Idiomas disponibles
Idiomas disponibles
22. ELECTROMAGNETIC COMPATIBILITY DECLARATION
The device satisfies the EMC requirements of the international standard IEC 60601-1-2. The
requirements are satisfied under the conditions described in the table below. The device is an electrical
medical product and is subject to special precautionary measures with regard to EMC which must be
published in the instructions for use. Portable and mobile HF communications equipment can affect
the device. Use of the unit in conjunction with non-approved accessories can affect the device negatively
and alter the electromagnetic compatibility. The device should not be used directly adjacent to or
between other electrical equipment.
Table 1
Guidance and declaration of manufacturer-electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Emissions test
Radiated emission CISPR 11
Conducted emission CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
Table 2
Guidance and declaration of manufacturer-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user
of the device should assure that it is used in such an environm- ent.
IMMUNITY test
IEC 60601 test level
± 8 kV
Electrostatic
discharge (ESD) IEC
contact
± 2 kV,± 4 kV,
61000-4-2
± 8 kV,
± 15 kV air
± 2 kV ,
Electrostatic
transient/burst IEC
100kHz, for AC power
61000-4-4
port
± 0.5kV, ± 1kV
Surge
IEC 61000-4-5
(differenziale )
Voltage dips, short
0 % UT; 0,5 cycle
interrupti- ons and
At 0°, 45°, 90°, 135°,
voltage variations
180°, 225° , 270°
on p- ower supply
and 315° 0 % UT; 1
in- put lines
cycle and 70 % UT;
IEC 61000-4-11
25/30 cycles
Single phase: at 0°
0 % UT;250/300
cycle
Power frequency
30 A/m; 50Hz or
(50/60 Hz)
60Hz
magnetic field
IEC 61000-4-8
Compliance
Electromagnetic environment -guidance
Group 1,
The device uses RF energy only for its internal fun-
class B.
ction. Therefore, its emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
Group 1,
The device is suitable for use in all establishments,
class B.
including domestic establishments and those directly
connected to the public low-voltage power supply
Class A
network that supplies buildings used for domestic
Complies
purposes.
Compliance level
± 8 kV
contact
± 2 kV,± 4 kV,
± 8 kV,
± 15 kV air
± 2 kV ,
100kHz, for AC
power port
± 0.5kV, ± 1kV
(differenziale )
0 % UT; 0,5 cycle
At 0°, 45°, 90°,
135°, 180°, 225° ,
270° and 315° 0 %
UT; 1 cycle and 70
% UT; 25/30 cycles
Single phase: at 0°
0 % UT;250/300
cycle
30 A/m; 50Hz or
60Hz
ENGLISH
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 %.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Power frequency magnetic fields should
be at levels charactertic of a typical loca-
tion in a typical comme- rcial or hospital
environment.
23
