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4.6 Unauthorized access
See OP 40 … 44 in the User Options to lock the whole device or individual modes.
4.7 Residual risk / Side effects
After risk reduction only 13 of more than 230 causes are in the "widely acceptable" region.
In case fall prevention 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.
Furthermore there is residual risk such as unintended overload of the patient 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 patient.
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 of medical devices, an electric shock, which can
result in death, can never be ruled out completely.
The residual risk of strangulation can not be excluded as well. The risk is 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 medical product might show further risks.
In 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 benefit of treadmill training in contrast to these
alternatives is clearly outweighing the residual risk 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 patient, the user, the operator or third persons.
4.8 Firefighting
Do not use liquid firefighting resources.
Use CO2.
4.9 All-pole disconnection
The following options are available for all-pole disconnection:
❚
Unplug device from power socket.
❚
Unplug cable from device.
❚
Switch off device protection switch
Maintain enough free space to ensure access to cables and the circuit breaker (see “position of patient and operator”).
