Certification; Warning And Cautions - Leckey BeMe User Manual

SECTION 02:

CERTIFICATION

The Leckey BeMe is classified as a Class 1
Medical Device under EU and UK regulations.
As the manufacturer, James Leckey Design
Ltd, declares that this product conforms to
the Medical Device Regulation (2017/745),
UK Medical Device Regulations 2002, 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.
Leckey BeMe User Manual p5
SECTION 03:
WARNINGS AND
CAUTIONS
Note: Not following these instructions may
result in physical injury, damage to the
product or damage to the environment!
• Warning Toppling Hazard: Using the
high-low chassis and seat in extremes
of its range of positions will reduce its
stability. When using high-low chassis,
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 at its lowest.
• Warning Finger Trap Hazard: Take
care that the fingers of the operator or
children on the floor do not get trapped
in the raising and lowering mechanism of
the powered high-low chassis.
• Warning Occupant Security: Ensure that
when 2-point belt is used, webbing is fed
through the slot on the seat core above
the camlock.
• Warning Occupant Security: Ensure that
all the occupant harnesses and especially
the pelvic belts are fastened and
adjusted to hold the occupant securely in
place before moving the seat or leaving
the vicinity of the static seat.
• Warning Occupant Security: Dynamic
backrest should be set to "firm" when
BeMe is used in transportation.