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The Harmonie System is indicated for the acquisition, display, review, analysis and archiving of physiological signals including patient video obtained during routine EEG examinations, Long-Term Monitoring in Epilepsy (LTM) and Sleep Studies (polysomnography or PSG) in patients of all ages. The seizure detection component of the software is intended for post-hoc review for marking sections of the EEG that may correspond to electrographic seizures in adults only. The Burst-Suppression component is intended to be used for the quantification and recognition (mark) of sections of the EEG and PSG that may contain patterns of interest. The seizure detection component and Burst-Suppression Module are for use in adults only. The Harmonie software is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intra-operative settings. In no way are any of the system functions represented as being in and of themselves diagnostic. The system requires competent user input, and its output must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.

The Harmonie System is a data acquisition device that can record up to 128 channels of EEG and PSG signals at sample rates ranging from 200Hz to 2000Hz per channel according to the specifications of each model. EEG and PSG signals are amplified, filtered and digitized. A Photic Stimulator is optionally provided with the system. The system can also concurrently record synchronized digital patient video, through an optional MPEG4 encoder card and the DV software module. The digital data (EEG and digital video) is stored on the computer workstation's hard disk for review and analysis, either during or after a recording session. Following is the functional description of various Harmonie models: - 1. Harmonie System with DUO Recorder This is a basic EEG recording system, typically used for routine EEG examination. The DUO recorder is a 20-bit, 44-channel amplifier with user programmable filters, automatic anti-aliasing and sampling rates of up to 2,000 Hz. All components are mounted on a robust enclosed cart, which can accommodate a Photic Stimulator and various models of CCTV cameras, as accessories. The system includes Harmonie EEG software that allows acquisition, display, review, analysis and archiving of EEG data locally or at a remote station. - 2. Harmonie-S System with DUO Recorder The Harmonie-S system uses same DUO recorder described above but uses PSG software to record sleep studies. It includes optionally digital video recording. The amplifier and video camera are placed in the room. The computer and monitor are placed in an observation room where the PSG technologist works. The software includes the Harmonie EEG and the PSG modules. The PSG module is designed specifically for the visualization and scoring of variables commonly used in sleep studies, such as the EEG, EMG, EKG, oxygen saturation, body position , eye movements and respiration signals. The system allows performing the main functions of a sleep study: sleep staging, manual event marking, displaying graphs of sleep stages and events, and various sleep report generation. - MESA II System with DUO Recorder 3. MESA-II is a portable system suitable for EEG examinations, also using the DUO EEG amplifier. It offers the full functionality of the standard Harmonie system, but with a laptop computer and other components mounted on a cart with a smaller foot-print, which enables EEG examinations to be performed in space-limited environments. The cart can accommodate a Photic Stimulator and various models of CCTV cameras, as accessories. The system includes Harmonie EEG software that allows acquisition, display, review, analysis and archiving of EEG data locally or at a remote station. - Vita ICU System with DUO Recorder 4. The Vita ICU system is an EEG recording system designed to facilitate EEG recordings in the ICU, although it can also be used as a routine EEG system. It includes optionally digital video recording. The Vita ICU system is composed of a panel PC (computer and monitor in the same physical entity), including a touch-screen monitor, and is mounted on small footprint cart. It includes the Harmonie EEG software as well as software specific for this application (the Vita ICU software). The Vita ICU software includes a touch-screen interface to facilitate user-interaction with the device. - 5. Harmonie-E System with eAmp Recorder The Harmonie-E system with eAmp recorder is an EEG recording system designed for LTM particularly in the context of the evaluation of patients with epilepsy. The eAmp is an IP-enabled amplifier with the capability to acquire data for up to 128 channels (by combining two 64-channel units). It includes programmable filters from 0.1 to 500Hz and sampling rates up to 2,000Hz that allow measurement of higher frequency EEG. The system includes digital video recording. The amplifier and video camera are placed in the room and the recording computer and monitor and placed in a control room. The system includes Harmonie EEG software that allows acquisition, display, review, analysis and archiving of EEG data locally or at a remote station. The Harmonie-E module for the automatic marking of EEG events of interest, i.e. spike patterns and seizure patterns. This post-hock review marking facilitates the review of the long EEG recordings. - Harmonie-E System with EEG64 Recorder 6. The Harmonie-E system with Schwarzer EEG64 recorder is an EEG recording system designed for LTM particularly in the context of the evaluation of patients with epilepsy. The Schwarzer EEG64 amplifier is equivalent to eAmp with slightly different filtering characteristics than the eAMP amplifier. The system includes Harmonie EEG software that allows acquisition, display, review, analysis and archiving of EEG data locally or at a remote station.

The Notta Ambulatory Recorder is indicated for the recording and study of EEG and other physiological signals obtained during routine EEG exams, long-term monitoring in epilepsy (LTM) and sleep studies (PSG or polysomnography) either at home, at a clinical setting, or other suitable environment under physician's order. The Notta Ambulatory Recorder is indicated for use with children and adults under the supervision of a physician or other trained health care professional. The device is intended to be worn by the patient during a recording session. The Notta Ambulatory Recorder is not intended to be used for the monitoring of vital sigus, in critical care or intra-operative settings. In no way are any of the device functions represented as being in and of themselves diagnostic. The system requires competent user input, and its output must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.

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The indications for use of the Luna™ software for Windows® 95 are the same as those of Stellate Systems' ECLIPSE Version 3.0 software for MS-DOS®. J.una™ can be used only in conjunction with Stellate Systems' HARMONIE™ software package. Luna™ may be used for sleep recordings (polysomnography) in research or clinical cuvironments for: - · Digital rooording of high-level output signals (such as EBO, respiratory and oximety signals) from the Digital recording of might-level cations (society costs of amplifiers, by means of a personal computer (PC) and PC-based data acquisition board. - · Selection of recorded signal sections for on-sereen review, annotation and marking of sleep stages. - · Manual event-marking and annotation of polygraphic signal sections. - · Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximelry signals. - · Computer-assisted reporting of simple measures obtained from the recorded signals (such as magnitude, time and frequency, and simple statistical measures of marked events.) The software is not intended to replace conventional devices or methods used for sloup monitoring in critical care or intra-operative scilings. The software requires competent user input, and its output must be reviewed and interpreted by trained The sollware requires or neurologists who will excruise professional judgment in using this information. The software does not make any judgment of normality of the displayed signals or of the results of an analysis. In no way are any of the software functions represented as being in and of themselves diagnostic. Prescription Use (Per 21 CFR 801.109)

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for the indications for use stated in the enclosure

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HARMONIE™ and Sensa™ is a set of software programs which represent an improved implementation of Stellate Systems' RHYTHM and MONITOR software. The software remains consistent with its original design objectives: - to assist in the scientific analysis of the electroencephalogram (EEG) in the field of human and animal neurophysiology. - to offer digital EEG recording by means of a personal computer and PC-based data acquisition boards. - to assist in the selection of EEG sections of potential interest and offer a variety of display, playback and review capabilities. - to complement the conventional continuous EEG recording, not replace it. The software does not make any judgment of normality of the displayed EEG or the results of an analysis. It is not intended EEG monitoring used in critical care or intra-operative cettings. In no way is the software or its function represented as being in and of itself divenestic

HARMONIE and Sensa EEG Software