Trident HD Specimen Radiography System User Guide
Chapter 1: Introduction
MAN-05478-002 Revision 003
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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
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 System Capabilities
The Trident system acquires and displays the radiographic images of surgical 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.
1.3 User Profiles
•
A Primary System User (for example, an operating room nurse) can perform basic
system functions, except ones that require Manager privileges. The Primary System
User is referred to in this document as the User.
•
System Managers can perform all system functions, add and delete user accounts, and
delete patients. The System Manager is referred to in this document as the Manager.
•
Service personnel have full access to all system functions.
Chapter 1
