Regulatory Recommendations; Conformity; Electromagnetic Interference & Electrostatic Discharges; Materio Vigilance - SOPRO COMEG 210 Manuel D'utilisation

REGULATORY RECOMMENDATION

4.1 CONFORMITY

This device has been designed and manufactured by a company with a certified quality system.
It complies with the requirements of the European Directive 93/42/CEE related to medical devices.
As a result, it complies in particular with the ad hoc electric safety (IEC) and Electromagnetic Compatibility
(EMC) standards.
4.2 ELECTROMAGNETIC INTERFERENCE & ELECTROSTATIC DISCHARGES
Although this product complies with the EMC standards, it is possible under very special circumstances that it
may disturb other devices or even be disturbed in turn by other devices or by an unfavourable EM environment.
To prevent such situations, it is recommended
• To take care of the quality of the electric network (and particularly the grounding system of all the devices
and carriages) ;
• To keep the device away from Electromagnetic sources (e.g., compressor, motor, transformer, HF generator, etc.).
This device can be disturbed by a strong electrostatic discharge.
In such a case, turn off and then turn on the device and follow again the start instructions.
If the phenomenon repeats, the grounding connections and system should be checked.
4.3

MATERIO VIGILANCE

Like for any medical system, this device is subject to the provisions pertaining to materio vigilance; any serious
dysfunction must therefore be promptly notified to the competent authorities and the manufacturer with the
greatest possible precision.
4.4

END OF LIFE

This appliance is marked according to the European Directive 2002/96/EEC on Waste Electrical and Electronic
Equipment (WEEE).
By ensuring this product is disposed of correctly, you will help prevent potential negative consequences for
environment and human health, which could otherwise be caused by inappropriate waste handling of this product.
The symbol on the product, or on the documents accompanying the product, indicates that this appliance
may not be treated as household waste. Instead it shall be handed over to the applicable collection point for
recycling of electrical and electronic equipment.
Disposal must be carried out in accordance with local environmental regulations for waste disposal.
For more detailed information about treatment, recovery and recycling of this product, please contact your
local city office your household waste disposal service or the dealer to whom you purchased the product from.
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