www. med-eng.de/international

Transcription

www. med-eng.de/international
MED engineering INTERNATIONAL 2013
2013
w w w. m e d - e n g . d e/i n t e r n a t i o n a l
36 RoHS + REACH
Mandatory: E10 in
medical electronics
38 Titlestory:
Small DC-motor
with high-impact
52 CFR Polymers
How to switch from
metal to CFRP?
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Note of the Editor
K
eeping pace with the demographic shift was the subject at MED
engineering’s forum at the electronica 2012 in Munich. During the
discussion it became clear that the main challenge of the demographic shift in health care industry is certainly to close the growing gap
between the increasing demand of medical aid and the decreasing number of medical staff as well as the decreasing number of tax and health
insurance payers. This gap is not only raising ethical questions, e.g. ›who
is going to care for the elder?‹ but also ›who will be able to pay health care
costs in future‹? As a consequence cost pressure on everything and everybody in the health care industry will increase. Nearly every country is looking for ways to get health care cost under control. Even in the US where
margins for medical products are much higher than elsewhere cost pressure will increase.
Coping
with the
demographic
shift
Qseven™
MSC Q7-TI8168
Texas Instruments ARM CortexA8 with integrated DSP core
Innovative combination of ARM Cortex-A8
RISC MPU with the TI C674x DSP core.
A powerful module especially suited for
vision, imaging, test and control.
From a technical point of view MedTech industry faces this challenge by
developing, for example, mobile devices that can be used by several physicians in a health care center (page 35). Further ideas are home care solutions and wearable technology. Both technologies are available but not
in every day use. One reason is that they require a wireless IT infrastructure in order to connect the mobile devices with the patient’s electronic
medical records. IT departments in hospitals or health care centers have
to invest money but do not know whether these new technologies will be
refunded. According to IDC Health Insights, there will be no savings without these investments. Other tendencies require investments too. Sustainability (page 36) of medical electronics for example or changes in regulation. Medical products might become more expensive in the end. The
conclusion of the MED engineering forum therefore was that a supporting refunding policy is needed.
Taking into account that the world’s population amounts to over 7 billion
people today and is expected to count 7.7 billion in 2020, politicians should
also start to think of a global demographic policy. Education and migration of young people from countries with high birth rates could be a way
out of this spend-money-to-save-money-game.
3
ƒ Texas Instruments
-ARM Cortex A8 CPU up to 1.2 GH
-DSP Subsystem C674x up to 1.0 GHz
ƒ1 GB DDR3 SDRAM
ƒ2 GB Flash SSD soldered on board
ƒGigabit Ethernet
ƒOne PCI Express x1 port
ƒHDMI/DVI up to 1920x1080
@ 75 Hz resolution
ƒSingle Channel LVDS 24 bit
up to 1280x720 @ 60 Hz
ƒDual Independent Display support
ƒTwo SATA-II interfaces
ƒSix USB 2.0, HD Audio
ƒLinux support
(WinCE and Android on request)
V-11_2012-WOEI-6298
Erika Fuchs, Editor in Chief
fuchs@hanser.de
Qseven™ MSC Q7-TI8168
MSC Vertriebs GmbH
Tel. +49 8165 906-122
boards@msc-ge.com
www. msc-ge.com
Contents
Signal Transmission
via Radio Waves
In the operating theatre, medical
devices with controls communicating via radio waves are
increasingly common. This technology offers considerable
advantages but demands high
signal reliability.
12
Contact:
Sophisticated Drive
Systems for Tomorrow
Editor-in-Chief
Erika Fuchs
Tel. +49 89 99830-626
Assistant
Gabriele Wieser
Tel. +49 89 99830-231
Advertisement Manager
Martin Ricchiuti
Tel. +49 89 99830-686
Publisher
Carl Hanser Verlag GmbH & CO. KG,
Kolbergerstraße 22,
D-81679 München
www.med-eng.de,
E-Mail: med-eng@hanser.de,
Fax +49 89 99830-126
Motor controllers are often
based on user-specific circuits.
However, complex applications
can be developed more
efficiently and economically on
FPGA platforms.
33
Advisory Board
Plastic Couplings are a Safe Bet
Rainer Birkenbach, BrainLAB;
Prof. Dr. Armin Bolz,
Corscience;
Kurt Eggmann,
Weidmann Plastics;
Prof. Dr.-Ing. Petra Friedrich,
University, Kempten;
Theodor Lutze, Aesculap;
Prof. Dr. Peter Schaff,
TÜV SÜD;
Dr. Timo Schirmer
GE Healthcare;
Sigrid Uhlemann,
DQS Medizinprodukte;
Prof. Dr. Dr.
Erich Wintermantel, University,
Munich (TUM)
MED engineering INTERNATIONAL 2013
Plastic couplings do not only
guarantee a save connection at
room temperature but also at
high temperatures in autoclaves for
example or at very low
temperatures in cryotherapy.
54
4
© Carl Hanser Verlag, Munich
MED Devices
16 Sensors in Medical Technology
Modern sensors and measurement systems make medical
devices more secure
18 New Products
Telescopic Pillars for opthalmology and infant care
36 E10 in Electronic Medical
Technology
By June 2014 medical device
manufacturers have to demonstrate the compliance of RoHS 2
and REACH
MED Prostheses
38 Trusting the Next Step
With the right leg prosthesis,
being active can be part of dayto-day life again
20 Small, Fast, and Precise
Neither magnetic fields nor
humidity or vacuum influence
piezoelectric drives
24 Finished Parts Within Ten Days
Rapid injection moulded parts
open up new perspectives in the
world of regenerative medicine
26 New Products
Quad Lock connectors enhance
diagnostic functionality
28 Process Safety in Laboratories
Sensors make sure that processes are reliable, precise and
efficient
41 New Products
Long-lasting hygiene with antimicrobial cables
46 New Products
Micro-Spaghetti Tubing with thin
and stable walls
MED Informatics
42 Developing Safety-Critical
Software
If development of the software
is model-based, it helps developers of safety-critical devices to
meet legal requirements
MED Materials
48 The Way to Perfect Catheters
Whether multi-lumen catheters
will be a success depends on a
precise specifications
52 Surgical CFRP Instruments:
More than Radiolucent
To switch from metal to CFRP
requires an experienced engineering and manufacturing partner
51 New Products
Electronically variable
optical diffusers
MED Electronics
CONFOCAL
TECHNOLOGY
FOR MEDICAL
ENGINEERING
Nano-resolution for displacement
and thickness measurement
30 ARM and DSP Ensure
Rapid Imaging
Digital signal processors improve
image processing and quality in
ultrasonic and X-ray applications
35 Measuring the Speed of
Blood Flow in Real Time
With a Micro-ATX board digital
Doppler and duplex sonography
come in one device
NEW
ƒ Fast measurement on changing surfaces
ƒ For high precision measurements
Service
03
06
10
58
Note from the Editor
MedTech News
MedTech Events
Masthead/Index
ƒ World’s fastest controller
(70kHz xenon / 10kHz LED)
ƒ EtherCAT, Ethernet, RS422 and analogue
ƒ Smallest spots for tiny objects
ƒ High resolution and independent
of the material surface e.g. Diameter
measurement of stent wire
Titlepage Advertising
Trusting the next step
The maxon motors built into the
prosthetic leg ensure smooth
operation of the hydraulic system
of the C-Leg. This allows the user
to carefreely play soccer and
climb stairs. (Photo: Otto Bock)
Whereever maximum power is
needed in the smallest places,
maxon motor’s precision motors
are employed. We serve a variety
of specialized markets within the
medical industry, such as diagnostics, therapy, prosthetics and
laboratory technology.
maxon motor ag
Brünigstrasse 220
CH-6072 Sachseln
Phone +41 41 666 15 00
www.maxonmotor.com
www.micro-epsilon.com
5
MICRO-EPSILON | 94496 Ortenburg / Germany
MED engineering INTERNATIONAL 2013
Tel. +49 85 42/168-0 | info@micro-epsilon.com
The Center of Attention was the central meeting point at the first
World Medtech Forum in Lucerne
Successful Start
Next World Medtec Forum in the new trade fair center. According
to the organizers the first World Medtech Forum (WMTF), held from September 25 to 27 in Lucerne (Switzerland), has been a success. It provided a
mix of international suppliers, latest developments in Swiss medtech research
and inputs from the medical technology sector. Around 3200 people, 20 percent of whom had travelled from abroad, attended the WMTF. The international character of the forum was further underscored by the visit of a delegation of Russian healthcare specialists and the presentation on Bavarian
medtech companies organized by the German-Swiss Chamber of Commerce.
The congress attracted some 300 attendees. The high standard of the lec-
tures and presentations given by the 150 top-class medtech experts in the
various WMTF venues met with universal acclaim. Exhibitors, visitors and
speakers grasped the opportunity to network and share experience with renowned experts, and to discuss current issues in the workshops – even doing
so at international level. Peter Biedermann, Managing Director of the Swiss
Medical Cluster expressed his satisfaction: »We wanted a quality event, and
that is what we got. It has been a successful start and timing was ideal. The
medical technology sector has taken this chance to spend four days discussing the opportunities and challenges facing it.«
The central meeting point at the trade fair was the Center of Attention – a
platform for informal and interdisciplinary exchange between research institutes at hospitals, universities, universities of applied science and the medical technology industry. The 50 lectures in the auditorium integrated into the
center were well attended. The WMTF’s partners and the medtech industry
are unequivocally in favor of repeating the WMTF in 2013. So the next WMTF
will be held from September 17 to 19, 2013 at the Lucerne trade fair center.
The new trade fair site will have been completed by this time and will be of
the highest standard. The compact, modern infrastructure is exactly in line
with the WMTF’s quality strategy, which is geared to moderate growth and
maximum exhibition quality. The current successful formula of congress,
trade fair and meetings will also be retained.
www.medtech-forum.ch
Photo: Erika Fuchs; CHV
MedTech News
Watlow Receives Löhn Award
Steinbeis Foundation awarded transfer of highly dynamic variothermal technology
MED engineering INTERNATIONAL 2013
The Steinbeis Foundation has awarded its 2011 Löhn Award to
Watlow, the Steinbeis Center for Plastics and Sony DADC
jection molding process. This solution has been successful in the
commercial environment by Sony DADC, incorporating it into
large-scale production.
This collaborative project started in 2009, and allowed the sharing
of specialist knowledge in commercial microfluidic chip production, thermal systems and the properties of plastic areas between
Sony DADC, Watlow and Steinbeis respectively.
www.watlow.com
6
© Carl Hanser Verlag, Munich
Photo: Uli Regenscheit (Stuttgart)
The Löhn Award has been awarded annually since 2004, in honor of
Prof. Dr. h. c. mult. Johann Löhn who was instrumental in the technology transfer aspect of the Steinbeis Company. This year the award
went to Watlow, the Steinbeis Center for Plastics and to Sony DADC.
In a joint transfer project between the three, the high dynamic variothermal (HDV) technology was developed and introduced and allows producing micro structured components in medical technology. In order to make this technology possible, Watlow developed
a thermally sprayed electrical heating system for highly dynamic
variothermal temperature modules as well as the necessary control
system.
The potential of lab-on-chip technology in medical science is enormous, but the price of the chips is holding back some research.
The exacting standards of the equipment cause production techniques to be complex and costly, with the single-use nature of the
device further adding to this. Cost-effective mass manufacturing
of these components is central to seeing the potential of this technology maximized by a variety of different areas within the bioscience and pharmaceutical industries. Applying the technology
developed by Watlow, a company designing and manufacturing
thermal solutions, and the Steinbeis Transfer Centre for Plastics,
Sony DADC BioSciences have refined the manufacturing process
for plastic chips, using injection molding, to great effect. Taking
advantage of Watlow’s thermal expertise, they were able to meet
the standards expected of the chip’s performance during the in-
Photo: Bayer HeathCare
Positioning Systems
FOR MICROSCOPY
Bayer HealthCare
acquires Radimetrics
Leadership in medical information technology
Bayer HealthCare, a subgroup of Bayer AG with annual sales of
EUR 17.2 billion in 2011, is a supplier of healthcare and medical
products and is based in Leverkusen, Germany. The company announced End of November 2012 that it has entered into a definitive acquisition agreement with the principals of the privately-held
Radimetrics Incorporation, to purchase all shares of the company.
Toronto-based Radimetrics develops healthcare software and has
introduced software to accurately measure a patient’s radiation
exposure over the course of multiple imaging procedures. The
software, eXposure, is also a very powerful quality assurance and
improvement platform that includes the ability to define and
manage scanner protocols.
Financial details on the agreement were not disclosed. »This is a
strategic acquisition as Bayer moves its Radiology & Interventional business forward to be the end-to-end provider of products,
solutions and service for the radiology customer,« said Alan Main,
Head of Bayer HealthCare’s Medical Care division.
Radimetrics employees in Toronto and Scotland will become employees of the Bayer group, expanding the company’s existing informatics group in the Radiology & Interventionals organization.
Founded in 2009, Radimetrics’ flagship product, eXposure, integrates with existing imaging and patient information technology
storage systems (i.e. PACS/RIS ) to provide a single system for tracking patient radiation exposure across imaging modalities. The software has been used in many commercial hospital groups and other
medical delivery organizations in North America and a growing
number in Europe. According to Alan Main, »Bayer Healthcare’s
Radiology & Interventional is well positioned as a leader in the industry to accelerate broad market adoption of eXposure to new
customers who are looking for ways to better leverage technology and improve radiation dose monitoring accuracy. The combined strengths of our informatics platforms will drive future innovative customer solutions.«
Gregory Couch, President and founder of Radimetrics, said: »Today’s
agreement is a new chapter in a great alliance which began earlier
this year. Radimetrics has been committed to developing innovative
software that focuses on patient’s safety, quality and productivity in
medical imaging. We feel that Bayer Radiology & Interventional is well
positioned to continue this commitment and I’m excited to join the
organization and work to make this happen.«
www.healthcare.bayer.com
P-545 – Dynamic
Motion in 3 Axes
Travel ranges to 500 μm
Resolution in the nanometer range
Response time in the range
of a few milliseconds
M-687 – Low-Profile,
Precision XY Stage
Travel ranges to 135 mm
Minimum incremental
motion up to 0.1 μm,
highly stable
Velocity to 120 mm/s
PIFOC® – Scans and
Positions Objectives
Travel ranges to 1 mm
Resolution in the nanometer range
Minimum settling time
Positioning systems from PI are particularly suited for
the most challenging applications in microscopy, life
science, biotechnology or medical technology. They
offer subnanometer resolution, large travel ranges and
they are extremely fast. For more information, contact us:
info@pi.ws · www.pi.ws
Physik Instrumente (PI) GmbH & Co. KG · Tel. +49 (721) 4846-0
PIEZO
NANO
PI-MICROSCOPY
pi_120973_kombi_m2_85x250_en.indd 1
7
POSITIONING
26.11.12 12:20
MED engineering INTERNATIONAL 2013
Medica and Compamed 2012
More economic solutions and strong focus on ergonomics
130 600 visitors came to
Dusseldorf, Germany in order
to attend the medical trade fair
MEDICA and about 16 000 visited the supplier’s exhibition
COMPAMED which both took
place from 14th to 16/17th November 2012. »MEDICA is a true
reflection of the market. Tight
health care system budgets
worldwide prompt more and
more commercial departments and sickness funds to
intervene in investment decisions,« explains Joachim Schäfer, Managing Director at Messe
Dusseldorf. Due to the cost
pressure characteristic of nearly all predominantly state-financed health care systems
not only high-end technology
solutions are in demand. Users
also ask for robust, affordable
products and systems for the
widest possible spectrum of
use. An example are medical
imaging systems such as ultrasound. Vendors have started to
equip medium-priced equipment with advanced imaging
technologies and ultrasound
probes that were previously
only available in the up-market
segment of devices. Additionally, updates make for new operating functionalities without
having to exchange the whole
system for a new device.
One focal theme was Health IT.
There is rising demand for
compact solutions for a better
networking of health care players, such as for the data transfer amongst physicians and
between physician and patient. Tablet PCs or smartphones are therefore on the
advance in surgeries and hos-
pitals, as are the so called
›Apps‹. One overview of useful
health Apps was provided by
the ›AppCircus‹ of the company dotopen at the IT FORUM in
Hall 15. If more and more digital data is available the question of safe data storage arises,
especially when talking about
data storage by Cloud computing. Therefore the question of
which medical data is permitted to be stored on external
processors, which legal aspects
need to be taken into consideration and, above all, which medical benefits can be derived
from storing data in the Cloud
received plenty of attention in
the lectures and discussions at
the IT FORUM.
Held in parallel with MEDICA
was COMPAMED, the trade fair
for suppliers to medical device
manufacturers with 645 exhibitors from 34 nations. In the exhibition halls 8a and 8b over
16 000 visitors came to convince themselves of how closely the upstream suppliers cooperate with medical device
manufacturers in terms of product development today. Suppliers are increasingly focused
on ergonomics. Be it ultrasonic
equipment, OR workstations or
patient monitors – despite continuous performance improvements in medical devices their
handling is getting constantly
easier. This is made possible by
modern touch-screen GUIs and
intuitive menus as customized
by some exhibitors. The trend
towards miniaturisation, ever
more compact and yet more
complex systems, e.g. tiniest
components for so-called lapon-a-chip applications, was the
theme at the booth of IVAM – Association for Microtechnology.
Current supply market trends
were also addressed at the two
technical forums integrated into COMPAMED, which specifically targeted experts for manufacturing processes and product
development.
Photo by Messe Düsseldorf
MedTech News
www.medica-tradefair.com
www.compamed-tradefair.com
Low-cost Camera
cleaning procedures after every useage are time-consuming. This problem might
be solved by the microcamera that the Fraunhofer Institute for Reliability and
Microintegration (IZM) in Berlin, Germany has developed with Awaiba and the
support of the Fraunhofer Institute for Applied Optics and Precision Engineering IOF. Because of a new manufacturing process microcameras can be produced at such a low price that doctors can dispose the endoscopes after the
first usage. Digital camera systems consist of a lens and a sensor that transforms
the image into electrical signals. Electrical contacts on the sensor allow access
to these signals and to the information of the image. Due to the way they are
manufactured, these contacts are located between the sensor and the lens. The
sensors are manufactured simultaneously in large numbers, like computer chips.
