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The SEDLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

SEDLine is an EEG monitor designed for use in the OR, ICU, EEG laboratory and for clinical research. It provides the ability to acquire and display real-time EEG waveforms, process the real time EEG data using digital signal processing techniques, display the processed EEG data in several different formats, and archive the real-time or processed EEG data for future review. The SEDLine System consists of five components, the monitor, PSI algorithm, amplifier, patient cable and SEDTrace EEG Electrode Set. The device performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly.

The Sedline System is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

Sedline is an EEG monitor designed for use in the OR, ICU, EEG laboratory and for clinical research. It provides the ability to acquire and display real-time EEG waveforms, process the real time EEG data using digital signal processing techniques, display the processed EEG data in several different formats, and archive the real-time or processed EEG data for future review. The Sedline System consists of five components, the monitor, PSI algorithm, amplifier, patient cable and PSArray2 EEG Electrode Set. The device performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly.

The Physiometrix PSArray² EEG Electrode is applied directly to the patient's skin to enable recording of electrophysiologic signals (such as EEG).

The Physiometrix Model 4310, PSArray² EEG Electrode, is a single-use, disposable, pre-gelled electrode array. The PSArray² is comprised of six (6) electrodes located at F7, Fp1, FpZ', FpZ, Fp2 and F8. The electrode is packaged with 1 electrode per pouch, 25 pouches per box and 4 boxes per case. The electrodes are mounted in a polyethylene foam coated with a pressure sensitive adhesive. The electrode pad is an area of silver/silver chloride ink that is connected to cable connector by a silver ink trace. An electrolyte gel is held in place over the electrode pad by a open-cell polyurethane sponge located in wells created by the foam basepad. The electrolyte gel was selected for its low impedance properties. No pre-application prepping is required to achieve adequate impedance levels for operation of the PSA4000. The PSArray² EEG Electrode is connected to the PSA4000 System via a patient cable that attaches to the substrate connector. The PSArray² is designed for use with the PSA4000 System.

The PSA4000 is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI™), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

The PSA4000 is an EEG monitor designed for use in the OR, ICU, EEG laboratory and for clinical research. It provides the ability to acquire and display real-time EEG waveforms, process the real time EEG data using digital signal processing techniques, display the processed EEG data in several different formats, and archive the real-time or processed EEG data for future review. The PSA4000 consists of three main components, the monitor, the amplifier and the archive media (optional). The device performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly.

System for recording electroencephalogram of brain electrical activity to Host Digital EEG Machine.

The NeuroLink NeuroMonitoring System (predicate device) consists of a set of components that work together to acquire and present EEG signal to any existing EEG recording and analysis equipment. The components include Biosensor electrodes, e-Net headpiece, Patient Module, battery module, fiber optic cable, and DSP Interface Card. Changes in the Patient Module and power supply are described in this submission. An electrode headbox has been added to the Patient Module and an AC power supply is available as an alternate to the battery module. The Patient Module is a small battery powered or AC powered amplifier. The EEG signals are transmitted from the head via conventional electrodes that are input into the attached headbox or e-Net that has a mating connector on the patient module. Power is enabled when the Patient Module is plugged into the DSP Card via the fiber optic cable, the host digital EEG computer is in the powered state and the Patient Module is enabled by pressing the control button located on the Patient Module. A five meter fiber optic cable is standard. The fiber optic cable provides patient isolation and flexible patient EEG Record Station placement options. Self test, calibration and impedance tests are remotely activated from the Host Digital EEG Machine through the DSP Interface Card or locally by depressing the appropriate test button on the Patient Module. A visual indication of control button function, system status and out of range impedance can be provided on the LCD display as controlled from the Host Digital EEG Machine.

HydroPrep and NuPrep are skin preparation materials that are designed for use by EEG Technicians. Both substances are applied to the skin surface with a cotton swab in order to reduce skin impedance and increase signal quality recorded with EEG electrodes. HydroPrep is not intended for use with stimulating electrodes.

HydroPrep is a skin preparation solution similar to NuPrep. It is different in that is has more water and more salt that the current formulation. It used the same preservatives and gritty media.

preserving the full fidelity of the original EEG waveform data in the EEG patient population while providing tools for displaying and printing EEG waveforms for review and interpretation by trained health care professionals.

The Equinox™ Digital EEG System incorporates products produced by Physiometrix and Neuro Concepts to provide a superior system for EEG recording that provides cost benefits to the user. The Equinox™ System features several Physiometrix products including the Biosensor electrodes, e-Net headpiece. Patient Module, fiber optic cable and DSP Interface Card and computer hardware. The last component of the system is the Neuro Concepts software described in K905435B UNIQUANT'M System. The Equinox™ is an EEG system that offers a choice of paper or paperless approaches to reading of EEG records and automatic archival of EEG data onto optical disks. The highest priority of the system is to ensure the quality of the EEG data acquisition and storage thus preserving the full fidelity of the raw analog EEG waveform for reproduction onto paper or for display on a computer monitor. EEG data that is acquired on the Equinox™ System is always archived directly onto optical disk with no means available to the system operator to modify or process the raw digitized data.

The NeuroLink NeuroMonitoring System has the same intended use as the predicate device, the HydroDot NeuroMonitoring System. Both are designed to locate EEG electrodes according the 10-20 International System and present electrical signal sensed by the electrodes from the skin to existing EEG recording, analysis and archiving equipment.

The e-Net NeuroMonitoring System consists of a set of components that work together to acquire and present EEG signal to any existing EEG recording and analysis equipment. The components in the original submission included Biosensor electrodes, e-Net headpiece, Patient Module, fiber optic interface, Monitor Module, AC power supply, and EEG Adapter Cable. The components of this submission include Biosensor electrodes, e-Net headpiece, Patient Module, fiber optic interface, and DSP Interface Card (replaces Monitor Module). The AC power supply and EEG Adapter Cable have been eliminated. The modified system discussed in this submission uses the same electrodes and headpiece for signal acquisition but has changes in the modules used to transmit signals to the existing EEG recording and analysis equipment. The Patient Module is a small battery powered unit attached to the patient. Power is enabled when the Patient Module is plugged into the DSP Card via the fiber optic cable, the host digital EEG computer is in the powered state and the Patient Module is enabled by pressing the control button located on the Patient Module. A five meter fiber optic cable is standard. The fiber optic cable provides outstanding patient isolation and flexible patient EEG Record Station placement options. A connector located at the top end of the module attaches to our standard e-Net headpiece or optionally a mini-jack for interface to standard cup electrodes. Self test, calibration and impedance tests are remotely activated from the host Digital EEG Machine through the DSP Interface Card or locally by depressing the appropriate test button on the Patient Module. A visual indication of control button function, system status and out of range impedance can be provided on the LCD display as controlled from the host Digital EEG Machine.