Intended Use; Contraindications; Potential Complications - COOK Medical EchoTip Ultra Mode D'emploi

ENGLISH
ECHOTIP ULTRA WITH HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
CAUTION: U.S. Federal Law restricts this device to sale by or on the order
of a physician.

INTENDED USE

This device is used to access or sample submucosal and extramural lesions of
the gastrointestinal tract, access of the following: the intra- or extra-hepatic
bile ducts, pancreatic ducts, cystic duct, gallbladder or for delivery of injectable
materials into tissues through the accessory channel of an ultrasound
endoscope.
NOTES
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.
Do not use this device for any purpose other than stated intended use.
This needle is intended to be used with legally marketed drugs and devices.
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 Medical for return authorization.
This device can be used together with all ECHO compatible products.
Aspiration syringe not intended to be used for injection.
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 site.
Coagulopathy

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, damage to blood vessels, nerve damage and acute pancreatitis.
WARNING
Not for use in the heart or vascular system.
PRECAUTIONS
When performing fine needle injection (FNI), ensure that injectable material
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