Intended Use - COOK Medical Evolution Instrucciones De Uso

ENGLISH
EVOLUTION® DUODENAL STENT SYSTEM - UNCOVERED
IMPORTANT INFORMATION
Please review prior to use.

INTENDED USE

This device is used for palliative treatment of duodenal or gastric outlet
obstruction and duodenal strictures caused by malignant neoplasms.
STENT DESCRIPTION
This flexible, self-expanding stent is constructed of a single, woven,
nitinol wire. The stent foreshortens due to its design. The total length
of the stent is indicated by radiopaque markers on the inner catheter,
indicating the actual length of the stent at nominal stent diameter.
This Stent is supplied sterile and is intended for single use only.
DELIVERY SYSTEM DESCRIPTION
The stent is mounted on an inner catheter, which accepts a .035 inch
wire guide, and is constrained by an outer catheter. An endoscopically
and fluoroscopically visible yellow marker defines the proximal end of
the stent when constrained in the catheter. A pistol-grip delivery handle
allows stent deployment or recapture.
This Delivery System is supplied sterile and is intended for single use
only.
NOTES
Do not use this device for any purpose other than stated intended use.
If package is opened or damaged when received, do not use. Visually
inspect with particular attention to kinks, bends and breaks. If an
abnormality is detected that would prohibit proper working condition,
do not use. Please notify Cook for return authorization.
Use of this device is restricted to a trained healthcare professional.
Store in a dry location, away from temperature extremes.
CONTRAINDICATIONS
Those specific to GI endoscopy and any procedure to be performed in
conjunction with stent placement.
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