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PEAK PlasmaBlade TnA Dissection Device

Indications, Safety, and Warnings

       

PEAK PlasmaBlade TnA Tissue Dissection Device

Indications

The PEAK PlasmaBlade TnA device is only indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (pharyngeal, tubal, palatine).

Adverse Events

As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could occur.

Warnings

  • Observe fire precautions at all times. An electrosurgical device may provide an ignition source due to sparking and heating.
  • Do not use in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide and oxygen. Do not activate the device until vapors from alcohol-based skin prepping agents have dissipated. Naturally occurring gases that accumulate in body cavities can also be an ignition source.
  • Proper suction connection is important to prevent a build-up of flammable or oxidizing gases at the surgical site. During use, monitor the device for inadequate suction performance, which might be apparent by excessive/visible smoke or burnt odor. Use the Cleaning Brush provided to remove excess eschar build up and maintain a clear channel for suction.
  • Do not contact metal objects and instruments with the PEAK PlasmaBlade while power is being applied as unintended tissue damage and electrode tip damage could occur.
  • Activation of the PEAK PlasmaBlade outside the field of view could cause patient injury.
  • Activation of the handpiece when not in contact with target tissue may cause capacitive coupling.
  • Do not allow patient contact with grounded metal objects, as such contact may result in patient or user injury.
  • Activation of the handpiece simultaneously while aspirating fluid may alter the path of electrical energy away from target tissue.
  • Inadvertent patient contact may result in burns. When not in use, place the device in a dry and nonconductive area away from the patient.
  • Ensure that only the active tip of the device is in contact with the patient during use.
  • Monopolar devices require a Patient Return Electrode. The unit must detect proper Patient Return Electrode impedance before generator output can be active. The impedance is continuously monitored and displayed while in Monopolar Mode. The unit presents audible and visible alarms if the unit detects improper impedance with the Patient Return Electrode in Monopolar Mode and will disable generator output. Refer to the manufacturer's instructions for application site and placement procedures when applying the Patient Return Electrode. Do not rely entirely on the impedance sensing feature as it can be affected by a damaged (shorted) Patient Return Electrode. It is recommended that the operator verify appropriate placement and contact of the Patient Return Electrode. Inadequate contact of the Patient Return Electrode may result in patient alternate site burns or injury.
  • Do not reuse, resterilize or reprocess the PEAK PlasmaBlade as it is supplied sterile and intended for Single Use Only. A device that has been resterilized or reprocessed may not perform properly and may result in patient or user injury.
  • Avoid fluid contact with the handle and its interfaces and connections as this may result in patient or user injury, or device failure.
  • Position the cable to avoid patient contact to protect against high frequency current paths to the patient as this may result in patient or user injury.
  • Position the cable to avoid creating a tripping hazard.
  • The use of electrosurgery in the presence of internal or external cardiac pacemakers is potentially hazardous. Interference from the electrical current can cause device malfunction. Consult the cardiac pacemaker manufacturer for further information before proceeding with the surgery.
  • The device should not be used near electrocardiograph electrodes as it can cause interference.
  • Ensure that the tip is fully seated into the suction shaft as any gaps may cause unintended tissue damage, and injury could occur.
  • Excessive bending may compromise performance and cause device failure, resulting in patient or user injury.
  • Postoperative bleeding is inherent to surgical procedures and may occur regardless of the electrosurgical hemostatic device used. Appropriate and thorough post-op surgical care should be administered to the patient.

Precautions

  • The PEAK PlasmaBlade should only be used by qualified medical personnel possessing training in the surgical procedures to be performed.
  • Take care when handling the electrode tip to prevent possible damage to the tip and to prevent user injury.
  • Take care when cleaning around the adenoid wire electrode, as excessive force may cause damage or breakage.
  • Use the lowest power setting and the shortest activation time possible to achieve the desired end effect.
  • Unless the product is being used to spot coagulate a vessel, it is recommended to keep the electrode tip in motion while activated to avoid excessive eschar buildup. Excessive eschar buildup can compromise device performance, including reduced or clogged suction.
  • Do not use sharp or abrasive instruments or materials to clean eschar buildup on the electrode tip as this may damage the tip.
  • When not in use, the device should be placed in a secure sterile location to prevent accidental damage to the tip.
  • Prior to initial use, ensure that all package inserts, including warnings, cautions, instructions for use, as well as the PULSAR Generator Operator’s Manual, are read and understood.
  • Prior to use, carefully inspect the package before opening. Do not use the device if the package appears damaged in any way. Return any damaged packages to Medtronic Advanced Energy, LLC.
  • Prior to use, inspect the PEAK PlasmaBlade for any defects. Do not use if insulation or connectors are damaged.
  • The PEAK PlasmaBlade is intended for use only with the PULSAR Generator.