Intended Use; Contraindications; Potential Complications - COOK Medical EchoTip Ultra Gebrauchsanweisung

ENGLISH

INTENDED USE

This device is used to sample targeted submucosal and extramural lesions
within or adjacent to the tracheobronchial tree or gastrointestinal tract through
the accessory channel of an ultra sound endoscope for Fine Needle Aspiration
(FNA).
NOTES
Do not use this device for any purpose other than stated intended use.
If the 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.
Store in a dry location, away from temperature extremes.
Use of this device is restricted to a trained healthcare professional.
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.
This device is intended for use with an Olympus EBUS scope.

CONTRAINDICATIONS

Contraindications include those specific to the primary endoscopic procedure
to be performed in gaining access to the desired position to visualize the
targeted site.
Relative contraindications include, but are not limited to: coagulopathy.

POTENTIAL COMPLICATIONS

Potential complications associated with bronchial endoscopy and
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 and
tumor seeding.
WARNING
Not for use in the heart or vascular system. The tip of the needle and stylet are
sharp and could cause injury to the patient or user if not used with caution.
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