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International projects source: SICRIS

Simulator to test automated non-invasive sphygmomanometer on compliance with the overall system accuracy defined in en 1060-3

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Organisations (1)
no. Code Research organisation City Registration number No. of publications
1.  0101  Institute of Mathematics, Physics and Mechanics  Ljubljana  5055598000  20,221 
Abstract
At present, the accuracy of automated non-invasive sphygmomanometers is determined solely in a clinical test as described in the harmonised standard EN 1060. However, the results obtained are of limited value with respect to device performance evaluation. A simulator, which is able to replay well-characterised biosignals recorded from humans will considerably improve the judgement on the device quality and reduces the number of required clinical tests. The objective is to develop such a simulator. This includes the development of a recording system and the establishment of a reference data set of blood pressure signals that reflects the common variability of blood pressure measurements acquired in practice. The signals will be thoroughly evaluated clinically and technically before becoming part of the reference database. Finally requirements and test procedures for the standard shall be developed as part of the work program.
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