A method for evaluating the performance and quality of a non-invasive cardiopulmonary function monitoring device

By constructing multi-dimensional standardized evaluation items and real-time data acquisition, the problems of cross-module performance shortcomings and static test deviations in the evaluation of non-invasive cardiopulmonary function monitoring devices have been solved. This has enabled a comprehensive and objective evaluation of device performance and a stability evaluation under dynamic operating conditions, thereby improving the clinical reference value and consistency of the evaluation results.

CN122306454APending Publication Date: 2026-06-30SICHUAN UNIV
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
SICHUAN UNIV
Filing Date
2026-04-23
Publication Date
2026-06-30

AI Technical Summary

Technical Problem

Existing evaluation methods for non-invasive cardiopulmonary function monitoring devices lack multi-dimensional and systematic integration, failing to fully reflect the clinical suitability of the devices. Furthermore, reliance on static laboratory tests leads to discrepancies between evaluation results and actual clinical manifestations. Evaluation results are also susceptible to human factors and lack unified quantitative evaluation standards.

Method used

A standardized evaluation system covering ventilation, circulation, gas analysis, sensor performance, and electrical safety is established. Through real-time data acquisition from calibration tests, clinical tests, and interference tests, combined with actual clinical operating data on gas path openness, tubing reuse, and automatic drying, a unified quantitative evaluation standard and automated judgment process are adopted to generate an evaluation report that includes quality control analysis and Chinese diagnostics.

Benefits of technology

It enables a comprehensive, objective, and repeatable evaluation of device performance, ensuring that the evaluation results truly reflect the stability and reliability of the device under dynamic operating conditions, improving the clinical reference value and consistency of the evaluation results, and providing a standardized basis for quality control.

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Abstract

This invention discloses a performance quality evaluation method for a non-invasive cardiopulmonary function monitoring device, belonging to the field of medical device performance testing technology. The key technical points include: acquiring environmental adaptation data and clinical testing data of the non-invasive cardiopulmonary function monitoring device; constructing standardized evaluation items for the device based on the environmental adaptation data and clinical testing data; configuring evaluation thresholds and evaluation weights corresponding to the standardized evaluation items; collecting real-time output data of the device under test under calibration testing, clinical testing, and interference testing; calculating individual evaluation coefficients based on the real-time output data, evaluation thresholds, and evaluation weights; and comparing the individual evaluation coefficients with preset qualified thresholds. The effect is that through systematic integrated evaluation of key indicators, it can accurately capture the clinical data distortion problem caused by cross-module deviations despite standardized evaluation items meeting the standards, comprehensively reflecting the clinical suitability of the device and avoiding the clinical risks brought about by one-sided evaluations.
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