DONJOY DJ9121 X-Act ROM Elbow Pronation/Supination Kit User Guide
- June 6, 2024
- Donjoy
Table of Contents
DONJOY DJ9121 X-Act ROM Elbow Pronation/Supination
Kit User Guide
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 of performing the directions, warnings and cautions in the information for use.
INTENDED USE/INDICATONS : The DonJoy X-Act ROM Elbow Pronation/ Supination Kit is to be used with the DonJoy X-Act ROM Elbow. It is designed to provide fixed positioning for the hand and wrist and may be suitable for use following stable fractures. Providing mild protection of a limb or body segment.
CONTRAINDICATIONS: Do not use if you are allergic to any of the materials contained within this product.
WARNINGS AND PRECAUTIONS:
- This product is to be prescribed and fitted by a healthcare professional.
- A healthcare professional must determine the proper positioning for the patient following surgery.
- Excessive tightening of the brace straps may compromise circulation. If tingling or numbness is experienced, loosen straps.
- If pain, swelling, changes in sensation or other unusual reactions occur while using this product, consult your medical professional immediately.
- 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:
Attachment is shipped in Neutral position. For Pronation or Supination, set attachment in desired position per instructions below. Place patient in brace while in Pronation or Supination position, then secure brace.
To Set Attachment for Pronation
- Remove pad on cuff of Pronation/Supination attachment and reveal barrel nuts (Fig A).
- Loosen screws enough to slide hand piece toward distal slider to proper position. Retighten screws (Fig B).
- Replace pad on cuff and attach cuff to X-Act Rom Elbow brace per instructions below.
To Set Attachment for Supination
- Remove pad on cuff of Pronation/Supination attachment and reveal barrel nuts ( Fig A ).
- Remove screws and barrel nuts from hand piece ( Fig B ).
- Move barrel nuts, screws and handpiece to opposite side of cuff ( Fig C ).
- Replace handpiece and screws, position hand piece in proper position and tighten screws ( Fig D ).
- Rotate tubing so hand strap is on top of hand when secured ( Fig E ).
Application of Pronation/Supination Attachment to Elbow Brace
- Remove distal (wrist) cuff on X-Act ROM Elbow brace by depressing the slider button and pulling cuff off end of brace. Note: Button must be completely depressed to clear bar in order to remove Cuff.
- Depress button of Pronation/Supination attachment and slide onto bar making sure cuff is aligned with other three sliders/cuffs on brace. Adjust and lock slider in proper location for patient.
- Apply brace on patient. Make sure Pronation Supination handpiece is in proper position defined by clinician.
- Secure handpiece strap, making sure hand strap is positioned on dorsal (top) side of hand (Fig E).
- Secure cuffs and straps of brace per the DonJoy X-Act ROM Elbow Instructions for Use and set hinge as prescribed. Note: The two Cuffs closest the hinge (forearm and lower bicep) should be secured first, followed by two farthest from hinge (wrist and upper bicep). Straps for each cuff should be secured in same sequence.
CLEANING INSTRUCTIONS: Remove and hand wash preformed cuff liners and brace straps in warm water (86°F/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.
MATERIAL CONTENT : Nylon, Aluminum, Plastic, Lycra, Foam INTENDED FOR USE ON A SINGLE PATIENT • 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, 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.
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED HEALTH CARE PROFESSIONAL.
©2020 DJO, LLC
13-6502 REV C
12-29-2020