Related Manuals for Thermo Scientific Gibco CTS Rotea
Summary of Contents for Thermo Scientific Gibco CTS Rotea
- Page 1 ™ ™ Rotea Counterflow Centrifugation System USER GUIDE Catalog Number A44769 Publication Number MAN0018908 Revision A.0 For Research Use or Manufacturing of Cell, Gene, or Tissue- Based Products.
- Page 2 Life Technologies Holdings Pte Ltd | Block 33 | Marsiling Industrial Estate Road 3 | #07-06, Singapore 739256 For descriptions of symbols on product labels or product documents, go to thermofisher.com/symbols-definition. The information in this guide is subject to change without notice. DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC.
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Page 3: Table Of Contents
Contents ■ CHAPTER 1 Product information ..........7 Product description . - Page 4 Contents ■ CHAPTER 3 Basic instrument operation ........41 Open the door .
- Page 5 Contents MES batch history data ........... . . 94 Alarm recovery tools .
- Page 6 Contents ■ APPENDIX A Safety ............. . 121 Symbols on this instrument .
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Page 7: Chapter 1 Product Information
Product information IMPORTANT! Before using this product, read and understand the information in the “Safety” appendix in this document. Product description ™ ™ The CTS Rotea Counterflow Centrifugation System is an automated, closed-flow benchtop instrument that can perform a wide variety of cell processing steps across different cell types. ™... -
Page 8: System Overview
Chapter 1 Product information System overview System overview Instrument description Figure 1 Instrument – Front View Instrument Door Optical Density Sensor & Pressure Sensor (P1) Pinch Valves (J & K) Peristaltic Pump Kit Location Button Pump Clamp Arm 2D Barcode Reader Pinch Valve (H) CFC Chamber Detector Kit Location Button &... - Page 9 Chapter 1 Product information System overview 1 1 1 1 Figure 2 Instrument – Rear View Power Switch Mains Connector CAN bus (2 off) Ethernet (RJ-45) USB-C Bag Hooks Hanger Post Hanger Post Adjustment ™ Rotea ™ Counterflow Centrifugation System User Guide...
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Page 10: Instrument Dimensions
Chapter 1 Product information System overview Instrument dimensions Working space ™ The Rotea instrument is designed for bench top use and requires a working space of approximately Height: 30” (76 cm), Width: 25” (63.5 cm), Depth: 20” (50.8 cm). Note: The 2‑in‑1 laptop is connected via a USB-C cable and hence can be located in a range of positions. -
Page 11: Instrument Properties
Chapter 1 Product information System overview Instrument properties Category Property Value Electrical Supply voltage 100–240 V AC ±10%, 50/60 Hz Phases Single Maximum Rated Input Current Fuses 2 x 5 A Sound level Maximum sound level 70 dBA (measured 1 m from instrument) Typical sound level 65 dBA (measured 1 m from instrument) Environmental ranges... - Page 12 Chapter 1 Product information System overview (continued) Category Property Value Minimum concentrate recovery 5 mL (subject to protocol optimization) volume Centrifuge chamber volume 10 mL chamber containing up to 4 × 10 cells (cell type and operating parameters dependent). Note: Centrifuge chamber can be filled multiple times to process larger batches.
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Page 13: Push Button Controls
Chapter 1 Product information System overview Push button controls ™ Once a protocol has been loaded and confirmed, the Rotea instrument can be operated almost entirely from the push buttons on the front of the instrument. Figure 3 Instrument push button controls Light STOP START/PAUSE... -
Page 14: Cts ™ Rotea ™ Single-Use Kit Schematic
Chapter 1 Product information System overview ™ Rotea ™ Single-Use Kit schematic ™ ™ The CTS Rotea Single-Use Kit enables users to configure kits to suit different protocols by adding input and output vessels. Unused fluid lines are simply left sealed off. ™... -
Page 15: Wetted Components
Chapter 1 Product information System overview Wetted components ™ ™ The materials used in the manufacturing of the CTS Rotea Single-Use Kit have been chosen for their biological and chemical compatibility. Component Description Material Pump tubing Pump tube Bioprene Kit tubing 0.160”... -
Page 16: Chapter 2 Installation And Setup
Installation and setup Packaging contents ™ • Rotea instrument • Hanger posts (2 off) • Mains plug IEC cables (USA/EUROPE/AUSTRALIA) • Pre-fitted mains fuses (2 x 5A) • USB-C (male) to USB-C (female) ™ • Dell 2‑in‑1 laptop tablet (this will be in a separate carton) Instrument installation •... - Page 17 Chapter 2 Installation and setup Instrument installation Note: Suitable means of protective earthing are provided for this device Figure 5 Back view of instrument Mains IEC connector USB-C port 1. Connect mains IEC connector. 2. Plug mains into power GPO 3.
