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PINNACLE Manual Complete

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0% found this document useful (0 votes)
2K views78 pages

PINNACLE Manual Complete

pinnacle
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 78

 Progeny, Inc.

1407 Barclay Blvd.

EUREKA
Buffalo Grove, IL 60089
U.S.A.

Tel. (847) 850-3800


Fax (847) 850-3801

LINEAR MC150 ™

PINNACLE

Installation
Operation
and Maintenance

00-02-1566
Copyright  2000 Progeny, Inc. Corp.
Rev. H ECN: P1095
November 2005

November 2005 MC150 PINNACLE


PROGENY, INC.
Suppliers of Eureka Collimators and Cables

INSTALLATION ADVISORY

TO: INSTALLERS, SERVICE PERSONNEL, AND USERS OF X-RAY SYSTEMS

COLLIMATOR MOUNTING INFORMATION


(See following pages if unit includes the “Locking Collar” feature)

In order to ensure a safe and secure mounting of this collimator to the X-ray tube housing, the following
installation guidelines must be followed:

1. Two different length screws are provided in the cloth bag 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.

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 mounting surface located on the
tube housing port. 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. The screws provided have a Nylok patch, as vibration resistant
mounting screws are strongly recommended.

Verify that the collimator mounting screws engage the housing by at least five (5) threads
when used with the any required collimator spacer plate(s).

4. In order to fasten the Collimator to the Tube Housing, It is necessary that the four (4)
collimator detent ball plungers (located on the top of the collimator) are aligned with the
detent holes located on the collimator tube mounting plate (i.e. collimator is mounted in
either the 0, -90, or +90 degree swivel position).

NOTE: It is much easier to mount the collimator when the tube is inverted (upside-down) or
if the collimator is placed on the table top and the tube is lowered onto it.

5. Carefully support the collimator in place and attach the clamping ring. The hinge of the
clamping ring must line up with the pin in the lower mounting ring. Securely fasten the #6-
32 socket head cap screw locking the collar halves in place. Use only the provided
Collar Locking Screw (26-00752), do not replace with other hardware. In addition
install two (2) Collar Locks (70-10038), which provides a fail-safe for the Collar/Screw
Assembly.

6. After mounting the collimator and/or performing any service to it or the tube housing, inspect
the fit of the collimator and the tube housing. Grasp and attempt to move the collimator and
then the tube housing assembly while inspecting for loose joints or gaps between the
tube/collimator assembly, as well as other tube mounting areas. If a problem is found
consult factory personnel.

7. It is strongly recommended that a periodic inspection (at least every 12 months) should be
made to ensure mounting integrity.

WARNING
Failure to adhere to the above guidelines may result in loosening, damaged screw 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.

November 2005 MC150 PINNACLE


TABLE OF CONTENTS
SECTION PAGE

1.0 OPERATION…………………………………………………………… 1-4


1.1 User Keypad Input Mode……………………………………………………… 1-5
1.2 Introduction…………………………………………………………………….. 1-6
1.3 You have Legal Obligations…………………………………………………... 1-6
1.4 Background…………………………………………………………………….. 1-6
1.5 General Specifications………………………………………………………… 1-7
1.6 Advanced Features……………………………………………………………. 1-8
1.7 Radiation and Mechanical / Electrical Warning…………………………….. 1-8
1.8 Compatibility……………………………………………………………………. 1-9
1.9 Maintenance……………………………………………………………………. 1-10
1.10 European Representative…………………………………………………….. 1-10
2.0 INSTALLATION……………………………………………………………….. 2-1
2.1 Unpacking………………………………………………………………………. 2-3
2.2 Equipment Supplied…………………………………………………………… 2-3
2.3 Collimator Mounting…………………………………………………………… 2-3
2.4 Wiring to a System (Non-Progeny) Provided 24 Volt AC Power Supply… 2-6
2.5 Mounting and Wiring of Progeny Power Supply……………………………. 2-7
2.6 Calibration……………………………………………………………………… 2-11
2.7 Voltage Adjustment for Field Size Feedback Potentiometers …………… 2-13
3.0 OPERATIONAL CHECKOUT PROCEDURE……………………………… 3-1
4.0 ADJUSTMENT PROCEDURES…………………………………………….. 4-1
4.1 Field Projection Lamp and Mirror Adjustment……………………………… 4-3
4.2 Cross-Hair Window Adjustment……………………………………………… 4-4
4.3 Bucky Centering Light-Line Adjustment…………………………………….. 4-4
4.3 Bucky Light-Line Laser……………………………………………………….. 4-5
4.4 Long and Cross SID Indicator Adjustment………………………………….. 4-8
5.0 COMPLIANCE VERIFICATION……………………………………………… 5-1
5.1 Verification Test to be Performed…………………………………………….. 5-3
XR8/2.09 Determination of Half-value Layer……………………………………………. 5-4
XR8/2.14 Visual Definition of X-ray Light-Field…………………………………………. 5-9
XR8/2.15 Intensity of Light Field Illumination……………………………………………. 5-14
XR8/2.17 X-ray Field Receptor Center Alignment……………………………………… 5-16
XR8/2.18 Indication of Field Size…………………………………………………………. 5-17
XR8/2.20 X-ray Field Limitation and Alignment…………………………………………. 5-18
Record Sheet……………………………………………………………………. 5-22
6.0 THEORY OF OPERATION……………………………………………………. 6-1
6.1 Mechanical Operation………………………………………………………….. 6-3
6.2 Electrical Operation…………………………………………………………….. 6-3
7.0 REPLACEMENT PARTS LIST……………………………………………….. 7-1
8.0 APPENDIX………………………………………………………………………. 8-1

LIST OF ILLUSTRATIONS
SECTION FIGURE PAGE

1.0 1-1 Front Panel Indicators and Collimator Operations……………….. 1-3


2.0 2-1 Component Identification……………………………………………. 2-2
2-2 Skin Guard Installation………………………………………………. 2-5
2-3 Collimator Mounting Dimensions…………………………………… 2-5
2-4 Wiring when using a 24 Volt AC Source Provided by X-ray System 2-6
(Non Progeny)…………………………………………………………
2-5 Power Chassis Outline………………………………………………. 2-8
2-6 Interconnect Wiring when Using Eureka Power Supply…………. 2-8

(i)
November 2005 MC150 PINNACLE
LIST OF ILLUSTRATIONS (Continued)

SECTION FIGURE PAGE

3.0 3-1 Light Field / X-ray Field Congruency Test Measurement………… 3-4
4.0 4-1 Lower Case Removal………………………………………………… 4-2
4.2 Bucky Light-Line Laser Projections………………………………… 4-7
4-2 Lamp and Bucky Light-Line Adjustments……………………………. 4-9
5.0 5-1 FDA Compliance Test Stand………………………………………… 5-2
5-2 Compliance Stand Detail…………………………………………….. 5-2
5-3 Light Field vs. X-ray Field Error Measurements…………………… 5-7
5-4 Calculation Example………………………………………………….. 5-11
5-5 Metal Marker Method…………………………………………………. 5-11
5-6 Half-value Layer Determination Graphs…………………………….. 5-8

LIST OF TABLES

SECTION TABLE PAGE

5.0 5-1 Minimum Beam Quality Requirements………………………………. 5-4


5-2 Aluminum Equivalent of Primary Beam Total Filtration……………. 5-5
5-3 Highest Design Operating Range…………………………………….. 5-7
5-4 Half-value Layers as a Function of Filtration and Tube…………….. 5-8
Potential for Diagnostic Units…………………….

(ii)

November 2005 MC150 PINNACLE


SECTION 1.0

INTRODUCTION

(1-1)

November 2005 MC150 PINNACLE


This product has been tested by Underwriter’s Laboratories in conformance with standards set
forth by UL 2601-1, CAN/CSA – C22.2 No. 601.1-M-90, and IEC 601-2-32. It has been found
to comply with these standards and, therefore, bears the above “Recognized Component”
symbol for UL and UL-C.

UL File No. E181750

Progeny, Inc. is registered to ISO9001, EN46001, and the Medical Device Directive 93/42/EEC
Annex II by SGS Yarsley, Ltd.

(1-2)
November 2005 MC150 PINNACLE
FRONT PANEL INDICATORS & COLLIMATOR OPERATION

FlipRotation Key ON Indicator

Cassette size LED


selectors indication selectable
for English or Metric

Display of field
size

Display of SID

This knob controls


LAMP SID Key
the cross shutters selects 40” or 72”

Push-button to
start timed light
field display

FIGURE 1

Keypad operation Manual operation

• Press SID key to select 40” SID (100cm) • Press the lamp push-button to activate the light
or 72” SID (180cm). field. Adjust the shutters to size not larger than
the film to be used.
• Press cassette size selectors to recall a
cassette size stored in memory. • Center light field over cassette or anatomical area
to be exposed.
• Press rotation key to flip cassette 90° degrees.
Eg: 14x17 to 17x14.

• Press the “Lamp” push-button to activate


light field. Verify light field aperture with
cassette size to be used.

(1-3)
November 2005 MC150 PINNACLE
SECTION 1.0

OPERATION

The MC150 Pinnacle is a motorized manual collimator. The Pinnacle has motors to move the
shutters, buttons to select the field size, a button to select SID, a digital display of field size, and
a digital display of SID. Figure 1, shows the front panel of the Pinnacle, which contains these
features.

The user operates the unit as a manual collimator. The user opens the collimator shutters to
the desired size by rotating the knobs on the front panel. The user will view the field size on the
collimator front panel via the digital display. The default SID scale used will be 40 inch SID
(100cm). If the user requires a 72 inch SID (180cm) scale, pressing the SID button will cause
the display scale to alternate between 40 inches (100cm) and 72 inches (180cm).

