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The Falcon HST is an EEG and respiratory signal recorder. The device is intended for use by adult patients in the home or clinical environment, under the direction of a qualified healthcare practitioner, to aid in the diagnosis of sleep disorders.

The Falcon HST comprises hardware and software which provide separate parameters for recording, review, and analysis of collected and stored physiological parameters, including EEG, EOG, ECG and respiratory signals, which are then used as an aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians. The Falcon system consists of the main unit and the charging cradle. The main unit is a small device that is worn on the patient's chest over clothing. It is equipped with a touch-screen LCD and contains various channel inputs such as for the inductive plethysmography bands, and electrodes. The Falcon charging cradle is used to charge the device, as well as provide a USB interface for transferring study data to the PC.

Noxturnal Web is intended to be used for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only. Noxturnal Web is a software-only medical device to be used to analyze physiological signals and manually score sleep study results, including the staging of sleep, AHI, and detection of sleep disordered breathing events including obstructive apneas. It is intended to be used under the supervision of a clinician in a clinical environment.

Noxturnal Web is a web-based software that can be utilized to screen various sleep and respiratoryrelated sleep disorders. The users of Noxturnal Web are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. Users can input a sleep study recording stored on the cloud (electronic medical record repository) using their established credentials. Once the sleep study data has been retrieved, the Noxturnal Web software can be used to display, manually analyze, generate reports and print the prerecorded physiological signals. Noxturnal Web is used to read sleep study data for the display, analysis, summarization, and retrieval of physiological parameters recorded during sleep and awake. Noxturnal Web facilitates a user to review or manually score a sleep study either before the initiation of treatment or during the treatment follow-up for various sleep and respiratory-related sleep disorders. Noxturnal Web presents information from the input sleep study data in an organized layout. Multiple visualization layouts (e.g., Study Overview, Respiratory Signal Sheet, etc.) are available to allow the users to optimize the visualization of key data components. The reports generated by Noxturnal Web allow the inclusion of custom user comments, and these reports can then be viewed on the screen and/or printed.

The HomeSleepTest is a non-invasive prescription device for home use with patients suspected to have sleep disorders including sleep-related breathing disorders. The HomeSleepTest is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level. Using three frontal electrodes and one mastoid electrode, the HomeSleepTest records electrical data. In addition, the device records triaxial accelerometer data, ambient light and acoustic data. With help of the ComfortOxyRing, the device records plethysmographic data, as well as SpO2, heart rate and activity data. The HomeSleepTest calculates and reports to clinicians EEG/EOG/EMG, sleep stages, SpO2, plethysmography, pulse rate and snoring level. Based on this, the HomeSleepTest indices derived parameters, such as autonomic arousal (based on plethysmogram of ring), oxygen desaturation index and hypnogram-derived indices, such as time in each sleep stage, as well as other sleep-related parameters, to aid in determining sleep quality and quantity. HomeSleepTest data is not intended to be used as the sole or primary basis for diagnosing any sleep disorders, or sleep-related breathing disorders, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The HomeSleepTest is not intended for use in life-support and monitoring systems. The HomeSleepTest and its accessories are not intended for patients requiring monitoring and intensive care. The HomeSleepTest is a prescription device indicated for adult patients aged 21 years and over.

The HomeSleepTest is used to record vital signs to determine a hypnogram (sleep profile) and sleep parameters that can be helpful in objectively determining sleep quality and quantity. The HomeSleepTest is available in a standard HomeSleepTest (HST) version and a HomeSleepTest REM+ (HST REM+) version. The only difference between the two basic devices is the measuring point of the outer electrodes on the forehead. HomeSleepTest refers to both versions of the device. Furthermore, the HomeSleepTest can be used to detect the patient's activity, head position and snoring. A recording with the HomeSleepTest is initialized in the clinic/practice. For this purpose, the patient is given the HomeSleepTest and a tablet to take home. The recording can thus be carried out independently in the home environment. Immediately after recording, the data is automatically transferred to the HST cloud. The physician has access to this data via the HST cloud where they can analyze the data via the HST cloud in DOMINO and generate a report. A tablet app with video sequences supports the patient in correct application and guides them through the required biocalibration of the system. Once the test is started, all data from the HomeSleepTest is recorded via Bluetooth. The HomeSleepTest records nine signals (3 x frontopolar EEG, 2 x EOG, EMG, snoring, activity and head position). Snoring and snoring rhythm are recorded via the tablet's microphone. Head position, movement and light support information about time in bed (TIB) and other sleep-related parameters. After completion of the measurement the next morning by the patient, the data is automatically uploaded to the HST cloud where it can be analyzed with help of DOMINO software. After the data has been successfully transferred to the cloud, an exchange with the physician is possible via the feed-back function. It is also possible to release a new measurement for this patient, so that recordings can be made over several nights to capture variability. An overview of all measurements is available to the physician in the HST Cloud. A chat area is used for communication between doctor and patient. In the cloud-based evaluation software, both the pre-evaluation and the raw data of the measurement should be analyzed or edited in an AASM compliant manner. A simple report is available immediately after uploading the measurement. However, the recorded data must still be verified by a physician: for the detailed report (standard report), the measurement is opened in the DOMINO software and scored manually. After evaluation, the standard report is also available in the overview and provides additional information on the various sleep parameters.

