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The Apnea Risk Evaluation System (ARES), Model 620 is indicated for use in the diagnostic evaluation by a physician of adult patients with possible sleep apnea. The ARES can record and score respiratory events during sleep (e.g., apneas, hypopneas, mixed apneas and flow limiting events). The device is designed for prescription use in the patient's home to aid a physician in diagnosing adults with possible sleep-related breathing disorders.

The Apnea Risk Evaluation System (ARES™) includes a battery powered patient worn device called a Unicorder (Model 620). The Unicorder is worn by a patient for one to three nights, each night recording up to 7 hours of data. Data recorded includes oxygen saturation, snoring level, head movement, head position, and airflow. Additionally, the Unicorder 620 allows collection of data from ARES compatible peripheral devices. The device monitors signal quality during acquisition and notifies the user via voice messages when adjustments are required. A standard USB cable connects the Unicorder to a USB port on a host computer when patient data is to be uploaded or downloaded. The USB cable provides power to the Unicorder during recharging from the host computer or from a USB wall charger. The Unicorder cannot record nor can it be worn by the patient when connected to the host computer or the wall charger. Software, residing on a local PC or a physical or virtual server controls the uploading and downloading of data to the Unicorder, processes the sleep study data and generates a sleep study report. The ARES™ can auto-detect positional and non-positional obstructive and mixed apneas and hypopneas similarly to polysomnography. It can detect sleep/wake and REM and non-REM. After the sleep study has been completed, data is transferred off the Unicorder is prepared for the next study. The downloaded sleep study record is then processed with the ARES ™ Insight software to transform the raw signals and derive and assess changes in oxygen saturation (SpO2), head movement, head position, snoring sounds, airflow, and EEG or respiratory effort. The red and IR signals are used to calculate the SpO₂. The actigraphy signals are transformed to obtain head movement and head position. A clinician can convert an auto-detected obstructive apnea to a central apnea based on visual inspection of the waveforms. ARES "" Screener can predict pre-test probability of obstructive sleep apnea (OSA). The ARES "" data can also assist the physician to identify patients who will likely have a successful OSA treatment outcome, including CPAP and oral appliance therapies. ARES™ can help identify patients who would benefit from a laboratory PAP titration.

Clinical Application's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Additionally, it can send configuration information to Watermark home monitoring devices. Watermark devices include the Connected Care Mobile Application and MiPal. The configuration information may include a patient's vitals collection schedule and parameters to be collected. The Clinical Application displays the data and system alerts for review and interpretation by a healthcare professional. The Clinical Application is not intended for emergency use or real-time monitoring.

The Connected Care Clinical Application is a cloud based, web software system. It is accessed from commercially available PC systems with a web browser and minimum performance specifications consistent with typical PC hardware and equipment specifications. The Clinical Application accepts data from Watermark Patient Monitors. The Connected Care Clinical Application is a medical device data system that receives, stores, and displays data received from Watermark home monitoring devices. Additionally, it can send configuration information to Watermark home monitoring devices. Watermark devices include the Mobile Application and MiPal. The configuration information may include a patient's vitals collection schedule and parameters to be collected.

Mobile Application allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions by qualified health care professionals. The Mobile Application is intended for use with adult and pediatric patients over twelve years of age.

The Connected Care Mobile Application is intended to receive, display and transmit patient information on a retrospective basis. The device is not intended for real-time monitoring or emergency use by patients or caregivers. The mobile application is designed to operate on various platforms including tablet computers and smart phones, guiding a user through the vitals acquisition process via Bluetooth medical peripherals. Peripherals will include: - . Scale - Glucose meter - NiBP . - . SPO2

MiPal allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions by qualified health care professionals. It is not intended for real-time, emergency, or critical care monitoring of patient vital signs. The MiPal is intended for use with adult and pediatric patients over twelve years of age. SpO2 is to be used under the direction of licensed health care professionals, and is available only by or on the order of a physician.

The MiPal is a communication hub intended to receive and transmit patient information on a retrospective basis. The device is not intended for real-time monitoring or emergency use by patients or caregivers. The MiPal is designed to optionally collect NiBP, pulse, and SpO2. It may also collect other vitals through the vitals acquisition process via Bluetooth medical peripherals. Peripherals will include: - Scale - o Glucose meter