Periodic Reporting for period 1 - ETERNITY (European Training Network on Electromagnetic Risks in Medical Technology)
Reporting period: 2021-03-01 to 2023-02-28
Electromagnetic interference (EMI) is a growing concern also in the medical-technology industry, as it can disrupt communications and pose risks to patients, especially with life-support systems. The recent Blue Guide, which outlines EU product rules, has made a risk-based approach to EMI mandatory for new equipment. However, many companies and users in the industry, including hospitals, are struggling with this approach due to a lack of understanding and clear risk-assessment methodology. Small and medium-sized enterprises (SMEs) make up a significant portion of the industry and may face challenges in adapting to this shift. The ETERNITY project aims to create a multidisciplinary network for doctoral training, involving leading industries and academia, to address EMI risks in the design of innovative medical equipment such as wearables, on-board platforms, and collaborative care systems for hospitals. The goals of ETERNITY include proposing solutions to scientific challenges, training young pioneers in electronic design for medical technology, building an industry-academia network, and enabling safe and reliable medical equipment innovation in various environments.
Summary per Researcher (up to M24)
ESR 1:
-Bringing attention to the use of reverberation chambers in industry as a fast and cost-effective method for radiated emission measurements above 1 GHz.
-Raising awareness and improving understanding of the relatively new, risk-based product regulations and distinguishing them from the old, rule-based standards.
-Conducting experimental investigations into the risk-based EMI footprint of a deployed MedTech product.
ESR 3:
-Development of a decision-making algorithm to deal with EMI-induced errors in Hamming-based communications.
-Extension of STPA to include EMI-related risks and its application.
ESR 4:
-Explored the risk-based EMC approach and electromagnetic environment (EME) measurement methods relevant to hospital environments.
-Application of the identified techniques in different environments using different measurement techniques and devices.
ESR 5:
-Identification of the various digital systems that operate in environments where there are significant electromagnetic interferences
-Analysis of the radio communication link in the presence of transient interference.
ESR 6:
-Establishing a two-node connection between a transmitter and a receiver to transmit and receive bits on the physical layer.
-A new method called New-Hamming, which combines Triple Modular Redundancy (TMR) and Hamming methods to improve the resilience of a communication system
ESR 7:
-Overview of techniques for EM environment characterization and in situ tests.
-General Framework ensuring Taylor made test suites with sampling strategy performance evaluation.
ESR 8:
-Development of a new method to perform a radiated immunity test with initial MATLAB simulations to analyse the parameters and the algorithm behaviour.
-Application of a pre-distortion method to the input signals to reduce the non-linearity introduced by the system and equipment in the test setup.
ESR 9:
-Software-defined radios (SDRs) are configured as a platform to develop a frequency-selective detector. SDRs are being used as frequency-selective EMI detectors for generating a warning when an anomaly occurs.
-Characterization and classification of a medical device setup failures.
ESR 10:
-Definition of the scope of risk-based EMC for MRI systems.
-Characterization of the MRI electromagnetic environment.
ESR11:
-The trends in use of systems in medical technology and implications to EMC were studied for understanding why risk-based EMC approach is becoming more relevant
-EM environment characterization with the development of an appropriate measurement system including hardware and software components.
ESR12:
-Analysis of Cumulative EMI on different parts
-User case study on a real in-cabin monitoring system.
ESR13:
-Characterization and validation of new electrodes with regards to their usability for ECG acquisition using gelled Ag/AgCl electrodes as a reference and a biosignalsplux hub as the acquisition device
-Characterization of the mechanism of how the interference would entry the instrumentation amplifier as differential and common mode voltage.
ESR14:
-Development of Goal Structuring Notation (GSN) patterns for compliance, risk, and EM resilience
-Development of a risk case framework during secondment.
ESR 1:
-Bringing attention to the use of reverberation chambers in industry as a fast and cost-effective method for radiated emission measurements above 1 GHz.
-Raising awareness and improving understanding of the relatively new, risk-based product regulations and distinguishing them from the old, rule-based standards.
-Conducting experimental investigations into the risk-based EMI footprint of a deployed MedTech product.
ESR 3:
-Development of a decision-making algorithm to deal with EMI-induced errors in Hamming-based communications.
-Extension of STPA to include EMI-related risks and its application.
ESR 4:
-Explored the risk-based EMC approach and electromagnetic environment (EME) measurement methods relevant to hospital environments.
-Application of the identified techniques in different environments using different measurement techniques and devices.
ESR 5:
-Identification of the various digital systems that operate in environments where there are significant electromagnetic interferences
-Analysis of the radio communication link in the presence of transient interference.
ESR 6:
-Establishing a two-node connection between a transmitter and a receiver to transmit and receive bits on the physical layer.
-A new method called New-Hamming, which combines Triple Modular Redundancy (TMR) and Hamming methods to improve the resilience of a communication system
ESR 7:
-Overview of techniques for EM environment characterization and in situ tests.
-General Framework ensuring Taylor made test suites with sampling strategy performance evaluation.
ESR 8:
-Development of a new method to perform a radiated immunity test with initial MATLAB simulations to analyse the parameters and the algorithm behaviour.
-Application of a pre-distortion method to the input signals to reduce the non-linearity introduced by the system and equipment in the test setup.
ESR 9:
-Software-defined radios (SDRs) are configured as a platform to develop a frequency-selective detector. SDRs are being used as frequency-selective EMI detectors for generating a warning when an anomaly occurs.
