Heraeus Kulzer Translux Power Blue, Инструкция по эксплуатации

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4.2.5 LED information concerning the radiation emitted
This device uses high-luminosity LEDs, Class 2M (IEC 60825-1).
LED Radiation.
Do not stare into the beam or view directly with optical
instruments.
• Class 2M LED Product.
• IEC 60825-1:1993 + A1:1997 + A2:2001.
•
Max. power: < 5.00 mW.
•
Dominant wavelength:
Min. 440 nm – Max. 465 nm.
WARNING
Diverging beams
Do not
observe the emission of light from the LED using optical instruments such as monocles, magnifying
glasses or microscopes from a distance of less than 100 mm as this could cause a risk of damage to your eyes.
Collimated beams
Do not
observe the emission of light from the LED using optical instruments designed for use at a distance,
such as telescopes or binoculars, since this could cause a risk of damage to your eyes.
In the event of the LED control circuit failure, the LED radiation emission cannot exceed the value in the normal
use condition of the medical equipment.
Labels are provided on the packaging of the device, as indicated in the figure here above.
5 Installation and putting into initial operation
The following sections of this paragraph contain the information and instructions which must be followed to ensure
successful and faultless operation of the device. Before operating the Translux Wave follow the instructions in the
sequence described below.
The medical system is in compliance with the safety standards only if it is installed by following the instructions
described here below.
The device must be installed in a suitable place that is handy for its use. Place the charging unit on a sturdy,
dry, flat and horizontal surface.
IMPORTANT
The hand piece is intended for use within the patient environment whereas the charger unit and the
Switching Power Supply adapter are not intended for use within the patient environment.
NOTE
The patient environment is defined as an area 1.5 m from the patient (as per IEC 60601-1, third edition
and IEC 60601-1-1).
WARNING
Always inspect the unit and its components for any damage before installation.
If damage is apparent, do not proceed with the installation of the device.
The operator must not come simultaneously into contact with the elements outside the patient environment
(charger units and switching power supply adapter) and the patient.
Do not connect other external components to the medical system.
5.1 Safety requirements during Installation
WARNING
The electrical installation of the premises where the device is installed and used must comply with existing
legislation and the safety specifications relevant to power systems.
Install the device in a place where it will be protected from blows and from accidental splashes of water
or other liquids. Do not expose the device to direct sunlight, UV light.
Do not
install the device on top or close to sources of heat. When installing, make sure that there is adequate
air circulating around the device. Do not install the device close to solvents or flammable liquids as they could
damage the plastic casings of the device.
The plug of the Switching Power Supply (Direct Plug-In), model PSAC05R-050, is considered the mean of
isolating of the medical equipment from supply mains. When the plug is connected, the power supply adapter
must be easily accessible. Leave sufficient free space around it. The medical equipment shall not be positioned
to make difficult to operate on the disconnection device (so on the plug of the Switching Power Supply).
LED RADIATION
DO NOT STARE INTO THE BEAM OR VIEW DIRECTLY
WITH OPTICAL INSTRUMENTS
CLASS 2M LED PRODUCT
IEC 60825-1:1993 + A1:1997 + A2:2001
MAX POWER < 5,00 mW
Dominant wavelenght Min. 440nm – Max. 465nm