2018 - MED-engineering

2018www. med-eng.de/ internat ional

8 Cover StoryTake a Look at Blood with Analysis Machines

WWW. E P H J . C H

12 - 15 JUNE 2018GENEVA PALEXPO

INTERNATIONAL TRADE SHOWHIGH-PRECISION LEADERWATCHMAKING AND JEWELLERY - MICROTECHNOLOGIES – MEDTECH

20,000

PROFESSIONAL VISITORS

OVER

800

EXHIBITORS

www.med-eng.de

Editorial

Carola Tesche, [email protected]

Noquestion, digitalization is no longer avoidable. There-fore, digitalization is the business of everyone who isentitled to decide onmatters of what direction a compa-

ny will have to develop.

Nowadays there is for rather every aspect of digital transforma-tion a wealth of solutions. As a consequence, it is hard to keepanoverview.Oneneed only to think of theuninterrupted transferof a huge amount of data up to a broad automatization. Subse-quently the requirements are more complex and differentiatedthan ever before and continue to pace new demands on manu-facturers and employees as well as on users. At the same timethere are some numerous advantages. For instance, improved

processes and more sophisticated devices along the entire va-lue chain to name just a view.

Thus, those responsible can choose the most suitable system from awide variety. Subject to that condition is unquestionably that they ha-ve clarified upfront what new models the digital transformation iskeeping on hand that fits a company´s special services andmethods.

Associated with the digitalization are fundamental new workpla-ces. Consequently, the requirements towards the staff will changeand grow as well. Currently there is no telling if it will lead altoge-ther to more or less workplaces. Also, there are various people thatwill have difficulties with the high speed of the new requirements.Therefore a sophisticated leadership is essential in order to takealong the employees and to support their individual development.In the end the question arises not so much of technical implemen-tation but rather the acceptance.

Heading for NewShores

We are there when reliability is of top priority.

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Our innovative sensor solutions make medical devices even safer and more efficient.

@ www.med-eng.de/m.med-eng.de

3

MEDengineering INTERNATIONAL 2018 www.med-eng.de

Precision Bearings for PreciseDiagnosisPrecision bearings are used inmanymedical applications – forexample in ahighprecision x-raymachine with C-arm that is usedfor diagnostics purposes inoncology.

Theranostic ImplantsTheranostic implants are com-plex, multifunctional, implan-table medical devices that com-bine therapy and diagnostics inonemedical system. Fraunho-fer-Institute for Integrated Cir-cuits IIS conducts research anddevelopment inmultidisciplina-ry cooperation in this field.

Precise Positioning RequiredElectrically adjustable lifting

columns from RK Rose+Kriegerensure high-precision adjust-ment of the optical system in

DIERS biomechanical measu-ring systems

Contact:Editorial OfficeCarola Tesche(accountable)Phone +49 (0) 9221 949-238Fax +49 (0) 9221 [email protected]

AdvertisingDaniela HöhnPhone + 49 (0) 9221 [email protected]

DistributionStefanie HirschmannPhone +49 (0) 9221 949-311Fax +49 (0) 9221 [email protected]

Mediengruppe Oberfranken –Fachverlage GmbH& Co.KGE.-C.-Baumann-Str. 595326 Kulmbach

www.med-eng.de

Content

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www.med-eng.de

Take a Look at Blood with Analysis MashinesHigh-techmachines analyze human blood samples, detect coagula-tion disorders and thus help to save lives. maxon supplies the appro-priate drives and builds the entire conveyor modules.A peek inside.

maxon motor agmaxonmotor agCH-6072 SachselnPhone + 41 41 666 15 00www.maxonmotor.com

Content

Innovative solutionsfor medical devices from concept to series production> Medical microelectronics

(design service, organic and ceramic substrate manufacturing,

semiconductor packaging, board assembly, test services)

> Batteries and battery packs for active implants

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MST Group. Active around the globe, the Micro Systems Technologies (MST) Group consists of four technology companies with more than 1100 employees in three countries:> DYCONEX AG (CH)> LITRONIK Batterietechnologie GmbH (DE)> Micro Systems Engineering GmbH (DE)> Micro Systems Engineering, Inc. (USA)

www.mst.com

MED Scene

6 Safe digitalization

MED Components

Motion Technology8 Take a Look at Blood with Analysis

Machines12 Less is More16 Electric Actuator of Next

GenerationConnection Technologies20 Magnetic and Self-Mating

Connectors24 Precision Bearings for Precise

DiagnosisCase Technology26 Ball Bearing Slewing Rings in a

C-arm X-ray MachineFluidics28 Measuring Lowest Flow Rates in

Medical TherapiesValves32 Precision and Speed without

Compressed AirPumps34 First Choice for “Third Teeth“Lifting Columns38 Precise Positioning RequiredOptical Components40 Diagnostic Devices to Takeaway

MEDMaterials &Procedures

Construction Materials43 Ecological Alternative to Toxic

Lead45 More Features with Miniaturized

Devices48 Optical Fibers with Long-term

UV-Resistance

MED Devices

Operating Systems50 Medicine for the Medical Field

Positioning Systems53 NewMaterials –NewApplications55 Finding top-level suppliers56 Customised SolutionsImaging Techniques58 Walk WellRobotics60 Robotics is Changing Medicine

MED Electronic

Assemblies/Boards63 Film Capacitors for High-Voltage

ApplicationsMeasurement Technology65 Cool Samples and Ice-Cold

Measurement TechnologyPower Electronics68 Management of GaNMMIC Power

Amplifiers

MED Software

Engineering Tools71 Safe Software Engineering by

Suitable ComponentsData Security73 Protecting the Software in

Medical DevicesSimulation76 Model-Based Development of

Medical Software78 Realistic Simulation of a Human

Heart

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Contract Production79 The Driving Force for Additive

ManufacturingPrototyping & Batch Production81 Wearable Medical Devices83 Antimicrobial coated Keyboards

MED Prothetik

Endo- and Exoprothesis84 Theranostic Implants

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2018www. med-eng.de/ internat ional

8 Cover StoryTake a Look at Blood with Analysis Machines

5


MEDScene Market

Image:System

Industrie

ElectronicGmbH

The technological (r)evolution in laboratories and hospitals and itsdemand for security and data protection

Safe digitalization inmedical engineering

The digitalization is on the rise. Terms like „Industry4.0“, „IoT“ or „digital Factory“, as well as relevantprocesses and success stories from the industrial field

are well known and established. Now the healthcare sectoraims for a similar development.

Markus Dillinger, General Manager – Technology of S.I.E SO-LUTIONS, a development and production specialist within thechallenging fields of Medical Technology and IVD believes: „Acomplete digitalization and extensive automation progress wit-hin the health sector, focussing on reliability, connectivity andsecurity is inevitable. Compared to industrial applications, themedical field obviously works within much more sensitive ope-

ration areas, with correspondent privacy and protection needs.Therefore the development of advanced medical devices al-ways has to go hand in hand with complete security concepts.In addition the risk assessment of those two sectors is comple-tely different. While business-IT sets its focus on security befo-re function,medical devices have to put function before securi-ty.“ Innovative development and production specialists have tointegrate this essential prioritization within the health sectorinto their simulations during the conception of new devices.

The three pillars of security

Up-to-date security concepts are based on the classic „threepillars of security“. Confidentiality – Integrity – Availability.For fully digitizedmedical technology hardware and software,provisions have to be made for each of these pillars. The firststage of establishing a security concept is the so-called „pro-tection target assignment“. In this context product individualquestions have to be fielded: What should be protected? Whyshould it be protected? Who is the potential invader? Talkingabout medical devices, a decided approach is recommended.„Fully digitalmedical devices aremanipulable and vulnerableon several levels.“ says Markus Dillinger. „The operating sys-tem is based on a hardware platform and its bootloader. Eachof these sections could be attacked and has to be protected.“

Security on every level

As a result complete security concepts start on the hardware levelto guarantee permanent availability of the system. (see above:„three pillars of security“). For example robust, ESD-suitable cir-cuit design in excess of normative standards can protect a devicefrom USB high voltage generators. Without protection, these ea-sily obtained USB sticks can deactivate a device. Especially wit-hin the health sector this would cause fatal damage. „Whilst theincreasing connectivity and interfaces will make operational pro-cedures easier and more comfortable, one thing has to be totallyclear: Every additional possible interface makes a system morevulnerable. Therefore, during a product“s development the focushas to lie on particularly secure product design.“ says Dillinger.

Markus Dillinger, General Manager- Technology, System IndustrieElectronic GmbH

6

www.med-eng.de MEDengineering INTERNATIONAL 2018

MEDScene Market

Colder Products Company

Germany Colder Products Company

GmbH Ostring 19

D-63762 Grossostheim Phone: (+49) 6026 9973-0

China Colder Products

Company Limited Flat B, 29/F, West Gate Tower

7 Wing Hong Street, Cheung Sha Wan

Kowloon, Hong Kong Phone: (+85) 2 2987 5272

[email protected] cpcworldwide.com/medical

Choosing the right fluid connector and the right connector company.At CPC we know that fluid connectors need to be considered early in the process in order to fulfill product performance and patient safety objectives.

Because the connector is usually the user’s primary interface with the device, it plays a key role in the overall perception of the design. Well-designed, reliable connectors from CPC make the medical device easy-to-use and enhances the overall satisfaction your customers will have with it.

Cleaner, faster, and saferCPC quick disconnect couplings make medical device connections cleaner, faster and, most important, safer. Whether your application calls for non-valved or non-spill, low flow or high flow, reusable or disposable, our broad range of standard (including a complete line of small-bore connections, fittings, and luers) and custom-engineered components can meet your every specification.

■ Cold/Compression Therapy ■ Dialysis ■ IVD ■ Patient Monitoring ■ Surgical ■ And more

About CPCCPC has more than 400 employees, opera-tions in St. Paul, MN, Germany and China, sales offices in ten countries and more than 200 distributor partners around the globe. CPC has produced over 10,500 custom and standard products to meet fluid handling challenges worldwide.

Company Profile

After the topic of system integrity has been addressed, decisi-ons about who can edit data, in which way and traceability ha-ve tobemade.Classic encryption solutions, especialy systemslike secure boots which prevent access and manipulation du-ring the boot stage, are very effective. Secure Boots constrainevery hardware and software component in service to authen-ticate. In case this authentification fails then the system refu-ses access. Also hardware tools, e.g. body intrusion preventi-on or detection combined with correspondently reacting auto-matics like file deletion or device shutoff can help to protectsensitive data.

Of course the third pillar – confidentiality – is part of a comple-te security concept. Aside from internet and intranet connec-tions, the USB port is one of the main soft spots of unsecureddevices.

The secure boot systemsmentioned above aswell as an integra-tedUSBdevice authentification help to solve this easily and ef-fecitively. Markus Dillinger adds: „Especially at the end custo-mer level the most important point is awareness. Who can ac-cess a device, when and how? Do we have well-known updateconcepts? Are our devices protected from unauthorized ac-cess? Togetherwith our partnerswe consistently recognize, thatdetailed training of service staff and the definition of unitaryservice procedures are extremely important steps towards a so-

phisticated security concept. It is important to make oneselfand partners aware of the fact system security does not startwith the topics software or virus protection, but a lot earlier.“

Considering these approaches and concept structures it be-gins to show, why the health sector is still not on level with in-dustry or business IT when it comes to digitization. More sen-sitive data, a more important focus on product reliability aswell as a need for complex security concepts pose many chal-lenges to developers, producers and endusers. But it is clearlyvisible that developers, service providers and their respectivepartner networks are working on new solutions – the (r)evoluti-on within the medical sector towards a fully connected, auto-mated and digitized health care is underway!

CONTACT

System Industrie ElectronicGmbHMillennium Park 12A-6890 LustenauPhone_+43 55 77 89 90 0www.sie.at

7


MEDComponents Motion Technology

Image:©Stago

containers. The machineworks autonomously,checks the results,compares them andmonitors the proces-ses. This saves the bio-logists and techniciansa lot of time. The-refore, the deviceis particularlysuitable for labo-ratories with alarge sample volume.

Precision on Three Axes

StarMax was introduced to themarket in late 2014. Yet Stagodeveloped its first analysis device with an X-Y-Z-axis robot asearly as 1991. Even back then, mdp, maxon motor“s salescompany in France, was on board. Therefore, the drive specia-list was contacted again during the first development phase ofStarMax, to clarify the most important questions: How canprecise movement be achieved on all three axes? How can thereagents be pipetted fully automatically? “In the end, mdpused their vast experience to adapt their standard products tomatch our requirements,“ says Jean-Francois Gelin, ProjectManager Innovation andR&Dat Stago. “Additionallymdpandmaxon contributed their specialized know-how and gave usvaluable tips.“

Easy Motor Control

Thecooperationhasnowbecomesoclose thatmdpassemblesthe complete conveyor system for the pipette racks in its ownproduction facilities in Neyron and ships it to Stago for finalassembly. Various types of the A-max DC motor by maxon areused for themovements of the rack. Thediameters vary betwe-en 16 and 26 millimeter. The DC motors are highly dynamicand easy to control. Additionallymdp installsmatching plane-

High-techmachines analyze humanblood samples, detect coagula-tion disorders and thus help to save lives.maxon supplies the appro-priate drives and builds the entire conveyormodules. A peek inside.

Take a Look at Blood withAnalysis MachinesOurblood is a fascinating fluid. It transports oxygen and

nutrients, fends off foreign objects and closeswounds. At least in normal cases. Some people, howe-

ver, suffer from coagulation disorders. These cases are un-pleasant for the patient and can have severe consequences –or even lead to death. This iswhy early detection of a blooddis-order and the hunt for a cure are so important. This requires alot of testing. Analysis devices in laboratories and hospitalsrun around the clock and are able to autonomously pipettesamples to deliver quick results. Such industrial automationequipment has to work with high accuracy and reliability. Thisplaces high demands on all components and the developers.

Fully Automated Blood Analysis

Stago is a French company that specializes in analysis instru-ments for hemostasis diagnostics, in other words for testingblood clotting. Around 20,000 devices of Stago are in useacross the world – including the StarMax.

This fully automated analysis system is equippedwith a three-axes robot and offers space for 215 samples and 1,000 test

The analysis system STARMax.

8

maxon A-max 22 DCmotor – this brusheddrive with 6W of power offers excellent valuefor money

»

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MEDComponents Motion TechnologyImages:©

maxon

motor

tary gearheads to generate the required torques. The maxonsales company therefore is not only a drive specialist, but alsoan expert in the fields of mechatronics and automation. “Ourcompany slogan –Motors, Systems, Solutions – reflects that,“says Alain Pontille, Managing Director at mdp. “We work very

closely with our custo-mers and jointly create so-lutions that make theirproducts an economicsuccess.“

This worked very well forStago. “When we starteddeveloping hemostasisanalysis machines, hardlyanybody believed in oursuccess,“ says Jean-

François Gelin of Stago. Today the company has more than2,100 employees and delivers its high-end products to morethan 110 countries.

Sales and Parts Production of MaxonMotor

In the fall of 2014, mdp officially became part of the maxonmotor Group. Previously, the company was sales partner forFrance.mdpwas founded in 1982 as provider of micromotorsof variousmanufacturers. The company later grew significant-ly through the sales of standard products that could be ship-ped quickly, as well as by providing a call center for tech-nicalsupport. Today41employeeswork at the headquarters inNey-ron, outside of Lyon – in sales, development and in produc-tion, among other departments. mdp does not only offer itscustomers drives, but instead manufactures complete drive

systems upon request, like in Stago“s case. This makes mdpone of the six global production sites of maxon motor. Theother sites are in Switzerland, Germany, Hungary, the Nether-lands and South Korea.

Author:Stefan Roschi

maxonGP22gearhead – this plane-tary gearhead with a diameter of 22mm provides the necessary torquefor the application.

»»«mdp and maxon contributedtheir specialized knowhow

and gave us valuabletips.«

Jean-François Gelin, Projectmanager atStago

A technician assembles the unit for the medical analysis device.

CONTACT

maxonmotor agBrünigstrasse 220CH-6072 SachselnPhone + 41 41 666 15 00www.maxonmotor.com

10

MEDICAL DISPLAY SOLUTIONS

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solutions for medical industry.



Image:KO

COMOTIONGmbH

Why go for the expensive with too much performance when you cansimply opt for a cost-effective solution that is tailored to your appli-cation?This iswhy the servo system“KannMOTION“wasdeveloped.

Less is MoreAlarge Swiss manufacturer of analytical instruments

had requested KOCO MOTION to develop a drive solu-tion for a large-scale project. The valve-control system

for analytical tools was developed through collaboration bet-ween adlos, who was responsible for development of the con-trol unit, and KOCOMOTION as the drive specialist.

Tomeet the requirements, both companies collaboratively de-veloped a step motor control system that was tailored to therespective application. The collaboration was so smooth, fast,and successful that theManaging Director of KOCOMOTION,Gerhard Kocherscheidt, and the Managing Director of adlos,Thomas Vogt, subsequently concluded a long-term cooperati-on agreement. “We want tomultiply this success concept, be-cause existing products in our portfolio as well as the otherproducts on the market are not ideally suited to meet such re-quirements“, explains Gerhard Kocherscheidt. Thomas Vogtadds: “For us to realise this goal, we plan to modify existinghardware and adapt the software to the needs of the customer.We estimate the development effort required to be between10 and 20 percent depending on the application.“

KOCO MOTION GmbH develops and manufactures small DCmotors, transmission systems, and specialmotors inDauchin-gen, Baden Wuerttemberg. The company consists of a com-plete, 18-member team of exclusive sales partners to theAmerican SEM (formerly known as Intelligent Motion Sys-tems) as well as Constar andDings – a Chinese drive specialistfor step motors, linear actuators, and DCmotors.

adlos AG is based in Liechtenstein and is an independentsupplier of electronicmodules as well as engineering and pro-duction services. The group comprises of three companieswith approximately 200 employees in over 50 countries. Theengineers offered support to the companies in consulting, pro-ject management, analysis, design, implementation, testing,and production.

Three Under One Roof

Simple. Cost-effective. Customer-specific: These are thegoals of the collaboration that is aimed at developing a newdrive platform. With KannMOTION, a new servo system con-sisting of a stepmotor with an integrated encoder and an inbu-ilt control systemwas developed based on the aforementionedcustomer-specific requirements.

“Our KannMOTION system offers our customers competitiveadvantages through the customisation“, Thomas Vogt explainsthe unique selling point of this new development. “And it onlydoes that which it is intended for – perfectly“, he adds merrily:“In terms of quality and features, the systemmatches up to thedrive systems that are currently offered in the Europeanmarketand even goes further to provide a significant cost advantagethrough the inbuilt components that are ideally tailored to theapplication.“ The systems are manufactured in Europe.

Concept of the New Development

First, the cooperation partners realised a cost-benefit calcula-tion in the projects that have already been completed success-fully and those that are still ongoing.

For instance, in terms of the mechanics, a step motor is usedinstead of a DCmotor. This helps save on the components, ac-

The new servo system consisting of a stepmotor with an integratedencoder and a directly attached control unit.

12

»



Images:K

OCO

MOTIONGmbH

companied by less wear, longer service life, and less noise.The pneumatics have also been replaced with a step motorthat has an electronic control unit. The closed loop controltakes over themotor“s speed regulation as well as torque con-trol and positioning.

Compared to pneumatic control systems, KannMOTION al-lows for any kind of driving profiles such as controlled start-upand braking, intermediate positioning, more functionality,longer service life, and lower noise levels with lower operatingand service costs.

Reliable Functionality and Easy Programming

The compact KannMOTION functions reliably as a servo mo-tor and can be programmed via commands or sequence pro-grams. It can be used anywhere where positioning tasks, regu-lated run time, or programmed movement sequences are re-quired. In addition, the onboard digital and analogue inputsand outputs can be programmed to initiate the desired move-ment sequences. KannMOTION is available in flange sizesNEMA 17, 23, and 24 with torques between 0.4 and 3.0 Nm.The supply voltage ranges from 24 V to 48 V depending on theapplication.

Communication is via the standard RS232 interface. Themo-tor parameters are saved in the internal memory. An easy-to-use terminal programenables you to addmore parameters andcommands for desired movement sequences. Operation issimple: All commands can be selected from a drop-down me-nu, with a description of each command displayed on theright-hand side of the screen. TheASCII code alsomakes it ea-sy to program the servo system. This captivating simplicity ofthe terminal programenables the user to realisemovement se-quences relatively fast.

Application Examples with Value Analysis

“Its flexibility makes the KannMOTION concept ideal for awide range of applications, particularly in the industrial field.We have even managed to win over a manufacturer of musicalinstrumentswho nowuses our servo system for vibraphone ad-

justment“, Gerhard Kocherscheidt tells of the productlaunch.

The concept also enabled a 65 percent reduction in costs for arotary heat exchanger through savings on themotor and the re-sultingminimisation ofwear parts. At the same time, thenoiselevels were reduced by 30 percent.

KannMOTION has also been used in an automatic placementmachine where it is designed without a PLC and a control ca-binet, which in turn reduces the sources or error and wear. Anintegrated IO control unit simplifies the cabling. Instead of230VAC, the systemuses24VDCand thus complieswith themachine guideline.

“All this considered, the platform is intended to be as optimalas necessary since we can generate unique features throughthe combination of standard and customisation values. Theabsolute credo is the total cost of ownership (TCO)“, the engi-neering service provider sums up the system“s advantages.

Medium-Sized Centre of Competence

Through the collaboration, adlos and KOCO MOTION havecreated a strong competence centre for KannMOTION wherethe medium-sized flexibility enables almost all customer re-quirements to be addressed conveniently. The engineers arecurrently working on implementation of more interfaces, e.g.CANopen and REST.

“By the way, we are open to all industries and invite the custo-mer to a close cooperation in the new development“, adds the

KannMOTION, a simple drive platform designed for customised applications and only does that which is it is intended for – perfectly and economically.

10 to 20 percent of the development work is in the customer-specificKannMOTION servo system.

14

www.med-eng.de

MEDComponents

drive expert in prospect. Since the optimisation of a drive ora control system always requires corresponding develop-mentwork and, inmost cases, additional tools that result ininitialisation costs, a minimum number of 100 systems isrequired to realise a customer-specific solution. Previousprojects have entailed 1,000 to 10,000 units.

“We are pure idealists“, says Thomas Vogt on future goals.“With our customised KannMOTION systems, we are going torealise high-quality drive solutions whose prices are unbea-table.“ And it also shouldn“t be a problem if you only require asmall number of units: “This is why we have a comprehensivestandard portfolio. Because these are simply more economi-cal for single units and small series“, concludes GerhardKocherscheidt.

The heart of your application.

Healthcare Power Supplies• ACDC, DCDC, EMC/EMI Filters,

standard and modified power solutions

• A recognised market leader

• Over 30 years experience in essential medical applications

• Approved supplier to many top 10 manufacturers

• Global multi-site design, manufacture and local support

TDK-Lambda Germany GmbHwww.de.tdk-lambda.com · +49 (0) 7841 666-0

KannMOTION is used in a rotary heat exchanger and has enabled a 65percent cost reduction.

CONTACT

KOCOMOTION GmbHNiedereschacher Str. 54D-78083 DauchingenPhone +49 7720 995 85 80

www.kocomotion.de



Images:D

yneticsGmbH

The linear Servomotor is a reliable, maintenance and cogging freebrushless servo linear direct drive.

The Electric Actuator ofNext GenerationTheLinearShaftMotor is a highprecisiondirect drive line-

ar servomotor that consists of a shaft of rare Earth-Iron-BoronPermanentNeodymiumMagnets and a “forcer“ of

cylindrically wound coils which can be supplied with optionalHall effect devices. The shaft supplies themagnetic fieldwhichthe forcer acts upon. The forcer assembly, combined with theamplifier and control electronics, produces the force for themotor. The Hall effect devices can be supplied, if they are re-quired by your selected servo driver for proper commutation ofa brushless linear motor, and are integrated into the forcer as-sembly. The Linear Shaft Motor was designed with three basicdesign concepts: - Simple - High Precision - Non Contact –

What is a Linear Shaft Motor?

LinearShaft Motors are simple. They consist of only two parts,a magnetic shaft, and a “forcer“ of cylindrically wound coils.Linear ShaftMotors provide ultra high precision. They have noiron in the forcer or shaft, giving you the precision and zerocogging expected in a coreless design. The coils of the LinearShaftMotor themselves form the core thus giving you the stiff-ness expected in an iron cored motor. Linear Shaft Motors arenon-contact. Since the coil completely wraps around the ma-gnets, all the magnetic flux is efficiently used. This allows for

a large (0.5 to 5 mm) nominal annular air gap. This air gap isnon-critical, meaning there is no variation in force as the gapvaries over the stroke of the device.

Basic Structure of a Linear Shaft Motor

Themagnetic structure of the Shaft is built in such amanner thatthere is no space between eachmagnet and is fully supportedwit-hin itself. Themagnetic structure is then inserted into a protecti-ve stainless steel tube. This is a process which is protected by nu-merouspatents throughout theworld. This patentedprocessusedin the Linear Shaft Motor produces a very strong magnetic fieldwhich is twice that of other linearmotors. Forcer ConstructionThecoils of the Linear Shaft Motor are of a cylindrical design, provi-ding a number of key advantages over other linear motors.

+ The cylindrical design of the coil assembly is very stiff wi-thout external stiffeningmaterials (i.e. iron used by platenstyle linear motors).

+ The coils surrounding the magnets allow for the optimaluse of all the magnetic flux. This makes the air gap non-critical. As long as the forcer does not come in contactwiththe shaft there is no variation in the linear force.

+ The magnetic flux cuts motor windings at right angles formaximum efficiency.

+ All sides of the coil are positioned to allow for maximumdissipation of heat.

+ The more efficient Linear Shaft Motor requires less powerin a more compact design and produces a comparableforce to that of a similarly-sized traditional linear motor.

Features of Linear Shaft Motors

+ Capable of high thrust (up to 100,000 N)

+ Quiet due to the absence of friction, the only mechanicalcontact section is the linear guide. (Fully non-contact ope-ration is possible using an air slider.)

+ Simplified unit construction allows a stroke of up to 4.6metersSingle axis linear table from theSLP series, based on linear servo drives

16



TQ-GROUP Germany

Mühlstrasse 2 Gut Delling

82229 Seefeld Phone +49 8153 9308-0

Fax +49 8153 4223 [email protected] www.tq-group.com

TQ-Group: Your partner for medical technologyAs an electronics service provider (E²MS supplier and CEM) TQ offers the complete range of services from development, through production and service right up to product life cycle management. The services cover assemblies, equipment and systems includ-ing hardware, software and mechanics. Customers can obtain all services from TQ on a modular basis as individual services and also as a complete package according to their individual requirements. Standard products such as finished microcontroller modules (minimodules), drive and automa-tion solutions complete the range of services.

Through the combination of electronics services and finished system components, TQ offers customer-specific products as ODM products and thereby addresses customers who would like to receive finished products and at the same time benefit from the advantages of a customer-specific solution. ODM products are provided on

time and economically using a comprehen-sive solution kit. The kit includes finished electronic, mechanical and software compo-nents including certification and licenses.

