Use Instructions

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ETSI EN 301 489-1 and ETSI EN 301 489-27
GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMMISSIONS OF
THE OPTIMIZER SMART MINI IPG PURSUANT TO:
ETSI EN 301 489-1 V2.2.3 - ElectroMagnetic Compatibility (EMC) standard for radio equipment
and services; Part 1: Common technical requirements; Harmonised Standard for
ElectroMagnetic Compatibility
ETSI EN 301 489-27 - ElectroMagnetic Compatibility (EMC) standard for radio equipment and
services; Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI)
and related peripheral devices (ULP-AMI-P) operating in the 402 MHz to 405 MHz bands;
Harmonised Standard covering the essential requirements of article 3.1(b) of 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
Radiated Emissions
EN 55032:2012/AC:2013
Class B
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.