3
Intended Use
3.1
Intended Purpose
The product must be used according to indication.
The purged laser fiber is intended for use with laser surgery units using wavelengths from
980–1,550 nm. The purge air stream is guided through the surrounding purge air hose
together with laser light. The laser light and the purge air stream are synchronously emitted
from a small nozzle located on the distal end of the laser fiber. Intended use is inside operating
room or practice room for the medical application on humans.
3.2
Prerequisites
The purged laser fiber can be connected to laser surgical units with a SMA, SMAplus, and
SMA-X connector.
3.3
Compatibility
The purged laser fiber may be used in connection with the laser surgical units MY30, MY60,
MY40, MY40e, diomax
Gebrüder Martin. Using other laser surgical units is permitted only if a specific certificate of
compatibility has been issued either by Gebrüder Martin or by the manufacturer of the
respective third-party laser surgical unit.
3.4
Use Restrictions
Use of the purged laser fiber is contraindicated where laser-surgical applications are
contraindicated.
3.5
Users
The user has been instructed in the safe use of laser light and medical laser surgical devices.
The purged laser fiber may be used only by expert medical personnel qualified to use the
system based on their specialized training, knowledge and experience as well as their
knowledge of the relevant regulations.
The user must be familiar with generally accepted medical practice, the current state of the art
and the contents of relevant scientific publications by medical authors.
The user must know and have mastered the surgical technique as well as the instruments and
accessories.
The user bears the responsibility for
the proper performance of the surgical procedure
•
avoiding or minimizing the general risks posed by surgical interventions
•
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, diomax
1550, Limax
Bare Fiber Universal, Purged, Single Use
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60, Limax
120 and Limax
Instructions for Use
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Revision 1