COOK Medical Universa Gebrauchsanweisung Seite 4

• Peritonitis
• Encrustation
• Urinary tract infection
• Loss of renal function.
PRODUCT RECOMMENDATIONS
If no wire guide is provided with this set, the following is recommended:
• 5.0 French stents accept .035"
• 6.0 French stents accept .038"
• 7.0 French stents accept .038"
• 8.0 French stents accept .038"
MRI INFORMATION
Nonclinical testing has demonstrated that the Universa Ureteral Soft Stents
are MR Conditional according to ASTM F2503. A patient with this device may
be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 1.5 tesla or 3.0 tesla only
• Maximum spatial gradient magnetic field of 1600 gauss/cm (16.0 T/m) or
less
• Maximum MR system reported, whole-body-averaged specific absorption
rate (SAR) of < 2.0 W/kg (Normal Operating Mode) for 15 minutes of
continuous scanning
Under the scan conditions defined above, Universa Soft Ureteral Stents are
expected to produce a maximum temperature rise of 1.6°C after 15 minutes of
continuous scanning.
The image artifact extends approximately 6 mm for the Universa Soft Ureteral
Stents as found during nonclinical testing when imaged with a gradient echo
pulse sequence and a 3.0 tesla MR system. The image artifact obscures the
device lumen.
INSTRUCTIONS FOR USE
Endoscopic Placement
NOTE: 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.
1. Pass a flexible wire guide tip to the renal pelvis. Tortuosity in the
obstructed ureter can be resolved using a wire guide and an open-end
ureteral catheter in combination.
2. Using a baseline pyelogram, estimate the proper stent length; add 1
cm to that estimated ureteral measurement. Accurate measurement
enhances drainage efficiency and patient comfort.
3. 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.
4. Watch for the distal end of the stent to appear at the ureterovesical
junction. At that point, halt advancement of the stent.
5. As an assistant removes the wire guide, hold the stent in position with the
positioner. The stent pigtail will form spontaneously.
6. Carefully remove the positioner from the cystoscope.
NOTE: If necessary, final adjustment can be made with endoscopic forceps.
NOTE: The stent may be removed easily by gentle withdrawal traction using
endoscopic forceps.
NOTE: Fluoroscopy facilitates stent placement; however, standard radiography
may be used.
If problems occur using this device, please call your Cook sales representative
or contact our Customer Relations Department.
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended
for one-time use. Sterile if package is unopened or 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
package, inspect the product to ensure no damage has occurred.
REFERENCES
These instructions for use are based on experience from physicians and (or)
their published literature. Refer to your local Cook sales representative for
information on available literature.
T.W. Hepperlen, H.K.Mardis, H. Kammandel: "Self Retained Internal Ureteral
Stents: A New Approach, " The Journal of Urology, 119 (1978), 731.
T.W. Hepperlen, H.K. Mardis, H. Kammandel: "The Pigtail Ureteral Stent in the
Cancer Patient, " The Journal of Urology, 121 (1979), 17.
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.
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