Medela Dominant Flex Instrucciones De Uso página 386

22 Technical documentation
WARNINGS
Do not use other accessories than those specified or sold by the manufacturer as
replacement parts for internal components as it may result in increased emissions or
decreased immunity of 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 can be used in the vicinity of other EMC-tested devices that fulfill the requirements of the
relevant IEC 60601-1-2 standard� Untested HF (high-frequency) sources, radio networks or
the like can influence the operation of the device and must not be operated in combination with
the system� 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�
Portable and mobile RF communication devices (mobile telephones) can affect Dominant Flex�
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, 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