Company Profile

+ High precision (0.07nm1)

+ High speed drive (greater than 10 m/s) with accelerationup to 20 G

+ Low speed drive (8μm/s)

+ Allows for parallel drive using only one encoder and onedriver2

+ Virtually no speed fluctuations (±0.006% at 100mm/s)

+ Durable construction, capable of operation even underwa-ter or in a vacuum

Linear Shaft Motor

Traditionally, linear electric motors have been designed by“opening out flat“ their rotary counterparts. Thus, for every ro-tary motor there is a linear motion counterpart, although theopposite of this statementmay not always be true. Thus,corre-sponding to the DC motor and AC induction, stepper and syn-chronous motor, we have the Linear DCMotor (DCLM), LinearInduction Motor (LIM), Linear Pulse Motor LPM), and LinearSynchronous Motor (LSM), respectively. Although this doesprovide a solution, a number of inherent disadvantages arise

Like the voice coil motor, the force velocity (FV) curve of theLinear Shaft Motor is a straight line from peak velocity to peakforce. The Linear Shaft Motor“s FV curves are split into three

regions. Published inNippon Pulse literatureas the ContinuousForce, it is the regionwere the motor can ope-rate indefinitely withouttheneed for any externalcooling,including heatsinks. The second is thepublished AccelerationForce. It is the amountof force which can bedelivered by the motorfor 40 seconds withouttheneed for any externalcooling, including heatsinks. The third region(not published)is limi-

ted only by the power which can be supplied and the duty cy-cle. It is the Peak Force and is limited to 1 to 2 seconds.

Your local Nippon Pulse application engineer can help youmap this for your particular application.The Linear Shaft Mo-tor is a very simple design which consists of a coil assembly(Forcer), which encircles a patented round magnetic shaft.

Linear Servomotor (Spindel and Forcer)

17

»



— —— — — — — — — — — — — — — — — — — — — — — —

This design offers a number of advantages when compared toother types of linear motion systems:

No Need for Precision Air Gap

Unlike other types of linear motor technologies the cylindricaldesign of the Linear Shaft Motor allows for a very large (0.5mm to 5 mm) non-critical air gap. This allows for a constantlinear force, which is not effected by the alignment or misa-lignment of the Forcer (coil) to the Shaft (Magnets). This al-lows for quick and simple assembly into the final product wi-thout the need for extensive machining and alignment time.

High Efficiency

The patented shaft design and resulting magnetic field allowfor an unparalleled magnetic field strength. This allows asmall amount of current to produce large amounts of force.Alongwith the cylindrical designwhich allows for 100%of thecopper, current, and magnetic field to produce force only inthe direction of travel.

Linear ShaftMotors provide direct thrust for the positioning ofthe payload. It eliminates the need for a rotary-to-linear con-version mechanism.

No Lubrication/ Adjustment MaintenanceNecessary

The Linear Shaft Motor requires no greasing, as is necessarywith a ball-screw, and has no performance degradation becau-se of wear/aging as with ball-screw and belt drive systems.Its maintenance-free long lifespan contributes to cost reduc-tion throughout its the life-span. The clearance between theshaft and the forcer eliminates the need for adjustments suchas positioning of the guide or concentric adjustment, whichare all required for ball-screws.

No Noise/No Dust Operation

Dust and noise, inevitable in ball-screw and pneumatic sys-tems, does not exist in the non-contact Linear Shaft Motor.This is not only very applicable for clean room environments,but it also greatly improves the work environment by reducingnoise and dust.

Linear Servo motors in applications:

Two or more forcers can be used on the same shaft to multiplythe thrust. Linear Shaft Motors can be used in parallel; two ormore forcers andtwo shafts connec-ted to the sameload), to achievelarge thrusts for mo-ving heavy objects.

TORQUE LIMITER ECE IN AVERY FLAT DESIGN

Mechanical Torque Limiters are used in all kinds of technical appli-cation areas. Their job is the protection of products and expensive

devices. Torque Limiters react very sensitive to the smallest increase of torqueand disconnect the drive from the following masses in a split second. That“swhy they are also called “Safety Couplings“. The disconnection is forced, thatmeans it has no effect on the function in case of an electrical power outage.A reason for a torque overload is for example the accumulation of material.That“s why torque limiters are also called overload clutches.

The special thing about the Type ECE is the axial short design, which requi-res a very small installation space. This simple and robust functional prin-ciple has thousandfold proved itself. It has a reliable function and still

needs just few parts. High-precision torque limitation is guaranteed withthe use of special disc springs, they also enable a very wide torque rangewithout changing the disc spring.

The perfected functional principle cuts the torquebetween the engine and the machine within fewangle degrees. The couplings have a fixed pointswitching. That means one switching point perturn. That is important to retain the reference pointof the machine.To stop the drive immediately incase of an overload, it is advisable to place a pro-

ximity switch to the disc spring. The disc spring moves while the torquelimiter is disconnecting the drive from the machine. The signal from theproximity switch can be used for the drive control to stop the engine imme-diately. The type ECE has a keyway for the torque transmission betweenengine and torque limiter. www.enemac.org

CONTACT

Dynetics GmbHKlostergasse 6D-41334 Nettetal-KaldenkirchenPhone +49 2157 12 89 90www.dynetics.eu

18


congatec AGGermany

Auwiesenstr. 5D-94469 Deggendorf

Phone +49 991 2700-0Fax +49 991 2700-111

[email protected]

congatec AGcongatec AG has its head of� ce in Deggen-dorf, Germany and is a leading supplier of industrial computer modules using the standard form factors COM Express, Qseven and SMARC as well as single board computers and EDM services. congatec’s products can be used in a variety of indus-tries and applications, such as industrial automation, medical, entertainment, transportation, telecommunication, test & measurement and point-of-sale. Core knowledge and technical know-how in-cludes unique extended BIOS features as well as comprehensive driver and board support packages. Following the design-in phase, customers are given support via extensive product lifecycle management. The company’s products are manufactured by specialist service providers in accor-dance with modern quality standards.

Since the company’s inception in Decem-ber 2004, congatec AG has established itself as a globally recognized expert and reliable partner for embedded computer-on-modules solutions, coupled with excel-lent service and support. We have secured second ranking worldwide in our market segment thanks to our clear focus.

congatec’s COM Express platforms with their widely scalable computing and graph-ics performance enable the creation of application-ready, widely usable products. The quality and durability of the modules, in combination with their excellent EMI characteristics reduce cost of development, service and certi� cation.

Qseven and SMARC modules are even smaller at lower energy consumption. These modules are the perfect � t for next generation ultra-compact and ultra-mobile handheld devices.

congatec is represented with 230 employ-ees at eight branch of� ces on four conti-nents in Taiwan, Japan, China, USA, Australia, Czech Republic, United Kingdom and France. This consistent expansion together with our strong partner network secures close customer relationships on a worldwide base.

We continue to focus on ef� ciency en-hancement through optimizing processes and structures in the future. Through close co-operation with our technology partners Intel, AMD and NXP, congatec continues to prove its leading position in technology and product innovations. In addition to our successful Computer-On-Modules prod-ucts, we also offer a large selection of Single Board Computers and strong Em-bedded Design&Manufacturing Services (EDMS) to ful� ll the special requirements for customized computing solutions.

“We simplify the use of embedded technol-ogy.” This is the congatec commitment. It’s not just the products – it’s also the people at congatec which work hard to perform this promise. congatec is the right partner when it comes to embedded computing solutions.

www.congatec.com

Company Pro� le

19


MEDComponents Connection Technology

Images:R

osenberger

HochfrequenztechnikGmbH

&Co

.KG

Permanent magnets work permanently without an energy supply. Theattraction force on ferromagnetic materials can also be used with con-nectors and the retention force can be tailored to specific applications.

Magnetic andSelf-Mating ConnectorsToday's electrical devices are often equipped with a large

number of connectors.Handling plays an important role –especially in the case of connectors that are frequently

connected and disconnected by the user.Magnetic, self-matingconnectors offer an ideal solution in this respect, and are attrac-ting a great deal of interest, not least from themedical world.

The main advantages include the self-mating function on theone hand, and the tear-away function on the other hand. Self-mating works as follows:When the plug is approaching the so-cket, it is attracted by the magnetic force and virtually slidesinto the socket by itself. Thismakes it efficient andpleasant tohandle, and ensures that it is connected correctly.

The tear-away function refers to the fact that the connector in-tentionally disconnects when an acute (deliberate or uninten-ded) tensile force is applied to the plug or cable. This stopsusers from injuring themselves and prevents damage to theconnector. Thanks to the tear-away function, the connector isalso quick and easy to disconnect intentionally.

While the self-mating function is generally always seen as an ad-vantage and is therefore desirable, it is possible that the tear-away

function may not be required. In this case, the magnetic connec-tor can also be equipped with a lock which engages after the (self-mating) connection is established. It is therefore practical anduseful to use magnetic connectors even in such situations.

Your Expert for Magnetic Connectors

Rosenberger, a leading manufacturer of connectors, offers awide range ofmagnetic connectors. The company laid the foun-

TheMultiMag15 is a hybrid connectorwith15contacts,which can transmit the supply voltage andcurrent,Gigabit Ethernet, and several controlsignals at the same time.

The RoPD series is used in various battery charging applications formobile medical devices. Depending on the version, the connectorscan transmit currents of up to 40 A at a voltage of up to 60 V DC.

20

MEDComponents Connection Technologies

dation for this product line by acquiringMagCode AG in 2009.Rosenberger also acquired the core product sporting the samename: the MagCode Powersystem. This is a two-pin magneticconnector for charging various battery-operated devices. Rosen-berger recognized its potential and, from then on, steadily workedon expanding the portfolio. This resulted in the development of

magnetic connectors equipped withdifferent transfer functions.

In addition to supply voltage and cur-rent, these connectors also transmitelectrical and optical signals, as wellas any kind of electronic data. In me-dical applications, several functionsare often combined in one connector,resulting in the hybrid connector.

Specific and StandardConnectors

Given that there are somany differenttypes of applications, the correspon-ding requirements for connectors arejust as varied.

Anapplication-specific connector is often the only and– at thesame time – the ideal solution for the respective application.Nevertheless, Rosenberger also offers a variety of standardmagnetic connectors, which have been developed based onthe relevant medical device standards and common require-ments of themedicalmarket. These standard products are de-

USB is a widely used standard that is implemented in different connector formats (type A,Micro-B, etc.). There are various USB-compatible magnetic connectors for use in USB applications.

»

embedded-world.de

DISCOVER INNOVATIONSImmerse yourself in the world of embedded systems and discover innovations for your success.

Nuremberg, Germany

27.2 –1.3. 2018

2ew18P

E-code for free admission

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Exhibition organizer

NürnbergMesse GmbH

T +49 9118606-4912

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signed in such a way that one product or product line can alsobeused for different applications.Magnetic connectors are ty-pically used for charging and supplying portable and mobilebattery-powered devices, such as defibrillators, resuscitationdevices, respirators, electric wheelchairs, and prostheses. Insuch cases, the connectors generally transmit voltage, cur-rent, and simple control signals.

Applications for magnetic connectors for data transmissioninclude, for example, systems for patient infotainment anddatamanagement, digital X-ray detectors, andmedicalweara-bles. Rosenberger offers a variety of cross-application mag-netic connectors and adapters for standard interfaces such asUSB and RJ45, which are widely used in the medical worldand elsewhere.

High Requirements in the Medical World

As in virtually all areas where electronic data is generated,transmitted, and processed, the requirements of the medicaltechnology sector in terms of transmission speed and signalintegrity are continually increasing.

Furthermore, the safety of users and patientsmust be guaran-teed at all times in medical environments. Depending on theapplication, this can result in increased requirements in termsof insulation, contact protection, cleaning ease, chemical re-

sistance, flame retardancy, biocompatibility, tightness, etc.Last but not least, the frequency of use and the relatively longproduct life of medical devices require the connectors to be asconvenient and efficient as possible in terms of handling, aswell as particularly durable. In this respect, magnetic connec-tors offer a significant advantage over conventional ones.

AuthorHerbert Wurm,Product Management Medical & Industries

Rosenberger is currently developing the Magnetic RJ45 series. Thanks to the adapter and cable variants, the series can be used wherever con-ventional RJ45 connectors are used.

CONTACT

Rosenberger Hochfrequenztech-nik GmbH& Co. KGHauptstraße 1D-83413 FridolfingPhone +49 8684 18 1688www.rosenberger.com

22


Sphinx Tools Ltd. Switzerland

Gewerbestrasse 1 CH-4552 Derendingen

Phone +41 32 671 21 00 Fax +41 32 671 2111

[email protected] www.sphinx-tools.ch

Corporate profile More than 50 years of

experience in the field of medical technology. Specialisation in the

manufacturing of cutting geometries such as drills, milling cutters, taps, etc.

Sphinx Tools Ltd.: Your partner in medical technology

Company Profile

Sphinx Tools Ltd. sets standards for optimum quality and security. As a partner and OEM manufac-turer of high-quality instruments in the field of medical technology, we have acquired an extensive knowledge base. Our in-depth expertise is based on longstanding partnerships with leading interna-tional medical technology companies.

Products

■ Surgical bone drills ■ Cannulated instruments ■ Thread cutters ■ Schanz screws ■ Wire drills ■ Steinmann pins ■ Dental drills ■ Screwdrivers

Expertise

■ Long-term partner in the medical technology sector as OEM manufacturer

■ Support with the selection of materials and construction

■ More than 100 years of machining expertise ■ Know-how in the processing of high-quality materials

■ High flexibility ■ Complete supplier ■ Optimal manufacturing solutions for small and Iarge series production

■ Delivery times according to customer’s request

The cutting edge geometry technology from Sphinx Tools Ltd. guarantees low torque and thus a lower heat generation. The precisely ground and burrless instruments are extremely durable even under the most challenging conditions and can be sterilised over and over again. Our development department is a high-tech Iabaratory specialising in measurements to within a thousandth of a millimeter. We ensure that our customers can use their instruments with absolute precision and in the best interests of patient health.

Quality management system in compliance with

■ DIN ISO 9001:2015 ■ EN DIN ISO 13485:2016 ■ FDA registration: 9614438

Clean roomWe are operable for cleaning and packaging in accordance with GMP (Good Manufacturing Practice) in our own clean room approved of category 8 ISO 14644-1

23


Precision bearings from Rodriguez are used in manymedicalapplications – for example in a high precision x-ray machine withC-arm that is used for diagnostics purposes in oncology.

Precision Bearings forPrecise DiagnosisIn this extremely sensitive field of application installed

components must meet highest standards. For this rea-son, the Dutchmedical devicemanufacturer VDLKonings

has decided on turntable bearings fromRodriguez for the bea-ring of the massive swivel arm.

The Dutch company VDL Konings BV develops and producesmedical devices, systemsaswell asmoduleswhichareused inradiology for diagnostic and therapeutic purposes. The C-armis specially designed for oncology – where the success of atreatment largely depends on the radiotherapeutic planning,the simulation and the treatment evaluation. The C-arm isexclusively used for diagnostic purposes: In order to prepareandperform treatments accordingly, the location of the tumor,the position and dose of the radiationmust be determined pri-or to the procedure. The appropriate accuracy is imperative tokeep a procedure as small as possible in the final treatment ofthe patient. Another advantage of the C-arm x-ray machine isthe fact that prior positions are automatically and preciselyapproached again.

High Precision Positioning – with TurnTableBearings

A number of factors have an influence on the accuracy in ap-plication. This also include the mechanical components. Theindividual elements and assemblies form the base formeetingthe high demands placed on the system: The whole is only asgood as the sumof its parts. For the high-precision positioningof the massive C-arm, the component for the bearing of thislarge system, is of great importance. VDL equips this rotationposition with ball bearing slewing rings from Rodriguez.

Thehigh-performanceprecisionbearings are part of thePreci-sion Bearings business unit of the power transmission and be-aring specialist fromEschweiler. They are suitable for applica-tions in which large tilting moments need to be supported orwhere large bearing diameters are required for design-relatedpurposes. Thanks to their constructional design, they safelyabsorb radial, axial and tiltingmoment loads with one bearingpoint. Therefore, bearingswith radial and axial bearing combi-

Precision bearings fromRodriguez are used inmanymedical applica-tions – for example in a high precision x-ray machine with C-arm.


MEDComponents Connection TechnologiesImageleft:V

DLKo

ningsB.B.

otherimages:R

odrig

uezGmbH

nations can often be realized with only one bearing point, andexpenditure and costs for the design of the connection const-ruction and the installation of the bearings can often be signi-ficantly reduced. Different sizes and versions – depending onthe application requirements, without gear, with external orinternal gear – are available as a standard in two types, withdouble-sided sealed raceway system.

An Application-Specific Adapted Solution

Narrower tolerances for axial and radial runout and the techni-cal specifications provided by the customer required a custo-mized design with a customized internal gear for this applica-tion. For cases like these, Rodriguez has set up an in-houseproduction facility with high-performance machinery; here,individual solutions are implementedwithout ifs andbuts. Forthe turntable bearing for VDL, the material is first tempered.This heat treatment prevents the rings from warping in thesubsequent processing; warping would result in functionalinaccuracies both in diagnostics and radiotherapy. The outerringwas slightlymodified in order tomeet the installation spe-cifications, and the grease nipple was counter sunk. This pre-vents anything fromhooking to the arm in its rotarymovement.To ensure the arm rotates in the same plane, has no range ofmotion and has a homogeneous rotation, the bearing is clea-

rance-free anddesigned according to the specific rotationmo-ment specifications. In addition, the shape and tolerances ofthe gear teethweremodified to ensure smooth running, reliab-le motion accuracy and less wear.

„The interplay of the technical components must be exactlycoordinated,“ saysSvenHandels; the nativeDutchman is Pro-ductManager atRodriguez and the sales executive for the cus-tomer VDL. The motor defines the drive pinion which in turndefines the requirements for the ball slewing connection. Inaccordance with the drive power, they are equipped with a ge-aring with head reduction and profile shift. This design allowsfor highest accuracy in the positioning and thus a correspon-ding repeatability.

Flexible Response – Thanks to In-HouseProduction

Specially modified turntable bearings are also required inother fields of applications, for example as a hot version,which can be used in a temperature range of up to 150 °C. Forsuch high temperatures, the turntable bearing must be fittedwith a special seal that has high thermal and chemical resis-tance. The guiding of the rolling elements is implemented in asteel cage, because – just as in conventional rubber materialsfor bearing seals – syntheticmaterial would reach its limits un-der such operating conditions.

Here, the flexibility and know-how of technical special soluti-ons are particular strengths of Rodriguez, but also the possibi-lities offered thanks to the broad orientation of themachinery:In the area of precision bearings, for example, large diameterslewing bearings with outside diameters of up to 1,400 milli-meters, or even the increasingly popular rotary units withsmaller diameters starting at 15millimeters, canbemanufac-tured. In linear technology, thanks tomodern CNCmachinery,it is possible tomachine shafts andball screw spindleswith anouter diameter of up to 100mm. Rodriguez always maintainsits manufacturing facilities at the latest state of the art, withinnovative equipment and advanced tools.

Author:Nicole Dahlen, Director Sales &Marketing

The interaction of the technical components must be perfectlycoordinated

Ball bearing slewing rings in a C-arm x-ray machine

CONTACT

Rodriguez GmbHErnst-Abbe-Str. 20D-52249 EschweilerPhone +49 24 03 78 00www.rodriguez.de

25


MEDComponents Case Technology

ODU connectors and system solutions are used in medicaltechnology. All products from themodular rectangular connectorWhite-Line are specifically tailored to meet customer needs.

Ball Bearing Slewing Ringsin a C-arm X-ray MachineInmedical technology, the right diagnosis, a patient’s health

or even life itself candependon the failsafe functioning andsecurity of connectors. InMRI technology, for instance, the

ODU-MACWhite-Linemodular rectangular connector links themagnetic field-generating coil with the MRI system. This inter-face transmits the image upon which crucial examination re-ports and subsequent treatment decisions are based.

Proven Knowhow and Implementation Expertise

“The ODU-MAC has been part of our portfolio for 30 years,“ ex-plains Bernhard Säckl, manager of the rectangular connectorproduct family. “Our customers approach us with specificati-ons for imaging method requirements – and we come up withcustomized solutions for each application.“ In sodoing, thepri-mary focus lies in having a non-magnetic connector, since theinterfacemust not interfere with the strongmagnetic and alter-natingmagnetic fields of theMRI, which create the image. “Weusedifferent finishingmaterials andprocesses to ensure the re-quired specification profile is met,“ says Säckl. Completely se-parating the production of magnetic and non-magnetic partsguarantees that no “contamination“ can occur. When it comesto their non-magnetic properties, the careful examination ofevery single component is integrated into the process.

Bringing Together Function and Form

Depending on the requirements, the transmission of data andhigh frequency signals in the MRI occurs via eight, 12 or 16-channel coax or fiber optic cables. ODU combines the modu-les accordingly, thereby creating customizedconnector soluti-ons. The housing varieties are also customer-specific. “Weclosely coordinate our design proposals with the customer.Thenwe integrate thedesired locking type andconnector,“ ex-plains Säckl. The spindle locking’s outstanding features inc-lude its low insertion and withdrawal forces and clear opticaland tactile feedback. The break-away function, in contrast,enables emergency unmating without damage to the connec-tor or its contacts. The high-class ODU-MACmodular connec-

tor systems are not only used inMRI systems they’re also builtinto a wide range of medical devices around the world.

Mari: Precision Technology for Successful Surgery

Besides radiotherapy and chemotherapy, the standard proce-dures in treating brain tumors include the surgical removal ofall or some of the growth. This operation calls for precision andperfection— both from the surgeon and the instruments, be-cause knowledge and skill alone do not determine the suc-cessful outcome of surgery.

Time is also a factor. Constantly stopping to adjust the micro-scope interrupts the procedure and consumes valuable minutes

when the surgeon’s handscould be completing theprocedure. As a result, thedose of anestheticsmust beincreased, and this puts thepatient under additionalstress. The loss of time caneven be a matter of life anddeath.

Solving this problem be-came a goal of DavidPitskhelauri,MD, Ph.D., abrain tumor and surgicalepilepsy therapy specia-list, at the Moscow Bur-denko Neurosurgery Insti-tute in Moscow, Russia.He knew that if the micro-

scope had a hands-free setting, the surgeon would be able tooperate without stopping. And so the doctor, along with a pro-duct development firm, a manufacturer, and a specialist inelectrical connector technology joined forces to developMari,a precision instrument that enables the hands-free use of asurgical microscope, heralding a new age of neurosurgery.

TheMARI high-precision controlsystem and the ODUMINI-SNAP

26


MEDComponents Case TechnologyImages:O

DUGmbH

&Co

.KG

MARI, responds to the most minute movements of the opera-tor’s lips and the essential secure connections are ensured bythe ODUMINI-SNAP and six customized cable assemblies.

Safety in Everyday Medical Care

For its customer PARI, ODU created a stamped contact for anaerosol generator, used to support respiratory therapy for cysticfibrosis patients in the future. The four-contact connector nee-ded to be as small and manageable as possible. ODU obtaineda 1.27mm grid, by combining existing contact technology intoa customer-specific overmolded insulating body. Easy handlingis enabled through the flexible mating of the hermaphroditicdesign. Another feature is the additional locking nub, whichprovides tactile feedback on themating status. Cable bend pro-tection is integrated into the overmolding process.

Connections Continue Beyond the Connector

When the specification is to keep a system solution as small aspossible, there’s often an acute lack of space in the connector.ODU delivered a customized ODU-MAC White-Line connec-tor, complete with the matching cable assembly, for a shockwave therapy device for its customer MTS. “We devised a hy-brid cable in which we were able to combine HV and signallines as well as a fluid tube all in one custom-fit corrugated tu-be,“ says Säckl. The broad range of lines in such a compactspace increased the complexity of the cable assembly.

Medical Technology in Motion

Miniaturization is a key area requiring high density solutionsto ensure top performance transmissions in the smallest ofspaces. Another essential factor for manufacturers is growingcost pressure. This is why ODU is constantly working on thecreation of innovative technologies, andmaterials in newwaysto provide ever more efficient connectors and system soluti-ons. Today, ODU products are constantly proving their out-standing reliability in the medical field, and will continue toprovide applicationsecurity in the fu-ture, too.

MARI responds tominimalmovements of the lips and jaw.ODU’sMINI-SNAPensures secure connectionswith six customizedcable assemblies.

In addition to the connectors from the ODUMINI-SNAP series, ODUhas designed a total of six cable assemblies for MARI

CONTACT

ODUGmbH& Co. KGPregelstraße 11D-84453Mühldorf a. InnPhone +49 8631 615 60

www.odu.de

27


MEDComponents Fluidics

Images

Sensirion

AG,S

witzerland

Measuring Lowest FlowRates inMedical TherapiesWhile various countermeasures have been evaluated

and introduced, there is still room for improvementand for new technologies to be established. One no-

vel development with tremendous potential is a single-use li-quid flow sensor that is able to measure lowest flow rates anddetect common failure modes quickly and reliably.

Ambulatory infusion pumps are experiencing ever increasingpopularity in ambulatory and home care settings for the conti-nuous delivery of highly-concentratedmedication over severaldays. Herein, flow rates range from single milliliters up to afew hundred milliliters per hour (ml/h). Portable ambulatoryinfusion treatments have been able to dramatically reduce thelength of hospitalization with its related costs, while at the sa-me time greatly improving patient quality of life. For example,in the case of chemotherapy, it has been shown that conti-nuousdrug administrationhas abeneficial pharmacodynamicimpact on efficacy and toxicity, compared to traditional bolusinjections every 24 hours.

A typical elastomeric pump consists of a pressurized reservoirexerting continuous force on the medication, an IV adminis-tration set including a pressure drop element (e.g. a thin capil-lary used as a restrictor) which determines the required flowrate, and an IV catheter or injection port. These pumps are often purely mechanical and designed as single-use devices for

infusional chemotherapy, painmanagement, or chelation the-rapy. Their characteristic pressure profile is typically concave,i.e. the generated flow rate at the beginning and at the end ofthe therapy is higher than in the middle.

The actual flow rates of elastomeric pumps aremainly influen-ced by two parameters: the differential pressure between theinlet and outlet of the restrictor and the resistance of the rest-rictor itself.While the inlet pressure is determinedby thepres-sure profile of the pump’s reservoir, the outlet pressure is af-fected by several factors: the type of the injection site, the pa-tient’s specific vein back pressure, as well as the difference inheight between reservoir and injection site. The resistance ofthe restrictor is influenced by the viscosity of the medicationwhich in turn is determined by the solution’s molecular com-position and its temperature. In order tomaximize temperatu-re stability in spite of changing ambient temperatures, medi-cal device manufacturers typically recommend to tape therestrictor to the patient’s skin at all times. The currently estab-lished solutions, as described above, have a series of well-known shortcomings.

The single-use liquid flow sensor LD20

Medical procedures and thera-pies are often faced by the samechallenge: accurately measu-ring and controlling lowest flowrates down to the microliter perhour range. In most of these ca-ses the outcome of the therapy,as well as the well-being or eventhe survival of the patientstrongly rely on the reliable andcontinuous drug administrationin such low flow regimes.

28

»



The required flow rate accuracy according to internationalstandards is ±15%under very specific conditions.During a ty-pical daily routine, it is challenging for a patient to adhere tothe handling instructions that guarantee the specified perfor-mance. In consequence the real life flow rates often deviatedrastically from the intended values. While higher flow ratesmay result in an increased toxicity of the therapy, lower flowrates will reduce the treatment’s efficacy. Both deviations willprevent an optimal therapeutic outcome. Additionally, medi-cation not administered due to lower flow rates and thus lefto-ver in the reservoir, may require specialized waste manage-ment.Especially at low flow rates, clogging of the very thin restrictoror at the injection site is difficult to detect quickly and reliablywithout a liquid flow sensor. In most cases, it takes hours foran occlusion to get detected by the patient or nursing staff.This again will prevent an optimal therapeutic outcome.

