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<p>This document is applicable to the <i>basic safety</i> and <i>essential performance</i> of oxygen <i>conserving equipment</i>, hereafter referred to as <i>ME equipment,</i> in combination with its <i>accessories </i>intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the <i>patient's </i>inspiratory cycle, when used in the <i>home healthcare environment</i>. Oxygen <i>conserving equipment</i> is typically used by a <i>lay operator</i>. </p>
<p>NOTE 1 <i>Conserving equipment</i> can also be used in professional health care facilities<i>.</i></p>
<p>This document is also applicable to <i>conserving equipment</i> that is incorporated with other equipment. </p>
<p>EXAMPLE <i>Conserving equipment</i> 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 <i>accessories</i> intended by their <i>manufacturer</i> to be connected to <i>conserving equipment</i>, where the characteristics of those <i>accessories</i> can affect the <i>basic safety</i> or <i>essential performance</i> of the <i>conserving equipment</i>. </p>
<p>This document is intended to clarify the difference in operation of various <i>conserving equipment</i> models, as well as between the operation of <i>conserving equipment </i>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 <i>ME equipment</i> only, or to <i>ME systems</i> 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 <i>ME equipment</i> and to <i>ME systems</i>, as relevant.</p>
<p><i>Hazards</i> inherent in the intended physiological function of <i>ME equipment</i> or <i>ME systems</i> 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)
75945
Darbības sfēra
<p>This document is applicable to the <i>basic safety</i> and <i>essential performance</i> of oxygen <i>conserving equipment</i>, hereafter referred to as <i>ME equipment,</i> in combination with its <i>accessories </i>intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the <i>patient's </i>inspiratory cycle, when used in the <i>home healthcare environment</i>. Oxygen <i>conserving equipment</i> is typically used by a <i>lay operator</i>. </p>
<p>NOTE 1 <i>Conserving equipment</i> can also be used in professional health care facilities<i>.</i></p>
<p>This document is also applicable to <i>conserving equipment</i> that is incorporated with other equipment. </p>
<p>EXAMPLE <i>Conserving equipment</i> 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 <i>accessories</i> intended by their <i>manufacturer</i> to be connected to <i>conserving equipment</i>, where the characteristics of those <i>accessories</i> can affect the <i>basic safety</i> or <i>essential performance</i> of the <i>conserving equipment</i>. </p>
<p>This document is intended to clarify the difference in operation of various <i>conserving equipment</i> models, as well as between the operation of <i>conserving equipment </i>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 <i>ME equipment</i> only, or to <i>ME systems</i> 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 <i>ME equipment</i> and to <i>ME systems</i>, as relevant.</p>
<p><i>Hazards</i> inherent in the intended physiological function of <i>ME equipment</i> or <i>ME systems</i> 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>
