OmniPod DASH Guide De L'utilisateur page 200

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.
This device complies with the RF Exposure guidelines of Safety Code 6 when used
as directed.
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:
Frequency: 2,400-2,480 GHz, digitally modulated, with an effective radiated
power of 1.14 mW
The Omnipod DASH™ System complies with the immunity requirements of the
general standard for electromagnetic compatibility, IEC 60601-1-2.
The Omnipod DASH™ System has demonstrated immunity to both radio-
frequency identification (RFID) systems and Electronic Article Surveillance
(EAS) systems. Testing has been performed in accordance with AIM 7351731 to
demonstrate this immunity.
Caution: Portable RF communications equipment (including peripherals, such
as antenna cables and external antennas) should be used no closer than 30 cm (12
inches) to any part of the Omnipod DASH™ System. Otherwise, degradation of
the performance of this equipment could result.
Appendix
183
Effective Date: 18OCT2020, PCO-000235