Section 01: Intended Use; Section 02: Certification - Leckey Pronestander User Manual

p4 Pronestander 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
Pronestander has been designed for
use at home or school. The range
of prone angles available allow the
gradual increases of weight bearing
as tolerance increases. Pronestander
is intended for children from the ages
1-17 years. 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 Pronestander 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!