1: Introduction; Intended Use; Intended Use For The User Guide; Product Complaints - Hologic Affirm User Manual

Chapter 1:
Introduction
1:
1.1

Intended Use

United States federal law restricts this device to use by, or on the order of, a physician.
The Affirm™ breast biopsy guidance system is an optional accessory for the Selenia®
Dimensions® digital mammography system. 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

Intended Use for the User Guide

Always refer to the User Guide for instructions on using the system.
1.3

Product Complaints

Report any complaints or problem in the quality, reliability, safety, or performance of this
product to Hologic. If the device has caused or added to patient injury, immediately
report the incident to Hologic. (See the title page for contact information.)
1.4

Technical Support

Refer to the title page of this manual for contact information for product support.
1.5

Quality Control

Facilities that are ACR accredited must follow the 1999 Stereotactic Breast Biopsy Quality
Control Manual. Facilities that are not ACR accredited can follow the above manual or
perform the QAS Test described in this manual at the required interval.
1.6

Installation Instructions

Installation instructions are available in the Service Manual.
MAN-03209 Revision 005
Affirm User Guide
Chapter 1: Introduction
Page 1