Prior to use, immerse stent in sterile water or isotonic saline to allow the hydrophilic surface to absorb water and become lubricious.
This will ease placement under standard conditions.
Load stent over the guide wire and advance to port element of scope.
Stent should be advanced to point where a portion of the shaft resides
outside the scope port element.
Advance stent pusher over guide wire until pusher abuts the stent shaft.
Advance pusher until stent head positioned in renal pelvis.
Retract guide wire and confirm pigtail curl in renal pelvis.
Carefully remove guide wire and pusher from patient once stent position confirmed.
These Instructions for Use are provided for informational
purposes only and are not intended to take the place of product labeling.
Knowledge of physician specialists with comprehensive knowledge of the indications, techniques and risks of
the procedure is preferential to this instruction for use.
This product contains NO natural rubber latex.
- Anti-Microbial Coating prevents growth of commonly occurring organisms on or around the stent.
- This device is supplied sterile and recommended for one-time use only.
- Avoid bending or kinking the stent during or prior to placement as to do so could damage the integrity of the stent.
- If resistance is encountered during advancement or withdrawal of the stent, STOP. Do not continue without first determining the cause of resistance and taking remedial action.
- Periodic radiographic, isotopic, or cystoscopic examinations are recommended to evaluate stent efficiency and to observe for possible complications.
- This stent is not intended to be a permanent implant device.
- The recommendations given herein are meant to serve only as a basic guide to the utilization of this device. Use of this device should be restricted to physician specialists with comprehensive knowledge of the indications, techniques and risks of the procedure.
- A pregnant patient must be more closely monitored for possible stent encrustation due to calciu/m supplements.
Sterile if the package is unopened or undamaged. Do not use if package is broken.
If no wire guide is provided with this set, the following is recommended:
- 3.0 French stents accept .018”
- 4.0 French stents accept .028”
- 4.8 French stents accept .028”
- 6.0 French stents accept .035”
- 7.0 French stents accept .035”
- 8.0 French stents accept .035”
For single use only. DO NOT REUSE, REPROCESS OR RESTERILIZE. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which in turn may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.