www. med-eng.de/international
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www. med-eng.de/international
MED engineering INTERNATIONAL 2013 2013 w w w. m e d - e n g . d e/i n t e r n a t i o n a l 36 RoHS + REACH Mandatory: E10 in medical electronics 38 Titlestory: Small DC-motor with high-impact 52 CFR Polymers How to switch from metal to CFRP? EBVchips Semiconductors Developed with and for Our Customers! We already provide our customers with highly specific support in markets where intensive consultation is required, such as general lighting, automotive, consumer, renewable energies, FPGAs, medical technology and RF & wireless. Now we are going one step further and raising our services to the next level with a new and revolutionary service. Under the name EBVchips, we are now defining our own semiconductor products, which we are developing with and for our customers! These products will be manufactured by our suppliers, fulfilling special requirements of customers not covered by products already available. This makes EBV the first semiconductor specialist in the world to offer such a service. With EBVchips, we offer our customers competitive advantages, as they will now receive exactly the products and technologies they require for their individual applications. For further information, please contact your EBV partner on site or visit us online at www.ebv.com/chips. Distribution is today. Tomorrow is EBV! www.ebv.com Note of the Editor K eeping pace with the demographic shift was the subject at MED engineering’s forum at the electronica 2012 in Munich. During the discussion it became clear that the main challenge of the demographic shift in health care industry is certainly to close the growing gap between the increasing demand of medical aid and the decreasing number of medical staff as well as the decreasing number of tax and health insurance payers. This gap is not only raising ethical questions, e.g. ›who is going to care for the elder?‹ but also ›who will be able to pay health care costs in future‹? As a consequence cost pressure on everything and everybody in the health care industry will increase. Nearly every country is looking for ways to get health care cost under control. Even in the US where margins for medical products are much higher than elsewhere cost pressure will increase. Coping with the demographic shift Qseven™ MSC Q7-TI8168 Texas Instruments ARM CortexA8 with integrated DSP core Innovative combination of ARM Cortex-A8 RISC MPU with the TI C674x DSP core. A powerful module especially suited for vision, imaging, test and control. From a technical point of view MedTech industry faces this challenge by developing, for example, mobile devices that can be used by several physicians in a health care center (page 35). Further ideas are home care solutions and wearable technology. Both technologies are available but not in every day use. One reason is that they require a wireless IT infrastructure in order to connect the mobile devices with the patient’s electronic medical records. IT departments in hospitals or health care centers have to invest money but do not know whether these new technologies will be refunded. According to IDC Health Insights, there will be no savings without these investments. Other tendencies require investments too. Sustainability (page 36) of medical electronics for example or changes in regulation. Medical products might become more expensive in the end. The conclusion of the MED engineering forum therefore was that a supporting refunding policy is needed. Taking into account that the world’s population amounts to over 7 billion people today and is expected to count 7.7 billion in 2020, politicians should also start to think of a global demographic policy. Education and migration of young people from countries with high birth rates could be a way out of this spend-money-to-save-money-game. 3 Texas Instruments -ARM Cortex A8 CPU up to 1.2 GH -DSP Subsystem C674x up to 1.0 GHz 1 GB DDR3 SDRAM 2 GB Flash SSD soldered on board Gigabit Ethernet One PCI Express x1 port HDMI/DVI up to 1920x1080 @ 75 Hz resolution Single Channel LVDS 24 bit up to 1280x720 @ 60 Hz Dual Independent Display support Two SATA-II interfaces Six USB 2.0, HD Audio Linux support (WinCE and Android on request) V-11_2012-WOEI-6298 Erika Fuchs, Editor in Chief fuchs@hanser.de Qseven™ MSC Q7-TI8168 MSC Vertriebs GmbH Tel. +49 8165 906-122 boards@msc-ge.com www. msc-ge.com Contents Signal Transmission via Radio Waves In the operating theatre, medical devices with controls communicating via radio waves are increasingly common. This technology offers considerable advantages but demands high signal reliability. 12 Contact: Sophisticated Drive Systems for Tomorrow Editor-in-Chief Erika Fuchs Tel. +49 89 99830-626 Assistant Gabriele Wieser Tel. +49 89 99830-231 Advertisement Manager Martin Ricchiuti Tel. +49 89 99830-686 Publisher Carl Hanser Verlag GmbH & CO. KG, Kolbergerstraße 22, D-81679 München www.med-eng.de, E-Mail: med-eng@hanser.de, Fax +49 89 99830-126 Motor controllers are often based on user-specific circuits. However, complex applications can be developed more efficiently and economically on FPGA platforms. 33 Advisory Board Plastic Couplings are a Safe Bet Rainer Birkenbach, BrainLAB; Prof. Dr. Armin Bolz, Corscience; Kurt Eggmann, Weidmann Plastics; Prof. Dr.-Ing. Petra Friedrich, University, Kempten; Theodor Lutze, Aesculap; Prof. Dr. Peter Schaff, TÜV SÜD; Dr. Timo Schirmer GE Healthcare; Sigrid Uhlemann, DQS Medizinprodukte; Prof. Dr. Dr. Erich Wintermantel, University, Munich (TUM) MED engineering INTERNATIONAL 2013 Plastic couplings do not only guarantee a save connection at room temperature but also at high temperatures in autoclaves for example or at very low temperatures in cryotherapy. 54 4 © Carl Hanser Verlag, Munich MED Devices 16 Sensors in Medical Technology Modern sensors and measurement systems make medical devices more secure 18 New Products Telescopic Pillars for opthalmology and infant care 36 E10 in Electronic Medical Technology By June 2014 medical device manufacturers have to demonstrate the compliance of RoHS 2 and REACH MED Prostheses 38 Trusting the Next Step With the right leg prosthesis, being active can be part of dayto-day life again 20 Small, Fast, and Precise Neither magnetic fields nor humidity or vacuum influence piezoelectric drives 24 Finished Parts Within Ten Days Rapid injection moulded parts open up new perspectives in the world of regenerative medicine 26 New Products Quad Lock connectors enhance diagnostic functionality 28 Process Safety in Laboratories Sensors make sure that processes are reliable, precise and efficient 41 New Products Long-lasting hygiene with antimicrobial cables 46 New Products Micro-Spaghetti Tubing with thin and stable walls MED Informatics 42 Developing Safety-Critical Software If development of the software is model-based, it helps developers of safety-critical devices to meet legal requirements MED Materials 48 The Way to Perfect Catheters Whether multi-lumen catheters will be a success depends on a precise specifications 52 Surgical CFRP Instruments: More than Radiolucent To switch from metal to CFRP requires an experienced engineering and manufacturing partner 51 New Products Electronically variable optical diffusers MED Electronics CONFOCAL TECHNOLOGY FOR MEDICAL ENGINEERING Nano-resolution for displacement and thickness measurement 30 ARM and DSP Ensure Rapid Imaging Digital signal processors improve image processing and quality in ultrasonic and X-ray applications 35 Measuring the Speed of Blood Flow in Real Time With a Micro-ATX board digital Doppler and duplex sonography come in one device NEW Fast measurement on changing surfaces For high precision measurements Service 03 06 10 58 Note from the Editor MedTech News MedTech Events Masthead/Index World’s fastest controller (70kHz xenon / 10kHz LED) EtherCAT, Ethernet, RS422 and analogue Smallest spots for tiny objects High resolution and independent of the material surface e.g. Diameter measurement of stent wire Titlepage Advertising Trusting the next step The maxon motors built into the prosthetic leg ensure smooth operation of the hydraulic system of the C-Leg. This allows the user to carefreely play soccer and climb stairs. (Photo: Otto Bock) Whereever maximum power is needed in the smallest places, maxon motor’s precision motors are employed. We serve a variety of specialized markets within the medical industry, such as diagnostics, therapy, prosthetics and laboratory technology. maxon motor ag Brünigstrasse 220 CH-6072 Sachseln Phone +41 41 666 15 00 www.maxonmotor.com www.micro-epsilon.com 5 MICRO-EPSILON | 94496 Ortenburg / Germany MED engineering INTERNATIONAL 2013 Tel. +49 85 42/168-0 | info@micro-epsilon.com The Center of Attention was the central meeting point at the first World Medtech Forum in Lucerne Successful Start Next World Medtec Forum in the new trade fair center. According to the organizers the first World Medtech Forum (WMTF), held from September 25 to 27 in Lucerne (Switzerland), has been a success. It provided a mix of international suppliers, latest developments in Swiss medtech research and inputs from the medical technology sector. Around 3200 people, 20 percent of whom had travelled from abroad, attended the WMTF. The international character of the forum was further underscored by the visit of a delegation of Russian healthcare specialists and the presentation on Bavarian medtech companies organized by the German-Swiss Chamber of Commerce. The congress attracted some 300 attendees. The high standard of the lec- tures and presentations given by the 150 top-class medtech experts in the various WMTF venues met with universal acclaim. Exhibitors, visitors and speakers grasped the opportunity to network and share experience with renowned experts, and to discuss current issues in the workshops – even doing so at international level. Peter Biedermann, Managing Director of the Swiss Medical Cluster expressed his satisfaction: »We wanted a quality event, and that is what we got. It has been a successful start and timing was ideal. The medical technology sector has taken this chance to spend four days discussing the opportunities and challenges facing it.« The central meeting point at the trade fair was the Center of Attention – a platform for informal and interdisciplinary exchange between research institutes at hospitals, universities, universities of applied science and the medical technology industry. The 50 lectures in the auditorium integrated into the center were well attended. The WMTF’s partners and the medtech industry are unequivocally in favor of repeating the WMTF in 2013. So the next WMTF will be held from September 17 to 19, 2013 at the Lucerne trade fair center. The new trade fair site will have been completed by this time and will be of the highest standard. The compact, modern infrastructure is exactly in line with the WMTF’s quality strategy, which is geared to moderate growth and maximum exhibition quality. The current successful formula of congress, trade fair and meetings will also be retained. www.medtech-forum.ch Photo: Erika Fuchs; CHV MedTech News Watlow Receives Löhn Award Steinbeis Foundation awarded transfer of highly dynamic variothermal technology MED engineering INTERNATIONAL 2013 The Steinbeis Foundation has awarded its 2011 Löhn Award to Watlow, the Steinbeis Center for Plastics and Sony DADC jection molding process. This solution has been successful in the commercial environment by Sony DADC, incorporating it into large-scale production. This collaborative project started in 2009, and allowed the sharing of specialist knowledge in commercial microfluidic chip production, thermal systems and the properties of plastic areas between Sony DADC, Watlow and Steinbeis respectively. www.watlow.com 6 © Carl Hanser Verlag, Munich Photo: Uli Regenscheit (Stuttgart) The Löhn Award has been awarded annually since 2004, in honor of Prof. Dr. h. c. mult. Johann Löhn who was instrumental in the technology transfer aspect of the Steinbeis Company. This year the award went to Watlow, the Steinbeis Center for Plastics and to Sony DADC. In a joint transfer project between the three, the high dynamic variothermal (HDV) technology was developed and introduced and allows producing micro structured components in medical technology. In order to make this technology possible, Watlow developed a thermally sprayed electrical heating system for highly dynamic variothermal temperature modules as well as the necessary control system. The potential of lab-on-chip technology in medical science is enormous, but the price of the chips is holding back some research. The exacting standards of the equipment cause production techniques to be complex and costly, with the single-use nature of the device further adding to this. Cost-effective mass manufacturing of these components is central to seeing the potential of this technology maximized by a variety of different areas within the bioscience and pharmaceutical industries. Applying the technology developed by Watlow, a company designing and manufacturing thermal solutions, and the Steinbeis Transfer Centre for Plastics, Sony DADC BioSciences have refined the manufacturing process for plastic chips, using injection molding, to great effect. Taking advantage of Watlow’s thermal expertise, they were able to meet the standards expected of the chip’s performance during the in- Photo: Bayer HeathCare Positioning Systems FOR MICROSCOPY Bayer HealthCare acquires Radimetrics Leadership in medical information technology Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion in 2011, is a supplier of healthcare and medical products and is based in Leverkusen, Germany. The company announced End of November 2012 that it has entered into a definitive acquisition agreement with the principals of the privately-held Radimetrics Incorporation, to purchase all shares of the company. Toronto-based Radimetrics develops healthcare software and has introduced software to accurately measure a patient’s radiation exposure over the course of multiple imaging procedures. The software, eXposure, is also a very powerful quality assurance and improvement platform that includes the ability to define and manage scanner protocols. Financial details on the agreement were not disclosed. »This is a strategic acquisition as Bayer moves its Radiology & Interventional business forward to be the end-to-end provider of products, solutions and service for the radiology customer,« said Alan Main, Head of Bayer HealthCare’s Medical Care division. Radimetrics employees in Toronto and Scotland will become employees of the Bayer group, expanding the company’s existing informatics group in the Radiology & Interventionals organization. Founded in 2009, Radimetrics’ flagship product, eXposure, integrates with existing imaging and patient information technology storage systems (i.e. PACS/RIS ) to provide a single system for tracking patient radiation exposure across imaging modalities. The software has been used in many commercial hospital groups and other medical delivery organizations in North America and a growing number in Europe. According to Alan Main, »Bayer Healthcare’s Radiology & Interventional is well positioned as a leader in the industry to accelerate broad market adoption of eXposure to new customers who are looking for ways to better leverage technology and improve radiation dose monitoring accuracy. The combined strengths of our informatics platforms will drive future innovative customer solutions.« Gregory Couch, President and founder of Radimetrics, said: »Today’s agreement is a new chapter in a great alliance which began earlier this year. Radimetrics has been committed to developing innovative software that focuses on patient’s safety, quality and productivity in medical imaging. We feel that Bayer Radiology & Interventional is well positioned to continue this commitment and I’m excited to join the organization and work to make this happen.« www.healthcare.bayer.com P-545 – Dynamic Motion in 3 Axes Travel ranges to 500 μm Resolution in the nanometer range Response time in the range of a few milliseconds M-687 – Low-Profile, Precision XY Stage Travel ranges to 135 mm Minimum incremental motion up to 0.1 μm, highly stable Velocity to 120 mm/s PIFOC® – Scans and Positions Objectives Travel ranges to 1 mm Resolution in the nanometer range Minimum settling time Positioning systems from PI are particularly suited for the most challenging applications in microscopy, life science, biotechnology or medical technology. They offer subnanometer resolution, large travel ranges and they are extremely fast. For more information, contact us: info@pi.ws · www.pi.ws Physik Instrumente (PI) GmbH & Co. KG · Tel. +49 (721) 4846-0 PIEZO NANO PI-MICROSCOPY pi_120973_kombi_m2_85x250_en.indd 1 7 POSITIONING 26.11.12 12:20 MED engineering INTERNATIONAL 2013 Medica and Compamed 2012 More economic solutions and strong focus on ergonomics 130 600 visitors came to Dusseldorf, Germany in order to attend the medical trade fair MEDICA and about 16 000 visited the supplier’s exhibition COMPAMED which both took place from 14th to 16/17th November 2012. »MEDICA is a true reflection of the market. Tight health care system budgets worldwide prompt more and more commercial departments and sickness funds to intervene in investment decisions,« explains Joachim Schäfer, Managing Director at Messe Dusseldorf. Due to the cost pressure characteristic of nearly all predominantly state-financed health care systems not only high-end technology solutions are in demand. Users also ask for robust, affordable products and systems for the widest possible spectrum of use. An example are medical imaging systems such as ultrasound. Vendors have started to equip medium-priced equipment with advanced imaging technologies and ultrasound probes that were previously only available in the up-market segment of devices. Additionally, updates make for new operating functionalities without having to exchange the whole system for a new device. One focal theme was Health IT. There is rising demand for compact solutions for a better networking of health care players, such as for the data transfer amongst physicians and between physician and patient. Tablet PCs or smartphones are therefore on the advance in surgeries and hos- pitals, as are the so called ›Apps‹. One overview of useful health Apps was provided by the ›AppCircus‹ of the company dotopen at the IT FORUM in Hall 15. If more and more digital data is available the question of safe data storage arises, especially when talking about data storage by Cloud computing. Therefore the question of which medical data is permitted to be stored on external processors, which legal aspects need to be taken into consideration and, above all, which medical benefits can be derived from storing data in the Cloud received plenty of attention in the lectures and discussions at the IT FORUM. Held in parallel with MEDICA was COMPAMED, the trade fair for suppliers to medical device manufacturers with 645 exhibitors from 34 nations. In the exhibition halls 8a and 8b over 16 000 visitors came to convince themselves of how closely the upstream suppliers cooperate with medical device manufacturers in terms of product development today. Suppliers are increasingly focused on ergonomics. Be it ultrasonic equipment, OR workstations or patient monitors – despite continuous performance improvements in medical devices their handling is getting constantly easier. This is made possible by modern touch-screen GUIs and intuitive menus as customized by some exhibitors. The trend towards miniaturisation, ever more compact and yet more complex systems, e.g. tiniest components for so-called lapon-a-chip applications, was the theme at the booth of IVAM – Association for Microtechnology. Current supply market trends were also addressed at the two technical forums integrated into COMPAMED, which specifically targeted experts for manufacturing processes and product development. Photo by Messe Düsseldorf MedTech News www.medica-tradefair.com www.compamed-tradefair.com Low-cost Camera cleaning procedures after every useage are time-consuming. This problem might be solved by the microcamera that the Fraunhofer Institute for Reliability and Microintegration (IZM) in Berlin, Germany has developed with Awaiba and the support of the Fraunhofer Institute for Applied Optics and Precision Engineering IOF. Because of a new manufacturing process microcameras can be produced at such a low price that doctors can dispose the endoscopes after the first usage. Digital camera systems consist of a lens and a sensor that transforms the image into electrical signals. Electrical contacts on the sensor allow access to these signals and to the information of the image. Due to the way they are manufactured, these contacts are located between the sensor and the lens. The sensors are manufactured simultaneously in large numbers, like computer chips. About 28 000 image sensors fit onto one wafer and until recently, each was sawed out, wired and mounted on the lens. The researchers have streamlined MED engineering INTERNATIONAL 2013 this process by developing a new way to access the electrical contacts. Now, the wiring process is faster and the camera system smaller. Contacts of each individual image sensor are no longer reached via the side but, simultaneously, with all sensors via their reverse side while they are still connected as a wafer. The lenses no longer have to be mounted. Instead, they can be connected with the image sensor wafers as lens wafers. Afterwards the stack of wafers is sawed apart into individual microcameras. The camera supplies razor-sharp pictures even in thin endoscopes and has a size of 1.0 x 1.0 x 1.0 millimeters. www.fraunhofer.de 8 © Carl Hanser Verlag, Munich Photo: Fraunhofer IZM Disposable endoscopes now affordable. Endoscopes are expensive and INTERNATIONAL TRADE SHOW HIGH-PRECISION LEADER WATCHMAKING AND JEWELLERY - MICROTECHNOLOGIES – MEDTECH WWW.EPHJ.CH MedTech Calender 2013 MedTech Events Arab Health International exhibition and conference www.arabhealthonline. com January 28 – 31, 2013 Dubai, United Arab Emirates MEDTEC UK European medical device manufacturing industry, trade fair www.medtecukshow. com May 1 – 2, 2013 London, UK LASER World of PHOTONICS Trade fair for optical technologies www.world-ofphotonics.net May 13 – 16, 2013 Munich, Germany CISOP Rapid.Tech International interdisciplinary congress and fair about dental www.ciosp.com.br Jan. 31 – Feb. 3, 2013 Sao Paulo, Brazil Trade fair and users conference for rapid technologies www.rapidtech.de May 14 – 15, 2013 Erfurt, Germany IS&T/SPIE Electronic Imaging International forum for digital imaging systems www.spie.org/x16218.xml February 3 – 7, 2013 San Francisco, USA SPIE Medical Imaging CMEF Spring 2013 MEDTEC France International fair about medical equipment www.cmef.com.cn/en/ index.html April 17 – 20, 2013 Shenzhen, China European medical device manufacturing industry, trade fair www.medtecfrance.com May 15 – 16, 2013 Lyon, France Medica World forum for medicine www.medicatradefair.com November 20 – 23, 2013 Dusseldorf, Germany Compamed International trade fair – high tech solutions for medical technology www.compamedtradefair.com November 20 – 22, 2013 Dusseldorf, Germany Med-e-tel Orthotec Europe International forum for medical imaging www.spie.org/medicalimaging.xml February 9 – 14, 2013 Florida, USA Intern. eHealth, telemedicine and health ICT forum for education, networking and business www.medetel.eu April 10 – 12, 2013 Luxembourg, Luxembourg European orthopaedic design and manufacturing conference and exhibition www.orthoteceu.com October 23 – 24, 2013 Zurich, Switzerland MD&M West Implants Lyon International trade fair for manufacturers of medical devices www.canontradeshows. com/expo/west13 February, 12 – 14, 2013 Anaheim, USA Intern. conference und exibition for orthopaedic implants and biomaterial www.implants-event. com/2013-uk-index.php April 3 – 4, 2013 Lyon, France China Med International exhibition for medical instruments and equipment www.chinamed.net.cn/en March 28 – 30, 2013 Beijing, China MEDTEC Europe European medical device manufacturing industry, trade fair www.medteceurope.com February, 26 – 28, 2013 Stuttgart, Germany MED engineering INTERNATIONAL 2013 Embedded World International exhibition and conference www.embeddedworld.de/en February, 26 – 28, 2013 Nuremberg, Germany SMT Swiss Medical Technologies Meetingplace for Medtech www.ephj.ch/en June 11 – 14, 2013 Geneva, Switzerland MD&M East International trade fair for manufacturers of medical devices www.canontradeshows. com/expo/east12/index. html June 18 – 20, 2013 Philadelphia, USA AdvaMed Conference International MedTech conference www.advamed2012.com September 23 – 25, 2013 Washington, USA 10 K 2013 International trade fair for plastics and rubber www.k-online.de October 16 – 23, 2013 Dusseldorf, Germany MEDTEC China Trade fair for Medical device manufacturing industry www.medtecchina.com September 25 – 26, 2013 Shanghai, China World Medtech Forum Congress and trade fair for manufacturers of medical technology www.medtech-forum.ch September 17 – 19, 2013 Lucerne, Switzerland © Carl Hanser Verlag, Munich MedTech News Partnership in OR Integration Solutions Maquet and Richard Wolf announced sales cooperation Maquet and Richard Wolf have announced a non-exclusive sales cooperation on a regional level. By joining forces, both companies will be in the unique position to offer complete, efficient and high-quality OR integration solutions for endoscopy. Both companies have significant market share in their respective fields of expertise. Maquet offers a full range of products for the OR from tables, lights and ceiling supply units to intraoperative media management. Richard Wolf is one of the world’s leading manufacturers of endoscopic equipment, providing best-in-class integrated solutions for minimally invasive surgery in all major surgical disciplines. » The integration of core.control and Tegris is an opportunity to provide a scalable and comprehensive solution.