DJO Global Long Thumb Spica II with Boa Instruction Manual

DJO Global Long Thumb Spica II with Boa

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, the patient’s caretaker, or a family member providing assistance. The user should be able to read, understand and be physically capable to perform all the directions, warnings and cautions provided in the information for use.
INTENDED USE / INDICATIONS: The Long Thumb Spica II (LTS II) is designed to stabilize and immobilize the thumb in abduction, metacarpophalangeal (MCP) joint, carpometacarpal (CMC) joints, distal radius and distal ulna. The LTS II may be suitable for those suffering from Carpal Tunnel Syndrome (CTS).
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 if you are allergic to any of the materials contained within this product.

WARNINGS and PRECAUTIONS: Instruction for wearing, opening, closing or removing the brace should be provided by a healthcare professional.
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 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 five 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.

OPERATING BOA® LACING AND RELEASE TAB SYSTEM

To Loosen Boa®:

• Lift Boa® Knob. (Figure 1)
• Pull Tab. (Figure 2)

Release Tab

• To allow the brace to open more fully, pull open the hook and loop release tab and free lace. (Figure 3)
• Prior to tightening the brace, place the lace back into the hook and loop release tab and secure hook to loop. (Figure 4)

To Close and Tighten Boa®:

• Push Boa® Knob down. Turn Boa® Knob clockwise. (Figure 5)
• Boa® Knob must be in the down/locked position when wearing a brace.

HEATING AND APPLICATION:

• Open and loosen Boa® as instructed above and unfold the brace.
• Heat brace in Exos® recommended oven for approximately 3 to 4 minutes or until brace is pliable. The brace should not be too hot to handle comfortably.
• Ensure that skin is completely dry before application.
• Apply a brace on the patient.
• Remove slack in lace by tightening Boa® Knob.

Caution: Do not tighten the brace fully until the brace has returned to room temperature otherwise indentations in plastic may occur.

• Mold brace into the desired position. (Figure 6)
• The accessory strap should be secured in the proper position. (Figure 7)
• Once the brace has hardened, the Boa® Knob may be tightened to desired tension.

Warning: The brace should not be worn too tightly. Exos braces are meant to be worn under light pressure and not tight to the skin. A little wiggle room inside an Exos brace promotes air circulation and helps maintain dry, healthy skin. (Figure 8).

PATIENT CLEANING AND STORAGE INSTRUCTIONS:

• Loosen or remove the brace as instructed by a healthcare professional. The brace may be washed or worn while swimming or bathing, only if the healthcare professional allows the patient to loosen or remove the brace. If not, the patient cannot get the brace and skin wet.
• Hand washes inside and outside of brace and skin with antibacterial soap and water (86°F/30°C). (Figure 9).
• Rinse thoroughly with water. NOTE: If not rinsed thoroughly, residual soap may cause irritation, and could deteriorate the material.
• Use a hair dryer set on high volume and cool setting to thoroughly dry the interior of the brace and skin. (Figure 10) It is imperative that the inside surface of the brace and the patient’s skin underneath are completely dry after swimming or bathing. A clean and dry environment inside the brace will help maintain healthy skin and reduce odor and skin issues.
• Retighten the brace. (Figure 11) Exos® Braces are meant to be worn under light pressure and not tight to the skin. A little wiggle room inside an Exos® Brace promotes air circulation and helps maintain healthy dry skin. An over-tightened brace creates “shear” or pressure on the skin during motion and can result in irritation, rash, odor, or skin issues. Wearing the brace too loose will reduce support and may compromise healing.

MATERIAL CONTENTS: EVA foam, spandex, nylon, terpolymer, polyester, steel, nylon 6/6 resin, antimicrobial treatment, polycarbonate, thermoplastic elastomer, polyoxymethylene.
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 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.

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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