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ENGLISH
4 Regulations
This product was designed and manufactured by a company which has a certified quality
system in place. It complies with the requirements of EU directive 93/42/EEC on medical
products. It therefore also complies with the electrical safety standards (IEC) and the applicable
standards for electromagnetic compatibility (EMC).
4.1 Conformity
Despite compliance with the EMC standards, it may occur under certain circumstances that the
device interferes with other devices or is subjected to interferences by other devices and/or in an
electromagnetic environment.
In order to avoid such incidents we recommend the following:
• Ensure the quality of the electric supply (especially grounding of all devices and tables/trolleys)
• Keep the device away from electromagnetic sources (such as compressors, motors, transformers,
HF generators, etc...).
4.2 Electromagnetic interference and electrostatic discharge
Like all medical products this device is subject to the Medical Devices Vigilance regulations.
Therefore any serious malfunction must be immediately notified to the relevant authorities
and the manufacturer as detailed as possible.
For manufacturer contact details see last page of manual
4.3 Medical devices vigilance
This device is marked with the recycling symbol pursuant to EU directive 2002/96/EC on waste
electrical and electronic equipment (WEEE).
By correctly disposing of this device you avoid potential damage to the environment or human
health.
The symbol
on the device or on the documents supplied means that the device must not
be treated as household waste. It must be deposited at a designated collection facility which is
dedicated to the recycling of waste electrical and electronic equipment.
In addition, all local regulations regarding disposal applicable in the country in which you work
must be observed.
For more information on treatment, recovery and recycling of the device please contact your
nearest distributor who will instruct you on the procedure to be followed.
4.4 Disposal
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