Amplatzer Torqvue Exchange System Instructions For Use - Amplatzer TorqVue Instrucciones De Uso

AMPLATZER ® TorqVue™ Exchange System
Instructions for Use
Intended Use
The AMPLATZER TorqVue™ Exchange System is intended for removal of an AMPLATZER Delivery
®
Sheath and subsequent exchange for an AMPLATZER Delivery Sheath of equal or larger diameter.
Description
The AMPLATZER TorqVue Exchange System or "Bail out" mechanism is a delivery system
especially adapted for use in conjunction with the AMPLATZER family of occlusion devices. The
system components are identical to the AMPLATZER TorqVue Delivery System, with the exception
of the dilator, which incorporates an enlarged inner lumen for passage over a delivery cable.
The AMPLATZER TorqVue Exchange System incorporates the following elements:
A. Delivery Sheath - used to deliver an AMPLATZER Occluder device
B. Touhy-Borst Adapter - used to prevent blood reflux and air aspiration
C. Dilator - used to ease penetration of tissue
D. Loading Device - used to introduce an AMPLATZER occluder into the delivery sheath
E. Plastic Vise - facilitates direction control and serves as the "handle" for disconnecting
(unscrewing) the delivery cable from the device
F. Delivery Cable - allows for placement (and if necessary, retrieval) of the device
PLASTIC
VISE
SCREW-ON
CAPSULE
Precautions and Warnings
1. Store in a dry place.
2. Do not use if package is open or damaged.
3. Use prior to "Use By" date on the label.
4. Do not expose to organic solvents.
5. Ethylene Oxide sterilized for single use. Do not reuse or resterilize.
6. If strong resistance is met during manipulation, discontinue the procedure and determine the
cause of resistance before proceeding. If the cause of the resistance cannot be determined,
withdraw all components.
COMBINATION TOUHY
BORST/HEMOSTASIS VALVE
LOADER
DELIVERY SHEATH
1-WAY STOP COCK
1
DELIVERY CABLE