This master thesis presents the development of a 12-lead electrocardiographic system for home use. The project focusses on the product design aspects of this system. By doing thorough context and user research it is aimed to an accessible product service system for the patient as
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This master thesis presents the development of a 12-lead electrocardiographic system for home use. The project focusses on the product design aspects of this system. By doing thorough context and user research it is aimed to an accessible product service system for the patient as well as the healthcare professional. Two cardiologists from the Academic Medical Centre in Amsterdam noticed that for diagnosing arrhythmias and infarctions at an early stage, it is needed to enable patients themselves to make 12-lead ECGs anywhere and anytime symptoms occur. Patients with arrhythmias often have symptoms for a short period of time. Fast diagnosis is hindered, because symptoms often do not occur at the time that ECGs are made in the hospital. Besides, patients who are about to have an infarction are in many cases warned by episodes of chest pain. This pain is often ignored for some time, whereas the patient has to act quickly to minimize damage. Based on an analysis of these problems, a design vision for this project was formed. In this design vision is stated that the new product service system should enable patients to make a reliable 12-lead ECGs at home. The patient should be involved in the diagnostic process by creating an easy-to-use product-service system to empower them to record essential data for diagnosing arrhythmias and ischemia. The design vision formed the start of the conceptualization phase. Several concepts were created and the main aspects of the final design were determined. It was chosen to create an ECG belt with four limb straps and integrated electrodes. The product contains ten wet electrodes that are placed at the standard locations according to the general procedure of making a rest ECG in the hospital. The product can be worn by people with different shapes and sizes, since the belt stretches and the electrodes automatically move to the right locations relative to each other. In this way, right placement of the electrodes is facilitated. The product is controlled by the smartphone of the user. Via an application, the user can record the ECGs and send them, together with a description of the complaints, to the hospital. The cardiologist will interpret the results and will send a message with an advice to the patient. The product was designed in detail in the embodiment phase of the project. Besides, a service blueprint was made. Since cardiologists will be more aware of the advantages of this product, it will be their task to create awareness among the potential users. The product will be handed to the user via hospitals. In this way, it can be controlled who is going to use the device and send ECGs to the cardiologist. To evaluate the feasibility and ease-of-use, a final prototype of the belt was made. An existing ECG system was connected to the belt and it was found that the electrodes made good contact to the skin and the ECGs were very similar to the ECGs that were made with a standard ECG system from the hospital. Besides, it was found that, although participants of the user test felt not very confident about using the product for the first time, all participants could put on the product in the right way with the help of some supporting visualizations. It has been concluded that a feasible proposal was made. The product is more user-friendly than the current hospital ECG systems and on the other hand the new system records more reliable and suitable data than current ECG solutions for home use. The system has great potential to be incorporated in clinical practice, so that arrhythmias and ischemia can be diagnosed faster.