Cool Line
®
Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
CL-2295A/8700-0781-01
4 of 10
ZOLL
6.
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 with a slight twisting motion.
Continue to advance the catheter over the guidewire,
placing your fingers just proximal to the balloon.
7.
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.
8.
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.
9.
Caution: Do not apply undue force to the guidewire.
10.
Verify that the guidewire is intact upon removal.
11.
Check catheter placement by attaching a syringe to the
distal and proximal infusion Luers and aspirate until a free
flow of venous blood is observed. Connect infusion Luers
to appropriate Luer-Lock line(s) as required. Unused
infusion port(s) may be “locked” through 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.
Caution
: To minimize risk of damage to the tubing from
excessive pressure, each clamp must be opened prior to
infusing through that Luer.
12.
Caution: Do not clamp or occlude the IN or OUT lines.
This can cause line blockage and possible failure
.
13.
Secure and dress the insertion site and catheter
temporarily.
14.
If subclavian or jugular access is used, verify the catheter
tip position by chest x-ray immediately after placement.
The x-ray exam 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.
15.
If femoral access is used, x-ray examination must show
the catheter located in the IVC with the distal end of the
catheter parallel to the vena cava wall. If the catheter tip is
malpositioned, reposition and reverify.
16.
The proximal radiopaque marker indicates the proximal
end of the balloon. Ensure that the balloon and proximal
port reside completely in the vessel. If the catheter is
malpositioned, reposition and reverify.
17.
Secure the catheter to the patient. Use the juncture Luer
side wings as the primary suture site to minimize the risk
of catheter migration.
18.
The ZOLL suture tab and clip can also be used as an
additional attachment point. Ensure that the catheter body
is secure and does not slide.
19.
Caution: Use only the ZOLL suture tab and clip
provided in the kit. Catheter damage may result if
other tabs or clips are used.
20.
Caution: Do not suture directly to the outside diameter
of the catheter to minimize the risk of cutting or
damaging the catheter or impeding catheter flow.
21.
Dress the puncture site per hospital protocol. Maintain
the insertion site with regular meticulous redressing using
aseptic technique.
22.
Record on the patient's chart the indwelling catheter
length using the centimeter marks on the catheter shaft as
reference. Frequent visual reassessment should be made
to ensure that the catheter has not moved.
23.
Attach a primed Start-Up Kit to the catheter by
connecting the male Luer of the Start-Up Kit to the
female IN Luer of the catheter (labeled “IN”) and the
female Luer of the Start-Up Kit to the male OUT Luer of
the catheter (labeled “OUT”). White "ZOLL" tags are
fitted loosely to the IN and OUT extension tubes to help
identify them.
24.
The Start-Up Kit IN and OUT Luers are only intended to
connect to the catheter IN and OUT Luers and are not
intended to connect to standard Luer Lock syringes.
They have ZOLL custom fittings and are orange in color
for easy identification.
25.
Ensure that a sufficient amount of sterile saline is present
at the ends of the Luers to make an air-free connection.
Refer to the operation manual.
26.
Warning: Failure to connect the Start-Up Kit
correctly to the catheter could result in catheter
failure. Do not attach the Start-Up Kit (orange) Luers
to the dark blue, white or brown infusion Luers.
27.
Caution: Do not place any stopcocks in line that may
be inadvertently shut off. This can cause line blockage
and possible failure.
28.
Pump saline through the Start-Up Kit and catheter to
ensure that all connections are secure and that there is no
leaking. Allow any remaining air in the system to be
purged out.
Disconnecting the Catheter from the System
1.
Stop circulation of saline through the catheter.
2.
Disconnect the Start-Up Kit from the catheter.
3.
To maintain sterile connections, immediately cap off the
Luer connectors of both the catheter and Start-Up Kit
using sterile Luer caps or connect the IN and OUT Luers
together.
Reconnecting the Catheter to the System
1.
Remove the Luer caps from the Luer connectors of the
catheter and Start-Up Kit. Discard the Luer caps or
disconnect IN and OUT Luers from each other.
2.
Attach the Start-Up Kit to the catheter by connecting the
male Luer of the Start-Up Kit to the female IN Luer of
the catheter and the female Luer of the Start-Up Kit to
the male OUT Luer of the catheter. The Start-Up Kit and
catheter IN and OUT Luers are orange in color. Ensure
that a sufficient amount of sterile saline is present at the
ends of the Luers to make an air-free connection.
Warning: Failure to connect the Start-Up Kit
correctly to the catheter could result in catheter
failure.
3.
Warning: DO NOT confuse the IN and OUT Luer
fittings for standard central line infusion ports. They
are for connection to the Coolgard 3000/Thermogard
XP System ONLY.
