Leckey MyWay Pedal User Manual

MyWay Pedal
with Leckey Connect
User Manual
Supporting Children
p2 Leckey MyWay Pedal
The MyWay Pedal, which attaches to the MyWay, enables children to pedal in an upright position, working lower limb muscles in the range of movement the child would use during stepping and other functional activities.
MyWay Pedal is integrated with Leckey Connect which captures movement data. This is displayed via the MyWay Pedal App using a android smartphone, tablet or via our online portal.
CONTENTS
01 Intended use p.03 02 Declaration of conformity p.03 03 Terms of warranty p.03 04 Product history record p.03 05 Product training record p.04 06 Safety information p.05 07 Contra-indications & cautions p.06 08 Attaching pedal to MyWay & setting up for user p.07 09 Removing user & detaching MyWay Pedal from MyWay p.15
10 Using pedals for the rst time p.16
11 Leckey Connect Setup p.17 12 Conduct Endurance Session p.20 13 Conduct Sprint Session p.22 14 Review Previous Sessions p.23 15 Logout p.25 16 Reset Password p.25 17 Delete Child Account p.25 18 Reassign Child’s Therapist p.26 19 Delete Therapist Account p.26 20 Web Portal Login p.26 21 Review Data p.26 22 Troubleshooting p.27 23 Cleaning and care information p.28 24 Daily Inspection p.29 25 Annual Inspection p.30 26 Re-issuing p.31 27 Servicing p.32 28 Technical Information p.32
Leckey MyWay Pedal p3
SECTION 02: SECTION 01: INTENDED USE
The MyWay Pedal, which attaches to the MyWay, enables children to pedal in an upright position, working lower limb muscles in the range of movement the child would use during stepping and other functional activities.
The Leckey Connect app captures movement data to help measure a child’s ability, capture progress and compare performance over time.
MyWay Pedal is intended for use by children displaying an abnormal walking pattern as a result of muscle weakness, or who require a supportive walking device; children with cerebral palsy GMFCS levels II-IV (and possible level V depending on range of movement); children displaying crouch gait involving muscle imbalance/ anti-gravity weakness; children with general low muscle tone, weakness and lack of joint stability; children displaying asymmetry of lower limb muscle tone or mild/moderate hemiplegia; children pre or post-intervention e.g. Botulinum Toxin treatment or long term following lower limb surgery.
The MyWay Pedal is suitable for use with the Size 2 and Size 3 MyWay. With the Size 2, it is suitable for users up to 50kgs and a shoulder height of 1090mm. With the Size 3, it is suitable for users up to 80kgs and a shoulder height of 1390mm.
DECLARATION
OF CONFORMITY
James Leckey Design Ltd as manufacturer
with sole responsibility declares that the
MyWay Pedal conforms to the requirements
of the 93/42/EEC Guidelines, Medical Device
Regulations 2002 and EN12182 Technical
aids for disabled persons and test methods.
SECTION 03:
TERMS OF WARRANT
The warranty applies only when the
product is used according to the
specied conditions and for the intended
purposes, following all manufacturers’
recommendations (also see general terms
of sales, delivery and payment).
A three year warranty is provided for the
MyWay Pedal, and a one year warranty for
the Leckey Connect device.
SECTION 04:
PRODUCT
HISTORY RECORD
Your Leckey product is classied as a Class
1 Medical device and as such 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.
p4 Leckey MyWay Pedal
5. PRODUCT TRAINING RECORD
(Parents, Teachers & Carers)
Your Leckey product is a prescribed Class 1 Medical Device and as such 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 6
SAFETY INFORMATION
SECTION 7
CONTRAINDICATIONS & CAUTIONS
SECTION 8 – 10
ATTACHING PEDAL TO MYWAY & SETTING UP FOR USER
SECTION 11 – 22
LECKEY CONNECT APP
SECTION 23
CLEANING AND CARE
SECTION 24
DAILY INSPECTION
SECTION 06: SAFETY INFORMATION
Leckey MyWay Pedal p5
6.1 Always read user instructions fully before use.
6.2 Users should not be left unattended at any time whilst using Leckey equipment.
6.3 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.
6.4 If in any doubt to the continued safe use of your product or if any parts should fail, please cease using the product and contact our Customer Care Team or your local dealer as soon as possible.
6.5 Carry out all relevant positional adjustments and ensure that they are securely fastened before you put the user into this product.
6.6 Never leave the product on a sloping surface, greater than 5 degrees. Always remember to lock all the castors.
6.7 The product contains components which could present a choking hazard to small children. Always check that locking knobs and bolts within the user’sreach are tightened and secure at all times.
6.8 Clean the product regularly. Do not use abrasive cleaners. Carry out maintenance checks on a regular basis to ensure your product is in good working condition.
6.10 The product should be stored carefully
and not used if any parts are faulty.
6.11 Leckey products comply with fire safety
regulations in accordance with EN12182.
MyWay Pedal satisfies the requirements of
EN1021-1. However the product should be
kept away from all direct sources of
heat including naked flames, cigarettes,
electric and gas heaters.
6.12 The product is designed for indoor
and outdoor use on smooth, level surfaces.
The product is not suitable for use on
uneven or rough terrain. When not in use,
the product should be stored in a dry
place that is not subjected to extremes
of temperature. The safe operating
temperature range of the product is
+0° to +40° Celsius.