-Characterization and classification of a medical device setup failures.
ESR 10:
-Definition of the scope of risk-based EMC for MRI systems.
-Characterization of the MRI electromagnetic environment.
ESR11:
-The trends in use of systems in medical technology and implications to EMC were studied for understanding why risk-based EMC approach is becoming more relevant
-EM environment characterization with the development of an appropriate measurement system including hardware and software components.
ESR12:
-Analysis of Cumulative EMI on different parts
-User case study on a real in-cabin monitoring system.
ESR13:
-Characterization and validation of new electrodes with regards to their usability for ECG acquisition using gelled Ag/AgCl electrodes as a reference and a biosignalsplux hub as the acquisition device
-Characterization of the mechanism of how the interference would entry the instrumentation amplifier as differential and common mode voltage.
ESR14:
-Development of Goal Structuring Notation (GSN) patterns for compliance, risk, and EM resilience
-Development of a risk case framework during secondment.
ESR1 The concept of “EMI footprint” will combine tests to obtain characteristic curves for the impact of a stand-alone device on an environment, with an additional statistical approach which will make it possible to combine extra reactions occurring within a complex medical scenario.
ESR2 Novel time-domain EMI measurements and analysis methods will be developed to establish the relationship between measurement results and the behaviours of DCS.
ESR3 Robustness against EMI will be evaluated using the most recent and revolutionary hazard-and-risk-analysis methods (STAMP and STPA) based on system thinking and system theory.
ESR4 A proper formalization and management of the EMC risk-based design process of medical systems will be developed and validated.
ESR5 A mathematical underpinning of EMI reduction techniques (real-time monitoring, re-configurability of DCS) will lead to a new level of performance for diverse scenarios.
ESR6 Combined EMI-aware hardware, middleware and software measures will be approached holistically to achieve systems that are inherently EMI-resilient throughout their full life cycle.
ESR7 The risk-based test approach will use reconfigurable structures that mimic post-deployment couplings experienced by the device under test, aiming to test diverse identified risks of couplings and interactions.
ESR8 To evaluate for diverse scenarios the immunity of digital communication systems in complex electromagnetic scenarios, new tests will be defined: multiple coexistent disturbances will be considered with the use of multipath test scenarios.
ESR9 Low-cost EMI sensors will be developed to continuously monitor the disturbances experienced by the medical device during its actual deployment.
ESR10 Additional system-specific tests are added to existing EMI characterization of single systems to evaluate the performance of combined systems. This eliminates the need for extensive and unreliable in-situ tests during the verification and validation of systems-of-systems developed jointly at the customer's site.
ESR11 Study of the correlation between three EMC test results: in an open environment, in a full reflective environment and in representative use clinical settings. This will make it possible to predict unintended interactions between medical systems.
ESR12 An evaluation of the effect of the cumulative EMI in monitoring systems will be made and based on that, tests will be developed to check the correct operation and to ensure the reliability of the future automotive driver-monitoring systems.
ESR13 Novel process guidelines to include EMI management in product design, prototyping and production in wireless wearable sensor technologies, which will facilitate compliance with quality and safety, improving the time-to-market.
ESR14 will use advanced graphical notations such as GSN, CAE, and SACM from safety-critical systems to create EMC assurance case templates summarizing all measures taken to address EMI-related risks.
ESR2 Novel time-domain EMI measurements and analysis methods will be developed to establish the relationship between measurement results and the behaviours of DCS.
ESR3 Robustness against EMI will be evaluated using the most recent and revolutionary hazard-and-risk-analysis methods (STAMP and STPA) based on system thinking and system theory.
ESR4 A proper formalization and management of the EMC risk-based design process of medical systems will be developed and validated.
ESR5 A mathematical underpinning of EMI reduction techniques (real-time monitoring, re-configurability of DCS) will lead to a new level of performance for diverse scenarios.
ESR6 Combined EMI-aware hardware, middleware and software measures will be approached holistically to achieve systems that are inherently EMI-resilient throughout their full life cycle.
ESR7 The risk-based test approach will use reconfigurable structures that mimic post-deployment couplings experienced by the device under test, aiming to test diverse identified risks of couplings and interactions.
ESR8 To evaluate for diverse scenarios the immunity of digital communication systems in complex electromagnetic scenarios, new tests will be defined: multiple coexistent disturbances will be considered with the use of multipath test scenarios.
ESR9 Low-cost EMI sensors will be developed to continuously monitor the disturbances experienced by the medical device during its actual deployment.
ESR10 Additional system-specific tests are added to existing EMI characterization of single systems to evaluate the performance of combined systems. This eliminates the need for extensive and unreliable in-situ tests during the verification and validation of systems-of-systems developed jointly at the customer's site.
ESR11 Study of the correlation between three EMC test results: in an open environment, in a full reflective environment and in representative use clinical settings. This will make it possible to predict unintended interactions between medical systems.
ESR12 An evaluation of the effect of the cumulative EMI in monitoring systems will be made and based on that, tests will be developed to check the correct operation and to ensure the reliability of the future automotive driver-monitoring systems.
ESR13 Novel process guidelines to include EMI management in product design, prototyping and production in wireless wearable sensor technologies, which will facilitate compliance with quality and safety, improving the time-to-market.
ESR14 will use advanced graphical notations such as GSN, CAE, and SACM from safety-critical systems to create EMC assurance case templates summarizing all measures taken to address EMI-related risks.