52
53
Emissions Test
Compliance Electromagnetic
environment
guidance
RF emissions CISPR 11
Group 2
Class B
The medical
device uses RF
energy only for its
internal function.
Therefore, its RF
emission are very
low and are not
likely to cause any
interferences in
nearby electronic
equipment.
Harmonic emissions
Complies
Voltage fluctuations /
flicker emissions
Complies
Compliance with emission and immunity standards
Emission standards
EN 60601–1-2
IEC 60601–1-2
23.
Information and explanation of
symbols
xxxx
With the CE symbol, Sonova AG confirms that
this product – including accessories – meets the
requirements of the Medical Devices Regulation (EU)
2017/745 as well as the Radio Equipment Directive
2014/53/EU. The numbers after the CE symbol
correspond to the code of certified institutions that were
consulted under the above-mentioned regulation and
directive.
This symbol indicates that the products described in
these user instructions adhere to the requirements for
an applied part of Type B of EN 60601-1. The surface of
the hearing aid is specified as applied part of Type B.
Indicates the medical device manufacturer, as
defined in Medical Devices Regulation (EU) 2017/745.
Indicates the date when the medical device was
manufactured.
Indicates the Authorized representative in the
European Community. The EC REP is also the importer
to the European Union.
This symbol indicates that it is important for the user to
read and take into account the relevant information in
these user guides.