Electromagnetic Compatibility
Clinician Manual
97035873-01 69 of 75
Guidance and manufacturer’s declaration – electromagnetic immunity
The Spectra WaveWriter Spinal Cord Stimulator System is intended for use in the electromagnetic environment
specied below. The customer or the user of the Spectra WaveWriter Spinal Cord Stimulator System should assure
that it is used in such an environment.
Immunity Test IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment - guidance
Conducted RF
IEC 61000-4-6
(ETS only)
3 Vrms
150 kHz to
80 MHz
3 Vrms
150 kHz to
80 MHz
6 Vrms in ISM
and amateur
radio bands
between 150 kHz
and 80 MHz
Professional healthcare facility environment and home
healthcare environment.
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to
2,7 GHz
10 V/m
80 MHz to
2,7 GHz
Professional healthcare facility environment and home
healthcare environment.
Field strengths from xed RF transmitters, as determined
by an electromagnetic site survey,
a
should be less than the
compliance level in each frequency range. Interference may
occur in the vicinity of equipment marked with the symbol
shown below:
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