Home Device- and service profiles for integrated or systems based on open standards
Article Open Access

Device- and service profiles for integrated or systems based on open standards

  • Alexander Mildner EMAIL logo , Armin Janß , Jasmin Dell’Anna-Pudlik , Paul Merz , Martin Leucker and Klaus Radermacher
Published/Copyright: September 12, 2015
Download Article (PDF)
Become an author with De Gruyter Brill
Author Information Explore this Subject
Current Directions in Biomedical Engineering
From the journal Current Directions in Biomedical Engineering Volume 1 Issue 1

Abstract

Integrated OR systems nowadays are closed and proprietary, so that the interconnection of components from third-party vendors is only possible with high time and cost effort. An integrated operating theatre with open interfaces, giving clinical operators the opportunity to choose individual medical devices from different manufacturers, is currently being developed in the framework of the BMBF (Federal Ministry of Education and Research) funded project OR.NET [1]. Actual standards and concepts regarding technical feasibility and accreditation process do not cope with the requirements for modular integration based on an open standard. Therefore, strategies as well as service and device profiles to enable a procedure for risk management and certifiability are in the focus of the project work. Amongst others, a concept for User Interface Profiles (UI-Profiles) has been conceived in order to describe medical device functions and the entire user interface regarding Human-Machine-Interaction (HMI) characteristics with the aim to identify human-induced risks of central user interfaces. The use of standardized device and service profiles shall allow the manufacturers to integrate their medical devices in the OR.NET network, without disclosing the medical devices’ risk analysis and related confidential knowledge or proprietary information.

Keywords: Accreditation strategies; medical device integration; dynamic interconnection; open standards, inter-operability; OR.NET project; risk management; usability engineering; service and device profiles

1 Introduction and background

The need for integration and interoperability of medical devices in the operating room (OR) and clinical environment is growing. The reason for this is, inter alia, the increasingly complex surgical equipment: the surgeons, anaesthetists and OR nurses often work highly cramped, stressed and have to deal with the operation of many different complex and, mostly complete independently working medical devices.

This can be solved e.g. by using an integrated workflow-adapted surgical and anaesthetic cockpit with interconnected medical devices. Today, this is only feasible by using isolated proprietary solutions from a single manufacturer. In this case the use of proprietary interfaces inhibits the general interchangeability of medical devices [2].

Therefore, the goal is the creation of an open standard, which allows an open and dynamic interconnection and integration of medical devices. This standardised, open and dynamic interconnection of medical devices is on the one hand a technical challenge and on the other hand a legitimate barrier. According to actual medical device directive 93/42 the hospital operator faces the trouble to be the producer/manufacturer of an open integrated OR system. Therefore, system manufacturer obligations concerning declaration of conformity should not be transferred to the operator, in order to keep the accreditation process practicable.

The OR.NET-project, funded by the federal ministry of education and research (BMBF), focuses on the safe, secure and dynamic interconnection of medical devices in the operating room and clinic on the basis of open standards. In the interface documentation, the protocol specification has to be addressed on the one hand, which however is not sufficient in the medical field due to regulatory requirements and necessary risk considerations. Rather also a documentation of the boundary conditions, requirements on the infrastructure and on the other side of the interface (the connected medical device(s)) must be available.

The necessary information shall be documented with the help of a device and service profile. This profile serves manufacturers to generically document information regarding the interface of the medical device and to provide information for potential network partners (medical devices) and the Operator.

2 State-of-the-art

Today’s concept of proprietarily interconnected medical devices follows the principle that the connection of two medical devices implies the creation of a medical device system, which regulatorily counts as a new medical device. In this case, one of the medical device manufacturers acts as a system producer and assumes the responsibility for the joint operation of the medical devices, declares conformity with the directive(s) and yet ensures the necessary requirements of risk management and usability assessment.

Several medical device manufacturers offer integrated operating systems based on proprietary interfaces, e.g. Karl Storz, Brainlab, Stryker, Maquet and Olympus. They only allow a combination of specific medical devices where outsider medical device manufacturers are not able to participate.

The actual approach concerning the accreditation process does not fit to the vision of dynamically interconnected open systems in Medical-IT networks. The integration of individual medical units by the operator would actually imply (according to medical device law) an in-house production regarding the integrated work system.

This situation forces clinic operators either to restrict themselves to the proprietary solution of one medical device manufacturer or to use stand-alone medical devices.

3 Approach

Because the dynamic interconnection has significant benefits for medical applications and state-of-the-art methods for the accreditation process are insufficient, a new approach for the conformity declaration and (technical and HMI-based) risk management has to be drawn up. First and foremost this includes methodological determination of new requirements and risks resulting from the ability of open integrated medical devices. Network-based risks as well as requirements concerning unknown network partners have to be documented in a standardized way. Our approach defines a device and service-profile, which includes all information necessary for a safe and reliable interconnection. The profile can be used by manufacturers of medical devices during the product development process to document the interface specifications and requirements for the OR-infrastructure.

When putting medical devices into service in an open network, the hospital operator compares the device- and service-profiles to verify the safe interconnection and communication of specific device pairings. This verification is performed in the form of a delta analysis of two device profiles, as shown in Figure 1.

