2
IRIDEX EndoProbe
®
Handpiece, OtoProbe™ Device and FlexFiber™ Device Operator Manual
13103-EN Rev K
Warnings and Cautions
WARNINGS:
US federal law restricts this device to sale by or on the order of a healthcare practitioner
licensed by the law of the State in which he/she practices to use or order the use of the device.
Use of controls or adjustments or performing of procedures other than those specified herein
may result in hazardous radiation exposure.
Do not operate the equipment in the presence of flammables or explosives, such as volatile
anesthetics, alcohol, and surgical preparation solutions.
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 handle the fiber-optic cables with extreme care. Do not coil the cable into a diameter
less than 15 cm (6 in).
Turn off the laser before inspecting any delivery device components.
Keep the protective cap over the fiber-optic connector when the delivery device is not in use.
Follow standard facility procedures for the handling of biohazardous material after each use
of the delivery device.
Always verify that the delivery device is properly connected to the console. An improper
connection may result in an inadvertent secondary laser beam. Severe eye or tissue damage
could occur.
When using an IRIDEX probe with a non-IRIDEX laser console, ensure that the proper eye
safety filter is installed. Refer to your laser manual for specific eye safety filter information.
The IRIDEX eye safety filter (ESF) is designed to be used with an IRIDEX laser. Always
ensure that the ESF is properly connected to the laser during use.
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 relationships
among spot size, laser power, power density, and laser/tissue interaction before using an
Iridex probe.
Ophthalmic Warnings:
•
Excessive treatment power may result in a retinal hole and a retinal hemorrhage.
•
Excessive power delivered at short pulse durations may result in choroidal hemorrhage.
