Ossur 1545 001 Rebound Dual Knee Brace Instructions

Ossur 1545 001 Rebound Dual Knee Brace

INTENDED USE

The device is intended for external support or stabilization of the knee.
The device must be fitted and adjusted by a healthcare professional.

Indications for use

• ACL, MCL, LCL, PCL and combined instabilities.
• Conditions requiring unit compartmental load control (Accruing slider configuration).
  No known contraindications.

Warnings and Cautions:

• The use of the device may increase the risk of deep vein thrombosis and pulmonary embolism.

GENERAL SAFETY INSTRUCTIONS

The healthcare professional should inform the patient about everything in this document that is required for safe use of this device.
Any serious incident in relation to the device must be reported to the manufacturer and relevant authorities.
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.
This device is a supportive brace only and is not intended or guaranteed to prevent injury

FITTING INSTRUCTIONS

While carrying out the following instructions, please refer to the overview figure for locating components mentioned in the text (Fig. 1).

Device Application

1. Unfasten all straps on the posterior side of the device (Fig. 2).
   
   

2. Bend the knee at a 90° angle with the foot flat on the floor and place the device on the leg such that the patella is centered between the Condyle Pads (A) (Fig. 2).
   Ensure proper alignment of the device on the leg:

   • Height positioning: Align the center of the Hinge (B) slightly above the middle of the patella (Fig. 3).
     
     
     

3. The device is pre-assembled with medium Condyle Pads. There are also thin and thick Condyle Pads, as well as a hook-and-loop, shim included with the device. Use any combination of the Condyle Pads and shim to widen or narrow the width of the device at the knee.

4. The supplied tibial wedge pads can be placed between the liner and device frame to adjust the fit around the tibia. They can also be used to position the hinge center forward slightly or removed to position the hinge further back.
   Fasten the straps in the following order. All straps can be adjusted and/or trimmed to length.

5. Fit the Lower Cruciate Strap (C) first, located directly below the knee (Fig. 4). This strap is located above the calf muscle and aids in the correct positioning of the device as it helps create the device-to-bone contact required to help keep the device in place.
   

6. Next, snugly fasten the Bottom Strap (D) by inserting it through the D-Ring.

7. Continue with the Upper Cruciate Strap (E), located just above the knee and then fasten the Top Strap (F).
   Note: Overtightening the top two straps can cause the device to migrate.

8. Last, snugly fasten the Anterior Tibial Strap (G) (Fig. 5).
   
   

   • If the device frame is too far anterior, loosen the Anterior Tibial Strap and tighten the Lower and Bottom Straps.
   • If the device frame is too far posterior, loosen the Lower and Bottom Straps and tighten Anterior Tibial Strap.

Device Adjustments

Adjusting the Device Contouring

The device can be adjusted to individual anatomies. Use bending irons to cold form the aircraft-grade aluminum frame to fit different thigh and calf shapes.

How to Replace or Move the Field-Serviceable D-Rings

D-Rings can be moved from the interior to the exterior or replaced if broken.
Moving a D-Ring from the interior to the exterior:

1. Remove strap from D-Ring.

2. Bend D-Ring mounted on the device interior, push it inwards to release it from the keyhole lock and remove it from the rivet (Fig. 6).
   

3. Attach D-Ring to the device exterior by pushing down onto the rivet through the keyhole lock. Slide and click D-Ring into place. Place keyhole lock with indented side facing up (Fig. 7).
   

4. Replace strap. If needed, repeat steps for other D-Rings.

Adjusting the Height of the Device

The device can be adjusted for individual height requirements:

1. Loosen the screws on both sides of the Upper Frame (H) and pull the frame up with a steady force (Fig. 8).
   
   Ensure the device is properly aligned by checking that both hinge arms are located at the same position on the medial and lateral Hinge Arm (I).

2. Retighten the screws until snug.

Adjusting the Varus / Valgus angle of the Device

The device can be adjusted for individual Varus or valgus angles and to create an offloading force to either the medial or lateral compartment.

1. Loosen the screws on the desired side of the device and slide the Upper Frame (H) to the desired position with a steady force.
2. Adjust the medial Hinge Arm (I) to offload the medial compartment or adjust the lateral Hinge Arm to offload the lateral compartment. The slide bar has a lettered scale and may be moved to increase or decrease the amount of Varus or valgus force on the leg (Fig. 8). The lettered scale does not relate to degrees of offloading and should be used as a guide.
3. Retighten the screws until snug (recommended torque value of 3 in-lb / 0.34 Nm).
4. All adjustments should be determined by a healthcare professional, in accordance with the patient’s comfort level. Each time the device is adjusted, the healthcare professional should note the letter for a record of progression.

Range of Motion (ROM) Adjustment

The device has 0° extension stops attached to the hinges. If needed, the range of motion can be adjusted using the extension and flexion stop kits.

1. Lift and turn tab 90° ( Fig. 9).
   

2. Remove existing stop if necessary, by pulling on the lower edge of the installed stop (Fig. 10).
   

3. Insert desired flexion/extension stop with the number facing the opposite direction of leg (Fig. 11).
   

4. Return tab to initial position and press downward to lock in place ( Fig. 12).
   

5. Follow the same procedure to change any additional stops and repeat on the opposite hinge.

PCL Strap Attachment

The PCL kit is designed to counteract posterior subluxation of the tibia.
Trim and adjust the PCL strap for proper fit.
Attaching PCL Strap:

1. Note height position on medial and lateral Hinge Arms (H).
2. Remove hook-and-loop fastener to access connection area.
3. Remove Accruing Hinge Screws (J) and Cackling Hinge D-Ring.
4. Position PCL Accruing Hinge D-Ring and position PCL Accruing Hinge Inserts with raised portion into the recessed pocket.
5. Return frame to initial positions on Hinge Arms.
6. Tighten Acculign Hinge Screws and re-apply hook-and-loop fastener.
7. Attach PCL strap.

Device Removal

1. Sit down and bend the knee at an 80° angle with the foot flat on the floor.
2. Unfasten all posterior straps of the device and attach the straps back to themselves. This will make it easier to put the device on next time and will also prolong the life of the straps.

Accessories and Replacement Parts

Please refer to the Assur catalog for a list of available replacement parts or accessories.

USAGE

Cleaning and care

Washing Instructions

Washing the device with the soft goods detached allows for more thorough cleaning.

• Hand-wash using mild detergent and rinse thoroughly.
• Air dry.

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.

Hinge

• Remove foreign materials (e. g., dirt or grass) and clean using fresh water.
• Do not disassemble the hinge.

DISPOSAL

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

LIABILITY

Assur does not assume liability for the following:

• Device not maintained as instructed by the instructions for use.
• Device assembled with components from other manufacturers.
• Device used outside of recommended use condition, application, or environment.

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