Figure 1 Delta-analysis for open Integration
Figure 1

Delta-analysis for open Integration

The device and service-profile should address five topics of concern, which should be documented and are derived in the following subchapters.

3.1 Intended use and corresponding risk analysis

According to Directive 93/42 / EEC for medical devices, an intended use has to be defined and documented by the manufacturer. The intended use documents the medical purpose and function of a medical device. When interconnecting medical devices in a network, it turns out, that in most cases the (medical) intended use of the original medical devices is not affected; neither the main functions of the medical devices, derived from the intended use, are changed.

The network consists merely in other technical realization of functions: e.g. instead of using the foot switch of a cutting device, an integrated foot switch, which fulfils the safety requirements (regarding technical and HMI-based risks) for controlling a cutting device is used, so input or output devices are replaced by another.

For the benefit due to interconnecting medical devices, the (technical) intended use of the interconnection must be documented, which is considered to be an extension of the original (technical) intended use of the device. This extension includes the intended use of the service or the device in the cross-linked system with other interconnected services or devices and the type of data exchange.

In order to control one medical device function by another, the documentation of the development process as well as the software of the influencing device must, if applicable, be adjusted to the requirements of the risk class of the influenced medical device.

According to DIN EN ISO 14971 standard: “Application of risk management to medical devices” [3], for every medical device and system of medical devices a risk analysis regarding patient or user harm, which is based on the intended use and functions of the medical device, has to be performed. Residual risks derived from the risk analysis must be weighed against the clinical benefits. This risk analysis has to be checked for delta changes when cross-linking medical devices. If there are changes on the medical intended use and the necessary functions have to meet this intended use, this has to be included in the risk analysis.

3.2 Technical description of interface

When interconnecting medical devices, a comparison of the specifications of the components used to implement the functions and the protocol specification has to be assured. Only when mutually the specification requirements are met, devices can be connected. An interconnection of medical devices over a hospital IT network is necessarily based on a network-technology (here Ethernet), so that it is possible to describe the technical specifications regarding transmission in a structured interface description. Thus, if mutually communication (transmission and receipt) according to the interface description is ensured, a safe networking capability can be assumed.

The definition and standardization of the technical interface specification is another focus of the OR.NET-project. The technical OR.NET interface description is based on the IEEE 11073 medical device communication standard and currently has the status of a draft.

The draft consists firstly of general device information, such as data model version, which is implemented in the device, and device information of the MDS (Medical Device System) descriptor (e.g. model-no, model name, serial No, manufacturer, friendly name, UDI). Secondly, the medical device has to be described technically. The data model dissects a medical device system (MDS) into subparts to metrics, which are atomic (such as a single parameter, value, ...). Thus, the technical specifications provide a model of the medical device and describe the medical device as presented in the network.

3.3 User interface profiles

UI-Profiles allow the manufacturers to integrate their medical devices, respectively the provided functions regarding HMI requirements, into the OR.NET network. The UI Profiles allow both an automated optimized selection and composition of various user interfaces, and implicitly an optimal design of a central GUI with respect to the criteria of usability and an integrated human risk analysis [4]. The core of the UI-Profiles are attributes (e.g. characteristics of input and output devices as well as GUI interaction elements, human information processing factors, environmental and process factors, task-specific factors) and the dependencies of the attributes, which are described in four matrices [5]: Generation/selection of interaction element and input device, visual presentation of information, acoustic information presentation and visual grouping.

Based on these matrices an integrated user interface can be evaluated and later be designed. The UI profiles are defined as additional information (criticality of functions, grouping of interaction elements, requirements for input and output devices, etc.) in the technical device profile (including identification, type, subtype, functions, manufacturer, etc.).

3.4 Technical risk management

In medical device and software development, risk management is obligatory. Besides that, since in most cases the medical intended use and the corresponding risk analysis do not or only marginally change, when making a medical device interoperable it is reasonable to also perform a technical risk analysis regarding two domains:

Hazards concerning changed parts, components and software modules of a medical device: Hazards, which occur during the development of an interconnectable medical product, however, on the one hand lead to infrastructure requirements and on the other hand lead to device-internal security measures.

Infrastructure requirements have to be documented in the device and service-profile as network requirements.

Internal security measures have to be implemented during the development process of the medical device and should be completed when declaring conformity. Due to the internal nature of the security measures, they must be communicated in exceptional cases when they produce requirements for the communication partner, which cannot be mutually intercepted on the communication protocol level.

Hazards concerning the interconnection and communication over an IT-Network:

When integrating medical devices over a Medical IT-Network (MIT-Network), hazards arising from the interconnection have to be considered. In general, devices are not exclusively connected directly and bilaterally. In the MIT-Network are also other medical and non-medical devices and possibly various infrastructure components involved in the communication. Through these influences, various error possibilities on the transmission path between the communication partners arise.

For this reason, security measures have to be defined which allow, if necessary, the inference of a message transmission and receipt. These security measures must be communicated between the network partners, as they are only useful if both sides meet them or at least the recipient of a message can handle the safety measure. Therefore, it is useful to present these measures in the device and service-profile. The profile is also available for the hospital operator, who is responsible for establishing the interconnection. The compliance of the safety measures has to be checked prior to establishment of this interconnection; only with positive outcome in the pre-tests, the interconnection is verified and legal.

