Boston Scientific Precision Montage MRI Informacion Para Medicos página 15

Guidance and manufacturer's declaration – electromagnetic immunity
The Precision Montage MRI Spinal Cord Stimulator System is intended for use in the electromagnetic
environment specified below. The customer or the user of the Precision Montage MRI 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
80 MHz
Radiated RF 3 V/m
IEC 61000-4-3 80 MHz to
2,5 GHz
Compliance Level Electromagnetic Environment -
guidance
Portable and mobile RF communications
equipment should be used no closer
to any part of the Precision Montage
MRI Spinal Cord Stimulator System,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
3 Vrms d=1.2√P
150 kHz to 80 MHz
Outside ISM and
amateur radio
bands
a
6 Vrms d=0.58√P
150 kHz to 80 MHz
Inside ISM and
amateur radio
bands
a
10 V/m d=0.35 √P 80 MHz to 800 MHz
80 MHz to 2,5 GHz d=0.70 √P 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Precision Montage™ MRI System Information for Prescribers
Safety Information
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