The NIM Vital™ nerve monitoring system is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor, and mixed motor-sensory nerves and registering EMG responses during surgery.
The NIM Vital™ system may be used for EMG monitoring in support of surgical procedures including: intracranial, extracranial, intratemporal, extratemporal, and surgeries associated with the neck, spine, thorax, and upper and lower extremities.
The NIM Vital™ system is an intraoperative EMG monitor that enables users to locate and confirm the integrity of nerves during surgical procedures.
The system stimulates nerves (propagates an action potential) through a variety of stimulation probes that causes the muscle associated with the nerve to contract. The system then picks up these electric signals from the muscles through a variety of electrodes and converts this information into meaningful graphs and sounds that the system displays on the monitor.
The system also continuously monitors EMG activity from the muscles innervated by the nerve at risk.
The NIM Vital™ system is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation.
It is important that the NIM Vital™ system intended operators be familiar with the NIM Vital™ Instructions for Use: its warnings, precautions, procedures, and safety issues. Disregarding the information on safety is considered abnormal use.
|W1||The NIM Vital™ system does not prevent the surgical severing of nerves. If monitoring is compromised, the surgical practitioner must rely on alternate methods, or surgical skills, experience, and anatomical knowledge to prevent damage to nerves.|
|W2||If paralyzing anesthetic agents have been used, patient must regain muscle activity prior to use of the NIM Vital™ EMG Monitor.
|W3||Surgical identification of exposed nerves is key to their preservation. Failure to use Medtronic’s nerve stimulation probe may contribute to unintended surgical nerve damage or resection.
|W4||To avoid the risk of fire or explosion, do not use the Medtronic NIM Vital™ system in the presence of flammable anesthetics and/or oxygen-rich environment.|
|W5||After each procedure, properly clean and disinfect all reusable system components.|
|W6||To avoid alternate site patient burns or lesions when patient interface is connected to the NIM Vital™ console through the patient interface cord:
|W7||Disconnect power to the console before cleaning the unit to avoid electrical macro shock.|
|W8||Achieve electrical grounding reliability with proper connections. Connect the console to hospital grade receptacles only.|
|W9||Do not use any parts:
|W10||This medical device complies with IEC/EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient.|
False negative responses, failure to identify nerve, a condition where probe is on nerve but you do not get an EMG tone may result from: