Comeg SOPRO 218, User Manual

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ENGLISH
4 Regulatory
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.