ZOLL IVTM Catheter Cool Line User Manual

Cool Line® Catheter

Applause™ Coated

Guidewires (.032" x 65cm)

Vessel Dilator

Detachable Suture Tab & Clip

18ga x 2 ½" (6.4cm) Radiopaque PTFE OTN Catheter

000 Silk Suture

25ga x 1" (2.5 cm ) Needle

Chloraprep® Triple Swabstick Prep Pack

4" x 4" Gauze Sponges

No. 11 Surgical Blad e w/ lon g handle

5cc Syringes

Fenestrated Drape

22ga x 1 ½" (3.8 cm) Needles

18ga x 2 ¾" (7.0 cm) Needle

5 cc Ampule Lidocaine HCL 1%

Needle Disposal Cup

SilvaSorb® Site Antimicrobial Dressing

Suresite® Transparent Film Dressing

Priming

Proximal Port

18 Ga

1400 ml/hr

0.3 cc

Medial Port

18 Ga

1200 ml/hr

0.3 cc

Guidewire Port

16 Ga

2100 ml/hr

0.4 cc

Model CL-2295

9.3F 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

n N % n N %

CI 3 16

18.8 3 14

21.4

0.74

ICH 8 33

24.2 7 27

25.9

1.00

PTBI

22.7 4 38

10.5

0.24

SAH

21.3 7 63

11.1

0.15

Instructions for Use

CL-2295A/8700-0654-01 (Also referred to as CL-2295)

Caution: Federal law restricts this device to sale by or on

the order of a physician.

Model CL-2295A/8700-0654-01 (Also referred to as CL-2295)

Includes:

9.3 French x 22cm Tri Infusion Lumen Extension Line Clamps Radiopaque Polyurethane

1 3cc Syringe

1 Povidone Ointment

Device Description:

The Cool Line® Heat Exchange Catheter is a sterile, sing le use flexible catheter des igned for placement in the centr al venous circulation from an insertion site in the jugular, subclavian, or femoral veins. The Cool Line be connected to a single u s e disposable CoolGard

3000

/Thermogard XP® Start-Up Kit (supplied separately) and the CoolGard 3000 and guidewire are required for the percutaneous insertion of the Cool Line infusion, measuring central venous pressure or sampling.

(blue)

(white))

(brown)

Insertion size:

/Thermogard XP® System. A dilator

Catheter. Th ree lumens are available for

Size Flow R ate

Catheter is to

Volume

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 f reezing and exces sive heat above 40°C.

United States Patent Nos.:

6,749,585

Other U.S. and foreign patents pending.

Indications for Use:

The Cool Line® Catheter Model CL-2295A when used with the ZOLL Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral infarction and intrace r e br al hemorrhage who require access to the central venou s circulation an d who are intubated and sedated.

Safety and Efficacy Considerations:

Central venous catheterization should only be performed by wel l-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 res terilize 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 – Fever Reduction

The safety of this device has not been demonstrated for fever red uction in patients presenting with subarachnoid hemorrhage or primary traumatic brain inj ury. The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The mortality results reported in this trial, for th e fou r pa tient cohorts enrolled, are presented in t he table below (CI – cerebral infarction, ICH – intracerebral hemorrhage, PTBI – primary traumatic brain injury, SAH – subarachnoid hemorrhage).

Mortality by Diagnosis (ITT analysis)

Cool Line Control

The Cool Line® Catheter blood contact surfaces are Applause™ treated. Applause is a trademark of SurModics, Inc., registered i n the U.S. Patent and trademark office.

Sterility

Ethylene oxide sterilized. The Cool Line® Catheter is supplied sterile for single use only and should not be

1 of 11 106084-001 Rev.2

*Fischer’s exact test

For more details on the clinical trial results please refer to Physician’s Manual – “Normothermia for the Neurocritically Ill s troke patient” #10 1416-001.

Warning: Do not allow catheter to be placed into right atrium or right ventricle. Placement in right atrium or right vent ricle can result in severe patient injury or death.

Cool Line® Catheter

Instructions for Use

CL-2295A/8700-0654-01 (Also referred to as CL-2295)

Contraindications:

1. The risks of t he catheter are essentially tho se of a

central line. The catheter should not be used in patients for whom cen tral line placement is not indi cated.

2. Bleeding diathesis.

3. Active sepsis.

4. Infection o r active bleeding at the site of catheter

insertion.

5. Patients with no vascular access, or vascular system

will not accommodate catheter.

6. Patients for whom the req uired temperature monitorin g

cannot be established.

