CORNING X-LAB 6917 User manual

Corning®
X-LAB®System
Instruction Manual
Catalog Numbers:
6917
6918
6930
6924
6925
6926

Table of Contents
Introduction ..............................................................1
Safety. ....................................................................6
Corning® X-LAB® System. .................................................11
X-SERIES® DataTrak Software .............................................17
Corning X-LAB System Operating Instructions .............................23
X-SERIES DataTrak Software: System Setup ................................35
X-SERIES DataTrak Administration Mode ...................................37
X-SERIES DataTrak Operations Mode ......................................43
Maintenance, Cleaning, and Disinfection ..................................47
Troubleshooting..........................................................48
Technical Support ........................................................51
Specifications ............................................................51
Product Disposal .........................................................56
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2.0
3.0
4.0
5.0
6.0
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8.0
9.0
10.0
11.0
12.0
13.0

1
Instruction Manual
1.0 Introduction
The Corning® X-LAB® System is a semi-automated, functionally closed, Ficoll-free system
that processes blood, bone marrow, and leukapheresis units to isolate target cells. The
X-LAB System is used with a commercially available centrifuge and personal computer
(not supplied).
The system consists of four major components:
• Corning X-LAB Disposable Cartridge, single-use
• Corning X-LAB Control Module, rechargeable
• Corning X-LAB Docking Station, AC-powered
• X-SERIES® DataTrak Software
The Corning X-LAB Control Module component of the X-LAB System is a microprocessor-
controlled device, which works in combination with the Corning X-LAB Disposable Cartridge
during centrifugation to direct the transfer of red blood cells and concentrated mononuclear
fraction (cell concentrate) into separate compartments within the Disposable Cartridge. After
centrifugation, the X-LAB Control Module is placed on the Corning X-LAB Docking Station to
download processing data using the X-SERIES DataTrak Software.
Intended Use
The Corning X-LAB System is general lab equipment to be used to isolate target cells from
blood and blood products.
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.
The sample of cellular product or blood or bone marrow to be processed is placed in the
sterile, functionally closed X-LAB Disposable Cartridge for processing. High-speed and low-
speed centrifugation is used to separate cells of interest 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, peripheral blood samples will be used
in all examples and process steps, with the goal of collecting a mononuclear cell fraction.
Peripheral 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).

2CORNING X-LAB SYSTEM
During the initial high-speed portion of the centrifugation (2,000 RCF), the cells in the
sample are stratified by density into three components in the Disposable Cartridge: (1)
red blood cells and granulocytes, (2) mononuclear cells, and (3) plasma and platelets. The
speed is then lowered to 50 x g and, during this first low-speed centrifugation, the bulk of
the red blood cells are directed to the red blood cell compartment. The speed is increased
briefly (1,000 x g), and then lowered to 50 x g, during which time a programmed volume
of mononuclear cells (along with a small amount of red blood cells and some plasma) are
directed to the cell-concentrate compartment of the Disposable Cartridge. The bulk of
plasma along with the platelets are retained in the Cartridge’s central compartment.
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-LAB® 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
Authorized representative in
the European Community
Catalog number Batch code
Manufacturer Serial number
Warning to be observed
by the user
Caution to be observed by
the user
Keep dry Temperature limit
Pressure Humidity
Follow Instructions for Use Do not use if package is
damaged
Consult Instructions for Use Direct Current

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Instruction Manual
Glossary of Definitions and Abbreviations
Below are abbreviations that are used in this Instruction Manual and their associated
definitions.
Term Denition
Cell Concentrate A concentration of white blood cells. The targeted stem cell-rich mononuclear cell (MNC)
fraction is found in this blood component.
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-LAB® 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

4CORNING X-LAB SYSTEM
Warranties
Corning Incorporated has reviewed the contents of this manual. All statements, technical
information and recommendations contained in this manual are current and believed
to be reliable. Manual contents are not intended to be and should not be understood as
representations or warranties for the Corning® X-LAB® System. The contents of this manual
are provided “as is” and without warranties of any kind, either express or implied.
The Corning X-LAB System is covered by specific and limited warranties, as described in this
chapter.
For questions about Corning X-LAB System warranties, or if warranty repairs are needed,
contact an authorized distributor or Corning Incorporated.
Fill out the box below for future reference:
Distributor Name _________________________________________________________________________
Contact Name ____________________________________________________________________________
Email ___________________________________________________________________________________
Phone Number____________________________________________________________________________
Hours of Operation ________________________________________________________________________
Corning Incorporated
Life Sciences
836 North St.
Building 300, Suite 3401
Tewksbury, MA 01876
t 800.492.1110
t 978.442.2200
Scienti[email protected]
www.corning.com/lifesciences
Outside of the U.S., visit www.corning.com/lifesciences or contact your local support office
(see the back of instruction manual).
When calling for service or repairs, have available:
• Detailed information about the problem
• Serial numbers and date/place of purchase of Control Module and Docking Station
• Disposable lot number and expiration date
• Service record given at time of training