« Timo Haller, Head of OR integration at Richard Wolf You need to design a reliable product? Our Board-to-Board and Board-to-FPC connector portfolio supports you with ◗ Compact size A modern OR is a highly technified environment consisting of many complex devices that must seamlessly and transparently work together to allow the OR staff to perform safe, high-quality surgery. Furthermore ORs are part of the larger hospital IT landscape exchanging data in and out of hospital networks such as clinic information and picture archiving systems. Managing these devices and networks as well as dealing with environmental control and multi-modality video and image distribution is a major challenge for the OR personnel. This announcement introduces the integration of Richard Wolf’s endoscopy tower, including the device control solution core.control, into Maquet’s TEGRIS system for OR integration. This combined solution will improve intraoperative efficiency by streamlining device control and overall OR management thus accelerating procedures and making them safer by allowing the OR staff to concentrate on their primary task. According to Bastian Diebald, head of Maquet’s OR Integration Global Sales: »As a provider of OR Integration systems, we view our role in the operating room efficiency improvement by uniting video routing, recording and transmission, data management and device control – independent of the manufacturer. This cooperation provides an opportunity for our two companies to combine forces«. »The seamless integration of Richard Wolf’s core.control and Maquet’s Tegris offers Richard Wolf the opportunity to provide a scalable and comprehensive solution bearing the quality and reliability of two world class companies«, said Timo Haller, head of OR Integration at Richard Wolf. www.maquet.com / www.richard-wolf.com 11 ◗ Wide product range ◗ High contact reliability ◗ Cost-efficient subsequent processing With a contact pitch of 0.2mm to 0.8mm and mating heights of 0.6mm to 14mm with various numbers of contacts, you are sure to find the right product. For more information, please go to www.panasonic-electric-works.com/connectors Panasonic Electric Works Europe AG 4ELs&AX info.peweu@eu.panasonic.com www.panasonic-electric-works.com Medical Devices Wireless Controls In the operating theatre, medical devices with controls communicating via radio waves are increasingly common. This technology offers considerable advantages but demands high signal reliability. Signal Transmission via Radio Waves 1 Hygienic, ergonomic, versatile: wireless controls in operating theatres, doctors’ surgeries and hospitals are advantageous for multiple reasons W hich features should controls for medical equipment have? They need to be ergonomically comfortable and intuitive to use – not always easy to realize in the light of increasingly complex functions. They must be extremely reliable and failure-safe. In addition, their design has to meet hygiene requirements. And they should also offer the surgeon or surgical staff a free choice of posture while working. With all these requirements in mind, the utilization of foot controls has proved a good choice for many medical devices and across very different medical disciplines (Figure 1). This is by no means MED engineering INTERNATIONAL 2013 a new development, but one which has taken place over decades. What is new, however, is that these foot controls are increasingly wireless. There are good reasons for this, based on the Wireless transmission above mentioned requirehas to be reliable ments. A wireless foot control can be positioned far more freely than a switching device with power and signal transmission cables, and it also adheres far more closely to the ›Hygienic Design‹ guidelines. In addition, a cable which could turn out to be a tripping hazard is removed from the 12 © Carl Hanser Verlag, Munich Contact steute Schaltgeräte GmbH & Co KG D-32584 Löhne/Germany Phone +49 (0)5731 7450 Fax +49 (0)5731 745-200 All photos: steute Schaltgeräte GmbH & Co. KG 2 The modular design of steute’s wireless technology – here the Bluetooth module inside a foot control – permits simple integration in control systems www.steute.com floor. Uniting foot controls and radio technology is therefore an elegant solution for the operating theatre – but one which is not so easy to realize. This becomes clear when one takes a look at the demands made on signal transmission by the sensitive application field of medical equipment. Most important of all, the system must be free from interference and transmission has to be reliable: it must not be allowed to happen that a command given by the surgeon does not reach the device. This is all the more difficult to guarantee because in hospitals there are numerous potential sources of interference, such as Wi-Fi networks. The crucial keyword here is coexistence ( freedom from mutual interference with other wireless networks). This means that the radio protocol has to check and confirm correct reception. In addition, it is a good idea to allow for redundancy (in the shape of multiple transmission) or other safety functions in order not only to detect a fault, but to guarantee that signal transmission will still go ahead correctly and rapidly. Further requirements for wireless communication Wireless protocol in the operating theatre involve, amongst other things, connection for worldwide use time (as fast as possible), power consumption (as low as possible in order to achieve a long battery life) and a wireless protocol which can be used worldwide. Last but not least, cost (as low as possible) also plays a role. Diverse approaches have already been pursued in the past. As much as fifteen years ago, developers in the steute business field Meditec had first wireless switching devices ready for the market. One of the elements used was infra-red data transmission. However, this type of wireless signal transmission is only suitable for devices which are not safety-related, for example imaging devices, because the infrared signals are only unidirectional and not Company Profile Micro-optical precision sensors! 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Headquarter in Germany Prof.-Messerschmitt-Str. 1 85579 Neubiberg Phone headquarter: +49 89 666371-0 info@stmsensors.de www.stmsensors.com Our product range: • Micro-optical LEDs, photo diodes and laser modules • COMPACT optical sensors for position detection • MICROmote® - The superior alternative to fiber optics • Optical sensors for use in extreme environments • Optical light band sensors for web guide control • Fork and frame sensors for counting applications • Precision liquid level sensors • Customized Solutions Applications: • Assembly and Handling Automation • Processing • Medical and analytical laboratory equipment • Measurement technology www.stm.com • Special machine building Sales Office in U.S.A. STM Sensors Inc. P.O. Box 1888 Round Rock TX 78618 Phone: +1 419 8410135 Fax: +1 419 7542285 sales@stmsensors.com www.stmsensors.com 13 MED engineering INTERNATIONAL 2013 Medical Devices Wireless Controls 4 For phacoemulsification steute has developed both customized foot controls and a control which is suitable for all manufacturers, transmitting signals either via a cable or radio waves Fast bidirectional transmission sufficiently interference-free either. LCD displays, for example, can impair the quality of signal transmission. When the Bluetooth standard was introduced worldwide in the year 2000, steute enhanced it for medical equipment. And with success: since then, numerous manufacturers of medical devices have used steute wireless foot controls incorporating this technology (Figure 2). Typical application fields include ophthalmology and surgical microscopes. Some application fields make demands which cannot be met using Bluetooth, however. The power consumption of wireless units and the wake up time when activating a control unit in standby mode are both problematic, for example. For these reasons steute has developed its own tried-and-tested wireless protocol, marketed under the name SW 2.4 MED. The protocol is based on the globally accessible 2.4 GHz waveband. The communication protocol is split between 32 channels and navigates between these channels using a ›frequency hopping‹ procedure. In this way sources of interference are avoided. In addition, the SW 2.4 MED wireless technology has at its disposal various other MED engineering INTERNATIONAL 2013 5 Even complex functions can be managed using the SW 2.4 MED wireless protocol. Pictured: a new control system for surgical microscopes procedures for the automatic detection and correction of transmission errors. And since one transmitter and one receiver unit are always mutually and strictly assigned via a special ›pairing‹ procedure, the user can simultaneously operate all manner of devices communicating via SW 2.4 MED. Signals are transmitted bidirectioSleep mode nally within 20 milliseconds. Four reduces power protocols are transmitted at diffeconsumption rent frequencies, each taking 5 ms. This meets the requirement of a short response time. Bidirectional transmission means that signals are acknowledged and that errors can be detected directly. In this case the transmitter and receiver modules automatically hop to a different channel. The channel with interference is permanently faded out. At a maximum of 25 mA, the power consumption of this wireless communication is as much as 60 percent lower than with other radio standards. The steute engineers have also managed to achieve a further energy-saving effect. Since medical devices are seldom in operation for hours on end, most of the power is usually consumed during periods of inac- 3 With handheld controls, the very low power consumption of the SW 2.4 MED radio standard proves especially advantageous. It creates the prerequisite for using a small and light battery while achieving a long battery life 14 © Carl Hanser Verlag, Munich MG110025 www.med-eng.de tivity, in which only stand-by signals are sent and the device waits to be actuated. This is inefficient. The sleep mode was therefore developed as an energy-saving function during such waiting periods. In this mode the wireless system reduces its power requirement to just 6 μA. As soon as the Wireless control user activates a switching function, the system is reactivated and the of a surgical wireless data connection restored mircroscope in under 200 msec. This usually goes unnoticed by the user, who nevertheless profits from a considerably longer battery life. Due to the low power consumption, a very long battery life can be achieved with alkaline batteries. A further option is a lithium-ion battery pack which can be recharged using a battery charger. This rechargeable unit contains a battery management feature which continually records, monitors and transmits the key parameters such as battery voltage, remaining capacity, temperature and the number of charge cycles. Microelectronics and the availability of modern sensor technology have enabled interesting extra functions to be realized, further increasing the reliability of this wireless technology. One example: sensors permanently monitor the position of the foot control. If the control unit is lifted off the floor, all functions are automatically blocked and a warning signal is generated. Since steute Meditec has designed its wireless technology as a compact and modular system, with nearly all foot controls in the stan- @ dard catalogue range the user has the choice between a system with a cable or a wireless system. That is true not only for the foot controls, but also for the new generation of hand controls (Figure 3). Thanks to the low power requirement of the SW 2.4 MED radio technology, a long battery life can be achieved with a small and light battery. This also increases the user’s comfort, especially with the hand-held devices. Our foot control for phacoemulsification demonstrates how even very complex functions, including analogue signals, can be managed by SW 2.4 MED (Figure 4). For this form of eye surgery to treat cataracts, steute has developed a foot control for ophthalmologists incorporating a mobile foot rest. Moving the foot guides the breakdown and extraction of the human eye lens. Additional push-buttons regulate or activate extra functions, such as the intensity of the cutting tool or the rinsing of the eye. steute has also developed a complex control for a surgical microscope which transmits signals using radio technology (Figure 5). Guido Becker is Product Manager Meditec at steute Schaltgeräte in Löhne, Germany. meditec@steute.com Company Profile apra-plast KunststoffgehäuseSysteme GmbH Germany Hamsterweg 9 54550 Daun-Pützborn Tel. +49 6592 9502-0 Fax +49 6592 9502-10 vertrieb@apra-plast.de www.appra-plast.de The apra-plast Kunststoffgehäuse-Systeme GmbH is a specialist for the production of individual plastic parts and enclosures for low and middle quantities (1 – approx. 2000 pieces). The combination of milling and bending enables apra-plast to offer customized enclosures and complex solutions. In cooperation with the apranorm department radaplast, that also belongs to apra group, there can be realized quantities up to 100.000 pieces in our in-house tool making and injection moulding from the first drawing or model to the whole series. radiuses in a solid design and with optical correctness. This technique brings many advantages compared to usual milling / bending technique such as better quality and cost-effective production of small batches as well as prototypes. The new circular bending technique enables apra-plast for the first time to realize also small Another big advantage is the material mix in the apra group: electronic enclosures that can be produced in combination of the different materials sheet steel, stainless steel, aluminium and plastics. The apra group uses all advantages of the different materials and manufacturing techniques in an optimal way. True to our guideline apra produces “the perfect shell for valuable electronics” for more than 40 www.apra-plast.de years. 15 Furthermore there are almost no limits in customer´s requirements regarding design: In addition to different material colours and thicknesses the enclosures can be customized also by using silk screen, front foils, membrane keypads or integrated LED. MED engineering INTERNATIONAL 2013 Medical Devices Sensor Systems Modern sensors and measurement systems are helping to make medical interventions more secure, automate research, and to design more ergonomic medical devices. Sensors in Medical Technology housing guard ring capacitor field lines measuring spot L et's start with capacitive displacement sensors. During capacitive measurements, the sensor and target act as electrodes for the electrical capacitor (Figure 1). If a constant alternating current is flowing through, the amplitude of the alternating voltage is proportional to the distance between sensor and target. Capacitive sensors are very stable and provide nanome- MED engineering INTERNATIONAL 2013 ter-accuracies and resolution, which is why these sensors are used in high precision applications. For example, they are used in surgical procedures, where a perfect line of vision to the operating table is required. Here, the surgeon is often supported by a surgiFine positioning cal microscope. The microscope optics are attached to the long arms of a stand. The pivot joints require continuous adjustments to keep the microscope area of vision stable for the surgeon. This is where the capaNCDT capacitive sensor is used. The system measures the distance to the reference area, which reflects the arm movement in the pivot joint. If 16 © Carl Hanser Verlag, Munich All photos and figures : MICRO-EPSILON MESSTECHNIK GmbH & Co. KG 1 Measuring principle of capacitive sensors: If a constant alternating current is flowing through, the amplitude of the alternating voltage is proportional to the distance between sensor and target MD110023 www.med-eng.de @ 2 Confocal chromatic sensor scanning the fill level of microtiters the reference displacement is too large, the control mechanism will move the arm back to its original position. Key benefits of this solution include its compact design and easy integration of the system into an existing design. It also provides the surgeon with a clear picture throughout the entire procedure. even if the meniscus of a liquid is large. confocalDT sensors can be used for measurements on any liquid. Miniature sensors with a diameter of four millimeters or more can be arranged in rows to scan the entire width of the microtiter plate. wireSENSOR draw-wire sensors ensure optimum patient positioning of operating tables. The sensor wire is wound around the drum (Figure 3) on one side and attached to the moving object on the other side. An encoder translates the movement created by the extension of the wire into an electronic signal. An operating table is modular in design and provides many adjustment options for the optimum positioning of the patient during an operation: table height, horizontal position and multiple angle features, e.g. for head, torso and legs. Measuring technology is required to read the positions of the various adjustable elements. Due to their compact footprint, high precision and long service life, draw-wire sensors from Micro-Epsilon are the ideal choice. Typically, up to five draw-wire sensors are mounted to an operating table. As well as standard sensors with steel wires, there is also a choice of synthetic wire versions or sensors with plastic connectors that prevent any 3 Internal structure of a draw-wire sensor: Beside sensors with steel wires, there is also a interference with X-ray or MRI scans. In certain cases, sensors even make it possible to switch from manual to automated procedures, for example, in medical laboratories. In this scenario active agents are manually filled into microtiter containers for batch testing. It is essential, but also challenging, Filling level to measure each measurement agent precisely. During automated filling, the fill volume is controlled automatically. However, small batches that are often used in medicine are pipetted manually. Typically, random samples are measured, but this is not sufficient for 100 percent quality control. Confocal displacement measurement is an excellent solution for such applications. During confocal chromatic measurements lenses are used to separate white choice of synthetic wire versions or sensors light into different spectra, which is then fowith plastic connectors that prevent any interIn addition to draw-wire sensors, cused perpendicular to the object (Figure 2). ference with X-ray or MRI scans capacitive and confocal measuring A spectrometer is used to transmit the resystems for displacement and disflected light to the CCD array: each position in tance measurements, Micro-Epsilon offers optical micrometers, the CCD array now corresponds to one wavelength, i.e. the distemperature and colour sensors, laser sensors, and magneto-intance between target and sensor. This technology facilitates meaductive measurement systems for medical technology, pharmasurements to nanometer ceuticals and biotech industries. resolutions. The confocalDT sensors successively scan Contact the microtiters in the plate, MICRO-EPSILON MESSTECHNIK and the system measures GmbH & Co. KG the distance from sensor to D-94496 Ortenburg/Germany liquid to micrometer accuPhone +49 (0)8542 168-471 Dipl.