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
1.0
2.0
3.0
4.0
5.0
6.0
7.0
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

3
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

5
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.

7
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.

9
Instruction Manual
NOTE: The EQUIPMENT is intended for use in the electromagnetic environment specified
below. The customer or the user of the EQUIPMENT should assure that it is used in such
an environment.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions for All Manufacturer’s Equipment and
Manufacturer’s Systems
Emissions Test Compliance Electromagnetic Environment Guidance
RF emissions CISPR 11 Group 1 The Corning® X-LAB® System uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions CISPR 11 Class B The Corning X-LAB System is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low
voltage power supply network that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuations/icker
emissions IEC 61000-3-3
Complies
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for All Manufacturer’s Equipment and
Manufacturer’s Systems
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete, or ceramic tile. If
oors are covered with synthetic material, the relative
humidity should be at least 30%.
Electrical fast transient/
burst IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to earth
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and volt-
age variations on power
supply input lines IEC
61000-4-11
<5% UT (>95% dip in
UT) for 0,5 cycles
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip in
UT) for 5 s
<5% UT (>95%
dip in UT) for 0,5
cycles
40% UT (60% dip
in UT) for 5 cycles
70% UT (30%
dip in UT) for 25
cycles
<5% UT(>95% dip
in UT) for 5 s
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the
Corning X-LAB System requires continued operation
during power mains interruptions, it is recommended
that the X-LAB System be powered from an
uninterruptible power supply or a battery.
Power frequency (50/60
Hz) magnetic eld IEC
61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should be at
levels characteristic of a typical location in a typical
commercial or hospital environment.
NOTE: UT is the A.C. mains voltage prior to application of the test level.

10 CORNING X-LAB SYSTEM
NOTE: The EQUIPMENT is intended for use in the electromagnetic environment specified
below. The customer or the user of the EQUIPMENT should assure that it is used in such
an environment.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for Equipment and Systems that are not
Life Supporting
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the Corning®
X-LAB® system, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2,5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from xed RF transmitters, as determined
by an electromagnetic site surveya, should be less than the
compliance level in each frequency rangeb.
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reection from structures, objects and people.
aField strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered.
If the measured eld strength in the location in which the X-LAB System is used exceeds the applicable RF compliance level
above, the X-LAB System should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the X-LAB System.
bOver the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

11
Instruction Manual
NOTE: The X-LAB System is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the X-LAB System can
help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the X-LAB System
as recommended below, according to the maximum output power of the communications
equipment.
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Corning
X-LAB System
Rated Maximum
Output Power of
Transmitter W
Separation Distance According to Frequency of Transmitter M
150 kHz to 80 MHz
d = 1.2 √P
80 MHz to 800 MHz
d = 1.2 √P
800 MHz to 2,5 GHz
d = 2.3 √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection
from structures, objects and people.
3.0 Corning® X-LAB® System
The Corning X-LAB System is composed of the following components:
Cat. No. Description
5711 Corning X-LAB Disposable Cartridge
6917 Corning X-LAB Control Module with associated rmware
6918 Corning X-LAB Docking Station with associated rmware
6930 X-SERIES DataTrak Software
Corning provides the following suggested products for use with the
Corning X-LAB System:
Cat. No. Description
6923 Corning X-Balance Ring Kit
6943 Corning X-Counterweight

12 CORNING X-LAB SYSTEM
The Corning® X-LAB® System requires the following instrumentation for operation. These
are not provided by Corning:
• Programmable centrifuge with 750 mL buckets (Thermo Scientific Sorvall™ Legend™ XT or
XTR, Hettich ROTANTA 460)
• Computer (e.g., desktop, laptop PC, or tablet) with Windows® 7 or 10 Operating System
and at least one available USB port (additional USB port required for optional barcode
scanner)
• Tube Sealer (Genesis Rapid Seal II™ SE540)
Materials and equipment that are required but not supplied:
• 40 mL to 240 mL of peripheral blood to be processed
• Biological safety cabinet or clean room area
• Digital scale
• Label printer(s) for component labeling (if applicable)
• Syringes for sample (if applicable)
• Labels for components and sample tubes (if applicable)
Corning X-LAB Disposable Cartridge
The Corning X-LAB Disposable Cartridge is a dedicated sterile, plastic, single-use processing
container for 40 mL to 240 mL of blood and comprises the fluid path of the system. The source
material is transferred into the Disposable Cartridge through a 150 micron clot filter. The
Corning Disposable Cartridge is latched into the Corning X-LAB Control Module for subsequent
centrifugation following a preprogrammed profile described below. Integrated within the
Disposable Cartridge is a mechanism that pinches or releases the tubing, allowing for transfer
of the cellular components during centrifugation. The Control Module manages this operation.
Peripheral Blood Centrifuge Profile Example
• The centrifuge accelerates to 2,000 RCF and the blood or mixture of blood marrow
stratifies into a packed red blood cell layer, a MNC layer, and a plasma layer in order of
decreasing density.
• The centrifuge then lowers to 50 RCF and the bulk of the RBCs are transferred through
transfer tubing to the RBC depletion chamber.
• The centrifuge then accelerates to 1,000 RCF for further stratification of the cells in the
processing compartment.
• The centrifuge then lowers to 50 RCF and the MNC fraction is transferred through
transfer tubing to the Harvest Compartment leaving the bulk of plasma and platelets
retained in the processing compartment.
• The centrifuge decelerates and stops spinning, the MNC can now be removed, and
samples of the RBC and plasma can be obtained.

