Application
182099015-V01-10.Juni2013-GA-MCL31-THAI 37
6 Application
6.1 Overview
This chapter contains detailed information on the operation and application of the laser device. Of
course, the instructions given can never replace expert knowledge of the medical application of
lasers, the careful study of relevant literature, personal experience gained under supervision and
critical assessment of the current situation.
But these instructions will be a useful support for beginners and those not working regularly with
the laser.
Therefore, we recommend that you study current medical literature and contact physicians in
private practice using this type of equipment in order to familiarize yourself with laser treatment
methods before you start to treat patients yourself.
We would like to assist you in contacting 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 from the device can cause changes in the tissue surface and
structures.
Treatment may not be given by anyone other than a practicing physician, or under the
responsibility of a practicing physician (referred to as user for simplification hereafter).
Active medical products may only be applied by users who are adequately qualified to
do so, based on their professional training background, expert knowledge and practical
experience.
Make sure you have understood the principles of laser-tissue interaction, correlation
between the individual application parameters and application techniques, as well as
the basics of laser safety.
If you have the slightest doubt, consult one or more colleagues with practical
experience and/or Asclepion Laser Technologies GmbH's application engineers
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 recorded in the Medical Device Logbook. Users must
receive instructions on 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,
• contra-indications 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 compliance of the training with all requirements of the applicable regional laws and
regulations.
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