S-Patch Ex 12+

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.