DJO Malleoforce plus (With strap) knitted ankle support Instructions
MalleoForce® Plus
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
The DonJoy MalleoForce is designed to support the ankle. It may be suitable for use following an ankle sprain, soft-tissue injury, or loadrelated pain in the foot and ankle and, may help with instabilities and mild osteoarthritis. Soft-good/semi-rigid designed to restrict motion through elastic or semi-rigid construction.
INDICATIONS
- Post-operative or post-traumatic use, chronic soft tissue inflammation in the ankle area
- Feelings of instability
- Sprains
- Ligament injuries, ligament weaknesses
- Load-related pain in the foot and ankle
- Joint effusions
- Swelling
- Mild Osteoarthritis
PERFORMANCE CHARACTERISTICS
Soft-good/semi-rigid designed to restrict motion through elastic or semi-rigid construction.
CONTRAINDICATIONS
Do no use if you are allergic to any of the materials contained in this product.
The MALLEOFORCE/MALLEOFORCE PLUS Ankle Support should only be used after consulting a health care professional if you suffer from the following symptoms:
- Skin diseases and injuries in the ankle area (e.g. allergy-related skin changes, inflammation, scars with swelling, redness, hyperthermia)
- Varicose veins with reflux disorders
- Lymphatic disorders, non-specific soft tissue swelling
- Circulatory or sensory disorders in the legs
WARNINGS AND PRECAUTIONS
- If pain, swelling, changes in sensation or other unusual reactionsoccur 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 package has been opened.
NOTE: Contact manufacturer and competent authority in case of a serious incident arising due to usage of this device.
APPLICATION INSTRUCTIONS
MALLEOFORCE & MALLEOFORCE PLUS
- Sit down to fit the MALLEOFORCE/MALLEOFORCE PLUS.
- Roll down the ankle support from the top blue border as far as the silicone pads.
- Then grip the support by the pads and pull it over your foot.
- The support is properly fitted when the heel sits firmly in place and the lateral pads are positioned behind and below the ankle.
- Pull up the upper end of the support again and straighten it over the foot and ankle.
USAGE INSTRUCTIONS
- The bandage is worn directly next to the skin. Therefore, the skin should not have any injuries and should be free of moisture, oil, grease, gels or similar residues when being put on.
- The support is intended for single patient use only.
- The support should not be worn for more than 8 hours a day.
- With proper use and the observance of all instructions, no pressure points should occur.
- The manufacturer shall bear no responsibility for any changes to the product or incorrect usage.
CARE
- Hand wash in lukewarm water (max. 30 ° C) with a mild detergent
- Air dry (do not place on radiators/heaters or other heat sources)
- Do not use bleach o chlorine, do not iron.
COMPOSITION
Knitted material: polyamide, elastin, polyester / Pad: silicone / Cover: terrycloth / Strap: polyamide, polyurethane, polyester, natural rubber, elastane, polypropylene
CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS.
FOR SINGLE PATIENT USE ONLY.
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.
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