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ANNE Pediatric is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, skin temperature, and body temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on neonatal patients of any gestational age up to infants 2 years of age as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended to monitor critically ill patients. The device is not intended to monitor or measure heart rate during motion. The device is not an apnea alarm.

ANNE Pediatric is a wireless vital signs and physiological data monitoring platform that collects electrocardiography (ECG) and temperature biosignals to measure vital signs such as heart rate (HR), skin temperature, and body temperature. The system features two skin-mounted, bio-integrated sensors that pair with the ANNE View application for the display of real-time vital measurements. Data is transmitted wirelessly from the sensors via Bluetooth to the mobile device.

ANNE Sleep is a wearable sensor system intended for use in the collection, and storage of physiological parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use in the clinical and home setting under the direction and interpretation by a Healthcare Professional (HCP).

ANNE Sleep is a wireless physiological recorder for use as an aid in the diagnosis of sleep-related breathing disorders by healthcare professionals. The system features two skin-mounted, biointegrated sensors that pair with an associated proprietary software application for the transmission and storage of data. The sensors, which are placed on the chest and finger, measure peripheral arterial tonometry (PAT), oximetry (SpQ2), pulse rate, snoring, chest movement, body position, total sleep time, and heart rate. These data are uploaded to a cloud backend that can communicate with a compatible third-party software viewer, where they are reviewed by a qualified healthcare professional to identify sleep-disordered breathing events according to a scoring manual. The number of sleep-disordered breathing events per hour of sleep is the Sibel-AHI, a parameter that functions as an aid to diagnosis of sleep apnea by physicians. A sleep report is generated from this score and uploaded to a web portal, the ANNE Sleep Hub, where it can be stored and further reviewed.

ANNE One is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, respiratory rate, step count, fall count, skin temperature, and body temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended for use on critical care patients. The device is not intended to monitor or measure respiratory rate or heart rate on ambulatory patients.

ANNE One is a wireless multi-parameter vital signs monitoring system that consists of the following components, and subsystems: A. ANNE Tablet (Samsung Galaxy Tablet) - manufactured by Samsung B. ANNE View Mobile Application (software) manufactured by Sibel Inc. C. ANNE Chest Sensor manufactured by Sibel Inc. D. ANNE Limb Sensor manufactured by Sibel Inc. E. ANNE Wireless Charger manufactured by Sibel Inc. The ANNE Chest Sensor is a battery-operated, skin-mounted sensor with wireless transceiver capabilities worn on the upper body to measure heart rate, respiratory rate, step count, fall count, and skin temperature. The ANNE Limb Sensor is an additional battery-operated skin-mounted sensor with wireless transceiver capabilities worn on the finger to measure skin temperature. When placed underneath the axillae, the ANNE Limb Sensor can measure body temperature. Both the ANNE Chest and ANNE Limb Sensors continuously gather vital signs data from the person being monitored and then transmit the encrypted data to the ANNE Tablet operating the ANNE View Mobile Application-a mobile device software application.