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Instruction Manual
Limited Warranty
Corning warrants to the original purchaser that the Corning® X-LAB® Control Module and
X-LAB Docking Station (referred to as a “X-LAB Instrument”) will be free from defects in
material or workmanship for one (1) year from date of shipment. Installation documents
must be completed and returned to Corning for the warranty to be recognized. Failure to
provide such documentation may result in the warranty being considered null and void.
In the event that an X-LAB Instrument does not conform to the foregoing warranty, Corning
will, at its option, repair the nonconforming X-LAB Instrument, provide a free replacement,
or grant you an appropriate credit. These alternatives shall be your sole and exclusive
remedy in the event of a failure to comply with the foregoing warranty.
Corning also warrants that replacement parts of the X-LAB Instruments will be free from
defects in material and workmanship for the remaining portion of the original warranty,
or, if longer, the minimum time required by applicable local law, from date of shipment of
replacement part.
X-LAB Instruments may fail or malfunction for reasons other than those caused by defects
in materials or workmanship (such as improper handling of the machine, misuse, accident,
or non-compliance with the Instruction Manual. Any such failure is not covered under the
Corning warranty and such X-LAB Instrument will be replaced or repaired at the cost of the
end-user.
Any alterations or modification made to an X-LAB Instrument (other than those made by
Corning) will render the warranty null and void.
Corning shall under no circumstances be liable to you or any other party, under any
circumstances, for any special, consequential, indirect or punitive damages such as loss
of capital, loss of use, substitute performance, loss of production, loss of profits, loss of
business opportunity, or any other claims for damages, even if such losses or damages are
reasonably foreseeable.
THE FOREGOING WARRANTIES, AS SET FORTH HEREIN, ARE EXCLUSIVE AND ARE IN LIEU
OF, AND YOU HEREBY WAIVE, ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OR WARRANTY OF NON-INFRINGEMENT.

6CORNING X-LAB SYSTEM
2.0 Safety
Warnings
A WARNING is a statement preceded by this symbol that alerts the user to the
possibility of injury, death, or other serious adverse reactions associated with the use
or misuse of the device.
• Read this instruction manual completely prior to using the Corning X-LAB System.
• Always follow internal policy for personal protective equipment such as gloves, gowns,
eyewear, or masks when using the X-LAB System.
• Always follow established procedures for handling and discarding biohazardous materials.
• The X-LAB System has been optimized for 40 mL to 240 mL input volume and other
volumes will yield unknown results.
• It is strongly recommended that users review the entire instruction manual prior to initial
system use.
• Operators should be trained on the X-LAB System prior to initial use
• Follow aseptic procedures.
• The Corning X-LAB Disposable Cartridge is a single-use device with a sterile, non-pyrogenic
fluid path. Do not use if packaging or product is damaged. Do not re-sterilize. Follow
internal policy for proper disposal of used Disposable Cartridge.
• No modification of this equipment is allowed. Only Corning authorized replacement parts
may be used.
• MEDICAL/LABORATORY ELECTRICAL EQUIPMENT needs special precautions regarding EMC
and needs to be installed and put into service according to the EMC information provided
in this manual.
Cautions
A CAUTION is a statement preceded by this symbol that alerts the user to the
possibility of a problem with the device associated with its use or misuse. Such
problems include device malfunction, device failure, damage to the device, or damage
to other property. The caution statement includes the precaution that should be
taken to avoid the hazard.
• Operators should be trained on the Corning® X-LAB® System prior to initial use.
• Do not insert any objects, including fingers, into the Corning X-LAB Control Module while
powered on or at any other time.
• Follow aseptic procedures.
• Avoid liquid contact with the X-LAB Control Module internal components. In the event
that liquids enter the X-LAB Control Module, contact Corning.
• Handle the X-LAB Control Module and Docking Station with care.

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Instruction Manual
• When connected to another device, the overall system must be evaluated to IEC 60601-1
3rd edition by the end user.
• Avoid dropping any of the components of the X-LAB System as this may cause damage.
• Keep the X-LAB Disposable Cartridge upright during and after filling to prevent fluids
from entering the 0.2 micron air filter as this may affect airflow through the filter.
• The X-LAB Control Module battery should be charged in the X-LAB Docking Station
overnight or for at least 6 hours prior to initial use.
• Only use the X-SERIES® DataTrak Software for downloading and storage of processing
information.
• Ensure that the computer is virus-free and has the latest update of antivirus software
prior to installing DataTrak Software.
• Update the operating system, service pack, and antivirus software on a regular basis.
• Do not leave an internet connection active while installing or using DataTrak.
• The user-provided Sample Label barcode must be in ISBT or code 128 format to be
compatible with the DataTrak Software.
• Prior to starting centrifugation, ensure the following:
- Battery status indicator on the Corning Control Module is green when placed on the
Corning Docking Station
- Corning X-LAB Control Module is OFF before latching the X-LAB Disposable Cartridge
- Corning X-LAB Disposable Cartridge is fully latched into the X-LAB Control Module
- Control Module is turned ON and “0” is displayed in the STATUS DISPLAY window
before centrifugation.
• Prior to cleaning, power down the X-LAB Control Module, and unplug the X-LAB Docking
Station.
Standards and Regulations
The Corning® X-LAB® System was tested and found to meet all regulations and
recommendations contained in this document, which are in compliance with the
appropriate international safety standards. This includes electrical instruments used in
laboratory, protection of laboratory staff and electrical safety.

8CORNING X-LAB SYSTEM
EMC Compliance Information
Unit complies with requirements within the European Union’s Electromagnetic
Compatibility (EMC) Directive 2014/30/EU. Limits are designed to provide reasonable
protection against harmful interference in a typical facility. This equipment generates, uses
and can radiate radio frequency energy, and, if not installed and used in accordance with
manufacturer’s instructions, may cause harmful interference to other devices in the vicinity.
There is no guarantee, however, that interference will not occur in a particular facility. If this
equipment causes interference with other devices, which may be determined by turning
equipment off and on, user is encouraged to try and correct interference by one or more of
the following measures:
• Reorient or relocate device receiving interference
• Increase separation between equipment
• Connect equipment to a different outlet than the one connected to the other device
• Consult manufacturer or field service technician for help
MEDICAL/LABORATORY ELECTRICAL EQUIPMENT needs special precautions regarding
EMC and needs to be installed and put into service according to the EMC information
provided in this manual.