B. Empty the Reservoir
Refer to Figure 5 and follow Steps 1 through 7 to remove the purified water used in
manufacturing from the pump reservoir.
Required materials:
Components from the O.R. prep kit:
filling needle (clear hub)
stopcock
connecting tube
50 mL collection syringe
1.
Attach the filling needle, connecting tube, stopcock, and collection syringe
together (see Figure 5). Make sure the stopcock is closed.
2.
Remove the protective cover from the filling needle. Holding the needle
perpendicular to the pump, puncture the central port. Insert the needle
until it contacts the needle stop.
3.
Open the stopcock. The water in the reservoir will reflux into the syringe.
4.
When the reflux has stopped, wait 30 seconds to ensure that the reservoir
is empty. Close the stopcock.
5.
Turn the collection syringe upside down and remove it from the stopcock.
(This will help prevent dripping.)
6.
Remove the needle from the central port. Place the components on a sterile
surface to maintain sterility.
7.
Proceed to C. Flush the Residual Volume ("Dead Space") of the Reservoir.
WARNING: Do not implant the pump if liquid does not reflux from the drug
reservoir. Contact your local Codman Representative to secure a replacement.
14
C. Flush the Residual Volume ("Dead Space") of the Reservoir
Note: Because approximately 2 mL of purified water remains in the reservoir, the
drug solution will be diluted to a concentration of 90% in the 20 mL pump and 95%
in the 40 mL pump. If this is a concern, flush the reservoir with a small amount of
drug solution to decrease this effect (see Table 4 at the end of this section).
Required materials:
Additional 10 mL syringe with luer-lock connection
Prescribed drug solution (see Table 4 for quantity)
Components from the O.R. prep kit:
filling needle (clear hub)
stopcock
connecting tube
filter
To flush the reservoir, refer to Figure 6 and follow Steps 1 through 9:
1.
Transfer the desired amount of drug solution to a 10 mL syringe. Expel the air
from the syringe and remove the needle.
2.
Connect the syringe to the filter. Connect the filter to the stopcock and the
other components used to empty the reservoir.
3.
Open the stopcock. Expel air and approximately 2 mL liquid from the needle
to remove any liquid that remained in the components used to empty the
reservoir. Close the stopcock.
4.
Visually verify that there is no air bubble remaining in the filling assembly.
5.
Holding the needle perpendicular to the pump, puncture the central port.
Insert the needle until it contacts the needle stop.
6.
Maintaining slight thumb pressure on the syringe plunger, open the
stopcock. Inject the solution into the reservoir.
7.
Remove pressure from the syringe plunger and allow the solution to reflux into
the syringe. Wait 30 seconds after the reflux has stopped.
8.
Discard the 10 mL syringe and the refluxed drug solution appropriately.
9.
Proceed to D. Set Up the O.R. Prep Kit for Filling.