Medical Devices - MED engineering

Transcription

2014
w w w . m e d - e n g . d e/i n t e r n a t i o n a l
12Titlestory
Robotic exoskeleton
improves patients’ life
34Embedded
With customizing to
individual products
46Implants
Polymer-based
load-bearing implants
HIGH-PRECISION LEADER
WATCHMAKING AND JEWELLERY - MICROTECHNOLOGIES – MEDTECH
Note of the Editor
W
elcome to the third edition of MED International which is
an annually published English version of the German
magazine MED engineering. It is supposed to be a shopwindow for developers and designers of medical and laboratory devices. Of course, it cannot be complete because there are many excellent Austrian, German and Swiss suppliers who deliver high performing and reliable components. Nevertheless, this edition mirrors
an important trend in medtech industry: Many products described
in this edition are lightweights and I am not telling a secret when I
say most of them are smaller than their predecessors. Apart from
this, power consumption of many components has been reduced
significantly.
Lean development
with competent
partners
Reducing weight, size and power consumption is important to remain competitive. In addition to this, medical device manufacturers
want to shorten time-to-market and reduce development costs. As
product development eats up a big share of the expenses needed to
create a new product, the developing process bears a great potential
to save time and money. In other words, after lean production follows lean development. Partners can be very helpful here. Lean development requires a clear development strategy (page 28) and
product modularization. Both make it much easier to work with experienced outsourcing partners (page 14) in order to keep ambitious
time schedules. Making use of standards is another way to save time.
Especially computer technology is changing fast. Using the most recent standard embedded platform (page 34) does not only help to
keep pace with the rapidly changing world of processors, it also allows focusing on core competencies.
precise
sensors for
exact position
Draw wire sensors are often used in
medical equipment because of their
simple measuring principle and easy
handling.
 Examples of successful application:
X-ray machines, operating table, assistance
robot, computer tomography etc.
 Large sensor range for all requirements
 Customised OEM sensors possible
I hope you enjoy reading this edition and find many helpful suggestions for your work. Best regards,
Erika Fuchs, Editor in Chief
[email protected]
3
www.micro-epsilon.com
MICRO-EPSILON | 94496 Ortenburg / Germany
Tel. +49 85 42/168-0 | [email protected]
Contents Intuitive Control Via Touch
Screen
This 42-inch touch screen with
drag & drop functionalities gives
physicians quick and easy access
to patient-related image data. An
ATX board makes this possible. It
delivers the computing power required during video processing.
42
Contact:
Editor-in-Chief
Erika Fuchs
Tel. +49 89 99830-626
Assistant
Kerstin Gottscheber
Tel. +49 89 99830-231
Advertisement Manager
Martin Ricchiuti
Tel. +49 89 99830-686
Publisher
Carl Hanser Verlag GmbH & CO. KG
Kolbergerstraße 22
81679 München/Germany
www.med-eng.de
E-Mail: [email protected]
Fax +49 89 99830-126
Defining the Art of Silicone
Antimicrobial materials, miniature multi-lumen tubing, catheters and surface modifications
– silicones and thermoplastics
can be uniquely customized. Dr.
Max Kley of Helix Medical Europe
explains the art of customizing
these materials.
52
Advisory Board:
Driving Force of 3D-Visua
lization
Rainer Birkenbach, BrainLAB;
Prof. Dr. Armin Bolz,
Corscience;
Kurt Eggmann,
Weidmann Plastics;
Prof. Dr.-Ing. Petra Friedrich,
University, Kempten;
Dr. Martin Leonhard,
KARL STORZ;
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)
MEDengineering INTERNATIONAL 2014
Customized drives bring two
objectives of a laparoscope
into position in order to get 3D
images. These images make the
minimal invasive intervention
more precise and result in minimal traumata.
22
4
© Carl Hanser Verlag, München
MED Devices
12 Robotic Exoskeleton
Innovative robotic technology
equipped with DC motors ensure
smooth limb movement
14 Fast Forward to
a Proof of Concept
How to get the first samples of a
customized microdrive in less
than 15 weeks
16 Microdrives Control
Magnetic Stimulation
Thanks to microdrives, transcranial magnetic stimulation is working
automatically
19 New Products
Linear card motor;
Fans and modular drives
20 Position Measurement
in X-Ray Devices
Draw wire sensors measure the
height of the X-ray tube and detect the vertical table position
25 New Products
Batteries for active implants;
High voltage power supply
26 Facilitating Daily Work at the
Hospital
Carrier systems are supposed to
optimize processes by sophisticated ergonomical solutions
28 Successful With
Outsourcing Partners
The approval process often appears to be an obstacle but there is
always a better way
32 New Products
Fluid-isolation valve;
Rocker valve;
Gas diaphragm pump
50 New Products
Micro camera;
Customizable audio receiver;
Vacuum pump;
DC/DC converter
>>> f a s t f o r w a r d s o l u t i o n s
MED Electronics
34 Customized Medical Computers
ODM services overcome technology barrieres and accelerate the
way to individual products
38 Controlling Large Displays
Diagnostic systems with large
high resolution displays need
high-end processor technology
MED Prostheses
5
ISO 1348
Certified
46Polymer-Based
Load Bearing Implants
Plastic implants allow to observe
the healing process without X-ray
shadows
48 Sawing Titanium –
the Ultimate Challenge
A high-performance circular saw
guarantees optimum results in
terms of economy, precision, and
operator's safety when working
with titanium
Materials
56 One Tube is Not Like Another
Inner and outer diameter is not all
you need in order to define a tube
Service
03
06 10 58 Note of the editor
Medtech News
Medtech Events
Masthead/Index
Customized drive solutions
3 Near Patient Device
3 Electronically Enabled Drug Delivery
(EEDD)
3 Infusion and Medication
3 Ambient Assisted Living
Titlepage Advertising
Ten powerful motors for safe movements
A company based in Auckland (New Zealand) has developed innovative
robotic technology that helps people with mobility impairment get back on
their feet: the robotic exoskeleton from Rex Bionics. The DC motors from
maxon motor ensure smooth limb movement.
maxon motor ag
Brünigstrasse 220
6072 Sachseln / Switzerland
Tel: +41 (41) 666 15 00
Fax: +41 (41) 666 16 50
[email protected]
www.maxonmotor.com
www.buehlermotor.de
2014
w w w . m e d - e n g . d e/i n t e r n a t i o n a l
We look forward to
seeing you at:
Pharmapack Europe
in Paris
12 Titlestory
34 Embedded
Robotic exosceleton
improves patients life
5
Customizing shortens
time to market
46 Implants
Polymer-based loadbearing implants
Porte De Versailles
Booth No. 843
12.02. - 13.02.2014
Bühler Motor GmbH
Postfach 450155
90212 Nuremberg
Germany
Tel.: +49(0)911 / 45 04 - 0
Fax: +49(0)911 / 45 46 26
[email protected]
Medtech News
Home Monitoring
The REFORM study demonstrates that ICD (implantable cardioverter-defibrillator) patients with BIOTRONIK’s Home Monitoring enjoy a reduction in follow-up visits by 58 per cent. This
in turn leads to patients reporting enhanced quality of life.
According to Prof. Gerhard Hindricks, MD, Heart Center, University Leipzig, Germany, the number of patients with an ICD
is rapidly increasing, and the burden of frequent, necessary
follow-ups falls on patients, physicians and hospitals. The
study shows a reduction in follow-up visits with Home Monitoring, and is the first trial to indicate that longer intervals
between follow-ups contribute to an improved quality of life.
REFORM is a prospective, international, multi-center, randomized study investigating the effects of standard three- and
twelf-month follow-up schemes. 155 ICD patients with
MADIT-II indications were randomized into two groups. Both
received remote follow up via Home Monitoring with fully
automated daily data transmission and physician alerts of
clinically relevant events. Compared to the group receiving
quarterly follow-ups, the number of visits per patient per year
could be reduced in the group with yearly follow-ups from
3.85 to 1.60, whicht means by 58 per cent. »The study demonstrates that, one-year intervals between follow-up visits in
Figure: BIOTRONIK SE & Co. KG
Study proofs reduction of follow-up visits
Home monitoring devices improve ICD patients’ life because one-year
intervals between follow-up visits are sufficient
primary prevention ICD patients do not compromise safety in
any way. Again, this leads to enhanced patient quality of life,
as patients feel less ill and less distracted from normal life, in
addition, it reduces the workload for physicians. On the
strength of remote monitoring information, they can decide if
a follow-up is necessary,« explains Prof. Hindricks, adding that
in many cases, an in-office follow-up is not needed at all.
The REFORM study’s findings are in agreement with results
from other trials like the landmark trial TRUST which showed a
45 per cent reduction of in-office follow-ups and earlier detection of clinically relevant events.
www.biotronik.com
Office1 Instead of Operation Theatre
KARL STORZ GMBH & Co. KG
Outpatient treatment saves time, money and patient’s nervs
The Health Foundation’s annual SHINE programme in UK
funds ideas that focus on new innovations. Richard Penketh,
Consultant Obstetrician and Gynaecologist at the University
Hospital of Wales,
proposed to develop a way to
move hysteroscopic gynaecological procedures
from theatre to
outpatients,
streamlining the
entire operating
process. Local
anaesthetic use
had already increased, but evaluOutpatient treatment in OFFICE1 keeps the
main theatre free for major surgery
ation identified that
patients often
found it intimidating to be awake in a theatre environment.
The move to outpatients allowed to establish an operating
space that looked more like a consultation room, is smaller,
less formal, and requires fewer staff. This helps to create a
quicker, less nerve-wracking episode for patients, while freeing the main theatre for major surgery. With the SHINE team
working in collaboration with KARL STORZ, the OFFICE1 workspace became a central part of the new initiative. The first
OFFICE1 in conjunction with ENT clinicians for an office environment, the OFFICE1 at UHW is the first to be used for gynaecological procedures. The workspace is fully functional, and
has integrated picture documentation at the push of a button,
so also acts as a patient documentation centre that can be
easily integrated into hospital information systems. Real time
HD endoscopic images can be played via the various HD monitors positioned around the suite, and watched by the patient
and team. Alternatively, with the incorporation of an iPod
docking station, during the procedure the patient can watch a
movie on the large wall-mounted 40” HD screen or listen to
music. Since the launch of the facility, routine waiting times
for hysteroscopic resection have more than halved from 26
weeks to eight to twelve weeks, and cases of suspected cancer are seen within three to six weeks. The entire process has
been streamlined and costs £651 pounds less than a day case
procedure carried out under a general anaesthetic. This figure
is based on performing an endometrial resection within the
UHW SHINE project.
www.karlstorz.com
6
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EBV’s linecard strategy alone distinguishes the company from its
competitors. Instead of offering a vendor’s tray of suppliers, the
formula here is to focus on a selection of technologically leading
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Our Partners for Your Success
And because EBV only selects the very best manufacturers, our people
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www.ebv.com/linecard and www.ebv.com/products.
Distribution is today. Tomorrow is EBV!
www.ebv.com
Medtech News
Dr. Harald Stallforth retired. At the end of the year 2013 the management
board of Aesculap in Tuttlingen, Germany has changed. After more than 30
years of service with Aesculap, a company of the B. Braun group, Dr. Harald
Stallforth (see figure), Deputy Chairman of the Board and person responsible
for the areas of ›Research & Development‹ and ›Quality Management‹ retired
at the end of 2013. During his long-standing time at the company, Dr. Harald
Stallforth, engineer and legal expert, has played a key role in shaping the
development of Aesculap, in particular in the area of ›Research & Development‹. One of his many contributions was the development of the ›Aesculap
Innovation Management (AIM)‹, a project management method to promote a
competitively viable culture of innovation at the company. He also helped
build and expand the Research and Development department, starting with
25 employees in the early days to its current size of 300 employees. Dr. Dirk
Freund took over from Dr. Stallforth on January 1, 2014. Before his time at
Aesculap, Dr. Freund, who graduated as an electro-technician, held a number
of positions within the R&D department of Procter & Gamble.
www.aesculap.com
Figure: Aesculap, Tuttlingen
Aesculap’s Board changed
Dr. Harald Stallforth retired after 30 years. He played a key role in
shaping the R&D department of Aesculap
European Commission is Boosting Innovation
Biggest EU research programm ever
The European Commission adopted ›Horizon 2020‹, the next
EU research and innovation programme. With a budget of
about EUR 70 billion euro over seven years, Horizon 2020 is
the biggest EU research programme yet, and one of the
Industrial Leadership
biggest publicly funded worldEUR 17.0 billion
wide. It is a totally new type of
research programme for the EU
that has been designed to deliver results that make a difference to people’s lives. Built on
three pillars − Excellent Science,
Industrial Leadership and Societal Challenges − it will fund all
Excellent Science
types of activities, from frontier
EUR 24.4 billion
science to close-to-market innoSource:
EU
Commision
vation. The programme for the
first time brings all EU-level
funding for research and innovation under one roof, provides
a single set of rules and will radically slash red tape. The overarching goal is a more coherent, simpler programme that will
make it easier to participate, especially for smaller research
organisations and small businesses.
Horizon 2020 replaces the ›Seventh Framework Programme
for Research‹ (FP7). Some key elements of Horizon 2020 are
for example:
Increased funding for the European Research Council, already
one of the world’s premier frontier-research funding agencies; Innovative public-private partnerships in areas such as
new medicines, greener aircraft technologies and electronics;
Investment in Key Enabling Technologies (KETs) such as photonics, nanotechnologies and biotechnology; A challengebased approach to key issues facing societies, such as health-
Societal Challenges
EUR 29.7 billion
European Institute of
Innovation and Technology
EUR 2.7 Billion
About 70 billion euro
spends the EU commision to boost
innovation in Europe
Other
EUR 3.2 billion
Euratom
EUR 1.6 billion
© MEDengineering
care, sustainable agriculture, smarter and greener transport,
and climate change; A renewed focus on widening participation in less well-performing EU countries, including better
synergies with European Structural and Investment Funds; A
dedicated SME Instrument, and a ›Fast Track to Innovation‹
pilot scheme to speed up the time from idea to market, and to
increase the participation of industry, SMEs and first time
applicants in Horizon 2020;
A programme for ›Science for and with society‹, in order to
engage European society, increase the attractiveness of
science careers and address gender imbalance in the field.
http://ec.europa.eu/research/horizon2020/index_en.cfm
8
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Medtech Calender 2014
MedTech Events
Arab Health
International exhibition and
conference
www.arabhealthonline.com
January 27 – 30, 2014
Dubai, United Arab Emirates
IS&T/SPIE
Electronic Imaging
International forum for
digital imaging systems
www.spie.org/x16218.xml
February 2 – 6, 2014
San Francisco, USA
MD&M West
International trade fair for
manufacturers of medical
devices
www.canontradeshows.
com/expo/west14
February 11 – 13, 2014
Anaheim, USA
CMEF Spring 2014
RSNA
International fair about
medical equipment
www.cmef.com.cn/
en/index.html
April 17 – 20, 2014
Shenzen, China
Annual Meeting of the
Radiological Society of
North America
www.rsna.org
Nov. 30 – Dec. 5, 2014
Chicago, USA
MEDTEC France
Rapid.Tech
European medical device
manufacturing industry,
trade fair
www.medtecfrance.com
April 9 – 10, 2014
Lyon, France
Trade fair and users
conference for rapid
technologies
www.rapidtech.de
May 14 – 15, 2014
Erfurt, Germany
MEDTEC Japan
Trade fair with focus on the
healthcare industry
www.medtecjapan.com/en
April 9 – 11, 2014
Tokyo, Japan
Medica
World forum for medicine
www.medica-tradefair.com
November 12 – 15, 2014
Dusseldorf, Germany
MEDTEC UK
trade fair
www.medtecukshow.com
May 14 – 15, 2014
London, UK
Compamed
International trade fair –
high tech solutions for
medical technology
www.compamedtradefair.com
November 12 – 14, 2014
Dusseldorf, Germany
SPIE Medical
Imaging
International forum
for medical imaging
www.spie.org/mi14
February 15 – 20, 2014
San Diego, USA
Med-e-tel
International eHealth,
telemedicine and health ICT
forum for education,
networking and business
www.medetel.eu
April 9 – 11, 2014
Luxembourg, Luxembourg
Embedded World
China Med
International exhibition
and conference
www.embedded-world.
de/en
February 25 – 27, 2014
Nuremberg, Germany
International exhibition for
medical instruments and
equipment
www.chinamed.net.cn/en
March 21 – 23, 2014
Beijing, China
Electronica China
Orthotec Europe
electronic components,
systems and applications
www.electronicachina.com
March 18 – 20, 2014
Shanghai, China
European orthopaedic
design and manufacturing
conference and exhibition
www.orthoteceu.com
March 19 – 20, 2014
Zurich, Switzerland
MEDTEC Europe
Electronica 2014
trade fair
www.medteceurope.com
June 3 – 5, 2014
Stuttgart, Germany
electronic components,
systems and applications
www.electronica.de
November 11 – 14, 2014
Munich, Germany
MD&M East
Trade fair for manufacturers
of medical devices
www.canontradeshows.
com/expo/east13/
index.html
June 10 – 12, 2014
New York, USA
SMT – Swiss Medical
Technologies
Meetingplace for Medtech
www.ephj.ch
June 17 – 20, 2014
Geneva, Switzerland
10
AdvaMed Conference
International MedTech
conference
www.advamed2014.com
October 6 – 8, 2014
Chicago, USA
MEDTEC China
Trade fair for medical
device manufacturing
industry
www.medtecchina.com
September 25 – 26, 2014
Shanghai, China
… with Thomas Pumps for Medical Applications
Gardner Denver
Thomas GmbH
Medical dream machines that are able to fulfill a complete range of technical
demands in one device are pure fantasy. But even today, in the world of medical technology, our pumps are already turning a multitude of designer and
developer visions into reality.
