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
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
ii
EU Authorized Representative:
MDSS
Burckhardtstr. 1
D-30163 Hannover
Germany
Phone:+49-511-62 62 86 30
Fax: +49-511-62 62 86 33
iii
iv
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.
a
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.
b
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
c
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
d
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
e
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 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
f
1. INTRODUCTION
Figure 1 Dimensions
1
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.
2
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.
3
CONTROL PANEL GRAPHICS
9 .5 4 0 .0 9 .5
TRA N 0 S I D M L ON G
[Me nu Button 1 ]
[Me nu Button 2 ] [Me nu Button 5 ]
[Me nu Button 6 ]
[Me nu Button 7 ]
[Me nu Button 9 ]
[Me nu Button 8 ]
Figure 2 Control Panel Graphics, Selectable Collimator
4
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.
5
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.
6
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.
7
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.
8
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.
9
Figure 3 Collimator Mounting Assembly
10
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.
11
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.
12
Figure 4 Electrical Connections
13
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.
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
14
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.
15
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.
16
Figure 5 Lamp Removal & Replacement
17
Figure 6 Light Field Adjustment
18
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.
19
Figure 8 Cross-hair Window Adjustment
20
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.
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
alignment beam.
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.
21
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
22
Figure 11 Exploded View Of Laser
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!
23
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?"
24
9 .5 4 0 .0 9 .5
TRA N 0 S I D M L ON G
[Me nu Button 1 ]
[Me nu Button 6 ]
[Me nu Button 7 ]
[Me nu Button 9 ]
[Me nu Button 8 ]
Figure 12 Collimator control panel
25
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?”

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

• Menu Screen - “Long's Offset”

Default value = 80[HEX]
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]
Changing this value will increase/decrease transverse shutter opening throughout the operating
range of the unit.
• Menu Screen – “Fast speed”

Default value = 1; Value range = 1 - 6
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
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
26
• Menu Screen – “Lamp timeout”
Default value = 20
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
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.
• 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
• Menu Screen – “Right hand bucky OK?”

Default value = NO
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
27
Begin Optional Menus
THESE MENU ITEMS NOT AVAILABLE ON SELECTABLE COLLIMATOR
• Menu Screen – “Enable R/F?”

Default value = NO
Affects: PBL-I ONLY
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 Screen - "Mag1's Size"

Default value: C0 HEX
Sets the Iris size inside the Shutter field size in Fluoroscopic Mag 1 Mode
• 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
28
• Menu Screen – “Analog film size?”
Default value = NO
Affects: PBL, PBL-I
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"

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 Screen - "A Film V long 12"

This value is obtained from an external input from the table bucky cassette tray.
• Menu Screen - "A Film V tran 12"

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 Screen - "Table Top Offset"

Default value = 0.0; Value range 0.0 – 10.0
• Menu Screen – “Continuous Afilm?”

Default value = NO
Affects: PBL, PBL-I
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
If YES selected, this option allows Landscape/Portrait resizing via PINS 4 & 8 on
hardwire communication port.
29
• Menu Screen – “Analog SID?”
Default value = NO
Affects: PBL, PBL-I
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:
2) Adjust X-ray device to minimum SID
3) Set input from reference signal:
• 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:
2) Adjust X-ray device to maximum SID
3) Set input from reference signal:
• 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
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).
30
• Menu Screen - "Discrete SID?"
Default value = NO
Affects: PBL, PBL-I
If YES selected, the following menu screen must be configured:
• Menu Screen – “pgmable disc. SID”

Default value = NO
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
Selecting YES displays the tilt angle on the lower line of the display between "TRAN" & "SID"
(not operational, future development)
31
Return to standard user menus
• Menu Screen - Tilt bypass?

Default value = NO
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
If NO selected the following preset film sizes may be deselected to streamline Preset Film Size
Menu:
"Enable 5.0 film?" Default value = YES

• Menu Screen - "Enable pgramble film?"

Default value - NO
If YES selected, allows a custom film size to be entered into the Preset Film Size Menu selection
set:
“Pgm film size X”
“Pgm film size Y”

32
• Menu Screen - “Default SIDs OK? “
Default value = YES
If NO selected, the following preset SID sizes may be deselected to streamline Preset SID Menu:
“Enable 36.0 SID?” Default value = YES
“• Menu Screen - Enable pgmable SID?”

If YES selected, allows a custom SID size to be entered into the Preset SID Menu
selection set:
“Pgm SID size”
• Menu Screen – “Metric display?”

