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Safety notes
OttoFlex™ illuminator
Recommended maximum exposure time according to 1)
Light setting
25 %
50 %
75 %
100 %
20 % - Retina
Protection
Function
Active
Sources:
1)
DIN EN ISO 15004-2:2007 Ophthalmic instruments –
Fundamental requirements and test methods – Part 2: Light
hazard protection.
2)
ISO 10936-2:2010 Optics and photonics – Operation
microscopes/Part 2: Light hazard from operation microscopes
used in ocular surgery.
3)
David Sliney, Danielle Aron-Rosa, Francois DeLori, Franz
Fankhauser, Robert Landry, Martin Mainster, John Marshall,
Bernhard Rassow, Bruce Stuck, Stephen Trokel, Teresa Motz
West and Michael Wolffe, Adjustment of guidelines for
exposure of the eye to optical radiation from ocular
instruments: statement from a task group of the International
Commission on Non-Ionizing Radiation Protection (ICNIRP)
APPLIED OPTICS, Vol. 44, No. 11, p. 2162 (10 April 2005).
Protect the patient with the following safeguards:
• Short illumination times
• Low brightness setting
• Use of protective filters
• Switching off the illumination during breaks in the operation
It is recommended to adjust the brightness to the minimum
necessary for the surgery. Infants, patients with aphakia (whose
eyelens has not been replaced by an artificial lens with a UV
protection screen), small children and persons with diseases of the
eye are at greater risk. The risk is also increased if the person being
treated or operated on has, within the last 24 hours, already been
exposed to illumination from the same or any other
ophthalmological instrument that uses a bright visible light source.
This applies especially to patients that have been examined via
retinal photography.
The decision about which light intensity to use for an application
must be made on a case-by-case basis. In any event, the surgeon
must evaluate the risks and benefits of the used light intensity.
Despite all efforts to minimize the risk of retinal injury by surgical
microscopes, damage may still occur. Photochemical retinal
damage is a possible complication of the necessity to use bright
light to make eye structures visible during difficult
ophthalmological processes.
6
[min.]
Without filter
1 h 9 min
14 min
5 min
2 min
1 h 42 min
M844 / Ref. 10 713 294 / Version 01
In addition, the Retina Protection function can be activated during
the surgery to reduce the main light intensity up to 10% and
OttoFlex up to 20%.
Stability (floor stands only)
When moved in the operating room, the swing arm must be folded
up and locked and the brakes must be applied, otherwise the swing
arm could drift out of control and the stand could topple.
Hazards due to movable parts
This section describes uses that, inadvertently, could lead to
hazardous situations.
• Add accessories and balance the stand before the operation,
and never over the field of operation.
• Never put your hand between the gas spring and the swing
arm; it could become trapped when the swing arm is moved.
• Do not put your fingers between the microscope and the
focusing drive; They could get crushed.
Floor stand
• Always push the instrument to move it; never pull it. Feet in
lightweight shoes could become trapped beneath the casing of
the base.
• The footbrakes must remain engaged throughout the
operation.
Electrical connections
The control unit may be opened only by a Leica-approved service
technician.
Accessories
Only the following accessories may be used with the Leica M844
surgical microscopes:
• The Leica Microsystems accessories described in this User
Manual.
• Other accessories, provided that these have been expressly
approved by Leica as being technically safe in this context.
3.6
Dangers of use
WARNING
Danger of injury due to:
• uncontrolled lateral movement of the arm system,
• tilting of the stand,
• trapping of feet in lightweight shoes beneath the casing
of the base.
For transportation, always move the M844 surgical
X
microscope into the transport position.
Never move the stand while the unit is extended.
X
Never roll the stand or OP equipment over the cables
X
lying on the floor.
Always push the M844 surgical microscope; never pull it.
X
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