Medical Disclaimer
Last updated: July 2026
DSE123 is a clinical workflow tool, not a diagnostic medical device. It has not been cleared or approved by any regulatory authority. All clinical decisions remain the sole responsibility of the treating physician.
Intended Use
DSE123 is intended to serve as a clinical workflow aid for dobutamine stress echocardiography (DSE) studies. It provides structured data entry, automated hemodynamic calculations based on standard formulae, protocol-guided stage management, and formatted PDF report generation. The Application is designed to streamline documentation and reduce calculation errors during stress testing procedures.
Who Should Use DSE123
DSE123 is designed for qualified healthcare professionals with appropriate training and expertise in stress echocardiography, including:
- Licensed cardiologists experienced in stress echocardiography
- Certified cardiac sonographers performing DSE studies
- Cardiology fellows training under supervision in echocardiography
- Other qualified medical professionals with relevant competency
Who Should NOT Use DSE123
The following individuals should not use DSE123 for clinical purposes:
- Patients seeking to interpret their own test results or self-diagnose
- Untrained medical personnel without expertise in stress echocardiography
- Non-medical professionals or members of the general public
- Anyone lacking the clinical context to interpret echocardiographic data
Regulatory Status
DSE123 is NOT approved, cleared, or certified by any regulatory authority, including but not limited to:
- U.S. Food and Drug Administration (FDA)
- European Conformity (CE marking / MDR)
- Central Drugs Standard Control Organisation (CDSCO, India)
- Any other national or international medical device regulatory body
DSE123 is not classified as a medical device, Software as a Medical Device (SaMD), or clinical decision support system under any regulatory framework. It is a general-purpose calculation and documentation aid.
Clinical Responsibility
The treating physician or qualified healthcare provider retains full and sole clinical responsibility for all patient care decisions. DSE123 outputs, including calculations, interpretations, and reports, are supplementary aids and must not replace independent clinical judgment, direct patient assessment, or established institutional protocols.
Users must independently verify all calculations and critically evaluate all generated content before incorporating it into clinical practice or medical records.
Calculation Accuracy
All calculations in DSE123 are based on standard hemodynamic formulae widely accepted in clinical practice. While every effort has been made to ensure mathematical accuracy, no software is immune to bugs or edge cases. Users must:
- Verify calculated values against expected clinical ranges
- Cross-reference critical values with manual calculations when in doubt
- Report any suspected inaccuracies to the developer immediately
Evidence Base
The clinical algorithms, reference values, and grading criteria used in DSE123 are derived from the following peer-reviewed guidelines:
- ASE 2020 — American Society of Echocardiography Guidelines for the Use of Echocardiography in the Evaluation of Valvular Regurgitation and Stenosis
- ASE 2025 — Updated ASE Recommendations for Stress Echocardiography
- ESC/EACTS 2025 — European Society of Cardiology / European Association for Cardio-Thoracic Surgery Guidelines for the Management of Valvular Heart Disease
- ACC/AHA 2020 — American College of Cardiology / American Heart Association Guideline for the Management of Patients with Valvular Heart Disease
Clinical guidelines evolve over time. Users should ensure they are applying the most current evidence-based standards in their practice.
Reporting Issues
If you encounter any errors, inaccuracies, unexpected behavior, or potential safety concerns while using DSE123, please report them immediately to:
Dr. Kunal Patankar
drkunalpatankar@gmail.com
Your feedback is critical for maintaining the accuracy and reliability of the tool.