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To recapture and remove a device:

8. Advance the delivery sheath to recapture the device within the sheath.
9. Retract the delivery cable to remove the device through the sheath.

10. Unscrew the exchange system delivery cable from the original delivery cable.

To place a new device: 

11. Attach the hemostasis valve to the loader and flush with sterile saline.
12. Capture the device in the loader according to the device's instructions for use.
13. Attach the distal end of the loader to the proximal end of the delivery sheath, and turn the rotating luer on the loader 

clockwise to lock the components together. Remember to close the stopcock on the hemostasis valve.

14. Position, deploy, and detach the device according the device’s instructions for use.

Disposal

• The instructions for use are recyclable. Dispose of all packaging materials appropriately.
• Dispose of exchange systems and accessories following standard solid biohazard 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 limited to 
replacing or repairing at its option, at its factory, this product if returned within the warranty period to Abbott Medical and after 
confirmed to be defective by the manufacturer. 
EXCEPT AS EXPRESSLY PROVIDED IN THIS WARRANTY, ABBOTT MEDICAL DISCLAIMS ANY REPRESENTATION OR 
WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY AS TO MERCHANTABILITY OR 
FITNESS FOR A PARTICULAR PURPOSE. 
See the Terms and Conditions of Sale for further information.

State of California (USA) Only:

WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to 
cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.

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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