Pivotal Study of the Performance and Safety of the Pneumoscope Device in Adults and Children
Respiratory diseases are associated with high morbidity and mortality worldwide. Proper diagnosis and risk assessment of these conditions are essential for optimal management. Clinicians use three particularly useful tools to identify these conditions when assessing the patient's status: the stethoscope, the pulse oximeter, and the thermometer. The Pneumoscope is an all-in-one device including a digital stethoscope, a pulse oximeter, and a thermometer. This study aims to assess the performance and safety of the Pneumoscope in recording respiratory sounds, body temperature, non-invasive blood oxygen saturation levels and heart rate in children and adults.
• Age \> 1 year old.
• Healthy patients on the day of auscultation OR
• Patients with lower respiratory tract diseases (e.g., bronchitis, pneumonia, etc.). OR
• Patients with low (i.e., \<92%) pulse oximetry values (e.g., cyanotic heart defect such as tetralogy of Fallot, transposition of great vessels, etc.). AND / OR
• Patients with fever \>38.0°C.
• And for all: Information and written consent of the patient or a legal representative.