Clause 1 of the general standard (IEC 60601-1:2005+AMD1:2012,) applies, except as follows:
Replacement:
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.
There are three principal designations of HFV:
⎯ high frequency percussive ventilation (HFPV, with a typical HFV frequency of (60 to 1 000) HFV inflations/min);
⎯ high frequency jet ventilation (HFJV, with a typical HFV frequency of (100 to 1 500) HFV inflations/min); and
⎯ high frequency oscillatory ventilation (HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase).
Additionally, HFV designations can be combined together or with ventilation at rates less than 150 inflations/min.
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