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Table of Contents

Introducing

This document provides a comprehensive guide covering all necessary information, requirements, and instructions. It serves as a reference to ensure proper understanding and implementation of the provided details.

Table of Contents

  1. Table of Contents

  2. General Information and Requirements

  3. Installation and Setup

  4. Dashboard Overview

    1. User profile management

    2. Organizations overview

    3. Tasks section overview

    4. Users section

    5. Roles section

  5. ECG Viewer Guide

    1. ECG data analysing

    2. ECG data report

Disclaimer

The information provided in this instruction is sourced from a certified document. We strive to ensure accuracy and reliability; however, we recommend referring to the original certified document for official and up-to-date details.

You can download the original certified document here in English: Download PDF.

Download translations in PDF format:

Disclaimer

This translation has been automatically generated using AI. While we strive for accuracy, there may be errors or inaccuracies in the translation. For precise information, please refer to the original text.

Instructions of Use version

Date

Version

Status/revision

07/09/2023

1.0

Document Creation

13/06/2024

1.1

Document update: Smart Actions section added to the document, instructions text has been adjusted.

23/09/2024

1.2

Document update: opening checklist removed, adjusted instruction text after internal reviewing.

28/03/2025

1.3

Document update: added sections "Availability of the Instructions for Use", "Limitations", legal address of the manufacturer clarified.

Document update: added "Latvia", changed the year to 2025 under the first page.

New limitation added.

Software intended use has been changed

IFU symbol has been changed to eIFU.

23/05/2025

1.4

Intended use change. Added sections "Awaiting For Record section overview". Added details of the expected lifetime.

11/07/2025

1.5

Performance characteristics have been formatted.

Manufacturer: XOresearch SIA.

Address: 3, Republikas square, office 107, Riga LV-1010, Latvia

Contact Information: Email: getintouch@xoresearch.com | Phone: +371-67-305-084

Software Identification:

  • Software Name: XOresearch Cardio.AI™

  • Software Version: Version 2.5

  • Class IIa Software under Rule 11 of MDR (EU) 2017/745

  • Basic UDI-DI: 47510473CARDIOAIQE | UDI-DI: 04751047370019

  • Intended Use: XOresearch Cardio.AI™ is a standalone medical device software, using AI algorithms, intended to be used to analyze ECG signal recordings of adult patients by trained healthcare professionals in a clinical environment for the assessment of basic heart rate patterns. The results and interpretations generated by the software are reviewed, modified and approved by the physician. The physician retains full responsibility for the diagnosis and treatment decisions.