ZOLL IVTM Catheter Quattro User Manual

Quattro® Catheter
Quantity
English
1
Quattro®Catheter 3-Lumen
1
Vessel Dilator
1
Detachable Suture Tab & Clip
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
5cc Ampule Lidocaine HCL 1%
1
Needle Disposal Cup
1
SilvaSorb® Site Antimicrobial Dressing
1
SureSite Transparent Film Dressing
Flow rate
Priming
Guidewire Port (brown)
Medial Port (white)
Proximal Port (blue)
IC4593
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
Instructions for Use
Model IC4593/8700-0660-01
the order of a physician.
Model IC4593/8700-0660-01
Includes:
Storage:
Store between 20-25°C. Avoid freezing and excessive heat above 40°C.
United States Patent Nos.:
9.3 French x 45cm Triple Infusion Lumen Extension Line Clamps Radiopaque Polyurethane
1 Guidewires (.032” x 90cm)
1 18ga x 2 ½" (6.3cm) Radiopaque OTN Catheter
1 18ga x 2 ¾" (7.0 cm) Needle
Applause™ Coated
Device Description:
The Quattro® Heat Exchange Heat Catheter is a sterile, single use flexible catheter des igned 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 inser t io n of the (3) lumens are available for infusion and sampling.
Quattro® Catheter. Three
ml/hr
Volume
1300 ml/hr 0.6 cc
800 ml/hr 0.4 cc
1100 ml/hr 0.4 cc
Insertion Size
®
The Quattro treated. Applause is a trademark of SurModics, Inc., registered in the U.S. Patent and trademark office.
Catheter blood contact surfaces are Applause™
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.
6,749,585
Other U.S. and foreign patents pending.
Indications for Use:
The ZOLL Quattro® Catheter Mo del IC-4593, connec ted to a ZOLL Thermal Regulation System, is indicated for use:
in cardiac surgery adult patients to ach ieve and/or
maintain normothermia during surgery and recovery/i ntensive care, and
to induce, maintain and reverse mild hypothermia in
neurosurgery adult patients in surgery and recovery/i ntensive 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, on ce 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 t he catheter are essentially those 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 or active bleeding at the site of c atheter 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. Hypothe r m ia is contraindi ca te d in patients w ho 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 Disea se or Thalassem ia.
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106083-001 Rev 2
Quattro® Catheter
Instructions for Use
Model IC4593/8700-0660-01
Warnings and Precautio ns:
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 c atheter in any way. Maximum use period: 4 da ys.
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 b e us ed 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 tampon a de . Pr actitioner s pla c i ng 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 sho ul d be confirmed by x-ray after insertion. Central venous catheters should not be placed in the right atrium unless specific ally required f o r special relativ ely 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
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.
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 shoul d be placed via a femoral vein approach
only.
10. Possible complications 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 dysrhythmia.
11. All Luer-Lock connections and covers must be securely
tightened to prevent air embolism or fluid or blood loss.
12. 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.
13. Passage of t he guidewire into the right heart can cause
dysrhythmias, right bundle branch block, vessel wall, atrial or ventricular perforation.
14. Use only sterile normal sali ne for catheter p r iming and
as the circulating fluid in the ca theter.
15. 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.
16. Only x-ray examination can ensure that the cat heter tip has not ent ered the heart or no longer lies par allel 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 s yringe 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 delivere d through the Quattro rapid push of up to a concen tration 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 v ia a separate line.
22. When connecting infusion sets/injection systems to ZOLL Catheters do not ex ceed 100 psi/ 68 9 kPa.
23. Not intend ed for pediatri c o r neonatal use.
24. For patients being made hypothermic, the hypothermia itself may exa cerbate some d isease states. Care should be taken to properly monitor patient homeostasis du ring 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 PaCO should be aware that of the eff ect 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, ster ile 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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®
Catheter except for
. Physicians
2
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 C oolGard 3000
®
XP
2. Disconnect the Start-Up Kit from the catheter and
3. Fill a sterile 10 ml syringe with sterile saline.
