ZOLL IVTM Catheter Cool Line - Manual (Page 2)

Cool Line
®
Catheter
Instructions for Use
CL-2295A/8700-0654-01 (Also referred to as CL-2295)
2 of 11 106084-001 Rev.2
Contraindications:
1. The risks of the catheter are essentially those of a
central line. The catheter should not be used in patients
for whom central line placement is not indicated.
2. Bleeding diathesis.
3. Active sepsis.
4. Infection or active bleeding at the site of catheter
insertion.
5. Patients with no vascular access, or vascular system
will not accommodate catheter.
6. Patients for whom the required temperature monitoring
cannot be established.
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: 7 days.
2. The use of intravascular cooling devices controls fever,
including fever due to sepsis. Care must be taken to
assess patients for sepsis.
3. 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.
4. Use of a syringe smaller than 10 ml to irrigate or declot
an occluded catheter may cause intraluminal leakage or
catheter rupture.
5. Caution: If blood is observed within the circuit
circulating the sterile saline, stop the procedure.
6. The catheter is coated with Heparin. This may induce
or aggravate pre-existing Heparin induced
thrombocytopenia (HIT).
7. 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.
8. Catheter should be placed via a jugular, subclavian, or
femoral vein approach only.
9. Do not allow catheter to be placed into right atrium or
right ventricle. If placed via the jugular or subclavian
veins, catheter should be positioned so that the distal
tip of catheter is in the superior vena cava above 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. The
distal tip of the catheter should be positioned at a level
above either the azygos vein or the carina of the
trachea, whichever is better visualized.
10. If placed via the femoral vein, the 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.
11. 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.
12. All Luer-Lock connections and covers must be
securely tightened to prevent air embolism or fluid
or blood loss.
13. 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.
14. Passage of the guidewire into the right heart can
cause dysrhythmias, right bundle branch block,
vessel wall, atrial or ventricular perforation.
15. Use only sterile normal saline for catheter priming
and as the circulating fluid in the catheter.
16. 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.
17. 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.
18. For blood sampling, temporarily shut off remaining
infusion
19. Use only a 30cc or smaller syringe for blood
sampling.
ports through which solutions are being
infused.
20. 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 Cool Line
®
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.
21. Do not infuse into the teal-green Luer-Lock
connections.
22. Use only the ZOLL suture tab and clip provided in
kit to prevent catheter damage.
23. Not intended for pediatric or neonatal use.
24. 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.
25. When connecting infusion sets/injection systems to
ZOLL Catheters do not exceed 100 psi/689 kPa.
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