Leckey Squiggles Operation & User’s Manual

The Squiggles+ Stander has been designed to offer the support your child needs in an upright, forward leaning (prone) or rearward leaning (supine) standing posture. The stander is modular in design and which have been developed for use in school or at home. This manual shows how to quickly, safely and easily use your Squiggles+ Standing Frame functions. The instructions on the safety and maintenance will ensure that you will enjoy this product for a long time.

Contents 1. Intended Use p.03 2. Declaration of Conformity p.03 3. Terms of Warranty p.04 4. Product History Record p.04 5. Product Training Record p.04 6. Safety Information p.05 7. How to unpack and assemble the standing system p.06 8. Fitting the cushions p.11 9. Clinical setup for postural management p.15 10. Frequent adjustments for daily use p.23 11. Cleaning & care information p.27 12. Daily product inspection p.28 13. Annual product inspection p.29 14. Reissuing Leckey products p.30 15. Product servicing p.30 16. Technical information p.31 1.0 Intended Use The Squiggles+ Stander is a standing frame which has been designed for children with disabilities aged 1–5 for use at home or in the classroom. The maximum user weight regardless of which chassis is used is 22kgs (48.4lbs). 2.0 Declaration of Conformity Declaration of Conformity James Leckey Design Ltd. as manufacturer with sole responsibility declares that the Squiggles+ Standing System conforms to the requirements of the 93/42/EEC Guidelines Medical Device Regulations 2002 and EN12182 Technical aids for disabled persons. General requirements and test methods.

4.0 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 recommend that a written record is maintained to provide details of all set-ups, reissue inspections and annual inspections of this product. 5.0 Product Training Records (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: 3.0 Terms of Warranty 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). A three year warranty is provided on all Leckey manufactured products and components. 6.0 Safety 10.0 Frequent Adjustments for Daily use 11.0 Cleaning and Care Information 12.0 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.

6.0 Safety Information 6.1 Always read 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 local dealer as soon as possible. 6.5 Carry out all positional adjustments and ensure that they are securely fastened before you put the user into this product. Some adjustments may require the use of a tool which is provided with each product. Keep all tools out of reach of children. 6.6 When putting the user into the stander both for positional and safety reasons, always secure the pelvic and chest support harnesses first. 6.7 When the product is stationary ensure that all castors are locked and facing away from the base as this will improve product stability. This is especially important when the support frame is in a reclined position. 6.8 When the product is in use please ensure that the angle adjustment foot pedal are locked off and cannot be adjusted accidentally, especially if there are children in the area. 6.9 When the Leckey Squiggles + Stander is used on the Pivot chassis we do not recommend that users is moved over uneven surfaces when in the equipment. All due care and attention should be taken if transporting the user in and out of the stander. 6.10 Never leave the product on a sloping surface, greater than 5 degrees. Always remember to lock all the castors. 6.11 Although the Pivot stander is fitted with castors this is not a mobility device. Always place the user in an upright position before moving the stander. Hold the push handle when moving the stander. 6.12 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. 6.13 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. 6.14 Do not place hot objects greater than 40ºC on the tray. 6.15 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.

6.0 Safety 6.16 The product is designed for indoor use and when not in use should be stored in a dry place that is not subjected to extremes of temperature. The safe operating temperature range of the product is +5 to +40 deg Celsius. 6.17 Please be aware of a gap on the underside of the tray where a child could insert their finger between the metal bracket and the base of the plastic tray. 7.0 How to unpack & assemble the standing system 7.1 Folding and unfolding the pivot chassis The Pivot Chassis can be easily folded for storage or transportation. To unfold, release the levers shown by pressing them together, rotate the rear tubes until the levers engage in the locked position. To fold the chassis simply reverse this procedure. Always remove the standing support frame before trying to fold the chassis. Always use caution to ensure fingers do not become trapped when folding and unfolding the pivot chassis.

The Squiggles + Stander can be used as a prone, supine or upright stander and has been designed to fit with a pivot chassis. 7.2 Attaching stander to pivot chassis To attach the stander to the Pivot Chassis, pull the locking pin out , slide the central spine into the receiving bracket until it is fully engaged, release the pin allowing it to snap back into place. Always make sure the locking pin is fully engaged before you place the child in the stander.

