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FLEXOR® URETERAL ACCESS SHEATH
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or a properly
licensed practitioner).
DESCRIPTION
The Flexor Ureteral Access Sheath consists of a ureteral access sheath and a tapered dilator with locking
hub. AQ® hydrophilic coating is applied to the dilator/sheath assembly to ease placement.
INTENDED USE
This device is used to establish a conduit during endoscopic urological procedures, facilitating the passage
of endoscopes and other instruments into the urinary tract. Thirteen (13) cm length is intended for use in
pediatric patients two (2) years of age and over.
CONTRAINDICATIONS
None known
WARNINGS
None known
PRECAUTIONS
Never use undue force for placement of this device.
INSTRUCTIONS FOR USE
NOTE: Prior to placement, activate the hydrophilic coating by removing the dilator from the Flexor sheath
and immersing all components in sterile water or isotonic saline. This will allow the hydrophilic surface to
absorb water and become lubricious, easing placement under standard conditions.
1. Place a .035 inch (0.89 mm) or .038 inch (0.97 mm) diameter wire guide the desired length into the ureter
to establish a working tract.
2. Grasp the sheath just below the instrument adapter and advance the dilator/sheath assembly over the
wire guide and into the ureter. NOTE: Be sure the dilator is securely locked onto the instrument adapter,
ensuring the dilator/sheath assembly can be placed as a single unit, allowing one-hand placement.
3. Confirm the dilator/sheath assembly is properly placed via fluoroscopy.
4. While holding the Flexor sheath in position, unlock the fitting and remove the dilator.
5. Introduce the desired endoscope or instrument as needed.
NOTE: Suture may be utilized to secure the adapter externally. Suture holes are conveniently located on the
instrument adapter.
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
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.
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