Performance Of Your Leica Microsystems Surgical Microscope; Safety Notes; Intended Use; Directions For The Person Responsible For The Instrument - Leica PROVEO 8 User Manual

3

Safety notes

The PROVEO 8 surgical microscope is state-of-the-art technology.
Nevertheless, hazards can arise during operation.
Always follow the instructions in this user manual, and in
X
particular the safety notes.
3.1

Intended use

• The PROVEO 8 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 major field of use is Ophtalmology.
• The microscope device is not for use in microsurgery (Neuro,
Plastic/Reconstructive, Ear, Nose and Throat surgeries).
• The PROVEO 8 surgical microscope may be used only in closed
rooms and must be placed on a solid floor or mounted to the
ceiling.
• It is available on the floor stand F42 and on the telescope mount
CT42.
The F42 is a floor stand for three-dimensional positioning of the
PROVEO 8 in the room.
The CT42 is a ceiling mounted electrical linear actuator for
lifting and lowering the PROVEO 8. It is operated by a hand
switch.
• The PROVEO 8 surgical microscope is subject to special
precautionary measures for electromagnetic compatibility. It
must be installed and commissioned in accordance with the
guidelines and manufacturer's declarations and recommended
safety distances (according to EMC tables based on
EN60601-1-2).
• Portable and mobile as well as stationary RF communications
equipment can have a negative effect on the reliability of the
PROVEO 8 surgical microscope's functionality.
• Always release the brakes to move or relocate the PROVEO 8
surgical microscope.
• The essential performance of the PROVEO 8 is to provide
illumination and mechanical stability of the optics carrier in any
position.
3.2 Directions for the person
responsible for the instrument
Ensure that the PROVEO 8 surgical microscope is used only by
X
persons qualified to do so.
Ensure that this user manual is always available at the place
X
where the PROVEO 8 surgical microscope is in use.
Carry out regular inspections to make certain that the
X
authorized users are adhering to safety requirements.
When instructing new users, do so thoroughly and explain the
X
meanings of the warning signs and messages.
Allocate responsibilities for commissioning, operation and
X
maintenance. Monitor compliance with this.
The PROVEO 8 is intended for professional use only.
X
WARNING
Risk of electric shock!
X
Only use the PROVEO 8 surgical microscope if it is free of
X
defects.
Inform your Leica representative or Leica Microsystems
X
(Schweiz) AG, Medical Division, 9435 Heerbrugg, Switzerland,
immediately about any product defect that could potentially
cause injury or harm.
If you use accessories from other manufacturers with the
X
PROVEO 8 surgical microscope, make sure that these
manufacturers confirm that the combination is safe to use.
Follow the instructions in the user manual for those accessories.
• Modifications, installations to or service on the PROVEO 8
surgical microscope may be carried out only by technicians who
are explicitly authorized by Leica to do so.
For further details refer to the installation manual.
• Only original Leica replacement parts may be used in servicing
the product.
• After service work or technical modifications, the device must
be readjusted in accordance with our technical specifications.
• If the instrument is modified or serviced by unauthorized
persons, is improperly maintained (as long as maintenance was
not carried out by a qualified trained service engineer), or is
handled improperly, Leica Microsystems will not accept any
liability.
• The effect of the surgical microscope on other instruments has
been tested as specified in EN 60601-1-2. The system passed the
emission and immunity test. Comply with the usual pre-
cautionary and safety measures relating to electromagnetic and
other forms of radiation.
• The electric installation in the building must conform to the
national standard, e.g., current-operated ground leakage
protection (fault-current protection) is suggested.
• Like any other instrument in the operating theater, this system
may fail. Leica Microsystems (Schweiz) AG therefore
recommends that a backup system be kept available during the
operation.
PROVEO 8 / Ref. 10 733 910 / Version 02
Connect this equipment only to a supply mains with
protective earth.
Safety notes
3