COOK Medical FLEXOR PARALLEL RAPID RELEASE Gebrauchsanweisung Seite 4

ENGLISH
FLEXOR® PARALLEL™ RAPID RELEASE™ 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).
DEVICE DESCRIPTION
• Ureteral access sheath and tapered dilator with locking hub (AQ® hydrophilic coating is applied to the dilator/
sheath assembly to ease placement.)
• Wire guide backloading clip
NOTE: Set components may vary.
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.
CONTRAINDICATIONS
None known
WARNINGS
None known
PRECAUTIONS
• Never use undue force for placement of this device.
• Never use undue force while releasing the wire in the rapid release technique.
• To reduce the likelihood of trauma, use the rapid release technique once per device.
• During placement, the likelihood of the device slipping off the wire guide increases if a soft wire guide is used. A
stiff wire guide is recommended for best performance.
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.
Traditional Placement Technique
1. Place a .038 inch (0.97 mm) diameter wire guide the desired length into the ureter to establish a working tract.
2. Ensure the dilator is securely locked onto the instrument adapter, allowing the dilator/sheath assembly to be
placed as a single unit with one hand.
3. Grasp the sheath just below the instrument adapter and advance the distal tip of the dilator/sheath assembly
over the wire guide and into the ureter.
4. Confirm the dilator/sheath assembly is properly placed via fluoroscopy.
5. While holding the Flexor sheath in position, unlock the fitting and remove the dilator and wire.
NOTE: The arrow on the dilator clip indicates the orientation in which the skive is facing. If negotiating
tortuous or curved anatomy, rotate the secured dilator and sheath so that the arrow on the clip is facing
toward the apex of the curve (away from the curve).
6. Introduce the desired instrument as needed.
7. Suture may be utilized to secure the adapter externally. Suture holes are located on the instrument adapter.
Rapid Release Technique
1. Place a .038 inch (0.97 mm) diameter wire guide the desired length into the ureter to establish a working tract. A
stiff wire guide is recommended for best results.
4