April 27, 2015 a
Preface
Intended use statement
The device is intended to be used as a front end Nicolet EEGwireless32/64
amplifier with the Nicolet Neurodiagnostic system to record, measure, store,
analyze and display cerebral and extracerebral physiologic data for EEG and
Sleep studies with or without synchronous digital video. This data includes but is
not limited to EEG, EOG, EMG, ECG, respiration, body position, snore, heart
rate, oxygen saturation and other physiologic signals. All ages of patients are
served, including infants either within a medical facility or outside a medical
facility. It is intended for use only under the supervision of medically trained and
qualified professionals who will use all available information to aid in the
diagnosis of Sleep, Epilepsy and other related disorders. While the Nicolet
Neurodiagnostic systems are capable of displaying signals, such as Sp02 and
ECG, the system is NOT intended for monitoring such signals for the
preservation of life.
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