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Content archived on 2024-06-11

Pulse Oximeter Calibrator

Objective



The objective of the proposal is to contribute to a uniform quality of patient diagnosis during anaesthesia and in intensive care within the EC countries. The development of a convenient method and of the corresponding hardware for an objective comparison of commercially available pulse oximeters is a step in this direction. Conditions under which pulse oximeters are to be tested should not only refer to "normal" patient values but also include pathological values because it is especially in these circumstances where the physician needs most the support of monitors such as pulse oximeters. Currently available pulse oximeters use different unpublished and often untested algorithms. This makes it difficult for the physician to validate his clinical findings in a reproducible manner. During the elaboration of the European standard for pulse oximeters (pr EN 865) this has been identified as a serious problem. The fulfilment of the essential requirements in the Medical Device Directive 93/42/EEC is not feasible without a calibration unit. This is the reason for CEN TC 215 to propose this problem for investigation in order to make a standardisation procedure possible. The project will be carried out in close collaboration with and under guidance of CEN TC 215. It will consist of two major steps: The first step includes the analysis of the optical properties of the tissue areas where pulse oximeters are applied and of the dynamic behaviour of pulse waves. Data from studies on a large population of patients will be stored in a data pool. In step 2, based on the data of step 1, a microcomputer controlled Calibrator will be developed by which different optical conditions of blood and tissue and of different pulse waveforms can be simulated. The Calibrator is to be tested in the laboratory and in comparison with patient data obtained by standard analysis of patient blood.

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Programme(s)

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Topic(s)

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Funding Scheme

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CSC - Cost-sharing contracts

Coordinator

Medizinische Universität zu Lübeck
EU contribution
No data
Address
160,Ratzeburger Allee
23538 Lübeck
Germany

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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

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Participants (6)

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