DONJOY 12357 Isoform Tlso Patient Instruction Manual

: June 15, 2024
: Donjoy

Table of Contents

DONJOY 12357 Isoform Tlso Patient
Product Information
Product Usage Instructions
Frequently Asked Questions
RE-APPLICATION INSTRUCTIONS
BRACE REMOVAL
CLEANING INSTRUCTIONS
INTENDED USE
CONTRAINDICATIONS
WARNINGS AND CAUTIONS
MATERIAL CONTENTS
WARRANTY
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DONJOY 12357 Isoform Tlso Patient

Product Information

Specifications

Material Contents: Nylon, Polyester, Polyethylene, Polyurethane, Polypropylene, Acrylic, PVC, EVA, Acetal, Aluminum, Steel, Synthetic Rubber, Glass, Calcium Carbonate
Not Made with Natural Rubber Latex
Warranty: DJO, LLC will repair or replace all or part of the unit and its accessories for material or workmanship defects for six months from the date of sale.
Intended Use: For single-patient use only

Product Usage Instructions

Step 1: Re-Apply Brace

While standing, slide the TLSO on like you might put on a jacket or backpack, keeping your head between the two shoulder straps.
Lower the TLSO into position and refasten the quick-release buckle at the top.
Let the front/anterior panel and back/posterior panel hang over the torso.

Step 2: Close Panels
Close both of the compression side panels so that they are even and comfortably snug on the Anterior Panel.

Step 3: Activate Compression

Grasp the pull handle and pull straight out from the torso.
After achieving the desired level of compression, fasten the pull handle to the anterior portion of the compression panels.
Adjust compression after five minutes and re-adjust as needed.

Brace Removal

Release the compression handles and then release one of the shoulder strap buckles.
Slide the orthosis off the other shoulder like removing a jacket or backpack.

Cleaning Instructions
Follow the cleaning instructions provided in the user manual for proper maintenance of the brace.

Frequently Asked Questions

Q: Can pregnant individuals use this product?

A: No, pregnancy is listed as a contraindication due to potential risks associated with compression and pressure.

Q: How long is the warranty period for this product?

A: The warranty covers material or workmanship defects for six months from the date of sale.

Q: Is it safe to use hot/cold packs with this product?

A: Yes, hot/cold packs can be used with this product by following the specific instructions provided for their use.

RE-APPLICATION INSTRUCTIONS

Step 1. Re-Apply Brace
While standing, slide the TLSO on ( like you might put on a jacket or backpack).-keeping head between the two shoulder straps. (Figure A) Lower the TLSO into position. Refasten the quick-release buckle at the top. (Figure B)Let the front/anterior panel and back/posterior panel hang over the torso. (Figure C)

Step 2. Close Panels
Close both of the compression side panels so that they are even and comfortably snug on the Anterior Panel. (Figure D)

Step 3. Activate Compression
Grasp pull handle and pull straight out from the torso. After the desired level of compression has been achieved, fasten the pull handle to the anterior portion of the compression panels. Adjust compression after five minutes, then re-adjusting as needed. (Figure E & F)

BRACE REMOVAL

Step 1.
Release the compression handles (Figure E) then release one of the shoulder strap buckles. (Figure B)
Step 2.
Slide the orthosis off the other shoulder like removing a jacket or backpack. (Figure A)

HOT/COLD PACK (sold separately):
Follow instructions on the hot/cold packs. Insert hot/cold pack into a pocket and adhere to the back panel.

CLEANING INSTRUCTIONS

Separate the brace’s removable REAR PANEL before cleaning. Hand wash in cold water, less than 86°F (30°C), using a mild soap. Air dry. NOTE: If not rinsed thoroughly, residual soap may irritate and deteriorate the material. Do NOT iron/Do NOT tumble dry/Do NOT bleach.

INTENDED USE

INTENDED USER PROFILE:
The user should be able to: Read and understand the directions, warnings, and cautions.
INTENDED USE/INDICATIONS:
The Isoform® TLSO brace is designed to support and stabilize the spine for acute pain relief through postural extension alignment and may be suitable for people with compression fractures of the thoracic spine, osteoporosis, thoracic mechanical pain, and kyphosis.

CONTRAINDICATIONS

Pregnancy and circulation, pulmonary, cardiovascular, or skeletal conditions that have the risk of being made worse as a result of compression and/or pressure

WARNINGS AND CAUTIONS

If you experience any pain, swelling, sensation changes, excessive discoloration, irritation to the skin, or any unusual reaction while using this product, consult your medical professional. If any distortion of the support panels, fraying, or deterioration of lace cables is noticed, discontinue use. The brace is intended to be worn over clothing. The brace should be appropriately sized for the patient to ensure proper support and function. If the brace does not fit properly, it may be adjusted by a healthcare professional. Care should be taken with patients, especially the elderly, not to apply the brace too tightly, which MAY cause excessive pressure. Patients should be instructed on appropriate tensioning during ongoing use. Patients should see a healthcare professional for a replacement if a product quality issue occurs within the warranty timeframe. Braces should not be exposed to moisturizers, chemicals, or solvents, as they may affect durability.

MATERIAL CONTENTS

Nylon
Polyester
Polyethylene
Polyurethane
Polypropylene
Acrylic
PVC
EVA
Acetal
Aluminum
Steel
Synthetic Rubber
Glass
Calcium Carbonate

NOT MADE WITH NATURAL RUBBER LATEX

WARRANTY

DJO, LLC will repair or replace all or part of the unit and its accessories for material or workmanship defects for 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. INTENDED FOR SINGLE PATIENT USE.

Product Support:

Phone: 888.405.3251
Email: [email protected].

Individual results may vary. Neither DJO, LLC nor any of the Enovis companies dispense medical advice. The contents of this document do not constitute medical, legal, or any other type of professional advice. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you.