Hologic Selenia - Chapter 1 Introduction; 1.1 Intended Use and Safety

Selenia User Guide
Chapter 1—Introduction
MAN-03270 Revision 003 1
Chapter 1
Chapt er 1 Introduction
The Selenia
®
, based on the M-IV
TM
Mammography X-ray System, uses an Image
Acquisition system that includes a digital image receptor. This receptor, which covers an
area of 24 cm x 29 cm, is a direct-capture detector using an amorphous selenium
photoconductor. At the Acquisition Workstation the user selects x-ray exposure technique
factors, adds patient identification data, acquires, processes, and displays the digital
images. The images are then either processed for printing and transmitted to peripheral
hard copy laser film printer or sent to a diagnostic review workstation or both. Contrast
and brightness are set automatically and can be adjusted by the user prior to printing or
viewing. Hard-copy printers and a diagnostic review workstation are available as options.
The patient is prepared for the procedure in the same manner as for a film-based system.
The Acquisition Workstation provides direct digital acquisition system advantages in
system efficiency and productivity including:
• Patient demographics are associated with the electronic image.
• Technologist comments can be associated with the image.
• The technologist is assisted through the steps of image acquisition.
• Possible image destinations are provided via configurable settings.
• The technologist may review past acquisitions (including priors) to see previous
captures, and then resend and/or remark them.
1.1 Intended Uses
United States federal law restricts this device to use by, or on the order of, a physician.
The Selenia is intended to produce radiographic images of the breast. Its intended use is
for the production, storage, and diagnostic review of digital screening, diagnostic, and
needle localization mammography.
The system is to be used in a radiology or clinic exam room environment in a hospital,
outpatient clinic, or a breast imaging center. Mammography technologists operate the
system for the production and storage of digital mammograms. The system may also be
used for quality control purposes and other clinical or research related activities by
medical physicists and radiologists certified in accordance with MQSA standards.
• The Selenia Acquisition Workstation display is not approved for final interpretation
of examinations. Final interpretations should be done from either films or with the
diagnostic review workstation. Images shown on the Acquisition Workstation display
are for quality assurance or confirmation purposes only.
• Only images produced by recommended laser printers, or an approved diagnostic
review workstation, should be used for final interpretation of examinations. For
compatible printers, see the latest product data sheets for the system, which can be
obtained from Hologic® or your sales representative.