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background image

EMC compliance

Reference

Description

IEC 60601-1-2

Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic
disturbances

IEC 61326-1

Electrical Equipment for Measurement, Control and
Laboratory Use – EMC Requirements – Part 1:
General Requirements

IEC 61000-3-2

Harmonic current Emissions

IEC 61000-3-3

Voltage changes, voltage fluctuations and flocker
emissions

IEC 61000-4-2

Electrostatic Discharge Immunity

IEC 61000-4-3

Radiated RF Electromagnetic Field Immunity

Immunity to proximity fields from RF wireless
communications equipment

IEC 61000-4-4

Electrical Fast Transient/Burst Immunity

IEC 61000-4-5

Surge Immunity

IEC 61000-4-6

Immunity to conducted disturbances induced by RF
fiedls

IEC 61000-4-8

Power-frequency Magnetic Field Immunity

IEC 61000-4-11

Voltage Dips, short Interruptions and Voltage
Variation Immunity

FCC Part 15 Subpart B (47 CFR)

U.S. Standard Radio Frequency Devices

ICES-001

Industrial, Scientific and Medical (ISM) Equipment

AS/NZS CISPR 11

Industrial, scientific and medical equipment -
Radiofrequency disturbance characteristics - Limits
and methods of measurement

Appendix E

Safety

Electromagnetic compatibility (EMC) standards

E

CTS

™

DynaCellect

™

Magnetic Separation System User Guide

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Summary of Contents for A55867

Page 1: ...ring of Cell Gene or Tissue Based Products CAUTION Not intended for direct administration into humans or animals CTS DynaCellect Magnetic Separation System USER GUIDE Catalog Number A55867 Publication Number MAN0026480 Revision A 0 ...

Page 2: ...TO THE EXTENT ALLOWED BY LAW THERMO FISHER SCIENTIFIC INC AND OR ITS AFFILIATE S WILL NOT BE LIABLE FOR SPECIAL INCIDENTAL INDIRECT PUNITIVE MULTIPLE OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THIS DOCUMENT INCLUDING YOUR USE OF IT Important Licensing Information These products may be covered by one or more Limited Use Label Licenses By use of these products you accept the terms a...

Page 3: ...view 11 Instrument dimensions 14 Working space 14 Instrument weight 14 Product specifications 15 CTS DynaCellect Single Use Kit schematic 17 Tube sets volume overview 18 Single Use Kit packaging 21 Wetted components 22 CHAPTER 2 Installation and setup 23 Packaging contents 23 Upon receiving the instrument 23 Unpack the instrument 24 Installing the instrument 28 Installation 28 Power instrument On ...

Page 4: ...rofile 42 Delete a user profile 43 Assign or remove administrator privileges 43 Manual mode 43 Manage protocols 44 Protocol parameters 45 Create protocols 45 Create protocol steps 54 Prompts 66 Run protocol 68 Pause protocol 78 Skip step 79 Stop protocol 80 Import a protocol 81 Export a protocol 83 Edit protocols 87 System settings 93 Software updates 93 OPC UA 96 CHAPTER 4 OPC UA interface 97 Int...

Page 5: ...s and reagents 127 Prepare consumables for a run 128 Example consumable configuration 128 Bags and connectors 130 Prepare bags for DPBS 1 HSA waste output cells 131 Prepare conical bag for bead input 134 Transfer the beads to bag with a vial adapter 135 Welding transfer bags to kit 137 Install CTS DynaCellect Cell Isolation Kit on the instrument 139 Install CTS DynaCellect Bead Removal Kit on the ...

Page 6: ...ms 162 System error list 163 BLDC error list 166 VCB error list 167 MCB error list 171 APPENDIX C Recommended instrument settings 173 About instrument 173 Recommended instrument settings 173 Instrument settings administrator only 174 Maintenance and service 176 Run history 177 APPENDIX D Related products 178 Additional products 178 APPENDIX E Safety 180 Symbols on this instrument 180 Safety labels...

Page 7: ...Electromagnetic compatibility EMC standards 188 Class A notice 188 EMC compliance 189 Environmental design standards 190 Electrical safety 190 Magnet Safety 191 Chemical safety 192 Biological hazard safety 193 Service personnel 193 Safety precautions 194 Return to use 195 APPENDIX F Documentation and support 196 Customer and technical support 196 Limited product warranty 196 Contents CTS DynaCelle...

Page 8: ...situated on a rocker which enables mixing of cells and beads during cell bead incubation Automated fluid management is achieved by a peristaltic pump and pinch valves allowing transfer of fluid between bags Fluid movement and pressure is monitored by bubble sensors and pressure occlusion sensors respectively Customizable software enables flexibility from process development to commercial manufactu...

Page 9: ...tect the CTS DynaCellect Magnetic Separation System from vibration and keep out of direct sunlight Instrument features Automated magnet Rocker Embedded Graphical User Interface eGUI with 8 touch screen display 800 px 600 px 8 GB storage capacity for protocols Fluidics panel 11 pinch valves 2 pressure occlusion sensors 2 bubble sensors peristaltic pump peristaltic pump cover Overfill detector Leaka...

Page 10: ... as links open the web pages for those products Item Source CTS DynaCellect Cell Isolation Kit A52300 CTS DynaCellect Bead Removal Kit A52301 Embedded Graphical User Interface eGUI features The embedded graphical user interface eGUI is where you control the instrument and user access See Chapter 3 Embedded graphical user interface eGUI user instructions Process development mode Parameters Magnet e...

Page 11: ...ted fields Do not bring tools equipment or personal items containing steel iron or other magnetic materials close to the magnets The strong magnetic field can erase magnetic media such as hard disc drive HDD memory devices disable ATM and credit cards and can damage some watches Strong magnetic fields can also cause serious injury to persons with implanted or attached medical devices such as pacem...

Page 12: ...altic pump 9 Bubble sensor 10 USB port 11 Emergency stop button 12 Embedded Graphical User Interface eGUI 13 Tube guide for upstream or downstream connection 14 Rocker guard 15 Rocker with integrated magnet 16 Leakage detection sensor and overfill detector 17 Tube guide 18 Nest Chapter 1 Product information System overview 1 12 CTS DynaCellect Magnetic Separation System User Guide ...

Page 13: ... Rear view 1 Exhaust filter 2 USB 2 0 port 3 USB wireless adaptor port 4 Ethernet 5 Power switch 6 Power cable inlet Chapter 1 Product information System overview 1 CTS DynaCellect Magnetic Separation System User Guide 13 ...

Page 14: ... designed for benchtop use and requires a working space of approximately height 495 mm 19 with pole base and 434 mm 17 without pole base width 749 5 mm 29 5 depth 562 mm 22 12 The system can also be placed on a cart Instrument weight The CTS DynaCellect Magnetic Separation System weighs 49 75 kg 109 7 lbs 50 6 kg 111 6 lbs with poles and bag hangers Chapter 1 Product information System overview 1 ...

Page 15: ...ent weight 49 75 kg 109 7 lbs 50 6 kg 111 6 lbs with poles and bag hangers Built in features 8 touch screen display 800 600 px Sound level Operating sound level 73 dBA measured 1 m from instrument Non operating sound level 63 dBA measured 1 m from instrument Environmental ranges Ambient temp 15 C to 30 C Transport temperature 30 C to 60 C extreme end temperatures at maxium 72 hours Storage tempera...

Page 16: ... mm 1 4 Height rocker lid bead removal 5 mm 0 2 Overfilled detection 1120 mL static and rocking Magnet Magnet dimensions 265 205 mm 10 4 8 07 Magnetic strength 6000 G Pole Max height 1070 mm 42 13 from the bottom of the rubber foot of the instrument to the tip of the bag hanger hook point Pole adaptor Max weight 3 kg 6 6 lbs per hook on bag hanger Total 15 kg 33 lbs per bag hanger Use Indoor use o...

