COOK Medical EchoTip ProCore Instrucciones De Uso página 8

ENGLISH
INTENDED USE
This device is used with an ultrasound endoscope for fine needle biopsy,
(FNB), of submucosal and extramural lesions within or adjacent to the
tracheobronchial tree or gastrointestinal tract.
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 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 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, bleeding, damage to blood vessels, nerve damage, pain,
pneumoperitoneum, tumor seeding, respiratory depression or arrest, cardiac
arrhythmia or arrest and death.
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.
8 8