Use Instructions

40
Electromagnetic Emissions
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 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
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 intended
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 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
ETSI EN 301 839
GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMMISSIONS OF
THE OPTIMIZER SMART MINI IPG PURSUANT TO:
ETSI EN 301 839 V2.1.1 - Ultra Low Power Active Medical Implants (ULP-AMI) and associated
Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Harmonised
Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
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
Compliance
Electromagnetic
environment - guidelines
Frequency Error
Complies with clause 5.3.1
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.
Occupied Bandwidth
Complies with clause 5.3.2
Power Output
Complies with clause 5.3.3
Transmitter Spurious Emissions
(30 MHz to 6 GHz)
Complies with clause 5.3.4
Frequency Stability Under Low
Voltage Conditions
Complies with clause 5.3.5
Spurious Radiation of Receivers
Complies with clause 5.3.6