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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
the function of medical electrical equipment.
Insulet Corporation declares that the mylife OmniPod Insulin
Management System is in compliance with the essential require-
ments 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).
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.
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.
The mylife OmniPod System communicates with the following
characteristics:
Frequency: 433 MHz, FSK modulation, with an effective radi-
ated power of 13mW
The mylife OmniPod System greatly exceeds the immunity
requirements of the general standard for electromagnetic com-
patibility, IEC 60601-1-2.
Electromagnetic Emissions
This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure
that is used in such an environment.
Emissions
Compliance according to
Electromagnetic environment
RF Emissions (CISPR 11)
Group 2
The Pod and the PDM emit low level electromagnetic energy (RF) in
order to communicate. Although unlikely, nearby electronic equip-
ment may be affected.
CISPR B
Emissions Classification
Class B
The System is suitable for use in all establishments including domestic
establishments.
Summary of Contents for mylife OmniPod
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