How Supplied; Instructions For Use; Injecting A Bolus Into An Implanted Pump - Codman MedStream Gebrauchsanweisung

How Supplied

This product is for SINGLE USE ONLY; DO NOT RESTERILIZE. Codman Single Use
devices have not been designed to undergo or withstand any form of alteration, such as
disassembly, cleaning or resterilization, after a single patient use. Reuse can potentially
compromise device performance and any usage beyond the design intent of this single-
use device may result in unpredictable loss of functionality.
Codman & Shurtleff will not be responsible for any product that is resterilized, nor
accept for credit or exchange any product that has been opened but not used.
As long as the inner unit is not opened or damaged, the product is sterile.
The following components have been tested and were determined to be nonpyrogenic:
Needles
Connecting tube with stopcock
The following components have been tested and were determined to have
a nonpyrogenic fluid pathway:
Filter
Syringes

INSTRUCTIONS FOR USE

These instructions do not address the procedure for priming the bolus channel in
preparation for implantation. Follow the instructions for Priming the Bolus Channel
in the user manual provided with the MedStream Pump.
CODFR11052zz03svn.indb 5 CODFR11052zz03svn.indb 5
Injecting a Bolus into an Implanted Pump (Refer To Figure 3)
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Connecting tube
Central port (filling only)
Bolus needle
Skin surface
Bolus port
Implanted infusion pump
PRECAUTIONS
Ensure that all luer-lock connections are secure.
Always ensure proper needle placement (needle held perpendicular to the
pump and inserted completely to the needle stop) before injecting a bolus.
Use of excessive force when inserting the bolus needle into the bolus
port can damage the needle tip. Never use a bolus needle if the tip is
bent; use the second bolus needle provided. Using a bent bolus needle
can cause damage to the bolus port, and result in a failure to administer
solution appropriately.
Gently flush the bolus channel with sterile 0.9% saline solution after each
bolus injection.
Required materials:
• Aspiration needles
• MedStream Bolus Kit
• 5 mL of sterile 0.9% saline solution
• Drug solution
• Skin disinfectant
• Self-adhesive sterile bandage (optional)
Stopcock
Filter
10 mL syringe
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