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INFUSION CATHETER
I N S T R U C T I O N S F O R U S E
Figure 1: Catheter Assembly
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Cartridge
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Injection Port
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Guide Wing
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Catheter Sheath
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Rotatable Dispersion Wire
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Dispersion Wire Tip
Figure 2: Motor Drive Unit
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Mating Alignment Channel Position 1
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Speed Selector
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Syringe Locking Support
10. Trigger
11. Mating Alignment Channel Position 2
12. Battery Terminal Insulator Tab
13. Green Indicator Light
Figure 3: Catheter Assembly with Check Valve and Syringe
14. Check Valve
15. Syringe 5 mL
Figure 4: Connected Catheter Assembly with MDU
Position 1
: Caution - Federal Law (USA) restricts this device to sale by or on the order of a physician.
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is
damaged. If damage is found, call your company representative. Inspect prior to use to verify that
no damage has occurred during shipping. For single patient use only. Do not reuse, reprocess or
resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the
device and/or lead to device failure, which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or
cause patient infection or cross-infection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death
of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or local
government policy.
DEVICE DESCRIPTION
The ClariVein® OC is a specialty infusion catheter with 360˚ Rotatable Dispersion Wire connected to
a proximally located integral battery powered Motor Drive Unit (MDU). The MDU includes the Speed
Selector, handle grip and Syringe Locking Support features to facilitate physician-controlled infusion
of the selected agent. The ClariVein® OC is introduced through a microintroducer. Utilizing vascular
imaging, the coaxial Catheter Sheath with Dispersion Wire is navigated through the vasculature to
the treatment site. Fluid delivered through the Catheter Assembly's Check Valve and Injection Port
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Position 2
English
surrounds the Dispersion Wire and exits via an opening at the distal end of the catheter. The ClariVein®
OC has no user serviceable parts or capital equipment. It is fully disposable.
CONTENTS
1 ClariVein® OC
1 Syringe 5 mL
INDICATIONS FOR USE
The ClariVein® OC is indicated for infusion of physician-specified agents in the peripheral vasculature
including for endovascular occlusion of incompetent veins in patients with superficial venous reflux.
INTENDED USE
The ClariVein® OC is intended for the infusion of physician-specified agents in the peripheral
vasculature.
CONTRAINDICATIONS
The ClariVein® OC is not intended for use in the following:
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Coronary and cerebral vasculature
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Pulmonary vasculature
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Diseased and atherosclerotic arteries
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Infusion of blood and blood products
WARNINGS
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This product should be used by physicians that have a thorough understanding of intravascular
ultrasound, angiography, peripheral vascular procedures and anatomy.
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Prior to use, carefully examine the ClariVein® OC and package contents included with ClariVein®
OC and verify they have not been damaged during shipment. If the components show any sign of
damage DO NOT USE.
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After use, dispose of the product per institutional protocol.
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Due to the risk of exposure to HIV or other blood borne pathogens, health care workers
should always use standard blood and body fluid precautions in the care of all patients. Sterile
techniques should be strictly adhered to during any handling of the device.
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Do not modify the device. To do so could result in injury, illness, or death.
CAUTIONS
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Do not use the ClariVein® OC in patients contraindicated for endovascular procedures.
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Do not use without completely reading and understanding the instructions for use.
NOTE: Packaging contents contains no medications. Prior to use, carefully read and understand
the respective manufacturer's instructions for procedural accessory devices and solutions
intended for use including warnings, cautions, potential side effects and contraindications.
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Before using ClariVein® OC, verify proper function and integrity of the device.
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Refer to package label for expiry date and do not use after expiration.
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Rotation of the ClariVein® OC Dispersion Wire is internally powered via a 9V DC battery. Prior to
use of the device, remove the Battery Terminal Insulator Tab by pulling tab away from device.
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The integral 9V, DC battery is not intended to be either removed or replaced.
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Do not use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous
oxide in order to reduce any potential of static discharge or other ignition hazards.
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Select an appropriately sized vascular access device.
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Failure to use a compatible access device may result in damage to the device or cause patient
injury.
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Confirm syringe and Check Valve connections. Do not use if a leak persists.
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Manipulate the catheter in the vessel only under vascular imaging.
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Do not exert excessive force when withdrawing or advancing catheter. If resistance is
encountered, determine if remedial action is necessary. Failure to do so may result in device
damage or patient injury.
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Utilize vascular imaging such as ultrasound to confirm that the catheter tip is in the desired
location before activation of Dispersion Wire rotation.
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When mating the MDU onto the Catheter Assembly Cartridge do not bend or kink the Dispersion
Wire. To do so could cause damage to the device or patient injury.
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Slowly withdraw the device through the treatment area after Dispersion Wire activation. A draw
rate of approximately 1-2 mm/second is recommended while simultaneously infusing fluid.
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Potential fatigue failure of the ClariVein® OC Dispersion Wire may occur with prolonged activation
of the device, which could result in device breakage.
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Prior to the Dispersion Wire rotation activation, confirm that the Catheter Assembly Cartridge is
securely mated in Position 2 in the MDU to avoid damage to the device and/or patient injury.
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Do not advance the Catheter Assembly when the Catheter Assembly Cartridge is mated to the
MDU and is in Position 2.
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Upon completion of the infusion procedure, prior to removal of the ClariVein® OC, move the
Catheter Assembly Cartridge to Position 1 in the MDU to avoid damage to the device and/or
patient injury.
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The Catheter Assembly and Motor Drive Unit cannot be separated after the Catheter is moved to
Position 2.
ADVERSE EVENTS
Potential adverse events that might be encountered during a peripheral vasculature infusion
procedure using the ClariVein® OC are similar to those associated with any interventional procedure
and include, but are not limited to, the following:
1.
Abrupt thrombosis and occlusion of the treated vessel
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Bleeding from the site of access
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Vascular rupture and perforation
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Vascular dissection
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Hemolysis
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Hematoma
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Neurological deficits including stroke and death
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Embolization
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Reaction to infused substances
10. Pain
11. Pseudoaneurysm
12. Hypotension, Hypertension
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