ZOLL ICY IC-3893A User manual

ICY® Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
Model IC-3893A/8700-0782-01
106477-001 Revision 6 1 of 10
ZOLL
Caution: Federal law restricts this device to sale by or on the
order of a physician.
ICY®Intravascular Heat Exchange Catheter (ICY Catheter)
Kit includes:
Quantity
English
1
ICY Catheter 3-Luer
9.3 French x 38 cm
Triple Infusion Luer
Extension Line Clamps
Radiopaque Shaft
Applause Heparin Coating
2
Guidewires .032”(0.81 mm) x 75 cm
1
Vessel Dilator 10.5 F 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 6.3 cm) Radiopaque OTN
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 & 25 ga x 1" (0.5 mm x 2.5 cm )
Needle
2
5 cc Syringes & 22 ga x 1½“ (0.7 mm x 3.8 cm)
Needle
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 ICY Intravascular Heat Exchange Catheter (“ICY Catheter” or
“catheter”) is a sterile, single-use, flexible catheter designed for
placement in the inferior vena cava from an insertion site in the
femoral vein. The ICY Catheter is to be connected to a ZOLL
single use disposable Coolgard 3000®/Thermogard XP®Start-Up
Kit and the Coolgard 3000/ Thermogard XP System (both supplied
separately). An YSI-400 Temperature probe is required for the
operation of the Coolgard 3000 or Thermogard XP. A dilator and
guidewire are required for the percutaneous insertion of the ICY
Catheter. Three (3) Luers are available for infusion and sampling.
Infusion Port
Flow Rate
Priming
Volume
Guidewire Port (brown)
1700 ml/hr
0.5 cc
Medial Port (white)
900 ml/hr
0.4 cc
Proximal Port (blue)
1200 ml/hr
0.4 cc
The ICY catheter blood contact surfaces (tip, balloon, and shaft) are
treated with an anti-thrombotic Applause heparin coating.
Sterility
Ethylene oxide sterilized. The ICY 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°C-25°C. Avoid freezing and excessive heat
above 40°C.
Indications for Use
The ZOLL®ICY Intravascular Heat Exchange Catheter Model IC-
3893A, connected to the ZOLL Coolgard 3000/Thermogard XP
Thermal Regulation System, is indicated for use:
In cardiac surgery adult patients to achieve and/or maintain
normothermia during surgery and recovery/intensive care,
and
To induce, maintain and reverse mild hypothermia in
neurosurgery adult patients in surgery and recovery/intensive
care.
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 that
will not accommodate a catheter, including patients with
vena cava filters or other implanted impediments to passage
of the 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 anaemia can be
precipitated by cold including Sickle Cell Disease or
Thalassemia.
8. Not intended for pediatric or neonatal use.
Warnings and Precautions
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.
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: 4 days.
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: The ICY Catheter and Start-Up Kit could
potentially misconnect with other devices with small bore
connectors. Such connection errors could result in patient
injury or death.

ICY® Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
Model IC-3893A/8700-0782-01
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WARNING: The catheter should be placed via a 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.
CAUTION: The custom Luers contained on the ICY 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 ICY Catheter and/or Start-Up Kit
are not connected to an IV or other medical devices.
1. The catheter should be positioned so that the distal tip of the
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.
2. 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.
3. Alcohol and acetone can weaken the structure of the shaft
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 saline circuit, stop
the procedure.
6. The catheter is coated with heparin. This may induce or
aggravate pre-existing heparin-induced thrombocytopenia
(HIT).
7. 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.
8. All Luer-Lock connections and covers must be securely
tightened to prevent air embolism or fluid or blood loss.
9. 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.
10. Passage of the guidewire into the right heart can cause
dysrhythmias, right bundle branch block, vessel wall, atrial or
ventricular perforation.
11. Use only sterile normal saline for catheter priming. It is the
circulating fluid in the catheter.
12. The catheter should be routinely inspected for flow rate,
security of dressing, correct catheter position, and secure
Luer-Lock connections. Use the centimeter markings to
identify if the catheter position has changed.
13. 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 the catheter tip position.
14. For blood sampling, temporarily shut off the remaining
infusion ports through which solutions are being infused.
15. Use only a 30 cc or smaller syringe for blood sampling.
16. Use only the ZOLL suture tab and clip provided in the kit to
prevent catheter damage.
17. Do not infuse into the “IN” and “OUT” Luer-Lock
connections.
18. Use care when infusing drugs that may be affected by cool
temperatures (as low as 4ºC). Solutions containing Mannitol
are temperature-sensitive and must not be delivered through
the catheter except for a rapid push of a solution of up to 20%
mannitol, followed by a saline flush. Higher than a 20%
concentration of mannitol or a drip or infusion pump delivery
of mannitol must be done via a separate line.
19. WARNING: When connecting infusion sets/injection
systems to ZOLL Catheters do not exceed
100 psi/689 kPa.
20. 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 PaCO2. Physicians should be aware 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 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).
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.

