WP1: Advanced oscillometric signal generator for real-life signals
The aim of this WP1 is to develop and evaluate an advanced oscillometric signal generator (aOSG) able to accurately reproduce pre-recorded real-life oscillometric signals. The intention is that this aOSG will substitute human subjects when testing the accuracy of automated sphygmomanometers by replaying pre-recorded human oscillometric signals stored in a data base. Since a considerable database containing a large variety of human oscillometric signals is needed, a pre-existing database will be used for tests using the aOSG.
To test the performance of the aOSG, a recording unit (RU) is necessary and will be developed to record the signals generated by the aOSG and compare these with the database (input) signals.
Activities of WP1 will focus on:
Defining specifications for the hardware and software of the aOSG and proposing a forward model for the technical measurement uncertainty of systolic, diastolic and mean blood pressure.
Performing a thorough market research, identification of appropriate commercial devices & investigation of their performance.
Design, production and testing of a recording unit able to record oscillometric signals .
Development & performance testign of an oscillometric signal generator (including hardware and software.
WP2: Development of procedures for testing sphygmomanometers with an aOSG
The aim of WP2 is to elaborate procedures for the dynamic testing of automated oscillometric sphygmomanometers using the advanced oscillometric signal generator (aOSG) developed in WP1. These procedures will allow the aOSG to be used as an absolute reference device for the metrological verification and reverification of sphygmomanometers.
The test procedures for the aOSG are the crucial step in assessing the suitability and performance of the aOSG and hence shall at least satisfy the requirements of the ISO standard ISO 81060-2. That requires detail knowledge of the standard ISO 81060-2, extensive database of accurate and validated real-life oscillometric signals, development and testing of the procedure itself and finally drafting a guide for testing sphygmomanometers using an aOSG.
Activities of WP2 will focus on:
Proposing a procedure for collecting and processing real-life oscillometric data. Although it is not intended within this project to collect additional oscillometric data, the expertise in the consortium should be used to propose an adequate procedure for future purposes. This procedure will be made available on the project’s website.
Defining a set of procedures for the testing of automated sphygmomanometers using the aOSG developed.
Practical validation of the procedure proposed above. If required, the procedure will be adjusted and optimised.
WP3: Procedure for calibration and recalibration of the aOSG
The aim of WP3 is to define procedures and select appropriate methods for calibration of the oscillometric signal generator.
In order to serve as an absolute standard for oscillometric blood pressure signals, dynamic traceability of the aOSG must be ensured. This has to be done at static and at dynamic pressures and a maximum uncertainty of ± 1.5 mmHg must be achieved. New means and methods have to be selected and evaluated, model for uncertainty budget has to be formulated and guidelines how to perform such calibrations have to be written.
Therefore, this work-package will focus on specific aspects of establishing the dynamic pressure traceability of the aOSG:
Activities of WP3 will focus on:
A survey on possible solutions of dynamic pressure traceability will be undertaken, technical and metrological requirements for the test equipment will be stated and appropriate calibration equipment will be selected.
The routes to traceability of the aOSG will be established. That will require extensive research on all aspects of the aOSG calibration, e.g. selection of appropriate test signals, formulation of model for uncertainty, drafting the procedure for calibration, etc.
Results of above will be evaluated. Sample calibration of the aOSG will be performed to prove the suitability of the selected tools and methods, final version of the calibration guide will be created and the outcome of this task will be published as a paper on dynamic pressure calibration.
WP4: Smart specialisation concept
The aim of WP5 is to develop and implement a smart specialisation concept for traceable oscillometric blood pressure measurements and research in Europe.
This concept will be suitable as a foundation for a long-term partnership, i.e. beyond the end of this project, in advanced blood pressure metrology in Europe. The specialisation will be coordinated to optimally utilise the limited national capacities in a smart division of labour and resources. Stakeholder involvement will be crucial to achieve the goal of this work package. The implementation of the smart specialisation concept will be essential to ensure that the main aim of the whole project will persist beyond the end of the project. The perpetuation of this concept is another important objective of this work package.
Since there are other, already running, projects utilising and developing the smart specialisation concept for medical measuring instruments, e.g. 16RPT03 inTENSE, the consortium will actively investigate for possible cooperation, knowledge, infrastructure sharing and synergy with such projects. The long-term goal of such collaboration and synergy would be creation of European centre for medical device metrology.
Besides implementing the smart specialisation concept, this work package aims to take all the necessary steps to allow the use of the aOSG as intended, i.e. as market surveillance tool and tool for in-depth sphygmomanometer performance checks during pre-market and subsequent examination. This will require detailed assessment of important findings from WP1, WP2 and WP3. The aim of this WP will be achieved through the combination of the technical findings of all previous WPs, knowledge of needs of the stakeholders and eventual legal requirements.
Activities of WP4 will focus on:
Establishing a network of organisations interested in advanced blood pressure measurements and a competence centre.
Checking conformity of the project aims with legal requirements in each partner’s country.
Setting up a laboratory which will be able to provide dynamic traceability to the aOSG.
Further expanding he smart specialisation concept & cretation of a White Paper on smart specialisation concept.
Preparation of individual strategies for the use of the joint research capacity (i.e competence centre) by the internal partners.
WP5: Creating impact
The aim of WP5 is to disseminate project results to stakeholders, scientific, medical and metrological communities,surveillance bodies, manufacturers of sphygmomanometers…
WP6: Management and coordination
The project will be managed by the coordinator from CMI, who will be supported by the project management board consisting of one representative from each partner.
The members of the project management board will guide the project, attend the project meetings, organise the progress meetings and call additional meetings if needed to ensure the overall project’s success..