Use Instructions
299
Appendix
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 5 System fails due to electromagnetic
disturbances, you may need to replace it.
Portable and mobile radio frequency (RF) communications equipment can aect
the function of medical electrical equipment.
Caution: Cables and accessories not specied within the instructions for use
are not authorized. 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 5 System is used adjacent to other electrical
equipment; if adjacent use is inevitable, such as in work environments, the
Omnipod 5 System should be observed to verify normal operation in this setting.
e Omnipod 5 System communicates by 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.
e Omnipod 5 System communicates with the following characteristics:
Frequency: 2.400-2.480 GHz, digitally modulated, with an eective radiated
power of 1.14mW
e Omnipod 5 System complies with the immunity requirements of the general
standard for electromagnetic compatibility, IEC 60601-1-2.
Caution: Portable RF communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer than 12 inches
(30 cm) to any part of the Omnipod 5 System. Otherwise, degradation of the
performance of this equipment could result.
Electromagnetic Emissions
is equipment is intended for use in the electromagnetic environment specied below. e
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
e Pod, controller, and CGM emit low
level electromagnetic energy (RF) in order
to communicate. Although unlikely, nearby
electronic equipment may be aected.
Effective Date: 22DEC2020, PCO-000267