RESUMO
OBJECTIVE: There is no commonly accepted in vivo calibration method for pulse oximeters available up to now. On the basis of a prototype device for the calibration of pulse oximeters which was introduced recently, a second approach based on the same concept was tackled in order to design a reliable method for standardized calibration of pulse oximeters. METHODS: An extensive clinical database of time-resolved optical transmission spectra of patient fingers is used to simulate the behavior of patients. A device which is capable of playing back these spectroscopic data to pulse oximeters, and a database where the oxygen status measured with the reference method (Co-Oximetry) is stored, are the main parts of the concept. The playback device has an artificial finger as interface to the pulse oximeters and serves to collect light from the pulse oximeter for analysis and to playback simulated light to the pulse oximeter. The light intensity emitted by two LEDs which illuminates the pulse oximeter detector is controlled via a computer in such a way that it is the same as if the pulse oximeter light had passed the finger. The pulse oximeter display during the data playback can thus be compared to the true SaO2 of the patient. The device is tested with 4 pulse oximeters based on 100 patient spectra. RESULTS: For the four pulse oximeters used in this investigation, an Agilent Technologies CMS monitor (formerly Hewlett-Packard), an Ivy 2000 with Masimo Set technology and Nellcor N-3000 and N-395, there is good correlation between SPO2 and SaO2, and mean and standard deviation of in vivo SpO2-SaO2 and playback SpO2-SaO2 are in good agreement. For two instruments, Nellcor N3000 and Agilent CMS Monitor, a quantitative comparison between the in vivo and in vitro SpO, results was derived. A mean of the deviation playback vs. in vivo SpO2 is less than 0.5% SpO2. The error limits are comparable with the calibration error of the conventional calibration routine. The device is also capable of data playback even in situations with rapid desaturation changes, as displayed in Figure 2. For the other tested pulse oximeters the results are comparable. CONCLUSIONS: Compared to the first prototype the current version is simpler and less expensive in production. Many of previously existing problems are solved and the applicability to a large variety of pulse oximeters and sensors is given. The novel concept for the calibration of pulse oximeters is a tool for assessing the performance of pulse oximeters.
Assuntos
Oximetria/instrumentação , Calibragem , Desenho de Equipamento , HumanosAssuntos
Oximetria/normas , Europa (Continente) , Feminino , Humanos , Masculino , Análise MultivariadaRESUMO
The performance of a new calibrator for pulse oximeters is tested with five pulse oximeters from different manufacturers. The calibrator is based on time resolved transmission spectra of human fingers. Finger spectra with different arterial oxygen saturation can be selected to simulate real patients. The results obtained with this calibration device are compared with the results of conventional calibration procedures with volunteers. Beside accuracy tests the suitability for artifact simulation with the new device is discussed. The response of the five tested pulse oximeters is in good agreement with the response of the pulse oximeters connected to real patients. A test procedure for pulse oximeters similar to the conventional desaturation practice is possible; some of the typical artifacts pulse oximetry has to cope with can be simulated easily.
Assuntos
Desenho de Equipamento , Oximetria/normas , Calibragem , HumanosRESUMO
OBJECTIVE: To develop and test a method for standardized calibration of pulse oximeters. METHODS: A novel pulse oximeter calibration technique capable of simulating the behavior of real patients is discussed. It is based on an artificial finger with a variable spectral-resolved light attenuator in conjunction with an extensive clinical database of time-resolved optical transmission spectra of patients fingers in the wavelength range 600-1000 nm. The arterial oxygen saturation of the patients at the time of recording was derived by analyzing a corresponding blood sample with a CO-oximeter. These spectra are used to compute the modulation of the light attenuator which is attached to the artificial finger. This calibration method was tested by arbitrarily playing back recorded spectra to pulse oximeters and comparing their display to the value they displayed when the spectra were recorded. RESULTS: We were able to demonstrate that the calibrator could generate physiological signals which are accepted by a pulse oximeter. We also present some experience of playing back recorded patient spectra. The mean difference between the original reading of the pulse oximeters and the display when attached to the calibrator is 1.2 saturation points (displayed oxygen saturation SpO2) with a standard deviation of 1.9 saturation points. CONCLUSIONS: The tests have shown the capabilities of a spectral light modulator for use as a possible calibration standard for pulse oximeters. If some improvements of the current prototype can be achieved we conclude from the experience with the device that this novel concept for the calibration of pulse oximeters is feasible and that it could become an important tool for assessing the performance of pulse oximeters.