43
16.2 Guidelines and manufacturer’s declaration – electromagnetic interference immunity
Electromagnetic
interference immunity
tests
IEC60601- TestLevel Compliance Level Electromagnetic
Environment - Guidelines
Electrostatic discharge
(ESD) in accordance
with IEC61000-4-2
± 8kV contact
discharge
± 2kV, ± 4kV,
± 8kV, ± 15kV
air discharge
as test level Floors should be made of wood or
concrete or covered with ceramic
tiles� If the floor has a synthetic
material covering, the relative
humidity must be at least 30%�
Rapid transient
electrical
interference/ bursts
in accordance with
IEC61000-4-4
± 2kV for power
supply cables
± 1kV for input and
output cables
± 2kV for power
supply cables
(power supply)
not applicable
The quality of the supply voltage
should be that of a typical business
or hospital environment, e�g�
according to EN50160�
Surge voltages
(surges) in accordance
with IEC61000-4-5
± 1kV normal mode
voltage
± 2kV common mode
voltage
± 1kV normal mode
voltage
± 2kV common mode
voltage,
not applicable
The quality of the supply voltage
should be that of a typical business
or hospital environment,
e�g� according to EN50160�
Magnetic field at
supply frequency
(50 / 60 Hz) in
accordance with
IEC61000-4-8
30A/m
50 or 60Hz
30A/m
50 and 60Hz
Magnetic fields at mains frequency
should correspond to the typical
values found in a business or
hospital environment�
Voltage drops, brief
interruptions and
fluctuations in the
supply voltage in
accordance with
IEC61000-4-11
0 % U
T
(100 % drop
in U
T
) for 0�5cycles;
0°, 45°, 90°, 135°,
180°, 225°, 270°, 315°�
0 % U
T
(100 % drop in
U
T
) for 1 cycle�
70 % U
T
(30 % drop in
U
T
) for 25/30cycles
0 % U
T
(100 % drop in
U
T
) for 5s
as test value The quality of the supply voltage
should be that of a typical business
or hospital environment�
If the user of the VivanoTecPro
negative pressure unit requires
continuous functioning even in the
event of interruptions to the power
supply, it is recommended to supply
the VivanoTecPro negative pressure
unit through an uninterruptible
power supply or a battery�
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