• Indications for Use
• Terms of Service
• Privacy Policy
• Privacy Policy (EU)
• Data Use
• Subprocessors
• Cookie Policy
• Data Processing Addendum

Indications for Use

Us2.v1 software is used to process acquired transthoracic cardiac ultrasound images, to analyse and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v1 is indicated for use in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumours, thrombi).

Please note the following limitations:

• Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality.
• Our software complements good patient care and does not exempt the userfrom the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions.
• If no gender is present, female referenced guideline values will be used for conclusions.
• If Body Surface Area (BSA) is not present, indexed values cannot be provided.
• Normal reference values vary with age, sex, and ethnicity. In case of doubt always refer back to the appropriate cardiac society's guidelines.
• During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of EKG capture may lead to lower accuracy of the software.
• Presence of any of the non-validated conditions (congenital heart disease, valve disease, pericardial effusion, and/or intra-cardiac lesions, e.g. tumours, thrombi) may influence measurement accuracy.

This software was manufactured in 2021 by Us2.ai.