According to applicable standards and regarding the protocol and data model of OR.NET, a list of communication based security measures have been defined: Sequence number, time stamp, encryption, authorization via certificate, response, 2-channel-transmission, safety-context and periodic data transfer. These security measures can be used stand-alone or combined, regarding the type of data, which is transferred.

3.5 Network requirements

From the technical risk analysis several requirements to the network are arising, which have to be documented and to be fulfilled for the correct and secure operation of the interconnected medical devices.

Since the operator must be aware of these requirements, they must be listed in the device and service-profile. When interconnecting medical devices in a MIT-network, the hospital operator has to ensure these network requirements, which have to meet every medical device demand. Only if the operator is able to provide the necessary network infrastructure in accordance with the fulfilment of the requirements of the medical devices, a secure interconnection can be guaranteed.

4 Conclusion

In this paper, accreditation aspects in the development process of open networked medical devices have been considered. The responsibilities for the development, production, operation and decommissioning as well as the conformity statement of open integrated medical devices have been addressed and the need of defined and standardized device and service profiles have been derived. Risk assessment possibilities have been developed for open medical work systems. Consequently, hazards concerning changed parts, components and software modules of a medical device must be secured by the manufacturers internal risk measures similar to today’s medical device development process; hazards concerning the interconnection of medical devices and communication over an IT-network must be communicated in the device and service profiles. Examples of infrastructure requirements have been defined.

For interoperable medical devices a structured and standardized interface description of the capabilities and requirements are essential. A documentation in the form of device and service profiles seems reasonable to meet this requirement.

Furthermore, it will be necessary to elaborate device and service profiles regarding the creation of device classes. The process of accreditation documentation regarding the delta of the device and service-profiles has to be produced exemplarily for different device combinations. Finally, all developed information and procedures regarding the device and service-profiles (including UI profiles) should be formally described for incorporation in a software supported process model in order to achieve automatic use.

Author's Statement

  1. Conflict of interest: Authors state no conflict of interest. Material and Methods: Informed consent: Informed consent has been obtained from all individuals included in this study. Ethical approval: The research related to human use has been complied with all the relevant national regulations, institutional policies and in accordance the tenets of the Helsinki Declaration, and has been approved by the authors’ institutional review board or equivalent committee.

References

[1] M. Birkle; J. Benzko; N. Shevchenko: Das Projekt OR.NET - Sichere dynamische Vernetzung in OP und Klinik, Zeitschrift für klinische Forschung, Innovation & Praxis, Vol. 11/12, 2012, pp. 41-45, 2012.Search in Google Scholar

[2] F. Kuehn, M. Leucker & A. Mildner: OR.NET - Approaches for Risk Analysis and Measures of Dynamically Interconnected Medical Devices – In 5th Workshop on Medical Cyber-Physical Systems: OASIcs, Vol. 36, pp. 133-136, Schloss Dagstuhl-Leibniz-Zentrum fuer Informatik, 2014.Search in Google Scholar

[3] DIN EN ISO 14971: Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012.Search in Google Scholar

[4] J. Benzko, A. Janß, J. Dell’Anna & K. Rademacher: Man-Machine Interfaces in the Operating Room - In Proceedings of the 48th DGBMT Annual Conference, Vol. 59, pp. 430, 2014.Search in Google Scholar

[5] A. Janß, J. Benzko, P. Merz, J. Dell’Anna, M. Strake & K. Radermacher. Development of Medical Device UI-Profiles for Reliable and Safe Human-Machine-Interaction in the Integrated Operating Room of the Future - Proceedings of the 5th International Conference on Applied Human Factors and Ergonomics 2014, pp. 1855-1860, 2014.10.54941/ahfe100507Search in Google Scholar

Published Online: 2015-9-12
Published in Print: 2015-9-1

© 2015 by Walter de Gruyter GmbH, Berlin/Boston

This article is distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Articles in the same Issue

