Dorsi-Lite™ Foot Splint (Afo) Fits Children’S Feet

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USER INSTRUCTIONS FOR CHILDREN’S SIZE

DORSI-LITE™ FOOT SPLINT (AFO) FITS CHILDREN’S FEET. (US sizes 2 thru 13), (EU sizes 17 thru 31)

o Treats Foot Drop, Plantar Fasciitis, Achilles Tendonitis, Heel Spurs, and Shin Splints o Used With or Without Shoes for Most Daily Activities, and for Sleeping o Used Barefoot, or with Shoes, Booties, High-Tops, or Sandals o Water-Safe for Bathing, Swimming, Hydrotherapy o Tiny profile, Ultra-Light (1.2 oz.), Normal Ankle Mobility, Super Comfortable, Easy On/Off o Washable. Replacement fabric components available in the 3-Piece Set

CONTENTS Page 1. Product Description Page 2. Important User Information, Safety and Comfort, Care Instructions Page 3. Using the Dorsi-Lite™ Without Shoes Page 4. Using the Dorsi-Lite™ With Shoes, Sneakers, Sandals and Boots Page 5. Using the Dorsi-Lite™ With Shoes that Do Not Have Lace Holes and With Sandals Page 6. Helpful Hints: Making the Dorsi-Lite™ most Convenient to use, Trimming Excess Material Page 7. Replacing the Cuff on the Plastic Spine Page 8. Replacing the Strap and the Pad on the Plastic Spine

PACKAGE CONTENTS: One Dorsi-Lite™ Foot Splint. This device treats one foot.

PRODUCT DESCRIPTION

1. The children’s size Dorsi-Lite™ Foot Splint ankle foot orthosis (AFO) provides dorsi-flexion support and stabilization for the foot, and helps maintain the foot in a neutral position while at rest. This device can also be used as a night splint that is comfortable, secure, and which produces a near-normal gait for walking. 2. For use with many types of shoes, boots, high-tops, or sandals, normally in patients’ regular shoe sizes. Oversize and wider-than-normal shoes are rarely required. 3. The Dorsi-Lite™ can be used dry, like most braces, and it is also fully water compatible for use during bathing, showering, swimming and hydrotherapy. 4. This device fits children’s foot sizes. (US: kids’ sizes 2 thru 13) (EU: kids’ sizes 17 thru 31). 5. Replacement fabric components are available from X-Strap Systems, or online.

. X-STRAP® SYSTEMS 9 STONEGATE DRIVE, HYDE PARK, NY 12538 Phone: (845) 233-4713 FAX: (914) 931-1256 Web: www.x-strap.com

PAGE 2 IMPORTANT USER INFORMATION PLEASE READ BEFORE USING THE DORSI-LITE™

Information in the x-strap.com website, and in related documentation (hardcopy forms, brochures, user instructions, etc.) or photographs, or any type of digitized format, is intended to assist potential customers in making purchase decisions when evaluating our products without professional med ical advice. The website and related documentation only contain general information about the products offered for sale by X-Strap® Systems. Under no circumstances should this information be interpreted as medical diagnosis, opinion, or advice, which must only be provided by licensed medical providers, including doctors and therapists. The user’s safety and comfort are paramount!

!!! SAFETY AND COMFORT !!!

1. NEVER USE WITH A TIGHT OR A SNUG SHOE, AND NEVER OVER-TIGHTEN THE SHOE’S LACES OR CLOSURE STRAPS. 2. The Dorsi-Lite™ MUST be used with shoes that have shoelaces or Velcro Straps for closure. This device is not recommended for use with slip in shoes, slip-in boots, loafers, high boots, or with sandals that do not cover the instep sufficiently, as shown in Page 5. 3. The Dorsi-Lite™ should not be used during vigorous activities. 4. If pulmonary problems, or any medical conditions, other than foot drop, exist, get a physician’s or therapist’s approval prior to use. 5. REMOVE THE LOWER STRAP BEFORE USING WITH ANY KIND OF SHOE OR SANDAL. 6. Ensure that the cushioning Pad, at the bottom end of the plastic Spine, is not wrinkled when the DORSI-LITE™ is inserted into the shoe. 7. Apply only as shown in these User Instructions. Apply snuggly. DO NOT OVERTIGHTEN! 8. Fabric components wear out over time. Replace worn straps before product failure occurs. 9. Please read “Care Instructions” in order to maximize the user’s experience. See Page 1. 10. If this device does not fit comfortably, adjust the Strap and/or the Cuff for a more comfortable fit. If discomfort continues, discontinue use, call us for help, or return the device for a refund. 11. Trim excess strap lengths with sharp scissors after proper application See Page 6. 12. The amount of time this device can be worn continuously will vary by individual. For new users, the best personal schedule should be determined over the first week or two of use. 13. Children with larger foot sizes may need to use the larger, adult size Dorsi-Lite™. 14. The Dorsi-Lite™ will not be effective and/or comfortable for all individuals. Users with a high instep may feel discomfort at the top of the foot. If this happens, call us for help. 15. Any alteration of Dorsi-Lite™ components (other than trimming extra strap material), is a misuse or misapplication of the device, and may cause serious injury. X-Strap® Systems, the manufacturer, will not be responsible for damages or injuries caused by misuse or misapplication of the device. IF YOU ARE NOT SURE ABOUT SOME ASPECT OF THE DORSI-LITE™, CALL US! (845) 233-4713

