LeMaitre Vascular Over-the-Wire Mode D'emploi page 4

7. Sheath the Centering Hoops within the Protective Sheath by advancing the T-Handle until Cutting Blades are
fully enclosed and a positive stop is detected.
8. Load the device over the guidewire carefully.
9. Advance into the vein to the treatment area; 2 cm to 3 cm distal to the anastomosis.
10. Expose the Cutting Blades and Centering Hoops by maintaining the position of the Blue Handle and retracting
the T-Handle until a positive stop is detected.
Note: Failure to maintain the position of the Blue Handle while exposing cutting blades may
cause damage to the anastomosis.
11. Slowly retract the Over-the-Wire Valvulotome in the open position to disrupt valve sets.
Warning: Do not rotate the Over-the-Wire Valvulotome.
12. When the Green Safety Stripe is visible, sheath the Cutting Blades and Centering Hoops into the Protective
Sheath by maintaining the position of the Blue Handle and advancing the T-Handle.
Warning: Failure to sheath Cutting Blades and Centering Hoops prior to retracting the Over-the-
Wire Valvulotome from the vessel may cause damage.
Note: If the Over-the-Wire Valvulotome is set aside for further use within the same procedure,
device must be stored in the open position in a basin of heparinized saline. Flush device
as noted in step 6 prior to reintroduction.
13. Ligate the venous tributaries previously located and marked.
Note: Do not ligate the last major tributary until after the distal anastomosis is complete in
order to allow blood run off.
14. Pass the device through the vessel an additional 1-2 times after ligating the venous tributaries.
15. Steps 9 through 12 may be repeated as necessary. Use the LeMills Valvulotome to excise last valve set
following standard technique as needed.
Warning: A maximum of 8 passes with the Over-the-Wire Valvulotome may be completed.
16. Confirm free flow through saphenous vein using doppler.
17. Complete distal anastomosis to the appropriate arterial segment.
18. Perform a completion arteriogram using radiopaque tape to locate defects.
Storage
Store in a cool, dry place.
Re-sterilization/Repackaging
These devices are single-use only. Do not reuse, reprocess, or re-sterilize. The cleanliness and sterility of the
re-processed device cannot be assured. Reuse of the device may lead to cross contamination, infection, or patient
death. The performance characteristics of the device may be compromised due to reprocessing or re-sterilization
since the device was only designed and tested for single use. The shelf life of the device is based on single use only. If
for any reason this device must be returned to LeMaitre Vascular, place it in its original packaging and return it to the
address listed on the box.
Limited Product Warranty; Limitation of Remedies
LeMaitre Vascular, Inc. warrants that reasonable care has been used in the manufacture of this device. Except as
explicitly provided herein, LEMAITRE VASCULAR (AS USED IN THIS SECTION, SUCH TERMS INCLUDE LEMAITRE VASCULAR,
INC., ITS AFFILIATES, AND THEIR RESPECTIVE EMPLOYEES, OFFICERS, DIRECTORS, MANAGERS, AND AGENTS) MAKES
NO EXPRESS OR IMPLIED WARRANTIES WITH RESPECT TO THIS DEVICE, WHETHER ARISING BY OPERATION OF LAW OR
OTHERWISE (INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE) AND HEREBY DISCLAIMS THE SAME. LeMaitre Vascular makes no representation regarding the
suitability for any particular treatment in which this device is used, which determination is the sole responsibility of the
purchaser. This limited warranty does not apply to the extent of any abuse or misuse of, or failure to properly store, this
device by the purchaser or any third party. The sole remedy for a breach of this limited warranty shall be replacement
of, or refund of the purchase price for, this device (at LeMaitre Vascular's sole option) following the purchaser's return of
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