Safety Notes
29
Leica HM500/Ref. 10 715 697/Version B
Although the Leica HM500 headmounted microscope is a state-
of-the-art system, hazards may still arise during operation.
➩
For this reason, you must always follow the directions given
in this user manual, particularly the safety instructions.
Intended use
• The Leica HM500 headmounted microscope is an optical
instrument which uses magnification and illumination to make
objects more visible. It can be used for observation, docu-
mentation as well as in human and veterinary surgery.
• The Leica HM500 headmounted microscope may only be
used in closed rooms with a hard floor.
• The Leica HM500 headmounted microscope is subject to
special precautionary measures relating to electromagnetic
compatibility. It must be installed and operated in conformity
with the guidelines and manufacturer’s declarations and rec-
ommended safe clearances (Tables 1, 2, 4 and 6 in EN 60601-
1-2:2001).
• Portable, mobile and also fixed high-frequency communica-
tion devices can have a negative effect on the functionality
of the Leica HM500 headmounted microscope.
Warning
Do not use in ophthalmology!
Leica HM500 Dental is not suitable for use in
operating rooms.
Directions for the person responsible for
the instrument
• Ensure that only qualified personnel use the Leica HM500
headmounted microscope.
• Ensure that this user manual is always on hand and available
with the Leica HM500 headmounted microscope.
• Carry out regular inspections to make sure personnel are
complying with safety requirements.
• Brief the user thoroughly and explain the meaning of the
hazard signs and safety precautions.
• Allocate responsibilities for start-up, operation and mainte-
nance. Monitor compliance with this.
• Only use the Leica HM500 headmounted microscope if it is
free of defects.
• If any product faults develop which might put the safety of
people at risk, report this immediately to your Leica dealer
or to Leica Microsystems (Schweiz) AG, Surgical Division,
CH-9435 Heerbrugg.
• The Leica HM500 is not an explosion-protected design and
therefore is not suitable for use with flammable mixtures of
anesthetics and air or with flammable mixtures of anesthetics
and oxygen or nitrous oxide. Caution is also advised when
disinfecting the Leica HM500.
• The device is not approved for use in areas subject to explo-
sion hazards.
• If you use accessories from other manufacturers with the
Leica HM500 headmounted microscope, make sure that these
manufacturers have confirmed that the combination is safe to
use. Follow the instructions in the user manual for those
accessories.
• Modifications and maintenance to the Leica HM500 head-
mounted microscope may only be performed by professionals
expressly authorized by Leica.
• Only original Leica parts are to be used in maintenance work.
• After maintenance or technical modifications, the device
must be readjusted in accordance with our technical specifi-
cations.
• If the device is modified or maintenance has been performed
by unauthorized personnel, if the instrument is improperly
maintained (providing the maintenance was not performed by
us) or if the device has been operated improperly, this will
relieve Leica of all liability.
• The effect of the Leica HM500 headmounted microscope
on other instruments has been tested as specified in
EN 60 601-1-2. The system has passed the tests relating to
emissions and immunity. The usual precautionary and safety
measures relating to electromagnetic and other forms of radi-
ation must be complied with.
• Use only the power cables supplied (max. 2.5 m).
Longer or different power cables may result in increased
emissions or in a reduced noise immunity of the device or
system.
• The building’s electrical wiring must comply with the relevant
national standards.
We recommend using a current-operated ELCB system (RCB).
• Like any other instrument in the operating theater, this system
may fail. Leica Microsystems (Schweiz) AG therefore recom-
mends keeping a spare system on hand during the operation.
