claros pico user manual V 2.1 page 8 of 34
2
Warning notices
2.1
Warning notices – personal hazard
If the following instructions are ignored or not followed correctly, this may result in endangerment of the patient,
operator or support staff.
1. By law, the device may only be sold to or on behalf of a dentist.
2. The energy emitted by the laser light exceeds the tolerance threshold of the eye and can therefore lead to
irreversible damage to the eye. The prescribed safety glasses must be worn by all persons in the treatment room in
order to prevent eye damage. The pilot laser (target beam) is automatically switched on when an application
program is started. Do not look into the beam.
3. Safety glasses with filter level 5 or higher at 808 nm bearing the CE marking in accordance with EN207:1998 must
be worn; these are available from elexxion AG with the name "claros protect". The separate instructions for use for
the laser safety glasses must be observed when using laser safety glasses.
4. The laser danger zone (referred to as the 'treatment room' in the following) is the entire area located within the
range of the laser beam. Warning! As reflections from instruments and equipment introduced into the beam path are
possible, the laser danger zone is only delimited by obstacles around the laser system that are not transparent with
regard to laser radiation (e.g. walls, ceiling, floor, closed doors) . An NOHD value (distance from which the laser can
be observed safely) is not given due to the high mobility of the laser aperture. The entire room in which the laser is
operated must be treated as the laser protection area.
5. The room in which the device is operated must be equipped in accordance with the BGV B2 accident prevention
regulations. The electrical installation must comply with DIN VDE 0100 Part 710. This is the responsibility of the
operator or a laser safety officer appointed by the operator. The BGV B2 accident prevention regulations can be
obtained from elexxion AG upon request.
6. The operator of the laser system must ensure that the treatment room is clearly marked and that nobody enters
the treatment room without safety glasses (see item 2) while the laser is being used.
7. Use is only permitted in rooms designed for medical purposes and which meet the above requirements. Use
anywhere else is not allowed.
8. Only accessories specified by elexxion AG may be used. A list of all accessories can be found in Section 6 of these
instructions for use. In case of doubt, please consult your medical product consultant.
9. Use of the operating equipment in any way other than that described here may result in dangerous irradiation.
10. The device may not be used in explosive atmospheres, irrespective of how these are created.
11. People must not look into the laser beam directly or through optical devices or instruments.
12. Please make sure that the position of the device during charging ensures that the mains adapter can be easily
unplugged from the power supply.
13. Fully disconnect the charger from the power supply when it is not in use for a long period of time.
14. If the emission switch is accidentally activated, an unprotected laser beam may be emitted from the fiber end
depending on the operating status. Please protect the emission switch from accidental activation.
15. Caution: laser smoke may contain viable tissue particles. Please use an extraction system.
16. Please check the condition of the applicator before use. If it is damaged, there is a risk that this may cause cuts –
do not use damaged applicators.
17. The use of flammable anaesthetic gases and oxidising gases such as nitrogen and oxygen must be avoided. Some
materials such as cotton wool that are saturated with oxygen can ignite at high temperatures, as can arise when the
device is used in accordance with its intended use. Solvents, e.g. as contained in adhesives and flammable solutions
that are used for cleaning or disinfection purposes, need time to evaporate before the laser device is operated.
18. Gases produced by the body can also be flammable!
19. Applicators and handpieces must be disinfected/sterilised using an autoclave or by spraying/wiping with
disinfectant before they are first brought into service and before and after each use.
20. It must be ensured that the disinfectant/cleaning agents used have a bactericidal (including TbB), fungicidal and
virucidal (including HBV) effect.
21. The exposure times for disinfectant/cleaning solutions given by the manufacturer must be observed.
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