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<p>This document is applicable to the <em>basic safety</em> and <em>essential performance</em> of oxygen <em>conserving equipment</em>, hereafter referred to as <em>ME equipment,</em> in combination with its <em>accessories </em>intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the <em>patient's </em>inspiratory cycle, when used in the <em>home healthcare environment</em>. Oxygen <em>conserving equipment</em> is typically used by a <em>lay operator</em>.</p>
<p>NOTE 1 <em>Conserving equipment</em> can also be used in professional health care facilities<em>.</em></p>
<p>This document is also applicable to <em>conserving equipment</em> that is incorporated with other equipment.</p>
<p>EXAMPLE <em>Conserving equipment</em> combined with a pressure regulator<sup>[2]</sup>, an oxygen concentrator<sup>[7]</sup> or liquid oxygen equipment<sup>[4]</sup>.</p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to <em>conserving equipment</em>, where the characteristics of those <em>accessories</em> can affect the <em>basic safety</em> or <em>essential performance</em> of the <em>conserving equipment</em>.</p>
<p>This document is intended to clarify the difference in operation of various <em>conserving equipment</em> models, as well as between the operation of <em>conserving equipment </em>and continuous flow oxygen equipment, by requiring standardized performance testing and labelling.</p>
<p>This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).</p>
<p>If a clause or subclause is specifically intended to be applicable to <em>ME equipment</em> only, or to <em>ME systems</em> only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to <em>ME equipment</em> and to <em>ME systems</em>, as relevant.</p>
<p><em>Hazards</em> inherent in the intended physiological function of <em>ME equipment</em> or <em>ME systems</em> within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1.</p>
<p>NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.</p>
Reģistrācijas numurs (WIID)
87163
Darbības sfēra
<p>This document is applicable to the <em>basic safety</em> and <em>essential performance</em> of oxygen <em>conserving equipment</em>, hereafter referred to as <em>ME equipment,</em> in combination with its <em>accessories </em>intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the <em>patient's </em>inspiratory cycle, when used in the <em>home healthcare environment</em>. Oxygen <em>conserving equipment</em> is typically used by a <em>lay operator</em>.</p>
<p>NOTE 1 <em>Conserving equipment</em> can also be used in professional health care facilities<em>.</em></p>
<p>This document is also applicable to <em>conserving equipment</em> that is incorporated with other equipment.</p>
<p>EXAMPLE <em>Conserving equipment</em> combined with a pressure regulator<sup>[2]</sup>, an oxygen concentrator<sup>[7]</sup> or liquid oxygen equipment<sup>[4]</sup>.</p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to <em>conserving equipment</em>, where the characteristics of those <em>accessories</em> can affect the <em>basic safety</em> or <em>essential performance</em> of the <em>conserving equipment</em>.</p>
<p>This document is intended to clarify the difference in operation of various <em>conserving equipment</em> models, as well as between the operation of <em>conserving equipment </em>and continuous flow oxygen equipment, by requiring standardized performance testing and labelling.</p>
<p>This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).</p>
<p>If a clause or subclause is specifically intended to be applicable to <em>ME equipment</em> only, or to <em>ME systems</em> only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to <em>ME equipment</em> and to <em>ME systems</em>, as relevant.</p>
<p><em>Hazards</em> inherent in the intended physiological function of <em>ME equipment</em> or <em>ME systems</em> within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1.</p>
<p>NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.</p>