7.3 Attaching the headrest To attach the Leckey headrest first open the locking lever by pressing the safety button and pulling the handle . Then slide the stem into the receiving bracket on the central spine, set to the desired position and secure using the locking handle. 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. 7.4 Inserting attachment bolt Insert the required attachment bolt along with the retention plate . Place a rubber lid on, both, the top and bottom of the sandal. Fasten using the four screws provided. To remove or replace the attachment bolt, reverse this process.

7.5 Attaching the sandals Place the sandal so that the attachment bolt goes through the slot in the footplate. To secure, on the underside of the footplate place the rubber washer , followed by the metal washer and then the knob onto the attachment bolt. To position the sandals simply loosen the knob under the footplate, select the position you require and re-fasten the knob. 7.6 Assemble the tray To attached the arms to the tray brackets, loosen the knob, place the moulding to the inside of the tray plate so the plastic teeth mesh. Replace the knob on the outside and secure. Repeat on other side. Ensure both horizontal tubes are aligned so they locate in the tray bracket receivers. Please be aware of a gap on the underside of the tray where a child could insert their finger between the metal bracket and the base of the plastic tray.

7.7 Attaching the tray in prone and supine The tray is attached to the stander by inserting the tubes into the receiving brackets. Once the tray is located in position the knobs should be tightened. The cut out of the tray should always be facing the child. To attach the tray whilst in the prone version, ensure that the tray receiving tubes are at their maximum height. 7.8 Attaching the grab rail To attach the grab rail, inset the receiving brackets in the tray slot and secure with the plastic knob . Repeat on the other side and then sleeve the tubes into the tube and tighten the plastic knob . Always use caution to ensure the child’s hands or arms do not become trapped when inserting the tray. Supine Prone

8.1 Hip cushions Place the cushion centrally on the chest/hip support plate . Feed the upper tab, which has the Velcro attached, over the top of the moulding and Velcro in place. Bring the lower tab under the support and attach the upper tab using the Velcro panels . 8.2 Lateral cushions To attach the lateral support padded cushions, simply slide the cushions on with the padded side towards the inside of the stander. Sleeve the plastic buckle through the slot in the cover. Then fasten poppers together at the back. 8.0 Fitting the Cushions

8.3 Chest support harness The Chest support can be attached by clipping the male buckle into the female buckle at either side of the lateral supports. 8.4 Pelvic harness To attach the pelvic harness, simply slide the left and right sides of the harness over the lateral supports. Sleeve the plastic buckles through the slots in the harness . Then fasten the poppers together at the back of the harness. Finally pull the Velcro receiving straps around the user to secure the user in the harness. 8.5 Hip Support harness The hip support should be attached around the pelvic harness as an additional safety support should the Velcro on the pelvic harness begin to wear. It can be attached by clipping the male buckle into the female buckle at either end of the pelvic harness. To adjust the tension lift the front panel, adjust the straps to the required length and then replace the panel.

8.6 Knee support pads Open the knee supports fully. Insert child’s knee into place . Wrap small strap over the knee, then bring the longer wrap over to ensure a snug fit over the knee . Velcro in place and secure with buckle . Once knee is in correct position, secure cam-lock for further repeatability. 8.7 Padded Spine Cap Place the padded spine cap over the spine of the standing support and place the plastic loops around the adjustment knobs. 8.8 Headrest cushion To attach the headrest cushion, place the cushion onto the head support plate, then Velcro and bring the lower flap under the plate and Velcro the two fasteners in place.

8.9 Headrest Laterals To attach the headrest lateral covers, simply slide the covers on with the padded side towards the inside of the stander . Then fasten the poppers together at the back. Clinical setup for postural management 9 The clinical setup of the product should be completed by a technically and clinically competent person who has been trained in the use of the product. Leckey recommend a written record is maintained of all clinical set-ups for this product.

