Instructions for Use – Refilling the Implanted Pump
D. Refilling the Drug Reservoir (refer to Figures 4a and 4b)
CAUTION: Before refilling the reservoir, ensure that the remaining drug solution has
been removed (see Emptying the Drug Reservoir).
CAUTION: Before changing the concentration of the drug solution, first empty the
reservoir, then rinse the reservoir twice with sterile 0.9% saline solution as instructed
in Rinsing the Drug Reservoir.
CAUTION: The contents of the pump are under pressure. In performing Steps 3b
and 3c, do not completely remove your thumb from the plunger of the 10-mL syringe.
Use your thumb to keep the plunger under control. Failure to control the plunger may
cause drug solution to spill.
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.
1.
Ensure that the stopcock handle is turned so it points to the filling needle. Reattach
the 10-mL syringe containing 5 mL of drug solution to the straight female fitting of
the stopcock.
2.
Check the drive function of the pump.
a.
Depress the plunger of the 60-mL syringe until the 10-mL syringe fills with
drug solution.
b.
While keeping your thumb on the plunger of the 10-mL syringe ready to
counteract the reflux pressure of the pump, turn the stopcock handle so it
points to the perpendicular fitting. Inject the contents of the 10-mL syringe
into the reservoir.
c.
Check the function of the pump's drive system by releasing the pressure from
the plunger of the 10-mL syringe for a few seconds. Reflux must appear in
the syringe.
d.
Inject the remaining contents of the 10-mL syringe into the reservoir.
e.
While continuing to exert pressure on the 10-mL syringe plunger, turn
the stopcock handle so it points to the filling needle.
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3.
Inject the remaining drug solution.
a.
Depress the plunger of the 60-mL syringe until the 10-mL syringe fills with drug
solution.
b.
While keeping your thumb on the plunger of the 10-mL syringe ready to
counteract the reflux pressure of the pump, turn the stopcock handle so it
points to the perpendicular fitting. Inject the contents of the 10-mL syringe
into the reservoir.
c.
While continuing to exert pressure on the 10-mL syringe plunger, turn the
stopcock handle so it points to the filling needle.
d.
Repeat Steps 3a through 3c until the correct volume of the drug solution
has been injected.
4.
Remove the filling needle from the central port and, if necessary, cover the injection
site with a self-adhesive sterile bandage.
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9/27/2011 12:26:23 PM