Page 17: ...ation bag Figure 3 CTS DynaCellect Cell Isolation Kit Cat No A52300 8 weldable PVC lines 150 mm 5 91 length 2 4 mm 0 094 ID 4 0 mm 0 157 OD Sterile air filter 0 20 micron Max capacity of isolation bag 1000 mL Ease of use cassette and tube holder for loading of tubing set Chapter 1 Product information System overview 1 CTS DynaCellect Magnetic Separation System User Guide 17 ...

Page 18: ... Kit at 15 30 C CAUTION The CTS DynaCellect Single Use Kit Cat Nos A52300 and A52301 have been validated for one time use by customers Single Use Kits are not recommended to be washed re sterilized or reused as sterility and quality of these kits have not been validated for multiple uses Tube sets volume overview The Single Use Kits consist of three different tubing silicone bioprene and PVC The t...

Page 19: ...linder is V π r2 h Note The volume in mL for each tube is indicated in Figure 6 This enables you to adjust for modifications to the input output line by e g welding particularly short or long tube lines While it is recommended to keep the welding distance from the Single Use Kits to cell bead buffer bags consistent between runs using the same protocol note that the dead volume per inch cm is relat...

Page 20: ... 1 3 3 7 2 3 0 8 Figure 6 Dead volume in Single Use Kits Cell isolation kit left and Bead removal kit right The numbers show the volume mL for each tube 1 PVC mL per in 0 11 mL per cm 0 05 2 Silicone mL per in 0 2 mL per cm 0 08 3 Bioprene mL per in 0 2 mL per cm 0 08 Chapter 1 Product information System overview 1 20 CTS DynaCellect Magnetic Separation System User Guide ...

Page 21: ...heet 4 Die cut box 5 PE foam bottom 6 Shipper box 1 2 5 6 4 3 Figure 7 Single Use Kit packaging Carton box Quantity 5 Single Use Kits 460 mm 18 11 L 300 mm 11 81 W 350 mm 13 78 H Chapter 1 Product information System overview 1 CTS DynaCellect Magnetic Separation System User Guide 21 ...

Page 22: ... 125 in ID 0 25 in OD Silicone Fittings Barbed straight connector Polypropylene Barbed tee connector Polypropylene Barbed cross connector Polypropylene Check valve Female luer lock inlet Barbed outlet SAN MABS Silicone Sterile filter syringe filter Minisart Polyesthersulfone MABS Barbed straight reducer EVA Barbed bag output port EVA Bags Isolation Bag EVA Bead removal Bag EVA Chapter 1 Product in...

Page 23: ... the carton has been damaged in transit it is particularly important that you retain it for inspection by the carrier in case there has also been damage to the instrument Any damage claims must be filed with the carrier Neither the manufacturer nor its agents can be held responsible for any damage incurred in transit Upon receipt of the carrier s inspection report arrangements will be made for rep...

Page 24: ...t faces a wall ensure that there is sufficient clearance on the bench to rotate the instrument for access WARNING Do not place the instrument adjacent to or stack with other equipment to avoid improper operation If this type of placement is necessary all the instruments and equipment should be observed to ensure that they operate normally Use of accessories transducers and cables other than those ...

Page 25: ...2 Remove the two small cardboard boxes 3 Remove the top foam 1 1 Top foam Chapter 2 Installation and setup Unpack the instrument 2 CTS DynaCellect Magnetic Separation System User Guide 25 ...

Page 26: ...strument to the bench or cart The operation require two persons Use the four holding recesses front left side back right side and on both sides to lift in diagonal position Chapter 2 Installation and setup Unpack the instrument 2 26 CTS DynaCellect Magnetic Separation System User Guide ...

Page 27: ...applied after the rocker has moved to its resting position 1 1 Rocker homing position foam 7 Unpack the two small cardboard boxes 2 bag hangers 2 pole extensions and 2 pole adaptors A summary of the unpacking and installation instructions are also provided in the CTS DynaCellect Magnetic Separation System Installation Guide Pub No 1100117621 Chapter 2 Installation and setup Unpack the instrument 2...

Page 28: ...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 cm between the rubber feet and the edges of the bench CAUTION The DynaCellect instrument weighs 49 75 kg 109 7 lbs 50 6 kg 111 6 lbs with poles and bag hangers Use appropriate care and seek assistance if necessary when lifting or moving the instrument Use the holding...

Page 29: ...e pole adaptor on top of the pole extension and tighten with a 2 mm allen key Repeat with the second pole extension and pole adaptor Chapter 2 Installation and setup Installing the instrument 2 CTS DynaCellect Magnetic Separation System User Guide 29 ...

Page 30: ... pole bases on the instrument Turn to tighten 2 1 2 3 3 1 Pole adaptor 2 Pole extension 3 Pole base 5 Place the bag hangers on the pole adaptors Chapter 2 Installation and setup Installing the instrument 2 30 CTS DynaCellect Magnetic Separation System User Guide ...

Page 31: ...loosen the nut shown in red circle pull the pole upwards and tighten the nut 7 The instrument is installed Chapter 2 Installation and setup Installing the instrument 2 CTS DynaCellect Magnetic Separation System User Guide 31 ...

Page 32: ...tialized by itself which will take 90 seconds Power instrument Off Switch off using the mains IEC switch at the rear right side of the instrument 1 1 Power button CAUTION There is no automatic recovery procedure If a loss of power event has occurred see Restart after shut down on page 156 Chapter 2 Installation and setup Power instrument On 2 32 CTS DynaCellect Magnetic Separation System User Guid...

Page 33: ...n the home screen the main user interaction points are shown in the following figure How to create and run protocols is described in the next sections 2 10 6 9 8 4 1 7 5 3 1 Menu 2 Open close pinch valves 3 Manual mode for executing single steps 4 Edit delete export and import protocols 5 Time and date 6 Create protocols from scratch and from existing 7 User 8 Run pre made protocols 9 Adjust rocke...

Page 34: ...ls Export protocols Delete protocols Unlock rocker lid Unlock rocker lid Rocker angle Adjust the rocker angle Open close pinch valves Open and close pinch valves Manual mode Manual mode for executing single steps For more details on how to create a step see page 54 Chapter 3 Embedded graphical user interface eGUI user instructions User interface overview 3 34 CTS DynaCellect Magnetic Separation Sy...

Page 35: ...indicators Button Function Indicates whether a USB device is inserted into the instrument Indicates whether the instrument is connected to wired network Guest Indicates user Chapter 3 Embedded graphical user interface eGUI user instructions Touch screen controls 3 CTS DynaCellect Magnetic Separation System User Guide 35 ...

Page 36: ... as seen in the following figure opens 5 3 2 4 1 1 Enter a letter 2 Change letter case 3 Close and save 4 Delete 5 Close without saving Chapter 3 Embedded graphical user interface eGUI user instructions Touch screen controls 3 36 CTS DynaCellect Magnetic Separation System User Guide ...

Page 37: ...1 Close without saving 2 Delete 3 Enter a number 4 Close and save Connect the instrument to the internet The instrument can connect to the internet with the Ethernet cable Chapter 3 Embedded graphical user interface eGUI user instructions Connect the instrument to the internet 3 CTS DynaCellect Magnetic Separation System User Guide 37 ...

Page 38: ... to an Ethernet port wall plug for port location see System overview on page 11 1 On the Home screen select Menu 2 In the Menu screen select Settings Chapter 3 Embedded graphical user interface eGUI user instructions Connect the instrument to the internet 3 38 CTS DynaCellect Magnetic Separation System User Guide ...

Page 39: ...rument settings 4 In the Instrument Settings screen select Network configuration Chapter 3 Embedded graphical user interface eGUI user instructions Connect the instrument to the internet 3 CTS DynaCellect Magnetic Separation System User Guide 39 ...

Page 40: ...atic to enter an IP address manually then enter the appropriate IP addresses for the instrument the Subnet Mask and optionally the Default Gateway the Primary DNS Server and the Secondary DNS Server using the numeric editor Addresses are in the form of X X X X where each X is a number from 001 to 255 Chapter 3 Embedded graphical user interface eGUI user instructions Connect the instrument to the i...

