Function - Sartorius Biowelder Total Containment Mode D'emploi

Introduction
10 Operating Manual Biowelder
The Biowelder TC was designed for industrial use and may not be used for
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medical applications. Please refer to Chapter 1 Hazard Information for
additional limitations. The connection created by the Biowelder
meet the requirements for medical applications. It is the responsibility of the
user to decide whether the device is suitable. Examine welds thoroughly
before using them.
4.4

Function

The Biowelder TC is used for the sterile welding of two tube pieces. Every
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piece of tube is connected on one end to a container, bag or process unit.
The other end is sealed with a clamp, plug or another seal. To create a sterile
connection, first place the two tubes in the tube holder of the
Biowelder TC. Then a new blade is inserted into the blade holders of the
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device. Closing the cover and pressing the start button activates the steps
in the welding programme. In the first step the blade is heated to over
400°C and held for 5 seconds at this temperature. This step guarantees that
the blade is sterile and pyrogen-free. Then the blade is cooled to the
required cutting and welding temperature which depends on the type of
tube. Afterwards the heated blade simultaneously cuts through the two
pieces of tube. The blade temperature is controlled during the cutting
process. Once the tubes have been cut through, the device turns the tubes
so that they line up. The blade is then pulled back, the tubes pressed
together and the weld cooled off. The release of the cover signals the end of
the welding and the device can be opened. The welded tube is taken out
and is now ready for use. The used blade and the waste tube are removed.
The Biowelder TC is a fully automatic unit and displays the successful
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conclusion of the welding if all steps were followed properly. The process is
completely reproducible.
The device is programmed with standard parameter sets for welding C-Flex
374, AdvantaFlex , PharMed
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These parameter sets have been validated at room temperature.
The use of a new blade after each welding prevents cross-contamination
and to ensure proper welding quality. To simplify the logging of welding data
for the user, the Biowelder
written as needed. In addition, data can be loaded to a computer through a
Web browser. To simplify the validation or to facilitate the validation process
for the customer, a validation set matching the device can be acquired for
the Biowelder TC as an option.
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Total Containment
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BPT and SaniPure BDF
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TC has a memory card to which data can be
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TC cannot
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.
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