Safety notes
• Use of accessories and cables other than those specified or
provided by the manufacturer of his equipment could result in
increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in
improper operation.
• The Leica M620 F20 surgical microscope may be used only in
closed rooms and must be placed on a solid floor.
• Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the Leica M620 F20,
including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
The emissions characteristics of this equipment make it
suitable for use in industrial areas and hospitals (CISPR 11
class A). If it is used in a residential environment (for which
CISPR 11 class B is normally required), this equipment
might not offer adequate protection to radio-frequency
communication services. The user might need to take
mitigation measures, such as re-locating or re-orienting
the equipment.
User qualifications
The Leica surgical microscope may only be used by physicians and
medical assistance personnel with appropriate qualifications who
have been instructed in the use of the instrument. Specific training
is not required.
3.5 Directions for the operator of the
instrument
• Follow the instructions described here.
• Follow the instructions given by your employer regarding the
organization of work and safety at work.
• Check the illumination intensity before and during surgery.
• Do not move the system without released brakes.
• Operate the system only with all equipment in its proper
position (all covers fitted, doors closed).
• To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
• All parts of the instrument shall not be serviced or maintained
while in use with a patient.
• Lamps shall not be changed while in use with a patient.
Phototoxic damage to the retina during eye surgery
WARNING
Damage to the eyes due to prolonged exposure!
The light of the instrument may be harmful. Risk of eye
damage increases with the duration of exposure.
X
During exposure to the light from this instrument, do
not exceed the hazard reference values. For this
instrument, an exposure time of over 3 min 35 seconds
at maximum output power exceeds the hazard
reference value.
The following table is intended to serve as a guideline and make
the surgeon aware of the potential hazard.
The data have been calculated for the worst-case scenario:
• Eye with aphakia
• Completely unmoving eye (continuous irradiation of the same
region)
• Uninterrupted light exposure, e.g. no surgical instruments in the
eye
• Pupils dilated to 7 mm
The calculations are based on the corresponding ISO standards
1) 2)
and the exposure limit values recommended in them. Published
literature shows that a moving eye may allow for increased time of
exposure
3)
.
Leica M620 F20 / Ref. 10 714 371 / Version 01
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