Page 41: ...word protected profile Access can also be granted without password via the Guest user Protocols made with the Guest user is only available to the Guest user whereas the password protected generated protocols are limited to the respective users 1 Select Menu 2 Select Sign In Get started Create profile 3 Fill in the required text fields and enter a four digit PIN to create your user profile Note The...

Page 42: ...dministrator only Delete a PIN Administrator only Change a user PIN 1 Select Profile 2 Select Reset PIN 3 Enter old PIN 4 Enter a new four digit PIN 5 Confirm new PIN by re entering the new PIN 6 Select Reset PIN Delete a user PIN If a password is forgotten an administrator can delete the existing password to allow a new one to be created This function resets a PIN so the user with a deleted PIN i...

Page 43: ...rivileges 1 Select All profiles 2 Select the account to be modified 3 Switch the toggle to Yes to grant privileges or No to remove privileges Manual mode Manual mode can be used to execute single steps without creating a protocol 1 From the home screen select Manual mode Chapter 3 Embedded graphical user interface eGUI user instructions Manual mode 3 CTS DynaCellect Magnetic Separation System User...

Page 44: ...created or Template protocols by selecting Run Protocol on the Home screen If a new protocol is required there are two methods for creating a new protocol Use Create protocol and select Create new to create a new protocol see Create protocols on page 45 Use Create protocol and select Create from Existing to created a protocol from an existing protocol see Create from existing protocol on page 48 C...

Page 45: ...in a step which are magnet rocker and pump The setting of these should be considered for each step An isolation and bead removal protocol comprises numerous steps and the system allows users to create protocols exactly like they want to Keep in mind that what may appear as a single step at the high level may need to be broken down into substeps For example drain isolation bag can be broken down in...

Page 46: ...xisting feature where you can edit add and remove steps to existing protocols Alternatively you can edit the existing protocols directly without creating a new one using the Manage function in the home screen Users can create new protocols using the eGUI From the Home screen select Create Protocol Create new Create new is for creating protocols from scratch without any pre existing steps 1 In the ...

Page 47: ...s as reference or instruction Select See kit details to proceed 3 In the Isolation Protocol Kit Details screen the sites can be labelled the site label does not influence the instrument behavior it only informs users what content should be on the specific lines for the protocol in question Site A Isolation Bag is default when the isolation kit is chosen Select Bead location to proceed Chapter 3 Em...

Page 48: ...nt behavior itself It is recommended to add some dead volume to the minimum volume requirement to account for user dependent preparations of solutions and consumables Select Create steps to proceed For instruction on how to make steps see Create protocol steps on page 54 Note Swipe the screen to scroll up or down Create from existing protocol Create from existing is for creating protocols from an ...

Page 49: ...reen select Create from existing 2 Select Cell isolation protocol or Bead removal protocol Chapter 3 Embedded graphical user interface eGUI user instructions Manage protocols 3 CTS DynaCellect Magnetic Separation System User Guide 49 ...

Page 50: ...r created or Template Select Open to proceed 4 In Protocol name field enter a name for the new protocol Select Edit sites Chapter 3 Embedded graphical user interface eGUI user instructions Manage protocols 3 50 CTS DynaCellect Magnetic Separation System User Guide ...

Page 51: ...hen the isolation kit is chosen Select Bead location to proceed 6 In the Select All Bead Site Locations screen select site location of your beads the identification of the bead site is needed to update the batch specific bead volume in Run Protocol mode as output from the bead calculator Select Edit volumes to proceed Chapter 3 Embedded graphical user interface eGUI user instructions Manage protoc...

Page 52: ...s bead to target cell ratio and bead stock concentration The calculator only provides the volume of beads the user needs to add to the bead bag it does not influence the protocol itself The standard bead stock concentration of CTS Dynabeads CD3 CD28 is 4 108 beads mL but may vary 10 from batch to batch The batch specific concentration can be found in the Certificate of Analysis CoA for the beads 1...

Page 53: ...bead stock concentration is not necessary assume the bead stock concentration 4 108 beads mL and thus bead volume is the same for every run regardless of batch Note Take note of the resulting volume of beads from the bead calculator to enter into the bead site in the Kit and Consumable Volumes screen Chapter 3 Embedded graphical user interface eGUI user instructions Manage protocols 3 CTS DynaCell...

Page 54: ...ttings 7 Bubble sensor settings 8 Pump settings 9 Create next step by duplicating current 10 Navigate steps 11 Cancel protocol writing 12 Review all steps Table 2 Features of the Create step view Feature Details Magnet Can be on or off When a duration is set for the magnet it determines how long the rocker will be in the specified position before moving to the next step Rocker When off a static an...

Page 55: ...e allowing the subsequent step to be initiated Duplicate step This button creates the next step in protocol It does so by duplicating the current step with the assumption that the next step will build on the current Forward backward arrows When 1 step has been created the steps can be navigated through using the forward backward buttons Cancel When this is selected the protocol and protocol setup ...

Page 56: ... 2 All steps are shown here Drag and drop to change sequence of steps 3 Duplicate current step 4 For editing multiple steps 5 Delete selected step 6 Cancel protocol writing 7 Edit selected step 8 Save protocol 9 Rename selected step 10 Details of step 11 Protocol name When a protocol has been saved it will be accessible in Run protocol which is used for running premade protocols It will also be vi...

Page 57: ...Fluid and air movement 1 Go to the Create screen Chapter 3 Embedded graphical user interface eGUI user instructions Manage protocols 3 CTS DynaCellect Magnetic Separation System User Guide 57 ...

Page 58: ...ifferent options fluid can be transferred to 3 Select the line you want to transfer the fluid to Only liquid movement through the pump is valid e g you cannot transfer liquid from D to H The selected fluid line becomes highlighted Chapter 3 Embedded graphical user interface eGUI user instructions Manage protocols 3 58 CTS DynaCellect Magnetic Separation System User Guide ...

Page 59: ...rm Bubble sensor The bubble sensor located to the left of the pump can be enabled to stop the pump when the bubble sensor is wet or dry When the bubble sensor is triggered the pump will stop pumping even if the intended pump volume has not been transferred As such the bubble sensor is a way of overriding the pump once a parameter has been met the bubble sensor detects liquid or air Chapter 3 Embed...

Page 60: ...ensor 2 In the state where the bubble sensor is inactive it will not interfere with pumping Chapter 3 Embedded graphical user interface eGUI user instructions Manage protocols 3 60 CTS DynaCellect Magnetic Separation System User Guide ...

Page 61: ...ghlighted in blue on the screen Note The bubble sensor detects air gaps of a duration of 500 milliseconds Note When activating the bubble sensor it is recommended to add a prompt see Prompts on page 66 to act as a gatekeeper before the protocol moves to the next step Chapter 3 Embedded graphical user interface eGUI user instructions Manage protocols 3 CTS DynaCellect Magnetic Separation System Use...

Page 62: ...he entire step duration The duration windows are grey reflecting that the duration cannot currently be altered This is because the duration of the pump determines the step duration 42 seconds as shown in the following image which means the rocker cannot have a different duration within the same step Chapter 3 Embedded graphical user interface eGUI user instructions Manage protocols 3 62 CTS DynaCe...

Page 63: ...ration windows are grey reflecting that the duration cannot currently be altered This is because the duration of the pump determines the step duration 42 seconds as shown in the previous image which means the rocker cannot have a different duration within the same step Chapter 3 Embedded graphical user interface eGUI user instructions Manage protocols 3 CTS DynaCellect Magnetic Separation System U...

Page 64: ...hanged This is a static movement if the rocker stays the same as in the previous step or it will be a single step rocker movement not continuous Now as the pump is inactive a duration for the rocker can be set The duration starts counting down when the rocker has reached the target angle Chapter 3 Embedded graphical user interface eGUI user instructions Manage protocols 3 64 CTS DynaCellect Magnet...

