Synovis GEM FlowCOUPLER Mode D'emploi page 9

• Documentation of the technique and results of any magnetic testing performed on the implant
or that no such testing was done.
• Patient education regarding the particular implant and recommendation for identifying medical
alert card, bracelet, or necklace characterizing the implanted device.²
3.0MM COUPLER SIZE OR SMALLER:
END-TO-END ANASTOMOSIS:
Using conventional microsurgical technique, mobilize a minimum of 1 cm of each vessel
end. Using vascular clamps, clamp off the vessel(s) and irrigate the vessel openings. The
FlowCOUPLER requires a greater amount of free vessel within the clamps than a conventional
suture repair.
1. After gentle dilation, estimate the outer diameter of each vessel using the Vessel Measuring
Gauge. The circular guides on the gauge should not be placed inside the vessel lumen (See
Figure 1). If there is a size discrepancy between the two vessels, use the measurement of the
smaller vessel to choose the appropriate FlowCOUPLER. The degree of vessel spasm and the
elasticity of the vessel should be considered when choosing the FlowCOUPLER size to be
used.
2. Select the appropriate size FlowCOUPLER. Both vessel ends should be approximately the
same size as the inside diameter of the FlowCOUPLER being selected.
3. Remove the lid from the outer tray and aseptically remove the inner tray; the inner tray may
be placed in the sterile field. Inspect the inner tray. Do not use if the inner tray is damaged or
if the seals are not intact. Remove the lid from the inner tray.
4. Turn the Anastomotic Instrument knob fully counterclockwise, and then insert the
FlowCOUPLER onto the Anastomotic Instrument while FlowCOUPLER is still in tray. The
matching indicator arrows on the FlowCOUPLER and the Anastomotic Instrument
should be pointing toward each other when loading (See Figures 2 & 3). Ensure that an
audible click is heard for proper loading.
5. Remove FlowCOUPLER from tray and protective cover, being careful not to pull the wire
(See Figure 4).
6. Verify probe function by connecting probe to Monitor and irrigating attached probe tip with
sterile saline. (Refer to the Flow Detection section of these Instructions for Use for proper
connection instructions.) An audible signal from the Monitor verifies proper function of the
device. If no signal is identified, refer to the Troubleshooting section of these Instructions for
Use.
7. Visually inspect to see that both rings are seated at the bottom of the U portion of the jaw
(See Figures 5a & 5b) and the pins are not bent. If pins are bent, do not attempt to straighten.
Instead use a new FlowCOUPLER Device.
NOTE: To avoid unwanted kinking or twisting of the vessel during positioning of the flap, care
should be taken to establish the desired angle of the probe wire relative to the flap and to adjust
the Anastomotic Instrument accordingly prior to starting the anastomosis.
8. Place the Anastomotic Instrument perpendicular to the vessel(s), with the FlowCOUPLER
jaw assembly near the two vessel ends. Pull one vessel end through one of the
FlowCOUPLER rings using microsurgical forceps (See Figure 6). Care should be taken
to avoid twisting of the vessel.
9. Take a bite of approximately one to two pin diameters of the vessel wall and intimal lining,
evert 90 degrees and impale onto one pin. Proceeding in a triangular fashion, impale the
vessel firmly upon every other pin, completing three pins (See Figure 7). Complete vessel
placement on the ring by impaling the vessel upon the remaining three intermediate pins (See
Figure 8). Ensure that both the vessel wall and the intimal layer are fully impaled upon each
pin to reduce the risk of thrombosis. Should the vessel wall tear during impalement, remove
the vessel, trim the end, and repeat the procedure. For examples of improper impalement of
the vessel (See Figure 9).
10. Repeat Steps 8 and 9 to impale the other vessel end upon the second FlowCOUPLER ring.
11. When both vessel ends have been suitably impaled, visually inspect to ensure that both
rings are seated at the bottom of the U portion of the jaw (See Figures 5a & 5b) and the pins
are not bent. Bring the rings together (See Figures 10 & 11) by turning the Anastomotic
Instrument knob clockwise.
12. Prior to ejecting the joined rings, gently squeeze the end of the apposed jaws with a
small hemostat (See Figure 12) to ensure ring approximation and a tight friction fit. Turn
the Anastomotic Instrument knob further clockwise to eject the joined rings.
13. Check the anastomosis under the operating microscope before opening the vascular clamps.
Remove the clamps and inspect the anastomotic site to ensure that the anastomosis has
been satisfactorily completed (patent vessel without leakage).
14. To remove the jaw assembly turn the Anastomotic Instrument knob fully counterclockwise
(See Figure 13). Press the release button, located near the arrow on the Anastomotic
Instrument, and remove the jaw assembly (See Figure 14).
15. Rinse the Anastomotic Instrument with water after use.
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