ZOLL IVTM Catheter Icy - Manual

Icy
®
Catheter
Instructions for Use
Model IC-3893A/8700-0657-01 (Also referred to as IC-3893)
1 of 11 106085-001 Rev.2
Caution: Federal law restricts this device to sale by or on
the order of a physician.
Model IC-3893A/8700-0657-01 (Also referred
to as IC-3893)
Includes:
Quantity English
1 Icy ® Catheter 3-Lumen
9.3 French x 38cm
Triple Infusion Lumen
Extension Line Clamps
Radiopaque Polyurethane
Applause™ Coated
2 Guidewires (.032” x 75cm)
1 Vessel Dilator
1 Detachable Suture Tab & Clip
1 18ga x 2 ½" (6.3cm) Radiopaque 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 5cc Ampule Lidocaine HCL 1%
1 Needle Disposal Cup
1 SilvaSorb ® Site Antimicrobial Dressing
1 SureSite Transparent Film Dressing
Device Description:
The Icy® Heat Exchange Heat 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 (supplied
separately) and the CoolGard 3000 ® /Thermogard XP ®
System. A dilator and guidewire are required for the
percutaneous insertion of the
Icy ® Catheter. Three (3)
lumens are available for infusion and sampling.
Flow rate
ml/hr
Priming
Volume
Guidewire
Port (brown)
IC-3893 1700 ml/hr 0.5 cc
Medial Port
(white)
IC-3893 900 ml/hr 0.4 cc
Proximal
Port (blue)
IC-3893 1200 ml/hr 0.4 cc
Insertion Size
IC-3893 9.3F
The Icy ® 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 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 20-25°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 ZOLL Icy ® Catheter Model IC-3893A, connected
to the ZOLL 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.
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: 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.
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 vascular
system will not accommodate 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