CORNING 6928 Instruction Manual
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CORNING 6928 Instruction Manual

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

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  • Page 1 Corning ® X-WASH ® System Instruction Manual Catalog Numbers: 6928 6931 6929 6932 6930 6933...

  • Page 2: Table Of Contents

    Corning X-WASH System Operating Instructions . . . . . . . . . . . . . . . . . 28...

  • Page 3: Introduction

    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 .
  • Page 4 . 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 fluid path...
  • Page 5 . International Electrotechnical Commission Light Emitting Diode Personal Computer Portable Document Format Corning® X-WASH® Cell processing system that includes: Disposable Cartridge, Control Module, System Docking Station, and DataTrak Software Relative Centrifugal Force or g-force Radio Frequency CORNING X-WASH SYSTEM...
  • Page 6 978 .442 .2476 ScientificSupport@corning.com 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 •...
  • Page 7 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 .

  • Page 8: Safety

    • 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 .
  • Page 9 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 •...
  • Page 10 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 .
  • Page 11 . RF emissions CISPR 11 Class B The Corning X-WASH System is suitable for use in all establishments, including domestic establishments Harmonic emissions Class A...
  • Page 12 3 Vrms 3 Vrms Portable and mobile RF communications IEC 61000-4-6 equipment should be used no closer to any part of the Corning® X-WASH® Radiated RF 150 kHz to 80 MHz 3 V/m system, including cables, than the IEC 61000-4-3...

  • Page 13: Corning® X-Wash® System

    NOTE 2: These guidelines may not apply in all situations . Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 3.0 Corning® X-WASH® System The Corning X-WASH System is composed of the following components: Cat. No. Description...
  • Page 14 . The thawed sample and thaw media is transferred into the Disposable Cartridge through a 150 micron clot filter . The Corning Disposable Cartridge is latched into the Corning X-WASH Control Module for subsequent centrifugation following a preprogrammed profile described below .
  • Page 15 Dual Bag Spikes Clamp Clamps Needleless Port A The components of the Corning X-WASH 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, the central funnel compartment, and integrated pinch mechanisms .
  • Page 16 The Corning X-WASH 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 cell concentrate to the harvest compartment .
  • Page 17 • 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 Corning User Interface Label Battery Status Indicator Power Button Status Display...
  • Page 18 Corning® X-WASH® Docking Station The Corning X-WASH 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 .
  • Page 19 Label Corning® X-Balance Ring Kit The Corning X-Balance Rings are specifically designed for use with the Corning X-WASH® System for balancing the contents of the centrifuge cup prior to centrifugation . They are provided in 2 .5 and 7 .4 gram weights .
  • Page 20 On/Off Power Switch turns the X-Mixer on or off . Press to turn on (I) or off (O) . The Power Cord Connection is used for connection to the external power source via AC/DC adapter and the power cord . Corning® X-WASH® Accessory Kit Air tubing with Disposable...

  • Page 21: X-Series® Datatrak Software

    . Lab Technician User The Lab Technician User can download the data from the Corning X-WASH 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 .
  • Page 22 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 .
  • Page 23 Preferences Section The PREFERENCES section allows the Administrator, Lab Technician, and Supervisor to configure the software as indicated below . Click the SUBMIT EDIT button to accept the entry or the CANCEL button to cancel the entry . CORNING X-WASH SYSTEM...
  • Page 24 The OPERATIONS mode includes the three sections of operating functions: PROCESS, HISTORY, and PREFERENCES . The PROCESS section allows the user to download the data from the Corning® X-WASH® System components . Users cannot edit the data . Click the LOGOUT button to exit the OPERATIONS AREA and return to the login screen .
  • Page 25 (i .e ., if the X-WASH SYSTEM SECTION is selected, the download data from the Control Modules will be listed) . To review a PROCESSING REPORT, click the appropriate UNIT ID . The Control Module PROCESSING REPORT contains the following information: CORNING X-WASH SYSTEM...
  • Page 26 DATA TRANSFER TIME The date and time when the download occurred . CONTROL MODULE The serial number of the Corning® X-WASH® Control Module used for the harvest process . CENTRIFUGE The serial number of the centrifuge used for the harvest process .

