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application, indication, contra-indication
file: n:\article\cos14310m5-v1_06hpc-en\20120215_cos14310m5-v1.06hpc-en_manual_h-p-cosmos_running_machine.doc
© 2012 h/p/cosmos sports & medical gmbh [email protected] created 15.02.2012 printed 15.02.2012 page: 40 of 213
[5.C]
Risk and benefit of treadmill application
The use of treadmills is supported by medical doctors all around the world for more than 50 years now. Since all
available specialists literature points out the benefit of treadmill application explicitly, and the risks are well controllable,
the benefit exeeds the risks. The manufacturer releases the medical product for the described applications and
indications.
Clinical studies are obsolete and have not been ordered by h/p/cosmos by now, since there is a huge amount of
literature, over 50 years of experience in application worldwide and the performance data according to EN 957-6.
The medical treadmills may be operated only in medical facilities by medical personnel. The safety requirements for
medical electrical equipment - in particular requirements for medical electrical equipment and medical electrical systems
for the medical care in a home environment (IEC 60601-1-11) - are not considered in the medical device, h/p/cosmos
treadmill ergometer.
An application of the h/p/cosmos medical products treadmills in a home environment and / or in the
open and / or by not medically trained personnel is not allowed.
Overload of the patient by wrong application and/or by misinterpretation and/or by unexpected problems during correct
application may result in the following risks, problems and/or injuries:
Problem & injury risk
Risik control
Injuries of the muscoskeletal system (joints, tendons,
ligaments, muscles, bones) due to overloading and/or
fall over and skin abrasions, bruises, sprains and torn
ligaments, fractures and broken neck in worst case
resulting in death.
1.
Note in instructions and warning labels on the user
terminal, that the use of the device may only occur
under supervision by medical or therapeutic staff.
2.
Proper loading dose must be prescribed by doctors
or therapists as qualified personnel only.
3.
Notes in instructions and warning labels on the user
terminal that operating personnel must stay in
permanent patient environment of 1.5 m.
4.
Recommendation and application of weight support
system and / or fall stop device, such as the
h/p/cosmos safety arch with harness and and
automatic shut-off of the running belt.
5.
Comprehensive instruction of the patient before the
start of treadmill therapy with an explanation that the
drive of the running belt is very strong and does not
stop automatically, if the patient remains standing.
Overload of the cardiovascular system in extreme
situations with cardiac arrest and death.
1.
Note in user’s manual for correct load dosing by a
medical doctor or therapist.
2.
Note to keep a defibrillator ready for reanimation.
Country-specific this is already standard.
3.
Integrated cardio mode, which reduces the load after
reaching the recommended maximum heart rate and
stops the treadmill in case overload or breakdown of
the heart rate measurement.