AI-ECG Tracker — Dynamic ECG AI Analysis Software
Instructions for use are supplied in electronic form. The complete instructions for use (IFU) for this device are published on this page. A paper copy is available free of charge upon request — see Request a paper copy below. This page is provided in accordance with Commission Implementing Regulation (EU) 2021/2226.
| Manufacturer | Shenzhen Carewell Electronics CO., LTD. |
|---|---|
| Product name | AI-ECG Tracker |
| Model number | S |
| Document number | 256-200035-00 |
| Document reference | IFU-256-200035-00-V1.0-AI-ECG-Tracker.pdf |
|---|---|
| IFU version | V1.0 Current |
| Release date | 2025-05 |
| File format/size | PDF (PDF 1.7) / 6,011,767 bytes |
| File fingerprint (SHA-256) | 6937689ecd9a6a65ab03b2b287be207b305ee391d15577a8a89f2be6597d6fa6 |
| View/Download | |
| Languages | English (EN) |
If you would like the instructions for use in paper form, or an electronic copy of a version that is not listed above, please contact us. A paper copy will be provided free of charge within 7 calendar days of receiving your request.
| Service contact | Shenzhen Carewell Electronics Co., Ltd. Customer Service Center |
|---|---|
| Tel | +86-755-86170389 |
| Fax | +86-755-86170478 |
| service-intl@carewell.com.cn | |
| Address | Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District 518108, Shenzhen, P.R. China (Zip code: 518108) |
| Please state | Device name, document number 256-200035-00, required version, language, and delivery address |
The PDF opened in the browser and the file obtained with the Download IFU (PDF) button are the same document. Verification is performed on the saved copy: compute its SHA-256 value and compare it with the fingerprint published in section 2. If the two values match, the file is identical to the version released by the manufacturer.
certutil -hashfile "IFU-256-200035-00-V1.0-AI-ECG-Tracker.pdf" SHA256
sha256sum IFU-256-200035-00-V1.0-AI-ECG-Tracker.pdf
The checksum file IFU-256-200035-00-V1.0-AI-ECG-Tracker.pdf.sha256 contains the same fingerprint together with the file name; it can be used directly to verify the download (macOS / Linux: sha256sum -c IFU-256-200035-00-V1.0-AI-ECG-Tracker.pdf.sha256). Both files must be saved in the same folder for this command to work.
The published PDF carries an embedded digital certification signature (PAdES, SHA-256) with permissions set to no changes allowed. Any modification of the file after signing invalidates the signature. Open the PDF in Adobe Acrobat / Acrobat Reader and check the Signature panel: the software reports the signature status and whether the document has been modified since it was signed.