Page 65: ...aged reflected by the magnet upward position With step duration When the magnet is set to On with step duration first the magnet will be engaged and then the rocker will move to the target angle After the rocker has moved to the target angle then the step timer will start counting down Chapter 3 Embedded graphical user interface eGUI user instructions Manage protocols 3 CTS DynaCellect Magnetic Se...

Page 66: ...equent step to be initiated 1 Select prompt 2 Insert desired text into the Prompt field and select Enter Note If the rocker magnet is active the assigned activity will be continued despite the set duration until the prompt is acknowledged and the run is resumed Chapter 3 Embedded graphical user interface eGUI user instructions Manage protocols 3 66 CTS DynaCellect Magnetic Separation System User G...

Page 67: ... the step where the prompt was added The user is then prompted to acknowledge completion of the step and choose Next Step Repeat Step or Abort Run Chapter 3 Embedded graphical user interface eGUI user instructions Manage protocols 3 CTS DynaCellect Magnetic Separation System User Guide 67 ...

Page 68: ...ct Run protocol 2 In the Open Protocols screen select Cell isolation protocol or Bead removal protocol Chapter 3 Embedded graphical user interface eGUI user instructions Run protocol 3 68 CTS DynaCellect Magnetic Separation System User Guide ...

Page 69: ...ocols during Create or Manage if that is necessary to ensure the correct protocol has been selected Examples of protocol details submitted during Create or Manage which helps ensure that the correct protocol is selected for running Navigate between the two screens by swiping Chapter 3 Embedded graphical user interface eGUI user instructions Run protocol 3 CTS DynaCellect Magnetic Separation System...

Page 70: ...ocol and then Begin setup 6 In the Setup screen it is informed that an Cell Isolation Kit is required Chapter 3 Embedded graphical user interface eGUI user instructions Run protocol 3 70 CTS DynaCellect Magnetic Separation System User Guide ...

Page 71: ... proceed 8 To get bead volume for the specific bead lot enter the number of target cells and bead to target cell ratio same as used in Create and the bead stock concentration from the CoA If 100 accurate bead stock is not necessary assume bead stock is 4 108 mL Select Enter to proceed Chapter 3 Embedded graphical user interface eGUI user instructions Run protocol 3 CTS DynaCellect Magnetic Separat...

Page 72: ...r installing the kit Select Confirm when all bags have been prepared connected to the kit and kit installed on the instrument 11 Confirm Installation is the final screen before the run is initiated and includes important check points to go through before starting the run Note The most common error is to start the run without having opened clamps on the buffer cell bead bags which are not controlle...

Page 73: ...o start the protocol from a chosen step Press Select step then choose the step you want to start from and select Jump start Chapter 3 Embedded graphical user interface eGUI user instructions Run protocol 3 CTS DynaCellect Magnetic Separation System User Guide 73 ...

Page 74: ...s all acting as run monitors with differing levels of detail 14 The second view style with high level details for the rocker magnet and pump Table 3 Symbols second view screen Symbol Description Air flow Liquid flow Chapter 3 Embedded graphical user interface eGUI user instructions Run protocol 3 74 CTS DynaCellect Magnetic Separation System User Guide ...

Page 75: ...w style with all step details included When the run has completed it is possible to see the summary report by swiping to the left Select Add notes to add notes to the Summary Report The Summary Report can be exported by selecting Export Chapter 3 Embedded graphical user interface eGUI user instructions Run protocol 3 CTS DynaCellect Magnetic Separation System User Guide 75 ...

Page 76: ...Chapter 3 Embedded graphical user interface eGUI user instructions Run protocol 3 76 CTS DynaCellect Magnetic Separation System User Guide ...

Page 77: ...r network drive 17 In the Report screen Select Close to get instructions on how to remove the kit from the instrument Select Next in the Disconnect screen to follow the instructions Chapter 3 Embedded graphical user interface eGUI user instructions Run protocol 3 CTS DynaCellect Magnetic Separation System User Guide 77 ...

Page 78: ... Note If the rocker magnet is active their assigned activity will be continued until the run is resumed 2 To resume the run select Resume run It is also possible to add prompts during Create Protocol or Manage to force the user to acknowledge that certain actions are performed during the run See Prompts on page 66 Chapter 3 Embedded graphical user interface eGUI user instructions Pause protocol 3 ...

Page 79: ... to skip steps when a protocol is running 1 Select Skip step on screen number two or three Chapter 3 Embedded graphical user interface eGUI user instructions Skip step 3 CTS DynaCellect Magnetic Separation System User Guide 79 ...

Page 80: ...tocol can be stopped by selecting Stop run on all the three run view screens 1 The following screen will pop up Confirm stopping the run by selecting Yes Chapter 3 Embedded graphical user interface eGUI user instructions Stop protocol 3 80 CTS DynaCellect Magnetic Separation System User Guide ...

Page 81: ... to the Summary Report The summary report can be exported by selecting Export Import a protocol Protocols can be imported from the following locations USB memory device Network drive Chapter 3 Embedded graphical user interface eGUI user instructions Import a protocol 3 CTS DynaCellect Magnetic Separation System User Guide 81 ...

Page 82: ...ell isolation protocol or Bead removal protocol depending on which protocol that is going to be imported Chapter 3 Embedded graphical user interface eGUI user instructions Import a protocol 3 82 CTS DynaCellect Magnetic Separation System User Guide ...

Page 83: ... the platform to import the protocol from Export a protocol Protocols can be exported to the following locations USB memory drive Network drive Chapter 3 Embedded graphical user interface eGUI user instructions Export a protocol 3 CTS DynaCellect Magnetic Separation System User Guide 83 ...

Page 84: ...ell isolation protocol or Bead removal protocol depending on which protocol that is going to be exported Chapter 3 Embedded graphical user interface eGUI user instructions Export a protocol 3 84 CTS DynaCellect Magnetic Separation System User Guide ...

Page 85: ...Protocols screen select Export 4 In the Export screen select the protocols to export Chapter 3 Embedded graphical user interface eGUI user instructions Export a protocol 3 CTS DynaCellect Magnetic Separation System User Guide 85 ...

Page 86: ...want to export to USB drive or network drive 6 When the export is complete the following screen will show Chapter 3 Embedded graphical user interface eGUI user instructions Export a protocol 3 86 CTS DynaCellect Magnetic Separation System User Guide ...

Page 87: ...l from the Home screen select Manage 2 Choose to edit an Cell isolation protocol or Bead removal protocol Chapter 3 Embedded graphical user interface eGUI user instructions Edit protocols 3 CTS DynaCellect Magnetic Separation System User Guide 87 ...

Page 88: ...ation Protocols screen select Edit 4 Select a protocol and select Edit to proceed Chapter 3 Embedded graphical user interface eGUI user instructions Edit protocols 3 88 CTS DynaCellect Magnetic Separation System User Guide ...

Page 89: ...it sites to proceed 6 In the Edit sites screen the sites can be labelled the site label does not influence the instrument behavior it only informs users what content should be on the specific lines for the protocol in question Site A Isolation Bag is default when the isolation kit is chosen Select Bead location to proceed Chapter 3 Embedded graphical user interface eGUI user instructions Edit prot...

Page 90: ...s information is for instructional purposes when running the specific protocol and does not influence the instrument behavior itself It is recommended to add some dead volume to the minimum volume requirement to account for user dependent preparations of solutions and consumables Select Review steps to proceed For instruction on how to make steps see Create protocol steps on page 54 Chapter 3 Embe...

Page 91: ...r select Back to Create to edit duplicate steps in create mode 10 In the Create screen select Review to get back to the review mode Chapter 3 Embedded graphical user interface eGUI user instructions Edit protocols 3 CTS DynaCellect Magnetic Separation System User Guide 91 ...

Page 92: ...edited a protocol the following message will show Select Yes to save the new changes to the protocol Chapter 3 Embedded graphical user interface eGUI user instructions Edit protocols 3 92 CTS DynaCellect Magnetic Separation System User Guide ...

