Around 600,000 pacemakers are implanted every year
worldwide. When they are supplied from the manufacturer,
the pacemakers come with default settings that need to be
adjusted and fine tuned for each individual patient. This
can only be done once the devices have been surgically
implanted. To provide the best possible level of care,
doctors use specially designed mobile computers, like the
orchestra+ programmer for medical pacemakers from the
Sorin Group, to adjust the settings of the implanted device.
A special electrocardiogram sensor placed on the patient’s
chest and connected to the orchestra+ programmer enables
doctors to obtain parameter information from the pacemaker
and adjust the settings without the need for invasive
surgery. The portable programmers are also used for regular
patient check ups and responding to emergencies.

The challenge: Meeting international standards

One of the biggest challenges in developing medical
equipment is meeting the strict international safety
standards such as the EN 60601-1 (Europe) and UL 60601-1
(USA) that define the requirements concerning mechanical
stability as well as electromagnetic compatibility (EMC)
to ensure interference-free operation with other devices.
Performance is also important. In urgent cases, the medical
programmer needs to boot quickly and rapidly display
graphically the information from the pacemaker.

The solution: A single source

Companies like the Sorin Group that develop highly specialised
medical technology for use in cardiac surgery
rely upon expert partners to design and develop medical
computers. For the new orchestra+ programmer, the Sorin
Group outsourced the entire development and production
to Kontron who supplied not only the embedded computer
technology consisting of a proven and highly reliable
ETX® Computer-on-Module and custom designed carrier
board, but the complete finished product including tested
implementations of TFT touch screen, keyboard, hard disk,
power supply and fan as well as the easy to handle lightweight
plastic casing. Outsourcing the entire design and
production to a single partner that can supply the complete
value chain is the most cost-effective solution: On the one
hand, the Sorin Group frees up the maximum amount of its
own resources since there is no need to manage multiple
suppliers, enabling the company to concentrate on its core
competence of developing innovative technology for cardiac
surgery. Additionally, working closely with a single partner
who has experience in product life-cycle management for
medical equipment designed in accordance with the relevant
EN and UL standards reduces application development and
evaluation resulting in quicker time-to-market.

Meeting international safety requirements

To minimise weight for easy handling, Kontron designed the
portable orchestra+ with a tough plastic casing. To meet the
EN 60601-1 and UL 60601-1 standards for human life related
systems, the electronics and casing have been designed to
ensure that the orchestra+ does not expose any live parts
or cause a fire, electric shock, or mechanical hazard even
in the event that it is dropped. The international standards
also place strict requirements on product life management
and traceability as well as other safety features such as
leakage current limits and adequate shielding to ensure
electromagnetic compatibility (EMC) with other devices. In
order to meet the EMC requirements, Kontron used galvanic
separation to electronically isolate boards and interconnects
and applied an ultra-thin metal coating to the inside of the
plastic casing as well as a difficult-to-apply 10ųm primer.
Control procedures are rigorous. Before delivery to the Sorin
Group, each batch of orchestra+ programmers is controlled
by an external test laboratory. This “proof of concept”
procedure ensures that each orchestra+ meets the EU and US
standards for electronic medical devices.

Optimal mix of standard and customised electronics

For the embedded computing technology, Kontron’s
dedicated medical technology team went for a design
based on the Kontron ETX-PM Computer-on-Module with
a customized carrier board. An ETX® Computer-on-Module
was chosen because the ETX® specification is a de-facto
industry standard (created by Kontron and adopted by
many others) that defines a well-proven PCI and ISA-based
module form factor for highly reliable and cost-effective
processing performance for applications that do not require
PCI Express. Based on the low power 1.6GHz Intel® Pentium
M processor that has a TDP of just 24.5 watts and 512
MB of energy efficient DDR SDRAM, the Kontron ETX-PM
Computer-on-Module provides exactly the right performanceper-
watt values. Moreover, the fast boot time enables
doctors to provide treatment as fast as possible. Kontron’s
Boards and More carrier board design services delivered the
custom carrier board with a special serial interface for the
electrocardiogram sensor, as well as an interface for the TFT
monitor, an IDE port for the internal hard drive and USB
2.0 and floppy interfaces. Using a design built around a
customised carrier board paired with a standard Computeron-
Module reduces development costs since there is no
need for a fully customised solution. Since the Kontron
ETX-PM follows the ETX® standard, it is fully interchangeable
with other ETX® compatible Computer-on-Modules for easy
upgrades and maximum future security.