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Page 18: Power Instrument "On
Chapter 2 Installation and setup Power instrument “On” Power instrument “On” 1. Switch on using the mains IEC switch at the rear of the instrument. 2. The instrument button lights will sequence as the instrument powers up. If the door is closed, the instrument will automatically check if a Single-Use Kit is installed. -
Page 19: Power Instrument "Off
Chapter 2 Installation and setup Power instrument “Off” Power instrument “Off” Switch off the instrument using the mains IEC switch or mains power. CAUTION! There is no automatic recovery procedure. If a loss of power event has occurred see “Restart after shut down” on page 117. -
Page 20: Installation
Chapter 2 Installation and setup Installation Installation ™ ™ ™ ™ The Dell 2‑in‑1 laptop will be pre-installed with Windows OS. The latest CTS Rotea Graphical User ™ Interface (GUI) software will need to be installed onto the Dell 2‑in‑1 laptop provided. New releases of ™... - Page 21 Chapter 2 Installation and setup Installation 2. Run the Rotea-X.X.X.exe installer. Click Install. The application will be installed in C:\Program Files (x86)\Rotea\. 3. Click Close to finish the app installation. 4. Power on the Rotea ™ instrument (with the switch on the back) and plug it into the laptop. ™...
- Page 22 Chapter 2 Installation and setup Installation 5. The next step is to update Windows ™ software. Make sure the laptop is connected to the local wifi network. This can be done by opening the start menu and searching for Check for updates. 6.
- Page 23 Chapter 2 Installation and setup Installation 7. Check if Windows Update installed the required USB device drivers. Right click on This PC on the desktop and open Manage. 8. Ensure the USB devices are detected correctly. Check that the devices highlighted in figure can be seen: •...
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Page 24: First Time Setup
Chapter 2 Installation and setup First time setup First time setup 1. Push the power button on the laptop to start Windows ™ software. 2. Run the Rotea ™ application from the desktop or start menu. The application has a single admin user with Username: admin, Password: admin on a fresh installation. - Page 25 Chapter 2 Installation and setup First time setup 3. The main navigation menu in the top right corner is used to get to all areas of the applications. 4. Click the Settings in the navigation menu to set the instrument name. Edit the instrument name if required.
- Page 26 Chapter 2 Installation and setup First time setup 5. Click User Management in the navigation menu to change the admin username/password. This page shows all the users configured for in the application. Click the admin user to change the account details. New users can be added with the + button. 6.
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Page 27: Download Protocols
Chapter 2 Installation and setup Download protocols Download protocols Create protocols Protocols comprise a series of individual steps that are to be perfomed by the instrument. Triggers are used to define when the instrument will move to the next step. A range of existing protocols can be downloaded from the Thermo Fisher Scientific portal. - Page 28 Chapter 2 Installation and setup Download protocols 2. Click Browse or Select a Protocol to browse for a protocol stored locally or on any connected devices. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 29 Chapter 2 Installation and setup Download protocols 3. Double click the required protocol to display the filename in the Protocol File text box. 4. Click on Select Protocol. Note: If an invalid protocol is selected, a warning box will be displayed. ™...
- Page 30 Chapter 2 Installation and setup Download protocols ™ Rotea ™ Counterflow Centrifugation System User Guide...
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Page 31: Rotea ™ Gui Dashboard
Chapter 2 Installation and setup Download protocols Rotea ™ GUI dashboard ™ ™ The Rotea GUI dashboard is the primary means of navigation around the Rotea GUI and operation ™ of the Rotea instrument. It can be operated using the laptop touch screen only or with the keyboard attached. -
Page 32: User Management
Chapter 2 Installation and setup Download protocols User Management 1. Select User Management from the dropdown menu. ™ Rotea ™ Counterflow Centrifugation System User Guide... - Page 33 Chapter 2 Installation and setup Download protocols 2. Click on the + icon to add a new user. 3. Type in new Username and Password. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 34 Chapter 2 Installation and setup Download protocols 4. Confirm new password. 5. Select Access Level from dropdown list. 6. Select default folder for saving protocols. 7. Click Add Account to save new user settings. 8. Edit user account details including setting Access Level. 9.