-Phys. Johann Salzberger racies. Standard confocal is Managing Director Marketing and Sales at Fax +49 (0)8542 168-90 sensors can be tilted which Micro-Epsilon Messtechnik in Ortenburg, Germany. www.micro-epsilon.de Johann.Salzberger@micro-epsilon.de means they work reliably 17 MED engineering INTERNATIONAL 2013 New Products Multiturn Encoder The SHTC1 humidity and temperature sensor is specifically designed for mobile devices where size is always a critical factor. During the development of the high performance humidity and temperature sensor, Sensirion has rigorously followed the maxim ›smaller is better‹. According to the company, it is world’s smallest sensor in its class, measuring 2 x 2 x 0.8 mm. The sensor is based on the CMOSens Technology, which allows the sensor and the signal processing electronics to be combined on a single silicon chip. This reduces the size of the device. Production is targeted at high volume to Small Sensors are Better allow low unit prices to be achieved by economy of scale. The supply voltage of 1.8 V is in line with the designers’ needs. The specifications of the new sensor show that the size, power consumption and price reductions do not have any impact on performance. It measures relative humidity over a range of 0 to 100 percent RH with a typical accuracy of ±3 percent RH. The temperature measuring range is –30 to +100 °C with a typical accuracy of ± 0.3 °C. The sensor is calibrated, has a digital I2C interface, and is suitable for reflow soldering. This makes it compatible with standard industrial mass production processes for electronic modules. To ensure effective integration of the sensor in complex applications. Sensirion draws on its long experience with sensor products deployed in the millions and supports customers with corresponding application expertise. www.sensirion.com Gear and battery free operation. PEWATRON distributes ELTRA’s multiturn encoder EAM36 with SSI interface. Wherever drives need compact and cost effective feedback systems, or in applications demanding particularly compact size, or customer specific applications fields, the EAM36 series with a size of only 36 mm of OD and 43 mm of length represents an excellent choice. It is robust, provides a high resolution of 51 bit in total, high reliability and a gear and battery free operation. What makes the EAM36 encoder series special is the unique technology used to count the number of rotations that the device does. The solution that the Eltra designers developed is based on the ›Wiegand effect‹. The key feature of the EAM 36multi-turn encoders is that the turn counter mechanism is self-powered. The encoder shaft rotation generates enough electrical energy – independently from the rotating speed – to trigger the turn counter and to save the event in a non-volatile random-access memory (FeRAM). Eliminating the traditional mechanical gear or electronic counter with battery ensures a higher reliability and a maintenance free solution. The magnetic technology is the key contributor for ruggedness and compact size of the EAM36 complementing the well known ELTRA's multi-turn optical series (EAM58, EAM63). www.pewatron.com with a detachable cord that is compatible with nearly any voltage, frequency and plug type worldwide. Their mounting plate-backward compatibility with SKF Telescopic pillars series TXG, cable-through with inlet and outlet mains socket accessories and low 1 W standby power expand product design and differentiation possibilities. The products come with a variety of choices: selection of the position of the outer tube, motor, connector, and power in. These choices offer the customer a tailor-made solution to improve both operator accessibility and patient comfort. The telescopic pillars are available from different SKF manufacturing facilities worldwide providing support to OEM’s regardless their market location. www.skf.com Telescopic Pillars Solutions for ophtalmology and infant care SKF announces the telescopic pillars for ophthalmic equipment and infant care series CPMA and CPMB. It is a lifting solution for a range of medical equipment like ophthalmic chairs, ophthalmic tables and incubators that provides higher flexibility for the integration into OEM’s design. The CPMA series that consists of telescopic pillar for ophthalmic equipment and the CPMB Telescopic pillar for infant care offer a complete IEC/UL 60601.1 3rd edition compliant solution. Features include a soft start/stop motion that allows silent lifting, a short retracted length and increased stroke length for greater MED engineering INTERNATIONAL 2013 accessibility as well as a wide degree of design flexibility overall. The reduction of noise and vibration provide greater comfort for both patients and operators. Both pillars are compact, two-section units with the ability to mix and match several performance features, such as allowing variable placement of the motor and inner and outer tubes. They also offer a loadcarrying capacity of up to 2000 N and up to 250 Nm as well as a built-in universal power supply 18 © Carl Hanser Verlag, Munich Intelligent Actuator No control box necessary Limited space can turn the integration of electrical adjustment systems into medical applications a considerable challenge. With two new linear actuators, LA43 IC (8,000 N) and LA44 IC (10,000 N or 12,000 N), LINAK offers an answer. The IC actuators are based on the OpenBus platform and with a printed cir- The Precision Fluidics Division of Parker Hannifin is introducing the PACE Hf high flow miniature proportional valve targeted at respiratory and anesthesia applications. It utilizes a piezo actuator to enable controllable flow of up to 540 slpm in a very compact and Miniature Control Valve energy efficient package. The valve can control flow from 0,5 to 540 slpm with a 0 to 10 V DC analog input controllable in 0,001 V DC increments. This enables precise flow control throughout the full performance range of the valve. The proportional valve has an integrated sensor port that facilitates simple, closed loop feedback giving the customer precise pressure or flow control. Typical applications will consume less than 1 W, enabling longer battery life or the ability to use a smaller battery to save size and weight. The typical hysteresis amounts to < 4 percent (full scale) an the response time to less than 20 msec (full cycle). www.parker.com cuit board inside there is no need for mounting a control box. High speed under maximum load and a low noise level offer a high degree of comfort. The actuators can be connected directly to a foot switch or hand control and a second linear actuator. If necessary power is supplied by the SMPS30, a switch mode power supply with an input-range from 100 to 240 V AC. The 300 W powerful SMPS ensures maximum use of actuator capacity and is an eco-friendly solution due to a low standby power consumption compared to traditional transformer solutions. The exchangeable mains and output cables make it easy to exchange cables due to wear and tear and ensure a safe application and worldwide compa- www.cim-med.com Simply lighter CIM med’s cable integrated mounting solutions and unique medical carrier systems for modern clinical operations. We carry your concepts farther tibility. The new product family is completed by the addition of the FS3 foot switch which is simple and intuitive to operate and, in addition to the floor model, a model for direct mounting on the side of a bed frame will be released shortly. If it is necessary to have a foot switch for control of more than one movement, the modular construction of the FS3 allows it to be extended according to the needs. Products based on LINAK’s OpenBus technology, allow to attach accessories, such as:USB hub, reading lamp or an infrared hand control, thereby broadening the range of uses. Thanks to OpenBus, the service data are recorded in the actuators and can be easily read out. www.linak.de Laboratory Devices Piezoelectric Drives Neither magnetic fields, humidity or vacuum influence the performance of piezoelectric drives. In laboratory automation, especially the drives that can be easily integrated are of great advantage. Small, Fast, and Precise L aboratory automation is a very special field of automation engineering. It is concerned with the automation of laboratory processes in chemistry, bio-engineering, pharmaceutical and food technology as well as medicine aiming to improve the reproducibility of the processes and save time and costs through automation. Undoubtedly quite different from each other, the various markets have one crucial thing in common: they need fast and precise drive systems. If the application so requires, they must also be as compact as possible or operate reliably even in strong magnetic fields, at low temperatures and in a vacuum. Piezoelectric drives, scanners and positioning systems are a safe bet here, ranging from pumping and dosing tasks through sample manipuContact lation to fully-automatic screening. Physik Instrumente GmbH & Co. KG The precise supply of sub76228 Karlsruhe/Palmbach stances is one important Germany field of laboratory automaPhone +49 (0)721 48460 tion. The compact dimenFax +49 (0)721 4846-1019 sions, high precision and www.pi.ws dynamics of piezoelectric MED engineering INTERNATIONAL 2013 drives combined with their low purchasing and maintenance costs make them indispensable for micropumps and nanoliter dosing. The same applies to piezoceramic disks for generating fast oscillations Precise pumping as well as for actuators with strong and dosing acceleration at strokes of 10 to 1000 μm, and piezomotors for fast motions in the range of several millimeters. Physik Instrumente offers a comprehensive product portfolio for these applications. Micro-diaphragm pumps are a typical exemplary application of piezoceramic actuators. They work in a similar way to piston pumps but the medium to be transported is separated from the drive by a diaphragm (Figure 1). The drive can therefore not interfere with the pumped media and vice versa. Highly dynamic, disk-shaped, piezo elements mounted directly onto a metal disk lend themselves to the miniaturized version of this type of pump. High delivery rates can thus be realized even under backpressure by varying the switching frequencies or the amplitude of the piezo displacement by means of a corresponding control. Micro-dosing valves operate in a similar way to pumps but the forces required are higher. The common dosing frequencies in this application are usually in the kilohertz range and can be imple- 20 © Carl Hanser Verlag, Munich Photos 1 and 3: Physik Instrumente 3 The lamellae are readjusted individually by compact drives in order to predetermine a certain shape and eliminate undesired peripheral effects of the illumination and/or radiation >>> f a s t f o r w a r d s o l u t i o n s 1 The precise supply of substances, e.g. by micro-diaphragm pumps, is one important field of laboratory automation. The "driving force" is a disc-shaped piezoceramic 5 ISO 1348 Certified mented only with piezo actuators. A variety of piezo components are used in the micro-dosing valves, depending on their size. For example, small piezo tubes are used for drop-on-demand methods, like in ink jet printers. Miniaturized valves for dosing tasks in the nanoliter range are produced using piezo disks, for example, which are also used for lab-on-a-chip applications. Valves requiring larger strokes can be implemented by piezo actuators with a lever system. They are suitable for longer travel and thus also for applications in which certain drop sizes have to be achieved as a function of the material properties. Of particular interest in this context is the piezo-driven direct displacement method used in PipeJet dispensers (Figure 2) which differs from most of the common piezo dosing methods in two crucial ways: The fluid line does Proper system for not consist of glass or steel capillaries, but is made from an elastic positioning tasks polymer tube that has a defined internal diameter and is not permanently attached to the piezo actuator. This means that any parts contaminated by fluid can be easily and cheaply replaced. Automation in laboratory environments is often necessary because ambient conditions restrict the accessibility, e.g. in vacuum, magnetic fields, radiation or because components are integrated deeply into the system. Small, precise, and reliable piezo drives are the proper solution for this task. Typical applications include multi-leaf collimator apertures, in which small lamellae are readjusted individually by compact drives in order to predetermine a certain shape and eliminate undesired peripheral effects of the illumination and/or radiation (Figure 3). Similar requirements apply to sample manipulation or alignment of optical imaging systems by miniature drives. For this purpose, PI offers a large selection of appropriate positioning and handling systems based on different piezoelectric working principles: for example ultrasonic piezo drives are well-suited for many applications requiring high dynamics (Figure 4). Working as direct drives, they dispense with the mechanical components of classic motor spindle-based drive systems such as clutch or gearhead to the benefit of costs and reliability. They are lightweight and suitable for travel speeds up to approximately 500 mm/s, their accuracy is in the range of approximately 50 nm. Since they are offered in various steps of integration, they are easy to adapt to the application on hand. 21 Customized drive solutions 3 Near Patient Device 3 Electronically Enabled Drug Delivery (EEDD) 3 Infusion and Medication 3 Ambient Assisted Living www.buehlermotor.de We look forward to seeing you at: Pharmapack Europe in Paris Grande Halle de la Villette, Booth 475 13. – 14. Feb. 2013 Medtec Europe in Stuttgart Hall 3, Booth 3G49 26. – 28. Feb. 2013 Bühler Motor GmbH Postfach 450155 90212 Nuremberg Germany Tel.: +49(0)911 / 45 04 - 0 Fax: +49(0)911 / 45 46 26 info@buehlermotor.de Laboratory Devices Piezoelectric Drives The PIFOC Z drives (Figure 6) for the objective lens can be designed to be very small and stiff. This allows them to respond with short slow fast release displacement response times and position very precisely active due to the good guiding, even with relativepiston area ly long travel ranges. Furthermore, motionby by actuator actuator related disturbance of the sample can be ruoutlet led. Designed accordingly, the PIFOC Z drives Io channel can move individual objectives or the entire revolving nosepiece depending on the appliorifice cation. However, there are also reasons for moving the sample instead of the objective during focusing, e.g. when the optical path jet ejection is not supposed to be changed or the structu© MED engineering INTERNATIONAL re of the microscope makes this a good idea, e.g. with inverted microscopes. In this case, 2 The PipeJet technology uses piezo-driven direct displacement for dosing scanning piezo stages whose aperture can accommodate either the sample holder or microtiter plates are then practical. In microscopic studies involving long exposures or where the samPiezo-based inertia drives are considered to be particularly comple behavior needs to be observed for extended periods of time, pact and inexpensive micro-drives. They utilize the stick-slip it is important to stay exactly at the same position and/or the comeffect for fine steps with step heights of less than a micrometer. pensate for any drift in the direction of the z axis. A typical examA piezoelectric actuator expands and takes along a mobile rod. In ple is the investigation of dynamic processes in living cells. In this the second part of the motion cycle, the actuator contracts so raapplication, it is most important that the drives that are used can pidly that it slides along the moved part, which cannot follow this tolerate the moist and warm conditions in the incubator and that motion due to its inertia, and thus remains in the same position. these systems integrate well into the feedback systems. The electric control is easy and simiFocusing on the Piezo drives thus have an advantage even with such focus stabililar to a saw-tooth voltage. The zation applications with drift tracking: moisture does not impair drives are small, which opens up object’s surface the functioning of the PICMA actuators used, and the digital conmany application areas. Typical aptrollers can be integrated well in the higher-level plications for this drive principle range from soldering tip positiosystems. They make it possible to switch between ning to shutter adjustments in micromanipulation. High forces an internal sensor in the drive and an external and a high resolution are achieved when piezoelectric one. For example, a signal that is proportioinertia drives are used to move screws, which allows the automation of alignment tasks in inaccessible places. Depending on the design, they are operated at a frequency of 4 PILine ultrasonic direct drives 20 kHz, which means that they cannot be are lightweight and suitable heard, and reach velocities of up to for travel speeds up to approx. 500 mm/s and 10 mm/s (Figure 5). accelerations of up to 20 g. The autofocus function is one of the tySince they are offered in pical applications of piezo drives in mivarious steps of integration, they are easy to adapt to the croscopy, i.e. the focusing on the desired application on hand object plane or surface of the sample. In order to guarantee the quality during analysis, the focus needs to be readjusted for each samnal to the distance between objective lens ple with the shortest step-and-settle times possiand sample can be used as external sensor signal ble. This task is assumed by the piezo drive. The (actual value). If the distance between objective lens and samspeed requirements of autofocus applications are ple is set so that the desired structure of the sample is sharply dehigh where high throughput is essential. Moreover, the fined, the corresponding sensor value can be fed to the piezo conradiation of fluorescent tracers can have toxic effects on the cells troller as a target value. If the distance between sample and obwhich is yet another reason why the time factor is so crucial in fojective lens then changes due to drift processes – which shifts the cussing. Whether the piezo drive moves the objective lens, the plane of focus in the sample –the piezo controller adjusts the volobjective nosepiece or the sample along the optical axis in autotage on the piezo drive until it changes position enough to comfocus applications depends on the application on hand. MED engineering INTERNATIONAL 2013 Ii 22 © Carl Hanser Verlag, Munich Figure 2: Source Biofluidix; Photos 4 to 6: Physik Instrumente inlet channel MG110017 www.med-eng.de @ 6 PIFOC Z drives cannot only be used to adjust individual objective lenses, but the entire objective nosepiece as well 5 Bar drive with piezoelectric stick-slip drive for speeds of up to 10 mm/s pensate for the drift. This keeps selected sample structures in focus to extended periods of time. The same system can therefore be used for drift compensation in the Z direction as well as for fast Z scans. Whether the piezo drive is integrated in the objective lens holder or the stage is again determined by the application. The piezo drives operating with vertical travel between 0,1 and 0,5 mm can often be directly integrated in the existing XY sample scanner (Figure 4) due to their compact design. This means that all common sample holders for object slides up to microtiter plates can still be used. The low total height of the full XYZ system allows for the use under all common microscopes and integration and control are as simple as with a classical XY stage. XY stages as used in microscopes, for example, for the positioning of samples during scans, should be as flat as possible to make them easy to integrate and allow easy access to samples or, in the case of inverted microscopes, permit the revolving nosepiece and other elements below the stage to be reached. Flexibility with regard to velocity and reMicroscope stage with solution is also essential ultrasonic piezomotors to be able to use microscopes for different tasks. Microscope stages operating with ultrasonic piezo drives meet all pertinent requirements in optimal manner. As linear direct drives, the compact piezomotors render lead screw ducts and flanged-on stepping motors dispensable. In addition, they are selflocking at rest and thus hold the stage in a stable position. With an overall height of just 30 mm, they are extremely flat and suitable for travel between 85 and 135 mm. The large aperture accommodates holders for Petri dishes, standard object slides or microtiter plates. The ultrasonic piezo drives used in this application allow for constant speed over a wide range from 10 μm/s to 100 mm/s. The stage can thus be used for direct visual observation at high magnification (objective lens 100x at approximately 10 μm/s) without "jerking" disturbing and tiring the user on the ocular lens or monitor while controlling the XY stage with the directly connectable USB joystick. The user will also appreciate how quietly the stage works. The same microscope stage is equally well suited for automated scanning applications that require high speeds of up to 100 mm/s and short settling times. In combination with a linear encoder, position resolution is 0,1 μm, and the bidirectional repea- 23 tability is 0,4 μm. As a result, so-called points of interest can be reliably found again and precisely approached. This is also advantageous in high content screening analysis technology, when large numbers of samples (e.g. tissue samples) are to be scanned. In addition to short settling times, the good repeatability is important here for "tiling" the images. This large number of application options demonstrates that laboratory automation without piezo-based drive solutions is hardly conceivable any longer. Easy operation even of complex motion sequences and simultaneous easy integration in the control software of the user are important requirements for modern motion controllers. Especially in laboratory automation, an additional requirement is the compatibility with common software packages from thirdparty suppliers such as, Lab View, Manager or MetaMorph. Controllers made by PI meet these requirements, e.g. by the PIMikroMove user interface, driver components that are compatible across different systems and a uniform command language, the General Command Set (GCS). All necessary components for PI controllers are included in the standard scope of delivery. Focus stabilization Dipl.-Phys. Steffen Arnold is Head of Marketing and Products at Physik Instrumente (PI) in Karlsruhe, Germany. s.arnold@pi.ws MED engineering INTERNATIONAL 2013 Laboratory Devices Rapid Manufacturing Germany-based Zellwerk is using single-use bioreactors. The rapid injection moulded parts are made from special plastic resin with carefully controlled surface finish properties and open up completely new perspectives in the world of regenerative medicine. 1 The system is made up of a hatchery (left) and a measurement and control module. In the hatchery you can see the core part: the single-use bioreactor in which the cells grow W hen it comes to the war on cancer, the body has its own front guard: Natural killer cells are able to destroy their cancer cell rivals and prevent viral infections from spreading. Unfortunately, the immune system in many patients is already weakened to such an extent that it cannot produce enough of these precious cells. Now however, the German company Zellwerk has succeeded in cultivating cells outside the human body in greater quantities than ever previously achieved. MED engineering INTERNATIONAL 2013 Zellwerk, a specialist in cell culture and tissue engineering, performs the task using single-use bioreactors manufactured using injection moulded components. Prof. Dr. Hans Hoffmeister, CEO of Zellwerk, describes the system while holding an inconspicuous, transparent plastic part with a lid in his hands. »Our bioreactor meets all the requirements necessary to produce the body's own cells in the same quantity as drugs, in a standardized and repeatable process«, he says. »The patented system is both a revelation in regenerative medicine and the dream of biomedical scientists. It takes a sample from the patient such as blood, isolates the immune cells, cultures them outside the body in large quantities, and leads them back to fight tumour cells.« The Zell system is called ›Z RP Technology‹ and comprises an incubator, located in the sterile work chamber of the bioreactor, and a special adapter (Figure 1). An external control unit monitors, controls and documents all of the parameters. »It is critical that laminar flow is created in the plastic reactor«, explaines Hoffmeister. »The cells are placed on the bottom of the reactor and flushed evenly without creating turbulence. Simultaneously, cells with oxygen and fresh medium are supplied, while spent media is transported and a constant pH maintained.« To ensure the repeatability of the process, the vital element of the challenge was to create a special surface in the reactor offering the optimum amount of friction – not too smooth and not too rough. Construction Manager Rainer Mausolf summarizes the requirements for the reactor resin and its surface condition: »The choice of plastic was crucial because we needed to provide constant chemical and physical conditions in the reactor. We tried several com- 24 © Carl Hanser Verlag, Munich All figures and photos: Proto Labs Finished Parts Within Ten Days » We rely on parts of real material. Substitute materials, offered by traditional prototype methodes, are useless to us.« Prof. Dr. Hans Hofmeister, CEO of Zellwerk, Germany mon plastics but had difficulty in finding a material that was resistant to sterilization by gamma-rays. Finally, with the help of Proto Labs, we found the optimum resin for our system«, he says. »Proto Labs also helped extensively with the implementation of our surface requirements. In Z RP Technology systems the cells must not be free to be rinsed around and therefore require a finely grained surface on which 2 left: the data of the MP50 version was uploaded directly from the 3D-CAD SolidWorks Software into the Protomold quoting system. Within a short period of time the quote and the parts were delivered. Right: the they find support. Only this sensor stick makes it possible to have a standard, repeatable protation. Within days we received the first reactors and adapters cess. To keep the conditions uniform throughout the system we made using our special plastic.