RF3000™ Radiofrequency Ablation System

Radiofrequency Ablation

Indications, Safety, and Warnings

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Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

RF3000 Radio Frequency Generator

The RF 3000 Radio Frequency (RF) Generator is intended for thermal coagulation of soft tissue with electrodes separately cleared by the United States FDA. The generator delivers an isolated RF output of up to 200 watts to the electrode. Full power is available in the impedance range of 25Ω to 100Ω at a constant RF voltage; lower powers are available outside this range. Power can be adjusted manually; however, changes in load impedance will change the actual power delivered (a safety feature described more fully in “Passive Power Limitation”). When power is on, actual delivered RF power and impedance are displayed. The Operation and Service Manual is intended as an instructional guide only.

General Procedure Safety

WARNING! Safe and effective electrosurgery is dependent not only on equipment design, but also, to a large extent, on factors under the control of the operator. It is important that the instructions supplied, both with this equipment and the accessories, be read, understood, and followed in order to ensure safety and effectiveness.

WARNING! No modification of this equipment is allowed

WARNING! The use of RF energy can produce unintended neuromuscular stimulation.

Electromagnetic Interference

WARNING! The use of electrosurgical devices can cause electromagnetic interference (EMI) in other devices, particularly cardiac pacemakers. Precautions should be taken to ensure that the patient’s well-being is maintained in the event of such interference.

WARNING! The use and proper placement of dispersive electrodes (return pads) is a key element in the safe and effective use of monopolar electrosurgery, particularly in the prevention of burns. Follow the manufacturer’s Instructions for Use.

LeVeen Needle Electrode Family

INTENDED USE/INDICATIONS FOR USE

The LeVeen Needle Electrode Family is intended to be used in conjunction with the RF 3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions. These procedures should only be performed by physicians and staff familiar with the equipment and techniques involved.

PRECAUTION

Before using, inspect the package for any breach to the sterile barrier and inspect product for any damage. If package is broken or product is damaged DO NOT USE. Immediately return package and product to Boston Scientific.

WARNINGS

  • The colored insulated cannula must be used at all times when accessing tissue. Use of the electrode without the colored insulated cannula may result in serious burns to the patient and/or user.
  • Damage to the insulation of the introducer may result in serious burns to the patient and/or user.
  • Precaution: The LeVeen Needle Electrode Family must be used in conjunction with the Boston Scientific RF 3000 ™ Generator.
  • For patients with permanent pacemakers and Implantable Cardiac Defibrillators (ICD) additional precautions should be taken.

ADVERSE EVENTS

Reported complications associated with radiofrequency (RF) ablation of liver tissue include, but are not limited to:

  • Abscess
  • ARDS (Acute Respiratory Distress Syndrome)
  • Arrhythmia
  • Ascites
  • Biloma
  • Burn
  • Death
  • Delayed hemorrhage into ablated tissue
  • Diarrhea
  • Electric Shock
  • Fistula, including biliary fistula
  • Hematoma
  • Hemorrhage
  • Infection
  • Liver Failure
  • Liver Insufficiency
  • Pain
  • Perforation
  • Peritonitis
  • Persistent Fever > 39° C
  • Pleural Effusion
  • Renal Failure
  • Tumor Recurrence
  • Tumor Seeding

Soloist Single Needle Electrode

INTENDED USE/INDICATIONS FOR USE

The Soloist Single Needle Electrode is intended to be used in conjunction with the RF 3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

CONTRAINDICATIONS

None known.

WARNINGS

  • Damage to the insulation of the introducer or needle may result in serious burns to the patient and/or user.
  • Precaution: The Soloist™ Single Needle Electrode must be used in conjunction with the Boston Scientific RF 3000™ Generator.
  • For patients with permanent pacemakers and Implantable Cardiac Defibrillators (ICD) additional precautions should be taken.

ADVERSE EVENTS

Reported complications associated with radiofrequency (RF) ablation of liver tissue include, but are not limited to:

  • Abscess
  • ARDS (Acute Respiratory Distress Syndrome)
  • Arrhythmia
  • Ascites
  • Biloma
  • Burn
  • Death
  • Delayed hemorrhage into ablated tissue
  • Diarrhea
  • Electric Shock
  • Fistula, including biliary fistula
  • Hematoma
  • Hemorrhage
  • Infection
  • Liver Failure
  • Liver Insufficiency
  • Pain
  • Perforation
  • Peritonitis
  • Persistent Fever > 39°C
  • Pleural Effusion
  • Renal Failure
  • Tumor Recurrence
  • Tumor Seeding
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