9.0 Clinical setup for postural management 9.1 Setting the Height Set the height first by placing the child in a lying position on a mat. Measure the distance from the child’s feet to their hips. The height between the centre of the hip moulding and the top of the sandal should be set to this height by adjusting the leg support. Measure the distance from the child’s feet to just under their axilla and the height between the top of the chest support and the sandal should be set to this distance. Adjust this distance by adjusting the hip support. It’s recommended to adjust the height whilst the frame is in an upright position 9.2 Adjusting the overall height The overall height of the standing support can be adjusted by loosening the bolt on the back of the main frame with the multi-tool . Sliding the inner stem to the desired height and re-tightening the allen bolt. A calibration strip is fitted on the side of the inner frame to help you record the selected positions of the supports. There is also a safety stop at the maximum height. Never attempt to adjust the height of the main frame when the stander is in use. WARNING: Adjust the overall height after step 9.1 and without the user in the product.

9.3 Adjusting the push handle The push handle height can be adjusted by loosening the Allen bolt at the attachment point to the stander, adjusting to the desired height then re-tightening the Allen bolt. The angle of the push handles can be adjusted by loosening lever at the attachment point to the stander. Rotate the push handle to the desired position, then secure the lever to original orientation. 9.4 Adjusting the chest and hip supports To adjust the chest support rotate both knobs in an anticlockwise direction as shown. Set to the required position and then re-tighten both knobs in a clockwise direction as shown . To adjust the hip support loosen the 4 locking bolts (2 either side) . Rotate both knobs in an anticlockwise direction as shown. Set to the required position and re-tighten both knobs in a clockwise direction as shown . Finally re-tighten the 4 locking bolts. Always use caution to ensure fingers do not become trapped when adjusting the chest and hip supports. To prevent finger nipping always hold the push handle with one hand whilst making the adjustment with your other hand.

9.5 Lateral supports Loosen the hand knob to adjust the width of the lateral supports and re-tighten when you have achieved the desired position. If, the lateral supports are attached with bolts instead of hand knobs they can be adjusted with the multi tool. 9.6 Adjusting the pelvic harness To adjust the pelvic harness pull the Velcro receiving straps around the user until the desired position is achieved. 9.7 Chest and hip support harness To change the width of the chest harness, lift the front cover, adjust the Velcro straps and set to the desired width and replace the cover. Always use caution to ensure fingers do not become trapped when adjusting the lateral supports. Always make sure the plastic buckles are fully engaged when using the chest harness.

9.8 Adjusting the sternum pad The sternum pad can be raised to provide additional support to assist thoracic extension. This also allows the chest support to be set lower to enable greater freedom of arm movement. The sternum plate is adjusted by loosening the two bolts at the front of the chest plate with the multi-tool, set to the desired height and re-tighten. 9.9 Adjusting the height, depth and angle of the knee cups Each knee cup can be positioned independently. To adjust the height, depth and angle of the knee cups, loosen knob , select the height, angle and depth required and re-tighten the knob securely. To adjust the width of the knee cup loosen knob , set to the desired width then re-tighten. Always use caution to ensure fingers do not become trapped when adjusting the sternum pad.

9.10 Headrest adjustment The headrest should only be used when the child is in supine standing. To adjust the height, depth and angle of the contoured headrest, loosen the hand knobs and when set to the desired position re-tighten the knobs. 9.11 Flat headrest lateral adjustment To adjust the width of the laterals loosen plastic knob to desired position and tighten securely. Always use caution to ensure fingers do not become trapped when height adjusting the headrest.

9.12 Sandals positioning To position the sandals simply loosen the knob under the footplate, select the position you require and re-fasten the knob. To position the user’s feet in the sandals secure the Velcro straps provided so the foot is held in place. The straps should be placed over the bridge of the foot and over the toes. The front strap can be fed through one of two slots on either side of the sandals, depending on the size of the user’s feet. 9.13 Footplate angle adjustment To set the angle to accommodate plantarflexion and dorsiflexion, simply loosen or tighten the knob to set the desired angle. If the child is wearing sandals or light footwear check the straps to make sure the webbing does not irritate the skin.

