NuVasive NVM5 Manual De Instrucciones página 15

Indications for Use
The NVM5 System is a medical device that is intended for intraoperative
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neurophysiologic monitoring during spinal surgery. The device provides information
directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5
provides this information by electrically stimulating nerves via electrodes located on
surgical accessories and monitoring electromyography (EMG), transcranial or lumbar
motor evoked potential (MEP), or somatosensory evoked potential (SSEP) responses
of nerves. The System also integrates Bendini
instrumentation for the placement of spinal rods.
• XLIF (Detection) – The XLIF (Detection) function allows the surgeon to locate and
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evaluate spinal nerves, and is used as a nerve avoidance tool.
• Basic & Dynamic Screw Test – The Screw Test functions allow the surgeon to locate
and evaluate spinal nerves by providing proximity information before, during or after
bone preparation and placement of bone screws.
• Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of
spinal nerves by continually displaying a live stream waveform of any mechanically
induced myotome contractions.
• Twitch Test (Train of Four) – The Twitch Test Function allows the surgeon to assess
moderate degrees of neuromuscular block in effect by evaluating muscle contraction
following a train of four stimulation pulses.
• MEP – Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques
for motor evoked potentials are used to assess for acute dysfunction in axonal
conduction of the corticospinal tract and peripheral nerves. The MEP function provides
an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway
integrity during procedures with a risk of surgically induced motor injury.
• SSEP – The SSEP function allows the surgeon to assess sensory spinal cord function
in surgical procedures during which the spinal cord is at risk.
• Remote Reader – The Remote Reader function provides real-time remote access to
the NVM5 System for a monitoring physician outside of the operating room.
• Guidance - The Guidance function is intended as an aid for use in either open or
percutaneous pedicle cannulation procedures in the lumbar and sacral spine (L1-S1)
of adult patients, and when used in conjunction with radiographic imaging and EMG,
allows the surgeon to assess the angulation of system accessories relative to patient
spinal anatomy for the creation of a cannulation trajectory for bone screw placement.
• Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant
system instrumentation (screws, hooks) to determine their relative location to one
another to generate bend instructions to shape a spinal rod. A surgeon is able to use
those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
INDICATIONS AND SAFETY
software used to locate spinal implant
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