Safety notes
M822 / Ref. 10 743 504 / Version 01 5
appropriate qualifications who have been instructed in the use
of the instrument. Specific training is not required.
•
Connecting electrical equipment to the Auxiliary Power outlet
will result in the establishment of a “ME System” and may result
in a reduced level of safety. The corresponding standard
requirements for “ME Systems” must be observed.
•
All parts of the M822 shall not be serviced or maintained while
in use with a patient.
•
Lamps shall not be changed while in use with a patient.
•
Use of this equipment adjacent to other equipment should be
avoided because it could result in improper operation. If such
use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
•
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.
•
Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used
no closer than 30cm (12inches) to any part of the Leica M822,
including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
Note:
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 relocating or re-orienting the
equipment.
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.
Don't move system without released brakes.
Operate the system only with all equipment in its proper
position (all covers tted, doors closed).
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.
During exposure to the light from this instrument, do
not exceed the hazard reference values.
An exposure to this instrument for longer than 2.8 min
at maximum output power exceeds the exposure limits.
Observe the warning messages in the "Safety Notes"
chapter on page 37.
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. With a
moving eye, a factor of 5 to 10 can be applied to these limit
values
3)
.
Main light
Light setting
Recommended maximum exposure time according to
1)
[min.]
Without filter With GG435 filter With GG475 filter
25 % 77 116 270
50 % 19 28 64
75 % 7 11 25
100 % 3 5 12
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