ZOLL IVTM Catheter Icy - Manual (Page 2)

Icy
®
Catheter
Instructions for Use
Model IC-3893A/8700-0657-01 (Also referred to as IC-3893)
2 of 11 106085-001 Rev.2
can be precipitated by cold including Sickle Cell
Disease or Thalassemia.
Warnings and Precautions:
1. SINGLE USE ONLY. Product designed for single use
only. Do not resterilize or reuse. Do not reinsert, once
removed from patient. Do not alter the catheter in any
way. Maximum use period: 4 days.
2. Do not allow catheter to be placed into right atrium or
right ventricle. Catheter should be positioned so that
the distal tip of catheter is in the inferior vena cava
below its junction with the right atrium and parallel to
the vessel wall. X-ray examination should be used to
ensure that the catheter is not in the right atrium or
ventricle.
3. Cardiac Tamponade: Placement of indwelling catheters
in the right atrium is a practice that may lead to cardiac
perforation and tamponade. Practitioners placing
central venous catheters must be aware of this
potentially fatal complication before advancing the
catheter too far relative to patient size. The actual
position of the tip of the indwelling catheter should be
confirmed by x-ray after insertion. Central venous
catheters should not be placed in the right atrium unless
specifically required for special relatively short term
procedures, such as aspiration of air emboli during
neurosurgery. Such procedures are nevertheless risk
prone and should be closely monitored and controlled.
4. Alcohol and acetone can weaken the structure of the
polyurethane material. Care should therefore be taken
when infusing drugs containing alcohol or when using
alcohol or acetone when performing routine catheter
care and maintenance. Alcohol should not be used to
declot the catheter.
5. Use of a syringe smaller than 10 ml to irrigate or declot
an occluded catheter may cause intraluminal leakage or
catheter rupture.
6. Caution: If blood is observed within the circuit
circulating the sterile saline, stop the procedure.
7. The catheter is coated with Heparin. This may induce
or aggravate pre-existing Heparin induced
thrombocytopenia (HIT).
8. Central venous catheterization should only be
performed by well-trained personnel well versed in
anatomical landmarks and safe technique. Personnel
should also have knowledge of potential complications.
9. Catheter should be placed via a femoral vein approach
only.
10. Possible complications with central venous catheters
include: atrial or ventricular perforation, cardiac
tamponade, air embolism, catheter embolism, thoracic
duct laceration, bacteremia, septicemia, thrombosis,
inadvertent arterial puncture, hematoma formation,
hemorrhage, nerve damage and dysrhythmias.
11. All Luer-Lock connections and covers must be securely
tightened to prevent air embolism or fluid or blood loss.
12. Never use excessive force in moving the catheter or
guidewire. If resistance is encountered, an x-ray should
be performed to identify the reason for the resistance.
13. Passage of the guidewire into the right heart can cause
dysrhythmias, right bundle branch block, vessel wall,
atrial or ventricular perforation.
14. Use only sterile normal saline for catheter priming
and as the circulating fluid in the catheter.
15. Catheter should be routinely inspected for flow
rate, security of dressing, correct catheter position
and for secure Luer-Lock connection. Use
centimeter markings to identify if the catheter
position has changed.
16. Only x-ray examination can ensure that the
catheter tip has not entered the heart or no longer
lies parallel to the vessel wall. If catheter position
has changed, perform an x-ray examination to
confirm catheter tip position.
17. For blood sampling, temporarily shut off
remaining infusion ports through which solutions
are being infused.
18. Use only a 30cc or smaller syringe for blood
sampling.
19. Use only ZOLL suture tab and clip provided in kit
to prevent catheter damage.
20. Do not infuse into the teal-green Luer-Lock
connections.
21. Use care when infusing drugs that may be
affected by cool temperatures (as low as 4ºC).
Mannitol containing solutions are temperature
sensitive and must not be delivered through the
Icy
® Catheter except for rapid push of up to a
concentration of 20% mannitol solution followed
by saline flush. Higher than a 20% concentration
of mannitol or drip or infusion pump delivery of
mannitol must be done via a separate line.
22. WARNING: When connecting infusion
sets/injection systems to ZOLL Catheters do not
exceed 100 psi/689 kPa.
23. Not intended for pediatric or neonatal use.
24. For patients being made hypothermic, the
hypothermia itself may exacerbate some disease
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
2
. Physicians
should be aware that 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