The effects described above can currently neither be monito-red for direct feedback or remote support nor can they be re-corded for later analysis by the clinical staff.

Thus, many ambulatory infusion pumpmanufacturers are de-signing smart versions of their existing products. One possiblesolution is the seamless integration of a single-use liquid flowsensor, like the LD20 from Sensirion, into the infusion set.

In pediatrics and neonatology, the little and vulnerable pati-ents receive a lot of special care and attention, not only from

the nursing staff, clinicians and their parents, but also fromthemedical industry.

In this context, flow rates of 1 ml/h or even lower are typicaldue to the patients’ low body weights. Consequentially, theknown and inherent issues of the current infusion technology(start-up delays, flow-discontinuation and dependence onhydrostatic pressure) may have evenmore detrimental effectson the therapy outcome.

Administration of life-saving drugs with a short half-life, forexample adrenalin, must not be delayed or discontinued bythe infusion technology in question. However, this happensfrequently due to the compliance of the tubing and syringeplunger, the movement and vertical displacement of syringepumps during transport of the patient, or the loading of a newsyringe into the pumping device.

The fluidic balance of a child or a neonate has to be observedand calculated on a daily basis. The sum of any fluid injectedor ingested, be it drugs or nutrition, and the excreted fluid isnot only critical to the well-being of the child but also limited.

Single-use liquid flow sensors, integrated into infusion sets,will enable medical devices not only to monitor the adminis-

tered flow rates accurately, but also to detect the abovementi-oned common failure modes quickly and reliably.Continuousurine flowmeasurements of critically ill patients re-quire flow rates to bemeasured in the range of single millilitersup to 100 milliliters per hour. Acute Kidney Injury (AKI) is acommon complication (occurrence 20% - 30%) in critically illpatients in the ICU. The early detection and correct diagnosis ofAKI currently receives a lot of attention inmedical research anddevelopment. Patient mortality and the risk to develop a chro-nic kidney disease drastically increases with AKI onset.

Nowadays, AKI canbediagnosed on thebasis of laboratory da-ta, including a change in serum creatinine or in the excretionof waste products of the kidney’s nitrogen metabolism. Re-search showed that the urine output of a catheterized patientis more sensitive than biochemical markers to changes in re-

30



nal function. It exhibits a faster response than changes to thebiochemical composition of the urine.

The standardized RIFLE classification (risk, injury, failure,loss, end-stage) is used by clinicians to increase the sensitivi-ty and specificity of their AKI diagnosis. This classificationstates, that a decrease in urine output below 0.5 ml per kilo-gram body weight per hour for more than six hours is a first in-dication for an increased risk of acute renal failure.

The biggest issue faced today, when determining the urine out-put of a patient, is that it has to be measured and recordedma-nually in regular intervals by the ICU’s nursing staff. Only thencan a further trend analysis be performed. The possibility of au-tomatically and continuously measuring and recording urineoutputs would allow a timelier diagnosis and enable cliniciansto recognize or even prevent AKI onset. Again the LD20 single-use liquid flow sensor can solve this problem.

Common to all of the medical fields and applications descri-bed above, is that by using a single-use liquid flow sensor, im-portant measurement data and vital signs could be acquiredand stored automatically in the electronic patient data ma-nagement system (PDMS). This solves the issue of time-con-suming, inaccurate, and cumbersome hand written medicalcharts and allows the timely detection of adverse effects. Thedata would furthermore be easily available for a retrospectiveanalysis. Above all, it would free-up time of the nursing staff tobe spent on other tasks which still require personal attention.

All of these medical applications can be revolutionized or forthe first time enabled by using the LD20, the single-use liquidflow sensor from Sensirion.

LD20 Single-Use Liquid Flow Sensor

The LD20 series combines Sensirion’s proven liquid flow sen-sing technology in a single-use, cost-optimizeddesign for highvolume applications in the medical, life-science or food in-dustry. The LD20 sensors provide a bidirectional measure-ment of flow rates from below 1 ml/h up to 1000 ml/h, whilestill reliably detecting common failuremodes such as occlusi-on, free flow, or air bubbles with unprecedented speed andsensitivity.

Measuring Principle of a Microthermal CMO-Sens® Flow Sensor

CMOSens® Technology integrates an extremely fast, miniatu-rized thermal sensor together with the complete high-precisi-on evaluation circuitry on a single CMOSmicrochip. A heatingelement on themicrochip applies aminimal amount of heat tothe medium for a thermal flow measurement. Two temperatu-re sensors, positioned symmetrically up and downstream ofthe heat source, detect minute temperature differences withextreme sensitivity and thus provide the fundamental infor-mation on heat dispersion, which is directly correlated to theflow rate. Integrating the technology on a single chip ensuresthat the sensitive, analog sensor signals are amplified, digiti-zed and further processed without interference and with thehighest precision, enabling the chip to provide the user with acalibrated and linearized signal via a digital interface.

Author:Susanne Jungmann, Product Manager Liquid Flow SensorsSensirion AG

The LD20 series – single-use liquid flow sensors

Microthermal measurement principle

More Information

CONTACT

Sensirion AGLaubisrütistraße 50CH-8712 Stäfa ZHPhone +41 44 306 40 00

www.sensirion.com

31


MEDComponents Valves

Precision and Speedwithout Compressed AirLosses of compressed air due to leaks often amounting to

20%over the entire compressed air system. Electromo-tive valves solve these problems and therefore offer an

energy-efficient alternative in many cases. Unlike pneumaticspring-balanced solutions, they move almost instantly to therequired position without overshooting, which then remainsstable independently of themedia pressure. As simple, but in-telligent systems, they also offer numerous possibilities forprocess optimization.

There are different reasons why users want to dispense withpneumatic valves or replace themwith electromotive variants:For instance, there are some applications in which compres-sed air is neither available nor desirable. These include exten-sive storage systems with long distances between individualvalves, mobile facilities, for example, for local delivery of po-table water or processes in which compressed air is disruptivesuch as in clean rooms or painting plants. Other applicationsrequire high levels of control precision and speed combinedwith a low dead time – something that cannot be realized withpneumatic valves. Engine test benches would be typicalexamples. However, certain innovative plant concepts alsouse a combination of pneumatic and electromotive valves, forexample, where simple shut-off functions are pneumaticallycontrolled, while superior electromotive variants are used for

demanding control processes. In addition, more and moreusers are reducing the cost-intensive andwasteful use of com-pressed air by using electromotive solutions.

The fluid control specialist Bürkert offers a wide-ranging pro-gram of electromotive process control valves for all these sce-narios. Designed as seat or diaphragm valves, they cover abroad spectrumof applications. The spectrum ranges fromva-por deposition for baked goods and water regulation duringtextile bleaching to controlling hot water in dairy plants all theway to mobile temperature control systems. Additional appli-cations include metering steam and water in the foodstuffs orpharmaceutical industries, precise pressure control on enginetest benches, for example in FormulaOne, or in the cooling cy-cle of breweries.

Seat Valves: Fast, Accurate and Powerful

What sets these electromotive seat valves apart is their perfor-mance, which cannot be compared to that of pneumaticallyactuated valves. With a control speed of 6 mm/s and a closingtime of 3 to 4 seconds, they no longer exhibit the weakness ofmany electromotive process valves. Previous solutions some-times require several minutes to close, which is simply unac-ceptable for many applications. Depending on the require-ment, the control speed can be set to specific applications,electric stroke and closing limits can be defined and end posi-tions smoothly approached. Another feature of these valvescompared to pneumatic, spring-balanced actuators is thatthey approach the required position almost instantly and wi-thout overshooting. This position then remains stable irre-

Steam regulation in CIP plants: Ultra-precise, electromotive controlvalve combined with pneumatically actuated shut-off valves.

The advantages of electromotiveactuators compared with pneu-matic solutions are attractingincreasing attention. Althoughcompressed air is already avai-lable in many industrial environ-ments, it ranks among the mostcostly energy sources to generatedue to the high maintenancecosts and significant losses dueto leaks .

32

spective of media pressure. In the event of a pow-er failure, the safety position canbe approachedwith the help of the optional energy pack. Addi-tional emergency manual adjustment is alsoprovided. The valve position is displayed by a360° LED ring, which is clearly visible from adistance, and by a mechanical position indica-tor in case of a power failure.

The control valves are available as angle seat(type 3360) and globe valves (type 3361) withoptional process controller in nominal connec-tion widths of DN15 to DN50. Possible mediainclude gases, fluids and steam at media tem-peratures from -10 to 185 °C and operatingpressures of up to 16 bar. Bodies are availablewith flange, threaded sleeve, welded or clampconnections. Flow values range from 0.1 to 53m3/h. The high control resolution results from aminimal dead band of 0.1%. An electricsupply voltage of 24 V DC is required.Harsh environments are not a problem forthe rugged body, which offers degree ofprotection IP65 and IP67 in a sealed de-sign that is also easy to clean. The actua-tor surface is designed in accordance withthe EHEDG guidelines (European Hy-gienic Engineering and Design Group)and offers high resistance to cleaningagents. The control valves are supple-mented with on/off valves available as angle seat valves (type3320) and globe variants (type 3321). As a result, all require-ments for use in the foodstuff andpharmaceutical industry arecovered.

Diaphragm Valves: Hygienic, Dynamic and Durable

industries. The electric actuator with ball screw posi-tions the diaphragm almost instantly with high pre-

cision andanunusually high control speedof upto 4mm/s, which can be varied to suit the plantdesign. Pressure fluctuations or shocks in themedium do not affect the valve position. If ne-cessary, the safety position can also be approa-ched with the help of an optional energy packin case of a power failure. Useful functions forprocess control, valve diagnostics, and preven-tative maintenance are also provided. The val-ve position is indicated by the mechanical po-sition indicator and a 360° LED illuminatedring, which also indicates warnings and errors.The proven valve body anddiaphragms guaran-tee media separation, excellent cleaning cha-

racteristics, andminimal empty space. Thanks tothe high level of IP protection and low sensitivity to

shocks and vibrations, demanding ambient con-ditions are not a problem. The hygienic designenables quick and residue-free external clea-ning. The actuator force can be precisely tai-lored to the operating conditions tomaximizethe diaphragm service life.

In addition to the regular version, the diaphragmvalves are also offered as shut-off valves(type 3323) in connection widths of up toDN50.The valves that offer FDA,USPandEHEDG conformity are particularly sui-

table for clean-room, filling, packaging and CIP/SIP applicati-ons in the pharmaceutical and health care sectors, the dairy orcosmetics industries and for industrial water treatment.

Future-Proof Communication for Industry 4.0

Communication is possible using analog signals and with mo-dern field bus systems. With EDIP (Efficient Device Integrati-on Platform), the manufacturer has also created a practicalsolution that meets the growing demand for electric integrati-on solutions. This development paves the way to digital net-working and offers convenient operating and parametrizationpossibilities. The user can program and adapt the logic tochanging processes and operating conditions without theneed for an additional controller. The free Bürkert Communi-cator software can be used to set up diagnostic functions suchas monitoring of operating data or alarm messages for custo-mer-specific parameters. The electromotive valves functionas intelligent sys-tems offering nume-rous possibilities forprocess optimization.


MEDComponents Valves

Diaphragm control valves (type 3363) are also an ideal choicefor demanding control tasks in areas involving media contactin the food, drink, cosmetics, pharmaceutical or biopharma

Images:C

hristia

nBü

rkertG

mbH

&Co

.KG

The optional operating display shows the current operating states and ena-bles quick and easy configuration and diagnostics directly on the device.

CONTACT

Bürkert Fluid Control SystemsChristian-Bürkert-Straße 13 - 17D-74653 IngelfingenPhone +49 7940 10 0www.burkert.com

With the electromotive seat valve types,there are now process control valves that setnew standards with regard to performance,reliability, and efficiency.

33


MEDComponents Pumps

Images:ZublerG

erätebau

GmbH

Compressed air is ever-present in dental labs. The lab instrumentsand furnishings containmanymeters of tubeswithdozens of fittingsand connection components, all of which have to function reliably.

First Choice for“Third Teeth“The Zubler company in Ulm, a world market leader in

suction technology and ceramic kilns, has to rely onquality components through and through.

The origins of Zubler Gerätebau GmbH go back to the year1922. At that time, Karl Zubler, the grandfather of the compa-ny’s present-day owner Kurt Zubler, founded a company thatmanufactured electrical machines. After the war, the compa-ny was re-established as a service company for electrical ma-chines. Since 1992 theUlm-based company develops centralsuction systems for dental labs andmarkets an entire series ofinstruments and components with compressed air connec-tions. They include ceramic press kilns and CAD-CAM sys-tems for dental technology. The company also supplies the re-quired accessories and consumables from a single source.

Zubler is the only manufacturer of suction systems for dentaltechnology that can offer every individual customer configura-tion: fromsingle- andmulti-station to central suction systems.On the basis of many years of experience, Zubler also carriesout planning, installation and maintenance of the lab facili-ties. The equipment of a dental lab requires an extensive tech-nical infrastructure, which resides unnoticed in the back-

ground and includes abranched network ofexhaust air ducts andcompressed air lines.Compressed air is auniversal working me-dium that is easy toconvey and is used inmultiple applicationsat each workplace inthe dental lab. It isused to operate air

guns and pneumatic tools, to blast and blow off parts and topower hand grinders.

FromSuction Equipment to SpecialisedProducts

The family owned company entered the dentalmarket by coin-cidence. A dental equipment manufacturer had seen one ofthe custom-made suction devices in a dental lab and wantedto integrate a similar device in the manufacturer’s own pro-ductmix, which resulted in the first single-station suction sys-tem and was then produced in large quantities. The philoso-phy of Zubler Gerätebau requires that production and de-velopment take place in Germany. All electronic components,for example, are developed and assembled in Ulm, so that allcontrol elements come from in-house production. Any compo-nents not manufactured in-house are purchased regionally, ifpossible, which eliminates unnecessary transport distancesandcosts, and also ensures security of supply. EiselePneuma-tics GmbH&Co. KG inWaiblingen shares Zubler’s attitude to-ward providing products of especially high quality with thelabel: “Made in Germany“. For more than twenty years Eiselehas supplied the MSE with high-quality “background“ com-ponents for reliable compressed air connections thatmeet thehigh requirements of Zubler lab technology.

The equipment for a dental lab is a major, long-term invest-ment. Therefore, it is important to use long-lasting technology

The swivelling threaded angle connec-tion from the BASICLINE features anenclosed O-ring and is made of nickel-plated brass

A view inside theVarioPress300ceramicpress kiln: threadedconnec-tions with a release ring create a permanently leak-proof connectionof the polyamide pneumatic tubes

34


MEDComponents PumpsImage:EiselePn

eumaticsGmbH

+Co

.KG

and high-quality materials. This also applies to seemingly mi-nor details such as thepneumatic connections. Their seals ha-ve to be durable and reliable. Even small leaks in compressedair lines result in high energy costs over the course of a yearand the hissing sound of escaping compressed air is not con-ducive to a productive work atmosphere, since the dentaltechnician’s work requires special concentration.

High-Quality Technology that Lasts

For the reliable implementation of transition points, connecti-ons and branches in the compressed air system, the plug-typetube connections in series 14 of theBASICLINE offered by Ei-sele have proven ideal. Diverse versions and technical detailsmake it possible to implement virtually any type of connecti-on. They are available in different types, including straight,angle, double or T-connections and feature not only reliable le-ak-proof seals, but also application safety during installationand maintenance. An Eisele plug-type connection is easy todisconnect even after extended use, without the risk of leaks.

The high-quality components of the Waiblingen-based com-pany provide a very economical connection solution throug-hout the entire life cycle. The standard versions are availablein nickel-plated brass. Every year, Zubler orders and installslarge quantities – ca. 30,000 to 40,000 – of the nickel-platedversions of about 100 different Eisele components, includingquick-release connectors, connecting elements and adapters,in devices and customer installations. These components aresupplemented by about twelve kilometers of polyamide- andfabric-reinforced compressed air tubes. The designers andproject planners have the CAD data and the well-structuredproduct catalogue at their disposal, to minimize the effort inselecting the right parts in the case of new developments. Mo-re than half of the material is needed for the installation ofcentral suction systems.

Advanced Technology for Fine Craftsmanship

The FZ2 Variomatic is a highly reliable and clean suction sys-tem used by four workplaces that was specially developed forsmaller dental labs. As with every workplace connected to acentral suction system, each suction point automaticallyopens when the handpiece is actuated and closes after a post-operation period for removal of the residual dust.

A basic principle of Zubler suction technology is not only todistribute air, but to individually control each point where theair is used. As soon as a suction machine is required to supply

Multi-station suction systems, such as the FZ2 Variomatic shown he-re, ensure a dust-free workplace even in the case of highly dust-inten-sive tasks, such as those using belt sanders

35

»

more than one workplace, Zubler uses a pneu-matically actuated valve for each suction point.A swivelling threaded angle connector fromthe BASICLINE provides for a secureconnection of the polyamide compres-sed air tube in this application. Zublerinstalls about 3,000 suction pointopeners every year and has done so formore than 15 years. Each workplaceneeds at least four Eisele components,making a total of 180,000 connecti-ons for compressed air tubes, and sofar there have been no complaints.

The version with a release sleeve ena-bles repeated secure and convenientconnection and disconnection, as wellas of dirty connections or in difficult-to-access areas, for example behindthe lab furnishings. The release slee-ve protects the inner collet from impu-rities. In the BASICLINE, the nickel-plated brass plug-type connectionswith a release sleeve and one or twoseals is the right choice for many ap-plications. For Zubler themetal versi-on is especially important, since – in the experience of theZubler development department – plug-type connectors witha release ring made of plastic cannot guarantee the requiredlong-term reliability and robustness. Moreover, the handlingof themetal connectors ismuchmore convenient. Eisele is the

only supplier of connection components to offer a versionwith a release sleeve.

Components from series 14 of the Eisele BASICLINEare also installed in the VarioPress and Vario ceramickilns. Threaded connections with a release ring areused here, since the connections inside the kiln, as op-posed to the connections in the lab installations, onlyhave to be disconnected in the case of repairs. Whetherthe requirement are for evacuation of the kiln chamberfor firing ceramic layers or actuating a pneumatic cylin-der for a press ram, the valves must always feature sui-

table connection technology that can withstand the envi-ronment within a kiln with temperatures as high as 1,200 de-

grees Celsius. The result: dental plates of outstandingquality, towhichEisele hasmade a significant con-tribution, virtually unnoticed.


MEDComponents Pumps

— —— — — — — — — — — — — — — — — — — — — — — —

PROGRAMMABLE PUMP The Intelligent Programmable Pump from Fluid Metering, Inc.combines FMI’s precision valveless STH Stepper Pump with inte-

gral programmable driver in a compact design ideal for integration withOEM instrumentation. The driver provides precision servo control of the STH

pumps stepper motor for resonance-free, quite operation.

Having 5 programmable inputs and 2 outputs, the IntelligentPump is compatible with multiple programming platforms inc-luding, Visual Basic, C/C++, Delphi, LabView. Analog 0-5 VDC,RS-232, and CANopen protocol are supported with an optionalEtherCAT communication module available.

The Programmable Driver and Stepper provide precision con-trol of FMI’s CeramPump® integral valveless piston pump.FMI“s CeramPump® technology features only one movingpart, a sapphire-hard ceramic piston, in contact with fluid.The rotating and reciprocating piston accomplishes both thepumping and valving functions effectively eliminating checkvalves present in conventional reciprocating piston and di-aphragm pump designs.

www.FluidMetering.com

CONTACT

Eisele PneumaticsGmbH+Co. KGHermann-Hess-Straße 14-16D-71332WaiblingenPhone +49 7151 17 19 0www.eisele.eu

TheVarioPress300ceramic press kiln is usedfor processing of diverse established andinnovative ceramicmaterials for use in dentalplates

36


The RICO Group is a technological leader and global supplier of elastomer and LSR-plastics solutions. It consists of four cutting-edge manufacturers with locations in Europe and North America.

RICO’s portfolio of services range from assisting customers with product develop-ment, production of the molds, to highly auto-mated component production. RICO’s cus-tomers are located around the globe and in a range of industries including medical, auto-motive and sanitary.

Specializing in medical and life science applications, Silcoplast, located in Switzer-land operates a Class DIN ISO 7 clean room. RICO Elastomer Projecting, based in Austria offers the technology leader with the toolshop and a material testing laboratory and pos-sesses a non-certi� ed Class 8 clean room. SIMTEC, the US based LSR-molding-special-ist uses laminar-� ow manufacturing cells for life science applications. .Advanced molding- and automation technology is the common USP of the Group.

Customers bene� t from cutting-edge Liquid Injection Molding - and Multi-shot- technol-ogy to open a whole world of new possibili-ties, from product-development to manufac-turing world-class products. Be it a new functional part within a pump housing, a valve, plungers, seals, gaskets, or a new respiratory mask – just to name a few; the RICO Group combines technology, expertise and experienced professionals to offer its customers with solutions to help turn their ideas into reality. At the end of the day it’s about working with the best in the industry.

RICO ELASTOMERE PROJECTING GMBHHeadquartered in Thalheim bei Wels in Upper Austria, RICO Elastomere Projecting GmbH (www.rico.at) specializes in injection molds, automation and elastomer parts production, in particular Liquid Silicone Rubber (LSR) and High Consistency Rubber (HCR). Molded parts are produced using one-, two- or multi-component injection molds. The company currently employs 210 highly quali� ed staff. In addition to automated and complex molds, RICO also produces high-volume silicone- and plastic parts production. The company has obtained ISO 9001 quality certi� cation as well as environ-mental certi� cation with ISO 14001 : 2014 and also – as one of the � rst companies in

Austria – IATF 16949 : 2016 . Currently, RICO is expanding its production area for the 6th time. The new extension (to be � nished in summer 2018) includes a cleanroom to meet hygienic standards, more than 4000 m2 new production space, a logistics center, a high bay warehouse and more space for the development laboratory.

SILCOPLAST AGSilcoplast AG in Wolfhalden, Switzerland (www.silcoplast.ch) specializes in a variety of applications, ranging from medical to the electrical applications, and also manufactures specialty products such as � lter tissue fabric. The company processes LSR, thermoplastics and high consistency rubber. DIN ISO class 7 clean rooms play an important part in pro-duction. Silcoplast has obtained ISO 9001 : 2015 certi� cation as well as ISO 13485 : 2012 certi� cation for the manufac-ture of medical products.

SIMTEC SILICONE PARTS LLCThe latest addition to the RICO GROUP is SIMTEC SILICONE Parts, based in South Florida, USA (www.simtec-silicone.com). SIMTEC supports a number of the world’s leading companies in the development and production of high end-customized liquid silicone rubber (LSR) components and 2- and multi- shot LSR and thermoplastic components and operates laminar- � ow cells. The company is certi� ed in accordance with the ISO 9001 : 2008, ISO/TS 16949 : 2009 and ISO 13485 : 2003 standards.

HTR ROSENBLATTL GMBHHardening technology specialist HTR Rosen-blattl GmbH is a subsidiary of RICO Elasto-mere Projecting GmbH. Using state-of-the-art processes and technology to produce effec-tive heat-treated mold steel, a pre-requisite for a properly functioning molds, HTR’s production facilities also feature next-genera-tion vacuum furnaces with a patented cooling system.

Company Pro� le

RICO Elastomere Projecting GmbH

AustriaAm Thalbach 8

4600 Thalheim/WelsT +43 7242 76460F +43 7242 76470

of� [email protected]

37


MEDComponents Lifting Columns

Electrically adjustable lifting columns from RK Rose+Kriegerensure high-precision adjustment of the optical system in DIERSbiomechanical measuring systems

Precise PositioningRequiredWhen it comes to height adjustment, electric lifting co-

lumns are now virtually indispensable in the medicaltechnology sector and related fields. DIERS Internatio-

nal GmbH was initially drawn to these columns because of theirextremely quiet and high-precision operation. Established in1996, the family-run company develops, produces and distribu-tes biomechanical measuring systems for the holistic analysis ofthe human body. Typical users of these systems are, amongothers, orthopaedists, orthopaedic technicians, physiothera-pists, dentists, orthodontists and sports physicians.

Thanks to its pioneering formetric measuring technology,DIERS is now world leader in the field of light-optical, radiati-on-free 3D/4D spine and posture analysis. This system uses alight projector to project a line grid onto the back of the pati-ent, which is then recorded by a camera unit and analysed bycomputer software. This analysis produces a three-dimensio-nal model of the surface – a sort of virtual plaster cast of thepatient's back. The DIERS formetric system also delivers a 3Dmodel of the spine, which enables a reconstruction of the spa-tial arrangement of the spine and pelvic position.

Prior to scanning, the spinal and posture analysis systemneeds to be adjusted to the patient's height. For this height ad-justment, DIERS opted for a three-stage electrically adjustab-le lifting column from RK Rose+Krieger. „During our searchfor a suitable lifting column, we had – and still have – threemain criteria“, said Christian Diers, Managing Partner ofDIERS International GmbH. „The stroke needed to be bigenough, the stroke element needed to be able to accommoda-te the weight of the measuring system and the lifting columnsneeded to be certified to EN 60601 for medical devices.“

Practical Square Design

DIERS found that themedium-sized Alpha Colonne electricallifting column from RK Rose+Krieger met all of its require-ments. The electric lift column is equipped with square-sha-ped guide profiles and is designed for amaximum load of 100kg, so that it can easily accommodate the 20-kg weight of theDIERS measuring system. Unlike other column systems, theAlpha Colonne also offers an additional third guide stage,which enables it to achieve a maximum stroke of 700 mm or,

Based on the chip card controller of eXcio Pelvictrainer the automatic positioning of the optimal exercising position of a patient can be stored

38


MEDComponents Lifting ColumnsImages:R

KRose+

KriegerG

mbH

together with the installation length of 820mm, a total lengthof 1,520mm.The edge length of the outer columnstage of themedium-sized telescopic lifting column chosen by Diers is128 mm (Large: 163 mm). Despite its slim shape, the gene-rous overlapping of the three guide stages makes the AlphaColonne extremely stable, even when fully extended.

„Thanks to its square profile, the Alpha Colonne presents an at-tractive harmonious whole in combination with ourmeasurementsystem“, explained Diers, citing yet another reason to opt for theelectrical height adjustment system. Because RK Rose+Kriegerdiscreetly integrates the control system in the lifting column, itdoes not spoil the clean lines of the combined systems. It is con-trolled by DIERS via the relay circuit of the device electronicswhich, in turn, are controlled by aPC. „While we did not place anyparticular demands on the control of the lifting column, we wan-ted it to be easy to integrate – and it certainly was“, said Diers.

At the start of their collaboration, more than 15 years ago,DIERS initially used a standard version of the Alpha Colonne.However, in the course of their collaboration, RK Rose+Krie-ger customised the connector plug to meet the requirementsof the DIERSmeasuring system.

