Electromagnetic Compatibility (Emc) - Derungs Dmed halux LED 20-3 P Gebrauchsanweisung

12 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.
Immunity to
Electrostatic discharge (ESD)
(IEC 61000-4-2)
Electrical fast
transients/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 sags and short
interruptions to the supply
voltage
(IEC 61000-4-11)
Radiated HF disturbances
(IEC 61000-4-3)
Conducted HF disturbances
(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 for all frequencies.
Interference may occur in the vicinity of equipment marked with:
Recommended safe distances from portable and mobile HF communications equipment
Rated Power of the transmitter [ W ]
0.01
0.1
1
10
50
100
Electromagnetic emission guidelines
Compliance 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 experience 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
Compliant
Electromagnetic interference immunity 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-ground
voltage
3 A/m
Sag >95 %, 0.5 cycles
Sag 60 %, 5 cycles
Sag 30 %, 25 cycles
Sag >95 %, 5 seconds
3 V/m
80 MHz - 2.5 GHz
3 V
rms-value
150 kHz - 80 MHz:
150 kHz - 800 MHz
Compliance 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 supply voltage should match
that of a typical business or hospital environment.
Not applicable
±1 kV The quality of the supply voltage should match
that of a typical business or hospital environment.
n/a
100 A/m In proximity of this medical device, do not operate
devices with unusually strong network-frequency
magnetic fields (transformer stations etc.).
Sag >95 %, 0.5 cycles The quality of the supply voltage should match
Sag 60 %, 5 cycles that of a typical business or hospital environment.
Sag 30 %, 25 cycles If the user requires continued function during any
Sag >95 %, 5 seconds interruption 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 radiated power PEIRP to
the medical device, including its cables:
10 V Recommended minimum distance of portable and
rms-value
mobile radio devices of radiated power PEIRP 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)
ENG
d = 0.35
√
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)
15
√
P