Steris Infinity 00711652 Mode D'emploi page 3

Directions for Use (Short Guidewire technique):
1. Carefully retract the brush into the catheter past the radiopaque band near the tip of the catheter.
2. When using a guidewire, irrigate the guidewire lumen of the catheter with sterile water/saline.
3. After selective cannulation of the desired duct is achieved and the guide wire is placed beyond the desired site for brushing:
a. Advance the Infinity
b. Observe the guidewire as it exits the hole approximately 20 cm from the tip of the catheter.
c. If using a guidewire locking device, unlock the short guidewire per manufacturer's recommendations.
d. Advance the device into the accessory channel of the endoscope and relock the guidewire.
Using short strokes (1" – 1.5"), continue to advance the device until the distal end of the sheath is endoscopically visualized.
4.
5. Advance the catheter using fluoroscopic guidance to the desired location.
6. Using the spool handle and thumb ring, slowly advance the brush out of the catheter and brush the desired area in order to
obtain adequate cellular material. Brushing of the desired area will be easier with the endoscope elevator open.
When brushing is complete, retract the brush into the catheter and remove the Infinity™ sampling device using accepted short
7.
wire exchange technique.
8. Properly prepare the specimen per institution guidelines for cytological evaluation. If salvage cytology is desired, see
Directions for Use (Salvage Cytology).
Directions for Use (Salvage Cytology):
1. Warning: Do not rapidly flush the catheter when performing salvage cytology. Scatter of bodily fluids and debris could occur. Cut
the brush close to the bristles using an appropriate cutting device.
2. Detach brush handle from the handle luer lock.
3. Remove the entire handle assembly with the drive wire from the catheter.
4. Attach a sterile 5cc syringe filled with fresh cytology solution and attach the syringe to the handle luer lock.
5. Flush the catheter contents into the cytology container; repeat until catheter is cleared, followed by air in order to evacuate any
residual contents.
6. Properly prepare the specimen per institution guidelines for cytological evaluation.
Product Disposal:
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.
Issued Date: October 2019
Warning:
An issued or revision date for these instructions is included for the user's information. In the event that two years have elapsed between
this date and product use, the user should contact STERIS to determine if additional information is available.
Unless otherwise indicated, all marks denoted with ® or ™ are registered with the U.S. Patent and Trademark Office, or are trademarks
owned by STERIS Corporation.
Serious incidents that have occurred in relation to this medical device should be reported to the manufacturer and competent authority
in the country where the incident occurred.
US Endoscopy, a wholly owned subsidiary of STERIS Corporation.
Made in the U.S.A.
00732074 Rev. E
®
ERCP sampling device over the guidewire.
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