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

Sleepfrom User Manual p11
Scenario 1 (Core without optional supports)
1. Mould with child lying on mouldable base
2. Take child out
3. Place the breathable mattress on top of the mouldable base
4. Place accessories on top of the breathable mattress (Temperature control sheet, then
waterproof mattress protector)
5. Place standard bedsheet on top
6. Reassess to ensure child is comfortable and well positioned
Scenario 2 (Core with optional supports)
1. Position under bed mattress straps
2. Buckle chest/hip and leg/knee guides on top of mouldable base
3. Mould with child lying on base and using chest/hip and knee/leg guides
4. Take child out
5. Unbuckle and remove guides but leave under bed mattress straps in place
6. Place breathable mattress on top of base
7. Place accessories on top (Temperature control sheet, then waterproof mattress protector)
8. Place standard bedsheet on top
9. Position and re-buckle hip/chest and leg/knee guides
10. Position knee pillow or roll if using
11. Reassess to ensure child is comfortable and well positioned

p12 Sleepform User Manual
Core
Mouldable base & Pump
The mouldable base contains beads which
will form and retain a unique shape when
air is extracted using the pump provided.
The mouldable base is the core element to
provide support to the child.
Orientation
The mouldable base is designed in a ‘U’ shape
with one end having more beads - this is the
end which the valve is attached to.
The mouldable base should always be placed
in the middle of the bed with the channel in
the middle, either at the top or bottom.
To provide increased support at the lower
limbs, the U-Shape should be positioned
upwards. Alternatively, to focus on head
or trunk positioning, position the U-shape
downwards.
Attach nozzle
Deflation
U-shape facing
upwards to support
lower limb positioning
U-shape facing
downwards to support
head & trunk positioning

Sleepfrom User Manual p13
Open the value
Extract air
Close valve
To extract air from the mouldable base use
the hand pump. The slower you pull on the
handle, the quieter it will be. As you extract air
you will feel the base become less flexible. It
can be easier to mould if you have extracted
a small amount of air first.
When you have finished moulding the base
and extracting the air, close the valve before
removing the nozzle.
We recommend you check the mouldable
base daily and remove air at least once per
week if you find it is getting soft.
Inflation
To allow air into the base for remoulding,
simply open the valve with the pump nozzle
detached.

p14 Sleepform User Manual
Correct usage
Incorrect usage
OPTIONAL: If Attaching hip/chest
or leg/knee guides
To prevent the hip/chest or leg/knee straps
compressing the mouldable base it is advised
that these parts are attached over the base
during initial moulding This creates a channel
in the moulding for the belts. They can then
be removed and placed over the top of the
sheet for subsequent attachment to the child.
First, place the long strap(s) underneath the
bed’s mattress positioned roughly underneath
the desired area of use. Knowing your child’s
dimensions beforehand is beneficial.
Then when the underside straps are
positioned as desired, attach the Hip/chest
and Knee/Leg supports to the receiving ends.
Next mould the mouldable base to the
desired shape whilst creating small channels
in the mouldable base for each of the straps
to fall into.
Following this, unbuckle the Chest/Hip and
Knee/Leg supports from the receiving end.
These straps will be reattached when the
remainder of the Sleepform system has been
configured.

Sleepfrom User Manual p15
Placing a child into the configured
Sleepform
Place your child back onto the bed. Make
sure the mouldable base is not moulded too
tightly around your child. If it is too tight you
may have to open the valve and allow some
air into the base again. Always remember to
extract the air again once the desired shape
has been achieved. Finally close the valve and
remove the pump.
If using any of the chest/hip or knee/leg
supports, these can now be reattached to the
receiving buckles beneath the mattress.
Similarly, if the knee roll or knee pillow are to
be used, these can now be placed at your
child’s legs.
Breathable Mattress
The breathable mattress is an open celled
structure that provides a comfortable pressure
relieving support where air can flow freely
and prevent heat and moisture build up. The
breathable mattress is always used over the
mouldable base.
WARNING: The breathable
mattress must always be used
when using the mouldable
base. This is because the
mouldable base is an air-tight
support and could present as a
risk of suffocation to the child.
Note: The knee roll and knee
pillow ARE NOT attached to any
strap OR buckle.
Finally, fit a standard sheet over the breathable
mattress. For a single bed you may have to
use a double bed size sheet and for a cot you
may need to use a single bed size sheet – this
will depend on the components being used.
OPTIONAL: If using the
temperature control sheet
AND/OR waterproof mattress
protector
The temperature control is a technical fabric
which has been designed to help regulate
body temperature. The unique wax cells
absorb heat and keep the child cool. They
also store heat and keep you warm if you get
too cold. Simply place the cool sheet on top
of the breathable mattress. If an incontinency
sheet is being used it is best to place the cool
sheet under this to help prevent soiling.

