Kodak Kodak DryView 8600, Руководство пользователя

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Section 4 – Quality Control Procedures
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2000 March Rev. B 8186546
Section 4 – Quality Control Procedures
Compliance Guidance – Quality Control for Laser Imagers used in
Digital Mammography Systems
These Quality Control Procedures are intended to provide guidance for
mammography facilities and their personnel. They represent the equipment
manufacturer ’s views on the appropriate procedures for conducting Quality Control
tests for digital mammography and observing the Mammography Quality Standards
Act (MQSA). The following procedures represent acceptable ways of doing the tests,
but unlike regulations, they are not binding. Alternate procedures may be used if
they satisfy the requirements of the applicable statute, regulations, or both. It is the
responsibility of the mammography facility to read, understand, and follow the
regulations.
Under its own authority, a state may impose requirements more stringent than those
imposed in the FDA Mammography Quality Standards Act. A facility should check
with state or local authorities regarding their requirements.
Automatic Image Quality Control and the QC Process
The Kodak DryView 8600 Laser Imager / for Mammography has a built-in Automatic
Image Quality Control (AIQC) system that automatically compensates for film lot
variations, ensuring consistent print densities. The MQSA requires that the
mammography facility establish a quality control (QC) process that verifies the
effectiveness of the AIQC system. Kodak’s recommendations below are based on
the MQSA and the QC process described in the Radiologic Technologist’s Section of
the Mammography Quality Control Manual,
W
1999, published by the American
College of Radiology. This QC process has been adapted to apply to the special
features of Kodak DryView Mammography Laser Imaging Film and the
characteristics of the Kodak DryView 8600 Laser Imager. The procedures outlined
below assume that the user has been trained in operation of the Kodak DryView
8600 Laser Imager.
Running a QC Baseline Test
Per the MQSA, a baseline test must be run when the 8600 is first installed, and must
be repeated every time a box of film with a different emulsion number is used. This
test sets up a baseline set of film parameter values that shall be used as a standard
for comparison in daily quality control tests. Kodak recommends the procedure
described below as a means of complying with this regulation.