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Mobile 2 RPW User Manual
7. Technical Specifications of the Control Device
7.3 CONFORMITY WITH DIRECTIVES
This medical product bears the CE mark in accordance with the Medical Device Directive (MDD) 93/42/EEC.
7.4 CONFORMITY WITH STANDARDS
According to EN 60601-1
Type of protection against electric shocks:
Protection class 1
Application unit of Type B*
*Application units include the surfaces of the R-SW and V-ACTOR handpieces, including the interchangeable transmitters.
EMC GUIDELINES AND MANUFACTURER’S DECLARATION
Guidelines and manufacturer’s declaration –
emitted electromagnetic interference
The device model is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Emitted interference measurements
Compliance
Electromagnetic environment –
guidelines
HF emissions according to CISPR 11
Group 1
The device uses HF energy only for
its internal functioning. Therfore, its
HF emissions are very low and are
not likely to cause any interference in
nearby electronic equipment. I
HF emissions according to CISPR 11
Class B
The device is suitable for use in all
facilities, including those in
residential areas and those that
are directly connected to a public
electricity supply network that also
powers devices which are used for
residential purposes.
Harmonic emissions according to IEC
61000-3-2
Class A
Voltage fluctuations / flicker emissions
according to IEC 61000-3-3
Complies
