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DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment of various sleep disorders. The recordings to be analyzed by DeepRESP can be performed in a hospital, patient home, or an ambulatory setting. It is indicated for use with adults (22 years and above) in a clinical environment by or on the order of a medical professional. DeepRESP is intended to mark sleep study signals to aid in the identification of events and annotation of traces; automatically calculate measures obtained from recorded signals (e.g., magnitude, time, frequency, and statistical measures of marked events); infer sleep staging with arousals with EEG and in the absence of EEG. All output is subject to verification by a medical professional.

DeepRESP is a cloud-based software as a medical device (SaMD), designed to perform analysis of sleep study recordings, with and without EEG signals, providing data for the assessment and diagnosis of sleep-related disorders. Its algorithmic framework provides the derivation of sleep staging including arousals, scoring of respiratory events and key parameters such as the Apnea-Hypopnea Index (AHI). DeepRESP is hosted on a serverless stack. It consists of: - A web Application Programming Interface (API) intended to interface with a third-party client application, allowing medical professionals to access DeepRESP's analytical capabilities. - Predefined sequences called Protocols that run data analyses, including artificial intelligence and rule-based models for the scoring of sleep studies, and a parameter calculation service. - A Result storage using an object storage service to temporarily store outputs from the DeepRESP Protocols.

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.

Aluna 2 is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.

Aluna 2 consists of three main components: - A small hand-held peak flow meter that captures differential pressure, converts it to digital data points, and transmits the data to a mobile device via Bluetooth. - A mobile application that collects and transmits the differential pressure readings from the spirometry device and processes it to estimate the exhaled air flow rate and volume. - An Application Programming Interface (API) to facilitate communication with a cloud server used for data storage.

Aluna is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for children 5 years of age or older, adolescent and adult subjects. Additionally, the device may be used by clinicians for in-office monitoring.

Aluna is a small hand-held peak flow meter that captures lung health information and makes it available through a mobile application. Aluna is intended for monitoring FEV1 (Forced Expiratory Volume in one second) and PEF (Peak Expiratory Flow) for over-the-counter use. Aluna is designed for use by pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.

The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake. The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of user/pre-defined reports based on subject's data. The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including patient's home.

The Nox Sleep System is intended for patients undergoing physiological measurements, for the assessment of sleep quality and the screening for sleep disorders. The Nox Sleep System does not provide any alarms and is not intended to be used for continuous monitoring where failure to operate can cause injuries or death of the patient. The basic Nox Sleep System consists of two recording/acquisition devices (Nox A1 Recorder and Nox C1 Access Point), a software running on a PC (Noxturnal PSG), an Android application (Noxturnal App) running on mobile platform, along with sensors and accessories. The system supports full Polysomnography (PSG) studies both in ambulatory and online/attended setups but also more simple sleep study setups, recording only few channels. The ambulatory sleep studies may take place in the clinic or in the home environment, but the online/attended sleep studies are only conducted in the clinical environment. The Nox A 1 Recorder is a small battery-operated recording unit that is worn by the patient during the study. It records signals from patient applied sensors that connect to the unit but also supports recording of signals from auxiliary devices over Bluetooth. The Nox A1 Recorder allows for communication over Bluetooth with the Noxturnal App during ambulatory setup and with the Nox C1 Access Point during online setup. The recorder is intended to be worn over clothing. New accessories and sensors as part of this submission are the Nox A 1 EEG 5 Lead Gold Electrode Cable and Nox A1 EEG Head Cable that are used for recording of EEG/EOG. These components are in direct contact with the patient. The Nox C1 Access Point is a separate mains powered unit located remotely from the patient that allows for recording of signals from auxiliary devices. It supports communication over LAN/Ethernet to the Noxturnal PSG, and communication with the Nox A1 Recorder and Noxturnal App over Bluetooth. The Nox C1 Access Point is only used for online study setup and is thus not intended to be used in the home environment. The Noxturnal App is used as a mobile interface to the Nox A1 Recorder and Nox C1 Access Point. The communications are via Bluetooth link. The app is normally used in the beginning of a sleep study, for basic tasks such as device configuration, starting a recording, checking the signal quality of signals being recorded and marking events during bio calibration. The Noxturnal PSG is used for configuration of the Nox recording/acquisition devices, to download a study from ambulatory recording or to collect an online study. The software supports the viewing, retrieving, storing and processing of data recorded/collected, manual and automatic analysis and reporting on the results from the recorded studies. The purpose with the automatic scoring function in Noxturnal PSG is to assist the trained physician in the diagnosis of a patient. It is not intended to provide the trained physician with a diagnostic results. The type of automatic analysis events scored by Noxturnal PSG include: Sleep Stages (Wake, N1, N2, N3, REM), Apneas, Hypopneas, Apnea Cassification (Obstructive, Mixed and Central Apneas), Limb Movements, Periodic Limb Movements, SpO2 Desaturation Events. and potential Bruxism-Related Events. The result of the automatic analysis/scoring must always be manually verified by the trained physician prior to diagnosis.

