1: Introduction; Intended Use; Intended Use For The User Guide; System Capabilities - Hologic Trident 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 Trident™ specimen radiography system is a cabinet x-ray system used to provide
digital x-ray images of surgical and core biopsy specimens from various anatomical
regions in order to allow rapid verification that the correct tissue has been excised during
the biopsy procedure.
Doing the verification in the same room as the procedure or nearby improves workflow,
thus reducing the time the patient needs to be under examination.
1.2

Intended Use for the User Guide

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

System Capabilities

The Hologic
and core specimens taken from various anatomical regions. The system has the capability
to transfer the images to external devices. The images acquired with this system are
intended to confirm removal of a suspected lesion or pathology; the system is not
intended for diagnostic purposes.
Specimen radiography systems are used in diagnostic imaging departments, pathology
departments, or in surgical suites. Radiologic Technologists, surgical personnel, surgeons,
radiologists and pathologists can use specimen radiography equipment.
Hologic recommends that users receive training in basic ionizing radiation safety before
using the system.
1.4

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.)
1.5

Technical Support

Refer to the title page of this manual for contact information for product support.
MAN-02098 Revision 008
Trident system acquires and displays the radiographic images of surgical
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Trident User Guide
Chapter 1: Introduction
Page 1