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Revision 5.5
Furthermore, the following additional requirements must be observed:
•
The laser surgery device MCO 25 plus may be commissioned only by authorized users. The
users must be familiar with the laser surgery device and know the applicable safety
precautions. Persons authorized to use the device must be listed in the medical product
log.
•
When the device is not in use, it must be protected against unauthorized use.
—
Remove key and store it in a safe location
•
Operation, maintenance and regular safety-related checks must be performed as described
in the instructions for use.
The operator must ensure that the following documents are always accessible and updated
regularly:
•
Medical product log or device card, respectively
•
Instructions of use for device and accessory equipment
Accident and damage reports for cases of personal injury must be reported to the relevant
authorities immediately.
3.3
Laser Safety
The laser surgery device MCO 25 plus
•
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.
CAUTION
Danger of injury to eyes, skin and other organs!
The device emits light in the invisible spectral range of 10,600 nm which may cause
irreversible damage to eyes, skin and other organs!
The direct laser beam of a class 4 laser device itself and also the laser light that is reflected
diffusely from surfaces can be harmful!
Wear protective
goggles!
Required safety goggles
D 10600 nm L4/LB4
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.
