DONJOY ULTRASLING IV ER User Guide

DONJOY ULTRASLING IV ER

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 user should be able to:

• Read and understand the directions, warnings and cautions.

INTENDED USE / INDICATIONS: For protocols involving immobilization in external rotation • Glenohumeral dislocation/subluxation • Capsular Shifts • Use after posterior shoulder stabilizations

• Post-operative Bankart procedures
• Post-operative positioning after the release of severe anterior capsule contracture
• Soft tissue strains/repairs

PERFORMANCE CHARACTERISTICS: Providing immobilization or controlled movement of the limb or body segment.

CONTRAINDICATIONS: None.

WARNINGS AND PRECAUTIONS:

• Do not use over open wounds.
• If pain, swelling, changes in sensation or other unusual reactions occur while using this product, you should contact your doctor immediately.
• Do not use the device if it is damaged.
  NOTE: Contact the manufacturer and the competent authority in case of a serious incident arising due to usage of this device.

APPLICATION INFORMATION

To ensure proper fit, the product should be sized on the patient pre- operatively. The product is shipped with strapping and sling configured to address post-op or rehab for a right shoulder/arm. The symbol for Right (R) on the cushion should be facing up. To convert for left shoulder/arm, detach sling from abductor cushion; flip the cushion over so waist buckle is to front and the Left (L) symbol is facing up; attach sling to outside of cushion with Velcro strips.

1. The release waist belt on the cushion, Velcro strips at wrist position on the front of the sling, and forearm strap (fig. A).

2.  Align cushion on the injured side at waist/hip level with elbow fixed at 90°. Place the cushion so the line on top of the cushion is parallel to the front of your body (if you stand at a table, the line should be parallel to the table).

3. Bring waist strap from cushion around the back of the waist and secure buckle at front of the pillow (fig. B). Adjust waist strap and trim as necessary for proper fit.

4. Place the forearm into the sling with an arm as far back as possible in the sling (fig C). Secure Velcro straps at the wrist position by first anchoring the strap closest to the cushion, on the cushion. Feed outside Velcro strap through inside D-ring and secure strap on the outside of sling (fig. D). Place small mesh thumb strap

5. between thumb and forefinger and secure on the sling. Secure forearm strap

6. to sling and cushion (fig. E).

7. Using your free arm reach behind your body and slip your arm through the shoulder strap (fig. F). This motion is similar to putting on a backpack. One strap should be over the unaffected shoulder (clavicular area) and the other under the arm (straps B & C). Secure end of clip-on Strap A to mate at front of cushion (fig. G). Adjust and trim all straps for proper fit by removing Y-tab on end of straps, trim to the proper length, and replace Y-tab.
   FOR O.R. APPLICATION
   Complete application steps 1 – 4 followed by: Unfasten one end of the auxiliary (underarm) strap. This strap is strap C for right arm or strap B for left arm. Bring shoulder strap (strap A) over and around the neck area and bring axilla (underarm) strap under arm and feed through flat O-ring. Secure strap with Velcro tab.

8. Adjust ALL straps for adequate stabilization of the injured shoulder. Remove
   Y- tabs on strap ends and trim as needed. Replace Y-tabs and secure straps.

9. For exercise and rehab detach the outside Velcro strap at the wrist area to increase the range of motion.

NOTE: Large, flat O-rings on the front (Pectoral/Clavicle) and back (Scapula) should be positioned for maximum patient comfort.

STEP DOWN OPTION FOR REHAB

To use the UltraSling IV ER without the Abductor Cushion, remove the waist strap from the Cushion, and thread waist strap through small D-rings located on front and back of sling. A secure strap around the waist with Velcro tabs. Trim as needed.

CLEANING INSTRUCTIONS

Hand washes in cold water 30°C/85°F. Hang dry.

MATERIAL CONTENTS

Nylon, Polyester, Spandex, Polyurethane.

WARRANTY: DJO, LLC will repair or replace all or part of the unit and its accessories for material or workmanship defects for a period of six months from the date of sale. To the extent the terms of this warranty are inconsistent with local regulations, the provisions of such local regulations will apply.

Rx ONLY.
FOR SINGLE-PATIENT USE ONLY

NOT MADE WITH NATURAL RUBBER LATEX.

NOTICE: WHILE EVERY EFFORT HAS BEEN MADE IN STATE-OF-THE-ART TECHNIQUES TO OBTAIN THE MAXIMUM COMPATIBILITY OF FUNCTION, STRENGTH, DURABILITY AND COMFORT, THERE IS NO GUARANTEE THAT INJURY WILL BE PREVENTED THROUGH THE USE OF THIS PRODUCT.

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