Regulatory Advice; Medical Device Vigilance - SOPRO COMEG SYMBIOZ Cam Manual De Usuario

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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 (CEM) ad hoc.
4.2 ELECTROMAGNETIC INTERFERENCES AND ELECTROSTATIC
DISCHARGE
Although this product complies with CEM standards, it may in very special circumstances in-
terfere with other devices, or itself be the object of interference from other apparatuses or an
unfavourable electromagnetic environment.
Image transfers from the camera to a monitor may be susceptible to electromagnetic distur-
bances 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 appara-
tuses and medical carts.
• Keep the apparatus away from electromagnetic sources (e.g. compressors, motors, transfor-
mers, 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 LIFE CYCLE
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 indi-
cates that this product cannot under any circumstances be treated as household waste. It must
therefore be delivered to a waste collection centre 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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