DJO 13-9226 ProCare Personal Limb Holder User Guide

DJO 13-9226 ProCare Personal Limb Holder 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 or caregiver should be able to read, understand and be physically capable of performing all the directions, warnings and cautions provided in the information for use.

INTENDED USE/INDICATIONS

Intended for Patients who are at risk for disturbing medical treatment by pulling their IV line and/or catheter or are prone to self-injury. This device is designed for use in a bed or on a stretcher.

PERFORMANCE CHARACTERISTICS

Providing temporary immobilization of limb or body segment to reduce or restrict motion.

CONTRAINDICATIONS

This restraint is not designed for use on combative or agitated patients.

WARNINGS AND PRECAUTIONS

• Failure to follow instructions for proper application may result in serious injury.
• Discontinue use when torn, worn, frayed or damaged in any way.
• Do not use on combative patients.
• When a patient is in a restrictive product in bed or on a stretcher or gurney, all side rails MUST be in the UP position.
• All straps must be checked routinely to be sure they are secure.
• All straps must be secured short enough so the patient cannot become entangled.
• Always monitor patient when using a restraining device.
• Tighten straps without restricting patient’s circulation.
• Always inspect product prior to application to ensure all parts are in proper working order.
• Do not use over open wounds.
• If pain, swelling, changes in sensation or other unusual reactions occur while using this product, you should contact your doctor immediately.
• Do not use if you are allergic to any of the materials contained in this product.
• If you have skin disorders/injuries in the relevant part of the body, the product should be fitted and worn only after consultation with a medical professional.

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

APPLICATION INFORMATION

1. Place limb holder over patient’s limb with teardrop opening on the outside of the limb. (Fig 1)
2. Thread opposite strap through teardrop opening. (Fig 2)
3. Loop strap around limb a second time. (Fig 3)
4. Pull strap through opening to complete two wraps around limb. (Fig 4)
5. Holding double looped strap, bring remaining strap around the limb. (Fig 5)
6. Tie square knot at outside of limb and adjust for snug fit. Extend straps and secure in desired location. (Fig 6)

RX only

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.

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.

©2021 DJO, LLC
13-9226 REV C – 2021-02-25

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