Unauthorized Access; Residual Risk / Side Effects (Med); Firefighting; All-Pole Disconnection - h/p/cosmos 170-190/65 Series Original Instructions Manual

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 (med)

After risk reduction most risks are "acceptable". Only a few risks remain "widely acceptable".
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.
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 of medical devices, an electric shock, which can
result in death, can never be ruled out completely.
The residual risk of strangulation and trapping of clthes / 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 medical 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 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 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 30 years of history and with more than 10,000 h/p/cosmos treadmills on the worldwide market, there has never been such a
reported incident.

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 from voltage power supply:
Unplug device from power socket.
❚
Unplug cable from device (if possible).
❚
Switch off device protection switch
❚
Maintain enough free space to ensure access to cables and the circuit breaker (see "position of subject and operator").
© 1988 - 2019 h/p/cosmos sports & medical gmbh cos105000_170-190_65, rev. 1.03 page 25 of 99