Leckey Freestander, User Manual

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p4 Freestander User Manual
SECTION 01:
INTENDED USE
Intended use
The devices are intended to assist
children that cannot stand or maintain
a standing position independently as
part of a supported weight bearing
program.
Indications for use
Freestander has been designed for
used at home or in school for upright
standing. The stander is available
in three sizes catering for the needs
of children from the age of 1-18.
Size 1 has a maximum user weight
a maximum user weight of 60kgs
(132lbs), size 2 80kgs (176lbs) and the
size 3 90kgs (198lbs). Suitable for:
• Children and adults with disabilities
such as Cerebral Palsy, traumatic
brain injuries, muscular dystrophy and
other conditions where supported
standing programs are encouraged.
• Children presenting with
developmental delay who are
currently non-ambulating.
• Children where early intervention is
indicated.
SECTION 02:
CERTIFICATION
The Freestander is classified as a
Class I Medical Device under EU and
UK regulations. As the manufacturer,
James Leckey Design Limited, declares
that this product conforms to the
Medical Device Regulation (2017/745),
UK Medical Device Regulations 2002,
Medial Device Directive (93/42 EEC)
and EN 12182:2012 Assistive products
for persons with disability, general
requirements and test methods.
Notice to the user and/or patient: Any
serious incident that has occurred
in relation to the device should be
reported to the manufacturer and the
competent authority of the Member
State in which the user and/or patient
is established.
NOTE:
General user advice.
Not following these
instructions may result in
physical injury, damage to
the product or damage to
the environment!