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Boston Scientific Vercise DB-1110-C Manual página 74

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Vercise™ DBS Physician Manual
Electromagnetic Compatibility
EN 60601-1-2 Classification Information
Internally powered
Continuous operation
Ordinary equipment
Class II
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
The Vercise DBS System is intended for use in electromagnetic environment specified below. The customer or the
user of the Vercise DBS System should ensure that it is used in such an environment.
Emissions Test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000‑3‑2
Voltage fluctuations/
flicker emissions
IEC 61000‑3‑3
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Vercise DBS System is intended for use in the electromagnetic environment specified below. The customer or the
user of the Vercise DBS System should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Air:
± 2 kV, ± 4 kV,
± 8 kV, ± 15 kV
Electrostatic
discharge (ESD)
Contact:
IEC 61000‑4‑2
± 8 kV
Power frequency
(50/60 Hz)
30 A/m
magnetic field
IEC 61000‑4‑8
Vercise™ DBS Physician Manual
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70 of 341
Compliance
Electromagnetic Environment – Guidance
The Vercise DBS System uses RF energy only for its
internal function. Therefore, its RF emissions are very
Group 1
low and are not likely to cause any interference in nearby
electronic equipment.
Class B
The Vercise DBS System is suitable for use in all
Not Applicable
establishments, including domestic establishments and
those directly connected to the public low voltage power
supply network that supplies buildings used for domestic
Not Applicable
purposes.
Compliance Level
Air:
Remote Control and Charger:
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV
ETS:
± 2 kV, ± 4 kV, ± 8 kV
Contact:
Remote Control and Charger:
± 8 kV
ETS:
± 6 kV
30 A/m
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
devices.
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.

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