GEM FLOW COUPLER Instrucciones De Uso página 10

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 FLOW COUPLER
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.
3.5MM COUPLER SIZE OR LARGER:
END-TO-END ANASTOMOSIS:
1. to 8. Follow the same directions as for 3.0mm FLOW COUPLER Device Size or Smaller End-
to-End Anastomosis (Steps 1 through 8).
9. Take a bite of approximately one to two pin diameters of the vessel wall and intimal lining,
evert 90 degrees and impale onto the pin situated nearest to the open part of the Jaw
Assembly (open end of the U portion of the jaw). Impale the opposite side of the vessel
opening to the pin directly across from the initial pin. Next, impale the vessel onto the pins
located near the sides of the ring, keeping the vessel as evenly spaced as possible between the
four pins (See Figure 15). Continue vessel placement on the ring by impaling the vessel onto
the two remaining pins near the open end of the Jaw Assembly. Complete by impaling the
vessel onto the last two pins near the bottom of the Jaw Assembly (bottom of the U portion
of the jaw); this final step prevents the ring from sliding out of the Jaw Assembly prematurely
(See Figure 16). Ensure that both the vessel wall and the intimal lining 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 17.
10. Repeat Step 9 to impale the other vessel end upon the second FLOW COUPLER ring.
11 to 15. Follow the same directions as for 3.0mm FLOW COUPLER Device Size or Smaller
End-to-End Anastomosis (Steps 11 through 15).
FLOW DETECTION:
Prior to closure of the surgical site verify detection of blood flow.
1. Temporarily secure the probe wire to the skin to prevent the weight of the metal connectors
from pulling on the probe.
2. Join the probe connector to either end of the external lead. Attach the other end of the
external lead to the FLOW COUPLER Monitor.
3. Turn on the FLOW COUPLER Monitor.
NOTE: The FLOW COUPLER Monitor (GEM1020M-2) can be powered by a rechargeable
internal Lithium ion battery pack or with the external power supply. If the battery level is low or
critically low, use power supply.
The FLOW COUPLER Monitor (GEM1020M) can be powered by batteries (8 AA) or with the
external power supply. If the low battery light illuminates, either replace all 8 batteries or use
power supply.
NOTE: For further instructions, refer to the GEM FLOW COUPLER Monitor Instructions for Use.
4. Select appropriate channel on FLOW COUPLER Monitor and listen for blood flow. Adjust
volume as needed. If a strong audible signal is not identified, irrigate the site where the probe
tip meets the vessel with saline. During irrigation, an audible signal from the monitor verifies
proper function of the device.
NOTE: Do not attempt to adjust probe location.
5. When routing wire away from the anastomotic site, a loose suture may be placed around the
wire to ensure that it does not affect the orientation of the joined FLOW COUPLER rings.
Optimal wire position would be aligned with probe tip (See Figure 18). Do not bend probe
wire at a sharp angle. (see Figure 19) See Figure 20 for an example of proper probe wire
angle. Carefully position the probe wire to leave enough wire length in the wound, providing
slack to assure there is no tension on the anastomosis.
6. Once satisfied with wire placement, use a tack suture on the probe wire at the wound margin
(5-0 or similar). Secure the suture sleeve to the skin (suture, tape or staple). Ensure adequate
slack in the wire.
7. Following verification of probe function and wire placement, close the incision using
standard techniques. Cover exposed probe wire with medical dressing.
8. On an as needed basis, blood flow can be detected for up to 7 days. The probe is not
intended to be a permanent implant and should be removed 3 to 14 days post-operatively.
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