A Methodology for the Design of a Compliant Electrocardiograph: A Case Study

This document presents the methodology for designing an electrocardiograph capable of acquiring IEC 60601-2-25-compliant signals. The objective of developing this methodology is to address a signal incompatibility problem that has existed in academia for years, specifically in physiological processing research. This problem is related to the signal's sampling rate and/or noise levels, and it becomes evident when one signal processing method is intended to work with another, either as a subsequent or simultaneous process. Even though matching algorithms can be implemented to remedy this incompatibility problem, the ultimate solution is the standardization of signals, which depends exclusively on the standardization of hardware. The signal incompatibility problem is urgent to solve because it makes the integration and scalability of different academic works difficult, preventing academia from reaching the stage of development that commercial equipment displays in automatic interpretation procedures. The design methodology presented in this document addresses the stated problem by creating an open-source hardware device capable of acquiring compliant signals, with careful consideration given to Signal Integrity and EMC concepts-a methodology that can be extended to other physiological acquisition systems. The expedited availability of the device's design documentation and fabrication files is also an advantage of this work.