13
Instruction Manual
Corning® X-LAB® Disposable Cartridge Components
Input Spike
Needleless
Port
Air Filter
Disposable
Cartridge Housing
Sample Access Tube
Clot Filter
Hydrophilic Filter
Clamp
The components of the Corning X-LAB Disposable Cartridge are described below:
• Air Filter: A 0.2 micron hydrophobic filter that facilitates air management during filling.
• Disposable Cartridge Housing: Contains the individual harvest compartments (RBC and
Harvest), the central funnel compartment, and integrated pinch mechanisms.
• Sample Access Tube(s): For the collection of harvested cells or RBC samples, the RBC
sample access tube is located adjacent to the lot number label; while the harvest chamber
sample access tube is located on the opposite side of the lot number label.
• Input Spike: Used to facilitate the loading of blood into the Corning Disposable Cartridge.
• Hydrophilic Filter: A 0.2 micron hydrophilic filter for addition of solutions (if applicable).
• Needleless Port: Used for sample removal.
• Clot Filter: A 150 micron filter to remove particles from blood or blood and bone marrow
mix during sample input.
• A pinch Clamp is used to control fluid flow.

14 CORNING X-LAB SYSTEM
Corning® X-LAB® Control Module
The Corning X-LAB Control Module is a battery-operated, microprocessor-controlled,
electromechanical device with two motor/gear/cam assemblies that rotate in order to
pinch or release tubing in the Corning Disposable Cartridge to direct the stratified red blood
cells and harvested MNCs to their respective compartments.
The X-LAB Control Module is also equipped with an accelerometer to measure acceleration
and four optical sensors that detect interfaces between the RBC and MNC populations, all
powered by a lithium ion battery. The paired sensors can detect the boundary between
the concentrated red blood cell layer and the MNC layer when the passage of infrared light
is blocked, then unblocked. The Control Module uses the detected boundary to open and
close the transfer tubes in the Disposable Cartridge. The Control Module’s firmware gathers
and stores the accelerometer’s output and the timing and release of the pinch mechanism
during each processing run for upload to the X-SERIES DataTrak Software.
Corning X-LAB Control Module Components
Electrical Connectors
Device Information Label
Serial Number Label
User Interface Label
Orientation Point Optical Sensors/
Receivers Latch Point
for Disposable
Cartridges
• Optical Sensors and Receivers: Four optical sensors and receivers that detect the cell
interfaces during centrifugation
• Latch Point for Disposable Cartridges: The two connections for latching the Disposable
Cartridge to the Control Module
• Disposable Cartridge Orientation Points: The three points for the Disposable Cartridge
feet that insure correct orientation when connecting
• Device Information Label: Provides information specific to the Control Module as well as
Corning contact information
• Electrical Connectors: The connectors that make contact with the Docking Station and
facilitate data transmission and the Control Module battery charging
• Serial Number Label: Control Module barcode and human readable text label
• User Interface Label: Contains the power button, as well as displays battery status, error
codes, and power status

15
Instruction Manual
Corning User Interface Label
Battery Status Indicator Power Button Status Display
Attention IndicatorPower Status Indicator
Battery Status Indicator
When power button is pressed, steady green indicates that the battery has a sufficient
charge to perform a harvest process.
When power button is pressed, steady red indicates that the battery is insufficiently
charged. The operator should immediately charge the battery.
When the Control Module is placed on the Docking Station for charging, the Battery Status
Indicator will blink at the following rates in response to battery charge levels:
• Green 1-blink pattern Leave on Docking Station to charge
• Green 2-blink pattern Charge soon
• Green 3-blink pattern Ready to use
• Green Steady Fully charged and ready to use
Power Button
• Press this button for approximately one (1) second to power ON the Control Module.
• Press and hold for approximately three (3) seconds to power OFF the Control Module.
Power Status Indicator
• Green indicates that the Control Module is powered ON.
• No illumination indicates that the Control Module is powered OFF.
Status Display
Displays the status or error code of the Control Module. Standard Status Codes are described
below. Refer to Troubleshooting (Chapter 10) for error codes and additional information.
Character Denition Process Description
0Ready to operate The Control Module is ready for processing
P Pass The process is has completed successfully
dP Data present The data needs to be downloaded in preparation for a new
processing run

