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Compliance

The Rotea

™

instrument has been designed to comply with the following standards:

UL 61010-1:2012

UL 61010-2-020: 2017

UL 61010-2-081: 2015

CAN/CSA C22.2 No. 61010-1-12

CAN/CSA C22.2 No. 61010-2-020: 2017

CAN/CSA C22.2 No. 61010-2-081: 2015

IEC 61010-1:2010

IEC 61010-2-020: 2016

IEC 61010-2-081: 2015

10.

EN 61010-1:2010

11.

EN 61010-2-020: 2017

12.

EN 61010-2-081: 2015

13.

European Low Voltage Directive 2014/35/EU

14.

EMC Directive 2014/30/EU

15.

EN 61326-1:2013 (Class A)

16.

IEC 61326-1:2012

17.

FCC 47 CFR Part 15 Subpart B

18.

ICES-001:Issue 4

19.

AS/NZS CISPR 11:2011

20.

RoHS, Directive 2011/65/EU

21.

China GB/T 26572-2011

, markings comply with

SJ/T 11364-2014

22.

REACH Regulation (EC) 1907/2006

23.

WEEE Directive 2012/19/EU

CTS

™

Rotea

™

Counterflow Centrifugation System User Guide

115

Содержание A44769

Страница 1: ...For Research Use or Manufacturing of Cell Gene or Tissue Based Products CTS Rotea Counterflow Centrifugation System USER GUIDE Catalog Number A44769 Publication Number MAN0018908 Revision A 0 ...

Страница 2: ...ion System is for use in further manufacturing applications only and not for final drug product formulation Drug manufacturers are responsible for ensuring the purity potency safety and identity of finished drug products and for obtaining the appropriate regulatory approvals Revision history Pub No MAN0018908 Revision Date Description A 0 20 October 2020 New document User guide for new workflow Im...

Страница 3: ...otea Single Use Kit schematic 14 Wetted components 15 Allowed chemicals for wetted surfaces 15 CHAPTER 2 Installation and setup 16 Packaging contents 16 Instrument installation 16 Power instrument On 18 Power instrument Off 19 Installation 20 First time setup 24 Download protocols 27 Create protocols 27 Load a protocol 27 Rotea GUI dashboard 31 User Management 32 Uninstall 37 Logging 38 CTS Rotea ...

Страница 4: ...rument firmware 75 OPC UA 80 Settings 81 Licenses 82 Calibration 83 CHAPTER 4 OPC UA interface 87 Introduction 87 Definitions 87 Scope of system 88 Instrument hardware configuration 88 Single Use Kit 88 Protocol file 89 Protocol metadata 89 MES interface 89 Background 89 Electronic communications 90 Communications protocol 90 MES Commands and reports overview 91 Enable OPC UA 92 Log in to instrume...

Страница 5: ...7 Use list file to load protocol 108 CHAPTER 5 Maintenance 110 User maintenance schedule 110 Instrument cleaning 110 Inspect casing 110 Open the door without power 111 Power and fuses 112 Power supply 112 Fuses 112 CHAPTER 6 Troubleshooting 113 CHAPTER 7 Compliance 115 CHAPTER 8 Safety instructions 116 Labels 116 Emergency procedures 116 Instrument emergency stop events 116 Emergency shut down 117...

Страница 6: ...124 General 124 Physical injury 125 Electrical safety 125 Cleaning and decontamination 126 Safety and electromagnetic compatibility EMC standards 126 Safety standards 126 EMC standards 127 Environmental design standards 127 Chemical safety 128 Biological hazard safety 129 APPENDIX B Documentation and support 130 Customer and technical support 130 Limited product warranty 130 Contents 6 CTS Rotea C...

Страница 7: ...ols depending on the application The system s open design and integrated camera allows users to visualize cells in real time to more easily optimize protocols Features CTS Rotea Counterflow Centrifugation System easily fits into existing workflows from research to commercial manufacturing Integrated camera provides real time sample visualization Patented technology that can process up to 20 L of s...

Страница 8: ...er Detector 6 CFC Chamber Carrier 7 Camera 8 Moisture Sensor 9 Pushbutton Controls 10 Optical Density Sensor Pressure Sensor P1 11 Peristaltic Pump 12 Pump Clamp Arm 13 Pinch Valve H 14 Kit Location Button Pressure Sensor P2 15 Door Latch 16 Pinch Valves A B C D E F G 17 Bubble Sensors 18 Hanger Posts Chapter 1 Product information System overview 1 8 CTS Rotea Counterflow Centrifugation System Use...

Страница 9: ...t Rear View 1 Power Switch 2 Mains Connector 3 CAN bus 2 off 4 Ethernet RJ 45 5 USB C 6 Bag Hooks 7 Hanger Post 8 Hanger Post Adjustment Chapter 1 Product information System overview 1 CTS Rotea Counterflow Centrifugation System User Guide 9 ...

