LeMaitre NovaSil Instrucciones De Uso página 2

NovaSil™ Silicone Single Lumen Embolectomy Catheter
(Model Numbers 1801-26, e1801-26, 1801-34, e1801-34, 1801-38, e1801-38,
1801-44, e1801-44, 1801-48, e1801-48, 1801-54, e1801-54, 1801-58, e1801-
58, 1801-68, e1801-68, 1801-78, and e1801-78)
Instructions for Use - English
Size
2 F
3 F
4 F
5 F
6 F
7 F
Indications for Use
The NovaSil™ Silicone Single Lumen Embolectomy Catheter is indicated for
the removal of arterial emboli and thrombi.
Contraindications
The NovaSil™ Silicone Single Lumen Embolectomy Catheter should not be
used for endarterectomy, dilating vessels or venous thrombectomy.
Instructions 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 us 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 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. Withdrawal 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
• To avoid air embolus in case of balloon rupture air should not be used for
balloon inflation.
• Exposure to calcified plaques 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 balloon bursting. Refer to the Table above. Balloon rupture is sensed
by a decrease in resistance of the syringe plunger during inflation. If a
balloon ruptures, discontinue inflation and remove the catheter at once
• Do not use if product or sterile packaging is damaged.
Maximum Liquid
Volume (ml)
0.05
0.20
0.60
1.00
1.60
1.75
Inflated Balloon
Diameter (mm)
4
6
9
11
13
14