4. Connected to the INFLOW lumen of the catheter and
5. Now cap the OUTFLOW lumen and pull 5 cc of
6. Ease the vacuum and recap the INFLOW lumen.
To check the integrity of the tubing set:
1. Look for obvious leaka ge.
2. Remove the tubing from the pump raceway and inspect
3. Check along the tubing from the pump to the patient for
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.
System.
properly cap both the catheter and Start-Up Kit using an aseptic technique.
disconnect the outflow cap. Infuse the 10 ml of saline – it should flow out the outflow lumen.
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.
for damage (return it to position if not damaged).
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 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).
Materials Required:
Quantity Description
®
1 Quattro 1 Bag of Normal Saline 1 Start-Up Kit 1 CoolGard 3000
Kit for percutaneous introduction
®
Catheter Preparation and Insertion:
Use sterile technique.
1. Caution: Use f e moral vein app r oach 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 rem ove 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
®
/Thermogard
/Thermogard XP® System
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 infusion lumen with sterile saline. Leave the dist al 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 ca theter to assure that air has been p urged from the heat exchange membrane. Inspect the catheter for leaks.
6. Warning: Do not cut the catheter to alter lengt h .
Catheter Insertion:
1. Obtain femoral venous access using standard percutaneous techniques. Access should be mainta i ne d with a .032" guidewire. See sp ecial 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
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 wit h cutting edge of scalpel positioned away from the guidewire. Warning: Do not cut guidewire. Use v essel dilato r 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 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 p o ints, advance catheter to fina l indwelling position.
8. Hold catheter at desired depth and remove gu idewire. If resista n ce is encountered when attempting to remove the guidewi r e after cathet er 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 guidewi r e. 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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®
Catheter.
®
over guidewire. Maintain a
106083-001 Rev 2
Quattro® Catheter
Instructions for Use
Model IC4593/8700-0660-01
infusion lum en during line a n d injection ca p changes. Precaution: To minimize risk of dam age 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 insertio n site and catheter temporari l y.
14 Verify 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 ca theter to patient. Use juncture h u b 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 bod y is secure and does not slide.
18. 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.
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 reassessmen t should be made to ensure that the cath eter has not moved .
22. Attach a primed Start-Up Kit to Quattro Exchange Catheter by conn ecting the male luer o f the Start-Up Kit to the female inflow luer of the Quattro catheter and the female luer o f the Start-Up Kit to the male outflow luer of the Quattro 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 t he ends of the hubs to make an air free connection. Refer to CoolGard 3000
®
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 s ecure and that ther e is no leaking. Allow any remaining air in system to be purged out.
®
Heat
®
Catheter. White "
®
/Thermogard
®
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 Quattro Catheter by connecting the male luer of the S tart-Up Kit to the female inflow luer of the Quattro and the fema l e luer of the Start-Up Kit to the male outflow luer of the Quattro 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 cent ral line infusion ports. They are for connection to the CoolGard 3000
5. Caution: Do not place any extra stopcocks in line that may be inadvertently shut off. This can cause line blockage and possible failure.
®
/Thermogard XP® System ONLY.
®
Heat Exchange
®
Catheter. Assur e that a
Catheter Removal:
1. Stop all pumping of saline through the catheter.
2. Disconnect Start-Up Kit from ca theter. Uncap or leave
uncapped the inflow and outflow lumens of the cooling circuit (coo lin g ci rcu it ON L Y ) . This will
allow residual saline within the circuit to be expressed. As catheter is withdrawn, the balloons are compressed. Saline within the balloon s 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.
4. Slowly remove catheter from patient. As catheter exits the site apply pressure with a dressing imp er meable to air, e.g. v aseline 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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®
Catheter
106083-001 Rev 2
Quattro® Catheter
Instructions for Use
Model IC4593/8700-0660-01