  1. Research Article
  2. Development and characterization of superparamagnetic coatings
  3. Research Article
  4. The development of an experimental setup to measure acousto-electric interaction signal
  5. Research Article
  6. Stability analysis of ferrofluids
  7. Research Article
  8. Investigation of endothelial growth using a sensors-integrated microfluidic system to simulate physiological barriers
  9. Research Article
  10. Energy harvesting for active implants: powering a ruminal pH-monitoring system
  11. Research Article
  12. New type of fluxgate magnetometer for the heart’s magnetic fields detection
  13. Research Article
  14. Field mapping of ballistic pressure pulse sources
  15. Research Article
  16. Development of a new homecare sleep monitor using body sounds and motion tracking
  17. Research Article
  18. Noise properties of textile, capacitive EEG electrodes
  19. Research Article
  20. Detecting phase singularities and rotor center trajectories based on the Hilbert transform of intraatrial electrograms in an atrial voxel model
  21. Research Article
  22. Spike sorting: the overlapping spikes challenge
  23. Research Article
  24. Separating the effect of respiration from the heart rate variability for cases of constant harmonic breathing
  25. Research Article
  26. Locating regions of arrhythmogenic substrate by analyzing the duration of triggered atrial activities
  27. Research Article
  28. Combining different ECG derived respiration tracking methods to create an optimal reconstruction of the breathing pattern
  29. Research Article
  30. Atrial and ventricular signal averaging electrocardiography in pacemaker and cardiac resynchronization therapy
  31. Research Article
  32. Estimation of a respiratory signal from a single-lead ECG using the 4th order central moments
  33. Research Article
  34. Compressed sensing of multi-lead ECG signals by compressive multiplexing
  35. Research Article
  36. Heart rate monitoring in ultra-high-field MRI using frequency information obtained from video signals of the human skin compared to electrocardiography and pulse oximetry
  37. Research Article
  38. Synchronization in wireless biomedical-sensor networks with Bluetooth Low Energy
  39. Research Article
  40. Automated classification of stages of anaesthesia by populations of evolutionary optimized fuzzy rules
  41. Research Article
  42. Effects of sampling rate on automated fatigue recognition in surface EMG signals
  43. Research Article
  44. Closed-loop transcranial alternating current stimulation of slow oscillations
  45. Research Article
  46. Cardiac index in atrio- and interventricular delay optimized cardiac resynchronization therapy and cardiac contractility modulation
  47. Research Article
  48. The role of expert evaluation for microsleep detection
  49. Research Article
  50. The impact of baseline wander removal techniques on the ST segment in simulated ischemic 12-lead ECGs
  51. Research Article
  52. Metal artifact reduction by projection replacements and non-local prior image integration
  53. Research Article
  54. A novel coaxial nozzle for in-process adjustment of electrospun scaffolds’ fiber diameter
  55. Research Article
  56. Processing of membranes for oxygenation using the Bellhouse-effect
  57. Research Article
  58. Inkjet printing of viable human dental follicle stem cells
  59. Research Article
  60. The use of an icebindingprotein out of the snowflea Hypogastrura harveyi as a cryoprotectant in the cryopreservation of mesenchymal stem cells
  61. Research Article
  62. New NIR spectroscopy based method to determine ischemia in vivo in liver – a first study on rats
  63. Research Article
  64. QRS and QT ventricular conduction times and permanent pacemaker therapy after transcatheter aortic valve implantation
  65. Research Article
  66. Adopting oculopressure tonometry as a transient in vivo rabbit glaucoma model
  67. Research Article
  68. Next-generation vision testing: the quick CSF
  69. Research Article
  70. Improving tactile sensation in laparoscopic surgery by overcoming size restrictions
  71. Research Article
  72. Design and control of a 3-DOF hydraulic driven surgical instrument
  73. Research Article
  74. Evaluation of endourological tools to improve the diagnosis and therapy of ureteral tumors – from model development to clinical application
  75. Research Article
  76. Frequency based assessment of surgical activities
  77. Research Article
  78. “Hands free for intervention”, a new approach for transoral endoscopic surgery
  79. Research Article
  80. Pseudo-haptic feedback in medical teleoperation
  81. Research Article
  82. Feasibility of interactive gesture control of a robotic microscope
  83. Research Article
  84. Towards structuring contextual information for workflow-driven surgical assistance functionalities
  85. Research Article
  86. Towards a framework for standardized semantic workflow modeling and management in the surgical domain
  87. Research Article
  88. Closed-loop approach for situation awareness of medical devices and operating room infrastructure
  89. Research Article
  90. Kinect based physiotherapy system for home use
  91. Research Article
  92. Evaluating the microsoft kinect skeleton joint tracking as a tool for home-based physiotherapy
  93. Research Article
  94. Integrating multimodal information for intraoperative assistance in neurosurgery
  95. Research Article
  96. Respiratory motion tracking using Microsoft’s Kinect v2 camera
  97. Research Article
  98. Using smart glasses for ultrasound diagnostics
  99. Research Article
  100. Measurement of needle susceptibility artifacts in magnetic resonance images
  101. Research Article
  102. Dimensionality reduction of medical image descriptors for multimodal image registration
  103. Research Article
  104. Experimental evaluation of different weighting schemes in magnetic particle imaging reconstruction
  105. Research Article
  106. Evaluation of CT capability for the detection of thin bone structures
  107. Research Article
  108. Towards contactless optical coherence elastography with acoustic tissue excitation
  109. Research Article
  110. Development and implementation of algorithms for automatic and robust measurement of the 2D:4D digit ratio using image data
  111. Research Article
  112. Automated high-throughput analysis of B cell spreading on immobilized antibodies with whole slide imaging
  113. Research Article
  114. Tissue segmentation from head MRI: a ground truth validation for feature-enhanced tracking
  115. Research Article
  116. Video tracking of swimming rodents on a reflective water surface
  117. Research Article
  118. MR imaging of model drug distribution in simulated vitreous
  119. Research Article
  120. Studying the extracellular contribution to the double wave vector diffusion-weighted signal
  121. Research Article
  122. Artifacts in field free line magnetic particle imaging in the presence of inhomogeneous and nonlinear magnetic fields
  123. Research Article
  124. Introducing a frequency-tunable magnetic particle spectrometer
  125. Research Article
  126. Imaging of aortic valve dynamics in 4D OCT
  127. Research Article
  128. Intravascular optical coherence tomography (OCT) as an additional tool for the assessment of stent structures
  129. Research Article
  130. Simple concept for a wide-field lensless digital holographic microscope using a laser diode
  131. Research Article
  132. Intraoperative identification of somato-sensory brain areas using optical imaging and standard RGB camera equipment – a feasibility study
  133. Research Article
  134. Respiratory surface motion measurement by Microsoft Kinect
  135. Research Article
  136. Improving image quality in EIT imaging by measurement of thorax excursion
  137. Research Article
  138. A clustering based dual model framework for EIT imaging: first experimental results