« have a probe upstream of the reactor adapter that continuously Hoffmeister indicates: »For Zellwerk this is both the most ideal and measures the pH, temperature and oxygen, and relays this data to least expensive solution. We absolutely rely on parts made of ›real‹ an external control unit.« material. Substitute materials, such as offered by traditional protoAll the bioreactors and probe adapters (in different versions) used type methods are useless for us. Within Z RP Technology are manufactured using the Protomold rapid out Proto Labs, we would have never Order by injection-moulded parts service. »At first we could not believe the made as quickly and inexpensively a uploading the speed and reliability of the service«, says Mausolf. »We knew of no fully functional bioreactor for growth 3D model other suppliers who could of the body's own immune cells that deliver finished parts within meets the stringent requirements of ten days of transferring the Contact regulatory agencies.« According to Zellwerk, the Z RP Technology 3D model. Sometimes we ProtoLabs Ltd. bioreactors now represent the most advanced cultivation technowould even receive compoD-74821 Mosbach/Germany logy commercially available for adherent cell types and tissue enginents within five days, if we Phone +49 (0)6261 6436947 neering purposes. had opted for this. Fax +49 (0)6261 6436948 The process was simple: I www.protolabs.de just uploaded my 3D SolidZellwerk GmbH Works model (Figure 2) to D-16727 Oberkrämer the Protomold website. AlOT Eichstädt/Germany most immediately my Phone +49 (0)3304 382680 Thomas Löffler quote arrived and shortly Fax +49 (0)3304 38268-90 is at M.A.T.C.H. Sales Marketing www.zellwerk.biz after I was contacted with in Balingen, Germany. MG110021 www.med-eng.de thomas.loeffler@match-bl.de valuable tips on implemen- @ 25 MED engineering INTERNATIONAL 2013 New Products Micro Disc Pump Piezoelectric pressure generation. TTP has invented a miniature gas pump that replaces traditional mechanical operation with ultrasonic pressure generation technology in order to reduce size and provide silent running. The micro disc pump has already been commerzialised in a wound therapy application and is suited to other portable medical applications such as blood pressure measurement, as well as micro-fluidic and industrial applications where size, noise and controllability are important design factors. Disc Pump’s ultra-slim design is achieved by using a piezoelectric actuator to drive pressure oscillations in a thin disc shaped cavity: one current model measures just 4 mm in thickness. Silent operation is achieved by running the pump at frequencies above the limit of hearing, using special custom, high-speed valves to rectify the pressure oscillations. According ot TTP, the combination of pressure generation technology and high frequency operation make it possible to deliver pneumatic performance significantly higher than traditional pumps of comparable size. With a wide dynamic range, the technology has already achieved stall pressures in excess of 600 mbar and flow rates of more than 2500 cc/min. The high-frequency piezoelectric mechanism provides virtually ripple-free output compared to the pulsed output that characterises most conventional pumps. »We see a trend towards miniaturization, portability and discrete operation in markets such as medical devices, diagnostics and electronics driving demand for small, silent, high-performance pumps«, says James McCrone head of the group at TTP responsible for micro-devices. www.ttp.com/ technology/microdevices/pumps Electronic Assembly announced its EA DIP203-4 LCD module at electronica in Munich. It is made for applications that require exceptionally good readability. The module features a high-contrast, alphanumeric LCD supertwist display for four rows of text at 20 characters per row. Standard LED background illumination makes the text even more legible. Users can choose from black text on a yellow/green background, white text on a blue background, and black text on a white background. An automatic temperature compensation facility eliminates the need to adjust the contrast. The display is driven by Dot-Matrix Display a built-in controller of type SSD1803, which is 90 percent compatible with the HD44780 controller. The character set that ships with the display supports 240 letters, numbers, and symbols; users can also define eight characters of their own. The controller receives its control commands via a SPI interface. A four and 8 bit databus interface is also available. www.lcd-module.de Quad Lock Connector Enhances diagnostic functionality ITT Cannon has released a Zero Insertion Force (ZIF) Quad Lock Connector (QLC) for use in medical imaging and diagnostic equipment. Reducing the spacing from the standard DL line to 0.8 mm makes it according to ITT up to 65 percent smaller than existing DL products and competitive QLC products. This allows a reduction in the overall size of diagnostic equipment. The high pin count of 260 positions offers multiple channel options and makes improvements to image resolution possible at the design stage, which will ultimately re- MED engineering INTERNATIONAL 2013 sult in enhanced diagnostic functionality. The ZIF QLC connector system exceeds 20 000 mating cycles. Utilizing two 130 pin PCB surface mount connectors makes it more flexible in customer PCB designs. The component incorporates an extended insulator to secure the four locking pins and more than double the connection retention force. This provides a very strong connection over the whole life of the system. The insulators are packaged for easy PCB installation, which decreases assembly time by over 15 percent. The connector has a strong zinc die-cast outer body and grounding springs which protect the equipment against radiated EMI/RFI interference. Latching is both audible and tactile and is supplemented with two integrated cams and four innovative locking hooks to ensure positive mating and prevent inadvertent disconnection by the operator. The connector is fully intermateable with competitive products, so customers can upgrade exis- 26 ting designs with the ZIF QLC. When upgrading to the QLC, legacy products remain fully functional in the transition period. Typical medical applications include ultrasound scanners, where the connector is used to send data from the ultrasound probe to the base device and other medical equipment where it feeds data from swappable probes to the connected base device. www.ittcannon.com © Carl Hanser Verlag, Munich Einzigartig in der Vielfalt Unique in diversity Wir produzieren hochpräzise feinmechanische CNC-Drehteile, -Frästeile und drahterodierte Teile für die unterschiedlichsten Bereiche der Medizintechnik, Sensorik, Mess- und Regeltechnik. High-end Graphics Performance Send and receive data simultaneously congatec offers COM Express boards with 3rd generation Intel Core. Offering a choice of three versions, the company now provides maximum graphics and processing power for both Type 2 and Type 6 pin-out. The key innovations of the 3rd generation Intel Core processors include 3D tri-gate transistor design, 22 nm production and a more tightly integrated graphics core. Featuring up to 16 GB of dual-channel DDR3 memory (1600 MHz) the modules provide greater security thanks to Intel VT (Intel Virtualization Technology) and optional Intel AMT (Intel Active Management Technology) 8.0 support. The conga-TS77 module variant is based on the Type 6 Pin-out for new designs and supports four native USB 3.0 ports. Benefits include faster data transfer, lower power consumption and the possibility to send and receive data simultaneously. Three combined independent Digital Display Interfaces (DDI) provide SDVO, HDMI or DisplayPort, while direct PCI Express x16 lanes (PEG 3.0), LVDS and VGA are available as separate graphic interfaces. For existing project designs, the company now offers two module variants for Type 2 Pin-out on COM Express for maximum graphics performance. In accordance with the COM Express specification, the congaBP77 module features PCI Express x16 lanes (PEG 3.0), LVDS and VGA graphic interfaces. This module is suitable for applications that are based on PEG graphics and require an external highend graphics performance. PEG is implemented via a custom carrier board. The schematics of the evaluation carrier board conga-CEVAL, which are available for free download, provide a template for the development of the application specific carrier board. For existing project designs on Type 2 Pin-out requiring a maximum of flexibility with regard to the graphics interfaces, the company offers the conga-BS77. It dispenses with the PEG interface in order to execute three independent Digital Display Interfaces (DDIs). Each can be configured as DisplayPort or TMDS (HDMI or DVI). In addition, one port can also be configured as SDVO output. LVDS and VGA are available too. Up to seven PCI Express lanes, four SATA ports with up to 6 Gb/s and RAID support, eight USB 2.0, one EIDE and a Gigabit Ethernet interface allow fast and flexible system extensions. In addition to DirectX 11 and OpenGL 3.1, OpenCL 1.1 is also supported. Fan control, Intel High Definition Audio, LPC bus for easy integration of legacy I/O interfaces, Intel AMT 8.0 for remote maintenance and the new UEFI pre-boot applications round out the feature set. Matching carrier boards for quick evaluation and as a template for customer specific designs are also available for COM Express Types 2 and 6. We manufacture mechanical and precision engineering CNC-turned and -milled parts as well as wire-eroded parts for a variety of applications including medical technology,sensor systems, measuring and control technology. www.congatec.com Helmut Klingel GmbH · CNC-Zerspanung Hanauer Straße 5-7 · 75181 Pforzheim (Germany) 27 Telefon +49 7231 6519-0 · Telefax +49 7231 6519-71 www.klingel-cnc.de · info@klingel-cnc.de Sensors support many task in laboratory automation and make sure that the processes are reliable, precise and efficient. Filling the microtiter plates with the liquid to be analyzed is an imncreased automation in lab technology also increases the ways portant part of the workflow. Sensors measure the fill level of the miin which sensors can be utilized to support and make sure that a crotiter plate wells after a small amount of the substance has been wide variety of tasks involved in automated lab processes are propipetted into the container and before the analysis process actually perly executed. This is exactly why sensor and measuring instruments begins. The sensors are thus able to check whether the amount is manufacturer Baumer has developed a wide variety of solutions that sufficient for the analysis or if too much liquid has been put in. Doing ensure automated lab processes are reliable, precise and efficient. this keeps waste to a bare minimum. Important qualities that system Labs are where new diseases, vaccines or even artificial ingredients manufacturers and users require of sensors are primarily precision are studied and further developed. Growing automation in lab prowith good repeatability and a high slew rate. Furthermore, very little cesses thus contributes to economic Measure the space is available for measuring the fill level. Some of the individual efficiency. Even in the labs themselwell openings only have a diameter of 3 mm. The sensor must be ves, activities such as pipetting or fill level precisely able to detect the smallest deviations in the shortest amount of time analyzing samples are primarily conthrough such narrow openings. ducted today by machines. Machines work more efficiently and more Conventional ultrasonic sensors operate by sending cone-shaped precise than people. Sensors are visibly at work behind the scenes sound waves. Because of this, their measuring spot size is too large ensuring high process safety even with increased throughputs and to be able to take a measurement inside openings that have a diamespeeds. Valuable samples especially call for precise measurements ter of less than 10 mm. By working closely with customers, Baumer with good repeatability. Sensors must also be able to withstand harsh was able to develop the 09 series to circumvent this limitation. These chemical substances or feature a respective hygienic design. ultrasonic sensors are only 9 mm wide and are equipped with a speThe ways in which the different sensor solutions can be utilized in cial nozzle that focuses the sound waves, thereby enabling the senlab automation is very extensive. They provide reliable support at the sor to take measurements inside the very small openings of a micronumerous interfaces of the lab process. One of their most frequent titer plate. Depending on the installation procedure, the nozzle can tasks is measuring the fill level of liquids in analysis processes. Baube attached to the front or side of the sensors. mer utilizes a wide variety of sensor technologies The nozzle can be detached and replaced which for this. In addition, very small containers such as makes it easier to clean the sensor. Naturally, microtiter plates and test tubes are used. Level conContact these sensors are also capable of taking measutrol can ensure that replacing or refilling a contaiBaumer Group rements in larger openings. ner can be scheduled in advance, and Baumer ofInternational Sales The sensors achieve a very high resolution and fers various sensor technologies to accomplish CH-8501 Frauenfeld/ repeat accuracy of up to 0,1 mm, which in a 384this. The portfolio range includes capacitive, phoSwitzerland well microtiter plate, corresponds to a volume toelectric and ultrasonic sensors. For example, with Phone +41 (0)52 7281122 resolution of 1 μl. It has a very fast response time the 09 series of ultrasonic sensors, Baumer is meeFax +41 (0)52 7281144 www.baumer.com ting the challenge of being able to quickly and preof only 7 ms. Thanks to the special housing width cisely measure fill levels in these containers. of only 9 mm, the sensors are ideally suited for MED engineering INTERNATIONAL 2013 28 © Carl Hanser Verlag, Munich Photo: Baumer GmbH Process Safety in Laboratories I Laboratory Devices Sensors MG110016 www.med-eng.de 1 The ultrasonic sensor of the 09 series measures the fill level of liquids inside the very small openings of a microtiter plate cascading. Using this approach, eight sensors mounted in a row can scan a 96-well microtiter plate in a single pass. Ultrasonic sensors are based on the principle of measuring the propagation time of sound in air. The sensor emits ultrasonic sound waves that are inaudible to the human ear. These sound waves bounce off an object and are picked up again by the sensor. Having this functionality means the sensors Identify and are able to operate without any contrace samples tact at all. This is especially advantageous in the lab area since neither the medium to be analyzed nor the sensor are contaminated by the measurement process. In addition, an ultrasonic sensor is exceptionally insensitive to relative humidity and dust which allows it to constantly work reliably. Since it operates with sound waves, it can reliably detect a wide variety of media regardless of transparency or color. The consistency of the medium to be examined does not impact the measurement either. But there are numerous other applications that are able to make lab automation more efficient. For example, vision sensors such as VeriSens are used for the important identification and traceability of the samples. With the ID function of VeriSens, it is possible to read the coding on test tubes or microtiter plates, such as barcodes, matrix codes or text. The ability to combine several features makes it possible to conduct various inspection tasks in one step. @ Precise positioning of pipetting arms is ensured by encoders which Baumer offers in various versions. Depending on the application, either absolute or incremental encoders are used to determine the position information. To prevent errors from happening even early on in the sample processing, photoelectric or ultrasonic sensors provide an essential added value in pipette tip recognition by safely identifying the type and number of the pipette tips. Baumer has developed solutions that especially have the required compact housing, a very high resolution of up to 2 μm, and an incredibly short response time of less than 1 ms. Fluid leaks or leakages that go unnoticed can be particularly dangerous and expensive in lab automation. Photoelectric sensors provide a reliable and constant way of monitoring this issue. Baumer's FODK 23 leak-monitoring sensor can detect a leak that is as small as 1 ml. A special Teflon PFA coating makes it also able to withstand chemically aggressive liquids. Sensors ultimately contribute to the efficiency of lab automation. They are able to recognize errors early on and thus maintain a high level of quality. Sensors ensure flexibility and reliability thanks to their precision and the wide variety of applications that they can be used in. Stefan Diepenbrock is Manager Public Relations at Baumer Group in Switzerland. sdiepenbrock@baumer.com Company Profile Pumps and systems for gases, vapors and liquids! KNF Neuberger GmbH Germany Alter Weg 3 D-79112 Freiburg Tel. +49 7664 5909-0 Fax +49 7664 5909-99 info@knf.de www.knf.com For nearly 50 years KNF has been producing and marketing diaphragm pumps and systems. These are used when gases and vapors need to be pumped or compressed, when containers need to be evacuated and liquids pumped or metered. The products are found for example in equipment used for medical technology, analytics and environmental technology. A variety of other applications such as in laboratories, the cleaning industry and research round out the range of uses. The product line extends from small, fingernailsized gas and liquid pumps to liquid metering pumps up to large gas sampling pumps with a flow rate of 280 l/min (at atmospheric pressu- 29 re). A modular system for the pump head components and for the drive motors enables a large number of stock configurations while forming the basis for custom product modifications. Over 32,000 such projects have already been carried out. A great advantage of the KNF diaphragm pumps is their oil-free operation, which ensures unadulterated pumping of the media without contamination. The units are also maintenance-free, compact and quiet. Thanks to the option of chemically resistant materials such as PTFE and FFPM for the pump head and valves, as well as a PTFE coating on the diaphragm, diaphragm pumps for use with corrosive and aggressive media are available. Special designs round out the product offering, including pumps which conform to ATEX for use in potentially explosive atmospheres, or pumps with heated pump heads. KNF is an independent, innovative family group with headquarters in Freiburg/Germany and around 600 employees worldwide. The group includes a global sales organization with 16 subsidiaries and a large number of representatives www.knf.com in major industrial countries. MED engineering INTERNATIONAL 2013 MED electronics Q7-Computer-on-Module Digital signal processors improve image processing and quality in ultrasonic and X-ray applications. With compact Qseven modules development time of these applications will be significantly reduced. tial still images are possible with 3D ultrasound imaging products. ltrasound imaging products used nowadays for medical dia4D ultrasound imaging even permits three-dimensional displays in gnostics and therapies have become indispensible. The adreal-time. Cross section views of a particular organ from any viewvantage of this method is that the sound waves, having a ing angle can be generated or a virtual journey can be made through frequency of between 1 and 40 MHz at a medium sound intensity the human body. of 100 mW/cm2, are not harmful to animal or human tissues. The High-performance Computer-On-Modules (COMs) are increasingbasic technology, also called sonography, makes use of the diffely often used for fast development of innovative ultrasound imarent reflections of the ultrasound on the boundaries between tisging products. COM-based solusue and air, acoustically different tissues and on the boundaries COMs are tions offer standard PC functionabetween bone and tissues. The main applications in the medical manufacturer lity on the processor module and sector include gall bladder and kidney examinations, cardiology, gyapplication-specific functions on a necology, tumor detection, radiotherapy and ophthalmology. independant specially designed baseboard. The In addition to electronics for the sound generation, an ultrasound module is easily mounted on the baseboard via the proven stanimaging product comprises signal processing and image display, a dard connector. Hence, the development complexity variety of interfaces for the connection of and design risk can be substantially reduced and dea monitor and printer as well as for stosign times can be significantly optimized. The embedrage media or a video camera. The ultraContact ded modules offered meet defined standard specifisound probe (transducer head) is concations regarding format and performance and are nected to the main unit via a cable. PrintMSC Vertriebs GmbH D-76297 Stutensee/Germany therefore interchangeable with products from diffeouts (sonograms) or video recordings can Phone +49 (0)7249 9100 rent manufacturers. Furthermore, as a rule, a range of be prepared as documentation from the Fax +49 (0)7249 7993 different versions with scalable processor power are monitor images. Ultrasound imaging prowww.msc-ge.com offered, thus enabling a simple upgrade to a higher ducts are available in a range of different models, for example, small portable systems in personal digital assistant (PDA) 1 The Q7-TI8168 format or large desktop types. Qseven platform is Due to the increase in computing power, based on the DM8168 and particularly through the progress in DaVinci Digital Media Processor, which intedigital signal processing, the image quagrates an ARM Cortexlity of ultrasound imaging products has A8 RISC MPU and the TI continued to improve in recent years. C674x digital signal processor (DSP) core For example, by means of digital sound wave coding it is possible to clearly differentiate between ambient noise and the sound wave used for image generation and thus improve the image resolution. Furthermore, beside the two-dimensional, color-coded Doppler method, the amplitude-coded power Doppler technology was developed. Spa- MED engineering INTERNATIONAL 2013 30 © Carl Hanser Verlag, Munich All photos: MSC Vertriebs GmbH ARM and DSP Ensure Rapid Imaging U » DSPs are designed for demanding data and imaging processing analysis and reduce the workload of the ARM processor.