DJO 10030-001 Wrist Brace User Guide

: June 3, 2024
: DJO

Table of Contents

**WRIST BRACE
INTENDED USER PROFILE
INTENDED USE / INDICATIONS
CONTRAINDICATIONS
OPERATING LACING SYSTEM
HEATING AND APPLICATION
CLEANING INSTRUCTIONS
LIMITED PRODUCT WARRANTY
Documents / Resources

10030-001 Wrist Brace
INSTRUCTIONS

**WRIST BRACE

**

antimicrobial treated

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Before using the device, please read the entire instruction manual.
Correct application and care is vital to the proper functioning of the device.

INTENDED USER PROFILE

The intended use should be a licensed medical professional, the patient, or the patient’s caregiver. The user should be able to read, understand and be physically capable of performing the directions, warnings, and cautions in the information for use.

INTENDED USE / INDICATIONS

The Wrist Brace (WB) is designed to stabilize and immobilize the wrist joint.
PERFORMANCE CHARACTERISTICS
Providing stabilization to the limb or body segment.
Providing immobilization or controlled movement to the limb or body segment.

CONTRAINDICATIONS

Do not use it if you are allergic to any of the materials contained within this product.
WARNINGS AND PRECAUTIONS

This product must be prescribed and fitted by a healthcare professional. The frequency and duration of use should be determined by your healthcare professional. • Do not heat brace on the body.
Check to make sure the brace is not too hot prior to application.
The brace should be appropriately sized for the patient to ensure proper function.
Wearing Care should be taken with patients with delicate or compromised skin, especially the elderly, not to apply the brace too tightly, which MAY cause pressure and shear to the fragile tissue. PATIENTS SHOULD BE INSTRUCTED ON APPROPRIATE TENSIONING DURING ONGOING USE. An under-sleeve or STOCKINETTE may be used for added protection.
Do not heat Exos® products to greater than 212°F (100°C).
If the brace does not fit properly or is irritating, it may be reformed and adjusted by a healthcare professional.
Do not use devices other than those instructed in this IFU.
Do not modify the device without a healthcare professional present.
If the patient experiences any pain, swelling, sensation changes, or any unusual reactions while using this product, consult a healthcare professional immediately.
Patients should be instructed to check for breaks and cracks and informed to see a healthcare professional for a replacement. Patients should be instructed on proper cleaning and drying instructions (see Patient Cleaning Instructions below).
If the brace is applied with a Locking Ring, the patient must not get the brace wet.
Patients should be instructed not to expose the brace to heat over 130°F (55°C) as the brace may soften and lose its desired shape.
Keep out of reach of children under three years of age to avoid accidental ingestion of the small parts.
Patients should be instructed not to expose the brace to moisturizers, chemicals, or solvents, as they may affect durability.
Do not use over open wounds.
Do not use the device if it is damaged and/or the packaging has been opened.

NOTE: Contact the manufacturer and the competent authority in case of a serious incident arising due to the usage of this device.

OPERATING LACING SYSTEM

To Loosen:

Lift the hook-and-loop fastener tab.
Pull open the brace. (Figure 1)

To Close and Tighten:

Pull the hook-and-loop fastener tab to cinch the lace. (Figure 2)
Wrap excess lace around the brace.
Secure hook-and-loop fastener tab to brace.

HEATING AND APPLICATION

Open and unfold brace. (Figure 3)
The proper heating temperature is 200°F (93°C).
Heat the brace in Exos® recommended oven for approximately 3-4 minutes or until the brace is pliable.
The brace should not be too hot to handle comfortably.
Ensure that skin is completely dry before application.
Fit brace on the patient. (Figure 4)
Caution: Do not tighten the brace fully until the brace has returned to room temperature otherwise indentations in plastic may occur.
Remove the slack in the lace and attach the fastener tab to the brace.
Mold brace into the desired position. (Figure 5)
Hook-and-loop fastener strap may be secured in the desired position.
Once the brace has hardened, the lace may be tightened to desired tension.
Warning: The brace should not be worn too tightly. This may produce excessive mechanical force or shear forces to the skin.

CLEANING INSTRUCTIONS

Loosen or remove the brace.
Wash inside and outside of the brace and skin with antibacterial soap and water (86°F / 30°C).
Rinse thoroughly with water.
Use a hair dryer set on high volume and cool setting to thoroughly dry the interior of the brace, and skin.
Retighten the brace.

http://exosmedical.com/provider/WB

For fitting tips on each Exos® device:
Visit the Exos® Provider Center at:
http://exosmedical.com/provider/WB or Scan the QR image with your smartphone.
MATERIAL USED
Shell: EVA foam, spandex, nylon, terpolymer, polyester Antimicrobial treatment FOR SINGLE PATIENT USE ONLY.
Rx ONLY.

LIMITED PRODUCT WARRANTY

DJO, LLC will repair and replace all or part of the unit and its accessories for material or workmanship defects for a period of 8 weeks 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.

10030-001 REV M – 2021-02-26
USA and International Patents Pending MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
DJO, LLC
1430 Decision Street
Vista, CA 92081-8553 USA