ICY® Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
Model IC-3893A/8700-0782-01
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4. Connect the syringe to the IN Luer of the catheter and
disconnect the OUT cap. Infuse 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 (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 peristaltic (roller) pump 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 ICY Catheter Kit for percutaneous introduction
1 500 cc bag of sterile normal saline (not provided)
1 CoolGard 3000 or Thermogard XP Start-Up Kit
(provided separately)
6 ft (183 cm) Standard Tubing or
9 ft (274 cm) Extended Tubing
1 Coolgard 3000 or Thermogard XP System (provided
separately)
1 YSI-400 Temperature Probe (not provided)
Catheter Preparation and Insertion
NOTE: The ICY 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.
Catheter Preparation Procedure
1. Using sterile technique, remove the catheter from the kit.
Carefully remove the catheter from the package, leaving on
the catheter membrane cover.
2. Caution: Always prime the catheter before it is inserted
into the patient.
3. 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.
4. Remove the caps from the IN and OUT Luers. With the
catheter cover in place, fill the syringe (5 cc or larger) with
sterile saline and attach the syringe to the female IN Luer.
5. WARNING: Never inject positive pressure into the IN
Luer with the OUT Luer cap in place.
6. Gently inject saline through the catheter until it begins to exit
from the OUT Luer.
7. Using a 5 cc or larger syringe, flush the distal, proximal and
medial infusion Luers with sterile saline. Clamp or attach
injection caps to the proximal and medial infusion Luers.
Leave the distal Luer uncapped for guidewire passage.
8. 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.
9. 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.
10. WARNING: Do not cut the catheter to alter length.
Catheter Insertion
1. WARNING: Use femoral vein approach only.
2. Place the patient in a supine position.
3. Prep and drape the puncture site as required.
4. Caution: Always prime the catheter infusion Luers before
inserting the catheter into the patient.
5. Obtain femoral venous access using standard percutaneous
techniques. Access should be maintained with a .032”
(0.81 mm) guidewire. See Guidewire Instructions for Use.
6. WARNING: Do not attempt to reinsert a partially or
completely withdrawn OTN (over the needle) introducer
needle from its catheter.
7. Holding the guidewire in place, remove the introducer
catheter. Caution: Maintain a firm grip o
8. Enlarge the cutaneous puncture site with cutting edge of scalpel
positioned away from the guidewire. WARNING: Do not cut
guidewire. Use vessel dilator to enlarge site as required. Do not
leave vessel dilator in place as an indwelling catheter to
minimize risk of possible vessel wall perforation.
9. Remove the catheter membrane cover.
10. Thread the tip of the ICY 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.

