Safety Considerations

Ensuring the safety of the patient and clinical staff is extremely important to Domain Surgical. Reading the following information may help provide the safest and most clinically effective surgical experience possible.

  • FMX™ surgical tools (FMwand® and FMsealer™) heat instantly and cool in seconds. Be sure to allow sufficient time (typically less than 4 seconds) for the active heating element to return to ambient temperature before using as a probe/retractor, or before laying the device with tip on the surgical drape. It is recommended to place instruments on a wet, sterile towel when not in use.
  • Contacting the active tip of any thermal surgical device while activated may result in injury.
  • Use the lowest power level and the shortest activation time necessary to achieve the desired surgical effect.
  • Let the heating element tip do the work to achieve smooth precise, dissection and to avoid traction through the tissue.
  • When dissecting tissue with the FMwand, some vessels can be pretreated by "painting" them with the FMwand on a low (5W - 15W) FMmin power setting. Vessels larger than 1-2 mm in diameter should be sealed first with a vessel sealing tool, such as the FMsealer.
  • Smoke generated during surgical procedures can obscure visibility of the operative site and may be potentially harmful. It is recommended to use surgical masks and adequate ventilation or evacuation of smoke. FMwand 2S models feature integrated smoke evacuation and can be used with any surgical suction or smoke evacuation system.
  • Do not reuse, re-sterilize, or reprocess "Single Use Only" labeled accessories. Reuse of "Single Use Only" devices risks cross-contamination of substances, bacteria, and viruses between patients.
  • Monopolar electrosurgery devices typically emit a spark with the potential to ignite airway oxygen, flammable liquids or vapors from alochol-based skin prep agents, cleaning agents, or solvents. The FMwand and FMsealer do not emit sparks.

For additional information, please refer to Domain Surgical's Directions for Use documents.

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