16 CORNING X-LAB SYSTEM
Device Information
Label
Link
Attention Indicator
• Green indicates that the Control Module is ready for processing or has successfully
completed a centrifugation process.
• Red indicates that the Control Module has failed a centrifugation process, has gone into
an error state, or the Control Module was powered down prior to downloading the data.
The operator should assess which of these situations has occurred, and take appropriate
remedial actions (see Troubleshooting Chapter 10)
Corning® X-LAB® Docking Station
The Corning X-LAB Docking Station is a multifunctional system component that concurrently
charges the battery of the Corning Control Module and enables transmission of data to and
from the Control Module onto a host Windows® computer.
Docking Station Components
The components of the Docking Station are described below:
• Connector Pins: Retractable pins which align and contact with electrical connectors on the
bottom of the docked Control Module for data communication and battery charging.
• User Interface Label: Identifies the device and allows the user to see an LED with three states:
• Green indicates that a Control Module is present and charging.
• Red indicates that no Control Module is present, or the Control Module is
present but not seated properly, or Control Module is not functional. The
operator should assess which of these situations has occurred and take
appropriate actions to remedy.
• No illumination indicates that the Docking Station is not receiving power.
• USB Data Port: Port for connection to the host computer via the USB cable.
• Power Cord Port: Port for connection to the external power source via the
power cable. To remove mains power, unplug the cable from the wall.
• Device Information Label: Provides information specific to the Docking
Station as well as Corning contact information.
• USB Cable: Connects the Docking Station to the Windows Computer or
tablet to allow for the transfer of Control Module data.
Accessories
Corning® X-Balance Ring Kit
The Corning X-Balance Rings are specifically designed for use with the Corning
X-LAB® System for balancing the contents of the centrifuge cup prior to
centrifugation. They are provided in 2.5 and 7.4 gram weights.
Corning X-Counterweight
The Corning X-Counterweight set is specifically designed for use with the Corning
X-LAB System for balancing the contents of the centrifuge prior to centrifugation.
Cat. No. Description Input Volume
6943 Corning X-Counterweight 40 to 240 mL
Connector Pins
User Interface Label
USB Data Port
Power Cord Port
USB Cable
Corning X-Balance
Ring Kit

17
Instruction Manual
4.0 X-SERIES® DataTrak Software
The X-SERIES DataTrak Software is the application that provides the interface between
the operator and the Corning X-LAB System through a host computer. It downloads
processing and system information and stores it in a searchable, sortable database on the
host computer. The data collected includes information gathered during each processing
run and serves as a means to support GMP compliance. The DataTrak System Software
includes the Microsoft® MS SQL Server as the database server for a host computer.
X-SERIES DataTrak Software Use
The DataTrak Software is intended for use with X-SERIES products only. X-SERIES
products include Corning X-LAB®, Corning X-WASH®, and Corning X-BACS™ systems.
Software users should be familiar with the applicable X-LAB System components prior
to using the DataTrak Software. DataTrak is not intended for use with computer system
specifications other than those listed under Computer System Requirements in Chapter
12 Specifications.
User Profiles
The DataTrak Software has three user profiles that are designed to restrict software
operations based on level of responsibility.
Lab Technician User
The Lab Technician User can download the data from the Corning X-LAB System
components, view the data history, customize their software views, and change their
password. In addition, they can also save report as PDF, add notes to report and print,
as well as view raw Control Module data.

18 CORNING X-LAB SYSTEM
Lab Supervisor User
The Lab Supervisor User level has the same abilities as the Lab Technician User profile with
the addition of the ability to approve reports.
Administrator User
The Administrator User profile is a management function level only. The Administrator
User can add, edit, or inactivate users, serial numbers of the system equipment, and lot
numbers of the disposable components. The Administrator User does not have the ability to
download data from the System components or view data history. This ability is restricted
to the Lab Supervisor and Lab Technician User profile.
X-SERIES® DataTrak Software Modes
The DataTrak Software is divided into two modes of functionality: Administration and
Operations.
Administration Mode
The ADMINISTRATION mode includes two sections of operating functions: Administration
and Preferences. The active section will be highlighted in yellow. The Administration
section provides the data record of users, equipment, and materials. Once data is entered
it cannot be deleted – only edited or made inactive. Click the LOGOUT button to exit the
administrative area and return to the login screen.
Administration Section
The Administration section includes the following selections on the left side of the display
screen for administrative functions. Selected sections will be highlighted in yellow.