Benefits

• Streamlined form factor fits the modern practice environment—and it’s compact enough to transport between hospital and office.
• Intuitive touchscreen controls and custom treatment parameters.
• Preset capability enables quick and easy laser adjustments to suit individual preferences in multiple-practitioner practices and treatment types.

As a water-specific laser, the VenaCure 1470 Pro laser targets water as the chromophore to absorb the laser energy. Since the vein structure is mostly water, it is theorized that the 1470 nm laser wavelength efficiently heats endothelial cells with a low risk of collateral damage, resulting in an optimal vein ablation 1.

It is designed to work exclusively with the range of AngioDynamics fibers, including the NeverTouch* fibers. Maximizing these two technologies can result in even better patient outcomes1. The 1470 nm laser allows effective vein ablation with the targeted energy of 30-50 joules/cm at a setting of 5-7 watts.

Indications for Use:

The VenaCure EVLT 1470 Laser is indicated for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.

Contraindications: Contraindications include but are not limited to the following, Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated.

Patients with peripheral arterial disease as determined by an Ankle-Brachial Index < 0.9.

Warnings:

• No modification of this equipment is allowed.
• Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
• Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided.
• A Class 4 (IV) Laser is hazardous to the eye from the direct beam and diffuse reflections. It also presents significant skin and fire hazard.
• Avoid eye or skin exposure to direct or scattered radiation. Take all necessary protective measures, as explained in the rest of this section, in areas where the laser is being used.
• The aiming beam is a Class 3R (IIIa) laser and an unprotected eye may view the beam scattered from a non-reflective surface. Do not stare into the aiming beam or view it directly with optical instruments.
• Avoid directing the laser beam anywhere other than the treatment area or calibration ports.
• Before using a fiber, check it carefully for any signs of damage during storage or transit. Protective caps should be in place over SMA connectors. All screws and ports should be secure. Do not use if there is any sign of damage.
• There are no user serviceable parts in the VenaCure 1470 laser. The exterior cover should only be removed by a trained and authorized laser service technician.
• To avoid the risk of electric shock, the equipment must only be connected to a supply main with protective earth.
• Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
• Always switch off the VenaCure 1470 laser at the rear power switch and disconnect the electrical power cord from the AC supply before performing any of the cleaning or maintenance procedures described below.
• Extreme caution should be taken when operating the VenaCure 1470 near the eyes.
• All personnel must wear approved protective glasses to reduce the risk of eye damage. The patient should wear protective glasses.
• The local Laser Safety Officer should review all procedures for safety prior to system use.
• All protective glasses should be designed for protection from continuous wave laser radiation in the wavelength range 1440 – 1500 nm.
• The degree of optical filtration (Optical Density or OD) depends on the application and should be assessed and approved by the appointed Laser Safety Officer for the establishment.
• The recommendations of European Standards EN 60825-1 or EN 207 are appropriate to assessing laser eye risk. Note that the standards assume a viewing distance from the source of light of more than 100 mm (4 inches).
• AngioDynamics supplies laser safety glasses marked in accordance with EN 207 as L3 or greater. Contact your local AngioDynamics representative if these are required.
• The ‘Nominal Ocular Hazard Distance’ is 0.31 m (1 foot).
• Use of optical accessories and viewing aids, which may increase the eye exposure beyond a safe limit, should be subject to the approval of the Laser Safety Officer.
• Never look directly into the laser aperture even if wearing safety glasses. Serious eye injury could result.
• Irradiation of any substance or material other than the target treatment of varicose veins and varicosities may result in a laser burn.
• Avoid placing reflective materials such as glass, metals and polished plastic in the beam.
• The VenaCure 1470 laser is not intended for use in oxygen-rich environments. Do not use flammable or explosive anesthetic gases that may be ignited by the laser as the VenaCure 1470 laser is not protected against hazards of ignition of flammable anaesthetic mixtures.
• As with any conventional surgical operations, adverse reactions may occur following treatment.
• Use cautiously with patients who have had difficulty with previous laser procedures.

Potential complications include, but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory nerves, anesthetic tumescence, non-target irradiation, hemorrhage, necrosis, DEHP exposure, skin burns and pain.