[3.H3] H/P/Cosmos Medical Running Machines - Mdd Medical Device Directive. Safety Standards - h/p/cosmos 150/50 locomotion de med Operating Instructions And Service Manual

h/p/cosmos medical running machines - MDD medical device directive. Safety standards
[3.H3]
Over 20 years of experience in the production of treadmill-ergometers and complex systems with accessories and
special options have made h/p/cosmos the absolute treadmill specialist. We consider ourselves as the "market
precursor in technology and safety" amongst all treadmill manufacturers. Safety has a very high priority for us –
above all because we know from experience what kind of accidents can occur and which consequences might
result from these accidents.
On the one hand a treadmill is a very effective instrument in rehabilitation, therapy and diagnostics. However, like
in many areas of daily life (i.e. all kinds of traffic, may it be by car, train or bus or the handling of electrical machine
tools etc.) the use of a treadmill involves dangers which can be minimized by abiding strictly to safety procedures,
but can never be fully ruled out. As a manufacturer it is h/p/cosmos' duty, and as the distributor or end-
user/operator of the running machine it is your duty, to minimize those dangers as far as possible.
In medical applications many additional risks (patients with pacemakers, ECG lead and electrode connections to
the skin, health and physical limitations, high workloads during stress tests, medication, etc.) have to be
considered. Therefore medical treadmills with interface and interactive heart rate based load controls are classified
as risk class IIb medical devices. They have specific additional design characteristics compared to fitness
treadmills, and can only be sold and serviced by authorized and certified distributors. h/p/cosmos has the
responsibility to ensure that the systems are correctly installed (with usage instruction) and maintained. Therefore
we have implemented a medical device observation and reporting system based on the statutory obligations
contained in, Guideline 93/42 EEC, MDD (medical device directive), ISO9001 and EN13485 standard and our
internal safety policy and risk management system. This is of utmost importance and all our distributors must sign
a contract that they will comply with these important international rules for medical devices, particularly for class IIb
devices and their respective statutory requirements.
h/p/cosmos fulfils its duty in different ways:
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All medical treadmill-ergometer device-families have to undergo an internal product-type examination as well
as external tests performed by the respective examination institutes such as the TUV Product Service in
Munich / Germany or the EMC laboratory. Our medical treadmill-ergometers meet the norms and guidelines
stipulated for medical applications such as the, MDD, EU guideline 93/42 EEC for medical products, IEC EN
60601-1 (VDE 0750), VDE 0751, IEC EN 60601-1-2 (EMC), IEC EN 60601-1-4, EN 957-1, EN 957-6.
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All h/p/cosmos medical treadmill-ergometers must undergo a 24-hour non-stop test after production with strict
safety tests, high-voltage-tests and electrical as well as mechanical safetychecks. All tests are recorded,
checked by a second independent employee and filed. h/p/cosmos treadmills have to pass the checks 100%
without exception.
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All medical h/p/cosmos treadmill-ergometers have an Emergency Off Switch (current off with mains
disconnection, not only the "standard software controlled emergency stop button"), power supply with
increased voltage resistance, electrical installation and wiring according to IEC 60601-1, a potential
equalization pin and a potential equalization transformer.
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h/p/cosmos has a quality management and risk management system according to ISO 9001:2000 & ISO
13485:2003 as well as medical device observation and incident reporting system.
© 2008 h/p/cosmos sports & medical gmbh
file: n:\article\cos14310m5-v1.04hpc-en\20080901_cos14310m5-v1.04hpc-en_manual_h-p-cosmos_running_machine.doc
email@h-p-cosmos.com
safety, warnings, precautions, prohibitions
created 01.09.2008 printed 08.10.2008 page: 18 of 176