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Verfügbare Sprachen
83
Electromagnetic Emissions and Immunity
The device complies with all the requirements foreseen by the IEC 60601-1-2:2014 (4
the previous edition: IEC 60601-1-2:2007 (3
rd
Edition).
WARNINGS
• The use of parts other than those supplied or listed as accessory may negatively affect EMC
EMC Tables
performance.
• Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the device,
including cables. Otherwise, degradation of the performance of this equipment could result.
The device is intended for use in the environments specified in Chapter 3 and Basic Safety is maintained
in the electromagnetic environment specified below.
Electromagnetic emissions compliance
Emission test
Conformity
Electromagnetic environment - guidance
The device uses RF energy only for its internal function.
RF Emissions
Group 1
Therefore, its RF emissions are very low and are not likely to
Cispr 11
cause any interference in nearby electronic equipment.
The emissions characteristics of this equipment make it
suitable for use in professional healthcare facilities and
hospitals. If it is used in a residential environment, this
RF Emissions
Class A
equipment might not offer adequate protection to radio-
Cispr 11
frequency communication services. The user might need to
take mitigation measures, such as relocating or re-orienting
the equipment.
Harmonic emissions
Class A
IEC 61000-3-2
Conforms
Voltage fluctuations/
flicker emissions
Conform
IEC 61000-3-3
85
3 Vrms (0.15 MHz - 80 MHz)
Conducted RF
6 Vrms in ISM bands
IEC 61000-4-6
80% AM at 1 kHz
3 V/m 80 MHz - 2.7 GHz
Radiated RF
IEC 61000-4-3
80% AM at 1 kHz
9 V/m
710 MHz, 745 MHz, 780 MHz,
5.240 MHz, 5.550 MHz, 5.785 MHz
Proximity fields
27 V/m
from RF wireless
communications
385 MHz
equipment
IEC 61000-4-3
28 V/m
450 MHz, 810 MHz, 870 MHz, 930 MHz,
1.720 MHz, 1.845 MHz, 1.970 MHz,
2.450 MHz
NOTE
U
is the mains voltage in AC before applying test level.
T
Edition) and by
th
en
en
Portable
RF
communications
equipment
(including
peripherals
such as antenna cables and external
en
antennas) should be used no closer
than 30 cm (12 inches) to any part
of the product, including cables.
Otherwise,
degradation
of
the
performance of this equipment could
result.
en
EnDrive - EMC Tables | 39
84
Electromagnetic immunity compliance
IEC 60601-1-2
Immunity test
Compliance level
test level
Electrostatic
± 8 kV contact
discharge (ESD)
± 15 kV air
IEC 61000-4-2
± 1 kV for I/O lines 100 kHz repetition
Electrostatic fast
transient/burst
± 2 kV for power supply lines 100 kHz
IEC 61000-4-4
repetition frequency
± 1 kV line-to-line
Surge
(± 2 kV line-to ground: case not
IEC 61000-4-5
applicable to electrically insulated
Class II ME Equipment)
0% U
for 0.5 cycles at 0°, 45°, 90°,
T
135°, 180°, 225°, 270° and 315°
Voltage dips
IEC 61000-4-11
0% U
for 1 cycle and 70% U
T
T
25/30 cycles. Single phase at 0°
Voltage
interruptions
0% U
for 250/300 cycles
T
IEC 61000-4-11
Power frequency
magnetic field
30 A/m (50 Hz or 60 Hz)
IEC 61000-4-8
86
Recommended minimum separation distances between portable and mobile RF communications
equipment and the device as per IEC 60601-1-2 Ed. 3
The device is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the device can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the device as recommended below, according to the maximum output power of
the communication equipment.
Separation distance according to frequency of the transmitter (m)
Rated maximum
output power of
From 150 kHz to
transmitter (W)
80 MHz
d = 1.2 √P
0.01
0.12
0.1
0.38
1
1.2
10
3.8
100
12
For transmitter rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTES
• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
è
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%.
The medical device is suitable
for use in professional healthcare
establishment environments.
The medical device is suitable
for use in professional healthcare
establishment environments. If the
for
user of the device requires continued
operation
during
power
mains
interruptions, it is recommended
that the device is powered from an
uninterruptible power supply or a
battery.
The medical device is suitable
for use in professional healthcare
establishment environments.
From 80 MHz to
From 800 MHz to
800 MHz
2 GHz
d = 1.2 √P
d = 1.2 √P
0.12
0.23
0.38
0.73
1.2
2.3
3.8
7.3
12
23
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