About 28 000 image sensors fit onto one wafer and until recently, each was sawed out, wired and mounted on the lens. The researchers have streamlined
MED engineering INTERNATIONAL 2013
this process by developing a new way to access the electrical contacts. Now, the
wiring process is faster and the camera system smaller. Contacts of each individual image sensor are no longer reached via the side but, simultaneously, with
all sensors via their reverse side while they are still connected as a wafer. The lenses no longer have to be mounted. Instead, they can be connected with the image
sensor wafers as lens wafers. Afterwards the stack of wafers is sawed apart into
individual microcameras. The camera supplies razor-sharp pictures even in thin
endoscopes and has a size of 1.0 x 1.0 x 1.0 millimeters. www.fraunhofer.de
8
© Carl Hanser Verlag, Munich
Photo: Fraunhofer IZM
Disposable endoscopes now affordable. Endoscopes are expensive and
INTERNATIONAL TRADE SHOW
HIGH-PRECISION LEADER
WATCHMAKING AND JEWELLERY - MICROTECHNOLOGIES – MEDTECH
WWW.EPHJ.CH
MedTech Calender 2013
MedTech Events
Arab Health
International exhibition
and conference
www.arabhealthonline.
com
January 28 – 31, 2013
Dubai, United Arab Emirates
MEDTEC UK
European medical device
manufacturing industry,
trade fair
www.medtecukshow.
com
May 1 – 2, 2013
London, UK
LASER World of
PHOTONICS
Trade fair for optical
technologies
www.world-ofphotonics.net
May 13 – 16, 2013
Munich, Germany
CISOP
Rapid.Tech
International interdisciplinary congress and fair
about dental
www.ciosp.com.br
Jan. 31 – Feb. 3, 2013
Sao Paulo, Brazil
Trade fair and users
conference for rapid
technologies
www.rapidtech.de
May 14 – 15, 2013
Erfurt, Germany
IS&T/SPIE Electronic
Imaging
International forum for
digital imaging systems
www.spie.org/x16218.xml
February 3 – 7, 2013
San Francisco, USA
SPIE Medical
Imaging
CMEF Spring 2013
MEDTEC France
International fair about
medical equipment
www.cmef.com.cn/en/
index.html
April 17 – 20, 2013
Shenzhen, China
European medical device
manufacturing industry,
trade fair
www.medtecfrance.com
May 15 – 16, 2013
Lyon, France
Medica
World forum for
medicine
www.medicatradefair.com
November 20 – 23, 2013
Dusseldorf, Germany
Compamed
International trade fair –
high tech solutions for
medical technology
www.compamedtradefair.com
November 20 – 22, 2013
Dusseldorf, Germany
Med-e-tel
Orthotec Europe
International forum for
medical imaging
www.spie.org/medicalimaging.xml
February 9 – 14, 2013
Florida, USA
Intern. eHealth, telemedicine and health ICT
forum for education, networking and business
www.medetel.eu
April 10 – 12, 2013
Luxembourg, Luxembourg
European orthopaedic
design and manufacturing conference
and exhibition
www.orthoteceu.com
October 23 – 24, 2013
Zurich, Switzerland
MD&M West
Implants Lyon
International trade fair
for manufacturers of
medical devices
www.canontradeshows.
com/expo/west13
February, 12 – 14, 2013
Anaheim, USA
Intern. conference und
exibition for orthopaedic
implants and biomaterial
www.implants-event.
com/2013-uk-index.php
April 3 – 4, 2013
Lyon, France
China Med
International exhibition
for medical instruments
and equipment
www.chinamed.net.cn/en
March 28 – 30, 2013
Beijing, China
MEDTEC Europe
European medical device
manufacturing industry,
trade fair
www.medteceurope.com
February, 26 – 28, 2013
Stuttgart, Germany
MED engineering INTERNATIONAL 2013
Embedded World
International exhibition
and conference
www.embeddedworld.de/en
February, 26 – 28, 2013
Nuremberg, Germany
SMT Swiss Medical
Technologies
Meetingplace for
Medtech
www.ephj.ch/en
June 11 – 14, 2013
Geneva, Switzerland
MD&M East
International trade fair
for manufacturers of
medical devices
www.canontradeshows.
com/expo/east12/index.
html
June 18 – 20, 2013
Philadelphia, USA
AdvaMed Conference
International MedTech
conference
www.advamed2012.com
September 23 – 25, 2013
Washington, USA
10
K 2013
International trade fair
for plastics and rubber
www.k-online.de
October 16 – 23, 2013
Dusseldorf, Germany
MEDTEC China
Trade fair for Medical
device manufacturing
industry
www.medtecchina.com
September 25 – 26, 2013
Shanghai, China
World Medtech
Forum
Congress and trade fair
for manufacturers of
medical technology
www.medtech-forum.ch
September 17 – 19, 2013
Lucerne, Switzerland
© Carl Hanser Verlag, Munich
MedTech News
Partnership in OR
Integration Solutions
Maquet and Richard Wolf announced sales cooperation
Maquet and Richard Wolf have announced a non-exclusive sales cooperation on
a regional level. By joining forces, both companies will be in the unique position
to offer complete, efficient and high-quality OR integration solutions for endoscopy. Both companies have significant market share in their respective fields of
expertise. Maquet offers a full range of products for the OR from tables, lights
and ceiling supply units to intraoperative media management. Richard Wolf is
one of the world’s leading manufacturers of endoscopic equipment, providing
best-in-class integrated solutions for minimally invasive surgery in all major surgical disciplines.
» The integration of
core.control and Tegris
is an opportunity to
provide a scalable and comprehensive solution.«
Timo Haller,
Head of OR integration at Richard Wolf
You need to design
a reliable product?
Our Board-to-Board and Board-to-FPC
connector portfolio supports you with
◗ Compact size
A modern OR is a highly technified environment consisting of many complex devices that must seamlessly and transparently work together to allow the OR staff
to perform safe, high-quality surgery. Furthermore ORs are part of the larger hospital IT landscape exchanging data in and out of hospital networks such as clinic
information and picture archiving systems. Managing these devices and networks as well as dealing with environmental control and multi-modality video
and image distribution is a major challenge for the OR personnel. This announcement introduces the integration of Richard Wolf’s endoscopy tower, including
the device control solution core.control, into Maquet’s TEGRIS system for OR integration. This combined solution will improve intraoperative efficiency by
streamlining device control and overall OR management thus accelerating procedures and making them safer by allowing the OR staff to concentrate on their
primary task. According to Bastian Diebald, head of Maquet’s OR Integration Global Sales: »As a provider of OR Integration systems, we view our role in the operating room efficiency improvement by uniting video routing, recording and
transmission, data management and device control – independent of the manufacturer. This cooperation provides an opportunity for our two companies to
combine forces«. »The seamless integration of Richard Wolf’s core.control and
Maquet’s Tegris offers Richard Wolf the opportunity to provide a scalable and
comprehensive solution bearing the quality and reliability of two world class companies«, said Timo Haller, head of OR Integration at Richard Wolf.
www.maquet.com / www.richard-wolf.com
11
◗ Wide product range
◗ High contact reliability
◗ Cost-efficient subsequent processing
With a contact pitch of 0.2mm to 0.8mm
and mating heights of 0.6mm to 14mm
with various numbers of contacts, you are
sure to find the right product.
For more information, please go to
www.panasonic-electric-works.com/connectors
Panasonic Electric Works
Europe AG
4ELs&AX
info.peweu@eu.panasonic.com
www.panasonic-electric-works.com
Medical Devices Wireless Controls
In the operating theatre, medical devices with controls communicating via radio waves are increasingly common. This technology offers
considerable advantages but demands high signal reliability.
Signal Transmission
via Radio Waves
1 Hygienic, ergonomic, versatile: wireless controls in
operating theatres, doctors’ surgeries and hospitals
are advantageous for multiple reasons
W
hich features should controls for medical equipment
have? They need to be ergonomically comfortable and
intuitive to use – not always easy to realize in the light
of increasingly complex functions. They must be extremely reliable and failure-safe. In addition, their design has to meet hygiene
requirements. And they should also offer the surgeon or surgical
staff a free choice of posture while working.
With all these requirements in mind, the utilization of foot controls has proved a good choice for many medical devices and across
very different medical disciplines (Figure 1). This is by no means
MED engineering INTERNATIONAL 2013
a new development, but one which has taken place over decades.
What is new, however, is that these foot controls are increasingly
wireless. There are good reasons for this, based on the
Wireless transmission
above mentioned requirehas to be reliable
ments. A wireless foot control can be positioned far more freely than a switching device with
power and signal transmission cables, and it also adheres far more
closely to the ›Hygienic Design‹ guidelines. In addition, a cable
which could turn out to be a tripping hazard is removed from the
12
© Carl Hanser Verlag, Munich
Contact
steute Schaltgeräte
GmbH & Co KG
D-32584 Löhne/Germany
Phone +49 (0)5731 7450
Fax +49 (0)5731 745-200
All photos: steute Schaltgeräte GmbH & Co. KG
2 The modular design of steute’s wireless technology –
here the Bluetooth
module inside a foot
control – permits
simple integration in
control systems
www.steute.com
floor. Uniting foot controls and radio technology is therefore an
elegant solution for the operating theatre – but one which is not
so easy to realize. This becomes clear when one takes a look at the
demands made on signal transmission by the sensitive application field of medical equipment.
Most important of all, the system must be free from interference
and transmission has to be reliable: it must not be allowed to happen that a command given by the surgeon does not reach the device. This is all the more difficult to guarantee because in hospitals there are numerous potential sources of interference, such as
Wi-Fi networks. The crucial keyword here is coexistence ( freedom
from mutual interference with other wireless networks). This
means that the radio protocol has to check and confirm correct reception. In addition, it is a good idea to allow for redundancy (in
the shape of multiple transmission) or other safety functions in
order not only to detect a fault, but to guarantee that signal transmission will still go ahead correctly and rapidly. Further requirements for wireless communication
Wireless protocol
in the operating theatre involve,
amongst other things, connection
for worldwide use
time (as fast as possible), power
consumption (as low as possible in order to achieve a long battery life) and a wireless protocol which can be used worldwide. Last
but not least, cost (as low as possible) also plays a role.
Diverse approaches have already been pursued in the past. As
much as fifteen years ago, developers in the steute business field
Meditec had first wireless switching devices ready for the market.
One of the elements used was infra-red data transmission. However, this type of wireless signal transmission is only suitable for
devices which are not safety-related, for example imaging devices, because the infrared signals are only unidirectional and not
Company Profile
Micro-optical precision sensors!
Our patented micro-optical components comprising precision LEDs, lasers and photodiodes
and a one of a kind modular construction
system enable us to produce high-performance
opto sensors which really fit. Their small size
and their extraordinary performance make
them ideal for medical technology applications.
STM Sensor
Technologie
München GmbH
We offer various standard products and optimally adapted customer-specific solutions.
Headquarter in Germany
Prof.-Messerschmitt-Str. 1
85579 Neubiberg
Phone headquarter:
+49 89 666371-0
info@stmsensors.de
www.stmsensors.com
Our product range:
• Micro-optical LEDs, photo diodes and laser
modules
• COMPACT optical sensors for position detection
• MICROmote® - The superior alternative to
fiber optics
• Optical sensors for use in extreme environments
• Optical light band sensors for web guide control
• Fork and frame sensors for counting applications
• Precision liquid level sensors
• Customized Solutions
Applications:
• Assembly and Handling Automation
• Processing
• Medical and analytical laboratory equipment
• Measurement technology
www.stm.com
• Special machine building
Sales Office in U.S.A.
STM Sensors Inc.
P.O. Box 1888
Round Rock
TX 78618
Phone: +1 419 8410135
Fax: +1 419 7542285
sales@stmsensors.com
www.stmsensors.com
13
MED engineering INTERNATIONAL 2013
Medical Devices Wireless Controls
4 For phacoemulsification steute has developed both customized
foot controls and a control which is suitable for all manufacturers,
transmitting signals either via a cable or radio waves
Fast bidirectional
transmission
sufficiently interference-free either. LCD displays, for example, can
impair the quality of signal transmission.
When the Bluetooth standard was
introduced worldwide in the year
2000, steute enhanced it for medical equipment. And with success:
since then, numerous manufacturers of medical devices have used
steute wireless foot controls incorporating this technology (Figure 2).
Typical application fields include
ophthalmology and surgical microscopes. Some application fields
make demands which cannot be
met using Bluetooth, however. The
power consumption of wireless units and the wake up
time when activating
a control unit in
standby mode are
both problematic,
for example. For
these reasons steute
has developed its own
tried-and-tested wireless
protocol, marketed under
the name SW 2.4 MED.
The protocol is based on the globally accessible 2.4 GHz waveband.
The communication protocol is
split between 32 channels and navigates between these channels
using a ›frequency hopping‹ procedure. In this way sources of interference are avoided. In addition,
the SW 2.4 MED wireless technology has at its disposal various other
MED engineering INTERNATIONAL 2013
5 Even complex functions can be managed using the SW 2.4 MED
wireless protocol. Pictured: a new control system for surgical
microscopes
procedures for the automatic detection and correction of transmission errors. And since one transmitter and one receiver unit
are always mutually and strictly assigned via a special ›pairing‹ procedure, the user can simultaneously operate all manner of devices communicating via SW 2.4 MED.
Signals are transmitted bidirectioSleep mode
nally within 20 milliseconds. Four
reduces
power
protocols are transmitted at diffeconsumption
rent frequencies, each taking 5 ms.
This meets the requirement of a
short response time. Bidirectional transmission means that signals
are acknowledged and that errors can be detected directly. In this
case the transmitter and receiver modules automatically hop to a
different channel. The channel with interference is permanently
faded out.
At a maximum of 25 mA, the power consumption of this wireless
communication is as much as 60 percent lower than
with other radio standards. The steute engineers
have also managed to achieve a further
energy-saving effect. Since medical
devices are seldom in operation
for hours on end, most of the
power is usually consumed during periods of inac-
3 With handheld controls, the
very low power consumption of the SW 2.4
MED radio standard proves
especially advantageous. It creates the prerequisite for using a small
and light battery while achieving a long
battery life
14
© Carl Hanser Verlag, Munich
MG110025
www.med-eng.de
tivity, in which only stand-by signals are sent and the device waits
to be actuated. This is inefficient. The sleep mode was therefore
developed as an energy-saving function during such waiting periods. In this mode the wireless system reduces its power requirement to just 6 μA. As soon as the
Wireless control
user activates a switching function,
the system is reactivated and the
of a surgical
wireless data connection restored
mircroscope
in under 200 msec. This usually
goes unnoticed by the user, who nevertheless profits from a considerably longer battery life. Due to the low power consumption,
a very long battery life can be achieved with alkaline batteries. A
further option is a lithium-ion battery pack which can be recharged
using a battery charger. This rechargeable unit contains a battery
management feature which continually records, monitors and
transmits the key parameters such as battery voltage, remaining
capacity, temperature and the number of charge cycles.
Microelectronics and the availability of modern sensor technology
have enabled interesting extra functions to be realized, further increasing the reliability of this wireless technology. One example:
sensors permanently monitor the position of the foot control. If
the control unit is lifted off the floor, all functions are automatically blocked and a warning signal is generated.
Since steute Meditec has designed its wireless technology as a compact and modular system, with nearly all foot controls in the stan-
@
dard catalogue range the user has the choice between a system
with a cable or a wireless system. That is true not only for the foot
controls, but also for the new generation of hand controls
(Figure 3). Thanks to the low power requirement of the SW 2.4
MED radio technology, a long battery life can be achieved with a
small and light battery. This also increases the user’s comfort, especially with the hand-held devices.
Our foot control for phacoemulsification demonstrates how even
very complex functions, including analogue signals, can be managed by SW 2.4 MED (Figure 4). For this form of eye surgery to
treat cataracts, steute has developed a foot control for ophthalmologists incorporating a mobile foot rest. Moving the foot guides the breakdown and extraction of the human eye lens. Additional push-buttons regulate or activate extra functions, such as
the intensity of the cutting tool or the rinsing of the eye. steute
has also developed a complex control for a surgical microscope
which transmits signals using radio technology (Figure 5).
Guido Becker
is Product Manager Meditec at steute Schaltgeräte in Löhne,
Germany.
meditec@steute.com
Company Profile
apra-plast
KunststoffgehäuseSysteme GmbH
Germany
Hamsterweg 9
54550 Daun-Pützborn
Tel. +49 6592 9502-0
Fax +49 6592 9502-10
vertrieb@apra-plast.de
www.appra-plast.de
The apra-plast Kunststoffgehäuse-Systeme
GmbH is a specialist for the production of individual plastic parts and enclosures for low and
middle quantities (1 – approx. 2000 pieces). The
combination of milling and bending enables
apra-plast to offer customized enclosures and
complex solutions. In cooperation with the apranorm department radaplast, that also belongs to
apra group, there can be realized quantities up
to 100.000 pieces in our in-house tool making
and injection moulding from the first drawing or
model to the whole series.
radiuses in a solid design and with optical correctness. This technique brings many advantages
compared to usual milling / bending technique
such as better quality and cost-effective production of small batches as well as prototypes.
The new circular bending technique enables
apra-plast for the first time to realize also small
Another big advantage is the material mix in the
apra group: electronic enclosures that can be
produced in combination of the different materials sheet steel, stainless steel, aluminium and
plastics.
The apra group uses all advantages of the different materials and manufacturing techniques in
an optimal way.
True to our guideline apra produces “the perfect
shell for valuable electronics” for more than 40
www.apra-plast.de
years.
15
Furthermore there are almost no limits in customer´s requirements regarding design: In addition to different material colours and thicknesses
the enclosures can be customized also by using
silk screen, front foils, membrane keypads or
integrated LED.
MED engineering INTERNATIONAL 2013
Medical Devices Sensor Systems
Modern sensors and measurement systems are helping to make medical interventions more secure, automate research, and to design
more ergonomic medical devices.
Sensors in
Medical Technology
housing
guard ring
capacitor
field lines
measuring spot
L
et's start with capacitive displacement sensors. During capacitive measurements, the
sensor and target act as electrodes
for the electrical capacitor (Figure 1).
If a constant alternating current is
flowing through, the amplitude of
the alternating voltage is proportional to the distance between sensor
and target. Capacitive sensors are
very stable and provide nanome-
MED engineering INTERNATIONAL 2013
ter-accuracies and resolution, which is why these sensors are used
in high precision applications. For example, they are used in surgical procedures, where a perfect line of vision to the operating
table is required. Here, the surgeon is often supported by a surgiFine positioning
cal microscope. The microscope
optics are attached to the long arms of a stand. The pivot joints require continuous adjustments to keep the microscope area of vision stable for the surgeon. This is where the capaNCDT capacitive sensor is used. The system measures the distance to the reference area, which reflects the arm movement in the pivot joint. If
16
© Carl Hanser Verlag, Munich
All photos and figures : MICRO-EPSILON MESSTECHNIK GmbH & Co. KG
1 Measuring principle of
capacitive sensors: If a constant alternating current is
flowing through, the amplitude of the alternating voltage is proportional to the
distance between sensor
and target
MD110023
www.med-eng.de
@
2 Confocal chromatic sensor scanning the fill level of microtiters
the reference
displacement is too large,
the control mechanism will move
the arm back to its original position. Key benefits of this solution include its compact design and easy integration of the system into an existing design. It also provides the surgeon with a clear picture throughout the entire procedure.
even if the meniscus of a liquid is large. confocalDT sensors can be used for measurements on any
liquid. Miniature sensors with a diameter of four millimeters or
more can be arranged in rows to scan the entire width of the microtiter plate.
wireSENSOR draw-wire sensors ensure optimum patient positioning of operating tables. The sensor wire is wound around the
drum (Figure 3) on one side and attached to the moving object on
the other side. An encoder translates the movement created by
the extension of the wire into an electronic signal. An operating
table is modular in design and provides many adjustment options for the
optimum positioning of the patient
during an operation: table height,
horizontal position and multiple angle
features, e.g. for head, torso and legs.
Measuring technology is required to
read the positions of the various
adjustable elements. Due to their
compact footprint, high precision and
long service life, draw-wire sensors
from Micro-Epsilon are the ideal
choice. Typically, up to five draw-wire
sensors are mounted to an operating
table. As well as standard sensors with
steel wires, there is also a choice of
synthetic wire versions or sensors with
plastic connectors that prevent any
3 Internal structure of a draw-wire sensor:
Beside sensors with steel wires, there is also a
interference with X-ray or MRI scans.
In certain cases, sensors even make it possible
to switch from manual to automated procedures, for example, in medical laboratories. In
this scenario active agents are manually filled
into microtiter containers for batch testing. It
is essential, but
also challenging,
Filling level
to measure each
measurement
agent precisely.
During automated filling, the fill volume is controlled automatically. However, small batches
that are often used in medicine are pipetted
manually. Typically, random samples are measured, but this is not sufficient for 100 percent
quality control. Confocal displacement measurement is an excellent solution for such
applications. During confocal chromatic measurements lenses are used to separate white
choice of synthetic wire versions or sensors
light into different spectra, which is then fowith plastic connectors that prevent any interIn addition to draw-wire sensors,
cused perpendicular to the object (Figure 2).
ference with X-ray or MRI scans
capacitive and confocal measuring
A spectrometer is used to transmit the resystems for displacement and disflected light to the CCD array: each position in
tance measurements, Micro-Epsilon offers optical micrometers,
the CCD array now corresponds to one wavelength, i.e. the distemperature and colour sensors, laser sensors, and magneto-intance between target and sensor. This technology facilitates meaductive measurement systems for medical technology, pharmasurements to nanometer
ceuticals and biotech industries.
resolutions. The confocalDT
sensors
successively
scan
Contact
the microtiters in the plate,
MICRO-EPSILON MESSTECHNIK
and the system measures
GmbH & Co. KG
the distance from sensor to
D-94496 Ortenburg/Germany
liquid to micrometer accuPhone +49 (0)8542 168-471
Dipl.-Phys. Johann Salzberger
racies. Standard confocal
is Managing Director Marketing and Sales at
Fax +49 (0)8542 168-90
sensors can be tilted which
Micro-Epsilon Messtechnik in Ortenburg, Germany.
www.micro-epsilon.de
Johann.Salzberger@micro-epsilon.de
means they work reliably
17
MED engineering INTERNATIONAL 2013
New Products
Multiturn
Encoder
The SHTC1 humidity and temperature sensor is specifically designed
for mobile devices where size is always a critical factor. During the development of the high performance humidity and temperature sensor, Sensirion has rigorously followed the maxim ›smaller is better‹. According to the
company, it is world’s smallest sensor in its class, measuring 2 x 2 x 0.8 mm.
The sensor is based on the CMOSens Technology, which allows the sensor
and the signal processing electronics to be combined on a single silicon chip.
