Risk Information – The VenaCure EVLT System

Important Risk Information

VENACURE 1470 PRO LASER INDICATION FOR USE

Indications for Use: The VenaCure 1470 Pro laser is intended 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.

Warnings:

This device is not intended to be used in MR environment.
Restrict Access to the working area.
All the personnel present in the laser working area must wear all the protective devices.
Openings inside installation area that are transparent to laser radiation must be properly darkened.
All operators should become familiar with all the requirements for safe use of the medical laser systems as described in CAN/CSA- Z386-14 (Safe use of lasers in health care).
Mobile phones and similar electrical devices must be switched off when the laser device is working.
To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. The Device shall be installed and used in compliance with the national or local requirements in place in your country.
Do not wrap the footswitch with any plastic (or other material) film or cover bag, unless authorized by the manufacturer. The unauthorized use of wrapping bags/films may block the pedal in pressed position and cause unwanted laser emission.
If optical fiber is hardly bent or improperly secured, it can lead to damage the fiber and/or harm to the patient or user!
For proper use, refer to the Instruction for Use for VenaCure EVLT procedure kits.
When selecting a pre-set program, it is a Physician responsibility to check and verify the eligibility of the laser output parameters to the treatment of interest and, in case, to adjust them before proceeding.
As with any conventional surgical operations, adverse reactions may occur following treatment. Use cautiously with patients who have had difficulty with previous laser procedures.
This operation shall be performed with the device switched off and disconnected from the mains.
Use of controls, adjustments or demonstration of procedures other than those specified herein may result in hazardous radiation exposure.

Potential Complications:

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.

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

VENACURE EVLT 1470 LASER INDICATIONS FOR USE

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.

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 mains 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:

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

VENACURE EVLT NEVERTOUCH PROCEDURE KITS, NT DIRECT PROCEDURE KITS, AND THE VENACURE EVLT TRE' SHEATH INDICATIONS FOR USE

Indications for Use: The VenaCure EVLT NeverTouch Procedure Kits, VenaCure EVLT NeverTouch Direct Procedure Kits and the VenaCure EVLT Tre’ Sheath are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremities.

This product should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limbs.

Warnings:

Treatment of a vein located close to the skin surface may result in skin burn.
Paresthesia may occur from thermal damage to adjacent sensory nerves.
Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy. Use appropriate eye and protective wear for both patient and operating personnel.
Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient.
Reprocessing may compromise the integrity of the device and/or lead to device failure.

Potential Complications:

Refer to Instructions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Potential Complications and Contraindications prior to use of the product.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

VENACURE EVLT 400 μm PERFORATOR AND ACCESSORY VEIN ABLATION KIT INDICATIONS FOR USE

Indications for Use: The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities.

The VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for treatment of incompetent (i.e. refluxing) perforator veins (IPVs).

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. Patients with an inability to ambulate. Patients with deep vein thrombosis (DVT). Patients who are pregnant or breast feeding. Patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment.

Extremely tortuous vein segments may require treatment by alternative techniques (phlebectomy, sclerotherapy).

Warnings:

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
Treatment of a vein located close to the skin surface may result in a skin burn.
Paresthesia may occur from thermal damage to adjacent sensory nerves.
Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for any person present in the operating room.
Prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending. Do not coil the fiber tighter than a radius of 60 mm.
The positions of the Site Marks on the EVLT fiber have been matched to the introducer sheath provided in the VenaCure EVLT 400 μm Perforator and Accessory Vein Ablation Kit. Alternative sheaths must not be substituted.
Do not tighten the compression clamp on sheath until fiber is in position.
Laser protective eye wear must be worn by everyone in the treatment room including the patient.

Adverse Events:

Potential complications include, but are not limited to the following: DEHP Exposure, Deep Venous Thrombus, Hematoma, Hemorrhage, Infection, Necrosis, Neovascularization, Non-Target Irradiation, Paresthesia, Phlebitis, Pulmonary Embolism, Skin Burns and Pain, Infection, Skin Pigmentation Alteration, Thrombophlebitis, Thrombosis, and Vessel Perforation.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

VenaCure EVLT OPS Procedure Kits Indications for Use

Indications for Use: The VenaCure EVLT OPS Procedure Kits are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.

Warnings:

Contents supplied STERILE using an ethylene oxide (EO) process.
Do not use if sterile barrier is damaged. If damage is found, call your sales representative.
Inspect prior to use to verify that no damage has occurred during shipping.
For single patient use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
Treatment of a vein located close to the skin surface may result in a skin burn.
Paresthesia may occur from thermal damage to adjacent sensory nerves.
Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for any person present in the operating room.
Reuse of single-use devices creates a potential risk of patient or user infections.
Contamination of the device may lead to injury, illness or death of the patient.
Reprocessing may compromise the integrity of the device and / or lead to device failure.
Laser protective eyewear must be worn by everyone in the treatment room.
Instruct the patient to avoid hot baths and vigorous activity for 7 days following VenaCure EVLT.

Adverse Events:

Potential complications include, but are not limited to the following: Hematoma, Infection, Paresthesia, Phlebitis, Pulmonary Embolism, Skin Burns, Thrombophlebitis, Thrombosis, and Vessel Perforation.
Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

VENACURE EVLT PROCEDURE PACKS

CAUTION: Federal (USA) law restricts the sale of these devices by or on the order of a physician.