Merit Medical HERO GRAFT Mode D'emploi page 9

13. To ensure complete closure of the Adapter clamshells, firmly clamp with a straight serrated vascular clamp (see image below).
NOTE: Ensure the hinge of the clamshells is facing away from the hinge of the straight serrated vascular clamp (see image below).
Caution: Do NOT lock the straight serrated vascular clamp on the Adapter.
Caution: The Adapter should be placed at the center of the serrated jaws to avoid accidental locking of the clamps.
Caution: Do not clamp directly on the hinge of the Adapter clamshells.
Adapter
Hinge Pin
WARNING: There is a risk of device failure if the clamshells are not fully closed. Be sure to deliberately clamp the clamshells tightly to ensure full
closure.
14. The Adapter with graft assembly is now ready for implant.
IMPLANTING THE GRAFT
1. Make an incision at the selected arterial anastomosis site. Using a standard vessel loop, expose the artery and verify the ID is greater than 3mm in
size. Verify patency via Doppler or tactile feel.
Caution: Use of the HeRO Graft was clinically studied using the brachial artery. Arterial implantation of the device to other
arteries has NOT been studied and may increase the risk of adverse events not encountered in the clinical trial. However,
identification of an alternative artery with an ID of 3mm or greater may result in improved blood flow compared to a
brachial artery with an ID of less than 3mm.
2. For grafts that are used with the Adapter and Support Seal (if applicable), consult the manufacturer Instructions for Use for proper tunneling
and implantation.
3. Leave approximately 8cm of the graft exposed at the DPG incision site to facilitate the connection from the graft to the Venous Outflow
Component.
4. Cut the graft from the tunneler and use a standard vascular clamp to occlude the graft at the anastomosis site.
CONNECTING THE HeRO GRAFT
1. Place a sterile 4x4 gauze pad between the Venous Outflow Component and the DPG incision site to prevent debris from contaminating the
incision.
2. Determine the Venous Outflow Component length required to make the connection to the graft at the final DPG location. Make a straight cut
using heavy duty scissors.
Caution: DO NOT test fit the Venous Outflow Component onto the Adapter's Venous Outflow Component end as it was designed not to
separate once connected.
3. Hold the Venous Outflow Component 2cm from the cut end and advance it over both barbs and up to the Adapter shoulder.
NOTE: Avoid kinking or compressing the coil portion of the Support Seal during connection.
Caution: The HeRO Graft Venous Outflow Component was designed to engage both barbs of the connector tightly so that the pieces
do not separate. If separation is necessary, a new straight cut should be made to the Venous Outflow Component near the
Adapter. Special care should be taken when trimming and removing the excess Venous Outflow Component piece from the
Adapter. Clean the Adapter of any material or residue. If damage occurs to the Adapter during separation, a new device
should be used. Use fluoroscopy to recheck radiopaque tip placement after any adjustment is made.
ENGLISH
Adapter
Hinge Pin
No Support Seal
With Support Seal
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