DonJoy OA FullForce Knee Brace

Intended User Profile

The intended user should be a licensed medical professional, the patient, or the patient’s caregiver. The user should be able to read, understand, and be physically capable of performing the directions, warnings, and cautions provided in the information for use.

Indications

The DonJoy OA FullForce Knee Brace is designed to provide support to the knee. It may be suitable for individuals suffering from uni-compartmental knee osteoarthritis. The brace is a soft-good/semi-rigid design intended to restrict motion through its construction.

Contraindications

None

Application Instructions

1. While sitting on the edge of a chair, step through the brace. Flexing the knee to 45°, position the brace as shown in Figure 1, centering the hinge about 1” (2.54 cm) above the top of the kneecap and slightly past the midline of the leg. Ensure the brace is not twisted on the leg. Secure the bottom calf strap first (A), then the top thigh strap (B).
2. Keeping the knee bent at 45 degrees, push both condyles (hinges) toward the back of the leg, as shown in Figure 2. To maintain the position of the hinges, secure the lower thigh strap (C) on the back of the leg.
3. Draw the hinges forward slightly before fastening the front tibial (shin) strap (D). Do not pull the hinges beyond the midline of the leg. Secure the upper calf strap (E). Be careful not to pull this strap too tight and risk circulation problems.
4. When all strapping is complete, the hinge should center just above the top of the kneecap and slightly behind the midline. To ensure that no slippage occurs during activity, it is recommended to do a few knee bends or walk for a few minutes, then re-tighten the straps.

Figure 1 Description: Illustrates the initial positioning of the brace on the leg, showing the hinge placement relative to the kneecap and midline, and the first straps (A, B) to be secured.

Figure 2 Description: Depicts pushing the condyles (hinges) towards the back of the leg and securing the lower thigh strap (C) to maintain hinge alignment.

Instructions for Adjustable Loading Hinge

Your brace frame has a base corrective load built into it. You can "fine-tune" your base load by turning the adjustment screws clockwise using the enclosed Allen wrench. Adjust the front and back screws based on their interface with the knee and comfort. Do not turn any single screw more than 4 revolutions without toggling to the other adjustable screw. Avoid binding the adjustment mechanism. Do not exceed 10 full revolutions, as the pad may become dislodged; if this occurs, reverse the process. Always load the brace according to your comfort and activity level.

Note: Immediate relief is not always indicative of the brace's effectiveness. Soft tissue in the knee may take several weeks to adjust to the increased load.

Instructions for Changeable Stops

Standard Hinge

Your brace comes with 10° extension stops installed. To change the installed stops:

• Completely remove the screw as shown in Figure 5.
• Remove the existing stops.
• Insert the new stops, aligning them with the holes in the hinge plate.
• Reinsert the screw and tighten completely using a Phillips head screwdriver, ensuring it is seated in the recess.

Adjustable Hinge

To change stops on the adjustable loading hinge:

• First, remove the adjustable loading condyle from the hinge by toggling back and forth and turning the screws clockwise until the pad is removed.
• Remove the old stop and insert the new stop.
• To replace the telescoping pad, align the screws with the holes of the hinge plate.
• Hold the pad firmly and use the Allen wrench to turn counterclockwise until the threads engage.
• Toggle back and forth between screws until the pad is returned to its original position (as shown in Figure 6).

Both medial and lateral stops must be identical in degree.

Extension Stops: 0°, 10°, 20°, 30°, and 40°.

Flexion Stops: 0°, 45°, 60°, 75°, and 90° (no flexion stops are installed upon shipment).

Figure 5 Description: Illustrates the process of removing a screw to change stops on a standard hinge.

Figure 6 Description: Depicts removing the adjustable loading condyle and reinserting the telescoping pad for an adjustable hinge.

Use and Care

• If re-tightening is necessary during activity, re-tighten all straps following the application instructions.
• All straps and pads may be trimmed to fit individual variations in limb circumference.
• The brace may be used in fresh or salt water. After use in water activities, drain thoroughly, rinse with clean, fresh water, and then air dry.
• Hand wash liners and condyle pads in cold water with mild detergent. AIR DRY ONLY; DO NOT HEAT DRY LINERS OR PADS.
• The hinge mechanism requires minimal maintenance in normal use. A dry lubricant, such as Teflon™ spray, may be applied to the internal mechanism of the hinge. Dry lubrication is recommended after use in water.
• Periodically inspect hinge screws for tightness and retighten as needed.

Warnings and Precautions

• This product must be prescribed and fitted by a qualified healthcare professional.
• The frequency, duration of use, and directions for use should be determined by your prescribing healthcare professional.
• ROM (Range of Motion) settings should not be changed without supervision of a medical professional.
• If discomfort, pain, swelling, changes in sensation, or other unusual reactions occur while using this product, contact your doctor immediately.
• If you develop an allergic reaction and/or experience itchy, red skin after contact with any part of this device, stop using it and contact your healthcare professional immediately.
• Do not use over open wounds.
• Do not use the device if it is damaged and/or the packaging has been opened.

Note: Contact the manufacturer and competent authority in case of a serious incident arising from the usage of this device.

Latex Statement

NOT MADE WITH NATURAL RUBBER LATEX.

Disclaimer

While every effort has been made using state-of-the-art techniques to obtain maximum compatibility of function, strength, durability, and comfort, there is no guarantee that injury will be prevented through the use of this product.

Warranty

DJO, LLC will repair or replace all or part of the product and its accessories for defects in material or workmanship for a period of six months from the date of sale.