Related Manuals for BioLife ThawSTAR CB
Summary of Contents for BioLife ThawSTAR CB
- Page 1 ThawSTAR ® User Manual BioLifeSolutions.com | 3303 Monte Villa Parkway, Suite 310, Bothell, WA 98021 P/N: 200-1251-04 1.866.424.6543 | Fax: 1.425.402.1433 | ThawTechSupport@BioLifeSolutions.com IG-AST-220302_R04...
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Page 2: Table Of Contents
Table of Contents 1. General Information ......................4 1 General Information ........................ 4 1.2 Important Safety Information ....................4 1.3 On-Product Safety Symbols ....................6 1.4 System Components, Terminology, and Interface Conventions ........6 2. Installation ..........................10 2.1 Unboxing ..........................10 2.2 Plug In / Power Up ....................... - Page 3 4.2.3.2 Importing Data ....................38 4.2.3.3 Validation Sequence ..................... 39 4.2.3.4 Connection of ThawSTAR® CB via Ethernet ............... 40 5. Troubleshooting ........................44 5.1 Power Failure — Emergency Cryobag Removal ..............44 5.2 Thaw Results — Errors and Failures .................. 46 5.2.1 Emergency Release Error ..................
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Page 4: General Information
1. General Information 1 General Information The ThawSTAR CB is intended to be used in research labs, manufacturing suites, or other laboratory settings. ® The ThawSTAR CB provides a standardized thawing process for cryobags containing cryopreserved biologic ® materials. It is designed to only accept cryobags that have been frozen in a flat orientation such that both major surfaces of the bag are planar and parallel as possible. - Page 5 Handle the ThawSTAR CB with care. If the equipment is used in a manner not specified by ® BioLife Solutions, protections provided by the equipment may be impaired. Never store a ThawSTAR CB on its side or upside down •...
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Page 6: On-Product Safety Symbols
GENERAL INFO 1.3 On-Product Safety Symbols SHOCK WARNING Always disconnect power to the equipment and unplug before performing any service or maintenance. Contact with high voltage could result in injury or death. SHOCK CAUTION Do not operate without proper electrical ground. REFER TO INSTRUCTION MANUAL Read the instruction manual before using the ThawSTAR CB system. - Page 7 GENERAL INFO Ethernet Port USB Port Power Cable Port Power Switch Figure B: Back of the ThawSTAR ® Fan Vent Emergency Release The plastic cover can be removed in the event of an emergency (e.g., power loss), to manually disengage the internal clamping mechanism and force open the drawer so that the user may remove the cryobag from the ThawSTAR CB without completing the thaw.
- Page 8 (e.g., target temperatures and times at specific points in the thaw event) is referred to as a profile. The ThawSTAR ® CB software comes pre-loaded with default thaw profiles that have been developed for a variety of specific cryobag sizes and fill volumes. BioLife can also create custom profiles optimized to preserve the viability of specific cell types. Archive A list or history of thaw events that have been previously performed on the system.
- Page 9 CB is powered on. The Archive button gives you access to the record of previously completed thaw events. The About button brings you to a screen listing contact information for BioLife Solutions Customer Support and system information. Customer Support: 1-866-424-6543 Supplies: www.biolifesolutions.com/ThawSTAR Technical Inquiries: ThawTechSupport@ BioLifeSolutions.com...
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Page 10: Installation
Use the Power Switch on the back of the system to turn on the ThawSTAR CB. The ® BioLife Solutions logo behind the dead- front glass will illuminate and the Display will activate and run through a boot sequence. The ThawSTAR CB is now ready for use. -
Page 11: Operator Functions
3. Operator Functions CAUTION Cryobags must be frozen in cassettes (typically aluminum) in a flat orientation so that the liquid forms a uniform wafer upon solidification. Failure to freeze the cryobags flat inside a cassette will severely impact the performance of the ThawSTAR ®... - Page 12 Overwraps or other secondary containment bags on cryobags must be removed prior to thawing. If a cryobag comes in an overwrap it will need to be removed before the cryobag can be inserted into the BioLife Solutions Barrier Bag. CAUTION Cryobag label flaps (reference CS-50) need to be oriented facing upwards.
- Page 13 OPERATOR FUNCTIONS Using protective gloves, remove the cryobag from any transportation or storage containers and freezing cassette. Insert the cryobag into the correctly sized Barrier Bag. It is preferable that the underside of the frozen cryobag remains the underside that contacts the Drawer of the ThawSTAR ®...