This reduces the size of the device. Production is targeted at high volume to
Small Sensors are Better
allow low unit prices to be achieved by economy of scale. The supply voltage
of 1.8 V is in line with the designers’ needs. The specifications of the new sensor show that the size, power consumption and price reductions do not have
any impact on performance. It measures relative humidity over a range of
0 to 100 percent RH with a typical accuracy of ±3 percent RH. The temperature measuring range is –30 to +100 °C with a typical accuracy of ± 0.3 °C.
The sensor is calibrated, has a digital I2C interface, and is suitable for reflow
soldering. This makes it compatible with standard industrial mass production
processes for electronic modules. To ensure effective integration of the sensor in complex applications. Sensirion draws on its long experience with sensor products deployed in the millions and supports customers with corresponding application expertise.
www.sensirion.com
Gear and battery free operation.
PEWATRON distributes ELTRA’s
multiturn encoder EAM36 with SSI
interface. Wherever drives need
compact and cost effective feedback systems, or in applications demanding particularly compact size,
or customer specific applications
fields, the EAM36 series with a size
of only 36 mm of OD and 43 mm
of length represents an excellent
choice. It is robust, provides a high resolution of 51 bit in total, high reliability and a gear and battery free operation. What makes the EAM36 encoder
series special is the unique technology used to count the number of rotations that the device does. The solution that the Eltra designers developed
is based on the ›Wiegand effect‹. The
key feature of the EAM 36multi-turn
encoders is that the turn counter
mechanism is self-powered. The encoder shaft rotation generates enough
electrical energy – independently
from the
rotating speed – to trigger the turn
counter and to save the event in a
non-volatile random-access memory
(FeRAM). Eliminating the traditional
mechanical gear or electronic counter with battery ensures a higher reliability and a maintenance free solution. The magnetic technology is the
key contributor for ruggedness and
compact size of the EAM36 complementing the well known ELTRA's multi-turn optical series (EAM58, EAM63).
www.pewatron.com
with a detachable cord that is
compatible with nearly any voltage, frequency and plug type
worldwide. Their mounting
plate-backward compatibility
with SKF Telescopic pillars series
TXG, cable-through with inlet
and outlet mains socket accessories and low 1 W standby
power expand product design
and differentiation possibilities.
The products come with a variety of choices: selection of the position of the outer tube, motor,
connector, and power in. These
choices offer the customer a tailor-made solution to improve
both operator accessibility and
patient comfort. The telescopic
pillars are available from different SKF manufacturing facilities
worldwide providing support to
OEM’s regardless their market
location.
www.skf.com
Telescopic Pillars
Solutions for ophtalmology and infant care
SKF announces the telescopic
pillars for ophthalmic equipment
and infant care series CPMA and
CPMB. It is a lifting solution for a
range of medical equipment like
ophthalmic chairs, ophthalmic
tables and incubators that provides higher flexibility for the integration into OEM’s design. The
CPMA series that consists of telescopic pillar for ophthalmic
equipment and the CPMB Telescopic pillar for infant care offer a
complete IEC/UL 60601.1 3rd
edition compliant solution. Features include a soft start/stop
motion that allows silent lifting,
a short retracted length and increased stroke length for greater
MED engineering INTERNATIONAL 2013
accessibility as well as
a wide degree of design flexibility overall.
The reduction of noise
and vibration provide
greater comfort for
both patients and operators. Both pillars are
compact, two-section
units with the ability to
mix and match several
performance features,
such as allowing variable placement of the
motor and inner and outer
tubes. They also offer a loadcarrying capacity of up to 2000 N
and up to 250 Nm as well as a
built-in universal power supply
18
© Carl Hanser Verlag, Munich
Intelligent Actuator
No control box necessary
Limited space can turn the integration of electrical adjustment
systems into medical applications a considerable challenge.
With two new linear actuators,
LA43 IC (8,000 N) and LA44 IC
(10,000 N or 12,000 N), LINAK
offers an answer. The IC actuators are based on the OpenBus
platform and with a printed cir-
The Precision Fluidics Division of Parker Hannifin
is introducing the PACE Hf high flow miniature
proportional valve targeted at respiratory and anesthesia applications. It utilizes a piezo actuator to enable controllable flow of up to 540 slpm in a very compact and
Miniature
Control Valve
energy efficient package. The valve can control flow from 0,5 to 540 slpm with
a 0 to 10 V DC analog input controllable in 0,001 V DC increments. This enables precise flow control throughout the full performance range of the valve.
The proportional valve has an integrated sensor port that facilitates simple,
closed loop feedback giving the customer precise pressure or flow control. Typical applications will consume less than 1 W, enabling longer battery life or
the ability to use a smaller battery to save size and weight. The typical hysteresis amounts to < 4 percent (full scale) an the response time to less than
20 msec (full cycle).
www.parker.com
cuit board inside there is no
need for mounting a control
box. High speed under maximum load and a low noise level
offer a high degree of comfort.
The actuators can be connected
directly to a foot switch or hand
control and a second linear actuator. If necessary power is supplied by the SMPS30, a switch
mode power supply with an input-range from 100 to 240 V AC.
The 300 W powerful SMPS ensures maximum use of actuator
capacity and is an eco-friendly
solution due to a low standby
power consumption compared
to traditional transformer solutions. The exchangeable mains
and output cables make it easy
to exchange cables due to wear
and tear and ensure a safe application and worldwide compa-
www.cim-med.com
Simply lighter
CIM med’s cable integrated mounting solutions and unique
medical carrier systems for modern clinical operations.
We carry your concepts farther
tibility. The new product family
is completed by the addition of
the FS3 foot switch which is simple and intuitive to operate and,
in addition to the floor model, a
model for direct mounting on
the side of a bed frame will be
released shortly. If it is necessary to have a foot switch for control of more than one movement, the modular construction of the FS3 allows it to be extended according to the needs.
Products based on LINAK’s
OpenBus technology, allow to
attach accessories, such as:USB
hub, reading lamp or an infrared hand control, thereby
broadening the range of uses.
Thanks to OpenBus, the service
data are recorded in the actuators and can be easily read out.
www.linak.de
Laboratory Devices Piezoelectric Drives
Neither magnetic fields, humidity or vacuum influence the performance of piezoelectric drives. In laboratory automation, especially
the drives that can be easily integrated are of great advantage.
Small, Fast, and Precise
L
aboratory automation is a very special field of automation
engineering. It is concerned with the automation of laboratory processes in chemistry, bio-engineering, pharmaceutical and food technology as well as medicine aiming to improve
the reproducibility of the processes and save time and costs
through automation. Undoubtedly quite different from each
other, the various markets have one crucial thing in common: they
need fast and precise drive systems. If the application so requires,
they must also be as compact as possible or operate reliably even
in strong magnetic fields, at low temperatures and in a vacuum.
Piezoelectric drives, scanners and positioning systems are a safe
bet here, ranging from
pumping and dosing tasks
through sample manipuContact
lation to fully-automatic
screening.
Physik Instrumente
GmbH & Co. KG
The precise supply of sub76228 Karlsruhe/Palmbach
stances is one important
Germany
field of laboratory automaPhone +49 (0)721 48460
tion. The compact dimenFax +49 (0)721 4846-1019
sions, high precision and
www.pi.ws
dynamics of piezoelectric
MED engineering INTERNATIONAL 2013
drives combined with their low purchasing and maintenance costs
make them indispensable for micropumps and nanoliter dosing.
The same applies to piezoceramic
disks for generating fast oscillations
Precise pumping
as well as for actuators with strong
and dosing
acceleration at strokes of 10 to
1000 μm, and piezomotors for fast motions in the range of several
millimeters. Physik Instrumente offers a comprehensive product
portfolio for these applications.
Micro-diaphragm pumps are a typical exemplary application of piezoceramic actuators. They work in a similar way to piston pumps
but the medium to be transported is separated from the drive by
a diaphragm (Figure 1). The drive can therefore not interfere with
the pumped media and vice versa. Highly dynamic, disk-shaped,
piezo elements mounted directly onto a metal disk lend themselves to the miniaturized version of this type of pump. High delivery
rates can thus be realized even under backpressure by varying the
switching frequencies or the amplitude of the piezo displacement
by means of a corresponding control.
Micro-dosing valves operate in a similar way to pumps but the forces required are higher. The common dosing frequencies in this
application are usually in the kilohertz range and can be imple-
20
© Carl Hanser Verlag, Munich
Photos 1 and 3: Physik Instrumente
3 The lamellae are
readjusted individually
by compact drives in
order to predetermine a
certain shape and eliminate undesired peripheral effects of the illumination and/or radiation
>>> f a s t f o r w a r d s o l u t i o n s
1 The precise supply of substances, e.g. by micro-diaphragm pumps, is one important field of laboratory automation. The "driving force" is
a disc-shaped piezoceramic
5
ISO 1348
Certified
mented only with piezo actuators. A variety of piezo components
are used in the micro-dosing valves, depending on their size. For
example, small piezo tubes are used for drop-on-demand methods, like in ink jet printers. Miniaturized valves for dosing tasks
in the nanoliter range are produced using piezo disks, for example, which are also used for lab-on-a-chip applications. Valves requiring larger strokes can be implemented by piezo actuators with
a lever system. They are suitable for longer travel and thus also for
applications in which certain drop sizes have to be achieved as a
function of the material properties.
Of particular interest in this context is the piezo-driven direct displacement method used in PipeJet dispensers (Figure 2) which
differs from most of the common piezo dosing methods in two
crucial ways: The fluid line does
Proper system for not consist of glass or steel capillaries, but is made from an elastic
positioning tasks
polymer tube that has a defined
internal diameter and is not permanently attached to the piezo
actuator. This means that any parts contaminated by fluid can be
easily and cheaply replaced.
Automation in laboratory environments is often necessary because ambient conditions restrict the accessibility, e.g. in vacuum,
magnetic fields, radiation or because components are integrated
deeply into the system. Small, precise, and reliable piezo drives
are the proper solution for this task. Typical applications include
multi-leaf collimator apertures, in which small lamellae are readjusted individually by compact drives in order to predetermine
a certain shape and eliminate undesired peripheral effects of the
illumination and/or radiation (Figure 3).
Similar requirements apply to sample manipulation or alignment
of optical imaging systems by miniature drives. For this purpose,
PI offers a large selection of appropriate positioning and handling
systems based on different piezoelectric working principles: for
example ultrasonic piezo drives are well-suited for many applications requiring high dynamics (Figure 4). Working as direct drives,
they dispense with the mechanical components of classic motor
spindle-based drive systems such as clutch or gearhead to the benefit of costs and reliability. They are lightweight and suitable for
travel speeds up to approximately 500 mm/s, their accuracy is in
the range of approximately 50 nm. Since they are offered in various steps of integration, they are easy to adapt to the application on hand.
21
Customized drive solutions
3 Near Patient Device
3 Electronically Enabled Drug Delivery
(EEDD)
3 Infusion and Medication
3 Ambient Assisted Living
www.buehlermotor.de
We look forward to
seeing you at:
Pharmapack Europe
in Paris
Grande Halle de la
Villette, Booth 475
13. – 14. Feb. 2013
Medtec Europe
in Stuttgart
Hall 3, Booth 3G49
26. – 28. Feb. 2013
Bühler Motor GmbH
Postfach 450155
90212 Nuremberg
Germany
Tel.: +49(0)911 / 45 04 - 0
Fax: +49(0)911 / 45 46 26
info@buehlermotor.de
Laboratory Devices Piezoelectric Drives
The PIFOC Z drives (Figure 6) for the objective lens can be designed to be very small and
stiff. This allows them to respond with short
slow
fast
release
displacement
response times and position very precisely
active
due to the good guiding, even with relativepiston
area
ly long travel ranges. Furthermore, motionby
by actuator
actuator
related disturbance of the sample can be ruoutlet
led. Designed accordingly, the PIFOC Z drives
Io
channel
can move individual objectives or the entire
revolving nosepiece depending on the appliorifice
cation. However, there are also reasons for
moving the sample instead of the objective
during focusing, e.g. when the optical path
jet
ejection
is not supposed to be changed or the structu© MED engineering INTERNATIONAL
re of the microscope makes this a good idea,
e.g. with inverted microscopes. In this case,
2 The PipeJet technology uses piezo-driven direct displacement for dosing
scanning piezo stages whose aperture can
accommodate either the sample holder or
microtiter plates are then practical.
In
microscopic
studies
involving long exposures or where the samPiezo-based inertia drives are considered to be particularly comple behavior needs to be observed for extended periods of time,
pact and inexpensive micro-drives. They utilize the stick-slip
it is important to stay exactly at the same position and/or the comeffect for fine steps with step heights of less than a micrometer.
pensate for any drift in the direction of the z axis. A typical examA piezoelectric actuator expands and takes along a mobile rod. In
ple is the investigation of dynamic processes in living cells. In this
the second part of the motion cycle, the actuator contracts so raapplication, it is most important that the drives that are used can
pidly that it slides along the moved part, which cannot follow this
tolerate the moist and warm conditions in the incubator and that
motion due to its inertia, and thus remains in the same position.
these systems integrate well into the feedback systems.
The electric control is easy and simiFocusing on the
Piezo drives thus have an advantage even with such focus stabililar to a saw-tooth voltage. The
zation applications with drift tracking: moisture does not impair
drives
are
small,
which
opens
up
object’s surface
the functioning of the PICMA actuators used, and the digital conmany application areas. Typical aptrollers can be integrated well in the higher-level
plications for this drive principle range from soldering tip positiosystems. They make it possible to switch between
ning to shutter adjustments in micromanipulation. High forces
an internal sensor in the drive and an external
and a high resolution are achieved when piezoelectric
one. For example, a signal that is proportioinertia drives are used to move screws, which allows the automation of alignment tasks in
inaccessible places. Depending on the design, they are operated at a frequency of
4 PILine ultrasonic direct drives
20 kHz, which means that they cannot be
are lightweight and suitable
heard, and reach velocities of up to
for travel speeds up
to approx. 500 mm/s and
10 mm/s (Figure 5).
accelerations of up to 20 g.
The autofocus function is one of the tySince they are offered in
pical applications of piezo drives in mivarious steps of integration,
they are easy to adapt to the
croscopy, i.e. the focusing on the desired
application on hand
object plane or surface of the sample. In order to guarantee the quality during analysis,
the focus needs to be readjusted for each samnal to the distance between objective lens
ple with the shortest step-and-settle times possiand sample can be used as external sensor signal
ble. This task is assumed by the piezo drive. The
(actual value). If the distance between objective lens and samspeed requirements of autofocus applications are
ple is set so that the desired structure of the sample is sharply dehigh where high throughput is essential. Moreover, the
fined, the corresponding sensor value can be fed to the piezo conradiation of fluorescent tracers can have toxic effects on the cells
troller as a target value. If the distance between sample and obwhich is yet another reason why the time factor is so crucial in fojective lens then changes due to drift processes – which shifts the
cussing. Whether the piezo drive moves the objective lens, the
plane of focus in the sample –the piezo controller adjusts the volobjective nosepiece or the sample along the optical axis in autotage on the piezo drive until it changes position enough to comfocus applications depends on the application on hand.
MED engineering INTERNATIONAL 2013
Ii
22
© Carl Hanser Verlag, Munich
Figure 2: Source Biofluidix; Photos 4 to 6: Physik Instrumente
inlet
channel
MG110017
www.med-eng.de
@
6 PIFOC Z drives cannot
only be used to adjust
individual objective lenses,
but the entire objective
nosepiece as well
5 Bar drive with piezoelectric stick-slip drive for
speeds of up to 10 mm/s
pensate for the drift. This keeps selected sample structures in focus to extended periods of time. The same system can therefore
be used for drift compensation in the Z direction as well as for fast
Z scans. Whether the piezo drive is integrated in the objective lens
holder or the stage is again determined by the application.
The piezo drives operating with vertical travel between 0,1 and
0,5 mm can often be directly integrated in the existing XY sample
scanner (Figure 4) due to their compact design. This means that
all common sample holders for object slides up to microtiter
plates can still be used. The low total height of the full XYZ system
allows for the use under all common microscopes and integration
and control are as simple as with a classical XY stage.
XY stages as used in microscopes, for example, for the positioning
of samples during scans, should be as flat as possible to make them
easy to integrate and allow easy access to samples or, in the case
of inverted microscopes, permit the revolving nosepiece and
other elements below the stage to be reached. Flexibility with regard to velocity and reMicroscope stage with
solution is also essential
ultrasonic piezomotors to be able to use microscopes for different
tasks. Microscope stages operating with ultrasonic piezo drives
meet all pertinent requirements in optimal manner. As linear direct drives, the compact piezomotors render lead screw ducts and
flanged-on stepping motors dispensable. In addition, they are selflocking at rest and thus hold the stage in a stable position. With an
overall height of just 30 mm, they are extremely flat and suitable
for travel between 85 and 135 mm. The large aperture accommodates holders for Petri dishes, standard object slides or microtiter
plates.
The ultrasonic piezo drives used in this application allow for constant speed over a wide range from 10 μm/s to 100 mm/s. The
stage can thus be used for direct visual observation at high magnification (objective lens 100x at approximately 10 μm/s) without
"jerking" disturbing and tiring the user on the ocular lens or monitor while controlling the XY stage with the directly connectable
USB joystick. The user will also appreciate how quietly the stage
works. The same microscope stage is equally well suited for automated scanning applications that require high speeds of up to
100 mm/s and short settling times. In combination with a linear
encoder, position resolution is 0,1 μm, and the bidirectional repea-
23
tability is 0,4 μm. As a result, so-called points of interest can be reliably found again and precisely approached. This is also advantageous in high content screening
analysis technology, when large
numbers of samples (e.g. tissue
samples) are to be scanned. In addition to short settling times, the
good repeatability is important
here for "tiling" the images. This large number of application options
demonstrates that laboratory automation without piezo-based drive
solutions is hardly conceivable any
longer.
Easy operation even of complex motion sequences and simultaneous
easy integration in the control software of the user are important requirements for modern motion controllers. Especially in laboratory
automation, an additional requirement is the compatibility with common software packages from thirdparty suppliers such as, Lab View,
Manager or MetaMorph. Controllers
made by PI meet these requirements, e.g. by the PIMikroMove user
interface, driver components that
are compatible across different systems and a uniform command
language, the General Command Set
(GCS). All necessary components for
PI controllers are included in the
standard scope of delivery.
Focus
stabilization
Dipl.-Phys. Steffen Arnold
is Head of Marketing and Products at
Physik Instrumente (PI) in Karlsruhe, Germany.
s.arnold@pi.ws
MED engineering INTERNATIONAL 2013
Laboratory Devices Rapid Manufacturing
Germany-based Zellwerk is using single-use bioreactors. The rapid injection moulded parts are made from special plastic resin with carefully controlled surface finish properties and open up completely new
perspectives in the world of regenerative medicine.
1 The system is made up of
a hatchery (left) and a measurement and control module. In the hatchery you
can see the core part: the
single-use bioreactor in
which the cells grow
W
hen it comes to the war
on cancer, the body has
its own front guard: Natural killer cells are able to destroy
their cancer cell rivals and prevent
viral infections from spreading. Unfortunately, the immune system in
many patients is already weakened
to such an extent that it cannot produce enough of these precious
cells. Now however, the German
company Zellwerk has succeeded
in cultivating cells outside the human body in greater quantities than
ever previously achieved.
MED engineering INTERNATIONAL 2013
Zellwerk, a specialist in cell culture and
tissue engineering, performs the task
using single-use bioreactors manufactured using injection moulded components. Prof. Dr. Hans Hoffmeister,
CEO of Zellwerk, describes the system
while holding an inconspicuous, transparent plastic part with a lid in his
hands. »Our bioreactor meets all the requirements necessary to produce the
body's own cells in the same quantity
as drugs, in a standardized and repeatable process«, he says. »The patented
system is both a revelation in regenerative medicine and the dream of biomedical scientists. It takes a sample
from the patient such as blood, isolates
the immune cells, cultures them outside the body in large quantities, and
leads them back to fight tumour cells.«
The Zell system is called ›Z RP Technology‹ and comprises an incubator, located in the sterile work chamber of the
bioreactor, and a special adapter (Figure 1). An external control
unit monitors, controls and documents all of the parameters. »It
is critical that laminar flow is created in the plastic reactor«, explaines Hoffmeister. »The cells are placed on the bottom of the reactor and flushed evenly without creating turbulence. Simultaneously, cells with oxygen and fresh medium are supplied, while
spent media is transported and a constant pH maintained.« To ensure the repeatability of the process, the vital element of the challenge was to create a special surface in the reactor offering the optimum amount of friction – not too smooth and not too rough.
Construction Manager Rainer Mausolf summarizes the requirements for the reactor resin and its surface condition: »The choice
of plastic was crucial because we needed to provide constant chemical and physical conditions in the reactor. We tried several com-
24
© Carl Hanser Verlag, Munich
All figures and photos: Proto Labs
Finished Parts
Within Ten Days
» We rely on parts of real material.
