Brevera Breast Biopsy System User Guide
Chapter 2: General Information
Page 14 MAN-04303-002 Revision 006
2.4 Interlocks
The x-ray generation stops automatically and a system message or alert appears when
there is an interruption of an x-ray exposure. (Examples of x-ray interruptions include:
the mAs timer or maximum exposure timer times out, the tissue filter drawer is opened,
or the key switch is turned to the locked position.) To make another exposure:
1. Select the OK button in the system message dialog box.
2. Select the status icon (shaped like the Brevera breast biopsy console) in the taskbar at
the bottom of the Imaging display screen.
3. Complete any action (such as "close the drawer") that shows in the system message
area of the Imaging display screen.
4. Select the Clear All Faults option.
2.5 Compliance
This section describes the system compliance requirements and the responsibilities of the
manufacturer.
2.5.1 Compliance Requirements
The manufacturer has the responsibility for the safety, reliability, and performance of this
equipment with the following provisions:
• The equipment is used according to the instructions for use.
• The assembly operations, extensions, adjustments, changes, or repairs are performed
only by authorized persons.
• The network and communication equipment must be installed to meet IEC
Standards.
Caution:
This system is intended for use by healthcare professionals only. This system may
cause radio interference or may disrupt the operation of nearby equipment. It may be
necessary to take mitigation measures, such as re-orienting or relocating the
equipment or shielding the location.
Caution:
The emissions characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for
which CISPR 11 class B is normally required), this equipment might not offer
adequate protection to radio-frequency communication services. The user may need
to take mitigation measures, such as relocating or re-orienting the equipment.
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