Страница 10: ...e The 2 in 1 laptop is connected via a USB C cable and hence can be located in a range of positions The width dimension of 25 assumes that the laptop is located on the bench beside the instrument Instrument weight The Rotea instrument weighs 44 lbs 20 kg with hanger posts installed Chapter 1 Product information System overview 1 10 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 11: ...imum relative humidity 80 non condensing Altitude max 2000 m Indoor use only Not intended for use in a wet location Intended for use in Pollution degree 2 environment Operating limits Centrifuge speed 0 to 3000 g 7000 rpm Flow rate Standard 5 to 110 mL min LS19 Hi Flow 30 to 160 mL min LS16 tube System pressure 100 kPa Liquid temperature 4 to 38 Fluid density 1 0 to 1 1 g mL Minimum working volume...

Страница 12: ... batches Maximum bag weight per pole 4 4 lb 2 kg Output concentration Up to 300 106 cells mL cell type and operating parameters dependent CAN bus connection Purpose For connection and control of external devices Connector TE Connectivity T4111402051 000 M12 Plug Connections Pin 1 VCC CAN 5V out Pin 2 CAN H Dominant High Pin 3 CAN L Dominant Low Pin 4 GND Ground Pin 5 GND Shield optional Chapter 1 ...

Страница 13: ...utton to start the Protocol pause the current step in the protocol or re start a paused step Push button to advance to the next step in the protocol Push button to unlock the door Flashing Instrument has stopped due to an alarm condition User intervention is required Instrument is in a paused condition Pressing allows the instrument to continue the current step of the protocol Button can be pushed...

Страница 14: ... left sealed off 6 3 5 1 2 4 7 8 9 10 11 12 Figure 4 CTS Rotea Single Use Kit 1 Valve Hole Tube ID 2 Carrier Frame 3 Bubble Trap 4 Location Hole 5 CFC Chamber 6 Rotary Coupling 7 2D Barcode 8 Pump Tubing 9 Tube Retainer 10 Valve H Hole 11 Location Hole 12 Kit Tubing Input and Output Chapter 1 Product information System overview 1 14 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 15: ...Rotary Coupling O Rings EPDM 70 DURO FDA compliant Cannular 316 SS Cap Tritan MX711 Body Tritan MX711 Bush Collar Ketron LSG Peek Classix USP Class VI Bubble Trap Base Tritan MX711 Cap Tritan MX711 Fittings Triple Y Connector PVC Barbed T Connector Polyproylene Allowed chemicals for wetted surfaces Chemical Concentration Maximum exposure time WFI 100 5 minutes Ethanol in water 50 5 minutes Culture...

Страница 16: ...e addressed including adequately supporting the weight of the instrument and having sufficient wheel span so that both the trolley and instrument are stable Ensure that the bench is stable and level to within 0 4 10 mm Position the instrument on the bench with a minimum of 4 10 m between the rubber feet and the edges of the bench CAUTION The Rotea instrument weighs 40 lbs 18 kg excluding hanger ba...

Страница 17: ...g mains into power GPO 3 Connect the laptop to USB C port on the instrument using the USB C cable 4 Insert 2 off bag hanger posts adjust height to suit Kit and turn nut clockwise to secure in place 5 Adjust the instrument position on the bench where it is required Chapter 2 Installation and setup Instrument installation 2 CTS Rotea Counterflow Centrifugation System User Guide 17 ...

Страница 18: ...ent 1 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 Chapter 2 Installation and setup Power instrument On 2 18 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 19: ...C switch or mains power 1 CAUTION There is no automatic recovery procedure If a loss of power event has occurred see Restart after shut down on page 117 Chapter 2 Installation and setup Power instrument Off 2 CTS Rotea Counterflow Centrifugation System User Guide 19 ...

Страница 20: ...ace GUI software will need to be installed onto the Dell 2 in 1 laptop provided New releases of the Rotea GUI software will be available for download from thermofisher com 1 Download the Rotea X X X exe installer Chapter 2 Installation and setup Installation 2 20 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 21: ...nstalled 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 Chapter 2 Installation and setup Installation 2 CTS Rotea Counterflow Centrifugation System User Guide 21 ...

Страница 22: ...ng the start menu and searching for Check for updates 6 Click Check for updates Install now and restart the laptop as required This process may need to be repeated multiple times until Windows software is completely up to date Chapter 2 Installation and setup Installation 2 22 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 23: ...Vision Digital Camera USB Serial Port COM X SNAPI Imaging Interface Note If these devices are missing ensure the USB cable is plugged in the Rotea instrument is powered and on that there are no more Windows software updates to complete 9 The installation is now complete Move onto setting up the application for the first time Chapter 2 Installation and setup Installation 2 CTS Rotea Counterflow Cen...

