GEM FlowCOUPLER Instrucciones De Uso página 10

3.5MM COUPLER SIZE OR LARGER:
END-TO-END ANASTOMOSIS:
1. to 8. Follow the same directions as for 3.0mm FlowCOUPLER 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 FlowCOUPLER ring.
11 to 15. Follow the same directions as for 3.0mm FlowCOUPLER 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 FlowCOUPLER Monitor.
3. Turn on the FlowCOUPLER Monitor.
NOTE: The FlowCOUPLER Monitor 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 FlowCOUPLER Monitor Instructions for Use.
4. Select appropriate channel on FlowCOUPLER 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 FlowCOUPLER 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.
9. When monitor is not being used to detect flow, external lead may be disconnected from the
probe by pulling probe connectors apart.
NOTE: Ischemia or reperfusion rate may delay or affect the initial Doppler signal.
NOTE: If blood flow is not detected with the Monitor post-operatively, rely on clinical
indications for patient status.
NOTE: Doppler signal may vary during monitoring period.
10. To remove the probe, first detach the suture sleeve and wire from the skin (remove suture,
tape or staple). Remove the probe by applying gentle traction to the wire while applying
counter pressure externally at the site of incision until the probe is extracted. Inspect to ensure
that probe tip is fully intact. If probe is not present, surgical removal is required.
Devices: Anastomotic Instrument, Vessel Measuring Gauge, COUPLER Forceps, and
Sterilization Tray.
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