Automated Testsystem of COGNISION(TM) Headset for Cognitive Diagnosis.

摘要

There are more than 15 million Americans suffering from a chronic cognitive disability in the Unites States. Researchers have been exploring many different quantitative measures, such as event related potentials (ERP), electro-encephalogram (EEG), Magnetic Encephalogram (MEG) and Brain volumetry to accurately and repeatedly diagnose patients suffering from debilitating cognitive disorders. More than a million cases have been diagnosed every year, with many of those patients being misdiagnosed as a result of inadequate diagnostic and quality control tools. As a result, the medical device industry has been actively developing alternative diagnostic techniques, which implement one or more quantitative measures to improve diagnosis. For example, Neuronetrix (Louisville, KY) developed COGNISION(TM) that utilizes both ERP and EEG data to diagnose the cognitive ability of patients. The system has shown to be a powerful tool; however, its commercial success would be limited without lack of a fast and effective method of testing and validating the product. Thus, the goal of this study is to develop, test and validate a new "Testset" system for accurately and repeatedly validating the COGNISION(TM) Headset.;A Testset was constructed that is comprised of a software control component designed using the Labview G programming language, which runs on a computer terminal, a Data Acquisition (DAQ) card and switching board. The Testset is connected to a series of testing fixtures for interfacing with the various components of the Headset. The Testset evaluates the Headset at multiple stages of the manufacturing process as a whole system or by its individual components. At the first stage of production the Electrode Strings, amplifier board (Uberyoke), and Headset Control Unit (HCU) are tested and operated as individual printed circuit boards (PCBs). These components are again tested as mid-level assemblies and/or at the finished product stage as a complete autonomous system with the Testset monitoring the process. All tests are automated, requiring only a few parameters to be defined before a test is initiated by a single button press, and then selected test sequences are begun for that particular component or system and are completed in a few minutes.;A total of 2 Testsets were constructed and used to validate 10 Headsets. An automated software system was designed to control the Testset. The Testset demonstrated the ability to validate and test 100% of the individual components and completed assembled Headsets. The Testsets were found to be within 5% of the manufacturing specifications. Subsequently, the Automated Testset developed in this study enabled the manufacturer to provide a comprehensive report on the calibration parameters of the Headset, which is retained on file for each unit sold. The automated test system's statistical analysis shows that the two Testsets yielded reliable and consistent results with each other.