Electromagnetic Compatibility - Boston Scientific Precision Montage MRI Informacion Para Medicos

Electromagnetic Compatibility

EN 60601-1-2 Classification Information
• Internally Powered Equipment
• Continuous Operation
• Ordinary Equipment
• Class II
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
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
IEC 60601 Compliance Level
Test Level
± 6 kV contact ± 6 kV contact
± 8 kV air ± 8 kV air
± 2 kV for power ± 2 kV for power
supply lines supply lines
± 1 kV for input/ ± 1 kV for input/
output lines output lines
± 1 kV line(s) to ± 1 kV line(s) to
line(s) line(s)
± 2 kV line(s) to ± 2 kV line(s) to
earth earth
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 the Implantable
Pulse Generator only during the
implant procedure and shipping
and handling.
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.
Precision Montage™ MRI System Information for Prescribers
Safety Information
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