Intended Use; Device Description - COOK Medical Hemospray Manual Del Usuario

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INTENDED USE

This device is used for hemostasis of nonvariceal upper gastrointestinal bleeding.
NOTES
Do not use this device for any purpose other than stated intended use.
Store in a dry location, away from temperature extremes.
Use of this device is restricted to a trained healthcare professional.

DEVICE DESCRIPTION

Hemospray is an inert, bentonite powder developed for endoscopic hemostasis. The powder is
delivered by use of a carbon dioxide powered delivery system and through a catheter inserted
through the working channel of an endoscope which provides access to the site of the bleed.
Each device contains approximately 20g of powder.
CONTRAINDICATIONS
Those specific to primary endoscopic procedure to be performed in gaining access to desired
target site. Also contraindicated in patients who have gastrointestinal fistulas, are suspected of
having a gastrointestinal perforation, or are at high risk of gastrointestinal perforation during
endoscopic treatment.
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