Össur REBOUND POST-OP ELBOW Instrucciones Para El Uso página 5

ENGLISH
Medical Device
INTENDED USE
The device is intended to provide controlled range-of-motion for post-
traumatic, post-surgical repair of the elbow
The device must be fitted and adjusted by a healthcare professional.
Indications for use
Indications requiring elbow immobilization and/or range of motion
restriction. This may include:
• Stable fractures of the elbow, distal humerus, proximal radius, or ulna
• Tendon and ligament injuries or repairs
• Collateral ligament reconstructions
• Elbow hyperextension
• Triceps tendon repair
• Chronic elbow injuries
• Tennis elbow release
No known contraindications.
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 immediately 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.
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 buckles and straps of the device.
2. Locate the hinge pivot center over the lateral humeral epicondyle
(outer elbow) (Fig. 2).
3. Device length should be adjusted to provide optimal elbow
stabilization. To adjust the position of the Cuffs:
– Push down the length adjustment button to unlock and slide
telescoping paddle until desired length is achieved (Fig. 3).
Positioning Guidelines:
– Forearm Cuff (A) extension should extend up to the styloid process
(bump on the medial side of wrist), avoid impinging on the styloid
process.
– Upper Arm Cuff (B) should extend up to the most comfortable
position, avoid impinging the axilla (armpit).
– Adjust the Inner Cuffs (C) if needed.
Note: Ensure all length adjustment buttons are in locked position.
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