Single limb electrocardiogram using vector mapping: Evaluation and validation of a novel medical device

Area of Science:

• Biomedical Engineering
• Cardiology
• Medical Devices

Background:

• Electrocardiogram (ECG) monitoring is crucial for assessing cardiac function.
• Traditional multi-lead ECGs can be cumbersome for continuous monitoring.
• Novel single-limb devices offer potential for more convenient ECG acquisition.

Purpose of the Study:

• To evaluate the diagnostic accuracy of the Tiger Tech Warfighter Monitor (WFM), a single-limb ECG device.
• To compare the WFM's heart rate, R-R interval, and heart rate variability monitoring against a standard 2-lead chest ECG.

Main Methods:

• Simultaneous ECG monitoring using the WFM and a 2-lead chest ECG was performed on 26 subjects.
• Data was collected in a pre-operative holding unit under IRB approval.
• Proprietary algorithms were used for data extraction, synchronization, and beat-to-beat variation analysis.

Main Results:

• Excellent linear correlation was observed between the WFM and chest ECG for heart rate (R² = 0.99) and R-R interval (R² = 0.95).
• Heart rate variability metrics, including SDNN, RMSSD, and LnRMSSD, also showed excellent correlation (R² > 0.99).
• Statistically significant correlations were achieved in all 26 participants.

Conclusions:

• The WFM demonstrates high diagnostic accuracy for heart rate, R-R interval, and heart rate variability monitoring.
• The single-limb WFM is a viable alternative to traditional chest ECG for these cardiac parameters.