ZOLL Cool Line CL-2295A/8700-0781-01 User manual

Cool Line®Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
CL-2295A/8700-0781-01
106476-001 Revision 5 1 of 10
ZOLL
Caution: Federal law restricts this device to sale by or on
the order of a physician.
Model CL-2295A/8700-0781-01(Also referred to as CL-
2295) includes:
Quantity
Description
1
Cool Line® Catheter
9.3 French x 22 cm
Tri Infusion Luer
Extension Line Clamps
Radiopaque Shaft
Applause Heparin Coated
2
Guidewires .032" (0.81 mm) x 65 cm
1
Vessel Dilator 10.5F x 0.38”
(3.6 mm x 1.0 mm)
1
Detachable Suture Tab & Clip
1
18 ga x 2 ½" (1.3 mm x 6.4 cm) Radiopaque
PTFE OTN Catheter
Catheter
1
000 Silk Suture
1
Chloraprep® Triple Swabstick Prep Pack
6
4" x 4" (10 cm x 10 cm) Gauze Sponges
1
No. 11 Surgical Blade w/ long handle
1
3 cc Syringe and 25 ga x 1" (0.5 mm x 2.5 cm)
Needle
2
5 cc Syringes and 22 ga x 1 ½” (0.7 mm x
38 mm) Needles
1
Fenestrated Drape
1
18 ga x 2 ¾" (1.3 mm x 67 mm) Needle
1
Needle Disposal Cup
1
SilvaSorb® Site Antimicrobial Dressing
1
Suresite® Transparent Film Dressing
Device Description
The Cool Line Intravascular Heat Exchange Catheter (“Cool
Line Catheter” or “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 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 Luers are available for infusion, measuring
central venous pressure or sampling.
Infusion Port
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 (tip, balloon, and
shaft) are treated with an anti-thrombotic Applause heparin
coating.
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.
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. The product is 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 reuse 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: 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.
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 a vascular system
will not accommodate a catheter. Patients for whom the
required temperature monitoring cannot be established.
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, refer to
the Physician’s Manual –“Normothermia for the
Neuro- critically Ill stroke patient”.

Cool Line®Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
CL-2295A/8700-0781-01
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ZOLL
6.
Warnings and Precautions
WARNING: The catheter and Start-Up Kit could
potentially misconnect with other devices with small bore
connectors. Such misconnection errors could result in
patient injury or death.
CAUTION: The custom Luers on the catheter and SUK
may reduce the risk of misconnections but still have the
potential for misconnections with these specific medical
device applications: Breathing Systems & Driving Gases
applications, Enteral & Gastric applications, Urethral &
Urinary applications, Limb Cuff Inflation applications,
Neuraxial applications, and Intravascular or Hypodermic
applications. Always use caution when connecting ZOLL
catheters and SUK’s to these and other medical device
applications.
CAUTION: Ensure that the catheter and/or Start-Up Kit
are not connected to an IV or other medical device.
1. SINGLE USE ONLY. The product is 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. 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 shaft
material. Care should thereforebetaken when infusingdrugs
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 sterile saline
circuit, 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. The catheter should be placed via a jugular, subclavian, or
femoral vein approach only.
9. Do not allow the catheter to be placed into the right atrium
or right ventricle. If placed via the jugular or subclavian
veins, 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 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 its distal tip 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. It is
the circulating fluid in the catheter.
16. The catheter should be routinely inspected for flow rate,
security of dressing, correct catheter position and for
secure Luer-Lock connections. Use the 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 the catheter position has changed, perform
an x-ray examination to confirm catheter tip position.
18. For blood sampling, temporarily shut off remaining
infusion ports through which solutions are being infused.
19. Use only a 30 cc or smaller syringe for blood sampling.
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 catheter except for a 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 orange Luer-Lock connections.
22. Use only the ZOLL suture tab and clip provided in the 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 Luer and infusion Luers 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).