Benzstraße 28
D-82178 Puchheim
We get ideas going.
www.gd-thomas.com
Fon: +49 89 80900-0
Fax: +49 89 808368
Medical Devices DC Motors
Worldwide an estimated 185 million people use a wheelchair
daily. Innovative robotic technology helps them now to get
back on their feet. DC motors ensure smooth limb movement.
Robotic Exoskeleton: For
More Quality of Life
H
ayden Allen is a young man from New Zealand. He has
been restricted to a wheelchair ever since a motorcycle
accident damaged his spinal cord. The doctors told
him that he would never walk again. Hayden is one of the first
users of the Rex robotic exoskeleton. The first time he t ested
his robotic legs, his friends told him that he should stop looking at this feet. »I simply could not stop staring at my feet
moving,« says Hayden as he describes his first steps with Rex.
The robotic legs gave him back quality of life and new per
spectives. Locations that were previously completely inaccessible were now within reach again. In his profession as a mechanic, he is now able to perform tasks that require him to
stand up, and many new opportunities are available to him in
his leisure time.
Contact
maxon motor ag
CH-6072 Sachseln
Phone +41 (0)41 666-1500
Fax
+41 (0)41 666-1650
www.maxonmotor.com
1 The founders of
Rex Bionics: Richard
Little (left) and
Robert Irving developed this type of
robotic leg
12
the basic requirements was that the user, with his restricted
physical abilities, has to perfectly harmonize with the externally mounted robotic legs and can fully safely stand and walk.
2 Rex is a highly complex electromechanical device. Each exoskeleton has thousands of precision parts
Figure 1+2: Rex Bionics Ltd., Figure 3: maxon motor ag
Around nine years ago, the two founders of Rex Bionics,
Richard Little and Robert Irving (Figure 1), had the idea of developing this kind of robotic legs. The reasons were obvious:
Robert Irving had already been diagnosed with multiple sclerosis and he knew he would end up in a wheelchair sooner or
later. Both of the developers’ mothers are in wheelchairs,
thus they knew very well what great obstacles are
faced by wheelchair users. The two friends
decided to use their know-how as engineers to develop a machine for people
who would usually require a wheelchair
to move about. This was the start of
the New Zealand-based company.
The exoskeleton weighs 84 pounds, but the user does not carry any of this weight. It is operated by means of an integrated,
exchangeable battery that lasts around two hours of continuous operation. Rex is controlled with a joystick and control pad
– other exoskeletons frequently use sensors. A large advantage of the joystick operation is that no movement or nerve
functions are required to use the exoskeleton. At approximately three metres per minute, the Rex is not very fast, but the
user can move forward very safely. They won’t lose balance –
because, regardless of whether it is switched on or off, the exoskeleton always remains stable. The user can also stand in a
crowded environment, like a sports event or a concert, without
worrying about being pushed over. Rex also does not require
the use of supporting aids such as crutches, which means that
the user has full use of his arms and hands.
Rex is a highly complex electromechanical
device (Figure 2) – each exoskeleton
has thousands of precision parts, including the limbs that are controlled
by a network of 29 microcontrollers. The
special arrangement of microcontrollers
in Rex makes it possible to move and
react within seconds. The movements
performed by Rex always feel smooth
to the user. DC motors are responsible
Exoskeletons have been developed to help peofor ensuring no jerky movements oc3 Ten DC RE 40 motors per exoskelple with mobility impairment to walk. This imcur. They control all movements of the
eton ensure smooth movements
proves their strength and endurance. Rex gives
limbs that move in the same way as a
these people the ability to stand, walk, get up, turn around and
human leg. Ten RE 40 DC motors (Figure 3) are used in each
sit down on their own again. Moving
exoskeleton. The RE 40 is equipped with powerful 150 W and has
Secure hold sideways, taking the stairs or walking an efficiency of more than 90 percent. The mechanically comon standing on hard, flat surfaces with slopes also mutated DC motors are characterized by good torque behavpresents no problems. Even though
iour, high dynamics, a very large speed range and a long service
the bionic legs cannot fully replace the wheelchair, the user is
life. The heart of the motor is the globally patented ironless rotor
once again able to perform tasks standing up. Even just being
that ensures detent-free running of the drive.
able to be on the same eye level in conversation is an unbelievable experience for these people. »We want to reach as many
Rex Bionics chose to use the high-quality maxon motors for a
people as possible in the world by using perfected technology
good reason: Rex is a highly sensitive medical product and the
and continuous improvements in functionality, form and
safety of the users is of utmost importance. The largest chalusability. When we see the unbelievable emotional reactions of
lenge, where the motors are concerned, was uniting quality,
Rex users, every day brings us joy and that motivates the entire
size and power in a single product. Currently Rex is being used
Rex team,« says co-founder Richard Little.
by approximately 18 people in New Zealand, with new users
joining this group every month. They can all share the feelings
Today Rex Bionics has two manufacturing facilities where they
of Mitch Brogan: »My cheeks were aching from my constant
produce two different Rex versions for different needs: Rehab
smiling and I knew that my life has changed forever.« Rex is intended for use in rehabilitation centres. Rex has been
developed for private users that can now perform tasks that
are not possible when sitting in a wheelchair. According to
Richard Little, the largest challenge during the development
Anja Schütz
process was the development of the very complex robotic
is editor at maxon motor.
platform, which also had to be very light. Furthermore one of
[email protected]
13
Medical Devices Microdrive
Fast Forward
to a Proof of Concept
Reducing time to market and
cost during the development
process of an innovative drug
dosing and dispensing system
was important in order to
maintain advantages in competition. Although the whole
task is a challenge, the first
samples were delivered in less
than 15 weeks.
O
n the way from the idea to the finished product, the
Proof of Concept is an important milestone, the moment of truth, as it were. Only the Proof of Concept
permits you to make fundamental decisions. No wonder, that
any developer will want to − indeed, have to − get to the Proof
of Concept as fast as possible. And the recent development of
a microdrive for a medical device demonstrated what the
Bühler engineers were able to achieve.
Contact
Bühler Motor GmbH
D-90459 Nürnberg
Phone +49 (0)911 45040
Fax +49 (0)911 454626
www.buehlermotor.de
14
Figure: Bühler Motor GmbH
1 This planet carrier has a diameter of only
5.5 mm. It is a part of a planetary gear box with
three stages and an outer diameter of 7 mm
The task was a drive solution for the control of the flow and its
quantity in a drug-dispensing system with an accurate repeatability. Since the system is a patient-side system, available
space was a decisive factor from the very beginning. To put it
differently: the engineers were looking for a compact microdrive. Patient-side also means a low-noise design. Additionally
the drive was also supposed to be produced in large numbers
at low costs. But there was a special challenge: The costumer
wanted to have functional samples at his disposal within only
15 weeks.
Piezo Solutions
FOR MEDICAL ENGINEERING
The solution in this case was a gear motor consisting of a
three-stage planetary gear with a diameter of only 7 mm and
a brushless motor combined with a matching encoder. The
valve flap was directly actuated by a spindle drive that translates the rotary motion into a linear one. Given the very high
specified service-life expectation, the engineers opted for a
brushless motor. The three-stage planetary gear with a gear
reduction of 250:1 provides the right torque. In combination
with the high-resolution encoder an extreme repeat accuracy
is guaranteed.
Piezomotor Stages
Compact design
Velocities of up to
400 mm/s
Sub-micrometer resolution
So far, so good. But now it was about the realization of functional samples in a very short period of time. ›Functional‹
here means that these samples have to be in line, more or
less, with the later large-scale production parts. The basic
functionality is verified in the medical product developed by
the customer.
Piezo Tip/Tilt Mirrors
Optical deflection area of
up to 120 mrad
Position resolutions in the
nanoradian range
Fast response behavior:
10 ms to 1 ms with mirror
This was a strenuous effort. But the project was realized by the
smooth and simultaneous collaboration of various teams and a
close cooperation with competent partners. For the planet
gear wheels of only a few millimeters in size, injection-molding
tools were necessary to attain the utmost precision. After thorough checks, conventional procedures to manufacture samples like machining, laser or 3D prints were found to be unsuitable. Therefore tools were inevitable. Really helpful was that
most of the tasks were done out of one hand.
PiezoMove®
Piezo Actuators
Travel ranges to 1 mm
Sub-nanometer resolution
High dynamics
This lead to high speed and flexibility. Bühler Motor has its own
facilities for endurance tests, audible noise tests, tests under
climate conditions and last but not least the EMC test. All necessary changes and adaptations were realized without any detours by the close cooperating of development, prototyping,
metrology and testing departments.
Piezo systems from PI are particularly suited for the
most challenging applications in medical technology,
microscopy, biotechnology or life science. They are fast,
reliable and compact.
For more information contact us: [email protected]
Physik Instrumente (PI) GmbH & Co. KG · Tel. +49 721 4846-0
The real challenge nevertheless was the ambitious time frame.
All the means mentioned before enabled the team to realize
30 functional samples that had been asked for in less than
15 weeks.
PIEZO
NANO
POSITIONING
W W W. P I - M E D I C A L . W S
pi_130920_medical_85x250_en.indd 1
15
27.11.13 09:56
Medical Devices Microdrives
Transcranial magnetic stimulation can stimulate or inhibit areas
of the cerebral cortex. Thanks to microdrives, this new technology has been automated and integrated in a compact housing.
Microdrives Control Magnetic Stimulation
N
ot only is Transcranial Magnetic Stimulation (TMS) a
useful tool in neuroscientific research, it is also used in
the diagnosis and treatment of neurological and psychological illnesses, particularly with depression. With this
technology, a strong magnetic field is produced in the cerebral
cortex. This magnetic field can be used to stimulate or inhibit
the electrical activity of the neurons. The coil that produces
the focussed magnetic field must be exactly and reproducibly
positioned and directed at the correct points in the brain.
With this in mind, the French company Axilum Robotix, together with their partner Streb & Weil, developed the world’s
first robotic assistant specifically for TMS (Figure 1). The system positions the TMS coil very precisely and safely on parts
of the brain which are specifically defined for each patient in
Contact
1 The Axilum robot directs the magnetic field precisely and reproducibly so that it is concentrated on the point that is to be stimulated.
The patient sits in a comfortable, electrically adjustable chair with head rest
16
Figures 1,2 + 3: Axilum Robotix
Dr. Fritz Faulhaber GmbH &Co. KG
D-71101 Schönaich
Phone +49 (0)7031 6380
Fax +49 (0)7031 638-100
www.faulhaber.com
2 The hemispherical
structure of the robot
arm with seven axes
guarantees good access
Figure 4: Dr. Fritz Faulhaber GmbH & Co. KG
advance. With the goal of producing a compact and precise
device, the developers worked together with the microdrive
specialists FAULHABER to create a drive which can achieve
highly reproducible positioning through the integration of
zero backlash gearheads in the guide arm for the coil.
The first transcranial magnetic stimulations (TMS) were performed by doctor and physicist Jacques-Arsène d’Arsonval at
the end of the 19th century at the Collège de France in Paris. At
the University of Sheffield, Anthony Barker worked on the
modern version of the TMS in 1985. Considerably smaller coils
that stimulate only a small region of the cerebral cortex improved the results. Magnetic stimulation of the part of the cortex located near the cranium is today performed with nearly no
discomfort for the test subjects or patients. However, the small
coils require highly precise positioning of the magnetic field
source. The principle is simple: a TMS coil, which is connected
to a stimulator, is positioned tangentially on the cranium and
delivers a magnetic field with a strength of up to 3 tesla for a
few milliseconds. The resulting change in electrical potential in
the part of the cortex located near the cranium causes a depolarisation of neurons and the triggering of action potentials.
The strength of this electric field decreases exponentially with
distance to the coil. This decrease is another reason for placing
the coil as close as possible to the brain area that is to be stimulated, for example, in direct contact with the cranium, without
reducing the precision of the positioning.
Starting from these requirements, the
experts from France developed a robot that can very precisely and reproducibly position the TMS coil around
the head of the test subject. The patient sits in a comfortable, electrically
adjustable chair with head rest to minimise head movements. The robot is
controlled by a neuronavigation system, whereby an optical monitoring
system is used to detect and compensate for any head movements. The
coil is equipped with a contact sensor
and can thereby be safely brought
into contact with the cranium.
The hemispherical structure of the robot arm with seven axes guarantees
good accessibility (Figure 2). The
gearheads and drives are located as
close as possible to the axes. The power regulators are also placed very close
to the drives to ensure the shortest
possible connection to motor and encoder. The power regulators are
equipped with shared power supply
and bus connection for communi-
Compact robot
guides the coil
»
17
Medical Devices Microdrives
»
cation with the control and operating system (central processing unit
with processor). In addition, the control and operating system performs
safety management for, among other
things, emergency stopping as well as
all primary control tasks, such as the
calculation of the kinematics of the robot arm, position control with the help
of the contact sensor (Figure 3).
High EMC
requirements
Due to technical and medical restrictions, the gear motors and their actuators must meet special requirements. The pulsed magnetic fields,
which are emitted by the TMS coil, require very high EMC immunity (EMC:
electromagnetic compatibility) at the
height of the robot arm. The electronic unit generally produces only very
low emissions in order to keep from
interfering with nearby medical devices. The lines must therefore be as
short as possible and be shielded to
eliminate data errors caused by the
therapeutic magnetic fields. Shielding
of the cables is also important, as they
will otherwise act as antennas and can
interfere with other devices. To quickly compensate for head movements,
4 Microdrives enable
precise positioning
with very compact
design
the motors must have a high starting
torque and yet not overheat. Encoders with high resolution and gearheads with reduced backlash ensure
precise positioning.
3 The control and operating system performs the safety management and communicates with the compatible neuronavigators via
Ethernet
tor and planetary gearhead of appropriate diameter. The small,
four-pole motor delivers about 9 W and its encoder generates
1024 pulses per revolution, thereby yielding a resolution of
4096 points per revolution. Together with the reduction of the
three-stage, all-steel gearhead of 86:1, this results in a very
high resolution of the rotary movement and enables highly
precise coil positioning (Figure 4). The six larger motors deliver 33 or 210 W at the output shaft and are also equipped with
high-resolution encoders. Pretensioned, maintenance-free
ball bearings ensure a long, backlash-free operating life. In addition to the special requirements of the TMS with regard to
safety and compliance with standards, the drives satisfy all
conditions for use in the medical sector.
To optimally match the drives to the special conditions, the engineers from Axilum worked closely together with the specialists from Schönaich. As a result, they were together able to
quickly clarify questions regarding electromagnetic compatibility, cable lengths and shielding and integrate special plug
connectors. This approach accelerated the development and
testing of the TMS robot without needing to make compromises in safety or reliability.
In practice, the robot specialists use
various brushless motors in the arm.
These motors are dimensioned so
that they can deliver the required
torque and still be as small as possible. Consequentially, two 44 mm motors and four 32 mm motors are
housed in the robot arm. There is also
a 22 mm gear motor consisting of mo-
Dipl.-Ing. (FH) Andreas Seegen
is head of Marketing at FAULHABER.
Dipl.-Chem. Andreas Zeiff
is employee at the editorial office Stutensee.
