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<p>This document specifies requirements for the repeatability and reproducibility of <i>non-invasive</i> <i>blood pressure</i> (<i>NIBP</i>) simulators intended to test <i>automated sphygmomanometers</i> utilizing the oscillometric non-continuous method only. </p>
<p>In addition, the pulse rate set on the <i>NIBP simulator</i> is tested.</p>
<p>This document is not intended to relate the signals, generated by the <i>NIBP simulator</i>, to the oscillometric signal recorded in a <i>cuff</i> attached to a human. It does not intend to test the interaction between the <i>NIBP simulator</i> and the tested <i>automated sphygmomanometer</i> (e.g. the agreement of the set values of the <i>NIBP simulator</i> and the displayed values of the tested <i>automated sphygmomanometer</i> or the properties of the <i>cuff</i> and tubing, such as design or elastic properties). </p>
<p>NOTE 1 These parameters can be tested separately in a <i>clinical investigation</i> or by using different special test setups. </p>
<p>This document does not check whether or not the <i>NIBP simulator</i> is able to test the accuracy of the absolute <i>blood pressure</i> value of oscillometric <i>automated sphygmomanometers</i>.</p>
<p>NOTE 2 Usually this is tested by a <i>clinical investigation</i> according ISO 81060-2 or other protocols.</p>
<p>This document is applicable to <i>NIBP simulators</i> testing <i>automated sphygmomanometers</i> for adults, children and neonates at the upper arm, thigh etc. and <i>automated sphygmomanometers</i> measuring at the wrist.</p>
Reģistrācijas numurs (WIID)
74256
Darbības sfēra
<p>This document specifies requirements for the repeatability and reproducibility of <i>non-invasive</i> <i>blood pressure</i> (<i>NIBP</i>) simulators intended to test <i>automated sphygmomanometers</i> utilizing the oscillometric non-continuous method only. </p>
<p>In addition, the pulse rate set on the <i>NIBP simulator</i> is tested.</p>
<p>This document is not intended to relate the signals, generated by the <i>NIBP simulator</i>, to the oscillometric signal recorded in a <i>cuff</i> attached to a human. It does not intend to test the interaction between the <i>NIBP simulator</i> and the tested <i>automated sphygmomanometer</i> (e.g. the agreement of the set values of the <i>NIBP simulator</i> and the displayed values of the tested <i>automated sphygmomanometer</i> or the properties of the <i>cuff</i> and tubing, such as design or elastic properties). </p>
<p>NOTE 1 These parameters can be tested separately in a <i>clinical investigation</i> or by using different special test setups. </p>
<p>This document does not check whether or not the <i>NIBP simulator</i> is able to test the accuracy of the absolute <i>blood pressure</i> value of oscillometric <i>automated sphygmomanometers</i>.</p>
<p>NOTE 2 Usually this is tested by a <i>clinical investigation</i> according ISO 81060-2 or other protocols.</p>
<p>This document is applicable to <i>NIBP simulators</i> testing <i>automated sphygmomanometers</i> for adults, children and neonates at the upper arm, thigh etc. and <i>automated sphygmomanometers</i> measuring at the wrist.</p>
