Application
1590 99 002_1 - 21. February 2011 43
6 Application
6.1 General instructions
This chapter contains detailed information on the operation and application of the laser device. Of
course, the instructions given can never replace the expert knowledge for the medical application of
lasers, the careful study of relevant literature, the personal experience gained under supervision and
the critical assessment of the current situation.
But these instructions shall be a useful support for beginners and those not working regularly with
the laser.
Therefore, we recommend you to study current medical literature and to contact physicians in
private practices using such type of equipment in order to familiarize with the methods of laser
treatment before you start to treat patients yourself.
We would like to assist you in getting contact with other users. The responsible partner of Asclepion
Laser Technologies GmbH will readily inform you accordingly in detail.
Demands placed on the user
WARNING
The laser radiation of the device can cause thermal changes in the tissue structures.
Treatment may not be performed by anyone other than a practicing physici
the responsibility of a practicing physician (referred to as u
ser for simplification hereafter).
Active medical products may only be applied by u
sers who are adequately qualified to do
so, based on their professional training background, expe
rt knowledge and practical
experience.
Make sure you have understood the principles of laser-
tissue interaction, the correlation
between the individual application parameters, the application techniques as well as the
basics of laser safety.
If you have th
e slightest doubt, consult one or more colleagues with practical experience
and/or application engineers of Asclepion Laser Technologies GmbH before you start a
laser treatment.
Users who want to use this device must have been sufficiently informed about the safe and efficient
operation of the laser equipment described in this manual before starting to operate it. Persons
employed with or authorized by Asclepion Laser Technologies GmbH give instructions that are based
on this manual. This is to be reported in the Medical Device Logbook. The Users must get
instructions about the following aspects:
operation and intended use of the device, practical exercises included,
operating principle and functionality of the device as well as energies used,
adjustments of all operating elements,
indications for the use of the device,
contraindications and side effects,
warning labels in all operating modes,
performance of functional tests.
Further training requirements vary in the different countries. The user takes responsibility for the
compliance of the training with all requirements of the applicable regional laws and regulations.
All manuals and user guides at all-guides.com