Technical Documentation; Electromagnetic Emissions; Electromagnetic Immunity - Medela BiliBed Mode D'emploi

Technical Documentation

Technical Description
Electromagnetic Compatibility (EMC, IEC 60601-1-2)
IEC 60601-1-2, Table 1

Electromagnetic Emissions

The BiliBed is intended for use in the electromagnetic environment specified below. The customer or the user of the
®
BiliBed should assure that it is used in such environment.
Emission Tests
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 60000-3-3
IEC 60601-1-2, Table 2

Electromagnetic Immunity

The BiliBed is intended for use in the electromagnetic environment specified below. The customer or the user of the BiliBed
should assure that it is used in such environment.
Immunity Tests
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE U is the a.c. mains voltage prior to application of the test level.
T
60
Compliance
Electromagnetic environment-guidance
The BiliBed uses RF energy only for its internal function. Therefore, its RF emissions are
Group 1
very low and are not likely to cause any interference in nearby electronic equipment.
Class B
The BiliBed is suitable for use in all establishments, including domestic establishments
Class A
and those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Complies
Warning: The BiliBed should not be used adjacent to or stacked with other equip-
ment. If adjacent or stacked use is necessary, the BiliBed should be observed to
verify normal operation in the configuration in which it will be used.
IEC 60601
test level Compliance level
± 6 kV contact ± 6 kV contact
± 8 kV air
± 8 kV air
± 2 kV for power supply ± 2 kV for power supply
lines lines
± 1 kV for input/output ± 1 kV for input/output
lines lines
± 1 kV differential mode
± 1 kV differential mode
± 2 kV common mode ± 2 kV common mode
<5 % UT
<5 % UT
(>95 % dip in UT)
(>95 % dip in UT)
for 0.5 cycle
for 0.5 cycle
40 % UT
40 % UT
(60 % dip in UT)
(60 % dip in UT)
for 5 cycles
for 5 cycles
70 % UT
70 % UT
(30 % dip in UT)
(30 % dip in UT)
for 25 cycles
for 25 cycles
<5 % UT
<5 % UT
(>95 % dip in UT)
(>95 % dip in UT)
for 5 sec
for 5 sec
3 A/m >30 A/m
Electromagnetic environment-guidance
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30 %.
Mains power quality should be that of a typical com-
mercial or hospital environment.
Mains power quality should be that of a typical com-
mercial or hospital environment.
Mains power quality should be that of a typical com-
mercial or hospital environment. If the user of the
BiliBed requires continued operation during power
mains interruptions, it is recommended that the BiliBed
be powered from am uninterruptible power supply or a
battery.
Power frequency magnetic fields should be at levels of a
typical commercial or hospital environment.