  • Page 27: Corning X-Wash System Operating Instructions

    • Corning X-WASH Accessory Kit • Peristaltic Pump (optional) • Unit ID label generator Materials • Corning X-WASH Disposable Cartridge • Corning X-Counterweight (if processing an odd number of Disposable Cartridges) • Balance rings • Syringes • Labels CORNING X-WASH SYSTEM...
  • Page 28 . 1 . Remove the X-WASH Disposable Cartridge from its packaging . Visually inspect the Corning Disposable Cartridge for damage or irregularities . The 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 or components are missing .
  • Page 29 Pre-filling the Corning® X-WASH® Disposable Cartridge for Processing (Optional) Perform these steps in a biological safety cabinet using aseptic techniques to maintain sterility . 1 . Grasp the harvest chamber access tube (tube is opposite of the label), and release it gently from the three clamps .
  • Page 30 5 . Replace the port cap and reinsert the tube into the four clamps . Filling the Corning® X-WASH® Disposable Cartridge for Processing 1 . Obtain sample bag to be processed and insert bag spikes into the freeze bag .
  • Page 31 . Separate and remove the tubing above the seal . Inadequate tube length on the input tubing can lead to Disposable Cartridge damage (including potential sample exposure) or centrifuge errors . 7 . Replace blue cap on air filter . CORNING X-WASH SYSTEM...
  • Page 32 8 . Mix the sample by rocking the Cartridge five times on its horizonal axis . 9 . Once the Disposable Cartridge has been sufficiently mixed, an optional sample may be taken using the needleless port by removing cap on air filter, attaching a luer-lock syringe and withdrawing the sample .
  • Page 33 2 . Turn OFF the Control Module by pressing and holding the POWER button for approximately 3 seconds . Confirm that there are no lighted indicators . Now the Control Module is ready to latch with the Disposable Cartridge . CORNING X-WASH SYSTEM...
  • Page 34 3 . Latch the Disposable Cartridge to the Control Module by aligning the lot number label with the center of the user interface label and then pushing down firmly . The Cartridge clips will audibly click when properly latched . 4 .
  • Page 35 X-Counterweight 40 to 110 111 to 170 MEDIUM 171 to 240 HIGH Failure to properly balance within the centrifuge can cause centrifuge errors and/or damage to the system components . 4 . Close the centrifuge lid . CORNING X-WASH SYSTEM...
  • Page 36 5 . Select the program code that represents the pre-programmed specifications that were setup on the day of install, and press the start button on the centrifuge . See Table below for program example . Centrifuge Programming Example for Blood Thaw Wash Centrifugation Example Centrifuge Program Program Number Acceleration...
  • Page 37 Multiple Washes Using Corning® X-Mixer and Corning X-WASH® Accessories 1 . Obtain sample bag to be processed . Attach the sample bag to the Disposable Cartridge via sterile welding to the input line above the clot filter, attaching it to the needleless port or spiking into the sample bag .
  • Page 38 7 . Verify that pump display reads 200 rpm . Press the direction button so the light on the counterclockwise arrow is illuminated . Press the START button to apply NEGATIVE pressure to the cartridge, verifying that that the START LED is illuminated, the pump activates, and the sample enters the main chamber of the Disposable Cartridge .
  • Page 39 . Press the START button to apply POSITIVE pressure to the cartridge and verify that the START LED is illuminated, the pump activates, and waste media enters the waste bag . CORNING X-WASH SYSTEM...
  • Page 40 17 . Stop the pump when waste is finished transferring into the waste bag or when air starts to enter the waste bag by pressing the STOP button on the pump . Clamp input line to prevent movement of liquid between Disposable Cartridge and bag .
  • Page 41 23 . Attach media bag to Disposable Cartridge via sterile welding to the input line or attaching it to the needleless port . 24 . Transport Disposable Cartridge and media bag to peristaltic pump, verify that air filter cap is CORNING X-WASH SYSTEM...
  • Page 42 removed, and attach air tubing from the peristaltic pump to the filter on the Disposable Cartridge lid . Make sure the air tubing does not become crimped . Make sure the Disposable Cartridge remains upright throughout this process . 25 . Verify that pump display reads 200 rpm . Press the direction button so the light on the counterclockwise arrow is illuminated .
  • Page 43 . The needleless port and the blue cap leading to the main chamber should be on the outer edge of the centrifuge bucket . 31 . Close the lid and start the centrifuge CORNING X-WASH SYSTEM...
  • Page 44 32 . Repeat Steps 9-31 for any additional wash cycles . 33 . Once centrifugation is complete, open the centrifuge lid and carefully remove the Disposable Cartridge/Control Module assembly . 34 . Verify that the Control Module displays a “P” (Pass) in the window .
  • Page 45 The harvested cells are now available for the next step in your process . 7 . Discard the Disposable Cartridge per established procedures for handling biohazardous materials . 8 . Start the computer and open the DataTrak application . CORNING X-WASH SYSTEM...
  • Page 46 User ID and password, then click the SUBMIT button . Downloading Corning® X-WASH® Control Module Data 1 . Verify that the Corning X-WASH Docking Station is connected to the computer via the USB cable . 2 . Click on DATA DOWNLOAD on the left navigation pane .
  • Page 47 Accessing the History Section 1 . Click HISTORY on the lower left navigation pane . 2 . Click the UNIT ID of the report to be viewed . The report is displayed in a new window . CORNING X-WASH SYSTEM...
  • Page 48 Adding User Notes (Optional) 1 . To add comments to the report, place the cursor in the USER NOTES field . 2 . Enter comment . The SAVE USER NOTE button appears after initial entry . 3 . Click the SAVE USER NOTE button to retain the comment . The comment is documented with the date/time and logged-in user for each entry saved .
  • Page 49 1 . To log out of the DataTrak program, select LOGOUT in the upper right corner, which will return you to the initial login screen . 2 . To exit the DataTrak program, close the window by selecting the “X” in the upper right corner of the window . CORNING X-WASH SYSTEM...

