6.1. Indications for use
The PMcardio mobile application is intended for use by qualified healthcare professionals, for the assessment of Electrocardiograms in subjects over 18 years of age. PMcardio should be used in a professional healthcare environments and its use should not be limited to a specific patient population.
Indications for use include patients presenting with common cardiovascular symptoms, such as Chest pain, Palpitations, Shortness of breath, Syncope. Additionally, PMcardio should be used in all situations when an ECG exam is performed or gathered by the intended users including routine examinations, preoperative testing, sport exams and vitals testing in the urgent care setting.
6.2. Contra-indications and exclusions
The use of PMcardio is not recommended for the management of pediatric patients or patients under the age of 18, due to different normal ranges for electrocardiographic measurements. The use of PMcardio is not recommended for the analysis of stress test ECG recordings and Holter recordings. Furthermore, it is not recommended to use PMcardio for the assessment of other waveform data such as electroencephalograms (EEGs) depicting electrical activity of the brain, due to different features of the waveform. The PMcardio mobile application is not for use in life-supporting or sustaining systems or ECG monitor and Alarm devices. PMcardio mobile application interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis in conjunction with the physicianʼs knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
6.3. Intended users
The PMcardio mobile application is intended to be used by the following users:
- Non-Cardiologist Physicians, e.g., General Practitioners (GP)
- Cardiologists (General Cardiologist, Specialized Cardiologist)
- Emergency Medical Service (EMS) Workers
- Medical students during clinical rotations
Based on a demographic and use-case analysis, the users are grouped to the following user groups:
- Non-Physician Health Care Professionals
6.4. Characterization of Patients
PMcardio is intended to be used as a standard tool to analyze and interpret standard 12-lead electrocardiograms recorded by healthcare professionals and physicians for patients over 18 years of age. Following types of adult patients can be considered:
- Healthy patients presenting to the GP for routine examination
- Asymptomatic patients
- Symptomatic patients presenting to the GP, emergency department, ambulance
- Patients with known chronic cardiovascular disease followed-up by GPs or internal medicine physicians
Furthermore, PMcardio may be used for patients of any gender, patient comorbidities or risk factors, physical properties, or social and cultural background.