Leeway Pelvic Cradle User Manual

Introduction

Inspired by harnesses used in windsurfing, the Leeway Pelvic Cradle is designed for individuals who would benefit from increased pelvic stability and control. Its snug fit provides unsurpassed proprioceptive feedback, and combined with a 4-point attachment, it holds and supports the user, giving them the confidence to move their center of gravity freely. This improves dynamic sitting ability and increases sideways and forward reach while keeping the base of support stable.

Adjustable Velcro tabs on each side accommodate a range of postures and shapes. Adjusting these tabs forward can encourage a more upright posture with neutral or anterior pelvic tilt. The Leeway Pelvic Cradle is rigid yet flexible, with a polycarbonate insert ensuring it retains its shape when not in use, making transfers into the wheelchair simple. Carefully positioned neoprene sections allow the front strap to spring out of the way when the buckle is undone.

Contents

• 01 Intended Use
• 02 Certification
• 03 Warnings and Cautions
• 04 Terms of Warranty
• 05 Product History Record
• 06 Product Training Record
• 07 Safety Information
• 08 Precautions and Contraindications
• 09 How to Attach
• 10 Clinical Setup
• 11 Cleaning & Care Information
• 12 Daily Product Inspection
• 13 Annual Product Inspection
• 14 Re-issuing Leckey Products
• 15 Product Servicing
• 16 Technical Information

Section 01: Intended Use

The Leeway Pelvic Cradle (patent pending) is a pelvic harness that provides maximum security, stability, and comfort to wheelchair users. It secures the user to their wheelchair at four key points, giving them the confidence to move their upper bodies freely without fear of falling. Available in 4 sizes from pediatric through to adult, and with 2 buckle choices, the Leeway Pelvic Cradle can be easily attached to a wide range of manual and powered wheelchair bases.

Section 02: Certification

The Leeway Pelvic Cradle is classified as a Class I Medical Device under EU and UK regulations. James Leckey Design Limited declares that this product conforms to the Medical Device Regulation (2017/745), UK Medical Device Regulations 2002, Medical 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.

Section 03: Warnings and Cautions

Warning Occupant Security

• User transfers in and out of the product must be done with appropriate equipment and personnel.
• When transferring the user into the product, first use the pelvic cradle to secure the user.
• Ensure that all straps are securely applied.
• If the user exhibits any form of distress, remove from the product as quickly as is safely possible.
• Ensure that the pelvic cradle is fastened and adjusted to hold the occupant securely in place before moving the seat or leaving the vicinity of the static seat.
• Users should not be left unattended at any time whilst using Leckey equipment.

Caution Finger Pinch Hazard

• While the user is in the product, the carer should strive to keep product adjustments to a minimum.
• Take care when assembling or adjusting the position of the product so that fingers do not get pinched when positioning components and tightening fixings.
• During transfers and adjustments, the carer should avoid the finger nipping risk of buckles.

Caution Daily Checks

• The product is to be checked daily before use to ensure that all components are securely attached and safe for use.

Caution Cleaning

• Clean the product regularly to prevent the build-up of dirt. Accumulated dirt can prematurely wear the fabric components and encourage corrosion on the product. Only use non-abrasive household cleaners and moist cloths; do not use running water on the upholstery whilst it is still attached to the product. See Cleaning & Care Information in the user manual.

Caution Cleaning Power washer/Hoses

• Hoses and power washers are not to be used to clean the product. See Cleaning & Care Information in the user manual.

Caution Disposal

• When disposing of the product using a community waste disposal site, the components should be disposed of separately where appropriate.

Caution Bringing into Use

• Before use, allow 2 hours for the product to acclimatize to room temperature.

Section 04: Terms of Warranty

The warranty applies only when the product is used according to the specified conditions and for the intended purposes, following all manufacturer's recommendations. A three-year warranty is provided on all Leckey manufactured products and components.

Section 05: Product History Record

Your Leckey product is classified 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 recommends that a written record is maintained to provide details of all setups, reissue inspections, and annual inspections of this product.

