ZOLL IVTM Catheter Cool Line - Manual

Cool Line
®
Catheter
Instructions for Use
CL-2295A/8700-0654-01 (Also referred to as CL-2295)
1 of 11 106084-001 Rev.2
Caution: Federal law restricts this device to sale by or on
the order of a physician.
Model CL-2295A/8700-0654-01 (Also referred
to as CL-2295)
Includes:
1 Cool Line ® Catheter
9.3 French x 22cm
Tri Infusion Lumen
Extension Line Clamps
Radiopaque Polyurethane
Applause™ Coated
2 Guidewires (.032" x 65cm)
1 Vessel Dilator
1 Detachable Suture Tab & Clip
1 18ga x 2 ½" (6.4cm) Radiopaque PTFE OTN
Catheter
1 000 Silk Suture
1 25ga x 1" (2.5 cm ) Needle
1 Chloraprep ® Triple Swabstick Prep Pack
6 4" x 4" Gauze Sponges
1 No. 11 Surgical Blade w/ long handle
1 3cc Syringe
2 5cc Syringes
1 Fenestrated Drape
1 Povidone Ointment
2 22ga x 1 ½" (3.8 cm) Needles
1 18ga x 2 ¾" (7.0 cm) Needle
1 5 cc Ampule Lidocaine HCL 1%
1 Needle Disposal Cup
1 SilvaSorb ® Site Antimicrobial Dressing
1 Suresite ® Transparent Film Dressing
Device Description:
The Cool Line ® Heat Exchange Catheter is a sterile, single
use flexible catheter designed for placement in the central
venous circulation from an insertion site in the jugular,
subclavian, or femoral veins. The Cool Line
® Catheter is to
be connected to a single use disposable CoolGard
3000
® /Thermogard XP ® Start-Up Kit (supplied separately)
and the CoolGard 3000 ® /Thermogard XP ® System. A dilator
and guidewire are required for the percutaneous insertion of
the Cool Line
® Catheter. Three lumens are available for
infusion, measuring central venous pressure or sampling.
Size
Flow Rate Priming
Volume
Proximal Port
(blue) 18 Ga 1400 ml/hr 0.3 cc
Medial Port
(white)) 18 Ga 1200 ml/hr 0.3 cc
Guidewire Port
(brown) 16 Ga 2100 ml/hr 0.4 cc
Insertion size:
Model CL-2295 9.3F
The Cool Line ® Catheter blood contact surfaces are
Applause™ treated. Applause is a trademark of
SurModics, Inc., registered in the U.S. Patent and trademark
office.
Sterility
Ethylene oxide sterilized. The Cool Line ® 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
compromised.
Storage:
Store between 20-25°C. Avoid freezing and excessive
heat above 40°C.
United States Patent Nos.:
6,126,684 6,299,599 6,409,747
6,416,533 6,585,692 6,645,234
6,652,565
6,749,585 6,656,209 6,719,724
Other U.S. and foreign patents pending.
Indications for Use:
The Cool Line ® Catheter Model CL-2295A when used
with the ZOLL Thermal Regulation System is indicated
for use in fever reduction, as an adjunct to other
antipyretic therapy, in adult patients with cerebral
infarction and intracerebral hemorrhage who require
access to the central venous circulation and who are
intubated and sedated.
Safety and Efficacy Considerations:
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. 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.
Potential risks with re-use of a single use device include
but are not limited to:
•
Potentially life threatening infection
•
Toxic shock due to degradation of materials
•
Increased risk of thrombosis
•
Reduced heat exchange power
•
Device failures
Warning – Fever Reduction
The safety of this device has not been demonstrated for
fever reduction in patients presenting with subarachnoid
hemorrhage or primary traumatic brain injury. The safety
and effectiveness of this device was examined in a
randomized controlled trial of 296 patients. The mortality
results reported in this trial, for the four patient cohorts
enrolled, are presented in the table below (CI – cerebral
infarction, ICH – intracerebral hemorrhage, PTBI –
primary traumatic brain injury, SAH – subarachnoid
hemorrhage).
Mortality by Diagnosis (ITT analysis)
Cool Line Control
n N % n N % p*
CI 3 16 18.8 3 14 21.4 0.74
ICH 8 33 24.2 7 27 25.9 1.00
PTBI 10 44 22.7 4 38 10.5 0.24
SAH 13 61 21.3 7 63 11.1 0.15
*Fischer’s exact test
For more details on the clinical trial results please refer to
Physician’s Manual – “Normothermia for the Neuro-
critically Ill stroke patient” #101416-001.
Warning: Do not allow catheter to be placed into right
atrium or right ventricle. Placement in right atrium or
right ventricle can result in severe patient injury or death.