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14.
Compatibilité électromagnétique / Electromagnetic compatibility /
Elektromagnetische Verträglichkeit/ Compatibilidad electromagnética /
Compatibilità elettromagnetica / Elektromagnetische compatibiliteit /
Kompatybilność elektromagnetyczna
Electro medical devices require special precautions against EMC and must be installed and set to operate in accordance with the
EMC information provided in this manual.
WARNING: Avoid using this unit near or stacked onto other equipment as this may cause a malfunction. If this is necessary, this
appliance and the other appliances should be monitored for normal operation.
WARNING: Use of accessories, transducers and cables other than those specified or supplied by the manufacturer of this device may
cause an increase in electromagnetic emissions or a decrease in the immunity of this device and cause improper operation.
WARNING: Portable RF communication devices (including peripherals such as antenna cables and external antennas) should not be
used closer than 12 inches (30 cm) to any part of the AE device, including cables specified by the manufacturer.
Otherwise, performance may be impaired.
WARNING: If the device malfunctions due to electromagnetic disturbances, the performance of the device may be impaired and
result in delayed patient care.
Wireless communication devices such as wireless home networking devices, mobile phones, cordless phones and their bases,
walkie-talkies can affect the device, and it is recommended to keep them at a distance of at least 0.5 m from the device.
Guidance and manufacturer's declaration – electromagnetic emissions
Emissions test
Compliance
RF emissions - CISPR 11
Group 1
RF emissions - CISPR 11
Class B
Harmonic emissions - IEC 61000-3-2
Class A
Voltage fluctuations / flicker emissions - IEC 61000-3-3
Complies
Guidance and manufacturer's declaration – electromagnetic immunity
Immunity test
IEC 60601
test level
Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV
± 15 kV
Electrical fast transient / burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV
± 1 kV
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
0% U
T
; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0% U
T
; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0% U
T
; 1 cycle
AND 70% U
T
; 25/30 cycles
Single phase : at 0°
0% U
T
; 1 cycle
AND 70% U
T
; 25/30 cycles
Single phase : at 0°
Voltage interruptions
IEC 61000-4-11
0% U
T
: 250/300 cycles
0% U
T
: 250/300 cycles
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2,7 GHz
10 V/m
80 MHz to 2,7 GHz
385 MHz at 27 V/m
450 MHz at 28 V/m
710, 745, 780 MHz at 9 V/m
810, 870, 930 MHz at 28 V/m
1720, 1845, 1970 MHz at 28 V/m
2450 MHz à 28 V/m
5240, 5500, 5785 MHz à 9 V/m
385 MHz at 27 V/m
450 MHz at 28 V/m
710, 745, 780 MHz at 9 V/m
810, 870, 930 MHz at 28 V/m
1720, 1845, 1970 MHz at 28 V/m
2450 MHz à 28 V/m
5240, 5500, 5785 MHz à 9 V/m
Conducted RF
IEC 61000-4-6
3V
0,15 MHz – 80 MHz
6V in ISM bands and amateur radio bands
between 0.15 MHz and 80 MHz
80% MA at 1kHz
3V
0,15 MHz – 80 MHz
6V in ISM bands and amateur radio bands
between 0.15 MHz and 80 MHz
80% MA at 1kHz
