Intended Use; Contraindications - COOK Medical Universa Mode D'emploi

ENGLISH

INTENDED USE

Used for temporary internal drainage from the ureteropelvic junction to the
bladder. Ureteral stents have been employed to relieve obstruction in a variety
of benign, malignant, and post-traumatic conditions. These stents may be
placed using endoscopic, percutaneous, or open surgical techniques. The multi-
length stents will accommodate ureters from approximately 22-32cm in length.
NOTES
If the package is opened or damaged when received, do not use. Visually
inspect with particular attention to kinks, bends and breaks. If an abnormality
is detected that would prohibit proper working condition, do not use. Please
notify Cook for return authorization.
Do not use this device for any purpose other than the stated intended use.
Inventory rotation of sterile products is essential. Verify the expiration date of
the package label prior to using the product. If the expiration date has lapsed,
do not use or resterilize the device. Store in a dark, dry location, away from
temperature extremes.
SET CONTAINS (set components may vary)
• Radiopaque double pigtail/multi-length stent
• Stent Positioner
• Roadrunner hydrophilic wire guide (-RPC) or stainless steel wire guide
• Lockable Pusher (-LP stents)
• Closed End Stent (-CE stents)
• Pigtail Sideports only (-P stents)
• Distal Pigtail Sideports only (-PD stents)
• Tether (-T)
• Stent only (-B)
Note:
If no wire guide is provided with this set the following is recommended;
• 5.0 French stents accept .035'' diameter
• 6.0, 7.0, 8.0 French stents accept .038'' diameter

CONTRAINDICATIONS

There are no known contraindications.
CAUTIONS
Complications of ureteral stent placement are documented. Use of this
device should be based upon consideration of risk-benefit factors as they
2