Zero Backlash Even After Years of Use

The Alpha Colonne is suitable for both tensile and compressiveloads of up to 3,000 N. It is self-locking, even under maximumload, and is fitted with an integrated limit switch. Pre-set sliderunits ensure zero backlash, even after years of use. The connec-ting plate has an in-built self-correction feature which enablesthe fine adjustment of the installation dimensions by +3 mm,thus ensuring easy connection of the lifting column to the envi-ronment. Themaximum travel speed of the telescopic stroke ele-ment – also available in special lengths on request – is 18mm/s.

Synchronous Versions: Installation andAlignment Made Simple

RK Rose+Krieger also offers special controls for applicationsrequiring the synchronised operation of up to four Alpha Co-lonnes, such as the height adjustment of worktables or desks– as well as the RK SyncFlex, a system for the level alignmentof the columns. RK SyncFlex adjuster plates facilitate the ho-rizontal and vertical alignment of the lifting columns, whichprevents any distortions that could cause over-determinedsystems to fail in the event of overload, whereby the horizontalcompensation in the Z-axis enables the freedom ofmovementrequiredwhenmoving the lifting columns. The vertical adjust-ment levels out any unevenness in the mounting environmentand aligns the lifting column around the X-Y axes.

Lifting Columns for Virtually Every Application

In addition to the Alpha Colonne, the RK Rose+Krieger pro-duct portfolio includes numerous other lifting columns forelectrical height adjustment in applications outside its estab-lished stronghold in themedical technology sector. This inclu-des the product family of the slimMultilift II lifting columns –which offers a telescopic version of the lifting column, a versi-on specially for ESD assembly tables and a lifting columnwithintegrated damping system – as well as the particularly slimli-ne RK Slimlift with a diameter of just 92 mm, the extremelystable RK Powerlift lifting column series and the multi-stageLambda Colonne for high tensile and compressive loads up to4,500N. The entire technology of these columns is discreetlyintegrated and invisible to the eye, so that no special claddingis required. Users do not generally require any special electro-technical knowledge to put these devices into operation.

Conclusion: Whatever your application – whether you requirethe height adjustment of medical technology systems, work-station systems or complexmechanical engineering systems –the product portfolio of theMinden specialists for linear tech-nology has the right lifting column for you.

Author:Bernd Klöpper, Head of Marketing, RK Rose+Krieger GmbH,Minden, Germany

The RK Rose+Krieger product range offers a broad portfolio of liftingcolumns for electrical height adjustment

CONTACT

RK Rose+Krieger GmbHPotsdamer Str. 9D-32423Minden, GermanyPhone +49 571 93 35 0www.rk-rose-krieger.com

39


MEDComponents Optical Components

NextGeneration of Point of Care devices –EmbeddedVision entersclinical realm

Diagnostic Devices toTakeawayThepast few years have seen the rise of a powerful gene-

ration of processing boards capable of replacing muchof the work previously performed by PC-based systems.

At the same time, industrial cameras for machine vision andthe Medical & Life-Science domain also evolved quickly. Ca-meras that were once large and expensive can today be produ-ced affordably and in ultra-compact designs. Some of the ca-meras are hardly larger than a stamp but are relatively easy tointegrate, even into very small Vision systems. There are anumber of factors driving development, perhaps most promi-nently a drop in Total Cost of Ownership (TCO) and the trendtoward miniaturization.

When small processing boards are combined with miniaturi-zed camera modules, the result is known as 'Embedded Visi-on.' Embedded Vision offers benefits in many different fieldsof application – from consumer electronics and the automoti-ve industry to industrial automation and medical products.

These new, more compact devices are already being put towork in medical technology, especially in the fields of derma-tology, ophthalmology and laboratory automation.

Cost-effective manufacturing options and new form factors aregiving today'smanufacturers ofmedical devices the freedom toexplore an entirely new world of product designs. Devices thatwere once bulky and stationary can nowbe built formobile use.

Sample Application Embedded Vision: DigitalDermatoscopy

The World Cancer Research Fund International has declaredskin cancer in its various forms to be themost common type ofcancer. More than 232,000 cases of melanoma are identifiedeach year. The earlier the cancer is detected and treated, thebetter the chances of survival for the patient.

One of the most frequently applied diagnostic procedures forearly detection of skin cancer is dermatoscopy. Physicians ap-ply a traditional dermatoscope to examine suspicious skin pig-ments by viewing the affected section of skin under magnifi-cation (Fig. 1). When the patient returns for a follow-up exam,the physician then reviews the spot again under a magnifyingglass and attempts to determine whether any changes haveoccurred. It's easy to see how a digital photo of the suspiciouspigment using an integrated camera canmake it much easy toassess whether changes have occurred. The physician can re-view an image taken using the same colors and lighting condi-tions, and even apply software for additional support. Diagno-sis reliability and standardization is increased, and even thesmallest changes in color and radius can be detected. Anothermajor benefit: the digital image is compatiblewith use in com-puter-aided algorithms (such as convolutional neural net-works) for image analysis. Moreover, the image can also besent to other clinicians if a second opinion is desired.

The camera plays a lead role in this type of medical product –after all, the diagnostic proposal is based on an image captu-

The dermatologist uses a dermatoscope to examine suspicious skinpigments.

40

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The Bürkert gas mixer for continuous positive airway pressure (CPAP) devices unites

leading-edge innovation with decades of fl uid technology expertise. It’s a powerful combi-

nation for developing your next-generation medical device portfolio.

The Bürkert CPAP gas mixer delivers an intelligent, modular platform for creating feature-rich medical devices. It’s the ideal solution for meeting your customers’ needs today and in the future. Now you can combine state-of-the-art functions across your entire product line.

The Bürkert gas mixer • makes it easy to design innovative, customized CPAP solutions • unites valves, sensors, electronics in a single medical device • is guaranteed against leakage for the life of the unit • offers a modular combination of push flow, CPAP pressure triggers,

high-frequency oscillation, and percent-accurate FiO2 functions

The CPAP gas mixer: the freedom to innovate

www.burkert.comWant to know more? Just call: +49 (0)79 40 10-0 or visit

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Start engineering your next success today.


MEDComponents Optical Components

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red by the camera. For the images to be used as part of anextended series of examinations, numerous factors mustfirst bemitigated, including the fluctuating lighting intensi-ty and different viewing angles. Color fidelity is of crucial im-portance here, as reproducible results are essential to accu-rate diagnostics. Unlike their counterparts from the consu-mer electronics world, industrial sensors are excellent atthis task. They are durable, pre-calibrated and produce reli-ably identical measurement time and again. Beyond this,the developer can adjust every single element of the imagingprocess, from the photons to themeasurement values.Massmarket camera modules simply do not offer that much con-trol over how they work.

Embedded Vision: Easy to IntegrateComponents, Even in Complex Systems

Miniaturization of the components (camera, CPU, etc...) isonly the most visible part of the development. Hardwarechanges have also occurred under the hood, many of whichhelp make medical Embedded Vision systems much morepractical.

Whilemost industrial cameras work with interfaces compliantwith the GigE Vision or USB3 Vision standard, Embedded Vi-sion devices typically work with low-level interfaces such asMIPI CSI-2 or LVDS-based interfaces such as Basler's BCONfor LVDS. The differences between the different interfaces aresignificant: BCON for LVDS uses the standardized GeniCamAPI, which among other benefits specifies an easy-to-use pro-gramming interface. By comparison, CSI-2 standardizesimage transfer, but doesn't specify the API.

The integration costs for Embedded Vision systems are higherthan for traditional PC-based systems. A standard industrialcamera with housing and USB 3.0 interface will be plug-and-play compatible with all standard operating systems. Low-le-vel interfaces can't offer that. Developers will need to program

them before the first image can be captured.This is where camera manufacturers can addvalue: the BCON for LVDS camera, for exam-ple, comes in a version with low-level interfaceas well as a USB 3.0 interface. In this way,image quality and camera functionality can beevaluated after just minutes of setup, no cus-tom development required. Because the pylonCamera Software Suite works with both PC-ba-sed and embedded architecture systems, de-velopers can first develop on a PC-based sys-temand thenport the completed application tothe embedded system. This saves precious re-sources during the development process.

To further cut the complexity of integration, ca-mera makers like Basler have also created De-velopmentKits for their cameramodules. Each

Development Kit contains a processing board and a cameraconnected to the board via a ribbon cable. Developers can usethis gig to gain insight into the software architecture. There'sno need to design a complete connection from scratch, asma-ny functions can be adopted wholesale from the reference im-plementation. The developers can instead focus on the actualmedical application, which is their company's real core com-petency.

Summary

Given the higher integration costs, why should amedical tech-nology company bother with Embedded Vision systems at all?The answer is simple: beyond a drastic reduction in Total Costof Ownership when higher unit counts are produced, Embed-ded Vision also enables systems that were simply technologi-cally unattainable in the past. These benefits are tremendous-ly important in an age wheremedical devices are gettingmoreportable and user friendly by the day. Medical technologyfirms are taking full benefit of the potential inherent to Em-bedded Systems to dream up new innovations, all while cut-ting costs.

AuthorPeter Behringer, Product Market Manager,Basler AG

Components of an Embedded Vision system

CONTACT

Basler AGAn der Strusbek 60-62D-22926 AhrensburgPhone +49 4102 46 35 00www.baslerweb.com

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MEDMaterials &Procedures ConstructionMaterialsImages:G

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Heavy metal on a tungsten basis with a high radiation absorptioncapacity is an ecological alternative to toxic lead

Ecological Alternativeto Toxic LeadEUDirective 2011/65/EU (RoHS2) regulates the use of

certain hazardous substances in electrical and electro-nic equipment. Lead is ranked at the top of the list,

even higher than mercury and cadmium. The heavy metalused as radiation shielding or for anti-scatter grids due to itshigh atomic mass is highly toxic and does not break down ea-sily, which is why a weight proportion of only 0.1 per cent ispermitted in new electronic and electric equipment. It alsohas a lowmelting point of just 327 °C, constituting an additio-nal hazard in case of fire.

The Bavarian company Wolfram Industrie offers an innovati-ve, more environmentally friendly alternative with Triamet, aheavy metal alloy on a tungsten basis: thanks to its specifichigh density and the resulting radiation absorption capacity,the dimensionally stable product that is available in both aniron-nickel and a copper-nickel binder phase even shieldsagainst gamma radiation. While tungsten is normally difficultto process, it can be shaped into blanks using a powder-metal-lurgical process in this form. Subsequently these blanks canbe processed further with little effort.

Since tungsten is a very dense and heavy material with a den-sity almost as high as gold, it is particularly well suited for rest-

ricting beam inlets in collimators or shielding against high-energy electromagnetic radiation. Dangerous gamma radiati-on and X-rays in particular can be contained thanks to the veryhigh absorption value of the metal powder mixture.

Due to the highmelting point of Triamet atmore than 1,000 °C,which is much higher compared to lead, there is no risk of mel-ting in case of a fire. However, only powder-metallurgical pro-cessing is possible due to this special characteristic: for theproduction of Triamet, tungsten powder is mixed with iron andnickel or copper and nickel powders. Subsequent shaping is ei-ther realised hydraulically with binding agents and a press, orisostatically under great pressure of 2,000 to 3,000 bar. Theformer is suitable for smaller dimensions, the latter for large-scale components. The resulting green parts are sintered intosemi-finished products in an electrically heated vacuum ovenor in a reduced hydrogen atmosphere.

Sintering Process at 1,500 °C Thanks to Nickeland Iron Binder Phase

Wolfram Industrie uses a nickel and iron binder phase for theproduction of Triamet, added to the tungsten powder at the ra-te of three to ten percent. Nickel acts as a catalyst that acce-lerates diffusionprocesses on the surface of the tungstenpow-er and thereby reduces the sintering temperature by about1,000 °C. Subsequently the Triamet green parts are sinteredat about 1,500 °C – in contrast to the 2,500 °C required forpure tungsten – so that a uniquemicrostructure with a spheri-cal tungsten phase encased by the binder phase is formed.

“Wolfram Industrie produces Triamet with a very high densi-ty,“ reports Dipl.-Ing.Wolfgang Jung, themetal expert respon-sible for research and development. It is declared at G19 andis about 18.8 ± 0.2 g/cm3. Amaximumdensity of 19.3 can beachieved with pure tungsten – which in fact is about 8 g/cm3

higher than lead. The lower the proportion of the binder phasethe higher the density will be. With the G14 version of the pro-duct for example, the minimum density is 13.9 ± 0.2 g/cm3.“Our material developments are based on a good mix of ourempirical experience and theoretical insights,“ Jung explains.“Often the idea for a new material or a new process emerges

Compared to lead frequently used for medical technology applicati-ons in the past, space-saving Triamet sets itself apart in that it doesnot need any supporting structure due to its high resistance.

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MEDMaterials &Procedures ConstructionMaterials

through cooperation with our customers. As a rule there areclear requirements here. Cooperation with universities is alsovery valuable to us for implementation.“

Diverse Uses of Tungsten and Triamet inMedical Technology

A mixture of tungsten granulate and epoxy resin is used as abackingmaterial in ultrasoundheads (transducers) tominimi-se interfering acoustic reflections. Here the acoustic impe-dance of the backing material is increased by adding tung-sten. Triamet is used in radiation therapy to shield againsthard gamma radiation.

“Radioactive seeds that are delivered to a tumour and subse-quently removed again during HDR brachytherapy can be sto-red in containers made of Triamet,“ Jung explains. Shieldingphials for radiopharmaceuticals to reduce the radiation expo-sure of employees constitute another possible application. Itis also suitable for isotope containers thanks to its dimensio-nal stability that ensures easy cleaning and sterilisation. Tung-sten is atoxic and not environmentally hazardous according toits RoHSconformity, so that no coating is required. In additionto shielding elements for medical diagnostics and radiationtherapy, Triamet can also be used as a material for micropro-bes and electron microscopes. Compared to lead frequentlyused for these applications in the past, space-saving Triametthat meets the requirements according to ASTM B777 alsodoes not need any supporting structure due to its high resis-tance.

Triamet is available as an S and G-material. The binder phaseof the former consists of copper and nickel. It is paramagneticandonlyweaklymagnetisable,making it suitable for use in theproximity of strongermagnetic fields, for example inmagneticresonance tomographs. The binder phase of the G-material ismade of iron-nickel compounds and, in contrast to the S-ma-terial, is ferromagnetic.

Universal Applicability of the Heavy MetalPowder also in other Fields of Application

Aside from medical technology applications, Triamet is oftenused as a counterweight or balancingweight in the automobileindustry and also in aluminiumcasting due to its very good du-rability and extremely lowwear. The product is used inmecha-nical engineering and plant construction as well because Tria-met with its highmodulus of elasticity and themicrostructuretypical for sinteredmaterials has excellent damping characte-ristics, making it capable of considerably reducing vibrations.Compared to steel, theTriametworkpieceswith340-390GPahave amodulus of elasticity almost twice that of the common-ly usedV2Asteelwith200GPa. This reduces deflectionunderthe same load by 40 per cent.

CONTACT

Gesellschaft fürWolfram Industrie mbH &Bayerische Metallwerke GmbHLeitenweg 5D-85221 DachauPhone +49 8131 703 0www.wolfram-industrie.de

44

The lower theproportion of thebinder phase, thehigher thedensitywill be – indicatedhere by thenumbers “17“ and “18“.However, theductilityof the heavy metal also increases as the binder proportion rises.



More Features withMiniaturized DevicesThe biocompatible material system developed by Heraeusenables new applications in minimally invasive surgery. Cal-led CerMet, the compound of metal (platinum) and ceramic(aluminum oxide) creates a high-density, extremely robustmaterial that can be used to create circuits in very small com-ponents with relatively simple automated processes.

Jens Trötzschel, Vice President Advanced Technologies at He-raeus Medical Components, explains the importance of Cer-Met for developing newmedical implants.

MED:MED: Mr. Trötzschel, Heraeus has developed a materialand process system with CerMet. What advantages does thecompositematerial bring?

Jens Trötzschel: Active medical implants that are implan-ted in the human body pick up electrical signals or emitelectrical signals, like a pacemaker. In order to encapsulatethe sometimes toxic materials in electrical componentssuch as batteries, these components are usually encased ina titanium housing. The medical device emits the electricalsignals through an interface called a feedthrough. Thesefeedthroughs are produced manually in a labor-intensiveprocess in which tantalum, niobium, or platinum metal wi-res are soldered with a ceramic insulated body using goldsolder. It’s a process that has been used for decades, butwhich has its disadvantages. The components cannot beminiaturized at will. The number of pins to be soldered isalso limited with this technology. It is currently impossibleto create feedthroughs with 100 pins or more. As the num-ber of soldered pins increases, so does the risk of flawedsolders, and therefore a higher discard rate. If even one sol-der is faulty, the entire component is unusable. Moreover,an automated production process for this type of feedth-rough would not be economical because the amount offeedthroughs is not high enough to justify the automationeffort. For these reasons, the feedthrough technology usedfor decades is increasingly becoming an inhibiting factorfor miniaturization and further innovation in the area of ac-tive medical implants. We want to eliminate this limitationwith our CerMet technology.

MED: MED: The CerMet biocompatible material system wasdeveloped based on an existing technology, high temperatureco-fired ceramics (HTCC). What was your approach?

Jens Trötzschel: There are already a number ofmetal-ceramicmaterials, which are used in a variety of different applications.Molybdenum Cermet is used in the lighting industry and goldCermet in the jewelry industry. However, these Cermets oftencontain a significant percentage of glass or non-biocompatib-le metal. This is where our material system differs. Throughcomprehensive testing, we have succeeded in creating a com-pound of high-purity aluminumoxide and platinum.But thesematerials are inert and show no chemical reaction with eachother. For that reason, we studied the particle sizes, particlesize distributions, and the particle forms to find the optimalpoint at which the platinum and aluminum particles form aninterlinked composite without additives. As a result, we areable to produce a hermetically dense, solid, and structurallyuniform metal ceramic that offers conductive feedthroughs.The ceramic phase has an insulating effect while the platinumparticles ensure electrical conductivity. It is important thatthe platinum particle density is high enough to conduct elect-rical currents through the ceramic matrix.

MED:MED:Which advantages does the biocompatible systemoffer in detail?

Developers at Heraeus havesucceeded in doing what haslong been considered impos-sible: creating a glass-freecompound of high-purity pla-tinum and aluminum oxidethat yields an extremely den-se, robust, and biocompatiblecomposite material.

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Jens Trötzschel: The medical devices that we use todayneed to keep getting smaller in order to enable minimallyinvasive surgery and to keep the risk of the body rejectingthem as low as possible. In addition, miniaturized medicaldevices with a smaller volume also have less surface areafor bacteria to colonize. Therefore, miniaturized medicaldevices also reduce the risk of postoperative infections. Atthe same time, the functional requirements for thesemedi-cal devices are increasing. Ultimately, a treatment can beplaced more effectively if you can also select the optimallocation for this treatment or stimulation. For this reason,an increasing number of channels for sensing is needed—aneed that can be met with the CerMet technology. There isalso the safety aspect. The CerMet material offers the ad-vantage that redundant channels can be provided withoutnegatively impacting the size of the device. If the commu-nication channel for a function fails, another channel isavailable so that the medical device can remain implantedin the body. In addition, CerMet allows for three-dimensio-nal structures: Until now, a feedthrough had one input andone output. However, the new material allows branchingdue to its layered construction and therefore allows one in-put point being connected with several output points. Thismakes the vertical electrical connection extremely flexible,opening up new, more ergonomic design possibilities formedical devices.

MED:MED: What does the production process look like?

Jens Trötzschel: Automated batch or wafer scale processes al-low integration of a great number of electrical channels in ext-remely small surface areas. Computer controlled machinespunch tiny holes in a thin, “greentape“ ceramic film whichthen gets filled with the CerMet paste in a screen printing pro-cess. The number of feedthroughs - called vias - depends onthe diameter and spacing between the individual vias. Viaswith diameters between 100µm and 800µm and spacing ran-ging from 250µm to 150µm are currently being developed.Depending on the design of the device, densities of up to1,000 vias per square centimeter can be realized.

MED:MED: Can you give us examples of applications that arebased on this technology?

Jens Trötzschel: Examples are cochlear implants or micro im-plants that interact with each other and are placed in differentlocations in the body. At the same time, we can improve exis-ting treatments anddevelop new therapies that were previous-ly impossible. Heraeus is also active in the INTAKT programsupported by Germany’s Federal Ministry of Education andResearch (BMBF). This project is all about demonstrating newways and possibilities for interaction between humans andimplants.

MED: MED: Heraeus presented the CerMet technology to thepublic for the first time at a tradeshow in 2015. How has thematerial been accepted in the market since then?

Jens Trötzschel: Our technology received great interestthroughout the industry and we currently have developmentorders for specific projects in theworks. There is awide varietyof future applications in the area of retinal implants and inter-faces with nerves or the brain. An extremely high number ofcommunication channels are needed for suchuse.Retinal im-plants currently have around 60 channels, but the next gene-ration will have far more. Neural interfaces have 80 to 100channels today, while future devices will have around 1,000channels. The long-term goal is 10,000 channels to give doc-

The CerMet-Technology allows the miniaturisation of implants

46



AEMtec GmbHGermany

James-Franck-Straße 1012489 Berlin

Phone +49 30 6392 7300Fax +49 30 6392 7302

[email protected]

Microsystems for medical devices, wearables and portablesAEMtec, a leading European provider of hybrid microelectronic and optoelectronic assemblies develops, qualifies and produces complex micro and optoelectronic modules through to com-plete systems for medical applications, such as:

■ Wearables ■ Handhelds ■ Diagnostics ■ Medical Equipment ■ Imaging and Acoustic Systems ■ Laboratory Diagnostics.

Highest Quality and Innovation

AEMtec meets the highest quality assurance and quality management systems including, ISO 13485, EN 60601 and ISO 14971. In addition, AEMtec thouroughly understands the high quality requirements of the Medical industry and knows how to satisfy these requirements by 100 %. In a cleanroom environment up to Class 100 we are scalable producing prototype quantities through to high quantity serial production. AEMtec also places great emphasis on process development work. Diverse concept

developments, exact specifications, feasibility and systematic risk analysis (FMEA) form the basis for safe and reliable results.

From Wafer to Module assembly

By offering a high standard of technology equipment (UBM, SBA, Dicing, COB, FC, SMT, Box-Build) and process services, our Customers benefit from reduced supply chain time, risk and cost. Assuming responsibility for the entire production chain and full product quality enables potential errors to be more easily identified and eliminated and production processes to be adjusted and improved accordingly. Serving individual needs we use the latest CAD tools and simulation software always with an eye on every detail.

Take advantage of our unique portfolio of services and assembly technologies for your innovative product. Together let us take advan-tage of our unique portfolio of services and assembly technologies for your innovative medical product.

Company Profile

tors a better picture of the human nervous system. They canalso apply such signals for many other purposes such as parti-ally restoring body functionality of paraplegics.

For established devices such as pacemakers, the wire basedfeedthrough technology is still sufficient. But even producersof these devices are coming to us to learn more about CerMet.

For such applications, the technology is appea-ling primarily because of its reliability, but alsobecause CerMet-based components enablethe largely automated assembly of active im-plants and therefore potentially represent sig-nificant cost savings.

MED: MED: Mr. Trötzschel, we’re looking for-ward to seeing your team’s developments in thefuture. Thank you for speaking with me today.

Carola Tesche conducted the interview

The CerMet-Technology makes it possible to realise a multitude of conductor trackswithin the smallest space

CONTACT

Heraeus Medical ComponentsHeraeusstr. 12-14D-63450 HanauPhone +49 6181 35 45 10www.heraeus.com

47



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Optec

GmbH

Fiber optic components of medical UV-lasers previously only had ashort lifespan. Themain reason for that was the so-called solarization.Fibers featuring a permanent solarization resistance are now available.

Optical Fibers withLong-term UV-ResistanceOptical fibers are often crucial for the construction of me-

dical lasers. By permitting to focus the laser beam tightlyand afford flexible guidance, they create ideal conditions

for delicate surgical applications, especially in the areas of oph-thalmology and dermatology. Their short lifespan, however, hasso far been a distinct disadvantage. Customary quartz glass fibersquickly lose much of their transmission quality when exposed toUV light. Especially the coupling of UV-C-light with wavelengthsof 200 to 280 nm causes a rapid deterioration process. This hap-pens due to a physical dimming effect called solarization. The ef-fect is caused by the separation of silicone oxide bondswithin thequartz glass, which are in turn induced by UV-photons. The sepa-ration causes the creation of so-called defect centers, where theglass absorbs the UV-radiation and gradually darkens in the pro-cess. It turns gradually “blind“, until it is no longer capable totransmit sufficient quantities of light. Since the effect cannot bereversed, the only option is to change fibers on a regular basis. De-pending on the type of laser system, that may involve extensivetechnical efforts and can also become expensive if theUV-laser isused on a frequent basis.

Absorption of UV-Light was – at Best – Delayedso Far

Fiber optic technology previously failed to effectively stop thattechnically and economically unsatisfactory aging process. So-larization has been the subject of intense research for quite so-me time and leading fiber opticsmanufacturers have repeatedlytried to develop solarization resistant fibers. Without much inthe way of satisfactory results. One method for effectively con-taining the absorption of UV-light, the so-called defect passiva-tion, is actually very well known. In the course of that procedure,the separation of the silicone oxide bonds is countervailed by asaturation with hydrogen ions in the defect centers. The core ofthe optical fiber is thereby charged in a pressure chamber – athigh temperatures and a gas pressure of up to 100 bar – with ex-cess hydrogen atoms (H2) which will provide the required pas-sivating particles later on. The procedure actually blocks the ab-sorption of UV-light, as demonstrated by numerous studies.

Despite its high degree of efficiency, the defect passivation me-thod has only partially established itself in practice. The darke-ning effect was initially blocked efficiently. That result was notmaintained permanently, however, since the hydrogen atoms dif-fused out of the core eventually. As a result, solarization resis-tance was gradually lost, since it was only possible to achieve adelay of the darkening process. Some manufacturers thereforeabandoned the defect passivation in favor of an attempt, to redu-ce the number of defect centers during the drawing process of thefibers. Since that number cannot be reduced to zero though, evenwith that method, solarization remains an issue. Temporary de-fect passivation actually turned out to be more efficient.

A New Approach

How about, if it were possible to stabilize the defect passivati-on process? Fiber optics specialist CeramOptec pursued thatquestion. Based on the idea, to provide a permanent supply ofthe saturating hydrogen ions, the biolitec subsidiary was loo-king for ways to block the gradual ion diffusion. The solutionturned out to be a carbon coating of the fiber jacket, appliedduring the drawing process of the fiber. This coating seals thefiber hermetically at regular application temperatures and on-ly opens to diffusion at temperatures in excess of 150°C. Dueto these particular characteristics of the coating, a stable de-

CeramOptec UV NSS fiber

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www.med-eng.de

MEDMaterials

fect passivation isnow possible. The fi-ber is charged withhydrogen ions in thepressure chamber atmore than 150°C anda gas pressure of ap-proximately 70 bar.As soon as it leavesthe pressure chamberand the temperaturesinks below 150°C,

the passivating ions remain trapped behind the carbon layer.That way, enough particles remain available for the saturationof potential defect centers in the long run as well.

