Ameda Finesse Mode D'emploi page 25

EMC Information
MEDICAL ELECTRICAL EQUIPMENT needs special precautions
regarding EMC and needs to be installed and put into service
according to the EMC provided in these Instructions for use.
Portable and mobile RF communications equipment can
affect MEDICAL ELECTRICAL EQUIPMENT.
Warning: The use of ACCESSORIES, transducers and
cables other than those specified, with the exception of
transducers and cables sold by the MANUFACTURER of
Guidance and manufacturer's declaration – electromagnetic emissions
The Ameda Finesse Breast Pump is intended for use in the
electromagnetic environment specified below.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/flicker emissions
IEC 61000-3-3
The Ameda Finesse Breast Pump is intended for use in the
electromagnetic environment specified below.
I test
mmunity
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
Guidance and manufacturer's declaration – electromagnetic immunity
IEC 60601 test level Compliance level
± 6 kV contact
± 6 kV contact
± 8 kV air ± 8 kV air
± 2 kV for power ± 2 kV for power
supply lines supply lines
± 0.5 kV, ±1 kV line(s) ± 0.5 kV, ±1 kV line(s)
to line(s) to line(s)
<5% U (>95% dip in <5% U
t
U ) for 0,5 cycle U
t
40% U (60% dip in 40% U
t
U ) for 5 cycles U
t
70% U (30% dip in 70% U
t
U ) for 25 cycles U
t
<5% U (>95% dip in <5% U
t
U ) for 5 s U
t
3 A/m 3 A/m
the Ameda Finesse Breast Pump as replacement parts for
internal components, may result in increased EMISSIONS or
decreased IMMUNITY of the Ameda Finesse Breast Pump.
Warning: The Ameda Finesse Breast Pump should not be
used adjacent to or stacked with other equipment and that
if adjacent or stacked use is necessary, the Ameda Finesse
Breast Pump should be observed to verify normal operation
in the configuration in which it will be used.
The customer or the user of the Ameda Finesse Breast Pump
should assure that it is used in such an environment.
Compliance Electromagnetic environment – guidance
The Ameda Finesse Breast Pump uses RF energy
Group 1
only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
Class B
The Ameda Finesse Breast Pump is suitable for
Class A use in all establishments, including domestic
establishments and those directly connected to
Complies
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
The customer or the user of the Ameda Finesse Breast Pump
should assure that it is used in such an environment.
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
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
(>95% dip in Mains power quality should be that of a typical
t
) for 0,5 cycle commercial or hospital environment. If the user
t
(60% dip in of the Ameda Finesse Breast Pump requires
t
) for 5 cycles continued operation during power mains
t
(30% dip in interruptions, it is recommended that the Ameda
t
) for 25 cycles Finesse Breast Pump be powered from an
t
(>95% dip in uninterruptible power supply.
t
) for 5 s
t
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
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