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The Prizma device is indicated for home users to measure, record, display and/or transmit ECG one-lead data, heart rate, peripheral oxygen saturation, pulse rate and body temperature data. The device utilizes a mobile platform to initiate user actions (test, display and data transfer by email) through the mobile application. Intended population: adult patients.

The Prizma device described in this submission is based on the cleared Prizma device (K170181), and its physical design has not been modified. The following algorithm functions have been added to the system, thereby extending the indications for use: a) conversion of the previously cleared and reported skin temperature measurement into body temperature b) Pulse rate calculation using the oximeter function. The sensor capabilities of the new Prizma are as follows: - . One lead ECG sensor - ECG rhythm recording and heart rate measurement - . Photo-plethysmography - Peripheral capillary Oxygen Saturation (SPO2) measurement, pulse rate: - . IR thermometer - skin temperature converted into body temperature.

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. Intended population: adult patients.

The Prizma is designed in the form of a Mobile Device jacket. The device consists of: - A sensor unit (Prizma device) embedded with electronics and physiological sensors, in . polycarbonate housing. - 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. - Prizma mobile App, installed on a smartphone, for operating the Prizma device. - A medical power adapter The physiological sensors housed in the Medical Capsule are as follows - One lead ECG sensor, recording + heart rate measurement, derived out of ECG data; ● - Photo-plethysmography, Peripheral capillary Oxygen Saturation (SPO2) measurement; . - Skin temperature thermometer using IR; .