Abstract
The safety improvements in the medical systems or devices, specifically non-invasive
patient monitoring systems (PMS) and point-of-care (POC) devices of human health monitoring
(HHMS) systems, are in great need to perform precise measurements of vital parameters with
uninterrupted continuous monitoring for diagnosis of significant human health ailments. During
critical or non-critical nursing times, frequent monitoring of short and long-duration measures of
vital parameters (like ECG, EEG, Respiratory, SpO2, Blood-pressure, Temperature, etc.) and
non-vital parameters (like Glucose levels, Hemoglobin, Urea in blood, etc.) will allow for better
nursing and early detection of diseases like cardiovascular diseases, respiratory diseases, liver
dysfunction, diabetes, renal diseases, and other psychological disorders. A non-invasive medical
instrumentation system for accomplishing these tasks must meet several criteria like accuracy
and precision of the measurement, reduction of false alarms, effective detection of faults, and
fault tolerance to systemic or random failures with an uninterrupted performance during nursing
times.
Many research groups have made many efforts worldwide to make strategies and guidelines
and standardize the procedures for medical systems based on safety design approaches to raise
alerts for any deviance during non-invasive monitoring of health parameters. In addition, health
monitoring instruments should be portable, low-cost, and reliable over time. Many modes of
diagnosis and related instrument maintenance procedures satisfy these criteria. However, most of
them are still in the improvement stage for developing resilient instruments for integrating with
critical auto-robotic surgery instruments with minimal human intervention.
Several approaches have been proposed, out of which safety-related design approaches like
using 2oo2, 2oo3, 1oo2, etc., along with AI-based data analytics, have the advantage of meeting
these rigorous demands in fundamental safety improvements of Medical Systems. Based on the
safety-related design 2oo2 concept, a configurable system prototype of the cardiac health
monitoring system (CHMS) is developed and evaluated to meet the set objectives, such as fault detection effectiveness and fault tolerance with improved safety configurability. This
configurable system uses various sensors to collect the bio-medical data in parallel. Primarily,
three diverse sensors are used non-invasively in sensing the bio-signals in different forms like
electric potential, light, and sound signals for computations. These diverse sensors are used to
detect biomedical signals to obtain data from electrocardiogram (ECG), Photo-plethysmogram
(PPG), and Phonocardiogram (PCG). Therefore, the accuracy of the vital estimates and the
fundamental safety improvements were evaluated using this multimodal system with AI-based
fault detection and predictive maintenance techniques.
Traditional statistical and AI-based techniques have acquired authentic measurements of
human health parameters from diverse signals received simultaneously from various sensing
circuits like PPG/ECG/EEG. Secondly, these bio-signals are calibrated independently with
known algorithms in diverse. Finally, these obtained parameters, along with the built-in-test
(BIT) system for health signals, are processed with implemented safety functions, and the
algorithms to generate the correct human health parameters and prognosticate abnormalities of
human health 200 patients were available for instrument evaluation trials for HR parameter
monitoring and tested after taking informed consent. A MATLAB-based CHMS tool is
developed for configurable and then implemented on a field-programmable gate array (FPGA) to
minimize the designed circuitry with improved resiliency of the instrument system. The CHMS
has been configured to 2oo2 with the selected HR parameter to estimate the system's availability
and health. The collected HR output was subjected to data analytics against individually
collected data. We found a significant reduction in the generation of unimportant alarms and
increased uninterruptable System availability by 45% to 55%, along with normal and abnormal
artifact data. The measured normal artifacts are more than 99% accurate and are used for
prognosis. The abnormal data is used for edge-AI-based analytics to infer the system's health for
prescriptive maintenance. An experimental study has been carried out to effectively segregate
normal and abnormal signals in 2oo2 and 2oo3 configurations. A detailed analysis is carried out
in various sensor configurations as proposed. Similarly, in the 2oo3 configuration, we
significantly improved the system's availability from 55% to 95% by eliminating spurious alarms
with reduced downtime and improved accurate data vital parameters.
Further, a reliability assessment is performed on CHMS on identified parameters, such as
measuring Avai