CORNING X-LAB 6917 Manuale utente

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

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

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

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.

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.

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