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HEARTSTRING III Proximal Seal System
IMPORTANT: Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout
these instructions.
DESCRIPTION
The HEARTSTRING III Proximal Seal System is a device designed to enable the creation of a proximal anastomosis
of a vessel graft to the aorta without the need for an aortic clamp during coronary artery bypass graft (CABG) surgery.
The HEARTSTRING III Proximal Seal System is comprised of the Proximal Seal (Figure 1), Delivery Device (Figure 2),
Loading Device (Figure 3) and Aortic Cutter (Figure 4). The HEARTSTRING III Seal is a device that is delivered
into the aorta via an aortotomy created by the Aortic Cutter, and provides a sealed region to facilitate the proximal
anastomosis. The Delivery Device is a syringe-like tube with plunger that is used to deploy the HEARTSTRING III
Seal inside of the aorta. The Loading Device is a mechanism that rolls the HEARTSTRING III Seal and loads the
HEARTSTRING III Seal into the Delivery Device. The Aortic Cutter is a single use (one aortotomy) device that
consists of a Grip, a Cutter, Aortic Stop, a Cap, a Needle, a Safety Lock and an Actuation Button. It is used to
create the aortotomy for the anastomosis.
Anchor tab
Seal Stem
Figure 1.
Proximal Seal
Window
Figure 3.
Loading Device
INDICATIONS
The HEARTSTRING III Proximal Seal System is intended for use by Physicians during CABG procedures to
maintain hemostasis and to facilitate the completion of a proximal anastomosis to the aorta without application of
an aortic clamp.
CONTRAINDICATIONS
1.
Do not use the HEARTSTRING III Proximal Seal System in the portion of the aorta where conventional
surgical anastomosis would typically not be created due to the presence of palpable disease. Such
determination may also be based upon echocardiograms.
2.
Do not use the HEARTSTRING III Proximal Seal System on patients with aortas less than 2.5 cm in diameter.
WARNINGS AND PRECAUTIONS
•
Physicians should be properly trained prior to using the HEARTSTRING III Proximal Seal System.
•
Single Use Only. Do not re-sterilize. Single use medical devices can have extremely small and/or structurally
complex components. It can be difficult to remove blood, tissue, body fluids and pathogens from the device.
In addition, the cleaning and re-sterilization process may compromise the materials and functionality of the device.
•
Physicians should not use the HEARTSTRING III Proximal Seal System on portions of the aorta where a
partial occlusion clamp cannot be applied, to prevent patient compromise due to hemorrhage.
•
The HEARTSTRING III Proximal Seal System should not be used in patients with thin-walled aortas due to the
potential risk of the Tether (Figure 1), lacerating the side of the aortotomy.
•
When performing multiple anastomosis, ensure that all anastomotic sites are at least 1.5 cm apart to ensure hemostasis.
•
Do not re-use or resterilize the HEARTSTRING III Proximal Seal System or any of its components.
•
Do not use the HEARTSTRING III Proximal Seal System if the packaging is damaged or opened.
•
Inspect the devices to ensure no damage has occurred during transit.
•
The Aortic Cutter is a single use (one aortotomy) device. Any attempt to reuse the Aortic Cutter may result in
the introduction of air or tissue emboli into the aorta.
•
The Aortic Cutter is for use on unaltered aortic tissue only. Use on altered tissue (e.g., cardioplegia hole,
aortotomy incision) may cause the aortic plug to not be captured by the device and result in the introduction of
emboli into the aorta.
2
Tension Spring
Tether
HEARTSTRING III Seal
Protective Cap
Wing
Lock
Tube
Figure 2.
Delivery Device
Safety Lock
Aortic Stop
Figure 4.
Aortic Cutter
ENGLISH
Plunger
Handle
Actuation
Button
Grip
Cutter
Needle
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