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To record the electroencephalogram (EEG) and evoked potentials (EP's) over extended periods of time such as during surgery and intensive care stays in order for trained health care professionals to observe changes. The intended use of the Neurotrac II-EP is to monitor the electroencephalogram (EEG) and evoked potentials (EP's) over extended periods of time such as during surgery and intensive care stays in order to observe changes. The Neurotrac II-EP acts as a patient monitor as it displays EEG waveforms, performs calculations on the data and triggers alarms when user-defined limits are exceeded. In addition, the Neurotrac II-EP is an evoked potential measuring device designed to record and measure the brain stem and the somatosensory pathways in order to evaluate nervous system function. It stores monitored waveforms for retrospective on-screen review or for hard copy interpretation. Use of the Neurotrac II-EP is indicated when electroencephalographic (EEG) and/or evoked potential (EP) monitoring is required during surgery or intensive care over extended periods of time.

The Neurotrac II-EP provides continuous monitoring of brain electrical activity (EEG) and monitoring of evoked electrical activity from the central and peripheral nervous system (EP). The system provides for recording of any combination of EEG/EP and displays the results. The system not only displays the raw EEG waveform but processes the EEG in ways which make it easier to detect changes in the amplitude and frequency of the signal. The amplitude and frequency of the signal are the two main characteristics of the EEG. In addition to displaying the EEG, the raw input of the EP waveform as well as it's average are displayed. The system processes the EP waveform which makes it easier to detect changes in the amplitude and latency of the signal. The amplitude and latency of the signal are the two main characteristics of the EP. The Neurotrac II-EP also provides clinicians the capability of reviewing collected data. All raw EEG and EP waveforms and computer processed information may be stored on an internal hard drive or a removable cartridge hard drive for retrieval at a later time. All data can be printed for immediate hard copy interpretation. The Neurotrac II-EP is an enhanced version of the original Neurotrac II. The Neurotrac II-EP monitors brain function via the electroencephalogram (EEG) and via evoked potentials (EP). The product will be sold as Neurotrac II-EP configured with hardware and software for both continuous EEG, auditory and somatosensory evoked potential monitoring. The amplifiers, processor unit and evoked potential stimulator of the Neurotrac II-EP system will be manufactured by Moberg Medical. These components are connected to the M1094 Display, manufactured by Hewlett-Packard (HP), to complete the basic Neurotrac II-EP system. The amplifiers are housed in a connecting box (headbox) which accepts one of several patented "Personality Cards (PCARD)". The electrode leadwires connect into the PCARD which shows the user where to connect the patient electrodes on the head and configures user defined monitoring procedures for different clinical applications. The PCARD only accepts electrodes with DIN 42 802 standard touch proof connectors. The evoked potential stimulator includes both auditory and electrical outputs. These are delivered to the patient by industry standard auditory headphones or tubephones and FDA approved electrodes for electrical stimulation. The electrical stimulator provides for six standard current level outputs and two low current level outputs. The low current level outputs are designed to be used with custom electrodes, provided with the Neurotrac II-EP. These custom electrodes provide for additional patient safety by prohibiting their use in standard higher current level outputs. A keyboard and mouse are provided for entry of alpha numeric information and changes with pull-down menus for parameters. Accessories to the product are a computer cart for portability, an audio-output for listening to electrical impulses from selected nerves or muscles, a manual switch box to select electrical outputs, a safety agency approved external storage device (i.e. hard drive, optical) and a PCL5 compatible printer for hard copy printouts. The HP Display, Model M1094 provides the electrical power for the MMI processor, amplifiers, evoked potential stimulator and audio speaker.