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1 Important information regarding safe use
55000-00011_002_01 – 1756789 – 2017-09-06
Surgical lighting system
Definition: Surgical lighting system
A surgical lighting system consists of two or multiple small surgical lamps and is
usable without restrictions.
1.8.5
Special features
High light intensity
The light heads provide high light intensity to ensure good visual conditions for the
surgeon.
Overlap of the light fields
• Visible light generates heat in the operating area, due to physical effects. High
irradiation densities are generated when the light fields of several light heads
overlap. This can cause drying of tissue and, particularly after prolonged
exposure, reduced perfusion and tissue damage. The light intensity must be
reduced when perfusion is reduced or the tissue starts to dry out.
Surgical interventions in the field of vision
• For operations in the field of vision with unprotected and open eyes, high levels
of local light intensities of surgical lamps or direct visual contact with the laser
beam may lead to damage to eyesight. The patient's eyes must be closed or
protected as necessary (e.g. with safety goggles with an optical density of at least
2 or designed according to protection level 6 EN169).
• The laser used in the ALC plus function to measure distance is classified as a class
2 laser, and has the following specifications:
– max. output power 0.95 mW
– wave length -620-690 nm,
– beam divergence 0.16 x 0.6 mRad
– pulse duration 0.4 x 10 ^ -9 s
– pulse refresh rate 320 MHz.
1.8.6
Improper use
Improper use
• Additional load on the light support is not permitted.
• The device may not be exposed to severe vibration.
Restriction
• The device is not suitable for operation in areas at risk of explosions
• The device should not be used in the vicinity of strong magnetic fields
• The device is not suitable for use in rooms or areas in which inflammable
mixtures of anaesthetics with air or oxygen or laughing gas (N
2
0) are used.
• Mixtures of combustible anaesthetic vapours with oxygen or laughing gas may
arise in the vicinity of the device in such a high concentration that ignition could
occur under certain circumstances. The danger area according to EN 11197 lies in
an area between 5 cm and 25 cm from the point of outflow or escape of the gas.
1.9
Ambient conditions for operation and storage
Various ambient conditions apply to the operation and temporary storage of the
device.
1.9.1
Ambient conditions for operation
• Ambient temperature:
10°C to 40°C;
• Relative humidity:
30 % to 75 %;
• Air pressure:
700 hPa to 1060 hPa
• Operating height
up to 3000 m above sea level
1.9.2
Ambient conditions for storage
• Ambient temperature:
-15°C to 60°C;
• Relative humidity:
5 % to 95 %;
• Air pressure:
500 hPa to 1060 hPa
