COOK Medical Universa Mode D'emploi page 4

SUGGESTED INSTRUCTIONS FOR USING UNIVERSA™ STENT SETS
ENDOSCOPIC PLACEMENT
1. Pass a flexible wire guide tip to the renal pelvis. Tortuosity in the obstructed
ureter often 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. Care should
be taken not to allow the wire guide to advance into the renal parenchyma.
4. When the distal end of the stent is observed at the ureterovesical junction,
halt advancement of the stent. While stabilizing the stent with the positioner,
remove the wire guide. The stent pigtail will form spontaneously. Carefully
remove the positioner from the cystoscope. Note: If necessary, final adjustment
can be performed with endoscopic forceps. The stent may be removed easily
by gentle withdrawal traction using endoscopic forceps. Fluoroscopy facilitates
stent placement; however, standard radiography may be used.
CAUTIONS
Intended for one-time use only. The Universa™ Firm stent must not remain
indwelling more than twelve (12) months. The Universa™ Soft stent must
not remain indwelling more than six (6) months.
These stents are not intended as permanent indwelling devices. Periodic
evaluation via cystoscopic, radiographic or ultrasonic means is suggested.
Individual variations of interaction between stents and the urinary system
are unpredictable. The stent must be removed if encrustation hampers
drainage. The stent may be replaced with a new stent, if the patient's
status permits.
Do not force components during removal or replacement. Carefully remove
the components if any resistance is encountered. A pregnant patient must
be more closely monitored for possible stent encrustation due to calcium
supplements.
Improper handling can seriously weaken the stent. Acute bending or
overstressing during placement may result in subsequent separation of the
stent at the point of stress after a prolonged indwelling period. Angulation
of the wire guide or stent should be avoided. Use of a 0-degree scope lens
is recommended. Scopes larger than 21.0 French are suggested.
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