safety, warnings, precautions, prohibitions
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© 2012 h/p/cosmos sports & medical gmbh [email protected] created 15.02.2012 printed 15.02.2012 page: 36 of 213
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h/p/cosmos trains all relevant service technicians and sales personnel as medical device consultants with
respective certification.
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The user manuals of h/p/cosmos treadmills contain all important information and safety advice as well as
maintenance instructions and user regulations. The treadmills have a label with the date of the next safety
check / maintenance.
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h/p/cosmos offers numerous options and accessories such a safety arch with harness for fall prevention,
chest belt with automatic stop, arm supports or the unweighting system h/p/cosmos airwalk, which increase
safety for the patient during the use of a treadmill-ergometer. http://www.h-p-cosmos.com/en/safety/index.htm
All running machines and other machines with moving belts and parts, hold a great potential of danger at the belt
re-entry zones on the sides and at the end of the running surface, as the gap between running belt and frame is
frequently too wide. To reduce the risk for users, h/p/cosmos running machines have a gap of less than 4 mm and
it is marked clearly with additional danger precaution stickers.
Therefore we take it as our responsibility to inform our partners and customers about the background and
necessity only to use medical products in the medical application field. Statutory requirements only permit us to
supply medically classified equipment for medical applications.
Medical Device Directive Article 1 Definitions, scope 2 a.)
“medical device” means any instrument, apparatus, appliance, material or other article, whether used alone or in
combination, including the software necessary for its proper application intended by the manufacturer to be used
for human beings for the purpose of: Diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for any injury or handicap, investigation,
replacement or modification of the anatomy or of a physiological process, control of conception, and which does
not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic
means, but which may be assisted in its function by such means;
The use of a product not released for medical use by the manufacturer in a medical application can result in
increased risks for the patients and for the operator – especially in the case of an accident on the treadmill
ergometer. In this case all parties involved (your insurance company, your professional association, possibly
patients lawyers and courts) will question negligence and liability. Therefore the use of a sports device for medical
purposes bears increased risks for the distributor, customer, operator, end user and last but not least the patient.
Despite that some of the above mentioned laws and guidelines are only binding within the European Union, the
patient’s needs, the risks and the required safety procedures are the same all over the world. We ask all parties
involved to help in improving safety.