3
Procedure
CAUTION: When placing a device using an AMPLATZER
™
TorqVue
™
LP Delivery System, refer to the instructions for use
provided with the device.
General instructions for the AMPLATZER
™
TorqVue
™
LP Delivery System are provided below.
1. Select the appropriate delivery system for the device you be will using. Refer to Table 1 to select a delivery system by
AMPLATZER
™
device size, or refer to Table 2 to select the delivery system with a catheter that has the correct inner
diameter as indicated in the device’s instructions for use.
2. Prepare the delivery system for use:
- Inspect the delivery system sterile pouch and verify that it is unopened and undamaged. Do not use the delivery
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 components with sterile saline.
- Wipe the delivery catheter with sterile gauze moistened with sterile saline to remove any foreign material.
3. Access the desired vessel.
4. Place a guidewire according to the device’s instructions for use. (A 0.035-in [0.89-mm] or 0.038-in [0.97-mm] diameter
guidewire is suggested for use with the TorqVue
™
LP delivery system.)
5. Advance the prepared delivery catheter over the guidewire until the delivery catheter is positioned according to the
device’s instructions for use.
6. Remove the guidewire. Allow back-bleeding to purge any air from the delivery catheter.
7. Flush all parts of the hemostasis valve. Connect the distal end of the hemostasis valve to the delivery catheter.
Remember to close the stopcock on the sidearm of the hemostasis valve.
8. Flush the loader with sterile saline.
9. Capture the device in the loader according to the device's instructions for use.
10. Insert the distal end of the loader into the proximal end of the hemostasis valve. Tighten the hemostasis valve to lock the
components together. Advance the device into the delivery catheter.
11. Loosen the proximal end of the hemostasis valve and remove the loader. Retighten the hemostasis valve to minimize
blood loss.
12. 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 delivery 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.
