Instructions For Use; Refilling The Implanted Pump - Codman AS 10 Manual Del Usuario

Instructions for Use – Refilling the Implanted Pump

INSTRUCTIONS FOR USE

These instructions do not address the procedure for initial filling of the drug reservoir
in preparation for implantation. Follow the instructions in Preparing the Pump in the
user manual that is packaged with the ARCHIMEDES Implantable Infusion Pump.

Refilling the Implanted Pump

PRECAUTIONS
Ensure that all luer-lock connections are secure.
Never overfill the drug reservoir. Always be sure to identify the reservoir capacity
before performing a refilling procedure.
Use only the SURECAN Filling Needle provided with the CODMAN Refill Kit
(AS 10), to access the central port. Use of other needles can damage the central
port and/or result in a failure to administer solution appropriately.
Always follow the instructions for removing the remaining drug solution before
refilling the drug reservoir. Failure to remove the remaining drug solution can
result in overfilling the reservoir. Overfilling can result in overinfusion, which
can lead to a drug overdose or cause damage to the pump.
Do not aspirate during emptying of the drug reservoir. Allow pump pressure to
evacuate the drug reservoir during the emptying procedure. Aspiration of the
reservoir can damage the pump's drive system.
The drug reservoir contents are under significant pressure. To prevent the
reservoir contents from being ejected, do not use an open syringe when emptying
the drug reservoir.
Always ensure proper needle placement (needle held perpendicular to the pump and
inserted completely to the needle stop) before refilling the reservoir.
Use of excessive force when inserting the filling needle into the central port can
damage the needle tip. Never use a filling needle if the tip is bent; use the second
filling needle provided. Using a bent filling needle will cause damage to the central
port, and can result in a failure to administer solution appropriately.
Instructions for Use – 12
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The procedure for refilling an implanted pump consists of five steps:
A. Setting up and priming the refill assembly;
B. Emptying the drug reservoir of the remaining drug;
C. Rinsing the drug reservoir (required to change the drug or drug concentration);
D. Refilling the drug reservoir; and
E. Completing the documentation.
Required materials:
• Aspiration needle
• CODMAN Refill Kit (AS 10)
• Appropriate amount of drug solution (volume to be determined by the
capacity of the drug reservoir)
• 3 mL of drug solution to prime the refill assembly
• Skin disinfectant
• Self-adhesive sterile bandage (optional)
Additional materials if rinsing the drug reservoir:
• Aspiration needle
• (2) 10-mL syringes with luer-lock connectors
• 10 mL of sterile 0.9% saline solution
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