In addition, the user may utilize the motors by pressing the arrow keys which will cause the
display to change the field size to one of the stored values. The stored field sizes are listed in
Table 1. The two arrow keys are referred to as up and down. When the user presses the up
key, the next largest field size in memory is displayed. When the user presses the down key,
the next smallest field size in memory is displayed.

The stored sizes are rectangular in shape. In every case in which the size selected is a
rectangle, the longer dimension of the rectangle is displayed in the longitudinal direction and the
smaller dimension in the cross table direction. If the user requires the field size to be rotated by
90 degrees, the circular arrow flip key must be pressed.

TABLE 1

FIELD SIZE

Inches Metric (cm)

14 x 17 35 x 43
14 x 14 35 x 35
11 x 14 30 x 35
10 x 12 24 x 30
8 x 10 18 x 24

The collimator can display either inches or metric (cm’s). The default scale is set with an
internal switch which determines the display when power is turned on. Metric and English field
sites can be stored as valid sizes at the same time in memory (if a location uses both English
and metric cassettes). If both inches and metric preset field sizes have been stored, when
selecting from an English scale to a size in metric scale, the collimator will automatically switch
between English to Metric display. In order for the Pinnacle to change the default condition, the
jumper, labeled JP2 on the Pinnacle control PCB must be set with a shunt in the CM position.
This can only be done by a technician after removing power, the interconnect cable, and the
covers. Then, once reconnected and with the covers in place, with power turned on, the
collimator will display field size in metric (cm’s). When in metric display, the SID scales used
will be 100 and 180 cm.

(1-4)
November 2005 MC150 PINNACLE
1.1 KEYPAD OPERATION

When the SID key is pressed, the software will toggle the SID display, i.e., if 40 is displayed
before the key press, 72 will be displayed, and vice versa. Following this, the software will
compute the size of the field on the new SID scale.

If the ROT key is pressed, the field display will alternate values from cross to long, e.g., 14 x 17
will now display 17 x 14.

If either the UP or DOWN key is pressed, the next stored preset field sizes is displayed.

The keypad delays one second before completing an action to allow the operator to scroll
through the preset field sizes without resizing occurs.

(1-5)

November 2005 MC150 PINNACLE


1.2 INTRODUCTION
This product has been tested by Underwriter’s Laboratories in conformance with standards set
forth by UL 2601-1, CAN/CSA – C22.2 No. 601.1-M-90, and IEC 601-2-32. It has been found
to comply with these standards and, therefore, bears the above “Recognized Component”
symbol for UL and UL-C.
UL File No. E181750
Progeny, Inc. is registered to ISO9001, EN46001, and the Medical Device Directive 93/42/EEC
Annex II by SGS Yarsley, Ltd.
MANUAL OPERATION

1.2 INTRODUCTION
This manual contains information for the assembly, installation, adjustment, testing and
maintenance of the MC150 PINNACLE collimator manufactured by Progeny, Inc.

1.3 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 FDA Performance Standards 21 CFR Sub-Chapter J, Part 1020.
Those who assemble or service beam limiting devices must follow the instructions of the
original manufacturer and process the FD-2579 Assemblers Report where applicable.
You assume responsibility for compliance of this product if you fail to follow the original
manufacturer’s instructions or modify any component which affects radiation safety.
The FDA (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 be provided
by the manufacturer. The instructions include a requirement to record key data to
demonstrate at a later time that all tests were performed and that the equipment was left
in full compliance with the standards.
As an assembler, you must perform these tests for the applicable requirements at the
time of installation and following any repairs which could alter the performance.
A Compliance Data Log is provided in this manual to record the results of the tests.

1.4 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.

(1-6)

November 2005 MC150 PINNACLE


In “collimating” a beam to a given size and shape, a geared pair of lead shutters are
moved symmetrically into the beam to absorb the unwanted portion of the emerging
beam. A second geared pair of shutters are positioned at right angles to the first pair,
and again are moved symmetrically into the beam. In this manner, a continuously
variable square/rectangular beam is formed.
The landing area of the beam will contain a radiographic 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.

1.5 GENERAL SPECIFICATIONS - Model MC150 PINNACLE

The MC150 PINNACLE collimation system from EUREKA includes all features
required for diagnostic excellence.

APPLICATIONS................. For general purpose radiographic units and special purpose


radiographic units.

MAXIMUM kVp................... 150 kVp.

OUTER DIMENSIONS....... 18cm x 20.5cm x 30cm or 7.1 inches x 8.1 inches x 11.8 inches

NET WEIGHT..................... 8.2kg or 18.04 lbs. (approximately)

PROJECTION LAMP......... Quick change, pre-aligned quartz halogen lamp. Light output
more than 160 Lux at 100 cm.

LAMP TIMER..................... Push button type, 25 seconds approximately.

POWER SUPPLY.............. 24 VAC +/- 10% at 8 Amps

PROJECTED FIELD SIZE.. Square or rectangular pattern continuously variable from closed
to 43cm by 43cm at 86cm SID or 17 inches by 17 inches at 36
inches SID
CONE Optional
TRACK.....................
SWIVEL MOUNT................ Standard

BUCKY LIGHT LINE........... Standard

SKIN GUARDS................... Optional, to be attached for Mobile operation

FILTRATION....................... 2.0 mm (Min.) Aluminum equivalent at 100kVp. Low filtration


mirror bracket available from Progeny (1.00 mm minimum
aluminum equivalent).

INDICATIONS..................... Cassette size and SID displays for long and cross shutters
calibrated for 100cm and 180cm and 40 in and 72 in SID’s.
(1-7)

November 2005 MC150 PINNACLE


1.6 ADVANCED FEATURES

The MC150 PINNACLE collimator system incorporates features required for diagnostic
convenience...
• Front panel displays to show projected field dimensions at 100cm, 180cm, 40
inches, and 72 inches SIDs.
• Bright centering light-line which extends from the front of the extended
cassette tray across the table-top to beyond the center of the patient, completely
eliminates the need for mechanical “pointers”.
• Swivel mount standard for angulated positioning.
• Keypad to select and store cassettes sizes.

An indicator lamp in the “light” switch will indicate when the field projector bulb requires
replacement. A spare lamp is provided inside the lamp housing and is easily replaced by the
owner/operator.

1.7 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.
(1-8)

November 2005 MC150 PINNACLE


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.

1.8 COMPATIBILITY

The MC150 PINNACLE collimator is compatible and can be adapted for use with
X-ray tube/housing assemblies that meet all of the following factors:

1. Focal Distance of X-ray Tube:

The focal spot to collimator mounting flange distance must be 2.44” + .03” (6.0 cm + .
08 cm). Four (4) spacers are supplied for adaptation:
1-.25” (0.635 cm) spacer
2- 6” (0.152 cm) spacer

Use any of the above combination to achieve the requirements.


If the large spacer is used, be sure to orient the sides per the labels attached to the
spacer.

Leakage Radiation:

Maximum leakage radiation from the X-ray tube/housing assembly must not exceed 50
mR/hr at 100 cm (40 inches) at specified leakage technical factors. This collimator is
compatible with all x-ray tube housing assemblies having leakage technique factors of
150 kV and 4 mA.

3. Inherent Filtration and Half-Value Layer:

The Eureka MC150 PINNACLE collimator has a minimum value of 2.0 mm aluminum
equivalence at 100 kV. 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 kV must be 2.7
mm Al. A low filtration mirror bracket (1.0 mm Aluminum equivalent) is available
from Progeny for use with X-Ray tubes with high inherent filtration.

Application:

The intended application is for general purpose radiographic equipment, including


tomographic and chest applications. Maximum tube rating must be 150 kV or less.

Installation:

Must be made with supplied hardware, including mounting flange, spacers (as
required), four ¼ - 20 bolts or four M6 x 16 bolts spaced on a 3.625 diameter bolt
center.

(1-9)

November 2005 MC150 PINNACLE


1.9 MAINTENANCE

The Collimator system must be properly maintained to assure both compliance with FDA
regulations and useful life.
Preventive maintenance is to be performed once every twelve months. This
includes inspection and lubrication of the collimator mechanism.
If collimator does not spin freely and smoothly, remove it from tube. Clean all surfaces
of collar and mounting flanges. Apply lubriplate or similar grease. Mount collimator onto
tube. If shutters seem too loose or too tight when turning knobs, remove the front
bezel cover and adjust the knob tension bar as required. This can be done using an
allen key to turn screws in bar.
Checkout should also occur if any of the following conditions occur:
• Lamp replacement
• Electronic component failure, replacement or calibration performed
• When collimator is removed from tube/housing assembly
• When collimator has been subjected to external damage

Refer to Section 5.0 for collimator CHECK-OUT procedure.

1.10 EUROPEAN REPRESENTATIVE

Progeny, Inc. has contracted with the following company to act as a European
Authorized Representative relative to the requirements of EN46001 and the Medical
Device Directive:

CE Partner 4U
Esdoornlaan 13
3951DB Maarn
The Netherlands

Phone: +31.343.442.524
Fax: +31.343.442.162

European customers should direct any customer complaints or requests for product
technical files to CE Partner 4U.

(1-10)

November 2005 MC150 PINNACLE


SECTION 2.0
INSTALLATION

(2-1)

November 2005 MC150 PINNACLE


INTERCONNECTING CABLES SKIN GUARD AND MOUNTING
AND POWER SUPPLY UNIT HARDWARE (OPTIONAL)
(OPTIONAL)

MANUAL LINEAR MC150 COLLIMATOR

CONE TRACK SPACERS AND MOUNTING HARDWARE


(OPTIONAL)

COMPONENT IDENTIFICATION
FIGURE 2.1

November 2005 MC150 PINNACLE


(2-2)
2.0 INSTALLATION

2.1 UNPACKING

Carefully unpack the equipment and check for damage incurred during shipment. Any
damage should be referred to the agency that delivered the product.

