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 1
½
“ (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.
Indic
a
tions 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.