p16 Sleepform User Manual
SECTION 10:
CLEANING AND CARE
INFORMATION
Leg/Knee Guides and Chest/Hip Guides
The whole component can be placed in
the washing machine and washed at 40
degrees Celsius.
Breathable Knee Pillow, Breathable
Mattress, Knee Rolls
The outer covers can be zipped off and
machined washed at 40 degrees Celsius.
The special fibre of the breathable mattress,
knee pillow and knee roll can be rinsed
clean under a tap/showerhead and air
dried. These will dry extremely quickly.
Additional or replacement covers are
available.
Mouldable base
Wipe clean with soap and warm water.
Allow the pillow to dry completely before
storing it. If necessary to disinfect, wipe the
complete pillow with a solution containing
70% alcohol. If your child occasionally
soils the bed, we recommend you use a
waterproof and breathable under sheet.
Temperature Control Sheet
The temperature control sheet can be
machine washed at 60 degrees Celsius.
SECTION 11:
DAILY PRODUCT
INSPECTION
We recommend that daily visual checks of
the equipment are carried out by therapists,
carers or parents to ensure the product is safe
for use. The recommended daily checks are
detailed below.
1. Check that the product is clean and there
are no signs of soiling.
2. Check that all fabrics, webbing, Velcro
and plastic buckles are in good condition
and do not show signs of wear and tear
or fraying.
3. Check the mouldable base is firm
enough to maintain your child in the
desired position; air can be extracted if
the mouldable mattress has become soft.
Should the child have lost the desired
position, the mouldable mattress should
be remoulded again to the desired
shape.
4. Check the mouldable base for scratches,
scores or punctures. Seal any holes with
the repair patches supplied with the
product.
Holes can be found by visual inspection or by
fully inflating the mouldable base, covering
the surface of the pillow with soapy water and
watching for air bubbles. If a hole has been
found clean the area and let it dry. Select
a patch and put glue on it and on the area
around the hole. Wait for 2 minutes and firmly
press the patch over the hole ensuring that
no air remains under the patch. The bond will
be complete after 24 hours. DO NOT FULLY
IMMERSE THE MOULDABLE BASE

Sleepfrom User Manual p17
SECTION 12:
ANNUAL PRODUCT
INSPECTION
Leckey recommend that each product
should be subject to a detailed inspection at
least one a year and every time the product
is reissued for use. This inspection should
be carried out by a technically competent
person who has been trained in the use of
the product and should include the following
checks as a minimum requirement.
1. Check that the product is clean and there
are no signs of soiling.
2. Check that all fabrics, webbing, Velcro
and plastic buckles are in good condition
and do not show signs of wear and tear
or fraying.
3. Check that all buckles lock securely when
clipped together.
4. Check the mouldable base is air-tight -
extract air and check that the product
does not lose its shape after the valve
has been closed.
5. Check the valve on the mouldable base
is working properly.
6. Check the mouldable base for scratches,
scores or punctures. Seal any holes
with the repair patches supplied with
the product. Holes can be found by
visual inspection or by fully inflating the
mouldable base, covering the surface
of the pillow with soapy water and
watching for air bubbles. If a hole has
been found clean the area and let it dry.
Select a patch and put glue on it and
on the area around the hole. Wait for 2
minutes and firmly press the patch over
the hole ensuring that no air remains
under the patch. The bond will be
complete after 24 hours. DO NOT FULLY
IMMERSE THE MOULDABLE BASE.
7. Check the breathable mattress is intact
and that the cushion is even and flat
and that it has not gathered in within
the cover.

p18 Sleepform User Manual
SECTION 13:
REISSUING LECKEY
PRODUCTS
Most Leckey products are assessed and
ordered to meet the needs of an individual
user. Before reissuing a product we
recommend that the therapist prescribing
the product has carried out an equipment
compatibility check for the new user and
has ensured that the product being re-
issued contains no modifications or special
attachments. A detailed technical inspection
should be carried on the product prior to
re-issuing. This should be carried out by
a technically competent person who has
been trained in the use and inspection of
the product. Ensure the product has been
cleaned thoroughly in accordance with the
cleaning and care section of this manual.
Ensure a copy of the user manual is supplied
with the product. A copy can be downloaded
from our website www.leckey.com
Leckey recommend that a written record is
maintained of all product inspections carried
out during the reissue of the product. If in
any doubt to the continued safe use of your
Leckey product or if any parts should fail,
please cease using the product and contact
our customer service department or your
local dealer as soon as possible.
SECTION 14:
PRODUCT SERVICING
Servicing of all Leckey products should only
be carried out by technically competent
persons who have been trained in the use of
the product. All international service enquiries
should be directed to the appropriate Leckey
distributor who will be delighted to assist you.
For further information on Leckey distributors
please visit our website www.leckey.com

