ZOLL IVTM Catheter Cool Line - Manual (Page 3)

Cool Line
®
Catheter
Instructions for Use
CL-2295A/8700-0654-01 (Also referred to as CL-2295)
3 of 11 106084-001 Rev.2
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. 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.
Materials Required:
Quantity Description
1 Cool Line ® Kit for percutaneous
introduction
1 Bag of Normal Saline
1 Start-Up Kit
1 CoolGard 3000 ® /Thermogard XP ® System
Catheter Preparation and Insertion:
Use sterile technique.
1. Caution: Use jugular, subclavian, or femoral vein
approach only.
2. Place patient in a slight Trendelenburg position as
tolerated to reduce the risk of air embolism. If femoral
approach is used, place patient in 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 and
proximal infusion lumens with sterile saline. Clamp
or attach injection caps to the proximal infusion
lumen. 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 jugular, subclavian, or femoral venous access
using standard percutaneous techniques. Access
should be maintained with a .032" 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" with the Cool Line
® 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 Cool Line ® 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.
9. Caution: Do not apply undue force to the
guidewire.