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General Information and Requirements

Introduction

Welcome to the Instruction for Use (IFU) for XOresearch Cardio.AI. This document is provided by XOresearch SIA to assist healthcare professionals in safely and effectively utilizing our clinical decision support software.

The IFU contains essential information about the software\'s features, its intended use, precautions, and guidance on troubleshooting. Please read this document carefully before using the software.

Software Description

Cardio.AI is a multipurpose device for automatic annotation and interpretation primarily long, and short (from 7 seconds to 35 days) ECG records with any lead combinations and designed to:

  • detect heartbeats, in pre-recorded ECG data; and separate noise from the beats in the data analysed by the device; and

  • detect beat and rhythm events for the following rhythms: sinus, atrial, junctional, ventricular; and for the following disorders: pre-excitation syndromes, heart blocks; and for bundle branch blocks; and

  • detect PQRST points, ST segment amplitude and direction, T-wave type, HRV, Heart Rate BPM; and

  • visualise ECG data along with the other vital signs and patient-related information such as indications, diary events, demographic data; and

  • generate an interpretation statement on an ECG data; and

  • create a report based on the ECG findings in export it in a PDF format alongside priority indicators labelling; and

  • store ECG data in cloud storage; and

  • provide temporary or permanent access to ECG data or other vital signs.

The annotation by the device may be confirmed, edited, or deleted by the physician. Platform interpretation results are not intended to be the sole means of diagnosis.

XOresearch CardioAI is a multipurpose medical device designed by the manufacturer to serve the following clinical purposes:

Automatic Annotation and Interpretation: The primary function of this device is the automatic annotation and interpretation of primarily long and short ECG records, irrespective of lead combinations.

It is specifically engineered to:

Detect Heartbeats: Accurately identify heartbeats within pre-recorded ECG data.

Noise Separation: Distinguish and separate noise from the analyzed heartbeats in the data.

Rhythm Detection: Detect various cardiac rhythms, including sinus, atrial, junctional, and ventricular rhythms.

Disorder Identification: Identify specific cardiac disorders such as pre-excitation syndromes, heart blocks, and bundle branch blocks.

Data Analysis: Analyze critical ECG parameters like PQRST points, ST segment amplitude and direction, T-wave type, Heart Rate Variability (HRV), and Heart Rate in beats per minute (BPM).

Comprehensive Visualization: Display ECG data alongside vital signs and patient-related information, including indications, diary events, and demographic data.

Interpretation Generation: Generate an interpretation statement based on the analyzed ECG data.

Report Creation: Create a comprehensive report summarizing ECG findings, exportable in PDF format, with severity indicators labeling.

Cloud Storage: Store ECG data securely in cloud storage for easy access and retrieval.

Data Accessibility: Provide both temporary and permanent access to ECG data and other vital signs as required.

Please note that while the device offers automatic annotation and interpretation, it is crucial to emphasize that these results are not intended to serve as the sole means of diagnosis. Physicians may confirm, edit, or delete annotations made by the device as part of their clinical evaluation.

This clearly defined intended purpose aligns with the manufacturer\'s specifications and serves as the foundation for establishing the necessary requirements applicable to the device. It is essential that this intended purpose remains consistent across all relevant documents and technical documentation.

Indications for Use

XOresearch Cardio.AI is intended for use in a hospital or clinical setting, by or on the order of a physician or similarly qualified health care professional. XOresearch Cardio.AI evaluates the ECG data of ambulatory patients pre-recorded with a legally marketed digital ECG recorder with any lead combinations.

The annotation by the device may be confirmed, edited, or deleted by the physician. The final decision regarding the treatment of patients is the responsibility of the physician.

XOresearch Cardio.AI intended to be used on adult patient records (over the age of eighteen).

Contraindications

XOresearch Cardio.AI is not indicated to detect pacemaker, as pacemaker's detection is not part of the current version of the system. XOresearch Cardio.AI does not analyse the pacemaker function and threats the signal as is, without any assumptions on presence or absence of the pacemaker, thus should not be used in fully automatic mode without physician attention for patients with a pacemaker.

XOresearch Cardio.AI does not support online real time analysis of ECG data. XOresearch Cardio.AI processes offline data in post-processing mode.

XOresearch Cardio.AI is not intended for real-time patient monitoring.

Intended users

XOresearch Cardio.AI is intended for use by medical professionals, such as those who are responsible for deciphering ECG data, analyzing it, and diagnosing the patient on the basis of this data.

Precautions

  • Ensure that your computer system meets the minimum system requirements specified in the software\'s documentation. Inadequate hardware or software configurations may result in performance issues or software malfunctions.

  • Verify the accuracy of input data, as inaccurate or incomplete data may lead to incorrect recommendations.

  • Use the software in a controlled clinical environment with proper lighting and minimal distractions to minimize the risk of errors.

  • Always exercise sound clinical judgment when interpreting the software\'s recommendations. The software is a decision support tool and should not replace the expertise of healthcare professionals.

  • Do not rely solely on the software\'s recommendations for critical or life-threatening decisions. In such cases, seek immediate clinical assessment and intervention.

  • Report any software-related issues, errors, or discrepancies to the appropriate personnel or IT support to address and resolve them promptly.

  • Ensure that healthcare professionals using the software are adequately trained and competent in its use. Training should cover software operation, data input, result interpretation, and troubleshooting.

Warnings

  • Do not solely rely on the software\'s recommendations; use clinical judgment.

  • Ensure data input is accurate, as incorrect data may lead to incorrect recommendations.

  • XOresearch Cardio.AI is a decision support tool and is not a substitute for the expertise of trained healthcare professionals. Healthcare providers must exercise their clinical judgment when interpreting software recommendations and making medical decisions.