« Wolfgang Eisenbarth, is Director Marketing Embedded Computer Technology at MSC performance for example. Likewise, a COM that has been used for a long time can be exchanged with a more up-to-date COM, for example with optimized power management functions in order to minimize the power consumption. This possibility is particularly interesting for the implementation of mobile, battery-operated ultrasound imaging products. Today, the Qseven standard, which defines modules in a compact form factor of 70 x 70 mm, is widely accepted in many applications. In addition to support for various x86 processors, the latest Qseven Specification Revision 1.2 has added support for power-efficient ARM/RISC architectures. In 2011, as one of the first providers, MSC presented the Qseven embedded platform Q7-NT2 which is based on the NVIDIA Tegra 290 low-power processor with dual core ARM Cortex-A9. In order to meet the demanding requirements of image capture and image processing systems in the field of medical technology, MSC now offers an additional Qseven module with ARM architecture (Figure 1). The high-performance Q7-TI8168 Qseven module is based on the DM8168 DaVinci Digital Media Processor from Texas Instruments (TI). The DM8168 integrates an ARM Cortex-A8 RISC MPU (up to 1.2 GHz) and a TI C674x VLIW floating-point DSP core with up to 8000 MIPS/6000 MFLOPS. Compact and reliable Panasonic PhotoMOS relays unify the advantages of electromechanical relays and semiconductors. ◗ Linear output characteristics ◗ No threshold voltage ◗ Low operate current (HS type 0.3mA) ◗ Low output capacitance (RF type 1pF) ◗ Absolute minimum leakage current (pA) 2 The Q7-MB-EP4 baseboard ensures fast development of high-performance embedded systems, which are based on the Q7TI8168 compact Qseven module family ◗ High I/O insulation (GU-E type 5kV) ◗ Low on-resistance (HE type 0.035 Ohm) ◗ Extremely compact design (VSSOP, SON, SSOP, SOP, …) Panasonic relay technology permits fast, silent and bounce-free switching with extremely compact housing dimensions and utmost reliability. Panasonic Electric Works Europe AG 31 4ELs&AX info.peweu@eu.panasonic.com www.panasonic-electric-works.com MED electronics Q7-Computer-on-Module @ MD110024 www.med-eng.de Application Level Software User Interface Browser/Media Player Applications Application Frameworks - Java, Qt, GStreamer, Flash, Android, DShow, Direct Draw video picture language sound encoder and frameworks on NEON A OpenGL ES and OpenVG On SGX 2D Graphics Library On NEON The C6EZAccel software enables acceleration of signal processing tasks by using DSP optimized algorithms (APIs) OS kernel ARM Cortex-A8 with USB on chip, High-end CAN controller (HECC) and Ethernet MAC Accelerators – SGX 530 and Neon The use of digital signal processors (DSPs) has great advantages, especially in the area of image processing, for example in the analysis of ultrasound or radiography images in real-time. Wolfgang Eisenbarth, Director of Marketing Embedded Computer Technology of MSC, explained: »DSPs are specially designed for demanding data and image analysis in real-time. By managing these tasks, the DSPs can thus significantly reduce the workload of the integrated ARM processor. Furthermore, there is no longer the need, as in the past, for the development of specific software and its adaptation to the processor core.« The ARM NEON media processing engine, integrated in the DM8168, supports video imaging, speech, audio codes and frameworks. With the already optimized Low energy C6EZAccel and C6EZRun libraries from TI, numerous tasks such as diprocessors allow gital filtering, complex mathemobile devices matical calculations, image processing and image analysis can be easily performed. C6EZAccel (Table A) enables acceleration of the signal processing tasks by using DSP optimized algorithms (APIs). More than 130 DSP library elements such as OpenGL ES or 2D graphics are freely available to developers. C6EZRun executes the code porting, in order to run ARM code on the DSP. In addition to MPU and DSP, the DM8168 DaVinci Digital Media Processor includes 32 kB instruction cache, 32 kB data cache, 256 kB L2 cache, 64 kB RAM and 48 kB boot ROM. The Qseven module Q7-TI8168 integrates 1 GB DDR3-1600 SDRAM and a maximum of 2 GB NAND Flash memory. The Q7-TI8168 embedded platform provides standard interfaces such as PCI Express x1 port, Gigabit Ethernet interface, single channel LVDS 24 bit with up to 1280 x 720 pixels and HDMI/DVI interface. In addition, five USB 2.0 host and one USB 2.0 client as well as AC97 audio and SPI interface are implemented. Con- MED engineering INTERNATIONAL 2013 nection of a memory card is possible via the SD/SDIO interface. User data can also be stored via two SATA II channels. MSC offers the Q7-MB-EP4 baseboard (Figure 2) for immediate use in embedded systems that integrate the Q7-TI8168 ARMbased Qseven module. The high-performance embedded platform, according to Wolfgang Eisenbarth, can also be put directly into production. Thus, in many cases, this saves the customer complex in-house design effort. Because the Q7-TI8168 compact Interfaces for Qseven module is easily mounted interoperable on the baseboard via a proven MXM products connection, there is a direct thermal connection of the heat spreader to the metal enclosure. This ensures an optimal passive cooling. Thanks to the implemented Direct Digital Interfaces (DDI) the digital video signals of the module go directly to the Digital Visual Interface (DVI) connector. The baseboard measures 148 x 102 mm and provides a wide variety of important interfaces such as dual Gigabit Ethernet, five USB 2.0 ports (four external), RS-232 (pin header), AC97 audio and SATA. In addition, CAN signals are available via a special pin header. Furthermore, an ARM RS-232 debug port for Linux software development is provided. Industrial displays can be connected via the Digital Visual Interface (DVI) connector and the Low-Voltage Differential Signaling (LVDS) interface directly via JILI30 connector. Additionally, the platform integrates a controller for the connection of a resistive touch screen and supports the connection of a backlight. In order to further extend the functions on the baseboard, for example for the support of wireless local area network (WLAN), a mini PCI Express slot is provided. The mSATA slot provides an easy way to add a SATA-based Flash memory card. The baseboard can also be individually configured by customers via the integrated MMC/SD card slot. 32 © Carl Hanser Verlag, Munich Table A source: Texas Instruments Board Support Packages • Linux – Open Source – TI developed • Android – Open Soure – TI funded • Windows Embedded CE – TI owned (developed by Microsoft Gold Partner) • Commercial Linux und Android – many partners • RTOS – QNX, VxWorks, Nucleus, Integrity and others MED electronics FPGAs Instead of DSP and MCU Motor controllers are often based on user-specific circuits. However, complex applications can be developed more efficiently and economically on FPGA platforms. Sophisticated Drive Systems for Tomorrow T tems and links to customer-specific user interfaces are required. Many such applications are based on DSPs and MCUs. However, these are subject to limitations concerning performance, scalability and extensibility. Due to their power and flexibility, FPGAs offer a genuine alternative in demanding drive applications. They make it possible to integrate the functional blocks for the operation of a process controller with drives on one chip. The high control cycle rates that are achievable in combination with the high integration density and scalability play a central role in drive technology. Thanks to their high performance, FPGAs cope with a wide variety of applications in medical technology. 1 Drive controls such as in automatic liquid handling can be implemented in a highly integrated and scalable manner with FPGA technologies Photo: iStockphoto: David Gray Photography Single-chip solutions save money he requirements for motioncontrol applications in medical technology are changing constantly and place high demands on drive systems. In addition to high demands on dynamics, precision and computing power for track calculations, the central issues are the price, the form and the modularity of the system. Moreover, in integrated solutions, interfaces to other sys- 33 MED engineering INTERNATIONAL 2013 2 An evaluation kit facilitates the rapid prototyping of a functional model One advantage of FPGAs is the possibility of mapping several softcore processors within one chip. The time-critical real-time requirements can be separated from non-time-critical operations. The data traffic in systems with many bus users is thus reduced to a minimum, resulting in increased robustness. This softcore architecture offers the advantage compared with MCU systems of making it possible to combine several chips in a single chip. Besides reducing space requirements on the PCB, this also saves costs. Especially when drive-controlled systems have to be highly integrated, inherent advantages of FPGA architecture becomes obvious. The high computer power provided by the softcores and the high time resolution make it possible to achieve the required dynamics in the control circuits Control systems in and at the same time to accomreal-time with FPGAs modate the process controller on a single chip. Thus, for example, embedded processors such as the NIOS II (32-bit RISC) can take over process control with I/O, filter or interface functions, with the flexible DSP blocks providing the computer-power intensive algorithms for motor control. The high performance is reflected, for example, in the application of field-orientated control (FOC). The key to FOC's success is the real-time control of the sinusoidal, 3-phase motor current. On the basis of the motor current value that is sampled at a rate of 100 k Samples/s, all necessary control parameters such as speed, slippage moment and torque are calculated at an FPGA cycle rate of 100 MHz and the motor speed and angle are adjusted via PI control loops. The required algorithms are available and easily implemented as FPGA-IP, not only for FOCs but for all commonly available controller types. By combining Contact ready-to-use, tested IPs and Pantec Engineering AG customer-specific code LI-9491 Ruggell/Liechtenstein blocks, the time-to-market Phone +423 (0)377 1333 and hence also the time-toFax +423 (0)377 1334 cash are considerably rewww.pantec.com/dynamics duced. MED engineering INTERNATIONAL 2013 3 FPGA software modules for a comprehensive singlechip drive control However, efficiency in the development process by no means stops here. The processors available on the FPGAs make it possible to easily migrate existing C-code from process algorithms, for example, to NIOS II softcore. FPGA development systems also offer debugging tools, which permit access to the lowest levels. This creates the prerequisites for the system analyses required for FDA certifications, for example. In addition to the capacity for general control technology, FPGAs offer sufficient power for demanding, application-specific requirements. In order to read on... ...read or download the complete article in: www.med-eng.de/MG110022 Lorenzo Huber is Head of the Business Unit Dynamics at Pantec Engineering in Ruggell, Liechtenstein. lorenzo.huber@pantec.com 34 © Carl Hanser Verlag, Munich All photos and source of figures: Pantec Engineering AG MED electronics FPGAs Instead of DSP and MCU MED electronics Embedded ATX Boards The high quality of signals and images achieved with the Micro-ATX board makes it possible to perform digital Doppler and duplex sonography with one and the same device. The long-term availability of the board protects the user’s investment. Photo: Compumedics DWL Measuring the Speed of Blood Flow in Real Time Contact Fujitsu Technology Solutions GmbH D-86199 Augsburg/Germany Phone +49 (0)821 804-3177 Fax +49 (0)821 804-3177 www.de.fujitsu.com Compumedics DWL Germany GmbH D-78224 Singen/Germany Phone +49 (0)7731 797690 Fax +49 (0)7731 797699750 www.dwl.de 1 D oppler sonography makes it possible to measure the speed at which blood flows through certain vessels. Superior to more elaborate diagnostic methods when it comes to visualizing the haemodynamic situation of the vessels, sonography is a non-invasive, reproduceable method which does not expose the patient to any radiation and which enables the diagnosis of vascular anomalies and embolisms provided that the Doppler or duplex device offers a high degree of signal and image quality. Combining the Doppler and duplex technologies by using a Doppler color imaging module results in a full set which, by offering two methods, mainly supports complex applications and specialized functional tests in scientific research. 35 Today, the range of applications for Doppler systems is wider than ever and can include neurology, neurosurgery, cardiovascular surgery, anaesthesia, intensive care, or ENT surgery. With the help of transcranial Doppler sonography (TCD), vascular anomalies and embolisms cannot only be detected but also analyzed. Such blockages of blood flow in the brain precede a stroke. If they are detected and treated in time, a stroke can be prevented. Furthermore, it is possible to study CO2 reactivity and autoregulation as well as reactions to certain medicines. The Doppler M mode makes it possible to measure even through the deepest layers and to visualize the data in real time Compumedics DWL specializes in the development of devices for Doppler and duplex sonography. One advantage of transcranial Doppler sonography is that it can be performed in a flexible, quick, and cost-efficient way with portable equipment. For visualizing the blood flowing trough the brain, doctors usually use Doppler probes because this method, possibly the most current so far, is the more sensitive of the two. Duplex probes (Figure 2) are usually used for visualizing the carotid arteries at the neck which supply the brain with blood. In order to read on... ... read or download the complete article in: www.med-eng.de/MG110019 MED engineering INTERNATIONAL 2013 MED electronics RoHS and REACH Until now, neither RoHS 2 nor REACH has been a topic in medical industry. By June 2014 medical device manufacturers have to demonstrate the compliance of their products. The question is make or buy? All photos and figures : TQ-Group E10 in Electronic Medical Technology By 22nd of July 2014 all electro medical devices put on the EU market have to be RoHS compliant A few years ago, the topic of RoHS compliance came up in the electronics industry. As with every major technological innovation, there was initially a certain degree of panic in the market. Two important questions had to be answered: do all components come in identical RoHS versions? How do the production processes work, especially lead-free soldering? Some manufacturers used the changeover to clean up their product portfolio. Today, electronics manufacturers have a handle on production processes. Until now, it has not been mandatory for medical products to conform to RoHS 2. REACH was not a topic either. But this will change due to an amendment of the law by June 2014. All manufacturers, with only a few exceptions, must demonstrate the compliance of their products. What is RoHS 2 about? Additional MED engineering INTERNATIONAL 2013 hazardous material protection regulations apply to electromedical devices first introduced into the EU as of 22/07/2014. These are laid out in the new RoHS-II directive 2011/65/EU (Restriction of the use of certain Hazardous Substances), which went into effect on 21/07/2011. It replaces the earlier directive 2002/95/EC, whose scope did not yet include meFirst step: dical products. The directive must be implemented in national law no parts list analysis later than 02/01/2013. Common substances in electronics are often highly dangerous to the environment, as they are both toxic and cannot be disposed of easily or at all. RoHS is intended to prohibit these substances from being used in products. This affects the following: lead, mercury, 36 © Carl Hanser Verlag, Munich current design PowerSolutions for industrial and medical systems parts List analysis r RoHS/REACH compliant? No search for substitutes Yes edit parts List No Medical Powe + O anty 3-Years-Warr + O ailable Long-Term Av + O Yes redesign analyze production process production RoHS/REACH compliant? No make or buy? Make reorganize production DIntegrated UPS function DVarious battery packs DWith USB interface Yes E2 MS compliant product 1 mNSP3-450P-USB ATX Nonstop Power Buy The way to RoHS-2 compliance RoHS-, OM- & REACHmonitoring © MED engineering INTERNATOINAL BEO-1500M Fanless Solution cadmium, hexavalent chromium, polybrominated Contact biphenyl (PBB), and polybrominated diphenyl ether TQ-Systems GmbH (PBDE). D-82229 Seefeld/Germany According to the original directive, these substanPhone +49 (0)8153 93080 ces should not be used in products at all. Since this Fax +49 (0)8153 4223 requirement could not have been implemented www.tq-group.com from a production point of view and small quantities could not be detected analytically, concrete threshold values for homogeneous materials in the products were established in an amendment to the directive on 18th of August 2005 (sources: directive 2002/95/EG, directive 2011/65/EU). Directive (EC) No. 1907/2006 (REACH directive) is an EU chemicals directive that went into effect on 1st of June 2007. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. As an EU directive, REACH is equally and directly applicable to all member states. REACH harmonizes and simplifies existing chemicals regulations. The list of substances of very high concern contain: In order to read on... ...read or download the complete article in: DPowerful and very compact DHigh efficiency up to 93 % DExtended temperature range BET-1200M ECO-Friendly Design DErP and CEC level V compliant DPowerful desktop adapter DSecure, robust and reliable Let's meet in Hall 2.117 www.med-eng.de/MG110018 37 Bicker Elektronik GmbH Phone: +49-906-70595-0 www.bicker.de 1 C-Leg users enjoy every step Trusting the Next Step T hose who have to live with an amputation frequently have to overcome many hurdles on a daily basis – be it stairs or an uneven forest path. With the right leg prosthesis, such hurdles are easy to overcome. The C-Leg is an intelligent leg prosthesis system that makes the life of transfemoral amputation patients much easier. Worldwide, more than 40 000 supplies with the CLeg prosthesis system confirm the advantages of this unique technology. Medical technology specialist Ottobock developed the leg prosthesis. Ottobock has shown How does stable growth for many years and as global leader in the field of prosthe C-Leg work? thetics, it sets the benchmarks for the industry. The company builds on the mature C-Leg technology, which has proven itself time and time again since 1997. And up to today, C-Leg is constantly being developed further. For the current model, which has been introduced into the market in July 2011, many developments have been implemented. The prosthesis is now certified for a maximum body weight of 136 kg. The intelligent knee joint permanently detects the current phase of the gait cycle and adjusts accordingly in realtime. The knee angle sensor supplies the information needed for dynamically controlling the swing phase, depending on the respective step length MED engineering INTERNATIONAL 2013 and frequency of the prosthesis wearer. The joint hydraulically limits the maximum bending angle during the swing phase, e.g. when the leg prosthesis is in the air during the gait cycle. On the new C-Leg, various mechanical and electronic adjustments allow improved swing phase control. As a result, the prosthesis user has a more natural gait and improved ease-of-movement in the knee joint. Whether the wearer is taking the stairs or maneuvering through a packed shopping mall, taking a leisurely Sunday stroll or rushing to work – the CLeg system automatically adjusts to all situations. Contact Uneven ground, darkness maxon motor ag or a crowded environment CH-6072 Sachseln/Switzerland is also no longer an insurPhone +41 (0)41 6661500 mountable problem, as the Fax +41 (0)41 6661650 high resistance secures the www.maxonmotor.com C-Leg during the stance Otto Bock HealthCare GmbH phase and the knee joint D-37115 Duderstadt/Germany only switches to the swing Phone +49 (0)5527 848-3411 phase when it is necessary. Fax +49 (0)5527 848-1414 This significantly reduces www.ottobock.de the risk of falling when 38 © Carl Hanser Verlag, Munich Photos 1 + 2: Ottobock Healthcare GmbH; Photo 3: maxon motor AG Enjoying life to the full –taking carefree strolls through shopping malls, cycling with friends or perhaps going on a mountain hiking tour. With the right leg prosthesis, being active can be part of day-to-day life again. Ottobock and maxon motor give people new quality of life. Prosthesis DC Motors 2 On the new C-Leg, diverse mechanical and electronic adjustments allow an improved swing phase control wearing a leg prosthesis. The C-Leg also offers a special mode that allows it to be configured for various activities such as cross-country skiing or cycling. In this additional activity mode, the amount of hydraulic dampening depends on the knee angle. The initial dampening and the progression can be configured individually. Thus the behavior of the leg prosthesis can be programSmall motor, med for diverse activities beyond normal walking. To enable the proslarge effect thesis to withstand the stress to which it is subjected daily, the high-activity frame of the prosthesis is made of carbon, an extremely stable, high-quality and light material. The frame covers the electronics, the hydraulics and the battery. How exactly does the C-Leg technology work? The intelligent controller of the prosthetic system adapts to the individual gait of each individual. The control operations are performed via a microprocessor-controlled hydraulic unit that dynamically adjusts the system to all gait speeds. Simultaneously the controller ensures that the prosthesis is reliably secured during the stance phase. This tried-and-tested control mechanism is achieved by means of a complex sensor system. The sensors record the load every 0,02 seconds, or, to be more precise, the sensors measure the ankle moments above the foot fitting component, as well as the angle and angle speed of the knee joint. Thus the knee joint permanently detects the current gait phase of the prosthesis wearer. A lithium ion battery powers the C-Leg and lasts approximately 48 hours. The characteristics of the hydraulics are adapted by means of two valves. These valves are adjusted by maxon RE10 DC motors. Two motors are used in each C-Leg. Here one of the main strengths of the RE10 is its compact size. With a diameter of just 10 mm, the motor is the second-smallest DC motor in maxon motor's portfolio. This, combined with the CLL system for a long service life, played an important part in Ottobock's decision to use these high- 39 precision motors. The motors furthermore have ironless windings and neodymium magnets that allow top performance at a minimum size. 3 RE 10 DC-Motor has a diameter of Precious-metal brushes are used for me10 mm a length of chanical commutation of the motors. 