A. Setting Up and Priming the Refill Assembly
(see Figures 2a, 2b and 2c)
1.
Check the patient's records for the drug reservoir capacity and verify that the amount
of drug solution does not exceed the drug reservoir capacity plus the approximately
3 mL lost in priming.
2.
Use the aspiration needle to fill the 60-mL syringe with the drug solution. Expel the
air from the syringe. Remove the aspiration needle.
3.
Assemble the parts (see Figure 2a).
a.
Connect the filter to the 60-mL syringe.
b.
Connect one of the connecting tubes to the filter.
c.
Connect the free end of this connecting tube to the perpendicular fitting
of the stopcock.
d.
Connect the SURECAN Filling Needle to the second connecting tube.
e.
Connect the second connecting tube to the stopcock male fitting.
f.
Turn the stopcock handle so it points to the filling needle.
g.
Slowly depress the plunger of the 60-mL syringe until drug solution appears
at the open female fitting of the stopcock.
h.
Ensure that the plunger of the 10-mL syringe is fully depressed. Connect the
10-mL syringe to the stopcock.
i.
Fill the 10-mL syringe with 5 mL of solution by slowly depressing the plunger
of the 60-mL syringe (see Figure 2b).
j.
Turn the stopcock handle so it points to the perpendicular fitting. If air is
present in the 10-mL syringe, remove the syringe and expel the air; reconnect
the syringe to the stopcock.
k.
Remove the protective cover from the filling needle.
l.
Slowly depress the plunger of the 10-mL syringe until drug solution exits
from the filling needle (Figure 2c). The assembly is now primed. Replace
the protective cover on the filling needle.
Note: Once the system is primed, monitor the dosage amount through the use of
the 10-mL syringe. Deliver only the amount that corresponds to the drug reservoir
capacity. If less than 3 mL was used to prime the system, discard the excess in the
appropriate manner.
4.
Turn the stopcock handle so it points to the filling needle. Remove the 10-mL syringe.
Place the 10-mL syringe and the remainder of the assembly on a sterile field.
CODFR11091zz01svn.indd 13
CODFR11091zz01svn.indd 13
Instructions for Use – Refilling the Implanted Pump
Filling needle
2a
Connecting tubes
Stopcock
Drop of drug solution
2b
2c
Filter
60 mL syringe
10 mL syringe
Drug solution
Instructions for Use – 13
9/27/2011 12:26:23 PM
9/27/2011 12:26:23 PM