Boston Scientific Precision Montage, Информация для врачей-прескриберов

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Safety Information
Precision Montage™ MRI System Information for Prescribers
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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 Compliance Level Electromagnetic
environment
– guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
Air:
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV
Contact:
± 8 kV
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
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.
Electrical fast transient/
burst IEC 61000-4-4
(Programming
Wand only)
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge IEC 61000-4-5
(Programming
Wand only)
± 1 kV line(s)
to line(s)
± 2 kV line(s) to earth
± 1 kV line(s)
to line(s)
± 2 kV line(s) to earth
Mains power quality
should be that of a
typical commercial or
hospital environment.