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Wearable Flexible Hybrid Electronics Monitor for Recording Human Biometrics
Keywords: flexible hybrid electronics, medical device, wearable ECG monitor
We report on our effort to develop a wearable human monitor based on flexible hybrid electronics (FHE) for recording, communicating and analyzing biometric parameters. This effort has produced a 2�x2� premanufacturing prototype that delineates the materials, components and processes required for subsequent manufacturing. The prototype was fabricated with standard materials and components that have a well-established supply chain, and all processes were executed on manufacturing assembly lines or standardized equipment. The prototype was used to record human ECG signals and was fabricated on a Kapton� polyimide base polymer film. Both sides of the substrate have photolithographically patterned Cu features connected through the substrate with copper plated through-hole vias. The ECG electrodes and connecting traces are printed using Au ink, and the thermistor, for sensing skin temperature is printed using NiO nanoparticles with Au traces. Torsion testing of printed traces showed no degradation after 1,000 cycles at +/- 30 degrees. Surface mounted electronic components were attached using low temperature solder. ECG signals were subjected to analog processing that included band-pass filtering and amplification. The processed analog signal is digitized with 12-bit resolution by a system-on-chip (SoC) with onboard memory and a BlueTooth communication module that includes balun chip, antenna and other peripheral components. The thermistor signal is inputted directly into one of the SoC�s ADCs. The BlueTooth host performs all analyses. Thermistors were shown to have a sensitive linear response over the required temperature range. Archived certified clinical ECG signals were used to test the prototype�s performance with respect to signal shape, peak detection and the calculation of four clinical parameters; the prototypes� signals and calculated parameters on the BlueTooth host all compared favorably with the corresponding certified signals. The archived signals also verified prototype operation as a function of bend testing; no signal degradation was observed after 200 cycles using a 4� radius of curvature mandrel. Preliminary human trials showed the ability to record ECG signals comparable to those recorded using clinical Ag/AgCl electrodes and commercial ECG equipment. Strong ECG signals were demonstrated with the electrodes located in diagonally opposed corners of the prototype. An area of the chest with strong ECG signals and minimal bending was identified over the lower left rib cage, and appropriate responses to mild exercise by the subject were demonstrated. Further, human trials, thermistor calibration and more detailed engineering testing are ongoing. Sponsored by: The FlexTech Alliance�s NanoBio Manufacturing Consortium and the Air Force Research Laboratory
James N. Turner,
Binghamton University
Vestal, New York
USA


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