This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, for VENTILATORY INSUFFICIENCY, as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT, in combination with its ACCESSORIES: — intended for use in the HOME HEALTHCARE ENVIRONMENT; — intended for use by a LAY OPERATOR; — intended for use with PATIENTS who have VENTILATORY INSUFFICIENCY or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation; — intended for TRANSIT-OPERABLE use; — not intended for PATIENTS who are dependent on artificial ventilation for their immediate life support.