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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
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Cosman TCN ELECTRODE 3.
Carefully clean all pieces of the electrode, including the stainless steel protective sleeve, with a mild enzymatic cleaner using a soft sponge or lint-free cloth before sterilization. Follow the enzymatic cleaner manufacturer instructions. Use caution to keep moisture out of the cable connectors.
3.
Connect the TCN Electrode to the CB112-TC cable and if necessary a G4-CO cable organizer. Plug the cable into the active output jack of the Cosman RF Generator. Only use the TCN Electrodes with an approved RF generator.
4.
With the stylet in the Cannula, insert the appropriate Cannula into the patient with fluoroscopic guidance. The physician determines the appropriate depth of insertion. Remove the stylet from the Cannula and insert the electrode down the shaft of the Cannula. The electrode tip must be located within the exposed tip of the Cannula. Before lesioning, ensure the electrode is fully inserted in the Cannula. Only use an electrode that has the same length as the RF Cannula.
5.
Confirm the final position of the electrode tip using electrical stimulation. Pay attention to involuntary movements of relevant muscles that may be induced by electric stimulation. Possible misplacements are indicated by inadequate patient responses. Readjust the Cannula and electrode as needed. Proper electrode placement should be verified using anatomical landmarks, sensory stimulation techniques, fluoroscopic guidance, impedance reading, and good clinical judgment before RF lesion making procedures are initiated. Adjust the output of the generator as low as possible when performing electrical stimulation.
6.
After the position of the electrode has been verified, remove the electrode from the Cannula. Inject local anesthesia at the luer hub of the cannula. Reinsert the electrode. The patient is now ready for RF lesioning.
10. Place the electrode into the Cosman sterilization case and double wrap the sterilization case.
7.
Note: These devices have been validated for use with the wrapped Cosman sterilization case. It is the responsibility of the user to validate other sterilization configurations.
The electrode and Cannula are delicate due to their small diameter shaft. Do not modify, bend, kink, or stress the shafts of the electrode or Cannula.
8.
Recording RF voltage, current, impedance, power and tip temperature is recommended for each procedure since it gives the physician a measure of parameter normalcy for a given procedure and electrode size. Any observed anomaly of high or low voltage, currents, impedance or power will be apparent and signal possible problems.
9.
Discontinue use if erratic or sluggish temperature readings are observed, which may indicate a faulty cable connection, broken temperature sensor of the electrode, or loss of RF power into an undesired location such as implanted hardware.
Note: For difficult areas, using a clean soft surgical instrument brush is recommended. 4.
Thoroughly rinse all items under clean, deionized water until all detergent or chemical residue is no longer visible. Use caution to keep moisture out of the cable connectors.
5.
Dry any excess moisture by gently wiping the outside of the electrode with a clean, dry, lint-free cloth.
6.
Inspect for any residual debris and repeat cleaning until there is no visual sign of residual debris. Do not use if the electrode is damaged.
7.
Place the metal protective sleeve on the electrode.
8.
Carefully clean the sterilization case (TCN-CASE) with a mild enzymatic cleaner using a soft sponge or cloth before sterilization. After cleaning, the sterilization case should be thoroughly rinsed in clean water to remove any detergent or chemical residue before sterilization.
9.
Dry any excess moisture by gently wiping the sterilization case with a clean, dry, lint-free cloth.
11. Place the wrapped electrode sterilization case into the Dynamic Air Removal Steam Sterilizer (Prevacuum Sterilizer). Note: Hospital facilities must validate process parameters per their sterilization equipment and intended load configuration. Boston Scientific recommends steam autoclave for all electrode cables. Boston Scientific has verified product performance in the following cycle: Dynamic Air Removal Steam Sterilizer. Wrapped Cosman electrode sterilization case should be exposed to 132C (270F) for four minutes.
10. Wipe impurities from product with an isopropyl alcohol pad immediately after use.
12. Dry any excess moisture FOR 20 MINUTES before use. Do not use heated drying cycle in excess of 132C (270F).
11. Perform CLEANING AND STERILIZATION INSTRUCTIONS contained within this document.
13. Discard used gloves.
RE-USE The TCN Electrode has been validated to 20 sterilization cycles. The useful life depends on usage frequency, the care with which it has been handled and respect of preparatory procedures. Careful inspection, functional testing and usage tracking of the electrode before use is the best method of determining the end of serviceable life for the medical device. The user is responsible for checking the TCN Electrode before each use; the use of soiled or damaged electrodes is at the user’s own risk.
OPERATING INSTRUCTIONS Prior to use, ensure that you have visually inspected the electrode for damage or contamination. Magnification may be necessary for proper visual inspection. Do not use if the electrode is damaged. Please contact Boston Scientific customer support team if damaged. If the electrode is contaminated, sterilize per the CLEANING AND STERILIZATION INSTRUCTIONS. 1.
Position the patient on a radiographic table as necessary for the intended procedure.
2.
Place a Cosman Ground Pad (minimum 110 cm² conductive plate area) on the patient at the appropriate site, depending on the procedure, and plug the connector into the black reference jack on the generator. A ground pad must be used to create a closed electrical circuit. Without the ground pad, the electrode monitors temperature but does not stimulate or lesion. Care should be taken to maximize the surface area of the dispersive electrode. The dispersive electrode should be reliably attached with its entire surface area against the patient’s body and as close to the operating field as possible.
For the purpose of tracking the number of reprocessing cycles, it is recommended that the user document the lot number and tracking number of the TCN Electrode to verify the amount of times the electrode has been reprocessed. The lot number and tracking number (T/N) are physically marked on the device. The lot number features a (10) and is followed by an eight digit number as marked on the device. The tracking number is denoted by T/N: followed by a three digit number as marked on the device.
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Cosman TCN ELECTRODE GUIDE TO SYMBOLS: Symbol
Definition
Symbol
Definition
Lot Number
QTY
Quantity
Catalog Number
Caution, consult accompanying documents
Do not use if package is damaged.
Operating Instructions
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
CE Marked Product
Date of Manufacture
Non-Sterile
EU Authorized Representative: Boston Scientific Limited Ballybrit Business Park Galway, Ireland T: +33 (0) 1 39 30 97 00 F: +33 (0) 1 39 30 97 99
Legal Manufacturer: Boston Scientific Neuromodulation Corporation 25155 Rye Canyon Loop Valencia, CA 91355 USA (866) 789-5899 in US and Canada (661) 949-4000, (661) 949-4022 Fax (866) 789-6364 TTY www.bostonscientific.com Email: [email protected]
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Production
TCN Electrode IFU EN-OUS Boston Scientific Confidential. Unauthorized use is prohibited.
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