DJO DonJoy UltraSling PRO

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Clinician Application Instructions

DonJoy

UltraSling

PRO

SIZING AND CONFIGURATION:

BEFORE USING THE DEVICE, PLEASE READ THE INSTRUCTIONS FOR USE COMPLETELY AND CAREFULLY. CORRECT APPLICATION IS VITAL TO THE PROPER FUNCTIONING OF THE DEVICE.

Arm envelope is shipped in L/XL configuration. To adjust arm envelope to the S/M size, unbuckle both

quick release buckles. Fold in arm envelope and adhere hook and loop tabs on inside of envelope.

APPLICATION:

ARM SLING SIZE MEASUREMENT

S/M 10.5”-15” (26.7cm-38.1cm)

L/XL 15+” (38.1+cm)

To ensure proper fit, if possible, product should be sized on patient pre-operatively.

Step 1. Open Arm Sling

Release quick-release buckle (i) on cushion and forearm strap (ii) on arm envelope. Unfasten

shoulder ring by releasing quick release buckles (iii) at front of arm envelope. (Fig. A)

Step 2. Apply Waist Strap

Align cushion on injured side at waist/hip level with elbow fixed at 90°. Narrow end of cushion

should be positioned to back of forearm/elbow. Bring waist strap around back and attach to

quick-release buckle (i) at front of cushion. Adjust waist belt and trim as necessary for proper fit.

(Fig. B)

Step 3. Apply Arm Sling

Place forearm into arm envelope as far back as possible. Secure thumb strap (iv) between thumb

and forefinger at front of sling. Secure forearm strap (ii) to sling and cushion. (Fig. C)

Step 4. Apply Shoulder Ring

Place arm through shoulder ring of healthy shoulder. Adjust shoulder ring circumference for

proper fit. (Fig. D) NOTE: The hook and loop closure of shoulder ring should be facing up and

away from patient.

Step 5. Fasten the Shoulder Strap

Fasten shoulder strap to arm envelope by using quick release buckles (iii).

Adjust shoulder strap for proper fit. (Fig. E)

BRACE REMOVAL:

Detach quick release buckles, remove forearm strap, thumb strap and waist belt.

Slowly remove brace.

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Summary

Sizing and Configuration Details

Clinician Application Steps

Step 1. Open Arm Sling

Release quick-release buckles to open the arm sling.

Step 2. Apply Waist Strap

Align cushion at waist/hip level and secure waist strap.

Step 3. Apply Arm Sling

Place forearm into envelope and secure thumb/forearm straps.

Step 4. Apply Shoulder Ring

Place arm through shoulder ring and adjust circumference.

Step 5. Fasten the Shoulder Strap

Fasten shoulder strap to arm envelope and adjust fit.

Conversion to Left Shoulder Support

Intended Use and Warnings

Intended User Profile

User should be able to read and understand directions, warnings, and cautions.

Intended Use;Indications

For post-operative rotator cuff repairs, Bankart procedures, capsular shifts, etc.

Warnings and Cautions

Consult medical professional for pain, swelling, or unusual reactions.

Cleaning and Maintenance

Cleaning & Storage Instructions

Hand wash in mild soap and water (30°C), air dry. Avoid ironing, tumble drying, bleaching.

Material and Warranty Information

Material Contents

Lists materials like Nylon, Polyurethane Foam, Cotton, Polyester.

Warranty Details

DJO, LLC will repair or replace defective units for six months from sale.

Single Patient Use

Product is intended for single patient use only.

Latex Information

Product is not made with natural rubber latex.

The DonJoy UltraSling PRO is a medical device designed for post-operative support and immobilization of the arm and shoulder, particularly for conditions such as rotator cuff repairs, Bankart procedures, capsular shifts, glenohumeral dislocation/subluxation, and soft tissue strains/repairs. It is intended for single patient use and is not made with natural rubber latex.

