Directions For The Operator Of The Instrument - Leica M844 User Manual

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 M844 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 30 cm (12 inches) to any part of the Leica M844,
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.
X
Follow the instructions given by your employer regarding the
X
organization of work and safety at work.
Check the illumination intensity before and during surgery.
X
Don't move system without released brakes.
X
Operate the system only with all equipment in its proper
X
position (all covers fitted, 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.
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
and the exposure limit values recommended in them. Published
literature shows that a moving eye may allow for increased time of
exposure
Main light
Light setting
25 %
50 %
75 %
100 %
10 % - Retina
Protection
Function
Active
M844 / Ref. 10 713 294 / Version 01
During exposure to the light from this instrument, do
X
not exceed the hazard reference values.
If the exposure time exceeds 2 min with this instrument
at maximum output power, the hazard reference value
will be exceeded.
3)
.
Recommended maximum exposure time according to 1)
Without filter With GG435 filter
55 min
12 min
4 min
2 min
3 h 19 min
Safety notes
1) 2)
[min.]
With GG475 filter
1 h 4 min 3 h 3 min
15 min 44 min
5 min 17 min
2 min 8 min
n/a n/a
5