Abstract
Progress in science and technology has given rise to the development of a broad range of medical devices for prophylaxis, diagnosis, and treatment of various diseases and organization of public health service. This is mainly due to active use of computers in medical research, biomedical engineering, and public health service [4, 12]. Both functional and consumer properties of modern medical devices are determined by the efficiency of software and algorithmic support [18, 51]. Devices and systems for functional diagnosis constitute an important class of medical devices. This is primarily due to their mass-scale use. In addition, this class of medical devices for a variety of causes was found to be an appropriate model for testing new ideas in biomedical engineering. A broad spectrum of interpretation electrocardiographic devices have been developed in recent years. Such devices are available from Hewlett-Packard (USA), Siemens (Germany), Schiller AG (Switzerland), Marquette (USA), and some other manufacturers. Some spirographs (e.g., Jaeger, Germany) also provide the function of interpretation. Usually, these devices are equipped with integral problem-oriented expert systems of different levels of complexity. The input information for these systems is obtained from analysis of instrumentally measured physiological signals. The main problems solved by the integral computer of the interpretation device include signal presentation quality control, analysis of signal elements, and interpretation in medical terms [10, 11, 22, 25, 37]. Software quality assessment in case of fundamentally nonlinear signal processing algorithms, sophisticated vocabulary of medical diagnostic conclusions, physiological variability of input signal, and inaccuracy of medical knowledge is a serious problem of development of interpretation medical devices [7, 31]. Thus, extensive use of computers in medical devices requires active development of the following directions: − algorithmic software; − quality control of devices based on sophisticated software.
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