mobiCARE™ ECG Monitoring System

The purpose of the Seers Technology Company Ltd. sponsored study using the mobiCARE™ ECG Monitoring System is to document the variability and interpretability of heart rhythm tracings from the nominal position whereby the mobiCARE™ device is still able to obtain interpretable ECG signals, in a cohort of adults representative of the U.S. population.

Informational data will be collected, such as P-wave amplitude and QRS amplitude and duration to note any morphological ECG signal changes. Human factors (HF) endpoints will be evaluated including: HCP placement according to IFU, subject demonstration of changing electrodes, dexterity for user to perform the task, electrode placement according to skin markings, and the ability of the user to remove and replace the mobiCARE™ device.

Inclusion criteria

• Male and female adults ≥ 18 years of age;
• Willing and able to provide informed consent;
• Able to speak and read English fluently;
• Participant is ambulatory.

Exclusion criteria

• Patients with cardiac pacemaker;
• Patients with cardioverter defibrillator;
• Patients with other implantable electric devices;
• Currently or has a medical history of skin cancer, rash, skin disorder, keloid, and/or any injury in the chest area;
• Patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient;
• Patients with known history of life-threatening arrhythmias;
• Use in combination with external cardiac defibrillators or high frequency surgical equipment near strong magnetic fields or devices such as MRI;
• Patients with neuro-stimulator, as it may disrupt the quality of ECG data;
• Critical care patients;
• Chest pain at the time of presentation for the study.