Guidance and manufacturer’s declaration- electromagnetic immunity
This product is intended for use in the electromagnetic environment specified below. The customer or the
user of this product 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
± 8 kV contact
± 2, 4, 8, 15 kV air
± 8 kV contact
± 2, 4, 8, 15 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
100 kHz repetition frequency
± 2 kV for power supply lines
± 1 kV for input /output lines
100 kHz repetition frequency
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000 - 4 - 5
± 1 kV differential mode
± 2 kV common mode
± 1 kV differential mode
± 2 kV common mode
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
(>95 % dip in U
T
)
for 0.5 cycle
Single phase:
0°, 45°, 90°, 135°, 180°, 225°,
270°, 315°
40 % U
T
(0 % dip in U
T
)
for 1 cycle
70 % U
T
(30 % dip in U
T
)
for 25/ 30 cycle (0.5 s)
Single phase: 0°
<0 % U
T
(>95 % dip in U
T
)
for 250/ 300 cycle (5 s)
(>95 % dip in U
T
)
for 0.5 cycle
Single phase:
0°, 45°, 90°, 135°, 180°, 225°,
270°, 315°
40 % U
T
(0 % dip in U
T
)
for 1 cycle
70 % U
T
(30 % dip in U
T
)
for 25/ 30 cycle (0.5 s)
Single phase: 0°
<0 % U
T
(>95 % dip in U
T
)
for 250/ 300 cycle (5 s)
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of this
product requires continued operation
during power mains interruptions, it
is recommended that this product be
powered from an uninterruptible power
supply or a battery.
Power frequency
(50 / 60 Hz) magnetic
field IEC 61000 - 4 - 8
30 A / m
50 Hz or 60 Hz
30 A / m
50 Hz or 60 Hz
It is recommended that this product be
used apart from other devices operated
with large current.
Note: U
T
is the a.c. mains voltage prior to application of the test level.
Conducted RF
IEC 61000 - 4 - 6
3 Vrms
150 kHz to 80 MHz
6 V in ISM bands
80 % AM at 1 kHz
3 Vrms
150 kHz to 80 MHz
6 V in ISM bands
80 % AM at 1 kHz
Radiated RF
IEC 61000 - 4 - 3
3 V/ m
80 MHz to 2.7 GHz
80 % AM at 1 kHz
3 V/ m
80 MHz to 2.7 GHz
80 % AM at 1 kHz
Case 7 Description of Endoscopes Class B
86
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