scope:

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 an 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.