ZOLL IVTM Catheter Quattro - Manual (Page 2)

Quattro
®
Catheter
Instructions for Use
Model IC4593/8700-0660-01
2 of 11
106083-001 Rev 2
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 dysrhythmia.
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 Quattro
® 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. 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
closed loop. With any fluid loss alarm, check both the
integrity of the catheter and the Start-Up Kit (see below).