Hologic 3Dimensions - Potential Adverse Effects of Mammography Systems on Health

3Dimensions System User Guide
Chapter 1: Introduction
Page 2 MAN-05085-002 Revision 002
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1.2 Potential Adverse Effects of Mammography Systems on
Health
Below is a list of the potential adverse effects (such as complications) associated with the
use of the device (these risks are the same as for other screen-film or digital
mammography systems):
• Excessive breast compression
• Excessive x-ray exposure
• Electric shock
• Infection
• Skin irritation, abrasions, or puncture wounds
1.3 System Capabilities
The system provides the user interfaces for the performance of screening and diagnostic
mammograms:
• Conventional mammography with a digital image receptor equivalent in size to large
mammography film.
• Tomosynthesis scan with a digital image receptor equivalent in size to large
mammography film (Tomosynthesis option).
• Conventional digital mammogram and tomosynthesis scan during one compression
(Tomosynthesis option).
1.4 About the Genius 3D Mammography Exam
The Genius™ 3D Mammography™ exam (also known as Genius™ exam) is acquired on
a Hologic
®
3D Mammography™ system, and has a 2D and 3D™ image set. The 2D image
can be either an acquired 2D image or a 2D image generated from the 3D™ image set.
The Genius™ exam is only available on a Hologic
®
3D Mammography™ system.
Genius™ 3D Mammography™ is the brand name of a Hologic 3D Mammography™
exam, and may not be available in all markets.