English - DJO DONJOY X-ACT ROM ELBOW Manual De Instrucciones

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ENGLISH

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.
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PERFORMANCE CHARACTERISTICS: 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.
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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)
4a. 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)
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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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