ICY® Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
Model IC-3893A/8700-0782-01
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11. Using centimeter marks on the catheter as positioning
reference points, advance catheter to at least the 18 cm mark,
to ensure the proximal infusion port is in the vessel.
12. 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.
13. Caution: Do not apply undue force to the guidewire.
14. Verify that the guidewire is intact upon removal.
15. Check catheter placement by attaching a syringe to the distal
infusion Luer and aspirate until a free flow of venous blood is
observed. Connect the infusion Luer to the appropriate Luer-
Lock line as required. The unused infusion port may be
"locked" through the injection cap using standard hospital
protocol. A slide clamp is provided on the tubing to occlude
flow through the infusion Luer during line and injection cap
changes. Caution: To minimize risk of damage to the
tubing from excessive pressure, the clamp must be opened
prior to infusing through the Luer.
16. Caution: Do not clamp or occlude IN or OUT lines. This
can cause line blockage and possible failure.
17. Secure and dress the insertion site and catheter temporarily.
18. Verify the catheter tip position by chest x-ray immediately
after placement. The x-ray exam 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 re-verify.
19. 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 re-verify.
20. Secure the catheter to the patient. Use the juncture Luer side
wings as the primary suture site to minimize the risk of
catheter migration.
21. The ZOLL suture tab and clip can also be used as an
additional attachment point. Ensure that catheter body is
secure and does not slide.
22. Caution: Use only the ZOLL suture tab and clip provided
in the kit. Catheter damage may result if other tabs or
clips are used.
23. 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.
24. Dress the puncture site per hospital protocol. Maintain the
insertion site with regular meticulous redressing using aseptic
technique.
25. 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.
26. 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 and the female Luer of the Start-Up Kit to the
male OUT Luer of the the catheter. White "ZOLL" tags are
fitted loosely to the IN and OUT extension tubes to help
identify them. 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.
27. 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.
28. 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 brown,
white or blue infusion Luers.
29. Caution: Do not place any stopcocks in line that may be
inadvertently shut off. This can cause line blockage and
possible failure.
30. 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 as
described in the system operation manual.
Disconnecting theCatheter from the System
1. Stop circulating 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 Luer connectors of the catheter
and Start-Up Kit. Discard the Luer caps or disconnect the 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.
3. WARNING: Failure to connect the Start-Up Kit
correctly to the catheter could result in catheter failure.
4. WARNING: DO NOT use the IN and OUT Luer fittings
for standard central line infusion ports. They are for
connection to the Coolgard 3000/Thermogard XP System
ONLY.
5. 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.
6. Caution: Do not place any extra stopcocks in line that
may be inadvertently shut off. This can cause line
blockage and possible failure.

ICY® Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
Model IC-3893A/8700-0782-01
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Catheter Removal
1. Stop pumping saline through the catheter.
2. Disconnect the Start-Up Kit from the catheter. Uncap or
leave uncapped the saline IN and OUT Luers of the catheter.
This will allow residual saline within the circuit to be
expressed. 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 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
ICY 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 ICY 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 Ave.
San Jose, CA 95131 U.S.A.
[phone] (main)
[phone] (fax)
Reorder USA only: [phone]
©2019 ZOLL Medical Corporation. All rights reserved. ZOLL and
ICY 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

ICY® Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
Model IC-3893A/8700-0782-01
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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 its 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. Guidewire placement should be
routinely monitored by x-ray or fluoroscopy.
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.
Caution: Avoid rough or overly vigorous
manipulation of the guidewire to prevent damage to
the guide or the vessel.
3. Remove the needle from the guidewire.
4. Dilate the tissue and vessel with the dilator, using a slight
rotary motion.
5. Remove the dilator. (The vessel dilator is intended for
vascular dilation only.)
6. Introduce the catheter by sliding it over the guidewire.
7. Remove the guidewire.

ICY® Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
Model IC-3893A/8700-0782-01
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1. OUT
2. IN
3. Medial
4. Distal
5. Proximal
6. Detail view ICY IC-3893A Catheter
Shaft
7. Balloon 5 mm x 80.5 mm
8. Balloon 8 mm x 80.5 mm Balloons

ICY® Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
Model IC-3893A/8700-0782-01
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ICY® Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
Model IC-3893A/8700-0782-01
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ICY® Intravascular Heat Exchange Catheter (Custom Luer)
Instructions for Use
Model IC-3893A/8700-0782-01
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ICY
SilvaSorb