Guidance And Manufacturer's Declaration - Electromagnetic Immunity; Leep System 1000 ® Electrosurgical Generator Emc Compliance Information - Cooper Surgical LEEP System 1000 Manuel D'utilisation

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The Electrosurgical Generator is intended for use in the electromagnetic environment specified below.
The customer or the end user of the Electrosurgical Generator should ensure 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
* U is the AC mains voltage prior to application of the test level.
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®
LEEP System 1000 Workstation • Model KH1000A • Operating Manual • English
IEC 60601
Test Level
± 6 kV contact ± 6 kV contact
± 8 kV air ± 8 kV air
± 2 kV for power ± 2 kV for power
supply lines supply lines
± 1 kV for input/ ± 1 kV for input/
output lines output lines
± 1 kV differential ± 1 kV differential
mode mode
± 2 kV common ± 2 kV common
mode mode
<5% U * <5% U
T
(>95% dip in U *) (>95% dip in U
T
for 0.5 cycle for 0.5 cycle
40% U * 40% U
T
(60% dip in U *) (60% dip in U
T
for 5 cycles for 5 cycles
70% U * 70% U
T
(30% dip in U *) (30% dip in U
T
for 25 cycles for 25 cycles
<5% U * <5% U
T
(>95% dip in U *) (>95% dip in U
T
for 5 seconds for 5 seconds
3 A/m 3 A/m
Compliance
Level 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
T
*) of a typical commercial or hospital
T
environment. If the user of the
Electrosurgical Generator requires
* continued operation during
T
*) power mains interruptions, it is
T
recommended that the Electrosurgical
Generator be powered from an
* uninterruptible power supply or a
T
*) battery.
T
*
T
*)
T
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
(continued)
Electromagnetic
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