Boston Scientific Precision Montage MRI Informacion Para Medicos página 15

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
Electrostatic discharge
(ESD) IEC 61000-4-2
Electrical fast transient/
burst IEC 61000-4-4
(Programming
Wand only)
Surge IEC 61000-4-5
(Programming
Wand only)
IEC 60601 Test Level
Air:
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV
Contact:
± 8 kV
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV line(s)
to line(s)
± 2 kV line(s) to earth
Compliance Level
Air:
Remote Control
and Charger:
± 2 kV, ± 4 kV,
± 8 kV, ± 15 kV
ETS and Wand:
± 2 kV, ± 4 kV, ± 8 kV
Contact:
Remote Control and
Charger: ± 8 kV
ETS and Wand:
± 6 kV
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV line(s)
to line(s)
± 2 kV line(s) to earth
Precision Montage™ MRI System Information for Prescribers
Safety Information
Electromagnetic
environment
– guidance
Floors should be
wood, concrete
or ceramic tile. If
floors are covered
with synthetic
material, the relative
humidity should
be at least 30 %.
Note: Applies to
external devices.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Mains power quality
should be that of a
typical commercial or
hospital environment.
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