Intended Use; Declaration Of Conformity; Terms Of Warranty; Product History Record - Leckey MyWay Pedal Mode D'emploi

SECTION 01:

INTENDED USE

The MyWay Pedal, which attaches to the
MyWay, enables children to pedal in an
upright position, working lower limb muscles
in the range of movement the child
would use during stepping and other
functional activities.
The Leckey Connect app captures movement
data to help measure a child's ability,
capture progress and compare
performance over time.
MyWay Pedal is intended for use by
children displaying an abnormal walking
pattern as a result of muscle weakness, or
who require a supportive walking device;
children with cerebral palsy GMFCS levels
II-IV (and possible level V depending on
range of movement); children displaying
crouch gait involving muscle imbalance/
anti-gravity weakness; children with general
low muscle tone, weakness and lack of joint
stability; children displaying asymmetry of
lower limb muscle tone or mild/moderate
hemiplegia; children pre or post-intervention
e.g. Botulinum Toxin treatment or long term
following lower limb surgery.
The MyWay Pedal is suitable for use with
the Size 2 and Size 3 MyWay. With the
Size 2, it is suitable for users up to 50kgs
and a shoulder height of 1090mm.
With the Size 3, it is suitable for users up to
80kgs and a shoulder height of 1390mm.
MyWay Pedal User Manual p5
SECTION 02:
DECLARATION
OF CONFORMITY
James Leckey Design Ltd as manufacturer
with sole responsibility declares that the
MyWay Pedal conforms to the requirements
of the 93/42/EEC Guidelines, Medical Device
Regulations 2002 and EN12182 Technical
aids for disabled persons and test methods.
SECTION 03:
TERMS OF WARRANT
The warranty applies only when the
product is used according to the
specified conditions and for the intended
purposes, following all manufacturers'
recommendations (also see general terms
of sales, delivery and payment).
A three year warranty is provided for
the MyWay Pedal, and a one year warranty
for the Leckey Connect device.
SECTION 04:
PRODUCT
HISTORY RECORD
Your Leckey product is classified as a Class
1 Medical device and as such should only
be prescribed, set up or reissued for use by
a technically competent person who has
been trained in the use of this product.
Leckey recommend that a written record is
maintained to provide details of all setups,
reissue inspections and annual inspections
of this product.