LeMaitre 1601-24 Instrucciones De Uso página 2

LeMaitre® Embolectomy Catheter
(Model Numbers 1601-24, e1601-24, 1601-26, e1601-26, 1601-28, e1601-28,
1601-34, e1601-34, 1601-38, e1601-38, 1601-44, e1601-44, 1601-48, e1601-
48, 1601-54, e1601-54, 1601-58, e1601-58, 1601-68, e1601-68, 1601-78,
and e1601-78)
Instructions for Use - English
Size
2 F
3 F
4 F
5 F
6 F
7 F
8F*
*Not available in the U.S.
Indications for Use
The LeMaitre Embolectomy Catheter is indicated for the removal of arterial
emboli and thrombi.
Contraindications
The LeMaitre Embolectomy Catheter should not be used for endarterectomy,
dilating vessels or venous thrombectomy.
Directions For Use
1. Remove the stylet and inflate the balloon with a physiologically
compatible sterile fluid. A compatible syringe with a delivery volume
as close as possible to the capacity of the balloon should be selected.
Pull a vacuum on the syringe to remove air from the catheter. Repeat
the inflation, if necessary, and reapply negative pressure until all air is
removed. NOTE: Inspection for leaks should be performed during this step.
Do not use if leakage is observed.
2. Insert the catheter, with the balloon deflated, into the vessel and beyond
the material to be extracted. A removable stainless steel stylet is provided
to assist in the introduction of the catheter into the vessel, if necessary.
3. With the catheter in the proper position, inflate the balloon with sterile
fluid. Stop once the balloon has engaged the vessel wall.
4. Withdraw the catheter and remove the obstructing material. During
withdrawal it is important to adjust the balloon diameter by controlling
the inflation volume so it conforms to the varying diameter of the vessel.
Warning
• This product contains Natural Rubber Latex which may cause allergic
reactions.
• To avoid air embolus in case of balloon rupture, air should not be used for
balloon inflation.
• Exposure to calcified plaque may increase the risk of balloon rupture.
• The use of a highly viscous or particulate contrast medium may occlude
the inflation/deflation lumen.
• The maximum inflation volume must not be exceeded because of the risk
of the balloon bursting. Refer to the table. Balloon rupture is sensed by a
LATEX
Maximum Liquid
Volume (ml)
0.05
0.20
0.75
1.50
1.60
1.75
3.00
Inflated Balloon
Diameter (mm)
4.5
8.0
10.5
13.0
13.5
14.0
17.5