EchoTip® Ultra® HD Endoscopic Ultrasound Needle .
INSTRUCTIONS FOR USE (IFU):
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MORE INFO:
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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.
