Impulse Dynamics AIM HIGHer OPTIMIZER, Patient Manual

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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
Service
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 OPTIMIZE
R 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 Compliance Electromagnetic
environment -
guidelines
Duration of Transmissions
Complies with clause 95.2557
The OPTIMIZER Smart
Mini IPG must emit
electromagnetic energy in
order to perform its
int
ended function when
communicating with the
Intelio Programmer or the
Vesta
Charger. Nearby
electronic equipment may
be affected.
Frequency Monitoring
Complies with clause 95.2559
Frequency Accuracy
Complies with clause 95.2565
EIRP
Complies with cla
use
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