PASCAL
®
Synthesis TwinStar Ophthalmic Scanning Laser Systems
Page 17 of 142
88293-EN, Rev C
CAN/CSA-S386-2008―Laser Safety in Health Care Facilities and other national
standards as may be applicable for the country in which the laser system is used.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation.
Ocular Protection
WARNING: LASER HAZARD
Never look directly into the laser aperture or scattered laser light from reflective surfaces
when the treatment beam is activated. Severe eye damage could occur.
Never look into the path of a laser beam. Laser safety eyewear only offers protection
against stray or diffuse laser beam energy for a maximum exposure of 10 seconds.
Never substitute glass prescription eyewear for the appropriate laser safety eyewear, as
severe eye damage could occur. The glass in prescription eyewear can concentrate the
laser light onto the retina. A high power-density beam can also shatter glass prescription
eyewear, resulting in possible severe eye damage.
Do not use eyewear that is broken or damaged.
The
(laser emission) indicator is displayed on the Treatment screen to warn the user
that the system is capable of emitting laser energy. Appropriate precautions, such as
wearing appropriate eyewear in the room, should be taken.
As a precaution against accidental exposure to the output beam or its reflection, anyone
checking or adjusting calibration should wear appropriate laser safety eyewear.
Because prolonged intense light exposure can damage the retina, the use of the device
for ocular examination should not be unnecessarily prolonged and the brightness setting
should not exceed what is needed to provide clear visualization of the target structures.
The retinal exposure dose for a photochemical hazard is a product of the radiance and the
exposure time. If the value of radiance were reduced in half, twice the time would be
needed to reach the maximum exposure limit.
While no acute optical radiation hazards have been identified for slit lamps, it is
recommended that the intensity of light directed into the patient’s eye be limited to the
minimum level that is necessary for diagnosis. Infants, aphakes and persons with
diseased eyes will be at greater risk. The risk may also increase if the person being
examined has had any exposure with the same instrument or any other ophthalmic
instrument using a visible light source during the previous 24 hours. This will apply
particularly if the eye has been exposed to retinal photography.
The red diode laser aiming beam has an average
power varying from barely visible to 1
mW maximum. The safe (Class II) exposure duration limit at a maximum power level of 1
