Affirm Breast Biopsy Guidance System User Guide
Chapter 2: General Information
Page 10 MAN-06411-002 Revision 003
Warning:
The user must schedule preventive maintenance by an approved Service
Engineer.
Warning:
The user or a Service Engineer must correct problems before the system is
used.
Warning:
Do not leave the patient unattended during the procedure.
Warning:
Keep the hands of the patient away from all buttons and switches at all times.
Caution:
To prevent damage or misalignment, be careful when you move the Affirm system.
Caution:
The Affirm Biopsy Guidance Module weighs 15 pounds. When you move it, be sure
to have a secure grip on the handles.
Note
The system does not have any parts that are serviced by the user.
2.5 Compliance
This section describes the system compliance requirements and the responsibilities of the
manufacturer.
2.5.1 Compliance Requirements
The manufacturer is responsible for the effects of safety, reliability, and performance of
this equipment, with the following provisions:
• The equipment is used in accordance with the User Guide.
• Assembly operations, extensions, re-adjustments, modifications, or repairs are
performed by authorized persons only.
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