LeMaitre Syntel A4F00 Gebrauchsanweisung Seite 2

Syntel® Silicone Embolectomy Catheter - Spring Tip
(Model Numbers A4F00, A4F01, A4F02, A4F03, A4F04, A4F05, A4F06, A4F07, A4F08)
Instructions for Use - English
Product Description
Syntel Embolectomy Catheters consist of a catheter body with a silicone balloon on the distal end and an infl ation hub on the proximal end.
Indications for Use
Syntel Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system.
Contraindications
Syntel Embolectomy Catheters are contraindicated for endarterectomy procedures or for use in the venous system, grafts, shunts, or as a vessel dilator.
Instructions for Use
1. The catheter balloon should be infl ated with a sterile, nonparticulate, blood compatible liquid or CO2.
2. If using CO2, corrections to infl ation volume may be necessary due to CO2 diff usion through the balloon wall.
3. Purge the catheter of all air with a sterile medium.
NOTE: Inspection for leaks should be performed during this step. Do not use if leakage is observed.
4. For optimal control, use the smallest syringe capable of holding infl ation medium.
5. Insert the catheter through the arteriotomy and position the balloon just past the occlusion.
6. Infl ate the balloon with a sterile medium. Infl ation should continue until the balloon can be felt to have engaged the vessel wall.
7. Withdraw the catheter and thrombus through the arteriotomy.
Warnings
• Air should not be used to infl ate the balloon.
• Do not exceed maximum pull force specifi cations as balloon rupture and catheter separation may result (See Specifi cation Table).
• Do not use if product or sterile packaging is damaged.
Potential Complications
Complications associated with the use of embolectomy catheters include, but are not limited to: systemic infection, local hematomas, intimal disruptions, arterial dissection, perforation
and rupture, hemorrhage, arterial thrombosis, distal emboli of blood clots or arteriosclerotic plaque, air embolus, aneurysms, arterial spasms, arteriovenous fi stula formations, and balloon
rupture or tip separation with fragmentation and distal embolization.
Precautions
• Balloon degradation and rupture may result from exposure to adverse environmental conditions, excessive handling, or deposits within the vessel.
• Maximum recommended infl ation volumes should not be exceeded (See Specifi cation Table).
• Balloon rupture is sensed by a decrease in resistance of the syringe plunger during infl ation. If a balloon ruptures, discontinue infl ation and remove the catheter at once.
• To minimize inner wall pressure and shear forces to the inner surface of the artery, use of the smallest infl ated balloon diameter to remove the obstructing material is recommended.
Storage
Handle with care. Product should be stored in a clean, cool, dry area away from chemical fumes.
How Supplied
This device is supplied sterile and non-pyrogenic.
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 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.
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
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, fi berboard box. The outer shipping container must be provided with suffi cient
cushioning material to prevent movement between the secondary and outer containers.
Max. Liquid CO2 Volume
Size
Volume (ml) (ml)
2F 0.08 0.3
3F 0.20 0.6
4F 0.75 1.7
5F 1.50 3.0
6F 2.00 4.5
7F 2.50 5.0
following:
2
Infl ated Balloon Max Pull Force on Infl ated
Diameter (mm) Balloons (lbs.)
4 0.5
6 0.7
9 1.5
11 2.0
13 2.5
14 3.5