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The HANNAH Wireless Vital Signs Monitor is indicated for the continuous monitoring of an infant's heart rate, respiration rate, and occurrences of central apnea in home, hospital and other environments.

The HANNAH system is an infant apnea monitor, which is substantially equivalent to legally marketed devices. The HANNAH system includes features incorporated in legally marketed devices. Like most legally marketed infant apnea monitors, the HANNAH incorporates sensors and alarms for monitoring both breath and heart rate. Like most legally marketed infant apnea monitors, the HANNAH system monitors heart rate using a 3-lead ECG measurement. The HANNAH system has the same technological characteristics as legally marketed devices. Because lead wires connected to the infant present a documented risk for strangulation and electrocution, and because lead wires are the source of a substantial majority of the false alarms associated with wired monitors, the decision was made to use radio frequencies to transmit the monitoring information from infant-placed sensors to the central unit. Further, since the more common method of monitoring, impedance pneumography, is highly susceptible to false readings due to interference with cardiac signals and motion artifacts, respiration is monitored using a pressure sensor instead.