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w WARNING
Guidance and
manufacturer's
declaration -
electromagnetic
emissions
Emissions test
Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2 Class A
Voltage fluctuations/
Complies
flicker emissions
IEC 61000-3-3
Immunity test
IEC 60601-1-2 test level
Electrostatic
± 6 kV contact
discharge (ESD)
± 8 kV air
IEC 61000-4-2
Electrical fast
± 2 kV for power supply
transient/burst IEC
lines
61000-4-4
±1 kV for input/output
lines
Surge IEC 61000-
± 1 kV differential mode
4-5
±2 kV common mode
Voltage dips, short
< 5 % UT (> 95% dip in U
interruptions and
for 0,5 cycle
voltage variations
40 % U
on power supply
for 5 cycles
input lines
70 % U
IEC 61000-4-11
for 25 cycles
< 5% U
for 5 sec
1009-0633-000
An operator of the medical electrical system must not touch non-
medical electrical equipment and the patient simultaneously. This
may cause an unsafe electrical shock to the patient.
The system is suitable for use in the specified electromagnetic environment.
The customer and/or the user of the system should assure that it is used in an
electromagnetic environment as described below.
Electromagnetic environment guidance
The system uses RF energy only for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in nearby electronic equipment.
The system is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Compliance level
± 6 kV contact
± 8 kV air
± 2 kV for power supply
lines
±1 kV for input/output
lines
± 1 kV differential
mode
±2 kV common mode
)
< 5 % UT (> 95% dip in
T
U
) for 0,5 cycle
T
(60% dip in U
)
40 % U
T
T
T
U
) for 5 cycles
T
(30% dip in U
)
70 % U
T
T
T
U
) for 25 cycles
T
(> 95 % dip in U
)
< 5 % U
T
T
U
) for 5 sec
T
6 Specifications and Theory of Operation
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 and/or hospital environment.
Mains power quality should be that of a typical
commercial and/or hospital environment.
Mains power quality should be that of a typical
commercial and/or hospital environment. If the
user of the system requires continued operation
(60% dip in
during power mains interruptions, it is
recommended that the system be powered from an
(30% dip in
uninterruptible power supply or a battery.
(> 95% dip in
T
6-9
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