3Dimensions System User Guide
Chapter 2: General Information
Page 18
MAN-05085-002 Revision 002
DRAFT
Preview Copy-Generated May 30, 2018
2.5
Interlocks
The 3Dimensions system has safety interlocks:
•
C-arm vertical movement and rotation are disabled when compression force is
applied. A Service Engineer can configure the lockout force from 22 Newtons (5
pounds) to 45 Newtons (10 pounds).
•
If the x-ray button or x-ray footswitch is released before the end of the exposure, the
exposure stops and an alarm message is displayed.
•
When in Tomo mode, the system does not allow an exposure if the Grid is in the x-
ray field (Tomosynthesis option).
•
Mirror and Filter position flags also prevent x rays when the Light Field Mirror or the
Filter Assembly is not correctly positioned.
2.6
Compliance
This section describes the mammography system compliance requirements and the
responsibilities of the manufacturer.
2.6.1
Compliance Requirements
The manufacturer has the responsibility for the safety, reliability, and performance of this
equipment with the following provisions:
•
The electrical installation of the room meets all requirements.
•
The equipment is used according to the
User Guide
.
•
The assembly operations, extensions, adjustments, changes, or repairs are performed
only by authorized persons.
•
The network and communication equipment is installed to meet IEC Standards. The
complete system (network and communications equipment and the mammography
system) must be in compliance with IEC 60601-1.
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.
Caution:
The use of unauthorized accessories and cables can result in increased emissions or
decreased immunity. To keep the isolation quality for the system, attach only
approved Hologic accessories or options to the system.
