CORNING 6928 User manual

Corning®
X-WASH®System
Instruction Manual
Catalog Numbers:
6928
6929
6930
6931
6932
6933

3
Instruction Manual
Table of Contents
Introduction .................................................... 4
Safety. .......................................................... 9
Corning® X-WASH® System......................................14
X-SERIES® DataTrak Software ...................................22
Corning X-WASH System Operating Instructions .................28
X-SERIES DataTrak Software: System Setup ......................51
X-SERIES DataTrak Administration Mode .........................53
X-SERIES DataTrak Operations Mode ............................59
Maintenance, Cleaning, and Disinfection ........................63
Troubleshooting................................................64
Technical Support ..............................................67
Specifications ..................................................67
Product Disposal ...............................................74
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4CORNING X-WASH SYSTEM
1.0 Introduction
The Corning® X-WASH® System is a semi-automated, functionally closed,
system that separates, washes, and volume-reduces cell samples to a
programmable volume. The X-WASH System is used with a commercially
available centrifuge and personal computer (not supplied).
The system consists of four major components:
• Corning X-WASH Disposable Cartridge, single-use
• Corning X-WASH Control Module, rechargeable
• Corning X-WASH Docking Station, AC-powered
• X-SERIES® DataTrak Software
The Corning X-WASH Control Module component of the X-WASH System
is a microprocessor-controlled device, which works in combination with the
Corning X-WASH Disposable Cartridge during centrifugation to direct the
transfer of cells into a separate compartment within the Disposable Cartridge.
After centrifugation, the X-WASH Control Module is placed on the Corning
X-WASH Docking Station to download processing data using the X-SERIES
DataTrak Software.
Intended Use
The Corning X-WASH System is general lab equipment to be used to wash
and/or concentrate cell suspensions.
Overview
For the purposes of the intended use, the input volume is limited to a range
of approximately 40 mL to 240 mL, with an output max (or cell concentrate
volume) of approximately 40 mL. Average processing time is approximately
17 minutes (single wash).
The sample of thawed blood along with thaw media to be processed is
placed in the sterile, functionally closed X-WASH Disposable Cartridge for
processing. High-speed and low-speed centrifugation is used to separate
cells from cryoprotectant using a commercially available programmable
centrifuge, such as the Thermo Scientific Sorvall™ Legend™ XT or XTR, and
the Hettich ROTANTA 460.
NOTE: For the purpose of this instruction manual, thawed blood samples
will be used in all examples and process steps, with the goal of collecting
a cell fraction that has been washed and resuspended. Thawed blood
demonstrates the basic system operation. For information about specific
processing differences or requirements for other cellular products, please
contact Corning Scientific Support at USA/Canada: 1.800.492.1110 Option
3, +1.978.442.2200 Option 3, or email [email protected].
Outside of the US, visit www.corning.com/lifesciences or contact your local
support office (see the back of instruction manual).

5
Instruction Manual
During the initial high-speed portion of the centrifugation (2,000 RCF), the
cells in the thawed blood pellet at the base of the cone in the Disposable
Cartridge. The speed is then lowered to 50 x g, and the cells are directed
to the Disposable Cartridge harvest compartment, which has been pre-
filled with resuspension media. The bulk of media and cryopreservative is
retained in the central compartment of the cartridge.
Once the centrifuge cycle ends, the operator places the Control Module on
the Docking Station and follows the DataTrak software screen instructions
to download the processing data. The battery within the Control Module is
also recharged for the next blood separation procedure.
Symbol Keys
The following symbols and abbreviations are used on the Corning®
X-WASH® System labeling, packaging, or within this instruction manual.
Sterile uid path Sterile uid path
using irradiation
Expiration date Do not re-use
Non-pyrogenic Do not trash as municipal waste
Indicates that a product has
been evaluated to applicable
European directives
Batch code
Catalog number Serial number
Manufacturer Caution to be observed by the
user
Warning to be observed
by the user Temperature limit
Keep dry Humidity
Pressure Do not use if package is
damaged
Follow Instructions for Use Direct Current
Consult Instructions for Use

6CORNING X-WASH SYSTEM
Glossary of Definitions and Abbreviations
Below are abbreviations that are used in this Instruction Manual and their
associated definitions.
Term Denition
Cell Concentrate The targeted concentration of white blood cells separated from cryoprotectant
and media.
Control Module Provides the mechanisms that open and close the valve on the Disposable
Cartridge to direct components of blood to their respective compartments.
CSV Comma Separated Values
DataTrak Software Proprietary data management system which collects processing and system
information through a user interface and stores it in a searchable, sortable
database.
Disposable Cartridge Single-use device with a sterile, non-pyrogenic uid path.
Docking Station Provides communication link to DataTrak Software and enables charging of
the device battery.
IEC International Electrotechnical Commission
LED Light Emitting Diode
PC Personal Computer
PDF Portable Document Format
Corning® X-WASH®
System
Cell processing system that includes: Disposable Cartridge, Control Module,
Docking Station, and DataTrak Software
RCF Relative Centrifugal Force or g-force
RF Radio Frequency