Insulet Corporation 017 Manuale Utente
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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.
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.
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.
medical electrical equipment.
Insulet Corporation declares that the OmniPod Insulin Manage-
ment System is in compliance with the essential requirements
and other relevant provisions of Directive 1999/5/EC.
ment System is in compliance with the essential requirements
and other relevant provisions of Directive 1999/5/EC.
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).
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 System is used adjacent to other elec-
trical equipment; if adjacent use is inevitable, such as in work
environments, the System should be observed to verify normal
operation in this setting.
trical equipment; if adjacent use is inevitable, such as in work
environments, the System should be observed to verify normal
operation in this setting.
The System communicates by low level RF energy. As with all RF
receivers, the potential for disturbance exists, even with equip-
ment that complies with FCC and CISPR emissions requirements.
receivers, the potential for disturbance exists, even with equip-
ment that complies with FCC and CISPR emissions requirements.
The OmniPod System communicates with the following
characteristics:
characteristics:
Frequency: 433 Mhz, FSK modulation, with an effective radi-
ated power of 13mW
ated power of 13mW
The OmniPod System greatly exceeds the immunity require-
ments of the general standard for electromagnetic compatibility,
IEC 60601-1-2.
ments of the general standard for electromagnetic compatibility,
IEC 60601-1-2.