- Page 35 Chapter 2 Installation and setup Download protocols 10. Select to delete a user. 11. Click Confirm or Cancel. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 36 Chapter 2 Installation and setup Download protocols 12. Users without admin rights can edit their profile by selecting Profile from the dropdown menu. 13. Edit user profile fields. 14. Click Save or Cancel. ™ Rotea ™ Counterflow Centrifugation System User Guide...
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Page 37: Uninstall
Chapter 2 Installation and setup Uninstall Uninstall 1. Open the Add or remove programs utility by searching for it in the start menu. ™ Rotea ™ Counterflow Centrifugation System User Guide... -
Page 38: Logging
Chapter 2 Installation and setup Logging 2. Search and remove the Rotea ™ application. 3. Wait for the uninstall to complete and the Rotea ™ application will be removed. The user database and log files will not be deleted when the application is uninstalled. If the user wants to permanently delete them, they need to be deleted manually by removing the C:\ProgramData\Rotea directory. - Page 39 Chapter 2 Installation and setup Logging You can also add notes to the run log. • Click Add Log Comment in the dropdown menu during a protocol run. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 40 Chapter 2 Installation and setup Logging • Write comment in the comment box and click Add Comment. ™ Rotea ™ Counterflow Centrifugation System User Guide...
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Page 41: Chapter 3 Basic Instrument Operation
Basic instrument operation Open the door The instrument door is automatically locked by the instrument and can only be opened when the: • Instrument is powered up • Blue door unlock button is illuminated • Instrument is not currently running a protocol •... - Page 42 Chapter 3 Basic instrument operation Open the door Note: An emergency maintenance access method can be used to open the door should this be required e.g. in the case of power loss – (See “Open the door without power” on page 111).
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Page 43: Kit Preparation, Loading And Removal
Chapter 3 Basic instrument operation Kit preparation, loading and removal Kit preparation, loading and removal Kit configuration ™ Once a protocol has been selected to run on the instrument, the Kit View on the Rotea ™ ™ dashboard will display a schematic of the CTS Rotea Single-Use Kit with bag connections. - Page 44 Chapter 3 Basic instrument operation Kit preparation, loading and removal ™ Figure 7 Rotea GUI showing Kit View ™ CAUTION! The Single-Use Kit has been designed exclusively for use with the Rotea instrument and includes several features to enable fast, error-free loading by the user. It is the responsibility of the user to ensure correct assembly and loading of the Single-Use Kit prior to initiating an instrument protocol.
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Page 45: Pre-Assembly Of Processing Kit
Chapter 3 Basic instrument operation Kit preparation, loading and removal Pre-assembly of processing kit 1. Peel open the sealed pouch and remove the Single-Use Kit. 2. Release the CFC Chamber from the Carrier Frame if still retained. ™ Rotea ™ Counterflow Centrifugation System User Guide... -
Page 46: Connecting Vessels, Bags And Reagents
Chapter 3 Basic instrument operation Kit preparation, loading and removal Connecting vessels, bags and reagents ™ The instrument has been specifically designed for single use, functionally closed processing. The CTS ™ Rotea Single-Use Kit uses DEHP-Free PVC 0.160” OD tubing to enable sterile welding to compatible bags using devices that service the blood banking industry such as the TSCD II Sterile Tubing Welder (TerumoBCT). -
Page 47: Bubble Trap
Chapter 3 Basic instrument operation Kit preparation, loading and removal Bubble Trap ™ ™ To manage air in the system, the CTS Rotea Single-Use Kit includes a small bubble trap with a capacity of approximately 5 mL. Figure 9 CTS ™... -
Page 48: Kit Installation
Chapter 3 Basic instrument operation Kit preparation, loading and removal Kit installation 1. Ensure door is open and any previous Single-Use Kit has been removed. 2. Hang input / output bags on hanger hooks. Note: The product input bag can be suspended using one of the side cut-outs on the bag to help ensure that all product drains from the bag. - Page 49 Chapter 3 Basic instrument operation Kit preparation, loading and removal 3. Place the Carrier Frame over the two Single-Use Kit location buttons on the instrument. 4. Install the CFC Chamber into the CFC Chamber Carrier. a. Load CFC Chamber into the CFC Chamber Carrier. b.
- Page 50 Chapter 3 Basic instrument operation Kit preparation, loading and removal c. Slide CFC Chamber away from axis of rotation until the latch clicks. 5. Insert tubes A, B, C, D, E, F & G into the corresponding slot in the Bubble Detector Strip and push downwards with fingers to fully engage each tube in the slot.
- Page 51 Chapter 3 Basic instrument operation Kit preparation, loading and removal 6. Stretch the pump tubing around the Peristaltic Pump rollers and insert the Tube Retainer into the Sensor Block to hold it in place. Pump tube barbed connector correctly placed in the Sensor Block. ™...
