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A Novel 12-Lead Electrocardiographic System for Home Use: Development and Usability Testing
Annemarijn Sm Steijlen1, Kaspar Mb Jansen1, Armagan Albayrak2
1Design Engineering, Faculty of Industrial Design Engineering, Delft University of Technology, Delft, Netherlands.
JMIR Mhealth and Uhealth
|August 1, 2018
Summary
A new 12-lead electrocardiogram (ECG) system was developed for home use, enabling reliable cardiac monitoring. This user-friendly device aims to improve early diagnosis of arrhythmias and ischemia, reducing complications like stroke.
Area of Science:
- Biomedical Engineering
- Cardiology
- Medical Devices
Background:
- Cardiovascular diseases (CVD) are a leading global cause of death.
- Early diagnosis of cardiac arrhythmias and ischemia is crucial to prevent severe outcomes like stroke and myocardial infarction.
- Existing home-based diagnostic systems fail to provide reliable 12-lead electrocardiogram (ECG) recordings.
Purpose of the Study:
- To develop an intuitive system for patients with cardiac complaints to perform reliable 12-lead ECG recordings at home.
- To enhance the diagnostic process by enabling timely symptom capture.
- To reduce the delay between symptom onset and appropriate medical treatment.
Main Methods:
- An iterative design approach was employed to develop the ECGraph system, comprising an ECG measurement device and a mobile application.
- Concept testing guided the development process.
- A prototype underwent technical performance and usability testing.
Main Results:
- The ECGraph system includes a wearable belt with 10 wet Ag/AgCl electrodes and 4 limb straps, controlled via a mobile app.
- Users can perform ECG recordings within minutes of experiencing symptoms, with visual guidance provided.
- Usability tests indicated participants could don the device within 8 minutes on first use, with potential for faster application with familiarity. Technical tests confirmed reproducible 12-lead ECG generation.
Conclusions:
- A novel 12-lead ECG system for home use has been developed.
- The system is designed for enhanced user-friendliness and data reliability compared to existing home-use devices, facilitating expert interpretation.
- The ECGraph system holds significant potential for integration into outpatient care to enable early diagnosis and treatment of arrhythmias and ischemia.
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