DJO OA Nano 4Titude OA Nano OA Adjuster Instruction Manual

DJO OA Nano 4Titude OA Nano OA Adjuster Instruction Manual

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

INDICATIONS: The DonJoy OA Nano, 4Titude OA Nano and OA Adjuster are designed to provide support to the knee. They may be suitable for those suffering from uni-compartmental knee osteoarthritis and may help to relieve pain. Soft-good/ semi-rigid designed to restrict motion through elastic or semi-rigid construction

CONTRAINDICATIONS: Do not use if you are allergic to any of the materials contained within this product.

WARNINGS AND PRECAUTIONS:

• This product is to be prescribed and fitted by a qualified healthcare
• The frequency, duration of use and directions for use should be determined by your prescribing healthcare
• The brace should be worn directly against dry skin.
• Braces should not be worn on both left and right legs during activities that may cause the braces to contact each other resulting in potential loss of control and
• If discomfort, pain, swelling, changes in sensation or other unusual reactions occur while using this product, you should contact your doctor
• Do not use over open
• Do not use the device if it is damaged and/or the packaging has been

NOTE: Contact manufacturer and competent authority in case of a serious incident arising due to usage of this device.

APPLICATION INFORMATION:

PRE-APPLICATION (performed only at initial fitting): With the patient standing, apply the brace frame to the leg without applying the straps. Adjust the brace’s varus / valgus alignment to fit the patient’s leg contours by adjusting the screws located immediately above and below the hinge with the enclosed Allen wrench (Fig 1).

The screws will feel loose when a neutral brace position is achieved. Continue to adjust the screws to achieve the desired load.

APPLICATION:

A) While seated at the edge of a chair, flex knee to 45° and slip on brace (Fig 2).

B) Center the hinges 1 inch (2.5 cm) above the top of the knee cap and slightly behind the midline of the leg and attach straps #1 and #2 (Fig 3).

C)  Push both hinges toward the back of the leg and then attach strap #3 (Fig 4)

D) Draw the hinges forward slightly, but not beyond the midline of the leg, and attach the anti-migration band. Then attach straps #4 and #5 (Fig 5)

For OA Nano and 4Titude OA Nano, anti-migration band will need to be applied, located in accessory bag. See antimigration band application instructions.

E) T he hinges should center just above the top of the knee cap and slightly behind the midline of the leg (Fig 6).

F) Once the brace is on, perform knee bends and walk around to verify no brace slippage occurs (Fig 7).

If necessary, tighten the straps in the numbered order. The strap lengths can be adjusted beneath the strap pad (Fig 8).

STRAP PAD APPLICATION (FOR OA NANO ONLY): For additional comfort, five (5) strap pads are included in the accessory bag. These are placed internally on each strap (via Velcro attachment) to enhance overall fit and comfort.

ANTI-MIGRATION BAND APPLICATION:   The anti-migration band is used to enhance brace suspension (if needed). Separate application instructions are located in the accessory bag or the OA Nano and 4Titude OA Nano users. The anti-migration band is already attached on all OA Adjuster versions. If removed, please reference the application instructions to reapply.

HINGE STOP INSTALLATION INSTRUCTIONS : Detach both condyle pads. Insert 10° extension stops into the front of both hinges. Insert and tighten supplied screws into both hinges (Fig 9).

Re-attach both condyle pads.

CLEANING INSTRUCTIONS : Regular Cleaning of components is recommended. A dry lubricant such a TeflonTM spray may be applied to the hinge’s internal mechanism and is recommended following use in water. Inspect the hinge screws periodically and tighten if loose. To clean liners and condyle pads, hand wash in 30°C / 85°F cold water using mild soap, rinse thoroughly, and air dry. Residual soap may cause irritation and deteriorate material.

WARRANTY: DJO, LLC will repair or replace all or part of the product and its accessories for material or workmanship defects for a period of six months for softgoods and one year on brace frame/hinges from the date of sale.

MATERIAL CONTENTS:

Frame – Magnesium
Loading Mechanism – Aluminum & Steel Hinge – Aluminum & Steel
Strap tabs – Aluminum & Nylon Soft Goods – Nylon & EVA

Intended for use on a single patient. Rx ONLY

NOT MADE WITH NATURAL RUBBER LATEX.

TO ORDER A REPLACEMENT KIT, PLEASE CONTACT YOUR LOCAL DJO REPRESENTATIVE.

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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