- Page 52 Chapter 3 Basic instrument operation Kit preparation, loading and removal 7. Insert tubing in Sensor Block channel. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 53 Chapter 3 Basic instrument operation Kit preparation, loading and removal Correct: Pressure Sensor tubing in Incorrect: Pressure Sensor tubing out CAUTION! The instrument cannot detect if the pump tubing or Tube Retainer have been correctly positioned. Check prior to closing the door. CAUTION! The tube will sit slightly proud of the channel in the region of the Pressure Sensor so that the tube is compressed into the required shape when the door is closed.
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Page 54: Initiate A Protocol
Chapter 3 Basic instrument operation Kit preparation, loading and removal Initiate a protocol 1. Click Initiate to commence running the protocol. ™ Rotea ™ Counterflow Centrifugation System User Guide... - Page 55 Chapter 3 Basic instrument operation Kit preparation, loading and removal 2. Close the door. Note: Soft close hinges prevent the door from dropping suddenly. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 56 Chapter 3 Basic instrument operation Kit preparation, loading and removal 3. Push the door downwards to compress the Single-Use Kit tubing onto Pressor Sensors and other control features. 4. (auto): Closing the door initiates the following automatic system checks. The status of each system ™...
- Page 57 Chapter 3 Basic instrument operation Kit preparation, loading and removal 5. Errors detected during the automatic system check are identified with a and will require the user to identify and rectify the source of the error. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 58 Chapter 3 Basic instrument operation Kit preparation, loading and removal 6. Manually confirm that the Single-Use Kit configuration matches the image and that manual clamps have been opened. 7. Click Confirm to continue. CAUTION! Manual clamps are provided for use on input and output lines on the Single- Use Kit to prevent fluid movement until the instrument Pinch Valves are engaged.
- Page 59 Chapter 3 Basic instrument operation Kit preparation, loading and removal 9. Click Confirm or Cancel. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 60 Chapter 3 Basic instrument operation Kit preparation, loading and removal 10. The protocol is automatically sent to the instrument and the Rotea ™ GUI dashboard is displayed for the new protocol. ™ Rotea ™ Counterflow Centrifugation System User Guide...
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Page 61: Run A Protocol
Chapter 3 Basic instrument operation Run a protocol Run a protocol ™ Rotea GUI navigation and instrument operation 1. Press the Start button on the instrument to start the protocol. 2. Change the Rotea ™ GUI dashboard view as required by clicking on the tabs. ™... - Page 62 Chapter 3 Basic instrument operation Run a protocol 3. The live video will automatically turn on when the centrifuge speed exceeds 500 × g. The live video can be manually turned on at any operating speed by clicking on the Turn on video toggle. ™...
- Page 63 Chapter 3 Basic instrument operation Run a protocol 4. The instrument will automatically progress through each step in the protocol until the protocol is complete, pre-defined user intervention is required or an error occurs. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 64 Chapter 3 Basic instrument operation Run a protocol 5. Depending on user access rights, the user can make in-process adjustments to the following parameters using the control buttons: • Reset Step Time Remaining • Increase/reduce Pump flow rate • Increase/reduce Centrifuge g-force 6.
- Page 65 Chapter 3 Basic instrument operation Run a protocol 7. Return to the dashboard by clicking on or using the dropdown menu. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 66 Chapter 3 Basic instrument operation Run a protocol Value volumes and pressure sensor values When in Kit View, click on the Details to display the current net volume that has passed through each valve and the current pressure of P1 and P2. When the valve volume is positive, more liquid has been pumped out through a valve than has been pumped in, increasing the volume in the attached bag.
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Page 67: Error Messages
Chapter 3 Basic instrument operation Run a protocol Note: · The valve volumes are not the same as the volume that has entered or left a bag. In the example shown, the input bag (cells in culture) is a dual port bag connected to both valve D and G. To calculate the volume change in or out of the input bag, add the valve volumes for valves D and G e.g. - Page 68 Chapter 3 Basic instrument operation Run a protocol (continued) Alarm or Critical Warning Instrument response GUI message message alarm — Trigger instrument stop state Centrifuge error Centrifuge error Protocol run has stopped. Press the stop button on the insturment, close manual clamps and open and close the instrument door to reset.
