Intended Use; Potential Complications - COOK Medical Echotip Instructions For Use Manual

INtENdEd USE

This device is used to sample targeted submucosal gastrointestinal lesions 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.
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.
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.
PRECAUtIONS
Refer to package label for minimum channel size required for this device.
Needle must be retracted into sheath and thumbscrew on safety ring must be
locked to hold needle in place prior to introduction, advancement or withdrawal of
device. Failure to retract needle may result in damage to endoscope.
SYStEM PREPARAtION
1. Examine syringe. It has two plunger locks that must be depressed to advance
plunger. Tip of syringe has a Luer slip fitting with a stopcock on the side port. Air
can be exchanged when stopcock is in "open" position, aligned with syringe. (See
fig. 1)
2. Prepare syringe as follows:
a. With stopcock in "open" position, depress plunger locks and fully advance
plunger into syringe.
b. Turn stopcock 90° to "closed" position.
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ENGLISH
Illustrations