Boston Scientific Precision Novi Manual Del Usuario página 14

Information for Prescribers
Guidance and manufacturer's declaration – electromagnetic immunity
The Precision Novi System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Precision Novi 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
(Programming Wand
only)
Surge IEC 61000-4-5
(Programming Wand
only)
Precision Novi™ System Information for Prescribers
90962628-03 10 of 445
IEC 60601 Test Level Compliance Level
Air: Air:
± 2 kV, ± 4 kV, ± 8 kV, Remote Control:
± 15 kV ± 2 kV, ± 4 kV,
± 8 kV, ± 15 kV
Contact:
ETS and Wand:
± 8 kV
± 2 kV, ± 4 kV, ± 8 kV
Contact:
Remote Control:
± 8 kV
ETS and Wand:
± 6 kV
± 2 kV for power ± 2 kV for power
supply lines supply lines
± 1 kV for input/output ± 1 kV for input/
lines output 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
external devices.
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.