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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.

ABPMpro Ambulatory Blood Pressure Recorder is a Non-Invasive oscillometric and ECG device intended to acquire Ambulatory non-invasive Blood Pressure signals and 3 Channel ECG signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. Additional physiological signals like plethysmogram, body position and activity are also measured. The Recorder is intended for adults and children who are over the age of 12 years. ABPMpro Software allows transfer of Blood Pressure-, ECG- and data from additional signals from the Recorder to a Windows-based PC-based computer program via USB cable for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostics evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis.

The ABPMpro is a portable device for recording physiological signals. The ABPMpro is used as a long-term blood pressure as well as a long-term ECG device. The ABPMpro is a portable device worn on the upper arm by means of a cuff and used as an oscillometric 24h ambulatory blood pressure recorder. The ABPMpro consists of the following hardware: ABPMpro recorder with integrated accelerometer and position sensor; Brachial blood pressure cuff (3 sizes available); Optional: 3-channel ECG sensor; Optional: Plethysmogram-sensor (LED). Following the completion of the patient recording session, the device, cuff and electrodes are removed from the patient. The ABPMPro is connected to the PC using the USB cable. With the downloaded ABPMpro Analyzer Software open on the PC, the user can download the recorded data. The user can select the patient data and begin analysis. The device is intended for prescription use.

EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp.

EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans (from the age of 2) under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp. It acts as a conductor between the scalp and the cup electrodes to reduce impedance between the electrode surface and the skin. The reduction in impedance facilitates better recording of the signal. It is intended to be used for up to 10 hours after application to healthy, intact skin. After drying, it is self-adhesive and can be washed off with water. The cream is provided non-sterile and in a 100g aluminum tube. It is white and has no adverse smell. Its texture is smooth and creamy directly after withdrawal from the tube, and solid after drying. EEG-acp is intended to be used as an electroconductive medium between the electrode and the patient's skin, i.e., it amplifies the electrical signal and thereby improves the electrophysiological recording. The high salt content of the cream is responsible for its conductive properties. Its impedance is -1.9 kOhm and its conductivity is 20 mS/cm.

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 SOMNOtouch RESP is a portable physiological signal recorder. It is indicated for use in the recording, displaying, monitoring, printing, and storage of biophysical parameters for the purpose of assisting in the diagnosis of sleep disorders and sleep related respiratory disorders of adult patients. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home. This device is NOT designed to be used in life support situations.

The SOMNOtouch™ RESP is a small, portable physiological signal recording system intended to be used to record, display, monitor, print and store biophysical parameters to aid in the diagnosis of sleep disorders. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home. The SOMNOtouch™ RESP consists of the following: 1. The recording device (worn on the thorax), 2. the finger probe, which is used to detect SpO2, 3. the external effort sensor, 4. two effort belts to measure thoracic and abdominal expansion, 5. the nasal cannula. 6. the Software DOMINOlight for visualization of the recorded data. The SOMNOtouch™ RESP typically will be worn at the thorax, attached by a thorax belt. It contains a sensor to measure the respiratory effort signal of the thorax. The device has an internal accelerometer, measuring body position and motion activity. It provides a connector to attach a nasal cannula, which allows the recording of respiratory flow and snore signals with the internal pressure sensor. Arterial oxygen saturation (SpO2) and pulse rate can be determined via a pulse oximetric finger sensor. Abdominal respiratory effort is measured with an external sensor, attached with a belt to the abdomen. This information is stored in the internal memory of the device. The system provides up to 10 internal channels for data acquisition, Pressure/Flow, Thoracic Effort, SpO2, Pulserate, Snoring, Finger Plethysmogram, Body Position, Movement, Patient Marker, CPAP, and 1 external Abdominal Effort Sensor. The data from all channels can be recorded separately or in any combination with the other channels. Information is stored on an internal 512 MB flash memory and can be transferred to a PC via a USB docking station. The DOMINOlight software retrieves the data from the SOMNOtouch™ RESP, displays and analyzes the data, and can store data for future reference and comparison. The SOMNOtouch RESP does not provide automatic diagnosis and is not designed to be used in Life Support situations.

The SOMNOwatch is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having movement-correlated sleep disturbances.

The SOMNOwatch is a small, portable physiological signal recording system intended to be used to record, display, monitor, print and store biophysical events to aid in the diagnosis of sleep disorders. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home. The SOMNOwatch is a small, typically wrist-worn activity monitor. The device is intended to be used to analyze circadian rhythms, automatically collect and score data for sleep parameters. These parameters, representing the number and intensity of limb movements, are directly associated to movement-correlated sleep disturbances. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desired. For PLM-detection two identical SOMNOwatches may be affixed to the patients legs, one to each leg.

The SOMNOscreen EEG10-20 is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having sleep-related breathing disorders.

The SOMNOscreen EEG10-20 is a portable physiological signal recording system intended to be used to record, display, monitor, print and store biophysical events to aid in the diagnosis of neurologic and sleep disorders. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home.

The SOMNOscreen is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having sleep-related breathing disorders. The SOMNOscreen is indicated for use in the recording, displaying, monitoring, and storage of biophysical parameters for the purpose of assisting in the diagnosis of Neurological and Sleep Disorders.

The SOMNOscreen is a portable physiological signal recording system intended to be used to record, display, monitor, print and store biophysical events to aid in the diagnosis of neurologic and sleep disorders. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home. This device is NOT designed to be used in a Life Support situation. This device is not designed for use on patients with cardiac pacemakers. The system provides up to 28 channels for data acquisition; 10 AC Channels, 8 Referential and 2 Differential, 11 Respiratory and AUX Channels, 7 Internal Channels (SPO2, Pulse Rate, Plethysmogram, Body Position, Light, Patient Marker, Thorax/Abdominal Respiratory Effort) The SOMNOscreen is available in 6 different configurations. All configurations include a Compact Flash Card and Reader, Li ION Batteries, (2000mAh) with 1 x Battery Charger, a Carry Bag for housing the SOMNOscreen and Sensors, Instruction Manuals and the DOMINO software for Initialization, Data Transfer and Analysis.