Substitute materials, offered
by traditional prototype methodes,
are useless to us.«
Prof. Dr. Hans Hofmeister, CEO of Zellwerk, Germany
mon plastics but had difficulty in finding a material
that was resistant to sterilization by gamma-rays.
Finally, with the help of
Proto Labs, we found the
optimum resin for our system«, he says. »Proto Labs
also helped extensively
with the implementation of
our surface requirements.
In Z RP Technology systems
the cells must not be free
to be rinsed around and
therefore require a finely
grained surface on which
2 left: the data of the MP50 version was uploaded directly from the 3D-CAD SolidWorks Software into the
Protomold quoting system. Within a short period of time the quote and the parts were delivered. Right: the
they find support. Only this
sensor stick
makes it possible to have a
standard, repeatable protation. Within days we received the first reactors and adapters
cess. To keep the conditions uniform throughout the system we
made using our special plastic.«
have a probe upstream of the reactor adapter that continuously
Hoffmeister indicates: »For Zellwerk this is both the most ideal and
measures the pH, temperature and oxygen, and relays this data to
least expensive solution. We absolutely rely on parts made of ›real‹
an external control unit.«
material. Substitute materials, such as offered by traditional protoAll the bioreactors and probe adapters (in different versions) used
type methods are useless for us. Within Z RP Technology are manufactured using the Protomold rapid
out Proto Labs, we would have never Order by
injection-moulded parts service. »At first we could not believe the
made as quickly and inexpensively a uploading the
speed and reliability of the service«, says Mausolf. »We knew of no
fully functional bioreactor for growth 3D model
other suppliers who could
of the body's own immune cells that
deliver finished parts within
meets the stringent requirements of
ten
days
of
transferring
the
Contact
regulatory agencies.« According to Zellwerk, the Z RP Technology
3D model. Sometimes we
ProtoLabs Ltd.
bioreactors now represent the most advanced cultivation technowould even receive compoD-74821 Mosbach/Germany
logy commercially available for adherent cell types and tissue enginents within five days, if we
Phone +49 (0)6261 6436947
neering purposes.
had
opted
for
this.
Fax +49 (0)6261 6436948
The
process
was
simple:
I
www.protolabs.de
just uploaded my 3D SolidZellwerk GmbH
Works model (Figure 2) to
D-16727 Oberkrämer
the Protomold website. AlOT Eichstädt/Germany
most immediately my
Phone +49 (0)3304 382680
Thomas Löffler
quote arrived and shortly
Fax +49 (0)3304 38268-90
is at M.A.T.C.H. Sales Marketing
www.zellwerk.biz
after I was contacted with
in Balingen, Germany.
MG110021
www.med-eng.de
thomas.loeffler@match-bl.de
valuable tips on implemen-
@
25
MED engineering INTERNATIONAL 2013
New Products
Micro Disc
Pump
Piezoelectric
pressure generation.
TTP has invented a
miniature gas pump
that replaces traditional mechanical
operation with ultrasonic
pressure generation technology in order to reduce size and provide silent
running. The micro disc pump has already been commerzialised in a
wound therapy application and is
suited to other portable medical applications such as blood pressure measurement, as well as micro-fluidic and
industrial applications where size,
noise and controllability are important
design factors. Disc Pump’s ultra-slim
design is achieved by using a piezoelectric actuator to drive pressure oscillations in a thin disc shaped cavity: one
current model measures just 4 mm in
thickness. Silent operation is achieved
by running the pump at frequencies
above the limit of hearing, using special custom, high-speed valves to rectify the pressure oscillations. According
ot TTP, the combination of pressure
generation technology and high frequency operation make it possible to
deliver pneumatic performance significantly higher than traditional pumps of
comparable size. With a wide dynamic
range, the technology has already
achieved stall pressures in excess of
600 mbar and flow rates of more than
2500 cc/min. The high-frequency
piezoelectric mechanism provides virtually ripple-free output compared to
the pulsed output that characterises
most conventional pumps. »We see a
trend towards miniaturization, portability and discrete operation in markets
such as medical devices, diagnostics and
electronics driving demand for small, silent, high-performance pumps«, says
James McCrone head of the group at
TTP responsible for micro-devices.
www.ttp.com/
technology/microdevices/pumps
Electronic Assembly announced its EA DIP203-4 LCD module at electronica in Munich. It is made for applications that require exceptionally good readability. The module features a high-contrast, alphanumeric LCD
supertwist display for four rows of text at 20 characters per row. Standard LED
background illumination makes the text even more legible. Users can choose
from black text on a yellow/green background, white text on a blue background,
and black text on a white background. An automatic temperature compensation facility eliminates the need to adjust the contrast. The display is driven by
Dot-Matrix Display
a built-in controller of type SSD1803, which is 90 percent compatible with the
HD44780 controller. The character set that ships with the display supports 240
letters, numbers, and symbols; users can also define eight characters of their
own. The controller receives its control commands via a SPI interface. A four
and 8 bit databus interface is also available.
www.lcd-module.de
Quad Lock Connector
Enhances diagnostic functionality
ITT Cannon has released a Zero
Insertion Force (ZIF) Quad Lock
Connector (QLC) for use in medical imaging and diagnostic
equipment. Reducing the spacing from the standard DL line
to 0.8 mm makes it according
to ITT up to 65 percent smaller
than existing DL products and
competitive QLC products. This
allows a reduction in the overall size of diagnostic equipment. The high pin count of
260 positions offers multiple
channel options and makes improvements to image resolution possible at the design
stage, which will ultimately re-
MED engineering INTERNATIONAL 2013
sult in enhanced diagnostic
functionality. The ZIF QLC connector system exceeds 20 000
mating cycles. Utilizing two 130
pin PCB surface mount connectors makes it more flexible in
customer PCB designs. The
component incorporates an extended insulator to secure the
four locking pins and more than
double the connection retention force. This provides a very
strong connection over the
whole life of the system. The insulators are packaged for easy
PCB installation, which decreases assembly time by over 15
percent. The connector has a
strong zinc die-cast outer body
and grounding springs which
protect the equipment against
radiated EMI/RFI interference.
Latching is both audible and
tactile and is supplemented
with two integrated cams and
four innovative locking hooks
to ensure positive mating and
prevent inadvertent disconnection by the operator. The connector is fully intermateable
with competitive products, so
customers can upgrade exis-
26
ting designs with the ZIF QLC.
When upgrading to the QLC, legacy products remain fully
functional in the transition period. Typical medical applications include ultrasound scanners, where the connector is
used to send data from the ultrasound probe to the base device and other medical equipment where it feeds data from
swappable probes to the connected base device.
www.ittcannon.com
© Carl Hanser Verlag, Munich
Einzigartig in der Vielfalt
Unique in diversity
Wir produzieren hochpräzise feinmechanische CNC-Drehteile, -Frästeile und drahterodierte Teile für die unterschiedlichsten
Bereiche der Medizintechnik, Sensorik,
Mess- und Regeltechnik.
High-end Graphics
Performance
Send and receive data simultaneously
congatec offers COM Express boards
with 3rd generation Intel Core. Offering a choice of three versions, the
company now provides maximum
graphics and processing power for
both Type 2 and Type 6 pin-out. The
key innovations of the 3rd generation Intel Core processors include 3D
tri-gate transistor design, 22 nm production and a more tightly integrated
graphics core. Featuring up to 16 GB
of dual-channel DDR3 memory
(1600 MHz) the modules provide
greater security thanks to Intel VT (Intel Virtualization Technology) and optional Intel AMT (Intel Active Management Technology) 8.0 support. The
conga-TS77 module variant is based
on the Type 6 Pin-out for new designs
and supports four native USB 3.0
ports. Benefits include faster data
transfer, lower power consumption
and the possibility to send and receive data simultaneously. Three
combined independent Digital Display Interfaces (DDI) provide SDVO,
HDMI or DisplayPort, while direct PCI
Express x16 lanes (PEG 3.0), LVDS and
VGA are available as separate graphic
interfaces. For existing project designs, the company now offers two
module variants for Type 2 Pin-out on
COM Express for maximum graphics
performance. In accordance with the
COM Express specification, the congaBP77 module features PCI Express x16
lanes (PEG 3.0), LVDS and VGA graphic
interfaces. This module is suitable for
applications that are based on PEG
graphics and require an external highend graphics performance. PEG is implemented via a custom carrier board.
The schematics of the evaluation
carrier board conga-CEVAL, which are
available for free download, provide
a template for the development of
the application specific carrier board.
For existing project designs on Type
2 Pin-out requiring a maximum of
flexibility with regard to the graphics
interfaces, the company offers the
conga-BS77. It dispenses with the PEG
interface in order to execute three independent Digital Display Interfaces
(DDIs). Each can be configured as DisplayPort or TMDS (HDMI or DVI). In addition, one port can also be configured as SDVO output. LVDS and VGA are
available too. Up to seven PCI Express
lanes, four SATA ports with up to 6
Gb/s and RAID support, eight USB 2.0,
one EIDE and a Gigabit Ethernet interface allow fast and flexible system extensions. In addition to DirectX 11 and
OpenGL 3.1, OpenCL 1.1 is also supported. Fan control, Intel High Definition Audio, LPC bus for easy integration of legacy I/O interfaces, Intel AMT
8.0 for remote maintenance and the
new UEFI pre-boot applications round
out the feature set. Matching carrier
boards for quick evaluation and as a
template for customer specific designs are also available for COM Express Types 2 and 6.
We manufacture mechanical and precision engineering CNC-turned and -milled
parts as well as wire-eroded parts for a
variety of applications including medical
technology,sensor systems, measuring
and control technology.
www.congatec.com
Helmut Klingel GmbH · CNC-Zerspanung
Hanauer Straße 5-7 · 75181 Pforzheim (Germany)
27
Telefon +49 7231 6519-0 · Telefax +49 7231 6519-71
www.klingel-cnc.de · info@klingel-cnc.de
Sensors support many task in laboratory automation and make sure
that the processes are reliable, precise and efficient.
Filling the microtiter plates with the liquid to be analyzed is an imncreased automation in lab technology also increases the ways
portant part of the workflow. Sensors measure the fill level of the miin which sensors can be utilized to support and make sure that a
crotiter plate wells after a small amount of the substance has been
wide variety of tasks involved in automated lab processes are propipetted into the container and before the analysis process actually
perly executed. This is exactly why sensor and measuring instruments
begins. The sensors are thus able to check whether the amount is
manufacturer Baumer has developed a wide variety of solutions that
sufficient for the analysis or if too much liquid has been put in. Doing
ensure automated lab processes are reliable, precise and efficient.
this keeps waste to a bare minimum. Important qualities that system
Labs are where new diseases, vaccines or even artificial ingredients
manufacturers and users require of sensors are primarily precision
are studied and further developed. Growing automation in lab prowith good repeatability and a high slew rate. Furthermore, very little
cesses thus contributes to economic
Measure the
space is available for measuring the fill level. Some of the individual
efficiency. Even in the labs themselwell openings only have a diameter of 3 mm. The sensor must be
ves,
activities
such
as
pipetting
or
fill level precisely
able to detect the smallest deviations in the shortest amount of time
analyzing samples are primarily conthrough such narrow openings.
ducted today by machines. Machines work more efficiently and more
Conventional ultrasonic sensors operate by sending cone-shaped
precise than people. Sensors are visibly at work behind the scenes
sound waves. Because of this, their measuring spot size is too large
ensuring high process safety even with increased throughputs and
to be able to take a measurement inside openings that have a diamespeeds. Valuable samples especially call for precise measurements
ter of less than 10 mm. By working closely with customers, Baumer
with good repeatability. Sensors must also be able to withstand harsh
was able to develop the 09 series to circumvent this limitation. These
chemical substances or feature a respective hygienic design.
ultrasonic sensors are only 9 mm wide and are equipped with a speThe ways in which the different sensor solutions can be utilized in
cial nozzle that focuses the sound waves, thereby enabling the senlab automation is very extensive. They provide reliable support at the
sor to take measurements inside the very small openings of a micronumerous interfaces of the lab process. One of their most frequent
titer plate. Depending on the installation procedure, the nozzle can
tasks is measuring the fill level of liquids in analysis processes. Baube attached to the front or side of the sensors.
mer utilizes a wide variety of sensor technologies
The nozzle can be detached and replaced which
for this. In addition, very small containers such as
makes it easier to clean the sensor. Naturally,
microtiter plates and test tubes are used. Level conContact
these sensors are also capable of taking measutrol can ensure that replacing or refilling a contaiBaumer Group
rements in larger openings.
ner can be scheduled in advance, and Baumer ofInternational Sales
The sensors achieve a very high resolution and
fers various sensor technologies to accomplish
CH-8501 Frauenfeld/
repeat accuracy of up to 0,1 mm, which in a 384this. The portfolio range includes capacitive, phoSwitzerland
well microtiter plate, corresponds to a volume
toelectric and ultrasonic sensors. For example, with
Phone +41 (0)52 7281122
resolution of 1 μl. It has a very fast response time
the 09 series of ultrasonic sensors, Baumer is meeFax +41 (0)52 7281144
www.baumer.com
ting the challenge of being able to quickly and preof only 7 ms. Thanks to the special housing width
cisely measure fill levels in these containers.
of only 9 mm, the sensors are ideally suited for
MED engineering INTERNATIONAL 2013
28
© Carl Hanser Verlag, Munich
Photo: Baumer GmbH
Process Safety
in Laboratories
I
Laboratory Devices Sensors
MG110016
www.med-eng.de
1
The ultrasonic sensor of the 09 series measures the fill level of
liquids inside the very small openings of a microtiter plate
cascading. Using this approach, eight sensors mounted in a row can
scan a 96-well microtiter plate in a single pass.
Ultrasonic sensors are based on the principle of measuring the propagation time of sound in air. The sensor emits ultrasonic sound
waves that are inaudible to the human ear. These sound waves
bounce off an object and are picked up again by the sensor. Having
this functionality means the sensors
Identify and
are able to operate without any contrace samples
tact at all. This is especially advantageous in the lab area since neither
the medium to be analyzed nor the sensor are contaminated by the
measurement process. In addition, an ultrasonic sensor is exceptionally insensitive to relative humidity and dust which allows it to constantly work reliably. Since it operates with sound waves, it can reliably detect a wide variety of media regardless of transparency or color. The consistency of the medium to be examined does not impact the measurement either.
But there are numerous other applications that are able to make lab
automation more efficient. For example, vision sensors such as VeriSens are used for the important identification and traceability of the
samples. With the ID function of VeriSens, it is possible to read the
coding on test tubes or microtiter plates, such as barcodes, matrix
codes or text. The ability to combine several features makes it possible to conduct various inspection tasks in one step.
@
Precise positioning of pipetting arms is ensured by encoders which
Baumer offers in various versions. Depending on the application,
either absolute or incremental encoders are used to determine the
position information.
To prevent errors from happening even early on in the sample processing, photoelectric or ultrasonic sensors provide an essential
added value in pipette tip recognition by safely identifying the
type and number of the pipette tips. Baumer has developed solutions that especially have the required compact housing, a very
high resolution of up to 2 μm, and an incredibly short response
time of less than 1 ms. Fluid leaks or leakages that go unnoticed
can be particularly dangerous and expensive in lab automation.
Photoelectric sensors provide a reliable and constant way of monitoring this issue. Baumer's FODK 23 leak-monitoring sensor can
detect a leak that is as small as 1 ml. A special Teflon PFA coating
makes it also able to withstand chemically aggressive liquids.
Sensors ultimately contribute to the efficiency of lab automation. They
are able to recognize errors early on and thus maintain a high level of
quality. Sensors ensure flexibility and reliability thanks to their precision and the wide variety of applications that they can be used in.
Stefan Diepenbrock
is Manager Public Relations at Baumer Group in Switzerland.
sdiepenbrock@baumer.com
Company Profile
Pumps and systems for gases, vapors and liquids!
KNF Neuberger
GmbH
Germany
Alter Weg 3
D-79112 Freiburg
Tel. +49 7664 5909-0
Fax +49 7664 5909-99
info@knf.de
www.knf.com
For nearly 50 years KNF has been producing and
marketing diaphragm pumps and systems.
These are used when gases and vapors need to
be pumped or compressed, when containers
need to be evacuated and liquids pumped or
metered. The products are found for example in
equipment used for medical technology, analytics and environmental technology. A variety of
other applications such as in laboratories, the
cleaning industry and research round out the
range of uses.
The product line extends from small, fingernailsized gas and liquid pumps to liquid metering
pumps up to large gas sampling pumps with a
flow rate of 280 l/min (at atmospheric pressu-
29
re). A modular system for the pump head components and for the drive motors enables a
large number of stock configurations while forming the basis for custom product modifications. Over 32,000 such projects have already
been carried out.
A great advantage of the KNF diaphragm pumps
is their oil-free operation, which ensures unadulterated pumping of the media without contamination. The units are also maintenance-free,
compact and quiet. Thanks to the option of chemically resistant materials such as PTFE and
FFPM for the pump head and valves, as well as a
PTFE coating on the diaphragm, diaphragm
pumps for use with corrosive and aggressive
media are available. Special designs round out
the product offering, including pumps which
conform to ATEX for use in potentially explosive
atmospheres, or pumps with heated pump
heads.
KNF is an independent, innovative family group
with headquarters in Freiburg/Germany and
around 600 employees worldwide. The group
includes a global sales organization with 16 subsidiaries and a large number of representatives
www.knf.com
in major industrial countries.
MED engineering INTERNATIONAL 2013
MED electronics Q7-Computer-on-Module
Digital signal processors improve image processing and quality in
ultrasonic and X-ray applications. With compact Qseven modules development time of these applications will be significantly reduced.
tial still images are possible with 3D ultrasound imaging products.
ltrasound imaging products used nowadays for medical dia4D ultrasound imaging even permits three-dimensional displays in
gnostics and therapies have become indispensible. The adreal-time. Cross section views of a particular organ from any viewvantage of this method is that the sound waves, having a
ing angle can be generated or a virtual journey can be made through
frequency of between 1 and 40 MHz at a medium sound intensity
the human body.
of 100 mW/cm2, are not harmful to animal or human tissues. The
High-performance Computer-On-Modules (COMs) are increasingbasic technology, also called sonography, makes use of the diffely often used for fast development of innovative ultrasound imarent reflections of the ultrasound on the boundaries between tisging products. COM-based solusue and air, acoustically different tissues and on the boundaries
COMs are
tions offer standard PC functionabetween bone and tissues. The main applications in the medical
manufacturer
lity on the processor module and
sector include gall bladder and kidney examinations, cardiology, gyapplication-specific functions on a
necology, tumor detection, radiotherapy and ophthalmology.
independant
specially designed baseboard. The
In addition to electronics for the sound generation, an ultrasound
module is easily mounted on the baseboard via the proven stanimaging product comprises signal processing and image display, a
dard connector. Hence, the development complexity
variety of interfaces for the connection of
and design risk can be substantially reduced and dea monitor and printer as well as for stosign times can be significantly optimized. The embedrage media or a video camera. The ultraContact
ded modules offered meet defined standard specifisound probe (transducer head) is concations regarding format and performance and are
nected to the main unit via a cable. PrintMSC Vertriebs GmbH
D-76297 Stutensee/Germany
therefore interchangeable with products from diffeouts (sonograms) or video recordings can
Phone +49 (0)7249 9100
rent manufacturers. Furthermore, as a rule, a range of
be prepared as documentation from the
Fax +49 (0)7249 7993
different versions with scalable processor power are
monitor images. Ultrasound imaging prowww.msc-ge.com
offered, thus enabling a simple upgrade to a higher
ducts are available in a range of different
models, for example, small portable systems in personal digital assistant (PDA)
1 The Q7-TI8168
format or large desktop types.
Qseven platform is
Due to the increase in computing power,
based on the DM8168
and particularly through the progress in
DaVinci Digital Media
Processor, which intedigital signal processing, the image quagrates an ARM Cortexlity of ultrasound imaging products has
A8 RISC MPU and the TI
continued to improve in recent years.
C674x digital signal processor (DSP) core
For example, by means of digital sound
wave coding it is possible to clearly differentiate between ambient noise and
the sound wave used for image generation and thus improve the image resolution. Furthermore, beside the two-dimensional,
color-coded
Doppler
method, the amplitude-coded power
Doppler technology was developed. Spa-
MED engineering INTERNATIONAL 2013
30
© Carl Hanser Verlag, Munich
All photos: MSC Vertriebs GmbH
ARM and DSP
Ensure Rapid Imaging
U
» DSPs are designed
for demanding data
and imaging processing
analysis and reduce
the workload of the
ARM processor.«
Wolfgang Eisenbarth,
is Director Marketing Embedded
Computer Technology at MSC
performance for example. Likewise, a COM that has been used for
a long time can be exchanged with a more up-to-date COM, for
example with optimized power management functions in order
to minimize the power consumption. This possibility is particularly interesting for the implementation of mobile, battery-operated ultrasound imaging products.