Страница 24: ...oftware 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 Chapter 2 Installation and setup First time setup 2 24 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 25: ...d 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 Chapter 2 Installation and setup First time setup 2 CTS Rotea Counterflow Centrifugation System User Guide 25 ...

Страница 26: ...admin user to change the account details New users can be added with the button 6 Change the admin user account username password and the default directory for this user to find protocols Click Save for any changes 7 The configuration is now complete Chapter 2 Installation and setup First time setup 2 26 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 27: ... portal Users can also modify existing protocols or create entirely new protocols using the Rotea Protocol App that can be installed on any Windows PC laptop or tablet Protocols can be saved for future retrieval using the GUI The Rotea Protocol App can be accessed at any time by clicking on the icon on the desktop Load a protocol 1 Click on the Select a Protocol button Chapter 2 Installation and s...

Страница 28: ... Browse or Select a Protocol to browse for a protocol stored locally or on any connected devices Chapter 2 Installation and setup Download protocols 2 28 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 29: ...e 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 Chapter 2 Installation and setup Download protocols 2 CTS Rotea Counterflow Centrifugation System User Guide 29 ...

Страница 30: ...Chapter 2 Installation and setup Download protocols 2 30 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 31: ... 4 5 6 10 9 8 7 1 Live video of the spinning centrifuge chamber 2 Kit View for the current step 3 Instrument name 4 Protocol name and list of adjacent steps current step in bold 5 Username 6 Minimize screen 7 Dropdown menu 8 Shortcut to Step List 9 Manual speed adjustment buttons or keyed values 10 Resettable timer Chapter 2 Installation and setup Download protocols 2 CTS Rotea Counterflow Centrif...

Страница 32: ...User Management 1 Select User Management from the dropdown menu Chapter 2 Installation and setup Download protocols 2 32 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 33: ...2 Click on the icon to add a new user 3 Type in new Username and Password Chapter 2 Installation and setup Download protocols 2 CTS Rotea Counterflow Centrifugation System User Guide 33 ...

Страница 34: ...lick Add Account to save new user settings 8 Edit user account details including setting Access Level 9 Click Save or Cancel Note Edits to Access Level can only be performed by a user with admin rights Chapter 2 Installation and setup Download protocols 2 34 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 35: ...10 Select to delete a user 11 Click Confirm or Cancel Chapter 2 Installation and setup Download protocols 2 CTS Rotea Counterflow Centrifugation System User Guide 35 ...

Страница 36: ... can edit their profile by selecting Profile from the dropdown menu 13 Edit user profile fields 14 Click Save or Cancel Chapter 2 Installation and setup Download protocols 2 36 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 37: ...Uninstall 1 Open the Add or remove programs utility by searching for it in the start menu Chapter 2 Installation and setup Uninstall 2 CTS Rotea Counterflow Centrifugation System User Guide 37 ...

Страница 38: ...veral logs The main logs of interest to the user are the run logs which contain a run history of each run performed by the laptop The run log files are saved in C ProgramData Rotea logs run_logs The service logs are saved in C ProgramData Rotea logs service and may be required for warranty claims and to help resolve application issues Note The ProgramData directory is a hidden directory typing C P...

Страница 39: ...ou can also add notes to the run log Click Add Log Comment in the dropdown menu during a protocol run Chapter 2 Installation and setup Logging 2 CTS Rotea Counterflow Centrifugation System User Guide 39 ...

Страница 40: ... Write comment in the comment box and click Add Comment Chapter 2 Installation and setup Logging 2 40 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 41: ... unlock button is illuminated Instrument is not currently running a protocol Centrifuge carrier and peristaltic pump are stationary 1 Press pushbutton when it is illuminated to unlock the door 2 Open the door and raise until past vertical Note Soft close hinges prevent the door from opening or closing abruptly 3 CTS Rotea Counterflow Centrifugation System User Guide 41 ...

Страница 42: ... triggers the following Pinch valves retract Pump clamp is released Door is unlocked and partially opens Note If there is a Single Use Kit installed on the instrument unlocking the door will release the valves that are clamping the tubes of the kit closed Any fluids in bags or vessels attached to the kit will be free to flow Close all manual tube clamps before opening the door Chapter 3 Basic inst...

Страница 43: ...rument the Kit View on the Rotea GUI dashboard will display a schematic of the CTS Rotea Single Use Kit with bag connections Figure 6 Instrument with CTS Rotea Single Use Kit Chapter 3 Basic instrument operation Kit preparation loading and removal 3 CTS Rotea Counterflow Centrifugation System User Guide 43 ...

Страница 44: ... correct assembly and loading of the Single Use Kit prior to initiating an instrument protocol CAUTION Only use kits supplied by Thermo Fisher Scientific or its agents CAUTION Inspect each Single Use Kit for any damage or imperfections that may result in incorrect operation Do not use kit if any such defect is found Chapter 3 Basic instrument operation Kit preparation loading and removal 3 44 CTS ...