Function Description:

The UltraSling PRO provides immobilization and support for the injured arm and shoulder, maintaining the elbow at a 90-degree fixed angle. It features an arm envelope, a cushion, a waist strap, and a shoulder ring to secure the arm in the desired position. The design allows for adjustment to accommodate different arm and waist sizes and can be configured for either a right or left arm injury. An optional cushion allows for use with or without the cushion, depending on the patient's needs and the prescribed treatment.

Important Technical Specifications:

Arm Sling Sizing:
- S/M: 10.5"-15" (26.7cm-38.1cm)
- L/XL: 15+" (38.1+cm)
Waist Belt Sizing: Fits waist sizes 25"-63" (63.5cm-160cm). The waist belt can be adjusted and trimmed for proper fit.
Materials: Nylon, Polypropylene, Polyurethane Foam, Cotton, Laminate Foam/Tricot, Polyacetal, Polyester, Acetal. These materials are chosen for durability, comfort, and ease of maintenance.

Usage Features:

The UltraSling PRO is designed for ease of application and adjustment, ideally sized on the patient pre-operatively.

Sizing and Configuration:
- The arm envelope is shipped in an L/XL configuration. To adjust to S/M, quick-release buckles are unbuckled, the arm envelope is folded in, and hook and loop tabs on the inside are adhered.
- The device is shipped in a right arm injury configuration. To convert to a left arm injury configuration:
  1. Release quick-release buckles at the front of the arm envelope.
  2. Detach the cushion from the arm envelope.
  3. Apply the cushion to the left side of the body, flipping it over so the smaller end points to the back of the left elbow.
  4. Wrap the waist belt around the waist and attach the arm envelope to the cushion.
  5. Slip the shoulder ring over the right shoulder.
  6. Place the arm in the sling and reattach quick-release buckles.
Application Steps:
1. Open Arm Sling: Release quick-release buckle (i) on the cushion and forearm strap (ii) on the arm envelope. Unfasten the shoulder ring by releasing quick-release buckles (iii) at the front of the arm envelope.
2. Apply Waist Strap: Align the cushion on the injured side at waist/hip level with the elbow fixed at 90°. The narrow end of the cushion should be positioned to the back of the forearm/elbow. Bring the waist strap around the back and attach it to quick-release buckle (i) at the front of the cushion. Adjust the waist belt and trim as necessary.
3. Apply Arm Sling: Place the forearm into the arm envelope as far back as possible. Secure the thumb strap (iv) between the thumb and forefinger at the front of the sling. Secure the forearm strap (ii) to the sling and cushion.
4. Apply Shoulder Ring: Place the arm through the shoulder ring of the healthy shoulder. Adjust the shoulder ring circumference for proper fit. The hook and loop closure of the shoulder ring should face up and away from the patient.
5. Fasten the Shoulder Strap: Fasten the shoulder strap to the arm envelope using quick-release buckles (iii). Adjust the shoulder strap for proper fit.
Brace Removal: Detach quick-release buckles, remove the forearm strap, thumb strap, and waist belt. Slowly remove the brace.
Optional Cushion Use: The UltraSling PRO can be worn without the cushion. To do so, remove the back of the waist belt from the cushion and adhere the y-strap to both sides of the arm sling envelope at the elbow. For the front of the waist belt, remove the quick-release buckle from the cushion and adhere the y-strap to the arm sling envelope. Trim the waist belt as needed.
Warnings and Cautions: Users should consult a medical professional immediately if they experience any pain, swelling, sensation changes, or unusual reactions while using the product.

Maintenance Features:

Cleaning Instructions: Hand wash in water (86°F/30°C) using mild soap. Air dry.
Important Cleaning Notes:
- If not rinsed thoroughly, residual soap may cause irritation and deteriorate the material.
- Do NOT iron.
- Do NOT tumble dry.
- Do NOT bleach.

Warranty:

DJO, LLC provides a warranty for material or workmanship defects for a period of six months from the date of sale. This warranty applies to all or part of the unit and its accessories. In cases where local regulations conflict with the warranty terms, the local regulations will take precedence.