ENGLISH
SOPIX SERIES • User’s manual
8
STANDARDS AND REGULATIONS
4.1. COMPLIANCE WITH STANDARDS AND REGULATIONS
Compliance with European Community directives
The SOPIX series system design, manufacturing and distribution comply with the requirements of the European Medical Devices
Directive 93/42/EEC.
SOPRO certifi es that this device underwent control tests and was declared as complying with the restrictions imposed by the safety
standards for medical electrical equipment (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2).
Medical device vigilance
Like any medical device, SOPIX series systems are subject to medical device vigilance provisions; any serious malfunction should
then be the subject of a report to the competent authorities and to the manufacturer as soon as possible and as precisely as possible.
Scrapping the system
SOPIX series systems bear the recycling symbol according to the European directive 2002/96/EC concerning waste electrical and
electronic equipment (WEEE).
By correctly disposing of this device, you will avoid damaging the environment and human health.
The symbol
appearing on the device or on the accompanying documentation indicates that this product cannot under any
circumstances be treated as household waste. Therefore, it should be given to a waste collection center that handles electrical and
electronic equipment recycling. Standards in force in the country of installation relating to waste disposal must be observed. For
more details about the treatment, recovery and recycling of this device, please contact your dental device distributor (or failing
that, the ACTEON group site) regarding the recommended procedure.
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