Today, the Qseven standard, which defines modules in a compact
form factor of 70 x 70 mm, is widely accepted in many applications.
In addition to support for various x86 processors, the latest Qseven
Specification Revision 1.2 has added support for power-efficient
ARM/RISC architectures. In 2011, as one of the first providers, MSC
presented the Qseven embedded platform Q7-NT2 which is based
on the NVIDIA Tegra 290 low-power processor with dual core ARM
Cortex-A9.
In order to meet the demanding requirements of image capture
and image processing systems in the field of medical technology,
MSC now offers an additional Qseven module with ARM architecture (Figure 1). The high-performance Q7-TI8168 Qseven module
is based on the DM8168 DaVinci Digital Media Processor from
Texas Instruments (TI). The DM8168 integrates an ARM Cortex-A8
RISC MPU (up to 1.2 GHz) and a TI C674x VLIW floating-point DSP
core with up to 8000 MIPS/6000 MFLOPS.
Compact
and reliable
Panasonic PhotoMOS relays unify the
advantages of electromechanical relays and
semiconductors.
◗ Linear output characteristics
◗ No threshold voltage
◗ Low operate current (HS type 0.3mA)
◗ Low output capacitance (RF type 1pF)
◗ Absolute minimum leakage current (pA)
2 The Q7-MB-EP4
baseboard ensures
fast development
of high-performance embedded
systems, which are
based on the Q7TI8168 compact
Qseven module
family
◗ High I/O insulation (GU-E type 5kV)
◗ Low on-resistance
(HE type 0.035 Ohm)
◗ Extremely compact design
(VSSOP, SON, SSOP, SOP, …)
Panasonic relay technology permits fast,
silent and bounce-free switching with
extremely compact housing dimensions and
utmost reliability.
Panasonic Electric Works
Europe AG
31
4ELs&AX
info.peweu@eu.panasonic.com
www.panasonic-electric-works.com
MED electronics Q7-Computer-on-Module
@
MD110024
www.med-eng.de
Application Level Software
User Interface
Browser/Media Player
Applications
Application Frameworks - Java, Qt, GStreamer, Flash, Android, DShow, Direct Draw
video
picture
language
sound
encoder
and
frameworks
on NEON
A
OpenGL ES
and
OpenVG
On
SGX
2D
Graphics
Library
On
NEON
The C6EZAccel
software enables
acceleration of signal processing tasks
by using DSP optimized algorithms
(APIs)
OS kernel
ARM Cortex-A8 with USB on chip, High-end CAN controller (HECC) and Ethernet MAC
Accelerators – SGX 530 and Neon
The use of digital signal processors (DSPs) has great advantages, especially in the area of image processing, for example
in the analysis of ultrasound or radiography images in real-time.
Wolfgang Eisenbarth, Director of Marketing Embedded Computer Technology of MSC, explained: »DSPs are specially designed
for demanding data and image analysis in real-time. By managing these tasks, the DSPs can thus significantly reduce the workload of the integrated ARM processor. Furthermore, there is no
longer the need, as in the past, for the development of specific
software and its adaptation to the processor core.«
The ARM NEON media processing engine, integrated in the
DM8168, supports video imaging, speech, audio codes and frameworks. With the already optimized
Low energy
C6EZAccel and C6EZRun libraries
from TI, numerous tasks such as diprocessors allow
gital filtering, complex mathemobile devices
matical calculations, image processing and image analysis can be easily performed. C6EZAccel (Table A) enables acceleration of the signal processing tasks by using
DSP optimized algorithms (APIs). More than 130 DSP library elements such as OpenGL ES or 2D graphics are freely available to developers. C6EZRun executes the code porting, in order to run ARM
code on the DSP. In addition to MPU and DSP, the DM8168 DaVinci Digital Media Processor includes 32 kB instruction cache, 32 kB
data cache, 256 kB L2 cache, 64 kB RAM and 48 kB boot ROM. The
Qseven module Q7-TI8168 integrates 1 GB DDR3-1600 SDRAM and
a maximum of 2 GB NAND Flash memory.
The Q7-TI8168 embedded platform provides standard interfaces
such as PCI Express x1 port, Gigabit Ethernet interface, single
channel LVDS 24 bit with up to 1280 x 720 pixels and HDMI/DVI
interface. In addition, five USB 2.0 host and one USB 2.0 client
as well as AC97 audio and SPI interface are implemented. Con-
MED engineering INTERNATIONAL 2013
nection of a memory card is possible via the SD/SDIO interface.
User data can also be stored via two SATA II channels.
MSC offers the Q7-MB-EP4 baseboard (Figure 2) for immediate
use in embedded systems that integrate the Q7-TI8168 ARMbased Qseven module. The high-performance embedded platform, according to Wolfgang Eisenbarth, can also be put directly into production. Thus, in many cases, this saves the customer
complex in-house design effort.
Because the Q7-TI8168 compact
Interfaces for
Qseven module is easily mounted
interoperable
on the baseboard via a proven MXM
products
connection, there is a direct thermal
connection of the heat spreader to the metal enclosure. This ensures an optimal passive cooling. Thanks to the implemented Direct
Digital Interfaces (DDI) the digital video signals of the module go
directly to the Digital Visual Interface (DVI) connector.
The baseboard measures 148 x 102 mm and provides a wide variety of important interfaces such as dual Gigabit Ethernet, five
USB 2.0 ports (four external), RS-232 (pin header), AC97 audio
and SATA. In addition, CAN signals are available via a special pin
header. Furthermore, an ARM RS-232 debug port for Linux software development is provided. Industrial displays can be connected via the Digital Visual Interface (DVI) connector and the
Low-Voltage Differential Signaling (LVDS) interface directly via JILI30 connector. Additionally, the platform integrates a controller for the connection of a resistive touch screen and supports
the connection of a backlight.
In order to further extend the functions on the baseboard, for
example for the support of wireless local area network (WLAN), a
mini PCI Express slot is provided. The mSATA slot provides an easy
way to add a SATA-based Flash memory card. The baseboard can
also be individually configured by customers via the integrated
MMC/SD card slot.
32
© Carl Hanser Verlag, Munich
Table A source: Texas Instruments
Board Support Packages
• Linux – Open Source – TI developed
• Android – Open Soure – TI funded
• Windows Embedded CE – TI owned
(developed by Microsoft Gold Partner)
• Commercial Linux und Android – many partners
• RTOS – QNX, VxWorks, Nucleus, Integrity
and others
MED electronics FPGAs Instead of DSP and MCU
Motor controllers are often based on user-specific circuits. However,
complex applications can be developed more efficiently and economically on FPGA platforms.
Sophisticated Drive Systems
for Tomorrow
T
tems and links to customer-specific user interfaces are required.
Many such applications are based on DSPs and MCUs. However,
these are subject to limitations concerning performance, scalability and extensibility.
Due to their power and flexibility, FPGAs offer a genuine alternative in demanding drive applications. They make it possible to integrate the functional blocks for the operation of a process controller with drives on one chip. The high control cycle rates that
are achievable in combination with the high integration density
and scalability play a central role in drive technology. Thanks to
their high performance, FPGAs cope with a wide variety of applications in medical technology.
1 Drive controls such
as in automatic liquid
handling can be implemented in a highly integrated and scalable
manner with FPGA
technologies
Photo: iStockphoto: David Gray Photography
Single-chip solutions save money
he requirements for motioncontrol applications in medical technology are changing
constantly and place high demands on drive systems. In addition to high demands on dynamics, precision and computing
power for track calculations, the
central issues are the price, the
form and the modularity of the
system. Moreover, in integrated
solutions, interfaces to other sys-
33
MED engineering INTERNATIONAL 2013
2 An evaluation kit facilitates the rapid prototyping
of a functional model
One advantage of FPGAs is the possibility of mapping several softcore processors within one chip. The time-critical real-time requirements can be separated from non-time-critical operations. The data traffic in systems with many bus users is thus reduced to a minimum, resulting in increased robustness. This softcore architecture
offers the advantage compared with MCU systems of making it possible to combine several chips in a single chip. Besides reducing space requirements on the PCB, this also saves costs.
Especially when drive-controlled systems have to be highly integrated, inherent advantages of FPGA architecture becomes obvious. The high computer power provided by the softcores and the
high time resolution make it possible to achieve the required dynamics in the control circuits
Control systems in
and at the same time to accomreal-time with FPGAs
modate the process controller
on a single chip. Thus, for
example, embedded processors such as the NIOS II (32-bit RISC)
can take over process control with I/O, filter or interface functions,
with the flexible DSP blocks providing the computer-power intensive algorithms for motor control. The high performance is reflected, for example, in the application of field-orientated control
(FOC). The key to FOC's success is the real-time control of the sinusoidal, 3-phase motor current. On the basis of the motor current
value that is sampled at a rate of 100 k Samples/s, all necessary
control parameters such as speed, slippage moment and torque
are calculated at an FPGA cycle rate of 100 MHz and the motor
speed and angle are adjusted via PI control loops. The required
algorithms are available and easily implemented as FPGA-IP, not
only for FOCs but for all
commonly available controller types. By combining
Contact
ready-to-use, tested IPs and
Pantec Engineering AG
customer-specific code
LI-9491 Ruggell/Liechtenstein
blocks, the time-to-market
Phone +423 (0)377 1333
and hence also the time-toFax +423 (0)377 1334
cash are considerably rewww.pantec.com/dynamics
duced.
MED engineering INTERNATIONAL 2013
3 FPGA software modules for a comprehensive singlechip drive control
However, efficiency in the development process by no means stops
here. The processors available on the FPGAs make it possible to
easily migrate existing C-code from process algorithms, for example, to NIOS II softcore. FPGA development systems also offer debugging tools, which permit access to the lowest levels. This creates the prerequisites for the system analyses required for FDA
certifications, for example. In addition to the capacity for general
control technology, FPGAs offer sufficient power for demanding,
application-specific requirements.
In order to read on...
...read or download the complete article in:
www.med-eng.de/MG110022
Lorenzo Huber
is Head of the Business Unit Dynamics at Pantec Engineering in
Ruggell, Liechtenstein.
lorenzo.huber@pantec.com
34
© Carl Hanser Verlag, Munich
All photos and source of figures: Pantec Engineering AG
MED electronics FPGAs Instead of DSP and MCU
MED electronics Embedded ATX Boards
The high quality of signals and images achieved with the Micro-ATX
board makes it possible to perform digital Doppler and duplex sonography with one and the same device. The long-term availability of the
board protects the user’s investment.
Photo: Compumedics DWL
Measuring the Speed
of Blood Flow in Real Time
Contact
Fujitsu Technology
Solutions GmbH
D-86199 Augsburg/Germany
Phone +49 (0)821 804-3177
Fax +49 (0)821 804-3177
www.de.fujitsu.com
Compumedics DWL
Germany GmbH
D-78224 Singen/Germany
Phone +49 (0)7731 797690
Fax +49 (0)7731 797699750
www.dwl.de
1
D
oppler sonography makes it possible to measure the speed
at which blood flows through certain vessels. Superior to
more elaborate diagnostic methods when it comes to visualizing the haemodynamic situation of the vessels, sonography is
a non-invasive, reproduceable method which does not expose the
patient to any radiation and which enables the diagnosis of vascular anomalies and embolisms provided that the Doppler or duplex
device offers a high degree of signal and image quality. Combining
the Doppler and duplex technologies by using a Doppler color imaging module results in a full set which, by offering two methods,
mainly supports complex applications and specialized functional
tests in scientific research.
35
Today, the range of applications for Doppler systems is
wider than ever and can include neurology, neurosurgery, cardiovascular surgery, anaesthesia, intensive
care, or ENT surgery. With
the help of transcranial
Doppler sonography (TCD),
vascular anomalies and embolisms cannot only be detected but also analyzed.
Such blockages of blood
flow in the brain precede a
stroke. If they are detected
and treated in time, a stroke
can be prevented. Furthermore, it is possible to study
CO2 reactivity and autoregulation as well as reactions to
certain medicines.
The Doppler M mode makes
it possible to measure even
through the deepest
layers and to visualize
the data in real time
Compumedics DWL specializes in the development of
devices for Doppler and duplex sonography. One advantage of transcranial
Doppler sonography is that it can be performed in a flexible,
quick, and cost-efficient way with portable equipment. For visualizing the blood flowing trough the brain, doctors usually use
Doppler probes because this method, possibly the most current
so far, is the more sensitive of the two. Duplex probes (Figure 2)
are usually used for visualizing the carotid arteries at the neck
which supply the brain with blood.
In order to read on...
... read or download the complete article in:
www.med-eng.de/MG110019
MED engineering INTERNATIONAL 2013
MED electronics RoHS and REACH
Until now, neither RoHS 2 nor REACH has been a topic in medical industry. By June 2014 medical device manufacturers have to demonstrate the compliance of their products. The question is make or buy?
All photos and figures : TQ-Group
E10 in Electronic
Medical Technology
By 22nd of July 2014 all electro medical devices put on the EU market have to be RoHS compliant
A
few years ago, the topic of RoHS compliance came up in
the electronics industry. As with every major technological
innovation, there was initially a certain degree of panic in
the market. Two important questions had to be answered: do all
components come in identical RoHS versions? How do the production processes work, especially lead-free soldering? Some
manufacturers used the changeover to clean up their product portfolio. Today, electronics manufacturers have a handle on production processes. Until now, it has not been mandatory for medical
products to conform to RoHS 2. REACH was not a topic either. But
this will change due to an amendment of the law by June 2014. All
manufacturers, with only a few exceptions, must demonstrate the
compliance of their products. What is RoHS 2 about? Additional
MED engineering INTERNATIONAL 2013
hazardous material protection regulations apply to electromedical devices first introduced into the EU as of 22/07/2014. These
are laid out in the new RoHS-II directive 2011/65/EU (Restriction
of the use of certain Hazardous Substances), which went into effect on 21/07/2011. It replaces the earlier directive 2002/95/EC,
whose scope did not yet include meFirst step:
dical products. The directive must
be implemented in national law no
parts list analysis
later than 02/01/2013. Common
substances in electronics are often highly dangerous to the environment, as they are both toxic and cannot be disposed of easily or at all. RoHS is intended to prohibit these substances from
being used in products. This affects the following: lead, mercury,
36
© Carl Hanser Verlag, Munich
current
design
PowerSolutions
for industrial and medical systems
parts List
analysis
r
RoHS/REACH
compliant?
No
search for
substitutes
Yes
edit
parts List
No
Medical Powe
+
O
anty
3-Years-Warr
+
O
ailable
Long-Term Av
+
O
Yes
redesign
analyze
production
process
production
RoHS/REACH
compliant?
No
make or
buy?
Make
reorganize
production
DIntegrated UPS function
DVarious battery packs
DWith USB interface
Yes
E2 MS
compliant
product
1
mNSP3-450P-USB
ATX Nonstop Power
Buy
The way to RoHS-2 compliance
RoHS-, OM- &
REACHmonitoring
© MED engineering INTERNATOINAL
BEO-1500M
Fanless Solution
cadmium, hexavalent chromium, polybrominated
Contact
biphenyl (PBB), and polybrominated diphenyl ether
TQ-Systems GmbH
(PBDE).
D-82229 Seefeld/Germany
According to the original directive, these substanPhone +49 (0)8153 93080
ces should not be used in products at all. Since this
Fax +49 (0)8153 4223
requirement could not have been implemented
www.tq-group.com
from a production point of view and small quantities could not be detected analytically, concrete
threshold values for homogeneous materials in the products were
established in an amendment to the directive on 18th of August
2005 (sources: directive 2002/95/EG, directive 2011/65/EU). Directive (EC) No. 1907/2006 (REACH directive) is an EU chemicals
directive that went into effect on 1st of June 2007.
REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. As an EU directive, REACH is equally and directly applicable to all member states. REACH harmonizes and simplifies existing chemicals regulations. The list of substances of very
high concern contain:
In order to read on...
...read or download the complete article in:
DPowerful and very compact
DHigh efficiency up to 93 %
DExtended temperature range
BET-1200M
ECO-Friendly Design
DErP and CEC level V compliant
DPowerful desktop adapter
DSecure, robust and reliable
Let's meet in Hall 2.117
www.med-eng.de/MG110018
37
Bicker Elektronik GmbH
Phone: +49-906-70595-0
www.bicker.de
1
C-Leg users enjoy
every step
Trusting the Next Step
T
hose who have to live with an amputation frequently have to
overcome many hurdles on a daily basis – be it stairs or an
uneven forest path. With the right leg prosthesis, such hurdles are easy to overcome. The C-Leg is an intelligent leg prosthesis system that makes the life of transfemoral amputation patients
much easier. Worldwide, more than 40 000 supplies with the CLeg prosthesis system confirm the advantages of this unique technology. Medical technology specialist Ottobock developed the leg
prosthesis. Ottobock has shown
How does
stable growth for many years and
as global leader in the field of prosthe C-Leg work?
thetics, it sets the benchmarks for
the industry. The company builds on the mature C-Leg technology, which has proven itself time and time again since 1997. And up
to today, C-Leg is constantly being developed further. For the current model, which has been introduced into the market in July
2011, many developments have been implemented. The prosthesis is now certified for a maximum body weight of 136 kg.
The intelligent knee joint permanently detects the current phase
of the gait cycle and adjusts accordingly in realtime. The knee
angle sensor supplies the information needed for dynamically controlling the swing phase, depending on the respective step length
MED engineering INTERNATIONAL 2013
and frequency of the prosthesis wearer. The joint hydraulically
limits the maximum bending angle during the swing phase, e.g.
when the leg prosthesis is in the air during the gait cycle. On the
new C-Leg, various mechanical and electronic adjustments allow
improved swing phase control. As a result, the prosthesis user has
a more natural gait and improved ease-of-movement in the knee
joint. Whether the wearer is taking the stairs or maneuvering
through a packed shopping mall, taking a leisurely Sunday stroll
or rushing to work – the CLeg system automatically
adjusts to all situations.
Contact
Uneven ground, darkness
maxon motor ag
or a crowded environment
CH-6072 Sachseln/Switzerland
is also no longer an insurPhone +41 (0)41 6661500
mountable problem, as the
Fax +41 (0)41 6661650
high resistance secures the
www.maxonmotor.com
C-Leg during the stance
Otto Bock HealthCare GmbH
phase and the knee joint
D-37115 Duderstadt/Germany
only switches to the swing
Phone +49 (0)5527 848-3411
phase when it is necessary.
Fax +49 (0)5527 848-1414
This significantly reduces
www.ottobock.de
the risk of falling when
38
© Carl Hanser Verlag, Munich
Photos 1 + 2: Ottobock Healthcare GmbH; Photo 3: maxon motor AG
Enjoying life to the full –taking carefree strolls through shopping malls,
cycling with friends or perhaps going on a mountain hiking tour. With
the right leg prosthesis, being active can be part of day-to-day life again.
Ottobock and maxon motor give people new quality of life.
Prosthesis DC Motors
2 On the new C-Leg, diverse mechanical and electronic adjustments
allow an improved swing phase control
wearing a leg prosthesis. The C-Leg also offers a special mode that
allows it to be configured for various activities such as cross-country skiing or cycling.
In this additional activity mode, the amount of hydraulic dampening depends on the knee angle. The initial dampening and the
progression can be configured individually. Thus the behavior of
the leg prosthesis can be programSmall motor,
med for diverse activities beyond
normal walking. To enable the proslarge effect
thesis to withstand the stress to
which it is subjected daily, the high-activity frame of the prosthesis is made of carbon, an extremely stable, high-quality and light
material. The frame covers the electronics, the hydraulics and the
battery.
How exactly does the C-Leg technology work? The intelligent
controller of the prosthetic system adapts to the individual gait
of each individual. The control operations are performed via a
microprocessor-controlled hydraulic unit that dynamically
adjusts the system to all gait speeds. Simultaneously the controller ensures that the prosthesis is reliably secured during the
stance phase. This tried-and-tested control mechanism is achieved by means of a complex sensor system. The sensors
record the load every 0,02 seconds, or, to be more precise, the
sensors measure the ankle moments above the foot fitting component, as well as the angle and angle speed of the knee joint.
Thus the knee joint permanently detects the current gait phase
of the prosthesis wearer. A lithium ion battery powers the C-Leg
and lasts approximately 48 hours.
