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The Grass "DE-48-Plus Disposable Electrodes" are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.

The Grass Technologies DE48-Plus Disposable Electrodes (various lengths) are noninvasive, cutaneous devices, applied directly to the skin, and used in the acquisition of physiological signals for the purpose of montoring and recording Electroencephalograph (EEG), PSG and similar physiological parameters. Non-invasive, disposable surface electrode discs (Cutaneous Electrodes), as included in this submission, are applied to the skin using a cream or gel for adhesion. Their purpose is to pick up and transfer microvoltage signals, as generated by the body, to recording equipment, for the purpose of monitoring and recording associated with electroencephalography and electromyography. The new Grass DE-48-Plus electrodes, as with the BNT predicate, are manufactured with a circular, raised cup body molded from ABS plastic and coated with silver chloride (Ag/AgCl). The disc is adhered to a lead wire which is covered with heat shrink tubing and terminates with a molded connector that conforms to DIN 42-802 for electrical safety. Grass DE-48-Plus Electrodes connect to, and work with, any EEG equipment, without special attachments. The DE-48-Plus electrodes are made up of the following materials (same or equivalent to the Rhythmlink predicate). Cup Disk: ABS Plastic with an Aq/AqCl coating which is nominally measured at 10mm (8.5 to 10mm). The connecting wire which is manufactured from 28AWG stranded Tin Copper conductor with soft PVC insulation. Wire crimped to Cup Electrode using Tin plated copper tubing. Terminal connected with Alex crimp type, 24-30AWG Brass, Tin plated, Molded in Palprene.

The intended use for TWin Neurotrac-III is: To record the electroencephalogram (EEG) and the computed EEG trends over extended periods of time in order for trained health care professionals to observe changes over time. TWin Neurotrac-III does not provide any diagnostic conclusion about the patient's condition. TWin-Neurotrac-III is intended for use only by medically trained and qualified personnel, within a hospital or medical environment.

TWin Neurotrac-III is used with Grass-Technologies TWin (#K012976) EEG Recording and Review systems for displaying and recording long term trends of EEG features during continuous EEG monitoring in the ICU, NICU, OR, EEGIPSG laboratories, and/or inpatient long-term seizure monitoring units. TWin Neurotrac-III can be used with EEG acquisition systems configured with any of Grass-Technologies' amplifiers, including AS40 (#K021807), AURA (#K033978), AURA-LTM64 (#K053606) and Beehive (#K884937) amplifiers. The number of EEG channels recorded is dependent on the amplifiers used, the number of electrodes applied to the patient. and the user selected EEG display montage. In addition to displaying and recording the EEG waveforms. TWin Neurotrac-III can also display and record trends of user selectable EEG features in the EEG over prolonged periods of time. The number and the EEG channels processed are selected by the user.

The AURA-PSG amplifier system is intended for recording routine Electroencephalography (EEG) and Polysomnography (PSG). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in EEG and/or PSG.

AURA-PSG is a compact multi-channel amplifier and data acquisition device Aort F OO is a compoephalography (EEG) and polysomnography (PSG) recording applications. It provides for patient safety isolation, signal conditioning, and data sampling. The AURA-PSG amplifier system consists of two major components: the Amplifier Unit and the Base Station. The Amplifier Unit provides connections for electrodes and sensors and is normally worn by the subject in a vest or pocket. The Amplifier and sonoord and to hernRay istation using either a signal cable (tether) or a wireless connection. Both transmit digitized waveform to the Base Station where it is converted to standard network protocols and made available to supporting computers. AURA-PSG can be used for off-line, ambulatory recording. When used in this fashion, power is supplied by a battery and data is stored in internal memory. When the study is complete, data can be sent to a computer for review. The Base Station provides Menu selections for configuring the unit, communicating with the host computer, and implementing an electrode impedance test. It contains an LCD that can display status and other information. Power is supplied to the AURA-PSG Base Station through a rear connector that attaches to a medical-grade requlated power supply (+12 volts DC). The AURA-PSG Amplifier Unit is 5.5 inches x 3.5 inches by 1.0 inches and the AURA-PSG Base Station is approximately 7" x 6" x 2" inches. The Base Station can be attached to a cart arm, mounted on a wall or flat on a tabletop.

The ADAM amplifier system is intended for recording routine EEG and EEG associated with long term monitoring for epilepsy. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.

The ADAM amplifier system is an EEG Amplifier System.

Grass Brainwave Software is intended for use by qualified research and clinical professionals with specialized training in the use of EEG/PSG recording instrumentation for the digital recording, playback, and analysis of physiological signals. Its specifications and features make it especially well suited to electroencephalography and polygraphic sleep recordings.

The Grass® Night Vision is a Microsoft Windows95™ application software package for monitoring, recording, and reviewing physiological signals. It includes features for assisting the user with making measurements, marking significant events, and tabulating the events for easier interpretation. The software consists of two major modules, the Recorder and the Reviewer, and several minor modules for setup, montage editing, file management, and report generation. Together with a personal computer and a set of physiological signal conditioners (like the Grass® Model 15 amplifier system), the plight Vision software enables the user to replace or upgrade traditional strip-chart recorders used in the sleep laboratory with modern, digital recording and review methods.

Neurodata Amplifier System

The Model 15 combines up to 32 of the P511 amplifier circuits (in banks of 4) in a single enclosure and replaces the P511 manual switches with solid-state switches that are controlled via a standard RS-232 serial port. The Model 15 relies on the essential safely features of the P511 amplifier capacity-coupled patient circuit and safety-extra-low-voltage operation (12VDC) and improves on the safety of the P511 by isolating the patient applied circuits from the enclosure (earth).