Standards And Regulations - ACteon Sopix 2 Manuel D'utilisation

STANDARDS AND REGULATIONS

4.1. COMPLIANCE WITH STANDARDS AND REGULATIONS
Compliance with European Community directives
The Sopix² system design, manufacturing and distribution comply with the European directive 93/42/EEC
requirements, relative to medical devices.
SOPRO certifies this device went through audit tests and was declared complying with the restrictions imposed
by the safety standards of electromedical devices (IEC 60601-1) and of electromagnetic compatibility (IEC
60601-1-2).
Medical device vigilance
As any medical device, this device is subjected to the medical device vigilance dispositions; any serious
dysfunction should then be the subject of a description to the competent authorities and to the manufacturer
as soon as possible and as precisely as possible.
Scrapping the system
This device bears the recycling symbol according to the European directive 2002/96/EC about electric and
electronic equipment waste (DEEE or WEEE).
By correctly disposing of this device, you will avoid damaging the environment and human health.
The symbol present on the device or on the accompanying documentation indicates that this product cannot
be in any case treated as household waste. Therefore, it should be given to a waste collection centre that
handles electric and electronic equipment recycling.
Standards in force in the installation country must be respected relative to waste disposal. To have more details
about this device treatment, recuperation and recycling, please contact your dental device distributor (or
failing that, the group ACTEON site) regarding the indicated procedure.
NOTE:
To avoid any environment contamination risk likely to cause mild or serious injuries, be sure to dispose of
the device and its accessories as special waste.
E N G L I S H
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