The characteristics of the hydraulics are adapted by means of two
valves. These valves are adjusted by maxon RE10 DC motors. Two
motors are used in each C-Leg. Here one of the main strengths of
the RE10 is its compact size. With a diameter of just 10 mm, the
motor is the second-smallest DC motor in maxon motor's portfolio. This, combined with the CLL system for a long service life,
played an important part in Ottobock's decision to use these high-
39
precision motors. The motors furthermore have
ironless windings and neodymium magnets that allow top performance
at a minimum size.
3 RE 10 DC-Motor
has a diameter of
Precious-metal brushes are used for me10 mm a length of
chanical commutation of the motors.
17 mm and deliThis ensures detent-free running of the
vers a performance of 0.75 W
maxon motors, even at low speeds. During commutation using brushes, contacts are constantly opened and closed
via the inductive load of individual segments of the motor winding. The sparks
generated when the contacts open
attack the metal brushes and commutator of the motor, by melting the surface.
This brush fire reduces the life span of the commutation system
of the motor. By means of the capacitors integrated in the motors,
the life span is significantly increased.
The CLL principle (capacitor long life) means that an additional element is inserted between two adjacent commutator segments,
e.g. parallel to the opening contact. Through the use of the CLL
concept, the brush fire is largely suppressed. Furthermore the
spark reduction also has a positive influence on the electromagnetic radiation.
In the C-Leg, the maxon motors have to operate in pulse mode or
intermittent mode, that means the motor is only activated for a
short period for adjustments and is not constantly in use.
Ottobock estimates that nine million such adjustments are made
during the life span of the C-Leg. On average, the motor performs
ten rotations for these adjustments.
For many leg amputees, using the C-Leg is a completely new experience. Contrary to other prostheses, the user of C-Leg do not have
concentrate on every step. »It is not exhausting at all, it is impressively simple and I was really surprised. Now walking is fun again – almost
like it used to be,« says Ed from America, who lost his leg in a car accident but has nevertheless been standing in a bakery for many years.
The success story of the C-Leg continues as more and more people
are switching to this intelligent leg prosthesis and are achieving amazing things with it. In 2011, 74-year old Roland Zahn crossed Germany on foot, from Leipzig to Tübingen – with his C-Leg as trustworthy
companion. And a 60-year old woman climbed in the Himalayas at
altitudes up to 4000 m with her prosthesis.
Anja Schuetz
is editor to maxon motor in
Sachseln in Switzerland.
Anja.Schuetz@maxonmotor.com
MG110015
www.med-eng.de
@
MED engineering INTERNATIONAL 2013
New Products
KNF Neuberger has introduced the micro diaphragm
pump NMS 010 for corrosive or aggressive media. It features high pneumatic performance, compact dimen-
ment, only 13 mm wide. It weighs 23
grams including drive motor. Despite
its size, the pump transfers 0,75 liters
per minute. It achieves an ultimate
vacuum of 600 mbar absolute and
Micro Diaphragm Pump
sions, low noise and low power
consumption. The pump is
very small and, by
using an oval-diaphragm pumping ele-
an
overpressure of
200 mbar. Due to the
enclosed housing, the pump
generates very
little noise running
on an energy efficient
drive motor. The product is oilfree in operation and transfers the
media without contamination. The
carefully selected materials for components contacting the media make
this pump suitable for transferring
corrosive or aggressive media.
www.knf.de
Modular
Roll Stands
Integrated cable management system.
CIM med offers a mobile cart series. Conceived for daily work in a clinical setting, the roll
stands are ergonomically designed, easy to
clean and made of high-quality materials. Each
model bears the CE mark and complies with
the Medical Device Directive MD 93/42 EEC.
The mobile mounts can be perfectly adapted
to the needs of clinical personnel. They are
made of eloxized aluminum and feature an integrated cable management system, thus offering a great deal of flexibility and meeting
high standards of hygiene. The devices are easy to clean and resistant to hospital-grade disinfectants. The centerpiece is a base with five rollers that gives optimal stability
and is available in a variety of versions depending on need. The small cruciform
base made of aluminum can carry over 30 pounds (15 kilos) without a counterweight and is therefore a real space saver. For greater burdens, a heavier base of steel with asymmetrical cantilever arms provides the requisite stability. The
two models are equipped with high-quality double rollers and are easy to maneuver. A conductive version is also available. The column of the roll stand provides many options for individual situations. All carrier arms and components
can be slipped onto the C-profile of the column. In order to enable quick and
efficient configuration of workstations, the company also provides baskets, cable hooks, infusion holders, drawer consoles and trays in addition to normed
tracks and handles.
www.cim-med.com
MED engineering INTERNATIONAL 2013
Mini Circular
Connectors
Cost-effective for small medical devices. MiniMax from Fischer Connectors
is a rugged push-pull interconnect solution for small medical devices. An all-inone 20 signal (0,5 A) and 4 power (5 A) connector with a patents-pending 24
mixed contacts passes extreme temperature tests, is sealed to 120 m (both mated and unmated) and resists 1000 hours of salt water spray. Because of its small
profile of less than 7 mm inside the box the connector applies more connections into a smaller space. Nevertheless power and signal do not interfere with
one another. The MiniMax is cost-effective because the connector itself is small
and the 24-contact configuration can mean fewer connectors are used. Since
fewer cables are needed, the entire device becomes cost-effective and stays reliable. The solution is also pre-cabled which saves time. The keying system withstands over 4 Nm of torque and the over-molded assemblies are able to withstand 40 kg of pull (break-away) force. The connector is available in three
latching systems: push-pull, breakaway and screw lock.
www.fischerconnectors.com
HOERBIGER launches an
electrohydraulic lifting column for operating tables that allows
moving heavy patients. The column’s
design is robust and simple and re-
grees. The new model is consistent
with current operating methods, in
which clinic staff pays particular attention to low height in the retracted position. The product is designed for
Electrohydraulic Lifting
quires little space. It was
developed
specifically
for a patients’
weight of up to
180 kg (lifting force:
3000 N) and an installation height of 450
millimeters with a
stroke of 350 mm.
The compact yet
powerful lifting column allows lateral adjustments of ± 30 degrees and
tilt adjustments of ± 20 de-
40
continuous operation with
10 000 cycles.
Other features
are that it is maintenance-free, energy efficient and - compared
to strictly electric drive
systems - very quiet and
precise to operate. The
lifting columns are distributed by HOERBIGER
Micro Fluid in Barbing in
Germany.
www.hoerbiger.com
© Carl Hanser Verlag, Munich
Antimicrobial Cables
Long-lasting hygiene benefit
Leoni is using a new acid-based
technology that gives plastic
surfaces a germ-killing effect.
The use of antimicrobial device
housings, cables and cords in
hospitals or doctors' surgeries
can contribute substantially to
increasing the standard of hygiene and minimising the risk
of infection. Unwanted gaps in
the hygiene chain can thereby
be closed. The plastic surfaces
near patients of monitoring devices and their cables can
cause infections in hospitals
when they are contaminated
with germs. This risk can be
substantially lowered with the
use of antimicrobial cables
whose special properties are
similar to the principle of the
human acid protective layer.
Surfaces that are treated with
this new technology very quickly display a significant reduction in germs. The effect is
microbiologically verified, with
the evidence provided by an
accredited laboratory using a
recognised
measurement
method and independent hospital hygiene experts. The test
involved the most well-known
and most frequently occurring
hospital bacteria as well as
germs that have developed resistance, applying various incubation periods and concentrations. The method that Leoni
applies follows the Lewis acidbase theory: it involves acid
ions being released on the sur-
per method is susceptible to
perspiration and protein, meaning that, in normal use, the antimicrobial effect on a treated
plastic object is considerably lowered or deactivated. Another
benefit of the new technology
is that the pathogens are destroyed not from the inside, but
from the outside across the cell
envelope; the formation of
what are known as biofilms on
the cable or the device housing
is thereby stemmed, and its
surface can be more easily
cleaned. Furthermore, the metal oxide that is incorporated in
the plastic does not come under the controversial nanotechnology because of its larger
grain size.
www.leoni.com
face of the cables that lower the
pH value on the outer surface
of the jacket. This restricts the
cell functions of the germs and
their separation, so that they ultimately die. This is made possible by permanently incorporating a special metal oxide in
variable doses in the plastic matrix of the cable jacket. Even in
low concentration a significant
germ-killing effect is already
evident. The mechanical properties of the cable remain unchanged. These innovations
provide several advantages versus the hitherto common
methods. A key benefit is that
this acid technology maintains
the hygienic effect. By contrast,
the established silver and cop-
Company Profile
Tubes and Profiles
Novoplast
Schlauchtechnik GmbH
Germany
In den Langen Stücken 6
38820 Halberstadt
Tel. +49 3941 6869-0
Fax +49 3941 6869-40
medizin@schlauchtechnik.de
www.schlauchtechnik.de
For more than 20 years Novoplast Schlauchtechnik GmbH located in Halberstadt / Germany
produces thermoplastic tubes and profiles in
highest precision for various applications in the
industrial technology like machine building, agricultural engineering and numerous special applications as well as in the medical technology.
We process more than 300 different plastics
beginning with standard materials and ending
with temperature or chemical resistant „High
Tech“ materials. Our production is equipped
with the latest laser and ultrasonic measurement devices. We are certified according to
DIN ISO 9001 and DIN ISO 13485.
In cleanrooms class 8 and 6 our medical tubes are
produced covering a diameter range from 0.2
mm up to 20 mm, i.e. including micro extrusion.
We manufacture monolumen tubes, multilumen
tubes and multilayer tubes for various applications like e.g. infusion, transfusion, nutrition,
angiography, urology, dialysis, drainage, PTCA.
Besides these specialised products we offer
several medical PVC/PVC-noDOP and PU tubes
41
*
as a standard for infusion, transfusion, ECC and
dialysis.
In closely coordinated product development
projects, our high-level material and technology
expertise enables us to develop out specific
solutions and to achieve them series-production rediness.
The range of our industrial tubes contains e.g.
several standard tubes like pneumatic tubes
made of PU and PA, coiled tubes, insulating
tubes, hydrolysis and microbial resistant tubes,
chemical resistant and food safe tubes, tubes
made of TPE, TPEE or PVDF and flexible (spiral
coiled) brake hoses.
Novoplast Schlauchtechnik GmbH – The right
choice
* Connecting Values – for the best connections, simply ask our
sister company FLEIMA-PLASTIC
www.fleima-plastic.de
MED engineering INTERNATIONAL 2013
MED Informatics Model-based Software Development
Software for safety-critical systems is subject to strict requirements,
and so is the way it is developed. If development is model-based, it
helps developers meet these requirements.
Developing
Safety-Critical Software
M
odern medical devices
contain an increasing
amount of software – for
example for sensor control or device networking. Depending on the
application, the software has to
meet the requirements for safetycritical applications. The standards
governing software for medical devices are IEC 62304 and IEC 61508
[1], which define requirements and
MED engineering INTERNATIONAL 2013
make recommendations from the very first development phases to
the finished software. Two major aspects are the early, comprehensive validation of all functional requirements and the traceability of
all development steps.
Models leave no room
A great part of the control
functions for pacemakers, infor interpretation
sulin pumps, blood pumps
and other devices consist of software. Because of the high complexity involved and the safety requirements, manufacturers have
to guarantee that the device’s software provides exactly the functions that were specified and that the functions work as defined.
42
© Carl Hanser Verlag, Munich
Photo left: dSPACE GmbH
Thus, the specifications themselves must contain unambiguous, comprehensive function descriptions. Model-based
development, in which a function is described by graphical
models in MATLAB/Simulink/Stateflow, is a proven method
of implementing these requirements. First, unlike purely
textual function requirements, models leave no room for interpretation and avoid misunderstandings. Secondly, models
provide specifications that are executable by simulation,
which allows early verification (Figure 1).
Moreover, automatic code generators like dSPACE TargetLink
can directly convert the models into source code. Changes
in a specification or model can therefore be simulated, verified, and then automatically implemented as high-quality
code in fast iteration steps. The model and the code remain
consistent at all times. The implementation can then be easily verified in various tests with tool support. For users, this
means shorter development times, more efficient workflows
and high-quality code. These three benefits are so convincing that the automotive and aviation industries are increasingly or even primarily using model-based development.
Safety-critical software plays a key role in medical engineering, where it has to comply with standards such as IEC 62304 and
IEC 61508. Safety-critical software is also developed in numerous
other industries, where model-based development has become a
proven and routine procedure, since it helps users meet the requirements defined in industry-specific standards. Another major aspect of developing safety-relevant software, in addition to
correct functionality, is the traceability of requirements. It has to
be possible to prove at any time that all the function requirements
have been implemented exactly as described and have been tested comprehensively.
There must be a guaranteed ability to track from requirement to
implementation to associated tests and back in all steps, and even
a long time after the software has
been
released and while it is in use.
Guidelines to
Ideally,
all the requirements are deincrease safety
fined from the very beginning, for
example, in requirements management tools or in Microsoft Word
or Excel documents. To ensure traceability between the requirements and the model parts that implement them, model-based development uses bidirectional links [2]. Users can therefore quickly
and seamlessly track whether requirements have been met and how.
In automatic production code generation, these links even reach into the code, guaranteeing complete traceability from the requirements to the model to the code. For example, hyperlinks in an HTML
representation of the code lead back to the linked model part. In addition, users can generate up-to-date status reports at any time to
monitor the status and maturity of individual functions.
To ensure that functions are reliable, modeling and coding guidelines should be used, as recommended in IEC 62304. These guidelines contain rules and restrictions for using languages and the
blocks available in MATLAB/Simulink. MISRA C [3] is an established
standard for the widely used C programming language and implements these recommendations at code level. MISRA also publishes
MISRA AC TL, special guidelines for the automatic production code
43
Requirements
Verify requirement changes
quickly by simulation
Modeling
+
+
x
1
2
0,4
KL
Model
Code
generation
c
h
Verify implementation
easily by back-to-back
tests
Source code
Implement specification
changes quickly
by code generation
Compile
& link
obj
Object code
© MED engineering INTERNATIONAL
1
Workflow for model-based software development
generator dSPACE TargetLink [4]. The focus is on development support for safety-critical software, so that possible sources of error
are avoided at both the model and the code level. The modeling
guidelines for TargetLink also particularly address safety-critical
aspects. Other objectives are enhanced readability and efficient
code generation.
Different safety classes apply to medical software depending on
the application. IEC 62304 defines acceptance criteria for each
class: For example, the code has to comply to the applicable coding
standards (see IEC 62304, section 5.5.3). In model-based development, there are guideline checking tools that automatically test
whether these criteria have been met and automatically proove it.
These tools also efficiently check large models for guideline compliance, so they can and should be used even in early stages of development. The generated
source code can also be
Verify completeness
checked, for example, by the
and correcteness
MISRA C Checker. In addition to
coding guidelines, the acceptance criteria also cover verification
steps such as simulation, different kinds of tests, documentation
and reviews: Different simulation modes for the model (modelin-the-loop (MIL) simulation), the host implementation (softwarein-the-loop (SIL) simulation) and the target implementation (processor-in-the-loop (PIL) simulation). These methods (Figure 2)
avoid work-intensive iterations in late development
phases and save time and
Contact
money by:
Verifying at an early stage
dSPACE GmbH
D-33102 Paderborn/Germany
by means of model simuPhone +49 (0)5251 16380
lation, that the model
Fax +49 (0)5251 161980
and requirements are
www.dspace.com
correct
MED engineering INTERNATIONAL 2013
MED Informatics Model-based Software Development
Model-in-the-Loop
Controller model
Software-in-the-Loop
C code on host PC
Processor-in-the-Loop
C code on target processor
Evaluation
board
Plant model or stimulus signals
2 MIL, SIL and PIL
simulation modes
avoid exhausting
iterations
Plant model or stimulus signals
Plant model or stimulus signals
© MED engineering
Verifying that the code and the
mode are consistent, and that
the code correctly represents the
model's functionality, by simulating the generated code on the
host PC
Verifying seamless traceability
for documenting the software
development
Allowing resource requirements
to be estimated at an early stage
by simulating the code on the appropriate evaluation hardware
Comparison tests, i.e., performing
tests with the same test cases or
test stimuli in different simulation
modes and comparing them
(Figure 3) are methods that reduce
the time required for the necessary tests despite a high volume of
tests and low development costs.
These advantages result from:
Verifying that the code represents model behavior correctly
and fulfills the requirements in
terms of functionality
Comprehensively testing for errors with tools that generate test
vectors partly automatically and
that support the comparison of
simulation results, automatically generated evaluation, and
documentation
Verifying that system behavior is
robust even with invalid preconditions or input values
MED engineering INTERNATIONAL 2013
Code coverage tests at model and code level provide results in
high-quality models and code by verifying that compared with all
theoretically possible tests, the tests cases that were actually developed and executed are sufficient for covering the functional requirements.
Reviews at model or code level in which the model and the code
are linked to provide quicker and more complete reviews and
therefore enhanced model and code quality.
In model-based software development, not only can the code be generated automatically from the models, the software documentation can also be generated with a single click. Specification and implementation changes are automatically included and do not have
to be documented manually. Template mechanisms and existing API
interfaces enable users to adapt the form and contents of the documentation simply, quickly and individually, either as they see fit or
according to formal documentation requirements. The model
structure and other items such as graphical plots showing the simulation results can be added to the automatically generated documentation to represent the model's dynamic behavior. The requirement
information can also be included to show the consistency between
the requirements and the model. Because the requirements are
linked to the corresponding model parts and code sections, requirements management software can be used to integrate the verification results directly into a status report. The report shows whether
tests were already performed and passed for each component.
The development of safety-critical systems imposes additional requirements and restrictions on the software development process. Experience from different industries has shown that complex, safety-critical applications can be developed successfully with
model-based development and automatic production code generation. Some aspects of the model-based development processes
were described as examples of how to support compliance with
the requirements of safety standards such as IEC 62304 and how
to automate software development steps.
44
© Carl Hanser Verlag, Munich
MG110014
www.med-eng.de
@
Test stimuli
Target compiler
and linker
TargetLink
C code
Model
Simulation
(e.g., MIL)
Object code
Execution
(e.g., PIL simulation on
the evaluation board)
3 Comparison
tests reduce the
time required for
the necessary
tests even when
the test volume is
really big
Signal comparison
Results (references)
Results
© MED engineering
Literature:
[1] IEC 61508-3: Functional Safety of Electrical/Electronic/Programmable
Electronic Safety Related Systems – Part 3: Software Requirements
Dipl.-Ing. (FH) Sonja Lillwitz
is Marketing Project Manager at dSPACE in Paderborn, Germany.
SLillwitz@dspace.de
[2] Tracing Requirements to Design, Tests and Generated Code,
www.mathworks.com /products/simverification
[3] MISRA C: 2004 Guidelines for the use of the C Language in critical systems,
MISRA 2004 (MISRA (Motor Industry Software Reliability Association),
www.misra.org.uk)
[4] MISRA AC TL: Modeling style guidelines for the application of TargetLink in the
context of automatic code generation, 2007, Version 1.0s
Dipl.-Ing. E-Technik (TU) Doreen Krob
is Product Engineer for TargetLink at dSPACE in Paderborn,
Germany.
DKrob@dspace.de
Company Profile
Kontron in Medical
Embedded Technology for Medical Solutions
kontron
Germany
Oskar-von-Miller-Straße 1
85386 Eching
Tel. +49 8165 77-777
Fax +49 8165 77-279
sales@kontron.com
www.kontron.com
Kontron is a full-service medical OEM solutions
provider offering customers innovation and longevity through highly integrated applicationready platforms. Kontron enables you to drive
innovation with innovative products. Products
are designed to enable longevity by quick
design-in time and outstanding lifecycle
management.
Kontron understands the extensive and evolving
requirements of the medical equipment industry. We strive to be the best resource possible
to our customers beginning with design ser-
vices and customization to environmental and
agency testing, certifi cation, production and
program management, and extended lifecycle
management.
Many of Kontron’s products and custom designs
have been EN 60601-1 certified alongside the
industrial environmental standards.
Longevity & Lifecycle Management
Kontron offers availability for boards and platforms up to 7 years, and longer.