CARE INSTRUCTIONS WASHING: Only HAND WASH the Dorsi-Lite™ fabric components. • Remove all fabric components from the plastic Spine, squeeze them gently in warm water and mild soap. • To rinse, squeeze the components under cold running water until all soap is gone, then squeeze the components to remove additional moisture. DO NOT WRING! • Press flat between a towel to remove additional moisture, then lay flat to air dry.

STRAP REPLACEMENT: The Dorsi-Lite™ fabric components should be inspected regularly (we suggest weekly), to identify and make repairs, when needed. Worn or damaged components should be replaced with new ones, to ensure continued comfort and safety. See Pages 7-8 for instructions showing how to easily attach fabric components to the plastic Spine.

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USING THE DORSI-LITE™ WITHOUT SHOES

TO USE THE DORSI-LITE™ WITHOUT SHOES, BOTH THE CUFF (worn around the ankle), AND THE STRAP (worn around the foot), MUST BE USED.

1. Fully open both the Dorsi-Lite™ Cuff and Strap’s Velcro® connection. Do not separate the cuff and strap from the Instep Image plastic spine.

2. As shown in Fig. 1, hold the Dorsi-Lite™ with the UP^ INSTEP CUFF arrow pointing up, and place the plastic Spine over the top of the foot (the instep, see image at right) and against the front of the ankle. Move it around a bit to

seat it comfortably. 3. As shown in Fig. 2, while holding the Dorsi-Lite™ in this position, elevate the forefoot, slightly stretch the Strap, located at the bottom end of the Spine, and smoothly wrap it under the foot, and then continue wrapping it around and over the top of the foot, until the Strap locks onto the Velcro® strip that is sewn to the Strap FIG. 1 itself. N OTE: Strap fit should be SNUG, NEVER TIGHT! PLASTIC SPINE 4. Center the Dorsi-Lite™ on the foot comfortably, then slightly PAD stretch and wrap the Cuff, at the top end of the plastic (Attached to up Velcro R Back of Spine) Spine, around the back of the leg, and continue wrapping it completely around the ankle, until it locks Velcro R CUFF onto the exposed Velcro® strip at the front of the Spine. Continue wrapping the Cuff in the same direction until sock it locks onto the Velcro® strip that is sewn to the Cuff STRAP itself. NOTE: Cuff fit should be SNUG, NEVER TIGHT! 5. T EST FOR GOOD SUPPORT AND COMFORT. With the Strap and Cuff applied snuggly and FIG. 2 comfortably, have the user take a few steps to test this setting. If an adjustment to the fit is needed for improved support and/or comfort, re-apply the Strap and/or the Cuff, then test the fit again. Repeat as CUFF needed to optimize the fit. NOTE: NEVER MAKE THE CUFF AND STRAPS TIGHT Strap Around up SUGGESTION: Once the Strap has been applied Foot snuggly around the foot, as described above, additional adjustments are normally made by adjusting the fit of the Cuff.

NOTE: Figs. 1 & 2, above, show the Dorsi-Lite™ with the Cuff and Strap aligned to the left. This causes the Strap and the Cuff to close at the left side of the leg, and is normally used for the left leg. See Pages 7 & 8 for setting Strap and Cuff closure to either the left or the right side.

• NEVER USE THE LOWER STRAP WHEN USING WITH ANY TYPE OF SHO E. • Do not use with a tight or a snug shoe, and never over-tighten the shoe’s closures. • If a pressure point occurs, using a different shoe may solve the problem. • Do not use with loafers, slip-in shoes, or slip-in boots. • Do not use with shoes that have heels higher than ½”. • SEE PAGE 5 for use with sandals and with shoes that close using Velcro® straps.

1. First remove the Strap completely from the lower end of the Dorsi-Lite’s™ plastic Spine by breaking its Velcro connection. See Fig. 3.

