The Hayek RTX Respirator is a prescription-only medical device designed to deliver Biphasic Cuirass Ventilation (BCV), a form of non-invasive external ventilation delivered using a cuirass shell applied to the chest wall. The device may be configured by clinicians to provide external ventilation resulting in gas exchange and to assist with secretion clearance management in adult and pediatric patients.
Secretion clearance support may include clinician-directed use of externally applied chest wall vibration intended to assist with mobilization of secretions, as well as cough phase designed to support expectoration as part of an overall secretion clearance approach.
BCV may be incorporated into clinician-directed treatment approaches for non-invasive external ventilation and secretion clearance management in appropriate patients. The Hayek RTX Respirator may be configured by clinicians to support ventilation and airway clearance strategies based on individual patient needs and care setting.
Device configuration, prescribed settings, duration of use, and clinical application are determined by the treating healthcare professional as part of the overall plan of care.
BCV may be considered by clinicians in adult and pediatric patients in a variety of clinical scenarios where ventilation or secretion clearance management is appropriate.
Evaluation of ventilation approaches may occur across different care settings and clinical contexts as part of an overall respiratory support strategy.
Patient selection, device configuration, and treatment parameters are determined by the prescribing clinician based on individual patient needs and clinical judgment.
Use of the device is determined by the prescribing clinician based on individual clinical assessment and cleared device indications.
