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Cosman CSK TC Electrode INSTRUCTIONS FOR USE DESCRIPTION The Cosman Medical CSK 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 length (green). The TC connecting cable 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 CSK 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
Product
CSK-TC5 CSK-TC10 CSK-TC15 CSK-TC20 CSK-TC5-3M CSK-TC10-3M CSK-TC15-3M
CSK TC Electrode, 5 cm long CSK TC Electrode, 10 cm long CSK TC Electrode, 15 cm long CSK TC Electrode, 20 cm long CSK TC Electrode, 5 cm with 3 m cable CSK TC Electrode, 10 cm with 3 m cable CSK TC Electrode, 15 cm with 3 m cable
CB112-TC CSK-CASE RFG-1A RFG-1B RFG-4 Cannula* DGP-PM/DGP-PMC**
Thermocouple Electrode Connecting Cable Sterilizable Case RFG-1A Radiofrequency Generator RFG-1B Radiofrequency Generator RFG-4 Radiofrequency Generator Disposable Cannula Ground Pad
Compatible Products
*For a complete list of compatible Cannulas, contact your local Boston Scientific sales support team. **For a complete list of compatible ground pads, contact your local Boston Scientific sales support team. INDICATIONS The CSK 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 radiofrequency 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. Electrodes and probes of monitoring, stimulating, and 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. Discontinue use and contact the Boston Scientific customer support team for further assistance. ADVERSE EVENTS Risks associated with use of CSK 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 CSK Electrode. Avoid draping the electrode over sharp edges. BEFORE YOU BEGIN This product is not provided sterile and requires sterilization prior to use. Ensure that you complete the cleaning and sterilization procedure. INSTRUCTIONS Please read all information carefully prior to using the electrodes, particularly the Operator’s Manual provided with the Cosman RF Generator. Use only Cosman electrodes and accessories with the Cosman RF Generator. Only use a RF electrode compatible with the generator. Since there is a potential hazard of nerve injury, only physicians well trained in RF procedures should use this technique. 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 92227761-01 Content: 92227814 REV A Page 1 of 2
Production
CSK TC Electrode IFU EN Boston Scientific Confidential. Unauthorized use is prohibited.
92227814 A.1 Page 1 of 2
Cosman CSK TC Electrode attached with its entire surface area against the patient’s body and as close to the operating field as possible. 3. Connect the CSK Electrode to the CB112-TC cable and if necessary a G4-CO cable organizer. Plug cable into the active output jack of the Cosman RF Generator. Only use a RF electrode compatible with the 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 CSK Electrode down the shaft of the Cannula. Make sure the electrode tip lies within the exposed tip of the Cannula. Before lesioning, ensure the electrode is fully inserted in the Cannula. Only use a CSK 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. 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. Adjust the output of the generator as low as possible when performing electrical stimulation.
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
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]
7. 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. CLEANING AND STERILIZATION Carefully clean all pieces with a mild enzymatic cleaner using a soft sponge or cloth before sterilization. For difficult areas using a clean soft bristled brush is recommended. After cleaning, all items should be thoroughly rinsed in clean water to remove any detergent or chemical residue before sterilization. Use caution to keep moisture out of the cable connectors. Cosman recommends use of a mild enzymatic detergent with a near neutral pH. Cases and trays may be placed in mechanical cleaning equipment. Hospital facilities must validate process parameters per their sterilization equipment type and intended load configuration. Cosman recommends steam autoclave for all electrodes cables and cable organizer. Cosman has verified product performance in the following cycle: Prevacuum Sterilizer. Wrapped electrode cases should be exposed to 132C to 135C (270F to 275F) for at least 4 minutes. Dry before use. Do not use heated drying cycle. Disposal At the end of product life discard the product according to regional and national regulations for infectious materials/biohazard waste.
92227761-01 Content: 92227814 REV A Page 2 of 2
Production
CSK TC Electrode IFU EN Boston Scientific Confidential. Unauthorized use is prohibited.
92227814 A.1 Page 2 of 2