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Page 69: Kit Removal
Chapter 3 Basic instrument operation Kit removal (continued) Alarm or Critical Warning Instrument response GUI message message alarm — Trigger instrument stop state Over-pressure Blockage detected condition Protocol run has stopped. Ensure manual clamps are open and bags are connected correctly. - Page 70 Chapter 3 Basic instrument operation Kit removal 2. Open the door and raise until past vertical. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 71 Chapter 3 Basic instrument operation Kit removal 3. Remove the CFC Chamber from the CFC Chamber Carrier by lifting the lever and rotating the CFC Chamber back towards the latch. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 72 Chapter 3 Basic instrument operation Kit removal 4. Lift CFC Chamber clear of the Centrifuge Carrier. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 73 Chapter 3 Basic instrument operation Kit removal 5. Remove the tubing from the Sensor Block and Peristaltic Pump. ™ Rotea ™ Counterflow Centrifugation System User Guide...
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Page 74: Aseptic Disconnection Of The Kit Components
Chapter 3 Basic instrument operation Aseptic disconnection of the kit components 6. Gently raise the Carrier Frame drawing out the tubes from the Bubble Sensor. Aseptic disconnection of the kit components If not done prior to Single-Use Kit removal from the instrument: •... -
Page 75: System Settings
Chapter 3 Basic instrument operation System settings System settings Instrument firmware 1. Select Settings from the drop down menu. ™ Rotea ™ Counterflow Centrifugation System User Guide... - Page 76 Chapter 3 Basic instrument operation System settings 2. Click on the Firmware tab. 3. Select the latest firmware. 4. Click Update. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 77 Chapter 3 Basic instrument operation System settings 5. The selected firmware will be automatically updated. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 78 Chapter 3 Basic instrument operation System settings 6. The system will automatically reboot. 7. Once firmware has updated successfully, click Done. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 79 Chapter 3 Basic instrument operation System settings 8. If firmware has not been updated click Done and restart the firmware update. ™ Rotea ™ Counterflow Centrifugation System User Guide...
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Page 80: Opc-Ua
Chapter 3 Basic instrument operation System settings OPC-UA An Open Platform Communications - United Architecture (OPC-UA) interface is provided that enables ™ admin users to connect Rotea instrument to a Supervisory Control and Data Acquisition (SCADA) system to send protocols, start a protocol and monitor run progress, see Chapter 4, “OPC-UA interface”. -
Page 81: Settings
Chapter 3 Basic instrument operation System settings Settings Admin users have the ability to update the instrument settings via the Rotea Settings tab. ™ Rotea ™ Counterflow Centrifugation System User Guide... -
Page 82: Licenses
Chapter 3 Basic instrument operation System settings Licenses All relevant software licenses are listed in the Licenses tab. The detail for each license can be displayed by clicking on the v arrows. ™ Rotea ™ Counterflow Centrifugation System User Guide... -
Page 83: Calibration
Chapter 3 Basic instrument operation Calibration Calibration 1. Select Calibration ( ) from the drop down menu. ™ Rotea ™ Counterflow Centrifugation System User Guide... - Page 84 Chapter 3 Basic instrument operation Calibration 2. Input Target Volume. 3. Input Actual Volume from calibration test run. 4. Select Kit Type from the drop down list. 5. Click Calibrate. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 85 Chapter 3 Basic instrument operation Calibration 6. Click Save or Cancel. ™ Rotea ™ Counterflow Centrifugation System User Guide...
- Page 86 Chapter 3 Basic instrument operation Calibration 7. Click Done if calibration is successful. 8. If calibration was not successful, click Done and restart the calibration process. ™ Rotea ™ Counterflow Centrifugation System User Guide...
