Impulse Dynamics OPTIMIZER Integra CCM-D - Page 53

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ETSI EN 301 839
GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC
EMMISSIONS OF THE OPTIMIZER INTEGRA CCM-D 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 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
Frequency Error
Complies with clause 4.2.1.1
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.
Occupied Bandwidth
Complies with clause 4.2.1.2
Power Output
Complies with clause 4.2.1.3
Transmitter Spurious
Emissions (30 MHz to
6 GHz)
Complies with clause 4.2.1.4
Frequency Stability Under
Low Voltage Conditions
Complies with clause 4.2.1.5
Spurious Radiation of
Receivers
Complies with clause 4.2.2.1