ICY
®
Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
Model IC-3893A/8700-0782-01
4 of 10
11.
Using centimeter marks on the catheter as positioning
reference points, advance catheter to at least the 18 cm mark,
to ensure the proximal infusion port is in the vessel.
12.
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.
13.
Caution: Do not apply undue force to the guidewire.
14.
Verify that the guidewire is intact upon removal.
15.
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 Luer to the appropriate Luer-
Lock line as required. The unused infusion port may be
"locked" through the injection cap using standard hospital
protocol. A slide clamp is provided on the tubing to occlude
flow through the infusion Luer during line and injection cap
changes.
Caution: To minimize risk of damage to the
tubing from excessive pressure, the clamp must be opened
prior to infusing through the Luer.
16.
Caution: Do not clamp or occlude IN or OUT lines. This
can cause line blockage and possible failure.
17.
Secure and dress the insertion site and catheter temporarily.
18.
Verify the catheter tip position by chest x-ray immediately
after placement. The x-ray exam 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 re-verify.
19.
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 re-verify.
20.
Secure the catheter to the patient. Use the juncture Luer side
wings as the primary suture site to minimize the risk of
catheter migration.
21.
The ZOLL suture tab and clip can also be used as an
additional attachment point. Ensure that catheter body is
secure and does not slide.
22.
Caution: Use only the ZOLL suture tab and clip provided
in the kit. Catheter damage may result if other tabs or
clips are used.
23.
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.
24.
Dress the puncture site per hospital protocol. Maintain the
insertion site with regular meticulous redressing using aseptic
technique.
25.
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.
26.
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 and the female Luer of the Start-Up Kit to the
male OUT Luer of the the catheter. White "ZOLL" tags are
fitted loosely to the IN and OUT extension tubes to help
identify them. 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.
27.
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.
28.
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 brown,
white or blue infusion Luers.
29.
Caution: Do not place any stopcocks in line that may be
inadvertently shut off. This can cause line blockage and
possible failure.
30.
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 as
described in the system operation manual.
Disconnecting the Catheter from the System
1.
Stop circulating 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 Luer connectors of the catheter
and Start-Up Kit. Discard the Luer caps or disconnect the 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.
3.
WARNING: Failure to connect the Start-Up Kit
correctly to the catheter could result in catheter failure.
4.
WARNING: DO NOT use the IN and OUT Luer fittings
for standard central line infusion ports. They are for
connection to the Coolgard 3000/Thermogard XP System
ONLY.
5.
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.
6.
Caution: Do not place any extra stopcocks in line that
may be inadvertently shut off. This can cause line
blockage and possible failure.