18
Linear Card Motor
Compact, lightweight and powerful. The card motors from SMC’s LAT3 series move and position loads
precisely and quickly – with up to 500 cycles per minute. The linear motors in the new series – which are
the size of an EC card – are used in positioning, pushing and measuring applications, such as in medical
technology, biotechnology or analytical technology. The card motors, with a height of 9 mm and a weight
of 130 g, move loads either horizontally from 50 g to 500 g or vertically
up to 100 g with a maximum speed of
400 mm/s. Their thrust is 1 to 5 N – in
pushing applications where predefined forces are exerted on an
object, this reaches 6 N. The series
transports and positions loads
precisely, with a repeatability of
±5 µm. The linear motors work
quietly with a high operating frequency of up to 500 cycles per
minute. The series combines a linear
motor, a linear guide and a path
measuring system. It can be installed quickly without bothersome edges because the cable connector
does not protrude above the drive. Using the LATC-W1 software and the suitable SMC LATC4 controller, the
motors can be easily programmed by entering the target position, positioning time and payload. Additional parameters such as speed, acceleration and deceleration are calculated independently by the
controller. Furthermore, a multi-counter (CEU5) displays the current table position.
www.smc.de
Fans And Modular Drives
Customizable mix of components. Advances in electronics have led to significant improvements in
diagnosis and methods of treatment, but even the best electronics need fans to dissipate heat and actuators to carry out commands. Drive and fan specialist ebm-papst has developed a wide range of fans,
motors, gearboxes and accessory components. Since such equipment also has to be operated worldwide
with different supply voltages, the fans include a wide-range voltage input. They have also been designed
for minimum operating noise at maximum capacity. With their electronic commutation and external rotor
motor design, they ensure top efficiency while permitting adaptation of the air flow to match the application. This increases operating time
significantly, especially in mobile
devices. The modular design of the
components favours customized
assembly. This holistic approach
includes not only motors, sensors,
gearboxes and brakes but also the
controller and, where required, the
complete assembly of all mechanical components. Market-oriented
service, provided by experts, fullfils
the sector’s wide range of requirements. All units, whether drives or
fans, are subjected to a comprehensive final inspection by the manufacturer. In accordance with the
company’s GreenTech philosophy, they are produced with as little energy and material as possible and are
of course soldered without lead. In operation, the drives’ high efficiency is complemented by their low
energy consumption and thrifty use of resources.
www.ebmpapst.com
19
You need to design
a reliable product or
3D-MID solution.
Our Board-to-Board and Board-to-FPC
connector portfolio supports you with
◗ Compact size
◗ Wide product range
◗ High contact reliability
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MID solutions based on MIPTEC obtains
benefits like
◗ Miniaturization
◗ Expands design freedom
◗ Feature advancement
◗ Improve cost efficient
For more information, please go to
www.panasonic-electric-works.com/connectors
Panasonic Electric Works
Europe AG
Tel.: +49 (0) 8024 648-0 • Fax: -111
[email protected]
www.panasonic-electric-works.com
Medical Devices Draw-wire Sensors
Medical X-ray device users rely on high-precision sensor technology in order to operate these devices. In particular, digital X-ray
technology will not work without sensor-optimized controls.
Position Measurement
in X-Ray Devices
D
urability, reliability, compactness and high accuracy at
an affordable price are the basic requirements of measuring systems in medical technology. Draw-wire sensors in particular meet these requirements to a very high degree. X-ray machines have to provide high quality images in
different positions. In the past, an X-ray cassette with film had
to be manually aligned with the X-ray tubes. However, today
this process is performed digitally and fully automatically.
Modern X-ray equipment uses an imaging unit that digitalizes
the recordings directly. This saves time and development
costs. In order to produce high-resolution recordings for digital
equipment, the imaging unit must be exactly aligned with the
X-ray tubes. To ensure maximum flexibility, the imaging unit,
the X-ray tubes, the patient positioning table and the wall stand
can be moved on several axes. This means that patients can be
X-rayed whilst lying down, sitting or standing. Roesys uses
draw-wire sensors from the WPS-MK series to position these
mechanical components. The synchronization controller in the X-ray Digital tape
unit (Figure 1) uses the displacement measures
data acquired by the draw-wire sensors to move the imaging unit and the X-ray tubes in parallel to
each other. This parallel running ensures optimum focussing
of the X-ray tubes for the imaging unit. A total of five sensors
are located at the X-ray tube pillar, patient table and the wall
stand (Figure 2 and Figure 3).
1 The digital X-ray
All figures: Micro-Epsilon Messtechnik GmbH & Co. KG
system from Roesys
enables a wide variety
of positions. Precise
alignment of X-ray
tubes and imaging unit
is essential
Contact
MICRO-EPSILON MESSTECHNIK
GmbH & Co. KG
D-94496 Ortenburg
Phone +49 (0)8542 1680
Fax +49 (0)8542 168-90
www.micro-epsilon.de
20
2 A draw-wire sensor measures the height of the X-ray tube along
the pillar and a second sensor measures the height of the imaging
unit along the wall stand
Due to ease of installation, the sensors can be used separately
from any drives in existing systems. It is critical that optimum
focussing of the X-ray image is achieved using intelligent software and precise displacement measurement of the draw-wire
sensors. This results in reduced radiation exposure for the patient and perfect images for more extensive diagnoses.
Ultimately, these sensors work like a tape measure, although
one in which the displacement or distance information cannot
be read with the naked eye, but is output as an electrical signal.
Therefore, apart from the housing, the essential elements of a
draw-wire sensor include the spring, drum, measuring wire
and a protractor as a sensing element. The measuring wire is
attached to the component being measured and wound or unwound through the movement of the drum. This process converts the linear motion into a rotational movement, which is
then measured by the angle sensor. If the measuring distance
is reduced, the measuring wire is automatically rolled back
onto the drum. The necessary force is provided by a pre-tensioned spring. The cable tension is so great that even when the
unit is installed horizontally, wire sag is minimal and the measurement result is unaffected.
In principle, all commercially available and suitably sized angle
sensors can be used as sensor elements. This provides a large
variety of different output signals. From analogue signals (e.g.
potentiometric, 4 to 20 mA, 0 to 10 V) to incremental signals
(such as TTL) and fieldbuses (CANOpen, Profibus, etc.), almost
all popular interfaces can be used.
Draw-wire sensors for medical applications typically use multifilament spiral wire or hybrid potentiometers. These provide
the performance required for many applications at an affordable price. The difference between the two types is in their service life. While draw-wire sensors with wire potentiometers are
limited to approx. 200,000 cycles, hybrid potentiometers can
achieve up to one million cycles.
3 Another draw-wire sensor detects the vertical table position. A
great benefit is the compact design of the sensor
When higher demands are placed on service life and/or accuracy, for example, in CT tables, encoder-based sensor elements
can be relied upon. Here, a linearity of up to +/- 0.01per cent of
the measuring range and a considerably longer service life can
be achieved. In addition, the displacement sensors can be controlled via digital interfaces, which are increasingly finding their
way into medical technology.
In the development of draw-wire sensors for medical technology, Micro-Epsilon has been using injection-moulded plastic
enclosures for many years – in contrast to metal housings that are stan- Compact
dard in industrial applications. This measurement
guarantees not only the smallest pos- technology
sible size but also low costs with high
volumes. This means that full use can be made of the inherent
economies of scale that these sensors already offer. As large as
a CT scanner, X-ray machine or surgical table may seem at first
glance, there is rarely sufficient space for measuring technol
ogy. By combining different sensor elements and measuring
ranges with the available enclosure options, an optimum suitable draw-wire sensor can be provided for virtually any OEM
application. Draw-wire sensors are therefore used in series in a
variety of different applications.
Dipl.-Phys. Johann Salzberger
Dietrich Affeld
Managing Director Sales and Marketing at
Micro-Epsilon Messtechnik.
[email protected]
Mechanical Design at Roesys
Medizintechnik.
[email protected]
21
Customized drives bring two objectives of a laparoscope into position in order to get 3D images. These images make the minimal invasive intervention more precise and result in minimal traumata.
Driving Force of
3D-Visualization
P
atient-friendly minimally invasive interventions, for example in laparoscopies, are not conceivable without
high-resolution imaging systems. Two-dimensional, i.e.,
area-based, insights into the body have been an established
practice in endoscopy for many years. Three-dimensional images, such as the ones known from the movies, had not been
possible for the surgeon for a long time. For some years, a clear
change has been observed in this field; 3D technology has
found its way into endoscopy, helping optimize laparoscopic
interventions. Live images true to detail, corresponding to natural three-dimensional viewing, enable better hand/eye coordination, prevent signs of tiring in the surgeon and facilitate
tissue preparation inside the body. This has allowed modern,
high-resolution 3D laparoscopy to make the operating sequence and the subsequent healing process much less stressful for the patient and as free of complications as possible. This
innovative step into a less traumatic operating world has been
possible thanks to the interplay of high-brilliance optics, fullHD camera and drive technologies integrated into the manual
interventions.
Schölly Fiberoptic has placed one focus of its development
work over the last few years on the field of 3D technology and
achieved impressive results. The new laparoscopy system Einstein Vision (Figure 1), which has already proven itself in practical use, offers full-HD quality in 3D, providing an image true to
reality of extremely fine structures inside the body (Figure 2).
This allows precise separation of tissues and exact positioning
of surgical needles. The principle of the new system is based
on the proven laparoscopy technology. In contrast to conventional solutions, however, this laparoscope is equipped with a
3D camera head (Figure 3) and a robot arm that stabilizes the
camera motion.
1 The 3D laparoscopy system Einstein Vision
offers spatial vision in full-HD standard
22
2 Extremely fine
Figures 1+3; Schölly Fiberoptic GmbH, Figure 2: University of Tübingen, Germany
anatomic tissue
structures can be
clearly seen; they
can be treated
more carefully and
separated more
precisely; surgical
instruments can be
exactly positioned
The basic functioning of three-dimensional photography can be readily explained using an analogy from nature: In humans and in many animals, the eyes are arranged
such that they are able to see their surroundings simultaneNature as an ously from two viewing angles. The eyes thus provide two
example images differing from one another. The brain combines
them to a single image and calculates the spatial visual impression on the basis of the deviations. If a human being had
only one eye, he/she could estimate distances and spacings only very poorly and
would perceive his/her surroundings like in a plane.
To create spatial images, 3D cameras basically use the same procedure: Two pictures
are taken simultaneously from two different viewing angles. In doing so, the objectives must have a defined distance from one another, the so-called stereo base. In the
human eye, for example, the distance is approx. 6.5 cm. The “double image” of the
camera is combined to a three-dimensional picture as soon as the surgeon – similarly
to what happens in the movies or on television – wears adequate glasses. The result
of this procedure is a razor-sharp spatial image of the body interior, which allows the
surgeon to operate with greater safety and less stress on the tissue, for example
when removing tumors or lymph nods, or reconstructing the pelvic floor.
»
Innovative solutions
for medical devices
from concept to series
production
> Medical microelectronics
(design service, substrate
manufacturing, semiconductor
packaging, board assembly,
test services)
> Batteries and battery packs
for active implants
> Hermetic feedthroughs
for medtech implants
Contact
Micro Systems Technologies
Neuhofstrasse 4, CH-6341 Baar, Switzerland
Phone +41 (43) 266 11 28
Fax +41 (43) 266 11 11
info @mst.com
Physik Instrumente
GmbH & Co. KG
D-76228 Karlsruhe
Phone +49 (0)721 48460
Fax +49 (0)721 4846-1019
www.pi.ws
MST Group. Active around the globe, the
Micro Systems Technologies (MST) Group
consists of four technology companies
with more than 1000 employees in three
countries:
> DYCONEX AG (CH)
> LITRONIK Batterietechnologie GmbH (DE)
> Micro Systems Engineering GmbH (DE)
> Micro Systems Engineering, Inc. (USA)
3 The principle of the new system is based on the proven laparoscopy technology, but, in
contrast to conventional solutions, the laparoscope is equipped with a 3D camera head
23
www.mst.com
MST_Ins_MED-engineering-international_55x250_E.indd11.11.13
1
10:45
Figure 4: PI miCos
4 The driving force for the simultaneous displacement of the two objectives required for creating the
3D image is a direct current drive. The objective holders, firmly coupled with the drive, guarantee synchronous picture-taking at different distances
»
The distance of the objects to be photographed from the
objectives is variable. To nevertheless guarantee a clear image,
the camera has been equipped with a zoom function. To this
end, the two objectives are displaced synchronously in linear
direction. The driving force for the simultaneous displacement
of the two objectives required for creDC drive ating the 3D image is a direct current
moves the drive installed in the camera head of
objectives the new laparoscope. The objective
holders, firmly coupled with the drive,
guarantee synchronous picture-taking
at different distances. All the surgeon has to do is to actuate a
switch on the camera head (Figure 3).
Finding a suitable drive was by no means a trivial endeavor. A
series of application-specific requirements had to be fulfilled,
such as the constricted installation space available in the camera head and the required low starting voltage of less than 1 V.
Despite this low voltage, the comparably heavy objectives
must be displaced precisely and over a relatively long travel
range of 12.7 mm in any position. In addition to that, the high
reliability and lifetime requirements of medical devices had to
be fulfilled as well.
These application-specific requirements could be readily fulfilled thanks to a drive solution designed by PI miCos for this
application. This company, a subsidiary of PI (Physik Instrumente) from Karlsruhe, Germany, is specialized in flexible positioning systems for a wide range of applications and has also
been able to achieve a “tailored” solution for the displacement
of both objectives in the 3D laparoscope (Figure 4).
able to do this, the drive is arranged linearly, relative to the direction of motion. The rotary motion is effected by means of a
high-precision toothed gear and transmitted to the fine-thread
spindle, which then moves the slide containing the holder for
the two objectives. The sliding bearing between slide and
guide is low in friction and backlash due to a special coating.
The coating and the high-torque start of the direct current motor contribute to the high-speed and high-precision displacement of the objectives despite the low voltage. This ensures a
direct response to the control signals.
Moreover, the small motor with bell anchor, iron-free rotor coil
and noble-metal commutation impresses with its low rotor
moment of inertia and can be easily controlled thanks to its linear characteristic. This function is performed by the motion
controller integrated into the control of the laparoscope. To
limit the travel range, a small limit-switch board has been integrated into the drive system. Despite the constricted installation space, it has thus been possible to install a customized and
reliable drive solution for the objectives in the camera head of
the laparoscope. In the future, physicians and patients will
benefit more and more often from the razor-sharp three-
dimensional pictures from the body interior thus achieved. Birgit Bauer
is Business Development Manager Health Care
at PI (Physik Instrumente).
[email protected]
The driving force is a small direct current motor. The compact
miniature drive of only 10 mm in diameter and, including the
gearhead, 42 mm in length impresses with its high power density. Its low current consumption and low starting voltage of
less than 1 V are further properties that seem to make it the
ideal choice for this application. Thus, this powerful minidrive
supplies 0.1 W, which allows to displace heavy objects of almost 100 g in weight bidirectionally without problems. To be
Ellen-Christine Reiff
is employee at the editorial office Stutensee.
[email protected]
24
Primary Batteries
For active implants. Litronik Batterietechnologie
is a supplier of primary batteries for active
medical implants such as pacemakers and
implantable defibrillators. The company is
part of the MST Group
and supplies sophisticated, customized
solutions as well as
off-the-shelf products
at the highest levels of
quality under dry room
conditions. Small form
factors, long service life
and outstanding reliability are just some of
today’s demands. The
electrochemical systems used within the
primary batteries are
based on lithium-iodine
and lithium-manganese dioxide, and cover
three performance ranges: High energy
batteries with lithium-iodine technology for
implantable pulse generators, for example
pacemakers. They provide current in the µA
range at approximately 2.8 V at the start of
their service life. Medium range batteries with
PowerSolutions
lithium-manganese dioxide technology for
implants that require mid-range pulse power,
for example pacemakers with telemetry functions. They provide
current in the mA
range at approximately
3.0 V at the start of
their service life. High
power batteries with
lithium-manganese
dioxide technology for
implants that require
the highest pulse power, for example defi
brillators. They provide
current in the ampere
range, likewise at
approximately 3.0 V, at
the start of their service life. All batteries
undergo an X-ray ana
lysis and electrical tests. A strict quality management system and 100 percent traceability
on processes and materials assure the high
quality level required for medical applications.
The manufacturer is certified according to DIN
EN ISO 9001.
www.mst.com/litronik
for industrial and medical systems
r
+ Medical Powe
●
ty
+ 3-Years-Warran
●
able
+ Long-Term Avail
●
mNSP3-450P-USB
ATX Nonstop Power
Integrated UPS function
Various battery packs
With USB interface
BEO-Series
Fanless 40–500 W
High Voltage Power Supply
For mass spectrometry applications. HiTek Power, a manufacturer of standard and custom-designed high voltage
power supplies, has added a seventh series to its range of power supply modules designed specifically for the mass
spectrometry market, the Series MSRD. The Series MSRD is
a range of high stability, reversible source power supply
modules with a floating +3 kV 400 µA detector output.
