Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Boston Scientific Spectra WaveWriter Informacion Para Medicos

Guidance and manufacturer's declaration – electromagnetic immunity
The Spectra WaveWriter Spinal Cord Stimulator System is intended for use in the electromagnetic
environment specified 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
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to
(ETS only) 80 MHz
Radiated RF 10 V/m
80 MHz to
IEC 61000-4-3
2,7 GHz
NOTE These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the Spectra™ WaveWriter Spinal Cord Stimulator System is used exceeds the
applicable RF compliance level above, the Spectra WaveWriter Spinal Cord Stimulator System should
be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the Spectra WaveWriter Spinal Cord Stimulator
System.
Compliance Electromagnetic Environment - guidance
Level
3 Vrms Professional healthcare facility environment
and home healthcare environment.
150 kHz to 80
MHz
6 Vrms in ISM
and amateur
radio bands
between 150
kHz and 80
MHz
10 V/m Professional healthcare facility environment
and home healthcare environment.
80 M Hz to
2,7 GHz Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
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:
Spectra Wavewriter™ System Information for Prescribers
Safety Information
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