Users Manual Part 1
3
Nerve Integrity Monitor
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.
W11 It is important that the NIM Vital operator be familiar with this manual, its precautions, procedures and safety issues.
W12 To avoid electrical shock, do not attach unapproved components or accessories to the Medtronic NIM Vital system.
W13 All service must be performed by Medtronic qualied personnel only, unless otherwise noted.
W14 Do not directly contact active, implanted devices with the stimulator as it may disrupt the implanted device’s operation.
Consult medical specialist before use.
W15 Electrocardiogram monitoring artifacts may be caused by Medtronic NIM stimulus current delivery or EMG electrode
impedance monitoring.
W16 Use of unapproved stimulators, stimulus probes, stimulus dissection instruments or electrodes may result in compromised
Medtronic NIM operation, such as, but not limited to decreased accuracy.
W17 Repair and/or modication to the Medtronic NIM or any accessory by anyone other than qualied service personnel may
signicantly compromise the unit’s ability to monitor nerve activity and/or void the equipment warranty.
W18 To avoid the risk of infection, the user must maintain good sterility practices.
W19 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:
a. Shorted EMG electrode or cabling (conductive parts of applied needle electrodes or cables contacting each other).
b. Patient Interface fuse blown and not detected (32mA, 250V. Xomed Part No.: 8253075).
c. Patient Interface defective.
d. Inadequate stimulus current.
e. Inadequate current for stimulation of nerve through hardware, such as stimulus dissection instruments, may vary based on
the physical size, shape characteristics, and design of the hardware and proximity to the nerve.
f. Simultaneous stimulation of the nerve and the surrounding tissue, resulting in current shunting (inadequate delivery of
stimulus current to target nerve tissue).
g. Flatline on the EMG channel caused by shorted internal amplier (characterized by baseline activity of < 3μV peak-to-peak).
h. EMG electrodes not positioned properly in the target muscles.
W20 Stimulator current may cause involuntary patient movement resulting in patient injury.
W21 If the incrementing probe handle malfunctions, it could result in increased current delivery to the patient. Immediately
disconnect the Control Plug from the Patient Interface box and use the console to adjust stimulus current.
W22 Be careful not to damage vascular or neural structures when preparing the nerve for the installation of the continuous
monitoring electrodes.
W23 Electrode integrity should be checked after electrode insertion and before electrode removal to give additional assurance that
electrode continuity was maintained throughout the entire procedure. If the system indicates improper electrode impedance,
consult the “Troubleshooting” topic for impedance value troubleshooting.
W24 Remove continuous monitoring electrode from patient prior to using external debrillator to prevent thermal injury to patient
at continuous monitoring electrode site.
W25 Operation in close proximity to high frequency (shortwave or microwave) equipment may produce instability in the electrical
stimulator output.
W26 Safe stimulus levels are dependent on various conditions including but not limited to: type of excitable tissue, Charge
Per Pulse, and Charge Per Unit Area. Waveform morphology, repetition rate, and stimulator eective surface area must be
considered. Special operator (Neurophysiologist) attention is required for stimulus levels which exceed default settings or
conditions. Levels higher than 2mA RMS/cm2 (3 mA) for Slim Prass Probe and Prass Bipolar Probe may result in tissue damage.
W27 Do not perform Magnetic Resonance Imaging (MRI) on a patient with electrodes, probes, and EMG tubes in the eld. The
eect of MRI is unknown on these devices.
W28 Loud extraneous monitoring noise may be caused by activation of electrosurgical unit. Muting Detector, if necessary, must be
properly attached to the active electrosurgical lead.
W29 User is responsible for at minimum annual functional and safety checks.
W30 Avoid trans-thoracic stimulation; when possible, maintain anode and cathode stimulating sites in close proximity.
W31 Do not use if sterile package has been opened or is damaged.
Precautions
P1 Medical Electrical Equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be
installed and put into service according to the EMC information provided in this Guide.
P2 Portable and mobile RF including cell phones and communications equipment can aect Medical Electrical Equipment.
P3 Use of accessories and cables other than those specied and sold by Medtronic may result in increased emissions and
decreased immunity of this unit.
P4 The NIM Vital system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary,
the NIM Vital should be observed to verify normal operation in the conguration in which it will be used.
FCC use only, not for Medical use