- Page 14 OPERATOR FUNCTIONS A confirmation screen will appear. Select Exit to end the thaw preparation process. If you wish to continue with the thaw preparation process, select Resume. CAUTION Ensure the drawer is clear to close with the Barrier Bag’s sealing side placed under the top cover and the registration pins properly aligned.
- Page 15 OPERATOR FUNCTIONS At the end of the thaw event, the Drawer will automatically open and the system will display either a Thaw Successful or Thaw Failure screen. See Section 3.2 for Thaw Results. Keep hands and other objects clear of the moving Drawer.
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Page 16: Thaw Results
OPERATOR FUNCTIONS 3.2 Thaw Results At the end of a thaw event, the Drawer will automatically open and the ThawSTAR CB will display either a Thaw ® Successful or Thaw Failure message. Successful thaw results are automatically saved to the system Archive. -
Page 17: Aborting A Thaw
OPERATOR FUNCTIONS 3.3 Aborting a Thaw Once a thaw has been started, it is possible to abort the process by double-tapping the Abort Thaw button. On the Abort Thaw screen, press and hold the two Stop Thaw buttons simultaneously. Once the thaw has been aborted, the Drawer will automatically open. - Page 18 OPERATOR FUNCTIONS Selecting the Dismiss button on the resulting Thaw Failure screen will take you back to the Home screen. You are ready to start another thaw event.
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Page 19: Administrator Passwords And Functions
4. Administrator Passwords and Functions Administrators are able to access password-protected functions related to the system Archive, Users, and Thaw Profiles. Administrator functions may include the ability to edit and add new Users, Thaw Profiles, and Archives; and export/import data from a USB drive, and delete. NOTE: The default password is “password”... -
Page 20: Viewing Archive Entries
ADMINISTRATOR PASSWORDS AND FUNCTIONS 4.1.1 Viewing Archive Entries Starting from the Thaw Archive screen (see Section 4.1), select the caret to the right of the specific thaw event entry you would like to view. You will see additional information for that specific thaw event. -
Page 21: Exporting Archive Entries
ADMINISTRATOR PASSWORDS AND FUNCTIONS 4.1.2 Exporting Archive Entries When viewing a single archive entry, it is possible to export that entry to a USB drive (no option to delete upon export in single entry archive review/export mode). Batch archive exports allow deletion via the Utilities screen (see Section 4.2.3). -
Page 22: Settings
ADMINISTRATOR PASSWORDS AND FUNCTIONS 4.2 Settings System User and Thaw Profile management functions are accessed via the Settings menu button. From the Home screen, select Settings. Enter Administrator’s Username and Password using the pop-up keyboard. Select Confirm to advance to the next screen. Use the Settings screen to access Thaw Profiles, Users, and Utilities. -
Page 23: Users
ADMINISTRATOR PASSWORDS AND FUNCTIONS 4.2.1 Users On the Settings screen (see Section 4.2), select Users. 4.2.1.1 Creating Users On the Users screen, select Add New User. Use the pop-up keyboard to enter the new Username and User identity on the Create New User screen. - Page 24 ADMINISTRATOR PASSWORDS AND FUNCTIONS Determine whether the new User should have Operator- or Administrator-level permissions. Select the corresponding radio button. If “Administrator” is selected, you will be prompted to enter a password for the new User. Select Save to add the New User to the system. You should see the newly created User listed on the Users screen.
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Page 25: Editing Users
ADMINISTRATOR PASSWORDS AND FUNCTIONS 4.2.1.2 Editing Users On the Users screen, select the caret to the right of the User you wish to edit. Edit the User’s password using the pop-up keyboard. Permissions can be edited if desired. Select Save to save your changes and return to the Users screen. - Page 26 ADMINISTRATOR PASSWORDS AND FUNCTIONS Check the box next to the User you wish to delete. Select Delete to confirm. The list of Users on the Users screen should reflect the deletion.
