COOK Medical N-Circle Instrucciones De Uso página 3

N-CIRCLE® NITINOL HYSTEROSCOPIC POLYP SNARE
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or a properly
licensed practitioner).
DEVICE DESCRIPTION
• Hysteroscopic Polyp Snare with 4-wire nitinol snare
INTENDED USE
Used for manipulation and removal of uterine polyps under direct vision. The nitinol memory wire opens
easily in the uterine cavity allowing capture and removal of polyps. The small diameter sheath permits use
with rigid or flexible hysteroscopes.
CONTRAINDICATIONS
This device should not be used on a patient with an active vaginal or intrauterine infection, a sexually
transmitted disease, a recent uterine perforation, a recent cesarean section, who is currently pregnant, or if
the patient currently has, or suspects she may have an intrauterine device within her uterus.
WARNINGS
• This device is not intended to be used concomitantly with an electrocautery power source. This device
removes polyps by mechanical force alone, and should not be attached to any power source.
PRECAUTIONS
• As some polyps have vascular sources and attachments, there may be noticeable bleeding at the site of
polyp removal. Appropriate care should be taken to treat excessive bleeding including but not limited to,
electrocautery coagulation or tamponade of bleeding site.
• Maximum polyp size is 2cm diameter.
• Described snare techniques are most effective when used to treat pedunculated polyps.
• Excessive force could damage device.
INSTRUCTIONS FOR USING USING N-CIRCLE® NITINOL HYSTEROSCOPIC POLYP SNARE
1. Retract the snare into the sheath.
2. Insert the sheath and snare assembly through the accessory channel of the hysteroscope until the tip is
visualized in the uterine cavity.
3. Open snare near the polyp/tumor and maneuver snare until polyp/tumor is in snare basket.
4. Draw the snare down around the polyp/tumor until slight resistance is felt.
5. Apply gentle traction against polyp to remove the polyp from the uterine wall.
6. Once detached from the uterine wall, maintain purchase of the polyp with the snare basket and retract
scope and snare as one from the uterine cavity to facilitate immediate removal of the polyp body.
7. Re-insert scope and identify any remaining polyp fragments. Those smaller remaining fragments should
be removed with appropriate forceps or graspers.
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if
package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is
sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from the package,
inspect the product to ensure no damage has occurred.
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