Users Manual Part 1

2
Nerve Integrity Monitor
Intended use
The NIM Vital is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motor-
sensory nerves and registering EMG responses during surgery.
Indications for use
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.
Device description
The NIM Vital system is an intraoperative EMG monitor that enables users to locate and conrm 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.
Contraindications
The NIM Vital system is contraindicated for use with paralyzing anesthetic agents that will signicantly reduce, if not completely
eliminate, EMG responses to direct or passive nerve stimulation.
Warnings and precautions
It is important that the NIM Vital system intended operators be familiar with this manual: its warnings, precautions, procedures and
safety issues. Disregarding the information on safety is considered abnormal use.
Warnings
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.
a. To limit the paralytic eect of anesthetic agents, the anesthesiologist should monitor Train-of-Four (TOF) to prevent
diminished EMG activity. Consult anesthesiologist if EMG changes are observed.
W3 Surgical Identication 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.
a. The user is responsible for ensuring the electrodes are placed, or inserted into the target muscles. The electrode check, or
tap test only indicates that the electrodes are making contact with the patient’s tissue and does not indicate that the needle is
inserted into the correct muscle.
W4 To avoid the risk of re or explosion, do not use the Medtronic NIM Vital system in the presence of ammable 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:
a. Do not activate the electrosurgical instruments (ESU) while stimulator is in contact with tissue.
b. Do not leave dissection instruments, stimulating electrodes, or probes in surgical eld.
c. Do not store dissection instruments, stimulating electrodes, or probes in electrosurgical instrument holder.
d. Do not allow a second surgeon (for example, fat harvesting) to use electrosurgical instruments while stimulator is in use.
e. Do not activate electrosurgical instrument for prolonged periods while ESU is not in contact with tissue.
f. Do not activate electrosurgical instrument near the recording or stimulating electrodes.
g. Do not allow patient interfaces or recording / stimulating electrodes sites to be ooded with saline.
h. Do not allow excessive stray AC or DC leakage currents from patient connected equipment; Avoid creating an unintended
grounding path through applied electrodes.
Practitioner is responsible for proper use, periodic safety certication of patient connected equipment, and AC power
grounding in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 medical safety standard.
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:
a. other than Medtronic components as damage or substandard performance could result.
b. that are damaged components or accessories.
FCC use only, not for Medical use