30 January, 2020
a
Preface
Indications for use statement
The Nicolet EDX is intended for the acquisition, display, analysis, storage,
reporting, and management of electrophysiological information from the human
nervous and muscular systems including:
•
Nerve Conduction (NCS)
•
Electromyography (EMG)
•
Intra-Operative Monitoring including Electroencephalography (EEG)
•
Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory
Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP)
•
Electroretinography (ERG)
•
Electrooculography (EOG)
•
P300
•
Contingent Negative Variation (CNV)
•
Motor Evoked Potentials (MEP)
The Nicolet EDX may be used to determine autonomic responses to physiologic
stimuli by measuring the change in electrical resistance between two electrodes
(Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing
also includes assessment of RR Interval variability.
The Synergy EDX / Viking EDX software is used to detect changes in the
functional state of the nervous system, for the location of neural structures during
surgery and to support the diagnosis of neuromuscular disease or condition.
The listed modalities include overlap in functionality. In general,
•
Nerve Conduction Studies measure the electrical responses of the nerve.
•
Electromyography measures the electrical activity of the muscle.
•
Evoked Potentials measure electrical activity from the Central Nervous
System.
The Nicolet Synergy EDX / Viking EDX software is intended to be used by a
qualified healthcare provider.
Summary of Contents for Nicolet Synergy EDX
Page 2: ......
Page 10: ...Nicolet EDX h 30 January 2020 Blank page...
Page 15: ...January 30 2020 1 1 1 Introduction...
Page 16: ...Nicolet EDX 1 2 January 30 2020 Blank page...
Page 22: ...Nicolet EDX 2 2 January 30 2020 Blank Page...
Page 54: ...Nicolet EDX 3 2 January 30 2020 Blank page...
Page 58: ...Nicolet EDX 3 6 January 30 2020 Blank page...
Page 60: ...Nicolet EDX 4 2 January 30 2020 Blank page...
Page 72: ...Nicolet EDX 4 14 January 30 2020 Blank page...
Page 74: ...Nicolet EDX 5 2 January 30 2020 Blank page...
Page 86: ...Nicolet EDX 5 14 January 30 2020 Blank page...
Page 88: ...Nicolet EDX 6 2 January 30 2020 Blank page...