CORNING X-LAB 6917 Instruction Manual
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CORNING X-LAB 6917 Instruction Manual

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

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Summary of Contents for CORNING X-LAB 6917

  • Page 1 Corning ® X-LAB ® System Instruction Manual Catalog Numbers: 6917 6924 6918 6925 6930 6926...

  • Page 2: Table Of Contents

    Corning X-LAB System Operating Instructions . . . . . . . . . . . . . . . . . .

  • Page 3: Introduction

    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...
  • 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-LAB® System labeling, packaging, or within this instruction manual . Sterile fluid path...
  • Page 5 Provides communication link to DataTrak Software and enables charging of the device battery . International Electrotechnical Commission Light Emitting Diode Personal Computer Portable Document Format Corning® X-LAB® System Cell processing system that includes: Disposable Cartridge, Control Module, Docking Station, and DataTrak Software Relative Centrifugal Force or g-force Radio Frequency Instruction Manual...
  • Page 6 978 .442 .2200 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 (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

    . 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 .
  • 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-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”...
  • Page 10 • 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 . CORNING X- LAB SYSTEM...
  • Page 11 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 .
  • Page 12 Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications equipment IEC 61000-4-6 should be used no closer to any part of the Corning® X-LAB® system, including cables, than the recommended Radiated RF 150 kHz to 80 MHz 3 V/m...

  • Page 13: Corning® X-Lab® System

    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 Separation Distance According to Frequency of Transmitter M...
  • Page 14 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 .
  • Page 15 . • 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) .
  • Page 16 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 .
  • Page 17 Corning User Interface Label Battery Status Indicator Power Button Status Display Power Status Indicator Attention Indicator Battery Status Indicator When power button is pressed, steady green indicates that the battery has a sufficient charge to perform a harvest process .
  • Page 18 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 .

  • Page 19: 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 .
  • Page 20 . 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 . CORNING X- LAB SYSTEM...
  • Page 21 User Profile Includes the following fields for data entry: USER ID, LAST NAME, FIRST NAME, PHONE NUMBER, USER ROLE and ACTIVE checkbox . Entered user information is displayed in a table below the data entry fields . Control Module Primary screen displays a REGISTER CONTROL MODULE button and a table with the registered CONTROL MODULE ID, RECEIPT DATE and ACTIVE state .
  • Page 22 HISTORY, and PREFERENCES . The PROCESS section allows the user to download the data from the Corning® X-LAB® System components . Users cannot edit the data . Click the LOGOUT button to exit the OPERATIONS AREA and return to the login screen . The PROCESS section includes the following process options for data entry .
  • Page 23 History Section The HISTORY section will display the data records for selected component (i .e ., if the X-LAB 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: Instruction Manual...
  • Page 24 DATA TRANSFER TIME The date and time when the download occurred . CONTROL MODULE The serial number of the Corning® X-LAB® Control Module used for the harvest process . CENTRIFUGE The serial number of the centrifuge used for the harvest process .

  • Page 25: Corning X-Lab System Operating Instructions

    Preparing the Disposable Cartridge Always follow established procedures for handling and disposing of biohazardous materials . 1 . Remove the X-LAB Disposable Cartridge from its packaging . Visually inspect the Corning Disposable Cartridge for damage or irregularities . Instruction Manual...
  • Page 26 3 . Remove cap from air filter on the top of the Disposable Cartridge and discard . 4 . Make sure to close the clamp above the clot filter . Pre-filling the Corning® X-LAB® Disposable Cartridge for Processing (Optional) 1 . Grasp the harvest chamber access tube (tube is opposite of the label), and release it gently from the three clamps .
  • Page 27 Filling the Corning® X-LAB® Disposable Cartridge for Processing NOTE: For closed processing, sterile weld peripheral blood bag to input line above the clot filter . See example below . NOTE: Obtain a sample prior to injecting sample into the Disposable Cartridge .
  • Page 28 6 . If an odd number of units are being processed, an X-Counterweight must be used to ensure accurate balancing of the centrifuge . Use an X-Counterweight with balance rings to provide a final balance within ±2 grams of each other . CORNING X- LAB SYSTEM...
  • Page 29 7 . Place balance rings, if needed, on the inside the rim of the centrifuge bucket with the Disposable Cartridge/Control Module assembly . Balance Ring Centrifugation Do not exceed 2000 RCF centrifugation at any time, as an inappropriate transfer of blood between compartments may occur, causing a loss of cell functionality and requiring the harvested cells to be discarded .
  • Page 30 3 . Add the X-Counterweight if processing an odd number of samples . Counterweight must be placed in the bucket opposite the X-LAB Cartridge as shown in the image below . X-Counterweight X-LAB Cartridge CORNING X- LAB SYSTEM...
  • Page 31 4 . Close the centrifuge lid . 5 . Select the program code that represents the pre-programmed specifications that were setup on the day of install (see table on page 47 for an example), and press the start button on the centrifuge . 6 .
  • Page 32 6 . Disconnect the syringe . 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- LAB SYSTEM...
  • Page 33 SUBMIT button . Downloading Corning® X-LAB® Control Module Data 1 . Verify that the Corning X-LAB Docking Station is connected to the computer via the USB cable . 2 . Click on DATA DOWNLOAD on the left navigation pane .
  • Page 34 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- LAB SYSTEM...
  • Page 35 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 36 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- LAB SYSTEM...

