50K29* Ottobock OA Restore Knee Brace Practitioner Fitting Instructions

50K29 OA Restore Knee Brace Thank you for using an Ottobock product. The following information will help you fi t and care for this product. Please review it and ask for clarifi cation if needed.Indications

· Patients diagnosed with mild to moderate medial or lateral osteoarthritis (OA), as well as patients who have OA in combination with ligament instability.

· Provides support for knee instability secondary to cartilage damage or inadequate ligament support.· Provides structural corrective forces that correct and/or unload the medial or lateral aspect of knee joint.· Unicompartmental Osteoarthritis· Provide corrective forces that correct or apply control to aff ected limb

Fitting ProcessFor Medial OAStep One – Adjust the condylar pads. A large round condylar pad (two are included in the pad kit) should be placed on the inside of the LATERAL HINGE opposite the aff ected compartment (see condylar pad instructions on back cover). The thicker pad will produce more counterforce pressure and amplify the three-point correction provided by the brace.Step Two – Adjust the angulation of the thigh shell. Lift the release latch on the medial side of the brace above the aff ected compartment. Extending the brace up will re-angle the thigh shell to provide counterforce correction at the upper end of the brace. Or, as an alternative, if the patient’s leg is too short and cannot accommodate moving the medial side up, lift the release latch on the lateral side of the brace and lower the shell to increase corrective force. If the patient requires substantial correction, you can lengthen the medial side and lower the lateral side, which shift s the angle of the thigh shell as much as 18 degrees. Feedback from the patient and visual observation of the corrective pressure will help determine how much to adjust the shell angle. When the desired corrective force is achieved, push down the release latch to lock the angulation of the thigh shell. For Lateral OAStep One – Adjust the condylar pads. A large round condylar pad (two are included in the pad kit) should be placed on the inside of the MEDIAL HINGE opposite the aff ected compartment (see condylar pad instructions on back cover). The thicker pad will produce more counterforce pressure and amplify the three-point correction provided by the brace.Step Two – Adjust the angulation of the thigh shell. Lift the release latch on the lateral side of the brace above the aff ected compartment. Extending the brace up will re-angle the thigh shell to provide counterforce correction at the upper end of the brace. Or, as an alternative, if the patient’s leg is too short and cannot accommodate moving the lateral side up, lift the release latch on the medial side of the brace and lower the shell to increase corrective force. If the patient requires substantial correction, you can lengthen the lateral side and lower the medial side, which shift s the angle of the thigh shell as much as 18 degrees. Feedback from the patient and visual observation of the corrective pressure will help determine how much to adjust the shell angle. When the desired corrective force is achieved, push down the release latch to lock the angulation of the thigh shell.

Medial OA

Lift the toolless lever to release/move uprights; push down lever to lock uprights

Lateral OA

Lift the toolless lever to release/move uprights; push down lever to lock uprights

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For Ligament Instabilities Step One – Adjust the condylar pads. There are two sets of three dimensional condylar pads provided with the brace. The thinner set are mounted on the hinges at the factory. The thicker pair can be substituted to adjust the medial/lateral pressure on the sides of the knee.Step Two – Adjust the height of the thigh shell. For average height patients, leave the thigh uprights at the midpoint position set at the factory. For taller patients, over six feet, you can lift the release latch above each hinge to lengthen the brace equally on both sides. For shorter patients, you can lower the thigh shell equally on both sides to reduce the length. When the desired length is achieved, push down both latches to lock the length of the thigh shell.

Condylar Pad instructionsThe condylar pad kit that ships with the brace includes four hinge pads for adjusting the function and/or fi t of the brace. The round pads are for OA patients. One of these pads should always be installed on the inside of the hinge OPPOSITE THE DAMAGED COMPARTMENT to apply and comfortably diff use corrective pressure. The thicker round pad will apply more pressure and amplify three-point corrective forces. The kit also contains two thicker three dimensional pads. Use both of the 3D pads if you want to increased medial-lateral pressure on the sides of the knee or adjust the fi t of the brace for ligament patients. For OA patients, aft er installing a round pad on the hinge opposite the damaged compartment, you can use one of the thicker three dimensional pads on the hinge beside the damaged compartment if it enhances the overall fi t of the brace.

