Impulse Dynamics AIM HIGHer OPTIMIZER, Patient Manual

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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
in
tended function when
communicating with the
Intelio Programmer or the
Vesta
Charger. Nearby
electronic equipment may
be affected.
Wireless Technology
RF wireless technology is used in the communication between an
OPTIMIZER Smart Mini
Implantable Pulse Generator (IPG) and
the Vesta
Charger. It occurs through an encrypted channel over
an RF link that complies with the requirements of the Medical
Implant Communication System (MICS) (range specified to 2 m,
402–
405 MHz) of the MedRadio Band.
RF wireless technology is also used to transcutaneously transmit
energy from the Vesta Charger to recharge the OPTIMIZER
Smart Mini
IPG at the 13.56 MHz ISM frequency. The
transmission range is specified at a maximum of 4 cm between
the C
harger’s coil and the IPG’s receivi
ng coil. Control over the
recharge process, as well as the communications of alert
messages from the IPG to the Charger take place over the
encrypted MICS channel.