  • Page 37: X-Series Datatrak Software: System Setup

    6.0 X-SERIES® DataTrak Software: System Setup Corning® X-LAB® Docking Station Handle the X-LAB Docking Station with care . The X-LAB Control Module battery should only be charged in the X-LAB Docking Station overnight or for at least 6 hours prior to initial use .
  • Page 38 3 . Ensure that administrator access is available . The software will be installed by a Corning technical representative . 4 . The users, components of the X-LAB System, and the centrifuges must be entered into the software before processing data can be downloaded . To prepare the software, follow the directions described in DataTrak Administration Mode in Chapter 7 .

  • Page 39: 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 . 2 .
  • Page 40 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-LAB® Control Module 1 . Place an unregistered X-LAB Control Module in an X-LAB Docking Station that is connected to the computer .
  • Page 41 4 . To return a Control Module into use after maintenance, click the ID of the appropriate Control Module in the table . 5 . Click the ACTIVE checkbox and then select the CALIBRATION DUE DATE from the dropdown menu . 6 .
  • Page 42 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-LAB® Disposable Cartridge Lot 1 . Click DISPOSABLE CARTRIDGE on the left navigation pane .
  • Page 43 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 44 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- LAB SYSTEM...

  • Page 45: X-Series Datatrak Operations Mode

    Re-enter the correct User ID and password, then click the SUBMIT button . Downloading Corning® X-LAB® Control Module Data 1 . Verify that the X-LAB Docking Station is connected to the computer via the USB cable . 2 . Click on DATA DOWNLOAD on the left navigation pane .
  • Page 46 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- LAB SYSTEM...
  • Page 47 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 48 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- LAB SYSTEM...

  • Page 49: Maintenance, Cleaning, And Disinfection

    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 50: Troubleshooting

    X-LAB Control Module or error messages on the Processing Report from the X-SERIES DataTrak Software . Follow instructions under User Action for the indicated error or message . In the event that liquids enter the X-LAB Control Module, contact Corning Scientific Support for assistance .
  • Page 51 Action by User Place the same loaded Corning® X-LAB® Disposable Depletion valve The RBC pinch valve has failed to open when Cartridge on a new Corning X-LAB Control Module open failed directed . and repeat the run. Contact Corning Scientific Support for assistance .
  • Page 52 • 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-LAB® 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 53: Technical Support

    11.0 Technical Support All Corning® X-LAB® Systems purchased will be supplied with a copy of the X-LAB 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 54 Corning® X-LAB® 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 55 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: • Windows® 7 or 10 Operating System •...
  • Page 56 230V, 50 Hz 75-004-505 75-004-520 *Includes a NEMA Plug 6-15 The Corning X-LAB Disposable Cartridges use a single rotor and bucket set . One of each of these parts numbers is required for centrifuge operation: Thermo Scientific Cat. No. Description...
  • Page 57 100 - 120V, 60 Hz 5675 200 - 240V, 50 Hz 5670 The Corning X-LAB System Disposable Cartridges use a single rotor and bucket set . One of each of these parts numbers is required for centrifuge operation: Hettich Cat. No.

  • Page 58: 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:

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