These modules offer 1.8 W output power at voltages
between ±5 and ±12 kV depending on the model, low
ripple and provide reliable operation even in short circuits
or arc conditions. The design of the floating detector has
been implemented to ensure minimal additional common
mode ripple on the source and very small levels of crosstalk, this attention to detail ensures high levels of final
system performance. The modular design approach means
the company can offer an extensive range of performance
combinations to suit different requirements. Simple
changes can be made to any mass spectrometry module if
required, such as changing cable lengths and connectors
or, if preferred, the manufacturer can offer a completely
new custom solution using its proven power conversation
topologies, control methods and mechanical knowledge.
www.hitekpower.com
25
Powerful and very compact
High efficiency up to 94 %
Extended temperature range
BET-Series
ECO-Friendly Design
ErP and CEC level V compliant
Powerful desktop adapters
Secure, robust and reliable
Let's meet in Hall 2.139
Bicker Elektronik GmbH
Phone: +49-906-70595-0
www.bicker.de
Medical Devices Carrier Systems
Carrier systems for medical technology are part and parcel of
everyday life in hospitals. They are supposed to optimize processes in hospitals by sophisticated ergonomical solutions.
Facilitating Daily Work
at the Hospital
ment project, the work stations of over fifty doctors and nurses
and professional caregivers were revamped. Priority was given
to clean and modern processes.
»The objective was to make work with the necessary medical
technology as simple and easy as possible for the user,« says
Josef Seitlinger, who was the CIM med employee in charge of
project planning for the medical work stations at the clinic. Today, Seitlinger is business manager at medAS. The company
furnishes medical work stations and has always been using carrier arms made by CIM med. From conception to implementation, passing by project planning, the manufacturer of carrier
1 Ursula Thurner, head of anaesthesiology at the Klinikum rechts der Isar, highly estimates the flexibility of the anaesthesia workstation
26
Figure 1: Michael Stobrawe, Figure 2: CIM med GmbH
E
fficient and hygienic processes are essential for clinical
institutions like the Klinikum rechts der Isar in Munich.
This clinic, which is run by Munich’s Technical University,
is considered one of Germany’s finest hospitals. Founded back
in 1834, it has always been one of the most modern in the
country. Today, it boasts over thirty clinics and departments,
and over 1,100 beds. Each year, about 300,000 people are
treated here on an in-patient and out-patient basis. The Klinikum rechts der Isar has special know-how in anaesthetics and
pain treatment. The anaesthesiology department is one of the
leading ones in its field. It is involved in over 45,000 anaesthetic operations each year. As part of a renovation and refurbish-
2 The triple-jointed arm integrates all cables. As a result the risk
of infections is reduced significantly
systems was responsible for the clinical work stations. »Ergonomic solutions were needed for the stationary and mobile
work stations, in order to ensure that care focus was always on
the patient.« As a trained anaesthetic and ICU specialist,
Seitlinger knows what’s important. »Monitors must always be
at eye-level with the users and any keyboards and supports
must be easily accessible. It has to be taken into account that
operations can last several hours. You need good posture to
concentrate fully on the patient for that length of time,« says
Seitlinger, recalling his own professional experience.
In addition to being installed as stationary solutions for recovery rooms, the systems are used in mobile anaesthetic units at
the Klinikum rechts der Isar. »We developed a new solution for
these together with the staff at the clinic,« says Josef Seitlinger.
Merging infusion technology, the patient data management
system (PDMS) and the anaesthetic devices into a single care
unit was one of the requirements of the users. »We worked out
an individual solution together with the manufacturer,« says
Seitlinger. A fundamental aspect is the component grounding
solution offered by these systems. This allows other electronic
devices to be connected directly
Besides the medical devices themselves, the system mounts
to the anaesthetic unit. As a rule,
naturally played a major role in designing the work stations at
Connecting
most of these units feature intethe Klinikum rechts der Isar. »The needs of the users were crufurther devices
grated monitors to show vital
cial when conceiving the stations,« says Helmut Oschwald,
safely and easily
signs and levels of anaesthetic.
General Manager Engineering and Construction. »Will they be
But doctors and caregivers often
standing the whole time? Are they sitting down or switching
need other data that have to be shown on a separate screen,
between standing and sitting?« The different areas of applicawhich is usually larger, as well as on a PDMS. Height-adjustable
tion mean that the mounting solutions had to feature adjustand laterally movable carrier arms with component grounding
able heights and be extremely flexible. In order to clarify these
were used to connect these systems to the aesthetic unit. The
criteria, Josef Seitlinger conducted numerous interviews with
unit was also subjected to a tipping test,
the later users. They were able to try out
that proved that it would not fall over even
the systems hands-on with test installaContact
when leaning at a 10-degree angle.
tions. »The Klinikum rechts der Isar ultiCIM
med
GmbH
mately found the suitable carrier soluD-80939 München
»The flexibility offered by this solution was
tions for its personnel in our systems,«
Phone +49 (0)89 978940800
a key criterion governing our choice,« exsays Seitlinger.
Fax +49 (0)89 9789408-29
plained Ursula Thurner, head of anaesthesiwww.cim-med.de
ology at the Klinikum rechts der Isar. »They
One of the salient aspects of these sysleave a lot more space for the actual work.«
tems is that all the cabling for the moniMs. Thurner (Figure 1) also rated the ergonomic adjustment
tors and devices is placed inside the carrier arm (Figure 2). This
range of the mounting solutions highly. »Our staff members
promises a high level of hygiene, flexibility and work safety.
are very happy with the mounts,« she says. Ursula Thurner
Enclosing the cables for the monitors and patient data manpraised the systems from the standpoint of hygiene as well. At
agement systems (PDMS) inside the carrier arms avoids creatthe Klinikum, the modern carrier solutions for clinical technoling a fertile ground for germs by having tangled cables lying
ogy contribute to healthy and safe working conditions. For the
around that are difficult to clean. »Open cables collect dust easMunich hospital, this means continuing a tradition that began
ily and can be contaminated by infusions during emergency
at its founding over 160 years ago: medical care at the highest
situations,« says Seitlinger, who knows about daily work in hosand most modern level.
pitals. »These areas are often difficult to clean or to disinfect.«
Integrated cable management lowers the risk of infections for
patients from these germ sources. The materials used to build
the systems are made to help with hygiene. They are of anodized and anti-microbial powder-coated aluminium, which is
very resistant to clinical disinfectants. Thanks to integrated
Manuela Loibl
cable management, the systems can also be adjusted quickly
General Manager Marketing & Sales at CIM med in Munich, Germany.
to handle emergencies.
[email protected]
27
Medical Devices Product Development
The approval process for medical devices often appears to be
an obstacle to developing innovative products. But there is another way – an experience report.
Successful With
Outsourcing Partners
I
t is a long way from an idea to a finished product, and many
issues need to be considered as regards medical technology. For example, technical documentation is required for
products in all risk categories (I, IIa, IIb and III). The European
Association for Medical Devices of Notified Bodies has summarized the minimum requirements in the Technical Documentation (NB-MED/ 2.5.1/Rec.5 rev.4):
++ Product description (variants, application, accessories etc.)
++ Product specification (norms/specifications, construction
and production diagrams, data sheets, manufacturing
specifications, quality assurance measures, designations,
instructions for use etc.)
++ Product verification (calculations, simulation results, test
results, risk management etc.)
++ Product validation (manufacturing process, packaging, application process, software etc.)
This documentation effort is a daunting prospect for many developers. It is true that at first glance, it would be easier to deal
with the technical tasks only, instead of producing documentation. On closer examination, however, it soon becomes apparent that the regulations also have advantages. There is hardly a
programmer who has not regretted that his source code was
not properly commented while it was written.
All figures: TQ-Group
1 Neurostimulator therapy is intended to
restore a patient’s mobility after a stroke,
for example
28
2 Neurostimulator
mentastim has been
developed for two
different user groups
The development of the neurostimulator ›mentastim‹
( Figure 1) shows that the path to successful auditing of a medical device can take a different course. TQ-Systems has developed this therapy device, by means of which nerves and muscles are stimulated electrically, from scratch. The device
(Figure 2) enables movement sequences to be relearned or
learned again after diseases of the central nervous system, a
stroke, for example. After being instructed on the use of the
device by a doctor or therapist, the patient can use it independently around the home. ›mentastim‹ functions according to
the principle of EMG-triggered electrostimulation. In this, an
increase in the muscle potential through purely mental movement suggestion is measured in the form of the so-called EMG
value. If this value reaches a defined threshold, the device triggers an electrical stimulation. The brain receives positive feedback of successful activation as a result of this stimulation.
This therapy is based on the scientific knowledge that, after
damage to brain areas, the central nervous system stores the
lost movement patterns in other, undamaged areas, and can
therefore learn these again. This effect, which is known as neuroplasticity, is measurably strengthened by EMG-triggered electro
stimulation.
One of the greatest challenges today is to bring increasingly
complex products on the market within ever shorter periods of
time. What is decisive here is making it clear up front as to who
contributes to the project, what this contribution is, when it is
made, and how it is included into the overall project. Different
process models have established themselves as tools for answering these key questions. The palette ranges from classic
phase-oriented models such as the waterfall, V, spiral or stagegate model right up to agile models such as Adaptive Software
Development (ASD) or scrum. Every model has its own view of
the development process, with corresponding advantages and
disadvantages. To find the most suitable model for a project, one needs to
know the models. Disabuse yourself
immediately of the notion that there
is a single model that will proceed
from the start to the finish for completing a project successfully! Instead,
consider in which phase you need
which processes. Combine models or
parts of models, define iteration loops
and use these to create your own personal process model. This should
then be understood, accepted and
also lived by all project participants.
Individual
process model
A review process was performed at the
end of each phase of the development
of the neurostimulator. In addition,
gates were defined (Figure 3) at which
a go/no-go decision could be taken. In
the case of a no-go for the next phase,
a decision for an iteration loop could
be taken (spiral model), or the entire
project could be cancelled. What initially appears to be drastic could be
sensible, because if it is deter-
»
Contact
TQ-Group
D-82229 Seefeld/Gut Delling
Phone +49 (0)8153 9308-475
Fax +49 (0)8153 9308-7475
www.tq-group.com
29
Medical Devices Product Development
waterfall model
stage gate
model
spiral model
V-model
3 An individual model was
derived from the combination of four process models. This model was used to
successfully develop the
neurostimulator
stop
stop
stop
stop
adjusted procedure model
»
mined at a gate that continuing with the project is uneconomical a great deal of time and money could be saved.
The early project phase cannot be evaluated highly enough.
The cornerstone of the project is laid here. All errors that are
committed at the beginning must be corrected at a later stage
at a high cost in terms of time and money. Consequently, the
first document to be created according to the regulatory specifications – the specification sheet with the intended purpose of
the medical device – is decisive for the success of the project.
In respect of DIN EN 62366 (Application of Usability Engineering to Medical Devices) as well, it is worthwhile completing
pending tasks in an orderly manner. Ultimately, a product
should be developed for a specific application, and be used by
one (or more) user group(s) in an extremely specific field. The
more precisely the following questions can be answered, the
better the product will later be accepted by the customer.
++
++
++
++
++
Will the product meet its purpose?
Can product ideas and features be developed?
Can decisions be taken in the development process?
Can risks be identified and avoided?
Can the product be verified and validated?
Numerous sampling techniques are available for processing
product requirements. Examples of these are expert interviews, individual or group interviews, questionnaire techniques or on-site observation. Where preceding models or initial functional prototypes exist, these should be used for the
requirements analysis. This could occur within the scope of a
comparison or benchmarks, usability tests or focus groups, for
example. Regardless of the technique selected, the information generated must be evaluated and weighted. However, it is
precisely in the area of interview techniques that experience is
required to establish the core of the problem issue. Interviewees often tend to consider possible solutions without being
aware of the problem issue. A good example of this is a quote
from Henry Ford. He is reputed to have said once: »If I had
asked people what they wanted, they would have said faster
horses.«
The neurostimulator is a home-care product, and the main
user is consequently the patient. He/she obtains the device
from a doctor or therapist on prescription. In addition, the doctor or Where is this
therapist should be able to adjust journey headed?
the device for the individual patient,
and requires the option to be able to
save therapy protocols to check the success of the therapy and
the settings. As a result, the device must meet the demands of
two user groups with differing levels of education, prior knowledge and capabilities – the clinic and the therapist on the one
hand, and the patient in a domestic environment on the other.
Based on the different requirements, different user profiles
have been implemented.
There are additional stakeholders, besides the patients. Co-inhabitants or family members also come into contact with
home-care devices. Another example is where nursing staff
prepare or clean the device. Here, it is useful to work through
different scenarios with regard to usability and risk minimization, and to incorporate experiences gained into the development process at an early stage. If the device is later to be added
to the product catalog of the statutory health insurance company, the corresponding requirements and prospects of success should be ascertained. Don’t forget the stakeholders in
your own organization. Depending on the service provision
model, the service division could have certain demands in
terms of maintainability or remote diagnosis. If the device is to
be introduced into the market in different countries in the long
term, it is worth seeking out requirements from Sales and Marketing.
30
The notified bodies are particularly important stakeholders, as
they need to be exposed to the product intensively and need
to check all documents for absolute accuracy. The auditing department often induces a kind of testing anxiety in developers
and those responsible for the project. This results in a mindset
of creating the development documents “for the notified body” and not
All stakeholders for the sole purpose of documenting
considered? the development process. At the end
of the project, the final approval of
the medical device then hangs over
the team like the sword of Damocles.
It is better to see the notified body as a development partner.
The example of the neurostimulator shows that it can be
worthwhile to communicate in good time and openly. In this
way, agreement was reached as to a type of cumulative certification. First, a functional prototype was tested and accepted
on the basis of fundamental electrical safety. Then, environmental tests (EMV, temperature range, first software components) were performed. The third test comprised the final acceptance of the device, including all mechanical components.
The advantages of this procedure are:
++ Critical documents such as risk evaluation, application of
relevant norms etc. are checked and confirmed in an early
phase
++ Deviations are detected early and can be remedied before
the next check within the scope of the normal development process
++ Slim quality control loop
++ Unpleasant surprises during the final audit are avoided
The notified bodies have viewed this somewhat uncommon
procedure extremely positively. The testers can focus on the
relevant areas, and can more easily plan the test into their busy
schedules. In short, it is worthwhile to identify the stakeholders and to communicate with them.
As an experienced, certified manufacturer of medical devices,
the TQ-Group offers E2MS services during the development
and approval of medical devices, and assists in removing obstacles and in bringing the product to the market quicker. The
TQ-Group is at your service during the entire product lifecycle
– from the product idea and determination of requirements, to
planning and development right up to production, maintenance and support for the medical device. This means the
medical device manufacturer is free to concentrate on the clinical or medical applications.
Therese Stary (Industrial Engineer)
works in product management at TQ-Systems in Seefeld, Germany.
New Products Fluid-Isolation Valve
Miniature valve for higher pressure ratings. The demand in analytical and
medical technology for compact fluid-isolation valves with high pressure
ratings and good vacuum properties has prompted ASCO Numatics to develop the new series 068 valves. Distinctive features of the innovative flapper
mechanism are the low number of moving parts and the
corrosion-resistant fluid isolation from the solenoid
operator. This design provides for a high level
of operational and process safety. The
solenoid valves are available in 2/2 NC, 2/2
NO and 3/2 universal function in orifice
sizes from 0.8 to 1.6 mm and can be used
for vacuum applications and pressure
ranges of up to 8 bar. High-quality materials
such as PEEK, FFPM, FPM and EPDM allow the
valve to be optimally adapted to different
application needs. In comparison to valves
with similar characteristics, it was possible to
further improve their self-draining and
flushing capability. Due to the valves’ low
power consumption of 4 W (only 1.5 W with
optional battery operation) the temperature
rise of the fluid is further reduced.
www.asconumatics.eu
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TVIWWYVIWFYXEPWS©
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MRRSZEXMZI¾S[GLERRIP
MRXIKVEXIH[MXLMRXLIWIRWSV
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'137WMKREPGSRHMXMSRMRK
WTEGIWEZMRKQMRMEXYVI
4'&QSYRXEFPILSYWMRKW
[[[WIRWSVXIGLRMGWGSQ
Rocker Valve
Energy saving impulse version
Bürkert has introduced the first rocker valve as impulse version (bistable). The Type 6624 valve allows substantial energy
savings in a compact design in comparison with monostable
valves and also features very good flushability. According to
the manufacturer, there is no comparable product on the
market yet. The valve consumes no energy after the switching
process, which is explained by the valve’s functioning principle: a standard rocker valve has two seats, which are opened
and closed as a result of electric current. However, they return
to their original state as soon as the current is discontinued.
