This task is about developing a generic approach to quantify the impact of a medical device on an environment in terms of EMI. Both contributions and reactions, subsequent to being placed in an environment, are addressed. The novel concept of “EMI footprint” comprises a set of characteristic curves obtained from stand-alone measurements on a device. It is combined with a statistical approach making it possible to combine the extra reactions a device can have with a system. Evaluating this footprint allows us to characterize beforehand EM environments for diverse scenarios. TUe will lead this task. During secondments, ESR1 will assess the EMI-footprint of imaging devices (MRI and X-Ray) at PHC while working together with ESR2, ESR3 and ESR4 on a complete risk identification. Scalability aspects of the EMI-footprint will be tested within the CIMA hospital.
This task is about characterizing EMI in scenarios where new digital communication systems (DCS) (including IoT) are being deployed together with medical devices. Standard testing procedures only measure the EMI frequency spectrum, which is not enough to perform a comprehensive evaluation of the performance degradation caused by multiple interferences. Hence, such EMI risks cannot be properly estimated. Figure of Merit (FoM) for DCS will be evaluated in the time domain. The resulting evaluation is based on statistical metric figures that meaningfully link a DCS to its reconfigurable environment. UPC will lead for this task. During secondments, ESR2 will measure “Figure of Merit for DCS” with novel time-domain EMI measurements in two types of medical environment: imaging systems (PHC) and in transportation with driver-monitoring systems (FIC). In PHC, ESR2 will work together with ESR1, ESR3 and ESR4 on a complete risk identification.
The ESR will study the application of the recently proposed and revolutionary hazard-and-risk-analysis methods STAMP (System-Theoretic Accident Model and Processes) and STPA (System-Theoretic Process Analysis) to the EMI risk analysis of medical applications. Starting from the concepts out of Systems Thinking and Systems Theory, STAMP. STPA reformulate safety as a system-control problem rather than simply component-failure problems. However, so far, EMI robustness has not been looked at with STAMP/STPA. Therefore, the aim of this ESR is to integrate EMI into these techniques and apply this to two case-studies from different medical-application domains during secondments. The results of the STAMP/STPA analysis will be compared to those obtained with the classic hazard-and-risk-analysis methods (FTA, FMEA). KUL will lead for this task, the integration of EMI into the STAMP/STPA will be applied to integrated medical imaging systems (MRI and X-ray) in PHC where ESR1, ESR2, and ESR4 will work together on a complete risk identification. A second application will be performed on wearable body sensors in PLUX.
This task develops an EMI-aware design process starting from the risk and hazard analyses of the medical system-under-development in its operational electromagnetic environment. The system and environment are divided into tangible items at lower subsystem levels (i.e., use of zoning), which are transferred to the design process by means of an EMI risk-management plan (EMI-RMP). Based upon the EMI-RMP, the most effective EMC measures will be chosen and implemented. The EMI-RMP borrows state-of-the-art configuration management from system engineering to establish and maintain the system’s performance throughout its full life-cycle, including future upgrades or modifications. Finally, the EMI-RMP will be used as the input for an EMI-aware verification and validation process. The EMI-RMP will be logged and reviewed and if needed checked by an independent authority. UT will lead this task. Two EMI-RMPs will be developed for two real-life medical environments during secondment for the case of imaging systems (X-Ray) in PHC, where ESR4 will work closely with ESR 1, ESR2 and ESR 3 on a complete risk identification. The case of wearable body sensors will be addressed at PLUX.
This task develops a methodology to select the best possible DCS and its optimal scheme in harsh medical electromagnetic environments. An important type of EMI in medical scenarios is broadband impulsive noise disturbances that propagate as radiated signals, affecting digital communication receivers as in-band interferences. Procedures and algorithms will be proposed to improve the electromagnetic immunity of medical devices through the appropriate selection and configuration of their DCS, for a diverse operational electromagnetic environment. Real-time observation of the communication channel allows an adaptive approach in the selection of an EMI-resilient DCS. UPC will lead this task. Because of the complementarity of their approach, ESR5 and ESR6 will work together during both their secondments. In KUL, ESR5 will reinforce the process of definition and design of algorithms for selection of the appropriate DCS and improve the immunity, while a secondment in PMC will be necessary to test such algorithms on cold-plasma healing devices.
