COOK Medical Universa Mode D'emploi page 3

apply to individual patients. Informed consent should be obtained to
maximize patient compliance with follow-up procedures.
U.S. Federal Law restricts this device to sale by or on the order of a
physician.
SUGGESTED INSTRUCTIONS FOR ACTIVATING HYDROPHILIC COATING
The hydrophilic coating on this wire guide is activated by immersion in sterile
water or sterile saline solution. Note: Hydrophilic coated wire guides are
intended for one-time use.
SUGGESTED INSTRUCTIONS FOR USE
1. Prior to using the wire guide, fill a 10 ml syringe with sterile water or sterile
saline solution and attach it to the flushing port on the wire guide holder.
2. Inject sterile liquid into the holder until it is full and liquid can be seen exiting
around the tip of the wire guide. Note: Hydrophilic coating is not permanent. If
after extended use the coated wire guide does not perform smoothly, replace
the wire guide with a new coated guide.
ASSEMBLY FOR STENT INSERTER AND RELEASE SLEEVE
CAUTION: It is imperative the filiform flexible end of the wire guide is
introduced into the ureter first.
1. 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.
2. Place the stent inserter inside the release sleeve and secure the Luer lock
fitting.
3. Introduce the flexible end of the wire guide into the fitting end of the stent
inserter and advance it until the flexible end of the wire guide extends half
its length beyond the end of the inserter/release sleeve assembly. Note: The
lockable fitting on the distal end of the stent inserter must be loosened to allow
the wire guide to be introduced.
4. Carefully introduce the flexible end of the wire guide into the blunt end of
the stent and advance it until the stent is straightened and the flexible tip of the
wire guide extends beyond the tapered end of the stent.
5. While maintaining the position of the stent and the wire guide, advance the
inserter/release sleeve assembly to the blunt end of the stent. Push the tip of
the stent inserter into the end of the stent. Note: The stent is pushed until it
reaches the ink mark on the release sleeve.
6. Check to ensure the flexible tip of the wire guide extends beyond the tip
of the straightened stent and then tighten the lockable fitting to secure the
position of the stent inserter on the wire guide.
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