Directions For Use - Amplatzer TorqVue 2 Delivery Sheath Instrucciones De Uso

Device Compatibility
Refer to the instructions for use provided with the device to determine delivery sheath
compatibility.

Directions for Use

Materials recommended for use with the delivery sheath:
• 0.035-inch guidewire
• Hemostasis valve
Procedure
CAUTION: When placing a device using an AMPLATZER TorqVue 2 Delivery Sheath, refer to
the instructions for use provided with the device.
1. Select the appropriate size delivery sheath for the device that will be introduced
through the sheat
appropriate device size.
2. Place a 0.035-inch guidewire according to the device's instructions for use.
3. Prepare the components for use:
- Inspect the sterile pouch and verify that it is unopened and undamaged. Do not use
the components 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 the components with sterile saline.
- Wipe the dilator and sheath with sterile gauze dampened with sterile saline to
remove any foreign material.
4. Insert the dilator into the sheath. You may encounter resistance as the dilator reaches
the distal end of the sheath because the tip of the sheath is tapered.
5. Turn the rotating luer on the dilator clockwise to lock the components together.
6. Advance the dilator and sheath over the guidewire.
7. Turn the rotating luer on the dilator counterclockwise to unlock the components.
Remove the dilator from the sheath.
WARNING: Remove the dilator slowly to prevent an ingress of air.
8. Remove the guidewire.
9. Connect a hemostasis valve to the sheath to prevent excessive bleeding or air
embolism.
10. Deliver the device according to the device's instructions for use.
11. When the procedure is complete, remove the sheath.
WARNING: Remove the sheath slowly to prevent an ingress of air.
Disposal
• The IFU is recyclable.
• Dispose of all packaging materials as appropriate.
• Dispose of delivery systems and accessories per standard solid biohazard waste
procedures.
Warranty
AGA Medical Corporation 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. 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.
h. See table T1 on the foldout of the back cover to determine the
2