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<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho';">This document applies to the <em style="mso-bidi-font-style: normal;">basic safety</em> and <em style="mso-bidi-font-style: normal;">essential performance</em> of a <em style="mso-bidi-font-style: normal;">ventilator</em> in combination with its <em style="mso-bidi-font-style: normal;">accessories</em>, hereafter referred to as <em style="mso-bidi-font-style: normal;">ME equipment:</em></span></p>
<p class="ListContinue1" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho';">—<span style="mso-tab-count: 1;"> </span>intended for use in the <em style="mso-bidi-font-style: normal;">home healthcare environment;</em></span></p>
<p class="ListContinue1" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho';">—<span style="mso-tab-count: 1;"> </span>intended for use by a <em style="mso-bidi-font-style: normal;">lay operator;</em><span style="mso-bidi-font-style: italic;"> and</span></span></p>
<p class="ListContinue1" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho';">—<span style="mso-tab-count: 1;"> </span>intended for </span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">those <em style="mso-bidi-font-style: normal;">patients</em> who need differing levels of support from <em>artificial ventilation </em>including for <em style="mso-bidi-font-style: normal;">ventilator-dependent patients</em></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho';">.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho';">This document is also applicable to those <em style="mso-bidi-font-style: normal;">accessories</em> intended by their <em style="mso-bidi-font-style: normal;">manufacturer</em> to be connected to a <em style="mso-bidi-font-style: normal;">ventilator breathing system</em> or to a <em style="mso-bidi-font-style: normal;">ventilator</em> where the characteristics of those <em style="mso-bidi-font-style: normal;">accessories</em> can affect the <em style="mso-bidi-font-style: normal;">basic safety</em> or <em style="mso-bidi-font-style: normal;">essential performance</em> of the <em style="mso-bidi-font-style: normal;">ventilator</em>.</span></p>
Reģistrācijas numurs (WIID)
83464
Darbības sfēra
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho';">This document applies to the <em style="mso-bidi-font-style: normal;">basic safety</em> and <em style="mso-bidi-font-style: normal;">essential performance</em> of a <em style="mso-bidi-font-style: normal;">ventilator</em> in combination with its <em style="mso-bidi-font-style: normal;">accessories</em>, hereafter referred to as <em style="mso-bidi-font-style: normal;">ME equipment:</em></span></p>
<p class="ListContinue1" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho';">—<span style="mso-tab-count: 1;"> </span>intended for use in the <em style="mso-bidi-font-style: normal;">home healthcare environment;</em></span></p>
<p class="ListContinue1" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho';">—<span style="mso-tab-count: 1;"> </span>intended for use by a <em style="mso-bidi-font-style: normal;">lay operator;</em><span style="mso-bidi-font-style: italic;"> and</span></span></p>
<p class="ListContinue1" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho';">—<span style="mso-tab-count: 1;"> </span>intended for </span><span lang="EN-GB" style="mso-fareast-font-family: 'Arial Unicode MS';">those <em style="mso-bidi-font-style: normal;">patients</em> who need differing levels of support from <em>artificial ventilation </em>including for <em style="mso-bidi-font-style: normal;">ventilator-dependent patients</em></span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho';">.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 'MS Mincho';">This document is also applicable to those <em style="mso-bidi-font-style: normal;">accessories</em> intended by their <em style="mso-bidi-font-style: normal;">manufacturer</em> to be connected to a <em style="mso-bidi-font-style: normal;">ventilator breathing system</em> or to a <em style="mso-bidi-font-style: normal;">ventilator</em> where the characteristics of those <em style="mso-bidi-font-style: normal;">accessories</em> can affect the <em style="mso-bidi-font-style: normal;">basic safety</em> or <em style="mso-bidi-font-style: normal;">essential performance</em> of the <em style="mso-bidi-font-style: normal;">ventilator</em>.</span></p>
