Electromagnetic Compatibility (Emc) - Derungs Dmed HX LED 7 Instructions D'utilisation

EN
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ELECTROMAGNETIC COMPATIBILITY (EMC)

The medical device is intended for operation in an electromagnetic environment as defined below. The user is to make sure that it
will be operated in this kind of environment.
Emissions
HF emissions
(CISPR 11)
HF emissions
(CISPR 11)
Emissions of
harmonics
(IEC 61000-3-2)
Emissions of
voltage
fluctuations/flicker
(IEC 61000-3-3)
The medical device is intended for operation in an electromagnetic environment as defined below. The user is to make sure that it
will be operated in this kind of environment.
Immunity against
Electrostatic discharge
(ESD)
(IEC 61000-4-2)
Electrical fast transients/
Bursts (IEC 61000-4-4)
Surge voltages
(IEC 61000-4-5)
Supply frequency
magnetic field
(50/60 Hz)
(IEC 61000-4-8)
Voltage dips and
short-time interruptions
of the supply voltage
(IEC 61000-4-11)
Radiated HF
disturbance
(IEC 61000-4-3)
Conducted HF
disturbances
(IEC 61000-4-6)
1) For PEIRP, use the maximum "equivalent isotropically radiated power" of the surrounding radio equipment in watt. High-frequency
emissions may also be generated in the surrounding of appliances beating the symbol
field intensity of stationary, portable or mobile radio transmitters shout not exceed 3 V/m in the 150 kHz to 2,5 GHz frequency range and
1 V/m above 2,5 GHz.
Recommended safety distances to portable and mobile HF communication equipment
The safety distances mentioned below correspond to the specifications in IEC 60601-1-2.
Max. P (W)
EIRP
0,03
0,10
0,17
0,20
0,25
0,41
0,82
1,00
1,64
3,28
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Guidelines- Electromagnetic interference emissions
Compliance according to
Group 1
Class B
Class A
Compliant
Guidelines- Electromagnetic immunity
IEC 60601-1-2 test level
Contact discharge: ± 6 kV
Air discharge: ± 8 kV
Network lines: ± 2 kV
Long input and output lines:
± 1 kV
Common-mode voltage: ±2 kV
Differential mode voltage: ±1 kV
3 A/m
Dip >95 %, 0.5 periods
Dip 60 %, 5 periods
Dip 30 %, 25 periods
Dip >95 %, 5 seconds
80 MHz to 2,5 GHz: 3 V/m
150 kHz to 80 MHz: 3 V
150 kHz to 2.5 GHz
0,32 m (1,05 ft)
0,58 m (1,90 ft)
0,76 m (2,49 ft)
0,82 m (2,69 ft)
0,92 m (3,02 ft)
1,18 m (3,87 ft)
1,67 m (5,48 ft)
1,84 m (6,04 ft)
2,36 m (7,74 ft)
3,33 m (10,93 ft)
Electromagnetic environment
The medical device uses HF energy exclusively for its internal functions.
Therefore its HF emissions are very low, and they are unlikely to affect
neighbouring electronic appliances.
The medical device is intended for use in all establishments, including
residential buildings and establishments that are connected directly (without
transformer) at the same low voltage network as residential buildings.
Compliance level of Electromagnetic environment
the medical device
± 6 kV Preferred floors: wood, concrete or ceramic
± 8 kV tiles. In case of synthetic floor coverings, the
relative air humidity should be at least 30%.
± 2 kV The quality of the supply voltage should
Not applicable correspond to that of a typical business or
hospital environment.
±2 kV The quality of the supply voltage should
±1 kV correspond to that of a typical business or
hospital environment.
3 A/m There should be no appliances with
exceptionally strong supply-frequency magnetic
fields (transformer stations, etc.) operating in the
close environment of the medical device.
Dip >95 %, 0.5 periods The quality of the supply voltage should
Dip 60 %, 5 periods correspond to that of a typical business or
Dip 30 %, 25 periods hospital environment. If the user needs a
Dip >95 %, 5 seconds continued operation in case of a breakdown of
the energy supply, it is recommended to power
the medical device with an uninterruptible power
supply or a battery.
3 V/m Recommended minimum distance from portable
and mobile radio equipment with transmission
power PEIRP to the medical device, including its
connection lines: (1,84 m x PEIRP)
3 V Recommended minimum distance from portable
and mobile radio equipment with transmission
power PEIRP to the medical device, including its
connection lines:
All other frequencies
0,96 m (3,15 ft)
1,75 m (5,74 ft)
2,28 m (7,48 ft)
2,47 m (8,10 ft)
2,76 m (9,06 ft)
3,53 m (11,58 ft)
5,00 m (16,40 ft)
5,52 m (18,11 ft)
7,07 m (23,20 ft)
10,00 m (32,81 ft)
(1,84 m x PEIRP)
. At the location of the medical device, the
Examples
e. g. WLAN 5250 / 5775 (Europe)
e. g. WLAN 2440 (Europe)
e. g. Bluetooth, RFID 2,5 GHz
e. g. WLAN 5250 (not in Europe)
e. g. UMTS mobile phones
e. g. DECT wireless phones
e. g. RFID 13,56 MHz
e. g. WLAN 5600 (not in Europe)
e. g. GSM 1800 / GSM 1900
e. g. GSM 900 mobile phones, RFID 868
MHz
1)
1)