHM 1/4W 5% CARBON FILM RES

R11,R17 EL942 6.8 KQ 1/4W 5% RESISTOR

R12 EL943 100 OHM 1/4W 5% CARBON FILM RES

R13 EL944 100KQ 1/4W 5% RESISTOR

R14 56H-ND 56 OHM 1/2W 5% CARBON FILM RES

R15, R22 360KQBK-ND 360K OHM 1/4W 5% CARBON FILM RES

R16,R18 EL947 47K OHM 1/4W 5% CARBON FILM RES.

R19 EL948 470K OHM 1/4W 5% CARBON FILM RES

R21 270H-ND 270 OHM 1/2W 5% CARBON FILM RES

U1 EL949 OPTOISOLATOR, TRIAC DRIVE M0C3011

U2 EL950 QUAD 2-INPUT NAND

U3 EL951 LM556

U4 EL952 LM305T

Z1 EL953 TRANS VOLT SUPPR 600W 39V BI-D

HS1 EL954 HEATSINK W/PINS 1" TALL TO-220

XQ1, XU4 EL955 SILICONE HEATSINK PAD

PCB CM-14-002M LAMP TIMER CIRCUIT BOARD

81

Figure 31 CM-14-038 Lamp Timer BOM

References Description Manuf Part Number

A1 CM-14-038-M

C1,C14 CAPACITOR ECA-1HHG471

C15 CAPACITOR ECA-1VHG330

C2,C7,C10,C12,C13 CAPACITOR ECU-S1H104MEA

C3,C16 CAPACITOR ECA-1EHG101

C4 CAPACITOR ECU-S1H473MEA

C5 CAPACITOR ECU-S1H474MEB

C6 CAPACITOR ECU-S1H103MEA

C8,C9,C11 CAPACITOR ECA-1HM4R7

D1,D5 DIODE 1N4002

D2,D4 DIODE 1N4148

D3 ZENER DIODE 1N5355B

H1 Washer, Insulation

H2 PHMS-PHILLIPS 4-40X3/8SS

H3 HEX NUT 4-40NUTSS

H4 WASHER, FLAT 04WASHERSS

H5 HEAT SINK PAD Q3-58

HS1 HEAT SINK 531002B02500

J1 TERMINAL ED104/4DS

J2,J3,J4,J5,J6 TERMINAL 22-23-2021

P1 HEADER 22-03-2021

PS1 SHUNT for J6 STC02SYAN

Q1 TRIAC Q2015L5

Q2 TRANSISTOR 2N3904

R1,R2 RESISTOR CFR-25JB-22R

R10,R13 RESISTOR CFR-25JB-100K

R11 RESISTOR CFR-25JB-6K8

R12 RESISTOR CFR-25JB-100R


R15,R20 Resistors-20/40 Sec Time MFR-25FBF-365K

R16,R17,R18 RESISTOR CFR-25JB-47K

R19 RESISTOR CFR-25JB-470K

R3,R4 RESISTOR CFR-25JB-1K8





SN1 SerialNumber Label

U1 OPTOISOLATOR MOC3011

U2 NAND CD4093BCN

U3 TIMER LM556CN

U4 REGULATOR LM350T

U5 REGULATOR NEG LDO LM2990T-5.0

Z1 DIODE TZ P6KE39CAGICT

82

7.4. SCHEMATIC DRAWINGS

83

Figure 32 CM-14-002 Lamp Timer Schematic

84

R16

47KRNR55S

R3 1800

RNR55S

C60.01uF

CK0 4

C13

0.1uFCK0 4

C5

0.47uFCK0 6

12

D2

1N4148

DO-1 5

Vcc

GND

GND

GND

GND

1

23

Q2

2N3904TO-9 2

D4 1N4148DO-1 5

R42700

RNR55S

Vcc

Vcc

ON = LAMP OFF

R18 47KRNR55S

12

R92700RNR55S

J6 ON = 20 SE C

J6 OFF = 40 SE CVDD

VSS

Vcc

R116800RNR55S

R12

100RNR55S

R13100KRNR55S

R10100K

RNR55SR19

470K

RNR55S

R7

3900RNR55S

R15

365K 1%RNR55S

R20

365K 1%RNR55S

R14

56 RNR55SR5510RNR55S

R65600

RNR55S

D1

1N4002DO-2 6

12 C1

470uFRAD-3 94B

GN

D2 IN 3OUT

U4LM350T

TO -22 0 C120.1uF

CK0 4

C2

0.1uFCK0 4

12C9

4.7uF

RAD-19 7

GND 12 R17

47KRNR55S

NC

S WITCH

REMOTE

1

2

4

6

