GEM COUPLER Instructions D'utilisation page 10

2. Select the appropriate size COUPLER Device. Both vessel ends
should be approximately the same size as the inside diameter of
the COUPLER Device 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 COUPLER onto the Anastomotic
Instrument. The matching indicator arrows on the COUPLER
Device 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 COUPLER Device from the protective cover by
pulling it firmly away from the Anastomotic Instrument (See
Figure 4).
6. Visually inspect to see that both rings are seated at the bottom
of the U portion of the jaw and the pins are not bent (See
Figures 5a & 5b). If pins are bent, do not attempt to straighten.
Instead use a new COUPLER Device.
7. Place the Anastomotic Instrument perpendicular to the
vessel(s), with the COUPLER jaw assembly near the two vessel
ends. Pull one vessel end through one of the COUPLER rings
using microsurgical forceps (See Figure 6).
8. 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.
9. Repeat Steps 7 and 8 to impale the other vessel end upon the
second COUPLER ring.
10. 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 and the pins are not bent (See Figures 5a
and 5b). Bring the rings together (See Figures 10 & 11) by
turning the Anastomotic Instrument knob clockwise. Turn
the knob only until the ejector rod has just started to move the
now joined rings.
11. 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.
12. 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).
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