BEFORE USING THE DEVICE, PLEASE READ THE FOLLOWING INSTRUCTIONS COMPLETELY AND CAREFULLY. CORRECT APPLICATION IS VITAL TO THE PROPER FUNCTIONING OF THE DEVICE.
INTENDED USER PROFILE: The intended user should be a licensed medical professional, the patient, the patient’s caretaker, or a family member providing assistance. The user should be able to read, understand and be physically capable to perform all the directions, warnings and cautions provided in the information for use.
INTENDED USE/INDICATIONS: Helps alleviate pain associated with Plantar Fasciitis. Soft-good/semi-rigid designed to restrict motion through elastic or semi-rigid construction.
CONTRAINDICATIONS: This product is not designed for the patient in a weight-bearing situation or everyday ambulation, or for patients allergic to Neoprene. Do not use if you are allergic to any of the materials contained in this product.
WARNINGS AND PRECAUTIONS:
- This device is to be prescribed and fitted by a healthcare professional.
- This device is not intended for unsupervised public use.
- If pain, swelling, changes in sensation, or other unusual reactions occur while using this product, you should contact your doctor immediately.
- Do not use over open wounds.
- Do not use this device if it was damaged and/or the package has been opened.
NOTE: Contact manufacturer and the competent authority in case of a serious incident arising due to usage of this device.
APPLICATION INFORMATION:
The splint should be applied with the patient seated. An absorbent sock may be worn on foot for additional comfort.
Preparation:
A. Ensure that the splint is “right side up” – the “toes” on the shell indicate where the foot is placed and the non-skid material should be positioned on the bottom, under the forefoot.
B. Loosen all the straps including the dorsiflexion pull strap at the front of the splint. It’s recommended the brace is applied like a sock. Loosen all straps without pulling through D-rings. Secure strap ends at the longest point back onto itself.
Application of splint:
- Slide the foot into the splint as if putting on a sock. Ensure that the toes and ball of the foot are comfortably positioned within the forefoot section of the splint and the heel is comfortably seated within the heel cut-out area. (Fig. 1)
- With the foot comfortably positioned in the splint, secure the forefoot straps first (Fig. 2), then the calf straps (Fig. 2a).
Then, if needed, tighten the middle straps (Fig. 2b). The straps should be snug, but not too tight. Do not over-tighten the straps. - For additional stretch on the Plantar Fascia, pull up on the dorsiflexion adjustment strap until the desired amount of stretch is achieved. (Fig. 3)
- The splint has a toe strap that serves to create a more snug fit, “wedging” the toes comfortably in the splint. This strap can be easily removed if desired (Fig. 4a).
Note: For ease in ambulation, release the dorsiflexion strap.
USE AND CARE
CLEANING INSTRUCTIONS: Liner may be removed and hand
washed with mild soap in cold water. Rinse thoroughly. AIR DRY.
WARNING: NEOPRENE SUPPORTS SHOULD NOT BE WORN BY INDIVIDUALS WITH KNOWN SUSCEPTIBILITY TO DERMATITIS OR ALLERGIES TO NEOPRENE BY-PRODUCTS.
FOR SINGLE PATIENT USE ONLY.
NOT MADE WITH NATURAL RUBBER LATEX.
WARRANTY: DJO, LLC will repair or replace all or part of the unit and its accessories for material or workmanship defects
for a period of six months from the date of sale.
NOTICE: WHILE EVERY EFFORT HAS BEEN MADE IN STATE-OF-THE-ART TECHNIQUES TO OBTAIN THE MAXIMUM COMPATIBILITY OF FUNCTION, STRENGTH, DURABILITY, AND COMFORT, THERE IS NO GUARANTEE THAT INJURY WILL BE PREVENTED THROUGH THE USE OF THIS PRODUCT.
 MDSS GmbHSchiffgraben 41 30175 Hannover Germany ©2020 DJO, LLC |  DJO, LLC 1430 Decision Street Vista, CA 92081-8553 • USA 13-2916 REV B 2020-12-07 |
