Design and development of a validation framework for ECG device stabilisation

Vehicle ECG instruments rank amongst the most critical of medical devices. However, ensuring their safe use is a challenge, as a number of regulations need to be complied before they are certified to be safe for both patients and medical personnel. Using a validation Framework, all stakeholders involved in ECG instruments can test their instruments and validate them. Currently there is no one-stop validation Framework that is inexpensive and easy to use.

This paper documents the development of a validation Framework for validating ECG instruments. This can be interfaced with ECG databases and ECG devices to conduct the validation testing. The device under test will be interfaced with validation Framework with communication protocols and the frame work will be interacting with the device for testing the validation vectors. The critical test vectors of validation Framework will validate the ECG device for rejection of noise analysis, pacemaker pulse analysis capabilities, T wave rejection analysis, detection of arrhythmias, heartbeat accuracy and response analysis for triangular waveforms. The validation Framework consists of several virtual instruments, constructed in LabVIEW, to generate and compare waveforms corresponding to the aforementioned critical areas.

The system is simple and easy to use with clear visual displays that allows for immediate comparison of waveforms, diagnosis and analysis. All of the test vectors are tested for performance and consistency with design specifications. It was found that the validation Framework was successfully able to validate each of the cases tested. An efficiency comparison with conventional test methods was carried out and it was found that validation Framework reduces the test cycle time significantly.