17 mm and deliThis ensures detent-free running of the vers a performance of 0.75 W maxon motors, even at low speeds. During commutation using brushes, contacts are constantly opened and closed via the inductive load of individual segments of the motor winding. The sparks generated when the contacts open attack the metal brushes and commutator of the motor, by melting the surface. This brush fire reduces the life span of the commutation system of the motor. By means of the capacitors integrated in the motors, the life span is significantly increased. The CLL principle (capacitor long life) means that an additional element is inserted between two adjacent commutator segments, e.g. parallel to the opening contact. Through the use of the CLL concept, the brush fire is largely suppressed. Furthermore the spark reduction also has a positive influence on the electromagnetic radiation. In the C-Leg, the maxon motors have to operate in pulse mode or intermittent mode, that means the motor is only activated for a short period for adjustments and is not constantly in use. Ottobock estimates that nine million such adjustments are made during the life span of the C-Leg. On average, the motor performs ten rotations for these adjustments. For many leg amputees, using the C-Leg is a completely new experience. Contrary to other prostheses, the user of C-Leg do not have concentrate on every step. »It is not exhausting at all, it is impressively simple and I was really surprised. Now walking is fun again – almost like it used to be,« says Ed from America, who lost his leg in a car accident but has nevertheless been standing in a bakery for many years. The success story of the C-Leg continues as more and more people are switching to this intelligent leg prosthesis and are achieving amazing things with it. In 2011, 74-year old Roland Zahn crossed Germany on foot, from Leipzig to Tübingen – with his C-Leg as trustworthy companion. And a 60-year old woman climbed in the Himalayas at altitudes up to 4000 m with her prosthesis. Anja Schuetz is editor to maxon motor in Sachseln in Switzerland. Anja.Schuetz@maxonmotor.com MG110015 www.med-eng.de @ MED engineering INTERNATIONAL 2013 New Products KNF Neuberger has introduced the micro diaphragm pump NMS 010 for corrosive or aggressive media. It features high pneumatic performance, compact dimen- ment, only 13 mm wide. It weighs 23 grams including drive motor. Despite its size, the pump transfers 0,75 liters per minute. It achieves an ultimate vacuum of 600 mbar absolute and Micro Diaphragm Pump sions, low noise and low power consumption. The pump is very small and, by using an oval-diaphragm pumping ele- an overpressure of 200 mbar. Due to the enclosed housing, the pump generates very little noise running on an energy efficient drive motor. The product is oilfree in operation and transfers the media without contamination. The carefully selected materials for components contacting the media make this pump suitable for transferring corrosive or aggressive media. www.knf.de Modular Roll Stands Integrated cable management system. CIM med offers a mobile cart series. Conceived for daily work in a clinical setting, the roll stands are ergonomically designed, easy to clean and made of high-quality materials. Each model bears the CE mark and complies with the Medical Device Directive MD 93/42 EEC. The mobile mounts can be perfectly adapted to the needs of clinical personnel. They are made of eloxized aluminum and feature an integrated cable management system, thus offering a great deal of flexibility and meeting high standards of hygiene. The devices are easy to clean and resistant to hospital-grade disinfectants. The centerpiece is a base with five rollers that gives optimal stability and is available in a variety of versions depending on need. The small cruciform base made of aluminum can carry over 30 pounds (15 kilos) without a counterweight and is therefore a real space saver. For greater burdens, a heavier base of steel with asymmetrical cantilever arms provides the requisite stability. The two models are equipped with high-quality double rollers and are easy to maneuver. A conductive version is also available. The column of the roll stand provides many options for individual situations. All carrier arms and components can be slipped onto the C-profile of the column. In order to enable quick and efficient configuration of workstations, the company also provides baskets, cable hooks, infusion holders, drawer consoles and trays in addition to normed tracks and handles. www.cim-med.com MED engineering INTERNATIONAL 2013 Mini Circular Connectors Cost-effective for small medical devices. MiniMax from Fischer Connectors is a rugged push-pull interconnect solution for small medical devices. An all-inone 20 signal (0,5 A) and 4 power (5 A) connector with a patents-pending 24 mixed contacts passes extreme temperature tests, is sealed to 120 m (both mated and unmated) and resists 1000 hours of salt water spray. Because of its small profile of less than 7 mm inside the box the connector applies more connections into a smaller space. Nevertheless power and signal do not interfere with one another. The MiniMax is cost-effective because the connector itself is small and the 24-contact configuration can mean fewer connectors are used. Since fewer cables are needed, the entire device becomes cost-effective and stays reliable. The solution is also pre-cabled which saves time. The keying system withstands over 4 Nm of torque and the over-molded assemblies are able to withstand 40 kg of pull (break-away) force. The connector is available in three latching systems: push-pull, breakaway and screw lock. www.fischerconnectors.com HOERBIGER launches an electrohydraulic lifting column for operating tables that allows moving heavy patients. The column’s design is robust and simple and re- grees. The new model is consistent with current operating methods, in which clinic staff pays particular attention to low height in the retracted position. The product is designed for Electrohydraulic Lifting quires little space. It was developed specifically for a patients’ weight of up to 180 kg (lifting force: 3000 N) and an installation height of 450 millimeters with a stroke of 350 mm. The compact yet powerful lifting column allows lateral adjustments of ± 30 degrees and tilt adjustments of ± 20 de- 40 continuous operation with 10 000 cycles. Other features are that it is maintenance-free, energy efficient and - compared to strictly electric drive systems - very quiet and precise to operate. The lifting columns are distributed by HOERBIGER Micro Fluid in Barbing in Germany. www.hoerbiger.com © Carl Hanser Verlag, Munich Antimicrobial Cables Long-lasting hygiene benefit Leoni is using a new acid-based technology that gives plastic surfaces a germ-killing effect. The use of antimicrobial device housings, cables and cords in hospitals or doctors' surgeries can contribute substantially to increasing the standard of hygiene and minimising the risk of infection. Unwanted gaps in the hygiene chain can thereby be closed. The plastic surfaces near patients of monitoring devices and their cables can cause infections in hospitals when they are contaminated with germs. This risk can be substantially lowered with the use of antimicrobial cables whose special properties are similar to the principle of the human acid protective layer. Surfaces that are treated with this new technology very quickly display a significant reduction in germs. The effect is microbiologically verified, with the evidence provided by an accredited laboratory using a recognised measurement method and independent hospital hygiene experts. The test involved the most well-known and most frequently occurring hospital bacteria as well as germs that have developed resistance, applying various incubation periods and concentrations. The method that Leoni applies follows the Lewis acidbase theory: it involves acid ions being released on the sur- per method is susceptible to perspiration and protein, meaning that, in normal use, the antimicrobial effect on a treated plastic object is considerably lowered or deactivated. Another benefit of the new technology is that the pathogens are destroyed not from the inside, but from the outside across the cell envelope; the formation of what are known as biofilms on the cable or the device housing is thereby stemmed, and its surface can be more easily cleaned. Furthermore, the metal oxide that is incorporated in the plastic does not come under the controversial nanotechnology because of its larger grain size. www.leoni.com face of the cables that lower the pH value on the outer surface of the jacket. This restricts the cell functions of the germs and their separation, so that they ultimately die. This is made possible by permanently incorporating a special metal oxide in variable doses in the plastic matrix of the cable jacket. Even in low concentration a significant germ-killing effect is already evident. The mechanical properties of the cable remain unchanged. These innovations provide several advantages versus the hitherto common methods. A key benefit is that this acid technology maintains the hygienic effect. By contrast, the established silver and cop- Company Profile Tubes and Profiles Novoplast Schlauchtechnik GmbH Germany In den Langen Stücken 6 38820 Halberstadt Tel. +49 3941 6869-0 Fax +49 3941 6869-40 medizin@schlauchtechnik.de www.schlauchtechnik.de For more than 20 years Novoplast Schlauchtechnik GmbH located in Halberstadt / Germany produces thermoplastic tubes and profiles in highest precision for various applications in the industrial technology like machine building, agricultural engineering and numerous special applications as well as in the medical technology. We process more than 300 different plastics beginning with standard materials and ending with temperature or chemical resistant „High Tech“ materials. Our production is equipped with the latest laser and ultrasonic measurement devices. We are certified according to DIN ISO 9001 and DIN ISO 13485. In cleanrooms class 8 and 6 our medical tubes are produced covering a diameter range from 0.2 mm up to 20 mm, i.e. including micro extrusion. We manufacture monolumen tubes, multilumen tubes and multilayer tubes for various applications like e.g. infusion, transfusion, nutrition, angiography, urology, dialysis, drainage, PTCA. Besides these specialised products we offer several medical PVC/PVC-noDOP and PU tubes 41 * as a standard for infusion, transfusion, ECC and dialysis. In closely coordinated product development projects, our high-level material and technology expertise enables us to develop out specific solutions and to achieve them series-production rediness. The range of our industrial tubes contains e.g. several standard tubes like pneumatic tubes made of PU and PA, coiled tubes, insulating tubes, hydrolysis and microbial resistant tubes, chemical resistant and food safe tubes, tubes made of TPE, TPEE or PVDF and flexible (spiral coiled) brake hoses. Novoplast Schlauchtechnik GmbH – The right choice * Connecting Values – for the best connections, simply ask our sister company FLEIMA-PLASTIC www.fleima-plastic.de MED engineering INTERNATIONAL 2013 MED Informatics Model-based Software Development Software for safety-critical systems is subject to strict requirements, and so is the way it is developed. If development is model-based, it helps developers meet these requirements. Developing Safety-Critical Software M odern medical devices contain an increasing amount of software – for example for sensor control or device networking. Depending on the application, the software has to meet the requirements for safetycritical applications. The standards governing software for medical devices are IEC 62304 and IEC 61508 [1], which define requirements and MED engineering INTERNATIONAL 2013 make recommendations from the very first development phases to the finished software. Two major aspects are the early, comprehensive validation of all functional requirements and the traceability of all development steps. Models leave no room A great part of the control functions for pacemakers, infor interpretation sulin pumps, blood pumps and other devices consist of software. Because of the high complexity involved and the safety requirements, manufacturers have to guarantee that the device’s software provides exactly the functions that were specified and that the functions work as defined. 42 © Carl Hanser Verlag, Munich Photo left: dSPACE GmbH Thus, the specifications themselves must contain unambiguous, comprehensive function descriptions. Model-based development, in which a function is described by graphical models in MATLAB/Simulink/Stateflow, is a proven method of implementing these requirements. First, unlike purely textual function requirements, models leave no room for interpretation and avoid misunderstandings. Secondly, models provide specifications that are executable by simulation, which allows early verification (Figure 1). Moreover, automatic code generators like dSPACE TargetLink can directly convert the models into source code. Changes in a specification or model can therefore be simulated, verified, and then automatically implemented as high-quality code in fast iteration steps. The model and the code remain consistent at all times. The implementation can then be easily verified in various tests with tool support. For users, this means shorter development times, more efficient workflows and high-quality code. These three benefits are so convincing that the automotive and aviation industries are increasingly or even primarily using model-based development. Safety-critical software plays a key role in medical engineering, where it has to comply with standards such as IEC 62304 and IEC 61508. Safety-critical software is also developed in numerous other industries, where model-based development has become a proven and routine procedure, since it helps users meet the requirements defined in industry-specific standards. Another major aspect of developing safety-relevant software, in addition to correct functionality, is the traceability of requirements. It has to be possible to prove at any time that all the function requirements have been implemented exactly as described and have been tested comprehensively. There must be a guaranteed ability to track from requirement to implementation to associated tests and back in all steps, and even a long time after the software has been released and while it is in use. Guidelines to Ideally, all the requirements are deincrease safety fined from the very beginning, for example, in requirements management tools or in Microsoft Word or Excel documents. To ensure traceability between the requirements and the model parts that implement them, model-based development uses bidirectional links [2]. Users can therefore quickly and seamlessly track whether requirements have been met and how. In automatic production code generation, these links even reach into the code, guaranteeing complete traceability from the requirements to the model to the code. For example, hyperlinks in an HTML representation of the code lead back to the linked model part. In addition, users can generate up-to-date status reports at any time to monitor the status and maturity of individual functions. To ensure that functions are reliable, modeling and coding guidelines should be used, as recommended in IEC 62304. These guidelines contain rules and restrictions for using languages and the blocks available in MATLAB/Simulink. MISRA C [3] is an established standard for the widely used C programming language and implements these recommendations at code level. MISRA also publishes MISRA AC TL, special guidelines for the automatic production code 43 Requirements Verify requirement changes quickly by simulation Modeling + + x 1 2 0,4 KL Model Code generation c h Verify implementation easily by back-to-back tests Source code Implement specification changes quickly by code generation Compile & link obj Object code © MED engineering INTERNATIONAL 1 Workflow for model-based software development generator dSPACE TargetLink [4]. The focus is on development support for safety-critical software, so that possible sources of error are avoided at both the model and the code level. The modeling guidelines for TargetLink also particularly address safety-critical aspects. Other objectives are enhanced readability and efficient code generation. Different safety classes apply to medical software depending on the application. IEC 62304 defines acceptance criteria for each class: For example, the code has to comply to the applicable coding standards (see IEC 62304, section 5.5.3). In model-based development, there are guideline checking tools that automatically test whether these criteria have been met and automatically proove it. These tools also efficiently check large models for guideline compliance, so they can and should be used even in early stages of development. The generated source code can also be Verify completeness checked, for example, by the and correcteness MISRA C Checker. In addition to coding guidelines, the acceptance criteria also cover verification steps such as simulation, different kinds of tests, documentation and reviews: Different simulation modes for the model (modelin-the-loop (MIL) simulation), the host implementation (softwarein-the-loop (SIL) simulation) and the target implementation (processor-in-the-loop (PIL) simulation). These methods (Figure 2) avoid work-intensive iterations in late development phases and save time and Contact money by: Verifying at an early stage dSPACE GmbH D-33102 Paderborn/Germany by means of model simuPhone +49 (0)5251 16380 lation, that the model Fax +49 (0)5251 161980 and requirements are www.dspace.com correct MED engineering INTERNATIONAL 2013 MED Informatics Model-based Software Development Model-in-the-Loop Controller model Software-in-the-Loop C code on host PC Processor-in-the-Loop C code on target processor Evaluation board Plant model or stimulus signals 2 MIL, SIL and PIL simulation modes avoid exhausting iterations Plant model or stimulus signals Plant model or stimulus signals © MED engineering Verifying that the code and the mode are consistent, and that the code correctly represents the model's functionality, by simulating the generated code on the host PC Verifying seamless traceability for documenting the software development Allowing resource requirements to be estimated at an early stage by simulating the code on the appropriate evaluation hardware Comparison tests, i.e., performing tests with the same test cases or test stimuli in different simulation modes and comparing them (Figure 3) are methods that reduce the time required for the necessary tests despite a high volume of tests and low development costs. These advantages result from: Verifying that the code represents model behavior correctly and fulfills the requirements in terms of functionality Comprehensively testing for errors with tools that generate test vectors partly automatically and that support the comparison of simulation results, automatically generated evaluation, and documentation Verifying that system behavior is robust even with invalid preconditions or input values MED engineering INTERNATIONAL 2013 Code coverage tests at model and code level provide results in high-quality models and code by verifying that compared with all theoretically possible tests, the tests cases that were actually developed and executed are sufficient for covering the functional requirements. Reviews at model or code level in which the model and the code are linked to provide quicker and more complete reviews and therefore enhanced model and code quality. In model-based software development, not only can the code be generated automatically from the models, the software documentation can also be generated with a single click. Specification and implementation changes are automatically included and do not have to be documented manually. Template mechanisms and existing API interfaces enable users to adapt the form and contents of the documentation simply, quickly and individually, either as they see fit or according to formal documentation requirements. The model structure and other items such as graphical plots showing the simulation results can be added to the automatically generated documentation to represent the model's dynamic behavior. The requirement information can also be included to show the consistency between the requirements and the model. Because the requirements are linked to the corresponding model parts and code sections, requirements management software can be used to integrate the verification results directly into a status report. The report shows whether tests were already performed and passed for each component. The development of safety-critical systems imposes additional requirements and restrictions on the software development process. Experience from different industries has shown that complex, safety-critical applications can be developed successfully with model-based development and automatic production code generation. Some aspects of the model-based development processes were described as examples of how to support compliance with the requirements of safety standards such as IEC 62304 and how to automate software development steps. 44 © Carl Hanser Verlag, Munich MG110014 www.med-eng.de @ Test stimuli Target compiler and linker TargetLink C code Model Simulation (e.g., MIL) Object code Execution (e.g., PIL simulation on the evaluation board) 3 Comparison tests reduce the time required for the necessary tests even when the test volume is really big Signal comparison Results (references) Results © MED engineering Literature: [1] IEC 61508-3: Functional Safety of Electrical/Electronic/Programmable Electronic Safety Related Systems – Part 3: Software Requirements Dipl.-Ing. (FH) Sonja Lillwitz is Marketing Project Manager at dSPACE in Paderborn, Germany. SLillwitz@dspace.de [2] Tracing Requirements to Design, Tests and Generated Code, www.mathworks.com /products/simverification [3] MISRA C: 2004 Guidelines for the use of the C Language in critical systems, MISRA 2004 (MISRA (Motor Industry Software Reliability Association), www.misra.org.uk) [4] MISRA AC TL: Modeling style guidelines for the application of TargetLink in the context of automatic code generation, 2007, Version 1.0s Dipl.-Ing. E-Technik (TU) Doreen Krob is Product Engineer for TargetLink at dSPACE in Paderborn, Germany. DKrob@dspace.de Company Profile Kontron in Medical Embedded Technology for Medical Solutions kontron Germany Oskar-von-Miller-Straße 1 85386 Eching Tel. +49 8165 77-777 Fax +49 8165 77-279 sales@kontron.com www.kontron.com Kontron is a full-service medical OEM solutions provider offering customers innovation and longevity through highly integrated applicationready platforms. Kontron enables you to drive innovation with innovative products. Products are designed to enable longevity by quick design-in time and outstanding lifecycle management. Kontron understands the extensive and evolving requirements of the medical equipment industry. We strive to be the best resource possible to our customers beginning with design ser- vices and customization to environmental and agency testing, certifi cation, production and program management, and extended lifecycle management. Many of Kontron’s products and custom designs have been EN 60601-1 certified alongside the industrial environmental standards. Longevity & Lifecycle Management Kontron offers availability for boards and platforms up to 7 years, and longer. Extended Software Services The Kontron Global Software Center is the company’s central service point for handling the increasingly complex software functionalities of customers’ embedded computing solutions, thereby helping OEMs to reduce their time to market and improve the quality of applications. www.kontron.com 45 MED engineering INTERNATIONAL 2013 New Products NuSil Technology has launched a heat-cure colored inks series, MED6613-X. The colors — red, white, green, bright blue and dark blue — vastly expand the company’s color palette and provide more vibrant, creative marking options. NuSil’s inks are characterized by a long work time and non-volatile content of approximately 60 percent. Depending on the ink color, viscosities range from 800 to 3000 cP and can be decreased through dilution via compatible solvent. These two-part, addition-cure inks can be used in pad-printing and silk-screening processes for marking or coloring silicone rubber parts, Silicone Ink Colors Tritan Copolyester Unchanged after sterilization and chemical-resistant. Eastman Chemical Company’s Tritan copolyester is a BPA-free material that provides toughness and chemical resistance. The copolyester maintains clarity and color after sterilization, providing excellent aesthetic appeal. A device’s shape and dimensions also remain intact after both ethylene oxide (EtO) and gamma sterilization. Additionally, chemical resistance and solvent bonding with tube systems are not affected by either procedure. The copolyester was used by A. Hopf to design their 3-way stopcocks and Y-connectors for use in enteral feeding systems, cytostatic therapy and infusion and transfusion therapy, such as blood therapy. In relation to the use of raw material, Tritan copolyester meets the demands of USP Class VI, which judges the suitability of plastic material intended for use as an accessory for parenteral preparations, and FDA/ ISO 10993, which evaluates the biocompatibility of medical devices to help ensure patient safety. www.eastman.com such as catheters. Because their cure is accelerated with heat, these inks are suitable for applications requiring a rapid cure time. In fact, the suggested cure schedule is just five minutes at 150°C (302°F). »With adjustable viscosities and cure schedules allowing for versatility of processing, the inks can be used on a wide variety of medical devices,« says Brian Reilly, Product Director — Healthcare Materials. This line of silicone inks was a collaborative effort between NuSil Technology for silicone development and C.I. Medical, Inc. for application feedback. They are designated unrestricted and may be considered for long-term implant applications of 29 days or longer. Each lot undergoes cytotoxicity tests, and a Master Access File will be filed with the FDA for each ink color. »CI Medical, Inc., with its long term relationship with NuSil, was pleased to be involved with the development of this new series of medical grade silicone inks,« means Bruce Mahan, Engineering Manager – CI Medical, Inc. »The inks’ excellent printability and vibrant opaque colors illustrate the synergy that can be realized when combining the expertise of NuSil with that of CI Medical.