How Supplied; Warranty Disclaimer - Medtronic Solitaire X SFR4-4-20-05 Gebrauchsanweisung

NOTE: If withdrawal into the guide catheter is difficult, deflate balloon (if using balloon guide catheter) and then
simultaneously withdraw guide catheter, microcatheter and Solitaire™ X Revascularization Device as a unit through
the sheath while maintaining aspiration. Remove sheath if necessary.
WARNINGS
• If excessive resistance is encountered during recovery of the Solitaire™ X Revascularization Device, discontinue the
recovery and identify the cause of the resistance.
• For vessel safety, do not perform more than three recovery attempts in the same vessel using the Solitaire™ X
Revascularization Device.
24. Open the guide catheter RHV to allow the Solitaire™ X Revascularization Device to exit without resistance. Use care to
avoid interaction with the site of the intervention and to prevent air from entering the system. If applicable allow the
microcatheter and the Solitaire™ X Revascularization Device to exit without resistance.
25. Aspirate the guide catheter to ensure the guide catheter is clear of any thrombus material.
26. Deflate guide catheter balloon if using balloon guide catheter.
27. If additional flow restoration attempts are desired with:
a. A new Solitaire™ X Revascularization Device, then:
i. Repeat the steps described above starting with the "Preparation" section.
b. The same Solitaire™ X Revascularization Device, then:
i. Clean the device with saline solution.
Note: Do not use solvents or autoclave.
ii. Carefully inspect the device for damage. If there is any damage, do not use the device and use a new
Solitaire™ X Revascularization Device for subsequent flow restoration attempts following the steps
described above starting with the "Preparation" section. Use of a damaged device could result in
additional device damage or patient injury.
WARNING
• For device safety, do not use each Solitaire™ X Revascularization Device for more than three flow restoration
recoveries.

HOW SUPPLIED

The Solitaire™ X Revascularization Device is provided sterile for single patient use only.
Sterile:
This device is sterilized with Ethylene Oxide. Non-pyrogenic.
Contents:
One (1) Solitaire™ X Revascularization Device.
Storage: Store product in a dry, cool place.

WARRANTY DISCLAIMER

Although this product has been manufactured under carefully controlled conditions, the manufacturer has no control over
the conditions under which this product is used. The manufacturer therefore disclaims all warranties, both expressed and
implied, with respect to the product including, but not limited to, any implied warranty of merchantability or fitness for
a particular purpose. The manufacturer shall not be liable to any person or entity for any medical expenses or any direct,
incidental or consequential damages caused by any use, defect, failure or malfunction of the product, whether a claim for
such damages is based upon warranty, contract, tort or otherwise. No person has any authority to bind the manufacturer
to any representation or warranty with respect to the product. The exclusions and limitation set out above are not intended
to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this
Disclaimer of Warranty is held illegal, unenforceable or in conflict with applicable law by a court of competent jurisdiction,
the validity of the remaining portions of this Disclaimer of Warranty shall not be affected, and all rights and obligations
shall be construed and enforced as if this Disclaimer of Warranty did not contain the particular part or term held to be
invalid.
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