The coating technique was applied for the first time in the Op-tran® UV NSS fiber. It consists of a non-doped quartz glasscore, a fluorine doped quartz glass jacket aswell as a high-gra-de polyimide jacket, which protects the carbon layer againstdamages. The jacket features a tensile strength of 70 kpsi (ki-lo-pound per square inch) and remains stable when used formobile applications, without compromising the flexibility ofthe fiber. Based on these product characteristics, lab tests es-tablished an extraordinary high solarization resistance: afterinjection of UV-C-light with a wavelength of 214 nm for morethan 100 minutes, an Optran® UV NSS fiber with a length oftwometers still showeda transmission of 85percent of the ori-ginal transmission value, as well as an attenuation of less than1 dB/m. Long-term observation showed no decline in trans-mission values either. Neither did they reveal traces of hydro-gendiffusion: Variations in theH2-concentration of the quartzglass remainedwithin the specified errormargins during a13-month observation aswell and can be ascribed almost certain-ly to the interaction of the hydrogen ions with the radiation af-fected defect centers. Claiming long-term solarization resis-tance is therefore fully justified.

Long Lifespan, Versatile Fiber Designs

The Optran® UV NSS fibers constitute a fiber optic componentwhich is suitable for all medical UV-laser applications and – forthe first time – feature an extended lifespan. Their applicationsignificantly reduces technical exertions related to changing fi-bers and leads to a sustained cost reduction. The fibers are avai-lable ex-factory with numerical apertures (NA) between 0.12 and0.28, aswell as core-jacket ratios of1:1.06up to1:1.4. Individu-alized fiber designs can be provided upon request. Which versionis best suited for yourrequirements, shouldbe initially determi-ned as part of a perso-nal consultation andasserted as part of antest-run in the fiber lab.

Magnetic Self-MatingConnectorsMagnetic connectors of Rosenberger – with self-locating and self-locking function – are ideally suited for medical and hospital environment applications: e.g. patient monitoring, communication and nurse call systems, bedside entertainment and surgical equipment such as surgical helmets and protection.

Product features § Easy and fast connecting § High number of mating cycles > 10,000 § Break-away function prevents damages by

unintended disconnections § Shock and vibration proof § Current 500 mA up to 40 A

Magnetic Self-MatingConnectorsMagnetic connectors of Rosenberger – with self-locating and self-locking function – are ideally suited

MEDICAL & INDUSTRIES

www.rosenberger.com/m&i

1000

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Typische Optran® UV NSS Faser Typische Optran® UV Faser

Modifications of the transmission of a2m fiber when irradiated with 214 nm.

CONTACT

CeramOptec GmbHSiemensstr. 44D-53121 BonnPhone +49 228 97 96 70www.ceramoptec.com


MEDDevices Operating Systems

Images:D

ATAMODULAG

PCAP - a Cure for theMedical FieldTheprotective cover glass surface of projective capacitive

(PCAP) touch panel not only offer cosmetic advantage interms of a more appealing look but also eradicates the

problem of dirt collecting edges found in other touch technolo-gies. Touch technology, such as resistive touch panel; comewith a gap of few millimeters along its perimeter. Cleaning thetouch sensor surface simply result in dirt collecting into the ed-ges. To prevent this, resistive touch panels are sometimes co-veredwith decorative film to create a continuous surface free ofgaps. Adding an extra film to an already functional touchpanelssimply accrue to the manufacturing cost and effort. Moreover,resistive touch panel are prone to durability issues due to thelack of sturdy surface that make it vulnerable to impacts andscratches. The silicone or rubber sealants around its edge dis-solve in alcohol and other harsh solvents, used frequently ascleaning agents in medical field. Besides these challenges, re-sistive touch panels are still prevalent in medicine due to theease of operation with gloves and guaranteed reliability underconducting solvent such as saline water at the surface.

However, resistive panels offer rather limited touch functionali-ty. Multi-touch operation is easy to incorporate into a PCAPtechnology which can be rather challenging in a resistive tech-nology. Moreover, cover glass is not just an additional featurebut rather a vital component of a PCAP stack-up rendering it

significantly better in scratch and impact resistance. ThePCAPpanel is generally front mounted onto a housing making thecomplete the touch-display unit impermeable to liquid and re-sistant to dust. DATA MODUL PCAP products, marketed undereasyTOUCH PCAP solutions, offer not only all the generic ad-vantages of modern PCAP design but also offer operation feasi-bility with gloves of various thicknesses and materials. Moreo-ver, reliable operation under the influence of different liquidcontaminants on the PCAP surface has been realized. The laterfeatures were, until recently, limited to resistive touch panels.

Fluids – the Big Challenge

When it comes to medical application, the biggest challengefor a PCAP touch technology is not only ensuring utmost per-formance with different kinds of gloves but also ensuring opti-mal performance under the presence of highly conducting sol-vents or bodily fluids at its surface. These liquids are wides-pread in medical application in the form of alcohols, salinewater (0.3% to 1% salinity), ultrasound gels, blood and otherbodily fluids. Almost all or most of these fluids are conductingto a certain extent and hence influence the electrical fieldaround the PCAP. The un-touched or base capacitance regis-

A consistant and easy to clean glass surface is one of the advantagesof the PCAP-Technology

PCAP touchscreens are com-monplace in industry. In themedical environment, however,this technology is still usedwithreservations. Resistive and inf-rared-based touch units are of-ten also in use at present. At thesame time, the advantages ofPCAP solutions - particularlyfor medical devices - are abun-dantly evident.

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tered in the touchcontroller would nolonger hold true.False inputs orghost touches areregistered in thetouch controllerdue to the interfe-rence fromanunex-

pected conducting material at PCAP„s electrical field proximity.A normal touch eventwould not be recognized due to this externalinterference. However, recent progress in PCAP controller de-velopments has changed the scenario. Previously, this challengeof ghost touch associated with conducting liquid was avoided bywiping the solvent across the screen. This reduces the change inthe base capacitance by distributing the field over larger area andkeeping the base value within the error margin. The advances inPCAP controller, attributed to its improved signal processing al-gorithms, have made working under droplets of various liquidspossible. The algorithms are able to mask films of water or othersolvents on the user interface and detect them as interference.

Measurement Methods in PCAP Technology

PCAP technology works by measuring the capacitive couplingor capacitive changes induced in its inherent electrical capa-

citance by an object or stylus. The changes in capacitance arerecorded by an electronic assembly – the touch controller. Thetouch controller translates this touch event into an X and Ycoordinate to detect the touch position.

Two types of capacitance exist in a PCAPdesign, which resultsin to main measurement methods. The design consists of amatrix of X and Y electrodes. A capacitance coupling existsbetween these electrodes and also between the individualelectrode and the ground. Mutual-capacitance works by mea-suring a decrease in capacitive coupling between the X and Yelectrodes by a touch event. Thismakes the detection ofmultitouch events possible. Self-capacitance works by measuringthe increase in capacitive coupling between electrode and theground. As the fields of the electrode extend above the coverglass surface, self-capacitance helps to detect a conductingobject further away from the touch panel - thus a finger cover-ed by a glove is detected. The effect of liquid on the PCAP sur-face is tricky for each of these sensingmechanisms.Whenwa-ter layer is present,mutual capacitance detects an increase incapacitive coupling between the electrodes which is not a ty-pical touch event. Self-capacitance detects a more than ex-pected increase in capacitive coupling with ground at a sud-den presence of liquid. Signal processing of the raw data fromboth of thesemeasurementmethods and subsequent analysisallow for detection of water accumulated on the screen. Allo-

Full operability

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Clamping elements Couplings Made in Germany

Tel. +49 6022 [email protected]

Waterproof.

The EWC shaft coupling and the ECR torque limiter are made entirely of stainless steel and comply with the strict hygiene regulations of the food, drug and pharmaceutical industries. We are happy to advise you!

www.m

o-ka.net



wing glove operation, detecting or following a touch event inwater (touch point tracking) demand intensive controller con-figuration adjustments. Hence, it is extremely imperative towork in close collaboration with the end customer to defineand understand the exact touch functionality needs.

No PCAPWithout a Glass Surface

Glass is the USER interface for the PCAP technology. The ra-pid adoption of PCAP technology in several application areas,particularly medical, has increased the demand in antibacte-rial glass surfaces with low toxicity taking into considerationenvironment, health and safety hazards. Analysts at the mar-ket research company Technavio forecast a growth with CAGRof 7% until 2020 in the global antibacterial glass market.

Antibacterial glass provides a core argument for the use ofPCAP technology inmedicine inparticular. Antibacterial glasseliminates 99 percent of the bacteria found on horizontally orvertically positioned glass owing to the antimicrobial effect ofsilver ions incorporated in the glass. The silver ionsprevent thespread of fungi and can be used in environments where stricthygiene requirements prevail and in areas where bacteria andfungi are likely to dominate.

DATA MODUL has adopted, Planibel AB, a patented antibac-terial glass free of nano particles for its HMI products. Thisproduct fromASAHIhas silver ions incorporated into the coverglass surface through direct diffusion of silver ions into theglass making any additional coating superfluous. The glass isconsequently extremely low-maintenance, easy to clean andretains its antibacterial properties even after cleaningwith ag-gressive chemicals. Other conventional float glasses are trea-

ted with nano-silver particles (spray finish orcoatings) to achieve similar antibacterial ef-fects. Other possible direct antibacterial glassvariants include lacquered glass, mirror glassand laminated glass.

Antibacterial glass is currentlymost commonlyused in hospitals owing to the strict official re-quirements for sterile environments and hygie-ne, since there is a higher possibility of thegrowth of harmful microbes in this environ-ment and illnesses can so easily be passed onto patients, staff and visitors. The demand forHMI devices in particularly sensitive clinicaldepartments such as geriatrics, intensive care,oncology, infant wards, hematology, isolationrooms, and sterilization room is immense.

The inexorable advancement of PCAP technolo-gy in industrial market is hard to miss. Criticalrequirements in medical application have alsobeen the key driver of this progress. Along withantibacterial surface, anti-reflection (AR) and

anti-fingerprint (AF) surface treatments are widely demandedcover glass features in medical application. AR surface treat-ment improves transmission and reduces reflection. AF surfacecoating counteracts finger prints. Those additional features of-fering higher contrast and readability, necessary in medicalimaging.

Touch sensing technology such as haptic, gesture and forcetouch technologies, for example, the current DATA MODULforce touch sensor are among various features that can beused alongside a PCAP touch sensor to widen the market re-ach of PCAPapplications. Introducing redundant features in atouch panel, through additional control functions, help estab-lish a secure functionality of the medical device in criticaloperating environments such as in emergency roomor intensi-ve care unit. The flexibility of a PCAP technology, the constantdevelopments surpassing barriers and new materials offer end-less possibilities to the demanding medical visual solutions. Across over to PCAP from resistive technology is anything but abitter pill for the medical field.

Author:Richa Sharma, Product Marketing Manager, Touch,DATAMODUL AG

Influence of water on the measurement on the PCAP touch

CONTACT

DATAMODUL AGLandsberger Str. 322D-80687MunichPhone +49 89 56 01 70www.data-modul.com

52


MEDDevices Positioning Systems

NewMaterials –New ApplicationsThe company now employs nearly 3,200 people worldwide.Assembly centres have been established in 14 of the 35countries where branches exist, among others, in the US andChina. The company headquarters in Cologne is the largestsite with almost 1500 employees. Ulf Hottung, head of themedical technology industry, spoke to the editors.

MED: The igus® GmbH produces machine elements made ofhigh-performance plastics, which are used in the field of mo-vement. The product portfolio includes over 100,000 soluti-ons from stock. How do you ensure the delivery of preciselywhat the customer needs?

Ulf Hottung: It is very important to work closely with the custo-mer. This is the only possible way to understand his or her in-dividual technical challenges. Therefore, we also support ourfield sales with industry managers who are particularly wellembedded in the respective market and its specific require-ments. In this way, we are able to submit specific, concreteproposals for solutions as to how the „motion plastics“ can beused to solve the customer's tasks.With our high-performanceplastics for motion, we want to fulfil our „plastics for longerlife“ claim, so that the customer saves cost and improves thetechnology (at least one of the two). Be it plain, spherical, ballor linear bearings or energy chains and cables, individually oras a system.

MED: Plastic is found in many different areas. Is the use ofplastic a sure-fire seller?

Ulf Hottung: During vocational training, metallic solutions areoften still in focus and there is then a digression to the „othermaterials“ such as technical plastics. Sometimes, designersuse metal bearings because they have always done so. Forigus®, it is therefore important to constantly demonstratewhathigh-performance plastics can achieve and offer in terms ofadvantages, be it at specialist trade fairs or in-house exhibiti-ons or directly at the customer's premises. A change has beenincreasingly taking place, by which in many industrial sectorsplastic products for the motion are becoming the standard ra-ther than the exception, such as in energy supply in machinetools or on crane systems; places where the importance of ro-bustness and corrosion resistance have long been recognised.Likewise in vehicle construction, where every gram is valuab-le, or in food technology, where the best possible cleaning

quality of themachines has to be ensuredwithout subsequentmaintenance (lubrication).

MED:Plastic is also suitable for themedical technology sector.One only has to think of disposables. These are well establis-hed. At the same time, manufacturers of medical systems arelooking for new options for their systems. Mechanical soluti-ons have to fulfil strict regulations. How do you succeed inconvincing customers of plastics technology?

Ulf Hottung: The innovative power of igus® is reflected inhundreds of new products and solutions every year. We alsohave decades of experience in the field of machine technolo-gy. This helps. Ultimately, for example, themovement of an X-ray machine does not necessarily differ from themovement ofanother machine. The difference is rather to be found in thenumber of movements where, compared to a production ma-chine, the medical device performs only a fraction of the mo-vement during its lifetime, but has to function absolutely reli-ably from day 1. This provides a wide range of potential appli-cations for maintenance-free plastic technologies in themovement elements or the cable guidance and also in the pro-duction of medical products.

Founded in 1964, igus® GmbHshowcases the classic careerof a medium-sized company.At the start, the companyfounder Günther Blase instal-led an injection moulding ma-chine in a backyard garage inCologne to produce customer-specific plastic parts.

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MEDDevices Positioning SystemsImage:gus®

GmbH

MED: Do you have examp-les?

Ulf Hottung: The manu-facturing technology nee-ded for medical productswith high volumes andcomplicated, intertwiningmanufacturing processesmust be strictly observedand not interrupted. Forthis sector we now haveself-monitoring energychains and cables. Withthis technology, which

can also be easily retrofitted in an existing production line, awireless module simultaneously monitors several energychains and cables for defects and wear, and thus prevents un-scheduled downtime.

In general igus® products can be found virtually everywhere inmedical technology. From laboratory equipment to prosthe-ses. Plastic bearings, for example, are likewise required in pi-petting machines, the scissor structure of a patient couch, ahospital bed or even a knee prosthesis.

We modify plastics according to the requirements. The basepolymer material, which has the properties suitable for an ap-plication such as temperature and material resistance, is se-lected from the so-called plastic pyramid. The next step is tofurther improve certain properties. Just in the same way as wehave done for our more than 40 iglidur® plain bearing materi-als, which are already successfully used inmany applications.For example, the antibacterial bearing material iglidur® ABhelps to reduce the germ load in poorly accessible bearingpoints. The iglidur® plastics enable maintenance-free slidingfriction due to the addition of fillers and reinforcingmaterials,because tiny lubricant chambers are found homogeneouslydistributed in the material permanently reducing wear andfriction, and even after contamination or cleaning the lubrica-tion of the bearing point is „automatically renewed“. A decisi-ve advantage: 80% of machine failures worldwide are causedby a lack of lubrication and inadequate lubrication or by con-tamination of the lubrication.

MED: How do you stand out from the competition?

Ulf Hottung: We strive to find the most cost-effective solutionthat works for the customer. Tomake this possible, we current-ly house the industry's leading test lab at our Cologne location.Through the many real tests performed in an area of 2,750square metres, we gain precise information about the respec-tive product, for example, the service life in different environ-ments. This allows us to provide reliable information and ulti-mately gives the user the reliability he or she needs. The testresults are incorporated in our online tools. This enables the

customer to quickly calculate and configure his or her productor system.

MED: What are the technologies focused on at present byigus®?

Ulf Hottung: An interesting area is low cost automation - alsoinmedicine. For this we offer the robolink® robot joint kit. Thesystem allows the individual configuration of a complete sys-tem of robot joints. It is thus not only possible to select the in-dividual armsegments to the required lengths, but also the ac-cessories suitable for the particular application. The customercan request the system directly or order online.

We ourselves use robolink® systems in our energy own chainassembly. Here, a great deal of manual work is normally re-quired, since, for instance, the interior separation of thechains is individually designed and assembled. In other pla-ces, however, automation is possible. For standard energychains, pick & place tasks, the insertion and compression ofthe chain links can be automated easily and economicallythanks to robolink®.

Of course, this robot will not become a surgical robot, but it isconceivable that this robot will assist elderly and sick peopleand thus relieve nursing staff. Or that it will be used in the fieldof MR diagnostics with slight modifications. There are alsoprojects in which standard procedures, e.g. the preparation ofsurgical equipment for the treatment, can be automated, sin-ce the systems are cost-effective and flexible enough to justifya temporary use and still ensure reliable and efficient work-flows.

But even inexpensive lubrication-free and maintenance-freelinear technology modules can easily and cost-effectively im-plement monotonous standard routines in laboratories, suchas redistribution of liquids, application of nutrient solutionsand so on, that is, manual tasks for which time requirement ishigh.

MED: An interesting approach. Thanks for the informative dis-cussion and wish you continued success.

The interview was conducted by Carola Tesche

Ulf Hottung, Industy Manager Me-dical, igus® GmbH

CONTACT

igus® GmbHSpicher Str. 1aD-51147 KölnPhone +49 2203 964 90www.igus.de

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MEDDevices Systems

MIKROP AGSwitzerland

Industriestrasse 229301 Wittenbach

Phone +41 (0) 7 12 92 10 [email protected]

mikrop.com

mikrop ag – your supplier for miniaturized quality opticsAs a worldwide leader in technology Mikrop offers high-precision optical systems in the � eld of miniaturized medical devices. Since 35 years, we develop, manufacture and mount highly complex, miniaturized optical components and assemblies. Mikrop is one of only few companies worldwide to manufac-ture high precision lenses and assemblies starting at diameters of just 0.30 mm.

Mikrop is the source for Swiss precision miniature optics serving all high-tech mar-kets. Our lenses, objectives and optics are amongst the smallest imaging devices in the world.

Our Products and Services Include

Integrated Complete Solutions: Optical and mechanical design, production of prototypes, serial production and assembly

Optical Assemblies: Multi-element assemblies comprising lenses, prisms and housings, cemented compact optical groups

Spherical Lenses: All types of single lenses, doublets and triplets, rod lenses, miniaturized lenses, lenses with conical edge

Micro Objectives

for CMOS / CCD camera formats from 1/4” down to 1/18”, custom designed, with Field-of-Views from typ. 30° and up to 210°

Micro Camera Omnivision OV6946 Sensor

New frontiers in miniaturized imaging– ready assembled camera head– brilliant high-resolution image– customizable objective design

For Customers and Applications in

■ Endoscopy ■ Micro lmaging ■ Micro Sensors

Company Pro� le

Omnivision OV6946 Sensor

■ Medical Engineering ■ Machine Vision ■ Micro Cameras

THE INTERNET FINDS TOP-LEVEL SUPPLIERS

ORDERFOX.com, the Internet of the CNC industry, is the world“slargest CNC database providing CNC manufacturers and buyers

with new business opportunities. CNC manufacturers can search for andfind both local and global CNC jobs for FREE – buyers can place CNC jobson the platform, as well as update and optimise their network of suppliers.

CNC parts for the medical technology industry require the highest level of

precision down to themicron, regardless ofthe materials. Buyerswithin the medicaltechnology industryneed CNC manufactu-ring partners that spe-cialize in specifictechnologies and usethe most technologi-cally advanced machi-

nes. ORDERFOX.com is a key resource for the medical technology industry,as the platform not only suggests the proper partners with the right techno-logies and know-how based on their company profiles, but also provides apathway for tendering offers.

Buyers can optimise and simplify their processes and search globally fornew suppliers For buyers, ORDERFOX.com provides a range of contacts tomeet any requirement – from mass producers to highly specialised manu-facturing firms with niche expertise. This enables buyers to find highly qua-lified suppliers both locally and globally, and in doing so, update and opti-mise their supplier networks decisively. ORDERFOX.com provides buyerswith a wide range of technical features in which they can utilise all of the

advantages of the digital tendering processes. On ORDERFOX.com, tende-ring is simple, efficient, quick and precise.

Timesaving Features for Tendering

Usability is one of the guiding principles of ORDERFOX.com, and this startswith simplifying the input of job data. A vast amount of details can be inputthrough timesaving multiple-choice processes or checkboxes; e.g. materi-als, technologies, industries, certifications and even GTC. However, thesmart filter tools on ORDERFOX.com take ease of use to the next step. Buyerscan set the geographic range, even varying it from job to job, and filters forexclusive partners and company blacklists help to refine the target group.Private mode can also be activated to hide the contact information andrepresentatives of a company, if a company wishes to remain anonymous onthe platform. www.orderfox.com

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MEDDevices Positioning Systems

Customised Solutionfrom the Standard RangeSuitable products and innovative, competent manufac-

turers are required for this. HASEKEGmbH&Co. KG iscertified in accordance with DIN EN ISO 9001 and

DIN EN ISO 13485 and has been the leading manufacturerand developer of carrier and suspension arms for many years.

The company has an edge ofmany years in the sector with res-pect to technology and, with the height-adjustable HMA Lift1000, HMA Lift 501 and 551, HMA Lift 220, HMA Lift 230,HMA Lift 150 and HMA Lift 20 carrier arm systems alreadyoffers several, extremely light precision carrier arm systemswith load bearing capacities from 1.5 to 150 kg which areusually unique in medical technology.

Traditionally, HASEKE not only focuses on “leading edge“functions and the design, but also on ergonomic aspects in allareas of application. In many cases, the products of the OEM,which is well-established in Westphalia, are not visible on themarket, but are integrated into applications by system provi-ders of complex operating rooms or medical equipment deve-lopers. Many internationally renowned companies now bet onquality products from HASEKE when it comes to the topic of“intelligent movement“. Included in the HASEKE productportfolio are the HMA Lift 220 and the HMA Lift 230mainte-nance-free spring arms for common standard applications.

The HMA Lift 220 has a load-bearing capacity of 1-21 kg anda vertical stroke of 1174mmand theHMALift 230has a load-bearing capacity of 23-30 kg and a vertical stroke of 1130mm, so these models are excellently suited for suspending,e.g. operating lamps, heat radiators or small monitors and canbe easily integrated into new and existing applications viastandard interfaces.

Newly developed3-pin230V/16A rotary connectorswith a pa-tent pending are of course, part of the comprehensive range ofaccessories. The new feature here is that the connections onthe rotary connector do not require any soldered connectionsand can therefore be quickly and easily connected using stan-dardized connection cables.

In order to expand the area of effect, carrier arm systems, such asceiling driving carriages, ceiling rail systems with cable manage-ment, wall and ceiling connections with internal cabling, centralaxes and driving carriages as well as monitor mounts, pre-as-sembly sets and system pre-cabling can be provided by HASEKEfor all lift systems. Even the installation of hydraulic stem lockingsystems or electromagnetic “one touch“ brakes or a special coa-ting on the carrier arm components for hygienic areas are inclu-ded in the systems delivered by HASEKE every day.

The carrier arms have to meet all requirements, at all times, with thehighest precision andmust be easy to clean.

Continuously adjustable carri-er and suspension arms havelong proven indispensable inmany medical areas. They canbe used to optimally positiondiagnostic and therapeutic de-vices as well as control moni-tors and other medical ele-ments with minimal physicaleffort within a remarkable radi-us of action.

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MEDDevices Positioning SystemsImages:H

asekeGmbH

&Co

.KG

But HASEKE not only offers the optimum solutions for wallandceiling-supported systems. Thequality products fromHA-SEKE are also installed in medical equipment such as micro-scopes, ultrasound and sono-graphy equipment, dental chairsand much more. Whenever ergonomics and the easy positio-ning of loads in open spaces without tiring is important.

The HMA Lift 150 rotating lift was developed for navigationcameras in the field of implant surgery. This is the first carrieroffered on the market that can move a device on a vertical arcwithout having to compensate for the mass of the up to 10 kgsuspended component with a counterweight. Due to the HA-SEKE module system, the different series can be configuredand combined to depict nearly any medical application case

using standard products from HASEKE. This means there areno cost-intensive special solutions and long delivery times wi-thout you having to forgo the comfort of customer-specificpaint or coatings.

Of course, in addition to the standard range, customised spe-cial solutions tailored to the customer can be created not onlywith respect to the various system lengths of the components,but also a wide variety of special solutions, e.g. in the area ofload-bearing capacity, the stroke range or connection to custo-mer-specific devices. To this end, HASEKE also continues tostay in competition with disproportionately large R&D depart-ments in Porta Westfalica.

Themanaging partner of HASEKE, Dipl.-Ing. Uwe Kunitschke,is already looking beyond the present: “Like with all moderntechnologies, we are far from reaching the end of the develop-ment line. Our mission is to recognise early on what compo-nents will be neededin the future and tohave the correspon-ding products readyfor delivery when thefirst customer asksfor them“.

Proportional Flow Control Valve

for Pneumatics

• 2 ways normally closed (NC)• Proportional characteristic current – fl ow• Pressure range: 0-8 bar• Overload pressure: 16 bar• Flow: depending on size up to 200l/min• For oxygen and neutral gases• High switching life time• Short actuating time• FDA compliant

D-87700 Memmingen ● Tel.: +49 8331 10 40 ● Mail: [email protected]

Responsible for the power supply in the lift: 360° rotary connectorwith solder-free quick-release connection, patent pending

Female connector

CONTACT

HASEKE GmbH& Co. KGSandtrift1D-32457 Porta WestfalicaPhone +49 5731 760 70www.haseke.de

57


MEDDevices Imaging Techniques

A gait laboratory was established - the first of its kind worldwide to useits image-based system. This technology allows experts to diagnosegait disorders more quickly and easily and to plan better treatment.

Walk Well

The system was designed by the company Simi RealityMotion Systems GmbH, based in Unterschleißheim,which hasmore than 20 years' experience with systems

for movement and behaviour analysis and occupies a leadingposition in this field. The video footage for analysis is capturedby high-speed cameras manufactured by MATRIX VISION inOppenweiler.

The laboratory is impressive. As soon as you step foot in theroom, you notice the bright halogen spotlights in every corner,illuminating a marked walkway. Patients pace up and downthe 15 m-long track with special markers attached to variouspoints on their bodies. At the same time, a screen allows you towatch as curves and graphs take shape in a diagram: the pati-ents' body axes are simulated in real time in a three-dimensio-nal reconstruction. In addition, eight high-speed cameras re-cord the patients from the side, in front and behind. The foota-ge is shown on the screen. It is then used at a later treatmentstage to provide assistance in accurately tailoring the treat-ment to the patients - whether during the planning stage in theoutpatient department, directly in the operating theatre du-ring a potential operation orwhenproducing custom-fit aids inthe hospital's internal orthopaedic workshop.

Advantages of the Image-Based System

The image-based system lends the new gait lab a special ad-vantage in comparison with traditional infrared-based sys-tems. Infrared-based technologies only measure the coordi-nates of the markers and reconstruct a schematic 3D modelusing the data they obtain. To achieve a good result, you needahighnumber ofmarkers. Formanypatients, especially child-ren or patients with Parkinson's, the lengthy process of atta-ching the markers can be very straining.

