p4
Mygo Seat - Size 3 Stander User Manual
SECTION 01:
INTENDED USE
Intended use
Leckey’s seating systems are
intended to support children and
young adults who have mild to
complex postural needs that affect
the ability to sit without additional
support.
Indications for use
Mygo Seat – Size 3 is a modular
seating system designed to cater for
the needs of children with a variety of
disabilities which effect their ability
to sit independently without external
postural supports. It is indicated for
use primarily within a home, indoor
school environment or outdoors, if
used on a mobility base. Mygo Seat –
Size 3 has an approximate age range
of 10-16 years, with a maximum
user weight of 70kgs (154lbs). The
configurable postural support offered
by Mygo Seat – Size 3 is indicated for
use for children with moderate to
complex postural needs (GMFCS IV-V).
SECTION 02:
CERTIFICATION
Mygo Seat – Size 3 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!