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Page 27: Exporting Users
ADMINISTRATOR PASSWORDS AND FUNCTIONS 4.2.1.4 Exporting Users Users can either be Deleted or Exported (there is no option presented to delete after Export as with Thaw Archives). There is a secondary means by which Users and other data from the machine can be exported and deleted (reset to factory defaults) by using the Utilities Screen (see Section 4.2.3). -
Page 28: Importing Users
ADMINISTRATOR PASSWORDS AND FUNCTIONS An “Export Complete” or “Export Failed” screen will appear. Selecting Ok on either screen will return you to the previous Users screen. NOTE: If you receive the “Export Failed” screen, check to see if your USB drive is corrupted. You may need to reformat the USB drive. -
Page 29: Thaw Profiles
CB is shipped with a default set of Thaw Profiles. Additional Thaw Profiles ® can be optimized for your specific biomaterial by a BioLife Solutions technical expert, and added by a local Admin User to the Thaw Profile library. On the Settings screen (see Section 4.2), select... -
Page 30: Viewing Thaw Profiles
ADMINISTRATOR PASSWORDS AND FUNCTIONS 4.2.2.1 Viewing Thaw Profiles On the Thaw Profiles screen, select the caret to the right of the individual Thaw Profile that you would like to view. Information regarding individual Thaw Profiles is presented on four tabs. The General tab lists the biologic name and bag size. -
Page 31: Deleting Thaw Profiles
ADMINISTRATOR PASSWORDS AND FUNCTIONS The Sensor Qualification tab displays information regarding the ThawSTAR CB’s enabled sensors. ® The Parameters tab displays other thaw settings. 4.2.2.2 Deleting Thaw Profiles On the Settings screen (see Section 4.2), select Thaw Profiles. Press the Manage button. - Page 32 ADMINISTRATOR PASSWORDS AND FUNCTIONS Check the box next to the Thaw Profile(s) you wish to delete. Select Delete to confirm. The list of Thaw Profiles should reflect the deletion. Select Back to return to the Settings screen.
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Page 33: Exporting Thaw Profiles
ADMINISTRATOR PASSWORDS AND FUNCTIONS 4.2.2.3 Exporting Thaw Profiles When exporting Thaw Profiles from the Thaw Profiles screen, there is no option to delete after exporting. The only way to delete Thaw Profiles after exporting is via the Utilities screen (see Section 4.2.3). On the Thaw Profiles screen, select Manage. -
Page 34: Importing Thaw Profiles
ADMINISTRATOR PASSWORDS AND FUNCTIONS An “Export Complete” or “Export Failed” screen will appear. Selecting Ok on either screen will return you to the previous Thaw Profiles screen. If you receive the “Export Failed” screen, check to see if your USB drive is corrupted. You may need to reformat the USB drive. -
Page 35: Utilities
ADMINISTRATOR PASSWORDS AND FUNCTIONS Check the box next to Profiles. Insert the USB drive into the USB Port. See Section 4.2.3.2 Importing Data. 4.2.3 Utilities The Utilities Section of the ThawSTAR CB enables Admins to Batch Export and Import Data, Reset the machine to ®... - Page 36 ADMINISTRATOR PASSWORDS AND FUNCTIONS From the Export screen, it is possible to export Users, Thaw Profiles, or the system Archives. It is also possible to delete or keep the files on the system after export. We will illustrate the process using Archives. The steps are the same when exporting Users and Thaw Profiles from this screen.
- Page 37 ADMINISTRATOR PASSWORDS AND FUNCTIONS Insert a USB drive into the USB Port. Select Export. If Delete Archives after export was selected, you will be asked to confirm deletion of the data from the system. If you select Cancel you will return to previous Export screen, and the data will remain on the system.
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Page 38: Importing Data
ADMINISTRATOR PASSWORDS AND FUNCTIONS 4.2.3.2 Importing Data On the Utilities screen, select Import Data. From the Import screen, it is possible to import Users, Thaw Profiles, or Archives. We will illustrate the process using Thaw Profiles. The steps are the same when importing Users and Archives from this screen. -
Page 39: Validation Sequence
ADMINISTRATOR PASSWORDS AND FUNCTIONS Select the correct file from the drop-down menu of filenames. Select Import to download the file from the USB drive. If Delete Archives after export was selected, you will be asked to confirm deletion of the data from the system. -
Page 40: Connection Of Thawstar® Cb Via Ethernet
Admin credentials. Data Mode. Press the “Ok” button when the dialog box appears on the ThawSTAR CB to set up Ethernet Data Mode at the Communications page (Step 5). Sign in when prompted The Communications page can also be with Admin credentials. - Page 41 Once the desired settings are inputted, press Save and Continue. On the Data Export Page, the ThawSTAR CB serial number (found in the “About” Tab and on the rear of the unit) is the Username. Note the lower case “cb”...
