Asclepion MeDioStar, User Manual, Page: 14 / 94

Safety
4 1590 99 002_1 - 21. February 2011
2
Safety
2.1 General information
The MeDioStar NeXT complies with the requirements of the EC Medical Device Directive
(93/42/EEC) and the German Medical Product Act (MPG).
The MeDioStar NeXT is a Class IIb medical device as per the directive in Annex IX (i.e. a surgical
invasive product that is intended to develop a biological effect that must not be confused with the
laser class!).
Like each device, the MeDioStar NeXT 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) the users in the European Union is
obliged to keep a Medical Device Logbook. A corresponding sample 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 the device is used improperly.
Absolutely observe the instructions given in this User Manual for equipment and
procedures for operating, maintaining, checking or calibrating purposes.
WARNING
The laser radiation of the device can cause, whenever low, the risk of fire. Under no
circumstances the device may be used in an explosive atmosphere (classified as AP and
APG under IEC 601-1). Take care to preclude the existence of vapors from solvents or
flammable liquids (these have been possibly 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 the safety for the staff and patients. If the tests
are not performed regularly serious health problems can be caused.
The results of such safety tests are to be reported in the Medical Device Logbook.
WARNING
Work for service, repair or modification may not be performed by anyone other than
Asclepion Laser Technologies GmbH personnel or other bodies duly authorized to handle
such work to ensure the safety for the staff and patients.
If unauthorized persons carry out service works, repairs or modifications at the device
serious health problems can be caused.