Indications, Safety, and Warnings

The HET™ bipolar forceps and temperature monitor are intended to be used for grasping, manipulating, and coagulating soft tissue during general surgery. The HET™ bipolar system may be used for the treatment of symptomatic grade I and grade II internal hemorrhoids.

• Electrosurgical functional specifications: The maximum output voltage supplied by the electrosurgical generator in bipolar mode to the forceps should not exceed 1250 Vpeak.
• Do not exceed 10 W in the bipolar coagulation mode of operation for electrosurgical generators. Exceeding this limit may result in serious injury or surgical complications to the patient.
• Autobipolar mode should not be used with this system. The generator must be equipped with a footswitch.
• Read the instructions, warnings, and precautions provided by the manufacturer of the electrosurgical generator before use. The electrosurgical generator and accessories should be used according to manufacturer’s written instructions.
• Equipment manuals should be readily available to users and should be reviewed prior to using the system.
• Always inspect the monitor, electrosurgical unit (ESU) generator, and cables for wear, damage, frayed insulation, and proper function prior to each use.
• Caution should be exercised in patients with an increased risk of bleeding, whether by medication or other disease states. Before using the forceps and monitor, verify the patient’s medical history and review these precautions and specific warnings.
• The forceps is designed for use with the bipolar mode of operation and a coagulation (COAG) waveform of ESU generators ONLY at voltage and power settings that are limited to the maximum levels specified.
• Failure to adhere to the allowed maximum settings of the ESU generator may result in serious injury or complications to the patient.
• Electrosurgery should NEVER be performed in the presence of flammable anesthetics, flammable prep solutions, drapes, oxidizing gases such as nitrous oxide (N₂O), or in oxygen-enriched environments. The risk of igniting flammable gases or other materials is inherent in electrosurgery and cannot be eliminated by device design.
• Precautions must be taken to restrict flammable materials and substances from the electrosurgical site.
• Attention should be called to the danger of ignition of endogenous gases.
• Some materials (for example, cotton, wool, and gauze), when saturated with oxygen, may be ignited by sparks produced in normal use of the forceps.
• Use extreme caution when using electrosurgery in close proximity to or in direct contact with any metal objects. Do not activate the forceps while any portion of the bipolar electrode tip is in contact with another metal object; localized heating of the electrode and the adjacent metal object may result in injury to the patient and/or damage to the electrode tip.
• While using electrosurgery during a surgical procedure, the patient should not be allowed to come into direct contact with grounded metal objects (e.g., surgical table frame, instrument table, etc.).
• Activation of an electrosurgical device when not in contact with target tissue or in a position to deliver energy to the target tissue, but when in close approximation to a metal object, may result in capacitive coupling that could result in shock or discharge, and injury to the patient or operating personnel.
• To avoid alternate site burns or potential shock, remove all metal objects from the treatment area before using the forceps. It is not advisable to use this instrument in the proximity of jewelry, eyeglasses, digital watches, portable radios, pocket calculators, hearing aids, etc.
• Simultaneous use of an electrosurgical device with conductive irrigation fluid (such as saline) may alter the path of electrical energy away from the target tissue. Do not operate the forceps in the presence of saline or other conductive irrigation fluid.
• Electrosurgery may produce interference with implanted or external electronic devices controlling or monitoring physiological function. Electrosurgery may cause these devices to enter an asynchronous mode or may inhibit device operation entirely. Consult qualified personnel when using electrosurgery in patients implanted or otherwise connected with these devices. More information may be found in the Emissions and Immunity Guidance Tables in this document.
• Use only the forceps with the monitor. It is important to use the temperature monitor during delivery of the electrosurgical energy. It is recommended the delivery of energy cease when the temperature at the tissue treatment site reaches 55° C.
• The forceps tip may remain hot enough to cause burns after the electrosurgical current is deactivated.
• Do not irrigate the operative site while the forceps is in use.
• Testing conducted in porcine colon tissue has shown the zone of thermal injury to extend approximately 1 mm from the tissue contact electrode when the system is used as directed.

Precautions

• High-frequency electrosurgery inherently presents risks for the patient, clinical team, and the clinical environment. To mitigate risks associated with electrosurgery, the physician and the clinical staff must have adequate training and experience with electrosurgery to prevent serious injury, inadvertent tissue damage, or complications.
• The system is designed only for bipolar electrosurgery. ESU generators used with the system should be specifically designed for this purpose.
• The system is not intended for use with thermal units.
• The system is not intended for use with older, ground-referenced ESUs.
• Cables associated with the system should be positioned such that these cables do not contact the patient, clinical staff, and any other leads.
• Do not wrap accessory cords around metal objects. Wrapping cords around metal objects may induce currents that could lead to shocks, fires, or injury to the patient or clinical staff.
• Ensure the ESU’s audible output can be heard when the ESU generator is activated during electrosurgery when in use with the forceps.
• Do not apply ESU energy until you have an adequate visual image of the tissue site.
• Electrosurgical equipment should be used only by those properly trained in the specific procedure being undertaken. Compliance is required to the instructions, warnings, and precautions supplied by the ESU generator’s manufacturer when used with the HET™ bipolar system. Failure to adhere to these instructions, warnings, and precautions may result in serious injury to or surgical complications for the patient, including thermal damage to surrounding tissue.