The image-based process, on the other hand, also shows thegait pattern of the patient in real time, as it uses high-speedcameras as well as artificial 3D reconstruction. In addition tousing individual (and far fewer) markers in comparison withinfrared-based systems, the image-based process also makesit possible to perform a markerless gait analysis using a me-thod known as silhouette tracking. Thismeans that there is nolonger a need to attach markers, making the gait analysis pro-cedure altogether quicker and easier to carry out. While thehuman eye is limited to around 20 images per second, thehigh-speed cameras capturemany times that number. This al-lows experienced orthopaedists to identify causes and effectsof a gait disorder even if clinical investigations do not allowthem to draw sufficient conclusions. Although the amount ofdata collected by theHDcameras is enormous, it is possible tosave this data and use it in a day-to-day clinical setting, as sto-rage options have now become quicker and less expensive.

Consideration when Selecting a Camera

Simi already had concrete ideas for the camera during the de-velopment stage. They decided that the camera needed to beas robust as it was handy with resolution of at least 1920 x1080 pixels and full HD capability. As the planned length ofthe walkway was at least 15m, distances of at least 7.5mbet-ween the analysis PC and the cameras would need to be over-come, if the analysis PCwere to be placed in the centre. Giventhat, when using USB 3.0-based solutions, interference-freetransfer can only be guaranteed if using cables of less than 4

Innovative diagnostics enables more individualized therapies

58


MEDDevices Imaging TechniquesImages:M

atrix

Vision

Gmbh

mlong, Simi took the decision to deploy a network-based solu-tion. However, it was noted that, when using eight GigabitEthernet HD cameras, the net bandwidth of approximately120MB/s available for Gigabit Ethernet would soon be excee-ded: 8 x 1920 x 1080 x 30 (images per second) x 8 (bit imagedata) = approx. 500 MB/s. Simi considered that this problemcould be solved by bundling the Gigabit Ethernet cabling withsufficient image storage buffer in one camera and found theright solution in the mvBlueCOUGAR-XD range from MATRIXVISION. The XD range consists of Dual-GigE cameras whichcanbundle twoGigabit Ethernet cables into one via link aggre-gation and therefore provide net bandwidth of approximately340 MB/s. In addition, the cameras offer image memory of256 MB which, when configured correctly, compensates forthe lacking bandwidth.

There was then only the right model left to find. As, on the onehand, CCD sensors are too expensive, and, on the other, theyare set to be phased out of production by 2025 at the latest, aCMOSsensorwasneeded.Additionally, a global shutterwas ofcourse required due to the movement in the image. The MA-TRIX VISION portfolio presented us with the solution: themvBlueCOUGAR-XD104dC, which uses the Pregius SensorIMX174, manufactured by Sony. With a resolution of 1936 x1216 pixels, this supports full HD, has amaximum refresh ra-te of 105 Hz and is a global shutter sensor.

Simple Integration and Excellent Image Quality

Simi was impressed by the Sony sensor. It sets new standardsin the fields of dynamics, speed, quantum efficiency and noi-se, and showed excellent results. Integrating the camera andestablishing the network were completed quickly, confirmingSimi's decision to use the MATRIX VISION camera. And itdoesn't stop there: the doctors on site are also impressed withthe new lab. Usingmovement analysis, treatments can be fur-ther refined andmatchedmore accurately to the patients. Forexample, amonitor in the operating theatre allows the doctorsto see the gait pattern once more before performing surgery.The orthopaedic workshop can make its aids more individua-lised to more accurately meet the needs of the patients andthe gait pattern can even be transferred into the outpatient de-partment. What's more, it is also possible to assess the suc-cess of a treatment more independently afterwards andmoni-tor that success in the long term. Better than what would bepossible with the human eye.

Conclusion

Whether it's dental cameras, endoscopes or cameras to beused in ophthalmology or dermatology, industrial cameras arenow an integral part of many areas of medicine. They make itpossible to carry out remote diagnoses and robot-assisted sur-geries, they document diagnoses andmake things visible thatwould otherwise have remained hidden.Many doctors are gra-teful for the new opportunities offered by a digital eye. Yet thisimage-based system does not just come in useful in orthopae-dics; in sport, movement analysis also has the potential to ext-ract those decisive milliseconds by optimising your move-ments. In a year that has seen the Rio Olympics and the manyrecent doping scandals, it is nice to know that there are alsonormal ways and means of improving times, distances andheights in sport. It's just a case of actually putting this techno-logy to use.

Author:Ulli Lansche, Dipl.-Inform. (FH),Technical Editor at MATRIX VISION, Oppenweiler, Germany

The work screen shows the individual walking picture

Various measurement- and picture-data support the analysis

CONTACT

MATRIX VISION GmbHTalstr. 16D-71570 OppenweilerPhone +49 7191 943 20www.matrix-vision.de

59


MEDDevices Robotics

Images:TQGroup

Robotics is ChangingMedicineEven in demanding fields such as surgery, the technolo-

gical enhancement of medical technology is providingpreviously unforeseen possibilities. Since the famous

surgeon Christiaan Barnard and his team performed the firstheart transplant in 1967 using scalpels and simple, manuallycontrolled instruments, medicine has undergone an enor-mous paradigm shift. Robots, robot-assisted systems andme-chatronic devices have been in use for some time already. Thesurgeon controls the instruments in the body of the patient ata separate console without having to work directly at the ope-rating table for the entire operation, often in positions thatlead to fatigue. In addition, today’s medical technology canhelp people with impaired motion regain their completehealth and even increase the mobility and independence ofthose with irreversible handicaps. Here, high-performancedrive technology forms the basis of efficient medical devices.

Design and Construction

New technologies are revolutionizing medicine. They presentpatients, doctors, clinics and companies with new possibili-ties. At the same time, however, the complexity ofmodernme-dical systems is increasing constantly, presenting the develo-pers of medical equipment with new challenges. To masterthis increasing complexity and allow medical technology ma-nufacturers to focus on their core competencies, systems are

increasingly being broken down into self-contained subsys-tems. It is here that drive systems often form the heart of auto-matedmedical technology. The interaction between all the in-dividual components is crucial for smooth integration into thesystem.

During theplanningphase, getting proper support fromadrivemanufacturer with comprehensive experience in the areas ofrobotics andmedical technology and with a wide product ran-ge can reduce not just the development time but also the ma-nufacturing costs of medical devices by several factors. It isalso advantageous if the drive manufacturer takes over thesystem responsibility for the drive system and complies withthe applicable medical technology specifications and the ap-propriate national regulations. The needs and requirementscould scarcely be more varied. For this reason, selecting theright drive manufacturer is a crucial factor for success.

Diverse Requirements Because of the DifferentFields of Application

If we take a closer look at various medical devices, it quicklybecomes obvious that drive systems tailored to the applicationrepresent the most important component of the overall sys-tem. Also, the demands placed on the drive systems are extre-

ServoKits and built-in motors like these from RoboDrive provide ma-ximum design freedom for structurally integrated drive technologywith their variable concept.

By developing new personal-ized therapy methods, it is pos-sible to make great strides inthe progress of modern medi-cine. Intensive research in ge-netics and further developmentof the tools and technologieshave allowed genetic informati-on to be sequenced and deco-ded at an extremely high rate.

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MEDDevices Robotics

Cicor GroupSwitzerland

Gebenloostrasse 159552 Bronschhofen

[email protected]

Cicor – Your technology partnerCicor is a global engineering and manufac-turing partner with innovative technology solutions for the electronics industry. With about 1,900 employees at ten production sites, Cicor manufactures highly complex printed circuit boards, hybrid circuits and 3D-MID solutions and offers complete electronic assembly and plastic injection molding. The Group supplies customized solutions from design to finished product for international customers.

Customized solutions

Cicor works together with its customers to develop innovative products and offers solutions that meet the needs of the market, reflect the latest trends and convince through their application. Cicor’s broad portfolio of innovative technologies, services and global production capacities offers the right solution for even the most demanding requirements, such as high-tech and high-reliability applications. Thanks to the focus on consistent quality and maximum trace-

ability, rapid prototyping, flexible choice of materials, miniaturization and realization of potential savings as well as the development and assembly services, Cicor is a partner that is able to meet the requirements of medical technology using new ideas and cutting-edge solutions. Cicor supports its customers starting in the planning stage, guaranteeing the ideal outsourcing solution, tailored to the customer‘s specific needs. Cicor is a partner over the entire product lifecycle, from product development through series production to after-sales service.

Company Profile

mely high and very diverse. Medical technology is a broadfield. It extends from surgical instruments, mobile devicesthat can be operated by the patient, diagnostic tools, to all ty-

pes of laboratory equipment. Over this range, different andspecial demands are made of the drive systems used in eachcase.However,maximum reliability, safe operation, awide dy-namic range and precision are becoming more and more im-portant. Due to the limited installation space,micro-drive sys-tems are playing an ever bigger role inmedical technology. Pri-marily the high-performance DC servomotors with unrivaledtorque density, high overload capability and a small installati-on length, which are a distinct advantage in a number of robo-tic applications, must be given amuch closer look.

Practical Examples

Minimally invasive operations have been on the rise since the90s. In these surgeries, which are less painful for the patient,instruments and endoscopes reach the area of the operationby way of a small point of entry. This is achieved without ha-ving to open the body of the patient using extended cuts as isthe case in conventional operations. With this new technique,greater injuries to the skin, the surrounding tissue and organscan be avoided, reducing the recovery time of the patient sub-stantially.

From the very beginning until today, the areas of application forminimally invasive surgery have developed at a rapid pace be-cause of the engineering advancements in medical technology.

The lightweight safety brakes with a hollow shaft are distinguished bya close braking torque tolerance, low heat generation and fail-safeoperation.

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MEDDevices Robotics

In the beginning, the instrumentswere still controlled by handand themovements during the operationwere reflected insidethe body of the patient by a pivotingmechanismat the point ofentry. To internalize the sequences of motions, the surgeonsrequire several years of training. Today, a robot controls the in-struments, easing the load on the surgeon and considerablyreducing the training time. The surgeon can perform the ope-ration without stress at a console equipped with 3-D vision.Even now, robot-based systems make demanding operationspossible, for example in urology, neurology and orthopedicsurgery, in a minimally invasive manner. Concepts for futuresurgical robot systems go even further. The cyclic movementsof the heart or of the respiratory tract will be captured using

camera systems and offset by the robot arms so that it will bepossible to perform bypass operations on a beating heart. Sys-tems that are to make such revolutionary operational procedu-res possible require high-performance, real-time data proces-sing and high-precision, dynamic but also sensitive drive sys-tems. The required precision and dynamic range are madepossible by the perfect interaction of optical and magnetic po-sition sensorswith sensitive torque sensors, servo inverterswitha very high sampling rate and control accuracy allowing rapiddisturbance suppression, and high-torque servomotors withbacklash-free gearboxes. Every robotic axis in medical techno-logy also has a safety brake to ensure the necessary safety evenif the power supply fails. Ideally, all these components must beintegrated in a compact way into a joint. Built-in servomotorsthat can be integrated structurally, known as ServoKits, and thecomponentsmatched to them geometrically provide the neces-sary compact design of the highly integrated axes. Surgical ro-bots are also usually chainedmulti-axis systems to allow thene-cessary degrees of freedom for the movements during the ope-ration. For this reason, light-weight drive systems with a hollowshaft, used to route the necessary cables and media to the in-strument, are especially suitable.

Following a successful operation, the goal in modern medi-cine is to start mobilization of the patient as early as possible.Even here, robotic systems that can be used as early as the in-

tensive care unit are providing new options for doctors, thera-pists and patients. The recently developed robot-based „VeryEarly Mobilization“ (VEM) therapy is an example of this de-velopment effort. Using specially equipped intensive carebeds, a badly injured patient can be raised vertically in bedwhile staying in the intensive care unit and gait training canstart. This early mobilization has positive effects not just onthe scope of the rehabilitation effort and its duration. Raisingthe patient to the vertical position and moving also train thecardiovascular function and the digestive tract. To developsuch robotic systems, high-torque drive axes and systems areused and they comply with medical technology requirementsand rules. Using finished standard solutions considerably re-duces the development time to market.

During post-clinical rehabilitation for treating impaired moti-on such as that following strokes or traumatic partial paraple-gia, electromechanical exoskeletons have been used for sometime. These are external support structures for the upper andlower extremities with powered joints. The exoskeletons areworn by the patient on the body and support themovements ofthe wearer or perform specific therapeutic movements. Theymake it possible for people with limited mobility to stand up,run or climb stairs again. Both the battery-operated mobilesystems and the systems used therapeutically contain thepowerful servomotors that run on a low voltage of between 24and 48 V that is not dangerous. The drive systems need to pro-vide, first and foremost, short axial installation lengths andlow weight to provide good wearing comfort for the exoskele-ton. In spite of this, an extreme torque response from a deadstop is required as are high speeds of motion. The propertiesrequired canbequantifiedusing thephysical properties of tor-que density and power density. These properties are achievedby means of an excellent copper fill factor.

When developingmedical devices, specifications, requirements,boundary conditions, general conditions and safety regulationsmust be obeyed. In addition, for many applications, keeping thetime required for development and approval as short as possibleis crucial for the commercial success of the products. Drive ma-nufacturers can, as the system supplier, provide the basis for sur-gical or therapeutic devices.

Author:Yvonne Fischer, Key Account Drive TechnologyTQ-Group

Absolute magnetic multi-turn encoders with hollow shaft deliver ab-solute position data with high resolution to efficiently control servo-motors with high precision.

CONTACT

TQ-Systems GmbHMühlstraße 2D-82229 SeefeldPhone +49 8153 930 80

www.tq-group.com

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MEDElectronic Assemblies/Boards

Images:FTC

APGmbH

Film Capacitors for High-Voltage ApplicationsFilmcapacitors aremanufactured from plastic films that

are coated on one side with a thin metal layer. The die-lectric strength depends on the thickness of the film

that is used – for higher voltages, thick films must be used asthe dielectric. The upper limit for a simple film capacitor is re-ached at a voltage of about 2.5 kV. If capacities for higher vol-tages are needed, several capacitors can be connected in se-ries. The voltage is then divided and each single capacitor isexposed only to a fraction of the total load. To save the user thework of assembling and connecting several single compo-nents, it is possible to combine several capacitor windings inone housing. As opposed to electrolytic capacitors, film capa-citors connected in series require no additional balancing re-sistors. Thismakes it possible to achieve high voltageswithoutthe disadvantage of additional losses.

Instead of connecting single windings, film capacitors offeranother, more elegant method of connecting the capacitors inseries: A special type of metal coating makes it possible tocreate a series connection directly on the film. Narrow metalstrips are vapour-deposited on the film in longitudinal directi-on,with free strips in betweenas insulation. This creates sever-al capacitances, which are connected in series. In this case,each single capacitance – i.e. each metal strip – must with-stand only part of the total voltage. If a film is wide enough,

FTCAP can implementmore than15 series connectionswithinone winding. It is therefore possible to manufacture singlewindings that are suitable for voltages of more than 40 kV.

Productionwith the Aid of Innovative Technologies

The production of high-voltage capacitors involves variouschallenges, which FTCAP overcomes with the aid of specialsystems and technologies. The Husum-based capacitor spe-cialist invested in a specially designed potting system for thispurpose. The goal is to achieve especially high-quality and ho-mogeneous insulationwith a newly developed vacuumpottingtechnology in order to minimise partial discharges. For thispurpose, a special pottingmaterial for high-voltage capacitorswas first subjected to thin-film degassing at 10 mbar. This isnecessary, because every air bubble in the capacitor cancausepartial discharges. Afterwards, the capacitors are filled withthe potting material under vacuum. FTCAP can also use thisinnovative potting system for potting segments. This techno-logyminimises air inclusions andenables optimal filling of thehousing. Another advantage of the custom system: It is veryflexible and can also be used for small volumes, which makesit ideal for the production of custom-tailored solutions of dif-ferent sizes.

Because requirements varywidely, FTCAPadapts the high-voltage ca-pacitors to the respective applications as needed

High-voltage capacitors areavailable for voltages of morethan 120 kV DC, which makesthem ideal for use in medicaldevices, high-voltage powersupply units, or even bodyscanners for building security.The product spectrum offeredby FTCAP includes numerousversions with different housingforms and connection techno-logy, including radial designswith wire and solder lugs.

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MEDElectronic Assemblies/Boards

tage cascades in X-ray machines or CT scanners to guaranteegood radiation characteristics. They can also perform the sa-me function in body scanners for building security. In additi-on, the solutions are also used to good effect in high-voltagepower supply units that are needed in research or for genera-ting magnetic fields. Accordingly, FTCAP’s customers alsoinclude numerous technical schools and universities.

The requirements vary widely due to the diversity of possibleapplications. That is why FTCAP adapts the capacitors to therespective applications as needed: For example, the edgesteepness (dU/dt) can be changed on an individual basis. Inaddition, capacitors can be manufactured in diverse versionsto facilitate integration in existing installation spaces. Thehousings are manufactured at the FTCAP factory in Husum;custom designs are no problem. And that applies not only tohigh-voltage capacitors: FTCAP is always the right partner forcapacitors for special applications in small andmedium-sizedquantities. The Husum-based company is one of the last en-terprises to manufacture all of its products in Germany – cus-tomers benefit from higher flexibility, optimal quality andsmooth coordinati-on processes.

Image:©Trish2

3–Fotolia

Because FTCAP always strives to convince its customers all alongthe line, each single high-voltage capacitor is subjected to exten-sive tests and measurements for quality assurance prior to deli-very. This likewise requires special equipment: Due to the broadproduct spectrum, the measuring equipment must also be veryflexible; for example, it must be able to accommodate the specialforms of high-voltage capacitors. To prevent stray currents duringthe measuring process, FTCAP conducts the measurements onlyin air-conditioned rooms with low relative humidity.

Individually Adaptable

Film capacitors for high-voltage applications:are also used inmedical technology: They generate high voltages in high-vol-

The product spectrum offered by FTCAP includes numerous versionsof high-voltage capacitors with different housing forms and connecti-on technology, including radial designs

CONTACT

FTCAP GmbHJens HeitmannCarl-Benz-Str. 1D-25813 HusumPhone +49 4841 89 57 11www.ftcap.de

High-voltage capacitors are available for voltages of more than 120 kV DC, whichmakes them ideal for use in medical devices

64

MEDElectronic Measurement Technology

Peltier elements enable reliable cooling and temperature settingof measuring devices andmaterials

Cool Samples and Ice-ColdMeasurement TechnologyAnalytic sensors and measurement systems are getting

more andmore efficient – but at the same time increas-ingly susceptible. Especially heat, no matter wether

derived frompower loss or from the surroundings,maynot onlydisturb the sensitive systems, but can also alter samples anddistort measuring results.

Sensor expert Eureca Messtechnik GmbH develops customcooling systems that are perfectly suitable for assembly intosmall and sensitive areas such as measuring devices. Peltierelements used for this are scarcely space-consuming and donot containmoving parts, whichmakes themdurable and low-maintenance. Compared to compressors, there is no danger ofcoolant leaks or defects due towear. To ensure optimal coolingpower, the elements are sized and tailored according to thespecific application. A simulation software, developed in-house, provides data for optimized systems.

A variety of problems in analytic processes arise from the tem-perature dependence of the semiconductors in themeasuringdevices themselves and from the temperature sensitivity of

the samples to be measured which can undergo unwantedchanges by heating up during measurement.

In case highly precisemeasurement results are required, a re-liable cooling is indispensible. However, this is not easily ac-complished by conventional means. Although low-vibrationhigh-power cooling compressors are available, their sheer sizeoften makes them unsuitable for the cooling of measurementsystems. Peltier elements are an ideal substitute, since coo-ling is based on a thermoelectric effect, that needs neitherpressure nor cooling agents. The component works as a heatpump which enables a controlled heat transfer.

Adjusted Cooling Elements Save Space andCosts

Peltier elements basically consist of differently dotedbismuthtelluride blocks that are soldered between ceramic platesma-king these parts compact and flat. The service life of these ele-ments can be thirty years and even longer, while maintainingnearly all of their performance. »



Images:EUREC

AMES

STEC

HNIKGMBH

The elements can be produced in various sizes and coolingperformances so that there is a part for nearly every applicati-on available or can be developed easily. „Depending on thespecific requirements, such developments pay off at rathersmall numbers, such as 1,000 elements“, says Ina Senge-busch, consultant for thermal management at Eureca.

A very common adjustment of the elements is the sealing ofthe gap between the ceramic plates with silicone, polyuretha-ne or epoxide to protect them against moisture and to guaran-tee performance stability. „This is important for applicationsat normal air humidity and room temperature, otherwise thecondensing water could spoil performance as well as servicelife“, Sengebusch says. In addition, custom as well as stan-dard elements can be equipped with wires and connectors toensure an easy assembly into measuring devices. Furthermo-re, Eureca offers laser engraving of the designation type or per-formance values, so every part, even uncommon configurati-ons, can easily and permanently be identified.

Adjustments up to theLevel of Custom Designs,Based on Simulations

In order to determine the dimensi-ons of a suitable peltier elementwith regards to cooling temperatu-re, cooling power and the respectiveconditions of the surroundings, Eu-reca has developed a simulationsoftware that describes heat flowsin various configurations and condi-tions. This leads to a physically ba-sed selection of suitable compo-nents and reduces unnecessary tri-al-and-error loops that are oftenused for approaching a suitable so-lution. According to the simulatedvalues, specific characteristics of

the peltier elements are determined.

Based on this, a suitable element can either be selected fromthe broad variety of standard types or a customdevelopment canbe decided on, which can easily be started using the simulatedvalues. For theproduction,Eureca cooperateswith several inter-national manufacturers that provide all cost and quality levelsfrom low-cost to high-end. The range of standard sizes is from4.3 x 4.3mm,which can for example be used for single sensors,up to high-performance elements with sizes up to 62 x 62mm.

Using single elements, coolingpowers up to450Watt andmo-re can be achieved. For higher cooling power, parallel use ofmultiple elements is common practice. Moreover, multistageelements are available for low-temperature applications,which provide temperature differences between the hot andthe cold side of up to above 130 Kelvin.

Optionally Eureca also manufactures complete cooling modules. Inthis way, a smooth cooperation of its components and a reliable heattransfer from the sensor or sample to the heat sink can be accomplis-hed.

The function is based on the peltier effect that occurs between reciprocally connected semiconduc-tors with different thermal forces. If this setup is connected to the power supply, electrons migrateinto the energetically higher conduction band, absorbing energy, which cools down the surroun-dings. On the other side, this procedure occurs inversely and heat is emitted.

Maintenance-free cooling in small spaces: peltier elements enabledefined temperature control of samples andmeasuring devices andthus enhance analysis quality.

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OCEAN OPTICS The Netherlands

Geograaf 24 6921 EW Duiven

Phone +31 26 319-0500 [email protected] www.OceanOptics.com

Ocean Optics combines system design, integration capabilities and applications knowledge to help people solve problems using light measurement. We offer a suite of modular spectroscopy products, multispectral sensing solutions and software development for diverse applications in industrial settings, research and science, applied biotechnology and life sciences, and medical diagnostics.

Ocean Optics products can be used for single-setup research applications and for embedding into OEM devices. Our products can be sourced at the component, subas-sembly or system level, depending on the user’s needs and the stage of product de-velopment. Also, Ocean Optics products are scalable, enabling us to provide customized solutions with mass production efficiencies.

Ocean Optics offers an array of optical engi-neering and application support, from optical design and software engineering to rapid prototyping and feasibility testing. Our en-gineering team works closely with product developers to ensure a seamless transition from development to launch, and has signifi-cant experience in helping to implement systems for the medical device industry.

ISO 9001 : 2008 certification, compliance with RoHS requirements and support for indust-ry-specific requirements such as FDA, UL and CE approval help ensure quality and reliability.

Among our latest biomedical innovations is a multispectral sensor for point of care molecu-lar diagnostics. This highly integrated mul-tispectral sensor reduces the complexity, footprint, and cost of OEM bioengineering instrumentation significantly. For example, in contrast to the full spectrum acquired by a spectrometer, a multispectral sensor collects data only at the wavelength bands of most interest to the application. By integrating filtering and detection into monolithic elements in an array of up to 8 channels, the breakth-rough PixelSensor™ multispectral sensor offers even greater multispectral detection efficiency in an ultra-compact package.

Company Profile

Complete Assemblies Achieve High Reliabilty

Besides the selection or thedesign of peltier elements, Eurecaalso determines all other components that are necessary forthe smooth operation of the peltier elements, such as heatsinks, fans, if applicable, water coolings as well as heat con-ductive products e.g. glues, pads or pastes. In this way, effici-

ent heat conduction between the sample or the sensor and theheat sink or water cooling is achieved. To accomplish the re-quired temperature, Eureca also selects appropriate powersupplies, temperature sensors and controllers and also as-sembles cooling modules from prototypes or single parts, upto serial production.

What the setup looks like for a specific application is decideddue to the results of the simulations and in in-depth discussi-ons with the customer. This ensures technical feasibility aswell as quality demands and return on investment. Eureca iswidely experienced with an abundance of projects in variousindustrial fields, so solutions can be provided for nearly everyapplication.

The supplier also labels peltier elementswith durable laser engraving,e.g. with barcodes or power values. Wire ends can be equipped withconnectors and subassemblies can easily be mounted.

CONTACT

EURECAMESSTECHNIK GMBHEupener Straße 150D-50933 KölnPhone +49 221 952 62 90

www.eureca.de

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MEDengineering INTERNATIONAL/2018 www.med-eng.de

MEDElectronic Power Electronics

Power Supply Management of GaNMMIC Power Amplifiers forPulsed Radar

Management of GaNMMIC Power AmplifiersSystems that incorporate highly integrated and highly

sophisticated, high power radio frequency (RF) GaNpower amplifiers (PAs), such as pulsed radar applicati-

ons, are a constant challenge for today’s digital control andmanagement systems to keep up with these ever-increasinglevels of sophistication. To compete in this market, today’scontrol systems must be extremely flexible, reusable, and ea-sily adaptable to various RF amplifier architectures that canbe tailored to meet the needs of the customer.

These complexmanagement systems require innovative com-pensation algorithms, built-in-test (BIT) features, local andremote communication interfaces, monitoring of critical sys-tem performance parameters and environmental conditions,and system fault protection. The increased complexity of the-se systems is driven by the demand for higher power fromsem-iconductor-based RF systems.

These high power systems create a tremendous amount of heat,which has an impact on amplifier performance andmean timesbetween failure (MTBF). The RF amplifier MMICs required forthese systems are expensive, high power devices. As a result,customerswant tomonitor the performance and temperature ofthe GaN PA-based systems in real-time. This allows for detecti-on of impending problems in advance of damage so they cantake the necessary actions to prevent it. With proper controlelectronics design, implementations can be extremely flexibleand can be utilized with any RF amplifier architecture. The di-gital electronics can be tailored to the needs of the customer.The digital design can include built-in protection logic to disab-le theGaNRFamplifiers as damage thresholds are approached.

These key features play a critical role in theneed to optimize theRF performance over wide bandwidths and temperatures. Theyfacilitate high levels of testability, maintainability, ease of sys-tem integration, and calibration—thus providing a technologi-cal differentiation. Today’s semiconductor RF amplifiers conti-nue to increase in complexity and output power. In order to op-timize performance, manage power sequencing, provide fault

detection, and provide amplifier systemmonitoring andprotec-tion, electronics can be implemented using reprogrammablefield programmable gate arrays (FPGAs) and/or microcontrol-lers. The reprogrammable solution provides the flexibility re-quired for today’s development of advanced RF amplifier sub-systems. The reprogrammability minimizes the risks of circuitboard redesign and schedule delays due to design errors.

