DJO DonJoy ROM Advance/ Adjuster User Guide

TROM™ ADVANCE

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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 use 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 TROM Advance is designed to aid in immobilization of the leg and provide a protected range of motion following ACL, PCL, LCL, and MCL surgeries and meniscal repairs. Providing immobilization or controlled movement of the limb or body segment for acute and prophylactic care.
CONTRAINDICATIONS: None

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 the 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 the competent authority in case of a serious incident arising due to usage of this device.

APPLICATION INFORMATION:

1. Unfasten the buckle on each strap and lay the brace out flat. Place leg inside brace and adjust the straps to position bar assembly so that each hinge aligns with the patella (kneecap) and the midline of the leg on both the medial and lateral sides of the leg.

2. Fasten the two straps closest to the knee.

3. Adjust thigh and calf bar length by pushing in the gray button and sliding the strap paddles to the desired length.
   Ensure that both bars are equal in length and that each strap paddle is indexed to the same position on each bar assembly.

4. Fasten the remaining two straps. Loosen the straps by pulling the straps away from the frame, and pull straps tight to remove slack behind the leg while maintaining the position of the hinge and bars on the leg. The straps can be trimmed for proper fit and strap-end can be repositioned to
   the new edge of the strap.

5. To adjust the position of the straps on the leg, push the gray button and slide the strap paddles to the desired location on the leg.

6. To adjust flexion and extension, slide the buttons found on the hinge casing to the desired flexion/extension settings as determined by your prescribing healthcare professional. You may need to move the hinge bar to the desired extension setting on the outer rim of the hinge in order to be able to move the extension button.

7. To lock the hinge, move the hinge bar to the desired setting on the outer rim of the hinge. Slide the hinge lock button, located on the thigh bar, into the locked position such that the arrow moves towards the hinge center.
   A) The hinge bars may be bent to add varus or valgus contouring. Bend each bar by holding the thigh/calf bar firmly against a solid surface and apply gentle and constant pressure to the hinge in the direction desired. Bend each sidebar an equal amount above and below the hinge.
   B) For optimal ease of application post-operatively, pre-fit the brace prior to surgery if possible.

CLEANING INSTRUCTIONS:

Hand wash foam liners in cold water with mild detergent. Air dry only, do not heat dry.
Regular cleaning of the brace is recommended. All foam may be trimmed.
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.
FOR SINGLE PATIENT USE ONLY.
RX ONLY.
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, THERE IS NO GUARANTEE THAT INJURY WILL BE
PREVENTED THROUGH THE USE OF THIS PRODUCT.
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED HEALTH CARE PROFESSIONAL.

MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany

DJO, LLC
1430 Decision Street
Vista CA 92081-8553 • the USA
©2021 DJO, LLC
13-1116 REV E – 2021-01-21

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