Etac R82 Combi Frame:x, User Manual

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etac.com
ENGLISH
We appreciate your choice of a new product from R82 - a worldwide supplier of technical aids and appliances for children
and adults 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 frame for seating systems 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 seat used with 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, standing or sitting in
another assistive device or a conventional product.
For transportation the device is suitable for children and
adults in the weight range of 22 kg to specified max user
weight for transportation.
Contra indications
There are no known contra indications
Precautions
There are no known precautions
Application areas
The product is for indoor and outdoor use
Enclosed tools:
• 3, 4, 5 and 6 mm Allen key
Declaration of Conformity
This product conforms to the requirements of the
Medical Devices Regulation (2017/745). The CE mark
must be removed when rebuilding the product, when
used in combination with a product from another
manufacturer or when using other than original R82
spare parts and fittings. Further, this product conforms
to the requirements according to:
•
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 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.
Accessories and spare parts
The products from R82 can be supplied with a variety
of accessories including vests and belts which comply
with the needs of the individual user. Spare parts can
be ordered on request. Find the specific accessories
on our website or contact your local dealer for further
information.
R82 Warranty
R82 offers a 2-year warranty against defects in
workmanship and materials and a 5-year warranty
on breakage of the metal frame caused by defects
in welds. The warranty would be adversely affected
if the customer’s responsibility of servicing and/
or maintenance is not carried out according to the
guidelines and intervals prescribed by the supplier and/
or stated in the User Guide. For further information, we
refer to the etac homepage/download.
The lifetime of this product in normal use is 8 years if all
maintenance and servicing is carried out in accordance
with the manufacturer’s instructions and demonstrably
recorded. The device may be reissued within its lifetime
The warranty is only granted in the country where
the product was purchased and if the product can be
identified by the serial number. The warranty does not
cover accidental damage, including damage caused
by misuse or neglect. The warranty does not extend to
consumable items e.g. tires or upholstery, which are
subject to normal wear and tear and need periodic
replacement.
The warranty is null and void if other than original
parts/accessories are used, or if the product has not
been maintained, repaired or altered according to the
guidelines and intervals prescribed by the supplier and/
or stated in the User Guide. R82 reserves the right to
inspect the product being claimed for and the relevant
documentation before agreeing to the warranty claim,
and to decide upon whether to replace or repair the
defective product. It is the customer’s responsibility to
return the item being claimed for under warranty to the
address of purchase.
Presales information
• www.etac.com
EN