DONJOY X-ACT ROM Lite Knee Brace User Guide

: June 6, 2024
: Donjoy

Table of Contents

BEFORE FIRST USE
WARNINGS AND PRECAUTIONS
APPLICATION INFORMATION
INSTRUCTIONS FOR HINGE ADJUSTMENT
- OTHER ADJUSTMENTS
CLEANING INSTRUCTIONS
Documents / Resources
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)

DONJOY X-ACT ROM Lite Knee Brace

BEFORE FIRST USE

BEFORE USING THE DEVICE, PLEASE READ THE FOLLOWING INSTRUCTIONS COMPLETELY AND CAREFULLY. CORRECT APPLICATION 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 to perform all the directions, warnings and cautions provided in the information for use.

INTENDED USE/INDICATIONS: The DonJoy X-ACT ROM Lite Knee Brace is designed to aid in immobilization of the knee and provide protected range of motion associated with post-traumatic treatment, ACL, PCL, LCL and MCL surgeries, patella realignment and meniscal repairs. Providing immobilization or controlled movement of a limb or body segment. Providing mild protection to a limb or body segment for acute and prophylactic care.

CONTRAINDICATIONS: Do not use if you are allergic to any of the materials contained in this product.

WARNINGS AND PRECAUTIONS

Loss of circulation, patient discomfort and patient re-injury are potential effects caused by device failure.
ROM settings should not be changed without supervision of a medical professional.
This product must be prescribed and fitted by a healthcare professional.
The frequency, duration of use and directions for use should be determined by your healthcare professional.
If pain, swelling, changes in sensation or other unusual reactions occur while using this product, you should contact your doctor immediately.
The support should be snug but not impair circulation.
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.

APPLICATION INFORMATION

Unfasten strap ends and open brace flat.
Place leg on top of flat brace. Shorter upright is applied to the thigh.
Telescope paddles to desired length by depressing the slider button until the desired length is reached. Ensure that both sides are equal in length.
Align the upright with the attached foam liner to midline of leg. Wrap foam pads snugly around leg, leaving the opposite upright unattached, and attach anteriorly as shown. Position and press into place the remaining upright. Make sure medial and lateral hinge height are equal.
Loop the straps through the D-rings and fasten the two straps closest to the knee first, then fasten the remaining straps.
For easy, one piece removal, unfasten the straps and open the foam pads. The brace can then be removed and reapplied as a single unit

INSTRUCTIONS FOR HINGE ADJUSTMENT

7A) Adjust the hinge by depressing the Flexion and Extension buttons inward and rotate stop until the desired angle aligns with button center. Release push button and ensure it is fully retracted to the extend position.

7B) Utilize the quick-lock feature at 0, 15, or 30 degrees, by sliding the red quick lock button inward until the lock is engaged. Ensure uprights do not rotate. If another lock setting is required, see Step 5A and ensure both Flexion and Extension buttons are set at the same angle setting.

OTHER ADJUSTMENTS

The hinge bars may be bent to add varus or valgus contouring.

Bend each bar by holding thigh/calf bar firmly against a solid surface and apply gentle and constant pressure to the hinge in the direction desired.
Bend each side bar an equal amount above and below the hinge.
For optimal ease of application post-operatively, pre-fit the brace prior to surgery if possible.

CLEANING INSTRUCTIONS

Hand wash foam liners in water (30°C) with mild detergent. Rinse thoroughly. AIR DRY only, do not heat dry. Regular cleaning of the brace is recommended.

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.

COMPOSITION: Polypropylene 30%, Aluminum 40%, Nylon 25%, Delrin 3%, Stainless Steel 2%.

RX ONLY INTENDED FOR USE ON A SINGLE PATIENT.

NOT MADE WITH NATURAL RUBBER LATEX