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Abbott Amplatzer TorqVue Instructions For Use
Abbott Amplatzer TorqVue Instructions For Use

Abbott Amplatzer TorqVue Instructions For Use

Exchange systems

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TorqVue™ Exchange Systems
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.
Figure 1. AMPLATZER™ TorqVue™ Exchange System Components (45° exchange system shown)
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.
™ 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.
Instructions for Use
A
C
B
1
D
E
ARTEN600038208A
2018-08
Manufacturing facility:
Abbott Medical
5050 Nathan Lane North
Plymouth, MN
55442 USA
+1 855 478 5833
+1 651 756 5833

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Summary of Contents for Abbott Amplatzer TorqVue

  • Page 1 Contraindications None known. ARTEN600038208A 2018-08 ™ Indicates a trademark of the Abbott group of companies. Manufacturing facility: ‡ Indicates a third party trademark, which is property of its respective owner. Abbott Medical Pat. http://www.abbott.com/patents 5050 Nathan Lane North ©...
  • Page 2 Warnings • 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. • Do not use this device if the sterile package is open or damaged. •...
  • Page 3 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.
  • Page 4 Symbol Definitions The following symbols may appear on the device packaging: Symbol Definition Caution, consult accompanying documents Manufacturer Contains Phthalate EU authorized representative Reference 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...
  • Page 5 Usable length Hydrophilic coating 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...