Appendix
152
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mylife OmniPod System Notice
Concerning Interference
The mylife OmniPod Insulin Management System (both the Pod
and the Personal Diabetes Manager or PDM) complies with Part
15 of the FCC Rules. Operation is subject to the following two
conditions:
1. These devices may not cause harmful interference.
2. These devices must accept any interference received, includ-
ing interference that may cause undesirable operation.
Changes or modifications not expressly approved by Insulet
could void the user’s authority to operate the equipment.
Both the Pod and the PDM generate, use, and can radiate radio
frequency energy, and may cause harmful interference to radio
communications. There are no guarantees that interference will
not occur in a particular installation. If the mylife OmniPod Sys-
tem does cause harmful interference to radio and television
reception, the interference may be corrected by one of the fol-
lowing measures:
•
Move or relocate the mylife OmniPod System.
•
Increase the distance between the mylife OmniPod System
and the other device that is emitting or receiving interfer-
ence.
Insulet Corporation declares that the mylife OmniPod System is
in compliance with the essential requirements and other rele-
vant provisions of Directive 1999/5/EC. This ISM device complies
with Canadian ICES-003 and IC-RSS-210.
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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
mylife OmniPod System. The numbers provided will not guaran-
tee 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.
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).
Summary of Contents for OmniPod my life
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