Not so with the pulse version: a current pulse is used only to
open a seat, for example – afterwards, it retains its position
without the supply of power. This is made possible by a permanent magnet that attracts the iron core of the rocker valve.
The valve can be returned to its original state by means of
another current pulse. The Type 6624 valve is therefore available in both a neutral and bistable version. Both versions are
based on the time-tested and reliable rocker principle and the
innovative TwinPower actuation concept
enables a drastic reduction of the size,
with no decrease in performance. The 10 mm wide
media-separated rocker
valve with a diameter of
1.2 mm and pressure
resistance of 2 bar therefore features similar
performance characteristics to a conventional
16 mm valve. In the
standard version the
integrated power reduction reduces the power
consumption by 75 percent and the pulse version generally needs even
less power. The use
of high-quality
materials makes
the valves suitable
also for use with
aggressive media. It is
available in a 2/2-way and
a 3/2-way version. Piloting of the impulse version is achieved
via three strands, which eliminates the need for pole reversal.
Nevertheless, correct polarity is important to ensure proper
functioning of the valve.
www.buerkert.de
32
Gas Diaphragm Pump
Small, reliable and energy-saving
Gardner Denver Thomas has once more expanded its range of
gas diaphragm pumps. The series 1010 is the smallest miniature diaphragm pump ever developed by the Thomas Division. The smallest product in the range of motor diaphragm
pumps only weighs about 15 grams. Even more impressive is
the 1010’s overall performance. Reliability, extremely low
power consumption and high power density in combination
with miniaturized dimensions were the main focus of this
development. All these properties have been confirmed by
comprehensive tests and 4000 hours of non-stop operation.
The newly developed valve unit guarantees optimum delivery,
also of wet gases, and enables good controllability for volume
flow rates ranging from 100 to 800 ml/min. Hence, the majority of applications in the field of gas analysis are covered.
Different diaphragm versions, optimized for vacuum duty
only as well as combined pressure and vacuum use, are available. At present, durable bell-type armature motors are used
to drive the pump. These are particularly efficient and easy to
control thanks to their ironless winding. They even fulfill ope
rational requirements for Ex-certified devices. A drive for less
rigid requirements is currently in preparation. The pump head
can be rotated by 180°, which facilitates flexibility when inte-
grating the pump. Assembly of the pump head, chamber and
console is realized with two brackets. These brackets create a
uniform pre-load resulting in a reproducible and consistent
pneumatic performance for the pump’s entire life span. Target applications for the 1010 series are primarily portable gas
detection and warning devices next to medical engineering
and laboratory technology – but in particular for devices with
limited mounting space.
www.gd-thomas.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.
challenge 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
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.
33
MED Electronics Embedded Systems
Manufacturers of medical technology need to keep pace with the
speed of innovation in computer technology. ODM services can
be helpful here and accelerate the way to individual products.
Customized
Medical Computers
P
resently, demands on medical devices and medical IT are
rising rapidly, including requirements such as new concepts with multi-touch control for more convenient operation, data security of networked solutions – for patients‘
data on demand at any time from any location, real-time
remote monitoring of vital patient data for optimizing intensive care, more precise graphics for minimal-invasive surgery
and diagnostic findings and software based on Open Source for
increasing the long-term availability and security. The goal is to
improve computer technology used in the medical environment and, aligned with this, to constantly improve overall
medical-technical equipment and solutions. Until now, we all
believed the next solution optimization should be an improved
generation of processors with x86 architecture. Currently,
however, even in the area of medical technology, the question
has arisen as to whether, at least in part, developments in consumer electronics should be taken on board, breaking away
from familiar high-performance desktop or notebook systems
34
All figures: Kontron AG
1 Original Design & Manufacturing (ODM) services make medical computing platforms designed and manufactured from one single
source available to manufacturers of medical equipment
2 In this EN 60601-compliant systems, the CPU boards are
also developed in-house
and moving towards flexible, small mobile systems i.e. tablet
PCs. For this type of mobile system simpler processor concepts are required than those in the classic world of computers
(i.e., SoCs based on ARM, MIPS, PowerPC or x86 architectures).
Such a change in the market for embedded and medical computer technology also affects the required operating systems
and their demands on hardware resources and the way in
which application programs (apps) are used. What’s more,
ARM processors have, for example, already been tried and tested in other markets and proven their long-term availability. So
does this all mean that sooner or later a transformation of
medical computer technology to such mobile low-power platforms will become necessary? This is a legitimate question
which medical device manufacturers should ask themselves
before defining new generations of devices.
Regardless of whether manufacturers prefer to implement
ARM or the new Intel Atom processors of the 22 nm SoC series,
one thing is for sure: these technology platforms have to be
available long-term (sometimes well over a decade) and span
several generations of a technology platform. This is because
they not only have long development and certification cycles
until final approval has been obtained and market launch has
taken place, but also because long operating lifecycles are required. For this reason, many medical device manufacturers prefer using standardized embedded
form factors for electronics such as COM Express modules. On one hand, COM Express mod-
ules simplify the electrical design, helping to speed up system
designs in general. On the other hand, they ensure that for the
complete solution functionally identical building blocks are available even Overcoming
after several years, if, contrary to ex- technology
pectations, a specific component is
barriers
discontinued prematurely. This makes
OEMs more independent of processor
or component suppliers. It is particularly important, as service
lives in medical technology and subsequently the lifecycle of a
medical device often goes beyond the lifecycle of embedded
computer technology.
If medical OEMs can use standard embedded form factors, it
enables smooth migration which, in turn, helps to overcome
technological barriers. Motherboards in the Pico-ITX or Mini-ITX
format or SMARC standard modules are, for example, already
available with x86 as well as ARM processors and can thus be
implemented into either established or new solutions. Solutions with new processor architectures can be implemented
into existing system designs relatively easily. On the soft-
»
Contact
Kontron AG
D-85386 Eching
Phone +49 (0)8165 77-777
Fax +49 (0)8165 77-279
www.kontron.com
3 The Motherboard KTQ67/FLEX-MED with its two EN60601-1-compliant, galvanically isolated Ethernet interfaces is used, for example, in diagnostic systems
35
MED Electronics Embedded Systems
4 This IEC606011-compliant Gigabit
Ethernet card makes comparably
expensive medical LAN insulators
superfluous
»
ware side, uniform programming interfaces, such as KEAPI,
help to make migrations easier. Additionally, Kontron is an embedded manufacturer and provides extensive migration services. But above all, it is important that this range of services is
provided by a single source in order to benefit from valuable
synergies.
For many medical device manufacturers, purchasing standard
groups of components plus integration off-the-shelf does not
suffice. They would rather receive complete systems which
they can deploy in their equipment as ready-made components. System responsibility for these ready-made components should be single sourced if possible. In order to provide
this, a manufacturer of medical computers has to be able to
develop and produce complete customized systems. The
manufacturer therefore has to master the whole process from
the board development to the manufacturing of customized
medical computers and ideally offer a wide range of Original
Design & Manufacturing (ODM) services. This entails – In addition to the systems themselves and their assembly, the management of the entire supply chain, plus lifecycle management
must be involved. With this synergy the medical device manufacturer can fully concentrate on his actual core competences
and purchase the medical computer as a just-in-time, readymade component.
Kontron offers this range of ODM services and has, for many
years, carried these out as a reliable partner for leading global
medical device manufacturers. Its systems and components
for medical devices are designed to meet exact individual customer requirements. All products fulfill the customer’s need
for easy certifiability and long-term availability. Plus, they are
designed to meet specific environmental requirements so that
the solutions offer long-term stability and reliability. Add to
that the flexibility in manufacturing and engineering which
means that individual customer requirements can be met. Ensuring continuous delivery quality as well as identical configuration (right down to chip level), the use of optimized supply
chain and the EN60601-compliant development are part of the
service which have solidified the good reputation of the company in the market as a medical computer manufacturer with
more than 30 years of experience in the management of supply chains and installion and establishment of the corresponding processes and QM systems.
The interaction of design and manufacturing expertise makes
system responsibility almost free of interfaces. Original Design
& Manufacturing Services are therefore a guarantee for high
product and service quality. The logistics system, which has
been operating for years for manufacturing medical computers, ensures the company’s consistently high delivery reliabi
lity. And the delivery quality is excellent. Recently, the company once again received a Supplier Performance Award, which
distinguishes the company for its long-standing high product
and service quality as well as delivery performance. With a
result of 99.98 percent the delivery performance was rated exceptionally high.
Nevertheless, there will be no resting on these laurels. For this
reason, the Augsburg site will undergo expansion in the coming years and be developed into a high-tech center, where the
company’s innovation power will be concentrated. This will
further increase the attractiveness of this internationally recognized high-tech company. Medical OEMs will profit from
these investments and enjoy even closer and more sustainable
interaction between the two pillars of ODM (i. e., ’design‘ and
’manufacturing‘). Ultimately this will further increase the quality of medical computing solutions for OEMs and secure sustainability.
Jens Unrath
is Director Business Development Medical at Kontron.
36
Company Profile
Sphinx Tools Ltd.:
Your partner in medical technology
Sphinx Tools Ltd. sets standards for optimum quality and security. As a partner and OEM manufacturer of high-quality instruments in the field of medical technology, we have acquired an
extensive knowledge base. Our in-depth expertise is based on longstanding partnerships with
leading international medical technology companies.
Sphinx Tools Ltd.
Switzerland
Gewerbestrasse 1
CH-4552 Derendingen
Phone +41 32 671 21 00
Fax +41 32 671 2111
sphinx@ sphinx-tools.ch
www.sphinx-tools.ch
Corporate profile
More than 50 years of
experience in the field of
medical technology.
Specialisation in the
manufacturing of cutting
geometries such as drills,
milling cutters, taps, etc.
The cutting edge geometry technology from
Sphinx Tools Ltd. guarantees low torque and
thus a lower heat generation. The precisely
ground and burrless instruments are extremely durable even under the most challenging
conditions and can be sterilised over and over
again. Our development department is a
high-tech Iabaratory specialising in measurements to within a thousandth of a millimeter.
We ensure that our customers can use their
instruments with absolute precision and in
the best interests of patient health.
W
W
W
W
W
W
Thread cutters
Schanz screws
Wire drills
Steinmann pins
Dental drills
Screwdrivers
Expertise
W Long-term partner in the medical
technology sector as OEM manufacturer
W Support with the selection of materials and
construction
W More than 100 years of machining expertise
W Know-how in the processing of high-quality
Quality management system
in compliance with
materials
W DIN ISO 9001:2008
W DIN ISO 13485:2003
W FDA registration: 9614438
W High flexibility
W Complete supplier
W Optimal manufacturing solutions for small
and Iarge series production
Products
W Delivery times according to customer’s
W Surgical bone drills
W Cannulated instruments
request
37
MED Electronics Embedded Modules
Diagnostic systems with large high resolution displays are
more and more common today. State-of-the-art, high-end processor technologies are a prerequisit.
Controlling Large
Displays
1 Large screen full HD displays make diagnosis easier but require high computing and graphic power
38
Figure 1: EIZO Europe GmbH; Figure 2: Intel; Figure 3: MSC Technologies
L
or computer tomography (CT) images (Figure 1) positioned
side by side. The displays are installed well protected in highquality, hygienic housings and can be fully integrated in operating rooms. Furthermore, large screen monitors are used for
digital signage solutions in order to provide patients and visitors with relevant information about the hospital. The interactive digital multimedia display systems feature HD resolution
of 1080 pixels, 3D-graphics or high resolution videos. In order
to control these large screen displays and meet the demanding
High-end displays as diagnostic imaging systems and for comrequirements of image capture and image processing systems,
puter-assisted surgery in operating rooms can significantly imvery high processor and graphics perforprove the presentation of digital images.
mance is necessary. The recently introIn addition, the large monitors are an ideal
Contact
duced 4th Generation Intel Core procesreplacement for conventional light boxes
MSC Technologies
sors are ideally suited for this. As with the
used in all hospital treatment areas.
D-76297 Stutensee
predecessor 3rd Generation Intel Core
Thanks to their large format of up to 70
Phone +49 (0)7249 9100
pro
cessors, these new processors are
inches (180 cm), they are suited for lookFax +49 (0)7249 7993
www.mscembedded.com
manufactured on 22 nm process technoling at and discussing several X-ray and
ogy (Figure 2). However, the architecture
magnetic resonance tomography (MRT)
arge screen, full HD displays are increasingly often used in
clinical environments. They offer specialist medical personnel the possibility to display medical images in superior image quality and with the necessary color and grayscale.
For example, high quality images of parts of a patient’s body
being examined can be displayed in their original size or enlarged to show greater detail.
2 The 4th Generation
Intel Core processors
are manufactured on
22 nm Tri-Gate 3-D
transistors process
technology
** Cache für alle vier Cores und den Grafikprozessor
of the new devices was optimized. Among other things, improvements include new microcode and extended registers as
well as an expansion of the vector processing unit. The Intel
Advanced Vector Extensions 2 (Intel AVX2) uses 256 bit vectors
and powerful, even larger buffers. Thanks to an improvement
in the power management, as compared to the previous processor generation, the power consumption can be reduced by
a very efficient sleep mode. The Intel Advanced Encryption
Standard New Instructions (Intel AES-NI) enables high-performance data encryption without a heavy load on the CPU.
A high graphics performance of the processor is also important
for displays used in a clinical environment. The 4th Generation
Intel Core processors integrate an Intel HD Graphics Controller
4600 with up to forty powerful graphics units. According to the
manufacturer, a 3D performance increase of up to 60 percent,
as compared to the predecessor type, has been achieved.
There is also an improvement in the accelerated coding and decoding of high-resolution video data. Thanks to a new multiformat codec, MPEG, AVC, VC1 and Scalable Video Coding (SVC)
are now supported. Three independent displays can be
»
Company Profile
HiTek Power is an experienced world leader in
the design and manufacture of High- and
Low-Voltage Power Supplies for medical,
analytical instruments and scientific analysis.
HiTek Power
Germany
Johann-Friedrich-Boettger-Str. 21
63322 Roedermark
Phone: +49 6074 692850
Fax: +49 6074 6928510
sales.de@ hitekpower.com
www.hitekpower.com
Our High-Voltage product range includes
power supplies for Mass Spectrometry,
Capacitor Charging, Electron Gun, Ink Jet
Printer, Ion Pump apps, Intense Pulsed Light
(IPL), PCB Mount HV DC-DC, Photomultiplier,
Precision Scientific Instruments, X-ray and Ion
Implanting. Although the term medical can be
applied to many applications. Apart from
HiTek Power’s standard range, we have
designed a number of integrated instruments
including capacitor charging supply, rapid
discharge and pulse forming networks.
The Low-Voltage range of products has
output power ratings that range from 1W up
to 1200W with output voltages of 3.3Vdc up
to 60Vdc. All medical AC/DC units have been
approved in accordance with IEC 60601-1 3rd
edition and some of them can be delivered
with digital interfaces. Apart from this, HiTek
can provide a wide range of DC/DC converter
modules (1W up to 1kW). HiTek Power has
achieved its excellent reputation in the power
conversion industry by a varied range of
standard products and custom-built power
supplies.
HiTek Power’s extensive range of both
modular and rack-mounted X-ray power
supplies starts at just a few Watts up to 2kW,
with voltages available up to 100kV. X-ray
Power Supplies are available with a built-in
filament power supply and all X-ray products
have been designed with tube arc protection
and the interlocks required for X-ray applications.
39
MED Electronics Embedded Modules
time-to-market of the complete system can be considerably
optimized.«
The powerful C6B-8S COM Express Type 6 module family from
MSC integrates an 4th Generation Intel Core processor (Figure
3). The available modules are based on the Intel 8-Series platform controller hub (PCH) QM87 and currently offered with five
different processors. The Intel Core i7-4700EQ quad-core processor with 6 MB L3 cache is clocked with 2.4 GHz, or 3.4 GHz in
turbo boost mode. The thermal design power (TDP) is 47 W and
can also be limited to 37 W by its configurable TDP feature. The
processor supports the Intel AMT 9.0 Technology, Intel 64, the
Intel Virtualization Technology, VT-d Virtualized I/O and Intel‘s
Trusted Execution Technology.