These amplifier systems have similar, but different, require-ments that are application dependent. The digital controlelectronics architecture is tailored to fit the application requi-rements and typically consists of:

+ Digital controller

+ Nonvolatile memory

+ Analog-to-digital converter (ADC)

+ Digital-to-analog converter (DAC)

+ Digital input/output (I/O)

+ DC power conditioning

+ Communication interfaces

+ Various analog sensors

Reuse of hardware and software is key to being able to developdesign variants quickly and efficiently. These features reducethe time for factory test and calibration, and provide an impor-tant diagnostic tool that aids in the debug of systemproblems.Themajority of control systems for ADI RF amplifiers have uti-lized FPGAs. These devices are highly versatile and can inclu-de internal soft core or embedded processors. FPGAs can im-plementmultiple parallel functions that can all operate simul-taneously and independently.

Therefore the FPGA has the ability to rapidly react to commandsand critical circuit conditions to protect the RF electronics. Lo-gic functions and algorithms are typically implemented in ahardware description language (HDL) such as Verilog or VHDL.Execution of logic functions are controlled by state-machine lo-gic within the FPGA. A state-machine controls the sequence ofoperations performedbased on the input and output conditions.

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MEDElektronic Power Electronics

www.med-eng.de MEDengineering INTERNATIONAL/2018

Grafic:A

nalogDevices

GmbH

Edmund Optics GmbH

Germany Isaac-Fulda-Allee 5

55124 Mainz Phone +49 (0)6131 5700-0 Fax +49 (0)6131 21723-06

[email protected] www.edmundoptics.de

Edmund Optics – From Design to Prototype to Volume Production• US based company with global locations

for manufacturing, sales- and distribution• More than 75 years successful company

history• World’s largest inventory of optical compo-

nents with more than 30.100 products in stock

• Manufacturing capabilities: prototyping, customized production, modifications with quick turnaround, serial production

• 20.000 stock product available for quick modifications

• Trustful partner for various industries, institutions, institutes, and universities

• EO offers numerous optical components enabling life science devices and treatment methods

We Design I We Manufacture I We DeliverEdmund Optics® (EO) is a leading global manufacturer and distributor of precision optics, optical assemblies and imaging compo-nents with headquarters in the USA and

manufacturing facilities in the US, Asia and Europe and sales representatives around the globe. With a portfolio of more than 30.100 products, EO has the world’s largest inventory of optical components for immediate delivery and offers products, standard or customized, in small quantities but also in volume for various industries. With a global team of experts in optical design and manufacturing, EO is ready to support your next project – from prototyping all the way to serial production. You can reach us via phone +49 (0)6131 5700-0 or by email [email protected]. Please also ask for our latest catalog, we are happy to send it to you, just contact us!

Company Profile

Optimization of amplifier performance: In order to optimizeamplifier performance, the gate voltage must be set to achievethe amplifier specified power supply current in the data sheet.The gate voltage is adjusted with a DAC while monitoring thepower amplifier’s power supply current using an ADC. These fea-tures provide the ability to rapidly calibrate the RF amplifier gatevoltage without the need to probe or modify the RF electronics.

Enhanced power sequencing, power management, power sup-ply monitoring: The FPGA design can be implemented to se-quence voltage regulators and RF amplifiers to minimize pow-er-up current, andmonitor and detect amplifier and power sup-ply faults. The FPGA can take protective action by shuttingdown system components based on detection of a fault conditi-

on, or report status via the control interface to a computer. TheFPGA canmanage overall system power dissipation by shuttingdown circuitry that is not actively being used (standby mode).

Temperature monitoring, thermal management: Temperature isa critical factor for RF performance in high power amplifier sys-tems. Having the provision to monitor temperature allows theFPGA to implement algorithms that compensate amplifiers overtemperature. Also, with temperature monitoring, the FPGA canbe used to control cooling systems such as fan speed in order tominimize performance degradation. The logic can detect poten-tially damaging thermal conditions and take appropriate actions.

Digital and analog I/O: The FPGA can control RF switches,phase shifters, digital attenuators, and voltage variable atte-nuators (analog attenuators). Almost any analog sensor signalcan be interfaced to the FPGA using ADCs. As long as the in-formation of interest can be put into a digital format and con-nected to the FPGA, the information or signal of interest canbemonitored and/or applied to an algorithm for processing.

Control, computer interfaces, graphic user interface (GUI):These are perhaps the most important aspects of the manage-ment system, as they provide easy access to all of the control,sensor, and diagnostic data available from the amplifier system.A GUI can be developed to format all of the control and status

Figure 1. Typical GaN PA control system.

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MEDElectronic Power Electronics

Grafics:An

alog

Devices

GmbH

information into an easy to use human interface. Softwarescripts may be developed to facilitate extremely high produc-tion test coverage, calibration, and failure analysis throughoutsystem integration and final tests. Test data can be written tocomputer files or read fromcomputer files, and calibration da-ta can be stored into NVRAM for use during run-time as varia-bles to compensation algorithms. Beyond factory use, thispowerful interface tool can be utilized in the field to monitorsystem health, determine system root cause failures, and pro-vide easy field upgrades of control software. Variants of this in-terface can lend themselves easily to Internet of Things (IoT)applications, helping to bring intelligence to the edge.

GaN RF power amplifiers are used in both continuous wave(CW)mode andpulsedmode applications. Pulsed operation ismore challenging from a control standpoint, so it is the focusof this discussion. Pulsed RFmay be utilized for communica-tions, medical, and radar applications, to name a few.

Pulsed operation has the benefit of reduced thermal dissipationfacilitating less demanding cooling schemes andminimizes thesystems external dc power requirements. However, increasedpulsed repetition frequencies (PRFs) combined with lower dutycycles and faster settling time requirements continue to pushthe latest technology. Our approach to these demanding requi-rements has been to utilize digital control systems to pulse theRFMMICs. Field programmable gate arrays are typically used toenable/disable the RF MMICs using either gate or drain pulsingtechniques depending on the system requirements. The FPGA’scontrol interface to the RF MMICs typically consists of circuitryto switch power to the MMIC’s drain, or some form of analog ordigital-to-analog circuit that interfaces to the gate. Dependingon switching speed and settling time requirements, capacitorbanks may be required to store energy locally for most efficientdc biasing when pulsing the MMICs. The FPGA can receive asingle pulsed signal anddistribute it to one, ormany,RFMMICdevices, while maintaining a close timing relationship.

The benefit of gate pulsing in high power pulsed applications isthat high dc switching is not required. However, gate pulsingmay

be complicated by the requirement that the gate voltage must beprecise and well controlled to optimize the RF performance.MMIC characterization data is typically performed at a single sta-tic gate bias condition—where the MMIC performance is best.The MMICs are typically not characterized for pulsed operation.Some MMICs have exhibited instabilities when the gate voltagesswitch the MMIC between the pinch-off state and the on state.

Drain pulsing may be more forgiving, and may require lessMMIC characterization data. Each pulsed application’s requi-rements must be carefully reviewed to determine the optimalpulsing methodology and circuitry. Any MMIC pulsing appli-cation, either gate or drain pulsing, should be evaluated withthe actual intendedMMIC to be used in the design.

Analog Devices continues to develop and field complex RF poweramplifier systems to our customers. To compete in this market,today’s control systemsmust be extremely flexible, reusable, andeasily adaptable to various RF amplifier architectures that can betailored to meet the needs of the customer. They can include bu-ilt-in protection logic to disable the RF amplifiers as damagethresholds are approached and play a critical role in the need tooptimize RF performance over wide bandwidths and operatingtemperatures. They facilitate high levels of testability,maintaina-bility, ease of system integration, and calibration—thusprovidinga technological differentiation from competitors that impactfullyinnovates with today’s high power amplifier management sys-tems. The MMIC power management systems implemented inthese systems have enabled ADI tomove up the stack by allowingfor ADI to partner with our customers to provide them systemsthat integrate seamlessly with their own systems. The need forthese types of semiconductor RF amplifier systems continues togrow. As the complexity of these systems continues to increase,the complexity of the digital control electronics required to pro-tect and control thesesystems will also con-tinue to grow as wecontinue to innovateon today’s high powerGaN-based amplifiermanagement systems.

70

Authors:David Bennett and Richard DiAngeloAnalog Devices, Inc.

Figure 3. Typical drain switching scheme.

Figure 2. Typical gate control scheme.

CONTACT

Analog Devices GmbHOtl-Aicher-Str. 60-64D-80807MünchenPhone +49 89 76 90 30www.analog.com


MEDSoftware Engineering Tools

The whole development process should be considered – it mayturn out that using SOUP will be more expensive than in-housedevelopment

Safe Software Engineeringby Suitable ComponentsSoftware systems sometimes require the implementation

of features which do not fall into the manufacturer’s corecompetence. The following options can be considered:

+ Build own know how and develop the functionality fromscratch

+ Use standard products. In a regulated environment, thisraises additional challenges: Software, which is incorpo-rated in a medical product, shall meet specific criteria.The IEC 62304 defines these criteria and introduces theterm “Software of Unknown Provenance (SOUP)“ for soft-ware, which has not been developed in accordance withthe regulatory requirements. Furthermore, it imposes ru-les for the use of SOUP.

+ Use a library which has been developed in accordancewith IEC 62304. Such a library is not SOUP according tothe term’s definition and can be integrated like an in-house development (with respect to the safety-class). Indevelopment of libraries for the integration of medicalequipment into clinical IT infrastructures, softgate conse-quently pursues this approach. We are convinced that theclassification “compliant with regulatory requirements“adds significant value to our products.

Regardless of the chosen approach, thewhole development pro-cess should be considered – itmay turn out that using SOUPwillbe more expensive than in-house development from scratch.

Requirements

The IEC62304demands the specification of functional-, perfor-mance- and environmental (hard- and software-) requirementsfor SOUP components, according to their intended use. A lot de-pends on the questionwhether the developer teamhas expert-le-vel knowledge in the library’s domain. It often requires experts toassess the practical relevance of options and characteristics,e.g. for a library implementing complex communication proto-cols. For a IEC62304-conformant library, a requirement specifi-cation must exist. Requirements referring to the product can be

partially obtained from that document. The safety-classes of pro-duct and library must be verified for compatibility.

An important aspect is the error handling provided by the lib-rary. Will critical states be detected and reported? With a con-formant library, it should be safe to assume that this has beenadequately treated and documented in the scope of the riskmanagement process. SOUPsoftware rarely specifies require-ments of the target system in enough detail. For conformantlibraries, they must be defined and documented.

Architecture

The architecture has to reflect the segregation necessary for riskcontrol. Potential costs for development and possibly produc-tion may be hidden here. As, by definition, a SOUPmust not beassumed to have any quality properties, the execution on dedi-cated system resources is a very common approach to this – atthe cost ofmore expensive hardware and the development effort

Worst Case – SOUP Encapsulation

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for a wrapper-process with inter-process-communication (IPC).A conformant library which is classified to be at least in the sa-me safety-class as the product does not need such segregation.

Test

Tests have to verify that the application meets the functionalrequirements by means of the library. Strictly interpreted,every potential root cause for an error message has to be tes-ted. It often requires expert-level knowledge to set up the testscenarios needed for this coverage. Therefore, it is advisableto consider the question “how can this be verified?“ during re-quirement specification. Vendors of conformant libraries areobliged to document test results for all requirements. Thesetest records provide valid evidence for the product documen-tation. This means, test coverage aligned to functionality anderror handling of the product is sufficient.

Risk Management

For library functions contained in the risk graph, control mea-sures must be implemented in the event of the library retur-ning erroneous results (theprobability has to be assumed tobe100%). With SOUP this is usually possible outside the libraryonly. Thus, code for assessing the library’s results andpossiblyredundant functionality has to be developed. A conformantlibrary comes with its own risk management documentation.This means:

+ Hazards have been analyzed by domain experts. Possibly,risks were identified which would have been disregardedotherwise.

+ Inherent risk control measures are implemented withinthe library

So the risk analysis provided by the library manufacturer pro-vides connecting factors for the product’s risk analysis. Ideal-ly, it boils down to assess the hazards in the product’s contextand reference the control measures which are already imple-

mented. Obviously, the library’s risk analysis cannotmake anystatements about probabilities and impacts of hazards; theseare only valid in the context of the product.

Observation

Market observation starts with product shipping and has toinclude the SOUP. IEC 62304 requires periodically monito-ring the SOUP’s bug lists, assessing the impact to the productand taking appropriate action. This obligation refers to theproductmanufacturer. If a safety-relevant issue is discovered,one has to rely on the cooperation by the SOUP vendor.A conformant library must have its own market observationand reporting process. Themanufacturer is obliged to react tofeedback from the field appropriately. This implies forwardingrelevant information to all affected product users and provi-ding an update timely.

Conclusion

The usage of SOUP should be planned with care to avoid theemergence of unexpected costs while the development is alrea-dy in progress. Using a conformant librarymitigates integrationefforts and project risks significantly. It is worth to compare itsprice to the costs ofan in-house develop-ment and the expec-ted effort for integra-ting a SOUP.

Author:Dipl. Inf. (FH) Markus Sabin,softgate GmbH

Best Case: conformant library of the same safety-class as the product

Transfer of Risk Documentation

CONTACT

softgate GmbHAllee am Röthelheimpark 43D-91052 Erlangen

www.soft-gate.de/en

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GmbH


MEDSoftware Data Security

Medical technology enterprises are exposed to massive global compe-tition. At the same time,medical devices are increasingly interconnec-ted. More andmore of their functions are realized by software alone.

Protecting the Softwarein Medical DevicesMedical devices are increasingly interconnected and

linked up with the hospital networks around them.Protecting this software is essential in many aspects:

+ Integrity: Technicalmeansneed tobe inplace to shield thesoftware againstmanipulation and ensure that the devicesfunction exactly as the FDA and the Medical Products Actdemand.

+ Communication: Every connected device needs a uniqueidentity to ensure safe communication.

+ Settings and configurations: The right settings can be amatter of life or death. They need to be protected againsttampering and cyber-attacks.

+ Patient data: Whenever devices share patient data, e.g.with the patient file, that data needs to be confidential andtamper-proof.

+ Intellectual property: Protecting the software against reverseengineering and piracy helps save the essential know-how ofdevice makers in their tough competitive environment.

The flexible configuration of device options is a helpful andnecessary way to keep medical device makers competitive.They can offer cheaper entry-level models with only a basicfeature set and then sell add-on functions and other USPsthrough many different channels, as a one-off purchase, asannual subscriptions, or in a pay-per-use system. The ap-proach resembles the smartphones that everybody has cometo know and love: The user can tailor their devices to theirneeds and only pay for what they actually need. At the sametime, they can keep their options open for later upgrades.

The medical field has at least as high standards as Industrie4.0 or the Internet of Things. Security is a must-have; flexibi-lity and opportunities to monetize software-based functionsare nice-to-haves with considerable commercial promise.

Protection and Licensing

Wibu-Systems has developed CodeMeter to support devicemakers with a technical means to secure the software compo-nents in their products. CodeMeter encrypts and signs thesoftware associated with the devices to complicate and pre-vent reverse engineering andpiracy and tomakemanipulationimpossible. Manufacturers can employ the system to selecti-vely activate individual features or functions. This can be in-tegrated automatically in their business processes to createentirely new commercial opportunities. The technology canalso be used to track (and limit) usage, e.g. for limited produc-tion runs.

To store licenses and entitlement rights safely, the systemuses either exclusively software-based CmActLicense or theprotection hardware CmDongle, which is available inmany in-dustry-ready form factors for USB, SD,microSD, CFast, CF in-

Medical applications by custo med

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MEDSoftware Data Security

terfaces or as ASICs in a tiny VQFN case with USB and SPI in-terfaces. All versions contain a smart card chip with moderncryptographic capabilities, not unlike the technology used inthe healthcare card or the modern smart passport.

High security is achieved with cutting-edge, robust encryptiontechnology like symmetric AES (AdvancedEncryption Standard)or asymmetric RSA or ECC (Elliptic Curve Cryptography) encryp-tion. The protected software is signed and encrypted, and the re-quired code is only decrypted if the right license is available.

In the Field

Four case studies serve to reveal the special requirements ofmedical device makers and how they managed to implementnew protection and licensing strategies:

Agfa HealthCare is a world-leading specialists for radiogra-phic diagnostics and IT solutions for hospitals and other clini-cal facilities. The companyhas comeupwith a newway of pay-ing for its computed radiography (CR) equipment: the “EasyPayment“ system. Using CodeMeter, the system relies ontime-based usage models. Hospitals or medical professionalswho are not able to cover the steep upfront costs of buying themachines or who are not willing to tie up so much capital intheir hardware, can now get cheaper access to the CR equip-ment and then pay only for their actual use. An online portal,built around CodeMeter License Central, handles everythingfully automatically. It is a win-win situation for both parties:Agfa can get more of its devices into frontline medical care,andpatients in emergingmarkets like India gain access to cut-ting-edge medical diagnostics that their hospitals mightotherwise not have been able or willing to fund without thepayment system.

Custo med is another spe-cialist for diagnostic sys-tems and the innovator be-hind the medical platformcusto diagnostic, whichbrings together a range ofsoftware packages andhardware devices to trackECG data, blood pressure,and lung function. Code-Meter protects this mostsensitive of patient infor-

mation and ensures its confidentiality, while maintaining fulltraceability and guarding against manipulation, as required bymedical guidelines. CmDongle is built into the system’s com-puter hardware to prevent its accidental loss. For special targetgroups, custo med also uses software-based protections. Theservice technicians benefit from additional safeguards:CmDongles come with temporary licenses that they need whenmaintaining sensitive parts of the software.

The emergency ventilation systems EVE by the leader in thefield, Fritz Stephan, save lives every day, and CodeMeter savesthe intellectual property invested in the software from the threatof product piracy, reverse engineering, and manipulation. Theusers benefit from the opportunity to buy a tailor-made devicefor their needs. The CmCard/SD is integrated in all EVE devicesand includes cryptographic keys, digital signatures, certifica-tes, and licenses. These licenses control the feature set paid forby the user, e.g. for neonatal, child, or adult care. More featurescanbe addedat a later date – a rewarding after-sales opportunityfor Fritz Stephan that is fully integrated with its business proc-esses and realized with a simple app store system.

On top of securing its know-how, guarding against manipulation,and preventing product piracy, Dentsply Sirona, a global dentaltechnology enterprise, uses CodeMeter to protect its CEREC aswell as the material needed to produce dental implants. A unitcounter on the CmDongle allows the operator to mill as many ofthe so-called blocs as he or she needs. CodeMeter alsomakes su-re that the encrypted software cannot be tampered with. Thesales team creates the licenses that are stored on the CmDongleand determines users' entitlements for the devices.

Author:Oliver Winzenried, CEO of WIBU-SYSTEMS AGand Head of the Medical Technology Working Group of the VDMA

The emergency ventilation unit EVE at work in an ambulance

Computed radiography by AgfaHealthCare

CONTACT

WIBU-SYSTEMS AGRueppurrer Str. 52-54D-76137 KarlsruhePhone +49 721 93 17 20www.wibu.com

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Cables with germ-repellent surfaces – Coroflex® HospitalCoroplast is a successful, independent, family business with operations worldwide. In the course of our 90-year history, we have developed from a local manufacturer to a technology leader in the fields of Technical Adhesives Tapes, Wires & Cables and Cable Assemblies. Employing around 6,200 people, we not only manufacture at our headquarters in Wuppertal, but also in Poland, China, Tunisia, the USA, Mexico and Moldova. These activities put us close to our customers in the medical technology and the automotive sector as well as many other industries.

Coroflex® Hospital

Multi-drug-resistant organisms in hospitals regularly make the headlines. Bacteria such as MRSA can cause dangerous infections in chronically ill patients or those with weakened immune systems. Here, the focus is also on medical devices and their cables, which can often be only insufficiently cleaned and disinfected. To combat this problem, we have developed the Coroflex® Hospital line with the following advantages:

■ Antimicrobial surfaces ■ Easy to clean (VDMA 12/2007) ■ Resistant to cleaning agents and disinfec-tants (ECOLAB)

■ Suitable for high-pressure water jets (IPX9K)

■ Talcum-free ■ Antistatic sheath surfaces

Customised solutions

Our Coroflex® Hospital cables are designed in a modular system and deployed in applica-

tions such as diagnostic equipment, in high-frequency surgery, or as either reusable or disposable cable harnesses for surgical use. Moreover, our broad range of products offers a great many more tailor-made solutions:

■ High-temperature cables (up to +275 °C) made with fluoropolymer materials such as ETFE, FEP, PFA and silicones

■ Hybrid cables such as FEP silicone sheathed cables for applications that in-clude defibrillators or sensor technology

■ Highly stressable cables, e.g. H05BQ-F for applications exposed to high mechanical stress

■ Cables for lighting systems, made of materi-als such as PVC (105 °C), TPE (120 °C), FEP and silicone (180 °C)

■ Shealded cables, e.g. with foil screen, spiral screen or braided screen

Certified quality

Particularly in the field of medical technology, the highest quality standards are required. For that reason, our Coroflex® products are continu-ally checked and certified.

■ Test standards: ISO 14644-8 (outgassing), ISO 846 (biological resistance), ISO 14644 (low particle emissions), ISO 22196 (antimi-crobial)

■ Certifications: UL, CSA, CURUS, VDE/HAR, Fraunhofer IPA, ECOLAB

Coroflex® product family

The application-oriented Coroflex® product family serves the needs of a wide array of industries. Apart from cables for medical applications, we also offer the Coroflex® Sensor, Cleanroom, and Food & Beverage ranges.

We will be happy to provide you with additional information.

Company Profile

Coroplast Fritz Müller

GmbH & Co. KGGermany

Wittener Straße 271 42279 Wuppertal

Klaus Peter Döpper T +49 (0)202 2681 228 F +49 (0)202 2681 360 [email protected]

www.coroplast.de/en/coroflex

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MEDSoftware Simulation

Model-based software development is being increasingly used inthe field of medical technology to keep both complexity and costsunder control.

Model-Based Developmentof Medical SoftwareThe development effort is increasing substantially due

to the expectations placed onmedical devices in termsof their safe and intuitive use. Alongside regulatory re-

quirements at a national and international level, systems arebecomingmore andmore complex due to their growing rangeof functions, made possible thanks to the greater computingcapacity available. Connectivity and modern user interfacesare examples of this. Rising cost pressure and shorter de-velopment cycles call for methods that enable efficient soft-ware development.

The answer to these challenges is model-based design, whichcan be used throughout the entire software development pro-cess. The high degree of automation with both code generati-on and testing make it easier to track the implementation ofuser requirements in all stages of the development process.Therefore the traceability, as required by IEC 62304 and ISO14971 for example, is made simpler. The model-based de-

velopment approach promotes themodularized design of soft-ware, thus resulting in more reusable modules and bettermaintainability of the end product. Practical applicationsshow that redesigning the structure or adapting the softwarearchitecture ismore easily done in themodel than in the code.According to empirical data from previous projects, the resul-ting ease of inducting new associates and the more efficientcare of existing products can reduce development and main-tenance costs by 20-30 percent. Furthermore, model simula-tion and testing provide information on the quality of the de-sign and implementation at a very early development stage.Identifying and eliminating faults as early as possible duringthedevelopment process is also a significant factorwhen it co-mes to reducing development costs.

Model-based development has been used extensively in othersectors (e.g., the automotive and aerospace industries) forquite some time now.

In model-based software development, the program code is generated from a (graphical) model.

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Model-Based Development Process

Model-based software development provides for the formalspecification of the software being developed in a graphicallanguage. This applies both to the architecture and to the spe-cific implementation of requirements.

The graphical specification results in an additional level ofabstraction over and above the familiar conventional softwaredevelopment levels of machine code (assemblers) and pro-gram code in a high-level language (e.g., C). The graphicalrepresentation abstracts, for example, from the hardwareused or from the specific execution of arithmetical operations.This promotes an intuitive understanding of the softwarebeing created and allows for more effective reviews. Thismeans associates can bemore easily trained inmajor projectsand the susceptibility to errors when extending ormaintainingsystems is reduced. As with machine code compilation, thegraphical software specification in program code can be per-formed automatically using a code generator .

Development tools such asMATLAB, for example,which focuson simulation, enable the creation of a physical environmentmodel to simulate the interaction between the software (forinstance a control algorithm) and the environment. As a result,softwaremodules that are not directly dependent on the hard-ware used can be developed and tested before the hardwarethat is actually utilized in the end is available. In addition, re-producible, system-level tests, which require long lead timeslasting several hours or even days, can be carried out duringthe simulation using different stimuli. Examples of this inclu-de therapeutic techniques from the field of sleep medicine(one night of therapy lasts between 6 and 12 hours) or tempe-rature control systems for medical devices.

Module Test

In the case of standard-compliant software development, mo-dule-level tests are essential. They allow the test coverage of asoftware to be increased, as conditions that are either difficultto test during system tests or cannot be tested at all can bespecifically created. In model-based development, this canbe done using both the model and the code generated from it.The former is known as a „model-in-the-loop“ (MiL) test, andthe latter „software-in-the-loop“ (SiL). A comparison of the re-sults provided by the MiL and SiL tests can also be used tocheck whether the behavior of the automatically generatedcode corresponds to the behavior specified in the model. If itdoes, the code generator has produced a valid result. Finally,processor-in-the-loop (PiL) tests enable the behavior on thetarget hardware to be verified.

Automated Test Processes

An isolated module test requires an environment model thatcan provide the necessary input values and evaluate the out-

put values with regard to specified acceptance criteria. Auto-mation tools are used for creation and maintenance purposesas well as for effective generation of the stimuli. In this way,repetitive test activities can be efficiently reproduced.Moreo-ver, this automated process enables agreed conventions rela-ting to the configuration and documentation of tests to be im-plemented at little cost and effort.

Automating the test creation, implementation, and evaluationprocesses reduces the time which has to be estimated for tes-ting the systems. Since extensive tests on the model can beperformed at an early stage of the development process, anyrisks associated with validation or market launch at the end ofa project are reduced.

Conclusion

Model-based software development can create medical softwareboth efficiently and in compliance with relevant standards. Com-pared to conventional software development, the possibility ofearly-stage testing, in particular, is a major advantage in terms ofquality assurance. Powerful tools assist in the various stages ofthe development process and guarantee both traceability andconsistency throughout.

Author:Dr. Jochen Furthmüller, Senior Engineer,Medical Software Engineering

Author:Dr. Michael Schwarz, Senior Engineer, Medical Control Sys-tems andModel-Based Design

CONTACT

ITK Engineering GmbHIm Speyerer Tal 6D-76761 RülzheimPhone +49 7272 770 30www.itk-engineering.com

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The containment of cardiovascular diseases, which are mostlyfound in industrialized countries, could help to promote individualdiagnosis and treatment.

Realistic Simulation of aHuman HeartCardiovascular diseases are the causes of almost a quarter

of all deaths worldwide. According to the World HealthOrganization*, 15 million people died of cardiovascular

diseases in 2015. This corresponds to about a quarter of alldeaths worldwide. These dramatic figures are confirmed by theFederal Statistical Office in Wiesbaden**, according to which,cardiovascular diseases are the number one cause of death inGermany. In 2015, a total of 925,200 people in Germany diedfrom cardiovascular disease. These include diseases of the he-art and blood vessels, which usually lead to chronic diseasesand can have serious consequences for the affected persons.

