Ameda Elite Manuale di istruzioni - Pagina 7
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regarding EMC and needs to be installed and put into service
according to the EMC provided in these Instructions for use.
Warning: The use of ACCESSORIES, transducers and cables
other than those specified, with the exception of transducers
The Ameda Elite 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 Elite Breast Pump is intended for use in the
electromagnetic environment specified below.
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test
MMUNITY
Electrostatic discharge
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
field IEC 61000-4-8
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is the a.c. mains voltage prior to application of the test level.
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8
E N G L I S H
Guidance and manufacturer's declaration – electromagnetic emissions
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/± 1 kV for
supply lines/± 1 kV for
input/output lines
input/output lines
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dip in
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dip in
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3 A/m
3 A/m
Breast Pump as replacement parts for internal components,
of the Ameda Elite Breast Pump.
Warning: The Ameda Elite Breast Pump should not be used
or stacked use is necessary, the Ameda Elite 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 Elite Breast Pump
should assure that it is used in such an environment.
Compliance
Electromagnetic environment – guidance
Group 1
The Ameda Elite Breast Pump uses RF energy
only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause
Class B
The Ameda Elite Breast Pump is suitable for
use in all establishments, including domestic
Class A
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 Elite 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
commercial or hospital environment.
commercial or hospital environment.
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dip in
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commercial or hospital environment. If the user
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continued operation during power mains
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interruptions, it is recommended that the Ameda
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Elite Breast Pump be powered from an
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uninterruptible power supply.
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levels characteristic of a typical location in a
typical commercial or hospital environment.