Boston Scientific Vercise Genus Bedienungsanleitung Seite 40

Vercise Genus Deep Brain Stimulation System
TM
Table 3: 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
10 V/m
Radiated RF
IEC 61000-4-3
80 MHz to 2,7 GHz
Note: These guidelines may not apply in all situations. Absorption and reflection from structures, objects, and people affects electromagnetic
propagation.
a Field strengths from fixed transmitters cannot be predicted theoretically with accuracy. This includes base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast. 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 Vercise
Genus DBS System is used exceeds the applicable RF compliance level above, the Vercise Genus DBS System should be observed to verify normal
operation. If abnormal performance is observed, more measures may be needed, such as re-orienting or relocating the Vercise Genus DBS System.
Information for Patients
92694767-14 34 of 255
Compliance Level Electromagnetic Environment ‑ Guidance
Professional healthcare facility environment and home
healthcare environment.
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey
10 V/m
compliance level in each frequency range. Interference may
80 MHz to 2,7 GHz
occur in the vicinity of equipment marked with the symbol shown
below:
, should be less than the
a