3
WARNINGS
MR SAFETY INFORMATION
This symbol means the device is MR Safe.
The Cotton-Leung Sof-Flex Biliary Stent is MR Safe.
In non-clinical testing, the image artifact caused by the device extends approximately
7 mm from the stent when imaged with a gradient echo pulse sequence and a 3 T MR
system.
INSTRUCTIONS FOR USE
1. Gently ensure full extension of all side flaps.
2. Load positioning sleeve onto duodenal flap end of stent.
For 5 to 7 FR stents:
3.a. Introduce stent, tapered tip first, and positioning sleeve onto a pre-positioned wire
guide.
For 8.5 FR and larger stents:
3.b. Remove Tuohy-Borst adapter from end of guiding catheter, then introduce guiding
catheter into accessory channel over a pre-positioned wire guide.
3.c. Introduce stent, tapered tip first, and positioning sleeve onto guiding catheter and
pre-positioned wire guide.
Then refer to steps 4-7 below.
4. Advance guiding catheter* and/or pushing catheter in 1-2 cm increments until stent is
in desired position.
5. Fluoroscopically and endoscopically confirm desired stent position. Replace Tuohy-
Borst adapter onto end of guiding catheter*. Inject contrast, if desired, to fluoroscopically
visualize stent position.
6. After confirming stent position, gently remove wire guide, then guiding catheter*
from endoscope while maintaining position of stent with pushing catheter.
7. Gently remove pushing catheter from accessory channel.
Upon completion of procedure, dispose of introducer components per institutional
guidelines for biohazardous medical waste.
* (if any)
