Amplatzer TorqVue LP Gebrauchsanweisung Seite 4

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AMPLATZER TorqVue
Instructions for Use
Device Description
The AMPLATZER TorqVue LP Delivery System consists of a delivery catheter, loader, hemostasis
valve, plastic vise, and delivery wire. The delivery system was designed specifically to facilitate
attachment, loading, delivery, and deployment of specified AMPLATZER implantable devices.
The delivery catheter is radiopaque for visibility when using fluoroscopy. The catheter delivery
system consists of the following components:
A. Delivery wire – allows placement and recapture of the implantable device
B. Hemostasis valve – adapter with extension tube and stopcock
C. Plastic vise – can be attached to the delivery wire, serving as a "handle" for disconnecting
(unscrewing) the delivery wire from the implantable device
D. Loader – used to introduce the implantable device into the delivery catheter
E. Delivery catheter – catheter used to deliver the device
A
C
Figure 1. AMPLATZER TorqVue LP Delivery System components
Intended Use
The AMPLATZER TorqVue LP Delivery System is intended to facilitate the attachment, loading,
delivery, and deployment of the AMPLATZER devices.
Indications for Use
The TorqVue LP Delivery System is indicated for use by interventional cardiologists to place an
AMPLATZER device.
Contraindications
None
Warnings
• Do not use the device if the sterile barrier is open or damaged.
Precautions
• The delivery system has not been tested with devices other than AMPLATZER devices. If
the delivery system is used with incompatible devices, the user may be unable to deliver the
transvenous device, or the transvenous device may be damaged during delivery.
• For single use only. Do not reuse or resterilize.
• Store in a dry place.
• Use before the expiration date noted on the product packaging.
• Use a 0.035 inch (0.089 cm) guide wire when accessing the defect.
• Use the hemostasis valve to impede the back-flow of blood during the implant procedure.
• Use the side-port on the hemostasis valve to flush the delivery catheter with sterile saline
solution to purge all air prior to use.
• Do not use a power injection syringe to inject contrast solution.
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LP Delivery System
D
B
E
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