Electromagnetic Compatibility (Emc) - Derungs D med IRIS LED 10 Montage- Und Gebrauchsanweisung

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ELECTROMAGNETIC COMPATIBILITY (EMC)

The medical device is intended for operation in an electromagnetic environment such as the one specified below.
The user must ensure that it is operated in such an environment.
Emissions
High-frequency emissions
(CISPR 11)
High-frequency emissions
(CISPR 11)
Emissions from harmonics
(IEC 61000-3-2)
Emissions from voltage
fluctuations/flicker (IEC 61000-3-3)
The medical device is intended for operation in an electromagnetic environment such as the one specified below.
The user must ensure that it is operated in such an environment.
Interference resistance to
Electrostatic discharge (ESD)
(IEC 61000-4-2)
Fast transients/electrical
disturbance variables/bursts
(IEC 61000-4-4)
Surge voltages/surges
(IEC 61000-4-5)
Magnetic field in the power
supply frequency (50/60 Hz)
(IEC 61000-4-8)
Voltage dips and short
interruptions to the power
voltage
(IEC 61000-4-11)
Radiated HF disturbance
variable (IEC 61000-4-3)
Conducted HF disturbance
values (IEC 61000-4-6)
d = recommended safe distance [m], P = Rated power of the sender [ W ]. Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with:
Recommended safe distances from portable and mobile HF communications equipment
Rated Power of the sender [ W ]
0.01
0.1
1
10
50
100
Electromagnetic interference guidelines
In accordance Electromagnetic environment
Group 1 The medical device uses HF energy exclusively for its internal function.
This means that its HF emissions are very low, and it is unlikely that adjacent
electronic devices will receive any interference.
Class B The medical device is intended for use in all facilities, including residential
buildings and facilities that are directly connected (without a transformer) to the
same low voltage network as residential buildings.
Class C
Compliance
Electromagnetic interference resistance guidelines
IEC 60601-1-2
testing level
Contact discharge: ± 6 kV
Air discharge: ± 8 kV
Power supply cables:
± 2 kV
Longer input and output
cables: ± 1 kV
±1 kV phase-to-phase
voltage
±2 kV phase-to-earth
voltage
3 A/m
Cut >95 %, 0.5 periods
Cut 60 %, 5 periods
Cut 30 %, 25 periods
Cut >95 %, 5 seconds
3 V/m
80 MHz - 2.5 GHz
3 V
rms-value
150 kHz - 80 MHz:
150 kHz - 800 MHz
Conformity level of Electromagnetic environment
the medical device
± 6 kV Floors made of timber, concrete or ceramics tiles
± 15 kV are preferred. Where synthetic floor covering is
used, the relative humidity should be at least 30%.
± 2 kV The quality of the mains power supply should
match that of a typical business or hospital
Not applicable environment.
±2 kV The quality of the mains power supply should
match that of a typical business or hospital
±1 kV environment.
100 A/m In proximity of this medical device, do not operate
devices with unusually strong network-frequency
magnetic fields (transformer stations etc.).
Cut >95 %, 0.5 periods The supply voltage quality should be that of a
Cut 60 %, 5 periods typical business or hospital environment. If the user
Cut 30 %, 25 periods requires continued function during any interruption
Cut >95 %, 5 seconds of the energy supply system, we recommend that
the medical device be powered by an uninterrupted
power supply or a battery.
10 V/m Recommended minimum distance of portable and
mobile radio devices of PEIRP radiated power to the
medical device, including its cables:
10 V Recommended minimum distance of portable and
rms-value
mobile radio devices of PEIRP radiated power to the
medical device, including its cables:
80 MHz – 800 MHz:
800 MHz - 2.5 GHz:
0.035 m (0.11 ft)
0.11 m (0.36 ft)
0.35 m (1.15 ft)
1.11 m (3.64 ft)
2.47 m (8.10 ft)
3.5 m (11.48 ft)
√
d = 0.35 P
√
d = 0.35 P
√
d = 0.7 P
800 MHz - 2.5 GHz
0.07 m (0.23 ft)
0.22 m (0.72 ft)
0.7 m (2.30 ft)
2.21 m (7.25 ft)
4.95 m (16.24 ft)
7 m (22.97 ft)
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ENG