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Instructions for Use
Laser Surgical Unit diomax
Furthermore, the following additional requirements must be observed:
The device may be commissioned by authorized users only. The users must be familiar
•
with the laser device and know the applicable safety precautions. The persons authorized
to use the device must be listed in the medical product log.
•
The training of the personnel is to be repeated annually and must be documented by the
users in written form.
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 this document.
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 submitted to the relevant
authorities immediately.
Revision 2
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1550
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