Extended Software Services
The Kontron Global Software Center is the company’s central service point for handling the
increasingly complex software functionalities of
customers’ embedded computing solutions,
thereby helping OEMs to reduce their time to
market and improve the quality of applications.
www.kontron.com
45
MED engineering INTERNATIONAL 2013
New Products
NuSil Technology has launched a heat-cure colored inks series, MED6613-X. The colors — red, white, green, bright blue and dark blue — vastly expand the company’s color palette and provide more vibrant, creative marking options. NuSil’s inks are characterized by a long work time and non-volatile content of approximately 60 percent. Depending on the ink color, viscosities range from 800 to 3000 cP and can be decreased through dilution via
compatible solvent. These two-part, addition-cure inks can be used in pad-printing and silk-screening processes for marking or coloring silicone rubber parts,
Silicone Ink Colors
Tritan Copolyester
Unchanged after sterilization
and chemical-resistant. Eastman
Chemical Company’s Tritan copolyester is a BPA-free material that provides toughness and chemical resistance. The copolyester maintains clarity and color after sterilization, providing excellent aesthetic appeal. A
device’s shape and dimensions also
remain intact after both ethylene oxide (EtO) and gamma sterilization.
Additionally, chemical resistance and
solvent bonding with tube systems
are not affected by either procedure. The copolyester was used by
A. Hopf to design their 3-way stopcocks and Y-connectors for use in enteral feeding systems, cytostatic therapy and infusion and transfusion
therapy, such as blood therapy. In
relation to the use of raw material,
Tritan copolyester meets the demands of USP Class VI, which judges the suitability of plastic material
intended for use as an accessory for
parenteral preparations, and FDA/
ISO 10993, which evaluates the biocompatibility of medical devices to
help ensure patient safety.
www.eastman.com
such as catheters. Because their cure is accelerated with heat, these inks
are suitable for applications requiring a rapid
cure time. In fact, the suggested cure schedule is
just five minutes at 150°C
(302°F). »With adjustable
viscosities and cure schedules allowing for versatility of processing, the inks can be used on a wide variety of medical devices,« says Brian Reilly, Product Director — Healthcare Materials. This line of silicone inks was a collaborative effort between NuSil Technology for silicone development and C.I. Medical, Inc. for application feedback.
They are designated unrestricted and may be considered for long-term implant
applications of 29 days or longer. Each lot undergoes cytotoxicity tests, and a
Master Access File will be filed with the FDA for each ink color. »CI Medical, Inc.,
with its long term relationship with NuSil, was pleased to be involved with the
development of this new series of medical grade silicone inks,« means Bruce
Mahan, Engineering Manager – CI Medical, Inc. »The inks’ excellent printability
and vibrant opaque colors illustrate the synergy that can be realized when combining the expertise of NuSil with that of CI Medical.«
www.nusil.com
Micro-Spaghetti Tubing
Thin and stable walls. Reichelt Chemietechnik presents its new THOMAFLUID Micro-Spaghetti Tubing for Analytic Technology that is of particular interest especially for biochemical research. A characteristic feature of this
tubing series is its high dimensional
stability despite the minimum wall
thickness. The smallest tubing size inside is 0.51 mm with a wall thickness
of 0.91 mm. The dimensional stability is ensured by the production method since the tubing is manufactured by means of a mandrel bar. An absolutely smooth inner surface of the
Spaghetti-Viton-Tubing ensures that
no foreign substances can be deposited on the inner wall of the tubing. Its
MED engineering INTERNATIONAL 2013
temperature resistance is –30°C to +200°C, for a short time up to +300°C,
which is of great importance for laboratory technology. FKM/FPM are copolymers of highest quality made of fluorinated hydrocarbons. Fluorinated rubber belongs to the most expensive
elastomers besides FFKM. Its outstanding elongation at break is particularly advantageous in peristaltic pump
technology when organic as well as inorganic media e.g. vegetable and animal oils, aromatic and fluorinated solvents, many acids, alkalis and oxidants
have to be delivered. The Viton MicroSpaghetti Tubing for analytic technology is available in delivery units of 1,
5 and 10 m. www.rct-online.de
46
© Carl Hanser Verlag, Munich
Company Profile
Improving Lives through Innovation
Gardner Denver
Thomas GmbH
Germany
Benzstraße 28
82178 Puchheim
Tel. +49 89 80900-0
Fax +49 89 808368
thomas.de@gardnerdenver.com
www.gd-thomas.com
Gardner Denver Thomas has been meeting the
pump and compressor needs of OEMs for over
50 years. Simply put, we’re specialists in serving
original equipment manufacturers. In fact, over
90% of everything we produce goes into an OEM
product.
The performance of customers’ design ultimately depends on the quality and dependability of
its components. That’s why so many original
equipment manufacturers of medical equipment have entrusted their reputations to
Thomas.
With a wide range of pressure, vacuum and
liquid technologies including: WOB-L piston,
articulated piston, diaphragm, rotary vane, linear and peristaltic, Thomas offers the broadest
product range in the industry.
The flow range of gas pumps extends to 360
l/min with a pressure of max 12 bar and a vacuum of 99% local barometer. The liquid pump
range goes to 3000 ml/min and a maximum
pressure height of 80 m water column. With this
vast product offering, Thomas can design an
ideal, custom pressure or vacuum solution that
can be prototyped and manufactured to meet
the customers’ precise needs.
In addition to the OEM, Thomas also designs and
manufacturers a wide range of products for the
construction, laboratory, leak detection and
medical markets.
Thomas employs over 900 people in 25 countries. With three manufacturing facilities in
North America, Germany and China, 25 wholly
owned group companies and 18 distributors
Thomas is uniquely positioned to serve cuswww.gd-thomas.com
tomers world wide.
Company Profile
Over 6,500 slip ring sysems for CT’s – every year!
Schleifring und
Apparatebau GmbH
Germany
Am Hardtanger 10
82256 Fürstenfeldbruck
Tel. +49 8141 403-0
Fax +49 8141 403-45
sales-med@schleifring.de
www.schleifring.com
Our customers are specialists in complex technical products for the aerospace, energy industry
and automation as well as the medical sector.
The outstanding quality of our precision products in medical technology is proven and we
are constantly setting new standards with our
high-tech portfolio.
We maintain a global network of sales, service
and manufacturing establishments to be close
to our customers throughout the world.
As market leader SCHLEIFRING meets the complex and demanding requirements for sophisticated electrical rotary joints and slip ring
systems for CT scanners throughout the world.
These rotary joints ensure the supply of power,
the transmission of all bus signals as well as the
contactless transmission of digital image data.
All SCHLEIFRING slip ring units are all individually
customized according to customer specifications by our highly skilled engineering team.
We place a high priority on retaining our most
precious asset, our knowledge, by developing
and producing all components in-house to
produce the best results to your full satisfaction.
Our service for you:
• In-house development and manufacturing
• Assembly and testing
• Assistance at qualification
• Worldwide service support on-site
Our highly qualified sales team takes care of
your interests and your product from development stage to delivery and beyond.
www.schleifring.com
47
MED engineering INTERNATIONAL 2013
Materials Multi-lumen Tubes and Catheters
Multi-lumen catheters enable different functions in order to promote
less invasive procedures. Whether its development will be a success
depends on precise specifications and a trustful communication
between designer and manufacturer.
multi-lumen catheter can be
a critical element to the success of a minimally invasive
device. Its fabrication, however, can
prove to be a significant challenge.
To ensure that the finished, multilumen catheter meets a user’s
functional needs, it is important to
Contact
Helix Medical Europe SE & Co. KG
D-67661 Kaiserslautern/
Germany
Phone: +49 (0)631 53417500
Fax
+49 (0)631 53417600
www.helixmedical.de
1 In order
to produce this
9-hole multi-lumen tubing
functional requirements and tolerances should be clearly definend and the material to be employed carfully
selected
MED engineering INTERNATIONAL 2013
define the design, material, and performance requirements as
accurately as possible with the available information. Clearly articulating these requirements with knowledgeable material selection and specifying the desired application will provide the optimum successful outcome within the shortest delivery time.
Any gaps in information, due to confidentially concerns or key facts
that are not available, can greatly impact the material and design
selection process. Specifications
Well defined
that are not accurately defined will
specifications
most likely lead to elongated program timelines with an associated
increase in costs. Spending the time to clearly define the requirements and partnering with a qualified manufacturer who is able to
achieve the goals set for the project will save both time and money.
As expected, there are numerous configurations available that are
based on the requirements of the component tubing and/or finished device. A successful outcome will be accomplished through
the communication, imagination, and technical capabilities of the
designers and manufacturers. In order to develop and produce a
multi-lumen catheter, the genesis is in the specifications for the
required tubing. The catheter could be generated from
a single or multiple extrusions to achieve the desired result.
Other alternate construction techniques may
be employed in the “building up” of individual layers of materials and tubing. This
complex extrusion incorporates diverse materials not chemically compatible, such as
braid/coil reinforcement, PTFE liners.The following information outlines considerations that,
when taken into account before manufacturing, lead
to a functional and cost effective outcome for the medical device customer.
Biomaterial selection – any material, surface, or construct that interacts with biological systems:
Biocompatibility – consider anatomical areas of use
and length of time in contact with the body
Hardness – single or multiple combinations of
materials with different hardness along the shaft,
measured in durometer, affect compressibility,
column strength, kinking, stretch
48
© Carl Hanser Verlag, Munich
All photos: Helix Medical Europe SE & Co. KG
The Way to Perfect Catheters
A
Temperature sensitivity – What impact will
temperature have on the performance of
the catheter?
Sterilization – the method of sterilization will have a critical bearing on the materials used and the packaging concepts
employed
2
When selecting the biomaterial for endoscope
catheters biocompatibility
or the sterilization method
have a great influence
Mechanical requirements – acceleration and
deformation (both elastic and plastic) of
devices/components under known forces or
stress:
Torque – rotation of the catheter about
its axis (twist)
Ability to push or advance tubing – a determined advance against opposition;
column strength (the ability to advance a
catheter within body structures or catheter guides)
Kink Resistance – maintaining the inner bore diameter over a
specified bend radius (resistance to collapse)
Functional requirements – fulfilling the purpose of the device or
component:
Co-efficient of friction of the outer/inner lumens – incorporating PTFE or FEP liners to provide a lower co-efficient of friction
in order to deploy or pass a device through one of the inner
lumens with ease
Bend radius – incorporating spiral coils to achieve the required
bend radii and maintain the inner bore diameter (kink prevention)
Steering – the steering wires may be incorporated into the smaller lumens. Steering capability allows the operator directional
control at the distal end of the catheter
Braid/coil construction (for reinforcement of the tubing)
Varying diameters (inner or
outer)
Incorporation of additional components (e.g., hypo-tubing,
wires, electrical conductors, and
marker-bands)
Material stack-up for reinforced
catheters – the outer jacket must
have enough coverage (i.e., wall
thickness) to ensure that there
are no exposed wires, or that the
surface of the catheter will not
be compromised due to
manipulation of the catheter during the procedure
Construction – the translation of design into reality:
Varying flexibility (incorporation of different material durometers)
Tolerance – permissible limit(s) of
variation in devices/components:
The tolerance specification
Experienced manufacturers assure
high quality
Optical Components
s#ONlGURABLE$IGITAL-ICROSCOPES
s(IGH-AGNIlCATION#-OUNT/BJECTIVES
s4ELECENTRIC,ENSES
Solutions in Optics - Reduced to your Needs
www.opto.de
49
MED engineering INTERNATIONAL 2013
Materials Multi-lumen Tubes and Catheters
Controlling a pain management catheter precisely e.g. in the spine area is of
great importance. Incorporating steering
wires has to be considered carefully in design to ensure this functionality
must be functional and manufacturable
Too tight a tolerance – does not
allow for variation, which is evident in complex parts
Too great a tolerance – accessories (i.e., handles) will not have
an adequate fit to the part
Mutual
communication
@
MG110027
www.med-eng.de
Validation – confirming that the
medical
product/component
meets the needs of its users: The
key component for accurate, repeatable catheter construction is
attributed to quality extrusion capabilities together with robust validated processes. Validation of extrusion is a difficult task, even for
simple single-lumen tubing. The introduction of ultrasonic capabilities
has made it possible to verify the
product rather than validate the
process itself. It is possible to verify OD, ID, concentricity, ovality and
wall thickness 100 percent of the
time. However, ultrasonic verification does not work for all of the attributes of multi-lumen tubing.
Therefore, the traditional validation process needs to be carefully
considered. When considering the
validation of a multi-lumen tube,
careful attention should be paid to
the following:
Functional requirements of the
product need to be considered in
order to prevent over-engineering that may lead to manufacturing and validation difficulties
Tolerances involved are tied to
the specific materials used to
produce the catheter. When specific Cpk values are required, it is
MED engineering INTERNATIONAL 2013
necessary to pay very close attention to
specifications and tolerances. As less
invasive medical procedures utilizing
smaller catheters have entered the
market, extrusion tolerances have become tighter and tighter, leading to
challenging validation processes
dimensional specifications are critical and need to be considered. For example, wall thickness is usually stated with
±tolerances. It may be perfectly acceptable to only set a minimum specification on the wall thickness, rather than having
a two-sided tolerance
materials employed need to be deliberated when discussing
validation. Softer materials and thin-walled materials are much
more difficult to manufacture and, therefore, more difficult to
validate
As with most medical devices, the route taken for validation of a
multi-lumen tube should consider the IQ, OQ, and PQ processes.
When it comes to validation of extrusion, the process can be carried out in a slightly different format. The OQ process can be avoided, going from IQ straight to PQ verification runs. The reason is
that extrusion tends to run in a closed-loop control process, where
the dimensional inspection readings of the OD (taken from SPC
software) are used to feed information back to the extruder, thereby making continual adjustments of the processing parameters of
the extruder. This ensures that the dimensional specifications of
the product are maintained 100 percent of the time. Thus the requirement of an OQ is not deemed necessary.
The key components for accurate repeatable catheter construction are attributed to excellent communication; acceptance of requirements and specifications; and repeatable, quality extrusion
capabilities – all together with robust validated processes.
A distinct advantage for developing complex catheter devices is
realized when the provider has the key knowledge, process capabilities, and resources in-house to facilitate rapid project turnaround, in addition to meeting all quality requirements and providing the customer an attractive and acceptable cost/value ratio.
Helix Medical Europe provides tailor-made catheters for sophisticated applications in cooperation with its Irish partner companies
Vistamed and Cambus Medical – all part of the Freudenberg Group.
Furthermore is Helix Medical a one-stop-shop for medical components, produces tubing and precision moulded parts of silicone
and thermoplastics in clean room production in its German facility in Kaiserslautern. Those products can be upgraded to customized solution packages by additional features such as surface coatings and treatments or pad printing, tip trimming and precisioncut-to-length.
Linda Maher
is development engineer at the Helix Medical subsidiary enterprise Vistamed Ltd.
in Carrick-on-Shannon, Ireland.
Imaher@vistamed.net
50
© Carl Hanser Verlag, Munich
Photo: Helix Medical Europe SE & Co. KG
3
New Product
Optical Diffusers
Continuous diffusion adjustment
Edmund Optics announces the release of its new electronically variable optical diffusers. These versatile diffusers are fully tunable
and offer excellent flexibility for a wide range of integration solutions. These electronically variable optical diffusers utilize a liquid
crystal film to vary the degree of optical diffusivity from near-Lambertian to clear. The diffusion angle can be continuously adjusted
using a convenient control knob. Diffusion angles (FWHM) range
from 1° in the clear state to 70° in the fully diffused state. The diffusers feature a spectral range of 400 to 1500 nm, a 25 mm aperture, transmission of 85 percent and a fast response time of 10 to
20 ms. Featuring C-Mount mounting threads, the electronically
variable optical diffusers are compatible with Edmund Optics' full
range of C-Mount components, facilitating integration with additional optics illumination, and sensors. Electronically variable optical diffusers are designed to replace a full lab of diffusers, excellent for research and prototyping uses. For example, during the
prototype phase, the user can tune to the diffuser needed for the
given application and then purchase a diffuser with those specifi-
cations for the final OEM application. Gregory Fales, Product Manager, Edmund Optics, explains: »Electronically variable optical diffusers feature a simple user interface and the diffuser's adaptability allows the user to tune to the customer's specific needs, making this an ideal choice for taking an optical system from design
to prototype to production.« These electronically variable optical
diffusers are ideally suited for applications including biophotonics
research, holography, neutral density filtering, preventing oversaturation of detectors or optically characterizing materials. The
diffusers are in-stock and available for immediate delivery for fast
turnaround and excellent value.
www.edmundoptics.com
Company Profile
Imaging for Medicine - a life-saving technology!
STEMMER IMAGING
GmbH
Germany
Gutenbergstr. 9–13
82178 Puchheim
Phone +49 89 80902-0
info@stemmer-imaging.de
www.stemmer-imaging.com
Having the right perspective in medicine means
being able to diagnose illnesses earlier, to
improve treatments or even save lives. Modern
medicine depends on imaging for the diagnosis
and real-time monitoring of operative procedures. STEMMER IMAGING provides the right
technology for it.
therefore is to install all of these image sources
in the hospital environment, to hold different
cable concepts for this, to operate the cameras,
to transport the image and video data, to
display, document and archive the image data,
or also to make the images visible for remote
diagnostics.
In medicine there is a wide range of medical
imaging equipment, such as Endoscopes,
microscopes, X-ray, CT scans, MRIs or operating
room monitoring cameras. These image sources
use different interfaces, resolutions, video standards, control options etc. A major challenge
This is exactly where STEMMER IMAGING comes
in with newly developed concepts and products, e.g. the "Medical Video Server" that can
acquire, manage and display any standard
image or video source and distribute the data
via LAN / WAN, or with small, modular interface modules for GigE cameras often used in
surgical lights or as surveillance cameras in
operating rooms. Apart from that, STEMMER
IMAGING offers many other products for
image acquisition, image processing and archiving.
As Europe´s largest technology provider for
image processing, STEMMER IMAGING is your
ideal partner for image processing in medicine.
Imaging is our passion.
www.stemmer-imaging.com
51
MED engineering INTERNATIONAL 2013
Materials Carbon Fibre Reinforced Polymers
1 Example of a radiolucent CFK targeting device in hybrid design
2 The individual parts of this radiolucent clamp
were realized from different PEEK semi-finished
products with varying fiber content and design
according to their particular requirements
In contrast to surgical metal instruments, instruments made of
carbon fibre reinforced polymers are radiolucent. To switch from
metal to CFRP requires an experienced partner in engineering and
manufacturing.
a composite of fibers and a high temperature polymer which
urgical instruments made of carbon fiber reinforced polyserves as a matrix material. The embedded fibers in the matrix
mers (CFRPs) are highly appreciated due to their interesting
determine the mechanical properties of CFRPs with regard to
strength to weight ratio in comparison to metals. With the
fiber quality, length, orientation and percentaged content.
use of medical imaging, the most important advantage is radioluShort fibers within composites are mostly non-orientated. Higher
cency, or to be more precise, free of artifacts. Other important
strength can be achieved by the use of long fiber CFPRs. The long
properties are chemical resistance against disinfectants, autofibers may be orientated in the shape of a knitted fabric or plane
clavable by moist heat as well a haptic and attractive optical apby plane in a parallel alignment in a composite.
pearance.
The preferred matrix material is polyetheretherThe requirements of surgical instruments are
ketone (PEEK). However, Gsell Medical Plastics
demanding. Material and design are chalContact
offers proved and tested alternatives for matrix
lenged by the repeated use in surgery in terms
Gsell Medical Plastics AG
materials as well. Furthermore, thermoset epoxy
of mechanical forces and hot steam sterilizaPhone: +41 (0)56 6754040
matrixes are available if lower requirements are
tion. Strength, durability and dimensional staE-mail: info@gsell.ch
needed in terms of hot steam sterilization and
bility are indispensable. The requirements of
www.gsell.ch
biocompatibility.
these radiolucent instruments are fulfilled by
MED engineering INTERNATIONAL 2013
52
© Carl Hanser Verlag, Munich
All photos: Gsell Medical Plastics AG
Surgical CFRP Instruments:
More than Radiolucent
S
Material suppliers normally process matrix materials and short
fibers to resins, while long fibers are processed to so-called prepregs. Resins are further converted by injection molding or extrusion. On the other hand, prepregs are wrapped around frames, layer-wise pressed into forms or processed to plates with a thickness
of up to approx. 50 mm. The fiber content may be up to 50 volume percentage and beyond. The proof of biocompatibility is essential for the later use of these semi-finished products in surgical instruments which may come into contact with injured skin,
tissue or bone. The international standard ISO 10993-1 preferred
determines the scope of testing.
The processing of semi-finished
Long fibre CFRPs
products is challenging due to the
high hardness of carbon fibers
increase strength
which are embedded in a matrix.
Near net shapes are cut by water jet out of compressed plates for
further machining to instrument components. Due to an intense
collaboration between tool and machine suppliers and our own
CFRP production department, significant progress has been
achieved in recent years. It allows Gsell Medical Plastics to economically machine with high feed motion and best surface quality. This
also applies to circumferential radii, rounding offs and 3D geometries which dominated manufacturing costs in the past.