  139. Research Article
  140. Three-dimensional anisotropic regularization for limited angle tomography
  141. Research Article
  142. GPU-based real-time generation of large ultrasound volumes from freehand 3D sweeps
  143. Research Article
  144. Experimental computer tomograph
  145. Research Article
  146. US-tracked steered FUS in a respiratory ex vivo ovine liver phantom
  147. Research Article
  148. Contribution of brownian rotation and particle assembly polarisation to the particle response in magnetic particle spectrometry
  149. Research Article
  150. Preliminary investigations of magnetic modulated nanoparticles for microwave breast cancer detection
  151. Research Article
  152. Construction of a device for magnetic separation of superparamagnetic iron oxide nanoparticles
  153. Research Article
  154. An IHE-conform telecooperation platform supporting the treatment of dementia patients
  155. Research Article
  156. Automated respiratory therapy system based on the ARDSNet protocol with systemic perfusion control
  157. Research Article
  158. Identification of surgical instruments using UHF-RFID technology
  159. Research Article
  160. A generic concept for the development of model-guided clinical decision support systems
  161. Research Article
  162. Evaluation of local alterations in femoral bone mineral density measured via quantitative CT
  163. Research Article
  164. Creating 3D gelatin phantoms for experimental evaluation in biomedicine
  165. Research Article
  166. Influence of short-term fixation with mixed formalin or ethanol solution on the mechanical properties of human cortical bone
  167. Research Article
  168. Analysis of the release kinetics of surface-bound proteins via laser-induced fluorescence
  169. Research Article
  170. Tomographic particle image velocimetry of a water-jet for low volume harvesting of fat tissue for regenerative medicine
  171. Research Article
  172. Wireless medical sensors – context, robustness and safety
  173. Research Article
  174. Sequences for real-time magnetic particle imaging
  175. Research Article
  176. Speckle-based off-axis holographic detection for non-contact photoacoustic tomography
  177. Research Article
  178. A machine learning approach for planning valve-sparing aortic root reconstruction
  179. Research Article
  180. An in-ear pulse wave velocity measurement system using heart sounds as time reference
  181. Research Article
  182. Measuring different oxygenation levels in a blood perfusion model simulating the human head using NIRS
  183. Research Article
  184. Multisegmental fusion of the lumbar spine a curse or a blessing?
  185. Research Article
  186. Numerical analysis of the biomechanical complications accompanying the total hip replacement with NANOS-Prosthetic: bone remodelling and prosthesis migration
  187. Research Article
  188. A muscle model for hybrid muscle activation
  189. Research Article
  190. Mathematical, numerical and in-vitro investigation of cooling performance of an intra-carotid catheter for selective brain hypothermia
  191. Research Article
  192. An ideally parameterized unscented Kalman filter for the inverse problem of electrocardiography
  193. Research Article
  194. Interactive visualization of cardiac anatomy and atrial excitation for medical diagnosis and research
  195. Research Article
  196. Virtualizing clinical cases of atrial flutter in a fast marching simulation including conduction velocity and ablation scars
  197. Research Article
  198. Mesh structure-independent modeling of patient-specific atrial fiber orientation
  199. Research Article
  200. Accelerating mono-domain cardiac electrophysiology simulations using OpenCL
  201. Research Article
  202. Understanding the cellular mode of action of vernakalant using a computational model: answers and new questions
  203. Research Article
  204. A java based simulator with user interface to simulate ventilated patients
  205. Research Article
  206. Evaluation of an algorithm to choose between competing models of respiratory mechanics
  207. Research Article
  208. Numerical simulation of low-pulsation gerotor pumps for use in the pharmaceutical industry and in biomedicine
  209. Research Article
  210. Numerical and experimental flow analysis in centifluidic systems for rapid allergy screening tests
  211. Research Article
  212. Biomechanical parameter determination of scaffold-free cartilage constructs (SFCCs) with the hyperelastic material models Yeoh, Ogden and Demiray
  213. Research Article
  214. FPGA controlled artificial vascular system
  215. Research Article
  216. Simulation based investigation of source-detector configurations for non-invasive fetal pulse oximetry
  217. Research Article
  218. Test setup for characterizing the efficacy of embolic protection devices
  219. Research Article
  220. Impact of electrode geometry on force generation during functional electrical stimulation
  221. Research Article
  222. 3D-based visual physical activity assessment of children
  223. Research Article
  224. Realtime assessment of foot orientation by Accelerometers and Gyroscopes
  225. Research Article
  226. Image based reconstruction for cystoscopy
  227. Research Article
  228. Image guided surgery innovation with graduate students - a new lecture format
  229. Research Article
  230. Multichannel FES parameterization for controlling foot motion in paretic gait
  231. Research Article
  232. Smartphone supported upper limb prosthesis
  233. Research Article
  234. Use of quantitative tremor evaluation to enhance target selection during deep brain stimulation surgery for essential tremor
  235. Research Article
  236. Evaluation of adhesion promoters for Parylene C on gold metallization
  237. Research Article
  238. The influence of metallic ions from CoCr28Mo6 on the osteogenic differentiation and cytokine release of human osteoblasts
  239. Research Article
  240. Increasing the visibility of thin NITINOL vascular implants
  241. Research Article
  242. Possible reasons for early artificial bone failure in biomechanical tests of ankle arthrodesis systems
  243. Research Article
  244. Development of a bending test procedure for the characterization of flexible ECoG electrode arrays
  245. Research Article
  246. Tubular manipulators: a new concept for intracochlear positioning of an auditory prosthesis
  247. Research Article
  248. Investigation of the dynamic diameter deformation of vascular stents during fatigue testing with radial loading
  249. Research Article
  250. Electrospun vascular grafts with anti-kinking properties
  251. Research Article
  252. Integration of temperature sensors in polyimide-based thin-film electrode arrays
  253. Research Article
  254. Use cases and usability challenges for head-mounted displays in healthcare
  255. Research Article
  256. Device- and service profiles for integrated or systems based on open standards
  257. Research Article
  258. Risk management for medical devices in research projects
  259. Research Article
  260. Simulation of varying femoral attachment sites of medial patellofemoral ligament using a musculoskeletal multi-body model
  261. Research Article
  262. Does enhancing consciousness for strategic planning processes support the effectiveness of problem-based learning concepts in biomedical education?
  263. Research Article
  264. SPIO processing in macrophages for MPI: The breast cancer MPI-SNLB-concept
  265. Research Article
  266. Numerical simulations of airflow in the human pharynx of OSAHS patients
https://doi.org/10.1515/cdbme-2015-0128
Keywords for this article
Accreditation strategies; medical device integration; dynamic interconnection; open standards, inter-operability; OR.NET project; risk management; usability engineering; service and device profiles
Creative Commons
BY-NC-ND 3.0

