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2.3 Printer QC (Technologist)
2.3.1 Test Objective
To ensure that the laser printer used to produce hard copies for nal interpretation is performing according to the
manufacturer's specications.
FDA recommends the use of devices that have been approved by the FDA Oce of Device Evaluation for use in Full
Field Digital Mammography. Follow the manufacturer's QC guidelines for devices that have received this clearance.
Contact the manufacturer of your device for their QC manual and for questions concerning clearance status.
2.3.2 Frequency
• Initially before interpreting mammograms
• ON ANY DAY prior to printing patient images, or at the frequency suggested by the printer manufacturer's QC
guideline, whichever is more frequent
• After any service or maintenance on the printer and whenever problems are suspected
Follow the QC manual by your printer manufacturer.
2.3.3 Required Equipment
• QC pattern (e. g. SMPTE pattern)
• Calibrated densitometer
Additional equipment may be needed. Follow the QC manual by your printer manufacturer.
2.3.4 Procedure
Follow the Printer manufacturer's QC manual to print the QC pattern and measure the optical density as specied.
Perform any other tests such as spatial resolution check or geometric delity test if directed in the manufacturer's QC
manual.
2.3.5 Performance Criteria and Corrective Action
Performance Criteria: Follow the manufacturer's QC manual. Contact the manufacturer of your printer for details.
Corrective Action: Follow the manufacturer's QC manual. Contact the manufacturer of your printer for details.
The source of the problem shall be identied and corrective action shall be taken before further mammographic im-
age interpretation is performed by use of that printer. Patient imaging may be continued. If available, an alternative
approved diagnostic device may be used for mammographic image interpretation.
2.3.6 Documentation
Follow the manufacturer's QC manual.
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