Affirm Breast Biopsy Guidance System User Guide
Chapter 1: Introduction
Page 2 MAN-06411-002 Revision 003
1.2.3 Medical Physicist
• Meets all requirements that apply to the location in which the Medical Physicist
operates.
• Understands mammography.
• Has experience with digital imaging.
• Understands how to operate a computer and its peripherals.
1.3 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 incorrect system
operation.
1.4 Quality Control Requirements
Perform all Quality Control tests within the correct time frame.
1.5 Where to Find Technical Description Information
Technical description information is available in the Service Manual.
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