5

3

U1 MOC 30116DIP30 0

P1

22-03-20212 HDR-10 0

12

J5

22-23-2021

2 HDR-10 0

PCB source

AHCM142D5.SC H

Z1

P6KE39CAG ICT

DO-2 6

D5

1N4002 DO-2 6

GN

D

2 IN 3OUT

U5LM2990-5 TO -22 0

Q1

Q2015L5

TO -22 0

R8

10 RNR55S

12 C14

470uFRAD-3 94B

12 C15

33uFRAD-19 7

12 C3

100uFRAD-24 8

12

C114.7uF

RAD-19 7

12 C8

4.7uFRAD-19 7

12

C7

0.1uF

CK0 4

12

C10

0.1uF

CK0 4

1 2

D3

1N5355P78 1F2

1 / LAMP LOW 2 4VAC XRTN

2 , 4 / 24VAC HOT

3 / 24VAC RTN

12

J6

22-23-20212 HDR-10 0

12

J4

22-23-20212 HDR-10 0

1234

J1

ED104/4DSED104 4

24VAC 3, 4

OUT TO LAMP

LASER SUPPLY = ON W/ LAMP

R122

RNR55S

R222

RNR55SC4.047uF

CK0 6

1

23

U2A

4093 1 4DIP30 0

5

64

U2B

1 4DIP30 0

8

91 0

U2C

4093 1 4DIP30 0

1 2

1 31 1

U2D

4093 1 4DIP30 0

1 4 VCC

3 CONT2 THRE6 TRIG4 RSET

5OUT

1DIS

7GND

U3A

NE556 1 4DIP30 0

1 4 VCC

1 1 CONT1 2 THRE

8 TRIG1 0 RSET

9OUT

1 3DIS

7GND

U3B

NE556 1 4DIP30 0

12

J2

22-23-20212 HDR-10 0

12

J3

22-23-20212 HDR-10 0

1 2

Figure 33 CM-14-038 Lamp Timer Schematic

85

Figure 34 CM-14-048 Silkscreen Layer

86

Figure 35 CM-14-048 Schematic Page1

87

Figure 36 CM-14-048 Schematic Page 2

88


89


90

Figure 39 CM-14-021 Control System Assembly Reference

91

Figure 40 CM-14-076 Control System Assembly Reference

92

8. INTERFACE CABLE DETAILS

93

8.1. Selectable/PBL Collimator, Hard Wire Interface/Wiring Schedule

94

8.2. Hard Wire Interface Cable Layout

95

8.3. Hard Wire Interface Extension Cable Wiring Diagram

96

8.4. RS232 Interface Cable Layout & Wiring Diagrams

Figure 41 RJ45 Interface Cable

97

Figure 42 DS9 Interface Cable

98

8.5. RS485 Schematic & Wiring Diagram

PENDING DESIGN

99

8.6. CAN Bus Schematic & Wiring Diagram

PENDING DESIGN

100

BLANK PAGE

101

8.7. Skin guard If the skin guard option was ordered as a factory installed option, the bars will be shipped disassembled due to packaging constraints. Installation is straight forward and the following drawing can be used as a reference. As a field installed option, the standard tray rails must be exchanged for the special rails used only with the skin guard option. Recalibration of the crosshair window should be completed after installation.

102

Declaration of Conformity

103

Huestis Medical 68 Buttonwood Street Bristol, RI 02809 USA

401.253.5500 Fax 401.253.7350

cm-21-002-revc

Documents

revision record

updates revision

software ver

menu section

time of installation

timely installation

end of section

compliance verification