Description

The S-Patch Cardio App must be connected to an external S-Patch Device in order to collect ECG signals. It is part of a medical grade ECG monitoring solution intended for use in the diagnosis of arrhythmia for patients with suspected cardiac symptoms such as, but not limited to, abnormal heartbeat, lightheadedness, dizziness, chest pain, sweating, pre-syncope, syncope, fatigue, or anxiety.

Disclaimer: The ECG recordings will be submitted to your healthcare provider. Please consult your doctor for further diagnosis and treatment before making any medical decisions.

Jurisdiction Statement: S-Patch Cardio has regulatory clearance in the following regions and countries: Europe (EU, UK, countries that honor CE), Singapore, Vietnam, Thailand, Indonesia, India, Hong Kong, South Korea, Fiji, Australia and New Zealand. The use of S-Patch Cardio is to be prescribed and interpreted only by the accredited physicians or healthcare providers from these regions, or any institutions that are conducting a clinical research with formal IRB approval. The users shall confirm the product regulatory status with their provider.

The overall solution consists of:

a) S-Patch, a single-lead ECG (Electrocardiogram) monitor that continuously measures electrocardiogram (ECG) and heart rate (HR) signals;
b) S-Patch Cardio App installed on a mobile device that receives the live stream of digitized ECG and HR signals from S-Patch; and
c) S-Patch Cardio Portal, a cloud-based analytics platform to which the completed ECG recordings are uploaded and analyzed for further review by the physicians.

* The S-Patch Cardio App requires a unique code from the provider organization in order to be activated. And to initiate the continuous ECG recording it is essential for the App to be paired with the external S-Patch device at all times.

Key features of the S-Patch Cardio App:
- Display incoming ECG stream in real-time
- Calculate and display HR
- Manage Diary (log symptoms and activities)
- Start, Pause and End the ECG Recording
- Send completed ECG recording to a designated cloud platform
- Alert device disconnects

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