Electromagnetic Compatibility - Boston Scientific PRECISION MONTAGE MRI Información Para El Pacientes

information for Patients

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 IEC 60601 Test Level
Electrostatic discharge ± 6 kV contact
(ESD) IEC 61000-4-2
± 8 kV air
Electrical fast transient/ ± 2 kV for power supply
burst IEC 61000-4-4 lines
± 1 kV for input/output
lines
Surge IEC 61000-4-5 ± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Precision montage™ mri system information for Patients
91053248-04 reV a 16 of 679
Compliance Level Electromagnetic environment – guidance
± 6 kV contact Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should
± 8 kV air
be at least 30 %.
Note: Applies to the Implantable Pulse Generator only during
the implant procedure and shipping and handling.
± 2 kV for power supply Mains power quality should be that of a typical commercial or
lines hospital environment.
± 1 kV for input/output
lines
± 1 kV line(s) to line(s) Mains power quality should be that of a typical commercial or
hospital environment.
± 2 kV line(s) to earth