3 The powerful C6B-8S COM Express Type 6 module family integrates an 4th Generation Intel Core processor
»
controlled. Even 4K resolution with up to 3840 x 2160 pixels via the digital DisplayPort interface and 4096 x 2304 pixels
with HDMI is now possible. This opens up new areas of application in the imaging sector. The integrated graphics unit complies with the latest versions of DirectX 11.1, OpenGL 4.0 and
OpenCL 1.2.
Besides the CPU cores, the high-performance arithmetic
units of the graphics controllers can be used for simultaneously running floating-point, vector and image processing
tasks. This is possible thanks to a uniform programming for
various high-performance hardware architectures through
the vendor-independent, non-proprietary
programming platform
Highperformance Open Computing Language OpenCL.
arithmetics OpenCL is an open and royalty-free
programming standard maintained
by the Khronos Group. The OpenCL
specification consists of the language specification as well as
Application Programming Interfaces (APIs) for the platform
layer and the runtime. With OpenCL, the comprehensive
computational algorithms can be hardware-independently
accelerated.
How can this new processor technology be quickly and safely
used in image processing systems? According to Wolfgang
Eisenbarth, Director Marketing Embedded Computer Technology at MSC, the answer is standardized, high-performance
Computer-On-Modules (COMs). The processor modules offer
the most modern standard PC functionality and are easily
mounted onto a baseboard that implements all the application-specific functions. The modules offered meet defined
standard specifications regarding form factor and performance, and are available in a range of different versions with
scalable processor performance. Wolfgang Eisenbarth: »This
allows a significant reduction of development complexity and
Fast dual-channel DDR3L (1333/1600) SDRAM modules with a
maximum storage capacity of altogether 16 GB can be plugged
in. An Infineon Trusted Platform Module offers a hardware
based security functionality according to the Trusted Computing Group (TCG).
The high-end modules have a comprehensive display support
offering three DisplayPorts 1.2 with multi-stream support or
HDMI digital display interfaces. The connection of three independent displays is possible. Furthermore the module has two
embedded DisplayPort interfaces, along with a LVDS and CRT
interface. With COM Express Type 6 pin-outs, the C6B-8S module family feature four fast USB 3.0 and four USB 2.0 ports. The
board offers seven PCI Express x1 channels, a PCI Express
graphics (PEG) x16 interface for powerful external graphics
cards and an LPC bus for legacy I/O interfaces. In addition, Gbit
Ethernet, HD audio and four SATA interfaces at up to 6 Gb/s are
available.
The platform runs under the Microsoft Windows 7, Windows 8
and Linux operating systems. The UEFI firmware Aptio from
AMI is used as BIOS. Starter kits and carrier boards ensure a
quick evaluation of the COM Express modules. In addition to
the embedded modules, optimized cooling solutions like a
passive and an active heatsink are offered.
The 4th Generation Intel Core processors set new standards for
embedded modules used in applications that require the highest level of performance. In particular, complex data processing tasks and 3D image processing show impressive results.
The C6B-8S module family is in various performance and price
classes available, for example, with different Intel dual-core
processors. Wolfgang Eisenbarth
is Director Marketing Embedded Computer Technology
at MSC Technologies.
[email protected]
40
Company Profile
» Embedded Technology for Medical Solutions «
Application ready Platforms for premium Medical Solutions
Kontron AG
Germany
Oskar-von-Miller-Straße 1
85386 Eching
Tel. +49 8165 77-777
Fax +49 8165 77-219
info@ kontron.com
www.kontron.com
Customers can reduce time-to-market and
use their resources efficiently
Kontron is a well experienced partner for
medical OEMs. Offering application ready
platforms and value adding services Kontron
enables its customers to create sustainable
and viable medical solutions.
Kontron products are found in applications
throughout the industry including imaging,
patient monitoring, diagnostics, therapy,
tele-health, proactive health as well as clinical
IT. Kontron understands the extensive and
evolving requirements of the medical equipment industry. Medical OEMs can rely on the
best service possible. This includes a highly
qualified Program Management and system
design expertise as well as environmental and
agency test experience and optimized logistics
and production up to an extended lifecycle
management.
Benefits at a Glance
W Long-term availability through extended
Product Lifecycle Management
W High reliability and state of the art quality
assurance
W Tailor-made solutions optimized for individual applications
W Reduced time-to-market with access to
latest technology
W Reduced R&D costs through comprehensive
value adding hard- and software services
Longevity & Lifecycle Management
Kontron offers availability for boards and
platforms up to 7 years, and even longer on a
41
case by case basis. A careful design and
vendor approval approach as well as scheduled
reviews, minimize unwelcome surprises
during the product life.
Quality Assurance through Certifications
In addition to ISO 9001:2008, many of
Kontron’s products and custom designs
have been EN 60601-1 certified alongside
the industrial environmental standards.
Custom Product Realization
For applications where off the shelf products
don’t quite fit, Kontron offers semi- and
full-custom designs tailored to the individual
demands of the application. With 40% of
Kontron’s employees dedicated to R&D and a
broad range of design capabilities, Kontron
develops the products and provides the
services to realize customized solutions
including individual logistic concepts.
Leading in Innovation
Kontron is supporting all major processor
platforms while also establishing global technology standards to be able to offer optimized
embedded solutions for individual applications
and reduce OEM’s time-to-market.
Value adding Hard- and Software Services
Kontron’s extensive OEM business experience
supporting long lifecycles, software services
and supply chain capabilities enables customers to focus on their core competences
differentiating themselves from their competition.
MED Electronics ATX Mainboard
In operating theatres, various tools for planning, navigation,
and imaging need to be controlled along with traditional light
boxes for X-rays and office software. But in terms of usability,
less is more in this case.
Intuitive Control
Via Touch Screen
B
efore and during an operation, doctors and nurses access a wide range of data. It is necessary to check the
patient’s data in the medical information system (MIS),
to extract meta data about the operation that is being prepared, to assess documents from preoperative diagnostics, or
to analyse X-rays from the picture archive (PACS). Monitors can
show live video data from an endoscopy, and video conferencing or telephony make it possible to consult with colleagues
during surgery. The whole operation can be documented and
archived by means of screen shots or video recordings. However, interacting with so many different systems across several
user interfaces in the operating theatre disrupts the work flow,
and as a result of this complexity, many interesting technical
functionalities remain unused. A user-friendly, intuitive concept based on a centrally controlled core unit is set to solve this
problem.
42
In terms of integrating systems in the operating theatre, there
is a trend towards IP-based network infrastructures. Users
need well-arranged control elements that can easily be customized to fit the work flow in the operating theatre. This
means that data which are relevant from a medical point of
Figures 1+2: Brainlab AG; Figure 3: Fujitsu Technology Solutions
1 By navigating the 42-inch touch screen with multi-touch and drag & drop functionalities, doctors gain quick and easy access to patientrelated image data from MRI and CT scanners, X-ray machines, or PETs and are also able to combine them
2 Intelligent algorithms make it possible
to augment patients’
image data with additional information,
such as a three-dimensional view made from
layer data, merely
planar in origin, that
were sourced from a
CT scan
a tool for neurosurgery marks out tuview need to be accessible through a unified
Contact
mors; and a computer-aided tool for rainterface. Therefore, Brainlab have reduced
dio therapy helps monitor the radiation
the complexity in the operating theatre by
Fujitsu Technology
Solutions
GmbH
dose.
intelligently interconnecting elements, deD-86199 Augsburg
vices, systems, and medical aspects as well as
Phone +49 (0)821 8040
During the operation, this information
infrastructural functionalities. The result of
Fax +49 (0)821 804-83177
can be shown on up to eight monitors so
this development is called Buzz, a system
www.fujitsu.com
the whole surgery team has access to it.
geared towards user-centric integration. This
For example, a screenshot could be
means that no matter what systems are intershown on the first monitor, a video reconnected, the user always works with the
cording of preoperative diagnostics on the second, and an Xsame interface on a 42-inch touch screen. The touch screen
ray on a third monitor. Simultaneousserves as the central point of control in the operating theatre
ly, the central screen may show a live
and enables clinic staff to quickly and easily access images,
Keep the team
video recording of the operation. A
video, and patients’ files using multi-touch and drag & drop.
click on the touch screen creates informed
Doctors can navigate within the images or switch between difscreenshots or video recordings from,
ferent takes and angles. With just one finger, doctors browse
say, the video signal of the endoscope. Image data gathered
through the image files in all directions, with two fingers they
during operations are documented and archived in ways that
can zoom in or out on certain picture details (Figure 1). Imagdiffer widely from clinic to clinic. The Buzz system offers semies from various sources can be overlaid quickly and easily.
automatic systematisation and archiving features which facilitate data management. The system allocates the image data to
A software solution for viewing all image data before the opthe respective patients and transfers all relevant patienteration facilitates diagnostic briefings and therapy planning.
Using the touch screen, patient-related image data from MRI
and CT scanners, X-ray machines, or PETs can be accessed and
combined by doctors. Intelligent algorithms make it possible
to extrapolate, augment, process, and interact with these visual data. For example, planar layer data from a CT scan can be
extrapolated to create a three-dimensional display (Figure 2).
These three-dimensional data are helpful in making therapeutic decisions and can also be used for clearly explaining
an operation or an illness to the patient. Different
software solutions are available for various medical disciplines. In orthopaedics, digital templating
assists the surgeon in adjusting and placing implants;
»
3 The ATX board offers a wide range of connections and delivers the
high computing power required for imaging during video processing and
simulation
43
MED Electronics ATX Mainboard
»
related image data to the hospital’s own PACS or any one of
the clinic’s storage servers for documentation and archiving
purposes.
In the operating theatre as such, IP-based communication with
other devices is possible. After bidirectional communication has
been set up between Buzz and a hospital PC in the operating
theatre, the whole system can be controlled from the hospital
PC, or from a tablet, and information from the PC can be visualized on the screen for all to see. Buzz offers seven video inputs
(analogue and digital), two video channels in HD quality, plus an
integrated sound system with iPod dock, speakers, and a volume control switch for the operator’s individual choice of music.
Continuous 24/7 operation is enabled by the Fujitsu D2778-D
mainboard. The ATX board is based on the Intel-X58-/-ICH10R
chipset. The board delivers the high
Protect your computing power required for video
investment processing or simulation thanks to the
support of its Intel Core Microarchitecture processors with LGA1366 socket,
integrated storage controller, and Intel Quic Path Interconnect
technology (QPI).
cause changing the board usually causes a series of design
changes regarding several interfaces. »In the case of the Buzz
system, such a new approval could easily cost several hundred
thousand euros,« explains Birkenbach.
Longer product lifecycles require suppliers to keep their components available for a long time. Furthermore, customers
need to be informed as early as possible about plans for changing or discontinuing any components so they can take appropriate steps. It is in the interest of industries with a strong emphasis on research, such as medical engineering, that Fujitsu
does not develop a mainboard for every possible chipset, but
instead chooses platforms, regardless of their manufacturer,
that make sense for the target markets.
Buzz also required system and USB architectures that are reliable and not too complicated. Fujitsu lent Brainlab a sample
mainboard, as well as testing software for tests under stress,
and BIOS tools, which enabled Brainlab to convince themselves
before placing an order.
The Trusted Platform Module (TPM1.2) by Infineon ensures
professional data security and encryption functionalities. Beside its six external USB connections and two internal Dual USB
pin headers, the mainboard also offers an onboard USB conRainer Birkenbach, Executive Vice President of Brainlab, connection, protecting licensed dongles or other data storage mefirms: »In our comprehensive tests, we put a particular focus
dia carrying sensitive information from theft, loss or mechanion the mainboard’s system stability and behaviour under
cal damage. The board manufacturer develops and produces
stress. Since the industrial mainboard is designed for continuthe mainboards in Germany, which ensures close cooperation with customers
in addition to a strict lifeFor this application,
cycle management.
the mainboard needs to
»
operate reliably in
continuous service«
For similar applications,
Fujitsu have meanwhile introduced the long-term
Rainer Birkenbach, Executive
availability ATX mainboard
Vice President at Brainlab
D3128-B with its Intel C602
chipset (Figure 3). This
chipset supports the Intel
ous operation, we did not meet with any problems here. In the
Xeon E5-26xx and E5-16xx processor families as well as the Inmedical field, long-term availability of a mainboard is also
tel Core i7 processors 38xx and 39xx. The 3128-B offers eight
extremely important. The time frame for the development of a
DIMM sockets with ECC support (DDR3-1600) as well as two
product plus the actual product life cycle in which it is sold is
third-generation PCI Express x16 slots. Further onboard feabetween three and five years. Due to this, we would face enortures include 5.1 multi-channel audio, USB 2.0 and USB 3.0,
mous additional costs if we had to design in a new board durIntel GbE LAN with iAMT 7.1/vPro support, Serial ATA III & RAID
ing the development phase.«
and BIOS-POST/Boot & OS-HW Watchdog.
Long-term availability plays an important role in medical engineering because electric devices for medical use are subject to
the regulations of the EN 60601 series of standards. For this
reason, the approval process preceding the market launch of a
new product is long and costly. If core components such as the
mainboard are changed during the lifecycle of a product, the
product must go through the whole approval process again be-
Peter Hoser
is Director OEM Sales at Fujitsu Technology Solutions.
[email protected]
44
Company Profile
RECOM Electronic GmbH
Reinforced DC/DC Converters with 3rd Edition IEC-60601
RECOM offers a wide range of DC/DC converters that are certified to the stringent
requirements of the IEC/EN 60601 – Medical
Equipment standard.
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
The product portfolio includes fully certified
DC/DC converters with a power range from
0,25 W up to 15 W. For example the RAM (1 W,
unregulated), RAZ (1 W, regulated) and RTM
(2 W, unregulated) series, offer an isolation
voltage up to 4 kVDC and an operating
temperature range up to 100 °C. For higher
wattages the regulated converters of the
series REC10 (10 W) and REC15 (15 W) are
suitable. They achieve efficiency up to 87%
and can be used in ambient temperatures of
between – 55°C and +71 °C.
are isolated up to 10kVDC and come in a
standard DIP24 case. For all RECOM 3rd Edition
Medical converters the ISO-14971 Risk Management files have been completed, which are
necessary for the successful certification of
the final product.
Company Profile
Driven by Innovation & Quality
As a partner to a wide variety of industries,
our product range is synonymous with
reliable high-quality 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
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
10 kVDC 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 6 W power rating,
45
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!
MED Prostheses Plastics Processing
Polymer-Based
Load Bearing Implants
L
arge artificial joints for hip, knee or shoulder are load
bearing implants and are manufactured from various
material combinations such as metals, ceramics and
plastics. Ultra-high-molecular-weight-polyethylene (PE-UHMW)
performs the task for the articulating surface which means
PE-UHMW is the slide surface to metallic or ceramic components of ball and hinge joints. Today, a range of different polyethylenes is available, some of which might contain additives
such as vitamin E or may be cross-linked by gamma irradiation. Polymers from the group of the polyetherketones (PEK)
are used for the spine, as well as metal. Plastics allow surgeons to follow the successful healing without X-ray shadows. Additionally, mounted X-ray markers permit recognition
of the location of the plastic implant. These markers are made
of X-ray absorbent materials such as titanium or tantalum.
Machining of plastics made of bar stock and pressed material
is most commonly used. An as low as possible surface roughness of the sliding surface is crucial for the initial abrasion of
a prosthesis. Post-processes such as polishing might achieve
a nicer looking visual surface quality. However, they damage
the surface of the part which causes adverse effects by later
mechanical stress.
Not all materials suitable for implants are available as semi-
finished materials. Gsell therefore manufactures blanks by
injection molding and finishes them by machining. It is an interesting solution in economic terms. Materials for implants
cost a great deal more than materials for other applications.
The investment may be worthwhile since it reduces the
amount of material that needs to be machined. A lot of experience is necessary in mold design and in the injection molding process, as the blank part design might not be fully appropriate for plastics. Furthermore, PEKs are high temperature
polymers which accordingly require high processing temper-
46
All figures: Gsell Medical Plastics
Joint implants make patients
pain-free, restore mobility
and increase thereby quality
of life. Plastic implants play an
increasingly important role.
They allow to observe the
healing process without X-ray
shadows. However, manufacturing these implants requires
a lot of experience.
1 Hip cup of a cemented prostheses made of polyethylene
2 Spinal implants, so-called spine cages,
made of PEEK get visible during X-ray by the
use of X-ray markers
atures. A d
edicated injection molding
infrastructure is also needed.
Medical devices are moving within a regulatory framework which gets tighter and
tighter. The administrative effort for the
manufacturing of these products is greatly increasing. Customers are more and more frequently asking for single-source solutions for the
manufacturing of prosthesis made from several materials
such as titanium or polyethylene. Due to incidents with implants for plastic surgery, the EU commission is working on a
more stringent medical device regulation. It is intended, for
example, to upgrade the medical device classification of
spine implants from class IIb to III.