  • Page 50: X-Series Datatrak Software: System Setup

    6.0 X-SERIES® DataTrak Software: System Setup Corning® X-WASH® Docking Station Handle the X-WASH Docking Station with care . The X-WASH Control Module battery should only be charged in the X-WASH Docking Station overnight or for at least 6 hours prior to initial use .
  • Page 51 3 . Ensure that administrator access is available . The software will be installed by a Corning technical representative . 4 . The users, components of the X-WASH System, and the centrifuges must be entered into the software before processing data can be downloaded .

  • Page 52: X-Series Datatrak Administration Mode

    7.0 X-SERIES® DataTrak Administration Mode Only users with Administrator roles can access the software’s administration mode . Verify all data entries prior to submitting, as they cannot be edited once accepted by the software . Software Login 1 . Double click the DataTrak icon located on the desktop to launch the software .
  • Page 53 3 . Click the SUBMIT EDIT button to reset the password to the default setting, or click the cancel button to cancel the edit . Registering and Editing a Corning® X-WASH® Control Module 1 . Place an unregistered X-WASH Control Module in an X-WASH Docking Station that is connected to the computer .
  • Page 54 11 . To return a Control Module into use after maintenance, click the ID of the appropriate Control Module in the table . 12 . Click the ACTIVE checkbox and then select the CALIBRATION DUE DATE from the dropdown menu . 13 .
  • Page 55 10 . To save the change, click the SAVE CENTRIFUGE button or click the CLEAR button to clear the change . Adding and Editing a Corning® X-WASH® Disposable Cartridge Lot 1 . Click DISPOSABLE CARTRIDGE on the left navigation pane .
  • Page 56 8 . Enter the quantity in the QUANTITY field as applicable . 9 . To save changes, click the SAVE CARTRIDGE button, or to clear all changes made, click the CLEAR button . Editing Preferences 1 . Click the PREFERENCES button on the lower left navigation pane . 2 .
  • Page 57 1 . To exit the DataTrak System ADMINISTRATION mode, click the LOGOUT icon in the upper right corner to return you to the initial login screen . 2 . To exit the software completely, click the “X” in the upper right section of the window . CORNING X-WASH SYSTEM...

