Publicidad
Idiomas disponibles
Idiomas disponibles
AMPLATZER™ TorqVue™ LP Delivery System
en: 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.
Refer to the figures and tables in Appendix A: Supplemental Information for more information
about the device. Device dimensions are provided in table T1. The following device
components are identified in figures F1 and F2:
A. Plastic vise – can be attached to the delivery wire, serving as a "handle" for disconnecting
(unscrewing) the delivery wire from the implantable device
B. Delivery wire – allows placement and recapture of the implantable device
C. Hemostasis valve – adapter with extension tube and stopcock
D. Loader – used to introduce the implantable device into the delivery catheter
E. Delivery Catheter – catheter used to deliver the device
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 known.
Warnings
• Do not use this device if the sterile package is open or damaged.
• This device should be used only by physicians who are trained in standard
transcatheter techniques. The physician should determine which patients are
candidates for procedures that use this device.
• Slowly remove the sheath from the patient to prevent the introduction of air.
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.
• This device was sterilized with ethylene oxide and is for single use only. Do not reuse or
resterilize this device. Attempts to resterilize this device can cause a malfunction,
insufficient sterilization, or harm to the patient.
• Use on or before the last day of the expiration month that is printed on the product
packaging label.
• 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.
1
Publicidad
