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Appendix
EMC
Guidelines and manufacturer's declaration – electromagnetic immunity
The flexible video cysto-urethroscope 11272VUE/VUE-R in combination with the compatible CCU is designed for operation in an electromagnetic environment as
defined below. The user should make sure that it is used in such an environment.
Interference immunity tests
Electrostatic discharge (ESD) acc.
±6 kV contact discharge
to IEC 61000-4-2
±8 kV air discharge
± 2 kV for power supply
Electrical fast transient/burst acc. to
lines
IEC 61000-4-4
±1 kV for input and output
lines
± 1 kV differential mode
Surges acc. to IEC 61000-4-5
±2 kV common mode
<5% U
(>95% dip in U
for ½ cycle
40% U
(60% dip in U
Voltage dips, short interruptions
for 5 cycles
and fluctuations of the supply
voltage acc. to IEC 61000-4-11
70% U
(30% dip in U
for 25 cycles
<5% U
(>95% dip in U
for 5 seconds
Magnetic field at the
supply frequency (50/60 Hz)
3 A/m
acc. to IEC 61000-4-8
* Note: U
is the a.c. mains voltage prior to application of the test level.
T
Annexe
CEM
Table 2
EN/IEC 60601 test level
Compliance level
Complies
±6 kV contact discharge
±8 kV air discharge
Complies
± 2 kV for power supply
lines
±1 kV for input and output
lines
Complies
± 1 kV differential mode
±2 kV common mode
Complies
<5% U
T*
(>95% dip in U
T*
)
T
for ½ cycle
Complies
40% U
T
T
)
(60% dip in U
T
for 5 cycles
Complies
T
)
70% U
T
T
(30% dip in U
for 25 cycles
T
)
Complies
T
<5% U
T
(>95% dip in U
for 5 seconds
Complies
3 A/m
Anexo
CEM
Electromagnetic environment – guidelines
Floors should be made of wood, concrete or covered
with ceramic tiles. If floors are covered with synthetic
material, the relative humidity must be at least 30%.
The power supply quality should be that of a typical
commercial or hospital environment. If image
distortion occurs, it may be necessary to further filter
the power quality by using an AC line filter.
The power supply quality should be that of a typical
commercial or hospital environment.
)
T
The power supply quality should be that of a typical
)
commercial or hospital environment.
T
If the user of the device requires continued operation
during power supply interruptions, it is recommended
that the device be powered from an uninterruptible
)
power supply.
T
)
T
The magnetic fields at the mains frequency should
be at the values typical of business or hospital
environments.
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