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® DEROYAL SHOULDER DEROYAL® SHOULDER P.A.D. IV ABDUCTION P.A.D. IV ABDUCTION DEVICE DEVICE SINGLE PATIENT USE SINGLE PATIENT USE NON-STERILE INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE NON-STERILE NOT MADE WITH NATURAL RUBBER LATEX CONFIGURATION CONFIGURATION 1. Abduction device is initially configured NOT MADE WITH NATURAL RUBBER LATEX 1. Abduction device is initially configured RX ONLY FEDERAL U.S.A. LAW RESTRICTS THIS DEVICE to fit the patient’s right shoulder. To to fit the patient’s right shoulder. To TO SALE OR USE BY OR ON THE ORDER configure for the left shoulder, release 1 RX ONLY FEDERAL U.S.A. LAW RESTRICTS THIS DEVICE configure for the left shoulder, release 1 OF A PHYSICIAN OR PROPERLY LICENSED the waist strap from the front (black) TO SALE OR USE BY OR ON THE ORDER PRACTITIONER. the waist strap from the front (black) buckle clasp on the P.A.D. (Positioned OF A PHYSICIAN OR PROPERLY LICENSED buckle clasp on the P.A.D. (Positioned PRACTITIONER. Abduction Device). Remove the P.A.D. Abduction Device). Remove the P.A.D. by releasing the flap from the sling via IMPORTANT INFORMATION by releasing the flap from the sling the hook strip at the top of the P.A.D. 2 via the hook strip at the top of the 2 Please read all instructions, warnings and cautions before and sling (Picture 1). IMPORTANT INFORMATION use. Correct application is essential for proper functioning P.A.D. and sling (Picture 1). 2. Roll the P.A.D. away from the sling and Please read all instructions, warnings and cautions before of the product. Use only on the person it was provided to by a use. Correct application is essential for proper functioning 2. Roll the P.A.D. away from the sling remove the P.A.D. from the hook strip and remove the P.A.D. from the hook healthcare professional and only for the use it was intended. (Picture 2). of the product. Use only on the person it was provided to by a healthcare professional and only for the use it was intended. strip (Picture 2). 3. Flip the sling over for left side 3. Flip the sling over for left side INTENDED USE configuration and ensure the pad flap 3A 3A The DeRoyal® Shoulder P.A.D. IV is for surgical rotator cuff INTENDED USE configuration and ensure the pad flap is fully extended out from the bottom ® is fully extended out from the bottom repairs, anterior glenohumeral capsular reconstruction, of the sling. The DeRoyal Shoulder P.A.D. IV is for surgical rotator cuff dislocation/subluxation of G-H joint, S/P glenohumeral of the sling. 4. With the inside curve of the P.A.D. repairs, anterior glenohumeral capsular reconstruction, acromioplasty, Bankart repairs, soft tissue repairs, and shoulder dislocation/subluxation of G-H joint, S/P glenohumeral 4. With the inside curve of the P.A.D. facing upward and the flat side on the facing upward and the flat side on the sprains/strains. table, attach the flap to the center top acromioplasty, Bankart repairs, soft tissue repairs, and shoulder 3B sprains/strains. table, attach the flap to the center top 3B edge of the P.A.D. (back side). NOTE: edge of the P.A.D. (back side). NOTE: side closest to sling via the hook strip on the P.A.D. flap side closest to sling via the hook strip on the P.A.D. CAUTIONS (Picture 3A). Roll the P.A.D. toward the sling and attach the • A physician or properly licensed practitioner (a “prescriber”) CAUTIONS flap (Picture 3A). Roll the P.A.D. toward the sling and exposed side of the hook strip on the flap to the loop on attach the exposed side of the hook who is familiar with the use and purpose of this brace must the sling (Picture 3B). Ensure there is • A physician or properly licensed practitioner (a “prescriber”) fit it to the user. The prescriber has a duty to provide wearing who is familiar with the use and purpose of this brace must strip on the flap to the loop on the no exposed hook material between the sling (Picture 3B). Ensure there is no instructions and risks related to the use of this brace to other P.A.D. and sling. fit it to the user. The prescriber has a duty to provide wearing healthcare practitioners treating the users and the users instructions and risks related to the use of this brace to other exposed hook material between the themselves, including duration of use. The instructions provided P.A.D. and sling. APPLICATION 4A healthcare practitioners treating the users and the users 4A in this sheet do not supersede hospital protocol or direct orders themselves, including duration of use. The instructions provided 1. Release the shoulder strap from the APPLICATION of the prescriber. front (gray) buckle clasp where the in this sheet do not supersede hospital protocol or direct orders • Use only as directed by medical professional. of the prescriber. 