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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.

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UNLABELLED: A modified 3-element windkessel model was applied to study the relationship between brachial arterial blood pressure and the photoplethysmographic waveform from pulse oximeters. Data were recorded from 12 healthy volunteers who underwent the oxygen desaturation study. During about 30 minutes recording period, the SpO2 value was regulated down till about 70%. After preprocessing, singular value decomposition (SVD) algorithm was then used to get the best fit of the model parameters. RESULT: the fitting error (RMSE) was 1.07 +/- 0.48 mmHg. The time constant of the model shown significant difference between the highest and the lowest saturation group.

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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.

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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.

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This study aimed to investigate and compare the performance of the algorithms contained in the newest generation of pulse oximeters (Masimo SET in IVY2000, Nellcor Oxismart N-3000, Agilent M3 rev. B) against a traditional pulse oximeter (Agilent CMS rel. A.0). The benchmark was performed in an efficient and reproducible way in the laboratory environment using patient signal recordings complemented by a two-hand volunteer motion test. A novel method of creating artifact/reference signal pairs from a clinical database, the noise-mix-composition (NMC), was developed. The new method enabled the simulation of critical clinical situations in a more realistic way than the usual two hand volunteer studies. An advantage of the laboratory tests over live clinical studies was that a continuous saturation reference was available, allowing accurate on-going determination of the SpO2 error. A new quantitative performance measure, the non-performance index (NPI), was developed and applied to the benchmark results. It covers the 3 performance aspects of a pulse oximeter: (1) SpO2 accuracy, (2) pulse rate accuracy and (3) drop out times. These factors were weighted according to clinical importance determined by a survey. During the restricted conditions of steady state and forced motion test on healthy volunteers Masimo/Ivy's pulse oximeter performed best with a 2.6 fold improvement over the conventional technology. Clear improvements were also found for Agilent's M3 (1.6 fold) and Nellcor's N-3000 (1.6 fold). In contrast, the clinically oriented NMC study yielded the best performance improvement--as measured in NPI numbers--for Agilent's M3 rev. B (1.6 fold) and due to more frequent SpO2 errors only 1.5 for Masimo and 1.3 for N-3000. A large difference was found for the dropout rate: the lowest was achieved by Masimo (3.0% of total time), the largest by Nellcor N-3000 (24.1% of total time), a factor which was rated high by clinicians. Very pronounced improvements (between 2.3 and 3.4 fold) on all of the newer devices were found for the pulse rate. The NMC turned out to be a very useful tool for generating a standard signal set for algorithm development and benchmarking purposes that eliminates repetitive clinical testing in early stages. The applicability of its results needs confirmation by clinical live studies.

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UNLABELLED: The electroencephalogram (EEG) and middle latency auditory evoked responses (MLAER) have been proposed for assessment of the depth of anesthesia. However, a reliable monitor of the adequacy of anesthesia has not yet been defined. In a multicenter study, we tested whether changes in the EEG and MLAER after a tetanic stimulus applied to the wrist could be used to predict subsequent movement in response to skin incision in patients anesthetized with 1 minimum alveolar anesthetic concentration (MAC) isoflurane in N2O. We also investigated whether the absolute values of any of these variables before skin incision was able to predict subsequent movement. After the induction of anesthesia with propofol and facilitation of tracheal intubation with succinylcholine, 82 patients received 1 MAC isoflurane (0.6%) in N2O 50% without an opioid or muscle relaxant. Spontaneous EEG and MLAER to auditory click-stimulation were recorded from a single frontoparietal electrode pair. MLAER were severely depressed at 1 MAC isoflurane. At least 20 min before skin incision, a 5-s tetanic stimulus was applied at the wrist, and the changes in EEG and MLAER were recorded. EEG and MLAER values were evaluated before and after skin incision for patients who did not move in response to tetanic stimulation. Twenty patients (24%) moved after tetanic stimulation. The changes in the EEG or MLAER variables were unable to predict which patients would move in response to skin incision. Preincision values were not different between patients who did and did not move in response to skin incision for any of the variables. MLAER amplitude increased after skin incision. We conclude that it is unlikely that linear EEG measures or MLAER variables can be of practical use in titrating isoflurane anesthesia to prevent movement in response to noxious stimulation. IMPLICATIONS: Reliable estimation of anesthetic adequacy remains a challenge. Changes in spontaneous or auditory evoked brain activity after a brief electrical stimulus at the wrist could not be used to predict whether anesthetized patients would subsequently move at the time of surgical incision.

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Considering the fundamental difficulties to define the term 'depth of anaesthesia', a more feasible concept for assessment of 'adequacy of anaesthesia' will be explained. The basic requirements for a monitoring index are definite response, gradual scaling and independence from the anaesthetic technique used. Additionally the index should be predictive for appearance of clinical signs of an inadequate anaesthesia. Different signal-processing methods will be discussed to extract the relevant information from both the spontaneous and the evoked brain electrical activity. In this context well established methods like spectral analysis are investigated in combination with new and more sophisticated methods like bispectral analysis or wavelet decomposition. Since no single-parameter index has been defined for monitoring depth of anaesthesia, a set of EEG parameters may be more useful to take into account intra- and interindividual variability. In parallel to the description of the monitor concept, the investigation of neural nets and fuzzy techniques, in addition to or in substitution of conventional statistical methods, will be introduced. Examples are given for data quality assessment, parameter extraction and re-classification.

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Thermography enables the measurement of patients skin temperature profiles without stress caused by direct contact of probes to the skin. In previous incubator studies, frontal recordings were made through a hole in the top wall of the incubator hood. Using this method it is not possible to record the lateral temperature gradient from the back to the abdomen of the infant (in supine position), which is due to very limited heat loss near the incubator mattress. In this study temperature recordings were made from a lateral position. For this purpose a new front door of the incubator (Draeger 8000) was designed, which replaced the standard front door during measurements. In a clinical study thermography was compared to temperature measurements by standard thermistors. The mean difference between thermography and thermistors was 0.16 degree C. These results verify the use of thermography for measuring skin temperature of preterm infants in incubators.

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A prerequisite for the further improvement in the quality of warming therapy is an accurate knowledge of the interactions between the microclimate in warming therapy devices and the thermal balance of the infant. For generating this knowledge, thermal manikins can be helpful. Suitable models capable of also simulating evaporative heat loss in preterm infants have, however, not been available to date. A thermal manikin representing an infant weighing 530 g and capable of simulating convective, radiative and also evaporative heat loss has now been developed. It comprises an outer shell made of porous, anatomically shaped clay, and is divided into six compartments each of which can be heated individually. Water-filled Gore-Tex bags located immediately beneath the shell are provided to simulate evaporation. In a clinical study, temperature profiles of 8 very small preterm infants were measured thermographically. Measurements in the manikin showed that highly comparable temperature profiles with only minor differences could be obtained. Total heat and water losses by the manikin were in good agreement with clinical values. Using the model described here it is possible to simulate the heat exchange of premature infants under extreme and accurately reproducible environmental conditions. This manikin may thus serve as a tool for comparative studies, for the development of warming therapy equipment, or for training purposes.

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The present paper examined the question as to the extent to which the taking of gas samples for the purpose of measuring the breath alcohol concentration (BAC) in the expired air of patients on artificial respiration is influenced by temperature and humidity. For this purpose a lung model standardized at different alcohol concentrations was used, in which the temperature (T: 25, 30 and 35 degrees C) and the relative humidity (RH: 50, 75 and 95%) were varied.

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