Boston Scientific

TCN-xx-x Electrodes Instructions for Use

3 Pages

Cosman TCN ELECTRODE INSTRUCTIONS FOR USE DESCRIPTION The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain. The 5 cm, 10 cm, 15 cm, and 20 cm length thermocouple electrodes are each inserted through the commercially available Radiofrequency (RF) disposable Cannula from Boston Scientific, which are color coded based on length: 5 cm (white), 10 cm (blue), 15 cm (yellow), 20 cm (green). The TC connecting cable (CB112-TC) is used to connect the thermocouple electrode to a Cosman RF Generator to stimulate, lesion, and monitor the impedance and temperature of the treatment site. A ground pad is required for stimulation and lesioning using TCN Electrodes. Contact your local Boston Scientific sales support team for other available components and replacement parts. The G4-CO is a cable organizer that consists of plastic hook and loop fastener material with multiple locking tabs and alligator clips at both ends for securing to patient drapes or linens. Each locking tab has an identifying character for easy association with a generator connection port. MODEL NUMBERS The following products are designed for use with the Cosman RF generators: Model Number TCN-5 TCN-10 TCN-15 TCN-20 TCN-5-3M TCN-10-3M TCN-15-3M TCN-20-3M CB112-TC TCN-CASE RFG-1A RFG-1B RFG-4 Cannula* Ground Pad*  Product Nitinol Thermocouple Electrode, 5 cm Nitinol Thermocouple Electrode, 10 cm Nitinol Thermocouple Electrode, 15 cm Nitinol Thermocouple Electrode, 20 cm TCN Thermocouple Electrode, 5 cm, 3m Cable TCN Thermocouple Electrode, 10 cm, 3m Cable TCN Thermocouple Electrode, 15 cm, 3m Cable TCN Thermocouple Electrode, 20 cm, 3m Cable Compatible Products Thermocouple Electrode Connecting Cable Sterilization Case RFG-1A Radiofrequency Generator RFG-1B Radiofrequency Generator RFG-4 Radiofrequency Generator Disposable Cannula Ground Pad  *For a complete list of compatible Cannulas and ground pads, contact your local Boston Scientific sales support team. INDICATIONS The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only. WARNINGS Use only the ground pads provided by Boston Scientific. Failure to do so may result in patient injury or damage to the product. For a patient with a cardiac pacemaker, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the RF procedure. When the pacemaker is in the sensing mode, it may interpret the RF signal as a heartbeat and may fail to pace the heart. These devices are not intended to be used in an MRI environment and have not been evaluated for safety in an MRI environment. Electrodes and probes of monitoring, stimulating, and patient contacting imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the  patient simultaneously with this RF Generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer. Do not modify this product, as modification could result in a safety hazard. Do not interchange components from different electrode kits. Using the wrong component can result in serious patient injury. Do not use a needle as a dispersive electrode since a needle may cause skin burns at the reference site due to high current densities. Prior to use, visually inspect the electrode for damage or contamination. If the electrode is damaged please contact Boston Scientific customer support team. If the electrode is contaminated, clean and sterilize per the instructions below. Magnification may be necessary for proper visual inspection. Users must adhere to universal precautions when handling or using this device to prevent transmission of diseases. PRECAUTIONS Do not use if the electrode is defective or damaged. Discontinue use and contact the Boston Scientific customer support team for further assistance. ADVERSE EVENTS Risks associated with use of TCN Electrodes for the ablation of peripheral nerve tissue include but are not limited to: ▪ Allergic reactions ▪ Unintentional burns ▪ Bleeding ▪ Device failure ▪ Increased pain ▪ Infection ▪ Need for additional treatment ▪ Nerve injury ▪ Paralysis ▪ Tissue/visceral injury ▪ Death SPECIAL HANDLING Do not sharply bend, kink, or stress the TCN Electrode. Avoid draping the electrode over sharp edges. BEFORE YOU BEGIN Please read all information carefully prior to using the electrodes, particularly the Operator’s Manual provided with the Cosman RF Generator. Use only electrodes and accessories supplied by Boston Scientific with the Cosman RF Generator. Because there is a potential hazard of nerve injury, only physicians well trained in RF procedures should use this technique. This product is not provided sterile and requires sterilization prior to use. Ensure that you complete the cleaning and sterilization procedure below. CLEANING AND STERILIZATION INSTRUCTIONS It is important to always inspect the electrode and perform the entire cleaning and sterilization process between uses. Cleaning and sterilization should be performed prior to initial use and before every subsequent use. Users must adhere to universal precautions when handling or using this device. Remove the stainless steel protective sleeve from the electrode prior to cleaning. Visually inspect the electrode and contact the Boston Scientific customer support team if damaged. Magnification may be necessary for proper visual inspection. 1.  Put on gloves and other personal protective equipment.  2.  Prepare a mild enzymatic detergent with a near neutral pH (e.g., Steris Prolystica® 2X Concentrate Enzymatic Presoak and Cleaner) following the instructions provided by the manufacturer. 92154327-01 Content: 92217413 REV C Page 1 of 3  Production  TCN Electrode IFU EN-OUS Boston Scientific Confidential. Unauthorized use is prohibited.  92217413 C.2 Page 1 of 3
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