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Table 8: Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
The Entre system is intended for use in the electromagnetic environment specified
below . The customer or the user of the Entre should assure that it is used in such an
environment .
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic
Environment –
Guidance
Electrostatic
discharge (ESD) IEC
61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood,
concrete or ceramic
tile . If floors are covered
in synthetic material,
the relative humidity
should be at least 30% .
Electrical fast
transient/burst
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
Mains power quality
should be that of a
typical commercial or
hospital environment .
Surge
IEC 61000-4-5
± 1 kV line to line
± 2 kV line to earth
± 1 kV line to line
± 2 kV line to earth
Voltage dips, short
interruptions and
voltage variations on
power adapter lines
IEC 61000-4-11
<5 % U
T
(>95 % dip in U
T
)
for 0 .5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5 sec
<5 % U
T
(>95 % dip in U
T
)
for 0 .5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5 sec
Mains power quality
should be that of a
typical commercial or
hospital environment .
If the user of the
Entre system requires
continued operation
during power mains
interruptions, it is
recommended that
the device be powered
from an uninterruptible
power adapter .
Power frequency
(50/60 Hz) Magnetic
field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment .
NOTE U
T
is the a .c . mains voltage prior to application of the test level .