wSmartHeart ECG

Validated by International Authoritative Databases

The performance of ECG technology is primarily assessed by the accuracy and reliability of signal recognition. wSmartHeart® has been rigorously validated using established clinical databases and tested against internationally recognized standards. These evaluations confirm the precision and robustness of its ECG analysis algorithms, aligning with the practices of leading global manufacturers.

• Test Method

wSmartHeart® ECG algorithm performance is evaluated in accordance with the ANSI/AAMI EC57:2012 standard—widely recognized as the gold standard for testing and reporting the accuracy of cardiac rhythm and ST segment measurement algorithms. Compliance with this standard is a prerequisite for FDA approval and requires validation using international authoritative databases.

The EC57 standard focuses primarily on the detection of QRS complexes and ventricular premature beats, with primary testing conducted on the MIT-BIH and AHA ECG databases. Comparative analysis demonstrates that wSmartHeart® achieves detection accuracy at the level of leading global manufacturers.

•Test Results Overview

Key performance metrics include:

• QRS Se: Sensitivity for QRS complex detection• QRS +P: Positive predictivity for QRS complex• V Se: Sensitivity for ventricular ectopic beats (VEBs)• V +P: Positive predictivity for VEBs• V FPR: False positive rate for VEBs

wSmartHeart® ECG technology demonstrates high accuracy in waveform recognition and arrhythmia detection, performing at the level of leading global ECG systems.

• Clinical BenefitswSmartHeart® ECG technology delivers high clinical accuracy, with QRS complex sensitivity at 99.7% and positive predictivity exceeding 99.5%, ensuring precise heart rate calculation. Ventricular ectopic beat (VEB) detection sensitivity exceeds 93%, with a positive predictivity above 96%. These results confirm wSmartHeart® meets first-tier clinical standards for ECG recognition.

Rapid Recovery Technology

In clinical settings, issues such as signal overload, baseline drift, and lead disconnection can disrupt ECG monitoring. Unlike traditional systems that require extended recovery time even after manual intervention, wSmartHeart® integrates hardware optimization with real-time software filtering to restore signal integrity within 3 seconds. This ensures continuous, reliable ECG monitoring in critical situations.

• Implementation PlanIn abnormal clinical scenarios such as lead disconnection or signal overload, the wSmartHeart® system promptly detects anomalies and initiates hardware discharge and lead switching. This prevents sustained voltage overload and enables fast signal stabilization. The system also dynamically adjusts the high-pass filter frequency and employs real-time software filtering to minimize recovery time to under 3 seconds.Combined hardware and software mechanisms ensure that transient signals do not affect downstream processing, enabling rapid, stable, and reliable ECG recovery. The diagram below illustrates signal restoration following lead reconnection.

• Clinical BenefitswSmartHeart® ensures rapid ECG signal recovery under abnormal conditions such as overload, baseline drift, or lead disconnection. This minimizes clinical interruptions, reduces patient risk, and enhances the reliability of continuous cardiac monitoring.

Intelligent Optimal Analysis Lead Technology

This core component of wSmartHeart® ECG technology automatically selects the optimal lead for analysis in real time. It ensures stable and accurate ECG monitoring, even under signal disturbance or lead degradation, maintaining high reliability in clinical environments.

• Implementation Plan

wSmartHeart® employs intelligent lead analysis algorithms that monitor key indicators such as lead-off status, signal overload, and noise levels. Based on real-time signal quality across channels, the system dynamically selects the optimal lead for analysis.

In the event of interference or lead disconnection, wSmartHeart® rapidly switches to the most reliable channel, minimizing false alarms and ensuring the accuracy of heart rate and arrhythmia detection.

• Clinical BenefitsAs illustrated in Figure below, when Lead I is heavily disturbed, single-lead analysis may result in inaccurate readings and excessive false alarms. wSmartHeart® intelligent lead optimization technology automatically detects high-noise signals and switches to alternative leads with reliable data.This significantly reduces false alarms and ensures continuous, accurate ECG monitoring—even under partial lead interference—enhancing clinical efficiency and patient safety.

Strong Anti-Interference Capability

wSmartHeart® ECG technology features robust anti-interference performance through advanced techniques such as PACE overshoot suppression, tall T wave recognition, and multi-template matching. These capabilities significantly reduce false alarms caused by misidentification and are essential for ensuring reliable and accurate ECG monitoring in clinical settings.

• Implementation Plan:

1) PACE Pulse SuppressionFor patients with pacemakers, large PACE overshoot signals can interfere with accurate heart rate calculation. wSmartHeart® ECG technology incorporates a hardware-based PACE pulse suppression filter to eliminate these high-amplitude artifacts.As illustrated in Figure below, the suppression filter effectively removes the PACE pulse, restoring the true QRS waveform and enabling accurate ECG recognition. Without this suppression, overshoot signals may be misidentified as QRS complexes, leading to false alarms and unreliable monitoring.

2）Enhanced T Wave Discrimination CapabilityElevated T waves are frequently observed in patients with arrhythmias and may compromise the accuracy of heart rate and arrhythmia detection. wSmartHeart® ECG technology incorporates advanced refractory period logic and T wave morphology analysis to differentiate and suppress abnormally prominent T waves.As illustrated in Figure below, even when the T wave amplitude exceeds that of the R wave, the system accurately identifies and excludes T wave artifacts from QRS detection. This ensures precise heart rate computation and improves the overall fidelity of ECG signal interpretation in clinical settings.

3）Advanced Multi-Scale Template MatchingwSmartHeart® ECG technology utilizes advanced multi-scale template matching that incorporates QRS morphology, QRS duration, and RR interval metrics. This multidimensional approach enhances the precision of arrhythmia classification beyond conventional single- parameter template matching.As illustrated in Figure below, this technique enables more robust QRS complex discrimination and significantly improves the reliability of arrhythmia detection under diverse clinical conditions.

• Clinical BenefitswSmartHeart® ECG technology demonstrates superior anti-interference performance in real- world clinical environments. Clinical data show that while conventional ECG systems generate false alarms in approximately 23% of cases due to misrecognition, wSmartHeart® reduces this rate to just 3%. This represents a more than 20% reduction in false alarms, significantly enhancing monitoring reliability and reducing clinical workload.