430-11902-02 Rev N
Table 14-6 IEC EMC Specifications (Immunity)
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Estech COBRA™ Electrosurgical HF Generator is intended for use in the
electromagnetic environment specified below. The customer or the user of the
Estech COBRA™ Electrosurgical HF 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
IMMUNITY EMC SPECIFICATIONS
IEC 60601
Compliance
test level
level
±6 kV
±6 kV contact
contact
±8 kV air
±8 kV air
±2 kV for
±2 kV for power
power
supply lines
supply lines
±1 kV for
±1 kV for
input/output
input/output
lines
lines
±1 kV
±1 kV
differential
differential mode
mode
±2 kV common
±2 kV
mode
common
mode
<5% UT
<5% UT (>95%
(>95% dip in
dip in UT) for 0.5
UT) for 0.5
cycles
cycles
40% UT (60%
40% UT
dip in UT) for 5
(60% dip in
cycles
UT) for 5
70% UT (30%
cycles
dip in UT) for 25
70% UT
cycles
(30% dip in
<5% UT (>95%
UT) for 25
dip in UT) for 5
cycles
seconds
<5% UT
(>95% dip in
UT) for 5
seconds
Page 41 of 411
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 that of a typical
commercial or hospital
environment. If the user of
the Estech COBRA™
Electrosurgical HF
Generator requires
continued operation during
power mains interruptions,
it is recommended that the
Estech COBRA™
Electrosurgical HF
Generator be powered from
an uninterruptible power
supply or battery.