Page 93: ...cated to the right of the eGUI and below the emergency stop button 1 On the Home screen select Menu 2 In the Menu screen select Settings Chapter 3 Embedded graphical user interface eGUI user instructions System settings 3 CTS DynaCellect Magnetic Separation System User Guide 93 ...

Page 94: ...en select Software update 5 Insert the USB drive and select the software update file IMPORTANT Remember to backup the data before updating the software Chapter 3 Embedded graphical user interface eGUI user instructions System settings 3 94 CTS DynaCellect Magnetic Separation System User Guide ...

Page 95: ...ait for the software update process to complete 3 to 5 minutes Chapter 3 Embedded graphical user interface eGUI user instructions System settings 3 CTS DynaCellect Magnetic Separation System User Guide 95 ...

Page 96: ...e CTS DynaCellect Magnetic Separation System 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 Embedded graphical user interface eGUI user instructions OPC UA 3 96 CTS DynaCellect Magnetic Separation System User Guide ...

Page 97: ...and unload a protocol Start a protocol run Pause and resume run Abort a run Each DynaCellect instrument will have an OPC UA server installed together in the package for a client server based communication to perform data exchange with the DeltaV System OPC Unified Architecture OPC UA is a machine to machine protocol communication for industrial automation developed by the OPC Foundation Definition...

Page 98: ...ent 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 reviewed before the product can be released An MES interface is a communicat...

Page 99: ...em The Instrument Server will be the main interface performing back end logic to support both eGUI and OPC UA Server interactions The DeltaV system will establish login authentication and communication exchange with the OPC server that is a part of DynaCellect system Chapter 4 OPC UA interface MES Interface 4 CTS DynaCellect Magnetic Separation System User Guide 99 ...

Page 100: ...S applications will be located externally to the CTS DynaCellect Magnetic Separation System Communications by any MES system to the instrument will be through the CTS DynaCellect Magnetic Separation System embedded OPC UA software installed in the instrument Initial OPC UA Setup User will have to configure OPC initial settings if it is a first time user In the following screen the user will have t...

Page 101: ...s There are 2 available option for OPC client authentication The user can either select authentication via SSL certificate or username and password A copy of the certificate from the OPC UA client DeltaV must be saved on a USB disk before proceeding with the instructions below Also the OPC endpoint URL port number i e opc tcp ip address port ThermoFisher can be edited here Chapter 4 OPC UA interfa...

Page 102: ...the following to setup the login credential via SSL certificate Import the certificate from the OPC UA client s DeltaV system trust store Export DynaCellect OPC UA server certificate for import to client side Chapter 4 OPC UA interface Initial OPC UA Setup 4 102 CTS DynaCellect Magnetic Separation System User Guide ...

Page 103: ...s trust store 3 The user then exports the public certificate to a USB disk from the eGUI 4 The user then imports the public certificate for OPC Client authentication to establish connection with OPC server The following steps will put the OPC UA client s certificate into the OPC UA server trust store Import and vice versa Export using the DynaCellect instrument s embedded Graphical User Interface ...

Page 104: ...ect Certificate 2 Plug in the USB disk with the OPC UA client certificate into the DynaCellect instrument 3 Select Import certificate Chapter 4 OPC UA interface Initial OPC UA Setup 4 104 CTS DynaCellect Magnetic Separation System User Guide ...

Page 105: ...ate from the USB drive dialog screen shown in the following image press Select and wait for the import process to complete Chapter 4 OPC UA interface Initial OPC UA Setup 4 CTS DynaCellect Magnetic Separation System User Guide 105 ...

Page 106: ...ord for OPC UA client authentication to the server 1 The user exports the OPC UA client application certificate and import it into the OPC server s trust store 2 The user will input the desired username and password for the first time in the eGUI 3 These credentials will be sent to instrument server and then to OPC server for storage 4 The user then uses these log in credentials from the OPC UA cl...

Page 107: ...ial through DynaCellect instrument s eGUI 1 From the OPC Mode dialog select Username Password 2 Plug in the USB disk with the OPC UA client certificate into the DynaCellect instrument Chapter 4 OPC UA interface Initial OPC UA Setup 4 CTS DynaCellect Magnetic Separation System User Guide 107 ...

Page 108: ... username and password to be used for authentication using the OPC UA client application Enable OPC UA The OPC UA interface is enabled using DynaCellect instrument s embedded Graphical User Interface eGUI following the instructions Chapter 4 OPC UA interface Enable OPC UA 4 108 CTS DynaCellect Magnetic Separation System User Guide ...

Page 109: ...m Setting menu press OPC Mode and select Done 2 OPC mode is enabled and the following dialog is displayed Chapter 4 OPC UA interface Enable OPC UA 4 CTS DynaCellect Magnetic Separation System User Guide 109 ...

Page 110: ...ectory DynaCellectProtocols of the USB disk 3 User can then import protocol via the import export settings from the OPC Mode dialog in the instrument s eGUI 4 The eGUI application will then copy the protocols files and protocol table YAML file into the OPC server s protocol directory The protocoltable yaml file must be created manually by the user and then copied in the same directory where the ex...

Page 111: ...the protocols using the DynaCellect instrument s eGUI application 1 Press Import Export from the OPC Mode screen 2 This step requires an admin user account Enter admin username and password then press Next Chapter 4 OPC UA interface Import protocol for OPC UA 4 CTS DynaCellect Magnetic Separation System User Guide 111 ...

Page 112: ...3 Press Import and then press Next in the following screens Chapter 4 OPC UA interface Import protocol for OPC UA 4 112 CTS DynaCellect Magnetic Separation System User Guide ...

Page 113: ...4 Wait for the import process to complete press Close Chapter 4 OPC UA interface Import protocol for OPC UA 4 CTS DynaCellect Magnetic Separation System User Guide 113 ...

Page 114: ...OPC UA interface Information model Chapter 4 OPC UA interface OPC UA interface 4 114 CTS DynaCellect Magnetic Separation System User Guide ...

Page 115: ...product name of the instrument LastMaintenanceDate String Read The last maintenance date for the instrument NextMaintenanceDate String Read The next maintenance date for the instrument InstrumentStatus String Read The instrument status InstrumentErrorDetails String Read The instrument error details InstrumentEnableMethod Boolean Read To determine if OPC control function is enabled or disabled Fals...

Page 116: ...l bag C label name Label D String Read The protocol bag D label name Label E String Read The protocol bag E label name Label F String Read The protocol bag F label name Label G String Read The protocol bag G label name Label H String Read The protocol bag H label name Label I String Read The protocol bag I label name Volume A UInt32 Read The protocol bag A volume number Volume B UInt32 Read The pr...

Page 117: ...ed UInt32 Read Run status Variable Type Access Values Description ElapsedTime UInt32 Read The total elapsed time of the run RemainingTime UInt32 Read The time remaining for current step run to complete RunActions String Read The latest instrument command RunDetails String Read The latest run information RunErrors String Read The latest run error RunID String Read The current run unique identifier ...

Page 118: ...le yaml that is imported into the instrument This is a required step before the user is able to load or perform a run LoadProtocol UInt16 0 1 Read write 0 unload 1 load This is a required step before the user can perform a run Prior to this the user will have to select the protocol index first StartProtocol UInt16 1 Read write start run PauseProtocol UInt16 0 1 Read write 0 resume 1 pause AbortPro...

Page 119: ...ith material contained in the equipment The instrument is properly decontaminated a if hazardous material is spilled onto or into the equipment and or b prior to having the instrument serviced at your facility or sending the instrument for repair maintenance trade in disposal or termination of a loan decontamination forms may be required from customer service Before using any cleaning or decontami...

