ZOLL Cool Line CL-2295AE/8700-0781-40 Instructions For Use Manual page 5

4. Similarly, check the tubing that returns to the pump from the
patient. Examine the saline bag to ensure that it has not been
accidentally compromised (for example, the spike may have
damaged the bag wall).
5. Trace the tubing from the saline bag back to the pump.
Additional warnings and cautions are located in the following instruc-
tions.
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1 Cool Line Catheter Kit for percutaneous introduction
1 500 cc bag of sterile normal saline (not provided)
Start-Up Kit (provided separately)
1 • 6 ft (183 cm) standard tubing or
• 9 ft (274 cm) extended tubing
Coolgard 3000 or Thermogard XP console (provided sep-
1
arately)
1 Catheter Convenience Kit [For (CO) only]
1 YSI-400 temperature probe (not provided)
`~íÜÉíÉê=éêÉé~ê~íáçå=~åÇ=áåëÉêíáçå
kçíÉK=The catheter has a radiopaque marker band to assist in identifica-
tion of the catheter during and after insertion when viewed using x-ray
equipment. The proximal end of the proximal balloon has one marker
band. The tip of the catheter contains barium sulfate to make it radi-
opaque. The proximal port is located 3.5 cm proximal to the proximal
marker band.
rëÉ=ëíÉêáäÉ=íÉÅÜåáèìÉK
`~ìíáçåK=Use femoral vein approach only.
`~ìíáçåK=The IN and OUT Luer-Locks on this catheter are custom-manu-
factured and are intended to connect only with the Start Up Kit listed in
Materials required.
1. Place the patient in a slight Trendelenburg position as tolerated to
reduce the risk of air embolism. If the femoral approach is used,
place the patient in a supine position.
2. Prep and drape the puncture site as required.
3. Carefully remove the catheter from the package, leaving on the
catheter membrane cover.
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1. Remove the caps from the IN and OUT Luers. With the catheter
cover in place, fill the syringe (5 cc or larger) with sterile saline and
attach the syringe to the female IN Luer.
t^okfkdK=Never inject positive pressure into the IN Luer with the
OUT Luer cap in place.
2. Gently inject saline through the catheter until it begins to exit
from the OUT Luer.
3. Using a 5 cc or larger syringe, flush the distal, proximal, and
medial infusion Luers with sterile saline. Clamp or attach the
injection caps to the proximal and medial infusion Luers. Leave the
distal Luer uncapped for guidewire passage.
`~ìíáçåK=Always prime the catheter infusion Luers before inserting
the catheter into the patient.
4. Remove the catheter membrane cover. If there is resistance in
removing the membrane cover from the catheter, flush the
membrane cover with sterile saline. Inspect the catheter to ensure
that air has been purged from the heat exchange membrane.
Inspect the catheter for leaks.
`~ìíáçåK=Avoid excessive wiping of the coated catheter. Avoid
wiping the catheter with dry gauze, as this may damage the cath-
eter coating. Avoid using alcohol, antiseptic solutions, or other
solvents to pre-treat the catheter, because this may cause unpre-
dictable changes in the coating, which could affect the device
safety and performance.
t^okfkdK=Do not cut the catheter to alter length.
fåëÉêíáåÖ=íÜÉ=Å~íÜÉíÉê
1. Obtain femoral venous access using standard percutaneous tech-
niques. Access should be maintained with a 0.032" (0.81 mm)
guidewire. See Guidewire Instructions for Use.
t^okfkdK=Do not attempt to reinsert a partially or completely
withdrawn OTN (over the needle) introducer needle from its cath-
eter.
`~ìíáçåK=Do not use a guidewire larger than 0.032" (0.81 mm)
with the catheter.
2. Holding the guidewire in place, remove the introducer catheter.
`~ìíáçåK=Maintain a firm grip on the guidewire at all times.
3. Enlarge the cutaneous puncture site with the cutting edge of the
scalpel positioned away from the guidewire. t^okfkdK=aç=åçí=
Åìí=íÜÉ=ÖìáÇÉïáêÉK Use a vessel dilator to enlarge the site as
required. Do not leave the vessel dilator in place as an indwelling
catheter, to minimize the risk of a possible vessel wall perforation.
4. Thread the tip of the catheter over the guidewire. Maintain a
sufficiently firm grip on the guidewire during catheter insertion.
Grasping the catheter tip near the skin, advance the catheter into
the vein. Continue to advance the catheter over the guidewire,
placing your fingers just proximal to the balloon.
5. Using centimeter marks on the catheter as positioning reference
points, advance the catheter to at least the 18 cm mark, to ensure
the proximal infusion port is in the vessel.
6. Hold the catheter at the desired depth and remove the guidewire.
If resistance is encountered when attempting to remove the
guidewire after catheter placement, the guidewire may be kinked
at the tip of the catheter. If resistance is encountered, withdraw
the catheter relative to the guidewire about 2–3 cm and attempt
to remove the guidewire. If resistance is encountered again,
remove the guidewire and catheter simultaneously.
`~ìíáçåK=Do not apply undue force to the guidewire.
7. Verify that the guidewire is intact upon removal.
8. Check catheter placement by attaching a syringe to the distal
infusion Luer and aspirate until a free flow of venous blood is
observed. Connect the infusion Luers to the appropriate Luer-Lock
line(s) as required. Unused infusion port(s) may be "locked"
through the injection cap(s) using standard hospital protocol. Slide
clamps are provided on the tubing to occlude flow through the
infusion Luers during line and injection cap changes.
`~ìíáçåK=To minimize risk of damage to the tubing from excessive
pressure, the clamp must be opened prior to infusing through the
Luer.
`~ìíáçåK=Do not clamp or occlude IN or OUT lines. This can cause
line blockage and possible failure.
9. Secure and dress the insertion site and catheter temporarily.
10. If subclavian or jugular access is used, verify the catheter tip
position by chest x-ray immediately after placement. The x-ray
examination must show the catheter located in the right side of
the mediastinum in the SVC with the distal end of the catheter
parallel to the vena cava wall. The catheter distal tip must be
positioned at a level above either the azygos vein or the carina of
the trachea, whichever is better visualized. If the catheter tip is
malpositioned, reposition and reverify. If femoral access is used,
x-ray examination must show the catheter located in the IVC with
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