Страница 45: ...he sealed pouch and remove the Single Use Kit 2 Release the CFC Chamber from the Carrier Frame if still retained Chapter 3 Basic instrument operation Kit preparation loading and removal 3 CTS Rotea Counterflow Centrifugation System User Guide 45 ...

Страница 46: ...rile welding to compatible bags using devices that service the blood banking industry such as the TSCD II Sterile Tubing Welder TerumoBCT See the instructions provided by instrument providers for completion of sterile welding Figure 8 TSCD II Sterile Tubing Welder TerumoBCT Chapter 3 Basic instrument operation Kit preparation loading and removal 3 46 CTS Rotea Counterflow Centrifugation System Use...

Страница 47: ... instrument must include a suitable priming sequence to ensure air in fluid supply lines and the Bubble Trap is replaced with fluid prior to commencing processing Note If the length of tubing from the product supply bag has a volume greater than the Bubble Trap then air can enter the circuit It is therefore preferred that the length of tubing for each connection 1 8 ID assumed is less than 12 or 3...

Страница 48: ...t 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 Chapter 3 Basic instrument operation Kit preparation loading and removal 3 48 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 49: ...tall the CFC Chamber into the CFC Chamber Carrier a Load CFC Chamber into the CFC Chamber Carrier b Push CFC Chamber down into CFC Chamber Carrier to depress latch Chapter 3 Basic instrument operation Kit preparation loading and removal 3 CTS Rotea Counterflow Centrifugation System User Guide 49 ...

Страница 50: ... 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 Chapter 3 Basic instrument operation Kit preparation loading and removal 3 50 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 51: ...d insert the Tube Retainer into the Sensor Block to hold it in place Pump tube barbed connector correctly placed in the Sensor Block Chapter 3 Basic instrument operation Kit preparation loading and removal 3 CTS Rotea Counterflow Centrifugation System User Guide 51 ...

Страница 52: ...7 Insert tubing in Sensor Block channel Chapter 3 Basic instrument operation Kit preparation loading and removal 3 52 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 53: ...g 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 If not correctly located in the channel the tubing may be crushed when the door is closed Chapter 3 Basic instrument operation Kit preparation loading and removal 3 CTS Rotea Counterflow Centrifugation System User Gui...

Страница 54: ...Initiate a protocol 1 Click Initiate to commence running the protocol Chapter 3 Basic instrument operation Kit preparation loading and removal 3 54 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 55: ...se the door Note Soft close hinges prevent the door from dropping suddenly Chapter 3 Basic instrument operation Kit preparation loading and removal 3 CTS Rotea Counterflow Centrifugation System User Guide 55 ...

Страница 56: ... Closing the door initiates the following automatic system checks The status of each system check is displayed on the Rotea GUI with indicating correct installation of the Single Use Kit Chapter 3 Basic instrument operation Kit preparation loading and removal 3 56 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 57: ...system check are identified with a and will require the user to identify and rectify the source of the error Chapter 3 Basic instrument operation Kit preparation loading and removal 3 CTS Rotea Counterflow Centrifugation System User Guide 57 ...

Страница 58: ... engaged However manual clamps also represent a significant process hazard if left in the closed state Whilst the instrument should detect this failure mode as an over pressure fault it will stop the process potentially compromising the batch Release all manual clamps prior to starting the automatic sequence If required by the selected protocol 8 Enter data inputs Chapter 3 Basic instrument operat...

Страница 59: ...9 Click Confirm or Cancel Chapter 3 Basic instrument operation Kit preparation loading and removal 3 CTS Rotea Counterflow Centrifugation System User Guide 59 ...

Страница 60: ...atically sent to the instrument and the Rotea GUI dashboard is displayed for the new protocol Chapter 3 Basic instrument operation Kit preparation loading and removal 3 60 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 61: ...ation 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 Chapter 3 Basic instrument operation Run a protocol 3 CTS Rotea Counterflow Centrifugation System User Guide 61 ...

Страница 62: ...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 Chapter 3 Basic instrument operation Run a protocol 3 62 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 63: ...ress through each step in the protocol until the protocol is complete pre defined user intervention is required or an error occurs Chapter 3 Basic instrument operation Run a protocol 3 CTS Rotea Counterflow Centrifugation System User Guide 63 ...

Страница 64: ...s using the control buttons Reset Step Time Remaining Increase reduce Pump flow rate Increase reduce Centrifuge g force 6 Switch to the Step List to see a summary of all steps in the protocol Chapter 3 Basic instrument operation Run a protocol 3 64 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 65: ...7 Return to the dashboard by clicking on or using the dropdown menu Chapter 3 Basic instrument operation Run a protocol 3 CTS Rotea Counterflow Centrifugation System User Guide 65 ...