- Page 42 CONNECTION VIA ETHERNET Move the slider to the right to Enable Ethernet Export. If laboratory and IT personnel require all local archives of data to be removed from the instrument, click the Remove Local Archives Checkbox Warning: no data will be stored for retrieval on this unit when “Remove Local Archives”...
- Page 43 CONNECTION VIA ETHERNET If setting up a file share on a Windows computer attached to the local network, the destination file path for the ThawSTAR CB can be found at \\192.168.0.123\edm in the example in the image to the left.
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Page 44: Troubleshooting
5. Troubleshooting 5.1 Power Failure — Emergency Cryobag Removal In case of unexpected power loss, the ThawSTAR ® has been equipped with an Emergency Release Lever to release the internal clamping mechanism and allow the drawer to be manually opened. To retrieve the cryobag in the event of power loss, follow the procedure outlined below: Turn off the power on the rear of the unit and remove... - Page 45 TROUBLESHOOTING Gently pull on the Emergency Release Lever away from the rear face of the ThawSTAR ® Gently pull open the Drawer by grabbing it from the underside. Remove the cryobag from the Drawer. CAUTION Do not turn on the ThawSTAR CB with the Emergency Release Lever rotated away from the ®...
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Page 46: Thaw Results - Errors And Failures
TROUBLESHOOTING 5.2 Thaw Results — Errors and Failures 5.2.1 Emergency Release Error Pulling the Emergency Release Lever during a thaw event causes this error. Push the Emergency Release Lever in towards the rear wall and replace the cover before restarting a new Thaw. For detailed corrective action see Section 5.3.1. -
Page 47: Sensor Qualification Error Prevention
TROUBLESHOOTING 5.2.3 Sensor Qualification Error Prevention Sensor qualifications errors are typically caused by lack of contact between bags and sensors, and can be addressed by modifications to the freezing process. To improve contact between bags and sensors the following options are recommended to be applied to the freezing process: Press OK to return to the main menu. Eliminate gas pockets within the cryobag prior to sealing. -
Page 48: User-Correctable Errors
TROUBLESHOOTING 5.3 User-correctable Errors 5.3.1 Emergency Release Error This error is caused by pulling the Emergency Release Lever while the machine is powered. The first step of the Emergency Procedure (see Section 5.1 or Quick Start Guide) is to unplug the machine. To correct this error the User should replace the lever to its original position. -
Page 49: Technical Errors
TROUBLESHOOTING 5.4 Technical Errors These are errors that require technical support. For service or repair support please call BioLife Solutions at 1-866-424-6543 or ThawTechSupport@BioLifeSolutions.com 5.4.1 Clamp Timeout This error is serious and must be corrected by a BioLife-authorized technician. For service or repair support please call BioLife Solutions at 1-866-424-6543. -
Page 50: Restore Defaults
TROUBLESHOOTING 5.5 Restore Defaults Restoring Defaults recreates the default Admin User and default Thaw Profiles. On the Settings screen (see Section 4.2), select Utilities. On the Utilities screen, select Restore Defaults. Confirm Restore Defaults. -
Page 51: Factory Reset
TROUBLESHOOTING 5.6 Factory Reset Factory reset will remove all Thaw Profiles and Users and recreate the default Admin User and default Thaw Profiles. On the Settings screen (see Section 4.2), select Utilities. On the Utilities screen, select Factory Reset. Confirm Reset Data. -
Page 52: Cleaning
No regular mechanical maintenance is necessary or advised for the ThawSTAR® CB. No customer-serviceable parts are contained within the system. For service or repair support please call BioLife Solutions Corporation at 1-866-424-6543. Clean exterior or drawer surfaces only with a soft, non-abrasive laboratory wipe moistened with a 70 percent isopropyl alcohol solution followed by a laboratory wipe moistened with pure water, then wipe dry. -
Page 53: Cryobag Dimensions
PRODUCT SPECIFICATIONS 7.3 Cryobag Dimensions Bag external dimensions Unit and features Length 10.5 inches Width 3.75 inches Thickness 0.375 0.75 inches Fill volume Starting temperature -196 °C Bag Manufacturers OriGen, Miltenyi, Charter Bag size ranges Nominal sizes 25ml through 1000ml Length 6.35 26.67... - Page 55 BioLifeSolutions.com | 3303 Monte Villa Parkway, Suite 310, Bothell, WA 98021 IG-AST-220302_R04 1.866.424.6543 | Fax: 1.425.402.1433 | ThawTechSupport@BioLifeSolutions.com...
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