About Compression

The Decision to Use Compression

Note: DR Systems provides technology to facilitate your practice, but is not in the practice of medicine. Decisions regarding data compression and archiving of information must be made by local medical professionals and staff cognizant of standard-of-care, professional guidelines, as well as Federal, State, and local regulatory requirements.

Important information about using compression:

· The decision to enable compression is your responsibility and should be based on radiologist supervision, periodic review of appropriate standards and scientific literature.

· Compression may or may not alter diagnostic ability. We recommend you adopt a written policy, review it periodically and adhere to it.

· Note: While we can share the experiences of our customers, DR Systems does not specifically endorse any particular data compression scheme.

Compression for Mammography

When Compression is Applied

Compression can be applied at the time of image acquisition / archive / web distribution.

FDA Regulations about Image Compression

According to FDA regulations, if image compression is applied, only lossless image compression algorithms can be used. The FDA defines lossless compression as follows: Lossless compression refers to methods of digital data compression in which all original data information is preserved and can be completely reconstituted.

About this Form

Sign and date each page of this form to indicate:

· Which types of compression (if any) you want to enable.

· That you have received a copy of the Mammography Compression Request Form, and understand that you are responsible for reading the information described in this form.

Fax Instructions

Please fax this Compression Request Form to:

Service Coordinator
DR Systems, Inc.
Fax: (858) 625-3337

Contacting Customer Support

If you have questions regarding the content or interpretation of this form, contact:

DRSystemsCustomerSupport.

Phone: 1-800-794-5955
Fax: 1-858-625-3337
Email:

Compression Options at Image Acquisition

This setting determines the compression when the image is acquired. It affects primary reading and archiving.

Default compression is Lossless JPEG

Compression Options at Archive

This setting is for primary archive of digital mammography exams.

Warning about selecting no compression:
Selecting no compression will result in a significant increase in storage size when archiving an image of this modality.

Modality / Type of Compression to Apply -Select One /
MG
(MAMMOGRAPHY) / Lossless JPEG
Lossless JPEG 2000
To select no compression, print or type the following: “I reject FDA permitted lossless compression.”
Printed Statement:

Compression Options for Web distribution (Web Ambassador / Web Browser)

Modality / WEB AMBASSADOR / WEB BROWSER
None / Lossless JPEG
/ Lossless JPEG 2000 / Lossy JPEG 2000 / Lossy JPEG / Lossy JPEG
MG / Compression Ratio: / Q Factor: / Q Factor:

Compression Options for Digitized Film

The mammography digitizer cleared by the FDA works like a modality, such as a CT scanner. It does not use the digitizer software built into the DR Systems PACS. Typically, the digitized images come in through the DICOM Gateway, so compression must be specified in the configuration settings.

Modality / Type of compression to apply -- Select one
None / Lossless JPEG
/ Lossless JPEG 2000 / Lossy JPEG 2000 / Lossy JPEG
MG (MAMMOGRAPHY) / Compression Ratio: / Q Factor:

Archiving Mammography CAD SR findings

The decision to archive or not to archive CAD findings requires special attention. Regulatory and legal requirements currently do not address this issue specifically. However, you need to carefully consider the decision to archive or to discard CAD findings.

Do you want to archive CAD information? / Yes / No
Signature: / Date: / Site ID:
Signature Page
Compression Request Form
For Mammography

Authorized Signature - Senior Radiologist, PACS Administrator or Director of Radiology

The undersigned authorizes DR Systems to institute the requested configuration variables selected in this form, acknowledges the responsibility of having gained the consensus of appropriate medical personnel, and also acknowledges responsibility for validation of appropriate configuration immediately subsequent to DR Systems’ implementation of the configuration requested in this form.

I am authorized to make the configuration requests in this form, and will verify the proper implementation of these requests:

Printed Name / Signature
Title / Date
Site Name / Site Number

For the DR Service Representative to complete

Printed Name – DR Service Representative / Signature – DR Service Representative
Completion Date / Heat Ticket #

FRM: SVC-000224-C

Confidential

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the advance written permission of Merge Healthcare Incorporated.