ATTENTION: FAILURE TO REMOVE THE STRAP WHEN USING THE DORSI-LITE™ WITH ANY KIND OF SHOE MAY CAUSE SEVERE INJURY TO THE FOOT!!!

2. Open the shoe’s laces, or Velcro® straps widely to allow for easy entry, then slip the shoe over the foot.

3. Lift the tongue and slip the lower end of the plastic Spine over the top of the foot (the instep), and under the tongue *. Ensure that the cushioning pad at the underside of the Spine does not wrinkle when you do this. See Fig. 4.

4. Pull the sock up fully to get rid of any wrinkles that could cause discomfort, then center the Dorsi-Lite™ on the foot, then tie the shoelaces, or close the shoe’s Velcro® straps snuggly. DO NOT OVERTIGHTEN THE LACES OR THE VELCRO® STRAPS.

5. With the foot in the shoe and the shoelaces tied (or the straps closed), slightly stretch, then wrap the Cuff around the back of the leg, and continue wrapping it completely around the ankle, until it locks onto the exposed Velcro® strip at the top of the Spine. Continue wrapping the Cuff in the same direction until it locks onto the Velcro® strip sewn to the Cuff itself. See Fig. 4.

* Alternatively, the bottom end of the plastic Spine may be placed on top of the tongue and under the shoelaces (or under the shoe’s Velcro® straps). We recommend that you try both ways to determine which results in the best fit and the most comfort. With shoes that have no tongue, the bottom end of the Spine should be placed on the top of the sock and under the shoelaces, or the under shoe’s Velcro® straps.

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USING THE DORSI-LITE™ WITH SHOES THAT DO NOT HAVE LACE HOLES AND WITH SANDALS

THE DORSI-LITE™ MUST BE USED WITH SHOES WHERE THE TIGHTNESS OF THE FIT CAN BE ADJUSTED BY USING EITHER SHOELACES OR VELCRO® STRAPS FOR CLOSURE.

The Dorsi-Lite™ can be used with many types of shoes that use VELCRO® straps for closure, but it is not compatible with ALL such types of shoes. Here are examples of shoe and sandal designs that may not work well with the Dorsi-Lite. Note that sandals must provide su cient coverage over the instep in order for this device to work safely.

> RECOMMENDED STYLES

Fig. A shows an example of a strapped shoe or sandal that has sufficient instep coverage to hold the Dorsi-Lite™ safely.

> POSSIBLY USEFUL

Fig. B shows a shoe with less robust instep coverage than seen in Fig. A. You will have to try it to determine if it produces enough foot lift.

Fig. C shows a shoe that may not provide enough instep coverage to provide safe support. You will have to try it to determine if it works effectively.

NOT RECOMMENDED: SLIP-IN SHOES AND LOAFERS

Fig. D, a slip-in shoe or a loafer, is NOT RECOMMENDED since the shoe’s tightness cannot be controlled via shoelaces or Velcro® straps. This will result in too little support if the shoe is loose, and can result in severe damage to the foot if the shoe is tight.

MAKING THE DORSI-LITE™ MOST CONVENIENT TO USE

By using Velcro®, the DORSI-LITE's™ Strap and Cuff can easily be connected to the ™ left side of the plastic Spine for closure on the left, or to the right side, for closure on the right.

For the right leg,the strap and cuff are normally aligned to the right, as in Fig. A. See pages 7 & 8.

For the left leg, the strap and cuff are normally aligned to the left, as in Fig. B. See pages 7 & 8.

TRIMMING EXCESS ½ STRAP MATERIAL

The Strap and Cuff are made long enough to fit large children. Users of a new DORSI-LITE™ may trim excess material away, as follows, if needed. First put the DORSI-LITE™ on, and ensure a good fit. See Page 3. a. TO SHORTEN THE STRAP, use sharp scissors to cut off extra strap material, keeping 1-2 inches of excess material beyond the point where the Strap contacts the Velcro® strip for closure. b. TO SHORTEN THE CUFF, use a piece of tape to mark the line where the Cuff locks to the Velcro® strip that is sewn to the Cuff. Take the ½ DORSI-LITE™ off. With scissors, carefully trim the cuff, making the Cuff 1-2 inches LONGER than indicated by the tape.

NOTE: Any alteration of Dorsi-Lite™ components (other than trimming extra strap material), is a misuse or misapplication of the device, and may cause serious injury. X-Strap® Systems, the manufacturer, will not be responsible for damages or injuries caused by misuse or misapplication of the device.

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REPLACING THE CUFF ON THE PLASTIC SPINE

The Cuff is attached to the plastic Spine with Velcro®, and is removable for cleaning, or for replacement* with a new Cuff, when the time comes.