Default value = NO
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
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.
33
9
6
5
8
3
1
Figure 13 Faceplate Button Map
34
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.
35
X-rays are dangerous to both the operator and others in the vicinity unless established safe exposure
procedures are strictly observed.
“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.
36
SPACER
BEAM DEFINING
APERTURE
ALUMINUM
ABSORBER
POSITION
ION CHAMBER
SLIDE ASSEMBLY
Figure 14 General Set-Up Brh/Fda Test Stand
37
SLOT NUMBER
5
CHAMBER
MOUNTS
TRIPOD
HOLES
A
B 8
LEFT SIDE MOUNTING HOLES FOR COMPLIANCE TESTING
Figure 15 Brh/Fda Test Stand Showing Chamber Mounting Slots
38
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).
39
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.
Verify that the radiation output in Step 2 is greater than or equal to 50 percent of the radiation
output in Step 1.
40
DOTTED LINE REPRESENTS
PERIMITER OF LIGHT FIELD
AND CORRESPONDS TO
EDGE OF THE
OUTER EDGE OF
X-RAY FIELD
METAL STRIPS
L1
W2
W1
IMAGE OF METAL STRIPS
ONLY
L2 = 0 (IN THIS
EXAMPLE)
EDGE OF DIRECT PRINT PAPER
Figure 16 Light Field vs. X-Ray Field Error Measurements
41
.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.
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.
42
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
43
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
44
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:
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
10. Calculate the source to test stand film distance by adding the distance X and the distance Z.
Multiply the source to test stand
45
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.
46
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.
FOCAL S POT
FOCAL S POT ASS EMB LY

IN SLOT 1 X
BRAS S STRIP S
2.5"
TE ST STA ND
13. 95"
SLIDE ASS EMB LY

IN SLOT 6
TA BLE TOP
Figure 18 Determination Of Sid
47
DO TTED LINE COINCIDE S
W ITH THE OUTER EDGE
OF THE METAL STRIPS A ND
IS THE PERIMITER OF
THE LIGHT FIE LD
IMA GE OF METAL STRIPS
Figure 19 Metal Marker Method
48
.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.
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
49
The misalignments are calculated:

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.
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.
50
4. Arithmetically sum the misalignment of opposite sides, regardless of sign, of the rectangles,
to yield misalignment in each of the two directions.

Both the length and the width misalignment must be less than 2 percent SID as calculated in
Step 1.
51
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.
Verify that the average illumination is not less than 160 lux (15 footcandles).
.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.
52
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.
The voltage recorded shall be within the tolerances specified by the manufacturer.
NOTE: THE AC VOLTAGE AT THE LAMP SOCKET MUST NOT BE LESS THAN 19.5 VAC
RMS.
53
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.
Verify that this distance is less than or equal to 2 percent of the SID.
54
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.
The deviation of any of the recorded dimensions must not exceed 2 percent of
the SID in Step 1.
NEMA Standard 5-15-1979.
55
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.
56
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.
57
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.
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.
58
.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.
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
59
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.
60
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.
61
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.
62
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'.
63
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
64
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.
65
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.
66
Figure 21 Image Receptor
67
Figure 22 Over table source
Figure 23 Image receptor (over table source)
68
Figure 24 Image receptor (under table source)
Figure 25 Under table source
69
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).
70
UNDE R TAB LE TUBES
I1
INPUT PHOSP HOR
I2
BE AM ATTENUATOR
T.V. MONITOR
DIRECT PRINT PA PER Z
STA ND
MARKER
C S2
S1
B
S3
TA BLE TOP A
FOCAL S POT
A = MARKER SIZE (P LA CE D ON THE TA BLE TOP)

B = MARK ER IMAGE SIZE ON DIRECT PRINT PAPER
C = BE AM SIZE ON DIRECT PRINT PA PER
Figure 26 Under table tubes
71
FILM IMAGEOF OUTSI DE
SEPARATION OF
6.4 cm (2 .5") BRASS STRIPS
FI LM
28 .7 cm
11.3"
FOCAL SPOT ASSE MBLY
X-RAY BEAM
FOCAL S POT
EQUATION: X = (IM AGE SIZ E IN182.3cm²

CENTIM ETERS - 6.4cm)
EQUATION: X = (IM AGE SIZ E28.25

IN I NCHES - 2.5)
MINIMUM SSD (IN CENTIMETERS) = X - 1.0cm
MINIMUM SSD (IN INCHES) = X - 0.4"
Figure 27 Focal spot geometry
72
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:
73
RECORD SHEET NOTES:
74
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.
alignment beam.
X-rays are dangerous to both operator and others in the vicinity unless established safe exposure procedures
are strictly observed.
“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.
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.
75
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.
SETTINGS LONGER THAN 20 SECONDS ONE (1) ON CYCLE IS PERMITTED WITH A 5
(FIVE) MINUTE COOL DOWN.
76
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)
77
7.2. REPLACEMENT PARTS
PART NUMBER DESCRIPTION