Articles in the same Issue

  1. Research Article
  2. Development and characterization of superparamagnetic coatings
  3. Research Article
  4. The development of an experimental setup to measure acousto-electric interaction signal
  5. Research Article
  6. Stability analysis of ferrofluids
  7. Research Article
  8. Investigation of endothelial growth using a sensors-integrated microfluidic system to simulate physiological barriers
  9. Research Article
  10. Energy harvesting for active implants: powering a ruminal pH-monitoring system
  11. Research Article
  12. New type of fluxgate magnetometer for the heart’s magnetic fields detection
  13. Research Article
  14. Field mapping of ballistic pressure pulse sources
  15. Research Article
  16. Development of a new homecare sleep monitor using body sounds and motion tracking
  17. Research Article
  18. Noise properties of textile, capacitive EEG electrodes
  19. Research Article
  20. Detecting phase singularities and rotor center trajectories based on the Hilbert transform of intraatrial electrograms in an atrial voxel model
  21. Research Article
  22. Spike sorting: the overlapping spikes challenge
  23. Research Article
  24. Separating the effect of respiration from the heart rate variability for cases of constant harmonic breathing
  25. Research Article
  26. Locating regions of arrhythmogenic substrate by analyzing the duration of triggered atrial activities
  27. Research Article
  28. Combining different ECG derived respiration tracking methods to create an optimal reconstruction of the breathing pattern
  29. Research Article
  30. Atrial and ventricular signal averaging electrocardiography in pacemaker and cardiac resynchronization therapy
  31. Research Article
  32. Estimation of a respiratory signal from a single-lead ECG using the 4th order central moments
  33. Research Article
  34. Compressed sensing of multi-lead ECG signals by compressive multiplexing
  35. Research Article
  36. Heart rate monitoring in ultra-high-field MRI using frequency information obtained from video signals of the human skin compared to electrocardiography and pulse oximetry
  37. Research Article
  38. Synchronization in wireless biomedical-sensor networks with Bluetooth Low Energy
  39. Research Article
  40. Automated classification of stages of anaesthesia by populations of evolutionary optimized fuzzy rules
  41. Research Article
  42. Effects of sampling rate on automated fatigue recognition in surface EMG signals
  43. Research Article
  44. Closed-loop transcranial alternating current stimulation of slow oscillations
  45. Research Article
  46. Cardiac index in atrio- and interventricular delay optimized cardiac resynchronization therapy and cardiac contractility modulation
  47. Research Article
  48. The role of expert evaluation for microsleep detection
  49. Research Article
  50. The impact of baseline wander removal techniques on the ST segment in simulated ischemic 12-lead ECGs
  51. Research Article
  52. Metal artifact reduction by projection replacements and non-local prior image integration
  53. Research Article
  54. A novel coaxial nozzle for in-process adjustment of electrospun scaffolds’ fiber diameter
  55. Research Article
  56. Processing of membranes for oxygenation using the Bellhouse-effect
  57. Research Article
  58. Inkjet printing of viable human dental follicle stem cells
  59. Research Article
  60. The use of an icebindingprotein out of the snowflea Hypogastrura harveyi as a cryoprotectant in the cryopreservation of mesenchymal stem cells
  61. Research Article
  62. New NIR spectroscopy based method to determine ischemia in vivo in liver – a first study on rats
  63. Research Article
  64. QRS and QT ventricular conduction times and permanent pacemaker therapy after transcatheter aortic valve implantation
  65. Research Article
  66. Adopting oculopressure tonometry as a transient in vivo rabbit glaucoma model
  67. Research Article
  68. Next-generation vision testing: the quick CSF
  69. Research Article
  70. Improving tactile sensation in laparoscopic surgery by overcoming size restrictions
  71. Research Article
  72. Design and control of a 3-DOF hydraulic driven surgical instrument
  73. Research Article
  74. Evaluation of endourological tools to improve the diagnosis and therapy of ureteral tumors – from model development to clinical application
  75. Research Article
  76. Frequency based assessment of surgical activities
  77. Research Article
  78. “Hands free for intervention”, a new approach for transoral endoscopic surgery
  79. Research Article
  80. Pseudo-haptic feedback in medical teleoperation
  81. Research Article
  82. Feasibility of interactive gesture control of a robotic microscope
  83. Research Article
  84. Towards structuring contextual information for workflow-driven surgical assistance functionalities
  85. Research Article
  86. Towards a framework for standardized semantic workflow modeling and management in the surgical domain
  87. Research Article
  88. Closed-loop approach for situation awareness of medical devices and operating room infrastructure
  89. Research Article
  90. Kinect based physiotherapy system for home use
  91. Research Article