Page 120: ...let module houses 2 10 A cartridge fuses 5 mm diameter 20 mm long time lag 250 VAC 10 Amp When required replacement of fuses is performed as follows 1 Confirm that the instrument power toggle is in the off position 2 Unplug the mains cable located at the back of the instrument near the power toggle Chapter 5 Maintenance Power and fuses 5 120 CTS DynaCellect Magnetic Separation System User Guide ...

Page 121: ...inside the housing to replace with new ones on both sides of the housing Check that the replacement fuse is the correct rating for your instrument see page 15 Note The placement inside the housing is as pictured Incorrect fuse placement will not work Chapter 5 Maintenance Power and fuses 5 CTS DynaCellect Magnetic Separation System User Guide 121 ...

Page 122: ...ck to the instrument 7 Close the cover over the housing 8 Re connect the mains cable and toggle the power to start up the instrument Chapter 5 Maintenance Power and fuses 5 122 CTS DynaCellect Magnetic Separation System User Guide ...

Page 123: ... instrument to Thermo Fisher Scientific for warranty issues or you wish to transport the instrument to another location repackage the unit as follows Note Prior to sending the instrument ensure the instrument is properly decontaminated if the instrument is exposed to any viable biological agents radioactive materials or hazardous chemicals toxic carcinogenic mutagenic toxic for reproduction sensit...

Page 124: ...oam 3 Tape the box securely and place appropriate shipping labels for shipping the instrument to Thermo Fisher Scientific Always transport the box with the unit in the upright position 4 If the instrument is not to be used for extended periods of time store the repackaged instrument in an upright position at 15 C to 30 C Chapter 5 Maintenance Repackaging the instrument 5 124 CTS DynaCellect Magnet...

Page 125: ...ad Removal Kit Cat No A52301 They are packaged in two bags that have both gone through gamma sterilization 1 CTS DynaCellect Cell Isolation Kit 2 CTS DynaCellect Bead Removal Kit 1 Unfold the Tyvek bags and remove the first layer of the bag by peeling off the Tyvek bag shown in the following image 6 CTS DynaCellect Magnetic Separation System User Guide 125 ...

Page 126: ...second layer of the Tyvek bag to clear off the packaging of the Single Use Kit 3 Loosen the tube holder from the catch at the back of the cassette Chapter 6 Basic instrument operation Unpack Single Use Kits 6 126 CTS DynaCellect Magnetic Separation System User Guide ...

Page 127: ...ecifically designed for single use functionally closed processing The CTS DynaCellect Cell Isolation Kit and CTS DynaCellect Bead Removal Kit use DEHP Free PVC specifically Tygon ND 100 65 size of 3 32 I D x 5 32 O D x 1 32 Wall to enable sterile welding to compatible bags using devices that service the blood bank industry such as the TSCD II Sterile Tubing Welder Terumo BCT See the instructions p...

Page 128: ... of 400 million target cells and bead removal of 1 L culture 1 2 Figure 8 Examples of consumable configurations 1 CTS DynaCellect Cell Isolation Kit 2 CTS DynaCellect Bead Removal Kit Chapter 6 Basic instrument operation Prepare consumables for a run 6 128 CTS DynaCellect Magnetic Separation System User Guide ...

Page 129: ...50 mL Terumo bag Spike to female luer with 10 cm tube G 40 mL CTS Dynabeads CD3 CD28 Conical bag Spike to female luer with 50 cm tube H 3 mL Supernatant 1 L Terumo bag N A I Empty Table 5 Bags used for the bead removal configuration Content Bag type Connectors Tube line Volume Cell output 2 1 L Terumo bag N A E Empty DPBS 1 HSA 1 L Terumo bag Spike to female luer with 10 cm tube G 350 mL Cells bea...

Page 130: ...ty CTS OpTmizer T Cell Expansion SFM bag with spike to female luer with 50 cm 19 7 tube Conical bag for bead input Input line welded with spike to female luer with 50 cm 19 7 tube VueLife clamp to limit bead movement Chapter 6 Basic instrument operation Prepare consumables for a run 6 130 CTS DynaCellect Magnetic Separation System User Guide ...

Page 131: ...cells Note All preparations of reagent bags with cells beads media etc must be prepared in a laminar flow hood to ensure sterility 1 Spike the 1 L Terumo bag with a spike to female luer with 10 cm 3 94 tube enables filling via luer lock syringe Chapter 6 Basic instrument operation Prepare consumables for a run 6 CTS DynaCellect Magnetic Separation System User Guide 131 ...

Page 132: ...spike to male luer with 50 cm 19 7 tube to add a weldable tubing Clamp off integrated tubing to avoid spill 3 Transfer fluid via luer lock syringe Chapter 6 Basic instrument operation Prepare consumables for a run 6 132 CTS DynaCellect Magnetic Separation System User Guide ...

Page 133: ...raining when running a protocol on the DynaCellect system 5 Spike the 150 mL Terumo bag with spike to female luer with 10 cm 3 94 tube to enable filling bag with cells via luer lock syringe Chapter 6 Basic instrument operation Prepare consumables for a run 6 CTS DynaCellect Magnetic Separation System User Guide 133 ...

Page 134: ... replaces the blunt tube end so that beads can be added via the luer lock syringe 3 With the luer lock beads can now be added to the bag via luer lock syringe The conical shape ensures beads sediment near the bag port reducing loss of beads Chapter 6 Basic instrument operation Prepare consumables for a run 6 134 CTS DynaCellect Magnetic Separation System User Guide ...

Page 135: ...h cells beads media etc must be prepared in a laminar flow hood to ensure sterility 1 Clamp the bag to limit the volume of the bead bag 2 Partially remove the cap Chapter 6 Basic instrument operation Prepare consumables for a run 6 CTS DynaCellect Magnetic Separation System User Guide 135 ...

Page 136: ...30 minutes at room temperature 4 Add air to the vial to ease the withdrawal of beads 5 Resuspend approximately 5 times before collecting beads Chapter 6 Basic instrument operation Prepare consumables for a run 6 136 CTS DynaCellect Magnetic Separation System User Guide ...

Page 137: ... side of the welder and the transfer bags on the other side of the welder Place the Single Use Kit tube in the welder use tube holder to find correct tube together with the bag tube and weld the bags to the Single Use Kit Chapter 6 Basic instrument operation Prepare consumables for a run 6 CTS DynaCellect Magnetic Separation System User Guide 137 ...

Page 138: ...side of the weld to keep filled bags clamped after welding 4 To keep track on tubes that are welded to the kit move them behind welder as shown in the previous picture before welding the next tube Chapter 6 Basic instrument operation Prepare consumables for a run 6 138 CTS DynaCellect Magnetic Separation System User Guide ...

Page 139: ...ngle Use Kit to the instrument using the bag hangers and the cassette handle 2 Attach the bag hanges onto the pole adaptors Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument 6 CTS DynaCellect Magnetic Separation System User Guide 139 ...

Page 140: ...ette are secured on the instrument 5 Route the isolation bag and tube behind the left pole Unlock the rocker lid from eGUI Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument 6 140 CTS DynaCellect Magnetic Separation System User Guide ...

Page 141: ...automatically Check that the lid is locked Secure tube in the tube guide on the rocker 8 Click the tube holder into position Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument 6 CTS DynaCellect Magnetic Separation System User Guide 141 ...

Page 142: ...he two pressure sensors the two bubble sensors the pump and the pinch valves 10 Install tubes in pressure sensors stretch while inserting Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument 6 142 CTS DynaCellect Magnetic Separation System User Guide ...

Page 143: ...ay into the recess of the pressure sensors and the bubble sensors 13 Insert the tube into the pump and close pump lid Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument 6 CTS DynaCellect Magnetic Separation System User Guide 143 ...

Page 144: ...tubes into all pinch valves 16 The tube holder the cassette and the pinch valves have letters to ensure correct placing of the tubing Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument 6 144 CTS DynaCellect Magnetic Separation System User Guide ...

Page 145: ... tubes and close pinch valves using eGUI 18 Correct installation of the fluidic panel Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument 6 CTS DynaCellect Magnetic Separation System User Guide 145 ...

