ZOLL IVTM Catheter Quattro - Manual

Quattro
®
Catheter
Instructions for Use
Model IC4593/8700-0660-01
1 of 11
106083-001 Rev 2
Caution: Federal law restricts this device to sale by or on
the order of a physician.
Model IC4593/8700-0660-01
Includes:
Quantity English
1 Quattro ® Catheter 3-Lumen
9.3 French x 45cm
Triple Infusion Lumen
Extension Line Clamps
Radiopaque Polyurethane
Applause™ Coated
1 Guidewires (.032” x 90cm)
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
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 Quattro ® 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
Quattro
® Catheter is to be connected to a single use
disposable Start-Up Kit (supplied separately) and ZOLL Heat
Exchange System. A dilator and guidewire are required for
the percutaneous insertion of the
Quattro ® Catheter. Three
(3) lumens are available for infusion and sampling.
Flow rate
ml/hr
Priming
Volume
Guidewire
Port (brown)
1300 ml/hr 0.6 cc
Medial Port
(white)
800 ml/hr 0.4 cc
Proximal
Port (blue)
1100 ml/hr 0.4 cc
Insertion Size
IC4593 9.3F
The Quattro ® 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 Quattro ® 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 Quattro ® Catheter Model IC-4593, connected to a
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 can be precipitated by cold
including Sickle Cell Disease or Thalassemia.