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The X-ray must rank as one of the most significant innovations in the history of medical engineering and science. X-ray images are capable of providing crucial information about diseases and nowadays no modern emergency room would be without X-ray equipment. Over time, the demands placed on X-ray technology have been constantly changing, with attention currently being focused on achieving greater user-friendliness and better workflow productivity. Treatment should be as comfortable and as pleasant an experience for the patient as possible. Therefore, the X-ray system must be as flexible as possible when it comes to positioning patients, while also being easy to use and capable of delivering high-quality images that result in reliable diagnoses. Working for a major customer, infoteam Software GmbH and Pausch Technologies have developed complex, interactive operator control units for an innovative, ceiling-mounted X-ray system that boasts all these features.

An interdisciplinary team comprised of mechanical, electronics, and software specialists from the two Automation Valley companies was charged with planning, creating, testing, and commissioning the control and operating software for the X-ray system. A clear definition of roles made for particularly close, smooth cooperation at local level, with infoteam and Pausch acting as joint solution providers. infoteam was responsible for managing the control-software project, providing a highly-skilled team with a great deal of experience in Linux, graphical user interfaces, object-oriented programming, and TCP/IP communication. Pausch provided corresponding solutions and expertise as regards mechanics and electronics.

The project called for the development of logic to control six motorized axes; the equipment is also capable of executing automated sequences of movements (auto-positioning) and the apparatus is controlled by means of an intuitive user interface. Furthermore, the imaging and image-processing systems can communicate with one another. As the X-ray equipment is primarily used in the field of emergency medicine, it is extremely important that the system is a very reliable one.

 

The development process was subject to the stringent requirements of standard IEC 60601-1-4 for medical electrical equipment. This standard lays down strict specifications for the development process, from the risk analysis to the architecture, design, implementation, modification, verification, and validation of the software, and beyond to equipment identification. The infoteam developers implemented the requirements of IEC 60601-1-4 using the company’s own software development model, which has been certified to ISO 9001; the software requirements were derived from a cross-system risk analysis. The next step was for an interdisciplinary project steering committee to validate the requirements, the design, and the resulting test concept. The software functions were integrated into the hardware and the electronics during a period of intensive collaboration with the relevant experts from Pausch and our major customer.

Improved workflow for X-ray examinations

Most radiographers are familiar with equipment configurations which comprise ceiling-mounted X-ray tubes, a table, and a floor stand. This new apparatus features a ceiling-mounted U-arm (X-ray tubes and detector), which offers increased mobility and flexibility when carrying out routine tasks on a daily basis. The detector unit and the X-ray tubes are always centered to one another, which allows for faster positioning and, as a result, increased user-friendliness and improved patient comfort.

An all-in-one U-arm, part of the ceiling-mounted system, moves around the patient, making patient positioning easier and improving the workflow for the operator, the doctor carrying out the examination, or the radiographer. The patient can be X-rayed lying down, sitting in a wheelchair, or standing, for example, and does not have to be repositioned if X-rays need to be taken from two different sides. The system has been configured with three operator consoles in order to improve usability and workflow productivity. These consoles have been mounted at appropriate locations from an ergonomic point of view, so the number of times the radiographer has to change his position when capturing images is kept to a minimum. Patient data is transferred (by means of a DICOM worklist) from the hospital’s HIS/RIS to the system’s main operator console and to the two small operator consoles on the U-arm. Optional two-speed motor control enables positioning to be performed and fine adjustments to be made quickly. The collision-monitoring function, which is available in motor-controlled and manual modes, ensures that the patient and radiographer are both safe. Virtually all adjustments can be made via touch screens or a remote control.

 

Automation Valley: Pooling expertise to achieve joint success

The system was actually launched on the market and is already proving very successful in a number of renowned clinics. About half of the project time was spent on design and development, and the other half on integration and intensive testing. In order to meet the stringent requirements of standard IEC 60601-1-1, a risk analysis must be performed as the basis for deriving software requirements and an established, reliable V-model software development process is also required.

Interdisciplinary collaboration between mechanical, electronics, and software experts was used to great effect in this project. Key to this success was the experience that those involved had in executing complex mechatronics projects, as well as the high degree of overlap between the development processes established by the two companies.