Ameda Elite Manual De Instrucciones página 8

EN
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
Guidance and manufacturer's declaration – electromagnetic emissions
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
Guidance and manufacturer's declaration – electromagnetic immunity
The Ameda Elite Breast Pump is intended for use in the
electromagnetic environment specified below.
I MMUNITY test IEC 60601 test level
Electrostatic discharge ± 6 kV contact
(ESD) IEC 61000-4-2 ± 8 kV air
Electrical fast ± 2 kV for power
transient/burst IEC supply lines/± 1 kV for
61000-4-4 input/output lines
Surge IEC 61000-4-5 ± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Voltage dips, short <5% U
interruptions and U
voltage variations on 40% U
power supply input U
lines IEC 61000-4-11 70% U
U
<5% U
U
3 A/m
field IEC 61000-4-8
U T is the a.c. mains voltage prior to application of the test level.
8
E N G L I S H
Compliance
Group 1
Class B
Class A
Complies
Compliance level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines/± 1 kV for
input/output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
T (>95% dip in <5% U
T ) for 0,5 cycle U T ) for 0,5 cycle
T (60% dip in 40% U
T ) for 5 cycles U T ) for 5 cycles
T (30% dip in 70% U
T ) for 25 cycles U T ) for 25 cycles
T (>95% dip in <5% U
T ) for 5 s U T ) for 5 s
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.
Electromagnetic environment – guidance
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
The Ameda Elite Breast Pump 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.
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
relative humidity should be at least 30%.
commercial or hospital environment.
commercial or hospital environment.
T (>95% dip in
commercial or hospital environment. If the user
T (60% dip in
continued operation during power mains
T (30% dip in interruptions, it is recommended that the Ameda
Elite Breast Pump be powered from an
T (>95% dip in uninterruptible power supply.
levels characteristic of a typical location in a
typical commercial or hospital environment.