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TorqVue
45° and 180° Delivery Systems
®
Device Description
The AMPLATZER TorqVue 45° and 180° Delivery Systems are designed to deliver AMPLATZER devices. The device and
delivery system are shipped separately. The body of the sheath is radiopaque for visibility under fluoroscopy.
Figure 1. AMPLATZER TorqVue Delivery System Components
A. Loader – Introduces an AMPLATZER device into the sheath
B. Hemostasis valve with extension tube and stopcock – Allows flushing of the delivery system and controls blood backflow
C. Sheath – Provides a pathway through which an AMPLATZER device is delivered
D. Dilator – Eases penetration of tissue and minimizes vessel trauma
E. Delivery cable – Attaches to the device to control its movement through the sheath
F. Plastic vise – Attaches to the delivery cable and serves as a handle for disconnecting (unscrewing) the delivery cable from a
device
Indications and Usage
The AMPLATZER TorqVue delivery system is intended to provide a pathway through which devices are introduced within the
chambers and coronary vasculature of the heart or in the peripheral vasculature.
Contraindications
None known.
Warnings
• Use on or before the last day of the expiration month noted on the product packaging.
• The delivery system is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to
resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
–
© 2005, 2007
2009 AGA Medical Corporation
AMPLATZER and TorqVue are trademarks of AGA Medical Corporation.
AGA Medical products and technologies for which patents are granted and/or pending in the USA
and/or other countries are listed at www.amplatzer.com/patents
Not in any way connected with medical gas or equipment sold under the "AGA" brand by AGA AB
or its successors.
Instructions for Use
1
A
B
C
D
E
F
*600266-002*
Manufacturing Facility:
5050 Nathan Lane North
Plymouth, MN 55442 USA
+1.888.546.4407 Toll Free
+1.763.513.9227 Phone
+1.763.513.9226 Fax
www.amplatzer.com
600266-002
11-2009 US
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Related Manuals for AGA Medical AMPLATZER TorqVue
Summary of Contents for AGA Medical AMPLATZER TorqVue
- Page 1 F. Plastic vise – Attaches to the delivery cable and serves as a handle for disconnecting (unscrewing) the delivery cable from a device Indications and Usage The AMPLATZER TorqVue delivery system is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Contraindications None known.
- Page 2 • Do not use the delivery system if the packaging sterile barrier is open or damaged. • The sheath is designed to be used with the loader. Do not attach a syringe directly to the sheath because the sizing is incompatible and may result in ingress of air or excessive bleeding.
- Page 3 CAUTION: Refer to the instructions for use provided with the device when placing an AMPLATZER device using an AMPLATZER TorqVue Delivery System. General instructions for the AMPLATZER TorqVue Delivery Systems are provided below. 1. Select the appropriate delivery system for use with the device being delivered. Refer to Table 1 and Table 2 to select a delivery system by AMPLATZER device size, or refer to Table 3 to select the delivery system with a sheath that has the correct inner diameter as indicated in the device’s instructions for use.
- Page 4 AGA Medical Corporation's obligation under this warranty is limited to replacing or repairing at its option, at its factory, this product if returned within the warranty period to AGA Medical Corporation and after confirmed to be defective by the manufacturer.
- Page 5 Latex free Inner diameter Outer diameter Length Usable length Recommended delivery sheath/catheter dimensions Federal law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner). Indication of conformity with the essential health and safety requirements set out in European Directives...
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