The Nox RIP Belts are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. The Nox RIP Belts are indicated for use on patients greater than 2 years of age. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient 's home. The RIP Belt Cables are intended to interconnect Nox RIP belts (respiratory effort sensors) and Nox sleep devices, to allow measuring of respiratory effort signals. The RIP Belt Cables are indicated for use on patients greater than 2 years of age. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient´s home. The Third Party RIP Belt Cables are intended to allow measuring of respiratory effort signals by interconnecting Nox RIP belts (respiratory effort sensors) and sleep devices with oscillation circuitry capable of measuring inductance between 1 and 5 µH. The Third Party RIP Belt Cables are indicated for use on patients greater than 2 years of age. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home.

The Nox RIP Belts are respiratory effort sensors that are intended to function as an accessory with sleep/polysomnography (PSG) systems. The RIP Belts measure respiratory effort signals based on Respiratory Inductance Plethysmography (RIP) technology, which is the gold standard technology for respiratory effort belts. Two RIP belts are used to measure the respiratory effort of the patient. One belt is placed around the patient's abdomen and the other around the patient's thorax. Both abdomen and thorax belts are identical. The Nox RIP Belt Cables are used to connect between the respiratory effort sensor (RIP belts) and the applicable sleep recorder/polysomnography (PSG) system. There are two product groups for the Nox RIP Belt Cables; RIP Belt Cables and Third Party RIP Belt Cables. The RIP Belt Cables are designed for use with Nox recorders only. Those are abdomen cables only because the thorax belt is attached directly to the Nox recorders. The Third Party RIP Belt Cables are designed for use with third party recorders. The Third Party RIP Belt Cables come in pairs for abdomen and thorax.

The QDC-PRO device is a sensor unit intended for measuring of physiological signals during sleep. The signals measured are processed in the QDC-PRO device and the resulting signals made available at the output connector for acquisition by a 3rd party polysomnography (PSG)/sleep recorder. The QDC-PRO device is indicated for use in patients greater than 2 years of age. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments.

The ODC-PRO device is intended to function as an accessory for 3rd party PSG systems, delivering the respiratory signals needed in PSG studies along with position/activity signals. Polysomnography (PSG) is a multi-parametric sleep study indicated for diagnosis of various sleep disorders. The ODC-PRO is therefore a part of a full PSG, the gold standard sleep study, and its main objectives is to provide signals used for diagnoses of sleep disordered breathing (SDB). The signals measured by the ODC-PRO are provided as analog signals to a general 3rd party PSG amplifier that has DC inputs with characteristics matching the QDC-PRO device signal output specifications. The output signals include: - Abdomen respiratory effort (RIP) . - . Thorax respiratory effort (RIP) - . SUM of abdomen and thorax respiratory effort (RIP) - Nasal pressure from nasal cannula . - Snore signal from nasal cannula . - . Body position - . Activity - Audio . The respiratory effort is measured by the use of respiratory inductive plethysmography (RIP). The QDC-PRO device provides calibration for the RIP signals by the use of Quantitative Diagnostic Calibration (QDC) technique. The calibrated RIP signals (Sum) represents the tidal volume of the respiration better than un-calibrated RIP signals. The QDC-PRO contains a sensor unit, respiratory effort sensors (RIP belts) and cables. The QDC-PRO is worn by the patient. It measures signals from two respiratory effort sensors, audio via an inbuilt microphone, nasal pressure and snoring via a nasal cannula and patient 's position/activity data. The signals are processed within the device and the resulting signals made available at the output connector for acquisition by a 3rd party polysomnography (PSG)/sleep recorder. The QDC-PRO is powered with one AA (1.5V) battery and has a display for status indication, signal integrity, and buttons for control.

