Electromagnetic Emissions - Medela Dominant Flex Mode D'emploi

I Technical documentation
WARNINGS
Do not use other accessories than those specified or sold by the manufacturer as replace-
ment parts for internal components as it may result in increased emissions or decreased
immunity of the Dominant Flex pump�
HF (high-frequency) surgical equipment, radio networks or the like can influence the opera-
tion of the device and may not be operated in combination with the Dominant Flex pump�
EMC (Electromagnetic Compatibility)
Dominant Flex has been EMC-tested in conformity with the requirements of IEC 60601-1-2:2007
and IEC 60601-1-2:2014 4th Edition according to clause 7 and 8�9 and can be used in the
vicinity of other EMC-tested devices that fulfill the requirements of the relevant IEC 60601-1-2
standard� Dominant Flex is a medical device that requires special safety precautions and must
be installed and placed in operation in accordance with the following EMC information�
Essential Performance
Medela has determined that the Dominant Flex suction pump does not have any functions,
the failure of which to work properly, could impact the safety of the system� As such, there
is no essential performance as defined in the IEC 60601-1-2 standard� Nevertheless, the
Dominant Flex was tested in accordance with IEC 60601-1-2 ensuring that the pump could
maintain the correct vacuum during testing�
Electromagnetic Compatibility (EMC, IEC 60601-1-2, 3rd Edition and IEC60601-1-2 4th Edition,
Table 1)

Electromagnetic Emissions

Dominant Flex is intended for use in the electromagnetic environment specified below�
The customer or the user of Dominant Flex should assure that it is used in such
environment�
Emission Tests
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctutions /
flicker emissions
IEC 60000-3-3
WARNINGS
Dominant Flex should not be used adjacent to or stacked with other equipment� If
adjacent or stacked use is necessary, Dominant Flex should be observed to verify
normal operation in the configuration in which it will be used�
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Technical documentation
Compliance Electromagnetic environment – guidance
Group 1 Dominant Flex uses RF energy only for its inter-
nal function� Therefore, its RF emissions are very
low and are not likely to cause any interference
with nearby electronic equipment�
Class B Dominant Flex is suitable for use in all esta-
blishments, including domestic establishments
and those directly connected to the public
Class A
low-voltage power supply network that supplies
buildings used for domestic purposes�
Complies