Страница 66: ...re liquid has been pumped in through a valve than has been pumped out reducing the bag volume The example shows that the net valve volumes are as follows 1 105 2 mL has been pumped out through valve A 2 76 0 mL has been pumped in through valve B 3 54 6 mL has been pumped in through valve D 4 24 9 mL has been pumped out through valve G 5 A small volume of 0 3 mL has been pumped out through valves E...

Страница 67: ...ockage Error messages Alarm or message Critical alarm Warning Instrument response GUI message Safety system error Yes Cut power to pump and centrifuge trigger instrument stop state Safety system error Protocol run has stopped Press the stop button on the instrument close manual clamps and open and close the instrument door to reset Restart the protocol or select a protocol step to start from If er...

Страница 68: ... open and close the instrument door to reset Restart the protocol or select a protocol step to start from If error persists abort the run Out of balance condition Yes Trigger instrument stop state Instrument out of balance Protocol run has stopped Press the stop button to clear the error then restart the protocol or select a step to start from If error persists abort the run Moisture in bowl Yes T...

Страница 69: ...ommunication error Yes Instrument continues running protocol GUI indicates error until communications are restored Communication error Ensure that the cable between the laptop interface and instrument is connected Kit removal CAUTION Seal all fluid lines using a tube sealer or manual clamps prior to unlocking the door to prevent fluid movement when the instrument pinch valves are released 1 Press ...

Страница 70: ...2 Open the door and raise until past vertical Chapter 3 Basic instrument operation Kit removal 3 70 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 71: ...Chamber from the CFC Chamber Carrier by lifting the lever and rotating the CFC Chamber back towards the latch Chapter 3 Basic instrument operation Kit removal 3 CTS Rotea Counterflow Centrifugation System User Guide 71 ...

Страница 72: ...4 Lift CFC Chamber clear of the Centrifuge Carrier Chapter 3 Basic instrument operation Kit removal 3 72 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 73: ...5 Remove the tubing from the Sensor Block and Peristaltic Pump Chapter 3 Basic instrument operation Kit removal 3 CTS Rotea Counterflow Centrifugation System User Guide 73 ...

Страница 74: ...lies to be disposed of separately or manually clamp tube connections to bags if preferred Dispose of used Single Use Kit in accordance with approved procedures Note The Single Use Kit tube materials are suitable for RF sealing using a SEBRA or Terumo Tube Sealer or equivalent Please consult the tube sealer supplier s manual for instructions on creating a sterile disconnection Chapter 3 Basic instr...

Страница 75: ...System settings Instrument firmware 1 Select Settings from the drop down menu Chapter 3 Basic instrument operation System settings 3 CTS Rotea Counterflow Centrifugation System User Guide 75 ...

Страница 76: ...2 Click on the Firmware tab 3 Select the latest firmware 4 Click Update Chapter 3 Basic instrument operation System settings 3 76 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 77: ...5 The selected firmware will be automatically updated Chapter 3 Basic instrument operation System settings 3 CTS Rotea Counterflow Centrifugation System User Guide 77 ...

Страница 78: ... The system will automatically reboot 7 Once firmware has updated successfully click Done Chapter 3 Basic instrument operation System settings 3 78 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 79: ...8 If firmware has not been updated click Done and restart the firmware update Chapter 3 Basic instrument operation System settings 3 CTS Rotea Counterflow Centrifugation System User Guide 79 ...

Страница 80: ...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 Chapter 3 Basic instrument operation System settings 3 80 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 81: ...ngs Admin users have the ability to update the instrument settings via the Rotea Settings tab Chapter 3 Basic instrument operation System settings 3 CTS Rotea Counterflow Centrifugation System User Guide 81 ...

Страница 82: ...are licenses are listed in the Licenses tab The detail for each license can be displayed by clicking on the v arrows Chapter 3 Basic instrument operation System settings 3 82 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 83: ...Calibration 1 Select Calibration from the drop down menu Chapter 3 Basic instrument operation Calibration 3 CTS Rotea Counterflow Centrifugation System User Guide 83 ...

Страница 84: ...ume 3 Input Actual Volume from calibration test run 4 Select Kit Type from the drop down list 5 Click Calibrate Chapter 3 Basic instrument operation Calibration 3 84 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 85: ...6 Click Save or Cancel Chapter 3 Basic instrument operation Calibration 3 CTS Rotea Counterflow Centrifugation System User Guide 85 ...

Страница 86: ...calibration is successful 8 If calibration was not successful click Done and restart the calibration process Chapter 3 Basic instrument operation Calibration 3 86 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 87: ...e Emerson DeltaV DeltaV is technically a Process Control System PCS but it incorporates all the functionality of a SCADA system and those are the functions that will be primarily used with the Rotea instrument Definitions Abbreviation Definition GUI Graphical User Interface DeltaV A Process Control System PCS made by Emerson ERP Enterprise Resource Planning MES Manufacturing Execution System PCS P...

