CONTRAINDICATIONS:
Patients should not have their varicosities ablated who have the following conditions: thrombus in the vein segment to be treated; aneurysmal section in the vein segment to be treated; peripheral artery disease as determined by Ankle Brachial Pressure Index with a value of <0.9; an inability to ambulate; deep vein thrombosis; pregnant or breast-feeding; or patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment.
WARNINGS AND PRECAUTIONS:
Read the Instructions For Use and the Laser Operator’s manual thoroughly prior to using the VenaCure EVLT Procedure Kits with the 400 micron Fiber. Observe all warnings, precautions and cautions noted. Failure to do so may result in patient complications. Laser protective eyewear must be worn by everyone in the treatment room, including the patient.
CAUTION:
Intended for use only by fully trained physicians. Federal (USA) law restricts these devices to sale by or on the order of a physician. The VenaCure EVLT Procedure Kit is intended for single patient use only. Inspect the sealed packages before opening. If seals are broken or the packages are damaged, treat as non-sterile and discard. Ensure expiration dates are still valid. Treatment of a vein located close to the skin surface may result in a skin burn. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy.