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Pre-Use Check
Inspect blades for damage and alignment prior to use.
Instructions for Use
1.
Cut the first valve under direct vision using standard technique.
2.
Perform the proximal anastomosis to distend the vein.
3.
With the LeMaitre Valvulotome in the open position, remove the Irrigation Port cap and flush with sterile heparinized saline.
Replace the cap upon completion.
4.
Sheath the Centering Hoops within the Protective Sheath by advancing the White Handle until the Cutting Blades are fully
enclosed and a positive stop is detected.
5.
Activate the hydrophilic coating of the device by:
a) placing the LeMaitre Valvulotome into a basin with enough sterile saline to cover the device, or
b) by wiping the Protective Sheath with sterile saline.
6.
Advance the device into the vein to the treatment area; 2 cm to 3 cm distal to the anastomosis.
7.
Expose the Cutting Blades and Centering Hoops by maintaining the position of the Green Handle and retracting the White
Handle until a positive stop is detected.
Note:
Failure to maintain the position of the Green Handle while exposing the Cutting Blades may cause damage to the
anastomosis.
8.
Slowly retract the device in the open position to disrupt the valve sets.
Warning:
Do not rotate the LeMaitre Valvulotome.
9.
Proceed with caution until the Green Safety Stripes appear. These stripes indicate the 2 cm end of the Protective Sheath.
When the third (and final) Green Safety Stripe is visible, sheath the Cutting Blades and Centering Hoops into the Protective
Sheath by maintaining the position of the Green Handle and advancing the White Handle.
Warning:
Failure to sheath the Cutting Blades and Centering Hoops prior to retracting the device from the vein may cause
damage.
Note:
If sheathing the Cutting Blades for vein extraction leaves the most distal valve set intact, use the LeMills
Valvulotome to excise using standard technique.
Note:
If the device is set aside for further use within the same procedure, it must be stored in the open position in a basin
of heparinized saline. Flush the device as noted in step 3 prior to reintroduction.
10.
Pass the device through the vein an additional 1-2 times.
11.
Steps 5 through 9 may be repeated as necessary.
12.
Confirm the free flow of blood through the vein.
Storage
Store in a cool, dry place.
Resterilization/Re-use
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.
Safe Handling and Disposal
This device is single-use and disposable device. Do not implant. Please return the used device only at the time that
the device has not performed as intended or the device is related to an adverse event. In other situations, the device
should not be returned but disposed accorded to local regulations.
Black Depth
Green Safety
Markers
2 cm approx.
Stripes
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