COOK Medical Saeed Series, Manual

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ENGLISH
INTENDED USE
This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal
junction or to ligate internal hemorrhoids.
NOTES
This device is supplied non-sterile.
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 restricted to a trained healthcare professional.
CONTRAINDICATIONS
Those specific to primary endoscopic procedure to be performed in gaining access to desired
banding site.
Those specific to esophageal banding include, but are not limited to: cricopharyngeal or
esophageal narrowing or stricture, tortuous esophagus, diverticula, known or suspected
esophageal perforation, asymptomatic rings or webs, coagulopathy.
Those specific to hemorrhoidal banding include, but are not limited to: severe inflammatory
bowel disease, portal hypertension.
Use of ligation bands is contraindicated in patients with a known hypersensitivity to latex.
WARNINGS
This device is designed for single use only. Attempts to reprocess, resterilize, and/or reuse may
lead to device failure and/or transmission of disease.
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.
POTENTIAL COMPLICATIONS
Those associated with gastrointestinal endoscopy include, but are not limited to: perforation,
hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory
depression or arrest, cardiac arrhythmia or arrest.
Those which can occur with esophageal banding include, but are not limited to: retrosternal pain,
nausea, laryngeal laceration, esophageal perforation, stricture formation, obstruction.
Those which can occur with hemorrhoidal banding include, but are not limited to: severe pain,
bleeding, urinary symptoms, swelling and edema, tissue ulceration, bands slipping off.
Hemorrhoidal banding may result in severe pain if the procedure is performed below the
dentate line.
PRECAUTIONS
Refer to package label for minimum channel size required for this device.
Do not use with an overtube. Use with an overtube may result in mucosal pinching/entrapment
and/or barrel detachment.
Band ligation may not be effective when applied to small varices.
Esophageal ligation devices are not intended for ligation of varices below
gastroesophageal junction.
Current literature addresses management of acutely bleeding esophageal varices and does not
address prophylactic use of banding.
Passing endoscope over a previously placed band may dislodge band.
Prior to assembling device, routine endoscopic examination is recommended to confirm
diagnosis requiring treatment of esophageal varices or internal hemorrhoids.
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