9.14 Adjusting for abduction Loosen levers on each leg support. Adjust leg support to desired angle as displayed on the angle indicator. Re-tighten levers. 9.15 Product conversion – supine to prone To convert the Squiggles+ Supine Stander to accommodate prone standing, simply remove the headrest as outlined under “Attaching the Headrest” and attach the tray with the cutout facing the child. Loosen the sandals and turn through 180 degrees. Rotate the handle downwards (see 9.3) and you are ready for prone standing. 9.16 Product conversion – prone to supine To convert the Squiggles+ Prone Stander to accommodate supine standing, simply attach the head support as outlined under “Attaching the Headrest” and attach the tray with the cutout facing the child. Loosen the sandals and turn through 180 degrees and you are ready for supine standing. 10 20 25 15 5 0

9.17 Adjusting the height of the tray in prone and supine The height adjustment knobs for the tray are located on either side of the central spine. Loosen the 2 knobs , select the required height and re-tighten. 9.18 Adjusting the depth and angle of the tray Loosen the adjustment knob on either side, slide the tubes along the receiving brackets to achieve the desired depth and re-tighten the knobs. To adjust the angle of the tray loosen the knobs on either side of the tray, set the tray to the required angle and re-tighten securely. Never use the tray to steer or push the chair. Do not place hot objects on the tray, greater than 40 degrees Celsius. Please note that the tray is for the use of the user only. Do not lean or place heavy objects on the tray greater than 8kgs (17.6lbs)

Always secure the hip and chest support harnesses first. 10.0 Frequent adjustment for daily use (therapists/carers/parents) 10.1 Transferring the user into and out of the stander Before transferring the child into the stander carry out the daily product inspection as outlined in section 12 of this user manual. Before transferring the child into the product lock all the castors , ensuring that they are facing outwards to maximise product stability. Make sure the straps on the chest, hip support harnesses and sandals are released and out of the way to facilitate transfer. To facilitate transfer into supine standing, angle the support frame to its most horizontal position. This will enable easier positioning of pads and straps while the child is lying on their back. Parents and carers should be shown how to make frequent adjustments and made aware of the safety checks in section 6 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 parent and carers who have been trained in the use of this product.

10.2 Chest and hip support harness To open the chest or hip support harness unclip one buckle and move the harness to one side leaving the other buckle attached. Reverse the process when placing the user back in the product. 10.3 Sandals To position the user’s feet in the sandals secure the Velcro straps provided so the foot is held in place. The straps should be placed over the bridge of the foot and over the toes. The front strap can be fed through one of two slots on either side of the sandals, depending on the size of the user’s feet. Always secure the chest and hip support harnesses first before making other adjustments. Always make sure the plastic buckles are fully engaged. If the child is wearing sandals or light footwear check the straps to make sure the webbing does not irritate the skin.

Never use the tray to steer or push the chair. Do not place hot objects on the tray, greater than 40 degrees Celsius. Please note that the tray is for the use of the user only. Do not lean or place heavy objects on the tray greater than 8kgs (17.6lbs) 10.4 Adjusting the height of the tray in prone and supine The height adjustment knobs for the tray are located on either side of the central spine. Loosen the 2 knobs , select the required height and re-tighten. 10.5 Adjusting the depth and angle of the tray Loosen the adjustment knob on either side, slide the tubes along the receiving brackets to achieve the desired depth and re-tighten the knobs. To adjust the angle of the tray loosen the knobs on either side of the tray, set the tray to the required angle and re-tighten securely.

10.7 Grab rail adjustment To set the depth of the grab rail to suit the child’s reach loosening knob adjust to the required depth and then re-tighten. To set the height of the rail, loosen knob slide the rail to the required height and then re-tighten. 10.8 Pivot chassis angle adjustment The angle can be adjusted whilst the user is in the stander. You should ensure the child is secured in the stander using the thoracic and hip pads. To adjust the angle of the stander first release the locking pin. To release the pin, pull and rotate plastic knob through 90 degrees into the locked position. Press the foot pedal down and set the stander to the desired angle using the handle bars. Always re-lock the locking pin . Ensure that the product and user are away from surrounding furnishings to prevent possible collision when adjusting the angle of the pivot chassis.

