Sunrise Medical Leckey Sleepform User manual

Sleepform
User Manual
Supporting
Children
English

p2 Sleepform User Manual
Sleepform supports a child in a
symmetric posture while they are
asleep and can be used reduce
the build-up of pressure points,
thus increasing comfort and the
likelihood of an undisturbed night’s
sleep for both them and their
family. It can be easily transported
so is ideal for use at home, holiday
or respite facilities and plays an
important part in 24 hour postural
management.
1 01 YEARS  COT
2 15 YEARS  COT
3 15 YEARS  SINGLE BED
4 518 YEARS  SINGLE BED

Sleepfrom User Manual p3
CONTENTS
01 Intended Use p.04
02 Certification p.04
03 Warnings and Cautions p.05
04 Terms of Warranty p.06
05 Product History Record p.06
06 Product Training Record p.06
07 Safety information p.07
08 Precautions and Contraindications p.08
09 Configuring the Sleepform system p.09
10 Cleaning and Care Information p.16
11 Daily Product Inspection p.16
12 Annual Product Inspection p.17
13 Re-Issuing Leckey Products p.18
14 Product Servicing p.18
15 Technical information p.19
16 Clinical Setup for Postural Management p.22

p4 Sleepform User Manual
SECTION 01:
INTENDED USE
SECTION 02:
CERTIFICATION
Intended Use
The Leckey Sleepform system is intended to
help prevent the long-term implications of
poor sleep postures.
Indications for use
The Leckey Sleepform system is designed to
support the needs of children with a variety
of disabilities which affect their ability to sleep
in a desirable posture/position. It is indicated
for use primarily within an indoor home
environment. There are four sizes, with a
maximum user weight of 19kg/42lbs (sizes 1 &
2) and 76kg/167.2lbs (sizes 3 & 4).
The postural support offered by the
Sleepform system is indicated for use for
children with moderate to complex needs
(GMFCS III-V).
The Sleepform 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.

Sleepfrom User Manual p5
SECTION 03:
WARNING AND
CAUTIONS
WARNING SUFFOCATION HAZARD
Always place the breathable mattress on top
of the mouldable base as the PVC material in
the base is not breathable and could present
a suffocation hazard to the user.
WARNING OCCUPANT SECURITY
The Leckey Sleepform system is intended to
encourage postural positioning only. Children
at risk of falling out of bed should always be
reliant on 3rd party bedframe designs.
WARNING SUDDEN INFANT DEATH
SYNDROME (SIDS)
The use of sleep positioning devices
with children under the age of 1 is not
recommended unless deemed safe and a
necessity by a qualified and experienced
health professional and a risk assessment has
been carried out. For more advice related to
SIDS, refer to external resources such as the
lullabytrust.org.uk or other reputable online
resources, your health visitor, paediatrician|
or GP.
CAUTION INFLATION
As with all valves, over time the valve will
allow inflation of the mouldable base and
result in reduced levels of support. The
mouldable base should be checked daily
and air extracted at least once per week.
CAUTION DAILY CHECKS
The Sleepform system should be checked
daily before use to ensure it is adequately
deflated and all additional supports and
accessories are securely fitted.
CAUTION CLEANING
Clean the product regularly in accordance
with the cleaning instructions outlined in this
document. Do not use abrasive cleaners.
Carry out maintenance checks on a regular
basis to ensure your product is in good
working condition.

p6 Sleepform User Manual
SECTION 04:
TERMS OF WARRANTY
SECTION 6:
PRODUCT TRAINING
RECORD
PARENTS, TEACHERS & CARERS
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 on
our website (https://www.leckey.com/
terms-and-conditions-of-sale). A three-
year warranty is provided on all Leckey
manufactured products and components.
SECTION 5:
PRODUCT HISTORY
RECORD
Your Leckey product is a medical device
and 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.
Your Leckey product is a prescribed Class
1 medical device and Leckey recommend
that parents, teachers and carers using the
equipment should be made aware of the
following sections of this user manual by a
technically competent person:
• SECTION 7 Safety Information
• SECTION 9 Configuring the Sleepform
System
• SECTION 10 Cleaning and Care
• SECTION 11 Daily Product Inspection
Leckey recommend that a written record
is maintained of all those who have been
trained in the correct use of this product.

