scope:

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPM ENT, as defined in 201.3.205, for VE NTILATORY INSUFFICIENCY, as defined in 201.3.203, hereafter also referred to as ME EQUIPM ENT, in combination with its ACCESSORIES: - intended for use in the HOME HEALTHCARE ENVIRONME NT; - intended for use by a LAY OPERATOR; and - intended for use with PATIENTS who have VENTILATORY INSUFFICIENCY or failure, but who are not dependent on mechanical ventilation for their life support. EXAMPLE 1 PAT IE NTS with mode rate to severe chronic obstructive pulmonary disease (COPD) or moderate Amyotrophic Lateral Sclerosis (ALS). NOTE 1 - In the HOM E H E AL T HCA RE E NVIRONM E NT , the SU PPL Y M Ains is often not reliable. NOTE 2 - Such VE NT ILAT ORY SU PPO RT E QUIPM E NT can also be used in non-critical care applications of professional health care facilities. This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to the VE NTILATOR BRE ATHING SY STEM of VENTILATORY SUPPORT E QUIPMENT for VENTILATORY INSUFFICIENCY , where the characteristics of those ACCESSORIE S can affect the BASIC SAFETY or E SSENTIAL PERFORMANCE of the VENTILATORY SUPPORT EQUIPMENT VENTILATORY INSUFFICIENCY.