Warnings and Precautions:

1. SINGLE USE ONLY. Product designed for single

use only. Do no t resterilize or reuse. Do not rei nsert, once removed from patient. Do not alter the catheter in any way. Maximum use period: 7 days.

2. The use of intravascular cooling devices controls fever,

including fever due to sepsis. Care must be taken to assess patients for sepsis.

3. Alcohol and acetone can weaken the structure of the

polyureth ane 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.

4. Use of a syringe smaller than 10 ml to irrigate or declot

an occluded catheter may cause intraluminal leakage or catheter rupture.

5. Caution: If blood is observed within the circuit

circulating the sterile saline, stop the procedure.

6. The catheter is coated with Heparin. This may induce

or aggravate pre-existing Heparin induced thrombocytopenia (HIT).

7. Central venous catheterizat ion should only be

performed by well-trained personnel well versed in anatomical landmarks and safe technique. Personnel should also have knowledge of potential complications.

8. Catheter should be placed via a jugular, subclavian, or

femoral vein approach only.

9. Do not allow catheter to be placed into right atrium or

right ventricle. If placed via the jugular or subclavian veins, catheter should be positioned so that the distal tip of catheter is in the superior vena cava above 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. The distal tip of the catheter should be positioned at a level above either the azygos vein o r the carina of the trachea, whichever is better visualized.

10. If placed vi a the femoral vein, the catheter s hould be

positioned so that the distal tip of catheter is in the inferior vena cava below its junction with the right atrium and pa rallel to the vessel wall.

11. Possible c o mplications with central venous catheters

include: atrial or ventricular perforation, cardiac tamponad e, air embolism, catheter embolism, thoracic duct laceration, bacte r e m ia, sept icemia, thrombosis, inadvertent arterial puncture, hematoma formation, hemorrhage, nerve damage and dysrhythmias.

2 of 11 106084-001 Rev.2

12. All Luer-Lock connections and covers must be

securely tightened to prevent air embolism or fluid or blood loss.

13. Never use exces sive force in moving the catheter or

guidewire. If resistance is encountered, an x-ray should be performed to identify the reason for the resistance.

14. Passage of the guidewire into the right heart can

cause dysrhythmia s, right bundle branch block, vessel wall, atrial or ventricular perforation.

15. Use only sterile normal sali ne for catheter p r iming

and as the circulating fluid in the catheter.

16. Catheter should be routinely inspected for flow rate,

security of dressing, correct catheter positi on and for secure Luer-Lock connection. Use centimeter markings to identify if the catheter position has changed.

17. Only x-ray examination can ensure that the catheter

tip has not ent ered 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.

18. For blood sampling, temporarily shut off remaining

19. Use only a 30cc or smaller s yringe for blood

20. Use care when infusing drugs that may be affected

21. Do not infuse into the teal-green Luer-Lock

22. Use only the ZOLL suture tab and clip provided in

23. Not intend ed for pediatri c o r neonatal use.

24. Cardiac Tamponade: Placement of indwelling

25. When connecting infusion sets/injection systems to

WARNING: INTRALUMINAL LEAKAGE

Intraluminal leakage between the saline lumen and infusion lumens is an unc om mon 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

ports through which solutions are being

infusion infused.

sampling.

by cool temperatures (as low as 4ºC). Mannitol containing solutions are t emperature sensitive and must not be delivered through the Cool Li n e 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.

connections.

kit to prevent catheter damage.

catheters in the right atrium is a practice that may lead to cardiac perforation and tamponad e. Practitioners placing central venous catheters must be aware of this potentially fatal complication before advancing the catheter to o f ar 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 procedu res, such as aspiration of air emboli during neurosurgery. Such procedures are nevertheless risk prone and should be closely monitored and controlled.

ZOLL Catheters do not ex ceed 100 psi/ 68 9 kP a.

Cool Line® Catheter

Instructions for Use

CL-2295A/8700-0654-01 (Also referred to as CL-2295)

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).

To check the integrity of the catheter:

1. Stop operation of the C oolGard 3000

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. 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 Start-Up Kit:

1. Look for obvious leaka ge.

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 necess ar y, each Luer fitting (do not use instruments to tighten Luer

4. Similarly, check the tubing that returns to the pump

5. Trace the tubing from the saline bag back to the pump. More warnings and preca utions are located in following instructions.

fittings).

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).

/Thermogard

Materials Required:

Quantity Description

1 Cool Line

introduction 1 Bag of Normal Saline 1 Start-Up Kit 1 CoolGard 3000

Kit for percutaneous

/Thermogard XP® System

Catheter Preparation and Insertion:

Use sterile technique.

