DJO HB-RGB Hand Based Radial Gutter Brace User Guide

Table of Contents

DJO HB-RGB Hand Based Radial Gutter Brace User Guide

Instructions

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 user 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 Hand Based Radial Gutter Brace (HB-RGB) is designed to stabilize and immobilize the second and third metacarpals and metacarpophalangeal (MCP) joints, and the second and third digits.

PERFORMANCE CHARACTERISTICS

Providing stabilization to the limb or body segment. Providing immobilization or controlled movement to the limb or body segment

CONTRAINDICATIONSDo not use 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 brace is not too hot prior to application.
Brace should be appropriately sized to 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 brace does not fit properly, or is irritating, it may be reformed and adjusted by a healthcare professional.
Do not use device other than instructed in this IFU.
Do not modify the device without a healthcare professional present.
If patient experiences any pain, swelling, sensation changes, or any unusual reactions while using this product, consult a healthcare professional immediately.
Patient should be instructed to check for breaks and cracks and informed to see a healthcare professional for a replacement. Patient 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 brace wet.
Patient should be instructed not to expose 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.
Patient should be instructed not to expose 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 manufacturer and competent authority in case of a serious incident arising due to usage of this device.

HEATING AND APPLICATION

Proper heating temperature is 200°F (93°C).
Heat brace in Exos® recommended oven approximately 5 minutes or until brace is pliable. Brace should not be too hot to handle comfortably.
Ensure that skin is completely dry before application.
Align brace on palm so curve follows the Thenar crease. (Figure 1)
Wrap brace around hand. (Figure 2)
Secure hook-and-loop fastener straps as shown. Two straps may be used to secure the fingers, and two straps secure the wrist. (Figure 3)Note:Larger braces are packaged with slightly longer straps intended to be used to secure the wrist.
Mold brace into desired position. (Figure 4)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 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.

For fitting tips on each Exos® device:Visit the Exos® Provider Center at: http://exosmedical.com/provider/HB-RGB or Scan the QR image with your smartphone

http://exosmedical.com/provider/HB-RGB

MATERIAL USEDShell: 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

MDSS GmbHSchiffgraben 4130175 Hannover, GermanyDJO, LLC1430 Decision StreetVista, CA 92081-8553 • USA