Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Boston Scientific Precision Montage MRI Informacion Para Medicos

Guidance and manufacturer's declaration – electromagnetic immunity
The Precision Montage MRI System is intended for use in the electromagnetic environment specified
below. The customer or the user of the Precision Montage MRI 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 Precision Montage MRI System is used exceeds the applicable RF compliance
level above, the Precision Montage MRI 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 Precision Montage MRI 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 MHz to
Field strengths from fixed RF transmitters,
2,7 GHz
as determined by an electromagnetic site
survey
level in each frequency range. Interference
may occur in the vicinity of equipment
marked with the symbol shown below:
Precision Montage™ MRI System Information for Prescribers
, should be less than the compliance
a
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Safety Information