2.2 EQUIPMENT SUPPLIED

Refer to Figure 2-1 for component identification

• MC150 PINNACLE Collimator


• Spacers and mounting hardware
• Power supply unit (when supplied) and wiring cables.
• Packet containing Instruction Manual, Assembler’s Report FD -2579,
Returned Goods Authorization/Service Report

2.3 COLLIMATOR MOUNTING

2.3.1 Determine the collimator mounting surface to focal spot distance from the datas
supplied with the X-ray tube (do not rely on an inscribed mark on the tube
housing).

Note: The collimator will not perform properly unless the focal spot to upper
swivel ring distance is 2-7/16” (2.44 inches, 62 mm) +/- 1/32” (.031 inches, 1 mm).
Be sure to include any permanent mounting plates in the focal spot to port boss
distance stated in the tube manufacturer’s data.
Note: The MC150 PINNACLE is designed to be used with a lead diaphragm or
cone in the plastic 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 to the
collimator mounting surface to obtain a focal spot to collimator mounting flange distance
of 2-7/16” (2.44 inches, 62 mm) +/- 1/32” (.031 inches, 1 mm). Refer to Figure 2-3.
Remove the upper swivel ring from the collimator by removing the 6-32 socket head cap
screw and opening the clamp ring.
In order to insure a safe and secure mounting of this collimator to the X-ray tube
housing, the following installation guidelines should be followed.

1. Two different lengths of screws are provided in the cloth bag 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.

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 flange 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..

November 2005 MC150 PINNACLE


(2-3)
Verify that the collimator mounting screws engage the housing by at least five (5)
threads when used with any required collimator spacer plate(s).
4. Carefully support the collimator in place and re-attach the clamping 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. Grasp and attempt to move the collimator and then the 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 CAN RESULT IN HEAVY
COMPONENTS FALLING DURING USE. INCIDENTS OF LOOSE SYSTEM COMPONENTS
SHOULD BE REPORTED IMMEDIATELY TO X-RAY SERVICE FOR REPAIR.

2.3.2 SKIN GUARD INSTALLATION (OPTIONAL)


NOTE: Refer to Figure 2.2

NOTE: Skin Guard Kits are optional and must be purchased separately from
collimator.

1. Remove the Front Cover Bezel, then the Left and Right Side Covers by removing the six
(6) 6-32 screws which keep them in place.

2. Mount the two (2) Skin Guard Rails to the Left and Right Side Covers using the four (4)
screws provided in the Skin Guard Kit.

3. Reattach the Left and Right Side Covers, then the Front Cover Bezel. After assembly, test
the field lamp timer for proper operation.

FIGURE 2.2 – SKIN GUARD INSTALLATION


DIMENSIONS

(2-4)

November 2005 MC150 PINNACLE


FIGURE 2.3 – COLLIMATOR MOUNTING DIMENSIONS

(2-5)

November 2005 MC150 PINNACLE


2.4 WIRING TO SYSTEM (NON-PROGENY) PROVIDED 24 VOLT AC POWER SUPPLY

(Refer to Cabling Outline Figure 2.4)


Follow this procedure if the MC150 PINNACLE will be powered by a power supply other
than a Progeny supplied 24 volt supply.
Connect the unterminated end of the supplied three wire cable and plug to a suitable 24
VAC source with a capacity of 8 Amps maximum. Make the connections as per the
following:
BLACK - HOT (fused at 8 AMPS min.)
WHITE - Neutral
GREEN - Ground (Earth)

Connect the plug end of the cable to the receptacle provided in the rear of the collimator
head.
NOTE: It is the responsibility of the installer to insure that the collimator has been
connected to a source which has been fused for no more than 8 Amps.

WARNING: VERIFY INPUT POWER WITH LAMP OFF, IS NO GREATER THAN 24


VAC RMS. VERIFY 28 VDC SUPPLY ON PCB IS NO GREATER THAN 30 VDC.

FIGURE 2.4
WIRING WHEN USING A 24 VOLT AC SOURCE
PROVIDED BY X-RAY SYSTEM (NON-PROGENY)

(2-6)

November 2005 MC150 PINNACLE


2.5 MOUNTING AND WIRING OF PROGENY POWER SUPPLY (70-20254)

2.5.1The power chassis is intended to be mounted on a wall or in an equipment cabinet.


There are holes in the bottom of the enclosure to allow mounting. Follow all local wiring
codes and locate the enclosure in an area that will permit:

• Cable Bend Radius


• Convection Cooling
• Access to Fuses F1 and F2

External connections to the system are made to the free ends of the two cables
permanently attached to the Power Chassis. They include:
• 120V or 220 V power connector (input voltage is selectable on power supply
chassis)
• Power Chassis to Collimator (Plug Connection).

Refer to the Power Chassis drawing (Figure 2.5) for mounting dimensions.
1.5.2 All connections are made external to the Power Chassis (refer to Figure 2.6)

2.5.3 120 VAC or 230 VAC INPUT

Connect the three wire cables supplied to the VAC source as follows:
Black - Hot
White - Neutral
Green - Ground

Remove the protective sheet metal cover.


Measure AC power source with a RMS type voltmeter and record reading.
Connect the power source to the transformer tap closest to the power source voltage read.
The taps are numbered as follows for:

120 VAC Transformer (Power Supply 70-20254)


Primary: 0V, 105, 115, 125 VRMS 47-63 Hz
Secondary: Full load 19, 27 VRMS @ 6-25 Amps

220 VAC Transformer (Power Supply 70-20288)


Primary: 0V, 210, 230, 250 VRMS 47-63 Hz
Secondary: Full load, 19, 27 VRMS @ 6-25 Amps

120 VOLT OPERATION


Line VAC L1 (Black) L2 (White
125 4 and 8 1 and 5
115 3 and 7 1 and 5
105 2 and 6 1 and 5

220 VOLT OPERATION


Line VAC L1 (Black) L2 (White) Connect
250 8 1 4 and 5
230 7 1 3 and 5
210 6 1 2 and 5
(2-7)

November 2005 MC150 PINNACLE


2.5.4 Route the Collimator cable and plug between the Power Chassis and Collimator Head
as desired. Connect plug B4 inserting it into receptacle and turning clockwise until it is
secure.

FIGURE 2.5
PROGENY POWER SUPPLY CHASSIS

HIGH ENERGY (NEC) 20 FT.


3 COND. CABLE
PROGENY SUPPLIED

COLLIMATOR
PROGENY
POWER SUPPLY
70-20254

CABLE CONFIGURATION FOR 70-63000 LINEAR MC150


WHEN USING PROGENY POWER SUPPLY 70-20254

FIGURE 2.6
WIRING TO PROGENY PROVIDED POWER SUPPLY

(2-8)
November 2005 MC150 PINNACLE
CALIBRATION

FOR ALL NEW SYSTEMS, THE CALIBRATION PROCEDURE NEED NOT BE


PERFORMED IF THE UNIT TESTS SATISFACTORILY FOR X-RAY FIELD TO
LIGHT FIELD ALIGNMENT. BEGIN CALIBRATION BY PRESSING THE CAL
SWITCH, SW S1, ON THE CONTROL PCB WHILE POWER IS TURNED ON.
THEN PROCEED WITH THE FOLLOWING STEPS:

IF CALIBRATION IS TO BE PERFORMED, BOTH INCH CAL AND METRIC CAL


WILL BE REQUIRED. FIRST, PLACE A SHUNT IN THE “INCH” POSITION OF JP2,
AND PLACE A SHUNT IN POSITION 1 (TOPMOST) OF HEADER JP1. THEN,
WHEN SWITCH S1 IS PRESSED THE FIELD SIZE CALIBRATION IN INCHES WILL
BE ENTERED. WHEN COMPLETED, MOVE THE SHUNT OF JP2 TO THE “CM”
POSITION. THEN PRESS SWITCH S1 TO PERFORM THE FIELD SIZE
CALIBRATION FOR CM SIZES.

ACTION TAKEN FRONT PANEL DISPLAY

1. Press Cal button on Logic PCB. Flash green Ready Light.


Light will continue to blink
Throughout the calibration procedure.

2. Close Shutters to minimum opening.


Press Cal button on Logic PCB. 0.0 x 0.0 OR 0.0 x 0.0
40 100

3. Open Shutters to 17 inch size at 40 inch SID.


Or 43 cm size at 100 cm SID.
Press Cal button on Logic PCB. 17 x 17 OR 43 x 43
40 100

4. Open Shutters to 15 inch (38 cm) size at


40 inch (100 cm) SID.
Press Cal button on Logic PCB. 15 x 15 OR 38 x 38
40 100

5. Open Shutters to 13 inch size at 40 inch SID.


Or 33 cm size at 100 cm SID.
Press Cal button on Logic PCB. 13 x 13 OR 33 x 33
40 100

6. Open Shutters to 11 inch size at 40 inch SID.


Or 28 cm size at 100 cm SID.
Press Cal button on Logic PCB. 11 x 11 OR 28 x 28
40 100

(2-9)

November 2005 MC150 PINNACLE


7. Open Shutters to 9 inch size at 40 inch SID.
Or 23 cm size at 100 cm SID.
Press Cal button on Logic PCB. 9x9 OR 23 x 23
40 100

8. Open Shutters to 7 inch size at 40 inch SID.


Or 23 cm size at 100 cm SID.
Press Cal button on Logic PCB. 7x7 OR 18 x 18
40 100

9. Open Shutters to 5 inch size at 40 inch SID.


Or 13 cm size at 100 cm SID.
Press Cal button on Logic PCB. 5x5 OR 13 x 13
40 100

Now use the template provided with the collimator providing the sizes required at 72 SID. The
template is designed to be placed at 40 inch SID and the sizes are the proportional sizes
needed to achieve the displayed sizes at 72 inch SID.

