GE Senographe DS Operator's Manual page 4

GE Healthcare
Revision 1
Regulatory Requirements
Electromagnetic Compatibility (EMC)
This equipment complies with IEC60601-1-2 Edition 2 EMC standard for medical devices.
This equipment generates, uses, and can radiate radio frequency energy. The equipment may cause
radio frequency interference to other medical and non-medical devices and radio communications.
To provide reasonable protection against such interference, this product complies with radiated emis-
sions as per CISPR11 Group 1 Class A standard limits.
Detailed requirements and recommendations about power supply distribution and installation are
listed in the Pre-Installation section of the Service Documentation shipped with your system. How-
ever, there is no guarantee that interference will not occur in a particular installation.
If this equipment is found to cause interference (which may be determined by turning the equipment
on and off), the user (or qualified service personnel) should attempt to correct the problem by one or
more of the following measure(s):
- reorient or relocate the affected device(s)
- increase the separation between the equipment and the affected device
- power the equipment from a source different from that of the affected device
- consult the point of purchase or service representative for further suggestions
The manufacturer is not responsible for any interference caused by using other than recommended
interconnect cables or by unauthorized changes or modifications to this equipment. Unauthorized
changes or modifications could void the users' authority to operate the equipment.
All interconnect cables to peripheral devices must be shielded and properly grounded. Use of cables
not properly shielded and grounded may result in the equipment causing radio frequency interfer-
ence.
Do not use devices which intentionally transmit RF Signals (Cellular Phones, Transceivers, or Radio
Controlled Products) in the vicinity of this equipment as it may cause performance outside the pub-
lished specifications. Recommended separation distances are detailed in the Pre-Installation section
of the Service Documentation shipped with your system. Keep the power to these types of devices
turned off when near this equipment.
The medical staff in charge of this equipment is required to instruct technicians, patients, and other
people who may be around this equipment to comply fully with the above requirement.
Further data and recommendations for meeting Electromagnetic Compatibility requirements for a
typical installation are given in the Pre-Installation section of the Service Documentation shipped with
your system. Note that the magnetic field of an MRI device located nearby may cause a risk of inter-
ference. Magnetic field amplitude limits are specified in the Pre-Installation section of the Service
Documentation shipped with your system.
Senographe DS Acquisition System
Page no. 4
Operator Manual 5307907-3-S-1EN
regulatory.fm