Intended Purpose; Declaration Of Conformity - Etac R82 Bedienungsanleitung

General
We appreciate your choice of a new product from R82 - a worldwide supplier of technical aids and ap-
pliances for children and teenagers with special needs. To fully benefit from the options offered by this
product please read this user manual before use and save it for future reference.

Intended purpose

The High-low:xo is a frame for a seating system
for children and adults with disabilities.
Indications
The device is used together with a seating
system (i.e. a modular seating system like R82
x:panda or R82 Panda Futura). It can be used
by children and adults with disabilities, who
lack the ability to maintain a seated position
and move around (Within the room or between
rooms / outdoors) without an assistive device.
The target group for the device is based on
functional ability and anthropometry. It is not
based on a specific health condition or age.
The user is the person sitting in the device.
The caregiver is the person operating the
device. Never leave the user unattended in
this device. Ensure permanent supervision by
a caregiver.
The use of the device will be discontinued
more times during the day where the user will
be lying down, standing or sitting in another
assistive device or a conventional product.
The outdoor version of the device is approved
for transportation for children and adults in
the weight range of 22 kg to specified max
user weight for transportation.
Application areas
The product is for indoor and outdoor use
Contra indications
None
Precautions
None
Enclosed tools
None

Declaration of Conformity

This product conforms to the requirements of
the Medical Devices Regulation (2017/745).
Further, this product conforms to the
requirements according to:
• High-low:xo indoor: EN 12182
• High-low:xo outdoor: EN 12182 & EN
12183
The CE mark must be removed when:
• Rebuilding the product
• Using the product outside the intended
purpose and declaration of conformity
• Using other than original R82 spare parts
EN
ENGLISH
and fittings
When combining the device with other
products, the combination must not change
the intended purpose of the products or
modify the products in such a way that
compliance with the applicable requirements
may be affected. The person / company
responsible for the combination of the
products must ensure that the applicable
requirements are fulfilled.
Applicable requirements examples:
• Alignment of user weight/mass of the
combined seat and base, approval for
transportation in vehicles of both products
(ISO16840-4 for seat and ISO7176-19 for
base)
• Material safety (biocompatibility,
flammability), mechanical safety (stability,
squeezing hazards, inter connection),
electrical safety
Disposal
When a product reaches the end of its lifetime,
it should be separated by material type so
that the parts can be recycled or disposed
of properly. If required, please contact your
local dealer for a precise description of each
material. Please contact your local authorities
to be informed of the options available for
recycling in an environmentally-friendly way.
The symbol of the crossed-out trash can on
batteries or accumulators states that they
must not be disposed of in household waste
at the end of their service life. If batteries or
accumulators contain mercury (Hg), cadmium
(Cd) or lead (Pb), you will find the respective
chemical symbol below the symbol of the
crossed-out trash can. You are legally obliged
to return old batteries and accumulators
after use. You can do this free of charge at
the retail store or at another collection point
in your area. Addresses of suitable collection
points can be obtained from your city or local
government.
Batteries can contain substances that are
harmful to the environment and human
health. Special care should be taken due
to the special risks involved in handling
lithium-containing batteries. The separate
collection and recycling of old batteries and
accumulators is intended to avoid negative
effects on the environment and human health.
Please avoid the generation of waste from
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