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The device has undergone EMC (Electromagnetic Compatibility) verifications for medical devices as per EN60601-1-2.
The device needs special precautions about the EMC and must therefore be installed and commissioned following the
EMC information included in this manual.
Any portable and mobile radiocommunications equipment (including also transmission peripherals such as cables and
antennas) could influence the functioning of the device. Therefore, they should be placed at a distance of at least 30 cm.
Failure to observe this indication could result in a malfunctioning.
Furthermore, interferences could occur in proximity of any equipment marked with the following symbol
The use of cables different from the provided ones could cause an increase of the EMISSIONS or a decrease of the
IMMUNITY of the device.
The device should not be used near other electrical or electronic equipment. If necessary, verifying that the device
functions correctly. In case of faults or transient noises, not only the device stops working but it also clearly indicates that.
The device can be used in any building, including also residential buildings and those directly connected to the public
low-voltage power supply network which supplies buildings intended for residential use.
Based on the verifications carried out, the following further warnings are provided:
The device is suited for the use in a specific electromagnetic environment. The buyer or the end-user of the device should make sure
that it is used in an electromagnetic environment having the following characteristics:
Radiated or conducted RF
Harmonic emissions
Voltage fluctuations and flicker emission
Electrical Fast Transient (EFT)
Voltage dips, short interruptions and voltage variations
Power-frequency magnetic field (50/60 Hz)
M000016 REV6
WARNINGS ON ELECTROMAGNETIC INTERFERENCES
Emissions test
CISPR 11
IEC 61000-3-2
IEC 61000-3-3
Immunity test
ESD
EN61000-4-2
EN61000-4-4
Surge
EN61000-4-5
EN61000-4-11
EN61000-4-8
Radiated RF
EN61000-4-3
Conducted RF
EN61000-4-6
Test level (and conformity test)
± 1kV differential mode voltage
± 2kV common mode voltage
31/31
Conformity
Group 1
Class B
Class A
Conform
EN60601-1-2
(maximum values)
± 8kV contact discharge
± 15kV air discharge
± 2kV power line
± 1kV I/O line
0% U
during 0.5 cycle
n
70% U
during 25 cycles
n
0% U
during 5 seconds
n
30A/m
3V/m
80MHz 2.7GHz
3V
150kHz 80MHz
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