ROTEN Shouldfix II Shoulder and Arm Brace Instruction Manual

1. Product Overview

The ROTEN Shouldfix II is a practical and reliable medical device designed for excellent immobilization of the shoulder joint. It is composed of an arm cuff, two shoulder straps, a retention band, and an exclusive elbow collar. These four components, made from hook-and-loop fabric, allow for optimal adjustment to achieve the correct arm and shoulder position, maintaining it day and night. The elbow collar specifically prevents the arm from slipping outwards, even during extended use or sleep. This brace is easy to apply and remove, and is radiotransparent.

2. Indications for Use

The ROTEN Shouldfix II shoulder and arm brace is indicated for:

• Compound fractures of the humerus
• Glenohumeral dislocations
• Shoulder sprains
• Post-operative treatment for humeral fractures and glenohumeral dislocation surgeries
• Post-operative treatment for tenorrhaphies of the long head of the biceps brachii

3. Components

The ROTEN Shouldfix II brace consists of the following main components:

• Arm Cuff: Made of hook-and-loop fabric for maximum adjustability.
• Shoulder Straps: Two soft hook-and-loop straps that cross over the back.
• Elbow Collar: An exclusive collar made of reticular fabric designed to secure the elbow and prevent arm slippage.
• Retention Band: A hook-and-loop fabric band for additional adjustment and securement around the torso.

4. Setup and Application

Follow these steps for proper application of the ROTEN Shouldfix II brace:

1. Prepare the Brace: Ensure all straps and the arm cuff are unfastened and ready for adjustment.
2. Position the Arm Cuff: Place the arm cuff around the forearm and elbow of the affected arm. The elbow should fit comfortably into the designated elbow collar.
3. Secure the Arm Cuff: Fasten the arm cuff securely but comfortably around the forearm using the hook-and-loop closures.
4. Attach Shoulder Straps: Bring the two shoulder straps over the shoulders and cross them behind the back.
5. Fasten Shoulder Straps: Bring the ends of the shoulder straps forward and attach them to the arm cuff or designated fastening points on the brace. Adjust for a snug, supportive fit without causing excessive pressure on the neck or shoulders.
6. Apply Retention Band: Wrap the retention band around the torso, over the affected arm and the arm cuff. Fasten it securely to provide additional immobilization and prevent external rotation of the arm.
7. Final Adjustments: Ensure the arm is held in the correct, immobilized position. The brace should feel supportive and comfortable, allowing for necessary blood circulation. Adjust all straps as needed for optimal fit and comfort.

5. Operating Instructions (Wearing the Brace)

Once properly fitted, the ROTEN Shouldfix II brace is designed to maintain the arm and shoulder in a stable, immobilized position. It can be worn day and night as prescribed by a medical professional.

• Comfort and Fit: Regularly check that the brace remains comfortable and does not cause any skin irritation, numbness, or excessive pressure. Adjust straps if necessary.
• Movement Restrictions: Avoid movements that counteract the brace's immobilization purpose. Follow your healthcare provider's specific instructions regarding arm and shoulder movement.
• Removal: The brace is designed for easy application and removal. To remove, unfasten the retention band first, then the shoulder straps, and finally the arm cuff.

6. Maintenance

Proper care and maintenance will extend the life of your ROTEN Shouldfix II brace:

• Cleaning: Hand wash the brace with mild soap and cold water. Do not use bleach or harsh detergents.
• Drying: Air dry the brace completely. Do not tumble dry, iron, or expose to direct heat, as this can damage the fabric and hook-and-loop fasteners.
• Storage: Store the brace in a clean, dry place away from direct sunlight when not in use.
• Inspection: Periodically inspect the brace for any signs of wear, tear, or damage to the fabric or fasteners. Discontinue use if significant damage is observed and consult your healthcare provider or supplier.

7. Troubleshooting

If you encounter any issues while using the ROTEN Shouldfix II brace, consider the following:

• Discomfort or Pain: If the brace causes discomfort, pain, numbness, or tingling, immediately loosen the straps and readjust. Ensure no straps are too tight. If discomfort persists, consult your healthcare provider.
• Brace Slippage: If the brace slides or does not maintain the arm's position, re-evaluate the strap adjustments. Ensure all hook-and-loop fasteners are securely engaged and the retention band is snug around the torso.
• Skin Irritation: If skin irritation occurs, ensure the brace is clean and dry. Consider wearing a thin, breathable layer of clothing underneath the brace. If irritation persists, consult your healthcare provider.
• Damage to Brace: If any part of the brace is damaged, do not attempt to repair it yourself. Contact your supplier or healthcare provider for guidance.

8. Specifications

9. Warranty and Support

Specific warranty information for the ROTEN Shouldfix II brace is not provided in this manual. For details regarding warranty coverage, returns, or technical support, please contact your point of purchase or the manufacturer, RO+TEN, directly. Always consult with a healthcare professional for medical advice regarding the use of this device.