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Page 87: Chapter 4 Opc-Ua Interface
OPC-UA interface Introduction ™ ™ There are applications for the CTS Rotea Counterflow Centrifugation System where a Supervisory Control and Data Acquisition (SCADA) system will supervise the operation. This supervision will include ™ items like sending a protocol to the Rotea instrument, starting a protocol and monitoring of run progress. -
Page 88: Scope Of System
Chapter 4 OPC-UA interface Scope of system Scope of system ™ ™ Rotea Counterflow Centrifugation System is a stand alone instrument with an operational configuration comprising: • The instrument hardware • Firmware and software ™ • Dell 2‑in‑1 laptop ™ ™... -
Page 89: Protocol File
Chapter 4 OPC-UA interface MES interface Protocol file ™ • Protocol files for the Rotea instrument will be stored and transmitted in JSON format. • The JSON format provides an extensible structure to support future devices and software functions. ™ •... -
Page 90: Electronic Communications
Chapter 4 OPC-UA interface MES interface Electronic communications ™ ™ It is assumed the MES applications will be located externally to the CTS Rotea Counterflow Centrifugation System. ™ ™ Communications by any MES system to the instrument will be through the CTS Rotea GUI installed ™... -
Page 91: Mes - Commands And Reports Overview
Chapter 4 OPC-UA interface MES – Commands and reports overview MES – Commands and reports overview Figure 11 Run protocol workflow For more use cases, See “Use case sequence diagrams” on page 104. ™ Rotea ™ Counterflow Centrifugation System User Guide... -
Page 92: Enable Opc-Ua
Chapter 4 OPC-UA interface MES – Commands and reports overview Enable OPC-UA The OPC-UA interface is not enabled by default. The enable button is available to an administrator under the Settings: OPC-UA Setup tab. The OPC-UA server only supports one OPC-UA client ™... -
Page 93: Load Kit
Chapter 4 OPC-UA interface MES – Commands and reports overview The protocol checksum is an hexidecimal number with 32 characters. Example: e152abb59e4949980731c5bbf7194ffb It can be saved and compared as a string. The ProtocolState report should now report ProtocolSelected. Load kit The instrument verification process needs the instrument door to be closed and a valid kit to be detected. -
Page 94: Instrument Run Status
Chapter 4 OPC-UA interface MES – Commands and reports overview • When the instrument completes the protocol or is stopped for any other reason, the instrument state will be reported as InstrumentReady. This provides the option for the protocol to be re- started using StartatStep or other administrator actions from the InstrumentReady state. -
Page 95: Alarm Recovery Tools
Chapter 4 OPC-UA interface MES – Commands and reports overview Alarm recovery tools • Alarm reset commands; these may include active instrument reactions such as opening valves for a controlled period to release pressure. • Several options for product recovery are available through MES commands: –... -
Page 96: Opc-Ua Interface
Chapter 4 OPC-UA interface OPC-UA interface OPC-UA interface ™ Commands OPC-UA to Rotea application Table 2 OPC-UA command list Variable Type Values/Description RescanKit Boolean Force a kit rescan: • True – The instrument will rescan the kit barcode. • False – No action. •... -
Page 97: Reports Rotea ™ Application To Opc-Ua
Chapter 4 OPC-UA interface OPC-UA interface Table 2 OPC-UA command list (continued) Variable Type Values/Description SetProtocolState Enum • StopProtocol – Stop the protocol. • SendProtocolToRotea – Load the ™ protocol to the Rotea instrument. • RunProtocol – Start the protocol, same as pressing the Start button on the instrument. - Page 98 Chapter 4 OPC-UA interface OPC-UA interface Table 3 Variable set when changed (continued) Variable Type Value/Description PowerFirmwareVersion String The power board firmware version on the instrument ™ RoteaAppVersion String The Rotea application version ™ RoteaLinkUp Boolean The Rotea link state: ™...
- Page 99 Chapter 4 OPC-UA interface OPC-UA interface Table 3 Variable set when changed (continued) Variable Type Value/Description WaitingUserAck Enum Instrument has entered pause state. This will also cause the ProtocolState to transition to ProtocolPaused. The initiating event for this pause state is described: •...
- Page 100 Chapter 4 OPC-UA interface OPC-UA interface Table 3 Variable set when changed (continued) Variable Type Value/Description ProtocolEnded Enum The state indicates that the protocol has stopped and the reason that it stopped. Press the stop button or write the ProtocolState to StopProtocol will clear any Errors.
- Page 101 Chapter 4 OPC-UA interface OPC-UA interface Table 3 Variable set when changed (continued) Variable Type Value/Description ErrorRaised Enum • NoError – There are no errors • InternalError – An internal application error has occurred • FileNotFound – The SetLocalProtocolFilePath file cannot be found •...
- Page 102 Chapter 4 OPC-UA interface OPC-UA interface Table 3 Variable set when changed (continued) Variable Type Value/Description KitState Enum • NotLoaded – Kit not loaded in instrument • LoadedNotValid – Kit loaded in instrument but the Kit ID is invalid or kit type cannot be used with this protocol •...
- Page 103 Chapter 4 OPC-UA interface OPC-UA interface Table 3 Variable set when changed (continued) Variable Type Value/Description UserLevel Enum • NoUser – No user is logged in. OPC-UA has no control • ServiceUser – The service user is logged in. OPC-UA has no control •...
