Intended Use Of The Device; Usage Environment; Operating Limits - Klaxon TWIST Gebrauchsanleitung

At high speed the user may lose control of the wheelchair and it may tip over. Never drive faster than 15
km/h (6 Km/h in Controller mode), both uphill and downhill, and avoid impacts in general.
Always use the TWIST-equipped wheelchair appropriately. Always brake in order to avoid obstacles (steps,
edges, door frames, etc.), during descents, turns, and/or dangerous inclines.
Driving performance of the TWIST-equipped wheelchair may be affected by electromagnetic fields. If a
malfunction occurs in these conditions please contact KLAXON or one of its authorised resellers.
Avoid contact with liquids leaking from the battery in case the battery is damaged.
While using the device, some system components can get very hot (e.g.: braking system, etc.). A contact
of these components with the skin may cause scalding and burns: be extremely careful to avoid contact.
Always observe the operating limits for the manual wheelchair on which the TWIST device is installed.

3. INTENDED USE OF THE DEVICE

The TWIST device can be used to add an auxiliary power assist system to most of the manual wheelchairs,
quickly and easily.
By installing the TWIST device at the front of the wheelchair (front configuration with or without handlebar), the
front castors are lifted off. The single wheel of the "traction unit" is then used for steering.
The system consisting of the TWIST device installed to the manual wheelchair falls within Class B according to
EN 12184:2014. TWIST devices meet the requirements of Class B. In accordance with the definition of Class
B in EN 12184:2014, the device is intended for use in an indoor environment and is capable of dealing with
outdoor obstacles.
Any other use or misuse could lead to hazardous situations.

4. USAGE ENVIRONMENT

Operating Environment
The TWIST device is manufactured in order to be installed to the majority of wheelchairs on the market. TWIST
can be used both indoors and outdoors, within the limits stated in this document and, in general, according to
the same limitations of use as those of the manual wheelchair (as established by its manufacturer). In case of
doubt please verify all the limitations by reading the End User Muanuals or by contacting the manufacturers
concerned.
Medical use and types of users
The TWIST device is not intended for a specific clinical use, but as a mobility support for people using manual
wheelchairs. Therefore, no professional, technical, or attitudinal requirements are necessary to use or operate
the TWIST device, other than to follow the instructions described in this document. Limitations for specific
categories of users are described in this End User Manual.
The TWIST device is defined under EU 745/2017-MDR as a "Class I Medical Device".

5. OPERATING LIMITS

The device must be used consistently with the intended use described in the preceding chapters, any other use
is considered as improper.
In particular do not use TWIST:
If not installed to a manual wheelchair.
After intake of alcohol or if the user's psycho-physical conditions are unsuitable
On roads with unsuitable pavement.
In poor visibility conditions (fog, etc.).
If the user weighs over 120 kg or is heavier than allowed for the wheelchair used.
In adverse weather (rain, strong wind, etc.).
When going uphill or downhill on slopes that are exceeding 6°/ 10%.
In overcoming, either in going up or down, steps higher than 30 mm in height.
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KLAXON Mobility GmbH - EN
KLAXON TWIST device - End User's Manual (EN) - rev. 1.5 of 2023.02.08