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En Instructions For Use; Product Description; General Information And Warnings - PFM Medical ASEPT Gebrauchsanweisung

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Instructions for Use
ASEPT® Replacement Valve (Order# P09080005)

Product description

The ASEPT® Replacement Valve is intended for replacing the valve attached to the ASEPT® Pleural or Peritoneal
Drainage Catheter in case of occlusion or malfunction. This is a guide to replace the ASEPT® Valve. Please refer
to the ASEPT® Pleural Drainage System or the ASEPT® Peritoneal Drainage System Instructions for Use for more
information on the operation of either system.

General Information and Warnings

W A R N I N G S
Do not reuse. Intended for single patient use. The reuse of this single-use device can affect
safety, performance and effectiveness, exposing patients and staff to unnecessary risk.
Do not use if package is opened or damaged
Application
Before beginning to replace the valve please have the following items:
• Scissors
• Forceps with rubber shods
• Alcohol Pads
Clamp the ASEPT® catheter to prevent air from entering the catheter. Use rubber shods in-between the forceps
to prevent damage to the catheter and cut the ASEPT® catheter between the forceps and the connector.
Using proper aseptic technique wipe the surface of the replacement connector that will be inserted into the
catheter with an alcohol pad.
Insert the catheter tubing all the way into the valve connector. Remove the forceps.
Sterility
The ASEPT® Replacement Valve is provided sterile and non pyrogenic. Provided that the package is not compro-
mised in any way, the package will serve as an effective barrier until the "Use By" (expiration) date printed on the
box. This device is for single use. Do not re-sterilize.
Warranty
pfm medical warrants that this medical device is free from defects in both materials and workmanship. The
above warranties are in lieu of all other warranties, either expressed or implied, including any warranty of
merchantability or fitness for a particular purpose. Suitability for use of the medical device for any surgical
procedure shall be determined by the user. pfm medical shall not be liable for incidental or consequential
damages of any kind.
22.05.2015_Rev. L1472/C
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