1. Caution: Use jugular, subclavian, or fe mo ral vein approach only.

2. Place patient in a slight Trendelenburg position as tolerated to reduce the risk of air embolism. If femora l approach is used, place patient in supine position.

3. Prep and drape puncture site as required.

4. Caution: Always prime catheter before it is inserted into patient.

5. Carefully rem ove catheter from package leaving on catheter membrane cover.

3 of 11 106084-001 Rev.2

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 sali ne and attach syri nge 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 and proximal infusion lumens with sterile saline. Clamp or attach injection caps to the proximal infusion lumen. 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. Insp ect the catheter for leaks.

6. Warning: Do not cut the catheter to alter length.

Catheter Insertion:

1. Obtain jugular, subclavian, or 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 Cool Line

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 indwelli ng catheter t o minimize risk of possible vessel wall perforation

6. Thread tip of Cool Line 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 c en timeter marks on the catheter as positioning reference points, advance catheter to final indwe ll ing position.

8. Hold cath eter at desired dep th 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 cat heter. If resist ance 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 a nd catheter simultaneously.

9. Caution: Do not apply undue force to the guidewire.

Catheter.

Catheter over guidewire.

Cool Line® Catheter

Instructions for Use

CL-2295A/8700-0654-01 (Also referred to as CL-2295)

10. Verify that t he guidewire is intact upon removal.

11. Check lumen placement by attaching a syringe to the distal and proximal infusion luer hubs and aspirate until a free flow of venous blood is observed. Connect infusion luers to appropriate Luer-Lock line(s) as required. Unused infusion port(s) may be "locked" through injection cap(s) using standard hospital protocol. Slide clamps are provided on the tubing to occlude flow through the infusion lumens during line and injection cap changes. Precaution: To minimize risk of damage to the tubing from excessive pressure, each clamp must be opened prior to infusing through that lumen.

12. Caution: Do not clamp or occlude inflow or outflow lines. This can cause line blockage and possible failure.

13. Secure and dress insertio n site and catheter temporarily.

14 If subclavian or jugular access is used, verify catheter

tip positio n by chest x-ray immediately after placement. X-ray exam must show the catheter located in the right side of the mediastinum in the SVC with the distal end of the catheter parallel to the ven a cava wall. The catheter distal tip must be positioned at a level above either the azygos vein or the ca rina of the trachea, whichever is better visualized. If the catheter tip is malpositioned, reposition and reverify.

15. If femoral access is used, X-ray examination 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.

16. Proximal radiopaque marker indicates proximal end of balloons to ensure that balloons reside completely in vessel. If catheter is malpositioned, reposition and reverify.

17. Secure ca theter to patient. Use juncture h u b side wings as primary suture site to minimize the risk of catheter migration.

18. The ZOLL suture tab and clip can also be used as an additional attachment point. Assure that catheter bod y is secure and does not slide.

19. Caution: Use on l y the ZOLL suture tab and clip provided in the kit. Catheter damage may result if other tabs or clips are used.

20. 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.

21. Dress puncture site per hospital protocol. Maintain the insertion site with regular meticulous redressing using aseptic technique.

22. Record on the patient's ch art the indwelling catheter length using the centimeter marks on the catheter shaft as reference. Frequent visual reassessmen t should be made to ensure that the cath eter has not moved.

23. Attach a primed Start-Up Kit to Cool Line

Heat Exchange Catheter by conn ecting the male luer of the Start-Up Kit to the female inflow luer of the Cool

Line

Catheter (labeled “inflow” ) and the fema le l uer of the Start-Up Kit to the male outflow luer of the Cool Line

Catheter (labeled “outflo w” ). White "ZOLL" tags are fitted loosely to the INFLOW and OUTFLOW extension tubes to help identify them.

4 of 11 106084-001 Rev.2

Assure that a sufficient amount of sterile saline is present at t he 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.

24. Warning: Failure to connect the Start-Up Kit correctly to the catheter could result in catheter failure. Do not attach the Start-Up Kit to the dark blue, white or brown luers.

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 connectio ns are secure and th at there is no leaking. Allow any remaining air in system to be purged out.

Disconnecting Catheter from CoolGard

/Thermogard XP® System:

3000

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

/Thermogard XP® System:

3000

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 K it to Cool Line Catheter by connecting the male luer of the S tart-Up Kit to the female inflow luer of the Cool Line

Catheter and the female luer of the Start-Up Kit to

the male ou tflow luer of the Cool Line

Heat Exchange

Catheter. Assure that a sufficient amount of sterile saline is present at t he 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 cent ral 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 the 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 sutur e site.

+ 7 hidden pages