Tabla de contenido
ENGLISH
INTENDED USE
This device is used for the endoscopic removal of polyps after
polypectomy.
NOTES
Do not use this device for any purpose other than stated intended use.
Store in a dry location, away from temperature extremes.
Use of this device restricted to a trained healthcare professional.
CONTRAINDICATIONS
Contraindications include those specific to primary endoscopic procedure
to be performed in conjunction with removal of polyps.
POTENTIAL COMPLICATIONS
In addition to those associated with gastrointestinal endoscopy
procedures, complications associated with retrieval of a polyp after
polypectomy include, but are not limited to: tissue irritation.
PRECAUTIONS
Refer to package label for minimum channel size required for this device.
This device should never be coiled in less than an 8-inch (20 cm) diameter.
WARNINGS
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 supplied non-sterile, and therefore should not be used in a
sterile field.
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.
INSTRUCTIONS FOR USE
1. With the basket fully retracted into the sheath, insert the device
into an endoscope accessory channel. Advance the device through
the channel in short increments until the basket sheath exits the
endoscope.
2. Endoscopically visualize the polyp to be removed and advance the
basket to the appropriate position.
3. Place the sheath of the basket beyond the target, and slowly extend
the basket to entrap polyp. Note: It may be necessary to move the
basket back and forth along the target in order to capture the polyp.
4. Withdraw the basket into the sheath while maintaining entrapment.
Support the polyp against the endoscope tip, and withdraw the
endoscope from the patient. Maintain endoscopic visualization to
ensure continued entrapment of the polyp. While withdrawing device
from endoscope, wipe secretions from outer sheath.
5. Prepare extracted specimen per institutional guidelines.
2
Tabla de contenido