11.0 Cleaning & Care Information How to Maintain When cleaning we recommend that you use only warm water and a non-abrasive detergent. Never use organic solvents or dry cleaning fluids. Upholstery and fabrics 1. The upholstery and fabrics can be cleaned by hand whilst in place. When cleaning we recommend that you 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. Metal and plastic components 1. Soap and water or antibacterial spray can be used for daily cleaning. 2. For deep cleaning a low pressure steam cleaner can be used. 3. Do not use solvents to clean plastic or metal components. 4. Make sure the product is dry before use.

12.0 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 recommend daily checks are detailed below. 1. Ensure all adjustment knobs and bolts are in place and secure. 2. Check all upholstery for signs of wear and tear 3. Check all castors are moving freely and lock securely 4. Check all Velcro strips and brush fluff to ensure straps secure firmly. 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 Care Team or your local dealer as soon as possible.

13.0 Annual Product Inspection (Therapist, Technician, Product Specialist, Dealer) Leckey recommend 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 of the product and should include the following checks as a minimum requirement. 1. Check all knobs, nuts, bolts and plastic buckles are in place, replacing any missing items. Paying particular attention to the following items; > Headsupport locking bolts > Chest and hip height and angle adjustments > Knee cups adjustment knobs and straps > Footrest angle adjustment 2. Check the chassis folding and angle adjustment mechanism is working properly. Also, check that the locking pin on the Pivot Chassis engages securely in the pedal. 3. Lift the base to check each castor individually. Make sure they are moving freely and remove any dirt from the rubber wheels. Check that the brakes lock the wheels securely. 4. Visually check the structure of the product paying attention to weld points on the frame ensuring there are no signs of fatigue or cracking around the welds. 5. Leckey recommend that a written record is maintained of all annual product inspections. 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 Care Team or your local dealer as soon as possible.

14.0 Re-issuing Leckey Products 15.0 Product Servicing 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. 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 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 Care Team or your local dealer as soon as possible. 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.

16.0 Technical Information Product and Accessory Codes 184-600 Stander support 184-764 Pivot Chassis 184-1800-02 Stander covers – Blue 184-1800-04 Stander covers – Purple 184-1800-09 Stander covers – Red 184-1800-09VIN Stander covers – Red Vinyl Accessories Codes prefixed by an asterix are available in four colour options. 02 – Blue 04 – Purple 09 – Red 09VIN – Red Vinyl 152-1600 Size 1 Sandals 152-2600 Size 2 Sandals 118-619 Tray 117-769 Grab Rails 118-697 Headrest Support *184-1814 Headrest cushion with laterals 118-687 Headrest laterals Age (approx.) 1-5 Max User Weight 22kg / 48.4lbs User Height - Min 730mm / 28.5 inches Max 1100mm / 43.3 inches Chest Support Height (Distance from footplate to armpit) Min 160mm / 6.25 inches Max 820mm / 32 inches Chest / Hip Width - Min 160mm / 6.25 inches Max 230mm / 9 inches Hip Support Height (Distance from footplate to mid-buttock) Min 300mm / 11.8 inches Max 530mm / 20.8 inches Distance between mid line of knees - Min 140mm / 5.5 inches Max 215mm / 8.4 inches Footplate - Plantarflexion 100 Dorsiflexion 100 Pivot chassis angle range - 90-180º Pivot chassis angle range 90 - 70º Tray height - prone - Min 555mm / 21.9 inches Max 825mm / 32.5 inches Tray height - supine - Min 480mm / 18.5 inches Max 825mm / 32.5 inches Pivot chassis footprint (Minimum dimensions for storage) Min 5.5kg / 12.1lbs Width 550mm / 21.7 inches Length 700mm / 27.6 inches Height 300mm / 11.8 inches Standard support frame (Minimum dimensions for storage) Min 7kg / 15.4lbs Width 380mm / 15.4 inches Length 890mm / 26.8 inches Height 380mm / 15.4 inches

Lisburn BT28 2SA Northern Ireland United Kingdom T: 028 9260 0750 F: 028 9260 0799 E: [email protected] W: www.leckey.com