Cool Line®Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
CL-2295A/8700-0781-01
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ZOLL
To check the integrity of the catheter
1. Stop operation of the Coolgard 3000/
Thermogard XP System.
2. Disconnect the Start-Up Kit from the catheter. Properly
cap both the catheter and Start-Up Kit using an aseptic
technique.
3. Fill a sterile 10 ml slip tip syringe with sterile saline.
4. Connect the syringe to the IN Luer of the catheter and
disconnect the OUT cap. Infuse the 10 ml of saline–it
should flow out the OUT Luer.
5. Cap the OUT Luer and pull 5 cc of vacuum. Sustain for at
least 10 seconds. Approximately 4 ml of saline, but not
blood, should enter the syringe and you should be able to
maintain the vacuum.
6. Ease the vacuum and recap the IN Luer.
To check the integrity of the Start-Up Kit
1. Look for obvious leakage.
2. Remove the tubing from the pump raceway and inspect
for damage (return it to position if not damaged).
3. Check along the tubing from the pump to the patient for
sources of fluid loss.
Look for damage to the tubing and/or the presence of
air within the tubing.
Inspect, and tighten as necessary, each Luer fitting
(do not use instruments to tighten Luer fittings).
Note: Condensation on the exterior of the tubing is
normal.
4. Similarly, check the tubing that returns to the pump from
the patient. Examine the saline bag to ensure that it has not
been accidentally compromised (for example, the spike
may have damaged the bag wall).
5. Trace the tubing from the saline bag back to the pump.
More warnings and precautions are located in following
instructions.
Materials Required
Quantity Description
1 Cool Line Kit for percutaneous introduction
1 500 cc bag of sterile normal saline
1 Coolgard 3000/Thermogard XP Start-Up Kit
(provided separately)
6 ft (183 cm) Standard Tubing or
9 ft (274 cm) Extended Tubing
1 Coolgard 3000/Thermogard XP System
Catheter Preparation and Insertion
Note: The catheter has a radiopaque marker band to assist in
identification of the catheter during and after insertion when
viewed using x-ray equipment. The proximal end of the
proximal balloon has one marker band. The tip of the catheter
contains barium sulfate to make it radiopaque.
Use sterile technique.
1. Caution: Use jugular, subclavian, or femoral vein
approach only.
2. Caution: The IN and OUT Luer-Locks on the catheter
are custom manufactured and are intended to connect
only with the ZOLL Start Up Kits listed in Materials
Required. They are not intended to connect to standard
Luer-Lock syringes or other standard Luer-Lock
connectors.
3. Place the patient in a slight Trendelenburg position as
tolerated to reduce the risk of air embolism. If a femoral
approach is used, place the patient in a supine position.
4. Prep and drape the puncture site as required.
5. Caution: Always prime the catheter before it is
inserted into the patient.
6. Carefully remove the catheter from the package, leaving
on the catheter membrane cover.
Catheter Preparation Procedure
1. Remove the caps from the IN and OUT Luers. With the
catheter cover in place, fill a 5 cc or larger syringe with
sterile saline and attach the syringe to the female IN
Luer.
2. Warning: Never inject positive pressure into the IN
Luer with the OUT Luer cap in place.
3. Gently inject saline through the catheter until it begins to
exit from the OUT Luer.
4. Using a 5 cc or larger syringe, flush the distal and
proximal infusion Luers with sterile saline. Clamp or
attach injection caps to the proximal infusion Luer.
Leave the distal Luer uncapped for guidewire passage.
5. Remove the catheter membrane cover. If there is
resistance in removing the membrane cover from the
catheter, flush the membrane cover with sterile saline.
Inspect the catheter to ensure that air has been purged
from the heat exchange membrane. Inspect the catheter
for leaks.
6. Caution: Avoid excessive wiping of the coated
catheter. Avoid wiping the catheter with dry gauze, as
this may damage the catheter coating. Avoid using
alcohol, antiseptic solutions, or other solvents to pre-
treat the catheter, because this may cause
unpredictable changes in the coating, which could
affect the device safety and performance.
7. Warning: Do not cut the catheter to alter length.
Catheter Insertion
1. Obtain jugular, subclavian, or femoral venous access
using standard percutaneous techniques. Access should
be maintained with a .032" (0.81 mm) guidewire. See
Special Instructions for Guidewires.
2. Warning: Do not attempt to re-insert a partially or
completely withdrawn OTN (over the needle)
introducer needle from its catheter.
3. Caution: Do not use a guidewire larger than .032"
(0.81 mm) with the Cool Line catheter.
4. Holding the guidewire in place, remove the introducer
catheter. Caution: Maintain a firm grip on the
guidewire at all times.
5. Enlarge the cutaneous puncture site with the cutting edge
of the scalpel positioned away from the guidewire.
Warning: Do not cut the guidewire. Use a vessel
dilator to enlarge the site as required. Do not leave the
vessel dilator in place as an indwelling catheter to
minimize the risk of vessel wall perforation