  92. Evaluating the microsoft kinect skeleton joint tracking as a tool for home-based physiotherapy
  93. Research Article
  94. Integrating multimodal information for intraoperative assistance in neurosurgery
  95. Research Article
  96. Respiratory motion tracking using Microsoft’s Kinect v2 camera
  97. Research Article
  98. Using smart glasses for ultrasound diagnostics
  99. Research Article
  100. Measurement of needle susceptibility artifacts in magnetic resonance images
  101. Research Article
  102. Dimensionality reduction of medical image descriptors for multimodal image registration
  103. Research Article
  104. Experimental evaluation of different weighting schemes in magnetic particle imaging reconstruction
  105. Research Article
  106. Evaluation of CT capability for the detection of thin bone structures
  107. Research Article
  108. Towards contactless optical coherence elastography with acoustic tissue excitation
  109. Research Article
  110. Development and implementation of algorithms for automatic and robust measurement of the 2D:4D digit ratio using image data
  111. Research Article
  112. Automated high-throughput analysis of B cell spreading on immobilized antibodies with whole slide imaging
  113. Research Article
  114. Tissue segmentation from head MRI: a ground truth validation for feature-enhanced tracking
  115. Research Article
  116. Video tracking of swimming rodents on a reflective water surface
  117. Research Article
  118. MR imaging of model drug distribution in simulated vitreous
  119. Research Article
  120. Studying the extracellular contribution to the double wave vector diffusion-weighted signal
  121. Research Article
  122. Artifacts in field free line magnetic particle imaging in the presence of inhomogeneous and nonlinear magnetic fields
  123. Research Article
  124. Introducing a frequency-tunable magnetic particle spectrometer
  125. Research Article
  126. Imaging of aortic valve dynamics in 4D OCT
  127. Research Article
  128. Intravascular optical coherence tomography (OCT) as an additional tool for the assessment of stent structures
  129. Research Article
  130. Simple concept for a wide-field lensless digital holographic microscope using a laser diode
  131. Research Article
  132. Intraoperative identification of somato-sensory brain areas using optical imaging and standard RGB camera equipment – a feasibility study
  133. Research Article
  134. Respiratory surface motion measurement by Microsoft Kinect
  135. Research Article
  136. Improving image quality in EIT imaging by measurement of thorax excursion
  137. Research Article
  138. A clustering based dual model framework for EIT imaging: first experimental results
  139. Research Article
  140. Three-dimensional anisotropic regularization for limited angle tomography
  141. Research Article
  142. GPU-based real-time generation of large ultrasound volumes from freehand 3D sweeps
  143. Research Article
  144. Experimental computer tomograph
  145. Research Article
  146. US-tracked steered FUS in a respiratory ex vivo ovine liver phantom
  147. Research Article
  148. Contribution of brownian rotation and particle assembly polarisation to the particle response in magnetic particle spectrometry
  149. Research Article
  150. Preliminary investigations of magnetic modulated nanoparticles for microwave breast cancer detection
  151. Research Article
  152. Construction of a device for magnetic separation of superparamagnetic iron oxide nanoparticles
  153. Research Article
  154. An IHE-conform telecooperation platform supporting the treatment of dementia patients
  155. Research Article
  156. Automated respiratory therapy system based on the ARDSNet protocol with systemic perfusion control
  157. Research Article
  158. Identification of surgical instruments using UHF-RFID technology
  159. Research Article
  160. A generic concept for the development of model-guided clinical decision support systems
  161. Research Article
  162. Evaluation of local alterations in femoral bone mineral density measured via quantitative CT
  163. Research Article
  164. Creating 3D gelatin phantoms for experimental evaluation in biomedicine
  165. Research Article
  166. Influence of short-term fixation with mixed formalin or ethanol solution on the mechanical properties of human cortical bone
  167. Research Article
  168. Analysis of the release kinetics of surface-bound proteins via laser-induced fluorescence
  169. Research Article
  170. Tomographic particle image velocimetry of a water-jet for low volume harvesting of fat tissue for regenerative medicine
  171. Research Article
  172. Wireless medical sensors – context, robustness and safety
  173. Research Article
  174. Sequences for real-time magnetic particle imaging
  175. Research Article
  176. Speckle-based off-axis holographic detection for non-contact photoacoustic tomography
  177. Research Article
  178. A machine learning approach for planning valve-sparing aortic root reconstruction
  179. Research Article
  180. An in-ear pulse wave velocity measurement system using heart sounds as time reference
  181. Research Article
  182. Measuring different oxygenation levels in a blood perfusion model simulating the human head using NIRS
  183. Research Article
