Standards And Regulations - Zeiss VISULAS YAG III Mode D'emploi

Standards and regulations

Carl Zeiss Meditec works according to a certified quality
management system.
In accordance with the relevant standards, this instrument is
equipped with an energy display, a key switch, an interlock device
and all required warning and information signs.
All relevant national accident prevention regulations for this
instrument must be observed.
In some countries, national regulations specify that this instrument
may only be used under the supervision of a medical doctor.
Warning
In the USA, this device may only be sold to a medical doctor or on the
basis of an order from a medical doctor.
This instrument is a class IV (4) laser device. The safety regulations
applying to this laser classification must be observed
This instrument is a class Ilb medical instrument as defined by the
European Medical Device Directive (MDD).
The instrument complies with the EU Medical Device Directive
93/42/EEC and its national implementation in the form of the
German Medical Products Act (MPG) (
on page 73).
To ensure proper function of the instrument, regular safety
inspections should be carried out. The instrument should be
inspected by a Carl Zeiss Meditec authorised specialist annually and
the results entered in the instrument logbook. See also chapter
Safety checks of this user manual.
An instrument logbook must be kept.
000000-1354-664 VISULAS YAG III 15.08.2005
Safety Notes
Manufacturer's Declaration
7