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 MEÂ 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; NOTEÂ 1Â Â Â For the purposes of this document, such an environment is referred to as a critical...view more

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    • Standard
      136 pages
      English language
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    • Standard
      144 pages
      French language
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    • Draft
      136 pages
      English language
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    • Draft
      144 pages
      French language

This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment: intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; intended to be operated by a healthcare professional operator; intended for use in the EMS environment; and intended for invasive or non-invasive ventilation. NOTE 1 An EMS ventilator can also be used f...view more

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    • Standard
      110 pages
      English language
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    • Standard
      110 pages
      English language
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    • Standard
      122 pages
      French language
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    • Standard
      122 pages
      French language

This document applies to the basic safety and essential performance of a ventilator 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. Ventilato...view more

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    • Standard
      138 pages
      English language
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    • Standard
      142 pages
      French language