ENGLISH
mm
Millimeters (Length unit).
A
Ampere (Electric Current unit).
V
Volt (Electric Voltage unit).
Pa
Pascal (Atmospheric Pressure unit).
°C
Degrees Centigrade (Temperature unit).
kg
Kilograms (Weight unit).
PRODUCT DESCRIPTION
Classification of medical devices pursuant to Directive 93/42/EEC (Annex IX)
Duration: Temporary
Invasive devices: Non‐invasive
Active medical device: Active
Due to the above characteristics the device falls under class I (in accordance with Rule 1)
Classification in accordance with general regulations (standard CEI EN 60601)
According to the type of protection against electrical hazards: Class I equipment
According to the type of protection against ingress of water: Ordinary equipment
According to the degree of safety in use in the presence of a flammable anaesthetic mixture with
air or oxygen or nitrous oxide: Device not suitable for use with what is described above
The dental whitening lamp is for use in the beauty and dental sector.
Dental whitening is the only and sole purpose.
The lamp emits an intense light radiation.
The operator who uses the device must have the necessary qualifications and experience.
The operator must have received the necessary training in its correct use and must know
the position of all the controls:
for positioning the lamp
for switching the lamp on and off and the time setting functions.
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