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Manufacturing facility:
Abbott Medical

5050 Nathan Lane North   
Plymouth, MN 
55442 USA
+1 855 478 5833
+1 651 756 5833

ARTEN600038208A

2018-08

™ Indicates a trademark of the Abbott group of companies. 
‡ Indicates a third party trademark, which is property of its respective owner.
Pat. http://www.abbott.com/patents
© 2018 Abbott. All Rights Reserved.

Description

The AMPLATZER™ TorqVue™ Exchange Systems consist of a delivery sheath, dilator, loader, hemostasis valve, delivery 
cable, and plastic vise. The system components are identical to the AMPLATZER™ TorqVue™ Delivery System except that the 
dilator has a larger inner lumen to allow passage over a delivery cable. The body of the delivery sheath is radiopaque for 
visibility under fluoroscopy. 

A. Delivery sheath – Provides a pathway through which a device is delivered.
B. Loader – Introduces a device into the delivery sheath.
C. Hemostasis valve with extension tube and stopcock – Allows flushing of the exchange system and controls back-bleeding.
D. Delivery cable – Attaches to an in vivo delivery cable to facilitate removal of a delivery sheath from a patient. Attaches to a device 

for controlling its movement through the delivery sheath.

E. Plastic vise – Attaches to the delivery cable, serving as a “handle” for detaching (unscrewing) the delivery cable from a device.
F. Dilator (not pictured) – Eases penetration of tissue.

Indications for Use

The AMPLATZER™ TorqVue™ Exchange System is intended for removal of a delivery sheath and subsequent exchange with a 
delivery sheath of equal or larger diameter.

Contraindications

None known.

Figure 1.  AMPLATZER

 TorqVue

 Exchange System Components (45° exchange system shown)

A

C

D

B

E

TorqVue™ Exchange Systems

Instructions for Use

Summary of Contents for Amplatzer TorqVue

Page 1: ...ath Provides a pathway through which a device is delivered B Loader Introduces a device into the delivery sheath C Hemostasis valve with extension tube and stopcock Allows flushing of the exchange system and controls back bleeding D Delivery cable Attaches to an in vivo delivery cable to facilitate removal of a delivery sheath from a patient Attaches to a device for controlling its movement throug...

Page 2: ...ral instructions for the AMPLATZER TorqVue Exchange Systems are provided below 1 Prepare the exchange system for use Inspect the exchange system sterile pouch and verify that it is unopened and undamaged Do not use the exchange system if the sterile barrier has been compromised Gently open the sterile pouch and inspect the components for damage Do not use damaged or kinked components Flush all com...

Page 3: ...zard waste procedures Warranty Abbott Medical warrants to buyer that for a period equal to the validated shelf life of the product this product shall meet the product specifications established by the manufacturer when used in accordance with the manufacturer s instructions for use and shall be free from defects in materials and workmanship Abbott Medical s obligation under this warranty is limite...

Page 4: ...ence number Product serial number Batch Code Use by date Use on or before the last day of the expiration month noted on the product packaging Do not reuse Sterilized using ethylene oxide Unique device identification Consult instructions for use Follow instructions for use on this website Keep dry Do not use if package is damaged Not made with natural rubber latex Inner diameter Outer diameter Leng...

Page 5: ...ting 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 Quantity Date of manufacture Exchange System ONLY Exchange System ...

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