Extension stop instructions At the time of fabrication, zero degree extension stops have been installed in each Hinge. To install a diff erent pair of extension stops, follow these instructions:Step One: Twist off the desired pair of stops. You must install identical extension stops in both hinges.Step Two: Remove the screw located on the side of each hinge. (Fig.1)Step Three: Aft er removing the screws, fl ex the brace and remove the zero degree stop from each hinge. Note the direction each stop is facing. (Fig.2)Step Four: Insert the desired stops, hole end fi rst, with the hook end at the top and facing forward. Straighten the brace to full extension to push the stops down into position. The small hole in each stop must be aligned and visible through the screw hole so the screw will thread into the stop.5) Reinsert and tighten the screw. Flex and extend the brace several times to ensure the stop is locked into position and functioning properly.Flexion stop instructions Step One: To limit the degree of fl exion, detach the desired stops from the two enclosed metal trees. Each stop has the degree etched into the surface. You must install the same degree stop in both hinges.Step Two: If you are installing the 110 degree fl exion stops, remove the two screws from the posterior aspect of each hinge cover (Fig.1) and take out the spacer that was installed at the factory. Insert the stop, with the fl at end facing up, (Fig.2) and position it so the hole in the stop is visible through the lower screw hole in the cap. The screw must thread through the cap and stop to secure the stop in the proper position. The second (top) screw can be reinserted back into the hinge cap to fi ll the empty hole.Step Three: (Fig.3) If you are installing the 0, 30, 45, 60, 75 or 90 degree fl exion stops, remove both screws from the posterior aspect of each hinge cap (Fig.1) and take out the spacer that was installed at the factory. Insert the stop with the fl at end facing up and position it so that both holes in the stop are visible through the screw holes in the cap. Thread and tighten the screws through the cap and into both holes in the stop.Step Four: Flex the brace until the upright contacts the stops to ensure they are functioning properly.

Ligament instabilities

Short Patients Average Height Tall Patients

Condylar Pad

Two pairs of three dimensional pads are provided

One thin and one thick round pad is provided for OA patients

Extension stop

Flexion stop

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Otto Bock HealthCare LPTwo Carlson Parkway North, Suite 110Minneapolis MN, 55447P 800 328 4058 · F 800 962 2549Made in China

LiabilityThe manufacturer’s warranty applies only if the device has been used under the conditions and for the purposes described. The manufacturer recommends that the device be used and maintained according to the instructions for use. Details of the warranty are available at www.ottobockus.comManufacturer’s Limited WarrantyOtto Bock HealthCare, LP (Ottobock) warrants all of its devices, to the original purchaser, to be free from defects in materials and workmanship. This warranty applies, subject to normal wear and tear, when the devices are used as intended, without unapproved modifications, following all Ottobock instructions and requirements; and when they are fitted by or under the direct supervision of certified/licensed practitioners. This Limited Warranty does not cover device damage caused by accidents, neglect, misuse or operation beyond capacity, parts damaged by improper installation, substitution of parts not approved by Ottobock, or any alteration or repair by others that, in Ottobock’s judgment, materially or adversely affect the device.The duration of this Limited Warranty varies by product types and is effective from the date of delivery to the end-user. Please refer to www.ottobockus.com or call 800 328 4058 for questions. Ottobock’s sole obligation under this Limited Warranty shall be to repair, replace, refabricate the device at no charge, or refund the cost of the device to the original purchaser, at Ottobock’s sole discretion.THE EXPRESS WARRANTIES SET FORTH ABOVE ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTIBILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND ALL SUCH OTHER WARRANTIES ARE HEREBY DISCLAIMED AND EXCLUDED BY OTTOBOCK. IN NO EVENT SHALL OTTOBOCK’S LIABILITY OF ANY KIND INCLUDE ANY SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, EVEN IF OTTOBOCK SHALL HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH POTENTIAL LOSS OR DAMAGE.Some states do not allow the exclusion of incidental or consequential damages, thereby rendering the aforementioned limitation in applicable to certain original purchasers