Cool Line
®
Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
CL-2295A/8700-0781-01
3 of 10
ZOLL
To check the integrity of the catheter
1.
Stop operation of the Coolgard 3000/
Thermogard XP System.
2.
Disconnect the Start-Up Kit from the catheter. Properly
cap both the catheter and Start-Up Kit using an aseptic
technique.
3.
Fill a sterile 10 ml slip tip syringe with sterile saline.
4.
Connect the syringe to the IN Luer of the catheter and
disconnect the OUT cap. Infuse the 10 ml of saline– it
should flow out the OUT Luer.
5.
Cap the OUT Luer and pull 5 cc of vacuum. Sustain for at
least 10 seconds. Approximately 4 ml of saline, but not
blood, should enter the syringe and you should be able to
maintain the vacuum.
6.
Ease the vacuum and recap the IN Luer.
To check the integrity of the Start-Up Kit
1.
Look for obvious leakage.
2.
Remove the tubing from the pump raceway and inspect
for damage (return it to position if not damaged).
3.
Check along the tubing from the pump to the patient for
sources of fluid loss.
Look for damage to the tubing and/or the presence of
air within the tubing.
Inspect, and tighten as necessary, each Luer fitting
(do not use instruments to tighten Luer fittings).
Note: Condensation on the exterior of the tubing is
normal.
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.
More warnings and precautions are located in following
instructions.
Materials Required
Quantity Description
1
Cool Line
Kit for percutaneous introduction
1
500 cc bag of sterile normal saline
1
Coolgard 3000/Thermogard XP Start-Up Kit
(provided separately)
6 ft (183 cm) Standard Tubing or
9 ft (274 cm) Extended Tubing
1
Coolgard 3000/Thermogard XP
System
Catheter Preparation and Insertion
Note
: The catheter has a radiopaque marker band to assist in
identification 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 radiopaque.
Use sterile technique.
1.
Caution: Use jugular, subclavian, or femoral vein
approach only.
2.
Caution: The IN and OUT Luer-Locks on the catheter
are custom manufactured and are intended to connect
only with the ZOLL Start Up Kits listed in Materials
Required. They are not intended to connect to standard
Luer-Lock syringes or other standard Luer-Lock
connectors.
3.
Place the patient in a slight Trendelenburg position as
tolerated to reduce the risk of air embolism. If a femoral
approach is used, place the patient in a supine position.
4.
Prep and drape the puncture site as required.
5.
Caution: Always prime the catheter before it is
inserted into the patient.
6.
Carefully remove the catheter from the package, leaving
on the catheter membrane cover.
Catheter Preparation Procedure
1.
Remove the caps from the IN and OUT Luers. With the
catheter cover in place, fill a 5 cc or larger syringe with
sterile saline and attach the syringe to the female IN
Luer.
2.
Warning: Never inject positive pressure into the IN
Luer with the OUT Luer cap in place.
3.
Gently inject saline through the catheter until it begins to
exit from the OUT Luer.
4.
Using a 5 cc or larger syringe, flush the distal and
proximal infusion Luers with sterile saline. Clamp or
attach injection caps to the proximal infusion Luer.
Leave the distal Luer uncapped for guidewire passage.
5.
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.
6.
Caution: Avoid excessive wiping of the coated
catheter. Avoid wiping the catheter with dry gauze, as
this may damage the catheter coating. Avoid using
alcohol, antiseptic solutions, or other solvents to pre-
treat the catheter, because this may cause
unpredictable changes in the coating, which could
affect the device safety and performance.
7.
Warning: Do not cut the catheter to alter length.
Catheter Insertion
1.
Obtain jugular, subclavian, or femoral venous access
using standard percutaneous techniques. Access should
be maintained with a .032" (0.81 mm) guidewire. See
Special Instructions for Guidewires
.
2.
Warning: Do not attempt to re-insert a partially or
completely withdrawn OTN (over the needle)
introducer needle from its catheter.
3.
Caution: Do not use a guidewire larger than .032"
(0.81 mm) with the Cool Line catheter.
4.
Holding the guidewire in place, remove the introducer
catheter.
Caution: Maintain a firm grip on the
guidewire at all times.
5.
Enlarge the cutaneous puncture site with the cutting edge
of the scalpel positioned away from the guidewire.
Warning: Do not cut the guidewire.
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 vessel wall perforation