Many technological innovations in medical applications will rely on distributed sensors and (wireless) communication networks. This brings major safety and reliability challenges as there will be more reliance on the (wireless) interconnections to operate reliably for all scenarios, and this over the system’s entire life-cycle. As such, it is necessary to guarantee the connectivity’s robustness, taking into account a combination of stresses, including EMI disturbances, environmental conditions, aging, etc. For complex distributed sensor and communication networks, this can only be achieved by a holistic approach that covers at the same time the software, middleware and hardware layers. Therefore, this ESR-project aims to develop novel software, middleware and hardware techniques to obtain fault-tolerant and/or fault-operation behaviour for the overall system-of-systems. KUL will lead this task. Because of the complementarity of their approach, ESR5 and ESR6 will work together during their secondments. ESR6 will investigate in UPC techniques developed for systems-of-systems types of structure. A study test case will be made with cold-plasma healing devices (PMC).
In an EMI risk-based approach, medical devices would need to be tested before deployment, while taking into account the environment in which they will be placed. It is, however, often not possible to recreate complex in-situ scenarios involving, for instance, large equipment from other manufacturers. This approach will consist of establishing equivalent reconfigurable simple structures that reproduce key couplings, as seen from the device under test while deployed. It makes it possible to test diverse, identified risks of couplings and interactions before deployment. The validation of the risk assessment would be made possible for diverse scenarios. TUe will lead this task. An equivalent risk-based EMI testing within the integrated imagining system of PHC will be tested at UMCU (ESR7 will work closely with ESR11 in a common secondment). A second case will be investigated at FIC with an on-board bio-sensing platform of wearable bio-sensing devices.
This task will define new tests to evaluate the immunity of digital communication systems in the presence of complex electromagnetic disturbances. Current medical devices work and communicate inside an increasingly complex electromagnetic environment that includes, besides the traditional disturbances, multiple or cumulative interference sources, and impulsive noise. To protect these medical systems, it is necessary to test beyond the conventional standards to evaluate properly the effect of electromagnetic interferences on digital communication systems. This task focuses on the definition of new immunity-testing procedures that consider at the same time multiple, cumulative and impulsive interference sources. UPC will lead this task. A first secondment at FIC will make it possible to verify, adjust and validate the new immunity-testing procedures within a driver-monitoring system. And PLUX on wearables sensor platforms (2nd secondment).
This task will build sensors that can continuously monitor the real EMI disturbances that a medical device encounters during its operational life. First, the bit error rate (BER) of one or multiple communication channels will be tracked to estimate the EMI. Second, the amplitude of harmonics will be monitored in the frequency domain. Initially, these options will be assessed based on simulations, after which they will be validated in practice. The sensors will be fabricated and validated as stand-alone sensors. After that they will be integrated into a system to validate their final effectiveness. KUL will lead this task, extra knowledge will be gained, and a first prototype will be tested, during a first secondment at UT. A second secondment will allow further intensive testing on wearables sensor platforms in PLUX.
This task is about identifying extra system-specific tests to be performed in addition to the existing and formalized EMI characterization of single systems, before integration. System-of-system integration, such as integrating MRI and PET, typically takes place at the site of the clinical researchers. The system needs to be certified (e.g., CE), which includes an EMC assessment and underlying proof. Due to the collaborative way of working and on-site installation, testing can take place only at the component level or in-situ. It is known that in-situ measurements are cumbersome and often not unreliable, therefore a better method for assessing EMC performance and managing EMC risk has to be developed. PHC will lead this task. In a first secondment at UMCU, performances in terms of EMI on an integrated system-of-system will be investigated (in close collaboration with ESR11). Time-domain evaluation techniques will be explored in KUL (in close collaboration with ESR6) in another secondment. A last secondment is planned at UT to combine solutions with an EMI risk-management plan (EMI-RMP) (in close collaboration with ESR4).
