Lightmed TruScan Pro, Руководство оператора, Страница: 10 / 109

LIGHTMED TruScan Pro – Operator’s Manual Rev. No. 01 Page 10 of 109
2.2 Warnings and Precautions
The following warnings and precautions apply to the TruScan Pro Ophthalmic Laser system and
should be observed by all users at all time:
•
DO NOT look directly into or at the laser beam or at specular laser reflections since direct and
reflected laser light from the laser aperture can cause permanent eye injury.
•
DO NOT operate the laser unless observers are using the correct protective eyewear that has
an optical density of OD4 or higher that accommodates this laser system. The OD information
must be visible on the eyewear.
•
DO NOT use objects that can readily reflect light in the vicinity of the laser beam to avoid
reflecting the beam in a hazardous manner.
•
DO NOT fire the laser directly onto flammable agents or gasses as the focused laser beam
may cause ignition. There is no AP/ APG protection.
•
DO NOT try to service or repair the laser other than what is included in this manual. Service
should only be performed by authorized and trained technicians.
•
DO NOT fire the laser on patients without checking the operation of the laser and verifying the
optical alignment of the laser treatment beam.
•
ALWAYS use the lowest power settings possible when treating patients and start the
treatment with minimum power setting.
•
ALWAYS set the correct spot size and/or use the most appropriate one for the power setting
and type of procedure that is to be performed.
•
DO NOT put the laser into
‘READY’ mode until ready to operate on the patient.
•
DO NOT inhale any laser plume generated by the laser during surgery. Personnel should take
precautions, such as wearing surgical masks or use plume evacuation systems, when a
treatment is undergoing.
o
Caution ! Laser plume may contain viable tissue particulates.
•
ALWAYS take extra care of the optical fibers that connect the LDUs to the console to make
sure they do not get damaged. Additional clinical warnings may be found in Section 6 Clinical
Use in this Manual.
•
ALWAYS make sure the Laser has its own dedicated power outlet. Additional items may be
plugged in a Multiple Portable Socket Outlet, which may be plugged into an additional outlet.
•
DO NOT use the Laser Console if the ambient temperature is outside the range of 20°C-35°C,
which is the rated operating temperature limits where the Laser system can be guaranteed to
operate without any interruptions. Outside this range of temperature, it is possible for the Laser
to generate an error condition where a message is displayed, and the system goes into
STANDBY mode until the internal temperature returns to normal limits. Only then the Laser
can be used again but the error condition may reoccur unless the rated temperature comes
within limits.
2.3 Optical Hazards
The guidance for the safe use of Lasers and Laser systems can be found in Standards IEC60825-
1, USA 21CFR 1040.10 and 1040.11, as well as ANSI Z136.1-1986. During normal operations of
the TruScan Pro Laser, the operator is protected from Laser hazards by built-in optical absorption
Safety Filters. All other personnel in the area should wear protective eyewear to eliminate the risk
of eye injury occurring.