Safety notes
Leica M530 OHX / Ref. 10 745 219 / Version 04 3
3 Safety notes
The Leica M530 OHX surgical microscope is state-of-the-art
technology. Nevertheless, hazards can arise during operation.
X Always follow the instructions in this user manual, and in
particular the safety notes.
3.1 Intended use
• The Leica M530 OHX 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 medical treatment.
• The Leica M530 OHX surgical microscope may be used only in
closed rooms and must be placed on a solid floor.
• The Leica M530 OHX 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
Leica M530 OHX surgical microscope's functionality.
• The Leica M530 OHX is intended for professional use only.
WARNING
Danger of injury to the eyes.
X Do not use the Leica M530 OHX in ophthalmology.
3.2 Directions for the person
responsible for the instrument
X Ensure that the Leica Leica M530 OHX surgical microscope is
used only by persons qualified to do so.
X Ensure that this user manual is always available at the place
where the Leica M530 OHX surgical microscope is in use.
X Carry out regular inspections to make certain that the
authorized users are adhering to safety requirements.
X When instructing new users, do so thoroughly and explain the
meanings of the warning signs and messages.
X Allocate responsibilities for commissioning, operation and
maintenance. Monitor compliance with this.
X Only use the Leica M530 OHX surgical microscope if it is free of
defects.
X Inform your Leica representative or Leica Microsystems
(Schweiz) AG, Medical Division, 9435 Heerbrugg, Switzerland,
immediately about any product defect that could potentially
cause injury or harm.
X If you use accessories from other manufacturers with the
Leica M530 OHX 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 to or service on the Leica M530 OHX 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 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 us), 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 Microsystem (Schweiz) AG therefore
recommends that a backup system be kept available during the
operation
3.3 Directions for the operator of the
instrument
X Follow the instructions described here.
X Follow the instructions given by your employer regarding the
organization of work and safety at work.
