Page no. 4
Regulatory.fm
GE Healthcare
Senographe SecondLook Digital CAD System
Revision 1
Operator Manual 5189820-5-C-1EN
Regulatory requirements
Electromagnetic Compatibility (EMC)
This equipment complies with :
• FCC/ICES-003
• CISPR 22
• EN55022, EN55024
• EN61000-3-2, EN610003-3
• VCCI
• AS/NZS 3548
• BSMI CNS13438
• GOST R 29216-91, GOST R 50628-95
• Belarus License
• Ukraine License
• RRL MIC Notice No. 1997-41 (EMC) & 1997-42 (EMI)
• GB 9254, GB 17625 - CNCA Certification
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 emissions as per CISPR22 , Class A standard limits.
Detailed requirements and recommendations about power supply distribution and installation are
listed in the Pre-Installation Manual (pim) shipped with your system. However, 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
interference.
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 published specifications. Recommended separation distances are detailed in the Pre-
Installation Manual (pim) shipped with your system. Keep the power to this type 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 Manual (pim) shipped with your system. Note
that the magnetic field of an MRI device located nearby may cause a risk of interference.
