COOK Medical Echotip, Instructions For Use Manual

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ENGLISH
ECHOTIP® ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FOR
OLYMPUS SCOPES
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 sample targeted submucosal and extramural lesions
within or adjacent to the tracheobronchial tree or gastrointestinal tract through
the accessory channel of an ultrasound endoscope for Fine Needle Aspiration
(FNA).
DEVICE DESCRIPTION
The device consists of a handle with adjustable components to allow the user
to adjust the extension of the needle and sheath. The device has a 4.1 Fr outer
sheath for protection of the needle and the scope, and it is attached to the
accessory channel of an Olympus endobronchial ultrasound (EBUS) scope using
an adapter. The device has a maximum needle extension length of 5 cm and
sheath adjustment length of 3 cm. The device is supplied with a 10 ml syringe
to utilize the standard vacuum technique for sample collection, if desired, and
an accessory channel adapter. The device is available in two different needle
sizes: 22 and 25 ga.
CONTRAINDICATIONS
Contraindications include those specific to the primary endoscopic ultrasound
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 ADVERSE EVENTS
Potential adverse events associated with bronchial endoscopy and
gastrointestinal endoscopy include, but are not limited to: allergic reaction to
medication, allergic reaction to nickel, aspiration, cardiac arrhythmia or arrest,
damage to blood vessels, death, discomfort, fever, hemorrhage, hypotension,
infection, inflammation, nerve damage, pain, perforation, pneumoperitoneum,
respiratory depression or arrest, sepsis, septicemia/bacteremia and
tumor seeding.
WARNINGS
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.