The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. The system uses polysomnography (PSG) to record the electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effort, pulse rate, and oxyhemoglobin saturation, depending on the sleep study configuration. The Cerebra Sleep System is for prescription use in a home or healthcare facility. The Cerebra Sleep System is intended to be used as a support tool by physicians and PSG technologists to aid in the evaluation and diagnosis of sleep disorders. It is intended to provide sleep-related information that is interpreted by a qualified physician to render findings and/or diagnosis, but it does not directly generate a diagnosis.

The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. It is for prescription use in a home or healthcare facility and is used by physicians and polysomnographic (PSG) technologists as a support tool to aid in the evaluation and diagnosis of sleep disorders. A PSG tecnologist must edit, score, and review the data before sleep reports are generated. The Cerebra Sleep System is capable of collecting data required for Level 2 PSG and Level 3 HSAT studies. A Level 3 HSAT study is a home sleep apnea test with a minimum of 4 channels that include oxygen saturation, electrocardiogram (ECG) or heart rate, airflow (e.g., nasal flow), and respiratory effort (e.g., chest band). A Level 2 PSG study is an unattended sleep test with a minimum of 7 channels that include electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG) or heart rate, chin electromyogram (EMG), and all signals from Level 3. The Cerebra Sleep System (CSS) is comprised of three main areas: - Prodigy: This is a PSG recorder capable of performing Level 2 and Level 3 sleep studies. It includes the Head Mounted Unit (HMU), which is worn on the patient's head, the Chest Mounted Unit (CMU), which is affixed to a chest effort belt, the Table Top Unit (TTU), which receives data wirelessly, and third party accessories including an oximeter. - Cerebra Analytics Suite (CAS): The CAS has 4 components Web Processing (for signal processing of data), Web Scoring (for generating scoring results, which encompasses autoscoring), Cerebra Viewer (for viewing and editing PSG studies and scoring results) and Web Reporting (for generating reports). A PSG technician must edit, score, and review the data before reports are generated. These components utilize well-defined file formats to enable communication; communication with each component is done through the internet, via the Cerebra Portal. - Cerebra Portal: All areas of the CSS product are managed by the Portal software. The Portal is used to configure a study on the TTU and allows sleep analysis service providers to manage inventory, patients, and sleep studies. It also configures Prodigy system hardware for an individual sleep study to be performed by a patient.

The SOMNOscreen® plus is a non-life-supporting portable physiological signal recording device intended to be used for testing adults and children (age 2 to 12 years)/adolescents (age 12 and above) suspected of having sheep related breathing disorders.

The SOMNOscreen® plus is a modular system with the following components available .: Thermistor, Nasal Canula, Effort belts with respective sensor, SpO2-Sensor, Microphone, Headbox (EXG Channels), external body position sensor, shoulder belts, activity sensor, EMG-PLM sensor, pressure sensor, gold cup electrodes and LoFlo CO2-module (optional). The SOMNOscreen® plus device provides 13 AC channels (10 Referential and 3 Differential), 11 Respiratory and AUX Channels, and 8 Internal Channels. The SOMNOscreen plus is available in 4 different configurations. - . Cardio-RESP - Home Sleep - PSG . - . EEG 32 The purpose of this 510(k) submission is to expand the patient population to include children and adolescents. For the use in pediatric patients the DOMINO software only allows manual (visual) scoring by qualified RPSG. There is no automated analysis or highlighting available for pediatric patients.

The Cadwell ApneaTrak device is intended for home sleep testing, including the acquisition of physiological and environmental data. The recorded signals are then transmitted to a PC so that they can be viewed. ApneaTrak is intended for use on patients older than 2 years of age. ApneaTrak is intended for use in hospitals, sleep centers and other sleep testing environments, including the patient's home. ApneaTrak is intended to be used when prescribed by a qualified healthcare provider for use on patients suspected of sleep disorders, specifically Sleep Disordered Breathing (SDB) and requires review by qualified medical personnel. ApneaTrak is NOT intended to perform automatic diagnosis.

Cadwell's ApneaTrak is a sleep diagnostic system consisting of: (1) acquisition hardware that can acquire, record, store, and transfer up to 3 channels of ExG (including EEG, EMG, ECG, and EOG signals) data, 2 respiratory effort channels, 1 thermistor channel, 1 pressure channel, 1 snore channel, and 1 oximetry channel; (2) a host electronic device (typically a PC) capable of running the software as well as charging and interfacing with the acquisition device; and (3) software that allows for device configuration and data download. ApneaTrak is connected, by a clinical user, to a host device via USB cable for initialization. After initialization and having been given instruction on correct clinical use of the device, ApneaTrak is then used by the patient at home. The device acquires and stores physiological and/or environmental data to onboard memory. After use, the device is returned to the clinical user, who connects the device to the host PC. The software downloads and stores data from the device in European Data Format (EDF).