Страница 88: ...rnal devices may also comprise a series of components managed by a self contained control that responds to purpose designed messages from the Rotea instrument s embedded through the CAN BUS Single Use Kit The Single Use Kit defines The fluidic connections between instrument components such as the pump and valves The size of the pump tubing for each pump Optionally the volume capacity of each attac...

Страница 89: ...ue based products For use in a qualified manufacturing processes the instrument Single Use Kit and protocol must be qualified and maintained fit for purpose for the application When a qualified process is run a record is required to verify that the process was performed in the formally defined way If any variation to the process operations occur then such events need to be documented and formally ...

Страница 90: ...on page 104 Figure 10 System components Communications protocol The MES interface to the Rotea instrument application will be through an implementation of OPC UA When enabled in the Rotea GUI an OPC UA server will run on the laptop allowing an MES OPC UA client to connect to it The commands and reports available to OPC UA client are outlined see MES Commands and reports overview on page 91 with de...

Страница 91: ...s overview Figure 11 Run protocol workflow For more use cases See Use case sequence diagrams on page 104 Chapter 4 OPC UA interface MES Commands and reports overview 4 CTS Rotea Counterflow Centrifugation System User Guide 91 ...

Страница 92: ...n login to the Rotea GUI at any time it does so by changing the SetGuiUserLevel node Full details of the SetGuiUserLevel values see OPC UA interface on page 96 Load protocol A protocol can be loaded three ways 1 SetLocalProtocolFilePath Sets the file path on the laptop of where to load the protocol file 2 SetProtocolFileContents Supply the protocol file contents to transfer to Rotea GUIRotea and t...

Страница 93: ... in the protocol metadata The MES can check ParameterValid1 to ParameterValid20 to determine the status of metadata definition for the protocol This will advise if that parameter is in use if it has been set and if the setting is valid To set the value use SetParameter1 through SetParameter20 and supply an Int32 value Initialize protocol on to instrument Once the protocol has been specified kit lo...

Страница 94: ...on the Rotea GUIor via the exposed OPC UA variables The ProtocolState will report ProtocolRunning or ProtocolPaused The ProtocolStepNumber reports the current step WaitingUserAck reports if the instrument is waiting for verification to proceed to the next step or repeat the current step The MES uses SetProtocolState to RunProtocol to repeat the same step or SkipToNextStep in response to this state...

Страница 95: ...single step in the existing protocol The MES can also log in a qualified user with administrative privileges to run the instrument from the Rotea GUI as a manual intervention All actions are recorded in the history files and instrument status is reported to the MES To return to MES managed operations the administrator user logs out of the MES The MES then logs in as ViewUser again The instrument c...

Страница 96: ...current instrument log in state SetLocalProtocolFilePath String Set the file name path of the protocol on the laptop to be loaded to the Rotea instrument SetPlayPauseButtonEnable Enum Enable the Play Pause button on the Rotea instrument Disabled AsPerProtocol Enabled SetProtocolFileContents String Send the protocol file contents to the laptop to be loaded to the Rotea instrument SetProtocolFileByL...

Страница 97: ...pNumber SkipToNextStep advances the protocol to the next step by ending this step SetRecoveryStepNumber UInt32 The recovery step number to start from Used by SetProtocolState SetSkipButtonEnable Enum Enable the advance button on the Rotea instrument Disabled AsPerProtocol Enabled Reports Rotea application to OPC UA Table 3 Variable set when changed Variable Type Value Description CentrifugeSpeed U...

Страница 98: ...tea application is connected to the instrument and communication is successful False The Rotea application cannot communicate with the instrument all commands will fail and the status is invalid SerialNumber String The serial number of the instrument set during manufacture UpTime UInt32 Number of seconds the server has been running updated every 10 seconds Chapter 4 OPC UA interface OPC UA interfa...

Страница 99: ...ent WaitingPressureAck Waiting for User acknowledge following pause on pressure trigger event UserPausedButton The user paused the protocol via the pause button on the instrument UserPausedOPCUA The user paused the protocol via the OPCUA interface In order to acknowledge the event The user can press a play advance buttons if enabled on the instrument The MES can write the ProtocolState to RunProto...

Страница 100: ...mp motor fault CentrifugeMotorError The instrument has raised a centrifuge motor fault ValveError The instrument has raised a valve error A valve may have failed to close or open properly OutOfBalanceError The instrument has raised an out of balance error the centrifuge may be out of balance MoistureInBowlError The instrument has raised a moisture in bowl error the kit may be leaking OverPressureC...

