Led Information Concerning The Radiation Emitted; Installation And Putting Into Initial Operation; Important; Safety Requirements During Installation - Kulzer Translux Wave Instrucciones De Uso

4.2.5

LED information concerning the radiation emitted

WARNING
Photobiological safety of lamps and lamp systems IEC 62471. According to the Standard IEC 62471, the device
results in risk class 2 (moderate risk) concerning a retinal risk from blue light or thermal retinal risk. The above
warning indications are applied to the device package.
5

Installation and putting into initial operation

GB
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
- 10 -
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 defi ned 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 specifi cations 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 fl ammable liquids as they could
damage the plastic casings of the device.
The plug of the Switching Power Supply (Direct Plug-In), model PSAC05R-050L6, 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 suffi cient free space around it. The medical equipment shall not be positioned
to make diffi cult to operate on the disconnection device (so on the plug of the Switching Power Supply).
Never short circuit the end elements of the battery with any metal object as it could cause a risk of burns,
fi re and explosion.
Risk Group 2
CAUTION. Possibly hazardous optical
radiation emitted from this product.
Do not stare at operating lamp. May
be harmful to the eye
Product tested against IEC62471