DONJOY PNEUMATIC CONDYLE PAD KIT Instructions

DONJOY PNEUMATIC CONDYLE PAD KIT

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.

INDICATIONS

The DonJoy Pneumatic Condyle Pad Kit is designed for use with DJO functional, OA and post-operative knee braces. Providing mild protection of a limb or body segment.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • This device is to be used under the supervision of a healthcare professional.The determination of when to apply the brace and the frequency and duration of use should be strictly at the discretion of the treating physician. Always consult with your physician before making changes to the brace.
  • Do not use over open wounds.
  • Do not modify the device or use the device other than intended.
  • Do not use this device if it is damaged and/or the packaging has been opened.
  • 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.
  • If pain, swelling, changes in sensation or other unusual reactions occur while using this product, you should contact your doctor immediately.

NOTE: Contact manufacturer and competent authority in case of a serious incident arising due to usage of this device.

APPLICATION INFORMATION

A. Remove the current condyle pad(s) from the brace.B. Assemble the pneumatic condyle pad and cover. Place the condyle pad on the brace with valve facing to the front of the knee.C. To inflate the pad, with the brace on your leg, close the pump valve clockwise, moisten the pump needle, gently insert the needle into the pad valve and carefully pump to desired force comfort level. (Fig. 1).D. To deflate the pad, with the brace on your leg, moisten the pump needle, gently insert the needle into the pad valve and carefully open (counter clockwise) the pump valve to release the desired amount of air. (Fig. 2).

USE AND CARE

  • Hand wash in cold water with mild soap. AIR DRY ONLY, DO NOT HEAT DRY PADS.
  • Do not submerge pad valve in water. Valve seal quality may be maintained by using a small amount of petroleum jelly on a regular basis.

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. To the extent the terms of this warranty are inconsistent with local regulations, the provisions of such local regulations will apply.

FOR SINGLE PATIENT USE ONLY

NOT MADE WITH NATURAL RUBBER LATEX. Rx only.

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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