L-1633 Rev. 3
© OmniGuide, Inc.
Page 12
WARNINGS
3.1.
Warnings for Laser Surgical Procedures
The FELS-25A is a Class IV Laser device that produces invisible beams of high-energy infrared radiation.
Improper use could result in serious personal injury. Proper electrical and Laser safety training and strict
observation of all safety precautions as specified in the Laser Instructions for Use or Operations Manual
are required to operate the device and/or provide its maintenance.
Before endoscopic instruments and accessories from different manufacturers are employed in a
procedure, the user must verify compatibility with the OmniGuide System. If in doubt, contact
OmniGuide for assistance.
Laser surgical procedures should be performed only by individuals adequately trained and familiar with
such surgical techniques. Consult medical literature regarding techniques, complications, and hazards
prior to performing these procedures.
All personnel in the immediate area of Laser use must wear eye protection specifically rated for CO
2
Lasers. Failure to do so may result in serious and permanent damage to the eyes.
The Laser should be activated only when the Laser treatment site is clearly observable and the fiber tip is
directed at it.
A fire extinguisher must be available in the operating room when the Laser is being utilized. Saline
solution or water should also be readily available.
Flammable prep solutions (e.g. alcohol-based prep solutions) must not be used during Laser procedures.
Follow established protocols for laser surgery to minimize the risk of airway fires.
A smoke evacuation system must be utilized to remove surgical plume.
With most fiber assemblies, pressurized gas exits the fiber tip during the Laser procedure and may cause
venous gas embolism. To reduce the risk of embolism, do not bring the tip into contact with blood vessels
or vascular tissue. The gas pressure delivered to the system should not exceed the pressures listed on the
insert provided with each fiber. For airway cases, the fiber should not be used below the carina. See fiber
IFU for additional fiber-specific warnings.
The pressurized gas exiting the fiber’s tip during the Laser procedure may cause temporary inflation and
separation of sub-mucosal flaps or mild emphysema under superficial layers of tissue.
Only use medical-grade Helium gas.
Do not retract, probe, or manipulate tissue with the distal-end tip of the OmniGuide fiber.
Do not use excessive force while handling the OmniGuide fiber inside an endoscopic handpiece. The use
of excessive force could potentially lead to fiber breakage or distal-end tip detachment.
The use of high Laser power along with extensive bending of the fiber may result in gas temperatures
exceeding 60
o
C, which can cause thermal damage to healthy tissue. Always use the minimum Laser
power possible for a given procedure, and minimize the amount of bending of the fiber.
Do not submerge any portion of the FELS-25A Laser/Adapter in fluid.
For sterile procedures, the use of the OmniGuide Gas Filter Unit (cat# ACC-GFU-100) is required.
There is a possibility that the OmniGuide fiber will fail to transmit light during the course of a surgical
procedure. Therefore, it is recommended that you have at least two fiber assemblies available prior to
starting a surgical procedure using the OmniGuide Laser System.
