ZOLL Quattro IC-4593AE/8700-0660-40 Mode D'emploi page 3

states. Care should be taken to properly monitor
patient homeostasis during hypothermia.

Cardiac rhythm disturbances – both
bradycardia and ventricular
tachyarrhythmia.

Clotting and coagulations function.
Patients at risk for disturbances of their
clotting or coagulation function should be
closely monitored during hypothermia.

Blood gas and pH analysis. Hypothermia
modifies resting pH and PaCO
Physicians should be aware of the effect
of temperature upon the result.

Prolonged hypothermia depresses the
immune response and lung function.
WARNING: INTRALUMINAL LEAKAGE
Intraluminal leakage between the saline lumen and
infusion lumens is an uncommon but potential catheter
failure. In the event of such a failure, sterile saline from
the cooling circuit will be introduced into the patient.
Intraluminal leakage will usually be associated with a
fluid loss alarm which will stop the system. ALWAYS
INVESTIGATE FLUID LEVEL ALARMS. The
cooling circuit is a closed loop system – usually fluid
loss alarms indicate a breach somewhere in this closed
loop. With any fluid loss alarm, check both the
integrity of the catheter and the Start-Up Kit
(see below).
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
and properly cap both the catheter and Start-Up
Kit using an aseptic technique.
3. Fill a sterile 10 ml syringe with sterile saline.
4. Connected to the INFLOW lumen of the catheter
and disconnect the outflow cap. Infuse the 10 ml
of saline – it should flow out the outflow lumen.
5. Now cap the OUTFLOW lumen and pull 5 cc of
vacuum and sustain this 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 INFLOW lumen.
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).
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.
106142-001
IC-4593AE/8700-0660-40 & IC-4593CO/8700-0624-40
Materials Required:
Quantity Description
1 Quattro Kit for percutaneous introduction
1 Bag of normal saline
1 Start-Up Kit
1 CoolGard 3000
1 Catheter Convenience Kit
(For (CO) only)
.
2
Catheter Preparation and Insertion:
Use sterile technique.
1. Caution: Use femoral vein approach only.
2. Place patient in a supine position.
3. Prep and drape puncture site as required.
4. Caution: Always prime catheter before it is
inserted into patient.
5. Carefully remove catheter from package, leaving
on catheter membrane cover.
Catheter Preparation Procedure:
1. Remove caps from the inflow and outflow luer
hubs. With the catheter cover in place, fill
syringe (5cc or larger) with sterile saline and
attach syringe to female inflow luer hub.
2. Warning: Never inject positive pressure into
the inflow hub with the outflow luer cap in
place.
3. Gently inject saline through catheter until it
®
/
begins to exit from outflow luer.
4. Using 5 cc or larger syringe, flush the distal
infusion lumen with sterile saline. Leave the
distal luer uncapped for guidewire passage.
5. Remove catheter membrane cover. If there is
resistance in removing the membrane cover
from the catheter, flush the membrane cover
with sterile saline. Inspect catheter to assure
that air has been purged from the heat exchange
membrane. Inspect the catheter for leaks.
6. Warning: Do not cut the catheter to alter length.
Catheter Insertion:
1. Obtain femoral venous access using standard
percutaneous techniques. Access should be
maintained with a 0.032" (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
0.032" (0.81mm) with the Quattro Catheter.
4. Holding spring guidewire in place, remove
introducer catheter. Precaution: Maintain a firm
grip on the guidewire at all times.
5. Enlarge the cutaneous puncture site with cutting
edge of scalpel positioned away from the guidewire.
Warning: Do not cut guidewire. Use vessel dilator
to enlarge site as required. Do not leave vessel
dilator in place as an indwelling catheter to minimize
risk of possible vessel wall perforation
6. Thread tip of Quattro Catheter over guidewire.
Maintain a sufficiently firm grip on the
guidewire during catheter insertion. Grasping
near skin, advance catheter into vein with a
slight twisting motion.
7. Using centimeter marks on the catheter as
positioning reference points, advance catheter
to final indwelling position.
8. Hold catheter at desired depth and remove
guidewire. If resistance is encountered when
attempting to remove the guidewire after catheter
placement, the guidewire may be kinked about 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 again encountered
remove the guidewire and catheter simultaneously.
® ®
/Thermogard XP System
Revision 7
ZOLL
9. Caution: Do not apply undue force to the
guidewire.
10. Verify that the guidewire is intact upon removal.
11. Check lumen placement by attaching a syringe
to the distal infusion luer hub and aspirate until
a free flow of venous blood is observed. Connect
infusion luer to appropriate Luer-Lock line as
required. Unused infusion port may be "locked"
through injection cap using standard hospital
protocol. A slide clamp is provided on the tubing
to occlude flow through the infusion lumen
during line and injection cap changes.
Precaution: To minimize risk of damage to the
tubing from excessive pressure, the clamp must
be opened prior to infusing through the lumen.
12. Caution: Do not clamp or occlude inflow or
outflow lines. This can cause line blockage
and possible failure.
13. Secure and dress catheter temporarily.
14. Verify catheter tip position by chest x-ray
immediately after placement. 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 reverify.
15. Proximal radiopaque marker indicates proximal
end of balloons to ensure that balloons reside
completely in vessel. If catheter is
malpositioned, reposition and reverify.
16. Secure catheter to patient. Use juncture hub side
wings as primary suture site.
17. The ZOLL suture tab and clip can also be used
as an additional attachment point. Assure that
catheter body is secure and does not slide.
18. Caution: Use only the ZOLL suture tab and
clip provided in the kit. Catheter damage may
result if other tabs or clips are used.
19. 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.
20. Maintain the insertion site with regular
meticulous redressing using aseptic technique.
21. 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.
22. Attach a primed Start-Up Kit to Quattro Heat
Exchange Catheter by connecting the male luer
of the Start-Up Kit to the female inflow luer of
the Quattro Catheter and the female luer of the
Start-Up Kit to the male outflow luer of the
Quattro Catheter. White "ZOLL" tags are fitted
loosely to the INFLOW and OUTFLOW
extension tubes to help identify them. Assure
that a sufficient amount of sterile saline is
present at the ends of the hubs to make an air
free connection.
®
Refer to CoolGard 3000 /Thermogard XP
manual for details on CoolGard 3000
®
Thermogard XP operation.
23. Warning: Failure to connect the Start-Up Kit
correctly to the catheter could result in
catheter failure. Do not attach Start-Up Kit to
the brown luer.
24. Caution: Do not attach Start-Up Kit to
distal port.
25. Caution: Do not place any stopcocks in line
that may be inadvertently shut off. This can
cause line blockage and possible failure.
26. Pump saline through Start-Up Kit and catheter to
assure that all connections are secure and that
there is no leaking. Allow any remaining air in
system to be purged out.
Disconnecting Catheter from CoolGard
® ®
3000 /Thermogard XP System:
1. Stop circulation of saline through catheter.
2. Disconnect Start-Up Kit from catheter.
3 of 76
®
®
/