P/N MAN-01964 Revision 001 xiii
DRAFT
Preview copy—Generated 7/9/2010
User Manual
Preface
Intended Use
Preface
1.0 Intended Use
The Hologic Selenia
®
Dimensions
®
Digital Breast Tomosynthesis System generates digital
mammographic images that can be used for screening and diagnosis of breast cancer. The
Selenia Dimensions system is intended for use in the same clinical applications as Full Field
Digital Mammography systems for screening mammograms. Specifically, the Selenia
Dimensions system can be used to acquire two-dimensional full field digital mammograms
and three-dimensional tomosynthesis mammograms. The screening examination will consist
of a two-dimensional image set or a two-dimensional and tomosynthesis image set. The
Selenia Dimensions system may also be used for additional diagnostic workup of the breast.
2.0 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).
3.0 Users
• A Technologist to acquire and review images
• A Technologist with the manager
permissions to perform the Quality Assurance
• A system administrator to enable permissions
• A Medical Physicist to perform the Quality Control tests
• A Radiologist can use the system with a Technologist
• The service personnel to install the system, set the site system configurations and
calibrations, and find faults
4.0 Skills Needed for System Use
You must know how to do the following:
• Perform the trackball operations, like click, drag, and/or select
• Perform the touchscreen operations
• Select from menus
• Type information in text fields
• Select the options in the screens
• Select the entries from drop-down lists
• Use scroll bars
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