Special Instructions for Guidewires

Note: This information applies only to the use of guidewires in the Seldinger technique of catheter placement in the vasculature.
Note: This procedure should be performed only after a thorough review of technical references, wh ich emphasize precautions, contr aindications, and risks in much greater detail.
This spring guidewire was designed for single patient – one time use only.
It is recommended that guidewires be discarded after one use. No cleaning agents or techniques will complet el y remove residual material from the guidewire after use.

INSPECTION

Guidewires should be routinely inspected prior to use and discarded should any deformities be present in the guidewire.
Guidewire placement should be routinely monitored by x-ray or fluoroscopic procedure.

CAUTIONS

Because of the delicate and f ragile nature of guidewires, extra care in handling must be taken. Avoid bending or kinking.
During storage or procedures avoid coiling guidewires in less than 8-inch diameters as smaller diameters place unnecessary stress on the guidewires. The provided dispenser is the best means of storage and handling of the guidewire.
Should resistance occur during insertion, DO NOT advance guidewire.
Avoid withdrawing guidewire through me ta l needles; guidewires may shear or PTFE coating may scrape off against the needle bevel.
Movable core of guidewire should not be advanced while guidewire is in patient as this could cause damage to the guidewire and possible injury to the vessel.
Sufficient guidewire length must remain exposed to maintain firm grip on guidewires at all times.
PTFE coated guidewires must never be subject to ultra-sonic cleaning or irradiation sterilization.

TECHNIQUE

1. PUNCTURE VESSEL
Needle Cannula in Vessel
motion is sufficient to traverse an obstruction. Avoid rough or overly vigorous manipulation of the guidewire to prevent d amage to the guidewire or the vessel.
If “J” wire is used, prepare “J” guidewire by sliding the plastic insert io n sl e eve over “J” tip to str aighten it. Insert the “J ” guidewire into the needle hub and gently advance it.
Guidewire in V essel
3. REMOVE
Needle Remov ed from Guidewire
4. DILATE TISSUE AND VESSEL WITH THE DILATOR USING A SLIGHT ROTARY MOTION.
5. REMOVE DILATOR. (Vessel dilator intend ed for vascular dilation onl y.)
6. INTRODUCE CATHETER BY SLIDING IT OVER THE GUIDEWIRE.
2. Pass the guidewire thro ug h t he needle and adv a n ce
5-10cm of the guidewire into the punctured vessel. It may be necess ary to manipula te the guidewire in order to successfully advance it. Usually a gentle, rotating
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106083-001 Rev 2
7. REMOVE GUIDEWIRE.
FIG. 2
Quattro® Catheter
Instructions for Use
Model IC4593/8700-0660-01

DISPENSER

Every guidewire is provided in a u ni que dispense r package. It is recommended that the dispenser be filled with heparinized solutions. (e.g. saline or dex trose) to bat he the guidewire during insertion (Figure 2).
Preformed “J” guidewire will resum e shape when remov ed from product dispenser.
FIG.1
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106083-001 Rev 2
Quattro® Catheter
Instructions for Use
Model IC4593/8700-0660-01

Quattro Model IC4593 Manifold and Distal Configuration

Shaft

Balloons

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106083-001 Rev 2
Quattro® Catheter
Instructions for Use
Model IC4593/8700-0660-01
MRI Information . The following models of the ZOLL Heat Exchange Catheters have been determined to be MR-Conditional (formerly classi fied as MRI-safe) according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-05. Standard Practice for Marking M ed ical Devices and O ther Items for Saf ety in the Magnetic Resonance Environment. ASTM International, 100 Barr Harbor D rive, PO Box C700, West Conshohock en, Pennsylvania, 2005.
1. Cool Line
2. Icy
3. Quattro

Non-clinical testing demonstrated that these catheters are MR Conditiona l . A patient with this implant can b e scanned safely immediately after placement under the following conditions:

Magnetic Field Interactions
For magnetic field interactions,

-Static magnetic field of 1.5-Tesla or less

-Maximum spatial gradient magnetic field of 2.4 Tesla/meter or less

MRI-Related Heating
In non-clinical testing, these catheters produced the following temperature rises during MRI performed for 20-min in 1.5-Tesla (1.5-Tesla/64-MHz, General electric Medical Systems, Milwaukee, WI) MR systems, as follows:
Highest temperature change MRI Condition
+0.6˚C 1.5-T/64-MHz
Therefore, the MRI-related heating experiments for these catheters at 1.5-Tesla using a transmit/receive RF body coil at MR system reported whole body averaged SARs of 2.0-W/kg, indicated that the greatest amount of heating that occurred in association with these specific conditions was equal to or less than 0.6˚C at 1.5-Tesla.
Artifact Information
MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of these catheters. The artifact size information is, as follows:
Pulse sequence T1-SE T1-SE GRE GRE
Signal Void Size <1,106-mm
®
®
®
2
<25-mm2 <1,857-mm2 <60-mm
2
Imaging Plane parallel perpendicular parallel perpendicular
Therefore, optimiza tion of MR imaging parameters to compensate for the presence of thes e catheters ma y be necessary.
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Quattro® Catheter
Instructions for Use
Model IC4593/8700-0660-01
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Quattro® Catheter
Instructions for Use
Model IC4593/8700-0660-01
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Quattro® Catheter
Quattro
Instructions for Use
Model IC4593/8700-0660-01
Silva Sorb Site Dressing
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