Reusable Electrode Extender Instructions for Use

ENGLISH/INSTRUCTIONS FOR USE Reusable Electrode Extender

Non-sterile – Reusable / Autoclavable x 20 Description: Reusable handpiece accessory electrode. Autoclavable 20 times when maintained as indicated. Intended Use: This accessory electrode is used for conducting electrosurgical current from an electrosurgical handpiece through the electrode to the operative site for a desired surgical effect. Maximum generator voltage not to exceed 5.5KV Peak. CONMED electrodes have a 3/32 in. (2.38 mm) diameter shaft and are designed to fit CONMED and most other electrosurgical pencils and accessories. However, prior to use, it is important to check the electrode connection to the accessory you are using to assure proper fit and compatibility. Contraindications: These devices should never be used when: • There is visible evidence of damage to the exterior of the device, such as cracks, cuts, punctures, nicks, abrasions, discoloration or connector damage. • Where conventional monopolar electrosurgery is inappropriate or unsafe, such as for small appendages, in circumcision or finger surgery. • In the presence of flammable gases, flammable prep solutions or drapes, oxidizing gases, such as Nitrous Oxide (N 2O), or in oxygenenriched environments. Warning: • Devices are provided non-sterile. Clean and sterilize prior to initial and subsequent use. Do not attempt to sterilize by any method other than described herein. • To prevent accidental burns, do not activate generator until electrode is secure and directed at target tissue. Turn off generator before attempting to remove this extender. • Electrosurgery is potentially hazardous for patients with pacemakers, AICDs, neurostimulators or other active implants. High frequency energy may damage or adversely affect active implants. Ventricular fibrillation may occur. • Always place associated electrosurgical accessories in a safe insulated location, when not in use, to avoid burns. Precaution: • Before using this extender, refer to the instructions for use associated with the electrode, handpiece, and generator used with this device. • Electrosurgical accessories should be used only by surgeons/healthcare practitioners knowledgeable of electrosurgical techniques and safety. • Improperly installed electrodes may result in injury to the patient or operating room personnel from arcing at the pencil/electrode connection. Ensure this extender and electrodes are properly installed. • Use lowest possible electrosurgical generator power setting and shortest possible activation time capable of achieving the desired surgical effect. • Do not test the electrosurgical generator by sparking the active electrode to the patient plate or other objects. • After using device, this product should be considered a potential biohazard and cleaned and sterilized per procedure below. After twenty patient uses, dispose of device per hospital policy and applicable law. Inspection: These devices should be inspected before use and discarded if damage found. Visually examine the devices for obvious physical damage: • Cracked, broken or otherwise distorted plastic parts; • Damage including cuts, punctures, nicks abrasions, unusual lumps or significant discoloration. Cleaning Remove any obvious debris accumulated during use from the device with a soft, non-metallic instrument cleaning brush or cloth and mild detergent. Rinse with purified water. Use only lint-free cloth for drying. Sterilization • Steam/Pre-vacuum (Pulsing) - Place device into a double muslin wrap or equivalent dual self-sealing peel pouch, and place single layer onto an open tray in a flash pre-vacuum steam autoclave for sterilization. Process @132-135°C (270-275°F) for at least 3 minutes, not to exceed 4 minutes. Recommended drying time is 5 minutes minimum @ 132-135°C (270-275°F). • Steam/Gravity Displacement - Place device into a double muslin wrap or equivalent dual peel pouch, and place single layer onto an open tray in a flash gravity-displacement steam autoclave for sterilization. Process @ 132-135°C (270-275°F) for at least 10 minutes, not to exceed 15 minutes. Recommended drying time is 5 minutes minimum @ 132-135°C (270-275°F). Warranty CONMED Corporation warrants this product to be free from defects in materials and workmanship under normal operations and use for 90 days or 20 repeated uses, whichever occurs first, as a Hyfrecator® accessory. This warranty does not apply to any product that has been altered or serviced by anyone other than the manufacturer. Nor does it apply toward any product that has been damaged as a result of accident, abuse, misuse or negligence by the user. USA Federal law restricts this device to sale by or on the order of a physician.

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