English (En) - ZOLL Cool Line CL-2295AE/8700-0781-40 Instructions For Use Manual

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Cool Line Intravascular Heat Exchange Catheter Kit includes:
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Cool Line intravascular heat exchange catheter
9.3 French x 22 cm
Triple infusion Luer
1 AE(CO)
Extension line clamps
Radiopaque shaft
Applause heparin coated
1 AE(CO) Guidewire 0.032" (0.81 mm) x 65 cm
Vessel dilator 10 F x 0.038"
1 AE(CO)
(3.4 mm x 1.0 mm)
1 AE(CO) Detachable suture tab & clip
18 ga x 2½" (1.3 mm x 63 mm) Radiopaque
1 AE
OTN catheter
5 cc Syringe & 22 ga x 1½" (0.7 mm x 38 mm)
1 AE
Needle
1 AE Fenestrated drape
1 AE 18 ga x 2¾" (1.3 mm x 70 mm) Needle
6 AE 4" x 4" (10 cm x 10 cm) Gauze sponges
1 AE 000 Silk suture
1 AE No. 11 Surgical blade with long handle
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Each base model is available either with a standard supporting insertion
kit (AE) or without the standard supporting insertion kit (CO). The com-
ponents common to both kits are labeled AE(CO) in the table above.
The additional components found only in the standard kit are labeled
AE.
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The Cool Line intravascular heat exchange catheter is a sterile, single
use flexible 9.3 F catheter designed for placement in the central venous
circulation from an insertion site in the jugular, subclavian, or femoral
veins. The catheter is to be connected to a ZOLL
Start-Up Kit and the Coolgard 3000
supplied separately). A dilator and guidewire are required for the percu-
taneous insertion of the catheter.
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Proximal port (blue)
Medial port (white)
Guidewire port (brown)
:
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CL-2995AE(CO) 9.3 F
The catheter blood contact surfaces (tip, balloon, and shaft) are treated
with an anti-thrombotic Applause heparin coating.
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Ethylene oxide sterilized. The catheter is supplied sterile for single use
only and should not be resterilized. The package should be inspected
prior to use to ensure that the sterility barrier has not been compro-
mised.
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single use disposable
® ®
/Thermogard XP console (both
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1400 ml/hr
1200 ml/hr
2100 ml/hr
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Store in a cool, dry place.
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The Cool Line catheter in combination with the Coolgard 3000 or
Thermogard XP System permits circulation of temperature controlled
saline through a heat exchanger to cool/rewarm the patient's blood in
patients for whom the risks of a central line are warranted. Maximum
use period: 7 days.
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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 a vascular system that will not
accommodate a catheter.
6. Patients for whom the required temperature monitoring cannot
be established.
7. Hypothermia is contraindicated in patients who have
hematological diseases that will be made worse with hypothermia
(e.g., any disease that produces cryoglobulinemia, any
hemoglobinopathy in which hemolytic anemia can be precipitated
by cold including Sickle Cell Disease or Thalassemia).
8. Not intended for pediatric or neonatal use.
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Central venous catheterization should only be performed by well-
trained personnel well-versed in anatomical landmarks and safe tech-
nique. Personnel should also have knowledge of potential complica-
tions.
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The catheter should be placed via a jugular, subclavian, or
femoral vein approach only. Do not allow the catheter to be
placed into the right atrium or right ventricle. Placement in
the right atrium or right ventricle can result in severe patient
injury or death.
páåÖäÉ=ìëÉ=çåäóK Product designed for single use only. Do not resterilize
or reuse. Do not reinsert, once removed from the patient. Do not alter
the catheter in any way.
Potential risks with re-use of a single use device include but are not lim-
ited to:
• Potentially life threatening infection
• Toxic shock due to degradation of materials
• Increased risk of thrombosis
• Reduced heat exchange power
• Device failures
1. The catheter should be positioned so that the distal tip of the
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 posi-
tioned at a level above either the azygos vein or the carina of the
trachea, whichever is better visualized.
2. 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.
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