Important User Information - GE Xcellerex XDM Series Operating Instructions Manual

1.2

Important user information

Read this before operating the
product
All users must read the entire Operating Instructions before installing, operating or
maintaining the product.
Always keep the Operating Instructions at hand when operating the product.
Do not operate the product in any other way than described in the user documentation.
If you do, you may be exposed to hazards that can lead to personal injury and you may
cause damage to the equipment.
Intended use of the product
Xcellerex XDM and Xcellerex XDUO mixers are plug-and-play single-use mixing systems
used in commercial production of biopharmaceuticals, vaccines, and other biologics.
The XDM mixer is designed to operate as a stand-alone instrument. XDUO mixers can
be operated as a stand-alone instrument or as a FlexFactory™ component.
XDM and XDUO mixers are not medical devices and must not be used in any clinical
procedures, or for diagnostic purposes.
XDM and XDUO mixers are not intended for use in a potentially explosive atmosphere.
Prerequisites
In order to operate XDM and XDUO mixers in the way it is intended:
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Xcellerex XDM 50-1000, XDUO 100-1000 mixers Operating Instructions 29251615 AD
The user must have a general understanding of the use of general biomanufacturing
equipment and local practices for biosafety and the handling of biological materials.
The user must read and understand the Safety instructions chapter in this manual.
Supervisors and administrators must be familiar with basic operations in Microsoft
®
Windows operating system.
The product must be installed in accordance with the site requirements and instruc-
tions in the Operating Instructions.
1 Introduction
1.2 Important user information
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