ZOLL IVTM Catheter Icy - Manual (Page 3)

Icy
®
Catheter
Instructions for Use
Model IC-3893A/8700-0657-01 (Also referred to as IC-3893)
3 of 11 106085-001 Rev.2
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 tubing set:
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 Icy ® 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 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 .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 Icy
® 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 Icy ® 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.
10. Verify that the guidewire is intact upon removal.