Page 146: ... to ensure no kinks are present on the tubes 20 Remove open all clamps on the bags Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument 6 146 CTS DynaCellect Magnetic Separation System User Guide ...

Page 147: ...mp was to ensure no kinks on tubes are present 22 The system is now ready to run Chapter 6 Basic instrument operation Install CTS DynaCellect Cell Isolation Kit on the instrument 6 CTS DynaCellect Magnetic Separation System User Guide 147 ...

Page 148: ... Do not use kit if any such defect is found Install CTS DynaCellect Bead Removal Kit on the instrument The installation of the CTS DynaCellect Bead Removal Kit is similar to the CTS DynaCellect Cell Isolation Kit except for the placement of tubes in the tube guide As shown in the following figure there are two tubes to the reaction bag on the bead removal kit the isolation kit has one tube to the ...

Page 149: ...put output lines while the isolation kit has 8 input output lines The final installation of the CTS DynaCellect Bead Removal Kit is shown in the following figure Chapter 6 Basic instrument operation Install CTS DynaCellect Bead Removal Kit on the instrument 6 CTS DynaCellect Magnetic Separation System User Guide 149 ...

Page 150: ...ent Pinch Valves are engaged However manual clamps also represent a significant process hazard if left in the closed state Release all manual clamps prior to starting the automatic sequence See Run protocol on page 68 Chapter 6 Basic instrument operation Install CTS DynaCellect Bead Removal Kit on the instrument 6 150 CTS DynaCellect Magnetic Separation System User Guide ...

Page 151: ... bind c Transfer the supernatant with unbound non target cells to the supernatant bag 4 Wash T cells a Wash 3X to increase the purity of the isolated cells b Transfer the wash supernatant to the supernatant bag 5 Elute T cells and beads to output a Elute bead bound T cells in CTS OpTmizer T Cell Expansion SFM and transfer to the output bag Bead removal protocol overview High level workflow of bead...

Page 152: ...e Single Use Kit CAUTION Seal all fluid lines using a tube sealer or manual clamps prior to opening the pinch valves to prevent fluid movement when the instrument pinch valves are released 1 Seal off finished product from the Single Use Kit 2 From the home screen select Open valves Remove the tubes from the pinch valves Chapter 6 Basic instrument operation Remove Single Use Kit 6 152 CTS DynaCelle...

Page 153: ...me screen select Unlock rocker lid while pressing down the lid Remove reaction bag from the nest Note To relieve pressure from the reaction bag the pinch valves and the pump lid must be opened before before the rocker lid Chapter 6 Basic instrument operation Remove Single Use Kit 6 CTS DynaCellect Magnetic Separation System User Guide 153 ...

Page 154: ...gle Use Kit Create sterile seal and disconnect any bags or subassemblies 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 in...

Page 155: ...ol if The emergency stop button is activated Safety relay contacts welded or intermittent Power is cut off to the rocker and pump motor The leakage sensor detects fluid leaking in the nest Overfill detector detects overfilling of the bag in the nest One of the pressor sensors detects sustained pressure over the threshold An internal error of the pump drive rocker or valves is detected 7 CTS DynaCe...

Page 156: ...rument using the on off switch or disconnecting mains power Figure 9 Turn off the instrument using the on off switch or disconnecting mains power Stop all instrument functions by selecting Stop run Figure 10 Stop all instrument functions by pressing Stop run Restart after shut down Prior to restarting the DynaCellect instrument ensure that the condition that caused the shut down has been rectified...

Page 157: ...nufacturing situations with external run history monitoring qualified protocols specific to the point in the program where the triggering event for the shut down occurred can be initiated Jump start from a selected step is described at page 68 Where this isn t possible manual intervention may be required to re locate the fluid into a known bag and conduct a custom protocol to recover the reagents ...

Page 158: ...cause a hazard DynaCellect 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 safeguard...

Page 159: ...her Scientific representative if there is any doubt as to the use of the DynaCellect system CAUTION The CTS DynaCellect Single Use Kit Cat No A52300 and A52301 have been validated for one time use by customers Single Use Kits are not recommended to be washed re sterilized or reused as sterility and quality of these kits have not been validated for multiple uses Customers using DynaCellect Single U...

Page 160: ...Replace the fuses Consumable error e g kit leaking or tubes are occluded Consumable has been previously used Consumables are single use products Change to a new consumable Peristaltic pump Reduced flow or over pressure Check that all manual clamps are open Check that input and output vessels are connected to the correct fluid lines on the Single Use Kit Check tube connections such as tube welds ar...

Page 161: ...elds or otherwise pinched tubings Rocker lid not opening Too high pressure in reaction bag in the nest Open pinch valves and pump lid to release pressure Use manual mode to pump liquid air out of reaction bag Appendix A Troubleshooting Warnings and precautions A CTS DynaCellect Magnetic Separation System User Guide 161 ...

Page 162: ...Context State when the error condition may or will occur Startup error occurs during startup system initialization Recipe error occurs during recipe or protocol run Manual error occurs when system is in manual mode Idle erros occurs when system is idle Upgrade error occurs during software upgrade Description Provides more details on the error Recovery Action Provides tips or guidelines in recoveri...

Page 163: ...tware update file is not compatible with instrument Export service logs and send to tech support for further assistance 0x8865 Unable to power up instrument Startup Error was detected during power up sequence Power cycle and check if the instrument can self recover Export service logs and send to tech support for further assistance 0x8867 Unable to recover from upgrade failure Upgrade Error was de...

Page 164: ...ensors 0x8812 Pressure sensor is out of range Recipe Occlusion pressure sensor is out of detection range Ensure that the tube is stretched before inserting into pressure sensors 0x8813 Rocker bed leak detected Recipe Leak sensor in rocker nest detects a leak Check for leaks in rocker nest and clean the leak accordingly 0x8814 Pump is not closed Recipe Pump cover is not closed when starting a run E...

Page 165: ...xport service logs and send to tech support for further assistance 0x8817 Overfill detected Recipe Rocker bag overfill was detected during a recipe run Run is aborted Check protocol integrity Export service logs and send to tech support for further assistance Appendix B Error lists System error list B CTS DynaCellect Magnetic Separation System User Guide 165 ...

Page 166: ...stance 0x8064 Rocker motion error Recipe Manual Rocker motor exceeded the operating current limits Move rocker back to home using manual mode Check for obstructions during rocker motion 0x8065 Rocker home sensor error Startup Manual Rocker failed to home due to rocker home sensor error Export service logs and send to tech support for further assistance 0x8066 Rocker home position not valid Startup...

Page 167: ...age exceeded Startup Recipe Manual System voltage exceeded specification limits Export service logs and send to tech support for further assistance 0x8023 Leak detected Startup Recipe Manual Leak is detected in rocker nest Check for leaks in rocker nest and clean accordingly before restarting a run 0x8027 Pinch valve overcurrent detected Startup Recipe Manual Firmware detected an overcurrent condi...

Page 168: ...ct open state Export service logs and send to tech support for further assistance 0x8107 Pinch valve G failed to open Manual Recipe Pinch valve G position sensor failed to detect open state Export service logs and send to tech support for further assistance 0x8108 Pinch valve H failed to open Manual Recipe Pinch valve H position sensor failed to detect open state Export service logs and send to te...

Page 169: ...t close state Export service logs and send to tech support for further assistance 0x8206 Pinch valve F failed to close Manual Recipe Pinch valve F position sensor failed to detect close state Export service logs and send to tech support for further assistance 0x8207 Pinch valve G failed to close Manual Recipe Pinch valve G position sensor failed to detect close state Export service logs and send t...

Page 170: ...close state Export service logs and send to tech support for further assistance 0x8850 Subsystem module is not responding Startup Subsystem failed to respond to instrument controller at startup Export service logs and send to tech support for further assistance Appendix B Error lists VCB error list B 170 CTS DynaCellect Magnetic Separation System User Guide ...

