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 Currently available pulse oximeters use different unpublished and often untested algorithms.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. Fields of science medical and health sciencesclinical medicineanaesthesiology Programme(s) FP4-SMT - Specific research and technological development programme in the field of standards, measurements and testing, 1994-1998 Topic(s) 01 - Measurements for quality European products Call for proposal Data not available Funding Scheme CSC - Cost-sharing contracts Coordinator Medizinische Universität zu Lübeck EU contribution No data Address 160,Ratzeburger Allee 23538 Lübeck Germany See on map Total cost No data Participants (6) Sort alphabetically Sort by EU Contribution Expand all Collapse all Ergo S.A. Greece EU contribution No data Address 15,AG Orous Street 15123 Athens See on map Total cost No data Fachhochschule Lübeck Germany EU contribution No data Address 3,Stephensonstraße 23562 Lübeck See on map Total cost No data Imperial College of Science, Technology and Medicine United Kingdom EU contribution No data Address Praed Street W2 1NY London See on map Total cost No data Instituto Oncologico de San Sebastian Spain EU contribution No data Address 44,Aldakoenea 20012 San Sebastián See on map Total cost No data Katholieke Universiteit Leuven Belgium EU contribution No data Address 49,Herestraat 3000 Leuven See on map Total cost No data Technological Educational Institutionof Athens Greece EU contribution No data Address Ag. Spiridonos Street 12210 Athens See on map Total cost No data
