DONJOY MKT D00 IsoFORM Postural Extension Instructions

June 5, 2024
Donjoy

DONJOY Logo MKT D00 IsoFORM Postural Extension Clinician Application
Instructions

SIZING:

Size the Brace
BEFORE USING THE DEVICE, PLEASE READ THE INSTRUCTIONS FOR USE COMPLETELY AND CAREFULLY. CORRECT APPLICATION IS VITAL TO THE PROPER FUNCTIONING OF THE DEVICE
Begin by measuring the circumference of the patient approximately 1” (2.5cm) above the widest part of the hips. Then, match the patient’s size to the sizing chart below. If the patient’s circumferential measurement is between sizes, select the larger brace.

SIZE CIRCUMFERENTIAL MEASUREMENT
S/M Less than 48” (122 cm)
L/XL 49” – 60” (125 cm – 152 cm)

NOTE: It is not uncommon for the patient to experience post-surgical swelling, followed by weight loss (10-20+ lbs/4.5-9.1 kg). The Postural Extension brace is designed with two (2) adjustable belts which can be easily sized to achieve optimal fit.

FITTING:
Prepare Brace
Prior to applying, un-hook both pull handles and secure them to the side of the belt. Open the belt by unhooking one hook and looping the side panel from the front panel. Loosen both shoulder straps at the buckle (Figure A). DONJOY MKT D00 IsoFORM Postural Extension - Fig 1

APPLICATION:

Step 1. Apply Brace
Feed one arm through the shoulder strap as if you were applying a backpack; continue with the other arm (Fig. B) DONJOY MKT D00 IsoFORM Postural
Extension - Fig 2Step 2. Position Panels
Position front/anterior panel with the bottom edge aligned with the pubic bone. Secure hook and loop side panel to front panel (Figure C). DONJOY MKT
D00 IsoFORM Postural Extension - Fig 3Step 3. Adjust Shoulder Strap
Adjust the shoulder strap length by pulling on the end of the strap. Be sure to maintain the bottom edge of the front panel with the pubic bone and the back panel between the shoulder blades and lower back (Figure D). DONJOY MKT
D00 IsoFORM Postural Extension - Fig 4Step 4. Tighten Brace
With product in proper position, tighten brace by slipping thumbs through the holes in the pull tabs. Pull away from body. When tightened, secure the pull tabs to the loop exterior (Figure E). Brace Removal
To Remove, release both pull-handles and one side of the belt. Slide the brace off the other shoulder like removing a backpack.
Brace Re-Application
When reapplying the brace, it is easiest to guide the belt by inserting a hand in the donning mitt pocket.

BRACE ADJUSTMENTS:

  • Waist Belt: If needed, to modify the waist belt, adjust the side panels by un-hooking the hook and loop on the back panel and moving panels more center for a smaller waist, or closer to the edge of the back panel for a larger waist.
  • Shoulder Straps: If needed, the extra length in the straps can be trimmed with scissors.
  • Back Panel: Length can be adjusted by loosening the two screws.

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

  1. Open inside panel pocket. Remove semi-rigid panel. (Figure G).
  2. Open the inside panel pocket and insert a semi-rigid panel.

ADJUSTING PULL TAB LENGTH (OPTIONAL):

  1. Remove the lace spool from the pull tab pocket and wind lace around the spool to shorten the length of the pull tab. Unwind lace from the spool to lengthen the pull tab. (Figure F).
  2. Insert lace spool back into pull tab pocket.

ATTACH/REMOVE SOFTGOODS (FOR CLEANING)
Removal of soft goods: Open rear panel pouch and detach waist belt. Remove the rigid rear panel from a pouch.
Waist belt: Detach the rear panel section by unlooping the waist belt from the lacing guide panel. Remove the semi-rigid front panel from the inside panel pocket of the waist belt. Wash soft goods per instructions below. (Figure H)
Attaching soft goods- Waist belt: Reattach tall, rear panel section by looping waist belt through lacing guide panel.
Open the inside panel pocket of the waist belt and replace the semi-rigid front panel. Insert rigid rear panel into the pouch. With a tall, rear panel pouch open, lay waist belt on top with lacing guide facing up. Close pouch.

CLEANING INSTRUCTIONS:

Separate the brace’s removable REAR PANEL before cleaning. Hand washes in cold water, less than 86°F (30°C), using a mild soap. Air dry. NOTE: If not rinsed thoroughly, residual soap may cause irritation and deteriorate the material.
Do NOT iron
Do NOT tumble dry
Do NOT bleach.
INTENDED USER PROFILE:
The user should be able to: Read and understand the directions, warnings, and cautions.
INTENDED USE/INDICATIONS:
The Isoform Postural Extension brace is designed to support and stabilize the spine and may be suitable for people with thoracic spine conditions such as kyphosis, osteoporosis, acute pain, mechanical back pain, compression fractures, strain, and mild scoliosis.
CONTRAINDICATIONS: Pregnancy and circulation, pulmonary, cardiovascular, or skeletal conditions that have a risk to be made worse as a result of compression of the abdomen 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 warrantied timeframe. A brace should not be exposed to moisturizers, chemicals, or solvents, as they may affect durability.
MATERIAL CONTENTS:
Nylon, Polyester, Polyethylene, Polyurethane, Polyethylene, Acrylic, PVC, EVA, Acetal, Aluminum, Steel, Synthetic Rubber
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 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
INTENDED FOR SINGLE-PATIENT USE
Individual results may vary. Neither DJO, LLC nor any of its subsidiaries 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.

https://www.djoglobal.com/products/donjoy/isoform-postural-extension-tlso T 800.336.6569/D 760.727.1280/F 800.936.6569
5919 Sea Otter Place, Suite 200
Carlsbad, CA 92010
The U.S.A.
DJOGlobal.com
Copyright © 2022 by DJO, LLC MKTIS00-12358 Rev A

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