Impulse Dynamics OPTIMIZER Integra CCM-D - Electromagnetic Emissions; Ipg

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Electromagnetic Emissions
Electromagnetic Emissions from the OPTIMIZER
Integra CCM-D IPG
The OPTIMIZER Integra CCM-D IPG must emit
electromagnetic energy in order to perform its intended
function when communicating with the Intelio Programmer
or the Guardio Charger. Nearby electronic equipment may
be affected.
FCC 47 CFR 95 Subpart I - Medical Device Radio Communications
Service
GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC
EMMISSIONS OF THE OPTIMIZER INTEGRA CCM-D IPG PURSUANT TO:
FCC 47 CFR 95 Subpart I – Medical Device Radio Communications Service
The OPTIMIZER Integra CCM-D Implantable Pulse Generator, part of the OPTIMIZER
Integra CCM-D System, is intended for use in an electromagnetic environment as
specified below. The patient implanted with the OPTIMIZER Integra CCM-D Implantable
Pulse Generator must ensure that it is used within the specified environment.
Emissions Test
Compliance
Electromagnetic
environment –
guidelines
Duration of Transmissions
Complies with clause 95.2557
The OPTIMIZER Integra
CCM-D IPG must emit
electromagnetic energy in
order to perform its
intended function when
communicating with the
Intelio Programmer or the
Guardio Charger. Nearby
electronic equipment may
be affected.
Frequency Monitoring
Complies with clause 95.2559
Frequency Accuracy
Complies with clause 95.2565
EIRP
Complies with clause
95.2567(a)
Field Strength
Complies with clause 95.2569
Bandwidth
Complies with clause 95.2573
Unwanted Emissions
Complies with clause 95.2579
Permissible Exposure
Evaluation
Complies with clause 95.2585