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Hologic Selenia - 2.4 Emergency Off Switches; 2.6 Compliance

Hologic Selenia
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Selenia User Guide
Chapter 2General Information
14 MAN-03270 Revision 003
2.4 Emergency Off Switches
The Emergency Off switches remove the power from the Gantry. Do not normally use the
Emergency Off switches to turn off the system. (See Emergency Off Switches on page 23.)
2.5 Interlocks
Display of 58 Newtons (13 lb) or greater of compression force disables the C-arm
vertical drive and rotation.
Installation of a Localization Paddle disables the automatic compression release
functions.
Release of an X-ray button before the end of the exposure ends the exposure.
Misalignment of the Light Field Mirror or the Filter prevents an x-ray exposure.
Installation of an 18 x 24 cm shifting paddle prevents the x-ray exposure if the
detected paddle position does not match the View.
2.6 Compliance
This section describes the mammography system compliance requirements and the
manufacturer responsibilities.
2.6.1 Compliance Requirements
The manufacturer is responsible for the effects of safety, reliability, and performance of
this equipment with the following provisions:
The electrical installation of the room complies with the appropriate requirements.
The equipment is used in accordance with the User Guide.
Assembly operations, extensions, re-adjustments, modifications, or repairs are
performed by authorized persons only.
The installed network and communications equipment must comply with an IEC
Standard, and the complete system (network/communications equipment and Selenia
Mammography System) must be installed to comply with IEC 60601-1 and IEC
60601-1-1.
Caution:
Medical Electrical Equipment needs special precautions
about EMC and must be installed, put into service and
used according to the EMC information provided.
Caution:
Portable and mobile RF communications can affect
medical electrical equipment.

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