Description of the medical device
The device is made of reinforced corrugated cardboard.
The device is presented flat for easy storage and takes by a very simple operation of unfolding and snapping the shape of a boot. A double-sided adhesive tape locking system fixes the internal reinforcements of the boot.
It is advisable to apply on the injured limb a carded or synthetic cotton protection as it is practiced for immobilization by plaster or resin boot, to minimize the risk of skin rubbing injury at the level of the bony protrusions. This application also ensures good padding adapted to the immobilizing device and the shape of the leg and foot so that the member is well wedged.
The fixation may include sticky strips such as those used to fix the accessories on the surgical drapes if it is desired to avoid manipulation by the patient or by Velcro® strips if it is necessary to ensure progressive tightening or monitoring in the event of a wound or scratches. In all cases an oblique fixation band must be applied at the anterior face of the ankle and the neck of the foot to avoid a piston phenomenon of the heel which would be contrary to the necessity of immobilization. All these accessories are present in hospital services except velcro strips that will be provided by the manufacturer.
The immobilizer does not allow the support of the weight of the body, it is also the case of the plastered boots made in urgency.
The tested medical device is biodegradable but will have to be subject to the medical waste disposal rules.