DJO B08PPWTCKP Irom Elbow Instructions

DJO B08PPWTCKP Irom Elbow Instructions

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/INDICATIONS

The DonJoy IROM Elbow is designed to provide support and immobilization to the elbow. It may be suitable for use following stable distal epicondylar fractures and stable fractures of the distal humerus. Providing immobilization or controlled movement of the limb or body segment.

CONTRAINDICATIONS

• None

WARNINGS AND CAUTIONS

• This product is to be prescribed and fitted by a healthcare professional.
• If you develop an allergic reaction and/or experience  itchy, red skin after coming into contact with any part of this device, please stop using it and contact your healthcare professional immediately.
• Excessive tightening of the brace straps may compromise circulation. If tingling or numbness is experienced, loosen straps.
• Do not use over open wounds.
• If pain, swelling, changes in sensation or other unusual reactions occur while using this product, consult your medical professional immediately.
• 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

1. (A) Open all straps and remove square felt pressure pad.Apply the brace,  with the hinge bar directly over the lateral epicondyle.
   note: The plastic shells may be trimmed with scissors if needed.

2. (B) Begin fastening the straps closest to the elbow with moderate tension. Next, tighten the straps at the top and bottom ends of the brace.

3. (C) Press down, slide out, and lift up the hinge security latch. (Fig. C)
   

4. (D) Rotate the clear plastic cover until the desired flexion or extension pin is exposed. (Fig. D)
   
   

5. (E) Relieve tension on the pin by moving the hinge slightly. Remove the pin and replace it in the desired extension degree setting. Now, repeat this for the flexion degree adjustment. (Fig. E)
   

6. (F) Rotate the security latch past the pin and replace the latch. (Fig. F)
   

7. (G) Attach the hook material at one end of the shoulder strap to the humeral cuff straps as shown.
   Wrap the other end around the wrist and adjust for maximum comfort. (Fig. G)
   
   

USE AND CARE

• The liners may be removed and washed in cold water and mild soap. Air dry.
• Attach liners to the inside of the plastic shells when completely dry.

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, THERE IS NO GUARANTEE THAT INJURY WILL BE PREVENTED THROUGH THE USE OF THIS PRODUCT.

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

DJO, LLC
1430 Decision Street
Vista, CA 92081-8553 • USA

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