Sleepfrom User Manual p19
SECTION 15:
PRODUCT SERVICING
Product Accessory codes
Sleepform Kit Size 1 110-1634
Sleepform Kit Size 2 110-2634
Sleepform Kit Size 3 110-3634
Sleepform Kit Size 4 110-4634
(includes Sleepform mattress, chest/hip guide, leg/knee guide and air flow mattress.)
Therapist Assessment Kit (Sizes 1 & 2)
(includes Chest/hip guides, leg/knee guides, air flow knee pillow, small & large knee rolls,
air flow mattress, Sleepform mattress.)
110-2635
Therapist Assessment Kit (Sizes 3 & 4)
(includes Chest/hip guides, leg/knee guides, air flow knee pillow, small & large knee rolls,
air flow mattress, Sleepform mattress.)
110-3635
Therapist Assessment Kit (Sizes 1-4)
(includes all sizes of chest/hip guides, leg/knee guides, air flow knee pillow, small & large knee
rolls air flow mattress, Sleepform mattress. All of the above comes with an extra Sleepform bag.)
110-1636
Chest/Hip Guide 110-1601
Leg/Knee Guide 110-1602
Chest/Hip Guide 110-2601
Leg/Knee Guide 110-2602
Air Flow Knee Pillow 110-2603
Knee Roll Large 110-2604
Knee Roll Small 110-2605
Air Flow Mattress 110-2606
Cot Attachment Strap 110-2609
Chest/Hip Guide 110-3601
Leg/Knee Guide 110-3602
Air Flow Knee Pillow 110-3603
Knee Roll Large 110-3604
Knee Roll Small 110-3605
Air Flow Mattress 110-3606
Single Bed Attachment Strap 110-3609
Chest/Hip Guide 110-4601
Leg/Knee Guide 110-4602
Sleepform Mattress (includes mattress, pump and Sleepform bag) 110-3607
Sleepform Pump NTL20
Sleepform Bag 10-3633
Temperature Control Sheet Sizes 1 & 2 110-2636
Temperature Control Sheet Sizes 3 & 4 110-3636
Waterproof Mattress Protector NTL27

p20 Sleepform User Manual
Product Dimensions
Component Size Dimension mm (Inches)
Sleepform Mattress One size 950 X 950mm (37.25” X 37.25”)
Airflow Mattress 1 & 2 960 X 1180 X 15mm(3775” X 46.5” X 0.6”)
3 & 4 1000 X 2000 X 30mm (39.4” X 78.75” X 1.2”)
Airflow Knee Pillow 1 & 2 230 X 330 X 60mm (9” X 13” X 2.4”)
3 & 4 450 X 650 X 60mm (17.7” X 25.6” X 2.4”)
Knee Roll 1 & 2 Small 140 X 50 X 500mm (5.5” X 2” X 19.7”)
1 & 2 140 X 100 X 500mm (5.5” X 2” X 19.7”)
3 & 4 195 X 75 X 900mm (7.7” X 3” X 35.4”)
3 & 4 195 X 125 X 900mm (7.7” X 5” X 35.4”)
Cushioned Chest & Hip
Guides min – max (mm) min – max (inches)
1Width 115 - 160 4.6 – 6.6
Circumference 345 - 485 13.8 – 19.4
2Width 160 - 196 6.4 – 7.8
Circumference 478 - 601 19.1 - 24
3Width 160 - 196 6.4 – 7.8
Circumference 478 - 601 19.1 - 24
4Width 175 - 328 7 – 13.1
Circumference 550 - 1007 22 – 40.2
Cushioned Leg & Knee
Guides min – max (mm) min – max (inches)
1Circumference 137 - 271 5.5 – 10.8
2Circumference 181 - 322 7.2 – 12.8
3Circumference 181 - 322 7.2 – 12.8
4Circumference 230 - 553 9.2 – 22.1
Under mattress Straps 1 & 2 630mm (24.8”) Strap length
3 & 4 1020mm (40.2”) Strap length
Temperature Control Sheet 1 & 2 810 X 1220mm (32.4” X 48.8”)
3 & 4 1000 X 2000mm (40” X 80”)
Waterproof Mattress Protecto One size 860 X 760mm (34” X 30”)
DIMENSIONAL & TECHNICAL DATA