CM-14-016 Faceplate Touchpad, Huestis standard
HW1031 NUT, 6-32 NYLOCK
EL884 FCS LAMP HOLDER
EL883 FCS LAMP
CM-1016-002 ACCESSORY TRAY RAIL #1 ASS'Y
CM-16-017 ACCESSORY TRAY RAIL #2
CM-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 ASSEMBLY
CM-13-002 COVER BRACKET L/R, 2 AXIS
CM-13-023 COVER BRACKET L/R, 3 AXIS
CM-13-019 BEZEL BRACKET
CM-16-002 .060 Thick Mounting SPACER
CM-16-003 .25 Thick Mounting SPACER
CM-1016-001 LOCKING RING ASSEMBLY
CM-16-006 TUBE MOUNT STD RING
CM-13-025 BOTTOM COVER, 2 AXIS SEL
CM-13-021 BOTTOM COVER, 3 AXIS SEL
CM-13-009 REAR PANEL
CM-16-007 COLLIMATOR MOUNTING RING
CM-14-048 MICROPROCESSOR CONTROLLER
CM-12-015 PULLEY WITH BEARING
CM-13-017 BEZEL, 2 AXIS SEL
CM-13-020 BEZEL, 3 AXIS SEL
CM-16-010 PLASTIC SHIELD
HW1433 CABLE SPRING
HW1511 MIRROR SPRING
HW1443 LAMP SPRING
CM-14-002 LAMP TIMER PCB ASSY-Single Laser
CM-14-038 LAMP TIMER PCB-Dual Laser-Replaces CM-14-002
CM-21-002 OPERATION MANUAL, SELECTABLE COL
CM-17-006 INPUT CONE
CM-12-017 SHUTTER CABLE DRIVE
EL872 THERMOSTAT
As Required Communications Cable (See Appropriate Section)
78
7.3. LAMP TIMER
Figure 28 CM-14-002 Lamp Timer
Figure 29 CM-14-038 Lamp Timer
79
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
Figure 30 CM-14-002 Lamp Timer B.O.M.
80
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
Figure 31 CM-14-038 Lamp Timer BOM
81
7.4. SCHEMATIC DRAWINGS
82
Figure 32 CM-14-002 Lamp Timer Schematic
83
J1 24VAC 3, 4
4
3
2 1 / LAM P LOW 2 4VAC XRT N
1
E D104/ 4DS
ED104 4
J4 J6
2
OUT TO LAMP
C14 C15
2 2
1 1
470uF 33uF
1
RAD-3 94B RAD-19 7 2 HDR-10 0 2 HDR-10 0
D5 R8 D3 22-23-2021 22-23-2021
GND
1 2 2 IN OUT 3
1N4002 DO-2 6 10 1N5355 L ASER SUPPLY = ON W/ LAMP

RNR55S TO -22 0
P78 1F 2 LM 2990-5 U5
2 , 4 / 24VAC HOT
LM350T U4
D1 R14 Vcc R2 R1
P6KE39CAG ICT 22 22 U1 MOC 3011
2 IN OUT 3 D4 1N4148 6DIP30 0
GND
DO-1 5
4 3
1N4002 56 RNR55S RNR55S RNR55S
DO-2 6 TO -22 0 R5 C12 2700 C4 2
C1 Z1 C2 R4 5
2
510 0.1uF RNR55S .047uF 1
RNR55S 2 HDR-10 0 GND
CK0 4
Q1 CK0 6 6
RAD-3 94B 0.1uF J5
1
470uF DO-2 6
CK0 4
2
R6 1 Q2015L5
ON = LAMP OFF
5600 TO -22 0 R3 1800
3 / 24 VAC RT N RNR55S 22-23-2021

RNR55S
Vcc
P1 J6 ON = 20 SE C
VDD Vcc Vcc GND
J6 OFF = 40 SE C
1
2
22-03-2021
2 HDR-10 0
R18 47K
2
RAD-19 7
R11 R13 C9 RNR55S
6800 100K 4.7uF
2
R9 U2A R17 U3A R16 R15 R20
1
RNR55S
S WITC H RNR55S 1
2700 3 47K 14 VCC
2
J2 RNR55S 2 RNR55S OUT 5 47K 365K 1% 365K 1%
GND 3 CONT
1
RNR55S RNR55S RNR55S
1 D2 4093
2 THRE DIS 1
2 1 4DIP30 0 6 T RIG
1
R10 U2B 4 RSET GND 7
1N4148 5
1
22-23-2021 C6 100K
4 C7
2 HDR-10 0 0.01uF DO-1 5 6 NE556 1 4DIP30 0
2
RNR55S
J3 C5 R19 0.1uF C3
CK0 4 1 4DIP30 0
U2C
2
1
2 8 470K
C8 100uF
1
CK0 4
10 RAD-24 8
0.47uF
CK0 6
9 RNR55S U3B Q2 4.7uF
22-23-2021 R12
1
3
2 HDR-10 0
4093
14 VCC R7 RAD-19 7
1 4DIP30 0 9 1
100 C13 U2D 11
OUT
CONT
REMOTE RNR55S 12 12 THRE DIS 13 NC
3900
PCB s ource
2
0.1uF 11 8 T RIG
13 10 7 RNR55S
CK0 4 RSET GND
2N3904
1
4093
C10 T O-9 2
VSS 1 4DIP30 0 C11 NE556 1 4DIP30 0
GND
2
4.7uF 0.1uF
1
RAD-19 7
CK0 4
GND AH CM142D5.SC H
Figure 33 CM-14-038 Lamp Timer Schematic
84
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
88
89
Figure 39 CM-14-021 Control System Assembly Reference
90
Figure 40 CM-14-076 Control System Assembly Reference
91
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
Figure 41 RJ45 Interface Cable
96
Figure 42 DS9 Interface Cable
97
8.5. RS485 Schematic & Wiring Diagram
PENDING DESIGN
98
8.6. CAN Bus Schematic & Wiring Diagram
PENDING DESIGN
99
BLANK PAGE
100
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.
101
Declaration of Conformity
102
Huestis Medical
68 Buttonwood Street
Bristol, RI 02809 USA
401.253.5500
Fax 401.253.7350
103

