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General Information
User Guide
This guide provides the basic information needed to setup, operate and maintain the Dantec Keypoint G4 system.
A PDF copy of this user guide is available on the USB drive provided with the Dantec system. Copies of the user guide may also be accessed at
natus.com in the Support section. Scroll to the EMG Product IFUs, select Dantec Keypoint G4 and choose the version for your local language.
The files can be printed, saved, or searched using Adobe Reader. A copy of Adobe Reader can be downloaded directly from Adobe Systems
(www.adobe.com). A paper copy of the Instructions for Use in available languages can be obtained by contacting Natus Technical Support, or
by contacting a Natus representative.
Intended Use
Keypoint G4 is intended as an electrophysiological aid to assess diagnosis and prognosis, and to monitor diseases of the central and peripheral
nervous system. It can also be used to study functional aspects of nerves and muscles in other fields such as rehabilitation (physical medicine),
occupational medicine and sports medicine.
System Overview
The Keypoint G4 system is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from
the human nervous and muscular systems in adult and pediatric patients. Keypoint G4 provides the ability to conduct electrodiagnostic testing
including nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing and Autonomic studies. It is
designed to address the testing requirements for medical professionals in hospitals and private practice. Optional software programs and
accessories allow the user to customize the Keypoint G4 system to meet specific clinical requirements.
The Primary Operating functions of the Keypoint G4 system include:
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System startup with device check
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Test protocol selection, customization and execution
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Control of amplifier signals
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Control of electrical, visual and auditory stimuli
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User-controlled data review and analysis
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Reporting and test result summaries
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Storage and retrieval of recorded data
Clinical Performance
The Keypoint G4 allows the user to perform a wide range of Nerve Conduction Studies (NCS), Electromyography (EMG), Evoked Potential (EP)
Studies and Autonomic Studies. Separate software programs and optional accessories allow the user to customize the Keypoint G4 to meet
specific clinical and O.R. monitoring needs.
Clinical Benefits
The Keypoint G4 system assists the physician in collecting measurements and waveforms of the nerves and muscles in the body to support the
diagnosis of neuromuscular disease. Disease is indicated when measurements fall outside of expected or normative ranges. The Keypoint G4
system facilitates the diagnostic evaluation of diseases such as carpal tunnel, radiculopathy, nerve lesions, several types of dystrophy, and
other diseases of the nervous and muscular system.
Medical Conditions
Neuromuscular disease is suspected when a patient complains of abnormal sensations such as tingling, numbness, pain, weakness and/or
abnormal movements including tremor or spontaneous contractions. Electrodiagnostic testing and monitoring is performed on patients with
suspected or confirmed neuromuscular diseases including muscular dystrophy, motor neuron disease (ALS), polio, myasthenia gravis,
peripheral neuropathies, radiculopathies, myopathies, carpal tunnel syndrome, and multiple sclerosis.
Intended Users
The Keypoint G4 is intended to be used by a qualified healthcare provider. Qualified healthcare providers include those with specialized
training in the use of Electrodiagnostic (EDX) instrumentation for the acquisition, display, analysis, storage, reporting, and management of
electrophysiological information from the human nervous and muscular system.
