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Quattro® Catheter Instructions for Use
Model IC4593/8700-0660-01
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 |
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9.3 French x 45cm |
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Triple Infusion Lumen |
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Extension Line Clamps |
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Radiopaque Polyurethane |
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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.
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Flow rate |
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Priming |
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ml/hr |
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Volume |
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Guidewire |
1300 ml/hr |
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0.6 cc |
Port (brown) |
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Medial Port |
800 ml/hr |
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0.4 cc |
(white) |
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Proximal |
1100 ml/hr |
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0.4 cc |
Port (blue) |
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Insertion Size |
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IC4593 |
9.3F |
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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.
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Storage:
Store between 20-25°C. Avoid freezing and excessive heat above 40°C.
United States Patent Nos.: |
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6,126,684 |
6,299,599 |
6,409,747 |
6,416,533 |
6,585,692 |
6,645,234 |
6,652,565 |
6,656,209 |
6,719,724 |
6,749,585 |
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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.
106083-001 Rev 2
Quattro® Catheter Instructions for Use
Model IC4593/8700-0660-01
Warnings and Precautions:
1.SINGLE USE ONLY. 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. Maximum use period: 4 days.
2.Do not allow catheter to be placed into right atrium or right ventricle. Catheter should be positioned so that the distal tip of 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.
3.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.
4.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.
5.Use of a syringe smaller than 10 ml to irrigate or declot an occluded catheter may cause intraluminal leakage or catheter rupture.
6.Caution: If blood is observed within the circuit circulating the sterile saline, stop the procedure.
7.The catheter is coated with Heparin. This may induce or aggravate pre-existing Heparin induced thrombocytopenia (HIT).
8.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.
9.Catheter should be placed via a femoral vein approach only.
10.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 dysrhythmia.
11.All Luer-Lock connections and covers must be securely tightened to prevent air embolism or fluid or blood loss.
12.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.
13.Passage of the guidewire into the right heart can cause dysrhythmias, right bundle branch block, vessel wall, atrial or ventricular perforation.
14.Use only sterile normal saline for catheter priming and as the circulating fluid in the catheter.
15.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.
16.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.
17.For blood sampling, temporarily shut off remaining infusion ports through which solutions are being infused.
18.Use only a 30cc or smaller syringe for blood sampling.
19.Use only ZOLL suture tab and clip provided in kit to prevent catheter damage.
20.Do not infuse into the teal-green Luer-Lock connections.
21.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.
22.When connecting infusion sets/injection systems to ZOLL Catheters do not exceed 100 psi/689 kPa.
23.Not intended for pediatric or neonatal use.
24.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 that 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 lumen and infusion lumens 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).
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106083-001 Rev 2
Quattro® Catheter Instructions for Use
Model IC4593/8700-0660-01
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 and properly cap both the catheter and Start-Up Kit using an aseptic technique.
3.Fill a sterile 10 ml syringe with sterile saline.
4.Connected to the INFLOW lumen of the catheter and disconnect the outflow cap. Infuse the 10 ml of saline – it should flow out the outflow lumen.
5.Now cap the OUTFLOW lumen and pull 5 cc of vacuum and sustain this for at least 10 seconds. Approximately 4 ml of saline, but not blood, should enter the syringe and you should be able to maintain the vacuum.
6.Ease the vacuum and recap the INFLOW lumen.
To check the integrity of the tubing set:
1.Look for obvious leakage.
2.Remove the tubing from the pump raceway 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).
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 |
Quattro® Kit for percutaneous introduction |
1 |
Bag of Normal Saline |
1 |
Start-Up Kit |
1 |
CoolGard 3000®/Thermogard XP® System |
Catheter Preparation and Insertion:
Use sterile technique.
1.Caution: Use femoral vein approach only.
2.Place patient in a supine position.
3.Prep and drape puncture site as required.
4.Caution: Always prime catheter before it is inserted into patient.
5.Carefully remove catheter from package, leaving on catheter membrane cover.
Catheter Preparation Procedure:
1.Remove caps from the inflow and outflow luer hubs. With the catheter cover in place, fill syringe (5cc or
larger) with sterile saline and attach syringe to female inflow luer hub.
2.Warning: Never inject positive pressure into the inflow hub with the outflow luer cap in place.
3.Gently inject saline through catheter until it begins to exit from outflow luer.
4.Using 5 cc or larger syringe, flush the distal infusion lumen with sterile saline. Leave the distal luer uncapped for guidewire passage.
5.Remove catheter membrane cover . If there is resistance in removing the membrane cover from the catheter, flush the membrane cover with sterile saline. Inspect catheter to assure that air has been purged from the heat exchange membrane. Inspect the catheter for leaks.
6.Warning: Do not cut the catheter to alter length.
Catheter Insertion:
1.Obtain femoral venous access using standard percutaneous techniques. Access should be maintained with a .032" guidewire. See special instructions for Guidewires.
2.Warning: Do not attempt to re-insert a partially or completely withdrawn OTN (over the needle) introducer needle from its catheter.
3.Caution: Do not use a guidewire larger than .032" with the Quattro® Catheter.
4.Holding spring guidewire in place, remove introducer catheter. Precaution: Maintain a firm grip on the guidewire at all times.