  • In cases of urgent or critical medical conditions where immediate clinical assessment and intervention are required, do not solely rely on the software\'s recommendations. Delaying necessary actions can have serious consequences.

  • The accuracy of outputs generated by the software depends on the accuracy and completeness of the input data. Users are responsible for verifying the correctness of patient data entered into the system.

  • Healthcare professionals are solely responsible for interpreting and acting upon the software\'s recommendations. Exercise caution and ensure that the recommendations align with the patient\'s clinical presentation and history.

  • Protect patient data and ensure its security during transmission and storage. Unauthorized access or data breaches can compromise patient privacy and confidentiality.

  • Report any software-related errors, discrepancies, or unusual behaviors to your organization\'s IT support or the software provider. Do not attempt to modify or alter the software without proper authorization.

  • The software provider and manufacturer disclaim liability for any adverse events or consequences arising from the use of XOresearch Cardio.AI beyond the extent permitted by law. Healthcare professionals are responsible for their decisions and actions.

Technical Requirements

  • XOresearch Cardio.AI is accessible through a web browser. It is recommended to use the latest version of Google Chrome for optimal compatibility and performance. The minimum required of the last stable version Google Chrome (now is 116).\ Note: while other modern web browsers may also work, Google Chrome is the recommended browser due to its tested compatibility with the software.

  • A stable and high-speed internet connection is essential for accessing XOresearch Cardio.AI. A minimum download and upload speed of 100Mbit/s is recommended.

  • Ensure that network firewall and security settings allow access to the XOresearch Cardio.AI web application. It may be necessary to whitelist the following domains to ensure unobstructed access: https://web.cardio.ai/

Data Input and Output

Data Input:

  • Cardio.AI accepts ECG file data in the following format: EDF, SCP.

  • Ensure that all input data is accurate and complete;

Data Output:

  • XOresearch Cardio.AI generates reports based on analysed ECG data and displays it on the screen on purpose. The user is enabled to export this report as a PDF report for sharing with other healthcare professionals.

User Authentication and Access Control

User Authentication: Each authorized user is required to log in using their unique username and password. It is essential to keep login credentials confidential. Login credentials are being provided by the XOresearch SIA directly, via the contact email, or via the contact webform under Cardio.AI website.

Access Control: The software offers role-based access control, ensuring that users only have access to the features and patient data relevant to their role. Administrators can manage user permissions.

The following roles and permissions are provided as default with the organization:

Role name

Role permissions

Uploader

  • Upload ECG records;

  • Create tasks based on uploaded ECG records;

  • Manage metadata for the created tasks;

  • View only the created tasks;

ECG Editor

  • Upload ECG records;

  • Create and manage tasks based on uploaded ECG records;

  • View, edit ECG, create, manage and export reports for the ECG tasks within the organization;

  • Manage metadata for the tasks within the organization.

Admin

  • Upload ECG records;

  • Create and manage tasks based on uploaded ECG records;

  • View, edit ECG, create, manage and export reports for the ECG tasks available within the organization;

  • Manage metadata for the tasks within the organization;

  • Manage users, roles and permissions within the organization.

Support

  • Upload ECG records;

  • Create and manage tasks based on uploaded ECG records;

  • View, edit ECG, create, manage and export reports for the ECG tasks available within the organizations;

  • Manage metadata for the tasks within the organizations;

  • Manage users, roles and permissions within the organization;

  • Managing the organizations, users, roles and permissions within the software.

Note: allocation of \'customizable\' permissions is the responsibility of the health institution\'s admin.\ The Support role is intended to be used only by the XOresearch Cardio.AI staff members.

Data Security and Privacy

XOresearch SIA places the utmost importance on the security and privacy of patient data. We employ industry-standard encryption protocols to ensure the confidentiality and integrity of patient data during both transmission and storage. Additionally, our software complies with all relevant data privacy regulations, including but not limited to the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA). These measures are in place to safeguard patient privacy and data security.

Additional User Security Recommendations:

In addition to the security measures we have implemented, we strongly recommend that users take the following steps to enhance cybersecurity while using XOresearch Cardio.AI:

Keep Your Login Information Secure: Never share your login credentials, and ensure they remain confidential. Avoid writing down login information or storing it near your computer.

Regularly Change Your Password: Change your password at the first login and periodically thereafter. Use strong passwords that include a minimum of 8 characters, comprising special characters, numbers, uppercase letters, and lowercase letters.

Avoid Common Passwords: Refrain from using easily guessable passwords, such as simple combinations or common words. Never use the same password for multiple devices or accounts.

Verify Website URLs: Always verify the URL address before logging into any site. Secure websites start with \"https,\" and a green lock symbol should be displayed in the URL bar.

Install Antivirus and Antispyware Software: Protect your computer by installing and regularly updating antivirus and antispyware software.

Report Suspicious Activity: If you notice any unexpected behavior on your system while using XOresearch Cardio.AI, please contact our support team. If necessary, we will notify you via email and/or our website if the system faces potential threats that require downtime for resolution.

Continuous Improvement and User Notifications:

As part of our commitment to security, we continuously monitor cybersecurity threats and make necessary improvements. We will keep you informed of software updates, revisions, or additional security measures through email notifications, ensuring that you have access to the latest safeguards and enhancements.

Troubleshooting

If you encounter technical issues or unexpected errors while using XOresearch Cardio.AI, please contact our technical support team at getintouch@xoresearch.com.

Manufacturer's Declaration

We, XOresearch SIA, declare that this Instructions for use accurately represents the use and troubleshooting procedures for XOresearch Cardio.AI.

Any serious incident related to the device must be reported to XOresearch and to the competent authority of the Member State in which the users and/or patients are established.