Section 01: Intended Use; Section 02: Certification; Section 03: Warnings And Cautions - Leckey Mygo Max User Manual

Mygo Max User Manual p4
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
The Mygo Max 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. There is one size; with
an approximate age range of 12-18
years with a maximum user weight
of 85kgs (187lbs). The configurable
postural support offered by the Mygo
Max is indicated for use for children and
young adults with moderate to complex
postural needs (GMFCS IV-V).
SECTION 02:
CERTIFICATION
Mygo Max 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!
SECTION 03: WARNINGS
AND CAUTIONS
1) Warning Toppling Hazard
•
Using the seat in extremes of
its range of positions will reduce
its stability. Only use the seat at
maximum height and/or maximum
seat recline when on level ground
(less than 2-degree slope).
•
When using the seat on slopes/
ramps (up to 10 degrees) ensure
that the seat back is in the upright
position and the seat height is below
half height.
2) Warning Finger Pinch Hazard
•
Take care that the fingers of the