Product Info

Electromagnetic Compatibility
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
92366224‑01 17 of 29
Table 2: Guidance and Manufacturer’s Declaration
Electromagnetic Immunity
The Boston Scientic DBS System is intended for use in the electromagnetic environment specied below.
The customer or the user of the Boston Scientic DBS System should assure that it is used in such an
environment.
Immunity Test
IEC 60601‑1‑2
Test Level
Compliance Level
Electromagnetic
Environment – Guidance
Electrostatic discharge
(ESD) IEC 61000‑4‑2
Air:
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV
Contact:
± 8 kV
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
Floors should be wood,
concrete or ceramic tile.
If oors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
Note: Applies to external
electrical components.
Electrical fast transient/
burst IEC 61000‑4‑4
(Programming Wand
only)
± 2 kV for power
supply lines
± 1 kV for input/output
lines
± 2 kV for power
supply lines
± 1 kV for input/output
lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge IEC 61000‑4‑5
(Programming Wand
only)
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Mains power quality
should be that of a typical
commercial or hospital
environment.
1 ± 15 kV compliance level applies to Vercise ETS 3 only.