Technical Documentation - Medela BiliBed Manual De Instrucciones

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Technical Documentation

Technical Description
Electromagnetic Compatibility (EMC, IEC 60601-1-2)
IEC 60601-1-2, Table 201
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
Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations /
Complies
flicker emissions
IEC 60000-3-3
IEC 60601-1-2, Table 202
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.
IEC 60601
Immunity Tests
test level
Electrostatic
± 6 kV contact
Discharge (ESD)
± 8 kV air
IEC 61000-4-2
± 2 kV for power supply
Electrical fast
lines
transient/burst
± 1 kV for input/output
IEC 61000-4-4
lines
Surge
± 1 kV differential mode
± 2 kV common mode
IEC 61000-4-5
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
Voltage dips, short
40 % UT
interruptions and
(60 % dip in UT)
voltage variations
for 5 cycles
70 % UT
on power supply
(30 % dip in UT)
input lines IEC
for 25 cycles
61000-4-11
<5 % UT
(>95 % dip in UT)
for 5 sec
Power frequency
(50/60 Hz)
3 A/m
magnetic field
IEC 61000-4-8
NOTE U
is the a.c. mains voltage prior to application of the test level.
T
Electromagnetic environment-guidance
The BiliBed uses RF energy only for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in nearby electronic equipment.
The BiliBed is suitable for use in all establishments, including domestic establishments
and those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
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.
Compliance level
± 6 kV contact
± 8 kV air
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 1 kV differential mode
± 2 kV common mode
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
3 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.
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