Cool Line®Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
CL-2295A/8700-0781-01
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ZOLL
6. Thread the tip of the catheter over the guidewire. Maintain
a sufficiently firm grip on the guidewire during catheter
insertion. Grasping the catheter tip near the skin, advance
the catheter into the vein with a slight twisting motion.
Continue to advance the catheter over the guidewire,
placing your fingers just proximal to the balloon.
7. Using centimeter marks on the catheter as positioning
reference points, advance the catheter to at least the 18 cm
mark, to ensure the proximal infusion port is in the vessel.
8. Hold the catheter at the desired depth and remove the
guidewire. If resistance is encountered when attempting to
remove the guidewire after catheter placement, the
guidewire may be kinked at the tip of the catheter. If
resistance is encountered, withdraw the catheter relative to
the guidewire about 2-3 cm and attempt to remove the
guidewire. If resistance is encountered again, remove the
guidewire and catheter simultaneously.
9. Caution: Do not apply undue force to the guidewire.
10. Verify that the guidewire is intact upon removal.
11. Check catheter placement by attaching a syringe to the
distal and proximal infusion Luers and aspirate until a free
flow of venous blood is observed. Connect infusion Luers
to appropriate Luer-Lock line(s) as required. Unused
infusion port(s) may be “locked”through injection cap(s)
using standard hospital protocol. Slide clamps are
provided on the tubing to occlude flow through the
infusion Luers during line and injection cap changes.
Caution: To minimize risk of damage to the tubing from
excessive pressure, each clamp must be opened prior to
infusing through that Luer.
12. Caution: Do not clamp or occlude the IN or OUT lines.
This can cause line blockage and possible failure.
13. Secure and dress the insertion site and catheter
temporarily.
14. If subclavian or jugular access is used, verify the catheter
tip position by chest x-ray immediately after placement.
The x-ray exam must show the catheter located in the right
side of the mediastinum in the SVC with the distal end of
the catheter parallel to the vena cava wall. The catheter
distal tip must be positioned at a level above either the
azygos vein or the carina of the trachea, whichever is
better visualized. If the catheter tip is malpositioned,
reposition and reverify.
15. If femoral access is used, x-ray examination must show
the catheter located in the IVC with the distal end of the
catheter parallel to the vena cava wall. If the catheter tip is
malpositioned, reposition and reverify.
16. The proximal radiopaque marker indicates the proximal
end of the balloon. Ensure that the balloon and proximal
port reside completely in the vessel. If the catheter is
malpositioned, reposition and reverify.
17. Secure the catheter to the patient. Use the juncture Luer
side wings as the primary suture site to minimize the risk
of catheter migration.
18. The ZOLL suture tab and clip can also be used as an
additional attachment point. Ensure that the catheter body
is secure and does not slide.
19. Caution: Use only the ZOLL suture tab and clip
provided in the kit. Catheter damage may result if
other tabs or clips are used.
20. Caution: Do not suture directly to the outside diameter
of the catheter to minimize the risk of cutting or
damaging the catheter or impeding catheter flow.
21. Dress the puncture site per hospital protocol. Maintain
the insertion site with regular meticulous redressing using
aseptic technique.
22. Record on the patient's chart the indwelling catheter
length using the centimeter marks on the catheter shaft as
reference. Frequent visual reassessment should be made
to ensure that the catheter has not moved.
23. Attach a primed Start-Up Kit to the catheter by
connecting the male Luer of the Start-Up Kit to the
female IN Luer of the catheter (labeled “IN”) and the
female Luer of the Start-Up Kit to the male OUT Luer of
the catheter (labeled “OUT”). White "ZOLL" tags are
fitted loosely to the IN and OUT extension tubes to help
identify them.
24. The Start-Up Kit IN and OUT Luers are only intended to
connect to the catheter IN and OUT Luers and are not
intended to connect to standard Luer Lock syringes.
They have ZOLL custom fittings and are orange in color
for easy identification.
25. Ensure that a sufficient amount of sterile saline is present
at the ends of the Luers to make an air-free connection.
Refer to the operation manual.
26. Warning: Failure to connect the Start-Up Kit
correctly to the catheter could result in catheter
failure. Do not attach the Start-Up Kit (orange) Luers
to the dark blue, white or brown infusion Luers.
27. Caution: Do not place any stopcocks in line that may
be inadvertently shut off. This can cause line blockage
and possible failure.
28. Pump saline through the Start-Up Kit and catheter to
ensure that all connections are secure and that there is no
leaking. Allow any remaining air in the system to be
purged out.
Disconnecting theCatheter fromtheSystem
1. Stop circulation of saline through the catheter.
2. Disconnect the Start-Up Kit from the catheter.
3. To maintain sterile connections, immediately cap off the
Luer connectors of both the catheter and Start-Up Kit
using sterile Luer caps or connect the IN and OUT Luers
together.
Reconnecting theCatheter to the System
1. Remove the Luer caps from the Luer connectors of the
catheter and Start-Up Kit. Discard the Luer caps or
disconnect IN and OUT Luers from each other.
2. Attach the Start-Up Kit to the catheter by connecting the
male Luer of the Start-Up Kit to the female IN Luer of
the catheter and the female Luer of the Start-Up Kit to
the male OUT Luer of the catheter. The Start-Up Kit and
catheter IN and OUT Luers are orange in color. Ensure
that a sufficient amount of sterile saline is present at the
ends of the Luers to make an air-free connection.
Warning: Failure to connect the Start-Up Kit
correctly to the catheter could result in catheter
failure.
3. Warning: DO NOT confuse the IN and OUT Luer
fittings for standard central line infusion ports. They
are for connection to the Coolgard 3000/Thermogard
XP System ONLY.

