DEVICE DESCRIPTION
The Prizma is designed in the form of a Mobile Device jacket. The device consists of: 1) A sensor unit (Prizma device) embedded with electronics and physiological sensors, in polycarbonate housing. 2)A silicone cover to mechanically receive the sensor unit and form a “Jacket” that is attached to the back of the smartphone. Cover design can be modified from one smartphone to another to fit the different dimensions. 3) Prizma mobile App, installed on a smartphone, for operating the Prizma device. 4) A medical power adapter The physiological sensors housed in the Medical Capsule are as follows 5) One lead ECG sensor, recording + heart rate measurement, derived out of ECG data; 6) Photo-plethysmography, Peripheral capillary Oxygen Saturation (SPO2) measurement. 7)Skin temperature - thermometer using IR;
INDICATIONS FOR USE The Prizma device is indicated to measure, record and transmit ECG one-lead data, and to measure, record, display and transmit heart rate, peripheral oxygen saturation and skin temperature data. The device utilizes a mobile platform to initiate user actions (test, display and data transfer by email) through the mobile application. The device does not perform diagnostic functions.
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