Affirm Breast Biopsy Guidance System User Guide
Chapter 1: Introduction
MAN-06411-002 Revision 003 Page 1
1: Introduction
Read all this information carefully before operating the system. Follow all warnings and
precautions as stated in this manual. Keep this manual available during procedures.
Physicians should tell patients about all potential risks and adverse events described in
this manual with respect to the operation of the system.
Note
Hologic configures some systems to meet specific requirements. Your system
configuration may not have all the options and accessories included in this manual.
1.1 Intended Use
Caution: United States federal law restricts this device to sale by or on the order of a
physician.
The Affirm
®
breast biopsy guidance system is an optional accessory for the Selenia
®
Dimensions
®
and 3Dimensions™ digital mammography and digital tomosynthesis
systems. Its function is to localize lesions accurately in the breast in three dimensions. It
is intended to provide targeting guidance for interventional procedures such as biopsy,
presurgical localization, or treatment devices.
1.2 User Profiles
1.2.1 Mammography Technologist
• Meets all requirements that apply to the location in which the Mammography
Technologist operates.
• Completed training on the mammography system.
• Has training in mammography positions.
• Understands stereotactic breast biopsy procedures.
• Understands how to operate a computer and its peripherals.
• Can lift 20 pounds to shoulder height with two hands (necessary for upright
stereotactic systems).
• Understands sterile procedures.
1.2.2 Radiologists, Surgeons
• Meets all requirements that apply to the location in which the Physician operates.
• Understands stereotactic breast biopsy procedures.
• Understands how to operate a computer and its peripherals.
• Understands sterile procedures.
• Gives local anesthesia.
• Understands basic surgical procedures for core biopsy.
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