Back training device with high precision sensors

Innovation
for success
Success in medical technology
Back training device with high-precision sensors
Hocoma AG, Switzerland
“Hocoma has set itself the goal of
developing and manufacturing highquality products. For our products,
quality means: Benefits for patients
and therapists, safety and user-friendliness. Cicor is a partner with a broadbased technical expertise in medical
technology and accompanies us
professionally across the entire
development and production process,
through to after-sales service.”
Hocoma AG, Switzerland
Functional medical technology
with high motivational factor
Cicor develops and produces the Valedo therapeutic back training device
for the Swiss company Hocoma.
Hocoma is a global market leader in the development, manufacture and marketing of
robotic and sensor-based devices for functional movement therapy. The innovative
solutions come into use in the rehabilitation of patients with neurological movement
disorders and in therapy for back pain both in the clinic and at home.
Electronic Solutions
The latest technology standards for
therapeutic exercises with playful flair
The Valedo mobile back training device
transmits and records the movements
of the trunk using two Bluetooth sensors
and thus allows the patient and therapist
real time feedback and immediate training evaluation. The clinical exercises
are didactically structured and have
been specially developed for movement
therapy of the lower back. The softwarecontrolled exercises support and encourage stepwise learning of complex and
multi-dimensional movements.
Valedo was especially developed for
long-term promotion of back health and
helps prevent back pain. Therapeutic exercises developed for functional movement
therapy of the lower back, in combination
with motivating and entertaining games,
train the back muscles, mobilize the spine
and contribute to improved movement
awareness.
The sensors of the registered medical
device include the latest Bluetooth Smart
Technology (low energy) and therefore
set new technology standards. Each
sensor contains a 3D gyroscope, a 3D
accelerometer and a 3D magnetometer
and so can record full 360 degree movements. The innovative, high precision
sensor technology and the motivating
power of video games strengthen the
back in a playful way.
“As an outsourcing partner, we support our customers in the development of the product,
in mechanical design, in making an optimum choice of material, through to production and
selection of the right packaging and supply chain management.”
Cicor
Electronic Solutions
Innovative outsourcing partner
for revolutionary products
Cicor supports the customer from the
idea through to the realized product.
We see ourselves as the partner across
the entire supply chain. The demands
placed on an outsourcing partner in the
manufacture of electronic medical devices
and systems are extremely high. Trust
is an important prerequisite for successful cooperation. As we hold the relevant
ISO certifications, we ensure compliance
with all quality standards. The development process and production are ISO 9001
and ISO 13485 certified, the hardware
concepts are designed according to the
93/42/EEC directive.
The mechanical design of the Valedo
product was the key focus of our
collaboration. Cicor was responsible
for the complete development of the
mechanical layout. Here the special
challenges were International Protection
(IP protection), biocompatibility, as well
as product safety (drop test) according
to IEC 60601.
The use of the latest technology, in this
case Bluetooth Smart Technology and
the 3D functions (3-axis gyro sensors),
led to the development of customerspecific test concepts.
Product development
Layout
Mechanical design
Test development
Redesign
Cicor has developed efficient test concepts for parallel testing of the product
functions. For instance, each interface of
the Bluetooth sensor is tested through
the active movement.
As an outsourcing partner, Cicor supports
Hocoma across the entire supply chain.
Cicor undertakes final assembly, labeling
and packaging, as well as shipping to
the customer-specific sites. Hocoma can
therefore fully concentrate on its core
competences.
Test concepts
Validation
NPI
Logistic model
Procurement
cle managemen
Life cy
t
Development
strialization
Indu
A ft er-s ale s
Warranty
Repair services
Maintenance
Modification
Obsolescence Management
P ro d u c ti o n
Q u a lit
y m anage m e nt
Prototyping
Board assembly
System assembly
Plastic injection molding
Toolmaking
Electronic Solutions
Specific expertise and longstanding
experience in medical technology
Services and products in the field of
medical technology demand a high
degree of reliability and trust. Thanks to
its technical expertise and longstanding
experience in medical technology,
Cicor offers innovative solutions that
meet all requirements for sophisticated
development and production of medical
devices.
Certification of development and
production to ISO 13485 ensures the
customer‘s requirements and the
applicable regulatory requirements
are taken into consideration.
Longstanding experience in the
development and production of
medical devices.
The hardware and software concepts
are aligned with IEC 60601 (Medical
electrical equipment – General requirements for basic safety and essential
performance).
Quality data management
ensures safety and
traceability
The traceability of components and
system configurations is pivotal in being
able to guarantee that quality requirements, such as functional safety and
system stability, can be met. This key
factor must be ascertained on the basis
of legal requirements and the customer‘s
specifications. Quality data management
systems provide complete transparency
in all manufacturing and after-sales
processes. Cicor‘s verified quality data
management system extends far beyond
the legal requirements. It encompasses
numerous functions that we configure
according to the customer’s specific
needs.
Electronic Solutions
Developing innovative
solutions
The challenge
Expertise in medical device manufacturing
(Risk class 1 according to 93/42/EWG and ISO 13485)
Documented Traceability thanks to quality data
management
Global component purchasing power
Compliancy in the latest technology standards
(e.g. Bluetooth Low Energy)
Reliable and certified manufacturing processes
Logistics & manufacturing in multiple locations
The requirements
Developer expertise
In-depth knowledge of standards
Mechanical design
ISO 13485 certification and longstandingexperience
In-house production
Prototype and series production
Test engineering
Industrialization
Logistics
Local partner with a global reach
The Cicor solution
Superior technology solutions for medical technology
EMC (electromagnetic compatibility)
Low-energy rechargeable battery
State-of-the-art hardware design
9-axis sensors
Biocompatibility
Drop and impact test according to IEC 60601
Firmware/Software upload
Ports
Micro-USB
Bluetooth 4.0 LE
Test concept for 3D sensors
Logistics concept
Management
Packaging
Benefits
for Hocoma
Dependable partner throughout the entire
product lifecycle
Reliable and certified manufacturing processes
Complete traceability thanks to QDM
for the therapist
Higher patient compliancy
Relevant exercises extend therapy
Tool to analyze patient progress and performance
Registered and certified medical product
for the patient
Independence with a product to enable
self-guided therapy
Motivating therapeutic exercises for back health
Immediate performance evaluation and reporting
Promotion of movement awareness and specific
therapy goals
Safe, reliable, portable technology
Contacts Cicor
Europe
Advanced Microelectronics & Substrates
Cicorel SA
Route de l’Europe 8
2017 Boudry I Switzerland
Tel. +41 32 843 05 00
Fax +41 32 843 05 99
[email protected]
America
Cicor Americas Inc.
185 Alewife Brook Parkway, Suite #410
Cambridge MA 02138 | USA
Tel. +1 617 576 2005
Fax +1 617 576 2001
[email protected]
Asia
Cicor Asia Pte Ltd.
45 Changi South Avenue 2
#04-01 Singapore 486133
Singapore
Tel. +65 6546 16 60
Fax +65 6546 65 76
[email protected]
Head office
Cicor Management AG
Leutschenbachstrasse 95
8050 Zurich I Switzerland
Tel.+41 43 811 44 05
Fax +41 43 811 44 09
[email protected]
cicor.com