  184. Multisegmental fusion of the lumbar spine a curse or a blessing?
  185. Research Article
  186. Numerical analysis of the biomechanical complications accompanying the total hip replacement with NANOS-Prosthetic: bone remodelling and prosthesis migration
  187. Research Article
  188. A muscle model for hybrid muscle activation
  189. Research Article
  190. Mathematical, numerical and in-vitro investigation of cooling performance of an intra-carotid catheter for selective brain hypothermia
  191. Research Article
  192. An ideally parameterized unscented Kalman filter for the inverse problem of electrocardiography
  193. Research Article
  194. Interactive visualization of cardiac anatomy and atrial excitation for medical diagnosis and research
  195. Research Article
  196. Virtualizing clinical cases of atrial flutter in a fast marching simulation including conduction velocity and ablation scars
  197. Research Article
  198. Mesh structure-independent modeling of patient-specific atrial fiber orientation
  199. Research Article
  200. Accelerating mono-domain cardiac electrophysiology simulations using OpenCL
  201. Research Article
  202. Understanding the cellular mode of action of vernakalant using a computational model: answers and new questions
  203. Research Article
  204. A java based simulator with user interface to simulate ventilated patients
  205. Research Article
  206. Evaluation of an algorithm to choose between competing models of respiratory mechanics
  207. Research Article
  208. Numerical simulation of low-pulsation gerotor pumps for use in the pharmaceutical industry and in biomedicine
  209. Research Article
  210. Numerical and experimental flow analysis in centifluidic systems for rapid allergy screening tests
  211. Research Article
  212. Biomechanical parameter determination of scaffold-free cartilage constructs (SFCCs) with the hyperelastic material models Yeoh, Ogden and Demiray
  213. Research Article
  214. FPGA controlled artificial vascular system
  215. Research Article
  216. Simulation based investigation of source-detector configurations for non-invasive fetal pulse oximetry
  217. Research Article
  218. Test setup for characterizing the efficacy of embolic protection devices
  219. Research Article
  220. Impact of electrode geometry on force generation during functional electrical stimulation
  221. Research Article
  222. 3D-based visual physical activity assessment of children
  223. Research Article
  224. Realtime assessment of foot orientation by Accelerometers and Gyroscopes
  225. Research Article
  226. Image based reconstruction for cystoscopy
  227. Research Article
  228. Image guided surgery innovation with graduate students - a new lecture format
  229. Research Article
  230. Multichannel FES parameterization for controlling foot motion in paretic gait
  231. Research Article
  232. Smartphone supported upper limb prosthesis
  233. Research Article
  234. Use of quantitative tremor evaluation to enhance target selection during deep brain stimulation surgery for essential tremor
  235. Research Article
  236. Evaluation of adhesion promoters for Parylene C on gold metallization
  237. Research Article
  238. The influence of metallic ions from CoCr28Mo6 on the osteogenic differentiation and cytokine release of human osteoblasts
  239. Research Article
  240. Increasing the visibility of thin NITINOL vascular implants
  241. Research Article
  242. Possible reasons for early artificial bone failure in biomechanical tests of ankle arthrodesis systems
  243. Research Article
  244. Development of a bending test procedure for the characterization of flexible ECoG electrode arrays
  245. Research Article
  246. Tubular manipulators: a new concept for intracochlear positioning of an auditory prosthesis
  247. Research Article
  248. Investigation of the dynamic diameter deformation of vascular stents during fatigue testing with radial loading
  249. Research Article
  250. Electrospun vascular grafts with anti-kinking properties
  251. Research Article
  252. Integration of temperature sensors in polyimide-based thin-film electrode arrays
  253. Research Article
  254. Use cases and usability challenges for head-mounted displays in healthcare
  255. Research Article
  256. Device- and service profiles for integrated or systems based on open standards
  257. Research Article
  258. Risk management for medical devices in research projects
  259. Research Article
  260. Simulation of varying femoral attachment sites of medial patellofemoral ligament using a musculoskeletal multi-body model
  261. Research Article
  262. Does enhancing consciousness for strategic planning processes support the effectiveness of problem-based learning concepts in biomedical education?
  263. Research Article
  264. SPIO processing in macrophages for MPI: The breast cancer MPI-SNLB-concept
  265. Research Article
  266. Numerical simulations of airflow in the human pharynx of OSAHS patients
Sign up now to receive a 20% welcome discount
Institutional Access
How does access work?
Have an idea on how to improve our website?
Please write us.
© 2025 De Gruyter Brill
Downloaded on 8.9.2025 from https://www.degruyterbrill.com/document/doi/10.1515/cdbme-2015-0128/html
Scroll to top button