8 Laser safety
8.1 General laser safety information
These instructions for use are intended to minimize hazardous situations and the risk of potential harm. They include such things as:
- Safe handling and use of the device;
- Safe storage and transportation of the device;
- Use and descriptions of correct protective eyewear (i.e. wavelength range and optical density OD+);
- Information and warnings regarding direct intra-beam viewing and non-diffuse reflections;
- Appropriate maintenance instructions; and
- Clear warnings and classifications.
Human access is necessary for the performance of the function(s) of the product. During its intended use, the patient is exposed to
laser radiation; however, eye exposure must always be avoided. Dark, tattooed, or highly pigmented skin may absorb laser radiation
and cause thermal heating and discomfort. The instructions herein describe how to use the device safely on such skin conditions. The
instructions for use have been compiled and evaluated in accordance with usability safety standard IEC60601-1-6.
The laser emission from the device has been calibrated, tested and measured before product release. The actual laser output
measured in the working area does not deviate from the set value by more than ±20 %. An increase or a decrease of emission can
occur due to the following reasons:
- An increased temperature of the laser/laser chip; may decrease the emission by 10 - 20 %;
- Broken protection lenses; may increase the emission by 5 %;
- Excessive increased temperature due to component failure, resulting in a change of the component characteristics; either no
change or an increased or a decreased emission by 10 - 20 %;
- Component failure; decreases the emission, or results in no emission at all (broken circuit); and
- Dirty laser apertures (protective lenses); decreases the emission.
The equipment should be protected against unauthorized use, for example by storing the device at a controlled and inaccessible
location and permanently turned off.
The device is equipped with a stand-by/ready function. The device enters stand-by when the push-button switch is pressed to “ON”
position. In the “ON” position, the green LED on the push-button switch is activated. The transition to “ready” is clearly indicated by
repeated audible signals and the flashing of the LEDs at the laser aperture. The transition from stand-by to ready takes about 2.5
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