Electromagnetic Compatibility (Emc); Electromagnetic Emissions - Medela Invia Motion Instrucciones De Uso

Electromagnetic compatibility (EMC)

Invia Motion is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 and IEC 60601-1-2:2014
4th Edition according clause 7 and 8.9.
Electromagnetic compatibility (EMC, IEC 60601-1-2:2007 3rd Edition and IEC 60601-1-2:2014 4th Edition,
Table 1)

Electromagnetic Emissions

The Invia Motion NPWT system is intended for use in the electromagnetic environment specified below.
The customer or the user of Invia Motion NPWT system should assure that they are used in such
environment.
Emission Tests
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
WARNING
The Invia Motion NPWT system should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the Invia Motion NPWT system should be observed to verify
normal operation in the configuration in which it will be used.
WARNING
Invia Motion is a medical device that requires special safety precautions and must be installed and
placed in operation in accordance with the attached EMC information.
WARNING
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 Invia
Motion pump.
WARNING
EMC
HF (high-frequency) surgical equipment, radio networks or the like can influence the operation of
the device and may not be operated in combination with the Invia Motion pump.
WARNING
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the Invia Motion.
Otherwise, degradation of the performance of this equipment could result.
Compliance Electromagnetic environment – guidance
Group 1 The Invia Motion NPWT system uses RF energy only for their
internal function. Therefore, its RF emissions are very low and
are not likely to cause any interference with nearby electronic
equipment.
Class B The Invia Motion NPWT system is suitable for use in all
establishments, including domestic establishments and those
directly connected to the public low-voltage power supply
Class A
network that supplies buildings used for domestic purposes.
Complies
31