L-1670 Rev 0
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© OmniGuide, Inc.
The BEACON Advanced Energy Laser System device can be used only by trained medical
professionals on general population of the patients. Applicability of the BEACON Advanced
Energy Laser System to treatment of the patient is determined by a qualified physician
based on the patient’s medical history within cleared indications for use.
Note: For fiber and laser accessories Indications for Use, see applicable fiber or laser accessories Instructions
for Use. The Laser has been tested to the European Standards and Regulations, carrying the CE Mark affixed to
the product. Information about the Management System can be obtained from the manufacturer.
Note: This product is not intended for neurosurgical/neurotology use in CE Mark recognized European
Countries. Accessories used with articulating arm (e.g. micromanipulators and handpieces) comply
with their respective regulatory requirements such as 510(k) and CE marking.
Note: This product is not intended for direct contact with the patient. Only fibers or laser accessories attached
to the laser may contact the patient. Fiber and laser accessories are classified as applied part, type B.
Notice Concerning Warranty
Operating or handling of this medical laser, inconsistent with this manual, may void the warranty.
4.0 WARNING, CAUTION AND SYMBOLS
Contraindications
Do not use OmniGuide Laser System if the medical history of the patient is not compatible with laser treatment.
Adverse Effects
Potential complications could include:
•
The general complications related to surgical procedures, such as local and systemic infections
•
Thermal tissue damage
•
Perforation of tissue or tissue adherence related to misuse of the device.
•
Laser surgical procedures should be performed only by a licensed healthcare
practitioner adequately trained to, and familiar with such surgical techniques
and clinical use of CO
2
lasers, and hazards associated with it.
•
Usage of gas can increase the chance of gas embolism, see
OmniGuide fiber IFUs for additional information
Definition of Warning
Warning is the term used to alert the user to possible injury, death, or other
serious adverse reactions associated with the use or misuse of the device. Warning
statements are placed at the appropriate sections of this User Manual.
Definition of Caution
Caution is the term used to alert the user of the possibility of a problem with the device associated
with its use or misuse. Such problems include device malfunctions or device failure and may result
in minor or moderate injury to the user and/or patient, damage to the device, or damage to
other property. Caution statements appear at the appropriate sections of this User Manual.