Safety
4 182099015-V01-10.Juni2013-GA-MCL31-THAI
2 Safety
2.1 Overview
The MCL 31 Dermablate complies with the requirements of the EC Medical Device Directive
(93/42/EEC) and the German Medical Product Act (MPG).
The MCL 31 Dermablate is a Class IIb medical device as defined in the directive in Annex IX (i.e.
a surgical invasive product that is intended to have a biological effect – this must not be confused
with the laser class!).
Like each device, the MCL 31 Dermablate may lead to potential risks when operated. The user
should be aware of them before starting the system. Among these risks are optical, electrical and
biological dangers as well as fire hazards.
Observe the national regulations applicable for the operation of a medical product.
According to the EC Medical Device Directive (93/42/EEC), users in the European Union are
obliged to keep a Medical Device Logbook. A corresponding example is delivered with the device.
WARNING
The laser device emits high levels of radiation in the infrared range that may cause
serious damage to the eye if it is used improperly.
It is mandatory to observe the instructions given in this User Manual for the equipment
and its operating, maintaining, checking or calibrating procedures.
WARNING
The device's laser radiation, however low, carries a risk of fire. Under no circumstances
may the device may be used in an explosive atmosphere (classified as AP and APG
under IEC 601-1). Take care to preclude vapors from solvents or flammable liquids
(these may have been used for cleaning or disinfection) in the room before you start
working with the laser.
WARNING
Please note that this product is subject to scheduled technical safety tests that must be
performed at annual intervals to ensure safety for staff and patients. If the tests are not
performed regularly, serious health problems may arise.
The results of such safety tests are to be reported in the Medical Device Logbook.
WARNING
Servicing, repairs or modifications may not be performed by anyone other than
Asclepion Laser Technologies GmbH personnel or other bodies duly authorized to
handle such work, to ensure safety of the staff and patients.
If unauthorized persons carry out servicing, repairs or modifications of the device
serious health problems may arise.
WARNING
The instrument must be installed and operated according to CAN/CSA-Z386-92: Laser
safety in health care facilities.
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