Section 06: Product Training Record (Parents, Teachers & Carers)

Your Leckey product is a prescribed Class 1 Medical Device. Leckey recommends that clients and carers using the equipment should be made aware of the following sections of this user manual by a technically competent person:

• Section 07 Safety Information
• Section 10 Clinical Setup
• Section 11 Cleaning and Care Information
• Section 12 Daily Product Inspection

Leckey recommends that a written record is maintained of all those who have been trained in the correct use of this product.

Section 07: Safety Information

1. This Leeway Pelvic Cradle is designed for postural positioning and should not be used as the sole means of securing the user to the vehicle during transportation, nor as a method of restraint.
2. Leeway Pelvic Cradle should be installed and fitted by a technically competent person.
3. Always read instructions fully before use.
4. Only use Leckey approved components with your product. Failure to follow instructions may put the user or carer at risk. The length of webbing may be modified to suit the wheelchair base. Modifying the product in any other way will invalidate the warranty.
5. If in any doubt about the continued safe use of your product or if any parts should fail, please cease using the product and contact our customer services department or local dealer as soon as possible.
6. The product contains components which could present a choking hazard to small children. Always check that locking knobs and bolts within the child's reach are tightened and secure at all times.
7. Leckey products comply with fire safety regulations in accordance with EN12182. However, the product contains plastic components and therefore should be kept away from all direct sources of heat, including naked flames, cigarettes, electric and gas heaters.
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.

Section 08: Precautions and Contraindications

Precautions

• 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 Seating product family.

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, configurations, and re-issues in order to minimize risk.

Section 09: How to Attach

Congratulations on purchasing your Leeway Pelvic Cradle. Your harness will arrive with a Velcro seat base strap and 4 triglide brackets (additional attachment kits are available). Please remove the harness and attachments from the packaging and ensure you have all the parts you have ordered. The following fitting instructions are only a guideline, as seating systems vary according to manufacturer.

9.2 Attach the Side and Rear Mounting Straps

The two side mounting straps (A) should be positioned approximately vertically and attached to the wheelchair frame using suitable fasteners.

The two rear mounting straps (B) should be positioned approximately diagonally to ensure the Leeway Pelvic Cradle is positioned correctly. The straps should be attached to an appropriate part on the wheelchair frame using suitable fasteners.

Diagram showing side mounting straps attached vertically to a wheelchair frame.

Diagram showing rear mounting straps attached diagonally to a wheelchair frame.

9.3 Attachment Examples

The mounting straps may be looped around a suitable part on the frame and secured with a triglide (A). The triglides are supplied as standard.

The P-clips (B) are suitable for round tube frames of 19, 22, or 25mm diameter. These clamps provide a mounting position for the eyelets on the mounting straps.

Diagram showing a mounting strap secured with a triglide.

Diagram showing P-clips attached to a wheelchair frame.

The mounting straps (C) may be fastened directly onto the wheelchair at suitable pre-drilled locations on the frame.

The slot anchor plate (D) may be fastened directly onto the rear of the wheelchair frame.

For some wheelchairs where round tubing is not available, the folded plate (E) can be secured to the frame and the cam buckle secured vertically to the folded plate.

9.4 Securing the Leeway Pelvic Cradle Onto the Seat

Velcro the base of the Leeway Pelvic Cradle onto the seat base strap and secure the 4 side release buckles. Adjust the webbing length on both the Leeway Pelvic Cradle and mounting straps, as required.

Diagram showing the Leeway Pelvic Cradle attached to a wheelchair seat.

Section 10: Clinical Setup

10.1 Preparing for the Client

When setting up the Leeway Pelvic Cradle for the first time, it should be flat with the Velcro side tabs open. All four side and back buckles should already be attached to the seat.

10.2 Positioning the Client in the Leeway Pelvic Cradle

Position the client into the seat and establish the correct posture with the front strap of the Leeway Pelvic Cradle positioned at the inguinal crease. As a check, if the Leeway Pelvic Cradle is too far forward, it will be too low on the user's back; conversely, if it is too far back, it will be too high up the user's back.

