COOK Medical Sof-Flex Mode D'emploi page 5

INSTRUCTIONS FOR USE
Wire Guide Preparation
NOTE: If your device did not include a wire guide, then the instructions below are not applicable. If your device did
include a wire guide, please refer to the instructions below for proper use.
1. Using aseptic technique, remove the wire from its outer packaging and place in the sterile field.
2. If using a hydrophilically coated wire guide, fill a syringe with sterile water or sterile saline solution and attach it
to the flushing port on the wire guide holder. Inject enough solution to wet the wire guide surface entirely. This
will activate the hydrophilic coating. NOTE: For optimal performance, rehydrate the hydrophilically coated wire
guide after exposure to ambient environment or, after extended use, replace it with a new hydrophilically coated
wire guide.
3. Remove the wire guide from the holder.
4. If using a movable core wire guide, adjust mandril position by advancing or withdrawing the mandril within the
wire guide to achieve the required degree of flexibility.
Endoscopic Sof-Flex Multi-Length Stent Placement
1. Pass the flexible wire guide tip beyond the obstruction to the renal pelvis. Tortuosity in the obstructed ureter
often can be resolved using the wire guide and an open-end ureteral catheter in combination. Remove catheter
before attempting to place stent.
2. Pass the stent over the wire guide through the cystoscope. Under direct vision, advance the stent into the ureter
with the stent positioner. Have an assistant hold the wire guide in position to prevent advancement of the wire
guide into the renal parenchyma.
3. When the renal pelvis has been entered (Figure A) (this can be confirmed fluoroscopically), gently remove the
wire guide while firmly holding the positioning catheter. The stent coil will form spontaneously in the renal
pelvis. Carefully remove the positioning catheter (Figure B).
• For ureters longer than 22 cm, endoscopic forceps can be used to adjust the stent position, leaving
approximately equal coils in the renal pelvis and bladder.
NOTE: If problems occur using this device, please call your Cook Incorporated sales representative or contact
our Customer Quality Assurance department at the address/phone number listed within this booklet.
Stent Removal
• The stent may be removed by gentle withdrawal traction using endoscopic forceps or tether.
• Retrieve cystoscopically by gently pulling on the stent, and if resistance is encountered during removal,
fluoroscopically determine stent position and cause of resistance.
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is
unopened and 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.
REFERENCES
M. F. Camacho, R. Pereiras, H. Carrion, M. Bondhus, V. A. Politano: "Double-Ended Pigtail Ureteral Stent: Useful
Modification To Single End Ureteral Stent, " Urology, 13 (1979), 516-520.
M. A. Koyle, A. D. Smith: "Ureteral Stents, " Chapter 31 in A. D. Smith, W. R. Castañeda-Zuñiga, J. G. Bronson:
Endourology: Principles and Practice. Thieme Inc., New York, New York, 1986.
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