Страница 101: ...ol not loaded KitNotLoaded The kit is not loaded protocol not loaded KitNotValid The kit is not valid protocol not loaded InstrumentNotReady Changing to the specified ProtocolState cannot be performed from the current state RecoveryStepOutOfRange The ProtocolStepNumber is not a valid step in the protocol ProtocolListDoesNotExist OPCUAProtocolList yaml cannot be found ProtocolListCannotBeOpen Canno...

Страница 102: ...d20 Enum NotInUse Parameter not used in protocol NotSet Parameter needs to be set OutOfRange Parameter not in valid range Valid Parameter valid ProtocolState Enum NoProtocolSelected No protocol loaded in the application ProtocolSelected Protocol loaded in the application InstrumentReady Protocol and kit loaded and valid User can run recovery operations from this state ReadyToStart Protocol sent to...

Страница 103: ... no control OPCViewUser An OPC UA View user is logged in The GUI is in view only mode the OPC UA interface has full control OPCViewUser An OPC UA View user is logged in The GUI is in view only mode the OPC UA interface has full control OPCAdminUser An OPC UA Administration user is logged in The GUI has full control of the instrument OPC UA has no control ProtocolStepNumber UInt32 The protocol step...

Страница 104: ...Use case sequence diagrams MES run a protocol Figure 13 Run a simple protocol Chapter 4 OPC UA interface Use case sequence diagrams 4 104 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 105: ...Protocol with parametric data Figure 14 Run a simple protocol with parameters Chapter 4 OPC UA interface Use case sequence diagrams 4 CTS Rotea Counterflow Centrifugation System User Guide 105 ...

Страница 106: ...ps 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 Chapter 4 OPC UA interface Use case sequence diagrams 4 106 CTS Rotea Counterflow Centrifugation System User Guide ...

Страница 107: ...or recovery events with admin user Figure 18 Change user level to perform recovery with the Rotea GUI Chapter 4 OPC UA interface Use case sequence diagrams 4 CTS Rotea Counterflow Centrifugation System User Guide 107 ...

Страница 108: ...ory or a directory local to the Rotea instrument Each new entry is started with a id is an int32 so potentially a larger number The entries do not need to be in any order The first match to the id number is used There is no check for duplicate id entries Filename included path details Chapter 4 OPC UA interface Use case sequence diagrams 4 108 CTS Rotea Counterflow Centrifugation System User Guide...

Страница 109: ...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 Chapter 4 OPC UA interface Use case sequence diagrams 4 CTS Rotea Counterflow Centrifugation System User Guide 109 ...

Страница 110: ...ion procedure can be used to reduce microbiological levels on the Instrument between product batches or following accidental microbiological contamination With the Single Use Kit removed the instrument face and features may be decontaminated with light spraying with 70 isopropanol or ethanol 10 bleach solutions followed by a rinse of water or ethanol wipe with a lint free disposable cloth CAUTION ...

Страница 111: ...h the center of the door latch feature and engage the key firmly into the socket 3 Rotate the hex key clockwise to unlatch the door The total movement is 90 degrees to release the latch Chapter 5 Maintenance Open the door without power 5 CTS Rotea Counterflow Centrifugation System User Guide 111 ...

Страница 112: ...acting 250 VAC 5 Amp When required replacement of fuses is performed as follows 1 Turn off mains power and unplug the cable from the IEC connector at the rear of the instrument 2 Remove fuse cover 3 Remove faulty fuse 4 Check that the replacement fuse is the correct rating for your instrument see Instrument properties on page 11 5 Insert new fuse and replace fuse cover Chapter 5 Maintenance Power ...

Страница 113: ... and output vessels are connected to the correct fluid lines on the Single Use Kit Check tube connections such as tube welds are open Check pump tubing condition and that it is correctly located on the pump rollers Check viable circuit and that correct pinch valves are open Pump not rotating Check instrument status Check mains switch and instrument on off switch Contact Thermo Fisher Scientific Se...

Страница 114: ...lace Single Use Kit Wipe internal surface of centrifuge housing with a soft cloth or dry paper towel and restart Instrument External spill Wipe internal surface of centrifuge housing with a soft cloth or dry paper towel and restart the instrument Concentrate output volume Incorrect volume or highly variable output volume Check that your priming sequence eliminates air from fluid lines in the conce...

Страница 115: ...9 IEC 61010 2 081 2015 10 EN 61010 1 2010 11 EN 61010 2 020 2017 12 EN 61010 2 081 2015 13 European Low Voltage Directive 2014 35 EU 14 EMC Directive 2014 30 EU 15 EN 61326 1 2013 Class A 16 IEC 61326 1 2012 17 FCC 47 CFR Part 15 Subpart B 18 ICES 001 Issue 4 19 AS NZS CISPR 11 2011 20 RoHS Directive 2011 65 EU 21 China GB T 26572 2011 markings comply with SJ T 11364 2014 22 REACH Regulation EC 19...