10. Open Shutters to 17 inch size at 72 inch SID.


Or 43 cm size at 180 cm SID.
Press Cal button on Logic PCB. 17 x 17 OR 43 x 43
72 180

11. Open Shutters to 15 inch size at 72 inch SID.


Or 38 cm size at 180 cm SID.
Press Cal button on Logic PCB. 15 x 15 OR 38 x 38
72 180

12. Open Shutters to 13 inch size at 72 inch SID.


Or 33 cm size at 180 cm SID.
Press Cal button on Logic PCB. 13 x 13 OR 33 x 33
72 180

13. Open Shutters to 11 inch size at 72 inch SID.


Or 28 cm size at 180 cm SID.
Press Cal button on Logic PCB. 11 x 11 OR 28 x 28
72 180

14. Open Shutters to 9 inch size at 72 inch SID.


Or 23 cm size at 180 cm SID.
Press Cal button on Logic PCB. 9x9 OR 23 x 23
72 180

(2-10)

November 2005 MC150 PINNACLE


Open Shutters to 7 inch size at 72 inch SID.
Or 18 cm size at 180 cm SID.
Press Cal button on Logic PCB. 7x7 OR 18 X 18
72 180

15. Open Shutters to 5 inch size at 72 inch SID.


Or 13 cm size at 180 cm SID.
Press Cal button on Logic PCB. 5x5 OR 13 x 13
72 180

2.6 PRESET FIELD SIZE CALIBRATION

To enable calibration, a shunt must be placed in header JP1 position 2 (second from top
position). In addition, there must be no shunt in the topmost position of header JP1. The
preset field size calibration begins by pressing the S1 momentary switch on the Pinnacle control
PCB.

When pressed, the cross field size will flash indicating it can be changed for memory. The
operator uses the UP and DOWN arrow keys to set the size desired. When acceptable, the
ROTATE key is pressed to save the cross field size. Then, the long field size will flash and
allow modification in the same way. When the long field size is accepted, the SID display will
flash. At this time, the operator may set the SID of the size by using the SID button as well as
the size in either inches or metric by using the UP and DOWN arrow keys. When the SID scale
and inch/metric is acceptable, the preset field size is stored by pressing the ROTATE key.

This procedure is repeated for each of the ten stored field size settings. If it is desired to not
use any of the ten saved settings, each setting can be set to 0 and stored. It will then be
invisible to use.

As shipped from Progeny, the preset field sizes are as follows:

Inches Metric (cm)

14 x 17 35 x 43
14 x 14 35 x 35
11 x 14 30 x 35
10 x 12 24 x 30
8 x 10 18 x 24

(2-11)

November 2005 MC150 PINNACLE


2.7 VOLTAGE ADJUSTMENT FOR FIELD SIZE FEEDBACK POTENTIOMETERS

The field size feedback potentiometers are set at the factory for 200 ohms when the
shutters are fully closed. However, due to mechanical losses, the potentiometer reading
is not always exact. In order to achieve a factory standard feedback reading for every
collimator, there is an adjustment to be made to the feedback pot voltage. This
adjustment is made at the factory and should not be made in the field without first
consulting the factory technical service department. The adjustment is achieved as
follows:

First, place a voltmeter on TP1, “VREF”. This voltage should be 5.00 volts. Adjust
potentiometer to set this voltage.

VREF = 5.00 volts

Next, place a voltmeter on TP2 “VXFC. Fully close the cross shutters and record the
voltage. The desired voltage is 1.10, however variance of + or – 0.25 is common.

VXFC = ________

To initiate the adjustment procedure, place a shunt in position 7 (bottom most) of header
JP1 on the Control PCB. Then press SW1 momentarily. The procedure begins by
flashing the field size display for the CROSS shutters. This indicates that the CROSS
feedback potentiometer is to be adjusted first. The SID display now shows the output of
the trimpot labeled CROSS ADJUSTMENT. The number displayed is a number
between 0 and 255, with 0 representing 0 volts and 255 representing VREF, which is
5.00 volts. Adjusting the trimpot will provide a signal to the collimator that an adjustment
is required to either increase or decrease the VXFC signal. The 0 adjustment level is
128. First adjust the trimpot so the display reads 128. The number over 128 will add to
the VXFC signal and the number below 128 will subtact from the VXFC signal.

Now determine how much adjustment is required. First subtract the desired voltage of
1.10 from the recorded VXFC.

Delta Voltage = 1.10 – VXFC = _______

If delta voltage is positive, we will increase the cross adjustment trimpot over 128. If it is
negative, the 128 number will be reduced. Each one increment in the number
represents an adjustment of 0.02 volts. Determine the number to change by the
following equation:

Delta Voltage / 0.0196 = Result = _________ (round to the nearest integer)

Now adjust the trimpot so the reading is 128 + Result. If result is negative, 128 will be
reduced. When the desired number is displayed, the VXFC adjustment is complete.
Pressing the ROTATE key on the front panel will proceed with the VXFL adjustment for
the long shutter field.

(2-12)
November 2005 MC150 PINNACLE
Next, place a voltmeter on TP3 “VXFL. Fully close the cross shutters and record the voltage.
The desired voltage is 1.10, however variance of + or – 0.25 is common.

VXFL = ________

The procedure begins by flashing the field size display for the LONG shutters. This indicates
that the LONG feedback potentiometer is to be adjusted. The SID display now shows the
output of the trimpot labeled LONG ADJUSTMENT. The number displayed is a number
between 0 and 255, with 0 representing 0 volts and 255 representing VREF, which is 5.00 volts.
Adjusting the trimpot will provide a signal to the collimator that an adjustment is required to
either increase or decrease the VXFL signal. The 0 adjustment level is 128. First adjust the
trimpot so the display reads 128. The number over 128 will add to the VXFL signal and the
number below 128 will subtract from the VXFL signal.

Now determine how much adjustment is required. First subtract the desired voltage of 1.10
from the recorded VXFL.

Delta Voltage = 1.10 – VXFL = _________

If delta voltage is positive, we will increase the long adjustment trimpot over 128. If it is
negative, the 128 number will be reduced. Each one increment in the number represents an
adjustment of 0.02 volts. Determine the number to change by the following equation:

Delta Voltage / 0.0196 = Result = _________ (round to the nearest integer)

Now adjust the long trimpot so the reading is 128 + Result. If result is negative, 128 will be
reduced. When the desired number is displayed, the VXFL adjustment is complete. Pressing
the ROTATE key on the front panel will return the collimator to normal operation.

(2-13)

November 2005 MC150 PINNACLE


NO TEXT

(2-14)
November 2005 MC150 PINNACLE
SECTION 3.0
OPERATIONAL
CHECK-OUT
PROCEDURE

(3-1)

November 2005 MC150 PINNACLE


3.0 OPERATIONAL CHECK-OUT PROCEDURE

3.1 Operational Check - After the Collimator, Power Chassis and cabling have been installed,
apply 24 VAC power and observe the face plate of the collimator.

3.1.1 Push the LAMP button and check that the light field lamp remains on for
approximately 25 seconds.

3.1.2 While the field lamp is on, be sure the light field can be collimated to required
size with the control knobs.

3.1.3 While the field lamp is on, select different sizes cassettes stored in memory, be
sure the light field can be collimated to selected sizes.

3.2 LIGHT FIELD/X-RAY FIELD CONGRUENCE TEST

The following operational check is performed with the collimator located in a single fixed
position above a test pattern located on the table top.
Any required adjustments are made while observing the light-field edges, therefore it is
necessary to confirm that the light-field is representing the X-ray field. By establishing a
defined light-field and exposing a film to a density of 1.0, the X-ray field (image) can be
compared to the light-field.
The X-ray field should be determined by exposing film to a density of 1.0 on the developed
image, and observing the point at which the density is just visibly increased above the fog
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 point at which the light field is just visibly
increased over the background illumination, and comparing this to the X-ray field (and to the
tolerance marks on the pattern), congruence comparisons may be made.
NOTE: The Performance Standards 1020.30 (b)(22) and (45) define the edges of the light
field where the illumination is one-fourth of the maximum and the edges of the X-ray field
where the exposure rate is one-fourth of the maximum.
EQUIPMENT REQUIRED:

A. LINEAR collimator test pattern (contained in this manual)


B. Measuring tape (ruler)
C. 14” x 17” (35 cm x 43 cm) X-ray film cassette
D. Densitometer (or a 1.0 density neutral density filter for a density comparison).

3.2.1Remove the LINEAR collimator table-top TEST PATTERN #1 from this manual and
position it on the table-top with the edges parallel to the table-top edges. Flatten the
creases and tap it into position at the corners in a manner that will not damage it upon
removal.

(3-2)

November 2005 MC150 PINNACLE


3.2.2Angulate the collimator to 0° horizontal. Position the collimator at a focal spot to
TEST PATTERN distance of 40” or 100 cm + 0.2 cm by measuring from the center of
the exit window to the center of the light-field; this distance should be 30.38” or 75.6
cm.

LIGHT FIELD/X-RAY CONGRUENCE TEST

3.2.3 Place the X-ray source to table distance at 40 inches or 100 cm SID.

3.2.4 Locate a cassette on the table-top and accurately center the cassette to the light-
field.

3.2.5 Manually reduce the size of the X-ray field to the next smaller film size.

3.2.6 Identify the light-field edges and carefully mark the edges by placing the metal
markers as illustrated in Figure 3.1.

3.2.7 Expose the film to a density of 1.0 and develop.

3.2.8 Carefully identify the X-ray field edges and measure the difference between the X-
ray field edges and light-field edges.

3.2.9 The sum of the long axis difference (X1 + X2) shall not exceed 2% of the SID, and
the sum of the cross axis difference shall not exceed 2% of the SID.

