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Table 2: Guidance and Manufacturer's Declaration
Electromagnetic Immunity
The Vercise Genus DBS System is intended for use in the electromagnetic environment described below. The customer or user of the Vercise
Genus DBS System should ensure that it is used in such an environment.
Immunity Test
IEC 60601‑1‑2 Test Level
Air:
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV
Electrostatic discharge
(ESD) IEC 61000-4-2
Contact:
± 8 kV
Power frequency
(50/60 Hz)
30 A/m
magnetic field
IEC 61000-4-8
Note: The Charger is used with a rechargeable DBS System only.
Compliance Level
Air:
Remote Control and Charger:
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV
Contact:
Remote Control and Charger:
± 8 kV
30 A/m
Electromagnetic Compatibility
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 electrical components.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a typical
commercial or hospital environment. Magnetic fields
from common appliances are not expected to affect
the device.
Information for Patients
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