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U.S. Department of Health and Human Services

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FY 2000 Physiological Signal Acquisition, Analysis, And Control Systems

The signal acquisition system of a medical device is the electronic circuitry and control processor that receives, as inputs, signals from biological, chemical, mechanical, or electric-field sensors that are within or attached to the human body. These signals are processed in subsequent decision-making circuitry within the device. The interpreted signal can be used as a monitor or warning signal or to control a responding mechanism. Examples include cochlear implants, fetal oximetry, and home uterine activity monitors. The fidelity with which a physiologic signal is captured is often critical to the overall performance of a medical device. In FY 2000, OST participated in over 40 IDE, PMA, and 510(k) reviews, for devices including cochlear implants, pacemakers, fetal oximeters, implantable defibrillators, gas analyzers, ventilator support systems, apnea monitors, and resuscitators, where the signal acquisition system and associated electronics were the subject of the review.

Laboratory Design/Staff Development
Key words: signal acquisition, electronics

OST staff members are involved in an ongoing project to upgrade the instrumentation in the CDRH X-ray calibration laboratory. They have developed a new architecture, involving a network of microprocessor-based controllers, which has significant reliability and performance advantages over the existing system. In FY 2000, much of the infrastructure for this system was developed and the first of the new controllers, the shutter controller, was deployed on both the main radiography and the mammography x-ray systems.

OST’s Division of Physical Sciences (DPS) developed a course in biomedical engineering for the CDRH Staff College. The course consisted of eight lectures, each with an associated case study. An OST engineer developed two of the eight case studies, covering analog amplifiers and data acquisition principles. The goal of the training was to relate the concepts of biomedical engineering to real-world regulatory issues.