The Serenity Piezo and Serenity Thermocouple Sensors are intended to measure and limb movement and thermal respiratory flow signals, respectively, from a patient for archival in a polysomnography study. The sensors are accessories to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders. The Serenity Piezo and Serenity Thermocouple Sensors are intended for use on both adults and children by healtheare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under the direction of a medical professional. The Serenity Piezo and Serenity Thermocouple Sensors are not intended for the life monitoring of high risk patients, do not include or trigger alarms, and are not intended to be used as a critical component of: - an alarm or alarm system; - · an apnea monitor or apnea monitoring system; or - · life monitor or life monitoring system.

Serenity sleep sensors are intended to measure and output physiologic signals used for Polysomnography (PSG) or Sleep Studies. These devices are to be used as an accessory to compatible amplifiers. Typical sleep amplifiers use sensors and electrodes to collect physiological signals to further digitize, and the amplifiers send these signals to a host PC. Serenity sleep sensors are worn by the patient and connected directly to compatible inputs of an amplifier. The amplifier and related software then processes the signal for review by qualified practitioners to score polysomnograms and diagnose Sleep Disorders. The Serenity Piezo Sensor uses an embedded piezo sensing element to detect the vibrations of snoring or to sense a patient's limb movement. The sensor outputs a signal which corresponds to movements of the limbs or snore vibrations. The Piezo sensor can be placed on the skin or worn in a heel strap. The Serenity Thermocouple Sensor uses thermocouple wire that is ioined together to form sensing elements. Thermocouple junctions under each nostril and in front of the mouth output a signal which corresponds to the patient's thermal airflow. The Serenity Thermocouple sensor is available with an optional cannula hanger to aid in patient usability when worn with an airflow pressure cannula.

The Serenity RIP and Serenity Body Position Sensors are intended to measure and output respiratory effort signals and body position, respectively, from a patient for archival in a polysomnography study. The sensors are accessories to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders. The Serenity RIP and Serenity Body Position Sensors are intended for use on both adults and children by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under the direction of a medical professional. The Serenity RIP and Serenity Body Position Sensors are not intended for the life monitoring of high risk patients, do not include or trigger alarms, and are not intended to be used as a critical component of: - an alarm or alarm system; - · an apnea monitor or apnea monitoring system; or - · life monitor or life monitoring system.

Serenity sleep sensors are intended to measure and output physiologic signals used for Polysomnography (PSG) or Sleep Studies. These devices are to be used as an accessory to compatible amplifiers. Typical sleep studies use sensors and electrodes to collect, digitize, and send physiological signals to a host PC. Serenity sleep sensors are worn by the patient and connected directly to compatible inputs of an amplifier. The amplifier and related software then processes the signal for review by qualified practitioners to score polysomnograms and diagnose Sleep Disorders The Serenity Body Position uses a 3-axis accelerometer to track the patient's body orientation; outputting a voltage which corresponds to one of 5 positions (sitting/upright, supine, prone, left-side, and rightside). The Serenity RIP Sensor uses respiratory inductance plethysmography to output a waveform which corresponds to patient's respiratory effort. The patient wears an adjustable elastic belt which connects to the RIP driver, the RIP driver then connects to the host device. The Serenity RIP sensor is available for both thorax and abdomen. Thorax and abdomen versions are identical, except that they operate at different frequencies to avoid interference.

This software is intended for use by qualified research and clinical professionals with specialized training in the use of EEG and PSG recording instrumentation for the digital recording, playback, and analysis of physiological signals. It is suitable for digital acquisition, display, comparison, and archiving of EEG potentials and other rapidly changing physiological parameters.

The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd. (XLTEK) Grass® TWin ® (Grass TWin) is a comprehensive software program intended for Electroencephalography (EEG), Polysomnography (PSG), and Long-term Epilepsy Monitoring (LTM). TWin is incredibly powerful and flexible, but also designed for easy and efficient day-to-day use. Grass TWin is a software product only, and does not include any hardware.

The Zmachine Synergy is an EEG and respiratory signal recorder. The device is intended for use by adult patients in the home or clinical environment, under the direction of a qualified healthcare practitioner, to aid in the diagnosis of sleep disorders.

The Zmachine Synergy system is a portable, battery operated, medical device housed within an ABS enclosure. The system combines the single-channel EEG recording capability of the Zmachine DT-100 (K101830) with the respiratory signal recording capability of the Resmed ApneaLink Air (K143272). The Zmachine Synergy is thereby capable of recording EEG, respiratory airflow, respiratory effort, blood oxygen saturation, pulse rate, and body position during sleep.