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Regulatory recommendation
4.1 Conformity
This device has been designed and manufactured by a company with a certifi ed quality system.
It complies with the requirements of the European Directive 93/42/EEC 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 and electrostatic
discharges
Although this product complies with the EMC standards, it is possible under very special circumstances
that it may interfere with other devices or be interfered by other devices or by an unfavourable
electromagnetic environment.
This medical electrical equipment needs special precautions regarding EMC and needs to be installed
according to EMC information.
Image transfers from the camera to a monitor may be susceptible to electromagnetic disturbances.
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.).
4.3 Materio vigilance
As for any medical system, this device is subject to the provisions pertaining to materio vigilance; any
serious malfunction must be promptly communicated to the competent authorities and the manufacturer
with the greatest possible precision.
For the address of the manufacturer please see the last page of manual.
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 properly, you will help prevent potential negative consequences for
the 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
the local dealer to whom you purchased the product from and who will tell you how to proceed.
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