intended use, contraindications, risks
&
forbidden use
file: n:\article\cos14310m5-v1_07hpc-en\20130207_cos14310m5-v1.07hpc-en_h-p-cosmos_treadmill_manual.doc
© 2013 h/p/cosmos sports & medical gmbh author: fh [email protected] created 07.02.2013 printed 04.03.2013 page: 17 of 197
General Remaining risks
Overload of the patient due to wrong application and/or misinterpretation and/or unexpected problems during correct
application may result in the following risks, problems and/or injuries:
Problem & injury risk
Risk control
Due to overloading and/or fall :
N
Bruises
N
Sprains and torns
N
Skin abrasions
N
Injuries of the musculoskeletal system
(joints, tendons, ligaments, muscles,
bones)
N
Fractures, in worst case (e.g. broken neck)
resulting in death.
N
Note in instructions and warning labels on the
UserTerminal that the device may only be used
under supervision by medical or therapeutic staff.
N
Proper loading dose must be prescribed by doctors
or therapists as qualified personnel only.
N
Note in instructions and warning labels on the
UserTerminal that operating personnel must stay in
permanent patient environment of 1.5 m.
N
Recommendation and application of weight support
system and/or fall stop device, such as the
h/p/cosmos safety arch with harness and automatic
shut-off of the running belt.
N
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 when the patient stops.
Overload of the cardiovascular system in extreme
situations with cardiac arrest and death as possible
worst case scenario.
N
Note in user’s manual that correct load dosing must
be done by a medical doctor or therapist.
N
Note that a defibrillator has to be kept on hand for
reanimation. This is already standard in some
countries.
N
Integrated cardio mode, which reduces the load
after reaching the recommended maximum heart
rate and stops the treadmill in case of overload or
breakdown of the heart rate measurement.
In case of correct load dosing (according to the clinical picture and condition of the patient) and intended use, the risks
are comparable to the risks of walking / running on the ground: falling off the treadmill with skin abrasions, bruises, torn
ligaments, fractures and in worst case fatal injury such as a broken neck.