Synovis Flo-Rester Mode D'emploi page 3

II. USAGE
The Flo-Rester size is chosen based upon the internal diameter of the
vessel. The flexible shaft is held by pickups adjacent to the bulb to be
inserted. The Flo-Rester is designed to easily slide inside the vessel. Never
force the Flo-Rester into the vessel as subintimal dissection could occur.
The first bulb is inserted through the vessel opening and into one side of
the vessel. The second bulb is inserted in a similar manner. When correctly
placed the Flo-Rester flexible shaft will be straight. The pull tab is laid to
one side out of the way (see illustration). Unless there are perforating vessels
between the bulbs of the Flo-Rester,
bleeding from the vessel is completely
controlled.
The Flo-Rester allows the blood vessels
to be easily visualized since the walls of
the vessels are separated by the bulbs.
III. CLEANING
After use, the Flo-Rester should be carefully washed with enzymatic
detergent according to detergent manufacturer's instructions. All residue
should be removed. A final rinse in non-pyrogenic water is recommended.
If blood is seen in the tubing, it indicates that the tubing has been
punctured by a needle or similar object. When this occurs, the Flo-Rester
should be replaced as it is impossible to remove the blood from the tubing.
IV. STERILIZATION
The Flo-Rester must be removed from the pouch and then should be
wrapped in a clean, lint-free surgical towel or other suitable lint-free
wrapping. It is recommended that the device be sterilized NO MORE
THAN FIVE (5) TIMES by one of the following methods:
• Ethylene Oxide (EtO) gas sterilization according to standard validated
hospital procedures
• Steam sterilization at 134°C for 3.5 minutes (270°F, U.S.)
• Steam sterilization at 121°C for 15 minutes (250°F, U.S.)
WARNINGS
• Flo-Resters must be sterilized before use (see STERILIZATION).
• Due to the possible danger of tearing because of the friability of some
vessels, care must be used in dealing with these vessels.
• Sub-intimal dissection must be guarded against. NEVER force the Flo-
Rester bulb into a vessel.
• Carefully choose the correct Flo-Rester size according to bulb diameter
required.
• During anastomosis of the graft to the artery, care must be exercised so
the suture needle will not pierce the Flo-Rester's bulb or shaft. The
silicone rubber is soft and similar to tissue in consistency. Thus, it is not
easy to feel the needle entering the bulb or shaft.
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