NuVasive NVM5 Manual De Instrucciones página 17

WARNINGS AND PRECAUTIONS
Warnings and Precautions
Read all instructions and understand all warnings and cautions before using the NVM5
®
System and accessories. Failure to do so may lead to serious medical consequences.
Refer to the Instructions for Use accompanying other NuVasive devices before use with
®
the NVM5 System to assure proper and safe use of these devices.
WARNING: Patients with implanted electronic devices, such as cardiac pacemakers,
should not be subjected to electrical stimulation unless specialist medical opinion has first
been obtained.
WARNING: The MEP modality is capable of generating outputs exceeding 2mA RMS/cm²
in every stimulation current (from 200 to 1500mA)/pulse (1 to 8) combination. Prolonged
stimulation at outputs greater than 2mA RMS/cm² may result in skin burns.
WARNING: Chronically compressed nerves, or severely compressed nerves in an acute
setting, are known to be less sensitive to depolarization currents (i.e., have significantly
higher depolarization current values). They are also less likely to demonstrate significant
changes in their threshold depolarization current values immediately following nerve
decompression. Under such circumstances, exercise caution in interpreting displayed
data.
WARNING: The NVM5 System contains no user serviceable parts inside, and servicing
(other than that explicitly defined elsewhere in this manual) must be performed by the
manufacturer or its authorized agent.
WARNING: Do not use the NVM5 System in the presence of explosive gases. The device
is not explosion proof.
WARNING: To minimize the risk of electric shock, always connect the Patient Module
cable to the Control Unit before connecting the Patient Module to the patient EMG leads.
Also, always disconnect the patient EMG leads before removing the Patient Module cable
from the Control Unit.
WARNING: MEP scalp stimulation electrodes can deliver a high voltage shock. To avoid
shock, never handle both electrodes at the same time. Ensure both electrodes are
securely and properly attached to the patient before initiating any test.
WARNING: MEP stimulation may introduce additional hazards to the patient through use.
Examples of these hazards include: tongue or lip laceration, mandibular fracture, seizure,
cardiac arrhythmia, and scalp burn.
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