Cool Line®Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
CL-2295A/8700-0781-01
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ZOLL
4. The Start-Up Kit IN and OUT Luers are only intended to
connect to the catheter IN and OUT Luers and are not
intended to connect to standard Luer Lock syringes. They
have ZOLL custom fittings and are orange in color for
easy identification.
5. Caution: Do not place any extra stopcocks in line that
may be inadvertently shut off. This can cause line
blockage and possible failure.
Catheter Removal
1. Stop pumping saline through the catheter.
2. Disconnect the Start-Up Kit from the catheter. Uncap or
leave uncapped the IN and OUT Luers of the cooling
circuit (cooling circuit ONLY). This allows residual saline
within the circuit to be expelled. As the catheter is
withdrawn, the balloons are compressed. Saline within the
balloons must be free to pass out of the balloon or the
balloon will not deflate, making the catheter difficult to
remove.
3. Optionally, attach a 20 or 25 cc syringe to the catheter
saline IN Luer. Pull and hold a vacuum for 15 seconds to
allow residual saline to be removed from the catheter
balloon section prior to the start of removing the catheter.
4. For convenience, a 20 or 25 cc syringe is included with
the Start-Up Kit package. Hang it on the saline hook on
the console until ready for use. Discard after each patient.
5. Place the patient in a supine position. Remove the
dressing. Remove the sutures from the suture site.
6. Slowly remove the catheter from patient. As the catheter
exits the site, apply pressure with a dressing impermeable
to air, e.g. Vaseline gauze.
7. Warning: Do not move the catheter if resistance is felt.
Check to ensure that the IN and OUT Luers of the
cooling circuit are NOT capped. If they are capped,
uncap them, deflate the balloon, and try removing the
catheter again. If resistance is still encountered, an x-
ray should be performed to identify the reason for the
resistance.
MRI Safety Information
Non-clinical testing has demonstrated that the
Cool Line catheter is MR Conditional. A patient
with this device can be safely scanned in an MR
system meeting the following conditions:
Static magnetic field of 1.5 T and 3.0 T
Maximum spatial field gradient of 720 gauss/cm
(7.2 T/m)
Maximum MR system reported, whole body averaged
specific absorption rate (SAR) of 2 W/kg (Normal
Operating Mode)
Under the scan conditions defined above, the Cool Line catheter
is expected to produce a maximum temperature rise of less than
2º C after 15 minutes of continuous scanning.
WARNING: The ZOLL Coolgard 3000 and Thermogard
XP Consoles are MR Unsafe. Do not use in the MR Suite.
ZOLL Circulation, Inc.
2000 Ringwood Avenue
San Jose, CA 95131 USA
[phone] (main)
[phone] (fax)
Reorder USA only: [phone]
©2019 ZOLL Medical Corporation. All rights reserved. ZOLL
and Cool Line are trademarks or registered trademarks of
ZOLL Medical Corporation and/or ZOLL Circulation Inc. in
the United States and/or other countries. All trademarks are
the property of their respective owners.
Patent: www.zoll.com/patents

