Electromagnetic Compatibility (Emc) - Derungs Dmed Halux N50-1 P SX Mode D'emploi

ENG
12.

ELECTROMAGNETIC COMPATIBILITY (EMC)

Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility. This device can be affected
by other electrical devices.
This device was tested for electromagnetic compatibility using accessories from the list of accessories. Other accessories may only be used if
they do not compromise the electromagnetic compatibility. The use of non-compliant accessories may result in increased electromagnetic
emissions or decreased electromagnetic immunity of the device.
WARNING
Risk due to insuffcient separation distance
If mobile high-frequency communication equipment is used too close to this device,malfunctions that put the patient at risk may occur.
Maintain a separation distance of at least 0.3 m (1.0 ft).
Electromagnetic environment
This device may only be used in environments specified in the "Intended use" section of the instructions for use.
The device is intended for use in an electromagnetic environment as specified below.
Emissions
RF emissions
EN 55011 (CISPR 11)
Radiated: 30 MHz bis 1 GHz
Conducted: 150 kHz bis 30 MHz
Harmonic emissions
(IEC 61000-3-2)
Voltage fluctuations / flicker
emissions
(IEC 61000-3-3)
Immunity against
Electrostatic discharge (ESD)
(IEC 61000-4-2)
Rapid transient
electrical disturbances:
Bursts (IEC 61000-4-4)
Impulse voltage/surges
(IEC 61000-4-5)
Voltage dips and interruptions
in the power supply
(IEC 61000-4-11)
Magnetic field at the supply
frequency
(IEC 61000-4-8)
Emitted RF disturbance
(IEC 61000-4-3)
Conducted RF interference
(IEC 61000-4-6)
20
Compliance
Class B, Group 1
Class A
Compliant
Test level and required electromagnetic
environment
Contact discharge: ± 8 kV
Air discharge: ± 15 kV
Power cables: ± 2 kV
Longer signal input lines/output lines: ± 1 kV
Voltage:
External conductor- external conductor: ± 1 kV
External conductor- protective ground
conductor: ± 2 kV
30 % to 100 %, 10 ms to 5 s, different phase
angles
50Hz and 60Hz: 30 A/m
80 MHz up to 2,7 GHz: 10 V/m
150 kHz up to 80 MHz: 3 V
rms
ISM bands and amateur radio bands: 6 V
Electromagnetic environment
The medical device is intended for use in all facilities,
including residential buildings and facilities connected
directly (without a transformer) to the same low-
voltage network as residential buildings.
Electromagnetic environment
Floors are preferably made of wood, concrete or
ceramic tiles. In the case of synthetic floor covering,
the relative humidity should be at least 30%.
The quality of the supply voltage should correspond
to that of a typical business or hospital environment.
Devices with strong line-frequency magnetic fields
(transformer stations, etc.) should not be operated in
the vicinity of the medical device.
Faults are possible in the area around devices which
are marked with the following pictogram:
rms