For the right leg, the strap and cuff are normally aligned to the right, as in fig. A. For the left leg, the strap and cuff are normally aligned to the left, as in fig. B. YOU CAN EASILY SWITCH FROM LEFT TO RIGHT, FOR ANY REASON, IN SECONDS!

REMEMBER: - THE ^UP ARROW ON THE PLASTIC SPINE INDICATES THE TOP AND FRONT OF THE DORSI-LITE™. - ALL CONNECTIONS BETWEEN THE PLASTIC SPINE AND THE FABRIC COMPONENTS ARE MADE WITH VELCRO®. - THE SMOOTH NYLON SIDE OF THE FABRIC COMPONENTS ALWAYS FACES AWAY FROM THE SPINE.

ATTACHING THE CUFF TO THE PLASTIC SPINE

FIG A. For Use on Right Foot, Attach Cuff TO ALIGN THE CUFF TO THE RIGHT (normally for the to Spine Aligned to the Right RIGHT foot), See Fig. A. CUFF UP Press the Velcro® side of the Cuff (the end with the SMOOTH NYLON Velcro® piece sewn to it) onto the Velcro® strip at the SIDE UP

R RIGHT side of the front of the spine. The edge of the cuff VELCRO SEWN should overlap the spine's Velcro® strip by about 1/2 TO CUFF inch. The smooth nylon side of the cuff should face away from the spine. Edge of Cuff R VELCRO ShouldR Overlap Velcro Strip on STRIPS Spine by 1/2 Inch. TO ALIGN THE CUFF TO THE LEFT (normally for the SPINE LEFT foot), See Fig. B. BOTTOM Press the Velcro® side of the Cuff (the end with the Velcro® sewn to it) onto the Velcro® strip at the LEFT FIG B. For Use on Left Foot, Attach side of the front of the spine. The edge of the cuff should Cuff to Spine Aligned to the Left overlap the spine's Velcro® strip by about 1/2 inch. The smooth nylon side of the cuff should face away from the UP spine. CUFF SMOOTH NYLON SIDE UP NOTE: *Replacement parts, including the Cuff, the VELCRO R SEWN Strap, and the cushioning Pad, are available for TO CUFF purchase as the 3-Piece Fabric Components Set.

R Edge of Cuff VELCRO Should Overlap STRIPS R  Cuff around the ankle Velcro Strip on Spine by 1/2 Inch.  Strap around the foot SPINE  Comfort Cushion Pad

BOTTOM

REPLACING THE STRAP AND/OR THE PAD ON

THE PLASTIC SPINE

The Strap and the Pad are attached to the spine with Velcro®, removable for cleaning, or for replacement w ith new components, when the time comes.

NOTE: Left and right sides, as discussed below, are based on user’s perspective when applying the DORSI-LITE. ATTACHING THE STRAP ALIGNED TO THE RIGHT SIDE OF THE SPINE

TO ALIGN THE STRAP TO THE RIGHT (for the right FIG A. foot), press the end of the Velcro® side of the Strap For use on the Right Foot. UP onto the Velcro® strip at the bottom end of the Spine. Attach Strap to Spine Aligned to See Fig. A. The edge of the Strap should overlap the the Right SPINE Spine's Velcro® square completely. The smooth nylon side of the Strap (with the Velcro® strip sewn to it) STRAP VELCRO R should face away from the Spine. w/ smooth nylon side up BOTTOM

ATTACHING THE STRAP ALIGNED TO THE LEFT SIDE OF THE SPINE

TO ALIGN THE STRAP TO THE LEFT (for the left , press the Velcro® side of the Strap onto the FIG B. foot) Velcro® strip at the bottom end of the Spine. See Fig. UP For use on the Left Foot.

B. The edge of the Strap should overlap the Spine's Attach Strap to Spine Aligned to SPINE the Left Velcro® square completely. The smooth nylon side of the Strap (with the Velcro® strip sewn to it) should R face away from the Spine. VELCRO STRAP

BOTTOM w/ smooth nylon side up TO ATTACH THE PAD

Attach the Velcro® side of the cushioning Pad (this component has NO Velcro® strips sewn to it), to the Velcro® pieces on the back side of the plastic Spine, stretching it slightly, and centering it horizontally and vertically on the spine. The smooth nylon side of the pad should face away from the Spine.

 NOTE: Replacement parts, including the Cuff, the Strap, Cuff around the ankle and the cushioning Pad, are available for Strap around the foot  purchase as the 3 -Piece Fabric Components Set. Comfort Cushion Pad 