TeleRehab Aermos Cardiopulmonary Rehabilitation

The TeleRehab Aermos Cardiopulmonary Rehabilitation System acquires and wirelessly transmits single-channel ECG signals from patients to a clinical workstation for display and analysis. It measures heart rate, provides visual and audible alarms when heart rate deviates from prescribed ranges, and stores physiological data and patient information in a database to track rehabilitation progress in ambulatory adult patients undergoing cardiovascular or pulmonary rehabilitation in hospital or clinic settings.

The Aermos system uses WiFi 802.11 b/g/n at 2.4 GHz for radiofrequency transmission (versus predicate's Bluetooth), captures one ECG channel with 3 lead wires (versus predicate's 2), features pacemaker pulse detection (predicate lacks this), and operates on a Windows-based PC workstation. Frequency response is 0.05–100 Hz with ±5.0 mV dynamic range. The device includes defibrillation protection and heart rate alarm functionality.

IEC 60601-1:2020, IEC 60601-1-2:2020, IEC 60601-1-6:2020, IEC 60601-1-8:2020, IEC 60601-2-27:2011, ANSI/AAMI EC57:2012, ANSI C63.27-2017, AAMI TIR69:2017, IEC 62304:2015, ISO 14971:2019, ANSI/AAMI EC53:2013, and FDA guidance documents on radio frequency wireless technology and cybersecurity in medical devices.

Both Aermos and the predicate (ers2) are Class II devices with identical indications for use, intended populations (adult), and intended environments (healthcare facilities). Both acquire single-channel ECG, transmit via radiofrequency to Windows-based workstations, and display heart rate with alarms. Although Aermos uses WiFi instead of Bluetooth and includes pacemaker detection not present in the predicate, safety and performance are demonstrated through compliance with IEC 60601-2-27 and other applicable standards; these differences do not raise new safety or effectiveness concerns for the intended use of rehabilitation monitoring.