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3.3
Laser Safety
The laser surgery unit diomax
is a class IIb device acc. to MPG (Medical Devices Act),
•
is a class 4 laser device (acc. to IEC 60825-1),
•
has the CE label acc. to directive 93/42/EEC.
•
WARNING
Danger of injury to eyes, skin and other organs!
The device emits light in the invisible spectral range of 1,550 nm, which can cause
irreversible damage to eyes, skin and other organs!
Both the direct laser beam of a class 4 laser device itself and the laser light that is reflected
diffusely from surfaces can be harmful!
Wear protective
goggles!
The laser range is the range in which the values for the permitted maximum radiation can be
exceeded. However, be aware that the laser beam may be deflected unintentionally.
Therefore, the following safety precautions must be strictly complied with:
All accesses to the laser areas must be marked with warning lamps.
•
Persons working in the laser area must be informed about safety regulations and
•
precautions and instructed in the operation of the device at least once per year. This
training must be documented in written form including a list of all participants.
All persons present in the laser area during laser operation must – without exception –
•
wear protective goggles when the mode is switched from "STANDBY" to "LASER READY":
Laser protection goggles according to EN 207 for diode laser radiation with a
protection class of D 1550 nm L4/LB3 or higher.
The patient's eyes must be protected.
•
The operator is responsible for provision of appropriate protective equipment.
•
Do not directly look into the red pilot laser light! The protective goggles mentioned above
•
do not protect from the red pilot laser light.
16
®
1550
Required safety goggles:
D 1550 nm L4/LB3
Instructions for Use
Laser Surgical Unit diomax
®
1550
Revision 2
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