Short fiber reinforced thermoplastics may be processed by injection molding to finished parts, to blanks or to near-net-shapes for
further processing. Fiber orientation can be varied in certain limits
according to part and tooling design as well as process conditions
which have an influence on the mechanical part properties. An appropriate part design is required for each fiber reinforced material involved. OEM suppliers should be integrated in the design process as early as possible. It allows taking care of technical and economic aspects without having to impair the functionality of instruments.
Design changes are generally necessary if metal instruments are
replaced by CFRP instruments. Multi-layer plates achieve the excellent material strength values
Tensible strength only in one plane for example. Delamination of the layer composition
of 1800 MPa
may be caused by lateral stress.
When possible, long fiber reinforced material is preferred in use
for more complex and larger geometries. The higher fiber content
already reduces deformation of the component during manufacturing as well as in later operation. The orientation of long fibers within the matrix should follow the force path to accommodate highest requirements. By doing so, tensile strengths of over 1800 MPa
may be achieved.
It is not always possible to manufacture radiolucent instruments
without metal parts. They are therefore built in hybrid design. In
the so-called targeting devices in traumatology (Figure 1), metal
parts acting as drilling gauges have to be precisely loaded and incorporated into the capable device. Multi-part instruments need
to be dismountable for the adjacent cleaning process after use in
surgery. Metal locking elements or thread inserts reduce excessive wear which might have an impact on function and precision
of targeting devices. Beyond plastic metal hybrid design, different
53
3 In comparison to
metal materials, FRPs are
well suited for external fixation devices
with regard to their mechanical properties,
radiolucency, and sterilizability
plastic components may also be used in one assembly in terms of
PEEK , PEEK with carbon long fibers, and PEEK with carbon short
fibers (Figure 2). It is always important to evaluate the individual
specifications of each component to determine the optimum performance to price ratio.
CFRP products are in versatile use in medical technology. Radiolucent targeting devices (Figure 1) enable the precise insertion and
fixation of intramedullary nails using
Little weight and
medical imaging. Furthermore,
CFRP retractors are in use in surgehigh elasticity
ry. CFRPs can not only be found in
surgical instruments but also in other medical applications. As well
as weight reduction and good mechanical properties, radiolucency is the main advantage when using CFRPs for external fracture
stabilization fixators (Figure 3). Thereby, X-ray imaging allows observation of the consolidation of bone fracture without X-ray shadows which might complicate or prevent imaging interpretation.
Weight reduction and elasticity decide on the use of CFRPs for artificial legs. With the given radiolucency, CFR PEEK also used in use
for implants, such as spine cages and osteosynthesis plates, thanks
to biocompatibility and to interesting mechanical properties of
this material [1]. Further applications can be found in surgical navigation systems and radiotherapy devices.
Even the most robust device is subject to mechanical wear and
there is a possibility it may get damaged. A factory based maintenance service by the OEM suppliers allows cost-efficient provision of refurbished instruments again with in a short turn-around
time. This service completes the services of Gsell Medical Plastics.
The company has been a dedicated partner for CFRP instruments
machining for many years.
Literature:
[1] Roland Wieling: CFK fibre reinforced PEEK medical implants.
European Cells and Materials Vol. 16. Suppl. 2, 2008: 8
Tilo Callenbach
is Managing Director at Gsell Medical
Plastics in Muri, Switzerland.
Patrick Fässler
is Sales Engineer at Gsell Medical Plastics in
Muri, Switzerland.
MG110026
www.med-eng.de
@
MED engineering INTERNATIONAL 2013
Materials Plastic Couplings
Plastic couplings do not only guarantee a save connection at room
temperature but also at high temperatures in autoclaves or at very
low temperatures in cryotherapy.
Plastic Couplings are
a Safe Bet
1
Non-spill couplings guarantee a completely nonspill work environment
D
Quick and easy
connections
uring regular maintenance or assembly
of spare parts you may
find tubing connections that require frequent line disconnections
and connections. These processes
can be made safer, easier and more
efficient by specifying quick connect/disconnect couplings. A large
number of factors can influence the
choice of the right coupling if you
take into consideration the broad
range of different coupling types
currently available. With the right solution, the result will be a leak free
connection and a tight seal that
guarantees a secure connection and
disconnection. This in turn helps ensure that the user does not come in-
MED engineering INTERNATIONAL 2013
to contact with the media, that the tools are protected and that the production processes can be optimized.
But not every coupling automatically guarantees a completely nonspill work (Figure 1) environment. And it is this functionality in a
quick-disconnect coupling that creates a work-space where the
spillage of fluids – and the time spent cleaning up from them – is
eliminated. In this way, users benefit from a higher level of protection against the risk of contamination due to leaks or spills. The
different types of couplings can be defined by the market applications they serve with different couplings for industrial, medical
and chemical applications. In Life Sciences connectors for reusable and disposable connections are used in blood pressure monitoring, surgical, dialysis and patient therapy devices. In the singleuse technology you will find connections between flexible bag systems, tube assemblies, bioreactors and other bioprocessing equipment. The trend leans towards the requirement for quick and easy
connections, which can easily influence the design of a coupling
and its closure mechanism. Most couplings in the Colder Products
54
© Carl Hanser Verlag, Munich
Contact
Colder Products
Company GmbH
D-55252 Mainz-Kastel/Germany
Phone: +49 (0)6134 28780
Fax
+49 (0)6134 2878-28
www.colder.com
All photos: Colder Products Company GmbH
Company series feature a thumb latch design.
This is a solid mechanism that allows an easy connection and disconnection with one hand. Another closure mechanism, a flexible plastic
latch design – featured with the SRC series – can disconnect a coupling upon slight
pressure. The twist-to-connect option (i.e. SMC series) is absolutely secure when connected and
allows a disconnection with a twist.
Plastic material
The BreakAway Design of a quick
reduces weight
disconnect allows a quick and automatic break of the connection – when needed – without depressing a latching mechanism. In the past, this type of disconnection
was only seen in metal couplings, but it has been successfully implemented in plastic through Colder’s long industry experience.
Past experience has shown that plastic is a very reliable material
allowing a cleaner, faster, safer, and smarter way to make reliable
connections. With the introduction of plastic quick disconnect
couplings more than 30 years ago Colder has proved that plastic
is a reliable and suitable material for this market segment. Nevertheless some applications still specify a robust material, like metal, because of its strength and performance. There still remains
the perception that metal is more durable than plastic, especially
at cold temperatures, but modern plastics can now withstand
heavy impact, even in extreme cold.
Across many industries, there is crowning recognition of the importance of plastic. This was first seen in the aerospace industry,
and today plastics are widely used in the automotive industry as
well, primarily on chasses but also in the support frames for engines and transmission systems. When using plastics, reductions
of as much as 50 percent in cost, and 70 percent in weight, can be
achieved. At the same time, plastic also offers increased flexibility, which in turn impacts the functionality of a product. In every
situation, manufacturers must ensure that any changes or
improvements in design, material use, or functionality directly correlate to an increased value for the customer.
Standard plastic materials, such as polypropylene, offer resistance
to environmental stress cracking and can be exposed to challenging environments. Technical plastics, such as Polyoxymethylene
(POM), exhibit high strength and rigidity over a broad temperature range, are low-wearing, and are strong enough to withstand
the stresses of repeated use. High performance thermoplastic materials, such as polysulfone, have excellent strength good chemical resistance and can better withstand repeated sterilization and
higher temperatures than other thermoplastics. Lightweight and
high-strength reinforced plastics can be molded into practically
any desired form and the properties of the material can be accu-
55
2 Six different media can
be transported in these multi-tubing
connector, coupling six different lines
rately adapted to the required specifications. Glass-reinforced plastics, for example, are extremely strong and durable, increasing the
safety of the final product.
An important step within the selection process is to determine the
correct O-ring material. Depending on the application specifications, some materials can offer higher chemical resistance while
others have better heat resistance or flexibility at lower temperatures. In the medical device industry quick disconnect couplings
can be of service as an attachment to tubing, in a medical device
or on the outside of such a device. Many medical devices designs
feature connections for fluids or air
RFID for a
on the backside or within the device. In these cases the functionasave connection
lity is more important than form
and appearance.
If a device has to integrate more than one connector then multitubing connectors (Figure 2) are the best choice. Colder offers
standard connector options for two, six and ten lines that allow
the connection of several tubing lines and the transportation of
different media within a single connector.
If there are connections that require the integration of fluid and
electronics, Colder’s Hybrid Connector can be the best choice. This
connector integrates fluidics and electronics into a single connection point. It eliminates the need for multiple connections and simplifies the user interface between remote tools and a device. Medical professionals can quickly change or replace modular tools,
umbilicals or hand pieces that require power, signal, air or fluids
in a wide range of medical device applications.
Another option that offers more functionality is the integration of RFID (Figure 3) in quick coupling systems. The unique
MED engineering INTERNATIONAL 2013
Materials Plastic Couplings
@
MG110020
www.med-eng.de
IdentiQuik Smart coupling innovation integrates RFID technology
into couplings and package closures or inserts. Before the final
connection of the body and insert is made, the IdentiQuik automatically exchanges product data to control the connection and
the process. These couplings series protect brand integrity, improve safety and help realize significant cost savings.
But an RFID solution is not always needed if there are other options – like color or mechanical coding – that can support the application better. On the one hand color coded connections, such
as the series 4 and 6 Non-Spill couplings, are offered in different
colors and can ensure that misconnections are avoided. In addition the soft touch overmold provides an easy grip and a pleasant
handling experience. On the other hand mechanical coding can
help the user to always make the right connection as this solution
prevents mismatched connections due to keyed parts. These provide foolproof connections for non-interchangeable
lines.
Established and proven technology can be
presented in a new look if a user needs more
than just a “part” and is instead looking for an
overall solution. Colders engineered solutions
team is able to design application-specific
options that solve customers’ problems
and offer improved product performance.
During this process, Colder is able to identify, and implement, the latest trends in the
medical market. Many manufacturers of medical devices rely on
Colder’s quick disconnect couplings and fittings to provide secure connections and disconnections for a broad range of applications. Colder couplings allow autoclaves to drain easily. These devices are used to sterilize equipment and supplies by subjecting
them to high pressure saturated steam at 121°C for around 15 till
20 minutes depending on the size of the load and the contents.
You will also find Colder quick disconnects on endoscope reprocessing machines. While the use of these high-cost devices has become more routine, the cleaning and disinfection procedures involved with reprocessing the equipment can be challenging.
These coupling products provide a leak-free connection between
internal endoscope channels and endoscope washing devices during the disinfection process.
Another interesting device, which helps to reduce pain before a
surgery and to accelerate the healing process after an operation,
is cryotherapy, which is the local or general use of low temperatures in medical therapy. Colder has designed a custom solution
that integrates two non-spill coupling sets into one connection
component. During that cooperative process, Colder developed a
plastic housing that integrates plastic couplings with RFID and nonspill functionalities, creating an easy to use connection module for
this type of treatment device. This gives medical personnel better
control and increased security during the treatment. The integrated RFID technology avoids misconnections, identifies fluid characteristics and captures a lot of connection, patient and treatment
data. Implementing two non-spill couplings into one housing
MED engineering INTERNATIONAL 2013
3 In couplings, package closures or
inserts with integrated RFID technology,
product data are exchanged
and wrong connections are avoided
allows the
manufacturer to reduce assembly time and provides an
easy to use and lightweight
device – both important targets for the customer. These
medical application fields use standard couplings but specifically designed custom solutions as well.
Custom-designed couplings might
be extremely important for OEM
applications where the efficient integration of an OEM product is key.
Due to the close cooperation between supplier and manufacturer,
Colder has built up a strong bank of
expertise in the manufacture of
high quality custom solutions.
Working with customers help to
create connection solutions that
are specifically designed for their
needs and reflect the individual
product requirements.
Ingo Mohr
is application engineer at Colder Products Company in Mainz,
Germany.
Ingo.Mohr@colder.com
56
© Carl Hanser Verlag, Munich
Company Profile
RECOM Electronic GmbH
Reinforced DC/DC Converters with 3rd Edition IEC-60601
Recom
Electronic GmbH
Germany
Carl-Ulrich-Str. 4
63263 Neu-Isenburg
Tel. +49 6102 88381-0
Fax +49 6102 88381-62
info@recom-electronic.com
www.recom-electronic.com
RECOM offers a wide range of DC/DC converters
that are certified to the stringent requirements
of the IEC/EN 60601 – Medical Equipment standard.
ISO-14971 Risk Management files have been
completed, which are necessary for the successful certification of the final product.
The product portfolio includes fully certified
DC/DC converters with a power range from
0,25W up to 15W. For example the RAM (1W,
unregulated), RAZ (1W, regulated) and RTM (2W,
unregulated) series, offer an isolation voltage up
Company Profile
to 4kVDC and an operating temperature range
up to 100°C. For higher wattages the regulated
converters of the series REC10 (10W) and REC15
(15W) are suitable. They achieve efficiency up to
87% and can be used in ambient temperatures
of between -55°C and +71°C.
The “/R” series have a specially designed reinforced isolation transformer core and new insulation materials to ensure that not only the 3rd
Edition of IEC-60601 required clearance and
creepage distances are observed, but also
higher isolation voltages of up to 10kVDC can
be guaranteed. The reinforced isolation series
meet the highest safety category and have two
safeguards for the protection of patients
(2 x MOPP – means of patient protection).
The RxxPxx/R and RxxP2xx/R series (1W and 2W
respectively) are isolated up to 8kVDC and available in a space-saving SIP7 case size. The 2 watt
version is also available in a DIP24 case (RV
series), making a changeover to the new technology simple without requiring a new PCB layout in many cases. The REC3.5 and REC6 series
have 3.5 and 6W power rating, are isolated up to
10kVDC and come in a standard DIP24 case. For
all RECOM 3rd Edition Medical converters the
57
Driven by Innovation & Quality
As a partner to a wide variety of industries, our
product range is synonymous with reliable highquality solutions in the range of 0.25 to 60 watt,
either with AC or DC input. Decades of experience in power supply have given us an excellent
position to supply innovative products with cutting-edge circuit topology and state-of-the-art
components which meet every safety standard,
as our certificates show. Quality takes top priority along with innovation at RECOM, quality that
we guarantee in our in-house quality assurance
laboratory; all of our products come with a
three-year or five-year guarantee.
Sales, Service & Technical Support
Worldwide
We've risen to the global challenge in a product
range with service excellence and technical support available almost anywhere in the world. We
have a worldwide distribution network that
leaves virtually nothing to be desired – whether
internationally active distributors or regionally
specialised partners. Give us a try!
www.recom-electronic.com
MED engineering INTERNATIONAL 2013
Index / Masthead
Advertisers / Index
Advertisers
apra-plast KunststoffgehäuseSysteme GmbH, Daun-Pützborn 15
Bicker Elektronik GmbH,
Donauwörth
37
Bühler Motor GmbH,
Nürnberg
21
CIM med GmbH, München
19
Comité EPMT/EPMT
9
EBV Elektronik GmbH, Poing
2
Faulhaber GmbH & Co.KG, Dr. Fritz,
Schönaich
60
Gardner Denver Thomas GmbH,
Puchheim
47
Hanser Verlag, München
59
Helmut Klingel GmbH,
Pforzheim
27
KNF Neuberger GmbH,
Freiburg
29
Kontron Embedded Modules GmbH,
Deggendorf
45
Maxon Motor AG,
Sachseln/CH
front cover
Micro-Epsilon, Ortenburg
5
MSC Vertriebs GmbH,
Neufahrn
3
Novoplast GmbH, Halberstadt
41
Opto Sonderbedarf GmbH,
Gräfelfing
49
Panasonic Electric Works Europe
AG, Holzkirchen
11, 31
Physik Instrumente
GmbH & Co.KG, Karlsruhe
7
RECOM Elecrtonic GmbH,
Neu-Isenburg
57
Schleifring und Apparatebau
GmbH, Fürstenfeldbruck
47
Stemmer Imaging GmbH, Puchheim
51
Steute Schaltgeräte GmbH &
Co. KG, Löhne between page 34+35
STM Sensor Technologie München
GmbH, Neubiberg
13
Index
A. Hopf
Awaiba
Baumer Group
Bayer HealthCare
Biofluidix
C IM med
Colder Products
COMPAMED
Compumedics DWL
congatec
dSPACE
Eastman Chemical
Edmund Optics
Electronic Assembly
ELTRA
Fischer Connectors
Fraunhofer IOF
46
8
29
7
22
40
54
8
35
27
43
46
51
26
18
40
8
Fraunhofer IZM
Fujitsu Technology
Gsell Medical Plastics
Helix Medical
HOERBIGER Micro Fluid
ITT Cannon
KNF Neuberger
Leoni
LINAK
Maquet
maxon motor
MEDICA
Messe Düsseldorf
Micro-Epsilon
MSC Vertriebs GmbH
NuSil Technology
Ottobock
Pantec Engineering
Parker Hannifin
PEWATRON
Physik Instrumente (PI)
Proto Labs
Protomold
Radimetrics
Reichelt Chemietechnik
Richard Wolf
Sensirion
SKF
Sony DADC
Steinbeis Transfer Centre for
Plastics
8
35
53
50
40
26
40
41
19
11
39
8
8
17
30
46
38
34
19
18
23
25
25
7
46
11
18
18
6
6
steute Schaltgeräte
Swiss Medical Cluster
Texas Instruments (TI)
TQ-Systems
TTP
Vistamed
Watlow
World Medtech Forum
Zellwerk
13
6
31
37
26
50
6
6
24
Authors
Arnold Steffen
Becker Guido
Cabell Peter
Callenbach Tilo
Diepenbrock Stefan
Eisenbarth Wolfgang
Fässler Patrick
Gerold Widenhorn
Hoffmeister Hans
Hoser Peter
Huber Lorenzo
Krob Doreen
Lillwitz Sonja
Löffler Thomas
Maher Linda
Mausolf Rainer
Mohr Ingo
Salzberger Johann
Schuetz Anja
23
15
37
53
29
32
53
35
24
35
34
45
45
25
50
24
56
17
39
Masthead
Short description
MED engineering is the trade journal for
designers and developers of diagnosis
and therapeutical devices for all medical
fields, including ophthalmology, ENT and
dental medicine as well as for laboratory
diagnostics and OR technology. It provides valuable information in order to
export medical devices. The topics focused on are medical electronics, hardware and software device components as
well as materials, relevant for the device
development as well as the development
of endo- and exo-prostheses. Information
on metrology and software tools support
the developers in their daily work.
Editor-in-Chief
Erika Fuchs
Kolbergerstraße 22,
81679 München / Germany
Phone +49 89 99830-626
Gabriele Wieser (Assistant)
Phone +49 89 99830-231
Fax +49 89 99830-126
Advisory Board
Rainer Birkenbach, BrainLAB;
Prof. Dr. Armin Bolz, Corscience;
Kurt Eggmann, Weidmann Plastics;
MED engineering INTERNATIONAL 2013
Prof. Dr.-Ing. Petra Friedrich, University in
Kempten, Germany;
Theodor Lutze, Aesculap;
Prof. Dr. Peter Schaff, TÜV SÜD;
Dr. Timo Schirmer, GE Healthcare;
Sigrid Uhlemann, DQS Medizinprodukte;
Prof. Dr. Dr. Erich Wintermantel, University
in Munich (TUM), Germany
Publisher
Carl Hanser Verlag GmbH & Co. KG
Kolbergerstraße 22, 81679 München
Postfach 86 04 20
D-81631 München / Germany
Phone +49 89 998300
Fax +49 89 9848-09
www.hanser.de, ISSN 2190-8788
www.med-eng.de
In accordance with §8 of the Bavarian Press
Act, we herewith state the ownership structure as follows: Carl Hanser Verlag GmbH &
Co. KG, Kolbergerstr. 22, D-81679 Munich,
seat and registry court: Munich HRA 49621,
Shareholders: Carl Hanser
Verlagsleitungsges. mbH, Kolbergerstr. 22,
D-81679 Munich, seat and registry court:
Munich HRB 40463; Ruth Beisler, housewife, Munich; Gertraud Bracker, book seller,
Weilheim; Wolfgang Beisler, managing
director, Munich; Ulrike Beisler, publisher,
Rome; Christoph Beisler, artist, Munich.
Managing Directors
Wolfgang Beisler, Stephan D. Joß,
Michael Krüger
Advertisement Manager
Martin Ricchiuti
Phone +49 (0)89 99830-686
Fax +49 89 99830-623
martin.ricchiuti@hanser.de
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Phone +49 89 99830-420
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58
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The use of general descriptive names,
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While the advice and information in this
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© Carl Hanser Verlag, München 2013
© Carl Hanser Verlag, Munich
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