A. Field of the Invention
The actual invention includes methods for the validation of physiological data, acquired in two or more parts of the human body by sensors connected to a medical device, for the statistical validation and comparison of the relationship among the signals retrieved by said medical devices, in order to select information that increases the accuracy of the study being carried out. The purpose of the actual invention is to make this data available for use by protocols or reference values, according to the field of application.
B. Background of the Invention
One of the concerns of the people involved in the health sector is the reliability of the results provided by medical devices using physiological data acquired in two or more parts of the human body. This is due to the fact that most of the values visually retrieved by the operator through a medical device interface are not filtered to distinguish between reliable values and values resulting from errors in measurements, in addition to the absence of a reliable comparison between the data acquired by sensors in two or more parts of the body.
This means that the statistical certainty of the study decreases if data collection is made visually and the information is not statistically validated to make sure that the acquired physiological data is comparable.
Additionally, the time spent in acquiring said data and the amount of analyzed data vary and are contingent upon the operator's experience and criteria. In other words, the operator decides the time at which the system stability or data certainty is acceptable and proceeds to obtain the required values. However, this decision is subjective and may lead to errors in the reported results.
A medical device for acquiring physiological data in two or more parts of the human body may be, for example, a physiological monitor for obtaining oxygen saturation values from a patient, where said physiological monitor may comprise: two or more LED light-emitting/receiving sensors connected to a corresponding pulse oximeter at one or more USB communication ports, and a computer in communication with the USB interface. In order to increase reliability of the measurement results of said physiological monitor, it is necessary to validate, firstly by the medical device, that the connections of the pulse oximeter sensors to the computer exist in order to be able to proceed to the retrieval and analysis of physiological data from said locations.
If said validation is not made, measurement anomalies, highly capable of generating low certainty level results and, thus, dubious interferences and potentially erroneous diagnoses, may not be identified.
In view of the needs described above, the applicant has developed a method for the acquisition and validation of physiological data for the incorporation thereof to medical devices, said method allows the comparison of physiological data acquired in two or more parts of the body and the inference of the system stability in order to provide certainty to the results of the study being carried out.
By the use of the method of the actual invention, it is possible to validate and compare the fact that the signals retrieved by medical devices provide data with high statistical certainty.