Sleepfrom User Manual p7
SECTION 7:
SAFETY INFORMATION
7.1 Always read instructions fully before use.
7.2 Ensure that you have carried out an in-
depth risk assessment before issuing the
Sleepform system to your client.
7.3 Always place the breathable mattress
on top of the mouldable base as the
PVC material in the base is not breathable
and could present a suffocation hazard
to the user.
7.4 Ensure parents and carers are clear about
any potential hazards identified during
the risk assessment.
7.5 Only use Leckey approved components
with your product. Never modify the
product in any way. Failure to follow
instructions may put the user or carer at
risk and will invalidate the warranty on
the product.
7.6 If in any doubt to the safe use of your
Leckey product or if any parts should
fail, please cease using the product
and contact our customer services
department or your local dealer as soon
as possible.
7.7 Leckey products comply product
conforms to the Medical Device
Regulation (2017/745), UK Medical
Device Regulations 2002, Medical Device
Directive (93/42EEC) and EN 12182:2012
Assistive products for persons with
disability, general requirements and
test methods.
7.8 Clean the product regularly in
accordance with our cleaning instructions
outlined in this document. Do not use
abrasive cleaners. Carry out maintenance
checks on a regular basis to ensure your
product is in good working condition.
7.9 The product is designed for domestic
indoor use and when not in use should
be stored in a dry place that is not subject
to extremes of temperature. The safe
operating temperature range is +5⁰C
to +40⁰C.

p8 Sleepform User Manual
SECTION 8:
PRECAUTIONS AND
CONTRAINDICATIONS
Precautions
• Children under the age of 1 year
• Fixed spinal deformities such as scoliosis
or kyphosis
• Severe muscle contractures
• Severe muscular or skeletal asymmetry
including hip dislocation
• Progressive and muscle wasting
conditions
• High risk or recent history of bone
fractures
• High risk of pressure related injury or
open sores
• Strong, uncontrolled movement patterns
• Poorly controlled seizure activity
• Children dependent on the use of
percutaneous endoscopic gastrostomy
• Medical instability including
compromised respiratory or
cardiovascular function
• Dependant on 3rd party life-sustaining
apparatus such as oxygen tanks
• Significant learning disabilities and/or
behavioural issues
Contraindications
There are no contraindications associated
with the Leckey Sleepform product.
All precautions and contraindications are
taken at the discretion of the prescribing
clinician. Leckey recommends a trained and
experienced clinician to be present during the
initial assessment, set up, configuration and
re-issue to minimise risk.

Sleepfrom User Manual p9
SECTION 9:
CONFIGURING THE
SLEEPFORM SYSTEM
Parents and carers should be shown how to
make frequent adjustments and be made
aware of the safety checks in Section 7 by a
technically and clinically competent person
who has been trained in the use of the
product. Leckey recommend that a written
record is maintained of all parents and carers
who have been trained in the use of this
product.
The Sleepform system consists of a core: a
mouldable base and breathable mattress, and
optional supports to help create the desired
supported sleep position for the child.
Additionally, there are accessories to help with
incontinence and temperature regulation.
SLEEPFORM COMPONENTS
Core
Mouldable base
Optional Supports
Cushioned hip/chest guides and under
bed mattress straps
Pump
Breathable mattress

p10 Sleepform User Manual
Breathable knee pillow
(mainly used in side-lying)
Knee roll
Cushioned leg/knee guides and under bed
mattress straps
Accessories
• Temperature control sheet
• Waterproof mattress protector
Note: The particular
components chosen will
determine how the Sleepform
system is set-up