The NightWatch+ US is a prescription only device that is indicated for use as an adjunct to seizure monitoring of children age 4 till 16 diagnosed with epilepsy having Nocturnal Epileptic Major Motor Seizures which includes tonic-clonic (TC), tonic (if clustered or prolonged >30 seconds), hyperkinetic and TC-like seizures, in home or residential facilities during periods of rest. NightWatch+ US consists of a sensor worn during sleep on the biceps of the upper arm and an alarm station. The sensor consists of a heartrate sensor using PPG (photoplethysmography), a ACC (Accelerometry) movement sensor, and a microprocessor. The microprocessor processes the data from the sensors using a detection algorithm which detects if the sensor readings match pre-programmed parameters that are associated with nocturnal epileptic major motor seizures. When a nocturnal epileptic major motor seizures is detected, the seizure alarm is triggered and transferred from the sensor to the accompanying alarm station which alarms the caregiver by a sound and a blinking LED light. The seizure alarms data can be transferred from the alarm station, using an ethernet connection, to a database in the cloud to be viewed a web-based interface called NightWatch Portal to be able to monitor seizure frequency overtime.The NightWatch+ US is not intended to diagnose specific seizure types.
An assembly of devices intended to detect and record a seizure by continuous measurement of one or more physical/physiological parameters (e.g., body motion, electrical activity of the heart or skeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home; some types may also be used in clinical settings. It typically consists of a mains electricity (AC-powered) central monitor that wirelessly receives, records, and displays the data, and one or more battery-powered body-worn sensor(s); it may have alarms and data may be transmitted to a cloud-based storage, server or mobile device.