LeMaitre Syntel 1801-26 Mode D'emploi page 2

Syntel® Silicone Embolectomy Catheter - Regular Tip
(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
Indications for Use
The Syntel® Silicone Embolectomy Catheter - Regular Tip is indicated for the removal of arterial emboli and thrombi.
Contraindications
The Syntel® Silicone Embolectomy Catheter - Regular Tip 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 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 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
• 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.
Complications
In common with other catheterization procedures, complications may occur. These may include intimal disruption, vessel wall perforation, balloon rupture with fragmentation, tip separa-
tion, local or systemic infection, arterial thrombosis, local hematomas, air embolus, plaque, arterial dissection, and hemorrhage.
Storage
Store the catheters in a dry, dark area away from heat and chemicals.
Resterilization/Re-use
This device is single-use only. Do not reuse, reprocess, or re-sterilize. The cleanliness and sterility of the re-processed device cannot be assured. Reuse 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.
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.
If serious medical incidents should arise during use of this medical device, users should notify both LeMaitre Vascular and the Competent Authority of the country where the user is located.
This product contains no sharps, heavy metals or radioisotopes, and is not infectious or pathogenic. No special requirements for disposal are evident. Please consult local regulations to
verify proper disposal.
Cleaning
1. Devices considered necessary to return should be cleaned using one of the following:
a) Sodium hypochlorite solution (500-600 mg/l), or
b) Peracetic acid solution with subsequent ultrasonic treatment
2. Devices should then be decontaminated with either:
a) 70% solutions of ethanol or isopropanol for a minimum of 3 hours or,
b) Ethylene oxide gas
3. Devices should be completely dried prior to packaging.
Packaging
1. Cleaned devices should be sealed and packed in a manner that minimizes potential for breakage, contamination of the environment or exposure to those handling such packages during
transit. For devices capable of penetrating or cutting skin or packaging material, the primary packaging must be capable of maintaining the product without puncture of the packaging
under normal conditions of transport.
2. The sealed primary container should be placed inside watertight secondary packaging. The secondary packaging should be labelled with an itemized list of the contents of the primary
receptacle. Cleaning methods should be detailed if possible.
3. Both primary and secondary packaging of cleaned, decontaminated single-use disposable devices should be labelled with an ISO 7000-0659 Biohazard symbol.
4. Primary and secondary packaging must then be packaged inside an outer package, which must be a rigid, fiberboard box. The outer shipping container must be provided with sufficient
cushioning material to prevent movement between the secondary and outer containers.
5. Shipping paper and content marking for the outer shipping container are not required.
6. Packages prepared in the above manner may be shipped to:
Maximum Liquid Inflated Balloon
Size
Volume (ml) Diameter (mm)
2 F 0.05
3 F 0.20
4 F 0.60
5 F 1.00
6 F 1.60
7 F 1.75
LeMaitre Vascular
Attn: Complaint Lab
63 Second Avenue
Burlington, MA 01803
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