Only the resilient quality management system of an experienced contract manufacturer is able to deal with these challenges. Gsell has been manufacturing plastic implants for over
25 years. During this lengthy period, not a single recall has
been made. This speaks for the constant high quality of validated processes of an experienced OEM supplier and especially
applies to the increased manufacturing complexity of implant
assemblies made of various material combinations.
Contact
Gsell Medical Plastics AG
CH-5630 Muri
Phone +41 (0)56 6754040
Fax +41 (0)56 6754041
www.gsell.ch
Custom Miniature Microscopes
• Multi Wave Length Fluorescence
• Contrasting Techniques
• Laser Integration
Solutions in Optics - Reduced to your Needs
www.opto.de
47
MED Prostheses Titanium Saw
For optimum results in terms of economy, precision, and operator’s safety when working with titanium Forginal Industrie
uses a high-performance circular saw.
Sawing Titanium –
the Ultimate Challenge
O
ver a million implants produced for France’s orthopaedic industry make for an impressive reference. With a
workforce of around 100, last year the company situated between Clermont-Ferrand and Lyon generated an annual
turnover of 15 million Euro. From the planning stage through
implementation to surface treatment, the company performs
the whole range of processing stages in-house. By dispensing
with subcontractors, it guaranties high confidential project engineering. »The research and development of new prosthetic
devices is a sensitive issue, which is why all the data concerning
any new development remains firmly in our hands«, explains
Head of Production, Michel Cieslak.
Titanium is biocompatible and has been used extensively in
medical technology applications over many years in both alloyed and unalloyed form. »Hip, knee, shoulder or vertebrae
replacements are made of titanium, as are fixing materials for
bones such as nails, screws and plates«, continues Cieslak.
Pacemakers or instruments for cardiac and eye surgery are also
made of titanium. The HCS 70 high-performance circular sawing machine from the Baden-Württemberg based manufacturer Behringer has a valuable role to play in machining this tough
material. It is mainly used to saw grade TA6V4EI round titanium
stock and stainless steel in different grades up to diameters of
60 millimetres. »Sawing technology is the preferred choice for
Contact
Behringer Eisele GmbH
D-73235 Weilheim/Teck
Phone +49 (0)7023 957570
Fax
+49 (0)7023 95757-80
www.behringer.net
Forginal Industrie S.A.
Chemin de la Varenne
F-63306 Thiers
Phone +33 (0)473 8030-89
Fax +33 (0)473 8042-33
www.forginal.com
1 The high-performance circular saw
HCS 70 cuts small and
medium size series
from 50 to 30,000
pieces per month
48
the innovative cooling system using different cooling media,
this system offers sufficient reserves for future saw blade developments. Forginal Industrie uses specially coated two millimetre thick blades. »This saves us valuable material and of
course time too«, comments the
Head of Production. »With our Standard saw for
small and medium-sized pro- special applications
duction of between 50 and
30,000 units per month, the
tooling costs are quickly recouped.« The different drop forged
titanium blanks processed have piece weights ranging from
10 grams to 10 kilograms. Another special aspect: As the GO
parts are destined for use in the human body or in surgical procedures, they are not permitted to come into contact with industrial oils during the machining process. »This is why we use
only CQ16 and CQ33 vegetable oils for lubrication«, explains
the Head of Production.
2 Round titanium parts used to manufacture implants
our machining requirements. We require finish cuts with an optimum surface quality, eliminating the need for finishing processes, and compliance with extremely precise tolerances.
There are hardly any sawing machine manufacturers able to
meet all these requirements«, states Cieslak.
Titanium has minimal elasticity. Its tenacity causes extreme
levels of heat to develop during the machining process. This
poses a challenge to any sawing machine. »The solution is to
precisely tune the sawing process to the material«, explains
Manfred Grüninger, Head of Sales at the circular saw manufacturer. A constant forward feed rate, effective cooling and a specially adapted cutting speed make for optimum cutting results.
The HCS 70 is configured for workpiece diameters of up to 75
millimetres of solid material. With a speed range from 25 to
215 rpm as standard, the machine allows almost unlimited
scope for application even with the basic equipment package.
The saw drive system uses a proven combination of durable,
play-free helical worm gear and frequency controlled main
drive. Combined with the saw shaft’s precision servo drive and
After more than one year of reliable operation, Forginal endorses Behringer Eisele’s manufacturing philosophy of producing economical machines with added emphasis on extending the service life of costly tools. »They guaranteed that we
would be able to produce around 3000 cuts with one saw
blade. Currently we are up to 7000 cuts with one and the same
blade«, enthuses Cieslak. »Which means our expectations have
been well and truly exceeded!« After many months of reliable
operation, the French market leader is happy to give the HCS 70
top marks. The key requirements of cutting quality and cutting
times have been delivered in full. Production in general is also
up, and the required buffer to compensate for bottlenecks and
reduce time pressure has also been implemented. Production
costs have been significantly reduced and superfluous work
steps eliminated. Importantly too, the team at Foriginal appreciates the robust, compact closed design of the saw with its
generous viewing windows and easy accessibility for cleaning
and maintenance. The provision of servicing and support in
French also helped speed up proficiency and familiarization
with the new machine.
Global Brands
trust Zwick.
Intelligent Testing.
www.zwick.com
Please visit
us
tv
ZwickRoell.ng
sti
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Testing Systems
49
New Products Micro Camera
Small HD camera head and high performance
Panasonic’s Industrial Medical Vision
division presents a micro camera series.
They are suitable for many applications
in the medical environmental (hospitals,
microscopy, endoscopy and dental) as
well as in life science. The remote head
cameras including the 1MOS GP-KH232E
and the 3MOS GP-US932X can be purchased in full or as OEM component.
Therefore, customers can build their
own medical camera solution. The GPKH232E camera series, consisting of the
Remote Head and the Camera Control
Unit, is ultra compact, yet does not
compromise on picture quality in terms
of resolution, sensitivity and color reproduction. It has a single chip CMOS
approach for high image quality and
new Digital Signal Processing resulting
in a small digital HD camera head with
standard C-Mount type lens interface. It
supports common HD & SD video formats from 1080p/50 (59,94) Hz to
576i/480i and achieves a horizontal
resolution of 900 TV Lines, with a required illumination of 2000 lx at F5.6.
The GP-US932X has high HD quality in
micro format for long distance with one
of the smallest remote 3-chip camera
head, digitized video signal and the
ability to use all common video formats.
Outstanding performance thanks to
improved sensors, a 1000 TV Lines
resolution and increased light sensitivity
of 2000 lx at F12 (Binning = ON). Functions or the camera are: image rotation
and mirroring options, three pre-sets
including the color temperatures,
freeze picture, 2.5x electronic zoom,
12-axis color matrix and frequencydepending detail enhancement. A flexible range of new block module zoom
cameras including the SD
modules GP-MS424 and
GP-MS436 as well as HD
modules GP-MH310,
GP-MH322, GP-MH326
and GP-MH330, which
range in their optical
zoom ratio from 10x to
30x are availabel too. Especially the new
range of single chip Full-HD module
cameras offer outstanding HD resolution and superior color reproduction at
the right size for a variety of professional video applications. They have
outstanding performance and deliver a
native resolution of up to 1080 pixel,
plus feature multi-format capability in
compact and light weight camera modules. Whilst latency time is extremely
low compared to similar cameras in this
category the modules also offer automated monitoring of scenes with high
image quality.
www.panasonic.net
Molex introduces its Balanced Armature Audio Receivers which
are perfect for the hearing-aid market. Measuring 80 mm3, the
receivers are supposed to provide up to 20 percent space savings versus
similar competitive products and up to 75 percent versus dynamic
receivers. The technology also offers substantially more sound output
Vacuum Pump
Special silencer reduces noise level. KNF’s
N 838.1.2 diaphragm vacuum pump is used for
medical technology applications, especially in
combination with suction devices. The pump has
compact dimensions and a high pneumatic
capacity. It transfers 42 l/min under atmospheric
conditions and achieves an ultimate vacuum of
90 mbar abs. The manufacturer has given special
attention to reducing the noise level when the
pump is operating: While the pump design itself is
exceedingly quiet, sound is reduced to a whisper
when the optional silencer is attached. The pump
is equipped with a patented stress-optimized
structured diaphragm, which results not only in
high capacity for such a compact pump, but also
increases the service life of the diaphragm. KNF
provides a comphrensive range of diaphragm
pumps for the field of medical technology. This
offering also includes DC-powered pumps used in
portable equipment for analytical and medical
technology applications. Higher transfer capacity
pump models are available for devices used to
suction body fat.
www.knf.de
sion manufacturing capabilities and audio business expertise, we provide audio OEMs with the ability to cost effectively design products half
the size of traditional hearing aids yet with superior sound output and
quality.« The new Balanced armature receivers are customizable, allowing OEMs to adjust the impedance or other specifications to meet specific requirements. Besides applications in hearing aids, these
balanced armatures can be used for Cardiac Rhythm Disease
Management (CRDM) devices too. Here they can also more efficiently transform energy into sound, helping to save or extend battery
life. In addition, the armatures are ideal for high-performing, small and
attractively-designed earphones.
www.molex.com
Customizable Audio Receiver
per unit size and cleaner mid-range sound compared to dynamic-style
receivers. »Many people who need a hearing aid don’t pursue getting one
because they think it will be a big, uncomfortable device,« says Anthony
Kalaijakis, strategic medical market manager. »By combining our preci-
50
DC/DC Converter
Meets IEC/EN 60601 3rd edition
RECOM offers a wide range of DC/DC converters that are certified to the requirements of the IEC/EN 60601 - Medical Equipment standard. They are suitable for a huge variety of medical
applications in which high isolation and low leakage currents
are required. The extensive product portfolio includes fully
certified DC/DC converters with a power range from 0,25 W
up to 15 W. For example the new RAM (1 W, unregulated), RAZ
(1 W, regulated) and RTM (2 W, unregulated) series, offer an
isolation voltage up to 4 kV DC and an operating temperature
range up to 100°C. For higher wattages the regulated converters of the series REC10 (10 W) and REC15 (15 W) are suitable.
They achieve efficiency up to 87 percent and can be used in
ambient temperatures of between −55 and +71°C. Whenever
patients come directly into contact with electricity, special
protective measures are required. The R-series has a specially
designed reinforced isolation transformer core and new insulation materials to ensure that not only the 3rd Edition of the
IEC-60601 required clearance and creepage distances are
observed, but also higher isolation voltages of up to 10 kV DC
can be guaranteed. In addition, the interwinding capacitance
is reduced to between 1.5 and 20 pF. This leads to extremely
low leakage currents, also a common requirement for medical
applications. 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 (1 and 2 W respectively) are
isolated up to 8 kV DC 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 effi-
Brain Stimulation
EEG
Smart Implants
Hearing Aid
Cardiac Monitoring
Myostimulation
Fall Sensor
Body Area
Respiration
Monitoring
Imaging Systems
AEMtec GmbH
Urinal sphincter
ciency is close to 88 percent − so the ambient operating temperature can be up to +85°C with convectional cooling alone
and without any derating.
The REC3.5 and REC6 series have 3.5 and 6 W power rating,
are isolated up to 10 kV DC and come in a standard DIP24
case. They have an approximately 20 percent higher power
rating than their counterparts with standard isolation and
reach efficiencies up to 86 percent. The maximum ambient
temperature is +85°C for the REC3.5 with natural convection
cooling and without derating. The more powerful REC6 works,
up to +75°C under the same operating conditions. For both
series the case temperature can reach +105°C. For all RECOM
3rd Edition Medical converters the ISO-14971 Risk Management files have been completed, which are necessary for the
successful certification of the final product.
www.recom-electronic.com
We provide miniaturized
electronics for
improved life quality
From ideation to series production
Supporting class 1 to 3 applications
Individual counseling and support
Micro assembly & packaging for sophisticated devices
Clean room production up to ISO 5
Clinical Regulatory Support
Qualified execution according to ISO 13485, 14971,
EN 60601
Implanted Movement
Monitoring Systems
www.aemtec.com
Materials Interview
Defining the Art
of Silicone
MED: Helix Medical is known for silicone and thermoplastic
medical components. What are the trends that you see
coming?
Kley: Basically we see two big trends – one in silicone manufacturing and one in surface modification. In order to produce
high-quality silicone products we exclusively use platinum
catalyzed medical silicones. Talking about surface modifications there are several possibilities to adjust components to
individual customer requirements. Friction reduction or antimicrobial coatings are gaining more and more importance.
Antimicrobial materials, miniature multi-lumen tubing, catheters for neurovascular applications and individual surface
modifications through plasma
treatments – silicones and thermoplastics can be uniquely customized. Dr. Max Kley of Helix
Medical Europe explains the art
of customizing these materials.
MED: What are the advantages of platinum catalyzed silicones?
Kley: With platinum catalyzed silicone you don’t need to worry
about the emission of peroxide. During the manufacturing of
platinum catalyzed silicone moldings and tubing there are no
by-products contaminating equipment and finished goods.
MED: Does this help making production processes cleaner?
Kley: That’s right. In fact it is state of the art, but some stay with
MED: Where do you use antimicrobial coatings?
Kley: One example is our voice prosthesis. One division of the
Helix Medical Group called InHealth manufactures OEM products for patients after laryngeal resection. Those patients regain their ability to talk after a valve is implanted into their
larynx. This valve must be changed regularly. Using an antimicrobial coating the emergence of a bio film can be held up and
exchange intervals become longer.
MED: Can coatings wear off after a certain time?
Kley: Depending on the surface treatment process and the application surface coatings can wear off quickly or last for years.
If a coating’s only use is friction reduction during the assembly
process the effect may wear off quickly. Other surface treat-
ments that are meant to reduce friction on a longer term can
stay for years. If you modify a part’s surface itself instead of
coating it the effect might last the component’s life time.
MED: How important are coatings with active pharmaceutical ingredients?
Kley: At our Vistamed facilities in Ireland we are manufacturing
products with active agent coatings. At the moment we are investigating the potential for additional applications and further
developments.
MED: What makes the difference: raw materials or production processes?
Kley: In our markets we are limited to the raw materials that
have the certifications for medical and pharmaceutical applications. Differentiation is possible by efficient and innovative
processes and attractive value-added services, e.g. surface
modifications, which help create tailor-made solutions. Nevertheless we are also working on innovative materials for medical
applications. But the certification of new materials is a long
process.
52
All photos: Erika Fuchs, CHV
peroxide silicones because they want to avoid the change procedures. We are exclusively using platinum catalyzed silicones
for all our products from tubing to precision molded parts,
from implants to other medical components. If peroxide silicone is used there always will be by-products remaining in the
production and storage equipment. Helix Medical has never
used peroxide silicones – so the cleanliness has been guaranteed from the beginning.
» Our tubes for hearing aids
have a diameter of 0.2 mm.
For silicone tubing this is almost as small as it can get.
But we are still working on
products with smaller diameter and wall thickness.«
Dr. Max Kley, President Helix Medical Europe
MED: Helix Medical
Contact
offers a patented
surface modificaHelix Medical Europe GmbH
D-67661 Kaiserslautern
tion technique comPhone +49 (0)631 5341-7500
parable to plasma
Fax +49 (0)631 5341-7600
treatments. What is
www.helixmedical.de
the difference in
comparison to common methods?
Kley: Both the process itself and the effect on the material are
different from conventional plasma treatments. We created
our technique especially for critical applications such as medical and pharmaceutical environments and achieved less interfering results than with common plasma methods.
MED: What are the benefits of these plasma etched molded
parts?
Kley: We see an interesting potential for plasma etched molded
parts – especially for silicone moldings with low shore hardness
which have a tendency to sticking effects. The part’s surface
can be selectively modified by plasma etching which is beneficial for e.g. automated assembly lines. There will be fewer disruptions because of sticking silicone parts. This is very important for high-volume mass production applications. Also
transportation can be made easier or parts can become oil or
water repellent.
MED: Besides materials miniaturization is an important topic in the med tech world. Do you see further
development in this area?
Kley: Concerning miniaturization we see strong growth
of demand for neurovascular applications for instance. There
are numerous innovations which demand miniature components. Being development partner of innovative high-quality
solutions this is an interesting field of development. Materials
and production process set certain boundaries but we still see
potential to push the bar. Today we manufacture implantable
tubing with a diameter of only 0.2 mm. For silicone tubing this
is almost as small as it can get. But we are still working on products with smaller diameter and wall thickness. A second impulse for innovation is the customers’ demand for more functionality on smaller space. We offer multi-lumen tubing to the
market which facilitates catheter systems with additional functions. The space these functions will be placed into becomes
smaller and smaller. And again we work on pushing the bar
even more.