« www.nusil.com Micro-Spaghetti Tubing Thin and stable walls. Reichelt Chemietechnik presents its new THOMAFLUID Micro-Spaghetti Tubing for Analytic Technology that is of particular interest especially for biochemical research. A characteristic feature of this tubing series is its high dimensional stability despite the minimum wall thickness. The smallest tubing size inside is 0.51 mm with a wall thickness of 0.91 mm. The dimensional stability is ensured by the production method since the tubing is manufactured by means of a mandrel bar. An absolutely smooth inner surface of the Spaghetti-Viton-Tubing ensures that no foreign substances can be deposited on the inner wall of the tubing. Its MED engineering INTERNATIONAL 2013 temperature resistance is –30°C to +200°C, for a short time up to +300°C, which is of great importance for laboratory technology. FKM/FPM are copolymers of highest quality made of fluorinated hydrocarbons. Fluorinated rubber belongs to the most expensive elastomers besides FFKM. Its outstanding elongation at break is particularly advantageous in peristaltic pump technology when organic as well as inorganic media e.g. vegetable and animal oils, aromatic and fluorinated solvents, many acids, alkalis and oxidants have to be delivered. The Viton MicroSpaghetti Tubing for analytic technology is available in delivery units of 1, 5 and 10 m. www.rct-online.de 46 © Carl Hanser Verlag, Munich Company Profile Improving Lives through Innovation Gardner Denver Thomas GmbH Germany Benzstraße 28 82178 Puchheim Tel. +49 89 80900-0 Fax +49 89 808368 thomas.de@gardnerdenver.com www.gd-thomas.com Gardner Denver Thomas has been meeting the pump and compressor needs of OEMs for over 50 years. Simply put, we’re specialists in serving original equipment manufacturers. In fact, over 90% of everything we produce goes into an OEM product. The performance of customers’ design ultimately depends on the quality and dependability of its components. That’s why so many original equipment manufacturers of medical equipment have entrusted their reputations to Thomas. With a wide range of pressure, vacuum and liquid technologies including: WOB-L piston, articulated piston, diaphragm, rotary vane, linear and peristaltic, Thomas offers the broadest product range in the industry. The flow range of gas pumps extends to 360 l/min with a pressure of max 12 bar and a vacuum of 99% local barometer. The liquid pump range goes to 3000 ml/min and a maximum pressure height of 80 m water column. With this vast product offering, Thomas can design an ideal, custom pressure or vacuum solution that can be prototyped and manufactured to meet the customers’ precise needs. In addition to the OEM, Thomas also designs and manufacturers a wide range of products for the construction, laboratory, leak detection and medical markets. Thomas employs over 900 people in 25 countries. With three manufacturing facilities in North America, Germany and China, 25 wholly owned group companies and 18 distributors Thomas is uniquely positioned to serve cuswww.gd-thomas.com tomers world wide. Company Profile Over 6,500 slip ring sysems for CT’s – every year! Schleifring und Apparatebau GmbH Germany Am Hardtanger 10 82256 Fürstenfeldbruck Tel. +49 8141 403-0 Fax +49 8141 403-45 sales-med@schleifring.de www.schleifring.com Our customers are specialists in complex technical products for the aerospace, energy industry and automation as well as the medical sector. The outstanding quality of our precision products in medical technology is proven and we are constantly setting new standards with our high-tech portfolio. We maintain a global network of sales, service and manufacturing establishments to be close to our customers throughout the world. As market leader SCHLEIFRING meets the complex and demanding requirements for sophisticated electrical rotary joints and slip ring systems for CT scanners throughout the world. These rotary joints ensure the supply of power, the transmission of all bus signals as well as the contactless transmission of digital image data. All SCHLEIFRING slip ring units are all individually customized according to customer specifications by our highly skilled engineering team. We place a high priority on retaining our most precious asset, our knowledge, by developing and producing all components in-house to produce the best results to your full satisfaction. Our service for you: • In-house development and manufacturing • Assembly and testing • Assistance at qualification • Worldwide service support on-site Our highly qualified sales team takes care of your interests and your product from development stage to delivery and beyond. www.schleifring.com 47 MED engineering INTERNATIONAL 2013 Materials Multi-lumen Tubes and Catheters Multi-lumen catheters enable different functions in order to promote less invasive procedures. Whether its development will be a success depends on precise specifications and a trustful communication between designer and manufacturer. multi-lumen catheter can be a critical element to the success of a minimally invasive device. Its fabrication, however, can prove to be a significant challenge. To ensure that the finished, multilumen catheter meets a user’s functional needs, it is important to Contact Helix Medical Europe SE & Co. KG D-67661 Kaiserslautern/ Germany Phone: +49 (0)631 53417500 Fax +49 (0)631 53417600 www.helixmedical.de 1 In order to produce this 9-hole multi-lumen tubing functional requirements and tolerances should be clearly definend and the material to be employed carfully selected MED engineering INTERNATIONAL 2013 define the design, material, and performance requirements as accurately as possible with the available information. Clearly articulating these requirements with knowledgeable material selection and specifying the desired application will provide the optimum successful outcome within the shortest delivery time. Any gaps in information, due to confidentially concerns or key facts that are not available, can greatly impact the material and design selection process. Specifications Well defined that are not accurately defined will specifications most likely lead to elongated program timelines with an associated increase in costs. Spending the time to clearly define the requirements and partnering with a qualified manufacturer who is able to achieve the goals set for the project will save both time and money. As expected, there are numerous configurations available that are based on the requirements of the component tubing and/or finished device. A successful outcome will be accomplished through the communication, imagination, and technical capabilities of the designers and manufacturers. In order to develop and produce a multi-lumen catheter, the genesis is in the specifications for the required tubing. The catheter could be generated from a single or multiple extrusions to achieve the desired result. Other alternate construction techniques may be employed in the “building up” of individual layers of materials and tubing. This complex extrusion incorporates diverse materials not chemically compatible, such as braid/coil reinforcement, PTFE liners.The following information outlines considerations that, when taken into account before manufacturing, lead to a functional and cost effective outcome for the medical device customer. Biomaterial selection – any material, surface, or construct that interacts with biological systems: Biocompatibility – consider anatomical areas of use and length of time in contact with the body Hardness – single or multiple combinations of materials with different hardness along the shaft, measured in durometer, affect compressibility, column strength, kinking, stretch 48 © Carl Hanser Verlag, Munich All photos: Helix Medical Europe SE & Co. KG The Way to Perfect Catheters A Temperature sensitivity – What impact will temperature have on the performance of the catheter? Sterilization – the method of sterilization will have a critical bearing on the materials used and the packaging concepts employed 2 When selecting the biomaterial for endoscope catheters biocompatibility or the sterilization method have a great influence Mechanical requirements – acceleration and deformation (both elastic and plastic) of devices/components under known forces or stress: Torque – rotation of the catheter about its axis (twist) Ability to push or advance tubing – a determined advance against opposition; column strength (the ability to advance a catheter within body structures or catheter guides) Kink Resistance – maintaining the inner bore diameter over a specified bend radius (resistance to collapse) Functional requirements – fulfilling the purpose of the device or component: Co-efficient of friction of the outer/inner lumens – incorporating PTFE or FEP liners to provide a lower co-efficient of friction in order to deploy or pass a device through one of the inner lumens with ease Bend radius – incorporating spiral coils to achieve the required bend radii and maintain the inner bore diameter (kink prevention) Steering – the steering wires may be incorporated into the smaller lumens. Steering capability allows the operator directional control at the distal end of the catheter Braid/coil construction (for reinforcement of the tubing) Varying diameters (inner or outer) Incorporation of additional components (e.g., hypo-tubing, wires, electrical conductors, and marker-bands) Material stack-up for reinforced catheters – the outer jacket must have enough coverage (i.e., wall thickness) to ensure that there are no exposed wires, or that the surface of the catheter will not be compromised due to manipulation of the catheter during the procedure Construction – the translation of design into reality: Varying flexibility (incorporation of different material durometers) Tolerance – permissible limit(s) of variation in devices/components: The tolerance specification Experienced manufacturers assure high quality Optical Components s#ONlGURABLE$IGITAL-ICROSCOPES s(IGH-AGNIlCATION#-OUNT/BJECTIVES s4ELECENTRIC,ENSES Solutions in Optics - Reduced to your Needs www.opto.de 49 MED engineering INTERNATIONAL 2013 Materials Multi-lumen Tubes and Catheters Controlling a pain management catheter precisely e.g. in the spine area is of great importance. Incorporating steering wires has to be considered carefully in design to ensure this functionality must be functional and manufacturable Too tight a tolerance – does not allow for variation, which is evident in complex parts Too great a tolerance – accessories (i.e., handles) will not have an adequate fit to the part Mutual communication @ MG110027 www.med-eng.de Validation – confirming that the medical product/component meets the needs of its users: The key component for accurate, repeatable catheter construction is attributed to quality extrusion capabilities together with robust validated processes. Validation of extrusion is a difficult task, even for simple single-lumen tubing. The introduction of ultrasonic capabilities has made it possible to verify the product rather than validate the process itself. It is possible to verify OD, ID, concentricity, ovality and wall thickness 100 percent of the time. However, ultrasonic verification does not work for all of the attributes of multi-lumen tubing. Therefore, the traditional validation process needs to be carefully considered. When considering the validation of a multi-lumen tube, careful attention should be paid to the following: Functional requirements of the product need to be considered in order to prevent over-engineering that may lead to manufacturing and validation difficulties Tolerances involved are tied to the specific materials used to produce the catheter. When specific Cpk values are required, it is MED engineering INTERNATIONAL 2013 necessary to pay very close attention to specifications and tolerances. As less invasive medical procedures utilizing smaller catheters have entered the market, extrusion tolerances have become tighter and tighter, leading to challenging validation processes dimensional specifications are critical and need to be considered. For example, wall thickness is usually stated with ±tolerances. It may be perfectly acceptable to only set a minimum specification on the wall thickness, rather than having a two-sided tolerance materials employed need to be deliberated when discussing validation. Softer materials and thin-walled materials are much more difficult to manufacture and, therefore, more difficult to validate As with most medical devices, the route taken for validation of a multi-lumen tube should consider the IQ, OQ, and PQ processes. When it comes to validation of extrusion, the process can be carried out in a slightly different format. The OQ process can be avoided, going from IQ straight to PQ verification runs. The reason is that extrusion tends to run in a closed-loop control process, where the dimensional inspection readings of the OD (taken from SPC software) are used to feed information back to the extruder, thereby making continual adjustments of the processing parameters of the extruder. This ensures that the dimensional specifications of the product are maintained 100 percent of the time. Thus the requirement of an OQ is not deemed necessary. The key components for accurate repeatable catheter construction are attributed to excellent communication; acceptance of requirements and specifications; and repeatable, quality extrusion capabilities – all together with robust validated processes. A distinct advantage for developing complex catheter devices is realized when the provider has the key knowledge, process capabilities, and resources in-house to facilitate rapid project turnaround, in addition to meeting all quality requirements and providing the customer an attractive and acceptable cost/value ratio. Helix Medical Europe provides tailor-made catheters for sophisticated applications in cooperation with its Irish partner companies Vistamed and Cambus Medical – all part of the Freudenberg Group. Furthermore is Helix Medical a one-stop-shop for medical components, produces tubing and precision moulded parts of silicone and thermoplastics in clean room production in its German facility in Kaiserslautern. Those products can be upgraded to customized solution packages by additional features such as surface coatings and treatments or pad printing, tip trimming and precisioncut-to-length. Linda Maher is development engineer at the Helix Medical subsidiary enterprise Vistamed Ltd. in Carrick-on-Shannon, Ireland. Imaher@vistamed.net 50 © Carl Hanser Verlag, Munich Photo: Helix Medical Europe SE & Co. KG 3 New Product Optical Diffusers Continuous diffusion adjustment Edmund Optics announces the release of its new electronically variable optical diffusers. These versatile diffusers are fully tunable and offer excellent flexibility for a wide range of integration solutions. These electronically variable optical diffusers utilize a liquid crystal film to vary the degree of optical diffusivity from near-Lambertian to clear. The diffusion angle can be continuously adjusted using a convenient control knob. Diffusion angles (FWHM) range from 1° in the clear state to 70° in the fully diffused state. The diffusers feature a spectral range of 400 to 1500 nm, a 25 mm aperture, transmission of 85 percent and a fast response time of 10 to 20 ms. Featuring C-Mount mounting threads, the electronically variable optical diffusers are compatible with Edmund Optics' full range of C-Mount components, facilitating integration with additional optics illumination, and sensors. Electronically variable optical diffusers are designed to replace a full lab of diffusers, excellent for research and prototyping uses. For example, during the prototype phase, the user can tune to the diffuser needed for the given application and then purchase a diffuser with those specifi- cations for the final OEM application. Gregory Fales, Product Manager, Edmund Optics, explains: »Electronically variable optical diffusers feature a simple user interface and the diffuser's adaptability allows the user to tune to the customer's specific needs, making this an ideal choice for taking an optical system from design to prototype to production.« These electronically variable optical diffusers are ideally suited for applications including biophotonics research, holography, neutral density filtering, preventing oversaturation of detectors or optically characterizing materials. The diffusers are in-stock and available for immediate delivery for fast turnaround and excellent value. www.edmundoptics.com Company Profile Imaging for Medicine - a life-saving technology! STEMMER IMAGING GmbH Germany Gutenbergstr. 9–13 82178 Puchheim Phone +49 89 80902-0 info@stemmer-imaging.de www.stemmer-imaging.com Having the right perspective in medicine means being able to diagnose illnesses earlier, to improve treatments or even save lives. Modern medicine depends on imaging for the diagnosis and real-time monitoring of operative procedures. STEMMER IMAGING provides the right technology for it. therefore is to install all of these image sources in the hospital environment, to hold different cable concepts for this, to operate the cameras, to transport the image and video data, to display, document and archive the image data, or also to make the images visible for remote diagnostics. In medicine there is a wide range of medical imaging equipment, such as Endoscopes, microscopes, X-ray, CT scans, MRIs or operating room monitoring cameras. These image sources use different interfaces, resolutions, video standards, control options etc. A major challenge This is exactly where STEMMER IMAGING comes in with newly developed concepts and products, e.g. the "Medical Video Server" that can acquire, manage and display any standard image or video source and distribute the data via LAN / WAN, or with small, modular interface modules for GigE cameras often used in surgical lights or as surveillance cameras in operating rooms. Apart from that, STEMMER IMAGING offers many other products for image acquisition, image processing and archiving. As Europe´s largest technology provider for image processing, STEMMER IMAGING is your ideal partner for image processing in medicine. Imaging is our passion. www.stemmer-imaging.com 51 MED engineering INTERNATIONAL 2013 Materials Carbon Fibre Reinforced Polymers 1 Example of a radiolucent CFK targeting device in hybrid design 2 The individual parts of this radiolucent clamp were realized from different PEEK semi-finished products with varying fiber content and design according to their particular requirements In contrast to surgical metal instruments, instruments made of carbon fibre reinforced polymers are radiolucent. To switch from metal to CFRP requires an experienced partner in engineering and manufacturing. a composite of fibers and a high temperature polymer which urgical instruments made of carbon fiber reinforced polyserves as a matrix material. The embedded fibers in the matrix mers (CFRPs) are highly appreciated due to their interesting determine the mechanical properties of CFRPs with regard to strength to weight ratio in comparison to metals. With the fiber quality, length, orientation and percentaged content. use of medical imaging, the most important advantage is radioluShort fibers within composites are mostly non-orientated. Higher cency, or to be more precise, free of artifacts. Other important strength can be achieved by the use of long fiber CFPRs. The long properties are chemical resistance against disinfectants, autofibers may be orientated in the shape of a knitted fabric or plane clavable by moist heat as well a haptic and attractive optical apby plane in a parallel alignment in a composite. pearance. The preferred matrix material is polyetheretherThe requirements of surgical instruments are ketone (PEEK). However, Gsell Medical Plastics demanding. Material and design are chalContact offers proved and tested alternatives for matrix lenged by the repeated use in surgery in terms Gsell Medical Plastics AG materials as well. Furthermore, thermoset epoxy of mechanical forces and hot steam sterilizaPhone: +41 (0)56 6754040 matrixes are available if lower requirements are tion. Strength, durability and dimensional staE-mail: info@gsell.ch needed in terms of hot steam sterilization and bility are indispensable. The requirements of www.gsell.ch biocompatibility. these radiolucent instruments are fulfilled by MED engineering INTERNATIONAL 2013 52 © Carl Hanser Verlag, Munich All photos: Gsell Medical Plastics AG Surgical CFRP Instruments: More than Radiolucent S Material suppliers normally process matrix materials and short fibers to resins, while long fibers are processed to so-called prepregs. Resins are further converted by injection molding or extrusion. On the other hand, prepregs are wrapped around frames, layer-wise pressed into forms or processed to plates with a thickness of up to approx. 