5.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
6.Thread tip of Quattro® over guidewire. Maintain a sufficiently firm grip on the guidewire during catheter insertion. Grasping near skin, advance catheter into vein with a slight twisting motion.
7.Using centimeter marks on the catheter as positioning reference points, advance catheter to final indwelling position.
8.Hold catheter at desired depth and remove guidewire. If resistance is encountered when attempting to remove the guidewire after catheter placement, the guidewire may be kinked about 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 again encountered remove the guidewire and catheter simultaneously.
9.Caution: Do not apply undue force to the guidewire.
10.Verify that the guidewire is intact upon removal.
11.Check lumen placement by attaching a syringe to the distal infusion luer hub and aspirate until a free flow of venous blood is observed. Connect infusion luer to appropriate Luer-Lock line as required. Unused infusion port may be "locked" through injection cap using standard hospital protocol. A slide clamp is provided on the tubing to occlude flow through the
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106083-001 Rev 2
Quattro® Catheter Instructions for Use
Model IC4593/8700-0660-01
infusion lumen during line and injection cap changes. Precaution: To minimize risk of damage to the tubing from excessive pressure, the clamp must be opened prior to infusing through the lumen.
12.Caution: Do not clamp or occlude inflow or outflow lines. This can cause line blockage and possible failure.
13.Secure and dress insertion site and catheter temporarily.
14Verify catheter tip position by chest x-ray immediately after placement. 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 reverify.
15.Proximal radiopaque marker indicates proximal end of balloons to ensure that balloons reside completely in vessel. If catheter is malpositioned, reposition and reverify.
16.Secure catheter to patient. Use juncture hub side wings as primary suture site to minimize the risk of catheter migration.
17.The ZOLL suture tab and clip can also be used as an additional attachment point. Assure that catheter body is secure and does not slide.
18.Caution: Use only the ZOLL suture tab and clip provided in the kit. Catheter damage may result if other tabs or clips are used.
19.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.
20.Dress puncture site per hospital protocol. Maintain the insertion site with regular meticulous redressing using aseptic technique.
21.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.
22.Attach a primed Start-Up Kit to Quattro® Heat
Exchange Catheter by connecting the male luer of the Start-Up Kit to the female inflow luer of the Quattro®
catheter and the female luer of the Start-Up Kit to the male outflow luer of the Quattro® Catheter. White " ZOLL" tags are fitted loosely to the INFLOW and OUTFLOW extension tubes to help identify them. Assure that a sufficient amount of sterile saline is present at the ends of the hubs to make an air free connection. Refer to CoolGard 3000®/Thermogard XP® manual for details on CoolGard 3000®/Thermogard XP® operation.
23.Warning: Failure to connect the Start-Up Kit correctly to the catheter could result in catheter failure. Do not attach Start-Up Kit to the brown luer.
24.Caution: Do not attach Start-Up Kit to distal port.
25.Caution: Do not place any stopcocks in line that may be inadvertently shut off. This can cause line blockage and possible failure.
26.Pump saline through Start-Up Kit and catheter to assure that all connections are secure and that there is no leaking. Allow any remaining air in system to be purged out.
Disconnecting Catheter from CoolGard 3000®/Thermogard XP® System:
1.Stop circulation of saline through catheter.
2.Disconnect Start-Up Kit from catheter.
3.To maintain sterile connections, immediately cap off luer connectors of both catheter and Start-Up Kit using sterile luer caps or connect inflow and outflow luers together.
Reconnecting Catheter to CoolGard 3000®/Thermogard XP® System:
1.Remove luer caps from luer connectors of catheter and Start-Up Kit and discard or disconnect inflow and outflow luers from each other.
2.Attach Start-Up Kit to Quattro® Heat Exchange Catheter by connecting the male luer of the Start-Up Kit to the female inflow luer of the Quattro® Catheter
and the female luer of the Start-Up Kit to the male outflow luer of the Quattro® Catheter. Assure that a sufficient amount of sterile saline is present at the ends of the hubs 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 confuse the INFLOW and OUTFLOW Luer fittings for standard central line
infusion ports. They are for connection to the CoolGard 3000®/Thermogard XP® System ONLY.
5.Caution: Do not place any extra stopcocks in line that may be inadvertently shut off. This can cause line blockage and possible failure.
Catheter Removal:
1.Stop all pumping of saline through the catheter.
2.Disconnect Start-Up Kit from catheter. Uncap or leave uncapped the inflow and outflow lumens of the cooling circuit (cooling circuit ONLY). This will allow residual saline within the circuit to be expressed. As 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.Place patient in supine position. Remove dressing. Remove sutures from suture site.
4.Slowly remove catheter from patient. As catheter exits the site apply pressure with a dressing impermeable to air, e.g. vaseline gauze.
5.Warning: Do not move catheter if resistance is felt. Check to ensure that the inflow and outflow lumens of the cooling circuit are NOT capped. If they are capped, uncap them and try removing the catheter again. If resistance is still encountered, an x-ray should be performed to identify the reason for the resistance.
ZOLL Circulation, Inc. Sunnyvale, CA 94085 USA +1-408-541-2140
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106083-001 Rev 2
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