QRS -101 Bedienungsanleitung Seite 43

N O T E S I N A C C O R D A N C E W I T H E C - D I R E C T I V E
A N D M E D I C A L D E V I C E D I R E C T I V E ( M D D )
In accordance with the EMC-regulations for medical products we are obliged by law to provide the
following information.
Guidance and manufacturer's declaration – electromagnetic emissions
The equipment is intended for use in the electromagnetic environment specifi ed below. The customer or the user
of the equipment should assure that it is used in such an environment.
Emissions test
RF emissions, CISPR 11
RF emissions, CISPR 11
Harmonic emissions,
IEC 61000-3-2 (*)
Voltage fl uctuation/fl icker emissions,
IEC 61000-3-3 (*)
(*) Note: For devices with a power consumption between 75 W and 1000 W only.
Guidance and manufacturer's declaration – electromagnetic immunity
The equipment is intended for use in the electromagnetic environment specifi ed below. The customer or the user
of the equipment should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD),
IEC61000-4-2
Electrical fast
transient/burst,
IEC 61000-4-4
Surge,
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines,
IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic fi eld,
IEC 61000-4-8
Note: U is the a.c. mains voltage prior to application of the test level.
τ
Compliance
Group 1
Class B
Class A
Complies
IEC 60601 - test level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV phase-to-phase
conductors
±2 kV phase-to-earth
<5% U for ½ cycle
τ
(>95% dip)
40% U for 5 cycles
τ
(60% dip)
70% U for 25 cycles
τ
(30% dip)
<95% U for 5 s
τ
(>5% dip)
3 A/m
Electromagnetic environment – guidance
The equipment 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 equipment is suitable for use in all
establishments, including domestic establish-
ments 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 phase-to-phase
conductors
±2 kV phase-to-earth
<5% U for ½ cycle
τ
(>95% dip)
40% U for 5 cycles
τ
(60% dip)
70% U for 25 cycles
τ
(30% dip)
<95% U for 5 s
τ
(>5% dip)
3 A/m
Electromagnetic environment –
guidance
Floors should be wood, concrete or
ceramic tile. If fl oors are covered
with synthetic material, the relative h
umidity should be at least 30%.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
If the user of the equipment requires
continued operation during power
mains interruptions, it is recommended
that the equipment be powered from
an uninterruptible power supply or a
battery.
Power frequency magnetic
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
GB
fi elds
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