Project management made easy

The Kontron medical team also selected the TFT touchscreen,
keyboard, hard disk, power supply and fan and carried out
the entire development and validation as well as the required
pretesting. After gaining the required certification, serial
production is now underway at Kontron’s own FDA (US Food
and Drug Administration) registered manufacturing facilities.
At this stage of the project, Sorin Group only has to tell
Kontron how many units they need. Kontron takes care of
everything else, including all that is needed for managing
long-term availability of the orchestra+. For example,
should a component be discontinued, Kontron intervenes
immediately and resolves all necessary steps with the Sorin
Group to ensure continuous product availability. Moreover, the
availability of components used in the current configuration
is guaranteed for at least five years. This is important because
significant changes would require renewed certification to
ensure continued adherence with the relevant standards. This
would add extra costs. Should a component be discontinued
within this time frame, Kontron issues a continuation of
supply order that guarantees the continued availability of the
component. If necessary, Kontron also selects and certifies
alternative components.

“Working with Kontron makes project management
easy,” declared Dominique Grégoire, of the Sorin
Group. “Kontron knows exactly which international
requirements need to be met for medical equipment.
We understood each other right from the beginning and
were able to get started on the project straight away,
enabling fast development of the first prototype for
validation. All of our communication with Kontron is
dealt with professionally and efficiently, enabling us to
free up our own resources and concentrate on our core


The Sorin Group has found a supplier for its medical
computer systems that is able to assume responsibility
for the whole project – from selecting the right
components including the Computer-on-Modules and
customised carrier board to delivering the finished system
with the required certifications. The system itself is an
easy-to-handle and extremely reliable medical computer
that not only meets international requirements for
electronic medical equipment, but also offers maximum
future security and lower total costs of ownership.

Kontron project management services

Kontron’s comprehensive customisation, engineering
and project management services are especially
designed to enable OEMs, system integrators and
designers achieve faster time to market for their
applications in the medical, industrial automation,
energy, telecommunication, defense/aerospace,
transportation, POS/POI and infotainment markets.
Kontron’s dedicated global business units work closely
with customers to design and manufacture tailor-made,
application-ready OEM platforms ranging from industrial
servers and medical PCs to pre-integrated and fully
tested ATCA and MicroTCA platforms as well as rugged
Modular Embedded Computers (MEC) amongst others.

In developing a customised solution, Kontron draws
upon its comprehensive portfolio of standard, off-the-shelf
products that includes Computer-on-Modules,
boards and mezzanines, HMIs and Panel PCs as well as
systems and platforms. Using standard, off-the-shelf
components and platforms minimises development
costs and accelerates time-to-market. Production takes
place at Kontron’s advanced testing and manufacturing
facilities that are ISO 9001 and ATEX-certified to ensure
consistency and the highest level of quality in products
and services on a global basis. Each Kontron business
unit has specialist expertise in its respective vertical
market to ensure that all OEM platforms are designed and
produced in accordance with the highest international
certifications and standards. Kontron also organises
and coordinates rigorous product testing of prototype
and series products at independent testing laboratories.

Long-term availability management and EOL management
round off the project management services that cover the
entire value-added chain, enabling customers to free up
the maximum amount of internal resources in order to
concentrate on their core competences, reduce total cost
of ownership and ensure fastest time to market of their