Technical Documentation; Electromagnetic Emissions - Medela Basic Instrucciones De Uso

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 Basic pump.
EMC
Basic is 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 may not be operated in combination with the
system. Basic is a medical device that requires special safety precautions and must be
installed and placed in operation in accordance with the attached EMC information. Portable
and mobile RF communication devices (mobile telephones) can affect Basic.
Essential Performance
Medela has determined that the Basic 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 essen-
tial performance as defined in the IEC 60601-1-2 standard. However, the Basic was tested
per 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

Basic is intended for use in the electromagnetic environment specified below. The cus-
tomer or the user of Basic 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
Basic should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, Basic 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 Basic uses RF energy only for its internal func-
tion. Therefore, its RF emissions are very low
and are not likely to cause any interference with
nearby electronic equipment.
Class B Basic is suitable for use in all establishments,
including domestic establishments and those
directly connected to the public low-voltage
Class A
power supply network that supplies buildings
used for domestic purposes.
Complies