INDICATIONS
The Stim Bur Guard is indicated for nerve monitoring during the incision and removal of soft and hard tissue or bone with a standard bur / blade during otology, neurotology, sinus, laryngeal, nasopharyngeal, head and neck, general and plastic, and orthopedic surgical procedures, including spinal applications.
CONTRAINDICATIONS
None.
WARNINGS
It is important that the Stim Bur Guard operator be familiar with the Stim Bur Guard Instruction for Use, the NIM™ system manual, the bur manual, the XPS® 3000 BF manual / IPC™ manual, and their warnings, precautions, procedures, and safety issues.
Use only NIM™ nerve monitoring systems with the Stim Bur Guard to ensure delivery of current to intended tissues and adequate audio/visual monitoring.
If using the Stim Bur Guard for nerve mapping, use extreme caution to prevent inadvertent nerve damage.
The clinician(s) must have a thorough understanding of and experience with intraoperative EMG Monitoring prior to using the Stim Bur Guard in a surgical procedure. This device is not intended to replace the surgeon’s medical judgment or knowledge of neural anatomy and physiology. It is intended to provide the surgeon with an additional tool with which to make better-informed decisions regarding the surgical procedure.
The use of paralyzing anesthetic agents will significantly reduce, if not completely eliminate, EMG responses to direct or passive neural stimulation. Whenever nerve paralysis is suspected, consult anesthesiologist.
Avoid inadvertent activation of the handpiece while in close proximity to nerves.
Minimize guard contact with the patient during prolonged drill on-time to avoid thermal damage to surrounding tissue. The nose section of the Stim Bur Guard may become hot during prolonged on-time.
An appropriate amount of irrigation creates a moist contact point forming a meniscus about the bur head without covering more than 1/2 of the bur head. This moist contact point creates a low resistance connection to the patient while preventing thermal injury to the tissue. Excessive irrigation may prevent adequate current delivery to the tissue due to current shunting.