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”.
12. Manufacturer’s Declaration
The LEDEX
TM
WL-070 is intended for use in the electromagnetic environment
specified below. The customer or the user of the LEDEX
TM
WL-070 should assure
that it is used in such an environment.
Electromagnetic Emissions: (IEC60601-1-2)
Emission Test Compliance Electromagnetic Environment
RF emission
CISPR 11
Group 1
The LEDEX
TM
WL-070 uses RF energy
only for internal functions. Therefore, this
RF emission is extremely weak and there
is little chance of it creating any kind
of interference whatsoever with nearby
electronic equipment.
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Class B
The LEDEX
TM
WL-070 is suitable for use
in all establishments, including domestic
establishments and those directly
connected to the public low voltage
power supply network that supplies
buildings used for domestic purposes.
Voltage fluctuations/
flicker
IEC 61000-3-3
Complies
EN
15
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