  • Page 58: X-Series Datatrak Operations Mode

    . Re-enter the correct User ID and password, then click the SUBMIT button . Downloading Corning® X-WASH® Control Module Data 1 . Verify that the X-WASH Docking Station is connected to the computer via the USB cable .
  • Page 59 2 . Enter comment . The SAVE USER NOTE button appears after initial entry . 3 . Click the SAVE USER NOTE button to retain the comment . The comment is documented with the date/time and logged-in user for each entry saved . CORNING X-WASH SYSTEM...
  • Page 60 Saving or Printing the File 1 . To save the processing report as a PDF file, click the SAVE AS PDF button . 2 . Select the file location and edit the file name as needed . 3 . Click the SAVE button . 4 .
  • Page 61 1 . To log out of the DataTrak program, select LOGOUT in the upper right corner, which will return you to the initial login screen . 2 . To exit the DataTrak program, close the window by selecting the “X” in the upper right corner of the window . CORNING X-WASH SYSTEM...

  • Page 62: Maintenance, Cleaning, And Disinfection

    Any electromechanical device disposal must follow local regulations . If an error code is experienced, first consult Troubleshooting (Chapter 10) of this manual . If the problem persists, call Corning Scientific Support at 800 .492 .1110, +1 .978 .442 .2200 (USA/Canada) or contact your local Corning sales office, or send an email to ScientificSupport@corning.com.

  • Page 63: Troubleshooting

    In the event that liquids enter the X-WASH Control Module, contact Corning Scientific Support for assistance . Corning X-WASH Control Module Alerts and Error Codes The table below identifies the displayed alerts and error codes for the Control Module and appropriate user actions .
  • Page 64 Action by User Place the same loaded Corning® X-WASH® Disposable Depletion valve The RBC pinch valve has failed to open when Cartridge on a new Corning X-WASH Control Module open failed directed . and repeat the run. Contact Corning Scientific Support for assistance .
  • Page 65 • To view latest log file, press: Ctrl-Shift-Alt-V and a window will pop up . • To save all log files in a zip, press: Ctrl-Shift-Alt-Z and save file . Sample Retrieval from the Corning® X-WASH® Disposable Cartridge This section describes the steps to perform in the event that the separated components need to be removed from the individual Disposable Cartridge compartments for either reprocessing or sample analysis .

  • Page 66: Technical Support

    11.0 Technical Support All Corning® X-WASH® Systems purchased will be supplied with a copy of the X-WASH System Instruction Manual . In addition, Corning technical staff will provide end-user training prior to the system’s use and will be available for specific questions or clarifications .
  • Page 67 Corning® X-WASH® Control Module Feature Specification Height 2 .3 in . (5 .8 cm) Diameter 3 .92 in . (9 .96 cm) Weight 0 .66 lbs . (0 .3 kg) Battery Voltage 3 .7 volt nominal Battery Pack Lithium ion, rechargeable...
  • Page 68 Corning® X-WASH® Docking Station Feature Specification Height 1 .9 in . (4 .93 cm) Width 5 .3 in . (13 .5 cm) Depth 5 .2 in . (13 .2 cm) Weight 2 .2 lbs . (1 .01 kg) Docking Station Power Input...
  • Page 69 X-SERIES® DataTrak Software Computer System Requirements A computer, printer, USB hub, and barcode scanner are not provided with the software . A Corning representative will install and configure the software application for customer use . The minimum required computer specifications are: •...
  • Page 70 Centrifuge To ensure proper operation of the Corning® X-WASH® System, the Thermo Scientific Sorvall™ Legend™ XT or XTR, or the Hettich ROTANTA 460 centrifuge is necessary, therefore it is important to be able to order the correct centrifuge . Ordering Information...
  • Page 71 Follow the Hettich Instruction Manuals for setup . Tube Sealer To ensure proper operation of the Corning X-WASH System, the Genesis BPS Rapid Seal II™ SE540 tube sealer is necessary, therefore it is important to be able to order the correct tube sealer .

  • Page 72: Product Disposal

    Should you decide that you want to use the product for any intended use other than that made by Corning then you accept that Corning does not make or support that claim and that you as the user are responsible for any testing, validation, and/or regulatory submissions that may be required to support the safety and efficacy of your intended application .

This manual is also suitable for:

69296930693169326933

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