Cool Line®Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
CL-2295A/8700-0781-01
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ZOLL
GuideWire Instructions for Use
Caution: Federal law (USA) restricts this device to sale and
use by or on the order of a physician.
Note: This information applies only to the use of guidewires in
the Seldinger technique of catheter placement in the
vasculature.
Warnings
The supplied guidewire is designed for single use only. Do not
resterilize or reuse. Do not reinsert, once removed from patient.
Should resistance occur during insertion or withdrawal, DO
NOT continue to move the guidewire. Determine the cause
under fluoroscopy and take action as needed.
Use extreme caution when moving a guidewire through a stent.
Use of a guidewire in stented vessels creates additional patient
risk.
Cautions
Avoid withdrawing the guidewire through metal needles; the
guidewire may shear.
Because of the delicate and fragile nature of guidewires, extra
care in handling must be taken. Avoid bending or kinking. Do
not use damaged guidewires.
Sufficient guidewire length must remain exposed to maintain
firm grip on the guidewire at all times.
Dispenser
Every guidewire is provided in a dispenser package. Remove
the guidewire anti-migration clip before dispensing the
guidewire. Remove the guidewire protective cap immediately
prior to guidewire use. Prepare the guidewire prior to insertion.
It is recommended that the dispenser be filled with heparinized
solutions (e.g. saline or dextrose) to bathe the guidewire during
insertion.
The preformed “J” guidewire will resume shape when removed
from the product dispenser.
1 = Guidewire protector cap
2 = Guidewire anti-migration clip
Inspection
Inspect the guidewire prior to use and discard if any deformities
are present in the guidewire. Guidewire placement should be
routinely monitored by x-ray or fluoroscopic procedure.
Technique
1. Puncture the vessel.
2. Insert the guidewire into the needle hub and gently
advance 5-10 cm of the guidewire into the punctured
vessel. Navigate the guidewire to the desired position.
3. Caution: Avoid rough or overly vigorous
manipulation of the guidewire to prevent damage to
the guide or the vessel.
4. Remove the needle from the guidewire.
5. Dilate the tissue and vessel with the dilator using a slight
rotary motion.
6. Remove the dilator. (The vessel dilator is intended for
vascular dilation only.)
7. Introduce the catheter by sliding it over the guidewire.
8. Remove the guidewire.

Cool Line®Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
CL-2295A/8700-0781-01
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ZOLL
1. IN
2. Medial Infusion Lumen
3. Distal Guidewire and Infusion Lumen
4. Proximal Infusion Lumen
5. OUT
6. Radiopaque Shaft
7. Depth Markers
8. Radiopaque Marker
9. Cold Saline Return Port
10. Balloon
11. Cold Saline Supply Port
12. Proximal Infusion Lumen Side Port
13. Balloon
14. Cold Saline Supply Port
15. Medial Infusion Lumen Side Port
16. Radiopaque Tapered Soft Tip
17. Distal Guidewire and Infusion Port
Cool Line CL-2295 Catheter
18. IN
19. OUT Catheter Cross Section

Cool Line®Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
CL-2295A/8700-0781-01
8 of 10
ZOLL

Cool Line®Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
CL-2295A/8700-0781-01
9 of 10
ZOLL

Cool Line®Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
CL-2295A/8700-0781-01
10 of 10
ZOLL
SilvaSorb