Страница 116: ...y stop a running protocol if Mains power is lost The Moisture Sensor detects fluid leaking in the centrifuge chamber zone The Vibration Sensor detects out of balance condition One of the Pressor Sensors detects sustained pressure over the threshold An internal error of the centrifuge drive pump drive or valves is detected Safety relay contacts welded or intermittent Door closed sensors opening Doo...

Страница 117: ...g ways Figure 19 Turn off the instrument using the on off switch or disconnecting mains power Figure 20 Immediately stop all instrument functions by pressing the stop button Restart after shut down Prior to restarting the Rotea instrument ensure that the condition that caused the shut down has been rectified The instrument can now be restarted see Chapter 3 Basic instrument operation Chapter 8 Saf...

Страница 118: ...fic to the point in the program where the triggering event for the shut down occurred can be initiated Where this isn t possible manual intervention may be required to re locate the fluid containing cells into a known bag and conduct a custom protocol to recover the cells If power is not available or the instrument is not serviceable page 111 describes how to manually open the door to enable remov...

Страница 119: ... hazard Rotea instrument is not approved for use in a potentially explosive atmosphere Never exceed the operating limits stated in this document and on the system label Operation outside these limits could damage equipment and cause personal injury or death The kits are intended to be part of the biocontainment system however they are not to be relied on as the only means of safeguarding users and...

Страница 120: ...d disposal of the Single Use Kit Thermo Fisher Scientific shall not be held responsible for any consequences resulting from use of kits other than as specified in the user guide Please ensure that you contact an approved Thermo Fisher Scientific representative if there is any doubt as to the use of the Rotea system Chapter 8 Safety instructions Warnings and precautions 8 120 CTS Rotea Counterflow ...

Страница 121: ...l protective equipment gloves gowns eye protection and so on To obtain SDSs see the Documentation and Support section in this document Symbols on this instrument Symbols may be found on the instrument to warn against potential hazards or convey important safety information In this document the hazard symbol is used along with one of the following user attention words CAUTION Indicates a potentiall...

Страница 122: ...iptions On Power Off Power Earth ground terminal Protective conductor terminal main ground Direct current Alternating current Both direct and alternating current Conformity symbols Conformity mark Description Indicates conformity with safety requirements for Canada and U S A Indicates conformity with China RoHS requirements Appendix A Safety Symbols on this instrument A 122 CTS Rotea Counterflow C...

Страница 123: ...ive 2012 19 EU CAUTION To minimize negative environmental impact from disposal of electronic waste do not dispose of electronic waste in unsorted municipal waste Follow local municipal waste ordinances for proper disposal provision and contact customer service for information about responsible disposal options Appendix A Safety Symbols on this instrument A CTS Rotea Counterflow Centrifugation Syst...

Страница 124: ...g that is under pressure Extinguish any nearby flames if you use flammable solvents Do not use polymeric tubing that has been severely stressed or kinked Do not use polymeric tubing with tetrahydrofuran or nitric and sulfuric acids Be aware that methylene chloride and dimethyl sulfoxide cause polymeric tubing to swell and greatly reduce the rupture pressure of the tubing Be aware that high solvent...

Страница 125: ...box on its side and hold it stationary while someone else slides the contents out of the box Electrical safety WARNING Fuse Installation Before installing the instrument verify that the fuses are properly installed and the fuse voltage matches the supply voltage Replace fuses only with the type and rating specified for the unit Improper fuses can damage the instrument wiring system and cause a fir...

Страница 126: ...ith the manufacturer that the proposed method will not damage the equipment Safety and electromagnetic compatibility EMC standards The instrument design and manufacture complies with the following standards and requirements for safety and electromagnetic compatibility Safety standards Reference Description EU Directive 2014 35 EU European Union Low Voltage Directive IEC 61010 1 EN 61010 1 UL 61010...

Страница 127: ...tes uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense Environmental design standards Reference Descrip...

Страница 128: ...ocedures as recommended in the SDS Handle chemical wastes in a fume hood Ensure use of primary and secondary waste containers A primary waste container holds the immediate waste A secondary container contains spills or leaks from the primary container Both containers must be compatible with the waste material and meet federal state and local requirements for container storage After emptying a wast...

Страница 129: ...ndividuals should be trained according to applicable regulatory and company institution requirements before working with potentially biohazardous materials Follow all applicable local state provincial and or national regulations The following references provide general guidelines when handling biological samples in laboratory environment U S Department of Health and Human Services Biosafety in Mic...

Страница 130: ...ocols Certificates of Analysis Safety Data Sheets SDSs also known as MSDSs Note For SDSs for reagents and chemicals from other manufacturers contact the manufacturer Limited product warranty Life Technologies Corporation and or its affiliate s warrant their products as set forth in the Life Technologies General Terms and Conditions of Sale at www thermofisher com us en home global terms and condit...

Страница 131: ......

Страница 132: ...erflow 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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