Electromagnetic Emissions From The Optimizer Smart Mini Ipg - Impulse Dynamics OPTIMIZER Smart Mini Patient Manual

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