Intended Use
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Intended medical indication:
NeoBeat and NeoBeat Mini are intended to measure the heart rate of a
newborn within the first few hours after delivery.
NeoBeat is intended for use on newborns approximately 1.5 – 5 kg
(3.3 – 11 lb) and NeoBeat Mini for newborns 0.8 – 2 kg (1.7 – 4.4 lb).
NeoBeat and NeoBeat Mini are intended to be in contact with the intact
skin of the newborn's torso.
Intended users:
Healthcare professionals trained in newborn resuscitation.
Operating principle:
A battery powered monitor placed on the torso of a newborn to measure
and present the heart rate. Dry electrodes on each arm of the device are
placed on opposite sides of the patient's torso to pick up an ECG based
signal.The signal is analyzed by a QRS detection algorithm, and heart rate
is displayed.