3.2.10 If errors exceed those shown in Figure 3.1 below, refer to Section 4.0.

(3-3)

November 2005 MC150 PINNACLE


LIGHT FIELD/X-RAY FIELD CONGRUENCE TEST

X1
METAL MARKER

LIGHT FIELD X-RAY FIELD

Y1 Y2

X2

X1 + X2 MUST BE LESS THAN 2% OF THE SID


Y1 + Y2 MUST BE LESS THAN 2% OF THE SID

FIGURE 3.1

(3-4)

November 2005 MC150 PINNACLE


SECTION 4.0
ADJUSTMENT and
ALIGNMENT PROCEDURES

(4-1)

November 2005 MC150 PINNACLE


CROSS-HAIR WINDOW ADJUSTMENT

FIGURE 4.1

(4-2)

November 2005 MC150 PINNACLE


4.0 ADJUSTMENT AND ALIGNMENT PROCEDURES

4.1 Field Projection Lamp and Mirror Adjustment

This procedure must be performed when the field projection lamp is altered from it’s original
position or replaced. This test must also be performed if the original mirror angle has been
altered and if any edge of the developed X-ray image is outside of the 30.5 cm x 30.5 cm @
100 cm tolerance marks as defined in Step 3.2.

4.1.1 Steps 3.1 through 3.2 should be carefully reviewed or repeated prior to a lamp or
mirror adjustment attempt. This is particularly important if only a single testing
indicates a failure to meet the requirements defined in Step 3.2.

4.1.2 The collimator position, and the developed X-ray film must remain undisturbed from
the position defined in Steps 3.1 through 3.2.

4.1.3 Remove the rear cover and the lamp housing heat shield.

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 THE LIGHT OUTPUT IS SUFFICIENT TO TEMPORARILY
IMPAIR YOUR VISION IF ALLOWED TO ENTER THE EYES DIRECTLY. MAINTAIN A
POSITION IN WHICH YOU CAN SEE NEITHER THE FILAMENT WHEN IT IS OFF, NOR
ALLOW LIGHT TO DIRECTLY ENTER YOUR FIELD OF VISION WHEN IT IS ON.
4.1.4 If the developed X-ray image (steps 1 through 9 in section 3.2) is off-center in the
longitudinal direction, loosen the two screws securing the lamp housing.

4.1.5 Use a pair of long nose pliers to move the lamp housing slightly until the light field
has shifted to a position that is centered to the developed X-ray image in the
longitudinal direction.

4.1.6 If the developed X-ray image (steps 1 through 9 in section 3.2) is in error in the
cross-table direction, adjust the angle of the mirror (using the adjustment screw)
until the light field has shifted to a position that is centered to the developed X-ray
image.

4.1.7 If the X-ray image is smaller than the light field, loosen the screws securing the
lamp socket and use a pair of long nose pliers to move the socket further away
from the center of the collimator until light field/x-ray field congruency has been
achieved

4.1.8 If the X-ray image is larger than the light field, loosen the screws securing the lamp
socket and use a pair of long nose pliers to move the socket closer to the center
of the collimator until light field/x-ray field congruency has been achieved.

4.1.9 Repeat steps 1 through 9 in section 3.2 to confirm the results of the above
adjustment.

4.1.10 Tighten the lamp bracket screws and replace the rear cover.

(4-3)

November 2005 MC150 PINNACLE


4.2 CROSS HAIR WINDOW ADJUSTMENT

This procedure is to be performed if the cross hair shadows are not centered to the light
field (Reference Figure 4.1).
4.2.1 Remove the spacer and the entire collimator enclosure.
4.2.2 Loosen the screws securing the plastic window.
4.2.3 Move the plastic window to align and center the cross hair pattern to the light field
(center lines on the test pattern).
4.2.4 Tighten the screws and reassemble the collimator covers.

4.3 BUCKY CENTERING LIGHT-LINE ADJUSTMENT

If the collimator is equipped with a Bucky Light-Line Prism:


4.3.1 This procedure is to be performed if the centering light-line is not centered to the
correctly adjusted light-field.
4.3.2 Remove the rear cover.

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


CAUSE SEVERE BURNS. DO NOT TOUCH ANY OBJECT IN THE LAMP AREA
WITH BARE SKIN.
WARNING: THE INTENSITY OF THE LIGHT OUTPUT IS SUFFICIENT TO
TEMPORARILY IMPAIR YOUR VISION IF ALLOWED TO ENTER THE EYES
DIRECTLY. MAINTAIN A POSITION IN WHICH YOU CAN SEE NEITHER THE
FILAMENT WHEN IT IS OFF, NOR ALLOW LIGHT TO DIRECTLY ENTER YOUR
FIELD OF VISION WHEN IT IS ON.
4.3.3 If the centering light-line is off-center to the correctly centered light-field or
exhibits a rainbow of colors along one edge, loosen the two screws securing the
prism/slit bracket See Figure 4.2.

4.3.4 Use a pair of long-nose pliers to move the bracket as required to center the light-
line to the correctly adjusted light-field.

NOTE: IN ORDER TO AVOID THE RAINBOW OF COLORS ALONG THE EDGES,


MAINTAIN THE PRISM IN A POSITION THAT IS CENTERED TO THE BRIGHT LIGHT-
LINE THAT IS OBSERVED ON THE BRACKET AT THE BASE OF THE PRISM WHILE
ADJUSTING THE BRACKET.

4.3.5 Tighten the screws and replace the collimator covers.

(4-4)

November 2005 MC150 PINNACLE


If the collimator is equipped with a Bucky Light-Line Laser:

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.
MAINTAIN A POSITION IN WHICH YOU CAN SEE NEITHER THE
FILAMENT WHEN IT IS OFF, NOR ALLOW LIGHT TO DIRECTLY ENTER
YOUR FIELD OF VISION WHEN IT IS ON.

CAUTION! This unit utilizes a low power (2.5 x 10ˉ³ W 650 nm) Class II laser to
produce an alignment beam. DO NOT STARE DIRECTLY INTO BEAM OR
VIEW WITH OPTICAL INSTRUMENTS.

Laser Adjustment

1.) Verify alignment of the field light to the X-ray beam.

2.) Remove the covers from the collimator.

3.) Open the long shutters to the maximum setting.

4.) Close the long shutter to project a .25 to .50 wide beam onto the work surface.

5.) 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.

6.) Note the laser line to field light position and alignment at the extremes of the
projection board movement.

7.) 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 and rotate the laser
module until the laser line is parallel and in alignment with the field light projection.

8.) Lateral (side to side) adjustment: Loosen the bracket laser mounting screws and
adjust the laser side to side in the slots provided. Tighten the mounting screws.

9.) Longitudinal angular adjustment: Indicated by the laser line projection moving from
one side to the other of the field light projection. Loosen the module mount screws.
Move laser module to appropriate direction.

10.)Reinstall the covers on the collimator.

(4.5)

November 2005 MC150 PINNACLE


Laser Bucky line Projections

Figure 4.2
Reference View of Laser Parts

(4.6)

November 2005 MC150 PINNACLE


Cover Removed

Mirror Retractor

Lamp/Lightfield Adjustment Longitudinal Alignment

CROSS ALIGNMENT LONGITUDINAL ALIGNMENT

1. Adjust two #6-32 screws for 1. Slightly loosen the two #6-32 screws
light-field alignment. 2. Position lamp bracket laterally for
2. (Option) Add Loctite to set in light-field alignment, left to right.
position. 3. Tighten the two #6-32 screws.

FIGURE 4.2 - LIGHT-FIELD ADJUSTMENT


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. MAINTAIN A
POSITION IN WHICH YOU CAN SEE NEITHER THE FILAMENT WHEN IT IS OFF, NOR
ALLOW LIGHT TO DIRECTLY ENTER YOUR FIELD OF VISION WHEN IT IS ON.
CAUTION: BOTH CROSS AND LONG SHUTTERS MUST BE FULLY OPEN FOR ANY
MIRROR RETRACTION - FORCING THE MIRROR WILL MISCALIBRATE THE LIGHT-
FIELD!

(4-7)

November 2005 MC150 PINNACLE


SECTION 5.0

COMPLIANCE
VERIFICATION

(5-1)

November 2005 MC150 PINNACLE


FIGURE 5.1 BRN/FDA COMPLIANCE TEST STAND

FIGURE 5.2 COMPLIANCE STAND DETAIL

(5-2)

November 2005 MC150 PINNACLE


5.0 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 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 Eureka Linear Collimator. Any reference to 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 OF TESTS TO BE PERFORMED
Test Procedure or Requirement Applicable Paragraph

1. Determination of Half Value Layer XR8/2.09


2. Visual Definition of X-Ray Light Field XR8/2.14
3. Intensity of Light Field Illumination XR8/2.15
4. X-Ray Field/Receptor Center Alignment XR8/2.17
5. Indication of Field Size XR8/2.18
6. X-Ray Field Limitation and Alignment XR8/2.20

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

(5-3)

November 2005 MC150 PINNACLE


XR 8-2.09 BEAM QUALITY (HALF-VALUE LAYER [HVL])
REQUIREMENT- The minimum beam quality requirements listed in Table 5-1 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 5-2.
B. Equipment
None is required.

Table 5-1 MINIMUM BEAM QUALITY REQUIREMENTS


Kvp Range Measured kVp HVL (mmAl*)
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 5-2 ALUMINUM EQUIVALENT OF PRIMARY BEAM TOTAL FILTRATION

Operating Voltage (kVp) Total Filtration (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).

(5-4)
D. VERIFICATION OF COMPLIANCE
November 2005 MC150 PINNACLE
The aluminum equivalence of the total filtration must be equal to or greater than the
amount specified in Table 5-1.
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 5-1. The HVL in millimeters of aluminum of the system being
tested must be greater than or equal to the values shown in Table 5-1.

B. EQUIPMENT

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

C. PROCEDURE

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


preselected technique factor of 80 kVp and appropriate mA and time. The reading of
the radiation output is recorded.
2. Position a total of 2.5 millimeters of aluminum at the port of the beam-limiting device and repeat
the exposure using the same technique factors. Record the radiation output.

