Regulatory Advice; Medical Device Vigilance; End Of Lifecycle - Comeg SYMBIOZ Cam+ Manuel Utilisateur

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Regulatory advice

4.1 Compliance
This product was designed and manufactured by a company with a certified quality system.
It meets the requirements of European directive 93/42/CEE, on medical devices.
Consequently, it particularly meets the standards of electrical safety (IEC) and electromagnetic
compatibility (EMC) ad hoc.
4.2 Electromagnetic interferences and electrostatic
discharge
Although this product complies with EMC standards, it may in very special circumstances interfere with
other devices, or itself be the object of interference from other apparatuses or an unfavorable electro-
magnetic environment.
This medical electrical equipment needs special precautions regarding EMC and needs to be installed
according to EMC information.
Mobile RF communications equipment can affect this medical electrical equipment.
Image transfers from the camera to a monitor may be susceptible to electromagnetic disturbances and
electric system disturbances.
In order to avoid these situations, it is advisable to:
• Ensure of the quality of the electric power system (especially the grounding of all apparatuses and
medical carts).
• Keep the apparatus away from electromagnetic sources (e.g. compressors, motors, transformers,
HF generators, etc.).

4.3 Medical device vigilance

Like any medical device, this apparatus is subject to the stipulations governing medical device vigilance,
and therefore any serious malfunction must be reported to the competent authorities and to the
manufacturer as quickly and as accurately as possible. For manufacturer contact details, refer to the
last page of the manual.

4.4 End of lifecycle

This apparatus carries the recycling symbol in compliance with European directive 2002/96 CEE on Waste
Electrical and Electronic Equipment (DEEE or WEEE). By correctly disposing of this apparatus you are helping
to prevent harmful effects on the environment and on human health.
The symbol displayed on the apparatus and on the accompanying documentation indicates that
this product cannot under any circumstances be treated as household waste. It must therefore be
delivered to a waste collection center for the recycling of electrical and electronic equipment.
In disposing of it, please comply with the waste elimination norms in effect in the country where
it is installed.
For further details on the treatment, recovery and recycling of this apparatus, kindly contact your
nearest retailer who will advise you on the procedure to follow.
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