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Page 104: Use Case Sequence Diagrams
Chapter 4 OPC-UA interface Use case sequence diagrams Use case sequence diagrams MES run a protocol Figure 13 Run a simple protocol ™ Rotea ™ Counterflow Centrifugation System User Guide... -
Page 105: Protocol With Parametric Data
Chapter 4 OPC-UA interface Use case sequence diagrams Protocol with parametric data Figure 14 Run a simple protocol with parameters ™ Rotea ™ Counterflow Centrifugation System User Guide... -
Page 106: Mes Drives Rotea In Response To External Systems
Chapter 4 OPC-UA interface Use case sequence diagrams MES drives Rotea in response to external systems Figure 15 Pause/Play protocol while running MES drives steps within protocol Figure 16 Perform single step recovery operation from OPC-UA while running a protocol Figure 17 Perform run from step recovery operations from OPC-UA while running a protocol ™... -
Page 107: Mes Manage Error Recovery Events With Admin User
Chapter 4 OPC-UA interface Use case sequence diagrams MES manage error recovery events with admin user ™ Figure 18 Change user level to perform recovery with the Rotea ™ Rotea ™ Counterflow Centrifugation System User Guide... -
Page 108: Use List File To Load Protocol
Chapter 4 OPC-UA interface Use case sequence diagrams Use list file to load protocol ™ The look up or list file is always named OPCUAProtocolList.yaml. The Rotea admin user defines the directory where this file is to be found. That could be a shared directory, or a directory local to the ™... - Page 109 Chapter 4 OPC-UA interface Use case sequence diagrams ™ When DeltaV sends the index number, the Rotea GUI searches the pre-defined directory for the file OPCUAProtocolList.yaml, opens it and searches for the index number. If the index number is found, the protocol is loaded, and the status is reported to the OPC-UA server. ™...
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Page 110: Chapter 5 Maintenance
Maintenance User maintenance schedule The user is responsible for defining and implementing a suitable maintenance schedule based on their ™ specific usage of the Rotea instrument. WARNING! Regular maintenance should be scheduled with Thermo Fisher Scientific to ensure ™ correct operation of the instrument. Any modifications, revisions, maintenance or repair to the Rotea system shall be performed by Thermo Fisher Scientific approved technicians. -
Page 111: Open The Door Without Power
Chapter 5 Maintenance Open the door without power Open the door without power 1. Disconnect the instrument from power. 2. Insert 3mm hex key through the center of the door latch feature and engage the key firmly into the socket. 3. -
Page 112: Power And Fuses
Chapter 5 Maintenance Power and fuses Power and fuses Power supply The instrument power supply is rated to operate with international standard single-phase power. Specification: 90 - 264 VAC, Frequency 47 – 63 Hz, 240 Watts. Fuses The power inlet module houses 2 x 5A cartridge fuses, 5 mm diameter x 20 mm long, fast acting. •... -
Page 113: Chapter 6 Troubleshooting
Troubleshooting WARNING! Before performing any of the procedures described in this section, you must first read and understand all contents in prior sections of the user guide. Please ensure that you contact an approved Thermo Fisher Scientific representative if there is any doubt as to the use or maintenance ™... - Page 114 Chapter 6 Troubleshooting Power and fuses (continued) Component Fault Corrective action Door Door won’t unlock Check instrument status and that the door unlock button is illuminated Note: for instructions on how to open the door manually to retrieve a Single-Use Kit or perform maintenance, see “Open the door without power”...
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Page 115: Chapter 7 Compliance
Compliance ™ The Rotea instrument has been designed to comply with the following standards: 1. UL 61010-1:2012 2. UL 61010-2-020: 2017 3. UL 61010-2-081: 2015 4. CAN/CSA C22.2 No. 61010-1-12 5. CAN/CSA C22.2 No. 61010-2-020: 2017 6. CAN/CSA C22.2 No. 61010-2-081: 2015 7. -
Page 116: Chapter 8 Safety Instructions
Safety instructions Labels Safety label is located on the right side of the instrument. Emergency procedures This section describes the process for initiating an emergency shutdown and the consequence of a power failure. Instrument emergency stop events The instrument will automatically stop a running protocol if: •... -
Page 117: Emergency Shut Down
Chapter 8 Safety instructions Emergency procedures Instrument stop events are included for the safety of the operator and instrument. Where possible, warnings of problematic settings will be reported by the instrument if they can be identified before a stop is triggered. Emergency shut down The instrument can be shut down by the user in the following ways: Figure 19 Turn off the instrument using the on/off switch or disconnecting mains power. -
Page 118: Protocol Recovery Process
Chapter 8 Safety instructions Emergency procedures Protocol recovery process Once the conditions causing the fault have been addressed it may be possible to restart a protocol from a specific protocol step. Note: Unless there has been a breach of the closed fluidic system, the cells will have been retained in the system and are potentially recoverable. -