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

D. VERIFICATION OF COMPLIANCE

Verify that the radiation output in step 2 is greater than or equal to 50 percent of the
radiation output in step 1.
.03 METHOD III - BRH/FDA COMPLIANCE TEST

A. GENERAL

The HVL determinations obtained from the following procedures are to be


compared with those illustrated in Table 5-1. The HVL in millimeters of aluminum of
the system being tested must be greater than or equal to the values shown in Table 5-
1.

B. EQUIPMENT

1. BRH/FDA compliance test standard 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.

(5-5)

November 2005 MC150 PINNACLE


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 (See Figure 5-1). 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 5-3 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 5-3 HIGHEST DESIGN OPERATING RANGE

Total Added Filtration, mm Al


Below 50 - 70 Above
50 kVp kVp 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 (Examples A and B, Fig. 5-6)
and the half-value is read directly from the graph.

D. VERIFICATION OF COMPLIANCE

Verify that the half-value layer of the useful beam for a given X-ray tube potential is not
less than the values shown in table 5-1.
NEMA Standard 5-15-1979

(5-6)

November 2005 MC150 PINNACLE


FIGURE 5.3 LIGHT FIELD vs. X-RAY FIELD ERROR MEASUREMENTS

(5-7)

November 2005 MC150 PINNACLE


TABLE 5-4 HALF VALUE LAYERS AS A FUNCTION OF FILTRATION AND TUBE
POTENTIAL FOR 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 2.70 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 5-6
HALF-VALUE LAYER DETERMINATION GRAPHS

(5-8)

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PINNACLE
XR 8-2.14 VISUAL DEFINITION (RADIOGRAPHIC) OF 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 1 - 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 (Figure 5-2). Place a cassette loaded with
direct print paper or film into the slide assembly.

3. Adjust the collimator so 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 side assembly grid may be desirable to
assure that the X-ray field will be fully contained on the direct print paper for
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.

(5-9)

November 2005 MC150


PINNACLE
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 (see Paragraph D and Figure 5.3).

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 (1.85 in) and record.
Calculate 2 percent of this SID and record. Both the length and 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)
X = 34.875
S - 2.5

The misalignments are calculated as follows:


Length misalignment = L1 + L2 ≤ 2% SID
Width misalignment = W 1 + 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 Standards 5-15-79

.02 METHOD II - METAL MARKER METHOD

A. GENERAL

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

(5-10)

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PINNACLE
FIGURE 5-4 CALCULATION EXAMPLE

FIGURE 5-5 METAL MARKER METHOD

(5-11)

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PINNACLE
B. EQUIPMENT
1. Plastic cassette with direct printer paper or film.

2. Radio-opaque markers*
• Each marker is approximately .080 cm galvanized sheet metal having the
dimensions of 4 by 4 cm.

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 table top to correspond
with each side of the light-field (Figure 5-5).

4. Select the appropriate technique factors and make an exposure.

5. Develop film or direct-print paper.

D. VERIFICATION OF COMPLIANCE
For determination of misalignment, compare the edges of the X-ray field to the edges
of the light field as defined by the outer edges of the metal strips. On each side of the
rectangular fields, measure the separation between the X-ray field and the outside
edge of the image of the respective metal strip. Sum these measured separations for
opposite sides of the X-ray field to yield a total misalignment in the length and width
dimensions. Record the length misalignment and width misalignment, both without
regard to sign (see Par. E and Figure 5-3 ).

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)

X = 34.875
S - 2.5

The misalignments are calculated as follows:


Length misalignment = L1 + L2 ≤ 2% SID
Width misalignment = W 1 + 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 Standards 5-15-79
(5-12)

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PINNACLE
.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 SID must be determined prior to performing this test.

B. EQUIPMENT

1. Manufacturer’s recommended test stand.

2. Cassettes and film.

3. Graduated template

C. PROCEDURE

1. Align the tube unit and image receptor and set the SID with the normal operating
aids (detents, scales, lights, etc.)

2. Load cassette and insert into image receptor.

3. Close shutters to a size smaller than that of the cassette placed into the image
receptor.

4. Position the test stand in accordance with the manufacturer’s instructions.

5. Energize the field light and record or define the position of the four light field
edges as shown on the graduated template or position four metal markers so
that the outer edge of each metal marker corresponds to an edge on each side
of the light-field or both.

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

D. VERIFICATION OF COMPLIANCE

1. Calculate 2 percent of the actual SID and record.

2. Compare the edges of the X-ray field to the edges of the light field as defined by
the outer edges of the metal markers or by the graduated scale.

3. Measure the distance between the edges of the two fields for each side of the
rectangular fields (see Figure 5-3).

(5-13)

November 2005 MC150


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

Length misalignment = L1 + L2 ≤ 2% SID


Width misalignment = W 1 + W2 ≤ 2% SID

Both the length and width misalignment must be less than 2 percent SID as
calculated in Step 1.
NEMA Standards 5-15-79 1/3

XR 8-2.15 INTENSITY OF LIGHT FIELD ILLUMINATION

.01 REQUIREMENT

A. GENERAL

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

1. The graduated template is utilized to minimize the amount of error introduced into
the measurement of the X-ray field size.

2. 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. 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.
(5-14)

November 2005 MC150


PINNACLE
6. Repeat the procedure for the remaining three quadrants.

7. Determine the average illuminance of the four light field quadrants.

8. Record the model number, serial number, and the date of calibration of test
instrument.

D. VERIFICATION OF COMPLIANCE

Verify that the average illumination is not less than 160 lux (15 footcandles).
NEMA Standards 5-15-79

.02 METHOD II - INDIRECT TEST

A. GENERAL

1. This indirect test is feasible after the correlation between light output and voltage
is made; the manufacturer then specifies a voltage to be measured or adjusted,
or both.

2. Make certain that all surfaces in the light path are clean and unobstructed.

B. EQUIPMENT

Digital voltmeter

C. PROCEDURE

1. Remove trim covers to gain access to the lamp socket.

2. Verify that the specified lamp is in the socket.

3. With the light-field energized, measure the voltage across the lamp socket
terminals.

4. Record the voltage measured.

5. Record the model number, serial number and calibration date of the digital
voltmeter.

D. VERIFICATION OF COMPLIANCE

The voltage recorded shall be within the tolerances specified by the manufacturer.
NEMA Standard 5-15-1979

(5-15)

November 2005 MC150


PINNACLE
NOTE: THE AC VOLTAGE AT THE LAMP SOCKET MUST NOT BE LESS THAN 19.5
VAC RMS
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 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.
6. Actual versus indicated SID must be determined prior to performing this test.

B. EQUIPMENT

Radiographic cassette loaded with film (20 by 25 cm).

C. PROCEDURE

1. Load cassette with film and place into the bucky tray.

2. Assure 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 15 by 20 cm.

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 of the centers of the X-ray field
and the image receptor.

D. VERIFICATION OF COMPLIANCE

Verify that this distance is less than or equal to 2 percent of the SID.
NEMA Standards 5-15-79
(5-16)

November 2005 MC150


PINNACLE
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 SID (see 21 CFR 1020.31 (e) (1).
A. GENERAL

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

EQUIPMENT

A 24 by 30 centimeter or a 20 by 25 cm cassette with film.

C. PROCEDURE

1. Set the SID to the value determined in the actual versus indicated SID test.

2. Center the film cassette in the cassette tray and insert into position.

3. Adjust the field size to 15 by 15 centimeters or 8 by 8 inches by means of the


numerical indicators on the beam-limiting device.

4. Make an exposure and develop film.

5. Measure and record the length and width dimensions of the image.

D. VERIFICATION OF COMPLIANCE

The deviation of any of the recorded dimensions must not exceed 2 percent of the SID
in Step 1.
NEMA Standards 5-15-79

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 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 1 - BRH/FDA TEST STAND METHOD

A. EQUIPMENT

1. BRH/FDA compliance test stand with accessories

2. Slide assembly

(5-17)

November 2005 MC150


PINNACLE
3. Plastic cassette containing a sheet of direct print paper or X-ray film

4. Ruler

5. Cassette (preferably 20 to 25 cm or smaller).

B. PROCEDURE

1. Using the means provided, align the source assembly so that the beam axis is
perpendicular to the image receptor.

2. Place the test stand on the table.

3. Position the spacer so that it does not 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.
bucky light.

5. Bring the source assembly down into 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 5-2).

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 and length and with
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 19.5 cm.


Multiply each of the measured dimensions by the correction factor.

X-ray field length at


undertable image receptor = SID x (X-ray field length at slot 5)
A
X-ray field width at
undertable image receptor = SID x (X-ray field width at slot 5)
A

(5-18)
Determine the difference without regard to sign between the corrected length and width
dimensions and the corresponding cassette film size dimensions (20 by 25, 13 by 18,

November 2005 MC150


PINNACLE
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.
NEMA Standards 5-15-79

.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 18 by 24 cm 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.

B. VERIFICATION OF COMPLIANCE

Verify that the X-Ray field size in the plane of the image receptor does not differ from
hat 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 not greater than 4 percent
of the SID.
NEMA Standards 5-15-79

(5-19)
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 # ___________________

November 2005 MC150


PINNACLE
DATE OF INSTALLATION _________________________ ASSEMBLER _______________
_______________________________________________ _______________

Applicable Installation
Requirement Paragraph Date Date Date Date Date

1. Determination of XR8/2.09
Half-Value Layer

2. Visual definition of XR8/2.14


X-Ray light field

3. Intensity of light-field XR8/2.15

4. X-Ray field/receptor XR8/2.17


center alignment

5. Indication of field size XR8/2.18

6. X-Ray field Limitation XR8/2.20


& Alignment

7. Cassette Tray/
Inspection Cleaning

8. Electrical Cable
Inspection
INITIALS:

NOTES:

(5-20)

November 2005 MC150


PINNACLE
SECTION 6.0

THEORY OF OPERATION

(6-1)

November 2005 MC150


PINNACLE
User Keypad Input Mode

When this mode is entered, the software has sensed that one of the keys, SID, ROT,
UP, or DOWN, has been pressed. The operation is dependant on which of the keys has been
pressed.

