Le Maitre Vascular Over-the-Wire Mode D'emploi page 3

• Thrombus formation
• Wound infections
• Erythema
• Myocardial infarction
• Amputation
• Death
Additional Required Items
1. .035" Guidewire
2. Radiopaque Tape
Specifications
Over-the-Wire Valvulotome:
Blue Handle
Irrigation Port
LeMills Valvulotome:
Handle
Catalog Useable
Number Length
1005-00, 100 cm
e1005-00
1006-00, 40 cm
e1006-00
To Open Package
1. Open box and remove sealed sterile unit.
2. Open sealed sterile unit and present contents to personnel in sterile environment.
3. Carefully remove lids, as applicable.
Caution: Remove product from tray with care to ensure centering hoops are not damaged.
4. Place in basin filled with sterile, heparinized saline.
Pre-Use Check
Inspect centering hoops and cutting blades for damage and alignment prior to use.
Instructions for Use
1. Perform an intra-operative venogram using Radiopaque Tape; mark the fistulae.
2. Excise the Sapheno-Femoral Complex.
3. Excise first valve set under direct vision using standard technique.
4. Perform the proximal anastomosis.
5. Ensure that the leg is fully extended and pass the 0.035" guidewire well beyond the treatment area.
6. Flush the Over-the-Wire Valvulotome (in the open position) by removing Irrigation Port cap, blocking
guidewire lumen on the Blue Handle, and flushing with sterile heparinized saline. Replace cap upon
completion.
3
T-Handle
Body
Closed
Catheter Outer
Diameter
2.0 mm
2.0 mm
Green Safety
Stripe
Blade
Maximum Open Maximum Open
Cutting Blade Centering Hoop
Diameter
6.0 mm
6.0 mm
Centering
Hoops
Bullet Head
Protective
Cutting
Sheath
Blades
LeMills
Valvulotome
Diameter
9.5 mm Included
9.5 mm Not Included
0.035"