Since no realistic 3Dmodels of humanbeings are available for re-searchers so far, they can only pre-determine human behaviour ininteraction withmedical instruments and devices to a limited ex-tent. If it were possible to simulate how a patient's heart respondsto awide range of interventions, bothpatients andhealthcare pro-fessionalswouldbe spareda lot of uncertainties - physicians suchasDr. JamesC. Perry, Professor of Pediatrics atUCSanDiego andHead of Electrophysiology and the Department of Heart Diseaseat Rady Children's Hospital in San Diego, USA, are convinced.This applies to patients with congenital heart defects who have toundergomany interventions, aswell as to the larger number of pa-tients with heart failure, cardiac arrhythmias and other structural

anomalies.

The Living Heart Project was crea-ted against this background. Aninterdisciplinary team of heartspecialists, device manufacturersand government representativeshas access to computer-assisted3D models and is thus able to ac-celerate research in medical tech-nology. The fight against cardio-vascular diseases is improved bypersonalized, virtual 3Dmodels.

The core of the project is theworld's first realistic 3D simulationmodel of a complete human heart,

developed with the simulation ap-plications of Dassault Systèmes'3DEXPERIENCE platform. TheFrench software company has beeninvolved inmedical simulation pro-jects for many years, ranging fromsimulations in vehicle design thathelp prevent serious injuries to in-vestigations into the effects of con-tact sports on the human brain.

To create a 3D model that reprodu-ces the electrical and mechanicalbehaviour of the heart in a lifelikemanner, Dassault Systèmes speci-

alists have used the functions of SIMULIA applications. It willsoon be possible to analyze the behaviour of patients' hearts wi-thout additional invasive diagnostic procedures with personal-ized 3D cardiac simulations using echocardiograms, MRI and CTimages in conjunction with data from cardiac research.

SIMULIA applications will help experts in the Living Heart Pro-ject's cardiovascular modelling and simulation expertise to solvethemost challenging challenges and their complex nonlinear be-haviour simulation capabilities to achieve the most realistic andreliable results. Dassault Systèmes' technology and the develop-ment of the LivingHeart Project aremajor advances in translatingfundamental scientific knowledge of heart function into practicalapplications that will benefit patients' health and safety.

This simulation of the human heart will be a valuable tool, not on-ly for teaching and research. The approval cycles are accelerated,reducing development costs for new andmore personalized devi-ces. It enables an earlydiagnosis with improvedtreatment results.

Author:Carola vonWendland,PRManager EuroCentral,Dassault Systèmes

Realistic 3D simulationmodel of a complete hu-man heart.

The Living Heart Projectwas developed by an inter-disciplinary team of ex-perts

CONTACT

Dassault SystemesDeutschland GmbHMeitnerstr. 8D-70563 Stuttgartwww.3ds.com/de

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Manufacturing Contract Production

The Driving Force forAdditive ManufacturingThevariety of materials and applications in plastics proces-

sing is increasing con-tinuously. This trendwas recognizedearly on by the machine engineering specialists Arburg

who, in addition to the classical injectionmolding for this growingmarket, have developed another industrial process: The ArburgPlastic Freeforming (APF) is a so-called freeformer that allows alarge amount of design freedom and material diversity and alsorealizes part geometries that normally could not be formed usinginjection molding.

Design Freedom andMaterial Diversity

The freeformer is an additive manufacturing system for produ-cing functional plastic components fromqualified standard gra-nulate either individually or in small volumebatches. It is equip-ped with two discharge units by default. This allows combiningof differentmaterials such as hard-soft combinations or the rea-lization of complex geometries. A special water-soluble supportstructure can also be used as a second component. Afterwards,the support structures are simply dissolved in a water bath. Thecompactmachine is dust and emission free. Extraction systemsor coolingwater are therefore not necessary. Thismeans that thesystem is also suitable for use in an office environment. The in-stallation space provides room for parts that have a maximumsize of 154 x 134 x 230millimeters.

From theGranulate to the Functional Component

The functional principle of the freeformer is easy to understand.„First of all, the 3-D CAD data for the component is prepared forthemachine using a special software. A functional component isthen made up from the layered geometries without tools and wi-thout reworking“, explainsMartinNeff, GroupManager for Salesand Freeform Plastics Technology at Arburg. „The granulate isthen filled into the machine and a heated plasticizing cylinderwith a special screw generates a homogenousmoltenmass out ofthis for the discharge unit. The patented nozzle shutter withhigh-frequency piezo technology enables a fast opening and clo-sing motion and generates around 200 plastic droplets per se-cond at a pressure of up to 500 bar.“

Depending on the nozzle size, the tiny droplets have a diame-ter of 0.2 to 0.4 mm. The discharge unit and the nozzle re-main in a vertical position while the piezo actuator clocks thenozzle shutter. The movable component holder is positionedby servo motors so that each droplet is placed exactly ontothe previously calculated position layer by layer. No specialprocesses or material additives are required for hardeningthe plastic; the tiny, droplets blend themselves and join toge-ther during cooling. The resulting surface corresponds to arough-structured molded part. The structure is droplet-sha-ped but smooth in every direction. The component producesby the additive manufacturing technique is ready to use assoon as it comes out of the machine.

The freeformermakes it possible to produce individual components orsmall batches from qualified standard granulates using the additivemanufacturing technique

Additive Manufacturing Proces-ses have left the prototype niche.In the meantime, all businesssectors are able to take advantageof this. Finally, it is possible to bu-ild up various different functionalcomponents layer-for-layer withtiny plastic droplets. Piezo actua-tors are the driving force and the-refore play an important role inproducing tiny droplets.

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MEDManufacturing Contract Production

A Piezo Actuator Clocks the Nozzle Shutter

The central process of additivemanufacturing is the generati-on of the droplets at the nozzle of the discharge unit.

„For generating the droplets, we decided to use a piezo ac-tuator for clocking the nozzle shutter because this providesthe necessary high dynamics and accuracy for the materialdischarge“, saysMr. Neff. The reason is the functional prin-ciple: Piezo actuators convert electrical energy directly into

mechanical energy andenable motion with sub-nanometer resolution.They achieve travel ran-ges up to approximatelyone millimeter and highdynamics with frequen-cies up to several thou-sand Hertz. The dischar-ge unit on the freeformercurrently works with fre-quencies between 60and 200 Hz, „at thatspeed, we still have somereserve“, says a very-pleasedMr. Neff.

In addition to accuracyand dynamics, the PICMAactuator from PI (PhysikInstrumente) that is used

for clocking the nozzle shutter duringthe APF process, has a number of otherfeatures that predestine it for use in in-dustrial additive manufacturing. Theactuator designed to customer specifi-cations has travel ranges up to 90 µmwith subnanometer resolution, can bepressure-loaded to 3,000 N and itsmicrosecond response time makes itexceptionally fast.

No other valve technology offers such afast response time at a comparablesize. Furthermore, PICMA actuatorssurpass conventional, polymer-coatedpiezo actuators in performance andlifetimebecause of their all-ceramic in-sulation. The ceramic insulation layerprotects the monolithic piezoceramicblock against humidity, and failure dueto increased leakage current, and the-refore achieves high motion cycles un-der extreme ambient conditions.

The monolithic structure also causes a high resonant frequency,which is the reasonwhy these actuators are ideally suited to high-ly dynamic applications. The reason that the inflexible ceramicallows this, is that the motion is based on solid-state effects. Thedynamics of the polarity reversal process are determined by theelectrical contacting and the control electronics. For clocking thenozzle shutter of the freeformer, the piezo actuator is controlledby internally developed electronics, which are integrated in thecontrol cabinet of the machine. In the meantime, the freeformerhas proven itself in various different applications in the automoti-ve and consumer sectors as well as in electronics manufacturingandmedicine technology.

Autor:Dr. Mathias Bach, Head of Product Division Piezosystems atPhysik In-strumente (PI) GmbH& Co. KG

Individually adapted implants and orthoses are an important application area for additive ma-nufacturing. The freeformer is currently able to process biodegradable PLA (polylactide) thatbreaks down slowly in the human body.

The PICMA® actuator used for clo-cking the nozzle shutter during theAPF process travel ranges of 90 µmwith subnanometer resolution, canbe pressure-loaded up to 3000 Nand its microsecond response timemakes it exceptionally fast.

CONTACT

Pysik Instrumente (PI) Gmbh &Co. KGAuf der Römerstr. 1D-76228 KarlsruhePhone +49 721 484 60www.pi.de

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MEDManufacturing Prototyping &Batch Production

By eliminating expensive in-hospitalmonitoring or the need for costlymedical procedures by providing early detection and diagnosis,wearablesmay dramatically improve the delivery ofmedical services.

Wearable Medical Devices

Medical wearables have the potential to provide betterquality data and improved monitoring compared tolarge, expensive machines located in hospitals and re-

search units. For example, today sleep apnea patients or re-search subjectsmust come into a clinic and bewired up for sleepstudies. However, people generally have trouble sleeping inrooms other than their own. A wearable medical device thatcould monitor sleep apnea metrics in a much less intrusive waycould obtainmuchmore reliable, higher-quality and longer-termdata to diagnose patients and study the effects of the disorder.

Also, consider a condition like epilepsy where known physiolo-gical changes, which occur in people over time, simply can’t bemeasured 24/7 with today’s equipment. With a wearable de-vice, a patient could be monitored for an extended period oftime, providing a much better understanding of how they inter-act with their environment and the medicines they take. Thatinformation could potentially be used to develop a predictivecapability that warns a patient when they’re about to have a sei-zure or if they are at a higher probability of having a seizure.

Types of Devices

There are four primary types of wearablemedical devices, ran-ging from the simplest to themost complex: passivemonitors,surveillancedevices, diagnostic devices and therapeutic devi-ces. Of the latter three, surveillance is the simplest. Movingalong the continuum from surveillance to therapeutics, bar-riers to commercialization increase. Surveillance devicessimply report, while diagnostic devices make decisions andtherapeutic devices make decisions and treat the patient.

Diagnostic devices carry a higher level of legal risk than do sur-veillance devices because they find problems and medical de-cisions are being based on the data they produce. Therapeuticdevices take that risk to an even higher level because they treatthe condition.Most therapeuticwearable devices are still in theresearch phase andwould have to be approved asmedical devi-ces by the FDA, making the development cycle much longer –particularly if a company is developing a drug/device combina-tion. Monitoring devices make sure that diagnostic and thera-peutic decisions and procedures have been done correctly.

Development and Design

Two key factors in wearable medical device design are ease ofuse and patient comfort. They are typically determined by howthe electronics are configured and what type of materials areused to fabricate the electronics. Use of rigid materials mustbe minimized so the device can conform to the body and sur-vive bending during normal humanmotion.

As a result, designers and component suppliers must first un-derstand the use scenario. For example, where would the wea-rable device be applied –wrist, chest, elbow, lower back, or el-sewhere? How will it be used – once a day and then replaced,or for a week or more before being replaced? Understandinguse scenarios includes asking questions such as these:

+ How does the device need to function electronically?

+ Will the devices include wireless interfaces to supporttelehealth andmHealth applications?

+ At what intervals does it need to collect data for the diffe-rent metrics being monitored?

+ How is that data stored?Does the device access a local sto-rage site or does it communicate with the Cloud?

Because skin contact is involved in most wearable applicati-

Wearable for the purpose of monitoring vital parameters of a patient

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ons, special adhesives or other fastening means must be inc-luded in the design. The adhesives must not cause any skinirritation and should account for varying patient sensitivities.Fortunately, a wide range of biocompatiblemedical adhesivescan be used with the choice of adhesive depending on a num-ber of factors, including the length of time the device is goingto beworn – for example for 15minutes or seven days. Anotherconsideration is if the wearer will be exposed to water or if theywill shower with the device on.

Types of Electronic Circuits

The choice of electronics for medical wearables typically inc-ludes traditional PCBs, copper flex circuits, printed electro-nics, antennas, fine wires or combinations thereof. PCBs,being rigid, are typically appropriate for applications such assmart watches and wellness-type devices that tolerate theform factor and its rigidity.

Flexibility is a key advantage of etched copper flex circuits be-cause it enables improvement in form factor relative to rigidPCBs. Complicated components such as microcontrollerswith high I/O counts and other fine-pitch devices can be atta-ched to copper flex substrates. While these packaged deviceslimit the flexibility and conformability of the overall circuit,they canmeet many performance requirements.

Copper flex circuits are fabricated in a subtractive process bytaking sheets of copper laminates, masking the desired con-ductive paths and then chemically removing all unwantedcopper, leaving thedesired circuit patterns. This is followedbycomponent attachment, as discussed above. While copperflex circuits remain a key part ofmanymedical devices, in cer-tain applications they may have issues with biocompatibilityas well as failure due to repeated bending cycles.

Additive manufacturing techniques are used to create the basecircuit in printed electronics. Typically, silver, silver chloride, car-

bon and dielectric materials are printed on a variety of substratesthat can be chosen for biocompatibility. The materials and themanufacturing process contribute to making base circuits thatare extremely flexible and able to withstandmany bend cycles.

In addition, certain substrates and printed materials can bestretchable, offering additional robustness for applicationswhere patient motion is involved. The substrates and manu-facturing approach for the base circuits can often provide costbenefits compared to copper flex circuits. As with copper flexcircuits, components can be attached to the printed electro-nic base circuits, enabling high performance devices. As a re-sult, many wearable medical device designers are evaluatingprinted electronic solutions to leverage these advantages.

Choosing the right circuits for a medical device is not a zerosum game. There are some wearable applications where adesigner could combine all three types of circuits, or usecopper flex circuits and printed electronics in the same pa-ckage to provide functionality and still meet the device’scost target.

Converting and Packaging

There aremanydifferent converting techniques forwearablemedical devices and the choice depends on what the finalproduct should look like and feel like. Medical convertingcan be performed in sheet-based or roll-based forms. Thelatter is generally more applicable to higher-volume pro-ducts. Also, roll-to-roll medical converting substantially re-duces the labor component of converting and packaging,and multiple rolls of materials can be joined and laminatedtogether on the machine.

The converting process can include die-cutting, laser cutting,slitting, island placement and lamination – all in a continuousoperation in the case of roll base converting. Often, multipleunits of the same product are created on each sheet, in thecase of sheet based converting, or on repeat length, in the caseof roll based converting. Those products are then singulatedinto individual products, packaged, stored and shipped.

Roll-to-roll converting can also be combined with more costlysheet converting: After beginningmedical converting ona roll-to-roll process, the rolls can be sliced into sheets, with the fi-nal converting steps performed on a sheet-to-sheet basis.

Sheet-based converting is non-continuous and throughput is ty-pically lower than in roll-to-roll converting.However, some sheet-based converting processes can be more accurate than roll-to-roll. Choosing the right process for a particularwearable dependson required throughput, accuracy, device cost and other factors.For example, if a manufacturer is performing roll-to-roll medicalconverting and device volume is not high enough, scrap and set-up will drive unit costs higher. In that case, a sheet manufactu-ring process might be more appropriate.

For the electronics of medical devices a number of suitable produc-tion methods are available. Shown is here left to right the traditionalPCB approach, copper-flex-approach and printed electronics.

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Software Component

Software is another key wearable medical device component.Thedevicemanufacturer typically has the informationneededto develop the software, including intimate knowledge of thepatients, the type of physiological metrics being monitored,how changes in metrics affect the patient, and how that datacan be used to inform caregivers.

Because wearable medical device analytics is a relatively newfield, software developers are creating systems that can trans-late patient knowledge into new algorithms and data analysisfor highly specific applications. Also, antennae and mobiletechnologies, such as those provided by Molex, can be part ofcomplete wearable medical solutions, a product group thatincludes smartphone-controlled devices. Close collaborationamong device manufacturers, software developers and elect-ronics providers is essential to make sure software meets theneeds of the user.

For example, physiology analytics can be used to analyze therelationship among between physiological signals such asblood pressure, heart rate, respiration rate and others, provi-ding continuous monitoring and alerts when needed.

Using Manufacturing Partners

When all the pieces are in place, there are several options forfinal wearable device assembly. If the developer controls allaspects of the design, a contract manufacturer can build thedevice based on design specs. On the other hand, most wea-rable medical devices require a collaborative design processthat includes manufacturing partners.

In those cases it is essential for device manufacturers to workwith partners on all aspects of device commercialization, fromdesign through manufacturing. Most wearable device marke-ters do notmanufacture the electronics that power these devi-ces, so partners typically play an outsized role in developingand manufacturing the devices. The partners help customersdesign devices, move them through prototypes stages, selectthe most appropriate technology, and support them throughregulatory approval by the FDA or other regulatory bodies.

In the case of wearable medical devices, which are relativelynew products, a great deal of expertise resides outside of thedevice manufacturer. There is a long history of devices beingmanufactured for medical companies by manufacturing part-ners such as Molex. What companies like ours bring to thetable is a deep understanding of how devices need to functionand interact with the human body as well as the required ma-nufacturing techniques and how to optimize and combinethem appropriately to provide the most efficient manufactu-ring solution. This synergistic relationship can provide a criti-cal comparative advantage for device manufacturers thatwant to bring the best possible solution to the market.

ANTIMICROBIAL COATEDKEYBOARDS

Diamond Electronics now offers a wide range of antimicrobial coated, easy toclean keyboards which are dishwasher safe. The keyboards and accessoriesare Intended for use with clinical and home use medical systems, clean in-dustrial applications including food processing, semiconductor manufactu-ring and laboratories, POS systems and public area data input and control.The iMTC range of sealed keyboards are waterproof to IP68, easy to clean andmay be washed in a dishwasher. The keyboards meet medical approvalEN60601-1-2 and can be supplied with an approved antimicrobial coating,

nano silver or ionic silver antibacterialtechnology.

Options include full QUERTY keyboardswith either number pad or tracker pad,small footprint keyboards with integralpointing device, number pad keyboards

with pointing device and a mouse with touch-scroll. Optional adjustablebacklighting, and keyboard on/off switch are available and the devices maybe connected to host systems via USB cable or wireless link.

www.diamondelec.co.uk

A scalable sensorplate with flexible form factor

CONTACT

Molex Deutschland GmbHOtto-Hahn-Straße 1bD-69190WalldorfPhone +49 6227 309 10www.molex.com

83


MEDProthetics Endo- and Exoprothesis

Theranostic Implants

Latest knowledge inmedicine are also included as the re-sults of materials science, electrical engineering, bio-chemistry, signal processing and computer science.

Detection of specific vital parameters is the diagnostic refe-rence for therapeutic treatment. Efficiency of this initiatedtreatment is optimized in a closed feedback loop with measu-rements of the implant. The importance of theranostic is cur-rently growing due to its diverse application possibilities. De-mands on quality of highly specialized medical care and thedemographic change are increasing.

Theranostic implants have achieved a social relevance leading toan innovation leap inmedical technology in the context of futuretechnological possibilities. For quite a while individual Fraunho-fer-institutes are making already significant contributions tosuch innovation based on the combination of multiple technolo-gies at a high level. Fraunhofer-Gesellschaft is able to take a lea-ding position by concentrating these different activities in keytechnologies that are important for theranostic implants.

Therapy and Diagnosise in One

This prototype described here is an implant for controlling amyoelectric hand prosthesis with at least six degrees of free-

dom and a sensor feedback. The primary purpose of an myoe-lectric armprosthetics is tomimic the appearance and replacethe function of a missing limb.

Signals are tapped in a multichannel manner from the musc-les to control the prosthesis. Gripping force feedback of the ar-tificial hand is transmitted to the person via an electronic sti-mulation of the sensitive nerve fibers. It facilitates the controlof the prosthesis and also allows complex movements.

Application-specific integrated circuits (ASIC) were develo-ped at Fraunhofer IIS in Erlangen to detect electrical activityof muscles and to stimulate the nerve fibers.

Design Challenges

Implant size is the biggest challenge determined by the posi-tion within the body and it is already defined before the begin-ning of the actual development. Designers are influenced toachieve the intended design ultimately to reduce implantfunctionality or to choose an extremely compact design.

Electronics is used to control the hand prosthesis with activefeedback to the ASICs. Installation space for electronics wasalready predetermined in advance by the size and shape of thetitanium housing with enclosing silicone encapsulation. Opti-mal use of installation space could only be achieved by const-ructive measures in housing design or by component shifts orcomponent selection.

Myoelectric Hand Prosthesis

Theranostic implants are com-plex, multifunctional, implan-table medical devices thatcombine therapy and diagnos-tics in one medical system.Fraunhofer-Institute for Integ-rated Circuits IIS conducts re-search and development inmultidisciplinary cooperationin this field.

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Images:FraunhoferIIS


MEDProthetik Endo- and Exoprothesis

Common practice of building up a prototype for thefirst time in order to keep all possible degrees of free-dom open and to communicate with the outside worldvia various connectors could not be achieved here. Theonly concession to additional components was a de-bug plug via a flexible connection, which is separatedafter the firmware has been programmed.

Therefore, all the available variants had to be accom-modated on the implantable board with the dimensi-ons of approx. 21 x 26mm. A cut out with a size of ap-prox. 4 x 8.5mm is present in themiddle of the circuitboard which removes additional wiring area.

The prototype had to include the following possible va-riants of a later product:

+ Inductive charging of the internal energy buffer

+ Optional communication via optical interface or

+ Communication via RF

+ Choice of external signals via contact pins in flex or

+ External signals can be fed via fold-in soldering lugs

Used CAD Software

For the given task PCB design software from Cadence wasused. “With Constraint Manager of Allegro PCB Designer ver-sion 16.6 all required restrictions and design rules could beprecisely defined and verified during the design process“ saidAlfred Holzberger, Senior PCB Designer of Fraunhofer IIS.

„The very comprehensive yet manageable Constraint Mana-ger makes it possible to define all the necessary electrical,

physical and distance-related rules in a layer-specific man-ner like geometrical parameters for impedance control,adapted cable lengths for individual signals or buses, keepouts, etc.“ Design rules are checked continuously in the PCBEditor, and the user immediately receives a feedback if he vi-olates rules. This ensures that the user is able to quickly finda correct solution.

Themechanical housing design already existed and could on-ly be modified within very narrow limits. Electronics and me-chanics had to be adapted to each other in several iterationsand data exchange for collision tests with highest accuracy inMCAD software Inventor.

Technical support for PCB tools, provided by FlowCAD, isparticularly important when implementing new and complextechnologies.

Variant for optical communication with detachable debug-connector and sol-der contacts

PCB is fitted into a 3D prototype housing

CONTACT

FlowCADMozartstr. 2D-85622 FeldkirchenPhone +49 89 45 63 77 70www.flowCAD.com

CONTACT

Fraunhofer IISAmWolfsmantel 33D-91058 ErlangenPhone +49 9131 776 47 12www.iis.fraunhofer.de

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Index/Masthead

www.med-eng.de

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MEDengineering INTERNATIONAL 2018 86

AdvertisersAEMtec GmbH, Berlin 47Bürkert Werke GmbH, Ingelfingen 41Cicor Management AG, Zürich/CH 61comité EPMT/EPHJ, EPMT, SMT, Genf/CH 2congatec AG, Deggendorf 19Coroplast Fritz Müller GmbH, Wuppertal 75CPC Colder Products Company GmbH, Großostheim 7Data Modul AG, Munich 11Dr. Fritz Faulhaber GmbH & Co. KG, Schönaich 88Edmund Optics GmbH, Karlsruhe 69ENEMAC Gesellschaft für Energie- und Maschinentechnik mbH, Kleinwallstadt 51First Sensor AG, Puchheim 3FLUID Metering, Inc., NY/USA 35Innovative Europe ApS, Copenhagen/DK 9Magnet-Schultz GmbH & Co. KG, Memmingen 57Maxon Motor AG, Sachseln/CH 1Micro Systems Technologies Management AG, Baar/CH 5

Mikrop AG, Wittenbach/CH 55Ming Tai Industrial Co., Ltd., TAMSUI TAIPEI/TWN 13NürnbergMesse GmbH, Nuremberg 21Ocean Optics BV, Ostfildern 67Rico Elastomere Projecting GmbH, Thalheim /Wels/A 37Rosenberger Hochfrequenztechnik GmbH & Co. KG, Fridolfing 49Sphinx Werkzeuge AG, Derendingen/CH 23TAITRA, Taipei/TWN 29TDK-Lambda Germany GmbH, Achern 15TQ-Systems GmbH, Seefeld 17

IndexAnalog Devices GmbH 68Basler AG 40Ceram Optec GmbH 48Christian Bürkert GmbH & Co. KG 32Dassault Systemes Deutschland GmbH 78Data Modul AG 50Diamond Electronics Ltd. 83Dynetics GmbH 16

Eisele Pneumatics GmbH + Co. KG 34ENEMAC 18EURECA Messtechnik GmbH 65FlowCAD EDA-Software Vertriebs GmbH 84Fluid Metering, Inc. 36Fraunhofer IIS 84FTCAP GmbH 63Ges. für WolframIndustrie mbH & Bayerische Metallwerke GmbH 43Haseke GmbH & Co. KG 56Heraeus Medical Components 45Igus® GmbH 53ITK Engineering GmbH 76Koco Motion GmbH 12Matrix Vision GmbH 58maxon motor ag 8Molex Deutschland GmbH 81Odu GmbH & Co. KG 26Orderfox 55Physik Instrumente (PI) GmbH & Co. KG 79RK Rose+Krieger GmbH 38Rodriguez GmbH 24Rosenberger Hochfrequenztechnik GmbH & Co. KG 20

Sensirion AG 28Softgate GmbH 71System Industrie Electronic GmbH 6 TQ-Systems GmbH 60WIBU-Systems AG 73

AuthorsBernd Klöpper 38Carola von Wendland 78David Bennet 68Dr. Jochen Furthmüller 76Dr. Mathias Bach 79Dr. Michael Schwarz 76Herbert Wurm 20Jens Trötzschel 45Markus Sabin 71Nicole Dahlen 24Oliver Winzenried 73Peter Behringer 40Richa Sharma 50Richard DiAngelo 68Stefan Roschi 8Susanne Jungmann 28Ulf Hottung 53Ulli Lansche 58Yvonne Fischer 60

MAstheAd

Short descriptionMED 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.

PublisherMediengruppe Oberfranken –Fachverlage GmbH & Co. KGE.-C.-Baumann-Str. 595326 Kulmbach/GermanyPhone +49 (0) 9221/949-311Fax +49 (0) 9221/949-377 www.med-eng.de

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Advisory BoardProf. Dr. Armin Bolz, Corscience;Kurt Eggmann, Weidmann Plastics;Dr. Thomas Feldmann, DQS Medizin produkte; Prof. Dr.-Ing. Petra Friedrich, University in Kempten, Germany;Theodor Lutze, Surgical Innovation Consulting;Prof. Dr. Peter Schaff, TÜV SÜD;Oliver Winzenried,WIBU-SYSTEMS AG

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ISSN 2190-8788

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Descriptive NamesThe 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.

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Professional knowledge for Developers and Designers of Medical Devices – quali� ed, practical and up-to-date!

The trade journal MEDengineering supports developers and designers of medical devices in their daily work.

MEDengineering provides important news from following areas:

· medical electronics

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· development of endoprostheses and exoprostheses

· metrology

· software tools

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