Ameda Elite Instructions page 9

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 cabled sold by the MANUFACTURER of the Ameda Elite
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.
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
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
± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s)
± 2 kV line(s) to earth ± 2 kV line(s) to earth
<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
Breast Pump as replacement parts for internal components,
may result in increased EMISSIONS or decreased IMMUNITY
of the Ameda Elite Breast Pump.
Warning: The Ameda Elite Breast Pump should not be used
adjacent to or stacked with other equipment. If adjacent
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
any interference in nearby electronic equipment.
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
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 Elite 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 Elite 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.