Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Boston Scientific Vercise Gevia Instrucciones De Uso

Vercise Gevia™ Information for Prescribers
Guidance and manufacturer's declaration – electromagnetic immunity
The Vercise Gevia DBS System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Vercise Gevia DBS System should assure that it is used in such an environment.
Immunity Test
Electrostatic discharge
(ESD) IEC 61000-4-2
Electrical fast transient/
burst IEC 61000-4-4
Surge IEC 61000-4-5
Vercise Gevia™ Information for Prescribers
91168753-02 Rev A 12 of 505
IEC 60601 Test Level Compliance Level
± 6 kV contact ± 6 kV contact
± 8 kV air ± 8 kV air
± 2 kV for power supply ± 2 kV for power supply
lines lines
± 1 kV for input/output ± 1 kV for input/output
lines lines
± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s)
± 2 kV line(s) to earth ± 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 the
Implantable pulse
Generator only during the
implant procedure and
shipping and handling.
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.