Impulse Dynamics OPTIMIZER Smart Mini Patient Manual page 54

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
Frequency Error
Occupied Bandwidth
Power Output
Transmitter Spurious
Emissions (30 MHz to
6 GHz)
Frequency Stability Under
Low Voltage Conditions
Spurious Radiation of
Receivers
ETSI EN 301 839
Compliance
Complies with clause 5.3.1
Complies with clause 5.3.2
Complies with clause 5.3.3
Complies with clause 5.3.4
Complies with clause 5.3.5
Complies with clause 5.3.6
48
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.