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[In 1976, as part of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, the term “medical device” was defined as:
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or...
[Before we can discuss the integration of system theory into medical devices, we need to define system theory. In this chapter, we present an extremely abbreviated description of system theory. For a more thorough treatment, please see Baura (2002b).]
[In this chapter, we describe four patient monitoring devices that use system theory to minimize the noise in their physiologic input signals. Since patient monitoring involves continuous observation and processing, a high signal-to-noise ratio is a critical first step to obtaining accurate...
[In this chapter, we describe a diagnostic device that uses system theory for classification. Since medical diagnostics involves discrete testing, it is imperative that this one-shot test result be accurate.]
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