50 mm. The fiber content may be up to 50 volume percentage and beyond. The proof of biocompatibility is essential for the later use of these semi-finished products in surgical instruments which may come into contact with injured skin, tissue or bone. The international standard ISO 10993-1 preferred determines the scope of testing. The processing of semi-finished Long fibre CFRPs products is challenging due to the high hardness of carbon fibers increase strength which are embedded in a matrix. Near net shapes are cut by water jet out of compressed plates for further machining to instrument components. Due to an intense collaboration between tool and machine suppliers and our own CFRP production department, significant progress has been achieved in recent years. It allows Gsell Medical Plastics to economically machine with high feed motion and best surface quality. This also applies to circumferential radii, rounding offs and 3D geometries which dominated manufacturing costs in the past. Short fiber reinforced thermoplastics may be processed by injection molding to finished parts, to blanks or to near-net-shapes for further processing. Fiber orientation can be varied in certain limits according to part and tooling design as well as process conditions which have an influence on the mechanical part properties. An appropriate part design is required for each fiber reinforced material involved. OEM suppliers should be integrated in the design process as early as possible. It allows taking care of technical and economic aspects without having to impair the functionality of instruments. Design changes are generally necessary if metal instruments are replaced by CFRP instruments. Multi-layer plates achieve the excellent material strength values Tensible strength only in one plane for example. Delamination of the layer composition of 1800 MPa may be caused by lateral stress. When possible, long fiber reinforced material is preferred in use for more complex and larger geometries. The higher fiber content already reduces deformation of the component during manufacturing as well as in later operation. The orientation of long fibers within the matrix should follow the force path to accommodate highest requirements. By doing so, tensile strengths of over 1800 MPa may be achieved. It is not always possible to manufacture radiolucent instruments without metal parts. They are therefore built in hybrid design. In the so-called targeting devices in traumatology (Figure 1), metal parts acting as drilling gauges have to be precisely loaded and incorporated into the capable device. Multi-part instruments need to be dismountable for the adjacent cleaning process after use in surgery. Metal locking elements or thread inserts reduce excessive wear which might have an impact on function and precision of targeting devices. Beyond plastic metal hybrid design, different 53 3 In comparison to metal materials, FRPs are well suited for external fixation devices with regard to their mechanical properties, radiolucency, and sterilizability plastic components may also be used in one assembly in terms of PEEK , PEEK with carbon long fibers, and PEEK with carbon short fibers (Figure 2). It is always important to evaluate the individual specifications of each component to determine the optimum performance to price ratio. CFRP products are in versatile use in medical technology. Radiolucent targeting devices (Figure 1) enable the precise insertion and fixation of intramedullary nails using Little weight and medical imaging. Furthermore, CFRP retractors are in use in surgehigh elasticity ry. CFRPs can not only be found in surgical instruments but also in other medical applications. As well as weight reduction and good mechanical properties, radiolucency is the main advantage when using CFRPs for external fracture stabilization fixators (Figure 3). Thereby, X-ray imaging allows observation of the consolidation of bone fracture without X-ray shadows which might complicate or prevent imaging interpretation. Weight reduction and elasticity decide on the use of CFRPs for artificial legs. With the given radiolucency, CFR PEEK also used in use for implants, such as spine cages and osteosynthesis plates, thanks to biocompatibility and to interesting mechanical properties of this material [1]. Further applications can be found in surgical navigation systems and radiotherapy devices. Even the most robust device is subject to mechanical wear and there is a possibility it may get damaged. A factory based maintenance service by the OEM suppliers allows cost-efficient provision of refurbished instruments again with in a short turn-around time. This service completes the services of Gsell Medical Plastics. The company has been a dedicated partner for CFRP instruments machining for many years. Literature: [1] Roland Wieling: CFK fibre reinforced PEEK medical implants. European Cells and Materials Vol. 16. Suppl. 2, 2008: 8 Tilo Callenbach is Managing Director at Gsell Medical Plastics in Muri, Switzerland. Patrick Fässler is Sales Engineer at Gsell Medical Plastics in Muri, Switzerland. MG110026 www.med-eng.de @ MED engineering INTERNATIONAL 2013 Materials Plastic Couplings Plastic couplings do not only guarantee a save connection at room temperature but also at high temperatures in autoclaves or at very low temperatures in cryotherapy. Plastic Couplings are a Safe Bet 1 Non-spill couplings guarantee a completely nonspill work environment D Quick and easy connections uring regular maintenance or assembly of spare parts you may find tubing connections that require frequent line disconnections and connections. These processes can be made safer, easier and more efficient by specifying quick connect/disconnect couplings. A large number of factors can influence the choice of the right coupling if you take into consideration the broad range of different coupling types currently available. With the right solution, the result will be a leak free connection and a tight seal that guarantees a secure connection and disconnection. This in turn helps ensure that the user does not come in- MED engineering INTERNATIONAL 2013 to contact with the media, that the tools are protected and that the production processes can be optimized. But not every coupling automatically guarantees a completely nonspill work (Figure 1) environment. And it is this functionality in a quick-disconnect coupling that creates a work-space where the spillage of fluids – and the time spent cleaning up from them – is eliminated. In this way, users benefit from a higher level of protection against the risk of contamination due to leaks or spills. The different types of couplings can be defined by the market applications they serve with different couplings for industrial, medical and chemical applications. In Life Sciences connectors for reusable and disposable connections are used in blood pressure monitoring, surgical, dialysis and patient therapy devices. In the singleuse technology you will find connections between flexible bag systems, tube assemblies, bioreactors and other bioprocessing equipment. The trend leans towards the requirement for quick and easy connections, which can easily influence the design of a coupling and its closure mechanism. Most couplings in the Colder Products 54 © Carl Hanser Verlag, Munich Contact Colder Products Company GmbH D-55252 Mainz-Kastel/Germany Phone: +49 (0)6134 28780 Fax +49 (0)6134 2878-28 www.colder.com All photos: Colder Products Company GmbH Company series feature a thumb latch design. This is a solid mechanism that allows an easy connection and disconnection with one hand. Another closure mechanism, a flexible plastic latch design – featured with the SRC series – can disconnect a coupling upon slight pressure. The twist-to-connect option (i.e. SMC series) is absolutely secure when connected and allows a disconnection with a twist. Plastic material The BreakAway Design of a quick reduces weight disconnect allows a quick and automatic break of the connection – when needed – without depressing a latching mechanism. In the past, this type of disconnection was only seen in metal couplings, but it has been successfully implemented in plastic through Colder’s long industry experience. Past experience has shown that plastic is a very reliable material allowing a cleaner, faster, safer, and smarter way to make reliable connections. With the introduction of plastic quick disconnect couplings more than 30 years ago Colder has proved that plastic is a reliable and suitable material for this market segment. Nevertheless some applications still specify a robust material, like metal, because of its strength and performance. There still remains the perception that metal is more durable than plastic, especially at cold temperatures, but modern plastics can now withstand heavy impact, even in extreme cold. Across many industries, there is crowning recognition of the importance of plastic. This was first seen in the aerospace industry, and today plastics are widely used in the automotive industry as well, primarily on chasses but also in the support frames for engines and transmission systems. When using plastics, reductions of as much as 50 percent in cost, and 70 percent in weight, can be achieved. At the same time, plastic also offers increased flexibility, which in turn impacts the functionality of a product. In every situation, manufacturers must ensure that any changes or improvements in design, material use, or functionality directly correlate to an increased value for the customer. Standard plastic materials, such as polypropylene, offer resistance to environmental stress cracking and can be exposed to challenging environments. Technical plastics, such as Polyoxymethylene (POM), exhibit high strength and rigidity over a broad temperature range, are low-wearing, and are strong enough to withstand the stresses of repeated use. High performance thermoplastic materials, such as polysulfone, have excellent strength good chemical resistance and can better withstand repeated sterilization and higher temperatures than other thermoplastics. Lightweight and high-strength reinforced plastics can be molded into practically any desired form and the properties of the material can be accu- 55 2 Six different media can be transported in these multi-tubing connector, coupling six different lines rately adapted to the required specifications. Glass-reinforced plastics, for example, are extremely strong and durable, increasing the safety of the final product. An important step within the selection process is to determine the correct O-ring material. Depending on the application specifications, some materials can offer higher chemical resistance while others have better heat resistance or flexibility at lower temperatures. In the medical device industry quick disconnect couplings can be of service as an attachment to tubing, in a medical device or on the outside of such a device. Many medical devices designs feature connections for fluids or air RFID for a on the backside or within the device. In these cases the functionasave connection lity is more important than form and appearance. If a device has to integrate more than one connector then multitubing connectors (Figure 2) are the best choice. Colder offers standard connector options for two, six and ten lines that allow the connection of several tubing lines and the transportation of different media within a single connector. If there are connections that require the integration of fluid and electronics, Colder’s Hybrid Connector can be the best choice. This connector integrates fluidics and electronics into a single connection point. It eliminates the need for multiple connections and simplifies the user interface between remote tools and a device. Medical professionals can quickly change or replace modular tools, umbilicals or hand pieces that require power, signal, air or fluids in a wide range of medical device applications. Another option that offers more functionality is the integration of RFID (Figure 3) in quick coupling systems. The unique MED engineering INTERNATIONAL 2013 Materials Plastic Couplings @ MG110020 www.med-eng.de IdentiQuik Smart coupling innovation integrates RFID technology into couplings and package closures or inserts. Before the final connection of the body and insert is made, the IdentiQuik automatically exchanges product data to control the connection and the process. These couplings series protect brand integrity, improve safety and help realize significant cost savings. But an RFID solution is not always needed if there are other options – like color or mechanical coding – that can support the application better. On the one hand color coded connections, such as the series 4 and 6 Non-Spill couplings, are offered in different colors and can ensure that misconnections are avoided. In addition the soft touch overmold provides an easy grip and a pleasant handling experience. On the other hand mechanical coding can help the user to always make the right connection as this solution prevents mismatched connections due to keyed parts. These provide foolproof connections for non-interchangeable lines. Established and proven technology can be presented in a new look if a user needs more than just a “part” and is instead looking for an overall solution. Colders engineered solutions team is able to design application-specific options that solve customers’ problems and offer improved product performance. During this process, Colder is able to identify, and implement, the latest trends in the medical market. Many manufacturers of medical devices rely on Colder’s quick disconnect couplings and fittings to provide secure connections and disconnections for a broad range of applications. Colder couplings allow autoclaves to drain easily. These devices are used to sterilize equipment and supplies by subjecting them to high pressure saturated steam at 121°C for around 15 till 20 minutes depending on the size of the load and the contents. You will also find Colder quick disconnects on endoscope reprocessing machines. While the use of these high-cost devices has become more routine, the cleaning and disinfection procedures involved with reprocessing the equipment can be challenging. These coupling products provide a leak-free connection between internal endoscope channels and endoscope washing devices during the disinfection process. Another interesting device, which helps to reduce pain before a surgery and to accelerate the healing process after an operation, is cryotherapy, which is the local or general use of low temperatures in medical therapy. Colder has designed a custom solution that integrates two non-spill coupling sets into one connection component. During that cooperative process, Colder developed a plastic housing that integrates plastic couplings with RFID and nonspill functionalities, creating an easy to use connection module for this type of treatment device. This gives medical personnel better control and increased security during the treatment. The integrated RFID technology avoids misconnections, identifies fluid characteristics and captures a lot of connection, patient and treatment data. Implementing two non-spill couplings into one housing MED engineering INTERNATIONAL 2013 3 In couplings, package closures or inserts with integrated RFID technology, product data are exchanged and wrong connections are avoided allows the manufacturer to reduce assembly time and provides an easy to use and lightweight device – both important targets for the customer. These medical application fields use standard couplings but specifically designed custom solutions as well. Custom-designed couplings might be extremely important for OEM applications where the efficient integration of an OEM product is key. Due to the close cooperation between supplier and manufacturer, Colder has built up a strong bank of expertise in the manufacture of high quality custom solutions. Working with customers help to create connection solutions that are specifically designed for their needs and reflect the individual product requirements. Ingo Mohr is application engineer at Colder Products Company in Mainz, Germany. Ingo.Mohr@colder.com 56 © Carl Hanser Verlag, Munich Company Profile RECOM Electronic GmbH Reinforced DC/DC Converters with 3rd Edition IEC-60601 Recom Electronic GmbH Germany Carl-Ulrich-Str. 4 63263 Neu-Isenburg Tel. +49 6102 88381-0 Fax +49 6102 88381-62 info@recom-electronic.com www.recom-electronic.com RECOM offers a wide range of DC/DC converters that are certified to the stringent requirements of the IEC/EN 60601 – Medical Equipment standard. ISO-14971 Risk Management files have been completed, which are necessary for the successful certification of the final product. The product portfolio includes fully certified DC/DC converters with a power range from 0,25W up to 15W. For example the RAM (1W, unregulated), RAZ (1W, regulated) and RTM (2W, unregulated) series, offer an isolation voltage up Company Profile to 4kVDC and an operating temperature range up to 100°C. For higher wattages the regulated converters of the series REC10 (10W) and REC15 (15W) are suitable. They achieve efficiency up to 87% and can be used in ambient temperatures of between -55°C and +71°C. The “/R” series have a specially designed reinforced isolation transformer core and new insulation materials to ensure that not only the 3rd Edition of IEC-60601 required clearance and creepage distances are observed, but also higher isolation voltages of up to 10kVDC can be guaranteed. The reinforced isolation series meet the highest safety category and have two safeguards for the protection of patients (2 x MOPP – means of patient protection). The RxxPxx/R and RxxP2xx/R series (1W and 2W respectively) are isolated up to 8kVDC and available in a space-saving SIP7 case size. The 2 watt version is also available in a DIP24 case (RV series), making a changeover to the new technology simple without requiring a new PCB layout in many cases. The REC3.5 and REC6 series have 3.5 and 6W power rating, are isolated up to 10kVDC and come in a standard DIP24 case. For all RECOM 3rd Edition Medical converters the 57 Driven by Innovation & Quality As a partner to a wide variety of industries, our product range is synonymous with reliable highquality solutions in the range of 0.25 to 60 watt, either with AC or DC input. Decades of experience in power supply have given us an excellent position to supply innovative products with cutting-edge circuit topology and state-of-the-art components which meet every safety standard, as our certificates show. Quality takes top priority along with innovation at RECOM, quality that we guarantee in our in-house quality assurance laboratory; all of our products come with a three-year or five-year guarantee. Sales, Service & Technical Support Worldwide We've risen to the global challenge in a product range with service excellence and technical support available almost anywhere in the world. We have a worldwide distribution network that leaves virtually nothing to be desired – whether internationally active distributors or regionally specialised partners. Give us a try! www.recom-electronic.com MED engineering INTERNATIONAL 2013 Index / Masthead Advertisers / Index Advertisers apra-plast KunststoffgehäuseSysteme GmbH, Daun-Pützborn 15 Bicker Elektronik GmbH, Donauwörth 37 Bühler Motor GmbH, Nürnberg 21 CIM med GmbH, München 19 Comité EPMT/EPMT 9 EBV Elektronik GmbH, Poing 2 Faulhaber GmbH & Co.KG, Dr. Fritz, Schönaich 60 Gardner Denver Thomas GmbH, Puchheim 47 Hanser Verlag, München 59 Helmut Klingel GmbH, Pforzheim 27 KNF Neuberger GmbH, Freiburg 29 Kontron Embedded Modules GmbH, Deggendorf 45 Maxon Motor AG, Sachseln/CH front cover Micro-Epsilon, Ortenburg 5 MSC Vertriebs GmbH, Neufahrn 3 Novoplast GmbH, Halberstadt 41 Opto Sonderbedarf GmbH, Gräfelfing 49 Panasonic Electric Works Europe AG, Holzkirchen 11, 31 Physik Instrumente GmbH & Co.KG, Karlsruhe 7 RECOM Elecrtonic GmbH, Neu-Isenburg 57 Schleifring und Apparatebau GmbH, Fürstenfeldbruck 47 Stemmer Imaging GmbH, Puchheim 51 Steute Schaltgeräte GmbH & Co. KG, Löhne between page 34+35 STM Sensor Technologie München GmbH, Neubiberg 13 Index A. Hopf Awaiba Baumer Group Bayer HealthCare Biofluidix C IM med Colder Products COMPAMED Compumedics DWL congatec dSPACE Eastman Chemical Edmund Optics Electronic Assembly ELTRA Fischer Connectors Fraunhofer IOF 46 8 29 7 22 40 54 8 35 27 43 46 51 26 18 40 8 Fraunhofer IZM Fujitsu Technology Gsell Medical Plastics Helix Medical HOERBIGER Micro Fluid ITT Cannon KNF Neuberger Leoni LINAK Maquet maxon motor MEDICA Messe Düsseldorf Micro-Epsilon MSC Vertriebs GmbH NuSil Technology Ottobock Pantec Engineering Parker Hannifin PEWATRON Physik Instrumente (PI) Proto Labs Protomold Radimetrics Reichelt Chemietechnik Richard Wolf Sensirion SKF Sony DADC Steinbeis Transfer Centre for Plastics 8 35 53 50 40 26 40 41 19 11 39 8 8 17 30 46 38 34 19 18 23 25 25 7 46 11 18 18 6 6 steute Schaltgeräte Swiss Medical Cluster Texas Instruments (TI) TQ-Systems TTP Vistamed Watlow World Medtech Forum Zellwerk 13 6 31 37 26 50 6 6 24 Authors Arnold Steffen Becker Guido Cabell Peter Callenbach Tilo Diepenbrock Stefan Eisenbarth Wolfgang Fässler Patrick Gerold Widenhorn Hoffmeister Hans Hoser Peter Huber Lorenzo Krob Doreen Lillwitz Sonja Löffler Thomas Maher Linda Mausolf Rainer Mohr Ingo Salzberger Johann Schuetz Anja 23 15 37 53 29 32 53 35 24 35 34 45 45 25 50 24 56 17 39 Masthead Short description MED engineering is the trade journal for designers and developers of diagnosis and therapeutical devices for all medical fields, including ophthalmology, ENT and dental medicine as well as for laboratory diagnostics and OR technology. It provides valuable information in order to export medical devices. The topics focused on are medical electronics, hardware and software device components as well as materials, relevant for the device development as well as the development of endo- and exo-prostheses. Information on metrology and software tools support the developers in their daily work. Editor-in-Chief Erika Fuchs Kolbergerstraße 22, 81679 München / Germany Phone +49 89 99830-626 Gabriele Wieser (Assistant) Phone +49 89 99830-231 Fax +49 89 99830-126 Advisory Board Rainer Birkenbach, BrainLAB; Prof. Dr. Armin Bolz, Corscience; Kurt Eggmann, Weidmann Plastics; MED engineering INTERNATIONAL 2013 Prof. Dr.-Ing. Petra Friedrich, University in Kempten, Germany; Theodor Lutze, Aesculap; Prof. Dr. Peter Schaff, TÜV SÜD; Dr. Timo Schirmer, GE Healthcare; Sigrid Uhlemann, DQS Medizinprodukte; Prof. Dr. Dr. Erich Wintermantel, University in Munich (TUM), Germany Publisher Carl Hanser Verlag GmbH & Co. KG Kolbergerstraße 22, 81679 München Postfach 86 04 20 D-81631 München / Germany Phone +49 89 998300 Fax +49 89 9848-09 www.hanser.de, ISSN 2190-8788 www.med-eng.de In accordance with §8 of the Bavarian Press Act, we herewith state the ownership structure as follows: Carl Hanser Verlag GmbH & Co. KG, Kolbergerstr. 22, D-81679 Munich, seat and registry court: Munich HRA 49621, Shareholders: Carl Hanser Verlagsleitungsges. mbH, Kolbergerstr. 22, D-81679 Munich, seat and registry court: Munich HRB 40463; Ruth Beisler, housewife, Munich; Gertraud Bracker, book seller, Weilheim; Wolfgang Beisler, managing director, Munich; Ulrike Beisler, publisher, Rome; Christoph Beisler, artist, Munich. Managing Directors Wolfgang Beisler, Stephan D. Joß, Michael Krüger Advertisement Manager Martin Ricchiuti Phone +49 (0)89 99830-686 Fax +49 89 99830-623 martin.ricchiuti@hanser.de Layout and Production Nina Copp, Phone +49 89 99830-158 Hadrian Zett (Production Manager), Phone +49 89 99830-420 Print APPL, sellier druck GmbH Angerstraße 54, D-85354 Freising Printed in Germany Copyright and Publishing Rights The publication and all individual articles and illustrations contained herein are protected by copyright. Upon an article being accepted for publication, the rights of publication, as well as the rights of translation, of granting reproduction licences, of storage in electronic retrieval systems, of producing special impressions, photocopies and microcopies are transferred to the publi- 58 sher. Any utilization thereof outside the limits of the copyright act is forbidden without the written permission of the publisher. The admission to use articles in digital press reviews or online press reviews is provided by PMG Presse-Monitor GmbH; Phone: +49 30 284930 URL: www.presse-monitor.de Descriptive Names The use of general descriptive names, proprietary names, trade names, commercial designations or the like in this publication in no way implies that such names may be used freely; these are often legally protected, registered trademarks, even if not designated as such. While the advice and information in this journal are believed to be true and accurate at the date of its going to press, neither the authors, the editors, nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher gives no warranty, express or implied, with respect to the material contained herein. © Carl Hanser Verlag, München 2013 © Carl Hanser Verlag, Munich T E C H N I C A L M AG A Z I N E S | T E C H N I C A L BO O K S | O N L I N E S E R V I C E S | S E M I N A R S Lives up to its Promise Now also available as Digital Edition! www.kunststoffe-international.com SO DOES KUNSTSTOFFE INTERNAT IONAL . The English edition of the well-established German magazine K U N S T S TO F F E provides you with approx. 700 pages annually of up-to-date information. Here you can read exclusive articles on materials, processing and application. I N T H E O N L I N E P O R TA L K U N S T S TO F F E - I N T E R N AT I O N A L . C O M you can find not only the online archives in English and German but also our complete range of plastics information. There are three versions of KUNSTSTOFFE INTERNATIONAL: • NEW! 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Dem natürlichen Bewegungsablauf sehr nahe kommend, passen leichte Kleinantriebe in Verbindung mit intelligenter Präzisionssensorik die Prothese an die Gangart des Trägers permanent an. Für diese anspruchsvolle Antriebslösung setzte der Prothesenspezialist Ottobock auf das Know-how von FAULHABER. Weitere Informationen unter www.faulhaber.com/beinprothetik WE CREATE MOTION