Guidance and Manufacturer's Declaration -
Electromagnetic Immunity
The CooperSurgical Smoke Evacuation Systems are intended for use in the
electromagnetic environment specified below. The customer or the end user of
the CooperSurgical Smoke Evacuation Systems should assure that it is used in
such an environment.
Immunity Test
Electromagnetic
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. In this case 230 V.
T
IEC 60601
Test Level
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for input/output
lines
±1 kV differential mode
±2 kV common mode
<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 sec
3 A/m
Compliance
Level
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV differential
mode
±2 kV common
mode
<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 sec
3 A/m
7
Electromagnetic
Environmental -
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 that of a typical
commercial or hospital
environment. If the user
of the CooperSurgical
Smoke Evacuation
System requires
continued operation
during power mains
interruptions, it is
recommended that the
CooperSurgical Smoke
Evacuation System
be powered from an
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.