How Supplied; Určené Použití - COOK Medical FLEXOR PARALLEL RAPID RELEASE Gebrauchsanweisung

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. A wire guide backloading clip is included to aid backloading of soft wires. For soft wires, place the angled tooth
of the wire guide backloading clip into the skive and attach the wire guide backloading clip to the sheath. Place
thumb on wire guide backloading clip for stability. For stiffer-ended wires, the wire guide backloading clip is
unlikely to be necessary.
4. Backload the wire guide through the dilator tip as shown in Fig. 1 (for soft wires) or Fig. 2 (for stiff wires).
Ensure the wire guide exits out of the skive and runs parallel to the sheath. Once the wire guide is successfully
backloaded, remove the wire guide backloading clip (if used) as shown in Fig. 3.
5. 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.
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. Confirm the dilator/sheath assembly is properly placed via fluoroscopy.
7. While holding the Flexor sheath in position, unlock the fitting and remove the dilator in one slow, continuous
pull. (Fig. 4) Removal of the dilator will release the wire guide via the slit on the distal tip. The wire guide will
remain outside the working channel to maintain access. (Fig. 5)
8. Introduce the desired instrument as needed.
9. Suture may be utilized to secure the adapter externally. Suture holes are 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 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 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.
PŘÍSTUPOVÝ URETERÁLNÍ SHEATH FLEXOR® PARALLEL™ RAPID RELEASE™
POZOR: Federální zákony USA dovolují prodej tohoto prostředku pouze lékařům nebo na předpis lékaře (nebo
kvalifikovaného zdravotníka s licencí).
POPIS ZAŘÍZENÍ
• Přístupový ureterální sheath a zkosený dilatátor s aretačním ústím (Pro snazší umístění je sestava dilatátor/sheath
opatřena hydrofilním povlakem AQ®.)
• Svorka pro zakládání vodicího drátu technikou „backload"
POZNÁMKA: Komponenty soupravy se mohou lišit.
URČENÉ POUŽITÍ
Toto zařízení se používá k vytvoření traktu při endoskopických urologických výkonech pro usnadnění průchodu
endoskopů a jiných nástrojů do močového ústrojí.
KONTRAINDIKACE
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VAROVÁNÍ
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