1. Release the shoulder strap from the D-ring attaches to the front cuff of the front (gray) buckle clasp where the • Prolonged usage can result in muscle atrophy in the user. sling (Picture 4A). Release the waist • Use only as directed by medical professional. The user may require (1) a weaning period from the brace to • Prolonged usage can result in muscle atrophy in the user. D-ring attaches to the front cuff of the strap from the front (black) buckle sling (Picture 4A). Release the waist build muscle strength (2) regular physical therapy exercises clasp on the P.A.D. (Picture 4B). 4B The user may require (1) a weaning period from the brace to 4B to maintain the strength of the shoulder (3) a limitation on build muscle strength (2) regular physical therapy exercises strap from the front (black) buckle 2. Release the forearm strap to clasp on the P.A.D. (Picture 4B). duration of use or (4) some combination of these. completely open the sling. to maintain the strength of the shoulder (3) a limitation on • Inspect brace for damaged or missing components before use. duration of use or (4) some combination of these. 2. Release the forearm strap to 3. Align the P.A.D. around the patient’s completely open the sling. • Discontinue use and consult your prescriber if the brace or its waistline on the affected side (Picture • Inspect brace for damaged or missing components before use. components break or become damaged. • Discontinue use and consult your prescriber if the brace or its 3. Align the P.A.D. around the patient’s 5a). Place affected arm in the sling 5A waistline on the affected side (Picture 5A • Inspect the fit of the brace on the patient to ensure fit is proper. and place the patients hand under the components break or become damaged. DO NOT OVERTIGHTEN. Check regularly to ensure circulation is • Inspect the fit of the brace on the patient to ensure fit is proper. 5a). Place affected arm in the sling thumb strap so it rests comfortably and place the patients hand under the not compromised. in the fold of the sling (Picture 5B). DO NOT OVERTIGHTEN. Check regularly to ensure circulation is • Consult your prescriber immediately if you experience sensation not compromised. thumb strap so it rests comfortably NOTE: Ensure all open wounds are in the fold of the sling (Picture 5B). changes, unusual reactions, swelling or increased pain while covered before applying device. • Consult your prescriber immediately if you experience sensation using this brace. Discontinue use if pressure injuries develop. 5B changes, unusual reactions, swelling or increased pain while NOTE: Ensure all open wounds are 5B 4. Ensure patient’s elbow is positioned covered before applying device. • Wear clothing underneath this brace. as far back in the sling as possible using this brace. Discontinue use if pressure injuries develop. • Take special care if the user is diabetic or has poor circulation • Wear clothing underneath this brace. 4. Ensure patient’s elbow is positioned for best fit and comfort (Picture 6). as far back in the sling as possible as these users may have decreased skin sensitivity and are at Tighten the thumb strap, if needed, so • Take special care if the user is diabetic or has poor circulation greater risk for poor peripheral circulation and pressure injuries. as these users may have decreased skin sensitivity and are at for best fit and comfort (Picture 6). the patient’s thumb rests comfortably. Tighten the thumb strap, if needed, so 6 greater risk for poor peripheral circulation and pressure injuries. 6 the patient’s thumb rests comfortably. 5. To adjust the sling length, roll the cuff CLEANING INSTRUCTIONS 5. To adjust the sling length, roll the CLEANING INSTRUCTIONS at the front of the sling until the sling Hand wash with mild detergent in lukewarm water. Air dry prior cuff at the front of the sling until the Hand wash with mild detergent in lukewarm water. Air dry prior is aligned with the first joint of the to wearing. sling is aligned with the first joint of to wearing. patient’s pinky finger (Picture 7). the patient’s pinky finger (Picture 7). 6. Reattach the forearm strap to close 7 STORAGE AND TRANSPORT CONDITIONS 6. Reattach the forearm strap to close 7 STORAGE AND TRANSPORT CONDITIONS and secure the sling. and secure the sling. KEEP DRY KEEP DRY 7. Bring the shoulder strap across the 7. Bring the shoulder strap across the patient’s back and place the non- KEEP AWAY FROM SUNLIGHT patient’s back and place the non- KEEP AWAY FROM SUNLIGHT affected arm through the strap that affected arm through the strap that is in the shape of a circle (Picture 8A is in the shape of a circle (Picture 8A 8A), making sure one cushion is WARRANTY 8A), making sure one cushion is WARRANTY positioned on top of the shoulder and DeRoyal® products are warranted for ninety (90) days from positioned on top of the shoulder DeRoyal® products are warranted for ninety (90) days from one cushion is positioned under the the date of shipment from DeRoyal as to product quality and and one cushion is positioned the date of shipment from DeRoyal as to product quality and arm (Picture 8B).

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