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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 Guide before use and save it for future reference.
Intended purpose
The device is a standing frame for children
and adults with disabilities.
Indications
The device can be used by children and adults
with disabilities, who experience limitations
in their ability to maintain a standing position.
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 standing in the frame.
The caregiver is the person operating the
frame. Never leave the user unattended in
this product. 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 or sitting in another
assistive device or a conventional product.
Contra indications
There are no known contra indications.
Precautions
Special attention should be given to the
considerations about the configuration of the
product and the use of accessories for users
with limitation in their:
• Sensory functions and the sensation
of pain, consider extra checks of the
pressure caused by the support provided
by the product and its accessories.
• Movement function (e.g. experience
involuntary movements).
• Ability to maintain a standing position, use
the product with accessories (e.g. chest or
back support).
• Ability to maintain the position of their
head, consider to use accessories or to
use a product that provide support to the
positioning of the head.
Application areas
The product is for indoor use
Enclosed tools:
• 5 mm Allen key
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:
• EN 12182
The CE mark must be removed when:
EN
ENGLISH
• Rebuilding the product
• Using the product outside the intended
purpose and declaration of conformity
• Using other than original R82 spare parts
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:
• 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
old batteries as much as possible, i.e., by
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