Affirm Breast Biopsy Guidance System User Guide
Chapter 2: General Information
MAN-06411-002 Revision 003 Page 9
2.3 Safety Information
Read and understand this manual before you use the system. Keep the manual available
during the patient procedures.
Always follow all the instructions in this manual. Hologic does not accept the
responsibility for injury or damage from incorrect system operation. Hologic can
schedule training at your facility.
The system has protective devices, but the Technologist must understand how to safely
use the system. The Technologist must remember the health hazards of x rays.
Do not connect this equipment to any system or component not described in this manual.
A combination of components must have the data to validate the safety of the patient,
personnel, and the environment. Any additional certification becomes the responsibility
of the user.
2.4 Warnings and Precautions
WARNING!
After power failure, remove the patient from the system before you
apply power.
Warning:
You make x rays when you use the procedures in this manual.
Warning:
C-arm movement is motorized.
Warning:
The Tube Arm movement is motorized.
Warning:
Only qualified users can use this system.
Warning:
Only physicians and providers trained in percutaneous biopsy procedures
can use this system.
Warning:
Do not use this equipment if any faults or problems are detected.
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