Service manual LIMAX
120
Service manual version 1.00
page 4
2.2
Laser safety
The LIMAX
®
120 laser:
•
is a Class IIb unit acc. to the Medical Devices Act (or MDD, respectively)
•
is a Class 4 laser unit (acc. to DIN EN 60825-1)
•
carries the CE-mark in compliance with EU Directive 93/42/EEC (MDD).
The “laser area” is defined as the area in which the maximum permissible exposure (MPE)
values that are normally binding may be exceeded, taking any accidental deflection of the
laser beam into consideration as well.
Therefore, the following safety measures must be strictly observed:
•
All doors providing access to the laser area must be marked by warning lamps.
•
At least once a year, the persons working in the laser area must be informed on
relevant safety requirements and measures to be taken, and must be instructed in the
correct use of the device. Such instruction must be recorded, together with a list of all
participants.
•
All persons present in the laser area, without exception, must wear protective goggles
when the laser is switched from “STANDBY” to “LASER READY”:
Acc. to DIN EN 207, the goggles required for protection against LIMAX
®
120
laser radiation must be rated “D 1318 nm L6” or higher.
•
The patient’s eyes need to be protected as well.
•
It is the responsibility of the operator of the unit to provide suitable protective
equipment.
•
Never stare directly into the red pilot laser light! Be aware that the afore-mentioned
protective goggles do not protect against the red pilot laser radiation.
Caution!
Danger of damage to eyes, skin or other organs!
The unit emits radiation in the non-visible spectral range of 1318 nm.
Be aware that such radiation could cause irreversible damage to the
eyes, skin and other organs!
