Electromagnetic Immunity - Boston Scientific Vercise Mode D'emploi

Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Table 2: Guidance and Manufacturer's Declaration

Electromagnetic Immunity

The Boston Scientific DBS System is intended for use in the electromagnetic environment specified below.
The customer or the user of the Boston Scientific DBS System should assure that it is used in such an
environment.
IEC 60601‑1‑2
Immunity Test
Test Level
Air:
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV
Electrostatic discharge
(ESD) IEC 61000‑4‑2
Contact:
± 8 kV
± 2 kV for power
Electrical fast transient/
supply lines
burst IEC 61000‑4‑4
(Programming Wand
± 1 kV for input/output
only)
lines
Surge IEC 61000‑4‑5
± 1 kV line(s) to line(s)
(Programming Wand
± 2 kV line(s) to earth
only)
±
1 15 kV compliance level applies to Vercise ETS 3 only.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
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Compliance Level
Air:
Remote Control and
Charger: ± 2 kV, ± 4 kV,
± 8 kV, ± 15 kV
ETS and Wand: ± 2 kV,
± 4 kV, ± 8 kV, ± 15 kV
1
Contact:
Remote Control, Charger,
and ETS 3: ± 8 kV
ETS 2 and Wand: ± 6 kV
± 2 kV for power
supply lines
± 1 kV for input/output
lines
± 1 kV line(s) to line(s)
± 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 external
electrical components.
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.