The OPUS 2 speech processor and the FineTuner are in compliance with EU
Directive 90/385/EEC (Active Implantable Medical Devices/AIMD).
CE mark applied in 2006
The OPUS 2 speech processor and the FineTuner (RF link) comprise “Class 2” radio
equipment under the R&TTE directive.
Hereby MED-EL declares that the OPUS 2 speech processor and the FineTuner
(RF link) are in compliance with the essential requirements and other relevant
provisions of EU Directive 1999/5/EC (Radio Equipment and Telecommunications
Terminal Equipment/R&TTE). The Declaration of Conformity can be obtainted
directly from MED-EL Worldwide Headquarters (for address see Chapter 11,
Appendices).
Caution, consult accompanying documents (manual)
Type BF
(IEC 60601-1 / EN 60601-1)
Non-ionizing radiation (FineTuner)
Applicable in Bulgaria only:
The OPUS 2 speech processor and the FineTuner (RF link) are in accordance with
the Ordinance for essential requirements and conformity assessment of radio
equipment and telecommunications terminal equipment.
Fragile; handle with care
Relative humidity; moisture content
Temperature limit
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