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  • Devices designed primarily for automated discovery and/or ascertainment of the presence or existence (i.e., detection) of some physical, chemical, physiologic, or technical condition. Detectors are not intended for accurate measurement or display of the numerical values of the conditions that are detected, although they can provide rough estimates of those conditions and/or indicate when predetermined values have been reached or exceeded. These devices may include recorders and/or alarms. Most detectors are used in healthcare applications to indicate life-threatening conditions that may occur in medical device operation (e.g., bubble detection during intravenous infusion), to localize metals in the human body (especially in the eyes), or to determine the presence of certain physiologic vital signs (e.g., respiration, pulse). Other detectors can indicate the presence of hazardous environmental conditions (e.g., toxic agents, ionizing radiation, chemical or biological agents).
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