The Nox T3 device is intended for ambulatory recording of physiological signals during sleep. The recorded signals are then downloaded to a PC where the signals can be viewed and analyzed by use of the Nox T3 application (Noxturnal). The Nox T3 system is indicated for use in patients greater than 2 years of age. The Nox T3 system is NOT intended for any patient monitoring or automatic diagnosis. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient's home. The Nox T3 system is used for patients suspected of suffering from Sleep Disordered Breathing (SDB) or Periodic Limb Movement Disorder (PLMD).

The Nox T3 is an ambulatory recording system. It includes a recording device, respiratory effort sensors, clip straps, filter tube connector and an USB cable for data download and the Nox T3 application (Noxturnal). The Nox T3 device is a pocket size battery powered digital recorder that incorporates electronics to record and store up to three nights of physiological parameters. The Nox T3 device is worn on the patient's chest by snapping it to the thoracic respiratory effort sensor belt and securing its position with the clip straps. It has a display for status indication, signal integrity and preliminary results, and buttons for control. The Nox T3 device records signals from five external sensors and three built-in sensors. The external sensors that can be used with the device are abdominal and thoracic respiratory effort sensors, oximeter (via wireless transmission), and two leads of the following: ECG, EMG, EEG or EOG. The built-in sensors include a pressure transducer allowing either recording of nasal pressure (via nasal cannula) or mask pressure and measuring of snoring, a three dimensional acceleration sensor for measure of patient's position and activity, and a microphone for true audio recording capabilities. The Nox T3 device includes a class II Bluetooth transmitter/receiver to allow for wireless transmission of data from Nonin´s Model 4100 Patient Oximeter Module. The Nox T3 application (Noxturnal) is used to configure the device for recording, and downloading, viewing and analyzing of recorded data on a PC.

The ViaNOx Delivery System is a nitric oxide administration device intended to add nitric oxide to gases that are to be breathed by a patient, and to be used in conjunction with a ventilator or other breathing system. The ViaNOx includes a nitric oxide, nitrogen dioxide, and oxygen monitor intended to monitor the concentration of these gases in respiratory gas mixtures during administration of nitric oxide.

The ViaNOx Delivery System controls the delivery of pharmaceutical grade NO/N2 into the breathing gas stream passing down the inspiratory limb of a patient circuit. The injected flow of NO/Nz is controlled to maintain a steady concentration of NO/Nz within the inspiratory limb at all times, both during and between breaths. Constant concentration operation is accomplished by continuously measuring the flow in the inspiratory limb and adjusting the injected NO/N2 flow rate accordingly. The measure and adjust process is very rapid, and thus provides essentially immediate tracking of changes in the inspiratory flow rate and pattern. The device consists of a cart, a gas plumbing connecting the gas supply to the device, a manual NO delivery system for use with a user supplied manual resuscitator and oxygen supply. a control panel, an NO Delivery Module and the main unit which houses the electronics and most of the software and to which all other components connect.

The ViaNOx Delivery System is a nitric oxide administration device intended to add nitric oxide to gases that are to be breathed by a patient, and to be used in conjunction with a ventilator or other breathing system. The ViaNOx includes a nitric oxide, nitrogen dioxide, and oxygen monitor intended to monitor the concentration of these gases in respiratory gas mixtures during administration of nitric oxide.

The ViaNOx Delivery System controls the delivery of pharmaceutical grade NO/N2 into the breathing gas stream passing down the inspiratory limb of a patient circuit. The injected flow of NO/N₂ is controlled to maintain a steady concentration of NO/N₂ within the inspiratory limb at all times, both during and between breaths. Constant concentration operation is accomplished by continuously measuring the flow in the inspiratory limb and adjusting the injected NO/Nz flow rate accordingly. The measure and adjust process is very rapid, and thus provides essentially immediate tracking of changes in the inspiratory flow rate and pattern. The device consists of a cart, a gas manifold connecting the gas supply to the device, a manual NO delivery system for use with a user supplied manual resuscitator and oxygen supply, a control panel, an NO Delivery Module and the main unit which houses the electronics and most of the software and to which all other components connect.