Page 119: Warnings And Precautions
Chapter 8 Safety instructions Warnings and precautions Warnings and precautions Warnings WARNING! ™ · The Rotea instrument is capable of producing liquid pressures up to 400 kPa if the flow is restricted. It is the users responsibility to ensure the volume of liquid pumped to any connected vessel does not exceed the rated volume of that vessel. -
Page 120: Cautions
Chapter 8 Safety instructions Warnings and precautions Cautions CAUTION! ™ · The Rotea system shall be used exclusively with the Single-Use Kit. The kits are for single use only and should be used within their stated expiration date. The user is responsible for appropriate storage, handling and disposal of the Single-Use Kit. -
Page 121: Appendix A Safety
Safety WARNING! GENERAL SAFETY. Using this product in a manner not specified in the user documentation may result in personal injury or damage to the instrument or device. Ensure that anyone using this product has received instructions in general safety practices for laboratories and the safety information provided in this document. -
Page 122: Standard Safety Symbols
Appendix A Safety Symbols on this instrument Standard safety symbols Symbol and description CAUTION! Risk of danger. Consult the manual for further safety information. CAUTION! Risk of electrical shock. CAUTION! Potential biohazard. Control and connection symbols Symbols and descriptions On (Power) Off (Power) Earth (ground) terminal Protective conductor terminal (main ground) - Page 123 Appendix A Safety Symbols on this instrument (continued) Conformity mark Description Indicates conformity with European Union requirements. Indicates conformity with Australian standards for electromagnetic compatibility. Indicates conformity with the WEEE Directive 2012/19/EU. CAUTION! To minimize negative environmental impact from disposal of electronic waste, do not dispose of electronic waste in unsorted municipal waste.
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Page 124: Safety Information For Instruments Not Manufactured By Thermo Fisher Scientific
Appendix A Safety Safety information for instruments not manufactured by Thermo Fisher Scientific Safety information for instruments not manufactured by Thermo Fisher Scientific Some of the accessories provided as part of the instrument system are not designed or built by Thermo Fisher Scientific. -
Page 125: Physical Injury
Appendix A Safety Instrument safety Physical injury CAUTION! Moving and Lifting Injury. The instrument is to be moved and positioned only by the personnel or vendor specified in the applicable site preparation guide. Improper lifting can cause painful and permanent back injury. Things to consider before lifting or moving the instrument or accessories: ·... -
Page 126: Cleaning And Decontamination
Appendix A Safety Safety and electromagnetic compatibility (EMC) standards Cleaning and decontamination CAUTION! Cleaning and Decontamination. Use only the cleaning and decontamination methods that are specified in the manufacturer user documentation. It is the responsibility of the operator (or other responsible person) to ensure that the following requirements are met: ·... -
Page 127: Emc Standards
Appendix A Safety Safety and electromagnetic compatibility (EMC) standards EMC standards Reference Description EU Directive 2014/30/EU European Union “EMC Directive” EN 61326-1 Electrical Equipment for Measurement, Control and Laboratory Use – EMC Requirements – Part 1: General Requirements IEC 61326-1 AS/NZS CISPR 11 Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific, and Medical (ISM) Radiofrequency Equipment... -
Page 128: Chemical Safety
Appendix A Safety Chemical safety Chemical safety WARNING! GENERAL CHEMICAL HANDLING. To minimize hazards, ensure laboratory personnel read and practice the general safety guidelines for chemical usage, storage, and waste provided below. Consult the relevant SDS for specific precautions and instructions: ·... -
Page 129: Biological Hazard Safety
Appendix A Safety Biological hazard safety Biological hazard safety WARNING! Potential Biohazard. Depending on the samples used on this instrument, the surface may be considered a biohazard. Use appropriate decontamination methods when working with biohazards. WARNING! BIOHAZARD. Biological samples such as tissues, body fluids, infectious agents, and blood of humans and other animals have the potential to transmit infectious diseases. -
Page 130: Appendix B Documentation And Support
Documentation and support Customer and technical support Visit thermofisher.com/support for the latest service and support information. • Worldwide contact telephone numbers • Product support information – Product FAQs – Software, patches, and updates – Training for many applications and instruments •... - Page 132 CTS Rotea Counterflow Centrifugation System_UG_MAN0018908-v3- GUID-41AFA96D-3226-4D9C-9495-7DDC7A8DE3B6-2020/08/19 02:09:53 en 15:56:03.916+01:00 thermofisher.com/support | thermofisher.com/askaquestion thermofisher.com 20 October 2020...
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