3
Directions for Use
Materials recommended for use with the delivery system
Exchange-length 0.035-inch guidewire
Procedure
CAUTION: When placing a device using an Amplatzer™ Trevisio™ Intravascular Delivery System, refer to the
instructions for use provided with the device.
General instructions for the Amplatzer™ Trevisio™ Intravascular Delivery System are provided below.
1. Select the appropriate delivery system for use with the device being delivered. 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 sheath that has the correct
inner diameter as indicated in the device’s instructions for use.
2. Prepare the delivery system 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 all components with sterile saline.
- Wipe the dilator and sheath with sterile gauze moistened with sterile saline to remove any foreign material.
3. Access the desired vessel.
4. Place the guidewire according to the device’s instructions for use.
5. Insert the dilator into the sheath. You may encounter resistance as the dilator reaches the distal end of the sheath
because the end of the sheath is tapered.
6. Turn the rotating luer on the dilator clockwise to lock the components together.
7. Advance the dilator and sheath over the guidewire until the sheath is positioned according to the device’s instructions for
use.
8. Turn the rotating luer on the dilator counterclockwise to unlock the dilator. Slowly remove the dilator from the sheath.
WARNING: Remove the dilator slowly to prevent an ingress of air.
9. Allow blood backflow to purge any air from the sheath.
10. Attach the hemostasis valve to the proximal end of the loader and flush with sterile saline.
CAUTION: Use the hemostasis valve to impede blood backflow during the implant procedure.
11. Capture the device in the loader according to the device's instructions for use.
12. Attach the distal end of the loader to the proximal end of the sheath. Turn the rotating luer on the loader clockwise to lock
the components together. Remember to close the stopcock on the hemostasis valve.
13. Advance the device until the black mark reaches the hemostasis valve, indicating the Amplatzer™ device is near the end
of the delivery system.
WARNING: When the black mark reaches the hemostasis valve, some devices and device sizes may be closer to the
end of the delivery system due to differences in device, sheath, and loader lengths. Advancing the device without
fluoroscopy may result in patient injury.
14. Position, deploy, and detach the device according the device’s instructions for use.
Table 2. Delivery System Dimensions
Delivery system
(sheath) size
Inner diameter of
sheath
Outer diameter of
sheath
Model Number/Delivery
System Size (mm)
6 Fr
2.11 mm (0.08 in)
2.79 mm (0.11 in)
9-ATV06F45/60
7 Fr
2.44 mm (0.10 in)
3.18 mm (0.13 in)
9-ATV07F45/60
7 Fr
2.44 mm (0.10 in)
3.18 mm (0.13 in)
9-ATV07F45/80
8 Fr
2.69 mm (0.11 in)
3.45 mm (0.14 in)
9-ATV08F45/60
8 Fr
2.69 mm (0.11 in)
3.45 mm (0.14 in)
9-ATV08F45/80
9 Fr
3.00 mm (0.12 in)
3.81 mm (0.15 in)
9-ATV09F45/80
10 Fr
3.30 mm (0.13 in)
4.14 mm (0.16 in)
9-ATV10F45/80
12 Fr
3.99 mm (0.16 in)
4.80 mm (0.19 in)
9-ATV12F45/80
