Standards And Regulations - SOPRO COMEG 284 Manual De Utilización

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STANDARDS AND REGULATIONS

4.1 CONFORMITY
This product was designed and manufactured by a company which has a certified quality system.
It complies with the requirements of European Directive 93/42/EEC on medical devices.
It therefore conforms particularly to the standards of electrical safety (IEC) and electromagnetic
compatibility (EMC) ad hoc.
4.2 ELECTROMAGNETIC INTERFERENCE AND ELECTROSTATIC DISCHARGE
Although this product conforms to EMC standards, under very particular circumstances it may interfere
with other devices, be subject to interference from other devices or an adverse electromagnetic
environment.
To avoid these situations it is advisable:
• to ensure the quality of the electrical network (especially the earthing of all appliances and trolleys),
• to distance the device from electromagnetic sources (e.g. compressor, motor, transformer, HF generator, etc.).
4.3 MEDICAL DEVICE VIGILANCE
Like any medical device, this product is subject to medical device vigilance provisions; any serious
malfunction should therefore be the subject of a report to the competent authorities and to the
manufacturer as soon as possible and as precisely as possible.
Manufacturer's contact details: please refer to the last page of the manual.
4.4 DEVICE END OF LIFE
This device bears the recycling symbol in compliance with the European Directive 2002/96/EC on waste
electrical and electronic equipment (WEEE).
By correctly scrapping this device, you will help to prevent any harmful consequences for 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 centre that handles recycling of electrical and electronic equipment.
When scrapping this device, 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 nearest
dealer regarding the recommended procedure.
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