If the SID key has been pressed, the software will display the SID which is not show,
i.e., if 40 is displayed before the key press, 72 will be displayed, and vice versa. Following this,
the software will compute the size of the field on the new SID scale. This size will be displayed
and the mode will be exited as described below.

If the ROT key ahs been pressed, the field display will alternate values from cross to
long, eg., 14 x 17 will now display 17 x 14. The mode will then be exited as described below.

If either the UP of DOWN key has been pressed, the pointer to the array of stored
preset field sizes is incremented or decremented appropriately. The new preset preset field
size is displayed and the mode is exited as described below.

In all cases after the display is updated, the User Keypad Input mode will monitor the
keys for approximately one second. If a key is pressed during this time, the action(s) discribed
above will be repeated. If no key is pressed, the mode will conclude and transfer to the Change
Field Size Mode.

(6-2)

November 2005 MC150


PINNACLE
SECTION 7.0

REPLACEMENT
PARTS LIST

(7-1)
MC150 PINNACLE
REPLACEMENT PARTS LIST
EUREKA P/N DESCRIPTION

November 2005 MC150


PINNACLE
COLLIMATOR
70-11201 Swivel Mounting Ring - Tube Side
70-10008 Swivel Mounting Ring - Collimator Side
70-10036 Swivel Ring Collar
26-00752 Collar Screw
70-11089 Window - Cross Hair
70-20264 Cross Hair Kit with Brackets
70-04752 Knob - Front Panel
70-08181 Push Button Switch Assembly
70-11126 Lens for Push Button Switch
70-04263 Lamp for Push Button Switch
70-11026 Cover - Front Bezel
70-11127 Cover - Top
70-11028 Cover - Rear
70-11129 Cover, Left Side
70-11130 Cover, Right Side
70-04571 Lamp - Light Field - DZE 24 Vac, 150W (mfg. before December 2003)
70-04300 Lamp – Light Field – FCS 24 Vac, 150W (mfg. after November 2003)
70-04572 Socket – Lamp (mfg. before December 2003)
70-04299 Socket – Lamp (mfg. after November 2003)
70-01901 Current Limit Resistor
70-03051 Triac, 15 Amp, Lamp Timer
70-10096 Prism, Centering Light-Line
70-20024 Mirror/Bracket Assembly
70-20164 Low Filtration Mirror/Bracket Assembly
70-20265 Cone Track Kit (Optional)
70-11285 Cross Shutter Field Size Dial
70-11286 Long Shutter Field Size Dial
70-11075 Tape Measure
70-10282 Skin Guard (76.2 mm) – Optional
70-20332 Skin Guard (152.4 mm) – Optional
70-08177 MC150 Interconnect Cable
70-10810 Thumbscrew - Rear Cover
70-20319 Axle Clamp Kit
70-11200 Dual Cone Track (for use with dosimeters)

POWER SUPPLY UNIT 70-20254


70-06016 Transformer - Power 27/19 VAC
70-04603 Fuse - 2 Amp SloBlo - Power
70-04607 Fuse – 8 Amp SloBlo – Lamp

POWER SUPPLY UNIT 70-20288 (220V INPUT)


70-06018 Transformer – Power 27/19 VAC
70-04602 Fuse – 1 Amp SloBlo – Power
70-04607 Fuse – 8 Amp SloBlo - Lamp
(7-2)

November 2005 MC150


PINNACLE
SECTION 8.0

APPENDIX

(8-1)

DEFINITIONS

SID Source to Image receptor Distance


VSID Voltage representing SID

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VCSID Voltage representing Continuous SID
SID TRUE Signal representing the Operating SID Range
XF X-ray Field
VXFC Voltage at the Collimator Feedback Potentiometer Wiper representing
The X-ray Field in the Long Dimension
VXFL Voltage at the Collimator Feedback Potentiometer Wiper representing
The X-ray Field in the Long Dimension
IR Image Receptor (Cassette Tray)
VIRC Voltage from the Cassette Sensing Element representing the Image
Receptor size in the Cross Dimension
VIRL Voltage from the Cassette Sensing Element representing the Image
Receptor size in the Long Dimension
IR TRUE Voltage representing the Presence of a Cassette
VCPC Voltage applied to the Collimator Potentiometers in the Cross Position
VCPL Voltage applied to the Collimator Potentiometers in the Long Position

(8-2)
TABLE 1.
The following list is intended to help the installer determine mounting information only, and does
not imply compatibility. See Section 1-0 for compatability information.

FOCAL SPOT DISTANCE TO

November 2005 MC150


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TO COLLIMATOR
MANUFACTURER TUBE HOUSING PORT MOUNTING MOUNTING FLANGE
Eureka Emerald Series 2 - 1/16” 3/8” (.95 cm)
Diamond Series 2 - 1/16” 3/8” (.95 cm)
Sapphire Series 2 - 3/16” ¼” (.635 cm)
Varian/Eimac B100 2 - 17/64” 11/64” (.434 cm)
B150 2 - 11/64” 17/64” (.637 cm)
B160 2 - ¼” 3/16” (.477 cm)
B180 2 - ¼” 3/16” (.477 cm)
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” ¼” (.250)
PX - 1400 2 - 5/16” 1/8” (.125)
Machlett DX40 Series 2 - 1/16” 3/8” (.375)
DX50 Series 2 - 3/16” ¼” (.250)
DX60 Series 2 - 5/16” 1/8” (.125)
DX70 Series 2 - 5/16” 1/8” (.125)

(8-3)

November 2005 MC150


PINNACLE
Eureka Progeny Inc.• 1407 Barclay Blvd. •Buffalo Grove, IL 60089

BILL OF MATERIAL 70-08380 MC150 Pinnacle Microcontroller


Rev. G ECN P0890
ITEM QTY DWG PART ITEM DESCRIPTION Vendor Ref.
NO. SIZE NO. CLS Part No. Designator
1 1 B 70-06324 Fabrication, PCB Linear II Microcontroller
2 2 A 70-04806 Shunt JP1,JP2
3 1 A 70-02511 Capacitor, Tantalum 10 uF 35V C1
4 2 A 70-02010 Capacitor, Ceramic .1 uF 50V C2, C9
5 2 A 70-02030 Cap., Ceramic CK05, .001MFD, 200WVDC C4, C6
6 2 A 70-02031 Capacitor, Mica, 300 WVDC, 22pF C3, C5
7 2 B 70-02524 Capacitor, Aluminum 63 WVDC, 100 uF C7, C11
8 2 A 70-02501 Capacitor, Electrolytic, 1uF, 50v C8,C10
10 7 A 70-02012 Capacitor, Ceramic .01 uF 100V C12,C16,C18,C19,
C23,C25,C34
11 14 A 70-02021 Capacitor, Ceramic .22 uF 50V C3,C13,C15,C17,
C20,C22,C24,C
26,
C27,C28,C29,C
30, C31, C32,
C33
12 2 A 70-02101 Capacitor, 50 WVDC, 10uF C14, C21
13 3 A 70-03001 Diode, 1N914 D1, D3, D4
15 1 A 70-03358 LM336Z-5.0 Reference Diode D2
16 4 A 70-03012 IN4002 Diode IN4002 D6, D7, D8, D9
18 6 A 70-03043 Opti-Triac 6 Pin Dip MOC3011 ISO1 – ISO6
19 3 A 70-04807 Header, 3 Pin Breakaway, Single Row JP2, J4
20 2 10-04001 Header, 4 x 2 Pin JP1
22 1 A 70-04748 Connector, 6 Pin, Molex J1
23 1 A 70-04526 Connector, Header 34 Pin J3
Eureka Progeny Inc.• 1407 Barclay Blvd. •Buffalo Grove, IL 60089

BILL OF MATERIAL 70-08380 MC150 Pinnacle Microcontroller


Rev. G ECN P0890
PAGE 1 OF 3

ITEM QTY DWG PART ITEM DESCRIPTION Vendor Ref.


NO. SIZE NO. CLS Part No. Designator
24 2 A 70-04731 Connector, Header 12 Pin, Right Angle J2, J5
25 6 A 70-03052 Triac MAC97A6 Q1 – Q6
27 4 A 70-00510 Resistor Array, 10 Pin Sip, 10K Ohms RP1, RP2, RP3, RP4

28 1 A 70-00518 Resistor Array, 6 Pin Sip, 1K Ohms 1K RP8


29 1 A 70-00511 Resistor Array, 8 Pin Sip, 10K Ohms 10K RP7
30 3 D 70-00064 Resistor – ¼ Watt, 5% 10K R5,R10,R22
31 1 D 70-00052 Resistor – ¼ Watt, 5% 3.3K R3
32 1 D 70-00062 Resistor, Carbon Film, 1/4W +/- 1% 8.2 K R1
33 5 D 70-00042 Resistor, Carbon Film 1/4W +/- 5% 1K R2, R18, R19, R20,
R21
34 1 A 70-00654-3 Resistor, Var. 5K OHMS Slim Pk Orig. Var 5K R4
35 2 D 70-00071 Resistor - ¼ Watt, 5% 24K R6, R8
36 2 D 70-00028 Resistor, 270 OHMS, ¼ W +/- 5% 270 R7, R9
37 6 A 70-00032 Resistor, 390 OHMS, ¼ W +/- 5% 390 R11 R12, R13, R14,
R15, R17
38 2 A 70-00508 Resistor Array 470HM, 16 Pin Dip RP5, RP6
39 1 D 70-00058 Resistor, Carbon Film ¼ W 5%, 5.6K R16
40 2 A 70-00654-7 Resistor, Var. 10K Ohms R23, R24
41 1 A 70-03359 LM324 Quad Op Amp U1
44 1 A 70-08239 68 Pin Programmed Logic Device Pinnacle U2
45 3 B 70-03161 I.C., Inv. Schmit Trigger, DIP 14 CD40106 U3, U5, U8
PAGE 2 OF 3
Eureka Progeny Inc.• 1407 Barclay Blvd. •Buffalo Grove, IL 60089

BILL OF MATERIAL 70-08380 MC150 Pinnacle Microcontroller


Rev. G ECN P0890

ITEM QTY DWG PART ITEM DESCRIPTION Vendor Ref.


