Specifications

This manual contains information for the assembly, installation, adjustment, testing
and maintenance of the LINEAR series of radiographic/fluoroscopic collimators
manufactured by Progeny, Inc.
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 FD-2579 Assemblers Report where applicable.
You assume responsibility for compliance of this product if you fail to follow the original
manufacturer’s instructions or modify any component which affects radiation safety.
The FDA (BRH) requires that manufacturers must include a specific requirement that
the assembler perform all applicable tests at the time of installation. A thorough
explanation of the equipment required and step-by-step instructions must be provided
by the manufacturer. The instructions include a requirement to record key data to
demonstrate at a later time that all tests were performed and that the equipment was left
in full compliance with the standards.
As an assembler, you must perform these tests for the applicable requirements at the
time of installation and following any repairs which could alter the performance.
A Compliance Data Log is provided in this manual to record the results of the tests.
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 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.
November 2005 ( 1 -4 ) Linear MC150-C Collimator