Impulse Dynamics OPTIMIZER Integra CCM-D - Page 54

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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 INTEGRA CCM-D 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 Integra CCM-D Implantable Pulse Generator, part of the OPTIMIZER
Integra CCM-D System, is intended for use in an electromagnetic environment as
specified below. The patient implanted with the OPTIMIZER Integra CCM-D 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 Integra
CCM-D IPG must emit
electromagnetic energy in
order to perform its
intended function when
communicating with the
Intelio Programmer or the
Guardio Charger. Nearby
electronic equipment may
be affected.