L-1670 Rev 0
13
© OmniGuide, Inc.
Sterility Warnings
The OmniGuide fiber is supplied sterile for one-time use. The method of sterilization is
radiation. Consult relevant OmniGuide fiber IfU for handling instructions
Do not use the fiber product if the package is damaged, opened, or if sterility is compromised.
Wear sterile gloves and observe proper surgical aseptic technique while handling the sterile fiber.
Do not use an OmniGuide Adapter in a sterile procedure without the Gas Filter Unit (cat# ACC-GFU-100).
Use sterile drape to cover articulating arm during sterile procedures.
Accessories (micromanipulators and handpieces) must be cleaned and/or sterilized before
the procedure using methods described in the IfUs provided for accessories.
6.0 CAUTIONS
Cautions for Laser Surgical Procedures
Physicians performing Laser procedures should be trained and compliant with their relevant health care facility requirements in:
• Laser safety (ANSI-Z136.1)
•
Clinical use of CO
2
Lasers
•
The use of the OmniGuide System
Build-up of tissue or tissue debris on the distal-end tip of the OmniGuide fibers or handpiece can result in overheating of the
device. If build-up/contamination occurs during use, clean the tip by dipping into saline solution. Refer to OmniGuide fiber IFUs
for specific instructions on how to clean fiber tips during surgical procedures. Replace the fiber if performance does not improve.
The OmniGuide fiber is a single use device. Reuse of fiber voids all warranties of sterility and is prohibited.
Do not bend the OmniGuide fiber to a radius less than the minimum radius and maximum angle specified for the fiber (typically
3cm, 30 degree). Bending the fiber below this limit may cause fiber failure. Refer to fiber IFUs for more instructions on fiber usage.
To assure the proper functioning of the device, The BEACON Advanced Energy Laser System
must be serviced be performed by an OmniGuide authorized representative.
After a surgical procedure, visibly inspect the integrity of the OmniGuide fiber. In
particular, verify that no portion of the fiber is missing or detached.
Excessive bending of OmniGuide fiber will lower its output power. Please consult fiber IFUs for the
minimum allowable bending radius and angle of the fiber. Do not kink or pinch the Fiber.
The OmniGuide System is not currently compatible with optical scanners.
Reflected Energy Protection
Do not aim laser beam at the reflective surfaces such as mirrors, polished metal, glass or polished
ceramics to avoid uncontrolled beam reflection or scattering. All instruments used with the Laser
system should have brushed, burnished, or blackened non-reflective surfaces.
Clinician and patient must use appropriate eye and skin protection. All personnel in the immediate area of laser use must wear eye
protection specifically rated for CO
2
Lasers (OD 4+). Failure to do so may result in serious and permanent damage to the eyes.
