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