Stryker Surpass Streamline Mode D'emploi page 4

3. Outside the patient, carefully load the Delivery Catheter onto a 0.014 in access length guidewire.
4. Under fluoroscopic guidance, carefully simultaneously advance both the Delivery Catheter and
the guidewire through the catheter until the Delivery Catheter is past the aneurysm location
5. If needed, pull the intermediate catheter back while keeping the Delivery Catheter in place
across the neck of the aneurysm.
6. Confirm the position of the Delivery Catheter by visualizing the radiopaque markers. Make sure
that the distal marker on the Delivery Catheter is at least 5 mm past the neck of the aneurysm.
Note: Pulling back on the Delivery Catheter to make final adjustments will ensure that slack has
been removed from the Delivery Catheter prior to deployment.
7. The Surpass™ Flow Diverter is now ready to be deployed.
Flow Diverter Deployment
1. Loosen the rhV on the Delivery Catheter and begin deployment by advancing the Pusher.
Visualize movement of the Pusher by means of the radiopaque marker located on the distal tip
of the Pusher.
2. Continue pushing on the Pusher until the Surpass Flow Diverter begins to exit the Delivery
Catheter. Pull back the Delivery Catheter as needed to release tension and to maintain proper
position across the neck of the aneurysm.
3. If positioning is not satisfactory, the Surpass Flow Diverter can be recaptured and repositioned.
To recapture the Surpass Flow Diverter, gently pull back on the Pusher while maintaining
forward tension on the Delivery Catheter. Once recaptured, the Delivery Catheter can be
repositioned.
Note: The Surpass Flow Diverter can be recaptured as long as approximately no more than
80% of its labeled length has been deployed, as long as the gap between catheter tip marker
and proximal pusher marker is at least 11mm.
Caution: Do not attempt to partially deploy and recapture the Surpass Flow Diverter more than
three times.
4. If the position of the Delivery Catheter is satisfactory, push the Pusher to continue exposing the
Surpass Flow Diverter. After about 10 mm of the Surpass Flow Diverter has been exposed, its
distal end will begin to flare and appose the vessel walls.
5. After the distal end of the Surpass Flow Diverter has successfully expanded and begun
apposing the vessel walls, deploy the remainder of the Surpass Flow Diverter by alternately
pushing the Pusher and pulling on the Delivery Catheter. Carefully monitor the Pusher tip under
fluoroscopy during deployment of the Surpass Flow Diverter.
6. After the entire Surpass Flow Diverter has deployed, confirm full expansion under fluoroscopy
to ensure that it has completely apposed the vessel wall.
7. retract the Pusher tip back into the Delivery Catheter by pulling on the Pusher until the
radiopaque marker on the Pusher tip is aligned with the distal radiopaque marker on the
Delivery Catheter. Tighten the Delivery Catheter RHV.
Note: While pulling back on the pusher, maintain slight forward tension on the Delivery Catheter
to prevent movement of the entire system.
8. Carefully remove the Delivery Catheter and accessories as a unit and discard.
9. Verify that the device has remained patent and properly positioned.
10. After completing the procedure, withdraw and discard all applicable accessory devices.
WARRANTY
Stryker Neurovascular warrants that reasonable care has been used in the design and manufacture
of this instrument. This warranty is in lieu of and excludes all other warranties not expressly set
forth herein, whether express or implied by operation of law or otherwise, including, but not limited
to, any implied warranties of merchantability or fitness for a particular purpose. Handling, storage,
cleaning and sterilization of this instrument as well as other factors relating to the patient, diagnosis,
treatment, surgical procedures and other matters beyond Stryker Neurovascular's control directly
affect the instrument and the results obtained from its use. Stryker Neurovascular's obligation under
this warranty is limited to the repair or replacement of this instrument and Stryker Neurovascular
shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly
arising from the use of this instrument. Stryker Neurovascular neither assumes, nor authorizes any
other person to assume for it, any other or additional liability or responsibility in connection with
this instrument. Stryker Neurovascular assumes no liability with respect to instruments reused,
reprocessed or resterilized and makes no warranties, express or implied, including but not limited
to merchantability or fitness for a particular purpose, with respect to such instruments.
Black (K) ∆E ≤5.0
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