Zimmer Soleo Sono, Instructions For Use Manual, Page: 46 / 52

Manufacturer's EMC Declaration
19
Page 37
Medical electrical equipment such as the Soleo Sono 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 Sono may only be operated with the original parts specified in the list of parts and accessories included
within the scope of delivery. 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 Sono device is intended for use in the electromagnetic environment specified below. The customer or the
user of the Soleo Sono 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 Sono device must emit
electromagnetic energy in order to perform its
intended function. Nearby electronic
equipment may be affected.
RF emissions in accordance with CISPR 11 Class B The Soleo Sono 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.