63
Appendix
Vedlegg:
Anhang
Electromagnetic Compatibility (EMC)
Information
Hinweise zur elektromagnetischen
Verträglichkeit (EMV)
Table 202
Guidance and manufacturer’s declaration – electromagnetic immunity
The flexible CMOS Video-Cysto-Urethroscope 11272 V/VU in conjunction with monitor 8402 ZX is intended for use in the electromagnetic environment
specified below. The user should ensure that it is used in such an environment.
Immunity test
EN/IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Electrostatic Discharge (ESD)
acc. to IEC 61000-4-2
± 6 kV contact
± 8 kV air
Complies
± 6 kV contact
± 8 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
acc. to IEC 61000-4-4
± 2 kV for power supply
lines
± 1 kV for input/output lines
Complies
± 2 kV for power supply lines
± 1 kV for input/output lines
Mains power 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.
Surge acc. to IEC 61000-4-5
± 1 kV differential mode
± 2 kV common mode
Complies
± 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 acc. to IEC 61000-
4-11
<5% U
T
*
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
Complies
<5% U
T
*
(>95% dip in U
T
)
for 0.5 cycle
Complies
40% U
T
(60% dip in U
T
)
for 5 cycles
Complies
70% U
T
(30% dip in U
T
)
for 25 cycles
Complies
<5% U
T
(>95% dip in U
T
)
for 5 sec
Mains power quality should be that of a typical commercial or
hospital environment.
If the user of the equipment or system requires continued
operation during power mains interruptions, it is
recommended that the equipment or system be powered
from an uninterruptible power supply or a battery.
Power frequency (50/60
Hz) magnetic field acc. to
IEC 61000-4-8
3 A/m
Complies
3 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
* Note: U
T
is the a.c. mains voltage prior to application of the test level.
Merknader om elektromagnetisk
kompatibilitet (EMC)
