Boston Scientific Vercise Mode D'emploi page 24

Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Table 3: 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
Conducted RF 3 Vrms
IEC 61000‑4‑6
150 kHz to 80 MHz
(ETS only)
10 V/m
Radiated RF
IEC 61000‑4‑3
80 MHz to 2,7 GHz
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the Boston Scientific DBS System is used exceeds the applicable RF compliance level above, the Boston
Scientific DBS System should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re‑orienting or relocating the Boston Scientific DBS System.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
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Electromagnetic Environment
Compliance Level
‑ Guidance
3 Vrms Professional healthcare facility
environment and home healthcare
150 kHz to 80 MHz
environment.
6 Vrms in ISM and
amateur radio bands
between 150 kHz
and 80 MHz
Professional healthcare facility
environment and home healthcare
environment.
Field strengths from fixed RF
transmitters, as determined by an
10 V/m electromagnetic site survey
be less than the compliance level in
80 MHz to 2,7 GHz
each frequency range. Interference
may occur in the vicinity of equipment
marked with the symbol shown below:
, should
a