Intended Use; Directions For The Person Responsible For The Instrument - Leica M525 OH4 User Manual

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The Leica M525 OH4 surgical microscope is state-of-the-art
technology. Nevertheless, hazards can arise during operation.
➩Always follow the instructions in this user manual, and in par-
ticular the safety guidelines.

Intended use

• The Leica M525 OH4 surgical microscope is an optical instru-
ment for improving the visibility of objects through magnifica-
tion and illumination. It can be applied for observation and
documentation and for human and veterinary medical
treatment.
• The Leica M525 OH4 surgical microscope may be used only in
closed rooms and must be placed on a solid floor.
• The Leica M525 OH4 surgical microscope is subject to
special precautionary measures for electromagnetic compat-
ibility. They must be installed and put into operation in accor-
dance with the guidelines, manufacturer's declarations and
recommended safety distances (Tables 201, 202, 204, and 206
according to EN 60601-1-2:2001).
• Portable and mobile as well as stationary RF communications
equipment can have a negative effect on the reliability of the
Leica M525 OH4 surgical microscope.
Warning 12
Not suitable for use in ophthalmology!
Directions for the person responsible for
the instrument
➩Ensure that the Leica M525 OH4 surgical microscope is used
only by persons qualified to do so.
➩Ensure that this user manual is always available at the place
where the Leica M525 OH4 surgical microscope is in use.
➩Carry out regular inspections to make certain that the
authorized users are adhering to safety requirements.
➩When instructing new users, do so thoroughly and explain
the meanings of the warning signs and messages.
➩Assign individual responsibilities for starting, operating and
servicing the Leica surgical microscope and monitor the
observance of these responsibilities.
➩Only use the Leica M525 OH4 surgical microscope if it is free
of defects.
➩Inform your Leica representative or Leica Microsystems
(Schweiz) AG, BU SOM, 9435 Heerbrugg, Switzerland,
immediately if you detect a product defect that could
potentially cause injury or harm.
➩If you use accessories made by third-party manufacturers
with the Leica M525 OH4 surgical microscope, be sure that
each such manufacturer confirms the safety-engineering,
harmless usability of the product and observe the product's
user manual.
➩Modifications to or service on the Leica M525 OH4 surgical
microscope may be carried out only by technicians who are
explicitly authorized by Leica to do so.
➩Only original Leica replacement parts may be used in servic-
ing the product.
➩After servicing or making technical modifications, the instru-
ment must be re-set in accordance with our technical specifi-
cations.
➩Leica accepts no liability if the instrument is modified or
serviced by unauthorized persons, not maintained as
specified (unless maintenance is performed by us) or not
used/handled properly.
➩Interaction of other devices through the Leica surgical micro-
scope was proven in accordance with EN 60 601-1-2. The
system passed the emission and immunity test. The standard
safety precautions and safety requirements relating to
electromagnetic and other radiation must be observed.
➩Domestic electrical installation must be conducted in
accordance with the national standard, e.g. use of a residual
current protective device (FI protection) is recommended.
➩As with every other instrument used in operative
applications, this system is subject to failure. Leica
Microsystem (Schweiz) AG therefore recommends that a
backup system be kept available during the operation.
Leica M525 OH4 / Ref. 10 714 367 / Version -
Use
57

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