Electromagnetic Compatibility - En 60601-1-2 Classification Information - Boston Scientific Spectra WaveWriter 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 Spectra WaveWriter Spinal Cord Stimulator System is intended for use in the electromagnetic
environment specified below. The customer or the user of the Spectra WaveWriter 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
(Programming Wand
only)
Surge IEC 61000-4-5
(Programming Wand
only)
IEC 60601 Test Level Compliance Level
Air: ± 2 kV, ± 4 kV, Air:
± 8 kV, ± 15 kV
Remote Control and
Contact: ± 8 kV 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 ± 2 kV for power
supply lines supply lines
± 1 kV for input/output ± 1 kV for input/
lines output lines
± 1 kV line(s) to line(s) ± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
± 2 kV line(s) to 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
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.
Spectra Wavewriter™ System Information for Prescribers
92089818-02
Safety Information
13 of 443