Dentmate LEDEX WL-090, Instructions For Use Manual

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11. EMC Declaration Of Conformity
Important information regarding Electro Magnetic Compatibility (EMC)
with the increased number of electronic devices such as PC’s and mobile (cellular)
telephones,medical devices in use may be susceptible to electromagnetic
interference from other devices. Electromagnetic interference may result in
incorrect operation of the medical device and create a potentially unsafe situation.
Medical devices should not interfere with other devices, too.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility)
with the aim to prevent unsafe product situations, the EN60601-1-2:2007
standard has been implemented. This standard defines the levels of immunity
to electromagnetic interferences as well as maximum levels of electromagnetic
emissions for medical devices.
This medical device manufactured by DENTMATE conforms to thisEN60601-
1-2:2007standard for both immunity and emissions. Nevertheless, special
precautions are needed to be observed:
• Do not use mobile (cellular) telephones and other devices which generate
strong electrical or electromagnetic fields near the medical device. This may
result in incorrect operation of the unit and create a potentially unsafe situation.
Keep a minimum distance of 7 m. Verify correct operation of the device in case
the distance is shorter.
Further documentation in accordance with EN60601-1-2:2007 is available within
this manual referring to section “Manufacturer’s Declaration”.
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