Table 202 /Table 2
Guidance and manufacturer’s declaration–electromagnetic immunity
The Flexible Intubation Video Endoscope 11302 BDX in conjunction with monitor 8403 ZX is intended for use in the
electromagnetic environment speci fied below. The customer or user of the system should ensure that it is used in
such an environment.
Immunity test
EN IEC 60601 test level
Compliance level
Electromagnetic environment–guidance
Electrostatic Discharge
± 6 kV contact
Complies
Floors should be wood, concrete or
(ESD)
± 8 kV air
± 6 kV contact
ceramic tile.If floors are covered with
IEC 61000-4-2
± 8 kV air
synthetic material, the relative
humidity should be at least 30%.
Electrical fast
± 2 kV for power supply
Complies
Mains power quality should be
transient/burst
lines
± 2 kV for power
that of a typical commercial or
IEC 61000-4-4
± 1 kV for input/
supply lines
hospital environment.
output lines
± 1 kV for input/
output lines
Surge
± 1 kV differential mode
Complies
Mains power quality should be that of IEC
61000-4-5
± 2 kV common mode
± 1 kV differential mode
a typical commercial or hospital
± 2 kV common mode
environment.
Voltage dips, short
<5% U
T
*
Complies
Mains power quality should be that of
interruptions and
(>95% dip in U
T
)
<5% U
T
*
a typical commercial or hospital
voltage variations on
for 0.5 cycle
(>95% dip in U
T
)
environment.
power supply input lines
for.5 cycle.
IEC 61000-4-11
40% U
T
Complies
If the user of the equipment or
(60% dip in U
T
)
40% U
T
system requires continued
for 5 cycles
(60% dip in UT)
operation during power main
for 5 cycles
interruptions, it is recommended
that the equipment or system be
powered from an uninterruptible
power supply
70% U
T
Complies
(30% dip in U
T
)
70% UT
for 25 cycles
(30% dip in U
T
)
for 25 cycles
<5% U
T
Complies
(>95% dip in U
T
)
<5% U
T
for 5 sec
(>95% dip in U
T
)
for 5 sec
Power frequency
3A/m
Complies
Power frequency magnetic fields
(50/60 Hz)
3A/m
should be at levels characteristic
magnetic field
of a typical location in a typical
IEC 61000-4-8
commercial or hospital environment.
* NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
Electromagnetic Compatibility (EMC) Information
54
Содержание 11302 BDX
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