iPhone app S-Patch Ex

The App must connect to an external hardware device called the S-Patch in order to get activated and start collecting continuous ECG signals.
The S-Patch is 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 currently has regulatory clearance in the following region(s): South Korea.
The use of S-Patch 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 a formal IRB (Institutional Review Board) approval.
The users shall confirm the product regulatory status with their provider.

The overall solution consists of:

a) S-Patch, a single-lead ECG monitor that continuously measures electrocardiogram (ECG) and heart rate (HR) signals;

b) S-Patch Ex App installed on a mobile device that receives live stream of digitized ECG and HR signals from S-Patch Ex; and

c) S-Patch Analysis Portal, a cloud-based analytics platform to which the completed ECG recordings are uploaded and analyzed for further review by the physicians.

Key features of the S-Patch Ex 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 on device disconnects

* The S-Patch Ex App requires a unique organization code from the provider 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.,

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