Important Safety Information

ClosureFast Catheter:

Intended Use/Indications:  The ClosureFast endovenous radiofrequency ablation (RFA) catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.  The catheter is provided sterile, and is a single-use, disposable device. These catheters cannot be adequately cleaned and /or sterilized by the user in order to facilitate safe reuse, and is therefore intended for single use. Attempts to clean or sterilize these devices may result in a bio-incompatibility, infection or product failure risks to the patient.

Contraindications:  The ClosureFast catheter is contraindicated for use in patients with thrombus in vein segment to be treated.  No data exists regarding the use of this catheter in patients with documented peripheral arterial disease.  The same care should be taken in the treatment of patients with significant peripheral arterial disease as would be taken with a traditional vein ligation and stripping procedure.

 Potential Complications:

The potential complications include, but are not limited to, the following:

Adjacent nerve injury

Hematoma

Pulmonary embolism

Thrombosis

Infection

Phlebitis

Skin burn or discoloration

Vessel perforation

Warnings:

  • Treatment of a vein located near the skin surface may result in skin burn in the skin is not protected with fluid infiltration.
  • Nerve injury may occur from thermal damage to adjacent sensory nerves. Risk of nerve injury may be higher with treatment at or below the calf, or without perivenous fluid infiltration.

Precautions:

  • Do not bend catheter into a tight radius. Kinking of the shaft may damage the catheter.
  • To prevent damage to the guidewire, ensure that the guidewire does not protrude from catheter tip when inserting catheter into vein.
  • The vein wall may be thinner in an aneurysmal segment. To effectively occlude a veing with an aneurysmal segment, additional tumescent infiltration may be needed over the aneurysmal segment, and the treatment of the vein should include segments proximal and distal to the aneurysmal segment.

 

ClosureRFS Endovenous Radiofrequency Stylet:

Intended Use/Indications:  The ClosureRFS stylet is intended for use in vessel and tissue coagulation including treatment of incompetent (i.e. refluxing) perforator and tributary veins.

Contraindications:  The ClosureFast catheter is contraindicated for use in patients with thrombus in vein segment to be treated.  For patients with a pacemaker, internal defibrillator or other active implanted device, consult the cardiologist and the manufacturer of the active implantable device. Continuous patient monitoring during the procedure is recommended.  Evaluate the patient and the implanted active device post-procedure.  Keep all power cords and the instrument cable away from the location of the pacemaker or leads, defibrillator or the implanted active device.

No data exists regarding the use of this catheter in patients with documented peripheral arterial disease.  The same care should be taken in the treatment of patients with significant peripheral arterial disease as would be taken with a traditional vein ligation and stripping procedure.

 Potential Complications:

The potential complications include, but are not limited to, the following:

Arteriovenous fistula

Infection

Phlebitis

Skin burns

Hematoma

Nerve damage

Pulmonary embolism

Thrombosis

Warnings:

  • Treatment of a vessel located near the skin surface may result in a skin burn.
  • Nerve injury may occur from thermal damage to adjacent nerves. Risk of nerve injury is higher with treatment at or below the knee.

Precautions:

  • Do not use device if package is opened or damaged, as sterility cannot be guaranteed.
  • To avoid kinking, do not bend device shaft.
  • Do not advance device and/or guidewire against endovascular resistance.
  • Use the ClosureRFS stylet only with a ClosureRFG radiofrequency generator.

 

ClosureRFG RF Generator Service Manual (RFG2):

Intended Use/Indications:  The RF generator is inteneded for use in the electromagnetic environment specified below.  The customer or the user of the RF generator should assure that it is used in such an environment.

 

Emissions test Compliance Electromagnetic environment- guidance
RF emissionsCISPR11 Group 2 The RFG2 must emit electro-magnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.
RF emissionsCISPR11 Class A The RFG is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies building used for domestic purposes
Harmonic emissionsIEC61000-3-2 Class
Voltage fluctuations/flicker emissions IEC 61000-3-3 Complies

Contraindications:  NA

Potential Complications:  NA

Precautions/Operations Warnings and Cautions:

  • The AC Power Switch in the OFF position isolates the RF generator electrically from the supply mains on all poles simultaneously
  • Using a power cord that does not meet the specifications in the Service Manual may present a potential for an electric shock or affect the performance of the RF generator
  • The AC Power Switch on the rear panel serves as the means of disconnection from supply mains.

 

ClosureRFG Radiofrequency Generator Operation Manual (RFG3):

Intended Use: The ClosureRFG radiofrequency generator supplies, measures, and displays RF output power, load impedance (ClosureRFS only), and elapsed time of RF delivery.  The ClosureRFG generator also interfaces with a sensor in the catheter to provide a continuous display of measured temperature during RF delivery.

 Indications for Use:  The Closure RFG generator is used with radiofrequency catheters intended for vessel and tissue coagulation.

Contraindications:  NA

Potential Complications:  NA

Warnings:

Do not wrap the catheter cable around metal objects, as this might induce hazardous currents into the patient

The ClosureRFG generator requires special precautions regarding Electromagentic Compliance and needs to be installed and put into servicing according to Electromagentic Compiance (EMC) on page 11-4

ClosureRFG generator failure could result in an unintended increase in RF output.

Use of electrosurgery could result in neuromuscular stimulation resulting in patient injury

Electrodes and probes for monitoring, stimulation, and imaging devices can provide paths for high-frequency current even if batter powered, insulated, or isolated at line frequency.  The risk of burns can be reduced, but not eliminated, by placing these electrodes or probes as far away from the ablation site as possible.  Protective impedance incorporated into monitoring leads may further reduce the risk of burns and permit continuous monitoring during RF energy deliver, Do not use needed as monitoring electrodes during procedures.

Caution:

To prevent injury to the patient, do not start RF power until the catheter is properly positioned in the patient.

RF power activation tones and lights are important safety features. Do not obstruct indicator lights or the screen.  Do not disable auditory tones.

The ClosureRFG generator should not be used adjacent to or stacked with other equipment.  IF adjacent use is necessary, the ClosureRFG generator should be observed to verify normal operation in the configuration in which it will be used.

Do not plug a wet catheter connector into a receptacle as it may damage the ClosureRFG generator.