CM 21 002 RevC

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CM 21 002 RevC

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Huestis Medical

Part Number: CM-21-002

TO: INSTALLERS, SERVICE PERSONNEL, AND TECHNICIANS

Altitude 0 to 10,000 feet (0 to 3048 meters) (operating)

Input Cone Protector

To Remove Input Cone Protector:

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

1.1. YOU HAVE LEGAL OBLIGATIONS

[Me nu Button 2 ] [Me nu Button 5 ]

[Me nu Button 3 ] [Me nu Button 4 ]

Figure 2 Control Panel Graphics, Selectable Collimator

1.3.1. Control Panel Display

1.3.2. Menu Selection Buttons

1.3.3. Manual Override Controls

1.3.4. Field Light Activate

1.4. RADIATION AND MECHANICAL/ELECTRICAL WARNING

Radiation Warning for Diagnostic X-Ray Systems

Mechanical/Electrical Warning for Diagnostic X-Ray Systems

1.5.1. Focal Distance X-ray Tube:

1 - ¼ inch (0.25”) spacer

1.5.2. Leakage radiation:

1.5.3. Inherent Filtration and Half-Value Layer:

Checkout should also occur if any of the following conditions occur:

1.6.1. Cleaning & Disinfecting

1.7. COMPLIANCE REQUIREMENTS

2.1. COLLIMATOR MOUNTING (Figure 3 Collimator Mounting Assembly)

WARNING!: The HUESTIS MEDICAL Collimator is designed to be used with a lead

IMPORTANT: If the optional 90° rotation detent assembly is ordered factory

NOTE: FOR CONVENIENCE, TRUNION MOUNTED TUBE HOUSINGS MAY BE

2.2.1. Collimator Electrical Requirements

3.1. FIELD PROJECTION LAMP ADJUSTMENT & REPLACEMENT

WARNING! THE LAMP AND HEAT DEFLECTORS MAY BE HOT ENOUGH TO

WARNING! THE INTENSITY OF LIGHT OUTPUT IS SUFFICIENT TO

WARNING! DISCONNECT PRIMARY POWER TO THE COLLIMATOR POWER

3.1.1. Field Lamp Replacement

WARNING! DO NOT TOUCH THE LAMP DIRECTLY. USE A CLOTH OR TISSUE.

5. Replace the rear lamp cover on the collimator.

Measure and confirm SID at 40” to film.

Ensure that the X-ray beam is perpendicular to the image receptor.

ALTERNATE PROCEDURE #1 FOR PBL-I COLLIMATOR

ALTERNATE PROCEDURE #2 FOR PBL-I COLLIMATOR

Figure 7 Rad/Fluoro Switch Contact Key

3.4. CROSS-HAIR WINDOW ADJUSTMENT

Tighten the screws and confirm alignment.

WARNING! THE LAMP AND HEAT DEFLECTORS MAY BE HOT ENOUGH

WARNING! THE INTENSITY OF LIGHT OUTPUT IS SUFFICIENT TO TEMPORARILY

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.

Figure 9 Laser Bucky Line Projections

Figure 10 Reference View Of Laser

3.6. BUCKY CENTERING LASER LIGHT LINE USE

Collimator Software Configuration Procedure

[Me nu Button 2 ] [Me nu Button 5 ]

[Me nu Button 3 ] [Me nu Button 4 ]

Figure 12 Collimator control panel

User Calibration Menu Options

• Menu Screen – “Huestis Medical Configuration Menu” (Opening Screen)

• Menu Screen – “Configuration Menu Exit?”

• Menu Screen – Software part number and version information

• Menu Screen - “Long's Offset”