DJO Codo X-Act ROM Elbow Brace User Guide

DJO Codo X-Act ROM Elbow Brace

INSTRUCTIONS

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.

INTENDED USE/INDICATIONS:
The DonJoy X-Act ROM Elbow brace is designed to provide support and immobilization to the elbow. It may be suitable for use following stable fractures. Providing immobilization or controlled movement of the limb or body segment.

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

WARNINGS AND PRECAUTIONS:

• This product is to be prescribed and fitted by a healthcare professional.
• Excessive tightening of the brace straps may compromise circulation. If tingling or numbness is experienced, loosen straps.
• Do not use over open wounds.
• Do not use this device if it is damaged and/or the packaging has been opened.
• If pain, swelling, changes in sensation or other unusual reactions occur while using this product, consult your medical professional immediately. NOTE: Contact manufacturer and competent authority in case of a serious incident arising due to usage of this device.

APPLICATION INFORMATION:

1. Unlock Hinge. The X-Act Rom Elbow is packaged in a locked position. To unlock brace, slide Red Quick-Lock button away from hinge center. (Fig.1)

2. Position Brace. Place the mid-point of hinge over lateral epicondyle (outside of elbow) Note: Red Quick Lock Button should be below Elbow when brace is applied. (Fig.2)

3. Telefit Arm Lengths. While hinged is aligned with epicondyle (mid-point of elbow) adjust position of all four cuffs. Depress the slider button and position both forearm cuffs then both bicep cuffs to desired location. Note: Make sure proximal Bicep cuff extends to most comfortable position, but does not impinge Auxila (arm pit) and distal Forarm cuff is postioned above styloid process (bump on lateral side of wrist). DO NOT attempt to remove Sliders from hinge bar. (Fig.3)

4.  Apply Brace. Unfasten the four Quick-Clip buckles on sliders by rotating the release end upward until clip is ejected off of slider. Place arm into brace. (Fig.4a) 4b. Starting with the cuffs closest to elbow, form cuffs around forearm and bicep. (Fig.4b)

5. Secure Straps. Starting at the wrist, click each of the Quick-Clip buckles onto the slider bar, making sure an “audible click” is achieved. Cinch Straps for snug fit. (Fig.5) Trim Straps as necessary. Remove aligator strap tab; trim strap; replace strap tab.
   NOTE: Bicep Strap pads are packed with brace for comfort and anti- migration.

6. Range of Motion Hinge Setting. X-Act Elbow brace allows for full range of motion in 10 degree increments from -10 to 120 degrees of flexion. To adjust settings, depress the Flexion & Extension buttons and move to prescribed range of motion (ROM). (Fig.6)

7. Quick-Lock. To prevent any range of motion, slide the red Quick-Lock button to the locked postion. X-Act Elbow brace may be locked in 0, 15, 30, 45, 60, 75, or 90 degrees of flexion. (Fig.7)

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