This task is about the study of the correlation between EMC test results in an open environment versus EMC test results in a full reflective environment and versus EMC test results in representative use clinical settings (lead test bay, outpatient clinic, etc.). EMC test results are studied at the Unit, Subsystem and System level and the results will be key for the risk-based approach process with inputs in the following documents: EMC risk management, EMC Risk Control and EMC Compliance lines. The correlations will, in a second stage, be expanded to predict EMC emission levels of configuration permutations with the individual unit and subsystem test results. PHC will lead this task. During a first secondment, EMC tests in representative clinical settings will be performed at UMCU (in close collaboration with ESR10). A second secondment at TUe will make it possible to link EMC test results in a full reflective environment with uncertainty values (in close collaboration with ESR12). In a last secondment EMC tests will be performed in a hospital environment (CIMA) and proposed equivalences between environments will be evaluated.
Modern driver-monitoring systems require measuring the real-time physiological parameters of drivers to assess their physical and attention state. Those monitoring systems are very important in autonomous vehicles when returning the human driving functionalities. The measurement of such signals represents a challenge in a crowded electromagnetic scenario such as a modern vehicle. Connected vehicles use many wireless technologies: LTE, Bluetooth, NFC, 4G and 5G, etc. Meanwhile hybrid /electric vehicles are a new challenge regarding EMI due to the generation of low-frequency disturbances. Both types of interference can simultaneously affect the correct operation of the new driver-monitoring systems. This task is about evaluating the effect of the cumulative EMI in the monitoring systems and defining the tests to check the correct operation and to ensure the reliability of the future automotive ADAS. FIC will lead this task. During a first secondment at TUe it will be possible to link the cumulative EMI in the monitoring system with a full reflective environment and with its uncertainty values (in close collaboration with ESR12). Tests to characterize adequately cumulative EMI in the monitoring systems will be further investigated in a second secondment in EUF (in close collaboration with ESR13).
Adapting wearable technology into a medical device takes a long certification process, which is highly demanding for an SME, due to a lack of intrinsic design and production methodologies to mititate EMI. This task is about developing new process guidelines to include EMI management in product design, prototyping and production in wireless wearable sensor technologies, which facilitate compliance with quality and safety, improving the time-to-market. An example from PLUX will be selected to follow a complete innovation process, to implement novel mechanisms improving EMI risk, quality and development time. Knowledge on base sensing principles used in the medical devices industry to study the production process will be applied. In a later stage, contents will be produced in the format of tutorials that will guide developers of new clinical applications through the EMI assessment of new wireless wearable medical devices. PLUX will lead this task. During a first secondment at FCT, appropriate EM-mitigation design techniques for bio-sending devices will be investigated and listed. These EMI mitigation design techniques will be validated during tests at EUF (in close collaboration with ESR12).
In the end, both the EMC and Medical Directives require the manufacturer to clearly document all steps taken and decisions made to guarantee and check the conformity of the product in the so-called Technical Documentation. The purpose of the Technical Documentation is to make it possible for an external independent, external assessor or for the final user to (i) reproduce the whole reasoning followed by the manufacturer, (ii) assess the conformity of the product as well as (iii) get an overview of all (design) measures that were needed to get to that conformance or any assumptions that there might concerning the use or installation of the product. Unfortunately, there is no standardized way to write down the Technical Documentation. As a result, Technical Documentation can look very different, making it quite difficult to interpret and follow them. Looking outside of the field of EMC, standardized notations to structure and present arguments are available. More specifically, different types of graphical notations have been developed for safety assurance cases for safety critical systems, such as the Goal Structuring Notation (GSN), the Claims-Arguments-Evidence (CAE) notation and very recently the Structured Assurance Case Metamodel (SACM) language. In this task, the use of these graphical notations for documenting the overall EMC assessment of medical equipment is explored in depth, leading to a set of EMC assurance case patterns or templates. KUL will lead this task. During the first secondment an EMC Assurance case will be developed for a collaborative MRI system (PHC) and during the second secondment on an on-board sensing platform (FIC).