Intended Environment; Intended Application; English (Original Instructions) - Etac R82 Addax Bedienungsanleitung

General
We appreciate your choice of a new device from R82 - a worldwide supplier of technical aids and applianc-
es for children and teenagers with special needs. To fully benefit from the options offered by this device
please read this user manual before use and save it for future reference.
Intended purpose
The family of R82 Standing devices consist of
assistive devices intended for the alleviation of or
compensation for a functional impairment due to
an injury or disability. The devices are designed
for an individual lacking the ability to maintain the
standing position without the use of an assistive
device.
Addax is an assistive device designed to support
infants, children and adolescents (and adults who
fit within the dimensions of the device) to perform
supported standing. The device is intended for
users where limited leg and trunk control makes
standing upright without support difficult or
impossible. The device has adjustable features in
the frame and accessories to accommodate for
the individual needs of the user.
Intended user group
Selection of an appropriate device size is
dependent on body weight and physical
dimensions of the user. Secondary users of the
device are caregivers providing assistance to the
primary user as well as clinicians/technicians who
set up the device.
The Addax is intended for infants, children and
adolescents who require postural support to
perform supported standing and activities with
the upper extremities. It is designed for users with
persistent, significant, or substantial functional
and/or structural disabilities that affect their
ability to stand independently. It is also suitable
for adults who fit within the dimensions of the
standing frame.

Intended environment

The devices are intended for indoor use, in home
environments or institutions. They are not to be
used outdoor and in wet areas.

Intended application

The user is the person standing in the device. The
caregiver is the person operating the device.
The cumulative sum of time of use (exposure) will
be either prolonged (more than 24 hours but less
than 30 days) or long-term (exceeding 30 days).
The use of the device will be discontinued multiple
times during the day when the user will be lying
down, sitting in another assistive device or a
conventional product.
The device is intended for use with intact skin
only. Depending on the configuration and the
accessories used, the contact will often be with
the skin of the head and neck region, shoulder
region, upper extremities and lower extremities of
the user and caregiver.
The device is intended for refurbishment and
reuse.
ENGLISH EN
Indications
The assistive devices in the R82 Standing Family
are indicated for children and adults who need
postural support to enable supported standing
due to a persistent, significant, or substantial
impairment of mobility, i.e., disability. The
indications for using the devices in the R82
Standing Family are based on functional ability
and not a specific health condition or age.
The Addax is indicated for users with impairments
in standing ability due to functional and/or
structural damage to the legs or the legs and
trunk muscles. This includes, but is not limited to,
conditions such as neurological or neuromuscular
diseases that result in postural instability and
incorrect posture.
Contraindications
There are no known contraindications.
Precautions
Precautions for use are based on known and
possible risks as identified in the R82 Standing
devices User Manuals and detailed in the R82
Standing device Risk Management as follows.
Cautions:
Special attention should be given to the
considerations about the configuration of the
device 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 device and its
accessories.
• Movement function (e.g. experience
involuntary movements).
• Ability to maintain a standing position, use the
device with accessories (e.g. chest or back
support).
• Ability to maintain the position of their head,
consider using accessories or to use a device
that provide support for positioning of the
head.
Enclosed tools:
• 5 mm Allen key.
Declaration of Conformity
This device conforms to the requirements of the
Medical Devices Regulation (2017/745).
The CE mark must be removed when:
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