6.13 If product is to go unused for
6 months or more, batteries should
be removed.
6.14 The data presented by the app is
for reference only. Therapists should use
their own professional judgement when
determining appropriate therapy and
activity for a child.
6.15 Ensure no loose clothing can come
in contact with the moving parts of the
pedals. (eg shoe laces, loose trousers)
6.16 This Leckey Connect device should
not be used in an oxygen rich environment.
6.9 Failure to follow the user instructions may put the child at risk.
p6 Leckey MyWay Pedal
SECTION 07: CONTRA-INDICATIONS & CAUTIONS
Please review the contra-indications and cautions highlighted in the MyWay user manual. The following apply, in addition to those for the MyWay, when using the MyWay Pedal.
Contra-indications:
• Children with significant leg length
discrepancy or asymmetry which precludes from reciprocal contact with the sandals when pedalling.
• Children with cardio-respiratory conditions
which may be exacerbated by aerobic exercise such as pedalling.
Cautions:
• Closely supervise child at all times during use.
• Never force pedal movements when child’s feet are placed in sandals.
• For use on flat surfaces only – not for uneven ground or gradient.
• Ensure children displaying hyperextension of knees out of the device flex knees as pedals rise.
• Ensure no harness slippage for children with device fed through the abdominal wall, such as PEG, gastrostomy, or abdominal device in situ such as Baclofen pump.
• Ensure children with compromised respiratory function, who may experience increased effort of breathing due to fit of harness are breathing freely (for physiotherapist to monitor effort of breathing, colour and respiratory rate).
• Ensure child does not initially over-use the MyWay Pedal without build-up of tolerance as this presents a risk of muscle strain.
• Review use of MyWay Pedal for children with significant learning disability or behavioural issues with risk of possible injury to the child and/or carer.
• The data presented by the app is for reference only. Therapists should use their own professional judgement when determining appropriate therapy and activity for a child.
SECTION 08:
2 3
3
2
2 3
3
2
2 3
3
2
ATTACHING PEDAL TO MYWAY & SETTING UP FOR USER
SECTION 8.1: ATTACH SANDAL
Leckey MyWay Pedal p7
Unfasten the knob and remove washers from sandal bolts.
A
For size 2 sandals – feed the bolts through the holes numbered ‘2’ on the MyWay Pedal. For size 3 sandals – feed through the holes numbered ‘3’.
B
Apply rubber washer, metal washer and then fasten knob. Repeat for all 4 bolts.
2 3
2
3
2 3
2
3
C
A
B
C C
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SECTION 8.2: REMOVE HANDLEBAR
A
Release quick clamp A and lift handlebar upwards to remove.
B
If doing with child in product, ensure to protect their face from contacting the handlebar.
SECTION 8.3: APPLY COVER TO HANDLE RECEIVER
A
Remove cover from steering column and turn upside down.
B
Wrap around handle receiver
and fasten Velcro tabs.
C
Fold the third Velcro tab down to totally cover handle receiver.
Should be used when handle bar is removed to protect user from contacting steering column.
A
B
B
C
SECTION 8.4: RELEASE H–BRACKET
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A
Release the two quick clamps.
B
Slide the h-bracket to its
minimum position.
A
A A
SECTION 8.5: TRANSFERRING USER INTO MYWAY
There are two scenarios for transferring the user into the MyWay.
1. Transfer user into MyWay before pedals
are attached (recommended)
2. Transfer user wearing harness in
after pedals have been attached. (If using this method see Section 8.6 before doing so.)
Support the user to step onto the pedals. First, connect the harness to the MyWay. Then secure the user’s feet into the sandals.
2 332
2 332
2 332
2 332
B B
Warning - If user is not
capable of sufcient weight
bearing, a hoist should be used to transfer them into the MyWay.
It’s recommended that 2 people assist with transfers.
p10 Leckey MyWay Pedal
SECTION 8.6: POSITION MYWAY PEDAL
A
Apply the brakes on all 4 wheels of the MyWay frame.
If attaching whilst user is in the MyWay, have a second person lift the user’s legs up and away from the area in which the pedals will be positioned.
B
Bring the MyWay Pedal to the MyWay frame from behind and position the clamps under the horizontal of the MyWay frame. (When attaching to S2 MyWay, you will have to slightly lift the MyWay Pedal at the front for the clamps to fit under the MyWay frame horizontal.)
A
B
C
Raise H-bracket so that the MyWay frame horizontal nestles in the clamp.
D
Attach the clamp to the MyWay frame by placing the top section of the clamp over the frame tube, slot the lever into the top section and then close the lever.
C
Ensure the 4 wheels of the MyWay frame and the 2 wheels of the MyWay Pedal are on the ground. If all the MyWay wheels are not, push down on the MyWay frame horizontal to correct wheels are not, push down on the brace bar below the H-bracket to correct.
G
Tighten the H-bracket levers.
E
. If all the pedal
F
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E
G G
F F
G
E
SECTION 8.7: ADJUST USER HEIGHT
The MyWay Pedals raise the user 10cm off the ground. Set height at approx 5cm higher than for MyWay without pedals and use fine height adjustment to optimum height for child to achieve active pedalling.
A
A
to raise
Ensure MyWay pulley straps are clipped up, to avoid them contacting the wheel.
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