Hologic Affirm, Руководство пользователя

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Affirm User Guide
Chapter 1: Introduction
MAN-03209 Revision 005 Page 3
1.8 Training Requirements
In the United States, users must be Registered Radiologic Technologists meeting criteria
to perform mammography. The mammography users must meet all applicable MQSA
personnel requirements under FDA guidelines for conventional and digital
mammography.
The user has options available for training, which include but are not limited to:
•
Onsite applications training by a Hologic Clinical Services Specialist
• Onsite on the job training also known as peer training
Additionally, the user manual is a guide for directions on how to use the system.
All users must make sure that they receive training on correct operation of the system
before use on patients.
Hologic does not accept the responsibility for injury or damage from wrong system
operation.
1.9 Terms and Definitions
Affirm The breast biopsy guidance system for the Selenia Dimensions
Biopsy Control
Module The user control device for the Affirm breast biopsy guidance
system
Biopsy Guidance
Module Holds and operates the biopsy device. Responds to commands
from the Biopsy Control Module to move the device into position
and do the biopsy.
Comm Communication
Diff Differential
C-Arm Mode Lets the C-arm and Tube Arm to move together to the Needle
Approach angle for the Localization procedure.
Exposure
Technique Combination of x ray parameters (kVp, mAs, filter) for an acquired
image
Needle
Approach Angle The angle of incidence of the needle to the breast
QAS Quality Assurance Standard
Safety Margins The minimum space allowed between the biopsy device needle
that is installed and components of the Selenia Dimensions system.
Stereo Mode Lets the Tube Arm rotate for acquisition of stereotactic images
while the C-arm stays in position.
Stereotactic
Procedure A type of examination that allows stereotactic views at the
Acquisition Workstation.
Stereotactic View A specialized image view that causes the application to capture a
stereotactic images.
Stroke Margin The safety margin (in mm) that remains between the fired needle
position and the breast platform.