Impulse Dynamics OPTIMIZER Smart Mini Instructions For Use Manual page 141

GUIDELINES AND MANUFACTURER'S DECLARATION – ELECTROMAGNETIC EMMISSIONS OF
THE INTELIO PROGRAMMER WITH INTELIO PROGRAMMING WAND 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 Intelio Programmer with Intelio Programming Wand, part of the OPTIMIZER Smart Mini System, is
intended for use in an electromagnetic environment as specified below. The customer or user of the
Intelio Programmer must ensure that it is used within the specified environment.
Emissions Test
Frequency Error
Emission Bandwidth
Effective radiated power of the
fundamental emission
Spurious Emissions
Frequency Stability Under Low
Voltage Conditions
Spurious Radiation of Receivers
Spectrum Access
Receiver Blocking
GUIDELINES AND MANUFACTURER'S DECLARATION – ELECTROMAGNETIC EMMISSIONS OF
THE INTELIO PROGRAMMER WITH INTELIO PROGRAMMING WAND 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 V2.2.1 – 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 Intelio Programmer with Intelio Programming Wand, part of the OPTIMIZER Smart Mini System, is
intended for use in an electromagnetic environment as specified below. The customer or user of the
Intelio Programmer must ensure that it is used within the specified environment.
There may be potential difficulties in ensuring electromagnetic compatibility in other environments, due
to conducted as well as radiated disturbances.
Emissions Test
Radiated Emissions
Conducted Emissions
Harmonic Current
Emissions
Voltage Fluctuations
ETSI EN 301 839
Compliance
Complies with clause 4.2.1.1
Complies with clause 4.2.1.2
Complies with clause 4.2.1.3
Complies with clause 4.2.1.4
Complies with clause 4.2.1.5
Complies with clause 4.2.2.1
Complies with clause 4.2.3.1
Complies with clause 4.2.3.2
ETSI EN 301 489-1 and ETSI EN 301 489-27
Basic Standard
EN 55032
EN 55032
IEC 61000-3-2
IEC 6100-3-3
131
environment – guidelines
The Intelio Programmer with
Intelio Programming Wand
must emit electromagnetic
energy in order to perform its
intended function. Nearby
electronic equipment may be
affected.
Compliance
environment – guidelines
N/A – covered by The Intelio Programmer with
relevant radio Intelio Programming Wand
standards must emit electromagnetic
energy in order to perform its
Pass
intended function. Nearby
Pass
electronic equipment may be
affected.
Pass
Electromagnetic
Electromagnetic