Leckey MyWay+ - 1.0 Intended Use; 3.0 Warnings and Cautions; 3.1 Warning | Toppling Hazard; 3.2 Warning | Finger Trap Hazard

p.4 MyWay+ User Manual
2.0 Declaration of Conformity
The MyWay+ is classied as a Class I Medical Device under EU and UK regulations. James
Leckey Design Ltd as manufacturer with sole responsibility declares that the Leckey MyWay+
conforms to the requirements of the 93/42/EEC Guidelines, Medical Device Regulations 2017,
UK Medical Devices Regulation 2002 and EN 12182 Technical aids for disabled persons 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!
• MyWay+ is an upright
mobility device that
supports children, who
cannot stand or walk
independently, in an
upright position and
allows them to move
about their environment.
• MyWay+ is intended
for children and young
people with a physical
disability/ gross
motor delay which
prevents them from
independent upright
mobility; for children
and young people with
Cerebral Palsy (or other
equivalent conditions) in
GMFCS levels III- V (who
have sufcient range of
movement in their lower
limbs to enable passive/
active stepping).
• The MyWay+ Size 1
frame is suitable for
users up to 25kg and
a shoulder height of
870mm; the Size 2 frame
is suitable for users up
to 50kg and a shoulder
height of 1190mm;
and the Size 3 frame
is suitable for users up
to 80kg and a shoulder
height of 1490mm.
Please see section
8.0 Contra-indications/
Cautions’ for further
information.
3.0 Warnings and Cautions
3.1 Warning | Toppling Hazard
•
Never use the product on
a sloping surface greater
than 5 degrees or on
uneven or rough terrain.
•
Always brake the castors
before placing the user in
the product.
•
Possible tip hazard for
users of max height for
each frame size, where the
user is capable of lifting
frame off ground. Risk
assessment to be carried
out to assess suitability of
user.
3.2 Warning | Finger Trap
Hazard
•
Ensure that the user or
carer does not touch any
moving joint or pivot that
is not locked.
1.0 Intended Use