Full Description

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 whoseconditions can be life-threatening and who can require comprehensive care and constantmonitoring 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 ventilationincluding ventilator-dependent patients; and

capable of providing more than 150 inflations/min.

Product Details

Published: 03/31/2021 File Size: 1 file , 2.6 MB Same As: BS EN ISO 80601-2-87:2021, DIN EN ISO 80601-2-87 Note: This product is unavailable in Ukraine, Russia, Belarus