User's Manual

Appendices
152
■ Electromagnetic Compatibility
The information contained in this section (such as separation
distances) is, in general, specifically written with regard to the
OmniPod System. The numbers provided will not guarantee
faultless operation but should provide reasonable assurance of
such. This information may not be applicable to other medical
electrical equipment; older equipment may be particularly sus-
ceptible to interference.
General Notes
Medical electrical equipment requires special precautions
regarding electromagnetic compatibility (EMC) and needs to be
installed and put into service according to the EMC information
provided in this document and the instructions for use.
Portable and mobile RF communications equipment can affect
medical electrical equipment.
Cables and accessories not specified within the instructions for
use are not authorized. Using other cables and/or accessories
may adversely impact safety, performance, and electromagnetic
compatibility (increased emission and decreased immunity).
Care should be taken if the OmniPod is used adjacent to other
electrical equipment; if adjacent use is inevitable, such as in work
environments, the OmniPod should be observed to verify nor-
mal operation in this setting.
The OmniPod communicates by low level RF energy. As with
all RF receivers, the potential for disturbance exists, even with
equipment that complies with FCC and CISPR emissions require-
ments. The OmniPod communicates with the following charac-
teristics:
Frequency: 13.56 Mhz, ASK modulation, with an effective
radiated power of 16mW
The OmniPod System greatly exceeds the immunity require-
ments of the general standard for electromagnetic compatibility,
IEC 60601-1-2.