For safe use of the ACCURIAN™ RF Ablation System, the physician should have specific training, experience, and thorough familiarity with the use and application of this product.
DESCRIPTION
The Generator is a four-channel radiofrequency ablation platform that allows monopolar deliveries with a dispersive electrode as well as bipolar deliveries between probes. RF energy is applied to the patient according to the configured settings to create lesions in tissue. The generator is capable of stimulating nerve cells by delivering low frequency stimulation pulses. It is nonsterile and reusable.
INDICATIONS
The ACCURIAN™ RF Generator is intended for the creation of radiofrequency lesions in nervous tissue.
CONTRAINDICATIONS
Use of the ACCURIAN™ RF Ablation System is contraindicated in patients with systemic infection or local infection in the area of the procedure.
WARNINGS
DO NOT USE in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified professional (e.g., cardiologist). A possible hazard exists because interference with the action of the electronic implant may occur, or the implant may be damaged. Check the compatibility and safety of combinations of other physiological monitoring and electrical apparatus to be used on the patient while operating the ACCURIAN™ RF Ablation System. If the patient has a spinal cord, deep brain, or other stimulator, contact the manufacturer to determine if the stimulator needs to be in the OFF position. The procedure is to be performed with minimal to moderate sedation to allow the patient to remain in a communicative state for patient feedback; general anesthesia is not recommended. Adequate measures must be taken to minimize x-ray exposure while using fluoroscopy. This exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects. Do not modify the equipment as this may compromise safety and efficacy. When the ACCURIAN™ RF Generator is activated, electrical fields may interfere with other electrical medical equipment. Ablation must be performed under fluoroscopic or ultrasonic guidance. Do not perform ablation without imaging as it can result in severe injury to the patient. Observe appropriate fire and electrical cautions at all times when system is in use.
ADVERSE EVENTS
As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury can occur. Nerve injury including thermal injury, or puncture of the spinal cord or nerve roots potentially results in radiculopathy, paresis, and paralysis. Potential complications include but are not limited to: infection including deep or superficial wound infection, bleeding, nerve damage, visceral injury, increased pain, pulmonary embolism, hemothorax or pneumothorax, hemorrhage, and hematoma.
For a complete description of the Warnings, Precautions, and possible Adverse Events associated with the ACCURIAN™ RF Ablation System, please see the following User Manuals: ACCURIAN™ Connector Hub, ACCURIAN™ Enhanced RF Probe Kit, ACCURIAN™ Pump Unit and ACCURIAN™ Pump Cable, ACCURIAN™ RF Cannula, ACCURIAN™ Radiofrequency Generator, ACCURIAN™ Reusable RF Probe, and ACCURIAN™ Single-Use RF Probe.