Notice Required By Law; Medical Device Vigilance - Comeg SOPRO 184 Manual De Usuario

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Notice required by law

4.1 Compliance
This product was designed and manufactured by a company with a certifi ed quality system.
It fulfi ls the requirements of European Directive 93/42/EEC, relating to medical devices.
Consequently, in particular it complies with electrical safety standards (IEC) and ad hoc ElectroMagnetic
Compatibility (EMC) standards.
4.2 Electromagnetic interferences and electrostatic discharge
Although this product does comply with EMC standards, it is possible under very special circumstances
that it may disrupt other devices, or that it may itself be disrupted by other devices or an unfavourable
electromagnetic environment.
In order to avoid these situations, the following are recommended:
• Ensuring the quality of the electrical network (and particularly the earthing of all the devices and
carriages)
• Keeping the device away from electromagnetic sources (for example the compressor, motor, transformer,
HF generator, etc.).

4.3 Medical device vigilance

As is the case with any medical device, this device is subject to the provisions relating to medical device
vigilance; any serious malfunction must therefore be reported to the competent authorities and to the
manufacturer as soon as possible, and as accurately as possible.
For the manufacturer's contact details, refer to the last page of the manual.
4.4 End of lifecycle
This device bears the recycling symbol, in accordance with European Directive 2002/96/EEC
concerning Waste Electrical and Electronic Equipment (WEEE).
By disposing properly of this device, you will contribute to preventing any harmful consequences for the
environment and human health.
The symbol on the device or on the documentation accompanying it indicates that this product may
not be treated like household waste under any circumstances. Consequently, it must be disposed of at a
waste collection center responsible for recycling electrical and electronic equipment waste.
For disposal purposes, comply with the standards relating to disposing of waste in force in the country
where the device is installed. To obtain more details about the topic of treatment, recovery and recycling
of this device, please contact the competent offi ce in your borough, the waste collection company, or
contact your retailer directly.
011546C 11