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Idiomas disponibles
Idiomas disponibles
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ENGLISH
INTENDED USE
This device is used for hemostasis of nonvariceal 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.
WARNING
Keep catheter tip at least 1 cm away from bleeding site to minimize risk of
embolization.
Hemospray has not been approved for use in pediatric populations, no
safety or effectiveness data exists and would be considered off-label usage,
to do so is at the professional risk of the surgeon/healthcare professional.
Patients with gastrointestinal bleeding that are on antithrombotic
medication may be at an increased risk of rebleeding. Follow the
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