This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment:

— intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;

NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. High-frequency ventilators for this environment are considered life-sustaining.

NOTE 2 For the purposes of this document, such a high-frequency ventilator can provide transport within a professional healthcare facility (i.e., be a transit-operable ventilator).

NOTE 3 A high-frequency ventilator intended for use in transport within a professional healthcare facility is not considered as a ventilator intended for the emergency medical services environment. — intended to be operated by a healthcare professional operator;

— intended for those patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; and

— capable of providing more than 150 inflations/min.