Design Features - darco HeelWedge Mode D'emploi

EN Instructions for use
HeelWedge® | Off-loading Shoe
Important notes
If there is a serious deterioration in your state of health as a result of using the medical
device, please report this to your specialist dealer or the manufacturer as soon as possible. If you
report this to the specialist dealer, the dealer will forward this immediately. The reports are agreed
with and processed by the competent authorities.
Please always follow these instructions for use. In case of adverse effects (e.g. skin swelling, pressure
points, disorders of blood circulation etc.) please tell your doctor. Function and optimum protection
are no longer guaranteed if the product is handled incorrectly. This aid assists recovery and should be
used exclusively under the instruction of and in consultation with your doctor or a healthcare profes-
sional. DARCO (Europe) GmbH does not assume any responsibility for misuse of the product does not
assume any responsibility. Do not wear the product with injured, irritated, damaged or broken skin.
You should use bandages or socks, for example.
Do not drive a vehicle while you are wearing this device. Use extreme caution when walking on all
surfaces when using this device. Walk more slowly than normal.
This device is intended for single-patient use only.
Purpose
The HeelWedge® off-loading shoe is designed to promote healing by reducing weight from the
rearfoot. It and may be used for any condition requiring weight or pressure reduction from the
metatarsal heads proximally for conditions such as ulcers, infections, trauma and surgery.
Indications / Contraindications
Indications
> Postoperative healing for either soft tissue or bony
structure of the heel
> Selective off-loading after fractures
> For the treatment of ulcerations present on the heel area
(rear foot ulceration)

Design features

The shortened sole provides effective pressure off-loading. The removable insole can be exchanged
by the PegAssist® Insole.
Working life / Lifespan of the product
The lifespan of the medical device is determined by natural wear and tear due to proper handling
/ cleaning. The medical device is designed to be used for the duration of use prescribed by a doctor
(usually about 6 weeks) without showing a reduction in safety or performance. After the period
of use prescribed by your doctor, check the function of the product together with your medical
professional.
Contraindications
> Open fractures