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Prizma G2

Prizma is a mobile, clinical-grade medical device for home use. It is designed in the form of a mobiledevice cover and is intended to record, display, store and share physiological measurements.Users can perform the following medical tests with Prizma:* Electrocardiogram (ECG) – acquiring one lead ECG signal from fingers.* Heart Rate (HR) – derived from ECG Channel.* Peripheral Blood Oxygen Saturation Level (SpO2) – spot-checking from your fingertip.* Skin temperature measurement – intermittent measurement using IR sensor.* Stress test measurement Prizma is intended for home use with specific Android mobile device brands Mobile and Iphone . And ios system.The Prizma product consists of: * Prizma Device - attaches to your compatible mobile device. *A user-supplied compatible Android mobile device.* Prizma App - used to record, view, and share recordings via compatible mobile device (using aWiFi network or your cellular data plan).Patients with known or suspected conditions and health-conscious individuals can use Prizma daily,or whenever they feel symptoms and wish to share their recordings. Patients with ICDs (ImplantedCardiovascular Defibrillators) can use Prizma. Patients with an implanted pacemaker can also usePrizma (in the ECG recording the pacemaker pulse will not be identified).Indications for useThe Prizma device is indicated to measure, record, display, and transmit ECG one-lead data, heartrate, peripheral oxygen saturation and skin temperature data.The device utilizes a mobile platform to initiate user actions (test, display and data transfer by e-mail)through the mobile application. The device does not perform diagnostic functions.Intended population: adult patients.ContraindicationsThere are no known contraindications.
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