ZOLL Quattro IC-4593AE/8700-0660-40 Mode D'emploi page 2

English (en)
Model IC-4593AE/8700-0660-40 &
IC-4593CO/8700-0624-40
Includes:
Quantity
®
1 AE(CO)
Quattro Catheter
3-Lumen 9.3 French x 45cm
Triple Infusion Lumen
Extension Line Clamps
Radiopaque Polyurethane
Applause™ Heparin Coated
2 AE(CO) Guidewire 0.032" (0.81 mm) x 90 cm
1 AE(CO) Vessel Dilator 10.5 F x .038"
(3.6 mm x 1.0 mm)
1 AE(CO) Detachable Suture Tab & Clip
1 AE 18 ga x 2½" (1.3 mm x 63 mm)
Radiopaque OTN Catheter
1 AE 5cc Syringe & 22ga x 1½"
(0.7mm x 38 mm) Needle
1 AE Fenestrated Drape
1 AE 18ga x 2¾" (1.3mm x 70mm) Needle
6 AE 4" x 4" (10 cm x 10 cm) Gauze
Sponges
1 AE 000 Silk Suture
1 AE No. 11 Surgical Blade w/ long handle
NOTE - KIT COMPONENTS BY MODEL:
Each base model is available either with a standard
supporting insertion kit (AE) or without the standard
supporting insertion kit (CO). The components
common to both kits are labeled AE(CO) in the table
above. The additional components found only in the
standard kit are labeled AE.
Device Description:
The Quattro Heat Exchange Catheter is a sterile, single
use flexible 9.3F 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 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 Quattro Catheter. Three (3) lumens are
available for infusion and sampling.
Flow rate
Port
ml/hr
1300
Guidewire (brown)
ml/hr
Medial (white) 800 ml/hr
1100
Proximal (blue)
ml/hr
Insertion Size
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.
106142-001
IC-4593AE/8700-0660-40 & IC-4593CO/8700-0624-40
Storage:
Store at room temperature, 15-40ºC.
The Quattro blood contact surfaces are Applause
heparin treated. Applause is a trademark of SurModics
Inc., registered in the U.S. Patent and trademark office.
Indications for Use:
The Quattro Catheter in combination with the
CoolGard 3000
circulation of temperature controlled saline through a
heat exchanger to cool / rewarm the patient's blood in
patients for whom the risks of a central line are
warranted. Maximum use period:4 days.
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:





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.
3
cm
Warnings and Precautions:
1. Catheter should be placed via a femoral vein
0.6 cc
approach only.
2. Do not allow catheter to be placed into right
0.4 cc
atrium or right ventricle. Catheter should be
positioned so that the distal tip of catheter is in
0.4 cc
the inferior vena cava below its junction with the
right atrium and parallel to the vessel wall.
3. X-ray examination should be used to ensure that
the catheter is not in the right atrium or ventricle.
9.3F
4. 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.
® ®
/Thermogard XP System permits
Potentially life threatening infection
Toxic shock due to degradation
of materials
Increased risk of thrombosis
Reduced heat exchange power
Device failures
Revision 7
ZOLL
5. All Luer-Lock connections and covers must be
securely tightened to prevent air embolism or
fluid or blood loss.
6. 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.
7. Passage of the guidewire into the right heart can
cause dysrhythmias, right bundle branch block,
vessel wall, atrial or ventricular perforation.
8. Use only sterile normal saline for catheter
priming and as the circulating fluid in the
catheter.
9. Catheter should be routinely inspected for
flow rate, security of dressing, correct catheter
position and for secure Luer-Lock connection.
Use centimeter markings to identify if the
catheter position has changed.
10. 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 catheter
position has changed, perform an x-ray
examination to confirm catheter tip position.
11. For blood sampling, temporarily shut off
remaining infusion ports through which
solutions are being infused.
12. Use only a 30cc or smaller syringe for blood
sampling.
13. Alcohol and acetone can weaken the structure
of the polyurethane 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.
14. Use only ZOLL suture tab and clip provided
in kit to prevent catheter damage.
15. Use of a syringe smaller than 10 ml to irrigate
or declot an occluded catheter may cause
intraluminal leakage or catheter rupture.
16. Do not infuse into the INFLOW and OUTFLOW
Luer-Lock connections.
17. Fever may have infectious and/or non-infectious
causes in patients. The absence of fever
necessitates daily, meticulous assessment for
other signs of infection.
18. 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
Quattro Catheter. except for 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.
19. Not intended for pediatric or neonatal use.
20. 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.
21. The catheter is coated with heparin. This may
induce or aggravate pre-existing heparin induced
thrombocytopenia (HIT).
22. Warning:When connecting infusion
sets/injection systems to ZOLL Catheters do
not exceed 100 psi/689 kPa.
23. For patients being made hypothermic, the
hypothermia itself may exacerbate some disease
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