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Table N.5 – Guide and manufacturer declaration – electromagnetic immunity
Electromagnetic immunity
The MAJESTIC II device it is intended for use in an electromagnetic environment specified below. The client
or the user of the MAJESTIC II bed should ensure that it is used in said environment
Immunity Test
Test according
Rule IEC 60601
Conformity Level
Electromagnetic immunity -
guide
Electrostatic
discharge (DES)
IEC 61000-4-2
±6 kV by contact
±8 kV by air
±6 kV by contact
±8 kV by air
The floor should be made of wood,
concrete or ceramic tile. If the floors
are covered with synthetic material,
the relative humidity should be at
least 30%
Transients / Rapid
bursts
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input /
output lines
± 2 kV for power
supply lines
±1 kV for input /
output lines
The quality of the power network
should be that of a typical commercial
environment or that of a hospital.
Shock waves
IEC 61000-4-5
±1 kV line to line
±2 kV line to line
±1 kV línea a línea
±2 kV línea a tierra
The quality of the power network
should be that of a typical commercial
environment or that of a hospital.
Voltage drops,
interruptions and
voltage variations in
the input lines of
the power supply.
IEC 61000-4-11
<5% U
t
( >95% dip in U
t
)
for 0,5 cycles
40% U
t
(60% dip en U
t
)
for 5 cycles
70% U
t
(30% dip en U
t
)
for 25 cycles
>5% U
t
(>95% dip en U
t
)
for 5 seconds
<5% U
t
( >95% dip in U
t
)
for 0,5 cycles
40% U
t
(60% dip en U
t
)
For 5 cycles
70% U
t
(30% dip en U
t
)
For 25 cycles
>5% U
t
(>95% dip en U
t
)
For 5 seconds
The quality of the power network
should be that of a typical commercial
environment or that of a hospital.
If
the user of the MAJESTIC II requires
continuous operation during power
interruptions, it is recommended that
the MAJESTIC II be powered by an
uninterruptible power supply or a
battery
Magnetic field at
network frequency
(50/60 Hz)
IEC 61000-4-8
3 A/m
3 A/m
The quality of the power network
should be that of a typical commercial
environment or that of a hospital
Note:
U
t
is the alternating current supply voltage before the application of the test level