10.3 Securing the Client in the Leeway Pelvic Cradle

There are two buckle options: the standard side release (A) and the security buckle (B), which has a secure three-point release requiring two fingers and a thumb to open. Fasten your chosen buckle at the front of the Leeway Pelvic Cradle. Adjust the tension using the D-rings to provide a snug fit. If it is difficult to secure this buckle, check that the user is positioned well back in the seat/Leeway Pelvic Cradle. Re-positioning or an alternative size of Leeway Pelvic Cradle may be required.

Next, fasten the Velcro tabs (C) at the sides to fit the Leeway Pelvic Cradle to the user. An anterior, neutral, or posterior pelvic tilt can be achieved depending on the clinical needs of the client.

Diagram showing the side release buckle.

Diagram showing the security buckle.

Diagram showing Velcro tabs being fastened.

10.4 Final Adjustments

Finally, adjust the front and rear straps (A and B) to secure and position the user's pelvis.

After initial setup, only the front buckle needs to be released when the user is transferred in or out of their seating system. The front buckle should be the first item to be secured upon entering the seat and the last item to be released upon leaving the seat.

! Warning: Once a week, check that the Leeway Pelvic Cradle has not become slack.

Diagram showing adjustment of front and rear straps.

Diagram showing the security buckle being released.

Diagram showing the front buckle being secured.

Section 11: Cleaning & Care Information

How to Maintain

When cleaning the product, use only warm water and a non-abrasive detergent. Never use organic solvents or dry cleaning fluids.

Upholstery and Fabrics

The Leeway Pelvic Cradle may be washed in the washing machine at 40°C. Drip dry. Do not iron. Placing the Leeway Pelvic Cradle inside a cloth bag during washing may help prevent scratches to the product and machine.

1. The upholstery and fabrics can be cleaned by hand whilst in place. When cleaning, use only warm water and a non-abrasive detergent.
2. The best cleaning method is a 'wipe & dry' technique.
3. Staining should be removed as quickly as possible with absorbent cloth, towels, or a sponge. Routine soap and warm water sponging is effective for ordinary soiling and minor spills. Be careful not to over-wet the fabric, as this will cause the staining to spread.
4. Antiseptic cleaning agents can be used on more stubborn stains. These may require a safe solvent such as isopropyl alcohol or mineral spirit. A half cup of household bleach to 5 litres of water can also be used as a useful disinfectant.
5. Always ensure the product is dry before use.

Section 12: Daily Product Inspection (Therapists, Parents & Carers)

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 all upholstery for signs of wear and tear.
2. Check all Velcro strips and brush fluff to ensure straps secure firmly.

! Warning: If in any doubt about the continued safe use of your Leckey 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.

Section 13: Annual Product Inspection (Therapist, Technician, Leckey Product Advisor, Dealer)

Leckey recommends that each product should be subject to a detailed inspection at least once 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 and inspection of the product and should include the following checks as a minimum requirement:

1. Check all plastic buckles are in place and replace any missing items.
2. Pay particular attention to the Velcro.

Please refer to section 13 for the required checks to be carried out.

Ensure the product has been cleaned thoroughly in accordance with section 11 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 recommends that a written record is maintained of all product inspections carried out during the reissue of the product.

! Warning: If in any doubt about the continued safe use of your Leckey 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.

Section 14: 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 reissued contains no modifications or special attachments.

A detailed technical inspection should be carried out 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. Please refer to section 13 for the required checks to be carried out.

Ensure the product has been cleaned thoroughly in accordance with section 11 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 recommends that a written record is maintained of all product inspections carried out during the reissue of the product.

Section 15: 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.

In the UK & ROI, please contact the Leckey Service Centre on UK 0800 318265 or ROI 1800 626020. Our customer service department will be delighted to assist you with your servicing requirements.

Section 16: Technical Information

Product Sizing

Accessories

The Leeway Pelvic Cradle comes as standard with the Velcro seat base strap and four triglide brackets.

Additional Attachment Kits:

• 147-1602: Quick release attachment kit (Contains 4 straps with side release buckles and 4 'p' clips)
• 147-1604: Mobility seat base plate attachment kit (Contains 4 straps with side release buckles and 2 angle brackets)
• 147-1603: Seat base strap

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.

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