gastrointestinal tract.

 A thorough understanding of the technical principles, clinical applications, and risks associated with cold snaring (non-electrical)

polypectomy and tissue resection is necessary before using this product.

 These devices are compatible with an endoscope channel of 2.8 mm or larger.

 Do not attempt to reuse, reprocess, refurbish, remanufacture, or resterilize this device. STERIS Endoscopy did not design this

device nor is it intended to be reused, reprocessed, refurbished, remanufactured, or resterilized. Performing such activities on this

disposable medical device presents a safety risk to patients (i.e. compromised device integrity, cross-contamination, infection).

 Disengage the snare from the polyp if there is a risk of complication.

 Care should be exercised when grasping tissue to avoid inadvertently grasping tissue or organs not intended for retrieval.

 If resistance to insertion is encountered, reduce the angulation (or lower the forceps elevator if applicable) until the instrument

passes smoothly.

 Contraindications include, but are not limited to, those specific to any endoscopic procedure.

2. Ensure that the device is compatible with an endoscope channel of 2.8mm or larger before insertion.

3. Remove the device from the package and uncoil the entire device and drape in a “U” shaped configuration, holding the proximal

end in one hand and the distal sheath in the opposite hand.

1. Insert the device into the biopsy port of the endoscope using short strokes, approximately 1”-1.5” (2.5cm – 3.8cm) in length

throughout device passage to avoid sheath kinking.

2. When the polyp has been endoscopically visualized, extend the distal tip of the catheter into the endoscopic field of view.

3. Gently deploy the snare loop to a fully open position.

4. Place the snare around the polyp tissue being resected using proper endoscopic technique.

5. After the polyp(s) has been satisfactorily resected, the snare should be retracted back into the catheter.

6. The polyp tissue should be collected and the specimen(s) prepared according to standard technique for histologic evaluation.

After use, this product may be a potential biohazard which presents a risk of cross-contamination. Handle and dispose of in

accordance with accepted medical practice and applicable local, state and federal laws and regulations.

An issued or revision date for these instructions is included for the user’s information. In the event that two years have elapsed between

in the country where the incident occurred.

US Endoscopy, a wholly owned subsidiary of STERIS Corporation.