Page 171: ... tech support for further assistance 0x8802 Magnet jack failed to move down Recipe Manual Magnet jack motor down position sensor failed to activate after move down command Export service logs and send to tech support for further assistance 0x8803 Magnet jack position sensors are both active Startup Recipe Manual Both magnet jack up and down position sensors are activated Export service logs and se...

Page 172: ... and extend position sensors are activated Export service logs and send to tech support for further assistance 0x8808 Bag lid height motors failed to home Recipe Manual Bag lid height motors failed to find its home position Export service logs and send to tech support for further assistance 0x8809 Peristaltic pump stall detected Startup Peristaltic pump motor sensors failed to detect rotation at s...

Page 173: ...tings About instrument to find out more information about the instrument e g software version Recommended instrument settings Select Menu Settings and access the Settings screen to configure the instrument C CTS DynaCellect Magnetic Separation System User Guide 173 ...

Page 174: ...ument name cannot have spaces Separate consecutive characters with a hyphen or underscore for example My_Instrument Date and time Select the Time zone field to set the time zone Select the Date format field to choose the date format and set the date Select the Time format field to activate the numeric editor to set the time Appendix C Recommended instrument settings Instrument settings administrat...

Page 175: ...rightness Use the slider to adjust the brightness of the touch screen Network confirguration Select the type of network connection that will be used to connect the instrument to the internet For details on using the Ethernet option see Connect the instrument to the internet on page 37 Appendix C Recommended instrument settings Instrument settings administrator only C CTS DynaCellect Magnetic Separ...

Page 176: ...gs to export the instrument service logs to a USB memory device Insert the USB memory device into the USB port before using this feature Select Run diagnostic tests to check the instrument hardware Administrator only Select Restore factory settings to reset the instrument to the original factory settings See page 123 Appendix C Recommended instrument settings Maintenance and service C 176 CTS Dyna...

Page 177: ...o display the entire list of runs performed by the instrument Select a particular file to view the details of that run Appendix C Recommended instrument settings Run history C CTS DynaCellect Magnetic Separation System User Guide 177 ...

Page 178: ...S without calcium chloride without magnesium chloride 2 L bag A1285602 CTS OpTmizer T Cell Expansion SFM no phenol red 1 L bottle A3705001 CTS OpTmizer T Cell Expansion SFM no phenol red 1 L bag A3705003 CTS OpTmizer T Cell Expansion SFM 1 L bottle A1048501 CTS OpTmizer T Cell Expansion SFM 1 L bag A1048503 CTS OpTmizer Pro SFM 1 L bottle A4966101 CTS OpTmizer Pro SFM 1 L bag A4966103 CTS IL 2 Rec...

Page 179: ...alve CBS OriGen Biomedical Vial spike with needle free valve VSV OriGen Biomedical One spike to one female luer with 10 cm of tubing and pinch clamp S F10 OriGen Biomedical One spike to one female luer with 50 cm SCD tubing and pinch clamp S F50 OriGen Biomedical One spike to one male luer with 50 cm SCD tubing and pinch clamp S M50 OriGen Biomedical Instruments CTS Rotea Counterflow Centrifugatio...

Page 180: ...priate personal protective equipment gloves gowns eye protection and so on To obtain SDSs visit thermofisher com support 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 potentially hazardous si...

Page 181: ...ty glasses or goggles Individuals 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 CAUTION Strong magnetic field CAUTION...

Page 182: ...ety labels Label and location Figure 11 Front view lid open Figure 12 Front view lid closed Figure 13 Rear view Appendix E Safety Symbols on this instrument E 182 CTS DynaCellect Magnetic Separation System User Guide ...

Page 183: ...isk of danger Consult the manual for further safety information CAUTION Risk of electrical shock WEEE Waste Electrical and Electronic Equipment symbol indicates that this product should not be disposed of in unsorted municipal waste Follow local municipal waste ordinances for proper disposal provisions to reduce the environmental impact of WEEE This instrument meets European requirement WEEE Direc...

Page 184: ... MISE EN GARDE Risque de danger Consulter le manuel pour d autres renseignements de sécurité MISE EN GARDE Risque de choc électrique Le symbole DEEE Déchets d équipements électriques et électroniques indique que ce produit ne doit pas être mis au rebut avec des déchets ménagers non triés Suivez la réglementation locale relative à l élimination des déchets usuels pour réduire l impact environnement...

Page 185: ...romagnétique Chine RoHS EFUP 25 Instrument safety General CAUTION Do not remove instrument protective covers If you remove the protective instrument panels or disable interlock devices you may be exposed to serious hazards including but not limited to severe electrical shock laser exposure crushing or chemical exposure If covers are removed do not use the instrument Contact Technical Support CAUTI...

Page 186: ...mfortable grip on the instrument or accessory Make sure that the path from where the object is to where it is being moved is clear of obstructions Do not lift an object and twist your torso at the same time Keep your spine in a good neutral position while lifting with your legs Participants should coordinate lift and move intentions with each other before lifting and carrying For smaller packages ...

Page 187: ...nical Support WARNING Disconnecting Power To fully disconnect power either detach or unplug the power cord positioning the instrument such that the power cord is accessible 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 res...

Page 188: ...e The instrument has a Pollution Degree rating of II The instrument may only be installed in an environment that has non conductive pollutants such as dust particles or wood chips Typical environments with a Pollution Degree II rating are laboratories and sales and commercial areas Electromagnetic compatibility EMC standards Class A notice This equipment has been tested and found to comply with th...

Page 189: ...y Immunity to proximity fields from RF wireless communications equipment IEC 61000 4 4 Electrical Fast Transient Burst Immunity IEC 61000 4 5 Surge Immunity IEC 61000 4 6 Immunity to conducted disturbances induced by RF fiedls IEC 61000 4 8 Power frequency Magnetic Field Immunity IEC 61000 4 11 Voltage Dips short Interruptions and Voltage Variation Immunity FCC Part 15 Subpart B 47 CFR U S Standar...

Page 190: ...be connected to the power mains using a 3 wire two conductors and ground power cable and plug Use this power cable with a properly grounded electrical outlet to avoid electrical shock Never operate the instrument with the ground disconnected Grounding continuity is required for safe operation of the instrument If extension cords or connector strips are implemented they must be checked on a regular...

Page 191: ...edical devices or medical implants are strongly advised to not transport the CTS DynaCellect Magnetic Separation System assemble or use the device without prior medical consultation in order to avoid possible health hazards EHS professionals should be consulted to further inspect the entire working area for possible risks and to provide additional safety instructions if necessary Optionally third ...

Page 192: ...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...

Page 193: ...ions The following references provide general guidelines when handling biological samples in laboratory environment U S Department of Health and Human Services Biosafety in Microbiological and Biomedical Laboratories BMBL 6th Edition HHS Publication No CDC 300859 Revised June 2020 https www cdc gov labs pdf CDC BiosafetymicrobiologicalBiomedicalLaboratories 2020 P pdf Laboratory biosafety manual f...

Page 194: ...the instrument close to the body Symbol Description DynaCellect instrument contains very strong permanent magnet The strong magnet can cause failure to the medical or electronic device Risk of the parts that move Keep fingers out of parts that move Symbol Description Some parts may move during service diagnostic and testing The parts that move can cause injury Risk of electrical shock Symbol Descr...

Page 195: ...ir packaging if not yet installed ESD can cause damage to instrument parts that are sensitive to ESD Return to use After service is performed use the diagnostic software to test perform qualification services and confirm instrument performance Appendix E Safety Service personnel E CTS DynaCellect Magnetic Separation System User Guide 195 ...

Page 196: ...tocols 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 condi...

Page 197: ......

Page 198: ... Magnetic Separation System_UG_MAN0026480 v3 GUID 111424C6 1723 4ACC A6E1 D826E6B805E6 2022 10 13 17 54 19 en 18 15 40 043 01 00 thermofisher com support thermofisher com askaquestion thermofisher com 13 October 2022 ...

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