End Of Life; Regulatory Requirements - Acteon SOPRO 617 Betriebsanleitung

E N G L I S H
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REGULATORY REQUIREMENTS

4.1. COMPLIANCE WITH STANDARDS AND REGULATIONS
This product was designed and manufactured by a company having an authorized quality system. It meets the
requirements of the European directive 93/42/EEC, relative to medical devices. Therefore, it particularly meets
electrical safety and electromagnetic compatibility standards (IEC) (CEM).
4.2. ELECTROMAGNETIC INTERFERENCE AND ELECTROSTATIC DISCHARGES
Electromagnetic compatibility (CEM) is the ability of electronic device elements to correctly interact in an
electronic environment. Although this dental camera system was designed according to this compatibility and
complies with the electromagnetic interference thresholds established by the regulatory agency, there is no
guarantee about the interference likely to occur on a particular installation.
If the device generates interference with radio communication services (which can be determined by switching
it off and on), the user is recommended to try to correct this phenomenon by taking whole or part of the
following measures:
• Change the receiving antenna orientation.
• Reposition the product according to the receiver.
• Take away the computer from the receiver.
SOPRO 617 dental camera system is designed and tested to be used in a home environment, class B Group 1,
according to CISPR11 standard.
4.3. 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.

4.4. END OF LIFE

This device bears the recycling symbol according to the European directive 2002/96/EC about electric and
electronic equipment waste (DEEE or WEEE). Properly disposing of this device will contribute to avoiding any
damage done to the environment or human health.
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