claros pico user manual V 2.1 page 8 of 34
2
Warning notices
2.1
Warning notices – personal ha ard
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 evice may only be sol to or on behalf of a entist.
2. The energy emitte by the laser light excee s the tolerance threshol of the eye an can therefore lea to
irreversible amage to the eye. The prescribe safety glasses must be worn by all persons in the treatment room in
or er to prevent eye amage. The pilot laser (target beam) is automatically switche on when an application
program is starte . Do not look into the beam.
3. Safety glasses with filter level 5 or higher at 808 nm bearing the CE marking in accor ance 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 observe when using laser safety glasses.
4. The laser anger zone (referre to as the 'treatment room' in the following) is the entire area locate within the
range of the laser beam. Warning! As reflections from instruments an equipment intro uce into the beam path are
possible, the laser anger zone is only elimite by obstacles aroun the laser system that are not transparent with
regar to laser ra iation (e.g. walls, ceiling, floor, close oors) . An NOHD value ( istance from which the laser can
be observe safely) is not given ue to the high mobility of the laser aperture. The entire room in which the laser is
operate must be treate as the laser protection area.
5. The room in which the evice is operate must be equippe in accor ance with the BGV B2 acci ent 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 appointe by the operator. The BGV B2 acci ent prevention regulations can be
obtaine from elexxion AG upon request.
6. The operator of the laser system must ensure that the treatment room is clearly marke an that nobo y enters
the treatment room without safety glasses (see item 2) while the laser is being use .
7. Use is only permitte in rooms esigne for me ical purposes an which meet the above requirements. Use
anywhere else is not allowe .
8. Only accessories specifie by elexxion AG may be use . A list of all accessories can be foun in Section 6 of these
instructions for use. In case of oubt, please consult your me ical pro uct consultant.
9. Use of the operating equipment in any way other than that escribe here may result in angerous irra iation.
10. The evice may not be use in explosive atmospheres, irrespective of how these are create .
11. People must not look into the laser beam irectly or through optical evices or instruments.
12. Please make sure that the position of the evice uring charging ensures that the mains a apter can be easily
unplugge from the power supply.
13. Fully isconnect the charger from the power supply when it is not in use for a long perio of time.
14. If the emission switch is acci entally activate , an unprotecte laser beam may be emitte from the fiber en
epen ing on the operating status. Please protect the emission switch from acci ental activation.
15. Caution: laser smoke may contain viable tissue particles. Please use an extraction system.
16. Please check the con ition of the applicator before use. If it is amage , there is a risk that this may cause cuts –
o not use amage applicators.
17. The use of flammable anaesthetic gases an oxi ising gases such as nitrogen an oxygen must be avoi e . Some
materials such as cotton wool that are saturate with oxygen can ignite at high temperatures, as can arise when the
evice is use in accor ance with its inten e use. Solvents, e.g. as containe in a hesives an flammable solutions
that are use for cleaning or isinfection purposes, nee time to evaporate before the laser evice is operate .
18. Gases pro uce by the bo y can also be flammable!
19. Applicators an han pieces must be isinfecte /sterilise using an autoclave or by spraying/wiping with
isinfectant before they are first brought into service an before an after each use.
20. It must be ensure that the isinfectant/cleaning agents use have a bacterici al (inclu ing TbB), fungici al an
viruci al (inclu ing HBV) effect.
21. The exposure times for isinfectant/cleaning solutions given by the manufacturer must be observe .
