Manufacturer's EMC Declaration
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Page 79
Medical electrical equipment such as the Soleo SonoStim/Soleo Galva are subject to special precautions with regard to EMC
(electromagnetic compatibility) and must be installed and commissioned in accordance with the EMC information contained
in the user manual or the accompanying documents.
Portable and mobile RF communications equipment (e.g. mobile phones) can affect electrical medical equipment.
Soleo SonoStim / Soleo Galva may only be operated with the original parts specified in the list of the delivery and
accessories. The operation of the device with other parts may result in increased emissions or in the device's decreased
interference immunity.
Guidelines and Manufacturer's Declaration - Electromagnetic Emissions
The Soleo SonoStim / Soleo Galva device is designed for operation in the electromagnetic environment specified
below. The customer or the user of the Soleo SonoStim/Soleo Galva must ensure that it is operated in such an
environment.
Emissions measurements
Compliance
Electromagnetic environment - guidelines
RF emissions in accordance with CISPR 11 Group 2
The Soleo SonoStim/Soleo Galva device must
emit electromagnetic energy in order to
ensure its intended function. Nearby electronic
equipment may be affected.
RF emissions in accordance with CISPR 11 Class B
The Soleo SonoStim/Soneo Galva device is
suitable for use in all establishments, including
domestic establishments and those directly
connected to the public supply network that
also supplies buildings used for domestic
purposes.
Emissions of harmonics in accordance with
IEC 61000-3-2
Category A
Emissions of voltage fluctuations / flickers
in accordance with IEC 61000-3-3
Compliant
Table 201 according to EN 60601-1-2: 2006-10
The device must not be used in direct proximity to or stacked directly on top of another similar device. If operation near to or
stacked on top of another device is unavoidable, the device should be monitored to verify its proper operation within this
setup.
