Electromagnetic Compatibility - Insulet Omnipod Dash User Manual

If the Omnipod DASH™ System does cause harmful interference to radio and
television reception, the interference may be corrected by using one of the
following measures:
• Move or relocate the Omnipod DASH™ System.
• Increase the distance between the Omnipod DASH™ System and the other
device that is emitting or receiving interference.
Insulet Corporation declares that the Omnipod DASH™ System is in compliance
with the essential requirements and other relevant provisions of the Radio
Equipment Directive (2014/53/EU). The full Declaration of Conformity can be
found at the following web address: www.myomnipod.com. This ISM device
complies with Canadian ICES-003 and IC-RSS-210.

Electromagnetic Compatibility

The information contained in this section (such as separation distances) is, in
general, specifically written with regard to the Omnipod DASH™ 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 susceptible 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. If the Omnipod DASH™ System fails due to electromagnetic
disturbances, you may need to replace it.
Portable and mobile radio frequency (RF) communications equipment can affect
the functioning of medical electrical equipment.
Caution: Cables and accessories not specified within the instructions for use
are not authorised. Using other cables or accessories may adversely impact
safety, performance and electromagnetic compatibility (increased emission and
decreased immunity).
Care should be taken if the Omnipod DASH™ System is used adjacent to
other electrical equipment; if adjacent use is inevitable, such as in working
environments, the Omnipod DASH™ System should be observed to verify normal
operation in this setting.
The Omnipod DASH™ System communicates via low-level RF energy. As with
all RF receivers, the potential for disturbance exists, even with equipment that
complies with FCC and CISPR emissions requirements.
The Omnipod DASH™ System communicates with the following characteristics:
Appendix
Effective Date: 27SEP2019, ECO-000240
183