NO. SIZE NO. CLS Part No. Designator
46 1 A 70-03165 2 Wire Serial EEPROM 24C02 U4
48 1 A 70-03303 5 V - 3 Terminal Pos. 7805 U9
49 2 A 70-04778 Heatsink for U9, U10
50 3 A 70-03146 I.C., 16 Pin DIP ULN2003 U6, U7, U11
52 5 B 70-03094 Opto-Isolator MCT62 U13, U14, U15,
U16, U17
54 1 A 70-03154 Crystal, 10 MHz Y1
55 1 A 70-04282 Socket Square for PLCC 68 Pin
56 3 A 70-04217 Socket, 16 Pin Dip U6,U7,U11
57 4 A 70-04216 Socket, 14 Pin Dip U1,U5,U3,U8
58 6 A 70-04222 Socket, 8 Pin Dip U4,13,14,15,16,17
59 7 A 70-04506 Socket, 6 Pin Dip ISO1,2,3,4,5,6,12
60 1 A 70-04295 Switch, Pushbutton S1
61 1 A 26-00830 Screw, 6-32 x ¼ Phillips Pan Hd.
62 1 A 70-11166 Nut, 6-32
64 1 A 70-03302 LM317 Voltage Regulator, Adjustable U10
65 1 A 10-03001 Bridge Rectifier, 100V, 1 AMP D5
66 1 B 70-00700-11 Resistor, Metal Film 1% 237 Ohms 237 R25
67 1 B 70-00700-12 Resistor, Metal Film 1% 2.61K Ohms 2.61K R26

PAGE 3 OF 3
REVISIONS
REV DESCRIPTION DATE APP'D
A RELEASE FOR PRODUCTION 1/9/01 A. KREMA
B ADD LASER CIRCUIT 2/10/02 A. KREMA
MANUFACTURER TO ADD C MOVED ALL COMPONENTS DOWN 1/16" 5/31/02 A. KREMA
REMAINDER OF
ASSEMBLY NUMBER 382. D ECN PO914 Remove IC sockets 9/19/03 A. KREMA

MANUFACTURER TO ADD
SERIAL NUMBER AND
CURRENT REVISION.
NOTES:
1. ALL COLOR CODED RESISTORS TO BE INSERTED WITH TOLERANCE
BAND TOWARD THE BOTTOM OR RIGHT HAND SIDE OF THE PCB.
2. ALL PRINTED RESISTORS TO BE INSERTED WITH THE RESISTANCE
VALUE VISIBLE AND ORIENTED SUCH THAT THE BOTTOM OF THE
TEXT IS TOWARD THE BOTTOM OR RIGHT HAND SIDE OF THE PCB. ORIGINAL PRODUCT
3. ALL CAPACITORS, DIODES, ETC. TO BE INSERTED WITH THE
VALUE AND/OR TYPE VISIBLE AND ORIENTED AS DESCRIBED IN
PROGENY INCORPORATED
NOTE 2.
APPROVALS DATE
4. SCHEMATIC 70-08383 DRN
KT 1/8/01
MC150 PINNACLE
FABRICATION 70-06323
THIS DRAWING IS THE PROPERTY OF AND
CHK
AK 1/9/01
DIGITAL DISPLAY ASSEMBLY
CONTAINS INFORMATION PROPRIETARY TO APP SIZE ITEM CLASS DRAWING NO.
AK 1/9/01
THE PROGENY INCORPORATED. THIS DRAW-
ING SHALL NOT BE REPRODUCED, USED OR B 70-08382
DISCLOSED WITHOUT THE PRIOR WRITTEN
CONSENT OF PROGENY INCORPORATED. SCALE FILENAME:7006323.MAX SHEET 1 OF 1
A B C D E F G H I J K L M N O P Q
REVISIONS
J1-12 REV DESCRIPTION DATE APP'D
11 J1-11 +5V 11
A Production Release
J1-10 A
B
7 A A1 3 C Lamp Sw Wiring 9/27/99
J1-9 6 B A2 8
C 4
U1 D 2
C
+28V
D Change Fab 1/4/00
J1-1 C 1 E 1 D
E SEGc F E DS1 E Add Laser Ckt 2/11/02
2 28 9
J1-2 B 3
SEGe VSS G 10
F
5
10 4
SEGb
27 A G DP 10
J1-3 5
DP SEGa
26 G A 7 3
6 DA0 SEGg 25 D B 6 A A1 8
J1-4 DA1 SEGd F C B A2 1k 1/2W
7 IN_DP SEGf 24 4 C 2.2k 1/2W
8 D 2 1k 1/2W 1k 1/2W
J1-5 9
/WR
23 E 1
D
DS2 R4 LB1
10
HEX DIG3
22 F 9
E R3 LB2
J1-6 11 DA2 DIG6 21 G 10 F 5
R5 LB3 R6 LB4 2 1
ID1 DIG7 G DP A1 C1
12 20 15 16
J1-7 13
ID2 DIG4 A 7 3
A1 C1
15 16 15 16
9 ID3 B A A1 A1 C1 A1 C1 9
J1-8 14 ID4 VDD 19 6 B A2 8 4 C2 A2 3
C 4 C 4 C2 A2 3
J1-29 DIG8 18 D 2 D 4 C2 A2 3 4 C2 A2 3
DIG5 17 E 1 E DS3 R7 6 A3 C3 5
16 F 9 11 12
DIG2
15 G 10
F
5
A3 C3 R8 11 12 R9 11 12
DIG1 G DP 2.2k 1/2W A3 C3 A3 C3
ICM7228C 8 C4 A4 7
A 7 A A1 3 8 C4 A4 7 1k 1/2W 1k 1/2W
B 6 B A2 8 8 C4 A4 7 8 C4 A4 7
8 +5V C 4 C 8
D 2 D 10 A5 C5 9 HLMP-2755
E 1 E DS4 10 A5 C5 9 10 A5 C5 9 1k 1/2W
F 9 F
+28V G 10 G DP 5 5 C6 A6 6 R10 LB5
5 C6 A6 6 5 C6 A6 6
1k 1/2W 2 A1 C1 1
14 A7 C7 13
R11 14 13 14 13
LB6 A7 C7 A7 C7
4 3
7 C2 A2 7
1 C8 A8 2
2 A1 C1 1 A 7 A A1 3 1 C8 A8 2 1 C8 A8 2

/READY
B 6 8 6 5

/MANUAL
/HOLD
C B A2 A3 C3
4
4 3 D 2
C LTL-2785
C2 A2 E 1
D
DS5 LTL-2885 LTL-2785 8 7
F E IN C4 A4
9 J1-13 J1-14
6 5 G 10
F
5 U6E J1-16
A3 C3 G DP J1-15
A 7 3 11 10 HLMP-2755
6 B A A1 CM 6
8 C4 A4 7 6 B A2 8 U6C J1-17
C 4 C
D 2 5 6 CD4106 LAMP_24VAC
E 1
D
DS6 J1-25
HLMP-2755 F 9
E 15V
G F LAMP_24VAC
10 G DP 5 CD4106 U6F J2-4
+28V A 7 3 13 12
J1-21 B 6 A A1 8 U6D R2
C B A2
5 4 C 5
J1-20 D 2 9 8 CD4106 J2-5 24VAC 270
U3 7815 15V E 1
D
DS7 J1-27
F E
9 F
G 10 5 CD4106
GND

IN OUT G DP
R1 Q1
2N2222A
+ C1 C2 22k
J1-18 2.2 Tant + D1
4 D2 1 4
2.2 Tant R12 1k ISO1 DF02 2 J3
AGND

+
J1-19 C3 R13 100TRIAC_GATE
15V 1N750A HEADER 2
15V 0.01 J1-22
15V
R14 15V

-
15V R15 MOC3011
R16 100k C4 24VAC_COM
3 100k U4A J1-23 3
10k 0.1 APPROVALS DATE
C5 2 6 J1-24
C6 T2A Q U5 DRN
4

8
J2-1 U4B 0.1 R17
C7 1 APP
RESET

VCC

LAMP SW T1A 2.2m 5%


0.1 14 T2A Q 10
4538
R18 0.1 4 A CHK
U6A 15 T1A 5 B DISCH 7
47k 7 2
CD

1 2 12 4538 Q TRIG 6 CHK


2 A THRESH 2
47k R19 11 B 3 OUT
C8
3

9 5 PROGENY, Inc.
CD

Q CTL 10 TANT
CD4106 +
GND

0.22 C10 U6B C11 THIS DRAWING IS THE PROPERTY OF AND


13

J2-6 Assembly: 70-08366


0.1 3 4 C9 CONTAINS INFORMATION PROPRIETARYTO
LM555 Fabrication: 70-06323
1

LAMP SW COM 0.01 PROGENY, INC. THIS DRAWING SHALL NOT Title
BE REPRODUCED, USED, OR DISCLOSED,
1 CD4106 WITHOUT THE PRIOR WRITTEN CONSENT OF Display Schematic 1
Size Document Number R ev
PROGENY, INC.
70-08365, 70-08375, 70-08383
Date: Sheet 1 of 1
A B C D E F G H I J K L M N O P Q

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