Safety Notes
4
Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01
3 Safety Notes
The Leica M525 F20/CT20 surgical microscope is state-of-the-art
technology. Nevertheless, hazards may still arise during operation.
X
X
Always follow the instructions in this user manual, and in
particular the safety notes.
3.1 Intended use of instrument
• The Leica M525 F20/CT20 surgical microscope is an optical
instrument for improving the visibility of objects through
magnification and illumination. It can be applied for
observation and documentation and for human and veterinary
medical treatment.
• The Leica M525 F20/CT20 surgical microscope is subject to
special precautionary measures for electromagnetic
compatibility.
• Portable and mobile as well as stationary RF communications
equipment can have a negative effect on the reliability of the
Leica M525 F20/CT20 surgical microscope's functionality.
• The Leica M525 F20/CT20 is intended for professional use only.
WARNING
Not suitable for use in ophthalmology!
3.2 Notes on use
• The Leica M525 F20/CT20 surgical microscope mainly used for
ENT, Neuro, PRS and Dental surgeries in hospitals, clinics or
other human medical institutions.
• The Leica M525 F20/CT20 surgical microscope may only be used
in closed rooms and must be placed on a solid floor or mounted
to the ceiling.
• These Instructions for Use are intended for physicians, nurses
and other medical and technical staff who prepare, operate or
maintain the device after appropriate training. It is the duty of
the device owner/operator to train and brief all the operating
personnel.
3.3 Contraindications
The Leica M525 F20/CT20 can NOT be used in Ophthalmology.
3.4 Information for the person
responsible for the instrument
X
X
Ensure that the Leica Leica M525 F20/CT20 surgical microscope
is used only by persons qualified to do so.
X
X
The Leica M525 F20/CT20 surgical microscope may only be
operated by trained personnel.
X
X
Ensure that this user manual is always available at the place
where the Leica M525 F20/CT20 surgical microscope is in use.
X
X
Carry out regular inspections to make certain that the
authorized users are adhering to safety requirements.
X
X
When instructing new users, do so thoroughly and explain the
meanings of the warning signs and notes.
X
X
Allocate responsibilities for setup, operation and maintenance.
Monitor compliance with this.
X
X
Only use the Leica M525 F20/CT20 surgical microscope if it is
free of defects.
X
X
Notify your Leica representative or Leica Microsystems
(Schweiz) AG, Medical Division, CH-9435 Heerbrugg,
immediately if you detect a product defect that could
potentially cause injury or harm.
X
X
If you use accessories from other manufacturers with the
Leica M525 F20/CT20 surgical microscope, make sure that these
manufacturers confirm that the combination is safe to use.
Follow the instructions in the user manuals for those
accessories.
• At the end of its expected service life, dispose of the Leica M525
F20/CT20 according to the national guidelines for waste
disposal.
• Only the following accessories may be used with the
Leica M525 F20/CT20 surgical microscopes:
• The Leica Microsystems accessories described in
chapter 10.2 in this User Manual.
• Other accessories, provided that these have been expressly
approved by Leica as being technically safe in this context.
• Modifications to or service on the Leica M525 F20/CT20 surgical
microscope may be carried out only by technicians who are
explicitly authorized by Leica to do so.
• Only original parts from Leica Microsystems may be used for
maintenance work.
• After service work or technical modifications, the device must
be readjusted in accordance with our technical regulations.
• If the instrument is modified or serviced by unauthorized
persons, is improperly maintained (as long as maintenance was
not carried out by us), or is handled improperly, Leica
Microsystems will not accept any liability.