Intended Use; Certification - Leckey Squiggles Stander User Manual

p4 Squiggles Stander - 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
Squiggles Stander is a standing frame
which has been designed for children
aged 1-5 for use at home or in the
classroom. The standing support frame
can be used on the Pivot chassis.
The Pivot chassis has been designed
for indoor use on level surfaces. The
maximum user weight regardless of
which chassis is used is 22kgs (48.4lbs).
Suitable for:
• Children 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 Squiggles Stander 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!