OSSUR Formfit Knee MCL Brace Instructions

OSSUR Formfit Knee MCL Brace Instructions

INTENDED USE
The device is intended for external support or stabilization of the knee.

Indications for use
Mild to Moderate (Grade I and Grade II) Medial Collateral Ligament (MCL) sprains. No known contraindications.

GENERAL SAFETY INSTRUCTIONS
Read these instructions carefully before use. Keep them for future reference.
Any serious incident in relation to the device must be reported to the manufacturer and relevant authorities.

The device should be used directly on intact skin and never over an open wound. The patient should stop using the device and contact a healthcare professional:

• If there is a change or loss in device functionality, or if the device shows signs of
  damage or wear hindering its normal functions.

• If any pain, skin irritation, or unusual reaction occurs with the use of the device.

The device is for single patient – multiple use.

USAGE

Size Selection
Measure the thigh circumference 15 cm (6”) above mid-patella. The sizing chart is shown on the packaging, if between sizes always select the smaller size for optimal fit.

Device Application

1. Unfasten the thigh strap and wraparound. Loosen the remaining straps, but do not remove them from the D-rings.

2. With the leg in full extension, grasp the device with one hand on the side, the other on the hinge, and pull the device over the knee. Position the device, so that the opening for the kneecap and the middle of the hinge are in line with the kneecap (Fig. 2).
   

3. Wrap the thigh part around the back of the thigh and fasten the hook and loop (Fig. 3).
   

4. To prevent movement, grasp the hinge with one hand and with the other hand tighten the anterior strap (Fig. 4).
   

5.  Insert the straps through the corresponding D-ring and fasten the straps at the calf and thigh in the order shown **(Fig. 5 & 6).

**

6. Bend the knee to an 80˚ angle and tighten the DFS strap until it sits firmly against the leg **(Fig. 7 & 8).

**

7. With the knee in full extension, verify correct position and strap tension. An increase in strap tension should be felt. Re-adjust, if needed (Fig. 1).
   

Range of Motion (ROM) Adjustment

Note: Any adjustment on the device should be done by your healthcare professional.

The device comes with 0° extension pre-installed. Range of motion can be adjusted to -20˚ of extension and/or limited to 70˚ of flexion.

1. Lift away the sleeve to access the inside of the hinge.
2. Use the provided hex key to remove the screw.
3. Place the screw into the desired location and fasten. Making sure not to overtighten.

Device removal

• Unfasten the thigh strap and wraparound.
• Loosen the remaining straps, but do not remove them from the D-rings.
• Grip the device at the level of the calf and pull it off in a downward direction.

Cleaning and care

• Hand-wash using mild detergent and rinse thoroughly.
• Air dry, do not expose to direct heat.

Note: Do not machine-wash, tumble dry, iron, bleach, or wash with fabric softener. Note: Avoid contact with salt water or chlorinated water. In case of contact, rinse
with fresh water and air dry.

DISPOSAL
The device and packaging must be disposed of in accordance with respective local or national environmental regulations.

References

• Össur. Life Without Limitations.

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