The short-wave infrared (SWIR) module of the Tropospheric Monitoring Instrument (TROPOMI) on board the ESA's Sentinel-5 precursor (S5p) satellite has been very stable during its 5 years in orbit. ...Calibration was
performed on the ground, complemented by measurements during in-flight instrument commissioning. The radiometric response and general performance of the SWIR module are monitored by on-board calibration sources. We show that after 5 years in orbit, TROPOMI-SWIR has continued to show excellent
performance with degradation of at most 0.1 % in transmission and having lost less than 0.3 % of the detector pixels. Independent validation of the instrument calibration, via vicarious calibration, can be done through comparisons with ground-based reflectance data. In this work, ground measurements at the Railroad Valley Playa, a valley in central Nevada that is often used as a reference for satellite measurements, are used to perform vicarious calibration of the TROPOMI-SWIR measurements. This is done using dedicated measurement campaigns as well as automated reflectance measurements within the RADCALNET programme. As such, TROPOMI-SWIR is an excellent test case to explore the methodology of vicarious calibration applied to infrared spectroscopy. Using methodology developed for the vicarious calibration of the OCO-2 and GOSAT missions, the absolute radiometry of TROPOMI-SWIR performance is independently verified to be stable down to ∼ 6 %–10 % using the Railroad Valley when both the absolute and relative radiometric calibrations are applied. Differences with the on-board calibration originate from the bidirectional reflection distribution function (BRDF) effects of the desert surface, the large variety in viewing angles, and the different sizes of footprints of the TROPOMI pixels. Vicarious calibration is shown to be an additional valuable tool in validating radiance-level performances of infrared instruments such as TROPOMI-SWIR in the field of atmospheric composition. It remains clear that for instruments of similar design and resolution to TROPOMI-SWIR, on-board calibration sources will continue to provide superior results due to the limitations of the vicarious calibration method.
The short-wave infrared (SWIR) module of the Tropospheric Monitoring Instrument (TROPOMI) on board the ESA's Sentinel-5 precursor (S5p) satellite has been very stable during its 5 years in orbit. ...Calibration was performed on the ground, complemented by measurements during in-flight instrument commissioning. The radiometric response and general performance of the SWIR module are monitored by on-board calibration sources. We show that after 5 years in orbit, TROPOMI-SWIR has continued to show excellent performance with degradation of at most 0.1 % in transmission and having lost less than 0.3 % of the detector pixels. Independent validation of the instrument calibration, via vicarious calibration, can be done through comparisons with ground-based reflectance data. In this work, ground measurements at the Railroad Valley Playa, a valley in central Nevada that is often used as a reference for satellite measurements, are used to perform vicarious calibration of the TROPOMI-SWIR measurements. This is done using dedicated measurement campaigns as well as automated reflectance measurements within the RADCALNET programme. As such, TROPOMI-SWIR is an excellent test case to explore the methodology of vicarious calibration applied to infrared spectroscopy. Using methodology developed for the vicarious calibration of the OCO-2 and GOSAT missions, the absolute radiometry of TROPOMI-SWIR performance is independently verified to be stable down to â¼ 6 %-10 % using the Railroad Valley when both the absolute and relative radiometric calibrations are applied. Differences with the on-board calibration originate from the bidirectional reflection distribution function (BRDF) effects of the desert surface, the large variety in viewing angles, and the different sizes of footprints of the TROPOMI pixels. Vicarious calibration is shown to be an additional valuable tool in validating radiance-level performances of infrared instruments such as TROPOMI-SWIR in the field of atmospheric composition. It remains clear that for instruments of similar design and resolution to TROPOMI-SWIR, on-board calibration sources will continue to provide superior results due to the limitations of the vicarious calibration method.
Introduction
The recent introduction of the European Medical Device Regulation poses stricter legislation for manufacturers developing medical devices in the EU. Many devices have been placed into a ...higher risk category, thus requiring more data before market approval, and a much larger focus has been placed on safety. For implantable and Class III devices, the highest risk class, clinical evidence is a necessity. However, the requirements of clinical study design and developmental outcomes are only described in general terms due to the diversity of devices.
Methods
A structured approach to determining the requirements for the clinical development of high‐risk medical devices is introduced, utilizing the question‐based development framework, which is already used for pharmaceutical drug development. An example of a novel implantable device for haemodialysis demonstrates how to set up a relevant target product profile defining the device requirements and criteria. The framework can be used in the medical device design phase to define specific questions to be answered during the ensuing clinical development, based upon five general questions, specified by the question‐based framework.
Results
The result is a clear and evaluable overview of requirements and methodologies to verify and track these requirements in the clinical development phase. Development organizations will be guided to the optimal route, also to abandon projects destined for failure early on to minimize development risks.
Conclusion
The framework could facilitate communication with funding agencies, regulators and clinicians, while highlighting remaining ‘known unknowns’ that require answering in the post‐market phase after sufficient benefit is established relative to the risks.
Objective: Hemodialysis patients usually receive an arteriovenous fistula (AVF) in the arm as vascular access conduit to allow dialysis 2-3 times a week. This AVF introduces the high flow necessary ...for dialysis, but over time the ever-present supraphysiological flow is the leading cause of complications. This study aims to develop an implantable device able to non-invasively remove the high flow outside dialysis sessions. Methods: The developed prototype features a magnetic ring allowing external coupling and torque transmission to non-invasively control an AVF valve. Mock-up devices were implanted into arm and sheep cadavers to test sizes and locations. The transmission torque, output force, and valve closure are measured for different representative skin thicknesses. Results: The prototype was placed successfully into arm and sheep cadavers. In the prototype, a maximum output force of 78.9 ± 4.2 N, 46.7 ± 1.9 N, 25.6 ± 0.7 N, 13.5 ± 0.6 N and 6.3 ± 0.4 N could be achieved non-invasively through skin thicknesses of 1-5 mm respectively. The fistula was fully collapsible in every measurement through skin thickness up to the required 4 mm. Conclusion: The prototype satisfies the design requirements. It is fully implantable and allows closure and control of an AVF through non-invasive torque transmission. In vivo studies are pivotal in assessing functionality and understanding systemic effects. Significance: A method is introduced to transfer large amounts of energy to a medical implant for actuation of a mechanical valve trough a closed surface. This system allows non-invasive control of an AVF to reduce complications related to the permanent high flow in conventional AVFs.
