CORNING 6928 Manual de usuario

Corning®

X-WASH®System

Instruction Manual

Catalog Numbers:

6928

6929

6930

6931

6932

6933

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

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

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).

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

Instruction Manual

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-WASH® System. The contents of this manual

are provided “as is” and without warranties of any kind, either express or

implied.

The Corning X-WASH System is covered by specific and limited warranties,

as described in this chapter.

For questions about Corning X-WASH 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

f 978.442.2476

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

8CORNING X-WASH SYSTEM

Limited Warranty

Corning warrants to the original purchaser that the Corning® X-WASH®

Control Module and X-WASH Docking Station (referred to as a “X-WASH

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-WASH Instrument does not conform to the foregoing

warranty, Corning will, at its option, repair the nonconforming X-WASH

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-WASH 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-WASH 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-WASH Instrument will be replaced or repaired at the cost of the end-

user.

Any alterations or modification made to an X-WASH 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.

Instruction Manual

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-WASH® System.

• Always follow internal policy for personal protective equipment such as

gloves, gowns, eyewear, or masks when using the X-WASH System.

• Always follow established procedures for handling and discarding

biohazardous materials.

• The X-WASH System has been optimized for 40 mL to 240 mL input

volume and other volumes will yield unknown results.

• Operators should be trained on the X-WASH System prior to initial use

• Follow aseptic procedures.

• The Corning X-WASH 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.

• Do not exceed 2,000 RCF centrifugation at any time as an inappropriate

transfer of cellular components between compartments may occur,

causing a loss of cell functionality requiring the sample to be discarded.

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-WASH System prior

to initial use.

• Do not insert any objects, including fingers, into the Corning X-WASH

Control Module while powered on or at any other time.

10 CORNING X-WASH SYSTEM

• Follow aseptic procedures.

• Avoid liquid contact with the X-WASH Control Module internal

components. In the event that liquids enter the X-WASH Control Module,

contact Corning.

• Handle the X-WASH Control Module and Docking Station with care.

• 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-WASH System as this

may cause damage.

• Keep the X-WASH 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-WASH Control Module battery should be charged in the X-WASH

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-WASH® Control Module is OFF before latching the X-WASH

Disposable Cartridge

• Corning X-WASH Disposable Cartridge is fully latched into the X-WASH

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-WASH Control Module, and unplug

the X-WASH Docking Station.

• The X-WASH System has been optimized for 40 mL to 240 mL input

volume and other volumes will yield unknown results.

Instruction Manual

Standards and Regulations

The Corning® X-WASH® 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.

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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