BTG Visual-ICE, Руководство пользователя

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8-4 User Manual
Table 8-3. Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The Visual-ICE Cryoablation System is intended for use in the electromagnetic environment specified below.
The customer or the user of the Visual-ICE System should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
±1 kV for input/
output lines
± 2 kV for power
supply lines
±1 kV for input/output
lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % U
T
(>95 % dip in
U
T
) for
0,5 cycle
40 %
U
T
(60 % dip in U
T
) for
5 cycles
70 % U
T
(30 % dip in
U
T
) for
25 cycles
<5 % U
T
(>95 % dip in
U
T
)
for 5 s
>95 % dip in
U
T
for
0,5 cycle
60 % dip in U
T
for 5
cycles
30 % dip in
U
T
for 25
cycles
>95 % dip in U
T
for 5 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the Visual-
ICE System requires continued
operation during power mains
interruptions, it is recommended that
the Visual-ICE System be powered
from an uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.