Medela Swing Mode D'emploi page 17

7. EMC/Technical Description (cont.)
Guidance and manufacturer's declaration – electromagnetic emissions
This breast pump is intended for use in the electromagnetic environment specified
below. The customer or the user of the breast pump should assure that it is used in
such an environment.
Electromagnetic Compatibility (EMC, IEC 60601-1-2:2014 4th Ed.)
Emission tests Compliance Electromagnetic environment – guidance
RF Emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic
emissions IEC
Class A
61000-3-2
Voltage
fluctuations /
flicker Not Applicable
emissions
IEC 61000-3-3
Warning
Warning – This Swing breast pump should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary, this breast pump
should be observed to verify normal operation in the configuration in which it will
be used.
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The 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.
The 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.
Guidance and manufacturer's declaration – electromagnetic immunity
This breast pump is intended for use in the electromagnetic environment specified
below. The customer or the user of the breast pump should assure that it is used
in such an environment. The Sonata Breast Pump has no essential performance
but was tested for immunity to electromagnetic disturbances and passed using the
following criteria:
1. No visible change in the operation of the breast pump.
2. The breast pump changes settings but returns automatically to previous settings.
3. The breast pump changes settings but can return to previous settings by
intervention of the user.
IEC 60601
Immunity test
test level
Electrostatic ± 8 kV contact
discharge ( ESD ) ± 2 kV, ± 4 kV, ± 8.kV,
IEC 61000-4-2 ± 15 kV air
Electrical fast ± 2 kV
transient/burst 100 kHz repetition
IEC 61000-4-4 frequency
Surge ± 0,5 kV , ± 1 kV
IEC 61000-4-5 Line-to-line
Questions? Visit www.medela.com or call us at 1-800-435-8316.
Electromagnetic
Compliance
environment
level
– guidance
Floors should be
wood, concrete or
ceramic tile. If floors
± 8 kV contact
are covered with
± 2 kV, ± 4 kV, ±
synthetic material,
8.kV, ± 15 kV air
the relative humidity
should be at least
30%.
Mains power quality
± 2 kV
should be that of a
100 kHz repetition
typical commercial or
frequency
hospital environment.
Mains power quality
± 0,5 kV , ± 1 kV should be that of a
Line-to-line typical commercial or
hospital environment.
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