DONJOY 11-2151-9 X-ROM Post-Op Knee Brace Instruction Manual

: June 6, 2024
: Donjoy

Table of Contents

DONJOY 11-2151-9 X-ROM Post-Op Knee Brace
APPLICATION INFORMATION:
WARRANTY:
CAUTION:
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DONJOY 11-2151-9 X-ROM Post-Op Knee Brace

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: To aid in immobilization and protected range of motion associated with ACL, PCL, LCL, and MCL surgeries and meniscal repairs.

PERFORMANCE CHARACTERISTICS:
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: Unstable knees requiring operative therapy, open wounds, cellulitis or lacerations that will be occluded by the brace. Do not use if you are allergic to any of the materials contained within this product.

WARNINGS AND CAUTIONS:

If you experience any pain, swelling, sensation changes, or any unusual reactions while using this product, consult your medical professional immediately.
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.
Please be advised that DJO, LLC, does not recommend simultaneous wearing of functional knee braces bilaterally (right and left legs), during activities (ie skiing) that may cause the braces to contact each other, resulting in potential loss of control and injury.
The support should be snug but not impair circulation. Rigid knee braces are not recommended to be worn over clothing.
Do not use over open wounds. Do not use this 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 near black buckles and open brace flat by pulling both uprights apart.
Place leg on top of flat brace. Shorter upright is applied to the thigh. Adjust brace until each upright is aligned to centerline of the medial and lateral sides of the leg and the center of the hinge is aligned with the center of the knee joint.
Telescope sliders by depressing the slider button until the desired length is reached. The top and bottom sliders should be adjusted first, followed by the sliders closest to the knee (note that inner sliders cannot be adjusted until the outer sliders are moved to provide sufficient clearance). Ensure that both bars are equal in length and that each strap slider is indexed to the same position on each upright respectively.
Adjust the strap lengths:
- Ensure tab is lifted from the strap, allowing the strap to move freely (see arrow position A in figure 4) By pulling strap away from the body, remove slack from the backside of brace (see arrow position B in figure 4)
- Ensure uprights are aligned on medial and lateral sides of leg
- Lower tab and apply pressure to secure strap
Attach each of the black buckles. Tighten straps by pulling on loose end. Remove excess strap and reposition alligator strap end to new edge of the strap. Secure strap-end to strap.
A) Adjust the hinge by pulling the Flexion and Extension stops outward and rotating until the desired angle aligns with the button center. Release stops and ensure they are fully inserted.
B) Utilize the quick-lock feature at -10, 0, 10, 20, or 30 degrees, by aligning red arrow with desired degree and 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 6 and ensure both Flexion and Extension buttons are set at the same angle setting.
To remove brace, release each buckle. Brace can then be re-applied as a single unit.

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.

STRAP REPLACEMENT: Should straps require replacement, carefully use scissors to cut away the strap where it connects to the slider. Insert the new strap and secure. Contact DJO for the X-ROM Replacement Straps Kit.

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.

COMPOSITION: Nylon 50%, Aluminum 40%, Polypropylene 5%, Delrin 3%, Stainless Steel 2%.

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.
Rx ONLY.
INTENDED FOR SINGLE PATIENT USE.
NOT MADE WITH NATURAL RUBBER LATEX.

NOTICE: WHILE EVERY EFFORT HAS BEEN MADE IN STATE-OF-THE-ART TECHNIQUES TO OBTAIN THE MAXIMUM COMPATIBILITY OF FUNCTION, STRENGTH, DURABILITY AND COMFORT, THIS DEVICE IS ONLY ONE ELEMENT IN THE OVERALL TREATMENT PROGRAM ADMINISTERED BY A MEDICAL PROFESSIONAL. THERE IS NO GUARANTEE THAT INJURY WILL BE PREVENTED THROUGH THE USE OF THIS PRODUCT.