Boston Scientific Vessix Generator Mode D'emploi page 13

table 2: Guidance and manufacturer's declaration – electromagnetic immunity
The Vessix™ Generator is intended for use in the electromagnetic environment specified below. The customer or the
user of the Vessix Generator 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)
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
(IEC 61000-4-11)
Power frequency (50/60 Hz)
magnetic field
(IEC 61000-4-8)
NOTE U is the a.c. mains voltage prior to application of the test level.
t
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/ ± 1 kV for input/
output 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
< 5% U (> 95% dip < 5% U
t
in U ) for 0.5 cycle in U
t t
40% U (60% dip in U ) 40% U
t t
for 5 cycles for 5 cycles
70% U (30% dip in U ) 70% U
t t
for 25 cycles for 25 cycles
< 5% U (> 95% dip < 5% U
t
in U ) for 5 s in U
t t
3 A/m 3 A/m
13
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%.
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.
Mains power quality should be
(> 95% dip that of a typical commercial or
t
) for 0.5 cycle hospital environment. If the user
(60% dip in U ) of the Vessix Generator requires
t t
continued operation during
(30% dip in U ) power mains interruptions, it is
t t
recommended that the Vessix
(> 95% dip Generator be powered from an
t
) for 5 s uninterruptible power supply or
a battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
Black (K) ∆E ≤5.0