MED: Where do you see more potential for new developments – at the material or the process side?
Kley: We see potential on both sides. But remarkable progress
is most probable with a combination of both. The advantage of
the Helix Medical Group is that we cover the entire value chain
from research & development to manufacture and assembly of
complete minimally invasive systems. For instance we offer development consulting and support by our subsidiaries Vista
med and MedVenture. By understanding the architecture of
components and devices combined with our expertise in
manufacture and material science we facilitate new func-
»
53
Materials Interview
» Remarkable progress
will most probably be
achieved by combing improved materials with optimized processes.«
Dr. Max Kley, President Helix Medical Europe
»
tionalities. Being part of the Freudenberg Group we have
access to the most powerful research & development entities
which have been bringing innovations to the elastomeric and
thermoplastic fields for over 80 years and offer the most modern analysis techniques.
with rapid prototyping. Here again we have the big advantage
of being part of the Freudenberg Group. In cooperation with
our partner company Freudenberg Merkel we can offer prototypes and sealing components in small numbers within a
matter of days.
MED: Are you working on a new miniaturized product?
Kley: Absolutely. Our subsidiary Cambus Medical in Ireland
MED: Is this the production process of the future or maybe
manufactures precision hypo tubes for sophisticated catheter
systems. The colleagues are working on products with an extremely thin wall thickness yet high flexibility. The challenge is
to develop the thinnest hypo tubes possible that won’t break in
its application.
MED: How long does such a development process take?
Kley: A complex project with different parties involved and approval procedures to be run through can easily take nine
months up to several years.
MED: Do you use simulation models?
Kley: We have a simulation and testing facility with excellent
equipment in Weinheim, Germany. There we can for instance
simulate the influence of different design alternatives as a
function of different material characteristics for our voice prosthesis using FEM. Tubing can also be an example. If the targeted properties are known we can simulate the tubing and find
the ideal combination of materials.
MED: How important is Rapid Prototyping during a development process?
Kley: We have several development projects which we support
something your customers could introduce to their own
facilities?
Kley: For high-volume molded parts this stock-removing technique is not the method of choice. At our MedVenture division
we use 3D printing technology during the development phase
to manufacture entire catheter modules. In mass production
materials and applications play an important role. Many materials which can be used for rapid prototyping are not applicable
or do not show the necessary properties required by medical
applications. Today rapid prototyping only allows a limited
view on the final system. Certain functionalities can be tested
but is an adequate product. In our markets 3D printing technology cannot yet replace traditional production methods in a bigger scale.
MED: You already mentioned companies you acquired
uring the past months and years. What is the intention
d
behind that?
Kley: Today Helix Medical is one of the leading companies in
manufacturing medical components. It is our aim to also become the preferred development partner and service provider
for our customers developing complex medical devices. We
will offer the complete value chain from material expertise to
final assembly – but always in cooperation with a customer.
54
MED: Do you consider Asian suppliers as competition?
Kley: We see Asia as a big opportunity for us. The Asian market
shows a growing demand for high-quality components and
even complete devices. We are currently studying how we can
expand our presence and activities in China. Regarding Asian
components suppliers on the European and American markets
we do not yet see an intensification of the yet high competitive
pressure. As to liquid silicone molding the leading tool builders
are all based in Western Europe and the United States. It is difficult to find equivalent support in East Asia. The infrastructure
is not yet set up sufficiently.
MED: What will bring the Freudenberg Group forward in the
medical markets in the next five years?
Kley: We have been growing considerably in a very demanding
environment. The Freudenberg Group is soundly financed and
possesses the necessary means to expand in the medical industry. The medical field is one of our target markets for sustainable growth. We will grow organically at all our sites. Furthermore we keep our eyes open when it comes to acquisitions.
MED: Where do you see your biggest market opportunities
the European market since. Due to its strong market position
Helix Medical still has solid potential to grow in the American
market. Also Asia and Latin America are very interesting markets for us. In Costa Rica we have a production site in the leading outsourcing area of American medtec companies.
MED: Regulatory conditions play an important role in the
medical world. How do you evaluate the draft of the new
European directive?
Kley: As a component supplier we are following this development very attentively and with a certain anxiety. We see the
threat of an overreaction. The key point will be whether the
European regulatory system can preserve its advantage

regarding reactivity and flexibility for innovations and de

velopments.
MED: Could the European medical industry thwart itself?
Kley: Absolutely. But in addition to that it still has to be possible
to bring innovations to market for the sake of the patient.
MED: Which are the positive aspects of the new directive?
Kley: I think a consistent execution of the existing legislation in
Kley: We see considerable potential for growth in Europe. We
the different countries of the European Union is a key factor. If
the new directive will achieve that, it would be welcome.
have set up our European headquarters in Kaiserslautern, Germany in 2009/2010 only and have been intensively working
MED: Thank you very much for the interview, Dr. Kley.
in the years to come?
Company Profile
Colder Products Company
Colder Products
Company
Germany
Colder Products Company GmbH
Schmalweg 50
55252 Mainz-Kastel
Phone: +49-6134-2878-0
Fax: +49-6134-287828
China
Colder Products Company
Limited
Flat B, 29/F, West Gate Tower
7 Wing Hong Street,
Cheung Sha Wan
Kowloon, Hong Kong
Phone: +852-2987-5272
Fax: +852-2987-2509
Colder Products Company is the leading provider
of quick disconnect couplings and fittings for life
sciences applications. Used in a broad range of
devices and equipment, innovative standard and
custom-engineered solutions for fluid and air
handling allow flexible tubing to be quickly and
safely connected and disconnected. Applications include reusable and disposable connection
devices for use with surgical and dialysis equipment or on blood pressure monitoring and
patient therapy devices.
Colder’s engineered solutions improve the
overall function and design of the equipment
and processes in which they are used. These
advanced coupling technologies improve OEM
manufacturers’ products with enhanced features
for increased patient safety and reduced manufacturer liability.
IdentiQuik® Series couplings integrate radio
frequency identification (RFID) to automatically
identify fluid characteristics, track device usage
or capture connection usage data before a
connection is made, to prevent connection
errors.
55
Hybrid Connectors allow fluid, air and electronics to be connected with one simple motion.
NS1 Series quick disconnect couplings are the
smallest plastic non-spill quick disconnect
coupling available on the market today. Available
for tubing sizes less than 3.2 mm, the connectors provide a truly closed system and a cleaner,
safer connection for small tubing diameters
where space is at a premium.
Colder Products, a Dover company, has direct
sales and distributor representation in North
America, Europe, Latin America, Australia and
Asia. Visit www.colder.com or email
[email protected].
Materials Customized Tubes
Many business contacts start with questions regarding the
price of a tube. Even if the inner and outer diameter are known,
in most cases it is not possible to make a reliable statement.
One Tube is Not
Like Another
Contact
Novoplast Schlauchtechnik GmbH
D-38820 Halberstadt
Phone +49 (0)3941 68690
Fax +49 (0)3941 6869-40
www.schlauchtechnik.de
B
asically it is easy to produce tubes in different dimensions. The basic ingredients are selected raw materials,
the right auxiliary materials, good tools and a lot of experience. But to offer customized solutions it is indispensable
to evaluate further particulars in advance:
++ application area
++ contact with media / chemical resistance
++ special requirements concerning physical values (e.g. pressure, UV-resistance)
++ degree of hardness in shore A or D
++ requested method of sterilisation
++ retention time in or outside of the body
++ specifics (multi-lumen or multi-layer tube)
++ packaging
These questions have to be answered for serial products as well
as for prototypes. A proper consulting is the basis for an effec-
tive product implementation. In most applications the tube is
only one element of a complex system or device. On the basis
of the available information the adaption of the tube in material, dimension and further parameters is made. Only in very
rare cases all the facts are previously completely known. For
example if the customer wants to achieve smaller tube dimensions by complex procedures like stretching or pulling, properties like tensile strength and reproducibility are the most important parameters because in this case traditional material
constants are not sufficient for the processing by extrusion and
pulling. The more specific the requirements are, the higher are
the influences on the processing parameters. In one project we
could reproducibly manufacture the tube with the requested
properties by the height of the melt temperature, the consistence of the melt and the specified cooling rate. It would have
been impossible to produce this tube with all desired features
56
All figures: Novoplast Schlauchtechnik GmbH
1 Special requirements concerning
physical values, as
requested in this
pressure tube may
pose a challenge
only by implementing and controlling the usual established
product parameters like the defined dimensions including the
corresponding tolerances or the surface structure.
Of course, there is also progress in the production of tubes.
The replacement of PTFE, FEP, plasticiser-free PVC-alternatives
and silicon by commercial thermoplastics are just a few examples. The departments Development and Pre-series are extensively concerned with new developments of materials and possibilities of modification. In close cooperation with our
customers we work out proposals and checked for suitability
from all points of view. Sliding friction coefficients similar to the
one of PTFE are even feasible with modified standard thermoplastics considering the friction partners. Meanwhile also very
soft materials can be manufactured economically into tubes as
alternative to silicone. Furthermore these materials partly possess even better mechanical properties and with regard to the
further processing they allow new possibilities like printing and
gluing of the tube.
In the past injection molding was often the first choice in the
manufacture of high lot sizes of thick-walled, short, rotationally symmetric components. Today we are able to produce precisely fitting parts by extrusion without high investment costs
which are in some cases unavoidable in injection molding. Besides the advantage of low tool costs it is also possible to make
changes in the dimensions and material during the product life
cycle. There is significant potential for protective tubes of all
kinds. It is possible to realize contoured inner and outer surfaces with reasonable tool costs. All productions lines at Novoplast Schlauchtechnik are provided with modern equipment
for the measuring of the relevant product dimensions. Furthermore we can perform optical inspections, strength and
chemical resistance tests. These kind of tests become impor-
2 Special processes
are applied to produce
multi-lumen tubes
tant (very often also in combination) especially in case of the
development of new products or further developments. For
the rapid transfer from the development to the series status
we can support our customers by these actions and assist them
for an enduring success of their products.
The company does not only focus on asking for the parameters
of the requested tube but also on research and consulting and
on extensive tests up to the molecular level. Developing tubes
there is much more to consider than it seems. First-class tubes
for specific applications are rarely to find in the well-known
catalogues. They are rather the result of the cooperation between customer and manufacturer and common development
steps.
Lars Graichen
is Project Engineer - Medical
Technology at Novoplast
Schlauchtechnik.
Andreas Hankel
is Business Unit Manager at Novoplast
Schlauchtechnik.
[email protected]
Lift 220 | 210x105 mm | 4c | +3mm Beschnitt
HEBEN SENKEN SCHWENKEN
HMA Lift 220
Inﬁnitely variable height adjustable suspension
arm with non-impact rotation and
integrated power supply
Loading weight
up to 21 kg
Component connection
via standard interface
Further product information: Haseke GmbH & Co.KG | Tel. +49 (0) 5731 / 7607 - 0 | www.haseke.com
Index / Masthead Advertisers / Index
Advertisers
A EMtec GmbH, Berlin
AWAIBA GmbH, Nürnberg
Micro-Epsilon GmbH & Co.KG,
Ortenburg3
51
31
B ICKER Elektronik GmbH,
Donauwörth25
Bühler Motor GmbH, Nürnberg 5
Bürkert Werke GmbH,
Ingelfingen9
C omité EPMT/EPHJ, EPMT, SMT2
CPC Colder Products Company
GmbH, Mainz-Kastel
55
E BV Elektronik GmbH, Poing
F aulhaber, Dr. Fritz,
7
47
Europe AG, Holzkirchen
Physik Instrumente (PI)
GmbH & Co. KG, Karlsruhe
19
G ardner Denver Thomas
11
H aseke GmbH & Co. KG,
Porta Westfalica
57
HiTek Power GmbH,
Rödermark39
J ohnson Matthey Catalyst
(Germany) GmbH, Redwitz 59
K ontron AG, Deggendorf
41
M axon Motor AG, Sachseln/CH 1
Micro Systems Technologies,
Baar / CH
23
15
R ecom Consulting GmbH &
Co. KG, Neu-Isenburg
Derendingen / CH
37
Stemmer Imaging GmbH,
Puchheim33
49
Index
A esculap8
ASCO Numatics
Axilum Robotix
Rex Bionics
12
Roesys20
F AULHABER16
Forginal Industrie
48
Freudenberg Group
52
Fujitsu Technology Solutions 42
22
SMC19
Streb & Weil
16
G ardner Denver Thomas
Gsell Medical Plastics
45
S phinx Werkzeuge AG,
Z wick GmbH & Co. KG, Ulm
GmbH & Co. KG, Schönaich 60
First Sensor AG, Puchheim
32
GmbH, Puchheim
O pto GmbH, Gräfelfing
P anasonic Electric Works
e bm-papst19
EU Commission
8
32
16
B . Braun group
H elix Medical
HiTek Power
Horizon 2020
33
47
52
25
8
K ARL STORZ
6
Khronos Group
38
Klinikum rechts der Isar
26
KNF50
Kontron34
L itronik Batterietechnologie
m axon motor
25
12
medAS26
MedVenture52
Molex50
MSC Technologies
38
MST Group
35
Micro-Epsilon Messtechnik
20
8
Behringer Eisele
48
BIOTRONIK6
Brainlab42
Bühler Motor
14
Bürkert32
N ovoplast Schlauchtechnik 56
P anasonic50
C ambus Medical
Physik Instrumente
CIM med
52
26
23
R ecom51
S chölly Fiberoptic
T Q-Systems28
U niversity Hospital of Wales
6
University Leipzig
6
V istamed52
Authors
Affeld, Dietrich
Bauer, Birgit
Eisenbarth, Wolfgang
Graichen, Lars
Hankel, Andreas
Hoser, Peter
Kley, Max
Loibl, Manuela
Oschwald, Helmut
Reiff, Ellen-Christine
Salzberger, Johann
Schütz, Anja
Seegen, Andreas
Seitlinger, Josef
Stary, Therese
Unrath, Jens
Zeiff, Andreas
21
24
40
57
57
44
53
27
26
24
21
13
18
26
31
36
18
Masthead
Short description
MED engineering is the trade journal for
designers and developers of diagnosis
and therapeutical devices for all
medical fields, including ophthalmo
logy, 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
Kerstin Gottscheber (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;
Prof. Dr.-Ing. Petra Friedrich, University
in Kempten, Germany;
Dr. Martin Leonhard, KARL STORZ;
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 Verlags
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© Carl Hanser Verlag, München 2014
HARNESS THE POWER OF
PIEZO TECHNOLOGY
TO SOLVE MEDICAL DEVICE MOVEMENT REQUIREMENTS
Piezoceramic– is a „smart“ material; it has the
capability to transform mechanical energy /
vibrations / sound waves, etc. into electrical
energy and, to change shape (becoming either
shorter or wider) when electric voltage is applied
to it. Piezoceramic is fast, precise, silent and
heat-free.
For more than 40 years, Piezoproducts, a
Johnson Matthey company, has harnessed the
power of the Piezo Effect to provide solutions
for actuator and sensor applications using
Piezoceramics and Piezo benders. Featuring a
lifetime of more than one billion switching
cycles, Piezo benders are easily modifiable to suit
the application. Complete systems with
Piezoceramic components, electronics and
mechanics can also be offered as customized
solutions.
Consider Johnson Matthey Piezoproducts when
designing solutions for bio-mechanics, bio-handling, precision medical device automation and/or
other modules within your medical device.
ADVANTAGES
 Compact size enhances miniaturization
 Low energy consumption
 No heat produced
 No electromagnetic noise
 Rapid positioning speed and frequency
 Non-conductive and non-flammable materials
 Silent operation
 Long-term durability and realiability
Johnson Matthey Catalysts (Germany) GmbH
Piezoproducts
Bahnhofstrasse 43
96257 Redwitz
Germany
T +49 9574 81 453
F +49 9574 81 98 453
[email protected]
www.piezoproducts.com
FAULHABER applications.
Technology
that gets under
your skin.
FAULHABER micro drives in tattoo technology.
Today, the ink for a tattoo is delivered to the skin with up to 7,500 punctures per minute.
For large, complex motifs, the artists nevertheless work on their creations for hours on end
without a break. They thus place high demands on their tool.
In addition to low-vibration and quiet operation, modern tattoo machines are characterised
by a compact, ergonomic design with low weight. For the drive solution, leading tattoo machine manufacturers rely on the know-how from FAULHABER.
WE CREATE MOTION
Further information at www.faulhaber.com/tattoo

Medical Devices - MED engineering

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