Electrode Probe Instructions for Use

ENGLISH/INSTRUCTIONS FOR USE

Electrode Probe READ ALL INFORMATION CAREFULLY BEFORE USING ATTENTION This informational brochure is to assist you in the usage of, and care for, the Electrode Probe. This is not an instructional reference to laparoscopic surgery. DEVICE DESCRIPTION Electrode Probes are monopolar (unipolar) electrosurgical cautery devices comprised of metal and plastic rated at a maximum of 2000 Vp. They are designed to cauterize, irrigate, and aspirate a laparoscopic surgical field when used in conjunction with Core Trumpet Hand Controls or Threaded Handle for Probe. Devices are 5mm x 32cm, have moveable sheaths and are available with the following tip designs: Spatula, L-Hook, J-Hook, and Needle. INTENDED USE Electrode Probes have applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures for cauterizing an endoscopic field and irrigation and aspiration at the surgical site. INSTRUCTIONS FOR USE 1. Thread the Electrode Probe into the Core Trumpet Hand Control or Threaded Handle for Probe. 2. Securely attach the Electrode Probe to the Hand Control to prevent leaking. 3. Attach a standard cautery cable to the monopolar (unipolar) cautery connector. Ensure a secure connection. Should eschar adherence occur, the electrode tips may be cleaned with an electrosurgical scratch pad. 4. This product is designed for non-continuous operation, with a duty cycle of 10 seconds ON, and 30 seconds OFF. 5. Devices supplied non-sterile must be sterilized prior to initial use to avoid contamination. Prior to subsequent re-use, devices are to be cleaned and sterilized to avoid cross-contamination. CLEANING 1. Remove Electrode Probe from irrigation and aspiration hand control or threaded handle. 2. Remove Sheath from Electrode Probe. 3. Use detergent mixed to manufacturer’s specification for cleaning. 4. Thoroughly scrub exteriors of products with a clean, soft brush dampened with detergent. 5. Thoroughly scrub interiors of products (as applicable) with a long cleaning brush or pipe cleaner dampened with detergent. 6. Clean product until able to visually verify soil removal. 7. Rinse product under running water to remove all traces of soap. 8. Rinse with distilled water. 9. Wipe product dry with lint-free towel. 10. Manipulate product to verify all visible surfaces are free of soil. If traces of soil are observed, repeat steps above. STERILIZATION The devices should be sterilized using an FDA cleared wrap indicated for these sterilization cycles.

Sterilization Cycle Configuration Minimum Temperature

Pre-Vacuum

Gravity

Wrapped

Wrapped

132 ºC/270 ºF

121 ºC/250 ºF

Cycle Time

4 minutes

15 minutes

Minimum Dry Time

10 minutes

10 minutes

After cleaning and sterilization, inspect the condition of O-ring where electrode connects to the hand controls/threaded handle. Also inspect the electrode sheath for damage. Contact a ConMed representative for replacement. CORE Laparoscopic instruments have been validated for twenty (20) steam sterilization cycles. The useful life span of a surgical instrument is largely dependent on the care and handling of the instrument. For optimal product life, protect the CORE instruments from contact with other instruments during decontamination and re-sterilization. Allow instruments to cool and dry prior to handling.

WARNINGS 1. 2.

Procedures for endoscopic surgery should be performed only by qualified and trained physicians familiar with endoscopic surgical technique. A thorough understanding of the principles and techniques involved in laparoscopic laser and electrosurgical procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other medical instruments. 3. Use only with electrosurgical units that comply with IEC 60601-1 Standards. Do not exceed the maximum electrical capacity of the device. Maximum Rated Voltage is 2000 Vp. 4. Always use the lowest possible setting to achieve the desired electrosurgical effect. 5. When electrosurgical instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility prior to initiation of the procedure and ensure that electrical insulation or grounding is not compromised. 6. Devices supplied non-sterile must be sterilized prior to initial use to avoid contamination. Prior to subsequent re-use, devices are to be cleaned and sterilized to avoid crosscontamination. 7. If any damage of Electrode Probe’s insulation is found, the instrument should not be used. 8. DO NOT modify or repair this device; any modifications may pose significant possible hazards and/or impair the continuous safe operation of the instrument. 9. DO NOT use a monopolar (unipolar) instrument as a bipolar cautery instrument. The use and proper placement of a patient neutral (dispersive) electrode is a key element in safe and effective electrosurgery. Follow manufacturer’s directions and recommended practices for the preparation, placement, use, surveillance and removal of the patient neutral (dispersive) electrode. 10. Core Electrodes are designed for use with Core Trumpet Hand Controls and Core Threaded Handle ONLY. DO NOT attempt to connect the probes to any other ES connector, handle, or instrument to avoid potential patient or clinician injury as well as potential damage to the product. 11. The risk associated with surgical smoke toxicity may be mitigated by the use of an appropriate smoke evacuation system. Follow hospital procedure for venting of the pneumoperitoneum. 12. When using the device to suction or irrigate, ensure the outer sheath is lowered or locked in the fully forward position to cover the electrode tip to prevent injury to underlying viscera. 13. Functional tip and shaft of this device are the Applied Parts.

PRECAUTIONS 1. 2. 3. 4.

Federal law (USA) restricts this device to sale by or on the order of a physician. Thoroughly inspect device for damage prior to initial use and subsequent re-use. If damage is found, instrument should not be used. During trocar insertion, always have the electrode tip covered to avoid potential damage to trocar seals and electrode tip. After use, this product may be a potential biohazard. Clean and re-sterilize as detailed in this IFU, or dispose of in accordance with hospital or facility medical practice and following local, state, and federal laws.

ConMed Corporation 5  25 French Road Utica, New York, 13502-5994 USA

For International orders or inquires, please contact CONMED International Sales +1 (315) 797-8375 • FAX +1 (315) 735-6235 www.conmed.com P/N P000019848 REV C 04/2022