Figure 41. Slide the collets towards the connector
until the teeth touch
8. Place the tubing connection in the Quick Connect Assembly tool jaw and squeeze
the tool handles until the closure stop touches the opposite handle. Do not hold the
tubing connection while squeezing the tool jaw as this could cause misalignment.
Check that all the collet teeth are entering the connector before completing the
connection.
• If using a Straight Connector, use the tool once (Figure 42).
• If using a Right-Angle Connector, use tool twice, once on each end of the
connector (Figure 43).
• If using a Y Connector, the assembly tool must be used 3 times - once on each
end of the connector (Figure 44).
Figure 42. Place the connection in the tool jaw with
the tubing exiting straight from the connector ends
Figure 43. Use the tool twice when using a right
angle connector – once on each connector end
Figure 44. Quick Connect Assembly Tool (approach
from the side of the Y Connector)
CAUTION:
• Check the tubing before closing the assembly tool. Do not trap tubing between
the assembly tool jaw and the connector. The tubing must exit straight from the
ends of the connector, through the slots in the assembly tool.
• After using assembly tool, tubing should bulge through connector window. This
indicates that tubing is firmly against middle of connector wall.
9. After all connections have been made, cycle the device to confirm function and
urethral coaptation, and deactivate the device (see Deactivate Cuff section).
Suture-Tie Connectors
All connections using Suture-Tie Connectors are tied with 3-0 non-absorbable
polypropylene.
1. Cut the tubing length to fit the patient's anatomy with clean, straight scissors,
making sure the cut end is square (Figure 37).
2. Use a 22 gauge needle attached to a 10 ml syringe filled with filling solution to flush
connector and tubing to remove particulate matter and air.
3. Push the tubing over the ends of the connector so that they meet at the center hub
of the connector.
Note: Make sure the tubing is on the connector straight.
4. Use a double-throw overhand surgeon's knot followed by a minimum of two single
throws to attach the tubing to the connector (Figure 45).
Figure 45. Tie suture
Note: The suture should crimp, but not cut the tubing.
5. Pass the suture 180 degrees and use the same tying technique on the opposite
side of the connector. Use another suture and repeat on the opposite end of
the connector.
6. After all connections have been made, cycle the device to confirm function and
urethral coaptation, and deactivate the device (see Deactivate Cuff section).
Deactivate Cuff
The device system must be left in the deactivated mode for four to six weeks following
implantation.
1. Squeeze and release the pump bulb several times to remove all fluid from cuff
(Figure 46).
Figure 46. Squeeze and release pump bulb
Note: The cuff will be empty when the pump remains flat.
2. Allow pump bulb to partially refill (approximately 30 to 60 seconds).
Note: It is recommended to record the time needed to refill the pump and the
number of pump squeezes needed to empty the cuff and pump as this information is
helpful postoperatively.
3. When slight indentation in pump bulb is felt, press the deactivation button
(Figure 47). After the deactivation button is pressed, the pump bulb may feel firmer
than usual.
Figure 47. Press deactivation button when slight
indentation is felt
15
Black (K) ∆E ≤5.0