7.5
Unauthorized access
See Options 200 - 204 to lock the whole device or individual modes.
7.6
Residual risk / Side effects
After risk reduction most identified risks are "acceptable". Only a few risks remain "widely acceptable".
In case fall prevention device (safety arch with harness and chest belt or airwalk unweighting device) is not applied or not applied
correctly, there are residual risks, such as falling of a person resulting in skin abrasions, bruises, fractures or in worst case even
death.
These risks may occur during use as well as when entering or leaving the device and during stand-still in elevation.
Furthermore there is residual risk such as unintended overload of the subject caused by wrong operation, wrong assessment, or
wrong application of the operator and also incorrect data transfer (e.g. electromagnetic interferences, software failure, etc.). Even
the best software and hardware safety concepts can never completely rule out a failure of software or hardware and thereby a
theoretically possible overloading of the subject.
Since the treadmill is an electrically operated device, an electric shock, which might result in death can never be ruled out. Although
the design and verification is according to the relevant standards for electrical safety, an electric shock, which can result in death,
can never be ruled out completely.
Due to their advanced technology the PC and the touch panel have an expected lifetime of 5 years. The thoroughly carried out risk
management evaluates the risk emerging from a PC breakdown as acceptable.
The residual risk of strangulation and trapping of clothes / shoes / fingers / hair or other (body) parts in the elevation system, belt re-
entry zones or other moving parts can not be excluded as well. These risks are reduced by safety information within the IFU.
It cannot be excluded that unintended or forbidden use might cause further not yet regarded risks and that already regarded risks
might have been estimated incorrectly. It can also not be excluded that the daily use of the product might show further risks.
For medical applications such as ergometry, diagnostics and therapy there are alternatives to treadmill application such as
bicycle ergometry (without natural gait movement) or overground gait therapy (secured only by the therapist), etc.. The benefits
of treadmill training in contrast to these alternatives are clearly outweighing the residual risks of falling or overload with the known
consequences.
In this risk analysis the "present state" of the device has been evaluated.
Having carried out the evaluation and validation of the product, the risk of appearance of a not acceptable risk is very low.
The device (it´s construction, it´s function as well as the intended application) does - under normal conditions - not represent any
unjustifiable risk for the subject, the user, the operator or third persons.
However, the risk of injury or even death due to a malfunction of the treadmill is very low.
In over 33 years of history and with more than 10,000 h/p/cosmos treadmills on the worldwide market, there has never been a
reported incident.
Thus, the h/p/cosmos products covered under this risk management file are considered to be very safe, in compliance with
applicable standards and regulatory requirements and can be released for serial production to be placed on the market.
❚
MCU6
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 24 of 97
