Iridex TxCell SSLA, Руководство оператора

Страница: 6 / 38

2 70375-EN Rev B
Warnings and Cautions
WARNINGS :
Lasers generate a highly concentrated beam of light that may cause injury if improperly used. To protect the
patient and the operating personnel, the entire laser and the appropriate delivery system operator manuals
should be carefully read and comprehended before operation.
Never look directly into the aiming or treatment beam apertures or the fiber-optic cables that deliver the laser
beams with or without laser safety eyewear.
Never look directly into the laser light source or at laser light scattered from bright reflective surfaces. Avoid
directing the treatment beam at highly reflective surfaces such as metal instruments.
Ensure that all personnel in the treatment room are wearing the appropriate laser safety eyewear. Never
substitute prescription eyewear for laser safety eyewear.
Always keep the Iridex laser in Standby mode when you are not treating a patient. Maintaining the Iridex
laser in Standby mode prevents accidental laser exposure if the footswitch is inadvertently pressed.
If you are using a beam splitter, you must install the fixed ESF for the appropriate wavelength before
installing the beam splitter.
Avoid over-treatment of targeted tissue by using the lowest power density. Please refer to “Treating
Patients” in Chapter 2.
Ensure pattern covers only the desired treatment area prior to footswitch actuation.
Reaction time can exceed rate of treatment spot delivery in either single-spot repeat or multi-spot pattern
mode. This can result in delivery of laser applications after intended release of the footswitch prior to
completion of a pattern.
The relationship between spot size and resultant power density is not linear. Halving the spot size
quadruples the power density. The physician must understand the relationship among spot size, laser power,
power density, and laser/tissue interaction before using the TxCell Scanning Slit Lamp Adapter.
Always inspect the fiber-optic cable before connecting it to the laser to ensure that it has not been damaged.
A damaged fiber-optic cable could cause accidental laser exposure or injury to yourself, your patient, or
others in the treatment room.
Always verify that the delivery device is properly connected to the laser. An improper connection may result
in an inadvertent secondary laser beam. Severe eye or tissue damage could occur.
Do not use the delivery device with any laser system other than an Iridex laser. Such use may void product
warranties and jeopardize the safety of the patient, yourself, and others in the treatment room.
Tissue absorption is directly dependent upon presence of pigmentation; therefore, dark pigmented eyes will
require lower energies to obtain equivalent results as compared to light pigmented eyes.
Observation equipment such as a beam splitter or co-observation tube must be installed between the ESF and
the oculars.
To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective
earth. EN60601-1:2006/AC; 2010 16-2 (C)