Origins
Holter monitor algorithms are designed to mark abnormal events, such as arrhythmia and ST-segment changes, to help doctors efficiently interpret long-term ECG recordings. To verify these algorithms, medical standards require ECG database testing.
Due to the complexity of algorithms that identify ECG abnormalities and their occurrence times, manually comparing test results with reference values can be time-consuming and prone to human error.
To streamline the verification process, we developed the rhythm database comparison software—RDCA (Rhythm Database Compliance Analyzer). After users load the Test Annotation File (TAF) generated by the algorithm to the RDCA, the software automatically compares it with the Reference Annotation File (RAF) at the click of a button.
The RDCA not only displays the match percentage but also allows users to pinpoint the noncompliant time stamps and waveforms by clicking the comparison result, enabling targeted adjustments to the algorithm. Additionally, to prevent significant time differences between the TAF and RAF from affecting comparison results, we have incorporated the "AI Sync" feature, which synchronizes the time stamps of TAF and RAF to avoid inaccurate results due to time misalignment.
For manufacturers seeking to conduct customized tests beyond compliance testing, the RDCA supports importing additional databases. As long as the format and test items of the database are compatible with the RDCA, customized algorithm verification can be performed.
We anticipate that the RDCA will become an essential tool for engineers, helping them refine their algorithms and create more precise ECG devices.
Functions
Select
Rhythm Database Comparison
Supports Digital and Analog Data Input
AI Sync Function for TAF and RAF Time Synchronization
One-click Comparison
Displays Noncompliant Time Stamps and Waveforms
Exports Comparison Results
Includes AHA, MIT-BIH, CU, NST, and ESC databases.
Users can select and download the desired database by clicking the "DB Downloader" button, then perform comparisons on test items such as QRS and VEB.
Capable of comparing the Test Annotation File (TAF) generated from either digital or analog signal tests with the Reference Annotation File (RAF).
Synchronizes the time stamps of TAF and RAF, ensuring more precise comparison results without being affected by time differences.
Simply click the "Start" button to compare TAF with RAF, and the software instantly displays the match percentage.
The comparison results are identical to those obtained using PhysioNet WFDB library software. This eliminates the need for additional database comparison software verification.
Users can easily identify misinterpretations from the algorithm and make necessary adjustments.
The comparison results can be exported in .txt, .csv, Excel, or Word formats.
Highlights
One-Stop Solution for AHA, MIT-BIH, CU, NST, and ESC Rhythm Database Test Annotation File Comparison
- Completes the comparison of TAF and RAF in just two steps: import the TAF and click to perform the comparison; additionally, the RDCA provides noncompliant time stamps, enabling efficient algorithm adjustments
Supports Importing Additional Databases for Customized Testing
- Users can import RAF and TAF from other databases for comparison to verify specially designed algorithms
Note: The "Import Other Databases" feature is available with the "RDCA Enterprise" version.
Comprehensive Compliance Testing Solution
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Saves time studying the medical standard and training by completing performance and database testing required by IEC standards with WhaleTeq ECG testing products
| Category | Detail |
|---|---|
| Supported Standards | IEC 60601-2-47, ANSI / AAMI EC57, YY 0885 |
| Supported Databases | MIT-BIH, AHA, NST, CU, ESC |
| Supported Test Options – 17 Required Capabilities | • QRS Se, QRS +P • VEB Se, VEB +P, VEB FPR • VEB COU Se, VEB COU +P, VEB S_Run Se, VEB S_Run +P, VEB L_Run Se, VEB L_Run +P • RMS heart rate error • % beats missed, % N and S missed, % V missed, % F missed, Total SHUTDOWN time |
| Supported Test Options – 25 Optional Capabilities | • SVEB Se, SVEB +P, SVEB FPR • SVEB COU Se, SVEB COU +P, SVEB S_Run Se, SVEB S_Run +P, SVEB L_Run Se, SVEB L_Run +P • VF EP Se, VF EP +P, VF DU Se, VF DU +P, VF FPR, VF Time • AF EP Se, AF EP +P, AF DU Se, AF DU +P, AF FPR, AF Time • ST EP Se, ST EP +P, ST DU Se, ST DU +P |
| TAF Format | • Binary-MIT annotation (*.atr) • Text-MIT Label (*.txt) • Text-AHA Label (*.txt) • Text-AAMI Label (*.txt) • Text -AHA 2 fields (*.txt) • Text -AAMI 2 fields (*.txt) |
| Supported Time Unit | • Sample Index (100Hz ~ 1500Hz) • Absolute Time |
| Supported Report Export Format | TXT, CSV, Excel, Word |
| Part No. | Description |
|---|---|
| HB0-RDBA099 | Model No.: RDCA Basic Rhythm database comparison software for 17 capabilities of all arrhythmia algorithm requirements |
| HB0-RDPR099 | Model No.: RDCA Pro Rhythm database comparison software for 17 capabilities of all arrhythmia algorithm requirements and optional 25 capabilities |
| HB0-RDEN099 | Model No.: RDCA Enterprise Rhythm database comparison software for 17 capabilities of all arrhythmia algorithm requirements and optional 25 capabilities Supports comparison with other databases* besides AHA, MIT-BIH, NST, CU, and ESC |
◆ The 17 capabilities of all arrhythmia algorithm requirements include QRS, VEB, RMS, and Total SHUTDOWN time. Please refer to item 3 in ''Specification'' for details.
◆ The optional 25 capabilities include SVEB, VF, AF, and ST and exclude HRV. Please refer to item 4 in ''Specification'' for details.
*Note: The capabilities and formats of other databases need to align with those of the RDCA to perform the comparison. For details of capabilities, please refer to item 3 and item 4 in ''Specification''.
Software
Datasheet
User Manual